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1.
Intensive Care Med ; 2021 Apr 19.
Artigo em Inglês | MEDLINE | ID: mdl-33876268

RESUMO

PURPOSE: Corticosteroids are now recommended for patients with severe COVID-19 including those with COVID-related ARDS. This has generated renewed interest regarding whether corticosteroids should be used in non-COVID ARDS as well. The objective of this study was to summarize all RCTs examining the use of corticosteroids in ARDS. METHODS: The protocol of this study was pre-registered on PROSPERO (CRD42020200659). We searched online databases including MEDLINE, EMBASE, CDC library of COVID research, CINAHL, and COCHRANE. We included RCTs that compared the effect of corticosteroids to placebo or usual care in adult patients with ARDS, including patients with COVID-19. Three reviewers abstracted data independently and in duplicate using a pre-specified standardized form. We assessed individual study risk of bias using the revised Cochrane ROB-2 tool and rated certainty in outcomes using GRADE methodology. We pooled data using a random effects model. The main outcome for this review was 28-day-mortality. RESULTS: We included 18 RCTs enrolling 2826 patients. The use of corticosteroids probably reduced mortality in patients with ARDS of any etiology (2740 patients in 16 trials, RR 0.82, 95% CI 0.72-0.95, ARR 8.0%, 95% CI 2.2-12.5%, moderate certainty). Patients who received a longer course of corticosteroids (over 7 days) had higher rates of survival compared to a shorter course. CONCLUSION: The use of corticosteroids probably reduces mortality in patients with ARDS. This effect was consistent between patients with COVID-19 and non-COVID-19 ARDS, corticosteroid types, and dosage.

2.
BMC Med Res Methodol ; 21(1): 76, 2021 Apr 19.
Artigo em Inglês | MEDLINE | ID: mdl-33874897

RESUMO

BACKGROUND: The expansion of access to antiretroviral therapy (ART) has been accompanied by an increase in pre-treatment drug resistance (PDR). While it is critical to monitor the increasing prevalence of PDR across countries and populations to inform optimal regimen selection, the completeness of reporting is often suboptimal, limiting the interpretation and generalizability of the results. Indeed, there is no formal guidance on how studies investigating the prevalence of drug resistance should be reported. Thus, we sought to determine the completeness of reporting in studies of PDR and the factors associated with sub-optimal reporting to ascertain the need for guidelines. METHODS: As part of a systematic review on the global prevalence of PDR in key populations (men who have sex with men, sex workers, transgender people, people who inject drugs and people in prisons), we searched 10 electronic databases until January 2019. We extracted information on selected study characteristics useful for interpreting prevalence data. Data were extracted in duplicate. Analyses of variance and correlation were used to explore factors that may explain the number of items reported. RESULTS: We found 650 studies of which 387 were screened as full text and 234 were deemed eligible. The included studies were published between 1997 and 2019 and included a median of 239 (quartile 1 = 101; quartile 3 = 778) participants. Most studies originated from high-income countries (125/234; 53.0%). Of 23 relevant data items, including study design, setting, participant sociodemographic characteristics, HIV risk factors, type of resistance test conducted, definition of resistance, the mean (standard deviation) number of items reported was 13 (2.2). We found that more items were reported in studies published more recently (r = 0.20; p < 0.002) and in studies at low risk of bias (F [2231] = 8.142; p < 0.001). CONCLUSIONS: Incomplete reporting in studies on PDR makes characterising levels of PDR in subpopulations across countries challenging. Hence, guidelines are needed to define a minimum set of variables to be included in such studies.

3.
PLoS One ; 16(4): e0246766, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33798201

RESUMO

BACKGROUND: Knowledge of HIV drug resistance informs the choice of regimens and ensures that the most efficacious options are selected. In January 2014, a policy change to routine resistance testing was implemented in Ontario, Canada. The objective of this study was to investigate the policy change impact of routine resistance testing in people with HIV in Ontario, Canada since January 2014. METHODS: We used data on people with HIV living in Ontario from administrative databases of the Institute for Clinical Evaluative Sciences (ICES) and Public Health Ontario (PHO), and ran ordinary least squares (OLS) models of interrupted time series to measure the levels and trends of 2-year mortality, 2-year hospitalizations and 2-year emergency department visits before (2005-2013) and after the policy change (2014-2017). Outcomes were collected in biannual periods, generating 18 periods before the intervention and 8 periods after. We included a control series of people who did not receive a resistance test within 3 months of HIV diagnosis. RESULTS: Data included 12,996 people with HIV, of which 8881 (68.3%) were diagnosed between 2005 and 2013, and 4115 (31.7%) were diagnosed between 2014 and 2017. Policy change to routine resistance testing within 3 months of HIV diagnosis led to a decreasing trend in 2-year mortality of 0.8% every six months compared to the control group. No significant differences in hospitalizations or emergency department visits were noted. INTERPRETATION: The policy of routine resistance testing within three months of diagnosis is beneficial at the population level.

4.
Pilot Feasibility Stud ; 7(1): 96, 2021 Apr 16.
Artigo em Inglês | MEDLINE | ID: mdl-33863400

RESUMO

BACKGROUND: Pilot and feasibility studies (PAFS) often have complex objectives aimed at assessing feasibility of conducting a larger study. These may not be clear to participants in pilot studies. METHODS: Here, we aimed to assess the transparency of informed consent in PAFS by investigating whether researchers communicate, through patient information leaflets and consent forms, key features of the studies. We collected this data from original versions of these documents submitted for ethics approval and the final approved documents for PAFS submitted to the Hamilton Integrated Research Ethics Board, Canada. RESULTS: One hundred eighty-four PAFS, submitted for ethics approval from 2004 to 2020, were included, and we found that of the approved consent documents which were provided to participants, 83.2% (153) stated the terms "pilot" or "feasibility" in their title, 12% (22) stated the definition of a pilot/feasibility study, 42.4% (78) of the studies stated their intent to assess feasibility, 19.6% (36) stated the specific feasibility objectives, 1.6% (3) stated the criteria for success of the pilot study, and 0.5% (1) stated all five of these criteria. After ethics review, a small increase in transparency occurred, ranging from 1.6 to 2.8% depending on the criteria. By extracting data from the protocols of the PAFS, we found that 73.9% (136) stated intent to assess feasibility, 71.2% (131) stated specific feasibility objectives, and 33.7% (62) stated criteria for success of the study to lead to a larger study. CONCLUSION: The transparency of informed consent in PAFS is inadequate and needs to be specifically addressed by research ethics guidelines. Research ethics boards and researchers ought to be made aware and mindful of best practices of informed consent in the context of PAFS.

5.
Korean J Pain ; 34(2): 139-155, 2021 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-33785666

RESUMO

The quality of subgroup analyses (SGAs) in chronic non-cancer pain trials is uncertain. The purpose of this study was to address this issue. We conducted a comprehensive search in MEDLINE and EMBASE from January 2012 to September 2018 to identify eligible trials. Two pairs of reviewers assessed the quality of the SGAs and the credibility of subgroup claims using the 10 criteria developed by Sun et al. in 2012. The associations between the quality of the SGAs and the studies' characteristics including risk of bias, funding sources, sample size, and the latest impact factor, were assessed using multivariable logistic regression. Our search retrieved 3,401 articles of which 66 were eligible. The total number of SGAs was 177 of which 52 (29.4%) made a subgroup claim. Of these, only 15 (8.5%) were evaluated as being of high quality. Among the 30 SGAs that claimed subgroup effects using an appropriate method of performing interaction tests, the credibility of only 5 were assessed as high. None of the subgroup claims met all the credibility criteria. No significant association was found between the quality of SGAs and the studies' characteristics. The quality of the SGAs performed in chronic pain trials was poor. To enhance the quality of SGAs, scholars should consider the developed criteria when designing and conducting trials, particularly those which need to be specified a priori .

6.
J Int AIDS Soc ; 24(3): e25674, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33713571

RESUMO

INTRODUCTION: HIV-related risks may be exacerbated in humanitarian contexts. Uganda hosts 1.3 million refugees, of which 60% are aged under 18. There are knowledge gaps regarding HIV testing facilitators and barriers, including HIV and intersecting stigmas, among urban refugee youth. In response, we explored experiences and perspectives towards HIV testing strategies, including HIV self-testing, with urban refugee youth in Kampala, Uganda. METHODS: We implemented a qualitative study with refugee cisgender youth aged 16 to 24 living in Kampala's informal settlements from February-April 2019. We conducted five focus groups with refugee youth, including two with adolescent boys and young men, two with adolescent girls and young women and one with female sex workers. We also conducted five key informant (KI) interviews with government, non-government and community refugee agencies and HIV service providers. We conducted thematic analyses to understand HIV testing experiences, perspectives and recommendations. RESULTS: Participants (n = 49) included young men (n = 17) and young women (n = 27) originally from the Democratic Republic of Congo [DRC] (n = 29), Rwanda (n = 11), Burundi (n = 3) and Sudan (n = 1), in addition to five KI (gender: n = 3 women, n = 2 men; country of origin: n = 2 Rwanda, n = 2 Uganda, n = 1 DRC). Participant narratives revealed stigma drivers included fear of HIV infection; misinformation that HIV is a "Ugandan disease"; and blame and shame for sexual activity. Stigma facilitators included legal precarity regarding sex work, same-sex practices and immigration status, alongside healthcare mistreatment and confidentiality concerns. Stigma experiences were attributed to the social devaluation of intersecting identities (sex work, youth, refugees, sexual minorities, people living with HIV, women). Participants expressed high interest in HIV self-testing. They recommended HIV self-testing implementation strategies to be peer supported and expressed concerns regarding sexual- and gender-based violence with partner testing. CONCLUSIONS: Intersecting stigma rooted in fear, misinformation, blame and shame, legal precarity and healthcare mistreatment constrain current HIV testing strategies with urban refugee youth. Findings align with the Health Stigma and Discrimination Framework that conceptualizes stigma drivers and facilitators that devalue intersecting health conditions and social identities. Findings can inform multi-level strategies to foster enabling HIV testing environments with urban refugee youth, including tackling intersecting stigma and leveraging refugee youth peer support.

7.
BMJ Open ; 11(3): e043055, 2021 Mar 25.
Artigo em Inglês | MEDLINE | ID: mdl-33766840

RESUMO

INTRODUCTION: Globally, rates of HIV are disproportionately high among black men who have sex with men (MSM). In Canada, race, gender and sexuality have been investigated as separate factors that influence quality of care within and progression along the HIV care continuum. Traditional compartmental approaches to synthesising the HIV care continuum literature do not sufficiently account for intersectional experiences and marginalisation of Black MSM (BMSM). Moreover, there is limited research outlining access to and quality of care as specific barriers to progression along the care continuum among BMSM in Canada. OBJECTIVES: The primary objective of this scoping review is to assess the state of the science regarding the influence of access to and quality of HIV care continuum outcomes for BMSM in Canada. METHODS AND ANALYSIS: We will conduct a systematic search of published literature of quantitative and qualitative studies published on Canadian BMSM's healthcare and HIV status. The searches will be conducted through MEDLINE, Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Library, the NHUS Economic Development Database, Global Health, APA PsychInfo, PubMed and Web of Science. ELIGIBILITY CRITERIA: Eligible studies will include data on black MSM living with or without HIV in Canada and must be published after 1983 in either English or French. Screening and data extraction will be conducted in duplicate. Any discrepancies that arise will be resolved by consulting a third author. The findings will subsequently be reported according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. ETHICS AND DISSEMINATION: Ethics approval is not required as secondary published data will be used. Our findings will be disseminated as peer-reviewed manuscripts, at conferences, student rounds and could be of interest to government health agencies and HIV/AIDS service organisations.

8.
Trop Med Int Health ; 26(5): 572-581, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33560587

RESUMO

OBJECTIVE: To explore experiences, preferences and engagement with HIV testing and prevention among urban refugee and displaced adolescents and youth in Kampala, Uganda, with a focus on the role of contextual factors in shaping access and uptake. METHODS: This qualitative community-based study with urban refugee and displaced youth aged 16-24 living in Kampala's informal settlements involved five focus groups (FG), including two with young women, two with young men, and one with sex workers from March to May 2019. We also conducted five in-depth key informant interviews. We conducted thematic analysis informed by Campbell and Cornish's conceptualisation of material and symbolic contexts. RESULTS: Refugee/displaced youth participants (n = 44; mean age: 20.25, SD: 2.19; men: n = 17; women: n = 27) were from the Democratic Republic of Congo (n = 29), Rwanda (n = 11), Burundi (n = 3) and Sudan (n = 1). Participant narratives reflected material and symbolic contexts that shaped HIV testing awareness, preferences and uptake. Material contextual factors that presented barriers to HIV testing and prevention engagement included transportation costs to clinics, overcrowded living conditions that limited access to private spaces, low literacy and language barriers. Symbolic contexts that constrained HIV testing engagement included medical mistrust of HIV testing and inequitable gender norms. Religion emerged as an opportunity to connect with refugee communities and to address conservative religious positions on HIV and sexual health. CONCLUSION: Efforts to increase access and uptake along the HIV testing and prevention cascade can meaningfully engage urban refugee and displaced youth to develop culturally and contextually relevant services to optimise HIV and sexual health outcomes.

9.
Thromb Res ; 201: 30-49, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33631520

RESUMO

INTRODUCTION: Oral anticoagulant (OAC) intervention trials have typically included clinical event outcomes. However, there is no standard list of outcomes to be used in OAC research. This study aimed to describe and classify the outcomes used in recent prospective clinical studies involving OACs. MATERIALS AND METHODS: We searched MEDLINE, EMBASE, and CINAHL databases from January 2009 to July 2019 for prospective studies with an intervention or control group that included one or more oral anticoagulants. We abstracted details about each included study and the outcomes used from the study report and its accompanying protocol. Using the Core Outcome Measures in Effectiveness Trials (COMET) Initiative recommendations, we categorised each outcome into one of five domains (mortality/survival, physiological/clinical, life impact, resource use, and adverse events). Our primary outcome was the prevalence of use of an outcome domain across studies. RESULTS: We included 70 prospective studies, including 52 randomized controlled trials and 18 prospective cohort studies. A total of 121 different outcomes were reported. The COMET domains were represented in the 70 studies as follows: mortality (63/70, 90.0%); physiological/clinical domain (70/70, 100%), life impact domain (43/70, 61.4%), resource use domain (26/70, 37.1%), and adverse events domain (55/70, 78.6%). CONCLUSION: Outcome reporting in prospective studies of OACs more frequently concentrates on mortality, physiological/clinical domains, and adverse events compared to life impact and resource utilization domains, the latter uncommonly used. A priority for future research includes developing a core outcome set (COS) for OAC research that represents all domains.

10.
JMIR Res Protoc ; 10(2): e26192, 2021 Feb 02.
Artigo em Inglês | MEDLINE | ID: mdl-33528378

RESUMO

BACKGROUND: HIV is the leading cause of mortality among youth in sub-Saharan Africa. Uganda hosts over 1.43 million refugees, and more than 83,000 live in Kampala, largely in informal settlements. There is limited information about HIV testing uptake and preferences among urban refugee and displaced youth. HIV self-testing is a promising method for increasing testing uptake. Further, mobile health (mHealth) interventions have been effective in increasing HIV testing uptake and could be particularly useful among youth. OBJECTIVE: This study aims to evaluate the feasibility and effectiveness of two HIV self-testing implementation strategies (HIV self-testing intervention alone and HIV self-testing combined with an mHealth intervention) in comparison with the HIV testing standard of care in terms of HIV testing outcomes among refugee/displaced youth aged 16 to 24 years in Kampala, Uganda. METHODS: A three-arm cluster randomized controlled trial will be implemented across five informal settlements grouped into three sites, based on proximity, and randomization will be performed with a 1:1:1 method. Approximately 450 adolescents (150 per cluster) will be enrolled and followed for 12 months. Data will be collected at the following three time points: baseline enrollment, 8 months after enrollment, and 12 months after enrollment. Primary outcomes (HIV testing frequency, HIV status knowledge, linkage to confirmatory testing, and linkage to HIV care) and secondary outcomes (depression, condom use efficacy, consistent condom use, sexual relationship power, HIV stigma, and adolescent sexual and reproductive health stigma) will be evaluated. RESULTS: The study has been conducted in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines. The study has received ethical approval from the University of Toronto (June 14, 2019), Mildmay Uganda (November 11, 2019), and the Uganda National Council for Science and Technology (August 3, 2020). The Tushirikiane trial launched in February 2020, recruiting a total of 452 participants. Data collection was paused for 8 months due to COVID-19. Data collection for wave 2 resumed in November 2020, and as of December 10, 2020, a total of 295 participants have been followed-up. The third, and final, wave of data collection will be conducted between February and March 2021. CONCLUSIONS: This study will contribute to the knowledge of differentiated HIV testing implementation strategies for urban refugee and displaced youth living in informal settlements. We will share the findings in peer-reviewed manuscripts and conference presentations. TRIAL REGISTRATION: ClinicalTrials.gov NCT04504097; https://clinicaltrials.gov/ct2/show/NCT04504097. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26192.

11.
CMAJ Open ; 9(1): E44-E52, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33436455

RESUMO

BACKGROUND: Health interventions and policies for high-cost health care users (HCUs) who are older adults need to be informed by a better understanding of their multimorbidity and medication use. This study aims to determine the financial contribution of medications to HCU expenditures and explore whether potentially inappropriate prescribing is associated with incident HCU development. METHODS: This is a protocol for a retrospective population-based matched cohort analysis of incident older adult HCUs (those with the highest 5% of costs and 66 years of age or older) in Ontario during fiscal year 2013. We will obtain person-level data for the index year and year before HCU status from health administrative databases and match each HCU to 3 non-HCUs based on age, sex and geographic location. Average annual medication costs (per patient) and the ratio of medication to total health care costs (at population level) will be examined over the HCU transition period and compared with non-HCUs. We will explore potential quality improvement areas for prescribing by analyzing chronic conditions and the use of medications with a strong evidence base for either clinical benefit or risk of harms outweighing benefits in older adults with these diagnoses. The relation between these medication classes and incident HCU status will be explored using logistic regression. INTERPRETATION: Using a matched cohort design and focusing on incident rather than prevalent HCUs, this protocol will explore our hypotheses that medications and the quality of their prescribing may be important triggers of HCU status and facilitate the identification of potential preventive clinical interventions or policies. Dissemination of results will occur via publications in peer-reviewed journals, presentations at conferences and academic settings, and knowledge translation activities with relevant health system and patient stakeholder groups. STUDY REGISTRATION: Clinicaltrials.gov, no. NCT02815930.

12.
Pilot Feasibility Stud ; 6(1): 164, 2020 Oct 29.
Artigo em Inglês | MEDLINE | ID: mdl-33292715

RESUMO

BACKGROUND: Pilot trials often use quantitative data such as recruitment rate and retention rate to inform the design and feasibility of a larger trial. However, qualitative data such as patient, healthcare provider, and research staff perceptions of an intervention may also provide insights for a larger trial. METHODS: As part of a larger study investigating the reporting of progression criteria in pilot studies, we sought to determine how often pilot studies planned to use qualitative data to inform the design and feasibility of a larger trial and the factors associated with plans to use qualitative data. We searched for protocols of pilot studies of randomized trials in PubMed between 2013 and 2017. RESULTS: We included 227 articles. Only 92 (40.5%; 95% confidence interval [CI] 34.1-47.2) reported plans to collect qualitative data. The factors associated with collecting qualitative data were large studies (defined as sample size ≥ 60; adjusted odds ratio [aOR] 2.77; 95% CI 1.47-5.23; p = 0.002) and studies from Europe (aOR 3.86; 95% CI 1.68-8.88; p = 0.001) compared to North America and the rest of the world. Pilot trials with pharmacological interventions were less likely to plan to collect qualitative data (aOR 0.20; 95% CI 0.07-0.58; p = 0.003). CONCLUSIONS: Qualitative data is not used enough in pilot trials. Large pilot trials, pilot trials from Europe, and pilot trials of non-pharmacological interventions are more likely to plan for qualitative data.

13.
BMJ Open ; 10(12): e040478, 2020 12 17.
Artigo em Inglês | MEDLINE | ID: mdl-33334836

RESUMO

INTRODUCTION: Methodological studies (ie, studies that evaluate the design, conduct, analysis or reporting of other studies in health research) address various facets of health research including, for instance, data collection techniques, differences in approaches to analyses, reporting quality, adherence to guidelines or publication bias. As a result, methodological studies can help to identify knowledge gaps in the methodology of health research and strategies for improvement in research practices. Differences in methodological study names and a lack of reporting guidance contribute to lack of comparability across studies and difficulties in identifying relevant previous methodological studies. This paper outlines the methods we will use to develop an evidence-based tool-the MethodologIcal STudy reportIng Checklist-to harmonise naming conventions and improve the reporting of methodological studies. METHODS AND ANALYSIS: We will search for methodological studies in the Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Embase, MEDLINE, Web of Science, check reference lists and contact experts in the field. We will extract and summarise data on the study names, design and reporting features of the included methodological studies. Consensus on study terms and recommended reporting items will be achieved via video conference meetings with a panel of experts including researchers who have published methodological studies. ETHICS AND DISSEMINATION: The consensus study has been exempt from ethics review by the Hamilton Integrated Research Ethics Board. The results of the review and the reporting guideline will be disseminated in stakeholder meetings, conferences, peer-reviewed publications, in requests to journal editors (to endorse or make the guideline a requirement for authors), and on the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network and reporting guideline websites. REGISTRATION: We have registered the development of the reporting guideline with the EQUATOR Network and publicly posted this project on the Open Science Framework (www.osf.io/9hgbq).


Assuntos
Lista de Checagem , Projetos de Pesquisa , Consenso , Humanos , Publicações
14.
J Int AIDS Soc ; 23(12): e25656, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33369131

RESUMO

INTRODUCTION: WHO's 2019 report on HIV drug resistance (HIVDR) documents a high prevalence of pretreatment drug resistance (PDR) among populations initiating first-line antiretroviral therapy (ART) in low- and middle-income countries (LMIC). However, systematic evidence on the prevalence of PDR among key populations remains limited. We performed a systematic review to characterize levels of PDR in key population groups and compared them to levels of PDR in the "general population" across different geographical regions. METHODS: Ten electronic databases were searched for papers published until February 2019 that included predefined search terms. We included studies that reported the number of successfully tested genotypes and the number of genotypes with drug resistance mutations among antiretroviral therapy treatment naïve people, recently infected people, or people initiating first-line ART from key populations. To assess the prevalence of PDR for each key population, we pooled estimates using random-effects meta-analysis of proportions. Where possible, we computed the differences in the odds of PDR (any, and by drug class) present in each key population compared to the "general population". The I2 statistic (a measure of heterogeneity between studies) is reported. RESULTS AND DISCUSSION: A total of 332 datasets (from 218 studies) and 63,111 people with successful HIVDR genotyping were included in the analysis. The pooled prevalence estimate of any PDR was high among men who have sex with men (13.0%, 95% CI 11.0 to 14.0%, I2  = 93.19), sex workers (17.0%, 95% CI 6.0 - 32.0, I2  = 87.31%) and people in prisons (18.0%, 95% CI 11.0 to 25.0, I2  = 70.18%), but less so among people who inject drugs (7.0%, 95% CI 5.0 to 10.0, I2  = 90.23). Overall, men who have sex with men were more likely to carry any PDR compared to the "general population," a finding which was statistically significant (odds ratio (OR) 1.28, 95% CI 1.13 - 1.46, I2 48.9%). CONCLUSIONS: High prevalence of PDR found in key populations highlights the need to increase access to effective first-line HIV treatment. The low prevalence of nucleotide reverse transcriptase inhibitor (NRTI) PDR suggests that current WHO recommendations for pre-exposure prophylaxis (PrEP) regimens will remain effective and can be scaled up to prevent new HIV infections in high-risk groups.

15.
Trials ; 21(1): 941, 2020 Nov 23.
Artigo em Inglês | MEDLINE | ID: mdl-33225995

RESUMO

OBJECTIVES: 1. To compare the effectiveness of four different surveillance strategies in detecting COVID-19 within the homeless shelter population. 2. To assess the participant adherence over time for each surveillance method. TRIAL DESIGN: This is a prospective cluster-randomized study to compare the effectiveness of four different surveillance regimens across eight homeless shelters in the city of Hamilton. PARTICIPANTS: Participants will include both residents of, and the staff working within, the homeless shelters. All participants aged 18 or older who consent to the study and are able to collect a swab sample (where relevant) are eligible for the study. The study will take place across eight homeless shelters (four men-only and four women-only) in the City of Hamilton in Ontario, Canada. INTERVENTION AND COMPARATOR GROUPS: The comparator group will receive active daily surveillance of symptoms and testing will only be completed in symptomatic participants (i.e. those who fail screening or who seek care for potential COVID-19 related symptoms). The three intervention arms will all receive active daily surveillance of symptoms and testing of symptomatic participants (as in the comparator group) in addition to one of the following: 1. Once weekly self-collected oral swabs (OS) regardless of symptoms using written and visual instructions. 2. Once weekly self-collected oral-nares swab (O-NS) regardless of symptoms using written and visual instructions. 3. Once weekly nurse collected nasopharyngeal swab (NPS) regardless of symptoms. Participants will follow verbal and written instructions for the collection of OS and O-NS specimens. For OS collection, participants are instructed to first moisten the swab on their tongue, insert the swab between the cheek and the lower gums and rotate the swab three times. This is repeated on the other side. For O-NS collection, after oral collection, the swab is inserted comfortably (about 2-3 cm) into one nostril, parallel to the floor and turned three times, then repeated in the other nostril. NPS specimens were collected by the nurse following standard of care procedure. All swabs were placed into a viral inactivation medium and transported to the laboratory for COVID-19 testing. Briefly, total nucleic acid was extracted from specimens and then amplified by RT-PCR for the UTR and Envelope genes of SARS-CoV-2 and the human RNase P gene, which is used as a sample adequacy marker. MAIN OUTCOMES: 1. PRIMARY OUTCOME: COVID-19 detection rate, i.e. the number of new positive cases over the study period of 8 weeks in each arm of the study. 2. SECONDARY OUTCOMES: Qualitative assessment of study enrollment over 8 weeks. Percentage of participants who performed 50% or more of the weekly swabs in the intervention arms in the 8 week study period. RANDOMIZATION: We will use a computer-generated random assignment list to randomize the shelters to one of four interventions. Shelters were stratified by gender, and the simple randomization scheme was applied within each stratum. The randomization scheme was created using WinPEPI. BLINDING: This is an open-label study in which neither participants nor assessors are blinded. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): Since we are including our total sample frame, a sample size estimation at the cluster level is not required. However, if we succeed to enroll 50 participants per shelter from 8 shelters (n=400), and the detection rate is 3 times higher in the intervention groups (0.15) than in the comparator groups (0.05), we will have 90% power to detect a statistically significant and clinically important difference at a type I error rate of alpha=0.05 (one tailed), assuming an intraclass correlation of ~0.008. These computations were done using WinPEPI, and informed by conservative estimates from other studies on respiratory illness in the homeless (see Full protocol). TRIAL STATUS: The protocol version number is 3.0. Recruitment began on April 17, 2020 and is ongoing. Due to low numbers of COVID cases in the community and shelter system during the initial study period, the trial was extended. The estimated date for the end of the extended recruitment period is Feb 1, 2021. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov on June 18, 2020 with the identifier NCT04438070 . FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Assuntos
Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/prevenção & controle , Pessoas em Situação de Rua/estatística & dados numéricos , Programas de Rastreamento/métodos , Pandemias/prevenção & controle , Pneumonia Viral/diagnóstico , Pneumonia Viral/prevenção & controle , Adulto , Betacoronavirus/genética , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/virologia , Diagnóstico Precoce , Feminino , Humanos , Masculino , Ontário/epidemiologia , Cooperação do Paciente , Pneumonia Viral/epidemiologia , Pneumonia Viral/virologia , Avaliação de Programas e Projetos de Saúde , Estudos Prospectivos , Manejo de Espécimes/métodos , Fatores de Tempo
16.
Syst Rev ; 9(1): 261, 2020 Nov 14.
Artigo em Inglês | MEDLINE | ID: mdl-33189147

RESUMO

BACKGROUND: Early identification of patients at risk for postoperative delirium is essential because adequate well-timed interventions could reduce the occurrence of delirium and the related detrimental outcomes. METHODS: We will conduct a systematic review and individual patient data (IPD) meta-analysis of prognostic studies evaluating the predictive value of risk factors associated with an increased risk of postoperative delirium in elderly patients undergoing elective surgery. We will identify eligible studies through systematic search of MEDLINE, EMBASE, and CINAHL from their inception to May 2020. Eligible studies will enroll older adults (≥ 50 years) undergoing elective surgery and assess pre-operative prognostic risk factors for delirium and incidence of delirium measured by a trained individual using a validated delirium assessment tool. Pairs of reviewers will, independently and in duplicate, screen titles and abstracts of identified citations, review the full texts of potentially eligible studies. We will contact chief investigators of eligible studies requesting to share the IPD to a secured repository. We will use one-stage approach for IPD meta-analysis and will assess certainty of evidence using the GRADE approach. DISCUSSION: Since we are using existing anonymized data, ethical approval is not required for this study. Our results can be used to guide clinical decisions about the most efficient way to prevent postoperative delirium in elderly patients. SYSTEMATIC REVIEW REGISTRATION: CRD42020171366 .

17.
J Infect Dis ; 2020 Nov 17.
Artigo em Inglês | MEDLINE | ID: mdl-33202025

RESUMO

BACKGROUND: Increased access to antiretroviral therapy (ART) has resulted in rising levels of pretreatment human immunodeficiency virus drug resistance (PDR). This is the first systematic review and meta-analysis to assess the impact of PDR on treatment outcomes among people initiating nonnucleoside reverse transcriptase inhibitor (NNRTI)-based ART, including the combination of efavirenz (EFV), tenofovir (TDF), and lamivudine or emtricitabine (XTC). METHODS: We systematically reviewed studies and conference proceedings comparing treatment outcomes in populations initiating NNRTI-based ART with and without PDR. We conducted subgroup analyses by regimen: (1) NNRTIs + 2 nucleoside reverse transcriptase inhibitors (NRTIs), (2) EFV + 2 NRTIs, or (3) EFV/TDF/XTC; by population (children vs adults); and by definition of resistance (PDR vs NNRTI PDR). RESULTS: Among 6197 studies screened, 32 were analyzed (31 441 patients). We found that individuals with PDR initiating NNRTIs across all the subgroups had increased risk of virological failure compared to those without PDR. Risk of acquisition of new resistance mutations and ART switch was also higher in people with PDR. CONCLUSIONS: This review shows poorer treatment outcomes in the presence of PDR, supporting the World Health Organization's recommendation to avoid using NNRTIs in countries where levels of PDR are high.

18.
JMIR Cardio ; 4(1): e15885, 2020 Nov 09.
Artigo em Inglês | MEDLINE | ID: mdl-33164901

RESUMO

BACKGROUND: Heart failure (HF) affects many older individuals in North America, with recurrent hospitalizations despite postdischarge strategies to prevent readmission. Proper HF self-care can potentially lead to better clinical outcomes, yet many older patients find self-care challenging. Mobile health (mHealth) apps can provide support to patients with respect to HF self-care. However, many mHealth apps are not designed to consider potential patient barriers, such as literacy, numeracy, and cognitive impairment, leading to challenges for older patients. We previously demonstrated that a paper-based standardized diuretic decision support tool (SDDST) with daily weights and adjustment of diuretic dose led to improved self-care. OBJECTIVE: The aim of this study is to better understand the self-care challenges that older patients with HF and their informal care providers (CPs) face on a daily basis, leading to the conversion of the SDDST into a user-centered mHealth app. METHODS: We recruited 14 patients (male: 8/14, 57%) with a confirmed diagnosis of HF, aged ≥60 years, and 7 CPs from the HF clinic and the cardiology ward at the Hamilton General Hospital. Patients were categorized into 3 groups based on the self-care heart failure index: patients with adequate self-care, patients with inadequate self-care without a CP, or patients with inadequate self-care with a CP. We conducted semistructured interviews with patients and their CPs using persona-scenarios. Interviews were transcribed verbatim and analyzed for emerging themes using an inductive approach. RESULTS: Six themes were identified: usability of technology, communication, app customization, complexity of self-care, usefulness of HF-related information, and long-term use and cost. Many of the challenges patients and CPs reported involved their unfamiliarity with technology and the lack of incentive for its use. However, participants were supportive and more likely to actively use the HF app when informed of the intervention's inclusion of volunteer and nurse assistance. CONCLUSIONS: Patients with varying self-care adequacy levels were willing to use an mHealth app if it was simple in its functionality and user interface. To promote the adoption and usability of these tools, patients confirmed the need for researchers to engage with end users before developing an app. Findings from this study can be used to help inform the design of an mHealth app to ensure that it is adapted for the needs of older individuals with HF.

20.
Pan Afr Med J ; 37: 42, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33209169

RESUMO

Introduction: multidetector computed tomography (MDCT) is a widely used cross-sectional imaging modality despite increasing concerns about radiation exposure and overuse. The aim of this study was to describe the socio-demographic characteristics of MDCT users in an urban city in Cameroon and to assess the clinical indications for appropriateness. Methods: we conducted a survey of MDCT users and collected data on demographic attributes and socialization patterns, clinical indications for MDCT and time to obtain MDCT. MDCT appropriateness was assessed using the American College of Radiologists Appropriateness Criteria®. Frequencies, percentages, odds ratios and 95% confidence intervals were used to summarize the data. Results: with a response rate of 79%, 511 MDCT users were surveyed. The mean (standard deviation) age was 45(19) years and male to female sex ratio 1:1. Seventy-eight percent (95% confidence interval [CI]: 74-83%) of respondents reported not having any health insurance. Head scans accounted for 52% (95%CI: 47-56%) of all scans with trauma (19% [95%CI: 15-22%]), low back pain (18% [95%CI: 14-21%]) and suspected stroke (10% [95%CI: 7-13%]) being the most frequent indications. Sixteen percent (95%CI: 13-20%) of the scans were judged to be inappropriate. Predictors of MDCT appropriateness after multivariable logistic regression modeling were age (aOR=0.97; P=0.009; 95%CI=0.94-0.99), health insurance ownership (aOR=0.40; P=0.034; 95%CI=0.18-0.94) and being referred by non-specialist physicians (aOR=0.20; P<0.001; 95%CI=0.09-0.47). Conclusion: people from all social strata use MDCT, mostly appropriately and especially for head scans after trauma in this urban setting. However, the proportion of inappropriate studies was considerable suggesting the need for control measures.

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