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1.
Ann Intern Med ; 2021 Sep 14.
Artigo em Inglês | MEDLINE | ID: mdl-34516270

RESUMO

BACKGROUND: The long-term risk for major bleeding in patients receiving extended (beyond the initial 3 to 6 months) anticoagulant therapy for a first unprovoked venous thromboembolism (VTE) is uncertain. PURPOSE: To determine the incidence of major bleeding during extended anticoagulation of up to 5 years among patients with a first unprovoked VTE, overall, and in clinically important subgroups. DATA SOURCES: MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials from inception to 23 July 2021. STUDY SELECTION: Randomized controlled trials (RCTs) and prospective cohort studies reporting major bleeding among patients with a first unprovoked VTE who were to receive oral anticoagulation for a minimum of 6 additional months after completing at least 3 months of initial anticoagulant treatment. DATA EXTRACTION: Two reviewers independently abstracted data and assessed study quality. Unpublished data required for analyses were obtained from authors of included studies. DATA SYNTHESIS: Among the 14 RCTs and 13 cohort studies included in the analysis, 9982 patients received a vitamin K antagonist (VKA) and 7220 received a direct oral anticoagulant (DOAC). The incidence of major bleeding per 100 person-years was 1.74 events (95% CI, 1.34 to 2.20 events) with VKAs and 1.12 events (CI, 0.72 to 1.62 events) with DOACs. The 5-year cumulative incidence of major bleeding with VKAs was 6.3% (CI, 3.6% to 10.0%). Among patients receiving either a VKA or a DOAC, the incidence of major bleeding was statistically significantly higher among those who were older than 65 years or had creatinine clearance less than 50 mL/min, a history of bleeding, concomitant use of antiplatelet therapy, or a hemoglobin level less than 100 g/L. The case-fatality rate of major bleeding was 8.3% (CI, 5.1% to 12.2%) with VKAs and 9.7% (CI, 3.2% to 19.2%) with DOACs. LIMITATION: Data were insufficient to estimate incidence of major bleeding beyond 1 year of extended anticoagulation with DOACs. CONCLUSION: In patients with a first unprovoked VTE, the long-term risks and consequences of anticoagulant-related major bleeding are considerable. This information will help inform patient prognosis and guide decision making about treatment duration for unprovoked VTE. PRIMARY FUNDING SOURCE: Canadian Institutes of Health Research. (PROSPERO: CRD42019128597).

2.
BMJ Open ; 11(9): e053004, 2021 09 07.
Artigo em Inglês | MEDLINE | ID: mdl-34493525

RESUMO

OBJECTIVES: To assess the effectiveness and cost-effectiveness of a single session compared with multiple sessions of education and exercise for older adults with spinal pain treated conservatively in an advanced practice physiotherapy model of care. METHODS AND ANALYSIS: In this pragmatic randomised controlled trial, 152 older adults (≥65 years old) with neck or back pain initially referred for a consultation in neurosurgery, but treated conservatively, will be recruited through the advanced practice physiotherapy neurosurgery CareAxis programme in the Montreal region (Quebec, Canada). In the CareAxis programme, older patients with spinal pain are triaged by an advance practice physiotherapist and are offered conservative care and only potential surgical candidates are referred to a neurosurgeon. Participants will be randomised into one of two arms: 1-a single session or 2-multiple sessions (6 sessions over 12 weeks) of education and exercise with the advance practice physiotherapist (1:1 ratio). The primary outcome measure will be the Brief Pain Inventory (pain severity and interference subscales). Secondary measures will include self-reported disability (the Neck Disability Index or Oswestry Disability Index), the Pain Catastrophizing Scale, satisfaction with care questionnaires (9-item Visit-specific Satisfaction Questionnaire and MedRisk), and the EQ-5D-5L. Participants' healthcare resources use and related costs will be measured. Outcomes will be collected at baseline and at 6, 12 and 26 weeks after enrolment. Intention-to-treat analyses will be performed, and repeated mixed-model analysis of variance will assess differences between treatment arms. Cost-utility analyses will be conducted from the perspective of the healthcare system. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Comité d'éthique de la recherche du CIUSS de l'Est-de-l'Île-de-Montréal (FWA00001935 and IRB00002087). Results of this study will be presented to different stakeholders, published in peer-reviewed journals and presented at international conferences. PROTOCOL VERSION: V.4 August 2021. TRIAL REGISTRATION NUMBER: NCT04868591; Pre-results.


Assuntos
Fisioterapeutas , Modalidades de Fisioterapia , Idoso , Análise Custo-Benefício , Exercício Físico , Humanos , Dor , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Inquéritos e Questionários
3.
Artigo em Inglês | MEDLINE | ID: mdl-34587539

RESUMO

OBJECTIVE: To systematically summarize evidence on the costs related to chronic pelvic pain (CPP) for women. DATA SOURCES: Electronic databases (MEDLINE, EMBASE, PubMed, and Cochrane Library) were searched from 1990 up until January 2021, and limited to only English and French studies. STUDY SELECTION: Of 1304 papers screened, 67 were screened in full-text, with a total of 13 studies included in final analysis. Studies focused on cost studies that estimated hospital cost or health system cost for pelvic pain, dysmenorrhea, dyspareunia, endometriosis with pain, interstitial cystitis or painful bladder syndrome were included. DATA EXTRACTION AND SYNTHESIS: A standardized data extraction form was created to extract study setting, design, and population, patient demographics, study duration, reported costs of chronic pelvic pain components and amounts. Two independent reviewers completed the data extraction and discrepancies were resolved through discussion with third reviewer available. CONCLUSION: Estimated healthcare costs ranged from $1,367 to $7,043 per woman per year (USD). The prescription costs ranged from $193 to $2,457 per woman per year. Indirect costs ranged from $4,216 to $12,789 per woman per year. Combined costs ranged from $1,820 to $20,898 per woman per year. The yearly costs of CPP varied according to the country; yearly costs were estimated to be $2.8 billion/year, ¥191,680 to ¥246,488 per woman per year, and $16,970 to $20,898 per woman per year in the US, Japan, and Australia respectively. The literature suggests that chronic pelvic pain represents a considerable economic burden on women and healthcare systems internationally, with indirect costs contributing a significant portion of total costs.

4.
BMJ Open ; 11(8): e046707, 2021 08 12.
Artigo em Inglês | MEDLINE | ID: mdl-34385243

RESUMO

INTRODUCTION: Chimeric antigen receptor T-cell (CAR-T) therapy is a class of immunotherapy. An economic evaluation conducted at an early stage of development of CAR-T therapy for treatment of adult relapsed or refractory acute lymphoblastic leukaemia could provide insight into factors contributing to the cost of treatment, the potential clinical benefits, and what the health system can afford. Traditionally, stakeholders are engaged in certain parts of health technology assessment processes, such as in the identification and selection of technologies, formulation of recommendations, and implementation of recommendations; however, little is known about processes for stakeholder engagement during the conduct of the assessment. This is especially the case for economic evaluations. Stakeholders, such as clinicians, policy-makers, patients, and their support networks, have insight into factors that can enhance the validity of an economic evaluation model. This research outlines a specific methodology for stakeholder engagement and represents an avenue to enhance health economic evaluations and support the use of these models to inform decision making for resource allocation. This protocol may inform a tailored framework for stakeholder engagement processes in future economic evaluation model development. METHODS AND ANALYSIS: We will involve clinicians, healthcare researchers, payers, and policy-makers, as well as patients and their support networks in the conduct and verification of an early economic evaluation of a novel health technology to incorporate stakeholder-generated knowledge. Three stakeholder-specific focus groups will be conducted using an online adaptation of the nominal group technique to elicit considerations from each. This study will use CAR-T therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukaemia as a basis for investigating broader stakeholder engagement processes. ETHICS AND DISSEMINATION: This study received ethics approval from the Ottawa Hospital Research Institute Research Ethics Board (REB 20200320-01HT) and the results will be shared via conference presentations, peer-reviewed publications, and ongoing stakeholder engagement.


Assuntos
Imunoterapia Adotiva , Receptores de Antígenos Quiméricos , Adulto , Terapia Baseada em Transplante de Células e Tecidos , Análise Custo-Benefício , Pessoal de Saúde , Humanos , Participação dos Interessados
5.
J Parkinsons Dis ; 2021 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-34366368

RESUMO

BACKGROUND: Parkinson's disease (PD) is a complex and debilitating condition that requires care from a multispecialty team. The Integrated Parkinson Care Network (IPCN) is an innovative pragmatic care model that focuses on integrated care, self-management support and technology-enabled care. OBJECTIVE: This study aims to estimate the costs of the IPCN and assess whether benefits gained from the intervention offset its costs based on a single center experience. METHODS: We conducted a return on investment (ROI) analysis of the IPCN from a societal perspective. The ROI for the IPCN was estimated as a ratio of the net savings and the intervention cost. The intervention cost was calculated as a sum of set-up and implementation costs. Cost savings was measured as the absolute reduction in the societal costs realized by PD patients. A positive ROI indicated that savings generated from the intervention offset its cost. RESULTS: The total cost of the IPCN for 100 PD patients was C$135,669, or C$226 per patient per month. IPCN was associated with the reduction in societal cost of C$915 per patient per month (95%CI: -2,782, 951). The ROI per PD patient per month for the IPCN was 3.08 (95%CI: -0.60, 22.93), suggesting that for every C$1 invested in the IPCN, C$4.08 is gained through reduction in societal costs. The returns were greater among advanced PD patients. CONCLUSION: The IPCN has the potential to offer a good return on investment for PD patients, and its value for money is higher among advanced PD patients.

6.
J Thromb Haemost ; 2021 Aug 11.
Artigo em Inglês | MEDLINE | ID: mdl-34379859

RESUMO

BACKGROUND: The long-term risk for recurrent venous thromboembolism (VTE) during extended anticoagulation for a first unprovoked VTE is uncertain. OBJECTIVES: To determine the incidence of recurrent VTE during extended anticoagulation of up to 5 years in patients with a first unprovoked VTE. METHODS: MEDLINE, EMBASE, and the Cochrane CENTRAL were searched to identify randomized trials and prospective cohort studies reporting recurrent VTE among patients with a first unprovoked VTE who were to receive anticoagulation for a minimum of six additional months after completing ≥3 months of initial treatment. Unpublished data on number of recurrent VTE and person-years, obtained from authors of included studies, were used to calculate study-level incidence rate, and random-effects meta-analysis was used to pool results. RESULTS: Twenty-six studies and 15 603 patients were included in the analysis. During 11 631 person-years of follow-up, the incidence of recurrent VTE and fatal pulmonary embolism per 100 person-years was 1.41 (95% CI, 1.03-1.84) and 0.09 (0.04-0.16), with 5-year cumulative incidences of 7.1% (3.0%-13.2%) and 1.2% (0.4%-4.6%), respectively. The incidence of recurrent VTE was 1.08 (95% CI, 0.77-1.44) with direct oral anticoagulants and 1.55 (1.01-2.20) with vitamin K antagonists. The case-fatality rate of recurrent VTE was 4.9% (95% CI, 2.2%-8.7%). CONCLUSIONS: In patients with a first unprovoked VTE, the long-term risk of recurrent VTE during extended anticoagulation is low but not negligible. Thus, clinicians and patients should be aware of this risk and take appropriate and timely action in case of suspicion of recurrent VTE. Estimates from this study can be used to advise patients on what to expect while receiving extended anticoagulation, and estimate the net clinical benefit of extended treatment to guide long-term management of unprovoked VTE.

7.
BMC Med Res Methodol ; 21(1): 179, 2021 08 28.
Artigo em Inglês | MEDLINE | ID: mdl-34454414

RESUMO

BACKGROUND: Since primary data collection can be time-consuming and expensive, surgical site infections (SSIs) could ideally be monitored using routinely collected administrative data. We derived and internally validated efficient algorithms to identify SSIs within 30 days after surgery with health administrative data, using Machine Learning algorithms. METHODS: All patients enrolled in the National Surgical Quality Improvement Program from the Ottawa Hospital were linked to administrative datasets in Ontario, Canada. Machine Learning approaches, including a Random Forests algorithm and the high-performance logistic regression, were used to derive parsimonious models to predict SSI status. Finally, a risk score methodology was used to transform the final models into the risk score system. The SSI risk models were validated in the validation datasets. RESULTS: Of 14,351 patients, 795 (5.5%) had an SSI. First, separate predictive models were built for three distinct administrative datasets. The final model, including hospitalization diagnostic, physician diagnostic and procedure codes, demonstrated excellent discrimination (C statistics, 0.91, 95% CI, 0.90-0.92) and calibration (Hosmer-Lemeshow χ2 statistics, 4.531, p = 0.402). CONCLUSION: We demonstrated that health administrative data can be effectively used to identify SSIs. Machine learning algorithms have shown a high degree of accuracy in predicting postoperative SSIs and can integrate and utilize a large amount of administrative data. External validation of this model is required before it can be routinely used to identify SSIs.


Assuntos
Algoritmos , Infecção da Ferida Cirúrgica , Humanos , Modelos Logísticos , Ontário/epidemiologia , Fatores de Risco , Infecção da Ferida Cirúrgica/diagnóstico , Infecção da Ferida Cirúrgica/epidemiologia
8.
Curr Oncol ; 28(4): 2385-2398, 2021 06 25.
Artigo em Inglês | MEDLINE | ID: mdl-34202403

RESUMO

INTRODUCTION: Variable costs of different radiation treatment modalities have played an important factor in selecting the most appropriate treatment for patients with intermediate-risk prostate cancer. METHODS: Analysis using a Markov model was conducted to simulate 20-year disease trajectory, quality-adjusted life years (QALYs) and health system costs of a cohort of intermediate-risk prostate cancer patients with mean age of 60 years. Clinical outcomes on toxicity and disease recurrence were measured and a probabilistic sensitivity analysis was performed, varying input parameters simultaneously according to their distributions. RESULTS: Among the six radiation treatment modalities, including conventionally fractionated intensity-modulated radiation therapy (IMRT), hypofractionated IMRT, IMRT combined with high-dose-rate (HDR) brachytherapy, HDR brachytherapy monotherapy, low-dose-rate brachytherapy monotherapy, and stereotactic body radiotherapy (SBRT), SBRT was found to be more cost-effective when compared with LDR-b and other treatment modalities, resulting in an incremental cost-utility ratio of $2985 per QALY. CONCLUSIONS: Stereotactic body radiotherapy is the most cost-effective radiation treatment modality in treatment of intermediate-risk prostate cancer, while treatment toxicity and cost data are the key drivers of the cost-utility. Further work is required with long-term follow-up for SBRT.


Assuntos
Braquiterapia , Neoplasias da Próstata , Radioterapia de Intensidade Modulada , Análise Custo-Benefício , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia , Neoplasias da Próstata/radioterapia
9.
J Urban Health ; 98(4): 538-550, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34181179

RESUMO

The Ontario Integrated Supervised Injection Services cohort in Toronto, Canada (OiSIS-Toronto) is an open prospective cohort of people who inject drugs (PWID). OiSIS-Toronto was established to evaluate the impacts of supervised consumption services (SCS) integrated within three community health agencies on health status and service use. The cohort includes PWID who do and do not use SCS, recruited via self-referral, snowball sampling, and community/street outreach. From 5 November 2018 to 19 March 2020, we enrolled 701 eligible PWID aged 18+ who lived in Toronto. Participants complete interviewer-administered questionnaires at baseline and semi-annually thereafter and are asked to consent to linkages with provincial healthcare administrative databases (90.2% consented; of whom 82.4% were successfully linked) and SCS client databases. At baseline, 86.5% of participants (64.0% cisgender men, median ([IQR] age= 39 [33-49]) had used SCS in the previous 6 months, of whom most (69.7%) used SCS for <75% of their injections. A majority (56.8%) injected daily, and approximately half (48.0%) reported fentanyl as their most frequently injected drug. As of 23 April 2021, 291 (41.5%) participants had returned for follow-up. Administrative and self-report data are being used to (1) evaluate the impact of integrated SCS on healthcare use, uptake of community health agency services, and health outcomes; (2) identify barriers and facilitators to SCS use; and (3) identify potential enhancements to SCS delivery. Nested sub-studies include evaluation of "safer opioid supply" programs and impacts of COVID-19.


Assuntos
COVID-19 , Preparações Farmacêuticas , Abuso de Substâncias por Via Intravenosa , Adulto , Estudos de Coortes , Humanos , Masculino , Ontário/epidemiologia , Estudos Prospectivos , SARS-CoV-2 , Abuso de Substâncias por Via Intravenosa/epidemiologia
10.
J Am Med Dir Assoc ; 2021 Jun 23.
Artigo em Inglês | MEDLINE | ID: mdl-34174195

RESUMO

OBJECTIVES: To estimate the prevalence of probable delirium in long-term care (LTC) and complex continuing care (CCC) settings and to describe the resident characteristics associated with probable delirium. DESIGN: Population-based cross-sectional study using routinely collected administrative health data. SETTING AND PARTICIPANTS: All LTC and CCC residents in Ontario, Canada, assessed with the Resident Assessment Instrument-Minimum Dataset (RAI-MDS) assessment between July 1, 2016, and December 31, 2016 (LTC n=86,454, CCC n=10,217). METHODS: Probable delirium was identified via the delirium Clinical Assessment Protocol on the RAI-MDS assessment, which is triggered when individuals display at least 1 of 6 delirium symptoms that are of recent onset and different from their usual functioning. RAI-MDS assessments were linked to demographic and health services utilization databases to ascertain resident demographics and health status. Multivariable logistic regression was used to identify characteristics associated with probable delirium, with adjusted odds ratios (ORs) and 95% confidence intervals (CIs) reported. RESULTS: Delirium was probable in 3.6% of LTC residents and 16.5% of CCC patients. LTC patients displayed fewer delirium symptoms than CCC patients. The most common delirium symptom in LTC was periods of lethargy (44.6% of delirium cases); in CCC, it was mental function varying over the course of the day (63.5% of delirium cases). The odds of probable delirium varied across individual demographics and health characteristics, with increased health instability having the strongest association with the outcome in both care settings (LTC: OR 30.4, 95% CI 26.2-35.3; CCC: OR 21.0, 95% CI 16.7-26.5 for high vs low instability). CONCLUSIONS AND IMPLICATIONS: There were differences in the presentation and burden of delirium symptoms between LTC and CCC, potentially reflecting differences in delirium severity or symptom identification. Several risk factors for probable delirium in LTC and CCC were identified that may be amenable to interventions to prevent this highly distressing condition.

11.
JMIR Res Protoc ; 10(6): e24887, 2021 Jun 11.
Artigo em Inglês | MEDLINE | ID: mdl-34114962

RESUMO

BACKGROUND: Health behaviors such as physical inactivity, unhealthy eating, smoking tobacco, and alcohol use are leading risk factors for noncommunicable chronic diseases and play a central role in limiting health and life satisfaction. To date, however, health behaviors tend to be considered separately from one another, resulting in guidelines and interventions for healthy aging siloed by specific behaviors and often focused only on a given health behavior without considering the co-occurrence of family, social, work, and other behaviors of everyday life. OBJECTIVE: The aim of this study is to understand how behaviors cluster and how such clusters are associated with physical and mental health, life satisfaction, and health care utilization may provide opportunities to leverage this co-occurrence to develop and evaluate interventions to promote multiple health behavior changes. METHODS: Using cross-sectional baseline data from the Canadian Longitudinal Study on Aging, we will perform a predefined set of exploratory and hypothesis-generating analyses to examine the co-occurrence of health and everyday life behaviors. We will use agglomerative hierarchical cluster analysis to cluster individuals based on their behavioral tendencies. Multinomial logistic regression will then be used to model the relationships between clusters and demographic indicators, health care utilization, and general health and life satisfaction, and assess whether sex and age moderate these relationships. In addition, we will conduct network community detection analysis using the clique percolation algorithm to detect overlapping communities of behaviors based on the strength of relationships between variables. RESULTS: Baseline data for the Canadian Longitudinal Study on Aging were collected from 51,338 participants aged between 45 and 85 years. Data were collected between 2010 and 2015. Secondary data analysis for this project was approved by the Ottawa Health Science Network Research Ethics Board (protocol ID #20190506-01H). CONCLUSIONS: This study will help to inform the development of interventions tailored to subpopulations of adults (eg, physically inactive smokers) defined by the multiple behaviors that describe their everyday life experiences. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24887.

12.
Curr Oncol ; 28(3): 1847-1856, 2021 05 13.
Artigo em Inglês | MEDLINE | ID: mdl-34068083

RESUMO

A cost-utility analysis was performed based on the Rethinking Clinical Trials (REaCT) bone-targeted agents (BTA) clinical trial that compared 12-weekly (once every 12 weeks) (n = 130) versus 4-weekly (once every 4 weeks) (n = 133) BTA dosing for metastatic breast and castration-resistant prostate (CRPC) cancer. Using a decision tree model, we calculated treatment and symptomatic skeletal event (SSE) costs as well as quality-adjusted life-years (QALYs) for each treatment option. Deterministic and probabilistic sensitivity analyses were performed to assess the robustness of the study findings. The total cost of BTA treatment in Canadian dollars (C$) and estimated QALYs was C$8965.03 and 0.605 QALY in the 4-weekly group versus C$5669.95 and 0.612 QALY in the 12-weekly group, respectively. De-escalation from 4-weekly to 12-weekly BTA reduces cost (C$3293.75) and improves QALYs by 0.008 unit, suggesting that 12-weekly BTA dominates 4-weekly BTA in breast and CRPC patients with bone metastases. Sensitivity analysis suggests high levels of uncertainty in the cost-effectiveness findings. De-escalation of bone-targeted agents is cost-effective from the Canadian public payer's perspective.


Assuntos
Neoplasias Ósseas , Neoplasias de Próstata Resistentes à Castração , Neoplasias Ósseas/tratamento farmacológico , Canadá , Análise Custo-Benefício , Humanos , Masculino , Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Anos de Vida Ajustados por Qualidade de Vida
13.
Sci Rep ; 11(1): 10173, 2021 05 13.
Artigo em Inglês | MEDLINE | ID: mdl-33986414

RESUMO

To provide a contemporary global prevalence of mental health issues among the general population amid the coronavirus disease-2019 (COVID-19) pandemic. We searched electronic databases, preprint databases, grey literature, and unpublished studies from January 1, 2020, to June 16, 2020 (updated on July 11, 2020), with no language restrictions. Observational studies using validated measurement tools and reporting data on mental health issues among the general population were screened to identify all relevant studies. We have included information from 32 different countries and 398,771 participants. The pooled prevalence of mental health issues amid the COVID-19 pandemic varied widely across countries and regions and was higher than previous reports before the COVID-19 outbreak began. The global prevalence estimate was 28.0% for depression; 26.9% for anxiety; 24.1% for post-traumatic stress symptoms; 36.5% for stress; 50.0% for psychological distress; and 27.6% for sleep problems. Data are limited for other aspects of mental health issues. Our findings highlight the disparities between countries in terms of the poverty impacts of COVID-19, preparedness of countries to respond, and economic vulnerabilities that impact the prevalence of mental health problems. Research on the social and economic burden is needed to better manage mental health problems during and after epidemics or pandemics. Systematic review registration: PROSPERO CRD 42020177120.


Assuntos
COVID-19/epidemiologia , Saúde Mental , Ansiedade/epidemiologia , Depressão/epidemiologia , Humanos , Prevalência , SARS-CoV-2/isolamento & purificação , Transtornos do Sono-Vigília/epidemiologia , Transtornos de Estresse Pós-Traumáticos/epidemiologia , Estresse Psicológico/epidemiologia
14.
J Bone Joint Surg Am ; 103(16): 1499-1509, 2021 Aug 18.
Artigo em Inglês | MEDLINE | ID: mdl-33886522

RESUMO

BACKGROUND: Although outcome studies generally demonstrate the superiority of a total shoulder arthroplasty (TSA) over a hemiarthroplasty (HA), comparative cost-effectiveness has not been well studied. From a publicly funded health-care system's perspective, this study compared the costs and quality-adjusted life-years (QALYs) in patients who underwent TSA with those in patients who underwent HA. METHODS: We conducted a cost-utility analysis using a Markov model to simulate the costs and QALYs for patients undergoing either TSA or HA over a lifetime horizon to account for costs and medically important events over the patient lifetime. Subgroup analyses by age groups (≤50 or >50 years) were performed. A series of sensitivity analyses were performed to assess robustness of study findings. The results were presented in 2019 U.S. dollars. RESULTS: TSA was dominant as it was less costly ($115,785 compared with $118,501) and more effective (10.21 compared with 8.47 QALYs) than HA over a lifetime horizon. Changes to health utility values after TSA and HA had the largest impact on the cost-effectiveness findings. At a willingness-to-pay (WTP) threshold of $50,000 per QALY gained, HA was not found to be cost-effective. The probability that TSA was cost-effective was 100%. CONCLUSIONS: Based on a WTP of $50,000 per QALY gained, from the perspective of Canada's publicly funded health-care system, TSA was found to be cost-effective in all patients, including those ≤50 years of age, compared with HA. LEVEL OF EVIDENCE: Economic and Decision Analysis Level II. See Instructions for Authors for a complete description of levels of evidence.

16.
Breast ; 58: 42-49, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33901921

RESUMO

BACKGROUND: Primary febrile neutropenia (FN) prophylaxis with ciprofloxacin or granulocyte-colony stimulating factors (G-CSF) is recommended with docetaxel-cyclophosphamide (TC) chemotherapy for early-stage breast cancer (EBC). A pragmatic randomised trial compared the superiority of G-CSF to ciprofloxacin and a cost-utility analysis were conducted. METHODS: EBC patients receiving TC chemotherapy were randomised to ciprofloxacin or G-CSF. The primary outcome was a composite of FN and non-FN treatment-related hospitalisation. Secondary outcomes included; rates of FN, non-FN treatment-related hospitalisation, chemotherapy dose reductions/delays/discontinuations. Primary analysis was performed with the intention to treat population. Cost-utility analyses were conducted from the Canadian public payer perspective. RESULTS: 458 eligible patients were randomised: 228 to ciprofloxacin and 230 to G-CSF. For the primary endpoint there was non-statistically significant difference (Risk difference = -6.7%, 95%CI = -13.5%-0.1%, p = 0.061) between ciprofloxacin patients (46,20.2%) and G-CSF (31,13.5%). Patients receiving ciprofloxacin were more likely to experience FN (36/228, 15.8% vs 13/230, 5.7%) than patients receiving G-CSF (p < 0.001). Non-FN treatment-related hospitalisation occurred in 40/228 (17.5%) of ciprofloxacin patients vs 28/230 (12.2%) of G-CSF patients (p = 0.12). There were no differences in other secondary outcomes. G-CSF was associated with an incremental cost-effectiveness ratio of C$1,760,796 per one quality-adjusted life year gained. CONCLUSION: The primary endpoint of superiority of G-CSF over ciprofloxacin was not demonstrated. While there were reduced FN rates with G-CSF, there were no differences in chemotherapy dose delays/reductions or discontinuations. With the commonly used willingness to pay value of C$50,000/QALY, G-CSF use was not cost-effective compared to ciprofloxacin and deserves scrutiny from the payer perspective.

17.
Trials ; 22(1): 230, 2021 Mar 25.
Artigo em Inglês | MEDLINE | ID: mdl-33766105

RESUMO

BACKGROUND: Novel therapies often fail to reach the bedside due to low trial recruitment rates. Prior to conducting one of the first chimeric antigen receptor (CAR) T cell therapy trials in Canada, we used the Theoretical Domains Framework, a novel tool for identifying barriers and enablers to behavior change, to identify physician-related barriers and enablers to screening and recruiting patients for an early phase immunotherapy trial. METHODS: We conducted interviews with hematologists across Canada and used a directed content analysis to identify relevant domains reflecting the key factors that may affect screening and recruitment. RESULTS: In total, we interviewed 15 hematologists. Physicians expressed "cautious hope"; while expressing safety, feasibility, and screening criteria concerns, 14 out of 15 hematologists intended to screen for the trial (domains: knowledge, goals, beliefs about consequences, intentions). Physicians underscored the "challenging contexts," identifying resources, workload, forgetting, and patient wait times to receive CAR T cells as key practical barriers to screening (domains: environmental context and resources, memory, attention and decision-making, behavioral regulation). They also highlighted "variability in roles and procedures" that may lead to missed trial candidates (domain: social and professional role). Left unaddressed, these barriers may undermine trial recruitment. CONCLUSIONS: This study is among the first to use the Theoretical Domains Framework from the physician perspective to identify recruitment challenges to early phase trials and demonstrates the value of this approach for identifying barriers to screening and recruitment that may not otherwise have been elicited. This approach can optimize trial procedures and may serve to inform future promising early phase cancer therapy trials. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03765177 . Registered on December 5, 2018.


Assuntos
Médicos , Receptores de Antígenos Quiméricos , Canadá , Terapia Baseada em Transplante de Células e Tecidos , Humanos , Papel Profissional
18.
BMJ Open ; 11(3): e043929, 2021 03 19.
Artigo em Inglês | MEDLINE | ID: mdl-33741670

RESUMO

OBJECTIVES: Bench to bedside translation of groundbreaking treatments like chimeric antigen receptor T (CAR-T) cell therapy depends on patient participation in early phase trials. Unfortunately, many novel therapies fail to be adequately evaluated due to low recruitment rates, which slows patient access to emerging treatments. Using the Theoretical Domains Framework (TDF), we sought to identify potential patient barriers and enablers to participating in an early phase CAR-T cell therapy trial. DESIGN: We used qualitative semistructured interviews to identify potential barriers and enablers to patients' hypothetical participation in an early phase CAR-T cell therapy trial. We used the TDF and directed content analysis to identify relevant domains based on frequency, relevance and the presence of conflicting beliefs. PARTICIPANTS: Canadian adult patients diagnosed with haematological malignancies. RESULTS: In total, we interviewed 13 participants (8 women, 5 men). Participants ranged in age from 18 to 73 (median=56) and had been living with haematological cancer from a few months to several years. We found participants were unfamiliar with CAR-T cell therapy but wished to know more about treatment safety, efficacy and trial logistics (domains: knowledge, beliefs about consequences). They were motivated by altruistic considerations, though many prioritised personal health benefits despite recognising the goals (ie, establishing safety) of early phase clinical trials (domains: goals, intentions). Every participant valued receiving medical advice from their haematologists and oncologists, though some preferred impartial medical experts to inform their decision making (domain: social influences). Finally, participants indicated that improving access to financial and social supports would improve their trial participation experience (domain: environmental context and resources). CONCLUSION: Using the TDF allowed us to identify factors that might undermine participation to a CAR-T cell therapy trial and to optimise recruitment processes by considering patient perspectives to taking part in early phase trials.Trial regestration: NCT03765177; Pre-results.


Assuntos
Receptores de Antígenos Quiméricos , Adulto , Canadá , Terapia Baseada em Transplante de Células e Tecidos , Pré-Escolar , Feminino , Humanos , Masculino , Participação do Paciente , Incerteza
19.
J Med Internet Res ; 23(2): e25363, 2021 02 12.
Artigo em Inglês | MEDLINE | ID: mdl-33523828

RESUMO

BACKGROUND: The COVID-19 pandemic has had a negative impact on both the physical and mental health of individuals worldwide. Evidence regarding the association between mental health problems and information exposure among Thai citizens during the COVID-19 outbreak is limited. OBJECTIVE: This study aimed to explore the relationship between information exposure and mental health problems during the COVID-19 pandemic in Thailand. METHODS: Between April 21 and May 4, 2020, we conducted a cross-sectional, nationwide online survey of the general population in Thailand. We categorized the duration of exposure to COVID-19-related information as follows: <1 h/day (reference group), 1-2 h/day, and ≥3 h/day. Mental health outcomes were assessed using the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7 scale, the Perceived Stress Scale-10, and the Insomnia Severity Index for symptoms of depression, anxiety, perceived stress, and insomnia, respectively. Multivariable logistic regression models were used to evaluate the relationship between information exposure and the risk of developing the aforementioned symptoms. An ancillary analysis using multivariable multinomial logistic regression models was also conducted to assess the possible dose-response relationship across the severity strata of mental health problems. RESULTS: Of the 4322 eligible participants, 4004 (92.6%) completed the online survey. Of them, 1481 (37.0%), 1644 (41.1%), and 879 (22.0%) participants were exposed to COVID-19-related information for less than 1 hour per day, 1 to 2 hours per day, or 3 or more hours per day, respectively. The major source of information related to the COVID-19 pandemic was social media (95.3%), followed by traditional media (68.7%) and family members (34.9%). Those exposed to information for 3 or more hours per day had a higher risk of developing symptoms of depression (adjusted odds ratio [OR] 1.35, 95% CI 1.03-1.76; P=.03), anxiety (adjusted OR 1.88, 95% CI 1.43-2.46; P<.001), and insomnia (adjusted OR 1.52, 95% CI 1.17-1.97; P=.001) than people exposed to information for less than 1 hour per day. Meanwhile, people exposed to information for 1 to 2 hours per day were only at risk of developing symptoms of anxiety (adjusted OR 1.35, 95% CI 1.08-1.69; P=.008). However, no association was found between information exposure and the risk of perceived stress. In the ancillary analysis, a dose-response relationship was observed between information exposure of 3 or more hours per day and the severity of mental health problems. CONCLUSIONS: These findings suggest that social media is the main source of COVID-19-related information. Moreover, people who are exposed to information for 3 or more hours per day are more likely to develop psychological problems, including depression, anxiety, and insomnia. Longitudinal studies investigating the long-term effects of COVID-19-related information exposure on mental health are warranted.


Assuntos
Ansiedade/epidemiologia , COVID-19/epidemiologia , Depressão/epidemiologia , Educação em Saúde/estatística & dados numéricos , Uso da Internet/estatística & dados numéricos , Saúde Mental/estatística & dados numéricos , Distúrbios do Início e da Manutenção do Sono/epidemiologia , Estresse Psicológico/epidemiologia , Adulto , Estudos Transversais , Surtos de Doenças , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , Mídias Sociais/provisão & distribuição , Inquéritos e Questionários , Tailândia/epidemiologia
20.
Stem Cells Transl Med ; 10(7): 968-975, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33570257

RESUMO

Cell-based therapies hold promise to substantially curb complications from extreme preterm birth, the main cause of death in children below the age of 5 years. Exciting preclinical studies in experimental neonatal lung injury have provided the impetus for the initiation of early phase clinical trials in extreme preterm infants at risk of developing bronchopulmonary dysplasia. Clinical translation of promising therapies, however, is slow and often fails. In the adult population, results of clinical trials so far have not matched the enticing preclinical data. The neonatal field has experienced many hard-earned lessons with the implementation of oxygen therapy or postnatal steroids. Here we briefly summarize the preclinical data that have permitted the initiation of early phase clinical trials of cell-based therapies in extreme preterm infants and describe the INCuBAToR concept (Innovative Neonatal Cellular Therapy for Bronchopulmonary Dysplasia: Accelerating Translation of Research), an evidence-based approach to mitigate the risk of translating advanced therapies into this vulnerable patient population. The INCuBAToR addresses several of the shortcomings at the preclinical and the clinical stage that usually contribute to the failure of clinical translation through (a) systematic reviews of preclinical and clinical studies, (b) integrated knowledge transfer through engaging important stakeholders early on, (c) early economic evaluation to determine if a novel therapy is viable, and (d) retrospective and prospective studies to define and test ideal eligibility criteria to optimize clinical trial design. The INCuBAToR concept can be applied to any novel therapy in order to enhance the likelihood of success of clinical translation in a timely, transparent, rigorous, and evidence-based fashion.

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