Optical Coherence Tomography-Guided versus Angiography-Guided PCI.

BACKGROUND: Data regarding clinical outcomes after optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) as compared with angiography-guided PCI are limited. METHODS: In this prospective, randomized, single-blind trial, we randomly assigned patients with medication-treated diabetes or complex coronary-artery lesions to undergo OCT-guided PCI or angiography-guided PCI. A final blinded OCT procedure was performed in patients in the angiography group. The two primary efficacy end points were the minimum stent area after PCI as assessed with OCT and target-vessel failure at 2 years, defined as a composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization. Safety was also assessed. RESULTS: The trial was conducted at 80 sites in 18 countries. A total of 2487 patients underwent randomization: 1233 patients were assigned to undergo OCT-guided PCI, and 1254 to undergo angiography-guided PCI. The minimum stent area after PCI was 5.72±2.04 mm2 in the OCT group and 5.36±1.87 mm2 in the angiography group (mean difference, 0.36 mm2; 95% confidence interval [CI], 0.21 to 0.51; P<0.001). Target-vessel failure within 2 years occurred in 88 patients in the OCT group and in 99 patients in the angiography group (Kaplan-Meier estimates, 7.4% and 8.2%, respectively; hazard ratio, 0.90; 95% CI, 0.67 to 1.19; P = 0.45). OCT-related adverse events occurred in 1 patient in the OCT group and in 2 patients in the angiography group. Stent thrombosis within 2 years occurred in 6 patients (0.5%) in the OCT group and in 17 patients (1.4%) in the angiography group. CONCLUSIONS: Among patients undergoing PCI, OCT guidance resulted in a larger minimum stent area than angiography guidance, but there was no apparent between-group difference in the percentage of patients with target-vessel failure at 2 years. (Funded by Abbott; ILUMIEN IV: OPTIMAL PCI ClinicalTrials.gov number, NCT03507777.).

Optical coherence tomography predictors of clinical outcomes after stent implantation: the ILUMIEN IV trial.

BACKGROUND AND AIMS: Observational registries have suggested that optical coherence tomography (OCT) imaging-derived parameters may predict adverse events after drug-eluting stent (DES) implantation. The present analysis sought to determine the OCT predictors of clinical outcomes from the large-scale ILUMIEN IV trial. METHODS: ILUMIEN IV was a prospective, single-blind trial of 2487 patients with diabetes or high-risk lesions randomized to OCT-guided versus angiography-guided DES implantation. All patients underwent final OCT imaging (blinded in the angiography-guided arm). From more than 20 candidates, the independent OCT predictors of 2-year target lesion failure (TLF; the primary endpoint), cardiac death or target-vessel myocardial infarction (TV-MI), ischaemia-driven target lesion revascularization (ID-TLR), and stent thrombosis were analysed by multivariable Cox proportional hazard regression in single treated lesions. RESULTS: A total of 2128 patients had a single treated lesion with core laboratory-analysed final OCT. The 2-year Kaplan-Meier rates of TLF, cardiac death or TV-MI, ID-TLR, and stent thrombosis were 6.3% (n = 130), 3.3% (n = 68), 4.3% (n = 87), and 0.9% (n = 18), respectively. The independent predictors of 2-year TLF were a smaller minimal stent area (per 1 mm2 increase: hazard ratio 0.76, 95% confidence interval 0.68-0.89, P < .0001) and proximal edge dissection (hazard ratio 1.77, 95% confidence interval 1.20-2.62, P = .004). The independent predictors of cardiac death or TV-MI were smaller minimal stent area and longer stent length; of ID-TLR were smaller intra-stent flow area and proximal edge dissection; and of stent thrombosis was smaller minimal stent expansion. CONCLUSIONS: In the ILUMIEN IV trial, the most important OCT-derived post-DES predictors of both safety and effectiveness outcomes were parameters related to stent area, expansion and flow, proximal edge dissection, and stent length.

Effects of explicit teacher-implemented phoneme awareness instruction in 4-year-olds.

The purpose of this study was to determine whether gains would be observed in an integrated group of 4-year-olds when phoneme awareness skills were explicitly taught by trained early childhood educators. In a quasi-experimental design with a delayed treatment approach, one classroom (N = 14) was randomly assigned to receive the instructional program in fall, while a second classroom (N = 10) served as a control and subsequently received the program in spring. Baseline assessment of speech and language skills indicated there were four participants with speech and/or language impairments. The teacher training involved an initial workshop and weekly hour-long mentoring meetings; the program was provided for 20 min a day, 4 d a week, for 10 weeks. Outcome measures of phoneme awareness and letter knowledge skills were obtained from non-standardized tasks administered pre-instruction and post-instruction, at mid-year and end-year points. When each classroom received the phoneme instruction, participants made gains in letter knowledge and phoneme level skills in comparison with group performance under regular instruction. These gains were statistically significant for phoneme blending and letter knowledge. Using an aggregate of all outcome measures, the gain for each classroom when under instruction was statistically significant as compared with when that same classroom was receiving the regular curriculum. Children with speech and/or language impairment responded more variably. Gains in the more difficult phoneme awareness skill of blending suggest the potential for marked change with an intensive, explicit classroom instruction and hold promise for SLPs collaborating with preschool teachers to provide time-efficient PA instruction.

Ventricular assist device using a thoracotomy-based implant technique: Multi-Center Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy (HM3 SWIFT).

OBJECTIVES: The HeartMate 3 (Abbott) left ventricular assist device provides substantial improvement in long-term morbidity and mortality in patients with advanced heart failure. The Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study compares thoracotomy-based implantation clinical outcomes with standard median sternotomy. METHODS: We conducted a prospective, multicenter, single-arm study in patients eligible for HeartMate 3 implantation with thoracotomy-based surgical technique (bilateral thoracotomy or partial upper sternotomy with left thoracotomy). The composite primary end point was survival free of disabling stroke (modified Rankin score >3), or reoperation to remove or replace a malfunctioning device, or conversion to median sternotomy at 6-months postimplant (elective transplants were treated as a success). The primary end point (noninferiority, -15% margin) was assessed with >90% power compared with a propensity score-matched cohort (ratio 1:2) derived from the Multi-Center Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 continued access protocol. RESULTS: The study enrolled 102 patients between December 2020 and July 2022 in the thoracotomy-based arm at 23 North American centers. Follow-up concluded in December 2022. In the Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study group, noninferiority criteria was met (absolute between-group difference, -1.2%; Farrington Manning lower 1-sided 95% CI, -9.3%; P < .0025) and event-free survival was not different (85.0% vs 86.2%; hazard ratio, 1.01; 95% CI, 0.58-2.10). Length of stay with thoracotomy-based implant was longer (median, 20 vs 17 days; P = .03). No differences were observed for blood product utilization, adverse events (including right heart failure), functional status, and quality of life between cohorts. CONCLUSIONS: Thoracotomy-based implantation of the HeartMate 3 left ventricular assist device is noninferior to implantation via standard full sternotomy. This study supports thoracotomy-based implantation as an additional standard for surgical implantation of the HeartMate 3 left ventricular assist device.

OCT-Guided vs Angiography-Guided Coronary Stent Implantation in Complex Lesions: An ILUMIEN IV Substudy.

BACKGROUND: ILUMIEN IV was the first large-scale, multicenter, randomized trial comparing optical coherence tomography (OCT)-guided vs angiography-guided stent implantation in patients with high-risk clinical characteristics and/or complex angiographic lesions. OBJECTIVES: The authors aimed to specifically examine outcomes in the complex angiographic lesions subgroup. METHODS: From the original trial population (N = 2,487), high-risk patients without complex angiographic lesions were excluded (n = 514). Complex angiographic lesion characteristics included: 1) long or multiple lesions with intended total stent length ≥28 mm; 2) bifurcation lesion with intended 2-stent strategy; 3) severely calcified lesion; 4) chronic total occlusion; or 5) in-stent restenosis. The study endpoints were: 1) final minimal stent area (MSA); 2) 2-year composite of serious major adverse cardiovascular events (MACEs) (cardiac death, target-vessel myocardial infarction [MI], or stent thrombosis); and 3) 2-year effectiveness, defined as target-vessel failure (TVF), a composite of cardiac death, target-vessel MI, or ischemia-driven target-vessel revascularization. RESULTS: The postpercutaneous coronary intervention (PCI) MSA was larger in the OCT-guided (n = 992) vs angiography-guided (n = 981) group (5.56 ± 1.95 mm2 vs 5.26 ± 1.81 mm2; difference, 0.30; 95% CI: 0.14-0.47; P < 0.001). Compared with angiography-guided PCI, OCT-guided PCI resulted in a lower risk of serious MACE (3.1% vs 4.9%; HR: 0.63; 95% CI: 0.40-0.99; P = 0.04). TVF was not significantly different between groups (7.3% vs 8.8%; HR: 0.82; 95% CI: 0.59-1.12; P = 0.20). CONCLUSIONS: In complex angiographic lesions, OCT-guided PCI led to a larger MSA and reduced the serious MACE, the composite of cardiac death, target-vessel MI, or stent thrombosis, compared with angiography-guided PCI at 2 years, but did not significantly improve TVF. (Optical Coherence Tomography Guided Coronary Stent Implantation Compared to Angiography: A Multicenter Randomized Trial in PCI; NCT03507777).

Computer-based simulation as a teaching tool for residents treating patients with cancer-related pain crises.

CONTEXT: Residents often fail to escalate narcotics to ensure pain relief in patients with cancer because of fear of overdose. A computer simulation of patients in pain may provide a way to improve management without fear of harm. We developed a pain care simulation to train residents. STUDY DESIGN/MEASURES: Thirty-one residents trained on 2 to 3 consecutive simulated patients. Simulated cases were assigned variable tolerances to narcotics and starting pain scores. The goals of training were as follows: (1) rapid induction of pain relief, (2) measurement of pain response at appropriate times, and (3) early institution and escalation in care long-acting pain medication to ensure stable pain control for 48 hours. Seven reviewers judged graphical summaries of care and assessed if pain improved, worsened, or stayed the same. RESULTS: Thirty-one residents participated: 25 completed 3 simulations; 6 completed only 2. Sixty-eight percent improved from case 1 to 2; 90% improved by 3. The average pain score declined from 2.5 in case 1 to 1.9 in case 3 (P = .04). Rescue medication use declined from 37% for the first case to 23% by the third (P = .18). Reviewers' intraclass correlation for improved pain care was 0.821 (95% CI, 0.721-0.895). CONCLUSIONS: Residents improved using a pain treatment simulator. A graphical representation of pain scores more than 48 hours of care that provides a useful way to assess pain control. Lessons learned may translate into improved patient care.

Effects of training on a simulator of pain care on the quality of pain care for patients with cancer-related pain.

CONTEXT: A computer simulator of pain care provided an environment for residents to learn to (1) rapidly induce pain relief; (2) measure pain scores at appropriate time intervals; (3) use induction doses to estimate, early in care, the long-acting pain medication requirements; and (4) escalate long-acting agents to ensure a smooth and nonvarying pain-control curve. We studied whether lessons learned on the simulator translated into improved pain control for patients with cancer-related pain crises. STUDY DESIGN AND MEASURES: We compared pain scores for 48 hours in 2 groups: 20 patients admitted consecutively, solely because of an acute exacerbation of pain, prior to training our residents on a simulator and 20 patients post-training. Training at the beginning of an oncology rotation consisted of education about pain control followed by practice on simulated cases of patients with cancer-related pain crises. Outcome measures were average pain scores compared using linear regression and the frequency of using long-acting agents early in a patient's care. RESULTS: Pain control in the first 48 hours of care improved in the postintervention period; the slope of the pain scores actually increased in the preintervention period and declined in the postintervention period (P < .0005). Residents used long-acting agents early in patients' care in 35% (7/20) in the preperiod and 90% (18/20) in the postperiod (P < .001). CONCLUSIONS: Residents developed pain care treatment skills on a computer-based simulator that translated into improved control of acute, cancer-related pain.

Learning optimal opioid prescribing and monitoring: a simulation study of medical residents.

OBJECTIVE: Hospitalized patients often receive opioids. There is a lack of consensus regarding evidence-based guidelines or training programs for effective management of pain in the hospital. We investigated the viability of using an Internet-based opioid dosing simulator to teach residents appropriate use of opioids to treat and manage acute pain. MATERIALS AND METHODS: We used a prospective, longitudinal design to evaluate the effects of simulator training. In face-to-face didactic sessions, we taught 120 (108 internal medicine and 12 family medicine) residents principles of pain management and how to use the simulator. Each trainee completed 10 training and, subsequently, 5 testing trials on the simulator. For each trial, we collected medications, doses, routes and times of administration, pain scores, and a summary score. We used mixed-effects regression models to assess the impact of simulation training on simulation performance scores, variability in pain score trajectories, appropriate use of short- and long-acting opioids, and use of naloxone. RESULTS: Trainees completed 1582 simulation trials (M = 13.2, SD = 6.8), with sustained improvements in their simulated pain management practices. Over time, trainees improved their overall simulated pain management scores (b = 0.05, P < .01), generated lower pain score trajectories with less variability (b = -0.02, P < .01), switched more rapidly from short-acting to long-acting agents (b = -0.50, P < .01), and used naloxone less often (b = -0.10, P < .01). DISCUSSION AND CONCLUSIONS: Trainees translated their understanding of didactically presented principles of pain management to their performance on simulated patient cases. Simulation-based training presents an opportunity for improving opioid-based inpatient acute pain management.

Differences in triage thresholds for patients presenting with possible acute coronary syndromes: more than meets the eye.

BACKGROUND: Many studies have shown differences in cardiac care by racial/ethnic groups without accounting for institutional factors at the location of care. OBJECTIVE: Exploratory analysis of the effect of hospital funding status (public vs private) on emergency department (ED) triage decision making for patients with symptoms suggestive of acute coronary syndromes (ACSs) and on the likelihood of ED discharge for patients with confirmed ACS. STUDY DESIGN AND SETTING: Secondary analysis of data from a randomized controlled trial of 10,659 ED patients with possible ACS in five urban academic public and five private hospitals. The main outcome measures were the sensitivity and specificity of hospital admission for the presence of ACS at public and private hospitals and the adjusted odds of a patient with ACS not being hospitalized at public versus private hospitals. RESULTS: Of 10,659 ED patients, 1,856 had confirmed ACS. For patients with suspected ACS, triage decisions at private hospitals were considerably more sensitive (99 vs 96%; p<.001) but less specific (30 vs 48%; p<.001) than at public hospitals. The difference between hospital types persisted after adjustment for multiple patient-level and hospital-level characteristics. CONCLUSION: Significant differences in triage for patients with suspected ACS exist between public and private hospital EDs, even after adjustment for multiple patient demographic, clinical, and institutional factors. Further studies are needed to clarify the causes of the differences.

Missed hypothyroidism diagnosis uncovered by linking laboratory and pharmacy data.

BACKGROUND: Although diagnostic errors are important, they have received less attention than medication errors. Timely follow-up of abnormal laboratory test results represents a critical aspect of the diagnostic process, and failures at this step are a cause of delayed or missed diagnosis, resulting in suboptimal clinical outcomes and malpractice litigation. We linked laboratory and pharmacy databases to (1) explore the potential for linking laboratory and pharmacy databases to uncover diagnostic errors, and (2) determine the frequency of failed follow-up of elevated levels of thyroid-stimulating hormone (TSH). METHODS: We downloaded TSH test results for 2 consecutive years from a laboratory database and linked this database with a pharmacy database to screen for patients with TSH levels of 20 mU/mL or higher who were not receiving levothyroxine. Patients with elevated TSH levels lacking prescriptions were followed up by telephone and record review. RESULTS: During the 2-year period, 982 (2.7%) of 36 760 unique patients tested for TSH level had elevated TSH levels. Of these patients, 177 (18.0%) had no recorded levothyroxine prescriptions. We attempted to contact 177 patients with high TSH levels who were not taking thyroid medications and reached 123 (69.5%). Of the 123 patients we were able to reach, 12 in 2000 and 11 in 2001 were unaware of their abnormal test results or a diagnosis of hypothyroidism, representing 2.3% of 982 patients with elevated TSH levels. We were unable to reach another 54 patients (5.5% of the total number of patients with elevated TSH levels) by either telephone or mail. CONCLUSIONS: By linking laboratory and pharmacy databases, we uncovered patients who did not undergo follow-up for abnormal TSH results. Conservatively, there was no follow-up for abnormal TSH results in more than 2% of patients, and another 5% of patients were lost to follow-up and possibly unaware of their results. Uncovering patients with missed diagnosis illustrates a potential use of linking laboratory and pharmacy databases to identify vulnerabilities in the care system and improve patient safety.

Eliminating inpatient sliding-scale insulin: a reeducation project with medical house staff.

OBJECTIVE: We studied a systematic program to reeducate our medical house officers on how to manage inpatient hyperglycemia without the use of sliding-scale insulin (SSI). RESEARCH DESIGN AND METHODS: Patients admitted to the general medical service with diabetes or a blood glucose >140 mg/dl were included. HbA(1c) was measured in all patients, and therapy was modified if the HbA(1c) was >7.0%. For each 24 h on call, two house officers were responsible for all glucose management for their team's patients and rounded with a teaching endocrinologist twice daily for 2 weeks. Oral agent or insulin therapy was modified using blood glucoses and HbA(1c). All patients who required insulin therapy were treated with basal and bolus insulin, usually NPH and regular, adjusted twice daily. RESULTS: During 8 weeks, 88 patients were identified and 16 house officers were instructed. The mean duration of diabetes was 10.4 years. Mean HbA(1c) level was 8.7%, and 48% of patients had HbA(1c) >8%. All patients with HbA(1c) >7% had diabetes therapy intensified. Overall 80% had their diabetes therapy changed by discharge. Compared with 98 historical control subjects, significantly fewer study patients had episodes of hyperglycemia, and a subgroup followed for 12 months showed a decrease in HbA(1c) from 10.1 to 8%. CONCLUSIONS: Medical history, blood glucose, and HbA(1c) testing can effectively identify patients with inpatient hyperglycemia. Using direct ward-based teaching and a widely disseminated pocket set of guidelines, house officers can be taught to effectively and safely manage inpatient hyperglycemia without the use of SSI.

Characterizing the pain score trajectories of hospitalized adult medical and surgical patients: a retrospective cohort study.

Pain care for hospitalized patients is often suboptimal. Representing pain scores as a graphical trajectory may provide insights into the understanding and treatment of pain. We describe a 1-year, retrospective, observational study to characterize pain trajectories of hospitalized adults during the first 48 hours after admission at an urban academic medical center. Using a subgroup of patients who presented with significant pain (pain score >4; n = 7762 encounters), we characterized pain trajectories and measured area under the curve, slope of the trajectory for the first 2 hours after admission, and pain intensity at plateau. We used mixed-effects regression to assess the association between pain score and sociodemographics (age, race, and gender), pain medication orders (opioids, nonopioids, and no medications), and medical service (obstetrics, psychiatry, surgery, sickle cell, intensive care unit, and medicine). K-means clustering was used to identify patient subgroups with similar trajectories. Trajectories showed differences based on race, gender, service, and initial pain score. Patients presumed to have dissimilar pain experiences (eg, sickle vs obstetrical) had markedly different pain trajectories. Patients with higher initial pain had a more rapid reduction during their first 2 hours of treatment. Pain reduction achieved in the 48 hours after admission was approximately 50% of the initial pain, regardless of the initial pain. Most patients' pain failed to fully resolve, plateauing at a pain score of 4 or greater. Visualizing pain scores as graphical trajectories illustrates the dynamic variability in pain, highlighting pain responses over a period of observation, and may yield new insights for quality improvement and research.

Organizational and cultural changes for providing safe patient care.

OBJECTIVE: To describe an approach and experience with fostering a culture of patient safety. METHODS: (1) Organizational Change-The Department of Medicine established a patient safety committee (PSC) and charged it with reviewing adverse events. (2) Cultural Change-PSC sponsors and participants work to promote a culture of collaboration, study, learning, and prevention versus a culture of blame. (3) Collaboration-The PSC includes chief residents and members from medical informatics, nursing, pharmacy, quality assurance, risk management, and utilization management. (4) Evolution-The duties of the PSC progressed from merely learning from adverse event reports to implementing patient safety and quality improvement projects. (5) Standardization-The PSC uses standard definitions and procedures when reviewing cases of adverse events, and when conducting patient safety and quality improvement projects. RESULTS: (1) Developed an online adverse event reporting system, shortening the average report collection time by 2 days and increasing the number of adverse events reported. (2) Established a model for change using (a) safety rounds with residents, (b) e-mail safety alerts, and, in some cases, (c) decision alerts using electronic order entry. These changes in culture and capability led to improvements in care and improved financial results. CONCLUSIONS: Senior management support of a culture of learning and prevention and an organizational structure that promotes collaboration has provided an environment in which patient safety initiatives can flourish by providing not only safer and higher quality patient care but also a positive financial return on investment.

Decompensated heart failure: symptoms, patterns of onset, and contributing factors.

PURPOSE: To examine the time course, contributing factors, and patient responses to decompensated heart failure. METHODS: We studied consecutive patients admitted to a public general hospital with a diagnosis of heart failure. Using a timeline follow-back technique, a nurse interviewer administered a questionnaire shortly after admission, exploring knowledge of a heart failure diagnosis, the symptoms and time course of decompensation, and patient responses to worsening symptoms. RESULTS: Of 87 patients, 83 (95%) consented to be interviewed. Only 49 (59%) were aware of the diagnosis of heart failure. Symptoms associated with decompensation included dyspnea in 81 patients (98%), edema in 64 patients (77%), and weight gain in 34 patients (41%). Onset of worsening of these symptoms was noted a mean (+/- SD) of 12.4 +/-1.4 days before admission for edema, 11.3 +/-1.6 days for weight gain, and 8.4 +/- 0.9 days for dyspnea. Forty-two patients (57%) reported missing or skipping medication because of various factors, particularly missed outpatient appointments. CONCLUSION: Using a timeline follow-back interview, we identified a period of days to weeks between the onset of worsening symptoms and hospital admission for heart failure decompensation. This pattern suggests that there is a time window between symptom exacerbation and admission during which earlier access and intervention might prevent hospitalization in these patients. Medication lapses continue to be an important preventable cause of decompensation leading to admission.

3-(alphaR)-alpha-((2S,5R)-4-allyl-2,5-dimethyl-1-piperazinyl)-3-hydroxybenzyl)-N-alkyl-N-arylbenzamides: potent, non-peptidic agonists of both the micro and delta opioid receptors.

Opioid analgesics with both micro and delta opioid receptor activation represent a new approach to the treatment of severe pain with an improved safety profile. Compounds with this profile may exhibit strong analgesic properties due to micro agonism, with a reduced side effect profile resulting from delta agonism. Replacing the p-diethylamide of the known potent delta opioid receptor selective agonist BW373U86 with a m-diethylamide resulted in a compound with agonist activity at both the micro and delta opioid receptors. Modifying the amide to an N-methyl-N-phenylamide increased agonist potency at both receptors. A series of 3-(alphaR)-alpha-((2S,5R)-4-allyl-2,5-dimethyl-1-piperazinyl)-3-hydroxybenzyl)-N-alkyl-N-arylbenzamides have been made to explore the structure-activity relationship (SAR) around the N-methyl-N-phenylamide. Several potent agonists of both the micro and delta opioid receptors have been identified, including (+)-3-((alphaR)-alpha-((2S,5R)-4-allyl-2,5-dimethyl-1-piperazinyl)-3-hydroxybenzyl)-N-(4-fluorophenyl)-N-methylbenzamide (23), which has EC50 values of 0.67 and 1.1 nM at the micro (guinea pig ileum assay) and delta (mouse vas deferens assay) opioid receptors, respectively.

Mailings timed to patients' appointments: a controlled trial of fecal occult blood test cards.

BACKGROUND: Fecal occult blood testing (FOBT) programs cost-effectively reduce colon cancer mortality. To improve the rate of colon cancer screening with FOBT, we tested the effect of mailing FOBT cards timed to appointments on the rates of completion of FOBT. DESIGN: Controlled trial. SETTING/PARTICIPANTS: A total of 119 patients with primary care appointments scheduled in May or June 2000 for an urban, public hospital clinic that serves predominantly low-income, African Americans with chronic diseases. The patients in the study were selected by linking a quality improvement registry, the appointment system database, and an FOBT database to generate a list of clinic patients who had not completed an FOBT in the preceding year. INTERVENTION: Subjects were assigned to either a system of mailing FOBT cards and reminders 2 weeks prior to a scheduled appointment or usual care. MAIN OUTCOME MEASURES: The primary outcomes were the rate of screening at the index appointment and during the year beginning with the date of the index appointment. RESULTS: The rate of return of the FOBT cards during the year beginning with the index appointment was 40.7% for the intervention group compared to 5% for the usual care group (odds ratio [OR]=13.0, p <0.001). The difference was accounted for largely by increases in screening at the index appointment (35.6% compared to 3.3%, OR=16.0, p <0.001). CONCLUSIONS: Using computer databases to generate a list of patients due for FOBT and then mailing FOBT cards timed to a scheduled appointment significantly increased the rate of colon cancer screening. This may be an efficient approach to increasing colon cancer screening with FOBT.