A mixed-methods study of women's birthplace preferences and decisions in England.

PROBLEM: Choice has been a key aspect of maternity care policy in England since 1993, however a gap remains between the birthplaces women want and where they actually give birth. BACKGROUND: The latest maternity care policy in England acknowledges that women are not being given 'real choice' in their care and often being told what to do. This is problematic since unfulfilled preferences have been linked to negative childbirth experiences. AIM: To understand the factors affecting women's birthplace preferences and decisions, and why these might differ. METHODS: A sequential mixed-methods study consisting of an online questionnaire (n=49) and follow-up interviews (n=14) with women who were either currently pregnant or had recently given birth in a metropolitan region in England. FINDINGS: Most women in this study said that they would prefer to give birth in an alongside maternity unit because it offered a compromise between the risk of poor outcomes and risk of unnecessary medicalisation. However, the majority of women's preferences were medicalised at the point of decision-making as the minimisation of clinical risk was ultimately prioritised. DISCUSSION: Women's preference for the alongside maternity unit demonstrates the growing popularity for this less medicalised, 'alternative' birthplace option. However pre-existing conditions, reproductive histories and experiential knowledge influence women's decision to give birth in the labour ward and suggests that minimising clinical risk is women's key priority. CONCLUSION: Women navigate complex and competing discourses when forming childbirth preferences and making decisions, selectively considering different risks and knowledges to make the decisions right for them.

Attitudes Toward Proactive Topical Corticosteroid Use Among Women With Vulval Lichen Sclerosus.

OBJECTIVES: Some practitioners are adopting proactive topical corticosteroid (TCS) therapy for vulval lichen sclerosus (VLS). We sought to understand patient attitudes toward proactive TCS therapy for VLS in a context in which proactive therapy is adopted. METHODS: Four online focus group discussions with 12 participants. Data analysis was informed by social constructionist grounded theory. RESULTS: All participants had accepted a proactive regimen. Three themes were developed from the analysis: "Coming to accept proactive therapy," "Motivators to maintaining a proactive regimen," and "The importance of a routine that fits me." Within each theme are subthemes illustrating different dimensions of the theme. CONCLUSIONS: Accepting proactive TCS therapy for VLS requires incorporating regular TCS use into a patient's identity, unlearning previous understandings regarding the safety of long-term TCS use, and adopting a regimen that fits within patients' lives and minimizes the loss of autonomy.

Education to improve timeliness of shingles diagnosis: Cluster RCT and qualitative study.

BACKGROUND: Herpes zoster (shingles) is normally diagnosed clinically. Timely diagnosis is important so antiviral treatment can be started soon after rash onset. AIM: To assess whether a practice-level educational intervention, aimed at non-clinical patient-facing staff, improves the timely assessment of patients with shingles. DESIGN AND SETTING: Cluster randomised Study Within A Trial (SWAT) with nested qualitative study in General Practices in England. METHODS: Practices were cluster randomised 1:1, stratified by centre and minimised by practice list size and index of multiple deprivation score. Intervention practices were sent educational materials, highlighting the common presenting features of shingles and what action to take if suspected. The primary and secondary outcomes were the mean proportion of patients per practice seen within 72 hours and 144 of rash onset, respectively. Comparison between groups was conducted using linear regression, adjusting for randomisation variables. Semi-structured interviews with practice staff in intervention practices explored views and opinions of the intervention. RESULTS: 67 practices were enrolled; 34 randomised to intervention, 33 to control. The mean difference in proportion of patients seen within 72 and 144 hours was -0.132 (95% CI -0.308, 0.043) and -0.039 (95% CI -0.158, 0.080), respectively. In intervention practices, 90.5% reported distributing the educational materials, however engagement with these was suboptimal. 12 participants were interviewed, and the poster component of the intervention was said to be easiest to implement. CONCLUSION: Our educational intervention did not improve the timely assessment of patients with shingles. This may be the result of poor intervention engagement.

Clinical effectiveness of pharmacological interventions for managing chronic migraine in adults: a systematic review and network meta-analysis.

BACKGROUND: Chronic migraine can be a profoundly disabling disorder that may be treated with preventive medications. However, uncertainty remains as to which preventive medication is the most effective. We present a network meta-analysis to determine the effectiveness and rank of preventive drugs for chronic migraine in adults. METHODS: We identified, reviewed, and extracted data from randomised controlled trials (RCTs) of preventive drugs for chronic migraine with at least 200 participants. Data were analysed using network meta-analysis. FINDINGS: We included 12 RCTs of six medications (Eptinezumab, Erenumab, Fremanezumab, Galcanezumab, Onabotulinumtoxin A, and Topiramate) compared to placebo or each other. All drugs effectively reduced monthly headache and migraine days compared with placebo. The most effective drug for monthly headache days was Eptinezumab 300mg, with a mean difference of -2.46 days, 95% Credible Interval (CrI): -3.23 to -1.69. On the Surface Under the Cumulative Ranking Area (SUCRA) analysis, the probability that Eptinezumab 300mg was ranked highest was 0.82. For monthly migraine days, the most effective medication was Fremanezumab-monthly, with a mean difference: -2.77 days, 95% CrI: -3.36 to -2.17, and 0.98 probability of being ranked the highest. All included drugs, except Topiramate, improved headache-related quality of life. No eligible studies were identified for the other common preventive oral medications such as Amitriptyline, Candesartan, and Propranolol. The main reasons were that the studies did not define chronic migraine, were undertaken before the definition of chronic migraine, or were too small. INTERPRETATION: All six medications were more effective than the placebo on monthly headache and migraine days. The absolute differences in the number of headache/migraine days are, at best, modest. No evidence was found to determine the relative effectiveness of the six included drugs with other oral preventive medications. REGISTRATION: PROSPERO (number CRD42021265990).

UK robotic arthroplasty clinical and cost effectiveness randomised controlled trial for hips (RACER-Hip): a study protocol.

INTRODUCTION: The number of robotic-assisted hip replacement procedures has expanded globally with the intended aim of improving outcomes. Intraoperative robotic-arm systems add additional costs to total hip replacement (THR) surgery but may improve surgical precision and could contribute to diminished pain and improved function. Additionally, these systems may reduce the need for expensive revision surgery. Surgery with conventional instruments may be just as successful, quick and affordable. There is timely demand for a robust evaluation of this technology. METHODS AND ANALYSIS: The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial for Hips (RACER-Hip) is a multicentre (minimum of six UK sites), participant-assessor blinded, randomised controlled trial. 378 participants with hip osteoarthritis requiring THR will be randomised (1:1) to receive robotic-assisted THR, or THR using conventional surgical instruments. The primary outcome is the Forgotten Joint Score at 12 months post-randomisation; a patient-reported outcome measure assessing participants' awareness of their joint when undertaking daily activities. Secondary outcomes will be collected post-operatively (pain, blood loss and opioid usage) and at 3, 6, 12, 24 months, then 5 and 10 years postrandomisation (including function, pain, health-related quality of life, reoperations and satisfaction). Allocation concealment will be accomplished using a computer-based randomisation procedure on the day of surgery. Blinding methods include the use of sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will adhere to Consolidated Standards of Reporting Trials statements. ETHICS AND DISSEMINATION: The trial was approved by an ethics committee (Solihull Research Ethics Committee, 30 June 2021, IRAS: 295831). Participants will provide informed consent before agreeing to participate. Results will be disseminated using peer-reviewed journal publications, presentations at international conferences and through the use of social media. We will develop plans to disseminate to patients and public with our patient partners. TRIAL REGISTRATION NUMBER: ISRCTN13374625.

Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol.

INTRODUCTION: Robotic-assisted knee replacement systems have been introduced to healthcare services worldwide in an effort to improve clinical outcomes for people, although high-quality evidence that they are clinically, or cost-effective remains sparse. Robotic-arm systems may improve surgical accuracy and could contribute to reduced pain, improved function and lower overall cost of total knee replacement (TKR) surgery. However, TKR with conventional instruments may be just as effective and may be quicker and cheaper. There is a need for a robust evaluation of this technology, including cost-effectiveness analyses using both within-trial and modelling approaches. This trial will compare robotic-assisted against conventional TKR to provide high-quality evidence on whether robotic-assisted knee replacement is beneficial to patients and cost-effective for healthcare systems. METHODS AND ANALYSIS: The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial-Knee is a multicentre, participant-assessor blinded, randomised controlled trial to evaluate the clinical and cost-effectiveness of robotic-assisted TKR compared with TKR using conventional instruments. A total of 332 participants will be randomised (1:1) to provide 90% power for a 12-point difference in the primary outcome measure; the Forgotten Joint Score at 12 months postrandomisation. Allocation concealment will be achieved using computer-based randomisation performed on the day of surgery and methods for blinding will include sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will be reported in line with the Consolidated Standards of Reporting Trials statement. A parallel study will collect data on the learning effects associated with robotic-arm systems. ETHICS AND DISSEMINATION: The trial has been approved by an ethics committee for patient participation (East Midlands-Nottingham 2 Research Ethics Committee, 29 July 2020. NRES number: 20/EM/0159). All results from the study will be disseminated using peer-reviewed publications, presentations at international conferences, lay summaries and social media as appropriate. TRIAL REGISTRATION NUMBER: ISRCTN27624068.

Dinaciclib as an effective pan-cyclin dependent kinase inhibitor in platinum resistant ovarian cancer.

Background: Ovarian cancer (OC) is amongst the most lethal of common cancers in women. Lacking in specific symptoms in the early stages, OC is predominantly diagnosed late when the disease has undergone metastatic spread and chemotherapy is relied on to prolong life. Platinum-based therapies are preferred and although many tumors respond initially, the emergence of platinum-resistance occurs in the majority of cases after which prognosis is very poor. Upregulation of DNA damage pathways is a common feature of platinum resistance in OC with cyclin dependent kinases (CDKs) serving as key regulators of this process and suggesting that CDK inhibitors (CDKis) could be effective tools in the treatment of platinum resistant and refractory OC. Aim: The aim of this study was to evaluate the efficacy of CDKis in platinum resistant OC models and serve as a predictor of potential clinical utility. Methods: The efficacy of CDKi, dinaciclib, was determined in wildtype and platinum resistant cell line pairs representing different OC subtypes. In addition, dinaciclib was evaluated in primary cells isolated from platinum-sensitive and platinum-refractory tumors to increase the clinical relevance of the study. Results and conclusions: Dinaciclib proved highly efficacious in OC cell lines and primary cells, which were over a thousand-fold more sensitive to the CDKi than to cisplatin. Furthermore, cisplatin resistance in these cells did not influence sensitivity to dinaciclib and the two drugs combined additively in both platinum-sensitive and platinum-resistant OC cells suggesting a potential role for pan-CDKis (CDKis targeting multiple CDKs), such as dinaciclib, in the treatment of advanced and platinum-resistant OC.

Living with vulval lichen sclerosus: a qualitative interview study.

BACKGROUND: Vulval lichen sclerosus (VLS) is a chronic inflammatory condition predominantly affecting the anogenital skin. Symptoms can be distressing and affect quality of life and everyday activities. Very little research has been undertaken to explore the experience of living with VLS from the perspective of people with the condition. OBJECTIVES: To understand individuals' experiences of VLS and its impact on their lives. PARTICIPANTS AND METHODS: Semi-structured remote (telephone or video) interviews were conducted with a purposive sample of 20 women living in the UK with VLS recruited via online support groups and social media. Data collection and analysis was informed by social constructionist grounded theory, using a constant comparison method. RESULTS: We developed three themes to interpret the experience of living with VLS: missed opportunities (participants experienced delayed diagnosis, lack of information and disempowering encounters with healthcare professionals); learning to live with a long-term condition (the amount of work involved in learning how to self-manage the disease and the impact on everyday life); a secret life (experiences of the condition were often shrouded in secrecy, and there was stigma associated with a vulval skin condition resulting in them feeling isolated and lonely). CONCLUSIONS: Patients attending healthcare appointments with vulval complaints should be examined and LS should be considered as a diagnosis. Healthcare professionals' awareness and knowledge of VLS needs to be improved and they should avoid language which is blaming or minimizing of patients' experiences. VLS is a chronic condition and patients need to be supported in self-management. Support groups may be a source of support and information but can also be challenging when hearing others' difficult experiences. Wider public health educational activities are needed to change societal attitudes towards female genitals and tackle the stigma around vulval conditions. What is already known about this topic? Vulval lichen sclerosus (VLS) can have a profound impact on quality of life and self-identity but is relatively underexplored from the perspective of those living with the condition. What does this study add? In-depth findings about the experiences of living with VLS including ongoing issues with timely diagnosis, learning to live with a long-term condition and the secrecy and stigma about the condition. The needs of women with symptoms of and diagnoses of VLS are not being met sufficiently by the healthcare system. What are the clinical implications of this work? Healthcare professionals should consider addressing knowledge gaps in vulval conditions including VLS to prevent delayed diagnosis and avoid the use of certain terminology which can minimize patients' experiences. Patients with vulval complaints should be examined and LS should be considered as a diagnosis. Regular follow-up would reflect its chronic nature and could provide patients with reassurance and confidence in self-management. Wider public health activities are needed to change societal attitudes and tackle stigma around vulval conditions.

Exercise to prevent shoulder problems after breast cancer surgery: the PROSPER RCT.

BACKGROUND: Upper limb problems are common after breast cancer treatment. OBJECTIVES: To investigate the clinical effectiveness and cost-effectiveness of a structured exercise programme compared with usual care on upper limb function, health-related outcomes and costs in women undergoing breast cancer surgery. DESIGN: This was a two-arm, pragmatic, randomised controlled trial with embedded qualitative research, process evaluation and parallel economic analysis; the unit of randomisation was the individual (allocated ratio 1 : 1). SETTING: Breast cancer centres, secondary care. PARTICIPANTS: Women aged ≥ 18 years who had been diagnosed with breast cancer and were at higher risk of developing shoulder problems. Women were screened to identify their risk status. INTERVENTIONS: All participants received usual-care information leaflets. Those randomised to exercise were referred to physiotherapy for an early, structured exercise programme (three to six face-to-face appointments that included strengthening, physical activity and behavioural change strategies). MAIN OUTCOME MEASURES: The primary outcome was upper limb function at 12 months as assessed using the Disabilities of Arm, Hand and Shoulder questionnaire. Secondary outcomes were function (Disabilities of Arm, Hand and Shoulder questionnaire subscales), pain, complications (e.g. wound-related complications, lymphoedema), health-related quality of life (e.g. EuroQol-5 Dimensions, five-level version; Short Form questionnaire-12 items), physical activity and health service resource use. The economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year and incremental net monetary benefit gained from an NHS and Personal Social Services perspective. Participants and physiotherapists were not blinded to group assignment, but data collectors were blinded. RESULTS: Between 2016 and 2017, we randomised 392 participants from 17 breast cancer centres across England: 196 (50%) to the usual-care group and 196 (50%) to the exercise group. Ten participants (10/392; 3%) were withdrawn at randomisation and 32 (8%) did not provide complete baseline data. A total of 175 participants (89%) from each treatment group provided baseline data. Participants' mean age was 58.1 years (standard deviation 12.1 years; range 28-88 years). Most participants had undergone axillary node clearance surgery (327/392; 83%) and 317 (81%) had received radiotherapy. Uptake of the exercise treatment was high, with 181 out of 196 (92%) participants attending at least one physiotherapy appointment. Compliance with exercise was good: 143 out of 196 (73%) participants completed three or more physiotherapy sessions. At 12 months, 274 out of 392 (70%) participants returned questionnaires. Improvement in arm function was greater in the exercise group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 16.3 (standard deviation 17.6)] than in the usual-care group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 23.7 (standard deviation 22.9)] at 12 months for intention-to-treat (adjusted mean difference Disabilities of Arm, Hand and Shoulder questionnaire score of -7.81, 95% confidence interval -12.44 to -3.17; p = 0.001) and complier-average causal effect analyses (adjusted mean difference -8.74, 95% confidence interval -13.71 to -3.77; p ≤ 0.001). At 12 months, pain scores were lower and physical health-related quality of life was higher in the exercise group than in the usual-care group (Short Form questionnaire-12 items, mean difference 4.39, 95% confidence interval 1.74 to 7.04; p = 0.001). We found no differences in the rate of adverse events or lymphoedema over 12 months. The qualitative findings suggested that women found the exercise programme beneficial and enjoyable. Exercise accrued lower costs (-£387, 95% CI -£2491 to £1718) and generated more quality-adjusted life years (0.029, 95% CI 0.001 to 0.056) than usual care over 12 months. The cost-effectiveness analysis indicated that exercise was more cost-effective and that the results were robust to sensitivity analyses. Exercise was relatively cheap to implement (£129 per participant) and associated with lower health-care costs than usual care and improved health-related quality of life. Benefits may accrue beyond the end of the trial. LIMITATIONS: Postal follow-up was lower than estimated; however, the study was adequately powered. No serious adverse events directly related to the intervention were reported. CONCLUSIONS: This trial provided robust evidence that referral for early, supported exercise after breast cancer surgery improved shoulder function in those at risk of shoulder problems and was associated with lower health-care costs than usual care and improved health-related quality of life. FUTURE WORK: Future work should focus on the implementation of exercise programmes in clinical practice for those at highest risk of shoulder problems. TRIAL REGISTRATION: This trial is registered as ISRCTN35358984. 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. 26, No. 15. See the NIHR Journals Library website for further project information.

WHAT IS THE PROBLEM?: Breast cancer is the most common cancer affecting women. Women now live longer because the detection and treatment of cancer has improved over the last 40 years. The side effects of breast cancer treatments can lead to complications, such as difficulties with arm movements, arm swelling (lymphoedema), pain and poor quality of life. These problems can last for many years after the cancer has been treated. Usual care after breast cancer surgery is to give patients an information leaflet explaining arm exercises that they can undertake after their operation. Offering exercise support from a physiotherapist may be a better way to help those at risk of developing shoulder problems after breast cancer treatment than providing a leaflet only. WHAT DID WE DO?: We compared two strategies to prevent shoulder problems in women having breast cancer treatment: information leaflets and an exercise programme. We invited women with a new diagnosis of breast cancer who were at higher risk of developing shoulder problems than other women with a new diagnosis of breast cancer. We recruited 392 women aged 28­88 years from 17 breast cancer units across England. Women were allocated to one of two groups by chance using a computer. Everyone was given information leaflets that explained what type of exercises to do after surgery. Half of the women (n = 196) were then invited to take part in an exercise programme, supported by a trained physiotherapist. These women followed a programme of shoulder mobility, stretching and strengthening exercises for up to 1 year. We measured changes in arm function, pain, arm swelling (lymphoedema) and physical and mental quality of life, and the cost of treatments during the whole first year of recovery, in everyone. We also spoke to the women and physiotherapists to find out whether or not these treatment strategies were acceptable to them. WHAT DID WE FIND OUT?: Women doing the exercise programme had better arm function, less pain and better quality of life than the women given an information leaflet only. Women said that the exercise programme helped with their recovery during cancer treatment. Exercise was cheap to deliver (£129 per person) and led to improved overall quality of life at 1 year after breast cancer surgery.

Exploring trust in (bio)medical and experiential knowledge of birth: The perspectives of pregnant women, new mothers and maternity care providers.

OBJECTIVE: To explore women's and maternity care providers' experiences of birth, and the roles of (bio)medical and experiential knowledge therein. RESEARCH DESIGN/SETTING: In-depth qualitative interviews were undertaken with pregnant women and new mothers (n = 14) as well as with a range of maternity care providers working for the National Health Service (n = 6) and privately (n = 7). FINDINGS: Trust emerged as a key concept in women's and maternity care providers' narratives. It was found that women and maternity care providers placed trust in two key areas: trust in past experiences and trust in women's innate abilities and embodied knowledge of birth. KEY CONCLUSIONS: Women and maternity care providers trust and utilise both (bio)medical and experiential forms of knowledge of birth in complex ways and the value an individual ascribes to (bio)medical and/or experiential knowledge is highly subjective, and not necessarily mutually exclusive. This destabilises the notion that (bio)medical knowledge is associated with experts and experiential knowledge is associated with 'lay' people, and that these two bodies of knowledge are distinct. IMPLICATIONS FOR PRACTICE: Trust is a key concept in maternity care. The predominance of biomedical models of birth risk reducing trust in the value of experiential based birth knowledges - both embodied and empathetic. Trust in experiential knowledge could help to facilitate woman-centred care by recognising women as valuable 'knowers' with unique insight to contribute, and not just receivers of medical knowledge. It may also help providers 'tune-in' with the women in their care if they allow their experiential knowledge to complement their (bio)medical knowledge.

Impact of COVID-19 lockdown: Domestic and child abuse in Bridgend.

INTRODUCTION: Financial stress, social stress and lack of support at home can precipitate domestic and child abuse (World Health Organization, 2020). These factors have been exacerbated by the COVID-19 pandemic (NSPCC, 2020b) (NSPCC, 2020a). We hypothesise an increase in Bridgend's domestic and child abuse during lockdown. METHOD: Data was collected retrospectively from 23rd March to 30th September 2020 and compared to the same time period in 2019. Wales-wide data on domestic abuse was shared by the Welsh Government's Live Fear free helpline. Local data was shared by domestic abuse charity CALAN, the Emergency Department (ED) and Paediatric Department of Princess of Wales Hospital (POWH). RESULTS: During lockdown, Live Fear Free reported increasing average monthly contact across Wales in 2020 (511 April; 631 December). Locally, CALAN reported a 190% increase in self-referrals and a 198% increase in third party referrals, but there was a 36% decrease in referrals from Police for domestic abuse. The Paediatric Department observed a 67% decrease in child protection medical examinations (CPMEs) undertaken (52 vs. 17). 23 examinations in 2019 were referred from schools compared to 1 in 2020. There was a greater proportion of self-referrals for CPMEs in 2020. ED child protection referrals increased from 189 (2019) to 204 (2020). CONCLUSION: There was an increase in self-referrals to local support services for domestic and child abuse concerns and an increase in referrals from families/friends for child protection concerns. This was not the case with police, ED and schools/nurseries referrals. This suggests reduced engagement with public sector organisations during lockdown which services should consider.

Exercise versus usual care after non-reconstructive breast cancer surgery (UK PROSPER): multicentre randomised controlled trial and economic evaluation.

OBJECTIVE: To evaluate whether a structured exercise programme improved functional and health related quality of life outcomes compared with usual care for women at high risk of upper limb disability after breast cancer surgery. DESIGN: Multicentre, pragmatic, superiority, randomised controlled trial with economic evaluation. SETTING: 17 UK National Health Service cancer centres. PARTICIPANTS: 392 women undergoing breast cancer surgery, at risk of postoperative upper limb morbidity, randomised (1:1) to usual care with structured exercise (n=196) or usual care alone (n=196). INTERVENTIONS: Usual care (information leaflets) only or usual care plus a physiotherapy led exercise programme, incorporating stretching, strengthening, physical activity, and behavioural change techniques to support adherence to exercise, introduced at 7-10 days postoperatively, with two further appointments at one and three months. MAIN OUTCOME MEASURES: Disability of Arm, Hand and Shoulder (DASH) questionnaire at 12 months, analysed by intention to treat. Secondary outcomes included DASH subscales, pain, complications, health related quality of life, and resource use, from a health and personal social services perspective. RESULTS: Between 26 January 2016 and 31 July 2017, 951 patients were screened and 392 (mean age 58.1 years) were randomly allocated, with 382 (97%) eligible for intention to treat analysis. 181 (95%) of 191 participants allocated to exercise attended at least one appointment. Upper limb function improved after exercise compared with usual care (mean DASH 16.3 (SD 17.6) for exercise (n=132); 23.7 (22.9) usual care (n=138); adjusted mean difference 7.81, 95% confidence interval 3.17 to 12.44; P=0.001). Secondary outcomes favoured exercise over usual care, with lower pain intensity at 12 months (adjusted mean difference on numerical rating scale -0.68, -1.23 to -0.12; P=0.02) and fewer arm disability symptoms at 12 months (adjusted mean difference on Functional Assessment of Cancer Therapy-Breast+4 (FACT-B+4) -2.02, -3.11 to -0.93; P=0.001). No increase in complications, lymphoedema, or adverse events was noted in participants allocated to exercise. Exercise accrued lower costs per patient (on average -£387 (€457; $533) (95% confidence interval -£2491 to £1718; 2015 pricing) and was cost effective compared with usual care. CONCLUSIONS: The PROSPER exercise programme was clinically effective and cost effective and reduced upper limb disability one year after breast cancer treatment in patients at risk of treatment related postoperative complications. TRIAL REGISTRATION: ISRCTN Registry ISRCTN35358984.

Role of physiotherapy in supporting recovery from breast cancer treatment: a qualitative study embedded within the UK PROSPER trial.

OBJECTIVES: To explore the experiences of women with breast cancer taking part in an early physiotherapy-led exercise intervention compared with the experiences of those receiving usual care. To understand physiotherapists' experience of delivering the trial intervention. To explore acceptability of the intervention and issues related to the implementation of the Prevention Of Shoulder Problems (PROSPER) programme from participant and physiotherapist perspective. DESIGN: Qualitative semistructured interviews with thematic analysis. SETTING: UK National Health Service. PARTICIPANTS: Twenty participants at high risk of shoulder problems after breast cancer surgery recruited to the UK PROSPER trial (10 each from the intervention arm and control arm), and 11 physiotherapists who delivered the intervention. Trial participants were sampled using convenience sampling. Physiotherapists were purposively sampled from high and low recruiting sites. RESULTS: Participants described that the PROSPER exercise intervention helped them feel confident in what their body could do and helped them regain a sense of control in the context of cancer treatment, which was largely disempowering. Control arm participants expressed less of a sense of control over their well-being. Physiotherapists found the exercise intervention enjoyable to deliver and felt it was valuable to their patients. The extra time allocated for appointments during intervention delivery made physiotherapists feel they were providing optimal care, being the 'perfect physio'. Lessons were learnt about the implementation of a complex exercise intervention for women with breast cancer, and the issues raised will inform the development of a future implementation strategy. CONCLUSIONS: A physiotherapist-delivered early supported exercise intervention with integrated behavioural strategies helped women at risk of shoulder problems following breast cancer treatment to feel more confident in their ability to mobilise their arm post-surgery. A physiotherapist-delivered early supported exercise intervention with integrated behavioural strategies may address the sense of powerlessness that many women experience during breast cancer treatment.Trial registration number ISRCTN35358984.

The experiences of health care professionals, patients, and families of the process of referral and admission to intensive care: A systematic literature review.

Treatment in an intensive care unit can be life-saving but it can be distressing and not every patient can benefit. Decisions to admit a patient to an intensive care unit are complex. We wished to explore how the decision to refer or admit is experienced by those involved, and undertook a systematic review of the literature to answer the research question: What are the experiences of health care professionals, patients, and families, of the process of referral and admission to an intensive care unit? Twelve relevant studies were identified, and a thematic analysis was conducted. Most studies involved health care professionals, with only two considering patients' or families' experiences. Four themes were identified which influenced experiences of intensive care unit referral and review: the professional environment; communication; the allocation of limited resources; and acknowledging uncertainty. Patients' and families' experiences have been under-researched in this area.

Implementing an intervention to improve decision making around referral and admission to intensive care: Results of feasibility testing in three NHS hospitals.

RATIONALE, AIMS, AND OBJECTIVES: Decisions about whether to refer or admit a patient to an intensive care unit (ICU) are clinically, organizationally, and ethically challenging. Many explicit and implicit factors influence these decisions, and there is substantial variability in how they are made, leading to concerns about access to appropriate treatment for critically ill patients. There is currently no guidance to support doctors making these decisions. We developed an intervention with the aim of supporting doctors to make more transparent, consistent, patient-centred, and ethically justified decisions. This paper reports on the implementation of the intervention at three NHS hospitals in England and evaluates its feasibility in terms of usage, acceptability, and perceived impact on decision making. METHODS: A mixed method study including quantitative assessment of usage and qualitative interviews. RESULTS: There was moderate uptake of the framework (28.2% of referrals to ICU across all sites during the 3-month study period). Organizational structure and culture affected implementation. Concerns about increased workload in the context of limited resources were obstacles to its use. Doctors who used it reported a positive impact on decision making, with better articulation and communication of reasons for decisions, and greater attention to patient wishes. The intervention made explicit the uncertainty inherent in these decisions, and this was sometimes challenging. The patient and family information leaflets were not used. CONCLUSIONS: While it is feasible to implement an intervention to improve decision making around referral and admission to ICU, embedding the intervention into existing organizational culture and practice would likely increase adoption. The doctor-facing elements of the intervention were generally acceptable and were perceived as making ICU decision making more transparent and patient-centred. While there remained difficulties in articulating the clinical reasoning behind some decisions, the intervention offers an important step towards establishing a more clinically and ethically sound approach to ICU admission.

Patient experience of long-term recovery after open fracture of the lower limb: a qualitative study using interviews in a community setting.

OBJECTIVES: Treatment of open fractures is complex and patients may require muscle and skin grafts. The aim of this study was to gain a greater understanding of patient experience of recovery from open fracture of the lower limb 2-4 years postinjury. DESIGN: A phenomenological approach was used to guide the design of the study. Interviews took place between October 2016 and April 2017 in the participants' own homes or via telephone. SETTING: England, UK. PARTICIPANTS: A purposive sample of 25 patients were interviewed with an age range of 26-80 years (median 51), 19 were male and six female, and time since injury was 24-49 months (median 35 months). RESULTS: The findings identified a focus on struggling to recover as participants created a new way of living, balancing moving forward with accepting how they are, while being uncertain of the future and experiencing cycles of progress and setbacks. This was expressed through three themes: (i) 'being disempowered' with the emotional impact of dependency and uncertainty, (ii) 'being changed' and living with being fragile and being unable to move freely and (iii) 'being myself' with a loss of self, feeling and looking different, alongside recreation of self in which they integrated the past, present and future to find meaningful ways of being themselves. CONCLUSION: This study identified the long-term disruption caused by serious injury, the hidden work of integration that is required in order to move forward and maximise potential for recovery. Supportive strategies that help people to self-manage their everyday emotional and physical experience of recovery from injury are required. Research should focus on developing and testing effective interventions that provide support and self-management within a holistic rehabilitation plan. TRIAL REGISTRATION NUMBER: Current Controlled Trials ISRCTN33756652; Post-results.

Obstacles to returning to work with chronic pain: in-depth interviews with people who are off work due to chronic pain and employers.

BACKGROUND: The global burden of chronic pain is growing with implications for both an ageing workforce and employers. Many obstacles are faced by people with chronic pain in finding employment and returning to work after a period of absence. Few studies have explored obstacles to return-to-work (RTW) from workers' and employers' perspectives. Here we explore views of both people in pain and employers about challenges to returning to work of people who are off work with chronic pain. METHODS: We did individual semi-structured interviews with people who were off work (unemployed or off sick) with chronic pain recruited from National Health Service (NHS) pain services and employment services, and employers from small, medium, and large public or private sector organisations. We analysed data using the Framework method. RESULTS: We interviewed 15 people off work with chronic pain and 10 employers. Obstacles to RTW for people with chronic pain spanned psychological, pain related, financial and economic, educational, and work-related domains. Employers were concerned about potential attitudinal obstacles, absence, ability of people with chronic pain to fulfil the job requirements, and the implications for workplace relationships. Views on disclosure of the pain condition were conflicting with more than half employers wanting early full disclosure and two-thirds of people with chronic pain declaring they would not disclose for fear of not getting a job or losing a job. Both employers and people with chronic pain thought that lack of confidence was an important obstacle. Changes to the job or work conditions (e.g. making reasonable adjustments, phased return, working from home or redeployment) were seen by both groups as facilitators. People with chronic pain wanted help in preparing to RTW, education for managers about pain and supportive working relationships. CONCLUSIONS: People with chronic pain and employers may think differently in terms of perceptions of obstacles to RTW. Views appeared disparate in relation to disclosure of pain and when this needs to occur. They appeared to have more in common regarding opinions about how to facilitate successful RTW. Increased understanding of both perspectives may be used to inform the development of improved RTW interventions.

Oral anticoagulation is preferable to injected, but only if it is safe and effective: An interview study of patient and carer experience of oral and injected anticoagulant therapy for cancer-associated thrombosis in the select-d trial.

BACKGROUND: Cancer patients have a four- to fivefold greater risk of thrombosis than the general population. Recommended treatment for cancer-associated thrombosis is 3-6 months of low-molecular-weight heparin. The 'select-d' trial is an open-label, randomised, multi-centre pilot trial in patients with cancer-associated thrombosis, utilising dalteparin (low-molecular-weight heparin) versus rivaroxaban (a direct oral anticoagulant), to assess effectiveness and safety. AIM: To explore patient and informal carers' experiences of cancer-associated thrombosis and their experience and understanding of the risk-benefit of thrombosis treatment. DESIGN: Qualitative substudy of the select-d trial, using semi-structured interviews. Interviews were audio-recorded and transcribed. Data were analysed using Framework Analysis. PARTICIPANTS: Participants were purposively sampled ( n = 37 patients; 46% male; age 40-89; 9 with carer present). RESULTS: Three themes were found: experience of cancer-associated thrombosis, experience of anticoagulation and risk-benefit balance of the two modes of administration. Some were shocked by their thrombosis diagnosis (most were unaware of their risk), but others found it insignificant compared with cancer. Most patients found tablets more convenient, but injections were acceptable in the context of having cancer. While most were happy to follow medical advice, others weighed preference on the basis of effectiveness. CONCLUSION: Lack of awareness of thrombosis risk is concerning; cancer patients must be informed to enable prompt help-seeking. Tablets could provide a welcome choice for patients if there is equivalent risk-benefit to injected anticoagulants. Patients trust their clinicians to tailor their treatment. Future research could explore the effect of routine information giving about the risk of thrombosis.