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1.  Designing Messaging to Engage Patients in an Online Suicide Prevention Intervention: Survey Results From Patients With Current Suicidal Ideation 
Background
Computerized, Internet-delivered interventions can be efficacious; however, uptake and maintaining sustained client engagement are still big challenges. We see the development of effective engagement strategies as the next frontier in online health interventions, an area where much creative research has begun. We also argue that for engagement strategies to accomplish their purpose with novel targeted populations, they need to be tailored to such populations (ie, content is designed with the target population in mind). User-centered design frameworks provide a theoretical foundation for increasing user engagement and uptake by including users in development. However, deciding how to implement this approach to enage users in mental health intervention development is challenging.
Objective
The aim of this study was to get user input and feedback on acceptability of messaging content intended to engage suicidal individuals.
Methods
In March 2013, clinic intake staff distributed flyers announcing the study, “Your Feedback Counts” to potential participants (individuals waiting to be seen for a mental health appointment) together with the Patient Health Questionnaire. The flyer explained that a score of two or three (“more than half the days” or “nearly every day” respectively) on the suicide ideation question made them eligible to provide feedback on components of a suicide prevention intervention under development. The patient could access an anonymous online survey by following a link. After providing consent online, participants completed the anonymous survey.
Results
Thirty-four individuals provided data on past demographic information. Participants reported that they would be most drawn to an intervention where they knew that they were cared about, that was personalized, that others like them had found it helpful, and that included examples with real people. Participants preferred email invitations with subject lines expressing concern and availability of extra resources. Participants also provided feedback about a media prototype including a brand design and advertisement video for introducing the intervention.
Conclusions
This paper provides one model (including development of an engagement survey, audience for an engagement survey, methods for presenting results of an engagement survey) for including target users in the development of uptake strategies for online mental health interventions.
doi:10.2196/jmir.3173
PMCID: PMC3936268  PMID: 24509475
human centered design; user centered design; health 2.0; suicide
2.  Predictors of Persistence After a Positive Depression Screen Among Adolescents 
Pediatrics  2012;130(6):e1541-e1548.
OBJECTIVE:
To examine predictors of depression persistence after a positive screening test to inform management protocols for screened youth.
METHODS:
We conducted a cohort study of 444 youth (aged 13–17 years) from a large health care delivery system. Youth with depressive symptoms, based on a 2-item depression screen, were oversampled for the baseline interview. Baseline assessments included the Patient Health Questionnaire 9-item (PHQ-9) depression screen as well as clinical factors that were hypothesized to influence depression persistence (family history of depression, functional impairment, perceived social support, anxiety symptoms, externalizing symptoms, and medical comorbidity). Logistic regression analysis was used to examine factors associated with the persistence of depression at 6 months postbaseline.
RESULTS:
Of 113 youth with a positive baseline screen (PHQ-9 ≥11), 47% and 35% continued to be positive at 6-week and 6-month follow-up, respectively. After controlling for treatment status, only 2 factors were significantly associated with depression persistence at 6 months: baseline depressive symptom score and continuing to have a positive screen at 6 weeks. For each 1-point increase on the PHQ-9 score at baseline, youth had a 16% increased odds of continuing to be depressed at 6 months (odds ratio: 1.16, 95% confidence interval: 1.01–1.34). Youth who continued to screen positive 6 weeks later had almost 3 times the odds of being depressed at 6 months (odds ratio: 2.89, 95% confidence interval: 1.09–7.61).
CONCLUSIONS:
Depressive symptom severity at presentation and continued symptoms at 6 weeks postscreening are the strongest predictors of depression persistence. Patients with high depressive symptom scores and continued symptoms at 6 weeks should receive active treatment.
doi:10.1542/peds.2012-0450
PMCID: PMC3507250  PMID: 23166342
adolescent depression; screening; primary care
3.  Depressive symptoms in adolescence: the association with multiple health risk behaviors 
General hospital psychiatry  2010;32(3):233-239.
Objective
Although multiple studies of adolescents have examined the association of depression with individual health risk behaviors such as obesity or smoking, this is one of the few studies that examined the association between depression and multiple risk behaviors.
Methods
A brief mail questionnaire, which screened for age, gender, weight, height, sedentary behaviors, physical activity, perception of general health, functional impairment and depressive symptoms, was completed by a sample of 2291 youth (60.7% response rate) aged 13–17 enrolled in a health care plan. A subset of youth who screened positive on the two-item depression screen and a random sample of those screening negative were approached to participate in a telephone interview with more in-depth information obtained on smoking and at-risk behaviors associated with drug and alcohol use.
Results
Youth screening positive for high levels of depressive symptoms compared to those with few or no depressive symptoms were significantly more likely to meet criteria for obesity, had a poorer perception of health, spent more time on the computer, got along less well with parents and friends, had more problems completing school work and were more likely to have experimented with smoking and a wide array of behaviors associated with drug and alcohol use.
Conclusions
Because many adverse health behaviors that develop in adolescence continue into adulthood, the association of depressive symptoms with multiple risk behaviors and poor functioning suggest that early interventions are needed at an individual, school, community and primary care level.
doi:10.1016/j.genhosppsych.2010.01.008
PMCID: PMC3671856  PMID: 20430225
Depression; Adolescence; Behavior
4.  Varenicline for Smoking Cessation: Nausea Severity and Variation in Nicotinic Receptor Genes 
The Pharmacogenomics Journal  2011;12(4):349-358.
This study evaluated association between common and rare sequence variants in 10 nicotinic acetylcholine receptor subunit genes and the severity of nausea 21 days after initiating the standard, FDA-approved varenicline regimen for smoking cessation. Included in the analysis were 397 participants from a randomized clinical effectiveness trial with complete clinical and DNA resequencing data (mean age = 49.2 years; 68.0% female). Evidence for significant association between common sequence variants in CHRNB2 and nausea severity was obtained after adjusting for age, gender, and correlated tests (all PACT<.05). Individuals with the minor allele of CHRNB2 variants experienced less nausea than did those without the minor allele, consistent with previously reported findings for CHRNB2 and the occurrence of nausea and dizziness as a consequence of first smoking attempt in adolescents, and with the known neurophysiology of nausea. As nausea is the most common reason for discontinuance of varenicline, further pharmacogenetic investigations are warranted.
doi:10.1038/tpj.2011.19
PMCID: PMC3405554  PMID: 21606948
varenicline; nausea; smoking cessation; adherence
5.  Adolescents with Suicidal Ideation: Health Care Use and Functioning 
Academic pediatrics  2011;11(5):422-426.
Objective
To improve our understanding of the clinical needs among youth with suicidal ideation (SI), we examined health care utilization patterns, functional impairment and co-morbidity among youth who endorsed SI, compared to a control group of youth without SI.
Method
This study included 99 youth with SI in the past year and 99 matched controls. Participants were 13–17 year old youth who were enrolled in a large integrated care delivery system who had seen a provider at least one time in the past year. The two groups were compared with regard to health care utilization, functional impairment, and co-morbid mental health symptoms, while adjusting for depression severity, lifetime diagnosis of depression or anxiety, and medical co-morbidity.
Results
Youth with SI had a significantly higher mean functional impairment compared to youth without SI, both at baseline (84% versus 60% “definitely impaired”) and six-month follow up (57% versus 39% “definitely impaired”). Less than 15% in either group attended a mental health specialty visit in the 12 months before or after baseline, and under 10% received antidepressant or anxiolytic medication. Family-report data suggested that a higher proportion of youth with SI received mental health care from sources outside their healthcare system compared to youth without SI.
Conclusions
The presence of SI is associated with more severe functional impairment, comorbidity, and depression severity. Yet, only a minority of adolescents with SI receive mental health services and clinical detection is low. This study suggests that better screening, recognition, and treatment of SI is needed to address the clinical impairment of youth with SI.
What’s New
While most youth with SI were receiving medical ambulatory care visits, a very low percentage received mental health care, despite the fact that the presence of SI was associated with more severe functional impairment and co-morbidity.
doi:10.1016/j.acap.2011.01.004
PMCID: PMC3134564  PMID: 21396897
adolescent; suicide; utilization; mental health
6.  Utilization of Services in a Randomized Trial Testing Phone- and Web-Based Interventions for Smoking Cessation 
Nicotine & Tobacco Research  2011;13(5):319-327.
Introduction:
Phone counseling has become standard for behavioral smoking cessation treatment. Newer options include Web and integrated phone–Web treatment. No prior research, to our knowledge, has systematically compared the effectiveness of these three treatment modalities in a randomized trial. Understanding how utilization varies by mode, the impact of utilization on outcomes, and predictors of utilization across each mode could lead to improved treatments.
Methods:
One thousand two hundred and two participants were randomized to phone, Web, or combined phone–Web cessation treatment. Services varied by modality and were tracked using automated systems. All participants received 12 weeks of varenicline, printed guides, an orientation call, and access to a phone supportline. Self-report data were collected at baseline and 6-month follow-up.
Results:
Overall, participants utilized phone services more often than the Web-based services. Among treatment groups with Web access, a significant proportion logged in only once (37% phone–Web, 41% Web), and those in the phone–Web group logged in less often than those in the Web group (mean = 2.4 vs. 3.7, p = .0001). Use of the phone also was correlated with increased use of the Web. In multivariate analyses, greater use of the phone- or Web-based services was associated with higher cessation rates. Finally, older age and the belief that certain treatments could improve success were consistent predictors of greater utilization across groups. Other predictors varied by treatment group.
Conclusions:
Opportunities for enhancing treatment utilization exist, particularly for Web-based programs. Increasing utilization more broadly could result in better overall treatment effectiveness for all intervention modalities.
doi:10.1093/ntr/ntq257
PMCID: PMC3082503  PMID: 21330267
7.  Adherence to Varenicline in the COMPASS Smoking Cessation Intervention Trial 
Nicotine & Tobacco Research  2011;13(5):361-368.
Introduction:
Patient adherence to smoking cessation medications can impact their effectiveness. It is important to understand the extent to which prescribed medications are actually taken by smokers, how this influences smoking cessation outcomes, and what factors may influence adherence.
Methods:
Smokers recruited from a large health plan were randomized to receive different modes of cessation counseling in combination with varenicline (Swan, G. E., McClure, J. B., Jack, L. M., Zbikowski, S. M., Javitz, H. S., Catz, S. L., et al. 2010.Behavioral counseling and varenicline treatment for smoking cessation. American Journal of Preventive Medicine, 38, 482–490). One thousand one hundred and sixty-one participants were mailed a 28-day varenicline supply when they set a quit date and were able to request up to two refills from the health plan pharmacy at no cost. Pharmacy fill records were obtained and telephone surveys completed at baseline, 21 days, 12 weeks, and 6 months post target quit date.
Results:
Good adherence to varenicline (≥80% of days taken) was associated with a twofold increase in 6-month quit rates compared with poor adherence (52% vs. 25%). Smokers were more likely than nonsmokers to stop varenicline early. Purposeful nonadherence was associated with smoking at 12 weeks and was predicted in multivariate analyses by age, gender, adherence self-efficacy, and initial medication side effect severity.
Conclusions:
Innovative methods for increasing adherence to smoking cessation medications are needed, particularly early in the quit process. Simple metrics of adherence such as number of days cessation medication is taken can and should be routinely incorporated in effectiveness trials and reported to advance future attempts to understand and reduce nonadherence.
doi:10.1093/ntr/ntr003
PMCID: PMC3082504  PMID: 21350041
8.  Cost-effectiveness of varenicline and three different behavioral treatment formats for smoking cessation 
There is a lack of evidence of the relative cost-effectiveness of proactive telephone counseling (PTC) and Web-based delivery of smoking cessation services in conjunction with pharmacotherapy. We calculated the differential cost-effectiveness of three behavioral smoking cessation modalities with varenicline treatment in a randomized trial of current smokers from a large health system. Eligible participants were randomized to one of three smoking cessation interventions: Web-based counseling (n=401), PTC (n=402), or combined PTC-Web counseling (n=399). All participants received a standard 12-week course of varenicline. The primary outcome was a 7-day point prevalent nonsmoking at the 6month follow-up. The Web intervention was the least expensive followed by the PTC and PTC-Web groups. Costs per additional 6-month nonsmoker and per additional lifetime quitter were $1,278 and $2,601 for Web, $1,472 and $2,995 for PTC, and $1,617 and $3,291 for PTC-Web. Cost per life-year (LY) and quality-adjusted life-year (QALY) saved were $1,148 and $1,136 for Web, $1,320 and $1,308 for PTC, and $1,450 and $1,437 for PTC-Web. Based on the cost per LY and QALY saved, these interventions are among the most cost-effective life-saving medical treatments. Web, PTC, and combined PTC-Web treatments were all highly cost-effective, with the Web treatment being marginally more cost-effective than the PTC or combined PTC-Web treatments.
doi:10.1007/s13142-010-0009-8
PMCID: PMC3124766  PMID: 21731592
Smoking cessation; Varenicline; Cost-effectiveness; Quality-adjusted life-years saved; Behavioral intervention
9.  Evaluation of the Patient Health Questionnaire (PHQ-9) for Detecting Major Depression among Adolescents 
Pediatrics  2010;126(6):1117-1123.
Objective
The purpose of this study was to examine the performance characteristics and validity of the Patient Health Questionnaire - 9 item (PHQ-9) as a screening tool for depression among adolescents.
Methods
The PHQ-9 was completed by 442 youth (13-17 years) who were enrolled in a large healthcare delivery system and participating in a study on depression outcomes. Criterion validity and performance characteristics were assessed against an independent structured mental health interview (the Child Diagnostic Interview Schedule, DISC-IV). Construct validity was tested by examining associations between the PHQ-9 and a self-report measure of functional impairment, as well as parental reports of child psychosocial impairment and internalizing symptoms.
Results
A PHQ-9 score ≥11 had a sensitivity of 89.5% and specificity of 77.5% for detecting youth meeting DSM-IV criteria for major depression on the DISC-IV. On ROC analysis the PHQ-9 had an area under the curve of 0.88 (95% CI = 0.82 to 0.94) and the cut point of 11 was optimal for maximizing sensitivity without loss of specificity. Increasing PHQ-9 scores were significantly correlated with increasing levels of functional impairment, as well as parental report of internalizing symptoms and psychosocial problems.
Conclusion
Although the optimal cut point is higher among adolescents, the sensitivity and specificity of the PHQ-9 are similar to those of adult populations. The brief nature and ease of scoring of this instrument make this tool an excellent choice for providers and researchers seeking to implement depression screening in primary care settings.
doi:10.1542/peds.2010-0852
PMCID: PMC3217785  PMID: 21041282
depression; adolescents; screening; primary care
10.  SURVEYING ADOLESCENTS ENROLLED IN A REGIONAL HEALTHCARE DELIVERY ORGANIZATION: MAIL & PHONE FOLLOW-UP--WHAT WORKS AT WHAT COST? 
PURPOSE
To describe the differential completion rates and cost of sequential methods for a survey of adolescent regional healthcare delivery organization enrollees.
METHODS
4000 randomly selected enrollees were invited to complete a mailed health survey. Techniques used to boost response included: 1) a follow-up mailing 2) varying the appearance of the survey 3) reminder calls 4) phone calls to obtain parent and child consent and administer the survey. We evaluated the outcome and costs of these methods.
RESULTS
783 (20%) enrollees completed the 1st mailed survey, and 521 completed the 2nd, increasing the overall response rate to 33%. Completion was significantly higher for respondents who received only the plain survey than those receiving only the color (p<.001). Reminder calls boosted response by 8%. Switching to phone survey administration boosted response by 20% to 61%. The cost per completed survey was $29 for the first mailing, $26 after both mailings, $42 for mailings and reminder calls, and $48 for adding phone surveys.
CONCLUSIONS
The response to mailings and reminder calls was low and the cost high, with decreasing yield at each step, though some low cost techniques helpful. Results suggest phone surveys may be most effective among similar samples of adolescents.
doi:10.3122/jabfm.2010.04.100019
PMCID: PMC3191874  PMID: 20616296
11.  Impact of spirometry feedback and brief motivational counseling on long term smoking outcomes: A comparison of smokers with and without lung impairment 
Patient education and counseling  2010;80(2):280-283.
Objective
We compared long-term outcomes among smokers with and without impaired lung functioning who received brief counseling highlighting their spirometric test results.
Methods
Participants in this analysis all received a brief motivational intervention for smoking cessation including spirometric testing and feedback (~20 minutes), were advised to quit smoking, offered free access to a phone-based smoking cessation program, and followed for one year. Outcomes were analyzed for smokers with (n = 99) and without (n = 168) impaired lung function.
Results
Participants with lung impairment reported greater use of self-help cessation materials at 6 months, greater use of non-study-provided counseling services at 6 and 12 months, higher 7-day PPA rates at 6 months, and were more likely to talk with their doctor about their spirometry results.
Conclusion
Further research is warranted to determine if spirometry feedback has a differential treatment effect among smokers with and without lung impairment.
Practice Implications
It is premature to make practice recommendations based on these data.
doi:10.1016/j.pec.2009.11.002
PMCID: PMC2897973  PMID: 20434863
smoking cessation; spirometry; motivation; tobacco; health risk assessment; lung age; carbon monoxide; proactive treatment
12.  Smoking Outcome by Psychiatric History after Behavioral and Varenicline Treatment 
Treatment outcomes were compared across smokers enrolled in the COMPASS cessation trial with (PH+, n = 271) and without (PH-, n = 271) a diagnosis of psychiatric history based on medical record evidence of anxiety, depression, psychotic disorder, or bipolar disorder Everyone received behavioral counseling plus varenicline and was followed for 6 months post-quit date. PH+ smokers took varenicline for fewer days on average (59.4 vs. 68.5, P ≤ .01), but did not differ in their use of behavioral treatment. PH+ smokers were more likely to report anxiety and depression, but side-effect intensity ratings did not differ after adjusting for multiple comparisons. Overall, all side-effects were rated as moderate intensity or less. Groups had similar 30 day abstinence rates at 6 months (31.5% PH+ vs. 35.4% PH-, P = .35). In sum, having a psychiatric diagnosis in this trial did not predict worse treatment outcome or worse treatment side-effects.
doi:10.1016/j.jsat.2010.03.007
PMCID: PMC2860053  PMID: 20363092
varenicline; smoking cessation; depression; anxiety; psychiatric illness; side-effects
13.  Evaluation of the PHQ-2 as a Brief Screen for Detecting Major Depression among Adolescents 
Pediatrics  2010;125(5):e1097-e1103.
Objective
To examine the validity of the Patient Health Questionnaire - 2 (PHQ-2), a 2-item depression screening scale among adolescents.
Methods
After completing a brief depression screen, 499 youth (13–17 years) who were enrolled in an integrated healthcare system were invited to participate in a full assessment including a longer depression screening scale (the Patient Health Questionnaire, PHQ-9), a structured mental health interview (the Child Diagnostic Interview Schedule, DISC-IV). Eighty-nine percent (N=444) completed the assessment. Criterion validity and construct validity were tested by examining associations between the PHQ-2 and other measures of depression and functional impairment.
Results
A PHQ-2 score ≥3 had a sensitivity of 74% and specificity of 75% for detecting youth meeting DSM-IV criteria for major depression on the DISC-IV, and a sensitivity of 96% and a specificity of 82% for detecting youth who met criteria for probable major depression on the PHQ-9. On ROC analysis the PHQ-2 had an area under the curve of 0.84 (95% CI = 0.75 to 0.92) and the cut point of 3 was optimal for maximizing sensitivity without loss of specificity for detecting major depression. Youth with a PHQ-2 ≥3 had significantly higher functional impairment scores and significantly higher scores for parent-reported internalizing problems than youth with scores <3.
Conclusion
The PHQ-2 has good sensitivity and specificity for detecting major depression. These properties coupled with the brief nature of the instrument make this tool very promising as a first step for screening for adolescent depression in primary care.
doi:10.1542/peds.2009-2712
PMCID: PMC3100798  PMID: 20368315
Depression; Screening; Adolescence; Primary Care
14.  Behavioral Counseling and Varenicline Treatment for Smoking Cessation 
Background
Smoking remains the primary preventable cause of death and illness in the U.S. Effective, convenient treatment programs are needed to reduce smoking prevalence.
Purpose
This study compared the effectiveness of three modalities of a behavioral smoking-cessation program in smokers using varenicline.
Methods
Current treatment seeking smokers (n=1202) were recruited from a large healthcare organization between October 2006 and October 2007. Eligible participants were randomized to one of three smoking-cessation interventions: web-based counseling (n=401), proactive telephone-based counseling (PTC; n=402), or combined PTC and web counseling (n=399). All participants received a standard 12-week FDA-approved course of varenicline. Self-report determined the primary outcomes (7-day point prevalent abstinence at 3- and 6-month follow-up), the number of days varenicline was taken, and treatment-related symptoms. Behavioral measures determined utilization of both the web- and phone-based counseling.
Results
Intent-to-treat analyses revealed relatively high percentages of abstinence at 3 months (38.9%, 48.5%, 43.4%) and at 6 months (30.7%, 34.3%, 33.8%) for the web, PTC, and PTC web groups, respectively. The PTC group had a significantly higher percentage of abstinence than the web group at 3 months, OR=1.48, 95% CI 1.12–1.96, but no between-group differences in abstinence outcomes were seen at 6 months.
Conclusions
Phone counseling had greater treatment advantage for early cessation and appeared to increase medication adherence, but the absence of differences at 6 months suggests that any of the interventions hold promise when used in conjunction with varenicline.
doi:10.1016/j.amepre.2010.01.024
PMCID: PMC2879135  PMID: 20409497
15.  Feasibility and acceptability of a multiple risk factor intervention: The Step Up randomized pilot trial 
BMC Public Health  2011;11:167.
Background
Interventions are needed which can successfully modify more than one disease risk factor at a time, but much remains to be learned about the acceptability, feasibility, and effectiveness of multiple risk factor (MRF) interventions. To address these issues and inform future intervention development, we conducted a randomized pilot trial (n = 52). This study was designed to assess the feasibility and acceptability of the Step Up program, a MRF cognitive-behavioral program designed to improve participants' mental and physical well-being by reducing depressive symptoms, promoting smoking cessation, and increasing physical activity.
Methods
Participants were recruited from a large health care organization and randomized to receive usual care treatment for depression, smoking, and physical activity promotion or the phone-based Step Up counseling program plus usual care. Participants were assessed at baseline, three and six months.
Results
The intervention was acceptable to participants and feasible to offer within a healthcare system. The pilot also offered important insights into the optimal design of a MRF program. While not powered to detect clinically significant outcomes, changes in target behaviors indicated positive trends at six month follow-up and statistically significant improvement was also observed for depression. Significantly more experimental participants reported a clinically significant improvement (50% reduction) in their baseline depression score at four months (54% vs. 26%, OR = 3.35, 95% CI [1.01- 12.10], p = 0.05) and 6 months (52% vs. 13%, OR = 7.27, 95% CI [1.85 - 37.30], p = 0.004)
Conclusions
Overall, results suggest the Step Up program warrants additional research, although some program enhancements may be beneficial. Key lessons learned from this research are shared to promote the understanding of others working in this field.
Trial registration
The trial is registered with ClinicalTrials.gov (NCT00644995).
doi:10.1186/1471-2458-11-167
PMCID: PMC3072336  PMID: 21414216
16.  Cost-effectiveness of varenicline and three different behavioral treatment formats for smoking cessation 
There is a lack of evidence of the relative cost-effectiveness of proactive telephone counseling (PTC) and Web-based delivery of smoking cessation services in conjunction with pharmacotherapy. We calculated the differential cost-effectiveness of three behavioral smoking cessation modalities with varenicline treatment in a randomized trial of current smokers from a large health system. Eligible participants were randomized to one of three smoking cessation interventions: Web-based counseling (n = 401), PTC (n = 402), or combined PTC-Web counseling (n = 399). All participants received a standard 12-week course of varenicline. The primary outcome was a 7-day point prevalent nonsmoking at the 6 month follow-up. The Web intervention was the least expensive followed by the PTC and PTC-Web groups. Costs per additional 6-month nonsmoker and per additional lifetime quitter were $1,278 and $2,601 for Web, $1,472 and $2,995 for PTC, and $1,617 and $3,291 for PTC-Web. Cost per life-year (LY) and quality-adjusted life-year (QALY) saved were $1,148 and $1,136 for Web, $1,320 and $1,308 for PTC, and $1,450 and $1,437 for PTC-Web. Based on the cost per LY and QALY saved, these interventions are among the most cost-effective life-saving medical treatments. Web, PTC, and combined PTC-Web treatments were all highly cost-effective, with the Web treatment being marginally more cost-effective than the PTC or combined PTC-Web treatments.
doi:10.1007/s13142-010-0009-8
PMCID: PMC3124766  PMID: 21731592
Smoking cessation; Varenicline; Cost-effectiveness; Quality-adjusted life-years saved; Behavioral intervention
18.  Impact of a brief motivational smoking cessation intervention: The Get PHIT trial 
BACKGROUND
Few studies have rigorously evaluated whether providing biologically-based health risk feedback increases smokers’ motivation to quit and long-term abstinence above standard interventions.
DESIGN
Randomized controlled trial conducted from 2005-2008. Data were analyzed in 2008.
SETTING/PARTICIPANTS
Smokers (n = 536) were recruited from the community, regardless of their interest in quitting smoking.
INTERVENTION
Smokers received brief (~20 minutes), personally-tailored counseling based on their lung functioning, carbon monoxide (CO) exposure, and smoking-related health conditions versus generic smoking risk information and personalized counseling about their diet, BMI, and physical activity. All were advised to quit smoking and offered access to a free phone-counseling program.
MAIN OUTCOME MEASURES
Treatment utilization and abstinence at 6 and 12 months post-intervention.
RESULTS
Experimental participants demonstrated no greater motivation to quit, use of treatment services, or abstinence compared to controls at either follow-up. In fact, controls reported greater motivation to quit at 12 months (mean 3.42 vs. 3.20, P = .03), use of pharmacotherapy at 6 months (37.8% vs. 28.0%, P = .02), and 30 day PPA at 6 months after controlling for relevant covariates (10.8% vs. 6.4%, adjusted P = .04).
CONCLUSIONS
The present study found no support for adding a personalized health risk assessment emphasizing lung health and CO exposure to generic cessation advice and counseling for community-based smokers not otherwise seeking treatment.
doi:10.1016/j.amepre.2009.03.018
PMCID: PMC2889910  PMID: 19524389
smoking cessation; spirometry; motivation; tobacco; health risk assessment; lung age; carbon monoxide
19.  IMPACT OF SYMPTOMS EXPERIENCED BY VARENICLINE USERS ON TOBACCO TREATMENT IN A REAL WORLD SETTING 
This paper examines reported symptoms, nonsmoking rates, and medication use among 1018 smokers using varenicline in a randomized trial comparing three forms of behavioral support for smoking cessation (phone, web, or phone + web). One month after beginning varenicline, 168 people (17%) had discontinued the medication. Most (53%) quit due to side-effects and other symptoms. The most common side-effect among all users was nausea (reported by 57% of users). At one month post medication initiation, those not taking varenicline were more likely to report smoking than those who continued the medication (57% vs. 16%, p<.001). Women reported more symptoms but did not discontinue medication at higher rates. Participants who received any telephone counseling (n=681) were less likely to discontinue their medication than those with web support only (15% vs. 21%, p<.01). Counseling may improve tolerance of this medication and reduce the rate of discontinuation due to side-effects. (149 words)
doi:10.1016/j.jsat.2008.09.001
PMCID: PMC2776715  PMID: 19004600
Varenicline; smoking cessation; tobacco dependence treatment
20.  Immediate and short-term impact of a brief motivational smoking intervention using a biomedical risk assessment: The Get PHIT trial 
Nicotine & Tobacco Research  2009;11(4):394-403.
Introduction:
Providing smokers with biologically based evidence of smoking-related disease risk or physical impairment may be an effective way to motivate cessation.
Methods:
Smokers were recruited for a free health risk assessment and randomized to receive personally tailored feedback based on their lung functioning, carbon monoxide (CO) exposure, and smoking-related health conditions or generic information about the risks of smoking and personalized counseling based on their diet, body mass index, and physical activity. All (n = 536) were advised to quit smoking and offered access to a free telephone cessation program. Participants were surveyed immediately after intervention and 1 month later to assess the impact on various indices of motivation to quit.
Results:
Immediately posttreatment, experimental participants rated themselves as more likely to try to quit (p = .02) and reported a greater mean increase in their motivation to quit than controls (p = .04). At 1-month follow-up, however, we found no significant group differences on any motivational indices. In post-hoc analyses comparing smokers in the experimental group with and without lung impairment, persons with impaired lung functioning had a greater change from baseline in posttreatment motivation to quit (adjusted p = .05) and perceived risk of developing a smoking-related disease (p = .03) compared with persons with no lung impairment, but we found no significant treatment effect on any motivational indices at 1 month.
Discussion:
The results suggest that the intervention had a small, temporary effect, but we found no clear evidence that the intervention increased motivation to quit smoking during the first month postintervention.
doi:10.1093/ntr/ntp004
PMCID: PMC2670368  PMID: 19299409
21.  HEALTHCARE SEEKING AND SEXUAL BEHAVIOR AMONG PATIENTS WITH SYMPTOMATIC NEWLY ACQUIRED GENITAL HERPES 
Sexually transmitted diseases  2008;35(12):1015-1021.
SUMMARY
A study on patients seeking healthcare for symptomatic first episode genital herpes found women and men experienced this infection differently, but both frequently continued sexual activity after onset of symptoms.
Background
Symptoms among patients with first episode HSV likely influence health seeking and sexual behavior. An improved understanding of this relationship provides insight into the experience of having genital herpes and has implications of counseling.
Objective
To describe the healthcare seeking and sexual behavior in a group of patients with symptomatic laboratory confirmed first episode HSV infection.
Methods
Two hundred thirty-six patients (94 men 142 women) with newly acquired genital herpes were asked to complete a demographic and sexual history questionnaire. To confirm initial HSV diagnosis, swabs of lesions were collected for viral culture and HSV DNA PCR, and blood was drawn for confirmation of HSV serostatus using the Western blot.
Results
Women reported pain and men reported lesions as the most frequent and bothersome symptom or sign causing each to seek healthcare. Forty-three percent of all participants missed some work or school because of their symptoms; women missed more school or work, sought care sooner and saw more providers than men. Prior to diagnosis, most respondents (67%) suspected genital herpes was the etiology of the symptoms. Twenty-seven percent reported having sex after noticing their symptoms, though those who missed more school or work were less likely to engage in sexual intercourse.
Conclusions
Men and women have different experiences with first episode HSV, but morbidity is substantial, especially among women. Both men and women may continue to engage in sexual activity after onset of genital herpes, emphasizing the need for providers to counsel their patients to avoid exposing partners to the infection.
doi:10.1097/OLQ.0b013e318182a596
PMCID: PMC2710803  PMID: 18685544
HSV; genital herpes; first episode; behaviors; symptoms
22.  Clinical trial participant characteristics and saliva and DNA metrics 
Background
Clinical trial and epidemiological studies need high quality biospecimens from a representative sample of participants to investigate genetic influences on treatment response and disease. Obtaining blood biospecimens presents logistical and financial challenges. As a result, saliva biospecimen collection is becoming more frequent because of the ease of collection and lower cost. This article describes an assessment of saliva biospecimen samples collected through the mail, trial participant demographic and behavioral characteristics, and their association with saliva and DNA quantity and quality.
Methods
Saliva biospecimens were collected using the Oragene® DNA Self-Collection Kits from participants in a National Cancer Institute funded smoking cessation trial. Saliva biospecimens from 565 individuals were visually inspected for clarity prior to and after DNA extraction. DNA samples were then quantified by UV absorbance, PicoGreen®, and qPCR. Genotyping was performed on 11 SNPs using TaqMan® SNP assays and two VNTR assays. Univariate, correlation, and analysis of variance analyses were conducted to observe the relationship between saliva sample and participant characteristics.
Results
The biospecimen kit return rate was 58.5% among those invited to participate (n = 967) and 47.1% among all possible COMPASS participants (n = 1202). Significant gender differences were observed with males providing larger saliva volume (4.7 vs. 4.5 ml, p = 0.019), samples that were more likely to be judged as cloudy (39.5% vs. 24.9%, p < 0.001), and samples with greater DNA yield as measured by UV (190.0 vs. 138.5, p = 0.002), but reduced % human DNA content (73.2 vs. 77.6 p = 0.005) than females. Other participant characteristics (age, self-identified ethnicity, baseline cigarettes per day) were associated with saliva clarity. Saliva volume and saliva and DNA clarity were positively correlated with total DNA yield by all three quantification measurements (all r > 0.21, P < 0.001), but negatively correlated with % human DNA content (saliva volume r = -0.148 and all P < 0.010). Genotyping completion rate was not influenced by saliva or DNA clarity.
Conclusion
Findings from this study show that demographic and behavioral characteristics of smoking cessation trial participants have significant associations with saliva and DNA metrics, but not with the performance of TaqMan® SNP or VNTR genotyping assays.
Trial registration
COMPASS; registered as NCT00301145 at clinicaltrials.gov.
doi:10.1186/1471-2288-9-71
PMCID: PMC2776600  PMID: 19874586
23.  Mood, Side-effects and Smoking Outcomes Among Persons With and Without Probable Lifetime Depression Taking Varenicline 
ABSTRACT
BACKGROUND
Varenicline may be associated with greater mood disturbance and side-effects among smokers with psychiatric history, but empirical evidence is limited. Differential treatment effectiveness by psychiatric history may also exist.
OBJECTIVE
To compare mood, prevalence and intensity of treatment side-effects, and abstinence among people with a probable history of major depression (DH+) or not (DH−) who took varenicline and received behavioral smoking cessation treatment.
DESIGN
Smokers participated in a randomized behavioral intervention effectiveness trial. Treatment side-effects and outcomes were compared between DH+ and DH− participants (n = 1,117) at 2 days and 3 months after the target quit date.
PARTICIPANTS
Smokers recruited from a large regional health plan.
MEASUREMENTS
Change in stress and depression scores, prevalence and intensity of treatment side-effects, and abstinence rates.
RESULTS
All side-effects averaged moderate intensity or less and were similar across DH groups, except DH+’s endorsed slightly worse confusion, nausea (adjusted P = 0.04) and trouble sleeping (adjusted P = 0.008) at 21 days. Depression and stress scores declined in both DH groups and an equal proportion of each evidenced new/worsening depressive symptoms. Despite few differences in symptom intensity, more DH+ participants reported recent tension/agitation, irritability/anger, confusion, and depression at 21 days (adjusted P < 0.05), and depression and anxiety (adjusted P < 0.01) at three months. Nonsmoking rates did not differ by DH group at follow-up.
CONCLUSION
While some group differences were noted, DH+ smokers did not report qualitatively worse neuropsychiatric symptoms, more new/worsening mood disturbance, or differential abstinence rates compared to DH- smokers.
doi:10.1007/s11606-009-0926-8
PMCID: PMC2669860  PMID: 19238488
depression; varenicline; smoking

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