- Email: [email protected]
Early intensive rehabilitation after oral cancer treatment
Accepted Manuscript Early intensive rehabilitation after oral cancer treatment Maximilian Bschorer, Dr. med. Dr. med. dent, Daniel Schneider, Dr. med. Dr. med. dent, Matthias Hennig, Prof. Dr. med, Bernd Frank, Dipl.-Math, Gerhard Schön, Prof. Dr. med. Dr. med. dent, Max Heiland, Prof. Dr. med. Dr. med. dent, Reinhard Bschorer PII:
S1010-5182(18)30105-7
DOI:
10.1016/j.jcms.2018.04.005
Reference:
YJCMS 2947
To appear in:
Journal of Cranio-Maxillo-Facial Surgery
Received Date: 27 August 2017 Revised Date:
21 March 2018
Accepted Date: 4 April 2018
Please cite this article as: Bschorer M, Schneider D, Hennig M, Frank B, Schön G, Heiland M, Bschorer R, Early intensive rehabilitation after oral cancer treatment, Journal of Cranio-Maxillofacial Surgery (2018), doi: 10.1016/j.jcms.2018.04.005. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Early intensive rehabilitation after oral cancer treatment
Maximilian Bschorera; Dr. med. Dr. med. dent. Daniel Schneiderb; Dr. med. Dr. med. dent. Matthias Hennigb; Prof. Dr. med. Bernd Frankc; Dipl.-Math. Gerhard Schönd; Prof. Dr. med. Dr.
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med. dent. Max Heilande; Prof. Dr. med. Dr. med. dent. Reinhard Bschorerb
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Germany
b
Department of Oral and Maxillofacial Surgery, HELIOS Kliniken Schwerin, German
c
Clinic for early rehabilitation and interdisciplinary rehabilitation center, HELIOS Klinik Leezen,
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Germany d
Department of Medical Biometry and Epidemiology, Universitätsklinikum Hamburg-
e
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Eppendorf, Germany
Department of Oral and Maxillofacial Surgery, Charité – Universitätsmedizin Berlin, Berlin,
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Germany.
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Correspondence: Prof. Dr. med. Dr. med. dent. Reinhard Bschorer Department of Oral and Maxillofacial Surgery HELIOS Kliniken Schwerin Wismarsche Straße 393-397 19049 Schwerin (Germany) Tel.: 0385 520-30 80 Fax.: 0385 520-30 77 Head: Prof. Dr. med. Dr. med. dent. Reinhard Bschorer E-mail: [email protected]
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Corresponding Author: Maximilian Bschorer Pfaffenstrasse 10 19055 Schwerin Tel: 0175 8810137 Email: [email protected]
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No funding in forms grants
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a
ACCEPTED MANUSCRIPT Summary
Purpose: The treatment of oral cancer requires an effective rehabilitation strategy
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such as an early intensive rehabilitation (EIR) program. Materials and Methods: The medical records and data of 41 patients who
participated in an EIR program and 20 control group patients were analyzed. These
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patients all underwent surgical resection of the primary tumor followed by
microsurgical reconstruction using free flaps. The length of stay (LOS) at the acute
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care hospital was compared between the two groups. Four indexes were used to evaluate the effectiveness of the EIR program.
Results: EIR patients stayed an average of 11.6 fewer days at the acute care hospital. All indexes showed significant improvements (p < 0.001). The Barthel Index (BI)
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and the Early Intensive Rehabilitation Barthel Index (EIR-BI) improved by 36.0 and 103.6 points, respectively. At discharge, the Bogenhausener Dysphagia Score (BODS) had improved to a score of 11.0 compared to the 13.9 at admission. EIR
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patients had a Work Ability Index (WAI) score of 25.7. Conclusion: Length of stay at the acute care hospital can be reduced using early
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intensive rehabilitation if patients are transferred to an intensive rehabilitation clinic early.
Keywords: rehabilitation; early intensive rehabilitation; oral cancer; Barthel Index; Work Ability Index; Bogenhausener Dysphagia Score
ACCEPTED MANUSCRIPT INTRODUCTION Patients who undergo extensive tumor surgeries followed by free flap reconstructions tend to remain in the hospital for a long period of time. Besides draining important
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hospital resources, the patients’ recovery process can also suffer because of this. In a French study in 2009, oral and pharyngeal cancer patients, who had surgeries
involving microsurgical free flaps, remained in the hospital between 23 and 32 days
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on average, depending on the free flaps transplanted (Girod et al., 2010). For
instance, patients with fibula or latissimus dorsi transplants had a post-surgical
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hospital stays of more than 30 days. An early intensive rehabilitation (EIR) program can allow patients to recover quickly and can potentially improve the outcome of the adjuvant radiation therapy (Kulbersh et al., 2006). If EIR is outsourced to a nearby rehabilitation clinic with medical intensive care capabilities, the length of stay (LOS)
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at the acute care hospital can be significantly reduced.
Head and neck cancer patients who receive reconstructive surgery using free flaps are usually transferred to an intensive care unit (ICU) right after surgery to closely
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monitor the state and perfusion of the flap as well as the standard medical intensive
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care parameters (Ryan et al., 2000). Afterwards, patients are moved to a regular hospital ward and eventually are either discharged or transferred to a different clinic. Transferring these patients to a facility that provides EIR early can accelerate the rehabilitation process while guaranteeing the close monitoring of vital parameters and flap perfusion (Kondo et al., 2017). The EIR program of the Intensive Rehabilitation Center at HELIOS Klinik Leezen in Leezen, Germany, is led by an interdisciplinary team of doctors, physical therapists,
ACCEPTED MANUSCRIPT nurses, speech therapists, and other rehabilitation experts. Important cornerstones of EIR therapy are logopedics, dysphagia diagnostics and therapy, early postoperative oral feeding, caring for tracheostomy tubesm and physiotherapy. In addition, patients
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have access to ventilation therapy (Schwenk et al., 2005). All these treatments are also offered at standard acute care facilities. However, in everyday hospital routine,
the frequency of patients having access to these treatments as well as the duration is
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reduced. For instance, at the acute care hospital, HELIOS Kliniken Schwerin, in
Schwerin, Germany, patients receive 150 to 505 minutes per week of physiotherapy,
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logopedics, manual lymphatic drainage, and respiratory therapy. At the EIR clinic in Leezen, patients are offered a minimum of 2100 minutes of these services every week, and patients can benefit from these programs 7 days per week. There are 12 speech therapists, who work at the 240-bed capacity rehabilitation clinic in Leezen.
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Only 2 speech therapists attend to the patients of the 1500 patient beds at the acute care hospital in Schwerin. This significant discrepancy in staff highlights the greater emphasis that an EIR clinic places on these interdisciplinary rehabilitative treatments
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compared to a regular hospital. Patients are ideally transferred to the EIR facility as soon as the perfusion and drainage of the flap is sufficient. This sort of accelerated
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rehabilitation process has been discussed in studies of colorectal cancer and sarcomas. These authors presented promising results (Kehlet et al., 1999; Michot et al., 2015).
In PubMed, there is an abundance of research on tumor resection, reconstructive surgery, and other forms of therapy for oral cancer patients. However, publications on effective rehabilitation methods for oral cancer patients in the time between surgery and adjuvant radiation treatment are scarce. Our PubMed database search
ACCEPTED MANUSCRIPT revealed a lack of studies on early intensive rehabilitative programs for oral cancer patients, who require extensive tumor resection surgeries followed by free flap microsurgical reconstructions. EIR is generally available only to neurological and
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neurosurgical patients in Germany. This might explain the lack of research papers on EIR for oral and maxillofacial surgery (OMFS) patients. To the best of our
knowledge, we are the only clinic for OMFS with this kind of collaboration
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involving an intensive care rehabilitation center in Germany. The main goal of this study is to evaluate whether outsourcing the postsurgical inpatient rehabilitation
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treatment to an external rehabilitation clinic specialized in EIR can reduce the duration of the hospital stay while also providing an intensified rehabilitation
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treatment for patients after extensive tumor surgeries.
MATERIALS AND METHODS
Patients
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All patients treated at the Department of Oral and Maxillofacial Surgery (OMFS) in HELIOS Kliniken Schwerin between 2006 and 2016 who received major tumor
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resection surgery in the oral and maxillofacial region with microsurgical reconstruction using free flaps were analyzed for the study. Those who were transferred to HELIOS Klinik Leezen, Germany, for EIR made up the treatment group. The collaboration between the OMFS clinic and the intensive rehabilitation clinic started in 2011, but we started collecting data for this study only in 2012. Twenty patients in the control group were selected based on availability of patient records. They were chosen from a group of patients who had diagnosis, surgeries,
ACCEPTED MANUSCRIPT and microsurgical free flaps similar to those of patients in the treatment group. Patients with complications that dramatically extended the hospital stay, and patients who were transferred to different clinics within the hospital before they were
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discharged, were excluded. The control group patients had their surgeries between the years 2006 and 2010 because, starting in 2011, our OMFS clinic and the EIR
facility in Leezen started this collaboration. Therefore, the indexes obtained for the
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EIR group could not be generated for the control group.
Parameters
The LOS at the acute care hospital for both the treatment group and the control group was obtained from the patients’ medical records. The LOS represents the number of
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days the patients spent at the hospital starting at the date of admission right before surgery. It includes the post-surgical stay at an ICU, followed by the stay at a regular hospital ward until patients were either transferred to the EIR facility or discharged
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from the hospital, depending on which study group the patient belonged to. Seven of the 20 control group patients participated in standard inpatient rehabilitation
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programs for tumor patients within 1 year of being discharged from the hospital. Others were later admitted to inpatient radiation therapy. After discharge from either the hospital or the EIR facility, both treatment and the control group patients generally enrolled in outpatient speech therapy and other forms of outpatient rehabilitative programs (1 to 2 times per week). The Barthel Index (BI) is a simple scale of independence that assigns a number to the patients’ ability to perform activities of daily living and mobility (Liu et al., 2015).
ACCEPTED MANUSCRIPT The BI assigns a number from 0 to 100, with the ladder indicating full selfproficiency. The Early Intensive Rehabilitation Barthel Index (EIR-BI) supplements the BI with a section that assesses specific aspects of functional deficits relevant in
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early rehabilitation patients, such as severe dysphagia or an impaired ability to communicate (Schonle, 1995; Rollnik et al., 2016). The EIR-BI ranges from −325 to 100. Both the BI and EIR-BI were obtained at both admission to and discharge from
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the EIR facility.
The Bogenhausener Dysphagia Score (BODS) is used to assess patients’ ability to
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swallow saliva and to consume foods and liquids (Kober et al., 2015). The BODS is a composite of two scores; one of them describes the patient’s ability to swallow saliva, and the other one describes the patient’s ability to consume foods and liquids. Both parts assign a number to the degree of the patient’s dysphagia, ranging from 1
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(normal) to 8 (greatest impairment). The BODS-1 and BODS-2 were both obtained at admission to and at discharge from the EIR facility.
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The Work Ability Index (WAI) assesses the individual’s current ability and future prospects of participating in the work force (Coomer et al., 2013). It consists of seven
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categories of questions, in which patients evaluate their own ability to work, their disability, and their overall outlook on their life. This questionnaire was sent to patients via mail in March 2017 and later followed up with telephone interviews. The BI, the EIR-BI, the WAI, and the BODS, which were all completed by the patient and/or the staff at the rehabilitation clinic, can only serve as a measure to evaluate the effectiveness of this EIR program. The primary goal of this study was to assess whether moving patients to an intensive rehabilitation facility early could
ACCEPTED MANUSCRIPT reduce LOS at the acute care hospital while also providing an adequate recovery process. Whether the recovery process of EIR patients itself was quicker and better
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than that of the control group patients cannot be determined from this study.
Statistical analysis
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All calculations were done using the statistical program R Version 3.3.0. Statistical analysis was performed using an unpaired, two-tailed Student t-test. A value of p <
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0.05 was considered to be indicative of a significant difference between two groups.
RESULTS
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Demographics
The average age of patients in the treatment group (n = 41) was 61.1 years (median = 59.0; standard deviation = 9.7; minimum = 42.0; maximum = 87.0; males, n = 36;
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females, n = 5) at the time of admission to the EIR clinic. The control group’s average age (n = 20) was 54.0 (median = 53.0; standard deviation = 9.7; minimum =
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38.0; maximum = 77.0; males, n = 16; females, n = 4). The patients in both the control group and the treatment group had similar diagnoses, which included squamous cell carcinomas in the oral cavity, oropharynx carcinomas, and tongue carcinomas. The free flaps used in the microsurgical reconstructions were the latissimus dorsi flap, fibula flap, radial forearm flap, lateral upper arm flap, and iliac crest flap (Table 1).
ACCEPTED MANUSCRIPT Hospital length of stay The patients in the control group remained at the acute care hospital, including both the post-surgical ICU and the regular hospital ward, for an average of 34.4 days
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(median = 32.5; standard deviation = 8.7; minimum = 21.0 ; maximum = 50.0). The patients in the EIR group spent an average of 22.8 days (median = 18.0; standard deviation = 11.9; minimum = 8.0; maximum = 52.0) at the hospital before being
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transferred to the EIR clinic. This is an average decrease in LOS at the acute care hospital of 11.6 days (CI 5.6 to 17.6). With a p-value of <0.001, this represents a
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significant decrease (Fig. 1). The LOS of the more recent EIR patients, who were admitted from 2014 to 2016, was 19.2 days (median = 16.5; standard deviation = 10.3; minimum = 8.0; maximum = 52.0). This is a decrease in LOS by 15.2 (CI 9.6
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to 20.8), which is also significant (p < 0.001) (Fig. 2).
Barthel Index and Early Intensive Rehabilitation Barthel Index
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The 41 EIR patients had an average EIR-BI score of -117.4 ± 71.8 at admission. The
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average EIR-BI was -13.8 ± 75.9 at discharge. The EIR-BI score improved by an average of 103.6 (CI -133.2 to -74.0) points over the duration of the patients’ stay at the EIR facility. This effect is significant (p < 0.001) (Fig. 3). The average BI at admission was 32.3 ± 29.0. The BI was 68.3 ± 21.2 at discharge. The Barthel Index improved by an average of 36.0 (CI 28.3 to 43.7). This is also a significant improvement (p < 0.001) (Fig. 4). Patients spent 37 days on average at the EIR facility.
ACCEPTED MANUSCRIPT Bogenhausener Dysphagia Score The mean value of the composite BODS at the start of the EIR program was 13.9 ± 2.5. This score indicates that the patients suffered from severe dysphagia and needed
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intensive monitoring and assistance. At discharge, the score was at 11.0 ± 2.4. The
BODS improved on average by 2.8 (CI 2.2 to 3.5), which is significant (p < 0.001). However, at the time of discharge, the moderate dysphagia (BODS = 11.0) still
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required most patients to enroll in long-term outpatient deglutition training programs
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(Fig. 5).
Work Ability Index
Of 41 EIR patients, 14 had died or were at a hospice at the time of the survey in
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2017. The questionnaires sent to the control group yielded no replies, and 10 of the 20 patients had died. Of the 27 remaining treatment group patients, 19 participated. Three refused to participate, and 5 could not be contacted. The average age of the
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patients at the time they were moved to the rehabilitation clinic was 61 years. Only
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one of the participants was still a member of the workforce. Eleven went into early retirement because of their cancer diagnosis and treatment. Seven of the 41 treatment group patients had already retired at the time of their cancer diagnosis. The average score on the WAI score was 25.7 ± 13.2, which represents a ‘poor’ work ability score (Table 2).
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DISCUSSION Squamous cell carcinoma of the oral cavity is not only one of the most aggressive
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types of cancer, but also very expensive to treat. The lengthy hospital stay, in addition to the extensive surgical procedures, contributes to this significant cost to the health care system as well as the patient (Lang et al., 2004). This new EIR
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program for OMFS patients can fast track the rehabilitation process. Transferring oral cancer patients to an EIR facility can significantly reduce the LOS at the
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hospital.
A large consensus review stated that the reduction in time patients spent at the ICU and hospital ward does not increase the likelihood of complications if certain care criteria, such as monitoring the perfusion of the free flap, are met (Dort et al., 2017).
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Some doctors even suggest that patients could forgo the ICU after surgery altogether if patients can remain under close observation and sufficient care (Mathew et al., 2010). At this time, we can guarantee only optimal initial care for the microsurgical
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flap at an ICU. However, reducing the LOS of patients at the hospital, including the
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ICU, is among the chief goals of this study. A smaller number of patients from the treatment group of our study, which included only patients transferred between the years of 2014 and 2016 (LOS = 19.2 days), were able to leave the acute care hospital sooner than the treatment group, in which patients were transferred to the EIR facility between the years 2012 and 2016 (LOS = 22.8 days). This reduction in LOS in the later years of the study could be due to a learning curve in the initial years of the collaboration between the two clinics. Further optimization of the transfer process and improved coordination between the clinics could further reduce the LOS.
ACCEPTED MANUSCRIPT A major goal of EIR is early mobilization of patients after undergoing tumor resection and free flap reconstructive microsurgery. This has shown favorable results in patients who had surgeries for different kinds of cancer (Vlug et al., 2012). A
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study in France has shown that EIR could cut back on the LOS at hospitals while not negatively impacting the overall outcome of the surgery in patients with soft tissue
sarcoma (Michot et al., 2015). These study authors assert that early mobilization and
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physiotherapy will not increase the likelihood of complications, while potentially
improving and speeding up the recovery process. Some authors suggest that head and
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neck cancers patients who perform swallowing exercises before radiation or chemoradiation treatment could achieve greater quality of life more quickly (Kulbersh et al., 2006). Of the 41 patients in the treatment group, 21 underwent adjuvant radiation treatment. Most patients undergo the adjuvant radiation treatment
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within 4 to 6 weeks. Delaying radiation treatment can increase the likelihood of complications (Ang et al., 2001). EIR could increase the quality of life before radiation treatment, which could, in turn, improve the overall long-term results.
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Further research studies should investigate whether an improved quality of life and patient autonomy at the time of adjuvant radiation could improve the overall
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outcome of the cancer treatment. EIR-BI, the BI, and the BODS scores were not obtainable for the control group of our study. Thus, we cannot definitely state that EIR at an intensive rehabilitation facility helps patients to recover more quickly than they would at an acute care hospital. The average BI of the treatment group improved by 36.0 points, from a score of 32.3 at admission to 68.3 at discharge from the EIR facility. The rehabilitation program of Tokushima University hospital in Japan showed an improvement of the BI from 21.4
ACCEPTED MANUSCRIPT to 42.5 for stroke patients (Nakao et al., 2010). A Turkish study on the effectiveness of their early rehabilitation program of brain tumor and traumatic brain injury showed improvements of 5 and 12.5 points, respectively (Bilgin et al., 2014). The BI
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has not been used to assess the effectiveness of rehabilitation in improving oral cancer patients’ activities of daily living, but comparing the results to other
rehabilitation of patients with different severe diseases suggests that EIR for oral
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cancer patients may be effective.
Oral cancer is often associated with lower socioeconomic status, alcoholism,
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smoking, unemployment, and early retirement (Kjaer et al., 2013). This further complicates rehabilitation in patients and reintegrating them into the work force (Handschel et al., 2013). Only one of the EIR group patients who completed the WAI questionnaire was still an active member of the work force. An Irish study of 583
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head and neck cancer patients reported that 59% of patients returned to work after taking an average break from work of 9 months. Other studies on work reintegration of cancer patients show similar results (Pearce et al., 2015). However, the average
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age of patients who participated in the Irish survey was 52 years, which is
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significantly younger than the 61 years of the patients in the treatment group of this study. The 9-year age difference could explain the decreased postsurgical workforce participation results of the patients in this study. An average score of 25.7 on the WAI questionnaire represents a value that is associated with inadequate work ability and workers likely entering disability retirement (Roelen et al., 2014). New treatment protocols such as 3D reconstruction, including primary dental implant surgery, may improve the overall work ability of OMFS tumor patients in the future.
ACCEPTED MANUSCRIPT CONCLUSION Introducing early intensive rehabilitation to the postoperative treatment of head and neck cancer patients who undergo extensive tumor resection and reconstructive
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surger, can reduce the length of stay in the hospital. We propose that clinics for OMFS, which specialize in free flap microsurgery, should consider collaborations
with intensive rehabilitation clinics in the vicinity. The patients, the clinics, and the
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health care system as a whole could benefit from this.
ACCEPTED MANUSCRIPT Conflict of interest
Funding
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There was no source of funding for this study.
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The authors declare that they have no conflict of interest.
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Ethical approval
Ethical approval was granted by the regional ethical committee of the Medical University in Rostock, Germany.
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Patient consent
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All included patients signed an informed consent form before participating.
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ACCEPTED MANUSCRIPT Figure 1. Length of stay (days) at the acute care hospital of the early intensive rehabilitation (EIR) (treatment) group (2012-2016) and the control group (20062010).
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Figure 2. Length of stay (days) at the acute care hospital of the early intensive
rehabilitation (EIR) (treatment) group (2014-2016) and the control group (2006-
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2010).
Figure 3. Early Intensive Rehabilitation Barthel Index of early intensive
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rehabilitation (EIR) patients at the time of admission to and discharge from the EIR facility.
Figure 4. Barthel Index of early intensive rehabilitation (EIR) patients at the time of admission to and discharge from the EIR facility.
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Figure 5. Bogenhausener Dysphagia Score of early intensive rehabilitation (EIR)
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patients at the time of admission to and discharge from the EIR facility.
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Total number of oral cancer patients (n) Mean age (yr) Male Female T1 T2 T3 T4 Total number Radial forearm Latissimus dorsi muscle Fibula Lateral upper arm Iliac crest
Control group 20
61.1
54.0
36 5 12 4 6 19 41 15 9 7 7 3
16 4 2 8 5 5 20 12 7 1
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Gender
Treatment group 41
Staging (n)
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Microsurgical free flaps (n)
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Table 1. Tumor staging and microsurgical free flaps
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n (%) 33* (100) 14 (42) 19 (58) 7 (21) 11 (33) 1 (3) 25.7
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WAI questionnaire for EIR patient group Total patients Deceased or at hospice at time of WAI survey Participants Retired before oral cancer treatment Early retirement after oral cancer treatment Members of the workforce Average WAI score out of 49
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*Five patients could not be contacted and three refused to participate.
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Table 2. Work Ability Index (WAI)
MANUSCRIPT Δ 11.6ACCEPTED (CI 5.6, 17.6); p-value <0.001
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42
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35
14 7
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21
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28
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Length of stay at the hospital [days]
49
0
mean (n)
control 34.4 (20)
treatment 22.8 (41)
MANUSCRIPT Δ 15.2ACCEPTED (CI 9.6, 20.8); p-value <0.001
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42
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35
14 7
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21
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28
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Length of stay at the hospital [days]
49
0
mean (n)
control 34.4 (20)
treatment 19.2 (32)
MANUSCRIPT Δ -103.6ACCEPTED (CI -133.2, -74.0); p-value <0.001
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0
-200
mean (n)
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-100
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Early Intensive Rehabilitation Barthel Index
100
Admission -117.4 (41)
Discharge -13.8 (41)
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100
20
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40
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60
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Barthel Index
80
0
mean (n)
Admission 32.3 (41)
Discharge 68.3 (41)
ACCEPTED MANUSCRIPT Δ 2.8 (CI 2.2, 3.5); p-value <0.001
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14
8
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10
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12
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Bogenhausener Dysphagia Score
16
6
mean (n)
Admission 13.9 (41)
Discharge 11.0 (41)
S1010-5182(18)30105-7
DOI:
10.1016/j.jcms.2018.04.005
Reference:
YJCMS 2947
To appear in:
Journal of Cranio-Maxillo-Facial Surgery
Received Date: 27 August 2017 Revised Date:
21 March 2018
Accepted Date: 4 April 2018
Please cite this article as: Bschorer M, Schneider D, Hennig M, Frank B, Schön G, Heiland M, Bschorer R, Early intensive rehabilitation after oral cancer treatment, Journal of Cranio-Maxillofacial Surgery (2018), doi: 10.1016/j.jcms.2018.04.005. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Early intensive rehabilitation after oral cancer treatment
Maximilian Bschorera; Dr. med. Dr. med. dent. Daniel Schneiderb; Dr. med. Dr. med. dent. Matthias Hennigb; Prof. Dr. med. Bernd Frankc; Dipl.-Math. Gerhard Schönd; Prof. Dr. med. Dr.
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med. dent. Max Heilande; Prof. Dr. med. Dr. med. dent. Reinhard Bschorerb
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Germany
b
Department of Oral and Maxillofacial Surgery, HELIOS Kliniken Schwerin, German
c
Clinic for early rehabilitation and interdisciplinary rehabilitation center, HELIOS Klinik Leezen,
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a
Germany d
Department of Medical Biometry and Epidemiology, Universitätsklinikum Hamburg-
e
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Eppendorf, Germany
Department of Oral and Maxillofacial Surgery, Charité – Universitätsmedizin Berlin, Berlin,
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Germany.
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Correspondence: Prof. Dr. med. Dr. med. dent. Reinhard Bschorer Department of Oral and Maxillofacial Surgery HELIOS Kliniken Schwerin Wismarsche Straße 393-397 19049 Schwerin (Germany) Tel.: 0385 520-30 80 Fax.: 0385 520-30 77 Head: Prof. Dr. med. Dr. med. dent. Reinhard Bschorer E-mail: [email protected]
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Corresponding Author: Maximilian Bschorer Pfaffenstrasse 10 19055 Schwerin Tel: 0175 8810137 Email: [email protected]
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No funding in forms grants
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a
ACCEPTED MANUSCRIPT Summary
Purpose: The treatment of oral cancer requires an effective rehabilitation strategy
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such as an early intensive rehabilitation (EIR) program. Materials and Methods: The medical records and data of 41 patients who
participated in an EIR program and 20 control group patients were analyzed. These
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patients all underwent surgical resection of the primary tumor followed by
microsurgical reconstruction using free flaps. The length of stay (LOS) at the acute
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care hospital was compared between the two groups. Four indexes were used to evaluate the effectiveness of the EIR program.
Results: EIR patients stayed an average of 11.6 fewer days at the acute care hospital. All indexes showed significant improvements (p < 0.001). The Barthel Index (BI)
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and the Early Intensive Rehabilitation Barthel Index (EIR-BI) improved by 36.0 and 103.6 points, respectively. At discharge, the Bogenhausener Dysphagia Score (BODS) had improved to a score of 11.0 compared to the 13.9 at admission. EIR
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patients had a Work Ability Index (WAI) score of 25.7. Conclusion: Length of stay at the acute care hospital can be reduced using early
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intensive rehabilitation if patients are transferred to an intensive rehabilitation clinic early.
Keywords: rehabilitation; early intensive rehabilitation; oral cancer; Barthel Index; Work Ability Index; Bogenhausener Dysphagia Score
ACCEPTED MANUSCRIPT INTRODUCTION Patients who undergo extensive tumor surgeries followed by free flap reconstructions tend to remain in the hospital for a long period of time. Besides draining important
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hospital resources, the patients’ recovery process can also suffer because of this. In a French study in 2009, oral and pharyngeal cancer patients, who had surgeries
involving microsurgical free flaps, remained in the hospital between 23 and 32 days
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on average, depending on the free flaps transplanted (Girod et al., 2010). For
instance, patients with fibula or latissimus dorsi transplants had a post-surgical
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hospital stays of more than 30 days. An early intensive rehabilitation (EIR) program can allow patients to recover quickly and can potentially improve the outcome of the adjuvant radiation therapy (Kulbersh et al., 2006). If EIR is outsourced to a nearby rehabilitation clinic with medical intensive care capabilities, the length of stay (LOS)
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at the acute care hospital can be significantly reduced.
Head and neck cancer patients who receive reconstructive surgery using free flaps are usually transferred to an intensive care unit (ICU) right after surgery to closely
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monitor the state and perfusion of the flap as well as the standard medical intensive
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care parameters (Ryan et al., 2000). Afterwards, patients are moved to a regular hospital ward and eventually are either discharged or transferred to a different clinic. Transferring these patients to a facility that provides EIR early can accelerate the rehabilitation process while guaranteeing the close monitoring of vital parameters and flap perfusion (Kondo et al., 2017). The EIR program of the Intensive Rehabilitation Center at HELIOS Klinik Leezen in Leezen, Germany, is led by an interdisciplinary team of doctors, physical therapists,
ACCEPTED MANUSCRIPT nurses, speech therapists, and other rehabilitation experts. Important cornerstones of EIR therapy are logopedics, dysphagia diagnostics and therapy, early postoperative oral feeding, caring for tracheostomy tubesm and physiotherapy. In addition, patients
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have access to ventilation therapy (Schwenk et al., 2005). All these treatments are also offered at standard acute care facilities. However, in everyday hospital routine,
the frequency of patients having access to these treatments as well as the duration is
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reduced. For instance, at the acute care hospital, HELIOS Kliniken Schwerin, in
Schwerin, Germany, patients receive 150 to 505 minutes per week of physiotherapy,
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logopedics, manual lymphatic drainage, and respiratory therapy. At the EIR clinic in Leezen, patients are offered a minimum of 2100 minutes of these services every week, and patients can benefit from these programs 7 days per week. There are 12 speech therapists, who work at the 240-bed capacity rehabilitation clinic in Leezen.
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Only 2 speech therapists attend to the patients of the 1500 patient beds at the acute care hospital in Schwerin. This significant discrepancy in staff highlights the greater emphasis that an EIR clinic places on these interdisciplinary rehabilitative treatments
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compared to a regular hospital. Patients are ideally transferred to the EIR facility as soon as the perfusion and drainage of the flap is sufficient. This sort of accelerated
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rehabilitation process has been discussed in studies of colorectal cancer and sarcomas. These authors presented promising results (Kehlet et al., 1999; Michot et al., 2015).
In PubMed, there is an abundance of research on tumor resection, reconstructive surgery, and other forms of therapy for oral cancer patients. However, publications on effective rehabilitation methods for oral cancer patients in the time between surgery and adjuvant radiation treatment are scarce. Our PubMed database search
ACCEPTED MANUSCRIPT revealed a lack of studies on early intensive rehabilitative programs for oral cancer patients, who require extensive tumor resection surgeries followed by free flap microsurgical reconstructions. EIR is generally available only to neurological and
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neurosurgical patients in Germany. This might explain the lack of research papers on EIR for oral and maxillofacial surgery (OMFS) patients. To the best of our
knowledge, we are the only clinic for OMFS with this kind of collaboration
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involving an intensive care rehabilitation center in Germany. The main goal of this study is to evaluate whether outsourcing the postsurgical inpatient rehabilitation
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treatment to an external rehabilitation clinic specialized in EIR can reduce the duration of the hospital stay while also providing an intensified rehabilitation
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treatment for patients after extensive tumor surgeries.
MATERIALS AND METHODS
Patients
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All patients treated at the Department of Oral and Maxillofacial Surgery (OMFS) in HELIOS Kliniken Schwerin between 2006 and 2016 who received major tumor
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resection surgery in the oral and maxillofacial region with microsurgical reconstruction using free flaps were analyzed for the study. Those who were transferred to HELIOS Klinik Leezen, Germany, for EIR made up the treatment group. The collaboration between the OMFS clinic and the intensive rehabilitation clinic started in 2011, but we started collecting data for this study only in 2012. Twenty patients in the control group were selected based on availability of patient records. They were chosen from a group of patients who had diagnosis, surgeries,
ACCEPTED MANUSCRIPT and microsurgical free flaps similar to those of patients in the treatment group. Patients with complications that dramatically extended the hospital stay, and patients who were transferred to different clinics within the hospital before they were
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discharged, were excluded. The control group patients had their surgeries between the years 2006 and 2010 because, starting in 2011, our OMFS clinic and the EIR
facility in Leezen started this collaboration. Therefore, the indexes obtained for the
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EIR group could not be generated for the control group.
Parameters
The LOS at the acute care hospital for both the treatment group and the control group was obtained from the patients’ medical records. The LOS represents the number of
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days the patients spent at the hospital starting at the date of admission right before surgery. It includes the post-surgical stay at an ICU, followed by the stay at a regular hospital ward until patients were either transferred to the EIR facility or discharged
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from the hospital, depending on which study group the patient belonged to. Seven of the 20 control group patients participated in standard inpatient rehabilitation
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programs for tumor patients within 1 year of being discharged from the hospital. Others were later admitted to inpatient radiation therapy. After discharge from either the hospital or the EIR facility, both treatment and the control group patients generally enrolled in outpatient speech therapy and other forms of outpatient rehabilitative programs (1 to 2 times per week). The Barthel Index (BI) is a simple scale of independence that assigns a number to the patients’ ability to perform activities of daily living and mobility (Liu et al., 2015).
ACCEPTED MANUSCRIPT The BI assigns a number from 0 to 100, with the ladder indicating full selfproficiency. The Early Intensive Rehabilitation Barthel Index (EIR-BI) supplements the BI with a section that assesses specific aspects of functional deficits relevant in
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early rehabilitation patients, such as severe dysphagia or an impaired ability to communicate (Schonle, 1995; Rollnik et al., 2016). The EIR-BI ranges from −325 to 100. Both the BI and EIR-BI were obtained at both admission to and discharge from
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the EIR facility.
The Bogenhausener Dysphagia Score (BODS) is used to assess patients’ ability to
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swallow saliva and to consume foods and liquids (Kober et al., 2015). The BODS is a composite of two scores; one of them describes the patient’s ability to swallow saliva, and the other one describes the patient’s ability to consume foods and liquids. Both parts assign a number to the degree of the patient’s dysphagia, ranging from 1
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(normal) to 8 (greatest impairment). The BODS-1 and BODS-2 were both obtained at admission to and at discharge from the EIR facility.
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The Work Ability Index (WAI) assesses the individual’s current ability and future prospects of participating in the work force (Coomer et al., 2013). It consists of seven
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categories of questions, in which patients evaluate their own ability to work, their disability, and their overall outlook on their life. This questionnaire was sent to patients via mail in March 2017 and later followed up with telephone interviews. The BI, the EIR-BI, the WAI, and the BODS, which were all completed by the patient and/or the staff at the rehabilitation clinic, can only serve as a measure to evaluate the effectiveness of this EIR program. The primary goal of this study was to assess whether moving patients to an intensive rehabilitation facility early could
ACCEPTED MANUSCRIPT reduce LOS at the acute care hospital while also providing an adequate recovery process. Whether the recovery process of EIR patients itself was quicker and better
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than that of the control group patients cannot be determined from this study.
Statistical analysis
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All calculations were done using the statistical program R Version 3.3.0. Statistical analysis was performed using an unpaired, two-tailed Student t-test. A value of p <
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0.05 was considered to be indicative of a significant difference between two groups.
RESULTS
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Demographics
The average age of patients in the treatment group (n = 41) was 61.1 years (median = 59.0; standard deviation = 9.7; minimum = 42.0; maximum = 87.0; males, n = 36;
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females, n = 5) at the time of admission to the EIR clinic. The control group’s average age (n = 20) was 54.0 (median = 53.0; standard deviation = 9.7; minimum =
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38.0; maximum = 77.0; males, n = 16; females, n = 4). The patients in both the control group and the treatment group had similar diagnoses, which included squamous cell carcinomas in the oral cavity, oropharynx carcinomas, and tongue carcinomas. The free flaps used in the microsurgical reconstructions were the latissimus dorsi flap, fibula flap, radial forearm flap, lateral upper arm flap, and iliac crest flap (Table 1).
ACCEPTED MANUSCRIPT Hospital length of stay The patients in the control group remained at the acute care hospital, including both the post-surgical ICU and the regular hospital ward, for an average of 34.4 days
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(median = 32.5; standard deviation = 8.7; minimum = 21.0 ; maximum = 50.0). The patients in the EIR group spent an average of 22.8 days (median = 18.0; standard deviation = 11.9; minimum = 8.0; maximum = 52.0) at the hospital before being
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transferred to the EIR clinic. This is an average decrease in LOS at the acute care hospital of 11.6 days (CI 5.6 to 17.6). With a p-value of <0.001, this represents a
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significant decrease (Fig. 1). The LOS of the more recent EIR patients, who were admitted from 2014 to 2016, was 19.2 days (median = 16.5; standard deviation = 10.3; minimum = 8.0; maximum = 52.0). This is a decrease in LOS by 15.2 (CI 9.6
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to 20.8), which is also significant (p < 0.001) (Fig. 2).
Barthel Index and Early Intensive Rehabilitation Barthel Index
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The 41 EIR patients had an average EIR-BI score of -117.4 ± 71.8 at admission. The
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average EIR-BI was -13.8 ± 75.9 at discharge. The EIR-BI score improved by an average of 103.6 (CI -133.2 to -74.0) points over the duration of the patients’ stay at the EIR facility. This effect is significant (p < 0.001) (Fig. 3). The average BI at admission was 32.3 ± 29.0. The BI was 68.3 ± 21.2 at discharge. The Barthel Index improved by an average of 36.0 (CI 28.3 to 43.7). This is also a significant improvement (p < 0.001) (Fig. 4). Patients spent 37 days on average at the EIR facility.
ACCEPTED MANUSCRIPT Bogenhausener Dysphagia Score The mean value of the composite BODS at the start of the EIR program was 13.9 ± 2.5. This score indicates that the patients suffered from severe dysphagia and needed
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intensive monitoring and assistance. At discharge, the score was at 11.0 ± 2.4. The
BODS improved on average by 2.8 (CI 2.2 to 3.5), which is significant (p < 0.001). However, at the time of discharge, the moderate dysphagia (BODS = 11.0) still
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required most patients to enroll in long-term outpatient deglutition training programs
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(Fig. 5).
Work Ability Index
Of 41 EIR patients, 14 had died or were at a hospice at the time of the survey in
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2017. The questionnaires sent to the control group yielded no replies, and 10 of the 20 patients had died. Of the 27 remaining treatment group patients, 19 participated. Three refused to participate, and 5 could not be contacted. The average age of the
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patients at the time they were moved to the rehabilitation clinic was 61 years. Only
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one of the participants was still a member of the workforce. Eleven went into early retirement because of their cancer diagnosis and treatment. Seven of the 41 treatment group patients had already retired at the time of their cancer diagnosis. The average score on the WAI score was 25.7 ± 13.2, which represents a ‘poor’ work ability score (Table 2).
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DISCUSSION Squamous cell carcinoma of the oral cavity is not only one of the most aggressive
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types of cancer, but also very expensive to treat. The lengthy hospital stay, in addition to the extensive surgical procedures, contributes to this significant cost to the health care system as well as the patient (Lang et al., 2004). This new EIR
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program for OMFS patients can fast track the rehabilitation process. Transferring oral cancer patients to an EIR facility can significantly reduce the LOS at the
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hospital.
A large consensus review stated that the reduction in time patients spent at the ICU and hospital ward does not increase the likelihood of complications if certain care criteria, such as monitoring the perfusion of the free flap, are met (Dort et al., 2017).
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Some doctors even suggest that patients could forgo the ICU after surgery altogether if patients can remain under close observation and sufficient care (Mathew et al., 2010). At this time, we can guarantee only optimal initial care for the microsurgical
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flap at an ICU. However, reducing the LOS of patients at the hospital, including the
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ICU, is among the chief goals of this study. A smaller number of patients from the treatment group of our study, which included only patients transferred between the years of 2014 and 2016 (LOS = 19.2 days), were able to leave the acute care hospital sooner than the treatment group, in which patients were transferred to the EIR facility between the years 2012 and 2016 (LOS = 22.8 days). This reduction in LOS in the later years of the study could be due to a learning curve in the initial years of the collaboration between the two clinics. Further optimization of the transfer process and improved coordination between the clinics could further reduce the LOS.
ACCEPTED MANUSCRIPT A major goal of EIR is early mobilization of patients after undergoing tumor resection and free flap reconstructive microsurgery. This has shown favorable results in patients who had surgeries for different kinds of cancer (Vlug et al., 2012). A
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study in France has shown that EIR could cut back on the LOS at hospitals while not negatively impacting the overall outcome of the surgery in patients with soft tissue
sarcoma (Michot et al., 2015). These study authors assert that early mobilization and
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physiotherapy will not increase the likelihood of complications, while potentially
improving and speeding up the recovery process. Some authors suggest that head and
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neck cancers patients who perform swallowing exercises before radiation or chemoradiation treatment could achieve greater quality of life more quickly (Kulbersh et al., 2006). Of the 41 patients in the treatment group, 21 underwent adjuvant radiation treatment. Most patients undergo the adjuvant radiation treatment
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within 4 to 6 weeks. Delaying radiation treatment can increase the likelihood of complications (Ang et al., 2001). EIR could increase the quality of life before radiation treatment, which could, in turn, improve the overall long-term results.
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Further research studies should investigate whether an improved quality of life and patient autonomy at the time of adjuvant radiation could improve the overall
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outcome of the cancer treatment. EIR-BI, the BI, and the BODS scores were not obtainable for the control group of our study. Thus, we cannot definitely state that EIR at an intensive rehabilitation facility helps patients to recover more quickly than they would at an acute care hospital. The average BI of the treatment group improved by 36.0 points, from a score of 32.3 at admission to 68.3 at discharge from the EIR facility. The rehabilitation program of Tokushima University hospital in Japan showed an improvement of the BI from 21.4
ACCEPTED MANUSCRIPT to 42.5 for stroke patients (Nakao et al., 2010). A Turkish study on the effectiveness of their early rehabilitation program of brain tumor and traumatic brain injury showed improvements of 5 and 12.5 points, respectively (Bilgin et al., 2014). The BI
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has not been used to assess the effectiveness of rehabilitation in improving oral cancer patients’ activities of daily living, but comparing the results to other
rehabilitation of patients with different severe diseases suggests that EIR for oral
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cancer patients may be effective.
Oral cancer is often associated with lower socioeconomic status, alcoholism,
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smoking, unemployment, and early retirement (Kjaer et al., 2013). This further complicates rehabilitation in patients and reintegrating them into the work force (Handschel et al., 2013). Only one of the EIR group patients who completed the WAI questionnaire was still an active member of the work force. An Irish study of 583
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head and neck cancer patients reported that 59% of patients returned to work after taking an average break from work of 9 months. Other studies on work reintegration of cancer patients show similar results (Pearce et al., 2015). However, the average
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age of patients who participated in the Irish survey was 52 years, which is
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significantly younger than the 61 years of the patients in the treatment group of this study. The 9-year age difference could explain the decreased postsurgical workforce participation results of the patients in this study. An average score of 25.7 on the WAI questionnaire represents a value that is associated with inadequate work ability and workers likely entering disability retirement (Roelen et al., 2014). New treatment protocols such as 3D reconstruction, including primary dental implant surgery, may improve the overall work ability of OMFS tumor patients in the future.
ACCEPTED MANUSCRIPT CONCLUSION Introducing early intensive rehabilitation to the postoperative treatment of head and neck cancer patients who undergo extensive tumor resection and reconstructive
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surger, can reduce the length of stay in the hospital. We propose that clinics for OMFS, which specialize in free flap microsurgery, should consider collaborations
with intensive rehabilitation clinics in the vicinity. The patients, the clinics, and the
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health care system as a whole could benefit from this.
ACCEPTED MANUSCRIPT Conflict of interest
Funding
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There was no source of funding for this study.
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The authors declare that they have no conflict of interest.
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Ethical approval
Ethical approval was granted by the regional ethical committee of the Medical University in Rostock, Germany.
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Patient consent
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All included patients signed an informed consent form before participating.
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ACCEPTED MANUSCRIPT Figure 1. Length of stay (days) at the acute care hospital of the early intensive rehabilitation (EIR) (treatment) group (2012-2016) and the control group (20062010).
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Figure 2. Length of stay (days) at the acute care hospital of the early intensive
rehabilitation (EIR) (treatment) group (2014-2016) and the control group (2006-
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2010).
Figure 3. Early Intensive Rehabilitation Barthel Index of early intensive
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rehabilitation (EIR) patients at the time of admission to and discharge from the EIR facility.
Figure 4. Barthel Index of early intensive rehabilitation (EIR) patients at the time of admission to and discharge from the EIR facility.
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Figure 5. Bogenhausener Dysphagia Score of early intensive rehabilitation (EIR)
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patients at the time of admission to and discharge from the EIR facility.
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Total number of oral cancer patients (n) Mean age (yr) Male Female T1 T2 T3 T4 Total number Radial forearm Latissimus dorsi muscle Fibula Lateral upper arm Iliac crest
Control group 20
61.1
54.0
36 5 12 4 6 19 41 15 9 7 7 3
16 4 2 8 5 5 20 12 7 1
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Gender
Treatment group 41
Staging (n)
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Microsurgical free flaps (n)
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Table 1. Tumor staging and microsurgical free flaps
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n (%) 33* (100) 14 (42) 19 (58) 7 (21) 11 (33) 1 (3) 25.7
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WAI questionnaire for EIR patient group Total patients Deceased or at hospice at time of WAI survey Participants Retired before oral cancer treatment Early retirement after oral cancer treatment Members of the workforce Average WAI score out of 49
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*Five patients could not be contacted and three refused to participate.
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M AN U
Table 2. Work Ability Index (WAI)
MANUSCRIPT Δ 11.6ACCEPTED (CI 5.6, 17.6); p-value <0.001
RI PT SC
42
M AN U
35
14 7
EP
21
TE D
28
AC C
Length of stay at the hospital [days]
49
0
mean (n)
control 34.4 (20)
treatment 22.8 (41)
MANUSCRIPT Δ 15.2ACCEPTED (CI 9.6, 20.8); p-value <0.001
RI PT SC
42
M AN U
35
14 7
EP
21
TE D
28
AC C
Length of stay at the hospital [days]
49
0
mean (n)
control 34.4 (20)
treatment 19.2 (32)
MANUSCRIPT Δ -103.6ACCEPTED (CI -133.2, -74.0); p-value <0.001
RI PT M AN U
SC
0
-200
mean (n)
EP
TE D
-100
AC C
Early Intensive Rehabilitation Barthel Index
100
Admission -117.4 (41)
Discharge -13.8 (41)
MANUSCRIPT Δ -36.0ACCEPTED (CI -43.7, -28.3); p-value <0.001
RI PT
100
20
SC TE D EP
40
M AN U
60
AC C
Barthel Index
80
0
mean (n)
Admission 32.3 (41)
Discharge 68.3 (41)
ACCEPTED MANUSCRIPT Δ 2.8 (CI 2.2, 3.5); p-value <0.001
RI PT SC
14
8
TE D EP
10
M AN U
12
AC C
Bogenhausener Dysphagia Score
16
6
mean (n)
Admission 13.9 (41)
Discharge 11.0 (41)