The importance of human factors in therapeutic dietary errors of a hospital: A mixed-methods study.

An accurate therapeutic diet can help people improve their medical condition. Any discrepancy in this regard could jeopardize a patient's clinical condition. This study was aimed to determine prevalence of dietary errors among in-patients at an international private hospital's food department, and to explore causes of error to suggest strategies to reduce such errors in the future. Thus, a sequential explanatory mixed-methods study was carried out. For the quantitative part, secondary data were collected on a daily basis over one-month. For qualitative data, errors arising during the meal flow process were traced to the source on the same day of error followed by qualitative interviews with person responsible. Quantitative data were analyzed in SPSS v.25 as percentages. Qualitative data were analyzed by deductive-inductive thematic analysis. Out of a total of 7041 diets, we found that only 17 had errors. Of these, almost two-thirds were critical. Majority of these errors took place during diet card preparation (52.94%), by dietitians (70.59%), during weekdays (82.35%), breakfasts (47.06%), and in the cardiac care ward (47.06%). The causes identified through interviews were lack of backup or accessory food staff, and employee's personal and domestic issues. It was concluded that even though the prevalence of dietary errors was low in this study, critical errors formed majority of these errors. Adopting organizational behavior strategies in the hospital may not only reduce dietary errors, but improve patients' well-being, and employee satisfaction in a long run.

Introduction

The World Health Organization (WHO) defines patient safety as “a health care discipline that emerged with the evolving complexity in health care systems and the resulting rise of patient harm in health care facilities” [1]. The goal of patient safety is to prevent and minimize risks, errors, and harm to patients while providing health care [1]. Some of the examples to threat of patient safety include, but not limited to, medication errors, health-care associated infections, unsafe surgical procedures, diagnostic errors, radiation errors, sepsis, etc. [1]. Healthcare organizations strive to deliver quality and safer healthcare to patients to ensure optimum treatment outcome which reflects on the quality of the hospital and its staff [2]. This is why patient safety is one of the important components identified by Institute of Medicine (IOM) and WHO that outline principles for the healthcare organizations to provide quality healthcare to the patients [3], thus minimizing preventable harm and reducing risks during the delivery of healthcare [4,5]. A complexity health-care system makes humans more vulnerable to errors [1]. It is estimated that 10% of patients in high income countries face preventable adverse events during their hospital stay [5]. In low-middle income countries, the adverse health events during hospital stay result in 2.6 million deaths annually [5]. Dietary errors are one of the main preventable risks to patient safety [6-8]. Dietary errors are defined as meals containing one or more therapeutic dietary items other than the recommended one [6]. According to a study in Australia, 8% dietary errors were recorded in the hospital’s food delivery system [6]. Another similar study reported that about 20% of the therapeutic meals served to in-patients in a metropolitan tertiary hospital, were inaccurate and 64.8% of these errors were critical in nature that could claim the life of a patient [8].

A therapeutic diet is one of the essential components of latest clinical treatment [9]. Patients are prescribed these diets to cope with and/or recover their health while being admitted in hospital [10], [11]. Therefore, therapeutic nutrition plays a key role in recovery of patients [12]. On the other hand, provision and consumption of inaccurate therapeutic diet could interfere with the patients’ treatment and may pose a threat to their wellbeing [10,11,13]. For example, a patient who is advised a liquid diet, receives and consumes a semi-solid diet. There are critical and non-critical diet errors depending on the severity of the side effects it inflicts on patients’ health. A patient receiving a food item which a patient is allergic to is a critical diet error. Critical diet errors can result in severe deterioration of a patient’s health and may even cause death. Another instance could be that consumption of a thick texture food by a patient on liquid diet could end result in aspiration or choking, or consumption of high fiber diet by a patient who is on low fiber diet could exacerbate the gastrointestinal disease. Allergic reactions could also be a serious adverse effect of consuming incorrect therapeutic diet. Therefore, it is imperative that these errors do not go unchecked.

The computerized system has shown to minimize errors in the hospitals’ meal delivery process [6]. However, errors are inevitable even in the computerized systems as these systems are operated by humans and to err is human. This study reports an account on the accuracy of meals delivered to in-patients, needing a therapeutic diet, admitted in one of the top international for-profit hospitals with strictly implemented American hospital standards. We aim to assess the prevalence of errors in the provision of therapeutic diets to in-patients, and to explore the underlying causes to suggest strategies to reduce the chances of such errors. We expect that this study will serve as a guide to enhance patient safety, improve patient satisfaction, and effectiveness of the meal delivery systems in international level hospitals located in low-middle income countries.

Methods

We employed a sequential explanatory mixed-methods study design from 1st March 2019 to 31st March 2019. This design entails a quantitative approach followed by qualitative inquiry to explain the quantitative findings and to enhance the utility of findings for the concerned quarters [14]. We collected quantitative data by observing all meals that were provided to the inpatients for one month. For qualitative data, we interviewed the sources of errors- the respective staff in the food department of the hospital. The study tool used for this study could be accessed in the supporting document 1 titled “Study Tool”. The study was conducted in a private hospital, located in the capital of Pakistan.

The food preparation and its delivery to the patients involved different sections of the food department in the hospital. The relevant clinical staff recommended the diet of the inpatients in their clinical notes, based on patient’s need. The respective unit representative of the ward entered the diet in the computer system with patient details. The computer system then generated requests to the hospital food department for food preparation as per provided requirements.

There were two ways of tracking the errors in the system (Tables 1 & 2). When an error was noticed before consumption of the inaccurate meal (Table 1), the source of error was tracked and identified and the inaccurate diet was replaced with the correct one. If the error was noted after the consumption of inaccurate meal as a result of patient developing any adverse symptom, then it was checked with biochemical analysis to determine the dietary error. The list of biochemical analysis against all the advised diets are given in Table 2.

Table 1

Classification of dietary errors as per hospital’s criteria before the consumption of meals.

Advised Diet	Received Diet	Error Type
Regular	Soft/Full Liquid/ Semi Solid/Clear Liquid	Non-Critical Error
Soft	Full Liquid/ Semi Solid/Clear Liquid	Non-Critical Error
Semi Solid	Full Liquid/Clear Liquid	Non-Critical Error
Full Liquid	Clear Liquid	Non-Critical Error
Semi Solid	Regular/ Soft	Critical Error
Full Liquid	Regular/ Soft/ Semi Solid	Critical Error
Clear Liquid	Regular/Soft/Full Liquid/ Semi Solid	Critical Error
Allergic Patient	Received Allergens	Critical Error
Patient on intolerance Diet	Received any item that cause indigestion	Critical Error
NPO (Nil per Oral)	Received food item	Critical Error
Neutropenic Diet patient	Received raw/ uncooked item	Critical Error

Table 2

Classification of dietary errors as per biochemical reports after wrong meal consumption according to hospital’s criteria.

Recommended Patient Diet	TEST	Critical Values	Error
Diet Recommended by the American Diabetes Association	Blood Glucose Level	380mg/dl (Type II),500mg/dl (Type I)	Critical
Low salt	Blood Pressure	180/110mmHg	Non-Critical
No salt	Blood Pressure	210/110mmHg	Critical
Low Cholesterol	Lipid Profile	More than 210mg/dl	Non-Critical
No Cholesterol	Lipid Profile	>240mg/dl	Critical
Renal	Chem 7	6.5mEq/L	Critical

There were a total of five check points in the system and dietary errors could occur at any of these five points:

Diet entry:

Diet entry was the first point where patient’s diet was entered into the system by the Unit Representative (UR) and was the primary source of information provided to the dietary staff.

Diet card preparation:

A hard copy of detailed diet information was then forwarded to the dietitian who made diet cards based on the information provided.

Meal packing & tagging:

The kitchen received requests for food through the diet card. The kitchen personnel packed and tagged food according to the diet card, for example, renal diet, no salt or no chili diet, etc.

Tray preparation:

The tray was prepared according to the diet card and cross checked by the dietician who tallied the diet card with tag on the meal placed in the tray ready to be served to patient.

Meal provision:

The checked diet was then carried out in a heated trolley to the patient room. Before serving it to the patient, it was again cross checked by the floor staff with patient notes. If an error was detected, it was immediately reported to the food department for replacement. In case the error went unnoticed and the patient consumed the diet, the later vital statistics of the patient might indicate the incorrect diet.

Quantitative study

Census sampling technique was used for the collection of quantitative data over a period of one month (March 2019). The dietary record was collected on a daily basis for all the three meals per day per patient. Any dietary error arising on a particular day was marked for subsequent qualitative interview on the same day. The dietary information of patients admitted for at least 24 hours to any of the seven wards (medical, cardiac care unit, kidney transplant, gastroenterology, orthopedics, surgical, and neurology) of the hospital during the study period was included in the study. The dietary information from the comatose patients, and patients on nasogastric feed was excluded from the study. The reason being that these diets used to come from the hospital’s pharmacy and not the hospital’s kitchen, e.g. glucerna, and such diets were not a part of the hospital’s meal flow process.

We collected quantitative data by observing all meals provided to inpatients on a structured proforma, designed based on the variables that were either available and/or could be collected from the hospital system. The outcome variable was “diet error”, a binary variable with two possible outcomes: Critical / Non-Critical Errors. The definitions for critical/non-critical errors were based on the definitions provided by the hospital (Tables 1 & 2).

There were a total of five independent variables in this study, all categorical in nature. The accuracy of all the therapeutic meals were assessed at five main points in the food delivery system namely “point of error”: (1) Diet entry; (2) Diet card making; (3) Meal packing; (4) Tray preparation; and (5) Meal provision. The “responsible staff” included the unit representative, dietitian, cook, and service aide. The “Day of the Week” was a binary variable, defined as ‘Weekday’ and ‘Weekend’. The “Meal Type” included breakfast, lunch, and dinner. The “Ward” variable was composed of five levels: renal, cardiac, gastroenterology, orthopedics, and surgical wards.

All the quantitative variables were categorical in nature. The row percentages were calculated for all the independent variables against the outcome variable. We calculated frequencies and percentages for all the critical and non-critical errors using SPSS version 25 [15]. The Fisher’s exact test based p-values were also reported to find out any association between the independent variables and the outcome variable.

Qualitative study

The qualitative data were collected through in-depth interviews (IDIs). We employed purposive sampling technique following the concept of saturation. First, we detected the point of error and then the person responsible for error was approached. We explained the purpose of the interview/research and subsequently obtained oral consent for the interview to seek the potential causes and reasons of the dietary errors. For the face-to-face IDIs, a semi-structured interview guide was developed, based on the consensus of the authors and feedback from a qualitative research expert (apart from the one who’s leading the qualitative part of the study). A total of three questions were asked from all the participants, with little differences in probes depending upon the point of error. Each interview lasted for up to 30 minutes. The IDIs were conducted in the local language by two Masters’ students trained in qualitative research. Interviews were audio recorded, transcribed verbatim, and translated into English language. The Data were analyzed using a combined deductive-inductive thematic analysis approach [16]. The IDIs were transcribed by two researchers under the supervision of a senior qualitative researcher followed by debriefing sessions including cross-checking between moderator and note-taker, discussion on notes, and comparing them with audio recordings. Both the researchers thoroughly read the transcripts, to get familiarize with the data and to furnish the subsequent rounds of coding. Codes with similar concepts were grouped into explicit themes.

Ethical consideration

The ethical permission to conduct this study was granted by the Advance Studies & Review Board of the Khyber Medical University, Pakistan (No. DIR/KMU-AS&RB/IE/000966 dated 17th January 2020). The names and exact ages of the interviewed participants were masked in this study to ensure their confidentiality. The secondary data obtained was de-identified to ensure that none of the patients’ personal details are exposed.

Results

Quantitative analysis

A total of 7041 meals were observed including breakfast, lunch, and dinner of all the in-patients during the study period. Of all the meals with dietary errors, 64.71% were critical and 35.29% were non-critical in nature (Table 3). Majority of the total dietary errors occurred during the diet card preparation (52.94%), by the dietitians (70.59%), during weekdays (82.35%), at breakfast time (47.06%), and in the cardiac care unit (47.06%).

Table 3

The percentage wise distribution of dietary errors (N = 7041).

Variables		Critical ErrorsN (%)	Non-Critical ErrorsN (%)	Total ErrorsN (%)	p-value*
Overall		11 (64.7)	6 (35.3)	17 (0.24)
Point of Error	Diet Card Preparation	7 (77.8)	2 (22.2)	9 (52.9)	0.420
	Diet Entry	1 (33.3)	2 (66.7)	3 (17.7)
	Packing	0 (0)	1 (100)	1 (5.9)
	Tray line	2 (66.7)	1 (33.3)	3 (17.7)
	Meal Provision	1 (100)	0 (0)	1 (5.9)
Responsible Staff	Dietitian	9 (75.0)	3 (25.0)	12 (70.6)	0.245
	Unit Representative	1 (33.3)	2 (66.7)	3 (17.6)
	Cook	0 (0)	1 (100)	1 (5.9)
	Service Aide	1 (100)	0 (0)	1 (5.9)
Weekday	Yes	10 (71.4)	4 (28.6)	14 (82.3)	0.515
	No	1 (33.3)	2 (66.7)	3 (17.7)
Meal Type	Breakfast	5 (62.5)	3 (37.5)	8 (47.0)	1.00
	Lunch	4 (66.7)	2 (33.3)	6 (35.3)
	Dinner	2 (66.7)	1 (33.3)	3 (17.7)
Ward	Renal Transplant	2 (66.7)	1 (33.3)	3 (17.7)	0.037
	Cardiac Care	7 (87.5)	1 (12.5)	8 (47.1)
	Gastroenterology	1 (50.0)	1 (50.0)	2 (11.8)
	Orthopedics	0 (0)	3 (100)	3 (17.7)
	Surgical	0 (0)	1 (100)	1 (5.9)

Fisher exact test.

In Table 3, we observed that majority of the critical errors occurred during tray preparations (66.67%), meal provision (100%), diet card preparations (77.78%), by the dietitians (75.00%), service aides (100%), in all the meal types (~66%), among renal transplant patients (66.67%) and patients admitted in the cardiac care unit (87.50%). Among all the variables, only ward was found to be statistically significant.

Qualitative analysis

To find out the reasons of the dietary errors, we interviewed a total of 11 staff members responsible for dietary errors. The saturation in responses was observed in 10 interviews and was confirmed in one more interview. Some of the staff in the food department attributed the dietary errors to the increased workload while others could not concentrate on work due to various reasons. The themes that emerged from the analysis of the interviews are as follow:

Theme 1: Lack of back-up/accessory staff

The participants stated that hospital had limited number of employees in the food department and did not have a backup staff to replace any staff member on leave. One of the employees attributed the reason of dietary errors to the inability to handle increased demand load due to increased admissions. The food staff responsible for the diet error said;

“The patient load was too high for me to handle single-handedly”. (A male in his 20’s)

Similarly, a food staff came back after a long leave and could not handle patient load on the first few days;

“I was feeling tired as the patient load was too much. I could not concentrate after a long break”. (A male in his 20’s)

The lack of concentration, in some instances, was attributed to increased workload by the participants especially in cases where rare situations were encountered which resulted in critical errors. Rare situations were reported as food allergies of some patients or presence of two patients with exact same names but different rooms.

“I didn’t notice the allergy note as it was not prominent. There are so many patients’ diet to handle, so it went unnoticed”. (A female in her 20’s)

“The patient name was same and I didn’t pay attention to different room numbers. That day there were lot of food trays for delivery to patients. I should have checked the names and room numbers before serving anything to patients”. (A male in his 40’s)

According to participants, burnout due to working overtime to compensate for absent staff led to increased chances of errors. One of the food staff mentioned that;

“Sometimes we need to perform extra shift to cover for the staff on leave, this becomes burden and tiresome as the working hours become too lengthy”. (A male in his 20’s)

Another explicitly added;

“The management does not have a backup staff to cover for staff on leave that may get absent for any reason including getting sick”. (A male in his 30’s)

Theme 2: Employees’ personal and domestic issues

Another theme that emerged was the employees’ personal and domestic issues because of which they were unable to concentrate at work. Some of the employees attributed the reasons for dietary error to distributed concentration at work as a result of incidents at home. For instance, one of the staff mentioned;

“I was stressed as my spouse got injured in a road traffic accident, I needed a leave but could not get it, and therefore, I could not focus at work”. (A female in her 20’s)

Another expressed a job related pressure from home,

“My spouse wants me to leave the job and be at home”. (A female in her 20’s)

Another participant had an exchange of words at home as a result of which the staff was depressed;

“I had an argument with mother-in-law just few minutes before leaving home for duty. This made me depressed and I could not pay attention at work”. (A female in her 20’s)

Similarly, one of the food staff mentioned being unable to get leave due to illness as a reason for dietary errors;

“I didn’t sleep well just because I was not feeling well, so I was disturbed during my duty or you can say I was absent minded”. (A female in her 20’s)

Discussion

Nutrition therapy is often used in conjunction with the medical treatment to support and optimize the overall treatment outcome of the hospitalized patients [17]. The delivery of correct therapeutic diet is of paramount importance, in this regard. The prevalence of critical dietary errors accounted for majority of the dietary errors in our study. This result is consistent with other observational studies where the proportion of critical errors was the highest [6,8]. The majority of dietary errors took place during the diet card preparation followed by diet entry into the computerized system and the tray line. These findings are comparable to a study conducted in Thailand, which also related majority of the dietary errors to diet card preparation in the diet flow process [18]. The diet entry and diet card preparation processes are crucial being the initial steps in the diet flow process. It is imperative that these steps remain error free to prevent the error carried all the way to the patient. The main reasons of dietary errors were the lack of back up staff and the employees’ personal and domestic issues in this study.

The dietitians’ had two tasks at hand: to prepare diet cards and to check the diets with prepared diet cards during the tray preparation. In this study, about 70% of errors were attributed to the dietitians. This result is congruent to the Australian study where dietitians made up for majority of dietary errors [6]. Manual diet card preparation is not only cumbersome but also increases chance of error in case of increased workload. The human error can be prevented by getting the diet cards printed via computer systems or through automation as soon as the unit representative of the ward inputs the diet information into the computerized system [19]. Previous studies reported a significant reduction in dietary errors after introduction of automated diet cards’ preparation in hospital settings [6,8,20]. To have error free diet cards, it is imperative to have error free diet entry into the computerized system by the unit representative. The error free diet entry in the system could be ensured by double entry computerized systems as evident from research [21]. Alternatively, a tablet or phone based e-application could be developed, with a digital checklist diet form, linked to the patient’s electronic record system to prevent dietary errors [19]. Any diet entry that conflicts with the medical condition of the patient would generate an error upon incorrect diet selection. This system may have upfront cost but in the long run, would save expenses related to diet replacements, time, cooks’ labor, and medical expenses in case of inaccurate diet consumption. It is noteworthy that none of the dietary errors were attributed to the floor staff. This may indicate that a visual check of the diet with patient notes is a fruitful process of detecting dietary errors.

The reduction of in-patient dietary errors is of highest priority to improve the quality of patient care and treatment outcome. Humans are emotional beings [22] and any factor associated with their emotions may affect their work performance [23]. The common reasons for the errors were related to human capacity and human needs, e.g. increased workload, personal and domestic issues, limited capacity to manage patient load, and overwork burn out. There was less probability that someone would be available at home over the weekdays to take care of emergency issues, if one arises like narrated by the participants in this study. Similarly, start of the day may not be good if the employee’s concentration is not over the designated tasks [24,25]. It has been documented that occupational stress contributes to organizational inefficiencies especially in healthcare organizations where being in the right mind matters the most [26]. This warrants a need of stress management strategies and policies to be introduced in hospital for the staff to be fully available and efficient.

The private for-profit hospitals in low middle-income countries, like Pakistan, work on limited resources to maximize profits. In such countries, technology is expensive as compared to human resource. The findings of this study suggest that human errors could be minimized by adapting organizational behavior skills. For example, integrating empathy with the human resource management to improve employee job satisfaction. To do this, there should be a manageable workload on the employee. On-job training should be provided for capacity development of the food staff, and availability of back-up staff at all times to cater for increased patient load or replacement for staff on leave, so as not to compromise on quality and safety to in-patients.

Limitations

The findings of this study come with a limitation on generalizability as the study was conducted in one hospital. However, this was the only hospital in the country that had implemented international standards and provided therapeutic dietary meals to in-patients as a part of treatment regimen. The study derives its strength from the large number of observations. Additional strength is the qualitative component of the study which explored actual causes of dietary errors in the meal flow process. This is a firm strength of the study as qualitative components have not been explored in any of the earlier studies. Another limitation of the study was the use of the questionnaire to guide the student researcher on the collection of secondary data from the hospital records on a daily basis. The purpose was to prevent the student researcher from deviation from collecting data not related to the research objectives. This prevented us to apply Cronbach’s alpha to test the questionnaire’s reliability as neither did it contain any latent constructs or likert scale, nor did we carry out a field survey.

Recommendations

Based on the findings of this study, it is suggested that human errors could be minimized by adapting organizational behavior skills. For example, integrating empathy with the human resource management to improve employee job satisfaction. To do this, there should be a manageable workload on the employee. On-job training should be provided for capacity development of the food staff, and availability of back-up staff at all times to cater for increased patient load or replacement for staff on leave, so as not to compromise on quality and safety to in-patients.

Conclusion

In this study, critical dietary errors made up the majority of dietary errors in the hospital food department. Human factors were found to be the primary causes of these errors. It is proposed that the hospital may ensure and adhere to the principles of organizational behavior for contented employees that may result in error-free therapeutic food services to the patients. This may enhance patient safety, patient satisfaction, and patient well-being for better clinical outcomes.

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Reviewer #1: Check the grammar in the following sentence:

106 1) Diet entry

107 Diet entry was the first point where patient’s diet was entered the system by the Unit

108 Representative (UR) and was the primary source of information provided to the dietary

109 staf

In the Abstract it is stated that you employed SPSS v 20.

165 All the quantitative variables were categorical in nature. The row percentages were calculated

166 for all the independent variables against the outcome variable. We calculated frequencies and

167 percentages for all the critical and non-critical errors using SPSS version 25 (13).

Which version was rightly used.

Reviewer #2: There is no comment. I think both your method and your discussion have technical problem. Also your manuscript is not fit to this journal. I believe it would be great if you submit it to a journal which completely fit to your study.

Reviewer #3: In general, the article has been edited correctly, but some parts of the article need to be changed

Due to the non-native language of the article writing, my judgment about writing English may not be correct, but regarding other parts of the article, I expressed my views scientifically as a PhD student.

Reviewer #4: PONE-D-21-39046

Re: “The importance of human factors in therapeutic dietary errors of a hospital: A mixed methods study”

Thank you for asking me to review this manuscript. I have the following Comments:

Abstract: It should be rewritten in a structure format as per PLOS journal guidelines.

Introduction:

The authors quoted 11 references under introduction with only three short paragraphs. The introduction will benefit from details explanation related to the objectives of this study. Start with the definition of dietary errors and its examples.

Consider replacing “err” on line 71 by “error”.

Methods:

This section requires major revision.

The study tool used for this study on line 87-88, should be referenced or accessed through a link.

The validity of questionnaire and their Cronbach’s alpha and reliability scores should be reported after data collection.

Explain in more details’ inclusion and exclusion criteria of the study.

How were the data extracted? What were the sampling technique? What was the sampling equation to calculate sample size? How did the authors come up with 7041?

Explain in detail the independents variables?

Qualitative study:

The one conducting interview should have experience in qualitative research.

Experts in qualitative research should supervised data collection and hold feedback sessions shortly after the interview.

All interviews should be recorded and transcribed in full to verify the accuracy of responses.

Two members of the research team independently should analyze the transcribed responses and read them on multiple times to familiarize self with the contents and categorize it in a meaningful way.

All these points should be explained and incorporated under the design of qualitative study.

Quantitative study:

It should be explained in details and the collected data should be reported. Authors should do statistical analysis for quantitative data.

The authors stated on lines 144-145 that “The dietary information from the comatose patients, and patients on nasogastric feed were excluded from the study” Why? No patients interview was carried out in this study.

What was the definition of dietary errors in this study?

Table 1 and 2 should be moved under results.

What was ADA in Table 2 stand for?

Ethical consideration: needs to be under subheading after methods. There were issues with confidentiality and power imbalance with the recruitment process and I was unsure what the recruitment process was?

Results: Should be rewritten once the methods revised.

Statistical analysis should be done and report p-values. Furthermore, relationship between dependent and independent variables should be done from statistical analysis point of view.

Explain in details the personal and familial issues of the participants in relation to dietary errors.

Conclusion: It should be re-written with a major focus on the main results of the study. In addition, one statement of recommendation based on the findings of the study should be mentioned under conclusion. The statement about deaths in this study (lines 315-316), should be deleted as this was not investigated in this study.

Limitations of the study: should explain in details and logical ways. Personal, recall, misinterpretation biases and Hawthorne effect were possibilities in this study

References: The manuscript presents several references which were outdated, and some were irrelevant. The references should be revised, updated, and only used if it were relevant to the study. It also should follow the guidelines of the journal.

**********

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Reviewer #1: No

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Reviewer #3: Yes: Samira Raoofi (PhD student)

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Submitted filename: PONE-D-21-39046.pdf

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Submitted filename: PLOS ONE paper review 8.docx

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21 May 2022

May 21, 2022

Yong-Hong Kuo

Academic Editor, PLOS ONE

Subject: Response to Reviewers’ Comments

Dear Hon. Yong-Hong Kuo,

We thank the reviewers for taking out precious time to provide valuable comments for improving the manuscript. The comment serves to shape the manuscript to its perfection. Thank you for the constructive feedback on our manuscript, which we have carefully incorporated in the revised manuscript.

Please find responses to each comment below.

Thank you very much.

Response to Reviewer # 1:

Comment 1: Reviewer #1: Check the grammar in the following sentence:

106 1) Diet entry

107 Diet entry was the first point where patient’s diet was entered the system by the Unit

108 Representative (UR) and was the primary source of information provided to the dietary

109 staf

Response: We apologize for the inconvenience. The grammatical error has been rectified as per the reviewer’s suggestion. Thank you very much for noticing it.

Comment 2: In the Abstract it is stated that you employed SPSS v 20.

165 All the quantitative variables were categorical in nature. The row percentages were calculated

166 for all the independent variables against the outcome variable. We calculated frequencies and

167 percentages for all the critical and non-critical errors using SPSS version 25 (13).

Which version was rightly used?

Response: Thank you for noticing it. This happened as a result of the update of the software from thesis writing to the manuscript. This has been corrected now at both the places.

Response to Reviewer # 2:

Comment: There is no comment. I think both your method and your discussion have technical problem. Also your manuscript is not fit to this journal. I believe it would be great if you submit it to a journal which completely fit to your study.

Response: Thank you very much for taking time to review our manuscript. We looked at the journal information and scope of the journal before submitting the manuscript. In our view, our manuscript is pertinent and aligns with the aims and scope of the Plos One journal. Thank you once again.

Response to Reviewer # 3:

In general, the article has been edited correctly, but some parts of the article need to be changed.

Due to the non-native language of the article writing, my judgment about writing English may not be correct, but regarding other parts of the article, I expressed my views scientifically as a PhD student.

Response: We thank you for taking out the time to review our manuscript in spite that English is not your native language. Your review regarding our manuscript as a PhD student is much appreciated.

We believe that you are the reviewer who provided comments in the PDF document. In the light of this assumption, please find responses to your comments below.

Comment 1: It is better to compile a more concise abstract.

Response: The abstract followed journal guidelines and was tacitly limited to 249 words. On your recommendation, we have modified it and tried our best to keep it succinctly concise to give a brief flavor of all done in a nut shell. Thank you.

Comment 2: Table findings are not clear to contacts.

Response: The tables 1 and 2 are not results, rather these are the classification tables provided by the hospital to classify the dietary errors. Table 1 is about those dietary errors that could be noticed with the naked eye. Table 2 is about those errors that could not be noticed with a naked eye. However, patient’s development of symptoms later, as a result of consumption of inaccurate diet, is verified through a biochemical analysis as laid out in Table 2 against each advised diet to determine the inaccuracy in diet provision. The text associated with the tables have been rephrased to remove ambiguity. Thank you.

Comment 3: Regarding quantitative studies, the steps of the study should be mentioned exactly as mentioned in the qualitative studies.

Response: Thank you for your great comment. We have now accumulated all the steps of Quantitative methods under the heading of “Quantitative Study”. Similarly we have accumulated all the scattered information on qualitative methods under the heading of “Qualitative Study”.

Comment 4: Regarding the qualitative method, it is better to explain it as follows:

Qualitative study

How is the interview guide developed?

What resources have been used to compile the guide?

Response:

The topic guide was developed by the researchers keeping in view the objective of study (searching for reasons of errors), with further feedback from a qualitative research expert. As this was a much focused objective, we didn’t use any other resources to develop the topic guide. This is now explained on page 9, line #195-199. Thank you.

The information of the research community should be mentioned accurately.

Response:

Your point is well taken. We have now mentioned (page 9 line# 202-207) the details of the researcher who conducted the interviews. Thank you.

What type of sampling was used in selecting the statistical population?

Response:

We used purposive sampling technique, the most frequently used approach in qualitative research, mentioned on page 9, line #191-192. Thank you.

How were the interviews conducted?

Response:

This is mentioned on page 9, line #191-207. Thank you.

The results should be categorized as main and secondary themes and final codes in a table.

Response:

Thank you for bringing this up. The qualitative results are now presented under two emerging themes (page 11, line #238 and page 12, line #275). We didn’t opt for a table of qualitative results for two reasons. (1) There are already three tables for quantitative section of the study and (2) the reasons for dietary errors are reasonably explicit under the two themes. Thank you.

What has been the reliability and validity of your qualitative study?

Response:

Among the aspects of Credibility (validity) and Dependability (reliability) of a qualitative study, some features are touched upon and can be seen in methods and results section. These included: debriefing sessions, use of probes, informed consent, use of representative quotes, overall clearly mentioned methods. The previously scattered information of qualitative section in methods has now been gathered under one title “qualitative study” on page 9. Thank you.

In the end, how was the data analysis and with what software?

Response:

We used deductive-inductive thematic analysis approach, mentioned on page 9, line #202 with due citation. Moreover, we did manual coding without using any software. Thank you.

Comment 5: It is better to establish correlations between the contents in the findings.

Response: All the data that was collected through the secondary sources is categorical in nature. The correlations, therefore, do not apply. Moreover, the correlations are not applicable as the objective was not find any statistical association. Thank you.

Comment 6: The results should be categorized according to the main themes and its descriptions.

And at the end, write the key sentences of the interviews.

Response: Thank you for pointing this out. The results are now organized to the main themes, its description, and the verbatims.

Comment 7: In any case, the discussion has been done correctly, but it is better to compare with more studies, and given that the study includes two categories of quantitative and qualitative results, the number of studies compared is not enough for discussion.

Response: The reviewer is right that the main findings of the study should be compared with further studies. However, it is unfortunate that we could find only two studies related to the quantitative findings of the study. The research literature regarding the therapeutic diets is extremely scarce, else we would have added further studies.

However, studies related to the findings of the qualitative portion of the manuscript have been added to support the claims. Thank you.

Comment 8: The conclusion section should be revised and in this section the findings should not be repeated, but executive strategies should be developed to improve the current situation and suggestions for future research should be stated along with study limitations.

Response: The conclusion section has been revised a bit. The conclusion section reflects the synthesis of key points and way forward. The limitations are usually a part of the discussion section. The limitations could be found in the last paragraph of the discussion section. A separate section on recommendations is now added before conclusions. Thank you.

Response to Reviewer # 4:

Comment 1:

Abstract: It should be rewritten in a structure format as per PLOS journal guidelines.

Response:

The abstract follows guidelines given by the PLOS One at:

https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf

Thank you.

Comment 2:

Introduction:

The authors quoted 11 references under introduction with only three short paragraphs. The introduction will benefit from details explanation related to the objectives of this study. Start with the definition of dietary errors and its examples.

Consider replacing “err” on line 71 by “error”.

Response:

There hasn’t been much research on therapeutic diets provided in the hospital systems. This is why there isn’t much material available on it. As per the reviewer’s suggestion, we have lengthen the introduction section, keeping in view that it should not deviate from the objectives of the study. The definition of dietary errors and its examples have also been provided now.

“To err is human” is considered a standard phrase these days and used by WHO as such as well. Please follow the following link: https://www.who.int/news-room/fact-sheets/detail/patient-safety Heading “Why does patient harm occur?” first line of the second paragraph.

If the reviewer wants us to replace it with the term “error”, we would be still happy to do it. Thank you.

Comment 3:

Methods:

This section requires major revision.

The study tool used for this study on line 87-88, should be referenced or accessed through a link.

Response:

We apologize for the inconvenience caused at this stage. However, the study tool cannot be hyperlinked at this stage, as per journal requirements. It will be accessed through a link when and if it gets published. In current form, it could be accessed at the very end of the manuscript where the page title states “Supporting Document 1: Study Tool” via link auto-generated (at the end of the document) by the journal during the submission stage. Within the manuscript, it has been referenced to “supporting document 1 title Study Tool” on page 5 line # 105. Thank you.

Comment 4:

The validity of questionnaire and their Cronbach’s alpha and reliability scores should be reported after data collection.

Response:

The quantitative portion of the study collected information from secondary data, extracted from the hospital records. The questionnaire was not meant to conduct a survey in the field. The statements have been amended in the manuscript to reflect better on the process of quantitative data collection. The validity and the associated measures, therefore, do not apply for both the quantitative and qualitative components of the study. Thank you.

Comment 5:

Explain in more details’ inclusion and exclusion criteria of the study.

Response:

All the diets provided within the hospital system in one month were included in the study. Only diets to those on nasogastric tube and comatose patients were excluded as these diets used to come from the hospital’s pharmacy and not the hospital’s kitchen, e.g. glucerna, and such diets were not a part of the hospital’s meal flow process. Both the inclusion and exclusion criteria have been expanded as per the reviewer’s comment. Thank you.

Comment 6:

How were the data extracted? What were the sampling technique? What was the sampling equation to calculate sample size? How did the authors come up with 7041?

Response:

The secondary quantitative data were extracted from the hospital records on a daily basis. When an error was encountered, it was notified to the hospital’s computer system, the source of error was traced and the relevant personnel was/were interviewed. All the diets within one month of the study period were taken into account. All these diets, three per day per patient, accounted to 7041. This is why we deployed census sampling technique, also mentioned in the text on page 8 line 160. Thank you.

Comment 7:

Explain in detail the independents variables?

Response:

The details on the independent variables are available on page 8 lines 177-184. Thank you.

Comment 8:

Qualitative study:

The one conducting interview should have experience in qualitative research.

Response:

The interviews were conducted by a student of Masters in Public Health, who was trained in qualitative research, and this is now mentioned on page 9, line 199-201. Thank you.

Comment 9:

Experts in qualitative research should supervised data collection and hold feedback sessions shortly after the interview.

All interviews should be recorded and transcribed in full to verify the accuracy of responses.

Two members of the research team independently should analyze the transcribed responses and read them on multiple times to familiarize self with the contents and categorize it in a meaningful way.

All these points should be explained and incorporated under the design of qualitative study.

Response:

Almost all of these comments were already there but probably due to scattered information of quantitative and qualitative sections in methods, this information didn’t seem explicit. We have now gathered all the qualitative study methods under one title “qualitative study” on page 9, satisfying all your comments. Thank you very much for your constructive comment.

Comment 10:

Quantitative study:

It should be explained in details and the collected data should be reported. Authors should do statistical analysis for quantitative data.

Response:

The statistical analyses were performed according to the objectives of the study. The percentages have been reported that best suit the objectives of this manuscript. Thank you.

Comment 11:

The authors stated on lines 144-145 that “The dietary information from the comatose patients, and patients on nasogastric feed were excluded from the study” Why? No patients interview was carried out in this study.

Response:

All the diets provided within the hospital system in one month were included in the study. Only diets to those on nasogastric tube and comatosed patients were excluded as these diets used to come from the hospital’s pharmacy and not the hospital’s kitchen, e.g. glucerna, and such diets were not a part of the hospital’s meal flow process. This explanation has now been added in the manuscript. Thank you.

Comment 12:

What was the definition of dietary errors in this study?

Response:

Thank you for pointing this out. The dietary errors were not explicitly mentioned in the introduction section. The tables 1 and 2 denote the dietary errors: the first column of each table denoting the diet that was recommended and the second column denoting the diet that was received in error. Now the introduction section contains the definition of dietary errors and its types. Please consult page 3 lines 64-65. Thank you.

Comment 13:

Table 1 and 2 should be moved under results.

Response:

The placement of tables follow the journal guidelines, i.e., “Tables should be included directly after the paragraph in which they are first cited.” (https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf)

Tables 1 and 2 are not the results but contain the detailed information on the dietary errors and its types. Thank you.

Comment 14:

What was ADA in Table 2 stand for?

Response:

Thank you for noticing it. ADA refers to the American Diabetes Association. This indicated the diabetic diet recommended by the American Diabetes Association for the diabetic patients. This acronym has been detailed in Table 2 now. Thank you.

Comment 15:

Ethical consideration: needs to be under subheading after methods. There were issues with confidentiality and power imbalance with the recruitment process and I was unsure what the recruitment process was?

Response:

The ethical consideration has been moved as a subheading after methods. The confidentiality statements have been added for both quantitative and qualitative components under the ethical consideration subheading.

The quantitative study was observational in nature and all the data was extracted on a daily basis over one month, therefore, the concept of statistical power does not apply here. Census sampling was used to collect all the data on a daily basis for one month. For the qualitative interviews, the sampling was purposive as only those personnel were interviewed who were reported for dietary error. Thank you.

Comment 16:

Results: Should be rewritten once the methods revised.

Response:

Subheadings have been added in the manuscript for clarity purposes. The results section has been modified to reflect further clarity. Thank you.

Comment 17:

Statistical analysis should be done and report p-values. Furthermore, relationship between dependent and independent variables should be done from statistical analysis point of view.

Response:

The most pertinent statistical analyses are the percentages in this study. As the objective of the study was neither to explore the associations nor the factors associated with the outcome variable nor to test a hypothesis, therefore, inferential statistics were not deployed, rather only descriptive statistics were reported. Another reason for reporting only percentages was to assess the prevalence of dietary errors. Losing one precious life due to dietary error is as serious as losing multiple lives. This is why the percentages mattered the most, in our opinion, here. Thank you.

Comment 18:

Explain in details the personal and familial issues of the participants in relation to dietary errors.

Response:

This is described in the results and discussion sections both. The results section has verbatims in the italicized text to give an idea on what was going on in the personal lives of the interviewed participants that effected their work at the hospital. This has been referenced with theories/published research papers. Thank you.

Comment 19:

Conclusion: It should be re-written with a major focus on the main results of the study. In addition, one statement of recommendation based on the findings of the study should be mentioned under conclusion. The statement about deaths in this study (lines 315-316), should be deleted as this was not investigated in this study.

Response:

The conclusion has been modified as per the reviewer’s suggestion. Thank you.

Comment 20:

Limitations of the study: should explain in details and logical ways. Personal, recall, misinterpretation biases and Hawthorne effect were possibilities in this study

Response:

Personal biases could have been there but this is a universal problem to all the qualitative studies. However, the personal bias was minimal in this study as the researchers verified some of the claims of the study through the hospital records, e.g. the leave application was submitted but not granted to one/some of the participants.

Recall bias was also minimized as the researchers interviewed the participants on the same day of the error notified.

Misinterpretation bias was also minimized. The jargon was not used, rather the interviews utilized local language of the study tool.

There could have been Hawthorne Effect if the study participants were observed directly. However, none of the participants at each level of the food preparation were observed directly. Only when a dietary error was reported, the respective participant was contacted with their permission to explore the causes of error.

Thank you for asking for explanation on these.

Comment 21:

References: The manuscript presents several references which were outdated, and some were irrelevant. The references should be revised, updated, and only used if it were relevant to the study. It also should follow the guidelines of the journal.

Response:

The research topic has not been studied much. The references found in the subject area are from year 2001 and onwards and these are the only references that are available to this research topic. The references have been updated (where applicable). Kindly note that the references have added to justify/support the statements/claims made in the study, these are, therefore, need to be cited. Thank you.

Submitted filename: Response to Reviewers.docx

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30 May 2022

5 Jul 2022

July 05, 2022

Yong-Hong Kuo

Academic Editor, PLOS ONE

Subject: Response to Reviewers’ Comments

Honorable Yong-Hong Kuo,

We thank the reviewers for taking out precious time to review our manuscript. The comments serve to shape the manuscript to its perfection. Thank you for the constructive feedback on our manuscript, which we have carefully incorporated in the revised manuscript.

Please find responses to each comment below.

Thank you very much.

Response to Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Response: To our knowledge, none of the papers cited have been retracted. We double checked all the articles for retraction. However, the reference number 4 had an old link that was changed after the submission of the manuscript by the publishers. The link has been updated now for the paper referenced as number 4. Thank you for noticing this.

P.S: The referenced article 4 does not depict tracked changes in the “references” section for some reasons.

Response to Reviewer # 4:

Thank you very much for allowing me to review this manuscript for the second time.

Most of the required corrections have been made and the manuscript had been improved scientifically. The authors responded to majority of my comments and provided valuable information which are important for the readers. I further have the followings minor comments:

1. The validity of questionnaire and their Cronbach’s alpha and reliability scores should be reported after data collection. This was communicated to the authors, however they felt that this do not apply for both quantitative and qualitative components of the study as the questionnaire was not meant to conduct a survey in the field. Regardless, as long as the questionnaire was used in this study, its validity and their Cronbach’s alpha and reliability scores should be calculated.

Response: The questionnaire was formed to assist the student researcher to extract data from secondary sources (hospital records) so that only that information is gathered that is related to the research question and to prevent any deviation or distraction for the student researcher. It should be noted that neither latent variables were constructed nor any field survey was conducted in our study. Also, the questionnaire did not use any Likert scale. The honorable reviewer remarks that as the word "questionnaire" has been used, therefore, Cronbach's alpha should be applied regardless. We tried to get more information on this topic by looking at the literature and realized this doesn't apply to our research. Please follow the articles below that justify our claim:

1. Making sense of Cronbach's alpha

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4205511/

2. The Use of Cronbach’s Alpha When Developing and Reporting Research Instruments in Science Education

https://link.springer.com/article/10.1007/s11165-016-9602-2

3. Cronbach Alpha Coefficient

https://www.sciencedirect.com/topics/nursing-and-health-professions/cronbach-alpha-coefficient

4. Using and Interpreting Cronbach’s Alpha

https://data.library.virginia.edu/using-and-interpreting-cronbachs-alpha/

5. Cronbach’s Alpha: Definition, Interpretation, SPSS

https://www.statisticshowto.com/probability-and-statistics/statistics-definitions/cronbachs-alpha-spss/

6. Cronbach’s Alpha and Semantic Overlap Between Items: A Proposed Correction and Tests of Significance

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8867700/

If the concern is over the word “questionnaire”, we can rephrase the manuscript that the data were drawn from secondary sources as an alternative, skipping the term questionnaire at all. We wrote the manuscript in complete honesty. This is why we explained everything in detail in addition to allow for reproducibility of the research. However, to address the concern of the reviewer in this scenario, we have added the issue of Cronbach’s alpha in the limitations section of our manuscript, which could be found at page 17 lines 365-370.

2. Authors should do statistical analysis for quantitative data. Furthermore, relationship between dependent and independent variables should be done from statistical analysis point of view. The authors responded to this issue as the objective of the study was neither to explore the associations nor the factors associated with the outcome variable nor to test a hypothesis, therefore, inferential statistics were not deployed, rather only descriptive statistics were reported. I do not think this is the case as further statistical analysis will help to achieve the objectives of the study and use independent variables in this study to predict the value of dependent variable (dietary errors). I think such statistical analysis will strengthen the findings of this study.

Response: Majority of the times, inferential statistics are used when one is testing a hypothesis or wants to explore the associations. Our study did not have any such objectives. We used only descriptive statistics because a critical error in the hospital setting could hamper a patient's life, regardless if it's statistically significant or not. In our expertise, the use of inferential statistics doesn't justify in this manuscript as the factors associated with the errors have been explored in the qualitative component of the manuscript.

However, in the light of making the manuscript a bit more scientific as per reviewer’s comment, we applied the inferential statistics as it would not jeopardize the study objectives. The Fisher-exact based p-values have been reported to the Table 3 on pages 10-11. A bit of the description has also been added to the text on page 9, lines 187-189 and page 11, lines 231-232. Thank you.

Submitted filename: Response to Reviewers.docx

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15 Aug 2022

The importance of human factors in therapeutic dietary errors of a hospital: A mixed-methods study

PONE-D-21-39046R2

Dear Dr. Sadiq,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

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Kind regards,

Yong-Hong Kuo

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

All the referees' concerns have been addressed. I recommend Accept.

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

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Reviewer #2: All comments have been addressed

**********

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Reviewer #2: Yes

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Reviewer #2: Yes

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Reviewer #2: Yes

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Reviewer #2: Yes

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Reviewer #2: No

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17 Aug 2022

PONE-D-21-39046R2

The importance of human factors in therapeutic dietary errors of a hospital: A mixed-methods study

Dear Dr. Sadiq:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

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