Michele Halyard - Academia.edu (original) (raw)

Papers by Michele Halyard

Research paper thumbnail of Patient-reported data collection in clinical practice: challenges, opportunities, and insights

Research paper thumbnail of Implementing patient-reported outcomes assessment in clinical practice: a review of the options and considerations

Quality of Life Research, 2011

Purpose While clinical care is frequently directed at making patients ''feel better,'' patients' ... more Purpose While clinical care is frequently directed at making patients ''feel better,'' patients' reports on their functioning and well-being (patient-reported outcomes [PROs]) are rarely collected in routine clinical practice. The International Society for Quality of Life Research (ISOQOL) has developed a User's Guide for Implementing Patient-Reported Outcomes Assessment in Clinical Practice. This paper summarizes the key issues from the User's Guide. Methods Using the literature, an ISOQOL team outlined considerations for using PROs in clinical practice; options for designing the intervention; and strengths, weaknesses, and resource requirements associated with each option. Results Implementing routine PRO assessment involves a number of methodological and practical decisions, including (1) identifying the goals for collecting PROs in clinical practice, (2) selecting the patients, setting, and timing of assessments, (3) determining which questionnaire(s) to use, (4) choosing a mode for administering and scoring the questionnaire, (5) designing processes for reporting results, (6) identifying aids to facilitate score interpretation, (7) developing strategies for responding to issues identified by the questionnaires, and (8) evaluating the impact of the PRO intervention on the practice. Conclusions Integrating PROs in clinical practice has the potential to enhance patient-centered care. The online version of the User's Guide will be updated periodically. This paper is produced on behalf of the International Society for Quality of Life Research (ISOQOL). All authors are members of ISOQOL. All authors participated in writing the paper and reviewing the drafts. The manuscript was reviewed and approved by the ISOQOL Board of Directors as an ISOQOL publication and does not reflect an endorsement of the ISOQOL membership.

Research paper thumbnail of User's Guide to Implementing Patient-Reported Outcomes Assessment in Clinical Practice

Research paper thumbnail of ACR Appropriateness Criteria® Locally Advanced Breast Cancer

The Breast Journal, 2011

Locally advanced breast cancer (LABC) is a disease that is heterogeneous in its presentation, pot... more Locally advanced breast cancer (LABC) is a disease that is heterogeneous in its presentation, potentially curable, and generally necessitating multidisciplinary management. Radiation therapy (RT) plays an important role in the management of LABC. The integration of radiation with surgery, chemotherapy, and sometimes breast reconstruction can be complex. The American College of Radiology Appropriateness Criteria Breast Committee aims to provide guidance for the management of a variety of LABC cases. The American College of Radiology Appropriateness Criteria is evidencebased guidelines for specific clinical conditions that are reviewed every 2 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer-reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances where evidence is either lacking or not definitive, expert opinion may be used to recommend imaging or treatment. n

Research paper thumbnail of Abstract PS2-41: Supplemental contrast enhanced mammography screening of women with elevated risk of breast cancer

Cancer Research

Objective and Rationale: To investigate the utility of screening Contrast Enhanced Mammography (C... more Objective and Rationale: To investigate the utility of screening Contrast Enhanced Mammography (CEM) imaging as a supplemental screening tool in women at elevated risk for breast cancer. Materials and Methods: This prospective, single institution, IRB approved observational study was conducted in asymptomatic women 35 years of age or older who were deemed at elevated risk of breast cancer, defined as IBIS v.8.0 lifetime risk of breast cancer score >15% or a prior personal history of breast cancer. Enrollment started in January 2019 and is on-going. An interim data analysis was performed. Women were invited to undergo supplemental CEM screening within 180 days of negative (BI-RADS 1 or 2) conventional 2D/3D screening mammography (MG). Patients with prior screening MBI, ultrasound or MR imaging within 12 months were excluded from study participation. Outcome measures were supplemental cancer detection rates, sensitivity, specificity, positive predictive value, and negative predicti...

Research paper thumbnail of Incorporating Validated Measures for Patient-reported Outcomes in Clinical Practice

Patient-reported outcomes (PROs) reflect the subjective experience of the patient with respect to... more Patient-reported outcomes (PROs) reflect the subjective experience of the patient with respect to their well-being and quality of life. Historically there have been barriers to routine assessment of PROs, including methodological challenges and clinical realities. This paper presents three approaches that have capitalized on clinical realities and technological advances to integrate PROs into an improved case management approach to health care. Empirical data indicate that PROs are prognostic for patient survival and can have profound impact on the course and success of treatment. Keywords—Quality of life, patient-reported outcomes, webbased system, case management.

Research paper thumbnail of CMET-47. Clinical Evaluation of Fitness to Drive in Patients with Brain Metastases

Neuro-Oncology, 2018

NEURO-ONCOLOGY • NOVEMBER 2018 ratio. RESULTS: Forty cases were included for analysis, describing... more NEURO-ONCOLOGY • NOVEMBER 2018 ratio. RESULTS: Forty cases were included for analysis, describing operative (14) and non-operative (26) management. Median time from initial MCC diagnosis to CNS involvement was 17.0-mos (IQR 10.5-26.5), and most patients had a single BM (62.5%). Management of intracranial disease included RT (84.2%), systemic therapy (59.5%) and surgical resection (35%). Operative management was associated with a lower intracranial burden of disease (BoD, single BM: op 92.9% vs. non-op 46.2%, p=0.004), but similar systemic BoD. Median OS was longer in patients treated with neurosurgery (73-mos, 95%CI:31-115 vs. 25-mos, 95%CI:17-44, p ‹ 0.001). Both neurosurgery (HR 0.18, 95%CI:0.06-0.54, p=0.002) and having a single BM (multiple BM or leptomeningeal disease: HR 2.51, 95%CI:1.12-5.6, p=0.03) conferred an OS benefit on risk-unadjusted analysis. On multivariable analysis, only neurosurgical resection was an independent predictor of OS (HR 0.16, 95%CI:0.04-0.59, p=0.006), controlling for age, BoD and RT. Systemic therapy and RT were not associated with OS. CONCLUSIONS: Resection of MCC BM may confer a survival benefit relative to non-operative management given appropriate patient selection. Prospective investigation of multimodal management of neurometastatic MCC is warranted, especially given the promise of new immunotherapy agents in treating MCC.

Research paper thumbnail of Choosing wisely after publication of level I evidence in breast cancer radiotherapy

Breast cancer (Dove Medical Press), 2018

Recent trials in early-stage breast cancer support hypofractionated whole-breast radiotherapy (WB... more Recent trials in early-stage breast cancer support hypofractionated whole-breast radiotherapy (WBRT) as part of breast-conserving therapy (BCT). Evidence also suggests that radiotherapy (RT) omission may be reasonable for some patients over 70 years. Among radiation-delivery techniques, intensity-modulated RT (IMRT) is more expensive than 3-dimensional conformal RT (3DCRT). Based on this evidence, in 2013, the American Society for Radiation Oncology (ASTRO) recommended hypofractionated schedules for women aged ≥50 years with early-stage breast cancer and avoiding routine use of IMRT for WBRT. To assess response to level I evidence and adherence to ASTRO recommendations, we evaluated the pattern of RT use for early-stage breast cancer at our National Comprehensive Cancer Network institution from 2006 to 2008 and 2011 to 2013 and compared the results with national trends. Data from a prospective database were extracted to include patients treated with BCT, aged ≥50 years, with histolo...

Research paper thumbnail of Patient-reported distress and survival among patients receiving definitive radiation therapy

Advances in radiation oncology

Patient-reported distress (PRD) has not been well assessed in association with survival after rad... more Patient-reported distress (PRD) has not been well assessed in association with survival after radiation therapy (RT). The aims of this study were to evaluate the association between PRD level and survival after definitive RT and to identify the main causes of distress in definitive RT patients. A total of 678 consecutive patients receiving definitive RT at our institution from April 2012 through May 2015 were included. All patients answered a PRD questionnaire that contained 30 items related to possible causes of distress, which could be rated from 1 (no distress) to 5 (high distress). Additionally, patients were asked to rate their overall distress level from 0 (no distress) to 10 (extreme distress). This overall distress level was our primary patient-reported distress measure and was examined as a continuous variable and as a categorical variable with 3 PRD levels (low, 0-3 [n = 295]; moderate, 4-6 [n = 222]; and high, 7-10 [n = 161]). As a continuous variable in multivariable Cox...

Research paper thumbnail of Outcomes and Patterns of Failure for Sinonasal Undifferentiated Carcinoma (SNUC): The Mayo Clinic Experience

International Journal of Radiation Oncology*Biology*Physics, 2016

comparison of FAK expression in central cells of recurrent and nonrecurrent cases of ameloblastom... more comparison of FAK expression in central cells of recurrent and nonrecurrent cases of ameloblastoma (PZ.3692) was found to be insignificant. Conclusion: FAK expression in odontogenic epithelium of ameloblastoma suggests its role in the locally aggressive behavior. FAK could be responsible for cell invasion and migration in ameloblastoma.

Research paper thumbnail of The Effect of Message Framing on African American Women’s Intention to Participate in Health-Related Research

Journal of Health Communication, 2016

This study examined the effect of message framing on African American women's intention to partic... more This study examined the effect of message framing on African American women's intention to participate in health-related research and actual registration in ResearchMatch (RM), a diseaseneutral, national volunteer research registry. A community-engaged approach was used involving collaboration between an academic medical center and a volunteer service organization formed by professional women of color. A self-administered survey which contained an embedded message framing manipulation was distributed to over 2,000 African American women attending the 2012 National Assembly of The Links, Incorporated. A total of 391 surveys were completed (187 containing the gain-framed message and 194 containing the loss-framed message). The majority (57%) of women expressed favorable intentions to participate in health-related research, and 21% subsequently enrolled in RM. The effect of message framing on intention was moderated by selfefficacy; there was no effect of message framing on RM registration, however those with high selfefficacy were over two times as likely as those with low self-efficacy to register as a potential study volunteer in RM (OR=2.62; 1.29,5.33). This investigation makes theoretical and practical

Research paper thumbnail of Outcomes of patients with loco-regionally recurrent or new primary squamous cell carcinomas of the head and neck treated with curative intent reirradiation at Mayo Clinic

Radiation oncology (London, England), Jan 9, 2016

We reviewed outcomes of patients with loco-regionally recurrent (LRR) or new primary (NP) squamou... more We reviewed outcomes of patients with loco-regionally recurrent (LRR) or new primary (NP) squamous cell carcinoma of the head and neck (SCCHN) treated at our institution with reirradiation (RRT). Patients received definitive RRT (DRRT) or post-operative RRT following salvage surgery (PRRT) from 2003 to 2011. Measured survival outcomes included loco-regional relapse free survival (LRFS) and overall survival (OS). Among 81 patients (PRRT, 42; DRRT, 39), median PRRT and DRRT doses were 60 Gy (12-70 Gy) and 69.6 Gy (48-76.8 Gy). The majority of patients received IMRT-based RRT (n = 77, 95 %). With median follow-up of 78.1 months (95 % CI, 56-96.8 months), 2-year OS was 53 % with PRRT and 48 % with DRRT (p = 0.12); 23 % of patients were alive at last follow-up. LRFS at 2 years was 60 %, and did not differ significantly between PRRT and DRRT groups. A trend toward inferior LRFS was noted among patients receiving chemotherapy with RRT versus RRT alone (p = 0.06). Late serious toxicities we...

Research paper thumbnail of Prevalent Health Concerns Among African American Women Belonging to a National Volunteer Service Organization (The Links, Incorporated)

Journal of Racial and Ethnic Health Disparities, 2015

Objective-African American women bear a disproportionate burden of cardiovascular disease (CVD) a... more Objective-African American women bear a disproportionate burden of cardiovascular disease (CVD) and cancer. The purpose of this study was to identify prevalent health concerns among African American women who are members of The Links, Incorporated (Links), a large national service organization with health programming for communities of color. Methods-Survey data (n=391) were collected during the 2012 Links National Assembly. Twenty-six health issues were presented within five groups: cancer, CVD, pulmonary disease, chronic conditions, and behavioral health. For each issue, women indicated if it was a concern for "you/your family" or "the African American community" via check-boxes. Differences in the proportions for "you/your family" and "the African American community" were evaluated using the McNemar test.

Research paper thumbnail of Radiotherapy concurrent with trastuzumab is well tolerated in the adjuvant treatment of women with HER2-positive breast cancer: cardiac safety data from the NCCTG N9831 study

European Journal of Cancer Supplements, 2006

Research paper thumbnail of Black Men’s Perceptions and Knowledge of Diabetes: a Church-Affiliated Barbershop Focus Group Study

Journal of Racial and Ethnic Health Disparities, 2015

Background Diabetes is the seventh leading cause of death in the USA and disproportionately affec... more Background Diabetes is the seventh leading cause of death in the USA and disproportionately affects racial and ethnic minorities. These disparities persist despite educational efforts to reduce the prevalence of diabetes. Receptiveness of educational efforts for Black men needs to be studied. Objective This study assesses Black men's receptiveness to a barbershop-based program focused on diabetes prevention and awareness in a church-affiliated barbershop in Rochester, Minnesota. Methods The pastor and barber of a church-affiliated barbershop and academic medical researchers designed a community-engaged research study to determine Black men's perception of diabetes. Recruitment for the 90-minute focus group included flyers (n=60), email, and in-person. Units of analysis included focus group audio recording, transcripts, and field notes. Using traditional content analysis, we categorized data into themes and subthemes. Results Thirteen Black men participated (group 1, n=6; group 2, n=7) having a mean age of 40.3 years (range 19 to 65), and employed full-time (77 %). Themes included diabetes prevention, treatment, prevalence, risks, and health education. Participants identified diet and exercise as essential components of diabetes prevention. Additionally, participants mentioned J

Research paper thumbnail of Angiosarcoma of the Scalp and Face

JAMA Otolaryngology–Head & Neck Surgery, 2015

and optimal treatment are unknown for angiosarcoma, an aggressive malignant tumor that affects va... more and optimal treatment are unknown for angiosarcoma, an aggressive malignant tumor that affects vascular endothelial cells and can be mistaken for benign lesions such as hemangioma. OBJECTIVE To determine the treatment outcomes of patients with angiosarcoma of the face or scalp treated with a combination of surgery, radiation therapy, and/or chemotherapy. DESIGN, SETTING, AND PARTICIPANTS Retrospective study of 55 patients with angiosarcoma of the face or scalp treated between January 1, 1973, and December 31, 2012, at a tertiary-care academic medical institution. INTERVENTIONS Surgery, radiation therapy, and/or chemotherapy. MAIN OUTCOMES AND MEASURES Locoregional control (LRC), recurrence-free survival (RFS), and overall survival (OS). RESULTS Fifty-five patients had angiosarcoma localized to the face or scalp. Forty of these patients (73%) received a combination of surgery, radiation therapy, and/or chemotherapy. Eight patients (15%) were treated with surgery alone, 1 (2%) with radiation alone, 5 (9%) with chemotherapy alone, and 1 (2%) with observation alone. Median (range) follow-up for surviving patients was 25.2 (4.7-227.1) months. Five-year LRC, RFS, and OS (95% CI) were 18% (7%-32%), 16% (6%-31%), and 38% (21%-54%), respectively. Of 36 patients with failed treatment, 34 had failure in a local and/or regional site. On univariate analysis, the use of multimodality therapy (vs no multimodality therapy) was associated with higher 5-year LRC (95% CI) (20% [3%-37%] vs 11% [0%-29%]; P = .04), higher RFS (19% [2%-36%] vs 10% [0%-27%]; P = .02), and higher OS (46% [26%-66%] vs 16% [0%-43%]; P = .04). Age 70 years or older (vs <70 years) was associated with lower 5-year LRC (95% CI) (5% [0%-14%] vs 48% [23%-74%]; P = .02) and lower RFS (5% [0%-13%] vs 49% [24%-75%]; P = .04). Radiation therapy (vs no radiation therapy) was associated with higher 5-year LRC (95% CI) (20% [3%-36%] vs 12% [0%-32%]; P = .02) and higher RFS (19% [2%-35%] vs 12% [0%-31%]; P = .004). On multivariable analysis, age younger than 70 years (vs Ն70 years) was associated with improved 5-year LRC (95% CI) (48% [23%-74%] vs 5% [0%-14%]; P = .03) and RFS (49% [24%-75%] vs 49% [24%-75%]; P = .04). CONCLUSIONS AND RELEVANCE Multimodality therapy for angiosarcoma is associated with improved LRC, RFS, and OS. Younger patients with resectable disease undergoing multimodality therapy for angiosarcoma had the best clinical outcomes.

Research paper thumbnail of Assessment of patient-reported measures of bowel function before and after pelvic radiotherapy: an ancillary study of the North Central Cancer Treatment Group study N00CA

Supportive Care in Cancer, 2012

Purpose-The Bowel Function Questionnaire (BFQ) has been used in clinical trials to assess symptom... more Purpose-The Bowel Function Questionnaire (BFQ) has been used in clinical trials to assess symptoms during and after pelvic radiotherapy (RT). This study evaluated the importance of symptoms in the BFQ from a patient perspective. Methods-Patients reported presence or absence of symptoms and rated importance of symptoms at baseline, 4 weeks after completion of pelvic RT, and 12 and 24 months after RT. The BFQ measured overall quality of life (QOL) and symptoms of nocturnal bowel movements, incontinence, clustering, need for protective clothing, inability to differentiate stool from gas, liquid bowel movements, urgency, cramping, and bleeding. Bowel movement frequency also was recorded. A content validity questionnaire was used to rate symptoms as "not very important," "moderately unimportant," "neutral," "moderately important," or "very important." Results-Most of the 125 participating patients rated all symptoms as moderately or very important. Generally, patients gave similar ratings for symptom importance at all study points, and ratings were independent of whether the patient experienced the symptom. Measures of greatest importance (moderately or very important) at baseline were ability to control bowel movements (94%), not having to wear protective clothing (90%), and not having rectal bleeding (94%). With the exception of need for protective clothing, the presence of a symptom at 4 weeks was associated with significantly worse QOL (P<.01 for all). Conclusions-The BFQ has excellent content validity. Patients rated most symptoms as moderately or very important, indicating the BFQ is an appropriate tool for symptom assessment during and after pelvic RT.

Research paper thumbnail of Prognostic factors in Merkel cell carcinoma: Analysis of 240 cases

Journal of the American Academy of Dermatology, 2013

Background: Knowledge regarding behavior of and prognostic factors for Merkel cell carcinoma (MCC... more Background: Knowledge regarding behavior of and prognostic factors for Merkel cell carcinoma (MCC) is limited. Objective: We sought to further understand the characteristics, behavior, prognostic factors, and optimal treatment of MCC. Methods: A multicenter, retrospective, consecutive study of patients with known primary MCC was completed. Overall survival and survival free of locoregional recurrence were calculated and statistical analysis of characteristics and outcomes was performed. Results: Among the 240 patients, the mean age at diagnosis was 70.1 years, 168 (70.0%) were male, and the majority was Caucasian. The most common location was head and neck (111, 46.3%). Immunosuppressed patients had significantly worse survival, with an overall 3-year survival of 43.4% compared with 68.1% in immunocompetent patients. In our study, patients with stage II disease had improved overall survival versus those with stage I disease, in a statistically significant manner. Patients with stage III disease had significantly worse survival compared with stage I and with stage II. Primary tumor size did not predict nodal involvement. Conclusion: The data presented represent one of the largest series of primary MCC in the literature and confirm that MCC of all sizes has metastatic potential, supporting sentinel lymph node biopsy for all primary MCC. Because of the unpredictable natural history of MCC, we recommend individualization of care based on the details of each patient's tumor and clinical presentation.

Research paper thumbnail of Phase III, Double-Blind Study of Depot Octreotide Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy: Results of North Central Cancer Treatment Group N00CA

Journal of Clinical Oncology, 2008

PurposeTo assess the effectiveness of depot octreotide for the prevention of diarrhea during pelv... more PurposeTo assess the effectiveness of depot octreotide for the prevention of diarrhea during pelvic radiation therapy.Patients and MethodsPatients receiving pelvic radiation therapy (planned minimum dose, 45 Gy; 1.7 to 2.1 Gy daily) were eligible for the study. From May 10, 2002, through October 14, 2005, 125 patients were randomly allocated in a double-blind fashion to receive octreotide (100 μg, administered subcutaneously on day 1, followed by depot octreotide, 20 mg, administered intramuscularly on days 2 and 29; n = 62) or to receive a placebo (n = 63).ResultsGrade 0, 1, 2, and 3 diarrhea were observed in 18%, 31%, 31%, and 21% of patients in the octreotide arm, respectively, and in 25%, 32%, 22%, and 21% of patients in the placebo arm, respectively (P = .64). Grade 0, 1, 2, and 3 abdominal cramps were observed in 32%, 45%, 21%, and 2% of patients receiving octreotide, respectively, and in 51%, 24%, 21%, and 5% of patients receiving the placebo, respectively (P = .053). Some pa...

Research paper thumbnail of Reply to N. Magne et al

Journal of Clinical Oncology, 2009

We thank Magne et al for their thoughtful comments. The issue of cardiac toxicity from trastuzuma... more We thank Magne et al for their thoughtful comments. The issue of cardiac toxicity from trastuzumab used in combination with radiation therapy (RT) for breast cancer remains an important one as women continue to be treated with both of these modalities. We emphasized in our work the need for longer follow-up in these patients treated with both trastuzumab and RT to determine whether our findings of lack of increased cardiac toxicity remain true over a greater length of time. Often cardiac manifestations of RT may not manifest until a decade or more after therapy. We performed two analyses to date evaluating cardiac toxicity acutely up to 14 months after commencement of RT, including the current analysis with a median follow-up of 3.7 years. Future analysis of is planned in the future given the known possibility of late occurrences of cardiac toxicity from RT in breast cancer treatment. Long-term monitoring of ejection fraction and of clinical events for at least 10 additional years from study entry is planned. We agree that great attention must be given to RT planning parameters relative to all critical normal structures that pose a risk for adverse events. In our trial, RT treatment planning details were not collected. Therefore, we are unable to comment on the cardiac volume irradiated in these patients. When our study was developed more than a decade ago, some RT techniques for internal mammary irradiation were known to be associated with greater coincident irradiation of the heart and with cardiac mortality. We were in uncharted territory at that time, so our approach was to prohibit irradiation of the internal mammary nodes in order to minimize the volume of heart irradiated as a safety precaution. More recently, some studies do suggest that patients treated in the older RT era experienced excess cardiac morbidity compared with those treated with more modern techniques where the irradiated cardiac volume is reduced. The use of more modern radiation treatment planning techniques, including three-dimensional computed tomography– based tools, has aided in cardiac sparing in breast cancer therapy. However, additional assessment of these more modern RT techniques, including those used in combination with newer systemic chemotherapeutic agents, is needed to assess the incidence of long-term development of cardiac issues. Despite the lack of longer-term information, we maintain that our recent study provides some assurance that the concurrent administration of RT and trastuzumab is associated with a safety profile that supports its use in contemporary practice. It is imperative that long-term analysis is conducted, and we, indeed, value the need for additional follow-up.

Research paper thumbnail of Patient-reported data collection in clinical practice: challenges, opportunities, and insights

Research paper thumbnail of Implementing patient-reported outcomes assessment in clinical practice: a review of the options and considerations

Quality of Life Research, 2011

Purpose While clinical care is frequently directed at making patients ''feel better,'' patients' ... more Purpose While clinical care is frequently directed at making patients ''feel better,'' patients' reports on their functioning and well-being (patient-reported outcomes [PROs]) are rarely collected in routine clinical practice. The International Society for Quality of Life Research (ISOQOL) has developed a User's Guide for Implementing Patient-Reported Outcomes Assessment in Clinical Practice. This paper summarizes the key issues from the User's Guide. Methods Using the literature, an ISOQOL team outlined considerations for using PROs in clinical practice; options for designing the intervention; and strengths, weaknesses, and resource requirements associated with each option. Results Implementing routine PRO assessment involves a number of methodological and practical decisions, including (1) identifying the goals for collecting PROs in clinical practice, (2) selecting the patients, setting, and timing of assessments, (3) determining which questionnaire(s) to use, (4) choosing a mode for administering and scoring the questionnaire, (5) designing processes for reporting results, (6) identifying aids to facilitate score interpretation, (7) developing strategies for responding to issues identified by the questionnaires, and (8) evaluating the impact of the PRO intervention on the practice. Conclusions Integrating PROs in clinical practice has the potential to enhance patient-centered care. The online version of the User's Guide will be updated periodically. This paper is produced on behalf of the International Society for Quality of Life Research (ISOQOL). All authors are members of ISOQOL. All authors participated in writing the paper and reviewing the drafts. The manuscript was reviewed and approved by the ISOQOL Board of Directors as an ISOQOL publication and does not reflect an endorsement of the ISOQOL membership.

Research paper thumbnail of User's Guide to Implementing Patient-Reported Outcomes Assessment in Clinical Practice

Research paper thumbnail of ACR Appropriateness Criteria® Locally Advanced Breast Cancer

The Breast Journal, 2011

Locally advanced breast cancer (LABC) is a disease that is heterogeneous in its presentation, pot... more Locally advanced breast cancer (LABC) is a disease that is heterogeneous in its presentation, potentially curable, and generally necessitating multidisciplinary management. Radiation therapy (RT) plays an important role in the management of LABC. The integration of radiation with surgery, chemotherapy, and sometimes breast reconstruction can be complex. The American College of Radiology Appropriateness Criteria Breast Committee aims to provide guidance for the management of a variety of LABC cases. The American College of Radiology Appropriateness Criteria is evidencebased guidelines for specific clinical conditions that are reviewed every 2 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer-reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances where evidence is either lacking or not definitive, expert opinion may be used to recommend imaging or treatment. n

Research paper thumbnail of Abstract PS2-41: Supplemental contrast enhanced mammography screening of women with elevated risk of breast cancer

Cancer Research

Objective and Rationale: To investigate the utility of screening Contrast Enhanced Mammography (C... more Objective and Rationale: To investigate the utility of screening Contrast Enhanced Mammography (CEM) imaging as a supplemental screening tool in women at elevated risk for breast cancer. Materials and Methods: This prospective, single institution, IRB approved observational study was conducted in asymptomatic women 35 years of age or older who were deemed at elevated risk of breast cancer, defined as IBIS v.8.0 lifetime risk of breast cancer score >15% or a prior personal history of breast cancer. Enrollment started in January 2019 and is on-going. An interim data analysis was performed. Women were invited to undergo supplemental CEM screening within 180 days of negative (BI-RADS 1 or 2) conventional 2D/3D screening mammography (MG). Patients with prior screening MBI, ultrasound or MR imaging within 12 months were excluded from study participation. Outcome measures were supplemental cancer detection rates, sensitivity, specificity, positive predictive value, and negative predicti...

Research paper thumbnail of Incorporating Validated Measures for Patient-reported Outcomes in Clinical Practice

Patient-reported outcomes (PROs) reflect the subjective experience of the patient with respect to... more Patient-reported outcomes (PROs) reflect the subjective experience of the patient with respect to their well-being and quality of life. Historically there have been barriers to routine assessment of PROs, including methodological challenges and clinical realities. This paper presents three approaches that have capitalized on clinical realities and technological advances to integrate PROs into an improved case management approach to health care. Empirical data indicate that PROs are prognostic for patient survival and can have profound impact on the course and success of treatment. Keywords—Quality of life, patient-reported outcomes, webbased system, case management.

Research paper thumbnail of CMET-47. Clinical Evaluation of Fitness to Drive in Patients with Brain Metastases

Neuro-Oncology, 2018

NEURO-ONCOLOGY • NOVEMBER 2018 ratio. RESULTS: Forty cases were included for analysis, describing... more NEURO-ONCOLOGY • NOVEMBER 2018 ratio. RESULTS: Forty cases were included for analysis, describing operative (14) and non-operative (26) management. Median time from initial MCC diagnosis to CNS involvement was 17.0-mos (IQR 10.5-26.5), and most patients had a single BM (62.5%). Management of intracranial disease included RT (84.2%), systemic therapy (59.5%) and surgical resection (35%). Operative management was associated with a lower intracranial burden of disease (BoD, single BM: op 92.9% vs. non-op 46.2%, p=0.004), but similar systemic BoD. Median OS was longer in patients treated with neurosurgery (73-mos, 95%CI:31-115 vs. 25-mos, 95%CI:17-44, p ‹ 0.001). Both neurosurgery (HR 0.18, 95%CI:0.06-0.54, p=0.002) and having a single BM (multiple BM or leptomeningeal disease: HR 2.51, 95%CI:1.12-5.6, p=0.03) conferred an OS benefit on risk-unadjusted analysis. On multivariable analysis, only neurosurgical resection was an independent predictor of OS (HR 0.16, 95%CI:0.04-0.59, p=0.006), controlling for age, BoD and RT. Systemic therapy and RT were not associated with OS. CONCLUSIONS: Resection of MCC BM may confer a survival benefit relative to non-operative management given appropriate patient selection. Prospective investigation of multimodal management of neurometastatic MCC is warranted, especially given the promise of new immunotherapy agents in treating MCC.

Research paper thumbnail of Choosing wisely after publication of level I evidence in breast cancer radiotherapy

Breast cancer (Dove Medical Press), 2018

Recent trials in early-stage breast cancer support hypofractionated whole-breast radiotherapy (WB... more Recent trials in early-stage breast cancer support hypofractionated whole-breast radiotherapy (WBRT) as part of breast-conserving therapy (BCT). Evidence also suggests that radiotherapy (RT) omission may be reasonable for some patients over 70 years. Among radiation-delivery techniques, intensity-modulated RT (IMRT) is more expensive than 3-dimensional conformal RT (3DCRT). Based on this evidence, in 2013, the American Society for Radiation Oncology (ASTRO) recommended hypofractionated schedules for women aged ≥50 years with early-stage breast cancer and avoiding routine use of IMRT for WBRT. To assess response to level I evidence and adherence to ASTRO recommendations, we evaluated the pattern of RT use for early-stage breast cancer at our National Comprehensive Cancer Network institution from 2006 to 2008 and 2011 to 2013 and compared the results with national trends. Data from a prospective database were extracted to include patients treated with BCT, aged ≥50 years, with histolo...

Research paper thumbnail of Patient-reported distress and survival among patients receiving definitive radiation therapy

Advances in radiation oncology

Patient-reported distress (PRD) has not been well assessed in association with survival after rad... more Patient-reported distress (PRD) has not been well assessed in association with survival after radiation therapy (RT). The aims of this study were to evaluate the association between PRD level and survival after definitive RT and to identify the main causes of distress in definitive RT patients. A total of 678 consecutive patients receiving definitive RT at our institution from April 2012 through May 2015 were included. All patients answered a PRD questionnaire that contained 30 items related to possible causes of distress, which could be rated from 1 (no distress) to 5 (high distress). Additionally, patients were asked to rate their overall distress level from 0 (no distress) to 10 (extreme distress). This overall distress level was our primary patient-reported distress measure and was examined as a continuous variable and as a categorical variable with 3 PRD levels (low, 0-3 [n = 295]; moderate, 4-6 [n = 222]; and high, 7-10 [n = 161]). As a continuous variable in multivariable Cox...

Research paper thumbnail of Outcomes and Patterns of Failure for Sinonasal Undifferentiated Carcinoma (SNUC): The Mayo Clinic Experience

International Journal of Radiation Oncology*Biology*Physics, 2016

comparison of FAK expression in central cells of recurrent and nonrecurrent cases of ameloblastom... more comparison of FAK expression in central cells of recurrent and nonrecurrent cases of ameloblastoma (PZ.3692) was found to be insignificant. Conclusion: FAK expression in odontogenic epithelium of ameloblastoma suggests its role in the locally aggressive behavior. FAK could be responsible for cell invasion and migration in ameloblastoma.

Research paper thumbnail of The Effect of Message Framing on African American Women’s Intention to Participate in Health-Related Research

Journal of Health Communication, 2016

This study examined the effect of message framing on African American women's intention to partic... more This study examined the effect of message framing on African American women's intention to participate in health-related research and actual registration in ResearchMatch (RM), a diseaseneutral, national volunteer research registry. A community-engaged approach was used involving collaboration between an academic medical center and a volunteer service organization formed by professional women of color. A self-administered survey which contained an embedded message framing manipulation was distributed to over 2,000 African American women attending the 2012 National Assembly of The Links, Incorporated. A total of 391 surveys were completed (187 containing the gain-framed message and 194 containing the loss-framed message). The majority (57%) of women expressed favorable intentions to participate in health-related research, and 21% subsequently enrolled in RM. The effect of message framing on intention was moderated by selfefficacy; there was no effect of message framing on RM registration, however those with high selfefficacy were over two times as likely as those with low self-efficacy to register as a potential study volunteer in RM (OR=2.62; 1.29,5.33). This investigation makes theoretical and practical

Research paper thumbnail of Outcomes of patients with loco-regionally recurrent or new primary squamous cell carcinomas of the head and neck treated with curative intent reirradiation at Mayo Clinic

Radiation oncology (London, England), Jan 9, 2016

We reviewed outcomes of patients with loco-regionally recurrent (LRR) or new primary (NP) squamou... more We reviewed outcomes of patients with loco-regionally recurrent (LRR) or new primary (NP) squamous cell carcinoma of the head and neck (SCCHN) treated at our institution with reirradiation (RRT). Patients received definitive RRT (DRRT) or post-operative RRT following salvage surgery (PRRT) from 2003 to 2011. Measured survival outcomes included loco-regional relapse free survival (LRFS) and overall survival (OS). Among 81 patients (PRRT, 42; DRRT, 39), median PRRT and DRRT doses were 60 Gy (12-70 Gy) and 69.6 Gy (48-76.8 Gy). The majority of patients received IMRT-based RRT (n = 77, 95 %). With median follow-up of 78.1 months (95 % CI, 56-96.8 months), 2-year OS was 53 % with PRRT and 48 % with DRRT (p = 0.12); 23 % of patients were alive at last follow-up. LRFS at 2 years was 60 %, and did not differ significantly between PRRT and DRRT groups. A trend toward inferior LRFS was noted among patients receiving chemotherapy with RRT versus RRT alone (p = 0.06). Late serious toxicities we...

Research paper thumbnail of Prevalent Health Concerns Among African American Women Belonging to a National Volunteer Service Organization (The Links, Incorporated)

Journal of Racial and Ethnic Health Disparities, 2015

Objective-African American women bear a disproportionate burden of cardiovascular disease (CVD) a... more Objective-African American women bear a disproportionate burden of cardiovascular disease (CVD) and cancer. The purpose of this study was to identify prevalent health concerns among African American women who are members of The Links, Incorporated (Links), a large national service organization with health programming for communities of color. Methods-Survey data (n=391) were collected during the 2012 Links National Assembly. Twenty-six health issues were presented within five groups: cancer, CVD, pulmonary disease, chronic conditions, and behavioral health. For each issue, women indicated if it was a concern for "you/your family" or "the African American community" via check-boxes. Differences in the proportions for "you/your family" and "the African American community" were evaluated using the McNemar test.

Research paper thumbnail of Radiotherapy concurrent with trastuzumab is well tolerated in the adjuvant treatment of women with HER2-positive breast cancer: cardiac safety data from the NCCTG N9831 study

European Journal of Cancer Supplements, 2006

Research paper thumbnail of Black Men’s Perceptions and Knowledge of Diabetes: a Church-Affiliated Barbershop Focus Group Study

Journal of Racial and Ethnic Health Disparities, 2015

Background Diabetes is the seventh leading cause of death in the USA and disproportionately affec... more Background Diabetes is the seventh leading cause of death in the USA and disproportionately affects racial and ethnic minorities. These disparities persist despite educational efforts to reduce the prevalence of diabetes. Receptiveness of educational efforts for Black men needs to be studied. Objective This study assesses Black men's receptiveness to a barbershop-based program focused on diabetes prevention and awareness in a church-affiliated barbershop in Rochester, Minnesota. Methods The pastor and barber of a church-affiliated barbershop and academic medical researchers designed a community-engaged research study to determine Black men's perception of diabetes. Recruitment for the 90-minute focus group included flyers (n=60), email, and in-person. Units of analysis included focus group audio recording, transcripts, and field notes. Using traditional content analysis, we categorized data into themes and subthemes. Results Thirteen Black men participated (group 1, n=6; group 2, n=7) having a mean age of 40.3 years (range 19 to 65), and employed full-time (77 %). Themes included diabetes prevention, treatment, prevalence, risks, and health education. Participants identified diet and exercise as essential components of diabetes prevention. Additionally, participants mentioned J

Research paper thumbnail of Angiosarcoma of the Scalp and Face

JAMA Otolaryngology–Head & Neck Surgery, 2015

and optimal treatment are unknown for angiosarcoma, an aggressive malignant tumor that affects va... more and optimal treatment are unknown for angiosarcoma, an aggressive malignant tumor that affects vascular endothelial cells and can be mistaken for benign lesions such as hemangioma. OBJECTIVE To determine the treatment outcomes of patients with angiosarcoma of the face or scalp treated with a combination of surgery, radiation therapy, and/or chemotherapy. DESIGN, SETTING, AND PARTICIPANTS Retrospective study of 55 patients with angiosarcoma of the face or scalp treated between January 1, 1973, and December 31, 2012, at a tertiary-care academic medical institution. INTERVENTIONS Surgery, radiation therapy, and/or chemotherapy. MAIN OUTCOMES AND MEASURES Locoregional control (LRC), recurrence-free survival (RFS), and overall survival (OS). RESULTS Fifty-five patients had angiosarcoma localized to the face or scalp. Forty of these patients (73%) received a combination of surgery, radiation therapy, and/or chemotherapy. Eight patients (15%) were treated with surgery alone, 1 (2%) with radiation alone, 5 (9%) with chemotherapy alone, and 1 (2%) with observation alone. Median (range) follow-up for surviving patients was 25.2 (4.7-227.1) months. Five-year LRC, RFS, and OS (95% CI) were 18% (7%-32%), 16% (6%-31%), and 38% (21%-54%), respectively. Of 36 patients with failed treatment, 34 had failure in a local and/or regional site. On univariate analysis, the use of multimodality therapy (vs no multimodality therapy) was associated with higher 5-year LRC (95% CI) (20% [3%-37%] vs 11% [0%-29%]; P = .04), higher RFS (19% [2%-36%] vs 10% [0%-27%]; P = .02), and higher OS (46% [26%-66%] vs 16% [0%-43%]; P = .04). Age 70 years or older (vs <70 years) was associated with lower 5-year LRC (95% CI) (5% [0%-14%] vs 48% [23%-74%]; P = .02) and lower RFS (5% [0%-13%] vs 49% [24%-75%]; P = .04). Radiation therapy (vs no radiation therapy) was associated with higher 5-year LRC (95% CI) (20% [3%-36%] vs 12% [0%-32%]; P = .02) and higher RFS (19% [2%-35%] vs 12% [0%-31%]; P = .004). On multivariable analysis, age younger than 70 years (vs Ն70 years) was associated with improved 5-year LRC (95% CI) (48% [23%-74%] vs 5% [0%-14%]; P = .03) and RFS (49% [24%-75%] vs 49% [24%-75%]; P = .04). CONCLUSIONS AND RELEVANCE Multimodality therapy for angiosarcoma is associated with improved LRC, RFS, and OS. Younger patients with resectable disease undergoing multimodality therapy for angiosarcoma had the best clinical outcomes.

Research paper thumbnail of Assessment of patient-reported measures of bowel function before and after pelvic radiotherapy: an ancillary study of the North Central Cancer Treatment Group study N00CA

Supportive Care in Cancer, 2012

Purpose-The Bowel Function Questionnaire (BFQ) has been used in clinical trials to assess symptom... more Purpose-The Bowel Function Questionnaire (BFQ) has been used in clinical trials to assess symptoms during and after pelvic radiotherapy (RT). This study evaluated the importance of symptoms in the BFQ from a patient perspective. Methods-Patients reported presence or absence of symptoms and rated importance of symptoms at baseline, 4 weeks after completion of pelvic RT, and 12 and 24 months after RT. The BFQ measured overall quality of life (QOL) and symptoms of nocturnal bowel movements, incontinence, clustering, need for protective clothing, inability to differentiate stool from gas, liquid bowel movements, urgency, cramping, and bleeding. Bowel movement frequency also was recorded. A content validity questionnaire was used to rate symptoms as "not very important," "moderately unimportant," "neutral," "moderately important," or "very important." Results-Most of the 125 participating patients rated all symptoms as moderately or very important. Generally, patients gave similar ratings for symptom importance at all study points, and ratings were independent of whether the patient experienced the symptom. Measures of greatest importance (moderately or very important) at baseline were ability to control bowel movements (94%), not having to wear protective clothing (90%), and not having rectal bleeding (94%). With the exception of need for protective clothing, the presence of a symptom at 4 weeks was associated with significantly worse QOL (P<.01 for all). Conclusions-The BFQ has excellent content validity. Patients rated most symptoms as moderately or very important, indicating the BFQ is an appropriate tool for symptom assessment during and after pelvic RT.

Research paper thumbnail of Prognostic factors in Merkel cell carcinoma: Analysis of 240 cases

Journal of the American Academy of Dermatology, 2013

Background: Knowledge regarding behavior of and prognostic factors for Merkel cell carcinoma (MCC... more Background: Knowledge regarding behavior of and prognostic factors for Merkel cell carcinoma (MCC) is limited. Objective: We sought to further understand the characteristics, behavior, prognostic factors, and optimal treatment of MCC. Methods: A multicenter, retrospective, consecutive study of patients with known primary MCC was completed. Overall survival and survival free of locoregional recurrence were calculated and statistical analysis of characteristics and outcomes was performed. Results: Among the 240 patients, the mean age at diagnosis was 70.1 years, 168 (70.0%) were male, and the majority was Caucasian. The most common location was head and neck (111, 46.3%). Immunosuppressed patients had significantly worse survival, with an overall 3-year survival of 43.4% compared with 68.1% in immunocompetent patients. In our study, patients with stage II disease had improved overall survival versus those with stage I disease, in a statistically significant manner. Patients with stage III disease had significantly worse survival compared with stage I and with stage II. Primary tumor size did not predict nodal involvement. Conclusion: The data presented represent one of the largest series of primary MCC in the literature and confirm that MCC of all sizes has metastatic potential, supporting sentinel lymph node biopsy for all primary MCC. Because of the unpredictable natural history of MCC, we recommend individualization of care based on the details of each patient's tumor and clinical presentation.

Research paper thumbnail of Phase III, Double-Blind Study of Depot Octreotide Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy: Results of North Central Cancer Treatment Group N00CA

Journal of Clinical Oncology, 2008

PurposeTo assess the effectiveness of depot octreotide for the prevention of diarrhea during pelv... more PurposeTo assess the effectiveness of depot octreotide for the prevention of diarrhea during pelvic radiation therapy.Patients and MethodsPatients receiving pelvic radiation therapy (planned minimum dose, 45 Gy; 1.7 to 2.1 Gy daily) were eligible for the study. From May 10, 2002, through October 14, 2005, 125 patients were randomly allocated in a double-blind fashion to receive octreotide (100 μg, administered subcutaneously on day 1, followed by depot octreotide, 20 mg, administered intramuscularly on days 2 and 29; n = 62) or to receive a placebo (n = 63).ResultsGrade 0, 1, 2, and 3 diarrhea were observed in 18%, 31%, 31%, and 21% of patients in the octreotide arm, respectively, and in 25%, 32%, 22%, and 21% of patients in the placebo arm, respectively (P = .64). Grade 0, 1, 2, and 3 abdominal cramps were observed in 32%, 45%, 21%, and 2% of patients receiving octreotide, respectively, and in 51%, 24%, 21%, and 5% of patients receiving the placebo, respectively (P = .053). Some pa...

Research paper thumbnail of Reply to N. Magne et al

Journal of Clinical Oncology, 2009

We thank Magne et al for their thoughtful comments. The issue of cardiac toxicity from trastuzuma... more We thank Magne et al for their thoughtful comments. The issue of cardiac toxicity from trastuzumab used in combination with radiation therapy (RT) for breast cancer remains an important one as women continue to be treated with both of these modalities. We emphasized in our work the need for longer follow-up in these patients treated with both trastuzumab and RT to determine whether our findings of lack of increased cardiac toxicity remain true over a greater length of time. Often cardiac manifestations of RT may not manifest until a decade or more after therapy. We performed two analyses to date evaluating cardiac toxicity acutely up to 14 months after commencement of RT, including the current analysis with a median follow-up of 3.7 years. Future analysis of is planned in the future given the known possibility of late occurrences of cardiac toxicity from RT in breast cancer treatment. Long-term monitoring of ejection fraction and of clinical events for at least 10 additional years from study entry is planned. We agree that great attention must be given to RT planning parameters relative to all critical normal structures that pose a risk for adverse events. In our trial, RT treatment planning details were not collected. Therefore, we are unable to comment on the cardiac volume irradiated in these patients. When our study was developed more than a decade ago, some RT techniques for internal mammary irradiation were known to be associated with greater coincident irradiation of the heart and with cardiac mortality. We were in uncharted territory at that time, so our approach was to prohibit irradiation of the internal mammary nodes in order to minimize the volume of heart irradiated as a safety precaution. More recently, some studies do suggest that patients treated in the older RT era experienced excess cardiac morbidity compared with those treated with more modern techniques where the irradiated cardiac volume is reduced. The use of more modern radiation treatment planning techniques, including three-dimensional computed tomography– based tools, has aided in cardiac sparing in breast cancer therapy. However, additional assessment of these more modern RT techniques, including those used in combination with newer systemic chemotherapeutic agents, is needed to assess the incidence of long-term development of cardiac issues. Despite the lack of longer-term information, we maintain that our recent study provides some assurance that the concurrent administration of RT and trastuzumab is associated with a safety profile that supports its use in contemporary practice. It is imperative that long-term analysis is conducted, and we, indeed, value the need for additional follow-up.