Role-model, reoffer, reward: A thematic analysis and TDF mapping of influences on families' use of evidence-based vegetable feeding practices.

Children's vegetable intake is low, despite benefits for immediate and long-term health. Repeatedly reoffering vegetables, role-modelling consumption, and offering non-food rewards effectively increase children's vegetable acceptance and intake. However, a number of barriers prevent families from reoffering previously-rejected vegetables. This study used the Theoretical Domains Framework (TDF) and the COM-B model of behaviour to explore barriers and enablers to reoffering, role-modelling and offering non-food rewards among parents of 2-4-year-old children. Twenty-five semi-structured interviews were conducted, from which eleven core inductive themes were generated: 'Child factors', 'Eating beliefs', 'Effectiveness beliefs', 'Past experience', 'Current family behaviours', 'Harms', 'Knowledge', 'Need for change', 'Parent effort', 'Parent values' and 'Practical issues'. The codes underpinning these themes were inductively mapped to 11 of the 14 TDF domains, and five of the six COM-B components. Previously-reported influences on families' vegetable feeding practices were confirmed, including concerns about child rejection of foods/meals, cost of vegetables, and food waste. Novel findings included some parents' perceptions that these practices are pressurising, and that certain beliefs/knowledge about children's eating behaviour can provide a "protective mindset" that supports families' perseverance with reoffering over time. Future interventions should be tailored to better reflect the diversity of needs and previous experiences of feeding that families have, with some families likely to find that troubleshooting and further signposting is appropriate for their needs while others might benefit from more persuasive and educational approaches. The mapping of codes to the TDF and COM-B will facilitate the identification of appropriate intervention functions and behaviour change techniques when designing new interventions to support families with increasing their children's vegetable intake.

Development and External Validation of a Prediction Model for Quality of Life of ICU Survivors: A Subanalysis of the MONITOR-IC Prospective Cohort Study.

OBJECTIVES: To develop and externally validate a prediction model for ICU survivors' change in quality of life 1 year after ICU admission that can support ICU physicians in preparing patients for life after ICU and managing their expectations. DESIGN: Data from a prospective multicenter cohort study (MONITOR-IC) were used. SETTING: Seven hospitals in the Netherlands. PATIENTS: ICU survivors greater than or equal to 16 years old. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Outcome was defined as change in quality of life, measured using the EuroQol 5D questionnaire. The developed model was based on data from an academic hospital, using multivariable linear regression analysis. To assist usability, variables were selected using the least absolute shrinkage and selection operator method. External validation was executed using data of six nonacademic hospitals. Of 1,804 patients included in analysis, 1,057 patients (58.6%) were admitted to the academic hospital, and 747 patients (41.4%) were admitted to a nonacademic hospital. Forty-nine variables were entered into a linear regression model, resulting in an explained variance ( R2 ) of 56.6%. Only three variables, baseline quality of life, admission type, and Glasgow Coma Scale, were selected for the final model ( R2 = 52.5%). External validation showed good predictive power ( R2 = 53.2%). CONCLUSIONS: This study developed and externally validated a prediction model for change in quality of life 1 year after ICU admission. Due to the small number of predictors, the model is appealing for use in clinical practice, where it can be implemented to prepare patients for life after ICU. The next step is to evaluate the impact of this prediction model on outcomes and experiences of patients.

Co-Design of a Reusable Learning Object (RLO) to Address Caregiver Responsive Infant Feeding Behaviours (CRIB) to Prevent Childhood Obesity: A Mixed-Method Protocol.

Responsive infant feeding is a key strategy for childhood obesity prevention. Responsive feeding involves caregivers responding to infant hunger and satiety cues in a timely and developmentally appropriate manner. There is a dearth of evidence-based information and guidance for caregivers on how to responsively feed their infants. The aim of this research is to co-design a Reusable Learning Object (RLO) and guidance infographic to improve caregiver awareness, understanding and use of responsive infant feeding behaviours. The Capability, Opportunity, Motivation and Behaviour (COM-B) model of behaviour change and the Aim, Storyboarding, Populate specification, Implement media, Review and release prototype, and Evaluate (ASPIRE) approach for digital intervention co-design will be utilised. Four co-design workshops with caregivers of infants and healthcare professionals (HCPs) will determine priority RLO content. Content analysis will enable RLO development and process reporting. Formative and summative surveys will be conducted to evaluate the usability of the RLO, its impact on caregivers and its potential implementation into NHS care pathways. The output will be a RLO on responsive feeding for caregivers and an infographic for HCPs/support workers which will contribute to a future obesity prevention intervention. The findings will be disseminated to stakeholders and submitted for publication in a peer-reviewed journal.

Encouraging healthier grocery purchases online: A randomised controlled trial and lessons learned.

Online supermarket platforms present an opportunity for encouraging healthier consumer purchases. A parallel, double-blind randomised controlled trial tested whether promoting healthier products (e.g. lower fat and lower calorie) on the Sainsbury's online supermarket platform would increase purchases of those products. Participants were Nectar loyalty membership scheme cardholders who shopped online with Sainsbury's between 20th September and 10th October 2017. Intervention arm customers saw advertisement banners and recipe ingredient lists containing healthier versions of the products presented in control arm banners and ingredient lists. The primary outcome measure was purchases of healthier products. Additional outcome measures were banner clicks, purchases of standard products, overall purchases and energy (kcal) purchased. Sample sizes were small due to customers navigating the website differently than expected. The intervention encouraged purchases of some promoted healthier products (spaghetti [B = 2.10, p < 0.001], spaghetti sauce [B = 2.06, p < 0.001], spaghetti cheese [B = 2.45, p = 0.001], sour cream [B = 2.52, p < 0.001], fajita wraps [B = 2.10, p < 0.001], fajita cheese [B = 1.19, p < 0.001], bakery aisle products (B = 3.05, p = 0.003) and cola aisle products [B = 0.97, p < 0.002]) but not others (spaghetti mince, or products in the yogurt and ice cream aisles). There was little evidence of effects on banner clicks and energy purchased. Small sample sizes may affect the robustness of these findings. We discuss the benefits of collaborating to share expertise and implement a trial in a live commercial environment, alongside key learnings for future collaborative research in similar contexts.

The impact of COVID-19 on the eating habits of families engaged in a healthy eating pilot trial: a thematic analysis.

BACKGROUND: The eating habits of children and adults have been impacted by the COVID-19 pandemic, with evidence of increases in snacking and emotional eating, including eating to relieve boredom. We explored the experiences of families with children aged 4-8 years who had recently participated in a healthy eating pilot trial when the first national lockdown began in England. METHODS: Eleven mothers were interviewed in April and May 2020. Interview questions were developed based on the COM-B model of behaviour. Four main themes were constructed using inductive thematic analysis. RESULTS: The first theme related to an initial panic phase, in which having enough food was the primary concern. The second related to ongoing challenges during the lockdown, with sub-themes including difficulties accessing food, managing children's food requests and balancing home and work responsibilities. The perception that energy-dense foods met families' needs during this time led to increased purchasing of (and thus exposure to) energy-dense foods. In the third theme, families described a turning point, with a desire to eat a healthier diet than they had in the early stages of the lockdown. Finally, in the fourth theme, families reported a number of strategies for adapting and encouraging a balanced diet with their children. CONCLUSIONS: Our results suggest that even if parents have the capability (e.g. knowledge) and motivation to provide a healthy diet for their family, opportunity challenges (e.g. time, access to resources, environmental stressors) mean this is not always practical. Healthy eating interventions should not assume parents lack motivation and should be sensitive to the context within which parents make feeding decisions.

Interventions to change purchasing behaviour in supermarkets: a systematic review and intervention content analysis.

This systematic review and intervention content analysis used behavioural science frameworks to characterise content and function of interventions targeting supermarket shoppers' purchasing behaviour, and explore if coherence between content and function was linked to intervention effectiveness. Study eligibility: in-store interventions (physical supermarkets) with control conditions, targeting objectively measured food and/or non-alcoholic drink purchases, published in English (no date restrictions). Eleven electronic databases were searched; reference lists of systematic reviews were hand-searched. Methodological quality was assessed using the GATE checklist. A content analysis was performed to characterise intervention content and function, and theoretical coherence between these, using the Behaviour Change Wheel, Behaviour Change Techniques Taxonomy, and Typology of Interventions in Proximal Physical Micro-Environments (TIPPME). Forty-six articles (49 interventions) met inclusion criteria; 26 articles (32 interventions) were included in the content analysis. Twenty behaviour change techniques (BCTs), and four TIPPME intervention types were identified; three BCTs ('Prompts/cues', 'Material incentive', and 'Material reward') were more common in effective interventions. Nineteen interventions solely employed theoretically appropriate BCTs. Theoretical coherence between BCTs and intervention functions was more common in effective interventions. Effective interventions included price promotions and/or in-store merchandising. Future research should explore the effect of specific BCTs using factorial study designs. PROSPERO Registration: CRD42017071065.

Optimizing Making Every Contact Count (MECC) interventions: A strategic behavioral analysis.

OBJECTIVE: This Strategic Behavioral Analysis aimed to: identify barriers and facilitators to health care professionals' implementation of Making Every Contact Count (MECC); code behavioral components of nationally delivered interventions to improve MECC implementation; assess the extent to which these components are theoretically congruent with identified theoretical domains representing barriers and facilitators. Comparing national interventions that aim to support implementation of behavior change related activity to the barriers and facilitators for the target behavior enables identification of opportunities being missed in practice; thereby, facilitating intervention optimization. METHOD: A mixed-method study involving: a systematic review to identify barriers and facilitators to implementing MECC classified using the COM-B model and Theoretical Domains Framework (TDF); a content analysis of national interventions to improve MECC implementation in England using the Behavior Change Wheel (BCW) and Behavior Change Techniques Taxonomy (BCTTv1); linking intervention content to barriers identified in the systematic review. RESULTS: Across 27 studies, the most frequently reported barriers related to eight TDF domains: Environmental Context and Resources, Beliefs About Capabilities, Knowledge, Beliefs About Consequences, Intentions, Skills, Social Professional Role and Identity, and Emotions. National interventions aimed at supporting MECC implementation included on average 5.1 BCW intervention functions (Education, Modeling, Persuasion, and Training were used in all interventions) and 8.7 BCTs. Only 21% of BCTs potentially relevant to key domains were used across interventions. The majority of BCTs linked to seven of the eight most important domains were not used in any existing interventions. CONCLUSIONS: Intervention developers should seize missed opportunities by incorporating more theoretically relevant BCTs to target barriers to implementing MECC. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Enabling women to access preferred methods of contraception: a rapid review and behavioural analysis.

BACKGROUND: Many pregnancies in the UK are either unplanned or ambivalent. This review aimed to (i) explore barriers and facilitators to women choosing and accessing a preferred method of contraception in the United Kingdom, and (ii) identify opportunities for behavioural interventions based on examination of interventions that are currently available nationally. METHODS: Three databases were searched, and experts contacted to identify grey literature for studies presenting barriers and facilitators to women choosing and accessing a preferred method of contraception, conducted in the UK and published between 2009 and October 2019. Information on barriers and facilitators were coded into overarching themes, which were then coded into Mechanisms of Actions (MoAs) as listed in the Theory and Techniques Tool. National interventions were identified by consulting stakeholders and coded into the Behaviour Change Wheel. The match between barriers/facilitators and intervention content was assessed using the Behaviour Change Wheel. RESULTS: We included 32 studies and identified 46 barrier and facilitator themes. The most cited MoA was Environmental Context and Resources, which primarily related to the services women had access to and care they received. Social Influences, Beliefs about Consequences (e.g., side effects) and Knowledge were also key. The behavioural analysis highlighted four priority intervention functions (Modelling, Enablement, Education and Environmental Restructuring) that can be targeted to support women to choose and access their preferred method of contraception. Relevant policy categories and behaviour change techniques are also highlighted. CONCLUSIONS: This review highlights factors that influence women's choices and access to contraception and recommends opportunities that may be targeted for future interventions in order to support women to access preferred contraception. REGISTRATION: Protocol was registered with PROSPERO (an international database of prospectively registered systematic reviews in health and social care) in December 2019, CRD42019161156 .

Exploring Strategies to Optimise the Impact of Food-Specific Inhibition Training on Children's Food Choices.

Food-specific inhibition training (FSIT) is a computerised task requiring response inhibition to energy-dense foods within a reaction-time game. Previous work indicates that FSIT can increase the number of healthy foods (relative to energy-dense foods) children choose, and decrease calories consumed from sweets and chocolate. Across two studies, we explored the impact of FSIT variations (e.g., different response signals, different delivery modes) on children's food choices within a time-limited hypothetical food-choice task. In Study 1, we varied the FSIT Go/No-Go signals to be emotive (happy vs. sad faces) or neutral (green vs. red signs). One-hundred-and-fifty-seven children were randomly allocated to emotive-FSIT, neutral-FSIT, or a non-food control task. Children participated in groups of 4-15. No significant FSIT effects were observed on food choices (all values of p > 0.160). Healthy-food choices decreased over time regardless of condition (p < 0.050). The non-significant effects could be explained by lower accuracy on energy-dense No-Go trials than in previous studies, possibly due to distraction in the group-testing environment. In Study 2, we compared computer-based FSIT (using emotive signals) and app-based FSIT (using neutral signals) against a non-food control with a different sample of 206 children, but this time children worked one-on-one with the experimenter. Children's accuracy on energy-dense No-Go trials was higher in this study. Children in the FSIT-computer group chose significantly more healthy foods at post-training (M = 2.78, SE = 0.16) compared to the control group (M = 2.02, SE = 0.16, p = 0.001). The FSIT-app group did not differ from either of the other two groups (M = 2.42, SE = 0.16, both comparisons p > 0.050). Healthy choices decreased over time in the control group (p = 0.001) but did not change in the two FSIT groups (both p > 0.300) supporting previous evidence that FSIT may have a beneficial effect on children's food choices. Ensuring that children perform FSIT with high accuracy (e.g., by using FSIT in quiet environments and avoiding group-testing) may be important for impacts on food choices though. Future research should continue to explore methods of optimising FSIT as a healthy-eating intervention for children.

A randomised experiment of health, cost and social norm message frames to encourage acceptance of swaps in a simulation online supermarket.

Offering lower-energy food swaps to customers of online supermarkets could help to decrease energy (kcal) purchased and consumed. However, acceptance rates of such food swaps tend to be low. This study aimed to see whether framing lower-energy food swaps in terms of cost savings or social norms could improve likelihood of acceptance relative to framing swaps in terms of health benefits. Participants (n = 900) were asked to shop from a 12-item shopping list in a simulation online supermarket. When a target high-energy food was identified in the shopping basket at check-out, one or two lower-energy foods would be suggested as an alternative (a "swap"). Participants were randomised to only see messages emphasising health benefits (fewer calories), cost benefits (lower price) or social norms (others preferred this product). Data were analysed for 713 participants after exclusions. Participants were offered a mean of 3.17 swaps (SD = 1.50), and 12.91% of swaps were accepted (health = 14.31%, cost = 11.49%, social norms = 13.18%). Swap acceptance was not influenced by the specific swap frame used (all p > .170). Age was significantly and positively associated with swap acceptance (b = 0.02, SE = 0.00, p < .001), but was also associated with smaller decreases in energy change (b = 0.46, SE = .19, p = .014). Overall, offering swaps reduced both energy (kcal) per product (b = -9.69, SE = 4.07, p = .017) and energy (kcal) per shopping basket (t712 = 11.09, p < .001) from pre- to post-intervention. Offering lower-energy food swaps could be a successful strategy for reducing energy purchased by customers of online supermarkets. Future research should explore alternative solutions for increasing acceptance rates of such swaps.

Using behavioural insights to reduce sugar in primary school children's packed lunches in derby; A cluster randomised controlled trial.

Children's packed lunches contain more sugar than school-provided meals. Interventions to improve the provision of healthier packed lunches have modest effects on lunch contents. This cluster randomised controlled trial tested an intervention to encourage healthier provision of packed lunches by parents of primary school children in Derby. Schools were randomised to intervention (n = 8) or control (n = 9) using blocked random allocation. In the intervention group, parents of children who brought packed lunches to school in years 3-6 (age 7-11 years) received three bundles of materials (including packed lunch planner, shopping list, information on sugar content of popular lunchbox items and suggestions for healthier swap alternatives) in bookbags/lunchboxes over a 4-week period. Control parents received no materials. Photos of lunchbox contents were taken at baseline, immediately post-intervention and at three-month follow-up. A parental survey aimed to assess capability, opportunity and motivation for packing a healthier lunchbox. No intervention effects were observed for primary outcomes (presence and number of sugary snacks or chilled sugary desserts). The intervention had a significant impact on one secondary outcome (increased number of healthier "swap" items suggested in intervention materials) immediately post-intervention, but this effect had disappeared at three-month follow-up. No intervention effects were found on survey variables. Parent comments revealed that materials were either received positively (as they reinforced existing behaviours) or negatively (as they were not perceived to be helpful or appropriate). The results of this study suggest that providing educational materials and resources to parents of primary school children in Derby was not sufficient to increase provision of healthier packed lunches. Future research should investigate how behavioural science can support families to improve the nutritional content of primary school children's lunchboxes.

Respiratory and hemodynamic perioperative adverse events in intravenous versus inhalational induction in pediatric anesthesia: A systematic review and meta-analysis.

Perioperative respiratory and hemodynamic adverse events are still a cause of morbidity and mortality in pediatric anesthesia. It has been suggested that volatile agents might be associated with more respiratory adverse events compared to intravenous agents (eg, propofol), which have been associated with a higher risk of bradycardia compared to volatile agents. We performed a systematic review and meta-analysis to evaluate the risk of perioperative hemodynamic and respiratory adverse events, comparing intravenous induction with inhalational induction in pediatric anesthesia. We searched PubMed, Embase, and Medline up to February 12, 2020. Randomized controlled trials were included. A quality assessment was carried out using a modified version of the "Cochrane Risk of Bias Tool for Randomized Controlled Trials." Of the 1602 applicable publications, four were included in the final review. Two studies found no significant differences in perioperative respiratory or hemodynamic adverse events. Two studies found a higher risk of respiratory perioperative adverse events in inhalation versus intravenous induction, with a relative risk varying from 1.64 to 3.83. Data were heterogenous, and pooled estimates may not be reliable. The present systematic review and meta-analysis revealed no significant difference in the occurrence of perioperative respiratory adverse events between inhalation and intravenous induction. More respiratory adverse events during and after inhalation induction were found, in particular in children with multiple risk factors for respiratory adverse events. This did not reach significance. Future research should include a large randomized controlled trial comparing inhalation and intravenous induction with respiratory and hemodynamic adverse events as primary outcome and adequately blinded outcome assessors.

A systematic review of factors influencing NHS health check uptake: invitation methods, patient characteristics, and the impact of interventions.

BACKGROUND: The NHS Health Check (NHSHC) is a risk assessment for those aged 40-74 without a pre-existing condition in England, with the aim of preventing stroke, kidney disease, heart disease, type 2 diabetes and dementia. Uptake has been lower than anticipated. Ensuring that a high percentage of eligible patients receive a NHSHC is key to optimising the clinical and cost effectiveness of the programme. The aim of this systematic review is to highlight interventions and invitation methods that increase the uptake of NHSHCs, and to identify whether the effectiveness of these interact with broader patient and contextual factors. METHOD: A systematic review was conducted according to the PRISMA checklist. Papers were eligible if they explored the impact of at least one of (i) interventions, (ii) invitation methods or (iii) broader factors on NHSHC uptake. Ten databases were searched in January 2016 and seven were searched in March 2018. Nine-hundred-and-forty-five papers were identified, 238 were screened and 64 full texts were assessed for eligibility. Nine studies were included in the review. RESULTS: The nine studies were all from peer reviewed journals. They included two randomised controlled trials, one observational cohort and six cross-sectional studies. Different invitation methods may be more effective for different groups of patients based on their ethnicity and gender. One intervention to enhance invitation letters effectively increased uptake but another did not. In addition, individual patient characteristics (such as age, gender, ethnicity and risk level) were found to influence uptake. This review also finds that uptake varies significantly by GP practice, which could be due either to unidentified practice-level factors or deprivation. CONCLUSIONS: Further research is needed to assess the effectiveness of different invitation methods for different population groups. Research should examine how existing invitation methods can be enhanced to drive uptake whilst reducing health inequalities. TRIAL REGISTRATION: This systematic review was registered with PROSPERO on 22.02.2016. Registration number CRD42016035626.

Engineering γδT cells limits tonic signaling associated with chimeric antigen receptors.

Despite the benefits of chimeric antigen receptor (CAR)-T cell therapies against lymphoid malignancies, responses in solid tumors have been more limited and off-target toxicities have been more marked. Among the possible design limitations of CAR-T cells for cancer are unwanted tonic (antigen-independent) signaling and off-target activation. Efforts to overcome these hurdles have been blunted by a lack of mechanistic understanding. Here, we showed that single-cell analysis with time course mass cytometry provided a rapid means of assessing CAR-T cell activation. We compared signal transduction in expanded T cells to that in T cells transduced to express second-generation CARs and found that cell expansion enhanced the response to stimulation. However, expansion also induced tonic signaling and reduced network plasticity, which were associated with expression of the T cell exhaustion markers PD-1 and TIM-3. Because this was most evident in pathways downstream of CD3ζ, we performed similar analyses on γδT cells that expressed chimeric costimulatory receptors (CCRs) lacking CD3ζ but containing DAP10 stimulatory domains. These CCR-γδT cells did not exhibit tonic signaling but were efficiently activated and mounted cytotoxic responses in the presence of CCR-specific stimuli or cognate leukemic cells. Single-cell signaling analysis enabled detailed characterization of CAR-T and CCR-T cell activation to better understand their functional activities. Furthermore, we demonstrated that CCR-γδT cells may offer the potential to avoid on-target, off-tumor toxicity and allo-reactivity in the context of myeloid malignancies.

Seasonal influence of environmental variables and artificial aeration on Escherichia coli in small urban lakes.

This study investigated patterns of Escherichia coli in urban lakes in Lubbock, Texas. Specific objectives were to (1) document seasonal patterns in abundance of E. coli over a 3-year period, (2) identify environmental factors, including effects of migratory geese and artificial aeration devices that may influence E. coli abundance, and (3) determine if E. coli abundance over time was similar for individual lakes. Water samples were collected monthly for 36 months from six lakes, three of which contained artificial aeration devices (fountains). Regression models were constructed to determine which environmental variables most influence E. coli abundance in summer and winter seasons. Escherichia coli is present in the lakes of Lubbock, Texas year-round and typically exceeds established bacterial thresholds for recreational waters. Models most frequently contained pH and dissolved oxygen as predictor variables and explained from 17.4% to 92.4% of total variation in E. coli. Lakes with fountains had a higher oxygen concentration during summer and contained consistently less E. coli. We conclude that solar irradiation in synergy with pH and dissolved oxygen is the primary control mechanism for E. coli in study lakes, and that fountains help control abundance of fecal bacteria within these systems.

Double-blind, placebo-controlled, randomised phase II trial of IH636 grape seed proanthocyanidin extract (GSPE) in patients with radiation-induced breast induration.

BACKGROUND AND PURPOSE: Tissue hardness (induration), pain and tenderness are common late adverse effects of curative radiotherapy for early breast cancer. The purpose of this study was to test the efficacy of IH636 grape seed proanthocyanidin extract (GSPE) in patients with tissue induration after high-dose radiotherapy for early breast cancer in a double-blind placebo-controlled randomised phase II trial. PATIENTS AND METHODS: Sixty-six eligible research volunteers with moderate or marked breast induration at a mean 10.8 years since radiotherapy for early breast cancer were randomised to active drug (n = 44) or placebo (n = 22). All patients were given grape seed proanthocyanidin extract (GSPE) 100 mg three times a day orally, or corresponding placebo capsules, for 6 months. The primary endpoint was percentage change in surface area (cm(2)) of palpable breast induration measured at the skin surface 12 months after randomisation. Secondary endpoints included change in photographic breast appearance and patient self-assessment of breast hardness, pain and tenderness. RESULTS: At 12 months post-randomisation, > or =50% reduction in surface area (cm(2)) of breast induration was recorded in 13/44 (29.5%) GSPE and 6/22 (27%) placebo group patients (NS). At 12 months post-randomisation, there was no significant difference between treatment and control groups in terms of external assessments of tissue hardness, breast appearance or patient self-assessments of breast hardness, pain or tenderness. CONCLUSIONS: The study failed to show efficacy of orally-administered GSPE in patients with breast induration following radiotherapy for breast cancer.

Quality of life in the intergroup exemestane study: a randomized trial of exemestane versus continued tamoxifen after 2 to 3 years of tamoxifen in postmenopausal women with primary breast cancer.

PURPOSE: To compare and describe the quality of life (QOL) of women allocated to tamoxifen or exemestane within the Intergroup Exemestane Study (IES). PATIENTS AND METHODS: Postmenopausal women with primary breast cancer who were disease free after 2 to 3 years were randomly assigned to switch from tamoxifen to exemestane or continue with tamoxifen until 5 years of treatment were completed. A subset of IES centers participated in a QOL substudy. The Functional Assessment of Cancer Therapy-Breast (FACT-B) and endocrine subscale (ES) were administered before random assignment and at predefined follow-up times. The primary end point was the FACT-B composite Trial Outcome Index (TOI). Secondary end points included total FACT-B+ES score, total ES score, and severity of individual endocrine symptoms. This analysis reports QOL up to 24 months. RESULTS: Five hundred eighty-two patients from eight countries were enrolled onto the substudy. Completion and return of questionnaires was excellent, with 85% available for analysis. QOL was generally good and stable over 2 years, with no clinically meaningful differences found between groups in TOI or ES. Prevalence of severe endocrine symptoms at trial entry was high for vasomotor complaints and sexual problems, which persisted for both groups during the study. No significant differences between groups were seen for any endocrine symptoms apart from vaginal discharge, which was more pronounced with tamoxifen (P < .001). CONCLUSION: The switch from tamoxifen to exemestane neither increased nor decreased endocrine symptoms present after 2 to 3 years of tamoxifen; the switch also did not initiate significant reports of new symptoms. Results indicate that the clinical benefits of exemestane over tamoxifen are achieved without significant detrimental effect on QOL.