Enablers and barriers to accessing self-management support services for those living with and beyond cancer: A qualitative study using the theoretical domains framework.

BACKGROUND: Supporting those living with and beyond cancer to self-manage their health can optimise health-related quality of life and reduce symptom burden. Self-management support (SMS) programmes have been shown to be effective, but uptake is often low. This qualitative study aimed to identify experienced and perceived enablers and barriers to accessing SMS services among those who had completed primary cancer treatment and were living with and beyond cancer. METHODS: Participants were recruited through social media and cancer advocacy groups. Semi-structured telephone and online interviews were conducted. Transcripts were coded inductively based on participants' reported experiences. Statements related to factors that enable or inhibit access to SMS were then mapped to the Theoretical Domains Framework (TDF). RESULTS: Twenty-six people participated. Six themes explain the factors that act as barriers and enablers which mapped to 11 TDF domains. Lack of knowledge of available SMS was a prominent barrier, as well as inaccessible services due to timing and place of delivery. Lack of confidence and emotional factors including fear were barriers to seeking SMS. Social influences shaped knowledge, attitudes and readiness to access SMS. Perceptions of SMS service goals and if in alignment with self-identity, intentions and goals also shaped decisions around accessing support. CONCLUSIONS: While lack of knowledge and provider signposting were common barriers, findings suggest that other psychosocial and emotional factors may be barriers, even if SMS services are accessible. Findings are relevant for oncology healthcare services developing strategies to increase reach of SMS for those living with and beyond cancer.

Determinants of regulatory compliance in health and social care services: A systematic review using the Consolidated Framework for Implementation Research.

BACKGROUND: The delivery of high quality care is a fundamental goal for health systems worldwide. One policy tool to ensure quality is the regulation of services by an independent public authority. This systematic review seeks to identify determinants of compliance with such regulation in health and social care services. METHODS: Searches were carried out on five electronic databases and grey literature sources. Quantitative, qualitative and mixed methods studies were eligible for inclusion. Titles and abstracts were screened by two reviewers independently. Determinants were identified from the included studies, extracted and allocated to constructs in the Consolidated Framework for Implementation Research (CFIR). The quality of included studies was appraised by two reviewers independently. The results were synthesised in a narrative review using the constructs of the CFIR as grouping themes. RESULTS: The search yielded 7,500 articles for screening, of which 157 were included. Most studies were quantitative designs in nursing home settings and were conducted in the United States. Determinants were largely structural in nature and allocated most frequently to the inner and outer setting domains of the CFIR. The following structural characteristics and compliance were found to be positively associated: smaller facilities (measured by bed capacity); higher nurse-staffing levels; and lower staff turnover. A facility's geographic location and compliance was also associated. It was difficult to make findings in respect of process determinants as qualitative studies were sparse, limiting investigation of the processes underlying regulatory compliance. CONCLUSION: The literature in this field has focused to date on structural attributes of compliant providers, perhaps because these are easier to measure, and has neglected more complex processes around the implementation of regulatory standards. A number of gaps, particularly in terms of qualitative work, are evident in the literature and further research in this area is needed to provide a clearer picture.

Patient-reported outcome measures evaluating postpartum maternal health and well-being: a systematic review and evaluation of measurement properties.

OBJECTIVE: This study aimed to systematically review and evaluate postpartum health and well-being using patient-reported outcome measures across all domains of postpartum health using the COnsensus-based Standards for the selection of health Measurement INstruments guidelines. DATA SOURCES: Based on a preprepared published protocol, a systematic search of PubMed, Embase, and CINAHL was undertaken to identify patient-reported outcome tools. The protocol was registered with the International Prospective Register of Systematic Reviews (registration number CRD42021283472), and this work followed the COnsensus-based Standards for the selection of health Measurement INstruments guidelines for systematic reviews. STUDY ELIGIBILITY CRITERIA: Studies eligible for inclusion included those that assessed a patient-reported outcome measure examining postpartum women's health and well-being with no limitation on the domain. The included studies aimed to evaluate one or more measurement properties of the patient-reported outcome measure. METHODS: Data extraction and the methodological assessment of the quality of the patient-reported outcome measure were assessed by 2 reviewers independently based on content validity, structural validity, internal consistency, cross-cultural validity or measurement invariance, reliability, measurement error, hypotheses testing for construct validity, and responsiveness, as defined by the COnsensus-based Standards for the selection of health Measurement INstruments. The standard used for content validity were the domains of importance to women in postpartum health and well-being proposed by the International Consortium for Health Outcomes Measurement. The outcome domains for patient-reported health status include mental health, health-related quality of life, incontinence, pain with intercourse, breastfeeding, and motherhood role transition. The quality of the methods was rated an overall rating of results, awarded a level of evidence, and assessed using the Grading of Recommendations, Assessment, Development, and Evaluations assessment tool, and a level of recommendation was awarded for each tool. RESULTS: There were 10,324 studies identified in the initial search, of which 29 tools were identified from 41 eligible studies included in the review. Moreover, 21 tools were awarded an "A" grading of recommendation for use as a patient-reported outcome measure in postpartum women following the COnsensus-based Standards for the selection of health Measurement Instruments standards. Of the "A"-rated tools, 17 (80%) examined the domain of mental health, 5 examined health-related quality of life, 4 examined breastfeeding, and 6 represented role transition. No "A"-recommended tool examined postpartum incontinence or pain with intercourse. Of note, 3 tools did not cover domains as recommended by the International Consortium for Health Outcomes Measurement, and 5 tools were awarded a "B" rating, requiring more research before their recommendation for use. Here, most tools were awarded very low-moderate Recommendations, Assessment, Development, and Evaluations level of evidence. Moreover, the highest quality tool identified that covered multiple domains of postpartum health and well-being was the women's Postpartum Quality-of-Life Questionnaire. CONCLUSION: This systematic review identified the best performing patient-reported outcome measures to assess postpartum health and well-being. No individual tool covers all 6 domains of postpartum health and well-being. Here, the highest quality tool found that covered multiple domains of postpartum health and well-being was the Postpartum Quality-of-Life Questionnaire. The Postpartum Quality-of-Life Questionnaire captures 4 of 6 domains of importance to women, with domains of incontinence and sexual health unevaluated. The domain of urinary incontinence was represented by the International Consultation on Incontinence Questionnaire Short Form, which requires further psychometric analysis before its recommended use. Postpartum sexual health, not represented by any tool, necessitates the development of a patient-reported outcome measure. A postpartum patient-reported outcome measure would be best provided by a combination of tools; however, further research is required before its implementation.

Determinants of regulatory compliance in health and social care services: a systematic review protocol.

Background: The delivery of high quality health and social care services is a fundamental goal for health systems worldwide. The measurement of quality in health and social care services is a complex task as there are a myriad of determinants and outcome measures to choose from. Researchers in this field have assessed a range of organisational and environmental factors (for example: staff composition, facility ownership, facility size) for an association with various measurements for quality. Compliance with regulations is one such quality measure. Compliance with regulations is variable and the determinants of this variability are under-investigated. Identifying the determinants of compliance has the potential to improve regulatory processes and can inform quality improvement initiatives undertaken by service providers and policy makers. This protocol describes a systematic review which will review literature from a wide range of study designs and sources to develop an overview of the determinants of regulatory compliance in health and social care services. Methods: A wide range of study designs and grey literature will be sought for this review. Searches will be conducted using PubMed, MEDLINE, PsycInfo, SocINDEX and CINAHL databases. The studies included in the review will be subject to quality appraisal with reference to the collection of tools available from the Joanna Briggs Institute. Data extraction will be informed by the Consolidated Framework for Implementation Research (CFIR). A narrative synthesis will be conducted with reference to the CFIR and Normalisation Process Theory (NPT). GRADE-CERQual will be used to grade the overall body of evidence. Conclusion: The findings of this review will be useful to regulators to inform regulatory policy and practice. Service providers and policy makers may also use the findings to inform quality improvement initiatives aimed at improving compliance and quality across a range of health and social care services.

Patients' satisfaction with the reconstructive options provided to them measured 18 months after mastectomy surgery for breast cancer.

INTRODUCTION: Mastectomy patients' satisfaction with reconstructive options has not been examined. METHODS: A national study measured 18-month satisfaction with reconstructive options and collected case-mix and reconstructive offer and uptake data on breast cancer patients having mastectomy with or without immediate reconstruction (IR) in England between January 2008 and March 2009. Multivariable logistic regression examined the relationship between satisfaction, age, IR offer and uptake, and clinical suitability. RESULTS: Of 4796 patients, 1889 were not offered IR, 1489 declined an offer and 1418 underwent it. Women not offered IR were more likely older, obese or smokers and had higher ASA grades, ECOG scores, tumour burdens and adjuvant chemotherapy and radiotherapy likelihoods (9% of lowest suitability group offered IR; 81% in highest suitability group). 83.7% were satisfied with their reconstructive options, varying significantly by IR offer and uptake (76.1% for those not offered IR; 85.8% for those who declined IR; 91.7% following IR). Older women and women deemed more suitable for IR were more often satisfied (p-values <0.001). CONCLUSIONS: Satisfaction varied by offer and uptake status, age and suitability score. Clinicians should target equity for women deemed unsuitable by exploring their needs and desired outcomes, standardising operative fitness assessments and utilising shared decision-making aids.

The drivers and impact of emergency care reconfiguration in Ireland: Results from a large mixed-methods research programme.

Ireland, like many countries, has reconfigured emergency care in recent years towards a more centralised model. Although centralisation is presented as 'evidence-based', the relevance of this evidence is challenged by groups which hold values beyond those implicit in the literature. The Study of the Impact of Reconfiguration on Emergency and Urgent Care Networks (SIREN) programme was funded to evaluate the development and performance of emergency and urgent care systems in Ireland. SIREN found that the drivers of reconfiguration in Ireland are based on safety and efficiency claims which are highly contestable. Reconfiguration was not associated with improvements in safety or efficiency and may have exacerbated the growing capacity challenges for acute hospitals. These findings are consistent with UK research. Our study adds to an emerging literature on the interaction between a narrow technocratic approach to health system planning and the perspectives of the public and patients.

Educational intervention to optimise serum immunoglobulin test use in Irish primary care: an interrupted time series with segmented regression analysis.

BACKGROUND: Implementation science experts recommend that theory-based strategies, developed in collaboration with healthcare professionals, have greater chance of success. AIM: This study evaluated the impact of a theory-based strategy for optimising the use of serum immunoglobulin testing in primary care. DESIGN AND SETTING: An interrupted time series with segmented regression analysis in the Cork-Kerry region, Ireland. An intervention was devised comprising a guideline and educational messages-based strategy targeting previously identified GP concerns relevant to testing for serum immunoglobulins. METHOD: Interrupted time series with segmented regression analysis was conducted to evaluate the intervention, using routine laboratory data from January 2012 to October 2016. Data were organised into fortnightly segments (96 time points pre-intervention and 26 post-intervention) and analysed using incidence rate ratios with their corresponding 95% confidence intervals. RESULTS: In the most parsimonious model, the change in trend before and after the introduction of the intervention was statistically significant. In the 1-year period following the implementation of the strategy, test orders were falling at a rate of 0.42% per fortnight (P<0.001), with an absolute reduction of 0.59% per fortnight, corresponding to a reduction of 14.5% over the 12-month study period. CONCLUSION: The authors' tailored guideline combined with educational messages reduced serum immunoglobulin test ordering in primary care over a 1-year period. Given the rarity of the conditions for which the test is utilised and the fact that the researchers had only population-level data, further investigation is required to examine the clinical implications of this change in test-ordering patterns.

Efficacy of observational hand hygiene audit with targeted feedback on doctors' hand hygiene compliance: A retrospective time series analysis.

BACKGROUND: Healthcare-associated infection compromises patient safety. Compliance with hand hygiene (HH) guidelines has been shown to be an effective method of reducing infection; however, it remains suboptimal and poorer among doctors compared to other healthcare workers. The aim of this study is to determine the relationship between an individualised observational hand hygiene audit (OHHA) and feedback intervention with observed HH compliance. METHODS: We used a retrospective interrupted time series design using OHHA data from a five-year period, 2011-2015. OHHA indicated poorer HH compliance among doctors than other healthcare workers in a 345-bed acute private hospital. An increase in orthopaedic surgical site infection prompted additional auditing of the orthopaedic unit further identifying substandard HH compliance among orthopaedic surgeons. In addition to ongoing HH interventions, an individualised hand hygiene audit and feedback intervention focusing on consultant orthopaedic surgeons was implemented. Observed HH compliance improved. The intervention was then extended to include all consultant doctors at the study site. Audit was implemented by trained clinical nurse managers during clinical rounds. Written audit feedback was provided by the infection prevention and control team. RESULTS: HH compliance increased significantly among both orthopaedic surgeons and other consultant doctors, P < 0.05. CONCLUSION: An individualised audit and feedback intervention was effective in improving compliance. Incorporation of OHHA with individualised feedback into routine daily practice needs to be considered as a quality improvement opportunity. This study has the potential to inform other audit and feedback interventions to maximise effectiveness and ensure implementation.

Educational Interventions to Enhance Situation Awareness: A Systematic Review and Meta-Analysis.

STATEMENT: We conducted a systematic review to evaluate the comparative effectiveness of educational interventions on health care professionals' situation awareness (SA). We searched MEDLINE, CINAHL, HW Wilson, ERIC, Scopus, EMBASE, PsycINFO, psycARTICLES, Psychology and Behavioural Science Collection and the Cochrane library. Articles that reported a targeted SA intervention or a broader intervention incorporating SA, and an objective outcome measure of SA were included. Thirty-nine articles were eligible for inclusion, of these 4 reported targeted SA interventions. Simulation-based education (SBE) was the most prevalent educational modality (31 articles). Meta-analysis of trial designs (19 articles) yielded a pooled moderate effect size of 0.61 (95% confidence interval = 0.17 to 1.06, P = 0.007, I = 42%) in favor of SBE as compared with other modalities and a nonsignificant moderate effect in favor of additional nontechnical skills training (effect size = 0.54, 95% confidence interval = 0.18 to 1.26, P = 0.14, I = 63%). Though constrained by the number of articles eligible for inclusion, our results suggest that in comparison with other modalities, SBE yields better SA outcomes.

A Rasch Measurement Theory Approach to Improve the Interpretation of Patient-reported Outcomes.

INTRODUCTION: Interpretability is a key challenge for researchers, clinicians, and patients interested in using the output of patient-reported outcome (PRO) instruments. When rich and detailed meaning is required to assist individual patients to make treatment choices we propose that the item content of psychometric rating scales should be better leveraged to improve interpretability. METHODS: Modern psychometric methods such as Rasch measurement theory allow PRO users to map patient progress up or down a scale over time to item benchmarks. These benchmarks represent the relative difficulty associated with each item contained in a scale. The most difficult items benchmark the best overall outcome on a scale and the least difficult items represent the worst overall outcome. The group-level effects of different treatment options can also be mapped to item benchmarks and compared with those of individual patients. DISCUSSION: The proposed method leverages the content already available in PRO instruments to improve interpretation. This approach locates both individuals (in this instance breast cancer patients undergoing surgery) and treatments (in this instance breast reconstruction techniques), on a hierarchy of health variables where each variable represents a progressively more advanced step in the recovery process. The approach can specify the aspects of a health concept where patients are currently competent, and the aspects which they might gain from a new treatment. It can also assist attempts by industry to communicate specific treatment benefits to their target audience. KEY POINTS: The method is best applied when patients need guidance about the likely benefits of different treatment options, when a PRO instrument has been developed using a modern psychometric method such as Rasch measurement theory, when there is good evidence from well-conducted studies of the group-level benefits of different treatment options, and these benefits have been measured using appropriate PROs. The method depends on good "fit" of individual patient responses to an underlying model. However, even when fit is poor it may be useful for patients to understand the "ladder" of health achievements for their condition (from the perspective of the average patient) and where different treatment options sit on this ladder.

The influence of observational hand hygiene auditing on consultant doctors' hand hygiene behaviors: A qualitative study.

BACKGROUND: Compliance with hand hygiene guidelines reduces the risk of health care-associated infection, yet doctors are less compliant than other health care workers. Use of observational hand hygiene auditing with targeted individualized feedback was implemented, with improved hand hygiene of consultant doctors; however, the factors that influenced this were not explained by previous quantitative data. The aim was to explore consultant doctors' opinions about the influence of observational hand hygiene auditing with individualized feedback on hand hygiene behavior. METHODS: Using the Theoretical Domains Framework, we conducted 12 semi-structured in-depth interviews with consultant doctors who experienced the observational hand hygiene audit and feedback intervention. Data were analyzed using a thematic analysis approach. RESULTS: Analysis identified 8 domains of the Theoretical Domains Framework, with 5 dominant domains: (1) behavioral regulation: receiving written individualized audit feedback positively influenced practice; (2) knowledge: provision of specific individualized feedback improved performance; (3) reinforcement: audit highlighted substandard practices; (4) social professional role and identity: audit reports triggered profession-associated competitive motivation; and (5) environmental context and resources: auditing was perceived to be synonymous with strong organizational safety culture. CONCLUSIONS: In this study, provision of individualized targeted feedback was a critical component of observational hand hygiene auditing.

General practitioners' knowledge, attitudes, and experiences of managing behavioural and psychological symptoms of dementia: A mixed-methods systematic review.

OBJECTIVES: To synthesise the existing published literature on general practitioners (GP)'s knowledge, attitudes, and experiences of managing behavioural and psychological symptoms of dementia (BPSD) with a view to informing future interventions. METHODS: We conducted a systematic review and synthesis of quantitative and qualitative studies that explored GPs' experiences of managing BPSD (PROSPERO protocol registration CRD42017054916). Seven electronic databases were searched from inception to October 2017. Each stage of the review process involved at least 2 authors working independently. The meta-ethnographic approach was used to synthesise the findings of the included studies while preserving the context of the primary data. The Confidence in the Evidence from Reviews of Qualitative research (CERQual) was used to assess the confidence in our individual review findings. RESULTS: Of the 1638 articles identified, 76 full texts were reviewed and 11 were included. Three main concepts specific to GPs' experiences of managing BPSD emerged: unmet primary care resource needs, justification of antipsychotic prescribing, and the pivotal role of families. A "line of argument" was drawn, which described how in the context of resource limitations a therapeutic void was created. This resulted in GPs being over reliant on antipsychotics and family caregivers. These factors appeared to culminate in a reactive response to BPSD whereby behaviours and symptoms could escalate until a crisis point was reached. CONCLUSION: This systematic review offers new insights into GPs' perspectives on the management of BPSD and will help to inform the design and development of interventions to support GPs managing BPSD.

General practitioners' knowledge, attitudes and experiences of managing behavioural and psychological symptoms of dementia: protocol of a mixed methods systematic review and meta-ethnography.

BACKGROUND: In the context of rising dementia prevalence, the workload of general practitioners (GPs) in dementia care is set to increase. However, there are many aspects of dementia care that GPs find challenging. Behavioural and psychological symptoms of dementia (BPSD) affect the majority of people with dementia and is an aspect of dementia care that GPs find particularly difficult to manage. The aim of this mixed methods systematic review is to undertake a synthesis of qualitative and quantitative studies on GPs' knowledge, attitudes and experiences of managing BPSD. METHODS: Seven electronic bibliographic databases will be searched from inception to present. All qualitative or quantitative studies that explore the knowledge, attitude or experiences of GPs towards the management of BPSD in community and/or residential settings will be eligible for inclusion. A meta-ethnography will be conducted to synthesise included studies. Primary outcome measures will include GPs' experiences of managing BPSD, GPs' knowledge of BPSD and their attitude to different approaches to the management of BPSD, in particular their attitude to non-pharmacological approaches. All included papers will be independently assessed for methodological validity by two reviewers using the following tools: the Joanna Briggs Institute checklist for qualitative research, the Effective Public Health Practice Project (EPHPP) tool for intervention studies and the National Institute of Health (NIH) quality assessment tool for observational and analytical cross-sectional studies. As there is no agreed quality assessment tool for descriptive cross-sectional studies, an original tool will be developed. Two independent reviewers will apply the Confidence in the Evidence from Reviews of Qualitative Research (CERQual) tool to the review findings. The results will be reported in line with the Enhancing Transparency in Reporting the Synthesis of Qualitative Research (ENTREQ) statement. DISCUSSION: This study will be the first systematic review that synthesises the existing literature of GPs' knowledge, attitudes and experiences of managing BPSD in community and residential care. This review will improve our understanding of GPs' perspectives on the management of BPSD, and the results will be used to inform the development of an intervention to improve the management of BPSD in general practice. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017054916 .

Measuring the patient perspective on latissimus dorsi donor site outcomes following breast reconstruction.

BACKGROUND: There is little evidence about the long-term donor site outcome of latissimus dorsi breast reconstruction and no patient-reported outcome measures designed specifically for the procedure. METHODS: A prospective cohort of breast cancer patients having latissimus dorsi reconstruction after a mastectomy was recruited from 270 hospitals in the United Kingdom. An 18-month follow up questionnaire containing two novel scales was sent to consenting patients. The prevalence of aesthetic and functional morbidity at the donor site was described. The two new scales were refined using the Rasch measurement model and subsequently validated. RESULTS: 1,096 women completed the new scales. 78% of patients reported that no back appearance issues had bothered them "most of the time" or "all of the time" in the past two weeks. The equivalent figure for functional morbidity was 60%. Four items were eliminated following initial psychometric testing. This produced an 8-item Back Appearance scale and an 11-item Back and Shoulder Function scale. Both scales showed adequate fit to the Rasch measurement model. Higher levels of aesthetic and functional bother were observed for completely autologous procedures versus those where latissimus dorsi reconstruction was used to cover an implant (p <0.05). Higher levels of aesthetic bother were observed in women who had suffered a perioperative complication at the donor site (p = 0.003). CONCLUSION: These results can inform patients of the morbidity associated with latissimus dorsi reconstruction. The new scales can be used to compare groups undergoing different variations of the procedure and to monitor individual patients.

Physician and practice characteristics associated with immunoglobulin test ordering.

Background: Primary care test requests for serum immunoglobulins are rising rapidly, with concerns that many requests may be unnecessary. Evidence suggests some characteristics of general practitioners (GPs) and practices are associated with higher test ordering. Objective: To identify the physician and practice characteristics associated with immunoglobulin test ordering. Methods: Retrospective, cross-sectional study using routine laboratory data on primary care serum immunoglobulin requests. Data were linked with GP patient list size data. The primary outcome measure was the count of test requests per GP. Predictor variables were physician gender, years experience, practice region and type (number of GPs), GP patient list size and composition. Mixed-effects multilevel regression models were used to calculate incidence rate ratios (IRRs) with 95% confidence intervals (CIs) for the associations between physician and practice characteristics and GP requesting. Sensitivity analysis was performed by limiting the model to the more than 70 years age category. Results: In total, 5990 immunoglobulin tests were ordered by 481 GPs in the South of Ireland during 2013. The number of tests ordered by individual GPs varied from one to 377. In the final fully adjusted Poisson regression analysis, female gender (IRR: 1.81; 95% CI: 1.45-2.26) and less experience (IRR: 2.27; 95% CI: 1.47-3.51) were associated with higher requesting (P < 0.001). None of the practice factors were associated with test ordering. Sensitivity analysis on the 70 years or more age category found similar results. Conclusion: Further research is required to explore the potential reasons for higher requesting among GPs with fewer years of experience and also among female GPs.

'Working away in that Grey Area ' A qualitative exploration of the challenges general practitioners experience when managing behavioural and psychological symptoms of dementia.

Background: general practitioners (GPs) have identified the management of behavioural and psychological symptoms of dementia (BPSD) as a particularly challenging aspect of dementia care. However, there is a paucity of research on why GPs find BPSD challenging and how this influences the care they offer to their patients with dementia. Objectives: to establish the challenges GPs experience when managing BPSD; to explore how these challenges influence GPs' management decisions; and to identify strategies for overcoming these challenges. Design: qualitative study of GPs experiences of managing BPSD. Methods: semi-structured interviews were conducted with 16 GPs in the Republic of Ireland. GPs were purposively recruited to include participants with differing levels of experience caring for people with BPSD in nursing homes and in community settings to provide maximum diversity of views. Interviews were analysed thematically. Results: three main challenges of managing BPSD were identified; lack of clinical guidance, stretched resources and difficulties managing expectations. The lack of relevant clinical guidance available affected GPs' confidence when managing BPSD. In the absence of appropriate resources GPs felt reliant upon sedative medications. GPs believed their advocacy role was further compromised by the difficulties they experienced managing expectations of family caregivers and nursing home staff. Conclusions: this study helps to explain the apparent discrepancy between best practice recommendations in BPSD and real-life practice. It will be used to inform the design of an intervention to support the management of BPSD in general practice.

The association between complications and quality of life after mastectomy and breast reconstruction for breast cancer.

BACKGROUND: Medical treatment for breast cancer is associated with substantial toxicity and patient burden. There is less known about the impact of surgical complications. Understanding this impact could provide important information for patients when they are considering surgical options. METHODS: Between 2008 and 2009, the UK National Mastectomy and Breast Reconstruction Audit recorded surgical complications for a prospective cohort of 17,844 women treated for breast cancer at 270 hospitals; 6405 of these women were surveyed about their quality of life 18 months after surgery. Breast appearance, emotional well-being, and physical well-being were quantified on 0- to 100-point scales. Linear multiple regression models, controlling for a range of baseline prognostic factors, were used to compare the scores of patients who had complications with the scores of those who did not. RESULTS: The overall complication rate was 10.2%. Complications were associated with little or no impairment in women undergoing mastectomy without reconstruction or with delayed reconstruction. The association was much larger for flap-related complications suffered during immediate reconstruction. The breast-appearance scores (adjusted mean difference, -23.8; 95% confidence interval [CI], -31.0 to -16.6) and emotional well-being scores (adjusted mean difference, -14.0; 95% CI, -22.0 to -6.0) of these patients were much lower than those of any other patient group. Implant-related complications were not associated with a lower quality of life in any surgical group. CONCLUSIONS: There is a strong case for prospectively collecting flap-complication rates at the surgeon and surgical unit level and for allowing patients to access these data when they make choices about their breast cancer surgery. Cancer 2017;123:3460-7. © 2017 American Cancer Society.

Surgical Determinants of Patient-Reported Outcomes following Postmastectomy Reconstruction in Women with Breast Cancer.

BACKGROUND: This national prospective cohort study compared the patient-reported outcomes of breast cancer patients undergoing postmastectomy autologous reconstruction to those who had breast implants, in terms of aesthetic appearance; levels of psychological, physical, and sexual well-being; and overall satisfaction. METHODS: Of 5063 women who underwent immediate reconstruction (n = 3349) or delayed reconstruction (n = 1714) between January 1, 2008, and March 31, 2009, in England, 2923 women who gave informed consent were sent validated, procedure-specific, 18-month follow-up questionnaires. Outcome scale scores ranged from 0 (poor) to 100 (excellent); multiple linear regression was used to adjust scores for patient and treatment characteristics. RESULTS: Two thousand two hundred eighty-nine women (78 percent) returned completed questionnaires (immediate reconstruction, n = 1528; delayed reconstruction, n = 761). For immediate reconstruction, mean overall satisfaction scores for the various techniques ranged from 67 to 85 (median, 67 to 93). For delayed reconstruction, mean overall satisfaction scores ranged from 70 to 85 (median, 75 to 100). For both groups, similar gradients were observed for the other outcome scales across techniques. Reconstruction using patients' own tissues tended to have higher mean adjusted scores compared with those techniques using implants alone (p < 0.0001 for aesthetic appearance, psychological well-being, sexual well-being, and satisfaction with outcomes for immediate and delayed reconstruction groups). CONCLUSIONS: Women who underwent autologous reconstruction tended to report greater satisfaction than those who underwent implant reconstruction. These results can inform patients of the anticipated outcomes of their selected surgery, but further research is required to confirm whether autologous reconstruction is superior in general. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.