Development of a value-based healthcare burns core set for adult burn care.

BACKGROUND: Value-based healthcare (VBHC) is increasingly implemented in healthcare worldwide. Transparent measurement of the outcomes most important and relevant to patients is essential in VBHC, which is supported by a core set of most important quality indicators and outcomes. Therefore, the aim of this study was to develop a VBHC-burns core set for adult burn patients. METHODS: A three-round modified national Delphi study, including 44 outcomes and 24 quality indicators, was conducted to reach consensus among Dutch patients, burn care professionals and researchers. Items were rated on a nine-point Likert scale and selected if ≥ 70% in each group considered an item 'important'. Subsequently, instruments quantifying selected outcomes were identified based on a literature review and were chosen in a consensus meeting using recommendations from the Dutch consensus-based standard set and the Dutch Centre of Expertise on Health Disparities. Time assessment points were chosen to reflect the burn care and patient recovery process. Finally, the initial core set was evaluated in practice, leading to the adapted VBHC-burns core set. RESULTS: Twenty-seven patients, 63 burn care professionals and 23 researchers participated. Ten outcomes and four quality indicators were selected in the Delphi study, including the outcomes pain, wound healing, physical activity, self-care, independence, return to work, depression, itching, scar flexibility and return to school. Quality indicators included shared decision-making (SDM), the number of patients receiving aftercare, determination of burn depth, and assessment of active range of motion. After evaluation of its use in clinical practice, the core set included all items except SDM, which are assessed by 9 patient-reported outcome instruments or measured in clinical care. Assessment time points included are at discharge, 2 weeks, 3 months, 12 months after discharge and annually afterwards. CONCLUSION: A VBHC-burns core set was developed, consisting of outcomes and quality indicators that are important to burn patients and burn care professionals. The VBHC-burns core set is now systemically monitored and analysed in Dutch burn care to improve care and patient relevant outcomes. As improving burn care and patient relevant outcomes is important worldwide, the developed VBHC-burns core set could be inspiring for other countries.

Visualizing dynamic three-dimensional changes of human reticular dermal collagen under mechanical strain.

In clinical practice, plastic surgeons are often faced with large skin defects that are difficult to close primarily. Management of large skin wounds e.g. burns or traumatic lacerations requires knowledge of skin biomechanic properties. Research into skin microstructural adaptation to mechanical deformation has only been performed using static regimes due to technical limitations. Here, we combine uniaxial stretch tests with fast second harmonic generation imaging and we apply this for the first time to investigate dynamic collagen rearrangement in reticular human dermis.Ex vivohuman skin from the abdomen and upper thigh was simultaneously uniaxially stretched while either periodically visualizing 3D reorganization, or visualizing 2D changes in real time. We determined collagen alignment via orientation indices and found pronounced variability across samples. Comparing mean orientation indices at the different stages of the stress strain curves (toe, heel, linear) showed a significant increase in collagen alignment during the linear part of the mechanical response. We conclude that fast SHG imaging during uni-axial extension is a promising research tool for future studies on skin biomechanic properties.

From qualitative data to a measurement instrument: A clarification and elaboration of choices made in the development of the Patient Scale of the Patient and Observer Scar Assessment Scale (POSAS) 3.0.

PURPOSE: To clarify and elaborate on the choices that were made in the development of the Patient Scale of the Patient and Observer Scar Assessment Scale 3.0 (POSAS 3.0), based upon the rich information obtained from patients during focus groups and pilot tests. METHODS: The discussions described in this paper are a reflection of the focus group study and pilot tests that were conducted in order to develop the Patient Scale of the POSAS3.0. The focus groups took place in the Netherlands and Australia and included 45 participants. Pilot tests were performed with 15 participants in Australia, the Netherlands, and the United Kingdom. RESULTS: We discussed the selection, wording and merging of 17 included items. Additionally, the reason for exclusion of 23 characteristics are given. CONCLUSION: Based upon the unique and rich material of patient input obtained, two versions of the Patient Scale of the POSAS3.0 were developed: the Generic version, and the Linear scar version. The discussions and decisions taken during the development are informative for a good understanding of the POSAS 3.0 and are indispensable as a background for future translations and cross-cultural adaptations.

A clinimetric assessment of the validity and reliability of 3D technology for scar surface area measurement.

INTRODUCTION: The quality of scars has become an important outcome of burn care. Objective scar assessment through scar surface area measurement enables quantification of scar formation and evaluation of treatment efficacy. 3D technology has proven valid and reliable but often remains cumbersome, expensive, and time-consuming. 3D technology with depth sensors on mobile devices has become available and might surpass these limitations. This study provides a clinimetric assessment of the validity and reliability of a 3D system with a depth sensor for scar surface area measurement. METHODS: A technology involving a depth sensor mounted on a mobile device was used. Images and analyses were made with a custom-made software application. A standardized one-keyframe image capturing procedure was followed. To assess validity, stickers with predefined dimensions (8.01 cm2 - 77.70 cm2) were imaged in a single observer setting on various body parts of healthy volunteers. To assess reliability, hypertrophic scars, keloids, and normotrophic scars were imaged and rated by two observers independently. Data are expressed as mean (+/-SD), Coefficient of Variation (CV), Intraclass Correlation Coefficients (ICC), and Limits of Agreements (LoA). RESULTS: Eighty stickers placed on 20 healthy volunteers showed validity with CV between 0.62%- 1.67% for observer A and 0.75%- 1.19% for observer B. For the reliability study, 69 scars on 36 patients were included. Mean scar surface area ranged from 0.83 cm2 to 155.59 cm2. Mean scar surface area measurement was 13.83 cm2 (SD 23.06) for observer A and 13.59 cm2 (SD 23.31) for observer B. Adjusted interobserver CV for trained observers is estimated as 5.59%, with corresponding LoA = 0 ± 0.15 x mean surface area. Interobserver ICCs were 0.99-1.00. CONCLUSION: This 3D technology with a depth sensor for measuring scar surface area provides valid and reliable data and thereby surpasses expensive and time-consuming 3D cameras.

Development of the Patient Scale of the Patient and Observer Scar Assessment Scale (POSAS) 3.0: a qualitative study.

PURPOSE: The Patient and Observer Scar Assessment Scale (POSAS) is widely used for measurements of scar quality. This encompasses visual, tactile and sensory characteristics of the scar. The Patient Scale of previous POSAS versions was lacking input from patients. Therefore, the aim of this study was to develop the POSAS3.0, Patient Scale with involvement of adults patients with all scar types, complying with the highest clinimetric standards. METHODS: From February 2018 to April 2019, a series of six focus group interviews were performed in the Netherlands and Australia to identify scar quality characteristics that adults with scars consider to be important. All focus groups were transcribed, anonymized and analysed using a thematic analysis. Relevant characteristics were formulated into items, resulting in a Dutch and English version of the Patient Scale. These drafts were pilot tested in Australia, the Netherlands and the United Kingdom, and refined accordingly. RESULTS: A total of 21 relevant scar quality characteristics were identified during the focus groups. Two distinct versions of the POSAS3.0, Patient Scale were developed. The Generic version contains 16 items and can be used for all scar types, except linear scars. The Linear Scar version of the Patient Scale contains the same 16 items, with an extra item referring to the widening of scar margins. All included items are rated on a verbal rating scale with five response options. CONCLUSION: Two versions of the POSAS3.0 Patient Scale were developed. Further field tests are being performed to establish the measurement properties and scoring algorithm of the scales.

Acute burn care in resource-limited settings: A cohort study on treatment and outcomes in a rural regional referral hospital in Tanzania.

BACKGROUND: Only a few papers are published on the safety and effectiveness of acute burn care in low-income countries. A cohort study was therefore carried out to determine such outcomes. METHODS: The study was conducted in a rural Tanzanian hospital in 2017-2018. All patients admitted with burns were eligible. Complications were scored during admission as an indication for safety. Survivors of severe burn injuries were evaluated for time of reepithelialization, graft take, disability (WHODAS2.0) and quality of life (EQ5D-3L) up to 3 months post-injury, as an indication of effectiveness. RESULTS: Patients presented on average at 5 days after injury (SD 11, median 1, IQR 0-4). Three patients died at admission. The remaining 79 were included in the cohort. Their median age was 3 years (IQR 2-9, range 0.5-49), mean TBSA burned 12% (SD10%) and mortality rate 11.4%. No surgery-related mortality or life-threatening complications were observed. Skin grafting was performed on 29 patients at a delayed stage (median 23 days, IQR 15-47). Complications of skin grafts included partial (25% of procedures) and complete graft necrosis (8% of procedures). The mean time to reepithelialization was 52 (SD 42) days after admission. Disability and quality of life improved from admission to 3 months after injury (p<0.001, p<0.001, respectively). CONCLUSION: In this resource-limited setting patients presented after a delay and with multiple complications. The mortality during the first two weeks after admission was high. Surgery was found to be safe and effective. A significant improvement in disability and quality of life was observed.

The degree of joint range of motion limitations after burn injuries during recovery.

INTRODUCTION: The aim of this study was to determine the degree of ROM limitations of extremities, joints and planes of motion after burns and its prevalence over time. METHOD: The database of a longitudinal multicenter cohort study in the Netherlands (2011-2012) was used. From patients with acute burns involving the neck, shoulder, elbow, wrist, hip, knee and ankle joints that had surgery, ROM of 17 planes of motion was assessed by goniometry at 3, 6 weeks, 3-6-9 and 12 months after burns and at discharge. RESULTS: At 12 months after injury, 12 out of 17 planes of motion demonstrated persistent joint limitations. The five unlimited planes of motion were all of the lower extremity. The most severely limited joints at 12 months were the neck, ankle, wrist and shoulder. The lower extremity was more severely limited in the early phase of recovery whereas at 12 months the upper extremity was more severely limited. CONCLUSION: The degree of ROM limitations and prevalence varied over time between extremities, joints and planes of motion. This study showed which joints and planes of motion should be watched specifically concerning the development of scar contracture.

Validity of laser speckle contrast imaging for the prediction of burn wound healing potential.

OBJECTIVE: To assess validity of Laser Speckle Contrast Imaging (LSCI) for the measurement of burn wound healing potential (HP) in a burn centre patient population, based on Laser Doppler Imaging (LDI) as reference standard. METHOD: A single-centre prospective observational cohort study was performed between September-December 2019. A total of 50 burns in 14 patients were included. Imaging and data collection were standardized. Correlation between LSCI and LDI flux values was tested. ROC curves were developed to test the discriminative ability of LSCI between LDI HP categories. RESULTS: Number of adults and children were equal. Mean total body surface area burnt was 5.5%. Main burn causes were scalds (64%) and flame burns (36%). LSCI set-up and imaging duration was 3 min and 10 s, respectively. LSCI was able to discriminate between wounds with early versus delayed HP (<14 versus ≥14 days) with sensitivity 71% and specificity 95% (p < 0.001). For HP ≤21 versus >21 days, similar sensitivity (74%) and specificity (95%) were found (p < 0.001). Correlations between LSCI and LDI flux values were moderate (<14 days) to absent (>21 days). CONCLUSION: LSCI shows good validity for the prediction of burn wound HP. It is a highly feasible, patient and physician friendly tool.

The development of burn scar contractures and impact on joint function, disability and quality of life in low- and middle-income countries: A prospective cohort study with one-year follow-up.

OBJECTIVE: The aim of this study was to assess the development of burn scar contractures and their impact on joint function, disability and quality of life in a low-income country. METHODS: Patients with severe burns were eligible. Passive range of motion (ROM) was assessed using lateral goniometry. To assess the development of contractures, the measured ROM was compared to the normal ROM. To determine joint function, the normal ROM was compared to the functional ROM. In addition, disability and quality of life (QoL) were assessed. Assessments were from admission up to 12 months after injury. RESULTS: Thirty-six patients were enrolled, with a total of 124 affected joints. The follow-up rate was 83%. Limited ROM compared to normal ROM values was observed in 26/104 joints (25%) at 12 months. Limited functional ROM was observed in 55/115 joints (48%) at discharge and decreased to 22/98 joints (22%) at 12 months. Patients who had a contracture at 12 months reported more disability and lower QoL, compared to patients without a contracture (median disability 0.28 versus 0.17 (p = 0.01); QoL median 0.60 versus 0.76 (p = 0.001)). Significant predictors of developing joint contractures were patient delay and the percentage of TBSA deep burns. CONCLUSION: The prevalence of burn scar contractures was high in a low-income country. The joints with burn scar contracture were frequently limited in function. Patients who developed a contracture reported significantly more disability and lower QoL. To limit the development of burn scar contractures, timely access to safe burn care should be improved in low-income countries.

Burn scar contracture release surgery effectively improves functional range of motion, disability and quality of life: A pre/post cohort study with long-term follow-up in a Low- and Middle-Income Country.

OBJECTIVE: Burn scar contractures limit range of motion (ROM) of joints and have substantial impact on disability and the quality of life (QoL) of patients, particularly in a Low- and Middle-Income Country (LMIC) setting. Studies on the long-term outcome are lacking globally; this study describes the long-term impact of contracture release surgery performed in an LMIC. METHODS: This is a pre-post cohort study, conducted in a referral hospital in Tanzania. Patients who underwent burn scar contracture release surgery in 2017-2018 were eligible. ROM (goniometry), disability (WHODAS 2.0) and QoL (EQ-5D) were assessed. The ROM data were compared to the ROM that is required to perform activities of daily living without compensation, i.e. functional ROM. Assessments were performed preoperatively and at 1, 3, 6 and 12 months postoperatively. RESULTS: In total, 44 patients underwent surgery on 115 affected joints. At 12 months, the follow-up rate was 86%. The mean preoperative ROM was 37.3% of functional ROM (SD 31.2). This improved up to 108.7% at 12 months postoperatively (SD 42.0, p < 0.001). Disability-free survival improved from 55% preoperatively to 97% at 12 months (p < 0.001) postoperatively. QoL improved from 0.69 preoperatively, to 0.93 (max 1.0) at 12 months postoperatively (p < 0.001). Patients who regained functional ROM in all affected joints reported significantly less disability (p < 0.001) and higher QoL (p < 0.001) compared to patients without functional ROM. CONCLUSIONS: Contracture release surgery performed in an LMIC significantly improved functional ROM, disability and QoL. Results showed that regaining a functional joint is associated with less disability and higher QoL.

Patterns and predictors of burn scar outcome in the first 12 months after burn: The patient's perspective.

OBJECTIVE: This study aimed to provide insight into the patterns and factors that predict burn scar outcomes at 3, 6 and 12 months after burn. METHODS: The Patient and Observer Scar Assessment Scale (POSAS) was used to assess the scar formation of each patient. Structural equation modelling was used. The predictor variables used in this study were sex, three age categories, TBSA, depth of the wound and cause of the burn. RESULTS: The POSAS patient total and individual item scores demonstrated a statistically significant decrease in the first 12 months after burn, except for the relief item. Male patients had a lower total and items scores (better scar quality) for pain and pruritus compared with female patients. Full thickness burns had a higher scores for pruritus, pliability, thickness and relief compared to the partial-thickness burns. Ages younger than 5 years, higher TBSA values and flame burns were predictors of various POSAS items at 3 and 6 months after burn. CONCLUSION: The POSAS patient total and individual item scores demonstrated a statistically significant improvement in the scar quality in the first 12 months after burn, except for the relief. Sex, age, depth of the wound, the percentage of TBSA and flame burns were predictors of various POSAS patient items at 3, 6 and 12 months after burn.

The prevalence and development of burn scar contractures: A prospective multicenter cohort study.

OBJECTIVE: The objective of this study was to identify the prevalence and development of after burn joint limitation by scar contracture. METHODS: In 2011-2012, consecutive patients were enrolled in this prospective multi center cohort study. Eligible were all patients admitted to the 2 participating Dutch Burn Centers with acute burns across or adjacent to the neck, shoulder, elbow, wrist, hip, knee and ankle. Passive range of motion was measured in week 3 and subsequently every 3 weeks until discharge, on discharge from the hospital and during follow-up at the outpatient clinic at 3-6-9-12 months after burn. RESULTS: Limited range of motion of non-operated burned joints (N = 195) was restored back to normal within 6-9 months. From the operated burned joints (N = 353), 58.6% demonstrated a limited range of motion at 3-6 weeks declining to 20.9% at 12 months. The upper part of the body was affected more often by scar contracture than the lower part. At 12 months, the shoulder was limited most often (51.3%) and the hip least often (0%). Reconstructive surgery was performed in 13.3% of the operated burned joints. CONCLUSIONS: Persistent joint limitations at 12 months were exclusively present in joints that needed skin grafting for rapid wound closure. The upper part of the body was more prone to contracture formation than the lower part, from which the shoulder was most often involved. More than half of the limited range of motion seen in the acute phase, resolved in the long term. The need for reconstructive surgery was less than expected.

Design and fabrication of a hybrid alginate hydrogel/poly(ε-caprolactone) mold for auricular cartilage reconstruction.

The aim of this study was to design and manufacture an easily assembled cartilage implant model for auricular reconstruction. First, the printing accuracy and mechanical properties of 3D-printed poly-ε-caprolactone (PCL) scaffolds with varying porosities were determined to assess overall material properties. Next, the applicability of alginate as cell carrier for the cartilage implant model was determined. Using the optimal outcomes of both experiments (in terms of (bio)mechanical properties, cell survival, neocartilage formation, and printing accuracy), a hybrid auricular implant model was developed. PCL scaffolds with 600 µm distances between strands exhibited the best mechanical properties and most optimal printing quality for further exploration. In alginate, chondrocytes displayed high cell survival (~83% after 21 days) and produced cartilage-like matrix in vitro. Alginate beads cultured in proliferation medium exhibited slightly higher compressive moduli (6 kPa) compared to beads cultured in chondrogenic medium (3.5 kPa, p > .05). The final auricular mold could be printed with 300 µm pores and high fidelity, and the injected chondrocytes survived the culture period of 21 days. The presented hybrid auricular mold appears to be an adequate model for cartilage tissue engineering and may provide a novel approach to auricular cartilage regeneration for facial reconstruction. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 107B: 1711-1721, 2019.

Three-dimensional imaging is a novel and reliable technique to measure total body surface area.

OBJECTIVE: The aim of this study was to explore the diverse clinimetric aspects of three-dimensional imaging measurements of TBSA in clinical practice compared with the methods currently used in clinical practice (i.e., the rule of nines and palm method) to measure TBSA in clinical practice. METHOD: To assess reliability, two independent researchers measured the TBSAs of 48 burn patients using Artec MHT™ Scanner and software. Subsequently, a resident and burn specialist estimated the TBSA of the same wounds using the rule of nines and palm method. RESULTS: Three-dimensional imaging showed excellent inter-observer reliability, with an intra-class correlation coefficient (ICC) of 0.99, standard error of measurement (SEM) of 0.054, and limits of agreement (LoA) of ±0.15×the mean TBSA (between the measurements of two researchers). The inter-observer reliability of the methods used in current clinical practice was less reliable, with an ICC of 0.91, SEM of 0.300 and LoA of ±0.78×the mean TBSA. The inter-observer reliability was least reliable between three-dimensional imaging and the residents compared with the burn specialists for the estimated TBSA, with an ICC of 0.68, SEM of 0.69 and LoA of ±1.49×the mean TBSA. CONCLUSION: The inter-observer reliability of three-dimensional imaging was superior compared with the rule of nines and palm method.

The FLIR ONE thermal imager for the assessment of burn wounds: Reliability and validity study.

BACKGROUND: Objective measurement tools may be of great value to provide early and reliable burn wound assessment. Thermal imaging is an easy, accessible and objective technique, which measures skin temperature as an indicator of tissue perfusion. These thermal images might be helpful in the assessment of burn wounds. However, before implementation of a novel measurement tool into clinical practice is considered, it is appropriate to test its clinimetric properties (i.e. reliability and validity). The objective of this study was to assess the reliability and validity of the recently introduced FLIR ONE thermal imager. MATERIAL AND METHODS: Two observers obtained thermal images of burn wounds in adult patients at day 1-3, 4-7 and 8-10 after burn. Subsequently, temperature differences between the burn wound and healthy skin (ΔT) were calculated on an iPad mini containing the FLIR Tools app. To assess reliability, ΔT values of both observers were compared by calculating the intraclass correlation coefficient (ICC) and measurement error parameters. To assess validity, the ΔT values of the first observer were compared to the registered healing time of the burn wounds, which was specified into three categories: (I) ≤14 days, (II) 15-21 days and (III) >21 days. The ability of the FLIR ONE to discriminate between healing ≤21 days and >21 days was evaluated by means of a receiver operating characteristic curve and an optimal ΔT cut-off value. RESULTS: Reliability: ICCs were 0.99 for each time point, indicating excellent reliability up to 10 days after burn. The standard error of measurement varied between 0.17-0.22°C. VALIDITY: the area under the curve was calculated at 0.69 (95% CI 0.54-0.84). A cut-off value of -1.15°C shows a moderate discrimination between burn wound healing ≤21 days and >21 days (46% sensitivity; 82% specificity). CONCLUSION: Our results show that the FLIR ONE thermal imager is highly reliable, but the moderate validity calls for additional research. However, the FLIR ONE is pre-eminently feasible, allowing easy and fast measurements in clinical burn practice.

Indications and Predictors for Reconstructive Surgery After Hand Burns.

PURPOSE: The objective of this study was to analyze the prevalence, indications, and type of reconstructive surgery and predictors of the outcomes of reconstructive surgery after hand burns. METHODS: A retrospective cohort study was conducted that included all patients admitted with acute hand burns in the Dutch burn centers from January 1998 through December 2002. The details of reconstruction including frequency, timing, indication, and techniques were collected over a 10-year follow-up period. RESULTS: Hand burns were seen in 42% (n = 562 of 1,334) of all patients admitted with acute burns. Reconstructive surgery during the 10-year follow-up period was required in 15%. Contractures, especially of the first web space and little finger, were the most frequent indications for reconstructive surgery. Web spaces 1 to 3 and the little finger were the location most frequently operated on. The most frequently performed surgical technique was release of the contractures and the use of a random flap. Eighty percent of the reconstructive surgery patients required more than 1 reconstructive procedure, most often within 2 years of the initial injury. Secondary operations at the same location were required in 12%. In 40% of the patients, the first reconstructive surgery was performed within the first postburn year. Significant independent factors related to the need for reconstructive hand surgery were a larger area of full-thickness burns and surgical treatment of the hand during the acute phase. CONCLUSIONS: Reconstructive surgery was required in 15% of patients who sustained hand burns. The majority of the patients requiring reconstructive surgery of the hand needed 2 or more operations to correct the contractures of the hand. Contractures of the little finger and first web space were the locations most frequently operated on. Patients with more extensive burns and who required hand surgery during the acute phase were more likely to need reconstructive surgery. TYPE OF STUDY/LEVEL OF EVIDENCE: Prognostic IV.

A case report on a burned ear: Elastic memory of cartilage following temporary burial in a skin pocket.

Preserving exposed ear cartilage following a facial burn remains a major challenge. Normally, burned ear cartilage cannot be preserved in case of a full thickness burn of the overlying skin, and the cartilage has to be surgically removed. Sometimes, reconstructions can be performed at a later stage. We report a case where burned ear cartilage was directly surgically buried in a retroauricular skin pocket showing remarkable elastic memory: the buried ear cartilage, in this case the antihelix, regenerated over time and regained its original position protruding from the facial area. This case illustrates that ear cartilage is highly resilient, even when it has sustained significant thermal damage, and can be buried in a retroauricular skin pocket to avoid radical excision of the framework.

Perforator-based flaps for the treatment of burn scar contractures: a review.

Patients with burn scars often experience functional problems because of scar contractures. Surgical treatment may be indicated for those burn scar contractures. If the contractures are small and linear, the contraction bands can be treated with local transposition flaps like the Z-plasty. Broader, diffuse contractures are more challenging and require a different surgical approach, such as the use of local tissue. The use of perforator-based flaps is promising; however, their true clinical significance for this type of burn reconstructions still needs to be determined. Therefore, we performed a review to evaluate the role of perforator-based flaps for burn scar contracture treatment. Electronic databases were searched using a predefined search strategy. Studies evaluating the long-term outcome of perforator-based flaps for the treatment of burn scar contractures were included. The methodological quality was tested and data was summarized. Five hundred and ten papers were identified of which eleven met the inclusion criteria. One study was a randomized controlled trial; ten were cohort studies of a pre-postoperative design. The papers described outcomes of free flaps and local flaps. Most studies had methodological shortcomings and used inappropriate statistical methods. Perforator-based interposition flaps appear to be highly relevant for burn scar contracture treatment. However, due to the paucity and low quality of the studies that were assessed, no definitive conclusions about the true clinical significance could be reached. And therefore, only recommendations could be given for improvement of the quality of further primary research on the effectiveness of perforator-based flaps for burn scar contracture release.