Test, evidence, transition projects in Scotland: developing the evidence needed for transition of effective interventions in cancer care from innovation into mainstream practice.

BACKGROUND: A robust evidence base is required to assist healthcare commissioners and providers in selecting effective and sustainable approaches to improve cancer diagnosis and treatment. Such evidence can be difficult to build, given the fast-paced and highly pressured nature of healthcare delivery, the absence of incentives, and the presence of barriers in conducting pragmatic yet robust research evaluations. Cancer Research UK (CRUK) has played an active part in building the evidence base through its funding of programmes to identify, evaluate and scale-up innovative approaches across the UK. The aim of this paper is to describe and explain the research design and intended approach and activities for two cancer services improvement projects in Scotland funded by CRUK. METHODS: A hybrid effectiveness-implementation study design will assess both the efficiency of the new pathways and their implementation strategies, with the aim of generating knowledge for scale-up. A range of implementation, service and clinical outcomes will be assessed as determined by the projects' Theories of Change (ToCs). A naturalistic case study approach will enable in-depth exploration of context and process, and the collection and synthesis of data from multiple sources including routine datasets, patient and staff surveys, in-depth interviews and observational and other data. The evaluations are informed throughout by a patient/public representatives' group, and by small group discussions with volunteer cancer patients. DISCUSSION: Our approach has been designed to provide a holistic understanding of how (well) the improvement projects work (in relation to their anticipated outcomes), and how they interact with their wider contexts. The evaluations will help identify barriers, facilitators, and unanticipated consequences that can impact scalability, sustainability and spread. By opting for a pragmatic, participatory evaluation research design, we hope to inform strategies for scaling up successful innovations while addressing challenges in a targeted manner.

Emergency out-of-hours catheter ablation for ventricular arrhythmia storm: a UK and Australian experience.

AIMS: There are limited data on emergency catheter ablation (CA) for ventricular arrhythmia (VA) storm. We describe the feasibility and safety of performing emergency CA in an out-of-hours setting for VA storm refractory to medical therapy at 2 tertiary hospitals. METHODS AND RESULTS: Twenty-five consecutive patients underwent out-of-hours (5pm-8am [weekday] or Friday 5pm-Monday 8am [weekend]) CA for VA storm refractory to anti-arrhythmic drugs and sedation. Baseline and procedural characteristics along with outcomes were compared to 91 consecutive patients undergoing weekday daytime-hours (8am-5pm) CA for VA storm. More patients undergoing out-of-hours CA had a left ventricular ejection fraction ≤35% (68% vs. 42%, P = 0.022), chronic kidney disease (60% vs. 20%, P < 0.001), and presented following a resuscitated out-of-hospital cardiac arrest (56% vs. 5%, P < 0.001), compared to the daytime-hours group. During median follow-up (377 [interquartile range 138-826] days), both groups experienced similar survival free from recurrent VA and VA storm. Survival free from cardiac transplant and/or mortality was lower in the out-of-hours group (44% vs. 81%, P = 0.007), but out-of-hours CA was not independently associated with increased cardiac transplant and/or mortality (hazard ratio 1.34, 95% confidence interval 0.61-2.96, P = 0.47). Of the 11 patients in the out-of-hours group who survived follow-up, VA-free survival was 91% and VA storm-free survival was 100% at 1-year after CA. CONCLUSION: Out-of-hours CA may occasionally be required to control VA storm and can be safe and efficacious in this scenario. During follow-up, cardiac transplant and/or mortality is common but undergoing out-of-hours CA was not predictive of this composite endpoint.

Atrial fibrillation cryoablation is an effective day case treatment: the UK PolarX vs. Arctic Front Advance experience.

AIMS: Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation for atrial fibrillation (AF). There are limited data on the PolarX Cryoballoon. The study aimed to establish the safety, efficacy, and feasibility of same day discharge for Cryoballoon PVI. METHODS AND RESULTS: Multi-centre study across 12 centres. Procedural metrics, safety profile, and procedural efficacy of the PolarX Cryoballoon with the Arctic Front Advance (AFA) Cryoballoon were compared in a cohort large enough to provide definitive comparative data. A total of 1688 patients underwent PVI with cryoablation (50% PolarX and 50% AFA). Successful PVI was achieved with 1677 (99.3%) patients with 97.2% (n = 1641) performed as day case procedures with a complication rate of <1%. Safety, procedural metrics, and efficacy of the PolarX Cryoballoon were comparable with the AFA cohort. The PolarX Cryoballoon demonstrated a nadir temperature of -54.6 ± 7.6°C, temperature at 30 s of -38.6 ± 7.2°C, time to -40°C of 34.1 ± 13.7 s, and time to isolation of 49.8 ± 33.2 s. Independent predictors for achieving PVI included time to reach -40°C [odds ratio (OR) 1.34; P < 0.001] and nadir temperature (OR 1.24; P < 0.001) with an optimal cut-off of ≤34 s [area under the curve (AUC) 0.73; P < 0.001] and nadir temperature of ≤-54.0°C (AUC 0.71; P < 0.001), respectively. CONCLUSIONS: This large-scale UK multi-centre study has shown that Cryoballoon PVI is a safe, effective day case procedure. PVI using the PolarX Cryoballoon was similarly safe and effective as the AFA Cryoballoon. The cryoablation metrics achieved with the PolarX Cryoballoon were different to that reported with the AFA Cryoballoon. Modified cryoablation targets are required when utilizing the PolarX Cryoballoon.

Shared decision-making interventions for people with mental health conditions.

BACKGROUND: One person in every four will suffer from a diagnosable mental health condition during their life. Such conditions can have a devastating impact on the lives of the individual and their family, as well as society.  International healthcare policy makers have increasingly advocated and enshrined partnership models of mental health care. Shared decision-making (SDM) is one such partnership approach. Shared decision-making is a form of service user-provider communication where both parties are acknowledged to bring expertise to the process and work in partnership to make a decision.  This review assesses whether SDM interventions improve a range of outcomes. This is the first update of this Cochrane Review, first published in 2010. OBJECTIVES: To assess the effects of SDM interventions for people of all ages with mental health conditions, directed at people with mental health conditions, carers, or healthcare professionals, on a range of outcomes including: clinical outcomes, participation/involvement in decision-making process (observations on the process of SDM; user-reported, SDM-specific outcomes of encounters), recovery, satisfaction, knowledge, treatment/medication continuation, health service outcomes, and adverse outcomes. SEARCH METHODS: We ran searches in January 2020 in CENTRAL, MEDLINE, Embase, and PsycINFO (2009 to January 2020). We also searched trial registers and the bibliographies of relevant papers, and contacted authors of included studies.  We updated the searches in February 2022. When we identified studies as potentially relevant, we labelled these as studies awaiting classification. SELECTION CRITERIA: Randomised controlled trials (RCTs), including cluster-randomised controlled trials, of SDM interventions in people with mental health conditions (by Diagnostic and Statistical Manual of Mental Disorders (DSM) or International Classification of Diseases (ICD) criteria). DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Two review authors independently screened citations for inclusion, extracted data, and assessed risk of bias. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: This updated review included 13 new studies, for a total of 15 RCTs. Most participants were adults with severe mental illnesses such as schizophrenia, depression, and bipolar disorder, in higher-income countries. None of the studies included children or adolescents.  Primary outcomes We are uncertain whether SDM interventions improve clinical outcomes, such as psychiatric symptoms, depression, anxiety, and readmission, compared with control due to very low-certainty evidence. For readmission, we conducted subgroup analysis between studies that used usual care and those that used cognitive training in the control group. There were no subgroup differences. Regarding participation (by the person with the mental health condition) or level of involvement in the decision-making process, we are uncertain if SDM interventions improve observations on the process of SDM compared with no intervention due to very low-certainty evidence. On the other hand, SDM interventions may improve SDM-specific user-reported outcomes from encounters immediately after intervention compared with no intervention (standardised mean difference (SMD) 0.63, 95% confidence interval (CI) 0.26 to 1.01; 3 studies, 534 participants; low-certainty evidence). However, there was insufficient evidence for sustained participation or involvement in the decision-making processes. Secondary outcomes We are uncertain whether SDM interventions improve recovery compared with no intervention due to very low-certainty evidence. We are uncertain if SDM interventions improve users' overall satisfaction. However, one study (241 participants) showed that SDM interventions probably improve some aspects of users' satisfaction with received information compared with no intervention: information given was rated as helpful (risk ratio (RR) 1.33, 95% CI 1.08 to 1.65); participants expressed a strong desire to receive information this way for other treatment decisions (RR 1.35, 95% CI 1.08 to 1.68); and strongly recommended the information be shared with others in this way (RR 1.32, 95% CI 1.11 to 1.58). The evidence was of moderate certainty for these outcomes. However, this same study reported there may be little or no effect on amount or clarity of information, while another small study reported there may be little or no change in carer satisfaction with the SDM intervention. The effects of healthcare professional satisfaction were mixed: SDM interventions may have little or no effect on healthcare professional satisfaction when measured continuously, but probably improve healthcare professional satisfaction when assessed categorically. We are uncertain whether SDM interventions improve knowledge, treatment continuation assessed through clinic visits, medication continuation, carer participation, and the relationship between users and healthcare professionals because of very low-certainty evidence. Regarding length of consultation, SDM interventions probably have little or no effect compared with no intervention (SDM 0.09, 95% CI -0.24 to 0.41; 2 studies, 282 participants; moderate-certainty evidence). On the other hand, we are uncertain whether SDM interventions improve length of hospital stay due to very low-certainty evidence. There were no adverse effects on health outcomes and no other adverse events reported. AUTHORS' CONCLUSIONS: This review update suggests that people exposed to SDM interventions may perceive greater levels of involvement immediately after an encounter compared with those in control groups. Moreover, SDM interventions probably have little or no effect on the length of consultations.  Overall we found that most evidence was of low or very low certainty, meaning there is a generally low level of certainty about the effects of SDM interventions based on the studies assembled thus far. There is a need for further research in this area.

ACL reconstruction for all is not cost-effective after acute ACL rupture.

OBJECTIVES: To conduct a cost-utility analysis for two commonly used treatment strategies for patients after ACL rupture; early ACL reconstruction (index) versus rehabilitation plus an optional reconstruction in case of persistent instability (comparator). METHODS: Patients aged between 18 and 65 years of age with a recent ACL rupture (<2 months) were randomised between either an early ACL reconstruction (index) or a rehabilitation plus an optional reconstruction in case of persistent instability (comparator) after 3 months of rehabilitation. A cost-utility analysis was performed to compare both treatments over a 2-year follow-up. Cost-effectiveness was calculated as incremental costs per quality-adjusted life year (QALY) gained, using two perspectives: the healthcare system perspective and societal perspective. The uncertainty for costs and health effects was assessed by means of non-parametric bootstrapping. RESULTS: A total of 167 patients were included in the study, of which 85 were randomised to the early ACL reconstruction (index) group and 82 to the rehabilitation and optional reconstruction group (comparator). From the healthcare perspective it takes 48 460 € and from a societal perspective 78 179 €, to gain a QALY when performing early surgery compared with rehabilitation plus an optional reconstruction. This is unlikely to be cost-effective. CONCLUSION: Routine early ACL reconstruction (index) is not considered cost-effective as compared with rehabilitation plus optional reconstruction for a standard ACL population (comparator) given the maximum willingness to pay of 20 000 €/QALY. Early recognition of the patients that have better outcome of early ACL reconstruction might make rehabilitation and optional reconstruction even more cost-effective.

Dutch multidisciplinary guideline on Achilles tendinopathy.

OBJECTIVE: To provide a comprehensive, evidence-based overview of the risk factors, prevention, diagnosis, imaging, treatment and prognosis for Achilles tendinopathy. To make clinical recommendations for healthcare practitioners and patients. DESIGN: Comprehensive multidisciplinary guideline process funded by the Quality Foundation of the Dutch Federation of Medical Specialists. This process included a development, commentary and authorisation phase. Patients participated in every phase. DATA SOURCES: Multiple databases and existing guidelines were searched up to May 2019. Information from patients, healthcare providers and other stakeholders were obtained using a digital questionnaire, focus group interview and invitational conference. STUDY ELIGIBILITY CRITERIA: Studies on both insertional and/or midportion Achilles tendinopathy were eligible. Specific eligibility criteria were described per module. DATA EXTRACTION AND SYNTHESIS: To appraise the certainty of evidence, reviewers extracted data, assessed risk of bias and used the Grading of Recommendations Assessment, Development and Evaluation method, where applicable. Important considerations were: patient values and preferences, costs, acceptability of other stakeholders and feasibility of implementation. Recommendations were made based on the results of the evidence from the literature and the considerations. PRIMARY OUTCOME MEASURE: The primary and secondary outcome measures were defined per module and defined based on the input of patients obtained in collaboration with the Netherlands Patient Federation and healthcare providers from different professions. RESULTS: Six specific modules were completed: risk factors and primary prevention, diagnosis, imaging, treatment prognosis and secondary prevention for Achilles tendinopathy. SUMMARY/CONCLUSION: Our Dutch multidisciplinary guideline on Achilles tendinopathy provides six modules developed according to the standards of the Dutch Federation of Medical Specialists. Evidence-based recommendations for clinical practice are given for risk factors, prevention, diagnosis, imaging, treatment and prognosis. This guideline can assist healthcare providers and patients in clinical practice.

Enhancing respiratory sinus arrhythmia increases cardiac output in rats with left ventricular dysfunction.

KEY POINTS: Respiratory sinus arrhythmia is physiological pacing of the heart that disappears in cardiovascular disease and is associated with poor cardiac prognosis. In heart failure, cardiac pacing has little, if any, variation in rate at rest. We proposed that reinstatement of respiratory sinus arrhythmia would improve cardiac function in rats with heart failure. Heart failure rats were paced daily for 2 weeks with either respiratory sinus arrhythmia or paced monotonically at a matched heart rate; cardiac function was measured using non-invasive echocardiography. Cardiac output and stroke volume were increased in rats paced with respiratory sinus arrhythmia compared to monotonic pacing, via improvement in systolic function that persisted beyond the pacing treatment period. We propose that respiratory sinus arrhythmia pacing reverse-remodels the heart in heart failure and is worth considering as a new form of cardiac pacemaking. ABSTRACT: Natural pacing of the heart results in heart rate variability, an indicator of good health and cardiac function. A contributor to heart rate variability is respiratory sinus arrhythmia or RSA - an intrinsic respiratory modulated pacing of heart rate. The loss of RSA is associated with poor cardiac prognosis and sudden cardiac death. We tested if reinstatement of respiratory-modulated heart rate (RMH) would improve cardiac performance in heart failure. Heart failure was induced in Wistar rats by ligation of the left anterior descending coronary artery. Rats were unpaced, monotonically paced and RMH paced; the latter had the same average heart rate as the monotonically paced animals. Cardiac function was assessed non-invasively using echocardiography before and after 2 weeks of daily pacing at a time when pacing was turned off. RMH increased cardiac output by 20 ± 8% compared to monotonic pacing (-3 ± 5%; P < 0.05). This improvement in cardiac output was associated with an increase in stroke volume compared to monotonic pacing (P = 0.03) and improvement in circumferential strain (P = 0.02). Improvements in ejection fraction (P = 0.08) and surrogate measures of left ventricle compliance did not reach significance. Increases in contractility (P < 0.05) and coronary blood flow (P < 0.05) were seen in vitro during variable pacing to mimic RMH. Thus, in rats with left ventricular dysfunction, chronic RMH pacing improved cardiac function through improvements in systolic function. As these improvements were made with pacing switched off, we propose the novel idea that RMH pacing causes reverse-remodelling.

The barriers and facilitators influencing the sustainability of hospital-based interventions: a systematic review.

BACKGROUND: Identifying factors that influence sustained implementation of hospital-based interventions is key to ensuring evidence-based best practice is maintained across the NHS. This study aimed to identify, appraise and synthesise the barriers and facilitators that influenced the delivery of sustained healthcare interventions in a hospital-based setting. METHODS: A systematic review reported in accordance with PRISMA. Eight electronic databases were reviewed in addition to a hand search of Implementation Science journal and reference lists of included articles. Two reviewers were used to screen potential abstracts and full text papers against a selection criteria. Study quality was also independently assessed by two reviewers. Barriers and facilitators were extracted and mapped to a consolidated sustainability framework. RESULTS: Our searching identified 154,757 records. We screened 14,626 abstracts and retrieved 431 full text papers, of which 32 studies met the selection criteria. The majority of studies employed a qualitative design (23/32) and were conducted in the UK (8/32) and the USA (8/32). Interventions or programmes were all multicomponent, with the majority aimed at improving the quality of patient care and/ or safety (22/32). Sustainability was inconsistently reported across 30 studies. Barriers and facilitators were reported in all studies. The key facilitators included a clear accountability of roles and responsibilities (23/32); ensuring the availability of strong leadership and champions advocating the use of the intervention (22/32), and provision of adequate support available at an organisational level (21/32). The most frequently reported barrier to sustainability was inadequate staff resourcing (15/32). Our review also identified the importance of inwards spread and development of the initiative over time, as well as the unpredictability of sustainability and the need for multifaceted approaches. CONCLUSIONS: This review has important implications for practice and research as it increases understanding of the factors that faciliate and hinder intervention sustainability. It also highlights the need for more consistent and complete reporting of sustainability to ensure that lessons learned can be of direct benefit to future implementation of interventions. TRIAL REGISTRATION: The review is registered on PROSPERO ( CRD42017081992 ).

Facilitators and "deal breakers": a mixed methods study investigating implementation of the Goal setting and action planning (G-AP) framework in community rehabilitation teams.

BACKGROUND: High quality goal setting in stroke rehabilitation is vital, but challenging to deliver. The G-AP framework (including staff training and a stroke survivor held G-AP record) guides patient centred goal setting with stroke survivors in community rehabilitation teams. We found G-AP was acceptable, feasible to deliver and clinically useful in one team. The aim of this study was to conduct a mixed methods investigation of G-AP implementation in diverse community teams prior to a large-scale evaluation. METHODS: We approached Scottish community rehabilitation teams to take part. Following training, G-AP was delivered to stroke survivors within participating teams for 6 months. We investigated staff experiences of G-AP training and its implementation using focus groups and a training questionnaire. We investigated fidelity of G-AP delivery through case note review. Focus group data were analysed using a Framework approach; identified themes were mapped into Normalisation Process Theory constructs. Questionnaire and case note data were analysed descriptively. RESULTS: We recruited three teams comprising 55 rehabilitation staff. Almost all staff (93%, 51/55) participated in G-AP training; of those, 80% (n = 41/51) completed the training questionnaire. Training was rated as 'good' or 'very good' by almost all staff (92%, n = 37/41). G-AP was broadly implemented as intended in two teams. Implementation facilitators included - G-AP 'made sense'; repetitive use of G-AP in practice; flexible G-AP delivery and positive staff appraisals of G-AP impact. G-AP failed to gain traction in the third team. Implementation barriers included - delays between G-AP training and implementation; limited leadership engagement; a poor 'fit' between G-AP and the team organisational structure and simultaneous delivery of other goal setting methods. Staff recommended (i) development of training to include implementation planning; (ii) ongoing local implementation review and tailoring, and (iii) development of electronic and aphasia friendly G-AP records. CONCLUSIONS: The interaction between G-AP and the practice setting is critical to implementation success or failure. Whilst facilitators support implementation success, barriers can collectively act as implementation "deal breakers". Local G-AP implementation efforts should be planned, monitored and tailored. These insights can inform implementation of other complex interventions in community rehabilitation settings.

Implementing pelvic floor muscle training for women with pelvic organ prolapse: a realist evaluation of different delivery models.

BACKGROUND: Pelvic Floor Muscle Training (PFMT) has been shown to be effective for pelvic organ prolapse in women, but its implementation in routine practice is challenging due to lack of adequate specialist staff. It is important to know if PFMT can be delivered by different staff skill mixes, what barriers and facilitators operate in different contexts, what strategies enable successful implementation and what are the underlying mechanisms of their action. PROPEL intervention was designed to maximise the delivery of effective PFMT in the UK NHS using different staff skill mixes. We conducted a realist evaluation (RE) of this implementation to understand what works, for whom, in what circumstances and why. METHODS: Informed by the Realist and RE-AIM frameworks, the study used a longitudinal, qualitative, multiple case study design. The study took place in five, purposively selected, diverse NHS sites across the UK and proceeded in three phases to identify, test and refine a theory of change. Data collection took place at 4 time points over an 18 month implementation period using focus groups and semi-structured interviews with a range of stakeholders including service leads/managers, senior practitioners, newly trained staff and women receiving care in the new service models. Data were analysed using thematic framework approach adapted to identify Context, Mechanism and Outcome (CMO) configurations of the RE. RESULTS: A heightened awareness of the service need among staff and management was a mechanism for change, particularly in areas where there was a shortage of skilled staff. In contrast, the most established specialist physiotherapist-delivered PFMT service activated feelings of role protection and compromised quality, which restricted the reach of PFMT through alternative models. Staff with some level of prior knowledge in women's health and adequate organisational support were more comfortable and confident in new role. Implementation was seamless when PFMT delivery was incorporated in newly trained staff's role and core work. CONCLUSION: Roll-out of PFMT delivery through different staff skill mixes is possible when it is undertaken by clinicians with an interest in women's health, and carefully implemented ensuring adequate levels of training and ongoing support from specialists, multi-disciplinary teams and management.

Improving reporting of meta-ethnography: The eMERGe reporting guidance.

AIMS: The aim of this study was to provide guidance to improve the completeness and clarity of meta-ethnography reporting. BACKGROUND: Evidence-based policy and practice require robust evidence syntheses which can further understanding of people's experiences and associated social processes. Meta-ethnography is a rigorous seven-phase qualitative evidence synthesis methodology, developed by Noblit and Hare. Meta-ethnography is used widely in health research, but reporting is often poor quality and this discourages trust in and use of its findings. Meta-ethnography reporting guidance is needed to improve reporting quality. DESIGN: The eMERGe study used a rigorous mixed-methods design and evidence-based methods to develop the novel reporting guidance and explanatory notes. METHODS: The study, conducted from 2015 to 2017, comprised of: (1) a methodological systematic review of guidance for meta-ethnography conduct and reporting; (2) a review and audit of published meta-ethnographies to identify good practice principles; (3) international, multidisciplinary consensus-building processes to agree guidance content; (4) innovative development of the guidance and explanatory notes. FINDINGS: Recommendations and good practice for all seven phases of meta-ethnography conduct and reporting were newly identified leading to 19 reporting criteria and accompanying detailed guidance. CONCLUSION: The bespoke eMERGe Reporting Guidance, which incorporates new methodological developments and advances the methodology, can help researchers to report the important aspects of meta-ethnography. Use of the guidance should raise reporting quality. Better reporting could make assessments of confidence in the findings more robust and increase use of meta-ethnography outputs to improve practice, policy, and service user outcomes in health and other fields. This is the first tailored reporting guideline for meta-ethnography. This article is being simultaneously published in the following journals: Journal of Advanced Nursing, Psycho-oncology, Review of Education, and BMC Medical Research Methodology.

A methodological systematic review of meta-ethnography conduct to articulate the complex analytical phases.

BACKGROUND: Decision making in health and social care requires robust syntheses of both quantitative and qualitative evidence. Meta-ethnography is a seven-phase methodology for synthesising qualitative studies. Developed in 1988 by sociologists in education Noblit and Hare, meta-ethnography has evolved since its inception; it is now widely used in healthcare research and is gaining popularity in education research. The aim of this article is to provide up-to-date, in-depth guidance on conducting the complex analytic synthesis phases 4 to 6 of meta-ethnography through analysis of the latest methodological evidence. METHODS: We report findings from a methodological systematic review conducted from 2015 to 2016. Fourteen databases and five other online resources were searched. Expansive searches were also conducted resulting in inclusion of 57 publications on meta-ethnography conduct and reporting from a range of academic disciplines published from 1988 to 2016. RESULTS: Current guidance on applying meta-ethnography originates from a small group of researchers using the methodology in a health context. We identified that researchers have operationalised the analysis and synthesis methods of meta-ethnography - determining how studies are related (phase 4), translating studies into one another (phase 5), synthesising translations (phase 6) and line of argument synthesis - to suit their own syntheses resulting in variation in methods and their application. Empirical research is required to compare the impact of different methods of translation and synthesis. Some methods are potentially better at preserving links with the context and meaning of primary studies, a key principle of meta-ethnography. A meta-ethnography can and should include reciprocal and refutational translation and line of argument synthesis, rather than only one of these, to maximise the impact of its outputs. CONCLUSION: The current work is the first to articulate and differentiate the methodological variations and their application for different purposes and represents a significant advance in the understanding of the methodological application of meta-ethnography.

Improving reporting of meta-ethnography: the eMERGe reporting guidance.

AIMS: The aim of this study was to provide guidance to improve the completeness and clarity of meta-ethnography reporting. BACKGROUND: Evidence-based policy and practice require robust evidence syntheses which can further understanding of people's experiences and associated social processes. Meta-ethnography is a rigorous seven-phase qualitative evidence synthesis methodology, developed by Noblit and Hare. Meta-ethnography is used widely in health research, but reporting is often poor quality and this discourages trust in and use of its findings. Meta-ethnography reporting guidance is needed to improve reporting quality. DESIGN: The eMERGe study used a rigorous mixed-methods design and evidence-based methods to develop the novel reporting guidance and explanatory notes. METHODS: The study, conducted from 2015 to 2017, comprised of: (1) a methodological systematic review of guidance for meta-ethnography conduct and reporting; (2) a review and audit of published meta-ethnographies to identify good practice principles; (3) international, multidisciplinary consensus-building processes to agree guidance content; (4) innovative development of the guidance and explanatory notes. FINDINGS: Recommendations and good practice for all seven phases of meta-ethnography conduct and reporting were newly identified leading to 19 reporting criteria and accompanying detailed guidance. CONCLUSION: The bespoke eMERGe Reporting Guidance, which incorporates new methodological developments and advances the methodology, can help researchers to report the important aspects of meta-ethnography. Use of the guidance should raise reporting quality. Better reporting could make assessments of confidence in the findings more robust and increase use of meta-ethnography outputs to improve practice, policy, and service user outcomes in health and other fields. This is the first tailored reporting guideline for meta-ethnography. This article is being simultaneously published in the following journals: Journal of Advanced Nursing, Psycho-oncology, Review of Education, and BMC Medical Research Methodology.

Women's experiences of receiving care for pelvic organ prolapse: a qualitative study.

BACKGROUND: Pelvic organ prolapse is a common urogenital condition affecting 41-50% of women over the age of 40. To achieve early diagnosis and appropriate treatment, it is important that care is sensitive to and meets women's needs, throughout their patient journey. This study explored women's experiences of seeking diagnosis and treatment for prolapse and their needs and priorities for improving person-centred care. METHODS: Twenty-two women receiving prolapse care through urogynaecology services across three purposefully selected NHS UK sites took part in three focus groups and four telephone interviews. A topic guide facilitated discussions about women's experiences of prolapse, diagnosis, treatment, follow-up, interactions with healthcare professionals, overall service delivery, and ideals for future services to meet their needs. Data were analysed thematically. RESULTS: Three themes emerged relating to women's experiences of a) Evaluating what is normal b) Hobson's choice of treatment decisions, and c) The trial and error of treatment and technique. Women often delayed seeking help for their symptoms due to lack of awareness, embarrassment and stigma. When presented to GPs, their symptoms were often dismissed and unaddressed until they became more severe. Women reported receiving little or no choice in treatment decisions. Choices were often influenced by health professionals' preferences which were subtly reflected through the framing of the offer. Women's embodied knowledge of their condition and treatment was largely unheeded, resulting in decisions that were inconsistent with women's preferences and needs. Physiotherapy based interventions were reported as helping women regain control over their symptoms and life. A need for greater awareness of prolapse and physiotherapy interventions among women, GPs and consultants was identified alongside greater focus on prevention, early diagnosis and regular follow-up. Greater choice and involvement in treatment decision making was desired. CONCLUSIONS: As prolapse treatment options expand to include more conservative choices, greater awareness and education is needed among women and professionals about these as a first line treatment and preventive measure, alongside a multi-professional team approach to treatment decision making. Women presenting with prolapse symptoms need to be listened to by the health care team, offered better information about treatment choices, and supported to make a decision that is right for them.

Improving reporting of meta-ethnography: The eMERGe reporting guidance.

AIMS: The aim of this study was to provide guidance to improve the completeness and clarity of meta-ethnography reporting. BACKGROUND: Evidence-based policy and practice require robust evidence syntheses which can further understanding of people's experiences and associated social processes. Meta-ethnography is a rigorous seven-phase qualitative evidence synthesis methodology, developed by Noblit and Hare. Meta-ethnography is used widely in health research, but reporting is often poor quality and this discourages trust in and use of its findings. Meta-ethnography reporting guidance is needed to improve reporting quality. DESIGN: The eMERGe study used a rigorous mixed-methods design and evidence-based methods to develop the novel reporting guidance and explanatory notes. METHODS: The study, conducted from 2015 - 2017, comprised of: (1) a methodological systematic review of guidance for meta-ethnography conduct and reporting; (2) a review and audit of published meta-ethnographies to identify good practice principles; (3) international, multidisciplinary consensus-building processes to agree guidance content; (4) innovative development of the guidance and explanatory notes. FINDINGS: Recommendations and good practice for all seven phases of meta-ethnography conduct and reporting were newly identified leading to 19 reporting criteria and accompanying detailed guidance. CONCLUSION: The bespoke eMERGe Reporting Guidance, which incorporates new methodological developments and advances the methodology, can help researchers to report the important aspects of meta-ethnography. Use of the guidance should raise reporting quality. Better reporting could make assessments of confidence in the findings more robust and increase use of meta-ethnography outputs to improve practice, policy, and service user outcomes in health and other fields. This is the first tailored reporting guideline for meta-ethnography. This article is being simultaneously published in the following journals: Journal of Advanced Nursing, Psycho-oncology, Review of Education, and BMC Medical Research Methodology.

Safety and long-term effectiveness of paroxysmal atrial fibrillation ablation with a contact force-sensing catheter: real-world experience from a prospective, multicentre observational cohort registry.

Aims: Real-time contact force (CF)-sensing radiofrequency ablation catheter for treatment of paroxysmal atrial fibrillation (PAF) allows optimization of electrode-tissue contact, which correlates with long-term success. This prospective, multicentre observational registry assessed the real-world clinical effectiveness of a CF-sensing catheter for ablation of drug-refractory PAF. Methods and results: Patients were followed-up at 3, 6, and 12 months after ablation. Outcome measures included isolation of targeted pulmonary veins (PVs) confirmed by entrance block (acute success), patient-reported freedom from symptomatic atrial fibrillation (AF) at 12 months (long-term effectiveness), Atrial Fibrillation Effect on Quality-of-life scores at 6 and 12 months, and incidence of predefined procedural complications. The registry enrolled 261 PAF patients (mean age 58.8 ± 11.3 years; 70.7% men; 91.7% Caucasian). Acute PV isolation was reported in 98.8% of patients [95% confidence interval (CI): 96.4-99.7%], and 12-month success for freedom from symptomatic AF was 75.7% (95% CI: 69.7-80.7%). Average CF for the evaluable cohort was 16.4 ± 3.9 g. There was a significant correlation between long-term effectiveness and stability of CF use [percentage of time CF was within investigator-selected working range; odds ratio (95% Wald CI), 1.0 (1.00-1.1); P = 0.030]. Average CF did not correlate with 12-month success. Clinically meaningful quality of life (QoL) improvements were observed at 6 and 12 months. Primary adverse events occurred in 2.7% patients. Conclusion: This observational registry showed that PAF ablation with a CF-sensing catheter had high acute success rates, favourable 12-month outcomes, and a good safety profile. Patients' QoL improved significantly. Long-term effectiveness significantly correlated with stable CF with adequate catheter-tissue contact (NCT01677052).

Patient-centred goal setting in a hospice: a comparative case study of how health practitioners understand and use goal setting in practice.

BACKGROUND: Goal setting is recognised as an important way of supporting people to live as actively as possible until death. However, there is little agreement about how goal setting should be handled or delivered by health professionals in everyday practice. AIM: To investigate health-care practitioners' understanding and practice of patient-centred goal setting in a hospice. METHODS: A comparative case study of 10 healthcare practitioners in one hospice. Non-participant observations (n=28), semi-structured interviews (n=10) and case-note analysis (n=67) were undertaken. Data were analysed using framework analysis. RESULTS: Participants viewed goal setting as part of routine practice. However, goal setting focused around what was seen as important from the health practitioner's perspective, rather than being patient-centred. Participants' goal-setting practice was implicit and opportunities to support patients to pursue goals were missed. Participants emphasised problem solving and alleviating symptoms rather than focusing on patient priorities and establishing patient-centred goals. CONCLUSION: While goal setting is valued, it is practiced in an implicit, practitioner-centred and inconsistent manner. A more explicit, person-centred goal setting process may support practitioners more consistently in helping patients to identify their priorities and enhance their quality of life.

Increasing age does not affect time to appropriate therapy in primary prevention ICD/CRT-D: a competing risks analysis.

Aims: To evaluate the impact of age on the clinical outcomes in a primary prevention implantable cardioverter defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) population. Methods and Results: A retrospective, multicentre analysis of patients aged 60 years and over with primary prevention ICD/CRT-D devices implanted between 1 January 2006 and 1 November 2014 was performed. Survival to follow-up with no therapy (T1), death prior to follow-up with no therapy (T2), delivery of appropriate therapy with survival to follow-up (T3), and delivery of appropriate therapy with death prior to follow-up (T4) were measured. In total, 424 patients were eligible for inclusion in the analysis, mean follow-up of 32.6 months during which time 44 patients (10.1%) received appropriate therapy. The sub-hazard ratio (SHR) for the cumulative incidence of appropriate therapy (T3) according to age at implant was 1.00 (P = 0.851; 95% CI 0.96­1.04). The SHR for cumulative incidence of death (T2) according to age at implant was 1.06 (P < 0.001; 95% CI 1.03­1.01). Age at implant, ischaemic aetiology, baseline haemoglobin, and the presence of diabetes mellitus were predictors of all-cause mortality. Conclusion: Age has no impact on the time to appropriate therapy, but risk of death prior to therapy increases by 6% for every year increment. As the ICD population ages, the proportion who die without receiving appropriate therapy increases due to competing risks. Characterizing competing risks predictive of death independent of ICD indication would focus therapy on those with potential to benefit and reduce unnecessary exposure to ICD-related morbidity.

Safety and mid-term outcome of catheter ablation of ventricular tachycardia in octogenarians.

AIMS: Radiofrequency (RF) catheter ablation (CA) is superior to standard medical therapy in controlling recurrent ventricular tachycardia (VT). The majority of procedures have been performed in a middle-aged population. The outcome of VT ablation in the elderly has not been described. METHODS AND RESULTS: We retrospectively studied the outcome and safety of CA of VT in octogenarians performed in four European centres. The population consisted of patients presenting with recurrent VT refractory to medical therapy. Patients aged over 80 years were compared with younger patients undergoing CA. Clinical characteristics, procedural data, complications, and outcomes were examined. Implantable cardioverter-defibrillator (ICD) therapy data were collected. A total of 54 consecutive octogenarian patients underwent RF CA of VT and represented the study group (42 males, age 82.8 ± 2.7 years) compared with a control group of 104 younger patients (85 males, age 66.7 ± 8.9 years). Mean follow-up was 33 ± 48 months. Implantable cardioverter-defibrillators were present in 81 and 86% of patients, respectively (P = 0.93). Left ventricular ejection fraction was 29% ± 8.2 in octogenarians vs. 34% ± 10.2 in the younger group (P < 0.01). More major complications occurred in octogenarians (18 vs. 2%, P < 0.01). During follow-up, there were more ICD shocks in the octogenarians (28 vs. 15%, P < 0.01). The Kaplan-Meier curve of survival after VT ablation confirms comparable survival rates at 1 year, but the elderly have poor survival in the mid-term. Survival in the elderly post VT ablation is comparable with that in an age-matched cohort with ICDs but no VT storm. CONCLUSION: Octogenarians undergoing CA of VT have more risk factors, higher risk of complications and ICD shocks, but demonstrate comparable short-term survival rates.

Cardiac resynchronization therapy: mechanisms of action and scope for further improvement in cardiac function.

AIMS: Cardiac resynchronization therapy (CRT) may exert its beneficial haemodynamic effect by improving ventricular synchrony and improving atrioventricular (AV) timing. The aim of this study was to establish the relative importance of the mechanisms through which CRT improves cardiac function and explore the potential for additional improvements with improved ventricular resynchronization. METHODS AND RESULTS: We performed simulations using the CircAdapt haemodynamic model and performed haemodynamic measurements while adjusting AV delay, at low and high heart rates, in 87 patients with CRT devices. We assessed QRS duration, presence of fusion, and haemodynamic response. The simulations suggest that intrinsic PR interval and the magnitude of reduction in ventricular activation determine the relative importance of the mechanisms of benefit. For example, if PR interval is 201 ms and LV activation time is reduced by 25 ms (typical for current CRT methods), then AV delay optimization is responsible for 69% of overall improvement. Reducing LV activation time by an additional 25 ms produced an additional 2.6 mmHg increase in blood pressure (30% of effect size observed with current CRT). In the clinical population, ventricular fusion significantly shortened QRS duration (Δ-27 ± 23 ms, P < 0.001) and improved systolic blood pressure (mean 2.5 mmHg increase). Ventricular fusion was present in 69% of patients, yet in 40% of patients with fusion, shortening AV delay (to a delay where fusion was not present) produced the optimal haemodynamic response. CONCLUSIONS: Improving LV preloading by shortening AV delay is an important mechanism through which cardiac function is improved with CRT. There is substantial scope for further improvement if methods for delivering more efficient ventricular resynchronization can be developed. CLINICAL TRIAL REGISTRATION: Our clinical data were obtained from a subpopulation of the British Randomised Controlled Trial of AV and VV Optimisation (BRAVO), which is a registered clinical trial with unique identifier: NCT01258829, https://clinicaltrials.gov.