Background Patient-reported outcome measures (PROMs) are important in clinical practice and research. The growth of electronic health technologies provides unprecedented opportunities to systematically collect information via PROMs. Objective The aim of this study was to provide an objective and comprehensive overview of the benefits, barriers, and disadvantages of the digital collection of qualitative electronic patient-reported outcome measures (ePROMs). Methods We performed a systematic review of articles retrieved from PubMED and Web of Science. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed during all stages. The search strategy yielded a total of 2333 records, from which 32 met the predefined inclusion and exclusion criteria. The relevant ePROM-related information was extracted from each study. Results Results were clustered as benefits and disadvantages. Reported benefits of ePROMs were greater patient preference and acceptability, lower costs, similar or faster completion time, higher data quality and response rates, and facilitated symptom management and patient-clinician communication. Tablets were the most used ePROM modality (14/32, 44%), and, as a platform, Web-based systems were used the most (26/32, 81%). Potential disadvantages of ePROMs include privacy protection, a possible large initial financial investment, and exclusion of certain populations or the “digital divide.” Conclusions In conclusion, ePROMs offer many advantages over paper-based collection of patient-reported outcomes. Overall, ePROMs are preferred over paper-based methods, improve data quality, result in similar or faster completion time, decrease costs, and facilitate clinical decision making and symptom management. Disadvantages regarding ePROMs have been outlined, and suggestions are provided to overcome the barriers. We provide a path forward for researchers and clinicians interested in implementing ePROMs. Trial Registration PROSPERO CRD42018094795; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=94795
Introduction: A wide variety of non-invasive treatments has been proposed for the management of hypertrophic burn scars. Unfortunately, the reported efficacy has not been consistent, and especially in the first three months after wound closure, fragility of the scarred skin limits the treatment options. Extracorporeal shock wave therapy (ESWT) is a new non-invasive type of mechanotherapy to treat wounds and scars. The aim of the present study was to examine the objective and subjective scar-related effects of ESWT on burn scars in the early remodelling phase. Material and methods: Evaluations included the Patient and Observer Scar Assessment Scale (POSAS) for scar quality, tri-stimulus colorimetry for redness, tewametry for trans-epidermal water loss (TEWL) and cutometry for elasticity. Patients were randomly assigned to one of two groups, the low-energy intervention group or the placebo control group, and were tested at baseline, after one, three and six months. All patients were treated with pressure garments, silicone and moisturisers. Both groups received the ESWT treatment (real or placebo) once a week for 10 weeks. Results: Results for 20 patients in each group after six months are presented. The objective assessments showed a statistically significant effect of ESWT compared with placebo on elasticity ( P = 0.011, η2 P=0.107) but revealed no significant effects on redness and TEWL. Results of the clinical assessments showed no significant interactions between intervention and time for the POSAS Patient and Observer scores. Conclusion: ESWT can give added value to the non-invasive treatment of hypertrophic scars, more specifically to improve elasticity when the treatment was already started in the first three months after wound closure. Lay Summary Pathological scarring is a common problem after a burn injury. A wide variety of non-invasive treatments has been proposed for the management of these scars. Unfortunately, the reported efficacy of these interventions has not been consistent, and especially in the first three months after wound closure, fragility of the scarred skin limits the treatment options. Extracorporeal shock wave therapy (ESWT) is a relatively new non-invasive therapy to treat both wounds and scars. The aim of the present study was to examine the scar-related effects of ESWT on burn scars in the early phase of healing. The scars were subjectively assessed for scar quality by the patient and an observer using the Patient and Observer Scar Assessment Scale (POSAS). Objective assessments included measurements to assess redness, water loss and elasticity. Forty patients were randomly assigned to one of two groups, the low-energy intervention group or the placebo control group (the device simulated the sound of an ESWT treatment but no real shocks were applied), and were tested at four timepoints up to six months. All patients were treated with pressure garments, silicone and moisturisers. Both groups received the ESWT treatment (real or placebo) once a week for 10 weeks. The objective assessments showed a significant improvement of elasticity in the intervention group when compared with placebo but revealed no significant effects on redness and water loss. Results of the clinical assessments showed no differences between the groups for the POSAS Patient and Observer scores. ESWT can give added value to the non-invasive treatment of pathological scars more specifically to improve elasticity in the early phase of healing.
PurposeTo investigate the concurrent, face and content validity of an evaluation tool for Myofascial Adhesions in Patients after Breast Cancer (MAP-BC evaluation tool).Methods1) Concurrent validity of the MAP-BC evaluation tool was investigated by exploring correlations (Spearman’s rank Correlation Coefficient) between the subjective scores (0 –no adhesions to 3 –very strong adhesions) of the skin level using the MAP-BC evaluation tool and objective elasticity parameters (maximal skin extension and gross elasticity) generated by the Cutometer Dual MPA 580. Nine different examination points on and around the mastectomy scar were evaluated. 2) Face and content validity were explored by questioning therapists experienced with myofascial therapy in breast cancer patients about the comprehensibility and comprehensiveness of the MAP-BC evaluation tool.Results1) Only three meaningful correlations were found on the mastectomy scar. For the most lateral examination point on the mastectomy scar a moderate negative correlation (-0.44, p = 0.01) with the maximal skin extension and a moderate positive correlation with the resistance versus ability of returning or ‘gross elasticity’ (0.42, p = 0.02) were found. For the middle point on the mastectomy scar an almost moderate positive correlation with gross elasticity was found as well (0.38, p = 0.04) 2) Content and face validity have been found to be good. Eighty-nine percent of the respondent found the instructions understandable and 98% found the scoring system obvious. Thirty-seven percent of the therapists suggested to add the possibility to evaluate additional anatomical locations in case of reconstructive and/or bilateral surgery.ConclusionsThe MAP-BC evaluation tool for myofascial adhesions in breast cancer patients has good face and content validity. Evidence for good concurrent validity of the skin level was found only on the mastectomy scar itself.
The Corneometer CM825(®) is an objective and sensitive instrument for water content measurements. On the basis of our results, we concluded that the instrument can be used in clinical trials, but only under very strict conditions with standardized test protocol, preferably in combination with the evaluation of other physiological parameters.
BackgroundVacuum massage is a non-invasive mechanical massage technique invented to treat burns and scars. To date, no effects of vacuum massage on thickness and density of human scar tissue have been reported. The process in which external stimuli are converted into biochemical responses in the cell is known as mechanotransduction. In the skin endothelial cells, fibroblasts and myofibroblasts embedded in the extracellular matrix (ECM) sense mechanical stimuli (created by vacuum massage) and may promote intracellular processes leading to matrix remodelling. Since mechanotransduction could be a plausible working mechanism for vacuum massage as an anti-scarring therapy, this study aims to investigate the short-term effects of vacuum massage on thickness and density of epidermis and dermis in burn scars in order to find proof of ECM remodelling.MethodsA one group experimental study was performed. Patients with burn scars on upper extremities, lower extremities, and trunk were recruited for participation in this study. The DUB®cutis 22 MHz ultrasound scanner was used to assess thickness and density of the epidermal and dermal skin layers. After baseline measurements, vacuum massage was performed according to a pre-defined protocol. Measurements were carried out at 5 min, 30 min, 1 h, and 2 h post-intervention.ResultsThirteen scar sites from 9 different patients were investigated. In 8 out of the 13 scar sites, a disruption of the epidermis was noticed after the vacuum massage. Five minutes after the intervention, epidermal density decreased statistically significantly (p = .022) and dermal thickness increased (p = .018). Both changes lasted for more than 1 h, but after 2 h, the changes were no longer statistically significant. Dermal density decreased significantly (p = .048) immediately after the intervention, and this decrease was still present after 2 h (p = .011).ConclusionsPreliminary results show that the disruption of the epidermis may indicate that vacuum massage could be able to actually breach the skin barrier. The statistically significant changes in the dermal layers could suggest an increased ECM production after vacuum massage.
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