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BACKGROUND: We initially reported on the cost-effectiveness of a 6-month randomized controlled implementation trial which evaluated Health TAPESTRY, a primary care program for older adults, at the McMaster Family Health Team (FHT) site and 5 other FHT sites in Ontario, Canada. While there were no statistically significant between-group differences in outcomes at month 6 post randomization, positive outcomes were observed at the McMaster FHT site, which recruited 40% (204/512) of the participants. The objective of this post-hoc study was to determine the cost-effectiveness of Health TAPESTRY based on data from the McMaster FHT site. METHODS: Costs included the cost to implement Health TAPESTRY at McMaster as well as healthcare resource consumed, which were costed using publicly available sources. Health-related-quality-of-life was evaluated with the EQ-5L-5L at baseline and at month 6 post randomization. Quality-adjusted-life-years (QALYs) were calculated under an-area-under the curve approach. Unadjusted and adjusted regression analyses (two independent regression analyses on costs and QALYs, seemingly unrelated regression [SUR], net benefit regression) as well as difference-in-difference and propensity score matching (PSM) methods, were used to deal with the non-randomized nature of the trial. Sampling uncertainty inherent to the trial data was estimated using non-parametric bootstrapping. The return on investment (ROI) associated with Health TAPESTRY was calculated. All costs were reported in 2021 Canadian dollars. RESULTS: With an intervention cost of $293/patient, Health TAPESTRY was the preferred strategy in the unadjusted and adjusted analyses. The results of our bootstrap analyses indicated that Health TAPESTRY was cost-effective compared to usual care at commonly accepted WTP thresholds. For example, if decision makers were willing to pay $50,000 per QALY gained, the probability of Health TAPESTRY to be cost effective compared to usual care varied from 0.72 (unadjusted analysis) to 0.96 (SUR) when using a WTP of $50,000/QALY gained. The DID and ROI analyses indicated that Health Tapestry generated a positive ROI. CONCLUSION: Health TAPESTRY was the preferred strategy when implemented at the McMaster FHT. We caution care in interpreting the results because of the post-hoc nature of the analyses and limited sample size based on one site.
Assuntos
Atenção Primária à Saúde , Anos de Vida Ajustados por Qualidade de Vida , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Análise de Custo-Efetividade , Ontário , Atenção Primária à Saúde/economia , Qualidade de VidaRESUMO
In 2019, Discovery Health published a risk adjustment model to determine standardised mortality rates across South African private hospital systems, with the aim of contributing towards quality improvement in the private healthcare sector. However, the model suffers from limitations due to its design and its reliance on administrative data. The publication's aim of facilitating transparency is unfortunately undermined by shortcomings in reporting. When designing a risk prediction model, patient-proximate variables with a sound theoretical or proven association with the outcome of interest should be used. The addition of key condition-specific clinical data points at the time of hospital admission will dramatically improve model performance. Performance could be further improved by using summary risk prediction scores such as the EUROSCORE II for coronary artery bypass graft surgery or the GRACE risk score for acute coronary syndrome. In general, model reporting should conform to published reporting standards, and attempts should be made to test model validity by using sensitivity analyses. In particular, the limitations of machine learning prediction models should be understood, and these models should be appropriately developed, evaluated and reported.
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Setor Privado , Risco Ajustado , Humanos , África do Sul , Mortalidade Hospitalar , Hospitais PrivadosRESUMO
BACKGROUND AND OBJECTIVE: Individuals with Alzheimer disease and dementia experience cognitive decline and reduction in physical capabilities. Engaging in cognitive challenges and physical exercises is effective in reducing age-related cognitive and physical decline. It is believed that physical activity in the context of cognitive challenges might enhance the process of neurogenesis in the adult brain, but how effective are such interventions? Is there enough evidence to support that dual-task training is more effective than cognitive or physical training alone? To what extent can such training improve cognitive and physical functions in patients at various stages of cognitive decline? METHODOLOGY: This systematic review with meta-analysis summarizes the emerging evidence of dual-task training for enhancing cognitive and physical functions in older individuals with cognitive impairment, dementia or Alzheimer's disease. A systematic search was carried out in MEDLINE, PubMed, EMBASE, and Cochrane Library with the following search terms: randomized control trials, dual-task training, SCD, MCI, dementia, and Alzheimer's disease. RESULTS: A total of 21 studies with 2,221 participants were identified. The results of dual-task tanning intervention are summarized as change in global cognitive function; SMD = 0.24, (P= 0.002), memory; SMD = 0.28, (P = 0.000), executive function; SMD = 0.35, (P = 0.000), attention; SMD = -0.19, (P = 0.1), gait speed; SMD = 0.26, (P = 0.007), dual-task cost; SMD 0.56, (P = 0.000), and balance; SMD 0.36, (P = 0.004). CONCLUSION: Primary analysis showed a small-to-medium positive effect of dual-task training interventions on cognitive functions and medium-to-large positive effect on gait functions and balance.
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Doença de Alzheimer , Disfunção Cognitiva , Idoso , Cognição , Função Executiva , Marcha , HumanosRESUMO
Interscalene brachial plexus block is the standard regional analgesic technique for shoulder surgery. Given its adverse effects, alternative techniques have been explored. Reports suggest that the erector spinae plane block may potentially provide effective analgesia following shoulder surgery. However, its analgesic efficacy for shoulder surgery compared with placebo or local anaesthetic infiltration has never been established. We conducted a randomised controlled trial to compare the analgesic efficacy of pre-operative T2 erector spinae plane block with peri-articular infiltration at the end of surgery. Sixty-two patients undergoing arthroscopic shoulder repair were randomly assigned to receive active erector spinae plane block with saline peri-articular injection (n = 31) or active peri-articular injection with saline erector spinae plane block (n = 31) in a blinded double-dummy design. Primary outcome was resting pain score in recovery. Secondary outcomes included pain scores with movement; opioid use; patient satisfaction; adverse effects in hospital; and outcomes at 24 h and 1 month. There was no difference in pain scores in recovery, with a median difference (95%CI) of 0.6 (-1.9-3.1), p = 0.65. Median postoperative oral morphine equivalent utilisation was significantly higher in the erector spinae plane group (21 mg vs. 12 mg; p = 0.028). Itching was observed in 10% of patients who received erector spinae plane block and there was no difference in the incidence of significant nausea and vomiting. Patient satisfaction scores, and pain scores and opioid use at 24 h were similar. At 1 month, six (peri-articular injection) and eight (erector spinae plane block) patients reported persistent pain. Erector spinae plane block was not superior to peri-articular injection for arthroscopic shoulder surgery.
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Artroscopia/métodos , Bloqueio Nervoso/métodos , Manejo da Dor/métodos , Dor Pós-Operatória/prevenção & controle , Músculos Paraespinais/efeitos dos fármacos , Articulação do Ombro/cirurgia , Adulto , Anestésicos Locais/administração & dosagem , Artroscopia/efeitos adversos , Feminino , Seguimentos , Humanos , Injeções Intra-Articulares/métodos , Masculino , Pessoa de Meia-Idade , Músculos Paraespinais/diagnóstico por imagem , Músculos Paraespinais/inervação , Articulação do Ombro/diagnóstico por imagem , Articulação do Ombro/efeitos dos fármacos , Ultrassonografia de Intervenção/métodosRESUMO
This is the first report on the fragility of results from randomized controlled trials (RCTs) for the treatment of osteoporosis. The results of aforementioned RCTs appear to depend on a small number of events and are generally statistically fragile. INTRODUCTION: Osteoporosis remains a health concern worldwide. Evidence-based guideline recommendations that are mainly based on results of clinical trials are important to clinical decision-making. The fragility index (FI) is a novel statistical metric to measure the fragility of results from an RCT. Our study aimed to analyze the fragility of the clinical trials referenced in the guidelines for the treatment of osteoporosis. METHODS: Trials were included if they investigated primary osteoporosis, randomized patients to treatment or control in a 1:1 design, and reported fracture outcome as the primary endpoint. The FI and fragility quotient (FQ) were calculated for assessing the robustness of results from the eligible RCTs. An FI was defined as the minimum number of events in the intervention group that needs to change from a non-event to an event in order to render a significant result non-significant (or vice versa). The FQ was calculated by dividing the FI by the sample size of the trial. RESULTS: Of the 372 RCTs identified from the guidelines, 42 were eligible for analyses. Their median FI was 10 (25th-75th percentile [Q1-Q3]: 4-18), with a median FQ of 0.007 (Q1-Q3: 0.0017-0.019). Approximately one third of the RCTs had a FI of less than or equal to 5. There were 17 (40.5%) trials where the number of patients lost to follow-up was greater than the FI. The FI was significantly associated with sample size, journal impact factor, and the percent of patients lost to follow-up. CONCLUSION: Results from some RCTs supporting guideline recommendations for the treatment of osteoporosis depend on a small number of events. The FI and FQ may provide additional, intuitive metrics to help interpret the robustness of trial results.
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Osteoporose , Humanos , Osteoporose/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Retrospectivos , Tamanho da AmostraRESUMO
BACKGROUND: Using residual values calculated from models regressing appendicular lean mass on fat mass and height is one of several suggested strategies for adjusting appendicular lean mass for body size when measuring sarcopenia. However, special consideration is required when using this technique in different subgroups in order to capture the correct individuals as sarcopenic. OBJECTIVES: To provide guidance about how to conduct stratified analyses for the regression adjustment technique using age groups as an example. DESIGN: Cross-sectional study. SETTING: Data collected at baseline (2012-2015) for the Canadian Longitudinal Study on Aging. PARTICIPANTS: Community dwelling participants of European descent aged 45 to 85 years (n=25,399). MEASUREMENTS: Appendicular lean mass, height, and weight were measured. Sex-specific residuals were calculated in participants before and after stratifying participants by age group (45-54, 55-64, 65-74, 75-85 years). Cut offs corresponding to the sex-specific 20th percentile residual values in participants ≥65 years were determined first in the residuals calculated in all participants and residuals calculated in only those aged ≥65 years. For each set of cut offs, the percentage of age and sex-stratified participants with low appendicular lean mass were compared for the residuals calculated in all participants and the residuals calculated after stratifying by age. RESULTS: In 12,622 males and 12,737 females, regardless of the cut off used, the percentage of participants with low appendicular lean mass decreased with age when residuals were calculated after age stratification. When the residuals were calculated in all participants, the percentage of participants with sarcopenia increased from the youngest to the oldest age groups. CONCLUSIONS: Sex-specific residuals in all participants should be calculated prior to stratifying the sample by age group, or other stratification variables, for the purposes of developing appendicular lean mass cut offs or subgroup analyses.
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Projetos de Pesquisa , Sarcopenia , Distribuição por Idade , Idoso , Idoso de 80 Anos ou mais , Envelhecimento , Composição Corporal , Canadá/epidemiologia , Estudos Transversais , Feminino , Humanos , Modelos Lineares , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Sarcopenia/diagnóstico , Sarcopenia/epidemiologiaRESUMO
People experience rapid bone loss shortly after a spinal cord injury (SCI), but the long-term bone changes are yet to be confirmed. This study showed that trabecular bone may have reached a steady state, whereas cortical bone continued to decline in people with a chronic SCI (mean time post injury: 15.5 ± 10 years). INTRODUCTION: (1) To explore changes in bone [primary measure: trabecular volumetric bone mineral density (vBMD); secondary measures: cortical vBMD, cortical thickness, cortical cross-sectional area (CSA), and polar moment of inertia] over 2 years in individuals with a chronic spinal cord injury (SCI). (2) To explore whether muscle density changes were potential correlates of the observed bone changes. METHODS: This study is a secondary data analysis of a prospective, observational study involving 70 people with a chronic SCI (≥ 2 years post injury). The study included 4 strata of participants with diverse impairments: (1) Paraplegia (T1-T12) motor complete American Spinal Injury Association Impairment Scale (AIS) A/B (n = 23), (2) Paraplegia motor incomplete AIS C/D (n = 11), (3) Tetraplegia (C2-C8) AIS A/B (n = 22), and (4) Tetraplegia AIS C/D (n = 14). Peripheral quantitative computed tomography scans were taken at the 4% (distal tibia), 38% (diaphyseal tibia), and 66% (muscle cross-sectional area) tibia sites by measuring from the distal to proximal tibia starting at the inferior border of the medial malleolus. The tibia sites were assessed annually over a span of 2 years. Comparisons were made using a paired-samples t test and simple linear regression was used to adjust for sex, time post injury, and bisphosphonate use. RESULTS: We observed no changes in trabecular vBMD at the 4% tibia site, but there was a statistically significant decline in cortical vBMD, cortical thickness, and CSA at the 38% tibia site. Changes in muscle density were not associated with the decreases observed in cortical bone. CONCLUSION: Our findings suggest that individuals with chronic SCI (mean duration of injury: 15.5 ± 10 years) may have reached a plateau in bone loss with respect to trabecular bone, but cortical bone loss can continue well into the chronic stages.
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Densidade Óssea , Traumatismos da Medula Espinal , Diáfises , Humanos , Estudos Prospectivos , Traumatismos da Medula Espinal/complicações , Traumatismos da Medula Espinal/diagnóstico por imagem , Tíbia/diagnóstico por imagemRESUMO
In response to the COVID-19 pandemic, numerous countries worldwide declared national states of emergency and implemented interventions to minimise the risk of transmission among the public. Evidence was needed to inform strategies for limiting COVID-19 transmission on public transport. On 20 March 2020, we searched MEDLINE, CENTRAL, Web of Science and the World Health Organization's database of 'Global research on coronavirus disease (COVID-19)' to conduct a rapid review on interventions that reduce viral transmission on public ground transport. After screening 74 records, we identified 4 eligible studies. These studies suggest an increased risk of viral transmission with public transportation use that may be reduced with improved ventilation. International and national guidelines suggest the following strategies: keep the public informed, stay at home when sick, and minimise public transport use. Where use is unavoidable, environmental control, respiratory etiquette and hand hygiene are recommended, while a risk-based approach needs to guide the use of non-medical masks.
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Infecções por Coronavirus/transmissão , Pneumonia Viral/transmissão , Saúde Pública , Meios de Transporte , COVID-19 , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Higiene das Mãos , Humanos , Máscaras , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Infecções Respiratórias/transmissão , Infecções Respiratórias/virologia , VentilaçãoRESUMO
This analysis examined costs/resources of 141 women with vertebral fractures, randomised to a home exercise programme or control group. Total, mean costs and the incremental cost-effectiveness ratio (ICER) were calculated. Quality of life was collected. Cost drivers were caregiver time, medications and adverse events (AEs). Results show adding an exercise programme may reduce the risk of AEs. INTRODUCTION: This exploratory economic analysis examined the health resource utilisation and costs experienced by women with vertebral fractures, and explored the effects of home exercise on those costs. METHODS: Women ≥ 65 years with one or more X-ray-confirmed vertebral fractures were randomised 1:1 to a 12-month home exercise programme or equal attention control group. Clinical and health system resources were collected during monthly phone calls and daily diaries completed by participants. Intervention costs were included. Unit costs were applied to health system resources. Quality of life (QoL) information was collected via EQ-5D-5L at baseline, 6 and 12 months. RESULTS: One hundred and forty-one women were randomised. Overall total costs (CAD 2018) were $664,923 (intervention) and $614,033 (control), respectively. The top three cost drivers were caregiver time ($250,269 and $240,811), medications ($151,000 and $122,145) and AEs ($58,807 and $71,981). The mean cost per intervention participant of $9365 ± $9988 was higher compared with the mean cost per control participant of $8772 ± $9718. The mean EQ-5D index score was higher for the intervention participants (0.81 ± 0.11) compared with that of controls (0.79 ± 0.13). The differences in quality-adjusted life year (QALY) (0.02) and mean cost ($593) were used to calculate the ICER of $29,650. CONCLUSIONS: Women with osteoporosis with a previous fracture experience a number of resources and associated costs that impact their care and quality of life. Caregiver time, medications and AEs are the biggest cost drivers for this population. The next steps would be to expand this feasibility study with more participants, longer-term follow-up and more regional variability.
Assuntos
Análise Custo-Benefício , Terapia por Exercício , Custos de Cuidados de Saúde , Fraturas da Coluna Vertebral/economia , Idoso , Feminino , Humanos , Projetos Piloto , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de VidaRESUMO
BACKGROUND: Pelvic floor muscles (PFM) and rectus abdominis muscles (RAM) of pregnant diabetic rats exhibit atrophy, co-localization of fast and slow fibers and an increased collagen type I/III ratio. However, the role of similar PFM or RAM hyperglycemic-related myopathy in women with gestational diabetes mellitus (GDM) remains poorly investigated. This study aims to assess the frequency of pelvic floor muscle disorders and pregnancy-specific urinary incontinence (PS-UI) 12 months after the Cesarean (C) section in women with GDM. Specifically, differences in PFM/RAM hyperglycemic myopathy will be evaluated. METHODS: The Diamater is an ongoing cohort study of four groups of 59 pregnant women each from the Perinatal Diabetes Research Centre (PDRC), Botucatu Medical School (FMB)-UNESP (São Paulo State University), Brazil. Diagnosis of GDM and PS-UI will be made at 24-26 weeks, with a follow-up at 34-38 weeks of gestation. Inclusion in the study will occur at the time of C-section, and patients will be followed at 24-48 h, 6 weeks and 6 and 12 months postpartum. Study groups will be classified as (1) GDM plus PS-UI; (2) GDM without PS-UI; (3) Non-GDM plus PS-UI; and (4) Non-GDM without PS-UI. We will analyze relationships between GDM, PS-UI and hyperglycemic myopathy at 12 months after C-section. The mediator variables to be evaluated include digital palpation, vaginal squeeze pressure, 3D pelvic floor ultrasound, and 3D RAM ultrasound. RAM samples obtained during C-section will be analyzed for ex-vivo contractility, morphological, molecular and OMICS profiles to further characterize the hyperglycemic myopathy. Additional variables to be evaluated include maternal age, socioeconomic status, educational level, ethnicity, body mass index, weight gain during pregnancy, quality of glycemic control and insulin therapy. DISCUSSION: To our knowledge, this will be the first study to provide data on the prevalence of PS-UI and RAM and PFM physical and biomolecular muscle profiles after C-section in mothers with GDM. The longitudinal design allows for the assessment of cause-effect relationships between GDM, PS-UI, and PFMs and RAMs myopathy. The findings may reveal previously undetermined consequences of GDM.
Assuntos
Diabetes Gestacional/fisiopatologia , Doenças Musculares/fisiopatologia , Incontinência Urinária/fisiopatologia , Adulto , Brasil , Cesárea , Estudos de Coortes , Feminino , Idade Gestacional , Ganho de Peso na Gestação , Humanos , Idade Materna , Contração Muscular/fisiologia , Força Muscular/fisiologia , Palpação , Diafragma da Pelve/fisiopatologia , Período Pós-Parto , Gravidez , Reto do Abdome/fisiopatologia , VaginaRESUMO
BACKGROUND: Opioids remain the mainstay therapy for post-surgical pain. Although both morphine and hydromorphone are potent analgesics, it has been suggested that hydromorphone is clinically better. Our primary objective was to compare morphine with hydromorphone for achieving satisfactory analgesia with minimal emesis (SAME). METHODS: We performed a multicentre RCT in 402 patients having ambulatory surgery. A random computer-generated allocation, stratified by site, was developed by our pharmacy. Concealment was achieved by allocating patients to study groups by nurses using sequentially coded study medication syringes having equi-analgesic doses, made available in the postoperative recovery room. Patients, health providers, and research personnel were blinded. The operating-room protocol allowed for routine anaesthetic management, excluding the use of study medications. Study medications were administered by recovery nurses as per an algorithm. Analyses utilised the intention-to-treat principle, and regression analyses were used for outcomes as appropriate and using multiple imputation. RESULTS: Of 751 patients, 402 were randomised between morphine (n=199) and hydromorphone (n=203). Baseline and intraoperative variables were comparable across the groups. The odds of achieving SAME were similar between the groups (odds ratio: 1.01; 95% confidence interval: 0.57-1.80). There were no differences in the side-effects of severe itching, respiratory depression, or sedation. Patient satisfaction, discharge times, and post-discharge outcomes, including pain and nausea/vomiting over 24 h, were also comparable. CONCLUSIONS: There was no difference between morphine and hydromorphone regarding analgesia and common side-effects. The appearance of dose-limiting side-effects is idiosyncratic; the clinical decision must be based on individual responses. CLINICAL TRIAL REGISTRATION: NCT02223377.
Assuntos
Procedimentos Cirúrgicos Ambulatórios/efeitos adversos , Analgésicos Opioides/uso terapêutico , Hidromorfona/uso terapêutico , Morfina/uso terapêutico , Dor Pós-Operatória/tratamento farmacológico , Náusea e Vômito Pós-Operatórios/induzido quimicamente , Adulto , Idoso , Analgésicos Opioides/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Hidromorfona/efeitos adversos , Masculino , Pessoa de Meia-Idade , Morfina/efeitos adversos , Manejo da Dor/métodos , Medição da Dor/métodos , Dor Pós-Operatória/etiologia , Cuidados Pós-Operatórios/métodos , Resultado do TratamentoRESUMO
Background: sarcopenia in ageing is a progressive decrease in muscle mass, strength and/or physical function. This review aims to summarise the definitions of sarcopenia in community-dwelling older adults and explore similarities and differences in prevalence estimates by definition. Methods: a systematic review was conducted to identify articles which estimated sarcopenia prevalence in older populations using search terms for sarcopenia and muscle mass. Overall prevalence for each sarcopenia definition was estimated stratified by sex and ethnicity. Secondary analyses explored differences between studies and within definitions, including participant age, muscle mass measurement techniques and thresholds for muscle mass and gait speed. Results: in 109 included articles, eight definitions of sarcopenia were identified. The lowest pooled prevalence estimates came from the European Working Group on Sarcopenia/Asian Working Group on Sarcopenia (12.9%, 95% confidence interval: 9.9-15.9%), International Working Group on Sarcopenia (9.9%, 3.2-16.6%) and Foundation for the National Institutes of Health (18.6%, 11.8-25.5%) definitions. The highest prevalence estimates were for the appendicular lean mass (ALM)/weight (40.4%, 19.5-61.2%), ALM/height (30.4%, 20.4-40.3%), ALM regressed on height and weight (30.4%, 20.4-40.3%) and ALM / body mass index (24.2%, 18.3-30.1%) definitions. Within definitions, the age of study participants and the muscle mass cut points used were substantive sources of between-study differences. Conclusion: estimates of sarcopenia prevalence vary from 9.9 to 40.4%, depending on the definition used. Significant differences in prevalence exist within definitions across populations. This lack of agreement between definitions needs to be better understood before sarcopenia can be appropriately used in a clinical context.
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Vida Independente/estatística & dados numéricos , Sarcopenia/epidemiologia , Fatores Etários , Idoso/estatística & dados numéricos , Feminino , Humanos , Masculino , Força Muscular , Prevalência , Sarcopenia/diagnóstico , Fatores SexuaisRESUMO
BACKGROUND: The research objectives of the Femoroacetabular Impingement Randomised controlled Trial (FIRST) are to assess whether surgical correction of the hip impingement morphology (arthroscopic osteochondroplasty) with or without labral repair, in adults aged 18-50 years diagnosed with non-arthritic femoroacetabular impingement (FAI), provides decreased pain and improved health-related quality of life at 12 months compared to arthroscopic lavage of the hip joint. This article describes the statistical analysis plan for the FIRST trial. METHODS/DESIGN: FIRST is an ongoing multi-centre, blinded randomised controlled trial of 220 patients who have been diagnosed with FAI and are optimized for surgical intervention. This article describes the overall analysis principles, including how participants will be included in each analysis, the presentation of the results, adjustments for covariates, the primary and secondary outcomes and their respective analyses. In addition, we will present the planned sensitivity and subgroup analyses. DISCUSSION: Our rationale for FIRST is based upon (1) an epidemic of FAI surgery with resultant increased healthcare costs over that last decade, (2) worldwide disparity in perceptions about its utility, and (3) consensus that definitive evidence for or against surgical approaches is lacking. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01623843 . Registered on 20 June 2012.
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Artroscopia/métodos , Impacto Femoroacetabular/cirurgia , Qualidade de Vida , Irrigação Terapêutica/métodos , Adolescente , Adulto , Artroscopia/efeitos adversos , Artroscopia/estatística & dados numéricos , Canadá , Interpretação Estatística de Dados , Feminino , Impacto Femoroacetabular/diagnóstico , Impacto Femoroacetabular/fisiopatologia , Impacto Femoroacetabular/psicologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Medição da Dor , Ensaios Clínicos Controlados Aleatórios como Assunto , Recuperação de Função Fisiológica , Irrigação Terapêutica/efeitos adversos , Irrigação Terapêutica/estatística & dados numéricos , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
We pilot-tested a trial of home exercise on individuals with osteoporosis and spine fracture. Our target enrollment was met, though it took longer than expected. Participants stayed in the study and completed the exercise program with no safety concerns. Future trials should expand the inclusion criteria and consider other changes. PURPOSE: Osteoporotic fragility fractures create a substantial human and economic burden. There have been calls for a large randomized controlled trial examining the effect of exercise on fracture incidence. The B3E pilot trial was designed to evaluate the feasibility of a large trial examining the effects of home exercise on individuals at high risk of fracture. METHODS: Community-dwelling women ≥ 65 years with radiographically confirmed vertebral compression fractures were recruited at seven sites in Canada and Australia. We randomized participants in a 1:1 ratio to a 12-month home exercise program or equal attention control group, both delivered by a physiotherapist (PT). Participants received six PT home visits in addition to monthly phone calls from the PT and a blinded research assistant. The primary feasibility outcomes of the study were recruitment rate (20 per site in 1 year), retention rate (75% completion), and intervention adherence rate (60% of weeks meeting exercise goals). Secondary outcomes included falls, fractures and adverse events. RESULTS: One hundred forty-one participants were recruited; an average of 20 per site, though most sites took longer than anticipated. Retention and adherence met the criteria for success: 92% of participants completed the study; average adherence was 66%. The intervention group did not differ significantly in the number of falls (IRR 0.97, 95% CI 0.58 to 1.63) or fragility fractures (OR 1.11, 95% CI 0.60 to 2.05) compared to the control group. There were 18 serious adverse events in the intervention group and 12 in the control group. CONCLUSION: An RCT of home exercise in women with vertebral fractures is feasible but recruitment was a challenge. Suggestions are made for the conduct of future trials.
Assuntos
Terapia por Exercício/métodos , Fraturas por Osteoporose/prevenção & controle , Fraturas da Coluna Vertebral/prevenção & controle , Acidentes por Quedas/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Terapia por Exercício/efeitos adversos , Estudos de Viabilidade , Feminino , Humanos , Osteoporose Pós-Menopausa/complicações , Osteoporose Pós-Menopausa/reabilitação , Fraturas por Osteoporose/etiologia , Cooperação do Paciente , Projetos Piloto , Autocuidado/métodos , Método Simples-Cego , Fraturas da Coluna Vertebral/etiologiaRESUMO
BACKGROUND: Children with acute lymphoblastic leukemia (ALL) have increased risk of thromboembolism (TE). However, the predictors of ALL-associated TE are as yet uncertain. OBJECTIVE: This exploratory, prospective cohort study evaluated the effects of clinical (age, gender, ALL risk group) and laboratory variables (hematological parameters, ABO blood group, inherited and acquired prothrombotic defects [PDs]) at diagnosis on the development of symptomatic TE (sTE) in children (aged 1 to ≤18) treated on the Dana-Farber Cancer Institute ALL 05-001 study. PROCEDURES: Samples collected prior to the start of ALL therapy were evaluated for genetic and acquired PDs (proteins C and S, antithrombin, procoagulant factors VIII (FVIII:C), IX, XI and von Willebrand factor antigen levels, gene polymorphisms of factor V G1691A, prothrombin gene G20210A and methylene tetrahydrofolate reductase C677T, anticardiolipin antibodies, fasting lipoprotein(a), and homocysteine). RESULTS: Of 131 enrolled patients (mean age [range] 6.4 [1-17] years) 70 were male patients and 20 patients (15%) developed sTE. Acquired or inherited PD had no impact on the risk of sTE. Multivariable analyses identified older age (odds ratio [OR] 1.13; 95% confidence interval [CI]: 1.01, 1.26) and non-O blood group (OR 3.64, 95% CI: 1.06, 12.51) as independent predictors for development of sTE. Patients with circulating blasts had higher odds of developing sTE (OR 6.66; 95% CI: 0.82, 53.85). CONCLUSION: Older age, non-O blood group, and presence of circulating blasts, but not PDs, predicted the risk of sTE during ALL therapy. We recommend evaluation of these novel risk factors in the development of ALL-associated TE. If confirmed, these easily accessible variables at diagnosis can help develop a risk-prediction model for ALL-associated TE.
Assuntos
Biomarcadores/análise , Terapia Combinada/efeitos adversos , Leucemia-Linfoma Linfoblástico de Células Precursoras/terapia , Trombose/diagnóstico , Adolescente , Criança , Pré-Escolar , Feminino , Seguimentos , Humanos , Lactente , Masculino , Projetos Piloto , Prognóstico , Estudos Prospectivos , Fatores de Risco , Trombose/etiologia , Trombose/metabolismoRESUMO
Survivors of childhood brain tumours (SCBT) have increased cardiometabolic risks, but the determinants of these risks are unclear. This systematic review aims to compare the prevalence of overweight and obesity as well as adiposity measures between SCBT and non-cancer controls. The PubMed, EMBASE, MEDLINE, CINAHL and the Cochrane Library databases were searched. The primary outcomes were the prevalence of overweight and obesity based on body mass index. The secondary outcomes were adiposity measures including percent fat mass, waist-to-hip and waist-to-height ratios. Forty-one studies were included in the meta-analysis. The prevalence of overweight and obesity combined was similar between overall SCBT, SCBT excluding craniopharyngioma and non-cancer controls (42.6%, 95% CI 30.1-55.1 vs. 31.7%, 95% CI 20.4-43.0 vs. 40.4%, 95% CI 34.0-46.8). We also found that SCBT have higher percent fat mass (mean difference 4.1%, 95% CI 2.0-6.1), waist-to-hip ratio (mean difference 0.07, 95% CI 0.02-0.13) and waist-to-height ratio (mean difference 0.06, 95% CI 0.01-0.10) than non-cancer controls. We conclude that SCBT have similar overweight and obesity distribution but higher adiposity than non-cancer controls. More studies were needed to explore the determinants of adiposity and its contribution to cardiometabolic outcomes in SCBT.
Assuntos
Adiposidade , Neoplasias Encefálicas/terapia , Sobreviventes de Câncer , Sobrepeso/epidemiologia , Obesidade Infantil/epidemiologia , Adolescente , Neoplasias Encefálicas/diagnóstico , Neoplasias Encefálicas/epidemiologia , Distribuição de Qui-Quadrado , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Razão de Chances , Sobrepeso/diagnóstico , Sobrepeso/fisiopatologia , Obesidade Infantil/diagnóstico , Obesidade Infantil/fisiopatologia , Prevalência , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
INTRODUCTION: Approximately half of oral cancers are detected in advanced stages. The current gold standard is histopathological assessment of biopsied tissue, which is subjective and dependent on expertise. Straticyte™, a novel prognostic tool at the pre-market stage, that more accurately identifies patients at high risk for oral cancer than histopathology alone. This study conducts an early cost-effectiveness analysis (CEA) of Straticyte™ and histopathology versus histopathology alone for oral cancer diagnosis in adult patients. METHODS: A decision-analytic model was constructed after narrowing the scope of Straticyte™, and defining application paths. Data was gathered using the belief elicitation method, and systematic review and meta-analysis. The early CEA was conducted from private-payer and patient perspectives, capturing both direct and indirect costs over a five-year time horizon. One-way and probabilistic sensitivity analyses were conducted to investigate uncertainty. RESULTS: Compared to histopathology alone, histopathology with Straticyte™ was the dominant strategy, resulting in fewer cancer cases (31 versus 36 per 100 patients) and lower total costs per cancer case avoided (3,360 versus 3,553). This remained robust when Straticyte™ was applied to moderate and mild cases, but became slightly more expensive but still more effective than histopathology alone when Straticyte™ was applied to only mild cases. The probabilistic and one-way sensitivity analyses demonstrated that incorporating Straticyte™ to the current algorithm would be cost-effective over a wide range of parameters and willingness-to-pay values. CONCLUSION: This study demonstrates high probability that Straticyte™ and histopathology will be cost-effective, which encourages continued investment in the product. The analysis is informed by limited clinical data on Straticyte™, however as more data becomes available, more precise estimates will be generated.
RESUMO
STUDY DESIGN: Cross-sectional. OBJECTIVES: The objective of the study was to determine and report agreement in fracture risk stratification of adults with spinal cord injury (SCI) using (1) Canadian Association of Radiologists and Osteoporosis Canada (CAROC) and Canadian Fracture Risk Assessment (FRAX) tools with and without areal bone mineral density (aBMD) and (2) SCI-specific fracture thresholds. SETTING: Tertiary rehabilitation center, Ontario, Canada. METHODS: Community-dwelling adults with chronic SCI (n=90, C2-T12, AIS A-D) consented to participation. Femoral neck aBMD values determined 10-year fracture risk (CAROC and FRAX). Knee-region aBMD and distal tibia volumetric BMD values were compared to SCI-specific fracture thresholds. Agreements between CAROC and FRAX risk stratifications, and between fracture threshold risk stratification, were assessed using prevalence- and bias-adjusted Kappa statistics (PABAK). RESULTS: CAROC and FRAX assessment tools showed moderate agreement for post-menopausal women (PABAK=0.56, 95% confidence interval (CI): 0.27, 0.84) and men aged ⩾50 years (PABAK=0.51, 95% CI: 0.34, 0.67), with poor agreement for young men and pre-menopausal women (PABAK⩽0). Excellent agreement was evident between FRAX with and without aBMD in young adults and in those with motor incomplete injury (PABAK=0.86-0.92). In other subgroups, agreement ranged from moderate to substantial (PABAK=0.41-0.73). SCI-specific fracture thresholds (Eser versus Garland) showed poor agreement (PABAK⩽0). CONCLUSION: Fracture risk estimates among individuals with SCI vary substantially with the risk assessment tool. Use of SCI-specific risk factors to identify patients with high fracture risk is recommended until a validated SCI-specific tool for predicting fracture risk is developed.
Assuntos
Algoritmos , Fraturas Ósseas/complicações , Fraturas Ósseas/diagnóstico , Medição de Risco , Traumatismos da Medula Espinal/complicações , Adulto , Fatores Etários , Densidade Óssea , Doença Crônica , Estudos Transversais , Feminino , Fraturas Ósseas/epidemiologia , Humanos , Joelho/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Ossos Pélvicos/diagnóstico por imagem , Ossos Pélvicos/lesões , Estudos Prospectivos , Fatores Sexuais , Traumatismos da Medula Espinal/diagnóstico , Traumatismos da Medula Espinal/tratamento farmacológico , Traumatismos da Medula Espinal/epidemiologiaRESUMO
BACKGROUND: Survivors of childhood brain tumours (SCBT) are at risk of type 2 diabetes and cardiovascular diseases. Obesity is a major driver of cardiometabolic diseases in the general population, and interventions that tackle obesity may lower the risk of these chronic diseases. The goal of this systematic review was to summarize current evidence for the presence of interventions to manage obesity, including hypothalamic obesity, in SCBT. METHODS: The primary outcome of this review was the body mass index z-score change from baseline to the end of the intervention and/or follow-up. Literature searches were conducted in PsycINFO, CINAHL, the Cochrane Library, Medline, SPORTDiscus, EMBASE and PubMed. Two reviewers completed study evaluations independently. RESULTS: Eleven publications were included in this systematic review (lifestyle intervention n = 2, pharmacotherapy n = 6 and bariatric surgery n = 3). While some studies demonstrated effectiveness of interventions to manage obesity in SCBT and alter markers of obesity and cardiometabolic risk, the evidence base was limited and of low quality, and studies focused on hypothalamic obesity. We conclude that there is urgent need to conduct adequately powered trials of sufficient duration, using existing and novel therapies to manage obesity, reduce the burden of cardiometabolic disorders and improve outcomes in SCBT.