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Objectives: The purpose of this position paper is two-fold: first, to describe the state of extracorporeal membrane oxygenation education worldwide, noting current limitations and challenges; and second, to put forth an educational agenda regarding opportunities for an international collaborative approach toward standardization.Design: Relevant medical literature was reviewed through literature search, and materials from national organizations were accessed through the Internet. Taskforce members generated a consensus statement using an iterative consensus process through teleconferences and electronic communication.Setting: In 2018, the Extracorporeal Life Support Organization convened the ECMOed Taskforce at two structured, face-to-face meetings of 40 healthcare practitioners and educators with expertise in caring for the extracorporeal membrane oxygenation patient and in extracorporeal membrane oxygenation education.Patients: None.Interventions: None.Measurements and Main Results: The ECMOed Taskforce identified seven educational domains that would benefit from international collaborative efforts. Of primary importance, the Taskforce outlined actionable items regarding 1) the creation of a standardized extracorporeal membrane oxygenation curriculum; 2) defining criteria for an extracorporeal membrane oxygenation course as a vehicle for delivering the curriculum; 3) outlining a mechanism for evaluating the quality of educational offerings; 4) utilizing validated assessment tools in the development of extracorporeal membrane oxygenation practitioner certification; and 5) promoting high-quality educational research to guide ongoing educational and competency assessment development.Conclusions: Significant variability and limitations in global extracorporeal membrane oxygenation education exist. In this position paper, we outline a road map for standardizing international extracorporeal membrane oxygenation education and practitioner certification. Ongoing high-quality educational research is needed to evaluate the impact of these initiatives. [ABSTRACT FROM AUTHOR]

Background: Physiologic data that is automatically collected during anesthesia is widely used for medical record keeping and clinical research. These data contain artifacts, which are not relevant in clinical care, but may influence research results. The aim of this study was to explore the effect of different methods of filtering and processing artifacts in anesthesiology data on study findings in order to demonstrate the importance of proper artifact filtering.Methods: The authors performed a systematic literature search to identify artifact filtering methods. Subsequently, these methods were applied to the data of anesthesia procedures with invasive blood pressure monitoring. Different hypotension measures were calculated (i.e., presence, duration, maximum deviation below threshold, and area under threshold) across different definitions (i.e., thresholds for mean arterial pressure of 50, 60, 65, 70 mmHg). These were then used to estimate the association with postoperative myocardial injury.Results: After screening 3,585 papers, the authors included 38 papers that reported artifact filtering methods. The authors applied eight of these methods to the data of 2,988 anesthesia procedures. The occurrence of hypotension (defined with a threshold of 50 mmHg) varied from 24% with a median filter of seven measurements to 55% without an artifact filtering method, and between 76 and 90% with a threshold of 65 mmHg. Standardized odds ratios for presence of hypotension ranged from 1.16 (95% CI, 1.07 to 1.26) to 1.24 (1.14 to 1.34) when hypotension was defined with a threshold of 50 mmHg. Similar variations in standardized odds ratios were found when applying methods to other hypotension measures and definitions.Conclusions: The method of artifact filtering can have substantial effects on estimates of hypotension prevalence. The effect on the association between intraoperative hypotension and postoperative myocardial injury was relatively small. Nevertheless, the authors recommend that researchers carefully consider artifacts handling and report the methodology used. [ABSTRACT FROM AUTHOR]

Background: Concerns about the cost and convenience of postsurgical physical therapy (PT) have sparked interest in unsupervised, home-based rehabilitation. However, the effectiveness of unsupervised home exercise after primary TKA has not been previously evaluated.Questions/purposes: (1) Can unsupervised home exercise after surgery provide noninferior recovery of passive knee flexion compared with formal outpatient PT? (2) Does a web-based platform for home-based exercise provide an advantage compared with a printed PT manual?Methods: We conducted a randomized, noninferiority trial involving 290 patients (20% of the 1464 eligible patients who could be contacted) who underwent primary TKA from March 2016 to April 2018. We included patients > 18 years old who were undergoing primary, unilateral TKA and provided written consent. We excluded patients with preoperative knee flexion < 90°, patients considering surgical intervention in a hip or the contralateral knee, patients discharged to an extended care facility, and revision or conversion TKA. We randomized patients to one of three groups: outpatient PT, unsupervised home exercise using a web-based platform (web PT), or unsupervised home exercise using a printed paper manual (paper PT). We also implemented a "delayed recovery intervention" within the home exercise program, in which patients were obliged to begin outpatient PT if knee flexion was < 70° at 2 weeks or < 90° at 4 weeks. The primary outcome was change in knee flexion from preoperative baseline after 4 to 6 weeks and 6 months. Secondary outcomes included Knee Injury and Osteoarthritis Outcome Score (KOOS), time back to activities of daily living, and time off narcotics. All analyses were intention to treat, and the noninferiority margin was 5% with maximum flexion as the outcome of interest for this parameter.Results: Adjusted differences in change in passive flexion for web PT +3° (95% confidence interval [CI], -1.2° to 6.4°) and paper PT +5° (95% CI, 0.99°-8.6°) were not inferior to outpatient PT based on a predefined 5° margin. Change in knee flexion from baseline was 0° for outpatient PT, -2° for web PT, and -1° for paper PT after 4 to 6 weeks and 8°, 8°, and 12° for the three groups, respectively, after 6 months. Additionally, there was no difference in the change in KOOS from baseline at 4 to 6 weeks or 6 months postoperatively as well as time back to work, driving, and walking without an assistive device.Conclusions: Unsupervised home exercise is an effective rehabilitation strategy after primary TKA and was noninferior to formal outpatient PT in selected patients. It is worthwhile to reconsider the current practice of automatically designating patients for outpatient PT after primary TKA, because appropriately selected patients with adequate clinical support can achieve similar results at home.Level Of Evidence: Level I, therapeutic study. [ABSTRACT FROM AUTHOR]

Background: Although tenotomy and tenodesis are frequently used for long head of the biceps tendon lesions, controversies remain as to which technique is superior regarding pain, functionality, complications, and cosmetic appearance.Questions/purposes: (1) For long head of biceps tendon lesions, does tenotomy or tenodesis result in greater improvements in VAS score for pain? (2) Which approach has superior results when evaluating function outcome (Constant) scores? (3) Does tenotomy or tenodesis have fewer complications? (4) Does tenotomy or tenodesis result in better cosmesis (Popeye sign)?Methods: A systematic review was performed in the Cochrane Library, Embase, PubMed, and Literatura Latino Americana e do Caribe em Ciências da Saúde (LILACS) using the keywords "long head of the biceps tendon," "biceps tenodesis," and "tenotomy." We completed the search in June 2020. The inclusion criteria were randomized controlled trials and quasirandomized controlled trials that investigated tenodesis and tenotomy with no language restriction and evaluation of adult patients who presented with a long head of the biceps tendon lesion, associated with other lesions or not, without previous shoulder surgeries and who had no response to nonoperative treatment. The initial search yielded 239 studies, 40 of which were duplicates. We assessed the titles and abstracts of 199 articles and excluded all studies that were not randomized controlled trials (literature reviews) or that compared different techniques. We assessed the full text of 14 articles and excluded the ones that were protocols and cohort studies. We evaluated the risk of bias using the Cochrane Collaboration tool. We included eight studies in this systematic review and meta-analysis, with a total of 615 participants, 306 of whom were treated with tenotomy and 309 with tenodesis. The median duration of follow-up was 2 years. Overall, the included studies had a low risk of bias. The complications evaluated were adhesive capsulitis, biceps brachii tear, cramps, and a subsequent second surgical procedure. We used a random model in this meta-analysis so that we could generalize the results beyond the included studies. In this study, we only reported differences between the groups if they were both statistically valid and larger than the minimum clinically important difference (MCID).Results: Comparing tenotomy and tenodesis, we observed no difference between the groups regarding pain in the long term (mean difference 0.25 [95% confidence interval -0.29 to 0.80]; p = 0.36). There was no difference in Constant score in the long-term (mean difference -1.45 [95% CI -2.96 to 0.06]; p = 0.06). There were no differences when evaluating for major complications (odds ratio 1.37 [95% CI 0.29 to 6.56]; p = 0.70). There were not enough papers evaluating adhesive capsulitis, cramping, and risk of revision surgery. Popeye sign was more frequent in the tenotomy group than in the tenodesis group (OR 4.70 [95% CI 2.71 to 8.17]; p < 0.001).Conclusion: This systematic review demonstrated that tenotomy and tenodesis offer satisfactory treatment for long head of the biceps tendon lesions. In terms of pain improvement and Constant score, there was no difference between the techniques, but patients undergoing tenotomy have worse cosmetic results. Therefore, surgeons should choose the technique based on their skills and the patient's expectations of surgery, such as cosmesis and time to recovery. More studies are needed to evaluate complications such as adhesive capsulitis and cramping, as well as to compare duration of surgery and recovery time for each technique.Level Of Evidence: Level I, therapeutic study. [ABSTRACT FROM AUTHOR]

Objectives: The age-appropriate colorectal cancer (CRC) screening rate in the rural Appalachian area is low compared with the national rate, which may account for the overall higher incidence of CRC in this area. The purpose of this study was to explore potential barriers to CRC screening in the West Virginia Appalachian area.Methods: A cross-sectional survey was designed to identify patient-reported barriers to CRC screening using the health belief model to assess their attitudes and behaviors. Autonomous paper-based surveys were randomly handed to individuals older than 50 years at various locations, including healthcare and nonhealthcare facilities. All of the responses were then categorized into two groups: the screened group and the unscreened group. Differences among both groups were statistically analyzed.Results: There were three main areas that significantly accounted for the discrepancies between the screened and unscreened groups: perceptions of discomfort from screening tests, psychological and behavior deterrents in CRC screening and diagnosis, and limited resources for accessing care, especially transportation. In particular, psychological and behavioral deterrents in CRC screening appeared to play a role in promoting aversion to CRC screening.Conclusions: Lack of CRC screening awareness and knowledge may be responsible for fatalism regarding CRC and aversion to screening. Thus, multidisciplinary interventions that provide education about CRC screening, early intervention prognosis, and treatment options, as well as addressing systemic barriers to screening, such as assistance with scheduling, prep instructions, and transportation, can improve the screening rate in Appalachia and eventually lead to better outcomes through the early diagnosis of CRC. [ABSTRACT FROM AUTHOR]

Objectives: Women veterans have a high prevalence of comorbidities that increase the risk of adverse pregnancy outcomes. Screening for pregnancy desires in primary care provider (PCP) visits offers an opportunity to optimize preconception health. This pilot quality improvement initiative sought to assess Veterans Healthcare Administration provider preferences on One Key Question (OKQ) implementation, identification of veterans' reproductive needs, and the effect of training on documentation in a women's primary care clinic in Salt Lake City, Utah.Methods: We hosted OKQ training sessions for providers and staff, audio recorded group discussions on implementation barriers, and explored themes. Women veterans presenting for a PCP visit in July 2018 self-completed a paper OKQ screening tool. We calculated summary statistics on responses. We conducted a pre-post analysis, with respect to training sessions, to measure for changes in family planning documentation during PCP visits.Results: Nineteen providers and staff completed the training. They acknowledged the importance, but believed that the screening tool should be completed by veterans and not be provider prompted. Forty-two women veterans completed the screening tool: 21% desired pregnancy in the next year and 26% desired contraceptive information. Chart reviews found a nonsignificant increase in current contraceptive method documentation between periods (20% vs 37%; P = 0.08), a decline in documentation of reproductive goals (22% vs 3%; P = 0.02), and no significant change in counseling.Conclusions: Veterans identify reproductive needs via the OKQ screening tool, but provider documentation did not reflect changes in care following training. Further study is necessary to develop an optimal, patient-centered tool and implementation plan to support women veterans in their reproductive goals. [ABSTRACT FROM AUTHOR]

Background: Displaced mid-third clavicle fractures are common, and their management remains unclear. Although several meta-analyses have compared specific operative techniques with nonoperative management, it is not possible to compare different operative constructs with one another using a standard meta-analysis. Conversely, a network meta-analysis allows comparisons among more than two treatment arms, using both direct and indirect comparisons between interventions across many trials. To our knowledge, no network meta-analysis has been performed to compare the multiple treatment options for displaced clavicle fractures.Questions/purposes: We performed a network meta-analysis of randomized, controlled trials (RCTs) to determine from among the approaches used to treat displaced midshaft clavicle fractures: (1) the intervention with the highest chance of union at 1 year, (2) the intervention with the lowest risk of revision surgery, and (3) the intervention with the highest functional outcome scores. Secondarily, we also (4) compared the surgical subtypes in the available RCTs on the same above endpoints.Methods: MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were reviewed for relevant randomized controlled trials published up to July 25, 2018. Two hundred and eighty four papers were reviewed, with 22 meeting inclusion criteria of RCTs with appropriate randomization techniques, adult population, minimum of 1 year follow-up and including at least one operative treatment arm. In total, 1002 patients were treated with a plate construct, 378 with an intramedullary device, and 585 patients were managed nonoperatively. Treatment subtypes included locked intramedullary devices (56), unlocked intramedullary devices (322), anterior plating (89), anterosuperior plating (150), superior plating (449) or plating not otherwise specified (314). We performed a network meta-analysis to compare and rank the treatments for displaced clavicle fractures. We considered the following outcomes: union achievement, revision surgery risk and functional outcomes (DASH and Constant Scores). The minimal clinically important difference (MCID) was considered for both Constant and DASH scores to be at 8 points, representing the average of MCID scores reported for both DASH and Constant in the evidence, respectively.Results: Union achievement was lower in patients treated nonoperatively (88.9%), and higher in patients treated operatively (96.7%, relative risk [RR] 1.128 [95% CI 1.1 to 1.17]; p < 0.001), Number needed to treat (NNT) = 10). Union achievement increased with any plate construct (97.8%, RR 1.13 [95% CI 1.1 to 1.7]; p < 0.0001, NNT = 9) and with anterior or anterosuperior plates (99.3%, RR 1.14 [95% CI 1.1 to 1.8]; p < 0.0001, NNT = 8). Risk of reoperation, when considering planned removal of hardware, was similar across all treatment arms. Lastly, operative treatment outperformed nonoperative treatment with minor improvements in DASH and Constant scores, though not approaching the MCID. At the subtype level, anterosuperior plating ranked highest in DASH and Constant functional scores with mean differences reaching 10-point improvement for Constant scores (95% CI 4.4 to 2.5) and 7.6 point improvement for DASH (95% CI 5.2 to 20).Conclusions: We found that surgical treatment led to a greater likelihood of union at 1 year of follow-up among adult patients with displaced mid-third clavicle fractures. In aggregate, surgical treatment did not increase functional scores by amounts that patients were likely to consider clinically important. Use of specific subtypes of plating (anterior, anterosuperior) resulted in improvements in the Constant score that were slightly above the MCID but did not reach the MCID for the DASH score, suggesting that any outcomes-score benefits favoring surgery were likely to be imperceptible or small. In light of these findings, we believe patients can be informed that surgery for this injury can increase the likelihood of union incrementally (about 10 patients would need to undergo surgery to avoid one nonunion), but they should not expect better function than they would achieve without surgery; most patients can avoid surgery altogether with little absolute risk of nonunion. Patients who opt for surgery must be told that the decision should be weighed against complications and the possibility of undergoing a second procedure for hardware removal. Patients opting not to have surgery for acute midshaft clavicle fractures can be told that nonunion occurs in slightly more than 10% of patients, and that these can be more difficult to manage than acute fractures.Level Of Evidence: Level I, therapeutic study. [ABSTRACT FROM AUTHOR]

Objective: To evaluate maternal mortality and changes in the culture of safety before and after the implementation of the Alliance for Innovation on Maternal Health (AIM) Malawi program.Methods: This was a prospective cohort study at a central hospital and a district health center in Malawi from March 2016 to November 2017. The AIM Malawi program included classroom didactics on obstetric hemorrhage, teamwork protocols, skills laboratory activities, and simulation training. The time periods of comparison were preintervention, education period, and postintervention. Hospital birth paper records were used to collect data on patient demographics and obstetric and neonatal information. The Hospital Survey of Patient Safety was used to measure the culture of safety before and after the program.Results: We trained 128 participants. In the postintervention period, 16 procedural interventions were performed to manage postpartum hemorrhage, including B-lynch sutures (n=7), condom balloon catheter (n=5), nonpneumatic antishock garment (n=3), and uterine artery ligation (n=1). There was a significant increase in the use of B-lynch sutures for the management of uterine atony in the postintervention compared with preintervention period (P=.014). In the postintervention period, the rate of maternal mortality from obstetric hemorrhage decreased significantly from 1.2% to 0.2% (P=.02), a relative decrease of 82.1% from the preintervention rate. Hospital safety culture scores improved significantly from baseline in four out of five domains after the AIM Malawi training.Conclusion: After implementation of the AIM Malawi program, we found an increased use of postpartum hemorrhage procedural interventions, a decreased rate of maternal mortality and an increase in Hospital Survey of Patient Safety composite safety scores. The AIM Malawi program may be an effective framework for adaptation to improve maternal mortality in a low-resource setting. [ABSTRACT FROM AUTHOR]

Many advocates of quality improvement (QI) suggest that there is a link between an organization's leadership commitment and culture and its ability to implement a QI initiative. This paper reports empirical evidence from a study of QI implementation in Veterans Health Administration (VHA) hospitals that supports this hypothesized linkage. The findings suggest that the extent to which top management becomes directly involved in QI activities determines the degree of QI implementation. Additionally, study findings suggest that a culture emphasizing innovation and teamwork provides an important foundation for implementing a QI initiative. We discuss the implications of these findings for organizational leaders interested in implementing QI. [ABSTRACT FROM PUBLISHER]

Background: Traditional patient-reported outcome instruments like the Foot and Ankle Ability Measure (FAAM) quantify patient disability but often are limited by responder burden and incomplete questionnaires. The Patient-Reported Outcome Measurement Information System (PROMIS) overcomes such obstacles through computer-adaptive technology and can capture outcome data from various domains including physical and psychosocial function. Prior work has compared the FAAM with PROMIS physical function; however, there is little evidence comparing the association between foot and ankle-specific tools like the FAAM with more general outcomes measures of PROMIS pain interference and depression in foot and ankle conditions.Questions/purposes: (1) We asked whether there was a relationship between FAAM Activities of Daily Living (ADL) scores with PROMIS physical function, pain interference, and depression in patients with hallux valgus. (2) Additionally, we asked if we could identify specific factors that are associated with variance in FAAM and PROMIS physical function scores in patients with hallux valgus.Methods: Eighty-five new patients with either a primary or secondary diagnosis of hallux valgus based on clinic billing codes from July 2015 to February 2016 were retrospectively identified. Patients completed FAAM ADL paper-based surveys and electronic PROMIS questionnaires for physical function, pain interference, and depression from new patient visits at a single time. Spearman rho correlations were performed between FAAM ADL and PROMIS scores. Analyses then were used to identify differences in FAAM ADL and PROMIS physical function measures based on demographic variables. Stepwise linear regressions then determined which demographic and/or outcome variable(s) accounted for the variance in FAAM ADL and PROMIS physical function scores.Results: FAAM scores correlated strongly with PROMIS physical function (r = 0.70, p < 0.001), moderately with PROMIS pain interference (r = -0.65, p < 0.001), and weakly with PROMIS depression (r = -0.35, p < 0.001) scores. Regression analyses showed that PROMIS pain interference scores alone were associated with sizeable portions of the variance in FAAM ADL (R2 = 0.44, p < 0.001) and PROMIS physical function (R2 = 0.57, p < 0.001) measures.Conclusions: PROMIS function and pain measures correlated with FAAM ADL scores, highlighting the interrelationship of pain and function when assessing outcomes in patients with hallux valgus. PROMIS tools allow for more-efficient data collection across multiple domains and, moving forward, may be better poised to monitor changes in pain and function with time compared with traditional outcome measures like the FAAM.Clinical Relevance: The relationships shown here between PROMIS and FAAM scores further support the use of PROMIS tools in outcomes-based research. In patients with hallux valgus, pain-related disability appears to be a central feature of the patient-experience. Future studies should assess the association of various outcome domains on other common foot and ankle diagnoses. [ABSTRACT FROM AUTHOR]

This study compares the outcomes, from pretreatment to 1-year follow-up, of an outpatient, CBT-based pain self-management program (PSM) that included exercises, pain education, and pain coping strategies, with a control condition (exercise-attention control, EAC) that included exercises and a control for the attention of the treatment team. We previously reported short-term results (to 1-month follow-up) from the same study. This new paper considers the important issue of maintenance of treatment-related gains. The participants (n = 141) were a heterogeneous sample of ambulant, community-dwelling older adult patients with chronic pain (mean age: 73.90 [6.5] years [range: 65-87 years]). The long-term results indicate the pain self-management program group achieved and maintained significantly better results than the exercise-attention control group on the primary outcome, pain-related disability, as well as on usual pain, pain distress, depression, and fear-avoidance beliefs. The mean effect size for these gains by the pain self-management program group over the exercise-attention control group was 0.37 (range: 0.29-0.45), which is in the small effect size range. While statistically and clinically meaningful, these findings do indicate some weakening in effects over time but not to a significant degree. The study has implications for the provision of pain management interventions for community-dwelling older adults with chronic pain. [ABSTRACT FROM AUTHOR]

Background: Multistep immunoassay kits for the diagnosis of rupture of membranes are relatively complex and are not designed to be used by pregnant women themselves. These kits require procedural steps of specimen extraction and preparation. We evaluated the ability of a sanitary pad containing a qualitative immunoassay for alpha-fetoprotein (AFP) to serve as a one-step self-test to detect amniotic fluid leakage.Technique: Four sets of pads were evaluated. The pads in the study set were worn by 288 pregnant women with confirmed rupture of membranes. Three controls were evaluated: 1) pads worn by 93 pregnant women with intact membranes, 2) additional pads instilled with urine specimens obtained from the 381 women described previously (study set plus control set 1), and 3) pads instilled with semen collected from 40 men.Experience: All 288 pads that absorbed amniotic fluid had positive results. Approximately half of the pads absorbed with normal vaginal discharge had a sufficient amount to yield valid results, which were all negative. All 381 pads with instilled urine and all 40 pads with instilled semen had negative results.Conclusion: An immunoassay for AFP, embedded in a pad, appears to be a feasible and reproducible self-test for the detection of rupture of membranes. [ABSTRACT FROM AUTHOR]

Misclassification of binary outcome variables is a known source of potentially serious bias when estimating adjusted odds ratios. Although researchers have described frequentist and Bayesian methods for dealing with the problem, these methods have seldom fully bridged the gap between statistical research and epidemiologic practice. In particular, there have been few real-world applications of readily grasped and computationally accessible methods that make direct use of internal validation data to adjust for differential outcome misclassification in logistic regression. In this paper, we illustrate likelihood-based methods for this purpose that can be implemented using standard statistical software. Using main study and internal validation data from the HIV Epidemiology Research Study, we demonstrate how misclassification rates can depend on the values of subject-specific covariates, and we illustrate the importance of accounting for this dependence. Simulation studies confirm the effectiveness of the maximum likelihood approach. We emphasize clear exposition of the likelihood function itself, to permit the reader to easily assimilate appended computer code that facilitates sensitivity analyses as well as the efficient handling of main/external and main/internal validation-study data. These methods are readily applicable under random cross-sectional sampling, and we discuss the extent to which the main/internal analysis remains appropriate under outcome-dependent (case-control) sampling. [ABSTRACT FROM AUTHOR]

Ill-defined causal questions present serious problems for observational studies-problems that are largely unappreciated. This paper extends the usual counterfactual framework to consider causal questions about compound treatments for which there are many possible implementations (for example, "prevention of obesity"). We describe the causal effect of compound treatments and their identifiability conditions, with a special emphasis on the consistency condition. We then discuss the challenges of using the estimated effect of a compound treatment in one study population to inform decisions in the same population and in other populations. These challenges arise because the causal effect of compound treatments depends on the distribution of the versions of treatment in the population. Such causal effects can be unpredictable when the versions of treatment are unknown. We discuss how such issues of "transportability" are related to the consistency condition in causal inference. With more carefully framed questions, the results of epidemiologic studies can be of greater value to decision-makers. [ABSTRACT FROM AUTHOR]

Uncontrolled confounding in observational studies gives rise to biased effect estimates. Sensitivity analysis techniques can be useful in assessing the magnitude of these biases. In this paper, we use the potential outcomes framework to derive a general class of sensitivity-analysis formulas for outcomes, treatments, and measured and unmeasured confounding variables that may be categorical or continuous. We give results for additive, risk-ratio and odds-ratio scales. We show that these results encompass a number of more specific sensitivity-analysis methods in the statistics and epidemiology literature. The applicability, usefulness, and limits of the bias-adjustment formulas are discussed. We illustrate the sensitivity-analysis techniques that follow from our results by applying them to 3 different studies. The bias formulas are particularly simple and easy to use in settings in which the unmeasured confounding variable is binary with constant effect on the outcome across treatment levels. [ABSTRACT FROM AUTHOR]

Background: Data with some values below a limit of detection (LOD) can be analyzed using methods of survival analysis for left-censored data. The reverse Kaplan-Meier (KM) estimator provides an effective method for estimating the distribution function and thus population percentiles for such data. Although developed in the 1970s and strongly advocated since then, it remains rarely used, partly due to limited software availability. Methods: In this paper, the reverse KM estimator is described and is illustrated using serum dioxin data from the University of Michigan Dioxin Exposure Study (UMDES) and the National Health and Nutrition Examination Survey (NHANES). Percentile estimates for left-censored data using the reverse KM estimator are compared with replacing values below the LOD with the LOD/2 or LOD/ radical2. Results: When some LODs are in the upper range of the complete values, and/or the percent censored is high, the different methods can yield quite different percentile estimates. The reverse KM estimator, which is the nonparametric maximum likelihood estimator, is the preferred method. Software options are discussed: The reverse KM can be calculated using software for the KM estimator. The JMP and SAS (SAS Institute, Cary, NC) and Minitab (Minitab, Inc, State College, PA), software packages calculate the reverse KM directly using their Turnbull estimator routines. Conclusion: The reverse KM estimator is recommended for estimation of the distribution function and population percentiles in preference to commonly used methods such as substituting LOD/2 or LOD/ radical2 for values below the LOD, assuming a known parametric distribution, or using imputation to replace the left-censored values. [ABSTRACT FROM AUTHOR]

The objective of this research was to examine the performance of a brief patient survey about quality of care received in community-based diagnostic and therapeutic facilities. The survey was administered to patients in 44 facilities that were also scheduled for a formal external assessment. The response rate was 53%. Patients generally rated their care positively; 18.5% of patients rated at least 1 item as fair or poor. The amount of information received about risks and complications was rated least favorably; concern and caring shown by staff was rated most favorably. The 10 items which patients rated regarding aspects of quality formed an internally consistent scale (alpha = .93). Patients' ratings were not useful predictors of assessor ratings. Although patients' ratings cannot substitute for expert on-site assessments, they are an important part of a quality management program. The patient survey provides additional, complementary information about components of quality care that are important to them. [ABSTRACT FROM AUTHOR]

Computerized information systems have become an in-dispensable source of quality improvement data in the healthcare field. The degree to which we are successful in using these systems is limited only by our ability to ask the right questions. In this study, computerized patient records were used to evaluate the uniformity in the prescribing patterns for oral corticosteroids among house staff and attending physicians as a measure of the adequacy of resident supervision in the outpatient setting. Retrospective analysis of the records of 771 outpatients receiving prescriptions for oral corticosteroid preparations over 1 year in a large tertiary-care university-affiliated Department of Veterans Affairs Medical Center indicated different prescribing patterns for attending physicians and house staff. Additionally, it was noted that house staff tended to manage more complex patients than did attending physicians. We further evaluated the clinical outcomes of these patients to assess the quality, appropriateness, and comparability of care within cohorts of patients and to determine the degree to which resident supervision may have affected outcomes. The study results suggest that there is an opportunity to improve the management of patients treated with oral corticosteroid therapy by increasing staff physician involvement either through direct care of the most complex cases or through enhanced resident supervision. [ABSTRACT FROM PUBLISHER]

The purpose of this study was to characterize the barriers to tight control of diabetes mellitus. The study collected data from multiple sources at a primary health care clinic in an academic teaching hospital serving an urban population, including patients' charts, structured interviews with patients, a survey of physicians' general perspectives and beliefs concerning diabetes mellitus, and a physician's structured review of barriers to tight control for individual patients. One hundred thirty-five patients with scheduled appointments were eligible for the study, of whom 94% had had a recent hemoglobin A1C (HbA1C). Seventy-seven of 88 patients (88%) who presented for their appointments consented to the interview, 48 of 50 providers (96%) returned useable surveys, and providers completed individual assessments for 96 patients (71%). Patients had a mean age of 61 years, an average of 7.60 diagnoses, and an average of 8.96 prescriptions. Their diabetes control was less than ideal, with less than 15% having normal or near normal control and almost a quarter having poor control. Correlations of HbA1C with age and show rate were seen. Physicians' assessments showed that motivation and understanding of diabetes and compliance with diet and medications correlated with diabetes control. Neither patient knowledge nor physician knowledge appeared to be a problem, nor did either correlate with diabetes control. The number of barriers to control were many, with over half of the patients having five or more barriers. Tight control of blood glucose is felt to be an important aspect of quality care for diabetic patients. In this study, a representative sample of diabetic patients had less than ideal diabetes control. This population was receiving their care in an urban setting and had many comorbid illnesses and many barriers to control. Age, motivation, understanding of the disease, show rate, and compliance with diet and medications had statistical correlations with diabetes control. In order to improve the quality of care for diabetic patients, barriers to care must be addressed. [ABSTRACT FROM AUTHOR]

The prevention of medication administration errors (MAEs) represents a central focus of hospitals' quality improvement and risk management initiatives. Because the identification and reporting of MAEs is a nonautomated and voluntary process, it is essential to understand the extent to which errors may not be reported. This study reports the results of 2 multihospital surveys in which over 1300 staff nurses in each survey estimated the extent to which various types of nonintravenous (non-i.v.) and intravenous (i.v.)-related MAEs are actually being reported on their nursing units. Overall, respondents estimated that about 60% of MAEs are actually being reported. Considerable differences in estimated rates of MAE reporting were found between staff and supervisors working on the same patient care units. A simulation based on actual and perceived rates of MAE reporting is presented to estimate the range of errors not being reported. Implications regarding the reliability, validity, and completeness of MAEs actually being reported are discussed. [ABSTRACT FROM AUTHOR]

The VA has implemented a nationwide evaluation program to monitor process and outcome of care for substance abuse patients. This program focuses on the changing characteristics of VA substance abuse patients and treatment services and involves outcome-based evaluations of major VA substance abuse treatment modalities. Initial findings show that VA substance abuse patients, including patients with concomitant psychiatric disorders, improve substantially from treatment intake to a 1-year follow-up and that community residential facilities are an important part of the continuum of substance abuse care. Moreover, within broad limits, there is a dose-response relationship between the continuity of outpatient mental health care and better 1-year substance use and psychosocial outcomes. These findings are placed into context as part of an evidence-based initiative to improve the quality of VA mental health care. [ABSTRACT FROM PUBLISHER]

The objective of this study was to describe patterns of hospital and clinic use and survival for a large nationwide cohort of patients with heart failure. A retrospective cohort study of patients treated in the Veterans Affairs medical care system was conducted using linked administrative databases as data sources. In 1996, the average heart failure cohort member had 1-2 hospitalizations, 14 inpatient days, 6-7 visits with the primary physician, 15 other visits for consultations or tests, and 1-2 urgent care visits per 12 months. The overall risk-adjusted 5-year survival rate was 36%. Hospital use rates in the cohort fell dramatically between 1992 and 1996. One-year survival rates increased slightly over the period. Patients with heart failure are heavy users of services and have a very poor prognosis. Utilization and outcome data indicate the need for major efforts to assure quality of care and to devise innovative ways of delivering comprehensive services. [ABSTRACT FROM PUBLISHER]

Recently, the Veterans Administration (VA) Under Secretary for Health has designated functional status as one of the domains of value for the system, given its increasing importance for clinical care. The Veterans Health Study (VHS) was designed to assist the VA in monitoring outcomes and measuring the case mix of patients who use the VA. The Veterans SF-36 (short form functional status assessment for veterans) was administered to 2425 veterans receiving ambulatory care. Measures of the Veterans SF-36 were strongly correlated with sociodemographics and morbidities of the veterans. Young veterans had poorer mental health status than older veterans. Veterans who used ambulatory care in the VHS reported lower levels of health status, reflecting more disease than a non-VA civilian population. These measures of health are important indicators of the disease burden or case mix of the patients and are pertinent to health systems such as the VA for resource allocation decisions and as outcomes of care. [ABSTRACT FROM PUBLISHER]

Although managed care seems to serve well the in terests of non-elderly enrollees and their payers, elderly people face more risks. Chronic conditions, multiple prob lems, and more limited resources make them more vul nerable, whereas multiple payer sources make them more complicated to cover. This synthesis of managed care de livered in Medicare and Medicaid demonstration projects serving elderly beneficiaries shows that managed care plans either select or attract enrollees who suffer fewer frailties than those served in fee-for-service settings, ex hibit reluctance to enter rural markets, provide a broad range of elderly-specific services, offer more compre hensive coverage and services, and result in greater per ceived access problems, particularly for vulnerable subgroups. Plans operate more cheaply by using fewer resources, even after adjusting for case mix differences. Managed care enrollees tend to be more satisfied with financial and coverage aspects, whereas fee-for-service enrollees report higher satisfaction on other dimensions. In acute care settings, process of care findings were mixed, whereas clinical and self-reported outcome indi cators were no better and in some instances worse in managed care. Long-term care enrollees, in the few stud ies reported, consistently faired worse in both the processes and outcomes of care. These findings suggest that further research on the effects of managed care in its rapidly changing incarnations is needed, particularly with respect to how to improve the quality of acute and long-term care delivered to elderly people and the proper role of government and other key actors in the health care system. [ABSTRACT FROM PUBLISHER]

Although approximately one of five people in the United States die in nursing homes (NHs), little has been written about their quality of dying, including the quality of terminal medical care. The purpose of this study is to review actual medical practices in NHs to suggest factors important for delivering good quality terminal care. Four NHs were surveyed for management of residents who died in 1992. A convenience sample of charts of newly admitted and longer term residents were abstracted for demographic variables, death, diagnostic categories, and various laboratory and other parameters. Charts of those residents who died were further reviewed using indicators of quality medical care, such as presence of advance directives, control of pain, and control of dyspnea, based upon recent published clinical practice guidelines for terminal care in NHs. Three hundred and seventy-one charts were abstracted. Forty-one charts documented the resident's death. We found that NHs without regulatory difficulties usually had expected deaths that were managed appropriately as measured by terminal medical care quality indicators. NHs with a history of regulatory difficulties had a higher prevalence of residents who died suddenly and unexpectedly, often with problems in the quality of care as measured by the same indicators. There was a correspondence between physician certification, antemortem diagnosis of terminal illness, and appropriate terminal care. We conclude that physicians are able to recognize impending death and redirect the medical care of dying NH residents toward goals of terminal care management. This is more likely to occur in a NH environment that places greater emphasis upon total quality management. We suggest that another indicator in providing good NH terminal care is the physician's performance in predicting a short life expectancy. [ABSTRACT FROM PUBLISHER]

We explored the use of postoperative adverse events of cholecystectomy as possible screens for poor quality of care. Retrospective analysis of clinical data ab stracted from hospital charts between 1985-1986 was conducted on a random sample of 3,182 cholecystectomy cases. Severity of illness models were developed pre dicting adverse events following cholecystectomy in pa tients with and without bile duct exploration. Outcome measures included 17 nonfatal adverse events and death within 30 days of admission. Adverse event rates were 23.2% for cases with bile duct exploration and 14.4% for cases without bile duct exploration. Cross-validated R-squareds and C-statistics showed that models had real, although modest, predictive power. We conclude that clinically meaningful adverse events of cholecystec tomy can be successfully identified through chart ab straction. [ABSTRACT FROM PUBLISHER]

Cruzan v. Director, Missouri Department of Health, the first "right do die" case to be decided by the United States Supreme Court, constitutionalizes the principle of patient self-determination. The case encourages competent patients to reflect thoughtfully about the possibility that one day they may be inca pacitated just as Nancy Beth Cruzan was and to pre pare for that possibility by completing an advance directive. Furthermore, the recently enacted Patient Self-Determination Act requires hospitals to ask adult patients upon admission whether they have ad vance directives. However, a number of practical concerns arise for physicians about operationalizing these patient self-determination principles within their states and their scopes of practice. Will physi cians be prosecuted for "assisting suicides" if they withdraw feeding tubes or forgo other life-sustaining treatments? Will physicians be liable in medical mal practice for "undertreatment" or "overtreatment" in such cases? Will physicians be asked to violate their own moral codes in treating patients? Will others intrude into the traditional physician-patient rela tionship and decision-making process? Will physi cians be caught in the middle of troublesome family, staff, and institutional disputes? How will phy sicians learn of patients' advance directives? Will physicians be asked to continue care in futile cases? Will Cruzan's self-determination doctrine be improperly ex tended ? Successful implementation of patient self- determination principles will require consideration and discussion of these practical physician concerns. [ABSTRACT FROM PUBLISHER]