Anne F. Klassen

Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q.

Background: Measuring patient-reported outcomes has become increasingly important in cosmetic and reconstructive breast surgery. The objective of this study was to develop a new patient-reported outcome measure to assess the unique outcomes of breast surgery patients. Methods: Patient interviews, focus groups, expert panels, and a literature review were used to develop a conceptual framework and a list of questionnaire items. Three procedure-specific questionnaires (augmentation, reduction, and reconstruction) were developed and cognitive debriefing interviews used to pilot each questionnaire. Revised questionnaires were field tested with 1950 women at five centers in the United States and Canada (response rate, 72 percent); 491 patients also completed a test-retest questionnaire. Rasch measurement methods were used to construct scales, and traditional psychometric analyses, following currently recommended procedures and criteria, were performed to allow for comparison with existing measures. Results: The conceptual framework included six domains: satisfaction with breasts, overall outcome, and process of care, and psychosocial, physical, and sexual well-being. Independent scales were constructed for these domains. This new patient-reported outcome measure “system” (the BREAST-Q) contains three modules (augmentation, reconstruction, and reduction), each with a preoperative and postoperative version. Each scale fulfilled Rasch and traditional psychometric criteria (including person separation index 0.76 to 0.95; Cronbach’s alpha 0.81 to 0.96; and test-retest reproducibility 0.73 to 0.96). Conclusions: The BREAST-Q can be used to study the impact and effectiveness of breast surgery from the patient’s perspective. By quantifying satisfaction and important aspects of health-related quality of life, the BREAST-Q has the potential to support advocacy, quality metrics, and an evidence-based approach to surgical practice.

Measuring quality of life in cosmetic and reconstructive breast surgery: a systematic review of patient-reported outcomes instruments.

Background: Patient-reported outcomes in cosmetic and reconstructive breast surgery are increasingly important for clinical research endeavors. Traditional surgical outcomes, centered on morbidity and mortality, remain important but are no longer sufficient on their own. Quality of life has become a crucial research topic augmenting traditional concerns focused on complications and survival. Given this, reliable and valid patient questionnaires are essential for aesthetic and reconstructive breast surgeons. Methods: The authors performed a systematic literature review to identify patient-reported outcome measures developed and validated for use in cosmetic and reconstructive breast surgery patients. Qualifying instruments were assessed for adherence to international guidelines for health outcomes instrument development and validation. Results: The authors identified 227 health outcomes questionnaires used in breast surgery studies. After 135 generic instruments, 65 ad hoc instruments, seven oncologic instruments, 11 education questionnaires, and two non-English-language questionnaires were excluded, seven measures remained. Detailed analysis revealed that six of the seven measures had undergone limited development and validation. Only one measure, the Breast-Related Symptoms Questionnaire, demonstrated adequate development and validation in its target population. It had, nevertheless, significant content limitations. Conclusions: Valid, reliable, and responsive instruments to measure patient-reported outcomes in cosmetic and reconstructive breast surgery are lacking. To demonstrate the benefits of aesthetic and reconstructive breast surgery, future research to rigorously develop and validate new cosmetic and reconstructive breast surgery-specific instruments is needed.

Impact of Caring for a Child With Cancer on Parents’ Health-Related Quality of Life

PURPOSE To compare the health-related quality of life (QOL) of parents of children who are undergoing treatment for cancer with that of Canadian population norms and to identify important parent and child predictors of parental QOL. PATIENTS AND METHODS A total of 411 respondents of 513 eligible parents were recruited from five pediatric oncology centers in Canada between November 2004 and February 2007. Parents were asked to complete a questionnaire booklet that included a measure of adult QOL (SF-36), a measure of child health status (functional status IIR), and questions to assess health-promoting self-care actions (eg, sleep, diet, and exercise habits) and characteristics of the child with cancer (eg, relapse status, time since diagnosis, prognosis, treatment intensity). RESULTS Compared with population norms, parents of children with cancer reported poorer physical and psychosocial QOL in all psychosocial domains (effect sizes range, -0.71 to -1.58) and in most physical health domains (effect sizes range, -0.08 to -0.63). Parent characteristics associated with better parental QOL included better eating, exercise and sleep habits, younger age, and higher income. Child characteristics associated with better parental QOL included better child health status (functional status IIR scores), lower treatment intensity, and longer time since diagnosis. CONCLUSION Parents of children with cancer report poorer QOL compared with population norms. Interventions directed at parents should be included as part of the treatment plan for a child with cancer. Modifiable variables associated with poorer parental QOL, such as sleep quality and diet and exercise habits, indicate those parents most likely to experience poor QOL and may be potential areas for intervention.

Measuring Quality of Life in Oncologic Breast Surgery: A Systematic Review of Patient‐Reported Outcome Measures

Abstract:  Multiple randomized trials demonstrate equivalent survival between BCT and mastectomy, but clinical outcomes research must also evaluate patient satisfaction and quality of life. This review analyzes existing patient‐reported outcome (PRO) measures in oncologic breast surgery to assess utility and make recommendations for future research. We performed a systematic literature review to identify PRO measures used in oncologic breast surgery patients. After applying inclusion and exclusion criteria, qualifying instruments were assessed for adherence to international guidelines for health outcomes instrument development and validation. Ten measures underwent development and psychometric evaluation in an oncologic breast surgery population. Five of ten measures (EORTC QLQ BR‐23, FACT‐B, HBIS, BIBCQ, and BREAST‐Q) reported an adequate development and validation process. Three of these 5 measures (EORTC QLQ BR‐23, FACT‐B, HBIS) focused on non‐surgical treatment issues. A fourth instrument (BIBCQ) did not address aesthetic concerns after breast reconstruction. The fifth instrument (BREAST‐Q) was developed for use in patients undergoing mastectomy ± reconstruction, but did not address breast‐conserving therapy. Overall, two key limitations were noted: 1) surgery‐specific issues of breast‐conserving surgery patients were not well represented and 2) measures were largely developed without the aid of newer psychometric methods that may improve their clinical utility. Reliable and valid PRO measures in breast cancer patients exist, but even the best instruments do not address all important surgery‐specific and psychometric issues of oncologic breast surgery patients. Newer psychometric methods would facilitate development of scales for use in individual patient care as well as group level comparisons.

Measuring Quality of Life in Dysphonic Patients: A Systematic Review of Content Development in Patient-Reported Outcomes Measures

To review existing patient reported outcomes measures (PROMs) used in dysphonic populations to assess the procedures used in their development and the extent to which these meet current development standards for content generation and psychometric evaluation. The study is a systematic review. A systematic review of Medline, Cumulative Index to Nursing & Allied Health, and Health and Psychosocial Instruments databases was completed using voice, quality of life, and PROMs as keywords. We identified all patient or parent-reported questionnaires measuring quality of life associated with voice disorders from the review findings. Questionnaires were appraised for adherence to international guidelines for the development and evaluation of PROMs as outlined by the Scientific Advisory Committee of the Medical Outcome Trust. Nine PROMs fulfilled the inclusion criteria. The quality of these questionnaires was variable with regard to instrument development and none met all of the current, recommended criteria. Of the nine questionnaires, the Voice Symptom Scale underwent the most rigorous development process. Furthermore, many instruments have been augmented to allow for proxy administration, failing to address quality of life-related issues specific to the target population. Instrument development is often overlooked when attempting to quantify patient reported outcomes in dysphonic patients. Careful instrument development procedures are required to ensure that PROMs are valid, reliable, and responsive. Our review suggests that the deficits in psychometric properties of the current voice-related PROMs may be, at least in part, due to deficits in the development process. Furthermore, these data suggest the potential utility of a novel PROM adhering to rigorous international standards to better ensure that clinicians appreciate the variables most relevant to patients with voice disorders and address some of the psychometric shortcomings of the currently used questionnaires.

The health and psychosocial functioning of caregivers of children with neurodevelopmental disorders

Purpose. Children with neurodevelopmental disorders (Neuro) pose complex parenting challenges, particularly if the condition co-occurs with behaviour problems. Such challenges are likely to impact caregiver health and well-being. This study explores the extent to which caregivers of children with both Neuro and behaviour problems differ in their physical and psychosocial outcomes from caregivers of children with either condition or neither condition. Method. The first wave of data collected in the National Longitudinal Survey of Children and Youth in Canada (1994) was used to identify four groups of caregivers of 4-to 11-year-old children: caregivers of children with a Neuro disorder and externalising behaviour problems (Both; n = 414), caregivers of children with a Neuro disorder only (Neuro Only; n = 750), caregivers of children with an externalising behaviour problem only (Ext Only; n = 1067), and caregivers of children with neither health condition (Neither; n = 7236). Results. Caregivers in the Both group were least likely to report excellent or very good health, and more frequently reported chronic conditions such as asthma, arthritis, back problems, migraine headaches, and limitations in activities as compared to the Neither group. This group also exhibited higher depression scores, experienced more problematic family functioning and reported lower social support than the Neither group. Scores for caregivers in the Ext Only and Neuro Only groups tended to lie between the Both and Neither group scores and often did not differ from one another. Conclusions. Caregivers of children with both neurovelopmental disorders and behaviour problems exhibited a greater number of health and psychosocial problems. While addressing childrens behaviour problems, health care professionals should also consider caregiver physical and psychosocial health, as this may also have an impact on childrens well-being.

Patient satisfaction with postmastectomy breast reconstruction: a comparison of saline and silicone implants.

At a time when the safety and effectiveness of breast implants remains under close scrutiny, it is important to provide reliable and valid evidence regarding patient outcomes. In the setting of postmastectomy reconstruction, patient satisfaction and quality of life may be the most significant outcome variables when evaluating surgical success. The objective of the current study was to identify predictors of patient satisfaction with breast appearance, including implant type, in a large sample of women who underwent breast reconstruction surgery using implants.

Quality of life among breast cancer patients with lymphedema: a systematic review of patient-reported outcome instruments and outcomes.

PurposeLymphedema following breast cancer surgery remains a common and feared treatment complication. Accurate information on health-related quality of life (HRQOL) outcomes among patients with lymphedema is critically needed to inform shared medical decision making and evidence-based practice in oncologic breast surgery. Our systematic review aimed to (1) identify studies describing HRQOL outcomes in breast cancer-related lymphedema (BCRL) patients, (2) assess the quality of these studies, and (3) assess the quality and appropriateness of the patient-reported outcome (PRO) instruments used.MethodsUsing the PRISMA statement, we performed a systematic review including studies describing HRQOL outcomes among BCRL patients. Studies were classified by levels of evidence and fulfillment of the Efficace criteria. PRO instruments were assessed using the COSMIN criteria.ResultsThirty-nine studies met inclusion criteria, including 8 level I and 14 level II studies. Sixteen of 39 studies were compliant with the Efficace criteria. Seventeen HRQOL instruments were used, two specific to lymphedema patients. Exercise and complex decongestive therapy treatment interventions were associated with improved HRQOL.ConclusionsHigh-quality data on HRQOL outcomes is required to inform surgical decisions for breast cancer management and survivors. Of the lymphedema-specific PRO instruments, the Upper Limb Lymphedema 27 (ULL-27) was found to have strong psychometric properties. Future studies should strive to use high-quality condition- specific PRO instruments, follow existing guidelines for HRQOL measurement and to consider economic burdens of BCRL.Implications for Cancer SurvivorsAs lymphedema may develop many years after breast cancer surgery, the ULL-27 may offer greater content validity for use in survivorship research.

Satisfaction and quality of life in women who undergo breast surgery: A qualitative study

BackgroundIn cosmetic and reconstructive breast surgery, measurement of patient-reported outcomes has become increasingly important to research efforts and clinical care. We aimed to describe how breast conditions and breast surgery impact on patient satisfaction and quality of life.MethodsWe conducted qualitative, in-depth interviews with 48 women who had undergone either breast reduction (n = 15), breast augmentation (n = 12), or breast reconstruction (n = 21) surgery in order to begin to build a theoretical understanding of patient satisfaction and quality of life in breast surgery patients. Interviews were audio-taped, transcribed verbatim and analyzed thematically.ResultsThe patient interviews revealed that breast conditions and breast surgery impact women in the following six main areas: satisfaction with breasts; satisfaction with overall outcome; psychosocial well-being; sexual well-being; physical well-being; and satisfaction with the process of care. We used these six themes to form the basis of a conceptual framework of patient satisfaction and quality of life in women who undergo breast surgery.ConclusionOur conceptual framework establishes the main issues of concern for breast surgery patients. This new framework can be used to help develop local guidelines for future clinical assessment, management and measurement, establish the validity of the current management strategies, and develop evidence-based guidance for the development of new patient reported outcome measures for future outcomes research.

Identifying determinants of quality of life of children with cancer and childhood cancer survivors: a systematic review

PurposeThis paper describes a systematic review conducted to identify factors that have been investigated as explanations of variability in the quality of life of children with cancer and childhood cancer survivors. Our purpose was to build an evidence base that could be used to guide and direct future research.MethodsMEDLINE, CINAHL, EMBASE, PsycINFO, Cancerlit, and Sociological Abstracts were searched from the inception of each database to June 15, 2009 using the following search terms: “quality of life,” “health-related quality of life,” “quality adjusted life years,” “health status,” “functional status,” “well-being,” or “patient-reported outcome.” Sample characteristics and information about the relationship between a quality of life domain or total scale score and at least one factor (e.g., child gender or age, coping skills, family income) were extracted from eligible studies.ResultsNine cancer-specific and nine generic QOL questionnaires were used in 58 publications described 239 factors (50 unique factors). The large number of cancer, treatment, child, and family variables considered indicates that extensive research activity has occurred. However, most of the variables identified were examined in only a few studies and most represent medical and treatment variables with less research attention paid to child and family variables.ConclusionsOur study has compiled evidence about determinants of QOL for children with cancer and childhood cancer survivors from the existing literature. Future research can build on this evidence base to expand the range of factors studied as most research to date has focused on medical and treatment factors.