Physical restraint of dementia patients in acute care hospitals during the COVID-19 pandemic: A cohort analysis in Japan.

INTRODUCTION: The coronavirus disease (COVID-19) pandemic has caused unprecedented challenges for the medical staff worldwide, especially for those in hospitals where COVID-19-positive patients are hospitalized. The announcement of COVID-19 hospital restrictions by the Japanese government has led to several limitations in hospital care, including an increased use of physical restraints, which could affect the care of elderly dementia patients. However, few studies have empirically validated the impact of physical restraint use during the COVID-19 pandemic. We aimed to evaluate the impact of regulatory changes, consequent to the pandemic, on physical restraint use among elderly dementia patients in acute care hospitals.
METHODS: In this retrospective study, we extracted the data of elderly patients (aged > 64 years) who received dementia care in acute care hospitals between January 6, 2019, and July 4, 2020. We divided patients into two groups depending on whether they were admitted to hospitals that received COVID-19-positive patients. We calculated descriptive statistics to compare the trend in 2-week intervals and conducted an interrupted time-series analysis to validate the changes in the use of physical restraint.
RESULTS: In hospitals that received COVID-19-positive patients, the number of patients who were physically restrained per 1,000 hospital admissions increased after the government's announcement, with a maximum incidence of 501.4 per 1,000 hospital admissions between the 73rd and 74th week after the announcement. Additionally, a significant increase in the use of physical restraints for elderly dementia patients was noted (p = 0.004) in hospitals that received COVID-19-positive patients. Elderly dementia patients who required personal care experienced a significant increase in the use of physical restraints during the COVID-19 pandemic.
CONCLUSION: Understanding the causes and mechanisms underlying an increased use of physical restraints for dementia patients can help design more effective care protocols for similar future situations.

Introduction

The rapid spread of coronavirus disease (COVID-19) has progressively increased and continues to disrupt healthcare systems worldwide [1]. In acute care hospitals, especially those treating COVID-19 patients, the medical staff members face difficulties in providing routine care owing to patient triage, social distancing, and shortage of resources such as finances, medical supplies, and manpower [2-4]. To manage the pandemic, the Japanese government announced hospital restrictions, including those pertaining to family visits, at the end of March 2020. Eventually, a state of emergency was declared for specific areas on 7th April, 2020, and implemented nationwide on 16th April, 2020. Social distancing and limiting family visits impacted the hospital care systems in many ways, such as reduced communications with medical staff and family members; these in turn could exacerbate progressive cognitive dysfunction and worsen behavioral and psychological symptoms in dementia patients and consequently, result in higher distress to both patients and medical staff [5].

The use of physical restraint for dementia patients has been discussed in recent years. Physical restraint is often used in acute care settings [6-8] and includes 11 means of mechanical restraint based on national guidelines for the prevention of physical restraints [9]. However, such means may confer critical medical disadvantages for patients, including restraint device-related injuries, such as asphyxiation or chest compression, and immobility-related complications, such as deep vein thrombosis, pulmonary embolism, aspiration pneumonia, and rhabdomyolysis [10-13].

Owing to the abovementioned disadvantages and ethical concerns, recommendations to avoid the use of physical restraint have been made worldwide, including Japan [14-16]. Since 2016, in Japan, the Ministry of Health, Labour and Welfare (MHLW) has factored in an additional fee in the universal benefit scheme for dementia care of patients without severe disorientation who need personal care, wherein a financial disincentive of 40% reduction is provided if physical restraint is used [17]. As dementia symptoms may not be recognizable during routine care, this benefit may be particularly applicable to patients who have communication-related challenges or symptoms that inhibit their daily life without diagnosis of dementia [18]. To be eligible to obtain the stipulated benefit, nurses need to be trained in dementia care, and a standardized protocol for mechanical and chemical restraint procedures for sedation is required [17].

Providing routine comprehensive care for dementia patients may have been especially challenging during the 1st wave of the COVID-19 pandemic as the unprecedented crisis seriously impacted the healthcare systems [5]. However, only few studies have explored the impact of the COVID-19 pandemic on dementia care, especially with regard to physical restraint use for dementia patients. Therefore, in this retrospective cohort study, we aimed to evaluate the changes in the use of physical restraints among dementia patients in acute care hospitals stratified on the basis of them receiving or not receiving COVID-19-positive patients. We hypothesized that dementia patients are more likely to be physical restrained during the pandemic in acute care hospitals that treat COVID-19 patients than during pandemic-free time periods.

Materials and methods

Data source

We used the Diagnosis Procedure Combination (DPC) data from the Quality Indicator/Improvement Project (QIP) database in Japan. The QIP participant hospitals provide claims data and DPC data to improve their system and quality of care using quality indicators. Across Japan, more than 200 QIP participant hospitals, both public and private, and of various sizes were included; in these hospitals, the number of general beds (hospital beds not earmarked as psychiatric, infectious disease, and tuberculosis beds) according to the Japanese classification of hospital beds ranged from 30 to 1,151 in 2019.

The DPC/per-diem payment system (PDPS) is a Japanese prospective payment system that is used in acute care hospitals and is comparable to diagnosis-related databases in the United States [19, 20]. A total of 1,730 hospitals adopted the DPC/PDPS in 2018, which accounted for 54% of all general beds in Japanese hospitals [21, 22]. However, the DPC data do not include detailed information on the level of nursing care; instead, they provide information such as primary diagnoses, comorbidities (identified using the International Classification of Diseases, 10th Revision [ICD-10] codes), drug or device prescriptions, and codes corresponding to the performed medical procedures as stated in the discharge summary.

Study population

The eligibility criteria for inclusion in this study were as follows: age > 64 years; availability of admission and discharge summary for 78 weeks between January 6, 2019, and July 4, 2020; and application of dementia care benefit during admission. We excluded patients who were admitted to the intensive care unit or were hospitalized for COVID-19 treatment because their clinical characteristics and disease severity greatly differed from those of other dementia patients, and therefore, the use of physical restraints in the former could be a consequence of other factors/mechanisms.

Variables

We obtained information on patients’ sex, age, ambulance use, admission type, admission pathway, comorbidity indices (Charlson Comorbidity Index [CCI]) [23], whether a surgical procedure was conducted, reason for admission based on the ICD-10 codes (infection, neoplasm, endocrine, mental and behavioral, nervous, circulatory, respiratory, digestive, musculoskeletal, genitourinary, injury, and others), and length of stay (LOS) to examine the baseline patient characteristics. The patients were assigned to three groups based on age (65–74, 75–84, and ≥ 85 years). LOS is presented as the median and interquartile range. The outcome of interest was the frequency of physical restraint use among patients who applied for dementia care benefit. Data regarding the use of physical restraint during dementia care were extracted from the payment codes for services.

Statistical analysis

First, we divided the 78-week period into 39 categories of 2-week intervals based on the admission data and specified the appropriate timing category of the announcement of COVID-19 hospital restrictions by the Japanese government (33rd out of 39 categories) as the point of implementation, the state of emergency. In Japan, hospitals that can accept COVID-19-positive patients were designated by the MHLW. If no COVID-19-positive patients were hospitalized during this study period, we considered that the impact of COVID-19 was small. Therefore, we categorized the study population into two groups: hospitals having at least one COVID-19-positive patient admission during the study period (Group 1) and those having none (Group 2). Subsequently, we divided our datasets into two periods for the interrupted time-series (ITS) analysis: pre- (1–32) and post-announcement (33–39). Comparisons were conducted using the chi-squared test or Fisher’s exact test or the Kruskal–Wallis rank sum test, as appropriate. Thereafter, to examine the trend, the number of patients who were physically restrained per 1,000 hospitalizations as indicated for every 2 weeks during the whole study period are presented in line graphs for each group. Finally, we used ITS, including segmented regressions, to ascertain the impact of the government’s announcement of the state of emergency. We statistically assessed the changes in the number of patients who were physically restrained per 1,000 hospitalizations and who were provided with the dementia care benefit based on the date of admission adjusted for seasonality through a Fourier term [24]. The level of statistical significance was set at p < 0.05 (two-tailed). Statistical analyses were performed with R version 4.0.2 (R Foundation for Statistical Computing, Vienna, Austria).

The study protocol was approved by the Ethics Committee, Kyoto University Graduate School and Faculty of Medicine. This study was conducted in accordance with the ethical guidelines issued by the Japanese National Government for medical and health research involving human participants. The data were anonymized, and the requirement for informed consent was waived by the approving authority.

Results

We identified 158,797 admissions from 245 hospitals. After excluding patients admitted to the ICU (n = 2,737) and those being treated for COVID-19 (n = 204), 155,856 admissions were finally recognized. Thereafter, we divided the hospitals into 2 groups, admissions in hospitals that received COVID-19 positive patients (Group 1, 97,233 admissions) and those that received none (Group 2, 58,623 admissions), which are shown in Fig 1. Tables 1 and 2 show the demographics of patients who were eligible for inclusion from before to after the state of emergency announced by the MHLW in both groups. All variables are expressed as absolute numbers (n) and relative frequencies (%). Among the patients, those aged > 85 years comprised more than half of the study population, and most patients needed urgent or emergent hospitalization (Group 1: 86.6% vs. 86.9%; Group 2: 78.9% vs. 77.2%). In Group 1, the percentages of subjection to surgical procedures pre- and post-COVID-19-related regulatory intervention (11.7% vs. 12.1%; p = 0.094) were marginally high, whereas the percentage of CCI > 2 was low (19.8% vs. 18.5%; p < 0.001) after the intervention. Fig 2 displays the number of patients who were physically restrained per 1,000 hospitalizations (shown on the line) in both groups. Group 2 shows a lower number throughout the study period than Group 1. After the 66th week of announcement by the MHLW, the number of cases that required physical restriction per 1,000 hospitalizations increased, with a maximum of 501.4 during the 73rd and 74th week in Group 1. According to the ITS analysis in Fig 3, the number of patients who were physically restrained per 1,000 hospitalizations significantly increased only in Group 1 after the state of emergency was announced by the MHLW (Group 1: p = 0.004; Group 2: p = 0.437).

Fig 1

Flowchart depicting patient progression in this study based on the eligibility and exclusion criteria.

Table 1

Characteristics of patients who received dementia care before and after COVID-19-related regulatory changes in hospitals that received COVID-19-positive patients.

Characteristics	Pre-intervention	Post-intervention	p
Number of patients	80,468	16,765
Male, n (%)	34,410 (42.8)	7,084 (42.3)	0.23
Age, years, mean (SD)	85.01 (7.35)	84.97 (7.31)	0.611
Age category, years, n (%)			0.282
65–74	7,486 (9.3)	1,538 (9.2)
75–84	27,775 (34.5)	5,894 (35.2)
≥85	45,207 (56.2)	9,333 (55.7)
Ambulance use, n (%)	40,509 (50.3)	8,423 (50.2)	0.823
Urgent or emergent admission, n (%)	69,646 (86.6)	14,566 (86.9)	0.252
Admission pathway, n (%)			0.545
Home	51,478 (64.0)	10,651 (63.5)
Hospital or nursing home	28,932 (36.0)	6,101 (36.4)
Other	58 (0.1)	13 (0.1)
Charlson Comorbidity Index >2, n (%)	15,951 (19.8)	3,104 (18.5)	<0.001
Surgery during admission, n (%)	9,377 (11.7)	2,031 (12.1)	0.094
Reason for admission, n (%)			<0.001
Infection, n (%)	2,194 (2.7)	457 (2.7)
Neoplasm, n (%)	5,336 (6.6)	1,214 (7.2)
Endocrine, n (%)	4,047 (5.0)	827 (4.9)
Mental and behavioral, n (%)	360 (0.4)	68 (0.4)
Nervous, n (%)	2,579 (3.2)	501 (3.0)
Circulatory, n (%)	15,087 (18.7)	2,895 (17.3)
Respiratory, n (%)	16,829 (20.9)	2,936 (17.5)
Digestive, n (%)	8,414 (10.5)	1,947 (11.6)
Musculoskeletal, n (%)	2,187 (2.7)	463 (2.8)
Genitourinary, n (%)	6,750 (8.4)	1,587 (9.5)
Injury, n (%)	11,061 (13.7)	2,490 (14.9)
Others, n (%)	5,624 (6.9)	1,380 (8.0)
Length of stay, median (IQR)	21 [12, 39]	20 [12, 36]	<0.001

SD: standard deviation, IQR: interquartile range

Table 2

Characteristics of patients who received dementia care before and after COVID-19-related regulatory changes in hospitals that received no COVID-19-positive patients.

Characteristics	Pre-intervention	Post-intervention	P
Number of patients	48,424	10,199
Male, n (%)	19,746 (40.8)	4,223 (41.4)	0.245
Age, years, mean (SD)	85.51 (7.37)	85.34 (7.35)	0.029
Age category, years, n (%)			0.018
65–74	4,200 (8.7)	919 (9.0)
75–84	15,305 (31.6)	3,344 (32.8)
≥85	28,919 (59.7)	5,936 (58.2)
Ambulance use, n (%)	17,349 (35.8)	3,587 (35.2)	0.214
Urgent or emergent admission, n (%)	38,216 (78.9)	7,877 (77.2)	<0.001
Admission pathway, n (%)			0.826
Home	27,615 (57.0)	5,850 (57.4)
Hospital or nursing home	20,789 (42.9)	4,345 (42.6)
Other	20 (0.0)	4 (0.0)
Charlson Comorbidity Index >2, n (%)	9,029 (18.6)	1,907 (18.7)	0.913
Surgery during admission, n (%)	3,715 (7.7)	731 (7.2)	0.084
Reason for admission, n (%)			<0.001
Infection, n (%)	954 (2.0)	177 (1.7)
Neoplasm, n (%)	2,257 (4.7)	520 (5.1)
Endocrine, n (%)	2,370 (4.9)	563 (5.5)
Mental and behavioral, n (%)	421 (0.9)	102 (1.0)
Nervous, n (%)	1,936 (4.0)	362 (3.5)
Circulatory, n (%)	9,504 (19.6)	2,176 (21.3)
Respiratory, n (%)	10,760 (22.2)	1,761 (17.3)
Digestive, n (%)	4,056 (8.4)	900 (8.8)
Musculoskeletal, n (%)	1,827 (3.8)	446 (4.4)
Genitourinary, n (%)	4,122 (8.5)	910 (8.9)
Injury, n (%)	7,153 (14.8)	1,604 (15.7)
Others, n (%)	3,064 (6.3)	648 (6.4)
Length of stay, median (IQR)	25 [14, 50]	26 [14, 50]	0.579

Fig 2

Comparison of the number of patients restrained between the two groups.

The number of patients physically restrained per 1,000 hospital admissions for 2-week intervals between January 1, 2019, and June 30, 2020, in the two groups.

Fig 3

Interrupted time-series analysis of the number of patients who were restrained.

The number of patients physically restrained per 1,000 hospital admissions over time was evaluated with an interrupted time-series analysis including segmented regressions (Group 1: p = 0.032; Group 2: p = 0.341). The solid line represents the actual transition and the dotted line represents the hypothetical transition in the absence of intervention.

Discussion

This study examined the trends of dementia patients requiring nursing care who were physically restrained per 1,000 hospitalizations and tracked important changes in this regard during the COVID-19 pandemic in Japan. The main finding of our study was that following the MHLW’s announcement of COVID-19 hospital restrictions and the state of emergency, dementia patients who required nursing care were significantly more likely to be physically restrained in hospitals that received COVID-19-positive patients.

Dementia has increasingly gained importance as a public health concern, and the medical staff in acute care hospitals often need to provide dementia care to elderly patients [25, 26]. Physical restraint, which is preferably avoided wherever possible, in conformance with worldwide recommendations, is often exercised in acute care settings, especially for elderly patients and those with dementia [7, 8, 15, 27–29]. Physical restraint is exercised to prevent falls and self-extubation owing to the low availability of medical staff and inadequate resources to constantly monitor at-risk patients because of the immense workload [6, 30]. There are few reports about changes in the implementation rate of physical restraint due to disasters such as the COVID-19 pandemic. However, one recent observational study showed the possibility of increased use of physical restraint during the COVID-19 pandemic [31], which supports our results.

We believe that the main reason for the significantly increased use of physical restraints for elderly dementia patients in only Group 1 during the COVID-19 pandemic was due to factors associated with the quality of care. Although it has been reported that cognitive function of the elderly may worsen with social distancing being implemented nationwide in Japan [32, 33], the reason for an obvious increase in the use of physical restraint in the ITS analysis at the hospitals without any hospitalization of COVID-19-positive patients in this study was unclear.

The mental and physical statuses of the medical staff are important to provide the best care for patients. During the COVID-19 outbreak, the medical staff were under pressure owing to the heavy workload and higher risk of infection due to lack of sufficient personal protective equipment [34-36]. Owing to the increase in nosocomial infections from February to April, 2020, medical staff were seen as epicenters, and this led to widespread irrational prejudice and discrimination against them in off duty-hours. They were denied use of public vehicles and their children were asked to refrain from attending nursery schools [36]. In hospital, nurses are required to take care of several patients simultaneously during pandemics, such as the COVID-19 pandemic [37], while wearing personal protective equipment, which makes communication difficult. The threshold for physically restraining elderly dementia patients may have been lowered owing to changes in the care system that have occurred consequent to the implementation of hospital strategies or owing to an increase in both physical and mental strain on medical staff.

Factors associated with the care system, including limiting family visits, might have also possibly affected the result. In Japan, even the state of emergency is not legally binding; therefore, the hospital visit restrictions at hospitals without COVID-19 positive patients might have been more permissive than hospitals with COVID-19-positive patients’ hospitalizations. For dementia patients, communicating with visitors, especially family members, is important to maintain their cognitive function [29, 31, 38, 39]. The Centers for Disease Control and Prevention guidelines allow care partners to visit patients if they are essential to the patients’ physical or emotional well-being, even during the COVID-19 pandemic [40]. Furthermore, use of telemedicine and digital technology can be helpful for the management of chronic neurological diseases, including dementia and cognitive impairment [41].

This study had several limitations. First, the severity of manpower shortage and the extent to which the restriction regarding family visitation was strictly enforced were unclear. More thorough infection control measures were considered to be practiced in hospitals that treated COVID-19-positive patients than in hospitals that did not. However, we could not consider and evaluate different burdens on the medical staff owing to differences in the number of admissions of COVID-19-positive patients in the target hospitals. To manage restrictions on in-person visits owing to the COVID-19 pandemic, some hospitals have been attempting to ensure a virtual connection between patients and their loved ones via tablets or smartphones. Despite the limitations in the use of technology, including difficulty in hearing over devices, patients can benefit by communicating with their family members [42]. Second, we could not evaluate the exact quality of dementia care in each group. As shown in Fig 2, hospitals with COVID-19-positive cases already have higher percentages of restraint in the hospital than those before the COVID-19 pandemic. It may be desirable to evaluate the quality of dementia care and the involvement of a geriatric specialist; however, this is not possible owing to a limited database. However, the target population for this study was the inpatients for whom dementia care benefit was calculated. We believe that the quality of care in the two populations is secured to a certain extent because the hospitals need to have staff trained in dementia care and conduct regular care meetings in order to calculate the additional fee. Additionally, since this study uses the impact of COVID-19 as an intervention point to compare the percentage of physical restraint practices in the hospital for each group over time, we believe that this is not a problem. Third, we could not detect the type or severity of dementia, which is often not recognized in general hospitals [18], as the applicable benefit did not require precise information about dementia. However, patients who were eligible for inclusion in this study were patients who were judged by the medical staff, trained in dementia care, as having dementia or an equivalent cognitive impairment that interfered with their daily lives and necessitated nursing care [17]. Moreover, the dementia care benefit cannot be applied to those who have severe disorientation (indicated with a Glasgow Coma Scale score < 9) [9, 17]. Therefore, we believe that patients with dementia of severity within a certain range were selected. Fourth, the proportions of each reason for hospitalization may differ before and after the COVID-19 pandemic. In this study, we attempted to evaluate the use of physical restraint to whole inpatient populations with cognitive impairment. Therefore, we could not fully consider the difference in the implementation rate of physical restraint use per disease.

However, we included large sample sizes, which is a strength of our study. Multicomponent interventions that increase medical staff awareness have limited effectiveness in reducing physical restraint use [16]; however, we believe that examining the current situation during the pandemic can significantly help prepare for similar future circumstances.

Conclusions

We demonstrated and validated a trend of increased use of physical restraints for elderly dementia patients using ITS analyses of administrative data. Elderly dementia patients who require personal care might be more likely to be physically restrained during the COVID-19 pandemic in hospitals receiving COVID-19-positive patients. While limited social interaction is inevitable to prevent the spread of COVID-19, the promotion of telemedicine and mental or physical care for medical staff may be important in reducing the use of physical restraints among dementia care patients. Future research should identify causative factors, including patient environment and stress among medical staff members, that lead to the increased use of physical restraints and explore avenues to reduce this use in future pandemics.

9 Aug 2021

PONE-D-21-19437

Physical restraint of dementia patients in acute care hospitals during the COVID-19 pandemic: A cohort analysis in Japan

PLOS ONE

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Reviewer #1: In the background of the study, please describe how dose COVID-19 affect the care of patient with dementia in the hospital? is there visitation restriction? Isolation policy? Relocation of patient with dementia due to COVID case segregation? Manpower shortage? Dose hospital without COVID affected by those regulations?

Please explain what is "136 Hp with 97,233 admissions"

Please explain and elaborate why BMI is choosen as one of the parameter to group patients?

In figure 2, before COVID, hospital takes COVID cases already have higher percentage of restraint in the hospital. Is it because the hospital is less well trained in dementia care? No geriatric specialist? If a hospital already prone to restraint dementia patient (lack of geriatric culture), COVID -19 will only aggregate it. Will be good to explain as this may make the comparison between the hospitals become unfair.

Reviewer #2: General comments

The authors conducted a retrospective cohort study to assess the impact of regulatory changes, consequent to the pandemic, on physical restraint use among elderly dementia patients in acute care hospitals in Japan. Main finding suggests elderly dementia patients who require personal care might be more likely to be physically restrained during the COVID-19 pandemic in hospitals receiving COVID-19-positive patients. The result was notable and very interesting. However, I have some concerns that should be addressed regarding the methodology and interpretation of results.

Specific comments

Major

It would be better to provide more detailed definitions of the state of emergency declaration and Group 1/2. Is the state of emergency nationwide or only for a specific region? Why was the deadline set at July 4, 2020? Did the group 1 receive COVID-19 patients only after the state of emergency was declared or not regardless of the time of declaration?

L.195-205 This second paragraph is a general statement and does not seem to be relevant to the results of this study. Therefore, by changing this paragraph to a comparison of this study with past studies on physical restraint, the authors can make this study more unique. For example, comparing the study of physical restraint with other social changes such as endemics or epidemics of other infectious diseases, disasters, or terrorism.

L.209-222 This paragraph is the reason why physical restraint increased after the COVID-19 pandemic. It does not explain why group 1 has more physical restraints than group 2. This is because if the state of emergency had been declared at the national level, group 2 would have been recommended the same social distance as group 1. If it is due to social distance, the authors should divide the hospitals according to whether they are in an epidemic area or not, not whether they accept COVID-19 patients or not. Smaller hospitals may not be accepting COVID-19 patients even in epidemic areas. It would be better to reconsider the difference in patient factors between Group 1 and Group 2.

L. 223-241 The restriction of visits seems to be done regardless of the acceptance of COVID-19 patients. As stated in L237-240, the changes in the nursing side seems to be a strong factor. It may be better to move L237-240 to the first half of this paragraph and elaborate further.

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It may be easier for readers to read the abstract if it is divided into Introduction, methods, results, and conclusion.

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2 Oct 2021

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PONE-D-21-19437

Physical restraint of dementia patients in acute care hospitals during the COVID-19 pandemic: A cohort analysis in Japan

PLOS ONE

Dear Dr. Imanaka,

Please submit your revised manuscript by Sep 23 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

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Response: Thank you for this reminder. I have checked the manuscript and made sure that it complies with the style requirement of your journal.

2. Please report the codes used for extracting the outcome of interest (use of physical restraints) from the database

Response:

The "code" is the Japanese medical fee code and is standardized for all medical institutions. Patients who are judged to have cognitive dysfunction and need special care are given an additional fee for dementia care; however, if physical restraint is used, the additional fee for dementia care is multiplied by 0.6.

Lines 121-122

The following has been added: “Data regarding the use of physical restraint during dementia care were extracted from the payment codes for services.”

＊Changes of reference list

Reference 9: remove the previous reference and replace it with relevant current reference

Reference 31: A relatively new report about physical restraining during the COVID-19 pandemic was added, which could be supportive of the result of this study.

Reviewer #1:

Q.　In the background of the study, please describe how dose COVID-19 affect the care of patient with dementia in the hospital? is there visitation restriction? Isolation policy? Relocation of patient with dementia due to COVID case segregation? Manpower shortage? Dose hospital without COVID affected by those regulations?

Response: Lines 48-52

Thank you for your comment.

The following has been added: “Social distancing and limiting family visits impacted the hospital care systems in many ways, such as reduced communications with medical staff and family members; these in turn could exacerbate progressive cognitive dysfunction …”

A more detailed description has also been added in the Discussion section regarding this point.

Q. Please explain what is "136 Hp with 97,233 admissions"

Response：Thank you for this comment. I had quoted the number of hospitals and admissions included in our study, which was also shown in Figure 1. However, in the manuscript, I think mentioning the number of hospitals is not absolutely essential and may create confusion as pointed out. Therefore, I have deleted the number of hospitals (Hp).

Q. Please explain and elaborate why BMI is chosen as one of the parameter to group patients?

Response：Thank you for this comment. In order to be able to more easily understand the distribution and missing information from the Table, we categorized the BMI. However, BMI information, including missing or not, is unimportant in the context of this study; hence, it was removed from Table 1.

Q. In figure 2, before COVID, hospital takes COVID cases already have higher percentage of restraint in the hospital. Is it because the hospital is less well trained in dementia care? No geriatric specialist? If a hospital already prone to restraint dementia patient (lack of geriatric culture), COVID -19 will only aggregate it. Will be good to explain as this may make the comparison between the hospitals become unfair.

Response：Lines 255-265

The following has been added: “As shown in Figure 2, hospitals with COVID-19-positive cases already have higher percentages of restraint in the hospital than those before the COVID-19 pandemic. It may be desirable to evaluate the quality of dementia care and the involvement of a geriatric specialist; however, this is not possible owing to a limited database. However, the target population for this study was the inpatients for whom dementia care benefit was calculated. We believe that the quality of care in the two populations is secured to a certain extent because the hospitals need to have staff trained in dementia care and conduct regular care meetings in order to calculate the additional fee. Additionally, since this study uses the impact of COVID-19 as an intervention point to compare the percentage of physical restraint practices in the hospital for each group over time, we believe that this is not a problem.”

(Supplement): Owing to lack of data, I am unable to present the quality of care; nevertheless, I have information regarding the presence of the dementia care team.

Group 1 January 2019 to February 2020 March 2020 to June 2020

Number of patients 80,468 16,765

Cared by dementia care team, n (%) 36193 (45.0) 9127 (54.4)

Group 2 January 2019 to February 2020 March 2020 to June 2020

Number of patients 48,424 10,199

Cared by dementia care team, n (%) 13719 (28.3) 3369 (33.0)

Reviewer #2: General comments

Specific comments

Major

Q. It would be better to provide more detailed definitions of the state of emergency declaration and Group 1/2. Is the state of emergency nationwide or only for a specific region? Why was the deadline set at July 4, 2020? Did the group 1 receive COVID-19 patients only after the state of emergency was declared or not regardless of the time of declaration?

Response：Thank you for this comment. Since this study targeted the first wave, which caused unprecedented disruptions, the study period was up to July, when the reemergence of the infection occurred (July 4 was chosen because we thought it would be preferable to aggregate the data on a weekly basis).

Lines 47-50

The following has been added: “To manage the pandemic, the Japanese government announced hospital restrictions, including those pertaining to family visits, at the end of March 2020. Eventually, a state of emergency was declared for specific areas on 7th Aprill 2020, and implemented nationwide on 16th April, 2020.”

Lines 128-133

The following has been added: “In Japan, hospitals that can accept COVID-19-positive patients were designated by the MHLW. If no COVID-19-positive patients were hospitalized during this study period, we considered that the impact of COVID-19 was small. Therefore, we categorized the study population into two groups: hospitals having at least one COVID-19-positive patient admission during the study period (Group 1) and those having none (Group 2).”

Q. L.195-205 This second paragraph is a general statement and does not seem to be relevant to the results of this study. Therefore, by changing this paragraph to a comparison of this study with past studies on physical restraint, the authors can make this study more unique. For example, comparing the study of physical restraint with other social changes such as endemics or epidemics of other infectious diseases, disasters, or terrorism.

Response: Lines 204-214

The following has been added: “Dementia has increasingly gained importance as a public health concern, and the medical staff in acute care hospitals often needs to provide dementia care to elderly patients [25, 26]. Physical restraint, which is preferably avoided wherever possible, in conformance with worldwide recommendations, is often exercised in acute care settings, especially for elderly patients and those with dementia [7,8,15,27-29]. Physical restraint is exercised to prevent falls and self-extubation owing to the low availability of medical staff and inadequate resources to constantly monitor at-risk patients because of the immense workload [6,30]. There are few reports about changes in the implementation rate of physical restraint due to disasters such as the COVID-19 pandemic. However, one recent observational study showed the possibility of increased use of physical restraint during the COVID-19 pandemic [31], which supports our results.”

Q. L.209-222 This paragraph is the reason why physical restraint increased after the COVID-19 pandemic. It does not explain why group 1 has more physical restraints than group 2. This is because if the state of emergency had been declared at the national level, group 2 would have been recommended the same social distance as group 1. If it is due to social distance, the authors should divide the hospitals according to whether they are in an epidemic area or not, not whether they accept COVID-19 patients or not. Smaller hospitals may not be accepting COVID-19 patients even in epidemic areas. It would be better to reconsider the difference in patient factors between Group 1 and Group 2.

Q. L. 223-241 The restriction of visits seems to be done regardless of the acceptance of COVID-19 patients. As stated in L237-240, the changes in the nursing side seems to be a strong factor. It may be better to move L237-240 to the first half of this paragraph and elaborate further.

Response: The above two questions are related points from the same paragraph and, hence, I would like to respond to them together.

We believe that there could be two reasons for the increase in the use of physical restraint: 1) patient factors due to the spread of COVID-19, and 2) hospital (medical staff) factors. However, as pointed out by the reviewer, reason 1) is not in accordance with the results of this study. Therefore, as pointed out by the reviewer, we focused our discussion on the hospital (medical staff) factors only. As one of the reasons for considering the hospital (medical staff) factor to be strong, I would like to add that although it has been reported that cognitive function of the elderly may worsen with social distancing being implemented nationwide in Japan, we could not point out a reason for the obvious increase in the use of physical restraint in the ITS analysis at the hospitals without any hospitalization of COVID-19-positive patients in this study.

Lines 215-221

The following has been added: “We believe that the main reason for the significantly increased use of physical restraints for elderly dementia patients in only Group 1 during the COVID-19 pandemic was due to factors associated with the quality of care. Although it has been reported that cognitive function of the elderly may worsen with social distancing being implemented nationwide in Japan [32,33], the reason for an obvious increase in the use of physical restraint in the ITS analysis at the hospitals without any hospitalization of COVID-19-positive patients in this study was unclear.”

Lines 225-228

The following has been added: “Owing to the increase in nosocomial infections from February to April, 2020, medical staff were seen as epicenters, and this led to widespread irrational prejudice and discrimination against them in off duty-hours. They were denied use of public vehicles and their children were asked to refrain from attending nursery schools [36].”

Lines 235-242

The following has been added: “Factors associated with the care system, including limiting family visits, might have also possibly affected the result. In Japan, even the state of emergency is not legally binding; therefore, the hospital visit restrictions at hospitals without COVID-19 positive patients might have been more permissive than hospitals with COVID-19-positive patients’ hospitalizations. For dementia patients, communicating with visitors, especially family members, is important to maintain their cognitive function [29,31,38,39]. The Centers for Disease Control and Prevention guidelines allow care partners to visit patients if they are essential to the patients’ physical or emotional well-being, even during the COVID-19 pandemic [40].”

Minor

It may be easier for readers to read the abstract if it is divided into Introduction, methods, results, and conclusion.

Response

As per your suggestion, the abstract has been divided into sub-headings.

Submitted filename: Responce_to_Reviewers.docx

Click here for additional data file.

10 Nov 2021

Physical restraint of dementia patients in acute care hospitals during the COVID-19 pandemic: A cohort analysis in Japan

PONE-D-21-19437R1

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12 Nov 2021

PONE-D-21-19437R1

Physical restraint of dementia patients in acute care hospitals during the COVID-19 pandemic: A cohort analysis in Japan

Dear Dr. Imanaka:

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