Integrating quality improvement into healthcare operations: A system's approach.

A palpable pulse on organizational culture is imperative for allowing senior leadership to understand the current state and use this as a starting point to measure the gap between the current state and where the organization should be to meet strategic goals related to quality and safety. Knowledge gleaned from causal analysis and coding of safety events provides the organization with that information. Our organization was unknowingly making decisions on a small quantity of coded and classified events, which led to mistakes on our journey to becoming a high-reliability organization. To remedy this, the Quality and Safety Team improved the user interface of the event reporting system and created standard work for all frontline staff, physicians, area managers and senior leaders. After several interventions, we reduced the time between reported events and documented resolution by 15.28% and increased the quantity of coded and classified safety events tenfold. These changes improved our organization's ability to make better informed decisions and plot a more precise course on the journey to becoming a high-reliability organization.

Project Earthrise: Proceedings of the Ninth Annual Conference of inVIVO Planetary Health.

The "Earthrise" photograph, taken on the 1968 Apollo 8 mission, became one of the most significant images of the 20th Century. It triggered a profound shift in environmental awareness and the potential for human unity-inspiring the first Earth Day in 1970. Taking inspiration from these events 50 years later, we initiated Project Earthrise at our 2020 annual conference of inVIVO Planetary Health. This builds on the emergent concept of planetary health, which provides a shared narrative to integrate rich and diverse approaches from all aspects of society towards shared solutions to global challenges. The acute catastrophe of the COVID-19 pandemic has drawn greater attention to many other interconnected global health, environmental, social, spiritual, and economic problems that have been underappreciated or neglected for decades. This is accelerating opportunities for greater collaborative action, as many groups now focus on the necessity of a "Great Transition". While ambitious integrative efforts have never been more important, it is imperative to apply these with mutualistic value systems as a compass, as we seek to make wiser choices. Project Earthrise is our contribution to this important process. This underscores the imperative for creative ecological solutions to challenges in all systems, on all scales with advancing global urbanization in the digital age-for personal, environmental, economic and societal health alike. At the same time, our agenda seeks to equally consider our social and spiritual ecology as it does natural ecology. Revisiting the inspiration of "Earthrise", we welcome diverse perspectives from across all dimensions of the arts and the sciences, to explore novel solutions and new normative values. Building on academic rigor, we seek to place greater value on imagination, kindness and mutualism as we address our greatest challenges, for the health of people, places and planet.

Clinical chorioamnionitis at term X: microbiology, clinical signs, placental pathology, and neonatal bacteremia - implications for clinical care.

OBJECTIVES: Clinical chorioamnionitis at term is considered the most common infection-related diagnosis in labor and delivery units worldwide. The syndrome affects 5-12% of all term pregnancies and is a leading cause of maternal morbidity and mortality as well as neonatal death and sepsis. The objectives of this study were to determine the (1) amniotic fluid microbiology using cultivation and molecular microbiologic techniques; (2) diagnostic accuracy of the clinical criteria used to identify patients with intra-amniotic infection; (3) relationship between acute inflammatory lesions of the placenta (maternal and fetal inflammatory responses) and amniotic fluid microbiology and inflammatory markers; and (4) frequency of neonatal bacteremia. METHODS: This retrospective cross-sectional study included 43 women with the diagnosis of clinical chorioamnionitis at term. The presence of microorganisms in the amniotic cavity was determined through the analysis of amniotic fluid samples by cultivation for aerobes, anaerobes, and genital mycoplasmas. A broad-range polymerase chain reaction coupled with electrospray ionization mass spectrometry was also used to detect bacteria, select viruses, and fungi. Intra-amniotic inflammation was defined as an elevated amniotic fluid interleukin-6 (IL-6) concentration ≥2.6 ng/mL. RESULTS: (1) Intra-amniotic infection (defined as the combination of microorganisms detected in amniotic fluid and an elevated IL-6 concentration) was present in 63% (27/43) of cases; (2) the most common microorganisms found in the amniotic fluid samples were Ureaplasma species, followed by Gardnerella vaginalis; (3) sterile intra-amniotic inflammation (elevated IL-6 in amniotic fluid but without detectable microorganisms) was present in 5% (2/43) of cases; (4) 26% of patients with the diagnosis of clinical chorioamnionitis had no evidence of intra-amniotic infection or intra-amniotic inflammation; (5) intra-amniotic infection was more common when the membranes were ruptured than when they were intact (78% [21/27] vs. 38% [6/16]; p=0.01); (6) the traditional criteria for the diagnosis of clinical chorioamnionitis had poor diagnostic performance in identifying proven intra-amniotic infection (overall accuracy, 40-58%); (7) neonatal bacteremia was diagnosed in 4.9% (2/41) of cases; and (8) a fetal inflammatory response defined as the presence of severe acute funisitis was observed in 33% (9/27) of cases. CONCLUSIONS: Clinical chorioamnionitis at term, a syndrome that can result from intra-amniotic infection, was diagnosed in approximately 63% of cases and sterile intra-amniotic inflammation in 5% of cases. However, a substantial number of patients had no evidence of intra-amniotic infection or intra-amniotic inflammation. Evidence of the fetal inflammatory response syndrome was frequently present, but microorganisms were detected in only 4.9% of cases based on cultures of aerobic and anaerobic bacteria in neonatal blood.

Response to SSRI intervention and amygdala activity during self-referential processing in major depressive disorder.

There are conflicting reports on the impact of antidepressants on neural reactions for positive information. We thus hypothesized that there would be clinically important individual differences in neural reactivity to positive information during SSRI therapy. We further predicted that only those who responded to SSRIs would show increased amygdala reactivity to positive information following treatment to a level similar to that seen in healthy participants. Depressed individuals (n = 17) underwent fMRI during performance of a task involving rating the self-relevance of emotionally positive and negative cue words before and after receiving 12 weeks of SSRI therapy. At post-treatment, SSRI responders (n = 11) had increased amygdala activity in response to positive stimuli, and decreased activity in response to negative stimuli, compared to non-responders (n = 6). Results suggest that normalizing amygdala responses to salient information is a correlate of SSRI efficacy. Second line interventions that modulate amygdala activity, such as fMRI neurofeedback, may be beneficial in those who do not respond to SSRI medications.

A Non-Lethal Osteogenesis Imperfecta Type II Mutation.

BACKGROUND: We discuss the ethical decision points in a case report that describes a novel COL1A1 mutation associated to Osteogenesis Imperfecta type II, but with a non-lethal outcome. CASE: A 33-year-old female underwent a 21-week ultrasound that revealed short bowed femurs and humeri with old fractures and bowed tibias and fibulas. Amniotic fluid testing revealed a novel COL1A1 mutation (c.1840G>A; p.Gly614Arg). OI Type II diagnosis was made. A previously reported mutation of the same gene but different locus (c.1840G>C; p.Gly614Arg) led to a lethal form of OI type II. The newborn was delivered via a cesarean delivery and intravenous bisphosphonates (Zaledronic acid) was administered every 3 months. Currently the infant is 22 months old, is growing, with mild bilateral conductive hearing loss. CONCLUSION: The unexpected clinical outcome should serve as a reminder that phenotypic variability can occur with genetic mutations. Our case shows that the diagnosis of the type of OI should be based not only on clinical findings and genetic investigations but also on the clinical course over time.

Weak functional connectivity in the human fetal brain prior to preterm birth.

It has been suggested that neurological problems more frequent in those born preterm are expressed prior to birth, but owing to technical limitations, this has been difficult to test in humans. We applied novel fetal resting-state functional MRI to measure brain function in 32 human fetuses in utero and found that systems-level neural functional connectivity was diminished in fetuses that would subsequently be born preterm. Neural connectivity was reduced in a left-hemisphere pre-language region, and the degree to which connectivity of this left language region extended to right-hemisphere homologs was positively associated with the time elapsed between fMRI assessment and delivery. These results provide the first evidence that altered functional connectivity in the preterm brain is identifiable before birth. They suggest that neurodevelopmental disorders associated with preterm birth may result from neurological insults that begin in utero.

Distress Screening and Management in an Outpatient VA Cancer Clinic: A Pilot Project Involving Ambulatory Patients Across the Disease Trajectory.

Screening all patients for distress addressed practical, psychosocial, physical, and spiritual needs does not seem to be burdensome for patients or providers at an outpatient cancer center.

Comparing State Legislative Aides' Perspectives on Tobacco Policymaking in States With Strong and Weak Policies: A Qualitative Study.

PURPOSE: The study compared perceptions of state legislative aides about tobacco policymaking in states with strong and weak tobacco control policies. APPROACH: Qualitative in-depth interviews carried out in 2009. SETTING: The US states were ranked on a combination of tobacco prevention funding, taxes, and presence of smoke-free policies. States at the top and bottom of the rankings were chosen. PARTICIPANTS: Interviews were conducted with 10 legislative aides in 5 states with strong tobacco control policies and 10 aides in 7 states with weak policies. METHOD: Twenty semistructured interviews were conducted, coded, and analyzed using a consensus coding process. RESULTS: Tobacco control was a lower priority in states with weak policies, and respondents from these states listed more barriers to tobacco control policymaking than those from states with strong policies. Successful arguments for tobacco control emphasized operational applications, for example, enhanced revenue from tobacco taxes or safety of children and employees. CONCLUSION: Our findings support propositions posited in the Advocacy Coalition Framework. They point to the preeminence of contextual factors, notably political leanings and economic climate on success of policy change efforts. Lessons learned from participants from states with strong policy nonetheless show promise for success in states with weak policy.

Using the framework of corporate culture in "mergers" to support the development of a cultural basis for integrative medicine - guidance for building an integrative medicine department or service.

BACKGROUND: An increasing number of clinics offer complementary or integrative medicine services; however, clear guidance about how complementary medicine could be successfully and efficiently integrated into conventional health care settings is still lacking. Combining conventional and complementary medicine into integrative medicine can be regarded as a kind of merger. In a merger, two or more organizations - usually companies - are combined into one in order to strengthen the companies financially and strategically. The corporate culture of both merger partners has an important influence on the integration. PURPOSE: The aim of this project was to transfer the concept of corporate culture in mergers to the merging of two medical systems. METHODS: A two-step approach (literature analyses and expert consensus procedure) was used to develop practical guidance for the development of a cultural basis for integrative medicine, based on the framework of corporate culture in "mergers," which could be used to build an integrative medicine department or integrative medicine service. RESULTS: Results include recommendations for general strategic dimensions (definition of the medical model, motivation for integration, clarification of the available resources, development of the integration team, and development of a communication strategy), and recommendations to overcome cultural differences (the clinic environment, the professional language, the professional image, and the implementation of evidence-based medicine). CONCLUSION: The framework of mergers in corporate culture provides an understanding of the difficulties involved in integrative medicine projects. The specific recommendations provide a good basis for more efficient implementation.

Age-related increases in long-range connectivity in fetal functional neural connectivity networks in utero.

Formation of operational neural networks is one of the most significant accomplishments of human fetal brain growth. Recent advances in functional magnetic resonance imaging (fMRI) have made it possible to obtain information about brain function during fetal development. Specifically, resting-state fMRI and novel signal covariation approaches have opened up a new avenue for non-invasive assessment of neural functional connectivity (FC) before birth. Early studies in this area have unearthed new insights about principles of prenatal brain function. However, very little is known about the emergence and maturation of neural networks during fetal life. Here, we obtained cross-sectional rs-fMRI data from 39 fetuses between 24 and 38 weeks postconceptual age to examine patterns of connectivity across ten neural FC networks. We identified primitive forms of motor, visual, default mode, thalamic, and temporal networks in the human fetal brain. We discovered the first evidence of increased long-range, cerebral-cerebellar, cortical-subcortical, and intra-hemispheric FC with advancing fetal age. Continued aggregation of data about fundamental neural connectivity systems in utero is essential to establishing principles of connectomics at the beginning of human life. Normative data provides a vital context against which to compare instances of abnormal neurobiological development.

Preparing Trainees to Deliver Patient-Centered Care in an Ambulatory Cancer Clinic.

The purpose of this paper is to describe how an interprofessional cancer care clinic at the Cleveland Veteran's Affairs Medical Center (VAMC) is training health care professionals in patient-centered care. Teaching strategies included patient huddle discussions pre- and post-clinic, role-play, noon "lunch and learn" conferences, and, most importantly, patient interactions, which were evaluated with the patient perception of patient centeredness (PPPC) instrument. This instrument is designed to capture patient and provider perceptions of the provider's patient centeredness. Early findings demonstrated that patient responses were overwhelmingly positive and lacked variability. In response to the lack of variability, the educator in the clinic participated in the evaluation and patient, provider, and trainer responses were compared. Discussion of the weekly evaluations provided helpful formative feedback on patient centeredness to the trainees rotating through this specialty care clinic.

Intrinsic functional brain architecture derived from graph theoretical analysis in the human fetus.

The human brain undergoes dramatic maturational changes during late stages of fetal and early postnatal life. The importance of this period to the establishment of healthy neural connectivity is apparent in the high incidence of neural injury in preterm infants, in whom untimely exposure to ex-uterine factors interrupts neural connectivity. Though the relevance of this period to human neuroscience is apparent, little is known about functional neural networks in human fetal life. Here, we apply graph theoretical analysis to examine human fetal brain connectivity. Utilizing resting state functional magnetic resonance imaging (fMRI) data from 33 healthy human fetuses, 19 to 39 weeks gestational age (GA), our analyses reveal that the human fetal brain has modular organization and modules overlap functional systems observed postnatally. Age-related differences between younger (GA <31 weeks) and older (GA≥31 weeks) fetuses demonstrate that brain modularity decreases, and connectivity of the posterior cingulate to other brain networks becomes more negative, with advancing GA. By mimicking functional principles observed postnatally, these results support early emerging capacity for information processing in the human fetal brain. Current technical limitations, as well as the potential for fetal fMRI to one day produce major discoveries about fetal origins or antecedents of neural injury or disease are discussed.

Toward clinically useful neuroimaging in depression treatment: prognostic utility of subgenual cingulate activity for determining depression outcome in cognitive therapy across studies, scanners, and patient characteristics.

CONTEXT Among depressed individuals not receiving medication in controlled trials, 40% to 60% respond to cognitive therapy (CT). Multiple previous studies suggest that activity in the subgenual anterior cingulate cortex (sgACC; Brodmann area 25) predicts outcome in CT for depression, but these results have not been prospectively replicated. OBJECTIVE To examine whether sgACC activity is a reliable and robust prognostic outcome marker of CT for depression and whether sgACC activity changes in treatment. DESIGN Two inception cohorts underwent assessment with functional magnetic resonance imaging using different scanners on a task sensitive to sustained emotional information processing before and after 16 to 20 sessions of CT, along with a sample of control participants who underwent testing at comparable intervals. SETTING A hospital outpatient clinic. PATIENTS Forty-nine unmedicated depressed adults and 35 healthy controls. MAIN OUTCOME MEASURES Pretreatment sgACC activity in an a priori region in response to negative words was correlated with residual severity and used to classify response and remission. RESULTS As expected, in both samples, participants with the lowest pretreatment sustained sgACC reactivity in response to negative words displayed the most improvement after CT (R2 = 0.29, >75% correct classification of response, >70% correct classification of remission). Other a priori regions explained additional variance. Response/remission in cohort 2 was predicted based on thresholds from cohort 1. Subgenual anterior cingulate activity remained low for patients in remission after treatment. CONCLUSIONS Neuroimaging provides a quick, valid, and clinically applicable way of assessing neural systems associated with treatment response/remission. Subgenual anterior cingulate activity, in particular, may reflect processes that interfere with treatment (eg, emotion generation) in addition to its putative regulatory role; alternately, its absence may facilitate treatment response.

Young adults' perceptions about established and emerging tobacco products: results from eight focus groups.

INTRODUCTION: In order to sustain their market, tobacco producers target young adults through novel product design and marketing strategies. Public health professionals need to understand young adults' risks perceptions about and use of new tobacco products to best inform tobacco control interventions. METHODS: In 2009, researchers conducted 8 focus groups with 67 young adults stratified by self-reported tobacco use and nonuse, residence in rural and urban areas, and living in a state with or without a statewide smoking restriction policy. Participants provided feedback about their knowledge and risk perceptions about and use of tobacco products and marketing. RESULTS: Participants reported a high level of familiarity with a wide range of novel tobacco products. A great deal of confusion and disagreement appeared with regard to absolute and relative risk of different tobacco products. Participants readily discussed using smokeless tobacco products as alternatives to smoking when smoking is prohibited. Fewer differences in tobacco-related knowledge risk perceptions and use were found between urban and rural participants and those in smoke-free policy and nonpolicy states than between user and nonuser groups. Both users and nonusers were familiar with and skeptical about tobacco marketing and prevention efforts. CONCLUSIONS: Young adults are familiar with many tobacco products, but they convey little understanding of relative risks of new or trendy tobacco products, such as snus or hookah. Mindful of industry innovation, tobacco control advocates must continuously update prevention efforts, seeking new strategies to limit promotion, marketing, and use of new and conventional products.

The emerging use of technology for the treatment of depression and other neuropsychiatric disorders.

BACKGROUND: Our objective is to review emerging technologies intended for the treatment of depression and other neuropsychiatric disorders. METHODS: These technologies include repetitive transcranial magnetic stimulation (rTMS), magnetic seizure therapy (MST), vagus nerve stimulation (VNS), deep brain stimulation (DBS), cortical brain stimulation (CBS), and quantitative electroencephalography (QEEG). RESULTS: The rationale for these technologies, their mechanisms of action, and how they are used in clinical practice are described. rTMS and VNS are effective for treatment-resistant depression. DBS is effective for resistant obsessive-compulsive disorder. QEEG can help predict a patient's response to an antidepressant. All of these technologies continue to be investigated in treatment studies. CONCLUSIONS: As these and other emerging technologies for depression and other neuropsychiatric disorders are development and applied, psychiatrists should understand the rationale for these modalities, how they work, and how they can be used in clinical practice.

Concurrent anxiety and substance use disorders among outpatients with major depression: clinical features and effect on treatment outcome.

BACKGROUND: Depressed patients often present with comorbid anxiety and/or substance use disorder. This report compares the four groups defined by the disorders (anxiety disorder, substance use disorder, both, and neither) in terms of baseline clinical and sociodemographic features, and in terms of outcomes following treatment with citalopram (a selective serotonin reuptake inhibitor). METHODS: The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial enrolled 2838 outpatients with non-psychotic major depressive disorder (MDD) from 18 primary and 23 psychiatric care clinics. Clinical and sociodemographic features were assessed at baseline. These baseline features and the treatment outcomes following treatment with citalopram were compared among the four groups. RESULTS: Participants with non-psychotic MDD and comorbid anxiety and/or substance use disorder showed several distinctive baseline sociodemographic and clinical features. They also showed greater depression severity; length of illness; likelihood of anxious, atypical or melancholic features; more intolerance/attrition; and worse remission/response outcomes with treatment. Participants with either anxiety or substance use disorder showed outcomes generally intermediate between those with both and those with neither. CONCLUSIONS: Comorbid anxiety and/or substance use disorder are clinically identifiable, and their presence may define distinct MDD subgroups that have more problems and worse pharmacological treatment outcomes. They may benefit from more aggressive, multi-faceted treatment and psychosocial rehabilitation targeted at reducing their psychological comorbidity and functional impairment.

Measurement of 5-HT1A receptor binding in depressed adults before and after antidepressant drug treatment using positron emission tomography and [11C]WAY-100635.

OBJECTIVE: To assess effects of chronic antidepressant drug treatment on serotonin type-1A receptor (5-HT(1A)R) binding potential (BP) in major depressive disorder. METHODS: Depressed subjects (n = 27) were imaged using PET and [(11)C]WAY-100635 at baseline and following a median of 9.4 weeks of treatment with selective serotonin reuptake inhibitor or dual reuptake inhibitor antidepressant agents. Fifteen subjects had complete pre- and post-treatment scan data. The 5-HT(1A)R BP was derived from the tissue time-radioactivity concentrations from regions-of-interest defined a priori, using a simplified reference tissue model (SRTM), and in a subset of subjects, compartmental modeling (CMOD). RESULTS: Chronic treatment had no effect on pre- or post-synaptic 5-HT(1A)R BP, as confirmed by both the SRTM and CMOD analyses. These results were unaffected by treatment response status and were consistent across brain regions. Among the 22 subjects for whom the clinical response-to-treatment was established, the treatment nonresponders (n = 7) had higher baseline BP values in the left (P = 0.01) and right orbital cortex (P = 0.02) than the responders (n = 15). CONCLUSIONS: Chronic antidepressant drug treatment did not significantly change cerebral 5-HT(1A)R binding, consistent with preclinical evidence that the alterations in serotonergic function associated with antidepressant drug administration are not accompanied by changes in 5-HT(1A)R density. Higher baseline 5-HT(1A)R binding was associated with poorer response to treatment.

Factors associated with health-related quality of life among outpatients with major depressive disorder: a STAR*D report.

OBJECTIVE: Major depressive disorder (MDD) is often chronic and is often associated with significant morbidity and mortality. The importance of assessing disability and health-related quality of life (HRQOL) in patients with MDD has only recently been recognized. The aim of this study was to examine sociodemographic and clinical correlates of HRQOL in a large cohort of outpatients with MDD. METHOD: Baseline assessments were completed for 1500 consecutive patients enrolled in the Sequenced Treatment Alternatives to Relieve Depression trial, including sociodemographic characteristics and measures of depressive symptom severity, clinical features, and HRQOL. Multiple domains of HRQOL were assessed with the 12-item Short Form Health Survey, the Work and Social Adjustment Scale, and the Quality of Life Enjoyment and Satisfaction Questionnaire. The current analyses were conducted on HRQOL data available for 1397 of the 1500 subjects. RESULTS: Greater symptom severity was associated with reduced HRQOL by all measures. Even after age and symptom severity were controlled for, a number of clinical features and sociodemographic characteristics were independently associated with HRQOL in multiple domains, including age at onset of MDD, ethnicity, marital status, employment status, education level, insurance status, and monthly household income. CONCLUSION: Results strongly suggest the need to assess HRQOL in addition to symptoms in order to gauge the true severity of MDD. This study also highlights the necessity of measuring HRQOL in multiple domains. These results have implications for the assessment of remission and functional recovery in the treatment of MDD.

Modified Bishop's score and induction of labor in patients with a previous cesarean delivery.

OBJECTIVES: The purpose of this study was to evaluate the association between preinduction modified Bishop's score and obstetric outcome, including successful vaginal birth after prior cesarean (VBAC) and uterine rupture in patients with a previous cesarean undergoing induction of labor. STUDY DESIGN: Medical records of all patients who had an induction of labor after a previous cesarean in our institution between 1988 and 2002 were reviewed. Patients were divided into 4 groups according to the modified Bishop's score (0 to 2, 3 to 5, 6 to 8, and 9 to 12). The rates of successful VBAC, symptomatic uterine rupture, and other obstetric outcomes were evaluated in each group. Multivariate regression analyses were performed to adjust for confounding factors. RESULTS: Out of 685 women included in the study, 187 (27.3%) had a modified Bishop's score <2, 276 (40.3%) of 3 to 5, 189 (27.6%) of 6 to 8, and 33 (4.8%) of 9 to 12. The rate of successful VBAC significantly correlated with the modified Bishop's score (57.5%, 64.5%, 82.5%, and 97.0%, respectively, P < .001). However, the rate of uterine rupture was not statistically significant between the groups (2.1%, 1.8%, 0.5%, 0.0%, P=.48). After adjusting for confounding variables, a modified Bishop's score >/=6 remained associated with successful VBAC (odds ratio [OR] 2.07, 95% CI 1.28-3.35, P < .001). CONCLUSION: The modified Bishop's score before induction of labor is an independent factor associated with successful VBAC.