Low utilization of palliative care services warrant testing of new solutions to educate and engage patients around the benefits of palliative care.
We sought out to develop and test a novel, mobile ...health solution to prepare patients for an upcoming outpatient palliative care appointment.
After developing a web-based tool called PCforMe (Palliative Care for Me), we conducted a randomized, active-controlled, trial of PCforMe. The primary outcome was the score on the System Usability Scale (SUS). Secondary outcomes were patient self-efficacy and change in knowledge. We compared PCforMe to three common online resources for patients seeking information about palliative care.
A total of 80 patients were randomized. There were no significant demographic differences. Mean SUS score for PCforMe was 78.2, significantly above the normative average SUS score of 68 (P-value < 0.0001). Mean change in Perceived Efficacy in Patient-Physician Interactions score was −2.2 for PCforMe and −1.7 for control group (P-value = 0.72). Preparedness for an upcoming palliative care visit increased 50% in the intervention group and 13.3% in the control group. Difference in the number of patients with improved knowledge regarding palliative care approached significance (P = 0.06). Lastly, we found that the no-show rate was lower during Q1 2017 (during trial) and Q1 2016 (before trial), at 11.7% and 21%, respectively (P < 0.05). Comparing the full calendar year (CY) 2016 with 2017, we did not find a statistical difference (CY 2016 of 18.8% and 15% in CY 2017; P = 0.22).
PCforMe is a usable mobile health tool to prepare patients for an upcoming palliative care appointment. Further research is needed to test effectiveness.
To integrate the patient perspective into adverse event reporting, the National Cancer Institute developed a patient-reported outcomes version of the Common Terminology Criteria for Adverse Events ...(PRO-CTCAE).
To assess the construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items.
A total of 975 adults with cancer undergoing outpatient chemotherapy and/or radiation therapy enrolled in this questionnaire-based study between January 2011 and February 2012. Eligible participants could read English and had no clinically significant cognitive impairment. They completed PRO-CTCAE items on tablet computers in clinic waiting rooms at 9 US cancer centers and community oncology practices at 2 visits 1 to 6 weeks apart. A subset completed PRO-CTCAE items during an additional visit 1 business day after the first visit.
Primary comparators were clinician-reported Eastern Cooperative Oncology Group Performance Status (ECOG PS) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30).
A total of 940 of 975 (96.4%) and 852 of 940 (90.6%) participants completed PRO-CTCAE items at visits 1 and 2, respectively. At least 1 symptom was reported by 938 of 940 (99.8%) participants. Participants' median age was 59 years; 57.3% were female, 32.4% had a high school education or less, and 17.1% had an ECOG PS of 2 to 4. All PRO-CTCAE items had at least 1 correlation in the expected direction with a QLQ-C30 scale (111 of 124, P<.05 for all). Stronger correlations were seen between PRO-CTCAE items and conceptually related QLQ-C30 domains. Scores for 94 of 124 PRO-CTCAE items were higher in the ECOG PS 2 to 4 vs 0 to 1 group (58 of 124, P<.05 for all). Overall, 119 of 124 items met at least 1 construct validity criterion. Test-retest reliability was 0.7 or greater for 36 of 49 prespecified items (median range intraclass correlation coefficient, 0.76 0.53-.96). Correlations between PRO-CTCAE item changes and corresponding QLQ-C30 scale changes were statistically significant for 27 prespecified items (median range r=0.43 0.10-.56; all P≤.006).
Evidence demonstrates favorable validity, reliability, and responsiveness of PRO-CTCAE in a large, heterogeneous US sample of patients undergoing cancer treatment. Studies evaluating other measurement properties of PRO-CTCAE are under way to inform further development of PRO-CTCAE and its inclusion in cancer trials.
Aims We evaluated pedometry as a novel patient-cen-tered outcome because it enables passive continuous assessment of activity and may provide information about the consequences of symptomatic ...toxicity complementary to self-report. Methods Adult patients undergoing hematopoietic cell transplant (HCT) wore pedometers and completed PRO assessments during transplant hospitalization (4 weeks) and 4 weeks post-discharge. Patient reports of symptomatic treatment toxicities (single items from PROCTCAE, http://healthcaredelivery. cancer.gov/pro-ctcae) and symptoms, physical health, mental health, and quality of life (PROMIS® Global-10, http://nih.promis.org), assessed weekly with 7-day recall on Likert scales, were compared individually with pedometry data, summarized as average daily steps per week, using linear mixed models. Results Thirty-two patients mean age 55 (SD = 14), 63 % male, 84 % white, 56 % autologous, 43 % allogeneic completed a mean 4.6 (SD = 1.5, range 1-8) evaluable assessments. Regression model coefficients (β) indicated within-person decrements in average daily steps were associated with increases in pain (β = –852; 852 fewer steps per unit increase in pain score, p < 0.001), fatigue (β = –886, p < 0.001), vomiting (β = –518, p < 0.01), shaking/chills (β = –587, p < 0.01), diarrhea (β = –719, p < 0.001), shortness of breath (β = –1018, p < 0.05), reduction in carrying out social activities (β = 705, p < 0.01) or physical activities (β = 618, p < 0.01), and global physical health (β = 101, p < 0.001), but not global mental health or quality of life. Conclusions In this small sample of HCT recipients, more severe symptoms, impaired physical health, and restrictions in the performance of usual daily activities were associated with statistically significant decrements in objectively measured daily steps. Pedometry may be a valuable outcome measure and validation anchor in clinical research.
Reproductive autonomy necessitates that women have access to high quality family planning information and services. Additionally, closely spaced pregnancies increase maternal and infant morbidity and ...mortality. Although integrating family planning into child immunization services may increase access to information and services and postpartum contraceptive use, evidence on how integration affects service delivery and health outcomes is scarce. One limitation of previous studies is the use of binary integration measures. To address this limitation, this study applied Provider and Facility Integration Index scores to estimate associations between integration and contraceptive use, receipt of family planning information, and knowledge of family planning services availability. This study leveraged pooled cross-sectional health facility client exit interview data collected from 2,535 women in Nigeria. Provider and Facility Integration Index scores were calculated (0–10, 0 = low, 10 = high) for each facility (
N
= 94). The Provider Integration Index score measures provider skills and practices that support integrated service delivery; the Facility Integration Index score measures facility norms that support integrated service delivery. Logistic regression models identified associations between Provider and Facility Integration Index scores and (a) contraceptive use among postpartum women, (b) receipt of family planning information during immunization visits, and (c) correct identification of family planning service availability. Overall, 46% of women were using any method of contraception, 51% received family planning information during the immunization appointment, and 83% correctly identified family planning service availability at the facility. Mean Provider and Facility Integration Index scores were 6.46 (SD = 0.21) and 7.27 (SD = 0.18), respectively. Provider and Facility Integration Index scores were not significantly associated with postpartum contraceptive use. Facility Integration Index scores were negatively associated with receipt of family planning information. Provider Integration Index scores were positively associated with correct identification of family planning service availability. Our results challenge the position that integration provides a clear path to improved outcomes. The presence of facility and provider attributes that support integration may not result in the delivery of integrated care.
Background
The National Institute on Aging (NIA) Imbedded Pragmatic Alzheimer's Disease and Alzheimer's Related Dementia Clinical Trials (IMPACT) Collaboratory convened a Lived Experience Panel (LEP) ...to inform the development of research priorities and provide input on conducting embedded pragmatic clinical trials (ePCTs) of dementia care interventions. Given the importance of people with lived experience to dementia research, and the unique considerations of engaging people with dementia, we report on our process for the recruitment, selection, and initial convening of the IMPACT LEP.
Methods
The IMPACT Engaging Partners Team, in partnership with the Alzheimer's Association, sought nominations of individuals with mild cognitive impairment or early‐stage dementia, care partners of other people living with dementia (PLWD), and proxy representatives for individuals with mid‐to‐late stage dementia. The 11‐member LEP was composed of individuals with diverse personal experiences in part due to their age, race, ethnicity, gender, sexual orientation, geography, disability, or type of dementia. In its first year, the LEP met with IMPACT's Patient and Caregiver Relevant Outcomes Core and Ethics and Regulation Core.
Results
LEP members provided valuable insights and nuanced discussion of issues relevant to ePCTs in dementia care from a broad range of personal experience. Panelists identified key research priorities and provided insight on outcomes often studied by researchers. The LEP also informed investigators' approaches to waivers and modifications of written informed consent and evaluation of minimal risk. Summary reports of the LEP meetings with each Core are available on the IMPACT website. At the end of the first year, changes were made to the composition of the LEP, and opportunities were identified for expanding panelist engagement with IMPACT investigators, as were priorities and scope for future input.
Conclusions
The IMPACT LEP provides a model for engaging PLWD and care partners in the research process as collaborators.
Aims:
The US National Cancer Institute recently developed the PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events). PRO-CTCAE is a library of questions ...for clinical trial participants to self-report symptomatic adverse events (e.g. nausea). The objective of this study is to inform evidence-based selection of a recall period when PRO-CTCAE is included in a trial. We evaluated differences between 1-, 2-, 3-, and 4-week recall periods, using daily reporting as the reference.
Methods:
English-speaking patients with cancer receiving chemotherapy and/or radiotherapy were enrolled at four US cancer centers and affiliated community clinics. Participants completed 27 PRO-CTCAE items electronically daily for 28 days, and then weekly over 4 weeks, using 1-, 2-, 3-, and 4-week recall periods. For each recall period, mean differences, effect sizes, and intraclass correlation coefficients were calculated to evaluate agreement between the maximum of daily ratings and the corresponding ratings obtained using longer recall periods (e.g. maximum of daily scores over 7 days vs 1-week recall). Analyses were repeated using the average of daily scores within each recall period rather than the maximum of daily scores.
Results:
A total of 127 subjects completed questionnaires (57% male; median age: 57). The median of the 27 mean differences in scores on the PRO-CTCAE 5-point response scale comparing the maximum daily versus the longer recall period (and corresponding effect size) was −0.20 (−0.20) for 1-week recall, −0.36 (−0.31) for 2-week recall, −0.45 (−0.39) for 3-week recall, and −0.47 (−0.40) for 4-week recall. The median intraclass correlation across 27 items between the maximum of daily ratings and the corresponding longer recall ratings for 1-week recall was 0.70 (range: 0.54–0.82), for 2-week recall was 0.74 (range: 0.58–0.83), for 3-week recall was 0.72 (range: 0.61–0.84), and for 4-week recall was 0.72 (range: 0.64–0.86). Similar results were observed for all analyses using the average of daily scores rather than the maximum of daily scores.
Conclusion:
A 1-week recall corresponds best to daily reporting. Although intraclass correlations remain stable over time, there are small but progressively larger differences between daily and longer recall periods at 2, 3, and 4 weeks, respectively. The preferred recall period for the PRO-CTCAE is the past 7 days, although investigators may opt for recall periods of 2, 3, or 4 weeks with an understanding that there may be some information loss.
Purpose
Emotional and functional well-being (EWB and FWB) are important components of mental health and quality of life. This study aims to evaluate long-term EWB and FWB in breast cancer (BC) ...survivors.
Methods
The Carolina Breast Cancer Study Phase 3 oversampled Black and younger (< 50 years in age) women so that they each represent approximately 50% of the study population and assessed participants’ EWB and FWB with the Functional Assessment of Cancer Therapy—Breast (FACT-B) at 5- (baseline), 25-, and 84-months post diagnosis. Multinomial logit models were used to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for associations between demographic and clinical characteristics and well-being change relative to baseline.
Results
Among 2,781 participants with BC, average EWB and FWB improved with time since diagnosis. Persistent FWB decrements were associated with Black race OR 1.4 (95% CI 1.2–1.7) and 1.3 (95% CI 1.1–1.6), at 25-months and 84-months respectively, older age OR 1.4 (95% CI 1.1–1.7) and 1.5 (95% CI 1.2–1.8), respectively, no chemotherapy, and recurrence OR 2.9 (95% CI 1.8–4.8) and 3.1 (95% CI 2.1–4.6), respectively. EWB decrements were associated with advanced stage and recurrence. Decrements in combined (FWB+EWB) well-being were associated with recurrence at both follow-up survey timepoints ORs 4.7 (95% CI 2.7–8.0) and 4.3 (95% CI 2.8–6.6), respectively.
Conclusions
Long-term well-being varies by demographics and clinical features, with Black women and women with aggressive disease at greatest risk of long-term decrements.
Integrating family planning into child immunization services may address unmet need for contraception by offering family planning information and services to postpartum women during routine child ...immunization visits. However, policies and programs promoting integration are often based on insubstantial or conflicting evidence about its effects on service delivery and health outcomes. While integration models vary, many studies measure integration as binary (a facility is integrated or not) rather than a multidimensional and varying continuum. It is thus challenging to ascertain the determinants and effects of integrated service delivery. This study creates Facility and Provider Integration Indexes, which measure capacity to support integrated family planning and child immunization services and applies them to analyze the extent of integration across 400 health facilities.
This study utilizes cross-sectional health facility (N = 400; 58% hospitals, 42% primary healthcare centers) and healthcare provider (N = 1479) survey data that were collected in six urban areas of Nigeria for the impact evaluation of the Nigerian Urban Reproductive Health Initiative. Principal Component Analysis was used to develop Provider and Facility Integration Indexes that estimate the extent of integration in these health facilities. The Provider Integration Index measures provider skills and practices that support integrated service delivery while the Facility Integration Index measures facility norms that support integrated service delivery. Index scores range from zero (low) to ten (high).
Mean Provider Integration Index score is 5.42 (SD 3.10), and mean Facility Integration Index score is 6.22 (SD 2.72). Twenty-three percent of facilities were classified as having low Provider Integration scores, 32% as medium, and 45% as high. Fourteen percent of facilities were classified as having low Facility Integration scores, 38% as medium, and 48% as high.
Many facilities in our sample have achieved high levels of integration, while many others have not. Results suggest that using more nuanced measures of integration may (a) more accurately reflect true variation in integration within and across health facilities, (b) enable more precise measurement of the determinants or effects of integration, and (c) provide more tailored, actionable information about how best to improve integration. Overall, results reinforce the importance of utilizing more nuanced measures of facility-level integration.
Objective
To identify real‐world patterns of first line treatment, treatment sequence and outcomes for older adults diagnosed with advanced melanoma who received immunotherapy or targeted therapy.
...Methods
The study population included older adults (ages 65+) diagnosed with unresectable or metastatic melanoma between 2012 and 2017 and who received first line immunotherapy or targeted therapy. Using the linked surveillance, epidemiology, and end results‐medicare data, we described patterns of first line treatment and treatment sequence through 2018. We used descriptive statistics to report patient and provider characteristics by first line treatment receipt and changes in first line therapy use over calendar time. We also described overall survival (OS) and time to treatment failure (TTF) by first line treatment using the Kaplan–Meier method. For patterns of treatment sequence, we reported commonly observed treatment switch patterns by treatment sub‐category and calendar year.
Results
The analyses included 584 patients (mean age = 76.3 years). A majority (n = 502) received first line immunotherapy. There was a sustained increase in immunotherapy uptake, most notably from 2015 to 2016. The estimated median OS and TTF were longer with first line immunotherapy than with targeted therapy. Individuals treated with CTLA‐4 + PD‐1 inhibitors had the longest median OS (28.4 months). The most common treatment switch pattern was from a first line CTLA‐4 inhibitor to a second line PD‐1 inhibitor.
Conclusions
Our findings inform understanding of treatment patterns of currently used immunotherapies and targeted therapies in older adults with advanced melanoma. Immunotherapy use has increased steadily with PD‐1 inhibitors becoming a dominant treatment option since 2015.
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