Study of knowledge, perception, and practice of patients regarding fasting requirements for blood glucose testing

Background: Patient preparation is one of the least standardized parts of the preanalytic phase oftesting. Fasting blood glucose requires fasting for 8-12 hours as per various guidelines and also hasseveral other requirements. Lack of communication, understanding, or compliance regarding hours-of-fasting, water-intake, avoidance of caloric snack/beverage, the sudden change in smoking,exercise, alcohol, medication, etc. introduces preanalytic errors. Method: To evaluate awareness,understanding, and compliance with fasting requirements, a face-to-face survey was done onoutpatients in a Government Hospital in Pali, Rajasthan, India. Relatively more educated internetusers were surveyed as controls through an online SurveyMonkey tool. Results: 98 patients and187 controls participated in the study. Perception about fasting requirements ranged from 0-17hours. 71% of patients and 35% of controls perceived that nobody explained to them the durationor nature of fasting. The different sources of information had been used in different proportions bypatients and controls. For imparting understanding and compliance about duration, and otherrequirements of fasting, the instruction was usually incomplete but still much more effective (p-value=0.000002) than formal education level (p-value=0.024). Conclusion: 71% of patients and35% of controls did not receive instructions for fasting. 40% of those instructed showed bettercompliance, but awareness was incomplete. The instruction was more effective than formaleducation in improving awareness and compliance. Improved awareness was strongly associatedwith receiving instruction and weakly associated with formal education but financial status showedonly a weak negative association.


Introduction
The preanalytic phase, i.e. the series of steps before the actual testing of a laboratory investigation, is known to incur significantly more errors (50-70%) than the analytic (5-15%) and the post-analytic phases (10-30%) [1]. The regulated environment of the laboratory and the implementation of rigorous quality controls have more than decimated the analytic errors. However, the pre-analytic and postanalytic phases are much less regulated, especially at the extreme ends of the process loop (the brainto-brain loop) [1,2]. A particularly problematic area of the preanalytic phase involves those requiring patient preparation [3].
Fasting is the most well-known type of patient preparation for diagnostic medical testing. Though a multitude of laboratory parameters are significantly affected by fasting state, e.g. glucose, triglyceride, insulin, alkaline phosphatase, bilirubin, iron, C- and are not adequately communicated or explained to patients [10,11]. "Fasting" in laboratory science is not merely a term that is intuitive from its face value and is different from other forms of medical fasting eg "Nil Per Oral (NPO)" before surgery or endoscopic procedures etc. Depending on the test, fasting requires specifying the duration and a list of allowed/desired and prohibited types of activities before and during the fast [4].
For example, the fasting duration for fasting blood glucose may vary from 8-12 hours (usually overnight) depending on country and guideline [4,12]. It also requires 24 hours of alcohol restriction. Any caloric intake in the form of solid or liquid is prohibited during the total duration of fasting. Smoking, exercise, chewing gums, and taking nonessential medication in the morning before sampling is discouraged [13]. However, hydration in the form of clear water is allowed or rather encouraged, and thus it is very different from NPO.
When fasting blood glucose is a part of an OGTT, it needs to be even more stringent [14].

Materials and Methods
The study was conducted after permission from the     Among the controls 27% thought tea/coffee is allowed, 10% thought snacks are allowed and 3% thought religious food was allowed. Thus, controls also had misconceptions, but to a much smaller extent than patients.  under-fasting, they had statistically better performance than patients in terms of hours of fasting required. When plotted as a continuous variable, perception of hours of fasting duration needed for glucose was lower than the target (8-12h) in both patients and controls (i.e. majority reported under-fasting), but patients (3.4±4.9h) had a significantly lower duration than controls (5.4±3.7h) and the difference was highly significant (Student's t-test p-value=0.0004)  In the combined population of patients and controls, educational categories were cross-tabulated against fasting duration categories.  Chi-Square analysis (Table 7 and 8) showed that knowledge of proper fasting duration had a significant association with a better education. However, clubbing the different types of misconceptions about durations into a single improper duration category leads to a partial loss of significance, mainly because the relatively more educated people tended to cluster within one subtype (under-fasting) of the improper duration of fasting, and less educated people had higher tendency to be in another subtype (non-fasting).
Overall knowledge was classified into 4 ordinal categories: scored as 3 if conditions and duration both all known, 2 if conditions were known but duration not known, and 1 if only duration known and 0 if neither is known.

Discussion
Though the exact degree of reliance on medical decisions on laboratory investigations is difficult to delineate [17] its criticality is unquestionable. Poor investigation results lead to misdiagnosis and contribute to the burden of morbidity and mortality in many ways. Preanalytic variability, though relatively less standardized than the analytic phase, has several components that have been investigated for decades. However, patient preparation, though the most obvious and unavoidable, is still one of the most neglected components of the pre-analytic phase [18].
India is the "diabetes capital of the World" [19] with 45 million diabetics (15% of the world's burden) living in this country. Rajasthan is the largest state in India that historically had a very low prevalence of diabetes (<5% in 1990). However, Rajasthan has shown an alarming jump in diabetes prevalence, increasing by 28-36% in the period 1990-2016 [20]. Diagnosis and monitoring of diabetes become all the more important in this context, which critically depends upon the quality of glucose testing, which includes the quality and duration of the fasting.
In this study, it was found that a large majority (71%) of our patients and a third of our educated controls did not remember receiving fasting instructions for glucose. Patients are on average less educated in formal school education (Table 1) but more affluent ( properly prepared (Figure 1 and Table 6).
Education and instruction both make a significant impact and are associated with a better understanding of duration and other conditions. However, the uniqueness of the present study is that the ability to see the significance levels of the impacts. It was found that instruction was way more significant (Table 9: p-value=0.00000179) than formal education (Table 10: p-value=0.024) in imparting the awareness about specific medical information regarding fasting.
In contrast to formal education, financial status ( Fig. 2) did not have any positive association, but interestingly had a weak negative association with the total knowledge about fasting (Chi-Square borderline significant but Spearman correlation not significant). This finding suggests people who are financially more affluent are likely to be somewhat less complaint.
Instruction overall in the present study had only about 40% final effectiveness which suggests that there is a lot of scope of improvement in improving the content of the instruction and their modality of implementation. The high apparent awareness and compliance about alcohol and smoking found in the present study were likely false due to the shame of disclosure.
The lack of knowledge and poor compliance is partly amplified due to the diffuse responsibility of all stakeholders involved in the total testing process. The poor outcome testifies that, whether the information was provided or not, it was not retained well or adhered to. Some guidelines [3, 13] have recently been formulated to standardize the delivery of patient preparation information.
It is counterintuitive that under fasting may not always lead to higher estimates of glucose levels.
Reactive hypoglycemia is seen in many conditions including early diabetes where a post-prandial sample may show glucose level relatively lower than fasting [21,22]. Thus the pre-analytic error introduced by the lack of instruction, understanding, or compliance in different aspects of fasting is complex and cannot be normalized post-analytically by some correction formula even if the current study retrospectively knew the exact error in the patient preparation. The primary way to prevent the error would be to improve the content, quality, intensity, and frequency of the information delivery to the patients and updating the training of their caregivers of all levels through as many means as possible.
While the physicians and policymakers involved in developing guidelines formulate the need for fasting and are responsible for systematically increasing public and professional awareness, it is the It should add to the literature used to formulate better harmonized preanalytic guidelines, and also it should lead to quality improvement interventions aimed at better percolation and implementation of the guideline at the grassroots levels.
Regarding patient preparation aspects of preanalytic clinical biochemistry, there are no published studies from India and very few studies exist Internationally [24,10,18,11,25]. One of the very few studies on a related topic from another Lower Middle Income Country (LMIC) [26] that could be located was Pant et al study from Nepal, [25] also points to a lack of harmonized definition and protocol for fasting.
A preanalytic survey done by one of the leading groups of the European Federation of Laboratory Medicine (EFLM) [10] found 52% of the patients were not informed about fasting and the rest 48% were also only partly informed.
The present study contrasts with this European study where baseline awareness for fasting was much higher, and rather some of the European subjects believed fasting was necessary for all tests.
Another study from Australia [24] found that the female gender was associated with better patient understanding but the female gender did not show any difference in the present study.
A 2012 report by the European Commission [27] showed that the communication barrier between physicians and their patients was partly due to physicians' availability or time to explain. There should be clear policies for sample acceptance rules for fasting samples. "No-sample is better than a bad-sample" principle should be strictly enforced and re-training of the laboratory personnel should include an emphasis on this.
What does the study add to the existing knowledge?
The current study raises an alert that the present system of information delivery to patients is not able to achieve its intended goal. Revised recommendations should be more harmonized and include precise and practically executable requirements for patient preparation. For fasting blood glucose testing, the time of the day (7-9 AM), the exact range of fasting duration (8-12hours), and water consumption ad libitum, should be specified.
At least verbal explanations to avoid religious snacks during fasting should be provided to help clarify the difference between medical fasting and religious fasting. Alcohol avoidance for 24 h, abstinence from cigarette smoking and avoiding exercise in the morning, and strict restriction of calorific or stimulating beverages including tea, coffee, etc. should be promulgated.