Multiple Stakeholder Views on Data Sharing in a Biobank in an Integrated Healthcare Delivery System: Implications for Biobank Governance.

BACKGROUND: Beginning in 2005, researchers at Kaiser Permanente Northern California (KPNC) Division of Research developed the Research Program on Genes, Environment, and Health (RPGEH), a research resource of linked biospecimens, health surveys, and electronic health records on more than 200,000 adult KPNC members. This study examined multiple stakeholders' values and preferences regarding protection of participants' privacy and wide sharing of participant data by RPGEH. METHODS: We conducted 45 semi-structured interviews in person or via phone and two focus groups with seven stakeholder groups, including RPGEH participants and decliners who are KPNC members, KPNC research scientists, external scientists, leadership, Human Subjects Research Protection Program staff, and RPGEH Community Advisory Panel members. RESULTS: Three major themes emerged related to: (1) perceived individual and social harms associated with data sharing; (2) concerns to address when governing access to RPGEH data; and (3) impact of a blurred boundary between research and clinical care in the context of biobanking. CONCLUSIONS: The study results were considered in the development of RPGEH data governance and motivated the inclusion of KPNC Community Advisory Panel members and ELSI experts on committees that evaluate data access proposals. Our findings can help inform other biobanks going through similar processes developing data sharing and access policies.

Caregiving and mutuality among long-term colorectal cancer survivors with ostomies: qualitative study.

PURPOSE: The cancer caregiving literature focuses on the early phases of survivorship, but caregiving can continue for decades when cancer creates disability. Survivors with an ostomy following colorectal cancer (CRC) have caregiving needs that may last decades. Mutuality has been identified as a relationship component that can affect caregiving. This paper discusses how mutuality may affect long-term ostomy caregiving. METHODS: We conducted semi-structured, in-depth interviews with 31 long-term CRC survivors with ostomies and their primary informal caregivers. Interviewees were members of an integrated health care delivery system in the USA. We used inductive theme analysis techniques to analyze the interviews. RESULTS: Most survivors were 71 years of age or older (67%), female (55%), and with some college education (54%). Two thirds lived with and received care from spouses. Caregiving ranged from minimal support to intimate assistance with daily ostomy care. While some survivors received caregiving far beyond what was needed, others did not receive adequate caregiving for their health care needs. Low mutuality created challenges for ostomy caregiving. CONCLUSIONS: Mutuality impacts the quality of caregiving, and this quality may change over time, depending on various factors. Emotional feedback and amplification is the proposed mechanism by which mutuality may shift over time. Survivorship care should include assessment and support of mutuality as a resource to enhance health outcomes and quality of life for survivors with long-term caregiving needs and their caregivers. Appropriate questionnaires can be identified or developed to assess mutuality over the survivorship trajectory.

Caregivers as healthcare managers: health management activities, needs, and caregiving relationships for colorectal cancer survivors with ostomies.

PURPOSE: While the burdens and rewards of cancer caregiving are well-documented, few studies describe the activities involved in cancer caregiving. We employed a social-ecological perspective to explore the work of cancer caregiving for long-term colorectal cancer (CRC) survivors with ostomies. We focused on healthcare management, defined here as the ways in which informal caregivers participate in healthcare-related activities such as managing medical appointments and information, obtaining prescriptions and supplies, and providing transportation to obtain healthcare services. METHODS: This ethnographic study included 31 dyads consisting of long-term CRC survivors (>5 years postsurgery) and their primary informal caregivers. Survivors were members of integrated healthcare delivery systems. We interviewed participants using in-depth interviews and followed a subset using ethnographic methods. Medical record data ascertained survivors' cancer and medical history. RESULTS: We classified families into a matrix of healthcare management resources (high vs. low) and survivors' healthcare needs (high vs. low). We found that patients' healthcare needs did not always correspond to their caregivers' management activities. CRC survivors with high needs had more unmet needs when caregivers and survivors differed in the level of caregiver involvement they desired or regarded as optimal. This discrepancy was particularly evident in nonmarital relationships. CONCLUSIONS: As cancer survivors age and grow in number, it becomes increasingly important to understand how informal caregivers support survivors' well-being. Framing healthcare management as a component of caregiving provides a useful perspective that could facilitate future research and interventions to support survivors, particularly those with significant sequelae from their cancer treatment.

Oncologists' attitudes toward KRAS testing: a multisite study.

Recent discoveries promise increasingly to help oncologists individually tailor anticancer therapy to their patients' molecular tumor characteristics. One such promising molecular diagnostic is Kirsten ras (KRAS) tumor mutation testing for metastatic colorectal cancer (mCRC) patients. In the current study, we examined how and why physicians adopt KRAS testing and how they subsequently utilize the information when discussing treatment strategies with patients. We conducted 34 semi-structured in-person or telephone interviews with oncologists from seven different health plans. Each interview was audiotaped, transcribed, and coded using qualitative research methods. Information and salient themes relating to the research questions were summarized for each interview. All of the oncologists in this study reported using the KRAS test at the time of the interview. Most appeared to have adopted the test rapidly, within 6 months of the publication of National Clinical Guidelines. Oncologists chose to administer the test at various time points, although the majority ordered the test at the time their patient was diagnosed with mCRC. While oncologists expressed a range of opinions about the KRAS test, there was a general consensus that the test was useful and provided benefits to mCRC patients. The rapid adoption and enthusiasm for KRAS suggests that these types of tests may be filling an important informational need for oncologists when making treatment decisions. Future research should focus on the informational needs of patients around this test and whether patients feel informed or confident with their physicians' use of these tests to determine treatment access.

Untreated peristomal skin complications among long-term colorectal cancer survivors with ostomies.

This ethnography of family caregiving explored why peristomal skin complications are common and undertreated among colorectal cancer survivors with intestinal ostomies. Data were collected through in-depth interviews with 31 cancer survivors and their family caregivers, fieldwork, structured assessments, and medical records review, and analyzed with qualitative theme and matrix analyses. Survivors who received help changing the skin barrier around their stoma had fewer obstacles to detection and treatment of peristomal skin complications. Half of the survivors received unpaid help with ostomy care, and all such help came from spouses. Married couples who collaborated in ostomy care reported that having assistance in placing the ostomy appliance helped with preventing leaks, detecting skin changes, and modifying ostomy care routines. In addition, survivors who struggled to manage ostomy care independently reported more obstacles to alleviating and seeking treatment for skin problems. Oncology nurses can improve treatment of peristomal skin problems by asking patients and caregivers about ostomy care and skin problems, examining the peristomal area, and facilitating routine checkups with a wound, ostomy, and continence nurse.

Effect of neonatal jaundice and phototherapy on the frequency of first-year outpatient visits.

OBJECTIVE: The objective of this study was to determine whether either hyperbilirubinemia or inpatient phototherapy is associated with increased subsequent outpatient visit rates, a possible effect of the "vulnerable child syndrome." METHODS: We compared 3 groups of otherwise well term and late-preterm infants who were born between 1995 and 2004 in Northern California Kaiser hospitals: group 1 never had a documented total serum bilirubin (TSB) level > or =12 mg/dL (n = 128 417); group 2 had a TSB level > or =17 and <23 mg/dL as outpatients between 48 hours and 7 days of age and did not receive inpatient phototherapy (n = 6777); and group 3 met criteria for group 2 but did receive inpatient phototherapy (n = 1765). We compared outpatient visit rates from 15 to 364 days of age adjusting for other predictors of visit rates by using Poisson and linear regression. RESULTS: The mean total number of visits between 15 and 364 days was 9.83. Compared with group 1, adjusted total first-year visit rates were slightly increased in group 2 (adjusted incidence rate ratio: 1.04 [95% confidence interval: 1.02-1.05]) and group 3 (incidence rate ratio: 1.07 [95% confidence interval: 1.05-1.10]). The increases in visit rates were greatest for visits from 15 to 59 days of age, for specialty visits, and for unspecified diagnoses. These rates correspond to adjusted increases in total first-year visits (compared with group 1) of 0.36 visits in group 2 and 0.73 visits in group 3. CONCLUSIONS: Neonatal jaundice and inpatient phototherapy are associated with only small increases in first-year outpatient visit rates, consistent with mild or infrequent contribution to the vulnerable child syndrome in this population.

Numbers needed to treat with phototherapy according to American Academy of Pediatrics guidelines.

OBJECTIVES: Our aims were to estimate the efficacy of hospital phototherapy for neonatal jaundice and the number needed to treat to prevent one infant from reaching the exchange transfusion level. METHODS: From a cohort of 281 898 infants weighing > or =2000 g born at > or =35 weeks' gestation at 12 Northern California Kaiser hospitals from 1995 to 2004, we identified 22 547 who had a "qualifying total serum bilirubin level" within 3 mg/dL of the American Academy of Pediatrics 2004 guideline phototherapy threshold. We used multiple logistic regression to estimate the efficacy of hospital phototherapy within 8 hours at preventing the bilirubin level from exceeding the 2004 guideline's exchange transfusion threshold within 48 hours. We combined this efficacy estimate with other predictors of risk to estimate the numbers needed to treat at different values of covariates. RESULTS: Of the 22 547 eligible newborns, 5251 (23%) received hospital phototherapy within 8 hours of their qualifying bilirubin level. Only 354 (1.6%) ever exceeded the guideline exchange transfusion threshold; 187 (0.8%) did so within 48 hours. Among infants who did not have a positive direct antiglobulin test, hospital phototherapy within 8 hours was highly effective (adjusted odds ratio, 0.16; 95% confidence interval, 0.07-0.34). For infants with bilirubin levels 0-0.9 mg/dL above the phototherapy threshold, the estimated number needed to treat at mean values of covariates was 222 (95% CI: 107-502) for boys and 339 (95% CI: 154-729) for girls, ranging from 10 (95% CI: 6-19) for <24-hour-old, 36-week gestation boys to 3,041 (95% CI: 888-11 096) for > or =3-day-old 41-week girls. Hospital phototherapy was less effective for infants direct antiglobulin test-positive infants (adjusted odds ratio 0.55; 95% CI: 0.21-1.45; P = 0.01 for the direct antiglobulin test x phototherapy interaction). CONCLUSIONS: While hospital phototherapy is effective, the number needed to treat according to current guidelines varies considerably across different infant subgroups.

Use of the motor performance checklist to study motor outcomes in 5-year-olds.

AIM: To report findings about the Motor Performance Checklist (MPC) for 5-year-olds, a simple 12-item instrument for assessing gross and fine motor skills, in a research study of neurodevelopmental outcomes after neonatal events. METHODS: We trained 10 examiners to use the MPC in a study of the outcomes of neonatal jaundice and dehydration in 339 5-year-old children. We compared MPC scores with those on the Wechsler Preschool and Primary Scale of Intelligence-Revised (WPPSI-R), the Beery-Buktenica Developmental Test of Visual-Motor Integration-Fourth Edition (VMI-4), and a standard neurological examination, and compared failure rates on each MPC item across examiners. Parent concerns about their child's development were addressed using the Parent Evaluation of Developmental Status (PEDS). RESULTS: Children who 'failed' the MPC had 7-10 points lower mean scores on the WPPSI-R subscales (P = 0.001), 9-10 points lower mean scores on the VMI-4 subscales (P = 0.001), and were almost twice as likely to have a 'questionable' neurological examination score (adjusted OR 1.86, 95% CI 1.00-3.53, P = 0.005). On the PEDS, only the concern about the use of arms and hands was significantly associated with MPC failure. We found significant sex differences on four of the 12 MPC items. We also found differences in failure rates by different examiners. CONCLUSIONS: MPC scores correlated with other measures of neurodevelopment. Because of different failure rates across examiners, examiner terms need to be included if it is used in research studies.

Risk factors for severe hyperbilirubinemia among infants with borderline bilirubin levels: a nested case-control study.

OBJECTIVE: To estimate the effect of phototherapy and other predictors on the risk of total serum bilirubin (TSB) >or= 25 mg/dL in infants with a TSB of 17 to 22.9 mg/dL at age >or= 48 hours. STUDY DESIGN: From a cohort of 285295 infants >or= 34 weeks gestation and >or= 2000 g born between 1995 and 2004 in northern California Kaiser hospitals, we identified 17986 with a TSB of 17 to 22.9 mg/dL at age >or= 48 hours. All infants exhibiting a TSB >or= 25 mg/dL were selected as cases for the study. Four randomly selected controls were matched to each case based on the difference between their qualifying TSB and the American Academy of Pediatrics' phototherapy threshold. RESULTS: A total of 62 cases were identified (0.4%). Six of these (10%) received inpatient phototherapy within 8 hours, along with 101 controls (41%) (adjusted odds ratio [AOR] 0.15; 95% confidence interval [CI] 0.06 to 0.40). Cases more often had lower gestational age (AOR 3.24; 95% CI 1.24 to 8.47 for 38 to 39 weeks and AOR = 3.70; 95% CI 0.61 to 22.4 for 34 to 37 weeks compared with >or= 40-week infants), bruising, (AOR 2.52; 95% CI 1.16 to 5.50), exclusive breast-feeding (AOR 2.09; 95% CI 1.05 to 4.03), and TSB increase of >or= 6 mg/dL/day (AOR 2.39; 95% CI 1.18 to 4.85). CONCLUSIONS: Phototherapy was 85% effective in preventing TSB >or= 25 mg/dL. The strongest predictors of TSB >or= 25 mg/dL were gestational age, bruising, family history, and rapid rise in TSB.

Five-year neurodevelopmental outcome of neonatal dehydration.

OBJECTIVE: To determine the long-term outcome of neonatal dehydration. STUDY DESIGN: We identified 182 newborns who were rehospitalized with dehydration (weight loss > or =12% of birth weight and/or serum sodium > or =150 mEq/L) and 419 randomly selected controls from a cohort of 106,627 term and near-term infants with birth weight > or =2000 g born between 1995 and 1998 in northern California Kaiser Permanente hospitals. Outcomes data were obtained from electronic records, interviews, questionnaire responses, and neurodevelopmental evaluations performed in a masked fashion. RESULTS: Follow-up data to age at least 2 years were available for 173 of 182 children with a history of dehydration (95%) and 372 of 419 controls (89%) and included formal evaluation at a mean age (+/-standard deviation) of 5.1 +/- 0.12 years for 106 children (58%) and 168 children (40%), respectively. None of the cases developed shock, gangrene, or respiratory failure. Neither crude nor adjusted scores on cognitive tests differed significantly between groups. There was no significant difference between groups in the proportion of children with abnormal neurologic examinations or neurologic diagnoses. Frequencies of parental concerns and reported behavior problems also were not significantly different in the 2 groups. CONCLUSIONS: Neonatal dehydration in this managed care setting was not associated with adverse neurodevelopmental outcomes in infants born at or near term.

Outcomes among newborns with total serum bilirubin levels of 25 mg per deciliter or more.

BACKGROUND: The neurodevelopmental risks associated with high total serum bilirubin levels in newborns are not well defined. METHODS: We identified 140 infants with neonatal total serum bilirubin levels of at least 25 mg per deciliter (428 micromol per liter) and 419 randomly selected controls from a cohort of 106,627 term and near-term infants born from 1995 through 1998 in Kaiser Permanente hospitals in northern California. Data on outcomes were obtained from electronic records, interviews, responses to questionnaires, and neurodevelopmental evaluations that had been performed in a blinded fashion. RESULTS: Peak bilirubin levels were between 25 and 29.9 mg per deciliter (511 micromol per liter) in 130 of the newborns with hyperbilirubinemia and 30 mg per deciliter (513 micromol per liter) or more in 10 newborns; treatment involved phototherapy in 136 cases and exchange transfusion in 5. Follow-up data to the age of at least two years were available for 132 of 140 children with a history of hyperbilirubinemia (94 percent) and 372 of 419 controls (89 percent) and included formal evaluation at a mean (+/-SD) age of 5.1+/-0.12 years for 82 children (59 percent) and 168 children (40 percent), respectively. There were no cases of kernicterus. Neither crude nor adjusted scores on cognitive tests differed significantly between the two groups; on most tests, 95 percent confidence intervals excluded a 3-point (0.2 SD) decrease in adjusted scores in the hyperbilirubinemia group. There was no significant difference between groups in the proportion of children with abnormal neurologic findings on physical examination or with documented diagnoses of neurologic abnormalities. Fourteen of the children with hyperbilirubinemia (17 percent) had "questionable" or abnormal findings on neurologic examination, as compared with 48 controls (29 percent; P=0.05; adjusted odds ratio, 0.47; 95 percent confidence interval, 0.23 to 0.98; P=0.04). The frequencies of parental concern and reported behavioral problems also were not significantly different between the two groups. Within the hyperbilirubinemia group, those with positive direct antiglobulin tests had lower scores on cognitive testing but not more neurologic or behavioral problems. CONCLUSIONS: When treated with phototherapy or exchange transfusion, total serum bilirubin levels in the range included in this study were not associated with adverse neurodevelopmental outcomes in infants born at or near term.

Combining clinical risk factors with serum bilirubin levels to predict hyperbilirubinemia in newborns.

OBJECTIVES: (1) To validate a previously reported risk index for predicting total serum bilirubin (TSB) levels of 25 mg/dL (428 micromol/L) or higher; (2) to combine a subset of this index with TSB levels measured at less than 48 hours to predict subsequent TSB levels of 20 mg/dL (342 micromol/L) or higher. DESIGN: Nested case-control study using electronic and paper records (study 1). Retrospective cohort study using electronic records only (study 2). SETTING: Northern California Kaiser Permanente hospitals. PATIENTS: Subjects for both studies were newborns weighing 2000 g or more and of 36 weeks' or more gestation. The validation study included 67 cases born 1997-1998 who developed TSB levels of 25 mg/dL or higher at less than 30 days and 208 randomly selected control subjects. Subjects for study 2 were 5706 newborns who both were discharged from the hospital and had a TSB level measured at less than 48 hours. RESULTS: The risk index performed similarly in the validation group, born in 1997-1998, and the derivation group, born in 1995-1996 (area under the receiver operating characteristic curve = 0.83 vs 0.84). Of the 5706 newborns with TSB levels measured before 48 hours, 270 (4.7%) developed a TSB level of 20 mg/dL or higher. Of these, 254 (94%) had a TSB level at the 75th percentile or higher at less than 48 hours. The risk index improved prediction over the TSB level alone, largely owing to the effect of gestational age. For example, for those with a TSB level at the 95th percentile or higher at less than 48 hours, the risk increased from 9% for newborns born at 40 weeks' or more gestation to 42% for those born at 36 weeks. CONCLUSION: Clinical risk factors significantly improve prediction of subsequent hyperbilirubinemia compared with early TSB levels alone, especially in those with early TSB levels above the 75th percentile.

HIV care: continuing medical education and consultation needs of nurses, physicians, and pharmacists.

This article explores the impact of provider characteristics on their HIV-related continuing medical education (CE) attendance, consultation needs, satisfaction with skills, and willingness to provide care. A total of 731 users (52% physicians, 26% nurses, 11% pharmacists, and 10% nurse practitioners and physician assistants) of an HIV consultation were surveyed by mail (76% response). Significant differences in provider variables were found to be related to HIV experience and profession. Experienced providers reported more CE, more satisfaction with skills, lower consultation needs, more consultations sought, and more willingness to take new patients than other providers. "Unwillingness" was commonly explained by concerns over quality of care or staying up-to-date. Relative to physicians, nurses had more CE hours, were more dissatisfied with their skills, and had greater consultation needs. Although all providers had high consultation or CE needs in some areas, accessibility to such programs is particularly important for low-volume providers.

Infants with bilirubin levels of 30 mg/dL or more in a large managed care organization.

OBJECTIVE: To describe the incidence, etiology, treatment, and outcome of newborns with total serum bilirubin (TSB) levels >or=30 mg/dL (513 micro mol/L). DESIGN: Population-based case series. SETTING: Eleven Northern California Kaiser Permanente Medical Care Program hospitals and 1 affiliated hospital. PATIENTS: Eleven infants with TSB levels of >or=30 mg/dL in the first 30 days after birth, identified using computer databases from a cohort of 111,009 infants born 1995-1998. OUTCOME MEASURES: Clinical data from the birth hospitalization, rehospitalization, and outpatient visits in all infants; psychometric testing at age 5 (N = 3), neurologic examinations by child neurologists at age 5 (N = 3), or primary care providers (N = 7; mean age: 2.2 years); Parent Evaluation of Developmental Status (N = 8; mean age: 4.2 years). RESULTS: Maximum TSB levels of the 11 infants ranged from 30.7 to 45.5 mg/dL (525 micro mol/L to 778 micro mol/L; mean: 34.9 mg/dL [597 micro mol/L]). Four were born at 35 to 36 weeks gestation, and 7 were exclusively breastfed. Two had apparent isoimmunization; the etiology for the other 9 remained obscure, although only 4 were tested for glucose-6-phosphate dehydrogenase deficiency and 1 was bacteremic. None had acute neurologic symptoms. All received phototherapy and 5 received exchange transfusions. One infant died of sudden infant death syndrome; there was no kernicterus at autopsy. Two were lost to follow-up but were neurologically normal when last seen for checkups at 18 and 43 months. One child was receiving speech therapy at age 3. There were no significant parental concerns or abnormalities in the other children. CONCLUSIONS: In this setting, TSB levels >or=30 mg/dL were rare and generally unaccompanied by acute symptoms. Although we did not observe serious neurodevelopmental sequelae in this small sample, additional studies are required to quantify the known, significant risk of kernicterus in infants with very high TSB levels.

Jaundice noted in the first 24 hours after birth in a managed care organization.

OBJECTIVE: To investigate the significance of jaundice noted in the first 24 hours after birth in a community setting. DESIGN: Supplementary analyses of a nested case-control study. SETTING: Northern California Kaiser Permanente Medical Care Program. PATIENTS: Six hundred thirty-one randomly selected newborns (controls) and 140 cases with total serum bilirubin levels of 25 mg/dL (428 micro mol/L) or higher from a cohort of 105 384 newborns of at least 2000 g birth weight and at least 36 weeks' gestational age, born between January 1, 1995, and December 31, 1998. MAIN OUTCOME MEASURES: Notations of jaundice in the medical record, timing and results of bilirubin testing, use of phototherapy, and development of bilirubin levels of 25 mg/dL or higher. RESULTS: Among the controls, the cumulative probability of a notation of jaundice (corrected for early hospital discharge using survival analysis) was 2.8% within 18 hours and 6.7% within 24 hours. In these newborns, cumulative proportions that had bilirubin levels measured were 38% within 12 hours and 43% within 24 hours of when jaundice was first noted. About 40% of bilirubin levels measured within 24 hours were above the estimated 95th percentile for age. Compared with newborns not noted to be jaundiced on the first day, newborns noted to be jaundiced within 24 hours were more likely to receive phototherapy (18.9% vs 1.7%; relative risk, 10.1; 95% confidence interval, 4.2-24.4) and to develop a bilirubin level of 25 mg/dL or higher (odds ratio, 2.9; 95% confidence interval, 1.6-5.2), but the absolute risk increase for total serum bilirubin levels of 25 mg/dL or higher was 0.2%. CONCLUSION: Jaundice noted in the medical record in the first 24 hours after birth was uncommon and often clinically significant in this setting, but other factors also need to be considered in determining its importance.