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Objectives: Tobacco smoking is considered as one of the major global public health issues, especially in developing countries. Nowadays, pregnant women are suffering from the harm from second-hand smoke (SHS) and third-hand smoke (THS) exposure due to high rates of husband smoking, which are associated with several adverse clinical outcomes of pregnant women such as spontaneous abortion and postpartum depression. Methods: A national based cross-sectional study was conducted to examine the associations between different types of tobacco exposure and health-related quality of life (HRQoL) in pregnant women from different regions in China. A web-based questionnaire was asked during participation in prenatal examination. HRQoL was measured using the EuroQoL five-dimension-five-level (EQ-5D-5L) questionnaire and demographic data were collected. Results: 16,811 pregnant women were included and 51.8% of them were in different types of tobacco exposure. Significant difference in EQ-VAS scores were detected between non-tobacco exposure and tobacco exposure groups [First-hand smoke (FHS) (p=0.002), SHS (p,0.01) and THS (p,0.01)]. Moreover, increased amounts of SHS and THS exposure could result in lower HRQoL of pregnant women (p=0.039 and p=0.007 respectively). Conclusions: Approximately half of pregnant women were under the influence of different types of tobacco exposure. Compared to non-tobacco exposure, FHS, SHS and THS had negative impact on the HRQoL of pregnant women. Deleterious effect of tobacco exposure on HRQoL of pregnant women was in dose-response relationship. Tobacco exposure is common and severe health problem causing economic burden. Government need to make more relevant policies to limit not only FHS and SHS exposure but also THS exposure, which was ignored in the past.

Background: Most early-stage breast cancer (EBC) patients (pts) do not experience signs or symptoms of disease; approximately 90% of women diagnosed in breast screening are asymptomatic in the US (Ryerson et al. 2015). Rather, side effects of cancer therapy have the greatest impact and can be burdensome to pts on and after treatment. Bother and impact have not been thoroughly assessed from the patient perspective in trials. Qualitative research with 56 pts undergoing or completing (after 3 and within 24 mos of) systemic treatment were conducted to assess the need for EBC-focused patient-reported outcome (PRO) measures. Methods: Semi-structured interviews were conducted to better understand the treatment experience; the interview guide was developed in consultation with breast cancer advocates who were former pts. The interview sample was determined to capture findings across EBC therapies (HER2-targeted [HER2], hormone/endocrine [H/E], and/or chemotherapy [CT]). Treatment experience, including treatment-related symptoms and treatment impact (e.g. on activities of daily living, emotional aspects) were discussed in each 90-minute session. Pts rated level of bother of symptoms and impacts on an 11-point scale. Disease stage, treatment received, surgery, and other health information was collected from medical charts. Qualitative analysis was conducted with ATLAS.ti software. Symptom data was reviewed to appropriately analyze therapy subgroups. Results: Stage Ia (17.9%), Ib (14.3%), IIa (32.1%), IIb (25.0%), or IIIa (7.1%) pts that received adjuvant (75%) or neoadjuvant (25%) therapy participated; 106 unique treatment-related symptoms were reported. Symptoms most frequently reported included hair loss (86.7%), change in taste (73.3%), and tiredness/fatigue (71.1%) on CT (n=45); tiredness/fatigue (34.8%), runny nose (26.1%), and watery eyes (21.7%) on HER2 (n=23); and hot flashes (50.0%), joint pain (37.5%), and weight gain (20.1%) on H/E (n=24). The most common symptoms reported after therapy completion included memory loss (63.6%), symptoms of neuropathy (numbness, tingling, and pain in fingers, 63.6%), and tiredness/fatigue (45.5%) (n=11). CT symptoms rated by ≥ 25% of pts that were most bothersome included tiredness/fatigue (x -=8.2, n=18**), hair loss (x -=8.2, n=32**), and memory loss (x -=7.7, n=15**). HER2 and H/E ratings of bother were less frequent. EBC treatment was associated with significant impact on pts' lives; categories described are below: Impact category Average bother rating* (n**)Concerns with treatment9.5 (2)Physical/functional7.7 (36)Work or school7.5 (37)Sleep7.5 (21)Daily tasks and activities7.4 (95)Emotional7.4 (62)Sexual behavior7.1 (22)Cognitive function6.8 (6)Social6.7 (54)Appearance6.5 (32)* Rating on 11-pt scale; 0=none to 10=extremely bothersome ** n=number of patients rating the level of bother Conclusion: Treatment-related symptoms and associated degree of bother differed by treatment group. Pts' descriptions of treatment impact provided additional insight into the burden of EBC. EBC-specific PROs included in trials that gain pts' perspective on experience with treatment would further inform pts and may also inform therapy choice. Citation Format: Petersen JA, Gauthier MA, Piault E, DeBusk KPA, Buzaglo JS, Eng-Wong J, Glazer JR, Green MC, Johnson JM, Spears PA, Evans CJ. Importance of the patient voice in drug development: Early-stage breast cancer and measurement gaps concerning the treatment experience. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P1-10-20.