Evaluation of a Statewide Flavored Tobacco Restriction on Use, Access, and Cessation Among Black and White Tobacco Users in Massachusetts.

PURPOSE: To evaluate the impact of a statewide flavored tobacco restriction among Massachusetts residents who use menthol or flavored tobacco and to assess differences in impact between Black and White users, as the tobacco industry has targeted menthol to Black users. DESIGN: An online survey was distributed through a panel provider and household mailings. SETTING: Eleven Massachusetts communities with higher-than-state-average Black, Indigenous or People of Color populations. SUBJECTS: Black (n = 63) and White (n = 231) non-Hispanic residents who used menthol or other flavored tobacco products in the past year. MEASURES: Impact of the law on use, access, and quitting behaviors. ANALYSIS: Outcomes were assessed between Blacks and Whites using Pearson chi-square tests. RESULTS: Over half (53% of White, 57% of Black) of respondents believed the law made it more difficult to access menthol products; two-thirds (67% of White,64% of Black) accessed menthol products in another state. Black users were significantly more likely to report purchasing menthol products off the street (P ≤ .05). One-third (28% of White, 32% of Black) believed the law made it easier to quit, and one-third (27% of White, 34% of Black) completely quit in the past year. CONCLUSIONS: Flavored tobacco restrictions may positively and equitably impact cessation. Cross-border access and off-the-street purchasing suggest the need for greater cessation support and underscore the importance of a national policy.

Smoke-Free Policies and Resident Turnover: An Evaluation in Massachusetts Public Housing From 2009‒2018.

INTRODUCTION: Smoke-free policies (SFP) in multi-unit housing are a promising tool for reducing exposure to tobacco smoke among residents. Concerns about increased housing instability due to voluntary or involuntary transitions induced by SFPs have been a primary barrier to greater widespread adoption. The impact of SFP implementation on transitions out of public housing in federally funded public housing authorities in Massachusetts was evaluated. METHODS: Tenancy data from the Department of Housing and Urban Development were used to determine the time from admission to transitioning out of public housing based on a cohort study design. Periods of exposure to SFPs were defined based on dates of SFP implementation at each PHA. Multi-level Cox regression models were fit to estimate the effects of SFPs on the hazard of transitioning, adjusting for household- and PHA-level characteristics. Analyses were conducted in 2021‒2022. RESULTS: There were 44,705 households with a record of residence in Massachusetts PHAs over 2009‒2018. Over this period, despite increasing adoption of SFPs among the PHAs, rates of transition remained steady at around 5‒8 transitions per 1,000 household-months. There was no overall association between exposure to SFPs and transitions among the full sample (adjusted HR=0.99, 95% CI=0.95, 1.04, p=0.794). However, the association varied significantly by age group, race/ethnicity, timing of SFP adoption, and era of admission. CONCLUSIONS: Adoption of SFPs in public housing had a minimal overall impact on turnover for households in Massachusetts, though disparities in the impact were observed between different demographic and PHA-level subgroups.

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.

Impact of Massachusetts' Statewide Sales Restriction on Flavored and Menthol Tobacco Products on Tobacco Sales in Massachusetts and Surrounding States, June 2020.

In June 2020, Massachusetts implemented a first in the nation statewide law that restricts sales of menthol and other flavored tobacco. Since implementation, sales data indicate high retailer compliance. Drastic decreases were seen in sales of all flavored tobacco. Most neighboring states did not see increases in overall tobacco sales, although New Hampshire saw an initial increase in menthol sales, which was not sustained. We found that menthol restrictions are effective and that federal-level legislation is important, as some cross-border sales highlight. (Am J Public Health. 2022;112(8):1147-1150. https://doi.org/10.2105/AJPH.2022.306879).

Implementation Activities in Smoke-Free Public Housing: The Massachusetts Experience.

A 2018 rule requiring federally-subsidized public housing authorities (PHAs) in the United States to adopt smoke-free policies (SFPs) has sparked interest in how housing agencies can best implement SFPs. However, to date, there is little quantitative data on the implementation of SFPs in public housing. Massachusetts PHAs were among the pioneers of SFPs in public housing, and many had instituted SFPs voluntarily prior to the federal rule. The aim of this study was to examine the adoption, implementation, and outcomes of SFPs instituted in Massachusetts PHAs prior to 2018 using a survey conducted that year. The survey asked if PHAs had SFPs and, if so, what activities were used to implement them: providing information sessions, offering treatment or referral for smoking cessation, soliciting resident input, training staff, partnering with outside groups, using a toolkit, and/or providing outdoor smoking areas. We used multivariable regression to investigate associations between implementation activities and respondent-reported policy outcomes (resident support, complaints about neighbors' smoking, and the number of violations reported per year). Of 238 Massachusetts PHAs, 218 (91%) completed the survey and 161 had an SFP prior to 2018. Common implementation activities were offering smoking cessation treatment/referral (89%) and information sessions for residents (85%). Information sessions for residents were associated with higher resident support (adjusted odds ratio [AOR] 4.3; 95%CI 1.2-15.3). Training staff (AOR 6.3, 95%CI 1.2-31.8) and engaging in ≥5 implementation activities (AOR 4.1, 95%CI 1.2-14.1) were associated with fewer smoking-related complaints. Utilization of multiple implementation activities, especially ones that informed residents and trained PHA staff, was associated with more favorable policy outcomes. We identified five groups of PHAs that shared distinct patterns of SFP implementation activities. Our findings, documenting implementation activities and their associations with SFP outcomes among the early adopters of SPFs in Massachusetts public housing, can help inform best practices for the future implementation of SFPs in multiunit housing.

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.

Evaluating tobacco retailer experience and compliance with a flavoured tobacco product restriction in Boston, Massachusetts: impact on product availability, advertisement and consumer demand.

BACKGROUND: Flavoured tobacco products are widely available in youth-accessible retailers and are associated with increased youth initiation and use. The city of Boston, Massachusetts restricted the sale of flavoured tobacco products, including cigars, smokeless tobacco and e-cigarettes, to adult-only retailers. This paper describes the impact of the restriction on product availability, advertisement and consumer demand. METHODS: Between January and December 2016, data were collected in 488 retailers in Boston at baseline and 469 retailers at 8-month follow-up, measuring the type, brand and flavour of tobacco products being sold. Process measures detailing the educational enforcement process, and retailer experience were also captured. McNemar tests and t-tests were used to assess the impact of the restriction on product availability. RESULTS: After policy implementation, only 14.4% of youth-accessible retailers sold flavoured products compared with 100% of retailers at baseline (p<0.001). Flavoured tobacco product advertisements decreased from being present at 58.9% of retailers to 28.0% at follow-up (p<0.001). Postimplementation, retailers sold fewer total flavoured products, with remaining products often considered as concept flavours (eg, jazz, blue). At follow-up, 64.0% of retailers reported that customers only asked for flavoured products a few times a week or did not ask at all. Retailers reported that educational visits and the flavoured product guidance list aided with compliance. CONCLUSION: Tobacco retailers across Boston were largely in compliance with the regulation. Availability of flavoured tobacco products in youth-accessible retailers declined city-wide after policy implementation. Strong educational and enforcement infrastructure may greatly enhance retailer compliance.

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.

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.

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.

Development of the Good Health Research Practice course: ensuring quality across all health research in humans.

Quality and ethics need to be embedded into all areas of research with human participants. Good Clinical Practice (GCP) guidelines are international ethical and scientific quality standards for designing, conducting, recording and reporting trials involving human participants. Compliance with GCP is expected to provide public assurance that the rights, safety and wellbeing of participants are protected and that the clinical research data are credible. However, whilst GCP guidelines, particularly their principles, are recommended across all research types, it is difficult for non-clinical trial research to fit in with the exacting requirements of GCP. There is therefore a need for guidance that allows health researchers to adhere to the principles of GCP, which will improve the quality and ethical conduct of all research involving human participants. These concerns have led to the development of the Good Health Research Practice (GHRP) course. Its goal is to ensure that research is conducted to the highest possible standards, similar to the conduct of trials to GCP. The GHRP course provides training and guidance to ensure quality and ethical conduct across all health-related research. The GHRP course has been run so far on eight occasions. Feedback from delegates has been overwhelmingly positive, with most delegates stating that the course was useful in developing their research protocols and documents. Whilst most training in research starts with a guideline, GHRP has started with a course and the experience gained over running the courses will be used to write a standardised guideline for the conduct of health-related research outside the realm of clinical trials, so that researchers, funders and ethics committees do not try to fit non-trials into clinical trials standards.

Monitoring clinical trials: a practical guide.

This article describes the processes and procedures involved in planning, conducting and reporting monitoring activities for large Clinical Trials of Investigational Medicinal Products (CTIMPs), focusing on those conducted in resource-limited settings.

Promoting good health research practice in low- and middle-income countries.

BACKGROUND: Good clinical practice (GCP) guidelines have been the source of improvement in the quality of clinical trials; however, there are limitations to the application of GCP in the conduct of health research beyond industry-sponsored clinical trials. The UNICEF/UNDP/World Bank/WHO Special Program for Research and Training in Tropical Disease is promoting good practice in all health research involving human through the Good Health Research Practice (GHRP) training program initiative. OBJECTIVE: To report the results of piloting the GHRP training program and formulate further steps to harness GHRP for promoting good practices in all health research involving human, particularly in low- and middle-income countries (LMICs). DESIGN: The objective of this training is to impart knowledge and skills for the application of ethical and quality principles to the design, conduct, recording, and reporting of health research involving human participants based on the level of risk, to ensure a fit-for-purpose quality system. This has been formulated into five sequential modules to be delivered in a 4-day course. Four courses have been organized in the pilot phase (2014-2015). The courses have been evaluated and assessed based on course feedback (quantitative and qualitative data) collected during course implementation and qualitative email-based pre- and post-course evaluation. RESULTS: Participants were highly satisfied with the course content and its organization. The relevance and applicability of the course content resulted in positive feedback and an articulated willingness to adapt and disseminate the course. Action points to strengthen the training program have been identified, and showed the imminent need to develop a consensus with a broader range of key stakeholders on the final set of GHRP standards and means for implementation. CONCLUSIONS: There is an urgent need to harness the momentum to promote high-quality and ethical health research in LMICs through scaling up GHRP training and further development of GHRP principles into international standards.

Banning tobacco sales in Massachusetts' pharmacies.

Bans on the sale of tobacco products in pharmacies allow pharmacies to provide health information and services without the conflict of interest posed by concurrent tobacco sales. As health care providers, pharmacies are trusted sources of information for patients. The existence of tobacco products in pharmacies is contrary to their mission as a health care entity. By May 2012, a full 27 Massachusetts municipalities had banned the sale of tobacco products in health care institutions, including pharmacies. These bans covered 30% of the state's population.

Long-term follow-up of relapsed childhood acute lymphoblastic leukaemia.

We have reviewed the outcome after relapse in a cohort of 505 children with acute lymphoblastic leukaemia (ALL) seen at a single institution. The majority of relapses (74%) occurred within 3 years from diagnosis, and most involved the bone marrow alone or with overt extramedullary relapse. Early relapse was more common in children with T-ALL and those with unfavourable cytogenetics. Factors influencing second remission included length of first remission and type of relapse. Children who had not received previous cranial irradiation had a superior survival. The German relapse score involving length of first remission, site of relapse and immunophenotype was highly predictive of outcome: event-free survival with 95% confidence intervals at 6 years for patients who received modern treatment [intensive chemotherapy or bone marrow transplantation (BMT)] was 78% (51-92%) for standard risk, 41% (33-49%) for intermediate risk and 19% (10-31%) for highest risk. Retrospective comparison of BMT with chemotherapy showed no difference in the intermediate-risk group but a possible advantage in the highest risk group. Follow-up of 235 patients who relapsed after chemotherapy and received a third course of treatment showed an extremely high early attrition rate, but a small number of patients survived in third remission. We conclude that new approaches are needed to individualize therapy in intermediate-risk patients and to improve the outcome for those in the highest risk group. Only a small number of children can be treated effectively in third remission.