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1.
Schmerz ; 2024 Feb 21.
Artigo em Alemão | MEDLINE | ID: mdl-38381187

RESUMO

INTRODUCTION: Chronic low back pain (cLBP) is highly prevalent in the United States and globally, resulting in functional impairment and lowered quality of life. While many treatments are available for cLBP, clinicians have little information about which specific treatment(s) will work best for individual patients or subgroups of patients. The Back Pain Research Consortium, part of the National Institutes of Health Helping to End Addiction Long-termSM (HEAL) Initiative, will conduct a collaborative clinical trial, which seeks to develop a personalized medicine algorithm to optimize patient and provider treatment selection for patients with cLBP. OBJECTIVE: The primary objective of this article is to provide an update on evidence-based cLBP interventions and describe the process of reviewing and selecting interventions for inclusion in the clinical trial. METHODS: A working group of cLBP experts reviewed and selected interventions for inclusion in the clinical trial. The primary evaluation measures were strength of evidence and magnitude of treatment effect. When available in the literature, duration of effect, onset time, carryover effect, multimodal efficacy, responder subgroups, and evidence for the mechanism of treatment effect or biomarkers were considered. CONCLUSION: The working group selected 4 leading, evidence-based treatments for cLBP to be tested in the clinical trial and for use in routine clinical treatment. These treatments include (1) duloxetine, (2) acceptance and commitment therapy, (3) a classification-based exercise and manual therapy intervention, and (4) a self-management approach. These interventions each had a moderate to high level of evidence to support a therapeutic effect and were from different therapeutic classes.

4.
Pain Rep ; 7(5): e1019, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36203645

RESUMO

Introduction: Chronic low back pain (cLBP) is highly prevalent in the United States and globally, resulting in functional impairment and lowered quality of life. While many treatments are available for cLBP, clinicians have little information about which specific treatment(s) will work best for individual patients or subgroups of patients. The Back Pain Research Consortium, part of the National Institutes of Health Helping to End Addiction Long-termSM (HEAL) Initiative, will conduct a collaborative clinical trial, which seeks to develop a personalized medicine algorithm to optimize patient and provider treatment selection for patients with cLBP. Objective: The primary objective of this article is to provide an update on evidence-based cLBP interventions and describe the process of reviewing and selecting interventions for inclusion in the clinical trial. Methods: A working group of cLBP experts reviewed and selected interventions for inclusion in the clinical trial. The primary evaluation measures were strength of evidence and magnitude of treatment effect. When available in the literature, duration of effect, onset time, carryover effect, multimodal efficacy, responder subgroups, and evidence for the mechanism of treatment effect or biomarkers were considered. Conclusion: The working group selected 4 leading, evidence-based treatments for cLBP to be tested in the clinical trial and for use in routine clinical treatment. These treatments include (1) duloxetine, (2) acceptance and commitment therapy, (3) a classification-based exercise and manual therapy intervention, and (4) a self-management approach. These interventions each had a moderate to high level of evidence to support a therapeutic effect and were from different therapeutic classes.

6.
J Med Internet Res ; 24(5): e37480, 2022 05 25.
Artigo em Inglês | MEDLINE | ID: mdl-35612905

RESUMO

BACKGROUND: We previously reported the efficacy of an 8-week home-based therapeutic immersive virtual reality (VR) program in a double-blind randomized placebo-controlled study. Community-based adults with self-reported chronic low back pain were randomized 1:1 to receive either (1) a 56-day immersive therapeutic pain relief skills VR program (EaseVRx) or (2) a 56-day sham VR program. Immediate posttreatment results revealed the superiority of therapeutic VR over sham VR for reducing pain intensity; pain-related interference with activity, mood, and stress (but not sleep); physical function; and sleep disturbance. At 3 months posttreatment, therapeutic VR maintained superiority for reducing pain intensity and pain-related interference with activity, stress, and sleep (new finding). OBJECTIVE: This study assessed between-group and within-group treatment effects 6 months posttreatment to determine the extended efficacy, magnitude of efficacy, and clinical importance of home-based therapeutic VR. METHODS: E-surveys were deployed at pretreatment, end-of-treatment, and posttreatment months 1, 2, 3, and 6. Self-reported data for 188 participants were analyzed in a mixed-model framework using a marginal model to allow for correlated responses across the repeated measures. Primary outcomes were pain intensity and pain-related interference with activity, mood, stress, and sleep at 6 months posttreatment. Secondary outcomes were Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance and physical function. RESULTS: Therapeutic VR maintained significant and clinically meaningful effects 6 months posttreatment and remained superior to sham VR for reducing pain intensity and pain-related interference with activity, stress, and sleep (ds=0.44-0.54; P<.003). Between-group comparisons for physical function and sleep disturbance showed superiority of EaseVRx over sham VR (ds=0.34; P=.02 and ds=0.46; P<.001, respectively). Participants were encouraged to contact study staff with any problems experienced during treatment; however, no participants contacted study staff to report adverse events of any type, including nausea and motion sickness. CONCLUSIONS: Our 8-week home-based VR pain management program caused important reductions in pain intensity and interference up to 6 months after treatment. Additional studies are needed in diverse samples. TRIAL REGISTRATION: ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/25291.


Assuntos
Dor Lombar , Transtornos do Sono-Vigília , Realidade Virtual , Adulto , Seguimentos , Humanos , Dor Lombar/terapia , Manejo da Dor/métodos , Medição da Dor , Transtornos do Sono-Vigília/terapia
7.
J Pain ; 23(5): 822-840, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-34902548

RESUMO

Prior work established post-treatment efficacy for an 8-week home-based therapeutic virtual reality (VR) program in a double-blind, parallel arm, randomized placebo-controlled study. Participants were randomized 1:1 to 1 of 2 56-day VR programs: 1) a therapeutic immersive pain relief skills VR program; or 2) a Sham VR program within an identical commercial VR headset. Immediate post-treatment results demonstrated clinically meaningful and superior reduction for therapeutic VR compared to Sham VR for average pain intensity, indices of pain-related interference (activity, mood, stress but not sleep), physical function, and sleep disturbance. The objective of the current report was to quantify treatment effects to post-treatment month 3 and describe durability of effects. Intention-to-treat analyses revealed sustained benefits for both groups and superiority for therapeutic VR for pain intensity and multiple indices of pain-related interference (activity, stress, and newly for sleep; effect sizes ranged from drm = .56-.88) and physical function from pre-treatment to post-treatment month 3. The between-group difference for sleep disturbance was non-significant and pain-interference with mood did not survive multiplicity correction at 3 months. For most primary and secondary outcomes, treatment effects for therapeutic VR showed durability, and maintained superiority to Sham VR in the 3-month post-treatment period. PERSPECTIVE: We present 3-month follow-up results for 8-week self-administered therapeutic virtual reality (VR) compared to Sham VR in adults with chronic low back pain. Across multiple pain indices, therapeutic VR had clinically meaningful benefits, and superiority over Sham VR. Home-based, behavioral skills VR yielded enduring analgesic benefits; longer follow-up is needed.


Assuntos
Dor Lombar , Realidade Virtual , Adulto , Seguimentos , Humanos , Dor Lombar/terapia , Manejo da Dor/métodos , Medição da Dor
8.
BMJ Open ; 11(6): e050545, 2021 06 15.
Artigo em Inglês | MEDLINE | ID: mdl-34130965

RESUMO

INTRODUCTION: Chronic pain is highly prevalent and associated with a large burden of illness; there is a pressing need for safe, home-based, non-pharmacological, interventions. Virtual reality (VR) is a digital therapeutic known to be effective for acute pain, but its role in chronic pain is not yet fully elucidated. Here we present a protocol for the National Institute of Health (NIH) Back Pain Consortium (BACPAC) VR trial that evaluates the effectiveness of three forms of VR for patients with chronic lower back pain (cLBP), a highly prevalent form of chronic pain. METHODS AND ANALYSIS: The NIH BACPAC VR trial will randomise 360 patients with cLBP into one of three arms, each administered through a head-mounted display: 1) skills-based VR, a program incorporating principles of cognitive behavioural therapy, mindful meditation and physiological biofeedback therapy using embedded biometric sensors; 2) distraction-based VR, a program using 360-degree immersive videos designed to distract users from pain; and 3) sham VR, a non-immersive program using two-dimensional videos within a VR headset. Research participants will be monitored for 12 weeks using a combination of patient-reported outcomes administered via REDCap (Research Electronic Data Capture), wearable sensor data collected via Fitbit Charge 4 and electronic health record data. The primary outcome will be the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale. Secondary outcomes will include PROMIS Anxiety, PROMIS Sleep Disturbance, opioid prescription data and Pain Catastrophizing Scale Short Form. A subgroup analysis will explore patient level predictors for VR efficacy. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Institutional Review Board of Cedars-Sinai Health System in April 2020. The results will be disseminated in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04409353.


Assuntos
Dor Aguda , Dor Crônica , Dor Lombar , Terapia de Exposição à Realidade Virtual , Realidade Virtual , Dor Crônica/terapia , Humanos , Dor Lombar/terapia , Medição da Dor , Ensaios Clínicos Controlados Aleatórios como Assunto
10.
J Med Internet Res ; 23(2): e26292, 2021 02 22.
Artigo em Inglês | MEDLINE | ID: mdl-33484240

RESUMO

BACKGROUND: Chronic low back pain is the most prevalent chronic pain condition worldwide and access to behavioral pain treatment is limited. Virtual reality (VR) is an immersive technology that may provide effective behavioral therapeutics for chronic pain. OBJECTIVE: We aimed to conduct a double-blind, parallel-arm, single-cohort, remote, randomized placebo-controlled trial for a self-administered behavioral skills-based VR program in community-based individuals with self-reported chronic low back pain during the COVID-19 pandemic. METHODS: A national online convenience sample of individuals with self-reported nonmalignant low back pain with duration of 6 months or more and with average pain intensity of 4 or more/10 was enrolled and randomized 1:1 to 1 of 2 daily (56-day) VR programs: (1) EaseVRx (immersive pain relief skills VR program); or (2) Sham VR (2D nature content delivered in a VR headset). Objective device use data and self-reported data were collected. The primary outcomes were the between-group effect of EaseVRx versus Sham VR across time points, and the between-within interaction effect representing the change in average pain intensity and pain-related interference with activity, stress, mood, and sleep over time (baseline to end-of-treatment at day 56). Secondary outcomes were global impression of change and change in physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, pain medication use, and user satisfaction. Analytic methods included intention-to-treat and a mixed-model framework. RESULTS: The study sample was 179 adults (female: 76.5%, 137/179; Caucasian: 90.5%, 162/179; at least some college education: 91.1%, 163/179; mean age: 51.5 years [SD 13.1]; average pain intensity: 5/10 [SD 1.2]; back pain duration ≥5 years: 67%, 120/179). No group differences were found for any baseline variable or treatment engagement. User satisfaction ratings were higher for EaseVRx versus Sham VR (P<.001). For the between-groups factor, EaseVRx was superior to Sham VR for all primary outcomes (highest P value=.009), and between-groups Cohen d effect sizes ranged from 0.40 to 0.49, indicating superiority was moderately clinically meaningful. For EaseVRx, large pre-post effect sizes ranged from 1.17 to 1.3 and met moderate to substantial clinical importance for reduced pain intensity and pain-related interference with activity, mood, and stress. Between-group comparisons for Physical Function and Sleep Disturbance showed superiority for the EaseVRx group versus the Sham VR group (P=.022 and .013, respectively). Pain catastrophizing, pain self-efficacy, pain acceptance, prescription opioid use (morphine milligram equivalent) did not reach statistical significance for either group. Use of over-the-counter analgesic use was reduced for EaseVRx (P<.01) but not for Sham VR. CONCLUSIONS: EaseVRx had high user satisfaction and superior and clinically meaningful symptom reduction for average pain intensity and pain-related interference with activity, mood, and stress compared to sham VR. Additional research is needed to determine durability of treatment effects and to characterize mechanisms of treatment effects. Home-based VR may expand access to effective and on-demand nonpharmacologic treatment for chronic low back pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/25291.


Assuntos
COVID-19 , Dor Crônica/terapia , Comportamentos Relacionados com a Saúde , Dor Lombar/terapia , Manejo da Dor/métodos , Realidade Virtual , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , COVID-19/epidemiologia , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , Autorrelato , Fatores de Tempo , Adulto Jovem
11.
JMIR Res Protoc ; 10(1): e25291, 2021 01 19.
Artigo em Inglês | MEDLINE | ID: mdl-33464215

RESUMO

BACKGROUND: Chronic pain is one of the most common and debilitating health conditions. Treatments for chronic low back pain typically focus on biomedical treatment approaches. While psychosocial treatments exist, multiple barriers prevent broad access. There is a significant unmet need for integrative, easily accessible, non-opioid solutions for chronic pain. Virtual reality (VR) is an immersive technology allowing innovation in the delivery of behavioral pain treatments. Behavioral skills-based VR is effective at facilitating pain management and reducing pain-related concerns. Continued research on these emerging approaches is needed. OBJECTIVE: In this randomized controlled trial, we seek to test the efficacy of a self-administered behavioral skills-based VR program as a nonpharmacological home-based pain management treatment for people with chronic low back pain (cLBP). METHODS: We will randomize 180 individuals with cLBP to 1 of 2 VR programs: (1) EaseVRx (8-week skills-based VR program); or (2) Sham VR (control condition). All participants will receive a VR headset to minimize any biases related to the technology's novelty. The Sham VR group had 2D neutral content in a 3D theater-like environment. Our primary outcome is average pain intensity and pain-related interference with activity, stress, mood, and sleep. Our secondary outcomes include patient-reported physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, health utilization, medication use, and user satisfaction. We hypothesize superiority for the skills-based VR program in all of these measures compared to the control condition. Team statisticians blinded to treatment assignment will assess outcomes up to 6 months posttreatment using an approach suitable for the longitudinal nature of the data. RESULTS: The study was approved by the Western Institutional Review Board on July 2, 2020. The protocol (NCT04415177) was registered on May 27, 2020. Recruitment for this study was completed in July 2020, and data collection will remain active until March 2021. In total, 186 participants were recruited. Multiple manuscripts will be generated from this study. The primary manuscript will be submitted for publication in the winter of 2020. CONCLUSIONS: Effectively delivering behavioral treatments in VR could overcome barriers to care and provide scalable solutions to chronic pain's societal burden. Our study could help shape future research and development of these innovative approaches. TRIAL REGISTRATION: ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/25291.

12.
Front Hum Neurosci ; 14: 96, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32300295

RESUMO

The use of head-mounted displays (HMD) for virtual reality (VR) application-based purposes including therapy, rehabilitation, and training is increasing. Despite advancements in VR technologies, many users still experience sickness symptoms. VR sickness may be influenced by technological differences within HMDs such as resolution and refresh rate, however, VR content also plays a significant role. The primary objective of this systematic review and meta-analysis was to examine the literature on HMDs that report Simulator Sickness Questionnaire (SSQ) scores to determine the impact of content. User factors associated with VR sickness were also examined. A systematic search was conducted according to PRISMA guidelines. Fifty-five articles met inclusion criteria, representing 3,016 participants (mean age range 19.5-80; 41% female). Findings show gaming content recorded the highest total SSQ mean 34.26 (95%CI 29.57-38.95). VR sickness profiles were also influenced by visual stimulation, locomotion and exposure times. Older samples (mean age ≥35 years) scored significantly lower total SSQ means than younger samples, however, these findings are based on a small evidence base as a limited number of studies included older users. No sex differences were found. Across all types of content, the pooled total SSQ mean was relatively high 28.00 (95%CI 24.66-31.35) compared with recommended SSQ cut-off scores. These findings are of relevance for informing future research and the application of VR in different contexts.

13.
Games Health J ; 9(2): 129-136, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31804853

RESUMO

Objectives: Recent studies have established the usage of virtual reality (VR) to help alleviate acute and chronic pain. VR technology can be cost prohibitive and cheaper alternatives are desired. In this study, a Google Cardboard headset ($15) combined with a smartphone was used as a low-cost VR device to assess efficacy in altering the perception of pain. Materials and Methods: The cold pressor test, a minimal-risk method, was used to simulate pain. Participants immersed their hands into ice water, with and without VR, in a crossover manner, and their pain perception data were recorded. Results: Forty-eight healthy volunteer participants completed the study between 2017 and 2018. Participants were randomized to right hand control, left control, right experimental, and left experimental groups, respectively, before the crossover. Data collected included pain threshold (time at which participants first reported pain), pain tolerance (time at which participants removed their hand), and pain intensity (highest reported pain level on a [1-10] scale). Approximately two-thirds of participants had improvements in pain threshold and pain tolerance with a mean improvement of +13.0 seconds (P = 0.0045) for pain threshold and +29.8 seconds (P = 0.0003) for pain tolerance. Pain intensity had a reduction of 0.43 points (P = 0.0371). Conclusion: Our results demonstrate that inexpensive VR devices, such as the Google Cardboard headset used in this study, may be a safe, portable, and cost-effective way to alter the perception and improve tolerance of pain.


Assuntos
Temperatura Baixa/efeitos adversos , Voluntários Saudáveis/psicologia , Manejo da Dor/normas , Realidade Virtual , Adulto , Análise de Variância , Estudos Cross-Over , Feminino , Voluntários Saudáveis/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Manejo da Dor/métodos , Manejo da Dor/psicologia , Projetos Piloto
14.
Brachytherapy ; 18(3): 306-312, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30853392

RESUMO

PURPOSE: Pulmonary seed emboli to the chest may occur after permanent prostate brachytherapy (PPB). The purpose of this study is to analyze factors associated with seed migration to the chest in a large series of PPB patients from a single institution undergoing implant with either loose seeds (LS), mixed loose and stranded seeds (MS), or exclusively stranded seeds in an absorbable vicryl suture (VS). METHODS AND MATERIALS: Between May 1998 and July 2015, a total of 1000 consecutive PPB patients with postoperative diagnostic chest x-rays at 4 months after implant were analyzed for seed migration. Patients were grouped based on seed implant technique: LS = 391 (39.1%), MS = 43 (4.3%), or VS = 566 (56.6%). Univariate and multivariate analysis were performed using Cox proportional hazards regression models to determine predictors of seed migration. RESULTS: Overall, 18.8% of patients experienced seed migration to the chest. The incidence of seed migration per patient was 45.5%, 11.6%, and 0.9% (p < 0.0001), for patients receiving LS, MS, or VS PPB, respectively. The right and left lower lobes were the most frequent sites of pulmonary seed migration. On multivariable analysis, planimetry volume (p = 0.0002; HR = 0.7 per 10 cc [0.6-0.8]), number of seeds implanted (p < 0.0001, HR = 2.4 per 25 seeds [1.7-3.4]), LS implant (p < 0.0001, HR = 15.9 [5.9-42.1]), and MS implant (p = 0.001, HR = 7.9 [2.3-28.1]) were associated with seed migration to the chest. CONCLUSIONS: In this large series, significantly higher rates of seed migration to the chest are observed in implants using any LS with observed hazard ratios of 15.9 and 7.9 for LS and MS respectively, as compared with implants using solely stranded seeds.


Assuntos
Braquiterapia/efeitos adversos , Braquiterapia/instrumentação , Migração de Corpo Estranho/diagnóstico por imagem , Migração de Corpo Estranho/etiologia , Pulmão/diagnóstico por imagem , Neoplasias da Próstata/radioterapia , Idoso , Humanos , Radioisótopos do Iodo , Masculino , Pessoa de Meia-Idade , Próteses e Implantes/efeitos adversos , Falha de Prótese/efeitos adversos , Radiografia
15.
JMIR Ment Health ; 6(1): e11973, 2019 Jan 31.
Artigo em Inglês | MEDLINE | ID: mdl-30702436

RESUMO

BACKGROUND: Therapeutic virtual reality (VR) has emerged as an efficacious treatment modality for a wide range of health conditions. However, despite encouraging outcomes from early stage research, a consensus for the best way to develop and evaluate VR treatments within a scientific framework is needed. OBJECTIVE: We aimed to develop a methodological framework with input from an international working group in order to guide the design, implementation, analysis, interpretation, and communication of trials that develop and test VR treatments. METHODS: A group of 21 international experts was recruited based on their contributions to the VR literature. The resulting Virtual Reality Clinical Outcomes Research Experts held iterative meetings to seek consensus on best practices for the development and testing of VR treatments. RESULTS: The interactions were transcribed, and key themes were identified to develop a scientific framework in order to support best practices in methodology of clinical VR trials. Using the Food and Drug Administration Phase I-III pharmacotherapy model as guidance, a framework emerged to support three phases of VR clinical study designs-VR1, VR2, and VR3. VR1 studies focus on content development by working with patients and providers through the principles of human-centered design. VR2 trials conduct early testing with a focus on feasibility, acceptability, tolerability, and initial clinical efficacy. VR3 trials are randomized, controlled studies that evaluate efficacy against a control condition. Best practice recommendations for each trial were provided. CONCLUSIONS: Patients, providers, payers, and regulators should consider this best practice framework when assessing the validity of VR treatments.

16.
J Neurooncol ; 130(3): 553-560, 2016 12.
Artigo em Inglês | MEDLINE | ID: mdl-27816997

RESUMO

Neurofibromatosis type 2 (NF2) is a debilitating genetic condition with potential development of multiple meningiomas. We report our experience treating a series of NF2-associated intracranial meningiomas with Gamma Knife radiosurgery (GKRS). Between 1992 and 2013, 15 consecutive patients (age 20-54 years) with 62 intracranial meningiomas were treated with single-fraction GKRS. Fifty-five percent of tumors involved the convexity or parasagittal/falx. The median prescription dose was 16 Gy (range 13-20 Gy). The median tumor diameter was 2.1 cm (range 0.7-4.5 cm). The median radiographic and clinical follow-up periods were 103 and 111 months, respectively. The 5-year and 10-year local controls were both 96 %. The disease specific survival was 93 % at 5 years and 68 % at 10 years. Fifty-three percent of patients had multiple meningiomas and received multiple GKRS treatments (range 1-7) for new or enlarging intracranial meningiomas. 11 (73 %) patients were alive at last follow-up, with 60 (97 %) tumors controlled (smaller or unchanged in size). There were 2 in-field failures, one at 1 year and the other at 3.5 years. There were no marginal failures. Major Complications after GKRS included: 1 case of radiation necrosis, 1 case of post treatment edema, and 1 case of a presumed radiation induced cavernous malformation 5 years after GKRS. GK is an effective treatment for enlarging NF2-associated meningiomas. No cases of malignant transformation or secondary malignancies were seen during the follow-up period.


Assuntos
Neoplasias Meníngeas/radioterapia , Meningioma/radioterapia , Neurofibromina 2/metabolismo , Radiocirurgia/métodos , Adolescente , Adulto , Criança , Estudos de Coortes , Relação Dose-Resposta à Radiação , Feminino , Humanos , Masculino , Neoplasias Meníngeas/metabolismo , Neoplasias Meníngeas/mortalidade , Meningioma/metabolismo , Meningioma/mortalidade , Pessoa de Meia-Idade , Análise de Sobrevida , Resultado do Tratamento , Adulto Jovem
17.
Support Care Cancer ; 24(9): 3847-55, 2016 09.
Artigo em Inglês | MEDLINE | ID: mdl-27075674

RESUMO

PURPOSE: Radiotherapy-related dermatological toxicities over time have not been well quantified. We examined during and immediately following radiation therapy skin toxicities over time in a randomized study of mometasone furoate vs placebo during breast radiotherapy. MATERIAL AND METHODS: Patients with breast cancer undergoing radiotherapy to the breast or chest wall were randomized. Symptoms related to skin toxicity were addressed weekly using provider-reported Common Terminology Criteria for Adverse Events (CTCAE v3.0) and 4 patient-reported outcomes (PRO) surveys. We applied repeated measures and risk analysis methodologies. RESULTS: One hundred seventy-six patients were enrolled. By CTCAE, significant differences favoring mometasone were detected over time in all toxicities except skin striae, atrophy, and infection. Statistically significant differences between arms at baseline but not over time occurred for all Linear Analog Self-Assessment. Statistically significant differences occurred for all symptoms in the temporal profile of symptoms as measured by PRO surveys (all P < .001). CONCLUSIONS: The use of longitudinal methods enhanced the ability of PRO tools to detect differences between study arms. Our results strengthened the conclusions of the original report that mometasone reduced acute skin toxicities. PRO surveys can accurately assess patients' experiences of symptom type and intensity over time and should be included in future clinical trials. For radiotherapy-related dermatological toxicity, we hypothesized that clinically significant differences over time, if any, can be found by repeated measures. We examined the acute skin toxicities in a randomized study of mometasone vs placebo during breast radiotherapy. For secondary end points, we showed that longitudinal methods enhanced the detection of differences between study arms and strengthened the conclusions from the original report. Frequent patient-reported outcome surveys over time should be included in future clinical trials.


Assuntos
Neoplasias da Mama/complicações , Furoato de Mometasona/efeitos adversos , Idoso , Neoplasias da Mama/radioterapia , Feminino , Humanos , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Fatores de Risco , Resultado do Tratamento
18.
Rare Tumors ; 7(3): 5834, 2015 Sep 07.
Artigo em Inglês | MEDLINE | ID: mdl-26500728

RESUMO

Human T-cell lymphoma virus (HTLV)-associated adult T-cell leukemia lymphoma is a rare cancer in the United States, but there are several areas around the world where the virus is endemic. HTLV-associated adult T-cell leukemia lymphoma has been associated with leukemic arthropathy. We present a patient with HTLV-associated adult T-cell leukemia lymphoma with leukemic arthropathy. Although non-steroidal anti-inflammatory drugs and chemotherapy are often used for treatment, we describe the successful use of radiation therapy in the palliative relief of symptoms from leukemic arthropathy.

19.
Minn Med ; 98(11-12): 44-7, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26720942

RESUMO

Many incoming medical and undergraduate students seek out international medical mission trips to supplement their education and training. However, few have the necessary skills to perform simple clinical tasks such as taking vital signs or conducting an initial patient interview. We conducted a small pilot study to assess the impact of simulation exercises on teaching incoming first-year medical students and undergraduate students basic clinical skills and teamwork. Our study population consisted of nine incoming medical students and 11 undergraduate students who participated in a training session involving simulated tasks prior to taking a medical mission trip to Nicaragua. Participants completed a survey before and after the simulation and at the end of the trip. All 20 indicated the simulation was effective in teaching clinical and team-building skills. In addition, the simulation exercise improved participants' confidence in their ability to perform certain clinical tasks and work as a team prior to the mission trip. We concluded that simulation is effective for incoming medical and undergraduate students and can be used prior to global health trips to increase their confidence in performing tasks required for a successful experience.


Assuntos
Competência Clínica , Currículo , Educação de Graduação em Medicina , Educação Médica , Intercâmbio Educacional Internacional , Missões Médicas , Simulação de Paciente , Adolescente , Atitude do Pessoal de Saúde , Feminino , Humanos , Masculino , Minnesota/etnologia , Multilinguismo , Nicarágua , Equipe de Assistência ao Paciente , Adulto Jovem
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