The minimal important change (MIC) and minimal clinically important difference (MCID) of the patient and observer scar assessment scale (POSAS) 2.0.

BACKGROUND: The Patient and Observer Scar Assessment Scale (POSAS) is frequently used to assess scar quality after burns. It is important to be aware of the minimal important change (MIC) and the minimal clinically important difference (MCID) to establish if a POSAS score represents a clinically relevant change or difference. The aim of this study is to explore the MIC and MCID of POSAS version 2.0. METHODS: This prospective study included 127 patients with deep dermal burns that underwent split thickness skin grafting with a mean age of 44 years (range 0 - 87) and total body surface area burned of 10 % (range 0.5 - 55). POSAS data was obtained for one burn scar area at three, six, and 12 months after split skin grafting. At the second and third visits, patients rated the degree of clinical change in scar quality in comparison to the previous visit. At 12 months, they completed the POSAS for a second burn scar area and rated the degree of clinical difference between the two scar areas. Two anchor-based methods were used to determine the MIC and MCID. RESULTS: MIC values of the patient POSAS ranged from - 0.59 to - 0.29 between three and six months and from - 0.75 to - 0.38 between six and 12 months follow-up. Both had a poor discriminatory value. MCID values ranged from - 0.39 and - 0.08, with a better discriminatory value. CONCLUSION: Results suggest that patients consider minor differences (less than 0.75 on the 1-10 scale) in POSAS scores as clinically important scar quality changes. MCID values can be used to evaluate the effects of burn treatment and perform sample-size calculations.

Validity of thermography for measuring burn wound healing potential.

Accurate assessment of burn wound depth and the associated healing potential is vital in determining the need for surgical treatment in burns. Infrared thermography measures the temperature of the burn wound noninvasively, thereby providing indirect information on its blood flow. Previous research demonstrated that a small, low-priced, handheld thermal imager has an excellent reliability, but a moderate validity for measuring burn wound healing potential. A new and more sensitive version of this convenient device has become available. The aim of this study was to evaluate the validity of thermography for measuring burn wound healing potential, compared to Laser Doppler Imaging (LDI) as a reference standard. Thermal images and LDI scans were obtained from burn wounds between 2 and 5 days postburn. Temperature differences between burned and nonburned skin (ΔT) were calculated. To evaluate validity, ΔT values were compared to the healing potential categories assessed by LDI. Two receiver operating characteristic curves were created and two ΔT cutoff values were calculated to illustrate the ability to discriminate between burn wounds that heal in a time period of less than 14 days, between 14 and 21 days, and more than 21 days. Between June and October 2018, 43 burn wounds in 32 patients were measured. ΔT cutoff values of 0.6°C (sensitivity 68%, specificity 95%) and -2.3°C (sensitivity 30%, specificity 95%) were calculated to discriminate between burn wounds that heal in <14 and ≥14 days, and burn wound that heal in ≤21 and >21 days, respectively. This study shows a good validity of the feasible thermal imager for the assessment of burn wound healing potential. Therefore, we consider it a promising technique to be used for triage in local hospitals and general practices, and as a valuable addition to clinical evaluation in burn centers.

Systematic Review on the Content of Outcome Measurement Instruments on Scar Quality.

Measurements of scar quality are essential to evaluate the effectiveness of scar treatments and to monitor scars. A large number of scar scales and measurement devices have been developed, which makes instrument selection challenging. The aim of this study was to provide an overview of the content (ie, included items) of all outcome measurement instruments that measure scar quality in different types of scars (burn, surgical, keloid, and necrotizing fasciitis), and the frequency at which the instruments and included items are used. METHODS: A systematic search was performed in PubMed and Embase.com up to October 31, 2018. All original studies reporting on instruments that measured at least 1 characteristic of scar quality were included and the instrument's content was extracted. RESULTS: We included 440 studies for data extraction. Included instruments (N = 909) were clinician-reported scales (41%), measurement devices (30%), patient-reported scales (26%), and combined clinician- and patient-reported scales (3%). The Observer scale of the Patient and Observer Scar Assessment Scale, the Cutometer, the Patient Scale of the Patient and Observer Scar Assessment Scale, and the modified Vancouver Scar Scale were the most often used instrument in each of these categories, respectively. The most frequent assessed items were thickness, vascularity, pigmentation, pliability, pain, and itch. CONCLUSION: The results of this study lay the foundation for our future research, which includes an international Delphi study among many scar experts, and an international focus group study among scar patients, aiming to elucidate how scar quality must be defined and measured from both professional and patient perspectives.

Surgical innovation: the ethical agenda: A systematic review.

The aim of the present article was to systematically review the ethics of surgical innovation and introduce the components of the learning health care system to guide future research and debate on surgical innovation.Although the call for evidence-based practice in surgery is increasingly high on the agenda, most surgeons feel that the format of the randomized controlled trial is not suitable for surgery. Innovation in surgery has aspects of, but should be distinguished from both research and clinical care and raises its own ethical challenges.To answer the question "What are the main ethical aspects of surgical innovation?", we systematically searched PubMed and Embase. Papers expressing an opinion, point of view, or position were included, that is, normative ethical papers.We included 59 studies discussing ethical aspects of surgical innovation. These studies discussed 4 major themes: oversight, informed consent, learning curve, and vulnerable patient groups. Although all papers addressed the ethical challenges raised by surgical innovation, surgeons hold no uniform view of surgical innovation, and there is no agreement on the distinction between innovation and research. Even though most agree to some sort of oversight, they offer different alternatives ranging from the formation of new surgical innovation committees to establishing national registries. Most agree that informed consent is necessary for innovative procedures and that surgeons should be adequately trained to assure their competence to tackle the learning curve problem. All papers agree that in case of vulnerable patients, alternatives must be found for the informed consent procedure.We suggest that the concept of the learning health care system might provide guidance for thinking about surgical innovation. The underlying rationale of the learning health care system is to improve the quality of health care by embedding research within clinical care. Two aspects of a learning health care system might particularly enrich the necessary future discussion on surgical innovation: integration of research and practice and a moral emphasis on "learning activities." Future research should evaluate whether the learning health care system and its adjacent moral framework provides ethical guidance for evidence-based surgery.