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1.
Eye (Lond) ; 2022 Nov 11.
Artigo em Inglês | MEDLINE | ID: mdl-36369263

RESUMO

This systematic review and meta-analysis investigated the impact of anti-vascular endothelial growth factor (VEGF) treatment in management of eyes with non-proliferative diabetic retinopathy (NPDR) without centre involving diabetic macular oedema (CI-DMO). We searched multiple databases for all randomised clinical trials (RCTs) that evaluated anti-VEGF treatment versus observation in eyes with NPDR without CI-DMO. Data was collected for six outcomes (best corrected visual acuity (BCVA) improvement, diabetic retinopathy severity score (DRSS), central subfield thickness, progression to vision threatening complications (VTCs), ocular adverse events and quality of life measures). Risk of bias was assessed using Cochrane risk-of-bias tool for randomised trials (RoB 2) and certainty of evidence was assessed using Grade of Recommendations, Assessment, Development and Evaluation (GRADE). We identified a total of 2 unique RCTs that compared aflibercept and sham to treat a total of 811 eyes. For BCVA change, there was a small, clinically insignificant benefit for aflibercept treatment at year 2 (MD 0.70, 95% CI 0.02-1.38, GRADE rating: MODERATE). DRSS demonstrated a statistically significant improvement with aflibercept use at year 2 (RR 3.76, 95% CI 2.75-5.13, GRADE rating: MODERATE). VTCs were significantly less in aflibercept arm at year 2 (RR 0.30, 95% CI 0.23-0.40, GRADE rating: MODERATE). In conclusion, aflibercept treatment versus observation in eyes with NPDR without CI-DMO can result in reduced risk of development of VTCs and regression of DRSS score over 2 years. Future trials are needed to increase the precision of the treatment effect and to provide data on quality-of-life metrics.PROSPERO Registration: CRD42021288608.

2.
S Afr J Commun Disord ; 69(1): e1-e13, 2022 Oct 28.
Artigo em Inglês | MEDLINE | ID: mdl-36331219

RESUMO

BACKGROUND:  Early classroom communication supports are critical in influencing oral language development and emergent literacy skills. It is both support from peers and adults, as well as the environment that impacts the quality and efficacy of language learning. Schools in particular play a key role in communication development, which will be further explored in this article. OBJECTIVES:  To describe how communication was being supported in the classroom by teachers in the areas of language-learning environment (LLE), language-learning interactions (LLIs) and language-learning opportunities (LLOs) to focus on classroom communication supports to strengthen literacy outcomes for Grade R learners. METHOD:  A cross-sectional descriptive survey of classrooms was conducted using a structured observation method in 136 classrooms. The Communication Supporting Classroom Observation Tool was used to make 223 observations across classrooms of LLE (19 items), LLI (20 items) and LLO (5 items). A descriptive analysis of frequency of occurrence of items was conducted for each domain. RESULTS:  Language-learning environment had more frequently occurring observations, with 12 out of 19 items being observed with a frequency of occurrence greater than 65%, indicating that the environment had adequate basic resources (e.g. good light). Language-learning interactions scores indicated that 3 out of 20 items were observed frequently, while 17 out of 20 items were observed less frequently (56.5%), including interactive strategies (e.g. turn-taking). Language Learning Opportunities scores indicated that teacher-led behaviours (e.g. including children in small group activities) were infrequently observed on all items. CONCLUSION:  While the physical environment was generally supportive, the behaviours in the interactive domains of LLI and LLO were observed less frequently. There is potential for speech-language therapists to work collaboratively with teachers to develop communication supporting classrooms as a critical primary-level intervention for language-literacy learning.


Assuntos
Linguagem Infantil , Alfabetização , Instituições Acadêmicas , Aprendizagem Verbal , Adulto , Criança , Humanos , Estudos Transversais , África do Sul , Inquéritos e Questionários , Comunicação , Ensino , Aprendizagem , Desenvolvimento Infantil
3.
BMJ Open ; 12(11): e062360, 2022 Nov 17.
Artigo em Inglês | MEDLINE | ID: mdl-36396301

RESUMO

INTRODUCTION: Evidence-based recommendations for paediatric community-acquired pneumonia (CAP) diagnosis and management are needed. Uncomplicated CAP is often caused by respiratory viruses, especially in younger children; these episodes self-resolve without antibiotic treatment. Unfortunately, there are no clinical criteria that reliably discriminate between viral and bacterial disease, and so the majority of children diagnosed with CAP are given antibiotics-even though these will often not help and may cause harm. We have developed a novel care pathway that incorporates point-of-care biomarkers, radiographic patterns, microbiological testing and targeted follow-up. The primary study objective is to determine if the care pathway will be associated with less antimicrobial prescribing. METHODS AND ANALYSIS: A prospective, before-after, study. Previously well children aged≥6 months presenting to a paediatric emergency department (ED) that have at least one respiratory symptom/sign, receive chest radiography, and are diagnosed with CAP by the ED physician will be eligible. Those with medical comorbidities, recently diagnosed pulmonary infection, or ongoing fever after≥4 days of antimicrobial therapy will be excluded. In the control (before) phase, eligible participants will be managed as per the standard of care. In the intervention (after) phase, eligible participants will be managed as per the novel care pathway. The primary outcome will be the proportion of participants in each phase who receive antimicrobial treatment for CAP. The secondary outcomes include: clinical cure; re-presentation to the ED; hospitalisation; time to resolution of symptoms; drug adverse events; caregiver satisfaction; child absenteeism from daycare/school; and caregiver absenteeism from work. ETHICS AND DISSEMINATION: All study documentation has been approved by the Hamilton Integrated Research Ethics Board and informed consent will be obtained from all participants. Data from this study will be presented at major conferences and published in peer-reviewed publications to facilitate collaborations with networks of clinicians experienced in the dissemination of clinical guidelines. TRIAL REGISTRATION NUMBER: NCT05114161.


Assuntos
Infecções Comunitárias Adquiridas , Pneumonia , Criança , Humanos , Procedimentos Clínicos , Atenção Terciária à Saúde , Estudos de Coortes , Estudos Prospectivos , Canadá , Infecções Comunitárias Adquiridas/microbiologia , Pneumonia/diagnóstico , Pneumonia/tratamento farmacológico , Pneumonia/microbiologia , Antibacterianos/uso terapêutico , Hospitais Pediátricos , Serviço Hospitalar de Emergência
4.
Curr Oncol ; 29(10): 7624-7636, 2022 Oct 13.
Artigo em Inglês | MEDLINE | ID: mdl-36290879

RESUMO

Publicly funded healthcare systems, including those in Canada, the United Kingdom (UK), and Australia, often use health technology assessment (HTA) to inform drug reimbursement decision-making, based on dossiers submitted by manufacturers, and HTA agencies issue publicly available reports to support funding recommendations. However, the level of information reported by HTA agencies in these reports may vary. To provide insights on this issue, we describe and assess the reporting of economic methods in recent oncology HTA recommendations from the Canadian Agency for Drugs and Technologies in Health (CADTH), National Institute for Health and Care Excellence (NICE), and Pharmaceutical Benefits Advisory Committee (PBAC). Publicly available HTA recommendations and reports for oncology drugs issued by CADTH over a 2-year period, 2019-2020, were identified and compared with the corresponding HTA documents from NICE and the PBAC. Reporting of key model characteristics and attributes, survival analysis methods, methodological criticisms, and re-assessment of the economic results were characterized using descriptive statistics. Dichotomous differences in the methodological criticisms observed between the three agencies were assessed using Cochran's Q tests and substantiated using pairwise McNemar tests. Chi-squared tests were used to assess the dichotomous differences in the reporting of methods and explore the potential relationships between categorical variables, where appropriate. HTAs published by CADTH, NICE, and the PBAC consistently reported a broad spectrum of descriptive information on the economic models submitted by manufacturers. While common economic evaluation attributes were well-reported across the three HTA agencies, significant differences in the reporting of survival analysis methods and methodological criticisms were observed. NICE consistently reported more comprehensive information, compared to either CADTH or PBAC. Despite these differences, broadly similar recommendation rates were observed between CADTH and NICE. The PBAC was found to be more restrictive. Based on our 2-year sample of oncology, the HTAs published by CADTH matched with the corresponding HTAs from NICE and PBAC; we observed important variations in the reporting of economic evidence, especially technical aspects, such as survival analysis, across the three agencies. In addition to guidelines for HTA submissions by manufacturers, the community of HTA agencies should also have common standards for reporting the results of their assessments, though the information and opinions reported may differ.


Assuntos
Avaliação da Tecnologia Biomédica , Humanos , Avaliação da Tecnologia Biomédica/métodos , Análise Custo-Benefício , Canadá , Reino Unido , Preparações Farmacêuticas
5.
Diabetes Metab Res Rev ; : e3588, 2022 Oct 30.
Artigo em Inglês | MEDLINE | ID: mdl-36309818

RESUMO

BACKGROUND: It remained unknown about the status of and trends in racial/ethnic subgroup reporting in the diabetes trials over the past two decades. OBJECTIVES: In this survey, we aimed to evaluate the current state of and temporal trends in subgroup reporting by race/ethnicity regarding the effects of interventions in diabetes randomized controlled trials (RCTs) from year 2000-2020 and to explore the potential trial factors in relation to racial/ethnic subgroup reporting. METHODS: We searched electronic databases for eligible diabetes RCTs. The outcome was whether the trials had the event of racial/ethnic subgroup reporting regarding the intervention effects on trial primary outcomes. Poisson regression was used to assess the temporal trends in racial/ethnic subgroup reporting, and univariable logistic regression models were employed for evaluating trial factors related to racial/ethnic subgroup reporting. RESULTS: A total of 405 diabetes RCTs were eligible for inclusion. There were 26 (6.42%) trials with racial/ethnic subgroup reporting. A chronological trend towards increased rates of racial/ethnic subgroup reporting was observed; however, the trend was not statistically significant (p = 0.07). Advanced patients' age (Odds ratio [OR] = 2.92, 95% confidence interval [CI]: 1.24-6.88), follow-up duration (OR = 3.53, 95% CI: 1.13-11.00), and BIPOC (Black, Indigenous, and People of Colour) enrolment (OR = 2.39, 95% CI: 1.01-5.62) were found to positively relate with racial/ethnic subgroup reporting, while the industrial funding was associated with decreased reporting (OR = 0.43, 95% CI: 0.19-0.97). Less than one fourth of the trials with racial/ethnic subgroup reporting predefined the subgroup analysis. CONCLUSIONS: The majority of diabetes RCTs did not report intervention effects by racial/ethnic subgroup, which was not temporally improved over the past two decades. More efforts and strategies are needed to improve the racial/ethnic subgroup consideration and reporting in diabetes trials.

6.
JBMR Plus ; 6(10): e10679, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-36248272

RESUMO

Cognition, frailty, and falls have been examined independently as potential correlates of fracture risk, but not simultaneously. Our objective was to explore the association between cognition, frailty, and falls and self-reported incident fractures to determine if these factors show significant independent associations or interactions. We included participants who completed the Canadian Longitudinal Study on Aging (CLSA) 2012-2015 baseline comprehensive assessment, did not experience any self-reported fractures in the year prior to cohort recruitment, and completed the follow-up questionnaire at year 3 (n = 26,982). We compared all baseline cognitive measures available in the CLSA, the Rockwood Frailty Index (FI), and presence of self-reported falls in the past 12 months in those with versus without self-reported incident fractures in year 3 of follow-up. We used multivariable logistic regression adjusted for covariates and examined two-way interactions between cognition, frailty, and prior falls. CLSA specified analytic weights were applied. The mean ± standard error (SE) age of participants was 59.5 ± 0.1 years and 52.2% were female. A total of 715 participants (2.7%) self-reported incident fractures at 3-year follow-up. Participants who experienced incident fractures had similar baseline cognition scores (mean ± SE; Rey Auditory Verbal Learning Test [RAVLT]: Immediate recall 6.1 ± 0.1 versus 5.9 ± 0.0; standardized difference [d] 0.124); higher FI scores (mean ± SE; FI 0.134 ± 0.005 versus 0.116 ± 0.001; d 0.193), and a greater percentage had fallen in the past 12 months (weighted n [%] 518 [7.2] versus 919 [3.5]; d 0.165). FI (each increment of 0.08) was associated with a significantly increased risk of self-reported incident fractures in participants of all ages and those aged 65 years or older (adjusted odd ratio [OR] 1.24, 95% confidence limit [CL] 1.10-1.40; adjusted OR 1.44, 95% CL 1.11-1.52, respectively). The adjusted odds for self-reported incident fractures in participants of all ages was also significantly associated with falls in the past 12 months prior to baseline (adjusted OR 1.83; 95% CL 1.13-2.97), but not in those aged 65 years or older. No interactions between cognition, frailty, and prior falls were found. However, considering the relatively young age of our cohort, it may be appropriate to make strong inferences in individuals older than 65 years of age. © 2022 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

7.
Front Rehabil Sci ; 3: 995244, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36188946

RESUMO

Background: Loss of upper extremity function after tetraplegia results in significant disability. Emerging evidence from pilot studies suggests that functional electrical stimulation (FES) therapy may enhance recovery of upper extremity function after tetraplegia. The aim of this trial was to determine the effectiveness of FES therapy delivered by the Myndmove stimulator in people with tetraplegia. Methods: A multi-center, single-blind, parallel-group, two-arm, randomized controlled trial was conducted comparing FES to conventional therapy in adults (≥18 years) with C4-C7 traumatic incomplete tetraplegia between 4 and 96 months post-injury, and with a baseline spinal cord injury independence measure III -self-care (SCIM III-SC) score of ≤10. Participants were enrolled at four SCI-specialized neurorehabilitation centers in the U.S. and Canada. Participants were stratified by center and randomized in a 1:1 ratio to receive either 40 sessions of FES or conventional therapy targeting upper extremities over a 14-week period. Blinded assessors measured SCIM III, Toronto Rehabilitation Institute Hand Function Test, and Graded Redefined Assessment of Strength, Sensibility, and Prehension at baseline, after 20th session, after 40th session or 14 weeks after 1st session, and at 24 weeks after 1st session. The primary outcome measure was change in SCIM III-SC from baseline to end of the treatment. Based on the primary outcome measure, a sample size of 60 was calculated. Seventeen participants' progress in the study was interrupted due to the COVID-19 lockdown. The protocol was modified for these participants to allow them to complete the study. Results: Between June 2019 to August 2021, 51 participants were randomized to FES (n = 27) and conventional therapy (n = 24). Both groups gained a mean of 2 points in SCIM-SC scores at the end of treatment, which was a clinically meaningful change. However, there was no statistically significant difference between the groups on any outcomes. Conclusion: Forty sessions of FES therapy delivered by the MyndMove stimulator are as effective as conventional therapy in producing meaningful functional improvements that persist after therapy is completed. Limitations of this study include the impact of COVID-19 limiting the ability to recruit the target sample size and per-protocol execution of the study in one-third of the participants. Registration: This trial is registered at www.ClinicalTrials.gov, NCT03439319.

8.
Pilot Feasibility Stud ; 8(1): 224, 2022 Oct 04.
Artigo em Inglês | MEDLINE | ID: mdl-36192777

RESUMO

BACKGROUND: Pilot and feasibility studies (PAFS) are smaller investigations seeking to assess the feasibility of conducting a larger more definitive study. In late 2016, the CONSORT statement was extended to disseminate good practices for reporting of randomized pilot and feasibility trials. In this quality assurance review, we assessed whether PAFS in the top dental speciality journals adhere to good practices of conduct and reporting, by prioritizing assessment of feasibility and stating pre-defined progression criteria to inform the decision to pursue funding for a larger trial. METHODS: With the help of a librarian, we searched MEDLINE and EMBASE from 2017 to 2020, inclusive, for PAFS in the top 3 journals from each of the 10 dental specialties. We collected data on methodological and general characteristics of the studies, their objectives, and reporting of items recommended in the CONSORT extension. RESULTS: Of the 111 trials included, 51.4% (95% CI 41.7-61.0%) stated some indication of intent to assess feasibility while zero reported progression criteria; 74.8% (95% CI 65.6-82.5%) of trials used the terms "pilot" or "feasibility" in their titles and 82.9% (95% CI 74.6-89.4%) of studies stated there is a need for a future trial, but only 9.0% (95% CI 4.4-15.9%) stated intent to proceed to one. Most of the studies, 53.2% (95% CI 43.4-62.7%), reported hypothesis testing without cautioning readers on the generalizability of the results. Studies that used the terms "pilot" or "feasibility" in their title were less likely to have feasibility objectives, compared to trials that did not, with an odds ratio (OR) of 0.310 (95% CI 0.103-0.930; p = 0.037). Compared to trials that did not conduct hypothesis testing, trials that conducted hypothesis testing were significantly less likely to assess feasibility, among them, trials that cautioned readers on the generalizability of their results had an OR of 0.038 (95% CI 0.005-0.264; p < 0.001) and trials that did not caution readers on the generalizability of their results had an OR of 0.043 (95% CI 0.008-0.238; p = 0.001). CONCLUSION: Many PAFS in dentistry are not conducted with the intent of assessing feasibility, nor do they state progression criteria, and few report intent to proceed to a future trial. Misconceptions about PAFS can lead to them being poorly conducted and reported, which has economic and ethical implications. Research ethics boards, funding agencies, and journals need to raise their standards for the conduct and reporting of PAFS, and resources should be developed to address misconceptions and help guide researchers on the best practices for their conduct and reporting.

9.
Artigo em Inglês | MEDLINE | ID: mdl-36251889

RESUMO

Survivors of pediatric acute lymphoblastic leukemia (ALL) often have altered body composition secondary to treatment effects, including sarcopenic obesity (SO), which increases the risk of both metabolic complications and frailty. SO is difficult to detect without using advanced imaging techniques to which access is often limited. To explore whether common clinical indices can reliably identify the presence of SO in a cohort of long-term survivors of ALL, the discriminatory capacity of body mass index (BMI) or triponderal mass index (TMI, kg/m3) for detecting SO was assessed. Thresholds of BMI and TMI associated with overweight or obesity status had poor sensitivity (<50%) and specificity for detecting SO. Total misclassification rates at these thresholds exceeded 50% and positive likelihood ratios were nonsignificant. Notably, TMI is more strongly correlated with elevated adiposity than is BMI in this survivor population (R2=0.73 vs. 0.57), suggesting further exploration is warranted. Our study is limited by the sample size, precluding detailed regression analysis. This study highlights the challenges of identifying SO in survivors of pediatric ALL using common clinical indices. Prospective evaluation of additional potential surrogate markers in survivors, in conjunction with the component features of SO, should be a key focus of future research.

10.
Can J Pain ; 6(4): 1-2, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36213524

RESUMO

Background: Total knee arthroplasties are the second most common surgery in Canada. Most patients recover well, but 20% or more still suffer from persistent pain and opioid use. Though opioids are an important part of perioperative pain management, their potential for long-term adverse effects is well recognized. Limiting opioids may be insufficient to overcome the issue of opioid overuse. Pain and opioid use are highly linked, so an effective alternative needs to address both issues. Objectives: The principal objective of this pilot trial is to assess the feasibility. The clinical objectives are to determine the effects of a multicomponent care pathway on opioid-free pain control, persisting pain and opioid use, functional knee outcomes, quality of life, and return to function. Methods: We will include adult patients scheduled for primary elective total knee arthroplasty. Patients in the intervention group will undergo a multicomponent intervention pathway that will be facilitated by an intervention coordinator linking each patient and their surgical/ perioperative team. The interventional pathway will include (1) preoperative education on pain and opioid use, (2) preoperative risk identification and mitigation using cognitive behavioral skills, (3) personalized postdischarge analgesic prescriptions, and (4) continued support for pain control and recovery up to 8 weeks. Patients in the control group will receive the usual care at their institution. Discussion: The overarching goal is to implement and evaluate a coordinated approach to clinical care to improve pain control and reduce harms, with an emphasis on patient-centered care and shared decision making.Trial Registration Number: NCT04968132 (informed consent/ research ethics board statement).


Contexte: L'arthroplastie totale du genou est la deuxième chirurgie la plus courante au Canada. La plupart des patients se rétablissent bien, mais au moins 20 pour cent d'entre eux souffrent encore de douleur persistante et de consommation d'opioïdes. Bien que les opioïdes soient un élément important de la prise en charge périopératoire de la douleur, leur potentiel d'effets indésirables à long terme est bien reconnu. La limitation des opioïdes peut être insuffisante pour surmonter le problème de la surconsommation d'opioïdes. La douleur et la consommation d'opioïdes sont étroitement liées, de sorte qu'une option de rechange efficace doit s'attaquer à ces deux problèmes.Objectifs: L'objectif principal de cet essai pilote est d'évaluer la faisabilité. Les objectifs cliniques sont de déterminer les effets d'une voie de soins à composantes multiples sur la maitrise de la douleur sans opioïdes, la douleur persistante et la consommation d'opioïdes, les résultats fonctionnels du genou, la qualité de vie et le retour à la fonction.Méthodes: Nous inclurons les patients adultes devant subir une arthroplastie primaire totale élective du genou. Les patients du groupe d'intervention seront soumis à une voie d'intervention à composantes multiples qui sera facilitée par un coordonnateur d'intervention reliant chaque patient et son équipe chirurgicale/périopératoire. La voie d'intervention comprendra (1) une éducation préopératoire sur la douleur et la consommation d'opioïdes, (2) la détermination et l'atténuation des risques préopératoires à l'aide de compétences comportementales cognitives, (3) des prescriptions analgésiques personnalisées après la sortie, et (4) un soutien continu pour la maîtrise de la douleur et la récupération pendant une période allant jusqu'à huit semaines. Les patients du groupe témoin recevront les soins habituels à leur établissement.Discussion: L'objectif global est de mettre en œuvre et d'évaluer une approche coordonnée des soins cliniques afin d'améliorer la maitrise de la douleur et réduire les méfaits, en mettant l'accent sur les soins centrés sur le patient et la prise de décision partagée. Numéro d'enregistrement de l'essai : NCT04968132 (consentement éclairé/déclaration du comité d'éthique de la recherche).

11.
Syst Rev ; 11(1): 229, 2022 Oct 25.
Artigo em Inglês | MEDLINE | ID: mdl-36284336

RESUMO

BACKGROUND: Cluster randomized trials (CRTs) are becoming an increasingly important design. However, authors of CRTs do not always adhere to requirements to explicitly identify the design as cluster randomized in titles and abstracts, making retrieval from bibliographic databases difficult. Machine learning algorithms may improve their identification and retrieval. Therefore, we aimed to develop machine learning algorithms that accurately determine whether a bibliographic citation is a CRT report. METHODS: We trained, internally validated, and externally validated two convolutional neural networks and one support vector machine (SVM) algorithm to predict whether a citation is a CRT report or not. We exclusively used the information in an article citation, including the title, abstract, keywords, and subject headings. The algorithms' output was a probability from 0 to 1. We assessed algorithm performance using the area under the receiver operating characteristic (AUC) curves. Each algorithm's performance was evaluated individually and together as an ensemble. We randomly selected 5000 from 87,633 citations to train and internally validate our algorithms. Of the 5000 selected citations, 589 (12%) were confirmed CRT reports. We then externally validated our algorithms on an independent set of 1916 randomized trial citations, with 665 (35%) confirmed CRT reports. RESULTS: In internal validation, the ensemble algorithm discriminated best for identifying CRT reports with an AUC of 98.6% (95% confidence interval: 97.8%, 99.4%), sensitivity of 97.7% (94.3%, 100%), and specificity of 85.0% (81.8%, 88.1%). In external validation, the ensemble algorithm had an AUC of 97.8% (97.0%, 98.5%), sensitivity of 97.6% (96.4%, 98.6%), and specificity of 78.2% (75.9%, 80.4%)). All three individual algorithms performed well, but less so than the ensemble. CONCLUSIONS: We successfully developed high-performance algorithms that identified whether a citation was a CRT report with high sensitivity and moderately high specificity. We provide open-source software to facilitate the use of our algorithms in practice.


Assuntos
Algoritmos , Aprendizado de Máquina , Humanos , MEDLINE , Ensaios Clínicos Controlados Aleatórios como Assunto , Descritores , Máquina de Vetores de Suporte
12.
Can J Anaesth ; 69(12): 1515-1526, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36289153

RESUMO

PURPOSE: We sought to compare the cost-effectiveness of probiotics and usual care with usual care without probiotics in mechanically ventilated, intensive care unit patients alongside the Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT). METHODS: We conducted a health economic evaluation alongside the PROSPECT randomized control trial (October 2013-March 2019). We adopted a public healthcare payer's perspective. Forty-four intensive care units in three countries (Canada/USA/Saudi Arabia) with adult critically ill, mechanically ventilated patients (N = 2,650) were included. Interventions were probiotics (Lactobacillus rhamnosus GG) vs placebo administered enterally twice daily. We collected healthcare resource use and estimated unit costs in 2019 United States dollars (USD) over a time horizon from randomization to hospital discharge/death. We calculated incremental cost-effectiveness ratios (ICERs) comparing probiotics vs usual care. The primary outcome was incremental cost per ventilator-associated pneumonia (VAP) event averted; secondary outcomes were costs per Clostridioides difficile-associated diarrhea (CDAD), antibiotic-associated diarrhea (AAD), and mortality averted. Uncertainty was investigated using nonparametric bootstrapping and sensitivity analyses. RESULTS: Mean (standard deviation [SD]) cost per patient was USD 66,914 (91,098) for patients randomized to probiotics, with a median [interquartile range (IQR)] of USD 42,947 [22,239 to 76,205]. By comparison, for those not receiving probiotics, mean (SD) cost per patient was USD 62,701 (78,676) (median [IQR], USD 41,102 [23,170 to 75,140]; incremental cost, USD 4,213; 95% confidence interval [CI], -2,269 to 10,708). Incremental cost-effectiveness ratios for VAP or AAD events averted, probiotics were dominated by usual care (more expensive, with similar effectiveness). The ICERs were USD 1,473,400 per CDAD event averted (95% CI, undefined) and USD 396,764 per death averted (95% CI, undefined). Cost-effectiveness acceptability curves reveal that probiotics were not cost-effective across wide ranges of plausible willingness-to-pay thresholds. Sensitivity analyses did not change the conclusions. CONCLUSIONS: Probiotics for VAP prevention among critically ill patients were not cost-effective. Study registration data www. CLINICALTRIALS: gov (NCT01782755); registered 4 February 2013.


RéSUMé: OBJECTIF: Nous avons cherché à comparer le rapport coût-efficacité d'un traitement avec probiotiques ajoutés aux soins habituels avec des soins habituels prodigués sans probiotiques chez les patients des soins intensifs sous ventilation mécanique dans le cadre de l'étude PROSPECT (Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial). MéTHODE: Nous avons réalisé une évaluation de l'économie de la santé parallèlement à l'étude randomisée contrôlée PROSPECT (octobre 2013-mars 2019). Nous avons adopté le point de vue d'un payeur public de services de santé. Quarante-quatre unités de soins intensifs dans trois pays (Canada/États-Unis/Arabie saoudite) prenant soin de patients adultes gravement malades sous ventilation mécanique (n = 2650) ont été inclus. Les interventions ont été les suivantes : probiotiques (Lactobacillus rhamnosus GG) vs placebo administrés par voie entérale deux fois par jour. Nous avons recueilli les données concernant l'utilisation des ressources en soins de santé et estimé les coûts unitaires en dollars américains (USD) de 2019 sur un horizon temporel allant de la randomisation au congé de l'hôpital / décès. Nous avons calculé des rapports coût-efficacité différentiels (RCED) en comparant les probiotiques vs les soins habituels. Le critère d'évaluation principal était le coût différentiel par événement évité de pneumonie associée au ventilateur (PAV); les critères d'évaluation secondaires étaient les coûts par diarrhée associée au Clostridioides difficile (DACD), diarrhée associée aux antibiotiques (DAA) et mortalité évitées. L'incertitude a été étudiée à l'aide d'analyses d'amorçage et de sensibilité non paramétriques. RéSULTATS: Le coût moyen (écart type [ÉT]) par patient était de 66 914 (91 098) USD pour les patients randomisés au groupe probiotiques, avec une médiane [écart interquartile (ÉIQ)] de 42 947 USD [22 239 à 76 205]. En comparaison, pour ceux ne recevant pas de probiotiques, le coût moyen (ÉT) par patient était de 62 701 USD (78 676) (médiane [ÉIQ], 41 102 USD [23 170 à 75 140]; coût différentiel, 4213 USD; intervalle de confiance [IC] à 95%, -2269 à 10 708). En matière de rapports coût-efficacité différentiels pour les événements de PAV ou DAA évités, les probiotiques étaient dominés par les soins habituels (plus coûteux, avec une efficacité similaire). Les RCED étaient de 1 473 400 USD par événement de DACD évitée (IC 95 %, non défini) et de 396 764 USD par décès évité (IC 95 %, non défini). Les courbes d'acceptabilité coût-efficacité révèlent que les probiotiques n'étaient pas rentables dans de larges gammes de seuils plausibles de volonté de payer. Les analyses de sensibilité n'ont pas modifié les conclusions. CONCLUSION: Les probiotiques utilisés pour prévenir la PAV chez les patients gravement malades n'étaient pas rentables. Enregistrement de l'étude : www.clinicaltrials.gov (NCT01782755); enregistrée le 4 février 2013.


Assuntos
Pneumonia Associada à Ventilação Mecânica , Probióticos , Adulto , Humanos , Análise Custo-Benefício , Estado Terminal , Probióticos/uso terapêutico , Pneumonia Associada à Ventilação Mecânica/prevenção & controle , Diarreia/prevenção & controle
13.
Artigo em Inglês | MEDLINE | ID: mdl-36108334

RESUMO

Exercise and nutrition interventions are often recommended for frailty; however, effective strategies are required for real-world implementation. Our primary aim was to assess the feasibility and acceptability of telephone and virtual delivery of MoveStrong, an 8-week exercise and nutrition program with a 4-week follow-up for older pre-frail and frail adults. A priori criteria for success included: recruitment (≥25/12 weeks), retention at follow-up (≥80%), and adherence to exercise and nutrition sessions (≥70%). We recruited community-dwelling Ontario residents; ≥60 years, ≥1 chronic condition, ≥1 FRAIL scale score. Participants received mailed materials, a personalized exercise program, 11 remote one-on-one training sessions with an exercise physiologist and 3 online dietitian-led nutrition education sessions. We completed exploratory analyses of secondary outcomes including physical function and dietary protein intake. Semi-structured interviews supported program evaluation. In total, 30 participants were enrolled. 28 (93%) participants completed program and follow-up assessments. Adherence to exercise and nutrition sessions (CI) was 84% (77%-91%) and 82% (70%-93%) respectively. At program end and follow-up [mean change (CI)], significant improvements were measured in 30-second chair stand test [3.50 (1.12-5.86), 4.54 (1.94-7.13) chair stands] and dietary protein intake [12.9 (5.7-20.0), 9.2 (0.4-18.1) g]. Overall, participants were satisfied with program delivery. Trial registration number: NCT04663685.

14.
CMAJ Open ; 10(3): E848-E855, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36167420

RESUMO

BACKGROUND: In 2018, Ontario implemented a pharmacare program (Ontario Health Insurance Plan Plus [OHIP+]) to provide children and youth younger than 25 years with full coverage for prescription medications in the provincial formulary. We aimed to assess the use of public drug plans and costs of publicly covered prescriptions before and after the program's implementation and modification. METHODS: We conducted a population-based, interrupted time-series analysis using data on prescription drug claims, from the Canadian Institute for Health Information's National Prescription Drug Utilization Information System, for people younger than 25 years from January 2016 to October 2019 in Ontario, using British Columbia as the control. We assessed changes in the level and trend of publicly covered prescriptions and expenditures after the introduction of OHIP+ in January 2018 and after program modifications in April 2019. We also assessed plan use and expenditures for publicly covered prescriptions for diabetes and asthma. RESULTS: Publicly covered prescriptions in Ontario increased by 290%, from 756 per 1000 people before OHIP+ to 2952 per 1000 (p < 0.001) after its implementation. After program modification, prescriptions decreased by 52% to 1421 per 1000 (p < 0.001). Similarly, total public drug expenditures increased by 254%, from $379 million in 2017 to $839 million in 2018, then reduced by 49% to $204 million in 2019. Monthly public plan expenditures increased by $115.94 (95% confidence interval [CI] $100.93 to $130.94) post-OHIP+ implementation and decreased by $99.97 (95% CI -$119.79 to -$80.15) per person per month after April 2019. INTERPRETATION: Adopting OHIP+ increased use of public drug plans and expenditures for publicly funded prescription medicines, and the program modification was associated with decreases in both outcomes. This study's findings can inform the national pharmacare debate; future research should investigate associations with health outcomes.


Assuntos
Medicamentos sob Prescrição , Adolescente , Colúmbia Britânica/epidemiologia , Criança , Custos e Análise de Custo , Gastos em Saúde , Humanos , Ontário/epidemiologia , Medicamentos sob Prescrição/uso terapêutico
15.
Afr J Disabil ; 11: 1004, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36092478

RESUMO

Background: Physical rehabilitation interventions address functional deficits caused by impairments that affect someone's performance. Whilst rehabilitation is important, it is assumed that these services are either minimal or nonexistent in low-resource settings. Our data expand on the data from the Situation Assessment of Rehabilitation in the Republic of Rwanda report to describe rehabilitation services and who access them at public and semiprivate facilities (primarily funded by the private sector). Objectives: This article describes the use of the outpatient physical rehabilitation services across nine health facilities, the characteristics of adults attending these health facilities and some of the facilitators and barriers they encounter when attending rehabilitation. Method: Data were collected between September and December 2018 from the heads of departments and adult patients attending outpatient rehabilitation services funded by the government, international nongovernmental organisations or faith-based organisations. Results: Two hundred and thirteen adults were recruited from nine facilities. There is a sixfold difference in the number of rehabilitation personnel between public and semiprivate hospitals in these facilities' catchment areas. However, most participants were recruited at public facilities (186 [87%]), primarily with physical disorders. Patients reported that family support (94%) was the most crucial facilitator for attending rehabilitation, whilst transportation cost (96%) was a significant barrier. Conclusion: Rehabilitation service availability for Rwandan adults with disabilities is limited. Whilst family support helps patients attend rehabilitation, transportation costs remain a significant barrier to people attending rehabilitation. Strategies to address these issues include developing triage protocols, training community health workers and families. Contribution: Data on rehabilitation service provision in Rwanda and most African countries are either non-existent or very limited. These data contain important information regarding the services provided and the people who used them across different health facilities (public versus private) and urban versus rural settings). To improve rehabilitation service provision, we first need to understand the current situation. These data are an important step to better understanding rehabilitation in Rwanda.

16.
Trials ; 23(1): 772, 2022 Sep 12.
Artigo em Inglês | MEDLINE | ID: mdl-36096826

RESUMO

BACKGROUND: Approximately 1 in 10 patients with a surgically treated open fracture will develop a surgical site infection. The Aqueous-PREP trial will investigate the effect of 10% povidone-iodine versus 4% chlorhexidine in aqueous antiseptic solutions in reducing infections after open fracture surgery. The study protocol was published in April 2020. METHODS AND DESIGN: The Aqueous-PREP trial is a pragmatic, multicenter, open-label, randomized multiple period cluster crossover trial. Each participating cluster is randomly assigned in a 1:1 ratio to provide 1 of the 2 study interventions on all eligible patients during a study period. The intervention periods are 2 months in length. After completing a 2-month period, the participating cluster crosses over to the alternative intervention. We plan to enroll a minimum of 1540 patients at 14 sites. RESULTS: The primary outcome is surgical site infection guided by the Centers for Disease Control and Prevention's National Healthcare Safety Network reporting criteria (2017). All participants' surgical site infection surveillance period will end 30 days after definitive fracture management surgery for superficial infections and 90 days after definitive fracture management surgery for deep incisional or organ/space infections [1]. The secondary outcome is an unplanned fracture-related reoperation within 12 months of the fracture. CONCLUSION: This manuscript serves as the formal statistical analysis plan (version 1.0) for the Aqueous-PREP trial. The statistical analysis plan was completed on February 28, 2022.


Assuntos
Anti-Infecciosos Locais , Fraturas Expostas , Anti-Infecciosos Locais/efeitos adversos , Clorexidina/efeitos adversos , Fraturas Expostas/cirurgia , Humanos , Povidona-Iodo/efeitos adversos , Infecção da Ferida Cirúrgica/epidemiologia , Infecção da Ferida Cirúrgica/prevenção & controle , Estados Unidos , Água
17.
BMJ Open ; 12(9): e065287, 2022 09 26.
Artigo em Inglês | MEDLINE | ID: mdl-36167361

RESUMO

INTRODUCTION: The rates of type 2 diabetes mellitus (T2DM) in children and adolescents have risen globally over the past few years. While a few diabetes pharmacotherapies have been used in this population, their comparative benefits and harms are unclear. Thus, we will conduct a systematic review and network meta-analysis (NMA) of randomised controlled trials (RCTs) to compare the efficacy and safety of pharmacotherapies for managing paediatric T2DM. METHODS AND ANALYSIS: We will include RCTs that enrolled T2DM patients ≤18 years of age and who were randomised to monotherapy or combination pharmacotherapies with or without lifestyle interventions. Comparator groups will include placebo or non-pharmacological treatments including lifestyle interventions.Treatment outcomes will include change from baseline in glycated haemoglobin A1c, body mass index z-score, weight, systolic/diastolic blood pressure, fasting plasma glucose, fasting insulin and lipid profiles, T2DM-related complications, as well as the incidence of treatment-related adverse events.Literature searches will be conducted in Medline, Embase, CINAHL, CENTRAL and Web of Science. We will also search the grey literature and the reference list of included trials and relevant reviews. Two reviewers will assess the eligibility of articles identified through our searches and will extract data from eligible studies independently. We will use a modified Cochrane instrument to evaluate the risk of bias. Disagreements will be resolved through consensus or arbitration by a third reviewer.A frequentist random-effects model will be used for conducting NMA. The quality of evidence will be assessed using the Confidence in Network Meta-Analysis platform. We will assess the effect modification through network meta-regression and subgroup analyses for sex, age at study inclusion, duration of T2DM, follow-up duration and risk of bias ratings. ETHICS AND DISSEMINATION: This study will not require ethics approval. We will disseminate our findings through publication in a peer-reviewed journal and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42022310100.


Assuntos
Glicemia , Diabetes Mellitus Tipo 2 , Adolescente , Criança , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hemoglobina A Glicada , Humanos , Insulina/uso terapêutico , Lipídeos , Metanálise como Assunto , Metanálise em Rede , Ensaios Clínicos Controlados Aleatórios como Assunto , Revisões Sistemáticas como Assunto
18.
Trials ; 23(1): 735, 2022 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-36056378

RESUMO

RATIONALE: The COVID-19 pandemic disrupted non-COVID critical care trials globally as intensive care units (ICUs) prioritized patient care and COVID-specific research. The international randomized controlled trial CYCLE (Critical Care Cycling to Improve Lower Extremity Strength) was forced to halt recruitment at all sites in March 2020, creating immediate challenges. We applied the CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstance) statement as a framework to report the impact of the pandemic on CYCLE and describe our mitigation approaches. METHODS: On March 23, 2020, the CYCLE Methods Centre distributed a standardized email to determine the number of patients still in-hospital and those requiring imminent 90-day endpoint assessments. We assessed protocol fidelity by documenting attempts to provide the in-hospital randomized intervention (cycling or routine physiotherapy) and collect the primary outcome (physical function 3-days post-ICU discharge) and 90-day outcomes. We advised sites to prioritize data for the study's primary outcome. We sought feedback on pandemic barriers related to trial procedures. RESULTS: Our main Methods Centre mitigation strategies included identifying patients at risk for protocol deviations, communicating early and frequently with sites, developing standardized internal tools focused on high-risk points in the protocol for monitoring patient progress, data entry, and validation, and providing guidance to conduct some research activities remotely. For study sites, our strategies included determining how institutional pandemic research policies applied to CYCLE, communicating with the Methods Centre about capacity to continue any part of the research, and developing contingency plans to ensure the protocol was delivered as intended. From 15 active sites (12 Canada, 2 US, 1 Australia), 5 patients were still receiving the study intervention in ICUs, 6 required primary outcomes, and 17 required 90-day assessments. With these mitigation strategies, we attempted 100% of ICU interventions, 83% of primary outcomes, and 100% of 90-day assessments per our protocol. CONCLUSIONS: We retained all enrolled patients with minimal missing data using several time-sensitive strategies. Although CONSERVE recommends reporting only major modifications incurred by extenuating circumstances, we suggest that it also provides a helpful framework for reporting mitigation strategies with the goal of improving research transparency and trial management. TRIAL REGISTRATION: NCT03471247. Registered on March 20, 2018.


Assuntos
COVID-19 , Pandemias , Estado Terminal/reabilitação , Humanos , Unidades de Terapia Intensiva , SARS-CoV-2 , Resultado do Tratamento
19.
Menopause ; 29(10): 1210-1221, 2022 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-36067398

RESUMO

IMPORTANCE: Perimenopausal and postmenopausal women commonly report sleep disruption and insomnia. Behavioral interventions may be safe alternatives for patients who are unwilling to begin pharmacological treatments because of adverse effects, contraindications, or personal preference. OBJECTIVE: The primary objective is to assess the efficacy of behavioral interventions on sleep outcomes among perimenopausal and postmenopausal women, as measured using standardized scales and objective methods (polysomnography, actigraphy). The secondary objective is to evaluate the safety of these methods through occurrence of adverse events. EVIDENCE REVIEW: Searches were performed within MEDLINE (OVID interface, 1946 onward), Embase (OVID interface, 1974 onward), Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, and Web of Science (Core collection) using a search strategy developed in consultation with a health sciences librarian. Title/abstract and full-text screenings were performed in duplicate, and relevant studies were selected based on inclusion and exclusion criteria set to identify randomized controlled trials evaluating the effects of behavioral interventions on sleep quality. Risk of bias assessments were done using the Cochrane Risk of Bias 2 tool, and the Grading of Recommendations Assessment, Development and Evaluation approach was used to assess the certainty of the body of evidence. Data were pooled in a meta-analysis using a random-effects model. FINDINGS: Nineteen articles reporting results from 16 randomized controlled trials were included, representing a total of 2,108 perimenopausal and postmenopausal women. Overall, behavioral interventions showed a statistically significant effect on sleep outcomes (standardized mean difference [SMD], -0.62; 95% confidence interval [CI], -0.88 to -0.35; I2 = 93.4%). Subgroup analyses revealed that cognitive behavioral therapy (SMD, -0.40; 95% CI, -0.70 to -0.11; I2 = 72.7%), physical exercise (SMD, -0.57; 95% CI, -0.94 to -0.21; I2 = 94.0%), and mindfulness/relaxation (SMD, -1.28; 95% CI, -2.20 to -0.37; I2 = 96.0%) improved sleep, as measured using both subjective (eg, Pittsburg Sleep Quality Index) and objective measures. Low-intensity (SMD, -0.91; 95% CI, -1.59 to -0.24; I2 = 96.8) and moderate-intensity exercise (SMD, -0.21; 95% CI, -0.34 to -0.08; I2 = 0.0%) also improved sleep outcomes. No serious adverse events were reported. Overall risk of bias ranged from some concern to serious, and the certainty of the body of evidence was assessed to be of very low quality. CONCLUSIONS AND RELEVANCE: This meta-analysis provides evidence that behavioral interventions, specifically, cognitive behavioral therapy, physical exercise, and mindfulness/relaxation, are effective treatments for improving sleep outcomes among perimenopausal and postmenopausal women.


Assuntos
Terapia Cognitivo-Comportamental , Distúrbios do Início e da Manutenção do Sono , Terapia Cognitivo-Comportamental/métodos , Exercício Físico , Feminino , Humanos , Menopausa , Sono , Distúrbios do Início e da Manutenção do Sono/terapia
20.
BMC Med ; 20(1): 294, 2022 09 16.
Artigo em Inglês | MEDLINE | ID: mdl-36109742

RESUMO

BACKGROUND: Lack of representativeness in Black, Indigenous, and People of Colour (BIPOC) enrollment could compromise the generalizability of study results and health equity. This study aimed to examine trends in BIPOC groups enrollment in diabetes randomized controlled trials (RCTs) and to explore the association between trial factors and high-enrollment of BIPOC groups. METHODS: We systematically searched the literature on large diabetes RCTs with a sample size of ≥ 400 participants published between 2000 and 2020. We assessed temporal trends in enrollment of racial and ethnic groups in the included trials. Logistic and linear regression analyses were used to explore the relationship between trial factors and the high-enrollment defined by median enrollment rate. RESULTS: A total of 405 RCTs were included for analyses. The median enrollment rate of BIPOC groups was 24.0%, with 6.4% for the Black group, 11.2% for Hispanic, 8.5% for Asian, and 3.0% for other BIPOC groups respectively. Over the past 20 years, the BIPOC enrollment showed an increased trend in the diabetes RCTs, ranging from 20.1 to 28.4% (P for trend = 0.041). A significant trend towards increased enrollment for Asian group was observed. We found that weekly or daily intervention frequency (OR = 0.48, 95% CI: 0.26, 0.91) and duration of intervention > 6.5 month (OR = 0.59, 95% CI: 0.37, 0.95) were significantly related to decreased odds of high-enrollment, while type 2 diabetes (OR = 1.44, 95% CI: 1.04, 1.99) was associated with high-enrollment of BIPOC groups. CONCLUSIONS: The enrollment of BIPOC was found to increase in large diabetes RCTs over the past two decades; some trial factors may be significantly associated with BIPOC enrollment. These findings may highlight the importance of enrollment of BIPOC groups and provide insights into the design and implementation of future clinical trials in diabetes.


Assuntos
Diabetes Mellitus Tipo 2 , Etnicidade , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Tamanho da Amostra
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