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1.
JAMA Oncol ; 2024 Jun 13.
Artigo em Inglês | MEDLINE | ID: mdl-38869885

RESUMO

Importance: Patients with acute myeloid leukemia (AML) recognize days spent at home (home time) vs in a hospital or nursing facility as an important factor in treatment decision making. No study has adequately described home time among older adults with AML. Objective: To describe home time among older adults with AML (aged ≥66 years) and compare home time between 2 common treatments: anthracycline-based chemotherapy and hypomethylating agents (HMAs). Design, Setting, and Participants: A cohort of adults aged 66 years or older with a new diagnosis of AML from the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database in 2004 to 2016 was identified. Individuals were stratified into anthracycline-based therapy, HMAs, or chemotherapy, not otherwise specified (NOS) using claims. Main Outcomes and Measures: The primary outcome was home time, quantified by subtracting the total number of person-days spent in hospitals and nursing facilities from the number of person-days survived and dividing by total person-days. A weighted multinomial regression model with stabilized inverse probability of treatment weighting to estimate adjusted home time was used. Results: The cohort included 7946 patients with AML: 2824 (35.5%) received anthracyclines, 2542 (32.0%) HMAs, and 2580 (32.5%) were classified as chemotherapy, NOS. Median (IQR) survival was 11.0 (5.0-27.0) months for those receiving anthracyclines and 8.0 (3.0-17.0) months for those receiving HMAs. Adjusted home time for all patients in the first year was 52.4%. Home time was highest among patients receiving HMAs (60.8%) followed by those receiving anthracyclines (51.9%). Despite having a shorter median survival, patients receiving HMAs had more total days at home and 33 more days at home in the first year on average than patients receiving anthracyclines (222 vs 189). Conclusions and Relevance: This retrospective study of older adults with AML using SEER-Medicare data and propensity score weighting suggests that the additional survival afforded by receiving anthracycline-based therapy was entirely offset by admission to the hospital or to nursing facilities.

2.
J Geriatr Oncol ; 15(3): 101740, 2024 04.
Artigo em Inglês | MEDLINE | ID: mdl-38513534

RESUMO

INTRODUCTION: Studies about clinician acceptability of integrative palliative care interventions in the inpatient and outpatient cancer settings are limited. In this study, we examined clinician acceptability of a NIH-funded interdisciplinary PAlliative and Supportive Care inTervention (PACT) for older adults with acute myeloid leukemia (AML) and their care partners that transcends both inpatient and outpatient settings. MATERIALS AND METHODS: Data was collected using semi-structured interviews with clinicians who were directly involved in PACT. The domains of the Theoretical Framework of Acceptability were used to guide the qualitative analysis. RESULTS: The clinicians consisted of occupational therapists (37%), physical therapists (25%), registered nurses (25%), and a clinical rehabilitation manager (13%). Five themes were identified in the thematic analysis: (1) Emotions and affect towards the intervention, (2) Intervention coherence and self-efficacy, (3) Barriers, burden, and opportunity costs of delivering the intervention, (4) Usefulness and effectiveness of the intervention, and (5) Recommendations to improve intervention delivery. DISCUSSION: All clinicians found the PACT intervention highly acceptable and expressed the positive impact of the intervention on job fulfillment and satisfaction. Our findings provide evidence to inform the delivery and implementation of future large scale integrative palliative care intervention trials.


Assuntos
Cuidadores , Leucemia Mieloide Aguda , Humanos , Idoso , Leucemia Mieloide Aguda/terapia , Cuidados Paliativos
3.
Support Care Cancer ; 32(3): 197, 2024 Feb 28.
Artigo em Inglês | MEDLINE | ID: mdl-38416230

RESUMO

PURPOSE: Treatment decision-making for older adults with acute myeloid leukemia (AML) is complex and preference-sensitive. We sought to understand the patient experience of treatment decision-making to identify specific challenges in shared decision-making to improve clinical care and to inform the development of directed interventions. METHODS: We conducted in-depth interviews with newly diagnosed older (≥ 60 years) adults with AML and their caregivers following a semi-structured interview guide at a public safety net academic hospital. Interviews were digitally recorded, and qualitative thematic analysis was employed to synthesize findings. RESULTS: Eighteen in-depth interviews were conducted. Age ranged from 62 to 78 years. Patients received intermediate- (50%) or high-intensity (44%) chemotherapy or best supportive care only (6%). Six themes of patient experiences emerged from the analysis: patients (1) felt overwhelmed and in shock at diagnosis, (2) felt powerless to make decisions, (3) felt rushed and unprepared to make a treatment decision, (4) desired to follow oncologist recommendations for treatment, (5) balanced multiple competing factors during treatment decision-making, and (6) desired for ongoing engagement into their care planning. Patients reported many treatment outcomes that were important in treatment decision-making. CONCLUSIONS: Older adults with newly diagnosed AML feel devastated and in shock at their diagnosis which appears to contribute to a feeling of being overwhelmed, unprepared, and rushed into treatment decisions. Because no one factor dominated treatment decision-making for all patients, the use of strategies to elicit individual patient preferences is critical to inform treatment decisions. Interventions are needed to reduce distress and increase a sense of participation in treatment decision-making.


Assuntos
Leucemia Mieloide Aguda , Oncologistas , Humanos , Idoso , Pessoa de Meia-Idade , Leucemia Mieloide Aguda/terapia , Tomada de Decisão Compartilhada , Emoções , Preferência do Paciente
4.
BMC Gastroenterol ; 24(1): 90, 2024 Feb 28.
Artigo em Inglês | MEDLINE | ID: mdl-38418997

RESUMO

BACKGROUND: Treatment choices in hepatocellular carcinoma (HCC) involve consideration of tradeoffs between the benefits, toxicities, inconvenience, and costs. Stated preference elicitation methods have been used in the medical field to help evaluate complex treatment decision-making. The aim of this study was to conduct a scoping review to assess the evidence base for the use of preference elicitation tools or willingness to pay/willingness to accept methods for HCC treatment decision-making from both the patient and provider perspective. METHODS: We performed a scoping review to identify abstracts or manuscripts focused on the role preference elicitation tools or willingness to pay/willingness to accept methods for HCC treatment options among patients, caregivers, and/or providers. Two researchers independently screened full-text references and resolved conflicts through discussion. We summarized key findings, including the type and setting of preference-elicitation tools used for HCC treatment decisions. RESULTS: Ten published abstracts or manuscripts evaluated the role of preference elicitation tools for HCC treatments. The studies revealed several attributes that are considered by patients and providers making HCC treatment decisions. Many of the studies reviewed suggested that while patients place the most value on extending their overall survival, they are willing to forgo overall survival to avoid risks of treatments and maintain quality of life. Studies of physicians and surgeons found that provider preferences are dependent on patient characteristics, provider specialty, and surgeon or hospital-related factors. CONCLUSION: This scoping review explored both patient and physician preferences towards treatment modalities in all stages of HCC. The studies revealed a large scope of potential attributes that may be important to patients and that many patients are willing to forgo survival to maintain quality of life. Further research should explore both preference elicitation of currently available and emerging therapies for HCC as well as the use of this data to develop patient-facing tools to assist in navigating treatment options.

5.
World Neurosurg ; 181: e1019-e1037, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37967744

RESUMO

BACKGROUND: Transsulcal tubular retractor-assisted minimally invasive parafascicular surgery changes the surgical strategy for deep-seated lesions by promoting a deficit-sparing approach. When integrated with preoperative brain mapping and intraoperative neuromonitoring (IONM), this approach may potentially improve patient outcomes. In this study, we assessed the impact of preoperative brain mapping and IONM in tubular retractor-assisted neuro-oncological surgery. METHODS: This retrospective single-center cohort study included patients who underwent transsulcal tubular retractor-assisted minimally invasive parafascicular surgery for resection of deep-seated brain tumors from 2016 to 2022. The cohort was divided into 3 groups: group 1, no preoperative mapping or IONM (17 patients); group 2, IONM only (25 patients); group 3, both preoperative mapping and IONM (38 patients). RESULTS: We analyzed 80 patients (33 males and 47 females) with a median age of 46.5 years (range: 1-81 years). There was no significant difference in mean tumor volume (26.2 cm3 [range 1.07-97.4 cm3]; P = 0.740) and mean preoperative depth of the tumor (31 mm [range 3-65 mm], P = 0.449) between the groups. A higher proportion of high-grade gliomas and metastases was present within group 3 (P = 0.003). IONM was related to fewer motor (P = 0.041) and language (P = 0.032) deficits at hospital discharge. Preoperative mapping and IONM were also related to shorter length of stay (P = 0.008). CONCLUSIONS: Preoperative and intraoperative brain mapping and monitoring enhance transsulcal tubular retractor-assisted minimally invasive parafascicular surgery in neuro-oncology. Patients had a reduced length of stay and prolonged overall survival. IONM alone reduces postoperative neurological deficit.


Assuntos
Neoplasias Encefálicas , Glioma , Monitorização Neurofisiológica Intraoperatória , Masculino , Feminino , Humanos , Lactente , Pré-Escolar , Criança , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Estudos Retrospectivos , Estudos de Coortes , Procedimentos Neurocirúrgicos , Neoplasias Encefálicas/diagnóstico por imagem , Neoplasias Encefálicas/cirurgia , Glioma/diagnóstico por imagem , Glioma/cirurgia
6.
Leuk Lymphoma ; 65(2): 209-218, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37921062

RESUMO

A large-scale genomic analysis of patients with ASXL1-mutated myeloid disease has not been performed to date. We reviewed comprehensive genomic profiling results from 6043 adults to characterize clinicopathologic features and co-mutation patterns by ASXL1 mutation status. ASXL1 mutations occurred in 1414 patients (23%). Mutation co-occurrence testing revealed strong co-occurrence (p < 0.01) between mutations in ASXL1 and nine genes (SRSF2, U2AF1, RUNX1, SETBP1, EZH2, STAG2, CUX1, CSF3R, CBL). Further analysis of patients with these co-mutations yielded several novel findings. Co-mutation patterns supported that ASXL1/SF3B1 co-mutation may be biologically distinct from ASXL1/non-SF3B1 spliceosome co-mutation. In AML, ASXL1/SRSF2 co-mutated patients frequently harbored STAG2 mutations (42%), which were dependent on the presence of both ASXL1 and SRSF2 mutation (p < 0.05). STAG2 and SETBP1 mutations were also exclusive in ASXL1/SRSF2 co-mutated patients and associated with divergent chronic myeloid phenotypes. Our findings support that certain multi-mutant genotypes may be biologically relevant in ASXL1-mutated myeloid disease.


Assuntos
Leucemia Mieloide Aguda , Transtornos Mieloproliferativos , Neoplasias , Adulto , Humanos , Transtornos Mieloproliferativos/genética , Spliceossomos/genética , Spliceossomos/patologia , Fatores de Transcrição/genética , Genômica , Mutação , Leucemia Mieloide Aguda/genética , Prognóstico , Proteínas Repressoras/genética
8.
J Neurosurg Spine ; 39(4): 583-592, 2023 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-37486861

RESUMO

OBJECTIVE: Lumbar spine decompression surgery, in the form of laminectomy or discectomy, is known to be effective in improving symptoms of radiculopathy and neurogenic claudication. However, it is less clear how it impacts coexisting low-back pain (LBP). The aim of this study was to quantify the change in LBP after lumbar decompression. METHODS: This study analyzed data from the British Spine Registry on patients who underwent lumbar decompression surgery. LBP severity was assessed using the visual analog scale (VAS), and the primary outcome was the change in VAS score at 1 year, with secondary outcomes measuring the change in score at 6 weeks, 6 months, and 2 years. The minimal clinically important difference (MCID) was defined as a 30% reduction in pain. RESULTS: Of the 25,349 patients included in the study, 92.2% reported significant back pain at baseline. Of the entire cohort, 12,951 (55.4%) patients had follow-up data for 6 weeks, 9066 (38.8%) for 6 months, 7926 (33.9%) for 1 year, and 5517 (23.6%) for 2 years; 17,304 (68.3%) patients had follow-up data for at least one time point. Sixty-two percent of patients attained the MCID (VAS score ≥ 30%) in back pain reduction, with 51% reporting a substantial improvement (VAS score ≥ 50%). This improvement was observed by 6 weeks postoperation and was mostly maintained at 2 years. Patients with back pain predominance were more likely to attain the MCID compared with those with leg pain predominance (63.6% vs 60.1%; OR 1.16, 95% CI 1.02-1.34; p = 0.0291). Severity of baseline back pain did not reduce the proportion attaining the MCID. CONCLUSIONS: Regardless of pain presentation, LBP improves in approximately 62% of patients who undergo lumbar decompressive surgery, with 51% experiencing substantial improvement. Patients undergoing lumbar decompression can be advised on the chance of a meaningful improvement in back pain postsurgery.


Assuntos
Dor Lombar , Radiculopatia , Estenose Espinal , Humanos , Vértebras Lombares/cirurgia , Dor Lombar/cirurgia , Dor nas Costas/cirurgia , Radiculopatia/cirurgia , Sistema de Registros , Resultado do Tratamento , Estenose Espinal/complicações , Estenose Espinal/cirurgia , Descompressão Cirúrgica
10.
J Geriatr Oncol ; 14(5): 101529, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-37244139

RESUMO

INTRODUCTION: Acute myeloid leukemia (AML) is associated with poor outcomes and is generally incurable. Therefore, understanding preferences of older adults with AML is critical. We sought to assess whether best-worst scaling (BWS) can be used to capture attributes considered by older adults with AML when making initial treatment decisions and longitudinally, as well as assess changes in health-related quality of life (HRQoL) and decisional regret over time. MATERIALS AND METHODS: In a longitudinal study for adults ≥60 years with newly diagnosed AML, we collected: (1) attributes of treatment most important to patients using BWS, (2) HRQoL using EQ-5D-5L, (3) decisional regret using the Decisional Regret Scale, and (4) treatment worthiness using the "Was it worth it?" questionnaire. Data was collected at baseline and over six months. A hierarchical Bayes model was used to allocate percentages out of 100%. Due to small sample size, hypothesis testing was performed at α = 0.10 (2-tailed). We analyzed how these measures differed by treatment choice (intensive vs. lower intensity treatment). RESULTS: Mean age of patients was 76 years (n = 15). At baseline, the most important attributes of treatment to patients were response to treatment (i.e., chance that the cancer will respond to treatment; 20.9%). Compared to those who received lower intensity treatment (n = 7) or best supportive care (n = 2), those who received intensive treatment (n = 6) generally ranked "alive one year or more after treatment" (p = 0.03) with higher importance and ranked "daily activities" (p = 0.01) and "location of treatment" (p = 0.01) with less importance. Overall, HRQoL scores were high. Decisional regret was mild overall and lower for patients who chose intensive treatment (p = 0.06). DISCUSSION: We demonstrated that BWS can be used to assess the importance of various treatment attributes considered by older adults with AML when making initial treatment decisions and longitudinally throughout treatment. Attributes of treatment important to older patients with AML differed between treatment groups and changed over time. Interventions are needed to re-assess patient priorities throughout treatment to ensure care aligns with patient preferences.


Assuntos
Tomada de Decisões , Leucemia Mieloide Aguda , Humanos , Idoso , Estudos Longitudinais , Preferência do Paciente , Qualidade de Vida , Teorema de Bayes , Emoções , Leucemia Mieloide Aguda/terapia
11.
Int J STD AIDS ; 34(9): 588-602, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37247427

RESUMO

This is the first British Association of Sexual Health and HIV (BASHH) national guideline for the management of sexually transmitted enteric infections (STEI). This guideline is primarily aimed for level 3 sexual health clinics; however, it may also be applicable to other settings such as primary care or other hospital departments where individuals with STEI may present. This guideline makes recommendations on testing, management, partner notification and public health control of STEI.


Assuntos
Infecções por HIV , Saúde Sexual , Infecções Sexualmente Transmissíveis , Humanos , HIV , Infecções Sexualmente Transmissíveis/diagnóstico , Infecções Sexualmente Transmissíveis/tratamento farmacológico , Infecções Sexualmente Transmissíveis/epidemiologia , Infecções por HIV/diagnóstico , Infecções por HIV/tratamento farmacológico , Infecções por HIV/epidemiologia , Instituições de Assistência Ambulatorial , Reino Unido
12.
Support Care Cancer ; 31(1): 95, 2023 Jan 04.
Artigo em Inglês | MEDLINE | ID: mdl-36598590

RESUMO

BACKGROUND: Older adults with AML commonly receive a hypomethylating agent (HMA) as first-line therapy. The addition of venetoclax (VEN) to HMAs has been shown to improve remission rates and overall survival. The use of combination therapy (HMA + VEN) requires frequent follow-up, results in longer infusion times, and likely increases caregiver responsibility at home. We describe experiences of informal caregivers (family/friends) providing care to older adults with AML receiving HMA + VEN. METHODS: Fourteen caregivers of older adults with AML receiving HMA + VEN (September 2020 to September 2021) were recruited as part of a control group of an ongoing NIH-funded clinical trial. Semi-structured interviews were conducted to gain initial insight into caregiver experiences at the start of HMA + VEN treatment. Two researchers analyzed the data using thematic content analysis. Data saturation occurred when no new themes were found in subsequent interviews, but all interviews were coded and synthesized. RESULTS: Of the 14 caregivers interviewed, the majority were spouses (n = 10), female (n = 13), and aged 45 to 83 (median age 65). We identified five themes: (1) the impact of an AML diagnosis in older adulthood, (2) care recipient condition changes, (3) perspectives of caregiving roles and tasks, (4) factors influencing caregiving experiences, and (5) support system roles. CONCLUSIONS AND IMPLICATIONS: Caregivers for older adults with AML report a range of experiences navigating health systems, caregiving responsibilities, and resource needs. The risk for caregiver burden and unmet needs should be addressed to improve caregivers' abilities to provide care.


Assuntos
Cuidadores , Leucemia Mieloide Aguda , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Compostos Bicíclicos Heterocíclicos com Pontes/uso terapêutico , Sulfonamidas/uso terapêutico , Ensaios Clínicos como Assunto
13.
Haematologica ; 108(4): 1006-1014, 2023 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-35861016

RESUMO

Time at home is a critically important outcome to adults with acute myeloid leukemia (AML) when selecting treatment; however, no study to date has adequately described the amount of time older adults spend at home following initiation of chemotherapy. We queried records from a multi-institution health system to identify adults aged ≥60 years newly diagnosed with AML who were treated with azacitidine or venetoclax and evaluated the proportion of days at home (PDH) following diagnosis. Days were considered "at home" if patients were not admitted or seen in the emergency department or oncology/infusion clinic. Assessed covariates included demographics and disease risk. Associations between PDH and baseline characteristics were evaluated via linear regression, adjusted for log length of follow-up. From 2015-2020, 113 older adults were identified. Most received azacitidine plus venetoclax (51.3%) followed by azacitidine monotherapy (38.9%). The mean PDH for all patients was 0.58 (95% confidence interval: 0.54-0.63, median 0.63). PDH increased among survivors over time. PDH did not differ between therapy groups (adjusted mean, azacitidine plus venetoclax: 0.68; azacitidine monotherapy: 0.66; P=0.64) or between disease risk categories (P=0.34). Compared to patients receiving azacitidine monotherapy, patients receiving azacitidine plus venetoclax had longer clinic visits (median minutes: 127.9 vs. 112.9, P<0.001) and infusion visits (median minutes: 194.3 vs. 132.5, P<0.001). The burden of care for older adults with AML treated with "less intense" chemotherapy is high. The addition of venetoclax to azacitidine did not translate into increased time at home. Future prospective studies should evaluate patient-centered outcomes, including time at home, to inform shared decision-making and drug development.


Assuntos
Azacitidina , Leucemia Mieloide Aguda , Humanos , Idoso , Estudos Prospectivos , Compostos Bicíclicos Heterocíclicos com Pontes , Leucemia Mieloide Aguda/diagnóstico , Leucemia Mieloide Aguda/tratamento farmacológico , Leucemia Mieloide Aguda/etiologia , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos
14.
Cancer Med ; 12(7): 8581-8593, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36533397

RESUMO

BACKGROUND: In a single-arm pilot study, we assessed the feasibility and usefulness of an innovative patient-centered communication tool (UR-GOAL tool) that addresses aging-related vulnerabilities, patient values, and prognostic awareness for use in treatment decision making between older adults with newly diagnosed acute myeloid leukemia (AML), their caregivers, and oncologists. METHODS: Primary feasibility metric was retention rate; >50% was considered feasible. We collected recruitment rate, usefulness, and outcomes including AML knowledge (range 0-14) and perceived efficacy in communicating with oncologists (range 5-25). Due to the pilot nature and small sample size, hypothesis testing was performed at α = 0.10. RESULTS: We included 15 patients (mean age 76 years, range 64-88), 12 caregivers, and 5 oncologists; enrollment and retention rates for patients were 84% and 73%, respectively. Patients agreed that the UR-GOAL tool helped them understand their AML diagnosis and treatment options, communicate with their oncologist, and make more informed decisions. From baseline to post-intervention, patients and caregivers scored numerically higher on AML knowledge (patients: +0.6, p = 0.22; caregivers: +1.1, p = 0.05) and perceived greater efficacy in communicating with their oncologists (patients: +1.5, p = 0.22; caregivers: +1.2, p = 0.06). CONCLUSION: We demonstrated that it is feasible to incorporate the UR-GOAL tool into treatment decision making for older patients with AML, their caregivers, and oncologists.


Assuntos
Leucemia Mieloide Aguda , Oncologistas , Humanos , Idoso , Pessoa de Meia-Idade , Idoso de 80 Anos ou mais , Projetos Piloto , Cuidadores , Leucemia Mieloide Aguda/diagnóstico , Leucemia Mieloide Aguda/terapia , Comunicação , Assistência Centrada no Paciente
15.
Oncologist ; 28(2): 105-115, 2023 02 08.
Artigo em Inglês | MEDLINE | ID: mdl-36342114

RESUMO

BACKGROUND: Patient decision aids (PDAs) are tools designed to facilitate decision-making. In this systematic review, we summarized existing studies on the development and evaluation of PDAs for patients with hematologic malignancies. PATIENTS AND METHODS: We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched for articles in PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov. We included studies, abstracts, and clinical trial protocols available in English involving PDAs for patients age ≥18 diagnosed with a hematologic malignancy and/or their caregivers. Data were summarized using descriptive statistics. RESULTS: Of the 5281 titles/abstracts screened, 15 were included: 1 protocol, 7 abstracts, and 7 full-texts. Six were PDA developmental studies, 6 were pilot studies, and 3 were randomized trials. PDA formats included electronic with web content, videos, and/or audio, questionnaires, bedside instruments, and a combination of various formats. Average participant age ranged from 36.0 to 62.4 years. Patients and caregivers identified efficacy, adverse effects, cost, and quality of life as important decision-making factors. PDAs were associated with increased knowledge and patient satisfaction as well as decreased decisional conflict and attitudinal barriers. Research on PDAs for adult patients with hematologic malignancies and their caregivers is limited. Among the studies, PDAs appear to support patients in shared decision-making. CONCLUSION: While current literature examining the use of PDAs for adults with hematologic malignancies is limited, the positive impact of PDAs on shared decision-making and patient outcomes warrants additional research in this field.


Assuntos
Técnicas de Apoio para a Decisão , Qualidade de Vida , Adulto , Humanos , Pessoa de Meia-Idade , Satisfação do Paciente , Tomada de Decisão Compartilhada , Projetos Piloto
16.
JAMA Oncol ; 8(11): 1616-1623, 2022 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-36136321

RESUMO

Importance: Monitoring of the corrected QT interval (QTc) for patients with cancer receiving chemotherapy is not standardized. Selection of QTc formula may be associated with adverse event grading and chemotherapy delivery. Objective: To describe the association of QTc formula selection with adverse event grading and chemotherapy delivery. Design, Setting, and Participants: This retrospective observational cohort study used data from January 2010 to April 2020 and included adult patients seen at the University of North Carolina Cancer Hospital who had an electrocardiogram (ECG) performed. Exposures: Adjusted QTc using the Bazett, Fridericia, and Framingham formulae. Main Outcomes and Measures: The main outcome was QTc prolongation using the Common Terminology Criteria for Adverse Events (CTCAE). Consistency between formulae was evaluated. Subsequently, appropriateness of clinical management due to prolonged QTc was assessed for a subset of patients being treated with chemotherapy agents associated with a prolonged QT interval. We hypothesized that use of the Bazett formula would be associated with higher rates of QTc prolongation and inappropriate modifications to chemotherapy. Results: A total of 19 955 ECGs from 6881 adult patients (3055 [44.4%] women, 3826 [55.6%] men; median [IQR] age at first ECG, 60 [47-68] years) were analyzed. The percentage of ECGs with grade 3 QTc prolongation differed by formula (all patients: Framingham, 1.8%; Fridericia, 2.8%; and Bazett, 9.0%; patients receiving QT-prolonging chemotherapy [2340 ECGs]: Framingham, 2.7%; Fridericia, 4.5%; and Bazett, 12.5%). The Bazett formula resulted in a median QTc value 26.4 milliseconds higher than Fridericia and 27.8 milliseconds higher than Framingham. Of the 1786 ECGs classified as grade 3 by Bazett, 1446 (81.0%) were grade 2 or less by either Fridericia or Framingham. A total of 5 of 28 (17.9%) evaluated clinical changes associated with prolonged QTc were deemed inappropriate when using either Fridericia or Framingham formula. Conclusions and Relevance: Findings of this cohort study suggest that the Bazett formula resulted in higher QTc values associated with a 3-fold increase in grade 3 CTCAE toxic effects compared with other common formulae. Use of the Bazett formula likely was associated with inappropriate changes in clinical management. These data support the use of a standard QTc formula (such as Fridericia or Framingham) for QTc correction in oncology.


Assuntos
Síndrome do QT Longo , Neoplasias , Adulto , Masculino , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Frequência Cardíaca , Estudos de Coortes , Estudos Retrospectivos , Síndrome do QT Longo/induzido quimicamente , Síndrome do QT Longo/diagnóstico , Neoplasias/tratamento farmacológico
18.
JMIR Res Protoc ; 11(6): e39586, 2022 Jun 29.
Artigo em Inglês | MEDLINE | ID: mdl-35767340

RESUMO

BACKGROUND: The approval of novel therapies for patients diagnosed with hematologic malignancies have improved survival outcomes but increased the challenge of aligning chemotherapy choices with patient preferences. We previously developed paper versions of a discrete choice experiment (DCE) and a best-worst scaling (BWS) instrument to quantify the treatment outcome preferences of patients with hematologic malignancies to inform shared decision making. OBJECTIVE: We aim to develop an electronic health care tool (EHT) to guide clinical decision making that uses either a BWS or DCE instrument to capture patient preferences. The primary objective of this study is to use both qualitative and quantitative methods to evaluate the perceived usability, cognitive workload (CWL), and performance of electronic prototypes that include the DCE and BWS instrument. METHODS: This mixed methods study includes iterative co-design methods that will involve healthy volunteers, patient-caregiver pairs, and health care workers to evaluate the perceived usability, CWL, and performance of tasks within distinct prototypes. Think-aloud sessions and semistructured interviews will be conducted to collect qualitative data to develop an affinity diagram for thematic analysis. Validated assessments (Post-Study System Usability Questionnaire [PSSUQ] and the National Aeronautical and Space Administration's Task Load Index [NASA-TLX]) will be used to evaluate the usability and CWL required to complete tasks within the prototypes. Performance assessments of the DCE and BWS will include the evaluation of tasks using the Single Easy Questionnaire (SEQ), time to complete using the prototype, and the number of errors. Additional qualitative assessments will be conducted to gather participants' feedback on visualizations used in the Personalized Treatment Preferences Dashboard that provides a representation of user results after completing the choice tasks within the prototype. RESULTS: Ethical approval was obtained in June 2021 from the Institutional Review Board of the University of North Carolina at Chapel Hill. The DCE and BWS instruments were developed and incorporated into the PRIME (Preference Reporting to Improve Management and Experience) prototype in early 2021 and prototypes were completed by June 2021. Heuristic evaluations were conducted in phase 1 and completed by July 2021. Recruitment of healthy volunteers began in August 2021 and concluded in September 2021. In December 2021, our findings from phase 2 were accepted for publication. Phase 3 recruitment began in January 2022 and is expected to conclude in September 2022. The data analysis from phase 3 is expected to be completed by November 2022. CONCLUSIONS: Our findings will help differentiate the usability, CWL, and performance of the DCE and BWS within the prototypes. These findings will contribute to the optimization of the prototypes, leading to the development of an EHT that helps facilitate shared decision making. This evaluation will inform the development of EHTs to be used clinically with patients and health care workers. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39586.

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