Interpretation of statistical findings in randomised trials: a survey of statisticians using thematic analysis of open-ended questions.

BACKGROUND: Dichotomisation of statistical significance, rather than interpretation of effect sizes supported by confidence intervals, is a long-standing problem. METHODS: We distributed an online survey to clinical trial statisticians across the UK, Australia and Canada asking about their experiences, perspectives and practices with respect to interpretation of statistical findings from randomised trials. We report a descriptive analysis of the closed-ended questions and a thematic analysis of the open-ended questions. RESULTS: We obtained 101 responses across a broad range of career stages (24% professors; 51% senior lecturers; 22% junior statisticians) and areas of work (28% early phase trials; 44% drug trials; 38% health service trials). The majority (93%) believed that statistical findings should be interpreted by considering (minimal) clinical importance of treatment effects, but many (61%) said quantifying clinically important effect sizes was difficult, and fewer (54%) followed this approach in practice. Thematic analysis identified several barriers to forming a consensus on the statistical interpretation of the study findings, including: the dynamics within teams, lack of knowledge or difficulties in communicating that knowledge, as well as external pressures. External pressures included the pressure to publish definitive findings and statistical review which can sometimes be unhelpful but can at times be a saving grace. However, the concept of the minimally important difference was identified as a particularly poorly defined, even nebulous, construct which lies at the heart of much disagreement and confusion in the field. CONCLUSION: The majority of participating statisticians believed that it is important to interpret statistical findings based on the clinically important effect size, but report this is difficult to operationalise. Reaching a consensus on the interpretation of a study is a social process involving disparate members of the research team along with editors and reviewers, as well as patients who likely have a role in the elicitation of minimally important differences.

Pharmacies in informal settlements: a retrospective, cross-sectional household and health facility survey in four countries.

BACKGROUND: Slums or informal settlements characterize most large cities in LMIC. Previous evidence suggests pharmacies may be the most frequently used source of primary care in LMICs but that pharmacy services are of variable quality. However, evidence on pharmacy use and availability is very limited for slum populations. METHODS: We conducted household, individual, and healthcare provider surveys and qualitative observations on pharmacies and pharmacy use in seven slum sites in four countries (Nigeria, Kenya, Pakistan, and Bangladesh). All pharmacies and up to 1200 households in each site were sampled. Adults and children were surveyed about their use of healthcare services and pharmacies were observed and their services, equipment, and stock documented. RESULTS: We completed 7692 household and 7451 individual adults, 2633 individual child surveys, and 157 surveys of pharmacies located within the seven sites. Visit rates to pharmacies and drug sellers varied from 0.1 (Nigeria) to 3.0 (Bangladesh) visits per person-year, almost all of which were for new conditions. We found highly variable conditions in what constituted a "pharmacy" across the sites and most pharmacies did not employ a qualified pharmacist. Analgesics and antibiotics were widely available but other categories of medications, particularly those for chronic illness were often not available anywhere. The majority of pharmacies lacked basic equipment such as a thermometer and weighing scales. CONCLUSIONS: Pharmacies are locally and widely available to residents of slums. However, the conditions of the facilities and availability of medicines were poor and prices relatively high. Pharmacies may represent a large untapped resource to improving access to primary care for the urban poor.

A Program to Prevent Catheter-Associated Urinary Tract Infection in Acute Care.

BACKGROUND: Catheter-associated urinary tract infection (UTI) is a common device-associated infection in hospitals. Both technical factors--appropriate catheter use, aseptic insertion, and proper maintenance--and socioadaptive factors, such as cultural and behavioral changes in hospital units, are important in preventing catheter-associated UTI. METHODS: The national Comprehensive Unit-based Safety Program, funded by the Agency for Healthcare Research and Quality, aimed to reduce catheter-associated UTI in intensive care units (ICUs) and non-ICUs. The main program features were dissemination of information to sponsor organizations and hospitals, data collection, and guidance on key technical and socioadaptive factors in the prevention of catheter-associated UTI. Data on catheter use and catheter-associated UTI rates were collected during three phases: baseline (3 months), implementation (2 months), and sustainability (12 months). Multilevel negative binomial models were used to assess changes in catheter use and catheter-associated UTI rates. RESULTS: Data were obtained from 926 units (59.7% were non-ICUs, and 40.3% were ICUs) in 603 hospitals in 32 states, the District of Columbia, and Puerto Rico. The unadjusted catheter-associated UTI rate decreased overall from 2.82 to 2.19 infections per 1000 catheter-days. In an adjusted analysis, catheter-associated UTI rates decreased from 2.40 to 2.05 infections per 1000 catheter-days (incidence rate ratio, 0.86; 95% confidence interval [CI], 0.76 to 0.96; P=0.009). Among non-ICUs, catheter use decreased from 20.1% to 18.8% (incidence rate ratio, 0.93; 95% CI, 0.90 to 0.96; P<0.001) and catheter-associated UTI rates decreased from 2.28 to 1.54 infections per 1000 catheter-days (incidence rate ratio, 0.68; 95% CI, 0.56 to 0.82; P<0.001). Catheter use and catheter-associated UTI rates were largely unchanged in ICUs. Tests for heterogeneity (ICU vs. non-ICU) were significant for catheter use (P=0.004) and catheter-associated UTI rates (P=0.001). CONCLUSIONS: A national prevention program appears to reduce catheter use and catheter-associated UTI rates in non-ICUs. (Funded by the Agency for Healthcare Research and Quality.).

Weekend specialist intensity and admission mortality in acute hospital trusts in England: a cross-sectional study.

BACKGROUND: Increased mortality rates associated with weekend hospital admission (the so-called weekend effect) have been attributed to suboptimum staffing levels of specialist consultants. However, evidence for a causal association is elusive, and the magnitude of the weekend specialist deficit remains unquantified. This uncertainty could hamper efforts by national health systems to introduce 7 day health services. We aimed to examine preliminary associations between specialist intensity and weekend admission mortality across the English National Health Service. METHODS: Eligible hospital trusts were those in England receiving unselected emergency admissions. On Sunday June 15 and Wednesday June 18, 2014, we undertook a point prevalence survey of hospital specialists (consultants) to obtain data relating to the care of patients admitted as emergencies. We defined specialist intensity at each trust as the self-reported estimated number of specialist hours per ten emergency admissions between 0800 h and 2000 h on Sunday and Wednesday. With use of data for all adult emergency admissions for financial year 2013-14, we compared weekend to weekday admission risk of mortality with the Sunday to Wednesday specialist intensity ratio within each trust. We stratified trusts by size quintile. FINDINGS: 127 of 141 eligible acute hospital trusts agreed to participate; 115 (91%) trusts contributed data to the point prevalence survey. Of 34,350 clinicians surveyed, 15,537 (45%) responded. Substantially fewer specialists were present providing care to emergency admissions on Sunday (1667 [11%]) than on Wednesday (6105 [42%]). Specialists present on Sunday spent 40% more time caring for emergency patients than did those present on Wednesday (mean 5·74 h [SD 3·39] vs 3·97 h [3·31]); however, the median specialist intensity on Sunday was only 48% (IQR 40-58) of that on Wednesday. The Sunday to Wednesday intensity ratio was less than 0·7 in 104 (90%) of the contributing trusts. Mortality risk among patients admitted at weekends was higher than among those admitted on weekdays (adjusted odds ratio 1·10, 95% CI 1·08-1·11; p<0·0001). There was no significant association between Sunday to Wednesday specialist intensity ratios and weekend to weekday mortality ratios (r -0·042; p=0·654). INTERPRETATION: This cross-sectional analysis did not detect a correlation between weekend staffing of hospital specialists and mortality risk for emergency admissions. Further investigation is needed to evaluate whole-system secular change during the implementation of 7 day services. Policy makers should exercise caution before attributing the weekend effect mainly to differences in specialist staffing. FUNDING: National Institute for Health Research Health Services and Delivery Research Programme.

Protocol-Based Resuscitation Bundle to Improve Outcomes in Septic Shock Patients: Evaluation of the Michigan Health and Hospital Association Keystone Sepsis Collaborative.

OBJECTIVES: To evaluate the impact of a multi-ICU quality improvement collaborative implementing a protocol-based resuscitation bundle to treat septic shock patients. DESIGN: A difference-in-differences analysis compared patient outcomes in hospitals participating in the Michigan Health & Hospital Association Keystone Sepsis collaborative (n = 37) with noncollaborative hospitals (n = 50) pre- (2010-2011) and postimplementation (2012-2013). Collaborative hospitals were also stratified as high (n = 19) and low (n = 18) adherence based on their overall bundle adherence. SETTING: Eighty-seven Michigan hospitals with ICUs. PATIENTS: We compared 22,319 septic shock patients in collaborative hospitals compared to 26,055 patients in noncollaborative hospitals using the Michigan Inpatient Database. INTERVENTIONS: Multidisciplinary ICU teams received informational toolkits, standardized screening tools, and continuous quality improvement, aided by cultural improvement. MEASUREMENTS AND MAIN RESULTS: In-hospital mortality and hospital length of stay significantly improved between pre- and postimplementation periods for both collaborative and noncollaborative hospitals. Comparing collaborative and noncollaborative hospitals, we found no additional reductions in mortality (odds ratio, 0.94; 95% CI, 0.87-1.01; p = 0.106) or length of stay (-0.3 d; 95% CI, -0.7 to 0.1 d; p = 0.174). Compared to noncollaborative hospitals, high adherence hospitals had significant reductions in mortality (odds ratio, 0.84; 95% CI, 0.79-0.93; p < 0.001) and length of stay (-0.7 d; 95% CI, -1.1 to -0.2; p < 0.001), whereas low adherence hospitals did not (odds ratio, 1.07; 95% CI, 0.97-1.19; p = 0.197; 0.2 d; 95% CI, -0.3 to 0.8; p = 0.367). CONCLUSIONS: Participation in the Keystone Sepsis collaborative was unable to improve patient outcomes beyond concurrent trends. High bundle adherence hospitals had significantly greater improvements in outcomes, but further work is needed to understand these findings.

Raw, Unadulterated African Honey for Ulcer Healing in Leprosy: Protocol for the Honey Experiment on Leprosy Ulcer (HELP) Randomized Controlled Trial.

Background: Leprosy leads to nerve damage and slow-healing ulcers, which are treatable with routine therapy. There has been a recent resurgence of interest in the use of honey for the treatment of different kinds of wounds. Objective: The aim of this study, Honey Experiment on Leprosy Ulcer (HELP), is to evaluate the healing properties of raw, unadulterated African honey in comparison with normal saline dressing for the treatment leprosy ulcers. Methods: This is a multicenter, comparative, prospective, single-blinded, parallel-group, and 1:1 individually randomized controlled trial to be conducted at The Leprosy Referral Hospital, Chanchaga in Minna, Niger State, North Central Nigeria, and St. Benedict Tuberculosis and Leprosy Rehabilitation Hospital in Ogoja, Cross River State, South-South Nigeria. Raw, unadulterated honey will be used in the ulcer dressing of eligible, consenting participants in the intervention group, whereas those in the control group will be treated by dressing with normal saline. The main outcomes will be the proportion of complete healing and the rate of healing up to 84 days after randomization. Follow-up will be conducted 6 months after randomization. We aim to enroll 90-130 participants into the study. Blinded observers will examine photographs of ulcers to determine the outcomes. Results: The recruitment of trial participants began on March 14, 2022, and has been continuing for approximately 24 months. Conclusions: Our study will provide an unbiased estimate of the effect of honey on the healing of neuropathic ulcers.

Diverse attitudes to and understandings of spontaneous awakening trials: results from a statewide quality improvement collaborative*.

OBJECTIVES: Spontaneous awakening trials (SATs) improve outcomes in mechanically ventilated patients, but implementation remains erratic. We examined variation in reported practice, prevalence of attitudes and fears regarding spontaneous awakening trials, and organizational practices associated with routine implementation of spontaneous awakening trials in an ICU quality improvement collaborative. DESIGN: Written survey. SETTING: Michigan Health and Hospital Association's Keystone ICU, a quality improvement collaborative of 73 hospitals. SUBJECTS: Attendees of the yearly Keystone ICU meeting, January 2011, including nurses, physicians, hospital administrators, and other healthcare professionals. INTERVENTION: Respondents were asked about institutional characteristics, spontaneous awakening trial practice, attitudes and barriers regarding spontaneous awakening trials, and organizational cultural characteristics that might influence SAT practice. The association of organizational cultural characteristics and attitudes with reported spontaneous awakening trial use was evaluated using logistic regression. MEASUREMENTS AND MAIN RESULTS: Three hundred nineteen participants attended the meeting. The survey response rate was 83.4%. Respondents reported wide variation in approach to spontaneous awakening trial performance and patient selection. 48.6% of respondents reported regular spontaneous awakening trial use, defined as greater than 75% of mechanically ventilated patients undergoing spontaneous awakening trials each day. In bivariable analysis, addressing sedation goals routinely in rounds and having spontaneous awakening trials as part of unit culture were positively associated with regular spontaneous awakening trial use, whereas the perception that spontaneous awakening trials increased short-term adverse effects, staff fears of spontaneous awakening trials, and the perception that spontaneous awakening trials are hard work were negatively associated with regular spontaneous awakening trial use. In multivariable analysis, only addressing sedation in rounds (odds ratio, 2.85 [95% CI, 1.55-5.23]), incorporation of spontaneous awakening trials into unit culture (odds ratio, 3.36 [95% CI, 1.75-6.43]), and the perception that spontaneous awakening trials are hard work (odds ratio, 0.53 [95% CI, 0.30-0.96]) remained statistically significantly associated with regular spontaneous awakening trial use. Respondents in managerial positions were less likely to perceive spontaneous awakening trials as hard work (odds ratio, 0.44 [95% CI, 0.22-0.85]). CONCLUSIONS: Even in a motivated statewide quality improvement collaborative, spontaneous awakening trial practice varies widely and concerns persist regarding spontaneous awakening trials. Cultural practices may counteract the effect of concerns regarding spontaneous awakening trials and are associated with increased performance of this beneficial intervention. Patient selection should be a focus for continuing medical education. Differences in perception of work between management and staff may also be a focus for improved communication.

Thrombolysis for acute ischemic stroke in Joint Commission-certified and -noncertified hospitals in Michigan.

BACKGROUND: The Joint Commission (JC) for Accreditation of Healthcare Organizations has devised disease specific certification programs for hospitals, including stroke. JC certification as a primary stroke center (PSC) suggests that the hospital has critical measures in place to ensure improving stroke outcomes over the long term. In this study, we focused on the delivery of care for patients with acute ischemic and compared differences in JC-certified and -noncertified centers in Michigan. METHODS: We performed a systematic chart review of patients with acute ischemic stroke from 10 Michigan hospitals, half of whom were JC-certified PSCs. Sixty charts were randomly chosen from 1 calendar year from each hospital. An experienced nurse performed the data abstraction, and data analysis was performed with the Fisher exact test. RESULTS: A total of 602 charts--of which 302 were from JC-certified PSCs--were chosen for the study. The 2 groups were similar with regard to stroke risk factors except that there were significantly more patients with atrial fibrillation in noncertified centers and there were more African American patients in JC-certified PSCs. Significantly more patients were considered for thrombolytic therapy in JC-certified PSCs compared to noncertified centers (90.4% v 66%; P = .0001). Overall, 3.8% of patients had received thrombolytic therapy without any significant difference between JC-certified PSCs and noncertified centers (4.6% v 3%; adjusted odds ratio 1.64; 95% confidence interval 0.64-4.19; P = .87). However, thrombolysis rates among eligible patients was significantly higher in the JC-certified PSCs (48.2% v 8.8%; P = .0001). The most common reason documented for not giving thrombolytic therapy was late arrival outside the therapeutic window, which was more common in JC-certified PSCs (72.8% v 55.6%; P = .0001) compared to noncertified centers. Seventy-four percent of patients from JC-certified PSCs were discharged home or to inpatient rehabilitation facility compared to 71% (P = .38) from noncertified hospitals. The mean length of stay was marginally shorter in JC-certified PSCs compared to noncertified centers (5.53 v 6.25 days; P = .08). CONCLUSIONS: Rates of thrombolysis administration for acute stroke patients across Michigan were low in both JC-certified and noncertified hospitals, although better processes were in place in JC-certified PSCs. While there was no overall difference in the administration of thrombolytic treatment, a greater number of the eligible patients received thrombolysis in the certified centers. There was a tendency to shorter lengths of stay at JC-certified PSCs, but there was no significant difference in discharge to home, inpatient rehabilitation, or inpatient mortality in this study.

Are racial disparities in stroke care still prevalent in certified stroke centers?

Racial differences in stroke risk and risk factor prevalence are well established. The present study explored racial differences in the delivery of care to patients with acute stroke between Joint Commission (JC)-certified hospitals and noncertified hospitals. A retrospective chart review was conducted in patients sustaining ischemic stroke admitted to 5 JC-certified centers and 5 noncertified hospitals. Demographic data, risk factors, utilization of acute stroke therapies, and compliance with core measures were recorded. Racial disparities were investigated in the entire group as well as for JC-certified and noncertified hospitals separately. A total of 574 patients (25.1% African Americans) were included. African Americans were significantly younger and more likely to have previous stroke, whereas Caucasians were more likely to have coronary disease and atrial fibrillation. There were no racial differences in other risk factors or baseline functions. Median National Institutes of Health Stroke Scale scores were similar in African Americans and Caucasians, as were proportions receiving intravenous tissue plasminogen activator (tPA) therapy (2.1% in African Americans, 3.5% in Caucasians; P = .40) and intervention (4.2% in African Americans, 6.8% in Caucasians; P = .26). Caucasians were more likely to arrive by emergency medical services (65.5% vs 51.5%; P = .004), to be evaluated by a stroke team (19.1% vs 7.7%; P = .001), and to have a documented National Institutes of Health Stroke Scale score (40.2% vs 29.9%; P = .03). African Americans often did not receive intravenous tPA because of a delay in arrival. African Americans performed better on virtually all stroke care variables in JC-certified centers. JC certification reduced disparity in certain variables, including tPA and deep venous thrombosis prophylaxis administration. Important racial disparities exist in the delivery of several acute stroke care variables. Efforts must be focused on eliminating disparities in prehospital delays. Guideline-based care tendered at JC-certified centers might help narrow disparities in acute stroke care delivery.

Perceived quality of care and choice of healthcare provider in informal settlements.

When a person chooses a healthcare provider, they are trading off cost, convenience, and a latent third factor: "perceived quality". In urban areas of lower- and middle-income countries (LMICs), including slums, individuals have a wide range of choice in healthcare provider, and we hypothesised that people do not choose the nearest and cheapest provider. This would mean that people are willing to incur additional cost to visit a provider they would perceive to be offering better healthcare. In this article, we aim to develop a method towards quantifying this notion of "perceived quality" by using a generalised access cost calculation to combine monetary and time costs relating to a visit, and then using this calculated access cost to observe facilities that have been bypassed. The data to support this analysis comes from detailed survey data in four slums, where residents were questioned on their interactions with healthcare services, and providers were surveyed by our team. We find that people tend to bypass more informal local services to access more formal providers, especially public hospitals. This implies that public hospitals, which tend to incur higher access costs, have the highest perceived quality (i.e., people are more willing to trade cost and convenience to visit these services). Our findings therefore provide evidence that can support the 'crowding out' hypothesis first suggested in a 2016 Lancet Series on healthcare provision in LMICs.

Extubation of Patients Receiving Vasopressor Infusions: Results of a Survey on Statewide Practices.

Current guidelines recommend extubation only if a patient is not receiving vasopressor therapy or is receiving minimal doses of vasopressors. However, recent data indicate that extubation of patients receiving higher vasopressor doses may be safe. This study was undertaken to examine practices regarding extubation of patients receiving vasopressor therapy reported by clinician respondents to a survey by the Michigan Health and Hospital Association Keystone Center. One-third of respondents indicated that they would extubate a patient receiving vasopressors, and one-quarter indicated that it depended on the agent used, but more than half reported that their unit did not have a vasopressor use protocol or they did not know whether it did. Practices regarding extubation of patients receiving vasopressor therapy differed significantly by unit type and by role as a direct care provider. These data indicate that patient and clinician factors may drive practice patterns. Additional research to inform guidelines and local protocols is warranted.

Using the Opportunity Estimator tool to improve engagement in a quality and safety intervention.

Teams throughout the United States participating in a program to reduce central line-associated bloodstream infections (CLABSIs) are using the Opportunity Estimator. This web-based tool translates CLABSI-related data into "opportunity estimates" of the patient lives and money that could be saved by reducing these infections.

Supply-Side Cost-Effectiveness Thresholds: Questions for Evidence-Based Policy.

There is growing interest in cost-effectiveness thresholds as a tool to inform resource allocation decisions in health care. Studies from several countries have sought to estimate health system opportunity costs, which supply-side cost-effectiveness thresholds are intended to represent. In this paper, we consider the role of empirical estimates of supply-side thresholds in policy-making. Recent studies estimate the cost per unit of health based on average displacement or outcome elasticity. We distinguish the types of point estimates reported in empirical work, including marginal productivity, average displacement, and outcome elasticity. Using this classification, we summarise the limitations of current approaches to threshold estimation in terms of theory, methods, and data. We highlight the questions that arise from alternative interpretations of thresholds and provide recommendations to policymakers seeking to use a supply-side threshold where the evidence base is emerging or incomplete. We recommend that: (1) policymakers must clearly define the scope of the application of a threshold, and the theoretical basis for empirical estimates should be consistent with that scope; (2) a process for the assessment of new evidence and for determining changes in the threshold to be applied in policy-making should be created; (3) decision-making processes should retain flexibility in the application of a threshold; and (4) policymakers should provide support for decision-makers relating to the use of thresholds and the implementation of decisions stemming from their application.

Assessing and improving safety climate in a large cohort of intensive care units.

OBJECTIVES: To evaluate the impact of a comprehensive unit-based safety program on safety climate in a large cohort of intensive care units participating in the Keystone intensive care unit project. DESIGN/SETTING: A prospective cohort collaborative study to improve quality of care and safety culture by implementing and evaluating patient safety interventions in intensive care units predominantly in the state of Michigan. INTERVENTIONS: The comprehensive unit-based safety program was the first intervention implemented by every intensive care unit participating in the collaborative. It is specifically designed to improve the various elements of a unit's safety culture, such as teamwork and safety climate. We administered the validated Safety Attitudes Questionnaire at baseline (2004) and after 2 yrs of exposure to the safety program (2006) to assess improvement. The safety climate domain on the survey includes seven items. MEASUREMENTS AND MAIN RESULTS: Post-safety climate scores for intensive care units. To interpret results, a score of <60% was in the "needs improvement" zone and a ≥10-point discrepancy in pre-post scores was needed to describe a difference. Hospital bed size, teaching status, and faith-based status were included in our analyses. Seventy-one intensive care units returned surveys in 2004 and 2006 with 71% and 73% response rates, respectively. Overall mean safety climate scores significantly improved from 42.5% (2004) to 52.2% (2006), t = -6.21, p < .001, with scores higher in faith-based intensive care units and smaller-bed-size hospitals. In 2004, 87% of intensive care units were in the "needs improvement" range and in 2006, 47% were in this range or did not score ≥10 points or higher. Five of seven safety climate items significantly improved from 2004 to 2006. CONCLUSIONS: A patient safety program designed to improve teamwork and culture was associated with significant improvements in overall mean safety climate scores in a large cohort of 71 intensive care units. Research linking improved climate scores and clinical outcomes is a critical next step.

Michigan Health & Hospital Association Keystone Obstetrics: a statewide collaborative for perinatal patient safety in Michigan.

BACKGROUND: Preventable harm to mothers and infants during labor and birth is a significant patient safety and professional liability issue. A Michigan Health & Hospital Association Keystone Center for Patient Safety & Quality Obstetric Collaborative Project involved perinatal teams from 15 Michigan hospitals during an 11-month period in 2009. The purpose of the project was to promote safe care practices during labor and birth using the Comprehensive Unit-based Safety Program (CUSP). Consistent with the CUSP model, this project's components included assessing and promoting a culture of safety; interdisciplinary team building; case review; learning from defects through multiple methods of education; team and individual coaching and peer encouragement; administrative support for the establishment of a fundamental safety infrastructure; and ongoing evaluation of care processes and outcomes. METHODS: Study measures included 32 components of a perinatal patient infrastructure, 6 care processes during labor and birth, and 4 neonatal outcomes. RESULTS: Significant improvements were found in the safety culture (Safety Attitudes Questionnaire), the perinatal patient safety infrastructure components, and all care processes. CONCLUSIONS: Although the project was successful, getting buy-in from all members of the clinical team in each hospital for all of the measures was challenging at times. There was initial resistance to some of the measures and their various expected aspects of care. For example, some of the clinicians were initially reluctant to adopt the recommended standardized oxytocin protocol. Peer encouragement and unit-based feedback on progress in minimizing early elective births proved useful in many hospitals. A CUSP in obstetrics can be beneficial in improving the care of mothers and infants during labor and birth.

Potential Destructive Binaural Interaction Effects in Auditory Steady-State Response Measurements.

An aided sound-field auditory steady-state response (ASSR) has the potential to be used to objectively validate hearing-aid (HA) fittings in clinics. Each aided ear should ideally be tested independently, but it is suspected that binaural testing may be used by clinics to reduce test time. This study simulates dichotic ASSR sound-field conditions to examine the risk of making false judgments due to unchecked binaural effects. Unaided ASSRs were recorded with a clinical two-channel electroencephalography (EEG) system for 15 normal hearing subjects using a three-band CE-Chirp® stimulus. It was found that the noise corrected power of a response harmonic can be suppressed by up to 10 dB by introducing large interaural time differences equal to half the time period of the stimulus envelope, which may occur in unilateral HA users. These large interaural time differences also changed the expression of ASSR power across the scalp, resulting in dramatically altered topographies. This would lead to considerably lower measured response power and possibly nondetections, evidencing that even well fit HAs are fit poorly (false referral), whereas monaural ASSR tests would pass. No effect was found for simulated lateralizations of the stimulus, which is beneficial for a proposed aided ASSR approach. Full-scalp ASSR recordings match previously found 40 Hz topographies but demonstrate suppression of cortical ASSR sources when using stimuli in interaural envelope antiphase.

Organizational Characteristics Associated With ICU Liberation (ABCDEF) Bundle Implementation by Adult ICUs in Michigan.

The ICU Liberation (ABCDEF) Bundle can help to improve care and outcomes for ICU patients, but bundle implementation is far from universal. Understanding how ICU organizational characteristics influence bundle implementation could inform quality improvement efforts. We surveyed all hospitals in Michigan with adult ICUs to determine whether organizational characteristics were associated with bundle implementation and to determine the level of agreement between ICU physician and nurse leaders around ICU organizational characteristics and bundle implementation. DESIGN: We surveyed ICU physician and nurse leaders, assessing their safety culture, ICU team collaboration, and work environment. Using logistic and linear regression models, we compared these organizational characteristics to bundle element implementation, and also compared physician and nurse leaders' perceptions about organizational characteristics and bundle implementation. SETTING: All (n = 72) acute care hospitals with adult ICUs in Michigan. SUBJECTS: ICU physician and nurse leader pairs from each hospital's main ICU. INTERVENTIONS: We developed, pilot-tested, and deployed an electronic survey to all subjects over a 3 month period in 2016. RESULTS: Results from 73 surveys (28 physicians, 45 nurses, 60% hospital response rate) demonstrated significant variation in hospital and ICU size and type, organizational characteristics, and physician/nurse perceptions of ICU organization and bundle implementation. We found that a robust safety culture and collaborative work environment that uses checklists to facilitate team communication are strongly associated with bundle implementation. There is also a significant dose-response effect between safety culture, a collaborative work environment, and overall bundle implementation. CONCLUSIONS: We identified several specific ICU practices that can facilitate ABCDEF Bundle implementation. Our results can be used to develop effective bundle implementation strategies that leverage safety culture, interprofessional collaboration, and routine checklist use in ICUs to improve bundle implementation and performance.

Improving data quality control in quality improvement projects.

BACKGROUND: The results of many quality improvement (QI) projects are gaining wide-spread attention. Policy-makers, hospital leaders and clinicians make important decisions based on the assumption that QI project results are accurate. However, compared with clinical research, QI projects are typically conducted with substantially fewer resources, potentially impacting data quality. Our objective was to provide a primer on basic data quality control methods appropriate for QI efforts. METHODS: Data quality control methods should be applied throughout all phases of a QI project. In the design phase, project aims should guide data collection decisions, emphasizing quality (rather than quantity) of data and considering resource limitations. In the data collection phase, standardized data collection forms, comprehensive staff training and a well-designed database can help maximize the quality of the data. Clearly defined data elements, quality assurance reviews of both collection and entry and system-based controls reduce the likelihood of error. In the data management phase, missing data should be quickly identified and corrected with system-based controls to minimize the missing data. Finally, in the data analysis phase, appropriate statistical methods and sensitivity analysis aid in managing and understanding the effects of missing data and outliers, in addressing potential confounders and in conveying the precision of results. CONCLUSION: Data quality control is essential to ensure the integrity of results from QI projects. Feasible methods are available and important to help ensure that stakeholder's decisions are based on accurate data.

Translating health care-associated urinary tract infection prevention research into practice via the bladder bundle.

BACKGROUND: Catheter-associated urinary tract infection (CAUTI), a frequent health care-associated infection (HAI), is a costly and common condition resulting in patient discomfort, activity restriction, and hospital discharge delays. The Centers for Medicare & Medicaid Services (CMS) no longer reimburses hospitals for the extra cost of caring for patients who develop CAUTI. The Michigan Health and Hospital Association (MHA) Keystone Center for Patient Safety & Quality has initiated a statewide initiative, MHA Keystone HAI, to help ameliorate the burden of disease associated with indwelling catheterization. In addition, a long-term research project is being conducted to evaluate the current initiative and to identify practical strategies to ensure the effective use of proven infection prevention and patient safety practices. OVERVIEW OF THE BLADDER BUNDLE INITIATIVE IN MICHIGAN: The bladder bundle as conceived by MHA Keystone HAI focuses on preventing CAUTI by optimizing the use of urinary catheters with a specific emphasis on continual assessment and catheter removal as soon as possible, especially for patients without a clear indication. COLLABORATION BETWEEN RESEARChERS AND STATE WIDE PATIENT SAFETY ORGANIZATIONS: A synergistic collaboration between patient safety researchers and a statewide patient safety organization is aimed at identifying effective strategies to move evidence from peer-reviewed literature to the bedside. Practical strategies that facilitate implementation of the bundle will be developed and tested using mixed quantitative and qualitative methods. DISCUSSION: Simply disseminating scientific evidence is often ineffective in changing clinical practice. Therefore, learning how to implement these findings is critically important to promoting high-quality care and a safe health care environment.