Your browser doesn't support javascript.
Show: 20 | 50 | 100
Results 1 - 20 de 71.206
Filter
Add filters

Year range
1.
J Clin Sleep Med ; 18(3): 739-750, 2022 Mar 01.
Article in English | MEDLINE | ID: mdl-34608859

ABSTRACT

STUDY OBJECTIVES: Mandibular advancement devices (MADs) are a noninvasive treatment option for patients with obstructive sleep apnea (OSA) and act by increasing the upper airway volume. However, the exact therapeutic mechanism of action remains unclear. The aim of this study was to assess MAD mechanisms using functional imaging that combines imaging techniques and computational fluid dynamics and assess associations with treatment outcome. METHODS: One hundred patients with OSA were prospectively included and treated with a custom-made MAD at a fixed 75% protrusion. A low-dose computed tomography scan was made with and without MADs for computational fluid dynamics analysis. Patients underwent a baseline and 3-month follow-up polysomnography to evaluate treatment efficacy. A reduction in apnea-hypopnea index ≥ 50% defined treatment response. RESULTS: Overall, 71 patients completed both 3-month follow-up polysomnography and low-dose computed tomography scan with computational fluid dynamics analysis. MAD treatment significantly reduced the apnea-hypopnea index (16.5 [10.4-23.6] events/h to 9.1 [3.9-16.4] events/h; P < .001, median [quartile 1-quartile 3]) and significantly increased the total upper airway volume (8.6 [5.4-12.8] cm3 vs 10.7 [6.4-15.4] cm3; P = .003), especially the velopharyngeal volume (2.1 [0.5-4.1] cm3 vs 3.3 [1.8-6.0] cm3; P < .001). However, subanalyses in responders and nonresponders only showed a significant increase in the total upper airway volume in responders, not in nonresponders. CONCLUSIONS: MAD acts by increasing the total upper airway volume, predominantly due to an increase in the velopharyngeal volume. Responders showed a significant increase in the total upper airway volume with MAD treatment, while there was no significant increase in nonresponders. Findings add evidence to implement functional imaging using computational fluid dynamics in routine MAD outcome prediction. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea; URL: https://clinicaltrials.gov/ct2/show/NCT01532050; Identifier: NCT01532050. CITATION: Van Gaver H, Op de Beeck S, Dieltjens M, et al. Functional imaging improves patient selection for mandibular advancement device treatment outcome in sleep-disordered breathing: a prospective study. J Clin Sleep Med. 2022;18(3):739-750.


Subject(s)
Mandibular Advancement , Sleep Apnea, Obstructive , Humans , Occlusal Splints , Patient Selection , Prospective Studies , Sleep Apnea, Obstructive/diagnostic imaging , Sleep Apnea, Obstructive/therapy , Treatment Outcome
2.
Stroke ; 53(1): 87-99, 2022 01.
Article in English | MEDLINE | ID: mdl-34634926

ABSTRACT

BACKGROUND AND PURPOSE: The net benefit of carotid endarterectomy (CEA) is determined partly by the risk of procedural stroke or death. Current guidelines recommend CEA if 30-day risks are <6% for symptomatic stenosis and <3% for asymptomatic stenosis. We aimed to identify prediction models for procedural stroke or death after CEA and to externally validate these models in a large registry of patients from the United States. METHODS: We conducted a systematic search in MEDLINE and EMBASE for prediction models of procedural outcomes after CEA. We validated these models with data from patients who underwent CEA in the American College of Surgeons National Surgical Quality Improvement Program (2011-2017). We assessed discrimination using C statistics and calibration graphically. We determined the number of patients with predicted risks that exceeded recommended thresholds of procedural risks to perform CEA. RESULTS: After screening 788 reports, 15 studies describing 17 prediction models were included. Nine were developed in populations including both asymptomatic and symptomatic patients, 2 in symptomatic and 5 in asymptomatic populations. In the external validation cohort of 26 293 patients who underwent CEA, 702 (2.7%) developed a stroke or died within 30-days. C statistics varied between 0.52 and 0.64 using all patients, between 0.51 and 0.59 using symptomatic patients, and between 0.49 to 0.58 using asymptomatic patients. The Ontario Carotid Endarterectomy Registry model that included symptomatic status, diabetes, heart failure, and contralateral occlusion as predictors, had C statistic of 0.64 and the best concordance between predicted and observed risks. This model identified 4.5% of symptomatic and 2.1% of asymptomatic patients with procedural risks that exceeded recommended thresholds. CONCLUSIONS: Of the 17 externally validated prediction models, the Ontario Carotid Endarterectomy Registry risk model had most reliable predictions of procedural stroke or death after CEA and can inform patients about procedural hazards and help focus CEA toward patients who would benefit most from it.


Subject(s)
Carotid Stenosis/surgery , Clinical Trials as Topic/standards , Endarterectomy, Carotid/standards , Models, Theoretical , Patient Selection , Registries/standards , Carotid Stenosis/diagnosis , Endarterectomy, Carotid/methods , Humans , Predictive Value of Tests , Risk Assessment/methods , Risk Assessment/standards
3.
Braz J Med Biol Res ; 56: e12326, 2023.
Article in English | MEDLINE | ID: mdl-36722659

ABSTRACT

There is a high demand for stroke rehabilitation in the Brazilian public health system, but most studies that have addressed rehabilitation for unilateral spatial neglect (USN) after stroke have been performed in high-income countries. Therefore, the aim of this study was to analyze USN patient recruitment in a multicenter noninvasive brain stimulation clinical trial performed in Brazil and to provide study design recommendations for future studies. We evaluated the reasons for exclusion of patients from a multicenter, randomized, double-blinded clinical trial of rehabilitation of USN patients after stroke. Clinical and demographic variables were compared between the included and excluded patients. A descriptive statistical analysis was performed. Only 173 of the 1953 potential neglect patients (8.8%) passed the initial screening. After screening evaluation, 87/173 patients (50.3%) were excluded for clinical reasons. Cognitive impairment led to the exclusion of 21/87 patients (24.1%). Low socioeconomic status led to the exclusion of 37/173 patients (21.4%). Difficulty obtaining transportation to access treatment was the most common reason for their exclusion (16/37 patients, 43.3%). The analyzed Brazilian institutions have potential for conducting studies of USN. The recruitment of stroke survivors with USN was restricted by the study design and limited financial support. A history of cognitive impairment, intracranial stenting or craniectomy, and lack of transportation were the most common barriers to participating in a multicenter noninvasive brain stimulation trial among patients with USN after stroke.


Subject(s)
Neurological Rehabilitation , Stroke Rehabilitation , Stroke , Humans , Patient Selection , Brazil , Stroke/complications
4.
JBJS Rev ; 11(1)2023 Jan 01.
Article in English | MEDLINE | ID: mdl-36722826

ABSTRACT

¼: Bilateral total knee arthroplasty (BTKA) is an effective surgical treatment for bilateral knee arthritis and can be performed as a simultaneous surgery under a single anesthetic setting or as staged surgeries on separate days. ¼: Appropriate patient selection is important for simultaneous BTKA with several factors coming into consideration such as age, comorbidities, work status, and home support, among others. ¼: While simultaneous BTKA is safe when performed on appropriately selected patients, current evidence suggests that the risk of complications after simultaneous BTKA remains higher than for staged BTKA. ¼: When staged surgery is preferred, current evidence indicates that complication risks are minimized if the 2 knees are staged at least 3 months apart. ¼: Simultaneous BTKA is the economically advantageous treatment option relative to staged BTKA, primarily because of shorter total operative time and total hospital stay.


Subject(s)
Arthritis , Arthroplasty, Replacement, Knee , Humans , Infant , Arthroplasty, Replacement, Knee/adverse effects , Length of Stay , Operative Time , Patient Selection
6.
Fluids Barriers CNS ; 20(1): 7, 2023 Jan 26.
Article in English | MEDLINE | ID: mdl-36703181

ABSTRACT

BACKGROUND: Idiopathic normal pressure hydrocephalus (iNPH) is a progressive and partially reversible form of dementia, characterized by impaired interactions between multiple brain regions. Because of the presence of comorbidities and a lack of accurate diagnostic and prognostic biomarkers, only a minority of patients receives disease-specific treatment. Recently, resting-state functional-magnetic resonance imaging (rs-fMRI) has demonstrated functional connectivity alterations in inter-hemispheric, frontal, occipital, default-mode (DMN) and motor network (MN) circuits. Herein, we report our experience in a cohort of iNPH patients that underwent cerebrospinal fluid (CSF) dynamics evaluation and rs-fMRI. The study aimed to identify functional circuits related to iNPH and explore the relationship between DMN and MN recordings and clinical modifications before and after infusion and tap test, trying to understand iNPH pathophysiology and to predict the best responders to ventriculoperitoneal shunt (VPS) implant. METHODS: We prospectively collected data regarding clinical assessment, neuroradiological findings, lumbar infusion and tap test of thirty-two iNPH patients who underwent VPS implant. Rs-fMRI was performed using MELODIC-ICA both before and after the tap test. Rs-fMRI data of thirty healthy subjects were also recorded. RESULTS: At the baseline, reduced z-DMN and z-MN scores were recorded in the iNPH cohort compared with controls. Higher z-scores were recorded in more impaired patients. Both z-scores significantly improved after the tap test except in subjects with a low resistance to outflow value and without a significant clinical improvement after the test. A statistically significant difference in mean MN connectivity scores for tap test responders and non-responders was demonstrated both before (p = 0.0236) and after the test (p = 0.00137). A statistically significant main effect of the tap test on DMN connectivity after CSF subtraction was recorded (p = 0.038). CONCLUSIONS: Our results suggest the presence of a partially reversible plasticity functional mechanism in DMN and MN. Low values compensate for the initial stages of the disease, while higher values of z-DMN were recorded in older patients with a longer duration of symptoms, suggesting an exhausted plasticity compensation. The standardization of this technique could play a role as a non-invasive biomarker in iNPH disease, suggesting the right time for surgery. Trial Registration Prot. IRB 090/2021.


Subject(s)
Hydrocephalus, Normal Pressure , Humans , Aged , Patient Selection , Hydrocephalus, Normal Pressure/cerebrospinal fluid , Brain/pathology , Ventriculoperitoneal Shunt , Magnetic Resonance Imaging
7.
Spine (Phila Pa 1976) ; 48(4): 278-287, 2023 Feb 15.
Article in English | MEDLINE | ID: mdl-36692157

ABSTRACT

STUDY DESIGN/SETTING: Systematic review. OBJECTIVE: The primary purpose was to propose patient selection criteria and perioperative best practices that can serve as a starting point for an ambulatory lumbar fusion program. The secondary purpose was to review patient-reported outcomes (PROs) after ambulatory lumbar fusion. SUMMARY OF BACKGROUND: As healthcare costs rise, there is an increasing emphasis on cost saving strategies (i.e. outpatient/ambulatory surgeries). Lumbar fusion procedures remain a largely inpatient surgery. Early studies have shown that fusion procedures can be safely preformed in an outpatient setting but no review has summarized these findings and best practices. MATERIALS AND METHODS: This study was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. PubMed/MEDLINE, The Cochrane Library, and Embase were searched. The following data were collected: (1) study design; (2) number of participants; (3) patient population; (4) procedure types; (5) procedure setting; (6) inclusion criteria; (7) protocols; (8) adverse events; (9) PROs; and (10) associations between patient/surgical factors, setting, and outcomes. RESULTS: The search yielded 20 publications. The following selection criteria for ambulatory lumbar fusion were identified: age below 70, minimal comorbidities, low/normal body mass index, no tobacco use, and no opioid use. The perioperative protocol can include a multimodal analgesic regimen. The patient should be observed for at least three hours after surgery. The patient should not be discharged without an alertness check and a neurological examination. Patients experienced significant improvements in PROs after ambulatory lumbar fusion; similarly, when compared to an inpatient group, ambulatory lumbar fusion patients experienced a comparable or superior improvement in PROs. CONCLUSION: There are two critical issues surrounding ambulatory lumbar fusion: (1) Who is the ideal patient, and (2) What needs to be done to enable expedited discharge? We believe this review will provide a foundation to assist surgeons in making decisions regarding the performance of lumbar fusion on an ambulatory basis. LEVEL OF EVIDENCE: Level III.


Subject(s)
Lumbosacral Region , Spinal Fusion , Humans , Ambulatory Surgical Procedures/methods , Inpatients , Lumbosacral Region/surgery , Outpatients , Patient Selection , Spinal Fusion/methods
9.
Curr Oncol ; 30(1): 184-195, 2022 Dec 23.
Article in English | MEDLINE | ID: mdl-36661664

ABSTRACT

Radiotherapy omission is increasingly considered for selected patients with early-stage breast cancer. However, with emerging data on the safety and efficacy of radiotherapy de-escalation with partial breast irradiation and accelerated treatment regimens for low-risk breast cancer, it is necessary to move beyond an all-or-nothing approach. Here, we review existing data for radiotherapy omission, including the use of age, tumor subtype, and multigene profiling assays for selecting low-risk patients for whom omission is a reasonable strategy. We review data for de-escalated radiotherapy, including partial breast irradiation and acceleration of treatment time, emphasizing these regimens' decreasing biological and financial toxicities. Lastly, we review evidence of omission of endocrine therapy. We emphasize ongoing research to define patient selection, treatment delivery, and toxicity outcomes for de-escalated adjuvant therapies better and highlight future directions.


Subject(s)
Breast Neoplasms , Humans , Female , Breast Neoplasms/pathology , Mastectomy, Segmental , Combined Modality Therapy , Patient Selection
10.
Drug Des Devel Ther ; 16: 4449-4461, 2022.
Article in English | MEDLINE | ID: mdl-36601368

ABSTRACT

Losses of 5-10% or more of initial body weight are associated with improvements in obesity-related comorbidities. However, attaining and sustaining this level of weight loss is challenging. The novel anti-obesity medication semaglutide 2.4 mg injected subcutaneously once weekly as an adjunct to a reduced-calorie diet and physical activity helps patients achieve average losses of 9.6-17.4% of initial body weight at week 68, as well as improvements in cardiometabolic and psychosocial indices. Despite these average benefits, prescribers should carefully assess the suitability of patients for this medication. In this paper, we discuss considerations for the selection of individuals who are candidates for semaglutide and special considerations related to the use of this medication. These include its efficacy and safety, as well as its contraindications, potential adverse effects, management of comorbidities and drug interactions, insurance coverage and cost, and patient preferences.


Subject(s)
Diabetes Mellitus, Type 2 , Hypoglycemic Agents , Humans , Adult , Hypoglycemic Agents/adverse effects , Diabetes Mellitus, Type 2/drug therapy , Patient Selection , Body Weight
11.
BMJ Open ; 12(12): e067656, 2022 12 09.
Article in English | MEDLINE | ID: mdl-36600344

ABSTRACT

OBJECTIVES: To describe the extent to which pragmatic trials underachieved or overachieved their target sample sizes, examine explanations and identify characteristics associated with under-recruitment and over-recruitment. STUDY DESIGN AND SETTING: Secondary analysis of an existing database of primary trial reports published during 2014-2019, registered in ClinicalTrials.gov, self-labelled as pragmatic and with target and achieved sample sizes available. RESULTS: Of 372 eligible trials, the prevalence of under-recruitment (achieving <90% of target sample size) was 71 (19.1%) and of over-recruitment (>110% of target) was 87 (23.4%). Under-recruiting trials commonly acknowledged that they did not achieve their targets (51, 71.8%), with the majority providing an explanation, but only 11 (12.6%) over-recruiting trials acknowledged recruitment excess. The prevalence of under-recruitment in individually randomised versus cluster randomised trials was 41 (17.0%) and 30 (22.9%), respectively; prevalence of over-recruitment was 39 (16.2%) vs 48 (36.7%), respectively. Overall, 101 025 participants were recruited to trials that did not achieve at least 90% of their target sample size. When considering trials with over-recruitment, the total number of participants recruited in excess of the target was a median (Q1-Q3) 319 (75-1478) per trial for an overall total of 555 309 more participants than targeted. In multinomial logistic regression, cluster randomisation and lower journal impact factor were significantly associated with both under-recruitment and over-recruitment, while using exclusively routinely collected data and educational/behavioural interventions were significantly associated with over-recruitment; we were unable to detect significant associations with obtaining consent, publication year, country of recruitment or public engagement. CONCLUSIONS: A clear explanation for under-recruitment or over-recruitment in pragmatic trials should be provided to encourage transparency in research, and to inform recruitment to future trials with comparable designs. The issues and ethical implications of over-recruitment should be more widely recognised by trialists, particularly when designing cluster randomised trials.


Subject(s)
Patient Selection , Pragmatic Clinical Trials as Topic , Humans , Databases, Factual , Prevalence , Publications , Sample Size
12.
Int J Med Inform ; 170: 104955, 2023 Feb.
Article in English | MEDLINE | ID: mdl-36565546

ABSTRACT

INTRODUCTION: Research participants have a growing expectation for transparency with their collected information; however, there is little guidance on participant preferences for receiving health information and how researchers should return this information to participants. METHODS: We conducted a cross-sectional online survey with a representative sample of 502 participants in the United States. Participants were asked about their preferences for receiving, sharing, and the formatting of health information collected for research purposes. RESULTS: Most participants wanted their health information returned (84 %) to use it for their own knowledge and to manage their own health. Email was the most preferred format for receiving health data (67 %), followed by online website (44 %), and/or paper copy (32 %). Data format preferences varied by age, education, financial resources, subjective numeracy, and health literacy. Around one third of Generation Z (25 %), Millennials (30 %), and Generation X (29 %) participants preferred to receive their health information with a mobile app. In contrast, very few Baby Boomers (12 %) and none from the Silent Generation preferred the mobile app format. Having a paper copy of the data was preferred by 38 % of participants without a college degree compared to those with a college degree. Preferences were highest for sharing all health information with doctors and nurses (77 %), and some information with friends and family (66 %). CONCLUSION: Study findings support returning research information to participants in multiple formats, including email, online websites, and paper copy. Preferences for whom to share information with varied by stakeholders and by sociodemographic characteristics. Researchers should offer multiple formats to participants and tailor data sharing options to participants' preferences. Future research should further explore combinations of individual characteristics that may further influence data sharing and format preferences.


Subject(s)
Health Literacy , Information Dissemination , Humans , Cross-Sectional Studies , Information Dissemination/methods , United States , Patient Reported Outcome Measures , Patient Selection , Trust
13.
J Plant Physiol ; 280: 153895, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36529076

ABSTRACT

Wheat is one of the most important cereal crops, representing a fundamental source of calories and protein for the global human population. Drought stress (DS) is a widespread phenomenon, already affecting large wheat-growing areas worldwide, and a major threat for cereal productivity, resulting in consistent losses in average grain yield (GY). Climate change is projected to exacerbate DS incidence and severity by increasing temperatures and changing rainfall patterns. Estimating that wheat production has to substantially increase to guarantee food security to a demographically expanding human population, the need for breeding programs focused on improving wheat drought resistance is manifest. Drought occurrence, in terms of time of appearance, duration, frequency, and severity, along the plant's life cycle varies significantly among different environments and different agricultural years, making it difficult to identify reliable phenological, morphological, and functional traits to be used as effective breeding tools. The situation is further complicated by the presence of confounding factors, e.g., other concomitant abiotic stresses, in an open-field context. Consequently, the relationship between morpho-functional traits and GY under water deficit is often contradictory; moreover, controversies have emerged not only on which traits are to be preferred, but also on how one specific trait should be desired. In this review, we attempt to identify the possible causes of these disputes and propose the most suitable selection criteria in different target environments and, thus, the best trait combinations for breeders in different drought contexts. In fact, an environment-oriented approach could be a valuable solution to overcome controversies in identifying the proper selection criteria for improving wheat drought resistance.


Subject(s)
Triticum , Humans , Triticum/genetics , Patient Selection , Plant Breeding/methods , Edible Grain/genetics , Droughts
15.
J Natl Cancer Inst Monogr ; 2022(60): 125-134, 2022 12 15.
Article in English | MEDLINE | ID: mdl-36519817

ABSTRACT

The workshop "Engaging Older Adults in Cancer Clinical Trials Conducted in the NCI Clinical Trials Network: Challenges and Opportunities" included a Patient Stakeholder Workgroup that explored the needs and concerns of older adults with cancer regarding clinical trials. To accomplish this, the workgroup conducted patient focus groups in which participants were interviewed, recorded conversations were analyzed and coded, and salient themes were identified. The focus groups identified general barriers to accrual such as complex consent forms, general communication, restrictive eligibility, nonreferrals, patient costs, cultural insensitivity, limited accessibility in community settings, and transportation issues. They also identified the influence of knowledgeable information presenters, improved care, family or caregiver support, and the desire to help others as drivers or reasons to participate in clinical trials. The workshop concluded that multi-level interventions could be used to increase the accrual of older adults to National Cancer Institute clinical trials as well as others.


Subject(s)
Clinical Trials as Topic , Neoplasms , Patient Selection , Aged , Humans , Focus Groups , National Cancer Institute (U.S.) , Neoplasms/therapy , United States
16.
J Natl Cancer Inst Monogr ; 2022(60): 117-124, 2022 12 15.
Article in English | MEDLINE | ID: mdl-36519815

ABSTRACT

In April 2021, the National Cancer Institute (NCI) Division of Cancer Prevention collaborated with the NCI Division of Cancer Treatment and Diagnosis to produce a virtual workshop that developed recommendations for enhancing NCI-sponsored clinical trial accrual of older adults. Prior to the workshop, a multidisciplinary group of stakeholders (eg, community oncologists, advanced practice practitioners, clinic and research staff, and patient advocates) gathered information related to accrual of older adults to clinical trials from the literature. Subsequently, a survey was conducted to detail NCI Community Oncology Research Program members' perspective on accrual barriers for this population; 305 individuals responded to the survey. Barriers to clinical trial accruals included comorbidity-attributed trial ineligibility, transportation and time issues, concern that the proposed regimen is too toxic for older adults, patient or family caregiver declined participation, and lack of trials relevant to older patients. Identified solutions included broadening clinical trial inclusion criteria, increasing the number of clinical trials specifically designed for older adults, simplifying consent forms, improving recruitment materials for older adults and their families, and facilitating transportation vouchers. At the workshop, participants, including stakeholders, used prior literature and survey results to develop recommendations, including interventions to address clinician bias, implement geriatric assessment, and promote clinician and staff engagement as mechanisms to improve accrual of older adults to clinical trials.


Subject(s)
Clinical Trials as Topic , Neoplasms , Patient Selection , Aged , Humans , National Cancer Institute (U.S.) , Neoplasms/therapy , United States
17.
J Natl Cancer Inst Monogr ; 2022(60): 135-141, 2022 12 15.
Article in English | MEDLINE | ID: mdl-36519818

ABSTRACT

Although adults aged 65 years or older make up a strong majority of cancer patients, their underrepresentation in cancer clinical trials leads to the lack of representative data to guide evidence-based therapeutic decisions in this patient population. The Trial Design Working Group, convened as part of the workshop titled, Engaging Older Adults in the National Cancer Institute Clinical Trials Network: Challenges and Opportunities, recommended study designs and design elements that could improve accrual of older adults in National Cancer Institute-funded clinical trials. These include trials that are specifically designed to enroll older adults, trials that include a cohort of older patients (parallel cohort, stratified cohort, or embedded cohort), and trials with pragmatic design elements to facilitate enrollment of older adults. This manuscript provides brief descriptions of the recommended designs, examples of successful trials, and considerations for implementation of these designs. As with any clinical trial, the scientific questions and trial objectives should drive the study design, the selection of endpoints and intervention, and eligibility criteria. When designing trials that include older adults, the heterogeneity of fitness levels is an important consideration as fitness can influence accrual rates and outcomes. Appropriately incorporating geriatric assessments can help identify the optimal subset of older patients for inclusion and minimize selection bias. Incorporating pragmatic design elements to reduce the burden on trial participants as well as on accruing sites and retaining essential elements to ensure that the main goal of the trial can be accomplished can enhance enrollment without compromising the integrity of trials.


Subject(s)
Clinical Trials as Topic , Neoplasms , Patient Selection , Aged , Humans , Eligibility Determination , National Cancer Institute (U.S.) , Neoplasms/therapy , Research Design , United States
18.
J Natl Cancer Inst Monogr ; 2022(60): 111-116, 2022 12 15.
Article in English | MEDLINE | ID: mdl-36519819

ABSTRACT

BACKGROUND: Older adults are a large and growing proportion of cancer cases in the United States, but concerns persist about whether older adults are adequately represented in the cancer clinical trials that test new options for treatment and cancer care. METHODS: This paper describes adult patient enrollments by age group to the National Cancer Institute's National Clinical Trials Network (NCTN) from 2016 to 2021, compares patient enrollment by age with the estimated incident cancer population across cancer types, and explores possible associations between patient age and patient race, ethnicity, and sex. RESULTS: This analysis found that patients aged 18 to 69 years were overrepresented in NCTN trials, whereas patients aged 70 years and older were underrepresented compared with the estimated incident cancer population. Underrepresentation of older patients was seen across cancer types. Older patients who enrolled to NCTN trials were more likely to be non-Hispanic White than the estimated incident cancer population. CONCLUSIONS: Compared with earlier analyses, NCTN trials are enrolling greater proportions of older adults, primarily driven by higher enrollment among patients aged 65 to 74 years. There is still significant room for improvement, however, especially among patients aged 75 years and older. Additionally, patient demographics should not be viewed in isolation: older Hispanic patients, for instance, were particularly underrepresented among patients enrolled to NCTN trials. The intersection between trial enrollment and age, race, and ethnicity warrants further study so that more targeted enrollment enhancement efforts can be developed that enhance trial diversity across demographic groups.


Subject(s)
Clinical Trials as Topic , Neoplasms , Patient Selection , Aged , Humans , National Cancer Institute (U.S.) , Neoplasms/epidemiology , Neoplasms/therapy , United States/epidemiology , Adolescent , Young Adult , Adult , Middle Aged
19.
Nat Rev Urol ; 20(1): 8, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36517646
20.
Best Pract Res Clin Haematol ; 35(4): 101406, 2022 12.
Article in English | MEDLINE | ID: mdl-36517123

ABSTRACT

Patients with higher-risk myelodysplastic syndromes (HR-MDS) have poor survival and are in need of more effective therapy options. Hypomethylating agents (HMAs) are the current standard of care and are being studied in combination with a number of novel therapies. Recent evidence, however, has delivered sub-optimal results, prompting the need to revisit patient selection criteria, treatment schedules, and clinical endpoints to better inform future studies and steer endpoints towards those that are clinically meaningful to patients.


Subject(s)
Leukemia, Myeloid, Acute , Myelodysplastic Syndromes , Humans , Antimetabolites, Antineoplastic/therapeutic use , Azacitidine/therapeutic use , Leukemia, Myeloid, Acute/drug therapy , Myelodysplastic Syndromes/therapy , Myelodysplastic Syndromes/drug therapy , Patient Selection , Clinical Trials as Topic
SELECTION OF CITATIONS
SEARCH DETAIL