This study demonstrated that healthcare professionals exhibited a high level of tolerability and acceptance towards the ABHR, in alignment with the WHO protocol for evaluation of tolerability and acceptability of ABHR [15].
This study is important as it provides justification for the continuous utilization of an evidence-based, cost-effective intervention for a reliable supply of HH product at the point of patient care. This is in line with WHO's multimodal HH improvement strategy [9] and the recently published WHO research agenda for HH in health care [27]. The insights garnered from this study are particularly valuable for informing policy and strategic decisions to finance the production of local ABHR and inclusion of ABHR in countries EML and EMLc to strengthening IPC programmes within healthcare settings in LMICs like Sierra Leone. These settings often grapple with maintaining and optimizing IPC programs at both national and facility levels, with regards to the availability of essential consumables such as soap, ABHR, and Personal Protective Equipment (PPE) [17, 28–30].
There are several methodological strengths to the study. Firstly, the adherence to the WHO standardised protocol and quality benchmark criteria facilitates comparability with other studies, and enhanced the robustness of our findings. Additionally, consistency in the objective evaluation by employing the same trained observers across all three visits improved the internal validity by minimizing observer bias in the objective assessments of participants. Finally, the inclusion of secondary and tertiary hospitals, and a wide array of professional categories, provided a comprehensive overview of hygiene behaviours among health workers.
Despite these strengths, this study has some limitations. The exclusive use of a single test product, as prescribed by Method 1 of the WHO protocol, precluded the comparison against multiple products. To address this gap, we advocate for subsequent research utilizing Method 2 of the WHO protocol for the evaluation of tolerability and acceptability of ABHR, which allows for such comparative analysis. Additionally, this study does not validate product consumption as an indirect measure of hand hygiene best practices and behaviour, indicating the need for further research in this area.
Our study found that the locally produced ABHR met the criteria for user tolerability for all assessment items according to the WHO single product evaluation protocol. The objective evaluation of the state of skin on hands by the trained observer showed increasing scores in each visit up to 100% in proportion to score > 2 (WHO benchmark) similar to the findings of a study by Wolsfensbergeret et al., who used the same WHO protocol [25]. Similarly, subjective evaluation of the state of the skin by health workers also underscored the product’s high tolerability, with the “Overall skin integrity” of 97% and 98% by the second and the third visits respectively. These figures are in concordance with the findings by Tarka et al., where more than 95% of participants reported favourable tolerability outcomes [24]. Moreover, the self-assessment of skin condition by health workers consistently surpassed WHO benchmarks for each criterion for skin tolerability.
The test product met the acceptability threshold for all criteria except for the “drying effect”, which did not achieve the requisite benchmark established by the WHO protocol. This benchmark requires over 75% of the participants to rate the product with scores above 4. Contrary to our observations, Wolsfensbergeret et al. reported a satisfactory “drying effect” for their investigational product, albeit failing to meet WHO acceptability criteria for “texture” and “speed of drying” [25]. In our study, participants reported the product had a high “drying effect” on the skin of the hands, although this was not as pronounced as the drying effect associated with the use of soap and water [31]. In actuality, alcohol-based handrubs should not (if used correctly) dry the hands because they contain skin softeners (emollients). In the case of our test product, the locally produced ABHR (test product) was based on the WHO formula 1 containing 98% Glycerol at a final concentration of 1.45% (v/v), to increase the gentility of the product to hands. However, the production guideline cautioned for strict adherence to concentration metrics to prevent less or excess humectant effect that may result in dryness, dermatitis or stickiness of hands as reported in other previous studies [25, 32, 33]. This observation from our study possibly suggests the need for special consideration of the concentration of glycerol recommended in the WHO Formal 1. Findings in support of using lower glycerol concentration were reported in another study which recommended 0.5% glycerol instead of 1.45% in tropical climate settings like Sierra Leone [32]. Interestingly, our study found that “colour” was more favourably perceived compared to “smell”, although both met the WHO acceptability standards; this echoed the findings from other similar studies [24, 25]. However, anecdotal feedback from participants indicated a preference for mitigating the wine-like odour associated with the product’s ethanol content, suggesting the addition of a fragrance may enhance acceptability while maintaining its efficacy and quality. This underscores the notion that optimal acceptability may be achieved by providing healthcare workers with a selection of products, allowing for personal preference and thereby increasing adherence to hand hygiene protocols [23].
Addressing the challenge of suboptimal HH compliance necessitates a multifaceted strategy that extends beyond simply ensuring access to essential supplies such as ABHR. It demands the incorporation of supplementary interventions targeting the underlying determinants of compliance, including social influences, attitudes, and behaviours. This comprehensive approach aligns with the WHO advocacy for a multimodal strategy to improve HH practices [34].
Our study described the participants' HH behaviour based on the set of HH promotion and practice variables on the same WHO protocol and verbal feedback recorded by observers during the evaluation sessions. Although most participants believed they could improve their HH compliance, forgetfulness and lack of time were the major limitations as previously reported in other studies [24, 35, 36]. During the study period, 55% of participants reported having used handrub to clean their hands during the last five HH opportunities. Notably, more than half (63%) of the health workers adhered to HH in more than 90% of recommended instances. This performance was better than that documented by a study conducted between 2007 and 2015 in which 42% of nurses reported usage of ABHR in more than 90% of opportunities [37]. Most of the participants of our study felt very positive about the test product and preferred it to the usual product used by the hospitals. Even though a significant proportion of the participants perceived that the test product could improve their HH compliance and enjoyed carrying along the 500ml bottle containing the test product in their bags or pockets, this perception does not automatically translate into consistent HH practices. This observed behaviour might be partially influenced by the participants' awareness of being part of a study and their conscious efforts to comply with the study's expectations, potentially leading to a distortion commonly referred to as the Hawthorne effect [38, 39]. The Hawthorne effect suggests that individuals alter their behaviour in response to their awareness of being observed, which could skew genuine practice patterns. Therefore, while the introduction of intervention might initially seem to enhance practice, such improvements should be cautiously interpreted, acknowledging the possible influence of observational biases on reported HH compliance rates. This underscores the importance of considering both the psychological and behavioural dimensions when evaluating the impact of HH interventions, to ensure a holistic understanding of compliance dynamics within healthcare settings.
The mean quantity of ABHR product used by daily shift was 71.6 ml (SD ± 35) and the median (65.1 ml). Our study recorded higher consumption of the test product compared to other studies [33, 40]. The double-blind, randomized, crossover trial of 3 hand rub formulations by Pittet et al. reported the mean amount of product used per daily shift was 54.9ml (SD ± 23.5 ml) [33]. Nurses (mean = 80.1ml) and medical doctors (mean = 74.0ml) in our study recorded the highest daily consumption of the tested product among the various professional categories of health workers. The possible inference is that nurses have more HH opportunities because of their higher patient-contact time (average 6–8 hours).The cadre with the least consumption were the pharmacists (mean = 33.1ml); this is in tandem with their minimal patient-contact time as they are not routinely involved in direct patient care like nurses and doctors. Conversely, midwives (mean = 36.4ml) preferred to use soap and water instead of the ABHR; this was likely because of their work environment (delivery rooms) and the higher propensity for visibly soiled hands. Despite the high daily usage of the tested ABHR product among the nurses and doctors, we cannot correlate the consumption with hand hygiene to compliance. However, authors in a recent study used multivariable regression analysis to show that direct observation of hand hygiene practices was independently associated with an increase in ABHR consumption [41]. In contrast, another study showed no correlation between HH compliance rates and quantity of ABHR consumed [42].