Pediatric patient engagement in clinical care, research and intervention development: a scoping review.

BACKGROUND: In the last decades, pediatric patient engagement has received growing attention and its importance is increasingly acknowledged. Pediatric patient engagement in health care can be defined as the involvement of children and adolescents in the decision-making of daily clinical care, research and intervention development. Although more attention is paid to pediatric patient engagement, a comprehensive overview of the activities that have been done regarding pediatric patient engagement and the changes over time is lacking. Therefore, the aim of this study is to provide an overview of the literature about pediatric patient engagement. METHODS: The methodological framework of Arksey & O'Malley was used to conduct this scoping review. The bibliographic databases Medline, Embase, and PsycINFO were searched for eligible articles. All retrieved articles were screened by at least two researchers in two steps. Articles were included if they focused on pediatric patient engagement, were carried out in the context of clinical care in pediatrics, and were published as full text original article in English or Dutch. Data (year of publication, country in which the study was conducted, disease group of the participants, setting of pediatric patient engagement, used methods, and age of participants) were extracted, synthesized, and tabulated. RESULTS: A total of 288 articles out of the 10,714 initial hits met the inclusion criteria. Over the years, there has been an increase in the number of studies that engage pediatric patients. Pediatric patients, especially patients with multiple conditions or oncology patients, were most involved in studies in the United States, United Kingdom, and Canada. Pediatric patients were most often asked to express their views on questions from daily clinical care and the individual interview was the most used method. In general, the extent to which pediatric patients are engaged in health care increases with age. DISCUSSION: This scoping review shows that there is an increasing interest in pediatric patient engagement. However, lack of uniformity about the definition of pediatric patient engagement and clear information for clinicians hinders engagement. This overview can inform clinicians and researchers about the different ways in which pediatric patient engagement can be shaped and can guide them to engage pediatric patients meaningfully in their projects.

Patient & Caregiver Experiences: Qualitative Study Comparison Before and After Implementation of Early Palliative Care for Advanced Colorectal Cancer.

BACKGROUND: The Palliative Care Early and Systematic (PaCES) program implemented an early palliative care pathway for advanced colorectal cancer patients in January 2019, to increase specialist palliative care consultation and palliative homecare referrals more than three months before death. This study aimed to understand the experience of patients with advanced colorectal cancer and family caregivers who received early palliative care supports from a specialist palliative care nurse and compared those experiences with participants who experienced standard oncology care prior to implementation of early palliative care. METHODS: This was a qualitative and patient-oriented study. We conducted semi-structured telephone interviews with two cohorts of patients with advanced colorectal cancer before and after implementation of an early palliative care pathway. We conducted a thematic analysis of the transcripts guided by a Person-Centred Care Framework. RESULTS: Seven patients living with advanced colorectal cancer and five family caregivers who received early palliative care supports expressed that visits from their early palliative care nurse was helpful, improved their understanding of palliative care, and improved their care. Four main themes shaped their experience of early palliative care: care coordination, perception of palliative care & advance care planning, coping with advanced cancer, and patient and family engagement. These findings were compared with experiences of 15 patients and seven caregivers prior to pathway implementation. CONCLUSION: An early palliative care pathway can improve advanced cancer care, and improve understanding and acceptance of early palliative care. This work was conducted in the context of colorectal cancer but may have relevance for the care of other advanced cancers.

The impacts of partnering with cancer patients in palliative care research: a systematic review and meta-synthesis.

Background: Palliative care (PC) is an added layer of support provided concurrently with cancer care and serves to improve wellbeing and sustain quality of life. Understanding what is meaningful and a priority to patients, their families, and caregivers with lived experience of cancer and PC is critical in supporting their needs and improving their care provision. However, the impacts of engaging cancer patients within the context of PC research remain unknown. Objective: To examine the impacts of engaging individuals with lived experience of cancer and PC as partners in PC research. Methods: An a priori systematic review protocol was registered with PROSPERO (CRD42021286744). Four databases (APA PsycINFO, CINAHL, EMBASE, and MEDLINE) were searched and only published, peer-reviewed primary English studies aligned with the following criteria were included: (1) patients, their families, and/or caregivers with lived experience of cancer and PC; (2) engaged as partners in PC research; and (3) reported the impacts of engaging cancer PC patient partners in PC research. We appraised the quality of eligible studies using the Critical Appraisal Skills Program (CASP) and GRIPP2 reporting checklists. Results: Three studies that included patient partners with lived experience of cancer and PC engaged at all or several of the research stages were identified. Our thematic meta-synthesis revealed impacts (benefits and opportunities) on patient partners (emotional, psychological, cognitive, and social), the research system (practical and ethical) and health care system (service improvements, bureaucratic attitudes, and inaction). Our findings highlight the paucity of evidence investigating the impacts of engaging patients, their families and caregivers with lived experience of cancer and PC, as partners in PC research. Conclusions: The results of this review and meta-synthesis can inform the more effective design of cancer patient partnerships in PC research and the development of feasible and effective strategies given the cancer and PC context patient partners are coming from.

Including the voice of paediatric patients: Cocreation of an engagement game.

BACKGROUND: Engaging patients in health care, research and policy is essential to improving patient-important health outcomes and the quality of care. Although the importance of patient engagement is increasingly acknowledged, clinicians and researchers still find it difficult to engage patients, especially paediatric patients. To facilitate the engagement of children and adolescents in health care, the aim of this project is to develop an engagement game. METHODS: A user-centred design was used to develop a patient engagement game in three steps: (1) identification of important themes for adolescents regarding their illness, treatment and hospital care, (2) evaluation of the draft version of the game and (3) testing usability in clinical practice. Adolescents (12-18 years) were engaged in all steps of the development process through focus groups, interviews or a workshop. These were audio-recorded, transcribed verbatim and analysed in MAXQDA. RESULTS: (1) The important themes for adolescents (N = 15) were included: visiting the hospital, participating, disease and treatment, social environment, feelings, dealing with staff, acceptation, autonomy, disclosure and chronically ill peers. (2) Then, based on these themes, the engagement game was developed and the draft version was evaluated by 13 adolescents. Based on their feedback, changes were made to the game (e.g., adjusting the images and changing the game rules). (3) Regarding usability, the pilot version was evaluated positively. The game helped adolescents to give their opinion. Based on the feedback of adolescents, some last adjustments (e.g., changing colours and adding a game board) were made, which led to the final version of the game, All Voices Count. CONCLUSIONS: Working together with adolescents, All Voices Count, a patient engagement game was developed. This game provides clinicians with a tool that supports shared decision-making to address adolescents' wishes and needs. PATIENT OR PUBLIC CONTRIBUTION: Paediatric patients, clinicians, researchers, youth panel of Fonds NutsOhra and patient associations (Patient Alliance for Rare and Genetic Diseases, Dutch Childhood Cancer Organization) were involved in all phases of the development of the patient engagement game-from writing the project plan to the final version of the game.

Categorising patient concerns using natural language processing techniques.

OBJECTIVES: Patient feedback is critical to identify and resolve patient safety and experience issues in healthcare systems. However, large volumes of unstructured text data can pose problems for manual (human) analysis. This study reports the results of using a semiautomated, computational topic-modelling approach to analyse a corpus of patient feedback. METHODS: Patient concerns were received by Alberta Health Services between 2011 and 2018 (n=76 163), regarding 806 care facilities in 163 municipalities, including hospitals, clinics, community care centres and retirement homes, in a province of 4.4 million. Their existing framework requires manual labelling of pre-defined categories. We applied an automated latent Dirichlet allocation (LDA)-based topic modelling algorithm to identify the topics present in these concerns, and thereby produce a framework-free categorisation. RESULTS: The LDA model produced 40 topics which, following manual interpretation by researchers, were reduced to 28 coherent topics. The most frequent topics identified were communication issues causing delays (frequency: 10.58%), community care for elderly patients (8.82%), interactions with nurses (8.80%) and emergency department care (7.52%). Many patient concerns were categorised into multiple topics. Some were more specific versions of categories from the existing framework (eg, communication issues causing delays), while others were novel (eg, smoking in inappropriate settings). DISCUSSION: LDA-generated topics were more nuanced than the manually labelled categories. For example, LDA found that concerns with community care were related to concerns about nursing for seniors, providing opportunities for insight and action. CONCLUSION: Our findings outline the range of concerns patients share in a large health system and demonstrate the usefulness of using LDA to identify categories of patient concerns.

Eliciting Patient Experiences About Their Care After Cardiac Surgery.

BACKGROUND: Experience surveys provide an opportunity for patients to give their feedback about health care processes and services. Unfortunately, the most current surveys have been designed as "one-size fits-all" tools, and thus, do not take into account items pertaining to specific clinical groups. The objective of this study was to gain a deeper understanding of the specific aspects of care deemed important to cardiac surgery patients. METHODS: Individual semistructured telephone interviews were conducted with a cohort of patients who had previously underwent cardiac surgery. Interviews were recorded and transcribed. Using a phenomenological approach, a thematic analysis was used to generate a list of themes and subthemes deemed important by participants. RESULTS: Eight interviews were conducted in July and August 2019. Participants included 7 men and 1 woman, ranging from 55 to 84 years of age. Five key themes emerged from the data: (1) overall experience; (2) communication; (3) the physical hospital environment; (4) care needs and ongoing management; and (5) person-centred care. Our interviews revealed that participants had many overwhelmingly positive experiences with care. Through reports of their own experiences, participants highlighted important areas that might be improved. CONCLUSIONS: Our results confirm and expand upon those highlighted in quantitative research by our group. Findings and knowledge derived from this study might be used to inform quality improvement activities. These might also play a key role in the development of a patient experience survey, specifically for those who undergo cardiac surgery; thus addressing a potential limitation of surveys currently in use.

CONTEXTE: Les sondages sur l'expérience offrent l'occasion aux patients de transmettre leur point de vue au sujet des services et des processus de soins de santé. Malheureusement, la plupart des sondages actuels sont conçus comme des outils universels, et ne prenent donc pas en considération certains aspects propres à des groupes cliniques précis. L'objectif de cette étude est de mieux cerner les aspects précis des soins qui sont jugés importants par les patients qui ont subi une intervention chirurgicale cardiaque. MÉTHODOLOGIE: Des entretiens téléphoniques individuels semi-structurés ont été menés avec une cohorte de patients ayant subi une intervention chirurgicale cardiaque. Les entretiens ont été enregistrés et retranscrits. Une analyse thématique utilisant une approche phénoménologique a été effectuée pour générer une liste de thèmes et de sous-thèmes jugés importants par les participants. RÉSULTATS: Huit entretiens ont été réalisés en juillet et en août 2019. Les participants regroupaient sept hommes et une femme, âgés de 55 à 84 ans. Les données recueillies ont permis de cerner cinq thèmes clés : 1) expérience globale; 2) communication; 3) environnement physique à l'hôpital; 4) besoins en matière de soins et prise en charge continue; et 5) soins axés sur le patient. Nos entretiens ont révélé que les participants avaient eu plusieurs expériences de soins extrêmement positives. En relatant leurs propres expériences, les participants ont souligné d'importants aspects qui pourraient être améliorés. CONCLUSIONS: Nos résultats confirment ceux des recherches quantitatives effectuées par notre groupe, et viennent les étayer. Les données et les résultats générés par cette étude pourraient être utilisés pour mettre au point des mesures visant l'amélioration de la qualité. Ils pourraient également jouer un rôle important dans la création d'un sondage sur l'expérience des patients, et plus précisément l'expérience des patients ayant subi une intervention chirurgicale cardiaque, et ainsi remédier aux limites possibles des sondages utilisés à l'heure actuelle.

Patient-led use of patient-reported outcome measure in self-Management of a Rotator Cuff Injury.

INTRODUCTION: The patient is the person who experiences both the processes and the outcomes of care. Information held by the patient is vital for clinical and self-management, improving health outcomes, delivery of care, organization of health systems, and formulation of health policies. Patient-reported outcome measures (PROMs) play an important role in supporting patient's self-management. This narrative describes a patient-led use of a PROM to self-manage after a rotator cuff injury. METHODS: This is a narrative of a patient who tore the supraspinatus tendon in her right shoulder in an accident. The Disabilities of the Arm, Shoulder and Hand, the DASH questionnaire, was used to monitor and self-manage recovery after the accident. The DASH questionnaire is a self-reported questionnaire that measures the difficulty in performing upper extremity activities and pain in the arm, shoulder or hand. It has been widely used in research studies, but here the patient initiated its use for self-management while waiting for and after rotator cuff surgery. The patient created separate sub-scale scores for function and for pain to answer questions from healthcare providers about her recovery. RESULTS: There was noticeable improvement over 3 months of conservative treatment, from a high level of disability of 56 to 39 (score changed 17); however, the scores were nowhere near the general population normative score of 10.1. Surgery improved the score from 39 pre-surgery to 28. Post-surgical interventions included physiotherapy, pain management and platelet-riched plasma treatment (PRP). The score was 14 4 weeks post-PRP. CONCLUSIONS: The patient found the DASH useful in monitoring recovery from a rotator cuff injury (before and after surgery). The DASH contributed to communication with healthcare professionals and supported the clinical management. The DASH questionnaire was able to capture the patient's experience with the injury and surgical recovery, corroborating an improvement in function while there was persistent post-surgical pain.

Prevalence of comorbidities among individuals with COVID-19: A rapid review of current literature.

INTRODUCTION: On February 11, 2020 WHO designated the name "COVID-19" for the disease caused by "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2), a novel virus that quickly turned into a global pandemic. Risks associated with acquiring the virus have been found to most significantly vary by age and presence of underlying comorbidity. In this rapid literature review we explore the prevalence of comorbidities and associated adverse outcomes among individuals with COVID-19 and summarize our findings based on information available as of May 15, 2020. METHODS: A comprehensive systematic search was performed on PubMed, Medline, Scopus, Embase, and Google Scholar to find articles published until May 15, 2020. All relevant articles providing information on PCR tested COVID-19 positive patient population with clinical characteristics and epidemiological information were selected for review and analysis. RESULTS: A total of 27 articles consisting of 22,753 patient cases from major epicenters worldwide were included in the study. Major comorbidities seen in overall population were CVD (8.9%), HTN (27.4%), Diabetes (17.4%), COPD (7.5%), Cancer (3.5%), CKD (2.6%), and other (15.5%). Major comorbidity specific to countries included in the study were China (HTN 39.5%), South Korea (CVD 25.6%), Italy (HTN 35.9%), USA (HTN 38.9%), Mexico, (Other 42.3%), UK (HTN 27.8%), Iran (Diabetes 35.0%). Within fatal cases, an estimated 84.1% had presence of one or more comorbidity. Subgroup analysis of fatality association with having comorbidity had an estimated OR 0.83, CI [0.60-0.99], p<0.05. CONCLUSIONS: Based on our findings, hypertension followed by diabetes and cardiovascular diseases were the most common comorbidity seen in COVID-19 positive patients across major epicenters world-wide. Although having one or more comorbidity is linked to increased disease severity, no clear association was found between having these risk factors and increased risk of fatality.

Effects of Wait Times on Treatment Adherence and Clinical Outcomes in Patients With Severe Sleep-Disordered Breathing: A Secondary Analysis of a Noninferiority Randomized Clinical Trial.

Importance: Sleep-disordered breathing (SDB) is common and associated with substantial adverse health consequences. Long wait times for SDB care are commonly reported; however, it is unclear whether wait times for care are associated with clinical outcomes. Objective: To evaluate the association of wait times for care with clinical outcomes for patients with severe SDB. Design, Setting, and Participants: This study is a secondary analysis of a randomized clinical noninferiority trial comparing management by alternative care practitioners (ACPs) with traditional sleep physician-led care between October 2014 and May 2017. The study took place at Foothills Medical Centre Sleep Centre, a tertiary care multidisciplinary sleep clinic at the University of Calgary. Patients with severe SDB (defined as a respiratory event index ≥30 events per hour during home sleep apnea testing, mean nocturnal oxygen saturation ≤85%, or suspected sleep hypoventilation syndrome) were recruited for the study. Patients were excluded if they were suspected of having a concomitant sleep disorder other than SDB or had previously been treated with positive airway pressure (PAP) therapy for SDB. Data were analyzed from October 2017 to January 2020. Main Outcomes and Measures: Outcomes were assessed 3 months after treatment initiation with adherence to PAP therapy as the primary outcome. Secondary outcomes included Epworth Sleepiness Scale score, health-related quality of life, and patient satisfaction measured using the Visit-Specific Satisfaction Instrument-9. Multiple regression models were used to assess the associations between wait times and each of the outcomes. t tests were used to compare wait times for patients who were adherent to PAP therapy (≥4 hours per night for 70% of nights) with those for nonadherent patients. Results: One hundred fifty-six patients (112 [71.8%] men; mean [SD] age, 56 [12] years) were included in the analysis. The mean time from referral to initial visit was 88 days (95% CI, 79 to 96 days), and the mean time to treatment was 123 days (95% CI, 112 to 133 days). Shorter wait time to treatment initiation was associated with adherence to PAP therapy (odds ratio, 0.99; 95% CI, 0.98 to 0.99; P = .04), greater improvement in Epworth Sleepiness Scale score (mean coefficient, -9.37; 95% CI, -18.51 to -0.24; P = .04), and higher Visit-Specific Satisfaction Instrument-9 score (mean coefficient, -0.024; 95% CI, -0.047 to -0.0015; P = .04) at 3 months. Compared with nonadherent patients, those who were adherent to treatment waited a mean of 15 fewer days (95% CI, 12 to 19 days) for initial assessment (P = .07) and 30 fewer days (95% CI, 23 to 35 days) for treatment initiation (P = .008). Conclusions and Relevance: Earlier initiation of treatment for severe SDB was associated with better PAP adherence and greater improvements in daytime sleepiness and patient satisfaction. These findings suggest that system interventions to improve timely access may modify patient behavior and improve clinical outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT02191085.

Patient-Reported Experiences With Coronary Artery Bypass Grafting and Valve Replacement.

BACKGROUND: The Canadian Patient Experience Survey-Inpatient Care is a validated measure for adult inpatient experience. Linking surveys with administrative data can examine the experience of patients in specific demographic or clinical groups. METHODS: We examined survey responses obtained over a 4-year period from patients who underwent coronary artery bypass graft and/or valve replacement in Alberta. The 56-question telephone survey was administered within 6 weeks of discharge. Surveys were linked with administrative records to identify the Canadian Classification of Intervention procedure codes, which were in scope. Responses to each question were reported as percentage in "top box," where "top box" represents the most positive answer choice (eg, "always" and "yes"). RESULTS: From April 2014 to March 2018, 1082 surveys were completed by patients who underwent coronary artery bypass graft and/or valve replacement. Respondents were predominantly male (73.8%), with a mean age of 64.7 ± 11.9 years. Overall, 73.3% of respondents rated their hospital care as 9 or 10 out of 10 (best), and 86.2% would "definitely recommend" the hospital to friends/family members. Top performing questions pertained to having a discussion about help needed after discharge (96.6% responding "yes") and receiving written discharge information (93.2% responding "yes"). Lack of quietness of the hospital environment at night (34.8% responding "always") and lack of staff sufficiently describing side effects of new medications (44.9% responding "always") were identified as potential areas for improvement. CONCLUSIONS: Our results provide patient-reported experiences about inpatient cardiac care in Alberta hospitals. The findings could inform quality improvement initiatives that are patient-centred.

Multicenter validation of the Quality of Trauma Care Patient-Reported Experience Measure (QTAC-PREM).

BACKGROUND: Incorporating patient and family perspectives into injury care quality assessment is a necessary part of comprehensive quality improvement. However, tools to measure patient and family perspectives of injury care are lacking. Therefore, our objective was to assess the psychometric properties of the Quality of Trauma Care Patient-Reported Experience Measure (QTAC-PREM), the first measure developed to assess patient experiences with overall injury care. METHODS: We conducted a prospective multicenter cohort study of adult injury patients recruited from three trauma centers. Patients or surrogates completed an acute care survey measure in the hospital and a post-acute care survey measure after hospital discharge. RESULTS: Four hundred participants (78%) completed the acute care measure, and 207 (59%) completed the post-acute care measure. We identified three subscales on the acute measure and two subscales on the post-acute measure. All subscales and items had evidence of construct validity. Four subscales had good internal consistency, and three were independent predictors of participants' overall ratings of injury care quality. The majority of items demonstrated suitable test-retest reliability. Comparison of QTAC-PREM scores with those of an existing patient experience tool, the Hospital version of the Consumer Assessment of Healthcare Providers and Systems (HCAHPS), demonstrated evidence of appropriate divergent and convergent validity. CONCLUSION: This study demonstrates that the QTAC-PREM is feasible to implement at trauma centers and provides evidence of validity and reliability. The tool may be useful to incorporate patient perspectives into trauma care quality measurement and improvement.

Training clinicians in how to use patient-reported outcome measures in routine clinical practice.

INTRODUCTION: Patient-reported outcome measures (PROs) were originally developed for comparing groups of people in clinical trials and population studies, and the results were used to support treatment recommendations or inform health policy, but there was not direct benefit for the participants providing PROs data. However, as the experience in using those measures increased, it became obvious the clinical value in using individual patient PROs profiles in daily practice to identify/monitor symptoms, evaluate treatment outcomes and support shared decision-making. A key issue limiting successful implementation is clinicians' lack of knowledge on how to effectively utilize PROs data in their clinical encounters. METHODS: Using a change management theoretical framework, this paper describes the development and implementation of three programs for training clinicians to effectively use PRO data in routine practice. The training programs are in three diverse clinical areas (adult oncology, lung transplant and paediatrics), in three countries with different healthcare systems, thus providing a rare opportunity to pull out common approaches whilst recognizing specific settings. For each program, we describe the clinical and organizational setting, the program planning and development, the content of the training session with supporting material, subsequent monitoring of PROs use and evidence of adoption. The common successful components and practical steps are identified, leading to discussion and future recommendations. RESULTS: The results of the three training programs are described as the implementation. In the oncology program, PRO data have been developed and are currently evaluated; in the lung transplant program, PRO data are used in daily practice and the integration with electronic patient records is under development; and in the paediatric program, PRO data are fully implemented with around 7,600 consultations since the start of the implementation. CONCLUSION: Adult learning programs teaching clinicians how to use and act on PROs in clinical practice are a key steps in supporting patient engagement and participation in shared decision-making. Researchers and clinicians from different clinical areas should collaborate to share ideas, develop guidelines and promote good practice in patient-centred care.

Development and evaluation of evidence-informed quality indicators for adult injury care.

OBJECTIVE: To develop and evaluate evidence-informed quality indicators of adult injury care. BACKGROUND: Injury is a leading cause of morbidity and mortality, but there is a lack of consensus regarding how to evaluate injury care. METHODS: Using a modification of the RAND/UCLA Appropriateness Methodology, a panel of 19 injury and quality of care experts serially rated and revised quality indicators identified from a systematic review of the literature and international audit of trauma center quality improvement practices. The quality indicators developed by the panel were sent to 133 verified trauma centers in the United States, Canada, Australia, and New Zealand for evaluation. RESULTS: A total of 84 quality indicators were rated and revised by the expert panel over 4 rounds of review producing 31 quality indicators of structure (n=5), process (n=21), and outcome (n=5), designed to assess the safety (n=8), effectiveness (n=17), efficiency (n=6), timeliness (n=16), equity (n=2), and patient-centeredness (n=1) of injury care spanning prehospital (n=8), hospital (n=19), and posthospital (n=2) care and secondary injury prevention (n=1). A total of 101 trauma centers (76% response rate) rated the indicators (1=strong disagreement, 9=strong agreement) as targeting important health improvements (median score 9, interquartile range [IQR] 8-9), easy to interpret (median score 8, IQR 8-9), easy to implement (median score 8, IQR 7-8), and globally good indicators (median score 8, IQR 8-9). CONCLUSIONS: Thirty-one evidence-informed quality indicators of adult injury care were developed, shown to have content validity, and can be used as performance measures to guide injury care quality improvement practices.

Health-related quality of life with adjuvant docetaxel- and trastuzumab-based regimens in patients with node-positive and high-risk node-negative, HER2-positive early breast cancer: results from the BCIRG 006 Study.

BACKGROUND: This study aims to describe and compare health-related quality of life (HRQL) in patients with node-positive and high-risk node-negative HER2-positive early breast cancer receiving adjuvant docetaxel and trastuzumab-based or docetaxel-based regimens alone. METHODS: Eligible patients (n = 3,222) were randomly assigned to either four cycles of adjuvant doxorubicin and cyclophosphamide followed by four cycles of docetaxel (AC→T) or one of two trastuzumab-containing regimens: adjuvant doxorubicin and cyclophosphamide followed by docetaxel plus trastuzumab administered for 1 year (AC→TH) or six cycles of docetaxel plus carboplatin combined with trastuzumab administered for 1 year (TCH). The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 and BR-23 were administered at baseline, the start of cycle 4 (mid), and the end of chemotherapy (EOC), as well as at 6, 12, and 24 months after chemotherapy. RESULTS: Compliance rates for the EORTC questionnaires were acceptable at 72%-93% of eligible patients out to the 12-month assessment. Systemic side effect (SE) change scores were significantly improved for TCH-treated patients compared with AC→TH and AC→T at EOC, suggesting improved tolerability. Physical functioning (PF) was only slightly worse at midpoint for those receiving TCH, compared with patients who were just starting on taxane in an AC→TH regimen, but was otherwise similar between arms. All treatment arms recovered from the deterioration in SE, PF, and Global Health Scale scores by 1 year and median future perspective change scores continued to improve throughout treatment and follow-up. CONCLUSION: HRQL outcomes for adjuvant docetaxel and trastuzumab-based regimens are favorable and support TCH as a more tolerable treatment option.