Factors associated with medical devicerelated pressure ulcers occurrence in hospital setting: a systematic review protocol

Pressure injuries (PI) are localized areas of damage involving the skin and/or the underlying tissues, generally over prominent bones. PI are primarily caused by intense and prolonged pressure or pressure in conjunction with friction and moisture.¹ Reduced mobility, advanced age, poor nutritional state, sedation, impaired perfusion, humidity, comorbidities, and the use of certain drugs are the significant risk factors for PI occurrence.² PI are a common complication in bedridden patients with an incidence rate ranging from 0.4% to 38% in acute care settings, from 2.2% to 23.9% in long-term care, and from 0% to 17% in home care.³ The term hospital-acquired pressure injuries (HAPI) refers to those PI arising during hospital stay. HAPI are a relevant indicator of the quality of nursing care⁴ and a significant patient safety issue since their negative impact on quality of life, infection risk, length of stay, and mor-tality.^5–7 Moreover, HAPI contribute to increased health care expenditure with an estimated annual cost of $9.1–$11.6 billion in US⁸ and represent approximately 3%–5% of the total health care spending in Italy, Spain, and UK.⁹ Medical device-related pressure injuries (MDRPI), a peculiar subtype of HAPI, result from the pression exerted by devices (or their fixation systems) applied for diagnostic and therapeutic purposes and mirror the shape and the location of the device itself.¹ MDRPI account for nearly a third of cases of HAPI^10–12 and may interest the skin, the mucous membranes, or both (i.e. mouth/nasal passages, uretral meatus).¹ MDRPI may occur on any tissue subjected to the pressure and the humidity caused by a medical device, regardless, they are more likely to be located in “atypical” anatomical sites including the neck, face, ear, nasal bridge, nostrils, or buccal rima.^11,12 MDRPI severity is ranked according to the National Pressure Ulcer Advisory Panel (NPUAP) classification while mucosal PU are considered unstageable.^1,13 Skin breakdown related to medical devices is described mainly in critical care patients (incidence 0.9%–41.2%, prevalence 1.4%–21%),³ but may also occur in general wards, trauma centers, surgical units, long-term rehabilitation settings, and pediatric units (overall estimated pooled incidence and prevalence respectively 12% and 10%).¹⁴ MDRPI are often underreported or not timely recognized as shown in Apold et al.’s¹⁵ and Kim et al.’s¹⁶ contributions, in which nearly 75% of ulcers were diagnosed at very late stages (3, 4, or unstageable). These data demonstrate the need for knowledge building, raising awareness, and incorporating evidence-based acquisitions into clinical practice to reduce MDRPI burden. The prevention of MDRPI is complicated, as medical equipment is often an essential part of the treatment. In fact, a recent NPUAP consensus statement defined some situations in which such MDRPI may be unavoidable: (a) when it is medically contraindicated to adjust, relocate, or pad underneath a therapeutic device; (b) when a life-sustaining vascular access or other medical device precludes turning and positioning; (c) when underlying edema or uncontrollable moisture under device compromises tissue tolerance to pressure/shear forces.¹⁷ Two recent systematic reviews with metaanalysis synthetized the incidence and prevalence of the problem among hospitalized adult and pediatric patients and sought to identify the medical devices mostly associated with the risk of MDRPI.^14,18 However, the results achieved should be interpreted with caution primarily owing to the methodological limitations of the existing literature and the heterogeneity between the analyzed works.¹⁹ The literature examining risks for MDRPI remains sparse and reported risk factors vary between studies. To guide effective evidence-based interventions aimed at reducing MDRPI, it is important to increase knowledge and understanding of potential risk factors.

Given these premises, we decided to undertake a new systematic review of the existing literature regarding the phenomenon of MDRPI in hospitalized adult patients. Our principal purpose is to retrieve evidencebased acquisitions regarding MDRPI onset and possible risk factors. This work’s strength relies on an extensive and in-depth search of available scientific literature, including dissertations, theses, and conference papers. The inclusion of works irrespective of the language and country of publication allows us to overcome external validity limitations. Moreover, the rigorous methodology we are going to use warrants the retrieval of the best results for the development of clinical practice recommendations.

Primary research question is:

What factors are associated with the occurrence and development of MDRPI in adults admitted to hospitals?

Secondary research questions are:

What is the extent of the problem (prevalence/incidence) considering all medical devices, and, if it is possible, distinguish each device separately?

The primary research question was then summarized and defined according to the PECO framework,²⁰ as shown in Table 1.

Our protocol presents the methodological approach of a systematic review that will retrieve possible risk factors related to the occurrence of MDRPI through evidencebased acquisitions. The strengths of this work are based on an extensive and thorough search of the available scientific literature, including dissertations, theses, and conference papers. The inclusion of papers irrespective of language and country of publication allows us to overcome the limitations of external validity. In addition, the rigorous methodology we use will ensure the retrieval of the best results for the development of clinical practice recommendations. The use of systematic methods in following the PRISMA-P guidelines and the pre-specification of methods in a protocol will also be an advantage for the systematicity and transparency of the review. Therefore, we are confident that the results of this review will improve the quality of care provided and provide directions for further research.