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Protocol Review: "Retrospective Evaluation of WBC Count, CRP, and Procalcitonin as Biomarkers for Assessing Antibiotic Therapy Outcomes in Hospitalized Patients"

Below is a structured review covering spelling/typographical errors, grammatical issues, factual/scientific concerns, structural issues, and suggestions for improvement.

1. Spelling & Typographical Errors

Location	Error Found	Correction
Cover page / Department name	"DEPARTMENT OF PHARMCY PRACTICE"	"DEPARTMENT OF PHARMACY PRACTICE" (missing letter "A")
Title (cover page)	Quotation marks are used around the title - this is non-standard for dissertation titles	Remove the outer quotation marks from the title
Address (Proforma row 01)	"A/P - NEJ TQ -- CHIKODI"	Should read "A/P - NEJ, TQ - CHIKODI" (use single dash, not double dash)

2. Structural / Formatting Issues

Location	Issue	Correction
Cover page	"M Pharm II SEM" - no period after "M"	Should read "M. Pharm II Sem" (consistent with rest of document)
Cover page	"B. Pharm" appears as a subscript after candidate name (~~B. Pharm~~) - appears to be formatted oddly	Should appear normally as a qualification, e.g. "SOUJANYA VIDYASAGAR NARASAI, B. Pharm"
Proforma table row 07, question 7.2	The question reads "Does the study require any Investigations on animals? If yes give details"	The correct/full wording for this standard RGUHS proforma item is: "Does the study require any investigations to be conducted on patients or other human or animals? If yes, please describe briefly." The proforma table abbreviates it but the Enclosure V heading correctly shows the full version - these two should be consistent
Need for Study vs Introduction	The document has both a "Need for the Study" section and a separate "Introduction" section that largely repeat the same content. In an RGUHS dissertation protocol, these are typically separate with no overlap. The "Need for Study" should focus specifically on the gap/justification, while "Introduction" covers background. Currently they repeat nearly identical content about WBC, CRP, and PCT.	Differentiate the two sections clearly
Enclosure labeling	Enclosure I = Need for Study, but Introduction appears under the same enclosure. This creates confusion - the main proforma table separates "6.1 Need for Study" and "6.2 Review of Literature" as distinct items, but "Introduction" text appears before the proper Literature Review.	Clearly label: Enclosure I = Need for Study; separate Introduction under 6.1 properly

3. Grammatical / Language Errors

Location	Error	Correction
Need for Study paragraph 1	"...accounting for a significant proportion of hospital admission, morbidity..."	Should be "hospital admissions" (plural)
Introduction, paragraph referencing WBC	"Elevated WBC counts are frequently associated with bacterial infections and may provide useful information regarding disease progression and therapeutic response. [3,4]" - references 3 and 4 in the reference list are Cecconi et al. (Sepsis and septic shock) and Wyllie et al. (Lymphopenia and bacteraemia)	These references are mismatched. Cecconi et al. 2018 (Lancet) is about sepsis, not WBC count in general. Wyllie et al. is about lymphopenia specifically. Better references for WBC as a general infection marker should be used here.
Enclosure V	"...does not require any investigation on the study subjects"	Since this is a retrospective record-based study, the correct phrase is "patients/subjects" - but more precisely, because it is purely retrospective record review, the sentence is correct in spirit. However, the wording could be clearer: "No patient contact or investigations are required; data will be collected from existing medical records only."
Section 7.3 (Enclosure VI)	"Yes, the study has been applied for ethical clearance Enclosed."	Grammatically awkward. Correct to: "Yes, the study has been submitted for ethical clearance. The approval letter is enclosed."

4. Scientific / Content Concerns

Location	Issue	Suggestion
Introduction	PCT threshold stated as >0.5 ng/mL for bacterial infection. This is the standard cut-off; however, the protocol should clarify which cut-off will be used for "baseline" vs "treatment response" (e.g., >50% decrease is commonly cited for de-escalation).	Add a note defining the specific PCT thresholds used for outcome assessment
Outcome Table (Enclosure IV)	"Reduction in WBC count ≥25%" and "Reduction in CRP ≥30%" and "Reduction in procalcitonin ≥50%" are listed as success criteria	These thresholds should be cited with references. The PCT ≥50% reduction is well-supported (e.g., Schuetz et al.), but the WBC ≥25% and CRP ≥30% thresholds need specific citation. Without citations they appear arbitrary.
Outcome Table	"Partial response" criteria include "reduction with incomplete clinical improvement" but no specific numeric thresholds are given for partial response	Define numeric cut-offs for partial response for consistency and reproducibility
Methodology	"Approximately 150-200 patient records" - no sample size calculation or justification is provided	For a retrospective study, a formal sample size justification (even convenience sampling rationale) should be stated. RGUHS reviewers may flag this.
Study design description	The study is described as both "observational" in the design section and then correctly as "retrospective observational" in the methodology.	Use consistent terminology throughout: "retrospective observational study" everywhere
Literature Review - Reference 18	Kofteridis DP et al. - described as studying "serum CRP and procalcitonin levels as markers of bacterial upper respiratory tract infections"	This description does not match standard Kofteridis publications which focus more on Legionella/pneumonia. Verify this reference before submission.
Literature Review - Reference 19	Póvoa P et al. - the accent on Póvoa is correct, but the reference list entry (Ref 6) spells it as "Povoa P" without the accent	Standardize spelling of author names across literature review text and reference list

5. Reference List Issues

Ref No.	Issue	Correction
Reference 10	Lippi G, Plebani M. Clin Chem Lab Med. 2010;48(9):117 - the page number is cut off/incomplete	Should end with full page range, e.g., "1173-83" or similar. Check original.
References generally	The reference list uses a mix of Vancouver style (numbered) which is appropriate for medical science. However, in-text citations in the Literature Review section use author names (e.g., "Schuetz P et al.", "Kofteridis DP et al.") which is a narrative citation style, while the Introduction uses numbered citations [1,2].	Choose one consistent citation style throughout. Narrative + numbered is acceptable if used consistently, but the style should match the RGUHS format requirement.
Reference 2	WHO 2014 Antimicrobial Resistance report is cited for the in-text claim about biomarkers being important - this is an appropriate supporting reference, but a more current WHO AMR report (2021 or 2023) would be stronger	Update to a more recent WHO reference if possible

6. Summary of Key Corrections Needed

Critical (must fix before submission):

"PHARMCY" → "PHARMACY" on the cover page
Add sample size justification/calculation
Fix the grammatically awkward sentence in Section 7.3
Verify and correct reference 10 (incomplete page number)
Add citations for the outcome thresholds (WBC ≥25%, CRP ≥30%)

Important (should fix): 6. Differentiate "Need for Study" from "Introduction" - currently duplicated 7. Standardize study design term to "retrospective observational" throughout 8. Standardize Póvoa / Povoa spelling 9. Fix mismatched references [3,4] in Introduction (WBC paragraph)

Minor (recommended): 10. Remove quotation marks from dissertation title on cover page 11. Address formatting of candidate qualification (B. Pharm subscript) 12. Clarify the outcome table with numeric partial response criteria 13. Consider updating WHO reference to post-2020 publication

Overall, the protocol is well-structured and scientifically sound. The main issues are: one critical spelling error on the cover page ("PHARMCY"), duplication between the Need for Study and Introduction sections, incomplete reference details, and a few citation-content mismatches in the literature review. Addressing these before submission will significantly strengthen the document.

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