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The Cochrane Database of Systematic... Jun 2020Infectious keratitis is an infection of the cornea that can be caused by bacteria, viruses, fungi, protozoa, or parasites. It may be associated with ocular surgery,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Infectious keratitis is an infection of the cornea that can be caused by bacteria, viruses, fungi, protozoa, or parasites. It may be associated with ocular surgery, trauma, contact lens wear, or conditions that cause deficiency or loss of corneal sensation, or suppression of the immune system, such as diabetes, chronic use of topical steroids, or immunomodulatory therapies. Photoactivated chromophore for collagen cross-linking (PACK-CXL) of the cornea is a therapy that has been successful in treating eye conditions such as keratoconus and corneal ectasia. More recently, PACK-CXL has been explored as a treatment option for infectious keratitis.
OBJECTIVES
To determine the comparative effectiveness and safety of PACK-CXL with standard therapy versus standard therapy alone for the treatment of bacterial keratitis.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2019, Issue 7); Ovid MEDLINE; Embase.com; PubMed; Latin American and Caribbean Health Science Information database (LILACS); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 8 July 2019.
SELECTION CRITERIA
We included randomized controlled trials (RCTs), quasi-RCTs, and controlled clinical trials (CCTs) of PACK-CXL for bacterial keratitis. We included quasi-RCTs and CCTs as we anticipated that there would not be many RCTs eligible for inclusion.
DATA COLLECTION AND ANALYSIS
Two review authors working independently selected studies for inclusion in the review, assessed trials for risk of bias, and extracted data. The primary outcome was proportion of participants with complete healing at four to eight weeks. Secondary outcomes included visual acuity, morphology, adverse events, and treatment failure at four to eight weeks.
MAIN RESULTS
We included three trials (two RCTs and one quasi-RCT) in this review for a total of 59 participants (59 eyes) with bacterial keratitis. Trials were all single-center and were conducted in Egypt, Iran, and Thailand between 2010 and 2014. It is very uncertain whether PACK-CXL with standard antibiotic therapy is more effective than standard antibiotic therapy alone for re-epithelialization and complete healing (risk ratio (RR) 1.53, 95% confidence interval (CI) 0.88 to 2.66; participants = 15). We judged the certainty of the evidence to be very low due to the small sample size and high risk of selection and performance bias. The high risk of selection bias reflects the overall review. Masking of participants was not possible for the surgical arm. No participant had a best-corrected visual acuity of 20/100 or better at eight weeks (very low certainty evidence). There is also no evidence that use of PACK-CXL with standard therapy results in fewer instances of treatment failure than standard therapy alone (RR 0.50, 95% CI 0.05 to 4.98; participants = 32). We judged the certainty of evidence to be low due to the small sample size and high risk of selection bias. There were no adverse events reported at 14 days (low certainty evidence). Data on other outcomes, such as visual acuity and morphological characteristics, could not be compared because of variable time points and specific metrics.
AUTHORS' CONCLUSIONS
The current evidence on the effectiveness of PACK-CXL for bacterial keratitis is of low certainty and clinically heterogenous in regard to outcomes. There are five ongoing RCTs enrolling 1136 participants that may provide better answers in the next update of this review. Any future research should include subgroup analyses based on etiology. A core outcomes set would benefit healthcare decision-makers in comparing and understanding study data.
Topics: Anti-Bacterial Agents; Collagen; Eye Infections, Bacterial; Humans; Keratitis; Photosensitizing Agents; Randomized Controlled Trials as Topic; Riboflavin; Ultraviolet Therapy; Visual Acuity
PubMed: 32557558
DOI: 10.1002/14651858.CD013001.pub2 -
Breast Cancer Research and Treatment Aug 2020Hormone replacement therapy (HRT) is used to reduce climacteric symptoms of menopause and prevent osteoporosis; however, it increases risk of breast cancer. Mammographic...
PURPOSE
Hormone replacement therapy (HRT) is used to reduce climacteric symptoms of menopause and prevent osteoporosis; however, it increases risk of breast cancer. Mammographic density (MD) is also a strong risk factor for breast cancer. We conducted this review to investigate the association between HRT use and MD and to assess the effect of different HRT regimens on MD.
METHODS
Two of authors examined articles published between 2002 and 2019 from PubMed, Embase, and OVID using Covidence systematic review platform. Any disagreements were discussed until consensus was reached. The protocol used in this review was created in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Quality of each eligible study was assessed using the Oxford Center for Evidence-Based Medicine (OCEBM) hierarchy.
RESULTS
Twenty-two studies met the inclusion criteria. Six studies showed that using estrogen plus progestin (E + P) HRT was associated with higher MD than estrogen alone. Four studies reported that continuous estrogen plus progestin (CEP) users had higher MD than sequential estrogen plus progestin (SEP) and estrogen alone users. However, two studies showed that SEP users had slightly higher MD than CEP users and estrogen alone users.
CONCLUSIONS
Epidemiological evidence is rather consistent suggesting that there is a positive association between HRT use and MD with the highest increase in MD among current users, and CEP users. Our results suggest that due to increase in MD and masking effect, current E + P users may require additional screening procedures, shorter screening intervals, or using advanced imaging techniques.
Topics: Breast Density; Breast Neoplasms; Female; Hormone Replacement Therapy; Humans; Risk Factors
PubMed: 32572713
DOI: 10.1007/s10549-020-05744-w -
Applied Physiology, Nutrition, and... Jul 2021Face masks are promoted for preventing spread of viruses; however, wearing a mask during exercise might increase CO rebreathing, decrease arterial oxygenation, and... (Meta-Analysis)
Meta-Analysis
Face masks are promoted for preventing spread of viruses; however, wearing a mask during exercise might increase CO rebreathing, decrease arterial oxygenation, and decrease exercise performance. A systematic review and meta-analysis was conducted on the impact of wearing a mask during exercise. Data sources included SPORTDiscus, PubMed, and Medline. Eligibility criteria included all study designs comparing surgical, N95, or cloth masks to a no mask condition during any type of exercise where exercise performance and/or physiological parameters were evaluated. Healthy and clinical participants were included. Mean differences (MD) or standardized mean differences (SMD) with 95% confidence intervals were calculated and pooled effects assessed. Twenty-two studies involving 1573 participants (620 females, 953 males) were included. Surgical, or N95 masks did not impact exercise performance (SMD -0.05 [-0.16, 0.07] and -0.16 [-0.54, 0.22], respectively) but increased ratings of perceived exertion (SMD 0.33 [0.09, 0.58] and 0.61 [0.23, 0.99]) and dyspnea (SMD 0.6 [0.3, 0.9] for all masks). End-tidal CO (MD 3.3 [1.0, 5.6] and 3.7 [3.0, 4.4] mm Hg), and heart rate (MD 2 [0,4] beats/min with N95 masks) slightly increased. Face masks can be worn during exercise with no influences on performance and minimal impacts on physiological variables. PROSPERO registration: CRD42020224988. Face masks can be worn during exercise with no impacts on performance and minimal impacts on physiological variables.
Topics: COVID-19; Carbon Dioxide; Exercise; Female; Heart Rate; Humans; Male; Masks; N95 Respirators; Physical Functional Performance; SARS-CoV-2
PubMed: 33901405
DOI: 10.1139/apnm-2021-0143 -
Autoimmunity Reviews Aug 2021In the past years, translational approaches have led to early-stage clinical trials assessing safety and efficacy of tolerance-inducing cell-based treatments in... (Meta-Analysis)
Meta-Analysis Review
Safety and immunological proof-of-concept following treatment with tolerance-inducing cell products in patients with autoimmune diseases or receiving organ transplantation: A systematic review and meta-analysis of clinical trials.
In the past years, translational approaches have led to early-stage clinical trials assessing safety and efficacy of tolerance-inducing cell-based treatments in patients. This review aims to determine if tolerance-inducing cell-based therapies, including dendritic cells, regulatory T cells and mesenchymal stem cells, are safe in adult patients who underwent organ transplantation or in those with autoimmune diseases, including multiple sclerosis, diabetes mellitus type 1, Crohn's disease and rheumatoid arthritis. Immunological and clinical outcomes were reviewed, to provide evidence for proof-of-concept and efficacy. To summarize the current knowledge, a systematic review and meta-analysis were conducted. A total of 8906 records were reviewed by 2 independent assessors and 48 records were included in the final quantitative analysis. The overall frequency of serious adverse events was low: 0.018 (95% CI: 0.006-0.051). Immunological outcomes could not be assessed quantitatively because of heterogeneity in outcome assessments and description as well as lack of individual data. Most randomized controlled studies were at a medium risk of bias due to open-label treatment without masking of assessors and/or patients to the intervention. In conclusion, tolerance-inducing cell-based therapies are safe. We advocate for harmonization of study protocols of trials investigating cell-based therapies, adverse event reporting and systematic inclusion of immunological outcome measures in clinical trials evaluating tolerance-inducingcell-basedtreatment. Registration: PROSPERO, registration number CRD42020170557.
Topics: Adult; Autoimmune Diseases; Crohn Disease; Humans; Immune Tolerance; Organ Transplantation
PubMed: 34119672
DOI: 10.1016/j.autrev.2021.102873 -
Journal of Tissue Viability Aug 2021Coronavirus disease 2019 (COVID-19) is causing a rapid and tragic health emergency worldwide. Because of the particularity of COVID-19, people are at a high risk of...
BACKGROUND
Coronavirus disease 2019 (COVID-19) is causing a rapid and tragic health emergency worldwide. Because of the particularity of COVID-19, people are at a high risk of pressure injuries during the prevention and treatment process of COVID-19.
OBJECTIVES
This systematic review aimed to summarize the pressure injuries caused by COVID-19 and the corresponding preventive measures and treatments.
METHODS
This systematic review was according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. PubMed, Web of science and CNKI (Chinese) were searched for studies on pressure injuries caused by COVID-19 published up to August 4, 2020. The quality of included studies was assessed by the Newcastle-Ottawa Quality Assessment Scale (NOS) and the CARE guidelines.
RESULTS
The data were extracted from 16 studies involving 7,696 participants in 7 countries. All studies were published in 2020. There are two main types of pressure injuries caused by the COVID-19: 1) Pressure injuries that caused by protective equipment (masks, goggles and face shield, etc.) in the prevention process; 2) pressure injuries caused by prolonged prone position in the therapy process.
CONCLUSIONS
In this systematic review, the included studies showed that wearing protective equipment for a long time and long-term prone positioning with mechanical ventilation will cause pressure injuries in the oppressed area. Foam dressing may need to be prioritized in the prevention of medical device related pressure injuries. The prevention of pressure injuries should be our particular attention in the course of clinical treatment and nursing.
Topics: COVID-19; Humans; Pandemics; Personal Protective Equipment; Pressure Ulcer; Respiration, Artificial; Risk Factors; SARS-CoV-2
PubMed: 33895045
DOI: 10.1016/j.jtv.2021.04.002 -
The Cochrane Database of Systematic... Jun 2022Glaucoma is a group of optic neuropathies characterized by progressive degeneration of the retinal ganglion cells, axonal loss and irreversible visual field defects.... (Review)
Review
BACKGROUND
Glaucoma is a group of optic neuropathies characterized by progressive degeneration of the retinal ganglion cells, axonal loss and irreversible visual field defects. Glaucoma is classified as primary or secondary, and worldwide, primary glaucoma is a leading cause of irreversible blindness. Several subtypes of glaucoma exist, and primary open-angle glaucoma (POAG) is the most common. The etiology of POAG is unknown, but current treatments aim to reduce intraocular pressure (IOP), thus preventing the onset and progression of the disease. Compared with traditional antiglaucomatous treatments, rho kinase inhibitors (ROKi) have a different pharmacodynamic. ROKi is the only current treatment that effectively lowers IOP by modulating the drainage of aqueous humor through the trabecular meshwork and Schlemm's canal. As ROKi are introduced into the market more widely, it is important to assess the efficacy and potential AEs of the treatment.
OBJECTIVES
To compare the efficacy and safety of ROKi with placebo or other glaucoma medication in people diagnosed with open-angle glaucoma (OAG), primary open-angle glaucoma (POAG) or ocular hypertension (OHT).
SEARCH METHODS
We used standard Cochrane methods and searched databases on 11 December 2020.
SELECTION CRITERIA
We included randomized clinical trials examining commercially available ROKi-based monotherapy or combination therapy compared with placebo or other IOP-lowering medical treatments in people diagnosed with (P)OAG or OHT. We included trials where ROKi were administered according to official glaucoma guidelines. There were no restrictions regarding type, year or status of the publication.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Two review authors independently screened studies, extracted data, and evaluated risk of bias by using Cochrane's RoB 2 tool. MAIN RESULTS: We included 17 trials with 4953 participants diagnosed with (P)OAG or OHT. Fifteen were multicenter trials and 15 were masked trials. All participants were aged above 18 years. Trial duration varied from 24 hours to 12 months. Trials were conducted in the USA, Canada and Japan. Sixteen trials were funded by pharmaceutical companies, and one trial provided no information about funding sources. The trials compared ROKi monotherapy (netarsudil or ripasudil) or combination therapy with latanoprost (prostaglandin analog) or timolol (beta-blocker) with placebo, timolol, latanoprost or netarsudil. Reported outcomes were IOP and safety. Meta-analyses were applied to 13 trials (IOP reduction from baseline) and 15 trials (ocular AEs). Of the trials evaluating IOP, seven were at low risk, three had some concerns, and three were at high risk of bias. Three trials found that netarsudil monotherapy may be superior to placebo (mean difference [MD] 3.11 mmHg, 95% confidence interval [CI] 2.59 to 3.62; I = 0%; 155 participants; low-certainty evidence). Evidence from three trials found that timolol may be superior to netarsudil with an MD of 0.66 mmHg (95% CI 0.41 to 0.91; I = 0%; 1415 participants; low-certainty evidence). Evidence from four trials found that latanoprost may be superior to netarsudil with an MD of 0.97 mmHg (95% CI 0.67 to 1.27; I = 4%; 1283 participants; moderate-certainty evidence). Evidence from three trials showed that, compared with monotherapy with latanoprost, combination therapy with netarsudil and latanoprost probably led to an additional pooled mean IOP reduction from baseline of 1.64 mmHg (95% CI -2.16 to -1.11; 1114 participants). Evidence from three trials showed that, compared with monotherapy with netarsudil, combination therapy with netarsudil and latanoprost probably led to an additional pooled mean IOP reduction from baseline of 2.66 mmHg (95% CI -2.98 to -2.35; 1132 participants). The certainty of evidence was moderate. One trial showed that, compared with timolol monotherapy, combination therapy with ripasudil and timolol may lead to an IOP reduction from baseline of 0.75 mmHg (95% -1.29 to -CI 0.21; 208 participants). The certainty of evidence was moderate. Of the trials assessing total ocular AEs, three were at low risk, four had some concerns, and eight were at high risk of bias. We found very low-certainty evidence that netarsudil may lead to more ocular AEs compared with placebo, with 66 more ocular AEs per 100 person-months (95% CI 28 to 103; I = 86%; 4 trials, 188 participants). We found low-certainty evidence that netarsudil may lead to more ocular AEs compared with latanoprost, with 29 more ocular AEs per 100 person-months (95% CI 17 to 42; I = 95%; 4 trials, 1286 participants). We found moderate-certainty evidence that, compared with timolol, netarsudil probably led to 21 additional ocular AEs (95% CI 14 to 27; I = 93%; 4 trials, 1678 participants). Data from three trials (1132 participants) showed no evidence of differences in the incidence rate of AEs between combination therapy with netarsudil and latanoprost and netarsudil monotherapy (1 more event per 100 person-months, 95% CI 0 to 3); however, the certainty of evidence was low. Similarly, we found low-certainty evidence that, compared with latanoprost, combination therapy with netarsudil and latanoprost may cause 29 more ocular events per 100 person-months (95% CI 11 to 47; 3 trials, 1116 participants). We found moderate-certainty evidence that, compared with timolol monotherapy, combination therapy with ripasudil and timolol probably causes 35 more ocular events per 100 person-months (95% CI 25 to 45; 1 trial, 208 participants). In all included trials, ROKi was reportedly not associated with any particular serious AEs.
AUTHORS' CONCLUSIONS
The current evidence suggests that in people diagnosed with OHT or (P)OAG, the hypotensive effect of netarsudil may be inferior to latanoprost and slightly inferior to timolol. Combining netarsudil and latanoprost probably further reduces IOP compared with monotherapy. Netarsudil as mono- or combination therapy may result in more ocular AEs. However, the certainty of evidence was very low or low for all comparisons except timolol. In general, AEs were described as mild, transient, and reversible upon treatment discontinuation. ROKi was not associated with any particular serious AEs. Future trials of sufficient size and follow-up should be conducted to provide reliable information about glaucoma progression, relevant IOP measurements and a detailed description of AEs using similar terminology. This would ensure the robustness and confidence of the results and assess the intermediate- and long-term efficacy and safety of ROKi.
Topics: Glaucoma, Open-Angle; Humans; Ocular Hypertension; Randomized Controlled Trials as Topic; Treatment Outcome; rho-Associated Kinases
PubMed: 35686679
DOI: 10.1002/14651858.CD013817.pub2 -
PLoS Medicine Sep 2020There is disagreement about the level of asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We conducted a living systematic review and... (Meta-Analysis)
Meta-Analysis
BACKGROUND
There is disagreement about the level of asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We conducted a living systematic review and meta-analysis to address three questions: (1) Amongst people who become infected with SARS-CoV-2, what proportion does not experience symptoms at all during their infection? (2) Amongst people with SARS-CoV-2 infection who are asymptomatic when diagnosed, what proportion will develop symptoms later? (3) What proportion of SARS-CoV-2 transmission is accounted for by people who are either asymptomatic throughout infection or presymptomatic?
METHODS AND FINDINGS
We searched PubMed, Embase, bioRxiv, and medRxiv using a database of SARS-CoV-2 literature that is updated daily, on 25 March 2020, 20 April 2020, and 10 June 2020. Studies of people with SARS-CoV-2 diagnosed by reverse transcriptase PCR (RT-PCR) that documented follow-up and symptom status at the beginning and end of follow-up or modelling studies were included. One reviewer extracted data and a second verified the extraction, with disagreement resolved by discussion or a third reviewer. Risk of bias in empirical studies was assessed with an adapted checklist for case series, and the relevance and credibility of modelling studies were assessed using a published checklist. We included a total of 94 studies. The overall estimate of the proportion of people who become infected with SARS-CoV-2 and remain asymptomatic throughout infection was 20% (95% confidence interval [CI] 17-25) with a prediction interval of 3%-67% in 79 studies that addressed this review question. There was some evidence that biases in the selection of participants influence the estimate. In seven studies of defined populations screened for SARS-CoV-2 and then followed, 31% (95% CI 26%-37%, prediction interval 24%-38%) remained asymptomatic. The proportion of people that is presymptomatic could not be summarised, owing to heterogeneity. The secondary attack rate was lower in contacts of people with asymptomatic infection than those with symptomatic infection (relative risk 0.35, 95% CI 0.10-1.27). Modelling studies fit to data found a higher proportion of all SARS-CoV-2 infections resulting from transmission from presymptomatic individuals than from asymptomatic individuals. Limitations of the review include that most included studies were not designed to estimate the proportion of asymptomatic SARS-CoV-2 infections and were at risk of selection biases; we did not consider the possible impact of false negative RT-PCR results, which would underestimate the proportion of asymptomatic infections; and the database does not include all sources.
CONCLUSIONS
The findings of this living systematic review suggest that most people who become infected with SARS-CoV-2 will not remain asymptomatic throughout the course of the infection. The contribution of presymptomatic and asymptomatic infections to overall SARS-CoV-2 transmission means that combination prevention measures, with enhanced hand hygiene, masks, testing tracing, and isolation strategies and social distancing, will continue to be needed.
Topics: Asymptomatic Diseases; Asymptomatic Infections; Betacoronavirus; COVID-19; Coronavirus Infections; Disease Progression; Humans; Mass Screening; Pandemics; Pneumonia, Viral; Reverse Transcriptase Polymerase Chain Reaction; SARS-CoV-2
PubMed: 32960881
DOI: 10.1371/journal.pmed.1003346 -
Biological Psychiatry Jan 2021Accumulating evidence suggests that the use of cannabis and nicotine and tobacco-related products (NTPs) during the adolescent years has harmful effects on the... (Review)
Review
Accumulating evidence suggests that the use of cannabis and nicotine and tobacco-related products (NTPs) during the adolescent years has harmful effects on the developing brain. Yet, few studies have focused on the developing brain as it relates to the co-administration of cannabis and NTPs, despite the high prevalence rates of co-use in adolescence. This review aims to synthesize the existing literature on neurocognitive, structural neuroimaging, and functional neuroimaging outcomes associated with cannabis and NTP co-use. A systematic search of peer-reviewed articles resulted in a pool of 1107 articles. Inclusion criteria were 1) data-based study; 2) age range of 13 to 35 years or, for preclinical studies, nonadult subjects; 3) cannabis and NTP group jointly considered; and 4) neurocognitive, structural neuroimaging, or functional neuroimaging as an outcome measure. Twelve studies met inclusion criteria. Consistent with the literature, cannabis and nicotine were found to have independent effects on cognition. The available research on the co-use of cannabis and NTPs demonstrates a potential nicotine-related masking effect on cognitive deficits associated with cannabis use, yet there is little research on co-use and associations with neuroimaging indices. In neuroimaging studies, there is preliminary evidence for hippocampal volume differences in co-users and a lack of evidence for co-use differences related to nucleus accumbens activity during reward processing. Notably, no structural neuroimaging studies were found to examine the combined effects of nicotine and cannabis in adolescent-only populations. Further research, including longitudinal studies, is warranted to investigate the influence of cannabis and NTP co-use on maturation.
Topics: Adolescent; Adult; Brain; Cannabis; Cognition; Humans; Neuroimaging; Nicotine; Young Adult
PubMed: 33334432
DOI: 10.1016/j.biopsych.2020.09.021 -
Addiction (Abingdon, England) Oct 2023Behavioural smoking cessation trials have used comparators that vary considerably between trials. Although some previous meta-analyses made attempts to account for... (Review)
Review
BACKGROUND AND AIMS
Behavioural smoking cessation trials have used comparators that vary considerably between trials. Although some previous meta-analyses made attempts to account for variability in comparators, these relied on subsets of trials and incomplete data on comparators. This study aimed to estimate the relative effectiveness of (individual) smoking cessation interventions while accounting for variability in comparators using comprehensive data on experimental and comparator interventions.
METHODS
A systematic review and meta-regression was conducted including 172 randomised controlled trials with at least 6 months follow-up and biochemically verified smoking cessation. Authors were contacted to obtain unpublished information. This information was coded in terms of active content and attributes of the study population and methods. Meta-regression was used to create a model predicting smoking cessation outcomes. This model was used to re-estimate intervention effects, as if all interventions have been evaluated against the same comparators. Outcome measures included log odds of smoking cessation for the meta-regression models and smoking cessation differences and ratios to compare relative effectiveness.
RESULTS
The meta-regression model predicted smoking cessation rates well (pseudo R = 0.44). Standardising the comparator had substantial impact on conclusions regarding the (relative) effectiveness of trials and types of intervention. Compared with a 'no support comparator', self-help was 1.33 times (95% CI = 1.16-1.49), brief physician advice 1.61 times (95% CI = 1.31-1.90), nurse individual counselling 1.76 times (95% CI = 1.62-1.90), psychologist individual counselling 2.04 times (95% CI = 1.95-2.15) and group psychologist interventions 2.06 times (95% CI = 1.92-2.20) more effective. Notably, more elaborate experimental interventions (e.g. psychologist counselling) were typically compared with more elaborate comparators, masking their effectiveness.
CONCLUSIONS
Comparator variability and underreporting of comparators obscures the interpretation, comparison and generalisability of behavioural smoking cessation trials. Comparator variability should, therefore, be taken into account when interpreting and synthesising evidence from trials. Otherwise, policymakers, practitioners and researchers may draw incorrect conclusions about the (cost) effectiveness of smoking cessation interventions and their constituent components.
Topics: Humans; Smoking Cessation; Behavior Therapy; Counseling; Cost-Effectiveness Analysis
PubMed: 37132077
DOI: 10.1111/add.16222 -
Frontiers in Immunology 2022More than a quarter of single-country systemic lupus erythematosus (SLE) interventional randomized clinical trials (RCTs) were conducted in China. To help develop...
OBJECTIVES
More than a quarter of single-country systemic lupus erythematosus (SLE) interventional randomized clinical trials (RCTs) were conducted in China. To help develop management guidelines and set benchmarks for future SLE research, a systematic review of current trials is needed.
METHODS
We searched systematically three databases and four registries to summarize the interventional RCTs in mainland China and identify factors associated with participant loss. The internal validity of trials was assessed using the Cochrane risk-of-bias tool for assessing risk of bias. The odds ratio (OR) was defined as the ratio of the odds of less than 10% loss to follow-up in the presence or absence of different factors.
RESULTS
A total of 188 trials met our inclusion criteria, and 15·5% of trials conducted in mainland China ranked low risk of bias. Participant loss was significantly higher among trials that had a defined primary outcome or were registered {primary outcome identification (0·02 [0·00-0·23]) and registration (0·14 [0·03-0·69])}. Trials examining traditional Chinese medicine (TCM) pharmacological treatments had an 8·16-fold (8·16 [1·28-51·98]) higher probability of having low participant loss than trials examining non-TCM pharmacological treatment trials, and trials that did not report masking status had a 15·95-fold (15·95 [2·45-103·88]) higher probability of having low participant loss than open-label trials. In addition, published articles in Chinese also had higher probability of having low participant loss (5·39 [1·10-26·37]).
CONCLUSION
SLE trials conducted in mainland China were of relatively poor quality. This situation, including nonrigorous design, lack of registration, and absence of compliance reporting, needs to be ameliorated. To maintain the fundamental repeatability and comparability of mainland China SLE RCTs, transparency of the clinical trial process and complete reporting of the trial data are crucial and urgently needed.
Topics: China; Humans; Lupus Erythematosus, Systemic; Medicine, Chinese Traditional; Publications; Research Design
PubMed: 35479089
DOI: 10.3389/fimmu.2022.848478