Quality improvement interventions to increase the uptake of magnesium sulphate in preterm deliveries for the prevention of cerebral palsy (PReCePT study): a cluster randomised controlled trial.

OBJECTIVE: To compare two quality improvement (QI) interventions to improve antenatal magnesium sulphate (MgSO4 ) uptake in preterm births for the prevention of cerebral palsy. DESIGN: Unblinded cluster randomised controlled trial. SETTING: Academic Health Sciences Network, England, 2018. SAMPLE: Maternity units with ≥10 preterm deliveries annually and MgSO4 uptake of ≤70%; 40 (27 NPP, 13 enhanced support) were included (randomisation stratified by MgSO4 uptake). METHODS: The National PReCePT Programme (NPP) gave maternity units QI materials (clinical guidance, training), regional support, and midwife backfill funding. Enhanced support units received this plus extra backfill funding and unit-level QI coaching. MAIN OUTCOME MEASURES: MgSO4 uptake was compared using routine data and multivariable linear regression. Net monetary benefit was estimated, based on implementation costs, lifetime quality-adjusted life-years and societal costs. The implementation process was assessed through qualitative interviews. RESULTS: MgSO4 uptake increased in all units, with no evidence of any difference between groups (0.84 percentage points lower uptake in the enhanced group, 95% CI -5.03 to 3.35). The probability of enhanced support being cost-effective was <30%. NPP midwives gave more than their funded hours for implementation. Units varied in their support needs. Enhanced support units reported better understanding, engagement and perinatal teamwork. CONCLUSIONS: PReCePT improved MgSO4 uptake in all maternity units. Enhanced support did not further improve uptake but may improve teamwork, and more accurately represented the time needed for implementation. Targeted enhanced support, sustainability of improvements and the possible indirect benefits of stronger teamwork associated with enhanced support should be explored further.

The effectiveness of knowledge-sharing techniques and approaches in research funded by the National Institute for Health and Care Research (NIHR): a systematic review.

BACKGROUND: The National Institute of Health and Care Research (NIHR), funds, enables and delivers world-leading health and social care research to improve people's health and wellbeing. To achieve this aim, effective knowledge sharing (two-way knowledge sharing between researchers and stakeholders to create new knowledge and enable change in policy and practice) is needed. To date, it is not known which knowledge sharing techniques and approaches are used or how effective these are in creating new knowledge that can lead to changes in policy and practice in NIHR funded studies. METHODS: In this restricted systematic review, electronic databases [MEDLINE, The Health Management Information Consortium (including the Department of Health's Library and Information Services and King's Fund Information and Library Services)] were searched for published NIHR funded studies that described knowledge sharing between researchers and other stakeholders. One researcher performed title and abstract, full paper screening and quality assessment (Critical Appraisal Skills Programme qualitative checklist) with a 20% sample independently screened by a second reviewer. A narrative synthesis was adopted. RESULTS: In total 9897 records were identified. After screening, 17 studies were included. Five explicit forms of knowledge sharing studies were identified: embedded models, knowledge brokering, stakeholder engagement and involvement of non-researchers in the research or service design process and organisational collaborative partnerships between universities and healthcare organisations. Collectively, the techniques and approaches included five types of stakeholders and worked with them at all stages of the research cycle, except the stage of formation of the research design and preparation of funding application. Seven studies (using four of the approaches) gave examples of new knowledge creation, but only one study (using an embedded model approach) gave an example of a resulting change in practice. The use of a theory, model or framework to explain the knowledge sharing process was identified in six studies. CONCLUSIONS: Five knowledge sharing techniques and approaches were reported in the included NIHR funded studies, and seven studies identified the creation of new knowledge. However, there was little investigation of the effectiveness of these approaches in influencing change in practice or policy.

'Sadly I think we are sort of still quite white, middle-class really' - Inequities in access to bereavement support: Findings from a mixed methods study.

BACKGROUND: Voluntary and community sector bereavement services are central to bereavement support in the UK. AIM: To determine service providers' perspectives on access to their support before and during the COVID-19 pandemic. DESIGN: Mixed methods study using an explanatory sequential design: (1) Cross-sectional online survey of UK bereavement services; (2) Qualitative interviews with staff and volunteers at selected services. SETTINGS/PARTICIPANTS: 147 services participated in the survey; 24 interviews were conducted across 14 services. RESULTS: 67.3% of services reported there were groups with unmet needs not accessing their services before the pandemic; most frequently people from minoritised ethnic communities (49%), sexual minority groups (26.5%), deprived areas (24.5%) and men (23.8%). Compared with before the pandemic, 3.4% of services were seeing more people from minoritised ethnic groups, while 6.1% were seeing fewer. 25.2% of services did not collect ethnicity data. Qualitative findings demonstrated the disproportionate impact of the pandemic on minoritised ethnic communities, including disruption to care/mourning practices, and the need for culturally appropriate support. During the pandemic outreach activities were sometimes deprioritised; however, increased collaboration was also reported. Online provision improved access but excluded some. Positive interventions to increase equity included collecting client demographic data; improving outreach, language accessibility and staff representation; supporting other professionals to provide bereavement support; local collaboration and co-production. CONCLUSIONS: Service providers report inequities in access to bereavement support. Attention needs to be paid to identifying, assessing and meeting unmet needs for appropriate bereavement support. Identified positive interventions can inform service provision and research.

Barriers and facilitators to pharmacists' engagement in response to domestic violence: a qualitative interview study informed by the capability-opportunity-motivation-behaviour model.

BACKGROUND: Domestic and sexual violence and abuse (DSVA) is a global public health problem resulting in health inequalities. Community pharmacies are uniquely placed to help people affected by DSVA. We examined factors that impact pharmacists' engagement in response to DSVA when providing public health services. METHODS: Semi-structured qualitative interviews with community pharmacists (n = 20) were analyzed thematically, with inductive themes mapped to the Capability-Opportunity-Motivation Behaviour (COM-B) model. RESULTS: Pharmacists were confident in providing public health services, but a lack of DSVA training meant there is a need to support their 'Capability' to respond to DSVA. Pharmacies were perceived as highly accessible healthcare providers on the high street, with sexual health consultations offering an ideal 'Opportunity' to enquire about DSVA in a private consultation room. Pharmacist's 'Motivation' to enquire about DSVA was driven by potential positive client outcomes and a desire to be more involved in public heath interventions, but organisation- and system-level support and remuneration is needed. CONCLUSIONS: Community pharmacy offers opportunities for integrating DSVA work in existing public health services. Pharmacists need training on DSVA, ongoing support, allocated funding for DSVA work, and awareness raising campaign for the public on their extended public health role.

Trauma-informed co-production: Collaborating and combining expertise to improve access to primary care with women with complex needs.

INTRODUCTION: Health, social care, charitable and justice sectors are increasingly recognising the need for trauma-informed services that seek to recognise signs of trauma, provide appropriate paths to recovery and ensure that services enable people rather than retraumatise. Foundational to the development of trauma-informed services is collaboration with people with lived experience of trauma. Co-production principles may provide a useful framework for this collaboration, due to their emphasis on lived experience, and intent to address power imbalances and promote equity. This article aims to examine trauma-informed and co-production principles to consider the extent to which they overlap and explore how to tailor co-production approaches to support people who have experienced trauma. METHODS: Bridging Gaps is a collaboration between women who have experienced complex trauma, a charity that supports them, primary care clinicians and health researchers to improve access to trauma-informed primary care. Using co-production principles, we aimed to ensure that women who have experienced trauma were key decision-makers throughout the project. Through reflective notes (n = 19), observations of meetings (n = 3), interviews with people involved in the project (n = 9) and reflective group discussions on our experiences, we share learning, successes and failures. Data analysis followed a framework approach, using trauma-informed principles. RESULTS: Co-production processes can require adaptation when working with people who have experienced trauma. We emphasise the need for close partnership working, flexibility and transparency around power dynamics, paying particular attention to aspects of power that are less readily visible. Sharing experiences can retrigger trauma. People conducting co-production work need to understand trauma and how this may impact upon an individual's sense of psychological safety. Long-term funding is vital to enable projects to have enough time for the establishment of trust and delivery of tangible results. CONCLUSIONS: Co-production principles are highly suitable when developing trauma-informed services. Greater consideration needs to be given as to whether and how people share lived experiences, the need for safe spaces, honesty and humility, difficult dynamics between empowerment and safety and whether and when blurring boundaries may be helpful. Our findings have applicability to policy-making, funding and service provision to enable co-production processes to become more trauma-informed. PUBLIC CONTRIBUTION: Bridging Gaps was started by a group of women who have experienced complex trauma, including addiction, homelessness, mental health problems, sexual exploitation, domestic and sexual violence and poverty, with a general practitioner (GP) who provides healthcare to this population, alongside a support worker from the charity One25, a charity that supports some of the most marginalised women in Bristol to heal and thrive. More GPs and healthcare researchers joined the group and they have been meeting fortnightly for a period of 4 years with the aim of improving access to trauma-informed primary care. The group uses co-production principles to work together, and we aim to ensure that women who have experienced trauma are key decision-makers throughout our work together. This article is a summary of our learning, informed by discussion, observations and interviews with members of the group.

The introduction of a safety checklist in two UK hospital emergency departments: A qualitative study of implementation and staff use.

AIMS AND OBJECTIVES: To explore the extent to which a checklist designed to support patient safety in hospital Emergency Departments was recognised and used by staff. BACKGROUND: Patient crowding in UK Emergency Departments makes it difficult for staff to monitor all patients for signs of clinical deterioration. An Emergency Department Safety Checklist was developed at a UK hospital to ensure patients are regularly monitored. It was subsequently implemented in six hospitals and recommended for use across the National Health Service in England. METHODS: This was a qualitative study in two UK hospital Emergency Departments. Data collection consisted of sixty-six hours of nonparticipant observation and interviews with twenty-six staff. Observations were sampled across different days and times. Interviews sampled a range of staff. Data were analysed thematically. The study was undertaken in accordance with COREQ guidelines. RESULTS: Staff described the Emergency Department Safety Checklist as a useful prompt and reminder for monitoring patients' vital signs and other aspects of care. It was also reported as effective in communicating patient care status to other staff. However, completing the checklist was also described as a task which could be overlooked during busy periods. During implementation, the checklist was promoted to staff in ways that obscured its core function of maintaining patient safety. CONCLUSIONS: The Emergency Department Safety Checklist can support staff in maintaining patient safety. However, it was not fully recognised by staff as a core component of everyday clinical practice. RELEVANCE TO CLINICAL PRACTICE: The Emergency Department Safety Checklist is a response to an overcrowded environment. To realise the potential of the checklist, emergency departments should take the following steps during implementation: (a) focus on the core function of clinical safety, (b) fully integrate the checklist into the existing workflow and (c) employ a departmental team-based approach to implementation and training.

Patient experiences of telephone outreach to enhance uptake of NHS Health Checks in more deprived communities and minority ethnic groups: A qualitative interview study.

BACKGROUND: The NHS Health Checks preventative programme aims to reduce cardiovascular morbidity across England. To improve equity in uptake, telephone outreach was developed in Bristol, involving community workers telephoning patients amongst communities potentially at higher risk of cardiovascular disease and/or less likely to take up a written invitation, to engage them with NHS Health Checks. Where possible, caller cultural background/main language is matched with that of the patient called. The call includes an invitation to book an NHS Health Check appointment, lifestyle questions from the Health Check, and signposting to lifestyle services. OBJECTIVE: To explore the experiences of patients who received an outreach call. DESIGN/SETTING/PARTICIPANTS: Thematic analysis of semi-structured interviews with 24 patients (15 female), from seven primary care practices, who had received an outreach call. RESULTS: The call increased participants' understanding of NHS Health Checks and overcame anticipated difficulties with making an appointment. Half reported that they would not have booked if only invited by letter. The cultural identity/language skills of the caller were important in facilitating the interaction for some who might otherwise encounter language or cultural barriers. The inclusion of lifestyle questions and signposting prompted a minority to make lifestyle changes. CONCLUSIONS: Participants valued easily generalizable aspects of the intervention-a telephone invitation with ability to book during the call-and reported that it prompted acceptance of an NHS Health Check. A caller who shared their main language/cultural background was important for a minority of participants, and improved targeting of this would be beneficial.

A pilot cluster randomised controlled trial of a support and training intervention to improve the mental health of secondary school teachers and students - the WISE (Wellbeing in Secondary Education) study.

BACKGROUND: Secondary school teachers are at heightened risk of psychological distress, which can lead to poor work performance, poor quality teacher-student relationships and mental illness. A pilot cluster randomised controlled trial (RCT) - the WISE study - evaluated the feasibility of a full-scale RCT of an intervention to support school staff's own mental health, and train them in supporting student mental health. METHODS: Six schools were randomised to an intervention or control group. In the intervention schools i) 8-9 staff received Mental Health First Aid (MHFA) training and became staff peer supporters, and ii) youth MHFA training was offered to the wider staff body. Control schools continued with usual practice. We used thematic qualitative data analysis and regression modelling to ascertain the feasibility, acceptability and potential usefulness of the intervention. RESULTS: Thirteen training observations, 14 staff focus groups and 6 staff interviews were completed, and 438 staff (43.5 %) and 1,862 (56.3 %) students (years 8 and 9) completed questionnaires at baseline and one year later. MHFA training was considered relevant for schools, and trainees gained in knowledge, confidence in helping others, and awareness regarding their own mental health. Suggestions for reducing the length of the training and focusing on helping strategies were made. A peer support service was established in all intervention schools and was perceived to be helpful in supporting individuals in difficulty - for example through listening, and signposting to other services - and raising the profile of mental health at a whole school level. Barriers to use included lack of knowledge about the service, concerns about confidentiality and a preference for accessing support from pre-existing networks. CONCLUSIONS: The WISE intervention is feasible and acceptable to schools. Results support the development of a full-scale cluster RCT, if steps are taken to improve response rates and implement the suggested improvements to the intervention. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN13255300 retrospectively registered 28/09/16.

Improving access to general practice for and with people with severe and multiple disadvantage: a qualitative study.

BACKGROUND: People with severe and multiple disadvantage (SMD) who experience combinations of homelessness, substance misuse, violence, abuse, and poor mental health have high health needs and poor access to primary care. AIM: To improve access to general practice for people with SMD by facilitating collaborative service improvement meetings between healthcare staff, people with lived experience of SMD, and those who support them; participants were then interviewed about this work. DESIGN AND SETTING: The Bridging Gaps group is a collaboration between healthcare staff, researchers, women with lived experience of SMD, and a charity that supports them in a UK city. A project was co-produced by the Bridging Gaps group to improve access to general practice for people with SMD, which was further developed with three inner-city general practices. METHOD: Nine service improvement meetings were facilitated at three general practices, and six of these were formally observed. Nine practice staff and four women with lived experience of SMD were interviewed. Three women with lived experience of SMD and one staff member who supports them participated in a focus group. Data were analysed inductively and deductively using thematic analysis. RESULTS: By providing time and funding opportunities to motivated general practice staff and involving participants with lived experience of SMD, service changes were made in an effort to improve access for people with SMD. These included prioritising patients on an inclusion patient list with more flexible access, providing continuity for patients via a care coordinator and micro-team of clinicians, and developing an information-sharing document. The process and outcomes improved connections within and between general practices, support organisations, and people with SMD. CONCLUSION: The co-designed strategies described in this study could be adapted locally and evaluated in other areas. Investing in this focused way of working may improve accessibility to health care, health equity, and staff wellbeing.

Moving beyond the 'PPG': co-production and inclusion health.

BACKGROUND: We frequently fail to meaningfully incorporate patient voice in the development of health services, in particular the voices of those who are most disadvantaged. AIM: To share learning from a co-production project to improve primary care experience for those with multiple disadvantage and lived experience of trauma. METHOD: We formed a collective of women (Bridging Gaps). Group members had lived experience of poverty, mental health challenges, addictions, homelessness, and sexual exploitation. Other members were researchers, GPs, and members of a third-sector organisation. We worked alongside local GPs to change how services were delivered. We collected interviews (n = 9), ethnographic data from group meetings (n = 3), and reflective notes from group members (n = 19). Data on our process were analysed using a framework approach drawn from the principles of trauma-informed care. RESULTS: We highlight the challenges for those with multiple disadvantages and trauma experience to meaningfully and safely engage in traditional Patient Participation Group (PPG) models. True co-production of services requires adequate resources and close collaborative working with local community organisations. Groups must be facilitated by those with relevant experience and the ability to both notice and manage power dynamics within the room. With sufficient support, co-production models have potential to empower group participants and improve health services. CONCLUSION: Partnership working between GPs, the third sector, and other organisations is vital. This can allow GPs to benefit from the expertise of those with relevant lived experience in tackling health inequalities.

Scaling up an intervention to protect preterm infants from neurodevelopmental disabilities - findings from a qualitative process evaluation comparing standard with enhanced quality improvement support packages for maternity units in England.

BACKGROUND: A quality improvement strategy (PReCePT) was used in a standard and enhanced format to scale up a clinical intervention (administering magnesium sulphate to women in preterm labour) across all maternity units in England to protect prematurely born infants from neurodevelopmental disabilities. Formal evaluations reported the effectiveness of the standard package alone in increasing the administration of magnesium sulphate. In this paper, we focus on the findings of the process evaluations, using normalisation process theory to explain how different implementation contexts generated the observed outcomes relating to normative and relational restructuring and sustainment. METHODS: Interviews were conducted with key individuals in implementation of leadership positions nationally and locally. Interviews were analysed initially using the framework method. We then engaged recursively with NPT constructs to generate generalisable insights with pragmatic applicability in other settings. RESULTS: In total, 72 interviews were conducted with good representation from units across England and staff from the National Academic Health Science Network. We found that all units irrespective of whether they received a standard or enhanced QI package were successful in the 'normative restructuring' of their setting to enable magnesium sulphate to be administered. This suggests that this implementation outcome is necessary to achieve improvements. However, it may not be sufficient to sustain the changes once additional resources have been withdrawn. Sustainment, our findings suggest, required 'relational restructuring' to accommodate altered workflows and facilitate the sharing of responsibilities and tasks in daily practice. Relational restructuring was more likely to have been achieved units receiving enhanced QI support but also happened in units with standard QI support, especially in those where perinatal team working was already well established. CONCLUSION: Unlike other large QI-focused spread-and-scale programmes which failed to show any impact on outcomes, the PReCePT programme in both the enhanced and standard support packages led to improvements in the uptake of magnesium sulphate. The findings suggest that QI programmes interact with the enabling factors, such as strong interprofessional team working, already present in the setting. A standard package with minimal support was therefore sufficient in settings with enabling factors, but enhanced support was required in units where these were absent.

Integrating care between an NHS hospital, a community provider and the role of commissioning: the experience of developing an integrated respiratory service.

OBJECTIVES: An integrated respiratory service was commissioned in 2016 in a UK region to support patients with chronic obstructive pulmonary disease. The service brought together the respiratory department of a National Health Service hospital and a not-for-profit community provider. This paper evaluates: (1) the perceived efficacy of integrated working between the organisations from the perspective of staff and (2) the relationship between commissioning and integration of the services. DESIGN: Semistructured interviews with staff from the three organisations involved in the integrated respiratory service. Staff were purposefully sampled. The interviews were audio recorded, transcribed and analysed thematically. SETTING: Secondary care respiratory unit; community provider of respiratory care; and a clinical commissioning group. PARTICIPANTS: Nineteen interview participants: nine from the community provider; eight from the hospital and two from the clinical commissioning group. RESULTS: Staff identified lack of integration between the organisations characterised by: poor communication, lack of trust, absence of shared information technology and ineffective integrative initiatives. The commissioning process created barriers to integration including: contractual limitations which prevented pathway development, absence of agreed clinical governance arrangements and lack of recognition of community work undertaken by hospital staff. Positive working relationships were established over time as staff recognised the skills that each had to offer. CONCLUSIONS: The commissioning process underpinned the relationship between the organisations and contributed to distrust and negative perceptions of the 'other'. Commissioning an integrated service should incorporate dialogue with stakeholders as early as possible and before the contract is finalised to develop a bedrock of trust.

What are the risks and benefits of temporarily discontinuing medications to prevent acute kidney injury? A systematic review and meta-analysis.

OBJECTIVES: To summarise evidence on temporary discontinuation of medications to prevent acute kidney injury (AKI). DESIGN: Systematic review and meta-analysis of randomised and non-randomised studies. PARTICIPANTS: Adults taking diuretics, ACE inhibitors (ACEI), angiotensin receptor blockers (ARB), direct renin inhibitors, non-steroidal anti-inflammatories, metformin or sulfonylureas, experiencing intercurrent illnesses, radiological or surgical procedures. INTERVENTIONS: Temporary discontinuation of any of the medications of interest. PRIMARY AND SECONDARY OUTCOME MEASURES: Risk of AKI. Secondary outcome measures were estimated glomerular filtration rate and creatinine post-AKI, urea, systolic and diastolic blood pressure, death, clinical outcomes and biomarkers. RESULTS: 6 studies were included (1663 participants), 3 randomised controlled trials (RCTs) and 3 prospective cohort studies. The mean age ranged from 65 to 73 years, and the proportion of women ranged from 31% to 52%. All studies were in hospital settings; 5 evaluated discontinuation of medication prior to coronary angiography and 1 prior to cardiac surgery. 5 studies evaluated discontinuation of ACEI and ARBs and 1 small cohort study looked at discontinuation of non-steroidal anti-inflammatory drugs. No studies evaluated discontinuation of medication in the community following an acute intercurrent illness. There was an increased risk of AKI of around 15% in those in whom medication was continued compared with those in whom it was discontinued (relative risk (RR) 1.17, 95% CI 0.99 to 1.38; 5 studies). When only results from RCTs were pooled, the increase in risk was almost 50% (RR 1.48, 95% CI 0.84 to 2.60; 3 RCTs), but the CI was wider. There was no difference between groups for any secondary outcomes. CONCLUSIONS: There is low-quality evidence that withdrawal of ACEI/ARBs prior to coronary angiography and cardiac surgery may reduce the incidence of AKI. There is no evidence of the impact of drug cessation interventions on AKI incidence during intercurrent illness in primary or secondary care. TRIAL REGISTRATION NUMBER: PROSPERO CRD42015023210.

The risks and benefits of patients temporarily discontinuing medications in the event of an intercurrent illness: a systematic review protocol.

BACKGROUND: Acute kidney injury (AKI) is common and often leads to significant morbidity and/or death. The development of AKI, or complications associated with it, may be due to use of certain medications in at-risk patients experiencing an intercurrent illness. Implicated drugs include diuretics, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/direct renin inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs), metformin and sulfonylureas. Expert consensus opinion (and clinical guidelines) recommend considering discontinuation of diuretics, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/direct renin inhibitors, NSAIDs, metformin and sulfonylureas in the event of an intercurrent illness to prevent AKI onset or reduce severity or complications. However, the evidence base for these recommendations is very limited. This systematic review aims to address the available evidence for the temporary discontinuation of diuretics, ACE inhibitors, angiotensin receptor blockers, direct renin inhibitors, non-steroidal anti-inflammatories and metformin and sulfonylureas for those at risk of AKI or with newly diagnosed AKI. METHODS/DESIGN: Randomised controlled trials; non-randomised trials; cohort studies; case-control studies; interrupted time series studies; and before-and-after studies featuring adults aged 18 and over in any setting currently taking diuretics, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/direct renin inhibitors, NSAIDs and metformin; experiencing an intercurrent illness; or undergoing a radiological/surgical procedure (planned or unplanned) will be searched for. Relevant trial registers and systematic review databases will be searched. Systematic reviews will be assessed for methodological quality using the ROBIS tool, trials will be assessed using the Cochrane risk of bias tool, and observational studies will be assessed using the ACROBAT-NRS tool. If sufficient studies assessing similar populations, study type, settings and outcomes are found, then a formal meta-analysis will be performed to estimate summary measures of effect. If not, a narrative synthesis will be adopted. DISCUSSION: This review will synthesise evidence for the efficacy of discontinuing diuretics, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/direct renin inhibitors, NSAIDs, metformin or sulfonylureas to prevent or delay onset of AKI or associated complications. Results will provide guidance on efficacy and safety of this strategy and potentially help to develop an intervention to test the best mechanism of guiding medication discontinuation in at-risk populations. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015023210.

Differences between research ethics committees.

OBJECTIVES: To examine differences in the ethical judgments made by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs). METHODS: We did a review of the literature and included any study that attempted to compare the ethical judgments made by different RECs or IRBs when reviewing one or more protocol. RESULTS: There were twenty-six articles reporting such discrepancies across Europe, within the United Kingdom, Spain, and United States. Of these studies, there were only five reports of some RECs approving while others rejecting the same protocol. All studies, however, reported differences in the clarifications and revisions asked of researchers regarding consent, recruitment, risks and benefits, compensation arrangements, and scientific issues. CONCLUSIONS: The studies were generally anecdotal reports of researchers trying to do research. New rules requiring a single ethical opinion for multi-site research at least in European Member States may simply conceal problematic issues in REC decision making. In the last analysis, we should expect a certain degree of variation and differences if we are to keep a committee system of review, although there is a pressing need to investigate the way in which RECs make these judgments. In particular, we need to identify the source of any aberrations, distortions, or confusions that could arbitrarily affect these judgments. Furthermore, local conditions remain important ethical considerations and should not be sidelined in pursuit of greater "consistency."