Background Applying disease-specific guidelines to people with multimorbidity may result in complex regimens that impose treatment burden. Objectives To describe and validate a measure of health care treatment difficulty (HCTD) in a sample of older adults with multimorbidity. Research Design Cross-sectional and longitudinal secondary data analysis Subjects Multimorbid adults ages ≥65 from primary care clinics Measures We generated a scale (0–16) of self-reported difficulty with 8 health care tasks(HCTD) and conducted factor analysis to assess its dimensionality and internal consistency. To assess predictive ability, cross-sectional associations of HCTD and number of chronic diseases, and conditions that add to health status complexity (falls, visual, and hearing impairment), patient activation, patient-reported quality of chronic illness care (Patient Assessment of Chronic Illness Care; PACIC), mental and physical health (SF-36) were tested using statistical tests for trend (n=904). Longitudinal analyses of the effects of change in HCTD on changes in the outcomes were conducted among a subset (n=370) with≥1 follow-up at 6 and/or 18 months. All models were adjusted for age, education, sex, race and time. Results Greater HCTD was associated with worse mental and physical health (Cuzick’s test for trend (P<0.05), and patient-reported quality of chronic illness care (P<0.05). In longitudinal analysis, increasing patient activation was associated with declining HCTD over time (P<0.01). Increasing HCTD over time was associated with declining mental (P<0.001) and physical health (P=0.001) and patient-reported quality of chronic illness care (P<0.05). Conclusions The findings of this study establish the construct validity of the HCTD scale.

Real-world research can use observational or clinical trial designs, in both cases putting emphasis on high external validity, to complement the classical efficacy randomized controlled trials (RCTs) with high internal validity. Real-world research is made necessary by the variety of factors that can play an important a role in modulating effectiveness in real life but are often tightly controlled in RCTs, such as comorbidities and concomitant treatments, adherence, inhalation technique, access to care, strength of doctor-caregiver communication, and socio-economic and other organizational factors. Real-world studies belong to two main categories: pragmatic trials and observational studies, which can be prospective or retrospective. Focusing on comparative database observational studies, the process aimed at ensuring high-quality research can be divided into three parts: preparation of research, analyses and reporting, and discussion of results. Key points include a priori planning of data collection and analyses, identification of appropriate database(s), proper outcomes definition, study registration with commitment to publish, bias minimization through matching and adjustment processes accounting for potential confounders, and sensitivity analyses testing the robustness of results. When these conditions are met, observational database studies can reach a sufficient level of evidence to help create guidelines (i.e., clinical and regulatory decision-making).

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