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1.
J Clin Oncol ; 40(27): 3115-3119, 2022 09 20.
Article in English | MEDLINE | ID: mdl-35960897

ABSTRACT

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned coprimary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.The purpose of this update was to determine differences in patient-reported chronic toxicity and disease outcomes with intensity-modulated radiation therapy (IMRT) compared with conventional pelvic radiation. Patients with cervical and endometrial cancers who received postoperative pelvic radiation were randomly assigned to conventional radiation therapy (CRT) or IMRT. Toxicity and quality of life were assessed using Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, Expanded Prostate Cancer Index Composite (EPIC) bowel and urinary domains, and Functional Assessment of Cancer Therapy-General. Between 2012 and 2015, 279 eligible patients were enrolled to the study with a median follow-up of 37.8 months. There were no differences in overall survival (P = .53), disease-free survival (P = .21), or locoregional failure (P = .81). One year after RT, patients in the CRT arm experienced more high-level diarrhea frequency (5.8% IMRT v 15.1% CRT, P = .042) and a greater number had to take antidiarrheal medication two or more times a day (1.2% IMRT v 8.6% CRT, P = .036). At 3 years, women in the CRT arm reported a decline in urinary function, whereas the IMRT arm continued to improve (mean change in EPIC urinary score = 0.5, standard deviation = 13.0, IMRT v -6.0, standard deviation = 14.3, CRT, P = .005). In conclusion, IMRT reduces patient-reported chronic GI and urinary toxicity with no difference in treatment efficacy at 3 years.


Subject(s)
Radiation Injuries , Radiotherapy, Conformal , Radiotherapy, Intensity-Modulated , Antidiarrheals , Female , Humans , Male , Patient Reported Outcome Measures , Quality of Life , Radiation Injuries/epidemiology , Radiation Injuries/etiology , Radiation Injuries/prevention & control , Radiotherapy, Conformal/adverse effects , Radiotherapy, Intensity-Modulated/adverse effects , Radiotherapy, Intensity-Modulated/methods
2.
J Clin Oncol ; 38(15): 1685-1692, 2020 05 20.
Article in English | MEDLINE | ID: mdl-32073955

ABSTRACT

PURPOSE: In oncology trials, the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) is the standard tool for reporting adverse events (AEs), but it may underreport symptoms experienced by patients. This analysis of the NRG Oncology RTOG 1203 compared symptom reporting by patients and clinicians during radiotherapy (RT). PATIENTS AND METHODS: Patients with cervical or endometrial cancer requiring postoperative RT were randomly assigned to standard 4-field RT or intensity-modulated RT (IMRT). Patients completed the 6-item patient-reported outcomes version of the CTCAE (PRO-CTCAE) for GI toxicity assessing abdominal pain, diarrhea, and fecal incontinence at various time points. Patients reported symptoms on a 5-point scale. Clinicians recorded these AEs as CTCAE grades 1 to 5. Clinician- and patient-reported AEs were compared using McNemar's test for rates > 0%. RESULTS: Of 278 eligible patients, 234 consented and completed the PRO-CTCAE. Patients reported high-grade abdominal pain 19.1% (P < .0001), high-grade diarrhea 38.5% (P < .0001), and fecal incontinence 6.8% more frequently than clinicians. Similar effects were seen between grade ≥ 1 CTCAE toxicity and any-grade patient-reported toxicity. Between-arm comparison of patient-reported high-grade AEs revealed that at 5 weeks of RT, patients who received IMRT experienced fewer GI AEs than patients who received 4-field pelvic RT with regard to frequency of diarrhea (18.2% difference; P = .01), frequency of fecal incontinence (8.2% difference; P = .01), and interference of fecal incontinence (8.5% difference; P = .04). CONCLUSION: Patient-reported AEs showed a reduction in symptoms with IMRT compared with standard RT, whereas clinician-reported AEs revealed no difference. Clinicians also underreported symptomatic GI AEs compared with patients. This suggests that patient-reported symptomatic AEs are important to assess in this disease setting.


Subject(s)
Patient Reported Outcome Measures , Radiotherapy, Intensity-Modulated/methods , Female , Humans , Male
3.
Gynecol Oncol ; 154(1): 183-188, 2019 07.
Article in English | MEDLINE | ID: mdl-31104905

ABSTRACT

OBJECTIVE: Women with endometrial or cervical cancer at risk for recurrence receive postoperative radiation therapy (RT). A patient reported outcomes (PRO) instrument to assess bowel and urinary toxicities is the Expanded Prostate Cancer Index Composite (EPIC), which has been validated in men with prostate cancer. As this instrument specifically measures bowel toxicity and the degree to which this is a problem, it was used in NRG Oncology/RTOG 1203 to compare intensity modulated RT (IMRT) to standard RT. This paper reports on the expanded validation of EPIC for use in women receiving pelvic RT. METHODS: In addition to the EPIC bowel domain, urinary toxicity (EPIC urinary domain), patient reported bowel toxicities (PRO-CTCAE) and quality of life (Functional Assessment of Cancer Therapy (FACT)) were completed before, during and after treatment. Sensitivity, reliability and concurrent validity were assessed. RESULTS: Mean bowel and urinary scores among 278 women enrolled were significantly worse during treatment and differed between groups. Acceptable to good reliability for bowel and urinary domain scores were obtained at all time points with the exception of one at baseline. Correlations between function and bother scores within the bowel and urinary domains were consistently stronger than those across domains. Correlations between bowel domain scores and PRO-CTCAE during treatment were stronger than those with the FACT. CONCLUSION: Correlations within and among the instruments indicate EPIC bowel and urinary domains are measuring conceptually discrete components of health. These EPIC domains are valid, reliable and sensitive instruments to measure PRO among women undergoing pelvic radiation.


Subject(s)
Endometrial Neoplasms/radiotherapy , Intestinal Diseases/etiology , Urologic Diseases/etiology , Uterine Cervical Neoplasms/radiotherapy , Adult , Aged , Aged, 80 and over , Endometrial Neoplasms/surgery , Female , Humans , Hysterectomy , Intestinal Diseases/diagnosis , Intestines/radiation effects , Middle Aged , Patient Reported Outcome Measures , Postoperative Care , Quality of Life , Radiation Injuries/diagnosis , Radiotherapy, Intensity-Modulated , Reproducibility of Results , Urethra/radiation effects , Urologic Diseases/diagnosis , Uterine Cervical Neoplasms/surgery
4.
J Clin Oncol ; 36(24): 2538-2544, 2018 08 20.
Article in English | MEDLINE | ID: mdl-29989857

ABSTRACT

Purpose NRG Oncology/RTOG 1203 was designed to compare patient-reported acute toxicity and health-related quality of life during treatment with standard pelvic radiation or intensity-modulated radiation therapy (IMRT) in women with cervical and endometrial cancer. Methods Patients were randomly assigned to standard four-field radiation therapy (RT) or IMRT radiation treatment. The primary end point was change in patient-reported acute GI toxicity from baseline to the end of RT, measured with the bowel domain of the Expanded Prostate Cancer Index Composite (EPIC). Secondary end points included change in patient-reported urinary toxicity, change in GI toxicity measured with the Patient-Reported Outcome Common Terminology Criteria for Adverse Events, and quality of life measured with the Trial Outcome Index. Results From 2012 to 2015, 289 patients were enrolled, of whom 278 were eligible. Between baseline and end of RT, the mean EPIC bowel score declined 23.6 points in the standard RT group and 18.6 points in the IMRT group ( P = .048), the mean EPIC urinary score declined 10.4 points in the standard RT group and 5.6 points in the IMRT group ( P = .03), and the mean Trial Outcome Index score declined 12.8 points in the standard RT group and 8.8 points in the IMRT group ( P = .06). At the end of RT, 51.9% of women who received standard RT and 33.7% who received IMRT reported frequent or almost constant diarrhea ( P = .01), and more patients who received standard RT were taking antidiarrheal medications four or more times daily (20.4% v 7.8%; P = .04). Conclusion Pelvic IMRT was associated with significantly less GI and urinary toxicity than standard RT from the patient's perspective.


Subject(s)
Endometrial Neoplasms/radiotherapy , Radiation Injuries/epidemiology , Radiotherapy/adverse effects , Radiotherapy/methods , Uterine Cervical Neoplasms/radiotherapy , Female , Humans , Patient Reported Outcome Measures , Pelvis/radiation effects , Radiation Injuries/etiology , Radiotherapy, Intensity-Modulated/adverse effects
5.
Pain ; 158(4): 629-636, 2017 04.
Article in English | MEDLINE | ID: mdl-28009633

ABSTRACT

This study examined outcomes and predictors of different types of responses to child pain used by caregivers of youth with chronic disease. Sixty-six children and adolescents (ages 7-18) with juvenile idiopathic arthritis answered questions about pain, pain interference in activities, and mood on a smartphone three times per day for one month, while a caregiver contemporaneously answered questions about their own mood and use of protecting, monitoring, minimizing, or distracting responses to their child's pain. Multilevel models were used to evaluate (a) how a child's pain and pain interference changes after a caregiver uses different types of pain responses; (b) the extent to which caregiver responses to pain vary across days; and (c) whether variability in caregiver responses to pain is predicted by changes in child pain characteristics, child mood, and/or caregiver mood. Results showed that children's pain intensity and pain interference increased following moments when caregivers used more protective responses, whereas children's pain interference decreased following times when caregivers responded with minimizing responses. Caregiver pain responses varied considerably across days, with caregivers responding with more protecting and monitoring responses and fewer minimizing responses at moments when their child reported high levels of pain unpleasantness and pain interference. Caregivers also were found to respond with fewer protective responses at moments when they themselves were in a more positive mood. Implications for clinical recommendations and future studies are discussed.

6.
Clin J Pain ; 32(6): 471-7, 2016 06.
Article in English | MEDLINE | ID: mdl-26340651

ABSTRACT

OBJECTIVES: Sleep is an emerging area of concern in children with juvenile idiopathic arthritis (JIA). Research shows the presence of poor sleep quality and related adverse outcomes in pediatric pain populations, including JIA, but few studies have examined the prospective patterns of association between sleep and associated outcomes. This prospective study evaluated the direction and magnitude of associations between subjective sleep characteristics (sleep quality, difficulty initiating sleep, and sleep duration), pain intensity, and functional limitations in children with JIA. We hypothesized that pain intensity would partially mediate the relationship between sleep and functional limitations. METHODS: Children and adolescents with JIA (n=59; age range, 8 to 18 y) recruited during clinic visits, completed smartphone-based diaries for 1 month. Subjective sleep characteristics were reported each morning; pain and functioning were assessed 3 times daily. RESULTS: As hypothesized, the associations between sleep quality and functional limitations and between difficulty initiating sleep and functional limitations were partially mediated by pain intensity, at any given moment (z=-3.27, P=0.001, z=2.70, P<0.05). Mediation was not detected in a model testing the association between sleep duration, pain intensity, and functional limitations (z=-0.58, P=0.56). DISCUSSION: Results suggest that sleep is integral to understanding the momentary association between pain intensity and functioning in children with JIA.


Subject(s)
Activities of Daily Living/psychology , Arthritis, Juvenile/complications , Arthritis, Juvenile/psychology , Ecological Momentary Assessment , Pain/etiology , Sleep Wake Disorders/etiology , Adolescent , Child , Female , Humans , Male , Pain Measurement , Prospective Studies
7.
Eur J Orthop Surg Traumatol ; 24(8): 1625-8, 2014 Dec.
Article in English | MEDLINE | ID: mdl-24532084

ABSTRACT

The objective of this study was to validate the use of a software platform (Explorys, Inc., Cleveland, OH) by determining whether the association observed between obesity and revision of total knee arthroplasty (TKA) was obtained within this database. Risk of revision in cohorts with a BMI > 30, as well as cohorts with a BMI between 30-35, 35-40 and >40 was compared to patients with a BMI between 18 and 30 (relative risk, RR). Risk in men versus women was examined. From this database, 70,070 patients were identified that had undergone a TKA. Risk of revision increased as a function of BMI; RR achieved significance in the following cohorts: all patients with a BMI > 30, all patients with a BMI > 40, men with a BMI > 30 and men with a BMI > 40. All other subgroups showed increased RR but did not reach significance. In obese patients, RR was greater in men than in women, and the effect was significant in all groups examined except patients with a BMI between 35 and 40. Data from this study contribute to the process of demonstrating the Explorys software platform is a valid and useful method to investigate associations across large populations.


Subject(s)
Arthroplasty, Replacement, Knee/statistics & numerical data , Obesity/complications , Reoperation/statistics & numerical data , Arthroplasty, Replacement, Knee/adverse effects , Body Mass Index , Databases, Factual , Electronic Health Records , Female , Humans , Male , Risk Factors , Sex Factors , United States/epidemiology
8.
Arthritis Rheumatol ; 66(2): 462-9, 2014 Feb.
Article in English | MEDLINE | ID: mdl-24504820

ABSTRACT

OBJECTIVE: To use electronic diaries (e-diaries) to determine whether pain, stiffness, and fatigue continue to be common, disabling symptoms in children with juvenile idiopathic arthritis (JIA) despite the use of aggressive treatments in contemporary medical management. METHODS: Fifty-nine children with JIA (ages 8-18 years) provided ratings of pain, stiffness, and fatigue intensity and functional limitations using a smartphone e-diary 3 times each day for 1 month. Medication information was collected via parent report and checked for accuracy by chart review. Descriptive analyses were conducted to determine typical symptom intensity, frequency, and variability. Multilevel modeling was used to analyze associations between symptoms and functional outcomes and between medication use and symptom intensity. RESULTS: Children reported moments of pain in 66% of e-diary entries. No children were entirely pain-free across the reporting period. In 31% of all e-diary entries the visual analog scale score for pain was >40 (high pain intensity), with 86% of children reporting a high level of pain at least once during the study period. The mean ratings of pain, stiffness, and fatigue intensity were in the mild-to-moderate range. Medication class was not a reliable predictor of differences in symptom intensity, even though 79% of children were prescribed a disease-modifying antirheumatic drug and 47% were prescribed a biologic agent. Moments of higher pain intensity and higher stiffness intensity were each uniquely predictive of higher concurrent functional limitations. CONCLUSION: Self-reported pain, stiffness, and fatigue continue to be common in children with JIA, despite contemporary advances in treatment strategies, including use of biologic agents. These findings are surprisingly consistent with previous results from research using daily paper diaries in the pre-biologics era. There remains a pressing and ongoing need to optimize pain and symptom management in JIA.


Subject(s)
Antirheumatic Agents/therapeutic use , Arthritis, Juvenile/drug therapy , Biological Products/therapeutic use , Electronic Health Records , Fatigue/epidemiology , Medical Records , Pain/epidemiology , Self Report , Activities of Daily Living , Adolescent , Child , Disability Evaluation , Disease Management , Female , Humans , Incidence , Male , Models, Biological , Pain Measurement , Retrospective Studies , Severity of Illness Index , Treatment Outcome
9.
West J Nurs Res ; 36(5): 599-619, 2014 May.
Article in English | MEDLINE | ID: mdl-24309381

ABSTRACT

Young adults with sickle cell disease (SCD) are often stigmatized when they seek care for pain. The purpose of this pilot study was to test an intervention to decrease health-related stigma during care-seeking. Young adults with SCD ages 18 to 35 years (n = 90) were randomized to either the care-seeking intervention (CSI) or an attention control group that participated in life review interviews. The two groups were compared by t tests and longitudinal data analyses on the change from baseline to the last time point in total health-related stigma and health-related stigma by doctors. Findings suggest that the CSI was associated with significant increased awareness of perceived total stigma and stigma by doctors compared with the attention control group. These findings are promising in terms of lessons learned from a pilot intervention that focused on the role communication skills play in decreasing health-related stigma in young adults with SCD.


Subject(s)
Anemia, Sickle Cell/psychology , Stereotyping , Adolescent , Humans , Pain Management/psychology , Pilot Projects , Young Adult
10.
Int J Med Robot ; 10(2): 237-43, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24357199

ABSTRACT

BACKGROUND: The study was performed to establish a level of practice needed for newly-trained residents to maintain robotic surgical skills during periods of robotic inactivity. METHODS: Ten surgical residents were trained to a standardized level of robotic surgery proficiency with inanimate models. At the end of two, four and six weeks, the residents practiced with the models for a total of one hour. Each resident performed a timed tissue closure task immediately after reaching the proficiency standards and twice in succession at eight weeks. Time to completion was compared between the three trials with a repeated measures ANOVA and a post-hoc test. RESULTS: Average time to complete the tissue closure task decreased by more than 25% over the period between reaching the proficiency standards and the trials at eight weeks, with the difference significant (P < 0.004). CONCLUSIONS: Biweekly practice for one hour was sufficient to maintain robotic surgical skills.


Subject(s)
Robotic Surgical Procedures/education , Clinical Competence , Computer-Assisted Instruction/methods , Curriculum , Female , Humans , Internship and Residency , Male , Models, Anatomic
11.
J Robot Surg ; 8(3): 261-8, 2014 Sep.
Article in English | MEDLINE | ID: mdl-27637688

ABSTRACT

Periodic practice is needed for newly trained robotic surgeons to maintain skills during periods of robotic inactivity. The current study was performed to determine whether virtual robotic skill maintenance can serve as an adequate substitute for practice on a surgical robot. Eleven surgical residents with no prior robotic training were trained to a level of robotic proficiency with inanimate models, including a needle driving pad, a running suture pad, and ring placement on a rocking peg board. After reaching proficiency, each resident was tested on a complex tissue closure task. For the next 8 weeks, the only robotic activity was biweekly virtual robotic skills maintenance. After 8 weeks, the residents performed the tissue closure task twice with the robot, followed by evaluation on the inanimate models used to reach proficiency. Repeated-measures statistical analyses were used to compare between the three tissue closure trials and between the final test at week 0 and the evaluation at week 8 for the other inanimate models. Time to complete the tissue closure task was more than 20 % lower for the second evaluation at 8 weeks than for the other two trials (p < 0.05). Residents maintained their skills for needle driving, but times for suture running and rocking peg board increased by more than 20 % at 8 weeks (p < 0.01). Virtual practice shows promise for maintaining robotic skills. Following a warm-up period, some skills may actually improve with biweekly virtual practice, but skill retention is selective, so further improvements are needed.

12.
Oncol Nurs Forum ; 40(1): 82-92, 2013 Jan.
Article in English | MEDLINE | ID: mdl-23269773

ABSTRACT

PURPOSE/OBJECTIVES: To determine whether breast cancer survivors (BCSs) who received an uncertainty management intervention, compared to an attention control condition, would have less uncertainty, better uncertainty management, fewer breast cancer-specific concerns, and more positive psychological outcomes. DESIGN: A 2 × 2 randomized block, repeated-measures design, with data collected at baseline and two other points postintervention, as well as a few days before or after either a mammogram or oncologist visit. SETTING: Rural and urban clinical and community settings. SAMPLE: 313 female BCSs aged 50 or younger; 117 African Americans and 196 Caucasians. METHODS: Participants were blocked on ethnicity and randomly assigned to intervention or control. The intervention, consisting of a scripted CD and a guide booklet, was supplemented by four scripted, 20-minute weekly training calls conducted by nurse interventionists. The control group received the four scripted, 20-minute weekly training calls. MAIN RESEARCH VARIABLES: Uncertainty in illness, uncertainty management, breast cancer-specific concerns, and positive psychological outcomes. FINDINGS: BCSs who received the intervention reported reductions in uncertainty and significant improvements in behavioral and cognitive coping strategies to manage uncertainty, self-efficacy, and sexual dysfunction. CONCLUSIONS: The intervention was effective as delivered in managing uncertainties related to being a younger BCS. IMPLICATIONS FOR NURSING: The intervention can realistically be applied in practice because of its efficient and cost-effective nature requiring minimal direct caregiver involvement. The intervention allows survivors who are having a particular survival issue at any given point in time to access information, resources, and management strategies. KNOWLEDGE TRANSLATION: Materials tested in CD and guide booklet format could be translated into online format for survivors to access as issues arise during increasingly lengthy survivorship periods. Materials could be downloaded to a variety of electronic devices, fitting with the information needs and management styles of younger BCSs.


Subject(s)
Black or African American/psychology , Breast Neoplasms/nursing , Breast Neoplasms/psychology , Pamphlets , Survivors/psychology , White People/psychology , Adaptation, Psychological , Adult , Black or African American/ethnology , Age Factors , Breast Neoplasms/ethnology , Cognitive Behavioral Therapy/methods , Female , Humans , Mammography/psychology , Middle Aged , Oncology Nursing/methods , Program Evaluation , Rural Health Services , Self Efficacy , Uncertainty , Urban Health Services , White People/ethnology
13.
J Pain Symptom Manage ; 43(6): 1082-93, 2012 Jun.
Article in English | MEDLINE | ID: mdl-22579409

ABSTRACT

CONTEXT: Sickle cell disease (SCD) is an inherited hematological disease marked by intense pain. Early in life the pain is episodic, but it becomes increasingly chronic in many cases. Little is known about this emergence of a chronic pain state. OBJECTIVES: The goal of this study was to determine whether adult SCD patients whose pain is still largely episodic show early signs of the disturbed pain processing (hyperalgesia and increased temporal summation) and cognition (hypervigilance and catastrophizing) that are characteristic of a chronic pain state. METHODS: SCD patients (n=22) and healthy controls (n=52) received noxious pressure stimulation for up to three minutes and periodically reported pain intensity and unpleasantness on 0-10 scales, allowing the rate of pain increase (temporal summation) to be determined. Pain intensity discrimination also was measured, and attitudes toward pain were assessed. RESULTS: There were no overall differences in pain ratings or temporal summation between patient and control groups. However, patients' experimental pain ratings tended to increase with age and those reporting a history of very painful episodes showed particularly rapid temporal summation of pain unpleasantness. Patients were significantly impaired at discriminating intensities of noxious stimulation. Patients were more hypervigilant than controls, but catastrophizing was elevated only during pain episodes. CONCLUSION: Most SCD patients whose pain remits entirely between episodes are not in a chronic pain state, but some--those who are older and have a history of highly painful episodes--appear to be transitioning into it. These early signs of disturbed processing may aid clinicians seeking to forestall disease progression.


Subject(s)
Anemia, Sickle Cell/complications , Anemia, Sickle Cell/diagnosis , Chronic Pain/diagnosis , Chronic Pain/etiology , Pain Measurement/methods , Adult , Early Diagnosis , Female , Humans , Male , Reproducibility of Results , Sensitivity and Specificity
14.
Health Psychol ; 31(2): 202-9, 2012 Mar.
Article in English | MEDLINE | ID: mdl-21842997

ABSTRACT

OBJECTIVE: Children with arthritis experience frequent pain, but the predictors of daily pain variations are largely unidentified. The goal of this study was to examine sleep quality as a predictor of pain in children with arthritis and to determine whether mood moderates this relationship. METHOD: In this prospective, longitudinal study children with polyarticular arthritis (n = 51, ages 8-16 years) tracked daily symptoms, including sleep quality over 2 months. Self-reported daily pain intensity, as indicated on a visual analog scale, was used as the primary outcome measure in multilevel models. RESULTS: Poorer sleep quality was associated with higher next-day pain ratings (p < .01). Mood moderated this relationship such that as positive mood increased, the relationship between poor sleep quality and high pain weakened (p < .01). Daily pain did not predict nightly sleep quality (p > .05). CONCLUSIONS: Sleep quality is an important predictor of pain in children with arthritis. These findings add to the growing body of literature on the use of daily diaries for analyzing patterns of pain, sleep, and mood in children with chronic painful conditions.


Subject(s)
Arthritis, Juvenile/physiopathology , Arthritis, Juvenile/psychology , Pain/psychology , Sleep Wake Disorders/psychology , Adolescent , Affect , Arthritis, Juvenile/complications , Child , Chronic Disease , Family , Female , Humans , Longitudinal Studies , Male , Outcome Assessment, Health Care , Pain/etiology , Pain Measurement , Prospective Studies , Sleep , Sleep Wake Disorders/etiology
15.
JSLS ; 16(2): 218-28, 2012.
Article in English | MEDLINE | ID: mdl-23477169

ABSTRACT

BACKGROUND AND OBJECTIVES: The degradation in robotic skills that occurs during periods of robotic surgical inactivity in newly trained surgeons was measured. The role of animate training in robotic skill was also assessed. METHODS: Robotically naive resident and attending surgeons underwent training with the da Vinci robot on needle passage (DN), rocking ring transfer peg board (RPB), and running suture pod tasks (SP). Errors were established to convert actual time to adjusted time. Participants were deemed "proficient" once their adjusted times were within 80% of those set by experienced surgeons through repeated trials. Participants did not use the robot except for repeating the tasks once at 4, 8, and 12 weeks (tests). Participants then underwent animate training and completed a final test within 7 days. RESULTS: Twenty-five attending and 29 resident surgeons enrolled; 3 withdrew. There were significant increases in time to complete each of the tasks, and in errors, by 4 weeks (Adjusted times: DN: 122.9 +/- 2.2 to 204.2 +/- 11.7, t = 6.9, P < .001; RPB: 262.4 +/- 2.5 to 364.7 +/- 8.0, t = 12.4, P < .001; SP: 91.4 +/- 1.4 to 169.9 +/- 6.8, t = 11.3, P < .001). Times decreased following animate training, but not to levels observed after proficiency training for the RPB and SP modules. CONCLUSIONS: Robotic surgical skills degrade significantly within 4 weeks of inactivity in newly trained surgeons. Animate training may provide different skills than those acquired in the dry lab.


Subject(s)
Clinical Competence , General Surgery/education , Gynecology/education , Learning Curve , Obstetrics/education , Robotics , Task Performance and Analysis , Adult , Female , Humans , Male , Suture Techniques/education , Time Factors
16.
Gynecol Oncol ; 124(3): 426-30, 2012 Mar.
Article in English | MEDLINE | ID: mdl-22075241

ABSTRACT

OBJECTIVE: The majority of women who have had endometrial cancer remain at risk for obesity related diseases. The social cognitive theory was used to explore their beliefs about exercise to aid in the development of effective interventions. METHODS: Women who had been treated for Stage I endometrial cancer were asked about their level of exercise to determine if they had been exercising regularly for more than 6 months (exercisers vs non-exercisers). They were asked to rate the likelihood that exercise would result in various health outcomes (expectations) and to rate the importance of these outcomes (expectancies). Scores for how likely exercise would result in an outcome of importance were calculated. Height and weight were obtained from nurses for calculation of BMI. Statistics were conducted using SPSS v 15. RESULTS: There were 106 valid questionnaires (86% participation rate); 41% were exercisers. Mean BMI was significantly lower in exercisers (31.6 ± 1.2 vs. 37.3 ± 1.2, p=0.001); a significantly greater proportion reported not having diabetes, heart disease or hypertension (69.8% vs. 49.2%, p=0.035). Exercisers were significantly more likely to report that feeling better physically and emotionally versus reducing the risk of diseases were likely and important outcomes of exercise (18.2 ± 0.8 vs 15.0 ± 1.0, p=0.002). CONCLUSIONS: Exercisers identified outcomes of exercise that are more immediate and subjective as being important and likely outcomes of exercise. Focusing on these aspects of exercise (feeling better physically and emotionally) may aid in the development of effective interventions for non-exercisers.


Subject(s)
Endometrial Neoplasms/physiopathology , Endometrial Neoplasms/psychology , Exercise/physiology , Exercise/psychology , Body Mass Index , Endometrial Neoplasms/pathology , Endometrial Neoplasms/surgery , Female , Humans , Neoplasm Staging , Surveys and Questionnaires , Survivors
17.
Gynecol Oncol ; 124(3): 379-82, 2012 Mar.
Article in English | MEDLINE | ID: mdl-22119995

ABSTRACT

PURPOSE: To explore the association between baseline quality of life (QOL) scores and overall survival (OS) in ovarian cancer patients receiving adjuvant chemotherapy. METHODS: Patients with stage III ovarian cancer on Gynecologic Oncology Group protocol #172 completed the Functional Assessment of Cancer Therapy-General (FACT-G) and were then randomly assigned to either intravenous (IV) or intraperitoneal (IP) chemotherapy. The FACT scale includes physical, functional, social, and emotional well-being domains (PWB, FWB, SWB, EWB). The PWB item, lack of energy, was used to assess the presence of fatigue. RESULTS: After adjusting for patient age, treatment assignment, and the presence of gross disease, PWB was associated with OS. Patients who reported baseline PWB scores in the lowest 25% (PWB score<15 points) relative to those who scored in the highest 25% (PWB score>24 points) had decreased OS (HR: 1.81; 95% CI: 1.2-2.72; p=0.005). Patients experienced death rates 20% lower for every mean item point increase in PWB (Hazard Ratio [HR]: 0.80; 95% CI: 0.68-0.93; p=0.005). Patients complaining of fatigue did not have an increased risk of death compared with those not feeling fatigued (HR: 1.21; 95% CI: 0.91-1.61; p=0.19). CONCLUSIONS: Poor physical well-being reported at baseline is associated with risk of death in patients undergoing adjuvant chemotherapy for advanced ovarian cancer. Identifying modifiable characteristics that are associated with survival offers the potential for providing support that may improve outcomes.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Ovarian Neoplasms/drug therapy , Ovarian Neoplasms/psychology , Quality of Life , Adult , Aged , Chemotherapy, Adjuvant , Cisplatin/administration & dosage , Fatigue/etiology , Fatigue/psychology , Female , Humans , Infusions, Intravenous , Infusions, Parenteral , Middle Aged , Neoplasm Staging , Ovarian Neoplasms/pathology , Ovarian Neoplasms/surgery , Paclitaxel/administration & dosage , Survival Rate
18.
J Pediatr Psychol ; 37(1): 43-52, 2012.
Article in English | MEDLINE | ID: mdl-22037006

ABSTRACT

OBJECTIVES: This study utilized e-diaries to evaluate whether components of emotion regulation predict daily pain and function in children with juvenile idiopathic arthritis (JIA). METHODS: 43 children ages 8-17 years and their caregivers provided baseline reports of child emotion regulation. Children then completed thrice daily e-diary assessments of emotion, pain, and activity involvement for 28 days. E-diary ratings of negative and positive emotions were used to calculate emotion variability and to infer adaptive emotion modulation following periods of high or low emotion intensity. Hierarchical linear models were used to evaluate how emotion regulation related to pain and function. RESULTS: The attenuation of negative emotion following a period of high negative emotion predicted reduced pain; greater variability of negative emotion predicted higher pain and increased activity limitation. Indices of positive emotion regulation also significantly predicted pain. CONCLUSIONS: Components of emotion regulation as captured by e-diaries predict important health outcomes in children with JIA.


Subject(s)
Activities of Daily Living/psychology , Adaptation, Psychological , Arthritis, Juvenile/psychology , Emotions/physiology , Pain/psychology , Adolescent , Child , Cross-Sectional Studies , Female , Humans , Male , Pain Measurement/psychology
19.
Obstet Gynecol Int ; 2011: 308609, 2011.
Article in English | MEDLINE | ID: mdl-22135678

ABSTRACT

Objective. Most women with type I endometrial cancer (EC) are obese, increasing the risk of morbidity and mortality in this population. The study objective was to evaluate the impact of obesity on quality of life (QOL) and general health status in EC survivors with early-stage disease. Methods. A prospective ancillary analysis of stage I/II EC survivors. The association of BMI with QOL questionnaire variables measured with the functional assessment of cancer therapy (subscales: physical (PWB), functional (FWB), social, and emotional well-being) and the physical (PCS) and mental component summary subscales of the short-form medical outcomes survey was determined. Results. 152 women completed both questionnaires; 81% were obese. After multiple linear regression, BMI was inversely associated with PWB (P = .001), FWB (P = 0.048), and PCS (P = .001). Conclusions. Despite the good prognosis associated with early-stage EC, QOL, and physical health are not optimized in obese survivors. This paper highlights the importance of incorporating health-related QOL assessments and obesity interventions during the survivorship period.

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