Patient Perceptions About the Role of Religion and Spirituality During Cancer Care.

We sought to assess the perspectives of cancer patients relative to their spiritual well-being, as well as examine the impact of religion/spirituality during cancer care. A mixed-methods concurrent embedded online survey design was used. While 86% of participants indicated a religious/spiritual belief, respondents also reported lower overall spiritual well-being than population norms (t(73) = - 5.30, p < 0.01). Open-ended responses revealed that 22% of participants desired the healthcare team to address the topic of religion/spirituality, but the majority preferred to discuss with a family member or friend (48%). Religion/spirituality might play a central role for a subset of patients across the cancer journey.

Development of a Patient-reported Experience and Outcome Measures in Pediatric Patients Undergoing Bowel Management for Constipation and Fecal Incontinence.

AIMS AND OBJECTIVES: The aim of this review is develop a reliable and valid questionnaire that assesses patient-reported experience measures (PREMs) and patient-reported outcome measures (PROMs) of caregivers, families, and patients with severe constipation and fecal incontinence who failed conservative treatments and require a formal bowel management program (BMP). METHODS: A 5-step iterative process was utilized to ensure the reliability and validity of the final instrument. Parents or guardians of patients undergoing our week-long BMP were first asked 20 open-ended questions aimed at understanding the challenges in managing their child's condition. Responses were transformed into an initial 41-item survey constituted of 2 constructs relating to PREMs (24 items) and PROMs (17 items). Survey items were then administered to 359 parents and guardians undergoing BMP. Cognitive interviews were performed with 20 families to assess face validity and to further refine the survey. Instrument readability and reliability was assessed by Flesch-Kincaid and Crohnbach α analyses. Items that weakly correlated were deleted to yield a final instrument that was both valid and reliable. RESULTS: A 33-statement survey was developed that encompasses important physical and emotional health concerns, quality of life, treatment success, financial considerations, schooling, parental employment, and social concerns. The final instrument, the Patient-Reported Experience and Outcome Measure in a Bowel Management Program (PREOM-BMP), is divided into 2 separate constructs that assess important patient-reported experience (22 items) and outcome (11 items) measures. Reliability analyses on the final instrument yielded a Crohnbach α of 0.925. CONCLUSIONS: The PREOM-BMP offers physicians and nursing professionals a brief and valid tool to measure the impact of a bowel management program on both the child and the family unit.

Recurrence of Pilonidal Disease: Our Best is Not Good Enough.

BACKGROUND: Recurrence rates of pilonidal disease have been reported to be high as 30%. Patients with recurrent pilonidal disease often develop chronic wounds and draining sinuses that incur long-term morbidity, disability, and decreased quality of life. The aim of this study was to characterize rates of recurrence in patients with pilonidal disease treated by pediatric surgeons. METHODS: A single center retrospective review of patients with pilonidal disease evaluated by pediatric surgeons from 2010 to 2015 was performed. Recurrence of pilonidal disease was defined as an episode of active pilonidal disease that required medical or surgical intervention >30 days from the preceding treatment. Repeated events proportional hazards regression modeling was performed to identify factors associated with time to recurrence. RESULTS: Among 307 patients treated for pilonidal disease, nearly 50% were male, and the median age at initial evaluation was 16 years (IQR 15-17). Approximately 45% were obese (BMI ≥ 95th percentile). The initial treatment during the study period was surgical excision in two-thirds and incision and drainage and/or antibiotics in one-third. The overall recurrence rate was 33%, with the majority of recurrences (80%) occurring within the first year. On multivariable analysis, obese BMI was the only factor independently associated with time to disease recurrence. CONCLUSIONS: Pilonidal disease has a substantial recurrence rate even after surgical excision. Future studies investigating treatments that can prevent disease recurrence are needed.

A Retrospective Study of Cervical Spine MRI Findings in Children with Abusive Head Trauma.

BACKGROUND/AIMS: Increasing attention has been given to the possible association of cervical spine (c-spine) injuries with abusive head trauma (AHT). The aims of this study were to describe c-spine MRI findings in hospitalized AHT patients. METHODS: This is a retrospective study of children under the age of 5 years with AHT admitted to hospital in 2004-2013. Those with c-spine MRI were identified, and the images were reviewed. RESULTS: 250 AHT cases were identified, with 34 (14%) undergoing c-spine MRI. Eleven patients (32%) had 25 findings, including hematoma in 2, occiput-C1-C2 edema in 3, prevertebral edema in 6, facet edema in 2, and interspinous and/or muscular edema in 10. No patients had a clinically evident c-spine injury, a clinically unstable c-spine, or required c-spine surgery. CONCLUSIONS: C-spine MRI may identify abnormalities not apparent upon physical examination and the procedure should therefore be considered in cases of suspected AHT.

The efficacy of initial hydrocortisone administration at preventing posttraumatic distress in adult trauma patients: a randomized trial.

UNLABELLED: OBJECTIVE/INTRODUCTION: Secondary pharmacological interventions have shown promise at reducing the development of posttraumatic stress disorder symptoms (PTSS) in preclinical studies. The present study examined the preliminary efficacy of a 10-day low-dose (20 mg bid) course of hydrocortisone at preventing PTSS in traumatic injury victims. METHODS: Sixty-four traumatic injury patients (34% female) were randomly assigned in a double-blind protocol to receive either a 10-day course of hydrocortisone or placebo initiated within 12 hours of the trauma. One-month and 3-months posttrauma participants completed an interview to assess PTSS and self-report measures of depression and health-related quality of life. RESULTS: Hydrocortisone recipients reported fewer PTSD and depression symptoms, and had greater improvements in health-related quality of life during the first 3 months posttrauma than did placebo recipients. Hydrocortisone recipients who had never received prior mental health treatment had the lowest PTSD scores. CONCLUSION: Low-dose hydrocortisone may be a promising approach to the prevention of PTSD in acutely injured trauma patients, and may be particularly efficacious in acutely injured trauma victims without a history of significant psychopathology.

Impact of multiple prenatal risk factors on newborn iron status at delivery.

BACKGROUND: Maternal anemia and several complications of pregnancy can affect fetal iron acquisition. AIM: Because it is unknown whether the effects of demographic and maternal risk factors (RF) are summative, we examined cord iron status in newborns with multiple RF for acquiring iron deficiency. METHODS: Cord blood indices from healthy control newborns with and without RF for newborn or infant iron deficiency were studied. RESULTS: Newborns with greater RF had poorer erythrocyte and storage iron status. Poorest status was seen if mothers with comorbid obesity and diabetes delivered large-for-gestation newborns. Findings highlight the importance of identifying RF.

Clinical response and pharmacokinetics from a phase 1 study of an active dosing schedule of flavopiridol in relapsed chronic lymphocytic leukemia.

We previously reported interim results of a phase 1 trial in patients with chronic lymphocytic leukemia (CLL) whereby flavopiridol was administered intravenously as a 30-minute bolus followed by 4-hour infusion. We now report full pharmacokinetic (PK) data, correlations of PK with clinical outcomes, and final response and progression-free survival (PFS). Twenty-one (40%) of 52 patients with relapsed CLL achieved a partial response (PR) with a median PFS of 12 months. Responders included 17 (40%) of 43 fludarabine refractory patients, 7 (39%) of 18 patients with del(17p13), and 14 (74%) of 19 patients with del(11q22). Six responders received repeat therapy at relapse, and 5 responded again with a second median PFS of 10 months. Noncompartmental analysis and nonlinear mixed effects modeling was used to estimate PK parameters and evaluate covariates. Two-compartment population parameter estimates were 31.4 L/h, 65.8 L, 8.49 L/h, and 157 L for CL, V1, Q, and V2, respectively. Flavopiridol area under the plasma concentration-time curve (AUC) correlated with clinical response and cytokine release syndrome, and glucuronide metabolite AUC correlated with tumor lysis syndrome. These composite results confirm high activity of this pharmacokinetically derived schedule in relapsed, genetically high-risk CLL. Furthermore, PK describes some, but not all, variability in response and toxicity.

Recruiting Latina families in a study of infant iron deficiency: a description of barriers, study adjustments and review of the literature.

BACKGROUND: Maternal minority status is a risk factor for iron deficiency in infancy and pregnancy. Because language and cultural differences may limit research participation, a prospective study examining iron deficiency included maternal minority status as an inclusionary criterion. Cognizant of potential barriers to recruitment, goals were to quantify eligible Latina enrollees and refusals, examine participation barriers, and devise possible solutions. METHODS: Mothers and their full-term newborns were eligible if the women were anemic, diabetic during pregnancy, of minority and/or lower socioeconomic status, and/or delivered an infant outside the average weight range for gestational age. Self-reported ethnicity and reasons for participation refusal were documented. RESULTS: During the first 18 months, 255 mothers and their infants were enrolled. Based on inclusionary criteria and the percentage of minority women admitted to the birthing center in a year, we anticipated 25% minority enrollees, with 16.3% Latina. Although 27% minority enrollment was obtained, only 8% were Latina (P < 0.01). System barriers, researcher perception barriers, and participant perception barriers were encountered. Over the next 8 months, addressing these recruitment barriers improved Latina enrollment. CONCLUSION: Enrollment barriers are significant hurdles to overcome, but with increased understanding and effort, more successful inclusion of Latina families can be achieved.

The essential nature of sharing in science.

Advances in science are the combined result of the efforts of a great many scientists, and in many cases, their willingness to share the products of their research. These products include data sets, both small and large, and unique research resources not commercially available, such as cell lines and software programs. The sharing of these resources enhances both the scope and the depth of research, while making more efficient use of time and money. However, sharing is not without costs, many of which are borne by the individual who develops the research resource. Sharing, for example, reduces the uniqueness of the resources available to a scientist, potentially influencing the originator's perceived productivity and ultimately his or her competitiveness for jobs, promotions, and grants. Nevertheless, for most researchers-particularly those using public funds-sharing is no longer optional but must be considered an obligation to science, the funding agency, and ultimately society at large. Most funding agencies, journals, and professional societies now require a researcher who has published work involving a unique resource to make that resource available to other investigators. Changes could be implemented to mitigate some of the costs. The creator of the resource could explore the possibility of collaborating with those who request it. In addition, institutions that employ and fund researchers could change their policies and practices to make sharing a more attractive and viable option. For example, when evaluating an individual's productivity, institutions could provide credit for the impact a researcher has had on their field through the provision of their unique resources to other investigators, regardless of whether that impact is reflected in the researcher's list of publications. In addition, increased funding for the development and maintenance of user-friendly public repositories for data and research resources would also help to reduce barriers to sharing by minimizing the time, effort, and funding needed by individual investigators to comply with requests for their unique resource. Indeed, sharing is an imperative, but it is also essential to find ways to protect for both the original owner of the resource and those wishing to share it.

Caregiver knowledge, opinion, and willingness to consent to trainee involvement in pediatric surgical care.

PURPOSE: Surgical training is shifting toward competency-based models that promote earlier supervised autonomy. We assessed caregiver knowledge, willingness to consent, and opinions regarding trainee autonomy in their child's operation. METHODS: At two academic children's hospitals, 100 caregivers of children aged 0-17 years completed an electronic survey in the pediatric surgery clinic (1/2018-4/2018). Knowledge, willingness to consent, and opinions of trainee involvement in their child's operation in standard and competency-based training models were assessed. McNemar's test compared willingness to consent with standard and competency-based training (p < 0.05). RESULTS: Caregivers were 75% female, 41% age 30-39 years old, and 78% white. All provider roles were correctly identified by 14% of caregivers. For routine procedures, caregivers would consent to a fellow assisting (95%) or independently operating with the attending present (78%). They would less likely consent if the attending was not in the operating room (39%) or the hospital (25%). Competency-based training improved willingness to consent, but was significant only for independence with the attending present. Most caregivers wanted to know about (81%) and be asked permission for (82%) trainee involvement in their child's operation. CONCLUSIONS: This study suggests that surgeons in academic settings must balance transparency with trainee autonomy when obtaining caregiver consent. LEVEL OF EVIDENCE: Level III.

Diagnostic Accuracy of Midline Pediatric Neck Masses.

OBJECTIVE: To assess clinical evaluation, ultrasound, and previously published predictive score at preoperatively diagnosing midline neck masses and demographic or clinical associations that aid in differentiation of thyroglossal duct and dermoid cysts. STUDY DESIGN: Retrospective chart review. SETTING: Tertiary care children's hospital. SUBJECTS: Patients <18 years undergoing primary midline neck mass surgery with histopathologic diagnosis of thyroglossal duct or dermoid cyst who had preoperative ultrasound performed were included. METHODS: An electronic medical record query generated 142 patients whose histopathologic diagnosis was thyroglossal duct cysts (TGDCs) or dermoid cysts (DCs). Charts were reviewed for demographic and clinical features. A radiologist blindly reviewed patients' ultrasounds for SIST (septae + irregular walls + solid components = thyroglossal) score components. Each patient received 3 preoperative diagnoses: clinical, ultrasound, and SIST. Statistical analyses were conducted to determine association of demographic, clinical, or radiographic variables with diagnoses. Specificity, sensitivity, and predictive values were evaluated for each candidate diagnosis. RESULTS: There were 83 TGDCs and 59 DCs. Tenderness, infection history, depth relative to strap muscles, and SIST components were more common among TGDCs. Sensitivity and positive and negative predictive values surpassed 63% for each diagnostic modality. SIST score outperformed other diagnostic modalities with sensitivity, positive predictive value, and negative predictive value of 84%, 91%, and 81%, respectively. Clinical and ultrasound assessments were largely inconclusive for dermoid cysts, but SIST correctly identified 89% of DCs. CONCLUSION: SIST score was the most accurate predictor of pediatric midline neck masses. Clinical and radiographic findings may help guide preoperative diagnosis, although further evaluation is required to develop more efficacious diagnostic tools.

Multi-institutional trial of non-operative management and surgery for uncomplicated appendicitis in children: Design and rationale.

Traditionally, children presenting with appendicitis are referred for urgent appendectomy. Recent improvements in the quality and availability of diagnostic imaging allow for better pre-operative characterization of appendicitis, including severity of inflammation; size of the appendix; and presence of extra-luminal inflammation, phlegmon, or abscess. These imaging advances, in conjunction with the availability of broad spectrum oral antibiotics, allow for the identification of a subset of patients with uncomplicated appendicitis that can be successfully treated with antibiotics alone. Recent studies demonstrated that antibiotics alone are a safe and efficacious treatment alternative for patents with uncomplicated appendicitis. The objective of this study is to perform a multi-institutional trial to examine the effectiveness of non-operative management of uncomplicated pediatric appendicitis across a group of large children's hospitals. A prospective patient choice design was chosen to compare non-operative management to surgery in order to assess effectiveness in a broad population representative of clinical practice in which non-operative management is offered as an alternative to surgery. The risks and benefits of each treatment are very different and a "successful" treatment depends on which risks and benefits are most important to each patient and his/her family. The patient-choice design allows for alignment of preferences with treatment. Patients meeting eligibility criteria are offered a choice of non-operative management or appendectomy. Primary outcomes include determining the success rate of non-operative management and comparing differences in disability days, and secondarily, complication rates, quality of life, and healthcare satisfaction, between patients choosing non-operative management and those choosing appendectomy.

Evaluation of the effect of pre-operative oral midazolam on post-operative oral fluid intake after tonsillectomy.

INTRODUCTION: The objective of this study was to determine if pre-operative oral midazolam administration decreased postoperative oral fluid intake after tonsillectomy with or without adenoidectomy. METHODS: A retrospective chart review identified 104 patients who were undergoing tonsillectomy with and without adenoidectomy who were not given midazolam preoperatively and 182 who were given midazolam preoperatively. Indications for tonsillectomy with or without adenoidectomy included obstructive sleep apnea, recurrent acute streptococcal pharyngotonsillitis, and, in selected cases, periodic fever with aphthous stomatitis, pharyngitis and adenopathy. All patients were evaluated in the pre-operative area by the attending anesthesiologist, who then determined whether or not he/she felt the patient would benefit from premedication with oral midazolam prior to surgery. Patients whom the attending anesthesiologist judged would benefit from midazolam were then given a 0.12-1.06 mg/kg dose (mean 0.35 mg/kg, STD 0.12), at the discretion of the anesthesiologist. Various methods were used to perform tonsillectomy, such as coblation and electrocautery, at the discretion of the otolaryngologist. Results were not stratified by surgical technique. Oral fluid intake was calculated by establishing the time of return to the floor from surgery and determining the documented oral fluid intake for the next 12 h. Oral fluid intake per kg per hour was then calculated. The amount of midazolam given was documented. RESULTS: There was no significant difference in oral fluid intake by group when adjusting for age and weight, F(1, 282) = 0.383, p = 0.537. Also, there was no significant difference in ml/kg/hr by group when adjusting for age and weight, F(1, 282) = 2.813, p = 0.095. CONCLUSIONS: There was no significant difference in oral fluid intake between the no midazolam and midazolam groups, indicating that clinicians can continue to use their judgement in administering midazolam to select anxious patients prior to tonsillectomy with or without adenoidectomy. Future work could include multi-center retrospective reviews or a randomized placebo-controlled trial to examine more carefully the effects of midazolam on postoperative oral fluid intake. LEVEL OF EVIDENCE: Level IV.

Laser hair depilation for the prevention of disease recurrence in adolescents and young adults with pilonidal disease: study protocol for a randomized controlled trial.

BACKGROUND: Laser hair depilation is a promising therapy in the management of pilonidal disease. However, the large controlled trials needed to demonstrate the effectiveness of this practice have not been performed. METHODS: We designed a single-center randomized controlled trial that will enroll 272 patients with pilonidal disease. Patients will be randomized to receive laser hair depilation of the sacrococcygeal region or the best recommended standard of care. The primary outcome is the rate of recurrent pilonidal disease at 1 year, defined as development of a new pilonidal abscess, folliculitis, or draining sinus after treatment, which would require antibiotic treatment, additional surgical incision and drainage, or excision within 1 year of enrollment. Secondary outcomes include each of the following at 1 year: disability days of the patient, disability days of the caregiver, health-related quality of life, healthcare satisfaction, disease-related attitudes and perceived stigma, pilonidal disease-related complications, pilonidal disease-related procedures, surgical excision, postoperative complications, and compliance with recommended treatment. DISCUSSION: This study will determine the effectiveness of laser hair depilation to reduce pilonidal disease recurrence in adolescents and young adults as compared to the best recommended standard of care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03276065 . Registered on 8 September 2017.

Laser Hair Depilation in the Treatment of Pilonidal Disease: A Systematic Review.

BACKGROUND: Laser hair depilation has shown promise in small series of patients with pilonidal sinus disease. The purpose of this study was to review the published literature on laser hair depilation in pilonidal disease to determine its effect on disease recurrence. METHODS: The PubMed, Embase, and Cochrane Central Register of Controlled Trials databases were searched to identify all studies published through December 1, 2017 that examined the role of laser hair depilation in the treatment of pilonidal sinus disease. Study characteristics, including design, treatment regimen, number of patients evaluated, rate of recurrence, and duration of follow up were recorded. RESULTS: Thirty-five published studies were included. Of these, 28 studies were retrospective and seven were prospective. There were five comparative studies: two retrospective, one prospective observational, and two randomized controlled trials. The number of patients included in each study ranged from one to 86 patients and patients received between one and 11 laser treatments. The pilonidal disease recurrence rate after laser depilation ranged from 0% to 28% at a mean follow-up ranging from 6 months to 5 years across studies. Four of the five studies that included a comparative group demonstrated a decreased recurrence rate compared to the non-laser cohort. CONCLUSION: Laser hair depilation is a promising therapy in the management of pilonidal disease. However, the literature published to date is heterogeneous and has limited generalizability. Additional research is needed to determine the effectiveness of laser hair depilation to prevent pilonidal disease recurrence.

Safety and Tolerability of Laser Hair Depilation in Pilonidal Disease: A Pilot Study.

BACKGROUND: Pilonidal disease is a common and painful disorder that can be challenging to manage. Recurrent surgical treatment is often warranted and may result in significant morbidity, with reported wound complication rates as high as 30%. Laser hair depilation of the natal cleft may decrease the incidence of recurrence. The purpose of this study was to assess the safety and tolerability of laser hair depilation in adolescents with pilonidal disease. METHODS: We performed a prospective, single arm, pilot trial of laser hair depilation to the natal cleft in 13 patients with pilonidal disease. Each patient received an outpatient laser depilation treatment every four weeks with a goal of five total treatments. Follow-up tolerability was measured after each treatment by obtaining Likert scale, patient-reported, pain scores immediately after laser treatment and every six hours post-treatment, for the first 24 hours. Consistent pain scores <4 were used as a proxy for tolerability. The primary end point was tolerability and safety, defined as pain scores consistently <4 and no deep second-degree burns during the 24-hour post-treatment period. The secondary end point was disease recurrence at one year. RESULTS: Thirteen patients were enrolled with 12 patients completing five laser depilation treatment sessions and one patient completing only four. There was 100% tolerability of treatments with no occurrence of second-degree burns. No patient was unable to complete a treatment session because of discomfort. Significantly diminished hair growth was noted after three treatments. All 13 patients were recurrence-free at a median follow-up of 13 months post-treatment initiation. CONCLUSIONS: Laser hair depilation is safe and well tolerated in adolescents with pilonidal disease and may be effective at decreasing pilonidal disease recurrence. A prospective randomized controlled trial is planned to determine effectiveness of laser hair depilation compared with chemical/mechanical depilation methods in preventing pilonidal disease recurrence.

Child Sexual Abuse Revictimization: Child Demographics, Familial Psychosocial Factors, and Sexual Abuse Case Characteristics.

INTRODUCTION: The purposes of this study were to describe child demographics, familial psychosocial factors, and sexual abuse case characteristics in children experiencing sexual abuse revictimization before the age of 18 years, and to compare them with children not identified as experiencing revictimization. METHOD: A retrospective chart review was conducted from both the revictimization group and the one-assessment group and reviewed for child sexual abuse case characteristics, familial psychosocial characteristics, and child demographic information. RESULTS: Children in the revictimization group were younger and more likely to possess a developmental delay and mental health diagnosis when compared with children in the one-assessment group. Higher proportions of parents in the one-assessment group were supportive and believed their child's sexual abuse allegation when compared with parents of the revictimization group. Families in the revictimization group were more likely to report multiple psychosocial risk factors when compared with the one-assessment group, including domestic violence, substance abuse concerns, mental health, parental history of sexual abuse, and financial concerns. DISCUSSION: This study suggests that children most at risk for sexual abuse revictimization often present with multiple familial psychosocial concerns and have parents/caregivers who are not supportive of them or their sexual abuse allegations.

Phase I study of low-dose suramin as a chemosensitizer in patients with advanced non-small cell lung cancer.

PURPOSE: Our preclinical studies have shown that acidic and basic fibroblastic growth factors confer broad spectrum chemoresistance and that low concentrations (10-50 microM) of suramin, a nonspecific fibroblastic growth factor inhibitor, enhance the antitumor activity of paclitaxel in vivo. The present Phase I study evaluated low-dose suramin in combination with paclitaxel/carboplatin in advanced non-small cell lung cancer patients. EXPERIMENTAL DESIGN: Patients received suramin followed by paclitaxel (175-200 mg/m(2)) and carboplatin area under the concentration-time curve of 6 mg/ml/min, every 3 weeks. The initial suramin dose for the first cycle was 240 mg/m(2), and the doses for subsequent cycles were calculated based on the 72-h pretreatment plasma concentrations. The recommended suramin dose would yield plasma concentrations of 10-20 microM at 48 h in >or=5 of 6 patients. RESULTS: Fifteen patients (11 stage IV, 4 stage IIIB, 9 chemonaive, and 6 previously treated) received 85 courses. The most common toxicities were neutropenia, nausea/vomiting, malaise/fatigue, and peripheral neuropathy. No treatment-related hospitalizations, adrenal dysfunction, or episodes of sepsis occurred. The initial suramin dose resulted in the targeted concentrations of 10-20 microM at 48 h in 5 of the first 6 patients treated but also resulted in peak concentrations > 50 microM in all patients. Dividing the suramin dose to be administered in two doses, 24 h apart, yielded the target concentrations and avoided undesirable peak concentrations. Discernable antitumor activity occurred in 7 of 10 patients with measurable disease, including 2 with prior chemotherapy. The median time to tumor progression is 8.5 months (range, 3-27+ months) for 12 evaluable patients. CONCLUSIONS: Low-dose suramin does not increase the toxicity of paclitaxel/carboplatin combination. The suramin dose can be calculated based on clinical parameters. Because of the preliminary antitumor activity observed, efficacy studies in chemonaive and chemorefractory patients are under way.

Combination immunotherapy of B-cell non-Hodgkin's lymphoma with rituximab and interleukin-2: a preclinical and phase I study.

PURPOSE: Cytokine-induced modulation of innate immunity is being explored to enhance the activity of monoclonal antibodies. Severe combined immunodeficient (SCID) mice engrafted with peripheral blood leukocytes (PBLs) from Epstein Barr virus-seropositive donors develop human B-cell non-Hodgkin's lymphomas [B-NHLs (hu-PBL-SCID mouse model)]. We used this hu-PBL-SCID mouse model to study the synergism between interleukin (IL)-2 and rituximab. We also conducted a phase I trial of IL-2 and rituximab in relapsed B-NHL to study whether expansion of natural killer (NK) cells and enhanced cellular cytotoxicity could be safely accomplished in vivo. EXPERIMENTAL DESIGN: Hu-PBL-SCID mice were treated with various schedules of rituximab and IL-2, with survival as the end point. Patients with relapsed B-NHL received rituximab (375 mg/m2 weekly x 4) followed by daily low-dose IL-2 (1 MIU/m2/day x 4 weeks) with pulses of intermediate-dose IL-2 (3-15 MIU/m2). Toxicity, NK cell numbers, and cellular cytotoxicity were measured. RESULTS: In the hu-PBL-SCID mouse, the combination of rituximab and IL-2 showed greater activity against B-NHL than either agent alone. Treatment was most effective when IL-2 was given before rituximab. Twelve patients with heavily pretreated B-NHL entered the phase I trial. Toxicity was manageable, and responses were observed. NK cell expansion and enhanced cellular cytotoxicity against a B-cell lymphoma target were observed but did not correlate with response. CONCLUSIONS: The combination of IL-2 and rituximab is synergistic against B-NHL in the hu-PBL-SCID model. In the phase I trial, a sequential combination of rituximab and IL-2 was well tolerated and achieved biological end points. Responses were observed.

Undergraduate Nursing Students' Experience of Service-Learning: A Phenomenological Study.

BACKGROUND: Service-learning programs are becoming more evident in baccalaureate nursing curriculums. Anecdotal evidence describing student perceptions has been written; however, research has not been conducted regarding the in-depth student experience of service-learning with vulnerable populations in inner cities. METHOD: This study was conducted using Colaizzi's descriptive phenomenological method of inquiry. Through purposeful sampling, 10 students were interviewed who have participated in service-learning throughout their sophomore, junior, and senior years of nursing education. RESULTS: Five themes were identified-Shattering Stereotypes, Overwhelmed With Their Need, Transitioning to Community Caregiver, Advocating, and Reciprocal Benefits-and a fundamental structure emerged. CONCLUSION: Listening to the voices of students participating in service-learning enables educators to gain an in-depth perspective of their experience and, ultimately, to maximize the service-learning program and improve care delivered to this vulnerable inner city population.