Key Points

• Quality of life has emerged as a valid tool to assess the impact of a specific disease on the well-being of affected individuals.
• GERD patients suffer from a significant impairment in their health-related quality of life.
• Effective therapy has the capacity to normalize these patients’ quality of life.
• Antireflux surgery has repeatedly been shown to correct these deficiencies in well-being, effects that do not subside with time.

Health is often assessed and measured by physicians in terms of survival and complications, but the concept was further expanded in 1948 when the World Health Organization defined health as “not only the absence of infirmity and disease but also a state of physical, mental and social well being.” Thus, a broader, more global concept of health was introduced that included both physical and mental dimensions. Quality of life (QOL) first emerged on the political agenda in the United States around 1950. Despite over half a century of research in this field, there is still no consensus as how to define QOL, but it is considered to be a broader concept than just health aspects.[1],[2],[3],[4]

Recently, the importance of QOL or patient-reported outcomes (PROs) has been emphasized by the U.S. Federal government during the conduct of clinical studies. The FDA calls for “the status of a patient’s health condition that comes directly from the patient without interpretation of the patient’s response by a clinician or anyone else.” [5] With passage of the Patient Protection and Affordable Care Act of 2010, the Patient-Centered Outcomes Research Institute (PCORI) has been established to facilitate further research in this area and exemplifies the importance of this approach to clinical outcomes research. PROs have taken on even more importance due to the use of QOL in determining quality adjusted life years (QALY) for various interventions and their cost effectiveness.

QOL is not a directly observable or measurable entity. To facilitate the operationalistic view of QOL, the concept has been restricted, in a medical sense, to health-related QOL. Even though there is no standard concept for the term, there is agreement that a multidimensional construct should be applied, including physical, social, and emotional functioning as well as disease-related symptoms. QOL is not simply symptom assessment. Several other factors influence QOL, and additional domains may be incorporated, depending on the research issues, such as sexual functioning, body image, economic impact, cognition, existential issues, and satisfaction with medical care.[6],[7],[8],[9],[10],[11]

In disease entities, where the alternative therapeutic approaches may vary considerably, it is of paramount importance to incorporate QOL assessment to obtain a comprehensive view of the pros and cons of respective therapies.[12] QOL considerations acknowledge patient autonomy and the right to freely make decisions regarding their medical care and its impact on overall health. Gastroesophageal reflux disease (GERD) represents such a therapeutic area where effective medical therapies have to be compared to surgical alternatives, particularly when the long-term management perspective is taken into account.

QOL may be assessed by the clinician, the spouse, and/or the patient. There are widespread tools created for clinicians, but they only cover, in a global sense, the physical components relevant to QOL assessment.[13],[14] The main reason for not using clinicians or spouses to evaluate the QOL of a patient is, however, the discrepancies found between these ratings and those from the patient. Agreement has thus been reached that the patients themselves are the most reliable sources.

QOL data may be collected by interviews or through questionnaires. The interview may be structured or semi-structured (a combination of open-ended and closed-ended questions). Both methods provide standardization of data collection, but more qualitative information is obtained through the semi-structured interviews. Such interviews are seldom used in a clinical trial because they are time consuming and require extensive resources. The questions for self-assessment are easier to apply to large populations. They are also more reliable tools, because they do not suffer from interviewer bias. During the past decades, several such QOL questionnaires have been developed for use in clinical research. It is important to note that the appropriate QOL instrument is highly dependent on the objectives of the research of interest, and one instrument is not suitable for all applications.