Bridging the age gap in breast cancer: impact of omission of breast cancer surgery in older women with oestrogen receptor-positive early breast cancer on quality-of-life outcomes.

BACKGROUND: Primary endocrine therapy may be an alternative treatment for less fit women with oestrogen receptor (ER)-positive breast cancer. This study compared quality-of-life (QoL) outcomes in older women treated with surgery or primary endocrine therapy. METHODS: This was a multicentre, prospective, observational cohort study of surgery or primary endocrine therapy in women aged over 70 years with operable breast cancer. QoL was assessed using European Organisation for Research and Treatment of cancer QoL questionnaires QLQ-C30, -BR23, and -ELD14, and the EuroQol Five Dimensions 5L score at baseline, 6 weeks, and 6, 12, 18, and 24 months. Propensity score matching was used to adjust for baseline variation in health, fitness, and tumour stage. RESULTS: The study recruited 3416 women (median age 77 (range 69-102) years) from 56 breast units. Of these, 2979 (87.2 per cent) had ER-positive breast cancer; 2354 women had surgery and 500 received primary endocrine therapy (125 were excluded from analysis due to inadequate data or non-standard therapy). Median follow-up was 52 months. The primary endocrine therapy group was older and less fit. Baseline QoL differed between the groups; the mean(s.d.) QLQ-C30 global health status score was 66.2(21.1) in patients who received primary endocrine therapy versus 77.1(17.8) among those who had surgery plus endocrine therapy. In the unmatched analysis, changes in QoL between 6 weeks and baseline were noted in several domains, but by 24 months most scores had returned to baseline levels. In the matched analysis, major surgery (mastectomy or axillary clearance) had a more pronounced adverse impact than primary endocrine therapy in several domains. CONCLUSION: Adverse effects on QoL are seen in the first few months after surgery, but by 24 months these have largely resolved. Women considering surgery should be informed of these effects.

Bridging the age gap in breast cancer: cluster randomized trial of two decision support interventions for older women with operable breast cancer on quality of life, survival, decision quality, and treatment choices.

BACKGROUND: Rates of surgery and adjuvant therapy for breast cancer vary widely between breast units. This may contribute to differences in survival. This cluster RCT evaluated the impact of decision support interventions (DESIs) for older women with breast cancer, to ascertain whether DESIs influenced quality of life, survival, decision quality, and treatment choice. METHODS: A multicentre cluster RCT compared the use of two DESIs against usual care in treatment decision-making in older women (aged at least ≥70 years) with breast cancer. Each DESI comprised an online algorithm, booklet, and brief decision aid to inform choices between surgery plus adjuvant endocrine therapy versus primary endocrine therapy, and adjuvant chemotherapy versus no chemotherapy. The primary outcome was quality of life. Secondary outcomes included decision quality measures, survival, and treatment choice. RESULTS: A total of 46 breast units were randomized (21 intervention, 25 usual care), recruiting 1339 women (670 intervention, 669 usual care). There was no significant difference in global quality of life at 6 months after the baseline assessment on intention-to-treat analysis (difference -0.20, 95 per cent confidence interval (C.I.) -2.69 to 2.29; P = 0.900). In women offered a choice of primary endocrine therapy versus surgery plus endocrine therapy, knowledge about treatments was greater in the intervention arm (94 versus 74 per cent; P = 0.003). Treatment choice was altered, with a primary endocrine therapy rate among women with oestrogen receptor-positive disease of 21.0 per cent in the intervention versus 15.4 per cent in usual-care sites (difference 5.5 (95 per cent C.I. 1.1 to 10.0) per cent; P = 0.029). The chemotherapy rate was 10.3 per cent at intervention versus 14.8 per cent at usual-care sites (difference -4.5 (C.I. -8.0 to 0) per cent; P = 0.013). Survival was similar in both arms. CONCLUSION: The use of DESIs in older women increases knowledge of breast cancer treatment options, facilitates shared decision-making, and alters treatment selection. Trial registration numbers: EudraCT 2015-004220-61 (https://eudract.ema.europa.eu/), ISRCTN46099296 (http://www.controlled-trials.com).

Potential sources of mouth drying in beverages fortified with dairy proteins: A comparison of casein- and whey-rich ingredients.

Oral nutritional supplement drinks (ONS) are beverages high in dairy proteins that are prescribed to individuals at risk of malnutrition. Consumption of ONS is poor in elderly care facilities, with patients commenting that the sensory attributes of these drinks reduce their enjoyment and willingness to consume. Mouth drying is an attribute of ONS found to build with repeated consumption, which may further limit liking of these products. This study investigated the sources of drying sensations by sequential profiling, with a trained sensory panel rating a range of model milk systems and ONS over repeated sips and during after-effects. Sequential profiling found that fortification of milk with both caseinate and whey protein concentrate significantly increased the perception of mouth drying over repeated consumption, increasing by between 35 and 85% over consumption of 40mL. Enrichment of ONS with either whey protein concentrate or milk protein concentrate to a total protein content of 8.7% (wt/wt) resulted in whey and casein levels of 4.3:4.4% and 1.7:7.0% respectively. The product higher in whey protein was substantially more mouth drying, implying that whey proteins may be the most important contributor to mouth drying in ONS. However, efforts to mask mouth drying of protein-fortified milk by increasing sweetness or fat level were unsuccessful at the levels tested. Increasing the viscosity of protein-fortified milk led to a small but significant reduction in mouth drying. However, this approach was not successful when tested within complete ONS. Further analysis is required into the mechanism of protein-derived mouth drying to mask negative sensations and improve the enjoyment and consumption of protein-rich ONS.

The influence of nutritional supplement drinks on providing adequate calorie and protein intake in older adults with dementia.

OBJECTIVES: Investigate the impact of the provision of ONS on protein and energy intake from food and ability to meet protein and calorie requirements in people with dementia. DESIGN: After consent by proxy was obtained, participants took part in a cross over study comparing oral intake on an intervention day to an adjacent control day. SETTING: The study occurred in Nursing homes and hospitalised settings. PARTICIPANTS: Older adults with dementia over the age of 65 were recruited. 26 participants (aged 83.9+/-8.4years, MMSE 13.08+/-8.13) took part. Intervention (if any): On the intervention day nutritional supplement drinks were provided three times. Each drink provided 283.3+/-41.8 Kcal of energy and 13.8+/-4.7g of protein. Supplements were removed approximately 1 hour before meals were served and weighed waste (g) was obtained. MEASUREMENTS: Intake of food consumed was determined on intervention and control days using the quartile method (none, quarter, half, three quarters, all) for each meal component. RESULTS: More people achieved their energy and protein requirements with the supplement drink intervention with no sufficient impact on habitual food consumption. CONCLUSION: Findings from these 26 participants with dementia indicate that supplement drinks may be beneficial in reducing the prevalence of malnutrition within the group as more people meet their nutritional requirements. As the provision of supplement drinks is also demonstrated to have an additive effect to consumption of habitual foods these can be used alongside other measures to also improve oral intake.

Adjuvant chemotherapy in older women (ACTION) study - what did we learn from the pilot phase?

BACKGROUND: The ACTION trial was initiated to provide evidence from a randomised trial on the effects of chemotherapy in women aged over 70 years where evidence for risk and benefit are lacking. METHODS: This was a randomised, phase III clinical trial for high risk, oestrogen receptor (ER) negative/ER weakly positive early breast cancer. The trial planned to recruit 1000 women aged 70 years and older, randomised to receive 4 cycles of anthracycline chemotherapy or observation. The primary endpoint was relapse-free interval. The trial included a pilot phase to assess the acceptability and feasibility of recruitment. RESULTS: The trial opened at 43 UK centres. Information on number of patients approached was available from 38 centres. Of the 43 eligible patients that were approached, 39 were not randomised due to patients declining entry. After 10 months only 4 patients had been randomised and after discussion with the research funder, the trial was closed and funding terminated. CONCLUSION: Despite widespread support at several public meetings, input from patient groups including representation on the Trial Management Group, the trial failed to recruit due to the inability to convince patients to accept randomisation. It would therefore seem that randomising the patients to receive chemotherapy vs observation is not a viable design in the current era for this patient population.

Psychosocial impact of visual impairment in working-age adults.

AIM: To review the evidence for the presence of lower levels of psychosocial well-being in working-age adults with visual impairment and for interventions to improve such levels of psychosocial well-being. METHODS: Systematic review of quantitative studies published in English from 2001 to July 2008 that measured depression/mental health, anxiety, quality of life, social functioning or social support. RESULTS: Included were 29 studies that measured one or more outcomes (N = 52). Working-age adults with visual impairment were significantly more likely to report lower levels of mental health (mean difference = 14.51/100), social functioning (MD = 11.55/100) and quality of life. Studies regarding the prevalence of depressive symptoms produced inconsistent results but had methodological limitations. CONCLUSIONS: Future research is required into the prevalence of loneliness, anxiety and depression in adults with visual impairment, and to evaluate the effectiveness of interventions for improving psychosocial well-being such as counselling, peer support and employment programmes.

Treatment of the elderly colorectal cancer patient: SIOG expert recommendations.

Colorectal cancer (CRC) is one of the commonest malignancies of Western countries, with approximately half the incidence occurring in patients >70 years of age. Elderly CRC patients, however, are understaged, undertreated and underrepresented in clinical trials. The International Society of Geriatric Oncology created a task force with a view to assessing the potential for developing guidelines for the treatment of elderly (geriatric) CRC patients. A review of the evidence presented by the task force members confirmed the paucity of clinical trial data in elderly people and the lack of evidence-based guidelines. However, recommendations have been proposed on the basis of the available data and on the emerging evidence that treatment outcomes for fit, elderly CRC patients can be similar to those of younger patients. It is hoped that these will pave the way for formal treatment guidelines based upon solid scientific evidence in the future.

General care of the older cancer patient.

With increasing age, there are greater numbers of older people who will be diagnosed with cancer. It must be remembered that such individuals have increased frailty and have a number of geriatric syndromes and conditions particularly pertinent to older age, including incontinence, poor cognition and impaired nutrition. It is often difficult to define the effects of cancer and its treatment or complications, and separate these from the effects of normal ageing and geriatric syndromes. The documentation of poor nutrition and its management must combine knowledge from both geriatric medicine and oncology. Nutrition serves to identify key healthcare professionals who are all essential in any patient at risk or suffering from malnutrition. Incontinence must be actively sought, its cause identified and efforts made to either 'cure' it or, in certain circumstances, 'manage' it. Older patients with cancer are cared for predominantly by older relations and informal care mechanisms and special consideration of their physical and practical needs are paramount. In this area, nurses, doctors, therapists and social workers should work to identify formal and informal mechanisms to support particularly the older carer.

Effect of micronutrient supplementation on mood in nursing home residents.

One third of older people in nursing and/or residential homes have significant symptoms of depression. In younger people, deficiencies in selenium, vitamin C and folate are associated with depression. This study examines the association between micronutrient status and mood before and after supplementation. The objective was to determine whether the administration of selenium, vitamin C and folate improved mood in frail elderly nursing home residents. Mood was assessed using the Hospital Anxiety and Depression rating scale (HAD), and Montgomery-Asberg Depression Rating Scale (MADRS). Micronutrient supplementation was provided for 8 weeks in a double-blinded randomised controlled trial. Significant symptoms of depression (29%) and anxiety (24%) were found at baseline. 67% of patients had low serum concentrations of vitamin C, but no-one was below the reference range for selenium. Depression was significantly associated with selenium levels, but not with folate or vitamin C levels. No individual with a HAD depression score of >or=8, had selenium levels >1.2 microM. In those patients with higher HAD depression scores, there was a significant reduction in the score and a significant increase in serum selenium levels after 8 weeks of micronutrient supplementation. Placebo group scores were unchanged. This small study concluded that depression was associated with low levels of selenium in frail older individuals. Following 8 weeks of micronutrient supplementation, there was a significant increase in selenium levels and improved symptoms of depression occurred in a subgroup.

Privacy for defecation and fecal incontinence in older adults.

INTRODUCTION: Privacy during defecation is important to individuals and society at large and it has not been studied in older people with fecal incontinence. METHODS: One hundred twenty adults aged 65 years and with fecal incontinence who were either living in their own homes or in a nursing home or receiving care in an acute or rehabilitation elderly care ward were surveyed with a questionnaire that included questions on privacy during defecation. RESULTS: Privacy while defecating was often least achieved in the patients with fecal incontinence living in nursing homes (NH) (n=7, 23%) but usually was achieved in those living at home (H) (n=28, 93%) and by some being cared for in rehabilitation wards (R) (n=16, 53%) or in acute wards (AC) (n=15, 50%; P<.001). Very few participants with fecal incontinence were aware of leakage (NH: n=3, 10%; R: n=9, 30%; AC: n=9, 30%; H: n=15, 50%), able to clean themselves (NH: n=0, 0%; R: n=2, 7%; AC: n=5, 17%; H: n=24, 80%) or had access to patient information leaflets about fecal incontinence (NH: n=3, 10%; R: n=4, 13%; AC: n=1, 3%; H: n=16, 53%). CONCLUSION: Older people, especially those who are dependent, lack privacy during bowel movements. They are usually unaware of being incontinent of stool and are unable to clean themselves afterwards. Access to information about fecal incontinence is poor.

The knowledge of healthcare professionals regarding elderly persons' oral care.

OBJECTIVE: The aim of this study was to compare the knowledge and views of nursing staff on both acute elderly care and rehabilitation wards regarding elderly persons' oral care with that of carers in nursing homes. SUBJECTS: One hundred nurses working on acute, sub-acute and rehabilitation wards for elderly people (Group 1) and 75 carers in nursing homes (Group 2) were surveyed. DESIGN: A semi-structured questionnaire. RESULTS: Similar percentages of each group of nurses were registered with a dentist (86% and 88% respectively), although more hospital-based nurses were anxious about dental treatment compared with the nursing home group (40% and 28% respectively). More carers in nursing homes gave regular advice about oral care than the hospital-based nurses (54% and 43% respectively). Eighteen per cent of each group thought that edentulous individuals did not require regular oral care. Eighty-five per cent of hospital-based nurses and 95% of nursing home carers incorrectly thought that dentures were 'free' on the NHS. Although trends were observed between the two groups, no comparisons were statistically significant (Chi-square; level p < 0.05). CONCLUSIONS: Deficiencies exist in the knowledge of health care workers both in hospital and in the community setting, although the latter were less knowledgeable but more likely to give advice to older people.

The role of selective decontamination of the digestive tract in acute stroke.

BACKGROUND: following a stroke, morbidity and mortality is high, with aspiration pneumonia being a common complication. OBJECTIVES: to determine the levels of colonisation by and isolation of aerobic Gram-negative bacteria (AGNB) in acute stroke patients and determine the effect of selective decontamination of the digestive tract (SDD) on oral flora and whether it reduces both morbidity and mortality after an acute stroke. DESIGN: a prospective, randomised, placebo-controlled double blind trial. SETTING: acute stroke assessment units of three hospitals in the northwest of England. SUBJECTS: 203 patients admitted to hospital following a first acute stroke. METHODS: participants were randomised to SDD oral gel or placebo. Swallow was assessed on admission to hospital, and oral swabs were obtained thrice weekly. Demographic and clinical data were recorded. RESULTS: 203 patients (106 males and 97 females) participated, of whom 20 died during their hospitalisation, 19 withdrew and full follow-up was obtained for the remaining 164. A total of 122 AGNB were isolated in 105 samples from 48 patients. Abnormal swallow on admission was found in 58 patients (29%). A total of 34 patients carried a single gram-negative micro-organism that was present on one or more occasions. More than one AGNB was carried in 14 patients, and organisms were significantly more likely to be isolated from the placebo group than the active group during weeks 2 and 3 of treatment (P = 0.034, chi-squared). Seven patients in the placebo group and one in the treatment group developed pneumonia (P = 0.029, Fisher's exact test). CONCLUSIONS: high carriage of and colonisation by AGNB was found within this study, which was reduced by the addition of SDD. Although SDD reduced the presence of both organisms and documented episodes of pneumonia, mortality remained unchanged.

Cost-benefit evaluation of routine influenza immunisation in people 65-74 years of age.

OBJECTIVES: To determine the cost-effectiveness of influenza vaccination in people aged 65-74 years in the absence of co-morbidity. DESIGN: Primary research: randomised controlled trial. SETTING: Primary care. PARTICIPANTS: People without risk factors for influenza or contraindications to vaccination were identified from 20 general practitioner (GP) practices in Liverpool in September 1999 and invited to participate in the study. There were 5875/9727 (60.4%) people aged 65-74 years identified as potentially eligible and, of these, 729 (12%) were randomised. INTERVENTION: Participants were randomised to receive either influenza vaccine or placebo (ratio 3:1), with all individuals receiving pneumococcal vaccine unless administered in the previous 10 years. Of the 729 people randomised, 552 received vaccine and 177 received placebo; 726 individuals were administered pneumococcal vaccine. MAIN OUTCOME MEASURES AND METHODOLOGY OF ECONOMIC EVALUATION: GP attendance with influenza-like illness (ILI) or pneumonia (primary outcome measure); or any respiratory symptoms; hospitalisation with a respiratory illness; death; participant self-reported ILI; quality of life (QoL) measures at 2, 4 and 6 months post-study vaccination; adverse reactions 3 days after vaccination. A cost-effectiveness analysis was undertaken to identify the incremental cost associated with the avoidance of episodes of influenza in the vaccination population and an impact model was used to extrapolate the cost-effectiveness results obtained from the trial to assess their generalisability throughout the NHS. RESULTS: In England and Wales, weekly consultations for influenza and ILI remained at baseline levels (less than 50 per 100,000 population) until week 50/1999 and then increased rapidly, peaking during week 2/2000 with a rate of 231/100,000. This rate fell within the range of 'higher than expected seasonal activity' of 200-400/100,000. Rates then quickly declined, returning to baseline levels by week 5/2000. The predominant circulating strain during this period was influenza A (H3N2). Five (0.9%) people in the vaccine group were diagnosed by their GP with an ILI compared to two (1.1%) in the placebo group [relative risk (RR), 0.8; 95% confidence interval (CI) = 0.16 to 4.1]. No participants were diagnosed with pneumonia by their GP and there were no hospitalisations for respiratory illness in either group. Significantly fewer vaccinated individuals self-reported a single ILI (4.6% vs 8.9%, RR, 0.51; 95% CI for RR, 0.28 to 0.96). There was no significant difference in any of the QoL measurements over time between the two groups. Reported systemic side-effects showed no significant differences between groups. Local side-effects occurred with a significantly increased incidence in the vaccine group (11.3% vs 5.1%, p = 0.02). Each GP consultation avoided by vaccination was estimated from trial data to generate a net NHS cost of 174 pounds. CONCLUSIONS: No difference was seen between groups for the primary outcome measure, although the trial was underpowered to demonstrate a true difference. Vaccination had no significant effect on any of the QoL measures used, although vaccinated individuals were less likely to self-report ILI. The analysis did not suggest that influenza vaccination in healthy people aged 65-74 years would lead to lower NHS costs. Future research should look at ways to maximise vaccine uptake in people at greatest risk from influenza and also the level of vaccine protection afforded to people from different age and socio-economic populations.

Acute stroke predisposes to oral gram-negative bacilli -- a cause of aspiration pneumonia?

OBJECTIVES: To assess any change in the oral flora in the mouths of stroke patients during the acute and rehabilitation phases and to determine whether this is related to episodes of aspiration pneumonia and clinical outcome. MATERIALS AND METHODS: This observational study was carried out in hospital wards in a University teaching hospital. The subjects were patients immediately post-stroke and during the rehabilitation period, acute admissions and a group of healthy volunteers. An assessment of dentition and swallow in the presence or absence of oral aerobic gram-negative bacilli (AGNB) was correlated. RESULTS: Of the acute stroke patients 52% had an unsafe swallow. AGNB carriage was documented in 34% of the acute stroke group. Of the 11 patients who died 55% had AGNB, 73% had an unsafe swallow and 36% had a combination of both. CONCLUSION: AGNB is a common finding in acute stroke patients. It is not a consequence of age or acute hospitalisation and is associated with an unsafe swallow and a higher mortality.

Anxiety and depression in an older research population and their impact on clinical outcomes in a randomised controlled trial.

INTRODUCTION: Anxiety and depression are common in older people living in the community. The aim of the study was to investigate their impact on clinical outcomes during a randomised controlled trial investigating the cost benefits of influenza vaccination in fit and healthy, independent living 65-74 year olds. SUBJECTS AND METHODS: A total of 729 people were recruited. Participants completed the hospital anxiety and depression scale (HADS) and EuroQol EQ-5D quality of life questionnaire immediately before receiving vaccination and every two months for the next six months after this. Side effects three days after vaccination and Barthel score at baseline were also recorded. RESULTS: At baseline the prevalence of "definite" anxiety in this sample (HADS score > or =11) was 4% and 1.2% of individuals had definite depression (HADS score > or =11). Individuals with anxiety or depression (HADS score > or =8) were more likely to complain of systemic side effects after vaccination and have a lower Barthel index score (p<0.001). Quality of life as measured by the EQ-5D visual analogue scale was reduced (p<0.001) at all time periods in those individuals with both anxiety and depression (HADS score > or =8 on both scales). CONCLUSION: Although the prevalence of anxiety and depression in this sample was low, people with anxiety or depression were more likely to suffer from perceived side effects after influenza vaccine and have a lower Barthel and EQ-5D visual analogue score. In future studies the effect of anxiety and depression on older participants should be remembered and care taken to ensure that they do not affect results more than the intervention under study.

Side effects of influenza vaccination in healthy older people: a randomised single-blind placebo-controlled trial.

OBJECTIVES: To investigate the frequency of side effects following influenza vaccination in healthy participants aged 65-74 years. MATERIALS AND METHODS: A single-blind randomised placebo-controlled trial was performed in general practices in central Liverpool on 729 healthy individuals (341 females and 388 males) aged 65-74 (median age 68.9) years, of whom 552 received influenza vaccine and 177 received placebo. The main outcome measures were analysed from adverse reactions reported by the subjects on a postal questionnaire 3 days after vaccination. RESULTS: 724 (99.3%) questionnaires were returned. 62 (11.3%) participants who received influenza vaccination complained of local symptoms compared with 9 (5.1%) participants who received placebo (difference 6.2%; 95% CI 1.3 to 10.0%; p = 0.02). 192 (35.1%) individuals who received influenza vaccine complained of one or more systemic side effects compared with 75 (42.4%) who received placebo (difference -7.3%; 95% CI -15.6 to 0.9%; p = 0.10). CONCLUSION: Healthy people belonging to this age group can be reassured that, when compared with placebo, influenza vaccination causes few, if any, systemic side effects and only a low incidence of local side effects.

Smoking cessation.

Smoking cessation has been shown to be cost effective, even in older individuals. It is therefore important that this health promotion is not missed in this vulnerable group.

A proton magnetic resonance spectroscopy study of age-related changes in frontal lobe metabolite concentrations.

Ageing is associated with reduction of grey matter volume and it is reported that the frontal lobes are preferentially affected. We have applied quantitative magnetic resonance spectroscopy (MRS), incorporating measurement of brain tissue water content and metabolite T(2) relaxation times, to determine absolute concentrations of the putative neuronal marker N-acetylaspartate (NAA), creatine (Cr) and choline (Cho) compounds in the frontal lobe of 50 male subjects aged between 20 and 70 years (10 per decade). The fractional brain water content (beta(MR)) did not change significantly as a function of age (r = 0.07, P = 0.65) and had a mean value of 81% (CV = 2%). The concentration (in millimoles per litre brain tissue) of NAA decreased significantly with age (r = -0.42, P = 0.003), with an overall decrease of 12% between the third and seventh decades. The concentrations of Cr and Cho did not change significantly with age. The interpretation of the age-dependent decrease in NAA concentration as reflecting either a reduction in neuronal volume, number or function is discussed.