Review Reports

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

There was a lot (probably too much) discussion of how we might think of regulation as being broader than just legislation, treaties, etc. that was theoretical, somewhat repetitive, and not clearly connected to AMR. When reading most of the first three pages, I wondered what exactly you were referring to and wanted concrete examples that were applicable to AMR. What specific tools are you talking about? I am also not sure that this much discussion of broader types of regulation was necessary in a paper of this nature, which is primarily about AMR rather than how we think about regulation. I would just cut to the chase and talk about the interviews.

To me, it would make far more sense to start with the section on AMR in primary care rather than the section theorizing on regulation. The former is very concrete, while the later is abstract. One might wonder why they are reading about how we define regulation without a concrete discussion of the actual problem that is being addressed (ie AMR in primary care). As such, I would strongly recommend that you flip these two sections.

I think it is stretching the definition of regulation to consider anyone who influences prescribing in some way to be a regulator (eg family and friends). I am also not sure that labelling them regulators advances our understanding of this issue or will lead us to solve the issue.

Author Response

Thank you to Reviewer 1 for their review of this manuscript. Responses to each query and suggestion are made in the attached response document.

 

Author Response File: Author Response.pdf

Reviewer 2 Report

Comments and Suggestions for Authors

The premise of the article is sound, that a decentred regulatory framework makes more sense in order to combat overprescription or usage of antibiotics leading to antimicrobial resistance (AMR).  However, there are two primary concerns that lead to my recommendation for major revision before publication.

First, in the Methods section discussion of the selected regulatory actors needs a more logical organization.  For example, the actors are listed without an explanation of their order.  For example, an order of frequency of concern or importance to patients would make sense.  In Table 1, it states under Publishers and other Information Sources: "online resources featured most frequently with a significantly [sic] impact on participant understanding . . ."    This led me to wonder how the methodology derived what was "significant" and which actors were more significant than the others.  (e.g., see line 500 where Formal Regulators "appear less frequently"). Also, in the text in the methodology section, the focus on AMR is inconsistent, making me question how the interviews were conducted.  Sometimes the data addresses healthcare more generally (e.g., line 338 - addressing a desire for kindness in doctors), and elsewhere it is specific to AMS concerns (e.g., line 429 influence of internet on patient's perceived need for antibiotics). More information is needed on how long the interviews were, whether the questions were structured and consistent, and what those questions were.

Second, in the Analysis section, if no solutions will be offered (see line 202 - no normative focus here) on how to ensure a more patient-centric regulatory scheme amidst a polycentric healthcare environment, then I think more about existing efforts toward AMS solutions needs to be presented.  For example, an obvious non-legal solution may be to evaluate the existing public health information efforts that try to influence patients to self-regulate better.

Below are some more specific suggestions for revision:

1. Abstract and Introduction - needs to more clearly state the jurisdictional focus (Australia and primary care specifically) up front.  For the first two pages, it seemed that it was a global comparative study.

2. More than once it is stated that the polycentric influences "radically alter" prescriber capacity (e.g., line 750, 799), but it would help to explain and develop this more.  It still seemed like prescribers served as the ultimate gatekeeper for antibiotic prescriptions (the "command and control").  The article could use some research support to show that prescribers were influenced by patient pressure.

3. The inductive methodology applied (line 243) is vulnerable to criticism - finding patterns in retrospect without a clear hypothesis is too loose here (line 252 - "to remain open to the unexpected").  The study lacked methodological rigor, but could be valuable as a medical sociological or anthropological review of prescribing practices and patient perspectives if AMS were focused on more clearly throughout.

4. Inclusion of "The Somatic and Emotional Experience of Illness" was not convincing as a regulatory actor, but would be more convincing in a discussion generally as to internal factors in self-regulation by the patient.  

5. The discussion of gender concerns was interesting throughout, but I also wonder how race, ethnicity, age of patient and physician were discussed in the data. These cultural components deserve more attention throughout the health law literature and it seemed that the interview data could offer even more.  The wonderful quotes from patients shared in the article evince a trust that was generated with the interviewer(s) and more would be welcome.

6. In the section on Family and friends as regulatory actors (line 437), I was surprised no mention was made as to the impetus for a patient to seek treatment and antibiotics to protect their loved ones from contagion.  All of these concerns would be heightened during the pandemic, and I was glad to see that it was acknowledged that the study was conducted at this time.  

7. Section on Health System Operators (from line 544) was the strongest of the regulator sections in terms of depth, as well as the section on Work and Employers (line 683). I did wonder whether school policy and school attendance concerns would have a similar effect on families seeking antibiotics. 

8. In the conclusion, there is a mention of justice which needs to be developed more throughout the article, or taken out completely.  (e.g., line 897 "embed an unjust and potentially ineffective over-reliance" targeting prescribers).  This seems to be sympathetic to providers, but there is also an emphasis on patient-centric approaches (line 897). However, yet another change in tone occurred with language that seemed to argue for finding ways to manipulate the patient (line 887 - "to support more effective regulatory responses to AMR by harnessing the interrelation that does exist for the patient"). I think it's legitimate to argue for a more or less patient-centric approach in this public health AMR crisis, but the article needs some more consistency in tone of argument. Perhaps the authors are sympathetic to both health practitioner and patient, but if the argument is that AMR needs to be confronted, then who is the "bad guy"?

I hope these comments are helpful and I particularly appreciated the rich data that came from the interviews.

Author Response

Thank you to Reviewer 2 for their review of this manuscript. Responses to each query and suggestion are made in the attached response document.

 

Author Response File: Author Response.pdf

Round 2

Reviewer 1 Report

Comments and Suggestions for Authors

The edits sufficiently address the feedback provided in my earlier review. 

Reviewer 2 Report

Comments and Suggestions for Authors

Revised submission presents a better framed argument overall.  With substantial revision, restructured organization, and addition of sources and discussion, I found the submission more helpful to the field and more interesting. The expertise of the author is better highlighted here, as well, which will add weight to the published article.

Author should note typos on line 334 (actor); line 413 (strike word "of"), and line 1045 (on should be "one")