Eye Movement Desensitization and Reprocessing (EMDR) treatment in the medical setting: a systematic review.

Background: Literature points towards the potential benefits of the application of Eye Movement and Desensitization Processing (EMDR)-therapy for patients in the medical setting, with cancer and pain being among the domains it is applied to. The field of applying EMDR-therapy for patients treated in the medical setting has evolved to such an extent that it may be challenging to get a comprehensive overview.Objective: This systematic literature review aims to evaluate the use and effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) therapy in patients treated in the medical setting.Methods: We performed a literature search following the PRISMA guidelines. Studies were included if the effectiveness of EMDR-therapy was assessed in adult patients treated in a medical setting. Excluded were patients exclusively suffering from a mental health disorder, without somatic comorbidity. A risk of bias analysis was performed. This review was registered on PROSPERO (CRD42022325238).Results: Eighty-seven studies, of which 26 (pilot)-RCTs were included and categorized in 14 medical domains. Additionally, three studies focusing on persistent physical complaints were included. Most evidence exists for its application in the fields of oncology, pain, and neurology. The overall appraisal of these studies showed at least moderate to high risks of bias. EMDR demonstrated effectiveness in reducing symptoms in 85 out of 87 studies. Notably, the occurrence of adverse events was rarely mentioned.Conclusions: Overall, outcomes seem to show beneficial effects of EMDR on reducing psychological and physical symptoms in patients treated in a medical setting. Due to the heterogeneity of reported outcomes, effect sizes could not be pooled. Due to the high risk of bias of the included studies, our results should be interpreted with caution and further controlled high-quality research is needed.

First overview on the use of EMDR for adult patients treated in the medical setting.EMDR seems beneficial in improving psychological and physical symptoms.Given the heterogeneity of studies and high risk of bias, further controlled studies are needed in this field.

Cancer centre information and support services and patient needs: participatory action research study.

OBJECTIVES: Clear information and supportive care are necessary for oncology patients and their relatives to manage the disease (trajectory). Centres for information and support aim to address their needs by offering informal and non-medical formal services. This study evaluated whether the centres' services offered meet the needs of its visitors, and whether there is interest for these among oncology patients treated at affiliated hospitals. METHODS: In this participatory action research, interviews were conducted among visitors of two centres (Patient Information Center Oncology (PATIO) and IntermeZZo) and among patients treated at the affiliated hospitals. Visitors were interviewed to share their experiences regarding the centres' services offered. Patients from the hospitals were interviewed about their interest in such support. Data were collected during three different periods and adjustments were made to the centres' services between measurements. RESULTS: 111 (PATIO) and 123 visitors (IntermeZZo) were interviewed, and 189 and 149 patients at the respective hospitals. Reasons to visit PATIO/IntermeZZo were to relax (93.1%), seek professional advice (54.6%) and meet peers (36.3%). Visitors indicated that the visits met their needs (99.1%), citing the accessible support and the expertise in oncology. 20% of patients interviewed at the hospitals expressed interest in visiting PATIO/IntermeZZo. The majority of patients (89.6%) considered these centres an integral part of their treatment process. These findings were stable over time. CONCLUSIONS: Patients and their relatives highly value the services of hospital-affiliated centres for information and support. Future research should address how such centres best be integrated in the Dutch healthcare system.

Psychosocial screening instruments to assist support consultants in patients with cancer.

OBJECTIVES: Around 30% of patients with cancer suffer from psychosocial problems requiring formal care; however, these problems are often not identified. Support consultants may play a role in identifying these problems. This study investigates the feasibility of using validated screening instruments to assist support consultants in identifying psychosocial problems. METHODS: Prospective observational study focusing on patients visiting support consultants at hospital-affiliated centres for information and support. The feasibility of using screening instruments was assessed based on the percentage of patients willing to participate. For these patients, possible psychosocial problems were objectified, and referral to formal care was assessed. RESULTS: Out of 227 eligible patients at IntermeZZo, 48 participated (21.1%). At PATIO, over 141 consultations took place and 27 patients participated. Main reason for non-participation was that patients did not feel such a need. The majority showed elevated scores, indicating possible psychosocial problems and around half were referred. Respecting the individual needs of patients and offering them with what benefits them is crucial, including screening instruments does not match their needs nor did support consultants feel it was appropriate in certain cases. CONCLUSION: Given the low percentage of questionnaires administered, it does not seem feasible to systematically administer them to patients visiting support consultants.

Unmet care needs of patients with advanced cancer and their relatives: multicentre observational study.

OBJECTIVES: The care needs of patients with advanced cancer and their relatives change throughout the disease trajectory. This study focused on the care-related problems and needs of patients with advanced cancer and their relatives. This was done from the perspective of centres for information and support. METHODS: This cross-sectional study used data from the eQuiPe study: an observational cohort study in which 40 Dutch hospitals participated. All adult patients with a diagnosis of a metastasised tumour and their relatives were eligible. Measures included information on the patients' and relatives' care problems and needs, assessed by the short version of the Problems and Needs in Palliative Care questionnaire. Socioeconomic demographics were also collected. RESULTS: 1103 patients with advanced cancer and 831 relatives were included. Both patients (M=60.3, SD=29.0) and relatives (M=59.2, SD=26.6) experienced most problems in the domain of 'psychological issues'. Both patients (M=14.0, SD=24.2) and relatives (M=17.7, SD=25.7) most frequently reported unmet needs within this domain. The most often reported unmet need by patients was 'worrying about the future of my loved ones' (22.0%); for relatives this was 'fear for physical suffering of the patient' (32.8%). There was no clear relationship between socioeconomic demographics and the experienced unmet needs. CONCLUSIONS: The most often mentioned unmet needs consisted of fears and worries, followed by a broad range of topics within multiple domains. Centres for information and support may play a role in reducing the unmet needs of (potential) visitors as these centres provide support on a broad range of topics.

Comparing measurement properties of EQ-5D-Y-3L and EQ-5D-Y-5L in paediatric patients.

BACKGROUND: The adult versions EQ-5D-3L and EQ-5D-5L have been extensive compared. This is not the case for the EQ-5D youth versions. The study aim was to compare the measurement properties and responsiveness of EQ-5D-Y-3L and EQ-5D-Y-5L in paediatric patients. METHODS: A sample of patients 8-16 years old with different diseases and a wide range of disease severity was asked to complete EQ-5D-Y-3L, EQ-5D-Y-5L, PedsQL Generic Core Scale, and selected, appropriate disease-specific instruments, three times. EQ-5D-Y-3L and EQ-5D-Y-5L were compared in terms of: feasibility, (re-)distribution properties, discriminatory power, convergent validity, test-retest reliability, and responsiveness. RESULTS: 286 participating patients suffered from one of the following diseases: major beta-thalassemia, haemophilia, acute lymphoblastic leukaemia, acute illness. Missing responses were comparable between versions of the EQ-5D-Y, suggesting comparable feasibility. The number of patients in the best health state (level profile 11111) was equal in both EQ-5D-Y versions. The projection of EQ-5D-Y-3L scores onto EQ-5D-Y-5L for all dimensions showed that the two additional levels in EQ-5D-Y-5L slightly improved the accuracy of patients in reporting their problems, especially if severe. Convergent validity with PedsQL and disease-specific measures showed that the two EQ-5D-Y versions performed about equally. Test-retest reliability (EQ-5D-Y-3L 0.78 vs EQ-5D-Y-5L 0.84), and sensitivity for detecting health changes, were both better in EQ-5D-Y-5L. CONCLUSIONS: Extending the number of levels did not give clear superiority to EQ-5D-Y-5L over EQ-5D-Y-3L based on the criteria assessed in this study. However, increasing the number of levels benefitted EQ-5D-Y performance in the measurement of moderate to severe problems and especially in longitudinal study designs.

Improvements in PCOS characteristics and phenotype severity during a randomized controlled lifestyle intervention.

RESEARCH QUESTION: What is the effect of weight loss through different interventions (three-component lifestyle intervention with short message service [SMS+] versus three-component lifestyle intervention without SMS [SMS-] versus care as usual [CAU]) on polycystic ovary syndrome (PCOS) characteristics (ovulatory dysfunction, hyperandrogenism, polycystic ovarian morphology [PCOM]) and phenotype distribution? DESIGN: Analysis of secondary outcome measures of a randomized controlled trial. Women diagnosed with PCOS (n = 183), who wished to become pregnant, with a body mass index above 25 kg/m², were assigned to a 1-year three-component (cognitive behavioural therapy, diet, exercise) lifestyle intervention group, with or without SMS, or to CAU (advice to lose weight). RESULTS: The prevalence of biochemical hyperandrogenism was 30.9% less in the SMS- group compared with CAU after 1 year (P = 0.027). Within-group analyses revealed significant improvements in ovulatory dysfunction (SMS+: -39.8%, P = 0.001; SMS-: -30.5%, P = 0.001; CAU: -32.1%, P < 0.001), biochemical hyperandrogenism (SMS-: -27.8%, P = 0.007) and PCOM (SMS-: -14.0%, P = 0.034). Weight loss had a significantly favourable effect on the chance of having ovulatory dysfunction (estimate 0.157 SE 0.030, P < 0.001) and hyperandrogenism (estimate 0.097 SE 0.027, P < 0.001). CONCLUSIONS: All groups demonstrated improvements in PCOS characteristics, although these were more profound within the lifestyle intervention groups. Weight loss per se led to an amelioration of diagnostic characteristics and in the phenotype of PCOS. A three-component lifestyle intervention aimed at a 5-10% weight loss should be recommended for all women with PCOS before they become pregnant.

Six and eight weeks injection frequencies of bevacizumab are non-inferior to the current four weeks injection frequency for quality of life in neovascular age-related macular degeneration: a randomized controlled trial.

PURPOSE: Patients with neovascular age-related macular degeneration (nARMD) will not deteriorate on visual acuity and retinal thickness when treated with bevacizumab injection frequencies of 6 or 8 weeks compared to 4 weeks. This study aimed to investigate this non-inferiority in quality of life (QoL). We hypothesized that less frequent bevacizumab injections are not inferior regarding patients reported QoL. METHODS: Patients were randomized to bevacizumab every 4 (n = 64), 6 (n = 63), and 8 weeks (n = 64). Patients were at least 65 years old, have a best-corrected visual acuity of 20/200 to 20/20, no previous ARMD treatment and active leakage. Vision-related QoL questionnaire NEI VFQ-39 was used to assess QoL at baseline and after 1 year. General QoL questionnaire SF-36 was included for secondary analysis. Multilevel analyses were performed, correcting for age, gender and baseline. RESULTS: The 6 (3.68; 95% CI - 0.63 to 8.00) and 8 (2.15; 95% CI - 2.26 to 6.56) weeks bevacizumab regimens resulted in non-inferior QoL differences compared to 4 weeks on the NEI VFQ-39. Also on the SF-36 the differences were well within the non-inferiority limits. CONCLUSION: Non-inferiority of the 6 and 8 weeks frequencies was demonstrated compared to 4 weeks on vision-related and general QoL in patients with nARMD. These results are in line with previously published results of lower frequency injections regarding visual acuity and central retinal thickness. Lower injection frequency may reduce burden, side effects, and treatment costs. In consideration of these results, 8 weeks frequency injections of intravitreal bevacizumab could be considered in patients with nARMD.

A very short version of the Visual Function Questionnaire (VFQ-3oo7) for use as a routinely applied Patient-Reported Outcome Measure.

BACKGROUND: Patient-reported outcome measures (PROMs) are valuable supplements in regular care to facilitate routine monitoring of quality of life from the patient's perspective. The 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) is a widely used PROM in ophthalmology. However, the NEI-VFQ-25 is too time-consuming and cumbersome for routine evaluations in regular care. The aim of this study is to construct a 7-item questionnaire of which only 3 items are presented to the patient, by means of routing. This VFQ 3 out of 7 (VFQ-3oo7) should have a minimal loss of information compared with the NEI-VFQ-25. METHODS: An historical database including 3293 administrations of the NEI-VFQ-25 was constructed involving patients with retinal detachment, cataract, corneal diseases, glaucoma, macular degeneration, uveal melanoma and a normal population sample. The data were subjected to Rasch analyses, in particular a generalized partial credit model. Items were sorted on the latent trait and divided into seven categories. From each category, the item with the highest discriminative value was selected. Through routing, only three out of the seven remaining questions are used, where the answers navigate patients to a fitting trait level. RESULTS: A one-dimensional structure was considered fitting. The VFQ-3oo7 showed a small loss of information compared with the total score of the NEI-VFQ-25: correlation 0.927 and a relative precision of 0.868. CONCLUSION: The very short, but valid, VFQ-3oo7 can be applied to evaluate the patient's perceived vision-related health status in routine evaluations of treatments in regular care, with a small burden for patients.

Patients' decision-making, experiences and preferences regarding pixantrone treatment in relapsed or refractory diffuse large B-cell lymphoma: study protocol for a longitudinal mixed methods study.

INTRODUCTION: There is a lot of speculation about why and how patients decide to use invasive treatment in an advanced stage of cancer, but the body of research is limited. The present longitudinal qualitative and quantitative study reflects real-life practice of pixantrone use and aims to collect data on patients' considerations for, expectations of and experiences with pixantrone and trajectories in their quality-of-life (QoL) values in a Dutch clinical setting. Hence, two questions emerge. Why do patients choose for this treatment, while the treatment success rate is limited and curation cannot be achieved? And second, once chosen, what conditions would patients like to satisfy and how do they experience the treatment? METHODS AND ANALYSIS: This is a non-interventional longitudinal and multicentre study. Patients are eligible if they are >18 years, have never been treated with pixantrone before, have an Eastern Cooperative Oncology Group performance score ≤2, have a relapsed or refractory diffuse large B-cell lymphoma and have been treated with at least two prior regimens. The decision to treat patients with pixantrone has been taken by the treating physician before patients are asked to participate in the study. If patients refuse study participation after being informed by the investigator, reasons for refusal (if given) will be recorded. Participants will receive at least three interviews accompanied by three QOL questionnaires. Based on the required sample size, we aim to include 20 patients over a period of 2 years. ETHICS AND DISSEMINATION: The Medical Ethical Committee of Erasmus MC, Rotterdam, The Netherlands, has approved this study. The results will be disseminated in peer-reviewed journals and major international conferences. The study is non-interventional and falls therefore not under Medical Research Involving Human Subjects Act (In Dutch: Wet medisch-wetenschappelijk onderzoek met mensen; WMO). Hence, this study is approved to be carried out in the Erasmus MC. Each other participating centre will receive this approval and will separately undergo the ethical approval to be able to participate. In addition to the ethical approval, the participating centres need to obtain written informed consent of their patients. Given the non-interventional nature of this study, a study registration was considered but deemed unnecessary. The study will be conducted in accordance with the Declaration of Helsinki (Tokyo, Venice, Hong Kong and Somerset West amendments). A sequential identification number will be automatically attributed to each patient that has given consent to participate in the study. This number will identify the patient and must be included on all documents. Only the main researcher can link the code to the patient's identity.

Training for endoscopic surgical procedures should be performed in the dissection room: a randomized study.

BACKGROUND: Laparoscopic surgery is associated with a shallow learning curve. AnubiFiX embalming technique enables laparoscopic surgical training on supple embalmed and hence insufflatable human specimens in the dissection room. Aim of the present trial is to test whether dissection-based anatomy education is superior to classical frontal classroom education on the short and long term. METHODS: A total of 112 medical students were randomized in three groups. Group I attended classroom education, group II laparoscopic dissection-based education and group III received both. All groups completed an anatomy test on human specimens before, immediately after and 3 weeks after the anatomy training. RESULTS: Group II and III scored significantly better compared to group I immediately after the anatomy training (p I-II < 0.001, p I-III < 0.001). This difference was still significant after 3 weeks (p I-II < 0.001, p I-III < 0.001). No significant difference was found between group II and group III immediately after the course (p = 0.86), nor at the follow-up (p = 0.054). CONCLUSIONS: The AnubiFiX™ embalming technique enables laparoscopic anatomy education in human specimens, with superior outcomes on the short and long term, as compared to classical frontal classroom education.

Validation, test-retest reliability and norm scores for the Dutch Catquest-9SF.

PURPOSE: The Catquest-9SF questionnaire is a unidimensional, reliable, valid and short patient-reported outcome measure for quantifying benefits in visual functioning from cataract surgery. Our aim was to develop a formal Dutch translation, calculate norm scores, assess its validity and test-retest reliability and provide an easy way for use in clinical practice. METHODS: Translation of the questionnaire was performed according to guidelines of the International Society for Pharmacoeconomics and Outcomes Research. Catquest-9SF was obtained in 657 patients pre- and postcataract surgery. We applied Rasch and classical analyses to determine the questionnaire performance with characteristics such as unidimensionality, reliability, separation and differential item functioning. Test-retest reliability was assessed in another group of 145 patients. A cut-off value to discriminate between people with and without cataract, norm scores and a reliable change index (RCI) were calculated using data from a sample of 916 'healthy' persons from the normal population. RESULTS: The Dutch Catquest-9SF was unidimensional, and both person and item reliability were high; 0.87 and 0.99, respectively. Cronbach's alpha was 0.94, test-retest reliability was 0.85 and the intraclass correlation coefficient was 0.93. Catquest-9SF showed to be responsive to the effect of cataract surgery (effect size = 1.27; p < 0.001). The cut-off value was -1.90, and RCI was 2.27. A quick-access table with norm scores and percentiles was established to facilitate clinical interpretation. CONCLUSION: This investigation provides validity and reliability of the Dutch Catquest-9SF as well as norm scores and a new tool to facilitate the clinical interpretation of patient scores. This makes Catquest-9SF suitable for routine use in clinical practice.

What made you wait so long? Delays in presentation of retinal detachment: knowledge is related to an attached macula.

PURPOSE: In rhegmatogenous retinal detachment, the time between first symptoms and reattachment surgery is critical to prevent macular detachment. We explored which determinants discriminate between 'macula-ON' and 'macula-OFF' retinal detachments to improve timely treatment. METHODS: Eight-hundred patients with rhegmatogenous retinal detachment admitted for surgery at the Rotterdam Eye Hospital in the Netherlands were eligible to complete a questionnaire to explore the following determinants: (i) patient's delay and doctor's delay; (ii) patient-reported causes for delay; (iii) symptoms as early warning signals; (iv) patient's prior knowledge about retinal detachment; and (v) trait anxiety. RESULTS: Five hundred and twenty-one questionnaires (65%) were analysed. Median interval between first symptoms and surgery was 14 days. Macula-ON/OFF ratio was 46/54. Patient's delay in macula-ON patients (median 3 days) was shorter than in macula-OFF (5 days, p = 0.026). No difference was found in doctor's delay except for 'waiting time for surgery': macula-ON patients were operated on faster (median 1 day) than macula-OFF (median 5 days, p < 0.001). Macula-ON patients more often attributed symptoms to retinal problems. Except floaters, no symptoms were determined as early warning signals for macula-ON. Macula-ON patients more often reported knowing that prognosis would be worse when treated later, even when controlled for previous experience with retinal detachment. CONCLUSION: Macula-ON patients seem to self-refer faster to a healthcare provider, seem more sensitive to floaters and seem more informed. This suggests that increasing awareness, especially about floaters, might increase the proportion of patients with macula still on at the moment of referral to the ophthalmologist.

The impact of the donors' and recipients' medical complications on living kidney donors' mental health.

A minority of living kidney donors (between 5-25%) have poor psychological outcomes after donation. There is mixed evidence on the influence of medical complications on these outcomes. We examined whether medical complications among donors and recipients predicted changes in donors' mental health (psychological symptoms and well-being) between predonation and 1 year postdonation. One-hundred and forty-five donors completed questionnaires on mental health predonation and 3 and 12 months postdonation. Number of recipient rehospitalizations and donor complications (none; minor; or severe) were obtained from medical records at 3 and 12 months after surgery. Multilevel regression analyses were used to examine the association between medical complications and changes in donors' mental health over time after controlling for sociodemographic characteristics. We found that donor complications (P = 0.003) and recipient rehospitalizations (P = 0.001) predicted an increase in donors' psychological symptoms over time. Recipient rehospitalizations also predicted a decrease in well-being (P = 0.005) over time; however, this relationship became weaker over time. We conclude that medical complications experienced by either the donor or recipient is a risk factor for deterioration in donors' mental health after living kidney donation. Professionals should monitor donors who experience medical complications and offer additional psychological support when needed.

Standardised mindfulness-based interventions in healthcare: an overview of systematic reviews and meta-analyses of RCTs.

BACKGROUND: Mindfulness-based therapies are being used in a wide range of common chronic conditions in both treatment and prevention despite lack of consensus about their effectiveness in different patient categories. OBJECTIVE: To systematically review the evidence of effectiveness MBSR and MBCT in different patient categories. METHODS: A systematic review and meta-analysis of systematic reviews of RCTs, using the standardized MBSR or MBCT programs. We used PRISMA guidelines to assess the quality of the included reviews and performed a random effects meta-analysis with main outcome measure Cohen's d. All types of participants were considered. RESULTS: The search produced 187 reviews: 23 were included, covering 115 unique RCTs and 8,683 unique individuals with various conditions. Compared to wait list control and compared to treatment as usual, MBSR and MBCT significantly improved depressive symptoms (d=0.37; 95%CI 0.28 to 0.45, based on 5 reviews, N=2814), anxiety (d=0.49; 95%CI 0.37 to 0.61, based on 4 reviews, N=2525), stress (d=0.51; 95%CI 0.36 to 0.67, based on 2 reviews, N=1570), quality of life (d=0.39; 95%CI 0.08 to 0.70, based on 2 reviews, N=511) and physical functioning (d=0.27; 95%CI 0.12 to 0.42, based on 3 reviews, N=1015). Limitations include heterogeneity within patient categories, risk of publication bias and limited long-term follow-up in several studies. CONCLUSION: The evidence supports the use of MBSR and MBCT to alleviate symptoms, both mental and physical, in the adjunct treatment of cancer, cardiovascular disease, chronic pain, depression, anxiety disorders and in prevention in healthy adults and children.

Exploring Knowledge About Dialysis, Transplantation, and Living Donation Among Patients and Their Living Kidney Donors.

BACKGROUND: In order to make a well-considered decision and give informed consent about renal replacement therapy, potential living kidney donors and recipients should have sufficient understanding of the options and risks. PURPOSE: We aimed to explore knowledge about Dialysis & Transplantation (DT) and Living Donation (LD) among prospective living kidney donors and recipients. METHODS: Eighty-five donors and 81 recipients completed the Rotterdam Renal Replacement Knowledge-Test (R3K-T) 1 day before surgery. The questionnaire was available in various languages. RESULTS: Recipients knew significantly more about DT than donors (p < 0.001); donors knew more about LD than recipients (p < 0.001). A minority of donors (15 %) and recipients (17 %) had a score that was comparable to the knowledge level of the naïve general population. Recipients and donors knew less about DT and LD if their native language was not Dutch. In addition, recipients knew less about DT if they were undergoing pre-emptive transplantation. CONCLUSIONS: We conclude that recipients and donors retain different information. The decision to undergo living donation appears to be not always based on full knowledge of the risks. We recommend that professionals assess knowledge of prospective donors and recipients during the education process using the R3K-T, and extra attention is required for non-native speakers.

Anatomy education and classroom versus laparoscopic dissection-based training: a randomized study at one medical school.

PURPOSE: Anatomy education on embalmed specimens is presumed to have added educational value. However, although embalmed specimens have been used for anatomy education for years, there is little evidence on the added educational value of dissection-based teaching. The objective of this randomized study is to examine the added value of dissection-based teaching, using models of the inguinal region in embalmed specimens. METHOD: In 2011, medical students at Erasmus Medical Center, The Netherlands, were randomly assigned to three groups. Group I attended lectures, group II attended dissection-based training using laparoscopic dissection models, and group III attended lectures as well as dissection-based laparoscopic training. To assess the improvement of anatomical knowledge, all students had to complete a practical test before, immediately after, and two weeks after training. Data were analyzed with mixed modeling. RESULTS: Forty-six students participated in this study. No significant difference in results was observed among the three groups before the start of training. Immediately after the course, groups II and III scored significantly higher than group I (P < .001; P < .001), and group II scored higher than group III (P = .009). The difference between group I and groups II and III persisted during follow-up (P = 012; P = .001). The difference between groups II and III disappeared. CONCLUSIONS: Three-dimensional anatomy education with dissection models enhances anatomy learning by medical students. Students who received dissection-based training scored higher in the short- and long term compared with students who did not receive this type of education.

Towards patient self-triage in the ophthalmic emergency department: sensitivity and specificity of a self-triage instrument.

PURPOSE: Trained ophthalmic triage staff may not constantly be available in the emergency department of a specialized ophthalmic hospital, particularly at night. To support the current triage process, the aim of this study was to develop an ophthalmic instrument of patient self-triage (ISET). METHODS: A preliminary ISET, in the form of a pen-and-paper questionnaire, was refined and validated in a two-step procedure. In a first explorative step, we compared the results of the ISET with the results of the regular triage process during the day, that is, triage by a trained triage assistant in a specialized ophthalmic hospital. As several patients needed guidance completing the questionnaire, the ISET was subsequently refined. The second step was to test the validity of the refined ISET by again comparing the outcome of this triage with that of the triage assistant in the emergency department. RESULTS: The first explorative step involved 279 patients and the final validation step 298. During the validation step, sensitivity of the ISET was 94.3% and specificity 76.4%. CONCLUSION: The results show that the ISET is a sensitive and specific instrument for ophthalmic triage compared with a trained ophthalmic triage assistant.

Intralesional cryotherapy versus excision and corticosteroids or brachytherapy for keloid treatment: study protocol for a randomised controlled trial.

BACKGROUND: Keloids are a burden for patients due to physical, aesthetic and social complaints and treatment remains a challenge because of therapy resistance and high recurrence rates. The main goal of treatment is to improve the quality of life (QoL); this implies that, apart from surgical outcomes, patient-reported outcome measures (PROMs) need to be taken into account. Decision making in keloid treatment is difficult due to heterogeneity of the condition and the lack of comparative studies. METHODS/DESIGN: This is a multicentre, randomised controlled open trial that compares 1) intralesional cryotherapy versus excision and corticosteroids for primary keloids, and 2) intralesional cryotherapy versus excision and brachytherapy for therapy-resistant keloids. The primary outcome is the Patient and Observer Scar Assessment Scale (POSAS), a 12-item scale (with score 12 indicating the best and 120 indicating the worst scar imaginable). A difference of six points on the total score is considered to be of clinical importance. Secondary outcomes are recurrence rates, volume reduction, Skindex-29 scores, SF-36 scores and complication rates. Primary and secondary outcome measurements are taken at baseline, and at 2, 12, 26 and 52 weeks postoperatively. For analysis, a linear mixed model is used. A total of 176 patients will be included over a period of 2.5 years. The protocol is approved by the Medical Ethics Committee of the Erasmus University Medical Centre Rotterdam and follows good clinical practice guidelines. DISCUSSION: The outcomes of this study will improve evidence-based decision making for the treatment of keloids, as well as patient education. TRIAL REGISTRATION: Dutch Trial Register NTR4151.