Reaching adults who smoke cigarettes in rural Appalachia: Rationale, design & analysis plan for a mixed-methods study disseminating pharmacy-delivered cessation treatment.

INTRODUCTION: Unlike other U.S. geographical regions, cigarette smoking prevalence remains stagnant in rural Appalachia. One avenue for reaching rural residents with evidence-based smoking cessation treatments could be utilizing community pharmacists. This paper describes the design, rationale, and analysis plan for a mixed-method study that will determine combinations of cessation treatment components that can be integrated within community pharmacies in rural Appalachia. The aim is to quantify the individual and synergistic effects of five highly disseminable and sustainable cessation components in a factorial experiment. METHODS: This sequential, mixed-method research design, based on the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework, will use a randomized controlled trial with a 25 fully crossed factorial design (32 treatment combinations) to test, alone and in combination, the most effective evidence-based cessation components: (1) QuitAid (yes vs. no) (2) tobacco quit line (yes vs. no) (3) SmokefreeTXT (yes vs. no) (4) combination NRT lozenge + NRT patch (vs. NRT patch alone), and (5) eight weeks of NRT (vs. standard four weeks). RESULTS: Logistic regression will model abstinence at six-months, including indicators for the five treatment factors and all two-way interactions between the treatment factors. Demographic and smoking history variables will be considered to assess potential effect modification. Poisson regression will model quit attempts and percent of adherence to treatment components as secondary outcomes. CONCLUSION: This study will provide foundational evidence on how community pharmacies in medically underserved, rural regions can be leveraged to increase utilization of existing evidence-based tobacco cessation resources for treating tobacco dependence. CLINICAL TRIALS: NCT05660525.

Impact of comorbidities and treatment burden on general well-being among women's cancer survivors.

BACKGROUND: Gains in cancer detection and treatment have meant that more patients are now living with both cancer and other chronic health conditions, which may become burdensome. We used the Patient Experience with Treatment and Self-Management (PETS) framework to study challenges in self-management and its impact on health among survivors of women's cancers who are caring for other chronic health conditions. METHODS: Applicability of the PETS domains among survivors of women's cancers with comorbidities was assessed in focus groups to create the study survey. Women surviving primary breast, cervical, ovarian, or endometrial/uterine cancer treated between 6 months and 3 years prior at two large healthcare systems in Virginia were mailed study invitation letters to complete a telephone-based survey. The survey included questions on cancer treatment history, comorbid conditions prior to cancer, treatment and self-management experiences, health literacy, financial security, and items on self-management activities, self-management difficulties and self-management impact (i.e., role/social activity limitations and physical/mental exhaustion). Additionally, general health was assessed with items from the Patient-Reported Outcomes Measurement Information System (PROMIS). Hierarchical regression models and path analysis were used to examine correlates of self-management impact on general physical health (GPH) and mental health (GMH). RESULTS: Of 1448 patients contacted by mail, 274 (26%) returned an interest form providing their consent to be contacted. Of these, 183 completed the survey. Reasons for non-completion included ineligibility (42), unable to be reached (33) and refusal (6). The majority were survivors of breast (58%) or endometrial/uterine cancer (28%), and 45% resided in non-urban locations. After adjusting for age, race, and cancer type, survivors with higher self-management difficulty reported higher self-management impact, which was associated with lower perceived general health. Reports of higher self-management impact was associated with being single or unmarried, white race, fulltime employed, higher financial insecurity, lower health literacy and more comorbidities. In path analysis, self-management impact was a significant mediator in the association of comorbidity and financial insecurity on GPH and GMH. CONCLUSIONS: Among survivors of women's cancer, pre-diagnosis comorbidity, health literacy, and financial security are associated with psychosocial impact of self-management and general physical and mental health in the 6 month to 3-year period after cancer treatment has ended. The impact of self-management on psychosocial functioning is an important factor among cancer survivors caring for multiple chronic health conditions. This study provides evidence on the importance of assessing cancer survivors' self-management difficulties such as in future interventions to promote health and wellness.

XactMice: humanizing mouse bone marrow enables microenvironment reconstitution in a patient-derived xenograft model of head and neck cancer.

The limitations of cancer cell lines have led to the development of direct patient-derived xenograft models. However, the interplay between the implanted human cancer cells and recruited mouse stromal and immune cells alters the tumor microenvironment and limits the value of these models. To overcome these constraints, we have developed a technique to expand human hematopoietic stem and progenitor cells (HSPCs) and use them to reconstitute the radiation-depleted bone marrow of a NOD/SCID/IL2rg(-/-) (NSG) mouse on which a patient's tumor is then transplanted (XactMice). The human HSPCs produce immune cells that home into the tumor and help replicate its natural microenvironment. Despite previous passage on nude mice, the expression of epithelial, stromal and immune genes in XactMice tumors aligns more closely to that of the patient tumor than to those grown in non-humanized mice-an effect partially facilitated by human cytokines expressed by both the HSPC progeny and the tumor cells. The human immune and stromal cells produced in the XactMice can help recapitulate the microenvironment of an implanted xenograft, reverse the initial genetic drift seen after passage on non-humanized mice and provide a more accurate tumor model to guide patient treatment.

Glycaemia and correlates of patient-reported outcomes in ACCORD trial participants.

AIMS: Post-hoc evaluation of relationships between first-year change in glycaemic control (HbA(1c) ) and change in patient-reported outcomes among ACCORD health-related quality of life (HRQoL) substudy participants. METHODS: Data from 2053 glycaemia-trial subjects were analysed. We assessed physical and mental health status (36-Item Short Form Health Survey, Version-2), symptom count and severity (Diabetes Symptoms Distress Checklist) and treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire). Linear mixed models were used to test relationships between 1-year changes in HbA(1c) and patient reported outcomes sequentially adjusting for correlates (baseline characteristics, baseline patient reported outcomes, treatment assignment, frequency of clinical contact and post-randomization weight change plus new complications). RESULTS: Poorer baseline control of HbA(1c) and cardiovascular disease risk factors predicted greater one-year improvements in treatment satisfaction. Similarly, poorer baseline patient reported outcome scores all individually predicted greater 1-year improvement in that same outcome. Accounting for baseline and post-randomization characteristics and treatment arm, 1-year change in HbA(1c) was unrelated to changes in overall physical or mental health; however, every one percentage-point (10.9 mmol/mol) reduction in HbA(1c) was associated with lower symptom count (ß = 0.599; P = 0.012), lower symptom distress (ß = 0.051; P = 0.001), and higher treatment satisfaction (ß = -2.514; P < 0.001). CONCLUSIONS: Independent of all relevant covariates, better glycaemic control over 1 year was associated with reduced patient-reported diabetes symptoms and symptom distress, and increased treatment satisfaction, but not overall physical and mental health. Further investigation is required to understand the specific psychosocial mechanisms that affect how patients value health and treatments.

Investigating correlates of health related quality of life in a low-income sample of patients with diabetes.

OBJECTIVE: We sought to describe and find correlates of health-related quality of life among under-served low-income patients in North Carolina with diabetes mellitus. METHODS: A telephone survey of 310 patients recording quality of life, patient satisfaction, self-reported health, and patient complaints was conducted as part of a diabetes care improvement project. Demographic and clinical records were available for 249 of these patients: 69% were female, 45% were minority, and 84% had type 2 diabetes. Ages ranged from 18 to 88 years with a mean of 56. Quality of life indices consisted of SF-36 physical functioning, mental health and diabetes-39 sub-scores. RESULTS: Comparison to SF-36 norms showed the sample had lower sub-scores than expected. The multivariate analysis suggested that being within an acceptable metabolic control predicted better quality of life physically, mentally, and sexually. Strong associations were detected between most sub-scores and complaints involving legs and feet, self-rated vision, and hassles in self-management. CONCLUSIONS: The consistent associations between the sub-scores and complaints, symptoms, and hassles underscore the strong relationship quality of life may share with the severity of diabetes complications as well as with psychosocial factors. Significantly lower quality of life in this sample highlights the need to improve the care of minority low-income diabetes patients.

Effect of prescription benefit changes on medical care utilization in a Medicare HMO population.

OBJECTIVE: To examine the impact of 2 cost-containment efforts in prescription benefits in successive years that included changes in copayment and coverage levels, expanded generic coverage, and brand name prescription drug limit-of-coverage in a Medicare health maintenance organization (HMO). The benefit changes included moving to a drug benefit with increased total coverage and higher copayments in the first year (1998) and to one with brand name limit-of-coverage and unlimited generic availability in the second year (1999). STUDY DESIGN: A repeated-measures analytical design with enrollee follow-up before and after introduction of the 2 policies. PATIENTS AND METHODS: A cohort of 2411 older adults continuously enrolled in a Medicare HMO since 1998 was followed up for 1 year pre-post for healthcare service utilization and costs; 259 patients enrolled since 1997 were available to test the effects of the first policy change. RESULTS: Bivariate and multivariate analyses found a significant decrease of 27% in prescription costs, a 4% decrease in physician visits, and a 6% decrease in total costs associated with the change in prescription benefit in the second year (1999). The policy change in the first year (1998) resulted in a 29% increase in prescription costs and 38% increased total costs for the HMO. CONCLUSIONS: Introduction of a prescription benefit that included substantial brand name limit-of-coverage and generic drug coverage expansion was associated with significantly reduced prescription costs. In addition, this change did not seem to increase nonprescription-related healthcare service use in the population.

Magnetic resonance imaging in ophthalmoplegic migraine of children.

PURPOSE: To present 2 children with ophthalmoplegic migraine and characteristic magnetic resonance imaging (MRI) findings post enhancement with gadopentetate dimeglumine diethylenetriamine pentaacetic acid (Gd-DTPA). METHODS: Two patients, ages 3 years and 7 years, underwent MRI during the acute phases of a recurring oculomotor palsy. MRI was repeated several weeks later as symptoms resolved. RESULTS: In both cases, enhancement and thickening of the cisternal segment of the oculomotor nerve were present at initial presentation. Ophthalmoplegia resolved spontaneously in 1 child and after steroid treatment in the other. Both postresolution MRIs demonstrated decrease in enhancement and thickening of the third nerve. CONCLUSIONS: The enhancing, thickened lesion identified on MRI in our patients may represent an inflammatory process similar to Tolosa-Hunt syndrome occurring in the interpeduncular segment of the oculomotor nerve. Patients with ophthalmoplegic migraine may, therefore, benefit from the use of steroids. MRI of the brain post enhancement is a useful adjunct in the diagnosis and treatment of ophthalmoplegic migraine and should be considered as part of a workup of ophthalmoplegic migraine in children.

A qualitative analysis of women's satisfaction with primary care from a panel of focus groups in the National Centers of Excellence in Women's Health.

Health issues unique to women and differences in healthcare experiences have recently gained attention as health plans and systems seek to extend and improve health promotion and disease prevention in the population. Successful efforts focused on enhancing quality of care will require information from the patient's perspective on how to improve such services to best support women's attempts to lead healthy and productive lives. The National Centers of Excellence in Women's Health program (CoE), sponsored by the Office on Women's Health within the Department of Health and Human Services, is based on an integrated model uniting research, training, healthcare, and community education and outreach. To examine women's concept and definitions of healthcare quality, 18 focus groups comprising 137 women were conducted nationwide on experiences and attributes of healthcare that women value in primary care. Following the focus groups, a woman-focused healthcare satisfaction instrument was developed for the purpose of assessing and improving healthcare delivery. We describe the qualitative results of the focus group study.

Quality of diabetes care among low-income patients in North Carolina.

BACKGROUND: Diabetes is a leading cause of death and disability, disproportionately affecting most ethnic minority groups, people of low socioeconomic status, the elderly, and people in rural areas. Despite the availability of evidence-based clinical recommendations, barriers exist in the delivery of appropriate diabetes care. The purpose of this study is to examine the level of diabetes care among low-income populations in North Carolina. METHODS: Baseline medical record abstractions were performed (N=429) on diabetic patients at 11 agencies serving low-income populations (community health centers, free clinics, primary care clinics, and public health clinics) across the state participating in a quality-of-diabetes-care initiative. Data were collected for four process (measurement of glycosylated hemoglobin and lipids, dilated eye examination, nephropathy assessment) and two outcome (glycemic and lipid control) measures based on the Diabetes Quality Improvement Project (DQIP) and the Health Plan Employer Data and Information Set (HEDIS), and three additional indicators (blood pressure measurement and control, and lower limb assessment). Compliance rates to individual measures were calculated overall and by demographic and health characteristics. RESULTS: Diabetes care compliance rates ranged from 77.9% for blood pressure testing to 3.3% for complete foot examinations. Differences in care were observed by age, insulin use, and prevalent disease. CONCLUSIONS: This study indicates low compliance with diabetes care guidelines in underserved North Carolinians, and inconsistency of care according to some demographic and health characteristics. These results stress the need for quality improvement initiatives that enhance the level of care received by patients with diabetes, particularly those most vulnerable to diabetes and its complications.

Learning an invented inflectional morpheme in Spanish by children with typical language skills and with specific language impairment (SLI).

Cross-linguistic research on SLI has suggested that how the disorder is manifested depends on the ambient language. For example, research on Italian indicates that SLI children do not present difficulties with verb inflection, when compared with MLU-matched peers. This pattern contrasts with what has been reported for English-speaking children. The present investigation sought to examine SLI children's use of inflectional morphology through a language teaching task similar to that used by Connell (1987) and Connell and Stone (1992). To address cross-linguistic differences, children were speakers of a language similar to Italian in its verb agreement paradigm. Sixteen Puerto Rican Spanish-speaking with SLI and 16 age-matched controls were taught a subject-verb agreement suffix that established the subject's gender. Half the children in each group were taught the new form via imitation. The rest of the participants were trained via a modeling procedure. Both comprehension and production of the target form were assessed. Results indicated significant differences across the SLI and typical groups for both comprehension and production of the inflectional morpheme, regardless of instructional strategy. These findings contradict what has been observed in previous studies on teaching an invented rule to children with SLI. They also suggest that inflectional morphology may be problematic even for children who are learning a morphologically rich language. The explanatory power of the process account and the linguistic account of SLI are explored as these pertain to the present findings, and suggestions for further research are discussed.

Predictive power of a risk-assessment questionnaire across different disease states: results in an elderly managed care enrolled population.

OBJECTIVE: To examine the predictive power of self-reported assessment questionnaire data to explain changes in healthcare service utilization and expenditures of a population of Medicare health maintenance organization enrollees during a 2-year period. STUDY DESIGN: A prospective cohort study with a 2-year postenrollment follow-up period. Multiple robust regression analyses were conducted to examine associations among self-reported health status variables obtained from responses to the questionnaire. SAMPLE AND METHODS: Participants were administered a voluntary comprehensive questionnaire at enrollment that collected self-reported information on morbidity, health status, perceptions of health, and healthcare service utilization during the preenrollment year. Questionnaire responses were combined with actual 2-year postenrollment claims data. For the complete follow-up period, 4128 patients were available. RESULTS: Participants with such chronic conditions as depression and diabetes were likelier than the average enrollee to have higher healthcare service utilization. Self-reported health status predictors examined in this study explained a larger percentage of the variance (as much as 20%) in such chronic conditions as cancer and depression. Despite evidence of underreporting of preenrollment healthcare service utilization, these variables were highly predictive of actual postenrollment utilization patterns. CONCLUSIONS: Self-reported health status information collected at baseline is as predictive of postenrollment risk as are currently used traditional approaches that require archival healthcare service utilization data. In addition, this approach is sensitive to changes in healthcare service utilization across differing morbidity states in older adults.

Effects of allergic dermatosis on health-related quality of life.

Allergic dermatosis is a class of immunologic skin diseases manifested as intense itching, which potentially leads to a cycle of skin pain, damage, and infection. Information collected from clinical samples on health-related quality of life shows that some individuals may suffer from poor-quality sleep, physical and emotional distress, and limitations in social functioning. Although many individual factors may moderate the impact of disease on quality of life, disease severity is consistently linked to amount of limitation. There are only sparse data from population surveys in which participants are not selected based on willingness to join a treatment trial for relief of symptoms. This article presents quality-of-life and disease burden data on 559 persons in a community survey who reported signs and symptoms consistent with allergic dermatosis. Quality of life was assessed using the Dermatology-specific Quality of Life (DSQL) questionnaire. Overall, greater disease severity was associated with higher DSQL scores. Noticeable deficits were reported among those who rated their disease as moderate or severe, especially in terms of physical discomfort, sleep disturbance, and negative self-perceptions and emotions. These complaints correlated significantly with out-of-pocket expenses for lotions and emollients to control skin disease. Despite these complaints, the median number of days from the last primary healthcare visit was 453 days, indicating that many dermatosis sufferers are not accessing expert medical care that could alleviate distress.

Caregivers' unmet needs for support in caring for functionally impaired elderly persons: a community sample.

Few estimates have been made of the extent to which the needs of caregivers are met. In addition to the inadequate capacity of services, many caregivers lack adequate financial resources, social resources, or other means to access them. Caregivers who provide services to minority or poor elderly may be particularly needy since their care receivers tend to be less healthy and are less likely to use institutional facilities. To address this issue, the authors studied a community sample of 124 caregivers who identified correlates of their perceived unmet caregiver needs and their use of supportive services available for their caregiving. Results indicated that 51.8 percent of women and 67.4 percent of men reported needs for one or more community services that were not met. It was concluded that caregivers who are poor or who required financial assistance are at the highest risk for needing assistance while providing caregiving services. Community services may more effectively target potential needs of caregivers through routine screenings.

Issues of aging and adherence to health interventions.

This review article describes several processes and considerations that are important to adherence in aging research and potential strategies that could be used to facilitate adherence among older adults. In many large aging trials participants are purposefully selected to reduce the risk of suboptimal adherence and retention. This selection often involves screening out those with barriers such as transportation needs, sensory deficits, functional dependence, major diseases limiting life expectancy, or apparent psychological distress. However, trends toward extending interventions to the general population of older adults require specific knowledge about the circumstances and processes that support adherence among older adults or the conditions that make them vulnerable to adherence problems. Addressing the diversity of needs, expectations, and capabilities of older adults that promote adherence is a key consideration in aging research. Control Clin Trials 2000;21:171S-183S

Emerging techniques for anaerobic bioremediation of contaminated environments.

Over the past decade, it has been recognized that the diversity of anaerobic microbial metabolism is far greater than was previously assumed, and that many contaminants previously considered to be recalcitrant under anoxic conditions can in fact be biotransformed in the absence of molecular oxygen. Here, we summarize recent advances in the understanding of novel forms of anaerobic microbial metabolism and their potential application to bioremediative technologies.

Self-reported health status predictors of healthcare services utilization and charges in elderly asthmatic patients.

This study examined the associations between self-reported health status predictors and healthcare service utilization in a cohort of elderly asthmatic patients. The results of the study showed a strong association among self-reported prior healthcare utilization, comorbidities, patient's perception of health status, and self-reported quality of life with healthcare service utilization and charges. A large amount of variance in healthcare service utilization and charges in this population was explained by these factors. Patient's self-reported health status could be important in earlier detection of high-risk older adults with asthma, and targeting them for disease management interventions.

Race, socioeconomic status, and cause-specific mortality.

PURPOSE: Life expectancy for black Americans is five to eight years less than for Whites. The socioeconomic status (SES) of Blacks is also less than for Whites, and SES is associated with early mortality. This paper estimates the proportion of the racial difference in mortality attributable to SES by specific causes of death. METHODS: Data on 453,384 individuals in the National Longitudinal Mortality Study were used to estimate the hazard ratio associated with black race, with and without adjustment for income and education (measures of SES), in 38 strata defined by cause of death and age. RESULTS: For women, SES accounted for much (37-67%) of the black excess mortality for accidents, ischemic heart disease (ages 35-54), diabetes, and homicide; but not for hypertension, infections, and stomach cancers (11-17%). For men, SES accounted for much of the excess risk (30-55%) for accidents, lung cancer, stomach cancer, stroke, and homicide; but not for prostate cancer, pulmonary diseases, hypertension, and cardiomyopathy (0-17%). CONCLUSIONS: These results confirm those specific causes of death likely to underlie the overall excess mortality of Blacks, and identify those causes where SES may play a large role.