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BackgroundFlavoured cigarettes are popular in Mexico. We examined how cigarette packaging design features used to communicate flavour influence perceptions of appeal, harm, perceived interest and pack preference among Mexico City residents.MethodsWe conducted an experimental survey. Participants aged 13–34 years were randomly assigned to one of three conditions, viewed packs with systematically manipulated design features (colour, capsule image and flavour name) and answered questions on appeal, perceived harm, perceived interest and pack preference. Data were analysed using mixed effects and conditional logistic regression.Results1500 adolescents and 950 adults participated. Regardless of flavour, cigarette packs with a background colour and capsule image were more appealing to adolescents (OR=13.19, 95% CI 11.53 to 15.10; OR=1.68, 95% CI 1.45 to 1.88) and adults (OR=4.18, 95% CI 3.73 to 4.69; OR=1.66, 95% CI 1.49 to 1.85) than packs without. Among adolescents, ‘Tropical Burst’ named packs were more appealing (OR=1.43, 95% CI 1.20 to 1.72) than packs without a flavour name and among adults, ‘Arctic Air’ named packs were more appealing (OR=1.20, 95% CI 1.02 to 1.14). Adolescents and adults reported a preference for trying packs that displayed a flavour name, background colour or capsule image (b=0.104, b=0.702, b=1.316, pConclusionsColours and flavour capsule images appeal to adolescents and adults in Mexico. Mexico should consider adopting plain packaging to reduce appeal and interest.

Purpose: To better understand the impact of cancer and treatment on outcomes and guide program development, we evaluated breast cancer survivors at risk for long-term medical and psychosocial issues who participated in survivorship care visits (SVs) at Johns Hopkins Hospital.Methods: We conducted a prospective survey study of women with stage I-III breast cancer who participated in SVs from 2010-2016. The same 56-item questionnaire administered at SV and follow-up included an assessment of symptoms, social factors, demographics, anxiety, depression, and comorbidities. We added the Godin Exercise questionnaire to the follow-up. Results: In 2018, 74 participants were identified as disease-free and mailed a follow up survey; 52 (70.3%) completed the survey. At a median follow-up time of 3.1 years after diagnosis, participants were less likely to be employed (54% vs. 67%) than at the SV. About two thirds were sedentary, and this was associated with high body mass index (p=0.02). Sufficiently active participants (≥150 minutes per week of moderate intensity activity) were less likely to report pain (p=0.02) or fatigue (p=0.001). Although 20% had moderate/severe anxiety or depression at follow up, participants who reported employment satisfaction were less likely to be depressed (p=0.02). Conclusions: Awareness of issues faced by survivors is critical for enhancing care and developing models to identify patients who might benefit most from targeted long term interventions.Implications for Cancer Survivors: Interventions to address physical activity, persistent symptoms and mental health are critical for breast cancer survivors.

Introduction Cigarettes designed to have less smoke smell were developed by the tobacco industry to supposedly reduce negative qualities. Cigarettes with marketing claims communicating these designs have been sold in high-income countries and marketing of “less smoke smell” terms on cigarette packaging can promote cigarette use. It is unclear to what extent they have been marketed in low- and middle-income countries (LMICs). Aims and Methods The Tobacco Pack Surveillance System (TPackSS) systemically collected tobacco packs available in 14 LMICs with high tobacco use between 2013 and 2017. We coded 4354 packs for marketing appeals, including claims related to smoke smell. We describe “less smoke smell” and similar claims found on these packs and compare across country and tobacco manufacturers. Results Phrases communicating less smoke smell were present on packs purchased in nine of 14 LMICs, including Bangladesh, Brazil, China, India, Mexico, Philippines, Russia, Ukraine, and Vietnam. The most commonly (74.1%) used terminology was “less smoke smell,” “LSS,” or a combination of the two. Packs from Russia had the most prevalent use (11.8%) of such claims. Companies using these terms across 21 brands included Japan Tobacco International (JTI), British American Tobacco (BAT), Philip Morris International (PMI), and other smaller companies. JTI accounted for 70.9% of packs with such terms. Conclusions Some of the world’s largest tobacco companies are communicating less smoke smell on packs in LMICs. Less smoke smell and similar phrases on packaging should be prohibited because they can enhance the appeal of cigarettes. Implications Tobacco companies are using “less smoke smell” and similar phrases on cigarette packs in LMICs. These claims have the potential to increase the appeal of smoking and promote cigarette use. Countries should consider policies to restrict attractive labeling claims, in accordance with the WHO Framework Convention on Tobacco Control (FCTC) Article 13 guidelines, which recommends restrictions on attractive design elements on tobacco packaging.

Survivorship care plans (SCPs) are recommended to promote appropriate follow-up care, but implementation has been limited. We conducted a randomized controlled trial comparing three SCP delivery models in two health systems. We utilize mixed methods to compare the feasibility and participants’ perceived value of the three models. Patients completing treatment for stage I–III breast, prostate, or colorectal cancer from one urban-academic and one rural community cancer center were randomized to (1) mailed SCP, (2) SCP delivered during an in-person survivorship visit, or (3) SCP delivered during an in-person survivorship visit plus 6-month follow-up. Clinics had flexibility in intervention implementation. Quantitative data summarize intervention fidelity and protocol deviations. Qualitative interview data provide patients’ perspectives on feasibility and intervention value. Of 475 eligible participants approached, 378 (79%) were randomized. Of 345 SCPs delivered, 265 (76.8%) were by protocol. Protocol deviations were more common at the urban-academic center. In post-study qualitative interviews, participants recalled little about the SCP document or visit(s). SCPs were valued for information and care coordination, although their static nature was limiting, and sometimes SCP information differed from that provided elsewhere. Visits were opportunities for care and reassurance, but time and distance to the clinic were barriers. SCP provision was challenging. Patients were interested in SCP, but not necessarily additional survivorship visits, particularly at the urban-academic hospital. These findings suggest that patients value careful consideration of health care needs during the transition out of treatment; SCP documents are one element of this. For many patients, models without additional visits and dynamic SCPs may be preferred.

Latinos/as - the largest minority group in the U.S. - are avid Facebook users, making this an opportune tool to educate on the uptake of cancer prevention and screening behaviors. However, there is a dearth in scholarship exploring how Latinos/as engage with and act upon health content encountered on social media, which may be influenced by cultural values. This qualitatively-driven, mixed-methods study explores how Latinos/as engage with and act upon cancer prevention and screening information (CPSI) on Facebook. During one-on-one, in-depth interviews, participants (n = 20) logged onto their Facebook account alongside the researcher and discussed cancer-related posts they engaged with during the past 12 months. Interview questions included the reasons for engagement, and whether engagement triggered further action. Interviews were analyzed thematically. In parallel, a content analysis of the CPSI posts identified during the interviews was conducted. The majority of CPSI posts participants engaged with contained food-related content and visual imagery. Engagement was most common when individuals had personal relationships to the poster, when posts included videos/images, and when posts contained content promoting the curative properties of popular Latin American foods. Engagement often led to information-seeking and sharing, discussing content with others, and/or changing health behaviors. Findings highlight the importance of adequately contextualizing how cultural values influence the ways in which Latinos/as engage with and act upon CPSI on Facebook, which may lead individuals to bypass evidence-based procedures. Multi-pronged efforts are necessary to adequately leverage social media to empower Latinos/as to partake in behaviors that effectively reduce cancer health disparities.

Introduction South Koreans continue to smoke at high rates. Tobacco manufacturers have a history of branding cigarettes with misleading descriptors including the introduction of low or ultra-low tar brand variants. The government bans traditional misleading descriptors (low, mild) but requires the presence of machine-assessed tar yields on cigarette packages. Literature suggests the presence of quantitative constituents can be misleading for smokers. We analyzed the machine-assessed tar value branding and the presence of additional branding that highlight tar levels on South Korean cigarette packs. Methods In August 2018, we analyzed 178 unique cigarette packs purchased in Seoul and Busan, South Korea using a systematic protocol. Cigarette packs were coded for tar levels and classified as ultra-low, low, mid, and high tar. The presence of misleading descriptors and any additional branding relating to tar or potentially indicating strength were also coded. Results Machine-assessed tar yields ranged from 0.1 to 8 mg. Cigarettes with a 1 mg machine-assessed tar yield accounted for 38% of all packs purchased. A majority (80%) of packs with tar values

Objectives: The tobacco industry can attract consumers using appealing packaging, including pack structure. We assessed the variety of pack structure elements across select low- and middle-income countries (LMICs). Methods: Between 2013 and 2017, we systematically collected 3542 packs from 14 LMICs. The selected countries represented LMICs with the greatest number of smokers. We assessed packs for 4 packaging structure elements: pack-type (hard, soft, or box), pack-shape, pack-edge, and opening-style. We used descriptive statistics to analyze the packag- ing structure elements by country and tobacco company. Results: All 14 countries assessed had predominantly hard packs (88.3% of the total sample). We identified 5 pack-shape variants; the most common pack-shape in all countries was the rectangular non-slim pack-shape (79.2%). Straight right-angled edge packs were the most common in 11 of the 14 countries assessed, but rounded edge packs were the most common in Turkey (58.5%). We found 9 broad categories of pack-opening styles, with the most common being the flip-top (94.5%). Conclusion: Although we found common packaging structure elements across the 14 LMICs, we also noted diverse packaging structures. Restrictions on pack structure elements are important as these elements can contribute to the attractiveness of tobacco products.

BackgroundChina is the country with the highest burden of tobacco-caused disease. We characterised the extent to which cigarette pack marketing features (eg, imagery, text, pack color) could potentially mislead consumers by suggesting products are healthy.MethodsWe used two methods: group concept mapping and content analysis. First, we used a group concept mapping approach to generate and sort Chinese consumer responses to an open-ended prompt asking what marketing features suggest a product is ‘healthy’ or ‘good for you’. Second, based on the concept mapping results, we developed a codebook of health-related features on cigarette packs that were relevant to the unique cultural context of product marketing in China. Two trained coders who were native Chinese speakers double-coded a sample of 1023 cigarette packs purchased in 2013 (wave 1) and 2017 (wave 2). We examined differences in the presence of features overall and over time.ResultsOverall, 83.5% (n=854) of Chinese cigarette packs in our sample contained at least one ‘healthy’ or ‘good for you’ feature, and the presence of health-related features on packs remained constant between wave 1 (83.5%, n=354) and wave 2 (83.5%, n=500; p=1.00). Across both waves, the most common categories of culturally specific health features present related to recycling symbols, rare animal imagery, bright colours (eg, bright yellow) and botanical imagery (eg, bamboo, mint).ConclusionHealth-related features on cigarette packs sold in China are common. Enhanced policies to address tobacco packaging, labelling and branding could support and facilitate a reduction in the high tobacco burden in China.

The recent COVID-19 pandemic has affected the world and has the potential to disproportionately affect and disrupt the lives of cancer survivors, including those currently in treatment, those who have completed treatment, and those who are now living cancer-free. There are currently over 17 million cancer survivors in the USA [1] and millions more around the world [2, 3]. Much has been published over the past several decades about the late and long-term effects of cancer treatment, alongside both the challenges and potential solutions to help patients navigate the healthcare system in order to receive high-quality survivorship care [4, 5]. To date, a number of organizations have provided the cancer survivorship community (both patients and healthcare providers) recommendations pertaining to COVID-19 (Box 1). Unfortunately, at this time, there is limited evidence regarding the impact of COVID-19 on cancer survivors, particularly those who have completed treatment. As the pandemic continues to evolve and scientific evidence emerges, more directed recommendations and guidelines will follow. As editors of the Journal of Cancer Survivorship, the only international peer-reviewed publication dedicated to expanding and disseminating knowledge pertaining directly to this patient population, we wrote this commentary to describe how COVID-19 may impact the physical, psychosocial, and healthcare delivery concerns of cancer survivors. We hope that this information may be helpful in addressing the needs of cancer survivors at the present time and frame the issues that will warrant attention in the future.

Objectives: In this paper, we assess compliance of cigarette packaging with policies in 9 countries that ban misleading descriptors, assess the presence of other packaging design elements that are misleading to consumers, and identify policy loopholes. Methods: Cigarette packages were systematically collected in 9 countries between 2015 and 2017 – Bangladesh, Brazil, China, India, Indonesia, Philippines, Russia, Thailand, and Vietnam. The packs were coded for banned misleading descriptors and other misleading packaging design elements. Descriptive analyses were conducted. Results: Overall, compliance with explicitly banned misleading descriptors is high across countries, with the exception of packs from Indonesia, where compliance is mod- erate. However, the use of other misleading packaging elements such as alternative descriptors (soft, smooth, mellow), select color descriptors (blue, gold, silver), and a slim pack shape are still widely used in packaging design across the 9 countries examined. Conclusions: Policies that include loopholes or allow for other misleading packaging design elements could weaken the impact of recommended misleading packaging and labeling regulations as laid out in the WHO Framework Convention on Tobacco Control. Stronger provisions are needed and countries should consider comprehensive plain packaging.

ObjectiveWe determined which countries prohibit flavoured tobacco products and the details of those restrictions in order to identify possible gaps and opportunities for these and other countries to address.MethodsWe reviewed the grey literature, scanned news articles and consulted with key informants and identified 11 countries and the European Union (EU) that ban or restrict tobacco product flavours. We reviewed policy documents for their stated policy rationale, terms and definitions of flavours, tobacco products covered and restrictions on the use of flavour imagery and terms on tobacco product packaging.ResultsCountries with a tobacco product flavour policy include the USA, Canada, Brazil, Ethiopia, Uganda, Senegal, Niger, Mauritania, EU (28 Member States), Moldova, Turkey and Singapore. Most of the countries’ policies provide a rationale of dissuading youth from taking up tobacco use. Ten of the 12 policies use the terms ‘flavours’ (n=6) or ‘characterising flavours’ (n=4). Six policies cover all products made entirely or partly of tobacco leaf. Countries consistently prohibit flavours associated with fruits, vanilla and spices. The USA and Niger make an exception for menthol, while Mauritania and Uganda do not specify the scope of flavours or ingredients covered by their policies. Eight policies make no specific reference to restricting flavour descriptors on tobacco product packaging.ConclusionCountries looking to implement policies restricting flavours in tobacco products can build on existing comprehensive policies. Future research could examine the implementation and impacts of these policies, to inform other countries interested in acting in this policy domain.

Background: Standard surgical techniques result in positive lumpectomy margins 20-40% of the time. These positive margins require surgical re-excision which places significant burden on the healthcare system and patients. The LUM Imaging System consists of a fluorescent drug, a hand-held wide-field detector (LUM Imaging Device) used to image the surgical cavity walls intraoperatively in real-time after the resection of the main lumpectomy specimen, and a proprietary tumor detection algorithm that highlights regions in the tumor bed suspected to contain residual cancer. Methods: The Intraoperative Detection of Residual Cancer in Breast Cancer trial (NCT03321929) is a non-randomized, open-label, multi-site trial. This is a prospective, interventional feasibility study and is a pilot arm to a pivotal study which will further evaluate the safety and efficacy of the LUM Imaging System. This study enrolls women, over the age of 18 and with histologically or cytologically confirmed primary invasive breast cancer (IBC), ductal carcinoma in situ (DCIS) or a combination of IBC/DCIS undergoing a lumpectomy for their breast malignancy. LUM015, a fluorescent drug, is injected prior to the subject’s lumpectomy procedure. Surgeons perform their standard of care lumpectomy followed by intraoperative imaging of the lumpectomy cavity with the LUM Imaging System. In real-time, the LUM Imaging System highlights areas within the tumor bed that may contain, residual abnormal tumor tissue. Surgeons remove additional tissue based on the guidance of the LUM Imaging System. A maximum of two additional tissue shaves may be obtained. All excised tissue specimens are evaluated by routine pathology and correlated to the output of the LUM Imaging System. Results and Discussion: Sixteen medical centers across the United States enrolled 234 subjects into this study. Preliminary data on 141 subjects has been evaluated. The median age of enrolled women undergoing surgery using the Lumicell system was 61 years old. The histology of tumor type in women evaluated in this analysis is representative of the general population, with 21% diagnosed with ductal carcinoma in-situ (DCIS), 11% diagnosed with invasive lobular carcinoma, and 64% diagnosed with invasive ductal carcinoma (with or without DCIS features present). Most women (71%) presented with a palpable mass on physical examination prior to their lumpectomy surgery. Radiological imaging prior to lumpectomy showed scattered areas of fibroglandular density in 49% of the enrolled subjects and heterogeneously dense breast tissue in 42% of the enrolled subjects. The use of the LUM Imaging System positively impacted enrolled subjects; approximately 10% of subjects (N=14) had residual tumor detected and removed from the tumor bed guided by the LUM Imaging System after the standard of care surgery was completed. Without the use of this guidance technology, tumor tissue would have been left behind in this cohort of subjects, potentially requiring additional surgical intervention or other therapy, or local recurrence. The mean absolute volume of tissue removed due to guidance by the Lumicell System was 15 cc corresponding to about 15% of the total tissue removed. The LUM Imaging System correctly identified all positive margins in 28% of subjects with a positive margin after standard of care, and directed excision of additional tissue to create a wider margin. 12% of the patients with positive margins were converted to a negative margin by removing additional tissue guided by this imaging system. Future studies are planned that will measure the sensitivity and specificity of the device. Citation Format: Jorge Ferrer, David Carr, Peter Blumencranz, Daleela Dodge, Nayana Dekhne, Irene Wapnir, Kelly Hunt, Linsey Gold, Stephanie Valente, Peter Beitsch, Donna Dyess, Shelly Hwang, Lynne Clark, Beth-Ann Lesnikoski, Anees Chagpar, Stephen Karp, Brian Schlossberg, Sean Madden, Manna Chang, Kate Smith, David Strasfeld, W David Lee, Barbara Smith. Results from the expansion into multiple institutions for training in the use of the LUM imaging system for intraoperative detection of residual cancer in the tumor bed of female subjects with breast cancer clinical trial [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-20-06.

IntroductionExchanging or gifting cigarettes is a common practice in Chinese culture, often occurring during weddings to connote celebrations and happiness. We examined Chinese cigarette packs for wedding terminology and imagery to assess the extent to which packs are marketed for such occasions.MethodsCigarette packs were collected from Beijing, Guangzhou, Shanghai, Kunming and Chengdu in February 2017 using a systematic protocol designed to capture unique packs. Packs were coded by two independent coders for text and imagery of traditional Chinese wedding symbols, such as double happiness, dragon and phoenix, and other culturally specific phrases and images associated with weddings in China.ResultsFrom the sample of 738 unique cigarette packs, 68 (9.2%) contained either lexical and/or imagery appeals for wedding gifting. Of these 68 packs, 65 contained both lexical and imagery appeals, 1 pack had only a lexical appeal and 2 packs only included an imagery appeal. The most common appeal was ‘double happiness’ found on 56 packs (82.4%) for both lexical and imagery, followed by ‘dragon and phoenix’ found lexically on 12 packs (17.6%), and through imagery on 15 packs (22.1%).ConclusionsChinese tobacco manufacturers take full advantage of the cigarette gifting and sharing culture demonstrated by packs with imagery and terminology specific to weddings. With only a 35% text health warning label, manufacturers have much real estate to make packs attractive for gifting on such occasions. Implementing plain packaging policies may be effective in decreasing gifting attractiveness for cigarette packs.

Since the inception of the Journal of Cancer Survivorship (JCSU), the founding editor-in-chief, the associate editors, editorial board members, and peer reviewers have played important roles in influencing the knowledge base published in JCSU. The journal editors represent key disciplines, practice areas, and research expertise in cancer survivorship, which includes oncology and hematology, pediatric oncology, health psychology/behavior medicine, primary care, oncology nursing, exercise oncology, epidemiology, rehabilitation sciences, health services research, health policy, public health, and sociology. Over the years, the journal editors have worked to facilitate peer review and provide quality reviews to prospective authors. Earlier this year, Chan et al. [1] provided an overview of the evolution of JCSU since its inception in 2007 to 2020. Chan et al.’s [1] paper included a comprehensive description of the content, impact metrics, and top cited papers. In addition, they created a neural network using the key terms of published articles (Fig. 1) that depicted both minor and major themes published since the inception of JCSU.

Objective To evaluate the impact of integrating patient-reported outcomes (PROs) into routine clinics, from the perspective of patients with RA, clinicians and other staff. Methods We conducted a prospective cohort study using a mixed methods sequential explanatory design at an academic arthritis clinic. RA patients completed selected Patient-Reported Outcomes Measurement Information System measures on tablets in the waiting room. Results were immediately available to discuss during the visit. Post-visit surveys with patients and physicians evaluated topics discussed and their impact on decision making; patients rated confidence in treatment. Focus groups or interviews with patients, treating rheumatologists and clinic staff were conducted to understand perspectives and experiences. Results Some 196 patients and 20 rheumatologists completed post-visit surveys at 816 and 806 visits, respectively. Focus groups were conducted with 24 patients, 10 rheumatologists and 4 research/clinic staff. PROs influenced medical decision-making and RA treatment changes (38 and 18% of visits, respectively). Patients reported very high satisfaction and treatment confidence. Impact on clinical workflow was minimal after a period of initial adjustment. PROs were valued by patients and physicians, and provided new insight into how patients felt and functioned over time. Reviewing results together improved communication, and facilitated patient-centred care, shared decision making, and the identification of new symptoms and contributing psychosocial/behavioural factors. Conclusion PRO use at RA visits was feasible, increased understanding of how disease affects how patients feel and function, facilitated shared decision-making, and was associated with high patient satisfaction and treatment confidence.

Survivorship care plans (SCPs) provide key information about cancer treatment history and follow-up recommendations. We describe the completeness of breast cancer SCPs and evaluate guideline concordance of follow-up recommendations. We analyzed 149 breast cancer SCPs from two sites, abstracting demographics, cancer/treatment details, surveillance plans, and health promotion advice. SCP recommendations and provided information were compared to American Cancer Society/American Society of Clinical Oncology and National Comprehensive Cancer Network guidelines. SCP information provided in > 90% of the plans included patient age; relevant providers; cancer stage; treatment details; and physical exam, mammogram, and health promotion recommendations. SCP components completed less frequently included post-treatment symptoms/side effects (67%). All SCPs at the community site were uniform but had the potential for oversurveillance if visits occurred every 3 months in years 1–2 or every 6 months in years 3–5 with multiple cancer providers. The academic site recommended three predominant patterns of follow-up: (1) primary care provider every 6–12 months; (2) cancer team every 3–6 months (year 1), every 6–12 months (years 4–5); and (3) alternating oncology providers every 3–6 months (years 1–2) then every 6 months. Compared to guidelines, these patterns recommend under- and oversurveillance at various times. Mammography recommendations showed guideline concordance (annual) for 84%, oversurveillance for 10%, and were incomplete for 6%. SCPs of only 12/79 (15%) women on aromatase inhibitors recommended guideline-concordant bone density testing. SCP content is more complete for demographic and treatment summary information but has follow-up recommendation gaps. Efforts to improve follow-up recommendations are needed.

Background: Our objective was to examine mothers’ engagement with news coverage of pediatric injury research to inform effective mass communication of research findings that are crucial to enhancin...

Oncology has made significant advances in standardizing how clinical research is conducted and reported. The advancement of such research that improves oncology practice requires an expansion of not only our research questions but also the research methods we deploy to address them. In particular, there is increasing recognition of the value of qualitative research methods to develop more comprehensive understandings of phenomena of interest and to describe and explain underlying motivations and potential causes of specific outcomes. However, qualitative researchers in oncology have lacked guidance to produce and evaluate methodologically rigorous qualitative publications. In this review, we highlight characteristics of high-quality, methodologically rigorous reports of qualitative research, provide criteria for readers and reviewers to appraise such publications critically, and proffer guidance for preparing publications for submission to Journal of Oncology Practice. Namely, the quality of qualitative research in oncology practice is best assessed according to key domains that include fitness of purpose, theoretical framework, methodological rigor, ethical concerns, analytic comprehensives, and the dissemination/application of findings. In particular, determinations of rigor in qualitative research in oncology practice should consider definitions of the appropriateness of qualitative methods for the research objectives against the setting of current literature, use of an appropriate theoretical framework, inclusion of a rigorous and innovative measurement plan, application of appropriate analytic techniques, and clear explanation and dissemination of the research findings.

Published 2019. This article is a U.S. Government work and is in the public domain in the USA. This study explored patients' experiences and perceptions of living with thalassemia (an inherited hematologic disorder), perceptions of social stigma, and impact on disclosure decision-making. Semistructured, in-person interviews were conducted in Singapore with 30 individuals: 16 thalassemia major patients and 14 parents of children with thalassemia. Findings were indicative of felt or enacted stigma that may have influenced disclosure decisions. Although affected individuals commonly disclosed their thalassemia diagnosis to family members, they either downplayed the condition with or avoided disclosure to unrelated individuals. Disclosure outside the family occurred only in response to triggers, such as questions about absences due to medical care. Health professionals should provide anticipatory guidance about disclosure strategies when managing individuals with thalassemia.

Background: In patients with relapsing forms of multiple sclerosis (MS), relapses are often unrecognized. These missed relapses have broad implications for the conduct of clinical trials as well as for the care and prognosis of people with multiple sclerosis (MS). With the ultimate goal of developing new methods to identify relapse, the purpose of this qualitative research with patients and clinicians was to examine the definition, symptoms, and impact of relapse. Methods: This qualitative study involved semi-structured interviews with clinicians specializing in MS and people with relapsing-remitting (RR) MS. A brief literature review was conducted to inform the development of interview guides. Qualitative data were gathered from 10 clinicians in a series of individual interviews and one focus group, followed by a series of interviews with 20 patients. Thematic analysis was conducted using ATLAS.ti to identify concepts emerging from the interviews. Results: Both clinicians and people with MS tend to describe classic neurologic symptoms that are confirmable on exam as indicative of relapses (e.g., sensory changes, vision issues, and walking difficulties), while also acknowledging that several less quantifiable symptoms are common (e.g., fatigue, pain, and cognitive issues). Patients described far-reaching impacts of relapse beyond just the quantifiable manifestations of the disease evaluated by commonly-used measures of MS severity and disability. Conclusion: MS relapses, which have substantial impact on patient functioning, appear to include symptoms beyond those in typical definitions of relapse. Incorporating such constructs into new measures of relapse could lead to improved recognition of relapse episodes.

Background The burden of tobacco use In India is very high. To inform users of harm, India has a strong health warning label law that applies to all tobacco products. This study examines the extent of compliance of health warning labels on smokeless tobacco (SLT) and bidi products with the Indian law. Methods In 2017, a systematic protocol was used to collect unique SLT and bidi packages from five Indian states. To assess compliance, we used three indicators: location, label elements, and warning size. Results Only 1% of the 133 SLT products and none of the 32 bidi packs were compliant with all three compliance indicators. Other compliance-related issues included non-standardized packaging, incomplete health warning labels, poor printing quality, and old warning labels. Conclusion There is very poor compliance with the health warning label law on bidi and SLT products. India needs to regularly monitor and address implementation to ensure that warning labels are effective.

Objective: Limited research has examined feminine marketing appeals on cigarette packs in low-and middle-income countries (LMICs). We reviewed a systematically collected sample of cigarette packs sold across 14 LMICs in 2013 (Wave 1) and 2015–2017 (Wave 2).Methods: Packs in Wave 1 (n = 3,240) and Wave 2 (n = 2,336) were coded for feminine imagery and descriptors (flowers, fashion, women/girls, color “pink”). We examined trends in feminine appeals over time, including co-occurrence with other pack features (slim or lipstick shape, flavor, reduced harm, and reduced odor claims).Results: The proportion of unique feminine cigarette packs significantly decreased from 8.6% (n = 278) in Wave 1 to 5.9% (n = 137) in Wave 2 (p < 0.001). Among all feminine packs, flower-and fashion-related features were most common; a substantial proportion also used flavor and reduced odor appeals.Conclusion: While there was a notable presence of feminine packs, the decline observed may reflect global trends toward marketing gender-neutral cigarettes to women and a general contempt for using traditional femininity to market products directly to women. Plain packaging standards may reduce the influence of branding on smoking among women.

Introduction Gutka, a popular smokeless tobacco (SLT) product combining chewing tobacco, areca nut, and spices, was banned by states in India beginning in 2012. Gutka can be recreated by the user mixing twin packets of tobacco and spice mixtures. We examine the availability of premixed gutka, the sale of twin packets (chewing tobacco and spice mixture sold together but in separate packets) and whether SLT was sold without legally mandated health warning labels (HWLs), without the printed maximum retail price (MRP), and above the MRP. Aims and Methods In October/November of 2017, unique SLT packets were purchased using a systematic protocol in 25 localities with populations under 50 000 across five Indian states. Purchase information (location, twin packets, price paid) and packaging information (SLT type, printed MRP, type of HWL) were used to assess legality. Results Of the 240 purchases of unique SLT packets, three were premade gutka. Twin packets were half of the sample, sold in every state, and illegally sold in Maharashtra where they were banned. Over half (62%) of single packets and 27% of twin packets did not feature a legal HWL. While only 5% of packets did not have a printed MRP, 29% of single packets, and 38% of twin packets were sold illegally for more than the MRP. Conclusions SLT without the proper HWL or sold above the MRP were common. Twin packets were widely available. India should consider a country-wide restriction to ban single serving tobacco packets that would decrease affordability. Implications This study is the earliest and that first outside of Mumbai that we are aware of to present evidence of tobacco products being sold above the MRP in India. While finding little evidence of premade gutka being sold, we found twin packets (chewing tobacco and spice mixture packets sold together) are widely available even in Maharashtra, which has a policy in place to ban twin packets. This study also finds evidence of SLT products sold without the correct HWL and without a MRP listed which shows that implementation and enforcement of regulations are as important as passing regulations.

Background/Aims Enthesitis, which is the inflammation of the entheses area where the tendon or ligaments are attached into the bone, is considered a hallmark and pathological feature for spondyloarthropathies (SpA). The lower limb entheses are more prone to being affected than the upper extremity enthesis, the most common one is Achilles tendon where heel enthesitis is considered the most frequent finding in SpA patients. Ultrasound is widely used by rheumatologists because it has higher sensitivity and specificity in detecting enthesitis compared with clinical assessment. The abnormal characteristics of enthesitis in greyscale ultrasound includes the hypoechoic area at the insertion or body of the tendon due to the loss of the normal fibrillar pattern, increase in the tendon thickness, bone erosion, calcification and increase in Dopplar signals. Although ultrasound has many advantages compared with other imaging modalities, it is operator-dependent and the diagnosis is exposed to the subjectivity of the observer, which leads to the variability in defining the abnormal features of enthesitis. Using static ultrasound images of Achilles tendon entheses of patients with SpA, we first determined the intra- and inter-observer reliability of grading ‘hypoechogenicity’ using a panel of readers and second, compared a computerised pixel counting method against an expert consensus score to determine the level of agreement between approaches. Methods Six participants (rheumatologists and sonographer) with experience in ultrasound scored the presence of hypoechogenicity in 100 static images of Achilles tendon entheses of patients with SpA. Two scoring systems were used- an OMERACT derived SQ system (0-3) of the whole enthesis and binary score system of the distal 2mm (0-1). The intra-class correlation coefficient (ICC) and Cohen's kappa was used to assess inter-observer reliability. The ImageJ software was used to measure the mean grey values (MGV) of the pixels within the enthesis. Results The inter-observer reliability was good for using the SQ score (ICC 0.780 (95% CI 0.691-0.849) and moderate for the binary score (ICC 0.632 (95% CI 0.490-0.745)). There was no match between the results from the quantitative score of the pixels MGV and the expert semi-quantitative score. Conclusion This study is novel as in that it has specifically evaluated the scoring of hypoechogenicity within the entheses of patients with SpA. It has demonstrated variation in scoring between observers and highlighted the challenges of image interpretation. A lack of correlation of expert scoring with the manual pixel MGV was limited by the image artefacts and different machine settings which may have implications as we work towards future AI systems. Disclosure A.S. Aldahes: None. R. Wakefield: None. K. Smith: None.

Background Survivorship care plans contain important information for patients and primary care physicians regarding appropriate care for cancer survivors after treatment. We describe the completeness of prostate cancer survivorship care plans and evaluate the concordance of follow-up recommendations with guidelines. Methods We analyzed 119 prostate cancer survivorship care plans from one academic and one community cancer center, abstracting demographics, cancer/treatment details, and follow-up recommendations. Follow-up recommendations were compared with the American Cancer Society (ACS), American Society of Clinical Oncology (ASCO), and National Comprehensive Cancer Network (NCCN) guidelines. Results Content in >90% of plans included cancer TNM stage; prostate-specific antigen (PSA) at diagnosis; radiation treatment details (98% of men received radiation); and PSA monitoring recommendations. Potential treatment-specific side effects were listed for 82% of men who had surgery, 86% who received androgen deprivation therapy (ADT), and 97% who underwent radiation. The presence of posttreatment symptoms was noted in 71% of plans. Regarding surveillance follow-up, all guidelines recommend an annual digital rectal exam (DRE). No plans specified DRE. However, all 71 plans at the community site recommended at least annual follow-up visits with urology, radiation oncology, and primary care. Only 2/48 plans at the academic site specified follow-up visits. All guidelines recommend PSA testing every 6-12 months for 5 years, then annually. For the first 5 years, 90% of plans were guideline-concordant, 8% suggested oversurveillance, and 2% were incomplete. In men receiving ADT, ACS and ASCO recommend bone density imaging and NCCN recommends testosterone levels. Of 77 men on ADT, 1% were recommended bone density imaging and 16% testosterone level testing. Conclusions While care plan content is more complete for demographic and treatment summary information, both sites had gaps in reporting posttreatment symptoms and ADT-related testing recommendations. These findings highlight the need to improve the quality of information in care plans, which are important in communicating appropriate follow-up recommendations to patients and primary care physicians.

Introduction Flavors and depictions of flavors are attractive and facilitate initiation and use of tobacco products. However, little is known about the types of flavored products on the market, particularly in low- and middle-income countries. We describe the nature and extent of flavored cigarettes sold in nine low- and middle-income countries from four of the six World Health Organization (WHO) regions. Aims and Methods We employed a systematic protocol to purchase unique cigarette packs in Bangladesh, Brazil, China, India, Indonesia, Philippines, Russia, Thailand, and Vietnam. Packs were double coded for flavor descriptors and imagery using a standard codebook. Frequencies and crosstabs were conducted to examine the proportion of packs with flavor descriptors and/or flavor imagery, and flavor capsules, by country and by major manufacturer. Results Overall, 15.4% of the country-unique cigarette packs had flavor descriptors and/or imagery, representing a variety of flavors: menthol or mint (8.2%), “concept” descriptors (3.5%) (eg, Fusion blast), fruit or citrus (3.3%), beverages (1.4%), and others (1.4%). Flavor was mostly communicated using descriptors (15.2%), with flavor imagery being less common (2.2%). Flavor capsules were prevalent (6.2%), with almost half having “concept” descriptors. All major tobacco companies produced cigarettes with flavors, and with capsules. Conclusions A range of flavored cigarettes remain on the market in the low- and middle-income countries with the greatest number of smokers. This finding is particularly concerning given the appeal of flavored cigarettes among youth and their potential to circumvent country bans on flavored tobacco products if those laws are not sufficiently comprehensive. Laws addressing flavored tobacco products need to account for flavor capsules and concept descriptors. Implications While a number of countries have restricted flavors in tobacco products to reduce their appeal and attractiveness, a range of flavors continue to be on the market in low- and middle-income countries, putting people in these countries at increased risk for tobacco use and subsequent tobacco-caused death and disease. The presence of capsules and concept descriptors is particularly concerning given their appeal among youth and their potential to circumvent country bans on flavored tobacco products if those laws are not sufficiently comprehensive.

Approximately 10.5% of adults in Pakistan (about 13 million) smoke cigarettes,1 causing 134 000 deaths annually.2 To reduce the burden of disease, the Pakistan government implemented a requirement in 2010 for 40% pictorial health warning labels (HWLs) that depicted mouth cancer. A 2017 ruling to increase HWL size was implemented in August 2018 (50% throat cancer image) and August 2019 (60% gangrenous foot image).3 4 Pictorial HWLs increase smokers’ quit attempts, deter initiation of use among non-smokers, and prevent relapse in former smokers.5 In 2013, only 58% of unique packs with the current, in-rotation HWL were compliant with size, location, text contrast and text size requirements in Pakistan.6 In 2019, compliance with size, location and text language requirements was 82% (largely due to size compliance improvements) for unique packs displaying the most recent gangrenous foot HWL7; however, poor HWL …

Background Companies use brand websites as a promotional tool to engage consumers on the web, which can increase product use. Given that some products are harmful to the health of consumers, it is important for marketing associated with these products to be subject to public health surveillance. However, terms of service (TOS) governing the use of brand website content may impede such important research. Objective The aim of this study is to explore the TOS for brand websites with public health significance to assess possible legal and ethical challenges for conducting research on consumer product websites. Methods Using Statista, we purposefully constructed a sample of 15 leading American tobacco, alcohol, psychiatric pharmaceutical, fast-food, and gun brands that have associated websites. We developed and implemented a structured coding system for the TOS on these websites and coded for the presence versus absence of different types of restriction that might impact the ability to conduct research. Results All TOS stated that by accessing the website, users agreed to abide by the TOS (15/15, 100%). A total of 11 out of 15 (73%) websites had age restrictions in their TOS. All alcohol brand websites (5/15, 33%) required users to enter their age or date of birth before viewing website content. Both websites for tobacco brands (2/15, 13%) further required that users register and verify their age and identity to access any website content and agree that they use tobacco products. Only one website (1/15, 7%) allowed users to display, download, copy, distribute, and translate the website content as long as it was for personal and not commercial use. A total of 33% (5/15) of TOS unconditionally prohibited or put substantial restrictions on all of these activities and/or failed to specify if they were allowed or prohibited. Moreover, 87% (13/15) of TOS indicated that website access could be restricted at any time. A total of 73% (11/15) of websites specified that violating TOS could result in deleting user content from the website, revoking access by having the user’s Internet Protocol address blocked, terminating log-in credentials, or enforcing legal action resulting in civil or criminal penalties. Conclusions TOS create complications for public health surveillance related to e-marketing on brand websites. Recent court opinions have reduced the risk of federal criminal charges for violating TOS on public websites, but this risk remains unclear for private websites. The public health community needs to establish standards to guide and protect researchers from the possibility of legal repercussions related to such efforts.

Background Tobacco companies include on the packaging of their products URLs directing consumers to websites that contain protobacco messages. Online media tend to be underregulated and provide the industry with an opportunity to present users with protobacco communication. Objective The objective of our study was to document the content of websites that were advertised on tobacco packs in 14 low- and middle-income countries. Methods We purchased tobacco packs from 14 low- and middle-income countries in 2013 and examined them for the presence of URLs. We visited unique URLs on multiple occasions between October 1, 2016 and August 9, 2017. We developed a coding checklist and used it to conduct a content analysis of active corporate websites to identify types of protobacco communication. The coding checklist included the presence of regulatory controls and warnings, engagement strategies, marketing appeals (eg, description of product popularity, luxury/quality, taste), corporate social responsibility programs, and image management. We coded brand websites separately and also described social media and other website types. Results We identified 89 unique URLs, of which 54 were active during the search period. We assessed 26 corporate websites, 21 brand websites, 2 nontobacco websites, and 5 social media pages. We excluded 2 corporate websites and 14 brand websites due to limited accessible content or incomplete content. Corporate social responsibility was discussed on all corporate websites, and marketing appeals were also common. Corporate websites were also more likely to include more nonspecific (12/24, 50%) than specific (7/24, 29%) health warnings. Promotions (6/7, 86%) and sociability appeals (3/7, 43%) were common on brand websites. The small number of social media webpages in our sample used gendered marketing. Conclusions URLs appearing on tobacco packs direct consumers to websites where users are exposed to marketing that highlights the “positive” contributions of tobacco companies on corporate websites, and extensive promotions and marketing appeals on brand websites and social media pages. It is essential that marketing regulations become more comprehensive and ban all protobacco communication, a policy that is in line with articles 5.3 and 13 of the World Health Organization Framework Convention on Tobacco Control. For countries that already ban internet tobacco advertising, enforcement efforts should be strengthened. Tobacco companies’ use of URLs on packs may also be compelling for plain packaging advocacy, where all branding is removed from the pack and large graphic health warning labels are the only communication on the tobacco packaging. Future research should consider including tobacco websites in marketing surveillance.

The purpose was to test the feasibility, acceptability, and preliminary efficacy of a 4-session couple-based Intimacy Enhancement (IE) intervention addressing breast cancer survivors' sexual concerns delivered via telephone. Twenty-nine post-treatment breast cancer survivors reporting sexual concerns and their intimate partners were randomized (2:1) to the IE intervention or to an educational control condition, both of which were delivered by trained psychosocial providers. Feasibility and acceptability were measured through recruitment, retention, session completion, and post-intervention program evaluations. Couples completed validated sexual, relationship, and psychosocial outcome measures at pre- and post-intervention. Between-group effect sizes and 95% confidence intervals were calculated using the Hedges g. Data supported intervention feasibility and acceptability. For survivors, the IE intervention had medium to large positive effects on all sexual outcomes and most psychosocial outcomes. Effects were less visible for relationship outcomes and were similar but somewhat smaller for partners. The IE intervention demonstrated feasibility, acceptability, and promise in addressing breast cancer survivors' sexual concerns and enhancing their and their partners' intimate relationships and psychosocial well-being. Implications for Psychosocial Oncology Practice The IE intervention demonstrated feasibility and acceptability, suggesting it could be well-received by breast cancer survivors with sexual concerns and their partners. Effects of the IE intervention on breast cancer survivors' sexual concerns and on their and their partners' intimate relationships and psychosocial well-being could not be attributed to therapist time and attention. Interventions that psychosocial providers can use to address breast cancer survivors' sexual concerns are important to the growing number of breast cancer survivors living for many years after their diagnosis.

Recruitment challenges hinder behavioral intervention research in cancer survivors. The purpose was to examine the reasons for declining and intervention preferences of study-eligible breast cancer survivors declining a trial of a four-session couple-based Intimacy Enhancement intervention (refusers) and explore whether refusers differed from participants on key characteristics. Partnered, post-treatment breast cancer survivors reporting sexual concerns who were eligible for but declined participation in the intervention trial were approached to complete a standardized 5-min telephone survey assessing reasons for declining and support preferences. Demographic, clinical, and sexual concerns information were collected during screening. Trial participants and refusers were compared on key variables of age, race, hormone therapy use, time since treatment, level of sexual concerns, and recruitment method using t-tests or chi-square tests. Among the 31 women who declined the trial and completed the survey, the most common reasons for declining were time commitment (74%) and partner noninterest (32%). Most (61%) reported that the telephone format played little to no role in their refusal. Eighty-one percent wanted their partners involved in a program addressing sexual concerns. The two most preferred resources were informational websites (45%) and meeting with a professional (26%). Trial participants and refusers did not differ on any key factors examined. Developing intimacy interventions that are very brief, partner-optional, or that use stepped care may bolster uptake. The methods used to examine study-eligible candidates’ needs and preferences could be employed in other health populations, thus having broader implications for research design.