Effect of Chlorhexidine Bathing Every Other Day on Prevention of Hospital-Acquired Infections in the Surgical ICU: A Single-Center, Randomized Controlled Trial.

OBJECTIVE: To test the hypothesis that compared with daily soap and water bathing, 2% chlorhexidine gluconate bathing every other day for up to 28 days decreases the risk of hospital-acquired catheter-associated urinary tract infection, ventilator-associated pneumonia, incisional surgical site infection, and primary bloodstream infection in surgical ICU patients. DESIGN: This was a single-center, pragmatic, randomized trial. Patients and clinicians were aware of treatment-group assignment; investigators who determined outcomes were blinded. SETTING: Twenty-four-bed surgical ICU at a quaternary academic medical center. PATIENTS: Adults admitted to the surgical ICU from July 2012 to May 2013 with an anticipated surgical ICU stay for 48 hours or more were included. INTERVENTIONS: Patients were randomized to bathing with 2% chlorhexidine every other day alternating with soap and water every other day (treatment arm) or to bathing with soap and water daily (control arm). MEASUREMENTS AND MAIN RESULTS: The primary endpoint was a composite outcome of catheter-associated urinary tract infection, ventilator-associated pneumonia, incisional surgical site infection, and primary bloodstream infection. Of 350 patients randomized, 24 were excluded due to prior enrollment in this trial and one withdrew consent. Therefore, 325 were analyzed (164 soap and water versus 161 chlorhexidine). Patients acquired 53 infections. Compared with soap and water bathing, chlorhexidine bathing every other day decreased the risk of acquiring infections (hazard ratio = 0.555; 95% CI, 0.309-0.997; p = 0.049). For patients bathed with soap and water versus chlorhexidine, counts of incident hospital-acquired infections were 14 versus 7 for catheter-associated urinary tract infection, 13 versus 8 for ventilator-associated pneumonia, 6 versus 3 for incisional surgical site infections, and 2 versus 0 for primary bloodstream infection; the effect was consistent across all infections. The absolute risk reduction for acquiring a hospital-acquired infection was 9.0% (95% CI, 1.5-16.4%; p = 0.019). Incidences of adverse skin occurrences were similar (18.9% soap and water vs 18.6% chlorhexidine; p = 0.95). CONCLUSIONS: Compared with soap and water, chlorhexidine bathing every other day decreased the risk of acquiring infections by 44.5% in surgical ICU patients.

Outcomes and Resource Use of Sepsis-associated Stays by Presence on Admission, Severity, and Hospital Type.

OBJECTIVE: To establish a baseline for the incidence of sepsis by severity and presence on admission in acute care hospital settings before implementation of a broad sepsis screening and response initiative. METHODS: A retrospective cohort study using hospital discharge abstracts of 5672 patients, aged 18 years and above, with sepsis-associated stays between February 2012 and January 2013 at an academic medical center and 5 community hospitals in Texas. RESULTS: Sepsis was present on admission in almost 85% of cases and acquired in-hospital in the remainder. The overall inpatient death rate was 17.2%, but was higher in hospital-acquired sepsis (38.6%, medical; 29.2%, surgical) and Stages 2 (17.6%) and 3 (36.4%) compared with Stage 1 (5.9%). Patients treated at the academic medical center had a higher death rate (22.5% vs. 15.1%, P<0.001) and were more costly ($68,050±184,541 vs. $19,498±31,506, P<0.001) versus community hospitals. CONCLUSIONS: Greater emphasis is needed on public awareness of sepsis and the detection of sepsis in the prehospitalization and early hospitalization period. Hospital characteristics and case mix should be accounted for in cross-hospital comparisons of sepsis outcomes and costs.

Surgeon-Specific Reports in General Surgery: Establishing Benchmarks for Peer Comparison Within a Single Hospital.

BACKGROUND: Methods to assess a surgeon's individual performance based on clinically meaningful outcomes have not been fully developed, due to small numbers of adverse outcomes and wide variation in case volumes. The Achievable Benchmark of Care (ABC) method addresses these issues by identifying benchmark-setting surgeons with high levels of performance and greater case volumes. This method was used to help surgeons compare their surgical practice to that of their peers by using merged National Surgical Quality Improvement Program (NSQIP) and Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) data to generate surgeon-specific reports. STUDY DESIGN: A retrospective cohort study at a single institution's department of surgery was conducted involving 107 surgeons (8,660 cases) over 5.5 years. Stratification of more than 32,000 CPT codes into 16 CPT clusters served as the risk adjustment. Thirty-day outcomes of interest included surgical site infection (SSI), acute kidney injury (AKI), and mortality. Performance characteristics of the ABC method were explored by examining how many surgeons were identified as benchmark-setters in view of volume and outcome rates within CPT clusters. RESULTS: For the data captured, most surgeons performed cases spanning a median of 5 CPT clusters (range 1 to 15 clusters), with a median of 26 cases (range 1 to 776 cases) and a median of 2.8 years (range 0 to 5.5 years). The highest volume surgeon for that CPT cluster set the benchmark for 6 of 16 CPT clusters for SSIs, 8 of 16 CPT clusters for AKIs, and 9 of 16 CPT clusters for mortality. CONCLUSIONS: The ABC method appears to be a sound and useful approach to identifying benchmark-setting surgeons within a single institution. Such surgeons may be able to help their peers improve their performance.

Optimizing Evaluation of Patients with Low-to-Intermediate-Risk Acute Chest Pain: A Randomized Study Comparing Stress Myocardial Perfusion Tomography Incorporating Stress-Only Imaging Versus Cardiac CT.

UNLABELLED: The purpose of this study was to determine whether stress myocardial perfusion (SPECT) optimized with stress-only (SO) imaging is comparable to cardiac CT angiography (CTA) for evaluating patients with acute chest pain (ACP). METHODS: This was a prospective randomized observational study in 598 ACP patients who underwent CTA versus SPECT. The primary endpoint was length of hospital stay, and secondary endpoints were test feasibility, time to diagnosis, diagnostic accuracy, radiation exposure, and overall cost. Median follow-up was 6.5 mo, with a 3.8% cardiac event rate defined as death or an acute coronary syndrome. RESULTS: Of 2,994 patients screened, 1,703 (56.9%) were not candidates for CTA because of prior cardiac disease (41%) or imaging contraindications (16%). Time to diagnosis (8.1 ± 8.5 vs. 9.4 ± 7.4 h) and length of hospital stay (19.7 ± 27.8 vs. 23.5 ± 34.4 h) were significantly shorter with CTA than with SPECT (P = 0.002). However, time to diagnosis (7.0 ± 6.2 vs. 6.8 ± 5.9 h, P = 0.20), length of stay (15.5 ± 17.2 vs. 16.7 ± 15.3 h, P = 0.36), and hospital costs ($4,242 ± $3,871 vs. $4,364 ± 1781, P = 0.86) were comparable with CTA versus SO SPECT, respectively. SO was also superior to conventional SPECT regarding all of the above metrics and significantly reduced radiation exposure (5.5 ± 4.4 vs. 12.5 ± 2.7 mSv, P < 0.0001). CONCLUSION: Stress SPECT when optimized with SO imaging is similar to CTA in time to diagnosis, length of hospital stay, and cost, with improved prognostic accuracy and less radiation exposure. Our results emphasize the importance of SO imaging, particularly in low-intermediate-risk emergency room patients who are a population likely to have a normal test result.

Reductions in Sepsis Mortality and Costs After Design and Implementation of a Nurse-Based Early Recognition and Response Program.

BACKGROUND: Sepsis is a leading cause of death, but evidence suggests that early recognition and prompt intervention can save lives. In 2005 Houston Methodist Hospital prioritized sepsis detection and management in its ICU. In late 2007, because of marginal effects on sepsis death rates, the focus shifted to designing a program that would be readily used by nurses and ensure early recognition of patients showing signs suspicious for sepsis, as well as the institution of prompt, evidence-based interventions to diagnose and treat it. METHODS: The intervention had four components: organizational commitment and data-based leadership; development and integration of an early sepsis screening tool into the electronic health record; creation of screening and response protocols; and education and training of nurses. Twice-daily screening of patients on targeted units was conducted by bedside nurses; nurse practitioners initiated definitive treatment as indicated. Evaluation focused on extent of implementation, trends in inpatient mortality, and, for Medicare beneficiaries, a before-after (2008-2011) comparison of outcomes and costs. A federal grant in 2012 enabled expansion of the program. RESULTS: By year 3 (2011) 33% of inpatients were screened (56,190 screens in 9,718 unique patients), up from 10% in year 1 (2009). Inpatient sepsis-associated death rates decreased from 29.7% in the preimplementation period (2006-2008) to 21.1% after implementation (2009-2014). Death rates and hospital costs for Medicare beneficiaries decreased from preimplementation levels without a compensatory increase in discharges to postacute care. CONCLUSION: This program has been associated with lower inpatient death rates and costs. Further testing of the robustness and exportability of the program is under way.

Systematic review of observational studies reveals no association between low back pain and lumbar spondylolysis with or without isthmic spondylolisthesis.

PURPOSE: The hypothesis that spondylolysis (SL) and/or isthmic spondylolisthesis (IS) cause low back pain (LBP) is widely accepted representing surgical indication in symptomatic cases. If SL/IS cause LBP, individuals with these conditions should be more prone to LBP than those without SL/IS. Therefore, the goal of the study was to assess whether the published primary data demonstrate an association between SL/IS and LBP in the general adult population. METHODS: Systematic review of published observational studies to identify any association between SL/IS and LBP in adults. The methodological quality of the cohort and case-control studies was evaluated using the Newcastle-Ottawa scale. RESULTS: Fifteen studies met inclusion criteria (one cohort, seven case-control, seven cross-sectional). Neither the cohort study nor the two highest-quality case-control studies detected an association between SL/IS and LBP; the same is true for the remaining studies. CONCLUSIONS: There is no strong or consistent association between SL/IS and LBP in epidemiological studies of the general adult population that would support a hypothesis of causation. It is possible that SL/IS coexist with LBP, and observed effects of surgery and other treatment modalities are primarily due to benign natural history and nonspecific treatment effects. We conclude that traditional surgical practice for the adult general population, in which SL/IS is assumed to be the cause of non-radicular LBP whenever the two coexist, should be reconsidered in light of epidemiological data accumulated in recent decades.

Surgeon-specific performance reports in general surgery: an observational study of initial implementation and adoption.

BACKGROUND: As national quality initiatives are increasing requirements for individual physician data, our department of surgery initiated a surgeon-specific reporting (SSR) program to assess the value of personal knowledge on individual performance quality. We sought to evaluate the use of SSR as a tool to enable surgeons to assess and improve their clinical performance, and to identify barriers to use of their reports. STUDY DESIGN: Qualitative research design involving semistructured interviews of surgeons who received performance reports derived from National Surgical Quality Improvement Program (NSQIP), Surgical Care Improvement Project (SCIP), and the Centers for Medicare and Medicaid Services (CMS) core measures and hospital administrative data. Transcripts were analyzed by the constant comparative method. RESULTS: Twenty-four of 39 surgeons (61.5%) who received their SSRs agreed to be interviewed and 23 were interviewed. About half (11 of 23) demonstrated comprehension of the data validity, accuracy, or complexity. Of these, 6 took steps to validate data or improve performance. Most respondents believed SSR would lead to performance improvement through knowledge of personal outcomes and peer comparison; however, they perceived SSR had limitations, such as small sample size and potential coding errors, and could lead to unintended consequences, such as inaccurate interpretation by others and surgeons' aversion to selecting high-risk patients. Respondents also suggested logistical improvements to reporting methods, such as report format and definitions of metrics. CONCLUSIONS: Surgeon-specific reporting has the potential to empower surgeons to improve their practice; however, more surgeons need efficient guidelines to understand the metrics. Our findings can be used to guide development of more SSR programs. Whether SSR programs lead to improvements in surgical outcomes is a matter for future research.

Are surgical trials with negative results being interpreted correctly?

BACKGROUND: Many published accounts of clinical trials report no differences between the treatment arms, while being underpowered to find differences. This study determined how the authors of these reports interpreted their findings. STUDY DESIGN: We examined 54 reports of surgical trials chosen randomly from a database of 110 influential trials conducted in 2008. Seven that reported having adequate statistical power (ß ≥ 0.9) were excluded from further analysis, as were the 32 that reported significant differences between the treatment arms. We examined the remaining 15 to see whether the authors interpreted their negative findings appropriately. Appropriate interpretations discussed the lack of power and/or called for larger studies. RESULTS: Three of the 7 trials that did not report an a priori power calculation offered inappropriate interpretations, as did 3 of the 8 trials that reported an a priori power < 0.90. However, we examined only a modest number of trial reports from 1 year. CONCLUSIONS: Negative findings in underpowered trials were often interpreted as showing the equivalence of the treatment arms with no discussion of the issue of being underpowered. This may lead clinicians to accept new treatments that have not been validated.

Trials and tribulations: the professional development of surgical trialists.

BACKGROUND: Regulatory and professional bodies issue an ever-increasing number of guidance documents on the ethics and methods of clinical trials, but the quality of clinical trials of invasive therapeutic procedures continues to be a concern. We interviewed aspiring and accomplished surgical trialists to understand how they use guidance documents and other resources in their work. METHODS: We performed a qualitative research study involving semistructured interviews of a diverse sample of 15 surgical trialists. RESULTS: Professional development as a surgical trialist was haphazard, inefficient, and marked by avoidable mistakes. Four types of resources played constructive roles: formal education; written materials on clinical trials; experience with actual trials; and interpersonal interactions with peers, experts, collaborators, and mentors. Recommendations for improvement centered on education, mentoring, networking, participating in trials, and facilitation by department chairs. CONCLUSIONS: The haphazard and unstructured nature of the current system is adding unnecessarily to the numerous challenges faced by surgical trialists.

Conflicts among multinational ethical and scientific standards for clinical trials of therapeutic interventions.

Utilizing a sorted compendium of international clinical trial standards, investigators identified 15 conflicts among ethical and methodological guidance. Analysis distinguishes interpretational issues, lack of clarity, and contradiction as factors to be addressed if international trial guidance is to be improved.

Comparative effectiveness of individual angiotensin receptor blockers on risk of mortality in patients with chronic heart failure.

OBJECTIVE: There is little evidence on comparative effectiveness of individual angiotensin receptor blockers (ARBs) in patients with chronic heart failure (CHF). This study compared four ARBs in reducing risk of mortality in clinical practice. METHODS: A retrospective analysis was conducted on a national sample of patients diagnosed with CHF from 1 October 1996 to 30 September 2002 identified from Veterans Affairs electronic medical records, with supplemental clinical data obtained from chart review. After excluding patients with exposure to ARBs within the previous 6 months, four treatment groups were defined based on initial use of candesartan, valsartan, losartan, and irbesartan between the index date (1 October 2000) and the study end date (30 September 2002). Time to death was measured concurrently during that period. A marginal structural model controlled for sociodemographic factors, comorbidities, comedications, disease severity (left ventricular ejection fraction), and potential time-varying confounding affected by previous treatment (hospitalization). Propensity scores derived from a multinomial logistic regression were used as inverse probability of treatment weights in a generalized estimating equation to estimate causal effects. RESULTS: Among the 1536 patients identified on ARB therapy, irbesartan was most frequently used (55.21%), followed by losartan (21.74%), candesartan (15.23%), and valsartan (7.81%). When compared with losartan, after adjusting for time-varying hospitalization in marginal structural model, candesartan (OR = 0.79, 95%CI = 0.42-1.50), irbesartan (OR = 1.17, 95%CI = 0.72-1.90), and valsartan (OR = 0.98, 95%CI = 0.45-2.14) were found to have similar effectiveness in reducing mortality in CHF patients. CONCLUSION: Effectiveness of ARBs in reducing mortality is similar in patients with CHF in everyday clinical practice.

A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions.

BACKGROUND: If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. METHODS: The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as 'core', 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. FINDINGS: Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. CONCLUSIONS: The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research.

A patient self-assessment tool to measure communication behaviors during doctor visits about hypertension.

OBJECTIVE: To develop a preliminary version of a post-doctor visit self-assessment tool that patients with hypertension can use to evaluate their communication behaviors. High-quality communication between patient and doctor may have a positive effect on blood pressure control in hypertensive patients. Patients' communicative behaviors such as asking questions influence those of doctors, but most existing measurement tools assess doctors' behaviors rather than patients'. METHODS: The tool is intended for use by African American or Caucasian American adults with hypertension, regardless of literacy level. The project included theory-based development of the item pool, usability testing (8 individuals), and cognitive response testing (13 additional individuals). MAIN RESULTS: After multiple iterations, the preliminary version includes 138 items in 7 theory-based domains. CONCLUSION AND PRACTICE IMPLICATIONS: The self-assessment tool is ready for testing of item and scale reliability and validity and consequent item reduction. This tool could prove useful in trials evaluating whether patients with hypertension who learn to be better communicators are more likely to achieve blood pressure control. In addition, because it asks patients to reflect on their use of specific behaviors that can be learned, the tool might also help patients in clinical practice to assume more active roles during their medical interactions.

A stories-based interactive DVD intended to help people with hypertension achieve blood pressure control through improved communication with their doctors.

OBJECTIVE: Our goal was to develop an interactive DVD to help African American and Caucasian American adults with hypertension learn how to become better communicators during medical interactions. Material was to be presented in several formats, including patients' narratives (stories). METHODS: To develop the narratives we recruited members of the target audience and elicited stories and story units in focus groups, interviews, and seminars. Story units were ranked-ordered based on conformance with the theory of planned behavior and narrative qualities and then melded into cohesive stories. The stories were recounted by actors on the DVD. RESULTS: 55 adults (84% women; 93% African American) participated in a focus group, interview, or seminar; transcripts yielded 120 story units. The most highly rated units were woven into 11 stories. The six highest rated stories/actor-storytellers were selected for presentation on the DVD. CONCLUSION: We achieved our goal of developing an easy-to-use, story-driven product that may teach adults how to talk effectively with their doctors about hypertension. The DVD's effectiveness should be tested in a randomized trial. PRACTICE IMPLICATIONS: Behavioral interventions aimed at improving patients' ability to communicate during doctor visits may be useful adjuncts in the achievement of BP goals.

Overcoming limits to tobacco control: using the Internet to bridge clinical and public health interventions.

Links between clinical and public health interventions are limited. Using the Internet as a delivery method provides the potential to link multiple intervention components, but this potential has not yet been realized. In this poster, we present results of a formative assessment to identify approaches to improving clinical-public health linkages.

A randomized trial of self-management and psychoeducational group therapies for comorbid chronic posttraumatic stress disorder and depressive disorder.

The authors randomized 101 male veterans with chronic combat-related posttraumatic stress disorder (PTSD) and depressive disorder to an evidence-based depression treatment (self-management therapy; n = 51) or active-control therapy (n = 50). Main outcome measures for efficacy, using intention-to-treat analyses, were subjective and objective PTSD and depression scales at pretest, posttest, and 3-, 6-, and 12-month follow-up. Other measures included treatment compliance, satisfaction, treatment-targeted constructs, functioning, service utilization, and costs. Self-management therapy's modestly greater improvement on depression symptoms at treatment completion disappeared on follow-up. No other differences on symptoms or functioning appeared, although psychiatric outpatient utilization and overall outpatient costs were lower with self-management therapy. Despite success in other depressed populations, self-management therapy produced no clinically significant effect in depression with chronic PTSD.

Process of care and outcomes in patients with peripheral arterial disease.

BACKGROUND: We investigated the association of process of care measures with adverse limb and systemic events in patients with peripheral arterial disease (PAD). METHODS: We conducted a retrospective cohort study of patients with PAD, as defined by an ankle-brachial index (ABI) <0.9. The index date was defined as the date, during 1995 to 1998, when the patient was seen in the Michael E. DeBakey VA Medical Center noninvasive vascular laboratory and found to have PAD. We conducted a chart review for process of care variables starting 3 years before the index date and ending at the time of the first event or the final visit (December 31, 2001), whichever occurred first. We examined the association between PAD process of care measures, including risk factor control, and prescribing of medication, with time of the patient's first major limb event or death. RESULTS: Of the 796 patients (mean age, 65 +/- 9.9 years), 230 (28.9% experienced an adverse limb event (136 lower-extremity bypass, 94 lower-extremity amputation), and 354 (44.5%) died. Of the patients who died, 247 died without a preceding limb event. Glucose control was protective against death or a limb event with a hazard ratio (HR) of 0.74 (95% confidence limits [CL] 0.60, 0.91, P = 0.004). African Americans were at 2.8 (95% CL 1.7, 4.5) times the risk of Whites or Hispanics for an adverse limb event. However, this risk was no longer significant if their glucose was controlled. For process measures, the dispensing of PAD specific medication (HR 1.4, 95% CL 1.1, 1.7) was associated an increased risk for an adverse outcome. CONCLUSIONS: Our data suggest that glucose control is key to reducing the risk for adverse outcomes, particularly limb events in African Americans. Certain process of care measures, as markers of disease severity and disease management, are associated with poor outcomes in patients with PAD. Further work is needed to determine the role of early disease intervention to reduce poor outcomes in patients with PAD.

A quasi-experimental test of an intervention to increase the use of thiazide-based treatment regimens for people with hypertension.

BACKGROUND: Despite recent high-quality evidence for their cost-effectiveness, thiazides are underused for controlling hypertension. The goal of this study was to design and test a practice-based intervention aimed at increasing the use of thiazide-based antihypertensive regimens. METHODS: This quasi-experimental study was carried out in general medicine ambulatory practices of a large, academically-affiliated Veterans Affairs hospital. The intervention group consisted of the practitioners (13 staff and 215 trainees), nurses, and patients (3,502) of the teaching practice; non-randomized concurrent controls were the practitioners (31 providers) and patients (18,292) of the non-teaching practices. Design of the implementation intervention was based on Rogers' Diffusion of Innovations model. Over 10.5 months, intervention teams met weekly or biweekly and developed and disseminated informational materials among themselves and to trainees, patients, and administrators. These teams also reviewed summary electronic-medical-record data on thiazide use and blood pressure (BP) goal attainment. Outcome measures were the proportion of hypertensive patients prescribed a thiazide-based regimen, and the proportion of hypertensive patients attaining BP goals regardless of regimen. Thirty-three months of time-series data were available; statistical process control charts, change point analyses, and before-after analyses were used to estimate the intervention's effects. RESULTS: Baseline use of thiazides and rates of BP control were higher in the intervention group than controls. During the intervention, thiazide use and BP control increased in both groups, but changes occurred earlier in the intervention group, and primary change points were observed only in the intervention group. Overall, the pre-post intervention difference in proportion of patients prescribed thiazides was greater in intervention patients (0.091 vs. 0.058; p = 0.0092), as was the proportion achieving BP goals (0.092 vs. 0.044; p = 0.0005). At the end of the implementation period, 41.4% of intervention patients were prescribed thiazides vs. 30.6% of controls (p < 0.001); 51.6% of intervention patients had achieved BP goals vs. 44.3% of controls (p < 0.001). CONCLUSION: This multi-faceted intervention appears to have resulted in modest improvements in thiazide prescribing and BP control. The study also demonstrates the value of electronic medical records for implementation research, how Rogers' model can be used to design and launch an implementation strategy, and how all members of a clinical microsystem can be involved in an implementation effort.