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Background: The measure of disease frequency most widely used to report healthcare-associated infection (HAI) is the point-prevalence survey. Incidence studies are rarely performed due to time and cost constraints; they show which patients are affected by HAI, when and where, and inform planning and design of infection prevention and control (IPC) measures. Aim: To determine the epidemiology of HAI within a general and a teaching hospital in Scotland. Methods: A prospective observational incidence study was undertaken for one year from April 2018 using data collected as part of the Evaluation of Cost of Nosocomial Infection (ECONI) study. A novel, robust approach was undertaken, using record linkage to national administrative data to provide full admission and discharge information. Cases were recorded if they met international HAI definitions. Findings: Incidence of HAI for the combined hospitals was 250 HAI cases per 100,000 acute occupied bed-days (AOBD). Highest frequency was in urinary tract (51.2 per 100,000 AOBD), bloodstream (44.7), and lower respiratory tract infection (42.2). The most frequently reported organisms were Escherichia coli, Staphylococcus aureus, and norovirus. Incidence of HAI was higher in older people and emergency cases. There was an increase in the rate of HAI in summer months (pneumonia, respiratory, surgical, and gastrointestinal infection) and in winter months norovirus gastrointestinal infection (P < 0.0001). The highest incidence specialties were intensive care, renal medicine, and cardiothoracic surgery. HAI occurred at a median of 9 days (interquartile range: 4–19) after admission. Incidence data were extrapolated to provide an annual national estimate of HAI in NHS Scotland of 7437 (95% confidence interval: 7021–7849) cases. Conclusion: This study provides a unique overview of incidence of HAI and identifies the burden of HAI at the national level for the first time. Understanding the incidence in different clinical settings, at different times, will allow targeting of IPC measures to those patients who would benefit the most.

Abstract Recent policy focus is on the ‘non-obvious’ role of community-based organisations in tackling causes of poor health, such as social exclusion. Men’s Sheds are a type of community-based organisation offering health and wellbeing benefits to men, despite this not being the explicit reason they exist. A qualitative study was conducted in Scotland to identify sustainability challenges that impact on the ability of Sheds to become a formal healthcare service. Findings showed that a reliance on ageing and retired volunteers to undertake operational tasks and generate income to fund activities affected the ability of Sheds to sustain and develop. Further, members preferred their Sheds to remain informal and flexible to fit their specific needs. Although Sheds are recognised for their health and wellbeing benefits to men, policymakers must recognise that formalising their activities might detract from the Shed’s primary aims. This paper summarises specific policy implications and recommendations, taking into consideration tensions between the expectations placed on Sheds to expand into formal healthcare delivery, and the needs of Shed users. Highlights: Men’s Shed are known for their ability to contribute to men’s health and wellbeing. The potential of Shed to take on a formal healthcare role is questionable because of a reliance on ageing and retired volunteers and a preference to remain informal. Policymakers must recognise that although Sheds might be well placed to offer formal health care this may detract from their primary aims.

Summary Background Surgical site infections (SSIs) present a significant burden to healthcare and patients in terms of excess length of stay, distress, disability and death. SSI risk and the associated economic burden may be reduced through adherence to prevention guidelines although the irreducible minimum is unclear. Aim To evaluate the methods used to estimate the cost-effectiveness of prevention strategies for all SSIs. Methods PubMed, Medline, CINAHL, and UK National Health Service Economic Evaluation Database were searched from inception to January 2020 to identify English language economic evaluation studies, embedded economic evaluations, and studies with some analysis in relation to cost and benefit in adult patients receiving surgical care in any setting. Risk of bias was assessed using two published checklists. Findings Thirty-two studies involving 24,043 participants were included. Most studies evaluated SSI prevention in orthopaedic surgeries. Antibiotic prophylaxis, screening, treating, or decolonization of meticillin-resistant Staphylococcus aureus and surgical wound closure were the main methods evaluated. Methods ranged from cost-analyses to cost-effectiveness and cost-utility analyses. Synthesis of results was not possible due to heterogeneity. All studies reported some economic benefit associated with preventing SSI; however, measures of benefit were not reported consistently and the quality of studies was low to moderate. Limited evidence in relation to SSI impact on quality of life was identified. Conclusion Current evidence in relation to the economic benefits of SSI prevention is limited. Further robust studies that utilize sound economic and epidemiological methods are required to inform future investment decisions in SSI prevention.

Background Few healthcare-associated infection (HAI) studies focus on risk of HAI at the point of admission. Understanding this will enable planning and management of care with infection prevention at the heart of the patient journey from the point of admission. Aim To determine intrinsic characteristics of patients at hospital admission and extrinsic events, during the two years preceding admission, that increase risk of developing HAI. Methods An incidence survey of adults within two hospitals in NHS Scotland was undertaken for one year in 2018/19 as part of the Evaluation of Cost of Nosocomial Infection (ECONI) study. The primary outcome measure was developing any HAI using recognized case definitions. The cohort was derived from routine hospital episode data and linkage to community dispensed prescribing data. Findings The risk factors present on admission observed as being the most significant for the acquisition of HAI were: being treated in a teaching hospital, increasing age, comorbidities of cancer, cardiovascular disease, chronic renal failure and diabetes; and emergency admission. Relative risk of developing HAI increased with intensive care unit, high-dependency unit, and surgical specialties, and surgery 30 days in the two years to admission. Conclusion Targeting patients at risk of HAI from the point of admission maximizes the potential for prevention, especially when extrinsic risk factors are known and managed. This study proposes a new approach to infection prevention and control (IPC), identifying those patients at greatest risk of developing a particular type of HAI who might be potential candidates for personalized IPC interventions.

Background Whereas the cost burden of healthcare-associated infection (HAI) extends beyond the inpatient stay into the post-discharge period, few studies have focused on post-discharge costs. Aim To investigate the impact of all types of HAI on the magnitude and distribution of post-discharge costs observed in acute and community services for patients who developed HAI during their inpatient stay. Methods Using data from the Evaluation of Cost of Nosocomial Infection (ECONI) study and regression methods, this study identifies the marginal effect of HAI on the 90-daypost-discharge resource use and costs. To calculate monetary values, unit costs were applied to estimates of excess resource use per case of HAI. Findings Post-discharge costs increase inpatient HAI costs by 36%, with an annual national cost of £10,832,437. The total extra cost per patient with HAI was £1,457 (95% confidence interval: 1,004–4,244) in the 90 days post discharge. Patients with HAI had longer LOS if they were readmitted and were prescribed more antibiotics in the community. The results suggest that HAI did not have an impact on the number of readmissions or repeat surgeries within 90 days of discharge. The majority (95%) of the excess costs was on acute care services after readmission. Bloodstream infection, gastrointestinal infection, and pneumonia had the biggest impact on post-discharge cost. Conclusion HAI increases costs and antibiotic consumption in the post-discharge period. Economic evaluations of IPC studies should incorporate post-discharge costs. These findings can be used nationally and internationally to support decision-making on the impact of IPC interventions.

Background Urinary incontinence is prevalent in nursing and residential care homes, and has a profound impact on residents’ dignity and quality of life. Treatment options are limited in these care contexts and care homes predominantly use absorbent pads to contain incontinence, rather than actively treat it. Transcutaneous posterior tibial nerve stimulation is a non-invasive, safe, low-cost intervention that is effective in reducing urinary incontinence in adults. Objective To determine the clinical effectiveness of transcutaneous posterior tibial nerve stimulation to treat urinary incontinence in care home residents and to determine the associated costs of the treatment. Design A multicentre, pragmatic, participant and outcome assessor-blind, randomised placebo-controlled trial. Setting A total of 37 UK residential and nursing care homes. Participants Care home residents with at least weekly urinary incontinence that is contained using absorbent pads and who are able to use a toilet/toilet aid with or without assistance. Interventions Residents were randomised (1 : 1) to receive 12 30-minute sessions of transcutaneous posterior tibial nerve stimulation or sham stimulation over a 6-week period. Main outcome measures Primary outcome – change in volume of urine leaked over a 24-hour period at 6 weeks. Secondary outcomes – number of pads used, Perception of Bladder Condition, toileting skills, quality of life and resource use. Results A total of 408 residents were randomised (transcutaneous posterior tibial nerve stimulation, n = 197; sham stimulation, n = 209); two exclusions occurred post randomisation. Primary outcome data were available for 345 (85%) residents (transcutaneous posterior tibial nerve stimulation, n = 167; sham stimulation, n = 178). Adherence to the intervention protocol was as follows: 78% of the transcutaneous posterior tibial nerve stimulation group and 71% of the sham group received the correct stimulation. Primary intention-to-treat adjusted analysis indicated a mean change of –5 ml (standard deviation 362 ml) urine leakage from baseline in the transcutaneous posterior tibial nerve stimulation group and –66 ml (standard deviation 394 ml) urine leakage in the sham group, which was a statistically significant, but not clinically important, between-group difference of 68-ml urine leakage (95% confidence interval 0 to 136 ml; p = 0.05) in favour of the sham group. Sensitivity analysis supported the primary analysis. No meaningful differences were detected in any of the secondary outcomes. No serious adverse events related to transcutaneous posterior tibial nerve stimulation were reported. Economic evaluation assessed the resources used. The training and support costs for the staff to deliver the intervention were estimated at £121.03 per staff member. Estimated costs for delivery of transcutaneous posterior tibial nerve stimulation during the trial were £81.20 per participant. No significant difference was found between participants’ scores over time, or between transcutaneous posterior tibial nerve stimulation and sham groups at any time point, for resident or proxy quality-of-life measures. Conclusions The ELECTRIC (ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes) trial showed, in the care home context (with a high proportion of residents with poor cognitive capacity and limited independent mobility), that transcutaneous posterior tibial nerve stimulation was not effective in reducing urinary incontinence. No economic case for transcutaneous posterior tibial nerve stimulation was made by the cost–consequences analysis; however, the positive reception of learning about urinary incontinence for care home staff supports a case for routine education in this care context. Limitations Completing 24-hour pad collections was challenging for care home staff, resulting in some missing primary outcome data. Future work Research should investigate transcutaneous posterior tibial nerve stimulation in residents with urgency urinary incontinence to determine whether or not targeted stimulation is effective. Research should evaluate the effects of continence training for staff on continence care in care homes. Trial registration Current Controlled Trials ISRCTN98415244 and ClinicalTrials.gov NCT03248362. 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. 25, No. 41. See the NIHR Journals Library website for further project information.

Background Men’s health is a globally underrepresented area of research and policy. With men facing numerous healthcare barriers, there are calls for more ‘male friendly’ approaches to health improvement that take into consideration differing male behaviours and attitudes towards health. Men’s Sheds are community-based organisations delivering practical and social activities that encourage positive health behaviours. While Sheds have been recognised for their health and wellbeing benefits to men, research has yet to explore the impacts of Sheds on male health improvement and their potential role as a preventative gendered public health measure. Methods The study used in-depth interviews with 62 Shed members from five Sheds to investigate the impacts of Shed activity on the health improvement behaviours and attitudes of Shed users. Findings from the qualitative study were used to propose a set of pathways in which Sheds activity led to positive health engagement. Results The proposed pathways suggest that there are many different and interlinked ways in which Shed activities can impact on the health behaviours and attitudes of Shed users. Through participation in various practical and social activities in an inclusive environment, Shed users reported increases in their health seeking behaviours, improved perspectives on and management of their personal health, and an increased ability to overcome illness and recover. Conclusions Where male friendly health provision has been lacking, this study suggests how Men’s Shed activities can provide positive male health outcomes, often in unexpected and non-obvious ways. In particular, the proposed visual pathways are important to inform policymakers and practitioners of the ways in that Sheds may contribute to engaging men in health improvement practices and increase their health knowledge. This study also provides a structure from which further studies can measure and evaluate Shed health impacts.

Background Pelvic organ prolapse is estimated to affect 41–50% of women aged > 40 years. A multicentre randomised controlled trial of individualised pelvic floor muscle training found that pelvic floor muscle training was effective in reducing symptoms of prolapse, improved quality of life and showed clear potential to be cost-effective. Provision of pelvic floor muscle training for prolapse has continued to vary across the UK, with limited availability of specialist physiotherapists to deliver it. Objectives This project aimed to study the implementation and outcomes of different models of delivery to increase the service provision of pelvic floor muscle training, and to follow up treatment outcomes for the original trial participants. Design A realist evaluation of pelvic floor muscle training implementation conducted within three full case study sites and two partial case study sites; an observational prospective cohort study comparing patient-reported outcomes pre and post intervention in all five sites; and a long-term follow-up study linking previous trial participants to routine NHS hospital data. Setting The setting for the realist evaluation was pelvic floor muscle training service delivery models in three NHS sites. The setting for the patient-reported outcome measures study was pelvic floor muscle training services in five NHS sites. Methods Realist evaluation qualitative data were collected at four time points in three case study sites to understand the implementation models, uptake, adherence and impact. Interviews involved service managers/leads, consultants, staff delivering pelvic floor muscle training and women receiving pelvic floor muscle training. Main outcomes measures Patient-reported outcomes were collected at baseline and at 6 and 12 months across five sites, including the Pelvic Organ Prolapse Symptom Score, health-related quality of life (measured using the EuroQol-5 Dimensions, five-level version, questionnaire), prolapse severity (measured using the Pelvic Organ Prolapse Quantification System), urinary incontinence (measured using International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form) and need for further treatment. Results A total of 102 women were recruited to the patient-reported outcome measures cohort study (target, n = 120), and 65 women had matched baseline and 6-month Pelvic Organ Prolapse Symptom Scores. The mean Pelvic Organ Prolapse Symptom Score was 10.18 (standard deviation 5.63) at baseline and 6.98 (standard deviation 5.23) at 6 months, representing a statistically significant and clinically meaningful difference. There was no statistically significant difference between the outcomes obtained from delivery by specialist physiotherapists and the outcomes obtained from delivery by other health-care professionals (mean change in Pelvic Organ Prolapse Symptom Score: –3.95 vs. –2.81, respectively). Services delivered using higher-band physiotherapists only were more costly than services delivered using other staff mixes. The effect of the original pelvic floor muscle training intervention, over a post-intervention period of > 10 years, was a reduction in the odds of any treatment during follow-up (odds ratio 0.61, 95% confidence interval 0.37 to 0.99). The realist evaluation revealed stark differences in implementation. The site with a specialist physiotherapy service resisted change because of perceived threats to the specialist role and concerns about care quality. Pelvic floor muscle training delivery by other health-care staff was easier when there was a lack of any existing specialist service; staff had prior training and interest in pelvic health; staff had support, autonomy, time and resources to deliver pelvic floor muscle training as part of their core role; and surrounding services supported a flow of pelvic floor muscle training referrals. Limitations The number of available matched pre and post outcomes for women and the lack of Pelvic Organ Prolapse Quantification System examinations were limitations of this study. Conclusions It is possible to train different staff to effectively deliver pelvic floor muscle training to women. Women’s self-reported outcomes significantly improved across all service models. Training should be adequately tailored to differential skill mix needs. Future work Future work should include further implementation of pelvic floor muscle training and should include pre- and post-outcome data collection using the Pelvic Organ Prolapse Symptom Score. Study registration This study is registered as Research Registry 4919. Funding This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 47. See the NIHR Journals Library website for further project information.

Background Increased length of stay (LOS) for patients is an important measure of the burden of healthcare-associated infection (HAI). Aim To estimate the excess LOS attributable to HAI. Methods This was a one-year prospective incidence study of HAI observed in one teaching hospital and one general hospital in NHS Scotland as part of the Evaluation of Cost of Nosocomial Infection (ECONI) study. All adult inpatients with an overnight stay were included. HAI was diagnosed using European Centres for Disease Prevention and Control definitions. A multi-state model was used to account for the time-varying nature of HAI and the competing risks of death and discharge. Findings The excess LOS attributable to HAI was 7.8 days (95% confidence interval (CI): 5.7–9.9). Median LOS for HAI patients was 30 days and for non-HAI patients was 3 days. Using a simple comparison of duration of hospital stay for HAI cases and non-cases would overestimate the excess LOS by 3.5 times (27 days compared with 7.8 days). The greatest impact on LOS was due to pneumonia (16.3 days; 95% CI: 7.5–25.2), bloodstream infections (11.4 days; 5.8–17.0) and surgical site infection (SSI) (9.8 days; 4.5–15.0). It is estimated that 58,000 bed-days are occupied due to HAI annually. Conclusion A reduction of 10% in HAI incidence could make 5800 bed-days available. These could be used to treat 1706 elective patients in Scotland annually and help reduce the number of patients awaiting planned treatment. This study has important implications for investment decisions in infection prevention and control interventions locally, nationally, and internationally.

Background Great Strides is a brief psychologically informed gait rehabilitation intervention (two compulsory face-to-face sessions and up to four optional sessions delivered over 3 months) aimed at improving lower limb function for adults with early rheumatoid arthritis (RA). As part of the Gait Rehabilitation in Early Arthritis Trial (GREAT) feasibility study, physiotherapists and podiatrists received two days of bespoke training delivered by psychologists, physiotherapists and podiatrists on i) the gait rehabilitation exercise programme (six walking exercises) ii) aspects of motivational interviewing (MI) and iii) delivery of key behaviour change techniques (BCTs) to facilitate motivation and adherence to the Great Strides intervention. The training was supported by a bespoke therapist manual and session checklists. The aim of this study was to explore therapists’ acceptability of: (1) the bespoke training received and (2) delivering the intervention within the GREAT feasibility study. Methods All 10 therapists who received training were invited to complete semi-structured interviews. The topic guide was informed by the Theoretical Framework of Acceptability (TFA). Interviews were audio recorded, professionally transcribed and a deductive thematic analysis was applied. Data were coded into six TFA constructs (Affective Attitude; Burden; Intervention Coherence; Opportunity Costs; Perceived Effectiveness; Self-efficacy). Results Nine out of ten therapists (four physiotherapists, five podiatrists) participated in the semi-structured interviews. Five therapists (four physiotherapists, one podiatrist) delivered the Great Strides intervention. Key barriers and enablers with regards to the acceptability of the bespoke training and intervention delivery were identified. Training: Therapists liked the supportive training environment (affective attitude), understood the purpose of the training sessions (intervention coherence), reported that the role play exercises aided their confidence in applying MI and BCTs (self-efficacy) and found that the training sessions were vital preparation for delivering the intervention (perceived effectiveness). Aspects of training which were considered unacceptable included the lack of time to attend the training sessions (opportunity costs). Delivery: All therapists enjoyed applying MI and BCTs to encourage participants to complete the gait exercises (affective attitude) and valued the opportunity to provide individualised care (intervention coherence). Barriers associated with acceptability included the use of trial-related materials (e.g. checklist) during intervention delivery (burden), interference of intervention delivery with routine clinical workload (opportunity costs) and the time delay between receiving training and initial intervention delivery (perceived effectiveness). Conclusion Both GREAT intervention training and delivery were considered acceptable to most therapists. The results have guided key refinements for training and intervention delivery for the GREAT internal pilot and full trial (e.g. remote access to training, timing of training in relation to intervention delivery). These refinements have the potential to improve the bespoke training and enhance the delivery of the Great Strides intervention maximising efficiency and potential for effectiveness. Disclosures M. Sekhon None. E. Godfrey None. G. Hendry None. N.E. Foster None. S. Hider None. M. van der Leeden None. H. Mason None. A. McConnachie None. I. McInnes None. A. Patience None. C. Sackley None. M. Steultjens None. A. Williams None. J. Woodburn None. L. Bearne None.

Background Foot pain, a hallmark feature of rheumatoid arthritis (RA), is associated with slow and unsteady gait patterns, and persistent walking disability is common. Great Strides is a new gait rehabilitation programme designed to improve/preserve lower limb function in early RA. It is delivered by physiotherapists or podiatrists over 12-weeks and is supplemented with a home programme and support materials (DVD and illustrated booklet). It consists of a 6-task gait circuit and is underpinned by behaviour change techniques driven by motivational interviewing. The aims of this feasibility study were to 1) evaluate patient acceptability, adherence to, and safety of Great Strides, and 2) identify a suitable primary outcome measure for the main trial. Methods This study was a multi-centre (n = 3), single arm, repeated measures (pre- and post-intervention) design, with interviews exploring participants’ intervention perceptions. People with early ( Results 35 participants (68.6% female) with median age (inter-quartile range [IQR]) 60 [49-68] years and disease duration 9 [4-16] months), were recruited over 9 months and 23 (67%) completed 12-week follow-up. 12 participants completed interviews after the 12-week intervention period. Intervention acceptability was excellent; 21/23 were confident that it could help the problem; 21/23 reported that they would recommend it to a friend; 22/23 indicated it made sense to them. Intervention adherence was moderate, with a median [IQR] EARS score of 12/24 [7-19]. 1 participant reported transient post-exercise soreness. No serious adverse events were reported that were related to the intervention. From interviews, 10/12 participants reported they had continued with the intervention after 12-weeks. Participants revealed that the intervention provided structure and control to their day/week. Additional perceptions of benefit reported included improvements to lower limb joint health, and feelings of increased confidence to return to, or progress to further exercise in the community. The main challenge identified by some participants was lack of space to do the intervention at home. Correlations with the CWA were better for FFI-DS change-scores. Conclusion Great Strides has excellent acceptability and appears safe for people with early RA. Levels of adherence may be improved by intervention refinement. FFI-DS scores were theoretically consistent for selection as primary outcome for the main trial. Disclosures G.J. Hendry None. L. Bearne None. N. Foster None. E. Godfrey None. S. Hider None. M. van der Leeden None. H. Mason None. A. McConnachie None. I. McInnes None. A. Patience None. C. Sackley None. M. Sekhon None. A. Williams None. J. Woodburn None. M. Steultjens None.

IntroductionParkinson’s disease is the second most common chronic neurodegenerative condition with bladder dysfunction affecting up to 71%. Symptoms affect quality of life and include urgency, frequency, hesitancy, nocturia and incontinence. Addressing urinary dysfunction is one of the top 10 priority research areas identified by the James Lind Alliance and Parkinson’s UK.ObjectivesConduct a randomised controlled trial (RCT) targeting people with Parkinson’s disease (PwP) who have self-reported problematic lower urinary tract symptoms, investigating the effectiveness of transcutaneous tibial nerve stimulation (TTNS) compared with sham TTNS. Implement a standardised training approach and package for the correct application of TTNS. Conduct a cost-effectiveness analysis of TTNS compared with sham TTNS.Methods and analysisAn RCT of 6 weeks with twice weekly TTNS or sham TTNS. Participants will be recruited in 12 National Health Service neurology/movement disorder services, using a web-based randomisation system, and will be shown how to apply TTNS or sham TTNS. Participants will receive a weekly telephone call from the researchers during the intervention period. The trial has two coprimary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score. Secondary outcomes include a 3-day bladder diary, quality of life, acceptability and fidelity and health economic evaluation. Outcomes will be measured at 0, 6 and 12 weeks.A sample size of 208 randomised in equal numbers to the two arms will provide 90% power to detect a clinically important difference of 2.52 points on the Internatioanl Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and of 3 points in the International Prostate Symptom Score total score at 12 weeks at 5% significance level, based on an SD of 4.7 in each arm and 20% attrition at 6 weeks. Analysis will be by intention to treat and pre defined in a statistical analysis planEthics and disseminationEast of Scotland Research Ethics Service (EoSRES), 18/ES00042, obtained on 10 May 2018. The trial will allow us to determine effectiveness, safety, cost and acceptability of TTNS for bladder dysfunction in PWP. Results will be published in open access journals; lay reports will be posted to all participants and presented at conferences.Trial registration numberISRCTN12437878; Pre-results.

Background Urinary incontinence (UI) is highly prevalent in nursing and residential care homes (CHs) and profoundly impacts on residents’ dignity and quality of life. CHs predominantly use absorbent pads to contain UI rather than actively treat the condition. Transcutaneous posterior tibial nerve stimulation (TPTNS) is a non-invasive, safe and low-cost intervention with demonstrated effectiveness for reducing UI in adults. However, the effectiveness of TPTNS to treat UI in older adults living in CHs is not known. The ELECTRIC trial aims to establish if a programme of TPTNS is a clinically effective treatment for UI in CH residents and investigate the associated costs and consequences. Methods This is a pragmatic, multicentre, placebo-controlled, randomised parallel-group trial comparing the effectiveness of TPTNS (target n = 250) with sham stimulation (target n = 250) in reducing volume of UI in CH residents. CH residents (men and women) with self- or staff-reported UI of more than once per week are eligible to take part, including those with cognitive impairment. Outcomes will be measured at 6, 12 and 18 weeks post randomisation using the following measures: 24-h Pad Weight Tests, post void residual urine (bladder scans), Patient Perception of Bladder Condition, Minnesota Toileting Skills Questionnaire and Dementia Quality of Life. Economic evaluation based on a bespoke Resource Use Questionnaire will assess the costs of providing a programme of TPTNS. A concurrent process evaluation will investigate fidelity to the intervention and influencing factors, and qualitative interviews will explore the experiences of TPTNS from the perspective of CH residents, family members, CH staff and managers. Discussion TPTNS is a non-invasive intervention that has demonstrated effectiveness in reducing UI in adults. The ELECTRIC trial will involve CH staff delivering TPTNS to residents and establish whether TPTNS is more effective than sham stimulation for reducing the volume of UI in CH residents. Should TPTNS be shown to be an effective and acceptable treatment for UI in older adults in CHs, it will provide a safe, low-cost and dignified alternative to the current standard approach of containment and medication. Trial registration ClinicalTrials.gov, NCT03248362. Registered on 14 August 2017. ISRCTN, ISRCTN98415244. Registered on 25 April 2018. https://www.isrctn.com/.

IntroductionHealthcare-associated or nosocomial infection (HAI) is distressing to patients and costly for the National Health Service (NHS). With increasing pressure to demonstrate cost-effectiveness of interventions to control HAI and notwithstanding the risk from antimicrobial-resistant infections, there is a need to understand the incidence rates of HAI and costs incurred by the health system and for patients themselves.Methods and analysisThe Evaluation of Cost of Nosocomial Infection study (ECONI) is an observational incidence survey with record linkage and a nested case-control study that will include postdischarge longitudinal follow-up and qualitative interviews. ECONI will be conducted in one large teaching hospital and one district general hospital in NHS Scotland. The case mix of these hospitals reflects the majority of overnight admissions within Scotland. An incidence survey will record all HAI cases using standard case definitions. Subsequent linkage to routine data sets will provide information on an admission cohort which will be grouped into HAI and non-HAI cases. The case-control study will recruit eligible patients who develop HAI and twice that number without HAI as controls. Patients will be asked to complete five questionnaires: the first during their stay, and four others during the year following discharge from their recruitment admission (1, 3, 6 and 12 months). Multiple data collection methods will include clinical case note review; patient-reported outcome; linkage to electronic health records and qualitative interviews. Outcomes collected encompass infection types; morbidity and mortality; length of stay; quality of life; healthcare utilisation; repeat admissions and postdischarge prescribing.Ethics and disseminationThe study has received a favourable ethical opinion from the Scotland A Research Ethics Committee (reference 16/SS/0199). All publications arising from this study will be published in open-access peer-reviewed journal. Lay-person summaries will be published on the ECONI website.Trial registration numberNCT03253640; Pre-results.

Background Multimorbidity is prevalent and adversely affects health outcomes. Foot pain is common and one of the primary reasons for utilisation of podiatry services. At present, little is known about the impact of multimorbidity on foot health and related outcomes following podiatric intervention. The aims of this study were to evaluate whether there is a difference in foot health outcomes following exposure to podiatric foot care for people with and without multimorbidity; and ii) to evaluate whether the presence or absence of multimorbidity affects patients’ perceptions of change in foot pain. Methods The PROMFoot study is a prospective cohort study of adults with a new episode of foot pain attending the podiatry service within the NHS Greater Glasgow and Clyde health board. Baseline medical comorbidity status (no condition, single condition, multiple conditions), longitudinal data on foot health measured using the Foot Health Status Questionnaire (FHSQ), and patient rating of change scores for foot pain were obtained from the PROMFoot study at baseline, and 3 and 6 months after podiatric intervention. Foot health scores (pain, function, footwear and general foot health) and perceptions of change for foot pain were compared between comorbidity groups. Results A total of 115 participants (59% female) with a mean age of 55 years were included. Multimorbidity was common, affecting 61 participants (53%); while 28 (24.3%) and 26 (22.6%) reported single or no medical comorbidities respectively. Significantly worse foot health scores for all FHSQ domains were observed for the multimorbidity group at baseline, 3 and 6 months. Change scores for foot pain were similar between groups and demonstrate modest improvements, however multimorbidity group membership was strongly associated with a perceptions of change in foot pain. Multimorbidity was independently associated with poorer foot function outcomes at 3 months, and poorer foot pain and foot function outcomes at 6 months. Conclusions Multimorbidity was associated with poor foot health outcomes and lower rates of self-perceived improvement in foot pain over 6 months following podiatric intervention in a sample of patients attending podiatric biomechanics clinics for a new episode of foot pain. Electronic supplementary material The online version of this article (10.1186/s13047-019-0346-x) contains supplementary material, which is available to authorized users.

BackgroundColorectal cancer (CRC) survivors are not meeting the recommended physical activity levels associated with improving their chances of survival and quality of life. Rehabilitation could address this problem.ObjectivesThe aims of the Cardiac Rehabilitation In Bowel cancer study were to assess whether or not cardiac rehabilitation is a feasible and acceptable model to aid the recovery of people with CRC and to test the feasibility and acceptability of the protocol design.DesignIntervention testing and feasibility work (phase 1) and a pilot randomised controlled trial with embedded qualitative study (phase 2), supplemented with an economic evaluation. Randomisation was to cardiac rehabilitation or usual care. Outcomes were differences in objective measures of physical activity and sedentary behaviour, self-reported measures of quality of life, anxiety, depression and fatigue. Qualitative work involved patients and clinicians from both cancer and cardiac specialties.SettingThree colorectal cancer wards and three cardiac rehabilitation facilities.ParticipantsInclusion criteria were those who were aged > 18 years, had primary CRC and were post surgery.ResultsPhase 1 (single site) – of 34 patient admissions, 24 (70%) were eligible and 4 (17%) participated in cardiac rehabilitation. Sixteen clinicians participated in an interview/focus group. Modifications to trial procedures were made for further testing in phase 2. Additionally, 20 clinicians in all three sites were trained in cancer and exercise, rating it as excellent. Phase 2 (three sites) – screening, eligibility, consent and retention rates were 156 (79%), 133 (67%), 41 (31%) and 38 (93%), respectively. Questionnaire completion rates were 40 (97.5%), 31 (75%) and 25 (61%) at baseline, follow-up 1 and follow-up 2, respectively. Forty (69%) accelerometer data sets were analysed; 20 (31%) were removed owing to invalid data.Qualitative studyCRC and cardiac patients and clinicians were interviewed. Key themes were benefits and barriers for people with CRC attending cardiac rehabilitation; generic versus disease-specific rehabilitation; key concerns of the intervention; and barriers to participation (CRC participants only).Economic evaluationThe average out-of-pocket expenses of attending cardiac rehabilitation were £50. The costs of cardiac rehabilitation for people with cancer are highly dependent on whether it involves accommodating additional patients in an already existing service or setting up a completely new service.Limitations and conclusionsThe main limitation is that this is a small feasibility and pilot study. The main novel finding is that cardiac rehabilitation for cancer and cardiac patients together is feasible and acceptable, thereby challenging disease-specific rehabilitation models.Future workThis study highlighted important challenges to doing a full-scale trial of cardiac rehabilitation but does not, we believe, provide sufficient evidence to reject the possibility of such a future trial. We recommend that any future trial must specifically address the challenges identified in this study, such as suboptimal consent, completion, missing data and intervention adherence rates and recruitment bias, and that an internal pilot trial be conducted. This should have clear ‘stop–proceed’ rules that are formally reviewed before proceeding to the full-scale trial.Trial registrationCurrent Controlled Trials ISRCTN63510637.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full inHealth Services and Delivery Research; Vol. 4, No. 24. See the NIHR Journals Library website for further project information.

This paper describes a partnership project between three organisations, a UK-based charity who’s primary purpose is supporting children in war zones, Transcultural Psychosocial Organization Uganda and Animation Therapy Ltd, to deliver a training programme for staff working with hard-to-engage children in two refugee settlements in northern Uganda. It begins with an introduction to the current global refugee crisis, including the situation in Southern Africa. An account is given of how the creative partnership came about, and its purpose. The training project is described, highlighting the roles of the two occupational therapists involved. The paper ends with some lessons learned from the project and their implications for occupational therapy education and practice.

Background Between 50% and 80% of people with multiple sclerosis (PwMS) experience neurogenic bowel dysfunction (NBD) (i.e. constipation and faecal incontinence) that affects quality of life and can lead to hospitalisation. Objectives To determine the clinical effectiveness and cost-effectiveness of abdominal massage plus advice on bowel symptoms on PwMS compared with advice only. A process evaluation investigated the factors that affected the clinical effectiveness and possible implementation of the different treatments. Design A randomised controlled trial with process evaluation and health economic components. Outcome analysis was undertaken blind. Setting The trial took place in 12 UK hospitals. Participants PwMS who had ‘bothersome’ NBD. Intervention Following individualised training, abdominal massage was undertaken daily for 6 weeks (intervention group). Advice on good bowel management as per the Multiple Sclerosis Society advice booklet was provided to both groups. All participants received weekly telephone calls from the research nurse. Main outcome measures The primary outcome was the difference between the intervention and control groups in change in the NBD score from baseline to week 24. Secondary outcomes were measured via a bowel diary, adherence diary, the Constipation Scoring System, patient resource questionnaire and the EuroQol-5 Dimensions, five-level version (EQ-5D-5L). Results A total of 191 participants were finalised, 189 of whom were randomised (two participants were finalised in error) (control group, n = 99; intervention group, n = 90) and an intention-to-treat analysis was performed. The mean age was 52 years (standard deviation 10.83 years), 81% (n = 154) were female and 11% (n = 21) were wheelchair dependent. Fifteen participants from the intervention group and five from the control group were lost to follow-up. The change in NBD score by week 24 demonstrated no significant difference between groups [mean difference total score –1.64, 95% confidence interval (CI) –3.32 to 0.04; p = 0.0558]; there was a significant difference between groups in the change in the frequency of stool evacuation per week (mean difference 0.62, 95% CI 0.03 to 1.21; p = 0.039) and in the number of times per week that participants felt that they emptied their bowels completely (mean difference 1.08, 95% CI 0.41 to 1.76; p = 0.002), in favour of the intervention group. Of participant interviewees, 75% reported benefits, for example less difficulty passing stool, more complete evacuations, less bloated, improved appetite, and 85% continued with the massage. A cost–utility analysis conducted from a NHS and patient cost perspective found in the imputed sample with bootstrapping a mean incremental outcome effect of the intervention relative to usual care of –0.002 quality-adjusted life-years (QALYs) (95% CI –0.029 to 0.027 QALYs). In the same imputed sample with bootstrapping, the mean incremental cost effect of the intervention relative to usual care was £56.50 (95% CI –£372.62 to £415.68). No adverse events were reported. Limitations include unequal randomisation, dropout and the possibility of ineffective massage technique. Conclusion The increment in the primary outcome favoured the intervention group, but it was small and not statistically significant. The economic analysis identified that the intervention was dominated by the control group. Given the small improvement in the primary outcome, but not in terms of QALYs, a low-cost version of the intervention might be considered worthwhile by some patients. Future work Research is required to establish possible mechanisms of action and modes of massage delivery. Trial registration Current Controlled Trials ISRCTN85007023 and NCT03166007. Funding This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 58. See the NIHR Journals Library website for further project information.

Objective The aim was to appraise and synthesize studies evaluating the clinical and cost effectiveness of conservative interventions for chronic lower extremity musculoskeletal (MSK) conditions and describe their characteristics, including the type of economic evaluation, primary outcomes and which conditions. Methods The search strategy related to economic evaluations of lower limb MSK conditions that used conservative therapies. Eight electronic databases were searched (CENTRAL, MEDLINE, PubMed, EMBASE, CINAHL, PEDro, NHSEED and Proquest), as were the reference lists from included articles. The quality of articles was appraised using a modified version of the economic evaluations’ reporting checklist (economic) and The Cochrane Collaboration’s tool for assessing risk of bias (clinical). Results Twenty-six studies were eligible and included in the review. Economic evaluations of conservative interventions for OA or pain affecting the knee/hip (n = 25; 93%) were most common. The main approaches adopted were cost–utility analysis (n = 17; 68%) or cost–effectiveness analysis (n = 5; 19%). Two studies involved interventions including footwear/foot orthoses; for heel pain (n = 1; 4%) and overuse injuries (n = 1; 4%). Fifty per cent of economic evaluations adopted the EQ-5D-3L as the primary outcome measure for quality of life and quality-adjusted life year calculations. Conclusion Economic evaluations have been conducted largely for exercise-based interventions for MSK conditions of the hip and knee. Few economic evaluations have been conducted for other clinically important lower limb MSK conditions. A matrix presentation of costs mapped with outcomes indicated increasing costs with either no difference or improvements in clinical effectiveness. The majority of economic evaluations were of good reporting quality, as were the accompanying clinical studies.

Background Pelvic Organ Prolapse (POP) is estimated to affect 41%–50% of women aged over 40. Findings from the multi-centre randomised controlled “Pelvic Organ Prolapse PhysiotherapY” (POPPY) trial showed that individualised pelvic floor muscle training (PFMT) was effective in reducing symptoms of prolapse, improved quality of life and showed clear potential to be cost-effective. However, provision of PFMT for prolapse continues to vary across the UK, with limited numbers of women’s health physiotherapists specialising in its delivery. Implementation of this robust evidence from the POPPY trial will require attention to different models of delivery (e.g. staff skill mix) to fit with differing care environments. Methods A Realist Evaluation (RE) of implementation and outcomes of PFMT delivery in contrasting NHS settings will be conducted using multiple case study sites. Involving substantial local stakeholder engagement will permit a detailed exploration of how local sites make decisions on how to deliver PFMT and how these lead to service change. The RE will track how implementation is working; identify what influences outcomes; and, guided by the RE-AIM framework, will collect robust outcomes data. This will require mixed methods data collection and analysis. Qualitative data will be collected at four time-points across each site to understand local contexts and decisions regarding options for intervention delivery and to monitor implementation, uptake, adherence and outcomes. Patient outcome data will be collected at baseline, six months and one year follow-up for 120 women. Primary outcome will be the Pelvic Organ Prolapse Symptom Score (POP-SS). An economic evaluation will assess the costs and benefits associated with different delivery models taking account of further health care resource use by the women. Cost data will be combined with the primary outcome in a cost effectiveness analysis, and the EQ-5D-5L data in a cost utility analysis for each of the different models of delivery. Discussion Study of the implementation of varying models of service delivery of PFMT across contrasting sites combined with outcomes data and a cost effectiveness analysis will provide insight into the implementation and value of different models of PFMT service delivery and the cost benefits to the NHS in the longer term.

Background Multiple sclerosis (MS) is a life-long condition primarily affecting younger adults. Neurogenic bowel dysfunction (NBD) occurs in 50–80% of these patients and is the term used to describe constipation and faecal incontinence, which often co-exist. Data from a pilot study suggested feasibility of using abdominal massage for the relief of constipation, but the effectiveness remains uncertain. Methods/design This is a multi-centred patient randomised superiority trial comparing an experimental strategy of once daily abdominal massage for 6 weeks against a control strategy of no massage in people with MS who have stated that their constipation is bothersome. The primary outcome is the Neurogenic Bowel Dysfunction Score at 24 weeks. Both groups will receive optimised advice plus the MS Society booklet on bowel management in MS, and will continue to receive usual care. Participants and their clinicians will not be blinded to the allocated intervention. Outcome measures are primarily self-reported and submitted anonymously. Central trial staff who will manage and analyse the trial data will be unaware of participant allocations. Analysis will follow intention-to-treat principles. Discussion This pragmatic randomised controlled trial will demonstrate if abdominal massage is an effective, cost-effective and viable addition to the treatment of NBD in people with MS. Trial registration ClinicalTrials.gov, ISRCTN85007023. Registered on 10 June 2014. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1890-y) contains supplementary material, which is available to authorized users.

Objectives: Health care budgets are finite and decisions must be made about which interventions to provide and, by implication, which will not be provided. The aim of this study was to investigate what features of health care interventions, including the type of health gain, are important to members of the public in England in making priority-setting decisions and to understand why. Methods: Q methodology was used with 52 members of the public in north east England. Respondents rank ordered 36 health care interventions from those they would give highest priority to through to those they would give lowest priority to. A form of factor analysis was used to reveal a small number of shared viewpoints. Results: Five factors emerged: ‘life saving to maximize the size of the health gain’, ‘everyone deserves a chance at life’, ‘(potential for) own benefit’, ‘maximum benefit for (perceived) lowest cost’ and ‘quality of life and social responsibility’. There were different views about which interventions should be given priority. Respondents considered not only the type of health gain received from an intervention as important, but also the size of the health gain, who received the health gain and an individual's personal responsibility. Conclusions: Aspects other than health gain need to be considered when soliciting the public's views of priorities for health care interventions.

BackgroundPilot and feasibility work is conducted to evaluate the operational feasibility and acceptability of the intervention itself and the feasibility and acceptability of a trials’ protocol design. The Cardiac Rehabilitation In Bowel cancer (CRIB) study was a pilot randomised controlled trial (RCT) of cardiac rehabilitation versus usual care (no rehabilitation) for post-surgical colorectal cancer patients. A key aim of the pilot trial was to test the feasibility and acceptability of the protocol design.MethodsA pilot RCT with embedded qualitative work was conducted in three sites. Participants were randomly allocated to cardiac rehabilitation or usual care groups. Outcomes used to assess the feasibility and acceptability of key trial parameters were screening, eligibility, consent, randomisation, adverse events, retention, completion, missing data, and intervention adherence rates. Colorectal patients’ and clinicians’ perceptions and experiences of the main trial procedures were explored by interview.ResultsQuantitative study. Three sites were involved. Screening, eligibility, consent, and retention rates were 79 % (156/198), 67 % (133/198), 31 % (41/133), and 93 % (38/41), respectively. Questionnaire completion rates were 97.5 % (40/41), 75 % (31/41), and 61 % (25/41) at baseline, follow-up 1, and follow-up 2, respectively. Sixty-nine percent (40) of accelerometer datasets were collected from participants; 31 % (20) were removed for not meeting wear-time validation.Qualitative studyThirty-eight patients and eight clinicians participated. Key themes were benefits for people with colorectal cancer attending cardiac rehabilitation, barriers for people with colorectal cancer attending cardiac rehabilitation, generic versus disease-specific rehabilitation, key concerns about including people with cancer in cardiac rehabilitation, and barriers to involvement in a study about cardiac rehabilitation.ConclusionsThe study highlights where threats to internal and external validity are likely to arise in any future studies of similar structured physical activity interventions for colorectal cancer patients using similar methods being conducted in similar contexts. This study shows that there is likely to be potential recruitment bias and potential imprecision due to sub-optimal completion of outcome measures, missing data, and sub-optimal intervention adherence. Hence, strategies to manage these risks should be developed to stack the odds in favour of conducting successful future trials.

Background:Positron emission tomography (PET) and single photon emission computed tomography (SPECT) brain imaging are widely used as diagnostic tools for suspected dementia but no studies have directly compared participant views of the two procedures. We used a range of methods to explore preferences for PET and SPECT.Methods:Patients and controls (and accompanying carers) completed questionnaires immediately after undergoing PET and SPECT brain scans. Pulse rate data were collected during each scan. Scan attributes were prioritized using a card sorting exercise; carers and controls additionally answered willingness to pay (WTP) questions.Results:Few differences were found either between the scans or groups of participants, although carers marginally preferred SPECT. Diagnostic accuracy was prioritized over other scan characteristics. Mean heart rate during both scans was lower than baseline heart rate measured at home (p < 0.001).Conclusion:Most participants viewed PET and SPECT scans as roughly equivalent and did not have a preference for either scan. Carer preference for SPECT is likely to reflect their desire to be with the patient (routine practice for SPECT but not for PET), suggesting that they should be able to accompany vulnerable patients throughout imaging procedures wherever possible. Pulse rate data indicated that brain imaging was no more stressful than a home visit (HV) from a researcher. The data do not support the anecdotal view that PET is a more burdensome procedure and the use of PET or SPECT scans in dementia should be based on diagnostic accuracy of the technique.

Background Middle income countries are facing an epidemic of non-communicable diseases, especially coronary heart disease (CHD). We used a validated CHD mortality model (IMPACT) to explain recent trends in Tunisia, Syria, the occupied Palestinian territory (oPt) and Turkey. Methods Data on populations, mortality, patient numbers, treatments and risk factor trends from national and local surveys in each country were collated over two time points (1995-97; 2006-09); integrated and analysed using the IMPACT model. Results Risk factor trends: Smoking prevalence was high in men, persisting in Syria but decreasing in Tunisia, oPt and Turkey. BMI rose by 1-2 kg/m2 and diabetes prevalence increased by 40%-50%. Mean systolic blood pressure and cholesterol levels increased in Tunisia and Syria. Mortality trends: Age-standardised CHD mortality rates rose by 20% in Tunisia and 62% in Syria. Much of this increase (79% and 72% respectively) was attributed to adverse trends in major risk factors, occurring despite some improvements in treatment uptake. CHD mortality rates fell by 17% in oPt and by 25% in Turkey, with risk factor changes accounting for around 46% and 30% of this reduction respectively. Increased uptake of community treatments (drug treatments for chronic angina, heart failure, hypertension and secondary prevention after a cardiac event) accounted for most of the remainder. Discussion CHD death rates are rising in Tunisia and Syria, whilst oPt and Turkey demonstrate clear falls, reflecting improvements in major risk factors with contributions from medical treatments. However, smoking prevalence remains very high in men; obesity and diabetes levels are rising dramatically. The MedCHAMPS project and data collection were funded by EC FP7 grant no. 223705 . JC and SC are supported by the UK Higher Education Funding Council . MOF was partly funded by the European Union and the UK Medical Research Council ( NPR3, Project 45 ). This study was funded by the European Community's Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 223075 - the MedCHAMPS project. MOF was also supported by the UK MRC . Scopus

Objective To investigate the possibility of direct effects of metformin on ovarian steroidogenesis. Design Cultured ovarian cells. Setting Academic research environment. Patient(s) Women undergoing bilateral salpingoophorectomy for benign gynecological disease. Main outcome measure(s) Estradiol and P were measured in granulosa cell (GC) conditioned medium and androstenedione (A) and P in theca conditioned medium. Result(s) The effect of addition of metformin alone to GCs was variable, but significant inhibition of both P and E 2 was seen (range 0%–30%). Metformin dose-dependently inhibited gonadotrophin and insulin -stimulated P and E 2 production (range 25%–50%). In theca, metformin inhibited A production (0%–40%) with no effect on P. In the presence of insulin, A was inhibited dose-dependently and P increased by a similar magnitude. Conclusion(s) These results demonstrate a direct effect of metformin on ovarian steroidogenesis. The inhibitory effects on androgen production in particular would be beneficial in polycystic ovary syndrome (PCOS).

The ovarian insulin-like growth factor (IGF)/IGF binding protein (IGFBP) system operates to permit maximal stimulation of steroidogenesis in the dominant follicle. In atretic follicles, the predominant IGFBPs are IGFBP-2 and IGFBP-4, which appear to be selectively cleaved in healthy follicles. We have recently demonstrated potent inhibition by IGFBP-4 of both theca and granulosa cell steroid production. The degree to which the inhibition occurred suggested that it was greater than might be expected by sequestration of IGF alone. Our study was designed to test this idea. Granulosa cells were harvested from follicles dissected intact from patients undergoing total abdominal hysterectomy and bilateral salpingoophorectomy. Granulosa cells were incubated with or without gonadotropins and IGFBP-4 in the presence or absence of either the IGF type I receptor blocker αIR3 or excess IGFBP-3 to remove the effects of endogenous IGF action. Steroid accumulation in the medium was assessed. IGFBP-4 continued to exert potent inhibitory effects when the action of endogenous IGF was removed from the system, demonstrating that its actions are independent of IGF binding. There was no effect on cell metabolism, and the effects on steroidogenesis were reversible after IGFBP-4 removal from the culture medium. No similar effects were seen with IGFBP-2. These reasults are the first evidence of IGF-independent IGFBP-4 actions and the first evidence of IGF-independent actions of any IGFBPs in the ovary.

Objective To determine the optimal weight-to-height ratio to achieve maturity of the reproductive organs when visualized by pelvic ultrasound in adolescent girls with anorexia nervosa. To examine the distribution of weight-to-height ratios in the group of adolescents in whom pelvic maturity was attained. Methods Adolescent girls with anorexia nervosa received serial transabdominal pelvic ultrasound scans as they regained weight. A record of their weight-to-height ratio had been noted on each occasion. The scans were defined as mature or immature using strict criteria. Results There was a wide range of weight-to-height ratios in both the mature and immature groups of patients with a considerable overlap between the groups. However, 88% of the sample required a weight-to-height ratio of 100% (body mass index [BMI] 20) to achieve reproductive maturity. Conclusion Previous target weights have been too low to ensure reproductive maturity. The resulting hypoestrogenic state increases the risk of future osteoporosis. Pelvic ultrasound is the safest and most reliable method for determining ovarian and uterine maturity in adolescent girls with anorexia nervosa. © 2002 by Wiley Periodicals, Inc. Int J Eat Disord 32: 319–325, 2002.

The key drivers of population health lie outside the health sector. However, decision makers outside the health sector are primarily interested in delivering sector specific outputs other than health. Economic approaches to priority setting can help align sectors to consider the intersectoral impacts of decisions within an integrated societal framework. First, economic evaluation can explicitly identify and measure all impacts – including health – and value them as inputs into overall social welfare. Second, priority setting tools such as program budgeting marginal analysis and multi-criteria decision analysis can then be used to help translate evidence into policy, where the full consequences of decisions are considered and the overall aim is to improve social welfare.

The mechanism of the increase in the number of follicles in polycystic ovaries (PCO) is still not understood, but most data indicate that folliculogenesis is abnormal at all stages. This increase is probably due to prolonged follicle growth in both ovulatory (ov) and anovulatory PCO (anovPCO) rather than over-recruitment from the primordial stage. There appear to be fewer follicles in ovPCO than in anovPCO and this may be due to slow growth combined with arrested development in the anovPCO, preventing the normal process of atresia. This idea is supported by data indicating that the preponderance of structures in anovPCO are functional follicles rather than atretic cysts. In contrast, follicles in ovPCO are primarily atretic, analogous to the situation in the normal ovary. Closer analysis of the function of these follicles reveals an intrinsic defect in the theca cell layer in the expression of the genes encoding steroidogenic enzymes. Although androgen production is increased in all PCOs, the serum concentrations of androgen tended to be higher in anovulatory women indicating that there may be a link between the ovarian concentration and anovulation. Granulosa cells in small follicles from anovPCO behave in a similar fashion to those in preovulatory follicles from normal ovaries in terms of steroidogenic responses. This, in combination with the finding of LH-responsiveness in small follicles from anovPCO, has led to the suggestion that these follicles are prematurely luteinized. The recent finding that follistatin gene regulation may be abnormal in women with polycystic ovary syndrome (PCOS) provides a new insight into the possible defect in the function of these ovaries. Elucidation of the precise nature of the defect may provide the key to understanding the apparent contradiction of increased steroidogenesis in the presence of abnormal and arrested follicle growth.

Aims: To measure the prevalence, pattern and associated financial cost of alcohol-related ambulance call outs in the North East of England using routinely collected data from the North East Ambulance Service (NEAS). Methods: A retrospective cohort study over a 1-year time period (1 April 2009 to 31 March 2010) using NEAS patient record forms. Results: In the North East, 10% of ambulance call outs were alcohol-related. Males were 2.5 times more likely than females to be attended by an ambu- lance on the street rather than at home. People aged 10-19 had the highest relative risk ratio (3.4) of an ambulance pick up being on the street compare with those aged over 60. These call outs and subsequent accident and emergency (A&E) attendances cost over £9 million in a 1-year period. When extrapolated to the whole country the cost could be as much as £152 million per year. Conclusion: In a 1-year period, we estimated that over 31,000 ambulance call outs were alcohol-related. A large discrepancy was found between manual and electronic recording of alcohol-related ambulance attendances to A&E. The workload and cost of alcohol-related call outs is high and mostly preventable. Ambulance visits may present a teachable moment for brief intervention to reduce alcohol- related risk and harm.

Olaparib is an oral inhibitor of the Poly-(ADP-ribose)-polymerases (PARP-1, -2 and -3), and has demonstrated clinical activity in trials of patients with BRCA-deficient tumors. The BRCA1 and BRCA2 proteins are both important for the repair of DNA double strand breaks (DSBs) by homologous recombination repair (HRR) and sensitivity to olaparib has further been shown preclinically to extend to other DNA DSB repair factor deficiencies, including those in the ataxia telangiectasia mutated (ATM) protein. We have demonstrated that a high proportion of gastric cancer (GC) cell lines (∼50%) are responsive (IC50 Based on these data, a Phase II GC trial has been carried out that enriches for patients with tumors having low or undetectable ATM IHC scores (H-score equivalent less than or equal to 10). Data from this clinical trial confirm activity (overall survival [OS] benefit HR=0.56, 95% CI: 0.35-0.87; P=0.010) in the overall population, which includes ATM tumor positive patients, and importantly, a substantially better OS benefit in the ATM-negative population (HR=0.35, 95% CI: 0.17-0.71; P=0.003). Together, these data provide an important example of a PARP inhibitor demonstrating both preclinical and clinical activity in a well defined but non-BRCA DNA repair deficient background. Citation Format: Darren Hodgson, Helen Mason, Lenka Oplustilova, Chris Harbron, Xiaolu Yin, Seock-Ah Im, Helen Jones, Lai Zhongwu, Brian Dougherty, Matthew McLoughlin, James Bradford, Andrew Dickinson, Anitra Fielding, Jane Robertson, Woo-Ho Kim, Chris Womack, Yi Gu, Yung-Jue Bang, Alan Lau, J. Carl Barrett, Mark J. O'Connor. Activity of the PARP inhibitor olaparib in ATM-deficient gastric cancer: from preclinical models to the clinic. [abstract]. In: Proceedings of the 105th Annual Meeting of the American Association for Cancer Research; 2014 Apr 5-9; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2014;74(19 Suppl):Abstract nr 2398. doi:10.1158/1538-7445.AM2014-2398

Introduction: Patients with colorectal cancer report ongoing physical and psychological impairments and a high proportion of these patients are overweight, insufficiently active and high-risk drinkers, putting them at risk of poor recovery and risk of recurrence and comorbidities. A challenge is implementing sustainable and effective rehabilitation as part of routine care for this group.\ud \ud Methods and analysis: A two-arm pilot randomised controlled trial (RCT) with embedded feasibility study undertaken as a phased programme of work. The intervention involves an existing cardiac rehabilitation programme for cardiac patients accepting colorectal cancer patient referrals. The intervention consists of supervised exercise sessions run by a cardiac physiotherapist and information sessions. Phase 1 will involve one research site enrolling 12 patients to assess intervention and study design processes. Semistructured interviews with patients with colorectal cancer and cardiac patients and clinicians will be used to gather data on acceptability of the intervention and study procedures. Phase 2 will involve three sites enrolling 66 patients with colorectal cancer randomised to control or intervention groups. Outcome measures will be taken preintervention and postintervention, for phases 1 and 2. The primary outcome is accelerometer measured physical activity; secondary outcomes are self-report physical activity, quality of life, anxiety, depression, symptoms including fatigue. The following variables will also be examined to determine if these factors influence adherence and outcomes: self-efficacy, risk perception and treatments.\ud \ud Ethics and dissemination: Full ethical approval was granted by NRES Committees—North of Scotland (13/NS/0004; IRAS project ID: 121757) on 22 February 2013. The proposed work is novel in that it aims to test the feasibility and acceptability of using an evidence-based and theory driven existing cardiac rehabilitation service with patients with colorectal cancer. Should this model of rehabilitation prove to be clinically and cost effective we aim to conduct a randomised controlled trial of this intervention to measure effectiveness.\ud \ud Trial registration reference: ISRCTN63510637; UKCRN id 14092.

The role of paraprofessionals as behaviour therapists has been the subject of considerable debate and controversy. One of the major issues is whether such groups as occupational therapy helpers can...