Health Status Versus HRQoL

The first major concern of the IDEA group was a lack of consensus and thus transparency in research of the construct being measured: HRQoL versus health status. Although many investigators use health status and HRQoL interchangeably, others distinguish measures of health status from true QoL instruments. HRQoL refers to domains of health that are important to patients’ QoL and takes into account the patient’s own expectations or internal standards. Health status questionnaires are standardized for “typical patients” and as such, scores provide measures of the effects of disease or treatment, but do not measure the impact of the disease itself or the probability of benefit of treatment to the patient. The term “HRQoL” is also considered problematic by some in that although health impacts QoL, health cannot be equated with QoL. There are those in bad health and good QoL, and vice versa. Additionally, researchers claim that HRQoL implies that QoL can be separated into health and nonhealth, although there is little evidence that patients can make this distinction when reflecting on their own QoL.

Supporting this concern is a review of 75 articles that reported to evaluate HRQoL by Gill and Feinstein. The authors found that only 15% of these papers provided conceptual definitions of HRQoL or health status. HRQoL was often used as a generic label for an assortment of physical functioning and psychosocial variables. Smith and colleagues performed a structural equation analysis of several published papers. Their goal was to determine whether health status (defined by them as “perceived health”) differs from HRQoL. They found that perceived health most strongly related to physical functioning, energy and fatigue, and pain, whereas HRQoL related more to mental health. They concluded that only two domains, mental health and physical functioning, are key determinants of HRQoL judgment. Other domains, such as social support or cognitive functioning, are relevant to HRQoL only to the extent that they affect mental or physical functioning. Implications for HRQoL research from their research are that questionnaires designed to measure health status may be inappropriate for assessing HRQoL. Those measures that do not tap psychologic functioning may be inadequate for monitoring HRQoL.

Streamlining of HRQoL and Health Status Instruments

Another concern from the IDEA group is the multitude of instruments available for particular diseases. The group agreed that some method should be used to evaluate these instruments carefully and that only a few should be used in trials such that the results can be compared and contrasted across studies. One idea was to use an organization, such as the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT). The OMERACT initiative has turned into an international informal network, with a five-member Organizing Committee consisting of members from three continents, and a 15-member Scientific Advisory Committee composed of international opinion leaders from nine countries, all interested in outcome measurement across the spectrum of rheumatology intervention studies. The acronym has been broadened to now stand for “Outcome Measures in Rheumatology.” Others pointed to a recent compilation and evaluation of health status and HRQoL measures, commissioned by the National Institutes of Arthritis, Musculoskeletal and Skin. However, despite the thorough evaluation, there was no recommendation made as to the few measures to use. Moreover, the effort was only one-time and no group, such as the OMERACT, exists to continually evaluate new instruments. The group concluded by recommending a World Wide Web–based initiative, such as OMERACT, to oversee the effort of critiquing and recommending health status and HRQoL measures to be adopted in research.

Minimum Criteria for Dermatologic HRQoL and Health Status Instruments

The next major point of discussion was to articulate a shortlist of minimum criteria to develop and report HRQoL and health status instruments in dermatology. The consensus of ideas includes three major points, listed next. Ideally, a guidance statement, such as the CONSORT for randomized controlled trials or the STROBE for observational studies in epidemiology, would be ideal. However, these statements involve development with editors of major medical journals, none of whom were present at the IDEA meeting.

• 1.
  

  Declaration of domains or constructs that the instrument is to measure so that the distinction of health status versus HRQoL measures can be discerned. At the minimum, a statement of whether health status is being measured or whether a mental functioning component is also included, thus measuring HRQoL.

  
  
• 2.
  

  Psychometric testing of instruments to demonstrate reliability, reproducibility, validity, and responsiveness.

  
  
• 3.
  

  Guidance on clinically relevant difference in scores. The scores on HRQoL or health status instruments would be more useful if there were clinical meaning to either the scores themselves or to a minimum difference in the scores.

Audience for HRQoL Information

The last point that the IDEA group discussed was the target audience for the information gathered from health status and HRQoL measures. Possible users of this information include researchers, pharmaceutical companies, insurance companies, politicians, and patients. Several of the European participants shared their experiences in that their healthcare system has mandated measuring QoL, and encouraged the group to use the existing health status and HRQoL instruments in dermatology and translate such patient-reported outcome measures into quality of care. From a patient care standpoint, several participants point out that dermatologists are not good at detecting depression. HRQoL instruments can help detect signs of depression and start communication between the physician and patient. Because the items that relate to psychosocial issues are imbedded in the instrument, administration of the questionnaire to the patient facilitates initiation of discussion of such awkward issues during the clinic visit.