Managing Chronic Pain in Cancer Survivorship: Communication Challenges and Opportunities as Described by Cancer Survivors.

OBJECTIVES: Many cancer survivors experience chronic pain after completing curative-intent treatment. Based on available data, chronic pain may be undertreated in this context; however, little is known about cancer survivors' experiences with clinical management of chronic pain. The purpose of this study was to better understand cancer survivors' pain management experiences after curative-intent treatment. METHODS: We conducted 13 semi-structured interviews with a convenience sample of cancer survivors who had completed treatment for stage I-III breast, head/neck, lung or colorectal cancer. We used a thematic approach to qualitative data analysis. RESULTS: Participants described that chronic pain often goes unrecognized by their providers, potentially due to limitations in how pain is assessed clinically and the tendency of both cancer survivors and providers to minimize or invalidate the pain experience. To improve communication, participants suggested that providers ask more open-ended questions about their pain, help them to establish functional goals, and provide patients with options for pain management. SIGNIFICANCE OF RESULTS: This study demonstrates the importance of provider-initiated communication around pain management for cancer survivors to make them feel more supported in their care. Communication and shared decision-making interventions may improve cancer survivor-provider communication around chronic pain management, addressing an important gap in survivorship care.

Identification of barriers at the primary care provider level to improve inflammatory breast cancer diagnosis and management.

The purpose of this study, based in the United States, was to evaluate knowledge gaps and barriers related to diagnosis and care of inflammatory breast cancer (IBC), a rare but lethal breast cancer subtype, amongst Primary Care Providers (PCP) as they are often the first point of contact when patients notice initial symptoms. PCP participants in the Duke University Health System, federally qualified health center, corporate employee health and community practices, nearby academic medical center, Duke physician assistant and advanced practice nurse leadership program alumni were first selected in a convenience sample and for semi-structured interviews (n = 11). Based on these data, an online survey tool was developed and disseminated (n = 78) to assess salient measures of IBC diagnosis, health disparity factors, referral and care coordination practices, COVID-19 impact, and continuing medical education (CME). PCP reported access to care and knowledge gaps in symptom recognition (mean = 3.3, range 1-7) as major barriers. Only 31 % reported ever suspecting IBC in a patient. PCP (n = 49) responded being challenged with referral delays in diagnostic imaging. Additionally, since the COVID-19 pandemic started, 63 % reported breast cancer referral delays, and 33 % reported diagnosing less breast cancer. PCP stated interest in CME in their practice for improved diagnosis and patient care, which included online (53 %), lunch time or other in-service training (33 %), patient and provider-facing websites (32 %). Challenges communicating rare cancer information, gaps in confidence in diagnosing IBC, and timely follow-up with patients and specialists underscores the need for developing PCP educational modules to improve guideline-concordant care.

Patient Preferences for Postmastectomy Breast Reconstruction.

Importance: Up to 40% of women experience dissatisfaction after breast reconstruction due to unexpected outcomes that are poorly aligned with personal preferences. Identifying what attributes patients value when considering surgery could improve shared decision-making. Adaptive choice-based conjoint (ACBC) analysis can elicit individual-level treatment preferences. Objectives: To identify which attributes of breast reconstruction are most important to women considering surgery and to describe how these attributes differ by those who prefer flap vs implant reconstruction. Design, Setting, and Participants: This web-based, cross-sectional study was conducted from March 1, 2022, to January 31, 2023, at Duke University and between June 1 and December 31, 2022, through the Love Research Army with ACBC analysis. Participants were 105 women at Duke University with a new diagnosis of or genetic predisposition to breast cancer who were considering mastectomy with reconstruction and 301 women with a history of breast cancer or a genetic predisposition as identified through the Love Research Army registry. Main Outcomes and Measures: Relative importance scores, part-worth utility values, and maximum acceptable risks were estimated. Results: Overall, 406 women (105 from Duke University [mean (SD) age, 46.3 (10.5) years] and 301 from the Love Research Army registry [mean (SD) age, 59.2 (11.9) years]) participated. The attribute considered most important was the risk of abdominal morbidity (mean [SD] relative importance [RI], 28% [11%]), followed by chance of major complications (RI, 25% [10%]), number of additional operations (RI, 23% [12%]), appearance of the breasts (RI, 13% [12%]), and recovery time (RI, 11% [7%]). Most participants (344 [85%]) preferred implant-based reconstruction; these participants cared most about abdominal morbidity (mean [SD] RI, 30% [11%]), followed by the risk of complications (mean [SD], RI, 26% [11%]) and additional operations (mean [SD] RI, 21% [12%]). In contrast, participants who preferred flap reconstruction cared most about additional operations (mean [SD] RI, 31% [15%]), appearance of the breasts (mean [SD] RI, 27% [16%]), and risk of complications (mean [SD] RI, 18% [6%]). Factors independently associated with choosing flap reconstruction included being married (odds ratio [OR], 2.30 [95% CI, 1.04-5.08]; P = .04) and higher educational level (college education; OR, 2.43 [95% CI, 1.01-5.86]; P = .048), while having an income level of greater than $75 000 was associated with a decreased likelihood of choosing the flap profile (OR, 0.45 [95% CI, 0.21-0.97]; P = .01). Respondents who preferred flap appearance were willing to accept a mean (SD) increase of 14.9% (2.2%) chance of abdominal morbidity (n = 113) or 6.4% (4.8%) chance of complications (n = 115). Conclusions and Relevance: This study provides information on how women value different aspects of their care when making decisions for breast reconstruction. Future studies should assess how decision aids that elicit individual-level preferences can help tailor patient-physician discussions to focus preoperative counseling on factors that matter most to each patient and ultimately improve patient-centered care.

Stakeholder Perspectives on Factors Related to Deprescribing Potentially Inappropriate Medications in Older Adults Receiving Dialysis.

BACKGROUND: Potentially inappropriate medications, or medications that generally carry more risk of harm than benefit in older adults, are commonly prescribed to older adults receiving dialysis. Deprescribing, a systematic approach to reducing or stopping a medication, is a potential solution to limit potentially inappropriate medications use. Our objective was to identify clinicians and patient perspectives on factors related to deprescribing to inform design of a deprescribing program for dialysis clinics. METHODS: We conducted rapid qualitative analysis of semistructured interviews and focus groups with clinicians (dialysis clinicians, primary care providers, and pharmacists) and patients (adults receiving hemodialysis aged 65 years or older and those aged 55-64 years who were prefrail or frail) from March 2019 to December 2020. RESULTS: We interviewed 76 participants (53 clinicians [eight focus groups and 11 interviews] and 23 patients). Among clinicians, 24 worked in dialysis clinics, 18 worked in primary care, and 11 were pharmacists. Among patients, 13 (56%) were aged 65 years or older, 14 (61%) were Black race, and 16 (70%) reported taking at least one potentially inappropriate medication. We identified four themes (and corresponding subthemes) of contextual factors related to deprescribing potentially inappropriate medications: ( 1 ) system-level barriers to deprescribing (limited electronic medical record interoperability, time constraints and competing priorities), ( 2 ) undefined comanagement among clinicians (unclear role delineation, clinician caution about prescriber boundaries), ( 3 ) limited knowledge about potentially inappropriate medications (knowledge limitations among clinicians and patients), and ( 4 ) patients prioritize symptom control over potential harm (clinicians expect resistance to deprescribing, patient weigh risks and benefits). CONCLUSIONS: Challenges to integration of deprescribing into dialysis clinics included siloed health systems, time constraints, comanagement behaviors, and clinician and patient knowledge and attitudes toward deprescribing.

COVID-19 in the Community: Changes to Women's Mental Health, Financial Security, and Physical Activity.

Introduction: This study describes changes in the mental health, financial security, and physical activity levels of women in North Carolina during the COVID-19 pandemic. Methods: Data were collected from women aged 20-40 years receiving primary care at 2 health centers in North Carolina during 2020-2022. Surveys (N=127) evaluated changes in mental health, financial security, and physical activity during the COVID-19 pandemic. These outcomes were analyzed both descriptively and for association with sociodemographic factors using logistic regression. A subset of participants (n=46) participated in semistructured interviews. Interview transcripts were reviewed and evaluated for recurring themes by primary and secondary coders using a rapid-coding technique. Analysis was conducted in 2022. Results: Women surveyed were 28.4% non-Hispanic White, 38.6% non-Hispanic Black, and 33.1% Hispanic/Latina. Compared with reports before the pandemic, participants reported increased frustration or boredom (69.1%), loneliness (51.6%), anxiety (64.3%), depression (52.4%), and changed sleep patterns (68.3%). Increased alcohol and other recreational substance use were associated with race and ethnicity (p<0.05) after adjustment for other sociodemographic factors. Participants reported difficulty in paying for basic expenses (44.0%). Financial difficulties during COVID-19 were associated with non-Hispanic Black race and ethnicity, less education, and lower prepandemic household income. Data showed pandemic-associated reductions in mild (32.8%), moderate (39.5%), and strenuous (43.3%) exercise, with a correlation between increased depression and reduced mild exercise. Interviews identified themes including reduced activity while working remotely, lack of gym access, and reduced motivation for exercise. Conclusions: This mixed-methods study is one of the first to evaluate the mental health, financial security, and physical activity challenges women aged between 20 and 40 years in the southern U.S. faced during the COVID-19 pandemic.

Describing current use, barriers, and facilitators of patient portal messaging for research recruitment: Perspectives from study teams and patients at one institution.

Introduction: The electronic health record (EHR) and patient portal are used increasingly for clinical research, including patient portal recruitment messaging (PPRM). Use of PPRM has grown rapidly; however, best practices are still developing. In this study, we examined the use of PPRM at our institution and conducted qualitative interviews among study teams and patients to understand experiences and preferences for PPRM. Methods: We identified study teams that sent PPRMs and patients that received PPRMs in a 60-day period. We characterized these studies and patients, in addition to the patients' interactions with the PPRMs (e.g., viewed, responded). From these groups, we recruited study team members and patients for semi-structured interviews. A pragmatic qualitative inquiry framework was used by interviewers. Interviews were audio-recorded and analyzed using a rapid qualitative analysis exploratory approach. Results: Across ten studies, 35,037 PPRMs were sent, 33% were viewed, and 17% were responded to. Interaction rates varied across demographic groups. Six study team members completed interviews and described PPRM as an efficient and helpful recruitment method. Twenty-eight patients completed interviews. They were supportive of receiving PPRMs, particularly when the PPRM was relevant to their health. Patients indicated that providing more information in the PPRM would be helpful, in addition to options to set personalized preferences. Conclusions: PPRM is an efficient recruitment method for study teams and is acceptable to patients. Engagement with PPRMs varies across demographic groups, which should be considered during recruitment planning. Additional research is needed to evaluate and implement recommended changes by study teams and patients.

Clinician Perspectives on Managing Chronic Pain After Curative-Intent Cancer Treatment.

PURPOSE: Among cancer survivors who have completed curative-intent treatment, the high prevalence and adverse consequences of chronic pain are well documented. Yet, research on clinicians' experiences with and perspectives on managing chronic pain among cancer survivors is critically lacking. METHODS: We conducted semistructured interviews with 17 clinicians (six oncology, three palliative care, and eight primary care) affiliated with an academic medical center. Interview questions addressed clinicians' experiences with and perspectives on managing chronic pain (with or without opioid therapy) during the transition from active treatment to survivorship. A multidisciplinary team conducted content analysis of interview transcripts to identify and refine themes related to current practices and challenges in managing chronic pain in this context. RESULTS: Overall, clinicians perceived chronic pain to be relatively uncommon among cancer survivors. Identified challenges included a lack of clarity about which clinician (or clinicians) are best positioned to manage chronic pain among cancer survivors, and (relatedly) complexities introduced by long-term opioid management, with many clinicians describing this practice as outside their skill set. Additionally, although most clinicians recognized chronic pain as a biopsychosocial phenomenon, they described challenges with effectively managing psychosocial stressors, including difficulty accessing mental or behavioral health services for cancer survivors. CONCLUSION: Discovered challenges highlight unmet needs related to cancer survivor-clinician communication about chronic pain and the absence of a chronic pain management home for cancer survivors, including those requiring long-term opioid therapy. Research evaluating routine pain monitoring and accessible, tailored models of multimodal pain care in survivorship may help to address these challenges.

Modifiable Barriers and Facilitators for Breast Cancer Care: A Thematic Analysis of Patient and Provider Perspectives.

INTRODUCTION: We sought to examine patient and provider perspectives regarding modifiable contributors to breast cancer treatment and to assess perceptual alignment between these two groups. MATERIALS: Participants were women≥18 y with stage 0-IV breast cancer who received all oncologic care in a single health system and physicians and advanced practice providers who provided medical, radiation, or surgical oncology care for breast cancer. All completed ∼45-min semistructured interviews that were recorded and transcribed verbatim. A 5-stage approach to thematic analysis was conducted, with emergent themes and exemplar quotes placed into clinical, psychological, social/logistical, financial, and lifestyle categories using a multilevel conceptual framework. RESULTS: Eighteen patients (9 Black, 9 White, and median age 60 y) and 10 providers (6 physicians and 4 advanced practice providers) were interviewed from May to November 2018. Both patients and providers perceived suboptimal communication, parking and transportation, and competing family-caregiving responsibilities as modifiable barriers to care. Treatment costs were cited by patients as barriers that were inadequately addressed even with referrals to financial counselors, but providers did not raise the issue of cost unless prompted by patients and did not feel prepared to discuss the topic when it arose. Providers cited obesity as a barrier to treatment, a view not shared by patients. CONCLUSIONS: Several modifiable factors were recognized by both patients and providers as either promoting or detracting from treatment receipt, but there was also significant incongruence and asymmetry. Alignment of provider and patient perceptions regarding contributors to guideline-concordant care receipt could mitigate disparities in breast cancer treatment and outcomes.

Modifiable patient-reported factors associated with cancer-screening knowledge and participation in a community-based health assessment.

BACKGROUND: We sought to identify modifiable factors associated with cancer screening in a community-based health assessment. METHODS: 24 organizations at 47 community events in central North Carolina distributed a 91-item survey from April-December 2017. Responses about (1) interest in disease prevention, (2) lifestyle choices (e.g., diet, tobacco), and (3) perceptions of primary care access/quality were abstracted to examine their association with self-reported screening participation and knowledge about breast, prostate, and colorectal cancer. RESULTS: 2135/2315 participants (92%; 38.5% White, 38% Black, 9.9% Asian) completed screening questions. >70% of screen-eligible respondents reported guideline-concordant screening. Healthy dietary habits were associated with greater knowledge about breast and colorectal cancer screening; reporting negative attitudes about and barriers to healthcare were associated with less breast, prostate, and colorectal cancer screening. Having a place to seek medical care (a proxy for primary care access) was independently associated with being ∼5 times as likely to undergo colorectal screening (OR 4.66, 95% CI 1.58-13.79, all p < 0.05). CONCLUSIONS: In this diverse, community-based sample, modifiable factors were associated with screening engagement, highlighting opportunities for behavioral intervention.

Hidden Curriculum and the Demographic Stoicism That Keeps Women and Minorities Away From Radiology: A Mixed-Methods Study of Medical Students.

OBJECTIVE: To understand how women and historically underrepresented minority medical students perceive radiology as a potential career choice. METHODS: Medical students representing a broad spectrum of radiology exposure from a single institution were invited to participate in a mixed-methods study. Participants completed a 16-item survey about demographics and perceptions of radiology. Ten focus groups were administered to probe decision making regarding career selection. The themes influencing women and historically underrepresented minority students are presented. RESULTS: Forty-nine medical students, including 29 (59%) women and 17 (35%) underrepresented minorities, participated. Most participants (28 of 48, 58%) reported men outnumbered women in radiology. Female participants reported a lack of mentorship and role models as major concerns. Outreach efforts focused on the family-friendly nature of radiology were viewed as patronizing. Demographic improvements in the field were viewed as very slow. Forty-six percent (22 of 48) of participants indicated that radiology had a less underrepresented racial or ethnic workforce than other medical specialties. Minority participants especially noted a lack of radiology presence in mainstream media, so students have few preconceived biases. A failure to organically connect with the mostly White male radiologists because of a lack of shared background was a major barrier. Finally, participants described a hidden curriculum that pushes minority medical students away from specialty fields like radiology and toward primary care fields to address underserved communities and health care disparities. DISCUSSION: Women and historically underrepresented minority medical students perceive major barriers to choosing a career in radiology. Radiology departments must develop sophisticated multilevel approaches to improve diversity.

"You start feeling comfortable, you just start sharing:" A qualitative study of patient distress screening in Black and White patients with endometrial cancer.

OBJECTIVES: Black patients with endometrial cancer are less likely to express distress and receive referrals for support services compared to White patients. We aim to characterize patient perceptions of the National Comprehensive Cancer Network Distress Thermometer and Problem List (NCCN DT & PL), a common distress screening tool, among Black and White patients with endometrial cancer and determine strategies to improve equity in referral to appropriate support services. METHODS: We conducted semi-structured interviews with 15 Black and 15 White patients with endometrial cancer who reported varying levels of distress on the NCCN DT & PL. Interviews were audio-recorded, transcribed, evaluated through staged content analysis, and salient themes were compared by patient race. RESULTS: The NCCN DT & PL was generally considered understandable, however the word "distress" could be alienating to participants who considered their stress to be less "drastic." Black participants mentioned fewer negative emotions such as worry and sadness in describing distress and spoke more often of a positive outlook. Additionally, Black participants emphasized the importance of relationship-building with clinicians for open communication on the NCCN DT & PL and clinical encounter. Finally, participants were divided on whether they would alter the way they completed the NCCN DT & PL given more information on cut off scores for referrals, but generally expressed a desire for more direct offers of support services. CONCLUSIONS: Relationship-building, open communication around emotion, and longitudinal direct offers of support emerged as avenues to reduce inequities in referral to supportive services for patients with endometrial cancer.

Self-Perceived Barriers and Facilitators to Dietary Approaches to Stop Hypertension Diet Adherence Among Black Americans With Chronic Kidney Disease: A Qualitative Study.

OBJECTIVE: The Dietary Approaches to Stop Hypertension (DASH) eating plan improves hypertension in Black individuals and is associated with favorable chronic kidney disease (CKD) outcomes. Yet, adherence to DASH is low among US adults in general, particularly among Black Americans. We assessed perceptions about DASH, its cultural compatibility, and barriers and facilitators to DASH adherence in Black adults with CKD. DESIGN AND METHODS: We conducted focus groups and semistructured individual interviews involving 22 Black men and women with CKD Stages 3-4 from outpatient clinics at a US academic medical center. Transcripts of audio-recorded interviews were analyzed using thematic analysis. RESULTS: Among participants (2 focus groups [N = 8 and 5] and 9 individual interviews), 13 (59%) had CKD Stage 3, 13 (59%) were female, the median age was 61 years, and 19 (90%) had hypertension. After receiving information about DASH, participants perceived it as culturally compatible based on 3 emergent themes: (1) Black individuals already eat DASH-recommended foods ("Blacks eat pretty much like this"), (2) traditional recipes (e.g., southern or soul food) can be modified into healthy versions ("you can come up with decent substitutes to make it just as good"), and ( 3) diet is not uniform among Black individuals ("I can't say that I eat traditional"). Perceived barriers to DASH adherence included unfamiliarity with serving sizes, poor cooking skills, unsupportive household members, and high cost of healthy food. Eleven (52%) reported after paying monthly bills that they "rarely" or "never" had leftover money to purchase healthy food. Perceived facilitators included having local access to healthy food, living alone or with supportive household members, and having willpower and internal/external motivation for change. CONCLUSIONS: Black adults with CKD viewed DASH as a healthy, culturally compatible diet. Recognizing that diet in Black adults is not uniform, interventions should emphasize person-centered, rather than stereotypically culture-centered, approaches to DASH adherence.

Understanding the needs and perspectives of ovarian cancer patients when considering PARP inhibitor maintenance therapy: Findings from two online community events.

Objective: The online environment is an ideal setting to understand how many women seek, receive, and understand information about cancer treatment. The purpose of this study was to understand women's needs and information-seeking around Poly ADP ribose polymerase (PARP) inhibitors, an oral medication commonly prescribed as maintenance therapy at the conclusion of primary chemotherapy for ovarian cancer. Methods: We held online discussion events with two social media communities, #gyncsm social media on Twitter and the Smart Patients ovarian cancer community, in November 2020, to sample ovarian cancer patient perceptions of, and information seeking about PARP inhibitors. Focused questions were presented to both communities, with participants able to answer and elaborate upon these questions, as well as to add their own comments or topics. Qualitative content analysis was performed on the transcripts from the two online events. Results: A total of 254 unique tweets and 71 messages were generated from the Twitter and Smart Patients conversations, respectively. The majority of the content from these two events could be categorized into five major themes: (1) concerns about side effects, (2) expectations of benefit, (3) desire for more information regarding clinical trials, ) (4) desire to better understand the relationship between mutation status and PARP inhibitor effectiveness, and (5) financial toxicity. Misinformation was rarely identified. Conclusions: Women with ovarian cancer who are engaged in online patient communities have numerous educational needs regarding PARP inhibitors. Given the complexity of clinical research on PARP inhibitors, patients would likely benefit from patient-centered educational tools.

Association of caregiver attitudes with adolescent HPV vaccination in 13 southern US states.

Background and objectives:  HPV vaccination coverage is lower than that of other adolescent vaccines in the southern US. This study sought to characterize caregiver attitudes associated with adolescent HPV vaccination in the southern US and to inform interventions to promote HPV vaccination. Methods: From December 2019 - January 2020, caregivers of adolescents (ages 9-17 years) living in thirteen southern US states were recruited from a nationally-representative online survey panel. Caregivers (N = 1,105) completed a cross-sectional survey that assessed general adolescent vaccine attitudes as well as those associated with the HPV vaccine and HPV vaccination decision-making. The primary study outcome was adolescents' receipt of at least one dose of the HPV vaccine. Results: Caregivers with vaccinated adolescents had greater positive attitudes towards adolescent vaccines compared to caregivers of unvaccinated adolescents. Top three areas of concern among caregivers were related to vaccine ingredients, perceptions that adolescents receive too many vaccines, and worry about vaccine side effects. In multivariable regression models, positive attitudes towards the HPV vaccine and HPV vaccination decision-making strongly associated with HPV vaccination in addition to general adolescent vaccination attitudes. Caregivers' reported discomfort with discussing the topic of sex was predictive of lower vaccination uptake for older adolescents. Conclusions: Public health messaging in the southern US should be tailored to reduce concerns about vaccine safety and to communicate the importance of timely HPV vaccination. Campaigns that deliver information specific to the HPV vaccine and to support vaccination decision-making may be more effective than those delivering only general adolescent vaccination information at promoting on-time HPV vaccination.

Key stakeholder perspectives on challenges and opportunities for rural HPV vaccination in North and South Carolina.

The objective of this study was to identify factors at the individual, provider, and systems levels that serve as challenges or opportunities for increasing adolescent vaccination-including Human Papillomavirus (HPV) vaccination-in rural communities in the southern United States (US). As part of a broader study to increase HPV vaccine uptake in the southern US, we conducted in-depth interviews with vaccination stakeholders representing public health and education agencies in North Carolina (NC) and South Carolina (SC). Fourteen key stakeholders were recruited using purposive sampling to obtain insights into challenges and solutions to rural-urban disparities in HPV vaccination coverage. Stakeholders were also queried about their experiences and attitudes toward school-based vaccination promotion programs and campaigns. We used a rapid qualitative approach to analyze the data. Stakeholders identified factors at the individual, provider, and systems levels that serve as challenges to vaccination in rural communities. Similar to previous studies, stakeholders mentioned challenges with healthcare access and vaccine-related misconceptions that pose barriers to HPV vaccination for rural residents. Systems-level challenges identified included limited access to high-speed internet in rural areas that may impact providers' ability to interface with state-level digital systems such as the vaccination registry. Stakeholders identified a number of opportunities to increase HPV vaccination coverage, including through school-based health promotion programs. Stakeholders strongly supported school-based programs and approaches to strengthen confidence and demand for HPV vaccination and to help address persistent social determinants and system level factors that pose challenges to HPV vaccination coverage in many rural areas.

Quality of Life Associated with Open vs Minimally Invasive Pancreaticoduodenectomy: A Prospective Pilot Study.

BACKGROUND: This prospective study was designed to compare quality of life (QoL) among patients who underwent open (O-PD) vs minimally invasive pancreaticoduodenectomy (MI-PD), using a combination of validated qualitative and quantitative methodologies. STUDY DESIGN: From 2017 to 2019, patients scheduled for pancreaticoduodenectomy (PD) were enrolled and presented with Functional Assessment of Cancer Therapy-Hepatobiliary surveys preoperatively, before discharge, at first postoperative visit and approximately 3 to 4 months after operation ("3 months"). Longitudinal plots of median QoL scores were used to illustrate change in each score over time. In a subset of patients, content analysis of semistructured interviews at postoperative time points (1.5 to 6 months after operation) was conducted. RESULTS: Among 56 patients who underwent PD, 33 had an O-PD (58.9%). Physical and functional scores decreased in the postoperative period but returned to baseline by 3 months. No significant differences were found in any domains of QoL at baseline and in the postoperative period between patients who underwent O-PD and MI-PD. Qualitative findings were concordant with quantitative data (n = 14). Patients with O-PD and MI-PD reported similar experiences with complications, pain, and wound healing in the postoperative period. Approximately half the patients in both groups reported "returning to normal" in the 6-month postoperative period. A total of 4 patients reported significant long-term issues with physical and functional well-being. CONCLUSIONS: Using a novel combination of qualitative and quantitative analyses in patients undergoing PD, we found no association between operative approach and QoL in patients who underwent O-PD vs MI-PD. Given the increasing use of minimally invasive techniques for PD and the steep learning curve associated with these techniques, continued assessment of patient benefit is critical.

Effects of Smoking Reduction and Cessation on Birth Outcomes in a Scheduled Gradual Reduction Cessation Trial.

INTRODUCTION: Smoking during pregnancy can affect infant birthweight. We tested whether an intervention that promoted scheduled gradual reduction improved birth outcomes among pregnant women who smoked. We also examined race differences in birth outcomes. METHODS: We conducted a 2-arm randomized controlled trial where pregnant women who smoked received either SMS text-delivered scheduled gradual smoking reduction (SGR) program plus support texts or support messages only throughout their pregnancy. The outcomes for this paper were birth outcomes including birth weight and gestational age obtained from chart review. Analyses were conducted using chi-square and t-tests in SAS. RESULTS: We approached 2201 pregnant women with smoking history. Of the 314 women recruited into the study, 290 completed a medical release form (92%). We did not find any significant differences in birth outcomes by arm or race. The majority of participants reduced smoking by the 80%. Women who reduced more than 50% of their baseline cigarettes per day had a birth weight increase of 335 g compared to those that did not (p = 0.05). The presence of alcohol/drug use in prenatal visit notes was associated with low infant birth weight (p = 0.05). DISCUSSION: The scheduled gradual reduction intervention did not improve birth outcomes. Additional research is needed to help improve birth outcomes for pregnant women who engage in tobacco and illicit substance use. CLINICAL TRIAL #: NCT01995097.

Evaluating fitness-for-use of electronic health records in pragmatic clinical trials: reported practices and recommendations.

OBJECTIVE: To empirically explore how pragmatic clinical trials (PCTs) that used real-world data (RWD) assessed study-specific fitness-for-use. METHODS: We conducted interviews and surveys with PCT teams who used electronic health record (EHR) data to ascertain endpoints. The survey cataloged key concerns about RWD, activities used to assess data fitness-for-use, and related barriers encountered by study teams. Patterns and commonalities across trials were used to develop recommendations for study-specific fitness-for-use assessments. RESULTS: Of 15 invited trial teams, 7 interviews were conducted. Of 31 invited trials, 15 responded to the survey. Most respondents had prior experience using RWD (93%). Major concerns about EHR data were data reliability, missingness or incompleteness of EHR elements, variation in data quality across study sites, and presence of implausible or incorrect values. Although many PCTs conducted fitness-for-use activities (eg, data quality assessments, 11/14, 79%), less than a quarter did so before choosing a data source. Fitness-for-use activities, findings, and resulting study design changes were not often publically documented. Overall costs and personnel costs were barriers to fitness-for-use assessments. DISCUSSION: These results support three recommendations for PCTs that use EHR data for endpoint ascertainment. Trials should detail the rationale and plan for study-specific fitness-for-use activities, conduct study-specific fitness-for-use assessments early in the prestudy phase to inform study design changes before the trial begins, and share results of fitness-for-use assessments and description of relevant challenges and facilitators. CONCLUSION: These recommendations can help researchers and end-users of real-world evidence improve characterization of RWD reliability and relevance in the PCT-specific context.

A web-based personalized decision support tool for patients diagnosed with ductal carcinoma in situ: development, content evaluation, and usability testing.

PURPOSE: Patients diagnosed with ductal carcinoma in situ (DCIS) face trade-offs when deciding among different treatments, including surgery, radiation, and endocrine therapy. A less chosen option is active monitoring. While evidence from clinical trials is not yet available, observational studies show comparable results for active monitoring and immediate treatment on cancer outcomes in select subgroups of patients. We developed and tested a web-based decision support tool (DST) to help patients explore current knowledge about DCIS and make an informed choice. METHODS: The DST, an interactive web application, was informed by literature reviews and formative work with patients, breast surgeons, and health communication experts. We conducted iterative interviews to evaluate the DST content among women with and without a history of breast cancer, as well as breast cancer experts. For usability testing, we conducted an online survey among women with and without a history of breast cancer. RESULTS: For content evaluation, 5 women with and 10 women without a history of DCIS were interviewed. The sample included 11 White and 4 non-White women, with a mean age of 64 years. The expert sample consisted of 5 attendings and a physician assistant. The feedback was used to add, clarify, or reorganize information in the DST. For usability testing, 22 participants with a mean age of 61 years were recruited including 15 White and 7 Black women and 6 women with a history of DCIS. The mean usability score was 3.7 out of 5. Most participants (86%) found that the DST provided unbiased information about treatments. To improve usability, we reduced the per-page content and added navigation cues. CONCLUSION: Content and usability evaluation showed that the DST helps patients explore trade-offs of active monitoring and immediate treatment. By adopting a personalized approach, the tool will enable informed decisions aligned with patients' values and expectations.