Implementation of Patient Reported Outcomes in
Expensive Intervention Settings of Western-World
Hospitalization: A Systematic Review
Master Thesis Presented to the Faculty of Economics and Business
at the Rijksuniversiteit Groningen
In Partial Fulfillment of the Requirement of the Degree of Master of
Science in Business Administration Specialization Health
Supervisor: Prof. Dr. Maarten J. Postma
Co-Assessor: Prof. Dr. Gerard J. Van Den Berg
Submitted in July 2020 by:
Annabel Magdalena Fabian
Student Number: s4123859
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Abstract
OBJECTIVES: This study addresses the implementation of value-based healthcare (VBHC), focusing
on clinical examples from western countries. A major step in the realization process of VBHC is the development of Patient-Reported Outcome Measures (PROMs) to observe and quantify impacts and outcomes of medical treatments. The aim was to analyze PROM sets developed and used in clinical settings with the intention of investigating the practical feasibility of VBHC.
METHODS: A systematic literature review was conducted by searching through the databases of
EMBASE/MEDLINE and PubMed. We identified 380 publications, of which 20 were included after data-extraction. The articles were categorized according to disease groups (chronic, curable, palliative). All included publications were examined to their PROM sets: type of PROM (generic, disease-, domain-specific), diversification inside the set, collection of PROMs (digital, paper or phone) and the respective intervals. Beyond that, experiences on the implementation of PROMs reported from patients and providers, were specifically identified from the included studies.
RESULTS: The analysis revealed that the underlying PROM sets from our literature were individually
designed, with mostly low PROM diversification inside the set. No indicators were found that providers self-regulate towards transparency. Differences between the sets and inside the groups of chronic and curable diseases were high, so that comparability was hardly given, except for palliative conditions, which all contained domain specific PROMs. Experiences reported by patients and providers showed positive effects, such as greater treatment compliance or higher healthcare satisfaction.
CONCLUSION: Based on this systematic review, it can be concluded that the profound purpose of
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Table of Content
Introduction ... 3
Value-Based Healthcare According to Michael E. Porter ... 3
Patient-Reported Outcomes ... 4
Search Strategy ... 4
Results ... 6
PROM Analysis ... 6
Table 1 PROMs Sets ... 7
Patient Experience and Satisfaction Measures ... 9
Clinical Outcome Measures ... 9
Table 2 Clinical Outcomes ... 10
Implementation Experiences Reported from the Publications ... 10
Discussion ... 11
The Relevance of PROMs ... 11
Implementation Motivation ... 12
Implementation Maturity ... 12
Should Standardization in the Implementation Process be Undertaken? ... 13
Deviation from Porter’s Value-Based Healthcare Approach ... 14
Strengths and Weaknesses ... 15
Conclusion ... 15
Appendix ... 17
Figure 1 Flowchart Systematic Literature Review ... 17
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Introduction
Worldwide, the incidence of chronic diseases is accelerating, affecting people across national borders and socio-economic classes. The most prominent chronic diseases include cardiovascular conditions, chronic obstructive pulmonary disease (COPD) and diabetes mellitus. Further, they are associated with common but preventable risk factors such as hypertension, elevated blood cholesterol levels and obesity. According to The World Health Report 2002 of the World Health Organization (WHO), the remedies to these continuing trends are integrated approaches, as they are considered to be the most cost-effective way to prevent and control chronic diseases in the long term. Through integrated approaches, risks of premature mortality and morbidity should be reduced, as health promotion and cross-disciplinary integration includes the treatment and prevention of secondary and tertiary conditions. Cancer is another disease with a substantial worldwide prevalence. According to the WHO's definition of palliative care, the focus of treatment is on improving Progression Free Survival (PFS) and the Quality of Life (QoL) of the patient. This includes the treatment of pain, fatigue and other health burden associated with the life-threatening condition in order to alleviate them in the best possible way (WHO Definition of Palliative Care, n.d.). Those approaches are highly consistent with what we today call patient-centered healthcare.
Value-Based Healthcare According to Michael E. Porter
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Patient-Reported Outcomes
Patient-Reported Outcomes (PROs) are directly by the patient stated health outcomes. Under PROs Patient-Reported Outcome Measures (PROMs) and Patient-Reported Experience Measures (PREMs) are summarized. The aim of PROM surveys is to improve the quality of care in the long term, as the patient’s view does not only consider medical and technological services, but the individual subjective perception level reporting symptoms, disability levels, functioning, QoL, satisfaction with care and many more. For this the patient himself is the best assessor (Broderick et al., 2013).
PROMs themselves can be divided into different categories. Generic outcomes cover the more general and static aspects and are commonly used to quantify QoL, while disease-specific outcomes describe symptoms individually and more precisely. The target population and the type of disease are decisive in determining which PROMs set suits best. Therefore, if the patient population is predominantly healthy or predominantly comorbid, generic measures like the EQ-5D questionnaire will rather be preferred. When examining patients with a specific diagnosis or a certain or frequent treatment, the use of disease-specific measures is recommended (Cella et al., 2015). The third type of PROMs are domain-disease-specific outcomes, quantifying health attributes such as pain, fatigue, anxiety disorders and many more. Domain-specific measures are detached from disease patterns, thus, they are applicable to make independent comparisons between diseases and clinical conditions (Broderick et al., 2013). Measures such as mortality, survival, readmission rates or hospitalization rates are summarized under clinical outcomes. They are oftentimes automatically generated by hospital information systems. The use of those measures in the PROMs outcome sets will be addressed separately in our analysis. Patient Reported Outcomes Measurement Information Systems (PROMIS) are defined as a mix or hybrid combination of generic and adaptable measures, which tend to be domain-specific measures rather than disease-specific measures (Cella et al., 2015) (National Institue of Health, n.d.).
In this review we will specifically focus on the comprehensive PRO implementation process, the second step of the value agenda (Porter et al., 2009). Our study describes a systematic review about existing value-based healthcare implementation literature in western country clinical settings. The aim of this study is to analyze the patient-reported outcome measures (PROMs) applied in the real-life settings and discuss how those real-life implementation results differ from Porter’s value-agenda and concept of value-based healthcare.
Search Strategy
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Results
In this systematic review we analyzed the PROs of curable, chronic and palliative conditions from the twenty included publications to evaluate the respective underlying structure of PROMs, PREMs and clinical outcome measures. We start with looking at the PROM outcomes and continue in the second section with the patient experience (PREMs) and satisfaction outcomes. In the third section the clinical outcomes are outlined, subsequently reports on implementation experiences were elaborated.
PROM Analysis
The included publications are listed systematically in Table 1. If it was stated in the study, that the quantification of the patient’s QoL was part of the questionnaire, but the generic measurement was not specified, we evaluated this as an unspecified QoL measure. All abbreviations are listed below Table 1. Based on the underlying statistics, it was not possible to make comparisons between the sets, since each publication provides for individualized settings and, for example, determines survey times or patient groups individually. Due to the small sample size we were not able to present statistically valid results but focus on a descriptive presentation of the results. Nevertheless, we were able to determine the following observations for the underlying publications:
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Table 1 PROMs Sets
Author Disease Key
Word Generic Measure Unspecified QoL Measure Domain Specific Measure Disease Specific Measure Curable Conditions
Goretti et al. (2020) Bariatric
surgery
X BAROS
Bernstein et al. (2019) Pain
interference in carpal tunnel release MHQ BCTQ Oemrawsingh et al. (2019)
Ischemic stroke EQ-6D without
the cognitive dimension → transformation
to EQ-5D
mRS
Lam et al. (2018) Minor stroke
and transient ischemic attack RAND-36 PROMIS-Global 10 Score PH MH
Kuklinski et al. (2020) Total knee and
hip replacement
EQ-5D-5L Analogue Pain
Scale PHQ-9 Fatigue
HOOS-PS KOOS-PS
Zipfel et al. (2020) Aortic valve
disease
SF-36
Poulose et al. (2016) Hernia care Pain Intensity
Scale
Bush et al. (2019) Hepatitis C
infection
X WPAI
fatigue
Bernstein et al. (2019) Orthopedic
surgery Physical Function Pain Interference Depression
van Veghel et al. (2020) Coronary artery
disease Individual questionnaire: PROMs, PREMs, patient satisfaction Chronic Conditions
Jørgensen et al. (2018) Inflammatory
arthritis EQ-5D PDQ TRANS-Q MD-HAQ VAS-pain VAS-fatigue van den Hoven et al.
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van Deen et al. (2017) Inflammatory
bowel disease Individual Score Developed Individual Score: Productivity, Disease Control and QoL mHI-CD mHI-UC
Hennink et al. (2013) Lynch
syndrome
VAS Scores Patient
Satisfaction Questionnaire
Friedstat et al. (2017) Burn injury SF-12
SF-36 Vancouver Scar Scale Patient Observer Scar Assessment Scale BSHC BSHC-B Burn Outcome Questionnaire Palliative Conditions
van Egdom et al. (2019) Breast cancer EQ-5D-5L
CarerQoL-7D RCS-NL EORTC-QLQ-Core EORTC-QLQ-BR23 BREAST-Q
Schuler et al. (2017) Cancer care EQ-5D
EORTC QLQ-C30
EORTC QLQ-C30
Lagendijk et al. (2018) Breast cancer EORTC
QLQ-C30 EORTC QLQ-C30 EORTC-QLQ-BR23 BREAST-Q
Parra et al. (2017) Heamodialysis SF-36 modified
Charlson co-morbidity index
VAS Scores
Nguyen et al. (2019) Advanced
non-small cell lung cancer
EORT-QLQ-C30
Quality of death EORT-QLQ-C30
Abbreviations used: Bariatric Analysis and Reporting Outcome System (BAROS), Boston Carpal Tunnel Questionnaire (BCTQ), Burn Specific Health Scale 114-questions (BSHS), Burn Specific Health Scale 40-questions (BSHS-B), Brief Sexual
Symptom Checklist for women (BSSC-W), Care-related Quality of Life (Carer-QoL-7D), Check individual strength (CIS-20), Therapy and Common Terminology Criteria for Adverse Events I-V (CTCEAv4.0), European Organisation for Research and Treatment of Cancer (EORTC), EuroQoL-5 dimensions (EQ-5D), EuroQoL-6 dimensions (EQ-6D), Fertility Quality of Life
(Ferti-QoL9), Female Sexual Distress Scale-Revised (FSFD-R), Female Sexual Functioning Index (FSFI), Hospital Anxiety
and Depression Scale (HADS), Hip disability and Osteoarthritis Outcome Score(HOOS-PS), Knee injury and Osteoarthritis
Outcome Score (KOOS-PS), Multidimensional Health Assessment Questionnaire (MD-HAQ), Mobile Health Index-Crohn’s Disease (mHI-CD), Mobile Health Index-Ulcerative Colitis (mHI-UC), Michigan Health Questionnaire (MHQ), Modified Rankin Scale (mRS), PainDETECT Questionnaire (PDQ), Patient Health Questionnaire (PHQ), Perceived Stress Scale
(PSS-10), Reproductive Concerns Scale (RCS-NL), Short-Form 12 questions (SF-12), Short-Form 36 questions (SF-26 equal to RAND-36), Transition Questionnaire Score (TRANS-Q), Visual-Analogue Scale (VAS), Work Productivity and Activity
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Patient Experience and Satisfaction Measures
Following the principle of value-based healthcare the combination of PROMs, PREMs and clinical measures yields the nominator in the patient value equation. With special regard towards care satisfaction and experience, we analyzed the publications accordingly. The authors Van Veghel et al. (2020) included patient satisfaction questionnaires to determine the quality of medical specialists and hospital performance, in the treatment of cardiac patients diagnosed with coronary artery diseases. In the questionnaire, quality of care delivery, hospital admission, personal contact with the specialist from the patient perspective, as well as the individual value perception were dimensions of interest. Similarly composed patient satisfaction questionnaires were presented by the authors Parra et al. (2017). Their sets concerned haemodialysis patients, measuring treatment satisfaction in thirty-one questions regarding the practitioner (seven questions), the nurses (eight questions), the treatment (eight questions) and the facilities (eight questions). In addition, a VAS-scale was applied to quantify the patient’s individual preferences. These satisfaction scores were weighted and matched with other PROMs, like the modified Charlson co-morbidity index to adjust for the degree of co-morbidity between patients. This was used to compare between the respective haemodialysis facilities. In their study on total hip and knee replacements Kuklinski et al. (2020) examined the effect of PROMs to measure quality of care. Special focus was directed at the early detection of patients in a critical state of recovery and the monitoring of post- surgical regeneration. The study was designed in a Randomized Control Trial (RCT) with patients form nine different clinics included. Next to the PROMs illustrated in Table 1, the authors applied Patient Experience Questionnaires (PEQ) to quantify patient satisfaction. Unfortunately, these questionnaires are not publicly available. A further example we give comes from Bernstein et al. (2019). The authors attempted to provide evidence on whether patients in routine orthopedic care perceived a better treatment experience if PROMIS were implemented into their care pathway. For this, they used the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CGCAHPS) survey, a validated experience questionnaire.
Clinical Outcome Measures
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Table 2 Clinical Outcomes
Implementation Experiences Reported from the Publications
Reported experiences or feedback from providers and patients on the implemented VBHC outcome sets are particularly valuable regarding improvements of future implementation processes. Therefore, the included publications were closely examined regarding, how the PROM sets affect patients and how providers put patient participation into practice.
For curable conditions like in the example of bariatric surgery Goretti et al. (2020) reported about increased patient adherence after care path redesign along the principles of the value agenda towards value-based healthcare delivery. Through the development towards an Integrated Practice Unit (IPU) treatment costs were reduced. Through these funds further motivational activities were offered for the patients, like counseling or creation of a personal diary. Providers observed higher adherence among their patients and better overall treatment results. The authors Bernstein et al. (2019) set up a study to test the impact on patient experience under the use of PROMIS for a patient population undergoing orthopedic surgery. Direct comparison between treatment and control group showed, even though not significant, that the patients who completed PROMIS questionnaires in the waiting room before the appointment with the surgeon reported afterwards higher treatment satisfaction. Patients reported that treatment information was better explained to them and that the provider spend sufficient time with them. Moreover, patients reported that they would recommend the provider to other patients and at the same time rated providers higher. In the group of chronic conditions, the authors Hennink et al. (2013) faced a general compliance problems among their patients with Lynch Syndrome. The authors anticipated this hindrance by specially addressing compliance during the treatment process. Changes in compliance were monitored in intervals of 6 years, with the aim to reach a compliance rate of over 95%. Looking at the palliative conditions, the authors van Egdom et al. (2019) who studied their value-based healthcare implementation process for breast cancer care, also received positive feedback on their PROMs sets. Patients reported that by completing the questionnaires they gained greater awareness of
Condition Clinical Outcomes
Curable 30-days mortality, 120-days mortality, 3-months mortality, 1-year mortality, survival, morbidity,
comorbidity, symptom scores (fatigue, nausea, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties), post-operative complications, post-operative revision, readmission, 30-days readmission, 30-days re-operation, re-operation, early recurrence, free of intervention, surgical site occurrence rate, surgical site infection rate requiring reoperation, pain, cerebrovascular accident within 72h, deep sternal wound infection within 30-days, myocardial infarction within 30-days, event free survival, excess weight loss at 1 and 3 years
Chronic Mortality, morbidity
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their own functioning and supported them in their cancer treatment. Similar results were reported in the study by Lagendijk et al. (2018). Particularly good insights were gained into patient satisfaction and acceptability of PROMs questionnaires by adding three dedicated questions to the end of the questionnaire. The evaluation revealed that almost all patients reacted positively to those questions, meaning that improvement for care, self-reflection and acceptability towards the PROMs sets was high among the respective patient group. Those real-life implementation examples and positive outcomes of approaches towards outcome and patient value measurements should therefore motivate for further implementation of all types of PROMs sets in practice, which we will discuss in the following section.
Discussion
From our systematic literature search we included twenty publications, which we categorized according to curable, chronic and palliative conditions. PROs in general are prominent and frequently mentioned in the implementation literature, but rather addressing treatment outcomes (PROMs) than patient experience (PREMs). We found that curable and chronic PROM sets are difficult to compare because of the heterogenous compositions. On the contrary, the cancer sets in the group of palliative conditions showed higher comparability through the implementation of EORTC questionnaires. We attribute this to the fact that cancer is one of the first diseases for which standardized sets were designed and conclude that these PROM sets have already been studied the longest. We provide arguments for a general standardization effort to achieve uniform implementation results for the three condition groups in the long run. This raises the question of common responsibility, which brings us to the International Consortium of Health Outcomes Measurements (ICHOM) and its current mission and role. Our study could be helpful to determine the deviations from Porter’s value-based healthcare approach and the real-life implementation examples we encountered in the included publications.
The Relevance of PROMs
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project. Since the lack of comparability between metrics is a known problem, the PROSetta stone project elaborated a method to interconnect PROMIS with generic sets (Choi et al., 2012). Such efforts are in our opinion essential in the future, as large-scale standardization efforts of the underlying statistics will considerably improve the validity and relevance of the data collected.
At first, the results of the clinical outcome measures appeared outstanding in our analysis, as it might not seem logical why operational outcomes like e.g. readmission rates should not be measured regardless of the underlying condition. On second thought, however, the goal of curable care is to help patients recover as fast as possible, which puts pressure on organizational and operative structures. From this point clinical and operative measures are by therefore not suitable for performance determination for chronic diseases, as chronic disease management includes and requires long-period monitoring of the patient. Since palliative sets are generally better diversified, the clinical measures also seem appropriate in this context.
Implementation Motivation
Economic incentives are mentioned when it comes to the context of PROM implementation, even if Porter highlighted that the motivation behind the concept of value-based healthcare is always the monitoring of well-being and value for patients. During ongoing studies, it may happen that the questionnaires are more extensive for research reasons and patients are made aware of this beforehand. An example would be that PROM sets contain PROMIS and EQ-5D questionnaires, both generic measures to quantify QoL. PROMIS are patient-friendly questionnaires, but rather unwieldy for research purposes. EQ-5D questionnaires in contrary are easier to evaluate and are therefore frequently applied in research. Both in PROMIS and EQ-5D questionnaires, the patient could possibly be confronted with the same questions twice. Research situations represent an exceptional situation, but in broad practical implementation care should be taken to avoid such duplication, as it can be perceived incomprehensive to the patient and can lead to compliance issues, lowering the willingness to answer the questionnaires accurately. Even if patient satisfaction and patient value are occasionally part of the discussion points, an intensified reflection on the impact, outcomes achieved and costs, (i.e. the components of value equation) is still necessary and currently missing. This would help clarifying motivational aspect of implementation and further open a broader picture of value-based healthcare implementation, as we cannot identify that all three aspects of the value-equation are discussed in one study. Equal observations were reported by the authors Kampstra et al. (2018).
Implementation Maturity
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are underlying. We consider the setting to be advanced at a point when patients can fill out the questionnaires digitally, for example, using a tablet in the waiting room. A possible solution for this is described in the publication by Goretti et al. (2020). The authors report that patients continue to visit the clinic for follow-up consultations after bariatric surgery. PROMs were collected digitally and during follow-up, allowing them to measure long-term treatment outcomes. Adding to that, an entire value-based healthcare implementation process towards an IPU is described by the authors. In this context, the reduced costs in the care process were used to finance motivational activities for the patients. We consider this cultural restructuring together with the progressive implementation of the PROM sets as elaborated implementation example. Another example we want to point out comes from the authors Bernstein et al. (2019). As previously explained, the aim of their study was to examine the effect on patient experience when patients fill out a PROMIS questionnaire before consultation with the physician. The digital collection of data through a tablet allowed that the PROMIS answers were transferred directly to the patient's Electronic Health Record (EHR). Further, the answers were combined with the results of the CGCAHPS questionnaires for each patient, collected during the same time frame, which resulted in a broad overview. What we consider very advanced in this, is that data was collected on how long the provider was checking the patient’s questionnaire results. Unfortunately, in this regard no further data was published. Nevertheless, we are convinced that this is the best interest of patients and in line with the value-based healthcare approach. An important result of our analysis was that the cancer sets showed a higher degree of comparability in comparison, as all sets contained EORTC questionnaires that were specially developed for cancer patients. With these examples, we can underline how different approaches from practice are implemented in value-based healthcare, leading to the question of whether standardized procedures would facilitate the process and lead to a more uniform implementation.
Should Standardization in the Implementation Process be Undertaken?
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more the focus of interest due to the sharp rise in disease rates. Clearly, since cancer treatment is one of the most expensive treatments and the success of the therapy determines life or death, it can be assumed that in this field treatment effects are more closely monitored. Since healthcare systems vary greatly across countries, it is questionable whether PROM sets should really be developed on an international level. After all, an international set cannot be implemented uncompromisingly in a health care system or patient group, but individual adaptations need to be undertaken by providers. This however leads to the current situation in which sets being changed in such a way that they can no longer be compared. Furthermore, countries differ greatly in terms of size, organization, and structure of the healthcare system, so that it appears reasonable for each country to develop its own PROM sets and respective implementation roadmap. The smaller and more heterogeneous a country is organized, the easier it will be to implement standard sets. Increasing size and federalized structures (i.e. increased heterogeneity), will make implementation more challenging. We therefore believe that it would be better to develop country specific sets that are then applied regionwide or ideally nationwide. This would ensure an individual adaptation to the respective healthcare system, anticipating the system’s key debates to develop sets which are widely feasible. Since treatment programs, medications and therapy options are constantly undergoing further development and improvement, PRO sets are not static either but need to be regularly revised and adapted to the status quo. Therefore, an overarching organization, evaluating and recommending validated and experience-based elements to include in PRO sets, would ensure that PRO sets do not become outdated and that patient value permanently takes on the central role.
Deviation from Porter’s Value-Based Healthcare Approach
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Strengths and Weaknesses
Our systematic review shows both strengths and weaknesses. Since the literature in the field of value-based healthcare implementations is still relatively new, we adapted our search strategy by means of an extensive literature screening process. Although we excluded some disease areas in advance, our final set of 20 included publications covers a broad spectrum of diseases. Since we did not determine any disease-specific inclusion criteria, the resulting disease spectrum is a randomized outcome, which we consider as a strength. But our systematic review also shows some inherent limitations. In our review, we solely analyzed western- world implementation examples, i.e. countries that generally have advanced healthcare systems, which can cause potential selection biases. Unfortunately, we could not ensure that examples of implementation from all western countries were represented. In addition, the fact that we focused on hospital implementation examples also implies a limitation, as VBHC must be implemented not only in hospital settings but across all care units to achieve great success. This implies also potential for a selective bias, since hospitals are bundling considerably more research resources and know-how compared to primary and secondary care pathways and therefore it is likely that implementation is therefore more advanced, but this requires further research on the status quo of the VBHC implementation in primary and secondary care provision. Due to the very heterogeneous types of publications, their respective patient groups, and the underlying statistics, it was difficult to present detailed results of the included studies in a generalized way. We encountered that the underlying questionnaires and PROM sets were described with varying degrees of clarity, significantly complicating the analysis process. Therefore, minor deviations might be possible.
Conclusion
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Appendix
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