ABSTRACT
OBJECTIVES: In a prospective study of platinum-resistant ovarian cancer patients, we examined whether the Disease-related Symptoms-Physical (DRS--P) scale of the NCCN/FACT-Ovarian Cancer Symptom Index-18 (NFOSI-18) is responsive to clinical change in patients estimated by their provider to survive at least six months. METHODS: The NFOSI-18, and other FACT measures, was collected at study entry and 3 and 6 months post-enrollment. Measures were compared for those who died or dropped off study prior to 3 months or prior to 6 months (assumed as health deterioration over time), or those who stayed on study through 6 months (presumed as stable disease over time). Statistical analyses included a fitted linear mixed model for estimating the group differences over time, Cox regression to assess the probability of survival with patient-reported outcomes, and effect size. RESULTS: DRS-P scores of patients who completed only one assessment were significantly lower compared to patients who were able to complete two assessments [5.9 points lower (2.0-9.8); p < 0.01], or three assessments [8.1 points lower (4.8-11.5); p < 0.01]. Measures of abdominal discomfort, functional well-being, emotional well-being, and quality of life were also significant, but treatment side effects were not. Further, in every scale except for neurotoxicity, higher (better) baseline scores were associated with a decreased likelihood of death, after adjusting for age, performance and disease status. CONCLUSION: The NFOSI-18 DRS-P scale is responsive to clinical change. It has potential as an indicator of changing health status with ovarian cancer disease progression, distinct from treatment side effects.
Subject(s)
Antineoplastic Agents/pharmacology , Ovarian Neoplasms/therapy , Patient Reported Outcome Measures , Quality of Life , Terminal Care/methods , Aged , Antineoplastic Agents/therapeutic use , Cancer Survivors/psychology , Cancer Survivors/statistics & numerical data , Disease Progression , Drug Resistance, Neoplasm , Female , Follow-Up Studies , Health Status , Humans , Middle Aged , Neoplasm Recurrence, Local , Ovarian Neoplasms/complications , Ovarian Neoplasms/mortality , Ovarian Neoplasms/psychology , Prospective Studies , Terminal Care/statistics & numerical dataABSTRACT
OBJECTIVES: Depression is one of the most prevalent mental disorders, and rates are higher among cancer survivors than the general population, and higher in ovarian cancer patients compared to cohorts of other cancer survivors. Physical activity has been associated with lower depressive symptoms in cancer survivors, yet no trial has examined this association in women with ovarian cancer. We examined the effect of exercise on depression symptomatology and serum brain derived neurotrophin factor (BDNF) which has been associated with depression, in women with ovarian cancer. METHODS: We conducted a 6-month home-based randomized trial of exercise vs. attention-control (AC) in 144 ovarian cancer survivors. Depressive symptomatology was measured via the Center for Epidemiologic Studies Depression Scale (CES-D). Serum total and free BDNF was measured at baseline and 6-months. Student's t-statistic and mixed-model repeated measures analysis was used to evaluate six-month change between arms in CES-D scores and BDNF. RESULTS: Women were 57.3⯱â¯8.6 (mean⯱â¯SD) years old, 1.7⯱â¯1.0â¯years post-diagnosis with a baseline CES-D score of 11.79⯱â¯10.21. The majority (55%) were diagnosed with stage III/IV ovarian cancer. CES-D scores decreased in the exercise arm by 2.7 points (95% CI: -4.4, -0.9) or a 21% decrease compared to a 0.3 point decrease (-2.2, 1.5) (3% decrease) in the AC arm (Pâ¯=â¯0.05). There was no difference in change in total or free BDNF between the exercise and AC arms. CONCLUSIONS: Ovarian cancer survivors are able to exercise at recommended levels, and exercise was associated with a significant reduction in depressive symptomatology.
Subject(s)
Attention , Brain-Derived Neurotrophic Factor/blood , Cancer Survivors/psychology , Depression/therapy , Exercise , Ovarian Neoplasms/psychology , Behavior Therapy , Connecticut , Depression/blood , Depression/metabolism , Depression/psychology , Female , Humans , Middle Aged , Ovarian Neoplasms/blood , Ovarian Neoplasms/metabolism , Ovarian Neoplasms/rehabilitation , Patient ComplianceSubject(s)
Communication , Coronavirus Infections/prevention & control , Ethics, Medical , Genital Neoplasms, Female/therapy , Infection Control/standards , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Betacoronavirus/pathogenicity , COVID-19 , Coronavirus Infections/epidemiology , Coronavirus Infections/transmission , Coronavirus Infections/virology , Critical Care/ethics , Critical Care/organization & administration , Female , Gynecology/ethics , Gynecology/organization & administration , Humans , Medical Oncology/ethics , Medical Oncology/organization & administration , Palliative Care/ethics , Palliative Care/organization & administration , Pneumonia, Viral/epidemiology , Pneumonia, Viral/transmission , Pneumonia, Viral/virology , Resource Allocation/ethics , SARS-CoV-2 , Standard of CareABSTRACT
PURPOSE: The primary objective was to determine if vaginal cuff brachytherapy and chemotherapy (VCB/C) increases recurrence-free survival (RFS) compared with pelvic radiation therapy (RT) in high-intermediate and high-risk early-stage endometrial carcinoma. PATIENTS AND METHODS: A randomized phase III trial was performed in eligible patients with endometrial cancer. Eligible patients had International Federation of Gynecology and Obstetrics (2009) stage I endometrioid histology with Gynecologic Oncology Group protocol 33-based high-intermediate-risk criteria, stage II disease, or stage I to II serous or clear cell tumors. Treatment was randomly assigned between RT (45 to 50.4 Gy over 5 weeks) or VCB followed by intravenous paclitaxel 175 mg/m2 (3 hours) plus carboplatin (area under the curve, 6) every 21 days for three cycles. RESULTS: The median age of the 601 patients was 63 years, and 74% had stage I disease. Histologies included endometrioid (71%), serous (15%), and clear cell (5%). With a median follow-up of 53 months, the 60-month RFS was 0.76 (95% CI, 0.70 to 0.81) for RT and 0.76 (95% CI, 0.70 to 0.81) for VCB/C (hazard ratio, 0.92; 90% confidence limit, 0.69 to 1.23). The 60-month overall survival was 0.87 (95% CI, 0.83 to 0.91) for RT and 0.85 (95% CI, 0.81 to 0.90) for VCB/C (hazard ratio, 1.04; 90% confidence limit, 0.71 to 1.52). Vaginal and distant recurrence rates were similar between arms. Pelvic or para-aortic nodal recurrences were more common with VCB/C (9% v 4%). There was no heterogeneity of treatment effect with respect to RFS or overall survival among clinical or pathologic variables evaluated. CONCLUSION: Superiority of VCB/C compared with pelvic RT was not demonstrated. Acute toxicity was greater with VCB/C; late toxicity was similar. Pelvic RT alone remains an effective, well-tolerated, and appropriate adjuvant treatment in high-risk early-stage endometrial carcinomas of all histologies.
Subject(s)
Carboplatin/therapeutic use , Endometrial Neoplasms/drug therapy , Endometrial Neoplasms/radiotherapy , Paclitaxel/therapeutic use , Pelvis/radiation effects , Radiotherapy, Adjuvant/methods , Vagina/radiation effects , Adult , Aged , Aged, 80 and over , Brachytherapy/methods , Carboplatin/pharmacology , Endometrial Neoplasms/pathology , Female , Humans , Middle Aged , Neoplasm Staging , Paclitaxel/pharmacology , Prospective Studies , Young AdultABSTRACT
OBJECTIVES: The goals of treating recurrent platinum-resistant ovarian cancer are palliative, aimed at reducing symptoms and improving progression free survival. A prospective trial was conducted to determine the prevalence and severity of symptoms, and associated care needs. METHODS: Eligible women included those with persistent or recurrent platinum-resistant ovarian cancer with an estimated life expectancy of at least 6â¯months. The Needs at the End-of-Life Screening Tool (NEST), FACIT-Fatigue (FACIT-F), NCCN-FACT Ovarian Symptom Index [NFOSI-18]; Disease Related Symptoms (DRS), Treatment Side Effects (TSE), and Function/Well Being (F/WB) were collected at study entry, 3 and 6â¯months. RESULTS: We enrolled 102 evaluable patients. Initiation of Do Not Resuscitate (DNR) discussions increased over time from 28% at study entry to 37% at 6â¯months. At study entry, the most common disease-related symptoms were fatigue (92%), worry (89%), and trouble sleeping (76%); 73% reported being "bothered by treatment side effects", which included nausea (41%) and hair loss (51%) neither of which changed over time. The most common NEST unmet needs were in the symptom dimension. The social dimension was associated with F/WB (pâ¯=â¯0.002) and FACIT-F (pâ¯=â¯0.006); symptoms were associated with DRS (pâ¯=â¯0.04), TSE (pâ¯=â¯0.03), and FACIT-F (pâ¯=â¯0.04); existential was not associated with any of the patient-reported symptoms; therapeutic was associated with F/WB (pâ¯=â¯0.02). CONCLUSIONS: In patients nearing the end of life, there are significant associations between disease and treatment related symptoms and unmet patient needs, which do not change substantially over time. Careful exploration of specific end-of-life care needs can improve patient-centered care and QOL.
Subject(s)
Ovarian Neoplasms/therapy , Quality of Life/psychology , Aged , Aged, 80 and over , Female , Humans , Middle Aged , Ovarian Neoplasms/psychologyABSTRACT
For the last few months, media and news outlets have exposed prominent professionals in many settings who have taken advantage of their status of power and influence to engage in sexual harassment and discrimination in the workplace. In medicine, harassment may include many types of health professionals including physicians, nurses, medical students, colleagues and even patients. Programs for sexual harassment prevention, education and training vary between industries, workplaces, medical schools and hospitals. It is imperative to engage men and women in awareness, education, empowerment of the bystander and movement for cultural change. A grass roots effort should be started by each of us to reach out to our academic institutions, health systems and private practices to review policy, education and codes of conduct. We have the ability to embrace improvement around gender and diversity in our words and actions.
Subject(s)
Genital Neoplasms, Female/psychology , Sexual Harassment/psychology , Women's Health , Female , Genital Neoplasms, Female/etiology , Genital Neoplasms, Female/therapy , Health Personnel , Humans , Male , Occupational Stress/etiology , Occupational Stress/psychology , Sexism , WorkplaceABSTRACT
PURPOSE: A simple measure to predict chemotherapy tolerance in elderly patients would be useful. We prospectively tested the association of baseline Instrumental Activities of Daily Living (IADL) score with ability to complete 4 cycles of first line chemotherapy without dose reductions or >7days delay in elderly ovarian cancer patients. PATIENTS AND METHODS: Patients' age ≥70 along with their physicians chose between two regimens: CP (Carboplatin AUC 5, Paclitaxel 135mg/m2) or C (Carboplatin AUC 5), both given every 3weeks either after primary surgery or as neoadjuvant chemotherapy (NACT) with IADL and quality of life assessments performed at baseline, pre-cycle 3, and post-cycle 4. RESULTS: Two-hundred-twelve women were enrolled, 152 selecting CP and 60 selecting C. Those who selected CP had higher baseline IADL scores (p<0.001). After adjusting for age and PS, baseline IADL was independently associated with the choice of regimen (p=0.035). The baseline IADL score was not found to be associated with completion of 4 cycles of chemotherapy without dose reduction or delays (p=0.21), but was associated with completion of 4 cycles of chemotherapy regardless of dose reduction and delay (p=0.008) and toxicity, with the odds ratio (OR) of grade 3+ toxicity decreasing 17% (OR: 0.83; 95%CI: 0.72-0.96; p=0.013) for each additional activity in which the patient was independent. After adjustment for chemotherapy regimen, IADL was also associated with overall survival (p=0.019) for patients receiving CP. CONCLUSION: Patients with a higher baseline IADL score (more independent) were more likely to complete 4 cycles of chemotherapy and less likely to experience grade 3 or higher toxicity.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Fallopian Tube Neoplasms/drug therapy , Ovarian Neoplasms/drug therapy , Peritoneal Neoplasms/drug therapy , Age Factors , Aged , Aged, 80 and over , Fallopian Tube Neoplasms/pathology , Female , Humans , Ovarian Neoplasms/pathology , Peritoneal Neoplasms/pathologyABSTRACT
Background: Ovarian cancer survivors experience a wide range of treatment side effects that can negatively affect health-related quality of life (HRQOL). Physical activity has been shown to improve HRQOL and cancer-related fatigue (CRF) for other cancer survivors; however, no large randomized controlled trial (RCT) has been conducted for ovarian cancer. Methods: This study examined the impact of a six-month RCT of exercise vs attention control on change in HRQOL (Short Form Health Survey-36) and CRF (Functional Assessment of Cancer Therapy-Fatigue Scale) in ovarian cancer survivors. Women (n = 144) were randomly assigned to study arms between May 1, 2010, and March 20, 2014. All statistical tests were two-sided. Results: A total of 74 women were randomly assigned to exercise and 70 to attention control. A total of 113 (78.5%) of the participants completed the six-month assessment. Adherence to the exercise intervention was excellent (166.0±66.1 minutes/week in the exercise arm). At six months, women in the exercise arm had improved physical HRQOL (SF-36 Physical Component Summary Score) compared with the control arm, 1.8 (SD = 1.1) vs -2.0 (SD = 1.2) , respectively (group difference = 3.7, SD = 1.2, 95% confidence interval [CI] = 0.7 to 6.8, P = .02). No group differences were seen for change in mental HRQOL. There was a statistically significant improvement in the fatigue score (Functional Assessment of Cancer Therapy-Fatigue) for exercisers (4.0, SD = 1.1, 95% CI = 1.8 to 6.2, P < .001) but not for controls (1.2, SD = 1.2, 95% CI = -1.1 to 3.5, P = .31), with a between-group difference of 2.8 (SD = 1.5, 95% CI = -0.2 to 5.7, P = .06). Conclusions: We found a six-month home-based, telephone-delivered exercise intervention of primarily brisk walking to be associated with improved physical HRQOL in women with ovarian cancer. Given that higher HRQOL and exercise have both been associated with overall survival in women diagnosed with ovarian cancer, oncologists and primary care providers should recommend and refer women diagnosed with ovarian cancer to clinic- or community-based exercise programs.
Subject(s)
Exercise , Life Style , Ovarian Neoplasms/rehabilitation , Ovarian Neoplasms/therapy , Quality of Life , Survivors , Connecticut , Female , Humans , Middle AgedABSTRACT
OBJECTIVE: To evaluate the association between body mass index (BMI) and mortality in women with endometrial cancer. METHODS: A systematic review was performed utilizing a Medline search with Mesh keywords 'endometrial neoplasms' and ('body mass index' or 'obesity') and ('survival analysis' or 'mortality' or 'survivor' or 'survival') for studies published prior to June 2013. Inclusion criteria included studies that assessed associations between BMI and survival in endometrial cancer patients. Two investigators independently reviewed the title and abstract and full-text of articles for inclusion or exclusion decision; discordant decisions were adjudicated by a third reviewer. A random-effects model was constructed that was comparable to the standard random-effects models used in the meta-analysis of odds ratios. The model was fitted using SAS PROC NLMIXED. RESULTS: 1451 studies were identified and reviewed in duplicate, 18 met inclusion criteria. A random-effects meta-analysis demonstrated significantly higher odds of mortality with increasing BMI in endometrial cancer patients. Specifically the odds ratios were 1.01, 1.17, 1.26, and 1.66 for BMI categories of 25-29.9, 30-34.9, 35-39.9, and 40+, respectively. The odds ratio for all-cause mortality in endometrial cancer patients with a BMI≥40 compared to those with a BMI<25 was 1.66 (CI: 1.10-2.51, p=0.02). A single dose-response model indicated that a 10% increase in BMI resulted in a 9.2% increase in the odds of all-cause mortality (p=0.007). CONCLUSION: Increased BMI is significantly associated with increased all-cause mortality in women with endometrial cancer, with the highest risk for those with a BMI≥40.
Subject(s)
Body Mass Index , Endometrial Neoplasms/mortality , Female , HumansABSTRACT
OBJECTIVE: History of fast labor is currently subjectively defined and inductions for non-medical indications are becoming restricted. We hypothesized that women induced for a history of fast labor do not have faster previous labors and do not deliver more quickly. METHODS: A retrospective case-control cohort design studied multiparas undergoing elective induction at one high risk center. Outcomes of dyads electively induced for a history of previous fast labor indication (PFast) were compared to controls with a psychosocial indication. RESULTS: A total of 612 elective inductions with 1074 previous deliveries were evaluated: 81 (13%) PFast and 531 (87%) control. PFast had faster previous labors (median 5.5 h, IQR: 4.5-6) versus. control (10 h, IQR: 9-10.5; p < 0.001). Subsequent delivery time from start to expulsion was shorter for PFast (median 7 h, IQR: 5-9, p < 0.001) than controls with and without a previous labor <5.5 h (8.6 h, IQR: 6-14 and 9.5 h, IQR: 7-15, respectively). PFast were less likely to have a serious maternal complication. Neonatal complications were similar. CONCLUSIONS: Patients induced for a history of fast labor do have faster previous labors, suggesting a significant history of fast labor can be defined as <5.5 h. These women deliver more quickly and with lower morbidity than controls when subsequently induced, therefore the benefit may warrant the risk for a select number of women with a history of a prior labor length <5.5 h.
Subject(s)
Labor, Induced/statistics & numerical data , Labor, Obstetric , Adult , Female , Humans , Labor, Induced/adverse effects , Pregnancy , Retrospective Studies , Time Factors , Young AdultABSTRACT
To address surgical complications, the World Health Organization (WHO) developed the Safe Surgery Saves Lives Checklist. With the foundation of the WHO's checklist, a robotic-specific checklist (RORCC) was developed using standardized content and face validity methods. The RORCC was implemented in a high volume gynecological (GYN) specialty group using minimally invasive robotic-assisted surgery. Data were abstracted from patients undergoing GYN procedures from four GYN surgeons at an urban, community hospital during November 16, 2010 to May 15, 2011 (pre-RORCC) n = 89 and from the period May 16, 2011 to November 16 2011 (post-RORCC) n = 121. Thirty-day readmissions pre-checklist and post-checklist were 12 and 5, respectively, which is a significant (p = 0.02) reduction. The duration of surgery was not significantly affected (p = 0.40) with pre-RORCC surgery time at 110.1 (35.7) min versus post-RORCC surgery time at 112.9 (37.4) min. This study demonstrated the feasibility of integrating an electronic, interactive, and robotic-specific checklist for gynecologic robotic-assisted surgery which resulted in a significant reduction in readmissions at the 30-day without significantly impacting operating room times.
Subject(s)
Hysterectomy/standards , Patient Safety/standards , Robotic Surgical Procedures/standards , Adult , Checklist , Humans , Hysterectomy/methods , Hysterectomy/statistics & numerical data , Middle Aged , Prospective Studies , Robotic Surgical Procedures/methods , Robotic Surgical Procedures/statistics & numerical dataABSTRACT
Chronic pelvic pain affects multiple aspects of a patient's physical, social, and emotional functioning. Latent class analysis (LCA) of Patient Reported Outcome Measures Information System (PROMIS) domains has the potential to improve clinical insight into these patients' pain. Based on the 11 PROMIS domains applied to n=613 patients referred for evaluation in a chronic pelvic pain specialty center, exploratory factor analysis (EFA) was used to identify unidimensional superdomains. Latent profile analysis (LPA) was performed to identify the number of homogeneous classes present and to further define the pain classification system. The EFA combined the 11 PROMIS domains into four unidimensional superdomains of biopsychosocial dysfunction: Pain, Negative Affect, Fatigue, and Social Function. Based on multiple fit criteria, a latent class model revealed four distinct classes of CPP: No dysfunction (3.2%); Low Dysfunction (17.8%); Moderate Dysfunction (53.2%); and High Dysfunction (25.8%). This study is the first description of a novel approach to the complex disease process such as chronic pelvic pain and was validated by demographic, medical, and psychosocial variables. In addition to an essentially normal class, three classes of increasing biopsychosocial dysfunction were identified. The LCA approach has the potential for application to other complex multifactorial disease processes.
ABSTRACT
OBJECTIVE: The study aimed to assess a one-month lifestyle intervention delivered via a web- and mobile-based weight-loss application (app) (LoseIt!) using a healthcare-provider interface. METHODS: Early-stage overweight/obese (body mass index [BMI]≥25kg/m(2)) cancer survivors (CS) diagnosed in the past three years, and without recurrent disease were enrolled and received exercise and nutrition counseling using the LoseIt! app. Entry and exit quality of life (FACT-G) and Weight Efficacy Lifestyle Questionnaire (WEL) measuring self-efficacy were measured along with anthropometrics, daily food intake, and physical activity (PA) using the app. RESULTS: Mean participant age was 58.4±10.3years (n=50). Significant reductions (p<0.0006) in anthropometrics were noted between pre- and post-intervention weight (105.0±21.8kg versus 98.6±22.5kg); BMI (34.9±8.7kg/m(2) versus 33.9±8.4kg/m(2)); and waist circumference (108.1±14.9cm versus 103.7±15.1cm). A significant improvement in pre- and post-intervention total WEL score was noted (99.38±41.8 versus 120.19±47.1, p=0.043). No significant differences were noted in FACT-G, macronutrient consumption, and PA patterns. CONCLUSION: These results indicate that a lifestyle intervention delivered via a web- and mobile-based weight-loss app is a feasible option by which to elicit short-term reductions in weight. Though these results parallel the recent survivors of uterine cancer empowered by exercise and healthy diet (SUCCEED) trial, it is notable that they were achieved without encumbering significant cost and barrier-access issues (i.e. time, transportation, weather, parking, etc.).
Subject(s)
Breast Neoplasms/therapy , Counseling/methods , Endometrial Neoplasms/therapy , Mobile Applications , Obesity/therapy , Overweight/therapy , Adolescent , Adult , Aged , Diet , Exercise , Feasibility Studies , Female , Humans , Middle Aged , Neoplasm Staging , Prospective Studies , Quality of Life , Surveys and Questionnaires , Survivors , Young AdultABSTRACT
Nearly half of all women diagnosed with breast or ovarian cancer are age 65 years or older with the number of women diagnosed expected to increase as the population ages and life expectancy improves. Older women are less likely to be offered standard cancer treatments, are more likely to develop higher toxicity, and have higher mortality. Chronologic age should not be the only factor used for making treatment decisions. Functional dependence, organ function, comorbidity, polypharmacy, social support, cognitive and/or psychosocial factors, overall life expectancy, and patient's goals of care are equally vital and should be assessed before and during treatment. In this review, current evidence and treatment guidelines for older women with breast or ovarian cancer are outlined.
Subject(s)
Breast Neoplasms/therapy , Ovarian Neoplasms/therapy , Age Factors , Aged , Female , Geriatric Assessment , Humans , Practice Guidelines as TopicABSTRACT
There is no consensus as to what symptoms or quality-of-life (QOL) domains should be measured as patient-reported outcomes (PROs) in ovarian cancer clinical trials. A panel of experts convened by the National Cancer Institute reviewed studies published between January 2000 and August 2011. The results were included in and combined with an expert consensus-building process to identify the most salient PROs for ovarian cancer clinical trials. We identified a set of PROs specific to ovarian cancer: abdominal pain, bloating, cramping, fear of recurrence/disease progression, indigestion, sexual dysfunction, vomiting, weight gain, and weight loss. Additional PROs identified in parallel with a group charged with identifying the most important PROs across cancer types were anorexia, cognitive problems, constipation, diarrhea, dyspnea, fatigue, nausea, neuropathy, pain, and insomnia. Physical and emotional domains were considered to be the most salient domains of QOL. Findings of the review and consensus process provide good support for use of these ovarian cancer-specific PROs in ovarian cancer clinical trials.
Subject(s)
Clinical Trials as Topic/methods , Ovarian Neoplasms/complications , Ovarian Neoplasms/therapy , Quality of Life , Self Report , Anorexia/etiology , Antineoplastic Agents/administration & dosage , Antineoplastic Agents/adverse effects , Clinical Trials as Topic/standards , Clinical Trials as Topic/trends , Constipation/etiology , Diarrhea/etiology , Fatigue/etiology , Female , Health Status , Humans , National Cancer Institute (U.S.) , Nausea/etiology , Ovarian Neoplasms/epidemiology , Ovarian Neoplasms/physiopathology , Ovarian Neoplasms/psychology , Surveys and Questionnaires , Treatment Outcome , United States/epidemiology , Visceral Pain/etiology , Vomiting/etiologyABSTRACT
STUDY OBJECTIVE: To measure the safety culture in the robotics surgery operating room before and after implementation of the Robotic Operating Room Computerized Checklist (RORCC). DESIGN: Prospective study. SUBJECTS: Gynecology surgical staff (n = 32). SETTING: An urban community hospital. INTERVENTIONS: The Safety Attitudes Questionnaire domains examined were teamwork, safety, job satisfaction, stress recognition, perceptions of management, and working conditions. Questions and domains were described using percent agreement and the Cronbach alpha. Paired t-tests were used to describe differences before and after implementation of the checklist. MEASUREMENTS AND MAIN RESULTS: Mean (SD) staff age was 46.7 (9.5) years, and most were women (78%) and worked full-time (97%). Twenty respondents (83% of nurses, 80% of surgeons, 66% of surgical technicians, and 33% of certified registered nurse anesthetists) completed the Safety Attitudes Questionnaire; 6 were excluded because of non-matching identifiers. Before RORCC implementation, the highest quality of communication and collaboration was reported by surgeons and surgical technicians (100%). Certified registered nurse anesthetists reported only adequate levels of communication and collaboration with other positions. Most staff reported positive responses for teamwork (48%; α = 0.81), safety (47%; α = 0.75), working conditions (37%; α = 0.55), stress recognition (26%; α = 0.71), and perceptions of management (32%; α = 0.52). No differences were observed after RORCC implementation. CONCLUSION: Quality of communication and collaboration in the gynecology robotics operating room is high between most positions; however, safety attitude responses are low overall. No differences after RORCC implementation and low response rates may highlight lack of staff support.
Subject(s)
Attitude of Health Personnel , Gynecology , Operating Rooms/standards , Patient Safety , Robotics , Safety Management/organization & administration , Adult , Checklist , Communication , Cooperative Behavior , Female , Gynecology/organization & administration , Gynecology/standards , Humans , Job Satisfaction , Middle Aged , Organizational Culture , Physician-Nurse Relations , Prospective Studies , Safety Management/standards , Surveys and Questionnaires , Total Quality Management/organization & administrationABSTRACT
BACKGROUND/PURPOSE: This study was designed to evaluate the response and toxicity of sorafenib alone or when combined with carboplatin and paclitaxel in patients with platinum-sensitive, recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (EOC). METHODS: Patients with recurrent platinum-sensitive EOC with no more than 2 prior courses of chemotherapy were randomized to single-agent sorafenib 400 mg twice daily or combination sorafenib 400 mg bid (days 2-19) with IV carboplatin (AUC 6) and IV paclitaxel 175 mg/m(2) (S+C/T) every 3 weeks. Single agent sorafenib could cross over to combination upon progression. RESULTS: Patients were initially randomized to either arm, however, due to poor accrual, sorafenib arm was prematurely closed. A total of 13 patients were evaluable for response to sorafenib and 23 patients were evaluable for response to S+C/T. Objective response rate (RR) was 15 % for patients on sorafenib vs. 61 % for patients on S+C/T (p = 0.014); stable disease was seen in 62 % and 35 %, respectively. Clinical benefit rate (CBR) at 4 months (mos.) was 69 % for S and 65 % for S+C/T. The median progression free survival was 5.6 months on sorafenib vs. 16.8 months on S+C/T (p = 0.012) and there was no significant difference of overall survival between two arms (p = 0.974) with median overall survival 25.6 months under sorafenib vs. 25.9 months on S+C/T. Patients remained on trial for a median of 7.8 cycles on sorafenib and 5.4 cycles on S+C/T. CONCLUSION: Sorafenib, alone or in combination with carboplatin and paclitaxel, has activity in patients with platinum-sensitive EOC. Sorafenib in combination with carboplatin and paclitaxel improved RR and PFS; however, there were increased grade and frequencies of toxicities.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Fallopian Tube Neoplasms/drug therapy , Neoplasms, Glandular and Epithelial/drug therapy , Organoplatinum Compounds/therapeutic use , Ovarian Neoplasms/drug therapy , Peritoneal Neoplasms/drug therapy , Aged , Antineoplastic Agents/administration & dosage , Carboplatin/administration & dosage , Carcinoma, Ovarian Epithelial , Disease-Free Survival , Drug Administration Schedule , Female , Humans , Middle Aged , Neoplasm Recurrence, Local/drug therapy , Niacinamide/administration & dosage , Niacinamide/analogs & derivatives , Paclitaxel/administration & dosage , Phenylurea Compounds/administration & dosage , SorafenibABSTRACT
OBJECTIVE: Cesarean is the single most common operation in United States and has reached epidemic proportions in recent decades. Our objective was to study the effect of nonclinical parameters on primary cesarean rates in a large contemporary population. STUDY DESIGN: We designed a retrospective multicenter study using data obtained from electronic medical records from 19 U.S. hospitals between 2005 and 2007 (Consortium on Safe Labor Database), which included 145,764 term, singleton, nonanomalous, vertex, live births that included labor. The impact of nonclinical parameters (patient and provider characteristics, time of delivery, institutional policies, and insurance type) was investigated using modified Poisson regression methodology and classification and regression tree analysis. RESULTS: There were 125,517 vaginal and 20,247 cesarean deliveries. Using the multivariable model, the nonclinical parameters with statistical significance for primary cesarean were delivery during evening hours, a male provider, public insurance, and nonwhite race (p < 0.001). CONCLUSIONS: Cesarean rates are associated with several nonclinical factors. Further investigation into these factors might help to develop strategies to reduce their influence and hence the rates of cesarean.