Second primary cancer risk - the impact of applying different definitions of multiple primaries: results from a retrospective population-based cancer registry study

Background: There is evidence that cancer survivors are at increased risk of second primary cancers. Changes in the prevalence of risk factors and diagnostic techniques may have affected more recent risks.<p></p> Methods: We examined the incidence of second primary cancer among adults in the West of Scotland, UK, diagnosed with cancer between 2000 and 2004 (n = 57,393). We used National Cancer Institute Surveillance Epidemiology and End Results and International Agency for Research on Cancer definitions of multiple primary cancers and estimated indirectly standardised incidence ratios (SIR) with 95% confidence intervals (CI).<p></p> Results: There was a high incidence of cancer during the first 60 days following diagnosis (SIR = 2.36, 95% CI = 2.12 to 2.63). When this period was excluded the risk was not raised, but it was high for some patient groups; in particular women aged <50 years with breast cancer (SIR = 2.13, 95% CI = 1.58 to 2.78), patients with bladder (SIR = 1.41, 95% CI = 1.19 to 1.67) and head & neck (SIR = 1.93, 95% CI = 1.67 to 2.21) cancer. Head & neck cancer patients had increased risks of lung cancer (SIR = 3.75, 95% CI = 3.01 to 4.62), oesophageal (SIR = 4.62, 95% CI = 2.73 to 7.29) and other head & neck tumours (SIR = 6.10, 95% CI = 4.17 to 8.61). Patients with bladder cancer had raised risks of lung (SIR = 2.18, 95% CI = 1.62 to 2.88) and prostate (SIR = 2.41, 95% CI = 1.72 to 3.30) cancer.<p></p> Conclusions: Relative risks of second primary cancers may be smaller than previously reported. Premenopausal women with breast cancer and patients with malignant melanomas, bladder and head & neck cancers may benefit from increased surveillance and advice to avoid known risk factors

An intervention to improve outcomes of falls in dementia: the DIFRID mixed-methods feasibility study:A mixed methods study to develop and assess the feasibility of the DIFRID intervention

Background : Fall-related injuries are a significant cause of morbidity and mortality in people with dementia (PWD). There is presently little evidence to guide the management of such injuries, and yet there are potentially substantial benefits to be gained if the outcome of these injuries could be improved. This study aimed to design an appropriate new healthcare intervention for PWD following a fall and to assess the feasibility of its delivery in the UK National Health Service. Objective (s): To determine whether it is possible to design an intervention to improve outcomes of falls in dementia; to investigate the feasibility and acceptability of the DIFRID intervention; to investigate the feasibility of a future randomised controlled trial (RCT) and data collection tools needed to evaluate the effectiveness and efficiency of the DIFRID intervention. Design : Mixed-methods feasibility study. Methods : A systematic review (using Cochrane methodology) and realist review (using RAMESES methodology) explored the existing evidence base and developed programme theories. Searches were carried out in Nov 2015 (updated Jan 2018) for effectiveness studies and August 2016 for economic studies. A prospective observational study identified service use via participant diary completion. Qualitative methods (semi-structured interviews, focus groups, and observation) were used to explore: current practice; stakeholder perspectives of the health and social care needs of PWD following a fall; ideas for intervention; and barriers and facilitators to change. Each of these datasets informed intervention development, via Delphi consensus methods. Finally, a single-arm feasibility study with embedded process evaluation was conducted. Setting : Community. Participants : PWD presenting with falls needing healthcare attention in each setting at 3 sites and their carers. Professionals delivering the intervention, responsible for training and supervision and members of the intervention team. Professionals responsible for approaching and recruiting participants. Interventions: A complex multidisciplinary therapy intervention. Physiotherapists, occupational therapists, and support workers delivered up to 22 sessions of tailored activities in the PWD’s home or local area over a period of 12 weeks. Main outcome measures: Assessment of feasibility of study procedures; assessment of the acceptability, feasibility and fidelity of intervention components; assessment of suitability and acceptability of outcome measures for PWD and carers (number of falls; quality of life; fear of falling; activities of daily living; goal setting; health utilisation; carer burden). Results : A multidisciplinary intervention delivered in PWDs’ own homes was designed based on qualitative work, realist review and recommendations of the consensus panel. The intervention was delivered to 11 PWD. The study suggested that the intervention is both feasible and acceptable to stakeholders. A number of modifications was recommended to address some of the issues arising during feasibility testing. Measurement of outcome measures was successful. Limitations : Recruitment to the feasibility study was lower than expected and therefore the intervention needs to be tested with a larger number of PWD. Conclusions : The study has highlighted the feasibility of delivering a creative, tailored, individual approach to intervention for PWD following a fall. Although the intervention required greater investment of time than usual practice, many staff valued the opportunity to work more closely with PWD and carers. Future work : We conclude that further research is now needed to refine this intervention in the context of a pilot randomised controlled trial

Feasibility of trial procedures for a randomised controlled trial of a community based group exercise intervention for falls prevention for visually impaired older people: the VIOLET study

Background Visually impaired older people (VIOP) have a higher risk of falling than their sighted peers, and are likely to avoid physical activity. The aim was to adapt the existing Falls Management Exercise (FaME) programme for VIOP, delivered in the community, and to investigate the feasibility of conducting a definitive randomised controlled trial (RCT) of this adapted intervention. Methods Two-centre randomised mixed methods pilot trial and economic evaluation of the adapted group-based FaME programme for VIOP versus usual care. A one hour exercise programme ran weekly over 12 weeks at the study sites (Newcastle and Glasgow), delivered by third sector (voluntary and community) organisations. Participants were advised to exercise at home for an additional two hours over the week. Those randomised to the usual activities group received no intervention. Outcome measures were completed at baseline, 12 and 24 weeks. The potential primary outcome was the Short Form Falls Efficacy Scale – International (SFES-I). Participants’ adherence was assessed by reviewing attendance records and self-reported compliance to the home exercises. Adherence with the course content (fidelity) by instructors was assessed by a researcher. Adverse events were collected in a weekly phone call. Results Eighteen participants, drawn from community-living VIOP were screened; 68 met the inclusion criteria; 64 participants were randomised with 33 allocated to the intervention and 31 to the usual activities arm. 94% of participants provided data at the 12 week visit and 92% at 24 weeks. Adherence was high. The intervention was found to be safe with 76% attending nine or more classes. Median time for home exercise was 50 min per week. There was little or no evidence that fear of falling, balance and falls risk, physical activity, emotional, attitudinal or quality of life outcomes differed between trial arms at follow-up. Conclusions The intervention, FaME, was implemented successfully for VIOP and all progression criteria for a main trial were met. The lack of difference between groups on fear of falling was unsurprising given it was a pilot study but there may have been other contributory factors including suboptimal exercise dose and apparent low risk of falls in participants. These issues need addressing for a future trial

Mortality rate of patients with asymptomatic primary biliary cirrhosis diagnosed at age 55 years or older is similar to that of the general population

Recent routine testing for liver function and anti-mitochondrial antibodies has increased the number of newly diagnosed patients with primary biliary cirrhosis (PBC). This study investigated the prognosis of asymptomatic PBC patients, focusing on age difference, to clarify its effect on the prognosis of PBC patients. The study was a systematic cohort analysis of 308 consecutive patients diagnosed with asymptomatic PBC. We compared prognosis between the elderly (55 years or older at the time of diagnosis) and the young patients (< 55 years). The mortality rate of the patients was also compared with that of an age- and gender-matched general population. The elderly patients showed a higher aspartate aminotransferase-to-platelet ratio, and lower alanine aminotransferase level than the young patients (P < 0.01 and P = 0.03, respectively). The two groups showed similar values for alkaline phosphatase and immunoglobulin M. Death in the young patients was more likely to be due to liver failure (71%), while the elderly were likely to die from other causes before the occurrence of liver failure (88%; P < 0.01), especially from malignancies (35%). The mortality rate of the elderly patients was not different from that of the age- and gender-matched general population (standardized mortality ratio, 1.1; 95% confidence interval, 0.6-1.7), although this rate was significantly higher than that of the young patients (P = 0.044). PBC often presents as more advanced disease in elderly patients than in the young. However, the mortality rate of the elderly patients is not different from that of an age- and gender-matched general population

Visually Impaired OLder people's Exercise programme for falls prevenTion (VIOLET): a feasibility study

This study aims to conduct a mixed methods feasibility study to inform the design and conduct of a future definitive RCT of an adapted exercise programme to prevent falls by reducing fear of falling among older people with visual impairment (OPVI). The research questions are: can an existing exercise programme be adapted for OPVI and successfully delivered in the community; is it feasible to conduct an RCT of this intervention and what are the features of a future definitive trial? We propose to: (i) Adapt an existing exercise programme with the full involvement of OPVI and practitioners; (ii) Run a feasibility study in 2 sites to test our proposed measures, trial processes and recruitment; explore acceptability of the intervention; fidelity of and compliance with the intervention. Two stakeholder panels will be established including OPVI aged 60 and over from Newcastle Society for Blind People (NSBP) and Visibility in Glasgow, practitioners and researchers. They will work together to adapt the FaME programme, which is known to be effective in reducing falls in frequent fallers, so that the methods are acceptable for OPVI, whilst retaining the effective components of the exercise. The panels will meet 4 times to adapt the intervention and contribute to decisions on outcome measures and data collection. During this time we will identify OPVI wishing to act as expert stakeholders in the subsequent WPs. OPVI aged 60+ will be recruited from low vision clinics and voluntary organisations and randomised into the intervention or comparator arm. Those in the comparator arm will receive no intervention, but will be offered it after final data collection. The core components of the adapted exercise programme aim to strengthen leg muscles and retrain balance. However, the detail of the methods and timing will be decided by the stakeholder panel. The programme is likely to run once a week over 12 weeks, with each session lasting up to one hour. The final form of delivery will be one of the outcomes of the PPI work in WP1. Participants will be provided with instructions and equipment to do the exercises at home if they wish. The intervention will be delivered by exercise instructors engaged by Health Works, Newcastle and Visibility, Glasgow, in venues agreed with participants. The final primary outcome of the future RCT will be decided by the responsiveness to change, participant burden and participant feedback from this study. The likely candidate primary outcome is fear of falling (Short FES-I scale). The main secondary outcomes will be: activity avoidance; balance/falls risk; number of falls; quality of life; loneliness; depression; adherence to exercise programme; self-reported home exercising. An estimate of cost effectiveness and cost utility of the intervention will be undertaken. In-depth interviews with a sample of OPVI will be conducted to explore their reasons for taking part/not taking part; factors that facilitate/hinder them from participating in exercise groups; their experiences of the recruitment and randomisation process and views on the outcome measures; their experience of the adapted intervention. The interviews will highlight site specific issues to consider for the definitive RCT. Structured interviews will be undertaken with commissioners and practitioners to explore their perspectives on the application of the intervention

Some considerations for the communication of results of air pollution health effects tracking

Communicating effectively and efficiently on air quality and its health impacts is an important but difficult and complex task. It requires careful consideration of the audience one wants to reach, the messages one is trying to present, the venue through which the message will be delivered. The audience, context, technique, and content factors may affect how well it is heard and how appropriately it is interpreted. In this short paper, I describe many of these concerns and provide some suggestions for how best to address them. However, since every audience differs in goals, characteristics, and nature, what is most important is implementing an effective communications program. This program should include frequent two-way communication, repeated and on-going evaluation of how well the audience understands the messages, and consideration of how to improve the delivery

Visually Impaired OLder people\u27s Exercise programme for falls prevenTion (VIOLET): a feasibility study protocol

Introduction: In the UK, 1 in 5 people aged 75 and over live with sight loss. Visually impaired older people (VIOP) have an above average incidence of falls and 1.3-1.9 times more likely to experience hip fractures, than the general population. Older people with eye diseases are similar to 3 times more likely than those with good vision, to limit activities due to fear of falling. This feasibility study aims to adapt the group-based Falls Management Exercise (FaME) programme to the needs of VIOP and carry out an external pilot trial to inform the design of a future definitive randomised controlled trial.Methods and design: A UK based 2-centre mixed methods, randomised, feasibility study will be conducted over 28 months. Stakeholder panels, including VIOP, will make recommendations for adaptations to an existing exercise programme (FaME), to meet the needs of VIOP, promoting uptake and adherence, while retaining required effective components of the exercise programme. 80 VIOP aged 60 and over, living at home, ambulant with or without a walking aid, will be recruited in Newcastle (n=40) and Glasgow (n=40) through National Health Service (NHS) Trusts and third sector partners. Participants randomised into the intervention arm will receive the adapted FaME programme. Participants randomised into the control arm will continue with usual activity. Outcomes are, recruitment rate, adherence and validated measures including fear of falling and quality of life. Postintervention in-depth qualitative interviews will be conducted with a purposive sample of VIOP (N=10). Postural stability instructors will be interviewed, before trial-specific training and following the intervention.Ethics and dissemination: Ethics approval was secured through the National Research Ethics Service (NRES) Committee North East, Newcastle and North Tyneside 2. Glasgow Caledonian University was approved as a non-NHS site with local ethics approval. Findings will be disseminated through peer-reviewed journals, national and international conferences

Randomised controlled trial with economic and process evaluations of domiciliary welfare rights advice for socioeconomically disadvantaged older people recruited via primary health care (the Do-Well study)

Background Welfare rights advice services are effective at maximising previously unclaimed welfare benefits, but their impact on health has not been evaluated. Objective To establish the acceptability, cost-effectiveness and effect on health of a domiciliary welfare rights advice service targeting older people, compared with usual practice. Design A pragmatic, individually randomised, parallel-group, single-blinded, wait-list controlled trial, with economic and process evaluations. Data were collected by interview at baseline and 24 months, and by self-completion questionnaire at 12 months. Qualitative interviews were undertaken with purposive samples of 50 trial participants and 17 professionals to explore the intervention’s acceptability and its perceived impacts. Setting Participants’ homes in North East England, UK. Participants A total of 755 volunteers aged ≥ 60 years, living in their own homes, fluent in English and not terminally ill, recruited from the registers of 17 general practices with an Index of Multiple Deprivation within the most deprived two-fifths of the distribution for England, and with no previous access to welfare rights advice services. Interventions Welfare rights advice, comprising face-to-face consultations, active assistance with benefit claims and follow-up as required until no longer needed, delivered in participants’ own homes by a qualified welfare rights advisor. Control group participants received usual care until the 24-month follow-up, after which they received the intervention. Main outcome measures The primary outcome was health-related quality of life (HRQoL), assessed using the CASP-19 (Control, Autonomy, Self-realisation and Pleasure) score. The secondary outcomes included general health status, health behaviours, independence and hours per week of care, mortality and changes in financial status. Results A total of 755 out of 3912 (19%) general practice patients agreed to participate and were randomised (intervention, n = 381; control, n = 374). In the intervention group, 335 participants (88%) received the intervention. A total of 605 (80%) participants completed the 12-month follow-up and 562 (75%) completed the 24-month follow-up. Only 84 (22%) intervention group participants were awarded additional benefits. There was no significant difference in CASP-19 score between the intervention and control groups at 24 months [adjusted mean difference 0.3, 95% confidence interval (CI) –0.8 to 1.5], but a significant increase in hours of home care per week in the intervention group (adjusted difference 26.3 hours/week, 95% CI 0.8 to 56.1 hours/week). Exploratory analyses found a weak positive correlation between CASP-19 score and the amount of time since receipt of the benefit (0.39, 95% CI 0.16 to 0.58). The qualitative data suggest that the intervention was acceptable and that receipt of additional benefits was perceived by participants and professionals as having had a positive impact on health and quality of life. The mean cost was £44 per participant, the incremental mean health gain was 0.009 quality-adjusted life-years (QALYs) (95% CI –0.038 to 0.055 QALYs) and the incremental cost-effectiveness ratio was £1914 per QALY gained. Conclusions The trial did not provide sufficient evidence to support domiciliary welfare rights advice as a means of promoting health among older people, but it yielded qualitative findings that suggest important impacts on HRQoL. The intervention needs to be better targeted to those most likely to benefit. Future work Further follow-up of the trial could identify whether or not outcomes diverge among intervention and control groups over time. Research is needed to better understand how to target welfare rights advice to those most in need. Trial registration Current Controlled Trials ISRCTN37380518

Developing an intervention for fall-related injuries in dementia (DIFRID): an integrated, mixed-methods approach

This is the final version. Available on open access from BMC via the DOI in this recordThe datasets generated during and/or analysed during the current study are available from the corresponding author (LA) on reasonable request. The data are not publicly available due to them containing information that could compromise research participant confidentialityBackground: Falls in people with dementia can result in a number of physical and psychosocial consequences. However, there is limited evidence to inform how best to deliver services to people with dementia following a fall. The aim of the DIFRID study was to determine the feasibility of developing and implementing a new intervention to improve outcomes for people with dementia with fall-related injuries; this encompasses both short-term recovery and reducing the likelihood of future falls. This paper details the development of the DIFRID intervention. Methods: The intervention was designed using an integrated, mixed-methods approach. This involved a realist synthesis of the literature and qualitative data gathered through interviews and focus groups with health and social care professionals (n=81). An effectiveness review and further interviews and observation were also conducted and are reported elsewhere. A modified Delphi panel approach with 24 experts was then used to establish a consensus on how the findings should translate into a new intervention. After feedback from key stakeholders (n=15) on the proposed model, the intervention was manualised and training developed. Results: We identified key components of a new intervention covering three broad areas: • Ensuring that the circumstances of rehabilitation are optimised for people with dementia • Compensating for the reduced ability of people with dementia to self-manage • Equipping the workforce with the necessary skills and information to care for this patient group Consensus was achieved on 54 of 69 statements over two rounds of the Delphi surveys. The statements were used to model the intervention and finalise the accompanying manual and protocol for a feasibility study. Stakeholder feedback was generally positive and the majority of suggested intervention components were approved. The proposed outcome was a 12-week complex multidisciplinary intervention primarily based at the patient’s home. Conclusions: A new intervention has been developed to improve outcomes for people with dementia following a fall requiring healthcare attention. The feasibility of this intervention is currently being tested.National Institute for Health Research (NIHR