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PROMIS physical function measures are sensitive enough to detect longitudinal changes due to targeted clinical interventions and able to distinguish among diverse chronic diseases. Patients visiting the Center for Functional Medicine were typically encouraged to schedule follow-up visits every 3 months, as needed, for up to 1 year. Patients without scores at specific time points were excluded from the present study. Secondary outcomes included change in GPH scores from baseline to 12 months, as well as change in GMH scores at 6 months and 12 months.
Descriptive statistics are reported for all patients in the study cohort. Demographics, diagnostic category, and baseline PROMIS GH scores were summarized using frequency count with percentage for categorical variables and mean SD or median with interquartile range for continuous variables, as appropriate. Characteristics were also compared for patients included in and excluded from the study eTable 1 in the Supplement.
Because patients seen in functional medicine differ from those in primary care, propensity score PS matching was used to balance the baseline differences in demographics and other characteristics between the 2 groups. Missing data were imputed under fully conditional specification using the default settings of the Multiple Imputation by Chained Equations, version 2.
A match was performed with nonreplacement and a caliper of 0. Outcomes of patients seen in the Center for Functional Medicine and those seen in the Family Health Center were compared using a paired t test. The proportion of patients who improved GPH or GMH scores by 5 or more points, defining clinically meaningful change, was examined using the McNemar test.
Based on the difference in proportions of patients reaching meaningful improvement, the number needed to treat was calculated. Sensitivity analyses were conducted to explore the association of nonresponse bias. Analyses were conducted as described above within these groups. Statistical analyses were conducted using SAS, version 9.
In total, new patients Family Health Center: and Center for Functional Medicine: were included in the present study Figure 1. Mean SD age of all patients was Table 1 reports the cohort characteristics prior to PS matching. After PS matching, there were patients in each group and there were no differences in any characteristic included in the PS Table 2.
A comparison of patients included in the analyses vs those excluded appears in eTable 1 in the Supplement. Vertical lines represent SEs. To date, the evidence to support the functional medicine model of care has been anecdotal, primarily published as case reports. In this study, the functional medicine model of care was significantly associated with improved longitudinal PROMIS GPH scores in patients at 6 months, and these improvements remained significant for up to 12 months.
However, a more robust sample size and consistent longitudinal tracking of patients are warranted to confirm this finding. The functional medicine model of care also significantly improved short-term PROMIS GMH scores in patients and demonstrated a larger association than care received in a primary care setting; however, long-term improvements were not statistically significant.
Several factors may have contributed to improvements in HRQoL associated with the functional medicine model of care. First, improvements in HRQoL associated with the functional medicine model of care may be due to the model itself. Functional medicine addresses chronic disease by delivering precision medicine. The formal definition of functional medicine was first introduced in and tracks with the more recent precision medicine initiative.
Studies have suggested an association between biological pathways, genes, and molecular markers and quality-of-life domains eg, physical function, fatigue, pain, emotional function, social function, and overall quality of life. Although not inherent to all functional medicine practices, the Center for Functional Medicine requires that all new patients see a registered dietitian and health coach, in addition to a clinician, as part of their initial visit.
Patients also have the option to meet with a behavioral health therapist as part of any visit. In addition, the findings reported herein may not be representative of other functional medicine private practices, because multidisciplinary teams are not ubiquitous.
Second, patients seen in the Center for Functional Medicine may be different from those seeking primary care in a family health center. Our attempt to circumvent this bias was to PS match patients from each center based on certain variables; however, there may be unmeasured confounders associated with the reported outcomes.
For example, patients who request to be seen at the Center for Functional Medicine may be more motivated to make a nutrition-, lifestyle-, or behavior-related change in their life. Success with such change is associated with patient activation measures relating to engagement and self-management opportunities.
Therefore, patients seen in the functional medicine setting may be more engaged and adherent to treatment recommendations. Evidence also suggests that greater patient activation is associated with higher income and more education. In addition, there may be factors contributing to positive healing in patients receiving functional medicine care unrelated to the treatment received, including inherent patient bias toward the efficacy of the model of care, visits in a newer facility or at Cleveland Clinic main campus, or the duration of the initial patient visit.
At the initial visit, patients have 60 to 75 minutes of clinician time compared with a much shorter duration in conventional care. Taken together, all of these considerations may have been associated with possible bias of patient-reported outcomes involved in this study. Third, improvements in HRQoL associated with the functional medicine model of care may be owing to therapeutic partnerships that caregivers build with the patients that empower the patients to be stewards of their health.
The cultivation of a therapeutic partnership between the patient and their caregivers begins at the initial visit, which is substantially longer than an initial visit in a primary care setting. In the functional medicine setting, trained caregivers connect with patients by developing a strong rapport, fostering open communication, and developing a healing language rooted in empathy. Fourth, improvements in HRQoL associated with the functional medicine model of care may be owing to ascertainment bias whereby patients with follow-up at 6 and 12 months may be those improving owing to treatment adherence or belief in the model of care.
Conversely, patients without follow-up may be less adherent or may not believe that functional medicine can help them. It is also possible that patients who did not complete long-term follow-up received benefit from the initial recommendations and felt better. There was no plan for gathering longitudinal data on patients without follow-up. Ultimately, patients without follow-up were excluded from the overall analysis. This bias may not be associated with patients seen at the Family Health Center, because they are receiving routine care or physicals vs study follow-up.
Future studies related to the functional medicine model of care would examine its delivery to determine how it may be associated with proximal eg, patient and clinician satisfaction and treatment adherence and distal eg, symptom burden and total cost of care outcomes.
There are several limitations to this study. First, PS matching of patients on several variables resulted in the loss of eligible patients. However, this step was necessary owing to differences in the patient populations. As a result, generalizations regarding PS-matched Functional Medicine and Family Health Center patients to all patients in those groups should be avoided.
Second, despite various analyses, there were no adjustments for multiple comparisons. The results of our exploratory study are hypothesis generating and focused on magnitudes of differences rather than statistical significance. Further analyses are warranted to evaluate longitudinal outcomes. Published online Oct Michael B. Author information Article notes Copyright and License information Disclaimer.
Corresponding author. Received May 8; Accepted Sep 8. Copyright Beidelschies M et al. Key Points Question Is the functional medicine model of care associated with patient-reported health-related quality of life?
Findings In this cohort study of eligible patients functional medicine center: ; family health center: , functional medicine patients exhibited significantly larger improvements in Patient-Reported Outcome Measurement Information System Global Physical Health at 6 months than propensity-matched patients at a family health center matched pairs.
Meaning The findings of this study suggest that functional medicine may have the ability to improve global health in patients. Abstract Importance The incidence of chronic disease is increasing along with health care—related costs. Design, Setting, and Participants A retrospective cohort study was performed to compare patients aged 18 years or older treated in a functional medicine setting with propensity score PS —matched patients in a primary care setting. Results Of the patients functional medicine center: ; family health center: , Conclusions and Relevance In this study, the functional medicine model of care demonstrated beneficial and sustainable associations with patient-reported HRQoL.
Introduction Chronic disease is challenging health in the United States with nearly million people having 1 or more chronic conditions in Open in a separate window. Figure 1. Statistical Analysis Descriptive statistics are reported for all patients in the study cohort. Table 1. Cohort Characteristics of Patients by Center. Characteristic No. Table 2. Table 3. Figure 2. Discussion To date, the evidence to support the functional medicine model of care has been anecdotal, primarily published as case reports.
Limitations There are several limitations to this study. Notes Supplement. References 1. Multiple Chronic Conditions in the United States. Rising out-of-pocket spending for chronic conditions: a ten-year trend. Health Aff Millwood. Review: health care utilization and costs of elderly persons with multiple chronic conditions. Med Care Res Rev. National health expenditure projections, despite uncertainty, fundamentals primarily drive spending growth.
Nutrition education in an era of global obesity and diabetes: thinking outside the box. Acad Med. Optimizing lifestyle medicine health care delivery through enhanced interdisciplinary education. Your coverage will be effective the first of the month following receipt of application, if received by the 20th of the month.
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