A randomized prospective trial of an ostomy telehealth intervention for cancer survivors.

BACKGROUND: Cancer survivors with ostomies face complex challenges. This study compared the Ostomy Self-Management Telehealth program (OSMT) versus attention control usual care (UC). METHODS: Three academic centers randomized participants. OSMT group sessions were led by ostomy nurses and peer ostomates (three for ostomates-only, one for support persons, and one review session for both). Surveys at baseline, OSMT completion, and 6 months were primary outcome patient activation (PAM), self-efficacy (SE), City of Hope quality of life-Ostomy (COH-O), and Hospital Anxiety and Depression Scale (HADS). Surveys were scored per guidelines for those completing at least two surveys. Linear mixed effects models were used to select potential covariates for the final model and to test the impact of OSMT within each timeframe. RESULTS: A total of 90 OSMT and 101 UC fulfilled analysis criteria. Arms were well-matched but types of tumors were unevenly distributed (p = .023). The OSMT arm had a nonsignificant improvement in PAM (confidence interval [CI], -3.65 to 5.3]; 4.0 vs. 2.9) at 6 months. There were no significant differences in other surveys. There was a significant OSMT benefit for urinary tumors (four SE domains). Higher OSMT session attendance was associated with post-session improvements in five SE domains (p < .05), two COH-O domains (p < .05), and HADS anxiety (p = .01). At 6 months, there remained improvements in one SE domain (p < .05), one COH-O domain (p < .05), and HADS anxiety (p < .01). CONCLUSIONS: No clear benefit was seen for the OSMT intervention, although there may be an advantage based on type of tumor. Benefit with greater session attendance was also encouraging. PLAIN LANGUAGE SUMMARY: Cancer patients with ostomies have many challenges. We tested a telehealth curriculum compared to usual care. There are indications of benefit for the program for those that attend more sessions and those with urostomies.

Validation of the PAM-13 instrument in the Hungarian general population 40 years old and above.

BACKGROUND: Patient activation comprises the skills, knowledge and motivation necessary for patients' effective contribution to their care. We adapted and validated the 13-item Patient Activation Measure (PAM-13) in the ≥ 40 years old Hungarian general population. METHODS: A cross-sectional web survey was conducted among 900 respondents selected from an online panel via quota sampling. After 10 days, the survey was repeated on 100 respondents. The distribution, internal consistency, test-retest reliability, factor structure, convergent, discriminant and known-groups validity of PAM-13 were assessed according to the COSMIN guidelines. RESULTS: The sample comprised 779 respondents. Mean (± SD) age was 60.4 ± 10.6 years, 54% were female and 67% had chronic illness. Mean (± SD) PAM-13 score was 60.6 ± 10.0. We found good internal consistency (Cronbach alpha: 0.77), moderate test-retest reliability (ICC: 0.62; n = 75), a single-factor structure and good content validity: PAM-13 showed moderate correlation with the eHealth Literacy Scale (r = 0.40), and no correlation with age (r = 0.02), education (r = 0.04) or income (ρ = 0.04). Higher PAM-13 scores were associated with fewer lifestyle risks (p < 0.001), more frequent health information seeking (p < 0.001), participation in patient education (p = 0.018) and various online health-related behaviours. When controlling for health literacy, sociodemographic factors and health status, the association of higher PAM-13 scores with overall fewer lifestyle risks, normal body mass index, physical activity and adequate diet remained significant. Similar properties were observed in the subgroup of participants with chronic morbidity, but not in the age group 65+. CONCLUSION: PAM-13 demonstrated good validity in the general population. Its properties in clinical populations and the elderly as well as responsiveness to interventions warrant further research.

Patient activation and treatment decision-making in the context of cancer: examining the contribution of informal caregivers' involvement.

PURPOSE: The present work investigated the relationship between patient activation, treatment decision-making, and adherence to the prescribed treatment regimen. Given the role of informal caregivers in patient-reported outcomes, it was additionally assessed whether caregiver involvement acted as a moderator of this relationship. METHODS: Survey data collected from 504 cancer survivors were utilized. Structural equation modeling (SEM) controlling for covariates was used to examine the relationship between patient activation measure (PAM), caregiver involvement, and the identified outcomes. Moderator analysis was conducted using multiple group SEM. RESULTS: Patient activation was significantly associated with treatment planning being reflective of survivors' goals and values (p < 0.001); adherence to treatment (p = 0.011); and satisfaction (p < 0.001). Caregiver's involvement significantly moderated the association between activation and adherence to treatment. CONCLUSIONS: Patient activation was positively associated with all three selected outcomes. However, for cancer survivors reporting low rates of caregiver's involvement, patient activation was not associated with treatment adherence. Research is needed to test and deliver self-management interventions inclusive of informal caregivers. IMPLICATIONS FOR CANCER SURVIVORS: Findings supported the need not only to monitor and sustain patient activation across the cancer continuum, but also to assume a dyadic perspective when designing self-management interventions in cancer survivorship.

Morbidity associated with the use of Foley balloon for cervical ripening in women with prior cesarean delivery.

OBJECTIVE: We evaluated the morbidity of Foley balloon for cervical ripening in comparison to oxytocin alone in women with a prior cesarean delivery. STUDY DESIGN: A four-hospital retrospective review of all women with viable singleton pregnancies and history of a single prior cesarean delivery presenting for cervical ripening between 1994 and 2015. Exposure groups were either Foley balloon or oxytocin, at the treating physician's discretion. The primary outcome was defined as maternal morbidity, evaluated by a composite that included hemorrhage, and/or uterine infection, and/or uterine rupture. We defined two secondary outcomes: neonatal morbidity, and vaginal delivery rate. Neonatal morbidity was evaluated by a composite that included five-minute APGAR score <7 and/or NICU admission. We adjusted results for potential confounding variables, including hospital site, maternal age and race, initial cervical dilation, and gestational age at delivery. RESULTS: We identified 688 patients who received ripening, 276 by Foley balloon and 412 by oxytocin. There was no significant difference in the primary outcome of maternal morbidity between groups: 38 (13.8%) in the Foley balloon group and 79 (19.2%) in the oxytocin group (aOR 1.43; 95% CI, 0.90-2.27). There was no significant difference in the secondary outcome of neonatal morbidity: 31 (11.3%) in the Foley balloon group and 51 (12.4%) in the oxytocin group (aOR 1.02; 95% CI, 0.57-1.80). The rate of vaginal delivery was significantly less in the Foley balloon group compared to the oxytocin group: 56.2% vs 64.1%, p = .037. CONCLUSION: When cervical ripening with either Foley balloon or oxytocin was utilized at the physician's discretion in women with prior cesarean, there was no identified difference in maternal and neonatal morbidity, but the rate of successful vaginal delivery was lower.

Placental endothelin-converting enzyme-1 is decreased in preeclampsia.

Endothelin-converting enzyme-1(ECE-1) is a key regulatory enzyme in the processing of endothelin-1 (ET-1). We quantified and localized ECE-1 in normal and preeclamptic placentas. Normal (n=6) and preeclamptic (n=6) placentas were serially sectioned for immunofluorescence (IF). Cell type specific markers identified endothelial, trophoblast, macrophage, smooth muscle, and fibroblast cells. Quantitative analyses were performed by western blot and ELISA. IF identified ECE-1 expression within the stroma and villous space. Cellular localization of ECE-1 was limited to endothelial membranes. There was significantly less ECE-1 in preeclamptic placentas, suggesting ECE-1 is important for proper regulation of ET-1 within the placenta.

The Association between Advanced Maternal Age and Diagnosis of Small for Gestational Age.

OBJECTIVES: To identify whether advanced maternal age (AMA), defined as age ≥35 years old, is independently associated with small for gestational age (SGA). STUDY DESIGN: This was a retrospective cohort of births from the National Vital Statistics System in the United States from 2009 to 2013. Women were categorized based on four age groups at the time of delivery: 20 to 29, 30 to 34, 35 to 39, and ≥40 years old. The primary outcome of SGA < 10th and SGA < 5th percentiles was compared between the four groups using both univariable and multivariable analyses to determine whether maternal age was associated with SGA independent of parity. RESULTS: A total of 17,031,005 births were eligible for analysis, with 2,705,501 births to AMA women. In multivariable analyses, maternal age of 30 to 34, compared with 20 to 29, was associated with lower rates of SGA < 10th and <5th percentiles (adjusted odds ratio [aOR] = 0.95; 95% confidence interval [CI]: 0.95-0.96 and aOR = 0.97; 95% CI: 0.96-0.98, respectively). The AMA of 35 to 39, compared with 20 to 29, was associated with lower rates of SGA < 10th percentile and unchanged rates of SGA < 5th percentile (aOR = 0.97; 95% CI: 0.96-0.98 and aOR = 1; 95% CI: 0.99-1.01, respectively). In contrast, AMA of ≥40, compared with age 20 to 29, was associated with higher rates of both SGA < 10th and <5th percentiles (aOR = 1.06; 95% CI: 1.04-1.07 and aOR = 1.14; 95% CI: 1.12-1.16, respectively). A significant association was found between maternal age and parity toward the risk of SGA (p < 0.001). Nulliparous women ≥30 years old but not multiparous women had higher rates of SGA < 10th and SGA < 5th percentiles compared with nulliparous women in the age group of 20 to 29. In contrast, both nulliparous and multiparous women age ≥40 years old had an increased risk for SGA < 5th percentile compared with all women in the age group of 20 to 29. CONCLUSION: Nulliparous women aged 30 years and older have higher risk of SGA < 10th and SGA < 5th percentiles compared with nulliparous women age 20 to 29. In contrast, both nulliparous and multiparous women age 40 years and older have an increased risk of SGA < 5th percentile compared with all women in the age group of 20 to 29.

Effect of a Hospital-Initiated Program Combining Transitional Care and Long-term Self-management Support on Outcomes of Patients Hospitalized With Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial.

Importance: Patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbations have high rehospitalization rates and reduced quality of life. Objective: To evaluate whether a hospital-initiated program that combined transition and long-term self-management support for patients hospitalized due to COPD and their family caregivers can improve outcomes. Design, Setting, and Participants: Single-site randomized clinical trial conducted in Baltimore, Maryland, with 240 participants. Participants were patients hospitalized due to COPD, randomized to intervention or usual care, and followed up for 6 months after hospital discharge. Enrollment occurred from March 2015 to May 2016; follow-up ended in December 2016. Interventions: The intervention (n = 120) involved a comprehensive 3-month program to help patients and their family caregivers with long-term self-management of COPD. It was delivered by nurses with special training on supporting patients with COPD using standardized tools. Usual care (n = 120) included transition support for 30 days after discharge to ensure adherence to discharge plan and connection to outpatient care. Main Outcomes and Measures: The primary outcome was number of COPD-related acute care events (hospitalizations and emergency department visits) per participant at 6 months. The co-primary outcome was change in participants' health-related quality of life measured by the St George's Respiratory Questionnaire (SGRQ) at 6 months after discharge (score, 0 [best] to 100 [worst]; 4-point difference is clinically meaningful). Results: Among 240 patients who were randomized (mean [SD] age, 64.9 [9.8] years; 61.7% women), 203 (85%) completed the study. The mean (SD) baseline SGRQ score was 62.3 (18.8) in the intervention group and 63.6 (17.4) in the usual care group. The mean number of COPD-related acute care events per participant at 6 months was 1.40 (95% CI, 1.01-1.79) in the intervention group vs 0.72 (95% CI, 0.45-0.97) in the usual care group (difference, 0.68 [95% CI, 0.22-1.15]; P = .004). The mean change in participants' SGRQ total score at 6 months was 2.81 in the intervention group and -2.69 in the usual care group (adjusted difference, 5.18 [95% CI, -2.15 to 12.51]; P = .11). During the study period, there were 15 deaths (intervention: 8; usual care: 7) and 339 hospitalizations (intervention: 202; usual care: 137). Conclusions and Relevance: In a single-site randomized clinical trial of patients hospitalized due to COPD, a 3-month program that combined transition and long-term self-management support resulted in significantly greater COPD-related hospitalizations and emergency department visits, without improvement in quality of life. Further research is needed to determine reasons for this unanticipated finding. Trial Registration: ClinicalTrials.gov Identifier: NCT02036294.

The Impact of Fetal Anomalies on Contemporary Labor Patterns.

OBJECTIVE: To compare labor patterns in pregnancies affected by fetal anomalies to low-risk singletons. STUDY DESIGN: Labor data from the Consortium on Safe Labor, a multicenter retrospective study from 19 U.S. hospitals, including 98,674 low-risk singletons compared with 6,343 pregnancies with fetal anomalies were analyzed. Repeated-measures analysis constructed mean labor curves by parity, gestational age, and presence of fetal anomaly in women who reached full dilation. Interval-censored regression analysis adjusted for covariables was used to determine the median traverse times for labor progression. RESULTS: Labor curves for all groups indicated slower labor progress for patients with fetal anomalies. The most significant trends in median traverse times were observed in the preterm nulliparous and term multiparous groups. The median traverse times from 4 cm to complete dilation in the preterm nulliparous control versus anomaly groups were 5.0 and 5.4 hours (p < 0.0001). CONCLUSION: Labor proceeds at a slower rate in pregnancies affected by anomalies.

Increasing the Use of Comparative Quality Information in Maternity Care: Results From a Randomized Controlled Trial.

This randomized controlled trial tested an intervention to increase uptake of hospital-level maternity care quality reports among 245 pregnant women in North Carolina (123 treatment; 122 control). The intervention included three enhancements to the quality report offered to the control: (a) biweekly text messages or e-mails directing women to the website, (b) videos and materials describing the relevance of quality measures to pregnant women's interests, and (c) tools to support discussions with clinicians. Compared with controls, intervention participants were significantly more likely to visit the website and report adopting behaviors to inform care, such as thinking through preferences, talking with their doctor, or creating a birth plan. Reports designed to put quality information into the larger context of what consumers want and need to know, along with targeted and timely communications, can increase consumer use of quality information and prompt them to talk with providers about care preferences and evidence-based practices.

Testing a Personal Narrative for Persuading People to Value and Use Comparative Physician Quality of Care Information: An Experimental Study.

Objective: This study tests whether a personal narrative can persuade people to value comparative data on physician quality. Method: We conducted an online experiment with 850 adults. One group viewed a cartoon narrative on physician quality variation, another saw text on physician quality variation, and there was a control group. Study participants hypothetically selected a physician from a display of four physicians. The top-quality physician was furthest away and most expensive. We conducted multivariate models examining the relationship between experimental group and choice of the top-quality physician. Results: There was no overall relationship between narrative or text information and choice of the highest quality physician. Among higher numerate participants, however, those who viewed the narrative had odds 2.7 times higher of selecting the top-quality physician compared with the control group. Discussion: Personal narratives can persuade higher numerate people to consider quality when selecting physicians.

Effect of a Program Combining Transitional Care and Long-term Self-management Support on Outcomes of Hospitalized Patients With Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial.

Importance: Patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbations have high rehospitalization rates and reduced quality of life. Objective: To evaluate a hospital-initiated program that combined transition and long-term self-management support for patients hospitalized due to COPD and their family caregivers. Design, Setting, and Participants: This single-site randomized clinical trial was conducted in Baltimore, Maryland, with 240 participants. Participants were patients hospitalized due to COPD, randomized to intervention or usual care, and followed up for 6 months after hospital discharge. Enrollment occurred from March 2015 to May 2016; follow-up ended in December 2016. Interventions: The intervention (n = 120) was a comprehensive 3-month program to help patients and their family caregivers with long-term self-management of COPD. It was delivered by COPD nurses (nurses with special training on supporting patients with COPD using standardized tools). Usual care (n = 120) included transition support for 30 days after discharge to ensure adherence to discharge plan and connection to outpatient care. Main Outcomes and Measures: The primary outcome was number of COPD-related acute care events (hospitalizations and emergency department visits) per participant at 6 months. The co-primary outcome was change in participants' health-related quality of life measured by the St George's Respiratory Questionnaire (SGRQ) at 6 months after discharge (score, 0 [best] to 100 [worst]; 4-point difference is clinically meaningful). Results: Among 240 patients who were randomized (mean [SD] age, 64.9 [9.8] years; females, 61.7%), 203 (85%) completed the study. The mean (SD) baseline SGRQ score was 63.1 (19.9) in the intervention group and 62.6 (19.3) in the usual care group. The mean number of COPD-related acute care events per participant at 6 months was 0.72 (95% CI, 0.45-0.97) in the intervention group vs 1.40 (95% CI, 1.01-1.79) in the usual care group (difference, 0.68 [95% CI, 0.22 to 1.15]; P = .004). The mean change in participants' SGRQ total score at 6 months was -1.53 in the intervention and +5.44 in the usual care group (adjusted difference, -6.69 [95% CI, -12.97 to -0.40]; P = .04). During the study period, there were 15 deaths (intervention: 7; usual care: 8) and 337 hospitalizations (intervention: 135; usual care: 202). Conclusions and Relevance: In a single-site randomized clinical trial of patients hospitalized due to COPD, a 3-month program that combined transition and long-term self-management support resulted in significantly fewer COPD-related hospitalizations and emergency department visits and better health-related quality of life at 6 months after discharge. Further research is needed to evaluate this intervention in other settings. Trial Registration: ClinicalTrials.gov Identifier: NCT02036294.

Patient Activation Changes as a Potential Signal for Changes in Health Care Costs: Cohort Study of US High-Cost Patients.

BACKGROUND: Programs to improve quality of care and lower costs for the highest utilizers of health services are proliferating, yet such programs have difficulty demonstrating cost savings. OBJECTIVE: In this study, we explore the degree to which changes in Patient Activation Measure (PAM) levels predict health care costs among high-risk patients. PARTICIPANTS: De-identified claims, demographic data, and serial PAM scores were analyzed on 2155 patients from multiple medical groups engaged in an existing Center for Medicare and Medicaid Innovation-funded intervention over 3 years designed to activate and improve care coordination for high-risk patients. DESIGN: In this prospective cohort study, four levels of PAM (from low to high) were used as the main predictor variable. We fit mixed linear models for log10 of allowed charges in follow-up periods in relation to change in PAM, controlling for baseline PAM, baseline costs, age, sex, income, and baseline risk score. MAIN MEASURES: Total allowed charges were derived from claims data for the cohort. PAM scores were from a separate database managed by the local practices. KEY RESULTS: A single PAM level increase was associated with 8.3% lower follow-up costs (95% confidence interval 2.5-13.2%). CONCLUSIONS: These findings contribute to a growing evidence base that the change in PAM score could serve as an early signal indicating the impact of interventions designed for high-cost, high-needs patients.

SMFM Consult Series #46: Evaluation and management of polyhydramnios.

Polyhydramnios, or hydramnios, is an abnormal increase in the volume of amniotic fluid. Identification of polyhydramnios should prompt a search for an underlying etiology. Although most cases of mild polyhydramnios are idiopathic, the 2 most common pathologic causes are maternal diabetes mellitus and fetal anomalies, some of which are associated with genetic syndromes. Other causes of polyhydramnios include congenital infection and alloimmunization. The purpose of this document is to provide guidance on the evaluation and management of polyhydramnios. The following are Society for Maternal-Fetal Medicine recommendations: (1) we suggest that polyhydramnios in singleton pregnancies be defined as either a deepest vertical pocket of ≥8 cm or an amniotic fluid index of ≥24 cm (GRADE 2C); (2) we recommend that amnioreduction be considered only for the indication of severe maternal discomfort, dyspnea, or both in the setting of severe polyhydramnios (GRADE 1C); (3) we recommend that indomethacin should not be used for the sole purpose of decreasing amniotic fluid in the setting of polyhydramnios (GRADE 1B); (4) we suggest that antenatal fetal surveillance is not required for the sole indication of mild idiopathic polyhydramnios (GRADE 2C); (5) we recommend that labor should be allowed to occur spontaneously at term for women with mild idiopathic polyhydramnios; that induction, if planned, should not occur at <39 weeks of gestation in the absence of other indications; and that mode of delivery should be determined based on usual obstetric indications (GRADE 1C); and (6) we recommend that women with severe polyhydramnios deliver at a tertiary center due to the significant possibility that fetal anomalies may be present (GRADE 1C).

New Insights in Peripartum Cardiomyopathy.

Significant progress in understanding the pathophysiology of peripartum cardiomyopathy, especially hormonal and genetic mechanisms, has been made. Specific criteria should be used for diagnosis, but the disease remains a diagnosis of exclusion. Both long-term and recurrent pregnancy prognoses depend on recovery of cardiac function. Data from large registries and randomized controlled trials of evidence-based therapeutics hold promise for future improved clinical outcomes.

Does the Race/Ethnicity or Gender of a Physician's Name Impact Patient Selection of the Physician?

This study's objective was to examine the extent to which individuals exhibit a preference for physicians based upon the race/ethnicity and gender of a physician's name. We conducted an online survey of 915 adults, who viewed a comparative display of four physicians' quality performance. We randomized the name of one physician, whose quality performance was equal to that of one physician and better than two other physicians, to be either typically African American male, African American female, white male, white female, or Middle Eastern (gender ambiguous). In regression models, participants more frequently selected the physician with the randomized name when displayed with a white male name, compared to when presented with an African American male, African American female, or Middle Eastern name (ORs ranging from .59 to .64). White and male study participants exhibited this pattern, while racial/ethnic minority participants did not. If the hypothetical choice bias observed here translates to people's actual selection of physicians, it could be a contributing factor for why women and racial/ethnic minority physicians have lower incomes than white male physicians.

Antenatal Treatment with Intravenous Immunoglobulin to Prevent Gestational Alloimmune Liver Disease: Comparative Effectiveness of 14-Week versus 18-Week Initiation.

BACKGROUND: Antenatal therapy with high-dose intravenous immunoglobulin (IVIG) may prevent gestational alloimmune liver disease (GALD). OBJECTIVE: The objective of this study was to determine the effectiveness of this approach in a large cohort of women at risk for poor pregnancy outcome due to GALD. METHODS: Women with a history of affected offspring were provided antenatal IVIG treatment and data were acquired prospectively from 1997 to 2015. The outcomes of treated pregnancies were compared to those of untreated pregnancies, and the effectiveness of starting at 14 weeks was compared to that of starting at 18 weeks. RESULTS: A total of 188 treated pregnancies in 151 women were analyzed. Only 30% (n = 105) of untreated gestations resulted in healthy offspring as compared to 94% (n = 177) of treated pregnancies (p < 0.0001). Treated gestations of both the 14-week (n = 108) and the 18-week (n = 80) start cohort showed a decreased rate of fetal loss relative to untreated gestations (p < 0.0001). Equivalent outcomes were recorded in the 18-week versus the 14-week start cohort (p > 0.05). Few adverse events or complications of antenatal therapy were recorded. CONCLUSION: Antenatal therapy with high-dose IVIG initiated at either 18 or 14 gestational weeks effectively prevents poor outcome of pregnancies at risk for GALD.

Growth restriction: identifying fetuses at risk.

PURPOSE: Examine risks of intrauterine growth restriction (IUGR) and composite perinatal outcomes with estimated fetal weights (EFW) 10-20th%, and compare outcomes using umbilical artery Doppler (UAD). MATERIALS AND METHODS: Retrospective, cohort evaluating ultrasound (US) EFW 10-20th%, between 2002 and 2012. Cases were identified with EFW % 10-20. Controls, EFW >20th% were obtained for each case, matched by gestational age, and US date. Unadjusted and adjusted logistic regression was used for outcomes. RESULTS: Seven hundred and sixty-seven cases met criteria with matched controls. Fetuses having EFW 10-20th% (GA 33.6 ± 3.7 weeks) had increased IUGR on follow up ultrasound (OR 26.5[10.2-68.7], p < .01), small for gestational age (SGA) (OR 9.2 [6.9-12.3], p < .01), neonatal intensive care unit (NICU) admissions (OR 2.4 [1.6-3.6], p < .01), and composite perinatal morbidity (OR 7.8 [6.0-10.1], p < .01) on adjusted analyses. Abnormal UAD in cases had greater rates of 5 min Apgar <7, NICU admission and composite morbidity (p < .05). CONCLUSIONS: Pregnancies with EFW 10-20th% at the time of initial US are at increased risk for developing IUGR and being SGA at birth, with more NICU admissions and composite perinatal outcomes; abnormal UAD evaluation in cases conveyed further increase in outcomes.