'You can't start a car when there's no petrol left': a qualitative study of patient, family and clinician perspectives on implantable cardioverter defibrillator deactivation.

OBJECTIVE: To explore the attitudes towards implantable cardioverter defibrillator (ICD) deactivation and initiation of deactivation discussions among patients, relatives and clinicians. DESIGN: A multiphase qualitative study consisting of in situ hospital ICD clinic observations, and semistructured interviews of clinicians, patients and relatives. Data were analysed using a constant comparative approach. SETTING: One tertiary and two district general hospitals in England. PARTICIPANTS: We completed 38 observations of hospital consultations prior to ICD implantation, and 80 interviews with patients, family members and clinicians between 2013 and 2015. Patients were recruited from preimplantation to postdeactivation. Clinicians included cardiologists, cardiac physiologists, heart failure nurses and palliative care professionals. RESULTS: Four key themes were identified from the data: the current status of deactivation discussions; patients' perceptions of deactivation; who should take responsibility for deactivation discussions and decisions; and timing of deactivation discussions. We found that although patients and doctors recognised the importance of advance care planning, including ICD deactivation at an early stage in the patient journey, this was often not reflected in practice. The most appropriate clinician to take the lead was thought to be dependent on the context, but could include any appropriately trained member of the healthcare team. It was suggested that deactivation should be raised preimplantation and regularly reviewed. Identification of trigger points postimplantation for deactivation discussions may help ensure that these are timely and inappropriate shocks are avoided. CONCLUSIONS: There is a need for early, ongoing and evolving discussion between ICD recipients and clinicians regarding the eventual need for ICD deactivation. The most appropriate clinician to instigate deactivation discussions is likely to vary between patients and models of care. Reminders at key trigger points, and routine discussion of deactivation at implantation and during advance care planning could prevent distressing experiences for both the patient and their family at the end of life.

The effectiveness of using the workplace to identify and address modifiable health risk factors in deprived populations.

OBJECTIVES: To establish whether a programme of targeted health screening, with referral to appropriate interventions, offered to an employed but socioeconomically deprived group was effective in overcoming barriers to uptake of such services and improving a range of surrogate health markers for participants. METHODS: Low-paid local government employees from socially and economically deprived areas in North-East England were invited to attend a free health check. Health checks were conducted within working hours and close to their worksite, and included assessment of a range of lifestyle and health-related risk factors, including those associated with cardiovascular disease (CVD). A range of additional interventions were offered where indicated. Participants were invited to repeat screening approximately 9 months later. RESULTS: 635 (20% response rate) employees in the target age group (≥40 years) attended the first check. Most health risk markers improved in those (N=427) attending both health checks, as did the mean CVD risk score (t=2.86, p=0.004). 269 referrals were made to the intervention programmes. CONCLUSIONS: This workplace programme had a positive impact on cardiovascular health, but attendance rates were low. These findings suggest that workplace health screening activities may have the potential to improve health in a group often considered hard to reach by other routes, but do not offer a straightforward solution in overcoming barriers to access for such subgroups within the working population.

Patients or volunteers? The impact of motivation for trial participation on the efficacy of patient decision Aids: a secondary analysis of a Cochrane systematic review.

BACKGROUND: Efficacy of patient decision aids (PtDAs) may be influenced by trial participants' identity either as patients seeking to benefit personally from involvement or as volunteers supporting the research effort. AIM: To determine if study characteristics indicative of participants' trial identity might influence PtDA efficacy. METHODS: We undertook exploratory subgroup meta-analysis of the 2011 Cochrane review of PtDAs, including trials that compared PtDA with usual care for treatment decisions. We extracted data on whether participants initiated the care pathway, setting, practitioner interactions, and 6 outcome variables (knowledge, risk perception, decisional conflict, feeling informed, feeling clear about values, and participation). The main subgroup analysis categorized trials as "volunteerism" or "patienthood" on the basis of whether participants initiated the care pathway. A supplementary subgroup analysis categorized trials on the basis of whether any volunteerism factors were present (participants had not initiated the care pathway, had attended a research setting, or had a face-to-face interaction with a researcher). RESULTS: Twenty-nine trials were included. Compared with volunteerism trials, pooled effect sizes were higher in patienthood trials (where participants initiated the care pathway) for knowledge, decisional conflict, feeling informed, feeling clear, and participation. The subgroup difference was statistically significant for knowledge only (P = 0.03). When trials were compared on the basis of whether volunteerism factors were present, knowledge was significantly greater in patienthood trials (P < 0.001), but there was otherwise no consistent pattern of differences in effects across outcomes. CONCLUSIONS: There is a tendency toward greater PtDA efficacy in trials in which participants initiate the pathway of care. Knowledge acquisition appears to be greater in trials where participants are predominantly patients rather than volunteers.

An external pilot study to test the feasibility of a randomised controlled trial comparing eye muscle surgery against active monitoring for childhood intermittent exotropia [X(T)].

INTRODUCTION: The evidence base for the treatment of strabismus (squint) is poor. Our main aim is to improve this evidence base for the treatment of a common type of childhood squint {intermittent exotropia, [X(T)]}. We conducted an external pilot study in order to inform the design and conduct of a future full randomised controlled trial (RCT). METHODS: Children of between 6 months and 16 years with a recent diagnosis of X(T) were eligible for recruitment. Participants were recruited from secondary care at the ophthalmology departments at four UK NHS foundation trusts. Participants were randomised to either active monitoring or surgery. This report describes the findings of the Pilot Rehearsal Trial and Qualitative Study, and assesses the success against the objectives proposed. RECRUITMENT AND RETENTION: The experience gained during the Pilot Rehearsal Trial demonstrates the ability to recruit and retain sites that are willing to randomise children to both trial arms, and for parents to agree to randomisation of their children to such a study. One child declined the group allocation. A total of 231 children were screened (expected 240), of whom 138 (60%) were eligible (expected 228: 95%) and 49 (35% of eligible) children were recruited (expected 144: 63% of eligible). Strategies that improved recruitment over the course of the trial are discussed, together with the reasons why fewer children were eligible for recruitment than initially anticipated. Attrition was low. Outcome data were obtained for 47 of 49 randomised children. TRIAL PROCESSES AND DATA COLLECTION: The Trial Management processes proved effective. There were high levels of completion on all of the data collection forms. However, the feedback from the treatment orthoptists revealed that some modifications should be made to the length and frequency of the health service assessment and travel assessment questionnaires, thus reducing the burden on participants in the main trial. Modifications to the wording of the questions also need to be made. MONITORING OF BIAS: Children who recruited to the trial were older and had more severe strabismus than those children eligible but declining participation. Strategies to account for this in a full trial are proposed. REASONS FOR PARTICIPATION OR DECLINING STUDY: These were identified using qualitative interviews. The principal reasons for declining entry into the study were strong preferences for and against surgical treatment. HARMS: There were no serious unexpected adverse events. Two children had overcorrection of their X(T) with reduction in binocular vision following surgery, which is in line with previous studies. No children in the active monitoring arm developed a constant strabismus although two showed some reduction in control. CONCLUSIONS: The SamExo study has demonstrated that it is possible to recruit and retain participants to a randomised trial of surgery compared with active monitoring for X(T). For longer-term full RCTs, in order to maximise the generalisability of future studies, consideration needs to be given to planning more time and clinic appointments to assess eligibility and to allow consideration of participation; the greater use of research nurses for recruitment; and accommodating the strong preferences of some parents both for and against surgical intervention. TRIAL REGISTRATION: Current Controlled Trials ISRCTN44114892. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 39. See the NIHR Journals Library website for further project information.

A systematic review of the effectiveness of treatments in altering the natural history of intermittent exotropia.

Evidence of effectiveness of interventions for treatment of childhood intermittent exotropia, X(T), is unclear. We conducted a systematic review to locate, appraise and synthesise evidence of effectiveness, including twelve electronic databases, supplemented with hand searches and expert contact. We included randomised controlled trials, quasi-experimental and cohort studies with a comparison group examining interventions for divergence excess, simulated divergence excess or basic type X(T) in children, up to and including 18 years of age, followed for at least 6 months. Dual data extraction and critical appraisal were conducted and a narrative synthesis undertaken. Eleven studies satisfied the eligibility criteria. Seven examined the comparative effectiveness of two surgical procedures; four compared surgery with other interventions, including botulinum toxin A therapy, orthoptic exercises, occlusion, binocular vision training and watchful waiting. The evidence retrieved was of limited extent and quality with differences across studies in terms of outcome assessment and most appropriate time-point for measuring long-term outcomes. There were mixed outcomes when comparing unilateral recession/resection (R&R) with bilateral lateral rectus recession (BLR) on improving angle of deviation, which makes it difficult to recommend either surgical option with confidence. While non-surgical interventions appear less effective in terms of improving angle of deviation, they are rarely associated with adverse outcomes. Given the limited evidence base, better designed studies are required to address the question of the most effective management for treatment of childhood X(T). Importantly, consensus is required on what constitutes a successful outcome as well as agreement on how this should be measured.

Understanding clinicians' decisions to offer intravenous thrombolytic treatment to patients with acute ischaemic stroke: a protocol for a discrete choice experiment.

BACKGROUND: Intravenous thrombolysis is an effective emergency treatment for acute ischaemic stroke for patients meeting specific criteria. Approximately 12% of eligible patients in England, Wales and Northern Ireland received thrombolysis in the first quarter of 2013, yet as many as 15% are eligible to receive treatment. Suboptimal use of thrombolysis may have been largely attributable to structural factors; however, with the widespread implementation of 24/7 hyper acute stroke services, continuing variation is likely to reflect differences in clinical decision-making, in particular the influence of ambiguous areas within the guidelines, licensing criteria and research evidence. Clinicians' perceptions about thrombolysis may now exert a greater influence on treatment rates than structural/service factors. This research seeks to elucidate factors influencing thrombolysis decision-making by using patient vignettes to identify (1) patient-related and clinician-related factors that may help to explain variation in treatment and (2) associated trade-offs in decision-making based on the interplay of critical factors. METHODS/ANALYSIS: A discrete choice experiment (DCE) will be conducted to better understand how clinicians make decisions about whether or not to offer thrombolysis to patients with acute ischaemic stroke. To inform the design, exploratory work will be undertaken to ensure that (1) all potentially influential factors are considered for inclusion; and (2) to gain insights into the 'grey areas' of patient factors. A fractional factorial design will be used to combine levels of patient factors in vignettes, which will be presented to clinicians to allow estimation of the variable effects on decisions to offer thrombolysis. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the Newcastle University Research Ethics Committee. The results will be disseminated in peer review publications and at national conferences. Findings will be translated into continuing professional development activities and will support implementation of a computerised decision aid for thrombolysis (COMPASS) in acute stroke care.

Incorporating the patient perspective: a critical review of clinical practice guidelines for implantable cardioverter defibrillator therapy.

PURPOSE: Implantable cardioverter defibrillators (ICDs) are recommended for patients with heart failure and/or ventricular arrhythmias at risk of sudden cardiac death. Guidelines for ICD implantation are derived from robust clinical data. However, critical factors which might influence treatment decisions include patient preferences. We set out to determine how clinical practice guidelines (CPGs) incorporate the patient perspective into supporting decision making about ICDs. METHODS: CPGs on ICD implantation were purposively selected from national and professional bodies in Europe, North America and Australasia. CPGs were then appraised according to three key domains of shared decision making: (a) informing patients about the risks, benefits and consequences known to be important to patients; (b) personalising risks and benefits and (c) involvement of patient (plus family/significant others if desired) in decision making. RESULTS: Appraisal of six current CPGs found major deficiencies or inconsistencies in guidance. CPGs tended to focus on evidence of device effectiveness, with sparse consideration of other outcomes important to patients such as impacts on quality of life and psychosocial well-being. Little reference was made to involvement of the patient in decision making. CONCLUSIONS: This suggests that embedding shared decision in CPGs will improve the patient-centeredness of ICD treatment by enabling patients to make informed, value-based decisions. Specific recommendations for CPG development include the need for signposting to preference sensitive decision points as well as inclusion of a broader range of outcomes which are known to be important to patients when deciding whether or not to have a device fitted.

Reducing health inequalities in priority public health conditions: using rapid review to develop proposals for evidence-based policy.

BACKGROUND: In November 2008, the Secretary of State for Health (England) commissioned an independent review to propose effective strategies for reducing health inequalities. Review task groups were given just 3 months to make preliminary evidence-based recommendations. In this paper, we describe the methodology used, and the recommendations made, by the group tasked with inequalities in priority public health conditions. METHODS: A series of rapid literature reviews of the policy-relevant international evidence base was undertaken. Quantitative studies of any design, which looked at the effects on health inequalities, the social gradient or overall population health effects, of interventions designed to address the social determinants of selected public health priority conditions were examined. Recommendations were distilled using a Delphi approach. RESULTS: Five key policy proposals were made: reduce smoking in the most deprived groups; improve availability of and access to healthier food choices amongst low income groups; improve the early detection and treatment of diseases; introduce a minimum price per unit for alcohol and improve the links between physical and mental health care. CONCLUSION: The combination of rapid review and Delphi distillation produced a shortlist of evidence-based recommendations within the allocated time frame. There was a dearth of robust evidence on the effectiveness and cost-effectiveness of the interventions we examined: our proposals had to be based on extrapolation from general population health effects. Extensive, specific and robust evidence is urgently needed to guide policy and programmes. In the meantime, our methodology provides a reasonably sound and pragmatic basis for evidence-based policy-making.

Flexible working conditions and their effects on employee health and wellbeing.

BACKGROUND: Flexible working conditions are increasingly popular in developed countries but the effects on employee health and wellbeing are largely unknown. OBJECTIVES: To evaluate the effects (benefits and harms) of flexible working interventions on the physical, mental and general health and wellbeing of employees and their families. SEARCH STRATEGY: Our searches (July 2009) covered 12 databases including the Cochrane Public Health Group Specialised Register, CENTRAL; MEDLINE; EMBASE; CINAHL; PsycINFO; Social Science Citation Index; ASSIA; IBSS; Sociological Abstracts; and ABI/Inform. We also searched relevant websites, handsearched key journals, searched bibliographies and contacted study authors and key experts. SELECTION CRITERIA: Randomised controlled trials (RCT), interrupted time series and controlled before and after studies (CBA), which examined the effects of flexible working interventions on employee health and wellbeing. We excluded studies assessing outcomes for less than six months and extracted outcomes relating to physical, mental and general health/ill health measured using a validated instrument. We also extracted secondary outcomes (including sickness absence, health service usage, behavioural changes, accidents, work-life balance, quality of life, health and wellbeing of children, family members and co-workers) if reported alongside at least one primary outcome. DATA COLLECTION AND ANALYSIS: Two experienced review authors conducted data extraction and quality appraisal. We undertook a narrative synthesis as there was substantial heterogeneity between studies. MAIN RESULTS: Ten studies fulfilled the inclusion criteria. Six CBA studies reported on interventions relating to temporal flexibility: self-scheduling of shift work (n = 4), flexitime (n = 1) and overtime (n = 1). The remaining four CBA studies evaluated a form of contractual flexibility: partial/gradual retirement (n = 2), involuntary part-time work (n = 1) and fixed-term contract (n = 1). The studies retrieved had a number of methodological limitations including short follow-up periods, risk of selection bias and reliance on largely self-reported outcome data. Four CBA studies on self-scheduling of shifts and one CBA study on gradual/partial retirement reported statistically significant improvements in either primary outcomes (including systolic blood pressure and heart rate; tiredness; mental health, sleep duration, sleep quality and alertness; self-rated health status) or secondary health outcomes (co-workers social support and sense of community) and no ill health effects were reported. Flexitime was shown not to have significant effects on self-reported physiological and psychological health outcomes. Similarly, when comparing individuals working overtime with those who did not the odds of ill health effects were not significantly higher in the intervention group at follow up. The effects of contractual flexibility on self-reported health (with the exception of gradual/partial retirement, which when controlled by employees improved health outcomes) were either equivocal or negative. No studies differentiated results by socio-economic status, although one study did compare findings by gender but found no differential effect on self-reported health outcomes. AUTHORS' CONCLUSIONS: The findings of this review tentatively suggest that flexible working interventions that increase worker control and choice (such as self-scheduling or gradual/partial retirement) are likely to have a positive effect on health outcomes. In contrast, interventions that were motivated or dictated by organisational interests, such as fixed-term contract and involuntary part-time employment, found equivocal or negative health effects. Given the partial and methodologically limited evidence base these findings should be interpreted with caution. Moreover, there is a clear need for well-designed intervention studies to delineate the impact of flexible working conditions on health, wellbeing and health inequalities.

The place and practices of well-being in local governance.

The concept of well-being has become prominent within national policy goals in the UK since the end of the 1990s. However, the concept of well-being remains ill defined, an instability that is increasingly understood as problematic to policy making. We engage with this terminological instability through an exploration of how the concept of well-being is practised discursively in local governance and critically examine the place of the concept in local policy making. In contrast to the current enthusiasm to define and measure well-being, we argue that the conceptual instability has inherent value for local governance. The concept of well-being is practised through a number of potentially conflicting discourses, but it is exactly this conceptual instability that enables a local negotiation and combination of alternative policy frameworks for local place-shaping strategies. As such, well-being not only is an overarching goal of governance but also contributes to the dynamics of the policy process.

"To me it's just another tool to help understand the evidence": public health decision-makers' perceptions of the value of geographical information systems (GIS).

While geographical information systems (GIS) have applications in a range of diverse fields, they remain underused by decision-makers in health settings. Through analysis of data captured in semi-structured interviews, the paper explores four thematic areas (the ontological, power, functionality and collaboration discourses) to understand how GIS are perceived and valued by public health decision-makers. The findings suggest that although GIS are viewed as useful tools to inform decision-making, they are in no way a panacea for practice. Participants' concerns that GIS outputs can potentially be misinterpreted or used erroneously might partly explain resistance to their use. GIS are, therefore, likely to be most effective in decision-making when applied in a multi-disciplinary context to facilitate sharing of data, knowledge and expertise across the public health landscape.

Risk factors for pediatric invasive pneumococcal disease in the Intermountain West, 1996-2002.

PURPOSE: In response to concerns that the epidemiology of pediatric invasive pneumococcal disease (IPD) in the Intermountain West (i.e., Utah, Idaho, Wyoming, Montana, and parts of Arizona and Nevada) was poorly understood and might differ from elsewhere in the United States, a case-control study was undertaken to determine factors associated with IPD during 1996-2002. METHODS: A telephone questionnaire was administered to parents of children comprising 120 cases identified through hospital records and to parents of 156 age-matched controls located by random-digit dialing. The unit of analysis was each matched case-control set. RESULTS: Underlying chronic illness was reported for 32 (27%) of the cases. For previously healthy children, breastfeeding had a protective benefit (adjusted odds ratio: 0.2; 95% confidence interval [CI], 0.1-0.6), while a history of tympanostomy tube surgery was a risk factor (adjusted odds ratio: 12.6; 95% CI, 1.5-107.3). CONCLUSIONS: The presence of an underlying chronic illness was the strongest risk factor for IPD. Except for a history of tympanostomy tube surgery, the factors associated with IPD in this investigation were similar to those reported from other geographic regions. Tympanostomy surgery might serve as a surrogate indicator for predisposition to recurrent otitis media or decreased ability to clear pneumococcal infection, raising risk for invasive disease. Pediatric clinicians should continue to encourage breastfeeding, and continued emphasis on pneumococcal vaccination should help prevent IPD.