Risk factors of incontinence-associated dermatitis in older adults: a protocol for systematic review and meta-analysis

Introduction

Background

Incontinence-associated dermatitis (IAD)can be characterised as a skin reaction triggered by persistent contact with urine and faecal matter, leading to irritation and potential breakdown of tissue layers, referred to as inflammation and redness in combination with abrasion or ulceration of the upper skin layer.1 Individuals diagnosed with IAD may endure discomfort, stinging, burning, itchy sensations or prickliness in the affected regions.2 In addition to these physical complaints, IAD can also affect individuals’ mental state, social functioning and emotional state, for instance, loss of independence, reduction in social activities, depression, anxiety, anger and isolation.3 Older adults are more susceptible to skin damage due to ageing skin, in addition to cognitive decline in older adults, which can lead to incontinence. Therefore, older people have a higher risk of IAD. Previous studies reveal that the occurrence of IAD among geriatric individuals suffering from incontinence is between 35.4% and 47.7%.4 The reported prevalence of IAD ranges from 4.3% to 42% and reported incidence rates range from 3.4% to 50%.5

The presence of IAD amplifies the possibility of secondary issues like pressure injuries and catheter-related urinary tract infections. Furthermore, treatment and management of IAD typically require extended lengths of hospital stays and higher medical expenses.6 Given the intricate and time-consuming nature of caring for these patients, it poses a daily challenge for healthcare professionals in hospitals and nursing homes and constitutes a pressing international skin health problem.7–9 Therefore, it is important to systematically identify IAD risk factors in older adults.

Many studies have reported the risk factors for IAD in older adults, including the type of incontinence, diabetes, faecal character, diminished cognitive awareness, poor nutritional status and Braden scale scores.5 10–12 However, there are differences in sample sizes between studies, and in medical and economic conditions between study areas. With the recognition that IAD represents a growing concern globally and evidence on risk factors for IAD in older adults is lacking, this research project seeks to establish a systematic review protocol to pinpoint all the determinants of IAD in older adults. We hope that this systematic review serves as a base to fashion effective guidelines to assist practitioners in taking preventative actions against this issue. Based on that, nurses are more likely to pay attention to IAD in patients who have particular risk factors and then give them the proper care early.

Objective

The goal of this systematic review is to identify risk factors associated with IAD in older individuals. This review will be guided by the research question: What are the risk factors for older adults who develop IAD compared with those who do not?

Methods

Study registration

The protocol of our systematic review and meta-analysis is reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols statement guidelines (online supplemental file 1). PROSPERO International Prospective Register of Systematic Reviews is where this systematic review has been registered (CRD42023442585).

Supplemental material

Condition

The main variables of interest will be IAD. Incontinence refers to involuntary leakage of urine or stool due to various underlying aetiological factors.13 Common indicators of IAD typically involve manifestations such as redness (erythema) and skin damage resulting in detachment or sloughing (erosion). IAD often occurs in regions including the perineum, gluteal areas, proximal legs and genitalia.14 15

Types of studies

Cohort studies, case-control studies and cross-sectional studies are the only study designs that are acceptable; case series, clinical guidelines, literature reviews, conference reports and news articles do not. We will accept studies on human subjects from any global region where complete texts are accessible, and all eligible trials fitting our predetermined parameters will receive thorough examination and analysis. Initial screenings shall be from database inception to 18 July 2023, followed by an additional update near completion to account for recent developments before finalising the analysis. Literature retrieval procedures shall remain open-ended during this time frame.

Study population

Older adults with IAD are the primary focus of this systematic review and meta-analysis. According to both the WHO and the United Nations, ‘Older’ is defined as anyone who is 60 years of age or older.16 Alternatively, they may also fall under this category based on definitions outlined in other regions which stipulate age 65 or greater. To increase the number of studies considered, we plan to apply a broader inclusion criteria in the screening process to include participants aged 60 years or older, and the search will be for all ages and results stratified by age.

Exposure

The exposure will include all physiological (general/medical), clinical, social and demographic risk factors related to IAD.

Outcomes

The outcome will concentrate on the risk factors for IAD and will not take into account any other skin injuries, for instance, pressure injuries.

Search strategy

Using the author team’s professional experience, the team has formulated a rigorous search approach encompassing key phrases to maximise precision in identifying applicable content: “incontinence-associated dermatitis / incontinence associated skin damage / diaper rash / perineal dermatitis / moisture lesions” “relevant factor* / influencing factor* / risk factor* / predictor* / related factor* / associated factor* / relative factor* / determinant*”. The search criteria will include human studies from any country and available in full text. The preliminary stage of the search plan to be applied to the PubMed database is shown in online supplemental file 2.

Supplemental material

Initially, searches will be conducted from designated databases followed by a preliminary search on PubMed aimed to evaluate the effectiveness of the search terms, strategies and selection criteria in identifying all applicable articles. Modifications shall be made based on the results obtained. The literature search will contain three parts: (1) computer search PubMed, Embase, Web of Science, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, Medline, Chinese Scientific Journal Database (VIP database), Wan Fang Data Knowledge Service Platform, China National Knowledge Infrastructure and Chinese Biomedical Literature Database; (2) the reference lists of relevant papers; (3) the grey literature sources. The reference lists of relevant papers, especially other literature reviews on the topic, may identify citations which did not appear during a database search. The search process will be assisted by a librarian scientist.

Inclusion criteria

The following were the exclusion criteria:

  1. Participants enrolled in the study met the criteria of being elderly (at least 60 years old), diagnosed with incontinence.

  2. Studies that addressed the risk factors for IAD in older adults.

  3. Research design adopted either a cohort studies, case-control studies or cross-sectional studies.

  4. Published in Chinese or English.

Exclusion criteria

  1. Full texts cannot be obtained.

  2. Case series, duplicate reports, reviews and conference reports.

  3. Repeated publications.

  4. Incomplete literature data present.

  5. Low methodological quality evaluations evident in the literature (Newcastle-Ottawa Quality Assessment instrument (NOS) <4, Agency for Healthcare Research and Quality (AHRQ) 0–3).

After removing duplicates, studies will be uploaded into the Endnote X9 program. Two independent researchers will conduct the study’s initial screening stage whereby all included papers retrieved from electronic databases will be evaluated against the specified inclusion criteria by examining their titles and abstracts. Following this step, the researcher will critically evaluate the full text and relevant attachments of accessible papers that meet the criteria for possible exclusion based on predetermined exclusion principles. Figure 1 depicts the screening procedure for the course of the investigation. All discrepancies will be resolved by consultation with a third investigator.

Figure 1
Figure 1

Preferred Reporting Items for Systematic Reviews and Meta-Analysis flow diagram of the identification, screening and eligibility of included articles.

Data extraction

Two researchers will collect data from pertinent studies using the following criteria during data extraction: (1) author(s) of the study; (2) research time period and publication year; (3) the study’s design; (4) research country or continent; (5) using data sources; (6) demographics and inclusion criteria for study participants, ‘Elderly’ defined, ‘IAD’ diagnostic standards stated; (7) main results; (8) risk factors; (9) ORs and 95% CIs for the risk factors (multivariate regression analysis data are recommended). For unclear details, the researchers will contact the corresponding authors by email for detailed information.

Risk of bias and quality assessment

The NOS for cohort studies and case-control studies will be used by two researchers to independently assess the risk of bias in the included studies. The study will use NOS to assess the quality of case-control and cohort studies. Each section has a total of eight items in three categories, including study population selection, intergroup comparison, exposure and result evaluation. The tool is scored on a scale of 9, with scores of 0 to 3, 4 to 6 and 7 and above considered to be low-quality, medium-quality and high-quality literature, respectively.17 The study will assess the quality of the evaluated cross-sectional study using the evaluation criteria recommended by the AHRQ in the USA, which consisted of 11 items answered ‘yes’, ‘no’ and ‘unclear’. Points of 0–3, 4–7 and 8 or more indicate low-quality, medium-quality and high-quality documents.18

Strategy for data synthesis

In this study, a meta-analysis of risk factors of the included literature will be performed using RevMan V.5.4 software. Continuous variables will be reported as weighted mean squared deviations and 95% CIs, while binary variables will be expressed as ORs and 95% CI. Using the I2 statistic, between-study heterogeneity will be evaluated. If p>0.1 and I2<50%, it would indicate acceptable heterogeneity between studies, which was analysed by fixed-effects model; if p≤0.1 or I2≥50%, it would indicate large heterogeneity between studies, which was analysed by random-effects model, and only descriptive analyses will be performed for studies where effect sizes cannot be combined.19 Differences will be considered statistically significant at p<0.05. We will perform a narrative analysis when quantitative synthesis is not appropriate.

Subgroup analysis

Subgroup analysis will be done when data are available. The groups may be designed based on the care setting, sex, ethnicity, country or region, and economic development conditions.

Assessment of reporting biases

Funnel plots will be used to assess publication bias. We will evaluate publication bias by performing the Begg’s and Egger’s tests. The significant p value (<0.05) indicates the existence of publication bias.

Patient and public involvement

None.

Ethics and dissemination

The findings of this systematic review and meta-analysis will be published in a peer-reviewed journal.

Discussion

Based on our comprehensive search strategy and thorough screening process, this study represents the first systematic review and meta-analysis identify risk factors associated with IAD in older adults. The purpose of this study is to review current information about the risk factors for IAD in older adults. We seek to create data to help physicians and caregivers identify high-risk groups based on recognised universal risk factors by performing a systematic review and meta-analysis. These common IAD risk factors will be screened out to guide how to treat skin problems in senior individuals. The risk factors for IAD in older people have never been the subject of a systematic review and meta-analysis until now.

Our proposed research has several potential limitations. The initial limitation will be that the studies with substantial heterogeneity might not be suitable for use in meta-analysis. Another obstacle concerns varying degrees of socioeconomic advancement and disparities in health services delivery, leading to differing baseline characteristics across geographic locations and medical settings. Disparate measuring instruments employed can result in divergent outcome estimates, thus confounding analysis interpretation. Finally, a major limitation lies in the dearth of studies exclusively concentrated on the older IAD population, with the majority of studies concentrating on patients of all ages. Consequently, due to the small sample sizes, our conclusions about risk factors may be biased.

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