The number of people suffering from chronic disease has been increasing in recent years across developed and developing countries (Hoffman, Rice, & Sung, 1996; Newman, Steed, & Mulligan, 2004). According to a nationwide survey regarding the incidence of diabetes in Japan (Japan Ministry of Health, Labour and Welfare, 2007), the number of people who are suspected to be diabetic or who are already receiving treatment for diabetes has rapidly risen from 7.4 million people in 2002 to 8.9 million in 2007. This is an increase of approximately 20% in a 5 year period. To manage this growing problem, a new health policy targeting metabolic syndrome (MetS) was legislated by the Japanese Ministry of Health, Labor and Welfare in 2008 (Japan Ministry of Health, Labor and Welfare, 2008). The main elements of this policy are Specific Medical Examination (SME) and Specific Health Consultation (SHC), with the former being offered to people aged between 40 and 74 years, and the latter being provided to people who have been identified as having MetS risk factors.
The causes of many common chronic diseases are related to diet, physical activity, and other lifestyle factors, where self-management and self-monitoring behaviors often determine the symptoms and the prognosis of the disease (Kawaguchi, 1993). To address this challenge, many developed countries have begun to adopt self-management education programs (Newman et al., 2004; Osborne, Batterham, & Livingston, 2011). These are gaining in popularity because of their potential to improve the health of those affected by chronic disease as well as their potential to reduce medical costs.
Evaluation of self-management programs often includes clinical outcomes. However, such effects are not necessarily observed due to weak intervention and study design, short follow-up periods, and problematic evaluation tools (Warsi, LaValley, Wang, Avorn, & Solomon, 2003; Warsi, Wang, LaValley, Avorn, & Solomon, 2004). Therefore, there is an increasing need for precise evaluation of self-management program outcomes (Osborne et al., 2011). Faced with a similar lack of appropriate instruments in Australia, Osborne and colleagues developed the Health Education Impact Questionnaire (heiQ) in 2007 to improve the measurement of outcomes of self-management education interventions (Nolte, Elsworth, Sinclair, & Osborne, 2007; Osborne, Elsworth, & Whitfield, 2007). The heiQ was developed through extensive stakeholder consultation and consists of eight independent scales. The most prominent feature of the heiQ is its breadth and its capability of evaluating individuals' ability to manage their chronic condition irrespective of the type of underlying disease.
Metabolic syndrome is a complex range of major risk factors for chronic disease and the aim of the SHC was developed to reduce the risk of chronic disease and improve health outcomes in affected individuals (Japan Ministry of Health, Labor and Welfare, 2008). Importantly, the SHC is outcome-focused. However, the evaluation of outcomes alone is considered insufficient to evaluate the quality of health service delivery. Instead, a combined evaluation of outcomes and the health consultation process is believed to be necessary (Hasegawa, 2002). In view of the considerable overlap between the SHC and self-management education, the present authors recognized the potential of using the heiQ to evaluate the SHC intervention in Japan. MetS, which is the focus of the SHC, is an early stage of lifestyle-related diseases. Compared with the subjects used in the initial development of the heiQ, subjects with MetS may only be consciously aware of a few specific symptoms. In this study, to enable subjects to respond to all heiQ items appropriately, regardless of whether they were aware of the presence of symptoms or their health status, small changes were made to the original questionnaire to ensure the Japanese version was widely applicable across asymptomatic and symptomatic conditions. The aim of the current study, therefore, was to adapt and validate a Japanese version of the heiQ (heiQ-J) for the evaluation of the SHC.