Medico-Legal Considerations on the Clinico-Instrumental Correlation and the Role of Expertise in the Dermatological Diagnostic Pathway

Reviewer 1

Authors’ replies

We have answered point-by-point reporting on the left side of this table reviewer suggestions and in the right Authors’ answers, with text changes reference. In the manuscript, revisions are made with Word track changes. Text additions are written with different colours and underlined, while deletions are shown with strikethrough. For improving readability, new sentences or revised paragraph are also highlighted in yellow, as new references in the References section. A clear manuscript is provided in pdf format.

I reviewed the manuscript with the title “Medico-Legal Considerations on the Clinico-Instrumental Correlation and the Role of Expertise in the Dermatological Diagnostic Pathway”.  

This is an interesting article highlighting importance of medical expertise, medical practice as well as patient safety and delay in diagnosis and legal guidelines.

Abstract : well written

Introduction : can be trimmed.

Lines 182-187: can be concise

Discussion: well written

Conclusion: in line with the article

References: need consistent formatting style

Overall, well written article.

Many thanks.

We have revised the introduction and the paragraph mentioned. References were reformatted. We have also taken the opportunity to improve the content and style of the text following overall reviewers’ suggestions. Sincerely LPT

Reviewer 2

Authors’ replies

We have answered point-by-point reporting on the left side of this table reviewer suggestions and in the right Authors’ answers, with text changes reference. In the manuscript, revisions are made with Word track changes. Text additions are written with different colours and underlined, while deletions are shown with strikethrough. For improving readability, new sentences or revised paragraph are also highlighted in yellow, as new references in the References section. A clear manuscript is provided in pdf format.

Dear Authors,

The manuscript is conceptually solid and presents a thoughtful medico-legal reflection on a relevant Italian court case. It effectively discusses the implications for dermatological diagnostic reasoning and documentation, emphasizing clinical judgment, traceability, and informed consent. However, some aspects can be improved to enhance clarity, structure, and scientific rigor before publication.

Many thanks. We have taken the opportunity to improve the content and style of the text following overall reviewers’ suggestions.

In the introduction section, the authors should provide a clearer justification for why this particular case is relevant internationally (not just in Italy). Consider framing the article’s objective explicitly at the end of the introduction.

We have overall revised the introduction, according to overall reviewers’ suggestions, revising and emphasising the aim (lines 58-66).

In the discussion section, strengthen the paragraph linking dermatological diagnostic discretion with medico-legal accountability, and clarify the concept of “defensive medicine” and explicitly relate it to dermatological practice. And the authors should emphasize that structured documentation (e.g., dermoscopic images, notes on morphology, patient consent) can legally protect the clinician without unnecessary instrumentalization.

Many thanks. We have revised the text in section “Dermatologist, diagnostic path and instrumental examinations” and integrated the text in particular at lines 178-189 and 196-200. Sincerely LPT

Reviewer 3

Authors’ replies

We have answered point-by-point reporting on the left side of this table reviewer suggestions and in the right Authors’ answers, with text changes reference. In the manuscript, revisions are made with Word track changes. Text additions are written with different colours and underlined, while deletions are shown with strikethrough. For improving readability, new sentences or revised paragraph are also highlighted in yellow, as new references in the References section. A clear manuscript is provided in pdf format.

The authors use this case to explore broader medico-legal principles regarding diagnostic appropriateness, the role of histopathological confirmation, burden of proof in dermatology, and the importance of clinical documentation. The manuscript argues that equating correctness exclusively with histological confirmation is neither clinically nor legally necessary in typical cases when clinical reasoning is adequately documented, and that requiring universal instrumental testing would transform appropriate diagnostic practice into defensive medicine. The structure of the paper effectively uses a specific case as a springboard for discussing general principles rather than attempting to reassess the individual ruling's factual merits.

There are several areas where the presentation could be strengthened, and some concerns warrant discussion:

Many thanks. We have taken the opportunity to improve the content and style of the text following your suggestions point-by-point addressed below.

Please, expand the discussion of what constitutes adequate documentation with concrete examples of different diagnostic scenarios. The authors recommend "a brief, structured note that records key morphology, dermoscopic clues when present, differential, and rationale for management," the paper would benefit from showing what this might look like in practice for common presentations versus rarer or more complex cases .

We have revised the overall discussing addressing clinical records relevance, also adding significant references. In particular see lines 304-317.

More thoroughly explore the burden of proof issue and propose realistic alternatives to universal histological confirmation. What standard of evidence would the authors find acceptable as proof of benignity? How might courts balance the need for defensible diagnosis against the risks of excessive testing?

Many thanks. We have revised the text in section “Dermatologist, diagnostic path and instrumental examinations” and integrated the text in particular at lines 178-189 and 196-200.

Please, acknowledge more explicitly the role of readily available technology (photography, dermoscopy) in modern dermatological practice and articulate why the absence of such documentation should not necessarily be held against practitioners in all contexts. This strengthens the argument by addressing the counterpoint that technology exists and should be utilized

We have revised the overall discussion in particular in Chapter 3.3 to address these issues and to provide clearer reflections.

You can also deepen the analysis of when reassessment and referral are indicated, particularly in cases of discordant findings such as unexpected intraoperative bleeding. Clear criteria would help readers understand the boundary between appropriate clinical judgment and substandard care.

Thank you. Overall, we have revised the discussion in Chapter 3.3 to address the issue of discordant findings and reasons for referral indication with respect to clinical practice and professional accountability.

You shall engage with temporal causality in the context of malignancy development at scar sites. How should courts weigh the temporal relationship between initial excision and subsequent malignancy diagnosis when determining whether malignancy was likely present at time zero?

We have revised the overall discussing addressing these aspects. In particular see lines 269-275.

  In the revision, develop more specific recommendations for scientific society working groups. What concrete objectives should these groups pursue? What deliverables would meaningfully improve clinical practice and reduce liability exposure for practitioners?

We have revised the overall discussing addressing these aspects. In particular see lines 339-343.

A particularly relevant addition to the manuscript would be engagement with recent literature on communicating dismal diagnoses and diagnostic uncertainty in clinical practice. Two recent publications deserve specific attention in this context. First, Ciccarese et al. (2025) in their comprehensive review "How to Effectively Communicate Dismal Diagnoses in Dermatology and Venereology: From Skin Cancers to Sexually Transmitted Infections" (https://pubmed.ncbi.nlm.nih.gov/39941165/) provide dermatology-specific frameworks for disclosing distressing diagnostic information, including established protocols such as SPIKES, ABCDE, and BREAKS. While their focus differs slightly from the medico-legal emphasis of the present manuscript, their work is directly relevant to the discussion of informed consent and patient communication in Section 3.3. The authors note that training in communication skills to facilitate breaking bad news improves both patient satisfaction and physician comfort, which has clear implications for litigation prevention and patient-centered care.

We agree. We have integrated the text briefly addressing in the 3.3 chapter the issues of communication and diagnosis uncertainty. See in particular lines 304-317.

Second, the retrospective analysis by Baez et al. (2025) examining medical malpractice claims in hysteroscopic procedures, (https://pubmed.ncbi.nlm.nih.gov/39942453/) offers valuable comparative insights into how different medical specialties face litigation risks related to procedural complications. Though hysteroscopy differs substantially from dermatological diagnosis, their systematic analysis of litigious trends, identifying that the most common adverse outcomes involve failure to recognize or properly manage complications, parallels the diagnostic delay concerns central to the DFSP case discussed here.

Many thanks for the reference provided and deepening of the topic. However, it should be noted that these are different contexts—diagnostic challenges versus procedural complications. Nevertheless, some insights from the medico-legal analysis of dermatology-related litigation have been provided in the introduction, which help contextualize the overall discussion of malpractice risk and highlight relevant trends within the specialty.

Your analysis of the Italian Court of Cassation ruling is insightful, and your argument that diagnostic appropriateness, rather than the mere presence or absence of confirmatory testing, should be the standard of care is compelling and well-reasoned. I believe that after the revision the paper will be important in the field.

We hope that the manuscript is clearer and more focused after overall revisions. Sincerely LPT