Knowledge and awareness of colorectal cancer among a predominantly Indigenous Caribbean community.

OBJECTIVE: To assess awareness levels and knowledge of colorectal cancer (CRC) and CRC screening among an Indigenous Caribbean community. METHODS: A community-based participatory research project was developed to perform a needs assessment of cancer prevention and education in an Indigenous non-metropolitan community in Dominica. Purposive sampling occurred at a local health clinic. Data was collected from 58 eligible patients via a 57-item structured interview. Descriptive statistics were calculated, and demographic correlates of CRC knowledge and awareness were assessed using chi-square and Fisher Exact tests. RESULTS: Of 58 participants, 72.4% identified as Indigenous, and 36.5% had heard of CRC. Most respondents (96.1%) believed CRC screening to be "important," yet only 3.0% of those who were age eligible had received screening in the prior 10 years, and 12.5% knew how to get screened. More respondents with incomes over $5,000 ECD had heard of CRC (72.2%) compared to those who had not (21.7%), and those who were unsure (16.7%, p < 0.01). Among those with a family cancer history, 14.3% knew how to get tested for CRC, 60.0% did not, and 25.0% were unsure (p < 0.03). CONCLUSION: Despite limited familiarity with CRC screening, participants broadly believed CRC screening to be important. Health education research is needed to develop patient-centered, culturally appropriate materials about CRC screening and prevention. Future work facilitating productive community partnerships and incorporating prevailing community traditions may align cancer prevention and education initiatives with community priorities.

Effectiveness of informational decision aids and a live donor financial assistance program on pursuit of live kidney transplants in African American hemodialysis patients.

BACKGROUND: African Americans have persistently poor access to living donor kidney transplants (LDKT). We conducted a small randomized trial to provide preliminary evidence of the effect of informational decision support and donor financial assistance interventions on African American hemodialysis patients' pursuit of LDKT. METHODS: Study participants were randomly assigned to receive (1) Usual Care; (2) the Providing Resources to Enhance African American Patients' Readiness to Make Decisions about Kidney Disease (PREPARED); or (3) PREPARED plus a living kidney donor financial assistance program. Our primary outcome was patients' actions to pursue LDKT (discussions with family, friends, or doctor; initiation or completion of the recipient LDKT medical evaluation; or identification of a donor). We also measured participants' attitudes, concerns, and perceptions of interventions' usefulness. RESULTS: Of 329 screened, 92 patients were eligible and randomized to Usual Care (n = 31), PREPARED (n = 30), or PREPARED plus financial assistance (n = 31). Most participants reported interventions helped their decision making about renal replacement treatments (62%). However there were no statistically significant improvements in LDKT actions among groups over 6 months. Further, no participants utilized the living donor financial assistance benefit. CONCLUSIONS: Findings suggest these interventions may need to be paired with personal support or navigation services to overcome key communication, logistical, and financial barriers to LDKT. TRIAL REGISTRATION: ClinicalTrials.gov [ NCT01439516 ] [August 31, 2011].

Evaluation of Neuropsychiatric Function in Phenylketonuria: Psychometric Properties of the ADHD Rating Scale-IV and Adult ADHD Self-Report Scale Inattention Subscale in Phenylketonuria.

BACKGROUND: Previous qualitative research among adults and parents of children with phenylketonuria (PKU) has identified inattention as an important psychiatric aspect of this condition. The parent-reported ADHD Rating Scale-IV (ADHD RS-IV) and the Adult ADHD Self-Report Scale (ASRS) have been validated for measuring inattention symptoms in persons with attention-deficit/hyperactivity disorder (ADHD); however, their psychometric attributes for measuring PKU-related inattention have not been established. OBJECTIVE: The primary objective of this investigation was to demonstrate the reliability, validity, and responsiveness of the ADHD RS-IV and ASRS inattention symptoms subscales in a randomized controlled trial of patients with PKU aged 8 years or older. METHODS: A post hoc analysis investigated the psychometric properties (Rasch model fit, reliability, construct validity, and responsiveness) of the ADHD RS-IV and ASRS inattention subscales using data from a phase 3b, double-blind, placebo-controlled clinical trial in those with PKU aged 8 years or older. RESULTS: The Rasch results revealed good model fit, and reliability analyses revealed strong internal consistency reliability (α ≥ 0.87) and reproducibility (intraclass correlation coefficient ≥ 0.87) for both measures. Both inattention measures demonstrated the ability to discriminate between known groups (P < 0.001) created by the Clinical Global Impression-Severity scale. Correlations between the ADHD RS-IV and the ASRS with the Clinical Global Impression-Severity scale and the age-appropriate Behavior Rating Inventory of Executive Function Working Memory subscale were consistently moderate to strong (r ≥ 0.56). Similarly, results of the change score correlations were of moderate magnitude (r ≥ 0.43) for both measures when compared with changes over time in Behavior Rating Inventory of Executive Function Working Memory subscales. CONCLUSIONS: These findings of reliability, validity, and responsiveness of both the ADHD RS-IV and the ASRS inattention scales, in addition to content validation results, support their use for the assessment of inattention symptoms among persons with PKU aged 8 years or older in both clinical and research settings.

Comparison of life participation activities among adults treated by hemodialysis, peritoneal dialysis, and kidney transplantation: a systematic review.

BACKGROUND: A comprehensive assessment of the association of patients' renal replacement therapy (RRT) modality with their participation in life activities (physical function, travel, recreation, freedom, and work) is needed. STUDY DESIGN: Systematic review of peer-reviewed published studies. SETTING & POPULATION: Adults undergoing RRT (hemodialysis, peritoneal dialysis, or transplantation). SELECTION CRITERIA FOR STUDIES: We searched PubMed, Cochrane Library, and EMBASE from January 1980 through April 2012 for English-language articles that compared participation in life activities among patients receiving: (1) hemodialysis compared with peritoneal dialysis, (2) hemodialysis compared with kidney transplantation, or (3) peritoneal dialysis compared with kidney transplantation. PREDICTOR: RRT modality. OUTCOMES: Reported rates of physical function, travel, recreation, freedom, and work-related activities by RRT modality. RESULTS: 46 studies (6 prospective cohort, 38 cross-sectional, and 2 pre-post transplantation) provided relevant comparisons of life participation activities among patients treated with hemodialysis, peritoneal dialysis, and kidney transplantation. Studies were conducted in 1985-2011 among diverse patient populations in 16 distinct locations. A majority of studies reported greater life participation rates for patients with kidney transplants compared with patients receiving either hemodialysis or peritoneal dialysis. In contrast, a majority of studies reported no differences in outcomes between patients receiving hemodialysis and patients receiving peritoneal dialysis. These results were consistent throughout the study period, across diverse populations, and among the subset of studies that performed appropriate adjustments for potential confounding factors. LIMITATIONS: Many studies included in the review had significant design weaknesses. CONCLUSIONS: Evidence suggests that patients with kidney transplants may experience better rates of life participation compared with patients receiving dialysis, whereas patients receiving hemodialysis and patients receiving peritoneal dialysis may experience similar rates of life participation. Rigorously performed studies are needed to better inform patients about the association of RRT with these important patient-reported outcomes.

Selecting renal replacement therapies: what do African American and non-African American patients and their families think others should know? A mixed methods study.

BACKGROUND: Little is known regarding the types of information African American and non-African American patients with chronic kidney disease (CKD) and their families need to inform renal replacement therapy (RRT) decisions. METHODS: In 20 structured group interviews, we elicited views of African American and non-African American patients with CKD and their families about factors that should be addressed in educational materials informing patients' RRT selection decisions. We asked participants to select factors from a list and obtained their open-ended feedback. RESULTS: Ten groups of patients (5 African American, 5 non-African American; total 68 individuals) and ten groups of family members (5 African American, 5 non-African American; total 62 individuals) participated. Patients and families had a range (none to extensive) of experiences with various RRTs. Patients identified morbidity or mortality, autonomy, treatment delivery, and symptoms as important factors to address. Family members identified similar factors but also cited the effects of RRT decisions on patients' psychological well-being and finances. Views of African American and non-African American participants were largely similar. CONCLUSIONS: Educational resources addressing the influence of RRT selection on patients' morbidity and mortality, autonomy, treatment delivery, and symptoms could help patients and their families select RRT options closely aligned with their values. Including information about the influence of RRT selection on patients' personal relationships and finances could enhance resources' cultural relevance for African Americans.

The providing resources to enhance African American patients' readiness to make decisions about kidney disease (PREPARED) study: protocol of a randomized controlled trial.

BACKGROUND: Living related kidney transplantation (LRT) is underutilized, particularly among African Americans. The effectiveness of informational and financial interventions to enhance informed decision-making among African Americans with end stage renal disease (ESRD) and improve rates of LRT is unknown. METHODS/DESIGN: We report the protocol of the Providing Resources to Enhance African American Patients' Readiness to Make Decisions about Kidney Disease (PREPARED) Study, a two-phase study utilizing qualitative and quantitative research methods to design and test the effectiveness of informational (focused on shared decision-making) and financial interventions to overcome barriers to pursuit of LRT among African American patients and their families. Study Phase I involved the evidence-based development of informational materials as well as a financial intervention to enhance African American patients' and families' proficiency in shared decision-making regarding LRT. In Study Phase 2, we are currently conducting a randomized controlled trial in which patients with new-onset ESRD receive 1) usual dialysis care by their nephrologists, 2) the informational intervention (educational video and handbook), or 3) the informational intervention in addition to the option of participating in a live kidney donor financial assistance program. The primary outcome of the randomized controlled trial will include patients' self-reported rates of consideration of LRT (including family discussions of LRT, patient-physician discussions of LRT, and identification of a LRT donor). DISCUSSION: Results from the PREPARED study will provide needed evidence on ways to enhance the decision to pursue LRT among African American patients with ESRD.

Development of a decision aid to inform patients' and families' renal replacement therapy selection decisions.

BACKGROUND: Few educational resources have been developed to inform patients' renal replacement therapy (RRT) selection decisions. Patients progressing toward end stage renal disease (ESRD) must decide among multiple treatment options with varying characteristics. Complex information about treatments must be adequately conveyed to patients with different educational backgrounds and informational needs. Decisions about treatment options also require family input, as families often participate in patients' treatment and support patients' decisions. We describe the development, design, and preliminary evaluation of an informational, evidence-based, and patient-and family-centered decision aid for patients with ESRD and varying levels of health literacy, health numeracy, and cognitive function. METHODS: We designed a decision aid comprising a complementary video and informational handbook. We based our development process on data previously obtained from qualitative focus groups and systematic literature reviews. We simultaneously developed the video and handbook in "stages." For the video, stages included (1) directed interviews with culturally appropriate patients and families and preliminary script development, (2) video production, and (3) screening the video with patients and their families. For the handbook, stages comprised (1) preliminary content design, (2) a mixed-methods pilot study among diverse patients to assess comprehension of handbook material, and (3) screening the handbook with patients and their families. RESULTS: The video and handbook both addressed potential benefits and trade-offs of treatment selections. The 50-minute video consisted of demographically diverse patients and their families describing their positive and negative experiences with selecting a treatment option. The video also incorporated health professionals' testimonials regarding various considerations that might influence patients' and families' treatment selections. The handbook was comprised of written words, pictures of patients and health care providers, and diagrams describing the findings and quality of scientific studies comparing treatments. The handbook text was written at a 4th to 6th grade reading level. Pilot study results demonstrated that a majority of patients could understand information presented in the handbook. Patient and families screening the nearly completed video and handbook reviewed the materials favorably. CONCLUSIONS: This rigorously designed decision aid may help patients and families make informed decisions about their treatment options for RRT that are well aligned with their values.

Awareness and Knowledge of HPV, HPV Vaccination, and Cervical Cancer among an Indigenous Caribbean Community.

Caribbean women experience a cervical cancer incidence rate that is three times higher than that among their North American counterparts. In this study, we performed a needs assessment of the knowledge and awareness of HPV, HPV vaccination, and cervical cancer and receipt of cervical cancer screening among an indigenous Caribbean community. We purposively recruited individuals aged ≥18 from a community health care clinic (n = 58) to complete a 57-item structured interview including items on demographics, cancer history, knowledge and awareness of HPV, HPV vaccines, cervical cancer, and cervical cancer screening. Participants' mean age was 47.1 years (SD: 14.4). Most were female (74.1%), were married/partnered (51.7%), had primary education (63.8%), and identified as Kalinago (72.4%). Whereas 79.5% had heard of cervical cancer, few had heard of HPV (19.6%) or the HPV vaccine (21.8%). Among those who knew someone with cancer, 90.9% had heard of the HPV vaccine, compared with only 9.1% of those who did not know anyone with cancer (p = 0.02). Access to HPV vaccination is an immediate, cost-effective cancer prevention priority for reducing the disproportionate burden of HPV-related cancers, particularly cervical cancer, in the Caribbean. We recommend culturally targeted education interventions to improve knowledge about HPV vaccination and the link between HPV and cervical cancer.

Lower estimated glomerular filtration rate and higher albuminuria are associated with all-cause and cardiovascular mortality. A collaborative meta-analysis of high-risk population cohorts.

Screening for chronic kidney disease is recommended in people at high risk, but data on the independent and combined associations of estimated glomerular filtration rate (eGFR) and albuminuria with all-cause and cardiovascular mortality are limited. To clarify this, we performed a collaborative meta-analysis of 10 cohorts with 266,975 patients selected because of increased risk for chronic kidney disease, defined as a history of hypertension, diabetes, or cardiovascular disease. Risk for all-cause mortality was not associated with eGFR between 60-105 ml/min per 1.73 m², but increased at lower levels. Hazard ratios at eGFRs of 60, 45, and 15 ml/min per 1.73 m² were 1.03, 1.38 and 3.11, respectively, compared to an eGFR of 95, after adjustment for albuminuria and cardiovascular risk factors. Log albuminuria was linearly associated with log risk for all-cause mortality without thresholds. Adjusted hazard ratios at albumin-to-creatinine ratios of 10, 30 and 300 mg/g were 1.08, 1.38, and 2.16, respectively compared to a ratio of five. Albuminuria and eGFR were multiplicatively associated with all-cause mortality, without evidence for interaction. Similar associations were observed for cardiovascular mortality. Findings in cohorts with dipstick data were generally comparable to those in cohorts measuring albumin-to-creatinine ratios. Thus, lower eGFR and higher albuminuria are risk factors for all-cause and cardiovascular mortality in high-risk populations, independent of each other and of cardiovascular risk factors.

Reliability of GFR formulas based on serum creatinine, with special reference to the MDRD Study equation.

Estimation of glomerular filtration rate (GFR) is central to the diagnosis, evaluation and management of chronic kidney disease (CKD). This review summarizes data on the performance of equations using serum creatinine to estimate GFR, particularly the Modification of Diet in Renal Disease (MDRD) Study equation. The size of studies evaluating GFR estimation equations and their level of sophistication in estimating bias, precision, validity and sensitivity to the source population have improved over the past decade. We update our review from 2006, which included 7 studies with over 500 individuals and 12 studies with 50-499 individuals with measured GFR evaluating the MDRD Study and Cockcroft-Gault equations. More recent studies include an individual level pooling analysis of 5504 participants in 10 studies which showed that creatinine calibration to reference methods improved the performance of the MDRD Study equation but increased bias for the Cockcroft-Gault equation. The MDRD Study equation had a bias of 3.0 %, interquartile range of 29.0 % and percentage of estimates within 30 % of the measured GFR value (P(30)) of 82 % for estimates below 60 mL/(min x 1.73 m(2)). Above this value, the bias was greater (8.7 %) and estimates are less useful since 30 % error is a large absolute error in GFR. Results vary across studies but are generally similar with disappointing performance in the high GFR range, which is of particular interest in early diabetic nephropathy. New equations using serum creatinine can reduce the bias present in the high GFR range but are unlikely to dramatically improve precision, suggesting a need for additional markers. Finally, algorithms are needed to tailor clinical practice based on data from GFR estimates and other participant characteristics, including the source population and level of proteinuria.

Patient-reported Symptom Experiences in Patients With Carcinoid Syndrome After Participation in a Study of Telotristat Etiprate: A Qualitative Interview Approach.

PURPOSE: Telotristat etiprate, a tryptophan hydroxylase inhibitor, was previously evaluated in a Phase II randomized, placebo-controlled clinical trial in patients with carcinoid syndrome (CS) and diarrhea not adequately controlled by octreotide. The objective of the current study was to characterize the symptom experiences of patients participating in that trial. METHODS: Consenting patients participated in one-on-one, qualitative interviews focused on eliciting symptoms they had experienced in association with their CS diagnosis and recollection of symptom changes they experienced while participating in the Phase II trial. FINDINGS: Among the 23 patients who participated in the previous 4-week dose-escalation study, 16 were eligible for interviews and 11 participated in the present study. The median time from study completion to the interview was 31 months; 4 of 11 patients were receiving telotristat etiprate in a follow-up, open-label trial at the time of interview. All of the patients (100%) described diarrhea as a symptom of CS, with effects on the emotional, social, and physical aspects of their lives. Improvement in diarrhea during the study was described by 82% of participants, and was very impactful in several patients. Results led to the design and implementation of a larger interview program in Phase III and helped to establish a definition of clinically meaningful change for the clinical development program. IMPLICATIONS: The diarrhea associated with CS can have a large impact on daily lives, and patient interviews can characterize and capture clinically meaningful improvements with treatment. ClinicalTrials.gov Identifier: NCT00853047.

Identifying an important change estimate for the Multiple Sclerosis Walking Scale-12 (MSWS-12v1) for interpreting clinical trial results.

BACKGROUND: The 12-question Multiple Sclerosis Walking Scale (MSWS-12v1) is a widely-used patient-reported outcome (PRO) measure of walking ability in multiple sclerosis (MS). OBJECTIVE: To estimate the magnitude of an important change in MSWS-12v1 scores for the interpretation of meaningful subject-level improvements across a 6-month trial of MS patients with walking disability. METHODS: MOBILE was a 6-month exploratory study assessing fampridine's effect on walking ability in 132 people with MS. Three PRO measures assessed walking ability: MSWS-12v1, EuroQol 5-Dimension-5 Level (EQ-5D-5L) mobility question, and a patient global impression of change (PGIC) in overall walking ability. Pre-specified anchor- and distribution-based analyses estimated the MSWS-12v1 change scores representing an important change for participants. Results were triangulated to propose a single best value indicating meaningful improvement. RESULTS: Using baseline to week 2 through week 24 change scores, anchor-based analyses demonstrated mean and median improvements of 5.2-6.6 (PGIC) and 9.7-13.4 (EQ-5D-5L mobility) points on the MSWS-12v1, indicating meaningful improvements. The distribution-based estimate was 6.8 points. Triangulation across the results suggested an 8-point reduction in MSWS-12v1 score represents an important subject-level change in these participants. CONCLUSION: In similar MS clinical trials, an 8-point improvement on the MSWS-12v1 is a reasonable estimate of meaningful improvement in walking ability.

Psychometric properties of the Dependence Scale in large randomized clinical trials of patients with mild and moderate Alzheimer's disease.

OBJECTIVE: The need for assistance from others is a hallmark concern in Alzheimer's disease (AD). The psychometric properties of the Dependence Scale (DS) for measuring treatment benefit were investigated in large randomized clinical trials of patients with mild to moderate AD. METHODS: Reliability, validity, and responsiveness of the DS were examined. Path models appraised relationships and distinctiveness of key AD measures. The responder definition was empirically derived. RESULTS: Generally acceptable reliability (α ≥ .65), significant (P < .001) known-groups tests, and moderate to strong correlations (r ≥ .31) confirmed the DS psychometric properties. Path models supported relationships and distinctiveness of key AD measures. A DS change of ≤ 1 point for patients with limited home care and ≤ 2 points for patients with assisted living care best described stability of the level of dependence on caregivers. CONCLUSION: The DS is a psychometrically robust measure in mild to moderate AD. The empirically derived responder definition aids in the interpretation of DS change.

Content Validity of the ADHD Rating Scale (ADHD RS-IV) and Adult ADHD Self-Report Scale (ASRS) in Phenylketonuria

Abstract The ADHD Rating Scale (ADHD RS-IV; parent report) and Adult ADHD Self-Rating Scale (ASRS; self-report) are validated instruments for measuring symptoms of attention-deficit/hyperactivity disorder (ADHD). The objectives of this study were to elicit descriptions of phenylketonuria (PKU) symptoms and assess content validity of these instruments in PKU. Parents (N = 15) of children with PKU (?8 years old) and adults with PKU (N=13) described PKU-related symptoms and commented on the scale's clarity, comprehensiveness, and relevance to their experience with PKU. Most of the adults (84.6%) and all of the children were on a phenylalanine-restricted diet, according to respondent report. The inattentiveness symptoms reported by participants mapped to the inattentive items of the questionnaires. Most participants felt the inattentive items were clear and relevant to their experience. Despite study design limitations, these results demonstrate the relevance of assessing inattentiveness in PKU, and both instruments achieved content validity for inattentive subscale items.