Patient-reported outcomes before treatment for localized prostate cancer: are there differences among countries? Data from the True North Global Registry.

INTRODUCTION: Similar Patient-Reported Outcomes (PROs) at diagnosis for localized prostate cancer among countries may indicate that different treatments are recommended to the same profile of patients, regardless the context characteristics (health systems, medical schools, culture, preferences…). The aim of this study was to assess such comparison. METHODS: We analyzed the EPIC-26 results before the primary treatment of men diagnosed of localized prostate cancer from January 2017 onwards (revised data available up to September 2019), from a multicenter prospective international cohort including seven regions: Australia/New Zealand, Canada, Central Europe (Austria / Czech Republic / Germany), United Kingdom, Italy, Spain, and the United States. The EPIC-26 domain scores and pattern of three selected items were compared across regions (with Central Europe as reference). All comparisons were made stratifying by treatment: radical prostatectomy, external radiotherapy, brachytherapy, and active surveillance. RESULTS: The sample included a total of 13,483 men with clinically localized or locally advanced prostate cancer. PROs showed different domain patterns before treatment across countries. The sexual domain was the most impaired, and the one with the highest dispersion within countries and with the greatest medians' differences across countries. The urinary incontinence domain, together with the bowel and hormonal domains, presented the highest scores (better outcomes) for all treatment groups, and homogeneity across regions. CONCLUSIONS: Patients with localized or locally advanced prostate cancer undergoing radical prostatectomy, EBRT, brachytherapy, or active surveillance presented mainly negligible or small differences in the EPIC-26 domains before treatment across countries. The results on urinary incontinence or bowel domains, in which almost all patients presented the best possible score, may downplay the baseline data role for evaluating treatments' effects. However, the heterogeneity within countries and the magnitude of the differences found across countries in other domains, especially sexual, support the need of implementing the PRO measurement from diagnosis.

Methamphetamine Users Have Increased Dental Disease: A Propensity Score Analysis.

Methamphetamine (MA) users are assumed to have a high burden of tooth decay. Less clear is how the distribution and severity of dental caries in MA users differ from the general population. Using a covariate-balancing propensity score strategy, we investigated the differential effects of MA use on dental caries by comparing the patterns of decayed, missing, and filled teeth in a community sample of 571 MA users with a subset of 2,755 demographically similar control individuals selected from a National Health and Nutrition Examination Survey (NHANES) cohort. Recruited over a 2-y period with a stratified sampling protocol, the MA users underwent comprehensive dental examinations by 3 trained and calibrated dentists using NHANES protocols. Propensity scores were estimated with logistic regression based on background characteristics, and a subset of closely matched subjects was stratified into quintiles for comparisons. MA users were twice as likely to have untreated caries (odds ratio [OR] = 2.08; 95% confidence interval [95% CI]: 1.55 to 2.78) and 4 times more likely to have caries experience (OR = 4.06; 95% CI: 2.24 to 7.34) than the control group of NHANES participants. Additionally, MA users were twice as likely to have 2 more decayed, missing, or filled teeth (OR = 2.08; 95% CI: 1.29 to 2.79) than the NHANES participants. The differential involvement of the teeth surfaces in MA users was quite distinctive, with carious surface involvement being highest for the maxillary central incisors, followed by maxillary posterior premolars and molars. Users injecting MA had significantly higher rates of tooth decay compared with noninjectors (P = 0.04). Although MA users experienced decayed and missing dental surfaces more frequently than NHANES participants, NHANES participants had more restored surfaces, especially on molars. The high rates and distinctive patterns of dental caries observed could be used 1) to alert dentists to covert MA use in their patients and 2) as the basis for comprehensive management strategies.

Impact of the BEA zeolite morphology on isobutane adsorption followed by Reversed-Flow Inverse Gas Chromatography.

The mass transfer phenomena of isobutane (i-C4) were investigated at 343K on three protonic BEA zeolites. Defined by their crystallites sizes and degrees of aggregation, these samples were characterized by Reversed-Flow Inverse Gas Chromatography (RF-GC). This simple technique, used in conjunction with numerical computation, allowed the determination of physicochemical quantities like local monolayer capacities, probability density functions and diffusion coefficients in a time-resolved way. This study enabled to conclude that the effective diffusion coefficient was affected by the size of the zeolite agglomerate whereas the surface diffusion depended on the zeolite crystallite size.

Do malpractice concerns, payment mechanisms, and attitudes influence test-ordering decisions?

Greater understanding is needed of nonclinical factors that determine neurologists' decisions to order tests. The authors surveyed 595 US neurologists and utilized demographic information, attitude scales, and clinical scenarios to evaluate the influence of nonclinical factors on test-ordering decisions. Greater test reliance, higher malpractice concerns, and receiving reimbursement for testing were all associated with a higher likelihood of test ordering. These findings have implications for training needs and suggest malpractice worries may inflate health care costs.

Clinician variability in characterizing mandible fractures.

PURPOSE: This study evaluated variability in the clinical parameters commonly used to characterize mandible fractures. PATIENTS AND METHODS: Inter-rater reliability of 18 oral and maxillofacial surgeons was assessed using radiographs of 22 cases of mandible fractures. Raters were asked to evaluate each case based on several parameters including number, location, and displacement of the individual fractures and severity of the composite injury. To evaluate intra-rater reliability, selected cases were reviewed at a second session by a subgroup of these surgeons. Tests of concordance used to quantify measurement reliability included the interclass correlation coefficient and multiple-rater kappa statistics. RESULTS: Inter-rater agreement on the number of constituent fractures ranged from excellent for simpler fractures to poor for complex gunshot injuries. Even within raters, the range of interclass correlation for complex injuries was only 0.33 to 0.42 between the 2 assessments. Clinicians appeared to be better at delineating coronoid, condyle, ramus, and angle fractures; symphyseal and canine region fractures had lower inter- and intrarater agreement. Tests of concordance showed moderate to excellent reliability when fracture displacements were expressed in millimeters, but only fair reliability when displacements were expressed as categories. Even when the clinicians concurred on displacement measurements, a large overlap was observed in their categorization of these displacements. Despite the differences in the assessment of individual parameters, the high intrarater reliability coefficient (0.78) indicated that the individual clinicians had a high internal consistency in their assignment of summary severity scores. Multiple regression analysis revealed the number of constituent fractures, the type of fracture, and amount of fracture displacement (millimeters) to be significant predictors of clinician ratings of injury severity. CONCLUSIONS: The clinician variability underscores the difficulties involved in trauma description and scoring. The study identifies some sources of clinician variability and emphasizes the need to standardize the characterization of mandible fractures by using explicit guidelines.

Decreased anterior cingulate myo-inositol/creatine spectroscopy resonance with lithium treatment in children with bipolar disorder.

This project was designed to compare differences in brain proton spectra between children and adolescents with bipolar disorder (BPD) and gender and age-matched normal controls, and to measure changes in myo-inositol levels following lithium therapy, utilizing in vivo proton magnetic resonance spectroscopy (1H MRS). A single voxel (2x2x2 cm3) was placed in brain anterior cingulate cortex for acquisition of the 1H spectra at baseline and after acute (7 days) lithium administration in 11 children (mean age 11.4 years) diagnosed with BPD, and in 11 normal controls. Acute lithium treatment was associated with a significant reduction in the myo-inositol/creatine ratio. This decrement was also significant in lithium-responders when analyzed separate from non-responders. Compared to normal controls, BPD subjects showed a trend towards a higher myo-inositol/creatine during the manic phase. These preliminary data provide evidence that a significant reduction in anterior cingulate myo-inositol magnetic resonance may occur after lithium treatment, especially among responders. Follow-up studies involving a larger sample may allow us to confirm whether changes in myo-inositol associated with acute lithium therapy persist in long-term clinical response of patients with and without lithium compliance.

Management of multiple sclerosis across managed care and fee-for-service systems.

OBJECTIVE: To measure and compare care for adults with MS across managed care and fee-for-service (FFS) health systems. METHODS: The authors sampled adults with MS having physician visits over a 2-year period from a group model health maintenance organization (HMO) in southern California, from a midwestern independent practice association (IPA) model managed care plan, and from the FFS portion of the practices of a random sample of southern California neurologists. The authors mailed surveys to subjects in mid-1996; 930 of 1,164 (80%) of those eligible responded. The authors measured sociodemographic and clinical characteristics, management of recent changes in mobility, bladder control, and fatigue, use of a disease-modifying agent, assessment of general health symptoms and issues, and unmet information needs. The authors adjusted comparisons between systems for comorbidity, disease severity, and disease type. RESULTS: The groups differed on most sociodemographic and clinical characteristics. There were few differences in symptom management; differences that did exist tended toward more referrals or treatment for the FFS group. Access to the disease-modifying agent available at the time of the survey did not differ across systems, although patients' perceptions of the rationale for not using the drug did vary. General health issues and symptoms were more often assessed in the FFS and IPA systems than in the HMO, but improvement was needed across all three systems of care. There were substantial unmet information needs in all groups and especially high ones in the FFS and HMO samples. CONCLUSIONS: Strategies to improve care for people with MS should be developed and evaluated, particularly in areas like symptom assessment and meeting patient information needs. Where variations in service delivery exist, longitudinal studies are also needed to evaluate the potential impact on outcomes and to evaluate reasons for variation.

Improving follow-up after an abnormal pap smear: results from a quasi-experimental intervention study.

The success of cervical cancer control programs depends on regular screening with the Pap smear test and prompt and appropriate treatment of early neoplastic lesions. Recognizing the potentially grave consequences of lack of follow-up for abnormal Pap smears, numerous intervention studies have tested the impact of a variety of strategies to increase return for follow-up. The majority of these studies were evaluated under controlled experimental conditions. Despite the encouraging findings of these trials, the next step in the research continuum requires that the effectiveness of these interventions be demonstrated in real world settings before full implementation is initiated. We report the results of an evaluation study assessing the combined effectiveness of three intervention modalities found effective in prior randomized studies: a tracking follow-up protocol, transportation incentives, and financial incentives. This study used a before-after, nonequivalent control group design to assess the impact of a multifaceted intervention that included a computerized tracking protocol with transportation and financial incentives. The study was implemented at two major hospitals, two comprehensive health centers (CHC), and nine public health centers (PHC) under the jurisdiction of the Los Angeles County Department of Health Services. One hospital, one CHC, and the four PHC located in the catchment area of the CHC were selected as experimental sites. The control sites - one hospital, one CHC, and five PHC - provided usual care. All women with an abnormal Pap smear at the intervention and control sites were included in the study. The study consisted of a 1-year period of baseline data collection (September 1989-August 1990), followed by a 2(1/2)-year intervention period (September 1990-February 1993). During the intervention period, the intervention protocol was implemented at the experimental sites, and the control sites provided usual care. Overall, we found that the rates of receipt of follow-up care were consistent with those found in similar studies. In contrast to results obtained in these prior randomized trials, we did not find strong and consistent evidence for intervention effects. Significant findings emerged only at the CHC and hospital levels and only for selected years. Results underscore the importance of testing interventions in real world conditions before large-scale implementation is initiated. In addition, this study highlights the challenge of detecting intervention effects in large-scale studies because of the greater measurement difficulties in field studies as compared with controlled experiments.

Role of breast reconstructive surgery in physical and emotional outcomes among breast cancer survivors.

BACKGROUND: Tissue-sparing approaches to primary treatment and reconstructive options provide improved cosmetic outcomes for women with breast cancer. Earlier research has suggested that conservation or restitution of the breast might mitigate the negative effects of breast cancer on women's sexual well-being. Few studies, however, have compared psychosocial outcomes of women who underwent lumpectomy, mastectomy alone, or mastectomy with reconstruction. To address some of these issues, we examined women's adaptation to surgery in two large cohorts of breast cancer survivors. METHODS: A total of 1957 breast cancer survivors (1-5 years after diagnosis) from two major metropolitan areas were assessed in two waves with the use of a self-report questionnaire that included a number of standardized measures of health-related quality of life, body image, and physical and sexual functioning. All P: values are two-sided. RESULTS: More than one half (57%) of the women underwent lumpectomy, 26% had mastectomy alone, and 17% had mastectomy with reconstruction. As in earlier studies, women in the mastectomy with reconstruction group were younger than those in the lumpectomy or mastectomy-alone groups (mean ages = 50.3, 55.9, and 58.9, respectively; P: =.0001); they were also more likely to have a partner and to be college educated, affluent, and white. Women in both mastectomy groups complained of more physical symptoms related to their surgeries than women in the lumpectomy group. However, the groups did not differ in emotional, social, or role function. Of interest, women in the mastectomy with reconstruction group were most likely to report that breast cancer had had a negative impact on their sex lives (45.4% versus 29.8% for lumpectomy and 41.3% for mastectomy alone; P: =. 0001). CONCLUSIONS: The psychosocial impact of type of primary surgery for breast cancer occurs largely in areas of body image and feelings of attractiveness, with women receiving lumpectomy experiencing the most positive outcome. Beyond the first year after diagnosis, a woman's quality of life is more likely influenced by her age or exposure to adjuvant therapy than by her breast surgery.

Care for depression in HMO patients aged 65 and older.

OBJECTIVE: To examine treatment for depression among older adults in a large staff model health maintenance organization (HMO). DESIGN: A 4-year prospective cohort study (1989-1993). SETTING: Four primary care clinics of a large staff model HMO in Seattle, Washington. PATIENTS: A total of 2558 Medicare enrollees aged 65 and older. MAIN OUTCOME MEASURES: Treatment of depression was defined as primary care visits resulting in depression diagnoses, use of antidepressant medications, or specialty mental health services. MAIN RESULTS: The older adults in our sample had low rates of treatment for depression, ranging from 4 to 7% in the entire sample and from 12 to 25% among those with probable depressive disorders. Predictors of treatment included female gender, severity, and persistence of depressive symptoms, and severity of comorbid medical illness. Even when patients were treated for depression, the intensity of treatment was very low. Overall likelihood of treatment for depression increased somewhat from 1989 to 1993, but among those treated, the rate of adequate antidepressant use remained below 30%. CONCLUSIONS: There is still considerable need to improve care for older adults with depression in primary care.

Help-seeking steps and service use for children in foster care.

This study describes help-seeking steps and service-use patterns for school-age children in foster care. It also examines how these access indices are moderated by sociodemographic, enabling, and child disorder factors. Two home interviews and a telephone teacher interview were conducted using a sample of 302 randomly selected children (age 6-12 years) in foster care. The majority of children (80%) were given a psychiatric diagnosis, and 43% of the foster parents perceived a need for mental health services for the child. In the past year, about one-half of the children had received mental health (51%) and special education services (52%). Age and ethnicity, foster parent education, placement history, level of monthly benefits, number of caseworker visits, and disorder characteristics were related to help-seeking steps and mental health service use. Strategies to improve access to mental health services for children in foster care should include interventions at the caregiver and system levels.

Managing menopausal symptoms in breast cancer survivors: results of a randomized controlled trial.

BACKGROUND: Menopausal symptoms (e.g., hot flashes, vaginal dryness, and stress urinary incontinence) are very common in breast cancer survivors and cannot be managed with standard estrogen replacement therapy (ERT) in these patients. The purpose of this study was to test the efficacy of a comprehensive menopausal assessment (CMA) intervention program in achieving relief of symptoms, the improvement in quality of life (QOL), and sexual functioning in breast cancer survivors. METHODS: Using a two-group, randomized controlled design, we assigned 76 postmenopausal breast cancer survivors with at least one severe target symptom either to the intervention group or to a usual-care group. Seventy-two women were evaluable at the end of the study period. The CMA intervention, delivered by a nurse practitioner, focused on symptom assessment, education, counseling and, as appropriate, specific pharmacologic and behavioral interventions for each of the three target symptoms. Psychosocial symptoms were assessed with the use of a self-report screening instrument, and distressed women were referred for counseling if needed. The intervention took place over a 4-month period. Outcomes measured were scores on a composite menopausal symptom scale, the RAND Short Form Health Survey Vitality Scale, and the Cancer Rehabilitation Evaluation System (CARES) Sexual Functioning Scale at baseline and at 4-month follow-up. All statistical tests were two-sided and were performed at the alpha =. 05 significance level. RESULTS: Patients receiving the intervention demonstrated statistically significant improvement (P =.0004) in menopausal symptoms but no significant change in vitality (P =.77). Sexual functioning was statistically significantly improved (P =.04) in the treatment group compared with the usual-care group. CONCLUSIONS: A clinical assessment and intervention program for menopausal symptom management in breast cancer survivors is feasible and acceptable to patients, leading to reduction in symptoms and improvement in sexual functioning. Measurable improvement in a general QOL measure was not demonstrated.

Fatigue in breast cancer survivors: occurrence, correlates, and impact on quality of life.

PURPOSE: To describe the occurrence of fatigue in a large sample of breast cancer survivors relative to general population norms and to identify demographic, medical, and psychosocial characteristics of fatigued survivors. PATIENTS AND METHODS: Breast cancer survivors in two large metropolitan areas completed standardized questionnaires as part of a survey study, including the RAND 36-item Health Survey, Center for Epidemiological Studies-Depression Scale, Breast Cancer Prevention Trial Symptom Checklist, Medical Outcomes Study Sleep Scale, and demographic and treatment-related measures. RESULTS: On average, the level of fatigue reported by the breast cancer survivors surveyed (N = 1,957) was comparable to that of age-matched women in the general population, although the breast cancer survivors were somewhat more fatigued than a more demographically similar reference group. Approximately one third of the breast cancer survivors assessed reported more severe fatigue, which was associated with significantly higher levels of depression, pain, and sleep disturbance. In addition, fatigued women were more bothered by menopausal symptoms and were somewhat more likely to have received chemotherapy (with or without radiation therapy) than nonfatigued women. In multivariate analyses, depression and pain emerged as the strongest predictors of fatigue. CONCLUSION: Although the majority of breast cancer survivors in this large and diverse sample did not experience heightened levels of fatigue relative to women in the general population, there was a subgroup of survivors who did report more severe and persistent fatigue. We identified characteristics of these women that may be helpful in elucidating the mechanisms underlying fatigue in this population, as well as directing intervention efforts.

Routine outcome monitoring in a public mental health system: the impact of patients who leave care.

OBJECTIVE: An interest exists in using patient outcome data to evaluate the performance of publicly financed mental health organizations. Because patients leave these organizations at a high rate, the impact of patient attrition on routinely collected outcome data was examined. METHODS: In one county mental health system, routinely collected data on a wide range of outcomes were examined, and a random sample of patients who left treatment was interviewed. RESULTS: Of the 1,769 patients in ongoing treatment during a one-year period, 554 (31 percent) were lost to follow-up. Among a random sample of 102 patients who left treatment, two had died and 47 were interviewed. Compared with patients who left treatment, patients who stayed were older, more likely to have schizophrenia, less likely to be married, more likely to be living in an institution, more satisfied with their relationships with friends and family, and less likely to have legal problems. Average outcomes improved both for patients who stayed and for patients who left. Patients who left and could be located for follow-up were less severely ill and showed the greatest improvement and the best outcomes. Patients who left and could not be located may have been more severely ill at baseline. CONCLUSIONS: Outcomes appear to vary substantially by whether patients stay in care and whether they can be located after leaving care. Public mental health systems that wish to evaluate treatment quality using outcome data should attend carefully to which patients are being assessed. Biases can result from convenience sampling and from patients leaving care.

The 18-month impact of an emergency room intervention for adolescent female suicide attempters.

Following a suicide attempt by female adolescents, the impact of a specialized emergency room (ER) care intervention was evaluated over the subsequent 18 months. Using a quasi-experimental design, this study assigned 140 female adolescent suicide attempters (SA), ages 12-18 years, and their mothers (88% Hispanic) to receive during their ER visit either: (a) specialized ER care aimed at enhancing adherence to outpatient therapy by providing a soap opera video regarding suicidality, a family therapy session, and staff training; or (b) standard ER care. The adjustment of the SA and their mothers was evaluated over 18 months (follow-up, 92%) using linear mixed model regression analyses. SA's adjustment improved over time on most mental health indices. Rates of suicide reattempts (12.4%) and suicidal reideation (29.8%) were lower than anticipated and similar across ER conditions. The specialized ER care condition was associated with significantly lower depression scores by the SA and lower maternal ratings on family cohesion. Significant interactions of intervention condition with the SA's initial level of psychiatric symptomatology indicated that the intervention's impact was greatest on maternal emotional distress and family cohesion among SA who were highly symptomatic. SA's attendance at therapy sessions following the ER visit was significantly associated with only one outcome--family adaptability. Specialized ER interventions may have substantial and sustained impact over time, particularly for the parents of youth with high psychiatric symptomatology.

Multiple imputation and posterior simulation for multivariate missing data in longitudinal studies.

This paper outlines a multiple imputation method for handling missing data in designed longitudinal studies. A random coefficients model is developed to accommodate incomplete multivariate continuous longitudinal data. Multivariate repeated measures are jointly modeled; specifically, an i.i.d. normal model is assumed for time-independent variables and a hierarchical random coefficients model is assumed for time-dependent variables in a regression model conditional on the time-independent variables and time, with heterogeneous error variances across variables and time points. Gibbs sampling is used to draw model parameters and for imputations of missing observations. An application to data from a study of startle reactions illustrates the model. A simulation study compares the multiple imputation procedure to the weighting approach of Robins, Rotnitzky, and Zhao (1995, Journal of the American Statistical Association 90, 106-121) that can be used to address similar data structures.

Predictors of sexual health in women after a breast cancer diagnosis.

PURPOSE: To identify variables that might be predictive of sexual health (interest, dysfunction, and satisfaction) in a large sample of breast cancer survivors, with a validation conducted in a second, independent sample. PATIENTS AND METHODS: On the basis of a conceptual framework of sexual health in breast cancer survivors, we performed multivariable regression analyses to estimate sexual interest, dysfunction, and satisfaction in both samples. Additional analyses were performed using stepwise regression and recursive partitioning to explore in each sample the relative contributions of the independent variables toward predicting the outcome measures. RESULTS: The models for sexual interest accounted for at least 33% of the variance, and the significant predictors common to the two samples were having a new partner since the diagnosis of breast cancer, mental health score, and body image score. For sexual dysfunction, the models in the two samples explained at least 33% of the variance, and the common significant predictors were vaginal dryness, past chemotherapy use, and having a new partner since diagnosis. The sexual satisfaction models explained at least 27% of the variance, with the common significant predictors being the quality of the partnered relationship and sexual problems in the partner. CONCLUSION: Among the predictors of sexual health, several are mutable (vaginal dryness, emotional well-being, body image, the quality of the partnered relationship, and sexual problems in the partner), and these should be considered for future interventions to address the sexual health and well-being of breast cancer survivors.

Psychotropic medication use among children in foster care: relationship to severe psychiatric disorders.

OBJECTIVES: This study sought to describe the level of psychotropic medication use and its relationship to severe psychiatric disorders among school-aged children in foster care. METHODS: Home interviews with 302 foster parents and children aged 6 to 12 years and 266 follow-up clinical evaluations were conducted. RESULTS: Thirteen percent of the children had taken psychotropic medication in the previous year, and 52% of those whose clinical status merited a medication evaluation had not received medication in the previous year. CONCLUSIONS: As the efficacy of psychotropic medication treatment for severe child psychiatric disorders becomes more established, research on the appropriateness of such care can begin.

Performance of a general location model with an ignorable missing-data assumption in a multivariate mental health services study.

In a study of the impact of case management teams in a publicly funded mental health programme, mental health patients were interviewed about a variety of outcomes suggestive of successful community adaptation, such as support from family and friends and avoidance of legal problems. Because outcome data were missing for a number of patients, a follow-up study was carried out to obtain this information form previous non-responders whenever possible. Because the data of interest were multivariate and included both continuous and categorical variables, a candidate approach for handling incomplete data in the absence of follow-up data would have been to fit a general location model, presumably with log-linear constraints on cell probabilities to avoid overfitting of the data. Here, we use available follow-up data to investigate the performance of a series of general location models with ignorable non-response. We note some problems with this approach and embed the discussion of this example in a broader consideration of the role of ignorable and non-ignorable models in applied research.