Translation, Cross-Cultural Adaptation, and Validation of the Munro Scale in Italian

According to the Agency for Healthcare Research and Quality, pressure ulcers/injuries affect nearly 3 million citizens in the United States each year. The Agency also reports an 80% increase in hospitalizations between 1992 and 2006, increasing the annual cost of treating pressure injuries to $11 million.¹ In the United Kingdom, more than 700,000 patients are affected by pressure injuries each year, causing hospital stays of an average of 5 to 8 days per pressure injury, which means an extra annual cost of £3.8 million for the National Health Service.² In Italy, about 10% of hospitalized patients develop pressure injuries.³ Hospital-acquired pressure injuries, damage to the skin and/or underlying tissue,⁴ can have a major negative impact on patients, payors, and health care systems.⁵ According to the National Pressure Injury Advisory Panel (NPIAP), the number of pressure injuries with an onset in the operating room account for 45% of all hospital-acquired pressure injuries.^6,7

According to a 2015 survey conducted by Sørensen et al,⁸ positioning patients who are under anesthesia during surgery is difficult, especially for prone, lithotomy, and lateral positions. Surgical team competence, the availability of positioning equipment, and organizational issues were also found to affect positioning problems. Proper patient positioning aims to ensure patient safety, surgical site access, and reduction of the risk of developing nerve and tissue injury.⁹ Surgical patients are at high risk of developing pressure injuries because of immobility during surgery and throughout the postoperative period.^10,11 In addition to immobilization, inadequate nutrition is also a risk factor in the postoperative phase.¹²

Pressure injuries in surgical patients have been reported to appear between 48 and 72 hours after surgery.^9,10 Therefore, the incidence of intraoperative pressure injuries is likely to be underreported.¹³ In a prospective cohort study to identify prevalence and risk factors of pressure injury development in surgical patients, Primiano et al¹⁴ reported that the rate of intraoperatively acquired pressure injuries was in the range of 12% to 66%.¹⁴ In a retrospective chart review by Engels et al,⁶ 15 of 60 patients undergoing surgery pressure injuries within 1 week of their perioperative stay. Health care providers in an operating room must learn how to identify patients at increased risk of perioperative pressure injuries. This preoperative assessment would enable nurses to take the possible actions to prevent this occurrence.⁶

The Munro Pressure Ulcer Risk Assessment Scale for Perioperative Patients – Adult (Munro scale) is a standardized assessment tool designed to assess the risk of developing pressure injuries before, during, and after surgery.¹⁵ The assessment scale is designed to facilitate identification of at-risk patients and implementation of preventive measures.¹⁵

Other scales, such as the Norton, Waterlow, or Braden, were not designed for surgical patient risk assessment, do not include surgery-related risk factors, and have a low predictive value and low sensitivity for perioperative pressure injuries.^10,16 He et al¹⁷ performed a meta-analysis for predictive validity, including the calculation of pooled sensitivity, pooled specificity, diagnostic odds ratio, construction of summary receiver operating characteristic curves, and overall diagnostic accuracy. Although the observed heterogeneity between studies may have affected the results, the low values for overall diagnostic accuracy (Q*) and diagnostic capability indicated that the Braden scale has low predictive validity for the risk of pressure injuries in surgical patients.¹⁷

The Munro scale has also been translated into Chinese¹⁸ and Turkish.¹⁹ Li et al¹⁸ conducted a cross-sectional study on the reliability and validity of the Munro scale. In this study, a total of 246 surgical patients were enrolled through convenience sampling and were surveyed at a hospital from July 2016 to March 2017. Interrater reliability was determined by the intraclass correlation coefficient (ICC). The ICC of each item in the Munro scale ranged from 0.786 to 1.0. The ICC for the total score of the Munro scale was 0.954 (95% confidence interval, 0.929-0.971). The content validity was determined by the content validity index (CVI), and the results showed that the I-CVI ranged from 0.6 to 1.0, and the S-CVI was 0.947.¹⁸ Gül et al¹⁹ adapted the the Munro scale for use in Turkey and tested its validity and reliability with a sample of 188 surgical patients. They concluded that the scale can help nurses identify patients at low, medium, and high risk of developing pressure injuries in the preoperative, intraoperative, and perioperative periods.

The aim of the current study was to translate the Munro scale into Italian and assess its cross-cultural content and face validity.

Study design. The study was conducted following a biphasic validation methodology: Italian linguistic-cultural validation (phase 1) and content and face validation (phase 2). The translation and cross-cultural adaptation process adhered to World Health Organization guidelines²⁰ including forward translation, expert review, and back translation. Health care professionals with a minimum of 5 years' experience working in the operating room of different hospitals were invited to participate in a content and face validation of the translated instrument. The method used is shown in Figure 1.

Description of the Munro scale. The Munro scale assesses the surgical patient in the preoperative, intraoperative, and postoperative phases, followed by a summary section in which the variables and scores are calculated.¹⁵ Risk factor assessment and scores are cumulative. The result of each assessment phase yields a low-, medium- or high-risk score. The calculated risk score during the perioperative period is determined by the sum of the risk factors.

Preoperative risk assessment includes 6 risk factors: mobility, preoperative fasting, body mass index (BMI), history of weight loss, age, and comorbidities. Each variable is assigned a score of 1, 2, or 3. Cutoffs and reference intervals are given for each variable. The sum of all the risk factors yields the total Munro score, determining the preoperative level of risk. The level of risk is classified as low (score between 5 and 6), moderate (score between 7 and 14), or high (score 15 or higher).

The intraoperative risk assessment includes physical status/American Society of Anesthesiology score, anesthesia type, changes in body temperature, episodes of hypotension, skin moisture levels, surface/motion variables, and patient position. Each variable is assigned a score of 1, 2, or 3. Cutoffs and reference intervals are given for each variable. The intraoperative sum of scores ranges from 7 to 21 and is added to the preoperative score, yielding a risk level of low (score 13), moderate (score between 14 and 24), or high (score 25 or higher).

The postoperative risk assessment includes perioperative duration and blood loss. Each is scored using a 3-point descriptive rating scale. The sum of the postoperative and intraoperative total score yields the total Munro risk score, grouped as low (15), moderate (scores between 16 and 28), or high (29 or higher).

Phase 1. Forward and backward translation and Italian linguistic-cultural validation. In the first phase, a linguistic-cultural validation was performed by adopting the standard translation, back translation, and forward translation methodology.²¹ Before proceeding, permission was obtained from the creator of the Munro scale, who also confirmed that, to the best of her knowledge, the scale had not been yet translated into Italian. The resulting Italian version of the Munro Scale was named MUNRO-IT.

The translation from English to Italian, including consideration of cultural aspects, as well as the back translation (from Italian to English) were completed independently by 2 experts in both languages who also have medical backgrounds. The experts did not know each other and had no contact with each other while performing the translation. The two translations were compared and merged into a single version through a consensus discussion involving a panel of 4 experts, 1 surgeon, 1 operating room nurse, and 2 academic researchers, one of whom is a native English speaker (forward translation). At the end of the consensus discussion, the experts were asked to rate each item for its fidelity and ease of understanding on a 4-point Likert scale from 1 (disagree) to 4 (strongly agree). Consensus on the translation was calculated using Fleiss’ kappa statistical measure, setting 0.70 as the cutoff value.²² The final Italian version was then translated back into English by a third expert with a medical background, who had not seen the document before and had no contacts with the other 2 experts who had worked on the forward translation. Once back translated into English, it was sent to the creator of the original Munro scale for comparison with the original version. The creator confirmed the semantic equivalence between the 2 tools.

Phase 2. Face and content validity.

Step A: content validity. To evaluate content validity,²³ 50 operating room nurses in 2 separate urban hospitals in northern Italy were invited to participate in the content validity study. Inclusion criteria included being a registered nurse with at least 5 years' experience in the operating room. Of the 50 nurses invited, 12 (24%) agreed to participate. These 12 nurses received an email with information about the study, informed consent, and the MUNRO-IT scale. They were asked to provide demographic and background information (age, sex, years of nursing and operating room experience, and educational background) and to rate the relevance of each scale item using a 4-point Likert scale, ranging from 1 (not relevant) to 4 (very relevant).

Content validity index calculations. The content validity index (CVI) was calculated as the ratio of the frequency of 3 and 4 scores. A CVI value of 0.90 or higher was considered confirmation of content validity.^24,25

Step B: face validity. Face validity refers to the transparency or relevance of an instrument to both respondents and examiners.²⁶ A non-probabilistic consecutive sampling technique was used to invite a panel of operating room experts to evaluate the face validity of the MUNRO-IT. Participants invited included surgeons, anesthesiologists, and nurses from 2 urban hospitals located in northern Italy, but not the the hospitals chosen for the content validation study. Only health professionals with at least 5 years of operating room experience were eligible to participate. A total of 30 potential participants were invited (10 physicians and 20 nurses). Of these, 4 physicians and 7 nurses agreed to participate (36% response rate) and were sent an e-mail containing information about the study and the MUNRO-IT instrument. A structured questionnaire interview was conducted with all participants. Using a 4-point Likert scale ranging from 1 (unclear) to 4 (very clear), participants were asked to rate the clarity and comprehensibility of each item. Clarity was defined as “unambiguous terms,” and comprehensibility was defined as “terms used whose meaning is easily understood.”

Ethical considerations. The research methodology adopted in this study fully complied with the international ethical principles of the Declaration of Helsinki, in accordance with good clinical practice.²² This study adhered to all ethical assumptions guiding research with human participants. Written informed consent was obtained from all participants (nurses, physicians, and translators). Their participation was voluntary, and their identity and the information provided was kept confidential according to data protection law.

Linguistic-cultural validation. The versions translated by the 2 translators, T1 and T2, into Italian were analyzed by 4 authors of this study to achieve consensus. The authors observed a good concordance of the translation. Differences in the translation of 7 words/descriptions were resolved. See Table 1. After matching the 2 versions and adjusting some words, the final version of the tool was obtained. Another mismatch across all the forms regarded the signature field; where T1 used the translation “Nurse Signature,” T2 translated this as “RN Signature.” The inter-rater agreement Fleiss’ kappa index was 0.95.

Content and face validity. Sixty-seven percent (67%) of the 12 phase 1 content validity panel members were female and 33% were male, with a average age of 45.8 years (SD ± 8.85). Of the respondents, 58% had a bachelor’s degree in nursing and 42% had a associate’s degree. The average number of years of operating room experience was 14.6 (SD ± 9.39). Sixty-seven percent (67%) of respondents were nurse anesthetists, 25% were scrub nurses, and 8% were circulating nurses. See Table 2.

The CVI of all items was 0.91, meaning that 91% of the experts agreed on the relevance and representativeness of the tool. The items with a low CVI were body temperature, moisture, and surface motion. The items with a CVI of 100 were mobility, nutritional state, BMI, weight loss, age, comorbidity, preoperative Munro score total, preoperative level of risk, American Society of Anesthesiology score, anesthesia, hypotension, position, intraoperative score subtotal, adding preoperative Munro score total for a cumulative total, intraoperative Munro score total, intraoperative level of risk, lengh of perioperative duration, blood loss, postoperative score subtotal, adding intraoperative Munro score total for a cumulative total, postoperative Munro score total, and postoperative level of risk.

Forty-five percent (45%) of 11 volunteers who participatated in face validation (phase 2) were female and 55% were male, with an average age of 48 years (SD ± 11.7). The majority of the nurses had a bachelor’s degree or postgraduate certificate in nursing (62%). The average number of years of experience was 22.63 (SD ± 12.6), and experience in the operating room averaged 21 years (SD ± 12.8). Twenty-seven percent (27%) of respondents were scrub nurses, 18% were surgeons, 18% anesthetists, 18% circulating nurses, and 18% nurse anesthetists. See Table 3.

The scores for all items were ≥ 3 (ie, clear or very clear) for comprehensibility and clarity. With respect to clarity, 40% of the items were rated as very clear (4) and 60% were rated as clear. Similarly, for comprehension, 48% of the items were rated as very clear (4) and the remaining 52% were rated as clear. See Figure 2.

At this stage, participants also were asked to add new elements, if deemed necessary, and to provide comments for each item. No additional suggestions or comments were made.

Identifying patients at increased risk of perioperative pressure injuries is extremely important. A review of the literature revealed several scales dedicated to assessing the risk of pressure injuries, but none of them were in Italian and/or focused on pressure injuries in the operating room.^27-29 The Munro scale consists of 25 items regarding risk factors such as BMI, anesthetic risk (American Society of Anesthesiology score), position adopted on the operating table, blood loss, and operating time. This specificity distinguishes it from other scales, such as Waterlow’s, Braden’s or Norton’s scales, because it was specifically designed for surgical patients.¹⁵ The Italian version of the Munro Scale (MUNRO-IT) has the same domains as the original tool, and the results of this study confirm its face and content validity.

No issues about the translation were raised during the first phase of this study. Regarding the translation, solid agreement was reached between evaluators, showing a high level of agreement with the comprehensibility of items. The CVI was 0.91, meaning that 91% of the experts agreed when assessing content validity. In this phase, only 1 expert communicated values below average for items concerning body temperature, humidity, and surface/mobility. However, since the CVI indices were in general very good, the authors decided to keep these items as they were.

The high interrater reliability of the translated instrument, content validity, and face validity scores suggest that the MUNRO-IT can be used safely in Italy for the assessment of perioperative risk related to the development of pressure injuries in surgical patients. The authors believe these results are promising for further validation studies. In addition, the approach of using 2 multiprofessional expert panels as assessors for phase 2, focusing on content and face validity, ensured the relevance and representativeness of the tool in relation to the content domain. In fact, the score derived from face validity was well above the 75% acceptable limit.²⁵

A more extensive evaluation of the MUNRO-IT scale with hospitalized patients, most importantly prospective validity, was not possible because of the COVID-19 pandemic emergency. However, the authors believe that this preliminary assessment and linguistic validation is promising for use in operating room and surgical departments by health professionals in Italy.

The Munro scale has been translated in other countries, where health care organizations and policies are very different from Italy. This makes comparison of the MUNRO-IT and other translations difficult, also due the the study populations involved and the different educational backgrounds of operating room nurses.

Following translation and linguistic adaptation of the Munro Scale in Italian, the results of the content and face validitation study conducted with experienced health care professionals who work in the operating room suggest that the translated instrument can be used safely in Italy. However, further studies are needed to support the reliability as well as the content and prospective validity of the Italian version of the Munro scale.

The authors thank all the health professionals, physicians and nurses, who, despite the COVID-19 pandemic and the resumption of surgical activities, agreed to contribute to this research and participate in this validation study. The authors also thank the native translators who contributed to the back translation process.

Mr Bruno is a scrub nurse, Regina Montis Regalis Hospital Mondovì, Italy. Mr Bertolino is an engineer, Tobin SRLS, Mondovì, Italy. Dr Garbarino is a risk manager ASL 2 Savonese, San Paolo Hospital, Savona, Italy. Dr Munro is a professional practice and care experience manager, B.E. Smith, Santa Monica, CA. Dr Barisone is a research fellow, Department of Translational Medicine, University of Piemonte Orientale, Novara, Italy. Dr Dal Molin is an associate professor, Department of Translational Medicine, University of Piemonte Orientale, Novara, Italy.

Address all correspondence to: Michela Barisone, RN, MNS, PhD, Via P. Solaroli 4, 28100 Novara. University of Piemonte Orientale, Novara, Italy; email: michela.barisone@uniupo.it