Community-Engaged Survey Approach to Pandemic Impacts on Marginalized Communities, Massachusetts, 2020-2021.

Objectives. To describe how an innovative, community-engaged survey illuminated previously unmeasured pandemic inequities and informed health equity investments. Methods. The methodological approach of Massachusetts' COVID-19 Community Impact Survey, a cross-sectional online survey, was driven by key health equity principles: prioritizing community engagement, gathering granular and intersectional data, capturing root causes, elevating community voices, expediting analysis for timeliness, and creating data-to-action pathways. Data collection was deployed statewide in 11 languages from 2020 to 2021. Results. The embedded equity principles resulted in a rich data set and enabled analyses of populations previously undescribed. The final sample included 33 800 respondents including unprecedented numbers of populations underrepresented in traditional data sources. Analyses indicated that pandemic impacts related to basic needs, discrimination, health care access, workplace protections, employment, and mental health disproportionately affected these priority populations, which included Asian American/Pacific Islanders and parents. Conclusions. Equity-centered data approaches allow for analyses of populations previously invisible in surveillance data, enable more equitable public health action, and are both possible and necessary to deploy in state health departments. (Am J Public Health. 2024;114(S7):S599-S609. https://doi.org/10.2105/AJPH.2024.307800).

The Launch of Massachusetts Community Health Worker Certification: Findings From the Massachusetts Community Health Worker Workforce Surveys.

OBJECTIVES: The launch of state certification for community health workers (CHWs) in Massachusetts in 2018 aimed to promote and champion this critical workforce. However, concerns exist about unintentional adverse effects of certification. Given this, we conducted 2 cross-sectional surveys to evaluate this certification policy. METHODS: We conducted surveys of CHW employers and CHWs in 3 sample frames: community health centers and federally qualified health centers, acute-care hospitals, and community-based organizations. We administered the surveys in 2016 (before certification launch) and 2021 (after certification launch) to answer the following questions: Was certification associated with positive outcomes among CHWs after its launch? Did harmful shifts occur among the CHW workforce and employers after certification launch? Was certification associated with disparities among CHWs after its launch? RESULTS: Certification was associated with higher pay among certified (vs noncertified) CHWs, better perceptions of CHWs among certified (vs noncertified) CHWs, and better integration of certified (vs noncertified) CHWs into care teams. We found no adverse shifts in CHW workforce by sociodemographic variables or in CHW employer characteristics (most notably CHW employer hiring requirements) after certification launch. After certification launch, certified and uncertified CHWs had similar demographic and educational characteristics. However, certified CHWs more often worked in large, clinical organizations while uncertified CHWs most often worked in medium-sized community-based organizations. CONCLUSIONS: Our evaluation of Massachusetts CHW certification suggests that CHW certification was not associated with workforce disparities and was associated with positive outcomes. Our study fills a notable gap in the research literature and can guide CHW research agendas, certification efforts in Massachusetts and other states, and program efforts to champion this critical, grassroots workforce.

Additive impact of multiple point-of-sale tobacco control policies on youth tobacco-related outcomes.

Objectives: The tobacco industry utilizes tactics to increase youth awareness, exposure, access and use of tobacco. To address these tactics, municipalities in Massachusetts have passed point-of-sale policies including: 1) restricting flavored tobacco (FTR), 2) restricting cigar package sizes and prices (CPPR), 3) banning tobacco in pharmacies (PB), and 4) raising the minimum legal sales age of tobacco to 21 (MLSA 21). This study evaluated whether more policies, and a combination of policies addressing all three industry tactics, are associated with more favorable youth tobacco-related outcomes. Study design: This study was a cross-sectional survey. Methods: Municipalities were selected based on number of policies and similarity of municipality and tobacco retailer characteristics. The final sample included: Somerville with all four policies, Worcester with two policies (MLSA 21 and PB), and New Bedford with one policy (PB). Surveys were administered to youth in a public high school in each municipality. Multivariable models were used to compare tobacco-related outcomes between municipalities with varying numbers of policies. Results: After adjusting for individual-level demographics, we observed a protective effect of having more policies on flavored tobacco initiation and tobacco exposure and awareness. A protective effect of number of policies on tobacco use was not found, but associations were primarily in the expected direction. Current tobacco users in Somerville had higher odds of menthol use compared to New Bedford. Conclusions: Implementing multiple policies addressing varied industry tactics may be effective for youth tobacco prevention. Including menthol in FTRs may help improve youth tobacco-related outcomes.

Evaluating the impact of community health worker certification in Massachusetts: Design, methods, and anticipated results of the Massachusetts community health worker workforce survey.

Background: Professional certification of community health workers (CHWs) is a debated topic. Although intended to promote CHWs, certification may have unintended impacts given the grassroots nature of the workforce. As such, both intended effects and unintended adverse effects should be carefully evaluated. However, there is a lack of published literature describing such effective evaluations with a robust methodology. In this methods paper, we describe a key component of evaluating CHW certification in Massachusetts-the Massachusetts CHW Workforce Survey. Methods: Design of the surveys was informed by a program theory framework that delineated both positive and negative potential impacts of Massachusetts CHW certification on CHWs and CHW employers. Using this framework, we developed measures of interest and preliminary CHW and CHW employer surveys. To validate and refine the surveys, we conducted cognitive interviews with CHWs and CHW employers. We then finalized survey tools with input from state and national stakeholders, CHWs, and CHW employers. Our sample consisted of three frames based on where CHWs are most likely to be employed in Massachusetts: acute care hospitals, community-based organizations, and ambulatory care health centers, primarily community health centers and federally qualified health centers. We then undertook extensive outreach efforts to determine whether each organization employed CHWs and to obtain CHW and CHW employer contact information. Our statistical analysis of the data utilized inverse probability score weighting accounting for organizational, site, and individual response. Anticipated results: Wave one of the survey was administered in 2016 prior to launch of Massachusetts CHW certification and wave two in 2021. We report descriptive statistics of the three sample frames and response rates of each survey for each wave. Further, we describe select anticipated results related to certification, including outcomes of the program theory framework. Conclusions: The Massachusetts CHW Workforce Survey is the culmination of 5 years of effort to evaluate the impact of CHW certification in Massachusetts. Our comprehensive description of our methodology addresses an important gap in CHW research literature. The rigorous design, administration, and analysis of our surveys ensure our findings are robust, valid, and replicable, which can be leveraged by others evaluating the CHW workforce.

Longer-Term Impact of the Flavored Tobacco Restriction in Two Massachusetts Communities: A Mixed-Methods Study.

INTRODUCTION: In response to high rates of youth tobacco use, many states and localities are considering regulations on flavored tobacco products. The purpose of this study was to assess whether flavored tobacco restrictions (FTRs) in Massachusetts curb youth tobacco use over time and whether a dose-response effect of length of policy implementation on tobacco-related outcomes exists. AIMS AND METHODS: Using a quasiexperimental design, two municipalities with a FTR (adopting municipalities) were matched to a comparison municipality without a FTR. Surveys were administered before (December 2015) and after (January and February 2018) policy implementation to high school students in these municipalities (more than 2000 surveys completed at both timepoints). At follow-up, adopting municipalities had a policy in place for 1 and 2 years, respectively. In 2019, focus groups were conducted with high school students in each municipality. RESULTS: Increases seen in current tobacco use from baseline to follow-up were significantly smaller in adopting municipalities compared to the comparison (-9.4% [-14.2%, -4.6%] and -6.3% [-10.8%, -1.8%], respectively). However, policy impact was greater in one adopting municipality despite shorter length of implementation. Focus groups indicated reasons for differential impact, including proximity to localities without FTRs. CONCLUSIONS: Restrictions implemented in adopting municipalities had positive impacts on youth tobacco awareness and use 1-2 years postimplementation. Policy impact varies depending on remaining points of access to flavored tobacco, as such policy effectiveness may increase as more localities restrict these products. IMPLICATIONS: In response to high rates of youth flavored tobacco use (including flavored vape products), federal, state, and localities have passed FTRs that reduce availability of flavored tobacco in youth-accessible stores. Previous research has found that FTRs may curb youth tobacco use in the short-term; however, the long-term effectiveness remains unknown.This is the first study to show FTRs can curb youth tobacco use and reduce youth awareness of tobacco prices and brands even 2 years after policy passage. Municipality-specific factors, including proximity to localities without FTRs, may attenuate policy impact, highlighting the importance of widespread policy adoption.

Impact of flavoured tobacco restriction policies on flavoured product availability in Massachusetts.

OBJECTIVE: This study aimed to evaluate the effectiveness of flavoured tobacco product restriction policies in reducing availability of flavoured products in Massachusetts communities. METHODS: Data were obtained from surveys of tobacco retailers conducted from July 2015 to March 2017. On a community level, flavoured product availability was defined as the per cent of retailers during a given 3-month quarter that sold flavoured cigars/cigarillos, electronic cigarettes and/or e-liquids. Communities that implemented the policy during the study period were grouped into wave 1 (n=18; 1481 retail surveys) and wave 2 (n=20; 483 retail surveys) by date of policy implementation; communities without a flavoured product restriction served as the control group (n=234; 4932 retail surveys). A difference-in-difference analysis was used to compare the change in flavoured product availability in wave 1 and wave 2 communities 3 months pre-policy and post-policy implementation to the change over the same time periods in the control group. RESULTS: From pre-policy to post-policy implementation period, communities in both waves experienced significant reductions in flavoured product availability (ranging from 27.2% to 50.9%), even after adjusting for community-level characteristics. In both waves 1 and 2, reductions in flavoured product availability were significantly greater compared with comparison communities during the same time frame, adjusting for community-level characteristics. CONCLUSIONS: Compliance with flavoured product restriction policies is high among tobacco retailers throughout Massachusetts, regardless of community demographic and retail characteristics. Reduced availability of flavoured tobacco in the retail environment has the potential to reduce youth exposure, access and use of these products.

Short-Term Impact of a Flavored Tobacco Restriction: Changes in Youth Tobacco Use in a Massachusetts Community.

INTRODUCTION: To counter the high prevalence of flavored tobacco use among youth, many U.S. localities have passed policies that restrict youth access to these products. This study aims to evaluate the short-term impact of a flavored tobacco restriction policy on youth access to, and use of, flavored tobacco products in a Massachusetts community. METHODS: A community with the policy (Lowell) was matched to a community without the policy (Malden) with similar demographics, retailer characteristics, and point-of-sale tobacco policies. Product inventories were assessed in tobacco retailers in the 2 communities, and surveys were administered to high school-aged youth in those communities. Inventories and surveys were conducted around the time the policy took effect in October 2016 (baseline) and approximately 6 months later (follow-up); all data were analyzed in 2017. Chi-squared tests and difference-in-difference models were used to estimate the impact of the policy on flavored tobacco availability and youth perceptions and behaviors related to flavored tobacco use. RESULTS: Flavored tobacco availability decreased significantly in Lowell from baseline to follow-up periods by 70 percentage points (p<0.001), whereas no significant changes in flavored tobacco availability were seen in Malden. In addition, current use of both flavored and non-flavored tobacco decreased in Lowell, but increased in Malden from baseline to follow-up; these changes were significantly different between communities (flavored tobacco: -5.7%, p=0.03; non-flavored tobacco: -6.2%, p=0.01). CONCLUSIONS: Policies that restrict the sale of flavored tobacco have the potential to curb youth tobacco use in as few as 6 months.

Single Cigar Price and Availability in Communities With and Without a Cigar Packaging and Pricing Regulation.

Single cigars are available for sale throughout the tobacco retail environment, are often sold for prices as low as 49 cents, and are available in flavors that appeal to youth. Since 2012, 151 municipalities in Massachusetts have enacted a minimum cigar packaging and pricing regulation that increases the price of a single cigar to a minimum of $2.50 and the price of multi-packs of 2 cigars to a minimum of $5.00. We used pricing data collected from retailers across the state to measure the effect of the regulation on price and availability of single cigars over the long term. From 2014 through 2018, the statewide average price of single cigars increased from $1.35 to $1.64, concurrent with a decrease in statewide availability. Prices of single cigars were higher in communities with the regulation but also rose over time in communities without the regulation. The increased price and decreased availability of single cigars may reduce youth exposure and access to these products.

The association between neighborhood racial composition and menthol cigarette pricing in Boston, MA.

OBJECTIVES: To examine the relationship between neighborhood demographics and pack prices of four brands of mentholated and non-mentholated cigarettes in Boston, Massachusetts. METHODS: Using tobacco pricing survey data collected July 2015 to June 2016, we examined cigarette prices in tobacco retailers (n = 689) located in block groups (n = 325) of Boston. Multilevel models examined both the association of menthol and non-menthol cigarette prices, and the percentage of retailers selling cigarettes below established minimum price in relation to neighborhood demographics. RESULTS: Each 10 percentage point increase in the proportion of black residents per block group was associated with a price decrease of 3 cents for menthol cigarettes (p < 0.01). Each 10 percentage point increase in the proportion of black residents per block group was associated with a 19 percentage point increase in proportion of retailers selling menthol cigarettes ≥25 cents below minimum price (p < 0.01). CONCLUSION: Mentholated cigarettes were priced significantly lower in neighborhoods of color in Boston. Strengthened pricing laws, with consideration given to menthol products in the retail environment, may be needed to address environmental contributors to smoking disparities.

Evaluation of the Environmental Scoring System in Multiple Child Asthma Intervention Programs in Boston, Massachusetts.

OBJECTIVES: To test the applicability of the Environmental Scoring System, a quick and simple approach for quantitatively measuring environmental triggers collected during home visits, and to evaluate its contribution to improving asthma outcomes among various child asthma programs. METHODS: We pooled and analyzed data from multiple child asthma programs in the Greater Boston Area, Massachusetts, collected in 2011 to 2016, to examine the association of environmental scores (ES) with measures of asthma outcomes and compare the results across programs. RESULTS: Our analysis showed that demographics were important contributors to variability in asthma outcomes and total ES, and largely explained the differences among programs at baseline. Among all programs in general, we found that asthma outcomes were significantly improved and total ES significantly reduced over visits, with the total Asthma Control Test score negatively associated with total ES. CONCLUSIONS: Our study demonstrated that the Environmental Scoring System is a useful tool for measuring home asthma triggers and can be applied regardless of program and survey designs, and that demographics of the target population may influence the improvement in asthma outcomes.

Concordance Between Common Hypertension Control Algorithms in Electronic Medical Record Data.

Because quality improvement metrics and treatment guidelines are used to conduct research, evaluate care quality, and assess population health, they should, ideally, align. We used electronic medical record data to analyze variation between blood pressure control estimates calculated by using thresholds derived from National Quality Forum 0018 (NQF 0018) and Joint National Committee (JNC) treatment guidelines in a cohort of patients with hypertension. Percentage of patients with controlled blood pressure derived from each quality improvement or treatment guideline cutoff varied up to 16.1 percentage points. This variance demonstrates that discrepancies in blood pressure thresholds produce considerable variation in estimates; thus, treatment guidance and metrics should be selected carefully.

The development and expression of physical nicotine dependence corresponds to structural and functional alterations in the anterior cingulate-precuneus pathway.

INTRODUCTION: Perturbations in neural function provoked by a drug are thought to induce neural adaptations, which, in the absence of the drug, give rise to withdrawal symptoms. Previously published structural data from this study indicated that the progressive development of physical dependence is associated with increasing density of white matter tracts between the anterior cingulum bundle and the precuneus. METHODS: Using functional magnetic resonance imaging, we compared 11 smokers after 11 h of abstinence from nicotine and after satiation, with 10 nonsmoking controls, using independent component analysis for brain network comparisons as well as a whole brain resting-state functional connectivity analysis using the anterior cingulate cortex as a seed. RESULTS: Independent component analysis demonstrated increased functional connectivity in brain networks such as the default mode network associated with the withdrawal state in multiple brain regions. In seed-based analysis, smokers in the withdrawal state showed stronger functional connectivity than nonsmoking controls between the anterior cingulate cortex and the precuneus, caudate, putamen, and frontal cortex (P < 0.05). Among smokers, compared to the satiated state, nicotine withdrawal was associated with increased connectivity between the anterior cingulate cortex and the precuneus, insula, orbital frontal gyrus, superior frontal gyrus, posterior cingulate cortex, superior temporal, and inferior temporal lobe (P < 0.02). The intensity of withdrawal-induced craving correlated with the strength of connectivity between the anterior cingulate cortex and the precuneus, insula, caudate, putamen, middle cingulate gyrus, and precentral gyrus (r = 0.60-0.76; P < 0.05). CONCLUSIONS: In concordance with our previous report that structural neural connectivity between the anterior cingulate area and the precuneus increased in proportion to the progression of physical dependence, resting-state functional connectivity in this pathway increases during nicotine withdrawal in correlation with the intensity of withdrawal-induced craving. These findings suggest that smoking triggers structural and functional neural adaptations in the brain that support withdrawal-induced craving.

What aspect of dependence does the fagerström test for nicotine dependence measure?

Although the Fagerström Test for Nicotine Dependence (FTND) and the Heaviness of Smoking Index (HSI) are widely used, there is a uncertainty regarding what is measured by these scales. We examined associations between these instruments and items assessing different aspects of dependence. Adult current smokers (n = 422, mean age 33.3 years, 61.9% female) completed a web-based survey comprised of items related to demographics and smoking behavior plus (1) the FTND and HSI; (2) the Autonomy over Tobacco Scale (AUTOS) with subscales measuring Withdrawal, Psychological Dependence, and Cue-Induced Cravings; (3) 6 questions tapping smokers' wanting, craving, or needing experiences in response to withdrawal and the latency to each experience during abstinence; (4) 3 items concerning how smokers prepare to cope with periods of abstinence. In regression analyses the Withdrawal subscale of the AUTOS was the strongest predictor of FTND and HSI scores, followed by taking precautions not to run out of cigarettes or smoking extra to prepare for abstinence. The FTND and its six items, including the HSI, consistently showed the strongest correlations with withdrawal, suggesting that the behaviors described by the items of the FTND are primarily indicative of a difficulty maintaining abstinence because of withdrawal symptoms.

The assessment of tobacco dependence in young users of smokeless tobacco.

INTRODUCTION: As all published measures of dependence for users of smokeless tobacco (dippers) have poor reliability, in the present work the Hooked on Nicotine Checklist (HONC) and the Autonomy Over Smoking Scale (AUTOS) were evaluated for use with this population. Dippers and smokers were also compared in relation to dependence, the pleasure derived from using tobacco and the latency to the onset of withdrawal. METHODS: In 2010, an anonymous self-completed paper survey was administered to 1541 students of mixed race and ethnicity in grades 9-12 (mean age 15.9 years) in a Florida high school where students used cigarettes and smokeless tobacco. RESULTS: The reliability (Cronbach's α) for the HONC was 0.90 for smokers (n = 139) and 0.91 for dippers (n = 85), and for the AUTOS was 0.94 for smokers and dippers. Dippers and smokers did not differ significantly in relation to scores on the HONC, AUTOS, latency to withdrawal onset or pleasure derived from smoking. One or more symptoms on the HONC were reported by 56% of dippers and 57% of smokers with <100 lifetime uses of their favoured tobacco product, and by 91% of dippers and 91% of smokers with ≥ 100 lifetime uses (not significant). Greater lifetime use was associated with a significantly shorter latency to withdrawal for smokers and dippers. CONCLUSIONS: The HONC and AUTOS are highly reliable measures of dependence for adolescent users of cigarettes and smokeless tobacco. Using these measures and other indicators, no meaningful differences in dependence were found between dippers and smokers at comparable levels of lifetime use.

The developmental sequence of tobacco withdrawal symptoms of wanting, craving and needing.

OBJECTIVE: The first case series on tobacco addiction suggested that withdrawal symptoms evolve through a clear developmental sequence both over the clinical course and during an episode of abstinence. The objective of the current study was to determine if this observation would be confirmed by a second case series. METHODS: The subjects were 25 adolescent and adult smokers. Subjects were provided with operational definitions of the withdrawal symptoms of wanting, craving and needing. Using nondirective techniques, detailed histories of subjects' experiences with these three symptoms during abstinence from tobacco were obtained in individual interviews. RESULTS: All 25 subjects identified the operational definitions of wanting and craving as symptoms they had experienced, and 21 subjects indicated that the definition of needing described a symptom they had experienced. All 25 subjects reported that wanting was the first symptom they had experienced; 24 of 25 subjects reported that craving was the second symptom experienced; and 20 of the 21 subjects that had experienced needing reported that this was the third symptom they had experienced. All subjects reported that during abstinence symptoms appeared in the order of wanting, craving and needing. Subjects reported that stress-induced urges to smoke are not relieved by smoking, do not follow a characteristic sequence, and do not have a latency. CONCLUSIONS: Abstinence from tobacco provokes characteristic symptoms of wanting, craving and needing that are widely endorsed by smokers as symptoms they have experienced. These symptoms develop in a set sequence of wanting, craving and needing in all, or nearly all, smokers over their clinical course. These symptoms recur in the same sequence during acute episodes of abstinence. Smokers can distinguish between four symptoms: wanting, craving, needing and stress-induced urges to smoke, but these distinctions are not captured by generic 'craving' measures.

An evaluation of a clinical approach to staging tobacco addiction.

OBJECTIVES: To determine whether adolescents' symptom reports are consistent with the developmental sequence of tobacco addiction and whether the sequential appearance of these symptoms signifies increasing addiction. STUDY DESIGN: An anonymous survey was administered to 349 tobacco users in grades 9 through 12 in Florida. The combinations of withdrawal symptoms reported were examined to determine whether they were consistent with the developmental sequence described by case reports (wanting, then craving, then needing). Dependence was measured by several validated measures, including the Hooked on Nicotine Checklist, the Autonomy Over Tobacco Scale, and the modified Fagerström Tolerance Questionnaire. RESULTS: The combinations of withdrawal symptoms reported by 99.4% of subjects were consistent with case reports stating that wanting, craving, and needing develop in that sequence. Across the stages, from wanting to needing, higher stages were associated with significant increases in the strength of addiction as measured by the Hooked on Nicotine Checklist, the Autonomy Over Tobacco Scale, the modified Fagerström Tolerance Questionnaire, and all other measures. CONCLUSIONS: Our data confirmed that withdrawal symptoms develop in an orderly sequence, as proposed, and indicate that each progressive step along the sequence of wanting, craving, and needing represents a substantial increase in tobacco addiction. This provides the foundation for a clinical approach to staging the progression of tobacco addiction.

Development of a measure of the latency to needing a cigarette.

PURPOSE: People addicted to smoking experience a recurrent physiologic need to smoke anytime when they go too long without smoking. Our purpose was to evaluate the reliability and concurrent validity of a measure of the time elapsed between completion of smoking one cigarette and experiencing the need to smoke another (the latency to needing a cigarette-LTNC). We also investigated the relationship between the LTNC and dependence-related symptoms. METHODS: An anonymous, self-administered survey was completed by 134 current adolescent smokers, and in a separate study, 32 smokers were asked to complete a retest. RESULTS: A frequent need to smoke was reported by 84.3% of the current smokers. Consistent with published case histories, the duration of the LTNC varied widely between the individuals. Among subjects who reported a regular need to smoke, 48% reported that their LTNC had shortened over time. The median LTNC among subjects who had smoked <100 cigarettes was 243 hours as compared with 2 hours for those who had smoked ≥ 100 cigarettes (p < .001). Test-retest reliability was reported to be excellent (r = .85, p < .001). As expected, LTNC correlated moderately and inversely with daily cigarette consumption (ρ = -.53, p < .001). It also correlated inversely with cue-induced craving (ρ = -.64, p < .001), psychological reliance on cigarettes (ρ = -.43, p < .001), nicotine withdrawal (ρ = -.57, p < .001), and pleasure obtained from smoking (ρ = -.39, p < .001). CONCLUSION: The data obtained in this study support the reliability and concurrent validity of the LTNC measure.

A systematic review of the International Classification of Diseases criteria for the diagnosis of tobacco dependence.

Our objective was to examine the evidence concerning the validity and reliability of the International Classification of Diseases criteria for tobacco dependence (ICD-TD). A literature search was conducted of 16 databases using the search terms addiction, cigarettes, Diagnostic and Statistical Manual of Disease, DSM, dependence, International Classification of Diseases, ICD, nicotine, smoking and tobacco. The search produced 37 relevant articles. We found no data supporting the predictive validity of the criteria, and none supporting the characterization of dependence as having a three-symptom threshold. We found no data concerning the validity or reliability of the official instrument, which inappropriately excludes nondaily smokers from being evaluated for dependence. We found no evidence that the ICD-TD diagnosis had been used for clinical decision making, in a smoking cessation study, or for longitudinal epidemiological surveillance. We contrast the utility of the ICD-TD criteria to an approach of diagnosing tobacco addiction on the basis of a single criterion of a compulsion to use tobacco.

A systematic review of the Diagnostic and Statistical Manual diagnostic criteria for nicotine dependence.

The Diagnostic and Statistical Manual diagnostic criteria for nicotine dependence (DSM-ND) are based on the proposition that dependence is a syndrome that can be diagnosed only when a minimum of 3 of the 7 proscribed features are present. The DSM-ND criteria are an accepted research measure, but the validity of these criteria has not been subjected to a systematic evaluation. To systematically review evidence of validity and reliability for the DSM-ND criteria, a literature search was conducted of 16 national and international databases. Each article with original data was independently reviewed by two or more reviewers. In total, 380 potentially relevant articles were examined and 169 were reviewed in depth. The DSM-ND criteria have seen wide use in research settings, but sensitivity and specificity are well below the accepted standards for clinical applications. Predictive validity is generally poor. The 7 DSM-ND criteria are regarded as having face validity, but no data support a 3-symptom ND diagnostic threshold, or a 4-symptom withdrawal syndrome threshold. The DSM incorrectly states that daily smoking is a prerequisite for withdrawal symptoms. The DSM shows poor to modest concurrence with all other measures of nicotine dependence, smoking behaviors and biological measures of tobacco use. The data support the DSM-ND criteria as a valid measure of nicotine dependence severity for research applications. However, the data do not support the central premise of a 3-symptom diagnostic threshold, and no data establish that the DSM-ND criteria provide an accurate diagnosis of nicotine dependence.