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.

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.

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.

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.

Racial and ethnic differences in the treatment of seriously ill patients: a comparison of African-American, Caucasian and Hispanic veterans.

BACKGROUND: No national data exist regarding racial/ethnic differences in the use of interventions for patients at the end of life. OBJECTIVES: To test whether among 3 cohorts of hospitalized seriously ill veterans with cancer, noncancer or dementia the use of common life-sustaining treatments differed significantly by race/ethnicity. DESIGN: Retrospective cohort study during fiscal years 1991-2002. PATIENTS: Hospitalized veterans >55 years, defined clinically as at high-risk for 6-month mortality, not by decedent data. MEASUREMENTS: Utilization patterns by race/ethnicity for 5 life-sustaining therapies. Logistic regression models evaluated differences among Caucasians, African Americans and Hispanics, controlling for age, disease severity and clustering of patients within Veterans Affairs (VA) medical centers. RESULTS: Among 166,059 veterans, both differences and commonalities across diagnostic cohorts were found. African Americans received more or the same amount of end-of-life treatments across disease cohorts, except for less resuscitation [OR = 0.84 (0.77-0.92), p = 0.002] and mechanical ventilation [OR = 0.89 (0.85-0.94), p < or = 0.0001] in noncancer patients. Hispanics were 36% (cancer) to 55% (noncancer) to 88% (dementia) more likely to receive transfusions than Caucasians (p < 0.0001). They received similar rates as Caucasians for all other interventions in all other groups, except for 161% higher likelihood for mechanical ventilation in patients with dementia. Increased end-of-life treatments for both minority groups were most pronounced in the dementia cohort. Differences demonstrated a strong interaction with the disease cohort. CONCLUSIONS: Differences in level of end-of-life treatments were disease specific and bidirectional for African Americans. In the absence of generally accepted, evidence-based standards for end-of-life care, these differences may or may not constitute disparities.

Hospital use and survival among Veterans Affairs beneficiaries.

BACKGROUND: Initiatives to reduce hospital care were part of the reorganization of the Department of Veterans Affairs (VA) medical care system undertaken in the mid-1990s. We examined changes in the use of VA health services and survival from 1994 through 1998 among VA beneficiaries with serious chronic diseases. We postulated that if access to hospital care was reduced too much, or if decreased hospital use was not offset by improvements in ambulatory care, urgent care visits would increase or survival rates would fall. METHODS: We tracked changes in risk-adjusted VA bed-day rates, rates of medical visits, rates of visits for testing and consultation, and rates of urgent care visits per patient-year among VA beneficiaries in nine disease cohorts (a total of 342,300 beneficiaries). Trends in non-VA hospital use by VA beneficiaries 65 years of age or older who were enrolled in fee-for-service Medicare were also studied. VA and Medicare vital-status data were used to calculate one-year survival rates. RESULTS: From 1994 through 1998, VA bed-day rates fell by 50 percent, rates of medical-clinic visits and visits for testing and consultation increased moderately, and rates of urgent care visits fell by 35 percent. The sharp decline in the use of VA hospitals was not compensated for by increases in the use of Medicare-reimbursed non-VA hospital care by veterans eligible for both VA care and Medicare, and the use of non-VA hospitals actually declined in four cohorts. The survival rates were essentially unchanged over the study period. CONCLUSIONS: The marked decline in VA hospital use from 1994 through 1998 did not curtail access to needed services and was not associated with serious consequences for chronically ill VA beneficiaries.

A controlled trial of arthroscopic surgery for osteoarthritis of the knee.

BACKGROUND: Many patients report symptomatic relief after undergoing arthroscopy of the knee for osteoarthritis, but it is unclear how the procedure achieves this result. We conducted a randomized, placebo-controlled trial to evaluate the efficacy of arthroscopy for osteoarthritis of the knee. METHODS: A total of 180 patients with osteoarthritis of the knee were randomly assigned to receive arthroscopic débridement, arthroscopic lavage, or placebo surgery. Patients in the placebo group received skin incisions and underwent a simulated débridement without insertion of the arthroscope. Patients and assessors of outcome were blinded to the treatment-group assignment. Outcomes were assessed at multiple points over a 24-month period with the use of five self-reported scores--three on scales for pain and two on scales for function--and one objective test of walking and stair climbing. A total of 165 patients completed the trial. RESULTS: At no point did either of the intervention groups report less pain or better function than the placebo group. For example, mean (+/-SD) scores on the Knee-Specific Pain Scale (range, 0 to 100, with higher scores indicating more severe pain) were similar in the placebo, lavage, and débridement groups: 48.9+/-21.9, 54.8+/-19.8, and 51.7+/-22.4, respectively, at one year (P=0.14 for the comparison between placebo and lavage; P=0.51 for the comparison between placebo and débridement) and 51.6+/-23.7, 53.7+/-23.7, and 51.4+/-23.2, respectively, at two years (P=0.64 and P=0.96, respectively). Furthermore, the 95 percent confidence intervals for the differences between the placebo group and the intervention groups exclude any clinically meaningful difference. CONCLUSIONS: In this controlled trial involving patients with osteoarthritis of the knee, the outcomes after arthroscopic lavage or arthroscopic débridement were no better than those after a placebo procedure.

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.

Impact of race on health care utilization and outcomes in veterans with congestive heart failure.

OBJECTIVES: The objectives of this study were to determine racial differences in mortality in a national cohort of patients hospitalized with congestive heart failure (CHF) within a financially "equal-access" healthcare system, the Veterans Health Administration (VA), and to examine racial differences in patterns of healthcare utilization following hospitalization. BACKGROUND: To explain the observed paradox of increased readmissions and lower mortality in black patients hospitalized with CHF, it has been postulated that black patients may have reduced access to outpatient care, resulting in a higher number of hospital admissions for lesser disease severity. METHODS: In a retrospective study of 4,901 black and 17,093 white veterans hospitalized with CHF in 153 VA hospitals, we evaluated mortality at 30 days and 2 years, and healthcare utilization in the year following discharge. RESULTS: The risk-adjusted odds ratios (OR) for 30-day and 2-year mortality in black versus white patients were 0.70 (95% confidence interval [CI] 0.60 to 0.82) and 0.84 (95% CI 0.78 to 0.91), respectively. In the year following discharge, blacks had the same rate of readmissions as whites. Blacks had a lower rate of medical outpatient clinic visits and a higher rate of urgent care/emergency room visits than whites, although these differences were small. CONCLUSIONS: In a system where there is equal access to healthcare, the racial gap in patterns of healthcare utilization is small. The observation of better survival in black patients after a CHF hospitalization is not readily explained by differences in healthcare utilization.

Surprisingly high prevalence of anxiety and depression in chronic breathing disorders.

STUDY OBJECTIVES: The objectives of this study were to assess the prevalence, screening, and recognition of depression and anxiety in persons with chronic breathing disorders, including COPD. DESIGN: Cross-sectional study. SETTING: The Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC). PARTICIPANTS: A large sample of 1,334 persons with chronic breathing disorder diagnoses who received care at the MEDVAMC. MEASUREMENTS: The prevalence of anxiety and depression was measured in a large sample of persons with a chronic breathing disorder diagnosis who received care at the MEDVAMC, using the Primary Care Evaluation of Mental Disorders (PRIME-MD) screening questions. The positive predictive value of the PRIME-MD questions was then determined. The prevalence of anxiety and depressive diagnoses in patients determined to have COPD was then measured, using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID). RESULTS: Of patients screened with the PRIME-MD, 80% screened positive for depression, anxiety, or both. The predictive value of a positive phone screen for either depression or anxiety was estimated to be 80%. In the subsample of patients who had COPD and received a diagnosis using the SCID, 65% received an anxiety and/or depressive disorder diagnosis. Of those patients, only 31% were receiving treatment for depression and/or anxiety. CONCLUSIONS: It is troubling that a mere 31% of COPD patients with depression or anxiety are being treated, particularly given their high prevalence in this population. Practical screening instruments may help increase the recognition of anxiety and depression in medical patients, as suggested by the excellent positive predictive value of the PRIME-MD in our study.

Decreasing use of percutaneous endoscopic gastrostomy tube feeding for veterans with dementia-racial differences remain.

OBJECTIVES: Percutaneous endoscopic gastrostomy (PEG) tube placement is a widely used method for long-term enteral feeding of demented patients unable to take sufficient food by mouth. National time trends in PEG tube use over the last decade have not been previously reported. The objective of this study was to determine whether use of PEG tubes for patients with dementia has changed over time and by race. DESIGN: Retrospective cohort study. SETTING: All Veterans Affairs hospitals. PARTICIPANTS: Using an administrative database of the Veterans Health Administration, all veterans with dementia and all veterans who received a PEG tube were identified between fiscal years 1990-2001. MEASUREMENTS: Proportion of PEG tube placement for dementia patients over time and by race. RESULTS: Four hundred thirteen thousand six hundred twenty-seven dementia patients aged 60 and older were identified, of whom 6,464 (1.6%) received a PEG tube. Use of PEG tubes for dementia patients increased during the first half of the decade but subsequently decreased almost to baseline after peaking in 1996 (1990: 1.2%, 1996: 1.8%, 2001: 1.3%). Time trends in the use of PEG tube feeding for dementia patients varied by race. Specifically, the relative risk for PEG tube placement in African-American dementia patients increased from 1.65 (95% confidence interval (CI)=1.25-2.17, FY 1990) to 1.97 (95% CI=1.62-2.4, FY 2001). CONCLUSION: Although the overall use of PEG tube feeding for dementia patients decreased over time, rates in use and changes in use over time varied significantly by race. Reasons for the differential use of this procedure should be explored.

Physician-patient communication following invasive procedures: an analysis of post-angiogram consultations.

Although rarely studied, physician-patient interactions immediately following diagnostic tests are significant medical events because during these encounters the physician and patient often make decisions about major and sometimes invasive treatment. This investigation analyzed patterns of physician-patient communication following coronary angiography with particular attention to behaviors important to decision-making: physician information-giving, physician use of partnership-building, and active forms of patient participation (e.g., asking questions, being assertive, expressing concerns). We were particularly interested in effects related to the patient's race in light of documented evidence of racial disparities in cardiac care and outcomes. From audiotape recordings, 93 physician-patient interactions after coronary angiogram in a catheterization laboratory in a large US Veterans Affairs Medical Center were coded to measure the frequency of physicians' information-giving and partnership-building and the frequency of active patient participation. We also stratified these behaviors according to whether the behavior was prompted (e.g., physician information in response to a patient's question; a patient's opinion solicited by the doctor) or self-initiated. Several findings were noteworthy. First, these interactions were very brief and dominated by the physician. Second, although physician information-giving increased with more active patient participation, which in turn was correlated with physicians' use of partnership-building, proportionally little of the physicians' information (8%) and active patient participation (9%) was directly prompted by the other interactant. Finally, there was a tendency for physicians to self-initiate less information giving to black patients and for black patients to self-initiate less active participation than white patients. Although these differences were attenuated when other variables (e.g., the physician's training, disease severity) were included in the analysis, the pattern suggests a potential cycle of passivity where certain patients tend to receive fewer informational resources and these patients in turn do less to prompt the doctor for more.

Are anxiety and depression addressed in primary care patients with chronic obstructive pulmonary disease? A chart review.

OBJECTIVE: Screening for mental illness in primary care is widely recommended, but little is known about the evaluation, treatment, and long-term management processes that follow screening. The aim of this study was to examine and describe the quality of mental health care for persons with chronic obstructive pulmonary disease (COPD) and anxiety/depressive disorders, as measured by adherence to practice guidelines. METHOD: This retrospective chart review examined data for 102 primary care and mental health care patients with COPD who were diagnosed, using Structured Clinical Interview for DSM-IV criteria, with major depressive disorder, dysthymia, depression not otherwise specified, generalized anxiety disorder, or anxiety not otherwise specified. Data were gathered from primary care progress notes from the year prior to enrollment in a randomized controlled trial (enrollment was from July 2002 to April 2004). We compared the care received by these patients over 1 year with that recommended by practice guidelines. Charts were abstracted using a checklist of recommended practice guidelines for diagnostic evaluation, acute treatment, and long-term management of anxiety and depressive disorders. RESULTS: Fifty (49%) of the 102 patients were recognized during the review year as having an anxiety or depressive disorder. Eighteen patients were newly assessed for depressive or anxiety disorders during the chart review year. Patients followed in primary care alone, compared with those who were comanaged by mental health care providers, were less likely to have guideline-adherent care. CONCLUSION: Depressive and anxiety disorders are recognized in about half of patients; however, guideline-supported diagnostic evaluation, acute treatment (except for medications), and long-term management rarely occur in the primary care setting. To improve the treatment of depressive and anxiety disorders in primary care, the process of care delivery must be understood and changed.

Healthcare use by veterans treated for diabetes mellitus in the Veterans Affairs medical care system.

OBJECTIVES: To estimate the burden of comorbid conditions and to describe patterns of inpatient and outpatient service use by veterans with diabetes mellitus. STUDY DESIGN: Retrospective cohort study of 33,481 veterans conducted by means of secondary analysis of Department of Veterans Affairs (VA) healthcare utilization databases. PATIENTS AND METHODS: The cohort was constructed by enrolling all veterans treated in the VA medical care system who had their initial VA hospitalization for diabetes mellitus between 1992 and 1997. To estimate the typical annual pattern of service use for diabetes mellitus, 1997 utilization rates per person-year were analyzed based on cohort members surviving into 1997. Data on comorbid conditions were obtained from outpatient and inpatient contacts. RESULTS: The 3 most prevalent coexisting conditions were hypertension (73.4%), ischemic heart disease (35.2%), and alcohol or drug abuse disorders (29.5%). In 1997, the typical cohort member followed for 12 months had 6 primary care visits, 16 other visits for tests or consultations, and 1.3 unscheduled visits for emergency or urgent care and spent approximately 8 days in the hospital. One-year survival was 94.0%. CONCLUSIONS: In the VA medical care system, beneficiaries with diabetes mellitus have an extremely heavy burden of comorbidities, face a significant risk of dying in a given year (approximately 6% in this population), and are heavy users of hospital and outpatient services.

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.

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.

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.