Tag: pubmed

BMJ Open. 2021 Jun 16;11(6):e043906. doi: 10.1136/bmjopen-2020-043906.

ABSTRACT

RATIONALE: Clinical trials are the gold standard for testing interventions. COVID-19 has further raised their public profile and emphasised the need to deliver better, faster, more efficient trials for patient benefit. Considerable overlap exists between data required for trials and data already collected routinely in electronic healthcare records (EHRs). Opportunities exist to use these in innovative ways to decrease duplication of effort and speed trial recruitment, conduct and follow-up.

APPROACH: The National Institute of Health Research (NIHR), Health Data Research UK and Clinical Practice Research Datalink co-organised a national workshop to accelerate the agenda for ‘data-enabled clinical trials’. Showcasing successful examples and imagining future possibilities, the plenary talks, panel discussions, group discussions and case studies covered: design/feasibility; recruitment; conduct/follow-up; collecting benefits/harms; and analysis/interpretation.

REFLECTION: Some notable studies have successfully accessed and used EHR to identify potential recruits, support randomised trials, deliver interventions and supplement/replace trial-specific follow-up. Some outcome measures are already reliably collected; others, like safety, need detailed work to meet regulatory reporting requirements. There is a clear need for system interoperability and a ‘route map’ to identify and access the necessary datasets. Researchers running regulatory-facing trials must carefully consider how data quality and integrity would be assessed. An experience-sharing forum could stimulate wider adoption of EHR-based methods in trial design and execution.

DISCUSSION: EHR offer opportunities to better plan clinical trials, assess patients and capture data more efficiently, reducing research waste and increasing focus on each trial’s specific challenges. The short-term emphasis should be on facilitating patient recruitment and for postmarketing authorisation trials where research-relevant outcome measures are readily collectable. Sharing of case studies is encouraged. The workshop directly informed NIHR’s funding call for ambitious data-enabled trials at scale. There is the opportunity for the UK to build upon existing data science capabilities to identify, recruit and monitor patients in trials at scale.

PMID:34135032 | DOI:10.1136/bmjopen-2020-043906

BMJ Open. 2021 Jun 16;11(6):e033935. doi: 10.1136/bmjopen-2019-033935.

ABSTRACT

OBJECTIVES: The aim of this study is to quantify societal preferences for, and assess trade-offs between characteristics of treatment programmes for impulsive-violent offenders.

SETTING: The study was conducted in New South Wales, Australia’s largest state.

PARTICIPANTS: The study participants were income tax payers, aged over 18 and who were able to provide informed consent.

METHODS: A discrete choice experiment was used to assess the preferences for treatment programmes for impulsive violent offenders. The survey presented participants with six choice sets in which they chose between two unlabelled treatment scenarios and a ‘no treatment’ choice. A random parameters logistic (RPL) model and a latent class (LC) model were used to analyse the societal preferences for treatment and estimate willingness to pay values based on marginal rates of substitution. Respondents were asked to self-identify if they ever had experiences with violence and subgroup analysis was done.

RESULTS: The survey was completed by 1021 highly engaged participants. The RPL model showed that society had a preference for more effective programmes, programmes that provided full as opposed to partial treatment of all co-occurring health conditions, compulsory over voluntary programmes, those with flexibility in appointments and programmes that are provided with continuity of care postprison. Respondents were willing to pay an additional annual tax contribution for all significant attributes, particularly compulsory programmes, continuity of treatment and effectiveness.The LC model identified two classes of respondents with some differences in preferences which could be largely identified by whether they had experiences with violence or not.

CONCLUSION: The results are important for future programme design and implementation. Programmes for impulsive violent offenders that are designed to encompass societal preferences are likely to be supported by public and tax payers.

PMID:34135027 | DOI:10.1136/bmjopen-2019-033935

Int J Clin Pract. 2021 Jun 16:e14539. doi: 10.1111/ijcp.14539. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: Breast cancer is one of the most common malignant tumors among women. In this study, we compared the analgesic efficacy of ultrasound (US)-guided rhomboid intercostal nerve block, erector spinae plane (ESP) block, and serratus plane block (SAB) after modified radical mastectomy (MRM) of unilateral breast cancer.

METHODS: This study involved a double-blind clinical trial that was carried out in the Affiliated Hospital of Jiaxing University on September 23, 2020. The inclusion criteria were the following: the American Society of Anesthesiologists (ASA) grade needed to be 1-2, the patients needed to be between 18 and 80 years old, and MRM needed to be proposed in our hospital. The exclusion criteria were patients with contraindications related to nerve block. Ninety patients were randomly divided into three groups receiving US-guided SAB, ESP block, and rhomboid intercostal block (RIB). All groups received 20 mL 0.5% ropivacaine. Within 24 hours after the operation, the patients received an intravenous injection of tramadol 1-2 mg/kg in the surgical ward for pain relief.

RESULTS: The dosage of tramadol 24 hours after the operation in the RIB (269.67 ± 48.75 mg) and ESP block groups (273.67 ± 36.90 mg) was significantly lower than that in the SAB group (314.33 ± 18.88 mg) (P < 0.001). There was no statistical difference in tramadol consumption between the ESP block and RIB groups within 24 hours (P = 0.676). The numerical rating scale (NRS) scores in the ESP block and RIB groups at 0.5, 1, 3, 6, 12, 18, and 24 hours after the operation once patients were active were significantly lower than that in the SAB group (P < 0.05 for all comparisons); however, the NRS scores of the RIB and ESP block groups did not differ significantly within 24 hours after surgery when patients were active.

CONCLUSIONS: US-guided rhomboid intercostal block (US-RIB) and ESP block can effectively reduce the dosage of tramadol within 24 hours after MRM, and they can effectively relieve pain within 24 hours after MRM compared with SAB.

PMID:34133831 | DOI:10.1111/ijcp.14539

BJU Int. 2021 Jun 16. doi: 10.1111/bju.15516. Online ahead of print.

ABSTRACT

OBJECTIVES: To investigate volume-outcome relationships in robot-assisted radical prostatectomy for cancer using data from the Hospital Episodes Statistics (HES) database for England.

MATERIALS AND METHODS: Data for all adult, elective radical prostatectomies for cancer during the period January 2013-December 2018 (inclusive) were extracted from the HES database. HES records data on all National Health Service hospital admissions in England. Data were extracted for the NHS trust and surgeon undertaking the procedure, the surgical technique used (laparoscopic, open or robot-assisted), length of hospital stay, emergency readmissions and deaths. Multilevel modelling was used to adjust for hierarchy and covariates.

RESULTS: Data were available for 35,629 radical prostatectomies (27,945 robot-assisted). The proportion of procedures conducted as robot-assisted surgery increased from 53.2% in 2013 to 92.6% in 2018. For robot-assisted surgery, there was a significant relationship between 90-day emergency hospital readmission (primary outcome) and trust volume (odds ratio for volume decrease of ten procedures 0.99 (95% confidence interval 0.99 to 1.00, p = 0.037) and surgeon volume (odds ratio for volume decrease of ten procedures 0.99 (95% confidence interval 0.99 to 1.00, p = 0.013) in the previous year. From lowest to highest volume category there was a decline in the adjusted proportion of patients readmitted as an emergency at 90 days from 10.6% (0-49 procedures) to 7.0% (≥ 300 procedures) for trusts and from 9.4% (0-9 procedures) to 8.3% (≥ 100 procedures) for surgeons. Length of stay was also significantly associated with surgeon and trust volume, although one year mortality was associated with neither.

CONCLUSIONS: There is evidence of a volume-outcome relationship for robot-assisted radical prostatectomy in England and minimising low volume surgery will improve patient outcomes. Nevertheless, the observed effect size was relatively modest, and stakeholders should be realistic when evaluating the likely impact of further centralisation at a population level.

PMID:34133832 | DOI:10.1111/bju.15516

Int J Paediatr Dent. 2021 Jun 16. doi: 10.1111/ipd.12851. Online ahead of print.

ABSTRACT

BACKGROUND: Implementing effective pain management is important to increase patient compliance in pediatric dental procedures.

AIM: This pilot study was conducted to evaluate the effectiveness of virtual reality (VR) on pain perception in dental procedures in children.

MATERIAL AND METHODS: 54 children aged between 5-12 years were included. Patients scheduled to receive dental procedures not requiring local anesthesia (e.g., fluoride therapy) were assigned to Group A, and patients scheduled to receive painful dental procedures requiring local anesthesia (e.g., pulp therapies, teeth extraction) were assigned to Group B. Patients in each group were randomly assigned and were equally likely to either receive VR during their dental procedure, or treatment as usual (without VR). Visual Analog Scale (VAS), Wong-Baker faces rating scale, and the ‘Face, Legs, Activity, Cry, Consolability’ scale (FLACC scale) were used to assess the pain levels during dental procedures.

RESULTS: Patients receiving painful dental procedures requiring local anesthesia reported significant reductions in pain intensity/worst pain during the dental procedure on all subjective and behavioral pain measures of pain intensity, (p<0.05 on each). Patients receiving non-painful dental procedures showed the predicted pattern but no significant reduction in worst pain during VR.

CONCLUSION: The use of VR was found to be an effective distraction tool to ease pain and anxiety in the tested dental procedures, for children receiving painful dental procedures.

PMID:34133809 | DOI:10.1111/ipd.12851

Acad Emerg Med. 2021 Jun 16. doi: 10.1111/acem.14312. Online ahead of print.

ABSTRACT

OBJECTIVES: To conduct an umbrella review of therapeutic studies relevant to emergency medicine, analyzing patterns in effect size, power and signals of potential bias across an entire field of clinical research.

METHODS: We combined topic and journal-driven searches of PUBMED and Google Scholar for published articles of systematic reviews and meta-analyses relevant to emergency medicine (last search in November 2020). Data were screened and extracted by 6 investigators. Redundant meta-analyses were removed. Whenever possible for each comparison we extracted one meta-analysis on mortality with the most events, and one meta-analysis on a non-mortality outcome with the most studies. From each meta-analysis we extracted all individual study effects; outcomes were converted to odds ratios and placed on a common scale where an odds ratio <1.0 represents a reduction in a harmful outcome with an experimental treatment versus control. Outcomes were analyzed at the level of individual studies and at the level of summary effects across meta-analyses.

RESULTS: 332 articles contained 431 eligible meta-analyses with a total of 3129 individual study outcomes; of these, 2593 (83%) were from randomized controlled trials. The median odds ratio across all studies was 0.70. Within each meta-analysis, the earliest study effect on average demonstrated larger benefit compared to the overall summary effect. Only 57 of 431 meta-analyses (13%) both favored the experimental intervention and did not show any signal of small study effects or excess significance, and of those only 12 had at least one study with 80% or higher power to detect an odds ratio of 0.70. Of these, no interventions significantly decreased mortality in well-powered trials. Although the power of studies increased somewhat over time, the majority of studies were underpowered.

CONCLUSIONS: Few interventions studied within systematic reviews and meta-analyses relevant to emergency medicine seem to have strong and unbiased evidence for improving outcomes. The field would benefit from more optimally powered trials.

PMID:34133813 | DOI:10.1111/acem.14312

Int J Cosmet Sci. 2021 Jun 16. doi: 10.1111/ics.12720. Online ahead of print.

ABSTRACT

INTRODUCTION: Evaluation of skin ageing is a non-standardised, subjective process, with typical measures relying coarse, qualitatively defined features. Reflectance confocal microscopy depth stacks contain indicators of both chrono- and photo-ageing. We hypothesise that an ageing scale could be constructed using machine learning and image analysis, creating a data driven quantification of skin ageing without human assessment.

METHODS: En-face sections of reflectance confocal microscopy depth stacks from the dorsal and volar forearm of 74 participants (36/18/20 training/testing/validation) were represented using a histogram of visual features learned using unsupervised clustering of small image patches. A logistic regression classifier was trained on these histograms to differentiate between stacks from 20-30 year old and 50-70 year old volunteers. The probabilistic output of the logistic regression was used as the fine grained ageing score for that stack in the testing set ranging from 0 to 1. Evaluation was performed in two ways: on the test set the AUC was collected for the binary classification problem as well as by statistical comparison of the scores for age and body-site groups. Final validation was performed by assessing the accuracy of the ageing score measurement on 20 depth stacks not used for training or evaluating the classifier.

RESULTS: The classifier effectively differentiated stacks from age groups with an test set AUC of 0.908. Mean scores were significantly different when comparing age groups (mean 0.70 vs. 0.44; t=-6.62, p=0.0000) and also when comparing stacks from dorsal and volar body sites (mean 0.64 vs. 0.53; t=3.12, p=0.0062). On the final validation set 17 out of 20 depth stacks were correctly labelled.

DISCUSSION: Despite being limited to only coarse training information in the form of example stacks from two age groups, the trained classifier was still able to effectively discriminate between younger and older skin. Curiously, despite being only trained with chronological age, there was still evidence for measurable differences in age scores due to sun exposure – with marked differences in scores on sun exposed dorsal sites of some volunteers compared to less sun exposed volar sites. These results suggest that fine-grained data driven quantification of skin ageing is achievable.

PMID:34133771 | DOI:10.1111/ics.12720

Acta Paediatr. 2021 Jun 16. doi: 10.1111/apa.15987. Online ahead of print.

ABSTRACT

AIM: Our aim was to evaluate upper GI pathology found endoscopically among children seen in a GI feeding clinic for persistent feeding problems compared with controls.

METHODS: Esophagogastroduodenoscopy biopsy results were examined among two cohorts of children. The first group included 86 children evaluated in a gastroenterology feeding clinic for pediatric feeding disorders. A comparison was made with an age-matched control group of 86 children referred for endoscopy for conditions other than disordered feeding.

RESULTS: In the feeding cohort, 57% had abnormal endoscopy biopsies. These included 30% with microscopic esophagitis and 15.1 % with eosinophilic esophagitis. Among the controls, 53% had abnormal biopsies, which included 26% with microscopic esophagitis and 8% with eosinophilic esophagitis. The statistical comparison between groups included p = 0.98 for microscopic esophagitis and p = 0.15 for eosinophilic esophagitis.

CONCLUSION: Results demonstrated similar prevalence of abnormal endoscopy biopsies and microscopic esophagitis in both groups. The incidence of eosinophilic esophagitis in the feeding group triples that of previous reports and nearly doubles controls. Our findings suggest pediatric feeding disorders which do not resolve, may warrant investigation by upper endoscopy.

PMID:34133806 | DOI:10.1111/apa.15987

Rev Bras Enferm. 2021 Jun 9;74(3):e20200732. doi: 10.1590/0034-7167-2020-0732. eCollection 2021.

ABSTRACT

OBJECTIVES: To analyze the abstracts that relate nursing to the Theory of Culture Care Diversity and Universality, published in the annals of the main national scientific events in the category, over a 12-year period.

METHODS: documental research carried out in the annals of the Brazilian Nursing Congress and the National Nursing Research Seminar. Data collection took place from July/2018 to June/2019 using a form. Data was analyzed using descriptive statistics and content analysis.

RESULTS: 99 studies were analyzed, and three categories emerged: Cultural diversity, emic perspective, and cultural context: possibilities for applying the theory; Incongruencies and peculiarities of the care sectors: limitations of the application of the theory; Knowledge production to improve care: implications for professional nursing practice.

FINAL CONSIDERATIONS: the investigated scientific production enabled the construction of knowledge of cultural aspects related to nursing care and showed similarities and variations in care practices.

PMID:34133681 | DOI:10.1590/0034-7167-2020-0732

Rev Assoc Med Bras (1992). 2021 Jun 9:S0104-42302021005002206. doi: 10.1590/1806-9282.67.01.20200487. Online ahead of print.

ABSTRACT

OBJECTIVE: We aimed to demonstrate the clinical utility of CHA2DS2-VASc and anticoagulation and risk factors in atrial fibrillation risk scores in the assessment of one year mortality in patients with abdominal aortic aneurysm.

METHODS: We designed a retrospective cohort study using data from Suleyman Demirel University Hospital for the diagnosis of abdominal aortic aneurysm. The study included 120 patients with abdominal aortic aneurysm who underwent aortic computed tomography. Patients were divided into two groups according to presence of abdominal aortic aneurysm and the development of mortality. Predictors of mortality were determined by multiple logistic regression analysis.

RESULTS: Multivariate regression analysis showed that CHA2DS2-VASc score, advanced age, female gender and elevated white blood cell counts were independent predictors of abdominal aortic aneurysm development while CHA2DS2-VASc score and elevated glucose levels were independent predictors of one year mortality in patients with abdominal aortic aneurysm. The concordance statistics for anticoagulation and risk factors in atrial fibrillation risk Score and CHA2DS2-VASc risk score respectively were 0.96 and 0.97 and could significantly predict one year mortality in patients with abdominal aortic aneurysm (p<0.001, and p<0.001, respectively).

CONCLUSIONS: CHA2DS2-VASc and anticoagulation and risk factors in atrial fibrillation risk scores are easily obtained in an emergency setting and can accurately predict one year mortality as a noninvasive follow-up in patients with abdominal aortic aneurysm. These simple scores could be used as a point of care decision aid to help the clinician in counseling patients presenting with abdominal aortic aneurysm and their families on treatment protocols.

PMID:34133696 | DOI:10.1590/1806-9282.67.01.20200487