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1.  Alcohol and Associated Characteristics among Older Persons Living with HIV on Antiretroviral Therapy 
Background
Alcohol use, and particularly unhealthy alcohol use, is associated with poor HIV-related outcomes among persons living with HIV (PLWH). Despite a rapidly growing proportion of PLWH ≥50 years, alcohol use and its associated characteristics are under-described in this population. We describe alcohol use, severity, and associated characteristics using data from a sample of PLWH ≥50 years who participated in a trial of a telephone-based intervention to improve adherence to ART.
Methods
Participants were recruited from AIDS Service Organizations in 9 states and included PLWH ≥50 years who were prescribed ART, reported suboptimal adherence at screening (missing >1.5 days of medication or taking medications 2 hours early or late on >3 days in the 30 days prior to screening), and consented to participate. The AUDIT-C alcohol screen, socio-demographic characteristics, substance use and mental health comorbidity were assessed at baseline. AUDIT-C scores were categorized into non-drinking, low-level drinking, and mild-moderate unhealthy, and severe unhealthy drinking (0, 1-3, 4-6, 7-12, respectively). Analyses described and compared characteristics across drinking status (any/none) and across AUDIT-C categories among drinkers.
Results
Among 447 participants, 57% reporting drinking alcohol in the past year, including 35%, 15% and 7% reporting low-level drinking, mild-moderate unhealthy drinking, and severe unhealthy drinking, respectively. Any drinking was most common among men and those who were LGBT, married/partnered, had received past-year alcohol treatment, and never used injection drugs (p-values all <0.05). Differences in race, employment status, past year alcohol treatment, and positive depression screening (p-values all <0.05) were observed across AUDIT-C categories.
Conclusions
In this sample of older PLWH with suboptimal ART adherence, a majority reported past-year alcohol use and 22% screened positive for unhealthy alcohol use. Any and unhealthy alcohol use were associated with demographics, depression, and substance use history. Further research is needed regarding alcohol use among older PLWH.
doi:10.1080/08897077.2014.890997
PMCID: PMC4249664  PMID: 24625188
Alcohol; HIV; Older adults
3.  Pharmacogenetic Smoking Cessation Intervention in a Health Care Setting: A Pilot Feasibility Study 
Nicotine & Tobacco Research  2012;15(2):518-526.
Introduction:
There is increasing evidence that response to pharmacological treatment for nicotine dependence may be moderated by genetic polymorphisms. However, the feasibility, acceptability, and impact of genetically tailoring treatment in real-world clinical settings are unknown.
Methods:
We conducted a multiphased, mixed-methods feasibility study with current smokers to develop and evaluate a patient-centered, theoretically grounded personalized medicine treatment protocol. The initial research phase included formative work to develop intervention materials. The second phase included a randomized pilot trial to evaluate the intervention. Trial participants (n = 36) were genotyped for ANKK1 rs1800497 and were randomized to receive genetic feedback (GF) plus standard behavioral counseling (BC) for smoking cessation or BC without GF. All participants received genetically tailored pharmacotherapy (nicotine patch or bupropion).
Results:
The intervention was feasible to implement and was acceptable to participants based on satisfaction ratings and objective measures of participation. There was no evidence that the GF resulted in adverse psychological outcomes (e.g., depression, fatalism, reduced perceived control over quitting, differential motivation for quitting) based on quantitative or qualitative outcomes.
Conclusions:
Study results suggest that it is feasible to offer treatment within a health care setting that includes genetically tailored pharmacotherapy and doing so had no apparent adverse psychological impacts. Further evaluation of pharmacogenetically tailored smoking cessation interventions appears warranted.
doi:10.1093/ntr/nts173
PMCID: PMC3611995  PMID: 22949583
4.  Using Multiple Imputations to Accommodate Time-Outs in Online Interventions 
Background
Accurately estimating the period of time that individuals are exposed to online intervention content is important for understanding program engagement. This can be calculated from time-stamped data reflecting navigation to and from individual webpages. Prolonged periods of inactivity are commonly handled with a time-out feature and assigned a prespecified exposure duration. Unfortunately, this practice can lead to biased results describing program exposure.
Objective
The aim of the study was to describe how multiple imputations can be used to better account for the time spent viewing webpages that result in a prolonged period of inactivity or a time-out.
Methods
To illustrate this method, we present data on time-outs collected from the Q2 randomized smoking cessation trial. For this analysis, we evaluate the effects on intervention exposure of receiving content written in a prescriptive versus motivational tone. Using multiple imputations, we created five complete datasets in which the time spent viewing webpages that resulted in a time-out were replaced with values estimated with imputation models. We calculated standard errors using Rubin’s formulas to account for the variability due to the imputations. We also illustrate how current methods of accounting for time-outs (excluding timed-out page views or assigning an arbitrary viewing time) can influence conclusions about participant engagement.
Results
A total of 63.00% (1175/1865) of participants accessed the online intervention in the Q2 trial. Of the 6592 unique page views, 683 (10.36%, 683/6592) resulted in a time-out. The median time spent viewing webpages that did not result in a time-out was 1.07 minutes. Assuming participants did not spend any time viewing a webpage that resulted in a time-out, no difference between the two message tones was observed (ratio of mean time online: 0.87, 95% CI 0.75-1.02). Assigning 30 minutes of viewing time to all page views that resulted in a time-out concludes that participants who received content in a motivational tone spent less time viewing content (ratio of mean time online: 0.86, 95% CI 0.77-0.98) than those participants who received content in a prescriptive tone. Using multiple imputations to account for time-outs concludes that there is no difference in participant engagement between the two message tones (ratio of mean time online: 0.87; 95% CI 0.75-1.01).
Conclusions
The analytic technique chosen can significantly affect conclusions about online intervention engagement. We propose a standardized methodology in which time spent viewing webpages that result in a time-out is treated as missing information and corrected with multiple imputations.
Trial Registration
Clinicaltrials.gov NCT00992264; http://clinicaltrials.gov/ct2/show/NCT00992264 (Archived by WebCite at http://www.webcitation.org/6Kw5m8EkP).
doi:10.2196/jmir.2781
PMCID: PMC3841344  PMID: 24263289
online interventions; engagement; time spent online; multiple imputations; automatic time-out; smoking cessation; utilization; behavioral research; Internet
5.  Understanding Oral Health Promotion Needs and Opportunities of Tobacco Quitline Callers 
Public Health Reports  2012;127(4):401-406.
SYNOPSIS
Objective
Improving oral health and oral health care are important public health goals. Tobacco users and smokers are at particularly high risk for oral disease and warrant targeted intervention efforts. We assessed the need for and acceptability of targeting tobacco quitline callers for an oral health promotion intervention.
Methods
We surveyed 816 Washington State Quitline callers to assess their oral health, relevant self-care behaviors, and interest in oral health promotion intervention.
Results
Most respondents were female, cigarette smokers, of low socioeconomic status, with no dental insurance. Of the respondents, 79.3% (n=647) had some or all of their natural teeth (e.g., dentate); however, most of these respondents failed to meet recommendations for daily oral hygiene (brushing and flossing) (83.9%, n=543) and had no dental visits in the past year (52.6%, n=340). Similar findings were observed among respondents with no insurance. Many respondents were interested in learning more about how to improve their oral health (57.4%, n=468), willing to speak with a quitline coach about improving their oral health (48.2%, n=393), and open to receiving additional oral health information by mail (62.7%, n=512) or the Internet (50.0%, n=408). People who were receptive to learning how to improve their oral health were significantly more likely to be nonwhite, have a low income, have no dental insurance, and not have visited a dentist in the past year.
Conclusion
There is a need and an opportunity to target quitline callers for oral health promotion services, as those most in need of these services were open to receiving them.
PMCID: PMC3366377  PMID: 22753983
6.  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
7.  Results from a randomized trial of a web-based, tailored decision aid for women at high risk for breast cancer 
Patient education and counseling  2013;91(3):364-371.
Objective
To assess the impact of Guide to Decide (GtD), a web-based, personally-tailored decision aid designed to inform women’s decisions about prophylactic tamoxifen and raloxifene use.
Methods
Postmenopausal women, age 46–74, with BCRAT 5-year risk ≥1.66% and no prior history of breast cancer were randomized to one of three study arms: intervention (n = 690), Time 1 control (n = 160), or 3-month control (n = 162). Intervention participants viewed GtD prior to completing a post-test and 3 month follow-up assessment. Controls did not. We assessed the impact of GtD on women’s decisional conflict levels and treatment decision behavior at post-test and at 3 months, respectively.
Results
Intervention participants had significantly lower decisional conflict levels at post-test (p < 0.001) and significantly higher odds of making a decision about whether or not to take prophylactic tamoxifen or raloxifene at 3-month follow-up (p < 0.001) compared to control participants.
Conclusion
GtD lowered decisional conflict and helped women at high risk of breast cancer decide whether to take prophylactic tamoxifen or raloxifene to reduce their cancer risk.
Practice implications
Web-based, tailored decision aids should be used more routinely to facilitate informed medical decisions, reduce patients’ decisional conflict, and empower patients to choose the treatment strategy that best reflects their own values.
doi:10.1016/j.pec.2012.12.014
PMCID: PMC3650477  PMID: 23395006
Decision aids; Tamoxifen; Raloxifene; Breast cancer prevention; Tailoring
8.  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
9.  Alcohol Consumption and Urges to Smoke among Women during a Smoking Cessation Attempt 
Experimental and clinical psychopharmacology  2013;21(1):10.1037/a0031009.
Laboratory and ad libitum smoking studies have indicated that alcohol consumption increases the frequency and intensity of smoking urges. However, few studies have examined the relation between smoking urges and alcohol use in natural settings during a quit attempt. The purpose of this study was to examine the relationships between smoking urge and alcohol use in women who reported drinking on at least one occasion during the first 7 days of a smoking quit attempt (N = 134). Participants were asked to use a palmtop computer to complete assessments that recorded smoking urges and recent alcohol use. Multilevel analyses examined the relation between smoking urge parameters and alcohol use. Smoking urges were higher during assessments where alcohol had been recently consumed compared to assessments where no alcohol had been consumed. Interestingly, the first urge rating of the day was higher and urges were more volatile on days where alcohol would eventually be consumed as compared to days where no alcohol was consumed. A closer examination of urge parameters on drinking days indicated that smoking urge trajectory was significantly flatter and urge volatility was significantly higher following alcohol consumption. However, smoking urge trajectory also flattened later in the day on nondrinking days. The findings suggest that there may be reciprocal relations between smoking urge and alcohol use (e.g., higher initial urges and more volatile urges may increase the likelihood of alcohol use; and, alcohol use may impact within day smoking urge parameters), and these relations could potentially impact smoking cessation and relapse.
doi:10.1037/a0031009
PMCID: PMC3854865  PMID: 23379613
Smoking; Smoking urge; Alcohol; Ecological Momentary Assessment; Multilevel Analysis
10.  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
11.  Breast cancer anxiety’s associations with responses to a chemoprevention decision aid 
Few studies have examined how specific emotions may affect decision-making processes. Anxiety may be especially relevant in health decisions such as those related to cancer in which thoughts of illness or death may be abundant. We examined associations between women’s anxiety about developing breast cancer and variables related to their decision to take a medication that could reduce their chances of the disease. Six-hundred and thirty-two American women, who had an increased risk of breast cancer, reviewed a web-based decision aid about tamoxifen. We examined associations between their baseline, self-reported anxiety about developing the disease and post decision aid measures including knowledge about tamoxifen, attitude toward the medication, and behavioral intentions to look for more information and take the medication. Results showed that anxiety was not associated with knowledge about tamoxifen, but it was associated with attitude toward the medication such that women who were more anxious about developing breast cancer were more likely to think the benefits were worth the risks. Greater anxiety was also associated with greater behavioral intentions to look for additional information and take the medication in the next few months. Secondary analyses showed that behavioral intentions were related to knowledge of tamoxifen and attitude toward the medication only for women who were reporting low levels of anxiety. Overall, the findings suggest that anxiety about breast cancer may motivate interest in tamoxifen and not necessarily through affecting knowledge or attitudes.
doi:10.1016/j.socscimed.2012.10.009
PMCID: PMC3760790  PMID: 23200299
U.S.; Anxiety; Behavioral decision-making; Breast cancer; Tamoxifen
12.  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
13.  Recruitment to a Randomized Web-Based Nutritional Intervention Trial: Characteristics of Participants Compared to Non-Participants 
Background
Web-based behavioral programs efficiently disseminate health information to a broad population, and online tailoring may increase their effectiveness. While the number of Internet-based behavioral interventions has grown in the last several years, additional information is needed to understand the characteristics of subjects who enroll in these interventions, relative to those subjects who are invited to enroll.
Objective
The aim of the study was to compare the characteristics of participants who enrolled in an online dietary intervention trial (MENU) with those who were invited but chose not to participate, in order to better understand how these groups differ.
Methods
The MENU trial was conducted among five health plans participating in the HMO Cancer Research Network in collaboration with the University of Michigan Center for Health Communication Research. Approximately 6000 health plan members per site, between the ages of 21 and 65, and stratified by gender with oversampling of minority populations, were randomly selected for recruitment and were mailed an invitation letter containing website information and a US$2 bill with the promise of US$20 for completing follow-up surveys. Administrative and area-based data using geocoding along with baseline survey data were used to compare invitees (HMO members sent the introductory letter), responders (those who entered a study ID on the website), and enrollees (those who completed the enrollment process). Generalized estimating equation multivariate and logistic regression models were used to assess predictors of response and enrollment.
Results
Of 28,460 members invited to participate, 4270 (15.0%) accessed the website. Of the eligible responders, 2540 (8.9%) completed the consent form and baseline survey and were enrolled and randomized. The odds of responding were 10% lower for every decade of increased age (P < .001), while the likelihood of enrolling was 10% higher for every decade increase in age (P < .001). Women were more likely to respond and to enroll (P < .001). Those living in a census tract associated with higher education levels were more likely to respond and enroll, as well as those residing in tracts with higher income (P < .001). With a 22% (n = 566) enrollment rate for African Americans and 8% (n = 192) for Hispanics, the enrolled sample was more racially and ethnically diverse than the background sampling frame.
Conclusions
Relative to members invited to participate in the Internet-based intervention, those who enrolled were more likely to be older and live in census tracts associated with higher socioeconomic status. While oversampling of minority health plan members generated an enrolled sample that was more racially and ethnically diverse than the overall health plan population, additional research is needed to better understand methods that will expand the penetration of Internet interventions into more socioeconomically diverse populations.
Trial Registration
Clinicaltrials.gov NCT00169312; http://clinicaltrials.gov/ct2/show/NCT00169312 (Archived by WebCite at http://www.webcitation.org/5jB50xSfU)
doi:10.2196/jmir.1086
PMCID: PMC2762858  PMID: 19709990
Recruitment; Web-based interventions; making effective nutritional choices; Cancer Research Network; CRN; fruits and vegetables; research subject selection; selection; patient; mass screening; Internet; motivation; cultural diversity; health maintenance organizations
14.  The Distinct Role of Comparative Risk Perceptions in a Breast Cancer Prevention Program 
Background
Comparative risk perceptions may rival other types of information in terms of effects on health behavior decisions.
Purpose
We examined associations between comparative risk perceptions, affect, and behavior while controlling for absolute risk perceptions and actual risk.
Methods
Women at an increased risk of breast cancer participated in a program to learn about tamoxifen which can reduce the risk of breast cancer. Women reported comparative risk perceptions of breast cancer and completed measures of anxiety, knowledge, and tamoxifen-related behavior intentions. Three months later, women reported their behavior.
Results
Comparative risk perceptions were positively correlated with anxiety, knowledge, intentions, and behavior three months later. After controlling for participants’ actual risk of breast cancer and absolute risk perceptions, comparative risk perceptions predicted anxiety and knowledge, but not intentions or behavior.
Conclusions
Comparative risk perceptions can affect patient outcomes like anxiety and knowledge independently of absolute risk perceptions and actual risk information.
doi:10.1007/s12160-011-9287-8
PMCID: PMC3760792  PMID: 21698518
comparative risk perception; breast cancer; behavioral decision-making; tamoxifen; decision aid
15.  Informed choice about breast cancer prevention: randomized controlled trial of an online decision aid intervention 
Introduction
Tamoxifen and raloxifene are chemopreventive drugs that can reduce women's relative risk of primary breast cancer by 50%; however, most women eligible for these drugs have chosen not to take them. The reasons for low uptake may be related to women's knowledge or attitudes towards the drugs. We aimed to examine the impact of an online breast cancer chemoprevention decision aid (DA) on informed intentions and decisions of women at high risk of breast cancer.
Methods
We conducted a randomized clinical trial, assessing the effect of a DA about breast cancer chemoprevention on informed choices about chemoprevention. Women (n = 585), 46- to 74-years old old, completed online baseline, post-test, and three-month follow-up questionnaires. Participants were randomly assigned to either an intervention group, a standard control group that answered questions about chemoprevention at baseline, or a three-month control group that did not answer questions about chemoprevention at baseline. The main outcome measures were whether women's intentions and decisions regarding chemoprevention drugs were informed, and whether women who viewed the DA were more likely to make informed decisions than women who did not view the DA, using a dichotomous composite variable 'informed choice' (yes/no) to classify informed decisions as those reflecting sufficient knowledge and concordance between a woman's decision and relevant attitudes.
Results
Analyses showed that more intervention than standard control participants (52.7% versus 5.9%) made informed decisions at post-test, P <0.001. At the three-month follow-up, differences in rates of informed choice between intervention (16.9%) and both control groups (11.8% and 8.0%) were statistically non-significant, P = 0.067.
Conclusions
The DA increased informed decision making about breast cancer chemoprevention, although the impact on knowledge diminished over time. This study was not designed to determine how much knowledge decision makers must retain over time. Examining informed decisions increases understanding of the impact of DAs. A standard for defining and measuring sufficient knowledge for informed decisions is needed.
Trial registration
ClinicalTrials.gov: NCT00967824
doi:10.1186/bcr3468
PMCID: PMC3978729  PMID: 24004815
16.  Women’s interest in taking tamoxifen and raloxifene for breast cancer prevention: Response to a tailored decision aid 
Although tamoxifen can prevent primary breast cancer, few women use it as a preventive measure. A second option, raloxifene, has recently been approved. The objective of the study was to determine women’s interest in tamoxifen and raloxifene after reading a decision aid describing the risks and benefits of each medication. Women with 5-year risk of breast cancer ≥1.66 from two large health maintenance organizations were randomized to receive a decision aid versus usual care. After reading an on-line decision aid that discussed the risks and benefits of tamoxifen and raloxifene, women completed measures of risk perception, decisional conflict, behavioral intentions and actual behavior related to tamoxifen and raloxifene. 3 months following the intervention, 8.1% of participants had looked for additional information about breast cancer prevention drugs and 1.8% had talked to their doctor about tamoxifen and/or raloxifene. The majority, 54.7%, had decided to not take either drug, 0.5% had started raloxifene, and none had started tamoxifen. Participants were not particularly worried about taking tamoxifen or raloxifene and did not perceive significant benefits from taking these drugs. Over 50% did not perceive a change in their risk of getting breast cancer if they took tamoxifen or raloxifene. After reading a DA about tamoxifen and raloxifene, few women were interested in taking either breast cancer prevention drug.
doi:10.1007/s10549-011-1450-1
PMCID: PMC3742062  PMID: 21442198
decision aids; patient education; tamoxifen; raloxifene; breast cancer prevention
17.  Women’s decisions regarding tamoxifen for breast cancer prevention: Responses to a tailored decision aid 
Background
Tamoxifen reduces primary breast cancer incidence, yet has serious side effects. To date, few women with increased breast cancer risk have elected to use tamoxifen for chemoprevention. The objective of the study was to determine women’s knowledge of and attitudes toward tamoxifen following exposure to a tailored decision aid (DA).
Methods
632 women with a 5-year risk of breast cancer ≥1.66% (Mean=2.56, range=1.7-17.3) were recruited from 2 healthcare organizations. Participants viewed an online DA that informed them about their 5-year risk of breast cancer and presented individually-tailored content depicting the risks/benefits of tamoxifen prophylaxis. Outcome measures included behavioral intentions (to seek additional information about tamoxifen, to talk to a physician about tamoxifen, and to take tamoxifen); knowledge; and perceived risks and benefits of tamoxifen.
Results
After viewing the DA, 29% of participants said they intended to seek more information or talk to their doctor about tamoxifen, and only 6% believed they would take tamoxifen. Knowledge was considerable, with 63% of women answering at least 5 of 6 knowledge questions correctly. Participants were concerned about the risks of tamoxifen and many believed that the benefits of tamoxifen did not outweigh the risks.
Conclusions
This study is the largest to date to test women’s preferences for taking tamoxifen and one of the largest to have tested the impact of a tailored decision aid. After viewing the DA, women demonstrated good understanding of tamoxifen’s risks and benefits, but most were not interested in taking tamoxifen for breast cancer chemoprevention.
doi:10.1007/s10549-009-0618-4
PMCID: PMC3736824  PMID: 19908143
decision aids; patient education; tamoxifen; breast cancer prevention
18.  Interest in an Online Smoking Cessation Program and Effective Recruitment Strategies: Results From Project Quit 
Background
The Internet is a promising venue for delivering smoking cessation treatment, either as a stand-alone program or as an adjunct to pharmacotherapy. However, there is little data to indicate what percent of smokers are interested in receiving online smoking cessation services or how best to recruit smokers to Internet-based programs.
Objective
Using a defined recruitment sample, this study aimed to identify the percentage of smokers who expressed interest in or enrolled in Project Quit, a tailored, online, cognitive-behavioral support program offered with adjunctive nicotine replacement therapy patches. In addition, we examined the effectiveness of several individual-level versus population-level recruitment strategies.
Methods
Members from two large health care organizations in the United States were invited to participate in Project Quit. Recruitment efforts included proactive invitation letters mailed to 34533 likely smokers and reactive population-level study advertisements targeted to all health plan members (> 560000 adults, including an estimated 98000 smokers across both health care organizations).
Results
An estimated 1.6% and 2.5% of adult smokers from each health care organization enrolled in Project Quit. Among likely smokers who received proactive study invitations, 7% visited the Project Quit website (n = 2260) and 4% (n = 1273) were eligible and enrolled. Response rates were similar across sites, despite using different sources to assemble the invitation mailing list. Proactive individual-level recruitment was more effective than other forms of recruitment, accounting for 69% of website visitors and 68% of enrollees.
Conclusions
Smokers were interested in receiving online smoking cessation support, even though they had access to other forms of treatment through their health insurance. Uptake rates for this program were comparable to those seen when smokers are advised to quit and are referred to other forms of smoking cessation treatment. In this sample, proactive mailings were the best method for recruiting smokers to Project Quit.
doi:10.2196/jmir.8.3.e14
PMCID: PMC2018826  PMID: 16954124
Internet; tobacco dependence; nicotine dependence; smoking cessation; recruitment activities
19.  [More] evidence to support oral health promotion services targeted to smokers calling tobacco quitlines in the United States 
BMC Public Health  2013;13:336.
Background
Prior research demonstrated a need and opportunity to target smokers calling a free, state-funded tobacco quitline to provide behavioral counseling for oral health promotion; however, it is unclear whether these results generalize to tobacco quitline callers of higher socioeconomic status receiving services through commercially-funded quitlines. This knowledge will inform planning for a future public oral health promotion program targeted to tobacco quitline callers.
Methods
We surveyed smokers (n = 455) who had recently received tobacco quitline services through their medical insurance. Participants were asked about their self-reported oral health indicators, key behavioral risk factors for oral disease, motivation for changing their oral self-care behavior, and interest in future oral health promotion services. Where applicable, results were compared against those from a representative sample of callers to a free, state-funded quitline (n = 816) in the same geographic region.
Results
Callers to a commercially-funded quitline had higher socioeconomic status, were more likely to have dental insurance, and reported better overall oral health indicators and routine self-care (oral hygiene, dental visits) than callers to a state-funded quitline. Nevertheless opportunities for oral health promotion were identified. Nearly 80% of commercial quitline callers failed to meet basic daily hygiene recommendations, 32.8% had not visited the dentist in more than a year, and 63.3% reported daily alcohol consumption (which reacts synergistically with tobacco to increase oral cancer risk). Nearly half (44%) were interested in learning how to improve their oral health status and, on average, moderately high levels of motivation for oral health care were reported. Many participants also had dental insurance, eliminating an important barrier to professional dental care.
Conclusions
Future public oral health promotion efforts should focus on callers to both free state-supported and commercially-funded tobacco quitlines. While differences exist between these populations, both groups report behavioral risk factors for oral disease which represent important targets for intervention.
doi:10.1186/1471-2458-13-336
PMCID: PMC3635972  PMID: 23577873
Oral health promotion; Smoking; Tobacco; Oral disease
20.  Using Body Mass Index Data in the Electronic Health Record to Calculate Cardiovascular Risk 
Background
Multivariable cardiovascular disease (CVD) risk calculators, such as the Framingham risk equations, can be used to identify populations most likely to benefit from treatments to decrease risk.
Purpose
To determine the proportion of adults within an electronic health record (EHR) for whom Framingham CVD risk scores could be calculated using cholesterol (lab-based) and/or BMI (BMI-based) formulae.
Methods
EHR data were used to identify patients aged 30–74 years with no CVD and at least 2 years continuous enrollment prior to April 1, 2010 and relevant data from the preceding 5-year time frame. Analyses were conducted between 2010 and 2011 to determine the proportion of patients with a lab- or BMI-based risk score, the data missing, and the concordance between scores.
Results
Of 122,270 eligible patients, 59.7% (n=73,023) had sufficient data to calculate the lab-based risk score and 84.1% (102,795) the BMI-based risk score. Risk categories were concordant in 78.2% of patients. When risk categories differed, BMI-based risk was almost always in a higher category, with 20.3% having a higher and 1.4% a lower BMI- than lab-based risk score. Concordance between lab- and BMI-based risk was greatest among those at lower estimated risk, including people who were younger, female, without diabetes, not obese, and those not on blood pressure –or lipid-lowering medications
Conclusions
EHR data can be used to classify CVD risk for most adults aged 30–74 years. In the population for the current study, CVD risk scores based on BMI could be used to identify those at low risk for CVD and potentially reduce unnecessary laboratory cholesterol testing.
Trial registration
This study is registered at clinicaltrials.gov NCT01077388.
doi:10.1016/j.amepre.2011.12.009
PMCID: PMC3308122  PMID: 22424246
21.  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
22.  Dopamine genes and nicotine dependence in treatment seeking and community smokers 
We utilized a cohort of 828 treatment seeking self-identified white cigarette smokers (50% female) to rank candidate gene single nucleotide polymorphisms (SNPs) associated with the Fagerström Test for Nicotine Dependence (FTND), a measure of nicotine dependence which assesses quantity of cigarettes smoked and time- and place-dependent characteristics of the respondent’s smoking behavior. 1123 SNPs at 55 autosomal candidate genes, nicotinic acetylcholine receptors and genes involved in dopaminergic function, were tested for association to baseline FTND scores adjusted for age, depression, education, sex and study site. SNP P values were adjusted for the number of transmission models, the number of SNPs tested per candidate gene, and their intragenic correlation. DRD2, SLC6A3 and NR4A2 SNPs with adjusted P values < 0.10 were considered sufficiently noteworthy to justify further genetic, bioinformatic and literature analyses. Each independent signal among the top-ranked SNPs accounted for ~1% of the FTND variance in this sample. The DRD2 SNP appears to represent a novel association with nicotine dependence. The SLC6A3 SNPs have previously been shown to be associated with SLC6A3 transcription or dopamine transporter density in vitro, in vivo and ex vivo. Analysis of SLC6A3 and NR4A2 SNPs identified a statistically significant gene-gene interaction (P=0.001), consistent with in vitro evidence that the NR4A2 protein product (NURR1) regulates SLC6A3 transcription. A community cohort of N=175 multiplex ever smoking pedigrees (N=423 ever smokers) provided nominal evidence for association with the FTND at these top ranked SNPs, uncorrected for multiple comparisons.
doi:10.1038/npp.2009.52
PMCID: PMC3558036  PMID: 19494806
dopamine transporter; Fagerström Test for Nicotine Dependence; single nucleotide polymorphism; candidate gene association scan; gene-gene interaction
23.  Early Cessation Success or Failure among Women Attempting to Quit Smoking: Trajectories and Volatility of Urge and Negative Mood during the First Post-cessation Week 
Journal of abnormal psychology  2011;120(3):596-606.
Aversive symptoms of abstinence from nicotine have been posited to lead to smoking relapse and research on temporal patterns of abstinence symptoms confirms this assumption. However, little is known about the association of symptom trajectories early after quitting with post-cessation smoking or about the differential effects of tonic (background) versus phasic (temptation-related) symptom trajectories on smoking status. The current study examined trajectories of urge and negative mood among 300 women using the nicotine patch during the first post-cessation week. Ecological momentary assessments collected randomly and during temptation episodes were analyzed using hierarchical linear modeling yielding four individual trajectory parameters: intercept (initial symptom level), linear slope (direction and rate of change), quadratic coefficient (curvature), and volatility (scatter). Early lapsers, who lapsed during the first post-cessation week, exhibited more severe tonic urge and phasic negative mood immediately after quitting, and more volatile tonic and phasic urge compared to abstainers. Late lapsers, who were abstinent during the first week but lapsed by 1 month, exhibited more severe tonic urge immediately after quitting compared to abstainers. These results demonstrate the importance of early post-cessation urge and negative affect and highlight the value of examining both tonic and phasic effects of abstinence from nicotine.
doi:10.1037/a0023755
PMCID: PMC3153568  PMID: 21574667
Early post-cessation symptoms; Withdrawal trajectory; Volatility; Urge; Negative Mood; Lapser; Ecological Momentary Assessment
24.  The Efficacy of Computer-Delivered Treatment for Smoking Cessation 
Background
The current study evaluated the efficacy of an individualized, hand-held Computer-Delivered Treatment (CDT) versus Standard Treatment (ST) for the maintenance of smoking abstinence following a quit attempt.
Methods
Participants were 303 adult daily smokers randomized to CDT or ST, plus pharmacotherapy. Abstinence though one year was examined using logistic random intercept models, a type of generalized linear mixed model regression.
Results
Results did not support the efficacy of the CDT program through one year post-quit in analyses adjusted for time and study site [OR = .84, 95% CI = .55–1.30], or after further adjusting for race/ethnicity, age, gender, education, marital status, and the number of cigarettes smoked per day before quitting [OR = .89, 95% CI = .57–1.39].
Conclusions
CDT did not increase short- or long-term abstinence rates over ST in this study.
Impact Statement
Findings differ from some in the literature and suggest the need for continued research on the use of CDT for smoking cessation.
doi:10.1158/1055-9965.EPI-11-0390
PMCID: PMC3132322  PMID: 21613389
25.  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

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