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PubMed2002

Evaluation of the Society for Coronary Angiography and Interventions' lesion classification system in 14,133 patients with percutaneous coronary interventions in the current stent era.

We recently showed that the ACC/AHA coronary lesion classification could be simplified with no loss of predictive value (SCAI I = patent/non-C; SCAI II = patent/C; SCAI III = occluded/non-C; SCAI IV = occluded/C). We now test this system in a database reflecting current stent usage. Data from 14,133 patients with single-native-vessel interventions recorded in the Society for Coronary Angiography and Interventions (SCAI) Registry from July 1996 to July 1999 were analyzed. Stents were used in 60.2% of procedures. Logistic models predicting angiographic success suggested a slight, clinically insignificant preference for the SCAI classification (c-statistic = 0.692 vs. 0.670). Models using clinical variables to predict major complications were superior to models using only lesion classification. Lesion characteristics were related to outcomes primarily in elective (not acute myocardial infarction) patients. In the current PCI device era, the simpler SCAI classification using 7 variables predicted interventional success and complications as well as or better than the ACC/AHA system requiring 26.

Aged↗
PubMed2002

Interventions to facilitate social interaction for young children with autism: review of available research and recommendations for educational intervention and future research.

The purpose of this paper is to review the knowledge available from aggregated research (primarily through 2000) on the characteristics of social interactions and social relationships among young children with autism, with special attention to strategies and tactics that promote competence or improved performance in this area. In its commissioning letter for the initial version of this paper, the Committee on Educational Interventions for Children with Autism of the National Research Council requested "a critical, scholarly review of the empirical research on interventions to facilitate the social interactions of children with autism, considering adult-child interactions (where information is available) as well as child-child interactions, and including treatment of [one specific question]: What is the empirical evidence that social irregularities of children with autism are amenable to remediation?" To do this, the paper (a) reviews the extent and quality of empirical literature on social interaction for young children with autism; (b) reviews existing descriptive and experimental research that may inform us of relations between autism and characteristics that support social development, and efforts to promote improved social outcomes (including claims for effectiveness for several specific types of intervention); (c) highlights some possible directions for future research; and (d) summarizes recommendations for educational practices that can be drawn from this research.

Autistic Disorder↗
PubMed2001

Cost-effectiveness analysis of intravascular ultrasound guided percutaneous coronary intervention versus conventional percutaneous coronary intervention.

OBJECTIVE: Investigation of the cost-effectiveness of intravascular ultrasound (IVUS) guided percutaneous coronary intervention (PCI) compared to PCI guided by coronary angiography (CAG). METHODS: One hundred and eight men referred for PCI, were randomized to IVUS or CAG guided PCI. After 6 months, the patients were subjected to a study related clinical and invasive follow-up investigation by CAG, IVUS and intracoronary Doppler flow measurements. Incremental costs of IVUS guided procedures and costs of re-interventions were estimated using the Activity Based Costing (ABC) method. RESULTS: Patients randomized to IVUS guided PCI experienced an improved clinical outcome, with lower angina levels than patients in the CAG guided group. The initial cost of performing IVUS guidance was increased due to extra procedure time, IVUS catheters and slightly more balloons and stents, but fewer patients in the IVUS guided group needed re-intervention. Overall, these savings outweighed the initial cost increase. CONCLUSION: Our data suggest that when performing IVUS guided PCI, costs as well as benefits increase. The increased benefits measured as cost savings resulting from less restenosis outweigh the cost increase from performing the IVUS guided PCI as opposed to CAG guided PCI.

Adult↗
PubMed1997

Psychosocial intervention following suicide attempt: a systematic review of treatment interventions.

Repeated suicide attempts are a common problem. However, few randomized controlled studies on the treatment of suicide attempters have been described. Although some of these studies showed beneficial effects on measures of well-being, none of them demonstrated lasting positive effects on repeated suicidal behaviour. In an attempt to analyse the results obtained, a systematic review of randomized controlled trials of interventions for suicide attempters is presented. The literature was gathered by means of a CD-ROM literature reference search (MEDLINE/PSYCLIT). Subsequently, information on study design and treatment efficacy was abstracted. Studies that were homogeneous with regard to therapeutic principles were reviewed accordingly, and pooled analyses were performed. Meta-analyses accounted for inter-study variance (random-effects model) to estimate a common-effect measure (relative risk). Systematic review of the data showed considerable differences in both study design and therapeutic protocols. In view of these differences, a single pooled analysis of all studies appeared to be unfeasible. A pooled analysis of studies that focus on psychiatric management of poor compliance showed no significant effect on the repetition of suicide attempts. Similarly, studies of psychosocial crisis intervention, as well as studies of guaranteed in-patient shelter in cases of emergency, did not show a significant reduction in repeated suicide attempts. However, the pooled results of four studies on cognitive-behavioural therapies showed a significant preventive effect on repeated suicide attempts. At present, only the cognitive-behavioural approach appears to have a beneficial effect on repeated suicide attempts. However, because of methodological variability, the results obtained may be too optimistic. Additional research is required to establish the merits of this type of intervention.

Analysis of Variance↗
PubMed2002

Standards for reporting interventions in controlled trials of acupuncture: The STRICTA recommendations. STandards for Reporting Interventions in Controlled Trails of Acupuncture.

Acupuncture treatment and control group interventions in parallel-group randomised trials of acupuncture are not always precisely reported. In an attempt to improve standards, an international group of experienced acupuncturists and researchers devised a set of recommendations, designating them STRICTA: STandards for Reporting Interventions in Controlled Trials of Acupuncture. In a further consensus-building round, the editors of several journals helped redraft the recommendations. These follow the Consolidated Standards for Reporting Trials (CONSORT) format, acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies. Participating journal editors are publishing the STRICTA recommendations and requesting prospective authors to adhere to them when preparing reports for publication. Other journals are invited to adopt these recommendations. The intended outcome is that interventions in controlled trials of acupuncture will be more adequately reported, thereby facilitating an improvement in critical appraisal, analysis and replication of trials.

Acupuncture Therapy↗
PubMed2000

Sedation, analgesia and anesthesia for interventional radiological procedures in adults. Part II. Recommendations for interventional radiologists.

Benzodiazepines are given orally as a premedication before an interventional radiological procedure. Local analgesia is achieved by drugs such as lidocaine, bupivacaine or ropivacaine. General analgesia is obtained by non opioid analgesics and opioid narcotics. For intravenous sedation, benzodiazepines such as ketamine or propofol should be administered under the supervision of an anesthesiologist. A preprocedure consultation with the anesthesiologist is recommended. Monitoring equipments, drugs and nursing staff assistance should be provided in the interventional suite. Vital signs should be monitored for several hours until patient's discharge. Close collaboration between anesthesiologists and interventional radiologists is a prerequisite for achieving high standard sedation and analgesia.

Adult↗
PubMed2001

Interventions for herpes simplex virus epithelial keratitis.

BACKGROUND: Many clinical trials have been performed on the acute treatment of dendritic epithelial keratitis. Surveys of antiviral pharmacology and of herpes simplex virus eye disease have evaluated different commercially available agents, but a systematic review of all comparative clinical studies has not previously been undertaken. OBJECTIVES: The objective of this review is to compare the effects of various treatments for dendritic or geographic herpes simplex virus epithelial keratitis. SEARCH STRATEGY: Sources searched for relevant studies were the Cochrane Eyes and Vision Group specialized register, The Cochrane Controlled Trials Register - CENTRAL, MEDLINE, EMBASE, Index Medicus, Excerpta Medica Ophthalmology, reference lists of primary reports, review articles, and corneal textbooks and conference proceedings pertaining to ocular virology. SELECTION CRITERIA: This review includes comparative clinical trials that assessed oral or topical ophthalmic antiviral agents, or physical or chemical debridement in people with active epithelial keratitis. DATA COLLECTION AND ANALYSIS: The reviewer extracted data and assessed trial quality. Interventions were compared by the proportions of participants healed at seven days and at fourteen days after trial enrollment. MAIN RESULTS: This review includes data from 96 trials which randomised a total of 4991 participants. Compared to idoxuridine, the topical application of vidarabine, trifluridine, or acyclovir generally resulted in a significantly greater proportion of participants healing within one week of treatment. Among these three antiviral agents, no treatment emerged as significantly better for the therapy of dendritic epithelial keratitis. Insufficient placebo-controlled studies were available to assess debridement and other physical and physicochemical methods of treatment. Interferon monotherapy had a slight beneficial effect on dendritic epithelial keratitis, but not better than other antiviral agents, and was useful with debridement. REVIEWER'S CONCLUSIONS: Currently available and investigational antiviral agents are effective and nearly equivalent, but the combination of an antiviral nucleoside and interferon seems to speed healing. Future trials of the acute treatment of herpes simplex virus epithelial keratitis must aim to achieve adequate statistical power for assessing the primary outcome and should consider the effect of lesion size and other characteristics on treatment response.

Administration, Oral↗
PubMed2002

Rescue percutaneous coronary intervention following coronary artery bypass graft--a descriptive analysis of the changing interface between interventional cardiologist and cardiac surgeon.

BACKGROUND: Despite decreasing rates of acute and subacute complications of percutaneous coronary intervention (PCI), these procedures are generally only performed in centers where it is possible for failed PCI to be treated by rescue coronary artery bypass graft (CABG). Case reports and case series have documented successful PCI following failed CABG. We sought to confirm this decrease in the need for rescue CABG following failed PCI and to examine trends in the utilization of rescue PCI following failed CABG. HYPOTHESIS: The interface between interventional cardiologist and cardiac surgeon is characterized by changing practice patterns and resource utilization. METHODS: We examined the medical records of all patients admitted to the Brigham and Women's Hospital over a 7-year period and identified 169 patients who required both PCI and CABG during the same hospital admission. We describe and compare three predetermined groups of patients defined by the sequence of, and indication for, the relevant myocardial revascularization procedures. RESULTS: In all, 100 patients required CABG for failed PCI, 46 patients had planned hybrid procedures involving both CABG and PCI, and 23 patients required PCI following failed CABG. There was a decrease in the need for rescue CABG following failed PCI, both in total numbers and as a percentage of total cases (2.5% in 1994 and 0.22% in 1999). There was a simultaneous increase in the utilization of rescue PCI following failed CABG (0% in 1994 and 1.6% in 2000). Hybrid procedures were identified as a source of innovative solutions to a variety of challenging clinical problems. CONCLUSIONS: Changing patterns of resource utilization should be considered when planning hospital facilities and patient triage, and these patients undergoing percutaneous or surgical revascularization may benefit from close cooperation between the cardiac surgeon and the interventional cardiologist.

Aged↗
PubMed1998

[First annual report of practitioners of interventional cardiology in private practice in Germany. Results of procedures of left heart catheterization and coronary interventions in the year 1996].

The German Society for Cardiac Angiography and Interventions in Private Practice has started a registry of cardiac procedures since 1996 in order to establish a standard for performance. Although quality management for the cath lab makes sense and is also legally required, there is no generally recommended infrastructure for quality assurance existing in Germany at this time. Therefore, the German Society of Cardiologists in Private Practice (BNK) initiated a project in 1994 to develop a computer program for paperless documentation of diagnostic cardiac catheterizations and coronary interventions (PTCA) using a minimal data set. In 1996, 8 private associated groups participated in this project. The (anonymous) analysis of 10,316 diagnostic cardiac catheterizations and 2597 PTCA yielded the following results: In 95% of the patients, diagnostic cardiac catheterization was performed using the femoral and in 5% the brachial/radial approach. The mean volume of administered contrast medium was 164 +/- 138 ml/patient. The mean LV-EF was greater than 50% in 58.4% of the patients and between 30% and 50% in 10.1%. Coronary artery disease was diagnosed in 69.6% of the patients and valvular/congenital heart disease in 8.5%. In 18.4% of the patients undergoing diagnostic cardiac catheterizations no significant heart disease was identified. Mortality in the cath lab as well as the rate of cerebral insults was 0.05%. In 22.9% and 19% of the patients PTCA and cardiac surgery respectively was recommended. In patients undergoing PTCA, stable angina was present in 74.4% and unstable angina in 13.1%. Of the total number of PTCA procedures, 5.8% were performed in the setting of acute myocardial infarction. The PTCA lesion success rate was 96%, the mean diameter stenosis was 81% pre and 6% post-intervention. The mortality rate at 1 month post-PTCA was 0.4%, and myocardial infarction 1.0%. An acute occlusion occurred in 1.3% of the PTCA patients; 0.6% had to be transferred for emergency bypass surgery. None of the cath labs had on-site surgery. In comparison to other registries, our data show some similarities but also some different trends. Thus, our newly developed software proved to be reliable, fast and easy to use. Participating centers receive immediate feedback regarding their position within the whole group.

Angiocardiography↗
PubMed2001

[Coronary intervention and occupational rehabilitation--a prospective, randomized intervention study].

Coronary catheter revascularisation is less costly than bypass surgery due to lower direct (medical) and indirect costs (loss of work). Many studies show that the time patients stay out of work following coronary intervention is much longer than necessary. This leads to a considerable increase of indirect costs, which can far exceed the medical costs of the treatment. This prospective randomised study was done to determine whether specific information to patient and family doctor results in an earlier return to work. After catheter revascularisation 100 working patients (mean age 52.4 years) were randomised either to the intervention group (information to patient and family doctor) or to the control group (no specific information about return to work). Four months later 81 patients had returned to their previous jobs (mean sick leave 18.9 +/- 24.8 days) while 19 were still out of work. In the control group, the rate was 79% and the mean sick leave was 16.4 +/- 22.0 days (median 7); in the intervention group 83% had returned to work after a mean of 21.5 +/- 27.4 days (median 10). There was no significant difference between the two groups, neither according to the rate of returned workers nor to the duration of sick leave. In the subgroup of patients with a private insurance (23% of all) 96% started to work again (mean sick leave 5.7 +/- 5.1 days median 3.5), while the rate was 77% in the group of panel patients (mean sick leave 23.7 +/- 27.4 days, median 11). The difference in sick leave between these two groups was highly significant (p = 0.0003). Specific information to the patient and family doctor has no effect on the time patients stay out of work following catheter revascularisation. It seems that the observed delay depends on social and psychological factors that cannot be influenced directly.

Absenteeism↗
PubMed1993

Trial of antihypertensive intervention and management: greater efficacy with weight reduction than with a sodium-potassium intervention.

The Trial of Antihypertensive Intervention and Management evaluated nine diet-drug combinations in 878 mildly hypertensive, moderately obese participants using a 3 x 3 factorial design. Drugs evaluated were placebo, diuretic (chlorthalidone), and beta-blocker (atenolol); diets were usual (no intervention), weight reduction, and low sodium/high potassium (Na/K). This article reports 6-month dietary changes and the effect of dietary change on blood pressure. Six-month mean weight change was -4.7 kg in the weight reduction group, -0.3 kg in the Na/K group, and -0.5 kg in the usual-diet group. At 6 months, daily electrolyte excretion had changed in the Na/K intervention group. Daily sodium excretion decreased from 138.0 to 112.0 mmol in the Na/K group and increased from 134.1 to 138.4 mmol in the weight reduction group and from 129.1 to 137.0 mmol in the usual-diet group. Daily potassium output increased from 58.7 to 71.4 mmol in the Na/K group, from 57.0 to 60.5 mmol in the weight reduction group, and from 55.3 to 59.1 mmol in the usual diet group. Analysis of 3-day food records indicated that sodium intake decreased from 141.1 to 85.8 mmol and potassium intake increased from 76.4 to 90.5 mmol. Our results indicate that the goal for weight reduction was more easily achieved than the goal for electrolyte modification.

Adult↗
PubMed1985

Exercise electrocardiogram and coronary heart disease mortality in the Multiple Risk Factor Intervention Trial. Multiple Risk Factor Intervention Trial Research Group.

The Multiple Risk Factor Intervention Trial (MRFIT), a coronary heart disease (CAD) primary prevention trial, examined the effect on the CAD mortality rate of a special intervention (SI) program to reduce blood cholesterol level, diastolic blood pressure and cigarette smoking in 35- to 57-year-old men. Half of the 12,866 participants were randomly assigned to usual care (UC) in the community. During 6 to 8 years of follow-up, the CAD mortality rate was 7% lower in the SI than in the UC group, a nonsignificant difference. An a priori subgroup hypothesis proposed that men with a normal electrocardiographic response to a heart-rate-limited exercise test would experience particular benefit from intervention. An abnormal response, defined as an ST-depression integral measured by computer greater than a pre-determined voltage-time cutpoint, was observed in 12.5% of the men at baseline, and was associated with a 3-fold elevation in risk of CAD death within the UC group. In the subgroup with a normal exercise electrocardiographic response, there was no significant SI-UC difference in the CAD mortality rate (16.0 and 13.8 per 1,000, respectively, for SI and UC men). In contrast, there was a 57% lower rate among men in the SI group with an abnormal test result compared with men in the UC group (22.2 vs 51.8 per 1,000). The relative risks (SI/UC) in these 2 strata were significantly different (p = 0.002). These findings suggest that men with elevated risk factors who have an abnormal exercise test response may benefit substantially from risk factor reduction.

Adult↗
PubMed2005

Neurocognitive functioning in patients undergoing coronary artery bypass graft surgery or percutaneous coronary intervention: evidence of impairment before intervention compared with normal controls.

BACKGROUND: Cognitive deficits have been reported to occur in a significant proportion of patients undergoing coronary artery bypass grafting (CABG), but the extent to which these deficits were preexistent or related to the natural history of cognitive decline in this patient population remains poorly defined. METHODS: After excluding patients with conditions known to cause brain dysfunction (eg, hepatic dysfunction, stroke), a group of patients referred for percutaneous coronary intervention (PCI) or CABG (n = 82) was compared with an age- and education-matched control group that did not have clinical evidence of coronary artery disease (n = 41). These subjects underwent a battery of neurocognitive and emotional testing. RESULTS: Test score means for 5 of 14 different measures were significantly greater (impaired) in cardiac compared with control group subjects. Of cardiac subjects, 20% demonstrated clinical impairment (test result > or = 1 SD worse than mean for normative standards) in 6 of 14 tests, compared with 10% of the controls. By clinical standards, 46% of cardiac subjects would be considered to be impaired (score 1 SD or more below the control group mean) on 3 or more neuropsychologic measures, compared with 29% of the controls. By this (control group mean) standard, cardiac subjects demonstrated impaired scores on 3.06 +/- 2.6 tests compared with impairment in 2.0 +/- 2.35 tests for the control group (p = 0.01). CONCLUSIONS: Even excluding patients at high risk for brain dysfunction, cognitive impairment is found in patients with coronary artery disease before interventional therapy. Baseline impairment must be considered when evaluating outcomes after intervention.

Aged↗
PubMed2003

Evaluation of the American College of Cardiology/American Heart Association and the Society for Coronary Angiography and Interventions lesion classification system in the current "stent era" of coronary interventions (from the ACC-National Cardiovascular Data Registry).

In 1988 American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for Coronary Angioplasty proposed a lesion classification system to stratify lesions by difficulty and risk to better understand the outcomes of coronary interventions. It was a 3-level (A, B, and C) classification based on 11 lesion characteristics. A modification, dividing the intermediate B category into B1 and B2, is also in common use. Recently, a simplification of this classification was evaluated using the large Society for Cardiac Angiography and Interventions (SCAI) Registry (SCAI I = non-C/patent; SCAI II = C/patent; SCAI III = non-C/occluded; SCAI IV = C/occluded). The lesion classification systems were evaluated in 61,926 patients from the ACC National Cardiovascular Data Registry who underwent single-vessel percutaneous coronary intervention between January 1998 and September 2000. Stents were placed in 74.5% of patients. Logistic models for lesion success and complications were constructed and compared. The c statistic for success using the ACC/AHA original classification system was 0.69, 0.71 for the modified ACC/AHA system, and 0.75 for the SCAI classification. The range of complication and success rates was greater using the SCAI models, and the logistic models for success and complication were more robust for the SCAI system. Thus, in the large ACC-National Cardiovascular Data Registry, with a high percentage of stent usage, the simpler SCAI lesion classification provided better discrimination for success and complications than the more complex ACC/AHA lesion classification system-original or modified.

Angioplasty, Balloon, Coronary↗
PubMed2000

Adherence to pharmacological interventions. Current trends and future directions. The Pharmacological Intervention Working Group.

The complexity of adherence to pharmacological interventions is frequently underestimated. Consequently, little research has been done to understand, improve, or evaluate the effects of adherence to drug protocols. While efforts to better measure and increase adherence require dedicated resources, improved adherence in existing clinical research can potentially cut costs in trial size and length. This paper outlines strategies to facilitate research on adherence to pharmacological interventions including: reporting of adherence data, changing how we conceptualize adherence to pharmaceuticals, understanding issues unique to older adults' pill-taking behavior, and creating standardized methodologies to measure adherence. Further, we describe some promising research areas that may lead to effective interventions: adherence "typologies" and modality matching. Control Clin Trials 2000;21:218S-225S

Aged↗
PubMed2000

Developmental outcome, child behaviour and mother-child interaction at 3 years of age following Newborn Individualized Developmental Care and Intervention Program (NIDCAP) intervention.

The aim of the present pilot study was to investigate the impact of early intervention in the form of family-centred developmentally supportive care according to NIDCAP((R)) (Newborn Individualized Developmental Care and Assessment Program) on the development and behaviour of the child and on the mother-child interaction at 3 years of age. Two groups of very-low-birth-weight (VLBW) infants (< or = 1500 g) were studied. The control group (n=21) was born in 1990, i.e. prior to implementation of the NIDCAP. The intervention group, born in 1992-1993 (n=21), was subjected to formal NIDCAP observation once every 10 days. Development was assessed using the Griffiths' Developmental Scale II in conjunction with a neurological examination. Behaviour was assessed on the basis of a parental interview. Mother-child interaction was assessed according to the Parent-Child Early Relational Assessment Scale (ERA). There was no significant difference in motor development. The total developmental quotient (DQ) on the Griffiths' developmental scale was 109 (94-122) [median (range)] for the NIDCAP group and 108 (93-120) for the control group (n.s.). On the subscale hearing-speech, the intervention group scored 119 (72-157) and the control group 108 (84-130) (P=0.02). The total score with respect to the Behaviour Symptom Interview was 6 (0-20) for the NIDCAP group and 16 (0-54) for the control group (P=0.03). With respect to the mother-child interaction, there was a significant difference in the child cluster 'communication', the total score being 12 (11-13) for the NIDCAP group and 10 (9-13) for the control group (P=0.03). In conclusion, care of VLBW infants according to NIDCAP appears to have certain positive long-term effects on the child's behaviour and mother-child interaction.

Adult↗
PubMed2002

Intervention strategies and risk-factor modification for falls prevention. A review of recent intervention studies.

At least 21 randomized trials of falls-prevention interventions have been published in the past 10 years; thus, many falls clearly can be prevented. The most effective interventions are those that target community-dwelling people who are at high risk for falling. There is no doubt that for this group multifactor intervention is effective. Convincing evidence that exercise can prevent falls does exist, but the best type of exercise remains uncertain. Tai Chi, intensive strength and endurance training, and home-based exercises prescribed by a physiotherapist seem promising. Reducing the use of psychotropic medications does prevent falls, but the value of home modifications is still unclear.

Accidental Falls↗
PubMed1997

Lung cancer mortality after 16 years in MRFIT participants in intervention and usual-care groups. Multiple Risk Factor Intervention Trial.

PURPOSE: The Multiple Risk Factor Intervention Trial (MRFIT), a randomized clinical trial for the primary prevention of coronary heart disease, enrolled 12,866 men (including 8194 cigarette smokers) aged 35-57 years at 22 clinical centers across the United States. Participants were randomized either to special intervention (SI), which included an intensive smoking cessation program, or to usual care (UC). After 16 years of follow-up, lung cancer mortality rates were higher in the SI than in the UC group. Since rates of smoking cessation in SI were higher than those for UC for the 6 years of the trial, and since risk of lung cancer mortality is known to decline with smoking cessation, these results were unexpected. The purpose of the present study was to investigate hypotheses that could explain the higher observed lung cancer mortality rates in the SI as compared with the UC group. METHODS: Analytic methods were employed to determine whether SI and UC participants differed either in baseline characteristics or in characteristics that changed during the trial and to determine whether these differences could explain the higher rates of lung cancer mortality among SI as compared to UC participants. Rates of mortality from coronary heart (CHD) were examined to explore the possibility that prevention of CHD death may have contributed to greater mortality due to lung cancer in the SI group. RESULTS: From randomization through December 1990, 135 SI and 117 UC participants died from lung cancer. The relative difference between the SI and U groups adjusted for age and number of cigarettes smoked per day, was 1.17 (95% CI:0.92-1.51). The greatest difference between the SI and UC groups in lung cancer mortality rates occurred among the heaviest smokers at baseline who did not achieve sustained smoking cessation by year 2. In this group the rates of death from CHD were approximately the same among the SI and UC subjects. No differences in baseline characteristics were found between SI and UC smokers who did not achieve sustained cessation by year 2, and there were no differences in follow-up characteristics between the two study groups that could explain the difference in lung cancer mortality. CONCLUSIONS: None of the hypotheses proposed to explain the unexpected higher rates of lung cancer mortality among SI as compared with UC subjects were sustained by the data. Thus we conclude that the difference observed is due to chance, and that a longer period of sustained smoking cessation plus follow-up is necessary to detect a reduction in lung cancer mortality as a result of smoking cessation intervention in a randomized clinical trial.

Adult↗