Purpose
Lymphedema 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.
Methods
Using 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.
Results
Thirty-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.
Conclusions
High-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 Survivors
As lymphedema may develop many years after breast cancer surgery, the ULL-27 may offer greater content validity for use in survivorship research.
The goal of postmastectomy breast reconstruction is to restore a woman’s body image and to satisfy her personal expectations regarding the results of surgery. Studies in other surgical areas have shown that unrecognized or unfulfilled expectations may predict dissatisfaction more strongly than even the technical success of the surgery. Patient expectations play an especially critical role in elective procedures, such as cancer reconstruction, where the patient’s primary motivation is improved health-related quality of life. In breast reconstruction, assessment of patient expectations is therefore vital to optimal patient care. This report summarizes the existing literature on patient expectations regarding breast reconstruction, and provides a viewpoint on how this field can evolve. Specifically, we consider how systematic measurement and management of patient expectations may improve patient education, shared medical decision-making and patient perception of outcomes.
Background
The main objectives of this study were to identify the number of randomized controlled trials (RCTs) that have included a patient-reported outcome (PRO) endpoint across a wide range of cancer specialties and to evaluate completeness of PRO reporting according to the CONSORT PRO extension.
Methods
RCTs with a PRO endpoint, conducted across several cancer specialties and published between 2004 and 2013 were considered. Studies were evaluated based on previously defined criteria, including the CONSORT PRO extension and the Cochrane Collaboration's tool for assessing RCT Risk of Bias. Analyses were also conducted by type of PRO endpoint (primary versus secondary) and by cancer disease site.
Results
A total of 56,696 potentially eligible records were scrutinized and 557 RCTs with a PRO evaluation, enrolling overall 254,677 patients, were identified. PROs were most frequently used in RCTs of breast (N=123), lung (N=85) and colorectal (N=66) cancer. Overall, PROs were secondary endpoint in 421 (76%) RCTs. Four out of six CONSORT PRO items evaluated were documented in less than 50% of the RCTs. Level of reporting was higher in RCTs with PRO as a primary endpoint. Presence of a supplementary report was the only statistically significant factor associated with greater completeness of reporting for both RCTs with PRO as primary (β=0.19; P=0.001) or secondary endpoint (β=0.30; P<0.001).
Conclusion
Implementation of the CONSORT PRO extension is equally important across all cancer specialties. Its use can also contribute in revealing the robust PRO design of some studies, which might be obscured by poor outcome reporting.
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