Degree of coincidence of the change in health-related quality of life in the recovery-phase rehabilitation ward and the proxy’s response: Evaluation of patients with musculoskeletal disorder by EQ-5D-5L

doi:10.21203/rs.3.rs-5003305/v1

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Research Article

Degree of coincidence of the change in health-related quality of life in the recovery-phase rehabilitation ward and the proxy’s response: Evaluation of patients with musculoskeletal disorder by EQ-5D-5L

https://doi.org/10.21203/rs.3.rs-5003305/v1

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Background

Recently, a conversion table of the EuroQol 5-dimension 5-level (EQ-5D-5L) unique to Japan was created that facilitates the measurement of the health-related quality of life (HRQOL) of a participant. Currently, however, only a few investigations have been conducted of HRQOL using the EQ-5D-5L in the recovery-phase rehabilitation ward. Moreover, proxy responses for patients who are unable to respond for themselves have only been reported for stroke patients.

Methods

In this study, we used the EQ-5D-5L to investigate changes in HRQOL before and after rehabilitation and the degree of agreement between the patient’s responses and the occupational therapist’s proxy responses in patients with musculoskeletal disorders who were hospitalized in a recovery-phase rehabilitation ward.

Results

Among the 77 participants, HRQOL was improved after rehabilitation, and the effect size was large (self response; SRM = 0.90, proxy response; SRM = 0.95). Regarding the degree of agreement between the QOL values, the intraclass correlation coefficient was 0.68 for the initial evaluation and 0.72 for the re-evaluation, indicating substantial agreement.

Conclusions

The results of this study showed that the EQ-5D-5L was responsive as an indicator of outcome of patients with musculoskeletal disorders who were hospitalized in a recovery-phase rehabilitation ward and that proxy responses by occupational therapists can measure QOL values similar to those of the individuals themselves.

Health-related quality of life

responsiveness

inter-rater reliability

recovery-phase rehabilitation ward

motor disorder

EQ-5D-5L

In recent years, studies on health-related quality of life (HRQOL) as an outcome have begun to appear in the field of rehabilitation. This is thought to be because the number of people living with chronic disabilities has increased, and the scope of medical practice has expanded from acute to chronic diseases [1]. In other words, although we cannot expect marked improvement of physical functions due to illness, it is necessary to show whether the participant’s life has improved through various approaches, including rehabilitation. Additionally, HRQOL is based on patient-reported outcomes (PRO), which can comprehensively measure the impact of the approaches to psychosomatic functions, activities, and participation in rehabilitation on the patient’s levels of happiness and satisfaction.

However, the ADL scale is used as the main outcome for determining the effectiveness of rehabilitation in Japan. This is considered to be a valid assessment because of the high responsiveness of the ADL scale in recovery-phase rehabilitation ward, which aim to improve self-care. On the other hand, a ceiling effect of the ADL scale (15.7%) [2] has been reported, so it is necessary to determine the effectiveness of measures other than ADL, and it is necessary to investigate the responsiveness of the quality of life scale. Li et al. [3] investigated the responsiveness of the EQ-5D-5L in the Fracture Liaison Service for orthopaedic diseases and found moderate responsiveness. Bilbao et al. [4] also reported greater responsiveness of the EQ-5D-5L before and after surgery for hip and knee joint disease. However, there have been no reports of responsiveness using the EQ-5D-5L before and after rehabilitation in orthopaedic diseases, not even in studies on orthopaedic diseases in Japan.

In addition, because PRO are measured by patients themselves, they are difficult to measure in participants who have difficulty in responding by themselves (e.g., those with dementia, aphasia, higher brain dysfunction, etc.). As a solution to this problem, previous studies have investigated QOL evaluated by doctors, nurses, and family members acting as a proxy, but the degree of agreement is reported to be low [5, 6, 7]. Those previous studies expressed agreement as inter-rater reliability, with the intra-class correlation coefficient indicating the degree of agreement.

However, a previous study in Japan [8] revealed that for stroke patients in a recovery-phase rehabilitation ward, the degree of agreement between the patient’s self-response and the response by the proxy occupational therapist (OT) using the EuroQol 5-dimension 5-level (EQ-5D-5L) tool was high. Outside Japan, there are some reports on the use of this scale, the EQ-5D-5L, but there are few reports in Japan, and the investigations of the patients with musculoskeletal disorders in recovery-phase rehabilitation wards have only been performed with the EuroQol 5-dimension 3-level (EQ-5D-3L) [9]. Therefore, we considered it necessary to conduct a longitudinal study of the EQ-5D-5L scale of HRQOL to show changes in HRQOL and to clarify the degree of agreement between the participant’s self-responses and those of the proxy OT.

The following two effects are expected from this study. First, because this is a longitudinal study, changes in HRQOL before and after rehabilitation can be clarified, thus making possible an approach based on the impact of rehabilitation and its results. Second, if the degree of agreement between the participant’s response and the proxy’s response is high, even if the participant cannot respond by oneself about their HRQOL, an approximate idea of the participant’s HRQOL can be estimated, therefore making it possible to prepare a rehabilitation plan based on the HRQOL of the participant. If the degree of agreement is low, however, this infers that a plan can be established based on the results of analysis of the degree of agreement of each item.

Among the many HRQOL scales available, the EQ-5D-5L is used for the following three reasons. First, because the questionnaire consists of 5 items with 5 choices, it can be answered in as short as about 5 minutes, thus reducing the burden on the participant and evaluator. Second, as there is a self-response version and a proxy response version, a third person can respond for a participant who has difficulty responding by oneself. Third, although this scale was prepared outside Japan, scoring unique to Japan has been prepared [10], thus allowing measurement of HRQOL appropriate to Japan. Moreover, HRQOL can be compared among countries, and the characteristics in each country can be understood.

Further, the EQ-5D has been used as a measure of the cost-effectiveness of medical technology implemented in other countries, and the use of the EQ-5D in Japan has been recommended in discussions about the evaluation of medical technology [11]. Therefore, the investigation of the EQ-5D-5L scale is considered essential for future evaluations of the medical economics of rehabilitation.

Objectives

The objectives of this study were to clarify the change in HRQOL of patients with musculoskeletal disorders who were hospitalized in a recovery-phase rehabilitation ward and to investigate the degree of agreement between the participant’s own response and the proxy’s responses. Specifically, the following two points were investigated:

1. Investigation of the change in HRQOL before and after rehabilitation using the EQ-5D-5L scale.

2. Investigation of the degree of agreement between the participant’s response and the proxy’s response to the EQ-5D-5L scale of HRQOL and clarification of the characteristics of the proxy’s response. However, as the basis is the participant’s response, the participants who can respond by themselves are targeted in this study.

Study design and participants

The study design was that of a multicenter collaborative longitudinal study that included a total of five institutions in Japan to minimize regional and hospital biases. To determine the sample size, the most stringent criteria were set according to the method of Doros and Lew [12]. The criteria indicated that the number of participants should be set at more than 50, so to account for an expected data loss of 20%, 10 participants were added to the 55 participants, resulting in a minimum sample size of 65 participants. The survey period was from March 2020 to October 2022, and the evaluation periods were within 1 week after entering the recovery-phase rehabilitation ward (initial evaluation) and 1 month later (re-evaluation). In setting the timing of re-evaluation, because the hospitalization period of the patients with musculoskeletal disorders varies [13], and to express changes in QOL values over the same hospitalization period, the timing was unified to 1 month later.

The participants were patients with musculoskeletal disorders who were hospitalized in the recovery-phase rehabilitation ward (the treatment fee for musculoskeletal rehabilitation was calculated based on the rehabilitation classification by disease), and the exclusion criteria were patients with disturbance of consciousness, aphasia, higher brain dysfunction and cognitive impairment (based on a Mini Mental State Examination [MMSE] score of 19 points or less), and who had difficulty in responding by themselves. The recovery-phase rehabilitation ward is defined as a ward in which many specialists team up to provide intensive rehabilitation for patients recovering from the acute phase of cerebrovascular disease or femoral neck fracture who still require medical/social/psychological support with the aim of returning them to home or society in a physically and mentally recovered condition [14].

The EQ-5D-5L was used to measure HRQOL at the same time by the participant and proxy in the order of proxy’s response and participant’s response so that the proxy would not know the participant’s response. Participants were also similarly kept unaware of the proxy's responses. The participant entered responses into the evaluation form by oneself, and if the participant had a visual disturbance or hearing disorder, the proxy therapist was allowed to assist the participant. The proxy was an OT in clinical practice who showed a high degree of agreement in a previous study [8].

EQ-5D-5L scale

HRQOL was measured using the EQ-5D-5L, which evaluates 5 subitems, “mobility,” “self-care,” “usual activities,” “pain/discomfort,” and “anxiety/depression” in 5 grades. A conversion table unique to Japan was used to convert QOL values [10]. The QOL values range from 1.00 (perfect health) to -0.025. In addition, the MMSE and Functional Independence Measure (FIM) were used for evaluation of cognitive function and ADL, respectively, in the participants.

Statistical method and ethical procedures

As statistical methods, Wilcoxon’s signed rank test was used for the comparison of each scale before and after rehabilitation, and the effect size was calculated by the standardized response mean (SRM): \(\:\text{S}\text{R}\text{M}=\frac{{\stackrel{-}{X}}_{Time2}-{\stackrel{-}{X}}_{Time1}}{{SD}_{Difference}}\) [15]. SRM was used as the criterion for responsiveness. SRM is obtained by dividing the mean change in the initial evaluation and reevaluation values by the standard deviation (SD) of the difference score. For the effect size, < 0.5 indicates a “small effect,” 0.50–0.80 a “medium effect,” and > 0.80 a “large effect.” Based on previous studies in Japan [8], we predicted a medium level of responsiveness (SRM=0.785 ((0.65 (self response) + 0.92 (proxy response))/2)).

Inter-rater reliability was defined as agreement, with the ICC indicating the degree of agreement. Regarding the degree of agreement between the participant’s response and proxy’s response, the participant’s response was used as the external criterion, the intraclass correlation coefficient (ICC) was used for the QOL value, and the weighing factor κ was used for selection of each level of the sub-items, with coefficients of 0.00 to 0.20 considered as slight agreement, 0.21 to 0.40 as fair agreement, 0.41 to 0.60 as moderate agreement, 0.61 to 0.80 as substantial agreement, and 0.81 to 1.00 as almost complete agreement [15]. And based on the COSIMIN criteria, ICC ≥ 0.70 was defined as a good measurement properties [16]. For weighting, we used the second-order weighting recommended by Fayers and Machin [17]. IBM SPSS Statistics 24 was used for these analyses, and the level of significance was set as 5%.

In conducting this study, ethical consideration were made in accordance with the “Ethical Guidelines for Medical Research in Humans” [18] and declaration of Helsinki. Moreover, written informed consent was obtained from the participants of this study, and this study was approved by the ethical review board of our university (approval no.: 16045). And as it is not a clinical trial, the clinical trial number is not applicable.

Among the 80 candidates, 77 participants without missing data were included. Their mean age was 77.7 years old, the mean period from the day of onset to initial evaluation was 12.2 days, and that from initial evaluation to reevaluation was 31.9 days. There were 57 females and 20 males, and the diagnosis was hip fracture in 35 participants, osteoarthritis in 7 participants, vertebral fracture in 10 participants, and others in 25 participants (Table 1).

Table 1

Characteristics of the participants (n = 77)
Characteristic	Value
Age (years), mean (SD)	77.7 (12.7)
From date of admission to initial evaluation (days), mean (SD)	12.2 (12.4)
Rehabilitation terms (days), mean (SD)	31.9 (14.3)
Sex (n)
Female	57
Male	20
Diagnosis (n)
Hip fracture	35
Osteoarthritis	7
Vertebral fracture	10
Other	25
SD standard deviation

Comparison before and after rehabilitation showed significant improvement in all items. Although the effect size was inferior to that of the FIM, the QOL value was 0.90 for participant’s response and 0.95 for the proxy’s response, indicating a large effect (Table 2).

Table 2

Changes in outcome measures
Item	Initial evaluation	Re-evaluation	p value	SRM
Item	Mean (SD)	Mean (SD)	p value	SRM
MMSE (points)	26.0 (4.7)	27.1 (4.0)	< 0.01	0.31
FIM motor (points)	57.9 (14.1)	76.8 (11.5)	< 0.01	1.51
FIM cognitive (points)	29.0 (5.4)	30.8 (4.9)	< 0.01	0.53
FIM total (points)	86.9 (17.1)	107.5 (15.1)	< 0.01	1.48
QOL score: Self	0.56 (0.20)	0.74 (0.18)	< 0.01	0.90
QOL score: Proxy	0.55 (0.18)	0.74 (0.14)	< 0.01	0.95
Wilcoxon signed rank test SD standard deviation, MMSE Mini Mental State Examination, FIM Functional Independence Measure, QOL quality of life, SRM standardized response mean

For the coefficient of the degree of agreement, the ICC of the QOL value was 0.68 for the initial evaluation and 0.72 for the reevaluation (substantial agreement) (Table 3), and the scatter plot of the QOL values for the participant’s response and proxy’s response is shown in Fig. 1. The κ coefficient of the degree of agreement of the sub-items ranged from 0.31 to 0.56 (fair to moderate agreement) (Table 3), and the levels selected by the participant and by the proxy are shown in Table 4.

Table 3

Agreement between self and proxy responses
	Initial evaluation				Re-evaluation
	Coefficient	95% CI	F value	p value	Coefficient	95% CI	F value	p value
QOL score	0.68	0.54; 0.79	5.28	< 0.01	0.72	0.59; 0.81	6.09	< 0.01
	Initial evaluation				Re-evaluation
	Coefficient	95% CI	Z value	p value	Coefficient	95% CI	Z value	p value
Mobility	0.55	0.41; 0.68	6.86	< 0.01	0.50	0.33; 0.67	6.90	< 0.01
Self-care	0.56	0.43; 0.68	7.98	< 0.01	0.56	0.40; 0.72	6.74	< 0.01
Usual activities	0.42	0.27; 0.56	5.80	< 0.01	0.31	0.17; 0.45	4.31	< 0.01
Pain/discomfort	0.51	0.38; 0.65	6.82	< 0.01	0.48	0.33; 0.63	6.87	< 0.01
Anxiety/depression	0.33	0.16; 0.50	4.00	< 0.01	0.41	0.22; 0.60	4.55	< 0.01
CI confidence interval, QOL quality of life

Table 4

Selected level of self and proxy
	Initial evaluation							Re-evaluation
	Proxy							Proxy
		Level	1	2	3	4	5		Level	1	2	3	4	5
Mobility	Self	1	1	5	4	0	1	Self	1	15	11	1	1	0
		2	1	17	2	1	1		2	4	30	3	0	0
		3	0	3	7	4	0		3	0	3	3	0	0
		4	0	3	3	3	0		4	0	1	0	1	0
		5	0	1	3	2	15		5	0	1	1	1	1
Self-care	Self	1	11	11	3	0	0	Self	1	34	10	1	0	0
		2	2	21	7	0	0		2	6	16	3	0	0
		3	0	2	8	1	0		3	0	1	2	0	0
		4	0	1	1	3	0		4	0	1	0	2	0
		5	0	0	2	3	1		5	0	0	1	0	0
Usual activities	Self	1	1	5	5	1	0	Self	1	12	14	2	2	0
		2	1	8	1	5	0		2	3	19	4	1	0
		3	0	6	12	3	0		3	0	7	4	0	0
		4	0	4	5	6	0		4	0	3	4	0	1
		5	0	0	2	4	8		5	0	0	1	0	0
Pain/discomfort	Self	1	5	3	0	0	0	Self	1	13	4	0	0	0
		2	4	25	6	2	0		2	6	32	4	0	0
		3	0	5	12	2	2		3	0	8	5	0	0
		4	0	1	4	4	1		4	0	0	1	0	0
		5	0	0	1	0	0		5	0	2	1	1	0
Anxiety/depression	Self	1	23	15	1	0	0	Self	1	41	8	0	0	0
		2	8	9	3	1	0		2	9	11	2	0	0
		3	5	4	3	2	0		3	1	1	2	0	0
		4	0	0	1	1	0		4	0	1	0	0	0
		5	0	0	0	1	0		5	1	0	0	0	0
Bold numbers indicate perfectly matched answers Units: number of people

Before and after rehabilitation, not only ADL but also HRQOL improved, which is considered to be due to the comprehensive approach to rehabilitation. Moreover, the effect size shown suggested this approach to be responsive as an outcome for patients with musculoskeletal disorders in a recovery-phase rehabilitation ward.

The SRM in the report by Li et al. [3] was moderate at 0.53, which may be due to the fact that the patients were not inpatients but community residents. The SRMs reported by Conner-Spady et al. [23] were 1.53 for hip joint disease and 1.04 for knee joint disease, which are large values. This was a comparison between before and after surgery, and the evaluation period was one year, so both factors could be considered. Lin et al. [24] reported SRMs before and after surgery for hip disease of 1.40 at 6 weeks and 1.70 at 6 months postoperatively. They also showed that the EQ-5D-5L values were 0.63 at 6 weeks and 0.78 at 6 months.

On the other hand, this study was conducted on patients admitted to a recovery phase ward and examined responsiveness from the post-operative period. Therefore, it is likely that the SRM was lower than the value before and after surgery and higher than the value in community-dwelling patients. And compared to the report by Lin et al. [24] the EQ-5D-5L values in the present study were 0.56 at the initial evaluation and 0.74 at the re-evaluation (approximately one month after the initial evaluation), indicating that the QOL values improved in a shorter period of time, indicating the effectiveness of rehabilitation.

In previous studies, it was reported that particularly when the family member was the proxy, the degree of agreement was lower than that of the participant [19, 20], but in the present study, the response by the proxy OT indicated a moderate to high degree of agreement.

Tol et al. [7] reported an ICC of 0.66 for outpatient orthopaedic conditions when the proxy was spouse. In the present study, the ICC exceeded 0.66 at both assessments, which was a higher agreement than when the proxy assessment was carried out by spouse. Pickard et al. [6] reported a baseline value of 0.57 and a one-month value of 0.75, while Izumi et al. [8] reported a value of 0.62 at the initial evaluation and 0.78 at the re-evaluation (approximately one month after the initial evaluation). In both reports, the value at re-evaluation exceeded 0.70, which COSMIN describes as a 'good measurement properties'.

In the present study, the values were 0.68 for the initial evaluation and 0.72 for the re-evaluation, showing a similar trend. This indicates that the proxy evaluation at the initial evaluation may differ from the individual's response, but the value at re-evaluation is a reliable value. The results of the present study suggest that proxy evaluations after one month can be recommended.

The sub-items showed a moderate degree of agreement, except for “anxiety/depression” in the initial evaluation and “normal activities” in the reevaluation. The degree of agreement for “anxiety/depression” was lower than that of the other sub-items. However, in a study by Pickard et al. [6] using the EQ-5D in stroke patients, the initial evaluation of the degree of agreement for “anxiety/depression” showed a value of 0.18, and therefore, the present study showed higher values. The reason is thought to be that in a study by Pickard et al. [6] the proxy was a family caregiver (such as a spouse or partner, sibling, or offspring or, if unavailable, a friend). In this study, the proxy was an occupational therapist and in the occupational therapy is a curriculum that emphasizes both physical function and mental function during training, thus making it possible for OTs receive training to pick-up on behavioral and expressive cues that intimate states of anxiety and depression. In addition, the reason for the improvement in the degree of agreement between QOL values in the reevaluation compared with the initial evaluation was assumed to be that the degree of agreement between the sub-items was large, the degree of deviation in the selected level of “anxiety/depression” between the participant and the proxy decreased (Table 4), and the variation was also reduced as shown in the scatter plot in Fig. 1.

The mean number of billing units of an OT per patient in a day in the recovery-phase rehabilitation ward is 2.97 [13], indicating that an OT is in contact with participant on a one-to-one basis for an average of 1 hour every day. The mean period from the initial evaluation to reevaluation was 31.9 days, and it can be inferred that the condition of participant could be understood during this period and that the degree of agreement has improved.

However, although the degree of agreement of QOL values was high, the degree of agreement was low for some sub-items, and therefore, it is necessary to consider this when examining the proxy’s response for the sub-items. As another point to consider, it is necessary for the proxy to observe the whole life of the participant in the ward instead of just during rehabilitation. On the participant side, it is necessary to understand the characteristics of the participant. That is, if the participant has depressive tendencies and low self-esteem, it is predicted that the participant will show low values for items other than mental and psychological ones, and it is therefore necessary to base the proxy’s response on these factors.

Limitations of study and future vision

In this study, all musculoskeletal disorders were analyzed, but as clinical symptoms are different in hip fracture, osteoarthritis, and vertebral fracture, it is necessary to verify them for each diagnosis and to define the QOL value by severity, with analyses of other diseases also necessary. Short-term analysis was performed in this study, but it will also be necessary to investigate the changes in long-term HRQOL. For the proxy’s response by this study method, the QOL value may be different based on the viewpoint of the proxy (family member, caretaker, healthcare professional, etc.), and therefore, it is necessary to interpret the results carefully [21, 22]. Because the proxy’s responses were made for participants who could respond by themselves, it will be necessary to further verify whether HRQOL can be measured by proxy for those participants who truly cannot respond by themselves.

The measurement characteristics of the EQ-5D-5L in orthopaedic diseases were found to be high responsiveness and inter-rater reliability with a substantial agreement. In particular, inter-rater reliability was shown to be a 'good measurement properties' at reassessment.

EQ-5D-5L EuroQol 5-Dimension 5-Level

EQ-5D-3L EuroQol 5-Dimension 3-Level

FIM Functional Independence Measure

HRQOL Health-Related Quality of Life

ICC Intraclass Correlation Coefficient

MMSE Mini Mental State Examination

OT Occupational Therapist

PRO Patient-Reported Outcomes

QALY Quality-Adjusted Life Year

SD Standard Deviation

SRM Standardized Response Mean

Ethics approval and consent to participate

In conducting this study, ethical consideration were made in accordance with the Ethical Guidelines for Medical Research in Humans and declaration of Helsinki. Moreover, written informed consent was obtained from the subjects of this study, and this study was approved by the ethical review board of Seirei Christopher University (approval no.: 16045, Internal Review Board; Seirei Christopher University). And as it is not a clinical trial, the clinical trial number is not applicable.

Consent for publication

Not applicable.

Availability of data and materials

The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.

Competing interests

The authors declare that they have no competing interests.

Funding

This work was supported by JSPS KAKENHI Grant Number 19K10493.

Authors’ contributions

RI, SN, and HN conceived and designed the study. RI, TS, HT, and DT conducted data collection, entry, and analysis. All authors read and approved the final manuscript.

Acknowledgements

We very much thank the subjects and occupational therapists in the hospitals for their cooperation in this study.

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No competing interests reported.

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Degree of coincidence of the change in health-related quality of life in the recovery-phase rehabilitation ward and the proxy’s response: Evaluation of patients with musculoskeletal disorder by EQ-5D-5L

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Abstract

Background

Methods

Results

Conclusions

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Background

Objectives

Methods

Study design and participants

EQ-5D-5L scale

Statistical method and ethical procedures

Results

Discussion

Limitations of study and future vision

Conclusions

Abbreviations

Declarations

References

Additional Declarations

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Version 1