Effect of CMV Mismatch on Heart Transplant Outcomes Using a Surveillance and Preemptive Strategy.

PURPOSE: The aim of the study was to determine outcomes after heart transplantation for cytomegalovirus (CMV) mismatched patients (D+/R-) who underwent a surveillance and preemptive therapy protocol, compared to nonmismatch patients. METHODS: A review of patient records from January 2010 to December 2020 with follow-up to October 2023 was done. The protocol consisted weekly surveillance with CMV PCR starting 4 weeks after transplant continuing up until the patient seroconverts or up to 3 months posttransplant if the patient does not seroconvert. Valganciclovir was given for 2 weeks to those who seroconverted. RESULTS: Two hundred and twenty-one patients were included, and 23% were mismatched patients. Overall survival was not different between CMV groups (p = NS). Causes of death and morbidities were also not significantly different (p = NS). Sixty-six percent of mismatch patients seroconverted, and there was also a significantly older donor age in the seroconverted patients compared to nonseroconverted patients (41 ± 11 vs. 29 ± 12 years, p < 0.005), indicating a higher risk donor profile. A multivariate Cox regression including donor age showed that there was no increase in mortality in the seroconverted mismatches compared to nonmismatch patients (p = NS). CONCLUSIONS: There is no significant increased mortality or morbidity using a CMV surveillance and preemptive therapy protocol. The effect of donor age on seroconversion of mismatches requires further validation.

Trends in Pediatric Head and Facial Trauma During the COVID-19 Pandemic.

INTRODUCTION: The effect of physical-distancing policies and school closures on pediatric health has been a topic of major concern in the United States during the coronavirus disease 2019 (COVID-19) pandemic. The objective of this study was to assess the immediate impact of these public policies on patterns of head and facial trauma in the pediatric population. MATERIALS AND METHOD: The Pediatric Health Information System (PHIS) was queried to identify patient encounters at 46 children's hospitals across the United States in 2016-2020. Encounters were included if resultant in ICD-10 diagnosis for head or facial trauma in a child under 18 between April 1 and June 30 in 2020 (first COVID-19 school closures) and during the same period in the previous 4 years (for comparison). RESULTS: A total of 170,832 patient encounters for pediatric head and facial trauma were recorded during the study period, including 28,030 (16.4%) in 2020 and 142,802 (83.6%) in 2016-2019. Patient encounters declined significantly in 2020 among children of all age groups relative to previous years. Relative reductions were greatest in children aged 11 to 17 (middle/high school) and 6 to 10 (elementary school), at -34.6% (95% confidence interval: -23.6%, -44%; P <0.001) and -27.7% (95% confidence interval: -18.4%, -36%; P <0.001). Variation in relative reductions by race/ethnicity, sex, and rural/urban status were not statistically significant. CONCLUSIONS: Physical-distancing policies and school closures at the start of the COVID-19 pandemic correlated with significant reductions in pediatric head and facial trauma patient encounters. As in-person activities resume, reductions in head and facial trauma during the pandemic may indicate a range of possible preventable injuries in the future.

Do patients treated with Invisalign have less swelling after orthognathic surgery than those with fixed orthodontic appliances?

INTRODUCTION: Patients treated with perioperative Invisalign for orthognathic surgery may experience less postoperative swelling than those with fixed appliances because of a lack of mucosal irritation from bonded brackets and wires. The aims of this study were to (1) compare facial swelling after orthognathic surgery in subjects with Invisalign to those with fixed appliances using 3-dimensional (3D) subtraction imaging and (2) determine if the type of operation influences differences in swelling. METHODS: This is a retrospective case-control study. To be included in the case group (Invisalign), patients had to have had: (1) LeFort I and/or bilateral sagittal split osteotomies, with or without genioplasty, (2) perioperative orthodontic treatment using Invisalign, and (3) 3D photographs at postoperative timepoints 1 week (T1), 3-4 weeks (T2), and 5-7 weeks. A sex and operation-matched control group with fixed appliances (standard) was also included. The primary outcome variable was the volume of facial swelling, measured by subtraction imposition of the T1 and T2 3D images using reference images (5-7 weeks). RESULTS: Twenty-two subjects (36% female; mean age 20.7 ± 3.15 years) were included: Invisalign (n = 11) and standard (n = 11). For each group, 7 subjects had 1 operation (LeFort I or bilateral sagittal split osteotomies), and 4 had bimaxillary surgery ± genioplasty. At T1, the Invisalign group had significantly less swelling than the standard group (17.52 ± 10.79 cm3 vs 37.53 ± 14.62 cm3; P <0.001). By T2, the differences were no longer significant (6.62 ± 5.19 cm3 for Invisalign; 5.85 ± 4.39 cm3 for standard, P = 0.728). CONCLUSION: Subjects with Invisalign had significantly less facial swelling in the first postoperative week than those with fixed appliances.

Gender differences in the assessment, decision-making and outcomes for ventricular assist devices and heart transplantation: An analysis from a UK transplant center.

PURPOSE: There are marked gender differences in all etiologies of advanced heart failure. We sought to determine whether there is evidence of gender-specific decision making for transplant assessments, and how gender effects outcomes. METHODS: Retrospective analysis of adult heart transplant assessments at a single UK center between April 2015 and March 2020. RESULTS: Females were 32% of referrals (N = 137 females, 285 males), with marked differences between diagnoses - 11% ischemic and 43% of adult congenital. Females were younger, shorter, weighed less, and had lower pulmonary pressures. Females were much less likely to receive a ventricular assist device (13%). Blood type "O" females were relatively more likely compared to males to receive a transplant (45%). Comparing males and females who received a ventricular assist device, both had similar levels of high pulmonary pressures, indicating consistent decision-making based on hemodynamics to implant a device. Overall survival was better for females (in noncongenital patients), and this was due to female patients who were not accepted for transplant or a ventricular assist device being more often "too well for transplant," rather than in males when they were more often "unsuitable." CONCLUSIONS: Marked gender differences exist at all stages of the heart transplant assessment pathway. Appropriate decision-making based on clinical grounds is shown with less transplants in male blood type "O"s and hemodynamic criteria for ventricular assist device implantation in both genders. Further studies are needed to determine if there is a wider community bias in advanced heart failure treatments for females.

Heart transplantation in children and adults with Down syndrome: A single centre experience.

BACKGROUND: In recent years, rapid advances in cardiac surgery and changes in attitude towards patients with cognitive disability have led to these patients receiving cardiac transplantation. METHOD: This is a retrospective report describing the experience of four patients with Down Syndrome who received heart transplantation in a single institution. RESULTS: Anthracycline-induced cardiomyopathy was the most common cause of heart failure in this group (3/4). Two patients were bridged to transplantation, one by using a combination of extra-corporeal membrane oxygenation and biventricular assist device and the other by using a durable implantable left ventricular assist device. All the four patients are alive with the longest surviving patient 17 years after transplantation. Against strong hypothetical predictions, we observed no propensity for the development of post-transplant infections or lymphoproliferative disorders. CONCLUSION: Down Syndrome should not be the sole contraindication to heart transplantation. The decision for transplantation should be on a case-by-case basis provided adequate social support is in place.

Does infection predispose to thrombosis during long-term ventricular assist device support?

BACKGROUND: Infections and thrombotic events remain life-threatening complications in patients with ventricular assist devices (VAD). METHODS: We describe the relationship between both events in our cohort of patients (n = 220) supported with the HeartWare VAD (HVAD). This is a retrospective analysis of patients undergoing HVAD implantation between July 2009 and March 2019 at the Freeman Hospital, Newcastle upon Tyne, United Kingdom. RESULTS: Infection was the most common adverse event in HVAD patients, with 125 patients (56.8%) experiencing ≥ one infection (n = 168, 0.33 event per person year (EPPY)), followed by pump thrombosis (PT) in 61 patients (27.7%, 0.16 EPPY). VAD-specific infections were the largest group of infections. Of the 125 patients who had an infection, 66 (53%) had a thrombotic event. Both thrombotic events and infections were related to the duration of support, though there was only limited evidence that infections predispose to thrombosis. Those with higher than median levels of C-reactive protein during the infection were more likely to have an ischaemic stroke (IS) (34.5% vs 16.7%, p = .03), though not PT or a combined thrombotic event (CTE: first PT or IS). However, in multivariate analysis, there was no significant effect of infection predisposing to CTE. CONCLUSIONS: Infection and thrombotic events are significant adverse events related to the duration of support in patients receiving HVADs. Infections do not clearly predispose to thrombotic events.

Validity of Hemodynamic Monitoring Using Inert Gas Rebreathing Method in Patients With Chronic Heart Failure and Those Implanted With a Left Ventricular Assist Device.

OBJECTIVE: The present study assessed agreement between resting cardiac output estimated by inert gas rebreathing (IGR) and thermodilution methods in patients with heart failure and those implanted with a left ventricular assist device (LVAD). METHODS AND RESULTS: Hemodynamic measurements were obtained in 42 patients, 22 with chronic heart failure and 20 with implanted continuous flow LVAD (34 males, aged 50 ± 11 years). Measurements were performed at rest using thermodilution and IGR methods. Cardiac output derived by thermodilution and IGR were not significantly different in LVAD (4.4 ± 0.9 L/min vs 4.7 ± 0.8 L/min, P = .27) or patients with heart failure (4.4 ± 1.4 L/min vs 4.5 ± 1.3 L/min, P = .75). There was a strong relationship between thermodilution and IGR cardiac index (r = 0.81, P = .001) and stroke volume index (r = 0.75, P = .001). Bland-Altman analysis showed acceptable limits of agreement for cardiac index derived by thermodilution and IGR, namely, the mean difference (lower and upper limits of agreement) for patients with heart failure -0.002 L/min/m2 (-0.65 to 0.66 L/min/m2), and -0.14 L/min/m2 (-0.78 to 0.49 L/min/m2) for patients with LVAD. CONCLUSIONS: IGR is a valid method for estimating cardiac output and should be used in clinical practice to complement the evaluation and management of chronic heart failure and patients with an LVAD.

A retrospective evaluation of catheter ablation in atrial flutter post cardiac transplantation.

BACKGROUND: Atrial flutter is the most common arrhythmia post cardiac transplantation. Observational studies in the non-transplant population have shown prognostic benefit with catheter ablation; however, there are no data in the heart transplant population. OBJECTIVES: This study evaluated the experience of catheter ablation in atrial flutter post cardiac transplantation. METHODS: A retrospective review of experience of late onset atrial flutter at the Freeman Hospital, Newcastle-upon-Tyne, UK, between 1985 and January 2020. RESULTS: Sixty eight of the 722 patients who survived 6 months post cardiac transplantation developed late atrial flutter giving an incidence of 9.4%. Thirty-two patients were managed with ablation with treatment largely determined by time of flutter onset. Kaplan Meier estimates for arrhythmia free survival post first ablation for organized atrial arrhythmias was 83.3% at 1 year. Kaplan-Meier estimates for median survival post onset of atrial arrhythmias treated with ablation was 11.34 years (95% CI 8.00-14.57), compared to 5.79 years in patients managed medically (95%CI 2.26-9.32) (P = .026). CONCLUSIONS: Atrial flutter is an important late complication of cardiac transplantation. Patients treated with ablation in the modern era had increased survival compared to a historical cohort.

Using the WHO safe childbirth checklist to improve essential care delivery as part of the district-wide maternal and newborn health quality improvement initiative, a time series study.

BACKGROUND: Care bundles are a set of three to five evidence-informed practices which, when performed collectively and reliably, may improve health system performance and patient care. To date, many studies conducted to improve the quality of essential birth care practices (EBPs) have focused primarily on provider- level and have fallen short of the predicted impact on care quality, indicating that a systems approach is needed to improve the delivery of reliable quality care. This study evaluates the effect of integrating the use of the World Health Organization Safe Childbirth Checklist (WHO-SCC) into a district-wide system improvement collaborative program designed to improve and sustain the delivery of EBPs as measured by "clinical bundle" adherence over-time. METHODS: The WHO-SCC was introduced in the context of a district-wide Maternal and Newborn Health (MNH) collaborative quality of care improvement program in four agrarian Ethiopia regions. Three "clinical bundles" were created from the WHO-SCC: On Admission, Before Pushing, and Soon After Birth bundles. The outcome of each bundle was measured using all- or- none adherence. Adherence was assessed monthly by reviewing charts of live births. A time-series analysis was employed to assess the effectiveness of system-level interventions on clinical bundle adherence. STATA version 13.1 was used to analyze the trend of each bundle adherence overtime. Autocorrelation was checked to assess if the assumption of independence in observations collected overtime was valid. Prais-Winsten was used to minimize the effect of autocorrelation. FINDINGS: Quality improvement interventions targeting the three clinical bundles resulted in improved adherence over time across the four MNH collaborative. In Tankua Abergele collaborative (Tigray Region), the overall mean adherence to "On Admission" bundle was 86% with ß = 1.39 (95% CI; 0.47-2.32; P <  0.005) on average monthly. Similarly, the overall mean adherence to the "Before Pushing" bundle in Dugna Fango collaborative; Southern Nations, Nationalities and People's (SNNP) region was 80% with ß = 2.3 (95% CI; 0.89-3.74; P <  0.005) on average monthly. CONCLUSION: Using WHO-SCC paired with a system-wide quality improvement approach improved and sustained quality of EBPs delivery. Further studies should be conducted to evaluate the impact on patient-level outcomes.

A hybrid Shewhart chart for visualizing and learning from epidemic data.

OBJECTIVE: As the globe endures the coronavirus disease 2019 (COVID-19) pandemic, we developed a hybrid Shewhart chart to visualize and learn from day-to-day variation in a variety of epidemic measures over time. CONTEXT: Countries and localities have reported daily data representing the progression of COVID-19 conditions and measures, with trajectories mapping along the classic epidemiological curve. Settings have experienced different patterns over time within the epidemic: pre-exponential growth, exponential growth, plateau or descent and/ or low counts after descent. Decision-makers need a reliable method for rapidly detecting transitions in epidemic measures, informing curtailment strategies and learning from actions taken. METHODS: We designed a hybrid Shewhart chart describing four 'epochs' ((i) pre-exponential growth, (ii) exponential growth, (iii) plateau or descent and (iv) stability after descent) of the COVID-19 epidemic that emerged by incorporating a C-chart and I-chart with a log-regression slope. We developed and tested the hybrid chart using international data at the country, regional and local levels with measures including cases, hospitalizations and deaths with guidance from local subject-matter experts. RESULTS: The hybrid chart effectively and rapidly signaled the occurrence of each of the four epochs. In the UK, a signal that COVID-19 deaths moved into exponential growth occurred on 17 September, 44 days prior to the announcement of a large-scale lockdown. In California, USA, signals detecting increases in COVID-19 cases at the county level were detected in December 2020 prior to statewide stay-at-home orders, with declines detected in the weeks following. In Ireland, in December 2020, the hybrid chart detected increases in COVID-19 cases, followed by hospitalizations, intensive care unit admissions and deaths. Following national restrictions in late December, a similar sequence of reductions in the measures was detected in January and February 2021. CONCLUSIONS: The Shewhart hybrid chart is a valuable tool for rapidly generating learning from data in close to real time. When used by subject-matter experts, the chart can guide actionable policy and local decision-making earlier than when action is likely to be taken without it.

Understanding variation in reported covid-19 deaths with a novel Shewhart chart application.

OBJECTIVE: Motivated by the coronavirus disease 2019 (covid-19) pandemic, we developed a novel Shewhart chart to visualize and learn from variation in reported deaths in an epidemic. CONTEXT: Without a method to understand if a day-to-day variation in outcomes may be attributed to meaningful signals of change-rather than variability we would expect-care providers, improvement leaders, policy-makers, and the public will struggle to recognize if epidemic conditions are improving. METHODS: We developed a novel hybrid C-chart and I-chart to detect within a geographic area the start and end of exponential growth in reported deaths. Reported deaths were the unit of analysis owing to erratic reporting of cases from variability in local testing strategies. We used simulation and case studies to assess chart performance and define technical parameters. This approach also applies to other critical measures related to a pandemic when high-quality data are available. CONCLUSIONS: The hybrid chart detected the start of exponential growth and identified early signals that the growth phase was ending. During a pandemic, timely reliable signals that an epidemic is waxing or waning may have mortal implications. This novel chart offers a practical tool, accessible to system leaders and frontline teams, to visualize and learn from daily reported deaths during an epidemic. Without Shewhart charts and, more broadly, a theory of variation in our epidemiological arsenal, we lack a scientific method for a real-time assessment of local conditions. Shewhart charts should become a standard method for learning from data in the context of a pandemic or epidemic.

Assessing Knowledge and Promoting Awareness of Chronic Recurrent Multifocal Osteomyelitis Among Oral and Maxillofacial Surgeons.

PURPOSE: Chronic recurrent multifocal osteomyelitis (CRMO) is underdiagnosed and underreported because of a lack of awareness among providers. While patients with undiagnosed CRMO often present to oral and maxillofacial surgeons (OMSs) with a chief complaint of mandibular pain, to our knowledge, there is no literature regarding how well informed these providers are about this disease. Survey studies and educational efforts have been carried out among other specialists with the aim of raising awareness. The purpose of this study was to document current levels of understanding and determine knowledge gaps among OMSs regarding the diagnostic process for CRMO. MATERIALS AND METHODS: For this cross-sectional cohort study, the investigators sent an anonymous and electronic survey to OMSs practicing in the United States. Using a clinical vignette, the survey captured respondents' ability to evaluate, diagnosis, and take appropriate next steps for a hypothetical patient with CRMO. RESULTS: A total of 429 respondents completed the entire survey. The following proportion of respondents correctly answered questions pertaining to information gathering (10.3%), differential diagnosis (9.8%), overall diagnostic workup (76.7%), diagnostic imaging (78.8%), diagnostic laboratory tests (36.8%), biopsy and specimen (0.5%), and final diagnosis and next steps (9.6%). CONCLUSION: Our findings demonstrate incomplete understanding of this disorder among OMSs and uncover knowledge deficiencies that can lead to misdiagnosis and/or delay in appropriate treatment. To improve patient outcomes, it is paramount to augment educational initiatives among practitioners regarding this disease.

Rituximab in refractory chronic inflammatory demyelinating polyneuropathy.

INTRODUCTION: Chronic inflammatory demyelinating polyneuropathy (CIDP) is a disorder in which early effective treatment is important to minimize disability from axonal degeneration. It has been suggested that some patients with CIDP may benefit from rituximab therapy, but there is no definitive evidence for this. METHODS: Baseline and post-rituximab-therapy neuromuscular Medical Research Council (MRC) sum scores, Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, and functional status were assessed in 11 patients with refactory CIDP. RESULTS: The MRC sum score, INCAT disability score, and functional status improved in all patients after rituximab therapy. DISCUSSION: Our study provides evidence of the efficacy of rituximab therapy in at least some patients with CIDP. A placebo-controlled study to assess the effectiveness of rituximab therapy in CIDP with and without nodal antibodies is required to identify disease markers that predict responsiveness.

The impact of severe acute kidney injury requiring renal replacement therapy on survival and renal function of heart transplant recipients - a UK cohort study.

Severe acute kidney injury (AKI), defined as requiring renal replacement therapy (RRT), is associated with higher mortality postheart transplantation, but its long-term renal consequences are not known. Anonymized data of 3365 patients, who underwent heart transplantation between 1995 and 2017, were retrieved from the UK Transplant Registry. Multivariable binary logistic regression was performed to identify risk factors for severe AKI requiring RRT, Kaplan-Meier analysis to compare survival and renal function deterioration of the RRT and non-RRT groups, and multivariable Cox regression model to identify predicting factors of mortality and end-stage renal disease (ESRD). 26.0% of heart recipients received RRT post-transplant. The RRT group has lower survival rates at all time points, especially in the immediate post-transplant period. However, conditional on 3 months survival, older age, diabetes and coronary heart disease, but not post-transplant RRT, were the risk factors for long-term survival. The predicting factors for ESRD were insulin-dependent diabetes, renal function at transplantation, eGFR decline in the first 3 months post-transplant, post-transplant severe AKI and transplantation era. Severe AKI requiring RRT post-transplant is associated with worse short-term survival, but has no impact on long-term mortality. It also accelerates recipients' renal function deterioration in the long term.

Paediatric donation after circulatory determined death heart transplantation using donor normothermic regional perfusion and ex situ heart perfusion: A case report.

This is a report of a unique DCD paediatric heart transplant whereby normothermic regional perfusion was used to assess DCD heart function after death followed by ex situ heart perfusion of the graft during transportation from donor to recipient hospitals. The DCD donor was a 9-year-old boy weighing 84 kg. The recipient was 7-year-old boy with failing Fontan circulation and weighed 23 kg. It was an ABO-compatible heart transplantation. The DCD heart was reperfused and assessed using normothermic regional perfusion followed by portable ex situ heart perfusion during transportation. The orthotopic heart transplantation was successful with good graft function and no evidence of rejection on endomyocardial biopsy at 30 days post-transplant. At 1-year follow-up, excellent graft function is maintained, and he is attending school with a good quality of life. DCD heart transplantation in children is a promising solution to reducing paediatric waiting times. The case demonstrates the feasibility of using normothermic regional perfusion in the donor and ex situ heart perfusion during graft transportation. This combination allowed a functional assessment whilst minimizing warm ischaemia resulting in a successful outcome. More research and long-term follow-up are needed in order to benefit from the huge potential that paediatric DCD heart transplantation has to offer.

Classification of patient-safety incidents in primary care.

Primary care lags behind secondary care in the reporting of, and learning from, incidents that put patient safety at risk. In primary care, there is no universally agreed approach to classifying the severity of harm arising from such patient-safety incidents. This lack of an agreed approach limits learning that could lead to the prevention of injury to patients. In a review of research on patient safety in primary care, we identified 21 existing approaches to the classification of harm severity. Using the World Health Organization's (WHO's) International Classification for Patient Safety as a reference, we undertook a framework analysis of these approaches. We then developed a new system for the classification of harm severity. To assess and classify harm, most existing approaches use measures of symptom duration (11/21), symptom severity (11/21) and/or the level of intervention required to manage the harm (14/21). However, few of these approaches account for the deleterious effects of hospitalization or the psychological stress that may be experienced by patients and/or their relatives. The new classification system we developed builds on WHO's International Classification for Patient Safety and takes account not only of hospitalization and psychological stress but also of so-called near misses and uncertain outcomes. The constructs we have outlined have the potential to be applied internationally, across primary-care settings, to improve both the detection and prevention of incidents that cause the most severe harm to patients.

Les soins primaires ont du retard sur les soins secondaires en ce qui concerne l'établissement de rapports sur les incidents qui menacent la sécurité des patients et les enseignements qui en découlent. Dans le cas des soins primaires, il n'existe pas de méthode universellement acceptée pour classifier la gravité des dommages résultant d'incidents liés à la sécurité des patients. L'absence d'une telle méthode limite les enseignements qui pourraient favoriser la prévention des traumatismes chez les patients. Dans le cadre d'une analyse documentaire sur la sécurité des patients en matière de soins primaires, nous avons repéré l'existence de 21 méthodes de classification de la gravité des dommages. En prenant comme référence la Classification internationale pour la sécurité des patients de l'Organisation mondiale de la Santé (OMS), nous avons entrepris une analyse du cadre de ces méthodes. Nous avons ensuite conçu un nouveau système de classification de la gravité des dommages. Pour évaluer et classifier les dommages, la plupart des méthodes existantes utilisent des mesures portant sur la durée des symptômes (11/21), la gravité des symptômes (11/21) et/ou le niveau d'intervention requis pour prendre en charge les dommages (14/21). Néanmoins, rares sont celles qui tiennent compte des effets délétères de l'hospitalisation ou du stress psychologique que peuvent ressentir les patients et/ou leurs proches. Le nouveau système de classification que nous avons élaboré repose sur la Classification internationale pour la sécurité des patients de l'OMS et tient compte non seulement de l'hospitalisation et du stress psychologique, mais aussi de ce qu'il est convenu d'appeler les accidents évités de justesse et des résultats incertains. Les concepts que nous avons définis peuvent être appliqués dans les établissements de soins primaires du monde entier pour améliorer la détection et la prévention des incidents qui provoquent les plus graves dommages pour les patients.

La atención primaria queda por debajo de la atención secundaria en la notificación y el aprendizaje de incidentes que ponen en riesgo la seguridad del paciente. En la atención primaria, no existe un enfoque universalmente aceptado para clasificar la gravedad del daño que surge de tales incidentes que afectan a la seguridad del paciente. Esta falta de un enfoque consensuado limita el aprendizaje que podría conducir a la prevención de lesiones a los pacientes. En una revisión de la investigación sobre la seguridad del paciente en la atención primaria, se identificaron 21 enfoques existentes para la clasificación de la gravedad del daño. Con la Clasificación Internacional para la Seguridad del Paciente de la Organización Mundial de la Salud (OMS) como referencia, se llevó a cabo un análisis del marco de estos enfoques. A continuación, se desarrolló un nuevo sistema para la clasificación de la gravedad del daño. Para evaluar y clasificar el daño, la mayoría de los enfoques existentes usan medidas de la duración de los síntomas (11/21), la gravedad de los síntomas (11/21) y/o el nivel de intervención necesario para gestionar el daño (14/21). Sin embargo, pocos de estos enfoques explican los efectos nocivos de la hospitalización o el estrés psicológico que pueden experimentar los pacientes y/o sus familiares. El nuevo sistema de clasificación desarrollado se basa en la Clasificación Internacional para la Seguridad del Paciente de la OMS y tiene en cuenta no solo la hospitalización y el estrés psicológico, sino también los denominados casi accidentes y los resultados inciertos. Los constructos descritos tienen el potencial de aplicarse internacionalmente, en entornos de atención primaria, para mejorar tanto la detección como la prevención de incidentes que causan los daños más graves a los pacientes.

Outcomes of lung transplantation in adults with bronchiectasis.

BACKGROUND: Lung transplantation is a well-established treatment for end-stage non-cystic fibrosis bronchiectasis (BR), though information regarding outcomes of transplantation remains limited. Our results of lung transplantation for Br are reported here. METHODS: A retrospective review of case notes and transplantation databases was conducted for patients that had underwent lung transplantation for bronchiectasis at the Freeman Hospital between 1990 and 2013. RESULTS: Fourty two BR patients underwent lung transplantation, the majority (39) having bilateral sequential lung transplantation. Mean age at transplantation was 47.1 years. Pre-transplantation osteoporosis was a significant non-pulmonary morbidity (48%). Polymicrobial infection was common, with Pseudomonas aeruginosa infection frequently but not universally observed (67%). Forced expiratory volume in 1 second (% predicted) improved from a pre-transplantation mean of 0.71 L (22% predicted) to 2.56 L (79 % predicted) at 1-year post-transplantation. Our survival results were 74% at 1 year, 64% at 3 years, 61% at 5 years and 48% at 10 years. Sepsis was a common cause of early post-transplantation deaths. CONCLUSIONS: Lung transplantation for end-stage BR is a useful therapeutic option, with good survival and lung function outcomes. Survival values were similar to other bilateral lung transplants at our centre. Pre-transplantation Pseudomonas infection is common.

A framework for learning about improvement: embedded implementation and evaluation design to optimize learning.

Improving health care involves many actors, often working in complex adaptive systems. Interventions tend to be multi-factorial, implementation activities diverse, and contexts dynamic and complicated. This makes improvement initiatives challenging to describe and evaluate as matching evaluation and program designs can be difficult, requiring collaboration, trust and transparency. Collaboration is required to address important epidemiological principles of bias and confounding. If this does not take place, results may lack credibility because the association between interventions implemented and outcomes achieved is obscure and attribution uncertain. Moreover, lack of clarity about what was implemented, how it was implemented, and the context in which it was implemented often lead to disappointment or outright failure of spread and scale-up efforts. The input of skilled evaluators into the design and conduct of improvement initiatives can be helpful in mitigating these potential problems. While evaluation must be rigorous, if it is too rigid necessary adaptation and learning may be compromised. This article provides a framework and guidance on how improvers and evaluators can work together to design, implement and learn about improvement interventions more effectively.

Unpacking the black box of improvement.

During the Salzburg Global Seminar Session 565-'Better Health Care: How do we learn about improvement?', participants discussed the need to unpack the 'black box' of improvement. The 'black box' refers to the fact that when quality improvement interventions are described or evaluated, there is a tendency to assume a simple, linear path between the intervention and the outcomes it yields. It is also assumed that it is enough to evaluate the results without understanding the process of by which the improvement took place. However, quality improvement interventions are complex, nonlinear and evolve in response to local settings. To accurately assess the effectiveness of quality improvement and disseminate the learning, there must be a greater understanding of the complexity of quality improvement work. To remain consistent with the language used in Salzburg, we refer to this as 'unpacking the black box' of improvement. To illustrate the complexity of improvement, this article introduces four quality improvement case studies. In unpacking the black box, we present and demonstrate how Cynefin framework from complexity theory can be used to categorize and evaluate quality improvement interventions. Many quality improvement projects are implemented in complex contexts, necessitating an approach defined as 'probe-sense-respond'. In this approach, teams experiment, learn and adapt their changes to their local setting. Quality improvement professionals intuitively use the probe-sense-respond approach in their work but document and evaluate their projects using language for 'simple' or 'complicated' contexts, rather than the 'complex' contexts in which they work. As a result, evaluations tend to ask 'How can we attribute outcomes to the intervention?', rather than 'What were the adaptations that took place?'. By unpacking the black box of improvement, improvers can more accurately document and describe their interventions, allowing evaluators to ask the right questions and more adequately evaluate quality improvement interventions.

Practical recommendations for the evaluation of improvement initiatives.

A lack of clear guidance for funders, evaluators and improvers on what to include in evaluation proposals can lead to evaluation designs that do not answer the questions stakeholders want to know. These evaluation designs may not match the iterative nature of improvement and may be imposed onto an initiative in a way that is impractical from the perspective of improvers and the communities with whom they work. Consequently, the results of evaluations are often controversial, and attribution remains poorly understood. Improvement initiatives are iterative, adaptive and context-specific. Evaluation approaches and designs must align with these features, specifically in their ability to consider complexity, to evolve as the initiative adapts over time and to understand the interaction with local context. Improvement initiatives often identify broadly defined change concepts and provide tools for care teams to tailor these in more detail to local conditions. Correspondingly, recommendations for evaluation are best provided as broad guidance, to be tailored to the specifics of the initiative. In this paper, we provide practical guidance and recommendations that funders and evaluators can use when developing an evaluation plan for improvement initiatives that seeks to: identify the questions stakeholders want to address; develop the initial program theory of the initiative; identify high-priority areas to measure progress over time; describe the context the initiative will be applied within; and identify experimental or observational designs that will address attribution.