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Survival of the fittestOur not-too-distant past is zithromax amoxicillin decorated zithromax 500mg for sale with artefacts. Strategies that became popular for perfectly tenable reasons, had a Warholian 15 min of (perfectly justified) fame and then, as new perspectives developed were consigned to the museums of (spectacles rose- tinted) folklore or (spectacles replaced by blinkers) closed chapters ‘we’d rather not discuss’. There is also, though, another, third, zithromax 500mg for sale group. Those practices that have evolved and improved as a result of a recognition of limitations and evolution. In geological terms at least, it zithromax 500mg for sale wasn’t that long (mid 1980s) since I was a medical student when the roll call of popular interventions included the mist tent in croup.

This involved creating a fog in which 1 year-old children became not only detached from their parents but distressed by their treatment in a polythene tent draped over their cot (figure 1).The mist tent for croup. Gomez. Archives 1968." data-icon-position data-hide-link-title="0">Figure 1 The mist zithromax 500mg for sale tent for croup. Gomez. Archives 1968.Other practices in use at that time or shortly after included the use of the lateral neck X-ray in children with suspected epiglottitis, lumbar puncture in all children with a first febrile seizure under the age of 18 months (even if they were happily running around the ward and near impossible to catch) and routine intubation and saline lavage for all neonates with zithromax 500mg for sale meconium staining to ‘cover the risk of aspiration’ – great for practice, likely of very limited benefit in terms of outcomes.We do our best, live, learn and adaptThis month’s examples are from group 3.

Excellent in principle, have evolved, and, as a result, are here to stay in one form or anotherPaediatric emergency medicineThe rise, ‘saturation’ by and rethink of early warning scoresAfter a honeymoon period noticeable for its uncritical reception and (in many cases) lack of objective assessment, paediatric early warning scores (PEWS) proliferated exponentially to the point of submersion over a short period. There was a (although well-intentioned) degree of naivete in this unbounded parameter-driven enthusiasm. The proliferation, of course, for zithromax 500mg for sale all the excellent intentions, was part of the problem. There were simply too many in use and it was impossible to familiarise with more than a small proportion of them all. That, of zithromax 500mg for sale course, was part of the problem.

We know now that human factors (inconsistency and interobserver variability) and insensitivities in the tools themselves (decompensation is often more subtle than measurable physiological deterioration) contribute to their imperfections. The largest of the red flags came in zithromax 500mg for sale the form of the outstanding EPOCH study, a cluster multi-European centre RCT including 140 000 children in which the bedside PEWS was shown to have no effect on reducing mortality in the intervention limb children. There was though, a difference in time to detection of deterioration and the focus has moved to this area in tool development. We should, therefore applaud, the initiative by the RCPCH, NHS England and NHS improvement described by Damian Roland and Simon Kenny to standardise the system, derive and use only a single score. The advantages are zithromax 500mg for sale obvious.

Consistency. Simplification of communicating trends between observers and hospitals to transcription errors possible when several scores are in zithromax 500mg for sale circulation. There may not be an immediate reduction in mortality, but the advantages in everyone speaking the same language are clear. See page 648Fetal alcohol syndromeHere’s a paradox. For an issue as pervasive as fetal alcohol exposure and a phenotype as common as FAS, we zithromax 500mg for sale know very little indeed about the epidemiology.

First recognised in the early 1970s when the classic (phium, upturned nose, epicanthus, palpebral fissure combination) phenotype was described. Prevalence estimates are complicated by the small number (likely less than 10%) of children showing zithromax 500mg for sale these signs, the rest of the iceberg manifesting much less specific neurobehavioural signs. Add to this the sensitivities around exposure information, making a social services decision based on uncertain data, issues around screening antenatally (there are biomarkers available) and the low yield in genetic work up series and the ways forward, other than primary prevention, become muddied. Read both Raja Mukerjhee’s review and zithromax 500mg for sale Zena Lam’s series and make your own minds up whether FAS should fall into the (until recently) neglected disease bracket. See pages 653 and 636Fever hospitalsWe all know about the cyclical nature of history, but the timing of Philip Mortimer’s ‘Voices’ paper about the London fever hospitals is uncannily good with respect to recent events and policy indecisiveness.

The underpinning philosophy behind the hospitals was admirable. In Victorian England, beyond a degree zithromax 500mg for sale of responsibility from poor law unions, there was effectively no central accountability for provision of care for febrile children from families of limited means. This era was the heyday of, among others, typhoid, scarlet fever, diphtheria and smallpox. With no viable alternatives, in zithromax 500mg for sale 1867, Parliament took hold of the issue by the great philanthropophic leap of creating the ‘Medical Asylum Board’ whose main remit became the establishment of specific fever centres. After several decades in well-deserved limelight, the hospitals fell out of favour as much with parents as policy makers, the result of a combination of a change in infectious disease epidemiology, the recognition of the psychological harm to children that the prolonged spells in isolation could have and a creeping malaise around the risk of intra-hospital exposure.

Darwin, aboard the Beagle, would no doubt have smiled wryly… See page 724Ethics statementsPatient consent for publicationNot required.Charging those with uncertain immigration status for NHS services was introduced as part of Theresa May’s ‘hostile environment’. Non-payment of bills can result in being reported to the Home Office and used as a reason for not being granted settled zithromax 500mg for sale status. This system remains in place during the buy antibiotics zithromax, actively discouraging healthcare seeking through the threat of immigration enforcement. Of around 618 000 people living in the UK but without the documentation to prove a regular immigration status, it is estimated that 144 000 are children,1 half zithromax 500mg for sale having been born here. The legislation over charging introduced by the government under the spurious pretext of targeting ‘health tourism’ represented an unprecedented departure from the founding principles of the NHS and, among other adverse effects, has a negative impact on child health.2On a global scale, the numbers of people forcibly displaced from their homes because of conflict, persecution, natural disasters and famine reached 68.5 million by the end for 2017 and continues to rise.

Children make up zithromax 500mg for sale over half the world’s refugees and, like other asylum seekers and undocumented migrants, they are exposed to multiple risk factors for poor physical and mental health throughout their migration experience.3 NHS charging regulations undermine the government’s stated commitments to child health, as well as obligations to children under the United Nations Convention on the Rights of the Child (Article 24). This states that governments recognise the right of the child to the enjoyment of the highest attainable standard of health and to facilities for the treatment of illness and rehabilitation of health and, furthermore, that they will strive to ensure that no child is deprived of his or her right of access to such healthcare services. Charging also contradicts recommendations outlined in the UN Global Compact for Migration, signed by the UK in 2018.2A briefing paper from Medact (https://www.medact.org) written to support those campaigning against the hostile environment in the NHS argues that the health system functions as a foundation for societal well-being and a platform for the expression of ethical behaviour. The NHS was founded on the principle of treating everyone zithromax 500mg for sale in the country regardless of status, wealth or origin. The idea that people can be either eligible or ineligible to access care contradicts the central reasoning behind collective provision in which pooling finances through general taxation shares risk and ensures equity in healthcare for all.4 This is brought into sharp focus by the current challenge set by antibiotics.

While it has been argued that services for treatment of infectious diseases, including the tests required to diagnose them, are in fact exempt zithromax 500mg for sale from charges, people do not present with a ‘diagnosis’ but with symptoms. This means that for many, fear of incurring charges is preventing them from seeking care for themselves or their children.5 As we move once again towards much needed contact tracing as a crucial element in disease containment (test, trace, isolate, support and integrate), it has been pointed out that for this to be viable, all sections of the community must be willing to be contacted by the NHS or public health staff. Unlike the UK, the Irish government has declared that all people—documented or undocumented—can now access healthcare and social services without fear.6 Undocumented migrants and asylum seekers in Portugal have been granted the same rights as residents, including access to medical care, and in South Korea, they can be tested without risk of deportation.6 Sadly, the UK stubbornly resists change to a policy that is both discriminatory and dangerous at a public health level.Long before the buy antibiotics zithromax, the Faculty of Public Health (FPH) had raised concerns about the potential for underdiagnosis and undertreatment of infectious diseases arising from the charging policy.7 Medact called on care providers to undertake detailed research into the impact of both charging and identity checks on patients’ health and on a hospital’s ability to meet its equality duty, and other legal obligations, including professional duties of care that staff have towards their patients. It also called on zithromax 500mg for sale the Department of Health and Social Care (DHSC) to commission a full independent inquiry into the impact of the regulations, and to publish their own internal review of the 2017 charging. Unfortunately, these demands have not been met.Members of Medact, in conjunction with paediatrician colleagues, have themselves recently published a revealing investigation into attitudes towards and understanding of UK healthcare charging among members of the Royal College of Paediatrics and Child Health (RCPCH).8 From 200 responses by healthcare staff, it was evident that there was a lack of understanding of current NHS charging regulations and their intended application, with 94% saying they were not confident about which health conditions are exempt from charging regulations and one-third reporting examples of how the charging regulations have negatively impacted on patient care.

The survey identified 18 cases of migrants being deterred zithromax 500mg for sale from accessing healthcare, 11 cases of healthcare being delayed or denied outright, and 12 cases of delay in accessing care leading to worse health outcomes, including two intrauterine deaths. The authors of the study concluded that NHS charging regulations are having direct and indirect impacts on migrant children and pregnant women, with evidence of a broad range of harms. Additionally, they are unworkable and are having a detrimental impact on the wider health system, as well as conflicting with the professional and ethical responsibilities of staff.8In 2018, the RCPCH joined with the Royal College of Physicians, the Royal College of Obstetricians and Gynaecologists and the FPH to call on the DHSC to suspend charging regulations pending a full independent review of their impact on individual and public health.9 The RCPCH has reiterated its opposition to charging.10 On a broader front, the Institute of Race Relations has publicised how the appallingly overcrowded and unhygienic housing offered to some asylum seekers and their young children is putting them at increased risk of buy antibiotics .11 Sixty cross-party MPs have now written to the health secretary, Matt Hancock, calling for the suspension of charging for migrants and all associated data-sharing and immigration checks, which they say are undermining the government’s efforts to respond to the zithromax.12 We should all reiterate this call and insist that these demands are implemented with immediate effect..

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PhAST, Cambridge, MA Discover More 8 does zithromax have sulfa in it. University of South Florida College of Public Health &. Morsani College of Medicine, Tampa, FL, USA 9. National Reference Laboratory Division, Department of Biomedical Services, Rwanda Biomedical Center, Kigali, Rwanda, Department of Clinical Biology, School of Medicine and Pharmacy, College of Medicine and Health Sciences, University ofRwanda, Kigali, Rwanda 10.

Department of does zithromax have sulfa in it Genetics, University of Cambridge, Cambridge, UKPublication date:01 November click resources 2021More about this publication?. The International Journal of Tuberculosis and Lung Disease (IJTLD) is for clinical research and epidemiological studies on lung health, including articles on TB, TB-HIV and respiratory diseases such as buy antibiotics, asthma, COPD, child lung health and the hazards of tobacco and air pollution. Individuals and institutes can subscribe to the IJTLD online or in print – simply email us at [email protected] for details. The IJTLD is dedicated to understanding lung disease and to the dissemination of knowledge leading to better lung health.

Morsani College http://coolcycledude.com/electronic-transmissions-on-motorcycles-why/ of Medicine, zithromax 500mg for sale Tampa, FL, USA 9. National Reference Laboratory Division, Department of Biomedical Services, Rwanda Biomedical Center, Kigali, Rwanda, Department of Clinical Biology, School of Medicine and Pharmacy, College of Medicine and Health Sciences, University ofRwanda, Kigali, Rwanda 10. Department of Genetics, University of Cambridge, Cambridge, UKPublication date:01 November 2021More about this publication?. The International Journal of Tuberculosis and Lung Disease (IJTLD) is for clinical research and epidemiological studies on lung health, including articles on TB, TB-HIV and respiratory diseases such as buy antibiotics, asthma, COPD, child lung health and the hazards of tobacco and air pollution. Individuals and institutes can subscribe to the IJTLD online or in print – zithromax 500mg for sale simply email us at [email protected] for details check out here.

The IJTLD is dedicated to understanding lung disease and to the dissemination of knowledge leading to better lung health. To allow us to share scientific research as rapidly as possible, the IJTLD is fast-tracking the publication of certain articles as preprints prior to their publication. Read fast-track articles.Editorial BoardInformation for AuthorsSubscribe to this TitleInternational Journal of Tuberculosis and Lung DiseasePublic Health ActionIngenta Connect is not responsible for the content or availability of external websites.

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Patients are more likely to experience preventable harm during perioperative care than in any other type of healthcare encounter.1 2 For several decades, a hallmark of surgical quality and safety has been the use of checklists to prevent errors (eg, wrong site surgery) and assure that key tasks have been or is zithromax and amoxicillin the same will be performed. The most widely used approach globally is the Surgical Safety Checklist (SSC) recommended by the WHO.3 It is divided into preinduction (or sign in, consisting of seven items performed by anaesthesia and nursing), preincision (timeout, 10 items performed by the entire team) and postsurgery (sign out, five items by the entire team).4 5 Most hospitals in the developed world perform the SSC or an equivalent timeout prior to is zithromax and amoxicillin the same surgical incision. However, preinduction briefings, and postcase debriefings in particular, are much less commonly performed.6 7There are widely disseminated arguments recommending the use of checklists in healthcare8 but also recognised limitations.9 Checklist-based preincision timeouts appear to improve surgical outcomes in many settings,4 5 yet, in other hospitals, the introduction of the SSC failed to improve outcomes.10 Like all tools or processes intended to improve safety, ineffective implementation will reduce the desired benefits. For example, there is appreciable evidence showing that surgical teams skip or do not meaningfully respond to timeout checklist items.11 12 Even with a robust implementation, effectiveness can be weakened by contextual factors, failure of leadership or deficient is zithromax and amoxicillin the same safety culture.Despite numerous studies, gaps in the evidence to guide optimal checklist use persist.

For example, we do not know whether checklist-based timeouts only decrease the occurrence of the undesirable events targeted by the checklist or, as many hypothesise, whether their use also facilitates teamwork and interprofessional communication. Although there is increasing guidance on how to optimally implement checklists at the local level, many is zithromax and amoxicillin the same questions remain.13 Moreover, we still do not understand the circumstances in which checklist use facilitates the detection, reporting and correction of errors.In this issue of the journal, Muensterer and colleagues14 describe a clever study in which the attending surgeon intentionally introduced errors during the preincision timeout while a medical student in the operating theatre surreptitiously noted whether the error was detected and reported by one or more members of the surgical team. If the error was not verbalised, the attending surgeon corrected the error before the timeout was complete. The single error embedded in each of 120 of 1800 paediatric operations was randomly chosen from among wrong is zithromax and amoxicillin the same patient name, age, gender, allergy or surgical procedure, side or site.

Overall, only about half (65. 54%) of all errors were detected and reported by a team member prior is zithromax and amoxicillin the same to surgeon correction. Of these, errors were most commonly reported by the anaesthesiologist (64%) and almost never by residents in training (6%) or medical students (1%).This study also has important limitations. Because the investigators were leading the timeouts as part of a research study, adherence to all of the checklist items was is zithromax and amoxicillin the same reportedly 100%.

Yet, few organisations consistently attain timeout adherence above 90%.11 Since you are less likely to catch an error if you do not address that item during the timeout, in institutions with lower adherence, the proportion of missed errors may be even higher.The authors, with input from their institutional review board, designed the study to be feasible and compliant with established human subjects protection principles. As such, the attending surgeon always corrected the error after is zithromax and amoxicillin the same the anaesthesiologist’s component of the timeout but before the nurses’ component. By excluding the part of the timeout when the nurses address their checklist items (eg, instruments are sterile,) followed by a final opportunity as the timeout ends to note any errors or concerns, the study may have underestimated the rate of error reporting.Because the study did not query team members individually after the timeout, we also do not know how many errors were detected but not annunciated. For example, recognised errors that were attributed to ‘misspeaking’ and/or had no clinical is zithromax and amoxicillin the same significance may not have been verbally challenged.

Moreover, as is discussed by the authors, there was an unequivocal hierarchy effect—individuals with the least ‘power’ (ie, low in hierarchy within the current healthcare culture) were the least likely to report the error.This study highlights two important safety relevant questions on which I will elaborate. First, why and how should we change healthcare culture to facilitate ‘speaking up’? is zithromax and amoxicillin the same. Second, how can we best design and implement checklists and other safety interventions to yield more consistent and sustained clinician behaviour change?. The continued problem is zithromax and amoxicillin the same of hierarchical culture in healthcareThe significant influence of hierarchy on the incidence of error reporting in Muensterer et al’s14 study is consistent with substantial prior evidence that lower hierarchy clinical providers are less likely to ‘speak up’, even when they are aware of major safety violations.15–17Failure of a subordinate copilot to challenge or speak up to the captain in the 1977 Tenerife disaster was the impetus for the aviation industry’s adoption of crew resource management (CRM).

Healthcare team-training initiatives like the Agency for Healthcare Research and Quality’s TeamSTEPPS now include tools such as the ‘two-challenge rule’ and emphasise speaking up.18 Flattened hierarchies and reliance on expertise rather than seniority, especially during crisis or stress, are an integral component of high-reliability organisations. In contrast, the persistent hierarchical culture of healthcare is anathema is zithromax and amoxicillin the same to positive safety attitudes and behaviours. This is particularly problematic in operating theatres where surgeons view themselves as ‘captain of the ship’ and where uncivil behaviour is tolerated.19 The insidious effects of hierarchy will impair effectiveness of checklist use and predispose to safety issues in all aspects of routine and emergency care.20 While team-oriented training designed to enhance the ability of lower hierarchy clinicians to ‘speak up’ can be effective,21 22 evidence to guide the design and implementation of these interventions is still sparse. Single training exposures have generally had limited effects,17 23 in part likely due to inadequate ‘potency’ to achieve the desired effect24 in a clinical environment contaminated by the hierarchical culture and in part because most interventions have focused on ‘assertiveness’ training for the less powerful members of is zithromax and amoxicillin the same the team rather than, or in addition to, sensitivity or receptivity training of the most powerful (eg, surgical attendings).17Discussions of power hierarchy to date have largely focused on clinicians’ professional roles (ie, nurse vs physician) and level of experience (eg, resident vs attending).

Even with two attending physicians, for example, a surgeon and anaesthesiologist, power dynamics can degrade communication and decrease team performance. In a multicentre study of experienced anaesthesiologists managing simulated crisis events, the anaesthesiologists’ failure to challenge the surgeon to initiate life-saving interventions (eg, to open the abdomen in the presence of an enlarging retroperitoneal haematoma during laparoscopic surgery, or to halt surgery to cardiovert an unstable patient) was associated with lower overall scenario performance scores as determined by trained blinded anaesthesiologist video raters.25In fact, hierarchy is much more complex and this may explain in part the variable is zithromax and amoxicillin the same and generally weak results seen in ‘speaking up’ intervention studies to date. When considering hierarchical effects on communication assertiveness, one must also consider individual characteristics including gender, race/ethnicity, language, personal cultural background and personality, as well as the personality of those in higher power roles, microclimate factors of the team and care unit, and overall organisational culture.17 22 An interesting direction for future study is the facilitation of more positive communication (eg, expressions of gratitude or encouragement).26In a single-site intervention study to improve the quality of handovers from anaesthesia professionals to postanaesthesia care unit (PACU) nurses,27 simulation-based training emphasised specific dyadic communication behaviours—assertiveness for the nurses when their needs were not being met and ‘sensitivity’ (or receptiveness) for the anaesthesia professionals when the nurses raised concerns. In poststudy interviews, this behavioural focus was considered an important contributor to the resulting sustained improvement in the quality of actual is zithromax and amoxicillin the same handovers.

As part of this study, we explicitly taught participants to CUSS. CUSS is a graduated approach to is zithromax and amoxicillin the same facilitate speaking up. The acronym stands for ‘I’m Concerned’, ‘I’m Uncomfortable’, ‘This is a Safety issue’ and ‘Stop!. €™.

The intended learners were taught these ‘triggers’ for eliciting desired behaviours (ie, to stop what they are doing and have a conversation with the initiator) and this approach creates an environment where the initiating individual can receive support from others who overhear the conversation—‘Doctor, I hear that Maria is CUSSing at you?. How can I help to resolve this situation?. €™ Such a graded assertiveness approach to ‘stop the line’, developed in other industries, is increasingly being used throughout healthcare.28Designing and implementing more effective safety tools and processesSSCs are just one tool used to advance overall perioperative system safety. Similarly, in commercial aviation, checklists are one tool used as part of CRM to assure operational safety.

CRM is a philosophy or construct that includes explicit values and principles, procedures supported by purpose-designed checklists and other tools, and regularly scheduled mandatory simulation-based training and assessment that together contribute to an existing safety culture in pilots and across the organisation.29 CRM and most of the existing aviation safety system were iteratively designed by pilots (the front-line workers) in collaboration with other stakeholders (including regulators). Healthcare must employ similar human-centred design approaches to re-engineer our safety systems.For commercial aviation to be completely safe, no planes would fly. Similarly, safety will never be the foremost system objective in healthcare. The primary goal is to efficiently deliver cost-effective care.

Instead, in any high-consequence industry, safety is a desirable by-product (an ‘emergent feature’) of a system designed to achieve primary operational goals. In healthcare, sick patients must be treated and there is inherent risk in doing so.30 Achieving societally acceptable levels of safety will stem from a deliberately designed system founded on a strong safety culture and truly committed leadership.With this as background, it is not surprising that so many hospitals struggle to garner reliable and sustained benefit from the use of checklists and other safety tools. To understand what is required, I would like to draw parallels with anaesthesiology’s experience of implementing another type of checklist.The Food and Drug Administration Anesthesia Machine Pre-Use ChecklistThe earliest checklist used in healthcare to reduce adverse events is the anaesthesia equipment preuse checklist, developed in 1987 by the US Food and Drug Administration (FDA) in collaboration with the Anesthesia Patient Safety Foundation and the American Society of Anesthesiologists.31 After more than three decades of use, lessons learnt from the use of the FDA checklist parallel more recent experiences with SSCs, and are instructive to a more general understanding of the role of safety tools in healthcare (see table 1).View this table:Table 1 Lessons learnt from 30 years of personal experience with and reflection about the Anesthesia Equipment Pre-Use Checklist*A checklist alone is insufficient to achieve optimal resultsHospitals that get the best results from an SSC implementation are often well-resourced organisations that already have safety-oriented committed leadership, a strong safety culture, educated and engaged front-line clinicians and an established track record of successfully implementing other safety interventions.32 That said, any hospital, given adequate commitment, resources and expertise, can implement an SSC or other substantive safety intervention successfully. In doing so, it will educate and engage its workers, improve its safety culture and set the stage for further safety and quality improvements.A multimodal approach to safety interventions is more effective.

Hospitals that were able to successfully implement all three components of the SSC saw greater reductions in postoperative complications.33 Similarly, the combination of the SSC with a complementary approach that more fully addresses preoperative and postoperative issues, the Surgical Patient Safety System, was associated with better postoperative outcomes than use of the WHO SSC alone.34 The most effective interventions are those that are based on an integrated conceptual framework and follow human factor principles, especially when the safety goals are multiple or diverse.35In our PACU handover improvement project mentioned earlier,27 the multimodal intervention produced a fourfold improvement in observed clinician behaviours (ie, conduct of actual handovers) that was sustained for at least 3 years after the intervention ceased. The project began by getting perioperative leadership buy-in, conducting observations of the current handover process and engaging front-line clinicians in all phases of study development. The criteria for an ‘acceptable handover’ were chosen by an independent team of clinicians. Front-line clinicians first completed a multimedia introductory webinar that included key principles and a knowledge assessment.

To attend the 2-hour simulation training session, both anaesthesia professionals and PACU nurses were relieved from regular clinical duties (a strong message that this was an organisational priority). A custom patient-specific electronic form was available at every bedside in the PACU to reinforce the training during actual handovers. Performance feedback was provided to individuals, units and perioperative leadership. The number of components needed for successful safety interventions will depend on the behaviour change desired, the existing safety culture, current experience and expertise of the intended end users and the priority articulated by organisational leaders.

Regardless, design and implementation must be based on a solid conceptual framework, consider the full life-cycle of the intervention (from conceptualisation to obsolescence) and employ human factors engineering and implementation science principles and tools.13ConclusionChecklists and other safety tools are potentially valuable tools to advance perioperative safety. However, when used in isolation or implemented incorrectly, checklists have significant limitations. Safety initiatives that take a systems-oriented multimodal approach to design and implementation can, with organisational leadership and determination, produce both targeted and more general safety improvement.Ethics statementsPatient consent for publicationNot required.Many patients admitted to hospital require venous access to infuse medications and fluids. The most commonly used device, the peripheral venous catheter, ranges from 2.5 to 4.5 cm in length, and is typically used for less than 5 days.

The midline, a relatively newer peripheral venous catheter, is up to 20 cm in length, but does not reach the central veins, and may be used for up to 2 weeks. A peripherally inserted central venous catheter (PICC) is a longer catheter that is placed in one of the arm veins and extends to reach the central veins. The PICC is used for longer periods of time compared with peripheral intravenous devices, and initially gained popularity as a convenient vascular access device used in the outpatient and home settings. Its premise has been to provide access that lasts for weeks, that is fairly safe and easily manageable.

Patients often require central venous access when hospitalised, with more than half of patients in intensive care, and up to 20% in those cared for in the non-intensive care wards.1 Common indications for PICC use in the acute care setting include the requirement for multiple and frequent infusions (eg, antibiotics, parenteral nutrition), the administration of medications incompatible with peripheral infusion, invasive haemodynamic monitoring in critically ill patients, very poor venous access and frequent need for blood draws.2 Specially trained healthcare workers place PICCs, often nurses from a vascular access team (VAT), or interventional radiologists. The VAT is comprised of skilled nurses, with either medical/surgical, emergency department or intensive care unit backgrounds. Contrary to other healthcare workers that place PICCs, the VAT’s primary function is to place PICCs, and optimise the infusion delivery, through a safe and effective process. Its scope includes assessment for need, peripheral and central device insertion, monitoring of use and removal.3In their study of five hospitals within the Veterans Administration (VA) healthcare systems in the USA, Krein et al4 underscore the importance of a formal VAT to formulate and implement explicit appropriateness criteria, ensure timely insertion and safe management and direct patient education around PICC use.

They found that team structures supporting line placement vary across hospitals from a dedicated team, to individual nurses trained in placement, to hospitals where only interventional radiologists insert PICCs. The presence of a VAT was associated with more defined criteria for PICC use, but a recurrent theme was inadequate interdisciplinary dialogue. Although qualitative data were gathered at five VA hospitals only, the study’s findings reflect the variation in PICC placement and use, whether in academic or community, small or large hospitals.An important factor in variation in the approach to PICC line placement and management is the availability of resources and expertise at the hospital site. For example, if healthcare workers have suboptimal skills to place peripheral venous catheters, including midlines,5 clinicians may resort to ordering more PICCs unnecessarily to fill that void.

Furthermore, as revealed in Krein’s study, a hospital that does not have the expertise to learn about alternative devices, such as those with lower risks and shorter dwell times (eg, midlines), may resort to using more PICCs than necessary. Similarly, hospitals without clinicians skilled or comfortable placing other central lines6 may rely more on using PICCs. In addition, the lack of an available VAT to place PICCs using uasound guidance may result in more referrals to interventional radiology for placement, potentially exposing the patient to avoidable radiation during fluoroscopy.7We propose an approach to improve the appropriate and safe use of PICCs by focusing on three elements that address the findings by Krein and colleagues. Establishing a structure powered by a VAT.

Anchoring a standardised process for line selection, insertion and care. And promoting adoption by engagement with the key stakeholders.Establishing a structure to support placement and management of PICCs depends on whether the number of devices placed is enough to support the creation of a dedicated vascular access programme. Leadership plays a critical role to invest the resources for a functional VAT, understanding the financial and quality benefits associated.8 Not realising its value, hospital leaders may view the VAT as a non-revenue-generating service, putting it at risk when considering cost reduction strategies. The value of the VAT expands from mitigating preventable events (eg, deep venous thrombosis, ) to enhancing patient experience (eg, less attempts to place a peripheral device).9 In addition, better outcomes help curb the financial risks (eg, hospital-acquired condition penalties)8 and improve hospital ratings.

The VAT’s role encompasses placing PICCs and guaranteeing the proper selection of the intravascular device and its appropriate use.2The second element involves standardising processes for line selection and care, regardless of who is taking care of the device. Implementing policies to address indications, placement and maintenance and using standardised kits help minimise variation. The creation of policies should be achieved through a multidisciplinary approach with VAT, nurses and physicians. The VAT can act as the ‘gate keeper’ evaluating whether the reason for PICC placement is aligned with indications.

In addition, the VAT plays a critical role supporting nurses’ competencies for venous catheter use (eg, aseptic access and maintenance, addressing complications and mitigating risk)10 to reduce mechanical11 and infectious complications.12 The VAT performs regular rounds to mitigate process gaps (eg, dressing site intactness) and to identify complications (eg, PICC site erythema or drainage, arm swelling), and provides timely feedback on clinical performance. The VAT can also serve as subject matter experts to the ordering physicians for the appropriate device type, based on vessel size and indications for use, how many lumens, site selection and a de-escalation plan for the patient prior to discharge. It also provides services should a device-related complication occur (eg, clotting), and works with clinicians to remedy the issue and salvage the device, thereby preventing a patient from losing their vascular access and/or having to replace it.The last element, and perhaps most significant, is to enhance the adoption of best practices through a partnership with the key stakeholders. PICC-associated outcomes are not only owned by the VAT, rather it is the responsibility of the clinicians, physicians and nurses to achieve those goals (table 1).

Physicians are an essential stakeholder group to engage as they are the ones responsible for ordering the PICC. An identified physician champion who partners and empowers the VAT will help resolve any barriers and be a liaison with the local physician community.13 The ideal physician champion should have the respect of peers, understand process optimisation and promote quality improvement. They need to be well versed on the appropriate indications for PICC use, the associated complications and risks and alternatives to the device. The physician champion engages the leaders of the key disciplines responsible for requesting a PICC, educating them on the appropriate indications for use, the outcomes associated with PICC use, inviting them to be partners and responding to any of their concerns.View this table:Table 1 Disciplines and their support to mitigate PICC harmWhat about the key physician disciplines to engage?.

Physicians can play an active role in enhancing PICC use through avoiding the unnecessary use of infusions. The consultation of infectious diseases specialists for intravenous antibiotic use appropriateness has been associated with less PICC use and lower complications.14 Similarly, having a surgeon support the decision for whether enteral or parenteral nutrition is needed will help reduce unnecessary device use.15 Disciplines like hospitalists or general internists care for a large number of patients and often order PICCs for venous access,16 while nephrologists may advocate avoiding the use of PICCs in the chronic kidney disease population in an effort for vein preservation.17 In hospitals with teaching programmes, the VAT and its physician champion may educate physicians in training on device choice, placement and duration of use, and address with their faculty competencies for line management.18 Engaging these disciplines, elucidating the indications for appropriate use and providing feedback and local data on the potential harm ensure accountability and further attention to PICC safety.In summary, the PICC is one of the primary solutions to achieve vascular access. With up to one in five patients at risk for developing complications,19 it is incumbent on us to ensure that these devices are properly used and maintained. Identifying and overcoming system barriers are key to delivering sustainable safe outcomes.

As a first step, clinical and administrative leaders, realising the financial and quality benefits, need to support the structure reflected by the VAT to enhance PICC care. Second, the VAT must partner with disciplines (particularly nursing) to promote and ensure adequate competencies for placement and maintenance. Finally, clinical disciplines caring for the patient should instil a collaborative environment for better decision-making on when central access is required, and what device provides the safest and most effective delivery of care.Ethics statementsPatient consent for publicationNot required..

Patients are more likely to experience preventable harm during perioperative care than in any other type of healthcare encounter.1 2 For several decades, a hallmark of surgical quality and safety has been the use of checklists to zithromax 500mg for sale prevent errors (eg, wrong site surgery) and assure pop over to this web-site that key tasks have been or will be performed. The most widely used approach globally is the Surgical Safety Checklist (SSC) recommended by the WHO.3 It is divided into preinduction zithromax 500mg for sale (or sign in, consisting of seven items performed by anaesthesia and nursing), preincision (timeout, 10 items performed by the entire team) and postsurgery (sign out, five items by the entire team).4 5 Most hospitals in the developed world perform the SSC or an equivalent timeout prior to surgical incision. However, preinduction briefings, and postcase debriefings in particular, are much less commonly performed.6 7There are widely disseminated arguments recommending the use of checklists in healthcare8 but also recognised limitations.9 Checklist-based preincision timeouts appear to improve surgical outcomes in many settings,4 5 yet, in other hospitals, the introduction of the SSC failed to improve outcomes.10 Like all tools or processes intended to improve safety, ineffective implementation will reduce the desired benefits. For example, there is appreciable evidence showing that surgical teams skip or do not meaningfully respond to timeout checklist items.11 12 Even with a robust implementation, effectiveness can be weakened by contextual factors, failure of leadership or deficient zithromax 500mg for sale safety culture.Despite numerous studies, gaps in the evidence to guide optimal checklist use persist. For example, we do not know whether checklist-based timeouts only decrease the occurrence of the undesirable events targeted by the checklist or, as many hypothesise, whether their use also facilitates teamwork and interprofessional communication.

Although there is increasing guidance on how to optimally implement checklists at the local level, many questions remain.13 Moreover, we still do not understand the circumstances in which checklist use facilitates the detection, reporting and correction of zithromax 500mg for sale errors.In this issue of the journal, Muensterer and colleagues14 describe a clever study in which the attending surgeon intentionally introduced errors during the preincision timeout while a medical student in the operating theatre surreptitiously noted whether the error was detected and reported by one or more members of the surgical team. If the error was not verbalised, the attending surgeon corrected the error before the timeout was complete. The single error zithromax 500mg for sale embedded in each of 120 of 1800 paediatric operations was randomly chosen from among wrong patient name, age, gender, allergy or surgical procedure, side or site. Overall, only about half (65. 54%) of all zithromax 500mg for sale errors were detected and reported by a team member prior to surgeon correction.

Of these, errors were most commonly reported by the anaesthesiologist (64%) and almost never by residents in training (6%) or medical students (1%).This study also has important limitations. Because the investigators were leading the timeouts as part of a research study, adherence to all of the checklist zithromax 500mg for sale items was reportedly 100%. Yet, few organisations consistently attain timeout adherence above 90%.11 Since you are less likely to catch an error if you do not address that item during the timeout, in institutions with lower adherence, the proportion of missed errors may be even higher.The authors, with input from their institutional review board, designed the study to be feasible and compliant with established human subjects protection principles. As such, the attending surgeon always corrected the error after the anaesthesiologist’s component of the timeout but before the nurses’ zithromax 500mg for sale component. By excluding the part of the timeout when the nurses address their checklist items (eg, instruments are sterile,) followed by a final opportunity as the timeout ends to note any errors or concerns, the study may have underestimated the rate of error reporting.Because the study did not query team members individually after the timeout, we also do not know how many errors were detected but not annunciated.

For example, recognised errors that were attributed to ‘misspeaking’ and/or had no clinical significance may not have been zithromax 500mg for sale verbally challenged. Moreover, as is discussed by the authors, there was an unequivocal hierarchy effect—individuals with the least ‘power’ (ie, low in hierarchy within the current healthcare culture) were the least likely to report the error.This study highlights two important safety relevant questions on which I will elaborate. First, why zithromax 500mg for sale and how should we change healthcare culture to facilitate ‘speaking up’?. Second, how can we best design and implement checklists and other safety interventions to yield more consistent and sustained clinician behaviour change?. The continued problem of hierarchical culture in healthcareThe significant influence of hierarchy on the incidence of error reporting in Muensterer et al’s14 study is consistent with substantial prior evidence that lower hierarchy clinical providers are less likely to ‘speak up’, even when they are aware of major safety violations.15–17Failure of a subordinate copilot to challenge or speak up to the captain in the 1977 Tenerife disaster was the impetus zithromax 500mg for sale for the aviation industry’s adoption of crew resource management (CRM).

Healthcare team-training initiatives like the Agency for Healthcare Research and Quality’s TeamSTEPPS now include tools such as the ‘two-challenge rule’ and emphasise speaking up.18 Flattened hierarchies and reliance on expertise rather than seniority, especially during crisis or stress, are an integral component of high-reliability organisations. In contrast, zithromax 500mg for sale the persistent hierarchical culture of healthcare is anathema to positive safety attitudes and behaviours. This is particularly problematic in operating theatres where surgeons view themselves as ‘captain of the ship’ and where uncivil behaviour is tolerated.19 The insidious effects of hierarchy will impair effectiveness of checklist use and predispose to safety issues in all aspects of routine and emergency care.20 While team-oriented training designed to enhance the ability of lower hierarchy clinicians to ‘speak up’ can be effective,21 22 evidence to guide the design and implementation of these interventions is still sparse. Single training exposures have generally had limited effects,17 23 in part likely due to inadequate ‘potency’ to achieve the desired effect24 in a clinical environment contaminated by the zithromax 500mg for sale hierarchical culture and in part because most interventions have focused on ‘assertiveness’ training for the less powerful members of the team rather than, or in addition to, sensitivity or receptivity training of the most powerful (eg, surgical attendings).17Discussions of power hierarchy to date have largely focused on clinicians’ professional roles (ie, nurse vs physician) and level of experience (eg, resident vs attending). Even with two attending physicians, for example, a surgeon and anaesthesiologist, power dynamics can degrade communication and decrease team performance.

In a multicentre study of experienced anaesthesiologists managing simulated crisis events, the anaesthesiologists’ failure to challenge the surgeon to initiate life-saving interventions (eg, to open the abdomen in the presence of an enlarging retroperitoneal haematoma during laparoscopic surgery, or to halt surgery to cardiovert an unstable patient) was associated with lower overall scenario performance scores as determined by trained blinded anaesthesiologist video raters.25In fact, hierarchy is much more complex and this may explain in part the variable and generally weak results seen in ‘speaking up’ intervention studies zithromax 500mg for sale to date. When considering hierarchical effects on communication assertiveness, one must also consider individual characteristics including gender, race/ethnicity, language, personal cultural background and personality, as well as the personality of those in higher power roles, microclimate factors of the team and care unit, and overall organisational culture.17 22 An interesting direction for future study is the facilitation of more positive communication (eg, expressions of gratitude or encouragement).26In a single-site intervention study to improve the quality of handovers from anaesthesia professionals to postanaesthesia care unit (PACU) nurses,27 simulation-based training emphasised specific dyadic communication behaviours—assertiveness for the nurses when their needs were not being met and ‘sensitivity’ (or receptiveness) for the anaesthesia professionals when the nurses raised concerns. In poststudy interviews, this behavioural focus zithromax 500mg for sale was considered an important contributor to the resulting sustained improvement in the quality of actual handovers. As part of this study, we explicitly taught participants to CUSS. CUSS is a graduated approach to facilitate speaking zithromax 500mg for sale up.

The acronym stands for ‘I’m Concerned’, ‘I’m Uncomfortable’, ‘This is a Safety issue’ and ‘Stop!. €™. The intended learners were taught these ‘triggers’ for eliciting desired behaviours (ie, to stop what they are doing and have a conversation with the initiator) and this approach creates an environment where the initiating individual can receive support from others who overhear the conversation—‘Doctor, I hear that Maria is CUSSing at you?. How can I help to resolve this situation?. €™ Such a graded assertiveness approach to ‘stop the line’, developed in other industries, is increasingly being used throughout healthcare.28Designing and implementing more effective safety tools and processesSSCs are just one tool used to advance overall perioperative system safety.

Similarly, in commercial aviation, checklists are one tool used as part of CRM to assure operational safety. CRM is a philosophy or construct that includes explicit values and principles, procedures supported by purpose-designed checklists and other tools, and regularly scheduled mandatory simulation-based training and assessment that together contribute to an existing safety culture in pilots and across the organisation.29 CRM and most of the existing aviation safety system were iteratively designed by pilots (the front-line workers) in collaboration with other stakeholders (including regulators). Healthcare must employ similar human-centred design approaches to re-engineer our safety systems.For commercial aviation to be completely safe, no planes would fly. Similarly, safety will never be the foremost system objective in healthcare. The primary goal is to efficiently deliver cost-effective care.

Instead, in any high-consequence industry, safety is a desirable by-product (an ‘emergent feature’) of a system designed to achieve primary operational goals. In healthcare, sick patients must be treated and there is inherent risk in doing so.30 Achieving societally acceptable levels of safety will stem from a deliberately designed system founded on a strong safety culture and truly committed leadership.With this as background, it is not surprising that so many hospitals struggle to garner reliable and sustained benefit from the use of checklists and other safety tools. To understand what is required, I would like to draw parallels with anaesthesiology’s experience of implementing another type of checklist.The Food and Drug Administration Anesthesia Machine Pre-Use ChecklistThe earliest checklist used in healthcare to reduce adverse events is the anaesthesia equipment preuse checklist, developed in 1987 by the US Food and Drug Administration (FDA) in collaboration with the Anesthesia Patient Safety Foundation and the American Society of Anesthesiologists.31 After more than three decades of use, lessons learnt from the use of the FDA checklist parallel more recent experiences with SSCs, and are instructive to a more general understanding of the role of safety tools in healthcare (see table 1).View this table:Table 1 Lessons learnt from 30 years of personal experience with and reflection about the Anesthesia Equipment Pre-Use Checklist*A checklist alone is insufficient to achieve optimal resultsHospitals that get the best results from an SSC implementation are often well-resourced organisations that already have safety-oriented committed leadership, a strong safety culture, educated and engaged front-line clinicians and an established track record of successfully implementing other safety interventions.32 That said, any hospital, given adequate commitment, resources and expertise, can implement an SSC or other substantive safety intervention successfully. In doing so, it will educate and engage its workers, improve its safety culture and set the stage for further safety and quality improvements.A multimodal approach to safety interventions is more effective. Hospitals that were able to successfully implement all three components of the SSC saw greater reductions in postoperative complications.33 Similarly, the combination of the SSC with a complementary approach that more fully addresses preoperative and postoperative issues, the Surgical Patient Safety System, was associated with better postoperative outcomes than use of the WHO SSC alone.34 The most effective interventions are those that are based on an integrated conceptual framework and follow human factor principles, especially when the safety goals are multiple or diverse.35In our PACU handover improvement project mentioned earlier,27 the multimodal intervention produced a fourfold improvement in observed clinician behaviours (ie, conduct of actual handovers) that was sustained for at least 3 years after the intervention ceased.

The project began by getting perioperative leadership buy-in, conducting observations of the current handover process and engaging front-line clinicians in all phases of study development. The criteria for an ‘acceptable handover’ were chosen by an independent team of clinicians. Front-line clinicians first completed a multimedia introductory webinar that included key principles and a knowledge assessment. To attend the 2-hour simulation training session, both anaesthesia professionals and PACU nurses were relieved from regular clinical duties (a strong message that this was an organisational priority). A custom patient-specific electronic form was available at every bedside in the PACU to reinforce the training during actual handovers.

Performance feedback was provided to individuals, units and perioperative leadership. The number of components needed for successful safety interventions will depend on the behaviour change desired, the existing safety culture, current experience and expertise of the intended end users and the priority articulated by organisational leaders. Regardless, design and implementation must be based on a solid conceptual framework, consider the full life-cycle of the intervention (from conceptualisation to obsolescence) and employ human factors engineering and implementation science principles and tools.13ConclusionChecklists and other safety tools are potentially valuable tools to advance perioperative safety. However, when used in isolation or implemented incorrectly, checklists have significant limitations. Safety initiatives that take a systems-oriented multimodal approach to design and implementation can, with organisational leadership and determination, produce both targeted and more general safety improvement.Ethics statementsPatient consent for publicationNot required.Many patients admitted to hospital require venous access to infuse medications and fluids.

The most commonly used device, the peripheral venous catheter, ranges from 2.5 to 4.5 cm in length, and is typically used for less than 5 days. The midline, a relatively newer peripheral venous catheter, is up to 20 cm in length, but does not reach the central veins, and may be used for up to 2 weeks. A peripherally inserted central venous catheter (PICC) is a longer catheter that is placed in one of the arm veins and extends to reach the central veins. The PICC is used for longer periods of time compared with peripheral intravenous devices, and initially gained popularity as a convenient vascular access device used in the outpatient and home settings. Its premise has been to provide access that lasts for weeks, that is fairly safe and easily manageable.

Patients often require central venous access when hospitalised, with more than half of patients in intensive care, and up to 20% in those cared for in the non-intensive care wards.1 Common indications for PICC use in the acute care setting include the requirement for multiple and frequent infusions (eg, antibiotics, parenteral nutrition), the administration of medications incompatible with peripheral infusion, invasive haemodynamic monitoring in critically ill patients, very poor venous access and frequent need for blood draws.2 Specially trained healthcare workers place PICCs, often nurses from a vascular access team (VAT), or interventional radiologists. The VAT is comprised of skilled nurses, with either medical/surgical, emergency department or intensive care unit backgrounds. Contrary to other healthcare workers that place PICCs, the VAT’s primary function is to place PICCs, and optimise the infusion delivery, through a safe and effective process. Its scope includes assessment for need, peripheral and central device insertion, monitoring of use and removal.3In their study of five hospitals within the Veterans Administration (VA) healthcare systems in the USA, Krein et al4 underscore the importance of a formal VAT to formulate and implement explicit appropriateness criteria, ensure timely insertion and safe management and direct patient education around PICC use. They found that team structures supporting line placement vary across hospitals from a dedicated team, to individual nurses trained in placement, to hospitals where only interventional radiologists insert PICCs.

The presence of a VAT was associated with more defined criteria for PICC use, but a recurrent theme was inadequate interdisciplinary dialogue. Although qualitative data were gathered at five VA hospitals only, the study’s findings reflect the variation in PICC placement and use, whether in academic or community, small or large hospitals.An important factor in variation in the approach to PICC line placement and management is the availability of resources and expertise at the hospital site. For example, if healthcare workers have suboptimal skills to place peripheral venous catheters, including midlines,5 clinicians may resort to ordering more PICCs unnecessarily to fill that void. Furthermore, as revealed in Krein’s study, a hospital that does not have the expertise to learn about alternative devices, such as those with lower risks and shorter dwell times (eg, midlines), may resort to using more PICCs than necessary. Similarly, hospitals without clinicians skilled or comfortable placing other central lines6 may rely more on using PICCs.

In addition, the lack of an available VAT to place PICCs using uasound guidance may result in more referrals to interventional radiology for placement, potentially exposing the patient to avoidable radiation during fluoroscopy.7We propose an approach to improve the appropriate and safe use of PICCs by focusing on three elements that address the findings by Krein and colleagues. Establishing a structure powered by a VAT. Anchoring a standardised process for line selection, insertion and care. And promoting adoption by engagement with the key stakeholders.Establishing a structure to support placement and management of PICCs depends on whether the number of devices placed is enough to support the creation of a dedicated vascular access programme. Leadership plays a critical role to invest the resources for a functional VAT, understanding the financial and quality benefits associated.8 Not realising its value, hospital leaders may view the VAT as a non-revenue-generating service, putting it at risk when considering cost reduction strategies.

The value of the VAT expands from mitigating preventable events (eg, deep venous thrombosis, ) to enhancing patient experience (eg, less attempts to place a peripheral device).9 In addition, better outcomes help curb the financial risks (eg, hospital-acquired condition penalties)8 and improve hospital ratings. The VAT’s role encompasses placing PICCs and guaranteeing the proper selection of the intravascular device and its appropriate use.2The second element involves standardising processes for line selection and care, regardless of who is taking care of the device. Implementing policies to address indications, placement and maintenance and using standardised kits help minimise variation. The creation of policies should be achieved through a multidisciplinary approach with VAT, nurses and physicians. The VAT can act as the ‘gate keeper’ evaluating whether the reason for PICC placement is aligned with indications.

In addition, the VAT plays a critical role supporting nurses’ competencies for venous catheter use (eg, aseptic access and maintenance, addressing complications and mitigating risk)10 to reduce mechanical11 and infectious complications.12 The VAT performs regular rounds to mitigate process gaps (eg, dressing site intactness) and to identify complications (eg, PICC site erythema or drainage, arm swelling), and provides timely feedback on clinical performance. The VAT can also serve as subject matter experts to the ordering physicians for the appropriate device type, based on vessel size and indications for use, how many lumens, site selection and a de-escalation plan for the patient prior to discharge. It also provides services should a device-related complication occur (eg, clotting), and works with clinicians to remedy the issue and salvage the device, thereby preventing a patient from losing their vascular access and/or having to replace it.The last element, and perhaps most significant, is to enhance the adoption of best practices through a partnership with the key stakeholders. PICC-associated outcomes are not only owned by the VAT, rather it is the responsibility of the clinicians, physicians and nurses to achieve those goals (table 1). Physicians are an essential stakeholder group to engage as they are the ones responsible for ordering the PICC.

An identified physician champion who partners and empowers the VAT will help resolve any barriers and be a liaison with the local physician community.13 The ideal physician champion should have the respect of peers, understand process optimisation and promote quality improvement. They need to be well versed on the appropriate indications for PICC use, the associated complications and risks and alternatives to the device. The physician champion engages the leaders of the key disciplines responsible for requesting a PICC, educating them on the appropriate indications for use, the outcomes associated with PICC use, inviting them to be partners and responding to any of their concerns.View this table:Table 1 Disciplines and their support to mitigate PICC harmWhat about the key physician disciplines to engage?. Physicians can play an active role in enhancing PICC use through avoiding the unnecessary use of infusions. The consultation of infectious diseases specialists for intravenous antibiotic use appropriateness has been associated with less PICC use and lower complications.14 Similarly, having a surgeon support the decision for whether enteral or parenteral nutrition is needed will help reduce unnecessary device use.15 Disciplines like hospitalists or general internists care for a large number of patients and often order PICCs for venous access,16 while nephrologists may advocate avoiding the use of PICCs in the chronic kidney disease population in an effort for vein preservation.17 In hospitals with teaching programmes, the VAT and its physician champion may educate physicians in training on device choice, placement and duration of use, and address with their faculty competencies for line management.18 Engaging these disciplines, elucidating the indications for appropriate use and providing feedback and local data on the potential harm ensure accountability and further attention to PICC safety.In summary, the PICC is one of the primary solutions to achieve vascular access.

With up to one in five patients at risk for developing complications,19 it is incumbent on us to ensure that these devices are properly used and maintained. Identifying and overcoming system barriers are key to delivering sustainable safe outcomes. As a first step, clinical and administrative leaders, realising the financial and quality benefits, need to support the structure reflected by the VAT to enhance PICC care. Second, the VAT must partner with disciplines (particularly nursing) to promote and ensure adequate competencies for placement and maintenance. Finally, clinical disciplines caring for the patient should instil a collaborative environment for better decision-making on when central access is required, and what device provides the safest and most effective delivery of care.Ethics statementsPatient consent for publicationNot required..

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In this issue of BMJ Quality and Safety, Jorro-Barón and colleagues1 report the findings of a stepped-wedge cluster randomised trial (SW-CRT) to evaluate the implementation of the I-PASS handover system among six paediatric intensive care units (PICUs) at five Argentinian hospitals between July 2018 and May goodrx coupon zithromax 2019. According to the authors, prior to the intervention there were complaints goodrx coupon zithromax that handovers were ‘…lengthy, disorganized, …participants experienced problems with interruptions, distractions, and … senior professionals had problems accepting dissent’.Adverse events were assessed by two independent reviewers using the Global Assessment of Pediatric Patient Safety instrument. Study results demonstrated significantly improved handover compliance in the intervention group, validating Kirkpatrick Level 3 (behavioural change)2 effectiveness of the training initiative. Notably, however, on the primary outcome there were no differences between control and intervention goodrx coupon zithromax groups regarding preventable adverse events per 1000 days of hospitalisation (control 60.4 (37.5–97.4) vs intervention 60.4 (33.2–109.9), p=0.998, risk ratio. 1.0 (0.74–1.34)).

Regarding balancing measures, there was no observed goodrx coupon zithromax difference in the ‘full-shift’ handover duration (control 35.7 min (29.6–41.8). Intervention 34.7 min (26.5–42.1), p=0.490), although more time was spent on individual patient handovers in the intervention period (7.29 min (5.77–8.81). Control 5.96 min (4.69–7.23) goodrx coupon zithromax. P=0.001). From the provider perspective, preintervention and postintervention Agency for Healthcare Research and Quality (AHRQ) safety culture surveys did not show significant differences in their responses to communication-focused questions before and after the intervention.Thus, consistent with all previous studies, I-PASS was implemented successfully and handover quality improved.

However, is the lack of association of I-PASS implementation with clinical outcomes and adverse events in this study a concern?. To answer this question, it is necessary to review the origins of I-PASS more than a decade ago and its continually expanding evidence base.Healthcare has a handover problemHandovers are among the most vulnerable reoccurring processes in healthcare. In the AHRQ safety culture survey,3 the handovers and transitions of care domain is consistently among the lowest scoring, and handover and communication issues are among the most common cause of Joint Commission Sentinel Events and the subject of Joint Commission Sentinel Event Alert Issue 58.4 A study by CRICO Strategies found that communication issues were a factor in 30% of 23 658 malpractice claims filed from 2009 to 2013, accounting for $1.7 billion in incurred losses.5 The importance of handovers and care transitions for trainees is specifically discussed in a Clinical Learning Environment Review Issue Brief published by the Accreditation Council for Graduate Medical Education (ACGME),6 and Section VI.E.3 (Transitions of Care) of the ACGME Common Program Requirements (Residency) addresses the requirement for residents to be taught and to use structured handovers.7Both the numbers of handovers and handover-related problems have increased in contemporary practice because of greater patient complexity and the expanding number and types of providers involved in a typical patient’s care. Further, in teaching institutions, resident work-hour restrictions have resulted in the need for complex coverage schemes. Off-hours care is often provided by ‘cross-covering’, ‘float’ or ‘moonlighting’ practitioners who are responsible for numerous unfamiliar patients during their shifts, thus imposing an even greater need for effective handovers.

The net effect of all these changes may be inconsistent, fragmented care resulting from suboptimal handovers from one provider, service or hospital to another, with resulting medical errors (often of omission) and adverse events.Structured, standardised handoversThese serious vulnerabilities have led to pleas for more consistent, structured and standardised handovers.8–11 In addition to their use in routine shift-to-shift provider sign-off, these may be of particular value in the high-risk transfers of critically ill patients, such as from operating rooms to postoperative care units and ICUs12–16. Admissions to a surgery unit17. Management of trauma patients18–20. ICU to general ward transfers21 22. Night and weekend coverage of large services, many of whose patients are unfamiliar to the physician receiving the handover23–28.

And end-of-rotation resident transitions.29–31Given these considerations, standardised handovers, often involving mnemonic devices, have been widely advocated and studied in the past several decades, though many lack rigorous evaluation and few if any showed demonstrable associations with outcomes.32 33 Further, although some individual hospitals, units and services have implemented their own idiosyncratic handover systems, this does not solve the issue of handover inconsistency between different care delivery sites. A basic, common framework that could be customised to individual use cases would clearly be preferable.The I-PASS systemResponding to these concerns, the I-PASS Study Group was initiated in 2009 and the I-PASS Institute in 2016. Although numerous other systems are available, since its pilot studies a decade ago,34 35 I-PASS has emerged as the dominant system in healthcare for structured, standardised handovers. This system is specifically designed for healthcare applications. It is based on adult educational principles and simple to use.

It has been extensively validated in the peer-reviewed literature encompassing studies at multiple institutions in the USA and internationally34–40. And extensive training materials are available to assist programmes in implementation.39 41–45 Ideally, this system is implemented hospital-wide, which addresses the issue of cross-unit and cross-service transfers.I-PASS includes five major elements regarded as important for every handover—illness severity, patient summary, action list, situation awareness/contingency planning and synthesis by receiver. The first three of these elements are often included in non-structured handovers, although not necessarily in a specific sequence or format. The last two I-PASS elements—situational awareness/contingency planning and synthesis—have not historically been included in typical handover practice. The former assures that any anticipated problems are conveyed from the handover giver to the incoming provider and that appropriate responses to these issues are discussed.

Synthesis is closed-loop communication, with brief read-back of the handover information by the receiver to assure their accurate comprehension, followed by an opportunity for questions and discussion. This read-back of mission-critical communications is standard operating practice in other high-reliability settings such as aviation, the military and nuclear power. It is essential to establishing a shared mental model of the current state and any potential concerns. However, other than in I-PASS, it is quite uncommon in healthcare, with the potential exception of confirming verbal or telephonic orders.I-PASS validationIn an initial study of I-PASS handover implementation by residents on two general inpatient paediatric units at Boston Children’s Hospital,34 written handovers were more comprehensive and had fewer omissions of key data, and mean time spent on verbal handover sessions did not change significantly (32.3 min vs 33.2 min). Medical errors and adverse events were ascertained prospectively by research nurse reviewers and independent physician investigators.

Following I-PASS implementation, preventable adverse events decreased from 3.3 (95% CI 1.7 to 4.8) to 1.5 (95% CI 0.51 to 2.4) per 100 admissions (p=0.04), and medical error rates decreased significantly from 33.8 per 100 admissions (95% CI 27.3 to 40.3) to 18.3 per 100 admissions (95% CI 14.7 to 21.9. P<0.001). A commentary by Horwitz46 noted that this was ‘…by far the most comprehensive study of the direct effects of handoff interventions on outcomes within the context of existing work-hour regulations and is the first to demonstrate an associated significant decrease in medical errors on a large scale’, while also noting limitations including its uncontrolled, ‘before and after’ design, confounding by secular changes, Hawthorne effects and inability to blind the nurses collecting adverse event data.The more expansive, landmark I-PASS study was conducted by Starmer and colleagues37 among nine paediatric hospitals and 10 740 patient admissions between January 2011 and May 2013. Handover quality was evaluated, and medical errors and adverse events were ascertained by active surveillance, including on-site nurse review of medical records, orders, formal incident reports, nursing reports and daily medical error reports from residents. Independent physician investigators classified occurrences as adverse events, near misses or exclusions, and they subclassified adverse events as preventable or non-preventable.

Results revealed a 23% reduction in medical errors from the preintervention to the postintervention period (24.5 vs 18.8 per 100 admissions, p<0.001) and a 30% reduction in preventable adverse events (4.7 vs 3.3 events per 100 admissions, p<0.001). Inclusion of prespecified elements in written and verbal handovers increased significantly, and there was no significant change in handover time per patient (2.4 vs 2.5 min. P=0.55).Subsequent investigations in other institutions have replicated many of the findings of the original I-PASS studies, with higher postintervention inclusion rates of critical handover elements. Fewer mistakes or omissions. Greater provider satisfaction with handover organisation and information conveyed.

Unchanged or shorter handoff times. And decreased handover interruptions (probably reflecting greater attention to the importance of the handover process).36 40 47–50 In a mentored implementation study conducted in 2015–2016 among 16 hospitals (five community hospitals, 11 academic centres and multiple specialties), handover quality improved, and there was a provider-reported 27% reduction in adverse events.38 Among nurses at Boston Children’s Hospital, I-PASS implementation was associated with significant decreases in handover-related care failures.40In recognition of its achievements in improving healthcare quality, the I-PASS Study Group was awarded the 2016 John M Eisenberg Award for Patient Safety and Quality by the National Quality Forum and the Joint Commission.The challenge of linking handovers to clinical outcomes and eventsAlthough investigations from many centres, including the report of Jorro-Barrón and colleagues,1 have now confirmed that I-PASS can be readily assimilated and used by clinicians, most of these have either not rigorously assessed adverse events, medical errors and other clinical outcomes (Kirkpatrick Level 4 evaluation) or have failed to demonstrate significant postintervention improvements in these clinical outcomes. Why is this, and should current or potential I-PASS users be concerned?. With regard to the first question, there are practical considerations that complicate the rigorous study of clinical outcome improvements associated with I-PASS (or any other handover system). Notwithstanding the importance of effective communications, these are only one of many provider processes and hospital systems, not to mention the overall hospital quality and safety culture, that impact a patient’s clinical outcome.

In most hospitals, a diverse portfolio of quality and safety improvement initiatives are always being conducted. Disentangling and isolating the effects of any one specific intervention, such as I-PASS handovers, is challenging if not impossible. At a minimum, it requires real-time, prospective monitoring by trained nurse or physician reviewers as in the original I-PASS studies, a research design which realistically is unlikely to be reproduced. Ideally, the study design would also include blinding of the study period (control or intervention) and blinding of observers, the former of which is virtually impossible for this type of intervention.Further, if other provider processes and hospital systems are functioning at a high level, they may partially offset the impact of suboptimal communications and make it even more challenging to demonstrate significant improvements. The current study of Jorro-Barón and colleagues,1 which uses PICUs as the unit of analysis, illustrates this concept.

PICUs are typically among the most compulsive, detail-oriented units in any hospital, even if they may have nominally ‘non-standardized’ handovers.Study design. The SW-CRTIn an attempt to address the limitations of some previous studies, Parent and colleagues51 studied eight medical and surgical ICUs across two academic tertiary teaching hospitals using an SW-CRT design. Clinician self-assessment of having been inadequately prepared for their shift because of a poor-quality handoff decreased from 35 of 343 handoffs (10.2%) in the control arm to 53 of 740 handoffs (7.2%) postintervention (OR 0.19. 95% CI 0.03 to 0.74. P=0.03).

€˜Last-minute’, early morning order writing decreased, and handover duration increased but not significantly (+5.5 min. 95% CI 0.34 to 9.39. P=0.30). As in the current study of Jorro-Barón and colleagues,1 who also employed an SW-CRT, there were no associated changes in clinical outcomes such as ICU length of stay, duration of mechanical ventilation or necessity for reintubation. The authors comment that given high baseline quality of care in these ICUs, it was not surprising that there were no changes in outcomes.An SW-CRT is generally considered a rigorous study design as it includes cluster randomisation.

However, though novel and increasingly popular, this approach is complex and may sometimes add confusion rather than clarity.52–57 Its major appeal is that all clusters will at some point, in a random and sequential fashion, transition from control to intervention condition. For an intervention that is perceived by participants as having more potential for good than harm, this may enhance cluster recruitment. It may also make it possible to conduct a randomised study in scenarios where pragmatic considerations, such as the inability to conduct interventions simultaneously across numerous clusters, may make a parallel randomised study (or any study) infeasible.However, as acknowledged even by its proponents, the added practical and statistical complexity of SW-CRTs often makes them more challenging to properly implement, and compared with traditional parallel cluster randomised trials they may be more prone to biases.53–57 A Consolidated Standards of Reporting Trials extension has been specifically developed in response to these concerns.55 Unique design and analytical considerations include the number of clusters, sequences and periods. Clusters per sequence. And cluster-period sizes.55 56 Concerns include recruitment and selection biases.

Proper accounting for secular trends in outcomes (ie, because of the sequential rather than simultaneous nature of the SW-CRT design, observations from the intervention condition occur on average at a later calendar time, so that the intervention effect may be confounded by an underlying time trend). Accounting for repeated measures on participants and clusters in sample size calculations and analyses (ie, data are not independent). Possible time-varying treatment effects. And the potential for within-cluster contamination of observations obtained under the control or intervention condition.52–56Regarding contamination, a secular trend may be responsible if, for example, institutional activities focused on improving patient outcomes include a general emphasis on communications. There might also be more direct contamination of the intervention among clusters waiting to be crossed over, as described in the context of the Matching Michigan programme.58 Participating in a trial and awareness of being observed may change the behaviour of participants.

For example, in the handover intervention of Jorro-Barón and colleagues,1 some providers in a control condition cluster may, because they are aware of the interest in handovers, begin to implement more standardised practices before the formal shift to the intervention condition. This potentially dilutes any subsequent impact of the intervention by virtue of what could be considered either a Hawthorne effect or a local secular trend, in either case leading to generally better handovers in the preintervention period. Some SW-CRTs include a transition period without any observations to allow for sufficient time to implement the intervention,53 59 thereby creating more contrast. Finally, because of sometimes prolonged PICU length of stay and regularly scheduled resident rotations on and off a unit or service, some patients and providers might overlap the transition from control to intervention state and contribute observations to both, while others will be limited to one or the other. This possibility is not clearly defined by the authors of the current study, but seems unlikely to have had a major statistical effect.Do we need more evidence?.

From an implementation science perspective, handovers are a deeply flawed healthcare process with the demonstrated potential to harm patients. A new tool—I-PASS—has been developed which can be easily and economically taught and subsequently applied by virtually any provider, and many resources are available to assist in implementation.45 It has few, if any, unintended negative consequences to patients or providers and has been associated in at least two extensive and well-conducted (although non-randomised) trials with dramatic reductions in medical errors and adverse events. Notably, these were conducted at a time when there was much less emphasis on and awareness of handover systems, including I-PASS. Thus, there was much greater separation between control and intervention states than would be possible today.Returning to the question posed at the beginning of this commentary, is the inability to demonstrate a favourable impact on clinical outcomes in studies other than those of the developers34 35 a reason to question the value of I-PASS?. For the reasons discussed above, I think not.

In his classic 2008 article,60 ‘The Science of Improvement’, Dr Don Berwick recounts the transformational development of sophisticated statistical analyses in healthcare, of which the randomised clinical trial is the paradigm. While in many instances randomised controlled trials have been invaluable in scientifically affirming or rejecting the utility of specific treatments or interventions, their limitations are more obvious in interventions involving complex social and behavioural change. Berwick illustrates this challenge with the example of hospital rapid response teams, whose benefit was challenged by the results of a large cluster randomised trial. His comments regarding that conflict are equally applicable to the current challenge of demonstrating the impact of standardised handovers on clinical outcomes:These critics refused to accept as evidence the large, positive, accumulating experience of many hospitals that were adapting rapid response for their own use, such as children’s hospitals. How can accumulating local reports of effectiveness of improvement interventions, such as rapid response systems, be reconciled with contrary findings from formal trials with their own varying imperfections?.

The reasons for this apparent gap between science and experience lie deep in epistemology. The introduction of rapid response systems in hospitals is a complex, multicomponent intervention—essentially a process of social change. The effectiveness of these systems is sensitive to an array of influences. Leadership, changing environments, details of implementation, organizational history, and much more. In such complex terrain, the RCT is an impoverished way to learn.

Critics who use it as a truth standard in this context are incorrect.Having personally observed the value of I-PASS, as well as the devastating consequences of inadequate handovers, I vote with Dr Berwick. The evidence for effectiveness is overwhelming and the need for action is urgent—all that is lacking is the will to implement.Ethics statementsPatient consent for publicationNot required.Palliative care is associated with improved patient-centred and caregiver-centred outcomes, higher-quality end-of-life care, and decreased healthcare use among patients with serious illness.1–3 The Centre to Advance Palliative Care has established a set of recommended clinical criteria (or ‘triggers’), including a projected survival of less than 1 year,4 to help clinicians identify patients likely to benefit from palliative care. Nevertheless, referrals often occur within the last 3 months of life5 due in part to clinician overestimation of prognosis.6 A growing number of automated predictive models leverage vast data in the electronic medical record (EMR) to accurately predict short-term mortality risk in real time and can be paired with systems to prompt clinicians to refer to palliative care.7–12 These models hold great promise to overcome the many clinician-level and system-level barriers to improving access to timely palliative care. First, mortality risk prediction algorithms have been shown to outperform clinician prognostic assessment, and clinician–machine collaboration may even outperform both.13 Second, algorithm-based ‘nudges’ that systematically provide prognostic information could address many cognitive biases, including status quo bias and optimism bias,14 15 that make clinicians less apt to identify patients who may benefit from palliative care. Indeed, such models have been shown to improve the frequency of palliative care delivery and patient outcomes in the hospital and clinic settings.9 16 17 With that said, successful implementation of automated prognostic models into routine clinical care at scale requires clinician and patient engagement and support.In this issue of BMJ Quality &.

Safety, Saunders and colleagues report on the acceptability of using the EMR-based Modified Hospitalised-Patient One-Year Mortality Risk (mHOMR) score to alert clinicians to individual patients with a >21% risk of dying within 12 months. The goal of the clinician notification of an elevated risk score was to prompt clinicians to consider palliative care referral.18 In a previously reported feasibility study among 400 hospitalised patients, use of the mHOMR alert was associated with increased rates of goals of care discussions and palliative care consultation in comparison to the preimplementation baseline (34% vs 18%, respectively).19 In the present study, the authors conducted qualitative interviews pre-mHOMR and post-mHOMR implementation among 64 stakeholders, including patients identified at high risk by the mHOMR algorithm, their caregivers, staff and physicians. Thirty-five (55%) participants agreed that the mHOMR tool was acceptable. 14 (22%) were unsure or did not agree. And 15 (23%) did not respond.

Participants identified many potential benefits of the programme, citing the advantages of an automated approach to facilitate and justify clinical decision making. Participants also acknowledged possible barriers, particularly ‘situational challenges’ such as the content, timing and mechanism of provider notification. Additional logistical concerns included alert fatigue, potential redundancy, uncertainty regarding next steps and a worry that certain therapeutic options could be withheld from flagged patients. The authors concluded that clinicians and patients found the automated prognostic trigger to be an acceptable addition to usual clinical care.Saunders et al’s work adds to our understanding of critical perceptions regarding end users’ acceptability of automated prognostic triggers in routine clinical care. The findings from this study align with prior evidence suggesting that clinicians recognise the value of automated, algorithm-based approaches to improve serious illness care.

For example, in a qualitative study of clinicians by Hallen et al, prognostic models confirmed clinicians’ gestalt and served as a tool to help communicate prognosis to patients.20 Clinicians described prognostic models as a tool to facilitate interclinician disagreements, mitigate medicolegal risk, and overcome the tendency to ignore or overestimate prognosis.20 Clinicians also reported that EMR-generated lists of high-risk patients improved their ability to identify potential palliative care beneficiaries in a mixed-methods study by Mason et al.21 In a single-centre pilot study, we similarly found that most clinicians believed that using an EMR-based prognostic model to encourage inpatient palliative care consultation was acceptable.9 However, in the Saunders et al study, as in prior similar work, clinicians highlighted the importance of delivering notifications without causing excess provider workload, redundancy or alert fatigue.16 18 21 Clinicians also raised concerns regarding the accuracy of the prognostic information and the potential for negative effects on patients due to common misperceptions about palliative care being equivalent to hospice.18 20 21 Ultimately, Saunders et al’s work complements and builds on existing literature, demonstrating a general perception that integration of automated prognostic models into routine clinical care could be beneficial and acceptable.Important gaps remain in this literature which were not addressed by the Saunders et al study. For example, there is a need to capture more diverse clinician and patient perspectives, and there was no information provided about the sociodemographic or clinical characteristics of the study participants. Additionally, important themes found in prior studies were not identified in this study. For example, two prior studies of clinicians’ perspectives on automated prognostic triggers for palliative care revealed concerns that prognosis alone may not be a sufficient surrogate indicator of actual palliative care need, or may inadvertently engender clinician overconfidence in an individual patient’s prognosis.9 21 The brevity of the interviews in Saunders et al’s study (mean. 12 min) could suggest all relevant themes may not have emerged in the data analysis.

Additionally, while the inclusion of patient and caregiver perceptions is an important addition, limited information is provided about their perspectives and whether certain themes differed among the stakeholders. In the study from Mason et al, themes unique to patients and caregivers were identified, such as hesitancy due to a lack of understanding of palliative care, a preference to ‘focus on the present’, and a worry that a clinician would not have the time to adequately address advanced care planning or palliative care during their visit.21 Healthcare systems should therefore be prepared to consider their unique workflows, patients and staff prior to implementing one of these programmes.Achieving stakeholder acceptability prior to widespread implementation is essential. An intervention should ideally undergo multiple cycles of optimisation with ongoing appraisal of patient and clinician perspectives prior to wide-scale implementation.22 23 Additionally, it is unclear whether clinicians’ acceptability of the intervention in one setting will generalise to other inpatient health settings. For instance, Saunders et al found that some providers were leery about the use of mHOMR due the need to balance the patient’s acute needs that brought them to the hospital with their long-term priorities that may be better served in the outpatient setting.18 Clinical workflows, patient acuity and patient–provider relationships are markedly different between the inpatient and outpatient settings, suggesting Saunders et al’s findings cannot be extrapolated to outpatient care. This is particularly relevant as many ‘off-the-shelf’ prognostic algorithms are now commercially available that, while accurate, may not be as familiar or acceptable to clinicians as a homegrown model.

Therefore, while Saunders et al’s work is a great addition to the field, additional assessments are needed across different healthcare environments and varying clinical and demographic cohorts to demonstrate that this approach is acceptable in other health settings. It is likely that multiple implementation strategies will be needed to successfully adapt automated prognostic models across a range of clinical settings.Thoughtful consideration of the many forces that alter clinical decision making will also be critical for downstream success of these interventions. Suboptimal clinical decision making is often a result of systemic biases, such as status quo and optimism bias, which result in clinician resistance to change current practice and a belief that their patients are less prone to negative outcomes.14 15 Intentional application of targeted behavioural economics principles will help ensure that the use of prognostic triggers to improve palliative care effectively changes clinical behaviour.24 For example, using an ‘opt-out’ approach for palliative care referral may make the optimal choice the path of least resistance, increasing uptake among clinicians.16 These approaches will need to be balanced against rising clinician alert fatigue25 and resource constraints.Given the implementation challenges that accompany an intervention using prognostic triggers, hybrid effectiveness trials that test both clinical effectiveness and implementation outcomes offer one strategy to advance the integration of automated prognostic models.26 Implementation outcomes are typically based on a framework which provides a systematic way to develop, manage and evaluate interventions. For example, Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) is a framework that measures the impact of a programme based on five factors. Reach, effectiveness, adoption, implementation and maintenance.27 Due to their pragmatic approach, hybrid trials frequently include heterogenous samples and clinical settings that optimise external validity and generalisability.26 28 They can be designed to primarily test the effects of a clinical interventions while observing and gathering information on implementation outcomes (type I), for equal evaluation of both the clinical intervention and implementation strategies (type II), or to primarily assess implementation outcomes while collecting effectiveness data (type III).26 29 For example, Beidas et al used a type I hybrid effectiveness–implementation trial design to test the effectiveness of an exercise intervention for breast cancer.

This study not only evaluated the effectiveness of the intervention but also identified multiple significant implementation barriers such as cost, referral logistics and patient selection challenges which informed their subsequent dissemination efforts.30 Prospective, randomised, hybrid effectiveness–implementation designs focusing on other key implementation outcomes are a logical and necessary next step in advancing the field. In total, the work by Saunders et al demonstrates the potential acceptability of an automated prognostic model to improve the timeliness of palliative care, setting the stage for further work to optimise and implement these programmes into real-world clinical care.Ethics statementsPatient consent for publicationNot required..

In this issue of BMJ Quality and Safety, Jorro-Barón and colleagues1 report the findings of a stepped-wedge cluster randomised trial (SW-CRT) to evaluate the implementation of the I-PASS handover system among six paediatric intensive care units (PICUs) at five Argentinian zithromax 500mg for sale hospitals between July 2018 and May 2019. According to the authors, prior to the intervention there were complaints that handovers were ‘…lengthy, disorganized, …participants experienced problems with interruptions, zithromax 500mg for sale distractions, and … senior professionals had problems accepting dissent’.Adverse events were assessed by two independent reviewers using the Global Assessment of Pediatric Patient Safety instrument. Study results demonstrated significantly improved handover compliance in the intervention group, validating Kirkpatrick Level 3 (behavioural change)2 effectiveness of the training initiative. Notably, however, on the primary zithromax 500mg for sale outcome there were no differences between control and intervention groups regarding preventable adverse events per 1000 days of hospitalisation (control 60.4 (37.5–97.4) vs intervention 60.4 (33.2–109.9), p=0.998, risk ratio. 1.0 (0.74–1.34)).

Regarding balancing measures, there was no zithromax 500mg for sale observed difference in the ‘full-shift’ handover duration (control 35.7 min (29.6–41.8). Intervention 34.7 min (26.5–42.1), p=0.490), although more time was spent on individual patient handovers in the intervention period (7.29 min (5.77–8.81). Control 5.96 min zithromax 500mg for sale (4.69–7.23). P=0.001). From the provider perspective, preintervention and postintervention Agency for Healthcare Research and Quality (AHRQ) safety culture surveys did not show significant differences in their responses to communication-focused questions before and after the intervention.Thus, consistent with all previous studies, I-PASS was implemented successfully and handover quality improved.

However, is the lack of association of I-PASS implementation with clinical outcomes and adverse events in this study a concern?. To answer this question, it is necessary to review the origins of I-PASS more than a decade ago and its continually expanding evidence base.Healthcare has a handover problemHandovers are among the most vulnerable reoccurring processes in healthcare. In the AHRQ safety culture survey,3 the handovers and transitions of care domain is consistently among the lowest scoring, and handover and communication issues are among the most common cause of Joint Commission Sentinel Events and the subject of Joint Commission Sentinel Event Alert Issue 58.4 A study by CRICO Strategies found that communication issues were a factor in 30% of 23 658 malpractice claims filed from 2009 to 2013, accounting for $1.7 billion in incurred losses.5 The importance of handovers and care transitions for trainees is specifically discussed in a Clinical Learning Environment Review Issue Brief published by the Accreditation Council for Graduate Medical Education (ACGME),6 and Section VI.E.3 (Transitions of Care) of the ACGME Common Program Requirements (Residency) addresses the requirement for residents to be taught and to use structured handovers.7Both the numbers of handovers and handover-related problems have increased in contemporary practice because of greater patient complexity and the expanding number and types of providers involved in a typical patient’s care. Further, in teaching institutions, resident work-hour restrictions have resulted in the need for complex coverage schemes. Off-hours care is often provided by ‘cross-covering’, ‘float’ or ‘moonlighting’ practitioners who are responsible for numerous unfamiliar patients during their shifts, thus imposing an even greater need for effective handovers.

The net effect of all these changes may be inconsistent, fragmented care resulting from suboptimal handovers from one provider, service or hospital to another, with resulting medical errors (often of omission) and adverse events.Structured, standardised handoversThese serious vulnerabilities have led to pleas for more consistent, structured and standardised handovers.8–11 In addition to their use in routine shift-to-shift provider sign-off, these may be of particular value in the high-risk transfers of critically ill patients, such as from operating rooms to postoperative care units and ICUs12–16. Admissions to a surgery unit17. Management of trauma patients18–20. ICU to general ward transfers21 22. Night and weekend coverage of large services, many of whose patients are unfamiliar to the physician receiving the handover23–28.

And end-of-rotation resident transitions.29–31Given these considerations, standardised handovers, often involving mnemonic devices, have been widely advocated and studied in the past several decades, though many lack rigorous evaluation and few if any showed demonstrable associations with outcomes.32 33 Further, although some individual hospitals, units and services have implemented their own idiosyncratic handover systems, this does not solve the issue of handover inconsistency between different care delivery sites. A basic, common framework that could be customised to individual use cases would clearly be preferable.The I-PASS systemResponding to these concerns, the I-PASS Study Group was initiated in 2009 and the I-PASS Institute in 2016. Although numerous other systems are available, since its pilot studies a decade ago,34 35 I-PASS has emerged as the dominant system in healthcare for structured, standardised handovers. This system is specifically designed for healthcare applications. It is based on adult educational principles and simple to use.

It has been extensively validated in the peer-reviewed literature encompassing studies at multiple institutions in the USA and internationally34–40. And extensive training materials are available to assist programmes in implementation.39 41–45 Ideally, this system is implemented hospital-wide, which addresses the issue of cross-unit and cross-service transfers.I-PASS includes five major elements regarded as important for every handover—illness severity, patient summary, action list, situation awareness/contingency planning and synthesis by receiver. The first three of these elements are often included in non-structured handovers, although not necessarily in a specific sequence or format. The last two I-PASS elements—situational awareness/contingency planning and synthesis—have not historically been included in typical handover practice. The former assures that any anticipated problems are conveyed from the handover giver to the incoming provider and that appropriate responses to these issues are discussed.

Synthesis is closed-loop communication, with brief read-back of the handover information by the receiver to assure their accurate comprehension, followed by an opportunity for questions and discussion. This read-back of mission-critical communications is standard operating practice in other high-reliability settings such as aviation, the military and nuclear power. It is essential to establishing a shared mental model of the current state and any potential concerns. However, other than in I-PASS, it is quite uncommon in healthcare, with the potential exception of confirming verbal or telephonic orders.I-PASS validationIn an initial study of I-PASS handover implementation by residents on two general inpatient paediatric units at Boston Children’s Hospital,34 written handovers were more comprehensive and had fewer omissions of key data, and mean time spent on verbal handover sessions did not change significantly (32.3 min vs 33.2 min). Medical errors and adverse events were ascertained prospectively by research nurse reviewers and independent physician investigators.

Following I-PASS implementation, preventable adverse events decreased from 3.3 (95% CI 1.7 to 4.8) to 1.5 (95% CI 0.51 to 2.4) per 100 admissions (p=0.04), and medical error rates decreased significantly from 33.8 per 100 admissions (95% CI 27.3 to 40.3) to 18.3 per 100 admissions (95% CI 14.7 to 21.9. P<0.001). A commentary by Horwitz46 noted that this was ‘…by far the most comprehensive study of the direct effects of handoff interventions on outcomes within the context of existing work-hour regulations and is the first to demonstrate an associated significant decrease in medical errors on a large scale’, while also noting limitations including its uncontrolled, ‘before and after’ design, confounding by secular changes, Hawthorne effects and inability to blind the nurses collecting adverse event data.The more expansive, landmark I-PASS study was conducted by Starmer and colleagues37 among nine paediatric hospitals and 10 740 patient admissions between January 2011 and May 2013. Handover quality was evaluated, and medical errors and adverse events were ascertained by active surveillance, including on-site nurse review of medical records, orders, formal incident reports, nursing reports and daily medical error reports from residents. Independent physician investigators classified occurrences as adverse events, near misses or exclusions, and they subclassified adverse events as preventable or non-preventable.

Results revealed a 23% reduction in medical errors from the preintervention to the postintervention period (24.5 vs 18.8 per 100 admissions, p<0.001) and a 30% reduction in preventable adverse events (4.7 vs 3.3 events per 100 admissions, p<0.001). Inclusion of prespecified elements in written and verbal handovers increased significantly, and there was no significant change in handover time per patient (2.4 vs 2.5 min. P=0.55).Subsequent investigations in other institutions have replicated many of the findings of the original I-PASS studies, with higher postintervention inclusion rates of critical handover elements. Fewer mistakes or omissions. Greater provider satisfaction with handover organisation and information conveyed.

Unchanged or shorter handoff times. And decreased handover interruptions (probably reflecting greater attention to the importance of the handover process).36 40 47–50 In a mentored implementation study conducted in 2015–2016 among 16 hospitals (five community hospitals, 11 academic centres and multiple specialties), handover quality improved, and there was a provider-reported 27% reduction in adverse events.38 Among nurses at Boston Children’s Hospital, I-PASS implementation was associated with significant decreases in handover-related care failures.40In recognition of its achievements in improving healthcare quality, the I-PASS Study Group was awarded the 2016 John M Eisenberg Award for Patient Safety and Quality by the National Quality Forum and the Joint Commission.The challenge of linking handovers to clinical outcomes and eventsAlthough investigations from many centres, including the report of Jorro-Barrón and colleagues,1 have now confirmed that I-PASS can be readily assimilated and used by clinicians, most of these have either not rigorously assessed adverse events, medical errors and other clinical outcomes (Kirkpatrick Level 4 evaluation) or have failed to demonstrate significant postintervention improvements in these clinical outcomes. Why is this, and should current or potential I-PASS users be concerned?. With regard to the first question, there are practical considerations that complicate the rigorous study of clinical outcome improvements associated with I-PASS (or any other handover system). Notwithstanding the importance of effective communications, these are only one of many provider processes and hospital systems, not to mention the overall hospital quality and safety culture, that impact a patient’s clinical outcome.

In most hospitals, a diverse portfolio of quality and safety improvement initiatives are always being conducted. Disentangling and isolating the effects of any one specific intervention, such as I-PASS handovers, is challenging if not impossible. At a minimum, it requires real-time, prospective monitoring by trained nurse or physician reviewers as in the original I-PASS studies, a research design which realistically is unlikely to be reproduced. Ideally, the study design would also include blinding of the study period (control or intervention) and blinding of observers, the former of which is virtually impossible for this type of intervention.Further, if other provider processes and hospital systems are functioning at a high level, they may partially offset the impact of suboptimal communications and make it even more challenging to demonstrate significant improvements. The current study of Jorro-Barón and colleagues,1 which uses PICUs as the unit of analysis, illustrates this concept.

PICUs are typically among the most compulsive, detail-oriented units in any hospital, even if they may have nominally ‘non-standardized’ handovers.Study design. The SW-CRTIn an attempt to address the limitations of some previous studies, Parent and colleagues51 studied eight medical and surgical ICUs across two academic tertiary teaching hospitals using an SW-CRT design. Clinician self-assessment of having been inadequately prepared for their shift because of a poor-quality handoff decreased from 35 of 343 handoffs (10.2%) in the control arm to 53 of 740 handoffs (7.2%) postintervention (OR 0.19. 95% CI 0.03 to 0.74. P=0.03).

€˜Last-minute’, early morning order writing decreased, and handover duration increased but not significantly (+5.5 min. 95% CI 0.34 to 9.39. P=0.30). As in the current study of Jorro-Barón and colleagues,1 who also employed an SW-CRT, there were no associated changes in clinical outcomes such as ICU length of stay, duration of mechanical ventilation or necessity for reintubation. The authors comment that given high baseline quality of care in these ICUs, it was not surprising that there were no changes in outcomes.An SW-CRT is generally considered a rigorous study design as it includes cluster randomisation.

However, though novel and increasingly popular, this approach is complex and may sometimes add confusion rather than clarity.52–57 Its major appeal is that all clusters will at some point, in a random and sequential fashion, transition from control to intervention condition. For an intervention that is perceived by participants as having more potential for good than harm, this may enhance cluster recruitment. It may also make it possible to conduct a randomised study in scenarios where pragmatic considerations, such as the inability to conduct interventions simultaneously across numerous clusters, may make a parallel randomised study (or any study) infeasible.However, as acknowledged even by its proponents, the added practical and statistical complexity of SW-CRTs often makes them more challenging to properly implement, and compared with traditional parallel cluster randomised trials they may be more prone to biases.53–57 A Consolidated Standards of Reporting Trials extension has been specifically developed in response to these concerns.55 Unique design and analytical considerations include the number of clusters, sequences and periods. Clusters per sequence. And cluster-period sizes.55 56 Concerns include recruitment and selection biases.

Proper accounting for secular trends in outcomes (ie, because of the sequential rather than simultaneous nature of the SW-CRT design, observations from the intervention condition occur on average at a later calendar time, so that the intervention effect may be confounded by an underlying time trend). Accounting for repeated measures on participants and clusters in sample size calculations and analyses (ie, data are not independent). Possible time-varying treatment effects. And the potential for within-cluster contamination of observations obtained under the control or intervention condition.52–56Regarding contamination, a secular trend may be responsible if, for example, institutional activities focused on improving patient outcomes include a general emphasis on communications. There might also be more direct contamination of the intervention among clusters waiting to be crossed over, as described in the context of the Matching Michigan programme.58 Participating in a trial and awareness of being observed may change the behaviour of participants.

For example, in the handover intervention of Jorro-Barón and colleagues,1 some providers in a control condition cluster may, because they are aware of the interest in handovers, begin to implement more standardised practices before the formal shift to the intervention condition. This potentially dilutes any subsequent impact of the intervention by virtue of what could be considered either a Hawthorne effect or a local secular trend, in either case leading to generally better handovers in the preintervention period. Some SW-CRTs include a transition period without any observations to allow for sufficient time to implement the intervention,53 59 thereby creating more contrast. Finally, because of sometimes prolonged PICU length of stay and regularly scheduled resident rotations on and off a unit or service, some patients and providers might overlap the transition from control to intervention state and contribute observations to both, while others will be limited to one or the other. This possibility is not clearly defined by the authors of the current study, but seems unlikely to have had a major statistical effect.Do we need more evidence?.

From an implementation science perspective, handovers are a deeply flawed healthcare process with the demonstrated potential to harm patients. A new tool—I-PASS—has been developed which can be easily and economically taught and subsequently applied by virtually any provider, and many resources are available to assist in implementation.45 It has few, if any, unintended negative consequences to patients or providers and has been associated in at least two extensive and well-conducted (although non-randomised) trials with dramatic reductions in medical errors and adverse events. Notably, these were conducted at a time when there was much less emphasis on and awareness of handover systems, including I-PASS. Thus, there was much greater separation between control and intervention states than would be possible today.Returning to the question posed at the beginning of this commentary, is the inability to demonstrate a favourable impact on clinical outcomes in studies other than those of the developers34 35 a reason to question the value of I-PASS?. For the reasons discussed above, I think not.

In his classic 2008 article,60 ‘The Science of Improvement’, Dr Don Berwick recounts the transformational development of sophisticated statistical analyses in healthcare, of which the randomised clinical trial is the paradigm. While in many instances randomised controlled trials have been invaluable in scientifically affirming or rejecting the utility of specific treatments or interventions, their limitations are more obvious in interventions involving complex social and behavioural change. Berwick illustrates this challenge with the example of hospital rapid response teams, whose benefit was challenged by the results of a large cluster randomised trial. His comments regarding that conflict are equally applicable to the current challenge of demonstrating the impact of standardised handovers on clinical outcomes:These critics refused to accept as evidence the large, positive, accumulating experience of many hospitals that were adapting rapid response for their own use, such as children’s hospitals. How can accumulating local reports of effectiveness of improvement interventions, such as rapid response systems, be reconciled with contrary findings from formal trials with their own varying imperfections?.

The reasons for this apparent gap between science and experience lie deep in epistemology. The introduction of rapid response systems in hospitals is a complex, multicomponent intervention—essentially a process of social change. The effectiveness of these systems is sensitive to an array of influences. Leadership, changing environments, details of implementation, organizational history, and much more. In such complex terrain, the RCT is an impoverished way to learn.

Critics who use it as a truth standard in this context are incorrect.Having personally observed the value of I-PASS, as well as the devastating consequences of inadequate handovers, I vote with Dr Berwick. The evidence for effectiveness is overwhelming and the need for action is urgent—all that is lacking is the will to implement.Ethics statementsPatient consent for publicationNot required.Palliative care is associated with improved patient-centred and caregiver-centred outcomes, higher-quality end-of-life care, and decreased healthcare use among patients with serious illness.1–3 The Centre to Advance Palliative Care has established a set of recommended clinical criteria (or ‘triggers’), including a projected survival of less than 1 year,4 to help clinicians identify patients likely to benefit from palliative care. Nevertheless, referrals often occur within the last 3 months of life5 due in part to clinician overestimation of prognosis.6 A growing number of automated predictive models leverage vast data in the electronic medical record (EMR) to accurately predict short-term mortality risk in real time and can be paired with systems to prompt clinicians to refer to palliative care.7–12 These models hold great promise to overcome the many clinician-level and system-level barriers to improving access to timely palliative care. First, mortality risk prediction algorithms have been shown to outperform clinician prognostic assessment, and clinician–machine collaboration may even outperform both.13 Second, algorithm-based ‘nudges’ that systematically provide prognostic information could address many cognitive biases, including status quo bias and optimism bias,14 15 that make clinicians less apt to identify patients who may benefit from palliative care. Indeed, such models have been shown to improve the frequency of palliative care delivery and patient outcomes in the hospital and clinic settings.9 16 17 With that said, successful implementation of automated prognostic models into routine clinical care at scale requires clinician and patient engagement and support.In this issue of BMJ Quality &.

Safety, Saunders and colleagues report on the acceptability of using the EMR-based Modified Hospitalised-Patient One-Year Mortality Risk (mHOMR) score to alert clinicians to individual patients with a >21% risk of dying within 12 months. The goal of the clinician notification of an elevated risk score was to prompt clinicians to consider palliative care referral.18 In a previously reported feasibility study among 400 hospitalised patients, use of the mHOMR alert was associated with increased rates of goals of care discussions and palliative care consultation in comparison to the preimplementation baseline (34% vs 18%, respectively).19 In the present study, the authors conducted qualitative interviews pre-mHOMR and post-mHOMR implementation among 64 stakeholders, including patients identified at high risk by the mHOMR algorithm, their caregivers, staff and physicians. Thirty-five (55%) participants agreed that the mHOMR tool was acceptable. 14 (22%) were unsure or did not agree. And 15 (23%) did not respond.

Participants identified many potential benefits of the programme, citing the advantages of an automated approach to facilitate and justify clinical decision making. Participants also acknowledged possible barriers, particularly ‘situational challenges’ such as the content, timing and mechanism of provider notification. Additional logistical concerns included alert fatigue, potential redundancy, uncertainty regarding next steps and a worry that certain therapeutic options could be withheld from flagged patients. The authors concluded that clinicians and patients found the automated prognostic trigger to be an acceptable addition to usual clinical care.Saunders et al’s work adds to our understanding of critical perceptions regarding end users’ acceptability of automated prognostic triggers in routine clinical care. The findings from this study align with prior evidence suggesting that clinicians recognise the value of automated, algorithm-based approaches to improve serious illness care.

For example, in a qualitative study of clinicians by Hallen et al, prognostic models confirmed clinicians’ gestalt and served as a tool to help communicate prognosis to patients.20 Clinicians described prognostic models as a tool to facilitate interclinician disagreements, mitigate medicolegal risk, and overcome the tendency to ignore or overestimate prognosis.20 Clinicians also reported that EMR-generated lists of high-risk patients improved their ability to identify potential palliative care beneficiaries in a mixed-methods study by Mason et al.21 In a single-centre pilot study, we similarly found that most clinicians believed that using an EMR-based prognostic model to encourage inpatient palliative care consultation was acceptable.9 However, in the Saunders et al study, as in prior similar work, clinicians highlighted the importance of delivering notifications without causing excess provider workload, redundancy or alert fatigue.16 18 21 Clinicians also raised concerns regarding the accuracy of the prognostic information and the potential for negative effects on patients due to common misperceptions about palliative care being equivalent to hospice.18 20 21 Ultimately, Saunders et al’s work complements and builds on existing literature, demonstrating a general perception that integration of automated prognostic models into routine clinical care could be beneficial and acceptable.Important gaps remain in this literature which were not addressed by the Saunders et al study. For example, there is a need to capture more diverse clinician and patient perspectives, and there was no information provided about the sociodemographic or clinical characteristics of the study participants. Additionally, important themes found in prior studies were not identified in this study. For example, two prior studies of clinicians’ perspectives on automated prognostic triggers for palliative care revealed concerns that prognosis alone may not be a sufficient surrogate indicator of actual palliative care need, or may inadvertently engender clinician overconfidence in an individual patient’s prognosis.9 21 The brevity of the interviews in Saunders et al’s study (mean. 12 min) could suggest all relevant themes may not have emerged in the data analysis.

Additionally, while the inclusion of patient and caregiver perceptions is an important addition, limited information is provided about their perspectives and whether certain themes differed among the stakeholders. In the study from Mason et al, themes unique to patients and caregivers were identified, such as hesitancy due to a lack of understanding of palliative care, a preference to ‘focus on the present’, and a worry that a clinician would not have the time to adequately address advanced care planning or palliative care during their visit.21 Healthcare systems should therefore be prepared to consider their unique workflows, patients and staff prior to implementing one of these programmes.Achieving stakeholder acceptability prior to widespread implementation is essential. An intervention should ideally undergo multiple cycles of optimisation with ongoing appraisal of patient and clinician perspectives prior to wide-scale implementation.22 23 Additionally, it is unclear whether clinicians’ acceptability of the intervention in one setting will generalise to other inpatient health settings. For instance, Saunders et al found that some providers were leery about the use of mHOMR due the need to balance the patient’s acute needs that brought them to the hospital with their long-term priorities that may be better served in the outpatient setting.18 Clinical workflows, patient acuity and patient–provider relationships are markedly different between the inpatient and outpatient settings, suggesting Saunders et al’s findings cannot be extrapolated to outpatient care. This is particularly relevant as many ‘off-the-shelf’ prognostic algorithms are now commercially available that, while accurate, may not be as familiar or acceptable to clinicians as a homegrown model.

Therefore, while Saunders et al’s work is a great addition to the field, additional assessments are needed across different healthcare environments and varying clinical and demographic cohorts to demonstrate that this approach is acceptable in other health settings. It is likely that multiple implementation strategies will be needed to successfully adapt automated prognostic models across a range of clinical settings.Thoughtful consideration of the many forces that alter clinical decision making will also be critical for downstream success of these interventions. Suboptimal clinical decision making is often a result of systemic biases, such as status quo and optimism bias, which result in clinician resistance to change current practice and a belief that their patients are less prone to negative outcomes.14 15 Intentional application of targeted behavioural economics principles will help ensure that the use of prognostic triggers to improve palliative care effectively changes clinical behaviour.24 For example, using an ‘opt-out’ approach for palliative care referral may make the optimal choice the path of least resistance, increasing uptake among clinicians.16 These approaches will need to be balanced against rising clinician alert fatigue25 and resource constraints.Given the implementation challenges that accompany an intervention using prognostic triggers, hybrid effectiveness trials that test both clinical effectiveness and implementation outcomes offer one strategy to advance the integration of automated prognostic models.26 Implementation outcomes are typically based on a framework which provides a systematic way to develop, manage and evaluate interventions. For example, Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) is a framework that measures the impact of a programme based on five factors. Reach, effectiveness, adoption, implementation and maintenance.27 Due to their pragmatic approach, hybrid trials frequently include heterogenous samples and clinical settings that optimise external validity and generalisability.26 28 They can be designed to primarily test the effects of a clinical interventions while observing and gathering information on implementation outcomes (type I), for equal evaluation of both the clinical intervention and implementation strategies (type II), or to primarily assess implementation outcomes while collecting effectiveness data (type III).26 29 For example, Beidas et al used a type I hybrid effectiveness–implementation trial design to test the effectiveness of an exercise intervention for breast cancer.

This study not only evaluated the effectiveness of the intervention but also identified multiple significant implementation barriers such as cost, referral logistics and patient selection challenges which informed their subsequent dissemination efforts.30 Prospective, randomised, hybrid effectiveness–implementation designs focusing on other key implementation outcomes are a logical and necessary next step in advancing the field. In total, the work by Saunders et al demonstrates the potential acceptability of an automated prognostic model to improve the timeliness of palliative care, setting the stage for further work to optimise and implement these programmes into real-world clinical care.Ethics statementsPatient consent for publicationNot required..

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Dewsnap C, Sauer see here U, Evans zithromax 500mg uses C. Sex Transm Infect 2020;96:79. Doi. 10.1136/sextrans-2019-054397This article was previously published with missing information.

Please note the below:The authors would like to acknowledge their gratitude to Daniel Richardson, Zara Haider, Ceri Evans, Janet Michaelis and Elizabeth Foley for providing a helpful format for this piece.Richardson D, Haider Z, Evans C, et al. The joint BASHH-FSRH conference. Sex Transm Infect 2017;93:380. Doi.

10.1136/sextrans-2017-053184Using cytokine expression to distinguish between active and treated syphilis. Promising but not yet ready for prime timeDistinguishing between previously treated and active syphilis can be challenging in the subset of treated patients with serofast status, defined as persistent non-treponemal seropositivity (<4-fold decline in rapid plasma reagin titre ≥6 months after treatment). The study investigated whether serum cytokine expression levels, measured with a 62-cytokine multiplex bead-based ELISA, can help guide clinical management. Using samples from patients with active, treated and serofast syphilis, the authors developed a two-cytokine (brain-derived neurotrophic factor and tumour necrosis factor β) decision tree that showed good accuracy (82%) and sensitivity (100%) but moderate specificity (45%).

While further studies will be needed to confirm and refine the diagnostic algorithm, there also remain important technical, operational and financial barriers to implementing such cytokine assays in routine care.Kojima N, Siebert JC, Maecker H, et al. The application of cytokine expression assays to differentiate active from previously treated syphilis. J Infect Dis. 2020 [published online ahead of print, 2020 Mar 19].Global and regional prevalence of herpes simplex zithromax type 2 .

Updated estimates for people aged 15–49 yearsEstimates of genital herpes simplex zithromax (HSV) s across regions inform advocacy and resource planning and guide the development of improved control measures, including treatments. In 2016, HSV-2 affected 13% of the global population aged 15–49 years (high-risk groups excluded), totalling 491 million people. Of note, by excluding people aged >49 years, the analysis knowingly underestimated the true burden of HSV-2 .1 Prevalence showed a slight increase relative to 2012 and was highest in Africa and Americas and among women. Given the association between HSV-2 and subsequent HIV ,2 it is concerning that HSV-2 was estimated to affect ~50% of women aged 25–34 years in the African region.

The analysis also estimated the prevalence of genital HSV-1 (3%), but uncertainty intervals were wide.James C, Harfouche M, Welton NJ, et al. Herpes simplex zithromax. Global prevalence and incidence estimates, 2016. Bull World Health Organ.

2020. 98. 315-329.Observed pregnancy and neonatal outcomes in women with HIV exposed to recommended antiretroviral regimensThis large Italian observational cohort study analysed data from 794 pregnant women who were exposed within 32 weeks of gestation to recommended antiretroviral regimens in the period 2008–2018. Treatment comprised three-drug combinations of an nucleoside reverse transcriptase inhibitor (NRTI) backbone plus a ritonavir-boosted protease inhibitor (78%, predominantly atazanavir), an non-NRTI (NNRTI) (15%, predominantly nevirapine) or an integrase strand transfer inhibitor (INSTI.

6%, predominantly raltegravir). No major differences were found for a wide range of pregnancy and neonatal outcomes, including major congenital defects. The rate of HIV zithromax purchase transmission ranged up to 2.4% in this study. This comprehensive evaluation will be useful for clinicians caring for women with HIV.

More outcome data are needed for regimens comprising second-generation INSTIs.Floridia M, Dalzero S, Giacomet V, et al. Pregnancy and neonatal outcomes in women with HIV-1 exposed to integrase inhibitors, protease inhibitors and non-nucleoside reverse transcriptase inhibitors. An observational study. 2020;48:249–258.HIV status and sexual practice independently correlate with gut dysbiosis and unique microbiota signaturesGut dysbiosis may contribute to persistent inflammation in people with HIV (PWH) who receive antiretroviral therapy (ART).

The study compared the gut microbiota of ART-treated PWH and HIV-negative controls matched for age, gender, country of birth, body mass index and sexual practice. Regardless of sex and sexual practice, the gut microbiota differed significantly in PWH vrsus controls, with expansion of proinflammatory gut bacteria and depletion of homeostasis-promoting microbiota members. The extent of dysbiosis correlated with serum inflammatory markers, nadir and pre-ART CD4 cell counts, and prevalence of non-infectious comorbidities. Further studies are warranted to elucidate causality and investigate microbiota-mediated strategies to alleviate HIV-associated inflammation.

Independent of HIV status, and in both men and women, receptive anal intercourse was associated with a unique microbiota signature.Vujkovic-Cvijin I, Sortino O, Verheij E, et al. HIV-associated gut dysbiosis is independent of sexual practice and correlates with non-communicable diseases. Nat Commun. 2020;11:2448.Reducing the cost of molecular STI screening in resource-limited settings.

An optimised sample-pooling algorithms with Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are frequently asymptomatic and, if untreated, may lead to severe reproductive complications in women. Molecular testing is highly sensitive but costly, especially for resource-limited settings. This modelling study explored a sample pooling strategy for CT and NG testing among women in Zambia. Based on cross-sectional data, participants were stratified into high, intermediate and low prevalence groups, and the respective specimens were mathematically modelled to be tested individually, in pools of 3, or pools of 4, using the GeneXpert instrument.

Overall, the pooling strategy was found to maintain acceptable sensitivity (ranging from 80% to 100%), while significantly lowering cost per sample. Investigation in additional cohorts will validate whether the approach may increase access to STI screening where resourced are constrained.Connolly S, Kilembe W, Inambao M, et al. A population-specific optimized GeneXpert pooling algorithm for Chlamydia trachomatis and Neisseria gonorrhoeae to reduce cost of molecular STI screening in resource-limited settings. J Clin Microbiol.

2020 [published online ahead of print, 2020 Jun 10].Girl-only HPV vaccination can eliminate cervical cancer in most low and lower middle income countries by the end of the century, but must be supplemented by screening in high incidence countriesProgress towards the global elimination of cervical cancer must include effective interventions in lower-middle income countries (LMICs). The study modelled the effect over the next century of girls-only human papilloma zithromax (HPV) vaccination with or without once-lifetime or twice-lifetime cervical screening in 78 LMICs, assuming 90% treatment coverage, 100% lifetime protection and screening uptake increasing from 45% (2023) to 90% (2045 onwards). Vaccination alone would substantially reduce cancer incidence (61 million cases averted) and achieve elimination (<5 cases per 100 000 women-years) in 60% of LMICs. However, high-incidence countries, predominantly in Africa, might not reach elimination by vaccination alone.

Adding twice-lifetime screening would achieve elimination of cervical cancer in 100% of LMICs. Results have informed the targets of 90% HPV vaccination coverage, 70% screening coverage and 90% of cervical lesions treated by 2030 recently announced by the WHO.Brisson M, Kim JJ, Canfell K, et al. Impact of HPV vaccination and cervical screening on cervical cancer elimination. A comparative modelling analysis in 78 low-income and lower-middle-income countries.

Dewsnap C, Sauer zithromax 500mg for sale you can look here U, Evans C. Sex Transm Infect 2020;96:79. Doi.

10.1136/sextrans-2019-054397This article was previously published with missing information. Please note the below:The authors would like to acknowledge their gratitude to Daniel Richardson, Zara Haider, Ceri Evans, Janet Michaelis and Elizabeth Foley for providing a helpful format for this piece.Richardson D, Haider Z, Evans C, et al. The joint BASHH-FSRH conference.

Sex Transm Infect 2017;93:380. Doi. 10.1136/sextrans-2017-053184Using cytokine expression to distinguish between active and treated syphilis.

Promising but not yet ready for prime timeDistinguishing between previously treated and active syphilis can be challenging in the subset of treated patients with serofast status, defined as persistent non-treponemal seropositivity (<4-fold decline in rapid plasma reagin titre ≥6 months after treatment). The study investigated whether serum cytokine expression levels, measured with a 62-cytokine multiplex bead-based ELISA, can help guide clinical management. Using samples from patients with active, treated and serofast syphilis, the authors developed a two-cytokine (brain-derived neurotrophic factor and tumour necrosis factor β) decision tree that showed good accuracy (82%) and sensitivity (100%) but moderate specificity (45%).

While further studies will be needed to confirm and refine the diagnostic algorithm, there also remain important technical, operational and financial barriers to implementing such cytokine assays in routine care.Kojima N, Siebert JC, Maecker H, et al. The application of cytokine expression assays to differentiate active from previously treated syphilis. J Infect Dis.

2020 [published online ahead of print, 2020 Mar 19].Global and regional prevalence of herpes simplex zithromax type 2 . Updated estimates for people aged 15–49 yearsEstimates of genital herpes simplex zithromax (HSV) s across regions inform advocacy and resource planning and guide the development of improved control measures, including treatments. In 2016, HSV-2 affected 13% of the global population aged 15–49 years (high-risk groups excluded), totalling 491 million people.

Of note, by excluding people aged >49 years, the analysis knowingly underestimated the true burden of HSV-2 .1 Prevalence showed a slight increase relative to 2012 and was highest in Africa and Americas and among women. Given the association between HSV-2 and subsequent HIV ,2 it is concerning that HSV-2 was estimated to affect ~50% of women aged 25–34 years in the African region. The analysis also estimated the prevalence of genital HSV-1 (3%), but uncertainty intervals were wide.James C, Harfouche M, Welton NJ, et al.

Herpes simplex zithromax. Global prevalence and incidence estimates, 2016. Bull World Health Organ.

2020. 98. 315-329.Observed pregnancy and neonatal outcomes in women with HIV exposed to recommended antiretroviral regimensThis large Italian observational cohort study analysed data from 794 pregnant women who were exposed within 32 weeks of gestation to recommended antiretroviral regimens in the period 2008–2018.

Treatment comprised three-drug combinations of an nucleoside reverse transcriptase inhibitor (NRTI) backbone plus a ritonavir-boosted protease inhibitor (78%, predominantly atazanavir), an non-NRTI (NNRTI) (15%, predominantly nevirapine) or an integrase strand transfer inhibitor (INSTI. 6%, predominantly raltegravir). No major differences were found for a wide range of pregnancy and neonatal outcomes, including major congenital defects.

The rate of HIV transmission ranged up to 2.4% in this study. This comprehensive evaluation will be useful for clinicians caring for women with HIV. More outcome data are needed for regimens comprising second-generation INSTIs.Floridia M, Dalzero S, Giacomet V, et al.

Pregnancy and neonatal outcomes in women with HIV-1 exposed to integrase inhibitors, protease inhibitors and non-nucleoside reverse transcriptase inhibitors. An observational study. 2020;48:249–258.HIV status and sexual practice independently correlate with gut dysbiosis and unique microbiota signaturesGut dysbiosis may contribute to persistent inflammation in people with HIV (PWH) who receive antiretroviral therapy (ART).

The study compared the gut microbiota of ART-treated PWH and HIV-negative controls matched for age, gender, country of birth, body mass index and sexual practice. Regardless of sex and sexual practice, the gut microbiota differed significantly in PWH vrsus controls, with expansion of proinflammatory gut bacteria and depletion of homeostasis-promoting microbiota members. The extent of dysbiosis correlated with serum inflammatory markers, nadir and pre-ART CD4 cell counts, and prevalence of non-infectious comorbidities.

Further studies are warranted to elucidate causality and investigate microbiota-mediated strategies to alleviate HIV-associated inflammation. Independent of HIV status, and in both men and women, receptive anal intercourse was associated with a unique microbiota signature.Vujkovic-Cvijin I, Sortino O, Verheij E, et al. HIV-associated gut dysbiosis is independent of sexual practice and correlates with non-communicable diseases.

Nat Commun. 2020;11:2448.Reducing the cost of molecular STI screening in resource-limited settings. An optimised sample-pooling algorithms with Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are frequently asymptomatic and, if untreated, may lead to severe reproductive complications in women.

Molecular testing is highly sensitive but costly, especially for resource-limited settings. This modelling study explored a sample pooling strategy for CT and NG testing among women in Zambia. Based on cross-sectional data, participants were stratified into high, intermediate and low prevalence groups, and the respective specimens were mathematically modelled to be tested individually, in pools of 3, or pools of 4, using the GeneXpert instrument.

Overall, the pooling strategy was found to maintain acceptable sensitivity (ranging from 80% to 100%), while significantly lowering cost per sample. Investigation in additional cohorts will validate whether the approach may increase access to STI screening where resourced are constrained.Connolly S, Kilembe W, Inambao M, et al. A population-specific optimized GeneXpert pooling algorithm for Chlamydia trachomatis and Neisseria gonorrhoeae to reduce cost of molecular STI screening in resource-limited settings.

J Clin Microbiol. 2020 [published online ahead of print, 2020 Jun 10].Girl-only HPV vaccination can eliminate cervical cancer in most low and lower middle income countries by the end of the century, but must be supplemented by screening in high incidence countriesProgress towards the global elimination of cervical cancer must include effective interventions in lower-middle income countries (LMICs). The study modelled the effect over the next century of girls-only human papilloma zithromax (HPV) vaccination with or without once-lifetime or twice-lifetime cervical screening in 78 LMICs, assuming 90% treatment coverage, 100% lifetime protection and screening uptake increasing from 45% (2023) to 90% (2045 onwards).

Vaccination alone would substantially reduce cancer incidence (61 million cases averted) and achieve elimination (<5 cases per 100 000 women-years) in 60% of LMICs. However, high-incidence countries, predominantly in Africa, might not reach elimination by vaccination alone. Adding twice-lifetime screening would achieve elimination of cervical cancer in 100% of LMICs.

Results have informed the targets of 90% HPV vaccination coverage, 70% screening coverage and 90% of cervical lesions treated by 2030 recently announced by the WHO.Brisson M, Kim JJ, Canfell K, et al. Impact of HPV vaccination and cervical screening on cervical cancer elimination. A comparative modelling analysis in 78 low-income and lower-middle-income countries.