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1.
BMJ Open Qual ; 13(3)2024 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-38955396

RESUMO

Ambulatory management of congestive heart failure (HF) continues to be a challenging clinical problem. Recent studies have focused on the role of HF clinics, nurse practitioners and disease management programmes to reduce HF readmissions. This pilot study is a pragmatic factorial study comparing a coach intervention, a SMARTPHONE REMINDER system intervention and BOTH interventions combined to Treatment as USUAL (TAU). We determined that both modalities were acceptable to patients prior to randomisation. Fifty-four patients were randomised to the four groups. The COACH group had no readmissions for HF 6 months after enrolment compared with 18% for the SMARTPHONE REMINDER Group, 8% for the BOTH intervention group and 13% for TAU. Medium-to-high medication adherence was maintained in all four groups although sodium consumption was lower at 3 months for the COACH and combined (BOTH) groups. This pilot study suggests a beneficial effect on rehospitalisation with the use of support measures including coaches and telephone reminders that needs confirmation in a larger trial.


Assuntos
Insuficiência Cardíaca , Sistemas de Alerta , Smartphone , Humanos , Insuficiência Cardíaca/terapia , Projetos Piloto , Masculino , Feminino , Sistemas de Alerta/estatística & dados numéricos , Sistemas de Alerta/instrumentação , Smartphone/estatística & dados numéricos , Idoso , Pessoa de Meia-Idade , Readmissão do Paciente/estatística & dados numéricos , Adesão à Medicação/estatística & dados numéricos
2.
Open Access Emerg Med ; 16: 101-105, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38706755

RESUMO

Sixth Disease (roseola infantum) and its primary causative agent, HHV-6, share names that numerically concur. This article examines and answers the question of whether that correspondence is by design or coincidental by briefly reviewing the history and nomenclature of the HHV viruses and the classic febrile rashes of childhood while highlighting some clinical and microbiologic features of HHV-6 infection.

3.
Ann Emerg Med ; 84(2): 139-153, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38795081

RESUMO

In the coming years, artificial intelligence (AI) and machine learning will likely give rise to profound changes in the field of emergency medicine, and medicine more broadly. This article discusses these anticipated changes in terms of 3 overlapping yet distinct stages of AI development. It reviews some fundamental concepts in AI and explores their relation to clinical practice, with a focus on emergency medicine. In addition, it describes some of the applications of AI in disease diagnosis, prognosis, and treatment, as well as some of the practical issues that they raise, the barriers to their implementation, and some of the legal and regulatory challenges they create.


Assuntos
Inteligência Artificial , Medicina de Emergência , Aprendizado de Máquina , Medicina de Emergência/tendências , Inteligência Artificial/tendências , Humanos , Aprendizado de Máquina/tendências , Previsões
5.
J Clin Med ; 12(23)2023 Nov 30.
Artigo em Inglês | MEDLINE | ID: mdl-38068476

RESUMO

BACKGROUND: Intra-articular hyaluronic acid (IAHA) products are often used in the treatment of adults with mild-to-moderate knee osteoarthritis (KOA). The International Symposium on Intra-Articular Treatment (ISIAT) convened a multidisciplinary technical expert panel to define characteristics for an innovative IAHA product that should answer unmet needs in the clinical management of adults with mild-to-moderate KOA. METHODS: An initial set of evidence-based statements was developed based on data extracted from articles identified through a comprehensive literature search. A Delphi panel comprising 19 experts in KOA voted in 3 rounds to rate their degree of agreement with accepted statements. RESULTS: The final set of 13 accepted statements focus on the effect of an innovative IAHA across 5 key domains of nociceptive pain, joint function, quality of life, joint structure and integrity, and adverse effects. The statements set thresholds for clinically meaningful improvements that exceed those generally achievable by currently available IAHA products. CONCLUSION: The characteristics described by these statements from the ISIAT set new standards for what should be expected from an innovative IAHA. These statements should serve as a framework for driving the development of innovative IAHA products that will surpass the actual outcomes achieved by current viscosupplements in patients with mild-to-moderate KOA.

6.
Sports Med Open ; 9(1): 67, 2023 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-37526793

RESUMO

Resistance training (RT) is one of the most effective interventions available to older adults wishing to slow the progressive loss of muscle size and strength known to occur with age. Less is known about the ability of RT to resist the onset of an equally problematic condition related to increased age: obesity. The objective of this scoping review was to characterize current research associated with RT and weight loss in older adults, including protocols, feasibility, and gaps in current knowledge. We searched six databases using variations of the terms "resistance training," "weight loss," and "older adults" for experimental or quasi-experimental studies published in the year 2009 or later. Studies were included if they featured at least one treatment group with a mean age of > 65 years that engaged in an RT-only exercise protocol with no aerobic or high-intensity interval component. Of the 6102 references identified by the initial database search, 24 were retained for analysis. Older women and older adults with obesity or sarcopenic obesity were the most studied groups (n = 13), followed by healthy community-dwelling older adults (n = 11) and studies involving older adults and some aspect of either dietary control or pharmaceutical intervention (n = 8). Significant between-study heterogeneity was observed in the RT characteristics researchers thought optimal for improving body composition measures in older adults. Changes in body composition, rather than total body mass, were found to be the essential variables to consider when evaluating the effectiveness of an RT intervention aimed at reducing chronic disease in older adults. Weight loss alone appears to be an incomplete and problematic outcome measure for older adults, with changes in body composition (ratio of fat mass to lean mass) being the more appropriate variable to emphasize in this population. However, it is important to note that only one study, showing questionably reproducible findings, found a significant lean body mass gain. The lack of abundant high-quality evidence demonstrating combined RT and a healthy diet can lead to significant fat loss and lean body mass gain, coupled with high attrition rates observed in many of the studies reviewed, highlight the need for further rigorous research.

7.
Postgrad Med J ; 99(1169): 207-210, 2023 May 19.
Artigo em Inglês | MEDLINE | ID: mdl-37222062

RESUMO

Physical inactivity is a leading risk factor for non-communicable diseases (NCDs) and early mortality. Family physicians have an important role in providing physical activity counselling to patients to help prevent and treat NCDs. Lack of training on physical activity counselling is a barrier in undergraduate medical education, yet little is known regarding physical activity teaching in postgraduate family medicine residency. We assessed the provision, content and future direction of physical activity teaching in Canadian postgraduate family medicine residency programs to address this data gap. Fewer than half of Canadian Family Medicine Residency Programme directors reported providing structured physical activity counselling education to residents. Most directors reported no imminent plans to change the content or amount of teaching. These results reflect significant gaps between the recommendations of WHO, which calls on doctors to prescribe physical activity, and the current curricular content and needs of family medicine residents. Almost all directors agreed that online educational resources developed to assist residents in physical activity prescription would be beneficial. By describing the provision, content and future direction of physical activity training in family medicine, physicians and medical educators can develop competencies and resources to meet this need. When we equip our future physicians with the necessary tools, we can improve patient outcomes and do our part to reduce the global epidemic of physical inactivity and chronic disease.


Assuntos
Medicina de Família e Comunidade , Doenças não Transmissíveis , Humanos , Canadá , Médicos de Família , Escolaridade , Exercício Físico
8.
PLoS One ; 18(5): e0285182, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37192189

RESUMO

PURPOSE: This is a study protocol to co-create with knowledge users a core outcome set focused on middle-aged and older adults (40 years+) for use in social prescribing research. METHODS: We will follow the Core Outcome Measures in Effectiveness Trials (COMET) guide and use modified Delphi methods, including collating outcomes reported in social prescribing publications, online surveys, and discussion with our team to finalize the core outcome set. We intentionally center this work on people who deliver and receive social prescribing and include methods to evaluate collaboration. Our three-part process includes: (1) identifying published systematic reviews on social prescribing for adults to extract reported outcomes; and (2) up to three rounds of online surveys to rate the importance of outcomes for social prescribing. For this part, we will invite people (n = 240) who represent the population experienced in social prescribing, including researchers, members of social prescribing organizations, and people who receive social prescribing and their caregivers. Finally, we will (3) convene a virtual team meeting to discuss and rank the findings and finalize the core outcome set and our knowledge mobilization plan. CONCLUSION: To our knowledge, this is the first study designed to use a modified Delphi method to co-create core outcomes for social prescribing. Development of a core outcome set contributes to improved knowledge synthesis via consistency in measures and terminology. We aim to develop guidance for future research, and specifically on the use of core outcomes for social prescribing at the person/patient, provider, program, and societal-level.


Assuntos
Avaliação de Resultados em Cuidados de Saúde , Projetos de Pesquisa , Humanos , Pessoa de Meia-Idade , Idoso , Resultado do Tratamento , Técnica Delphi , Consenso
9.
Contemp Clin Trials ; 129: 107178, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-37031793

RESUMO

BACKGROUND: Previous research highlights the need for effective lifestyle interventions for men. Hockey Fans in Training (Hockey FIT) was developed as a pragmatic healthy lifestyle program tailored to men with overweight or obesity. This paper overviews the rationale, program details, and design of a recently completed cluster randomized controlled trial (RCT) of Hockey FIT. Participant engagement and baseline characteristics are also described. METHODS: The RCT evaluated the effectiveness, cost-effectiveness, and implementation of Hockey FIT. Forty-two sites in Canada and the United States were randomized to either the Hockey FIT intervention group or wait-list control group. Participants were men, aged 35-65 years, with a body mass index (BMI) ≥27 kg/m2. Hockey FIT is a group-based, off-ice, in-person healthy lifestyle program, including both a 3-month active phase and a 9-month minimally-supported phase. Outcomes were assessed at baseline, 3, and 12 months. The primary outcome was weight loss at 12 months. RESULTS: The design of the cluster RCT incorporates evaluations of participant health outcomes, program implementation, and broader healthcare system impact. In the RCT, 1397 participants were assessed for eligibility and 997 were enrolled. Most participants heard about the program through social media or hockey team emails. Participants averaged 49 years of age, had BMI values of 35.3 kg/m2, were predominately white, and had varying levels of education. CONCLUSION: The intended audience for Hockey FIT was recruited successfully, however, targeted recruitment to better engage diverse populations is warranted. This paper affords a useful outline for evaluating future lifestyle interventions tailored to men. This trial was registered on August 17, 2018 with ClinicalTrials.gov (identifier: NCT03636282).


Assuntos
Hóquei , Sobrepeso , Masculino , Humanos , Feminino , Sobrepeso/terapia , Promoção da Saúde , Obesidade/terapia , Estilo de Vida Saudável
10.
Public Health ; 218: 197-207, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-37060740

RESUMO

OBJECTIVE: Social prescribing is a complex care model, which aims to address unmet non-medical needs and connect people to community resources. The purpose of this systematic review was to synthesize available evidence from qualitative methods (e.g. interviews or focus groups) on experience, outcomes, and processes for social prescribing and older adults (from the person or provider level). STUDY DESIGN: This was a systematic review using the Joanna Brigg's meta-aggregative approach. METHODS: We searched multiple online databases for peer-reviewed studies, which included older adults aged ≥60 years (group mean age) and social prescribing experience, outcomes, or processes. We included all qualitative or mixed methods designs from all years and languages. Date of the last primary search was March 24, 2022. Two authors used online software to conduct the screening independently and then decided on the final list of included studies via notes and online discussion. RESULTS: We screened 376 citations (after duplicates) and included eight publications. There were 197 older adult participants (59% women), and many people were living with chronic health conditions. Few details were provided for participants' ethnicity, education, and related factors. We created five synthesized findings related to (1) the approach of social prescribing; implementation factors such as (2) relationships, (3) behavior change strategies, and (4) the environment; and (5) older adults' perceived health and psychosocial outcomes. CONCLUSIONS: Despite the limited number of available studies, data provide an overview of people and processes involved with social prescribing, identified research and practice gaps, and possible next steps for implementing and evaluating social prescribing for older adults in primary care.


Assuntos
Grupos Focais , Interação Social , Idoso , Feminino , Humanos , Masculino
11.
Ther Adv Musculoskelet Dis ; 15: 1759720X221131604, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36860967

RESUMO

Background: Early stage of osteoarthritis (OA) is characterized by joint stiffness and pain as well as by subclinical structural changes that may affect cartilage, synovium, and bone. At the moment, the lack of a validated definition of early osteoarthritis (EOA) does not allow to make an early diagnosis and adopt a therapeutic strategy to slow disease progression. Also, no questionnaires are available to evaluate the early stage, and therefore this remains an unmet need. Objective: Therefore, the purpose of the technical experts panel (TEP) of 'International Symposium of intra-articular treatment' (ISIAT) was to create a specific questionnaire to evaluate and monitor the follow-up and clinical progress of patients affected by early knee OA. Design: The items for the Early Osteoarthritis Questionnaire (EOAQ) were identified according to the following steps: items generation, items reduction, and pre-test submission. Methods: During the first step, literature has been reviewed and a comprehensive list of items about pain and function in knee EOA was drafted. Then, during the ISIAT (5th edition 2019), the draft has been discussed by the board, which reformulated, deleted, or subdivided some of the items. After the ISIAT symposium, the draft was submitted to 24 subjects affected by knee OA. A score based on the importance and the frequency was created and the items with a score ⩾0.75 were selected. After intermediate evaluation made by a sample of patients, the second and final version of the questionnaire EOAQ was submitted to the whole board for final analysis and acceptance in a second meeting (29 January 2021). Results: After an exhaustive elaboration, the final version of the questionnaire contains two domains (Clinical Features and Patients Reported Outcome) with respectively 2 and 9 questions, for a total of 11 questions. Questions mainly explored the fields of early symptoms and patients reported outcomes. Marginally, the need of the symptoms treatment and the use of painkillers were investigated. Conclusions: Adoption of diagnostic criteria of early OA is strongly encouraged and a specific questionnaire for the whole management of the clinical features and patients' outcome might really improve the evolution of OA in the early stages of the disease, when the treatment is expected to be more effective.

12.
Can J Diabetes ; 47(3): 250-256, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-36858923

RESUMO

OBJECTIVES: Type 2 diabetes is associated with deficits in cognition and brain health. Individuals with at least 1 risk factor for diabetes (i.e. obesity, prediabetes) already experience some neurocognitive impairment and are at risk for further decline. One way to combat these deficits is through exercise, but it is unknown whether resistance exercise can improve these functions in this at-risk group. METHODS: This study was a pilot randomized controlled trial. Participants were 60 to 80 years of age and had prediabetes (fasting capillary glucose 6.1 to 6.9 mmol/L) and/or were living with overweight or obesity (body mass index ≥25 kg/m2). Participants completed resistance training or balance and stretching exercises (control) thrice weekly for 6 months. Neuropsychological tests were used to assess cognitive ability, whereas functional magnetic resonance imaging was used to examine brain activation patterns. RESULTS: Resistance training led to improvements in task-switching, attention, and conflict resolution, as well as improved patterns of brain activation that may mimic healthy older adults. CONCLUSIONS: Resistance exercise may serve as an effective behavioural strategy to improve neurocognition in older adults at risk for type 2 diabetes. A large-scale powered trial is needed to further explore these findings.


Assuntos
Diabetes Mellitus Tipo 2 , Estado Pré-Diabético , Treinamento Resistido , Humanos , Idoso , Estado Pré-Diabético/terapia , Projetos Piloto , Cognição/fisiologia , Terapia por Exercício/métodos , Encéfalo/diagnóstico por imagem , Obesidade
13.
JMIR Form Res ; 6(11): e30285, 2022 Nov 25.
Artigo em Inglês | MEDLINE | ID: mdl-36427239

RESUMO

BACKGROUND: Data attrition has been a common problem in longitudinal lifestyle interventions. The contributors to attrition in technology-supported physical activity interventions have not been thoroughly studied. OBJECTIVE: The present study examined the roles of personality characteristics and indicators of psychological well-being in data attrition within a technology-supported, longitudinal intervention study with overweight adults. METHODS: Participants (N=89) were adults from the Motivation Makes the Move! intervention study. Data attrition was studied after a 3-month follow-up. Participants' personality characteristics were studied using the Short Five self-report questionnaire. Psychological well-being indicators were assessed with the RAND 36-item health survey, Positive and Negative Affect Schedule, and Beck Depression Inventory. Logistic regression analyses were conducted to assess the risk of discontinuing the study. The analyses were adjusted for sex, age, study group, and educational status. RESULTS: At the 3-month follow-up, 65 of 89 participants (73% of the initial sample) had continued in the study. Participants' personality characteristics and indicators of psychological well-being were not associated with the risk of dropping out of the study (all P values >.05). The results remained the same after covariate controls. CONCLUSIONS: Participant attrition was not attributable to personality characteristics or psychological well-being in the Motivation Makes the Move! study conducted with overweight adults. As attrition remains a challenge within longitudinal, technology-supported lifestyle interventions, attention should be paid to the potentially dynamic natures of personality and psychological well-being, as well as other elements beyond these. TRIAL REGISTRATION: ClinicalTrials.gov NCT02686502; https://clinicaltrials.gov/ct2/show/NCT02686502.

14.
Fam Med Community Health ; 10(Suppl 1)2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-36207017

RESUMO

OBJECTIVE: Social prescribing is a person-centred model of care with emphases on lessening the impact of unmet social needs, supporting the delivery of personalised care, and reducing non-medical resource use in the primary care setting. The purpose of this systematic review was to synthesise the effect of social prescribing for older adults within primary care. DESIGN: We followed standard systematic review guidelines, including protocol registration, screening studies (title/abstract and full text) and assessing the study quality. ELIGIBILITY AND INFORMATION SOURCES: We searched multiple online databases for studies that included older adults 60+ years (group mean age), an intervention defined and called social prescribing (or social prescription) via health provider referrals to non-medical services, and quantitative physical and psychosocial outcomes and/or health resource use. We included experimental and observational studies from all years and languages and conducted a narrative synthesis. The date of the last search was 24 March 2022. RESULTS: We screened 406 citations (after removing duplicates) and included seven studies. All studies except one were before-after design without a control group, and all except one study was conducted in the UK. Studies included 12-159 participants (baseline), there were more women than men, the group mean (SD) age was 76.1 (4.0) years and data collection (baseline to final) occurred on average 19.4 (14.0) weeks apart. Social prescribing referrals came from health and social providers. Studies had considerable risk of bias, programme implementation details were missing, and for studies that reported data (n=6) on average only 66% of participants completed studies (per-protocol). There were some positive effects of social prescribing on physical and psychosocial outcomes (eg, social participation, well-being). Findings varied for health resource use. These results may change with new evidence. CONCLUSIONS: There were few peer-reviewed studies available for social prescribing and older adults. Next steps for social prescribing should include co-creating initiatives with providers, older people and communities to identify meaningful outcomes, and feasible and robust methods for uptake of the prescription and community programmes. This should be considered in advance or in parallel with determining its effectiveness for meaningful outcomes at multiple levels (person, provider and programme).


Assuntos
Atenção Primária à Saúde , Apoio Social , Idoso , Feminino , Humanos , Masculino
15.
BMJ Open Sport Exerc Med ; 8(3): e001373, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35999822

RESUMO

Objectives: To identify how primary care physicians (PCPs) prescribe physical activity for patients with chronic disease, and to determine characteristics of physical activity interventions with improved clinical outcomes of chronic disease. Design: A scoping review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews 2018 was completed. Data sources: Four bibliographic databases (Medline, EMBASE, SPORTDiscus, CINAHL) and four grey literature/unpublished databases (Proquest, National Institute for Health and Care Excellence, Canadian Health Research Collections, Clinical Trials) were searched from inception to 7 March 2022. Eligibility criteria for selecting studies: Studies involving PCP-delivered physical activity prescriptions or counselling for participants with a chronic disease or mental health condition, which reported clinical outcomes were included. Opinion papers, news and magazine articles and case reports were excluded, as were studies in which a physical activity intervention was provided for primary prevention of chronic disease, prescribed by healthcare providers or researchers other than PCPs, or for healthy participants without chronic disease. Results: An initial search identified 4992 records. Fifteen studies met inclusion criteria. Characteristics of physical activity prescriptions that improved clinical outcomes included: personalised advice; brief intervention; behavioural supports (handouts and/or referrals) and physician follow-up. Reported adverse events were rare. Research gaps include optimal timing and length of follow-up, and the long-term and cost-effectiveness of interventions. Summary/Conclusion: Several characteristics of physical activity counselling by PCPs for patients with chronic disease may improve clinical outcomes, although research gaps remain. Studies exploring the effectiveness of physical activity prescription for individuals with chronic conditions are urgently needed.

16.
Sports Med Open ; 7(1): 49, 2021 Jul 19.
Artigo em Inglês | MEDLINE | ID: mdl-34279765

RESUMO

High-intensity interval training (HIIT) is an increasingly popular form of aerobic exercise which includes bouts of high-intensity exercise interspersed with periods of rest. The health benefits, risks, and optimal design of HIIT are still unclear. Further, most research on HIIT has been done in young and middle-aged adults, and as such, the tolerability and effects in senior populations are less well-known. The purpose of this scoping review was to characterize HIIT research that has been done in older adults including protocols, feasibility, and safety and to identify gaps in the current knowledge. Five databases were searched with variations of the terms, "high-intensity interval training" and "older adults" for experimental or quasi-experimental studies published in or after 2009. Studies were included if they had a treatment group with a mean age of 65 years or older who did HIIT, exclusively. Of 4644 papers identified, 69 met the inclusion criteria. The average duration of training was 7.9 (7.0) weeks (mean [SD]) and protocols ranged widely. The average sample size was 47.0 (65.2) subjects (mean [SD]). Healthy populations were the most studied group (n = 30), followed by subjects with cardiovascular (n = 12) or cardiac disease (n = 9), metabolic dysfunction (n = 8), and others (n = 10). The most common primary outcomes included changes in cardiorespiratory fitness (such as VO2peak) as well as feasibility and safety of the protocols as measured by the number of participant dropouts, adverse events, and compliance rate. HIIT protocols were diverse but were generally well-tolerated and may confer many health advantages to older adults. Larger studies and more research in clinical populations most representative of older adults are needed to further evaluate the clinical effects of HIIT in these groups.

17.
Front Aging Neurosci ; 13: 643809, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33935686

RESUMO

Background: The impact of exercise on cognition in older adults with hypertension and subjective cognitive decline (SCD) is unclear. Objectives: We determined the influence of high-intensity interval training (HIIT) combined with mind-motor training on cognition and systolic blood pressure (BP) in older adults with hypertension and SCD. Methods: We randomized 128 community-dwelling older adults [age mean (SD): 71.1 (6.7), 47.7% females] with history of hypertension and SCD to either HIIT or a moderate-intensity continuous training (MCT) group. Both groups received 15 min of mind-motor training followed by 45 min of either HIIT or MCT. Participants exercised in total 60 min/day, 3 days/week for 6 months. We assessed changes in global cognitive functioning (GCF), Trail-Making Test (TMT), systolic and diastolic BP, and cardiorespiratory fitness. Results: Participants in both groups improved diastolic BP [F (1, 87.32) = 4.392, p = 0.039], with greatest effect within the HIIT group [estimated mean change (95% CI): -2.64 mmHg, (-4.79 to -0.48), p = 0.017], but no between-group differences were noted (p = 0.17). Both groups also improved cardiorespiratory fitness [F (1, 69) = 34.795, p < 0.001], and TMT A [F (1, 81.51) = 26.871, p < 0.001] and B [F (1, 79.49) = 23.107, p < 0.001]. There were, however, no within- or between-group differences in GCF and systolic BP at follow-up. Conclusion: Despite improvements in cardiorespiratory fitness, exercise of high- or moderate-intensity, combined with mind-motor training, did not improve GCF or systolic BP in individuals with hypertension and SCD. Clinical Trial Registration: ClinicalTrials.gov (NCT03545958).

19.
Osteoarthr Cartil Open ; 3(4): 100213, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36474755

RESUMO

Objective: EP-104IAR is a novel, sustained-release, intra-articular (IA) formulation of the corticosteroid fluticasone propionate (FP), in development for the treatment of osteoarthritis (OA) pain. This study evaluated the safety, pharmacokinetics (PK) and efficacy of a single dose of EP-104IAR in patients with OA of the knee. Design: This was a multi-center, randomized, double-blind, placebo-controlled trial performed at 3 sites in Canada. Subjects with moderate to severe pain received either a single dose of the investigational product EP-104IAR (15 â€‹mg) or placebo (vehicle) and were evaluated for up to 42 weeks. The primary outcome measures were safety and PK. The study was not powered to assess efficacy, however patient reported outcome measures were analyzed to evaluate pain and symptom relief. Results: Thirty-two subjects were randomized (21 women, 11 men, mean age: 64.8 years). EP-104IAR was well tolerated. Average serum cortisol levels showed no clinically significant deviations compared to placebo and remained within the normal range of cortisol variation. Plasma PK concentrations were within acceptable safety margins, compared to marketed FP products. Synovial fluid FP levels were approximately 2 orders of magnitude higher and at efficacious concentrations for most subjects. Efficacy evaluations indicated that EP-104IAR provided an immediate improvement of OA symptoms and these effects persisted for 8-12 weeks consistently across all measures. Conclusions: This study provides evidence that 15 â€‹mg of EP-104IAR is well tolerated and has the potential for efficacy in OA patients. These data support further examination of EP-104IAR in larger clinical studies.

20.
Int J Behav Nutr Phys Act ; 17(1): 139, 2020 11 19.
Artigo em Inglês | MEDLINE | ID: mdl-33208166

RESUMO

BACKGROUND: Mobile health applications (mHealth apps) targeting physical inactivity have increased in popularity yet are usually limited by low engagement. This study examined the impact of adding team-based incentives (Step Together Challenges, STCs) to an existing mHealth app (Carrot Rewards) that rewarded individual physical activity achievements. METHODS: A 24-week quasi-experimental study (retrospective matched pairs design) was conducted in three Canadian provinces (pre-intervention: weeks 1-12; intervention: weeks 13-24). Participants who used Carrot Rewards and STCs (experimental group) were matched with those who used Carrot Rewards only (controls) on age, gender, province and baseline mean daily step count (±500 steps/d). Carrot Rewards users earned individual-level incentives (worth $0.04 CAD) each day they reached a personalized daily step goal. With a single partner, STC users could earn team incentives ($0.40 CAD) for collaboratively reaching individual daily step goals 10 times in seven days (e.g., Partner A completes four goals and Partner B completes six goals in a week). RESULTS: The main analysis included 61,170 users (mean age = 32 yrs.; % female = 64). Controlling for pre-intervention mean daily step count, a significant difference in intervention mean daily step count favoured the experimental group (p < 0.0001; ηp2 = 0.024). The estimated marginal mean group difference was 537 steps per day, or 3759 steps per week (about 40 walking min/wk). Linear regression suggested a dose-response relationship between the number of STCs completed (app engagement) and intervention mean daily step count (adjusted R2 = 0.699) with each new STC corresponding to approximately 200 more steps per day. CONCLUSION: Despite an explosion of physical activity app interest, low engagement leading to small or no effects remains an industry hallmark. In this paper, we found that adding modest team-based incentives to the Carrot Rewards app increased mean daily step count, and importantly, app engagement moderated this effect. Others should consider novel small-teams based approaches to boost engagement and effects.


Assuntos
Promoção da Saúde , Aplicativos Móveis , Motivação/fisiologia , Recompensa , Caminhada/fisiologia , Adulto , Estudos de Casos e Controles , Feminino , Monitores de Aptidão Física , Promoção da Saúde/economia , Promoção da Saúde/métodos , Humanos , Masculino
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