Cancellation Criteria of Acute Rehabilitation: Rehabilitation Risk Management
2019 Volume 4 Article ID: 20190013
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2019 Volume 4 Article ID: 20190013
Objective: This study aimed to investigate risk management during acute rehabilitation in cases where rehabilitation was canceled after prescription. Methods: Rehabilitation cases that were judged to be canceled after prescription in our hospital between April 1, 2017, and September 30, 2017, were investigated prospectively. The following parameters were examined: the total number of canceled rehabilitation therapies, the age and sex of the patients, the rehabilitation categories, the reasons for cancellation of rehabilitation, the clinical course after cancellation of rehabilitation, the number of cancellation cases with reasons corresponding to the cancellation criteria from the officially issued guidelines of the Japanese Association of Rehabilitation Medicine, and the applicable elements of the cancellation criteria. Results: Of the 2263 patients prescribed rehabilitation during the investigation period, rehabilitation was canceled in 110 (4.9%). The reasons for discontinuation were changes in vital signs in 53.6% of these 110 patients. Among the 21 patients in whom rehabilitation was stopped because of decreased oxygen saturation, six were found to have symptomatic pulmonary thromboembolism. In 92.8% of canceled cases, the reasons for cancellation corresponded to the cancellation criteria of rehabilitation. No serious adverse events were noted during the study period. Conclusion: The judgments of discontinuation of rehabilitation in this study were similar to the cancellation criteria of rehabilitation. Acute rehabilitation should be performed under the control of the cancellation criteria of rehabilitation.
In acute phase rehabilitation, rehabilitation begins soon after hospitalization or immediately after surgery. The 2015 stroke treatment guidelines from the Japan Stroke Association strongly recommend that patients undergo rehabilitation to prevent complications caused by immobility, to improve early activities of daily living (ADL), and to facilitate reintegration into society as soon as possible at an early stage after stroke onset (Grade A).1) Furthermore, Schweickert et al. reported that the Barthel index score of patients who started early rehabilitation within 72 h after intubation in the intensive care unit (ICU) had significantly increased at the time of discharge; they concluded that hyperacute rehabilitation in the ICU was effective in improving ADL.2) In all disease categories, early rehabilitation should be started to prevent secondary complications, such as disuse atrophy and pneumonia; positive outcomes of early active rehabilitation have been reported.3,4)
Rehabilitation in acute hospitals is conducted to halt functional deterioration caused by a disease or disease treatment and to restore function as early as possible. In acute phase rehabilitation, even in severe diseases, intervention begins in parallel with the course of treatment. Moreover, high-risk patients with multiple complications are included as targets for rehabilitation. Consequently, risk management during rehabilitation is considered particularly important.
The cancellation criteria of rehabilitation have been prescribed in the “Guidelines for Safety Management and Promotion” published by the Clinical Practice Guidelines Committee of the Japanese Association of Rehabilitation Medicine.5) According to the clinical guidelines committee, the cancellation criteria apply to four types of cases: “cases in which aggressive rehabilitation should be avoided,” “cases in which rehabilitation should be stopped and may be restarted after recovery,” “cases in which rehabilitation should be canceled,” and “cases in which other precautions are required” (Table 1). The criteria were originally written in Japanese and translated to English, after which back translation was done, and the meaning confirmed by a bilingual (English and Japanese) speaker. Of the elements of the cancellation criteria, 70% consist of chest symptoms and changes in vital signs.
| Cases in which aggressive rehabilitation should be
avoided
• Pulse rate at rest ≤40 beats/min or ≥120 beats/min • Systolic blood pressure at rest ≤70 mmHg or ≥200 mmHg • Diastolic blood pressure at rest ≥120 mmHg • Effort angina • Significant bradycardia or tachycardia in patients with atrial fibrillation • Poor cardiovascular hemodynamics in patients immediately after myocardial infarction • Significant arrhythmia • Chest pain at rest • Presence of palpitations, shortness of breath, or chest pain prior to rehabilitation • Dizziness, cold sweats, nausea, etc., in a sitting position • Body temperature at rest >38°C • Oxygen saturation at rest ≤90% |
Cases in which rehabilitation should be
canceled
• Higher than moderate degree of shortness of breath, dizziness, nausea, angina pectoris, headache, a strong feeling of fatigue, etc. • Heart rate >140 beats/min • Systolic blood pressure on exercise rises by more than 40 mmHg or diastolic blood pressure rises by more than 20 mmHg • Tachypnea (>30 cycles/min) or shortness of breath • Increased arrhythmia with exercise • Presence of bradycardia • Worsening level of consciousness |
| Cases in which rehabilitation should be stopped
and maybe restarted after recovery
• Heart rate exceeds 30% before exercise: cancel or change to very light exercise if it does not return to less than 10% before exercise after 2 minutes of rest • Heart rate >120 beats/min • 10 or more premature ventricular contractions in 1 minute • Presence of mild palpitation or shortness of breath |
Cases in which other precautions are
required
• Presence of hematuria • Increase in amounts of sputum • Increase in body weight • Presence of fatigue • Loss of appetite or fasting • Worsening edema of the lower extremity |
In general, when starting and continuing daily rehabilitation therapy, the doctor evaluates the patient’s condition, keeping in mind the cancellation criteria, and starts daily rehabilitation while monitoring the patient’s vital signs. If changes in the patient’s condition are evident, or if the patient so requests, part of the rehabilitation therapy will be canceled or ceased at the time of consultation or during rehabilitation therapy. Detailed additional examinations and treatment are implemented depending on the state of the patient at the time of therapy. Restarting rehabilitation is then considered based on the patient’s status the following day. Consequently, as a desirable protocol for risk management, when sudden unexpected changes occur in patient status during rehabilitation therapy, specific parts of the prescribed rehabilitation therapy are either canceled or postponed to avoid possible serious adverse events or worsening of the disease condition. Moreover, quick and appropriate treatment should be started without delay (Fig. 1).
Flow chart of the judgment for cancellation or restarting rehabilitation
There are several cancellation criteria of rehabilitation.5,6) Moreover, risk management is very important considering the tendency of rapid progression toward hyperacute rehabilitation in recent years. However, to the best of our knowledge, there are no reports describing cancellation of rehabilitation in acute rehabilitation or clarification of whether such cases comply with the established cancellation criteria.
In the current study, to examine safety management in acute phase rehabilitation, we aimed to investigate the total number of cases in which rehabilitation might be expected to be canceled, patients’ age and sex, categories of rehabilitation, subsequent clinical course, reason for cancellation, and the percentage of reasons that corresponded to the cancellation criteria of rehabilitation.
Subjects and MethodsIn our hospital, which is an acute phase-specific hospital, cases of planned physical rehabilitation therapies after prescription for any disease category from April 1, 2017, to September 30, 2017, were evaluated. We investigated cases in which daily rehabilitation therapy was not started or was judged to be canceled during physical therapy by doctors or rehabilitation staff. We recorded the reasons why rehabilitation was canceled. If there were multiple reasons for discontinuation, as many reasons as possible were recorded. We also selected the most critical element that caused the cancellation among multiple elements in each case. We investigated the total number of rehabilitation therapies that were canceled during the study period, patient age and sex, the category of rehabilitation, any surgical operation, the reason for cancellation, the subsequent rehabilitation course, the number of canceled cases where the reason complied with the cancellation criteria, and applicable elements in the cancellation criteria. Cases in which reasons for cancellation were consistent with one or more items in the cancellation criteria of rehabilitation were judged to comply with the cancellation criteria.
Data Analyses and Statistical TestsThe median age of the patients in whom rehabilitation was canceled was assessed for each disease category (Table 2). The Kruskal-Wallis test was used to compare the ages of non-cancellation patients, cancellation patients, and all patients with respect to the various disease categories. The Mann-Whitney test was used to compare the ages of the non-cancellation and cancellation cases in each category. The chi-squared test was used to compare the cancellation rates among the categories. We compared the main elements of cancellation in each category using the chi-squared test.
| Non-cancellation cases | Cancellation cases | Total | P-value (non-cancellation vs cancellation) |
||||||
| Case | Locomotor | 945 | 27 | 2.8% | 972 | ||||
| (n) | Stroke | 376 | 21 | 5.3% | 397 | ||||
| NMD | 104 | 8 | 7.1% | 112 | |||||
| Immobility | 233 | 8 | 3.3% | 241 | |||||
| Cardiovascular | 139 | 14 | 9.2% | 153 | |||||
| Pulmonary | 108 | 5 | 4.4% | 113 | |||||
| Cancer | 248 | 27 | 9.8% | 275 | |||||
| Total | 2153 | 110 | 4.9% | 2263 | |||||
| P-value (among the category) | Pa<0.001 | ||||||||
| M | F | M | F | M | F | ||||
| Sex | Locomotor | 350 | 595 | 21 | 6 | 371 | 601 | ||
| M/F | Stroke | 194 | 182 | 15 | 6 | 209 | 188 | ||
| (n) | NMD | 43 | 61 | 5 | 3 | 48 | 64 | ||
| Immobility | 129 | 104 | 2 | 6 | 131 | 110 | |||
| Cardiovascular | 84 | 55 | 7 | 7 | 91 | 62 | |||
| Pulmonary | 83 | 25 | 2 | 3 | 85 | 28 | |||
| Cancer | 159 | 89 | 21 | 6 | 180 | 95 | |||
| Total | 1042 | 1111 | 73 | 37 | 1115 | 1148 | |||
| Age | Locomotor | 68 | (12–92) | 71 | (19–69) | 68 | (12–92) | P-valuec 0.0783 | |
| median | Stroke | 73 | (37–93) | 73 | (54–90) | 73 | (37–93) | 0.520 | |
| (range) | NMDa | 75 | (27–96) | 77.5 | (53–89) | 75 | (27–96) | 0.206 | |
| (y) | Immobility | 80 | (26–96) | 83 | (49–94) | 80 | (26–96) | 0.677 | |
| Cardiovascular | 73 | (32–91) | 74 | (28–94) | 73 | (28–94) | 0.785 | ||
| Pulmonary | 76 | (50–95) | 83 | (54–87) | 77 | (50–95) | 0.075 | ||
| Cancer | 69 | (36–87) | 77 | (15–88) | 73 | (12–88) | 0.064 | ||
| Total | 69 | (12–96) | 76 | (19–94) | 71 | (12–96) | 0.492 | ||
| P-value (among the category) | Pb=0.4923 | Pb=0.5896 | Pb<0.001 | ||||||
| Operation | Locomotor | 696 | 24 | 720 | |||||
| (n) | Stroke | 141 | 7 | 148 | |||||
| NMDa | 5 | 0 | 5 | ||||||
| Immobility | 47 | 1 | 48 | ||||||
| Cardiovascular | 109 | 7 | 116 | ||||||
| Pulmonary | 5 | 0 | 5 | ||||||
| Cancer | 74 | 11 | 85 | ||||||
| Total | 1077 | 50 | 1127 | ||||||
NMD, neuromuscular disease.
aChi-squared test to compare the cancellation rate among the seven categories.
bKruskal-Wallis test to compare the ages among categories.
cMann-Whitney test to compare the ages of the non-cancellation and cancellation cases in each category.
All statistical analyses were performed using EZR (Saitama Medical Center, Jichi Medical University, Saitama, Japan), a graphical user interface for R (The R Foundation for Statistical Computing, Vienna, Austria). It is a modified version of the R Commander designed to add statistical functions frequently used in biostatistics.7) The level of statistical significance was set at P<0.05.
This study was conducted in accordance with the approval of the Research Ethics Committee of the Tokyo Medical and Dental University (M2018-073) and with the World Medical Association Declaration of Helsinki. Written informed consent was obtained from all patients.
Within the study period, physical rehabilitation therapies were performed in 2263 patients (Table 2). The median ages of patients were significantly different among the disease categories. However, the ages of cancellation patients and non-cancellation patients did not show significant differences among disease categories. Furthermore, the ages were not significantly different between non-cancellation patients and cancellation patients for any disease categories. However, the cancellation rate was significantly different among disease categories.
Among the 2263 rehabilitation patients, rehabilitation could not be started or was canceled in 110 (4.9%). These 110 patients were immediately re-examined in detail, and medication therapy was adjusted as necessary. Consequently, rehabilitation therapies were restarted in 105 patients the follwing day or 2 days later. However, rehabilitation in 16 of these patients was judged to be canceled again during the follow-up period. In five rehabilitation patients with end-stage cancer, rehabilitation could not be resumed. Moreover, 59 (53.6%) discontinuations were caused by vital sign elements (Table 3). Of the 110 discontinued cases, 102 (92.8%) were discontinued because of events that corresponded to the cancellation criteria of rehabilitation. Among these 102 patients, rehabilitation in two was judged to be canceled in accordance with the cancellation criteria, despite their blood pressure not having reached the prescribed value. This was because the cancellation criteria required stricter blood pressure control based on the characteristics of the disease treatment. In addition, rehabilitation was discontinued in eight cases (7.0%) for other reasons.
| Elements (multiple applicable) | Cases | Cancellation criteria | Vital signs | |
| Applied | Followed | |||
| Hypotension (BP<70 mmHg) | 40 | * | * | |
| Hypertension (BP>200 mmHg) | 19 | * | * | * |
| Decrease of oxygen saturation (SPO2 ˂90%) | 21 | * | * | |
| Tachycardia >120/min at rest >140/min on exercise | 26 | * | * | * |
| Bradycardia (HR <40/min) | 1 | * | * | |
| Arrhythmia | 13 | * | * | |
| Chest pain | 2 | * | ||
| Headache | 6 | * | ||
| Fever | 9 | * | * | |
| General malaise | 18 | * | ||
| Convulsion | 5 | |||
| Local Pain | 1 | |||
| Delirium | 2 | |||
| Decreased level of consciousness | 9 | * | ||
| Nausea/vomiting | 16 | * | ||
| Dizziness | 15 | * | ||
| Total (elements) | 203 | 195 | 129 | |
| Total (cases) | 110 | 102 (92.8%) | 59 (53.6%) | |
BP, blood pressure; HR, heart rate; SPO2, peripheral capillary oxygen saturation.
Among the 21 patients in which rehabilitation was discontinued because of decreased oxygen saturation, contrast-enhanced computed tomography (CT) was performed in nine relatively severe cases in whom the use of contrast medium was allowed. Six of these nine patients were diagnosed with pulmonary thromboembolism. All six had undergone orthopedic surgery (joint arthroplasty in five and spinal instrumentation in one), and no thrombus was found in the deep veins of the lower extremity at the time of CT. After confirmation that oxygen saturation could be restored by oxygen administration and the administration of coagulation therapy, rehabilitation was resumed within 1 or 2 days in all six cases. In two patients with chronic heart failure, rehabilitation was discontinued due to chest pain. However, rehabilitation therapy was restarted on the following day because the symptoms disappeared after a short rest with no ischemic signs found on electrocardiography. During the investigation period, no serious adverse events, such as myocardial infarction, fatal arrhythmia, or fatal pulmonary thromboembolism, were reported.
The cancellation rate for cancer rehabilitation patients was higher than that for other disease categories, whereas that for locomotor rehabilitation patients was lower. The reasons for cancellation were also significantly different among disease categories (Table 4). Rehabilitation in cancer patients was most commonly canceled because of general malaise, whereas for locomotor patients, cancellation most commonly resulted from decreased oxygen saturation or blood pressure.
| Locomotor | Stroke | Neuro | Immobility | Cardiovascular | Pulmonary | Cancer | Total | ||
| Blood pressure | 8 | 4 | 5 | 5 | 4 | 2 | 11 | 39 | *P=0.029 |
| Tachycardia, bradycardia, arrythmia | 4 | 4 | 1 | 0 | 6 | 0 | 2 | 17 | |
| O2 Saturation | 8 | 4 | 1 | 1 | 1 | 2 | 2 | 19 | |
| Fever | 0 | 2 | 0 | 0 | 1 | 0 | 1 | 4 | |
| General malaise | 1 | 0 | 0 | 0 | 0 | 1 | 8 | 10 | |
| Nausea, vomiting | 3 | 1 | 0 | 1 | 1 | 0 | 1 | 7 | |
| Others | 3 | 6 | 1 | 1 | 1 | 0 | 2 | 14 | |
| Total | 27 | 21 | 8 | 8 | 14 | 5 | 27 | 110 |
*Chi-squared test to compare the reasons among the categories.
During the study period, 4.9% of the rehabilitation therapies scheduled or prescribed were canceled; of these, 53.6% resulted from changes in vital signs. No serious adverse events occurred during the 6-month investigation period. However, among the 21 patients for whom rehabilitation was discontinued because of decreased oxygen saturation, six had relatively mild symptomatic pulmonary thromboembolisms; nonetheless, rehabilitation could be resumed in 1–2 days.
Although the median ages for each disease category were significantly different (especially, locomotor category patients were young), there were no significant differences between the ages of the non-cancellation and cancellation cases in each category. Therefore, patient age was not directly associated with the cancellation of rehabilitation in this study. The cancellation rates in each disease category were based on its features and reasons of cancellation. The cancellation rates were significantly different among disease categories, with the rate for cancer rehabilitation being the highest. The reasons of cancellation were also significantly different among disease categories. More locomotor category cases were canceled due to poor oxygen saturation, whereas six were canceled due to mild symptomatic pulmonary thromboembolism. Rehabilitation in cancer patients was most commonly canceled due to general malaise.
During this short-term investigation, no serious adverse events were observed; consequently, the necessity of risk management during rehabilitation was reconfirmed. The diseases for which acute rehabilitation are indicated are diverse, and possible complications also differ depending on the disease characteristics and treatment regimen. Therefore, at the time of rehabilitation prescription, the chief physician and the rehabilitation doctor evaluate the patient’s condition and the severity of the disease and examine the necessity and risk of rehabilitation intervention. After considering the criteria for initiating rehabilitation in each disease category, the purposes and goals of rehabilitation are set individually. The types of rehabilitation therapies, the start time, and the exercise intensity are specifically prescribed. Therefore, it is preferable that cancellation of rehabilitation should be judged for each patient individually. On the other hand, one disadvantage of daily safety management is that the cancellation criteria may depend on the medical staff in charge and may therefore differ. In addition to complications peculiar to each disease type, it is also necessary to have some general criteria to correspond to diseases that have no standard diagnosis or newly occurring events.The decision to cancel rehabilitation in this study was made by multiple staff members for each patient, and the reasons for discontinuation varied; however, 92.8% of the canceled cases corresponded to the cancellation criteria of rehabilitation. Since judgment of cancellation of rehabilitation is carried out with the cancellation criteria in mind, it is deemed normal that the reasons for cancellation corresponded to the cancellation criteria in most cases. Indeed, almost all the reasons for cancellation applied in the current study period were defined in the cancellation criteria. Therefore, the judgments of cancellation in this study were similar to the cancellation criteria of rehabilitation.
This study has several limitations. (1) The investigation period was short, covering the 6 months from April to September, and did not include winter or cold seasons. (2) Because this study used records of canceled cases and not those corresponding to the cancellation criteria, there may have been cases in which adverse events were not encountered while implementing rehabilitation therapies although some parameters fell within the cancellation criteria. This study confirms cancellation as a sufficient condition and not as a necessary condition. (3) This study cannot prove the effectiveness of the cancellation criteria proposed by The Japanese Association of Rehabilitation Medicine because the staff are knowledgeable concerning these criteria. As judgments of cancellation of rehabilitation were carried out with the cancellation criteria in mind, it is quite natural that the reasons for cancellation fall under the cancellation criteria in most cases. (4) The chi-squared test was not performed to compare sex or surgical parameters among the seven categories of the non-cancellation and cancellation cases because tests that include a minimum number of cases less than 5 do not have adequate statistical relevance.
This study suggests that medical professionals should be knowledgeable of the cancellation criteria of rehabilitation, and that acute rehabilitation should be performed safely under the control of these cancellation criteria.
We deeply thank Dr. Hidenobu Shigemitsu, Professor of Intensive Care Medicine, Tokyo Medical and Dental University, who kindly checked the back translation of the cancellation criteria of rehabilitation in the “Guidelines for Safety Management and Promotion” of the Japanese Association of Rehabilitation Medicine. We also thank Ms. Masako Akiyama, URA, Research Administration Division, Tokyo Medical and Dental University, who provided the statistical review and comments on our data.
The authors declare that there is no conflict of interest regarding the publication of this article.
