SISTAQUIT: training health care providers to help pregnant Aboriginal and Torres Strait Islander women quit smoking. A cluster randomised controlled trial.

BACKGROUND: About 44% of Indigenous Australian women smoke during pregnancy, compared with 12% of pregnant non-Indigenous women. Health care providers can assist smoking cessation, but they are not typically trained in culturally appropriate methods. OBJECTIVES: To determine whether a health care worker training intervention increases smoking cessation rates among Indigenous pregnant smokers compared with usual care. METHODS AND ANALYSIS: Supporting Indigenous Smokers to Assist Quitting (SISTAQUIT) study is a multicentre, hybrid type 1, pragmatic, cluster randomised controlled trial that compares the effects of an intervention for improving smoking cessation by pregnant Indigenous women (16 years or older, 32 weeks' gestation or less) with usual care. Twenty-one health services caring for Indigenous people in five Australian jurisdictions were randomised to the intervention (ten sites) or control groups (eleven sites). Health care providers at intervention sites received smoking cessation care training based on the ABCD (ask/assess; brief advice; cessation; discuss psychosocial context) approach to smoking cessation for Indigenous women, an educational resource package, free oral nicotine replacement therapy for participating women, implementation support, and trial implementation training. Health care providers in control group services provided usual care. PRIMARY OUTCOME: abstinence from smoking (self-reported abstinence via survey, validated by carbon monoxide breath testing when possible) four weeks after enrolment in the study. SECONDARY OUTCOMES: health service process evaluations; knowledge, attitudes, and practices of health care providers; and longer term abstinence, perinatal outcomes, and respiratory outcomes for babies (to six months). Ethics approval: The human research ethics committees of the University of Newcastle (H-2015-0438) and the Aboriginal Health and Medical Research Council of NSW (1140/15) provided the primary ethics approval. Dissemination of results: Findings will be disseminated in peer-reviewed publications, at local and overseas conferences, and via public and social media, and to participating health services in art-based formats and reports. Policy briefs will be communicated to relevant government organisations. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry, ACTRN12618000972224 (prospective).

Efficacy and Safety of Text Messages Targeting Adherence to Cardiovascular Medications in Secondary Prevention: TXT2HEART Colombia Randomized Controlled Trial.

BACKGROUND: Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality worldwide, with a prevalence of approximately 100 million patients. There is evidence that antiplatelet agents and antihypertensive medications could reduce the risk of new vascular events in this population; however, treatment adherence is very low. An SMS text messaging intervention was recently developed based on behavior change techniques to increase adherence to pharmacological treatment among patients with a history of ASCVD. OBJECTIVE: This study aims to evaluate the efficacy and safety of an SMS text messaging intervention to improve adherence to cardiovascular medications in patients with ASCVD. METHODS: A randomized controlled clinical trial for patients with a prior diagnosis of cardiovascular events, such as acute myocardial infarction, unstable angina, cerebrovascular disease, or peripheral artery disease, in one center in Colombia was conducted. Patients randomized to the intervention arm were assigned to receive SMS text messages daily for the first 4 weeks, 5 SMS text messages on week 5, 3 SMS text messages each in weeks 6 and 7, and 1 SMS text message weekly from week 8 until week 52. In contrast, patients in the control arm received a monthly SMS text message reminding them of the next study appointment and the importance of the study, requesting information about changes in their phone number, and thanking them for participating in the study. The primary endpoint was the change in low-density lipoprotein cholesterol (LDL-C) levels, whereas the secondary endpoints were the changes in thromboxane B2 levels, heart rate, systolic and diastolic blood pressure, medication adherence, cardiac and noncardiac mortality, and hospitalization. Linear regression analyses and bivariate tests were performed. RESULTS: Of the 930 randomized patients, 805 (86.5%) completed follow-up and were analyzed for the primary endpoint. There was no evidence that the intervention changed the primary outcome (LDL-C levels; P=.41) or any of the secondary outcomes evaluated (all P>.05). There was also no evidence that the intervention was associated with adverse events. CONCLUSIONS: In this study, there was no evidence that a behavior modification intervention delivered by SMS text messaging improved LDL-C levels, blood pressure levels, or adherence at 12 months. More research is needed to evaluate whether different SMS text messaging strategies, including personalized messages and different timings, are effective; future studies should include mixed methods to better understand why, for whom, and in which context (eg, health system or social environment) SMS text messaging interventions work (or not) to improve adherence in patients with ASCVD. TRIAL REGISTRATION: ClinicalTrials.gov NCT03098186; https://clinicaltrials.gov/ct2/show/NCT03098186. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2018-028017.

Optimising antimicrobial stewardship interventions in English primary care: a behavioural analysis of qualitative and intervention studies.

OBJECTIVE: While various interventions have helped reduce antibiotic prescribing, further gains can be made. This study aimed to identify ways to optimise antimicrobial stewardship (AMS) interventions by assessing the extent to which important influences on antibiotic prescribing are addressed (or not) by behavioural content of AMS interventions. SETTINGS: English primary care. INTERVENTIONS: AMS interventions targeting healthcare professionals' antibiotic prescribing for respiratory tract infections. METHODS: We conducted two rapid reviews. The first included qualitative studies with healthcare professionals on self-reported influences on antibiotic prescribing. The influences were inductively coded and categorised using the Theoretical Domains Framework (TDF). Prespecified criteria were used to identify key TDF domains. The second review included studies of AMS interventions. Data on effectiveness were extracted. Components of effective interventions were extracted and coded using the TDF, Behaviour Change Wheel and Behaviour Change Techniques (BCTs) taxonomy. Using prespecified matrices, we assessed the extent to which BCTs and intervention functions addressed the key TDF domains of influences on prescribing. RESULTS: We identified 13 qualitative studies, 41 types of influences on antibiotic prescribing and 6 key TDF domains of influences: 'beliefs about consequences', 'social influences', 'skills', 'environmental context and resources', 'intentions' and 'emotions'. We identified 17 research-tested AMS interventions; nine of them effective and four nationally implemented. Interventions addressed all six key TDF domains of influences. Four of these six key TDF domains were addressed by 50%-67% BCTs that were theoretically congruent with these domains, whereas TDF domain 'skills' was addressed by 24% of congruent BCTs and 'emotions' by none. CONCLUSIONS: Further improvement of antibiotic prescribing could be facilitated by: (1) national implementation of effective research-tested AMS interventions (eg, electronic decision support tools, training in interactive use of leaflets, point-of-care testing); (2) targeting important, less-addressed TDF domains (eg, 'skills', 'emotions'); (3) using relevant, under-used BCTs to target key TDF domains (eg, 'forming/reversing habits', 'reducing negative emotions', 'social support'). These could be incorporated into existing, or developed as new, AMS interventions.

Fit to Perform: A Profile of Higher Education Music Students' Physical Fitness.

The physical demands of music making are well acknowledged, but understanding of musicians' physical and fitness profiles is nonetheless limited, especially those of advanced music students who are training to enter music's competitive professional landscape. To gain insight into how physical fitness is associated with music making, this study investigated music students' fitness levels on several standardized indicators. Four hundred and eighty three students took part in a fitness screening protocol that included measurements of lung function, flexibility (hypermobility, shoulder range of motion, sit and reach), strength and endurance (hand grip, plank, press-up), and sub-maximal cardiovascular fitness (3-min step test), as well as self-reported physical activity (IPAQ-SF). Participants scored within age-appropriate ranges on lung function, shoulder range of motion, grip strength, and cardiovascular fitness. Their results for the plank, press-up, and sit and reach were poor by comparison. Reported difficulty (22%) and pain (17%) in internal rotation of the right shoulder were also found. Differences between instrument groups and levels of study were observed on some measures. In particular, brass players showed greater lung function and grip strength compared with other groups, and postgraduate students on the whole were able to maintain the plank for longer but also demonstrated higher hypermobility and lower lung function and cardiovascular fitness than undergraduate students. Seventy-nine percent of participants exceeded the minimum recommended weekly amount of physical activity, but this was mostly based on walking activities. Singers were the most physically active group, and keyboard players, composers, and conductors were the least active. IPAQ-SF scores correlated positively with lung function, sit and reach, press-up and cardiovascular fitness suggesting that, in the absence of time and resources to carry out comprehensive physical assessments, this one measure alone can provide useful insight into musicians' fitness. The findings show moderate levels of general health-related fitness, and we discuss whether moderate fitness is enough for people undertaking physically and mentally demanding music making. We argue that musicians could benefit from strengthening their supportive musculature and enhancing their awareness of strength imbalances.

Evaluation of the efficacy and safety of text messages targeting adherence to cardiovascular medications in secondary prevention: the txt2heart Colombia randomised controlled trial protocol.

INTRODUCTION: Anti-platelet therapy, angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, beta-blockers and statins are cost-effective in patients with atherosclerotic cardiovascular diseases (ASCVD) for reducing the risk of ASCVD events. Unfortunately, there is abundant evidence that adherence to these cardiovascular medications is far from ideal. A recent Cochrane review showed a potential beneficial effect of Short Message Service (SMS) interventions on adherence to medication in ASCVD patients. METHODS AND ANALYSIS: The txt2heart study is a pragmatic randomised single-blind controlled trial. The objective is to evaluate the efficacy and safety of an intervention with SMS messages delivered by mobile phones to improve adherence to cardiovascular medications in patients with ASCVD. The intervention consists of behavioural techniques delivered via SMS. The primary outcome is change in blood serum low-density lipoprotein cholesterol levels as an indicator of adherence to statins. Secondary outcomes will include systolic blood pressure as an indicator of adherence to blood-lowering therapies and heart rate as an indicator of adherence to beta-blockers, urine levels of 11-dehydrothromboxane B2, self-reported adherence to cardiovascular medications and rates of cardiovascular death or hospitalisation due to cardiovascular disease. ETHICS AND DISSEMINATION: The study will be performed in compliance with the protocol, regulatory requirements, Good Clinical Practice and ethical principles of the Declaration of Helsinki. The Ethics Committee of Fundación Cardiovascular de Colombia evaluated and approved the trial. The txt2heart Colombia trial aims to provide robust evidence to evaluate whether SMS messages delivered through mobile telephones change the behaviour of Colombian patients who have suffered a cardiovascular event. Trial results will be presented to the local health authorities, and if the intervention is effective and safe, we hope this strategy will be implemented quickly because of its low cost and wide-reaching impact on the population. TRIAL REGISTRATION NUMBER: NCT03098186.

Improving smoking cessation care in pregnancy at Aboriginal Medical Services: 'ICAN QUIT in Pregnancy' step-wedge cluster randomised study.

OBJECTIVES: This study aimed to examine the impact of the 'ICAN QUIT in Pregnancy' intervention on individual health providers (HPs) smoking cessation care (SCC) knowledge, attitudes and practices in general, and specifically regarding nicotine replacement therapy (NRT) prescription. DESIGN: Step-wedge clustered randomised controlled study. HPs answered a preintervention and 1-6 months postintervention survey. SETTING: Six Aboriginal Medical Services (AMSs) in three states of Australia. PARTICIPANTS: All HPs were invited to participate. Of 93 eligible, 50 consented (54%), 45 completed the presurvey (90%) and 20 the post (40%). INTERVENTION: Included three 1-hour webinar sessions, educational resource package and free oral NRT. OUTCOMES: HPs knowledge was measured using two composite scores-one from all 24 true/false statements, and one from 12 NRT-specific statements. Self-assessment of 22 attitudes to providing SCC were measured using a five-point Likert scale (Strongly disagree to Strongly agree). Two composite mean scores were calculated-one for 15 general SCC attitudes, and one for 7 NRT-specific attitudes. Self-reported provision of SCC components was measured on a five-point Likert scale (Never to Always). Feasibility outcomes, and data collected on the service and patient level are reported elsewhere. RESULTS: Mean knowledge composite scores improved from pre to post (78% vs 84% correct, difference 5.95, 95% CI 1.57 to 10.32). Mean NRT-specific knowledge composite score also improved (68% vs 79% correct, difference 9.9, 95% CI 3.66 to 16.14). Mean attitude composite score improved (3.65 (SD 0.4) to 3.87 (SD 0.4), difference 0.23, 95% CI 0.05 to 0.41). Mean NRT-specific attitudes composite score also improved (3.37 (SD 0.6) to 3.64 (SD 0.7), difference 0.36, 95% CI 0.13 to 0.6). Self-reported practices were unchanged, including prescribing NRT. CONCLUSIONS: A multicomponent culturally sensitive intervention in AMSs was feasible, and might improve HPs provision of SCC to pregnant Aboriginal women. Changes in NRT prescription rates may require additional intensive measures. TRIAL REGISTRATION NUMBER: ACTRN 12616001603404; Results.

Enhancing self-care adherence in patients with heart failure: a study protocol for developing a theory-based behaviour change intervention using the COM-B behaviour model (ACHIEVE study).

INTRODUCTION: Although international guidelines recommend self-care as an integral part of routine heart failure management, and despite evidence supporting the positive outcomes related to self-care, patients are frequently unable to adhere. Self-care can be modified through behaviour change interventions (BCIs). However, previous self-care interventions have shown limited success in improving adherence to self-care, because they were neither theory-based nor well defined, which precludes the identification of underlying causal mechanisms as well as reproducibility of the intervention. Thus, our aim is to develop an intervention manual that contains theory-based BCIs that are well-defined using eight descriptors proposed to describe BCIs in a standardised way. METHODS AND ANALYSIS: BCIs will be based on statements of findings derived through qualitative meta-summary techniques and a quantitative meta-analysis. These reviews will be used to extract factors (target behaviours) associated with self-care adherence/non-adherence. Extracted target behaviours will be mapped onto the 'Capability, Opportunity, Motivation and Behaviour' (COM-B) model to capture the underlying mechanisms involved. To develop approaches for change, the 'Taxonomy of Behaviour Change Techniques' will be used to allow effective mapping of the target behaviours onto established behaviour change techniques. Suggested BCIs will then be translated into locally relevant interventions using the Normalisation Process Theory to overcome the difficulties of implementing theoretically derived interventions into practice. Finally, a consensus development method will be employed to fine-tune the content and acceptability of the intervention manual to increase the likelihood of successfully piloting and implementing future BCIs into the German healthcare system. ETHICS AND DISSEMINATION: This study has been reviewed and approved by the Ethics Committee of the Medical Faculty of the Heinrich Heine University Düsseldorf, Germany (Ref #: 2018-30). The results will be disseminated via peer-reviewed journal publications, conference presentations and stakeholder engagement activities. TRIAL REGISTRATION NUMBER: DRKS00014855; Pre-results.

Promoting well-being through group drumming with mental health service users and their carers.

PURPOSE: Music has been linked with well-being across clinical and community settings. Yet, research has focused on assessment of single dimensions of well-being and on the typical receiver of support services. Acknowledging the burden that a caring role encompasses and integrating recent proposals for a multifaceted definition of well-being, we explore the extent to which group drumming interventions translate into multidimensional well-being change for both mental health service users and carers. METHOD: Thirty-nine participants engaged in one of a series of community drumming programmes were assessed via semi-structured interviews (n = 11) and focus groups (n = 28) at the end of each programme. Data were analysed using IPA. RESULTS AND CONCLUSION: Emotional, psychological and social dimensions of well-being emerged for both patients and carers, accounted for through six themes: (1) hedonia: positive affect and pleasant physical effects of drumming; (2) agency: initiative and sense of control; (3) accomplishment: non-specific and in relation to musical goals; (4) engagement, through focus and flow; (5) a redefinition of self, through self-awareness, construction of a positive identity, self-prospection and incorporation of a musical identity; and (6) social well-being, through connectedness and positive relationships. The potential of such interventions for clinical contexts is discussed.

Fit to Perform: An Investigation of Higher Education Music Students' Perceptions, Attitudes, and Behaviors toward Health.

Making music at the highest international standards can be rewarding, but it is also challenging, with research highlighting pernicious ways in which practicing and performing can affect performers' health and wellbeing. Several studies indicate that music students' perceptions, attitudes, and behaviors toward health and healthy living are less than optimal, especially considering the multiple physical and psychological demands of their day-to-day work. This article presents the results of a comprehensive screening protocol that investigated lifestyle and health-related attitudes and behaviors among 483 undergraduate and postgraduate students (mean age = 21.29 years ± 3.64; 59% women) from ten conservatoires. The protocol included questionnaires measuring wellbeing, general health, health-promoting behaviors, perfectionism, coping, sleep quality, and fatigue. On each measure, the data were compared with existing published data from similar age groups. The results indicate that music students have higher levels of wellbeing and lower fatigue than comparable samples outside of music. However, they also reveal potentially harmful perceptions, attitudes, and behaviors toward health. Specifically, engagement in health responsibility and stress management was low, which along with high perfectionistic strivings, limited use of coping strategies, poor sleep quality, and low self-rated health, paints a troubling picture both for the music students and for those who support their training. The findings point to the need for more (and more effective) health education and promotion initiatives within music education; in particular, musicians should be better equipped with mental skills to cope with constant pressure to excel and high stress levels. In part, this calls for musicians themselves to engage in healthier lifestyles, take greater responsibility for their own health, and be aware of and act upon health information in order to achieve and sustain successful practice and performance. For that to happen, however, music educators, administrators, and policy makers must play an active role in providing supportive environments where health and wellbeing is considered integral to expert music training.

Big hearts, small hands: a focus group study exploring parental food portion behaviours.

BACKGROUND: The development of healthy food portion sizes among families is deemed critical to childhood weight management; yet little is known about the interacting factors influencing parents' portion control behaviours. This study aimed to use two synergistic theoretical models of behaviour: the COM-B model (Capability, Opportunity, Motivation - Behaviour) and Theoretical Domains Framework (TDF) to identify a broad spectrum of theoretically derived influences on parents' portion control behaviours including examination of affective and habitual influences often excluded from prevailing theories of behaviour change. METHODS: Six focus groups exploring family weight management comprised of one with caseworkers (n = 4), four with parents of overweight children (n = 14) and one with parents of healthy weight children (n = 8). A thematic analysis was performed across the dataset where the TDF/COM-B were used as coding frameworks. RESULTS: To achieve the target behaviour, the behavioural analysis revealed the need for eliciting change in all three COM-B domains and nine associated TDF domains. Findings suggest parents' internal processes such as their emotional responses, habits and beliefs, along with social influences from partners and grandparents, and environmental influences relating to items such as household objects, interact to influence portion size behaviours within the home environment. CONCLUSION: This is the first study underpinned by COM-B/TDF frameworks applied to childhood weight management and provides new targets for intervention development and the opportunity for future research to explore the mediating and moderating effects of these variables on one another.

Implementation evaluation and refinement of an intervention to improve blunt chest injury management-A mixed-methods study.

AIMS AND OBJECTIVES: To investigate uptake of a Chest Injury Protocol (ChIP), examine factors influencing its implementation and identify interventions for promoting its use. BACKGROUND: Failure to treat blunt chest injuries in a timely manner with sufficient analgesia, physiotherapy and respiratory support, can lead to complications such as pneumonia and respiratory failure and/or death. DESIGN: This is a mixed-methods implementation evaluation study. METHODS: Two methods were used: (i) identification and review of the characteristics of all patients eligible for the ChIP protocol, and (ii) survey of hospital staff opinions mapped to the Theoretical Domains Framework (TDF) to identify barriers and facilitators to implementation. The characteristics and treatment received between the groups were compared using the chi-square test or Fischer's exact test for proportions, and the Mann-Whitney U-test for continuous data. Quantitative survey data were analysed using descriptive statistics. Qualitative data were coded in NVivo 10 using a coding guide based on the TDF and Behaviour Change Wheel (BCW). Identification of interventions to change target behaviours was sourced from the Behaviour Change Technique Taxonomy Version 1 in consultation with stakeholders. RESULTS: Only 68.4% of eligible patients received ChIP. Fifteen facilitators and 10 barriers were identified to influence the implementation of ChIP in the clinical setting. These themes were mapped to 10 of the 14 TDF domains and corresponded with all nine intervention functions in the BCW. Seven of these intervention functions were selected to address the target behaviours and a multi-faceted relaunch of the revised protocol developed. Following re-launch, uptake increased to 91%. CONCLUSIONS: This study demonstrated how the BCW may be used to revise and improve a clinical protocol in the ED context. RELEVANCE TO CLINICAL PRACTICE: Newly implemented clinical protocols should incorporate clinician behaviour change assessment, strategy and interventions. Enhancing the self-efficacy of emergency nurses when performing assessments has the potential to improve patient outcomes and should be included in implementation strategy.

Making music for mental health: how group drumming mediates recovery.

BACKGROUND: While music-making interventions are increasingly recognised as enhancing mental health, little is known of why music may engender such benefit. The objective of this article is to elucidate the features of a programme of group drumming known to enable mental health recovery. METHODS: Qualitative research was conducted with 39 mental health patients and carers who had demonstrated recovery following engagement with a programme of group djembe drumming in the UK. Data were collected through semi-structured individual interviews and focus group interviews designed to understand the connection between drumming and recovery and analysed using Interpretative Phenomenological Analysis (IPA). RESULTS: Results revealed three overarching features of the drumming intervention: (1) the specific features of drumming, including drumming as a form of non-verbal communication, as a connection with life through rhythm, and as a grounding experience that both generates and liberates energy; (2) the specific features of the group, including the group as a space of connection in and through the rhythmic features of the drumming, as well as facilitating feelings of belonging, acceptance, safety and care, and new social interactions; (3) the specific features of the learning, including learning as an inclusive activity in which the concept of mistakes is dissolved and in which there is musical freedom, supported by an embodied learning process expedited by the musical facilitator. CONCLUSION: The findings provide support for the conceptual notion of 'creative practice as mutual recovery', demonstrating that group drumming provides a creative and mutual learning space in which mental health recovery can take place.

Factors influencing variation in physician adenoma detection rates: a theory-based approach for performance improvement.

BACKGROUND AND AIMS: Interventions to improve physician adenoma detection rates for colonoscopy have generally not been successful, and there are little data on the factors contributing to variation that may be appropriate targets for intervention. We sought to identify factors that may influence variation in detection rates by using theory-based tools for understanding behavior. METHODS: We separately studied gastroenterologists and endoscopy nurses at 3 Kaiser Permanente Northern California medical centers to identify potentially modifiable factors relevant to physician adenoma detection rate variability by using structured group interviews (focus groups) and theory-based tools for understanding behavior and eliciting behavior change: the Capability, Opportunity, and Motivation behavior model; the Theoretical Domains Framework; and the Behavior Change Wheel. RESULTS: Nine factors potentially associated with adenoma detection rate variability were identified, including 6 related to capability (uncertainty about which types of polyps to remove, style of endoscopy team leadership, compromised ability to focus during an examination due to distractions, examination technique during withdrawal, difficulty detecting certain types of adenomas, and examiner fatigue and pain), 2 related to opportunity (perceived pressure due to the number of examinations expected per shift and social pressure to finish examinations before scheduled breaks or the end of a shift), and 1 related to motivation (valuing a meticulous examination as the top priority). Examples of potential intervention strategies are provided. CONCLUSIONS: By using theory-based tools, this study identified several novel and potentially modifiable factors relating to capability, opportunity, and motivation that may contribute to adenoma detection rate variability and be appropriate targets for future intervention trials.

Does patient education work in breast cancer? Final results from the global CARIATIDE study.

AIM: To determine the impact of educational materials (EMs) on the treatment compliance of postmenopausal women with hormone receptor-positive (HR+) early-stage breast cancer. PATIENTS & METHODS: Patients (n = 2757) were randomized to standard aromatase inhibitors (AI) alone (group A) or with EMs (group B) in a global, real-world setting. RESULTS: The 2-year results (n = 2242) showed EMs had no impact on compliance (82 vs. 82%, group A vs. B), compliance with initial AI (82 vs. 81%) or persistence (90 vs. 88%), confirming the 1-year interim analysis (n = 2567). Of the 2082 patients considered compliant at 1 year, 77% remained compliant at 2 years. Discontinuations (9%) were mainly attributed to AI-related side effects (68% of discontinuations). Exploratory analyses suggest a relationship between patient characteristics and compliance behaviors. CONCLUSION: EMs do not improve compliance in this patient population. Compliance and persistence are complex end points influenced by multiple variables. Side effects were the main reasons for discontinuations.

The impact of educational materials on compliance and persistence rates with adjuvant aromatase inhibitor treatment: first-year results from the compliance of aromatase inhibitors assessment in daily practice through educational approach (CARIATIDE) study.

The CARIATIDE study was designed to assess the impact of educational materials (EMs) on compliance and persistence rates with aromatase inhibitor (AI) treatment in postmenopausal women with hormone-receptor-positive early breast cancer. Patients were randomized to standard AI treatment (Group A; N = 1379) or standard AI treatment plus EMs containing information on a range of breast-cancer-related topics (Group B; N = 1379). Standardized questionnaires assessed investigator-perceived levels of care and evaluated patient compliance and behavior. At 1 year, there was no significant difference in compliance between Group A and Group B (81% vs. 82%, p = 0.4524). However, higher compliance in patients receiving EMs was observed in Sweden/Finland (p = 0.0246). Compliance with initial AI and persistence rate were not significantly altered by EM. Other factors associated with improved compliance, irrespective of EMs, e.g. administration of chemotherapy were identified.

Measuring the quality of MDT working: an observational approach.

BACKGROUND: Cancer multidisciplinary teams (MDTs) are established in many countries but little is known about how well they function. A core activity is regular MDT meetings (MDMs) where treatment recommendations are agreed. A mixed methods descriptive study was conducted to develop and test quality criteria for observational assessment of MDM performance calibrated against consensus from over 2000 MDT members about the "characteristics of an effective MDT". METHODS: Eighteen of the 86 'Characteristics of Effective MDTs' were considered relevant and feasible to observe. They collated to 15 aspects of MDT working covering four domains: the team (e.g. attendance, chairing, teamworking); infrastructure for meetings (venue, equipment); meeting organisation and logistics; and patient-centred clinical decision-making (patient-centredness, clarity of recommendations). Criteria for rating each characteristic from 'very poor' to 'very good' were derived from literature review, observing MDMs and expert input. Criteria were applied to 10 bowel cancer MDTs to assess acceptability and measure variation between and within teams. Feasibility and inter-rater reliability was assessed by comparing three observers. RESULTS: Observational assessment was acceptable to teams and feasible to implement. Total scores from 29 to 50 (out of 58) highlighted wide diversity in quality between teams. Eight teams were rated either 'very good/good' or 'very poor/poor' for at least three domains demonstrating some internal consistency. 'Very good' ratings were most likely for attendance and administrative preparation, and least likely for patient-centredness of decision-making and prioritisation of complex cases. All except two characteristics had intra-class correlations of ≥0.50. CONCLUSIONS: This observational tool (MDT-OARS) may contribute to the assessment of MDT performance. Further testing to confirm validity and reliability is required.

Marital relationships in amyotrophic lateral sclerosis.

Our objective was to determine change over time in quality of marital relationships of people with ALS (pwALS). Fifty pwALS and their spouse carers completed measures of marital intimacy, pwALS's functional status, their own psychological status, and beliefs about the pwALS's illness. Twenty-seven dyads completed two further assessments, at six-monthly intervals. Post-ALS diagnosis ratings of current marital relationship did not change over time for pwALS or their spouses. However, spouse carers' ratings of their current marital relationship were lower than their ratings prior to illness onset. After adjusting for the pre-illness marital relationship, pwALSs' current ratings of their marital relationship were initially predicted by their self-rated psychosocial functional impairment and satisfaction with their personal relationships, and subsequently by levels of self-esteem. After adjusting for ratings of the pre-illness marital relationship, carers' current marital intimacy scores at first and second interview were predicted by ratings of the patients' psychosocial functional impairment and by feelings of burden at the third interview. In conclusion, quality of the pre-illness marital relationship is a significant predictor of ongoing marital relationship in both pwALS and their spouse carers. Additionally, social and psychological rather than disease symptoms are important predictors of marital relationship quality after ALS diagnosis.

Effects of anastrozole on cognitive performance in postmenopausal women: a randomised, double-blind chemoprevention trial (IBIS II).

BACKGROUND: Mild cognitive impairments have been recorded in cross-sectional studies of women with breast cancer receiving endocrine treatment. More comprehensive studies were warranted because aromatase inhibitors are being used increasingly in both chemoprevention and adjuvant settings. We report findings from the cognitive subprotocol of the International Breast Intervention Study (IBIS II), a double-blind placebo-controlled trial of anastrozole in postmenopausal women at high risk of developing breast cancer. We aimed to study and compare the effect of anastrozole versus placebo on memory and attention in these women. METHODS: Between Jan 3, 2003, and Dec 21, 2005, participants were recruited into the cognitive subprotocol from five UK centres. Cognitive assessments were done before randomisation, at 6 months, and at 24 months. 227 of 249 women approached completed a comprehensive set of standardised cognitive tasks at baseline and were randomly assigned to receive anastrozole (1 mg/day for 5 years) or placebo. Psychological morbidity, endocrine symptoms, and self-reported cognitive complaints were also measured. The main outcomes were cognitive task scores at baseline, 6 months, and 24 months. Analyses were done by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN31488319. FINDINGS: 111 women were assigned to anastrozole and 116 women to placebo. At 6 months, ten women in each group were excluded from analysis, leaving a total of 207 of 227 (91%) women available for further assessments. At 24 months, 24 women were excluded from the anastrozole group and 32 from the placebo group, leaving 151 of 227 (67%) women. We did not note any significant differences between the groups for any of the cognitive tasks. By 6 months, 13 women in both groups reported changes to their memory and this had decreased to five women in the placebo group and three women in the anastrozole group by the 24-month assessment. Significantly more women in the anastrozole group complained of hot flushes at 24 months (23 of 76 [30%] vs 11 of 73 [15%], p=0.032, not corrected for multiple comparison), but this was the only difference in reported endocrine symptoms. INTERPRETATION: These findings show little or no impairment of cognitive performance with the use of anastrozole compared with placebo in postmenopausal women at high risk of developing breast cancer who were able to tolerate endocrine-related side-effects. Future studies assessing cognition should be done within randomised trials with baseline assessments to ascertain the true extent of the putative effects that treatments for breast cancer might have on memory and attention. FUNDING: Cancer Research UK, London, UK (grant numbers C6280/A3162 and C6280/A6764).

Fallowfield's Sexual Activity Questionnaire in women with without and at risk of cancer.

OBJECTIVES: To determine the effect of cancer, cancer risk, menopausal status and psychological factors on sexual activity as measured by Fallowfield's Sexual Activity Questionnaire (FSAQ). STUDY DESIGN AND MAIN OUTCOME MEASURES: Five groups of women completed the FSAQ: 1451 healthy women who were participating in an ovarian cancer screening trial; 488 healthy women at increased risk of breast cancer who were participating in a chemoprevention trial; 154 healthy women at increased risk of breast cancer who had been offered risk-reducing surgery; 117 women with advanced ovarian cancer; and a healthy non-study sample of 162 women. RESULTS: There were significant between-group differences regarding age (F=1373.79, P<0.01) and the proportion of women who were sexually active (chi2(4)=212.62, P<0.01) (more younger women reported being sexually active). The most commonly cited reason for sexual inactivity was the absence of a partner. In relation to their sexual activity, women with ovarian cancer reported less pleasure (F=18.27, P<0.01), more discomfort (F=21.33, P<0.01) and less frequency (F=200.01, P<0.01) than the other groups. Premenopausal women reported more pleasure (t=4.41, P<0.01), less discomfort (t=11.79, P<0.01) and greater frequency of sexual activity (t=8.58, P<0.01) than postmenopausal women. Psychological morbidity was associated with decreased pleasure in sexual activity among the women with an elevated risk of cancer - that is, those participating in the chemoprevention trial (t=4.20, P<0.01) and those offered risk-reducing surgery (t=3.32, P<0.01). CONCLUSIONS: The FSAQ is a useful tool for measuring sexual activity in women with cancer and women at a normal or increased risk of developing cancer. Age, cancer, psychological distress and menopausal status affect sexual activity in these groups of women and should be considered in future investigations.