Patient-reported outcome measurements in post-mastectomy implant-based breast reconstruction and radiotherapy: Analysis of BREAST-Q data

Abstract

Background:

Breast reconstruction has become a standard of care in patients undergoing mastectomy, greatly improving their quality of life. An increasing number of patients-reported outcome measurements (PROMs) have been developed over the years to better analyze patients’ subjective overall experience. BREAST-Q is the PROMs for breast surgery introduced in our practice to assess patients’ experiences when undergoing implant-based breast reconstruction and radiotherapy along with the use of Peak Plasma Blade and acellular dermal matrix.

Methods:

The pre-operative version of the Reconstruction BREAST-Q was administered to all 88 patients enrolled between December 2017 and December 2018 in the Plastic Reconstructive Surgery Unit at Fondazione IRCCS Istituto Nazionale Tumori Milano through person-to-person interviews, while the post-operative version was administered to the 75 patients who completed a 12-month follow-up (four patients died during one-year follow-up and nine patients had major complications). The survey areas highlighted were: satisfaction with breast, psychosocial well-being, physical well-being and sexual well-being.

Results:

From BREAST-Q questions regarding Satisfaction With The Appearance Of The Breast and Psychosocial Well-Being outcomes showed significant improvement from pre-operative data, as well as with Satisfaction With Overall Care, with the exception of Physical Well-Being Chest.

Conclusions:

BREAST-Q allows the assessment of patients’ perception, not only for surgical results, but also for the overall experience with surgeons and medical staff.

The women enrolled in our study reported an overall good patient satisfaction in most of the analyzed fields.

Keywords

Implant-based breast reconstruction radiotherapy radiotherapy and breast reconstruction quality of life patient reported outcome measurements peak plasma blade acellular dermal matrix BREAST-Q

Introduction

Breast cancer and mastectomy can deeply affect body image and sexual function causing depression, anxiety, dissatisfaction, mood disturbances, and shame.¹

For these reasons, over the years, breast reconstruction has achieved a life-changing role in those patients undergoing mastectomy and the consequent improvement of health-related quality of life (HR-QOL) is unquestionably tangible.

Since data concerning morbidity, mortality and photographic analyses are no longer enough to support HR-QOL evaluation in patients undergoing breast surgery, the attention to patient-reported outcome measurements (PROMs) is constantly increasing.

PROMs are useful to better understand the impact of oncologic breast surgery from patients’ perceptive, reporting personal feelings and experiences in terms of body image, physical and psychological functioning.

Several PROMs have been developed over the years,^2–10 with the common denominator of addressing aspects of patients’ subjective experience with breast surgery, but not all of them have undergone formal development or psychometric evaluation.

In 2009 Pusic et al.¹¹ developed a reliable, valid and easily scored instrument named BREAST-Q, to evaluate outcomes in women undergoing cosmetic and reconstructive breast surgery, as well as patient satisfaction.

BREAST-Q boasts several modules (ie. Augmentation, Breast Cancer, Reduction/Mastopexy and the incoming Health Utility Module), composed of multiple scales, with both pre-operative and post-operative versions. The post-operative version includes all the pre-operative items in addition to the items that address unique post-operative issues. The preoperative and postoperative scales are linked psychometrically to measure changes.¹²

BREAST-Q’s conceptual model for breast cancer surgery analyzes psychological, sexual and physical well-being, as well as satisfaction with breast and overall outcome and care.

In December 2017 we started a prospective observational study focused on the use of PEAK PlasmaBlade (Medtronic, Minneapolis USA), a pulses radiofrequency electrosurgery, in implant-based breast reconstruction along with acellular dermal matrix (ADM) Veritas (Synovis Surgical Innovations, St. Paul, MN, USA), in women who had previously undergone radiotherapy. Results describing the reconstructive outcomes obtained with this surgical strategy have been recently reported, with encouraging evidence.¹³

Accordingly, we hypothesized that the combination of PEAK PlasmaBlade and ADM Veritas in post-mastectomy radiotherapy implant-based breast reconstruction could also result in a superior HR-QOL and better patient satisfaction. Here we reported the results of the patient satisfaction as measured through BREAST-Q.

Methods

Patients and study design

A prospective observational study focused on the use of PEAK PlasmaBlade in implant-based breast reconstruction along with ADM Veritas in women who had previously undergone radiotherapy was started in Plastic Reconstructive Surgery Unit at Fondazione IRCCS Istituto Nazionale Tumori Milano in December 2017. The clinical study protocol was approved by the Institutional Review Board and conducted in accordance with all accepted standards for human clinical research. All patients gave written informed consent before study enrollment. Details about the study protocol are reported in Sala et al.¹³ Briefly, the entire patient cohort consisted in women who underwent expander reconstruction after mastectomy, and received radiotherapy on the expander, as well as implant-based breast reconstruction patients who had capsular contracture (Spear-Baker grade III or IV)¹⁴ due to previous radiotherapy and were eligible for implant replacement. Among the overall population some patients received pre-operative fat grafting (from one to four treatments), some others did not, depending on the cutaneous and subcutaneous tissues quality.

The goal of the protocol was to prevent capsular contracture onset in the expander group and recurrence in the implant group, as well as lower the overall complications rate.

The pre-operative Italian version of the Reconstruction BREAST-Q was administered to all 88 patients enrolled between December 2017 and December 2018 through a person-to-person interview, before surgery.

The post-operative version of Reconstruction BREAST-Q was administered to 75 patients who completed the 12 months follow-up (four patients died during one-year follow-up and nine patients had major complications).

Satisfaction with breast, psychosocial well-being, physical well-being and sexual well-being were investigated through the questionnaire.

The results were analyzed using Q-score software which allowed automatic scoring so that raw data were automatically transformed into summary scores ranging from 0 to 100 (from very dissatisfied to very satisfied). Each scale has a unique scoring algorithm.

Statistical analysis

Standard descriptive statistics—medians and IQR for continuous variables and frequency tables for categorical variables—were used to describe the study sample and the pivotal variable distributions. Floor and ceiling effects were expressed, for each question, as the percentages of bottom and top scores of the scales, respectively. The nonparametric Wilcoxon signed-rank test (WSRT) was used to compare the pre- and post-reconstruction distributions of the summary scores. Finally, comparisons between the study cohort and the normative data²⁰ were performed in terms of means and corresponding 95% Confidence Intervals. All the analyses were performed with the SAS software (Version 9.4.; SAS Institute, Inc., Cary, NC, USA) by adopting a nominal alpha value of 5%.

Results

Demographic characteristics of the population are summarized in Table 1.

Table 1.

Descriptive statistics of the study cohort.

	N	%
Age, years, median (range)	56 (34-75)
BMI, kg/m², median (range)	24.08 (17.8-40.4)
Smoking status
Former smokers	16	21.33
Nonsmokers	45	60.00
Current smokers	14	18.67
Comorbidities
No	55	73.33
Yes	20	26.67
Concomitant contralateral symmetrization
No	22	30.14
Yes	51	69.86
Postoperative additional procedures (within 12 months follow-up)
No	69	93.24
Yes	5	6.76
Mastectomy
Nipple-sparing	17	22.67
Skin-reducing	1	1.33
Skin-sparing	3	4.00
Total	54	72.00
Axillary procedure
Lymph node biopsy	10	13.33
Axillary dissection	63	84
None	2	2.67
Type of reconstruction
Expander	35	46.67
Implant	40	53.33
Implant size, mL, median (range)	525 (180-775)
Suction drainage appliance, days, median (range)	20 (7-53)

The patients enrolled in the study had a median age of 56 years and a median BMI value of 24.08, meaning that they were normal weight. Of these patients, 60% were non-smokers and more than 73% had no comorbidities.

Seventy-two percent of women underwent a total mastectomy and 70% had a concomitant contralateral symmetrization but little less than 7% had an additional postoperative procedure within the 12 months of follow-up after the surgery. The median dimension of the implant was of 525 g and more than 97% of patients underwent axillary procedures.

BREAST-Q questionnaire

All patients completed the pre-operative Reconstruction BREAST-Q, whereas the post-operative form was completed only by 75 patients who attended 12-month follow-up (nine patients experienced major complications and four patients died during the study period).

Abdomen issues (questions number 4 and 5 in pre-operative and 7, 8 and 9 in the post-operative form) were not investigated, as well as questions regarding nipple reconstruction (question number 10 in the post-operative form) because autologous reconstruction was not the goal of the study and only few patients underwent nipple reconstruction within 12-month follow-up. Regarding the Reconstruction BREAST-Q scores, each domain was considered properly.

Pre and post-operative satisfaction

We observed higher post-reconstruction scores compared to the pre-operative ones (WSRT p-value <0.01) (Table 2). For the pre-operative score distributions only a few subject reported the maximum score values (ceiling effect) and the floor effect (i.e. proportion of subjects receiving the minimum possible score) was observed in 4% of women for the Sexual Well-Being score. By looking at the post-reconstruction scores, regarding the ceiling effect (i.e. proportion of subjects receiving the maximum possible score), the highest observed value was 70% for Psychosocial Well-Being, whereas the minimum was observed for the Satisfaction With Breasts (21%). By looking at the floor effect, the highest observed values were 4% for Physical Well-Being.

Table 2.

Descriptive statistics of pre- and post-operative satisfaction.

	time	n	missing	n at floor	n at ceiling	min	25th centile	median	75th centile	max	IQR*	WSRT** p-value
Psychosocial well-being^a	Pre-Operative	75	0	0	2	19	45	55	63	100	18	<0.01
Psychosocial well-being^a	Post-Operative	73	2	0	51	36	73	100	100	100	27	<0.01
Sexual well-being scale^b	Pre-Operative	68	7	3	1	0	37	43	54	100	17	<0.01
Sexual well-being scale^b	Post-Operative	63	12	1	34	0	52	100	100	100	48	<0.01
Physical well-being^c	Pre-Operative	75	0	0	5	28	50	63	71	100	21	<0.01
Physical well-being^c	Post-Operative	73	2	3	26	0	77	85	100	100	23	<0.01
Satisfaction with breasts^d	Pre-Operative	75	0	0	0	22	33	43	53	79	20	<0.01
Satisfaction with breasts^d	Post-Operative	73	2	0	15	39	62	71	91	100	29	<0.01

Consists of body image issues, such as acceptance and feeling of attractiveness as well as confidence in social settings, emotional health and self-esteem.

Measures sexual well-being and body-image issues concerning feelings of sexual attractiveness when clothed and unclothed and sexual confidence during sexual activity, considering the reconstructed breast.

Concerns chest and upper body is related to physical problems such as pain (i.e., neck, back, shoulder, arm, rib) and problems in the breast area (i.e., tightness, pulling, tenderness, pain), as well as activity limitations and sleep problems caused by discomfort.

Satisfaction with breasts that evaluates how comfortably bras fit, and how satisfied a woman is with her breast area with or without clothes, whereas post-operative items focus on breast characteristics such as size, symmetry, softness, rippling seen or felt as well as clothing aspects like bras fitting and the possibility of wearing fitted clothes).

Post-operative satisfaction

Regarding post-operative scores, we observed high skewed distributions (Table 3). Scores related to the surgical/medical quality (i.e. Satisfaction With Overall Care) showed high ceiling effect and no floor effects. In addition, the Satisfaction With Outcome and the Satisfaction With Overall Care (Breast Reconstruction Surgery) reached high percentage of ceilings (72% and 73%, respectively) and only one patient for Satisfaction With Outcome registered the minimum score (floor effect).

Table 3.

Descriptive Statistics of Post-Operative Satisfaction.

	n	missing	n at floor	n at ceiling	min	25th centile	median	75th centile	max	IQR
Satisfaction with outcome^a	72	3	1	52	0	80	100	100	100	20
Satisfaction with overall care (breast reconstruction surgery)^b	73	2	0	53	40	85	100	100	100	15
Satisfaction with overall care (surgeon skill)^c	73	2	0	62	39	100	100	100	100	0
Satisfaction with overall care (medical team)^d	73	2	0	63	36	100	100	100	100	0
Satisfaction with overall care (office staff)^e	73	2	0	68	36	100	100	100	100	0

This scale measures how satisfied a woman is in terms of outcomes and with respect to her expectations and it values weather a woman would undergo that kind of surgery or not.

Satisfaction with information provided by the surgeon about breast reconstruction surgery, subsequent breast appearance, healing and recovery time, complications and risks and possible implications for breast cancer screening.

Satisfaction with the surgeon in terms of professionalism, empathy, communication skills and capability, as well as patient’s involvement and understanding of surgical decisions.

Satisfaction with the other members of medical team in terms of information given, respect and interaction capability.

Satisfaction during interaction with the office staff.

Comparison with normative data

Data from a study including American women with and without breast cancer recruited from an online community among Army of Women members were here used as normative data.²⁰ By comparing the Reconstruction Module Normative Scores - obtained on 1201 women – with ours (Figure 1), we found higher Sexual Well-Being Score than the normative ones, with a mean score of 77 (95%CI: 70-84) compared to the 56 (95%CI: 55-57). On the contrary, Physical Well-Being Score was slightly lower than the normative value, with an average score of 82 (95%CI: 76-87) compared to 93 (95%CI: 92-94).

Figure 1.

Bar chart of observed and normative data. Each bar reports the mean value together with the 95%CI.

Discussion

Mastectomy could be a very upsetting event in woman life because it deeply impacts on self-esteem, sense of self and social relationships.

Even if the attention is firstly focused on the diagnosis, body image becomes crucial when oncological treatments are over and the desire to go back to normal life increases.¹⁵ This is the reason why breast reconstruction plays a detrimental role in the resulting HR-QOL.

Patient experience of care is an important element of patients’ global satisfaction. BREAST-Q scales are useful to assess satisfaction with information, surgeon, medical team, and office staff.

The perception of surgical outcomes is influenced by many factors including patients’ expectations and adequate preoperative information. Ho et al.¹⁶ demonstrated that if a patient is satisfied with the information given by the plastic surgeon and the relationship with the surgeon, she will be more likely to be satisfied with the assessment of her surgical outcome and HR-QOL.^17–19

Over the years in our practice we have also experienced what Ho et al.¹⁶ established in their paper, so we are used to doing our best for patients not only during surgery, but also in terms of pre- and post-operative communication. Our results confirmed this evidence, with more than 70% of patients reporting an extremely good relationship with both surgeon and the medical/office staff, both with the information received and how they were humanely assisted.

With regard to BREAST-Q item of Satisfaction With The Appearance Of The Breast and Psychosocial Well-Being, outcomes showed significant improvement from pre-operative data, supporting our encouraging results¹³ also from the HR-QOL point of view. These two items are easily related because if a woman has more self-confidence with her body, she will be more likely to feel more confident not only with herself, but also with other people and, moreover, during everyday social activities. During the person-to-person pre-operative interviews we found out that a lot of women avoid situations where their body can be seen as they are ashamed of their appearance and do not want people to feel sorry for them.

Therefore, we understand how important is to make women “feel normal” and we are honoured to be able to contribute to improving patients’ quality of life.

Interestingly, we observed higher scores for the main reconstructive modules with the exception of Physical Well-Being With The Chest. We expected different results or rather an amelioration of Physical Well-Being With The Chest, considering that patients suffered from pre-operative capsular contracture, so the resolution of this complication should have improved Physical Well-Being With The Chest. We performed capsulectomy in all patients and that should have helped in improving the sensation of pressure and hardness. Moreover, the use of acellular dermal matrix should had corroborated in developing soft new capsula.

We can speculate that this is due to patients’ higher expectations of improvement for Physical Well-Being With The Chest, without taking into account that radiotherapy affects chest-wall tissues for a life-time.

The negative effects of radiotherapy such as subcutaneous fibrosis, chest wall pain, tightening and thinning of tissues can be only slightly improved with surgery. For these reasons most of the patients had undergone fat grafting before our surgery.

Our study has some limitation, such as the relatively small sample size, the absence of a control group and a longer follow-up period needed.

To remedy the lack of a control group, we made a comparison with normative data (Figure 1).²⁰ We believe our scores are higher because of the population we studied and the expectations they had. Our group is composed of women undergoing implant-based breast reconstruction and radiotherapy, whereas the normative data belong to both women with and without cancer.

As previously mentioned, we hypothesized that the slightly lower score in Physical Well-Being With The Chest in our population can be related to radiotherapy sequelae.

This evidence is promising and supports a good satisfaction in all the reconstructive steps with PEAK PlasmaBlade and ADM Veritas in post-mastectomy implant-based breast reconstruction in the setting of radiotherapy.

Conclusion

Breast reconstruction has become a standard of care in patients undergoing mastectomy, as well as HR-QOL evaluation with PROMs.

The BREAST-Q is a functional and valid tool to assess the overall patients experience, satisfaction and relation with surgeon and office/medical staff. Women included in our study¹³ reported an overall good patient satisfaction in almost every field.

Footnotes

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Laura Sala

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