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BMJ Open Aug 2022Increased exposure to digital devices as part of online classes increases susceptibility to visual impairments, particularly among school students taught using...
OBJECTIVES
Increased exposure to digital devices as part of online classes increases susceptibility to visual impairments, particularly among school students taught using e-learning strategies. This study aimed to identify the impact of remote learning during the COVID-19 lockdown on children's visual health.
DESIGN
Systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
DATA SOURCES
Scopus, PubMed and ScienceDirect databases from the year 2020 onwards.
ELIGIBILITY CRITERIA
We included cross-sectional, case-control, cohort studies, case series and case reports, published in English, Spanish or French, that approached the effects of remote learning during the COVID-19 lockdown on visual health in neurotypical children.
DATA EXTRACTION AND SYNTHESIS
We included a total of 21 articles with previous quality assessments using the Joanna Briggs checklist. Risk of bias assessment was applied using the National Institutes of Health quality assessment tool for before-and-after studies with no control group; the tool developed by Hoy to assess cross-sectional studies; the Murad tool to evaluate the methodological quality of case reports and case series; and the Newcastle-Ottawa Scale for cohort studies.
RESULTS
All but one study reported a deleterious impact of the COVID-19 lockdown on visual health in children. Overall, the most frequently identified ocular effects were refractive errors, accommodation disturbances and visual symptoms such as dry eye and asthenopia.
CONCLUSIONS
Increased dependence on digital devices for online classes has either induced or exacerbated visual disturbances, such as rapid progression of myopia, dry eye and visual fatigue symptoms, and vergence and accommodation disturbances, in children who engaged in remote learning during the COVID-19 lockdown.
PROSPERO REGISTRATION NUMBER
CRD42022307107.
Topics: COVID-19; Child; Communicable Disease Control; Cross-Sectional Studies; Humans; Learning; Schools; United States
PubMed: 35922104
DOI: 10.1136/bmjopen-2022-062388 -
BMJ Open Feb 2023Individuals with fetal alcohol spectrum disorder (FASD) are over-represented within the justice system and have significant employment challenges. The primary aim of... (Review)
Review
OBJECTIVES
Individuals with fetal alcohol spectrum disorder (FASD) are over-represented within the justice system and have significant employment challenges. The primary aim of this scoping review was to ascertain available employment resources for FASD individuals particularly those involved in the justice system. Secondary aims were to determine available evidence-based interventions for the justice workforce and employment providers.
METHODS
: That the resource was (a) published between 1990 and 2021, (b) in English, (c) available electronically in full text, (d) focused on strategies for improving employment outcomes of individuals with FASD and (f) developed for those aged over 15. Electronic searches of the following databases were conducted: EMBASE, MEDLINE, PsycINFO, Scopus, Web of Science and Google Scholar. Grey literature was collected via the databases ProQuest Dissertations & Theses Global, OpenGrey, GreyNet International and Grey Matters. Using Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews reporting guidelines, a five-stage methodological framework was employed. A quality appraisal of identified resources was conducted. Data were summarised qualitatively using a content analysis method that allowed for analysis of specific terms/themes/concepts/resource elements that resources covered, as well as a quantitative analysis of their frequency.
RESULTS
An initial search identified 850 articles, 512 of which were obtained through online database searches, 321 through Google Scholar searches and 17 through google searches. Sixteen resources were identified as meeting inclusion criteria, including four peer-reviewed papers and 12 grey literature resources. Six of the resources extracted were deemed 'good' or 'strong' quality, with the remainder-all grey literature resources-being 'adequate' or 'limited'. None of the resources identified were empirically evaluated or could be implemented synergistically. Content analysis revealed common themes addressing FASD-related employment challenges and required supports.
CONCLUSIONS
This review highlights the need for developing evidence-based employment-related resources for justice-involved people with FASD. Most of the 16 identified resources had a psychoeducational and advocacy component and described typical employment challenges with specific supports and accommodations to maximise workforce participation. However, none had been empirically evaluated, underscoring the importance of future research in this area to better inform more responsive and evidence-based employment-related programmes.
TRIAL REGISTRATION NUMBER
doi:10.17605/OSF.IO/J5VMB.
Topics: Humans; Female; Pregnancy; Aged; Fetal Alcohol Spectrum Disorders; Accommodation, Ocular; Databases, Factual; Electronics; Employment
PubMed: 36806062
DOI: 10.1136/bmjopen-2022-063860 -
The Cochrane Database of Systematic... Sep 2019Rheumatoid arthritis (RA) is a chronic, systemic, inflammatory, autoimmune disease that results in joint deformity and immobility of the musculoskeletal system. The...
BACKGROUND
Rheumatoid arthritis (RA) is a chronic, systemic, inflammatory, autoimmune disease that results in joint deformity and immobility of the musculoskeletal system. The major goals of treatment are to relieve pain, reduce inflammation, slow down or stop joint damage, prevent disability, and preserve or improve the person's sense of well-being and ability to function. Tai Chi, interchangeably known as Tai Chi Chuan, is an ancient Chinese health-promoting martial art form that has been recognized in China as an effective arthritis therapy for centuries. This is an update of a review published in 2004.
OBJECTIVES
To assess the benefits and harms of Tai Chi as a treatment for people with rheumatoid arthritis (RA).
SEARCH METHODS
We updated the search of CENTRAL, MEDLINE, Embase, and clinical trial registries from 2002 to September 2018.
SELECTION CRITERIA
We selected randomized controlled trials and controlled clinical trials examining the benefits (ACR improvement criteria or pain, disease progression, function, and radiographic progression), and harms (adverse events and withdrawals) of exercise programs with Tai Chi instruction or incorporating principles of Tai Chi philosophy. We included studies of any duration that included control groups who received either no therapy or alternate therapy.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
Adding three studies (156 additional participants) to the original review, this update contains a total of seven trials with 345 participants. Participants were mostly women with RA, ranging in age from 16 to 80 years, who were treated in outpatient settings in China, South Korea, and the USA. The majority of the trials were at high risk of bias for performance and detection bias, due to the lack of blinding of participants or assessors. Almost 75% of the studies did not report random sequence generation, and we judged the risk of bias as unclear for allocation concealment in the majority of studies. The duration of the Tai Chi programs ranged from 8 to 12 weeks.It is uncertain whether Tai Chi-based exercise programs provide a clinically important improvement in pain among Tai Chi participants compared to no therapy or alternate therapy. The change in mean pain in control groups, measured on visual analog scale (VAS 0 to 10 score, reduced score means less pain) ranged from a decrease of 0.51 to an increase of 1.6 at 12 weeks; in the Tai Chi groups, pain was reduced by a mean difference (MD) of -2.15 (95% confidence interval (CI) -3.19 to -1.11); 22% absolute improvement (95% CI, 11% to 32% improvement); 2 studies, 81 participants; very low-quality evidence, downgraded for imprecision, blinding and attrition bias.There was very low-quality evidence, downgraded for, blinding, and attrition, that was inconclusive for an important difference in disease activity, measured using Disease Activity Scale (DAS-28-ESR) scores (0 to 10 scale, lower score means less disease activity), with no change in the control group and 0.40 reduction (95% CI -1.10 to 0.30) with Tai Chi; 4% absolute improvement (95% CI 11% improvement to 3% worsening); 1 study, 43 participants.For the assessment of function, the change in mean Health Assessment Questionnaire (HAQ; 0 to 3 scale, lower score means better function) ranged from 0 to 0.1 in the control group, and reduced by MD 0.33 in the Tai Chi group (95% CI -0.79 to 0.12); 11% absolute improvement (95% CI 26% improvement to 4% worsening); 2 studies, 63 participants; very low-quality evidence, downgraded for imprecision, blinding, and attrition. We are unsure of an important improvement, as the results were inconclusive.Participants in Tai Chi programs were less likely than those in a control group to withdraw from studies at 8 to 12 weeks (19/180 in intervention groups versus 49/165 in control groups; risk ratio (RR) 0.40 (95% CI 0.19 to 0.86); absolute difference 17% fewer (95% CI 30% fewer to 3% fewer); 7 studies, 289 participants; low-quality evidence, downgraded for imprecision and blinding.There were no data available for radiographic progression. Short-term adverse events were not reported by group, but in two studies there was some narrative description of joint and muscle soreness and cramps; long-term adverse events were not reported.
AUTHORS' CONCLUSIONS
It is uncertain whether Tai Chi has any effect on clinical outcomes (joint pain, activity limitation, function) in RA, and important effects cannot be confirmed or excluded, since all outcomes had very low-quality evidence. Withdrawals from study were greater in the control groups than the Tai Chi groups, based on low-quality evidence. Although the incidence of adverse events is likely to be low with Tai Chi, we are uncertain, as studies failed to explicitly report such events. Few minor adverse events (joint and muscle soreness and cramps) were described qualitatively in the narrative of two of the studies. This updated review provides minimal change in the conclusions from the previous review, i.e. a pain outcome.
Topics: Arthralgia; Arthritis, Rheumatoid; Exercise Movement Techniques; Humans; Pain Management; Quality of Life; Randomized Controlled Trials as Topic; Tai Ji
PubMed: 31553478
DOI: 10.1002/14651858.CD004849.pub2 -
The Cochrane Database of Systematic... May 2018Various methods of conscious sedation and analgesia (CSA) have been used during oocyte retrieval for assisted reproduction. The choice of agent has been influenced by... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Various methods of conscious sedation and analgesia (CSA) have been used during oocyte retrieval for assisted reproduction. The choice of agent has been influenced by the quality of sedation and analgesia and by concerns about possible detrimental effects on reproductive outcomes.
OBJECTIVES
To assess the effectiveness and safety of different methods of conscious sedation and analgesia for pain relief and pregnancy outcomes in women undergoing transvaginal oocyte retrieval.
SEARCH METHODS
We searched; the Cochrane Gynaecology and Fertility specialised register, CENTRAL, MEDLINE, Embase, PsycINFO and CINAHL, and trials registers in November 2017. We also checked references, and contacted study authors for additional studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing different methods and administrative protocols for conscious sedation and analgesia during oocyte retrieval.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Our primary outcomes were intraoperative and postoperative pain. Secondary outcomes included clinical pregnancy, patient satisfaction, analgesic side effects, and postoperative complications.
MAIN RESULTS
We included 24 RCTs (3160 women) in five comparisons. We report the main comparisons below. Evidence quality was generally low or very low, mainly owing to poor reporting and imprecision.1. CSA versus other active interventions.All evidence for this comparison was of very low quality.CSA versus CSA plus acupuncture or electroacupunctureData show more effective intraoperative pain relief on a 0 to 10 visual analogue scale (VAS) with CSA plus acupuncture (mean difference (MD) 1.00, 95% confidence interval (CI) 0.18 to 1.82, 62 women) or electroacupuncture (MD 3.00, 95% CI 2.23 to 3.77, 62 women).Data also show more effective postoperative pain relief (0 to 10 VAS) with CSA plus acupuncture (MD 0.60, 95% CI -0.10 to 1.30, 61 women) or electroacupuncture (MD 2.10, 95% CI 1.40 to 2.80, 61 women).Evidence was insufficient to show whether clinical pregnancy rates were different between CSA and CSA plus acupuncture (odds ratio (OR) 0.61, 95% CI 0.20 to 1.86, 61 women). CSA alone may be associated with fewer pregnancies than CSA plus electroacupuncture (OR 0.22, 95% CI 0.07 to 0.66, 61 women).Evidence was insufficient to show whether rates of vomiting were different between CSA and CSA plus acupuncture (OR 1.64, 95% CI 0.46 to 5.88, 62 women) or electroacupuncture (OR 1.09, 95% CI 0.33 to 3.58, 62 women).Trialists provided no usable data for other outcomes of interest.CSA versus general anaesthesia Postoperative pain relief was greater in the CSA group (0 to 3 Likert: mean difference (MD) 1.9, 95% CI 2.24 to 1.56, one RCT, 50 women).Evidence was insufficient to show whether groups differed in clinical pregnancy rates (OR 1.00, 95% CI 0.43 to 2.35, two RCTs, 108 women, I = 0%).Evidence was insufficient to show whether groups differed in rates of vomiting (OR 0.46, 95% CI 0.08 to 2.75, one RCT, 50 women) or airway obstruction (OR 0.14, 95% CI 0.02 to 1.22, one RCT, 58 women). Fewer women needed mask ventilation in the CSA group (OR 0.05, 95% CI 0.01 to 0.20, one RCT, 58 women).Evidence was also insufficient to show whether groups differed in satisfaction rates (OR 0.66, 95% CI 0.11 to 4.04, two RCTs, 108 women, I = 34%; very low-quality evidence).Trialists provided no usable data for outcomes of interest.2. CSA + paracervical block (PCB) versus other interventions.CSA + PCB versus electroacupuncture + PCB Intraoperative pain scores were lower in the CSA + PCB group (0 to 10 VAS: MD -0.66, 95% CI -0.93 to -0.39, 781 women, I = 76%; low-quality evidence).Evidence was insufficient to show whether groups differed in clinical pregnancy rates (OR 0.96, 95% CI 0.72 to 1.29, 783 women, I = 9%; low-quality evidence).Trialists provided no usable data for other outcomes of interest.CSA + PCB versus general anaesthesiaEvidence was insufficient to show whether groups differed in postoperative pain scores (0 to 10 VAS: MD 0.49, 95% CI -0.13 to 1.11, 50 women; very low-quality evidence).Evidence was insufficient to show whether groups differed in clinical pregnancy rates (OR 0.70, 95% CI 0.22 to 2.26, 51 women; very low-quality evidence).Trialists provided no usable data for other outcomes of interest.CSA + PCB versus spinal anaesthesiaPostoperative pain scores were higher in the CSA + PCB group (0 to 10 VAS: MD 1.02, 95% CI 0.48 to 1.56, 36 women; very low-quality evidence).Evidence was insufficient to show whether groups differed in clinical pregnancy rates (OR 0.93, 95% CI 0.24 to 3.65, 38 women; very low-quality evidence).Trialists provided no usable data for other outcomes of interest.CSA + PCB versus PCBEvidence was insufficient to show whether groups differed in clinical pregnancy rates (OR 0.93, 95% CI 0.44 to 1.96, 150 women; low-quality evidence) or satisfaction (OR 1.63, 95% CI 0.68 to 3.89, 150 women, low-quality evidence).Trialists provided no usable data for other outcomes of interest.CSA + PCB versus CSA only Evidence was insufficient to show whether groups differed in clinical pregnancy rates (OR 0.62, 95% CI 0.28 to 1.36, one RCT, 100 women; very low-quality evidence). Rates of postoperative nausea and vomiting were lower in the CS + PCB group (OR 0.42, 95% CI 0.18 to 0.97, two RCTs, 140 women, I = 40%; very low-quality evidence).Trialists provided no usable data for other outcomes of interest.
AUTHORS' CONCLUSIONS
The evidence does not support one particular method or technique over another in providing effective conscious sedation and analgesia for pain relief during and after oocyte retrieval. Simultaneous use of sedation combined with analgesia such as the opiates, further enhanced by paracervical block or acupuncture techniques, resulted in better pain relief than occurred with one modality alone. Evidence was insufficient to show conclusively whether any of the interventions influenced pregnancy rates. All techniques reviewed were associated with a high degree of patient satisfaction. Women's preferences and resource availability for choice of pain relief merit consideration in practice.
Topics: Analgesia; Anesthesia, General; Conscious Sedation; Electroacupuncture; Female; Fertilization in Vitro; Humans; Oocyte Retrieval; Pain Measurement; Pain, Procedural; Pregnancy; Pregnancy Outcome; Pregnancy Rate; Randomized Controlled Trials as Topic
PubMed: 29761478
DOI: 10.1002/14651858.CD004829.pub4 -
The Cochrane Database of Systematic... Jun 2020Presbyopia occurs when the lens of the eyes loses its elasticity leading to loss of accommodation. The lens may also progress to develop cataract, affecting visual... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Presbyopia occurs when the lens of the eyes loses its elasticity leading to loss of accommodation. The lens may also progress to develop cataract, affecting visual acuity and contrast sensitivity. One option of care for individuals with presbyopia and cataract is the use of multifocal or extended depth of focus intraocular lens (IOL) after cataract surgery. Although trifocal and bifocal IOLs are designed to restore three and two focal points respectively, trifocal lens may be preferable because it restores near, intermediate, and far vision, and may also provide a greater range of useful vision and allow for greater spectacle independence in individuals with presbyopia.
OBJECTIVES
To assess the effectiveness and safety of implantation with trifocal versus bifocal IOLs during cataract surgery among participants with presbyopia.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2019, Issue 9); Ovid MEDLINE; Embase.com; PubMed; ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 26 September 2019. We searched the reference lists of the retrieved articles and the abstracts from the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) for the years 2005 to 2015.
SELECTION CRITERIA
We included randomized controlled trials that compared trifocal and bifocal IOLs among participants 30 years or older with presbyopia undergoing cataract surgery.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methodology.
MAIN RESULTS
We identified five studies conducted in Europe with a total of 175 participants. All five studies assessed uncorrected distance visual acuity (primary outcome of the review), while some also examined our secondary outcomes including uncorrected near, intermediate, and best-corrected distance visual acuity, as well as contrast sensitivity. Study characteristics All participants had bilateral cataracts with no pre-existing ocular pathologies or ocular surgery. Participants' mean age ranged from 58 to 64 years. Only one study reported on gender of participants, and they were mostly women. We assessed all the included studies as being at unclear risk of bias for most domains. Two studies received financial support from manufacturers of lenses evaluated in this review, and at least one author of another study reported receiving payments for delivering lectures with lens manufacturers. Findings All studies compared trifocal versus bifocal IOL implantation on visual acuity outcomes measured on a LogMAR scale. At one year, trifocal IOL showed no evidence of effect on uncorrected distance visual acuity (mean difference (MD) 0.00, 95% confidence interval (CI) -0.04 to 0.04; I = 0%; 2 studies, 107 participants; low-certainty evidence) and uncorrected near visual acuity (MD 0.01, 95% CI -0.04 to 0.06; I = 0%; 2 studies, 107 participants; low-certainty evidence). Trifocal IOL implantation may improve uncorrected intermediate visual acuity at one year (MD -0.16, 95% CI -0.22 to -0.10; I= 0%; 2 studies, 107 participants; low-certainty evidence), but showed no evidence of effect on best-corrected distance visual acuity at one year (MD 0.00, 95% CI -0.03 to 0.04; I= 0%; 2 studies, 107 participants; low-certainty evidence). No study reported on contrast sensitivity or quality of life at one-year follow-up. Data from one study at three months suggest that contrast sensitivity did not differ between groups under photopic conditions, but may be worse in the trifocal group in one of the four frequencies under mesopic conditions (MD -0.19, 95% CI -0.33 to -0.05; 1 study; I = 0%, 25 participants; low-certainty evidence). In two studies, the investigators observed that participants' satisfaction or spectacle independence may be higher in the trifocal group at six months, although another study found no evidence of a difference in participant satisfaction or spectacle independence between groups. Adverse events Adverse events reporting varied among studies. Two studies reported information on adverse events at one year. One study reported that participants showed no intraoperative or postoperative complications, while the other study reported that four eyes (11.4%) in the bifocal and three eyes (7.5%) in the trifocal group developed significant posterior capsular opacification requiring YAG capsulotomy. The certainty of the evidence was low.
AUTHORS' CONCLUSIONS
There is low-certainty of evidence that compared to bifocal IOL, implantation of trifocal IOL may improve uncorrected intermediate visual acuity at one year. However, there is no evidence of a difference between trifocal and bifocal IOL for uncorrected distance visual acuity, uncorrected near visual acuity, and best-corrected visual acuity at one year. Future research should include the comparison of both trifocal IOL and specific bifocal IOLs that correct intermediate visual acuity to evaluate important outcomes such as contrast sensitivity and quality of life.
Topics: Capsule Opacification; Cataract Extraction; Confidence Intervals; Contrast Sensitivity; Female; Humans; Lens Implantation, Intraocular; Male; Middle Aged; Multifocal Intraocular Lenses; Postoperative Complications; Presbyopia; Time Factors; Visual Acuity
PubMed: 32584432
DOI: 10.1002/14651858.CD012648.pub2 -
The Cochrane Database of Systematic... Aug 2015Postoperative vitreous cavity haemorrhage (POVCH) is a significant complication following vitrectomy for proliferative diabetic retinopathy (PDR). It delays visual... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Postoperative vitreous cavity haemorrhage (POVCH) is a significant complication following vitrectomy for proliferative diabetic retinopathy (PDR). It delays visual recovery and can make further treatment difficult if the view of the fundus is significantly obscured. A number of interventions to reduce the incidence of POVCH have been proposed, including the perioperative use of anti-vascular endothelial growth factor (anti-VEGF). Anti-VEGFs reduce vascular proliferation and the vascularity of neovascular tissue, which is often the source of bleeding following vitrectomy.
OBJECTIVES
This updated review aimed to summarise the effects of anti-VEGF use to reduce the occurrence of POVCH after vitrectomy surgery for PDR.
SEARCH METHODS
We 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), PubMed (January 1966 to May 2015), EMBASE (January 1980 to May 2015), Latin American and Caribbean Health Sciences (LILACS) (January 1982 to May 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), and the 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 26 May 2015.
SELECTION CRITERIA
We included all randomised controlled trials (RCTs) and quasi-RCTs that looked at the use of anti-VEGFs and the incidence of POVCH in people undergoing vitrectomy for PDR.
DATA COLLECTION AND ANALYSIS
Both review authors independently assessed and extracted the data. We used standard methodological procedures expected by Cochrane.The primary outcomes of the review were the incidence of early and late POVCH following perioperative anti-VEGF administration. Secondary outcomes included best-corrected visual acuity at six months following surgery, the incidence of vitreous cavity washout or revision vitrectomy at six months, adverse effects of intervention (cataract, iris rubeosis and rubeotic glaucoma, retinal detachment, increased inflammation and systemic side effects), quality of life measures performed at least six months following vitrectomy, and density of POVCH.
MAIN RESULTS
The current review included 12 RCTs that looked at the pre- or intraoperative use of intravitreal bevacizumab to prevent postoperative vitreous haemorrhage during pars plana vitrectomy for complications of PDR. The studies were conducted in a variety of countries (three from Iran, two from Italy, two from Egypt, and the remaining from South Korea, USA, Mexico, Pakistan, and Japan). The inclusion criteria for entry into the studies were standard complications of proliferative retinopathy: non-clearing vitreous haemorrhage, tractional retinal detachment involving the macula, or combined tractional rhegmatogenous detachment. The included studies randomised a total of 654 eyes. The average age of the participants was 54 years.We identified methodological issues in all included studies. Risk of bias was highest for masking of participants and investigators (four studies were an 'open label' design), and a number of studies were unclear when describing randomisation methods and sequence allocation.Participants receiving intravitreal bevacizumab in addition to pars plana vitrectomy were less likely to experience early POVCH (grade 2) compared to people undergoing pars plana vitrectomy alone (risk ratio (RR) 0.28, 95% confidence interval (CI) 0.08 to 0.96, 2 studies, 144 eyes, high-quality evidence). This corresponds to an absolute effect of 130 fewer people (95% CI 167 fewer to 7 fewer) with early POVCH per 1000 people when treated with intravitreal bevacizumab. We saw similar results for all grades of POVCH (RR 0.35, 95% CI 0.23 to 0.53, 9 studies, 512 eyes) and when excluding cases where assessment of outcome was impossible due to presence of silicone oil (RR 0.34, 95% CI 0.19 to 0.60, 6 studies, 302 eyes).The effect of pre- or intraoperative intravitreal bevacizumab on the incidence of late postoperative haemorrhage was uncertain (RR 0.72, 95% CI 0.30 to 1.72, 3 studies, 196 eyes, low-quality evidence). The absolute effect was 55 fewer people (95% CI 138 fewer to 143 more) with late POVCH per 1000 people when treated with intravitreal bevacizumab. This outcome was rarer and was only reported in a few studies. We are currently unable to provide an estimate of the effect of intravitreal bevacizumab on postoperative visual acuity due to significant study heterogeneity.No local or systemic complications of intravitreal bevacizumab were reported by the RCTs. The risk of postoperative retinal detachment was lower in the participants treated with pre- or intraoperative bevacizumab (RR 0.46, 95% CI 0.19 to 1.08, 7 studies, 372 participants, low-quality evidence); the absolute effect was 49 fewer people (95% CI:73 fewer to 8 more) with postoperative retinal detachment per 1000 people when treated with intravitreal bevacizumab.
AUTHORS' CONCLUSIONS
The use of pre- or intraoperative bevacizumab lowers the incidence of early POVCH. The reported complications from its use appear to be low. Futher randomised studies that look at other anti-VEGF medications are ongoing and will strengthen the current review findings, giving both surgeons and patients evidence to guide treatment choices in the management of proliferative retinopathy.
Topics: Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Bevacizumab; Diabetic Retinopathy; Humans; Intravitreal Injections; Postoperative Hemorrhage; Preoperative Care; Randomized Controlled Trials as Topic; Vascular Endothelial Growth Factor A; Vascular Endothelial Growth Factors; Vitrectomy; Vitreous Hemorrhage
PubMed: 26250103
DOI: 10.1002/14651858.CD008214.pub3 -
Archives of Disease in Childhood. Fetal... Jul 2020Neonatal research evaluates many different outcomes using multiple measures. This can prevent synthesis of trial results in meta-analyses, and selected outcomes may not...
BACKGROUND
Neonatal research evaluates many different outcomes using multiple measures. This can prevent synthesis of trial results in meta-analyses, and selected outcomes may not be relevant to former patients, parents and health professionals.
OBJECTIVE
To define a core outcome set (COS) for research involving infants receiving neonatal care in a high-income setting.
DESIGN
Outcomes reported in neonatal trials and qualitative studies were systematically reviewed. Stakeholders were recruited for a three-round international Delphi survey. A consensus meeting was held to confirm the final COS, based on the survey results.
PARTICIPANTS
Four hundred and fourteen former patients, parents, healthcare professionals and researchers took part in the eDelphi survey; 173 completed all three rounds. Sixteen stakeholders participated in the consensus meeting.
RESULTS
The literature reviews identified 104 outcomes; these were included in round 1. Participants proposed 10 additional outcomes; 114 outcomes were scored in rounds 2 and 3. Round 1 scores showed different stakeholder groups prioritised contrasting outcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotising enterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability, quality of life, adverse events, visual impairment/blindness, hearing impairment/deafness, retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia.
CONCLUSIONS AND RELEVANCE
A COS for clinical trials and other research studies involving infants receiving neonatal care in a high-income setting has been identified. This COS for neonatology will help standardise outcome selection in clinical trials and ensure these are relevant to those most affected by neonatal care.
Topics: Biomedical Research; Humans; Infant; Neonatology; Outcome Assessment, Health Care
PubMed: 31732683
DOI: 10.1136/archdischild-2019-317501 -
The Cochrane Database of Systematic... Jul 2019Cough both protects and clears the airway. Cough has three phases: breathing in (inspiration), closure of the glottis, and a forced expiratory effort. Chronic cough has...
BACKGROUND
Cough both protects and clears the airway. Cough has three phases: breathing in (inspiration), closure of the glottis, and a forced expiratory effort. Chronic cough has a negative, far-reaching impact on quality of life. Few effective medical treatments for individuals with unexplained (idiopathic/refractory) chronic cough (UCC) are known. For this group, current guidelines advocate the use of gabapentin. Speech and language therapy (SLT) has been considered as a non-pharmacological option for managing UCC without the risks and side effects associated with pharmacological agents, and this review considers the evidence from randomised controlled trials (RCTs) evaluating the effectiveness of SLT in this context.
OBJECTIVES
To evaluate the effectiveness of speech and language therapy for treatment of people with unexplained (idiopathic/refractory) chronic cough.
SEARCH METHODS
We searched the Cochrane Airways Trials Register, CENTRAL, MEDLINE, Embase, CINAHL, trials registries, and reference lists of included studies. Our most recent search was 8 February 2019.
SELECTION CRITERIA
We included RCTs in which participants had a diagnosis of UCC having undergone a full diagnostic workup to exclude an underlying cause, as per published guidelines or local protocols, and where the intervention included speech and language therapy techniques for UCC.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened the titles and abstracts of 94 records. Two clinical trials, represented in 10 study reports, met our predefined inclusion criteria. Two review authors independently assessed risk of bias for each study and extracted outcome data. We analysed dichotomous data as odds ratios (ORs), and continuous data as mean differences (MDs) or geometric mean differences. We used standard methods recommended by Cochrane. Our primary outcomes were health-related quality of life (HRQoL) and serious adverse events (SAEs).
MAIN RESULTS
We found two studies involving 162 adults that met our inclusion criteria. Neither of the two studies included children. The duration of treatment and length of sessions varied between studies from four sessions delivered weekly, to four sessions over two months. Similarly, length of sessions varied slightly from one 60-minute session and three 45-minute sessions to four 30-minute sessions. The control interventions were healthy lifestyle advice in both studies.One study contributed HRQoL data, using the Leicester Cough Questionnaire (LCQ), and we judged the quality of the evidence to be low using the GRADE approach. Data were reported as between-group difference from baseline to four weeks (MD 1.53, 95% confidence interval (CI) 0.21 to 2.85; participants = 71), revealing a statistically significant benefit for people receiving a physiotherapy and speech and language therapy intervention (PSALTI) versus control. However, the difference between PSALTI and control was not observed between week four and three months. The same study provided information on SAEs, and there were no SAEs in either the PSALTI or control arms. Using the GRADE approach we judged the quality of evidence for this outcome to be low.Data were also available for our prespecified secondary outcomes. In each case data were provided by only one study, therefore there were no opportunities for aggregation; we judged the quality of this evidence to be low for each outcome. A significant difference favouring therapy was demonstrated for: objective cough counts (ratio for mean coughs per hour on treatment was 59% (95% CI 37% to 95%) relative to control; participants = 71); symptom score (MD 9.80, 95% CI 4.50 to 15.10; participants = 87); and clinical improvement as defined by trialists (OR 48.13, 95% CI 13.53 to 171.25; participants = 87). There was no significant difference between therapy and control regarding subjective measures of cough (MD on visual analogue scale of cough severity: -9.72, 95% CI -20.80 to 1.36; participants = 71) and cough reflex sensitivity (capsaicin concentration to induce five coughs: 1.11 (95% CI 0.80 to 1.54; participants = 49) times higher on treatment than on control). One study reported data on adverse events, and there were no adverse events reported in either the therapy or control arms of the study.
AUTHORS' CONCLUSIONS
The paucity of data in this review highlights the need for more controlled trial data examining the efficacy of SLT interventions in the management of UCC. Although a large number of studies were found in the initial search as per protocol, we could include only two studies in the review. In addition, this review highlights that endpoints vary between published studies.The improvements in HRQoL (LCQ) and reduction in 24-hour cough frequency seen with the PSALTI intervention were statistically significant but short-lived, with the between-group difference lasting up to four weeks only. Further studies are required to replicate these findings and to investigate the effects of SLT interventions over time. It is clear that SLT interventions vary between studies. Further research is needed to understand which aspects of SLT interventions are most effective in reducing cough (both objective cough frequency and subjective measures of cough) and improving HRQoL. We consider these endpoints to be clinically important. It is also important for future studies to report information on adverse events.Because of the paucity of data, we can draw no robust conclusions regarding the efficacy of SLT interventions for improving outcomes in unexplained chronic cough. Our review identifies the need for further high-quality research, with comparable endpoints to inform robust conclusions.
Topics: Chronic Disease; Cough; Humans; Language Therapy; Physical Therapy Modalities; Randomized Controlled Trials as Topic; Speech Therapy
PubMed: 31335963
DOI: 10.1002/14651858.CD013067.pub2 -
The Cochrane Database of Systematic... Jan 2020Survival for stage I to III, hormone receptor-positive, breast cancer has substantially improved over time due to advances in screening, surgery and adjuvant therapy.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Survival for stage I to III, hormone receptor-positive, breast cancer has substantially improved over time due to advances in screening, surgery and adjuvant therapy. However many adjuvant therapies have significant treatment-related toxicities, which worsen quality of life for breast cancer survivors. Postmenopausal women with hormone receptor-positive breast cancer are now prescribed aromatase inhibitors (AI) as standard, with longer durations of therapy, up to 10 years, being considered for certain women. AI treatment is associated with a high incidence of AI-induced musculoskeletal symptoms (AIMSS), often described as symmetrical pain and soreness in the joints, musculoskeletal pain and joint stiffness. AIMSS reduces compliance with AI therapy in up to one half of women undergoing adjuvant AI therapy, potentially compromising breast cancer outcomes. Exercise has been investigated for the prevention and treatment of AIMSS but the effect of this intervention remains unclear.
OBJECTIVES
To assess the effects of exercise therapies on the prevention or management of aromatase inhibitor-induced musculoskeletal symptoms (AIMSS) in women with stage I to III hormone receptor-positive breast cancer.
SEARCH METHODS
We searched Cochrane Breast Cancer's Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases up to 13 December 2018. We also searched two conference proceedings portals and two clinical trials registries for ongoing studies or unpublished trials, or both, in August 2019. We also reviewed reference lists of the included studies.
SELECTION CRITERIA
We included randomised controlled trials that compared exercise versus a comparator arm. We did not impose any restriction on the comparator arm, which could include an alternative type of exercise, no exercise or a waiting list control. Both published and non-peer-reviewed studies were eligible.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data, assessed risk of bias and certainty of the evidence using the GRADE approach. The outcomes investigated were pain, joint stiffness, grip strength, health-related quality of life, cancer-specific quality of life, adherence to AI therapy, adverse events, incidence of AIMSS, breast cancer-specific survival and overall survival. For continuous outcomes that were assessed with the same instrument, we used the mean difference (MD); for those outcomes that used different instruments, we used the standardised mean difference (SMD) for the analysis. For dichotomous outcomes, we reported outcomes as an odds ratio (OR).
MAIN RESULTS
We included seven studies with 400 randomised participants; one study assessed exercise for preventing AIMSS and six studies assessed treating AIMSS. For preventing AIMSS, the single study reported no difference in pain scores, grip strength or compliance to taking AI medication between groups. Data values were not provided in the study and no other outcomes were reported. For managing AIMSS, we found that the evidence for the effect of exercise therapies on overall change in worst pain scores was very uncertain (SMD -0.23, 95% confidence interval (CI) -0.78 to 0.32; 4 studies, 284 women; very low-certainty evidence). The evidence suggested that exercise therapies result in little to no difference in overall change in stiffness scores (Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) stiffness score MD -0.76, 95% CI -1.67 to 0.15 and Visual Analogues Scale (VAS) stiffness score MD -0.42, 95% CI -2.10 to 1.26; 1 study, 53 women; low-certainty evidence). The evidence was very uncertain for the outcomes of overall change in grip strength (MD 0.30, 95% CI -0.55 to 1.15; 1 study, 83 women; very low-certainty evidence); overall change in health-related quality of life (subscales of SF-36 tool ranged from least benefit of MD 1.88, 95% CI -2.69 to 6.45 to most benefit of MD 9.70, 95% CI 1.67 to 17.73; 2 studies, 123 women, very low-certainty evidence); overall change in cancer-specific quality of life (MD 4.58, 95% CI -0.61 to 9.78; 2 studies, 136 women; very low-certainty evidence); and adherence to aromatase inhibitors (OR 2.43, 95% CI 0.41 to 14.63; 2 studies, 224 women; very low-certainty evidence). There were no adverse events identified across four studies in either arm (0 events reported; 4 studies; 331 participants; low-certainty evidence). There were no data reported on incidence of AIMSS, breast cancer-specific survival or overall survival.
AUTHORS' CONCLUSIONS
Given the wide-ranging benefits of exercise for people affected by cancer, it was surprising that this review provided no clear evidence of benefit for exercise therapies in women with early breast cancer with AIMSS. This review only yielded seven eligible studies with 400 participants, which is likely to have underpowered the findings. The meta-analysis was challenging due to the considerable heterogeneity amongst the trials, with a wide range of exercise regimens and follow-up periods. Despite these inconclusive findings, exercise needs to be part of routine care for women with breast cancer due to its wide-ranging benefits. Future research in this area would be enhanced with further understanding of the mechanism of AIMSS, a single clear definition of the condition, and phase III randomised controlled trials that are adequately powered to test targeted exercise interventions on the key clinical outcomes in this condition.
Topics: Aromatase Inhibitors; Breast Neoplasms; Exercise Therapy; Female; Humans; Musculoskeletal Pain; Neoplasm Staging; Randomized Controlled Trials as Topic
PubMed: 31994181
DOI: 10.1002/14651858.CD012988.pub2