Purpose Use of electronic patient-reported outcome (ePRO) tools in routine oncology practice can be challenging despite evidence showing they can improve survival, improve patient and practitioner satisfaction, and reduce medical resource utilization. Head and neck cancer (HNC) patients receiving radiation therapy (RT) may be a group that would particularly benefit from interventions focused on early symptom management. Methods Patients undergoing definitive RT for HNC were enrolled in a feasibility study and received ePRO surveys integrated within the electronic medical record (EMR) on a weekly basis during RT. After completion of each ePRO survey, a radiation oncology registered nurse documented the findings and subsequent interventions within the EMR. Results Thirty-four patients with HNC who received curative RT at a single center were enrolled. The total number of surveys completed was 194 with a median of 7 surveys per patient (range 1-8). There was a total of 887 individual abnormal findings reported on the ePROs, and the authors found that all 887 had a corresponding documented intervention. Post-treatment practitioner questionnaires highlighted that ePROs were felt to be helpful for the care team in providing care to HNC patients. Conclusion For patients with HNC receiving RT, ePROs can be effectively utilized to address patient symptoms within an integrated health care system. Creating an infrastructure for the use of ePROs integrated within the EMR in routine care requires an approach that accounts for local workflows and buy-in from patients and the entire care team.

e13612 Background: Use of electronic Patient Reported Outcomes (ePRO) tools in the routine care of cancer patients remains challenging despite data showing that they can improve resource utilization and patient outcomes. Patients with head and neck cancer during intensive therapy with radiation therapy (RT) may particularly benefit from interventions focused on early symptom management. Methods: 34 patients with head and neck cancer were enrolled in an implementation study and received ePROs integrated within the electronic medical record (EMR) weekly during radiation therapy (RT) within a large integrated health care delivery system. ePROs consisted of the FACT G7 and FACT-HN. After completion of each survey on the patient portal, a radiation oncology RN documented any abnormal findings and subsequent interventions using a standardized format within the EMR. If patients did not have access to the patient portal or had language barriers, they could complete ePROs with a translator by phone or video. Results: Between January and December of 2021, 34 patients with head and neck cancer receiving curative RT were enrolled. The median age 65 years (range 46-84). 74% of patients were male. 59% were white, 26% Asian/PI, 5% Black, and 5% Hispanic. The most common primary cancer sites were: oropharynx (32%), nasopharynx (24%), larynx (18%), oral cavity (9%). 65% of patients received concurrent chemotherapy with RT and 35% received RT alone. 97.4% of patients had access to the online portal. The total number of surveys completed was 194 with a median of 7 per patient (range 1-8). There was a total of 887 abnormal findings reported and 887 documented and corresponding interventions resulting in a 100% intervention rate. Over the course of RT the mean number of abnormal findings increased from 2.26 at baseline (n = 34) to 6.27 at week 7 (n = 24), P < 0.0001. Hospitalizations and Emergency Department (ED) visit data were collected during the study and up to 30 days from last day of RT. There was a total of 2 hospitalizations and 8 ED visits. Conclusions: ePROs integrated within the patient portal and EMR are feasible during RT for patients with head and neck cancer within a large integrated health care system. The use of ePROs integrated within the patient portal and EMR can lead to a high rate of intervention. The increasing number of abnormal findings on ePRO during intensive treatment for head and neck cancer is consistent with known patterns of toxicity and confirm the value of studying methods for improving quality of life in this patient population.[Table: see text]

Objective To determine whether women with multiple sclerosis (MS) diagnosed according to current criteria are at an increased risk of postpartum relapses and to assess whether this risk is modified by breastfeeding or MS disease-modifying therapies (DMTs), we examined the electronic health records (EHRs) of 466 pregnancies among 375 women with MS and their infants. Methods We used prospectively collected information from the EHR at Kaiser Permanente Southern and Northern California between 2008 and 2016 of the mother and infant to identify treatment history, breastfeeding, and relapses. Multivariable models accounting for measures of disease severity were used. Results In the postpartum year, 26.4% relapsed, 87% breastfed, 36% breastfed exclusively for at least 2 months, and 58.8% did not use DMTs. At pregnancy onset, 67.2% had suboptimally controlled disease. Annualized relapse rates (ARRs) declined from 0.37 before pregnancy to 0.14-0.07 (p < 0.0001) during pregnancy, but in the postpartum period, we did not observe any rebound disease activity. The ARR was 0.27 in the first 3 months postpartum, returning to prepregnancy rates at 4-6 months (0.37). Exclusive breastfeeding reduced the risk of early postpartum relapses (adjusted hazard ratio = 0.37, p = 0.009), measures of disease severity increased the risk, and resuming modestly effective DMTs had no effect (time-dependent covariate, p = 0.62). Conclusion Most women diagnosed with MS today can have children without incurring an increased risk of relapses. Women with suboptimal disease control before pregnancy may benefit from highly effective DMTs that are compatible with pregnancy and lactation. Women with MS should be encouraged to breastfeed exclusively.

To describe the risk of postpartum relapses and identify potentially modifiable risk factors in a contemporary multiple sclerosis (MS) cohort.

Background Current cervical dystonia (CD) incidence estimates are based on small numbers in relatively ethnically homogenous populations. The frequency and consequences of delayed CD diagnosis is poorly characterized. Objectives To determine CD incidence and characterize CD diagnostic delay within a large, multiethnic integrated health maintenance organization. Methods We identified incident CD cases using electronic medical records and multistage screening of more than 3 million Kaiser Permanente Northern California members from January 1, 2003, to December 31, 2007. A final diagnosis was made by movement disorders specialist consensus. Diagnostic delay was measured by questionnaire and health utilization data. Incidence rates were estimated assuming a Poisson distribution of cases and directly standardized to the 2000 U.S. census. Multivariate logistic regression models were employed to assess diagnoses and behaviors preceding CD compared with matched controls, adjusting for age, sex, and membership duration. Results CD incidence was 1.18/100,000 person-years (95% confidence interval [CI], 0.35-2.0; women, 1.81; men, 0.52) based on 200 cases over 15.4 million person-years. Incidence increased with age. Half of the CD patients interviewed reported diagnostic delay. Diagnoses more common in CD patients before the index date included essential tremor (odds ratio [OR] 68.1; 95% CI, 28.2-164.5), cervical disc disease (OR 3.83; 95% CI, 2.8-5.2), neck sprain/strain (OR 2.77; 95% CI, 1.99-3.62), anxiety (OR 2.24; 95% CI, 1.63-3.11) and depression (OR 1.94; 95% CI, 1.4-2.68). Conclusions CD incidence is greater in women and increases with age. Diagnostic delay is common and associated with adverse effects. (c) 2019 International Parkinson and Movement Disorder Society

Background. Men with a low-risk prostate cancer (PCa) should consider observation, particularly active surveillance (AS), a monitoring strategy that avoids active treatment (AT) in the absence of disease progression. Objective. To determine clinical and decision-making factors predicting treatment selection. Design. Prospective cohort study. Setting. Kaiser Permanente Northern California (KPNC). Patients. Men newly diagnosed with low-risk PCa between 2012 and 2014 who remained enrolled in KPNC for 12 months following diagnosis. Measurements. We used surveys and medical record abstractions to measure sociodemographic and clinical characteristics and psychological and decision-making factors. Men were classified as being on observation if they did not undergo AT within 12 months of diagnosis. We performed multivariable logistic regression analyses. Results. The average age of the 1171 subjects was 61.5 years ( s = 7.2 years), and 81% were white. Overall, 639 (57%) were managed with observation; in adjusted analyses, significant predictors of observation included awareness of low-risk status (odds ratio 1.75; 95% confidence interval 1.04–2.94), knowing that observation was an option (3.62; 1.62–8.09), having concerns about treatment-related quality of life (1.21, 1.09–1.34), reporting a urologist recommendation for observation (8.20; 4.68–14.4), and having a lower clinical stage (T1c v. T2a, 2.11; 1.16–3.84). Conversely, valuing cancer control (1.54; 1.37–1.72) and greater decisional certainty (1.66; 1.18–2.35) were predictive of AT. Limitations. Results may be less generalizable to other types of health care systems and to more diverse populations. Conclusions. Many participants selected observation, and this was associated with tumor characteristics. However, nonclinical decisional factors also independently predicted treatment selection. Efforts to provide early decision support, particularly targeting knowledge deficits, and reassurance to men with low-risk cancers may facilitate better decision making and increase uptake of observation, particularly AS.

To characterize decision‐making processes and outcomes among men expressing early‐treatment preferences for low‐risk prostate cancer.

As many as 40% of men diagnosed with prostate cancer have low-risk disease, which results in the need to decide whether to undergo active treatment (AT) or active surveillance (AS). The treatment decision can have a significant effect on general and prostate-specific quality of life (QOL). The purpose of this study was to assess the QOL among men with low-risk prostate cancer during the first year following diagnosis. In a prospective cohort study, we conducted pretreatment telephone interviews (N = 1,139; 69.3% response rate) with low-risk PCa patients (PSA ≤ 10, Gleason ≤ 6) and a follow-up assessment 6-10 months postdiagnosis (N = 1057; 93%). We assessed general depression, anxiety, and physical functioning, prostate-specific anxiety, and prostate-specific QOL at both interviews. Clinical variables were obtained from the medical record. Men were 61.7 (SD = 7.2) years old, 82% white, 39% had undergone AT (surgery or radiation), and 61.0% had begun AS. Linear regression analyses revealed that at follow-up, the AS group reported significantly better sexual, bowel, urinary, and general physical function (compared to AT), and no difference in depression. However, the AS group did report greater general anxiety and prostate-specific anxiety at follow-up, compared to AT. Among men with low-risk PCa, adjusting for pretreatment functioning, the AS group reported better prostate-related QOL, but were worse off on general and prostate-specific anxiety compared to men on AT. These results suggest that, within the first year postdiagnosis, men who did not undergo AT may require additional support in order to remain comfortable with this decision and to continue with AS when it is clinically indicated.

Prostate Cancer (PCa) is the second most prevalent cancer among U.S. males. In recent decades many men with low risk PCa have been over diagnosed and over treated. Given significant co-morbidities associated with definitive treatments, maximizing patient quality of life while recognizing early signs of aggressive disease is essential. There remains a need to better stratify newly diagnosed men according to the risk of disease progression, identifying, with high sensitivity and specificity, candidates for active surveillance versus intervention therapy. The objective of this study was to select fluorescence in situ hybridization (FISH) panels that differentiate non-progressive from progressive disease in patients with low and intermediate risk PCa.

Objective: To determine if lower vitamin D levels are associated with an increased risk of postpartum relapses. Background: Multiple sclerosis (MS) affects more than 280,000 American women, most of whom develop the disease during their reproductive years. The fear of postpartum relapses influences family planning, treatment and breastfeeding choices, yet little is known about how to minimize relapse risk. An attractive hypothesis is the vitamin D-MS relapse relationship because vitamin D deficiency is endemic worldwide, particularly in pregnant and lactating women, offering a potentially high-impact strategy to reduce postpartum relapses. Design/Methods: We prospectively followed 89 pregnant women with MS from Kaiser Permanente Southern and Northern California for one year postpartum. Serum 25-hydroxyvitamin D (25OHD) was measured using liquid chromatography, tandem mass spectrometry during third trimester, one and three months postpartum. Other exposures and outcomes were collected from structured interviews and electronic health records. Data were analyzed using longitudinal multivariable methods. Results: During pregnancy, most women (88%) were vitamin D sufficient (u003e30 ng/mL) and took prenatal vitamins (93%) but no additional vitamin D supplements (78%). The median 25OHD level was 38 ng/mL (interquartile range, 32–42). Lower pregnancy levels were not associated with an increased risk of postpartum relapses ( Conclusions: Lower vitamin D levels during pregnancy or early postpartum were not associated with an increased risk of postpartum relapses. Taken together with previous studies, our findings imply that extra vitamin D supplementation beyond prenatal vitamins is unlikely to decrease the risk of postpartum MS relapses. Study Supported by: National Multiple Sclerosis Society (RG4809-A PI: Langer-Gould) Disclosure: Dr. Smith has nothing to disclose. Dr. Leimpeter has nothing to disclose. Dr. Albers has nothing to disclose. Dr. Kerezsi has nothing to disclose. Dr. McClearnen has nothing to disclose. Dr. Van Den Eeden has nothing to disclose. Dr. Langer-Gould has nothing to disclose.

BACKGROUND:A 17-gene biopsy-based reverse transcription polymerase chain reaction assay, which provides a Genomic Prostate Score (GPS-scale 0-100), has been validated as an independent predictor of adverse pathology and biochemical recurrence after radical prostatectomy (RP) in men with low- and intermediate-risk prostate cancer (PCa). OBJECTIVE:To evaluate GPS as a predictor of PCa metastasis and PCa-specific death (PCD) in a large cohort of men with localized PCa and long-term follow-up. DESIGN, SETTING, AND PARTICIPANTS:A retrospective study using a stratified cohort sampling design was performed in a cohort of men treated with RP within Kaiser Permanente Northern California. RNA from archival diagnostic biopsies was assayed to generate GPS results. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:We assessed the association between GPS and time to metastasis and PCD in prespecified uni- and multivariable statistical analyses, based on Cox proportional hazard models accounting for sampling weights. RESULTS AND LIMITATIONS:The final study population consisted of 279 men with low-, intermediate-, and high-risk PCa between 1995 and 2010 (median follow-up 9.8 yr), and included 64 PCD and 79 metastases. Valid GPS results were obtained for 259 (93%). In univariable analysis, GPS was strongly associated with time to PCD, hazard ratio (HR)/20 GPS units=3.23 (95% confidence interval [CI] 1.84-5.65; p<0.001), and time to metastasis, HR/20 units=2.75 (95% CI 1.63-4.63; p<0.001). The association between GPS and both end points remained significant after adjusting for National Comprehensive Cancer Network, American Urological Association, and Cancer of the Prostate Risk Assessment (CAPRA) risks (p<0.001). No patient with low- or intermediate-risk disease and a GPS of<20 developed metastases or PCD (n=31). In receiver operating characteristic analysis of PCD at 10 yr, GPS improved the c-statistic from 0.78 (CAPRA alone) to 0.84 (GPS+CAPRA; p<0.001). A limitation of the study was that patients were treated during an era when definitive treatment was standard of care with little adoption of active surveillance. CONCLUSIONS:GPS is a strong independent predictor of long-term outcomes in clinically localized PCa in men treated with RP and may improve risk stratification for men with newly diagnosed disease. PATIENT SUMMARY:Many prostate cancers are slow growing and unlikely to spread or threaten a man's life, while others are more aggressive and require treatment. Increasingly, doctors are using new molecular tests, such as the17-gene Genomic Prostate Score (GPS), which can be performed at the time of initial diagnosis to help determine how aggressive a given patient's cancer may be. In this study, performed in a large community-based healthcare network, GPS was shown to be a strong predictor as to whether a man's prostate cancer will spread and threaten his life after surgery, providing information that may help patients and their doctors decide on the best course of management of their disease.

41 Background: Validated biomarkers can improve risk stratification for men with prostate cancer (PCa). A biopsy-based RT-PCR assay that provides a GPS (scale 0-100) has been validated as an independent predictor of adverse surgical pathology and BCR after RP in men with low-risk and low-volume intermediate-risk PCa. We sought to confirm that GPS is a predictor of BCR across the full spectrum of clinical risk (low, intermediate and high) in a large cohort of men with long term follow up within Kaiser Permanente Northern California (KPNC). Methods: From the KPNC clinical database of 6,184 RP treated men diagnosed with NCCN very low, low, intermediate and high-risk PCa between 1995- 2010, we performed a retrospective cohort study using stratified cohort sampling. BCR was defined as either 2 successive post-RP PSAs ≥ 0.2, or initiation of salvage therapy after a rising PSA ≥ 0.1. Archival biopsy tissue was assayed to yield a GPS. Univariable and multivariable Cox proportional hazards models were used to estimate the association, accounting for sampling weights and covariates. Results: Tissue was retrieved for 334 patients. 279 met all eligibility criteria and 259 (93%) generated a valid GPS. The cohort consisted of 117 BCR and 142 non-BCR events. GPS was strongly associated with BCR - HR/20 GPS units = 2.5; p < 0.0001 in univariable analysis, and after adjusting for PSA, clinical T stage and central biopsy Gleason Score (HR/20 units = 2.1; p = 0.002). The association between GPS and BCR was similar within different racial groups. Each of the 4 gene groups in GPS contributed to the prediction of BCR. Conclusions: GPS was associated with BCR independently of other clinical factors in surgically treated men with PCa, and may provide improved risk stratification beyond clinical risk assessment.

Background: Due to the concerns about the overtreatment of low-risk prostate cancer, active surveillance (AS) is now a recommended alternative to the active treatments (AT) of surgery and radiotherapy. However, AS is not widely utilized, partially due to psychological and decision-making factors associated with treatment preferences.Methods: In a longitudinal cohort study, we conducted pretreatment telephone interviews (N = 1,140, 69.3% participation) with newly diagnosed, low-risk prostate cancer patients (PSA <= 10, Gleason <= 6) from Kaiser Permanente Northern California. We assessed psychological and decision-making variables, and treatment preference [AS, AT, and No Preference (NP)].Results: Men were 61.5 (SD, 7.3) years old, 24 days (median) after diagnosis, and 81.1% white. Treatment preferences were: 39.3% AS, 30.9% AT, and 29.7% NP. Multinomial logistic regression revealed that men preferring AS (vs. AT) were older (OR, 1.64; CI, 1.07-2.51), more educated (OR, 2.05; CI, 1.12-3.74), had greater prostate cancer knowledge (OR, 1.77; CI, 1.43-2.18) and greater awareness of having low-risk cancer (OR, 3.97; CI, 1.96-8.06), but also were less certain about their treatment preference (OR, 0.57; CI, 0.41-0.8), had greater prostate cancer anxiety (OR, 1.22; CI, 1.003-1.48), and preferred a shared treatment decision (OR, 2.34; CI, 1.37-3.99). Similarly, men preferring NP (vs. AT) were less certain about treatment preference, preferred a shared decision, and had greater knowledge.Conclusions: Although a substantial proportion of men preferred AS, this was associated with anxiety and uncertainty, suggesting that this may be a difficult choice.Impact: Increasing the appropriate use of AS for low-risk prostate cancer will require additional reassurance and information, and reaching men almost immediately after diagnosis while the decision-making is ongoing. (C) 2016 AACR.

1 Cancer Prevention and Control Program, Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC 2 Division of General Internal Medicine, University of Iowa Carver College of Medicine/Iowa City VA Medical Center 3 Department of Biostatistics, Bioinformatics, and Biomathematics, Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC 4 Division of Research, Kaiser Permanente Northern California 5 Department of Urology, Kaiser Permanente East Bay, Oakland, California

April 18, 2016April 5, 2016Free AccessBlepharospasm in a Multiethnic Population (P3.348)Erica Byrd, Kathleen Albers, Samuel Goldman, Jeffrey Klingman, Raymond Lo, Connie Marras, Amethyst Leimpeter, … Show All … , Robin Fross, Kathleen Comyns, Zhuqin Gu, Maya Katz, Laurie Ozelius, Susan Bressman, Rachel Saunders-Pullman, Cynthia Comella, Lorene Nelson, Stephen Van Den Eeden, and Caroline Tanner Show FewerAuthors Info & AffiliationsApril 5, 2016 issue86 (16_supplement)https://doi.org/10.1212/WNL.86.16_supplement.P3.348 Letters to the Editor

Objective: To identify prodromal patterns of diagnoses in PD, DLB, MSA and PSP using the EMR. Background: Prodromal features [e.g., hyposmia, constipation, rapid eye movement sleep behavior disorder (RBD)] precede PD by years (Ross, 2011), and may be identified in the EMR before PD diagnosis (Savica 2009, Schrag 2015). Whether prodromal diagnoses in the EMR precede the onset of parkinsonism other than PD has not been investigated. Methods: Newly diagnosed neurologist confirmed cases with parkinsonism due to PD, DLB, MSA or PSP and controls matched by age, gender and duration of membership were identified from Northern California Kaiser Permanente between 2004-2010. The association of selected prodromal diagnoses with each parkinsonian syndrome was determined using odds ratios (OR) adjusted for age, gender, duration of membership and smoking behavior. Results: 2717 PD/13585 controls, 291 DLB/1455 controls, 80 MSA/890 controls and 84 PSP/840 were studied. Future diagnosis of PD was associated with prior diagnoses of RBD (OR 3, 95[percnt] CI 1.8,5.1), constipation (OR 2.8, 95[percnt] CI 2.5,3.1), hyposmia (OR 1.9, 95[percnt] CI 1.2,3.0), neurogenic bladder (OR 1.6, 95[percnt] CI 1.2,2.3) or seborrheic dermatitis (OR 1.6, 95[percnt] CI 1.3,2.0). Future diagnosis of DLB was associated with prior diagnosis of RBD (OR 21.2, 95[percnt] CI 5.8,77.3) or constipation (OR 2.6, 95[percnt] CI 1.8,3.6). Future diagnosis of MSA was associated with prior diagnosis of neurogenic bladder (OR 21.9, 95[percnt] CI 2.5,192.4) or constipation (OR 6.0, 95[percnt] CI 2.0,8.2). Future diagnosis of PSP was associated with prior diagnosis of neurogenic bladder (OR 9.9, 95[percnt] CI 1.5, 65.8). Conclusions: Antecedent diagnoses predicting PD were confirmed. Different patterns of antecedent diagnoses were associated with future DLB, MSA or PSP. Caveat: clinical distinction of parkinsonian syndromes in early disease may be inaccurate. Electronic record surveillance may help to predict those at risk for PD, DLB, MSA or PSP.