The impact of clinical pharmacist-led health education on the disease course of non-alcoholic fatty liver disease patients: an interventional study

Nehal Abou Seada; Manal El Hamamsy; Sarah Shaheen; Reda Elwakil; Alaa Barakat; Azza El‐Sayed Mansy

doi:10.12688/f1000research.77415.1

Home Browse The impact of clinical pharmacist-led health education on the disease...

ALL Metrics

-

Views

-

Downloads

Get PDF

Get XML

Export

▬

✚

Research Article

The impact of clinical pharmacist-led health education on the disease course of non-alcoholic fatty liver disease patients: an interventional study

[version 1; peer review: 3 approved with reservations]

Nehal Abou Seada ¹, Manal El Hamamsy², Sarah Shaheen², Reda Elwakil³, Alaa Barakat⁴, Azza El‐Sayed Mansy⁵

Nehal Abou Seada ¹, Manal El Hamamsy², [...] Sarah Shaheen², Reda Elwakil³, Alaa Barakat⁴, Azza El‐Sayed Mansy⁵

PUBLISHED 24 Feb 2022

Author details Author details

¹ Clinical Pharmacy Unit, Ain Shams University Specialized Hospital, Cairo, Egypt
² Clinical Pharmacy Department, Ain Shams University, Cairo, Egypt
³ Department of Tropical Medicine, Faculty of Medicine Ain Shams University, Cairo, Egypt
⁴ Department of Biochemistry and Biotechnology, Heliopolis University, Cairo, Egypt
⁵ Department of Clinical Pharmacy, Faculty of Pharmacy Al Menoufiya, University, Al Menoufiya, Egypt

Nehal Abou Seada
Roles: Conceptualization, Formal Analysis, Investigation, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Manal El Hamamsy
Roles: Conceptualization, Project Administration, Supervision, Writing – Review & Editing

Sarah Shaheen
Roles: Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing

Reda Elwakil
Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing

Alaa Barakat
Roles: Conceptualization, Resources, Supervision

Azza El‐Sayed Mansy
Roles: Conceptualization, Data Curation, Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Global Public Health gateway.

Abstract

Background: A multitude of health care professionals, including pharmacists, are needed in managing a complex and silent disease like non-alcoholic fatty liver disease (NAFLD) associated with metabolic syndrome (MetS). These health care professionals can increase patients’ health awareness regarding the prevention and the management of the disease. The current study aimed to evaluate the impact of clinical pharmacist education, counseling and follow up on the management of NAFLD with MetS.
Methods: This study recruited 102 patients with NAFLD and MetS. Participants received regular health education sessions concerning the disease and recommended lifestyle (diet and exercise) and were followed by clinical pharmacist for 6 months. At the end of the study, participants were divided into two groups; those compliant with education and follow up session (compliant group; n=61); and those attending > 60% but not completing whole sessions (non-compliant group; n=41). Anthropometric measures, liver function, lipid profile, homeostasis model of assessment-insulin resistance (HOMA-IR), biochemical NAFLD score, radiological liver steatosis and fibrosis grade changes were recorded at baseline and endpoint.
Results: The compliant group showed a more significant decrease in weight (p=0.003), low density lipoprotein (LDL) (p=0.009), and very LDL (p<0.001), and a more significant increase in high density lipoprotein (HDL) (p=0.010) compared with the non-compliant group. Moreover, the compliant group showed a statistically significant higher number of patients achieving normalization of total cholesterol (p=0.002), HDL (p=0.004), waist circumference (p=0.004), improvement of body mass index category (p=0.008), liver steatosis grade (p=0.009), liver fibrosis grade (p<0.001), and absence of dyspeptic symptoms (p=0.0010) and hepatomegaly (p= 0.027) compared with the non-compliant group. Fasting blood glucose (p=0.209), fasting insulin (p=0.179), and HOMA-IR score (p=0.193) showed non-significant difference between both groups at endpoint.
Conclusion: The educational intervention of a clinical pharmacist showed significant positive impact on ameliorating metabolic syndrome parameters and achieving desired NAFLD therapeutic outcomes.

Keywords

NAFLD, clinical pharmacist, patient education, life style recommendations, metabolic comorbidities

Corresponding author: Nehal Abou Seada

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2022 Abou Seada N et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Abou Seada N, El Hamamsy M, Shaheen S et al. The impact of clinical pharmacist-led health education on the disease course of non-alcoholic fatty liver disease patients: an interventional study [version 1; peer review: 3 approved with reservations]. F1000Research 2022, 11:234 (https://doi.org/10.12688/f1000research.77415.1) First published: 24 Feb 2022, 11:234 (https://doi.org/10.12688/f1000research.77415.1) Latest published: 24 Feb 2022, 11:234 (https://doi.org/10.12688/f1000research.77415.1)

Background

The logistic and economic pressure on healthcare systems worldwide have encouraged the incorporation of pharmacists in disease state management services. This is mostly attributed to the fact that pharmacists are one of the most accessible and knowledgeable health care professionals when concerning disease and medication characteristics. Thus they can ensure optimization of acute and chronic patient care.¹ The pharmacist has a crucial role in managing many chronic conditions, including heart failure, asthma, chronic obstructive pulmonary disease, diabetes mellitus (DM), hypertension, dyslipidemia, overweight and obesity. Incorporating a pharmacist in the care of such diseases has led to the achievement of target therapeutic goals, prevention and management of drug related problems, and reduction of medication costs.²^–⁹

Non-alcoholic fatty liver disease (NAFLD) includes two pathologically distinct conditions; non-alcoholic fatty liver (NAFL), characterized by simple hepatic steatosis and absence of hepatocyte injury, and non-alcoholic steatohepatitis (NASH), associated with hepatocellular injury with or without fibrosis.¹⁰ NAFLD is a health condition with significant morbidity, mortality, and economic burden to the healthcare system.¹¹ In these patients, multiple metabolic comorbidities often exist, such as hypertension, type 2 DM, hyperlipidemia, and overweight or obesity. Complications of NAFLD include liver cell failure, hepatocellular carcinoma and the need for liver transplantation.¹² Thus, the goal is not only to treat the liver-specific disease but to manage comorbidities and prevent complications.¹³ The only FDA-approved anti-NAFLD measure is lifestyle recommendations, including dietary and exercise advice. Thus effective patient education and close follow up is needed. Pharmacists can play a significant role in supporting NAFLD patient education to achieve target anthropometric measures and improve hepatic fibrosis and steatosis.¹⁴

Pharmacists have the basic knowledge and clinical skills, including prioritization and individualization of therapeutic goals and professional communication abilities, necessary to perform such roles. Unfortunately, clinical pharmacists are struggle to implement their roles within a multidisciplinary team providing patient care in developing countries.¹⁵ To our knowledge, studies investigating the impact of pharmacists’ roles in the management of NAFLD are absent worldwide and most of the evidence evaluating the impact of health professional in managing metabolic morbidities focus on physicians and nurses.¹⁶ Moreover, evidence supporting pharmacist involvement in NAFLD or metabolic morbidities prevention or management are completely absent in Egyptian population.¹⁷ We previously reported the beneficial outcome of adjuvant phosphatidylcholine in Egyptians with NAFLD plus the cornerstone management modality of life style and exercise education conducted by a clinical pharmacist to all study participants.¹⁸ As an extension of the previous work, the aim of the current study was to evaluate the impact of a clinical pharmacist education, counseling and follow up in the management of Egyptian NAFLD patients with metabolic co-morbidities.

Methods

Study design and setting

This non-randomized interventional study was conducted in the out-patient clinics of the tropical medicine departments at Ain Shams University Hospitals and Ain Shams Specialized Hospital in Cairo, Egypt, between January 2016 and January 2019.

Study participants

Patients older than 18 year with a diagnosis of NAFLD (including NAFL and NASH) according to the EASL-EASD-EASO Clinical Practice Guidelines¹⁹ were included in the study. Recruitment was done through tropical medicine physician appointments for ultrasonography. Patients were excluded from the study if they have an evidence of other types of liver disease (alcoholic, autoimmune, carcinoma), have end stage liver disease, were pregnant or lactating, and had used a lipid lowering or weight loss medication in the last 6 months.

Sample size determination

Due to the reporting of multiple primary outcomes a number of least 100 patients for both arms together were considered sufficient to achieve an alpha error of 5% and a beta error of 1%. Patients who consented for any of investigations aim were included in statistical analysis to enhance the significance of results.

Since the approval was released on the basis of supporting lifestyle modifications as counseled and followed up a clinical pharmacist to all study participants,¹⁸ grouping for statistical analysis was done at the end of the study duration based on patients compliance to scheduled sessions and resulted in the existence of 61 and 41 participants in compliant and noncompliant group respectively.

Ethical concerns

The study protocol was approved by the institutional review board of Ain Shams University according to the declaration of Helsinki. The study was registered in ClinicalTrials.gov under the identifier NCT04411862. Participants were only recruited after they returned a signed informed consent form.

Study intervention

The interventing clinical pharmacist (the corresponding author) interviewed all eligible participants (n=102) to collect contact details (for follow up), histories, including medical, medication, family, and social histories. All eligible participants were then provided with regular (one every two weeks for six months) health education, counseling and follow up sessions as individualized appointments with the intervening clinical pharmacist in a private consultation room inside out-patient clinics area. The education sessions included an explanation of what NAFLD is and that it is reversible with lifestyle change, the expected complications of inappropriately managed disease and the recommended life-style modifications.³⁷ General advice included aerobic exercise (walking for 30 minutes daily, or > 3 km/day three times weekly) and restricting caloric intake to less than 30 kcal/kg/day while maintaining a balanced diet that included low levels of saturated and trans-fats to achieve gradual weight loss. The target weight loss was a 10% loss within 6 months to avoid rapid weight loss (> 1.6 kg/week) that could increase the progression of NAFLD. Self-regulation was encouraged through participants counselling about regular body weighing, using a smartphone app or internet websites, or even a dairy for counting daily calories, and use of pedometers or body activity trackers. Additionally, a WhatsApp group including all participants and the intervening clinical pharmacist was established. Replies to participant’s inquiries were provided through this group as well as through the interventing clinical pharmacist’s email (provided to patients) for providing individualized patient counseling. The clinical pharmacist also provided participants with a written scheduled appointments for sessions, and educative brochures describing the nature and complications of NAFLD and comorbidities such as diabetes, obesity, and metabolic syndrome, as well as individualized monthly dietary plans for all recruited patients. Participants were encouraged to provide a food and exercise log.²⁰

Participant recruitment, grouping, intervention and follow up are summarized in the CONSORT flow chart (Figure 1).

Figure 1. Study design flow diagram.

BMI: Body mass index; FBG: Fasting Blood Glucose; FBI: Fasting Blood Insulin; HOMA-IR: Homeostasis Model of Assessment-Insulin Resistance; NAFLD: Non Alcoholic Fatty Liver Disease.

At the end of the study

Participants were grouped according to their compliance to the follow up and education sessions: compliant group, those who attended all 12 sessions (n=61); and non-compliant group, those who attended more than 8 sessions but did not complete all 12 sessions (n=41).²¹ No participants attended less than 8 sessions.

Study outcomes

Study outcomes were measured at baseline and endpoint in both groups. The primary endpoint for NAFLD was the change of NAFLD radiological parameters measured by abdominal transient elastography, using FibroScan^® Expert 630 (Echosens, Paris, France) to measure liver fibrosis and steatosis. Liver fibrosis grades included: F0 referring to no fibrosis, F1 referring to portal fibrosis without septa, F2 referring to portal fibrosis with few septa, F3 referring to numerous septa without cirrhosis, and F4 referring to cirrhosis.²² Liver steatosis grades included: S0 referring to <5% steatosis, S1 referring to a 5-33% steatosis, S2 referring to a 33-66% steatosis, and S3 referring to >66% steatosis.²³

The primary endpoint for metabolic co-morbidities was the number of patients with MetS defined by the presence of any three out of the following five features: waist circumference in the horizontal plane midway between the lowest ribs and the iliac crest²⁴ ≥102 cm in men or ≥88 cm in women; triglycerides (TG) ≥150 mg/dL; high density lipoprotein-cholesterol (HDL) <40 mg/dL in men or <50 mg/dL in women; blood systolic pressure ≥130 or diastolic >85 mm Hg measured according to the standard technique using validated cuff-based automated devices in a properly configured setting²⁵ or on antihypertensive drug in patients with a history of hypertension; and fasting blood glucose (FBG) >100 mg/dL or on drug treatment for elevated glucose (including diabetics).²⁶ TG, HDL, and FBG were measured by enzymatic colorimetric method with the Olympus Corp. AU 600 autoanalyser using reagents from Olympus Corp. (Hamburg, Germany).

Secondary outcome measurements included anthropometric changes to body mass index (BMI, calculated as weight divided by squared height; weight and height were measured with a Health-ometer professional scale), waist and hip circumference, biochemical markers of NAFLD, and comorbidities such as liver functions (determined by colorimetric assay using kits obtained from Biomerieux Vitek, Inc Missouri USA), lipid profile, and fasting insulin (measured by chemiluminescent immunoassay method; Immulite 1000 System, DPC, Los Angeles, CA; 90045-5597) and blood glucose. Additionally, NAFLD fibrosis score (a combined biochemical and clinical score calculated using platelet count, serum aminotransferases and albumin, age, BMI, and diabetic status, calculated using NAFLD fibrosis score calculator) that estimate the probability of liver fibrosis,²³ and homeostasis model assessment—insulin resistance (HOMA-IR; a biochemical score calculated using serum fasting blood glucose and insulin) score that assess insulin resistance in non- diabetic patients²⁷ were estimated for each participant using the HOMA2 Calculator (University of Oxford, 2019). NAFLD fibrosis score categories includes: low cutoffs (<-1.455), predicting a fibrosis level of F0-F2; indeterminate cutoffs (-1.455 to 0.675); and high cutoffs (>0.675) predicting a fibrosis level of F3-F4.¹³ A HOMA-IR >3 indicates the presence of insulin resistance.²⁷

Statistical analysis

Recorded data were analyzed using the SPSS, version 20.0 (SPSS Inc., Chicago, Illinois, USA, RRID:SCR_002865). Data were explored for normality using the Kolmogorov-Smirnov test.²⁸ Quantitative data were expressed as mean± standard deviation if parametric and as median and interquartile ranges if non-parametric. Qualitative data were expressed as frequency and percentage. Independent-samples t-tests were used to compare two samples of quantitative parametric means. Post-hoc comparisons were conducted using the Bonferroni correction method. The chi-square test was used to compare qualitative parameters. The confidence interval was set to 95% and the margin of error accepted was set to 5%. So, the p-value was considered significant if <0.05 and highly significant if <0.001.

Results

The mean levels and comparisons of selected baseline demographics, weight and metabolic co-morbidities of studied groups are shown in Table 1. The study cohort (n=102) included 86 women and 16 men. There was no statistically significant difference between both groups regarding any of the compared demographics.

Table 1. Comparison of demographics and co-morbidities between study groups.

Parameter	Compliant group (n=61)	Non-compliant group (n=41)	Test coefficient	p-value*
Age (years); mean ± SD	51.77±7.72	51.22±6.74	t=0.371	0.711
Gender
Female; number (%)	49 (80.3%)	37 (90.2%)	x2=1.823	0.177
Male; number (%)	12 (19.7%)	4 (9.8%)
Weight (kg): mean ± SD	94.52±10.30	98.32±10.79	t=-1.793	0.076
Diabetics; number (%)	30 (49.2%)	16 (39.0%)	x2=1.021	0.312
Hypertensive; number (%)	24 (39.3%)	24 (58.5%)	x2=3.625	0.057
Use of hepatoprotectors**; number (%)	46(75.4%)	31(75.6%)	x2=0.204	0.651
Use of antioxidant	35(57.37%)	22(53.65%)	x2=0.1375	0.710

* p-value >0.05 is non-significant.

** Use essential phospholipids.

Anthropometric changes

The compliant group showed a statistically significant higher number of patients with normalized waist circumference (p=0.004, Figure 2³⁸) and an improved BMI category, as shown in Table 2. These results were accompanied by a decrease in participant weight in kg in both groups but this was more significant in the compliant group (p=0.003) and confirmed with the percent change of 11.66%±5.77 in compliant versus 8.39%±6.05 in non-compliant group; p=0.007).

Figure 2. End-point comparison of percentage of participants reaching normal levels of clinical parameters and scores between studied groups.

NAFLD; non-alcoholic fatty liver disease.

*Statistically significant difference p≤0.05 as compared to non-compliant.

Table 2. BMI categories changes in studied groups.

BMI categories*	Compliance Group (n=61)	Non Compliance Group (n=41)	x²	p-value**
*Baseline*
Overweight	5 (8.2%)	0 (0.0%)
Obese I	21 (34.4%)	9 (22.0%)	6.525	0.089
Obese II	25 (41.0%)	21 (51.2%)
Obese III	10 (16.4%)	11 (26.8%)
*Endpoint*
Normal	4 (6.6%)	0 (0.0%)	13.688	0.008*
Overweight	15 (24.6%)	4 (9.8%)
Obese I	32 (52.5%)	18 (43.9%)
Obese II	9 (14.8%)	17 (41.5%)
Obese III	1 (1.6%)	2 (4.9%)

* p-value >0.05 is non-significant.

** Normal weight (18.5 – 24.9 kg/m²), overweight (25-29.9 kg/m²), obese I (>30 kg/m²), obese II (35-39.9 kg/m²), and obese III (>40 kg/m²).

Biochemical parameters and scores changes

In the compliant group, at the end of the study, there were significantly lower serum levels of low-density lipoprotein (LDL in mg/dl calculated by Friedewald’s formula; p=0.009), and very low-density lipoproteins (VLDL in mg/dl; p≤0.001). LDL decreased by a mean percent change of 19.93% from baseline in the compliant group compared to 11.41% in the non-compliant group, with a statistically significant difference between groups (p=0.002). The number of patients that reached normal LDL levels (<130 mg/dl) was not significantly higher in the compliant group (p=0.136; Figure 3³⁸). TG decreased by a significantly higher mean percent change of 16.48% from baseline in the compliant group compared to 6.24% in the non-compliant group, with a statistically significant difference between groups (p<0.001).HDL (mg/dl) increased by 18.57%±15.18 in the compliant group and 16.40%±19.01 in the non-compliant group but was significantly higher (p=0.010) in compliant group at the endpoint. At the end of the study, significantly higher percentage of compliant participants attained a normalized HDL (>50; p=0.004), and normalized serum total cholesterol levels (<200 mg/dl; p=0.002; Figure 3). At the end of the study, there were no significant differences between studied groups regarding FBG (mg/dl; p=0.209), fasting insulin (FI; μU/ml; p=0.179), HOMA score (p=0.193), serum albumin (P=0.052), AST (P=0.115) and ALT (p=0.405). Also the percentage change from baseline was non-significant for these variables in the compliant group (p=0.073 for FBG, p=0.221 for FI, and p=0.089 for HOMA score).

Figure 3. End-point comparison of percentage of participants reaching normal levels of biochemical parameters and scores between studied groups.

ALT; Alanine Aminotransferase; AST: Aspartate Aminotransferase, FBG: Fasting Blood Glucose; FBI: Fasting Blood Insulin; HOMA-IR: Homeostasis Model of Assessment-Insulin Resistance; HDL-C: High density Lipoproteins-cholesterol; LDL-C: Low Density Lipoproteins-cholesterol; TC: Total Cholesterol; TG: Triglycerides,

Normal ranges: AST= 10-42 U/L; ALT (N=10-45U/L); TC<200 mg/dl; TG <150mg/dl; LDL <130 mg/dl and HDL; >50 mg/dl.

*Statistically significant difference p≤0.05 as compared to non-compliant.

NAFLD clinical and radiological parameters changes

At the endpoint, as seen in Figure 2,³⁸ the compliant group showed a statistically significant higher number of participants with absent dyspeptic symptoms (p<0.0010), hepatomegaly (p= 0.027) and also with improved NAFLD fibrosis score (p=0.0047), radiological steatosis (p=0.009) and fibrosis (p<0.001) grades.

Discussion

There is no doubt that disease state management by a multi-specialty-health care team has a multitude of advantages, including reducing the pressure on healthcare systems and attainment of improved health care outcomes both to patients and health care institutions. NAFLD is one of the diseases that can benefit the most of being handled by a multidisciplinary approach and this is due to its multiple comorbidity nature.²⁹ Pharmacists are considered one of the most trustworthy and accessible health care professionals, and are ideally situated to provide patient counseling regarding disease state, life style changes and medication.¹^,³⁰ Pharmacists have a crucial role in enhancing patient health and medication literacy, thus ensuring patient concordance.¹⁷

The AASLD recommendation for management of NAFLD prioritizes weight loss via dietary modification alone or with exercise.³¹ The impact of managing both NAFLD and metabolic co-morbidities chiefly include improvement of anthropometric and metabolic parameters Previous studies have reported a positive impact of incorporation of a pharmacist in patient care, in terms of achieving desired goals, reverting to non-metabolic syndrome status, and improved lifestyle modification.³²^–³⁴

In the current study, the more significant reduction in participant anthropometric measures in the compliant group, including weight reduction (p=0.003), shifting to an improved BMI category (p=0.008) and waist circumference normalization (p=0.004), was in accordance with the results of several pharmacist-led interventions. A previous systematic review has evaluated the effectiveness of community pharmacist’ weight management interventions, including dietary and physical activity recommendations and follow up in obese patients with obesity related co-morbidities including diabetes, hypertension, depression and gastroesophageal reflux disease. The review reported a statistically significant weight loss at 6 months in three studies.³⁵ The three studies showed an average weight loss of 5.6 kg, 5.1 kg and 5-kg, all much less compared to the average weight loss of 10 kg in the compliant group and 8.5 kg in the non-compliant group in the current study.

Similarly, in a study that enrolled obese patients with comorbidities including DM, hypertension, and/or dyslipidemia, a six month pharmacist led weight loss intervention resulted in a statistically significant reduction in weight (mean loss of 5 kg representing 4.5% from baseline mean, p<0.001), BMI (p<0.001) and waist circumference (p=0.002).³⁶ This is again less than the findings of the current study, which showed a mean percent weight loss of 11.66%±5.77 in the compliant group and 8.39%±6.05 in the non-compliant group, with a significance of p=0.007.

In a study conducted by Hammad et al (2011) in Jordan, to compare the effect of a pharmacist-physician collaborative practice versus usual care in 199 patients with metabolic syndrome, 39.1% of patients receiving pharmacist recommendations and counseling versus 24.7% of usual care patients were successfully shifted from a status of metabolic syndrome to no metabolic syndrome (p=0.032).³² Similarly, the current study showed a reduction in the number of patients with metabolic syndrome at the end of the study, although this was non-significant (p=0.37).

Concerning the laboratory outcomes there were also some studies that agree with the findings of the current study. The non-controlled study conducted by Cording et al on 115 patients with dyslipidemia receiving treatment with a statin (57%), fibrates (17%) and those receiving no lipid-lowering medications (17%).³ After 12 months, LDL level decreased by 20%, HDL cholesterol increased by 11%, and triglycerides decreased by 19% relative to baseline. Overall, LDL goals were reached in 77% of the patients.³ Similarly, in the current study, a significantly higher number of compliant participants converted to normal serum total cholesterol levels compared to non-compliant participants (p=0.002) at the end of the study. The results of the current study are also in accordance with those obtained by Hammad et al, where the mean TG serum level declined by 30.9 mg/dl in the intervention group and by 14.5 mg/dl in the usual care group (p=0.029).³²

The positive radiological outcomes of NAFLD obtained in the current study by the pharmacist led counseling and education can’t be compared to similarly conducted studies, as to our knowledge there are none. The higher rate of therapeutic goal achievement in the current study and similarly conducted studies could be attributed to the quality time and individualized attention spent in group and individual patient education, counseling and follow-up that ensured better patient understanding of the disease process, possible complications of inappropriately managed disease and necessary lifestyle changes to manage the disease.

Study limitations and recommendations

The cost effectiveness of providing this service was not evaluated in the current study. Highlighting the potential long-term healthcare cost reduction secondary to clinical pharmacist implementation into multidisciplinary health team in the face of the expenses of recruiting clinical pharmacists, as well as the identifying the acceptance rate of pharmacist role by non-pharmacist professionals, can reinforce clinical pharmacist collaboration. Future larger scale research is warranted to evaluate the impact of clinical pharmacist collaboration in the management of NAFLD and metabolic morbidities.

Conclusions

The current study has provided significant evidence of the benefit of incorporating a clinical pharmacist in NAFLD patient counseling, education and follow up. This significantly facilitates reaching desired therapeutic goals of NAFLD and metabolic co-morbidities. Thus, the current study indicates that clinical pharmacists could be viable health care providers for such a patient population especially in the face of shortage of primary care provider time in developing countries.

Data availability

Underlying data

Figshare: Dr Nehal DATA.xlsx, https://doi.org/10.6084/m9.figshare.17104499.³⁷

This project contains the following underlying data:

• Dr Nehal DATA.xlsx (Raw DATA for compliant and noncompliant group)

Extended data

Figshare: Excel sheet of figures https://doi.org/10.6084/m9.figshare.18953414.³⁸

This project contains the following extended data:

• excel of fig 2.xlsx
• excel of fig 3.xlsx

Figshare: Health education material and diet schedule for NAFLD https://doi.org/10.6084/m9.figshare.18866309.²⁰

This project contains the following extended data:

• Health Education Material.docx (Health education material in Arabic)

Reporting guidelines

Figshare: CONSORT checklist, https://doi.org/10.6084/m9.figshare.18866306

Data are available under the terms of the Creative Commons Zero “No rights reserved” data waiver (CC0 1.0 Public domain dedication).

Consent

Written informed consent was obtained from all the patients to participate in clinical research and for publication of the patients’ clinical details. This research was conducted ethically in accordance with the World Medical Association Declaration of Helsinki.

References

1. Maulavizada H, Emmerton L, Hattingh HL: Can a pharmacy intervention improve the metabolic risks of mental health patients? Evaluation of a novel collaborative service. BMC Health Serv. Res. 2016; 16(1): 146. PubMed Abstract | Publisher Full Text
2. Ramser KL, et al.: Physician-Pharmacist Collaboration in the Management of Patients With Diabetes Resistant to Usual Care. Diabetes Spectr. 2008; 21(3): 209–214. Publisher Full Text
3. Cording MA, et al.: Development of a pharmacist-managed lipid clinic. Ann. Pharmacother. 2002; 36(5): 892–904. PubMed Abstract | Publisher Full Text
4. Carter BL, et al.: Physician and pharmacist collaboration to improve blood pressure control. Arch. Intern. Med. 2009; 169(21): 1996–2002. PubMed Abstract | Publisher Full Text
5. Murray MD, et al.: Effect of a pharmacist on adverse drug events and medication errors in outpatients with cardiovascular disease. Arch. Intern. Med. 2009; 169(8): 757–763. PubMed Abstract | Publisher Full Text
6. Kelly CJG, Booth G: Pharmacist-led structured care for patients with diabetic nephropathy. Br. J. Diabetes Vasc. Dis. 2008; 8(2): 86–88. Publisher Full Text
7. McLean DL, et al.: A randomized trial of the effect of community pharmacist and nurse care on improving blood pressure management in patients with diabetes mellitus: study of cardiovascular risk intervention by pharmacists-hypertension (SCRIP-HTN). Arch. Intern. Med. 2008; 168(21): 2355–2361. PubMed Abstract | Publisher Full Text
8. Mubarak N, et al.: A systematic review and meta-analysis of the impact of collaborative practice between community pharmacist and general practitioner on asthma management. J Asthma Allergy. 2019; 12: 109–153. PubMed Abstract | Publisher Full Text
9. Hesso I, Gebara SN, Kayyali R: Impact of community pharmacists in COPD management: Inhalation technique and medication adherence. Respir. Med. 2016; 118: 22–30. PubMed Abstract | Publisher Full Text
10. Ando Y, Jou JH: Nonalcoholic Fatty Liver Disease and Recent Guideline Updates. Clin. Liver Dis. 2021; 17(1): 23–28. PubMed Abstract | Publisher Full Text
11. Younossi ZM, et al.: The economic and clinical burden of nonalcoholic fatty liver disease in the United States and Europe. Hepatology. 2016; 64(5): 1577–1586. Publisher Full Text
12. Browning JD, et al.: Prevalence of hepatic steatosis in an urban population in the United States: impact of ethnicity. Hepatology. 2004; 40(6): 1387–1395. Publisher Full Text
13. Angulo P, et al.: The NAFLD fibrosis score: a noninvasive system that identifies liver fibrosis in patients with NAFLD. Hepatology. 2007; 45(4): 846–854. PubMed Abstract | Publisher Full Text
14. Smith C, Neumiller JJ: Nonalcoholic Fatty Liver Disease Primer for Pharmacists. US Pharm. 2021; 46(10): HS-11–HS-15. Reference Source
15. Jorgenson D, et al.: Guidelines for pharmacists integrating into primary care teams. Can. Pharm. J. (Ott). 2013; 146(6): 342–352. PubMed Abstract | Publisher Full Text
16. Mallory AM, Angosta AD, Kawi J: A patient with metabolic syndrome and the role of the advanced practice registered nurse. Medsurg. Nurs. 2014; 23(4): 245–250. PubMed Abstract
17. DiDonato KL, May JR, Lindsey CC: Impact of wellness coaching and monitoring services provided in a community pharmacy. J. Am. Pharm. Assoc. (2003). 2013; 53(1): 14–21. Publisher Full Text
18. Elwakil R, et al.: Efficacy of adjuvant phosphatidylcholine in the management of egyptian patients with non alcoholic fatty liver disease (NAFLD). Medical & Clinical Research. 2021; 6(8): 669–677.
19. EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease . J. Hepatol. 2016; 64(6): 1388–1402. PubMed Abstract | Publisher Full Text
20. Seada N: Health education material and diet plans for NAFLD. figshare. Conference contribution.2022.
21. Oldridge NB: Cardiac rehabilitation exercise programme. Compliance and compliance-enhancing strategies. Sports Med. 1988; 6(1): 42–55. Publisher Full Text
22. Manning DS, Afdhal NH: Diagnosis and quantitation of fibrosis. Gastroenterology. 2008; 134(6): 1670–1681. Publisher Full Text
23. Petta S, et al.: Serial combination of non-invasive tools improves the diagnostic accuracy of severe liver fibrosis in patients with NAFLD. Aliment. Pharmacol. Ther. 2017; 46(6): 617–627. PubMed Abstract | Publisher Full Text
24. Alberti KG, Zimmet P, Shaw J: Metabolic syndrome--a new world-wide definition. A Consensus Statement from the International Diabetes Federation. Diabet. Med. 2006; 23(5): 469–480. PubMed Abstract | Publisher Full Text
25. Raj P, et al.: Optimizing observer performance of clinic blood pressure measurement: a position statement from the Lancet Commission on Hypertension Group. J. Hypertens. 2019; 37: 1.
26. Grundy SM, et al.: Diagnosis and Management of the Metabolic Syndrome. Circulation. 2005; 112(17): 2735–2752. Publisher Full Text
27. Muniyappa R, et al.: Current approaches for assessing insulin sensitivity and resistance in vivo: advantages, limitations, and appropriate usage. Am. J. Physiol. Endocrinol. Metab. 2008; 294(1): E15–E26. PubMed Abstract | Publisher Full Text
28. Mishra P, et al.: Descriptive statistics and normality tests for statistical data. Ann. Card. Anaesth. 2019; 22(1): 67–72. PubMed Abstract | Publisher Full Text
29. Lazarus JV, et al.: Defining comprehensive models of care for NAFLD. Nat. Rev. Gastroenterol. Hepatol. 2021; 18(10): 717–729. PubMed Abstract | Publisher Full Text
30. Peletidi A, R.: Kayyali Evaluation of pharmacy-led weight management service to minimise the risk of cardiovascular disease. J. Pharm. Policy Pract. 2021; 14: 54. PubMed Abstract | Publisher Full Text
31. Chalasani N, et al.: The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018; 67(1): 328–357. PubMed Abstract | Publisher Full Text
32. Hammad EA, et al.: A randomized controlled trial to assess pharmacist- physician collaborative practice in the management of metabolic syndrome in a university medical clinic in Jordan. J. Manag. Care Pharm. 2011; 17(4): 295–303. PubMed Abstract | Publisher Full Text
33. Plaster CP, et al.: Reduction of cardiovascular risk in patients with metabolic syndrome in a community health center after a pharmaceutical care program of pharmacotherapy follow-up. Braz. J. Pharm. Sci. 2012; 48: 435–446. Publisher Full Text
34. Azevedo M, et al.: Effectiveness of home pharmaceutical interventions in metabolic syndrome: A randomized controlled trial. Brazilian. J. Pharm. Sci. 2017; 53. Publisher Full Text
35. Gordon J, Watson M, Avenell A: Lightening the load? A systematic review of community pharmacy-based weight management interventions. Obes. Rev. 2011; 12(11): 897–911. PubMed Abstract | Publisher Full Text
36. Harmon M, Pogge E, Boomershine V: Evaluation of a pharmacist-led, 6-month weight loss program in obese patients. J. Am. Pharm. Assoc. (2003). 2014; 54(3): 302–307. PubMed Abstract | Publisher Full Text
37. Seada N: Dr Nehal DATA.xlsx. figshare. Dataset.2022.
38. Seada N: Excel sheet of figures. figshare. Figure.2022.

Comments on this article Comments (0)

Version 1

VERSION 1 PUBLISHED 24 Feb 2022

Author details Author details

¹ Clinical Pharmacy Unit, Ain Shams University Specialized Hospital, Cairo, Egypt
² Clinical Pharmacy Department, Ain Shams University, Cairo, Egypt
³ Department of Tropical Medicine, Faculty of Medicine Ain Shams University, Cairo, Egypt
⁴ Department of Biochemistry and Biotechnology, Heliopolis University, Cairo, Egypt
⁵ Department of Clinical Pharmacy, Faculty of Pharmacy Al Menoufiya, University, Al Menoufiya, Egypt

Nehal Abou Seada
Roles: Conceptualization, Formal Analysis, Investigation, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Manal El Hamamsy
Roles: Conceptualization, Project Administration, Supervision, Writing – Review & Editing

Sarah Shaheen
Roles: Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing

Reda Elwakil
Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing

Alaa Barakat
Roles: Conceptualization, Resources, Supervision

Azza El‐Sayed Mansy
Roles: Conceptualization, Data Curation, Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (1)

version 1

Published: 24 Feb 2022, 11:234

https://doi.org/10.12688/f1000research.77415.1

Copyright

© 2022 Abou Seada N et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Download

Export To

metrics

	Views	Downloads
F1000Research	-	-
PubMed Central Data from PMC are received and updated monthly.	-	-

Citations

0

SEE MORE DETAILS

CITE

how to cite this article

Abou Seada N, El Hamamsy M, Shaheen S et al. The impact of clinical pharmacist-led health education on the disease course of non-alcoholic fatty liver disease patients: an interventional study [version 1; peer review: 3 approved with reservations]. F1000Research 2022, 11:234 (https://doi.org/10.12688/f1000research.77415.1)

NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.

track

receive updates on this article

Track an article to receive email alerts on any updates to this article.

Open Peer Review

Current Reviewer Status: ?

Key to Reviewer Statuses VIEW HIDE

ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions

Version 1

VERSION 1

PUBLISHED 24 Feb 2022

Views

180

Reviewer Report 27 Jul 2022

Bernhard Langer, Department of Health, Nursing, Management, University of Applied Sciences Neubrandenburg, Neubrandenburg, Germany

Approved with Reservations

https://doi.org/10.5256/f1000research.81400.r143239

Many thanks to F1000Research for letting me review this interesting article. I enjoyed reading the manuscript. However, I have many comments for improvement. Pages in this text refer to the pdf file of the manuscript.

TRIAL REGISTRATION:
... Continue reading

Many thanks to F1000Research for letting me review this interesting article. I enjoyed reading the manuscript. However, I have many comments for improvement. Pages in this text refer to the pdf file of the manuscript.

TRIAL REGISTRATION:

Page 3: why did you not register the trial before the beginning of the data collection?

TITLE:

Adequate.

ABSTRACT:

In general, adequate.

Page 2: "…dyspeptic symptoms (p<0.0010)…” You mean p<0.001, right?

BACKGROUND:

In general, very well written with a very clear argumentation and expression.

Page 3: you mention an FDA-approved measure, but are there any measures/guidelines in Egypt? If so, what is the content?

Page 3: "...health professional..." 's' is missing, right?

METHODS:

Page 3: you should add the fact that the study is not randomized to the limitations. Why did you not opt for a randomized study design? Is the reason perhaps that the group division should then have been done at the beginning of the study, but compliance cannot be guaranteed? Perhaps you could also discuss this or other reasons in the limitations.

Page 3 and 4: the study described under Clinicaltrials.gov NCT04411862 is not the study reported in this paper, right? But why did you mention the registration in Clinicaltrials.gov? In your previous work (same trial?) published in reference 18, you reported that the study was conducted between January 2015 and January 2019, in your manuscript this timeline is between January 2016 and January 2019. Please revise accordingly.

The relation between the two studies (study mentioned in reference 18 and this study) is unclear. Please explain it more detailed.

Page 3: please describe the recruitment process in a little more detail.

Page 3: “Due to the reporting of multiple primary outcomes a number of least 100 patients for both arms together were considered sufficient to achieve an alpha error of 5% and a beta error of 1%.” Could you please cite an appropriate reference for this statement? Why didn't you perform a formal sample size calculation (formula or G*Power software)?

Page 4: The question is how sustainable the intervention is. For this purpose, it would have made sense to conduct a further follow-up after, say, another three or six months. Or do the authors assume or suggest that the intervention should be "permanent"? In this case, however, the question of the costs of the intervention or the cost-benefit ratio arises all the more. Perhaps the authors should add these aspects to the limitations.

Page 4: MetS: Please write out and abbreviation in brackets, as mentioned for the first time in the main text.

Page 4: “…hip circumference…” This outcome is not reported in the RESULTS section. Please revise accordingly.

Page 5: I believe that a consistent specification of effect sizes (Cramer's V for categorical data and, for example, Cohen's d for continuous data) could improve your analysis. Please also provide an appropriate interpretation according to Cohen (1992).¹ See also: https://www.socscistatistics.com/effectsize/default3.aspx.

Page 5: “…for normality using the Kolmogorov-Smirnov test.” Yes, but you did not specify whether the data is normally distributed or not and what conclusion to draw from it. Please revise accordingly.

Page 5: “Quantitative…” Wrong expression: you mean "Continuous", right?

Page 5: “…and as median and interquartile ranges if non-parametric.” Yes, but in the RESULTS, you always report mean and SD. Thus, why did you mention median and IQR in this section?

Page 5:” Qualitative…” Wrong expression, you mean "Categorial", right?

Page 5: “Independent-samples t-tests were used to compare two samples of quantitative parametric means.” Better: “Parametric independent t-tests were used to determine whether there is a statistically significant difference between the means in two unrelated groups.”

Page 5: “Post-hoc comparisons were conducted using the Bonferroni correction method.” Perhaps you could explain in a bit more detail why you made an adjustment for multiple testing (perhaps multiple primary endpoints?). You should also provide an appropriate reference, for example Bender and Lange (2001).² Also, you have not reported Bonferroni corrections for the P values in your RESULTS section. Please revise accordingly.

Page 5: "…qualitative…“ Wrong expression, you mean "categorial", right? Please revise accordingly.

Page 5: “The chi-square test was used to compare qualitative parameters.” Better: “Chi-Square Tests were used to determine whether there is an association between categorical variables.” Please revise accordingly.

RESULTS:

Page 6: In general, reporting of results can be improved because it is sometimes confusing (e.g., text and Figure 3).

Page 6, table 1: Is it possible to compare the compliant and non-compliant group with respect to other baseline variables? Please revise accordingly.

Page 6, table 1: There is no space between some numbers. Please revise accordingly.

Page 6, figure 2: Please always show three decimal places. Please revise accordingly.

Page 6, figure 2: In the figure you use the wording “Fibrosis stage”, in the text you use the wording “fibrosis grade”. Please revise accordingly.

Page 6, figure 2: “Dyspeptic syndrome presence”. This outcome variable was not mentioned in the METHODS. Please revise accordingly.

Page 6, figure 2: “Heptomegy presence”. Are you sure that this is the right wording? Also, this outcome variable was not mentioned in the METHODS. Please revise accordingly.

Page 7, figure 3: On the x-axis, FI is reported, but in the legend, you reported FBI. Please revise accordingly.

Page 7, legend of figure 3: Reporting of normal ranges for VLDL is missing. Please revise accordingly.

Page 8: “…(p<0.001).HDL…” There is no space between the two sentences. Please revise accordingly.

Page 8: “…fasting insulin (FI;…” FI or FBI? Please revise accordingly.

Page 8: "…dyspeptic symptoms (p<0.0010)…” You mean p<0.001, right?

Page 8: “…improved NAFLD fibrosis score (p=0.0047)…” But in Figure 2 you reported a P-value of 0.049. Please revise accordingly.

Page 8: “…fibrosis (p<0.001) grades.” But in Figure 2, you reported a P-value of 0.66, right? Please revise accordingly.

DISCUSSION:

Generally, well written. Avoid reporting detailed results already listed in the RESULTS section. Please revise accordingly.

Page 8: “The impact of managing both NAFLD and metabolic co-morbidities chiefly include improvement of anthropometric and metabolic parameters”. Full stop is missing. Please revise accordingly.

Page 8: “…all much less compared to the average weight loss of 10 kg in the compliant group and 8.5 kg in the non-compliant group in the current study.” Avoid reporting results in the discussion that were NOT reported in the RESULTS section. Please revise accordingly.

CONCLUSIONS:

Adequate.

REFERENCES:

Reference 11 and 12: why is there no PubMed link, because this journal is indexed by PubMed since 1981?

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

Partly
Are sufficient details of methods and analysis provided to allow replication by others?

Yes
If applicable, is the statistical analysis and its interpretation appropriate?

Partly
Are all the source data underlying the results available to ensure full reproducibility?

Yes
Are the conclusions drawn adequately supported by the results?

Yes

References

1. Cohen J: A power primer.Psychol Bull. 1992; 112 (1): 155-9 PubMed Abstract | Publisher Full Text
2. Bender R, Lange S: Adjusting for multiple testing—when and how?. Journal of Clinical Epidemiology. 2001; 54 (4): 343-349 Publisher Full Text

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Pharmacy Practice; Health Policy; Health Care Financing; Quality Improvement

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

CITE

Report a concern

Respond or Comment

Views

111

Reviewer Report 27 Jul 2022

Doaa El Amrousy, Tanta University Hospital, Tanta, Egypt

Approved with Reservations

https://doi.org/10.5256/f1000research.81400.r143241

i reviewed with interest the study titled "The impact of clinical pharmacist-led health education on the disease course of non-alcoholic fatty liver disease patients: an interventional study" which aimed to evaluate the impact of clinical pharmacist education, counseling and follow ... Continue reading

i reviewed with interest the study titled "The impact of clinical pharmacist-led health education on the disease course of non-alcoholic fatty liver disease patients: an interventional study" which aimed to evaluate the impact of clinical pharmacist education, counseling and follow up on the management of 102 p-atients NAFLD with MetS. the study is well designed, well written and the methodology was sound. but i have few comments:

Abbreviations should be defined the first time they are mentioned e.g EASL.....
Study design: it appears like a clinical trial to evaluate the effect of pharmacist health education on patients with NAFLD. Did you register this trial?
Sample size details is needed e.g. on which outcome you estimate the sample size and what is the effect size? Program used?
Second paragraph under the title "sample size" is not related to this title at all. It is actually related to study intervention and follow up.
Under "at the end of the study" title: you mentioned the number of patients who were compliant and who were not. this is result and is not appropriate to be mentioned here.
"Outcomes": most of the details under this study is related to the study measurements and should not be mentioned here e.g radiological details. just mention the outcomes without mention the mesaurements details which should be moved under the title " study measurements"

Is the work clearly and accurately presented and does it cite the current literature?

Yes
Is the study design appropriate and is the work technically sound?

Yes
Are sufficient details of methods and analysis provided to allow replication by others?

Partly
If applicable, is the statistical analysis and its interpretation appropriate?

Yes
Are all the source data underlying the results available to ensure full reproducibility?

Partly
Are the conclusions drawn adequately supported by the results?

Yes

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: pediatric gastroenterology

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

CITE

Report a concern

Respond or Comment

Views

168

Reviewer Report 11 Mar 2022

Giovanni Tarantino, Department of Clinical Medicine and Surgery, Federico II University Medical School of Naples, Naples, Italy

Approved with Reservations

https://doi.org/10.5256/f1000research.81400.r125472

This study investigated the impact of clinical pharmacist-led health education on the disease course of non-alcoholic fatty liver disease patients. The topic is interesting, and the manuscript is well written. The introduction covered the main ideas investigated in the study.
... Continue reading

This study investigated the impact of clinical pharmacist-led health education on the disease course of non-alcoholic fatty liver disease patients. The topic is interesting, and the manuscript is well written. The introduction covered the main ideas investigated in the study.
All data of surface roughness are available. The discussion explained the results thoroughly.

However, some minor comments are suggested for the authors to consider.

Authors should comment on the fact that HOMA did not show any change between the two groups, even though several other parameters changed significantly, at the light that insulin resistance is the driver of NAFLD and for some other authors is the consequence as clearly presented in Gastaldelli (2017).¹

In the discussion, give a brief account of the limitations of your study. This paragraph should be expanded pointing on the lack of determination of some inflammatory indices such as cytokines, about which there are a lot of pieces of research, specifically interleukin-17, linking NAFLD to the most frequent co-morbidity that is atherosclerosis as evident.² ³

The authors also did not mention sample size/power calculation.

Is the work clearly and accurately presented and does it cite the current literature?

Yes
Is the study design appropriate and is the work technically sound?

Yes
Are sufficient details of methods and analysis provided to allow replication by others?

Yes
If applicable, is the statistical analysis and its interpretation appropriate?

Yes
Are all the source data underlying the results available to ensure full reproducibility?

Yes
Are the conclusions drawn adequately supported by the results?

Partly

References

1. Gastaldelli A: Insulin resistance and reduced metabolic flexibility: cause or consequence of NAFLD?. Clinical Science. 2017; 131 (22): 2701-2704 Publisher Full Text
2. Tarantino G, Costantini S, Finelli C, Capone F, et al.: Is serum Interleukin-17 associated with early atherosclerosis in obese patients?. J Transl Med. 2014; 12: 214 PubMed Abstract | Publisher Full Text
3. Laurie RE, Lewis ET: Fertility control with Ovral. A clinical review.J Reprod Fertil Suppl. 1968; 5: Suppl 5:95-107 PubMed Abstract

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: NAFLD, Metabolic Syndrome, Atherosclerosis

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

CITE

Report a concern

Respond or Comment

Comments on this article Comments (0)

Version 1

VERSION 1 PUBLISHED 24 Feb 2022

Open Peer Review

Reviewer Status

Reviewer Reports

	Invited Reviewers
	1	2	3
Version 1 24 Feb 22	read	read	read

Giovanni Tarantino, Federico II University Medical School of Naples, Naples, Italy
Doaa El Amrousy, Tanta University Hospital, Tanta, Egypt
Bernhard Langer, University of Applied Sciences Neubrandenburg, Neubrandenburg, Germany

Comments on this article

All Comments(0)

Add a comment

Sign up for content alerts

Browse by related subjects

Back to all reports

Reviewer Report

180 Views

27 Jul 2022 | for Version 1

Bernhard Langer, Department of Health, Nursing, Management, University of Applied Sciences Neubrandenburg, Neubrandenburg, Germany

180 Views Cite this report Responses(0)

Approved With Reservations

Many thanks to F1000Research for letting me review this interesting article. I enjoyed reading the manuscript. However, I have many comments for improvement. Pages in this text refer to the pdf file of the manuscript.

TRIAL REGISTRATION:

Page 3: why did you not register the trial before the beginning of the data collection?

TITLE:

Adequate.

ABSTRACT:

In general, adequate.

Page 2: "…dyspeptic symptoms (p<0.0010)…” You mean p<0.001, right?

BACKGROUND:

In general, very well written with a very clear argumentation and expression.

Page 3: you mention an FDA-approved measure, but are there any measures/guidelines in Egypt? If so, what is the content?

Page 3: "...health professional..." 's' is missing, right?

METHODS:

Page 3: you should add the fact that the study is not randomized to the limitations. Why did you not opt for a randomized study design? Is the reason perhaps that the group division should then have been done at the beginning of the study, but compliance cannot be guaranteed? Perhaps you could also discuss this or other reasons in the limitations.

Page 3 and 4: the study described under Clinicaltrials.gov NCT04411862 is not the study reported in this paper, right? But why did you mention the registration in Clinicaltrials.gov? In your previous work (same trial?) published in reference 18, you reported that the study was conducted between January 2015 and January 2019, in your manuscript this timeline is between January 2016 and January 2019. Please revise accordingly.

The relation between the two studies (study mentioned in reference 18 and this study) is unclear. Please explain it more detailed.

Page 3: please describe the recruitment process in a little more detail.

Page 3: “Due to the reporting of multiple primary outcomes a number of least 100 patients for both arms together were considered sufficient to achieve an alpha error of 5% and a beta error of 1%.” Could you please cite an appropriate reference for this statement? Why didn't you perform a formal sample size calculation (formula or G*Power software)?

Page 4: The question is how sustainable the intervention is. For this purpose, it would have made sense to conduct a further follow-up after, say, another three or six months. Or do the authors assume or suggest that the intervention should be "permanent"? In this case, however, the question of the costs of the intervention or the cost-benefit ratio arises all the more. Perhaps the authors should add these aspects to the limitations.

Page 4: MetS: Please write out and abbreviation in brackets, as mentioned for the first time in the main text.

Page 4: “…hip circumference…” This outcome is not reported in the RESULTS section. Please revise accordingly.

Page 5: I believe that a consistent specification of effect sizes (Cramer's V for categorical data and, for example, Cohen's d for continuous data) could improve your analysis. Please also provide an appropriate interpretation according to Cohen (1992).¹ See also: https://www.socscistatistics.com/effectsize/default3.aspx.

Page 5: “…for normality using the Kolmogorov-Smirnov test.” Yes, but you did not specify whether the data is normally distributed or not and what conclusion to draw from it. Please revise accordingly.

Page 5: “Quantitative…” Wrong expression: you mean "Continuous", right?

Page 5: “…and as median and interquartile ranges if non-parametric.” Yes, but in the RESULTS, you always report mean and SD. Thus, why did you mention median and IQR in this section?

Page 5:” Qualitative…” Wrong expression, you mean "Categorial", right?

Page 5: “Independent-samples t-tests were used to compare two samples of quantitative parametric means.” Better: “Parametric independent t-tests were used to determine whether there is a statistically significant difference between the means in two unrelated groups.”

Page 5: “Post-hoc comparisons were conducted using the Bonferroni correction method.” Perhaps you could explain in a bit more detail why you made an adjustment for multiple testing (perhaps multiple primary endpoints?). You should also provide an appropriate reference, for example Bender and Lange (2001).² Also, you have not reported Bonferroni corrections for the P values in your RESULTS section. Please revise accordingly.

Page 5: "…qualitative…“ Wrong expression, you mean "categorial", right? Please revise accordingly.

Page 5: “The chi-square test was used to compare qualitative parameters.” Better: “Chi-Square Tests were used to determine whether there is an association between categorical variables.” Please revise accordingly.

RESULTS:

Page 6: In general, reporting of results can be improved because it is sometimes confusing (e.g., text and Figure 3).

Page 6, table 1: Is it possible to compare the compliant and non-compliant group with respect to other baseline variables? Please revise accordingly.

Page 6, table 1: There is no space between some numbers. Please revise accordingly.

Page 6, figure 2: Please always show three decimal places. Please revise accordingly.

Page 6, figure 2: In the figure you use the wording “Fibrosis stage”, in the text you use the wording “fibrosis grade”. Please revise accordingly.

Page 6, figure 2: “Dyspeptic syndrome presence”. This outcome variable was not mentioned in the METHODS. Please revise accordingly.

Page 6, figure 2: “Heptomegy presence”. Are you sure that this is the right wording? Also, this outcome variable was not mentioned in the METHODS. Please revise accordingly.

Page 7, figure 3: On the x-axis, FI is reported, but in the legend, you reported FBI. Please revise accordingly.

Page 7, legend of figure 3: Reporting of normal ranges for VLDL is missing. Please revise accordingly.

Page 8: “…(p<0.001).HDL…” There is no space between the two sentences. Please revise accordingly.

Page 8: “…fasting insulin (FI;…” FI or FBI? Please revise accordingly.

Page 8: "…dyspeptic symptoms (p<0.0010)…” You mean p<0.001, right?

Page 8: “…improved NAFLD fibrosis score (p=0.0047)…” But in Figure 2 you reported a P-value of 0.049. Please revise accordingly.

Page 8: “…fibrosis (p<0.001) grades.” But in Figure 2, you reported a P-value of 0.66, right? Please revise accordingly.

DISCUSSION:

Generally, well written. Avoid reporting detailed results already listed in the RESULTS section. Please revise accordingly.

Page 8: “The impact of managing both NAFLD and metabolic co-morbidities chiefly include improvement of anthropometric and metabolic parameters”. Full stop is missing. Please revise accordingly.

Page 8: “…all much less compared to the average weight loss of 10 kg in the compliant group and 8.5 kg in the non-compliant group in the current study.” Avoid reporting results in the discussion that were NOT reported in the RESULTS section. Please revise accordingly.

CONCLUSIONS:

Adequate.

REFERENCES:

Reference 11 and 12: why is there no PubMed link, because this journal is indexed by PubMed since 1981?

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

Partly
Are sufficient details of methods and analysis provided to allow replication by others?

Yes
If applicable, is the statistical analysis and its interpretation appropriate?

Partly
Are all the source data underlying the results available to ensure full reproducibility?

Yes
Are the conclusions drawn adequately supported by the results?

Yes

References

1. Cohen J: A power primer.Psychol Bull. 1992; 112 (1): 155-9 PubMed Abstract | Publisher Full Text
2. Bender R, Lange S: Adjusting for multiple testing—when and how?. Journal of Clinical Epidemiology. 2001; 54 (4): 343-349 Publisher Full Text

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Pharmacy Practice; Health Policy; Health Care Financing; Quality Improvement

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Respond to this report

Responses (0)

Back to all reports

Reviewer Report

111 Views

27 Jul 2022 | for Version 1

Doaa El Amrousy, Tanta University Hospital, Tanta, Egypt

111 Views Cite this report Responses(0)

Approved With Reservations

i reviewed with interest the study titled "The impact of clinical pharmacist-led health education on the disease course of non-alcoholic fatty liver disease patients: an interventional study" which aimed to evaluate the impact of clinical pharmacist education, counseling and follow up on the management of 102 p-atients NAFLD with MetS. the study is well designed, well written and the methodology was sound. but i have few comments:

Abbreviations should be defined the first time they are mentioned e.g EASL.....
Study design: it appears like a clinical trial to evaluate the effect of pharmacist health education on patients with NAFLD. Did you register this trial?
Sample size details is needed e.g. on which outcome you estimate the sample size and what is the effect size? Program used?
Second paragraph under the title "sample size" is not related to this title at all. It is actually related to study intervention and follow up.
Under "at the end of the study" title: you mentioned the number of patients who were compliant and who were not. this is result and is not appropriate to be mentioned here.
"Outcomes": most of the details under this study is related to the study measurements and should not be mentioned here e.g radiological details. just mention the outcomes without mention the mesaurements details which should be moved under the title " study measurements"

Is the work clearly and accurately presented and does it cite the current literature?

Yes
Is the study design appropriate and is the work technically sound?

Yes
Are sufficient details of methods and analysis provided to allow replication by others?

Partly
If applicable, is the statistical analysis and its interpretation appropriate?

Yes
Are all the source data underlying the results available to ensure full reproducibility?

Partly
Are the conclusions drawn adequately supported by the results?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

pediatric gastroenterology

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Respond to this report

Responses (0)

Back to all reports

Reviewer Report

168 Views

11 Mar 2022 | for Version 1

Giovanni Tarantino, Department of Clinical Medicine and Surgery, Federico II University Medical School of Naples, Naples, Italy

168 Views Cite this report Responses(0)

Approved With Reservations

This study investigated the impact of clinical pharmacist-led health education on the disease course of non-alcoholic fatty liver disease patients. The topic is interesting, and the manuscript is well written. The introduction covered the main ideas investigated in the study.
All data of surface roughness are available. The discussion explained the results thoroughly.

However, some minor comments are suggested for the authors to consider.

Authors should comment on the fact that HOMA did not show any change between the two groups, even though several other parameters changed significantly, at the light that insulin resistance is the driver of NAFLD and for some other authors is the consequence as clearly presented in Gastaldelli (2017).¹

In the discussion, give a brief account of the limitations of your study. This paragraph should be expanded pointing on the lack of determination of some inflammatory indices such as cytokines, about which there are a lot of pieces of research, specifically interleukin-17, linking NAFLD to the most frequent co-morbidity that is atherosclerosis as evident.² ³

The authors also did not mention sample size/power calculation.

Is the work clearly and accurately presented and does it cite the current literature?

Yes
Is the study design appropriate and is the work technically sound?

Yes
Are sufficient details of methods and analysis provided to allow replication by others?

Yes
If applicable, is the statistical analysis and its interpretation appropriate?

Yes
Are all the source data underlying the results available to ensure full reproducibility?

Yes
Are the conclusions drawn adequately supported by the results?

Partly

References

1. Gastaldelli A: Insulin resistance and reduced metabolic flexibility: cause or consequence of NAFLD?. Clinical Science. 2017; 131 (22): 2701-2704 Publisher Full Text
2. Tarantino G, Costantini S, Finelli C, Capone F, et al.: Is serum Interleukin-17 associated with early atherosclerosis in obese patients?. J Transl Med. 2014; 12: 214 PubMed Abstract | Publisher Full Text
3. Laurie RE, Lewis ET: Fertility control with Ovral. A clinical review.J Reprod Fertil Suppl. 1968; 5: Suppl 5:95-107 PubMed Abstract

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

NAFLD, Metabolic Syndrome, Atherosclerosis

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Respond to this report

Responses (0)

[1] 1. Maulavizada H, Emmerton L, Hattingh HL: Can a pharmacy intervention improve the metabolic risks of mental health patients? Evaluation of a novel collaborative service. BMC Health Serv. Res. 2016; 16(1): 146. PubMed Abstract | Publisher Full Text

[2] 2. Ramser KL, et al.: Physician-Pharmacist Collaboration in the Management of Patients With Diabetes Resistant to Usual Care. Diabetes Spectr. 2008; 21(3): 209–214. Publisher Full Text

[3] 3. Cording MA, et al.: Development of a pharmacist-managed lipid clinic. Ann. Pharmacother. 2002; 36(5): 892–904. PubMed Abstract | Publisher Full Text

[4] 4. Carter BL, et al.: Physician and pharmacist collaboration to improve blood pressure control. Arch. Intern. Med. 2009; 169(21): 1996–2002. PubMed Abstract | Publisher Full Text

[5] 5. Murray MD, et al.: Effect of a pharmacist on adverse drug events and medication errors in outpatients with cardiovascular disease. Arch. Intern. Med. 2009; 169(8): 757–763. PubMed Abstract | Publisher Full Text

[6] 6. Kelly CJG, Booth G: Pharmacist-led structured care for patients with diabetic nephropathy. Br. J. Diabetes Vasc. Dis. 2008; 8(2): 86–88. Publisher Full Text

[7] 7. McLean DL, et al.: A randomized trial of the effect of community pharmacist and nurse care on improving blood pressure management in patients with diabetes mellitus: study of cardiovascular risk intervention by pharmacists-hypertension (SCRIP-HTN). Arch. Intern. Med. 2008; 168(21): 2355–2361. PubMed Abstract | Publisher Full Text

[8] 8. Mubarak N, et al.: A systematic review and meta-analysis of the impact of collaborative practice between community pharmacist and general practitioner on asthma management. J Asthma Allergy. 2019; 12: 109–153. PubMed Abstract | Publisher Full Text

[9] 9. Hesso I, Gebara SN, Kayyali R: Impact of community pharmacists in COPD management: Inhalation technique and medication adherence. Respir. Med. 2016; 118: 22–30. PubMed Abstract | Publisher Full Text

[10] 10. Ando Y, Jou JH: Nonalcoholic Fatty Liver Disease and Recent Guideline Updates. Clin. Liver Dis. 2021; 17(1): 23–28. PubMed Abstract | Publisher Full Text

[11] 11. Younossi ZM, et al.: The economic and clinical burden of nonalcoholic fatty liver disease in the United States and Europe. Hepatology. 2016; 64(5): 1577–1586. Publisher Full Text

[12] 12. Browning JD, et al.: Prevalence of hepatic steatosis in an urban population in the United States: impact of ethnicity. Hepatology. 2004; 40(6): 1387–1395. Publisher Full Text

[13] 13. Angulo P, et al.: The NAFLD fibrosis score: a noninvasive system that identifies liver fibrosis in patients with NAFLD. Hepatology. 2007; 45(4): 846–854. PubMed Abstract | Publisher Full Text

[14] 14. Smith C, Neumiller JJ: Nonalcoholic Fatty Liver Disease Primer for Pharmacists. US Pharm. 2021; 46(10): HS-11–HS-15. Reference Source

[15] 15. Jorgenson D, et al.: Guidelines for pharmacists integrating into primary care teams. Can. Pharm. J. (Ott). 2013; 146(6): 342–352. PubMed Abstract | Publisher Full Text

[16] 16. Mallory AM, Angosta AD, Kawi J: A patient with metabolic syndrome and the role of the advanced practice registered nurse. Medsurg. Nurs. 2014; 23(4): 245–250. PubMed Abstract

[17] 17. DiDonato KL, May JR, Lindsey CC: Impact of wellness coaching and monitoring services provided in a community pharmacy. J. Am. Pharm. Assoc. (2003). 2013; 53(1): 14–21. Publisher Full Text

[18] 18. Elwakil R, et al.: Efficacy of adjuvant phosphatidylcholine in the management of egyptian patients with non alcoholic fatty liver disease (NAFLD). Medical & Clinical Research. 2021; 6(8): 669–677.

[19] 19. EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease . J. Hepatol. 2016; 64(6): 1388–1402. PubMed Abstract | Publisher Full Text

[20] 20. Seada N: Health education material and diet plans for NAFLD. figshare. Conference contribution.2022.

[21] 21. Oldridge NB: Cardiac rehabilitation exercise programme. Compliance and compliance-enhancing strategies. Sports Med. 1988; 6(1): 42–55. Publisher Full Text

[22] 22. Manning DS, Afdhal NH: Diagnosis and quantitation of fibrosis. Gastroenterology. 2008; 134(6): 1670–1681. Publisher Full Text

[23] 23. Petta S, et al.: Serial combination of non-invasive tools improves the diagnostic accuracy of severe liver fibrosis in patients with NAFLD. Aliment. Pharmacol. Ther. 2017; 46(6): 617–627. PubMed Abstract | Publisher Full Text

[24] 24. Alberti KG, Zimmet P, Shaw J: Metabolic syndrome--a new world-wide definition. A Consensus Statement from the International Diabetes Federation. Diabet. Med. 2006; 23(5): 469–480. PubMed Abstract | Publisher Full Text

[25] 25. Raj P, et al.: Optimizing observer performance of clinic blood pressure measurement: a position statement from the Lancet Commission on Hypertension Group. J. Hypertens. 2019; 37: 1.

[26] 26. Grundy SM, et al.: Diagnosis and Management of the Metabolic Syndrome. Circulation. 2005; 112(17): 2735–2752. Publisher Full Text

[27] 27. Muniyappa R, et al.: Current approaches for assessing insulin sensitivity and resistance in vivo: advantages, limitations, and appropriate usage. Am. J. Physiol. Endocrinol. Metab. 2008; 294(1): E15–E26. PubMed Abstract | Publisher Full Text

[28] 28. Mishra P, et al.: Descriptive statistics and normality tests for statistical data. Ann. Card. Anaesth. 2019; 22(1): 67–72. PubMed Abstract | Publisher Full Text

[29] 29. Lazarus JV, et al.: Defining comprehensive models of care for NAFLD. Nat. Rev. Gastroenterol. Hepatol. 2021; 18(10): 717–729. PubMed Abstract | Publisher Full Text

[30] 30. Peletidi A, R.: Kayyali Evaluation of pharmacy-led weight management service to minimise the risk of cardiovascular disease. J. Pharm. Policy Pract. 2021; 14: 54. PubMed Abstract | Publisher Full Text

[31] 31. Chalasani N, et al.: The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018; 67(1): 328–357. PubMed Abstract | Publisher Full Text

[32] 32. Hammad EA, et al.: A randomized controlled trial to assess pharmacist- physician collaborative practice in the management of metabolic syndrome in a university medical clinic in Jordan. J. Manag. Care Pharm. 2011; 17(4): 295–303. PubMed Abstract | Publisher Full Text

[33] 33. Plaster CP, et al.: Reduction of cardiovascular risk in patients with metabolic syndrome in a community health center after a pharmaceutical care program of pharmacotherapy follow-up. Braz. J. Pharm. Sci. 2012; 48: 435–446. Publisher Full Text

[34] 34. Azevedo M, et al.: Effectiveness of home pharmaceutical interventions in metabolic syndrome: A randomized controlled trial. Brazilian. J. Pharm. Sci. 2017; 53. Publisher Full Text

[35] 35. Gordon J, Watson M, Avenell A: Lightening the load? A systematic review of community pharmacy-based weight management interventions. Obes. Rev. 2011; 12(11): 897–911. PubMed Abstract | Publisher Full Text

[36] 36. Harmon M, Pogge E, Boomershine V: Evaluation of a pharmacist-led, 6-month weight loss program in obese patients. J. Am. Pharm. Assoc. (2003). 2014; 54(3): 302–307. PubMed Abstract | Publisher Full Text

[37] 37. Seada N: Dr Nehal DATA.xlsx. figshare. Dataset.2022.

[38] 38. Seada N: Excel sheet of figures. figshare. Figure.2022.

The impact of clinical pharmacist-led health education on the disease course of non-alcoholic fatty liver disease patients: an interventional study

Abstract

Keywords

Background

Methods

Study design and setting

Study participants

Sample size determination

Ethical concerns

Study intervention

Figure 1. Study design flow diagram.

At the end of the study

Study outcomes

Statistical analysis

Results

Table 1. Comparison of demographics and co-morbidities between study groups.

Anthropometric changes

Figure 2. End-point comparison of percentage of participants reaching normal levels of clinical parameters and scores between studied groups.

Table 2. BMI categories changes in studied groups.

Biochemical parameters and scores changes

Figure 3. End-point comparison of percentage of participants reaching normal levels of biochemical parameters and scores between studied groups.

NAFLD clinical and radiological parameters changes

Discussion

Study limitations and recommendations

Conclusions

Data availability

Underlying data

Extended data

Reporting guidelines

Consent

References

Comments on this article Comments (0)

Open Peer Review

Comments on this article Comments (0)

Open Peer Review

Reviewer Status

Reviewer Reports

Comments on this article

Browse by related subjects

Competing Interests Policy

Stay Updated