Long term impact of the WHI studies on information-seeking and decision-making in menopause symptoms management: a longitudinal analysis of questions to a medicines call centre

Abstract Background While women are taking a greater role in decisions about menopause symptom management, the legacy of the Women’s Health Initiative (WHI) studies persist. Despite hormone therapy (HT) being effective in reducing all-cause mortality, many women seeking relief of menopausal symptoms exaggerate HT harms and overstate the perceived benefits or ignore the risks of alternative therapies. We aimed to explore the longitudinal impact of the widely-publicised WHI 2002 study on women’s information-seeking and describe determinants of decision-making about managing menopausal symptoms. Methods In a longitudinal analysis of both quantitative and qualitative data, we explored consumer questions about menopause-related medicines received by two Australian medicines call centres (1996–2010) before, during, and after WHI 2002. We analysed calls by age and gender of caller and patient, their relationship, postcode, enquiry type, and motivation to help-seek. We compared calls regarding HT and herbal medicines (HM) with the rest of calls, and thematically analysed question narratives across the three time-periods. Results There were 1,829 menopause-related calls received of over this time-period, with a call surge, primarily from women in their mid-fifties, in the two months after the WHI 2002 publication. Two in three calls were motivated by negative media reports as women sought support for decision-making, primarily reassurance to cease HT. While HT safety concerns persisted for eight years post-publication, the nature of information-seeking changed over time. Callers subsequently sought reassurance to use menopause treatments together with their other medicines; and pursued HT substitutes, including HM, in response to HT product discontinuation. Conclusions Women sought information or reassurance to support a decision, based on dynamic changes in internal (symptom or risk intolerance, attitude towards menopause and treatment preferences) and external factors (perceived source trust and changes in treatment availability). In assessing HT benefit versus risk, women tend to overestimate risk with HT safety concerns persisting over time. Decision-making in managing menopause symptoms is complex and dynamic. Reassurance to reach or justify decisions from a perceived trusted source can support informed decision-making

The relationship between working alliance with peer mentors and eating psychopathology in a digital 6-week guided self-help intervention for anorexia nervosa

Objective: The quality of working alliance (WA) is associated with treatment outcomes across several types of psychiatric disorders and psychological interventions. This study examined the role of WA with peer mentors (people with lived experience of illness) and student mentors (graduated psychology students) in a 6-week, digital, guided self-help (GSH) intervention for anorexia nervosa. Method: Ninety-nine patients rated weekly, for 6 weeks: (a) eating psychopathology using the short version of the Eating Disorder Examination Questionnaire (EDE-QS) and (b) WA with a student mentor (n = 14) or a peer mentor (n = 10). WA was assessed by asking patients the extent to which they felt comfortable working with their mentor and the extent to which they agreed with them on the goals for support. WA with mentors and the association with eating psychopathology change were measured on a session-by-session basis. The analysis involved a random intercepts cross-lagged panel model. Results: WA with peer mentors was slightly higher than WA with students (ES = 0.3). Peer mentors' WA in the previous session was significantly associated with eating psychopathology ratings in the next session. No significant relationship was found between the previous session's EDE-QS scores and peer mentor alliance in the following session. In the student mentor group, there were no session-by-session associations between WA and eating psychopathology. However, greater WA with the student mentor across sessions was associated with less eating psychopathology. Discussion: These findings suggest that clinical outcomes are in part associated with the characteristics of the mentor delivering guidance in an online GSH for eating disorders

Enhanced motivational interviewing for reducing weight and increasing physical activity in adults with high cardiovascular risk: the MOVE IT three-arm RCT.

BACKGROUND: Motivational interviewing (MI) enhanced with behaviour change techniques (BCTs) and deployed by health trainers targeting multiple risk factors for cardiovascular disease (CVD) may be more effective than interventions targeting a single risk factor. OBJECTIVES: The clinical effectiveness and cost-effectiveness of an enhanced lifestyle motivational interviewing intervention for patients at high risk of CVD in group settings versus individual settings and usual care (UC) in reducing weight and increasing physical activity (PA) were tested. DESIGN: This was a three-arm, single-blind, parallel randomised controlled trial. SETTING: A total of 135 general practices across all 12 South London Clinical Commissioning Groups were recruited. PARTICIPANTS: A total of 1742 participants aged 40-74 years with a ≥ 20.0% risk of a CVD event in the following 10 years were randomised. INTERVENTIONS: The intervention was designed to integrate MI and cognitive-behavioural therapy (CBT), delivered by trained healthy lifestyle facilitators in 10 sessions over 1 year, in group or individual format. The control group received UC. RANDOMISATION: Simple randomisation was used with computer-generated randomisation blocks. In each block, 10 participants were randomised to the group, individual or UC arm in a 4 : 3 : 3 ratio. Researchers were blind to the allocation. MAIN OUTCOME MEASURES: The primary outcomes are change in weight (kg) from baseline and change in PA (average number of steps per day over 1 week) from baseline at the 24-month follow-up, with an interim follow-up at 12 months. An economic evaluation estimates the relative cost-effectiveness of each intervention. Secondary outcomes include changes in low-density lipoprotein cholesterol and CVD risk score. RESULTS: The mean age of participants was 69.75 years (standard deviation 4.11 years), 85.5% were male and 89.4% were white. At the 24-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA [mean 70.05 steps, 95% confidence interval (CI) -288 to 147.9 steps, and mean 7.24 steps, 95% CI -224.01 to 238.5 steps, respectively] or in reducing weight (mean -0.03 kg, 95% CI -0.49 to 0.44 kg, and mean -0.42 kg, 95% CI -0.93 to 0.09 kg, respectively). At the 12-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA (mean 131.1 steps, 95% CI -85.28 to 347.48 steps, and mean 210.22 steps, 95% CI -19.46 to 439.91 steps, respectively), but there were reductions in weight for the group and individual intervention arms compared with UC (mean -0.52 kg, 95% CI -0.90 to -0.13 kg, and mean -0.55 kg, 95% CI -0.95 to -0.14 kg, respectively). The group intervention arm was not more effective than the individual intervention arm in improving outcomes at either follow-up point. The group and individual interventions were not cost-effective. CONCLUSIONS: Enhanced MI, in group or individual formats, targeted at members of the general population with high CVD risk is not effective in reducing weight or increasing PA compared with UC. Future work should focus on ensuring objective evidence of high competency in BCTs, identifying those with modifiable factors for CVD risk and improving engagement of patients and primary care. TRIAL REGISTRATION: Current Controlled Trials ISRCTN84864870. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 69. See the NIHR Journals Library website for further project information. This research was part-funded by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London

Reducing weight and increasing physical activity in people at high risk of cardiovascular disease: a randomised controlled trial comparing the effectiveness of enhanced motivational interviewing intervention with usual care.

OBJECTIVE: The epidemic of obesity is contributing to the increasing prevalence of people at high risk of cardiovascular disease (CVD), negating the medical advances in reducing CVD mortality. We compared the clinical and cost-effectiveness of an intensive lifestyle intervention consisting of enhanced motivational interviewing in reducing weight and increasing physical activity for patients at high risk of CVD. METHODS: A three-arm, single-blind, parallel-group randomised controlled trial was conducted in consenting primary care centres in south London. We recruited patients aged 40-74 years with a QRisk2 score ≥20.0%, which indicates the probability of having a CVD event in the next 10 years. The intervention was enhanced motivational interviewing which included additional behaviour change techniques and was delivered by health trainers in 10 sessions over 1 year, in either group (n=697) or individual (n=523) format. The third arm received usual care (UC; n=522). The primary outcomes were physical activity (mean steps/day) and weight (kg). Secondary outcomes were changes in low-density lipoprotein cholesterol and CVD risk score. We estimated the relative cost-effectiveness of each intervention. RESULTS: At 24 months, the group and individual interventions were not more effective than UC in increasing physical activity (mean difference=70.05 steps, 95% CI -288.00 to 147.90 and mean difference=7.24 steps, 95% CI -224.01 to 238.50, respectively), reducing weight (mean difference=-0.03 kg, 95% CI -0.49 to 0.44 and mean difference=-0.42 kg, 95% CI -0.93 to 0.09, respectively) or improving any secondary outcomes. The group and individual interventions were not cost-effective at conventional thresholds. CONCLUSIONS: Enhancing motivational interviewing with additional behaviour change techniques was not effective in reducing weight or increasing physical activity in those at high CVD risk

The influence of the physical education teacher on intrinsic motivation, self-confidence, anxiety, and pre-and post-competition mood states

One of the fundamental problems facing teachers of physical education (PE) is how to increase pupils' motivation. From the point of view of goal achievement, guidelines need to be established so that information may be used to greater effect in classes. This study examined the relationship between the motivational climate created by the PE teacher and the intrinsic motivation of the preparatory sessions together with self-confidence and anxiety prior to competition and pre- and post-competition mood states. The sample was made up of school children (M age = 11.7) from a state school (N = 115), who, after an introduction to an athletics course of 12 sessions, took part in a sports competition. During this time, a teacher (trained to this effect) manipulated the motivational climate, adapting the strategies of TARGET (11, 12, 26, 28). The mastery climate was linked to enjoyment, perceived ability, and effort in the PE classes, as well as to pre-competition somatic anxiety and post-competition vigor. On the other hand, the performance climate was associated with self-confidence, pre-competition vigor, and post-competition stress. The results are discussed in relation to achievement goal theory and motivational climate manipulation

The archaeology of a landslide: Unravelling the Azores earthquake disaster of 1522 and its consequences

The multidisciplinary research described here shows how archaeologists can help reconstruct past seismic episodes and understand the subsequent relief operation, rehabilitation, and reconstruction processes. In October 1522, a major earthquake and landslide struck the then capital of the Azores, Vila Franca do Campo, 1500 km from the European mainland. Damage was extensive, destroying key monuments, affecting most of the inhabited area, and leaving few survivors among the early colonists. The results from twenty-six archaeological trenches, geological and geoarchaeological investigations, and documentary analysis are reviewed here. Distinctive archaeological deposits are identified and explained, using the high density of artefacts and the erosional contact between the landslide and the pre-1522 palaeosol to reconstruct the episode in detail

Response bias to a randomised controlled trial of a lifestyle intervention in people at high risk of cardiovascular disease: a cross-sectional analysis

Background Research evaluating lifestyle interventions for prevention of cardiovascular disease (CVD) may not reach those most at risk. We compared the response rate to a randomised controlled trial (RCT) of a lifestyle intervention by CVD risk, ethnicity and level of deprivation. Methods Primary care patients with a QRisk2 score ≥ 20% were invited to participate in a RCT of an intensive lifestyle intervention versus usual care. This cross-sectional analysis compares anonymised data of responders and non-responders with multiple logistic regression, using adjusted odds ratios (AORs) for QRisk2 score, ethnicity, Index of Multiple Deprivation (IMD 2010) quintile, age and sex. Results From 60 general practices, 8902 patients were invited and 1489 responded. The mean age was 67.3 years and 21.0% were female. Of all patients invited, 69.9% were of white ethnic background, 13.9% ethnic minority backgrounds and 16.2% had no ethnicity data recorded in their medical records. Likelihood of response decreased as QRisk2 score increased (AOR 0.82 per 5 percentage points, 95% CI 0.77–0.88). Black African or Caribbean patients (AOR 0.67; 95% CI 0.45–0.98) and those with missing ethnicity data (AOR 0.55; 95% CI 0.46–0.66) were less likely to respond compared to participants of white ethnicity, but there was no difference in the response rates between south Asian and white ethnicity (AOR 1.08; 95% CI 0.84–1.38). Patients residing in the fourth (AOR 0.70; 95% CI 0.56–0.87) and fifth (AOR 0.52; 95% CI 0.40–0.68) most deprived IMD quintile were less likely to respond compared to the least deprived quintile. Conclusions Evaluations of interventions intended for those at high risk of CVD may fail to reach those at highest risk. Hard to reach patient groups may require different recruitment strategies to maximise participation in future trials. Improvements in primary care ethnicity data recording is required to aid understanding of how successfully study samples represent the target population

Association between depressive symptoms and objectively measured daily step count in individuals at high risk of cardiovascular disease in South London, UK: a cross-sectional study.

OBJECTIVES: Depressive symptoms are common but rarely considered a risk factor for unhealthy lifestyles associated with cardiovascular disease (CVD). This study investigates whether depressive symptoms are associated with reduced physical activity (PA) in individuals at high risk of developing CVD. DESIGN: Secondary analysis of the cross-sectional baseline data from a randomised controlled trial of an intensive lifestyle intervention. SETTING: 135 primary care practices in South London, UK. PARTICIPANTS: 1742 adults, 49-74 years, 86% male at high (≥20%) risk of developing CVD in the next 10 years as defined via QRISK2 score. OUTCOME MEASURES: The main explanatory variable was depressive symptoms measured via the Patient Health Questionnaire-9 (PHQ-9). The main outcome was daily step count measured with an accelerometer (ActiGraph GT3X) stratified by weekdays and weekend days. RESULTS: The median daily step count of the total sample was 6151 (IQR 3510) with significant differences (P<0.001) in mean daily step count between participants with low (PHQ-9 score: 0-4), mild (PHQ-9 score: 5-9) and moderate to severe depressive symptoms (PHQ-9 score: ≥10). Controlling for age, gender, ethnicity, education level, body mass index (BMI), smoking, consumption of alcohol, day of the week and season, individuals with mild depressive symptoms and those with moderate to severe depressive symptoms walked 13.3% (95% CI 18.8% to 7.9%) and 15.6% (95% CI 23.7% to 6.5%) less than non-depressed individuals, respectively. Furthermore, male gender, white ethnicity, higher education level, lower BMI, non-smoking, moderate alcohol intake, weekdays and summer season were independently associated with higher step count. CONCLUSIONS: People at high risk of CVD with depressive symptoms have lower levels of PA. TRIAL REGISTRATION: ISRCTN84864870; Pre-results

Pulmonary metastasectomy versus continued active monitoring in colorectal cancer (PulMiCC): a multicentre randomised clinical trial

BACKGROUND: Lung metastasectomy in the treatment of advanced colorectal cancer has been widely adopted without good evidence of survival or palliative benefit. We aimed to test its effectiveness in a randomised controlled trial (RCT). METHODS: Multidisciplinary teams in 13 hospitals recruited participants with potentially resectable lung metastases to a multicentre, two-arm RCT comparing active monitoring with or without metastasectomy. Other local or systemic treatments were decided by the local team. Randomisation was remote and stratified by site with minimisation for age, sex, primary cancer stage, interval since primary resection, prior liver involvement, the number of metastases, and carcinoembryonic antigen level. The central Trial Management Group were blind to patient allocation until completion of the analysis. Analysis was on intention to treat with a margin for non-inferiority of 10%. RESULTS: Between December 2010 and December 2016, 65 participants were randomised. Characteristics were well-matched in the two arms and similar to those in reported studies: age 35 to 86 years (interquartile range (IQR) 60 to 74); primary resection IQR 16 to 35 months previously; stage at resection T1, 2 or 3 in 3, 8 and 46; N1 or N2 in 31 and 26; unknown in 8. Lung metastases 1 to 5 (median 2); 16/65 had previous liver metastases; carcinoembryonic antigen normal in 55/65. There were no other interventions in the first 6 months, no crossovers from control to treatment, and no treatment-related deaths or major adverse events. The Hazard ratio for death within 5 years, comparing metastasectomy with control, was 0.82 (95%CI 0.43, 1.56). CONCLUSIONS: Because of poor and worsening recruitment, the study was stopped. The small number of participants in the trial (N = 65) precludes a conclusive answer to the research question given the large overlap in the confidence intervals in the proportions still alive at all time points. A widely held belief is that the 5-year absolute survival benefit with metastasectomy is about 35%: 40% after metastasectomy compared to < 5% in controls. The estimated survival in this study was 38% (23-62%) for metastasectomy patients and 29% (16-52%) in the well-matched controls. That is the new and important finding of this RCT. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT01106261. Registered on 19 April 2010

A study of changes in genetic and environmental influences on weight and shape concern across adolescence

The goal of the current study was to examine whether genetic and environmental influences on an important risk factor for disordered eating, weight and shape concern (WSC), remained stable over adolescence. This stability was assessed in two ways: whether new sources of latent variance were introduced over development, and whether the magnitude of variance contributing to the risk factor changed. We examined an 8-item WSC sub-scale derived from the Eating Disorder Examination using telephone interviews with female adolescents. From three waves of data collected from female-female same sex twin pairs from the Australian Twin Registry, a subset of the data (which included 351 pairs at Wave 1) was used to examine three age cohorts: 12-13, 13-15, and 14-16 years. The best fitting model contained genetic and environmental influences, both shared and non-shared. Biometric model fitting indicated that non-shared environmental influences were largely specific to each age cohort, and results suggested that latent shared environmental and genetic influences that were influential at 12-13 years continued to contribute to subsequent age cohorts, with independent sources of both emerging at ages 13-15. The magnitude of all three latent influences could be constrained to be the same across adolescence. Ages 13-15 was indicated as a time of risk for the development of high levels of WSC given that most specific environmental risk factors were significant at this time (e.g., peer teasing about weight, adverse life events), and indications of the emergence of new sources of latent genetic and environmental variance over this period.NHMRC Grants 324715 and 480420