Development of the consensus-based recommendations for Podiatry care of Neuropathy In Cancer Survivors (PodNICS): a Delphi consensus study of Australian podiatrists

A modified three round Delphi survey was undertaken in line with recommendations for conducting and reporting Delphi studies – CREDES [32]. Delphi methodology involves a panel of experts being anonymously and individually surveyed over a series of iterations (known as Rounds) to gather consensus and agreement on topics that are least explored and lack theoretical frameworks [33, 34]. It has been widely used in different healthcare settings to formulate consensus-based recommendations and guidelines for clinical implementation [35‐37]. This study method also has the benefit of being able to be completed in its entirety online, removing the requirement for people to be geographically available. For this survey, all three rounds were conducted via the online platform Survey Monkey® [38] with the survey links distributed to panellists via email. This study was approved by the University of South Australia’s Human Research Ethics Committee (Protocol number 204307).

Potential panellists in addition to being a registered podiatrist, satisfied at least one of the following criteria to be eligible for the study:

No incentives were offered, and panellists were aware they could withdraw their consent to be involved at any stage. However, to improve the robustness of the outcomes, panellists were asked to commit, and respond independently, for each round.

Round 1 of the survey was purpose-built by members of the authorship group who are clinical and academic podiatrists (SD, HB), with input from authors with experience in cancer-related research (LB, DR). The survey was piloted by three independent external reviewers (two podiatrists and one physiotherapist), with wording and functionality modified based on their feedback. The podiatrists who piloted the questionnaire did not participate further in the study.

In Round 1 (Additional file 1), panellists were asked to complete a short section on their professional experiences (clinical, research and academic) to ensure they met the eligibility criteria. They then provided responses to questions regarding their demographics, opinions and practice habits in relation to CIPN. Demographic questions included gender, age and information regarding their podiatry qualifications. Questions about their experience included years of practice, practice location, average practice hours in primary and secondary positions. In the subsequent sections of the survey, panellists were asked questions regarding:

For this section of Round 1, questions were purposely open-ended to encourage opinion sharing, with one exception where panellists used a five-point Likert scale i.e., strongly disagree, disagree, neutral, agree or strongly agree to identify their confidence with various assessment tools to diagnose CIPN.

Round 2 statements were developed based on the outcomes of Round 1 (as described below). Round 2 also offered panellists the opportunity to add additional opinions and practice habits in relation to the management of clients with CIPN.

Round 3 statements were developed based on the responses to the previous two rounds. No further comments were allowed in this round.

Podiatrists were alerted to the study via passive and active contact methods; passively via personal social media accounts of the authors and national advertising via the Australian Podiatry Association, and actively via targeted emails and invitations sent to the heads of podiatry departments of public health settings and educational institutes for dissemination amongst staff. To minimise location and experience bias, this study aimed to recruit a panel of 25 podiatrists from a variety of settings and locations, specifically aiming for 10 from the public sector, 10 from private and 5 from an academic or research background. Similar sample sizes have been considered adequate and feasible for Delphi surveys and are consistent with other podiatry specific Delphi studies [35, 39, 40]. Podiatrist Registrant Data from 2021 [41] was used to ensure recruitment was geographically balanced to include five panellists from Victoria and New South Wales, three from South Australia, Western Australia, and Queensland, and two from Tasmania, Australian Capital Territory and Northern Territory.

Both panellist eligibility and written informed consent were confirmed at the start of the online survey for Round 1, with skip logic employed to exclude those who did not consent or meet the criteria. Panellists were given four weeks to complete each survey round with reminder emails sent one week prior to the closing date. At the end of each round, all data was downloaded from SurveyMonkey™ into Microsoft Excel (Microsoft Corp, Redmond Washington) for analysis. All three rounds of the Delphi were conducted between April and September 2022.

Open-ended responses to Round 1 were subjected to inductive quantitative content analysis allowing comments made by panellists to be considered individually and aligned into statements [42, 43]. During this review process comments were either aligned with an existing theme or generated into a new theme, with previously reviewed comments able to be re-coded as themes emerged. To minimise bias, analysis was independently conducted by two authors (SD and HB) with any conflicts resolved by discussion. All emergent themes were then converted into a series of statements for circulation in further rounds.

The a-priori decision was to set the level of consensus and agreement at 70%. Therefore, for a statement to be accepted as a consensus, ≥ 70% of panellists were required to make the same ‘themed statement’ in response to an open-ended question (available in Round 1 and 2 only). For a statement to be accepted as reaching agreement, ≥ 70% of panellists were required to indicate they agreed or strongly agreed to that statement on a five-point Likert scale. Statements that reached between 50 and 69% consensus or agreement were retained for further consideration in the subsequent rounds (where available) to allow responders to reconsider them in light of group responses. Statements with less than 50% agreement in Round 1 and 2 and less than 70% agreement in Round 3 were excluded. This method of statement theming and the levels of consensus and agreement are consistent with similar Delphi studies [39, 40, 44].

Outcomes of each round were reviewed by the full authorship team. Collated outcomes from group responses in previous rounds were presented to the panellists within the subsequent round, where available. The number of panellists that had identified or agreed with statements in each round are provided in the supplement (Additional file 2).

The final accepted statements were organised to align with the SOAP (Subjective, Objective, Assessment and Plan) format which is not only useful in documenting clinical findings but also serves as a cognitive framework for clinical reasoning to assess, diagnose and treat a patient in health care settings [45]. Podiatry care of Neuropathy In Cancer Survivors (PodNICS) was developed by the clinical podiatrists within the research team (SD and HB) from the final accepted statements as clinical recommendations to guide the care of clients with CIPN seeking podiatry services.

Usability has been identified as a desirable factor of clinical decision support systems that include guidance on diagnosis and treatment of chronic conditions [46]. To this end, the PodNICS was reviewed by four independent podiatrists for its structure, functionality and to ensure it well-incorporated all accepted statements from the three rounds.

All authors also checked the final recommendations for ease of use and implications in the clinical practice.

Twenty-six out of 76 invited podiatrists consented to participate, met the eligibility criteria, and were enrolled into the study. Twenty-one of those recruited completed Round 1, (four males and 17 females with the mean age of 43.8 years). The geographical representation of the panellists did not meet the planned distribution; however, each State and Territory was represented by at least one participating podiatrist. The mean podiatry experience among panellists was 19 (± 8) years, and all had worked within a high-risk foot clinic for five years or more or chronic disease focused private setting for 10 years or more. Table 1 outlines panellist’s characteristics in detail.

Fifteen of the 21 panellists (71%) reported they had seen clients with CIPN in the last year, with around 33% of them seeing more than five clients in the three months prior to completing the survey. The most common referral source for CIPN clients was their general practitioner (65%), with other referral sources including self-referral (35%), oncologists (29%), alternative allied health or exercise professionals e.g., physiotherapist, exercise physiologist, speech pathologist etc. (29%), and nurse practitioners (18%). Referrals from My Aged Care, hospital outpatients and neurologists were also identified once each (6% respectively) (Table 2).

With respect to common funding sources for the provision of podiatry services, 60% of responders identified their clients as being publicly funded (e.g., attending a hospital or community-based practice). Chronic disease management plan (CDMP) Medicare funding was the second most common source (25%) followed by private health funding (10%) and Commonwealth home support program and home care package (5%) (Table 2).

There were mixed reports of how often clients presented with an existing CIPN diagnosis versus a diagnosis made by the responder. Eight podiatrists indicated that more than 80% of their clients with CIPN presented with an existing diagnosis made by other professionals like neurologists and GPs. However, five respondents reported less than 10% of clients having an existing diagnosis of CIPN. Half of the panellists indicated that they had diagnosed one or more clients with CIPN within the last year who were unaware of their diagnosis.

When asked about their choice of management rationale (in the absence of guidelines) for podiatry management of CIPN, eight common themes were identified from 25 statements by 17 podiatrists (Table 2). The most common rationale identified was clinical experience and previous success from management (47%) followed by knowledge crossover from managing diabetes related foot concerns (23%) and learnt skills from other experienced podiatrists (23%).

Figure 1 outlines the process of Delphi rounds and the respective outcomes.

Round 1 resulted in 229 comments on the open-ended questions that were themed into 53 statements. Of these, 11 statements reached consensus (Table 3) and 42 statements were returned to panellists for consideration on agreement in Round 2 (Additional file 2). No statements were excluded in Round 1.

Statements accepted for consensus included one in relation to Clinical factors and presentation of people with CIPN, nine statements in relation to Diagnosis and Assessment of CIPN, and one statement regarding Podiatry Management of CIPN (Table 3).

Round 2 was completed by 17 panellists, with one panellist withdrawing via email, two failing to respond and one incomplete response received. Round 2 resulted in 22 statements reaching agreement; 12 statements receiving between 50 and 69% agreement requiring further review in Round 3 (Additional file 2); and 20 statements being excluded for not reaching 50% or more agreement (Additional file 2). A further 18 new comments were received that were themed into 15 new statements for Round 3 (Additional file 2).

Of the statements reaching agreement, six related to the clinical factors and presentation of people with CIPN, eight statements were in regarding to diagnosis and assessment of CIPN, and eight statements related to podiatry management of CIPN.

One further panellist failed to complete Round 3 (n = 16). Round 3 resulted in 11 statements reaching agreement and 16 statements being excluded for not reaching 70% or more agreement (Additional file 2). Of the statements reaching agreement, two related to the clinical factors and presentation of people with CIPN, three statements related to the diagnosis and assessment of CIPN, and six statements related to podiatry management of CIPN.

Table 3 outlines all the statements reaching consensus and agreement from all three rounds of the Delphi. With respect to the presentation of CIPN, the Delphi panel identified the presence of sensory symptoms such as neuralgia, paresthesias and allodynia (95% consensus). Other common presenting symptoms identified by the panel were autonomic changes such as changes in temperature regulation leading to cold feet/Raynaud’s phenomenon. Disruption of physical activity and engagement caused by reduced patients’ confidence was also agreed as one of the presentations for people with CIPN.

The objective assessment tools to diagnose CIPN agreed by the panel included monofilament for LOPS (89% consensus); tuning fork (78% consensus), biothesiometer (76% agreement) and nerve conduction study if required for loss of proprioception (82% agreement); deep tendon reflexes (81% agreement), joint range of motion (ROM) and muscle strength assessment (71% agreement).

The panel agreed on the importance of tailoring management according to the severity of CIPN and identified various aspects of patient care. Agreement on management practices not only included management of problems specific to the lower limb such as skin lesions, pain and footwear but also holistic care of patients through discussions about lifestyle, physical activity and overall pain management. For the management of foot specific problems, the panel agreed on the need to assess the skin integrity for any pre-ulcerative (hyperkeratosis and helomas) and ulcerative lesions (88% agreement) and subsequent podiatry management by offloading and footwear modifications as required (100% agreement). The panel also indicated the importance of patient education including: changes in sensation, skin and nails and their implications for foot health; basic foot care e.g. regular self-check of feet, avoiding bare feet, regular emollient, use of socks and shoes (78% consensus); and noted the need for escalation of care advice when required such as in an instance of infection or ulceration (100% agreement). Regular neurological screens by professionals as podiatrists or neurologists were also advised (78% consensus). Panellists also encouraged discussion with the clients around their overall health and lifestyle with possible recommendations on diet, smoking and alcohol use; ability to participate in Activities of Daily Living (ADLs); overall mobility with possible discussion on use of mobility aids; and their ability to drive a motor vehicle with presence of neuropathy (75–81% agreement). They also recommended that podiatry-specific resources on the management of CIPN be accessible to the clients as a part of their care (75% agreement).

The involvement of a multidisciplinary team in the care of the patient was strongly supported, with ongoing communication with the patient's GP, oncologist and other health care professionals involved in their care (100% agreement). Referrals to other allied health professionals such as physiotherapists, occupational therapists, pain specialists and psychologists as per patient needs were also encouraged (94% agreement).

The Delphi process produced a total of 44 accepted statements which informed the development of the Podiatry care of Neuropathy In Cancer Survivors (PodNICS) as clinical recommendations to guide the care of clients with CIPN seeking podiatry services. Recommendations are organised into four categories: Signs and symptoms of CIPN; Diagnosis and assessment of CIPN; Management strategies of CIPN, and Further considerations.

The review of the draft PodNICS by independent podiatrists confirmed that it incorporated results of the Delphi surveys faithfully and was relevant to clinical practice, with only minor changes recommended for wording of the draft. The final PodNICS incorporating the suggested changes of the external reviewers is shown in Fig. 2.

The Delphi survey methodology, even though a well-known and widely researched methodology, is sometimes criticised due to the quantitative nature of the data being collected and its purposeful sampling methodology [32, 34, 68]. However, with panellists recruited from different geographical locations with the collective clinical experience of 19 years, a broad range of knowledgeable opinions were collected to provide evidence of consistency in podiatry practice. The definition of an ‘expert podiatrist’ is consistent with previous Delphi studies conducted in the field of podiatry [35, 39, 40, 44] and respondents remained anonymous to each other throughout the survey. However, the management options indicated in the recommendations should be used with clinical justification and judgement given the lack of evidence-based research for podiatry management of CIPN.

It would be of benefit to conduct further studies with robust methodology on the effectiveness of various non-pharmacological interventions for management of CIPN. Moreover, encouragement and inclusion of podiatrists in the multidisciplinary care of cancer survivors would be ideal given the key role podiatrists play in the care of people with CIPN-specific lower limb problems.