Outcomes that matter most to burn patients: A national multicentre survey study in the Netherlands.

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.

Hyperbaric oxygen therapy for local late radiation toxicity in breast cancer patients: A systematic review.

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.

Hyperbaric oxygen therapy for the treatment of rectovaginal fistulas in patients with Crohn's disease: results of the HOT-REVA pilot study.

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.

Hyperbaric oxygen therapy for the treatment of perianal fistulas in Crohn's disease (HOT-TOPIC): study protocol of a prospective interventional cohort study with one-year follow-up.

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.

Hyperbaric oxygen therapy for dermal ischemia after dermal filler injection with calcium hydroxylapatite: a case report.

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.

Double-blind trials in hyperbaric medicine: A narrative review on past experiences and considerations in designing sham hyperbaric treatment.

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.

Quality of life in Dutch women with lichen sclerosus.

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.