The Ghent Global IAD Monitoring Tool (GLOBIAD‐M) to monitor the healing of incontinence‐associated dermatitis (IAD): Design and reliability study

Karen Van den Bussche; Sofie Verhaeghe; Ann Van Hecke; Dimitri Beeckman

doi:10.1111/iwj.12898

. 2018 May 24;15(4):555–564. doi: 10.1111/iwj.12898

The Ghent Global IAD Monitoring Tool (GLOBIAD‐M) to monitor the healing of incontinence‐associated dermatitis (IAD): Design and reliability study

Karen Van den Bussche ¹, Sofie Verhaeghe ^1,², Ann Van Hecke ^1,³, Dimitri Beeckman ^1,^4,^✉

PMCID: PMC7949751 PMID: 29797507

Abstract

The aim of this study was to design and evaluate the reliability of the Ghent Global incontinence‐associated dermatitis (IAD) Monitoring Tool (GLOBIAD‐M). The tool was designed based on the internationally validated Ghent Global IAD Categorisation Tool (GLOBIAD). After designing and validation by experts, one trained researcher carried out 36 observations of 9 patients affected with IAD. Photographs of the IAD lesions were independently assessed by a second trained researcher. Measures for inter‐rater agreement (p _o ) and reliability [Cohen's Kappa (ĸ) and intra‐class correlation coefficients (ICC)] were analysed. The p _o ranged between 0.86 for the item ‘maceration’ and 0.97 for the item ‘clinical signs of infection’. The ĸ for the item ‘GLOBIAD classification’ was 0.61 [95% confidence interval (CI) 0.28‐0.95] and 0.72 (95% CI 0.50‐0.95) for ‘maceration’. The lowest ĸ was found for the item ‘oedema’ (0.27; 95% CI −0.24‐0.79). The ICC of the item ‘redness’ was 0.83 (95% CI 0.69‐0.91) and 0.87 (95% CI 0.76‐0.93) for ‘skin loss’. The inter‐rater agreement and reliability of the GLOBIAD‐M appears to be good for the assessment of photographs by experts. This tool could support clinical decision‐making for IAD treatment. Further validation with clinicians is, however, needed.

Keywords: assessment, healing, incontinence‐associated dermatitis, instrument, monitoring

1. INTRODUCTION

The prevalence of incontinent individuals across different countries and care settings is high (55‐84%).1 One of the most prevalent skin conditions associated with incontinence is incontinence‐associated dermatitis (IAD).2 IAD is a specific type of irritant contact dermatitis characterised by redness, but in some cases, swelling, vesicles or bullae, skin loss, and/or cutaneous skin infection are present.3 Managing IAD is an important challenge for health care professionals. The application of mild skin cleansers immediately after soiling and protective and caring leave‐on products as part of a structured skin care regimen are recommended for prevention and treatment.4 However, the lack of comparability between studies about efficacy and (cost‐)effectiveness of products and procedures complicates standardisation of IAD management.5 Recognising the condition and distinguishing it from other skin lesions such as superficial pressure ulcers add to the complexity of managing the condition in practice.6, 7, 8, 9

IAD is more common in older patients as the aging process is associated with decreased cell replacement in the skin, compromised barrier function and mechanical protection, and delayed wound healing.10 Despite its acute nature, IAD can become a chronic progressive wound under certain conditions [such as a secondary Candida albicans skin infection11]. Little is known about the time to healing of IAD. Bliss et al12 reported a median time to IAD healing of 11 days (range, 1‐19 days) in critically ill adults in the intensive care unit (ICU). A randomised controlled trial including 142 hospitalised patients reported a completely healed percentage between 9.6% and 21.7% within the study follow‐up period of 6 days.13 Long et al14 reported a median time to healing of 9 days (range, 2‐39 days) in 22 patients with IAD in a long‐term acute care facility setting. International recommendations state that there should be visible improvement of the skin condition and reduction in pain in 2 to 4 days following the implementation of a skin care regimen, with resolution within 2 to 3 weeks.4 Inadequate treatment can cause prolonged discomfort and pain, delayed wound healing, prolonged hospitalisation, and an increase of costs.15, 16

Timely, adequate, and targeted prevention and treatment are essential. Therefore, the use of a valid and reliable instrument to clinically assess IAD based on visual inspection by trained health care professionals is crucial. To date, 5 IAD assessment instruments have been developed and disseminated for the purpose of describing the severity of IAD and its monitoring over time.14, 17, 18, 19, 20 All instruments assess the size of the IAD lesion, either via body locations17, 18, 19, 20 or an estimation of the surface area.17, 18 To monitor the healing over time, 4 instruments use a (cumulative) scoring system.17, 18, 19, 20 Two instruments assess patient‐specific symptoms such as pain and burning.14, 17 Content validity was only assessed in 2 instruments by experts.19, 20 Psychometric properties of 3 instruments were tested by assessing photographs to analyse the inter‐rater reliability, whereas none used multiple photographs of the same IAD lesion.19, 20, 21 Moreover, a feasibility study in 12 incontinent residents in 2 nursing homes concluded that 3 existing IAD assessment instruments were too time‐consuming and (linguistically) too complex for use in routine clinical practice.22 In the observation and monitoring of IAD healing, the use of a valid assessment instrument is important for both clinical practice and clinical research. The recently developed core outcome set (COS) for IAD research, a minimum set of outcomes to be measured and reported in all IAD trials, recommends the assessment of the outcome domains redness, skin loss, maceration, IAD‐related pain, and patient satisfaction.23

To date, there is no internationally, easy‐to‐use, valid, and reliable instrument to monitor the healing of IAD in routine clinical practice and research. In 2017, an important step towards an international language of IAD was the design and international validation of the Ghent Global IAD Categorisation Tool (GLOBIAD).24 The GLOBIAD categorises IAD based on the severity of the skin lesion and distinguishes between the presence of persistent redness [category (cat.) 1] and the presence of skin loss (cat. 2), both subdivided based on the absence (cat. A) and presence (cat. B) of clinical signs of infection.24 Content and face validity of the GLOBIAD were established after a 3‐round Delphi procedure with an international panel of experts from 13 countries. The validation process of the GLOBIAD has been published elsewhere.24 The overall inter‐rater agreement (p ₀) was 0.55 [95% confidence interval (CI) 0.55‐0.56], and the overall inter‐rater reliability [Fleiss kappa (ĸ)] was 0.41 (95% CI 0.41‐0.41) when health professionals apply this tool based on the presented images. Highest inter‐rater agreement values were achieved for differentiating between erythematous skin (cat. 1) and skin loss (cat. 2) [ĸ = 0.65 (95% CI 0.65‐0.65), p ₀ = 0.86].

However, this classification was not developed to monitor the change in IAD status over time. The aim of this study was to design and assess the reliability of a tool to monitor the change in IAD status over time.

2. METHODS

A 2‐phase instrument design and reliability study was conducted.

2.1. Phase 1—Instrument design

2.1.1. Methods

The GLOBIAD and COS were used to design the Ghent Global IAD Monitoring Tool (GLOBIAD‐M) (Figure 1).23, 24 Content and face validity of the GLOBIAD were established after a 3‐round Delphi procedure with an international panel of experts from 13 countries. The validation process of the GLOBIAD has been published elsewhere.24 The GLOBIAD consists of multiple items classified as critical or additional criteria within each of the 4 categories. For the development of the GLOBIAD‐M, the Skin Integrity Research Group (SKINT) at Ghent University (Belgium) extensively reviewed and discussed each item to be included (yes/no) in the GLOBIAD‐M.

The Ghent Global IAD Categorisation Tool (GLOBIAD)

2.1.2. Results

The tool that emerged after expert review is displayed in Figures 2 and 3. The overview of the instrument design is presented in Table 1. The GLOBIAD‐M includes an observation document and a dashboard to allow the monitoring of the healing of IAD.

The Ghent Global IAD Monitoring Tool (GLOBIAD‐M)—daily observation document

The Ghent Global IAD Monitoring Tool (GLOBIAD‐M)—dashboard

Table 1.

GLOBIAD‐M instrument design

GLOBIAD items	Decision	Outcome
Critical criteria
Persistent redness	Inclusion, surface area	Percentage^a ^, ^b
Persistent redness	Inclusion, surface area	Binary (red or green)^b ^, ^c
Skin loss	Inclusion, surface area	Percentage^a ^, ^b
Skin loss	Inclusion, surface area	Binary (red or green)^b ^, ^c
Signs of infection	Summary on dashboard	Binary (red or green)^b ^, ^d
White scaling of the skin	Included identically	Binary (yes or no)^a
Satellite lesions	Included identically	Binary (yes or no)^a
Slough visible in the wound bed (yellow/brown/greyish)	Included as new item “Changes in color in the wound bed (such as green, yellow, brown, greyish)”	Binary (yes or no)^a
Green appearance within the wound bed	Included as new item “Changes in color in the wound bed (such as green, yellow, brown, greyish)”	Binary (yes or no)^a
Excessive exudate levels	Included identically	Binary (yes or no)^a
Purulent exudate levels	Included identically	Binary (yes or no)^a
Shiny appearance of the wound bed	Included as new item “Changes in color in the wound bed (such as green, yellow, brown, greyish)”	Binary (yes or no)^a
Additional criteria
Marked areas or discolouration from a previous (healed) skin defect	Not primarily relevant to IAD healing	/
Shiny appearance of the skin	Incorporated in new item “Changes in color in the wound bed (such as green, yellow, brown, greyish)	Binary (yes or no)^a
Macerated skin	Included identically	Binary (yes or no)^a
Macerated skin	Included identically	Binary (red or green)^b
Intact vesicles and bullae	Not primarily relevant to IAD healing	/
The skin may feel tense or swollen at palpation	Changed to “Oedema is present, skin may feel tense or swollen at palpation”	Binary (yes or no)^a
The skin may feel tense or swollen at palpation		Binary (red or green)^b
Burning, tingling, itching or pain	Incorporated identically	Binary (yes or no)^a
Burning, tingling, itching or pain	Two items were added:	Binary (red or green)^b
	1. ‘Self‐report is not possible’	Binary (yes or no)^b
	1. ‘Self‐report is not possible’	Not reported (N/R)^b
	2. NRS pain scale: to quantify the intensity of IAD‐related pain	Number from 0‐10^a ^, ^b

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Abbreviations: IAD, incontinence‐associated dermatitis; NRS, numerical rating scale.

Displayed on daily observation document.

Displayed on dashboard, red indicates the presence and green the absence.

Red if ≥1% redness or skin loss is present.

Red if ≥1 clinical signs of infection are present.

The observation document (1 page) includes 4 data categories: general data, IAD categorisation (based on the GLOBIAD), observation of IAD and the surrounding skin, and patient's experience. The first category, general data, contains the date, patient identification number, and nurse initials. The second category relates to the categorisation of the IAD according to the GLOBIAD classification system.24 The third category includes 9 items related to IAD and surrounding skin that need to be assessed. The items ‘redness’ and ‘skin loss’ are scored on a grid to automatically calculate the surface area (as a percentage). Next, the presence of ‘oedema’, ‘maceration’, and ‘clinical signs of infections’ (such as satellite lesions) is to be documented. The last category consists of IAD‐related ‘itching’, ‘tingling’, ‘burning’, and ‘pain’. The intensity of the IAD‐related pain is assessed using the Numerical Rating Scale (NRS).25

To monitor the change in IAD status over time, the dashboard comprises a graph and colour‐grading system. Red represents the presence of the item and green the absence.

To illustrate the GLOBIAD‐M, the daily observation document and dashboard of 1 patient is presented in Figure 4.

Example of the GLOBIAD‐M daily observation document and dashboard (patient 4)

2.2. Phase 2—Reliability testing

2.2.1. Setting and participants

The study was conducted in 1 large general hospital in Belgium. All patients meeting the criteria for inclusion were eligible for participation. Inclusion criteria were: (1) being ≥ 18 years, (2) IAD present, (3) expected to have an additional length of stay of a minimum of seven days, and (4) written informed consent by the patient or his/her representative including explicit consent to take photographs of the IAD.

2.2.2. Data collection

The researcher was notified by the clinical nurse specialist in wound care about patients with an IAD diagnosis that potentially could be included (and thus meeting the inclusion criteria). The researcher re‐assessed the eligibility criteria and obtained oral and written consent from the patient or his or her representative. The GLOBIAD‐M was completed on day 1, day 3, day 5, and day 7 through the observation of the patient's skin and the assessment of several symptoms, such as itching and pain. At the same time, a photograph of the IAD lesion was taken with a Canon EOS 60D with lens EFS 17 to 85 mm in the most comfortable position for the patient (lying on the preferred side or standing). To examine the degree of inter‐rater agreement, a second IAD expert independently categorised the IAD lesion (data category 2) and assessed the surrounding skin items (data category 3) for each photograph. If no data from 4 consecutive observation points could be obtained, the data were deleted, and a new patient was included. The aim was a sample of 10 patients with complete data.

2.2.3. Ethical considerations

The study was performed according to the ethical guidelines of the 1975 Declaration of Helsinki and approved by the Ethics Review Committee of Ghent University Hospital and the Ethics Review Committee of AZ Sint‐Lucas Ghent (B670201732140). Written and oral informed consent was obtained from all participating patients or their legal representatives.

2.2.4. Statistical analysis

To examine the degree of inter‐rater agreement, photographs of the IAD lesions were independently assessed by a second IAD expert. The number of patients (n = 9) were based on similar studies ranging from 4 and 9 photo cases.19, 20 However, these studies did not monitor each IAD lesion multiple times. The overall percentage of agreement (p _o) and Cohen's kappa (ĸ) were calculated for ordinal data. The p ₀ is the ratio of exact agreement between the raters to the total number of all ratings. The coefficient ĸ indicates whether observed agreement is higher than or equal to chance agreement. The criteria for the ĸ coefficient by Landis and Koch were used to interpret the results (< 0.00 = Poor, 0.00‐0.2 = Slight, 0.21‐0.40 = Fair, 0.41‐0.60 = Moderate, 0.61‐0.80 = Substantial, and 0.81‐0.99 = Almost perfect).26

Intra‐class correlation coefficient (ICC) was calculated to determine the inter‐rater reliability for the items ‘redness’ and ‘skin loss’. ICC estimates and their 95% confident intervals (CI) were calculated based on single rating [model ICC(2,1)].27 The underlying statistical model is a consistency 2‐way random effects model in which the systematic variability between raters is included. In order to obtain a detailed insight into the actual level of agreement of the calculated inter‐rater reliability coefficients for the variables ‘redness’ and ‘skin loss’, the range of occurred differences between raters was calculated. Additionally, the differences between raters were plotted against their mean score to explicitly show the range and number of disagreements.28 The 95% limits of agreement were calculated as proposed by Bland and Altman.28 All statistical analyses were performed using SPSS statistical package version 24 (SPSS, Inc., Chicago, IL, USA).

3. RESULTS

3.1. General characteristics of the participants

A total of 15 incontinent patients were enrolled in the study of which 6 patients dropped out [due to discharge (n = 2), death (n = 1), and no IAD diagnosed (n = 3)]. Data collection was complete for a total of 9 patients (2 males, median age 78 years) mainly admitted to a geriatric or rehabilitation ward (Table 2). The IAD treatment consisted of the same type of leave‐on product for all patients, a combination of a moisturiser and a skin protectant. None of the IAD lesions healed during study follow‐up period.

Table 2.

Key demographic characteristics of the hospitalised patients

ID	Age (years)	Gender	Mobility^a	Friction and shear^a	Diarrhoea^b	Initial GLOBIAD	Ward type
1	77	F	Very limited	Potential problem	No	2A	Nephrology
2	75	F	Very limited	Potential problem	No	2A	Rehabilitation neurology
3	78	F	Very limited	Actual problem	No	2A	Geriatrics
4	64	M	Slightly limited	No apparent problem	Yes	2A	Rehabilitation chronic
5	89	F	Slightly limited	Potential problem	No	1A	Geriatrics
6	77	F	Very limited	Potential problem	No	2B	Geriatrics
7	85	F	Completely immobile	Potential problem	Yes	2A	Rehabilitation neurology
8	82	F	Very limited	Potential problem	Yes	2A	Geriatrics
9	84	M	Slightly limited	Potential problem	No	2A	Geriatrics

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Abbreviations: F, Female; M, Male; Cat. 1A, persistent redness without clinical signs of infection; Cat. 1B, persistent redness with clinical signs of infection; Cat. 2A, skin loss without clinical signs of infection; Cat. 2B, skin loss with clinical signs of infection.

Braden Risk Assessment subscales ‘Mobility’ and ‘Friction and Shear’.

Present at day 1 or in past 5 days.

3.2. Inter‐rater reliability

The inter‐rater reliability coefficients ĸ, p _o, ICC(2,1) for each assessment item of the GLOBIAD‐M tool are presented in Table 3. All 36 observations were rated, and there were no missing values. The ĸ‐values for items ‘GLOBIAD’ and ‘maceration’ were “substantial” [respectively 0.61 (95% CI 0.28‐0.95) and 0.72 (95% CI 0.50‐0.95)]. For the item ‘clinical signs of infection’, there was no ĸ calculated because the ratings were almost identical (p _o = 0.97). The lowest exact agreement was found for the item ‘maceration’. The lowest inter‐rater reliability coefficient was found for the item ‘oedema’ (0.27, 95% CI −0.24‐0.79), which can be labelled as “fair”.

Table 3.

Inter‐rater agreement and reliability coefficients—2 raters

Items GLOBIAD‐M dashboard	Kappa (95% CI)	p ₀
GLOBIAD	0.61 (0.28‐0.95)	0.89
Oedema	0.27 (−0.24‐0.79)	0.89
Maceration	0.72 (0.50‐0.95)	0.86
Signs of infection	– ^a	0.97
	ICC(2,1) (95% CI)	Range difference ^b
Redness (%)	0.83 (0.69‐0.91)	0‐9%
Skin loss (%)	0.87 (0.76‐0.93)	0‐3%

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Based on the assessment of 36 photographs by 2 raters. 95% CI, 95% confidence interval; p ₀, percentage overall agreement.

Not calculated, almost identical ratings, the variance of this rating is 0.

Difference between rater 1 and rater 2 (range).

High ICC(2,1)‐values were found for the items ‘redness’ and ‘skin loss’, respectively, 0.83 (95% CI 0.69‐0.91) and 0.87 (95% CI 0.76‐0.93). Figure 5 shows the distribution and the amount of rater differences against their average scores for the total sample (n = 36). The size of the circles indicates the frequency of similar values. The 95% limits of agreement correspond to the interval −8.41 to 4.8 for redness and −1.55 to 1.89 for skin loss. Most differences were found within this interval.

Bland‐Altman plots of differences between raters and average scores measured by rater 1 and rater 2

4. DISCUSSION

The aim of this study was to design a tool to monitor the change in IAD status over time (GLOBIAD‐M) and at the same time evaluate the reliability of the GLOBIAD‐M. Content and face validity was established by an international expert panel during the validation of the GLOBIAD tool.24 In this study, the SKINT research group determined the relevance and feasibility of the items, resulting in an instrument with content and face validity.

The GLOBIAD‐M daily observation document includes 4 IAD and surrounding skin assessment items and patient experiences such as itching and pain. Compared with other instruments, Brown and Long et al included the assessment of patient symptoms (tingling, itching, burning, pain), whereas the other instruments did not.18, 19, 20 However, the assessment of IAD‐related patient symptoms such as pain proved to be of critical importance in both the GLOBIAD as the COS for IAD research.23, 24

In this study, the agreement and reliability of the GLOBIAD‐M was examined in a sample of 36 photographs of 9 patients. The estimates indicate a high degree of inter‐rater reliability for the assessment of ‘redness’, ‘skin loss’, ‘maceration’, and ‘clinical signs of infection’. The assessment of ‘oedema’ appeared more difficult. This may be due to the assessment of photographs by the second rater. The GLOBIAD defined oedema as ‘the skin may feel tense or swollen at palpation’, which consequently should be assessed by palpating the skin. Oedema, defined as the presence of ‘swollen/raised areas’, was included in 2 other tools that were not psychometrically tested.14, 17 If further validation points towards the same results, it is recommended to delete this item.

The assessment of the surface area of IAD is in line with other assessment instruments, although different methods are used. The instruments developed by Brown17 and adapted by Long et al14 and Borchert et al19 and Bliss et al20 assesses different skin items for, respectively, 5 (buttocks, coccyx, rectal area, scrotum/perineum, and upper thighs) or 13 body areas. The assessment of large body areas could possibly impede the assessment of the surface area as slight healing will not be noticed. Additionally, Brown includes the size of the lesion by reporting the length and width (in cm) of the left and right side for each of the 5 body areas.17 The instrument of Kennedy & Lutz assesses the estimated area of skin breakdown using a 4‐point scale [no area, small area (≤ 20 cm²), moderate area (20‐50 cm²), and large area (> 50 cm²)].18 This method could pose difficulties as IAD is often characterised by an irregular shape.

In this study, healing was visualised through a dashboard comprising a graph and colour‐grading system. This is in contrast with other IAD monitoring instruments, which use a (cumulative) scoring system17, 18, 19, 20 or no scoring system.14 The use of a scoring system was not preferred as epidemiological data indicating a relation between scores and time to healing is lacking. The GLOBIAD‐M more accurately reflects the items on which the wound improves or deteriorates.

The small sample size is acknowledged as a limitation of this study, which may mean it lacks power; furthermore, follow up over a longer period was not possible, which meant that patients were not monitored after discharge. However, our sample size (36 observations) is comparable with or larger than other similar studies ranging from 4 and 9 photo cases.19, 20 Another limitation is the use of photographs, which provides a 2‐dimensional perspective only. Another consideration is that the surface area of redness and skin loss were estimated by visual observation. Future research could consider the use of an electronic scanning device to assess and monitor IAD.29 In this study, the reliability was assessed by 2 researchers. Further psychometric evaluation with clinicians in clinical practice is recommended with specific attention to the item ‘oedema’.

In this study, time to healing of IAD was not calculated as no complete healing was achieved before discharge. In addition, patients should be monitored over a longer period of time to gain insight into the complete healing of the IAD. In line with our findings, Bliss et al reported that most patients were discharged from the ICU before IAD healed and that hospital‐wide adoption of a defined skin care regimen appears advisable to ensure timely healing of IAD.12 Routine use of an instrument to monitor the magnitude of change in skin damage over time could result in more tailored and adequate treatment. As the psychometric evaluation of the GLOBIAD indicated that reliability was associated with level of education and expertise, training remains an important tool for improving the classification, monitoring, prevention, and treatment of IAD.24, 30

This tool could be used in clinical research as it is largely in line with the recent developed COS for IAD research, which consists of the following critical outcomes for IAD research: ‘erythema’, ‘maceration’, ‘erosion’, and ‘IAD‐related pain’.23 The outcome ‘patient satisfaction’ was not embedded in the GLOBIAD‐M as this is out of scope.

To conclude, the inter‐rater agreement and reliability of the GLOBIAD‐M is high when experts in the assessment of IAD apply this tool based on a set of images. The GLOBIAD‐M could guide clinical decision‐making for treatment of patients with IAD as it can indicate a stagnation or deterioration of the wound healing. Further validation in clinical practice with clinicians is, however, needed.

ACKNOWLEDGEMENTS

The authors thank C. Vandendries, K. Haenebalcke, and all the ward nurses for their contribution to the study.

Conflict of interest

No conflict of interest has been declared by the authors.

Van den Bussche K, Verhaeghe S, Van Hecke A, Beeckman D. The Ghent Global IAD Monitoring Tool (GLOBIAD‐M) to monitor the healing of incontinence‐associated dermatitis (IAD): Design and reliability study. Int Wound J. 2018;15:555–564. 10.1111/iwj.12898

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PERMALINK

The Ghent Global IAD Monitoring Tool (GLOBIAD‐M) to monitor the healing of incontinence‐associated dermatitis (IAD): Design and reliability study

Karen Van den Bussche

Sofie Verhaeghe

Ann Van Hecke

Dimitri Beeckman

Abstract

1. INTRODUCTION