The methodology for developing this guideline followed eight overarching methodological steps that aligned with best practice principles for adapting suitable international source guidelines as recommended by the NHMRC Guidelines for Guidelines  and the ADAPTE and GRADE-ADOLOPMENT frameworks [17, 18]. The eight overarching steps and our approach to implementing these steps are detailed below. In summary the steps were: i) defining the scope of the guidelines; ii) identifying potential international source guidelines; iii) determining suitable international source guidelines to adapt; iv) deciding which recommendations to adopt, adapt, or exclude; v) drafting recommendations and the reasoning for those recommendations; vi) developing guideline manuscripts; vii) external consultation and approval of guideline manuscripts; and viii) developing clinical pathways to aid implementation into practice.
Defining the scope of the guidelines
The scope of these guidelines were defined using the PIPOH (spelt out below) framework recommended by ADAPTE  and based on (inter)national DFD reporting standards [1, 5, 6, 19], i.e.:
Population(s) of interest - were those defined as at risk of, or with, DFD [5, 6];
Intervention(s) of interest - were those interventions typically used to screen, diagnose, prevent, or treat the population(s) of interest [5, 6];
Professions to be targeted - were those multiple medical, surgical, nursing and allied health disciplines that typically provide prevention or treatment for the population(s) of interest [1, 19, 20];
Outcomes of interest - were those outcome measures typically used for the population(s) of interest, such as ulcer healing or amputation [5, 6];
Health care context to be targeted - were those secondary and/or tertiary health care settings and organisations that typically provide prevention or treatment for the population(s) of interest in Australia [1, 19, 20].
Identifying potential international source guidelines
Based on the above defined scope we performed a systematic search for potentially suitable international source guidelines [13, 17]. The search strategy included any guideline record published until 1 May 2020, in the International Guidelines Library  or Australian Clinical Practice Guidelines Register databases . These guideline databases were chosen as they were specifically recommended for this purpose by either NHMRC  or ADAPTE . We used the following free text search terms in these databases: “diabetes”, “foot”, “feet”, “wound” or “ulcer”. All authors were also asked to identify any other potentially suitable guideline records of which they were aware, and these were included in the search strategy as additional records identified via other sources.
The title and abstract (if available) of each unique record identified from the search strategy was independently screened by three authors (PAL, AR, JP) for eligibility for full-text assessment. The inclusion criteria were those records: i) with the primary aim of developing clinical guidelines to prevent or manage people with, or at risk of, DFD; ii) developed for an international multi-disciplinary health professional audience; iii) written in English (the national language of Australia); iv) based on systematic review(s) of the available literature; and v) which incorporated a final systematic review search date within 3 years of our search date (i.e. 1 May 2017) for currency. All records screened as eligible by any of the three authors were included for full text assessment.
Each guideline record identified as eligible after screening then had their full text retrieved and assessed based on the same above inclusion criteria by two authors independently (PAL, AR, or JP) . Any disagreements on eligibility by the two authors were discussed until consensus was reached or if unable to be reached a third author decided . Decisions to exclude any full-text records were recorded identifying the criteria the guideline record failed to meet [17, 22].
Determining suitable international source guidelines to adapt
Remaining eligible full text records were then independently assessed by four authors (PAL, AR, JP, RJC) for their methodological quality, suitability and currency to be adopted or adapted to the Australian health context [13, 17]. The Appraisal of Guidelines for Research and Evaluation II (AGREE II) Instrument was used to assess methodological quality [17, 23, 24]. The AGREE II instrument is a widely used, valid and reliable 23-item instrument, each using a 7-point Likert scale, for assessing methodological quality of guidelines [23, 24]. The scores of the four authors were summed and divided by the maximum possible score to determine a total score % . Scores were categorised: high quality if scored > 70%, moderate if 50–69%, and low if < 50% [17, 23, 24].
A customised tool from NHMRC was used to assess suitability and currency . The tool is a 22-item tool developed by the authors using the exact questions outlined in the NHMRC Guidelines for Guidelines table of factors that should be considered for assessing the suitability and currency of a guideline to adopt or adapt in the Australian context  (Supplementary Material Table S1). The tool included 21 items using a 7-point Likert scale to determine suitability, and, one open item using the final literature search date of the guideline record to determine currency. Total scores for suitability were determined using the same formula used for the AGREE II tool [23, 24] and categorised: high suitability if scored > 70%, moderate if 50–69%, and low if < 50%. Currency was defined as the total time elapsed between the final literature search date of the guideline record and the search strategy date of this protocol (i.e. 1 May 2020), and categorised: high currency if < 1 year since final search date, moderate currency if < 3 years, and low currency if > 3 years [13, 17].
All documents that informed the development of each eligible full text guideline record were included as part of these assessments, including any systematic reviews, methodology protocols and technical reports [13, 17]. Any record deemed as having at least moderate quality, moderate suitability and moderate currency following these assessments was defined and included as a suitable international source guideline to adopt or adapt to the Australian health context for this project [13, 17].
Deciding which recommendations to adopt, adapt or exclude
All recommendations within the above suitable international source guidelines were individually extracted and evaluated to determine if they should be adopted, adapted, or excluded in the Australian context [13, 17, 18]. The following five sub-steps were followed: a) recommendations were categorised into six sub-fields; b) national expert panels were convened for each sub-field; c) panels screened all recommendations in their sub-field; d) panels assessed any recommendations if unsure of acceptability or applicability; and e) panels decided which recommendations to adopt, adapt or exclude [13, 17, 18].
Recommendations were categorised into six sub-fields
Two authors (PAL, AR) independently categorised all recommendations (and the relevant clinical questions they addressed) from all included suitable source guidelines into one of six DFD sub-fields that the authors considered the recommendation was primarily addressing [5, 6]. The six sub-fields aligned with international DFD standards and included: prevention, wound classification, peripheral artery disease (PAD), infection, offloading, and wound healing interventions [5, 6]. The two authors discussed any disagreements until consensus was reached or if this was unable to be reached then a third author decided .
National expert panels were convened for each sub-field
All recommendation(s) (and all relevant documentation of reasoning informing the recommendation(s), including rationale, summary(s) of evidence, evidence statements, quality of evidence summaries, risk of bias tables, evidence tables), were forwarded to the relevant sub-field national expert panel to screen. Each national expert panel comprised 6–8 members and was chaired by an author with relevant (inter)national research and/or clinical practice expertise in the sub-field. Panel membership included 4–6 members with either (inter)national research and/or clinical practice sub-field expertise from different disciplines, states (or territories) and genders, plus, a consumer and an Aboriginal and Torres Strait Islander representative with expertise in DFD. An (inter)national research expert was defined as having published in peer-reviewed journals and/or been ranked as an Australian expert in the sub-field according to Expertscape . An (inter)national clinical practice expert was defined as having presented at an (inter)national conference and/or been a member of an (inter)national committee in the sub-field.
Panels screened all recommendations in their sub-field
At least two panel members independently screened each recommendation (and all relevant documentation informing the recommendation) in their sub-field for acceptability and applicability in the Australian health context, using a customised ADAPTE evaluation form (Supplementary Material Fig. S1) . The ADAPTE form comprised 7-items, each using a 3-point Likert scale (yes, unsure, or no), organised into the domains of acceptability and applicability . Acceptability items included screening the quality of evidence, strength of recommendation and user (patients and providers in the context) values ratings for the recommendation to determine if the panel agreed with the included guideline’s original ratings . Applicability items included screening the applicability to patients, availability of equipment and expertise, and any legislative or policy constraints for the recommendation in the Australian health context . The Australian health context was defined as individual patients with, or at risk of, DFD, attending the multiple health professional disciplines that typically provide prevention or treatment services in the secondary and tertiary Australian health care settings that house those services [1, 19, 20]. Any disagreements on item scores were discussed by the two members until consensus was reached, or if it could not be reached, a third member decided . All panel members then met to discuss and decide by consensus all ratings for each item in each recommendation. All recommendations that scored “yes” agreement in all items were able to be adopted for the Australian context. Any recommendations scoring any items as “unsure” or “no” agreement in one or more items required full assessment.
Panels assessed any recommendations if unsure of acceptability or applicability
All recommendations requiring full assessment were done so using a customised Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision (EtD) template (Supplementary Material Fig. S2) [18, 26, 27]. This involved one panel member systematically extracting and populating the template verbatim with all relevant text relating to the rationale for that recommendation from the source guideline for eight important EtD criteria: the problem, desirable effects, undesirable effects, quality of evidence, values, balance of effects, acceptability and feasibility [18, 26, 27]. The same member also added any additional relevant Australian considerations to each of the eight criteria that they considered necessary to inform the Australian context from relevant literature and/or their expert opinion. The populated EtD was checked for accuracy by another member and any disagreements discussed between the two members until agreement was reached. Based on the populated EtD, one panel member rated the detailed and summary judgement items in each of the eight important EtD criteria [18, 26, 27]. Another member checked all judgements made by the first member with any disagreements discussed until consensus was reached . All panel members then met to discuss and decide by consensus all summary judgement item ratings for each of the eight important EtD criteria for each recommendation. Finally, the panel compared the level of agreement between their eight EtD summary judgement items with the source guideline’s summary judgement items (if able to be determined) to determine the level of agreement for each item as: yes (agreed), unsure, or no (disagreed) .
Panels decided which recommendations to adopt, adapt or exclude
The decision to adopt, adapt, or exclude each recommendation was made based on the level of agreement between the panel’s consensus summary judgement items and that of the source guideline’s summary judgement items for each EtD item in each recommendation . This was performed via discussion and a consensus decision by all panel members after reviewing their completed ADAPTE form and/or GRADE EtD summary judgement items for each recommendation [17, 18]. A decision to adopt was made if all items in the customised ADAPTE form scored “yes (agreed)” and/or the panel’s GRADE EtD summary judgement items generally agreed with the source guideline’s summary judgement items . A decision to adapt was made if the ADAPTE form scored an “unsure” or “no” on any item, and there was disagreement between the panel’s GRADE EtD summary judgement items and that of the source guideline’s summary judgement items . A decision to exclude was made if the ADAPTE form scored an “unsure” or “no” on any item, there were substantial disagreements between the panel’s GRADE EtD summary judgement items and that of source guideline’s, and/or the panel considered the recommendation was not acceptable or applicable to use in the Australian context.
Drafting recommendations and reasoning for those recommendations
All recommendations and supporting reasoning for the recommendations were then drafted via consensus by each panel. Depending on the panel’s decision to adopt, adapt or exclude the source guideline’s recommendation shaped how the panel drafted each recommendation . When adopting a recommendation, the panel re-stated the source guideline’s recommendation verbatim (including the quality of evidence and strength of recommendation) . Minor wording changes were only permitted if the panel felt exchanging an Australian term for an international term was necessary to improve the interpretation of the recommendation without changing the concept. When adapting a recommendation, the panel drafted the recommendation based on the source guideline’s recommendation and adapted/edited the recommendation’s wording to reflect the panel’s specific difference in judgement(s) to that of the source guideline’s judgements . As recommended by GRADE the panel drafted each adapted recommendation with the aim of being clear, specific and unambiguous on what is recommended, for which persons, and under what circumstances [18, 26,27,28,29,30]. Further, the panel by consensus, re-evaluated the quality of evidence using the GRADE system as High, Moderate, Low, or Very Low, based on the panel’s level of confidence that the findings were from studies that reported consistent effects with low risk of bias and further research was unlikely to change that confidence [26, 27]. The panel also rated the strength of recommendation using the GRADE system, based on weighing up the balance of effects, quality of evidence, applicability and feasibility [26, 27] in the Australian health context as: Strong, if there was a large clear difference in the balance of effects (i.e. large net benefit or net harm) between an intervention and control; or Weak, if there was a small and/or uncertain difference [26, 27]. When excluding a recommendation, the panel simply stated the recommendation was excluded.
Regardless of the panel’s decision to adopt, adapt, or exclude the recommendation, the panel drafted transparent reason sections to support their decisions for each recommendation . These sections included: rationale for the decision, justifications for the recommendation, and considerations on implementation, special subgroups, monitoring and future research priorities for the recommendation [18, 26,27,28,29,30]. The rationale for the decision involved the panel documenting why they decided to adopt, adapt, or exclude the recommendation based on the similarities or differences in judgements with those of the source guideline’s judgements. The panel also clearly outlined any wording changes as compared to the source guideline’s original recommendation . The justifications for the recommendation were based on the panel carefully weighing up the panel’s ADAPTE and/or GRADE EtD summary judgements to determine the strength of the recommendation, quality of evidence rating, patient (and provider) values and preferences, and acceptability and feasibility for the Australian health context [18, 26,27,28,29,30]. Additionally, for those recommendations that were adapted or excluded, where applicable the panel also outlined their detailed judgements for each of the eight important GRADE EtD criteria: the problem, values, desirable effects, undesirable effects, balance of effects, quality of evidence, acceptability, and feasibility [18, 26, 27]. Lastly, based on the source guideline’s considerations, literature reviews and expert opinion, the panel outlined any important considerations for health professionals to consider when implementing the recommendations [18, 26,27,28,29,30]. These considerations included: implementing the recommendation in the Australian health context, implementing in special subgroups (including in geographically remote, Aboriginal and Torres Strait Islander, and potentially contraindicated subgroups), monitoring the implementation, and any future research priorities for the recommendation [18, 26,27,28,29,30].
Developing guideline manuscripts
Each panel’s sub-field guideline manuscript was developed using an introduction, methods, results, and discussion framework. The introduction and methods were brief summaries of the introduction and methods contained in this guideline development protocol manuscript, along with any other relevant sub-field literature. The results sections were a collation of all the panel’s consensus recommendations and supporting reasoning (as described in Section v). The discussion sections typically included summaries of the similarities and differences between the new Australian guideline, previous Australian guideline, and the source guideline in terms of recommendations and rationale. The final draft guideline manuscript was approved via consensus of each panel.
Each draft guideline manuscript was then peer-reviewed by at least one author not involved in the sub-field panel, to identify any obvious discrepancies in the recommendations or supporting reasons for the recommendations. If the author(s) identified any discrepancies, the panel was asked to revise the manuscript to consider and address the discrepancy. The agreed final draft of the sub-field guideline manuscript was deemed the consultation draft.
External consultation and approval of guideline manuscripts
The six draft guideline manuscripts used for public consultation (also known as “chapters”), plus this guideline development protocol manuscript, were collated and formatted for consistency ready for public consultation as the new Australian evidence-based guidelines for DFD.. Additionally, a customised public consultation survey based on example surveys from the ADAPTE framework were developed for each guideline to more efficiently gain and collate aggregated feedback from the public consultation process  (Supplementary Material Table S2). Finally, the ADAPTE Checklist for Adapted Guideline Content was completed by the authors to ensure all guideline elements had been completed .
Public consultation was targeted towards Australian health professionals assessing and managing patients with DFD as well as national peak bodies/organisations representing health professionals, consumers or Aboriginal and Torres Strait Islanders. The consultation material included the six guideline manuscripts, the guideline development protocol manuscript and the consultation surveys. Public consultation for each guideline was open for a minimum period of 4 weeks and notification of the consultation period was posted weekly on DFA and/or Australian Diabetes Society (ADS) web and social media sites, plus, invitations were sent electronically to relevant national peak bodies for health professionals, consumers or Aboriginal and Torres Strait Islander people. Any Australian health professional or national peak body with an interest was encouraged to respond.
At the conclusion of the public consultation period all consultation survey responses were collated and analysed. The authors disseminated all aggregated survey findings and feedback comments to the relevant sub-field guideline panels for consideration and revision of their respective manuscripts accordingly. The authors subsequently quality checked each panel’s revisions . Any substantial disagreements with the panel’s revisions were discussed between the authors and the panel concerned until consensus was reached. All aggregated consultation survey findings and each panel’s response to feedback received were publicly displayed on the DFA website. Endorsement of the guidelines were finally specifically sought from DFA, ADS, and Diabetes Australia, plus, invitations to endorse were sent to all aforementioned relevant national peak bodies. All final endorsed guideline manuscripts were publicly published online in full on the DFA website https://www.diabetesfeetaustralia.org/new-guidelines/ [31,32,33,34,35,36], submitted to peer-reviewed journals for publication and registered on the International Guidelines Library  and Australian Clinical Practice Guidelines register .
These new Australian guidelines will be reviewed every 2 years by the authors, or equivalent national guidelines committee, to determine by consensus if any substantial new evidence has been published that contradicts or substantially enhances any existing recommendations. If that is deemed to be the case, or after 4 years (i.e. 2025), whichever comes first, we recommend updating these guidelines using similar adaptation methodology used to develop these new guidelines or develop new guidelines de novo if the requisite funding becomes available.
Developing clinical pathways to aid implementation into practice
To try and facilitate improved implementation into clinical practice, clinical pathways were developed for each guideline that incorporated the recommendations from that guideline. The process used for developing the clinical pathways was that advocated by Flores et al. (2019) . This process included: each panel extracted any clinical pathways from their source guidelines as examples; the guidelines group developed a clinical pathway template based on these example pathways and similar national diabetes clinical pathways; each panel then used the template to develop their clinical pathway(s) by populating the template with their recommendations; and finally, the guidelines group reviewed all the clinical pathways for final quality assurance, formatting and consistency checks .