Vector Oncology
  • Memphis, Tennessee, United States
Recent publications
Background: To compare quality of life of patients treated with cetuximab with or without radiation therapy (±RT) vs. cisplatin±RT for locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN) in the real-world setting. Methods: In this retrospective observational study, electronic medical records and Patient Care Monitor (PCM) survey data from the Vector Oncology Data Warehouse were utilized from adult patients in the United States who received initial treatment with cetuximab±RT or cisplatin±RT for locoregionally advanced SCCHN between January 1, 2007 and January 1, 2017. Quality of life was assessed using PCM index scores and individual PCM items. Cetuximab±RT and cisplatin±RT cohorts were balanced using propensity score weighting. Linear mixed models were used to assess the impact of baseline demographic and clinical characteristics on PCM endpoints. Results: Of 531 patients with locoregionally advanced SCCHN, 187 received cetuximab±RT, and 344 received cisplatin±RT. Before propensity score weighting, the cetuximab±RT cohort was older (mean [SD] age of 63.9 [9.6] years vs. 57.4 [8.6] years), and more likely to be white (82.4% vs. 72.4%) compared to the cisplatin±RT cohort. After propensity score weighting, the two cohort subsamples (cetuximab±RT, N = 60; cisplatin±RT, N = 177) with PCM data showed no significant differences in General Physical Symptoms, Treatment Side Effects, Impaired Ambulation, or Impaired Performance index scores. Patients in the cetuximab±RT cohort had higher Acute Distress index (p = 0.023), Despair index (p = 0.011), and rash (p = 0.003) scores but lower numbness/tingling scores (p = 0.022) than patients in the cisplatin±RT cohort. Conclusions: Significant group differences were observed in this comparative analysis, as the cetuximab±RT cohort had significantly higher Acute Distress index, Despair index, and rash scores compared with the cisplatin±RT cohort but lower numbness/tingling scores. These patterns of symptoms appear consistent with previously reported symptoms associated with the treatment of SCCHN.
The aim of this retrospective study was to assess the efficacy of topical hormonal therapy (THT) to relieve vaginal symptoms resulting from antihormonal therapy in women with hormone receptor–positive breast cancer. A total of 74 breast cancer patients who received THT for vaginal complaints were retrospectively identified and statistically matched with 74 control breast cancer patients with vaginal complaints with no documented use of THT. Symptom scores were recorded from the center’s proprietary patient-reported outcomes database, Patient Care Monitor (ConcertoHealthAI, Boston). A baseline score was noted at the initiation of antihormonal therapy and was followed at 6 and 12 months. The median differences between baseline, 6-month, and 12-month scores were analyzed. Repeated measures analysis of variance assessed the impact of topical hormonal replacement. There was no statistically significant difference in score change between the two groups at 6 and 12 months. In the active THT group, there were no statistically significant differences in vaginal complaints or sexual problems over time: {F (2, 146) = 0.99, P = 0.369; and F (2, 146) = 1.56, P = 0.217}, respectively. In this study, the use of topical hormonal replacement was not effective in alleviating vaginal symptoms.
Purpose Unintentional weight loss (UWL) is a prevalent problem in people with cancer and is associated with poorer psychosocial outcomes. A gap exists in understanding whether and how perceived and/or weight status impacts experiences of UWL. Thus, we sought to examine subjective experiences of UWL in people with cancer, and whether perceived and/or actual weight status impacts these experiences. Methods Participants were recruited through Cancer Support Community’s Cancer Experience Registry® and related networks. Participants completed an online survey that included the FAACT Anorexia-Cachexia subscale, and 19 items that captured six themes related to “beliefs and concerns” (positive beliefs, psychosocial impact, physical impact, cancer outcomes, self-esteem, relationships with others). Perceived weight status (PWS) was assessed using a single item. Body mass index (BMI) was calculated using self-reported weight and height measurements. Results Of 326 respondents, 114 reported experiencing UWL. Over one-third misperceived their weight, with 29% perceiving weight status as below their BMI status. UWL in those with perceived weight status of overweight/obese was associated with positive beliefs. However, being underweight by BMI or perceiving oneself as underweight were both associated with greater concerns about weight loss. Perceived weight status of underweight compared to normal or overweight/obese weight status was associated with poorer psychosocial well-being, personal control, self-esteem, and relationships with others. Conclusion In people with cancer, perceived weight status, rather than BMI, had greater impact on negative “beliefs and concerns” about UWL. Findings suggest assessment of both perceived and actual BMI to address the impact of UWL on psychosocial wellbeing.
Purpose Metastatic neuroendocrine tumors (mNETs) are rare, heterogeneous tumors that present diagnostic and treatment challenges, with limited data on the management of mNETs in clinical practice. The present study was designed to identify current diagnostic and treatment patterns in mNET patients treated in the US community oncology setting. Methods Patient-level data was collected from medical records of adults with mNETs from the Vector Oncology Data Warehouse, a comprehensive US community oncology network database. Results Of the 263 patients included (median follow-up, 22 months; range, 0.1–193.9), 30.4% (80/263) had intestinal tumors, 11.0% (29/263) had pancreatic, and 58.6% (154/263) had tumors of other or unknown location. Progression-free survival (PFS) from the start of first-line therapy differed significantly by tumor grade (log rank P = 0.0016) and location (P = 0.0044), as did overall survival (OS) (grade, P < 0.0001; location, P = 0.0068). Median PFS and OS for patients with undocumented tumor grade were shorter than for patients with G1/G2 tumors and longer than patients with G3 tumors. Median PFS and OS for patients with other or unknown tumors were shorter than for patients with intestinal tumors. Conclusions While potentially confounded by the high number of patients with other or unknown tumor locations, this retrospective study of patients in a US community oncology setting identified the importance of awareness of tumor grade and tumor location at diagnosis, as these were direct correlates of PFS and OS.
Fulvestrant monotherapy is approved for postmenopausal women with hormone receptor‐positive, metastatic breast cancer (MBC) who progressed following antiendocrine therapy, or those with hormone receptor‐positive, human epidermal receptor 2‐negative advanced breast cancer (BC) not previously treated with endocrine therapy (ET). However, real‐world data are lacking. Retrospective reviews of 10 United States community oncology practices identified patients diagnosed with MBC between 1 January 2011 and 31 December 2015 who received fulvestrant as the first ET, either as initial therapy for metastatic disease or after progression following one line of chemotherapy. Endpoints were progression‐free survival (PFS) and overall survival (OS). Patients were classified as ET‐naïve or by relapse status following adjuvant ET (“early” recurrence during or ≤12 months of completing adjuvant ET, or “late” >12 months after completing adjuvant ET). Outcomes were evaluated using Kaplan‐Meier methods. Among 121 patients, median PFS (95% confidence interval) was 8.3 months (4.8‐12.3) for early relapse, 15.4 months (10.2‐21.2) for late relapse, and 18.7 months (10.1‐20.8) among ET‐naïve patients (P = .018). Median OS was 39.8 months (25.0‐55.1) for early relapse and 61.4 months (47.1‐61.4) for late relapse, but was not reached (NR; 55.6–NR) for ET‐naïve patients (P = .002). Fulvestrant monotherapy as the first ET after MBC diagnosis demonstrates PFS comparable to clinical study results; outcomes appeared better in patients without prior ET exposure and in patients with disease recurrence >12 months following adjuvant ET. These findings support fulvestrant monotherapy in patients with hormone receptor‐positive MBC.
e23181 Background: The National Comprehensive Cancer Network and the American Society of Clinical Oncology recommend that providers encourage early advance care planning with their patients ¹ ; yet, many cancer patients do not have advance directives (ADs). A potential reason for low AD rates is inadequate communication between the provider and patient. To address this gap, we developed an outpatient clinic AD initiative for any stage cancer patients via an ePRO system. The AD module was designed to ensure that patients are aware of ADs and to assess whether or not the patient had ADs, specifically a Living Will and/or a durable power of attorney. The study purpose was to assess patient AD status at the patient’s initial visit to an oncology clinic. Methods: This study used a retrospective, observational design that involved use of PRO and clinical data collected via the Patient Care Monitor™ (PCM), a web-based ePRO system linked to electronic medical record data. All data used in this study were collected as part of routine clinical care. All patients at an initial visit to an oncology clinic completed the PCM survey, including the AD module, via a handheld e-tablet. Results: Overall, 9,682 patients completed the AD module (mean age 63; 31% male/69% female; 58% married; 62% White, 35% Black). Cancer type was known for 75% of all patients (29% breast, 11% hematologic, 7% lung, 7% colorectal, 3% prostate, 17% other types). One third of all patients (33%) reported having an AD at the time of the initial visit to the oncology clinic, specifically 24% indicated having a Living Will and 9% a durable power of attorney. The remaining two-thirds (67%) indicated either NOT having an AD (56%) or not knowing if they had an AD (11%). Patients with ADs were more likely to be older ( M=68 v. 60 yrs), male (38% v 31%), White (41% v 20% Black) and married/partnered (35% v 29%); ps <.0001. Conclusions: This study demonstrates that the majority of patients do not have ADs at the time of an initial visit to a community-based oncology practice. Using an ePRO system can be an innovative and efficient way to identify unmet needs of patients and link them to resources for developing advance directives. ¹ Brown AJ, Shen MJ, Urbauer D, et al. Room for improvement: An examination of advance care planning documentation among gynecologic oncology patients. Gynecol Oncol. Sep 2016;142(3):525-530.
Aim: Little is known about recent treatment patterns among patients with unresected stage III NSCLC in the real world. This retrospective study used medical records from USA community oncology practices to address this knowledge gap. Materials & methods: Eligible patients were stage III NSCLC adults diagnosed between 1 January 2011 and 1 March 2016 without surgical resection. Treatment patterns were assessed across three progression intervals, from stage III diagnosis through third progression. Results: The most common regimen in interval 1 was platinum doublet chemotherapy + radiation therapy, in interval 2 was chemotherapy only, and in interval 3 was non-platinum chemotherapy monotherapy. Conclusion: Most patients were treated following national guidelines, but important unmet needs remain.
Background: CancerSupportSource (CSS) is a 25-item distress screening tool implemented at community-based cancer support organizations and hospitals nationwide. CSS assesses distress over 5 domains: (1) emotional concerns (including depression and anxiety risk screening subscales), (2) symptom burden, (3) body and healthy lifestyle, (4) healthcare team communication, and (5) relationships. This study developed a short form of CSS and examined its psychometric properties. Methods: 2,379 cancer survivors enrolled in the Cancer Support Community’s Cancer Experience Registry. Participants provided demographic and clinical background and completed CSS-25 and PROMIS-29, a measure of health-related quality of life. Item reduction was conducted with a subsample of 1,435 survivors and included external item quality (correlations between items and PROMIS-29 scales), internal item quality (inter-item and inter-factor correlations, factor loadings and structure, and item communalities from an exploratory factor analysis of CSS-25), and professional judgement (ranking/prioritization of items by CSS-25 developers, accounting for theoretical and practical implications). Pearson correlations and confirmatory factor analysis were conducted on a separate subsample of 944 survivors to corroborate psychometric properties and dimensionality of the shortened scale. Results: Scale refinement resulted in a 15-item short form of CSS (CSS-15). At least 1 item from each of the 5 CSS-25 domains was retained to preserve multidimensionality, including anxiety and depression risk screening subscale items. Additionally, 1 item about tobacco/substance use was kept due to clinical significance for risk assessment. In confirmatory factor analysis, the model explained 59% of the variance and demonstrated good fit (RMSEA=0.068, 90% CI=0.061–0.075; SRMR=0.033; CFI=0.959; χ² (68)=334.75, P<.001). Correlation between CSS-15 and CSS-25 was 0.986, P <.001. Total distress was associated with PROMIS subscales ( r s=−.65–.75, p s<.001); internal consistency reliability was excellent ( α =.92). Conclusions: CSS-15 is a brief, reliable, and valid multidimensional measure of distress. The reduced measure retained excellent internal consistency and a stable factor structure, while correlating well with CSS-25 and PROMIS-29. CSS-15 can serve as a practical tool to efficiently screen for distress among cancer patients and survivors.
Background: Despite growing recognition that patient preferences and values should inform cancer care, patients’ views continue to be under-represented. We developed a quantitative tool, Valued Outcomes in the Cancer Experience (VOICE), to measure patient priorities and to understand discrepancies between what matters most to patients and what patients believe they can control. This study presents VOICE development and initial validation. Methods: 459 cancer patients completed an online survey and rated level of importance and perceived control for 54 value items (0=not at all; 4=very much). Items were derived from patient and caregiver focus groups and included themes such as independence, functional abilities, planning for the future, symptom management, health knowledge, and social support. Participants also completed validated measures of hope, optimism, quality of life, financial toxicity, spiritual well-being, illness perceptions, social support, self-efficacy, intolerance of uncertainty, and cancer-related distress. Iterative exploratory factor analysis (EFA) with direct oblique rotation, magnitude of importance and control ratings, and Pearson correlations between items and validation measures were used to inform scale refinement. Results: Participants were 86% non-Hispanic white; mean age=60 years, SD=10; 38% breast cancer, 18% blood, 9% lung, 9% prostate; mean time since diagnosis=6.5 years, SD=6; 22% metastatic. Items that did not load in the EFA, or were not associated with conceptually relevant validation measures, were removed or reworded. The final EFA explained over half of the variance in the data and demonstrated good fit, with absolute and relative fit indices in established acceptable ranges (P<.001). The refined VOICE measure addresses diverse themes including access to care, maintaining independence, longevity, shared decision making, illness understanding, symptom management, emotional support, connection to illness community, spirituality, and end of life preparation. Conclusions: The study results demonstrate a framework for developing a quantitative, multidimensional measure of patient values. By understanding what matters most to patients, VOICE is positioned to bring patient preferences to the foreground of cancer care, contribute to shared decision making, and enhance care. Next steps include further validation of this tool in diverse settings, including oncology practices and community-based organizations.
Purpose: Bevacizumab is a standard first-line (L1) treatment for metastatic colorectal cancer (mCRC) patients regardless of RAS status. This retrospective study examined treatment patterns and outcomes in a community oncology sample of KRAS mutant mCRC patients treated with chemotherapy (C) or C plus bevacizumab (CB) in L1. Methods: This study used medical records from the Vector Oncology Data Warehouse. Eligible patients were confirmed KRAS mutant mCRC and received L1 C or CB. Kaplan-Meier analysis assessed L1 progression-free survival (PFS) and overall survival (OS). Cox regression models examined the interaction of tumor location (R/L) with treatment. Results: CB (n = 264) compared to C (n = 109) patients were younger, less likely performance status (PS) impaired, and more likely with liver metastases. Median unadjusted PFS was 10.41 months (95% CI 9.0-11.3) in CB and 7.66 months (95% CI 6.5-9.1) in C patients (p = 0.174). Median unadjusted OS was 26.91 months (95% CI 24.3-29.3) in CB and 23.33 months (95% CI 19.7-29.2) in C patients (p = 0.571). For patients with right- vs. left-sided tumors, C (but not CB)-treated patients had higher adjusted risk for progression (HR = 1.715, 95% CI 1.108, 2.653; p = 0.015). Conclusions: CB- vs. C-treated KRAS mutant mCRC patients may have a meaningful PFS benefit. Patients with right-sided tumors treated with C were at higher risk for disease progression than patients with left-sided tumors. Tumor location had no significant effect on outcomes in the CB cohort.
Purpose: Patients with Kirsten rat sarcoma viral oncogene wild-type (KRAS WT) metastatic colorectal cancer (mCRC) treated in first line with bevacizumab (B) or cetuximab (C) plus standard chemo backbones had comparable outcomes in phase III Cancer and Leukemia Group B (CALGB) 80405. We examined comparative effectiveness of B and C regimens in real-world community settings. Methods: This retrospective study examined progression-free survival (PFS) and OS in a US community sample of KRAS WT mCRC patients treated with first-line B (n = 254) or C (n = 146) regimens. Medical records from the Vector Oncology Data Warehouse were used. Disease progression was determined from patient charts. OS was measured from the start of first-line treatment until death. Results: There were no significant difference in either PFS or OS respectively between B-treated compared to C-treated patients (HR = 1.324, 95% CI 0.901, 1.947; HR = 1.080, 95% CI 0.721, 1.617). More B patients received oxaliplatin backbones (74.8 vs. 36.3%), and more C patients received irinotecan backbones (51.4 vs. 20.1%), ps < 0.001. Multivariate survival analyses showed a significant difference indicating a greater risk for death among C-treated patients with right-sided tumors vs. left-sided tumors (HR = 2.263, 95% CI 1.394, 3.673, p = 0.0009), but not for B-treated patients (HR = 1.209, 95% CI 0.825, 1.771, p = 0.3297). Conclusions: Consistent with CALGB 80405, median PFS and OS for these community oncology KRAS WT mCRC patients treated with first-line B or C regimens did not differ significantly.
Objectives: To determine the feasibility and acceptability of a validated electronic distress screening program for cancer caregivers. Sample & setting: 17 informal caregivers presenting with a patient with cancer to an ambulatory cancer surgery center. Methods & variables: Caregivers completed the CancerSupportSource®-Caregiver screening and a brief semistructured interview concerning the screening. Results: Caregivers described the screening as straightforward and comprehensive. They endorsed concerns about their self-care needs but were most likely to request information or a referral for patient-focused concerns. Referrals generated from the program are likely viably addressed with existing supportive care resources. Implications for nursing: Brief, caregiver-focused distress screening is perceived positively by caregivers. Caregivers indicated that they felt it validated the importance of their role and highlighted the hospital's efforts to continually improve care. This screening program may be particularly beneficial in ambulatory surgical centers to efficiently identify caregivers with concerns and provide a point of entry to remediate these concerns.
This study examined real-world clinical outcomes such as progression-free survival (PFS), time to metastasis (TTM), overall survival (OS), and health-related quality of life (HRQOL) in patients with unresected stage III non-small cell lung cancer (NSCLC) treated in the community setting. A retrospective review of medical records extracted from 10 US community oncology practices was conducted. Eligible patients were adults diagnosed with stage III NSCLC from 1/1/2011 to 3/1/2016 without evidence of surgical resection within 6 months after stage III NSCLC diagnosis (index date). PFS, OS, and TTM were assessed from the index date, and were analyzed using Kaplan–Meier and Cox regression analyses. HRQOL was assessed for a subset of patients using a patient-reported measure, the 86-item Patient Care Monitor (PCM). Linear mixed models (LMM) were used to assess the impact of patient characteristics and change in PCM scores associated with progression. Among the sample of 478 patients, median PFS (95% confidence interval) was 10 months (9–11), median OS was 20 months (17–22), and median TTM was 30 months (23–45). Most patients (58.2%) experienced disease progression, which the LMM showed to be associated with significant worsening of physical symptoms and psychological states (p < 0.001). This study documented PFS and OS consistent with published literature. The majority of patients experienced disease progression, which was associated with worsening of HRQOL. These findings highlighted the need for better therapeutic options in patients with unresected stage III NSCLC with potential to improve patient outcomes and HRQOL.
Objective Social support is a critical component of breast cancer care and is associated with clinical and quality of life outcomes. Significant health disparities exist between Black and White women with breast cancer. Our study used qualitative methods to explore the social support needs of Black and White women with hormone receptor‐positive breast cancer on adjuvant endocrine therapy (AET). Methods We conducted four focus group (FG) interviews (N=28), stratified by race (i.e., Black and White) and time on AET. FGs were audiotaped, transcribed, and analyzed according to conventions of thematic analysis. Results Participants noted the importance of having their informational and emotional social support needs met by friends and family members. White participants reported support provided by others with breast cancer was crucial; Black women did not discuss other survivors as part of their networks. Notably, both White and Black participants used the FG environment to provide experiential social support to each other. Conclusions White participants noted that having other breast cancer survivors in their support network was essential for meeting their social support needs. However, Black participants did not reference other breast cancer survivors as part of their networks. Cancer centers should consider reviewing patients’ access to experiential support and facilitate opportunities to connect women in the adjuvant phase.
Background: Chronic lymphocytic leukemia (CLL) progresses with time and, as a result, patients can be challenged by considering multiple treatment options. Importantly, over the past decade, an array of new CLL treatments have emerged, including targeted therapy and immunotherapy options. Health care teams, therefore, play an important role in discussing new treatments with patients to ensure shared decision making. A substantial proportion of patients, however, report not discussing newly approved treatment options with clinicians. Our goal was to understand the sociodemographic and clinical factors associated with doctors' likelihood of discussing new treatment options in a national sample of CLL patients. Methods: Using data from the Cancer Support Community's Cancer Experience Registry®, our analytic sample included 187 participants who report CLL as their primary diagnosis. The dependent variable in all analyses was a dichotomous, patient-reported indicator of whether or not their doctor discussed new treatment options (e.g., ibrutinib, idealisib, obinutuzumab) with them. Our independent variables included: 1) sociodemographic characteristics: age, gender, education, urbanicity, and race; 2) clinical factors: genetic risk, treatment status, years since diagnosis, CLL risk (low, intermediate or high; based on patient report of how doctor estimated their CLL may progress over time), and relapse; and 3) patient-clinician communication: patient involvement in treatment decision making, patient's consideration of financial cost of care, discussion of health care team's goals for treatment, and discussion of patient's goals for treatment. Our analyses proceeded in two steps. First, we descriptively compared patients who discuss new treatments with their doctors and those who do not using Student's t-test. Second, multivariate logistic regression models estimated likelihood of doctor discussing new treatment options by sociodemographic, clinical, and patient-provider characteristics. Multiple imputation accounted for missingness in our regression models. Results: Our sample was 48% female, 96% White, and averaged 62 years of age (SD = 10), with a mean time since diagnosis of 7 years (SD = 5). 18% of our sample reported having a deletion 17p, 22% reported having a deletion 13q, 22% were currently receiving chemotherapy, and 16% reported recurrence of their CLL. 58% of our sample reported discussing new treatment options with their doctor. Descriptively, patients who report higher frequencies of cancer recurrence, intermediate or high risk of their CLL, genetic testing results indicative of deletion 17p and deletion 13q, current chemotherapy, greater involvement in treatment decision making, and lower consideration of financial cost of care were significantly more likely to discuss new treatment options with their doctors. In multivariate models, controlling for all sociodemographic, clinical, and patient-clinician characteristics, our results highlight a greater likelihood of discussing new options among patients who have experienced a relapse of their CLL. Conclusion: Nearly half of our CLL patients did not report discussing new treatment options with their clinician, raising concerns about whether shared decision-making is really taking place in the era of novel CLL therapeutics. While those who experience a relapse are significantly more likely to discuss new treatment options, unmet needs remain. As new treatments are incorporated into standard of care, greater efforts are needed to enhance shared decision-making at all points of care. Disclosures Buzaglo: Vector Oncology: Employment.
189 Background: Despite curative treatment intent, most patients (pts) with unresected Stage III NSCLC progress to metastatic disease. Prior research has shown significant benefits on clinical outcomes when HRQoL is assessed in clinical care, but understanding is limited in Stage III NSCLC. Methods: A retrospective review of community oncology medical records was conducted to examine real-world clinical outcomes such as overall and progression-free survival. Eligible pts were adults diagnosed from 1/1/2011 to 3/1/2016 with unresected Stage III NSCLC. In a subset of patients with available data, HRQoL was assessed using the 86-item Patient Care Monitor (PCM), a patient reported measure. Linear mixed models (LMM) were used to assess the impact of pt characteristics and change in PCM scores associated with progression. Results: The main sample included 478 pts: mean [SD] age was 67 [10] years, 55% male, 72% Caucasian, and 71.1% initially treated with concurrent chemoradiation. HRQoL analysis included 167 pts. LMM showed significant worsening of Index scores for General Physical Symptoms, Treatment Side Effects, Despair, and Impaired Ambulation (p < 0.001) as well as Acute Distress (p = 0.044) at progression. Of the six symptoms analyzed, significant worsening of scores at progression occurred in pain, difficulty breathing, and fatigue (p < 0.001). HRQoL consistently worsened at progression, but the pattern of severity for Index scores varied when separately evaluated in the pre- and post-progression periods. Symptom patterns showed improvement for Treatment Side Effects, Acute Distress, and Despair during the pre-progression period, but worsened post-progression, an effect that exceeded the pre-progression improvement. Receipt of radiation and increasing age were associated with better overall HRQoL; HRQoL tended to be worse in pts with greater comorbidity burden and impaired performance status. Conclusions: Our study demonstrated a pattern of clinically meaningful worsening of HRQoL at progression, with pts reporting worsening physical symptoms and negative psychological states. The results also appear consistent with clinical expectations and show HRQoL benefit of radiation therapy.
Objective: To provide an overview of comparative effectiveness research (CER) methodology and discuss the challenges of health economics and outcomes research (HEOR) in wound care. Approach: Narrative description of HEOR methodology with supporting references. Results: With the increasing costs of clinical trials, the use of observational studies in a real-world setting will be essential. Wound care clinicians should understand the importance of proper methods for conducting CER studies. Propensity score methods and marginal structural modeling can create a "quasi-randomized" environment for measuring wound closure and can help drive informed decision-making. In wound care, a paucity of HEOR information is available with great reluctance to use this information by payers, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, and other agencies. Furthermore, a limited amount of high-quality retrospective data to measure wound care outcomes exist. The U.S. Wound Registry is one of few data sources that accurately reports on outcomes for all wound types and is a Qualified Clinical Data Registry. Innovation and Conclusions: Several CER approaches in observational studies provide sufficiently detailed information to help decision-makers make informed choices about wound care products regarding efficacy in the real-world setting. Using CER and cost-effectiveness studies succinctly needs to be incorporated if progress is to be made in improving wound care outcomes and reducing cost.
Purpose: For postmenopausal women with hormone receptor-positive breast cancer, long-term use of aromatase inhibitors (AIs) significantly reduces the risk of cancer recurrence and improves survival. Still, many patients are nonadherent due to adverse side effects. We conducted a pilot randomized controlled trial to test the use of a web-based application (app) designed with and without weekly reminders for patients to report real-time symptoms and AI use outside of clinic visits with built-in alerts to patients’ oncology providers. Our goal was to improve symptom burden and medication adherence. Methods: Forty-four women with early-stage breast cancer and a new AI prescription were randomized to either an App+Reminder (weekly reminders to use app) or App (no reminders) group. Pre- and post-assessment data were collected from all participants. Results: Participants in the App+Reminder group had higher weekly app usage rate (74% vs. 38%, p<0.05) during the intervention and reported higher AI adherence at 8 weeks (100% vs. 72%, p<0.05). Symptom burden increase was higher for the App group compared to the App+Reminder group, but did not reach statistical significance. Conclusions: Weekly reminders to use a web-based app to report AI adherence and treatment-related symptoms demonstrated feasibility and improved short-term AI adherence, which may reduce symptom burden for women with breast cancer and a new AI prescription. Implications: If short-term gains in adherence persist, this low-cost intervention could improve survival outcomes for women with breast cancer. A larger, long-term study should examine if AI adherence and symptom burden improvements persist for a five-year treatment period.
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