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Biomedical subjects

Judith K Ockene

Publications and source records attributed to Judith K Ockene.

At least 19 recordsLinked to original sources

Sustainability of public health programs: the example of tobacco treatment services in Massachusetts.

Sustaining important public or grant-funded services after initial funding is terminated is a major public health challenge. We investigated whether tobacco treatment services previously funded within a statewide tobacco control initiative could be sustained after state funding was terminated abruptly. We found that 2 key strategies-redefining the scope of services being offered and creative use of resources-were factors that determined whether some community agencies were able to sustain services at a much higher level than others after funding was discontinued. Understanding these strategies and developing them at a time when program funding is not being threatened is likely to increase program sustainability.

Community Health Centers↗

Effects of combination estrogen plus progestin hormone treatment on cognition and affect.

CONTEXT: Some studies of hormone treatment in postmenopausal women suggest benefits on specific cognitive functions, particularly memory. OBJECTIVE: The objective of this study was to determine whether hormone therapy influences changes in specific cognitive functions and affect in older women. DESIGN: This study was a randomized, double-blind, placebo-controlled clinical trial. SETTING: Participants were women from 14 of 40 clinical centers of the Women's Health Initiative (WHI). PARTICIPANTS: Postmenopausal women (1416) aged 65 yr and older, free of probable dementia, and enrolled in WHI and the WHI Memory Study (WHIMS) trial of combination estrogen and progestin for a mean of 3 yr and followed for a mean of 1.35 yr, were studied. INTERVENTION: Intervention was conjugated equine estrogen (CEE; 0.625 mg) with 2.5 mg medroxyprogesterone acetate (MPA) in one daily tablet (CEE + MPA) or placebo. MAIN OUTCOME MEASURES: Annual rates of change in specific cognitive functions and affect, adjusted for time since randomization, were measured. RESULTS: CEE + MPA had a negative impact on verbal memory (P <or= 0.01) and a trend to a positive impact on figural memory (P = 0.012) over time compared with placebo, but other cognitive domains were not affected. Both effects on memory were evident only after long-term therapy. CEE + MPA did not significantly influence positive affect, negative affect, or depressive symptoms. CONCLUSIONS: The effect of CEE + MPA on cognitive function varies across cognitive domains in older women, reflecting both possible beneficial and detrimental actions of ovarian steroids on the aging brain. Our results extend prior findings about dementia and global cognitive function to age-related changes in specific cognitive functions and suggest directions for future research.

Affect↗

Calcium plus vitamin D supplementation and the risk of fractures.

BACKGROUND: The efficacy of calcium with vitamin D supplementation for preventing hip and other fractures in healthy postmenopausal women remains equivocal. METHODS: We recruited 36,282 postmenopausal women, 50 to 79 years of age, who were already enrolled in a Women's Health Initiative (WHI) clinical trial. We randomly assigned participants to receive 1000 mg of elemental [corrected] calcium as calcium carbonate with 400 IU of vitamin D3 daily or placebo. Fractures were ascertained for an average follow-up period of 7.0 years. Bone density was measured at three WHI centers. RESULTS: Hip bone density was 1.06 percent higher in the calcium plus vitamin D group than in the placebo group (P<0.01). Intention-to-treat analysis indicated that participants receiving calcium plus vitamin D supplementation had a hazard ratio of 0.88 for hip fracture (95 percent confidence interval, 0.72 to 1.08), 0.90 for clinical spine fracture (0.74 to 1.10), and 0.96 for total fractures (0.91 to 1.02). The risk of renal calculi increased with calcium plus vitamin D (hazard ratio, 1.17; 95 percent confidence interval, 1.02 to 1.34). Censoring data from women when they ceased to adhere to the study medication reduced the hazard ratio for hip fracture to 0.71 (95 percent confidence interval, 0.52 to 0.97). Effects did not vary significantly according to prerandomization serum vitamin D levels. CONCLUSIONS: Among healthy postmenopausal women, calcium with vitamin D supplementation resulted in a small but significant improvement in hip bone density, did not significantly reduce hip fracture, and increased the risk of kidney stones. (ClinicalTrials.gov number, NCT00000611.).

Aged↗

Calcium plus vitamin D supplementation and the risk of colorectal cancer.

BACKGROUND: Higher intake of calcium and vitamin D has been associated with a reduced risk of colorectal cancer in epidemiologic studies and polyp recurrence in polyp-prevention trials. However, randomized-trial evidence that calcium with vitamin D supplementation is beneficial in the primary prevention of colorectal cancer is lacking. METHODS: We conducted a randomized, double-blind, placebo-controlled trial involving 36,282 postmenopausal women from 40 Women's Health Initiative centers: 18,176 women received 500 mg of elemental calcium as calcium carbonate with 200 IU of vitamin D3 [corrected] twice daily (1000 mg of elemental calcium and 400 IU of vitamin D3) and 18,106 received a matching placebo for an average of 7.0 years. The incidence of pathologically confirmed colorectal cancer was the designated secondary outcome. Baseline levels of serum 25-hydroxyvitamin D were assessed in a nested case-control study. RESULTS: The incidence of invasive colorectal cancer did not differ significantly between women assigned to calcium plus vitamin D supplementation and those assigned to placebo (168 and 154 cases; hazard ratio, 1.08; 95 percent confidence interval, 0.86 to 1.34; P=0.51), and the tumor characteristics were similar in the two groups. The frequency of colorectal-cancer screening and abdominal symptoms was similar in the two groups. There were no significant treatment interactions with baseline characteristics. CONCLUSIONS: Daily supplementation of calcium with vitamin D for seven years had no effect on the incidence of colorectal cancer among postmenopausal women. The long latency associated with the development of colorectal cancer, along with the seven-year duration of the trial, may have contributed to this null finding. Ongoing follow-up will assess the longer-term effect of this intervention. (ClinicalTrials.gov number, NCT00000611.).

Adenocarcinoma↗

Low-fat dietary pattern and risk of invasive breast cancer: the Women's Health Initiative Randomized Controlled Dietary Modification Trial.

CONTEXT: The hypothesis that a low-fat dietary pattern can reduce breast cancer risk has existed for decades but has never been tested in a controlled intervention trial. OBJECTIVE: To assess the effects of undertaking a low-fat dietary pattern on breast cancer incidence. DESIGN AND SETTING: A randomized, controlled, primary prevention trial conducted at 40 US clinical centers from 1993 to 2005. PARTICIPANTS: A total of 48,835 postmenopausal women, aged 50 to 79 years, without prior breast cancer, including 18.6% of minority race/ethnicity, were enrolled. INTERVENTIONS: Women were randomly assigned to the dietary modification intervention group (40% [n = 19,541]) or the comparison group (60% [n = 29,294]). The intervention was designed to promote dietary change with the goals of reducing intake of total fat to 20% of energy and increasing consumption of vegetables and fruit to at least 5 servings daily and grains to at least 6 servings daily. Comparison group participants were not asked to make dietary changes. MAIN OUTCOME MEASURE: Invasive breast cancer incidence. RESULTS: Dietary fat intake was significantly lower in the dietary modification intervention group compared with the comparison group. The difference between groups in change from baseline for percentage of energy from fat varied from 10.7% at year 1 to 8.1% at year 6. Vegetable and fruit consumption was higher in the intervention group by at least 1 serving per day and a smaller, more transient difference was found for grain consumption. The number of women who developed invasive breast cancer (annualized incidence rate) over the 8.1-year average follow-up period was 655 (0.42%) in the intervention group and 1072 (0.45%) in the comparison group (hazard ratio, 0.91; 95% confidence interval, 0.83-1.01 for the comparison between the 2 groups). Secondary analyses suggest a lower hazard ratio among adherent women, provide greater evidence of risk reduction among women having a high-fat diet at baseline, and suggest a dietary effect that varies by hormone receptor characteristics of the tumor. CONCLUSIONS: Among postmenopausal women, a low-fat dietary pattern did not result in a statistically significant reduction in invasive breast cancer risk over an 8.1-year average follow-up period. However, the nonsignificant trends observed suggesting reduced risk associated with a low-fat dietary pattern indicate that longer, planned, nonintervention follow-up may yield a more definitive comparison. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT00000611.

Aged↗

Low-fat dietary pattern and risk of colorectal cancer: the Women's Health Initiative Randomized Controlled Dietary Modification Trial.

CONTEXT: Observational studies and polyp recurrence trials are not conclusive regarding the effects of a low-fat dietary pattern on risk of colorectal cancer, necessitating a primary prevention trial. OBJECTIVE: To evaluate the effects of a low-fat eating pattern on risk of colorectal cancer in postmenopausal women. DESIGN, SETTING, AND PARTICIPANTS: The Women's Health Initiative Dietary Modification Trial, a randomized controlled trial conducted in 48,835 postmenopausal women aged 50 to 79 years recruited between 1993 and 1998 from 40 clinical centers throughout the United States. INTERVENTIONS: Participants were randomly assigned to the dietary modification intervention (n = 19,541; 40%) or the comparison group (n = 29,294; 60%). The intensive behavioral modification program aimed to motivate and support reductions in dietary fat, to increase consumption of vegetables and fruits, and to increase grain servings by using group sessions, self-monitoring techniques, and other tailored and targeted strategies. Women in the comparison group continued their usual eating pattern. MAIN OUTCOME MEASURE: Invasive colorectal cancer incidence. RESULTS: A total of 480 incident cases of invasive colorectal cancer occurred during a mean follow-up of 8.1 (SD, 1.7) years. Intervention group participants significantly reduced their percentage of energy from fat by 10.7% more than did the comparison group at 1 year, and this difference between groups was mostly maintained (8.1% at year 6). Statistically significant increases in vegetable, fruit, and grain servings were also made. Despite these dietary changes, there was no evidence that the intervention reduced the risk of invasive colorectal cancer during the follow-up period. There were 201 women with invasive colorectal cancer (0.13% per year) in the intervention group and 279 (0.12% per year) in the comparison group (hazard ratio, 1.08; 95% confidence interval, 0.90-1.29). Secondary analyses suggested potential interactions with baseline aspirin use and combined estrogen-progestin use status (P = .01 for each). Colorectal examination rates, although not protocol defined, were comparable between the intervention and comparison groups. Similar results were seen in analyses adjusting for adherence to the intervention. CONCLUSION: In this study, a low-fat dietary pattern intervention did not reduce the risk of colorectal cancer in postmenopausal women during 8.1 years of follow-up. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT00000611.

Adenoma↗

Low-fat dietary pattern and risk of cardiovascular disease: the Women's Health Initiative Randomized Controlled Dietary Modification Trial.

CONTEXT: Multiple epidemiologic studies and some trials have linked diet with cardiovascular disease (CVD) prevention, but long-term intervention data are needed. OBJECTIVE: To test the hypothesis that a dietary intervention, intended to be low in fat and high in vegetables, fruits, and grains to reduce cancer, would reduce CVD risk. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial of 48,835 postmenopausal women aged 50 to 79 years, of diverse backgrounds and ethnicities, who participated in the Women's Health Initiative Dietary Modification Trial. Women were randomly assigned to an intervention (19,541 [40%]) or comparison group (29,294 [60%]) in a free-living setting. Study enrollment occurred between 1993 and 1998 in 40 US clinical centers; mean follow-up in this analysis was 8.1 years. INTERVENTION: Intensive behavior modification in group and individual sessions designed to reduce total fat intake to 20% of calories and increase intakes of vegetables/fruits to 5 servings/d and grains to at least 6 servings/d. The comparison group received diet-related education materials. MAIN OUTCOME MEASURES: Fatal and nonfatal coronary heart disease (CHD), fatal and nonfatal stroke, and CVD (composite of CHD and stroke). RESULTS: By year 6, mean fat intake decreased by 8.2% of energy intake in the intervention vs the comparison group, with small decreases in saturated (2.9%), monounsaturated (3.3%), and polyunsaturated (1.5%) fat; increases occurred in intakes of vegetables/fruits (1.1 servings/d) and grains (0.5 serving/d). Low-density lipoprotein cholesterol levels, diastolic blood pressure, and factor VIIc levels were significantly reduced by 3.55 mg/dL, 0.31 mm Hg, and 4.29%, respectively; levels of high-density lipoprotein cholesterol, triglycerides, glucose, and insulin did not significantly differ in the intervention vs comparison groups. The numbers who developed CHD, stroke, and CVD (annualized incidence rates) were 1000 (0.63%), 434 (0.28%), and 1357 (0.86%) in the intervention and 1549 (0.65%), 642 (0.27%), and 2088 (0.88%) in the comparison group. The diet had no significant effects on incidence of CHD (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.90-1.06), stroke (HR, 1.02; 95% CI, 0.90-1.15), or CVD (HR, 0.98; 95% CI, 0.92-1.05). Excluding participants with baseline CVD (3.4%), the HRs (95% CIs) for CHD and stroke were 0.94 (0.86-1.02) and 1.02 (0.90-1.17), respectively. Trends toward greater reductions in CHD risk were observed in those with lower intakes of saturated fat or trans fat or higher intakes of vegetables/fruits. CONCLUSIONS: Over a mean of 8.1 years, a dietary intervention that reduced total fat intake and increased intakes of vegetables, fruits, and grains did not significantly reduce the risk of CHD, stroke, or CVD in postmenopausal women and achieved only modest effects on CVD risk factors, suggesting that more focused diet and lifestyle interventions may be needed to improve risk factors and reduce CVD risk. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT00000611.

Aged↗

Elderly women diagnosed with nonspecific chest pain may be at increased cardiovascular risk.

BACKGROUND: Women are more likely than men to have nonspecific chest pain (NSCP) symptoms. The long-term outcomes in women discharged with a diagnosis of NSCP are unknown. METHODS: The Women's Health Initiative Observational Study enrolled postmenopausal women aged 50-79 years. After excluding those with prior cardiovascular disease (CVD), 83,622 women were studied. NSCP cases were defined as having an initial primary hospital discharge diagnosis of NSCP (ICD-9 codes 786.50, 786.51, 786.59) without a prior diagnosis of coronary heart disease (CHD). Risks of subsequent CHD events were estimated from Cox proportional hazard ratio (HR) models stratified by clinic and adjusted for baseline age, cardiovascular risk factors, and hormone use. RESULTS: Over an average of 8 years of follow-up, 11% (230 of 2,092) of women with NSCP experienced a cardiovascular event compared with 9.5% (7,724 of 81,530) who did not. Compared with women without a hospitalization for NSCP during follow-up, those with NSCP had a greater than 2-fold higher risk of a subsequent hospitalization for clinically diagnosed angina (HR 2.18, 95% CI 1.66-2.86) and at least a 1.5-fold higher risk of nonfatal myocardial infarction (MI) (HR 1.59, 1.10-2.31), revascularization (HR 1.67, 1.28-2.20), and congestive heart failure (HR 1.75, 1.27-2.41). Women with NSCP who subsequently experienced a CHD event were more likely to be over age 65 or to have cardiovascular risk factors. CONCLUSIONS: Older women discharged with a diagnosis of NSCP may be at increased risk of CHD morbidity. Further research is needed to replicate these findings in other populations.

Aged↗

Symptom experience after discontinuing use of estrogen plus progestin.

CONTEXT: Little is known about women's experiences after stopping menopausal hormone therapy. OBJECTIVE: To describe women's symptoms and management strategies after stopping the intervention in a large estrogen plus progestin trial. DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional survey of 8405 women (89.9%; N = 9351) at 40 clinical centers who were still taking study pills (conjugated equine estrogens plus medroxyprogesterone [CEE + MPA] or placebo) when the estrogen plus progestin intervention (Women's Health Initiative) was stopped. Surveys were mailed 8 to 12 months after the stop date. Logistic regression was used to model vasomotor symptoms and pain or stiffness symptoms as functions of former treatment and baseline symptoms, adjusted for appropriate covariates. MAIN OUTCOME MEASURES: Symptoms (vasomotor or pain and stiffness) and management strategies. RESULTS: Respondents' mean (SD) age at trial stop date was 69.1 (6.7) years. They averaged 5.7 years of taking study pills. Moderate or severe vasomotor symptoms after discontinuing study pill use were reported by 21.2% of former CEE + MPA and 4.8% of placebo group respondents overall and by 55.5% and 21.3%, respectively, with these symptoms at baseline (randomization). Compared with respondents in the former placebo group, moderate or severe vasomotor symptoms (adjusted odds ratio [AOR] 5.82; 95% confidence interval [CI], 4.92-6.89) and pain or stiffness symptoms (AOR, 2.16; 95% CI, 1.95-2.40) were more likely in respondents in the former CEE + MPA group. Both vasomotor symptoms (AOR, 5.36; 95% CI, 4.51-6.38) and pain or stiffness symptoms (AOR, 3.21; 95% CI, 2.90-3.56) also were more likely in women with these symptoms at baseline. Women reported a wide range of strategies to manage symptoms. CONCLUSIONS: More than half of the women with vasomotor symptoms at randomization to active CEE + MPA also reported these symptoms after discontinuing use of the study pills. However, these participants did not include women who were unwilling to be randomized or who had stopped taking the study pills earlier. These findings should be considered when advising women to treat menopausal symptoms with hormone therapy for as short duration as possible. Investigation of alternative strategies to manage menopausal symptoms is warranted.

Aged↗

The relationship between checklist scores on a communication OSCE and analogue patients' perceptions of communication.

Many efforts to teach and evaluate physician-patient communication are based on two assumptions: first, that communication can be conceptualized as consisting of specific observable behaviors, and second, that physicians who exhibit certain behaviors are more effective in communicating with patients. These assumptions are usually implicit, and are seldom tested. The purpose of this study was to investigate whether specific communication behaviors are positively related to patients' perceptions of effective communication. Trained raters used a checklist to record the presence or absence of specific communication behaviors in 100 encounters in a communication Objective Structured Clinical Examination (OSCE). Lay volunteers served as analogue patients and rated communication during each encounter. Correlations between checklist scores and analogue patients' ratings were not significantly different from zero for four of five OSCE cases studied. Within each case, certain communication behaviors did appear to be related to patients' ratings, but the critical behaviors were not consistent across cases. We conclude that scores from OSCE communication checklists may not predict patients' perceptions of communication. Determinants of patient perceptions of physician communication may be more subtle, more complex, and more case-specific than we were able to capture with the current checklist.

Aged↗

Predictors of smoking cessation in pregnancy and maintenance postpartum in low-income women.

OBJECTIVE: To describe factors associated with smoking status of low-income women during pregnancy and postpartum. METHODS: Data from a randomized clinical trial were used to conduct separate analyses on 327 women who smoked at baseline (time at enrollment) and for whom smoking status was available at delivery, and on 109 women who reported not smoking at delivery (quit spontaneously or after study enrollment) and for whom smoking status was available at 6-months postpartum. Salivary cotinine was used to assess the accuracy of self-reported smoking status for the sample as a whole. Data were collected between May 1997 and November 2000. RESULTS: 18% of the 327 baseline smokers stopped smoking before delivery. Cessation was less likely in older women, those reporting Medicaid coverage (vs. commercial or no insurance), who were at a later week of pregnancy at baseline, were more addicted, had a husband/partner who smoked, and did not receive the study intervention. 37% of the 109 women who reported not smoking at delivery maintained abstinence at 6-months postpartum. Factors associated with abstinence were later week of pregnancy at baseline and quitting spontaneously with pregnancy, while women who lived with a smoker were less likely to report abstinence. Spontaneous quitters were less likely to relapse by 6 months postpartum than women who quit smoking later in pregnancy. CONCLUSIONS: Partner participation in smoking cessation programs for pregnant and postpartum women merits exploration. Lower relapse rates among spontaneous quitters indicate a need to foster an environment that encourages quitting at pregnancy.

Adult↗

Organizational systems to support publicly funded tobacco treatment services.

BACKGROUND: Professional societies and government organizations have promoted guidelines and best practices that encourage clinicians to routinely integrate cessation counseling into patient encounters. While research in health maintenance organizations has demonstrated that the development and maintenance of office systems do enable clinicians' smoking-cessation services, little is known about the adoption of system strategies in diverse organizations serving disadvantaged populations. METHODS: Data were collected via face-to-face interviews from November 2001 to October 2002 using a standardized systems assessment checklist at service delivery sites of 83 funded community health service agencies, which included hospitals, community health centers, and other organizations (e.g., substance abuse, mental health, and multiservice). The content of the structured assessment reflected system elements with proven effectiveness that have been included in guidelines and best practices recommendations. Detailed information was collected on the implementation strategies. RESULTS: This study found considerable attention to systems that support cessation services in diverse healthcare organizations, but much remains to be done. There is a wide diversity of implementation strategies employed, with varied degrees of sophistication. CONCLUSIONS: A major challenge is to develop systems capable of providing population-based feedback to, and between, providers, which will enable further quality improvement efforts.

Adolescent↗

Brief physician and nurse practitioner-delivered counseling for high-risk drinking. Results at 12-month follow-up.

BACKGROUND: The objective of this study was to determine the effects of a brief primary care provider-delivered counseling intervention on the reduction of alcohol consumption by high-risk drinkers. The intervention was implemented as part of routine primary care medical practice. METHODS: We performed a controlled clinical trial with 6- and 12-month follow-up. Three primary care practices affiliated with an academic medical center were randomly assigned to special intervention (SI) or usual care (UC). A total of 9,772 primary care patients were screened for high-risk drinking. A fourth site was added later. From the group that was screened, 530 high-risk drinkers entered into the study, with 447 providing follow-up at 12 months. The intervention consisted of brief (5-10 minute) patient-centered counseling plus an office system that cued providers to intervene and provided patient educational materials. RESULTS: At 12-month follow-up, after controlling for baseline differences in alcohol consumption, SI participants had significantly larger changes (P=.03) in weekly alcohol intake compared to UC (SI=-5.7 drinks per week; UC=-3.1 drinks per week), and of those who changed to safe drinking at 6 months more SI participants maintained that change at 12 months than UC. CONCLUSIONS: Project Health provides evidence that screening and very brief (5-10 minute) advice and counseling delivered by a patient's personal physician or nurse practitioner as a routine part of a primary care visit can reduce alcohol consumption by high-risk drinkers.

Adult↗

Recollections and repercussions of the first inhaled cigarette.

CONTEXT: It has not been determined if a youth's reaction to the first smoking experience is predictive of future nicotine dependence, or whether the impact of the first cigarette can be altered by manipulating levels of tar, nicotine and menthol. OBJECTIVE: To determine if the recalled response to the first cigarette is predictive of the development of symptoms of nicotine dependence and whether it is influenced by the type of cigarette smoked. DESIGN AND SETTING: A retrospective/prospective longitudinal study of the natural history of nicotine dependence employing individual interviews conducted three times annually in two urban school systems over 3 years. Subjects were asked to recall their first smoking experience. PARTICIPANTS: A cohort of 237 subjects who had inhaled on a cigarette. MAIN OUTCOME MEASURES: Symptoms associated with smoking; the Hooked on Nicotine Checklist of 10 symptoms of dependence. RESULTS: Reactions to the initial smoking experience were unrelated to gender or cigarette brand, strength or mentholation. Relaxation in response to the first inhalation was the strongest predictor of symptoms of nicotine dependence. Dizziness and nausea were also independent predictors of dependence symptoms. CONCLUSIONS: The data suggest that increased sensitivity to nicotine as manifested by relaxation, dizziness, or nausea in response to the first exposure to nicotine represents a risk factor for the development of nicotine dependence.

Adolescent↗

Trait anxiety and nicotine dependence in adolescents: a report from the DANDY study.

The Revised Children's Manifest Anxiety Scale (RCMAS) and the Hooked on Nicotine Checklist (HONC) were used to measure trait anxiety and tobacco dependence in a population of 581 adolescents. Smokers demonstrated higher mean RCMAS scores (9.3, S.D.=6.5) than nonsmokers did (7.4, S.D.=6.2, t=-3.7, P<.001). Participants with symptoms of tobacco dependence had higher RCMAS scores (mean=11.6, S.D.=6.0, n=115) than did the participants without symptoms (mean=7.8, S.D.=6.0, n=177, t=-5.3, P<.001). Scores on the RCMAS and the HONC correlated positively (n=292, r=.32, P<.001). Participants who had felt relaxed in response to their first exposure to nicotine were also more likely to develop dependence and to report that stress caused cravings or a need to smoke. Trait anxiety and relaxation in response to the first dose of nicotine were unrelated and appear to be independent risk factors for the development of nicotine dependence and a reliance on tobacco to cope with stress.

Adolescent↗