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Background In 2014, a systematic review found large gaps in the quality of reporting of measures used in 86 published trials evaluating the effectiveness of patient decision aids (PtDAs). The purpose of this study was to update that review. Methods We examined measures of decision making used in 49 randomized controlled trials included in the 2014 and 2017 Cochrane Collaboration systematic review of PtDAs. Data on development of the measures, reliability, validity, responsiveness, precision, interpretability, feasibility, and acceptability were independently abstracted by 2 paired reviewers. Results Information from 273 measures was abstracted, and 109 of these covered the core domains of decision processes ( n = 55) and decision quality including informed choice/knowledge ( n = 48) and values-choice concordance ( n = 12). Very few studies reported data on the performance and clinical sensibility of measures, with reliability (23%) and validity (6%) being the most common. Studies using new measures were less likely to include information about their psychometric performance compared with previously published measures. Limitations The review was limited to reporting of measures in studies included in the Cochrane review and did not consult prior publications. Conclusion There continues to be very little reported about the development or performance of measures used to evaluate the effectiveness of PtDAs in published trials. Minimum reporting standards have been published, and efforts to require investigators to use them are needed.

Rapid thrombolysis treatment for acute ischemic stroke reduces disability among patients who are carefully selected, but service delivery is challenging.To determine whether an enhanced Paramedic Acute Stroke Treatment Assessment (PASTA) intervention increased hospital thrombolysis rates.This multicenter, cluster randomized clinical trial took place between December 2015 and July 2018 in 3 ambulance services and 15 hospitals. Clusters were paramedics based within ambulance stations prerandomized to PASTA or standard care. Patients attended by study paramedics were enrolled after admission if a hospital specialist confirmed a stroke and paramedic assessment started within 4 hours of onset. Allocation to PASTA or standard care reflected the attending paramedic's randomization status.The PASTA intervention included additional prehospital information collection, a structured hospital handover, practical assistance up to 15 minutes after handover, a predeparture care checklist, and clinician feedback. Standard care reflected national guidelines.Primary outcome was the proportion of patients receiving thrombolysis. Secondary outcomes included time intervals and day 90 health (with poor status defined as a modified Rankin Score2, to represent dependency or death).A total of 11 478 patients were screened following ambulance transportation; 1391 were eligible and approached, but 177 did not consent. Of 1214 patients enrolled (mean [SD] age, 74.7 [13.2] years; 590 women [48.6%]), 500 were assessed by 242 paramedics trained in the PASTA intervention and 714 were assessed by 355 paramedics continuing with standard care. The paramedics trained in the PASTA intervention took a mean of 13.4 (95% CI, 9.4-17.4) minutes longer (P .001) to complete patient care episodes. There was less thrombolysis among the patients in the PASTA group, but this was not significant (PASTA group, 197 of 500 patients [39.4%] vs the standard care group, 319 of 714 patients [44.7%]; adjusted odds ratio, 0.81 [95% CI, 0.61-1.08]; P = .15). Time from a paramedic on scene to thrombolysis was a mean of 8.5 minutes longer in the PASTA group (98.1 [37.6] minutes) vs the standard care group (89.4 [31.1] minutes; P = .01). Poor health outcomes did not differ significantly but occurred less often among patients in the PASTA group (313 of 489 patients [64.0%]) vs the standard care group (461 of 690 patients [66.8%]; adjusted odds ratio, 0.86 [95% CI, 0.60-1.20]; P = .39).An enhanced paramedic assessment did not facilitate thrombolysis delivery. The unexpected combination of thrombolysis and health outcomes suggests possible alternative influences on treatment decisions by the intervention, requiring further evaluation.ISRCTN Registry Identifier: ISRCTN12418919.

Introduction Despite their efficacy in reducing stroke risk in patients with atrial fibrillation (AF), oral anticoagulants (OACs) remain under-prescribed [1]. Until recently, warfarin has been the dominant OAC. The introduction of direct oral anticoagulants (DOACs) led to changes in anticoagulant prescribing patterns, with an increase in OAC prescribing and a shift towards DOACs [2]. Treatment decisions for OACs are complicated, and require a discussion between clinicians and patients when deciding on a treatment [1]. Aim To investigate the main factors that influence initial and ongoing OAC prescribing decisions for patients with AF according to patient and health professional views. Methods A systematic review was conducted according to the Toolkit for Mixed-Methods Reviews, and was registered on PROSPERO: CRD42019145406. Medline, CINAHL, Scopus, EMBASE, Web of Knowledge and PsychInfo were searched in August, 2019. Primary qualitative and quantitative studies, published between 2009 and 2019, exploring patient and health professional perceptions, views and experiences of OACs in AF were included. McMaster critical appraisal tool for quantitative studies and Critical Appraisal Skills Programme (CASP) checklist for qualitative studies were used for quality assessment. The review followed a convergent integrated approach to data extraction and analysis, which involves extracting and analysing results of quantitative and qualitative studies at the same time using the same method. A data extraction form was adapted from Joanna-Briggs Institute (JBI) mixed-methods extraction form. Study author interpretation of quantitative data was summarised as qualitative statements which were coded together with primary qualitative data using NVIVO 12 software; codes were applied to each sentence in the findings, and were grouped into a hierarchical tree structure Results The systematic review included 62 papers (58 studies) discussing clinical and non-clinical factors influencing decisions to initiate OACs, the choice between warfarin and DOACs, and the choice between individual OACs. The balance of stroke and bleeding risks was the most influential when making the decision to initiate anticoagulation according to both patients and health professionals. Convenience-related factors, such as monitoring requirements, dosing regimens, and interactions impacted the choice between warfarin and DOACs, whereas, reversibility and dosing regimen influenced the choice between individual medications according to the views of both groups. Health professional specialty and years of experience affected all aspects of treatments, with specialists and senior clinicians more willing to initiate anticoagulation and choose DOACs. Even though health professionals often expressed that patient views were considered when deciding on a treatment, patients generally said that they followed their physician’s recommendations without questioning. Conclusion The review revealed similarities and differences across patient and professional views, experiences, and preferences of anticoagulation. The main discrepancies were related to the decision-making process, and whether patient views are being considered when prescribing. Combining quantitative and qualitative evidence helped explore a wide range of views of OAC and AF, however the review only included published research papers in English, which might have led to exclusion of valuable evidence. More research is needed to explore the factors driving the choice between OACs, especially the choice between individual DOACs. References 1. Noseworthy PA, Brito JP, Kunneman M, Hargraves IG, Zeballos-Palacios C, Montori VM, Ting HH. Shared decision-making in atrial fibrillation: navigating complex issues in partnership with the patient. Journal of Interventional Cardiac Electrophysiology. 2019;56(2):159–163. 2. Loo, S.Y., Dell'Aniello, S., Huiart, L. and Renoux, C. Trends in the prescription of novel oral anticoagulants in UK primary care. British Journal of Clinical Pharmacology. 2017; 83(9): 2096–2106.

Background Despite evidence from clinical trials that intravenous (IV) thrombolysis is a cost-effective treatment for selected acute ischaemic stroke patients, there remain large variations in the rate of IV thrombolysis delivery between stroke services. This study is evaluating whether an enhanced care pathway delivered by paramedics (the Paramedic Acute Stroke Treatment Assessment (PASTA)) could increase the number of patients who receive IV thrombolysis treatment. Methods Study design: Cluster randomised trial with economic analysis and parallel process evaluation. Setting: National Health Service ambulance services, emergency departments and hyper-acute stroke units within three geographical regions of England and Wales. Randomisation: Ambulance stations within each region are the units of randomisation. According to station allocation, paramedics based at a station deliver the PASTA pathway (intervention) or continue with standard stroke care (control). Study intervention: The PASTA pathway includes structured pre-hospital information collection, prompted pre-notification, structured handover of information in hospital and assistance with simple tasks during the initial hospital assessment. Study-trained intervention group paramedics deliver this pathway to adults within 4 h of suspected stroke onset. Study control: Standard stroke care according to national and local guidelines for the pre-hospital and hospital assessment of suspected stroke. Participants: Participants enrolled in the study are adults with confirmed stroke who were assessed by a study paramedic within 4 h of symptom onset. Primary outcome: Proportion of participants receiving IV thrombolysis. Sample size: 1297 participants provide 90% power to detect a 10% difference in the proportion of patients receiving IV thrombolysis. Discussion The results from this trial will determine whether an enhanced care pathway delivered by paramedics can increase thrombolysis delivery rates. Trial registration ISRCTN registry, ISRCTN12418919. Registered on 5 November 2015. Electronic supplementary material The online version of this article (10.1186/s13063-018-3144-z) contains supplementary material, which is available to authorized users.

BackgroundIntravenous thrombolysis is a key element of emergency treatment for acute ischaemic stroke, but hospital service delivery is variable. The Paramedic Acute Stroke Treatment Assessment (PASTA) multicentre cluster randomised controlled trial evaluated whether an enhanced paramedic-initiated stroke assessment pathway could improve thrombolysis volume. This paper reports the findings of a parallel process evaluation which explored intervention paramedics’ experience of delivering the enhanced assessment.MethodsInterviewees were recruited from 453 trained intervention paramedics across three UK ambulance services hosting the trial: North East, North West and Welsh Ambulance Services. A semistructured interview guide aimed to (1) explore the stroke-specific assessment and handover procedures which were part of the PASTA pathway and (2) enable paramedics to share relevant views about expanding their role and any barriers/enablers they encountered. Interviews were audiorecorded, transcribed verbatim and analysed following the principles of the constant comparative method.ResultsTwenty-six interviews were conducted (11 North East, 10 North West and 5 Wales). Iterative data analysis identified four key themes, which reflected paramedics’ experiences at different stages of the care pathway: (1) Enhanced assessment at scene: paramedics felt this improved their skillset and confidence. (2) Prealert to hospital: a mixed experience dependent on receiving hospital staff. (3) Handover to hospital team: standardisation of format was viewed as the primary benefit of the PASTA pathway. (4) Assisting in hospital and feedback: due to professional boundaries, paramedics found these aspects harder to achieve, although feedback from the clinical team was valued when available.ConclusionParamedics believed that the PASTA pathway enhanced their skills and the emergency care of stroke patients, but a continuing clinical role postadmission was challenging. Future studies should consider whether interdisciplinary training is needed to enable more radical extension of professional boundaries for paramedics.

Background Ambulance paramedics play a critical role expediting patient access to emergency treatments. Standardised handover communication frameworks have led to improvements in accuracy and speed of information transfer but their impact upon time-critical scenarios is unclear. Patient outcomes might be improved by paramedics staying for a limited time after handover to assist with shared patient care. We aimed to categorize and synthesise data from studies describing development/extension of the ambulance-based paramedic role during and after handover for time-critical conditions (trauma, stroke and myocardial infarction). Methods We conducted an electronic search of published literature (Jan 1990 to Sep 2016) by applying a structured strategy to eight bibliographic databases. Two reviewers independently assessed eligible studies of paramedics, emergency medical (or ambulance) technicians that reported on the development, evaluation or implementation of (i) generic or specific structured handovers applied to trauma, stroke or myocardial infarction (MI) patients; or (ii) paramedic-initiated care processes at handover or post-handover clinical activity directly related to patient care in secondary care for trauma, stroke and MI. Eligible studies had to report changes in health outcomes. Results We did not identify any studies that evaluated the health impact of an emergency ambulance paramedic intervention following arrival at hospital. A narrative review was undertaken of 36 studies shortlisted at the full text stage which reported data relevant to time-critical clinical scenarios on structured handover tools/protocols; protocols/enhanced paramedic skills to improve handover; or protocols/enhanced paramedic skills leading to a change in in-hospital transfer location. These studies reported that (i) enhanced paramedic skills (diagnosis, clinical decision making and administration of treatment) might supplement handover information; (ii) structured handover tools and feedback on handover performance can impact positively on paramedic behaviour during clinical communication; and (iii) additional roles of paramedics after arrival at hospital was limited to ‘direct transportation’ of patients to imaging/specialist care facilities. Conclusions There is insufficient published evidence to make a recommendation regarding condition-specific handovers or extending the ambulance paramedic role across the secondary/tertiary care threshold to improve health outcomes. However, previous studies have reported non-clinical outcomes which suggest that structured handovers and enhanced paramedic actions after hospital arrival might be beneficial for time-critical conditions and further investigation is required.

Objective An increasing number of patients in the working population are undergoing total knee replacement (TKR) for end-stage osteoarthritis. The timing and success of return to work is becoming increasingly important for this group of patients with social and economic implications for patients, employers and society. There is limited understanding of the patient variables that determine the ability to return to work. Our objective was (from the patient9s perspective) to gain an insight into the factors influencing return to work following knee replacement. Setting and participants This qualitative study was undertaken in a secondary-care setting in a large teaching hospital in the north of England. Semistructured interviews were carried out with 10 patients regarding their experiences of returning to work following TKR. Outcomes Interviews were transcribed and analysed using a qualitative thematic approach to identify the factors influencing return to work from the patient9s perspective. Results Three themes were identified that influenced the process of return to work, from the patient9s perspective. These were delays in surgical intervention, limited and often inconsistent advice from healthcare professionals regarding return to work, and finally the absence of rehabilitation to optimise patient9s recovery and facilitate return to work. Conclusions There is currently no consistent process to optimise return to work for patients of working age after TKR. The impact of delayed surgical intervention, limited advice regarding return to work, and a lack of work-focused rehabilitation, all contribute to potential delays in successful return to work. There is a need to change the focus of healthcare provision for this cohort of patients, and provide a tailored healthcare intervention to optimise patient outcomes.

SummaryShared decision making in clinical practice involves both the healthcare professional, an expert in the clinical condition and the patient who is an expert in what is important to them. A consultation involving shared decision making enables an examination of the options available, consideration of the risks and benefits whilst incorporating the values of the patient into the decision making process. A decision is aimed at, which is both clinically appropriate and is congruent with the patient's values.Older people have been shown to value involvement, to varying degrees, in decisions about their care and treatment. The case of atrial fibrillation shows the opportunities for, and benefits of, sharing with older people decision making about their healthcare.

Background An increasing number of patients in the working population are undergoing total hip and knee replacement for osteoarthritis and the timing and success of return to work (RTW) is becoming increasingly important as a measure of success for these patients. There is limited understanding of the patient variables that determine the ability to RTW. Aims To explore the factors influencing RTW following hip and knee replacement from the patient's perspective. Methods A cross-sectional population-based postal survey carried out with patients of working age after hip and knee replacement surgery in a UK teaching hospital. Free text comments were collected regarding the experiences of patients returning to work following hip and knee replacement. Qualitative thematic analysis was undertaken to identify the factors influencing RTW from the patient's perspective. Results From the patients' perspective three key factors were identified that influenced RTW. Patients reported an improved physical and psychological performance at work after surgery in comparison to pre-operative functioning, although there was a lack of informed advice regarding RTW after surgery. Workplace support and adaptation of the job role enhanced the experience of RTW. Conclusions Return to work is influenced by a combination of patient, clinician and occupational factors. The relationship between each of these needs to be explored in greater depth through further qualitative work to gain a wider understanding of the variables influencing patients' RTW following hip and knee replacement.

Flexibility in the design and enactment of spaces of healthcare is important in how providers respond to variations in patient expectations and experience. Health geographers have contributed to a wide body of literature concerning the therapeutic qualities of landscapes and the material, social and symbolic orderings of place and their uniqueness for individuals. In this paper, we draw upon these findings and a 'culture of place' approach to consider the complexities of maternity care and issues of pain relief. Given that pain is widely held to be a subjective experience and one that, in an era of patient decision making, increasingly demands discretionary approaches to its relief, we consider how medical professionals help to construct flexibility in healthcare and how this affects therapeutic landscapes. Drawing on analysis of four focus groups involving parent educators, midwives, health visitors, anaesthetists and obstetricians in the NE of England, we explore the material and discursive construction of flexible therapeutic landscapes and pain relief. Our findings suggest that flexibility is constrained and fashioned in association with health care professional's sense of place as already constituted. We propose that providing maternity care professionals with an explicit awareness of how places are relationally constructed, may help in expanding the therapeutic qualities of particular settings, and support a (more) flexible approach.

Background Establishing the effectiveness of patient decision aids (PtDA) requires evidence that PtDAs improve the quality of the decision-making process and the quality of the choice made, or decision quality. The aim of this paper is to review the theoretical and empirical evidence for PtDA effectiveness and discuss emerging practical and research issues in the measurement of effectiveness. Methods This updated overview incorporates: a) an examination of the instruments used to measure five key decision-making process constructs (i.e., recognize decision, feel informed about options and outcomes, feel clear about goals and preferences, discuss goals and preferences with health care provider, and be involved in decisions) and decision quality constructs (i.e., knowledge, realistic expectations, values-choice agreement) within the 86 trials in the Cochrane review; and b) a summary of the 2011 Cochrane Collaboration’s review of PtDAs for these key constructs. Data on the constructs and instruments used were extracted independently by two authors from the 86 trials and any disagreements were resolved by discussion, with adjudication by a third party where required. Results The 86 studies provide considerable evidence that PtDAs improve the decision-making process and decision quality. A majority of the studies (76/86; 88%) measured at least one of the key decision-making process or decision quality constructs. Seventeen different measurement instruments were used to measure decision-making process constructs, but no single instrument covered all five constructs. The Decisional Conflict Scale was most commonly used (n = 47), followed by the Control Preference Scale (n = 9). Many studies reported one or more constructs of decision quality, including knowledge (n = 59), realistic expectation of risks and benefits (n = 21), and values-choice agreement (n = 13). There was considerable variability in how values-choice agreement was defined and determined. No study reported on all key decision-making process and decision quality constructs. Conclusions Evidence of PtDA effectiveness in improving the quality of the decision-making process and decision quality is strong and growing. There is not, however, consensus or standardization of measurement for either the decision-making process or decision quality. Additional work is needed to develop and evaluate measurement instruments and further explore theoretical issues to advance future research on PtDA effectiveness.

Background\ud Engagement in decision making is a key priority of modern healthcare. Women are encouraged to make decisions about pain relief in labour in the ante-natal period based upon their expectations of what labour pain will be like. Many women find this planning difficult. The aim of this qualitative study was to explore how women can be better supported in preparing for, and making, decisions during pregnancy and labour regarding pain management.\ud \ud Methods\ud Semi-structured interviews were conducted with 13 primiparous and 10 multiparous women at 36 weeks of pregnancy and again within six weeks postnatally. Data collection and analysis occurred concurrently to identify key themes.\ud \ud Results\ud Three main themes emerged from the data. Firstly, during pregnancy women expressed a degree of uncertainty about the level of pain they would experience in labour and the effect of different methods of pain relief. Secondly, women reflected on how decisions had been made regarding pain management in labour and the degree to which they had felt comfortable making these decisions. Finally, women discussed their perceived levels of control, both desired and experienced, over both their bodies and the decisions they were making.\ud \ud Conclusion\ud This study suggests that the current approach of antenatal preparation in the NHS, of asking women to make decisions antenatally for pain relief in labour, needs reviewing. It would be more beneficial to concentrate efforts on better informing women and on engaging them in discussions around their values, expectations and preferences and how these affect each specific choice rather than expecting them to make to make firm decisions in advance of such an unpredictable event as labour.

Background. This review systematically appraises the quality of reporting of measures used in trials to evaluate the effectiveness of patient decision aids (PtDAs) and presents recommendations for minimum reporting standards. Methods. We reviewed measures of decision quality and decision process in 86 randomized controlled trials (RCTs) from the 2011 Cochrane Collaboration systematic review of PtDAs. Data on development of the measures, reliability, validity, responsiveness, precision, interpretability, feasibility, and acceptability were independently abstracted by 2 reviewers. Results. Information from 178 instances of use of measures was abstracted. Very few studies reported data on the performance of measures, with reliability (21%) and validity (16%) being the most common. Studies using new measures were less likely to include information about their psychometric performance. The review was limited to reporting of measures in studies included in the Cochrane review and did not consult prior publications. Conclusions. Very little is reported about the development or performance of measures used to evaluate the effectiveness of PtDAs in published trials. Minimum reporting standards are proposed to enable authors to prepare study reports, editors and reviewers to evaluate submitted papers, and readers to appraise published studies.

Background Outcomes for stroke patients can be improved by rapid identification and assessment, but delays commonly occur due to the availability of clinical information and brain imaging. We sought to develop a novel paramedic-led intervention to reduce scene to needle time for stroke patients suitable for thrombolysis. Methods Over 12 months we undertook group interviews and consultation in North East England, North West England and Wales involving patient representatives (n=20), paramedics, emergency department and stroke service hospital staff (n=100). The primary aim was to understand the impact of organisational boundaries, service pressures and traditional professional roles upon a new paramedic approach to stroke assessment. Secondly, to develop a clinical trial protocol for later evaluation of the proposed new paramedic approach. All interviews were digitally recorded, transcribed and analysed using open then focussed coding. Results Participant feedback supported an intervention which transgressed organisational and professional boundaries. Modifications were made following participant views about logistical, ethical and governance issues: ▸ The protocol was changed to reflect operational barriers restricting paramedics taking patients directly to the CT scan room. ▸ Participants advocated obtaining research consent after admission in order to address concerns over treatment delays, and supported a trial protocol which allowed data collection from patients that died before consent was feasible. ▸ Paramedics would provide additional information at patient handover directly to the stroke team or A&E staff rather than attempt to convey more during pre-notification. Conclusions Following the interviews significant alterations were made to the intervention and protocol in order to improve trial feasibility, acceptability and data quality. This emphasizes the importance of engaging with ambulance services, other clinical teams and patients during the development of pre-hospital research protocols.

Background Childbirth is one of the most painful events that a woman is likely to experience, the multi-dimensional aspect and intensity of which far exceeds disease conditions. A woman's lack of knowledge about the risks and benefits of the various methods of pain relief can heighten anxiety. Women are increasingly expected, and are expecting, to participate in decisions about their healthcare. Involvement should allow women to make better-informed decisions; the National Institute for Clinical Excellence has stated that we need effective ways of supporting pregnant women in making informed decisions during labour. Our aim was to systematically review the empirical literature on women's expectations and experiences of pain and pain relief during labour, as well as their involvement in the decision-making process. Methods A systematic review was conducted using the following databases: Medical Literature Analysis and Retrieval System Online (MEDLINE), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Bath Information and Database Service (BIDS), Excerpta Medica Database Guide (EMBASE), Midwives Information and Resource (MIDIRS), Sociological Abstracts and PsychINFO. Studies that examined experience and expectations of pain, and its relief in labour, were appraised and the findings were integrated into a systematic review. Results Appraisal revealed four key themes: the level and type of pain, pain relief, involvement in decision-making and control. Studies predominantly showed that women underestimated the pain they would experience. Women may hope for a labour free of pain relief, but many found that they needed or benefited from it. There is a distinction between women's desire for a drug-free labour and the expectation that they may need some sort of pain relief. Inaccurate or unrealistic expectations about pain may mean that women are not prepared appropriately for labour. Many women acknowledged that they wanted to participate in decision-making, but the degree of involvement varied. Women expected to take control in labour in a number of ways, but their degree of reported control was less than hoped for. Conclusion Women may have ideal hopes of what they would like to happen with respect to pain relief, control and engagement in decision-making, but experience is often very different from expectations. Antenatal educators need to ensure that pregnant women are appropriately prepared for what might actually happen to limit this expectation-experience gap and potentially support greater satisfaction with labour.

Purpose. To describe implementation of the UK Quality Indicator Project® (UK QIP) in the independent health care sector, drawing upon 10 years experience in the UK and approaching 20 years experience in the USA. We describe the history of the project, with an emphasis on recent developments, reflecting upon the critical features of the project and its value for participants. Background. The International Quality Indicator Project® is the largest international data set of quality indicators. It provides participants with quarterly feedback of comparative indicator data and support for effective use of these data within the participants’ own quality improvement programmes. The UK QIP now includes about two-thirds of UK private sector acute hospitals. The UK QIP began as a pilot project in the National Health Service (NHS) public sector in 1991. Implementation of the NHS performance assessment framework, and associated indicator programme, led to a reduction in public sector involvement. In contrast, the private sector, led by the Independent Healthcare Association, sought to identify a provider of key performance indicators to support both internal, within-sector drives for quality improvement and external demands produced by governmental review and the introduction of the National Care Standards Commission. The UK QIP was chosen since it provided a validated, epidemiologically sound system with capacity for support, education and flexibility to meet the changing demands of the sector. The future development of the QIP within the sector, including expansion from acute hospitals to mental health, is described. Conclusions. Reflection on the process of engagement of the UK independent sector with the QIP emphasizes the generic nature of the project and offers insights into the value of the project. Future challenges, including the issue of public accountability, are discussed in light of the project’s underlying philosophy and purpose.

Introduction Pregnant women expect to be involved in decisions about their care with clinicians, sharing information, knowledge and experience, in order to make decisions together. Shared decision making is especially pertinent in management of pain in labour where there are many options available, with varying degrees of evidence and acceptability. Objective To better understand the current decision making process and expectations and experience regarding pain relief in labour. To understand from both pregnant women9s and the professionals9 perspectives how this could be improved. Methods Semistructured interviews with women at various stages of pregnancy and focus groups with obstetricians, anaesthetists, delivery suite and community midwives. Data analysed using the constant comparison method. Results There was agreement among professionals that women were generally unprepared for labour. Women reported accessing many different sources of information but still felt largely unprepared. There was discordance between what the professionals said they told women and the information women wanted. There was also little evidence that women9s values were elicited to help them choose pain relief that matched their preferences and values for example, if midwives knew women valued mobility, it is clear an epidural wouldn9t be congruent with her values and this mismatching would need to be discussed with the woman. Conclusion Work needs to be undertaken in the form of decision support with both women and professionals to ensure that women are adequately prepared in order to engage in the decision making process, to ensure that shared decision making is a reality and not an aspiration.

The 1980s and 90s have seen the proliferation of all forms of performance indicators as part of attempts to command and control health services. The latest area to receive attention is health outcomes. Published league tables of mortality and other health outcomes have been available in the United States for some time and in Scotland since the early 1990s; they have now been developed for England and Wales. Publication of these data has proceeded despite warnings as to their limited meaningfulness and usefulness. The time has come to ask whether the remedy is worse than the malady: are published health outcomes contributing to quality efforts or subverting more constructive approaches? This paper argues that attempts to force improvements through publishing health outcomes can be counterproductive, and outlines an alternative approach which involves fostering greater trust in professionalism as a basis for quality enhancements.

BackgroundMany patients awaiting lung transplantation die before a donor organ becomes available. Ex vivo lung perfusion (EVLP) allows initially unusable donor lungs to be assessed and reconditioned for clinical use.ObjectiveThe objective of the Donor Ex Vivo Lung Perfusion in UK lung transplantation study was to evaluate the clinical effectiveness and cost-effectiveness of EVLP in increasing UK lung transplant activity.DesignA multicentre, unblinded, non-randomised, non-inferiority observational study to compare transplant outcomes between EVLP-assessed and standard donor lungs.SettingMulticentre study involving all five UK officially designated NHS adult lung transplant centres.ParticipantsPatients aged ≥ 18 years with advanced lung disease accepted onto the lung transplant waiting list.InterventionThe study intervention was EVLP assessment of donor lungs before determining suitability for transplantation.Main outcome measuresThe primary outcome measure was survival during the first 12 months following lung transplantation. Secondary outcome measures were patient-centred outcomes that are influenced by the effectiveness of lung transplantation and that contribute to the health-care costs.ResultsLungs from 53 donors unsuitable for standard transplant were assessed with EVLP, of which 18 (34%) were subsequently transplanted. A total of 184 participants received standard donor lungs. Owing to the early closure of the study, a non-inferiority analysis was not conducted. The Kaplan–Meier estimate of survival at 12 months was 0.67 [95% confidence interval (CI) 0.40 to 0.83] for the EVLP arm and 0.80 (95% CI 0.74 to 0.85) for the standard arm. The hazard ratio for overall 12-month survival in the EVLP arm relative to the standard arm was 1.96 (95% CI 0.83 to 4.67). Patients in the EVLP arm required ventilation for a longer period and stayed longer in an intensive therapy unit (ITU) than patients in the standard arm, but duration of overall hospital stay was similar in both groups. There was a higher rate of very early grade 3 primary graft dysfunction (PGD) in the EVLP arm, but rates of PGD did not differ between groups after 72 hours. The requirement for extracorporeal membrane oxygenation (ECMO) support was higher in the EVLP arm (7/18, 38.8%) than in the standard arm (6/184, 3.2%). There were no major differences in rates of chest radiograph abnormalities, infection, lung function or rejection by 12 months. The cost of EVLP transplants is approximately £35,000 higher than the cost of standard transplants, as a result of the cost of the EVLP procedure, and the increased ECMO use and ITU stay. Predictors of cost were quality of life on joining the waiting list, type of transplant and number of lungs transplanted. An exploratory model comparing a NHS lung transplant service that includes EVLP and standard lung transplants with one including only standard lung transplants resulted in an incremental cost-effectiveness ratio of £73,000. Interviews showed that patients had a good understanding of the need for, and the processes of, EVLP. If EVLP can increase the number of usable donor lungs and reduce waiting, it is likely to be acceptable to those waiting for lung transplantation. Study limitations include small numbers in the EVLP arm, limiting analysis to descriptive statistics and the EVLP protocol change during the study.ConclusionsOverall, one-third of donor lungs subjected to EVLP were deemed suitable for transplant. Estimated survival over 12 months was lower than in the standard group, but the data were also consistent with no difference in survival between groups. Patients receiving these additional transplants experience a higher rate of early graft injury and need for unplanned ECMO support, at increased cost. The small number of participants in the EVLP arm because of early study termination limits the robustness of these conclusions. The reason for the increased PGD rates, high ECMO requirement and possible differences in lung injury between EVLP protocols needs evaluation.Trial registrationCurrent Controlled Trials ISRCTN44922411.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 85. See the NIHR Journals Library website for further project information.