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.

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.

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.

Doxepin cream is not effective in reducing itch in burn scar patients: A multicenter triple-blind randomized clinical crossover trial.

OBJECTIVE: To evaluate the effect of doxepin hydrochloride 5% cream on reducing pruritus in burn scar patients compared to a placebo cream. METHOD: We conducted a multicenter triple-blind randomized clinical placebo-controlled crossover trial in which burn patients ≥18 years with an itch intensity ≥3 on a Visual Analogue Scale (VAS) were randomized between a doxepin-placebo or placebo-doxepin treatment protocol. Patients used each cream during two weeks with a wash-out period of one week in between. Primary outcome was change in itch intensity in two weeks' time using the VAS. Secondary outcome included the impact of itch (Burn Itch Questionnaire). Other parameters were the use of hydrating cream, silicon treatment, pressure garments, and other antipruritic medication. RESULTS: Twenty-seven patients were included. The change in itch intensity (VAS) was not different during the doxepin and placebo period (p=0.994); neither the doxepin cream nor placebo cream reduced itch intensity. However, based on the Burn Itch Questionnaire, we observed a statistically significant decrease in itch intensity and improvement in impact scores in both treatment groups, but no difference in the degree of reduction between the groups. CONCLUSION: Doxepin cream was not effective in reducing pruritus in our burn patient study population.

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.

Acquired undescended testes and fertility potential: is orchiopexy at diagnosis better than awaiting spontaneous descent?

The aim of this study was to evaluate testicular function in men with previous acquired undescended testis (UDT) in whom orchiopexy was performed at diagnosis compared with a similar group of men in whom spontaneous descent was awaited until puberty. Secondly, we examined the influence of age at orchiopexy on fertility parameters in adult life. A total of 169 men of the 'orchiopexy at diagnosis' group and 207 men of the 'wait and see' protocol group were invited for participation. All participants underwent an andrological evaluation, including medical history, physical examination, scrotal ultrasound, determination of reproductive hormones, and semen analysis. Results were compared for men in whom orchiopexy was performed at diagnoses with men in whom spontaneous descent was awaited until puberty followed by orchiopexy in case of non-descent. In the 'orchiopexy at diagnosis' group, 63 men of whom 14 with bilateral UDT, and in the 'wait and see' protocol group, 65 men of whom 15 with bilateral UDT were included. For unilateral UDT Inhibin B was found to be significantly lower and median progressive motility was higher in men with orchiopexy at diagnosis. For bilateral UDT, semen concentration and progressive motility showed a trend toward a favorable outcome for orchiopexy at diagnosis. Age at orchiopexy being under or above 10 years of age had no significant influence on the fertility potential. The outcome of physical examination, scrotal ultrasound, endocrine function, and semen analysis indicates a compromised fertility potential in men with previous acquired UDT. None of the protocols proved to be superior. For bilateral UDT, a trend toward favorable outcome of orchiopexy at diagnosis was seen. Furthermore, age at orchiopexy did not have an influence on fertility parameters. Therefore, in our opinion a 'conservative policy' is warranted for unilateral UDT, especially because over 50% of acquired UDT descend spontaneously.

Uptake of (18)F-fluoro-2-deoxyglucose in the Healthy Testes of Young Men as Assessed by Positron Emission Tomography/Computed Tomography; Including the Inter- and Intra-observer Variation.

Knowledge of the physiological testicular accumulation of (18)F-fluoro-2-deoxyglucose (FDG) is essential in order to discriminate between normal and pathological findings. In this study, the (18)F-FDG-uptake in healthy testes of young men was assessed using positron emission tomography/computed tomography (PET/CT)-scans. A total of 40 testes of 20 men with a mean age of 26.5 ± 3.9 years were evaluated. (18)F-FDG-uptake was expressed as the standardized uptake value (SUV). Testicular volume was measured on CT and PET. All scans were assessed by three researchers, one of whom assessed every scan twice. Laterality indices and inter- and intra-observer variation were evaluated. Correlation between the SUVmax and SUVpeak, between SUVmean and SUVpeak and between age and SUVpeak were assessed. Testes showed an average SUVmax of 3.42 ± 0.61, SUVpeak of 3.06 ± 0.54 and SUVmean of 2.44 ± 0.44. The average testicular volume on CT was 23.0 ± 6.4 ml, whereas on PET it was 18.0 ± 5.1 ml. Laterality indices were calculated of 0.077 ± 0.065 (SUVmax), 0.074 ± 0.066 (SUVpeak), 0.072 ± 0.063 (SUVmean), 0.245 ± 0.259 (CT), and 0.200 ± 0.188 (PET), respectively. Inter- and intra-observer reliability were found to be perfect for the SUVs (intraclass correlation coefficient [ICC] 0.992-1.0), but poor for testicular volumes (ICC 0.854-0.902). Testicular (18)F-FDG uptake in young men can be measured accurately on PET/CT and shows high symmetry. Consequently, (18)F-FDG PET/CT has the potential to become a useful instrument in the evaluation of the functioning of the individual testis.

Testicular microlithiasis in acquired undescended testis after orchidopexy at diagnosis.

The aim of this study was to observe the prevalence of testicular microlithiasis (TM) in surgically corrected acquired undescended testis (UDT). The prevalence of TM was assessed by ultrasound. Boys and young men who had undergone orchidopexy (ORP) for acquired UDT in mid or late childhood were observed to study the long-term testicular volume. During this examination, the presence or absence of TM was also assessed. TM was defined as echogenic foci without shadowing within the testis parenchyma. We included 106 patients who had undergone ORP at the Medical Center Alkmaar (1986-1999) and 155 patients who had undergone ORP at the Juliana Children's Hospital (1996-2009). The majority of patients were white, Caucasian (82%). The median age at follow-up, 25.8 years (range 14.0-31.6 years) was higher in Medical Center Alkmaar than in Juliana Children's Hospital 13.4 years (range 5.1-26.6 years). From 2009 to 2011, these 261 patients (median age 18.9 years) underwent an ultrasound examination. Median follow-up after ORP was 11.3 years (range 1.4-23.5 years); age at ORP ranged from 2.1 to 16.2 years, with a median of 8.5 years. TM was found in 17 (6.5%) patients (median age at follow-up 20.4 years; range 11-28). No significant association was found with the incidence of TM and the operated testis, the age at ORP or the racial variance (p > 0.05). ORP at diagnosis for acquired UDT is associated with a 6.5% prevalence of TM in boys and young adults.

Normative values for testicular volume measured by ultrasonography in a normal population from infancy to adolescence.

BACKGROUND/AIMS: We obtained reference data for testicular volume measured by ultrasound in asymptomatic boys aged 0.5-18 years. In addition, we assessed the validity of the Prader orchidometer per age group by correlating it with the volume measurement by ultrasound. METHODS: The study only included healthy boys with two scrotal testes at birth and at the time of the examination. For each boy the testicular volume of both testes was measured by ultrasound and the Prader orchidometer. Testicular volumes were measured for boys aged from 1 to 18 years. The boys' ages were rounded down to the last birthday if it had occurred less than 6 months previously or rounded up to the next birthday if it was going to be within 6 months. RESULTS: The volume measurement by the Prader orchidometer according to reference curves showed a statistically significant correlation. Moreover, the testicular volumes measured by the Prader orchidometer showed an accurate goodness of fit with US measurements (R(2) = 0.956). CONCLUSION: Normative values are provided for testicular volume measured by ultrasound in boys aged 0.5-18 years. An accurate correlation was found between volume measurements by ultrasound and by the Prader orchidometer (R(2) = 0.956). Therefore, volume measurement by the Prader orchidometer, as generally used in the practice by doctors, can be used as a valid parameter for monitoring testicular growth.