Assessment of patient-centered outcomes (PROs) in inflammatory bowel disease (IBD): a multicenter survey preceding a cross-disciplinary (functional) consensus

Inflammatory bowel disease (IBD), comprising Crohn’s disease (CD), ulcerative colitis (UC) and IBD unclassified (IBD-U), is a chronic immune disease that frequently emerge early in life and requires chronic health care. The wide spectrum of IBD disease severity and frequency of complication occurrence impair patient physical and mental health, quality of life (QoL), and social functioning, resulting in the need for chronic intensive disease monitoring, regular outpatient appointments, hospitalization, and surgery [1]. The prevalence of IBD is increasing globally, with the incidence rising particularly rapidly in Asia [1], accompanied by increasing rates of hospitalization, cumulative surgery, reoperation, and permanent work disability [2, 3]. All these lead to high costs to patients and the healthcare system [4]. Quality of care (QoC) is defined as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge” [5]; subsequently, the provision of advanced QoC reduces the per capita costs of healthcare [6]. In some studies, QoC was related to both healthcare provider use of technology and interpersonal skills, which depend greatly on the quality of their communication with patients [7, 8]. The evaluation of QoC consists of the quality of the services provided and patient perception of services received. There is always a gap between physician and patient perception of QoC [6, 9, 10].

Healthcare is transitioning towards a value-based system [11, 12]. The acceleration of outcome measurement can unlock the potential of value-based healthcare in driving improvements [13]. Alongside traditional biomedical measures, patient-centered outcome measures are increasingly being used for the evaluation of the management and treatment of different diseases [14‐18]. Efforts should be driven towards the application of the patient-centered outcome (PRO) measures in chronic conditions, as the major goals of management are the reversal of disease progression or its arrest, and QoL improvements. Considering the global burden of IBD and its wide-ranging effects on QoL, several attempts have been made aimed at the development of patient-assessed health outcome measures [19]. However, patient-reported outcomes other than those pertaining to disease-related symptoms or QoL are rarely captured in IBD care settings. Therefore, this study was performed with the establishment of the “Standard Set of Patient-centered Outcomes for Inflammatory Bowel Disease – an International, Cross-disciplinary Consensus” as the background survey for the enhancement of actuality basis.

The aims of this study were to assess patient-centered outcomes, including patient perception of QoC, and investigate whether patient-reported outcomes are associated with demographic factors and clinical status. Subsequently, the differences between patient and physician perception of QoC were also determined.

In this study, we found that both patients and physicians perceived the IBD-related QoC as being satisfactory. Furthermore, we uncovered shortcomings according to the patient perception. Female sex and the presence of certain negatively impacting disease characteristics were associated with lower satisfaction levels.

The importance of the systematic tracking and reporting of patient-centered outcomes is gradually being realized. Through the comparison of meaningful patient outcomes, providers can adopt strategies aimed atachieving the best “value” for participating stakeholders; this is defined as value-driven care [19]. The present study was devoted to the pursuit of this aim. When the provision of care is driven by outcomes, remission rates go up [20]. The US Food and Drug Administration (FDA) has advocated the routine inclusion of patient-reported outcomes as co-primary endpoints in clinical trials [21]. Although QoL improvement is a commonly used secondary endpoint in clinical trials, it was the primary endpoint in only one trial focusing on IBD [22] and is rarely captured in routine practice.

In this study, 61.7% of the patients with CD and 41% of those with UC experienced anxiety or depression due to IBD in the 2 weeks preceding questionnaire administration. Unemployment and taking long-term sick leave due to IBD ranked the highest in terms of the causes of anxiety and depression, compared to other current occupations. A previous study showed that absence from work and the presence of active disease were the two main factors associated with a reduced health-related QoL (HRQoL) [23]. Another study proved that absence from work, number of physician visits, and the proportion of procedures undergone were related to an impaired HRQoL [24]. Thus, a greater degree of attention should be paid to those with unemployment and long-term sick leave. Previous studies have shown that IBD is associated with a high prevalence of anxiety and depression. Psychological therapies and cognitive behavioral therapy may be beneficial in decreasing the levels of anxiety and depression in IBD [25‐27].

None of the patients consulted family doctor. It should be mentioned that there are very few family doctors or general practitioners in China, and that most patients consult specialists.

There has been a tendency for patient perception of the quality of healthcare to be ignored as they are not adequately aware of what constitutes high care quality. As of 2018, no consensus on patient satisfaction or Quality of Care (QoC) measurement had been reached [28]. Previous studies focusing on patient satisfaction with IBD care presented conflicting results in terms of the factors that affect their QoC-related perception [29‐31]. A judgment of low quality may have resulted as a consequence of extremely high expectations or the provision of a very poor QoC [32]. In addition, it cannot be directly concluded that the conflicting results reflects the diversity of various care centers and geographical location, since this could be explained by methodological differences or bias caused by the selection of participants. In this multicenter study, only 5% of the patients with CD and 3.9% of those with UC, and 0% of the physicians stated that they were dissatisfied with the quality of IBD care, consistent with previous studies [33]. Therefore, the patients with IBD were satisfied with the QoC provided in the included hospitals. Since each investigated hospital has an IBD care center consisting of an IBD-specialized inpatient and outpatient department and a multidisciplinary team, these measures are inferred to be essential for the improvement of the level of satisfaction with the quality of IBD care. A previous study has shown that even hospitals with a minimal IBD service performed better in terms of many process and outcome measures. Hospitals with a partial IBD service showed a greater degree of adherence to the standards for safety monitoring of biologic (89% vs. 59%) and immunosuppressive drugs (79% vs. 55%), and a rate of admission via an emergency department that was 22% lower than that in hospitals without such a service [34]. Furthermore, the introduction of an IBD nurse is also essential, which leads to significant cost savings and better QoC, through the reallocation of physician time resources and reductions in the hospitalization rates [35]. As is well-known, the incidence of IBD has increased rapidly in Asia in recent years, especially in countries undergoing rapid industrialization [36, 37]. Our data on the IBD-related QoC may aid local governments in more effectively allocating resources for accelerating the construction of specialized and dedicated IBD care centers [38].

In our study, patient satisfaction with the quality of IBD care was related to the satisfaction with the level of communication with specialists. Patient-physician communication is vital in ensuring patient commitment and involvement in long-term disease self-management [38], and influences complementary and alternative therapies [39]. In medical care, communication is highly associated with better patient adherence to doctor’s advice [40]. However, no significant differences were observed between the CD and UC groups in the level of satisfaction with the quality of IBD care received in the past 12 months. Female patients regarded the quality of IBD care as being worse than male patients. This can be attributed to several factors. A large population-based cohort showed no significant differences in terms of HRQoL between patients with UC and those with CD, overall, whereas a significant reduction in HRQoL was observed in women but not in men compared to the background population [23]. Female patients with IBD show a larger number of intense concerns, a greater level of psychological disturbance, a higher symptom load, and a poorer QoL than men, resulting in reduced satisfaction ratings [41‐44]. A lower level of satisfaction amongst female patients was also noted in the QUOTE-IBD studies [45, 46]. Moreover, the finding that indicates a lower level of satisfaction amongst women is consistent with those of many other patient satisfaction-related studies [47, 48]. Secondly, no statistically significant difference was observed between the CD and UC groups in the assessment of the level of communication with health specialists in the past 12 months; however, a greater number of female than male patients assessed the level of communication as being worse. This finding suggests that, in the formulation of an appropriate communication strategy and provision of information about the disease, one should take into account subjective perceptions of QoL and sex-related differences [49]. In terms of the influence of demographic and clinical data on the level of satisfaction with the quality of IBD care in the current study, female patients, patients with significant pain or discomfort, those who felt a lack of energy or were fatigued for the majority of the time, and patients who experienced anxiety or depression in the 2 weeks preceding questionnaire administration were found to be less satisfied with the quality of IBD care than their counterparts. Similarly, a previous study also showed that anxiety-related symptoms were determinants of patient satisfaction among youths/adolescents with IBD [50]. In our study, no major differences related to the patient-perceived QoC was noted when stratification was performed according to disease subtype, age, disease duration, education level or abdominal surgery history. Nonetheless, a previous study showed that older age was associated with modestly higher scores on the Short Inflammatory Bowel Disease Questionnaire and mental HRQoL, but a lower physical HRQoL score [51]. Another study using PROMIS instruments showed that patients with CD had a significantly worse degree of impairment than those with UC in a population of ambulatory adults [49]. However, a prospective study conducted in a high-volume IBD center proved that perceived QoC is associated with sex, disease activity, work productivity and QoL, but not disease phenotype [52].

The bias and difference between specialists and patients requires investigation. Specialists should strive to improve the quality of doctor-patient communication. The differences in the scoring trends between physicians and patients could be related to the generally insufficient communication status due to high inpatient and outpatient department volumes and relative scarcity of healthcare providers, as well as the higher expectations of patients receiving IBD care at centers in first-tier cities. Furthermore, half of the patients considered the consultation time to be insufficient. Moreover, only two-thirds of the patients had a regular IBD review appointment regardless of the IBD activity status. Most patients were used to seeking specialist advice during a flare-up at hospitals or clinics; few received advice through telephone or email. The government should allocate a larger volume of funds aimed at improving the doctor-to-patient ratio to ensure better communication between physicians and patients.

Furthermore, in this era of growing healthcare cost constraints, providers must also demonstrate a favorable cost:benefit ratio with patient-centered outcome-based intervention; this requires further evaluation beyond the scope of this study. However, making improvements to some of the patient-centered outcomes (for instance, those items related to communication, information, consultation topics, and staff availability) may only result in small or negligible costs.

This study has some limitations. Firstly, the participants were enrolled from care centers across the eastern parts of mainland China, and may not be representative of the entire Chinese IBD population. The regions included in our study are more developed and industrialized than other parts of China. Secondly, the current study had a cross-sectional observational design. We cannot infer causality from these results, although it was possible to identify measures for improvements in clinical practice and patient care. Last, but not least, this study included a high number of statistical tests, which may result in type I errors. Despite these limitations, the current study provides important insights into the factors associated with patient-centered outcomes, as well as broadens the scope of the discussion pertaining to the status of IBD care in China.

In conclusion, we found that both patients and physicians perceived the IBD-related QoC as being satisfactory. We also identified areas of shortcomings and improvement where it comes to patient perception, and established that female sex and the presence of certain negatively impacting disease characteristics were associated with lower satisfaction levels. Therefore, patient concerns pertaining to their disease must be reassessed regularly, since there are certain aspects of IBD-care that may be improved, as evident from this study.