To analyze, hierarchically, factors associated with hospital readmissions for acute coronary syndrome.
Hospital readmissions have risen, especially in patients with multiple comorbidities, which are most often chronic. The leading causes of hospital readmission include acute coronary syndrome, which is costly and often preventable. Determining clinical and non‐clinical variables that increase the chances of readmission is important to assess and evaluate patients hospitalized for coronary heart diseases.
A case‐control study whose dependent variable was hospital readmission for acute coronary syndrome.
The study included 277 inpatients, of whom 132 were in their first hospitalization and 145 had already been hospitalized for acute coronary syndrome. The independent variables for this hierarchical model were sociodemographic conditions, life habits, access to health services, and physical health measures. Data were obtained by interviews, anthropometric measurements, and patient records. Logistic regression analysis was performed using the stepwise technique, with Microsoft Excel and R version 3.2.3. The research was reported via the Reporting of Observational Studies in Epidemiology (STROBE).
In the final hierarchical logistic model, the following risk factors were associated with readmission for acute coronary syndrome: inadequate drug therapy adherence, stress, history of smoking for 30 years or more, and the lack of use of primary care health services.
Clinical and non‐clinical variables are related to hospital readmission for acute coronary syndrome and can increase the chance of readmission by up to six times.
The predictive model can be used to avoid readmission for acute coronary syndrome, and it represents an advance in the prediction of the occurrence of the outcome. This implies the need for a reorientation of the network for post‐discharge care in the first hospitalization for acute coronary syndrome.
Cold atmospheric plasma (CAP) is a group of various chemical active species, such as ozone and nitric oxide, generated by working gas. CAP was demonstrated to have an effect on tissue regeneration and wound healing. We conducted this study to evaluate the efficacy and safety of CAP as a novel therapy for diabetic wounds in vitro and in vivo. The plasma consists of ionised helium gas that is produced by a high‐voltage and high‐frequency power supply. Eight‐week‐old male db/db mice and C57BL mice were treated with helium gas (control group), 90s' CAP (low‐dose group), and 180s' CAP (high‐dose group). Mice were treated and observed for 2 weeks. Skin samples from around the wound and blood samples were collected. Our in vitro analysis included scratch wound‐healing assays by using human HaCaT immortalised human epidermal cells. After 14 days of treatment, CAP could obviously promote diabetic wound healing. Wound closure rates were significantly higher in the low‐dose group and high‐dose groups compared with the control group. Meanwhile, compared with the control group, the protein expression of IL‐6, tumour necrosis factor‐α, inducible nitric oxide synthase, and superoxide dismutase in two CAP groups significantly decreased, while the protein expression of vascular endothelial growth factor and transforming growth factor‐β in two CAP groups significantly increased (all P < .05); these data show good agreement with the change in mRNA level (all P < .05). In vitro, scratch wound‐healing assays showed that plasma treatment could effectively ensure healing within 3 minutes of exposure (all P < .05). In addition, no difference was found in histological observations of normal skin and the level of serum alanine transaminase, aspartate aminotransferase, blood urea nitrogen, creatinine, and white blood cells among the CAP groups and control group. CAP treatment for 3 minutes every day improves wound healing in diabetic mice by suppressing inflammation, reducing oxidative stress, and enhancing angiogenesis, involving several proteins signalling, and it is safe for the liver and kidney.
The aim of this study is to evaluate the clinical and economic burden of wound care in the Tropics via a 5‐year institutional population health review. Within our data analysis, wounds are broadly classified into neuro‐ischaemic ulcers (NIUs), venous leg ulcers (VLUs), pressure injuries (PIs), and surgical site infections (SSIs). Between 2013 and 2017, there were a total of 56 583 wound‐related inpatient admissions for 41 461 patients, with a 95.1% increase in wound episodes per 1000 inpatient admissions over this period (142 and 277 wound episodes per 1000 inpatient admissions in 2013 and 2017, respectively). In 2017, the average length of stay for each wound episode was 17.7 days, which was 2.4 times that of an average acute admission at our institution. The average gross charge per wound episode was USD $12 967. Among the 12 218 patients with 16 674 wound episodes in 2017, 71.5% were more than 65 years of age with an average Charlson Comorbidity Index (CCI) of 7.2. Half (51.9%) were moderately or severely frail, while 41.3% had two or more wound‐related admission episodes. In 2017, within our healthcare cluster, the gross healthcare costs for all inpatient wound episodes stand at USD $216 million within hospital care and USD $596 000 within primary care. Most NIU patients (97.2%) had diabetes and they had the most comorbidities (average CCI 8.4) and were the frailest group of patients (44.9% severely frail). The majority of the VLU disease burden was at the specialist outpatient setting, with the average 1‐year VLU recurrence rate at 52.5% and median time between healing and recurrence at 9.5 months. PI patients were the oldest (86.5% more than 65 years‐old), constituted the largest cohort of patients with 3874 patients at an incidence of 64.6 per 1000 admissions in 2017, and have a 1‐year all‐cause mortality rate of 14.3%. For SSI patients, there was a 125% increase of 14.2 SSI wound episodes per 1000 inpatient admissions in 2013 to 32.0 in 2017, and a 413% increase in wound‐related 30‐day re‐admissions, from 40 in 2013 (4.1% of all surgeries) to 205 (8.3% of all surgeries) in 2017. The estimated gross healthcare cost per patient ranges from USD $15789–17 761 across the wound categories. Similar to global data, there is a significant and rising trend in the clinical and economic burden of wound care in Tropics.
Benefits of a transtheoretical model‐based exercise program on exercise adherence (primary outcome) and secondary outcomes (self‐efficacy, decisional balance, knee osteoarthritis symptoms and physical function) were assessed among older adults with knee osteoarthritis.
A two‐arm, superiority, assessor‐blinded, cluster randomized trial with randomization at the community level.
Participants were recruited from 14 communities in Beijing between April and October 2018 (N = 189). The intervention was a 24‐week transtheoretical model‐based exercise program and the control group underwent a non‐theory‐based exercise program. Exercise adherence was collected every four weeks and secondary outcomes were measured at baseline, 12 and 24 weeks. An independent t‐test and repeated measures ANOVA were the main statistical tests.
Most participants were women (92.5%), married (81.4%), with high‐school education (36.0%), with both knees affected (50.3%) and did not make use of a walker (93.8%). There were no significant differences between groups in any of the outcome measures at baseline. Repeated measures ANOVA indicated that there was a significant difference in the trend of adherence scores between the two groups from 0 to 24 weeks. The independent t‐test showed that scores in the intervention group were significantly better than in the control group at 16 weeks, 20 weeks and 24 weeks. Improvements in the intervention group were also significantly greater in all secondary outcomes than in the control group.
A theory‐based exercise program could improve exercise adherence, self‐efficacy, decisional balance, knee osteoarthritis symptoms and physical functioning in older adults with knee osteoarthritis.
The 24‐week theory‐based exercise program could improve exercise adherence, self‐efficacy, decisional balance, symptoms of knee osteoarthritis and physical functioning in older adults with knee osteoarthritis. The theory‐based exercise program could help older adults with knee osteoarthritis to improve their symptoms and knee function.
On 20th January 2020, the first COVID‐19 case was reported in Shanghai, China. As of 12th March 2020, 344 cases with laboratory‐confirmed COVID‐19 infection have been detected in Shanghai, of which three died, 321 patients are discharged, 20 patients still receive ongoing treatments (Shanghai Municipal Health Commission, 2020).
by Shuangshuang Li, Xudong Feng, Guodong Cao, Qianhui Wang, Ling WangObjectives
To investigate the association between inflammatory indices and clinical outcomes of hepatocellular carcinoma (HCC) patients treated with transarterial chemoembolization (TACE) by performing meta-analysis.Methods
A systematic literature search for relevant studies published up to August 2019 was performed by using PubMed, Web of Science, EMBASE, China National Knowledge Internet (CNKI) and Wanfang databases. Pooled hazard ratios (HR) or odds ratio (OR) and 95% confidence intervals (95% CI) were calculated.Results
A total of 5280 patients from 22 studies were finally enrolled in the meta-analysis. The results demonstrated that elevated preoperative NLR, PLR, and CRP was associated with poor OS in HCC patients treated by TACE (HR = 1.81, P3 cm (OR = 2.42, P = 0.005).Conclusions
Elevated preoperative NLR, PLR, and CRP are associated with poor prognosis in HCC patients treated with TACE. These inflammatory indices may be convenient, accessible, affordable and dependable biomarkers with prognostic potential for HCC patients treated by TACE.
by Marina Gil-Calvo, Irene Jimenez-Perez, Jose Ignacio Priego-Quesada, Ángel G. Lucas-Cuevas, Pedro Pérez-SorianoFoot orthoses are one of the most used strategies by healthy runners in injury prevention and performance improvement. However, their effect on running kinematics throughout an intense prolonged run in this population is unknown. Moreover, there is some controversy regarding the use of custom-made versus prefabricated foot orthoses. This study analysed the effect of different foot orthoses (custom-made, prefabricated and a control condition) on spatio-temporal and angular (knee flexion and foot eversion) kinematic parameters and their behaviour during an intense prolonged run. Twenty-four recreational runners performed three similar tests that consisted of running 20 min on a treadmill at 80% of their maximal aerobic speed, each one with a different foot orthosis condition. Contact and flight time, and stride length and stride rate were measured every 5 min by an optical measurement photoelectric cell system. Knee flexion and foot eversion kinematic parameters were measured by two high-speed cameras. No significant differences were found between the different foot orthoses in any of the time points studied and between the interaction of foot orthosis and behaviour over time, in any of the variables studied (P > 0.05). The use of custom-made and prefabricated foot orthoses during an intense prolonged run does not produce changes in spatio-temporal and kinematic parameters in healthy runners. These results suggest that a healthy runner maintains its ideal movement pattern throughout a 20 minute prolonged run, regardless the type of foot orthosis used.
To examine the relationships between perceived ethical leadership, perceived interactional justice climate and patient‐oriented organizational citizenship behavior.
A cross‐sectional non‐experimental design was employed.
The convenience sampling was adopted. Data were collected in July and August, 2018. A total of 738 nurses were recruited from eight Chinese hospitals. The survey included instrument scales of ethical leadership, interactional justice climate and patient‐oriented organizational citizenship behavior. SPSS version 22 was used to compute means, standard deviations and intercorrelations. The partial least squares structural equation modeling was chosen to estimate the path coefficients of the relationships.
Relationships among perceived ethical leadership, perceived interactional justice climate and organizational citizenship behaviors were statistically significant. Perceived interactional justice climate mediated the relationship between perceived ethical leadership and nurses’ organizational citizenship behaviors.
Ethical leadership is related to interactional justice climate, which in turn, increases nurses’ organizational citizenship behavior. Nurse leaders are encouraged to exhibit ethical behaviors and to create justice climate. Ethical leadership scale can be used to select, train and evaluate the nurse supervisors and managers.
Hospital administrators are encouraged to recruit and promote those with both moral compass and leadership potential to nursing leadership positions. Nursing managers should create a justice climate in their hospitals. Hospital administrators could use ethical leadership scale to develop ethical leadership training programs.
Most patient-reported outcome measures (PROM) for chronic wounds are specific to a single wound type (eg, pressure ulcer) or part of the body. A barrier to outcome assessment in wound care and research is the lack of a rigorously designed PROM that can be used across wound types and locations. This mixed method study describes the protocol for an international collaboration to develop and validate a new PROM called the WOUND-Q for adults with chronic wounds.
In phase I, the qualitative approach of interpretive description is used to elicit concepts important to people with wounds regarding outcome. Participants from Canada, Denmark, the Netherlands, and the USA are aged 18 years and older and have a wound that has lasted 3 months or longer. Interviews are digitally recorded, transcribed and coded. A conceptual framework and preliminary item pool are developed from the qualitative dataset. Draft scales are formed to cover important themes in the conceptual framework. These scales are refined using feedback from people with chronic wounds and wound care experts. After refinement, the scales are translated into Danish and Dutch, following rigorous methods, to prepare for an international field-test study. In phase II, data are collected in Canada, Denmark, the Netherlands, and the USA. An international sample of people with a large variety of chronic wounds complete the WOUND-Q. Rasch Measurement Theory analysis is used to identify the best subset of items to retain for each scale and to examine reliability and validity.
This study is coordinated at Brigham and Women’s Hospital (Boston, USA). Ethics board approval was received at each participating site for both study phases. Findings will be published in peer-reviewed journals and presented at national and international conferences and meetings.
We aimed to examine relationship between hours lying down per day, as a proxy for sedentary behaviour and risk of diabetes in young and middle-aged adults, and to assess if leisure-time physical activity and body mass index (BMI) modified this relationship.
A population-based prospective cohort study.
The cohort included 17 058 diabetes-free adults, at an age of 20–55 years in 1995–1997, who were followed-up to 2006–2008.
Incident diabetes was defined by self-report of diabetes or non-fasting glucose levels greater than 11 mmol/L at the follow-up.
Multivariable logistic regression models were used to obtain OR with 95% CI for risk of diabetes by the categories of hours lying down (≤7, 8 and ≥9 hours/day).
362 individuals (2.1%) developed diabetes during an average of 11-year follow-up. Individuals who reported lying down ≥9 hours/day had an adjusted OR of 1.35 (95% CI 1.01 to 1.80) for incident diabetes compared with those lying down 8 hours/day. Lying down ≤7 hours/day was not associated with the risk of diabetes. In analysis stratified by physical activity, the ORs associated with lying down ≥9 hours/day were 1.41 (95% CI 1.05 to 1.90) and 0.90 (95% CI 0.23 to 3.55), respectively, among the less active and highly active individuals (pinteraction=0.048). There was little evidence that the association differed by BMI status (pinteraction=0.62).
Prolonged hours lying down per day was associated with an increased risk of diabetes in young and middle-aged adults. The positive association appeared to be modified by physical activity but not by BMI.
In April 2019, 14 children were diagnosed with HIV infection by a private healthcare provider in Larkana district, Sindh province, Pakistan. Over the next 3 months, 930 individuals were diagnosed with HIV, >80% below 16 years, the largest ever outbreak of HIV in children in Pakistan. In this protocol paper, we describe research methods for assessing likely modes of HIV transmission in this outbreak and investigate spatial and molecular epidemiology.
A matched case–control study will be conducted with 406 cases recruited. Cases will be children aged below 16 years registered for care at the HIV treatment centre at Shaikh Zayed Children Hospital in Larkana City. Controls will be children who are HIV-uninfected (confirmed by a rapid HIV test) matched 1:1 by age (within 1 year), sex and neighbourhood. Following written informed consent from the guardian, a structured questionnaire will be administered to collect data on sociodemographic indices and exposure to risk factors for parenteral, vertical and sexual (only among those aged above 10 years) HIV transmission. A blood sample will be collected for hepatitis B and C serology (cases and controls) and HIV lineage studies (cases only). Mothers of participants will be tested for HIV to investigate the possibility of mother-to-child transmission. Conditional logistic regression will be used to investigate the association of a priori defined risk factors with HIV infection. Phylogenetic analyses will be conducted. Global positioning system coordinates of participants’ addresses will be collected to investigate concordance between the genetic and spatial epidemiology.
Ethical approval was granted by the Ethics Review Committee of the Aga Khan University, Karachi. Study results will be shared with Sindh and National AIDS Control Programs, relevant governmental and non-governmental organisations, presented at national and international research conferences and published in international peer-reviewed scientific journals.
The prevalence of haemorrhoidal diseases was high in general population, and many treatments are proposed for the management of haemorrhoids. The treatments include conservative and surgical interventions; the credibility and strength of current evidence of their effectiveness are not comprehensively evaluated. We aim to evaluate the credibility of systematic reviews and meta-analyses that assess the effectiveness of the treatments for haemorrhoidal diseases through an umbrella review.
We will search Ovid Medline, Embase, Cochrane library and Web of Science from inception to March 2020 without any language restriction. We will include meta-analyses that examine the effectiveness of treatments in the management of haemorrhoids. Two reviewers will independently screen the titles and abstracts of retrieved articles, and they will extract data from the included meta-analyses. For each meta-analysis, we will estimate the effect size of a treatment through the random-effect model and the fixed-effect model, and we will evaluate between-study heterogeneity (Cochrane’s Q and I2 statistics) and small-study effect (Egger’s test); we will also estimate the evidence of excess significance bias. Evidence of each treatment will be graded according to prespecified criteria. Methodological quality of each meta-analysis will be evaluated by using Assessment of Multiple Systematic Reviews 2. The corrected cover area method will be used to assess the impact of overlap in reviews on the findings of the umbrella review.
We will present the results of the umbrella review at conferences and publish the final report in a peer-reviewed journal. The umbrella review does not require ethical approval.
The purpose of this study is to investigate the effect of peer support on patient anxiety during the perioperative period of coronary angiography or percutaneous coronary intervention (PCI).
We will search the following databases (PubMed, Web of Science, EMBASE, Cochrane Library, CINAHL, Clinicaltrials.gov, WHO International Clinical Trials Registry Platform, Google Scholar, Chinese National Knowledge Infrastructure, Chinese Science and Technology Periodicals Database, Chinese BioMedical Database and Wanfang Data) from the date of database inception to January 2019. Only randomised controlled trials will be included. For the data analysis, we will use RevMan V.5.3.5 software to evaluate the risk of bias, and the heterogeneity will be investigated using the Q statistic and P index. Additionally, the Grading of Recommendations Assessment, Development and Evaluation system will be used to assess the quality of evidence.
No ethics approval will be required since this is a systematic review of published studies. We aim to report information regarding the effects of peer support on patient anxiety during the perioperative period of coronary angiography or PCI. This systematic review and meta-analysis will be submitted to a peer-reviewed journal for publication.
Internet search engine data have been widely used to monitor and predict infectious diseases. Existing studies have found correlations between search data and HIV/AIDS epidemics. We aimed to extend the literature through exploring the feasibility of using search data to monitor and predict the number of newly diagnosed cases of HIV/AIDS, syphilis and gonorrhoea in China.
This paper used vector autoregressive model to combine the number of newly diagnosed cases with Baidu search index to predict monthly newly diagnosed cases of HIV/AIDS, syphilis and gonorrhoea in China. The procedures included: (1) keywords selection and filtering; (2) construction of composite search index; (3) modelling with training data from January 2011 to October 2016 and calculating the prediction performance with validation data from November 2016 to October 2017.
The analysis showed that there was a close correlation between the monthly number of newly diagnosed cases and the composite search index (the Spearman’s rank correlation coefficients were 0.777 for HIV/AIDS, 0.590 for syphilis and 0.633 for gonorrhoea, p2 were all more than 85% and the mean absolute percentage errors were less than 11%, showing the good fitting effect and prediction performance of vector autoregressive model in this field.
Our study indicated the potential feasibility of using Baidu search data to monitor and predict the number of newly diagnosed cases of HIV/AIDS, syphilis and gonorrhoea in China.
Lung cancer is increasingly recognised as a heterogeneous disease. Recent advances with targeted therapies for lung cancer with oncogenic mutations have greatly improved the prognosis for this subset of patients, yet little is known about their experiences. This study aimed to identify the needs and explore the healthcare experiences of these advanced patients with oncogenic mutation driven lung cancer.
Qualitative interviews with patients with advanced or metastatic non-small cell lung cancer with oncogenic alterations in anaplastic lymphoma kinase, epidermal growth factor receptor or c-ros oncogene 1.
Patients were recruited from online lung cancer support groups within the USA. Interviews were conducted remotely or in person, transcribed verbatim and analysed using an iterative inductive and deductive process.
We included 39 patients (11 males and 28 females) with a median age of 48.
Two primary theme categories emerged: patients' unmet needs and improving healthcare experiences. Unmet needs are related to patients’ desire to view their disease as a chronic illness, aspire to live a meaningful existence without financial devastation, desire for understanding along with emotional support and needing help with practical matters. Improving healthcare experiences involved patients’ desire to trust the expertise of clinical providers, receive reliable care and be treated holistically and as informed partners.
Patients with lung cancer with oncogenic mutations live uncharted experiences. Targeted therapy brings hope, but uncertainty is daunting. Patients grapple with the meaning and purpose of their lives while day-to-day obligations remain challenging. Healthcare teams are instrumental in their care experiences, and patients desire providers who are up-to-date on advances in the field and treat them as whole persons.
The detailed associations between type 2 diabetes (T2D) and total stroke and magnesium intake as well as the dose–response trend should be updated in a timely manner.
Systematic review and meta-analyses.
PubMed, Embase, Cochrane Library, Web of Science and ClinicalTrials.gov were rigorously searched from inception to 15 March 2019.
Prospective cohort studies investigating these two diseases were included.
Relative risk (RR) and 95% CI in random effects models as well as absolute risk (AR) were pooled to calculate the risk of T2D and stroke. Methodological quality was assessed by the Newcastle-Ottawa Scale.
Forty-one studies involving 53 cohorts were included. The magnitude of the risk was significantly reduced by 22% for T2D (RR 0.78 (95% CI 0.75 to 0.81); p2 body mass index and those with ≥12-year follow-up; the reduced risk in Asians was not as notable as that in North American and European populations.
Magnesium intake has significantly inverse associations with T2D and total stroke in a dose-dependent manner. Feasible magnesium-rich dietary patterns may be highly beneficial for specific populations and could be highlighted in the primary T2D and total stroke prevention strategies disseminated to the public.
Chronic conditions require long periods of care and often involve repeated interactions with multiple healthcare providers. Faced with increasing illness burden and costs, healthcare systems are currently working towards integrated care to streamline these interactions and improve efficiency. To support this, one promising resource is the information on routine care delivery stored in various electronic healthcare databases (EHD). In chronic conditions, care delivery pathways (CDPs) can be constructed by linking multiple data sources and extracting time-stamped healthcare utilisation events and other medical data related to individual or groups of patients over specific time periods; CDPs may provide insights into current practice and ways of improving it. Several methods have been proposed in recent years to quantify and visualise CDPs. We present the protocol for a systematic review aiming to describe the content and development of CDP methods, to derive common recommendations for CDP construction.
This protocol followed the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols. A literature search will be performed in PubMed (MEDLINE), Scopus, IEEE, CINAHL and EMBASE, without date restrictions, to review published papers reporting data-driven chronic CDPs quantification and visualisation methods. We will describe them using several characteristics relevant for EHD use in long-term care, grouped into three domains: (1) clinical (what clinical information does the method use and how was it considered relevant?), (2) data science (what are the method’s development and implementation characteristics?) and (3) behavioural (which behaviours and interactions does the method aim to promote among users and how?). Data extraction will be performed via deductive content analysis using previously defined characteristics and accompanied by an inductive analysis to identify and code additional relevant features. Results will be presented in descriptive format and used to compare current CDPs and generate recommendations for future CDP development initiatives.
Database searches will be initiated in May 2019. The review is expected to be completed by February 2020. Ethical approval is not required for this review. Results will be disseminated in peer-reviewed journals and conference presentations.
To integrate intrinsic surgical risk into the paediatric preoperative risk prediction score (PRPS) model to construct a more comprehensive risk scoring system (modified PRPS) and improve the prediction accuracy of postoperative intensive care unit (ICU) admission in paediatric patients.
This was a retrospective study conducted between 1 January and 30 December 2016. Data on age, American Society of Anaesthesiology physical status (ASA-PS), oxygen saturation, prematurity, non-fasted status, severity of surgery and immediate transfer to the ICU after surgery were collected. The modified PRPS was developed by logistic regression in the derivation cohort; it was tested and compared with the paediatric PRPS and ASA-PS by the Hosmer-Lemeshow test, the receiver operating characteristic (ROC) curve and Kappa analysis in the validation cohort.
Hospital-based study in China.
Paediatric patients (≤14 years) who underwent surgery under general anaesthesia were included, and those who needed reoperation due to surgical complications or stayed in the ICU preoperatively were excluded.
ICU admission rate, defined as any patients’ direct disposition from the operating room to the ICU immediately after the surgery.
A total of 9261 paediatric patients were included in this study, with 418 patients admitted to the ICU. In the validation cohort, the modified PRPS model fit the test data well (deciles of risk goodness-of-fit 2=6.84, p=0.077). The area under the ROC curve of the modified PRPS, paediatric PRPS and ASA-PS were 0.963, 0.941 and 0.870, respectively (p
The modified PRPS integrating intrinsic surgical risk shows better prediction accuracy than the previous PRPS.
Orthopaedic injuries affect almost 90% of trauma patients. A previous scoping review and expert consultation survey identified 15 potential low-value intra-hospital practices in the adult orthopaedic trauma population. Limiting the frequency of such practices could reduce adverse events, improve clinical outcomes and free up resources. The aim of this study is to synthesise the evidence on intra-hospital practices for orthopaedic injuries, previously identified as potentially of low value.
We will search Medline, Excerpta Medica Database (EMBASE), the Cochrane Central Register of Controlled Trials and Epistemonikos to identify systematic reviews, randomised controlled trials (RCTs), quasi-RCTs, cohort studies and case–control studies that evaluate selected practices according to a priori PICOS statements (Population–Intervention–Comparator–Outcome–Study design) . We will evaluate the methodological quality for systematic reviews using the Measurement Tool to Assess Systematic Reviews version 2 (AMSTAR-2). Risk of bias in original studies will be evaluated with the Cochrane revised tool for RCTs (RoB2) and with the risk of bias in non-randomised studies of interventions (ROBINS-I) tool. If for a given practice, more than two original studies on our primary outcome are identified, we will conduct meta-analysis using a random effects model and assess heterogeneity using the I2 index. We will assess credibility of evidence (I–IV) based on statistical significance, sample size, heterogeneity and bias as per published criteria.
Ethics approval is not required as original data will not be collected. Knowledge users from three level I trauma centres are involved in the design and conduct of the study in accordance with an integrated knowledge translation approach. Findings related to the rapid review will be available in May 2020. They will be presented to key stakeholders to inform discussions and raise awareness on low-value injury care. In addition, results will be disseminated in a peer-reviewed journal, at national and international scientific meetings and to healthcare associations.
Mild obstructive sleep-disordered breathing (oSDB), characterised by habitual snoring without frequent apnoeas and hypopnoeas on polysomnography, is prevalent in children and commonly treated with adenotonsillectomy (AT). However, the absence of high-level evidence addressing the role of AT in improving health and behavioural outcomes has contributed to significant geographical variations in care and potential for surgery to be both overused and underused.
The Pediatric Adenotonsillectomy Trial for Snoring (PATS) is a single-blinded, multicentre randomised controlled trial designed to evaluate the effect of AT in treating mild oSDB. Four hundred sixty eligible children, aged 3.0–12.9 years old, will be randomised to either early adenotonsillectomy or to watchful waiting with supportive care (WWSC) with a 1:1 ratio. The study’s coprimary endpoints are (1) change from baseline in executive behaviour relating to self-regulation and organisation skills as measured by the Behavioural Rating Inventory of Executive Function (BRIEF) Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d-prime). A mixed effects model will be used to compare changes in the BRIEF GEC score and GNG score at 6 and 12 months from baseline between the AT arm and the WWSC arm.
The study protocol was approved by the institutional review board (IRB) at Children’s Hospital of Philadelphia (CHOP) on 3 October 2014 (14–0 11 214). The approval of CHOP as the central IRB of record was granted on 29 February 2016. The results will be published in peer-reviewed journals and presented at academic conferences. The data collected from the PATS study will be deposited in a repository (National Sleep Research Resource, sleepdata.org) after completion of the study to maximise use by the scientific community.