Sally E. Jensen

Measuring Health-Related Quality of Life in Leukemia: The Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) Questionnaire

OBJECTIVE Develop and validate a health-related quality-of-life (measure for patients with acute and chronic leukemia. METHODS The study consisted of two phases: scale construction and scale validation. For the item-generation phase, a summary of the literature combined with qualitative results from item-generation interviews with 29 acute or chronic leukemia patients and 16 health care providers yielded an initial item pool reflecting leukemia-specific concerns and symptoms. Items underwent iterations of review and reduction according to defined retention criteria to support content validity, as defined by priority concerns of patients. Seventeen final leukemia-specific items were combined with the Functional Assessment of Cancer Therapy-General to create the FACT-Leukemia (FACT-Leu) scale. For the validation phase, 79 individuals with acute or chronic leukemia completed questionnaires at three time points. RESULTS All FACT-Leu subscale and aggregated scores showed high internal consistency (αs ranging from 0.75 to 0.96). Test-retest reliability was adequate for all subscales (intraclass correlation range 0.765-0.890). The FACT-Leu scale demonstrated good convergent validity, with significant correlations with quality-of-life criteria and performance status, in the expected direction. FACT-Leu subscale scores were significantly different among the three performance status change groups, suggesting good responsiveness to change. CONCLUSIONS The FACT-Leu scale is a valid, reliable, and efficient measure of leukemia-specific health-related quality of life for acute and chronic disease.

Quality of Life Considerations in Upper Limb Transplantation: Review and Future Directions

PURPOSE As reconstructive transplantation emerges as an increasingly viable option for upper limb amputees, a better understanding of quality of life (QOL) outcomes is needed to evaluate the benefits and risks of the procedure from the patient perspective. METHODS To address this need, we searched PubMed (1998-2011) to characterize QOL outcomes among upper limb transplant recipients. We identified 27 articles reporting on QOL outcomes in hand transplantation. Common instruments to assess domains of QOL in hand transplantation include the Disabilities of the Arm, Shoulder, and Hand questionnaire, the Medical Outcomes Study Short Form-36, and the International Registry on Hand and Composite Tissue Transplantations Hand Transplantation Score System. RESULTS Preliminary reports using standardized measures indicate that most hand transplant recipients described improved QOL. Several studies also qualitatively reported that recipients expressed satisfaction with cosmetic, sensory, functional, and social outcomes after transplantation. However, our review suggests that the measurement of QOL in hand transplantation is limited, although it is largely driven by QOL considerations. CONCLUSIONS This review highlights the need for improved measurement of QOL in hand transplantation. The preliminary QOL findings across published hand transplantation articles will aid in improving the future assessment of QOL in hand transplantation. TYPE OF STUDY/LEVEL OF EVIDENCE Therapeutic III.

Opportunities for shared decision making in kidney transplantation

Health researchers and policy‐makers increasingly urge both patient and clinician engagement in shared decision making (SDM) to promote patient‐centered care. Although SDM has been examined in numerous clinical settings, it has received little attention in solid organ transplantation. This paper describes the application of SDM to the kidney transplantation context. Several distinctive features of kidney transplantation present challenges to SDM including fragmented patient–provider relationships, the time‐sensitive and unpredictable nature of deceased organ offers, decision‐making processes by transplant providers serving as both organ guardians (given the

A new index of priority symptoms in advanced ovarian cancer.

OBJECTIVE This study sought to develop and examine preliminary validity of the NCCN-FACT Ovarian Symptom Index-18 (NFOSI-18), a new ovarian cancer-specific symptom index comprised of symptoms rated as highest priority by both oncology clinical experts and women with advanced ovarian cancer. METHODS Fifty-one women with advanced ovarian cancer rated the importance of 30 symptoms associated with advanced ovarian cancer. Ten gynecologic oncologists then rated symptoms according to whether they were predominantly disease- or treatment-related. Patient priorities were then reconciled with previously-published clinician priorities for symptom measurement in ovarian cancer. This produced the NFOSI-18. Participants also completed measures of quality of life and performance status to examine preliminary validity of the NFOSI-18. RESULTS An 18-item symptom index for advanced ovarian cancer was developed, including three subscales: disease-related symptoms, treatment-related symptoms, and general function/well-being. Lower NFOSI-18 scores indicate greater high-priority symptom burden. Preliminary reliability suggests good internal consistency (α=0.80). The NFOSI-18 and its subscales were significantly positively associated with quality of life validity criteria. Scores on the NFOSI-18 differed significantly by performance status, with poor performance status associated with lower NFOSI-18 scores. CONCLUSIONS The NFOSI-18 shows preliminary evidence for reliability and validity as a brief assessment of the most important symptoms associated with treatment for advanced ovarian cancer.

Bone outcomes and technical measurement issues of bone health among children and adolescents: Considerations for nutrition and physical activity intervention trials

Weight-bearing physical activity and calcium intake are two important behavioral influences for bone health. Physical-activity and calcium-intake intervention trials with youth have been implemented to evaluate their efficacy and effectiveness to decrease the risk for subsequent osteoporosis and fractures. Technical aspects of bone measurement have not been routinely reported in published trials of youth, even though they can have an impact on study findings and interpretation. This paper provides an overview of the outcome variables reported, and technical issues—such as software and bone detection, growth, and movement—that affect bone mass measurements among children and adolescents. It describes the implications of these issues for the interpretation of intervention effects observed in intervention trials, and provides recommendations for future research.

Virally mediated cervical cancer in the iatrogenically immunocompromised: applications for psychoneuroimmunology.

Oncogenic or high-risk (HR) human papillomavirus (HPV) infection is implicated in the pathogenesis of a number of cancers, including cervical cancer. HPV infected individuals who are immunocompromised secondary to acquired (e.g., human immunodeficiency virus [HIV]) or iatrogenic (e.g., systemic lupus erythematosus [SLE] patients and organ and hematopoeitic stem cell transplant recipients undergoing immunosuppressive therapy) immune deficiency are particularly at risk for HPV-initiated cervical neoplasia and cancer. Psychoneuroimmunologic (PNI) research has demonstrated that psychosocial factors such as stress, pessimism, and sleep quality may play a role in the promotion of HPV-mediated cervical neoplasia in HIV-positive women. However, no research to our knowledge has examined PNI mechanisms of HPV-mediated cervical neoplasia and cancer in women who are undergoing iatrogenic immunosuppressive therapy for the treatment of autoimmune disease or the prevention of graft-rejection. This article reviews the PNI mechanisms that may underlie the promotion of HPV-mediated cervical neoplasia and applies this model to HPV-infected women who are iatrogenically immunosuppressed, an understudied population at-risk for cervical cancer. Female transplant recipients, one such group, may provide a unique paradigm in which to explore further PNI mechanisms of HPV-mediated cervical neoplasia.

The Challenge of Informed Consent for Increased Risk Living Donation and Transplantation

The Organ Procurement and Transplantation Network (OPTN) mandates that organ recipients provide “specific informed consent” before accepting organs that the OPTN defines as “increased risk”. However, the OPTN does not provide specific guidelines for what information should be disclosed to potential recipients. Such vagueness opens the door to inadequate informed consent. This paper examines the ethical dimensions of informed consent when the prospective living donor has self‐reported behaviors associated with increased risk for infection transmission. Donor privacy is a primary ethical concern that conflicts with recipients’ informed consent for use of increased risk organs. We propose that both the increased risk status and the specific behavior be disclosed to the recipient. Because the actual risk posed is linked to the type of risk behavior, disclosure is therefore needed to make an informed decision. The donors risk behavior is material to recipients’ decision making because it may impact the donor–recipient relationship. This relationship is the foundation of the donation and acceptance transaction, and thus comprises a critical feature of the recipients informed consent. Optimizing a recipients informed consent is essential to protecting patient safety and autonomy.

Using a qualitative approach to conceptualize concerns of patients with neurofibromatosis type 1 associated plexiform neurofibromas (pNF) across the lifespan.

Neurofibromatosis Type 1 (NF1) plexiform neurofibromas (pNFs) are associated with a variety of symptoms and concerns that affect patients’ quality of life (QOL), highlighting the value of incorporating the patients’ perspective when evaluating treatment outcomes. To better conceptualize the experience of patients with pNFs, this qualitative study sought to identify the most important outcomes to assess from the perspective of patients, families, and clinicians. Clinicians, patients age 5 years old and above, and parents of patients aged 5–17 years participated in semi‐structured interviews to elicit the pNF symptoms/concerns considered most important to assess. The data were analyzed using an iterative coding procedure and the frequency with which symptoms/concerns emerged was tabulated. Eight clinicians, 31 patients, and 17 parents of patients participated in semi‐structured interviews. The most frequently reported concerns raised by patients across all age groups included pain, appearance/disfigurement, social activity/role participation, stigma, and anxiety. For parents, physical functioning was the primary concern, followed by pain, social activity/role participation, appearance/disfigurement, and social relationships. The resulting conceptual framework included five domains to represent the most important identified symptoms/concerns: pain, social functioning, physical function impact, stigma, and emotional distress. This conceptual framework describing the symptoms/concerns of patients with pNF can help investigators create a measurement system to improve assessment of aspects of QOL only patients can report on. It may also provide the ability to identify symptoms/concerns that might warrant referrals to various clinical disciplines.

Development of a shared decision-making tool to assist patients and clinicians with decisions on oral anticoagulant treatment for atrial fibrillation

Abstract Objective: Decision aids (DAs) are increasingly used to operationalize shared decision-making (SDM) but their development is not often described. Decisions about oral anticoagulants (OACs) for atrial fibrillation (AF) involve a trade-off between lowering stroke risk and increasing OAC-associated bleeding risk, and consideration of how treatment affects lifestyle. The benefits and risks of OACs hinge upon a patient’s risk factors for stroke and bleeding and how they value these outcomes. We present the development of a DA about AF that estimates patients’ risks for stroke and bleeding and assesses their preferences for outcomes. Research design and methods: Based on a literature review and expert discussions, we identified stroke and major bleeding risk prediction models and embedded them into risk assessment modules. We identified the most important factors in choosing OAC treatment (warfarin used as the default reference OAC) through focus group discussions with AF patients who had used warfarin and clinician interviews. We then designed preference assessment and introductory modules accordingly. We integrated these modules into a prototype AF SDM tool and evaluated its usability through interviews. Results: Our tool included four modules: (1) introduction to AF and OAC treatment risks and benefits; (2) stroke risk assessment; (3) bleeding risk assessment; and (4) preference assessment. Interactive risk calculators estimated patient-specific stroke and bleeding risks; graphics were developed to communicate these risks. After cognitive interviews, the content was improved. The final AF tool calculates patient-specific risks and benefits of OAC treatment and couples these estimates with patient preferences to improve clinical decision-making. Conclusions: The AF SDM tool may help patients choose whether OAC treatment is best for them and represents a patient-centered, integrative approach to educate patients on the benefits and risks of OAC treatment. Future research is needed to evaluate this tool in a real-world setting. The development process presented can be applied to similar SDM tools.

Development of a Symptom Index for Patients with Primary Brain Tumors

OBJECTIVES This studys primary goals included identifying the highest priority symptoms of patients with advanced brain tumors on treatment, comparing patient priority ratings with those of oncology experts, and constructing a brief symptom index using combined input to assess these symptoms and concerns. METHODS Fifty patients with advanced primary brain tumors and 10 physician experts were recruited from the National Comprehensive Cancer Network institutions and community support agencies. By using a 40-item symptom checklist, patients first selected up to 10 of the most important symptoms/concerns to monitor when assessing the value of drug treatment for brain tumors, then nominated up to 5 of the very most important concerns, and finally generated additional symptoms/concerns. By using the same checklist as patients, physicians rated each symptom/concern as disease- or treatment-related. RESULTS By using the combined input, a 24-item National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Brain Symptom Index (NFBrSI-24) was developed. The NFBrSI-24 showed good internal consistency (α = 0.84), significantly differentiated patients with different levels of functional status (F2,47 = 8.21; P < .001), and demonstrated good convergent validity with the Functional Assessment of Cancer Therapy-General functional, physical, social, emotional, and brain tumor-specific concerns (ρ = 0.59, 0.57, 0.40, 0.35, and 0.50, respectively; Ps < 0.05). CONCLUSIONS The NFBrSI-24, an index of the symptoms in advanced brain tumors perceived as most important by both patients and clinicians, improves upon existing measures of brain tumor symptoms through better satisfaction of regulatory requirements for measure development. The findings suggest good reliability and validity, indicating that the NFBrSI-24 is a promising brief assessment of high-priority advanced brain tumor symptoms for research and clinical settings.