A Closer Look at the BREAST-Q ©




The BREAST-Q © is a multiscale, multimodule, patient-reported outcome instrument (PRO) measuring health-related quality of life and patient satisfaction in women who undergo breast surgery. This PRO instrument is the flagship of our team’s research, which has spanned almost a decade. This article provides detail about the BREAST-Q © . The BREAST-Q © represents a significant advance in measuring the impact and effectiveness of breast surgery from the patients’ perspective. In addition, our overall approach may provide a useful template for the development of future PRO instruments.


Key points








  • There is increasing demand for patient-reported outcome instruments in cosmetic and reconstructive breast surgery research and clinical practice.



  • The BREAST-Q © consists of procedure-specific modules (ie, Augmentation, Reduction/Mastopexy, Mastectomy, Reconstruction) with independent scales that examine the issues that are most important to women who have undergone each procedure.



  • The use of Rasch measurement methods to develop and test the scales of the BREAST-Q © means that there is a good understanding of the empirical item order across each scale, improving the ability to interpret the clinical meaning of scores as well as changes in scores.






Overview


In the past decade, our team has published extensively in the area of patient-reported outcome (PRO) research in plastic surgery. The BREAST-Q © is the flagship of our research to date. The motivation for developing the BREAST-Q © was that it is essential that surgeons play a central role in the development and application of PRO instruments, especially at a time when interpretation of such data is becoming vital to quality care. PRO instrument development and validation is complex, involving robust data collection from large, heterogeneous patient cohorts, analyzed using state-of-the art psychometric methods. This article revisits the BREAST-Q © and expands on what sets it apart from other breast surgery PRO instruments.




Overview


In the past decade, our team has published extensively in the area of patient-reported outcome (PRO) research in plastic surgery. The BREAST-Q © is the flagship of our research to date. The motivation for developing the BREAST-Q © was that it is essential that surgeons play a central role in the development and application of PRO instruments, especially at a time when interpretation of such data is becoming vital to quality care. PRO instrument development and validation is complex, involving robust data collection from large, heterogeneous patient cohorts, analyzed using state-of-the art psychometric methods. This article revisits the BREAST-Q © and expands on what sets it apart from other breast surgery PRO instruments.




Why was the BREAST-Q © developed?


There is increasing demand for high-quality, specially designed questionnaires, known as PRO instruments, in cosmetic and reconstructive breast surgery research and clinical practice. This demand is caused by the following factors:




  • Outcomes data such as complications and photographic analyses alone are no longer sufficient to support the progress being made in the field.



  • The public, health care payers, and policymakers have become increasingly attuned to the importance of health-related quality of life (HR-QOL) and the patient’s voice.



  • There is an emphasis on evidence-based practice coupled with a new focus on key indicators such as HR-QOL and patient satisfaction.



Despite the growing demand for PRO instruments, our systematic review found that none of the existing breast surgery–related measures captured a range of important outcomes in a scientifically sound manner. Therefore, we identified a need for a new PRO instrument to measure the perceptions of patients having reconstructive and cosmetic breast surgery. In developing this instrument for cosmetic and reconstructive breast surgery (named the BREAST-Q © ), we followed best practice guidelines. Our methods, described in more detail elsewhere, included in-depth patient and clinician interviews, literature review, focus groups, and cognitive debriefing. We also strove to develop explicit descriptions of each scale, to maximize their usefulness as clinically interpretable tools. As such, the new PRO instrument was developed bottom-up (from a construct definition), rather than top-down (from a method of grouping items) to ensure that substantive clinically grounded hypotheses determined scale content. This process involved several rounds of iterative qualitative enquiry using the methods described earlier to establish clinical validity. Our careful qualitative approach to content development is in keeping with the Rasch paradigm (described later), and provided an optimal foundation to fully understand the measurement performance of each new scale.




What is the BREAST-Q © ?


The BREAST-Q © is a PRO instrument designed to evaluate outcomes among women undergoing different types of breast surgery. There are currently 4 BREAST-Q © modules (ie, Augmentation, Reduction/Mastopexy, Mastectomy, Reconstruction), each of which comprises multiple scales. A fifth module (the BREAST-Q © : Breast Conserving Therapy module) is currently in development for women undergoing lumpectomy with and without radiation for the treatment of breast cancer.


The conceptual framework of the BREAST-Q © comprises the following 2 overarching themes (or domains): HR-QOL and patient satisfaction. Domain 1 (HR-QOL) comprises 3 subdomains: physical, psychosocial, and sexual well-being. Domain 2 (patient satisfaction) also comprises 3 subdomains: satisfaction with breasts, satisfaction with overall outcome, and satisfaction with care ( Fig. 1 ). Body image, a key issue for breast surgery patients, is considered across multiple subdomains (psychosocial and sexual well-being, satisfaction with breasts). The 4 modules have the same conceptual framework, with the exception of the Reconstruction module, which also includes the additional set of scales for measuring patient expectations.




Fig. 1


BREAST-Q © conceptual framework.

( From Pusic A, Klassen A, Scott A, et al. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q © . Plast Reconstr Surg 2009;124:345–53; with permission.)


For each subtheme, 1 (or more) BREAST-Q © scale was developed to examine specific aspects of HR-QOL and patient satisfaction. For example, the Satisfaction with Care subdomain includes 4 separate scales that measure satisfaction with the following: information, the plastic surgeon, the medical team, and the office staff. Across the modules and patient treatment groups, the scales are psychometrically linked and can thus be used for comparison between different patient groups. Box 1 shows the BREAST-Q © Reconstruction module as an example of the available scales.



Box 1


HR-QOL domains




  • 1.

    Psychosocial well-being. This scale measures psychosocial well-being with items that ask about body image (eg, accepting of body; attractive) and a woman’s confidence in social settings. Other items cover emotional health and self-esteem.


  • 2.

    Sexual well-being. This scale measures sexual well-being and body-image issues with items that ask about feelings of sexual attractiveness when clothed and unclothed and sexual confidence as it relates to the woman’s breasts, as well as how comfortable or at ease a woman feels during sexual activity.


  • 3.

    Physical well-being.



    • a.

      Chest and upper body. This scale measures physical problems such as pain (eg, neck, back, shoulder, arm, rib) and problems in the breast area (eg, tightness, pulling, tenderness, pain). Other items ask about activity limitations and sleep problems caused by discomfort.


    • b.

      Abdomen and trunk. This scale measures negative physical sequelae of the abdomen following autologous tissue reconstruction (TRAM or DIEP flap). Items cover abdominal discomfort, bloating, bulging, and pain as well as difficulty doing certain activities because of abdominal weakness.




Patient satisfaction domains




  • 1.

    Satisfaction with breasts. This scale measures body image in terms of a woman’s satisfaction with her breasts and asks questions regarding how comfortably bras fit, and how satisfied a woman is with her breast area both clothed and unclothed. Postoperative items ask about breast appearance (eg, size, symmetry, softness) and clothing issues (eg, how bras fit; being able to wear fitted clothes). There are also implant-specific items (eg, amount of rippling that can be seen or felt).


  • 2.

    Satisfaction with nipples. This scale measures satisfaction with the appearance of the reconstructed nipple and areola complex. Items cover shape, color, projection, and how natural the reconstructed nipple looks.


  • 3.

    Satisfaction with abdomen. This scale measures patient satisfaction with abdominal appearance following autologous tissue breast reconstruction (TRAM or DIEP flap). Items ask about overall appearance as well as position of navel (belly button) and scars.


  • 4.

    Satisfaction with outcome. This scale measures a woman’s overall appraisal of the outcome of her breast surgery. Items cover whether the woman’s expectations were met with respect to the aesthetic outcome and the impact surgery has had on her life, as well as satisfaction with the decision to have surgery (eg, whether the woman would do it again).


  • 5.

    Satisfaction with care



    • a.

      Information. This scale measures satisfaction with information provided about breast reconstruction surgery from the surgeon. Items cover types of breast reconstruction, complications and risks, healing and recovery time, how the breast(s) would look, implications for future breast cancer screening, how the surgery would be done, and breast appearance (eg, breast size, scars).


    • b.

      Surgeon. This scale measures satisfaction with the surgeon. Items ask about the surgeon’s manner (eg, professional, reassuring, thorough, sensitive) and communication skills (eg, easy to talk to). Items also cover the extent to which the patient was involved in the decision making and understood the process.


    • c.

      Medical team. This scale measures satisfaction with members of the medical team (other than the surgeon). Items ask whether the staff were professional, knowledgeable, and friendly, as well as how comfortable the woman was made to feel and whether she thought she was treated in a respectful manner.


    • d.

      Office staff. This scale measures satisfaction with interactions with members of the office staff. Items ask whether staff were professional, knowledgeable, and friendly, as well as how comfortable the woman was made to feel and whether she thought she was treated in a respectful manner.




Patient expectations domains


These scales are designed to be administered preoperatively and assess patient expectations for the process and outcome of surgery. The expectations scales compliment the satisfaction and health-related quality of life domains of the Postoperative Reconstruction module. Multi-item and categorical scale structures are used.



  • 1.

    Expectations for Support from Medical Staff. This scale measures how much time and emotional support the patient is expecting from the medical team and surgeon.


  • 2.

    Expectations for Pain. This scale measures the magnitude of pain the patient is expecting to experience in the first week after reconstruction surgery.


  • 3.

    Expectations for Coping. This scale measures how a patient is anticipating that she will cope with the process of breast reconstruction during the first year after surgery.


  • 4.

    Expectations for Breast Appearance and Outcome. This scale measures how a patient expects her breasts to look 1 year after surgery.


  • 5.

    Expectations for Psychosocial Well-being. This scale measures how a patient expects to feel about herself 1 year after breast reconstruction.


  • 6.

    Expectations for Sexual Well-being. This scale measures how a patient expects she will feel sexually 1 year after breast reconstruction.



Abbreviations : DIEP, Deep Inferior Epigastric Perforator; TRAM, Transverse Rectus Abdominis Myocutaneous.


BREAST-Q © Reconstruction module


Each BREAST-Q © scale is composed of a series of items (or questions) that evaluate a unidimensional construct. The items that form each scale reflect a clinically relevant hierarchy. As an example, in the Reconstruction module Satisfaction with Breasts scale, items span a range from “How satisfied are you with how you look in the mirror clothed?” to “How satisfied are you with how you look in the mirror unclothed?”


Each module of the BREAST-Q © has both preoperative and postoperative versions. The postoperative version includes all the preoperative items in addition to items that address unique postoperative issues (eg, scars). The preoperative and postoperative scales are linked psychometrically to measure change. Women may complete the preoperative questionnaire at any time before surgery (baseline assessment) and the postoperative questionnaire at any time point after surgery (follow-up data). The BREAST-Q © may also be administered at a single time point as in a cross-sectional survey. BREAST-Q © users may decide the time points to administer the scales. The BREAST-Q © Reconstruction module Patient Expectations scales differ in that they are designed for preoperative administration only.


Patients do not need to complete all BREAST-Q © scales in any given study or clinical encounter. Each scale is designed to function independently. Patients can thus be asked to complete some or all of a module’s BREAST-Q © scales. A researcher or clinician may therefore select a subset of scales depending on the purpose of the particular study or use. As an example, in a quality improvement program, the 4 scales evaluating satisfaction with care might be used (Satisfaction with Information, Satisfaction with Surgeon, Satisfaction with Medical Team, Satisfaction with Office Staff), or the Satisfaction with Breast scale might be used alone in a study to evaluate a new breast surgery technique.




How is the BREAST-Q © scored?


For new PRO instruments to be appropriately used and widely accepted in different clinical scenarios, clinicians require well-targeted, reliable, and valid instruments that can also be easily scored. To achieve this requires both a psychometrically robust PRO instrument and a method of automatically scoring its data, based on items that are appropriately calibrated within a specifically defined, clinically meaningful, frame of reference. Scoring methods for PRO instruments have received little attention in the health arena. Our team developed a stand-alone executable software application called Q-Score to allow data entry, automatic scoring, and export. The scores are generated based on scoring algorithms housed in the RUMM 2030 software program.


Patient responses to items in each scale are transformed through the Q-Score scoring software ( Fig. 2 ). Each scale has a unique scoring algorithm. The software provides the ability to read patient scale response data into the program, score the set of responses to each scale attempted, and write the complete set of transformed scores for all scales attempted to an electronic file. Once the set of responses are accepted, the program immediately scores these data and estimates a Rasch-based person measure, ranging from 0 to 100. This measure is based on the calibration of each set of items in each scale. All item response data, scoring, and measures can then be exported into a text file for further analyses.


Nov 20, 2017 | Posted by in General Surgery | Comments Off on A Closer Look at the BREAST-Q ©

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