Passive Smoking & Lung Cancer in Non Smoking Japanese Women Prospective

Study 2:

Passive smoking and lung cancer in Japanese non-smoking women- A prospective study

Read the respective studies and answer the following:

1. Explain the study design (20 points)
2. Explain how (or how not) the study question meets the FINER requirement (25 points)
3. List the study endpoints (20 points)
4. List the measurement tools (20 points)
5. Explain if or (if not) the study endpoints are correctly selected to match the study objectives (15 points)

   

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Int. J. Cancer: 122, 653–657 (2008) ‘ 2007 Wiley-Liss, Inc. Passive smoking and lung cancer in Japanese non-smoking women: A prospective study Norie Kurahashi1*, Manami Inoue1, Ying Liu1, Motoki Iwasaki1, Shizuka Sasazuki1, Tomotaka Sobue2 and Shoichiro Tsugane1 for the JPHC Study Group 1 Epidemiology and Prevention Division, Research Center for Cancer Prevention and Screening, National Cancer Center, 5-1-1 Tsukiji Chuo-ku, Tokyo, Japan 2 Cancer Information Services and Surveillance Division, Center for Cancer Control and Information Services, National Cancer Center, 5-1-1 Tsukiji Chuo-ku, Tokyo, Japan Although smoking is a major cause of lung cancer, the proportion of lung cancer cases among Japanese women who never smoked is high. As the prevalence of smoking in Japan is relatively high in men but low in women, the development of lung cancer in nonsmoking Japanese women may be significantly impacted by passive smoking. We conducted a population-based prospective study established in 1990 for Cohort I and in 1993 for Cohort II. The study population was defined as all residents aged 40–69 years at the baseline survey. 28,414 lifelong non-smoking women provided baseline information on exposure to tobacco smoke from their husband, at the workplace and during childhood. Over 13 years of follow-up, 109 women were newly diagnosed with lung cancer, of whom 82 developed adenocarcinoma. Compared with women married to never smokers, hazard ratio (HR) [95% confidence interval (CI)] for all lung cancer incidence in women who lived with a smoking husband was 1.34 (95% CI 0.81–2.21). An association was clearly identified for adenocarcinoma (HR 2.03, 95% CI 1.07–3.86), for which dose-response relationships were seen for both the intensity (p for trend 5 0.02) and amount (p for trend 5 0.03) of the husband’s smoking. Passive smoking at the workplace also increased the risk of lung cancer (HR 1.32, 95% CI 0.85– 2.04). Moreover, a higher risk of adenocarcinoma was seen for combined husband and workplace exposure (HR 1.93, 95% CI 0.88–4.23). These findings confirm that passive smoking is a risk factor for lung cancer, especially for adenocarcinoma among Japanese women. ‘ 2007 Wiley-Liss, Inc. Key words: lung cancer; passive smoking; histological type; prospective study; Japanese non-smoking women In Japan, lung cancer has been the second leading cause of cancer death in women since the 1980s.1 Although the majority of lung cancers can be attributed to cigarette smoking, 53% of all women with lung cancer world-wide are never smokers.2,3 The proportion of Japanese female lung cancer patients who have never smoked is as high as 70%,4 whereas the proportion of Japanese women aged 20 or more who smoke is only around 10%.5 The major risk for lung cancer in Japanese women cannot therefore be attributed to smoking. Given that the urine of non-smokers exposed to passive smoking contains concentrations of carcinogenic N-nitroso compounds, which are specific to tobacco6 and the smoking rate in Japanese men is high, at around 50%,5 passive smoking might be an important risk factor for lung cancer in nonsmoking Japanese women. Since the publication of the first positive findings by Hirayama in Japan, many studies have investigated the relation between passive smoking and lung cancer in non-smoking women.7 Recently, the International Agency for Research on Cancer (IARC) concluded that findings on the risk of lung cancer associated with environmental tobacco smoke were consistent.8 Moreover, a meta-analysis of published studies estimated that the excess risk of lung cancer in non-smokers who lived with a smoker compared to those who lived with a non-smoker was 24%.9 However, relatively few prospective studies have appeared,7,10–16 and almost all of previous studies have been case–control studies, for which the limitation of recall bias is controversial.17–37 Additionally, information on spousal smoking status in most of the prospective studies has been obtained from wives. The accuracy of this exposure evaluation is questionable, however, because while high concordance has been shown between information on spousal ever smoking from wives and data from husbands themselves, agreement on the duration and intensity of smoking is lower.38,39 Further, few prospective studies have considered the importance of multiple sources of exposure to passive smoking.15,16 Members of the JPHC Study Group (principal investigator: S. Tsugane): S. Tsugane, M. Inoue, T. Sobue and T. Hanaoka, Research Center for Cancer Prevention and Screening, National Cancer Center, Tokyo; J. Ogata, S. Baba, T. Mannami and A. Okayama, National Cardiovascular Center, Suita; K. Miyakawa, F. Saito, A. Koizumi, Y. Sano, I. Hashimoto and T. Ikuta, Iwate Prefectural Ninohe Public Health Center, Ninohe; Y. Miyajima, N. Suzuki, S. Nagasawa, Y. Furusugi and N. Nagai, Akita Prefectural Yokote Public Health Center, Yokote; H. Sanada, Y. Hatayama, F. Kobayashi, H. Uchino, Y. Shirai, T. Kondo, R. Sasaki, Y. Watanabe and Y. Miyagawa, Nagano Prefectural Saku Public Health Center, Saku; Y. Kishimoto, E. Takara, T. Fukuyama, M. Kinjo, M. Irei and H. Sakiyama, Okinawa Prefectural Chubu Public Health Center, Okinawa; K. Imoto, H. Yazawa, T. Seo, A. Seiko, F. Ito and F. Shoji, Katsushika Public Health Center, Tokyo; A. Murata, K. Minato, K. Motegi and T. Fujieda, Ibaraki Prefectural Mito Public Health Center, Mito; K. Matsui, T. Abe, M. Katagiri and M. Suzuki, Niigata Prefectural Kashiwazaki and Nagaoka Public Health Center, Kashiwazaki and Nagaoka; M. Doi, A. Terao, Y. Ishikawa and T. Tagami, Kochi Prefectural Chuo-higashi Public Health Center, Tosayamada; H. Sueta, H. Doi, M. Urata, N. Okamoto and F. Ide, Nagasaki Prefectural Kamigoto Public Health Center, Arikawa; H. Sakiyama, N. Onga, H. Takaesu and M. Uehara, Okinawa Prefectural Miyako Public Health Center, Hirara; F. Horii, I. Asano, H. Yamaguchi, K. Aoki, S. Maruyama, M. Ichii and M. Takano, Osaka Prefectural Suita Public Health Center, Suita; S. Matsushima and S. Natsukawa, Saku General Hospital, Usuda; M. Akabane, Tokyo University of Agriculture, Tokyo; M. Konishi, K. Okada and I. Saito, Ehime University, Toon; H. Iso, Osaka University, Suita; Y. Honda and K. Yamagishi, Tsukuba University, Tsukuba; H. Sugimura, Hamamatsu University, Hamamatsu; Y. Tsubono, Tohoku University, Sendai; M. Kabuto, National Institute for Environmental Studies, Tsukuba; S. Tominaga, Aichi Cancer Center Research Institute, Nagoya; M. Iida, W. Ajiki and A. Ioka, Osaka Medical Center for Cancer and Cardiovascular Disease, Osaka; S. Sato, Osaka Medical Center for Health Science and Promotion, Osaka; N. Yasuda, Kochi University, Nankoku; S. Kono, Kyushu University, Fukuoka; K. Suzuki, Research Institute for Brain and Blood Vessels Akita, Akita; Y. Takashima, Kyorin University, Mitaka; E. Maruyama, Kobe University, Kobe; M. Yamaguchi, Y. Matsumura, S. Sasaki and S. Watanabe, National Institute of Health and Nutrition, Tokyo; T. Kadowaki, Tokyo University, Tokyo; Y. Kawaguchi, Tokyo Medical and Dental University, Tokyo and H. Shimizu, Sakihae Institute, Gifu. Grant sponsor: Ministry of Health, Labour and Welfare of Japan. *Correspondence to: Epidemiology and Prevention Division, Research Center for Cancer Prevention and Screening, National Cancer Center. 5-1-1 Tsukiji Chuo-ku, Tokyo 104-0045, Japan. Fax: 181-3-3547-8578. E-mail: [email protected] Received 12 June 2007; Accepted after revision 31 July 2007 DOI 10.1002/ijc.23116 Published online 12 October 2007 in Wiley InterScience (www.interscience.wiley.com). Publication of the International Union Against Cancer 654 KURAHASHI ET AL. Here, we identified married couples among subjects of a large prospective study in Japan, and examined the association between passive smoking from the husband and the risk of lung cancer in the non-smoking wife using smoking status information obtained from the husband himself. Further, we also analyzed the association between passive smoking from other sources (at the workplace or during childhood) in lifelong non-smoking women with lung cancer. Material and methods JPHC study The Japan Public Health Center-based Prospective study (JPHC Study) was launched in 1990 for the first population-based cohort (Cohort I) and in 1993 for the second (Cohort II). Cohort I covered 5 public health center (PHC) areas (Iwate, Akita, Nagano, Okinawa and Tokyo) and Cohort II covered 6 (Ibaraki, Niigata, Kochi, Nagasaki, Okinawa and Osaka). All study subjects were residents of Japanese nationality who lived in the study areas at the start of follow-up, and who were aged 40–59 in Cohort I and 40–69 in Cohort II. In the present analysis, we excluded all subjects from the Tokyo and Osaka areas because incidence data in Tokyo were not available and the study population in Osaka included health checkup examinees, and was thus not fully population-based. A population-based cohort of 57,591 men (Cohort I: 26,998; Cohort II: 30,593) and 59,103 women (Cohort I: 27,397; Cohort II: 31,706) was identified using population registries, which were maintained by the respective local governments. Details of the study cohorts have been described elsewhere.40 A self-administered questionnaire, which included smoking history, previous disease history, and other lifestyle factors, was distributed to all eligible registered residents in 1990 for Cohort I and in 1993–1994 for Cohort II. Completed questionnaires were collected from 45,452 men and 49,924 women, giving response rates of 79 and 84%, respectively. To assess the carcinogenic effect of passive smoking exposure from the spouse, we further identified 31,261 pairs as married couples by surname, address, sex and an age difference of less than 16 years. To clarify the effects of passive smoking, we restricted analysis to lifelong nonsmoking women only. A further 711 women with a history of cancer at any site were excluded. Thus, 28,414 women were left for analysis. The accuracy of identification was tested in 644 pairs using residence registries; results showed 604 pairs (93.8%) were married couples and 6 (0.9%) were relatives other than a spouse, while the relationship of 34 pairs (5.3%) could not be established. The questions on smoking habit consisted of current and former smoking status, age at the initiation of smoking, average number of cigarettes smoked per day, and age at the cessation of smoking for former smokers. We determined that a woman who had a husband with a history of smoking had been exposed to passive smoking from her husband. We classified the passive smoking status of a woman by smoking status information from her husband himself (never, former, current), the number of cigarettes smoked per day (

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