Abstract
To compare the predictive ability and reliability of two pressure injury (PI) assessment tools, the Neonatal/Infant(N/I) Braden Q and Braden QD scale, in neonates. A prospective and cross‐sectional study. This study was conducted in the neonatal intensive care unit (NICU) of a tertiary‐level university hospital in China between April and June 2023. A total of 410 patients were included in this study. Risk assessment was performed with the N/I Braden Q scale, followed immediately with the Braden QD scale once daily. Risk assessment was terminated when the PI developed or the patient was discharged from the NICU or died. Each patient's final risk assessment was considered in the data analysis. The area under the curve (AUC) of the two scales was 0.879 and 0.857, respectively. The sensitivity, specificity, positive predictive value, negative predictive value and Cronbach's α coefficient of the N/I Braden Q Scale scores were 0.844, 0.833, 0.30, 0.984 and 0.806, respectively. The Braden QD scale scores were 0.938, 0.733, 0.229, 0.993 and 0.727, respectively. Both scales are valid and reliable in predicting the risk of PI in the NICU. The N/I Braden Q Scale was better to distinguish patients at PI risk and not at PI risk than the Braden QD scale. The literature is limited on this topic. This study provides insight into the comparison of different pressure injury risk assessment scales. The findings of this study may guide nurses to choose a suitable tool to assess the risk of pressure injury in neonates.
Keywords: infant, newborn, predictive value of tests, pressure ulcer
1. INTRODUCTION
Pressure ulcers were redefined as pressure injuries (PIs) in 2016; PIs are limited injuries underlying tissue or to the skin when pressure or a combination of pressure and shear is present. 1 PIs are recognised as a causation of iatrogenic harm and pains, which incurs high treatment costs. 2 The estimated average cost for the treatment of Stage 3 and 4 PIs is as high as $20 000 in paediatric inpatients, and PIs are associated with longer length of stay in very young patients. 3 The National Pressure Ulcer Advisory Panel originally drew attention to PIs since a monograph described their high incidence and prevalence in 2001. 4 Newborns and infants under 2 years of age are vulnerable populations because of immature integumentary systems. 2 The epidermal layer in neonates is thinner than that in toddlers and older children, placing them at high risk for excessive water loss and higher permeability to chemicals. 5 A review of PIs in a paediatric inpatient population revealed that the prevalence of PIs varies between 2% and 28%. 6 However, the incidence of PIs is significantly higher in children with specific disease diagnoses, such as spina bifida, estimated at 20%–43%. 7
Many factors contribute to skin breakdown in the paediatric inpatient population. Marufu et al. observed that medical devices are associated with an increased risk of developing PIs in neonates. 8 Clinical devices are suggested as the chief cause of PIs in neonates and children, accounting for 38.5%–90% of PIs. 9 , 10 In addition, gestational age (GA) at birth and the length of stay have a direct impact on PIs. 11 , 12 Other factors including infection, malnutrition, anaemia, immobility and medication (e.g., use of sedatives and vasopressors) are also the main reasons for the high incidence and prevalence of PIs. 7 Therefore, the use of a reliable and valid assessment tool including these factors to identify PI development risk is essential. Knowing the subscale scores and total risk can help nurses adopt suitable measures to mitigate the identified risk. 13
Currently, there are nearly 10 published paediatric PI risk assessment scales. 7 The Braden Q scale is a generally used tool in paediatric patients. 14 However, the Braden Q scale fails to predict the damage caused by clinical devices. Curley et al. 15 described the development and preliminary testing of the Braden QD scale in 2018. They concluded that the Braden QD scale is highly reliable in predicting immobility‐related PIs and medical device‐related PIs in paediatric acute care units. Wu et al. 16 tested the Chinese version of the Braden QD scale, and proved that the Chinese Braden QD scale has good validity and reliability. However, existing literature provides evidence that the Braden QD scale failed to assess full risk factors that may cause PIs in neonates. The Neonatal/Infant Braden Q scale (N/I Braden Q scale) is a combination of the neonatal skin risk assessment scale and the Braden Q scale. This scale includes general risk and neonate‐specific risk, such as general physical condition and the need for oxygenation. 17 , 18 Wu et al. 19 concluded that the Chinese version of the N/I Braden Q scale has an early predictive effect on the occurrence of PIs in neonates, but the evidence supporting the use of the N/I Braden Q scale is still limited in China. These results indicate that further research is needed to determine the predictive validity and reliability of the two scales in the NICU. This study examined the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and reliability of the following two risk assessment scales: the Braden QD, and N/I Braden Q scales. In addition, the effect of diverse risk factors on the total scores of both scales was also investigated in the present study.
2. METHODS
2.1. Design
This was a prospective, cross‐sectional study.
2.2. Study setting
Paediatric inpatients at one neonatal intensive care unit (NICU).
2.3. Sampling and participants
This study included 410 neonates who were admitted to the NICU at the West China Second University Hospital, Chengdu City, Western China. Eligible patients were preterm to 28 days of age, on bed rest for at least 24 h from hospital admission, and with at least one medical device attached. We excluded patients with genetic dermatological diseases, fractures or lacerations that caused skin breakdown on admission.
2.3.1. Sample size
The sample size was calculated in Medcalc. Type I and II errors were 0.05 and 0.20, respectively. According to the previous study, the area under the ROC curve and null hypothesis value were 0.875 and 0.815, respectively. The ratio of sample sizes in negative/positive groups was 1. Considering a 10% loss of follow‐up rate, the minimum sample size was 400. In this study, we included 410 participants.
2.4. Instruments
2.4.1. The Chinese version of the Braden QD scale
The Chinese version of the Braden QD scale 16 was developed in 2021 and has performed well in predicting immobility‐related PIs and medical device‐related PIs. The Chinese version of the Braden QD scale includes three dimensions in seven subscales: assessing the intensity and duration of pressure, tolerance of the supporting structures and skin, and the presence of medical devices. All subscales are rated from 0 to 2: the total score ranges from 0 to 20, and a higher score indicates a higher occurrence of PIs. The subscale item ‘number of medical devices’ assigns 1 point per device, up to a maximum of eight devices. The intra‐class correlation coefficient (ICC) for the Chinese version of the Braden QD scale was 0.991. 16 This scale is applied to preterm to 21‐year‐old patients.
2.4.2. The Chinese version of the N/I Braden Q scale
The Chinese version of the N/I Braden Q scale 19 was introduced in 2019. This scale consists of eight subscales across two dimensions, which assess the intensity and duration of pressure, skin tolerance and the supporting structures. All subscales are rated from 1 to 4, and the total score ranges from 8 to 32, with a lower score indicating a higher risk of PIs. The ICC of the Chinese version of the N/I Braden Q scale is 0.908. 19
2.5. Data collection
The PI risk was described using the Chinese versions of both, the Braden QD and N/I Braden Q scales once a day, and both scales were conducted for about 15 min. The order of assessment was the Braden QD scale first, and the N/I Braden Q scale followed immediately. The PI risk assessment of enrolled participants was evaluated by one (the same) researcher during the study. The researcher worked in the NICU as a nurse and was trained in the use of both scales. Subject data were considered complete on the occurrence of PIs at the hospital, and discharge or death. The development of PIs was determined according to the 2016 National Pressure Ulcer Advisory Panel PI Staging System.
2.6. Data analysis
SPSS 23.0 and Medcalc 15.11 were used to analyse the data. Social demographic clinical characteristics of patients and the incidence of PI were summarised using descriptive statistics. Frequencies (percentages) were used for categorical variables. The mean (SD) was used when the quantitative variable was normally distributed, and the medians (interquartile range [IQR]) were used when the quantitative variables were not normally distributed. According to the Youden Index, the sensitivity, specificity, PPV and NPV were calculated as the predictive validity of scales. The ROC curve was generated and the AUC was reported. The internal consistency reliability of the scales was evaluated by Cronbach's alpha coefficient, as well as the Spearman correlation coefficient between the items of the scale and total scores. The multiple linear regression analysis and a stepwise model were evaluated to assess the risk factors affecting the Braden QD scale. The N/I Braden Q scale was excluded from the regression analysis because the risk factors included in the regression analysis were also items of the scale. A value of p < 0.05 was considered statistically significant.
2.7. Ethical consideration
The study was approved by the Medical Ethics Committee of West China Second University Hospital. The parents of the patients provided written permission for their children's participation in the study.
3. RESULTS
3.1. Demographic and clinical characteristics of NICU patients
This study included 410 infants (208 male and 202 female). The mean GA was 36.8 ± 3.2 weeks. The mean birth weight was 2759 ± 768 g. The median age at the admission was 2 (0–6) days. Thirty‐two infants developed PIs, including 30 (93.7%) preterm infants and two (6.3%) term infants. The PI incidence was 7.8%. The nasal septum was the most frequent location (90.6%). All PIs were grade 1 (Table 1).
TABLE 1.
Sample details.
Item | Category | n (%)or Mean ± SD | Median (interquartile range [IQR]) |
---|---|---|---|
Sex | Male | 208 (50.7) | |
Female | 202 (49.3) | ||
GA at birth (w) | 36.8 ± 3.2 | ||
Birth weight (g) | 2759 ± 768 | ||
Age (d) | 2 (0–6) | ||
Admitting diagnosis | Respiratory system disease | 98 (23.9) | |
Cardiovascular system disease | 11 (2.7) | ||
Digestive system disease | 172 (40) | ||
Other problems | 129 (31.5) | ||
Length of NICU stay | 7 (4–17) | ||
Laboratory values | Haemoglobin (g/L) | 159 ± 31 | |
Leucocyte (×109/L) | 10.7 (8.9–12.7) | ||
Total protein (g/L) (n = 190) | 50.5 ± 6.2 | ||
Medications | Sedatives a | 10 (2.4) | |
Vasopressors b | 5 (1.2) | ||
Oedema | Yes | 8 (2) | |
No | 402 (98) | ||
TPN c | Yes | 32 (7.8) | |
No | 378 (92.2) | ||
Location of PIs | Nasal septum | 29 (90.6) | |
Face | 2 (6.3) | ||
Heel | 1 (3.1) |
Fentanyl, midazolam.
Epinephrine, dobutamine, dopamine, norepinephrine.
Total parenteral nutrition.
3.2. Reliability analyses of the two scales
The Cronbach's α coefficient of the N/I Braden Q and Braden QD scale was 0.806 and 0.727, respectively. A weak, positive and statistically significant correlation was found between the item ‘Friction‐shear’ and the total score of the N/I Braden Q scale (r = 0.151). A strong, positive and statistically significant correlation was found between the N/I Braden Q scale items ‘Nutrition’ (r = 0.838) and ‘Sensory perception’ (r = 0.770) and the total score of the scale. The Braden QD scale item ‘Friction and shear’ (r = 0.167) had a positive, weak and statistically significant correlation with the total score of the scale. The Braden QD scale items ‘Number of medical devices’ (r = 0.908) and ‘Repositionability/skin protection’ (r = 0.732) had a positive, strong and statistically significant correlation with the total score of the scale (Table 2).
TABLE 2.
Scale items and total score correlations.
Scale | Items | r |
---|---|---|
N/I Braden Q scale | 1. Generation's physical condition | 0.726* |
2. Mobility | 0.641* | |
3. Activity | 0.631* | |
4. Sensory perception | 0.770* | |
5. Moisture | 0.205* | |
6. Friction‐shear | 0.151* | |
7. Nutrition | 0.838* | |
8. Tissue perfusion and oxygenation | 0.715* | |
Braden QD scale | 1. Mobility | 0.548* |
2. Sensory perception | 0.713* | |
3. Friction and shear | 0.167* | |
4. Nutrition | 0.631* | |
5. Tissue perfusion and oxygenation | 0.614* | |
6. Number of medical devices | 0.908* | |
7. Repositionability/skin protection | 0.732* |
p < 0.001.
3.3. Predictive validities and ROC analyses of the two scales
The sensitivity and specificity of the N/I Braden Q scale were 0.844 and 0.833, respectively, while the cut‐off value was 24. The sensitivity and specificity of the Braden QD scale were 0.938 and 0.733, respectively, while the cut‐off value was 9 (Table 3). The AUC of the N/I Braden Q scale and the Braden QD scale were 0.879 (95% CI, 0.843–0.909) and 0.857 (95%CI, 0.813–0.902), respectively (Table 3 and Figure 1).
TABLE 3.
The predictive validities of the scales.
Cut‐off point | Sensitivity (%) (95% CI) | Specificity (%) (95% CI) | PPV (%) (95% CI) | NPV (%) (95% CI) | |
---|---|---|---|---|---|
N/I Braden Q score | ≤23 | 56.3 (37.7–73.6) | 87.8 (84.1–91.0) | 28.1 (20.6–37.0) | 96 (94.1–97.2) |
≤24 | 84.4 (67.2–94.7) | 83.3 (79.2–86.9) | 30.0 (24.6–36) | 98.4 (96.6–99.3) | |
≤25 | 87.5 (71.0–96.5) | 75.9 (71.3–80.2) | 23.5 (19.8–27.7) | 98.6 (96.6–99.5) | |
≤26 | 93.8 (79.2–99.2) | 59.8 (54.7–64.8) | 16.5 (14.5–18.7) | 99.1 (96.7–99.8) | |
≤27 | 96.9 (83.8–99.9) | 49.7 (44.6–54.9) | 14.0 (12.7–15.5) | 99.5 (96.5–99.9) | |
≤28 | 100.0 (89.1–100.0) | 30.4 (25.8–35.3) | 10.8 (10.2–11.5) | 100.0 | |
Braden QD score | >7 | 100 (89.1–100) | 52.4 (47.2–57.5) | 15.1 (13.8–16.5) | 100 |
>8 | 93.8 (79.2–99.2) | 64.3 (59.2–69.1) | 18.2 (15.9–20.7) | 99.2 (97.0–99.8) | |
>9 | 93.8 (79.2–99.2) | 73.3 (68.5–77.7) | 22.9 (19.7–26.4) | 99.3 (97.3–99.8) | |
>10 | 81.3 (63.6–92.8) | 79.1 (74.6–83.1) | 24.7 (19.7–26.4) | 98 (97.3–99.8) | |
>11 | 59.4 (40.6–76.3) | 83.9 (79.8–87.4) | 23.7 (17.8–31.1) | 96.1 (94.1–97.4) | |
>12 | 34.4 (186.‐53.2) | 89.4 (85.9–92.3) | 21.6 (13.6–32.5) | 94.2 (92.6–95.4) |
FIGURE 1.
ROC curve of the N/I Braden Q and Braden QD scales.
3.4. Risk factors affecting the total score of the Braden QD scale
The multiple regression analysis between the total score of the Braden QD scale and PI risk factors (GA, birth weight, length of stay, sedatives, vasopressors, oedema, TPN, haemoglobin, leucocyte, total protein) resulted in five steps. In the final model (model 5), the sedatives, TPN, length of stay, vasopressors and GA accounted for 25.7% of the change in the total score of the Braden QD scale (R 2a = 0.257) (Table 4).
TABLE 4.
The effect of PI risk factors on the Braden QD scale’ total score. a
Model | Variables | Unstandardized coefficients | t | p | 95%CI | R | R 2 a | p | ||
---|---|---|---|---|---|---|---|---|---|---|
B | SE | |||||||||
1 | (Constant) b | 8.56 | 0.211 | 40.585 | <0.001 | 8.144 | 8.976 | 0.404 | 0.159 | <0.001 |
Sedatives | 7.84 | 1.297 | 6.046 | <0.001 | 5.282 | 10.398 | ||||
2 | (Constant) b | 8.385 | 0.213 | 39.41 | <0.001 | 7.965 | 8.804 | 0.456 | 0.2 | <0.001 |
Sedatives | 7.024 | 1.29 | 5.445 | <0.001 | 4.479 | 9.569 | ||||
TPN | 2.479 | 0.766 | 3.237 | 0.001 | 0.968 | 3.99 | ||||
5 | (Constant) b | 12.744 | 2.447 | 5.209 | <0.001 | 7.916 | 17.571 | 0.526 | 0.257 | <0.001 |
Sedatives | 5.903 | 1.286 | 4.59 | <0.001 | 3.366 | 8.441 | ||||
TPN | 2.76 | 0.754 | 3.663 | <0.001 | 1.273 | 4.247 | ||||
Length of stay | 0.035 | 0.013 | 2.596 | 0.01 | 0.008 | 0.061 | ||||
Vasopressors | 3.922 | 1.625 | 2.414 | 0.017 | 0.717 | 7.128 | ||||
GA | −0.13 | 0.066 | −1.982 | 0.049 | −0.26 | −0.001 |
Dependent variable: total score of the Braden QD scale.
Constant: the constant value in the multiple linear regression analysis.
4. DISCUSSION
4.1. PIs characteristics
This study included 410 paediatric patients admitted to NICU. Thirty‐two infants had PIs, with a prevalence of 7.8%. All PIs in our study were stage 1 during the hospital stay period. The result was consistent with the international literature, showing prevalence rates between 0.47% and 13% in children. 7 However, previous studies reported a high incidence of neonatal PI up to 16.1% in China, 19 and some PIs in neonates are stage 2, 1 which were different from our results in this study. Partial patients included in the present study needed advanced life support such as non‐invasive/invasive ventilation and all patients needed close medical observation and were attached to medical devices. Therefore, all patients were considered at risk of developing PIs regardless of the risk assessment result, and standard prevention measures were implemented for all of them. Because of the early prevention intervention, the number of patients who developed PIs was small, and only stage 1 PI occurred. Additionally, we found that the majority of PIs developed at a lower gestational age in this study, which may be attributed to the lack of subcutaneous tissue in premature infants. 20 The vast majority of PIs in our study developed in the nasal septal (90.6%). This may be because of the use of non‐invasive ventilation, which can lead to compression ischaemia and consequent development of PI in the nasal area. Additionally, 31 patients developed PIs in the head region. The finding in the present study was in line with a review that reported that the PIs most commonly affected anatomical regions in the head, including the occiput, ears, face and nose, followed by the heels, ankles and elbows. 21
4.2. Reliability of the scales
The reliability of the N/I Braden Q and Braden QD scales was evaluated using the internal consistency (Cronbach's alpha coefficient and scale item‐total score correlations) in this study. A Cronbach's alpha coefficient of 0.70 and above indicates that the scale items are consistent within themselves. 22 In this study, Cronbach's alpha coefficients for both scales were 0.806 and 0.727, respectively. In other words, these two scales are reliable and demonstrate excellent internal consistency. In a previous study, the Cronbach's alpha coefficient of the N/I Braden Q scale was similar to the present result, with a value of 0.871. 23 Other studies reported the reliability of the Braden QD scale ranging from 0.756 to 0.834. 24 The reliability of the Braden scale can be influenced by inter‐rater differences. 25 In this study, the PI risk was evaluated by the same researcher throughout the course of the study, and measurement errors were minimised; thus, we assumed that the Cronbach's alpha coefficient of the Braden QD scale was high.
A higher item‐total score correlation coefficient shows a better correlation between the subscale with other items. Each item should be correlated with the sum scores with a value of 0.30 or above for internal consistency. 22 In this study, the item‐total correlation coefficients were above 0.30, except for ‘moisture’ and ‘friction‐shear’ as items for the N/I Braden Q scale and ‘friction‐shear’ as an item for the Braden QD scale. The reduced impact of moisture on the PIs may be explained by the fact that neonates go through routine changes of linens and diapers in the NICU, which helps reduce the influence of humidity on the development of the PI. The weak correlation between the item ‘moisture’ and the total scale score was also reported by Lima's study. 18 However, the results may be different if the study is implemented in a surgical NICU; the effect of moisture may be stronger because of the drains, ostomy, and other factors that can increase the patients' skin exposure to moisture. Therefore, our results may be limited to NICUs. In this study, bolsters were used on the bedding by nurses as a preventive intervention against PIs, which may help the neonates maintain a relatively good position in the swing and prevent them from slipping and shearing. Besides, most infants were repositioned every 2–3 h. The above measures may weaken the correlation coefficient outcome of the friction‐shear item.
4.3. Predictive validity of the scales
The sensitivity, specificity, PPV and NPV of the N/I Braden Q scale were 0.844, 0.833, 0.30 and 0.984, respectively, whereas those for the Braden QD scale were 0.938, 0.733, 0.229 and 0.993, respectively. Other studies conducted with a neonatal population reported a sensitivity and specificity ranging from 0.75 to 0.83 and 0.742 to 0.81, respectively, of the N/I Braden Q scale. 19 , 26 Previous studies on paediatric patients reported Braden QD scale sensitivity and specificity ranging from 0.86 to 1 and 0.4 to 0.59, respectively. 15 , 24 The results of previous studies and the present study indicated that the sensitivity and specificity of the N/I Braden Q scale were consistently high. Instead, the Braden QD scale's sensitivity and specificity values varied from low to high. Besides, another study showed that the Braden scale's PPV and NPV were 0.15 and 0.98, 27 respectively. The results from the above study, as well as the present study, indicated that the PPV of the Braden scale was consistently low while the NPV maintained high values.
A scale with consistently high values of sensitivity and specificity is thought to have an excellent ability to distinguish between patients at risk and not at risk. Yet, a scale with high sensitivity and low specificity can determine most patients with PIs risk, but the low specificity of the scale can mislead patients without a risk of PIs. The primary objective of PI risk assessment is to identify the patients with risk. In the present study, the N/I Braden Q scale had balanced high values of sensitivity and specificity, while the Braden QD scale sensitivity value was much higher than the specificity value. Through these findings, we can conclude that the predictive ability to distinguish the patients at risk and not at risk was better for the N/I Braden Q scale than for the Braden QD scale.
The PPV represents the probability that a patient with a positive risk assessment scale for a PI actually has a PI. However, the PPV value is affected by patient characteristics, PI rates and inter‐rater differences. 22 PPV was reported at 0.15 in a previous study, which was lower than our study. In previous study, only 17% of patients were <1 month of age, and the PI incidence rate was 8%. 15 In the present study, all patients were <28 days, and PI risk was assessed by the same researcher. Therefore, we obtained a more consistent result with the PPV value.
4.4. Risk factors on the Braden QD scale
As stated previously, many factors can increase the risk of the development of PIs in paediatric patients, including general and individual factors. Therefore, the PI risk assessment should not only be limited to the assessment tool's parameters. In this study, we analysed all patients‐related risk factors except the items of the Braden QD scale. Of all factors, the sedatives, TPN, length of hospital stay, vasopressors and GA affect the sum scores of the scale by 25.7%. A previous study showed that albumin and haemoglobin level, paediatric nutrition risk score, body mass index and length of stay affected Braden scale scores by 30.3% in paediatric patients. 28 Other studies also showed that GA at birth, increasing length of stay, weight loss and oedema were associated with the risk of PI. 12 , 29 These findings showed that other factors related to children can also have an effect on the risk of PIs in addition to the parameters of the scale. Therefore, these other factors should also be taken into account when NICU nurses assess the PIs risk of patients in clinical practice. Besides, nurses should take appropriate measures to decrease the risk.
4.5. Study limitations
Our study limitation deserves comment. Because of the nature of an observational study, exposure and variables cannot be controlled and measurement and sampling errors were potential. Moreover, PI prevention interventions in clinical practice might have influenced the description of the incidence of PIs and the predictive validity estimates such as sensitivity or specificity. Furthermore, the present study was a single‐centre study, leading to limited extrapolation and representativeness of the results.
5. CONCLUSION
PI risk assessment should be a standard care or routine practice used by nurses. Given the findings of this study, both the N/I Braden Q and the Braden QD scale are valid and reliable in identifying the PI risk in NICU patients. However, the N/I Braden Q scale was better for predicting the development of PIs in the neonatal population, according to its sensitivity and specificity. The sedatives, TPN, length of stay, vasopressors and GA were affecting factors on the Braden QD scale. Therefore, nurses should consider these factors when assessing the PIs with the Braden QD scale.
CONFLICT OF INTEREST STATEMENT
The authors have no conflicts of interest to report.
ACKNOWLEDGEMENTS
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors thank Xia Li, Yingxin Li and Zhaolan Zeng for assistance with data collection. In particular, the authors would like to thank Prof. Hu, who provided much support during the research.
Shi Z, Li X. Predictive validity and reliability of two pressure injury risk assessment scales at a neonatal intensive care unit. Int Wound J. 2024;21(2):e14430. doi: 10.1111/iwj.14430
DATA AVAILABILITY STATEMENT
Data available on request due to privacy/ethical restrictions
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Data Availability Statement
Data available on request due to privacy/ethical restrictions