Somatology Practices in Non-medical Aesthetic Treatments: Towards Development of Good Practice Guidelines for Somatology in South Africa: a Scoping Review Protocol

Background: The medical aesthetics industry is a very pro�table and rapidly growing branch of medicine. Currently, somatologists or beauty therapists who either independently perform or assist medical directors in these aesthetic procedures, are not regulated by a professional body in most countries including South Africa. The absence of a prescribed scope of practice, attributed to absence of formal professional regulation, has resulted in an increase in anecdotal reports of complications and malpractice being referred to medical professionals. Since the mandate of regulatory bodies is to guide the professions and to protect patients and the public, currently, the absence of regulation in the somatology profession exposes patients/clients to unsafe practices predominately in the private sector. The objective of this scoping review is to map evidence on the somatology practices and regulations for non-medical aesthetic treatments. Methods: We will conduct a scoping review using peer reviewed journal articles that present literature on the practice of non-medical aesthetic treatments. Grey literature including media reports, and unpublished theses will be included. Electronic searches of databases and search engines such as Scopus, CINAHL, EBSCOhost, Health Source - Consumer Edition; Health Source: Nursing/Academic Edition, Open Dissertations, Google Scholar and MEDLINE will be undertaken to attain published articles and reports from all study designs. Duplicated documents will be deleted prior to title screening commencing. All retrieved literature will be exported into an Endnote X20 library. The quality of each publication will be appraised using the mixed methods appraisal tool (MMAT) – version 2018. Discussion: We will map the evidence of how non-medical treatments are commonly being performed by non-physicians and somatologists, including identifying which treatments and procedures are more at risk in resulting in adverse reactions if not administered ethically or correctly. Once summarised, the data could be used to develop relevant and current good practice guidelines that could be later integrated into a framework for somatologists performing non-medical aesthetics treatments in South Africa.

Dissertations, Google Scholar and MEDLINE will be undertaken to attain published articles and reports from all study designs. Duplicated documents will be deleted prior to title screening commencing. All retrieved literature will be exported into an Endnote X20 library. The quality of each publication will be appraised using the mixed methods appraisal tool (MMAT) -version 2018.
Discussion: We will map the evidence of how non-medical treatments are commonly being performed by non-physicians and somatologists, including identifying which treatments and procedures are more at risk in resulting in adverse reactions if not administered ethically or correctly. Once summarised, the data could be used to develop relevant and current good practice guidelines that could be later integrated into a framework for somatologists performing non-medical aesthetics treatments in South Africa.
Systematic review registration: Open Science Framework registration (https://osf.io/4fk8g/) Background Countries such as the United States of America and Netherlands have regulated the beauty industry (1). In these countries therapists are required to acquire a cosmetology license to practice or for insurance purposes (2,3). However, within the South African context, the Somatology industry has no clear scope of practice and is not regulated by a professional body, such as either the Health Professions Council of South Africa (HPCSA) or Allied Health Professional Council (AHPCSA) (4,5). This vacuum in legislation may have led to an increase in numerous somatologists performing more specialised non-medical aesthetic treatments independently, or under supervision of a medical professional, for lucrative economic gain without either adequate training or supervision (4,6). This is in contravention with both the Health Professions Act 56 of 1974 (section 39/A) and the Allied Health Professions Act 63 of 1982 which speci cally prohibits health professionals registered under the speci c act from working directly with any other unregistered professional (7). Both professional boards also prescribe such activity as an offence punishable by either a ne or imprisonment. The medical industry is experiencing an increase in the referral of patients with complications following from medical aesthetic treatments performed by unregistered somatologists, both internationally and locally (8-12).
The medical aesthetics industry is a very pro table and rapidly growing branch of medicine both internationally and locally (13)(14)(15)(16)(17). Reports (10,(18)(19)(20) emerging from international countries that have regulated the practice of somatologists are highlighting the dangers and increase in litigation associated with these practitioners. This is prevalent despite the fact that on-site medical directors were consulted or supervised the procedures. When there is no professional regulation, some health care professionals may deliver low-quality services at high-quality prices to unaware consumers (1,21). This concept may be adapted to somatologists, who may or may not be employed by other registered health care professionals, to perform specialized time-consuming treatments at generally high prices (22). More especially, when the legal nuances are not clearly understood, it may result in some medical professionals willfully or inadvertently not being compliant with legislation. With regulation, the profession can provide axillary support to other health professionals and become members of a multidisciplinary team approach, as proposed in the National Health Insurance (NHI) (23). Thus, establishing partnerships with the Department of Health, the Sustainable Development Goal (SDG) 3 of the United Nations Development Programme, which addresses good health and well-being for all (United Nations Development Programme, 2021)(24) can be more obtainable.
Recently the training for somatologists has become more extensive, enabling the therapists to analyse and treat skin and body conditions through various specialised non-medical treatments (25). Thus, more are working in medical settings (Medical spas, Medical Aesthetic practices) alongside doctors specialising in cosmetic surgical and/or non-surgical procedures(6, 9,25). The aim of the study is to map evidence on the somatology regulations for non-medical aesthetic treatments. This study seeks to draw from the understandings of both medical aesthetics professionals and somatologists to identify gaps that could be addressed and used to develop relevant and current good practice guidelines that could be later integrated into a framework for somatologists performing non-medical aesthetics treatments in South Africa. Additionally, it is anticipated that these guidelines will assist in strengthening this fastevolving profession while safeguarding the equilibrium between patient safety and pro tability.

Methodology
To e ciently map an extensive range of information on the existing practice of somatology in nonmedical aesthetic treatments, a scoping review was selected. A phenomenological approach to systematically and rigorously map published literature, including identifying gaps on this topic from quantitative, qualitative and mixed-methods studies. The protocol is guided by Arksey and O'Malley's rst ve stages of the methodological framework for conducting a scoping review(26). The framework was ampli ed by Levac et al. (27). This involved, the identi cation of the research question, identi cation of appropriate studies, the study selection, charting the data, including collating, summarizing and reporting of the search results. As per the appraisal tools of the Joanna Briggs Institute(28) the quality of the articles and records will also be appraised. This scoping review protocol was registered on OSF (Open Science Framework) apriori and it is accessible via this link: https://osf.io/4fk8g/

Identi cation and eligibility of the research question
Research question is as follows: What is known about the somatology practices in non-medical aesthetic treatments?
The Population, Context, Concept (PCC) framework will su ciently explain the eligibility of the research question (Table 1). organizations' reports such as those of the WHO, will be included in the search.
A pilot search with EBSCOhost using selected databases (Business Source Complete; Academic Search Complete; AHFS Consumer Medication Information; CINAHL Complete; Health Source -Consumer Edition; Health Source: Nursing/Academic Edition; MasterFILE Premier; MEDLINE; OpenDissertations) was conducted to demonstrate feasibility of addressing the research question using a scoping review method. University of Pretoria (KG) and Durban University of Technology (AF) librarians assisted in optimizing the search strategy. Presented in Table 2 are the results of the pilot search. (Somatology OR somatologist OR "beauty therapist" OR aesthetician OR cosmetologist OR spa OR "beauty salon" OR beautician OR "skin care therapist" OR "Beauty Technologist" OR "non-physician operator" ) AND ( "nonmedical aesthetic treatments" OR "non-invasive beauty treatment" OR "aesthetic treatments" OR "beauty procedures" OR "skin resurfacing cosmetic treatment" OR "Intense pulse light (IPL)" OR "Photodynamic therapy" OR "Microdermabrasion" OR Microplaning OR Microblading OR "Radio Frequency skin treatment" OR "Chemical skin peels" OR "skin care" OR "Skin rejuvenation" Or "Wound healing" ) AND ( "practice guidelines" OR "ethical issues" OR "scope of practice" OR guideline OR policy OR complain OR "professional practice No restrictions on the publication period or geographical origin of the articles or records will be included as part of the research methodology as the introduction and concept of non-medical aesthetic treatments are relatively young. Thus, providing a broader overview of how the discipline has morphed into its current practice and the factors associated with such practice.

Study selection
To ensure that relevant studies were included on how non-medical aesthetics is currently practised, a selection criterion was developed. Two members of the research team independently screened against the prede ned inclusion criteria to determine eligibility. Any discrepancies will be resolved through dialogue between the two reviewers; but if no consensus is reached then a third reviewer will be consulted.

Inclusion criteria
To be included, articles or records must meet the following criteria: Reporting evidence on medical aesthetic treatments currently being practised Reporting evidence on various non-medical aesthetic treatments Reporting evidence on who is performing the non-medical aesthetic treatments Reporting evidence on the ethical practice of the medical aesthetic industry Reporting evidence on scope of practice of somatologists/non-physician operators

Exclusion criteria
We will exclude articles guided by the following exclusion criteria: Articles reporting evidence on cosmetic surgery treatments only performed by medical professionals.
The review will be conducted within a two-month time frame (October to November 2021). The quantity of publications reviewed including full-text studies retrieved, records and articles and records that have been excluded will be reported on using guidelines and criteria established in Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping Reviews (PRISMA ScR) (Figure 1).
Charting the data A data charting template was constructed using the Google form software to extract and record relevant data characteristics from included articles and other sources of evidence ( Table 3). The data will be independently charted and transferred from the articles and records onto the form. The charting form will be piloted by two of the screeners. An additional screener will independently endorse appropriateness for the article's inclusion. After charting ten articles, all the screeners involved will meet to establish if the process is effective and all variables satisfy the requirements of the review. The data will be compared and any differences will be resolved either by consensus or third reviewer. The PRISMA ScR will be updated continuously throughout this process. Table 3 Data charting form Page 7/12 Collating, summarizing, and reporting of the results As a variety of study designs and records are included in the scoping review, the Mixed Method Appraisal Tool (MMAT)-version 18 (30) will be used to evaluate the quality of the included evidence. The process comprises of a three stages approach. Stage 1 includes thematic content analysis for qualitative studies and numerical counts and tables for quantitative studies. Stage 2 involves a narrative report and summary of the results. Stage 3 will highlight the literature gaps identi ed pertaining to the practice of non-medical aesthetics. In addition, practicability of conducting further systematic review or studies will be suggested, which may contribute to addressing the literature gaps identi ed.
Therefore, the themes identi ed would be examined in relation to the objectives of the study to map evidence on the current somatology practice and regulations for non-medical aesthetic treatments. To develop relevant and current good practice guidelines that could be later integrated into a framework for somatologists performing non-medical aesthetics treatments in South Africa.

Discussion
To the best of our knowledge, this proposed scoping review will be one of the rst in the somatology eld to contemplate mapping evidence on the Somatology practices in non-medical aesthetic treatments. As the somatology profession is fast-evolving, driven by high pro t potential and not regulated by a statutory professional body, patient safety could be compromised. The World Health Organization (WHO) vision is to ensure good health and well-being for all (SDG3) and the South African Association of Health and Skincare professionals objective is to increase professionalism and enhance consumer protection against improper practice (25). Thus the ndings can make a valuable contribution to identifying the gaps in the current somatology practice.
Despite there being strong evidence of how medical aesthetics is currently practised within the medical professional relating to medical aesthetic surgery, these surgical procedures have been excluded from this scoping study as surgery is not within a somatologist scope of practice.
It is anticipated that the results emanating from this study will identify which treatments and procedures are more perilous in resulting in adverse reactions if not administered correctly. Such ndings could be bene cial in developing good practice guidelines that could be later integrated into a framework for somatologists performing non-medical aesthetics treatments in South Africa. Additionally, it is anticipated that these guidelines will assist in safeguarding the equilibrium between patient safety and pro tability.

Limitations
Conducting a scoping review with no time limitation may prove time consuming and expensive. Thus, to ensure the process is cost-effective and timeously completed strict timelines will be applied. Any client complications or damages caused through medical aesthetic surgery performed speci cally by medical professionals will not be included. Declarations Figure 1 PRISMA ScR ow diagram demonstrates the literature searches including the selection of evidence processes (29) *Consider, if feasible to do so, reporting the number of records identi ed from each database or register searched (rather than the total number across all databases/registers).