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Cannabis use among individuals with cancer is best understood using survey self-report. As cannabis remains federally illegal, surveys could be subject to nonresponse and measurement issues impacting data quality. We surveyed individuals using medical cannabis for a cancer-related condition in the Minnesota Medical Cannabis Program (MCP). Although survey responders are older, there are no differences by race and ethnicity, gender, or receipt of reduced cannabis registry enrollment fee. Responders made a more recent purchase and more recently completed an independent symptom assessment for the registry than nonresponders, suggesting some opportunity for nonresponse error. Among responders, self-report and MCP administrative data with respect to age, race, gender, registry certification, and cannabis purchase history were similar. Responders were less likely to report receipt of Medicaid than would be expected based on registry low-income enrollment eligibility. Although attention should be paid to potential for nonresponse error, surveys are a reliable tool to ascertain cannabis behavior patterns in this population.
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Exactitud de los Datos , Marihuana Medicinal , Neoplasias , Sistema de Registros , Humanos , Marihuana Medicinal/uso terapéutico , Neoplasias/epidemiología , Neoplasias/terapia , Masculino , Femenino , Persona de Mediana Edad , Adulto , Encuestas y Cuestionarios , Estados Unidos/epidemiología , Minnesota/epidemiología , Autoinforme , AncianoRESUMEN
BACKGROUND: Prior studies demonstrate that 20%-50% of adolescents and young adults (age 15-39 years) with acute lymphoblastic leukemia (ALL) receive care at specialty cancer centers, yet a survival benefit has been observed for patients at these sites. Our objective was to identify patients at risk of severe geographic barriers to specialty cancer center-level care. METHODS: We used data from the North American Association of Central Cancer Registries Cancer in North America database to identify adolescent and young adult ALL patients diagnosed between 2004 and 2016 across 43 US states. We calculated driving distance and travel time from counties where participants lived to the closest specialty cancer center sites. We then used multivariable logistic regression models to examine the relationship between sociodemographic characteristics of counties where adolescent and young adult ALL patients resided and the need to travel more than 1 hour to obtain care at a specialty cancer center. RESULTS: Among 11â813 adolescent and young adult ALL patients, 43.4% were aged 25-39 years, 65.5% were male, 32.9% were Hispanic, and 28.7% had public insurance. We found 23.6% of adolescent and young adult ALL patients from 60.8% of included US counties would be required to travel more than 1 hour one way to access a specialty cancer center. Multivariable models demonstrate that patients living in counties that are nonmetropolitan, with lower levels of educational attainment, with higher income inequality, with lower internet access, located in primary care physician shortage areas, and with fewer hospitals providing chemotherapy services are more likely to travel more than 1 hour to access a specialty cancer center. CONCLUSIONS: Substantial travel-related barriers exist to accessing care at specialty cancer centers across the United States, particularly for patients living in areas with greater concentrations of historically marginalized communities.
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Instituciones Oncológicas , Accesibilidad a los Servicios de Salud , Leucemia-Linfoma Linfoblástico de Células Precursoras , Viaje , Humanos , Adolescente , Leucemia-Linfoma Linfoblástico de Células Precursoras/terapia , Masculino , Femenino , Adulto Joven , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Adulto , Viaje/estadística & datos numéricos , Estados Unidos , Instituciones Oncológicas/estadística & datos numéricos , Factores de Tiempo , Modelos Logísticos , Sistema de RegistrosRESUMEN
INTRODUCTION: Pain and disability after meniscectomy can be a substantial lifelong problem. There are few treatment options, especially for young people. Non-surgical management (rehabilitation) is an option but increasingly surgeons are performing meniscal allograft transplants (MATs) for these individuals. However, this is still an uncommon procedure, and availability and usage of MAT vary widely both in the UK and internationally. It is not known which treatment option is the most effective and cost-effective. METHODS AND ANALYSIS: The Meniscal Transplant surgery or Optimised Rehabilitation trial is an international, multicentre, randomised controlled trial. The aim is to compare the clinical and cost effectiveness of MAT versus an optimised package of individualised, progressive, rehabilitation that we have called personalised knee therapy (PKT).Participants will be recruited from sites across the UK, Australia, Canada and Belgium. The planned 144 participants provide at least 90% power to detect a 10-point difference in the Knee injury and Osteoarthritis Outcome Score (KOOS4) at 24-months post randomisation (primary outcome). A prospectively planned economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data including health utility, occupational status, sports participation, mental well-being, further treatment, and adverse events will be collected at 3, 6, 12, 18, and 24 months. Analysis will be on an intention-to-treat basis and reported in-line with the Consolidated Standards of Reporting Trials statement. ETHICS AND DISSEMINATION: The trial was approved by the London-Bloomsbury Research Ethics Committee on 19 August 2022 (22/LO/0327) and Northern Sydney Local Health District Human Research Ethics Committee, NSW, Australia on the 13 March 2023 (2022/ETH01890).Trial results will be disseminated via peer-reviewed publications, presentations at international conferences, in lay summaries and using social media as appropriate.This protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. TRIAL REGISTRATION NUMBER: ISRCTN87336549.
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Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Análisis Costo-Beneficio , Estudios Multicéntricos como Asunto , Meniscectomía , Meniscos Tibiales/cirugía , Meniscos Tibiales/trasplante , Lesiones de Menisco Tibial/cirugía , Lesiones de Menisco Tibial/terapia , Lesiones de Menisco Tibial/rehabilitaciónRESUMEN
Background: The extra benefit of a programme of physiotherapy in addition to advice alone, following first-time traumatic shoulder dislocation, is uncertain. We compared the clinical and cost-effectiveness of a single session of advice with a single session of advice and a programme of physiotherapy. Objective: The primary objective was to quantify and draw inferences about observed differences in the Oxford Shoulder Instability Score between the trial treatment groups 6 months post randomisation, in adults with a first-time traumatic shoulder dislocation. Design: A pragmatic, multicentre, superiority, randomised controlled trial with embedded qualitative study. Setting: Forty-one hospitals in the UK NHS. Participants: Adults with a radiologically confirmed first-time traumatic anterior shoulder dislocation, being managed non-operatively. People with neurovascular complications or bilateral dislocations, and those unable to adhere to trial procedures or unable to attend physiotherapy within 6 weeks of injury, or who had previously been randomised, were excluded. Interventions: All participants received the same initial shoulder examination followed by advice to aid self-management, lasting up to 1 hour and administered by a physiotherapist (control). Participants randomised to receive an additional programme of physiotherapy were offered sessions lasting for up to 30 minutes, over a maximum duration of 4 months from the date of randomisation (intervention). Main outcome measures: The primary outcome measure was the Oxford Shoulder Instability Score. This is a self-completed outcome measure containing 12 questions (0-4 points each), with possible scores from 0 (worst function) to 48 (best function). Measurements were collected at 6 weeks, 3 months, 6 months and 12 months by postal questionnaire; 6 months was the primary outcome time point. The primary health outcome for economic evaluation was the quality-adjusted life-year, in accordance with National Institute of Health and Care Excellence guidelines. Results: Between 14 November 2018 and 14 March 2022, 482 participants were randomised to advice (n = 240) or advice and a programme of physiotherapy (n = 242). Participants were 34% female, with a mean age of 45 years, and treatment arms were balanced at baseline. There was not a statistically significant difference in the primary outcome between advice only and advice plus a programme of physiotherapy at 6 months for the primary intention-to-treat adjusted analysis (favours physiotherapy: 1.5, 95% confidence interval -0.3 to 3.5) or at earlier 3-month and 6-week time points on the Oxford Shoulder Instability Score (0-48; higher scores indicate better function). The probability of physiotherapy being cost-effective at a willingness-to-pay threshold of £30,000 was 0.95. Conclusions: We found little difference in the primary outcome or other secondary outcomes. Advice with additional physiotherapy sessions was found likely to be cost-effective. However, small imprecise incremental costs and quality-adjusted life-years raise questions on whether it is the best use of scarce physiotherapy resources given current service demands. Limitations: Loss to follow-up was 27%; however, the observed standard deviation was much smaller than anticipated. These changes in parameters reduced the number of participants required to observe the planned target difference of four points. Our post hoc sensitivity analysis, accounting for missing data, gives similar results. Future work: Further research should be directed towards optimising self-management strategies. Study registration: This study is registered as ISRCTN63184243. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/167/56) and is published in full in Health Technology Assessment; Vol. 28, No. 22. See the NIHR Funding and Awards website for further award information.
The shoulder dislocates (comes out of its socket joint) when the upper end of the arm bone is forced out during an injury. This common problem occurs mostly in men in their 20s and women aged over 80. After the bone is put back in its socket, most people are managed with physiotherapy. In the United Kingdom, once the bone is back in its socket, there is a range of physiotherapy provision: some hospitals offer advice, and some offer advice and a course of additional physiotherapy sessions. We compared advice alone to advice and physiotherapy for people who had a shoulder that had come out of its joint for the first time. Physiotherapy advice and additional sessions included education about the injury and exercises to move and strengthen the shoulder. When we started this project, this was the first time these two treatments had been compared. Our aim was to compare what activities the two groups could do 6 months after injury via a questionnaire. We also compared quality of life and the cost of rehabilitation at 6 weeks, 3 months, 6 months and 12 months after injury. Adults with a shoulder out of its joint and who were not having surgery were asked to take part. All adults who were eligible and consented to take part were assigned, by chance, to either a single session of advice or the same session followed by physiotherapy. Between 14 November 2018 and 14 March 2022 we collected data on 482 people, from 41 NHS sites across the UK. We found at 6 months there was little evidence that additional physiotherapy was better, when compared to advice alone. Cost-effectiveness analysis (comparing changes in costs and quality of life) suggests additional physiotherapy might provide value for money. However, the changes involved are small and uncertain.
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Análisis Costo-Beneficio , Modalidades de Fisioterapia , Luxación del Hombro , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Años de Vida Ajustados por Calidad de Vida , Luxación del Hombro/terapia , Reino UnidoRESUMEN
PURPOSE: Health care contact days-days spent receiving health care outside the home-represent an intuitive, practical, and person-centered measure of time consumed by health care. METHODS: We linked 2019 Medicare Current Beneficiary Survey and traditional Medicare claims data for community-dwelling older adults with a history of cancer. We identified contact days (ie, spent in a hospital, emergency department, skilled nursing facility, or inpatient hospice or receiving ambulatory care including an office visit, procedure, treatment, imaging, or test) and described patterns of total and ambulatory contact days. Using weighted Poisson regression models, we identified factors associated with contact days. RESULTS: We included 1,168 older adults representing 4.51 million cancer survivors (median age, 76.4 years, 52.8% women). The median (IQR) time from cancer diagnosis was 65 (27-126) months. In 2019, these adults had mean (standard deviation) total contact days of 28.4 (27.6) and ambulatory contact days of 24.2 (23.6). These included days for tests (8.0 [8.8]), imaging (3.6 [4.1]), visits with any clinicians (12.4 [11.5]), and visits with primary care clinicians (4.4 [4.7]), and nononcology specialists (7.1 [9.4]) specifically. Sixty-four percent of days with a nonvisit ambulatory service (eg, a test) were not on the same day as a clinician visit. Factors associated with more total contact days included younger age, lower income, more chronic conditions, poor self-rated health, and tendency to "go to doctor as soon as feel bad." CONCLUSION: Older adult cancer survivors spent nearly 1 month of the year receiving health care outside the home. This care was largely ambulatory, often delivered by nononcologists, and varied by factors beyond clinical characteristics. These results highlight the need to recognize patient burdens and improve survivorship care delivery, including through care coordination.
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Supervivientes de Cáncer , Humanos , Anciano , Femenino , Masculino , Anciano de 80 o más Años , Estados Unidos/epidemiología , Medicare , Neoplasias/terapiaRESUMEN
INTRODUCTION: While demographic risk factors of cancer-related financial hardships have been studied, having minor children or being single have rarely been assessed in the context of healthcare-related financial hardships. METHODS: Using data from the 2015 to 2018 National Health Interview Survey, we assessed financial hardship (material and psychological hardship; behavioral coping due to costs: delaying/foregoing care, reducing prescription costs, or skipping specialists or follow-up care) among adults aged 18-59 years with cancer (N = 2844) by minor child parenting status and family structure. In a secondary analysis, we compared this group with individuals without cancer. Using logistic regression models, we compared those with and without children aged <18 years, further distinguishing between those who were single versus one of two or more adults in the family. RESULTS: Compared to individuals from families with two or more adults/without children, single adults with children more often reported cancer-related financial hardships, for example material hardship (45.9% vs. 38.8%), and reducing prescription costs, (50.7% vs. 34.4%, adjusted OR 1.57, 95% CI 1.07-2.28). Single adults without minor children and those from families with two or more adults/with minor children also reported greater financial hardships on some dimensions. Associations were similar among those without cancer, but the overall magnitude of financial hardships was lower compared to those with cancer. CONCLUSIONS: Our findings suggest that having minor children, and being a single adult are risk factors for cancer-related financial hardship. Financial vulnerability associated with family structure should be taken into consideration in healthcare, and especially cancer care.
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Estrés Financiero , Neoplasias , Adulto , Niño , Humanos , Estructura Familiar , Neoplasias/epidemiología , Neoplasias/terapia , Encuestas y Cuestionarios , Factores de RiesgoRESUMEN
Importance: Medicare Advantage (MA) plans receive capitated per enrollee payments that create financial incentives to provide care more efficiently than traditional Medicare (TM); however, incentives could be associated with MA plans reducing use of beneficial services. Postacute care can improve functional status, but it is costly, and thus may be provided differently to Medicare beneficiaries by MA plans compared with TM. Objective: To estimate the association of MA compared with TM enrollment with postacute care use and postdischarge outcomes. Design, Setting, and Participants: This was a cohort study using Medicare data on 4613 hospitalizations among retired Ohio state employees and 2 comparison groups in 2015 and 2016. The study investigated the association of a policy change with use of postacute care and outcomes. The policy changed state retiree health benefits in Ohio from a mandatory MA plan to subsidies for either supplemental TM coverage or an MA plan. After policy implementation, approximately 75% of retired Ohio state employees switched to TM. Hospitalizations for 3 high-volume conditions that usually require postacute rehabilitation were assessed. Data from the Medicare Provider Analysis and Review files were used to identify all hospitalizations in short-term acute care hospitals. Difference-in-difference regressions were used to estimate changes for retired Ohio state employees compared with other 2015 MA enrollees in Ohio and with Kentucky public retirees who were continuously offered a mandatory MA plan. Data analyses were performed from September 1, 2019, to November 30, 2023. Exposures: Enrollment in Ohio state retiree health benefits in 2015, after which most members shifted to TM. Main Outcomes and Measures: Received care in an inpatient rehabilitation facility, skilled nursing facility, or home health, or any postacute care; the occurrence of any hospital readmission; the number of days in the community during the 30 days after hospital discharge; and mortality. Results: The study sample included 2373 hospitalizations for Ohio public retirees, 1651 hospitalizations for other Humana MA enrollees in Ohio, and 589 hospitalizations for public retirees in Kentucky. After the 2016 policy implementation, the percentage of hospitalizations covered by MA decreased by 70.1 (95% CI, -74.2 to -65.9) percentage points (pp), inpatient rehabilitation facility admissions increased by 9.7 (95% CI, 4.7 to 14.7) pp, use of only home health or skilled nursing facility care fell by 8.6 (95% CI, -14.6 to -2.6) pp, and days in the community fell by 1.6 (95% CI, -2.9 to -0.3) days for Ohio public retirees compared with other Humana MA enrollees in Ohio. There was no change in 30-day mortality or hospital readmissions; similar results were found by comparisons using Kentucky public retirees as a control group. Conclusions and Relevance: The findings of this cohort study indicate that after a change in retiree health benefits, most Ohio public retirees shifted from MA to TM and received more intensive postacute care with no significant change in measured short-term postdischarge outcomes. Future work should consider additional measures of postacute functional status over a longer follow-up period.
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Medicare Part C , Anciano , Humanos , Estados Unidos , Estudios de Cohortes , Alta del Paciente , Atención Subaguda , Cuidados PosterioresRESUMEN
OBJECTIVE: To assess the effects of an additional programme of physiotherapy in adults with a first-time traumatic shoulder dislocation compared with single session of advice, supporting materials, and option to self-refer to physiotherapy. DESIGN: Pragmatic, multicentre, randomised controlled trial (ARTISAN). SETTING AND PARTICIPANTS: Trauma research teams at 41 UK NHS Trust sites screened adults with a first time traumatic anterior shoulder dislocation confirmed radiologically, being managed non-operatively. People were excluded if they presented with both shoulders dislocated, had a neurovascular complication, or were considered for surgical management. INTERVENTIONS: One session of advice, supporting materials, and option to self-refer to physiotherapy (n=240) was assessed against the same advice and supporting materials and an additional programme of physiotherapy (n=242). Analyses were on an intention-to-treat basis with secondary per protocol analyses. MAIN OUTCOME MEASURES: The primary outcome was the Oxford shoulder instability score (a single composite measure of shoulder function), measured six months after treatment allocation. Secondary outcomes included the QuickDASH, EQ-5D-5L, and complications. RESULTS: 482 participants were recruited from 40 sites in the UK. 354 (73%) participants completed the primary outcome score (n=180 allocated to advice only, n=174 allocated to advice and physiotherapy). Participants were mostly male (66%), with a mean age of 45 years. No significant difference was noted between advice compared with advice and a programme of physiotherapy at six months for the primary intention-to-treat adjusted analysis (between group difference favouring physiotherapy 1.5 (95% confidence interval -0.3 to 3.5)) or at earlier three month and six week timepoints. Complication profiles were similar across the two groups (P>0.05). CONCLUSIONS: An additional programme of current physiotherapy is not superior to advice, supporting materials, and the option to self-refer to physiotherapy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN63184243.
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Inestabilidad de la Articulación , Luxación del Hombro , Articulación del Hombro , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Análisis Costo-Beneficio , Modalidades de Fisioterapia , Calidad de Vida , Luxación del Hombro/etiología , Luxación del Hombro/terapiaRESUMEN
BACKGROUND: Multimorbidity is associated with premature mortality and excess health care costs. The burden of multimorbidity is highest among patients with cancer, yet trends and determinants of multimorbidity over time are poorly understood. METHODS: Via Medicare claims linked to Cancer Prevention Study II data, group-based trajectory modeling was used to compare National Cancer Institute comorbidity index score trends for cancer survivors and older adults without a cancer history. Among cancer survivors, multinomial logistic regression analyses evaluated associations between demographics, health behaviors, and comorbidity trajectories. RESULTS: In 82,754 participants (mean age, 71.6 years [SD, 5.1 years]; 56.9% female), cancer survivors (n = 11,265) were more likely than older adults without a cancer history to experience the riskiest comorbidity trajectories: (1) steady, high comorbidity scores (remain high; odds ratio [OR], 1.36; 95% CI, 1.29-1.45), and (2) high scores that increased over time (start high and increase; OR, 1.51; 95% CI, 1.38-1.65). Cancer survivors who were physically active postdiagnosis were less likely to fall into these two trajectories (OR, 0.73; 95% CI, 0.64-0.84, remain high; OR, 0.42; 95% CI, 0.33-0.53, start high and increase) compared to inactive survivors. Cancer survivors with obesity were more likely to have a trajectory that started high and increased (OR, 2.83; 95% CI, 2.32-3.45 vs. normal weight), although being physically active offset some obesity-related risk. Cancer survivors who smoked postdiagnosis were also six times more likely to have trajectories that started high and increased (OR, 6.86; 95% CI, 4.41-10.66 vs. never smokers). CONCLUSIONS: Older cancer survivors are more likely to have multiple comorbidities accumulated at a faster pace than older adults without a history of cancer. Weight management, physical activity, and smoking avoidance postdiagnosis may attenuate that trend.
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Multimorbilidad , Neoplasias , Humanos , Femenino , Anciano , Estados Unidos/epidemiología , Masculino , Medicare , Conductas Relacionadas con la Salud , Neoplasias/epidemiología , Obesidad/epidemiología , DemografíaRESUMEN
BACKGROUND: The utility of codes on Medicare Advantage (MA) data to capture cancer diagnoses and treatment for cancer patients is unknown. OBJECTIVE: This study compared cancer diagnoses and treatments on MA encounter data (MA data) with the Surveillance, Epidemiology, and End-Results (SEER) data. SUBJECTS: Subjects were patients enrolled in either MA or Medicare fee-for-service (MFFS) when diagnosed with incident breast, colorectal, prostate, or lung cancer, 2015-2017, in a SEER cancer registry. MEASURES: MA data, from 2 months before to 12 months following SEER diagnosis, were reviewed to identify cancer diagnoses, surgery, chemotherapy, and radiotherapy (RT). MA data were compared with SEER to determine their sensitivity to capture cancer diagnoses and sensitivity/specificity to identify surgeries. The agreement between SEER and Medicare data regarding receipt of chemotherapy and RT was measured by Kappa statistics. A similar comparison to SEER diagnoses/treatments was made using MFFS claims to provide context for the SEER-MA comparison. RESULTS: The study included 186,449 patients, 38% in MA. MA data had 92%+ sensitivity to identify SEER cancer diagnosis and 90%+ sensitivity for cancer surgery. Specificity for surgery was >84%, except for breast cancer (52%). Kappa statistics for agreement between SEER and MA data regarding chemotherapy varied by cancer, 0.61-0.82, and for receipt of RT exceeded 0.75 for all cancers. Results observed for MFFS claims were similar to those in MA data. CONCLUSION: For 4 common cancers, MA data included most cancer diagnoses and general types of cancer treatment reported in the SEER data. More research is needed to assess additional cancers and detailed treatments.
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Neoplasias de la Mama , Neoplasias Pulmonares , Masculino , Humanos , Anciano , Estados Unidos , Medicare , Programa de VERF , Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/terapia , Neoplasias de la Mama/epidemiología , Neoplasias Pulmonares/epidemiología , Programas Controlados de Atención en SaludRESUMEN
PURPOSE: Unlike children with ALL who receive cancer care primarily at specialized cancer centers (SCCs; National Cancer Institute and/or Children's Oncology Group centers), adolescents and young adults (AYAs; 15-39 years) receive care in a variety of settings. Using population-based data, we describe where AYAs with ALL receive treatment and determine associations with overall survival (OS). METHODS: Data from the 2004 to 2018 California (CA, n = 2,283), New York (NY, n = 795), and Texas (TX, n = 955) state cancer registries were used to identify treatment setting of AYAs with newly diagnosed ALL. Multivariable Cox proportional hazards regression models evaluated associations with OS. RESULTS: Seventy percent were older than 18 years, and 65% were male. A majority in CA (63%) and TX (64%) were Hispanic while most in NY were non-Hispanic White (50%). Treatment at an SCC occurred in 48.2% (CA), 44.4% (NY), and 19.5% (TX). Across states, AYAs who were older or uninsured were less likely to receive treatment at an SCC. Treatment at an SCC was associated with superior OS in CA (hazard ratio [HR], 0.73; 95% CI, 0.63 to 0.85) and TX (HR, 0.61; 95% CI, 0.45 to 0.83); a nonsignificant association was seen in NY (HR, 0.83; 95% CI, 0.64 to 1.08). CONCLUSION: Only 20%-50% of AYA patients with ALL received frontline treatment at SCCs. Treatment of ALL at an SCC was associated with superior survival, highlighting the importance of policy efforts to improve access and reduce inequities in AYA ALL care.
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Leucemia-Linfoma Linfoblástico de Células Precursoras , Tasa de Supervivencia , Adolescente , Femenino , Humanos , Masculino , Adulto Joven , Pacientes no Asegurados , Modelos de Riesgos Proporcionales , Adulto , Leucemia-Linfoma Linfoblástico de Células Precursoras/terapiaRESUMEN
INTRODUCTION: The number of robotic-assisted hip replacement procedures has expanded globally with the intended aim of improving outcomes. Intraoperative robotic-arm systems add additional costs to total hip replacement (THR) surgery but may improve surgical precision and could contribute to diminished pain and improved function. Additionally, these systems may reduce the need for expensive revision surgery. Surgery with conventional instruments may be just as successful, quick and affordable. There is timely demand for a robust evaluation of this technology. METHODS AND ANALYSIS: The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial for Hips (RACER-Hip) is a multicentre (minimum of six UK sites), participant-assessor blinded, randomised controlled trial. 378 participants with hip osteoarthritis requiring THR will be randomised (1:1) to receive robotic-assisted THR, or THR using conventional surgical instruments. The primary outcome is the Forgotten Joint Score at 12 months post-randomisation; a patient-reported outcome measure assessing participants' awareness of their joint when undertaking daily activities. Secondary outcomes will be collected post-operatively (pain, blood loss and opioid usage) and at 3, 6, 12, 24 months, then 5 and 10 years postrandomisation (including function, pain, health-related quality of life, reoperations and satisfaction). Allocation concealment will be accomplished using a computer-based randomisation procedure on the day of surgery. Blinding methods include the use of sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will adhere to Consolidated Standards of Reporting Trials statements. ETHICS AND DISSEMINATION: The trial was approved by an ethics committee (Solihull Research Ethics Committee, 30 June 2021, IRAS: 295831). Participants will provide informed consent before agreeing to participate. Results will be disseminated using peer-reviewed journal publications, presentations at international conferences and through the use of social media. We will develop plans to disseminate to patients and public with our patient partners. TRIAL REGISTRATION NUMBER: ISRCTN13374625.
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Artroplastia de Reemplazo de Cadera , Procedimientos Quirúrgicos Robotizados , Humanos , Análisis de Costo-Efectividad , Calidad de Vida , Artroplastia de Reemplazo de Cadera/métodos , Dolor , Reino Unido , Resultado del Tratamiento , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
PURPOSE: Frequent visits to health care facilities can be time intensive and all-consuming for people with cancer. We measured health care contact days (days with healthcare contact outside the home) among decedents with advanced GI cancer and examined sources of contact days, their associations with demographic and clinical factors, and their temporal patterns over the course of illness. METHODS: We conducted a retrospective cohort study using a tumor registry and electronic medical record data for decedents with stage IV GI cancer between 2011 and 2019 in a large health care network in MN. We determined contact days from diagnosis to death using chart review. Using multivariable beta regression adjusted for sociodemographic and clinical characteristics offset by survival, we calculated adjusted estimates of contact days and determined patient-level factors associated with percentage of contact days. RESULTS: We identified 809 patients eligible for analysis (median [IQR] age at diagnosis, 65 [56-73] years). The median (IQR) overall survival was 175 (56-459) days. Patients spent a median (IQR) of 25.8% (17.4%-39.1%) of these as contact days. Of these days, 83.6% were spent on outpatient visits. In the multivariable analysis, older age, Black race, and never receiving systemic cancer-directed treatment were associated with a higher percentage of contact days. The percentage of contact days was highest in the first month after diagnosis (39.6%) and before death (32.2%), with a more moderate middle phase (U-shaped curve). CONCLUSION: Decedents with advanced GI cancer spend 1 in 4 days alive with health care contact, despite a median survival of under 6 months. This is even higher immediately postdiagnosis and near death. These findings highlight the need to understand sources of variation, benchmark appropriate care, and deliver more efficient care for this vulnerable population with limited time.
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Neoplasias Gastrointestinales , Humanos , Persona de Mediana Edad , Anciano , Estudios Retrospectivos , Neoplasias Gastrointestinales/epidemiología , Neoplasias Gastrointestinales/terapia , Atención a la SaludRESUMEN
INTRODUCTION: Critical access hospitals (CAHs) provide an opportunity to meet the needs of individuals with cancer in rural areas. Two common innovative care delivery methods include the use of traveling oncologists and teleoncology. It is important to understand the availability and organization of cancer care services in CAHs due to the growing population with cancer and expected declines in oncology workforce in rural areas. METHODS: Stratified random sampling was used to generate a sample of 50 CAHs from each of the four U.S. Census Bureau-designated regions resulting in a total sample of 200 facilities. Analyses were conducted from 135 CAH respondents to understand the availability of cancer care services and organization of cancer care across CAHs. RESULTS: Almost all CAHs (95%) provided at least one cancer screening or diagnostic service. Forty-six percent of CAHs reported providing at least one component of cancer treatment (chemotherapy, radiation, or surgery) at their facility. CAHs that offered cancer treatment reported a wide range of health care staff involvement, including 34% of respondents reporting involvement of a local oncologist, 38% reporting involvement of a visiting oncologist, and 28% reporting involvement of a non-local oncologist using telemedicine. CONCLUSION: Growing disparities within rural areas emphasize the importance of ensuring access to timely screening and guideline-recommended treatment for cancer in rural communities. These data demonstrated that CAHs are addressing the growing need through a variety of approaches including the use of innovative models that utilize non-local providers and telemedicine to expand access to crucial services for rural residents with cancer.
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Accesibilidad a los Servicios de Salud , Neoplasias , Humanos , Hospitales , Neoplasias/diagnóstico , Neoplasias/epidemiología , Neoplasias/terapiaRESUMEN
INTRODUCTION: Robotic-assisted knee replacement systems have been introduced to healthcare services worldwide in an effort to improve clinical outcomes for people, although high-quality evidence that they are clinically, or cost-effective remains sparse. Robotic-arm systems may improve surgical accuracy and could contribute to reduced pain, improved function and lower overall cost of total knee replacement (TKR) surgery. However, TKR with conventional instruments may be just as effective and may be quicker and cheaper. There is a need for a robust evaluation of this technology, including cost-effectiveness analyses using both within-trial and modelling approaches. This trial will compare robotic-assisted against conventional TKR to provide high-quality evidence on whether robotic-assisted knee replacement is beneficial to patients and cost-effective for healthcare systems. METHODS AND ANALYSIS: The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial-Knee is a multicentre, participant-assessor blinded, randomised controlled trial to evaluate the clinical and cost-effectiveness of robotic-assisted TKR compared with TKR using conventional instruments. A total of 332 participants will be randomised (1:1) to provide 90% power for a 12-point difference in the primary outcome measure; the Forgotten Joint Score at 12 months postrandomisation. Allocation concealment will be achieved using computer-based randomisation performed on the day of surgery and methods for blinding will include sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will be reported in line with the Consolidated Standards of Reporting Trials statement. A parallel study will collect data on the learning effects associated with robotic-arm systems. ETHICS AND DISSEMINATION: The trial has been approved by an ethics committee for patient participation (East Midlands-Nottingham 2 Research Ethics Committee, 29 July 2020. NRES number: 20/EM/0159). All results from the study will be disseminated using peer-reviewed publications, presentations at international conferences, lay summaries and social media as appropriate. TRIAL REGISTRATION NUMBER: ISRCTN27624068.
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Artroplastia de Reemplazo de Rodilla , Procedimientos Quirúrgicos Robotizados , Humanos , Análisis de Costo-Efectividad , Articulación de la Rodilla , Artroplastia de Reemplazo de Rodilla/métodos , Dolor , Análisis Costo-Beneficio , Resultado del Tratamiento , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
BACKGROUND: Among adults with cancer, malnutrition is associated with decreased treatment completion, more treatment harms and use of health care, and worse short-term survival. To inform the National Institutes of Health Pathways to Prevention workshop, "Nutrition as Prevention for Improved Cancer Health Outcomes," this systematic review examined the evidence for the effectiveness of providing nutrition interventions before or during cancer therapy to improve outcomes of cancer treatment. METHODS: We identified randomized controlled trials enrolling at least 50 participants published from 2000 through July 2022. We provide a detailed evidence map for included studies and grouped studies by broad intervention and cancer types. We conducted risk of bias (RoB) and qualitative descriptions of outcomes for intervention and cancer types with a larger volume of literature. RESULTS: From 9798 unique references, 206 randomized controlled trials from 219 publications met the inclusion criteria. Studies primarily focused on nonvitamin or mineral dietary supplements, nutrition support, and route or timing of inpatient nutrition interventions for gastrointestinal or head and neck cancers. Most studies evaluated changes in body weight or composition, adverse events from cancer treatment, length of hospital stay, or quality of life. Few studies were conducted within the United States. Among intervention and cancer types with a high volume of literature (n = 114), 49% (n = 56) were assessed as high RoB. Higher-quality studies (low or medium RoB) reported mixed results on the effect of nutrition interventions across cancer and treatment-related outcomes. CONCLUSIONS: Methodological limitations of nutrition intervention studies surrounding cancer treatment impair translation of findings into clinical practice or guidelines.
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Neoplasias de Cabeza y Cuello , Calidad de Vida , Adulto , Humanos , Dieta , Peso CorporalRESUMEN
The aim of this study was to compare the longer-term outcomes of operatively and nonoperatively managed patients treated with a removable brace (fixed-angle removable orthosis) or a plaster cast immobilization for an acute ankle fracture. This is a secondary analysis of a multicentre randomized controlled trial comparing adults with an acute ankle fracture, initially managed either by operative or nonoperative care. Patients were randomly allocated to receive either a cast immobilization or a fixed-angle removable orthosis (removable brace). Data were collected on baseline characteristics, ankle function, quality of life, and complications. The Olerud-Molander Ankle Score (OMAS) was the primary outcome which was used to measure the participant's ankle function. The primary endpoint was at 16 weeks, with longer-term follow-up at 24 weeks and two years. Overall, 436 patients (65%) completed the final two-year follow-up. The mean difference in OMAS at two years was -0.3 points favouring the plaster cast (95% confidence interval -3.9 to 3.4), indicating no statistically significant difference between the interventions. There was no evidence of differences in patient quality of life (measured using the EuroQol five-dimension five-level questionnaire) or Disability Rating Index. This study demonstrated that patients treated with a removable brace had similar outcomes to those treated with a plaster cast in the first two years after injury. A removable brace is an effective alternative to traditional immobilization in a plaster cast for patients with an ankle fracture.