Risk Constellation Of Hospital Acquired Pressure Injuries In Patients With A Spinal Cord Injury/ Disorder - Focus On Time Since Spinal Cord Injury/ Disorder And Patients’ Age

doi:10.21203/rs.3.rs-2125593/v1

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Risk Constellation Of Hospital Acquired Pressure Injuries In Patients With A Spinal Cord Injury/ Disorder - Focus On Time Since Spinal Cord Injury/ Disorder And Patients’ Age

https://doi.org/10.21203/rs.3.rs-2125593/v1

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published 05 Jul, 2023

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Study Design: Prospective cohort study.

Objectives: The aim of this study was to evaluate how time since spinal cord injury/disorder (SCI/D) and patients’ age influence risk constellation for hospital acquired pressure injuries (HAPI) in patients with a SCI/D.

Setting: Acute care and rehabilitation clinic specialized in SCI/D.

Methods: We collected patients’ characteristics and 85 risk factors for HAPI development in adults with SCI/D with at least one HAPI during their inpatient stay between August 2018 and December 2019. We analyzed patients’ characteristics and HAPI risk factors using descriptive statistics according to time since SCI/D (<1 year, 1-15 years, >15 years) and patients’ age (18-35 years, 35-65 years, >65 years).

Result: We identified 182 HAPI in 96 patients. Comparing patients with SCI/D <1 year with the other groups, autonomic dysreflexia (p<0.001), abnormal body temperature (p=0.001), hypertensive episode (p=0.005), and pneumonia (p<0.001) occurred more frequently; mean hemoglobin (p<0.001), albumin (p=0.002) and vitamin D levels (p=0.013) were significantly lower, and patients with time since SCI/D <1 year scored fewer points (10-12) on the Braden Scale (p<0.001). Comparing groups per patients’ age, only the SCIPUS score was higher in patients >65 years compared to the other two groups (p=0.002).

Conclusion: Different risk factor constellation seem to be underlying HAPI development with more differences in patients time since SCI/D than patients’ age. Awareness of these differences in risk factor constellation depending on time since SCI/D in these patients might lead to different HAPI prevention strategies.

Health sciences/Risk factors

Health sciences/Health care/Disease prevention/Preventive medicine

Spinal Cord Injuries

pressure ulcers

complication

preventive measures

time since injury

patients’ age

ageing

rehabilitation

Recognizing factors leading to complications and changing clinical practice to preventing these complications in people living with a chronic health condition is one of the most relevant aspects to achieving and maintaining a high quality of live. Especially in patients with a spinal cord injury and disorder (SCI/D), a patient group at increased risk of suffering from multiple acute and long-term secondary health conditions, preventing complications is fundamental for patient care [1]. Pressure injuries (PI) are one of the most common reported complications alongside urinary tract infection (UTI), autonomic dysreflexia, respiratory complications, such as pneumonia and respiratory failure, spasticity, pain syndrome, osteoporosis, and fractures [2, 3]. PI can have a significant impact on the individual’s health and functioning and can negatively affect the individual’s quality of life and social participation [4, 5]. PI may extend lengths of hospital stay, thus significantly increasing the burden on the health-care system [6]. Studies showed that one in three patients with SCI/D develops PI over their lifespan [7]. Identifying risk factors that may contribute to complications, such as preventing the development of PI in patients with SCI/D, is critical for improving survival, fostering community participation and enhancing quality of life [3]. Most importantly, preventing and avoiding complications is more cost-effective than treating complications [8, 9].

The risk constellation of PI might change in different situations and living constellations. Therefore, detailed situational related analyses are needed. Hospital acquired pressure injuries (HAPI) are PI, that occur in the special setting of a hospital including acute care and rehabilitation [10, 11]. HAPI occur in 29.7–49.2% of patients with a SCI/D [10–12]. In comparison to PI, which occur in an outpatient setting and are thus poorly documented, HAPI occur in a setting where risk factors leading to the development are documented in a standardized fashion. Thus, analyzing factors contributing to HAPI development can be used to identify patient characteristics and medical data for risk stratification.

A first step to developing prevention strategies for HAPI is to identify high-risk SCI/D patients. Multiple risk scales like Braden [13], Waterlow [14], or SCIPUS Scale [15] exist with the aim to identify patients at risk for PI/HAPI development in general and in the SCI/D population in particular. However, these scales yield no reliable prediction of PI/HAPI development [16]. As there is no high-quality evidence that the use of a risk assessment tool reduces the incidence of new onset PI/HAPI [17], it is crucial to identify high risk constellation of risk factors. More than 200 risk factors for developing a PI/HAPI were identified for individuals with SCI/D [18]. However, no reliable model to identify the individual risk of a patient to develop a HAPI exists. Most importantly, no deeper understanding of how risk factors influence each other has been obtained. One of the most influential factors of HAPI development is time since SCI/D and patients’ age [10, 19, 20]. Najmanova et al. analyzed 85 previously identified risk factors for HAPI development in patients with SCI/D during their first rehabilitation. They identified 15 significant and/or clinically relevant risk factors that are different between patients who developed and who did not develop HAPI [21]. So far, it is unknown whether these risk factors change with time since SCI/D or patients’ age. However, this information is crucial to develop strategies for HAPI prevention.

To further deepen our knowledge of changing risk factor constellations of HAPI and therefore improve the management of reducing complications, the aim of this study was to evaluate how known risk factors for HAPI development are influenced by time since SCI/D and patients’ age. We hypothesize that different risk factor constellation for HAPI development exist for time since SCI/D and patients’ age.

Study design and setting

This is a prospective, observational, cohort study of 96 patients with SCI/D who developed at least one HAPI during their inpatient stay at a specialized acute and rehabilitation clinic in Switzerland. Reason for admission was among others primary rehabilitation, re-rehabilitation, elective surgery of shoulder, hand, or spine, urologic intervention, and PI treatment. HAPI prevention and treatment followed the clinic-specific TIMES (tissue, infection, moisture, edge, surrounding skin) concept [22] and the modified Basel-Decubitus concept [23, 24]. The reporting of this observational study followed the STROBE criteria [25].

Cohort and observation period

This study used data of a quality assurance project where the occurrence of HAPI was documented and collected in a standardized manner (Supplement material document 1). Full details of this studies’ rationale and design have been published elsewhere [21]. In brief, for this study we included patients who developed at least one HAPI and were part of the above-mentioned quality assurance project between August 1st, 2018, and December 31st, 2019 (Fig. 1– Flow chart). Exclusion criteria were age < 18 years, primary disease other than SCI/D, and documented rejection of further use of patients’ data. During the observational period, patients’ characteristics, and risk factors for HAPI development were prospectively collected and retrospectively complemented. Data collection was concluded on December 31st, 2019 and censored for those still hospitalized on December 31st, 2019. The study was approved by the Ethical Committee Northwest and Central Switzerland (protocol code EKNZ ID 2019–02179).

Selection of risk factors

Detailed descriptions of the risk selected factors and risk constellation for HAPI development have been described elsewhere [21]. In short, we systematically searched PubMed and MEDLINE for articles that reported significant risk factors and risk scales for HAPI and PI development until November 2019. We identified 35 relevant publications [21] and seven risk scales, i.e., SCIPUS, SCIPUS-A, Braden, Norton, Waterlow, Gosnell, and Abruzzese [16]. After excluding factors due to missing standardized documentation and adding six items based on our clinical experience (gastroenteritis, sleep apnea syndrome, hypoxemia, abnormal leukocyte count, urinary management system, and muscle relaxants), we identified 85 risk factors.

For this study, we focused on the 15 previously identified risk factors by Najmanova et al. that were significantly different between patients who developed and who did not develop a HAPI during their first rehabilitation. Five risk factors (length of stay (LOS) in SCI/D center, ASIA A classification [26], autonomic dysreflexia, pneumonia, and sedative medication) and four scoring tools (Braden Scale, SCIPUS scale, SCIM, FIM). Further six risk factors (hypertensive episode, abnormal body temperature, one or more surgeries, albumin level, vitamin D level, and hemoglobin) tended to differ between groups and were considered clinically relevant for the development of HAPI.

Data collection

Data were extracted from the hospital medical information systems and variables were subdivided as sociodemographic characteristics, non-modifiable, and modifiable risk factors. In general, sociodemographic characteristic, non-modifiable factors, and among modifiable factors all risk scales and scoring systems as well as all quantifiable variables were assessed on admission. Acute comorbidities were grouped as modifiable factors and assessed whenever they occurred, as well as retrospectively analyzed within three days before each HAPI occurrence. For optimal data quality, investigators CN and KN discussed the unclear cases and used the same terms of reference and standard procedures for data collection.

Statistical analysis

Baseline variables of continuous data are shown as median with interquartile range (IQR) or mean ± standard deviation (SD) according to normal distribution. Categorical variables are shown as number (n) with percentage (%), respectively.

The primary endpoint was comparing the above mentioned 15 previously identified risk factors for HAPI development [21], according to time since SCI/D (< 1 year, 1–15 years and > 15 years) and patients’ age (18–35 years, 35–65 years, > 65 years). The choice of these cut-offs is based on the knowledge that the risk for HAPI development is high during the first year of SCI/D and increases significantly after 15 years following SCI/D [10]. Age categories was chosen per previous studies [21]. Group comparison of continues data are shown as mean ± SD and compared using an analysis of variance (ANOVA). Group comparison of categorical data are shown as numbers (n) with percentage (%) and compared using a X² test. Tests were corrected for multiple testing according to Bonferroni method and a p-value < 0.003 was considered statistically significant considering the 15 comparison tests performed per category (time since SCI/D and patient’s age). Between group difference were assessed for statistically significant variables using a posthoc X² test or t-test, respectively, and adjusted for Bonferroni method.

Secondary endpoints were comparisons of all 85 variables for the groups time since SCI/D and patients’ age. Group comparison of continues data are shown as mean (SD) and compared using an ANOVA. Group comparison of categorical data are shown as numbers (n) with percentage (%) and compared using a X² test. As these analyses are hypothesis generating without a priori hypothesis, no multiple testing was performed.

Data were analyzed using R statistical software [27]. A two-sided P-value of < 0.05 was considered to be statistically significant unless stated otherwise.

We identified 96 patients, mean age 58.67 +/-15.5 years and 71 (74%) patients were male (Table 1). 53 (55%) patients had a PI on admission. All 96 patients developed at least one HAPI, 45 (47%) patients developed two HAPI, 23 (24%) patients developed three HAPI, ten (10%) patients developed four HAPI, six (6%) patients developed five HAPI, and two (2%) patients developed six HAPI during the observation period. In total, 182 HAPI were recorded (Fig. 1).

Table 1

Comparison of 15 previous identified risk factors for HAPI development between different subgroups time since SCI/D
	< 1 year	1–15 years	> 15 years	p-value
Number of participants	49	9	38
SCI characteristics
AIS A classification	25 (51)	9 (100)	29 (76)	0.004
Autonomic dysreflexia	34 (69)	1 (11)	6 (16)	<0.001*^#
Variable factors during hospitalization
Abnormal temperature	39 (80)	4 (44)	16 (42)	0.001*^#
Abnormal temperature severity				<0.001
<35°C	5 (10)	2 (22)	10 (26)
35.0°C − 37.5°C	0 (0)	0 (0)	1 (3)
37.6°C − 38.4°C	15 (31)	0 (0)	3 (8)
≥38.5°C	19 (39)	2 (22)	2 (5)
Unknown	10 (20)	5 (56)	22 (58)
Hypertensive episode	28 (57)	1 (11)	8 (21)	0.001^#
Sedative medications	41 (84)	3 (33)	10 (26)	<0.001*^#
Pneumonia	24 (49)	1 (11)	2 (5)	<0.001*^#
One or more surgeries	19 (39)	8 (89)	30 (79)	<0.001*^#
Laboratory values
Hemoglobin (g/L)	94.2 (17.7)	130.0 (19.9)	120.6 (25.6)	<0.001*^#
Albumin (g/L)	29.5 (4.4)	37.3 (6.2)	33.7 (6.1)	<0.001*^#
Vitamin D (nmol/L)	42.3 (24.2)	74.2 (16.9)	61.8 (30.7)	0.003*^#
Other factors
Braden scale				<0.001
15–18	2 (4)	4 (44)	15 (39)
13–14	12 (24)	4 (44)	21 (55)
10–12	35 (71)	1 (11)	2 (5)
SCIPUS scale				0.006
3–5	0 (0)	0 (0)	1 (3)
6–8	1 (2)	4 (44)	8 (21)
9–25	48 (98)	5 (56)	28 (74)
Unknown	0 (0)	0 (0)	1 (3)
SCIM	14.2 (11.6)	27.6 (20.1)	35.4 (17.9)	<0.001*
FIMc	24.3 (10.0)	33.9 (2.4)	33.5 (5.8)	<0.001*^#
LOS in SCI center				<0.001
<3 months	2 (4)	7 (78)	21 (55)
3–6 months	13 (27)	2 (22)	15 (39)
>6 months	34 (69)	0 (0)	2 (5)
A p < 0.0033 is considered statistically significant adjusted for multiple testing according to Bonferroni. A p < 0.05 is considered statistically significant for the posthoc test according to Bonferroni.
* Significant difference between ≤ 1 year and ≥ 15 year
# Significant difference between ≤ 1 year and 1–15 year
Parameters were collected at hospital admission

Subgroup time since SCI/D

Comparing the subgroups time since SCI/D, there was a significant difference in autonomic dysreflexia (p < 0.001), with a significantly higher rate in patients with SCI/D < 1 year compared to SCI/D 1–15 years (p = 0.01) and > 15 years (p < 0.001) (Table 1). Abnormal body temperature differed significantly during hospital stay (p = 0.001), with a higher rate in patients with SCI/D < 1 year compared to patients with SCI/D 1–15 years (p = 0.002). Patients with SCI/D < 1 year experienced more often hypertensive episodes during hospital stay compared to patients with SCI/D 1–15 years (p = 0.005), took significant more often sedative medication compared to patients with SCI/D 1–15 years (p = 0.014) and > 15 years (p < 0.001) and suffered more often from pneumonia during their hospital stay compared to both other subgroups (p < 0.001). One or more surgeries occurred more often in patients with SCI/D 1–15 years compared to < 1 year (p = 0.048) and in patients with SCI/D > 15 years compared to < 1 year (p = 0.001). In patients with SCI/D < 1 year, mean hemoglobin (p < 0.001; p < 0.001), albumin (p = 0.002; p = 0.006) and vitamin D levels (p = 0.035; p = 0.013) were significantly lower compared to SCI/D 1–15 years and > 15 years. Patients with time since SCI/D < 1 year had lower points (10–12) on the Braden Scale (p < 0.001) which refers to a higher PI risk. These patients also had significantly lower mean points on the SCIM (p < 0.001) compared to subgroups SCI/D 1–15 years and significantly lower mean points in FIMc score (p = 0.0045; p < 0.001) compared to the other subgroups time since SCI/D, in line with less independence in activities of daily living. Patients with SCI/D < 1 year had the longest length of hospital stay in SCI center with 69% staying > 6 months compared to the other two subgroups (p < 0.001).

Additional most notable risk factors were statistically significant in the subgroup time since SCI/D. Compared to both other times since SCI/D groups, patients with time since SCI/D < 1 year stayed significantly more often at intensive care unit (ICU) (p < 0.001) (supplementary materials – Table 1), had significantly more often hypoxemia (p < 0.001) (supplementary materials – Table 3), and had significantly more often fecal incontinence (p < 0.001) (supplementary materials – Table 2). Patients with SCI/D < 1 year had significantly more often higher points (20–45) in the Waterlow score indicating a very high PI risk (p < 0.001) (supplementary materials – Table 6), compared to patients with SCI/D 1–15 years.

Table 2

Comparison of 15 previous identified risk factors for HAPI development between different subgroups age
	18–35 years	35–65 years	> 65 years	p-value
Number of participants	10	51	35
SCI characteristics
AIS A classification	7 (70)	32 (63)	24 (69)	0.816
Autonomic dysreflexia	6 (60)	19 (37)	16 (46)	0.373
Variable factors during hospitalization
Abnormal temperature	7 (70)	31 (61)	21 (60)	0.840
Abnormal temperature severity				0.945
<35°C	1 (10)	9 (18)	7 (20)
35.0°C − 37.5°C	0 (0)	1 (2)	0 (0)
37.6°C − 38.4°C	2 (20)	10 (20)	6 (17)
≥38.5°C	4 (40)	11 (22)	8 (23)
Unknown	3 (30)	20 (39)	14 (40)
Hypertensive episode	4 (40)	19 (37)	14 (40)	0.963
Sedative medications	7 (70)	28 (55)	19 (54)	0.650
Pneumonia	1 (10)	14 (27)	12 (34)	0.318
One or more surgeries	4 (40)	31 (61)	22 (63)	0.412
Laboratory values
Hemoglobin (g/L)	116.0 (20.0)	109.1 (28.5)	104.1 (22.1)	0.389
Albumin (g/L)	30.3 (5.5)	32.1 (6.0)	30.7 (5.3)	0.520
Vitamin D (nmol/L)	37.2 (13.7)	51.0 (24.9)	54.1 (34.2)	0.329
Other factors
Braden scale				0.853
15–18	2 (20)	10 (20)	9 (26)
13–14	3 (30)	22 (43)	12 (34)
10–12	5 (50)	19 (37)	14 (40)
SCIPUS scale				0.002
3–5	1 (10)	0 (0)	0 (0)
6–8	1 (10)	10 (20)	2 (6)
9–25	7 (70)	41 (80)	33 (94)
Unknown	1 (10)	0 (0)	0 (0)
SCIM	20.7 (18.3)	25.9 (18.8)	21.7 (17.2)	0.489
FIMc	28.4 (10.1)	29.2 (9.0)	28.4 (9.5)	0.917
LOS in SCI center				0.450
<3 months	4 (40)	13 (25)	13 (37)
3–6 months	1 (10)	18 (35)	11 (31)
>6 months	5 (50)	20 (39)	11 (31)
A p < 0.0033 is considered statistically significant adjusted for multiple testing according to Bonferroni. A p < 0.05 is considered statistically significant for the posthoc test according to Bonferroni.
* Significant difference between ≤ 1 year and ≥ 15 year
# Significant difference between ≤ 1 year and 1–15 year

Table 3

Comparison of all significant risk factors for HAPI development between subgroups time since SCI/D and patients age
	Time Since SCI/D			Patients’ age
	< 1 vs 1–15 years	< 1 vs > 15 years	1–15 vs > 15 years	18–35 vs 35–65 years	18–35 vs > 65 years	35–65 vs > 65 years
SCI characteristics
AIS A classification	ns	ns	ns	ns	ns	ns
Autonomic dysreflexia	0.011	< 0.001	ns	ns	ns	ns
Variable factors during hospitalization
Abnormal temperature	0.002	ns	ns	ns	ns	ns
Hypertensive episode	0.005	ns	ns	ns	ns	ns
Sedative medications	0.014	< 0.001	ns	ns	ns	ns
Pneumonia	< 0.001	ns	ns	ns	ns	ns
One or more surgeries	0.048	0.001	ns	ns	ns	ns
Laboratory values				ns	ns	ns
Hemoglobin (g/L)	< 0.001	< 0.001	ns	ns	ns	ns
Albumin (g/L)	0.002	0.006	ns	ns	ns	ns
Vitamin D (nmol/L)	0.035	0.013	ns	ns	ns	ns
Other factors				ns	ns	ns
SCIM	0.053	0.001	ns	ns	ns	ns
FIMc	0.0045	< 0.001	ns	ns	ns	ns
A posthoc p-value corrected for Bonferroni with a significance level at p < 0.05 was computed for all comparisons in case there was a statistically significant difference in the overall group comparison as indicated in Table 1 and Table 2.

Patients with SCI/D 1–15 years and > 15 years had more often PI in patients history (p < 0.001) (supplementary materials – Table 1).

Subgroup age

Comparing the 15 previously discribed risk factors in the subgroups age, we only found a significant difference on the SCIPUS scale, were more patients > 65 years had a higher SCIPUS score, indicating a higher risk for PI development compared to the other two age groups (p = 0.002) (Table 2).

Additional risk factors were statistically significant in the subgroup age: patients > 65 years were significantly more often diagnosed with arterial hypertension (p < 0.001) (supplementary materials – Table 8), and had a lower eGFR (p < 0.001) (supplementary materials – Table 11).

A complete list of all HAPI risk factors can be found in supplementary material Table 1–6 and Table 8–13.

HAPI characteristics

Patients with SCI/D < 1 year, had up to 6 HAPI. HAPI stage I occurred most frequently (n = 55, 79%), and the most common localization was the foot (Supplementary materials – Table 7). In the subgroup time since SCI/D 1–15 years only up to 3 HAPI per patient occurred, most common at stage II localized over coccyx/sacrum. In patients with SCI/D > 15 years, up to 6 HAPI per patient were documented, most frequently as stage II localized most frequent over coccyx/sacrum.

In subgroup age 18–35 years patient had no more than 3 HAPI during hospitalization. Most common was stage I (Supplementary materials – Table 14), localized at the foot. In age group 35–65 years, up to 5 HAPI occurred per patient, most common was stage II and preferred localization in this subgroup was coccyx/sacrum. In the age group > 65 years, up to 6 HAPI per patient occurred most common as stage II localized at the coccyx/sacrum.

Median time until occurrence of first HAPI was between 22 and 33 days and did not significantly differ between subgroups (Supplementary materials – Tables 7 and 14).

Table 3 gives an overview about the significant risk factors in the subgroup time since injury and patients’ age: SCI characteristics, HAPI characteristics, variable factors during hospitalization, patient characteristics, laboratory values, PI characteristics and others.

The main finding of this study is that previously identified risk factors for HAPI development differ in subgroups time since SCI/D while they remain comparable in subgroups patients’ age. Comparing patients with SCI/D < 1 year with the other time since SCI/D subgroups, autonomic dysreflexia, abnormal body temperature, hypertensive episode, and pneumonia occurred more often. Furthermore, in this group mean hemoglobin, albumin and vitamin D levels were significantly lower compared to the other subgroups. Patients with time since SCI/D < 1 year had lower points (10–12) in Braden Scale. Comparing patients’ age groups, only the SCIPUS score was higher in patients > 65 years compared to the other two age groups.

We found that the years since SCI/D influence the risk constellation for HAPI development with most of the previously identified risk factors by Najmanova et al. [21] differing in the subgroups, showing that patients with a shorter time since SCI/D have different risk constellation for HAPI development than patients with a longer time since SCI/D. Whereas the first year after SCI/D is challenging due to several adaptation processes, the following years are often more stable concerning specific complications such as PI or respiratory failures [1, 33]. The risk for developing PI in general after SCI/D increases again following a stabilization phase [10]. The early phase after a new SCI/D is characterized by different but relevant adaptation processes [28]: First, changes in the senso-motor function caused by the SCI/D leads to an altered perception of body and thus the ability to change position [29, 30]. Second, changes in the autonomic nervous system leads to an increased risk of hypotension and bradycardia [31, 32]. Third, changes in the immunological response leads to an increased risk for infection [33]. Combining these concurrent risk factors could explain the increased risk of HAPI in the early time following an SCI/D as well as the different risk factor constellation leading to HAPI development.

Autonomic dysregulation often occurs during the first weeks and harmonizes during the next years, thus explaining why we observed a significant difference early after SCI/D [31]. Lower albumin and vitamin D levels in this group could be caused by acuteness of disease [35] and increased levels afterwards may be related to oral substitution in patients with longer disease duration. Lower hemoglobin levels in patients with SCI/D < 1 year could be due to acute illness and recent stay in the ICU. The fact that this patient group stayed more often in the ICU could also explain why in the same patient group sedative medication was used more often. These results underline that patients with a newly acquired SCI/D are at risk for developing HAPI regardless of the completeness of the injury. Whether forced treatment of anemia, vitamin D deficiency, malnutrition and infection can lower this risk of HAPI development remains uncertain and must be discussed taking other guidelines and recommendations into consideration (e.g., treatment of anemia in acute care).

Lower SCIM and FIMc scores are observed in patients with HAPI and SCI/D < 1 year compared to patients more than one year after SCI/D. Lower SCIM and FIMc scores might be an indicator for more severe SCI/D and therefore more adaptation processes and more impaired senso-motor and autonomic nervous system is present leading to an increased risk during the initial phase. When patients have adapted to life with their SCI/D also patients with higher dependency and lower SCIM or FIMc scores might have successfully integrated HAPI prevention strategies together with relatives and nurses and thus experience a lower rate of HAPI [36].

When discussing the few differences in-between the patients’ age groups, only the usually known changing comorbidities appeared. This underlines that the dynamic of the adaptation process to the newly acquired SCI/D and the years lived with a SCI/D has a stronger influence on the PI risk constellation than actual ageing.

Identifying risk factor constellation at different time frames after SCI/D and per patients’ age is a first measure in preventing HAPI development and could be used to improve clinical routine through educating health care professionals and patients. In patients with an SCI/D, different risk factors seem to be underlying HAPI development. An awareness of these different risk constellations in the time since SCI/D might lead to different prevention strategies. The detected significant risk factors can be integrated into the development of a data-driven risk calculation. Our study shows that there are significantly more differences when analyzing SCI/D patients by means of time since injury than by patients’ age. We found that in the subgroup with less time since SCI/D the occurrence of risk factors for HAPI development was more frequent, which could lead to building clusters of risk factors that might influence each other and lead to a higher risk of HAPI development in this patient group. These results show the need for future directives to use clinically available data to develop a multi-modal machine learning predictive risk model of HAPI development, based on ongoing monitoring of baseline characteristics and modifiable risk factors with a long-term goal of integrating the knowledge about risk factor constellations for HAPI in prevention measures in patients with SCI/D.

Some limitations should be considered: first, although the observation of our cohort including documentation of HAPI was done prospectively, the risk factors were additionally extracted from medical records retrospectively. Therefore, some factors might be missing in the continuous documentation which could influence the frequency of documented risk factors. Second, as the documentation of HAPI was part of a quality assurance project based on additional documentation of HAPI, not all patients with HAPI might be documented. However clinical investigators searched medical records of reported patients for further so far not documented HAPI and thus minimized missing HAPI recording. Third, autonomic nervous system functioning was not documented consequently with a standardized assessment. The detection of autonomic dysfunction was based on routinely measured blood pressure, heartrate, and documentation in the diagnoses. Therefore, autonomic dysfunction might be insufficiently documented in patients with SCI/D > 1 year. Fourth, the subgroup time since SCI/D 1–15 years was rather small with only nine patients. Whether during this period patients develop HAPI less often is unclear and extrapolation to the general should be done with caution.

Until today, no predictive model for HAPI development in SCI/D patients has been developed; however, our findings prove the association between time since SCI/D and risk factor frequency. The knowledge about this correlation could improve the clinical management and prevention measures of HAPI in SCI/D patients and in general avoid complications. The management of preventing HAPI should take different risk constellations like time since SCI/D into account, to establish an individual, databased prevention strategy.

Author Contributions: Charlotte Neuhauser: study design, data collection, data interpretation, manuscript preparation and revision. Clara O. Sailer: study design, data analysis and interpretation, manuscript preparation and revision. Klara Najmanova: study design, data collection, manuscript revision. Michael Baumberger, Dirk Johannes Schaefer, Reto Wettstein: study design, manuscript revision. Diego Paez-Granados: data analysis and interpretation, manuscript revision. Anke Scheel-Sailer: study design, data collection, data interpretation, manuscript preparation and revision.

Funding: This research received no external funding

Institutional Review Board Statement: This study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Ethics Committees of Northwest and Central Switzerland on (protocol code EKNZ ID 2019-02179, date of approval 25th November 2019).

Informed Consent Statement: Informed consent was obtained from all subjects involved in the study.

Data Availability Statement: All data are stored by the corresponding author and can be requested individually from the corresponding author.

Acknowledgments: We thank the “Decu Care Team” (Jessica Decker, Eva Kissling, Rita Müller, Diana Sigrist-Nix, Ivonne Zamzow) for assistance with data collection and Karin Gläsche as the main supervising and responsible nurse. A special recognition goes to Stefanie Tesini for the composition of the database.

Conflicts of Interest: The authors declare no conflict of interest.

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Risk Constellation Of Hospital Acquired Pressure Injuries In Patients With A Spinal Cord Injury/ Disorder - Focus On Time Since Spinal Cord Injury/ Disorder And Patients’ Age

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Abstract

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Introduction

Materials And Methods

Study design and setting

Cohort and observation period

Selection of risk factors

Data collection

Statistical analysis

Results

Subgroup time since SCI/D

Subgroup age

HAPI characteristics

Discussion

Limitations

Conclusions

Declarations

References

Additional Declarations

Supplementary Files

Status:

Journal Publication

Version 1