Screening in the community to reduce fractures in older women (SCOOP): a randomised controlled trial.

BACKGROUND: Despite effective assessment methods and medications targeting osteoporosis and related fractures, screening for fracture risk is not currently advocated in the UK. We tested whether a community-based screening intervention could reduce fractures in older women. METHODS: We did a two-arm randomised controlled trial in women aged 70-85 years to compare a screening programme using the Fracture Risk Assessment Tool (FRAX) with usual management. Women were recruited from 100 general practitioner (GP) practices in seven regions of the UK: Birmingham, Bristol, Manchester, Norwich, Sheffield, Southampton, and York. We excluded women who were currently on prescription anti-osteoporotic drugs and any individuals deemed to be unsuitable to enter a research study (eg, known dementia, terminally ill, or recently bereaved). The primary outcome was the proportion of individuals who had one or more osteoporosis-related fractures over a 5-year period. In the screening group, treatment was recommended in women identified to be at high risk of hip fracture, according to the FRAX 10-year hip fracture probability. Prespecified secondary outcomes were the proportions of participants who had at least one hip fracture, any clinical fracture, or mortality; and the effect of screening on anxiety and health-related quality of life. This trial is registered with the International Standard Randomised Controlled Trial registry, number ISRCTN 55814835. FINDINGS: 12 483 eligible women were identified and participated in the trial, and 6233 women randomly assigned to the screening group between April 15, 2008, and July 2, 2009. Treatment was recommended in 898 (14%) of 6233 women. Use of osteoporosis medication was higher at the end of year 1 in the screening group compared with controls (15% vs 4%), with uptake particularly high (78% at 6 months) in the screening high-risk subgroup. Screening did not reduce the primary outcome of incidence of all osteoporosis-related fractures (hazard ratio [HR] 0·94, 95% CI 0·85-1·03, p=0·178), nor the overall incidence of all clinical fractures (0·94, 0·86-1·03, p=0·183), but screening reduced the incidence of hip fractures (0·72, 0·59-0·89, p=0·002). There was no evidence of differences in mortality, anxiety levels, or quality of life. INTERPRETATION: Systematic, community-based screening programme of fracture risk in older women in the UK is feasible, and could be effective in reducing hip fractures. FUNDING: Arthritis Research UK and Medical Research Council.

Acceptability of screening to prevent osteoporotic fractures: a qualitative study with older women.

BACKGROUND: Osteoporotic fractures have a detrimental impact on health and quality of life, are more common in older women and are costly to treat. Screening to identify older women at high risk of fracture has the potential to offer substantial benefits. Understanding women's and professionals' experiences of screening will inform the implementation of screening in routine care. OBJECTIVE: To explore the views of older women and GPs about the acceptability of screening to prevent fractures. METHODS: A qualitative study conducted within a multi-centre randomized controlled trial of the effectiveness and cost-effectiveness of screening women aged 70-85 years for the prevention of fractures; 30 women randomized to the trial screening group and 15 GPs were recruited from general practices in North Somerset and Norfolk, UK. All 30 women and 11 of the GPs participated in face-to-face semi-structured interviews. Four GPs participated in a focus group. Data were analysed thematically, using the Framework Approach. RESULTS: Women and GPs viewed screening positively, recognizing its potential to improve fracture prevention and future health. Attending screening was not found to result in anxiety or excessive activity restriction. Demonstrating cost-effectiveness was key to the acceptability of screening amongst GPs. Implementing similar screening in routine care would require consideration of access to bone density scans, information provision to participants and mode of administration. CONCLUSIONS: Our findings suggest an effective and cost-effective screening programme to reduce osteoporotic fractures could be implemented in routine care and would be well received by women and GPs.

The "unknown territory" of goal-setting: Negotiating a novel interactional activity within primary care doctor-patient consultations for patients with multiple chronic conditions.

Goal-setting is widely recommended for supporting patients with multiple long-term conditions. It involves a proactive approach to a clinical consultation, requiring doctors and patients to work together to identify patient's priorities, values and desired outcomes as a basis for setting goals for the patient to work towards. Importantly it comprises a set of activities that, for many doctors and patients, represents a distinct departure from a conventional consultation, including goal elicitation, goal-setting and action planning. This indicates that goal-setting is an uncertain interactional space subject to inequalities in understanding and expectations about what type of conversation is taking place, the roles of patient and doctor, and how patient priorities may be configured as goals. Analysing such spaces therefore has the potential for revealing how the principles of goal-setting are realised in practice. In this paper, we draw on Goffman's concept of 'frames' to present an examination of how doctors' and patients' sense making of goal-setting was consequential for the interactions that followed. Informed by Interactional Sociolinguistics, we used conversation analysis methods to analyse 22 video-recorded goal-setting consultations with patients with multiple long-term conditions. Data were collected between 2016 and 2018 in three UK general practices as part of a feasibility study. We analysed verbal and non-verbal actions for evidence of GP and patient framings of consultation activities and how this was consequential for setting goals. We identified three interactional patterns: GPs checking and reframing patients' understanding of the goal-setting consultation, GPs actively aligning with patients' framing of their goal, and patients passively and actively resisting GP framing of the patient goals. These reframing practices provided "telling cases" of goal-setting interactions, where doctors and patients need to negotiate each other's perspectives but also conflicting discourses of patient-centredness, population-based evidence for treating different chronic illnesses and conventional doctor-patient relations.

Setting goals with patients living with multimorbidity: qualitative analysis of general practice consultations.

BACKGROUND: Establishing patient goals is widely recommended as a way to deliver care that matters to the individual patient with multimorbidity, who may not be well served by single-disease guidelines. Though multimorbidity is now normal in general practice, little is known about how doctors and patients should set goals together. AIM: To determine the key components of the goal-setting process in general practice. DESIGN AND SETTING: In-depth qualitative analysis of goal-setting consultations in three UK general practices, as part of a larger feasibility trial. Focus groups with participating GPs and patients. The study took place between November 2016 and July 2018. METHOD: Activity analysis was applied to 10 hours of video-recorded doctor-patient interactions to explore key themes relating to how goal setting was attempted and achieved. Core challenges were identified and focus groups were analysed using thematic analysis. RESULTS: A total of 22 patients and five GPs participated. Four main themes emerged around the goal-setting process: patient preparedness and engagement; eliciting and legitimising goals; collaborative action planning; and GP engagement. GPs were unanimously positive about their experience of goal setting and viewed it as a collaborative process. Patients liked having time to talk about what was most important to them. Challenges included eliciting goals from unprepared patients, and GPs taking control of the goal rather than working through it with the patient. CONCLUSION: Goal setting required time and energy from both parties. GPs had an important role in listening and bearing witness to their patients' goals. Goal setting worked best when both GP and patient were prepared in advance.

Can goal-setting for patients with multimorbidity improve outcomes in primary care? Cluster randomised feasibility trial.

INTRODUCTION: Goal-setting is recommended for patients with multimorbidity, but there is little evidence to support its use in general practice. OBJECTIVE: To assess the feasibility of goal-setting for patients with multimorbidity, before undertaking a definitive trial. DESIGN AND SETTING: Cluster-randomised controlled feasibility trial of goal-setting compared with control in six general practices. PARTICIPANTS: Adults with two or more long term health conditions and at risk of unplanned hospital admission. INTERVENTIONS: General practitioners (GPs) underwent training and patients were asked to consider goals before an initial goal-setting consultation and a follow-up consultation 6 months later. The control group received usual care planning. OUTCOME MEASURES: Health-related quality of life (EQ-5D-5L), capability (ICEpop CAPability measure for Older people), Patient Assessment of Chronic Illness Care and healthcare use. All consultations were video-recorded or audio-recorded, and focus groups were held with participating GPs and patients. RESULTS: Fifty-two participants were recruited with a response rate of 12%. Full follow-up data were available for 41. In the goal-setting group, mean age was 80.4 years, 54% were female and the median number of prescribed medications was 13, compared with 77.2 years, 39% female and 11.5 medications in the control group. The mean initial consultation time was 23.0 min in the goal-setting group and 19.2 in the control group. Overall 28% of patient participants had no cognitive impairment. Participants set between one and three goals on a wide range of subjects, such as chronic disease management, walking, maintaining social and leisure interests, and weight management. Patient participants found goal-setting acceptable and would have liked more frequent follow-up. GPs unanimously liked goal-setting and felt it delivered more patient-centred care, and they highlighted the importance of training. CONCLUSIONS: This goal-setting intervention was feasible to deliver in general practice. A larger, definitive study is needed to test its effectiveness. TRIAL REGISTRATION NUMBER: ISRCTN13248305; Post-results.

The Cost-Effectiveness of Screening in the Community to Reduce Osteoporotic Fractures in Older Women in the UK: Economic Evaluation of the SCOOP Study.

The SCOOP study was a two-arm randomized controlled trial conducted in the UK in 12,483 eligible women aged 70 to 85 years. It compared a screening program using the FRAX® risk assessment tool in addition to bone mineral density (BMD) measures versus usual management. The SCOOP study found a reduction in the incidence of hip fractures in the screening arm, but there was no evidence of a reduction in the incidence of all osteoporosis-related fractures. To make decisions about whether to implement any screening program, we should also consider whether the program is likely to be a good use of health care resources, ie, is it cost-effective? The cost per gained quality adjusted life year of screening for fracture risk has not previously been demonstrated in an economic evaluation alongside a clinical trial. We conducted a "within trial" economic analysis alongside the SCOOP study from the perspective of a national health payer, the UK National Health Service (NHS). The main outcome measure in the economic analysis was the cost per quality adjusted life year (QALY) gained over a 5-year time period. We also estimated cost per osteoporosis-related fracture prevented and the cost per hip fracture prevented. The screening arm had an average incremental QALY gain of 0.0237 (95% confidence interval -0.0034 to 0.0508) for the 5-year follow-up. The incremental cost per QALY gained was £2772 compared with the control arm. Cost-effectiveness acceptability curves indicated a 93% probability of the intervention being cost-effective at values of a QALY greater than £20,000. The intervention arm prevented fractures at a cost of £4478 and £7694 per fracture for osteoporosis-related and hip fractures, respectively. The current study demonstrates that a systematic, community-based screening program of fracture risk in older women in the UK represents a highly cost-effective intervention. © 2018 The Authors. Journal of Bone and Mineral Research Published by Wiley Periodicals, Inc.

Management of Patients With High Baseline Hip Fracture Risk by FRAX Reduces Hip Fractures-A Post Hoc Analysis of the SCOOP Study.

The Screening for Osteoporosis in Older Women for the Prevention of Fracture (SCOOP) study was a community-based screening intervention in women aged 70 to 85 years in the United Kingdom. In the screening arm, licensed osteoporosis treatments were recommended in women identified to be at high risk of hip fracture using the FRAX risk assessment tool (including bone mineral density measurement). In the control arm, standard care was provided. Screening led to a 28% reduction in hip fractures over 5 years. In this planned post hoc analysis, we wished to examine for interactions between screening effectiveness on fracture outcome (any, osteoporotic, and hip fractures) on the one hand and baseline FRAX 10-year probability of hip fracture on the other. All analyses were conducted on an intention-to-treat basis, based on the group to which women were randomized, irrespective of whether screening was completed. Of 12,483 eligible participants, 6233 women were randomized to screening, with treatment recommended in 898 (14.4%). No evidence of an effect or interaction was observed for the outcomes of any fracture or osteoporotic fracture. In the screening arm, 54 fewer hip fractures were observed than in the control arm (164 versus 218, 2.6% versus 3.5%), and commensurate with treatment being targeted to those at highest hip fracture risk, the effect on hip fracture increased with baseline FRAX hip fracture probability (p = 0.021 for interaction); for example, at the 10th percentile of baseline FRAX hip probability (2.6%), there was no evidence that hip fractures were reduced (hazard ratio [HR] = 0.93; 95% confidence interval [CI] 0.71 to 1.23), but at the 90th percentile (16.6%), there was a 33% reduction (HR = 0.67; 95% CI 0.53 to 0.84). Prior fracture and parental history of hip fracture positively influenced screening effectiveness on hip fracture risk. We conclude that women at high risk of hip fracture based on FRAX probability are responsive to appropriate osteoporosis management. © 2018 American Society for Bone and Mineral Research.

Relationship between the Mediterranean dietary pattern and musculoskeletal health in children, adolescents, and adults: systematic review and evidence map.

CONTEXT: An understanding of the modifiable effects of diet on bone and skeletal muscle mass and strength over the life course will help inform strategies to reduce age-related fracture risk. The Mediterranean diet is rich in nutrients that may be important for optimal musculoskeletal health. The aim of this systematic review was to investigate the relationship between a Mediterranean diet and musculoskeletal outcomes (fracture, bone density, osteoporosis, sarcopenia) in any age group. Ten electronic databases were searched. Randomized controlled trials and prospective cohort studies that investigated a traditional Mediterranean diet, published in any language, were eligible. Studies using other designs or other definitions of the Mediterranean diet were collated separately in an evidence map. Details on study design, methods, population, dietary intervention or exposure, length of follow-up, and effect on or association with musculoskeletal outcomes were extracted. The search yielded 1738 references. Data from eligible randomized controlled trials (n = 0) and prospective cohort studies (n = 3) were synthesized narratively by outcome for the systematic review. Two of these studies reported on hip fracture incidence, but results were contradictory. A third study found no association between the Mediterranean diet and sarcopenia incidence. Overall, the systematic review and evidence map demonstrate a lack of research to understand the relationship between the Mediterranean diet and musculoskeletal health in all ages. PROSPERO registration number IDCRD42016037038.

Enclosing a pen reduced time to response to questionnaire mailings.

OBJECTIVES: To assess the effectiveness of including a pen in postal questionnaires on response rate, necessity of reminders, time to response, and completeness of response to the primary outcome question (POQ). STUDY DESIGN AND SETTING: A two-arm randomized controlled trial (RCT) embedded within the screening of older women for prevention of fracture trial (SCOOP). Women, aged 70-75 years, were randomized to receive a pen with their questionnaire (n = 3,826) or to receive the questionnaire alone (n = 3,829). The results were combined with another embedded RCT in a meta-analysis. RESULTS: A response rate of 92.4% was observed in the pen group compared with 91.3% in the control group (odds ratio [OR] = 1.16; 95% confidence interval [CI]: 0.98, 1.37; P = 0.08). There was a difference in reminders required (OR = 0.88; 95% CI: 0.79, 0.98; P = 0.02), time to response (hazard ratio = 1.06; 95% CI: 1.01, 1.11; P = 0.01) and some difference in the completeness of response to the POQ (OR = 1.18; 95% CI: 1.00, 1.39; P = 0.05). The pooled OR from the meta-analysis for response rate was 1.21 (95% CI: 1.05, 1.39; P = 0.01). CONCLUSION: Inclusion of a pen with postal questionnaires potentially has a positive impact on response rates and the number of reminders required. There may be some reduction in time to response. Studies of different participant groups are needed to test the effectiveness over more diverse populations.

Prior notification of trial participants by newsletter increased response rates: a randomized controlled trial.

OBJECTIVE: To assess the effectiveness of prenotification using a newsletter to increase questionnaire response rates within a randomized controlled trial (RCT). STUDY DESIGN AND SETTING: An RCT set within the context of the Medical Research Council's SCOOP trial of screening older women for fracture risk. RESULTS: A subsample of SCOOP participants were randomized in equal numbers to receive a newsletter approximately 6 weeks before the follow-up questionnaire or no newsletter. Of the 1,342 participants in the newsletter group, 1,291 (96.2%) returned their 24-month follow-up questionnaire compared with 1,271 of the 1,344 participants who were not allocated to receive the newsletter (94.6%). The difference of 1.6% was statistically significant (P=0.05), with an odds ratio (OR) of 1.45 (95% confidence interval [CI]: 1.01, 2.10). The newsletter and no newsletter groups required a similar number of reminders (OR 0.88, 95% CI: 0.73, 1.06), had a similar number with a complete primary outcome (OR 0.95, 95% CI: 0.57, 1.58), and took a similar time to respond (log rank 1.30, P=0.25). CONCLUSIONS: This study supports previous research that suggests that prenotification increases survey response rate: albeit a small absolute increase. No previous study has shown this to be so within the context of patients enrolled within an RCT. Trials that use newsletters to keep their participants informed of the study's progress should use the newsletter as a prenotification device as this will increase overall response rates.

Risk, significance and biomedicalisation of a new population: older women's experience of osteoporosis screening.

This article explores the illness experience associated with being diagnosed at risk of a long term chronic condition and discusses the implications of an emergent form of predictive medicine. We report on findings from a study involving 30 older women between the ages of 73-85 years of age recently screened for osteoporosis and informed that they are at a higher than average risk of breaking a bone in the next 10 years, but not formally diagnosed with osteoporosis. Data were gathered by the Adherence to Osteoporosis Medicine (ATOM) study using in-depth interviews with women in their own homes in Norfolk & Suffolk, UK in 2009-2010. We analyse and discuss the significance participants give to their new fracture risk status and consider the practical, physical and existential consequences of this 'diagnosis'. The findings are discussed under three broad themes: Predictive technology, meaning and the risk-of-illness experience; knowledge, understanding and the embodiment of fracture risk status; and, social implications of biomedicine for an ageing population. We argue that screening for osteoporosis and assessment of fracture risk can be understood as a process of biomedicalisation of ageing and bone health. This article offers insight into the meaning of risk status as an illness experience for older women. We conclude by discussing how biomedicalisation of a new population through diagnosis of fracture risk status has significance and consequence at both the individual and the societal level expanding the population of older women labelled at risk and increasing demand for biomedical tests and prescribed medication for the prevention of disease.

Home-based medication review in a high risk elderly population in primary care--the POLYMED randomised controlled trial.

OBJECTIVE: To assess whether home-based medication review by a pharmacist for at-risk older patients in a primary care setting can reduce hospital admissions. DESIGN: Randomised controlled trial comparing home-based medication review with standard care. SETTING: Home-based medication review of 136 patients registered with one general practice. METHOD: Study participants were over 80 years of age, living at home, taking four or more medicines, and had at least one additional medicines-related risk factor. The intervention comprised two home visits by a community pharmacist who educated the patient/carer about their medicines, noted any pharmaceutical care issues, assessed need for an adherence aid, and subsequently met with the lead GP to agree on actions. MAIN OUTCOME MEASURE: Total non-elective hospital admissions within 6 months. Secondary outcomes included number of deaths, care home admissions and quality of life (EQ-5d). Impact on number of medicines prescribed was also assessed. RESULTS: At 6 months, no difference in hospital admissions (21 intervention versus 20 control P = 0.80), and no difference in care home admissions or deaths were detected between groups. There was a small (non-significant) decrease in quality of life in the intervention group. There was a statistically significant reduction in the mean number of medicines prescribed ( -0.87 items in favour of the intervention group, 95% confidence interval -1.66 to -0.08, P = 0.03). CONCLUSIONS: No positive impact on clinical outcomes or quality of life was demonstrated, however, this intervention did appear to reduce prescribing. This is in line with other evidence and suggests that this form of intervention may not have a clear health gain, but may lead to modest savings in terms of reduced prescribing. Future research should focus on whether such a prescribing effect would make this type of intervention cost effective.

Effectiveness of visits from community pharmacists for patients with heart failure: HeartMed randomised controlled trial.

OBJECTIVE: To test whether a drug review and symptom self management and lifestyle advice intervention by community pharmacists could reduce hospital admissions or mortality in heart failure patients. DESIGN: Randomised controlled trial. SETTING: Home based intervention in heart failure patients. PARTICIPANTS: 293 patients diagnosed with heart failure were included (149 intervention, 144 control) after an emergency admission. INTERVENTION: Two home visits by one of 17 community pharmacists within two and eight weeks of discharge. Pharmacists reviewed drugs and gave symptom self management and lifestyle advice. Controls received usual care. MAIN OUTCOME MEASURES: The primary outcome was total hospital readmissions at six months. Secondary outcomes included mortality and quality of life (Minnesota living with heart failure questionnaire and EQ-5D). RESULTS: Primary outcome data were available for 291 participants (99%). 136 (91%) intervention patients received one or two visits. 134 admissions occurred in the intervention group compared with 112 in the control group (rate ratio=1.15, 95% confidence interval 0.89 to 1.48; P=0.28, Poisson model). 30 intervention patients died compared with 24 controls (hazard ratio=1.18, 0.69 to 2.03; P=0.54). Although EQ-5D scores favoured the intervention group, Minnesota living with heart failure questionnaire scores favoured controls; neither difference was statistically significant. CONCLUSION: This community pharmacist intervention did not lead to reductions in hospital admissions in contrast to those found in trials of specialist nurse led interventions in heart failure. Given that heart failure accounts for 5% of hospital admissions, these results present a problem for policy makers who are faced with a shortage of specialist provision and have hoped that skilled community pharmacists could produce the same benefits. TRIAL REGISTRATION NUMBER: ISRCTN59427925.

Does home based medication review keep older people out of hospital? The HOMER randomised controlled trial.

OBJECTIVE: To determine whether home based medication review by pharmacists affects hospital readmission rates among older people. DESIGN: Randomised controlled trial. SETTING: Home based medication review after discharge from acute or community hospitals in Norfolk and Suffolk. PARTICIPANTS: 872 patients aged over 80 recruited during an emergency admission (any cause) if returning to own home or warden controlled accommodation and taking two or more drugs daily on discharge. INTERVENTION: Two home visits by a pharmacist within two weeks and eight weeks of discharge to educate patients and carers about their drugs, remove out of date drugs, inform general practitioners of drug reactions or interactions, and inform the local pharmacist if a compliance aid is needed. Control arm received usual care. MAIN OUTCOME MEASURE: Total emergency readmissions to hospital at six months. Secondary outcomes included death and quality of life measured with the EQ-5D. RESULTS: By six months 178 readmissions had occurred in the control group and 234 in the intervention group (rate ratio = 1.30, 95% confidence interval 1.07 to 1.58; P = 0.009, Poisson model). 49 deaths occurred in the intervention group compared with 63 in the control group (hazard ratio = 0.75, 0.52 to 1.10; P = 0.14). EQ-5D scores decreased (worsened) by a mean of 0.14 in the control group and 0.13 in the intervention group (difference = 0.01, -0.05 to 0.06; P = 0.84, t test). CONCLUSIONS: The intervention was associated with a significantly higher rate of hospital admissions and did not significantly improve quality of life or reduce deaths. Further research is needed to explain this counterintuitive finding and to identify more effective methods of medication review.

Assessing quality of life in the elderly: a direct comparison of the EQ-5D and AQoL.

As more research is undertaken on the elderly, accurately assessing changes in their quality of life becomes increasingly important. Generic instruments are the most popular method to assess quality of life, and one of the most widely used is the EQ-5D. However, the range of dimensions, sensitivity of scales and completion rates have been raised as concerns when using this measure with the elderly. The AQoL is a newer instrument which offers greater richness in dimensions of health covered, and potentially offers greater sensitivity to changes in quality of life. This paper presents the results of a 'head-to-head' comparison of the EQ-5D and AQoL in terms of practicality, construct validity, agreement (of absolute scores and their change over time) and sensitivity to change, as part of a randomised controlled trial in the elderly. Poor agreement was found between both the absolute scores from each instrument and change in scores over time. Although the AQoL appeared to have more favourable construct validity, the EQ-5D was easier to administer, had a higher completion rate, and appeared more sensitive to change. We conclude that the AQoL is probably less well suited to measuring health status in a very elderly population than the EQ-5D.