Saul Shiffman

Patient compliance with paper and electronic diaries

Paper diaries are commonly used in health care and clinical research to assess patient experiences. There is concern that patients do not comply with diary protocols, possibly invalidating the benefit of diary data. Compliance with paper diaries was examined with a paper diary and with an electronic diary that incorporated compliance-enhancing features. Participants were chronic pain patients and they were assigned to use either a paper diary instrumented to track diary use or an electronic diary that time-stamped entries. Participants were instructed to make three pain entries per day at predetermined times for 21 consecutive days. Primary outcome measures were reported vs actual compliance with paper diaries and actual compliance with paper diaries (defined by comparing the written times and the electronically-recorded times of diary use). Actual compliance was recorded by the electronic diary. Participants submitted diary cards corresponding to 90% of assigned times (+/-15 min). However, electronic records indicated that actual compliance was only 11%, indicating a high level of faked compliance. On 32% of all study days the paper diary binder was not opened, yet reported compliance for these days exceeded 90%. For the electronic diary, the actual compliance rate was 94%. In summary, participants with chronic pain enrolled in a study for research were not compliant with paper diaries but were compliant with an electronic diary with enhanced compliance features. The findings call into question the use of paper diaries and suggest that electronic diaries with compliance-enhancing features are a more effective way of collecting diary information.

First Lapses to Smoking: Within-Subjects Analysis of Real-Time Reports.

Studies of smoking relapse and temptation episodes have relied on retrospective recall and confounded between- and within-subject variability. Real-time data on temptations and lapses to smoke were gathered using palm-top computers. We made within-subject comparisons of the initial lapse, a temptation episode, and base rate data obtained through randomly scheduled assessments. Negative affect discriminated all three situations, with lapses worse than temptations, and temptations worse than random situations. Participants attributed lapses to negative mood and smoking cues, whereas temptations were more often attributed to behavioral transitions. Participants were 12 times more likely to report coping in temptations than in lapses. However, only cognitive (vs. behavioral) coping strategies were effective. Lapses (vs. the other situations) were more likely to occur when smoking was permitted, when cigarettes were easily available, and in the presence of other smokers. The results have clinical implications, and the computerized monitoring methods may be applicable to an array of clinical research problems.

Smoking withdrawal symptoms in two weeks of abstinence.

In order to study trends in smoking withdrawal symptoms, 35 participants in a smoking cessation clinic completed four questionnaires daily for 2 weeks. The questionnaire dealt with a variety of symptoms which a factor analysis showed could be grouped into four factors: stimulation, desire to smoke, and physical and psychological symptoms. Changes were observed in reports of symptoms over days. Trend analyses found that each symptom group except stimulation showed significant patterns or changes as a function of days in abstinence. These symptom clusters were all found to have U-shaped functions. In addition, desire to smoke and psychological symptoms showed linear decreases as abstinence proceeded. Light and heavy smokers were found to differ in the pattern of reported stimulation.Ss who were totally abstinent reported less severe craving overall for cigarettes than those who only reduced their cigarette consumption by an average of 60%. Also, the craving of totally abstinentSs dropped off more sharply as abstinence proceeded. The import of these patterns and trends in withdrawal symptoms as a function of time is discussed.

The measurement of drug craving.

This paper reviews theoretical and methodological issues in the measurement of drug craving, with an emphasis on self-report assessment. Despite the important role that craving plays in many research and clinical settings, the way in which the construct is conceptualized and measured rarely receives sufficient attention. Issues pertinent to conceptualizing craving are identified. Because there is no single perfect measure of craving, it is essential that researchers understand the limitations of each measure. Measurement performance concerns that affect the validity of different measures are reviewed. Non-verbal assessment methods are also reviewed. Research factors that may help determine the optimal measures for a given study are highlighted. It is concluded that advances in assessment will proceed only when combined with additional research and a better theoretical understanding of craving.

The Nicotine Dependence Syndrome Scale: A multidimensional measure of nicotine dependence

We report the development of a new multidimensional questionnaire to measure nicotine dependence, based on Edwardss syndromal conceptualization of dependence. We present three studies. In study 1, we administered the Nicotine Dependence Syndrome Scale (NDSS) to 317 smokers in a smoking cessation study. Factor analysis of the NDSS revealed five factors: Drive (craving and withdrawal, and subjective compulsion to smoke), priority (preference for smoking over other reinforcers), tolerance (reduced sensitivity to the effects of smoking), continuity (regularity of smoking rate), and stereotypy (invariance of smoking). A single overall score based on the first principal component, NDSS-T, was retained as a single core measure of dependence. The NDSS showed promising psychometric properties: NDSS-T and factor scores showed strong associations with dependence-relevant measures, even when we controlled for scores on the Fagerström Tolerance Questionnaire (FTQ); and the NDSS predicted urges when smoking, withdrawal in acute abstinence, and outcome in cessation. The five factor scores showed differential patterns of correlations with external validators, supporting the multidimensionality of the measure. In study 2, we revised the NDSS to expand some subscales and administered it to 802 smokers in a cessation study. The same five factors were extracted, the internal reliability of some subscales was improved, and the factor scores again showed associations with dependence-relevant validators, which were largely maintained when we controlled for FTQ scores. In study 3, with 91 smokers in a cessation trial, we established that the test-retest reliability of the subscales was adequate. Thus, the NDSS presents a valid multidimensional assessment of nicotine dependence that may expand on current measures.

Immediate antecedents of cigarette smoking: an analysis from ecological momentary assessment.

: The authors assessed the association between smoking and situational cues, including affect, in real-world contexts. Using ecological momentary assessment, 304 smokers monitored ad-lib smoking for 1 week, recording each cigarette on palm-top computers. Generalized estimating equations contrasted 10,084 smoking and 11,155 nonsmoking situations. After controlling for smoking restrictions, smoking was strongly related to smoking urges and modestly related to consumption of coffee and food, the presence of other smokers, and several activities. Smoking was unrelated to negative or positive affect or to arousal, although it was associated with restlessness. Thus, in daily life, affect appears to exert little influence over ad-lib smoking in heavy smoking adults.

Equivalence of Electronic and Paper-and-Pencil Administration of Patient-Reported Outcome Measures: A Meta-Analytic Review

OBJECTIVES Patient-reported outcomes (PROs; self-report assessments) are increasingly important in evaluating medical care and treatment efficacy. Electronic administration of PROs via computer is becoming widespread. This article reviews the literature addressing whether computer-administered tests are equivalent to their paper-and-pencil forms. METHODS Meta-analysis was used to synthesize 65 studies that directly assessed the equivalence of computer versus paper versions of PROs used in clinical trials. A total of 46 unique studies, evaluating 278 scales, provided sufficient detail to allow quantitative analysis. RESULTS Among 233 direct comparisons, the average mean difference between modes averaged 0.2% of the scale range (e.g., 0.02 points on a 10-point scale), and 93% were within +/-5% of the scale range. Among 207 correlation coefficients between paper and computer instruments (typically intraclass correlation coefficients), the average weighted correlation was 0.90; 94% of correlations were at least 0.75. Because the cross-mode correlation (paper vs. computer) is also a test-retest correlation, with potential variation because of retest, we compared it to the within-mode (paper vs. paper) test-retest correlation. In four comparisons that evaluated both, the average cross-mode paper-to-computer correlation was almost identical to the within-mode correlation for readministration of a paper measure (0.88 vs. 0.91). CONCLUSIONS Extensive evidence indicates that paper- and computer-administered PROs are equivalent.

Negative Affect and Smoking Lapses: A Prospective Analysis.

Relapse is a central problem in smoking treatment. Data collected at the time of relapse episodes indicate that stress and negative affect (NA) promote relapse, but retrospective data are potentially biased. The authors performed a prospective analysis of stress and NA prior to initial lapses in smokers (N = 215). Day-to-day changes in stress (daily negative and positive events and Perceived Stress Scale scores) and NA (multiple momentary affect ratings) did not predict lapse risk on the following day. However, within the lapse day itself, NA was already significantly increasing hours before lapses, but only for episodes attributed to stress or bad mood. Thus, rapid increases in NA, but not slow-changing shifts in stress and NA, were associated with relapse.

Use of Smoking-Cessation Treatments in the United States

BACKGROUND Health promotion efforts encourage smokers to quit and to use effective cessation treatments. Randomized controlled trials demonstrate that medications and behavioral treatments improve cessation rates, but retrospective surveys have been inconsistent. This study assessed frequency of quit attempts, use of treatments for cessation, and abstinence rates among treatment users and non-users. METHODS Data were analyzed from the 2003 Tobacco Use Special Cessation Supplement to the Current Population Survey. Participants included 29,537 U.S. smokers aged > or =18 years who smoked daily 12 months before the survey. Outcome measures included past-year quit attempts; use of behavioral, pharmacologic, and alternative treatments; receipt of social support; and abstinence for > or =4 weeks at time of survey. RESULTS Approximately 43.5% of smokers reported a quit attempt in the preceding year: 64.2% of attempters used no cessation treatments; 8.8% used behavioral treatment; 32.2% used medication; and 14.1% used more than one treatment. Social support was reported to have been received by 24.1%. More nicotine-dependent smokers were more likely to use medications (OR=3.58; 95% CI=3.04-4.20). At the time of the survey, 19.3% of attempters were abstinent > or =4 weeks. Smokers who sought treatment were less likely to be abstinent (OR=0.75; 95% CI=0.67-0.84), and those who sought multiple treatments were even less likely to be abstinent. CONCLUSIONS Many U.S. smokers make quit attempts, but most do not use behavioral or pharmacologic treatments. More nicotine-dependent smokers were more likely to seek treatment. Smokers who sought treatment were less likely to report abstinence, probably due to biased self-selection and recall. Retrospective survey data are not well-suited to assess the effectiveness of treatment.

Are adolescent smokers dependent on nicotine? A review of the evidence

This paper reviews the empirical literature on adolescent nicotine dependence, withdrawal, and their associated features. Data documenting nicotine dependence scores, diagnoses, and individual features among adolescents are reviewed in detail and compared to observations based on adult smokers. These data are derived from a broad variety of sources, including national surveys, school-based surveys, and smoking cessation studies. Overall, results indicate that one to three out of five adolescent smokers is dependent on nicotine, with some adolescent groups clearly at higher risk for dependence (those who are incarcerated, in vocational schools, daily smokers, and/or heavy smokers). Across studies, data consistently indicate that a large majority (two-thirds or more) of adolescent smokers report experiencing withdrawal symptoms during attempts to quit or reduce their smoking. Craving or strong desire to smoke was the most commonly reported withdrawal symptom in every study reviewed. Although analyses of concurrent validity generally support the dependence and withdrawal findings among adolescents, data on the predictive validity of measures used are needed. Moreover, studies of adolescent tobacco withdrawal rely almost exclusively on retrospective self-report data. Recommendations for enhancing methodology and advancing our understanding of adolescent nicotine dependence and withdrawal are offered.