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Identifying outcomes that matter most is key in driving specialized paediatric burn care. The aim of this study was to discover the most important outcomes for paediatric burns. Parents of children (0-3 year and 4-11 years old) and adolescents (12-17 yearss old) completed surveys to identify outcomes that matter most in the short-term (<6 months postburn) and long-term (6-24 months postburn). The percentage of patients scoring an outcome as 'very important' was used to rank the outcomes. Fifty-four parents/adolescents participated (response rate: 27%). Children had a median TBSA burned of 5.0% (IQR: 2.0-7.0%). In the short-term, 'good wound healing' and 'no wound infection' (both at 71.4-100%) were very important for all children. 'Not having pain' (90.3-93.8%) was ranked highest for children ≤11 years old, whereas 'walking or moving around' (85.7%) was most important for older children. In the long-term, more variation was seen in outcome priorities; however, both 'not having pain' (53.6-85.7%) and 'flexibility of scar(s)' (60.7-71.4%) were considered very important by all three groups. Patient- and parent-derived priorities are important for developing consumer-centric, highest-value care pathways. The priority of the outcomes identified is a starting point to discuss treatment options and recovery priorities in a family-centric approach to guide high-value, individualized 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., Competing Interests: Declaration of Competing Interest Not applicable., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Burn care quality indicators are used to monitor and improve quality of care and for benchmark purposes. The perspectives of burn survivors, however, are not included in current sets of quality indicators while patient-centred care gains importance. The aim of this study was to explore burn survivors' perspectives on quality aspects of burn care, which was used to translate their perspectives into patient-centred quality of care indicators. Qualitative descriptive research was conducted in a patient panel group. First, thematic analysis was applied to the focus groups to identify overarching themes. Second, patient-centred quality indicators, informed by burn survivors' valued aspects of care, were defined. Ten burn survivors with an average age of 54 years (SD = 11; range 38-72 years) and mean TBSA burned of 14% (SD = 11%; range 5-35%) participated in two focus groups. Four overarching themes were identified, pointing to the importance of (1) information tailored to the different phases of recovery, (2) significant others' wellbeing and involvement, (3) a therapeutic relationship and low-threshold access to healthcare professionals and (4) to participate in decision-making. Eighteen patient-centred process quality of care indicators within nine aspects of care were formulated. The overarching themes are reflected in patient-centred quality indicators, which present a broadened and complementary view of existing clinical quality indicators for burn care. Evaluating these patient-centred quality indicators may increase quality of care and refine patient-centred care.

Importance: Hyperbaric oxygen therapy (HBOT) is proposed as treatment for late local toxic effects after breast irradiation. Strong evidence of effectiveness is lacking., Objective: To assess effectiveness of HBOT for late local toxic effects in women who received adjuvant radiotherapy for breast cancer., Design, Setting, and Participants: This was a hospital-based, pragmatic, 2-arm, randomized clinical trial nested within the prospective UMBRELLA cohort following the trials within cohorts design in the Netherlands. Participants included 189 women with patient-reported moderate or severe breast, chest wall, and/or shoulder pain in combination with mild, moderate, or severe edema, fibrosis, or movement restriction 12 months or longer after breast irradiation. Data analysis was performed from May to September 2023., Intervention: Receipt of 30 to 40 HBOT sessions over a period of 6 to 8 consecutive weeks., Main Outcomes and Measures: Breast, chest wall, and/or shoulder pain 6 months postrandomization measured by the European Organization for Research and Treatment of Cancer QLQ-BR23 questionnaire. Secondary end points were patient-reported fibrosis, edema, movement restriction, and overall quality of life. Data were analyzed according to intention-to-treat (ITT) and complier average causal effect (CACE) principles., Results: Between November 2019 and August 2022, 125 women (median [range] age at randomization, 56 [37-85] years) with late local toxic effects were offered to undergo HBOT (intervention arm), and 61 women (median [range] age at randomization, 60 [36-80] years) were randomized to the control arm. Of those offered HBOT, 31 (25%) accepted and completed treatment. The most common reason for not accepting HBOT was high treatment intensity. In ITT, moderate or severe pain at follow-up was reported by 58 of 115 women (50%) in the intervention arm and 32 of 52 women (62%) in the control arm (odds ratio [OR], 0.63; 95% CI, 0.32-1.23; P = .18). In CACE, the proportion of women reporting moderate or severe pain at follow-up was 32% (10 of 31) among those completing HBOT and 75% (9.7 of 12.9) among control participants expected to complete HBOT if offered (adjusted OR, 0.34; 95% CI, 0.15-0.80; P = .01). In ITT, moderate or severe fibrosis was reported by 35 of 107 (33%) in the intervention arm and 25 of 49 (51%) in the control arm (OR, 0.36; 95% CI, 0.15-0.81; P = .02). There were no significant differences in breast edema, movement restriction, and quality of life between groups in ITT and CACE., Conclusions and Relevance: In this randomized clinical trial, offering HBOT to women with late local toxic effects was not effective for reducing pain, but was effective for reducing fibrosis. In the subgroup of women who completed HBOT, a significant reduction in pain and fibrosis was observed. A smaller than anticipated proportion of women with late local toxic effects was prepared to undergo HBOT., Trial Registration: ClinicalTrials.gov Identifier: NCT04193722.

To optimize patient recovery, understanding which outcomes are most important to burn patients is key. However, research to determine what outcomes are patient priorities is limited. Therefore, we assessed what outcomes are most important to Western Australian burn patients, separately in the short-term (<6 months) and long-term (6-24 months) after injury. Adult patients who had a burn injury 3-36 months ago completed a survey, rating the importance of 36 short- and long-term outcomes. The survey items were ranked according to the number of patients reporting the outcome as "very important." Results were compared between subgroups based on age, gender, burn size, and number of surgeries. Ninety-three patients were included. In the short-term, "not having a wound infection" (87.1%), "good wound healing" (83.9%), and "walking or moving around" (74.7%) were the most important outcomes. "Lifting or moving something" (67.6%), "walking or moving around" (66.2%), and "being independent" (66.2%) were reported as most important in the long-term. Scar-related outcomes were more important to females and to patients with multiple surgeries; mental health outcomes were priorities for females and patients with major burns; walking and moving around to males and older patients; and social and financial outcomes were rated highly by patients with major burns and multiple surgeries. In conclusion, the most important outcomes were consistent across time periods, indicating the importance of core outcomes in longitudinal follow-up. The wide range of priority outcomes and differences between subgroups underlines the need for multidisciplinary care and a patient-centered approach to support patients., (© The Author(s) 2023. Published by Oxford University Press on behalf of the American Burn Association.)

Background: The use of patient-reported outcomes to improve burn care increases. Little is known on burn patients' views on what outcomes are most important, and about preferences regarding online Patient Reported Outcome Measures (PROMs). Therefore, this study assessed what outcomes matter most to patients, and gained insights into patient preferences towards the use of online PROMs., Methods: Adult patients (≥18 years old), 3-36 months after injury completed a survey measuring importance of outcomes, separately for three time periods: during admission, short-term (<6 months) and long-term (6-24 months) after burn injury. Both open and closed-ended questions were used. Furthermore, preferences regarding the use of patient-reported outcome measures in burn care were queried., Results: A total of 140 patients were included (response rate: 27%). 'Not having pain' and 'good wound healing' were identified as very important outcomes. Also, 'physical functioning at pre-injury level', 'being independent' and 'taking care of yourself' were considered very important outcomes. The top-ten of most important outcomes largely overlapped in all three time periods. Most patients (84%) had no problems with online questionnaires, and many (67%) indicated that it should take up to 15 minutes. Patients' opinions differed widely on the preferred frequency of follow-up., Conclusions: Not having pain and good wound healing were considered very important during the whole recovery of burns; in addition, physical functioning at pre-injury level, being independent, and taking care of yourself were deemed very important in the short and long-term. These outcomes are recommended to be used in burn care and research, although careful selection of outcomes remains crucial as patients prefer online questionnaires up to 15 minutes., Competing Interests: Declaration of Competing Interest All authors whose names are listed immediately below have no financial and personal relationships with other people or organisations that could inappropriately influence (bias) their work. Examples of potential conflicts of interest include employment, consultancies, stock ownership, honoraria, paid expert testimony, patent applications/registrations, and grants or other funding., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Purpose: This systematic review aims to provide an overview of the literature on the effect of hyperbaric oxygen therapy (HBOT) on symptoms of local late radiation toxicity (LRT) in patients treated for breast cancer., Methods: A systematic search was performed in September 2021. All studies with a sample size of ≥10 patients reporting the effect of HBOT for symptoms of LRT after radiotherapy of the breast and/or chest wall were included. The ROBINS-I tool was used for critical appraisal of methodological quality. The toxicity outcomes pain, fibrosis, lymphedema, necrosis/skin problems, arm and shoulder mobility, and breast and arm symptoms were evaluated., Results: Nine studies concerning a total of 1308 patients were included in this review. Except for one study, sample sizes were small. Most studies had inadequate methodology with a substantial risk of bias. Post-HBOT, a significant reduction of pain was observed in 4/5 studies, of fibrosis in 1/2 studies, and of lymphedema of the breast and/or arm in 4/7 studies. Skin problems of the breast were significantly reduced in 1/2 studies, arm- and shoulder mobility significantly improved in 2/2 studies, and breast- and arm symptoms were significantly reduced in one study., Conclusion: This systematic review indicates that HBOT might be useful for reducing symptoms of LRT in breast cancer patients, however evidence is limited. A randomized controlled trial in a larger cohort of patients including a combination of patient- and clinician-reported outcome measures would be valuable to assess the effect of HBOT on symptoms of LRT., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Previously published short-term results (week 16) of this trial showed a significant improvement in clinical, radiologic and biochemical outcomes in Crohn's disease patients with therapy-refractory perianal fistulas after treatment with hyperbaric oxygen therapy., Objective: To assess the long-term (week 60) efficacy, safety and feasibility of hyperbaric oxygen therapy in perianal fistula in Crohn's disease., Methods: Crohn's disease patients with high perianal fistula(s) failing conventional treatment >6 months were included. Exclusion criteria were presence of a stoma, rectovaginal fistula(s) and recent changes in treatment regimens. Patients received 40 hyperbaric oxygen sessions and outcomes were assessed at week 16 and week 60., Results: Twenty patients were included (median age 34 years). At week 16, median scores of the perianal disease activity index and modified Van Assche index (co-primary outcomes) decreased from 7.5 (95% CI 6-9) to 4 (95% CI 3-6, p < 0.001) and 9.2 (95% CI 7.3-11.2) to 7.3 (95% CI 6.9-9.7, p = 0.004), respectively. At week 60, the respective scores remained significantly lower than baseline: 4 (95% CI 3-7, p < 0.001) and 7.7 (95% CI 5.2-10.2, p = 0.003). Perianal disease activity index score of 4 or less (representing inactive perianal disease) was observed in 13 patients at week 16 and 12 patients at week 60. Using fistula drainage assessment, 12 and 13 patients showed a clinical response at week 16 and 60, respectively, and clinical remission was achieved in four patients for both time points. At week 16, a statistically significant biochemical improvement (C-reactive protein and faecal calprotectin levels) was found, but this effect was no longer significant at week 60., Conclusions: The clinical and radiologic improvement of perianal fistula in Crohn's disease, that was found at week 16 after treatment with hyperbaric oxygen therapy, is maintained at 1-year follow-up., (© 2021 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.)

Background: Positive effects of hyperbaric oxygen (HBO) on perianal fistulas in Crohn's disease (CD) have been described, but the effect on rectovaginal fistulas (RVFs) has not yet been studied. The aim was to investigate the efficacy, safety and feasibility of HBO in patients with RVF in CD., Methods: In this prospective study, consecutive CD patients between November 2018 and February 2020 presenting with RVF at the outpatient fistula clinic of the Amsterdam University Medical Centre were included and selected to receive treatment with 30 daily HBO sessions, if fistulas were actively draining and any concomitant treatment regimen was stable at least 6 weeks prior to start of HBO. Patients with a stoma were excluded. The primary endpoint was clinical closure at 3-month follow-up, defined as cessation of complaints and/or closure of the external orifice if visible at baseline. Secondary outcomes were improvement of concomitant perianal fistulas as measured by the perianal disease activity index (PDAI) and fistula drainage assessment (FDA), as well as improvement in patient-reported outcomes (visual analogue scale (VAS), inflammatory bowel disease questionnaire (IBDQ), faecal incontinence quality of life scale (FIQL) and female sexual functioning index (FSFI)) at 3-month follow-up., Results: Out of 14 eligible patients, nine patients (median age 50 years) were treated, all of whom had previously had one or more unsuccessful medical and/or surgical treatments for their RVF. Clinical closure occurred in none of the patients at 3-month follow-up. There was no improvement in PDAI and patient-reported outcomes (VAS, IBDQ, FIQL and FSFI). Two patients had concomitant perianal fistulas; using FDA, one patient had a clinical response and one patient was in clinical remission 3 months after HBO. There were two treatment-related adverse events during HBO concerning claustrophobia and fatigue. Furthermore, two patients had a surgical intervention due to RVF and two patients were treated with antibiotics for a urinary tract infection during follow-up. One patient had a dose reduction of ustekinumab because of decreased luminal complaints., Conclusion: Treatment with HBO was feasible, but in this therapy-refractory cohort without deviating ostomy no clinical closure of RVF or improvement in quality of life was seen 3 months after HBO. Treatment with HBO alone in this specific group of patients therefore appears to be ineffective., (© The Author(s) 2021. Published by Oxford University Press on behalf of BJS Society Ltd.)

Background: Positive effects of hyperbaric oxygen on perianal fistulas in Crohn's disease have been reported., Aim: To assess efficacy, safety and feasibility of hyperbaric oxygen in Crohn's disease patients with therapy-refractory perianal fistulas., Methods: Twenty consecutive patients were recruited at the out-patient fistula clinic of the Amsterdam UMC. Crohn's disease patients with high perianal fistula(s) failing conventional treatment for over 6 months were included. Exclusion criteria were presence of a stoma, rectovaginal fistula(s) and recent changes in treatment regimens. Patients received treatment with 40 hyperbaric oxygen sessions and outcome parameters were assessed at Week 16., Results: Seven women and 13 men were included (median age 34 years). At Week 16, median scores of perianal disease activity index and modified van Assche index (co-primary outcome parameters) decreased from 7.5 (95% CI 6-9) to 4 (95% CI 3-6, P < 0.001), and from 9.2 (95% CI 7.3-11.2) to 7.3 (95% CI 6.9-9.7, P = 0.004) respectively. Perianal disease activity index scores ≤4 (representing inactive perianal disease) were observed in 13/20 patients (65%). Twelve patients showed a clinical response (60%) and four (20%) clinical remission, assessed with fistula drainage assessment. Median C-reactive protein and faecal calprotectin levels decreased from 4.2 mg/mL (95% CI 1.6-8) to 2.2 (95% CI 0.9-4.3, P = 0.003) and from 399 µg/g (95% CI 52-922) to 31 (95% CI 16-245, P = 0.001), respectively., Conclusions: We found significant clinical, radiological and biochemical improvement in Crohn's disease patients with therapy-refractory perianal fistulas after treatment with hyperbaric oxygen., Clinical Trial Registration: www.trialregister.nl/trial/6489., (© 2020 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.)

Decompression sickness (DCS) is a condition arising when dissolved inert gas in tissue forms extravascular and/or intravascular bubbles during or after depressurisation. Patients are primarily treated with 100% oxygen and recompression, which is often assumed to lead to resolution of bubbles. After this, repeated hyperbaric exposures can be provided in case of persistent symptoms, with oxygen delivery to ischaemic tissues, anti-inflammatory properties and reduction of oedema considered the main mechanisms of action. In this case report we present the history and imaging of a diver diagnosed with DCS that was treated with two US Navy Treatment Table 6 recompressions, but who still had multiple extravascular bubbles apparent on CT-imaging after these hyperbaric treatments. Based on these findings we hypothesise that, contrary to general belief, it is possible that large extravascular bubbles can persist after definitive treatment for DCS., (Copyright: This article is the copyright of the authors who grant Diving and Hyperbaric Medicine a non-exclusive licence to publish the article in electronic and other forms.)

Background: Metastatic Crohn's disease (CD) is a rare manifestation of CD. It involves inflammatory skin lesions with histopathological findings (granulomas) similar to CD, without connection to the gastrointestinal tract. Hyperbaric oxygen therapy (HBO) has been suggested as a possible treatment option., Objective: This study aimed to identify and treat a consecutive series of patients with biopsy-proven metastatic CD and monitor wound healing using prospectively acquired outcomes., Methods: Pathology results of all patients with ongoing perineal wound-healing problems after proctectomy between 2005 and 2018 at the Amsterdam University Medical Centre were assessed for metastatic CD. Patients with a biopsy-proven diagnosis of perineal metastatic CD were offered HBO (40 daily sessions of 100% oxygen at 2.4 atmosphere absolute). Wound healing was monitored using photographs and standardised questionnaires (the Inflammatory Bowel Disease Questionnaire, EuroQol Visual Analogue Scale and the Female Sexual Function Index) at baseline and 1 and 3 months after HBO., Results: Out of 13 patients in the cohort with persisting perineal wounds after proctectomy, six (46%) had biopsy results consistent with metastatic CD. Of these, three accepted treatment with HBO. All three patients were female. One patient had complete healing of her perineal wound; another patient showed initial improvement but had a flare of luminal and perineal disease at the 3-month follow-up. The third patient showed improvement solely in the questionnaires, with higher scores on all three questionnaires., Conclusion: A high rate of metastatic CD was found in patients with ongoing wound-healing problems after proctectomy, implying that the disease might not be as rare in these selected patients as previously thought. HBO might be beneficial in the treatment of metastatic CD.

Background and Objectives: Sarcomas are commonly managed by surgical resection combined with radiotherapy. Sarcoma treatment is frequently complicated by chronic wounds and late radiation tissue injury (LRTI). This study aims to gain insight in the use and results of hyperbaric oxygen therapy (HBOT) for radiation-induced complications following sarcoma treatment., Methods: All sarcoma patients treated between 2006 and 2017 in one of the five centers of the Institute for Hyperbaric Oxygen in the Netherlands were included for retrospective analysis., Results: Thirty patients were included, 18 (60.0%) patients were treated for chronic wounds and 12 (40.0%) for LRTI. Two patients with chronic wounds were excluded from analysis as HBOT was discontinued within five sessions. In 11 of 16 (68.8%) patients treated for chronic wounds, improved wound healing was seen. Nine of 12 (75.0%) patients treated for LRTI reported a decline in pain. Reduction of fibrosis was seen in five of eight patients (62.5%) treated for LRTI., Conclusions: HBOT is safe and beneficial for treating chronic wounds and LRTI in the sarcoma population. Awaiting further prospective results, we recommend referring to HBOT centers more actively in patients experiencing impaired wound healing or symptoms of delayed radiation-induced tissue injury following multimodality sarcoma treatment., Competing Interests: The authors have declared no competing interests exist.

Background: Structured evaluation of magnetic resonance imaging (MRI) is important to guide clinical decisions of perianal fistulas in Crohn's disease (CD) patients., Purpose: To evaluate the recently developed modified Van Assche index to assess clinical responses to anti-tumor necrosis factor (TNF) therapy in patients with perianal fistulizing CD., Methods: A search of medical records identified patients with fistulizing perianal CD who underwent baseline and follow-up MRI while receiving anti-TNF treatment. Patients were divided into clinical responders and non-responders based on physician's assessment. MRI-scans were scored using the original and modified Van Assche index and scores between baseline and follow-up were compared within clinical responders and non-responders., Results: Thirty cases were included (48% female, median age 27 years). Clinical responders (n = 16) had a median modified Van Assche score of 9.6 (IQR 5.8-12.7) at baseline and 5.8 (IQR 3.5-8.5) at follow-up (p = 0.008). In non-responders (n = 14), corresponding scores were 7.7 (IQR 5.8-13.5) and 8.2 (IQR 5.8-11.5) (p = 0.624). In clinical responders, 6/16 showed no drop in modified Van Assche score at follow-up. Scores obtained with the original Van Assche index dropped between baseline and follow-up in clinical responders (13.0 vs. 9.6, p = 0.011), whereas no decrease was observed in non-responders (11.5 vs. 11.5, p = 0.324)., Conclusions: While the modified Van Assche index overall decreases significantly in patients with perianal fistulas responding to anti-TNF treatment, one third of responders had unaltered scores at follow-up. Also, outcomes were comparable to the original Van Assche index. Further optimization of the modified Van Assche index is needed before application in larger studies., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Dermal injection of fillers is a popular and relatively safe aesthetic procedure. Severe complications are rare, but they do occur. One of the most threatening complications after dermal filler injection is skin necrosis due to vascular occlusion. Different treatment options are available, including the use of hyperbaric oxygen (HBO2) therapy. A 46-year-old female received facial dermal filler injections with calcium hydroxylapatite at an aesthetic clinic. A few days after injection she developed a burning pain, numbness of the skin and white discoloration in the injected area. Two days after injection treatment was started with hyaluronidase and warm compresses. In addition, the patient received prednisolone, sildenafil and nifedipine. After the start of these treatments, the pain, numbness and discoloration of the skin persisted. Because of dermal ischemia and to improve healing she was referred for HBO2. Treatment consisted of 10 sessions of 100% oxygen for 90 minutes in a multiplace chamber at 2.5 atmospheres absolute pressure. During HBO2 the discoloration resolved, pain and numbness disappeared, and the tissue healed completely. After a six-month follow-up she had an excellent cosmetic outcome. Given the pathophysiologic mechanisms of vascular complications after dermal filler injection, HBO2 should be considered when treating these complications., Competing Interests: The authors of this paper declare no conflicts of interest exist with this submission., (Copyright© Undersea and Hyperbaric Medical Society.)

Background: Perianal fistulizing Crohn's disease (pCD) has a significant impact on patients' health and quality of life. Current treatment options have a relatively low success rate and a high recurrence risk. Positive effects of hyperbaric oxygen (HBO2) therapy have been indicated in animal studies as well as in small case series., Methods/design: This is a non-randomized, controlled pilot study. A total of 20 patients with pCD who have been refractory to standard therapy for at least six months will be included. Patients with a seton and stable treatment regimen will be included. Patients with anal strictures, rectovaginal fistulas, stoma or deep ulceration of the rectum will be excluded. Patients who are eligible but refuse HBO2 will be asked to serve as controls. Patients in the HBO2 group will be treated with 40 sessions of HBO2 therapy at 243-253 kPa, with the seton being removed after 30 sessions. Co-primary endpoints are changes in the perianal disease activity index and MRI-scores. Secondary outcomes are fistula drainage assessment, laboratory findings and patient-reported outcomes. Assessment will be done at baseline, 16 weeks, 34 weeks and 60 weeks after finishing HBO2., Discussion: The aim of this study is to investigate the feasibility and therapeutic effect of HBO2 on pCD. The one-year follow-up should provide information on the effect durability. A comparison between patients treated with HBO2 and patients who continue to receive standard care will be made. The risk of bias will be limited by using clearly defined inclusion and exclusion criteria, baseline characteristics and consecutive recruitment of patients through an outpatient fistula clinic., Trial Registration: The HOT-TOPIC trial has been approved by the local Medical Ethical Committee of the Academic Medical Centre in Amsterdam, the Netherlands. The trial has been registered at the Netherlands Trial Register (www.trialregister.nl), registration number: NTR 6676. Protocol version: August 2017, version 3.0., Competing Interests: The authors of this paper declare no conflicts of interest exist with this submission., (Copyright © Undersea and Hyperbaric Medical Society.)

Background Hyperbaric oxygen therapy, which consists of breathing 100% oxygen under a higher atmospheric pressure than normal, is utilized worldwide in the treatment of several diseases. With the growing demand for evidence-based research, hyperbaric oxygen therapy has been criticized for delivering too little high-quality research, mainly in the form of randomized controlled trials. While not always indispensable, the addition of a sham-controlled group to such a trial can contribute to the quality of the research. However, the design of a sham (hyperbaric) treatment is associated with several considerations regarding adequate blinding and the use of pressure and oxygen. This narrative review discusses information on the sham profile and the blinding and safety of double-blind trials in hyperbaric medicine, irrespective of the indication for treatment. Methods MEDLINE, Embase and CENTRAL were searched for sham-controlled trials on hyperbaric oxygen therapy. The control treatment was considered sham if patients were blinded to their allocation and treatment took place in a hyperbaric chamber, with no restrictions regarding pressurization, oxygen levels or indication. Studies involving children or only one session of hyperbaric oxygen were excluded. Information on (the choice of) treatment profile, blinding measures, patient's perception regarding allocation and safety issues was extracted from eligible studies. Results A total of 42 eligible trials were included. The main strategies for sham treatment were (1) use of a lower pressure than that of the hyperbaric oxygen group, while breathing 21% oxygen; (2) use of the same pressure as the hyperbaric oxygen group, while breathing an adjusted percentage of oxygen; and (3) use of the same pressure as the hyperbaric oxygen group, while breathing 21% oxygen. The advantages and disadvantages of each strategy are discussed using the information provided by the trials. Conclusion Based on this review, using a lower pressure than the hyperbaric oxygen group while breathing 21% oxygen best matches the inertness of the placebo. Although studies show that use of a lower pressure does allow adequate blinding, this is associated with more practical issues than with the other strategies. The choice of which sham profile to use requires careful consideration; moreover, to ensure proper performance, a clear and detailed protocol is also required.

Frostbite is an injury caused by the freezing of tissue, causing varied levels of tissue damage and necrosis. Case reports have shown a positive effect of hyperbaric oxygen (HBO₂) in such injuries, in acute cases as well as delayed (up to 21 days) presentation with complications. In this case report we present the course of hyperbaric treatment of two patients (a brother and sister, age 58 and 62) who sustained frostbite injuries to both feet 28 days earlier while hiking in the Himalayas. They were initially treated in Nepal following local protocol; afterward their primary care in the Netherlands was managed by the Burn Centre at Maasstad Hospital in Rotterdam. Both patients were treated with daily sessions of in total 80 minutes of 100% oxygen at 2.5 atmospheres absolute. The female patient (age 62) received 25 sessions and showed a remarkable preservation of tissue and quick demarcation. Only partial surgical amputation of the second toe on the right was needed. In the male patient (age 58) both front feet were already mummified to a larger extent before start of treatment. During hyperbaric oxygen therapy 30 sessions) demarcation progressed quickly, resulting in early surgical amputation. Both patients experienced no side effects of HBO₂ treatment. Given that both patients showed a quick progress and demarcation of their wounds, with remarkable tissue preservation in the female patient, we suggest that hyperbaric oxygen therapy should be considered in treating frostbite injuries, in acute as well as delayed cases, even four weeks after initial injury., Competing Interests: The authors of this paper declare no conflicts of interest exist with this submission., (Copyright© Undersea and Hyperbaric Medical Society.)

Background: Lichen sclerosus (LS) is a chronic inflammatory skin disease. Earlier studies have shown an impaired health-related quality of life (HRQoL), but more extensive research including generic questionnaires has not been reported., Objectives: To investigate, in a cross-sectional study, the HRQoL of a sample of Dutch women with LS; to compare the resulting HRQoL data with that available from other skin diseases and the general Dutch population; to explore factors that may influence the HRQoL., Methods: Female members of the Dutch LS Foundation and Support Group filled out three questionnaires electronically: the Skindex-29, the SF-12 and the EQ-5D visual analogue scale (VAS). We distinguished Skindex-29 scores into groups with 'little' (score 0-24), 'mild' (25-31), 'moderate' (32-43) and 'severe' (44-100) impact on HRQoL. We compared differences using the Mann-Whitney U-test and the Kruskal-Wallis test, and correlations using Spearman's rank correlation coefficient., Results: A total of 262 women with LS were included. The average diagnostic delay was 4·9 (SD 7·1) years. Patients had a mean total Skindex-29 score of 38·4 (0-100, SD 17·2). Domain scores for symptoms, emotions and functioning were 46·8 (SD 19·0), 38·2 (SD 20·2) and 33·6 (SD 19·3), respectively. The SF-12 showed average PCS-12 (physical component) and MCS-12 (mental component) scores of 47·7 and 48·5, respectively. For the Dutch population these scores were 49·3 and 52·3. The mean EQ-5D VAS score was 74·1 (SD 15·4)., Conclusions: There is a considerable delay in diagnosis for female Dutch patients with LS. The Skindex-29 domain scores showed a moderately impaired HRQoL. Women with LS reported a lower generic HRQoL than the average female Dutch population., (© 2012 The Authors. BJD © 2012 British Association of Dermatologists.)