Composition of gut microbiota and its association with body mass index and lifestyle factors in a cohort of 7-18 years old children from the American Gut Project.

BACKGROUND: The association between the gut microbiota and obesity in young children and adolescents is not fully studied. OBJECTIVES: This study investigated the associations between the gut microbiota and body mass index (BMI) level (underweight, normal, overweight, obese) and lifestyles (diet type and exercise frequency), controlling for demographic and clinical factors among children aged 7-18 years. METHODS: A cohort study was conducted on 267 children aged 7-18 years from the American Gut Project. 16S rRNA sequences were analysed by QIIME 2™. Composition of gut microbiota and its associations with BMI level, weight change and lifestyles were analysed using linear decomposition model. RESULTS: Significant factors affecting the gut microbiota were BMI level (p = 0.009), exercise frequency (p = 0.003) and diet type (p = 0.01), controlling for age, sex and use of antibiotics and probiotics. More bacterial operational taxonomic units (OTUs) were associated with BMI level (120 OTUs) and diet type (122 OTUs) than exercise frequency (67 OTUs). Actinobacteria phylum had significantly depleted OTUs for BMI level, diet type and exercise frequency; Proteobacteria phylum had significantly enriched OTUs for higher BMI level and Firmicutes phylum had significantly enriched OTUs for more frequent exercise. CONCLUSIONS: Significant associations were found between the gut microbiota composition and BMI level and lifestyles controlling for demographic and clinical factors in children aged 7-18 years.

Impact of sildenafil on marital and sexual adjustment in patients and their wives after radiotherapy and short-term androgen suppression for prostate cancer: analysis of RTOG 0215.

PURPOSE: The Radiation Therapy Oncology Group (RTOG) 0215 investigated the efficacy of sildenafil in improving erectile dysfunction following radiotherapy and neoadjuvant/concurrent androgen deprivation therapy among prostate cancer patients and found a significant improvement on drug but only in 21% of study participants. This paper reports on a secondary aim to investigate the effect of sildenafil on overall sexual and marital adjustment among both patients and their wives. METHODS: RTOG 0215 was a placebo-controlled, double-blind, crossover trial of sildenafil. Participation of wives was optional. Twenty-four married heterosexual couples (33% of heterosexual couples in study) completed the Sexual Adjustment Questionnaire and Locke's Marital Adjustment Test. Treatment differences in mean change scores were evaluated by paired t-tests, and the proportion of patients achieving a clinically meaningful change was evaluated using chi-square tests. Spearman's correlation coefficients were used to determine the association of adjustment between patients and wives. RESULTS: There was no significant change in either sexual or marital adjustment for patients. For wives, there was a trend for improvement in sexual adjustment but no significant change in marital adjustment. Change in marital adjustment between patients and wives was weakly related (r(s) = 0.15, p = 0.48), and for sexual adjustment, there was a moderate, but nonsignificant relationship (r(s) = 0.40, p = 0.09). CONCLUSIONS: Larger studies are warranted to further examine possible differences in sexual experiences and treatment needs between prostate cancer patients and their wives, as well as to assess predictors of sildenafil response.

Patterns of missing mini mental status exam (MMSE) in radiation therapy oncology group (RTOG) brain cancer trials.

The Mini Mental Status Exam (MMSE) instrument has been commonly used in the Radiation Therapy Oncology Group (RTOG) to assess mental status in brain cancer patients. Evaluating patient factors in relation to patterns of incomplete MMSE assessments can provide insight into predictors of missingness and optimal MMSE collection schedules in brain cancer clinical trials. This study examined eight RTOG brain cancer trials with ten treatment arms and 1,957 eligible patients. Patient data compliance patterns were categorized as: (1) evaluated at all time points (Complete), (2) not evaluated from a given time point or any subsequent time points but evaluated at all the previous time points (Monotone drop-out), (3) not evaluated at any time point (All missing), and (4) all other patterns (Mixed). Patient characteristics and reasons for missingness were summarized and compared among the missing pattern groups. Baseline MMSE scores and change scores after radiation therapy (RT) were compared between these groups, adjusting for differences in other characteristics. There were significant differences in frequency of missing patterns by age, treatment type, education, and Zubrod performance status (ZPS; P < 0.001). Ninety-two percent of patients were evaluated at least once: seven percent of patients were complete pattern, 49% were Monotone pattern, and 36% were mixed pattern. Patients who received RT only regimens were evaluated at a higher rate than patients who received RT + other treatments (49-64% vs. 27-45%). Institutional error and request to not be contacted were the most frequent known reasons for missing data, but most often, reasons for missing MMSE was unspecified. Differences in baseline mean MMSE scores by missing pattern (Complete, Monotone dropout, Mixed) were statistically significant (P < 0.001) but differences were small (<1.5 points) and significance did not persist after adjustment for age, ZPS, and other factors related to missingness. Post-RT change scores did not differ significantly by missing pattern. While baseline and change scores did not differ widely by missing pattern for available measurements, incomplete data was common and of unknown reason, and has potential to substantially bias conclusions. Higher compliance rates may be achievable by addressing institutional compliance with assessment schedules and patient refusal issues, and further exploration of how educational and health status barriers influence compliance with MMSE and other tools used in modern neurocognitive batteries.

Measurement of vaginal length: Reliability of the vaginal sound--a Gynecologic Oncology Group study.

A decrease in vaginal length associated with treatments for gynecological malignancies, particularly pelvic radiotherapy, negatively impacts sexuality. Research into this important problem has been hampered by a lack of instrumentation to measure vaginal length. The Gynecologic Oncology Group recently evaluated the reliability of an instrument, the "vaginal sound," designed to measure vaginal length. Eighty-eight physicians and nurses attended a training session in the use of the vaginal sound that included a clinical practicum with live models. Reliability was assessed at the time of the practicum. The instrument performed well, with vaginal lengths in models without cancer in the upper range of normal as documented by Masters and Johnson. The vaginal sound also appeared to be sensitive to hypothesized changes in vaginal length. Interrater reliability was high with intraclass correlation coefficients of 0.88 among instructors and 0.76 among trainees. In conclusion, the vaginal sound is a simple, yet reproducible measure and adds methodologic rigor to studies of vaginal length.

Outcomes research in cancer clinical trial cooperative groups: the RTOG model.

BACKGROUND: The Radiation Therapy Oncology Group (RTOG), a National Cancer Institute sponsored cancer clinical trials research cooperative, has recently formed an Outcomes Committee to assess a comprehensive array of clinical trial endpoints and factors impacting the net effect of therapy. METHODS: To study outcomes in a consistent, comprehensive and coordinated manner, the RTOG Outcomes Committee developed a model to assess clinical, humanistic, and economic outcomes important in clinical trials. RESULTS: This paper reviews how the RTOG incorporates outcomes research into cancer clinical trials, and demonstrates utilization of the RTOG Outcomes Model to test hypotheses related to non-small-cell lung cancer (NSCLC). In this example, the clinical component of the model indicates that the addition of chemotherapy to radiotherapy (RT) improves survival but increases the risk of toxicity. The humanistic component indicates that esophagitis is the symptom impacting quality of life the greatest and may outweigh the benefits in elderly (> or =70 years) patients. The economic component of the model indicates that accounting for quality-adjusted survival, concurrent chemoRT for the treatment of NSCLC is within the range of economically acceptable recommendations. CONCLUSION: The RTOG Outcomes Model guides a comprehensive program of research that systematically measures a triad of endpoints considered important to clinical trials research.

The identification and screening of men at high risk for developing prostate cancer.

It is estimated that the lifetime risk of being diagnosed with prostate cancer is 1 in 5. The identification of risk factors, including age, African-American ancestry, family history, and possibly diet and environmental factors, has allowed health care professionals the opportunity to identify, screen, and study men at the greatest risk of developing prostate cancer. The risk factors, current screening tools, and the informed consent process for men participating in a prostate cancer screening program are outlined.

Assessing women's sexuality after cancer therapy: checking assumptions with the focus group technique.

Cancer and cancer therapies impair sexual health in a multitude of ways. The promotion of sexual health is therefore vital for preserving quality of life and is an integral part of total or holistic cancer management. Nursing, to provide holistic care, requires research that is meaningful to patients as well as the profession to develop educational and interventional studies to promote sexual health and coping. To obtain meaningful research data instruments that are reliable, valid, and pertinent to patients' needs are required. Several sexual functioning instruments were reviewed for this study and found to be lacking in either a conceptual foundation or psychometric validation. Without a defined conceptual framework, authors of the instruments must have made certain assumptions regarding what women undergoing cancer therapy experience and what they perceive as important. To check these assumptions before assessing women's sexuality after cancer therapies in a larger study, a pilot study was designed to compare what women experience and perceive as important regarding their sexuality with what is assessed in several currently available research instruments, using the focus group technique. Based on the focus group findings, current sexual functioning questionnaires may be lacking in pertinent areas of concern for women treated for breast or gynecologic malignancies. Better conceptual foundations may help future questionnaire design. Self-regulation theory may provide an acceptable conceptual framework from which to develop a sexual functioning questionnaire.

Prostate cancer risk assessment program. A model for the early detection of prostate cancer.

Prostate cancer is the most common form of cancer (except skin cancer) in men. Several factors have been associated with an increased risk for prostate cancer, including age, ethnicity, family history, lifestyle, and environmental exposures. Recognition of the importance of the interaction of these factors in prostate cancer has led to an interest in their evaluation as a model both for studying genetic susceptibility patterns and for studying and providing educational tools and preventive interventions. One such model has been developed at Fox Chase Cancer Center. Critical to the implementation of the model has been the establishment of the Prostate Cancer Risk Registry (PCRR) and Prostate Cancer Risk Assessment Program (PRAP). Together, they serve as a unique resource for investigating the interaction between environmental factors and genetic susceptibility patterns; exploring the early, premalignant biological markers of prostate cancer; and prospectively assessing the quality of life (QOL) of men at risk. In addition, PRAP facilitates the evaluation of models for prostate cancer risk counseling and screening in the community. This paper describes this model for early detection and risk reduction, along with preliminary data from its first two study aims. The program is particularly relevant in view of the wealth of genetic information emerging from the Human Genome Project.

Cost-effectiveness and palliative care.

OBJECTIVES: To examine the issues and methods in measuring the cost-effectiveness of palliative care for incurable cancer. DATA SOURCES: Review articles, book chapters, and research studies pertaining to cost-effectiveness and palliative care. CONCLUSIONS: All health care interventions, whether palliative or active therapy, are delivered at a price. Assessing the cost-effectiveness of interventions does not mean that less is better; it means that whatever is spent maximizes the utility of resource allocation. IMPLICATIONS FOR NURSING PRACTICE: Nurses influence both the cost and the effectiveness of palliative care. Cost of nursing services is often factored into the numerator of the cost-effective equation. Effectiveness of nursing care should be factored into the denominator and can be measured in multiple ways, including the impact on patients' quality of life. Nurses can play an active role in assessing and advocating for the cost-effectiveness of palliative interventions.

The managed care contract: implementation in radiation oncology.

PURPOSE/OBJECTIVES: To explore the risks and benefits, for patients and the department, of managed care capitation in radiation oncology and to discuss nurses' roles in participating in a managed care contract. DATA SOURCES: Published articles, American Nurse Association and American College of Radiology publications, newspaper articles, newsletters, and oral presentations. DATA SYNTHESIS: As of June 1, 1992, Fox Chase Cancer Center entered into an agreement for radiation oncology service with U.S. Healthcare. This attempt to capitate oncology services was one of the first made by a managed care network. Consumers and care providers may experience advantages and disadvantages as a result of capitation. Nurses can maximize the advantages for patients and institutions by becoming familiar with managed care. CONCLUSION: Nurses no longer can care for patients without recognizing the political and market forces that influence their ability to deliver care. Familiarity with managed care is a mandatory requirement for all nurses at the staff and management levels. IMPLICATIONS FOR NURSING PRACTICE: Nurses' role in the contractual arrangement of managed care include educator, coordinator, negotiator, and patient advocate. Nurses need to be acutely aware of today's managed care climate and its effect on the amount, cost, quality, and location of patient services provided.

The impact on quality of life by radiation late effects.

The Radiation Therapy Oncology Group (RTOG) is developing an improved scoring system for the late effects of radiation therapy. There is a need to assess the impact of treatment on long-term survival. The RTOG Late Effects Toxicity Grading Scale documents the absence or the degree to which a symptom or sign is present. The scale in itself does not, however, score the impact of symptoms on survival. This Late Effects Scale in conjunction with quality-of-life assessments will provide the information necessary to assess the impact of treatment toxicities on normal daily living. Neither documentation of late effects nor their impact on quality of survival is an end in itself. These scales are only instruments that should serve to direct us toward our higher goal of designing interventional studies concerned with the quality of survival or rehabilitation. The development of the Late Effects Toxicities Grading Scale is a beginning.

Radiation Therapy Oncology Group quality of life assessment: design, analysis, and data management issues.

The Radiation Therapy Oncology Group (RTOG) has embarked on seven phase II or phase III multicentre clinical trials involving a quality of life component. Each quality of life trial used questionnaires or examinations that have been tested for reliability and validity by independent investigators. Each trial includes questionnaires that examine the patient's physical, functional, social, and emotional status, and that measure a specific quality of life issue pertinent to the patient's diagnosis or treatment. Two trial designs have been implemented for studies with quality of life endpoints. One design involves companion trials to the primary treatment study pertaining solely to the quality of life endpoint. The second design integrates the quality of life component into the primary trial design. The RTOG has found a need for education of individuals and institutions expected to administer and obtain the quality of life data. Once the data have been collected several methods for the analysis of the quality of life data are available. However, there is no one best method for analysing quality of life data, thus more than one method should be used in order to provide insight into the data.

Vaginal stenosis and sexual function following intracavitary radiation for the treatment of cervical and endometrial carcinoma.

PURPOSE: This study was designed to document the incidence and degree of vaginal stenosis, sexual activity, and satisfaction in women treated with intracavitary radiation therapy for cervical or endometrial carcinoma. METHODS AND MATERIALS: The incidence of vaginal stenosis in 90 patients treated for either cervical carcinoma (n = 42) or endometrial carcinoma (n = 48) with standard doses of intracavitary radiation from 1989 to 1992 with at least 6 months follow-up was recorded. Vaginal length was measured using a modified vaginal dilator calibrated in centimeters. Semistructured patient interviews documented pretreatment and posttreatment sexual activity and sexual satisfaction. RESULTS: Vaginal length was found to be dependent on diagnosis (cervical vs. endometrial), stage (I vs. II/III), and follow-up interval (6-12 months, 12-24 months, and > 24 months). Slightly more women reported sexual activity post vs. pretreatment (31% active pretreatment vs. 43% active posttreatment). However, 22% of women reported a decrease in sexual frequency and 37% reported a decrease in sexual satisfaction. Reports for all parameters were worse for women treated for cervical carcinoma vs. women treated for endometrial carcinoma with the exception of dyspareunia. CONCLUSION: High-dose radiation for either cervical or endometrial carcinoma at standard doses with or without hysterectomy can cause a decrease in vaginal length as compared to the normal vaginal length of 8 to 9 cm documented by Masters and Johnson. Women treated with intracavitary implants remained as sexually active postimplant as preimplant, however, coital frequency and sexual satisfaction decreased while dyspareunia increased. The decrease in vaginal length may explain in part the decrease in sexual satisfaction but cause and effect have not been established.

Radiation oncology nurses: staffing patterns and role development.

A national survey that recently was conducted by the Oncology Nursing Society (ONS) shows an alarmingly low level of budgeted staff nurse positions in radiation oncology departments. This report, coupled with persistent comments from radiation oncology nurses nationwide who say that they often are expected to spend more time on "clinic care" than on patient care, raises grave concerns for patients. Patients receiving radiation therapy must deal with the actual and potential side effects of therapy as well as the anxiety caused by therapy and the cancer diagnosis. Managing symptoms and assisting patients with coping are just two of the many patient-care functions that nurses perform, yet role ambiguity may be the major reason for the low number of budgeted staff nurse positions reported in the ONS survey. This article describes two recent publications that offer definitive role development and staffing pattern guidelines for radiation oncology nurses. These guidelines may help to elicit support from the hospital administration to budget for adequate staff and to use that staff appropriately.

Model quality assurance program for radiation oncology nursing.

The first step in developing a quality assurance program for radiation oncology nursing is to define the services the nurse should provide to the patient receiving radiation therapy. The focus of radiation oncology nurses should be quality of life issues provided through their roles as teachers, direct care givers, and counselors. With this focus in mind, a three-phase plan was developed at Fox Chase Cancer Center to operationalize a quality assurance program for radiation oncology nursing based on Guidelines for cancer nursing practice by the Oncology Nursing Society (ONS) and the American Nurses' Association (ANA).