Support for incentive-sensitization theory in adolescent ad libitum smokers using ecological momentary assessment.

The incentive-sensitization theory (IST) has emerged as a potentially useful theory in explaining substance addiction. IST postulates that the prolonged use of a substance can alter neural systems that are often involved in incentive motivation and reward processes, leading to an increased "sensitization" to the substance and associated stimuli. However, this increased sensitization is thought to mediate only the individual's craving of the substance (e.g., their "wanting"), not their enjoyment of the substance (e.g., their "liking"), a process that may involve unconscious implicit changes in cognitive networks linked to specific substances. Consequently, IST may better explain the real-world dissonance reported for individuals who want to accomplish long-term substance cessation but fail to do so, a phenomenon that is common in adolescent smokers. Thus, the present study aimed to examine the principles of IST in a sample of 154 adolescent ad libitum smokers (Mage = 16.57, SDage = 1.12, 61.14% male) utilizing ecological momentary assessment. Data were analyzed utilizing a multilevel structural equation model examining changes in positive affect (PA), negative affect (NA), and stress from Time 1 (T1) and Time 2 (T2) as a function of smoking and tested the influence of implicit cognition (specifically, implicit attitudes about smoking [Implicit Association Test (IAT)]) on these associations. Consistent with the principles of IST, results found a modest significant negative association between smoking status at T1 and PA at T2 (B = -0.11, p = .047). This association was further moderated by IAT (B = -0.19, p = .029) and was particularly potentiated at high levels of IAT (B = -0.44, p < .001), compared to low (B = -0.05, p = .663) or mean levels of IAT (B = -0.25, p = .004). Findings from this study provide additional support to the principles underlying IST and indicate that, in adolescents, smoking may result in thwarted PA indicative of a transition from "liking" toward "wanting," and this is especially pronounced among those with stronger implicit smoking cognitions. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Affective and Situational Precipitants of Smoking Lapses Among Adolescents.

INTRODUCTION: Most adolescent smokers report a desire to quit, and many have made several unsuccessful quit attempts; however, when adolescents attempt to quit, they often resume smoking quickly. This ecological study aimed to (1) characterize affective and situational precipitants of smoking lapses among adolescents and (2) explore the moderating influence of nicotine dependence severity on lapse precipitants. METHODS: Adolescent daily smokers (n = 166; ages 14-18 years) completed electronic diaries of cigarettes smoked, craving and affective states, and situational variables on handheld computers in their natural environment for 2 weeks following an unassisted quit attempt. On average, adolescents were moderately nicotine dependent (Modified Fagerström Tolerance Questionnaire [mFTQ] score = 4.9; SD = 1.6). RESULTS: Craving was a significant episodic cue for lapse and stable influence on lapse, relating to 44% and 15% increased odds of lapse, respectively. High-arousal affective states-regardless of valence-were associated with 12%-13% increased odds of lapse. Low-arousal positive affective states were associated with 17% decreased odds of lapse. A 1-unit difference in a teen's mFTQ score related to 27% increased odds of lapse, but dependence severity did not moderate proximal lapse influences. CONCLUSIONS: This report provides some of the first ecological data characterizing adolescent smoking lapses following a quit attempt. As in prior work with teens, lapses were nearly universal and quickly followed the quit attempt. Specific situational and affective contexts of smoking lapses for adolescents were implicated, indicating the need for cessation interventions to address craving and high-arousal affective states as precipitators of lapse in this high-risk group. IMPLICATIONS: This report provides some of the first ecological data characterizing smoking lapses among teens attempting to quit smoking on their own. Like adults, adolescents face many barriers when making quit attempts. The present work provides ecological data to suggest that the experience of heightened arousal in teens' daily lives interferes with their efforts to quit smoking. Thus, this work highlights the importance of affective dysregulation, or amplitude of emotional feelings, for teen smoking lapses. Moment-to-moment fluctuation in craving was also implicated as a dynamic precipitator of smoking lapse in this high-risk group.

Affect, craving, and cognition: An EMA study of ad libitum adolescent smoking.

Reducing smoking among adolescents is a public health priority. Affect, craving, and cognitive processes have been identified as predictors of smoking in adolescents. The current study examined associations between implicit attitude for smoking (assessed via the positive-negative valence implicit association test) and affect, craving, and smoking assessed using ecological momentary assessment (EMA). Adolescent smokers (n = 154; Mage = 16.57, SD = 1.12) completed a laboratory assessment of implicit smoking attitudes and carried a palm-top computer for several days while smoking ad libitum. During EMA, they recorded affect, craving, and smoking behavior. Data were analyzed using a multilevel path analysis. At the between-subjects level, more positive implicit smoking attitude was indirectly associated with smoking rate via craving. This association was moderated by positive affect, such that it was stronger for those with greater traitlike positive affect. At the event (within-subject) level, implicit attitude potentiated associations between stress and craving and between positive affect and craving. Individuals with a more positive implicit attitude exhibited more robust indirect associations between momentary stress-positive affect and smoking. In sum, a more positive implicit attitude to smoking was associated with overall levels of craving and smoking and might have potentiated momentary affect-craving associations. Interventions that modify implicit attitude may be an approach for reducing adolescent smoking. (PsycINFO Database Record

Topiramate and motivational enhancement therapy for cannabis use among youth: a randomized placebo-controlled pilot study.

Cannabis misuse accounts for nearly all of the substance abuse treatment admissions among youth in the United States. Most youth do not experience sustained benefit from existing psychosocial treatments; however, medication development research for treating adolescent cannabis misuse is almost nonexistent. We conducted a double-blind, placebo-controlled, pilot study to test the potential efficacy of topiramate plus motivational enhancement therapy (MET) for treating cannabis use among adolescents. Sixty-six heavy cannabis users, ages 15 to 24 years, were randomized to one of two 6-week treatment conditions: topiramate plus MET or placebo plus MET. Topiramate was titrated over 4 weeks then stabilized at 200 mg/day for 2 weeks. MET was delivered biweekly for a total of three sessions. Only 48 percent of youths randomized to topiramate completed the 6-week trial (n = 19), compared with 77 percent of youths in the placebo condition (n = 20). Adverse medication side effects were the most common reason for withdrawal among participants in the topiramate group. Latent growth models showed that topiramate was superior to placebo for reducing the number of grams smoked per use day, but it did not improve abstinence rates. The same pattern of results was found when values for missing outcomes were imputed. We show that topiramate combined with MET demonstrated efficacy for reducing how much cannabis adolescents smoked when they used but did not affect abstinence rates. The magnitude of this effect was modest, however, and topiramate was poorly tolerated by youths, which calls into question the clinical importance of these findings.

Self-Paced Exercise, Affective Response, and Exercise Adherence: A Preliminary Investigation Using Ecological Momentary Assessment.

Affective response to exercise may mediate the effects of self-paced exercise on exercise adherence. Fiftynine low-active (exercise <60 min/week), overweight (body mass index: 25.0-39.9) adults (ages 18-65) were randomly assigned to self-paced (but not to exceed 76% maximum heart rate) or prescribed moderate intensity exercise (64-76% maximum heart rate) in the context of otherwise identical 6-month print-based exercise promotion programs. Frequency and duration of exercise sessions and affective responses (good/bad) to exercise were assessed via ecological momentary assessment throughout the 6-month program. A regression-based mediation model was used to estimate (a) effects of experimental condition on affective response to exercise (path a = 0.20, SE = 0.28, f2 = 0.02); (b) effects of affective response on duration/latency of the next exercise session (path b = 0.47, SE = 0.25, f2 = 0.04); and (c) indirect effects of experimental condition on exercise outcomes via affective response (path ab = 0.11, SE = 0.06, f2 = 0.10). Results provide modest preliminary support for a mediational pathway linking self-paced exercise, affective response, and exercise adherence.

With others or alone? Adolescent individual differences in the context of smoking lapses.

OBJECTIVE: Although a great deal of adolescent smoking research has investigated predictors of initiation, much less has focused on predictors of lapsing during a quit attempt. In particular, the role of social context may deserve greater attention in models of adolescent smoking cessation. Therefore, the present investigation aimed to use ecological momentary assessment (EMA) to examine individual differences in social lapsing--the extent to which lapses occur around others versus when alone. METHODS: Analyses focused on 179 adolescent smokers (aged 14-18 years) engaged in an unassisted quit attempt. There were 2 general EMA assessment intervals: prequit (1 week) and postquit (2 weeks). Participants reported every time that they smoked a cigarette and at random, nonsmoking times; in each assessment, participants responded to questions about their current environment, behaviors, and psychological state. A 3-month follow-up assessed longer-term smoking-related outcomes. RESULTS: Consistent with other adolescent research, the overall rate of lapsing was very high (93%). Social lapsing rates were likewise high (among those who lapsed, 73% reported their first lapse was social), but they also varied continuously across individuals. We computed a social lapsing coefficient for each youth and found that it related to smoking factors at baseline (e.g., lower smoking intensity and dependence) and follow-up (e.g., lower cotinine levels). CONCLUSIONS: These results suggest that higher rates of social lapsing are associated with being a lighter, less dependent smoker and having better eventual cessation prospects. Findings provide evidence that accounting for variability in social lapsing may improve theory and treatment.

Recommending self-paced exercise among overweight and obese adults: a randomized pilot study.

BACKGROUND: National guidelines call for exercise of at least moderate intensity; however, recommending self-paced exercise may lead to better adherence, particularly among overweight and obese adults. PURPOSE: The purpose of this study was to test proof-of-concept for recommending self-paced exercise among overweight adults. METHODS: Fifty-nine healthy, low-active (exercise <60 min/week), overweight (body mass index 25.0-39.9) adults (18-65) received a 6-month print-based exercise promotion program with the goal of walking 30-60 min/day. Participants were surreptitiously randomly assigned to receive a recommendation for either self-paced (n = 30) or moderate (64-76 % maximum heart rate; n = 29) intensity exercise. All participants used electronic diaries and heart rate monitors to track exercise frequency, duration, and intensity. RESULTS: The self-paced condition reported more minutes/week of walking (f (2) = 0.17, p = 0.045) and a trend toward greater exercise-related energy expenditure/week (f (2) = 0.12, p = 0.243), corresponding to approximately 26 additional minutes/week and 83 additional kilocalories/week over 6 months. CONCLUSIONS: Explicit recommendation for self-paced exercise may improve adherence to exercise programs among overweight and obese adults.

Predictive Value of Baseline Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) Assessments for Identifying Risk of Prospective Reports of Suicidal Behavior During Research Participation.

OBJECTIVE: Examine the ability of baseline electronic Columbia-Suicide Severity Rating Scale lifetime suicidal ideation and behavior categories to predict prospective reports of suicidal behavior in psychiatric and non-psychiatric research participants. DESIGN: Meta-analysis of 74,406 eC-SSRS assessments completed between September 2009 and December 2012. SETTING: Thirty-three clinical research studies that used the electronic Columbia-Suicide Severity Rating Scale to assess suicidal ideation and behavior at baseline and prospectively during follow-up visits. PARTICIPANTS: Records from 6,760 patients with psychiatric disorders (opioid dependence, generalized anxiety, major depressive, and posttraumatic stress disorders) and 2,077 nonpsychiatric disorder patients (chronic obstructive pulmonary disease, epilepsy, fibromyalgia, human immunodeficiency virus, insomnia, multiple sclerosis, osteoarthritis, pain/back pain, Parkinson's disease, restless leg syndrome) were analyzed. MEASUREMENTS: Electronic Columbia-Suicide Severity Rating Scale assessment of lifetime suicidal ideation (5 severity levels) and suicidal behavior (4 types) at baseline and prospectively reported suicidal behavior during study participation. RESULTS: Increasingly more severe lifetime suicidal ideation at baseline was associated with a progressively greater likelihood of prospectively reported suicidal behavior during study participation. Intent to act on suicidal ideation was most predictive of reports of suicidal behavior. Reports of lifetime suicidal behaviors at baseline also predicted subsequent suicidal behavior, and multiple lifetime behaviors monotonically increased prospective risk of suicidal behavior. Baseline suicidal ideation and behavior predicted future suicidal behavior in both psychiatric and non-psychiatric trials. CONCLUSIONS: Lifetime reports of suicidal ideation and/or behavior at baseline significantly increased risk of prospectively reporting suicidal behavior during research trial participation in both psychiatric and nonpsychiatric patients. Lifetime prevalence of suicidal ideation and behavior is higher among psychiatric patients, but also presents a safety concern among nonpsychiatric patients when reported.

Individual versus significant-other-enhanced brief motivational intervention for alcohol in emergency care.

OBJECTIVE: Effects of brief motivational interventions (BMIs) for heavy drinkers identified by alcohol-related emergency department (ED) visits are mixed. The successes of including significant others (SOs) in behavioral treatment suggest that involving SOs in ED-delivered BMI might prove beneficial. This study investigated the relative efficacy of an SO-enhanced motivational intervention (SOMI) compared with an individual motivational intervention (IMI) to address heavy drinking in emergency care settings. METHOD: ED (n = 317) or trauma unit (n = 89) patients were randomly assigned to receive either an IMI or an SOMI and were reassessed at 6 and 12 months for alcohol consumption, alcohol-related consequences, and perceived alcohol-specific SO support. RESULTS: Generalized estimating equation analyses showed consistent reductions over time for both alcohol consumption and consequences. At 1-year follow-up, the average reduction in total drinks consumed per week was greater for patients in the SOMI condition than the IMI condition. In SOMI, 9.4% more patients moved to within the national guidelines for weekly drinking than did IMI patients. Frequency of heavy drinking and negative alcohol consequences showed no differential effects of intervention. CONCLUSIONS: Emergence of a modest treatment effect at 12 months suggests that SO involvement in the SOMI condition may have led to more sustained positive influence on patient drinking than in the IMI condition. Implications and limitations regarding SO involvement in brief treatment are discussed.

Relationship between momentary affect states and self-efficacy in adolescent smokers.

OBJECTIVE: Relapse to smoking after making a quit attempt is both common and rapid in adolescent smokers. Momentary self-efficacy (SE)-that is, momentary shifts in one's confidence in the ability to abstain from smoking-predicts the occurrence and timing of relapse among adolescent smokers. Therefore, it is important to identify factors that are associated with changes in momentary SE early in a quit attempt. This study examined the relationship between affect states (including positive, negative, and nicotine withdrawal states) and momentary SE at various stages of a quit attempt. METHOD: Adolescent daily smokers interested in making a quit attempt (n = 202) completed ecological momentary assessments (EMA) each day for 1 week leading up to and 2 weeks after a quit attempt. In each assessment, they reported current SE and affect state. RESULTS: RESULTS of linear mixed models indicated that most of the examined affect states were related to momentary SE. Contrary to expectation, they were related to momentary SE both immediately before and after the quit attempt. Moderation effects were observed for select affect states, where higher baseline SE was related to lower momentary SE in the presence of increasing negative high activation, boredom, and difficulty concentrating. CONCLUSIONS: Our findings suggest that both positive and negative affect states are related to SE, and that thereby positive affect enhancement may be a promising, underutilized treatment target.

Characterizing subjective responses to alcohol among adolescent problem drinkers.

Theoretical models of alcoholism emphasize the acute reinforcing properties of alcohol as chief determinants of drinking, and animal research suggests adolescents are uniquely sensitive to these effects. Human studies of these phenomena, however, are virtually nonexistent. We used ecological momentary assessment methods to capture adolescents' subjective responses to alcohol in real time in their natural environments. Adolescent participants were 22 problem drinkers, ages 15 to 19 years (M = 18.3, SD = 0.09; 55% female; 55% alcohol dependent). Participants consumed alcohol on 38% of days during a 1-week monitoring period, with an average of 5 drinks per occasion. Momentary data revealed that adolescents experience decreased stimulation and increased sedation and "high" across the ascending limb of the blood alcohol curve. Notably, greater craving predicted higher volumes of subsequent alcohol consumption during the episode, whereas greater "high" attenuated use. To test for developmental differences in these effects, we pooled these data with data from a similarly ascertained sample of 36 adult heavy drinkers, ages 24 to 64 years (M = 38.1, SD = 11.8; 50% female; 61% alcohol dependent). Adolescents were more sensitive to the stimulant effects of alcohol than adults. This study provides novel data on how adolescent problem drinkers experience alcohol in their natural contexts and illustrates how these effects, which appear to differ from adult problem drinkers, confer liability for future drinking.

Overcoming limitations in previous research on exercise as a smoking cessation treatment: rationale and design of the "Quit for Health" trial.

Aerobic exercise has been proposed as a stand-alone or adjunct smoking cessation treatment, but findings have been mixed. Laboratory studies have shown that individual exercise sessions lead to decreases in withdrawal symptoms and cigarette cravings, but findings are limited by lack of follow-up and artificial settings. On the other hand, smoking cessation treatment RCTs have generally failed to show positive effects of exercise on smoking cessation, but have been plagued by poor and/or unverified compliance with exercise programs. This paper describes the rationale and design for Quit for Health (QFH)--an RCT designed to determine the efficacy of aerobic exercise as an adjunct smoking cessation treatment among women. To overcome limitations of previous research, compliance with the exercise (and wellness contact control) program is incentivized and directly observed, and ecological momentary assessment is used to examine change over time in withdrawal symptoms and cigarette cravings in participants' natural environments.

Effects of naltrexone on adolescent alcohol cue reactivity and sensitivity: an initial randomized trial.

Adolescent alcohol use is associated with myriad adverse consequences and contributes to the leading causes of mortality among youth. Despite the magnitude of this public health problem, evidenced-based treatment initiatives for alcohol use disorders in youth remain inadequate. Identifying promising pharmacological approaches may improve treatment options. Naltrexone is an opiate receptor antagonist that is efficacious for reducing drinking in adults by attenuating craving and the rewarding effects of alcohol. Implications of these findings for adolescents are unclear; however, given that randomized trials of naltrexone with youth are non-existent. We conducted a randomized, double-blinded, placebo-controlled cross-over study, comparing naltrexone (50 mg/daily) and placebo in 22 adolescent problem drinkers aged 15-19 years (M = 18.36, standard deviation = 0.95; 12 women). The primary outcome measures were alcohol use, subjective responses to alcohol consumption, and alcohol-cue-elicited craving assessed in the natural environment using ecological momentary assessment methods, and craving and physiological reactivity assessed using standard alcohol cue reactivity procedures. Results showed that naltrexone reduced the likelihood of drinking and heavy drinking (P's ≤ 0.03), blunted craving in the laboratory and in the natural environment (P's ≤ 0.04), and altered subjective responses to alcohol consumption (P's ≤ 0.01). Naltrexone was generally well tolerated by participants. This study provides the first experimentally controlled evidence that naltrexone reduces drinking and craving, and alters subjective responses to alcohol in a sample of adolescent problem drinkers, and suggests larger clinical trials with long-term follow-ups are warranted.

The Psoriasis Symptom Diary: development and content validity of a novel patient-reported outcome instrument.

BACKGROUND: Chronic plaque psoriasis has a profound impact on a patient's daily life. To understand the effects of psoriasis treatments, it is essential to assess the patient's experience of symptoms and how they impact their daily life. The goal of this study was to develop and establish the content validity of a new patient reported outcome (PRO) psoriasis measure. METHODS: The Psoriasis Symptom Diary was developed by (i) identifying key plaque psoriasis-related symptoms and impacts through qualitative patient interviews (n = 29); (ii) developing an initial set of items that captured the key patient experiences; and (iii) conducting cognitive interviews to test patient understanding of items selected for inclusion in the new psoriasis symptom measure (n = 16). RESULTS: Patients noted a variety of symptoms, with plaque-related pain (including related concepts of burning and stinging), changes in skin appearance, and itching reported by all patients. Patients also expressed notable embarrassment and avoidance of social situations, due to the appearance of plaques, and limited mobility. The Psoriasis Symptom Diary assesses the severity and impact of symptoms using a 24-hour recall period to reduce recall bias and error. CONCLUSIONS: The Psoriasis Symptom Diary was developed to assess important symptoms and disease-related impacts in a manner consistent with guidelines for establishing the content validity of new PRO instruments. Following quantitative psychometric testing, the Psoriasis Symptom Diary may support efficacy endpoints in clinical trials.

Item-level psychometric properties for a new patient-reported psoriasis symptom diary.

OBJECTIVES: This research evaluated the psychometric properties of a new Psoriasis Symptom Diary, identified diary responder definitions for use in determining whether a patient has experienced clinically meaningful change, and refined diary item content for use in future clinical trials. METHODS: The Psoriasis Symptom Diary was administered in a phase 2 clinical trial of AIN457 to US adult outpatients (N = 172) with physician-diagnosed moderate to severe chronic plaque-type psoriasis. Participant compliance with daily diary administration and item score variability, reliability, construct and discriminant validity, sensitivity to change, and interpretation were all evaluated. RESULTS: Participants completed 94% of scheduled diary assessments across 12 study weeks. Diary items were generally normally distributed, and no floor or ceiling effects were observed. Item reliability (reproducibility) was acceptable (intraclass correlation coefficients > 0.80), with an exception for one item (skin color). At week 12, items significantly related to criterion measures as predicted (Psoriasis Area and Severity Index r = 0.27-0.57; Investigator's Global Assessment r = 0.25-0.59), with the exception of items that measured skin color and difficulty using hands. Most items generated change scores that were synchronous to changes as measured by the Psoriasis Area and Severity Index, Investigator's Global Assessment, Dermatology Life Quality Index (r > 0.37), as well as the Patient Global Impression of Change. Responders experienced a 2- to 3-point and 3- to 5-point change in item scores for minimal and large improvements, respectively. Four items that did not perform well were dropped from the diary. CONCLUSIONS: The 16-item Psoriasis Symptom Diary demonstrated favorable psychometric properties and is a brief, useful tool for measuring patient-based symptoms and the impact of chronic plaque psoriasis.

High Hostility Among Smokers Predicts Slower Recognition of Positive Facial Emotion.

High levels of trait hostility are associated with wide-ranging interpersonal deficits and heightened physiological response to social stressors. These deficits may be attributable in part to individual differences in the perception of social cues. The present study evaluated the ability to recognize facial emotion among 48 high hostile (HH) and 48 low hostile (LH) smokers and whether experimentally-manipulated acute nicotine deprivation moderated relations between hostility and facial emotion recognition. A computer program presented series of pictures of faces that morphed from a neutral emotion into increasing intensities of happiness, sadness, fear, or anger, and participants were asked to identify the emotion displayed as quickly as possible. Results indicated that HH smokers, relative to LH smokers, required a significantly greater intensity of emotion expression to recognize happiness. No differences were found for other emotions across HH and LH individuals, nor did nicotine deprivation moderate relations between hostility and emotion recognition. This is the first study to show that HH individuals are slower to recognize happy facial expressions and that this occurs regardless of recent tobacco abstinence. Difficulty recognizing happiness in others may impact the degree to which HH individuals are able to identify social approach signals and to receive social reinforcement.

Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument.

The importance of content validity in developing patient reported outcomes (PRO) instruments is stressed by both the US Food and Drug Administration and the European Medicines Agency. Content validity is the extent to which an instrument measures the important aspects of concepts that developers or users purport it to assess. A PRO instrument measures the concepts most significant and relevant to a patient's condition and its treatment. For PRO instruments, items and domains as reflected in the scores of an instrument should be important to the target population and comprehensive with respect to patient concerns. Documentation of target population input in item generation, as well as evaluation of patient understanding through cognitive interviewing, can provide the evidence for content validity. Developing content for, and assessing respondent understanding of, newly developed PRO instruments for medical product evaluation will be discussed in this two-part ISPOR PRO Good Research Practices Task Force Report. Topics include the methods for generating items, documenting item development, coding of qualitative data from item generation, cognitive interviewing, and tracking item development through the various stages of research and preparing this tracking for submission to regulatory agencies. Part 1 covers elicitation of key concepts using qualitative focus groups and/or interviews to inform content and structure of a new PRO instrument. Part 2 covers the instrument development process, the assessment of patient understanding of the draft instrument using cognitive interviews and steps for instrument revision. The two parts are meant to be read together. They are intended to offer suggestions for good practices in planning, executing, and documenting qualitative studies that are used to support the content validity of PRO instruments to be used in medical product evaluation.

Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2--assessing respondent understanding.

The importance of content validity in developing patient reported outcomes (PRO) instruments is stressed by both the US Food and Drug Administration and the European Medicines Agency. Content validity is the extent to which an instrument measures the important aspects of concepts developers or users purport it to assess. A PRO instrument measures the concepts most relevant and important to a patient's condition and its treatment. For PRO instruments, items and domains as reflected in the scores of an instrument should be important to the target population and comprehensive with respect to patient concerns. Documentation of target population input in item generation, as well as evaluation of patient understanding through cognitive interviewing, can provide the evidence for content validity. Part 1 of this task force report covers elicitation of key concepts using qualitative focus groups and/or interviews to inform content and structure of a new PRO instrument. Building on qualitative interviews and focus groups used to elicit concepts, cognitive interviews help developers craft items that can be understood by respondents in the target population and can ultimately confirm that the final instrument is appropriate, comprehensive, and understandable in the target population. Part 2 details: 1) the methods for conducting cognitive interviews that address patient understanding of items, instructions, and response options; and 2) the methods for tracking item development through the various stages of research and preparing this tracking for submission to regulatory agencies. The task force report's two parts are meant to be read together. They are intended to offer suggestions for good practice in planning, executing, and documenting qualitative studies that are used to support the content validity of PRO instruments to be used in medical product evaluation.

Adolescent first lapse following smoking cessation: situation characteristics, precipitants and proximal influences.

Despite increased attention to adolescent smoking cessation, little is known about adolescent relapse following a quit attempt. To address this issue, the present study was designed to provide initial information regarding the characteristics of adolescent lapses to smoking following abstinence. Included in the present study were 204 adolescent participants in four independent smoking cessation trials. For the full sample, participants averaged 15.99 (1.27) years of age; 56% were female and 78% were white. Lapse characteristics and precipitants were assessed using the Adolescent Smoking Relapse Review. Three domains of the lapse experience were assessed: lapse situation characteristics, precipitants of use in the situation, and proximal influences (i.e., potential precipitants occurring on the same day, prior to the lapse situation). Participant reports indicated that the modal lapse situation occurred in the evening while socializing with friends at home. Urges or cravings and social pressure were commonly endorsed as occurring in lapse situations. The most frequently reported proximal influence was desire for a cigarette, followed by abstinence-violation cognitions (okay to smoke occasionally, wanted to see what it would be like) and negative emotions. The findings indicate that a broad range of factors appear to influence adolescent smoking lapse and commend the value of incorporating content relevant to managing social and affective cues, strategies for inhibiting the prepotent response to ask for a cigarette, addressing cognitions regarding the difficulty of not smoking (i.e., cessation expectancies) and combating perceptions of the ability to smoke occasionally.

Using daily drinking data to characterize the effects of a brief alcohol intervention in an emergency room.

Clinical trials often aggregate daily alcohol consumption data across long-term follow-up intervals (e.g., 6 or 12 months). Although important in understanding general treatment outcomes, these analyses tell us little about when treatment effects emerge or decline. We previously demonstrated that motivational interviewing (MI) reduced heavy drinking (vs. personalized feedback only; FO) among young adult drinkers (N=198; ages 18-24) recruited in a hospital emergency room (ER) using aggregated drinking data from a 6-month follow up. In the current study, we used daily alcohol consumption data from a calendar-assisted interview (Timeline Followback) to examine the timing and course of these treatment effects. Participants in both conditions received brief telephone booster sessions at 1 and 3 months. There were no treatment effects in the time between the initial intervention session and the 3-month booster session. Significant effects emerged after the 3-month booster and were driven by an increase in heavy drinking within the FO group. This suggests that the effects of brief interventions may not emerge immediately following an initial session. Aggregated data would be unable to detect this time trend. This research underscores the potential value added by examining the day-to-day timing of effects following treatments for alcohol use.