David C. Aron

Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science

BackgroundMany interventions found to be effective in health services research studies fail to translate into meaningful patient care outcomes across multiple contexts. Health services researchers recognize the need to evaluate not only summative outcomes but also formative outcomes to assess the extent to which implementation is effective in a specific setting, prolongs sustainability, and promotes dissemination into other settings. Many implementation theories have been published to help promote effective implementation. However, they overlap considerably in the constructs included in individual theories, and a comparison of theories reveals that each is missing important constructs included in other theories. In addition, terminology and definitions are not consistent across theories. We describe the Consolidated Framework For Implementation Research (CFIR) that offers an overarching typology to promote implementation theory development and verification about what works where and why across multiple contexts.MethodsWe used a snowball sampling approach to identify published theories that were evaluated to identify constructs based on strength of conceptual or empirical support for influence on implementation, consistency in definitions, alignment with our own findings, and potential for measurement. We combined constructs across published theories that had different labels but were redundant or overlapping in definition, and we parsed apart constructs that conflated underlying concepts.ResultsThe CFIR is composed of five major domains: intervention characteristics, outer setting, inner setting, characteristics of the individuals involved, and the process of implementation. Eight constructs were identified related to the intervention (e.g., evidence strength and quality), four constructs were identified related to outer setting (e.g., patient needs and resources), 12 constructs were identified related to inner setting (e.g., culture, leadership engagement), five constructs were identified related to individual characteristics, and eight constructs were identified related to process (e.g., plan, evaluate, and reflect). We present explicit definitions for each construct.ConclusionThe CFIR provides a pragmatic structure for approaching complex, interacting, multi-level, and transient states of constructs in the real world by embracing, consolidating, and unifying key constructs from published implementation theories. It can be used to guide formative evaluations and build the implementation knowledge base across multiple studies and settings.

Adherence to Surgical Care Improvement Project Measures and the Association With Postoperative Infections

CONTEXT The Surgical Care Improvement Project (SCIP) aims to reduce surgical infectious complication rates through measurement and reporting of 6 infection-prevention process-of-care measures. However, an association between SCIP performance and clinical outcomes has not been demonstrated. OBJECTIVE To examine the relationship between SCIP infection-prevention process-of-care measures and postoperative infection rates. DESIGN, SETTING, PARTICIPANTS A retrospective cohort study, using Premier Incs Perspective Database for discharges between July 1, 2006 and March 31, 2008, of 405 720 patients (69% white and 11% black; 46% Medicare patients; and 68% elective surgical cases) from 398 hospitals in the United States for whom SCIP performance was recorded and submitted for public report on the Hospital Compare Web site. Three original infection-prevention measures (S-INF-Core) and all 6 infection-prevention measures (S-INF) were aggregated into 2 separate all-or-none composite scores. Hierarchical logistical models were used to assess process-of-care relationships at the patient level while accounting for hospital characteristics. MAIN OUTCOME MEASURE The ability of reported adherence to SCIP infection-prevention process-of-care measures (using the 2 composite scores of S-INF and S-INF-Core) to predict postoperative infections. RESULTS There were 3996 documented postoperative infections. The S-INF composite process-of-care measure predicted a decrease in postoperative infection rates from 14.2 to 6.8 per 1000 discharges (adjusted odds ratio, 0.85; 95% confidence interval, 0.76-0.95). The S-INF-Core composite process-of-care measure predicted a decrease in postoperative infection rates from 11.5 to 5.3 per 1000 discharges (adjusted odds ratio, 0.86; 95% confidence interval, 0.74-1.01), which was not a statistically significantly lower probability of infection. None of the individual SCIP measures were significantly associated with a lower probability of infection. CONCLUSIONS Among hospitals in the Premier Inc Perspective Database reporting SCIP performance, adherence measured through a global all-or-none composite infection-prevention score was associated with a lower probability of developing a postoperative infection. However, adherence reported on individual SCIP measures, which is the only form in which performance is publicly reported, was not associated with a significantly lower probability of infection.

Reliability of birth certificate data: a multi-hospital comparison to medical records information.

Objective: To examine the reliability of birth certificate data and determine if reliability differs between teaching and nonteaching hospitals. Methods: We compared information from birth certificates and medical records in 33,616 women admitted for labor and delivery in 1993–95 to 20 hospitals in Northeast Ohio. Analyses determined the agreement for 36 common data elements, and the sensitivity, specificity, and positive and negative predictive values of birth certificate data, using medical record data as a “gold standard.” Results: Sensitivity and positive predictive value varied widely (9–100% and 2–100%, respectively), as did agreement, which was “almost perfect” for measures of prior obstetrical history, delivery type, and infant Apgar score (κ = 0.854–0.969) and “substantial” for several other variables (e.g., tobacco use (κ = 0.766), gestational age (κ = 0.726), prenatal care (κ = 0.671)). However, agreement was only “slight” to “moderate” for most maternal risk factors and comorbidities (κ = 0.085–0.545) and for several complications of pregnancy and/or labor and delivery (κ = 0.285–0.734). Overall agreement was similar in teaching (mean κ = 0.51) and nonteaching (κ = 0.52) hospitals. Although agreement in teaching and nonteaching hospitals varied for some variables, no systematic differences were seen across types of variables. Conclusions: Our findings indicate that the reliability of birth certificate data vary for specific elements. Researchers and health policymakers need to be cognizant of the potential limitations of specific data elements.

SEXUAL FUNCTION IN MEN WITH DIABETES TYPE 2: ASSOCIATION WITH GLYCEMIC CONTROL

PURPOSE We evaluated the association of glycemic control with erectile dysfunction in men with diabetes type 2. MATERIALS AND METHODS A convenience sample of men with diabetes type 2 at the Cleveland Veterans Affairs Medical Center completed questions 1 to 5 of the International Index of Erectile Function. The primary outcome measure was erectile function score, calculated as the sum of questions 1 to 5. Details of disease duration, complications, medication use, patient age and level of glycosylated hemoglobin were obtained by reviewing the medical record. RESULTS Mean subject age plus or minus standard deviation was 62.0+/-12.3 years, mean hemoglobin A1c was 8.1%+/-1.9% and mean erectile function score was 16.6+/-5.9 (range 5 to 23). Stratified analysis revealed that mean erectile function score decreased as hemoglobin A1c increased (analysis of variance p = 0.002). The test for linearity was also significant (p = 0.001). There were no statistically significant associations of levels of glycemic control with alpha-blocker, beta-blocker or diuretic use. Bivariate analysis showed a significant correlation of hemoglobin A1c with neuropathy but not with patient age, duration of diabetes, alpha-blockers, beta-blockers or diuretics. Multivariate analysis demonstrated that hemoglobin A1c was an independent predictor of erectile function score (p<0.001) even after adjusting for peripheral neuropathy, which was also an independent predictor (p = 0.023). CONCLUSIONS Our data add to the growing body of literature suggesting that erectile dysfunction correlates with the level of glycemic control. Peripheral neuropathy and hemoglobin A1c but not patient age were independent predictors of erectile dysfunction.

An Overnight High-Dose Dexamethasone Suppression Test for Rapid Differential Diagnosis of Cushing's Syndrome

We have developed a high-dose dexamethasone suppression test that can be administered overnight with a single 8-mg dose and used the new procedure in the differential diagnosis of 83 patients with Cushings syndrome. In 76 patients with surgically or pathologically proven cause--60 with Cushings disease, 7 with the ectopic adrenocorticotrophic hormone syndrome, and 9 with adrenal tumors--suppression of plasma cortisol levels to less than 50% of baseline indicated a diagnosis of Cushings disease. The test had a sensitivity of 92%, a specificity of 100%, and a diagnostic accuracy of 93%. These values equal or exceed those of the standard 2-day test whether based on suppression of urinary 17-hydroxycorticosteroids or plasma cortisol. We conclude that this overnight, high-dose dexamethasone suppression test is practical and reliable in the differential diagnosis of Cushings syndrome.

Selective Venous Sampling for ACTH in Cushing's Syndrome: Differentiation Between Cushing's Disease and the Ectopic ACTH Syndrome

We performed selective venous catheterization and sampling for ACTH in six patients with ACTH-secreting pituitary adenomas (Cushings disease) and four patients with occult ectopic ACTH-secreting neoplasms. In five patients with Cushings disease in whom the inferior petrosal sinus could be catheterized, ACTH levels were unequivocally higher than simultaneous peripheral values: The ratio was greater than 2.0, with a range of 2.2 to 16.7. In contrast, the inferior petrosal sinus-to-peripheral ACTH ratio in three patients with ectopic ACTH secretion was less than 1.5. In the fourth patient, an arteriovenous gradient of 6.8 was shown 2 years before a bronchial carcinoid tumor was clinically apparent. Central-to-peripheral ACTH ratios at the level of the jugular bulb and jugular vein were not diagnostic. We conclude that selective venous ACTH sampling from the inferior petrosal sinus is a reliable and useful aid in the differential diagnosis of Cushings syndrome when standard clinical and biochemical studies are inconclusive.

Shared medical appointments based on the chronic care model: a quality improvement project to address the challenges of patients with diabetes with high cardiovascular risk

Objective: The epidemic proportions and management complexity of diabetes have prompted efforts to improve clinic throughput and efficiency. One method of system redesign based on the chronic care model is the Shared Medical Appointment (SMA) in which groups of patients (8–20) are seen by a multi-disciplinary team in a 1–2 h appointment. Evaluation of the impact of SMAs on quality of care has been limited. The purpose of this quality improvement project was to improve intermediate outcome measures for diabetes (A1c, SBP, LDL-cholesterol) focusing on those patients at highest cardiovascular risk. Setting: Primary care clinic at a tertiary care academic medical center. Subjects: Patients with diabetes with one or more of the following: A1c >9%, SBP blood pressure >160 mm Hg and LDL-c >130 mg/dl were targeted for potential participation; other patients were referred by their primary care providers. Patients participated in at least one SMA from 4/05 to 9/05. Study design: Quasi-experimental with concurrent, but non-randomised controls (patients who participated in SMAs from 5/06 through 8/06; a retrospective period of observation prior to their SMA participation was used). Intervention: SMA system redesign Analytical methods: Paired and independent t tests, χ2 tests and Fisher Exact tests. Results: Each group had up to 8 patients. Patients participated in 1–7 visits. At the initial visit, 83.3% had A1c levels >9%, 30.6% had LDL-cholesterol levels >130 mg/dl, and 34.1% had SBP ⩾160 mm Hg. Levels of A1c, LDL-c and SBP all fell significantly postintervention with a mean (95% CI) decrease of A1c 1.4 (0.8, 2.1) (p<0.001), LDL-c 14.8 (2.3, 27.4) (p = 0.022) and SBP 16.0 (9.7, 22.3) (p<0.001). There were no significant differences at baseline between control and intervention groups in terms of age, baseline intermediate outcomes, or medication use. The reductions in A1c in % and SBP were greater in the intervention group relative to the control group: 1.44 vs –0.30 (p = 0.002) for A1c and 14.83 vs 2.54 mm Hg (p = 0.04) for SBP. LDL-c reduction was also greater in the intervention group, 16.0 vs 5.37 mg/dl, but the difference was not statistically significant (p = 0.29). Conclusions: We were able to initiate a programme of group visits in which participants achieved benefits in terms of cardiovascular risk reduction. Some barriers needed to be addressed, and the operations of SMAs evolved over time. Shared medical appointments for diabetes constitute a practical system redesign that may help to improve quality of care.

Secretion of insulinlike growth factor I and insulinlike growth factor-binding proteins by murine bone marrow stromal cells.

Insulin-like growth factor I (IGF-I) stimulates hematopoiesis. We examined whether bone marrow stromal cells synthesize IGF-I. Secretion of IGF-I immunoreactivity by cells from TC-1 murine bone marrow stromal cells was time-dependent and inhibited by cycloheximide. Gel filtration chromatography under denaturing conditions of TC-1 conditioned medium demonstrated two major peaks of apparent IGF-I immunoreactivity with molecular weights of approximately 7.5-8.0 kD, the size of native IGF-I, and greater than 25 kD. Expression of IGF-I mRNA was identified by both RNase protection assay and reverse transcription/polymerase chain reaction. To determine whether the greater than 25-kD species identified by RIA possessed IGF-binding activity, a potential cause of artifactual IGF-I immunoreactivity, charcoal adsorption assay of these gel filtration fractions was performed. The peak of IGF-binding activity coeluted with apparent IGF-I immunoreactivity suggesting that TC-1 cells secrete IGF-binding protein(s). Unfractionated conditioned medium exhibited linear dose-dependent increase in specific binding of [125I]-IGF-I with a pattern of displacement (IGF-I and IGF-II much greater than insulin) characteristic of IGF-binding proteins. Western ligand analysis of conditioned medium showed three IGF-I binding species of approximately 31, 38, and 40 kD. These data indicate that TC-1 bone marrow stromal cells synthesize and secrete IGF-I and IGF-binding proteins and constitute a useful model system to study their regulation and role in hematopoiesis.

Cushing's syndrome: Problems in diagnosis

Cushings syndrome, an unusual group of disorders characterized by hypercortisolism, must be considered in the differential diagnosis of such common clinical problems as hirsutism, menstrual irregularity, hypertension, diabetes mellitus, and obesity. Its distinct forms--pituitary-dependent Cushings syndrome (Cushings disease), adrenal tumor and ectopic ACTH syndrome--must be identified correctly so that specific therapy can be administered. In the majority of cases, use of a relatively simple diagnostic sequence will provide accurate and rapid diagnosis. However, in our experience with more than 60 patients, diagnostic difficulties may arise from a variety of conditions (e.g., drug interference, alcohol ingestion, and depression). In addition, unusual circumstances, such as unexpected responses to dexamethasone, may complicate the diagnosis. Our approach to these problems is illustrated through a report of seven cases, and we emphasize that the proper management of Cushings syndrome mandates a thorough marshalling of all the available data.

Assessing Potential Glycemic Overtreatment in Persons at Hypoglycemic Risk

IMPORTANCE Although serious hypoglycemia is a common adverse drug event in ambulatory care, current performance measures do not assess potential overtreatment. OBJECTIVE To identify high-risk patients who had evidence of intensive glycemic management and thus were at risk for serious hypoglycemia. DESIGN, SETTING, AND PARTICIPANTS Cross-sectional study of patients in the Veterans Health Administration receiving insulin and/or sulfonylureas in 2009. MAIN OUTCOMES AND MEASURES Intensive control was defined as the last hemoglobin A1c (HbA1c) measured in 2009 that was less than 6.0%, less than 6.5%, or less than 7.0%. The primary outcome measure was an HbA1c less than 7.0% in patients who were aged 75 years or older who had a serum creatinine value greater than 2.0 mg/dL or had a diagnosis of cognitive impairment or dementia. We also assessed the rates in patients with other significant medical, neurologic, or mental comorbid illness. Variation in rates of possible glycemic overtreatment was evaluated among 139 Veterans Health Administration facilities grouped within 21 Veteran Integrated Service Networks. RESULTS There were 652,378 patients who received insulin and/or a sulfonylurea with an HbA1c test result. Fifty percent received sulfonylurea therapy without insulin; the remainder received insulin therapy. We identified 205,857 patients (31.5%) as the denominator for the primary outcome measure; 11.3% had a last HbA1c value less than 6.0%, 28.6% less than 6.5%, and 50.0% less than 7.0%. Variation in rates by Veterans Integrated Service Network facility ranged 8.5% to 14.3%, 24.7% to 32.7%, and 46.2% to 53.4% for HbA1c less than 6.0%, less than 6.5%, and less than 7.0%, respectively. The magnitude of variation by facility was larger, with overtreatment rates ranging from 6.1% to 23.0%, 20.4% to 45.9%, and 39.7% to 65.0% for HbA1c less than 6.0%, less than 6.5%, and less than 7.0%, respectively. The maximum rate was nearly 4-fold compared with the minimum rates for HbA1c less than 6.0%, followed by 2.25-fold for HbA1c less than 6.5% and less than 2-fold for HbA1c less than 7.0%. When comorbid conditions were included, 430,178 patients (65.9%) were identified as high risk. Rates of overtreatment were 10.1% for HbA1c less than 6.0%, 25.2% for less than 6.5%, and 44.3% for less than 7.0%. CONCLUSIONS AND RELEVANCE Patients with risk factors for serious hypoglycemia represent a large subset of individuals receiving hypoglycemic agents; approximately one-half had evidence of intensive treatment. A patient safety indicator derived from administrative data can identify high-risk patients for whom reevaluation of glycemic management may be appropriate, consistent with meaningful use criteria for electronic medical records.