Generating utilities for the CS-Base: a novel, generic, and patient-centered health-outcome measure.

OBJECTIVES: We have developed a new patient-centered, preference-based generic health-outcome measure, CS-Base, which is based on a novel multi-attribute preference response (MAPR) measurement framework. This study aimed to generate a first utility set for the CS-Base, making it suitable for use in health-economic evaluations. METHODS: CS-Base comprises 12 health attributes: mobility, vision, hearing, cognition, mood, anxiety, pain, fatigue, social functioning, daily activities, self-esteem, and independence, each with four levels. Our methodology to generate utilities for the CS-Base was twofold. First, we derived coefficients from patient MAPR data to calculate CS-Base values. Subsequently, these were normalized to a 0.0-1.0 utility scale, where 0.0 signifies "dead". The "dead" position was estimated using general population data from a discrete choice experiment (DCE+Dead), using a "division value" strategy which localize the position of states better or worse than dead. RESULTS: We analyzed MAPR data from 3,222 patients and DCE+Dead data from 1,995 respondents. All MAPR coefficients were negative, logically ordered, and significantly different from the reference level. The "dead" position was denoted by a division value of -148.385. Utility values spanned from -0.071 to 1.0, and only 53 of 16,777,216 states were deemed worse than dead. CONCLUSION: This study introduced the first CS-Base utility set, underlining a two-step utility derivation method. This method, blending societal and patient views, surpasses traditional preference-based approaches, yielding firmer results. However, improvement of the normalization procedure is expected. Estimating CS-Base utilities is an ongoing process that gains precision over time.

Methylation Analysis to Detect CIN3+ in High-Risk Human Papillomavirus-Positive Self-Samples From the Population-Based Cervical Cancer Screening Program.

Since 2017, a self-sampling device has been introduced to the Dutch population-based screening program to enable higher participation rates. However, routine triage cytology cannot be performed on self-sampling material. Methylation is an alternative triage method that can be performed directly on DNA extracted from self-samples. Recently, we tested a set of 15 published cervical intraepithelial neoplasia grade 3 or worse (CIN3+)-specific methylation markers and found a panel of 3 markers with a sensitivity of 82% and a specificity of 74%. In this study, we determined the sensitivity and specificity of 2 commercial assays using quantitative methylation-specific PCR. DNA from the same cohort of high-risk human papillomavirus-positive self-sampled material obtained through the population-based screening program in the North of the Netherlands from women with CIN2 or less (

Sinonasal inverted papilloma and predictors of health-related quality of life after endonasal endoscopic surgery: A prospective cohort study.

OBJECTIVES: Existing knowledge on health-related quality of life (HRQoL) after surgical removal of sinonasal inverted papilloma (IP) is limited. Moreover, predictors for a better or worse post-operative HRQoL outcome are not known. Our aim was to assess HRQoL in all three health domains (physical, psychological, and social), track its post-operative trajectory, investigate if pre-operative observations could predict distinct post-operative HRQoL outcomes, and evaluate whether physicians' interventions could contribute to improved post-operative HRQoL. DESIGN: Prospective cohort study. SETTING: Tertiary referral hospital. PARTICIPANTS: Seventy-four patients who underwent surgery for an IP were included. They were asked to fill in the Endonasal Endoscopic Sinus and Skull-Base Surgery Questionnaire (EES-Q) pre-operatively, and then 2 weeks, 3 months, and 1 year post-operatively. MAIN OUTCOME MEASURES: Linear mixed models analyses were performed to evaluate the overall post-operative HRQoL and the separate health domains, as well as the impact of specific variables (sex, age, American Society of Anaesthesiologists [ASA] classification, smoker, Krouse staging, pre-operative EES-Q score, type of surgery, and post-operative antibiotics) on HRQoL improvement. RESULTS: The total EES-Q score (p < .001) as well as the physical (p < .001), psychological (p = .049), and the social (p = .002) domains significantly improved post-operatively. ASA classification (p = .049), pre-operative EES-Q score (p < .001) and post-operative antibiotics (p = .036) were significant variables. CONCLUSIONS: Overall HRQoL, as well as each of the three health domains, improved significantly. A higher ASA score, a higher pre-operative EES-Q score, and the administration of post-operative antibiotics were significant predictors for better HRQoL recovery post-operatively. Further research is necessary to confirm these results.

Reliability, costs, and radiation dose of dual-energy X-ray absorptiometry in diagnosis of radiologic sarcopenia in surgically menopausal women.

OBJECTIVE: The aim of this study was to evaluate and compare reliability, costs, and radiation dose of dual-energy X-ray absorptiometry (DXA) to MRI and CT in measuring muscle mass for the diagnosis of sarcopenia. METHODS: Thirty-four consecutive DXA scans performed in surgically menopausal women from November 2019 until March 2020 were analyzed by two observers. Observers analyzed muscle mass of the lower limbs in every scan twice. Reliability was assessed by calculating inter- and intra-observer variability. Reliability from CT and MRI as well as radiation dose from CT and DXA were collected from literature. Costs for each type of scan were calculated according to the guidelines for economic evaluation of the Dutch National Health Care Institute. RESULTS: The 34 participants had a median age of 58 years (IQR 53-65) and a median body mass index of 24.6 (IQR 21.7-29.7). Inter-observer variability had an intraclass correlation coefficient (ICC) of 0.997 (95% CI 0.994-0.998) with a relative variability of 0.037 ± 0.022%. Regarding intra-observer variability, observer 1 had an ICC of 0.998 (95% CI 0.996-0.999) with a relative variability of 0.019 ± 0.016% and observer 2 had an ICC of 0.997 (95% CI 0.993-0.998) with a relative variability of 0.016 ± 0.011%. DXA costs were €62, CT €77, and MRI €195. The estimated radiation dose of CT was 2.5-3.0 mSv, for DXA this was 2-4 µSv. CONCLUSIONS: DXA has lower costs and a lower radiation dose, with low inter- and intra-observer variability, compared to CT and MRI for assessing lower limb muscle mass. TRIAL REGISTRATION: Netherlands Trial Register; NL8068. CRITICAL RELEVANCE STATEMENT: DXA is a good alternative for CT and MRI in assessing lower limb muscle mass, with lower costs and lower radiation dose, while inter-observer and intra-observer variability are low. KEY POINTS: • Screening for sarcopenia should be optimized as the population ages. • DXA outperformed CT and MRI in the measured metrics. • DXA validity should be further evaluated as an alternative to CT and MRI for sarcopenia evaluation.

Different Frameworks, Similar Results? Head-to-Head Comparison of the Generic Preference-Based Health-Outcome Measures CS-Base and EQ-5D-5L.

OBJECTIVE: We compared two generic, preference-based health-outcome measures: the novel patient-centered Château-Santé Base (CS-Base), entailing a multi-attribute preference response framework, and the widely used EQ-5D-5L, regarding effects of different measurement frameworks and different descriptive systems. METHODS: We conducted a cross-sectional study using a random sample of patients (3019 reached, 1988 included) in the USA with various health conditions. The CS-Base (12 attributes, each with four levels), EQ-5D-5L and the 5D-4L (an ad hoc, multi-attribute preference response-based measure that includes five attributes similar to the EQ-5D-5L, but with four levels) were used as health-outcome measures. We compared the proportions of problems reported on health attributes, statistical robustness and face validity of coefficients, attribute importance, differentiation between health states based on health-state values obtained with these measures, and user experience. RESULTS: All the CS-Base and 5D-4L coefficients had logical orders and significant differences from the reference level (p < 0.001). Substantial differences were observed in the CS-Base and 5D-4L coefficients between all levels on all attributes, while subtle differences were seen in those of the EQ-5D-5L. Attribute importance of usual (daily) activities were lowest or second lowest in all the three health-outcome measures. Attributes with the highest importance in the CS-Base, 5D-4L, and EQ-5D-5L were respectively mobility, anxiety/depression, and pain/discomfort. Four attributes are similar between the CS-Base and EQ-5D-5L, eight are exclusive to CS-Base. Of the eight, vision and hearing had the highest importance. Health-state values showed a smoother distribution with minimal discontinuity in the CS-Base and EQ-5D-5L than in the 5D-4L. In user experience evaluation, both CS-Base and the 5D-4L showed mean scores above 50 (indicating positive evaluation) in terms of the description of health and ease of understanding. CONCLUSIONS: This study demonstrated that CS-Base and 5D-4L, which are grounded in the multi-attribute preference response framework, produced statistically robust coefficients, with better face validity than those for the EQ-5D-5L. CS-Base and the EQ-5D-5L outperformed the 5D-4L in differentiating between health states. Notwithstanding differences in content, measurement frameworks, and estimated coefficients, the computed health-state values were similar between CS-Base and EQ-5D-5L.

Impact of health-related behavioral factors on participation in a cervical cancer screening program: the lifelines population-based cohort.

BACKGROUND: Regular participation in cervical cancer screening is critical to reducing mortality. Although certain sociodemographic factors are known to be associated with one-time participation in screening, little is known about other factors that could be related to regular participation. Therefore, this study evaluated the association between health-related behavioral factors and regular participation in cervical cancer screening. METHODS: The Lifelines population-based cohort was linked to data for cervical cancer screening from the Dutch Nationwide Pathology Databank. We included women eligible for all four screening rounds between 2000 and 2019, classifying them as regular (4 attendances), irregular (1-3 attendances), and never participants. Multinomial logistic regression was performed to evaluate the association between behavioral factors and participation regularity, with adjustment made for sociodemographic factors. RESULTS: Of the 48,325 included women, 55.9%, 35.1%, and 9% were regular, irregular, and never screening participants. After adjustment for sociodemographic factors, the likelihood of irregular or never screening participation was increased by smoking, obesity, marginal or inadequate sleep duration, alcohol consumption and low physical activity, while it was decreased by hormonal contraception use. CONCLUSION: An association exists between unhealthy behavioral factors and never or irregular participation in cervical cancer screening.

A care substitution service in the Netherlands: impact on referral, cost, and patient satisfaction.

BACKGROUND: In care substitution services, medical specialists offer brief consultations to provide general practitioners (GPs) with advice on diagnosis, treatment, or hospital referral. When GPs serve as gatekeepers to secondary care, these regional services could reduce pressures on healthcare systems. The aim is to determine the impact of implementing a care substitution service for dermatology, orthopaedics, and cardiology on the hospital referral rate, health care costs, and patient satisfaction. METHODS: A before-after study was used to evaluate hospital referral rates and health care costs during a follow-up period of 1 year. The study population comprised patients with eligible International Classification of Primary Care codes for referral to the care substitution service (only dermatology, orthopaedic, cardiology indications), as pre-defined by GPs and medical specialists. We compared referral rates before and after implementation by χ2 tests and evaluated patient preference by qualitative analysis. RESULTS: In total, 4,930 patients were included, 2,408 before and 2,522 after implementation. The care substitution service decreased hospital referrals during the follow-up period from 15 to 11%. The referral rate decreased most for dermatology (from 15 to 9%), resulting in a cost reduction of €10.59 per patient, while the other two specialisms experienced smaller reductions in referral rates. Patients reported being satisfied, mainly because of the null cost, improved organisation, improved care, and positive experience of the consultation. CONCLUSIONS: The care substitution service showed promise for specialisms that require fewer hospital facilities, as exemplified by dermatology.

Health Status of US Patients With One or More Health Conditions: Using a Novel Electronic Patient-reported Outcome Measure Producing Single Metric Measures.

BACKGROUND: Most existing research studying health status impacted by morbidity has focused on a specific health condition, and most instruments used for measuring health status are neither patient-centered nor preference-based. This study aims to report on the health status of patients impacted by one or more health conditions, measured by a patient-centered and preference-based electronic patient-reported outcome measure. METHODS: A cross-sectional study was conducted among patients with one or more health conditions in the United States. A novel generic, patient-centered, and preference-based electronic patient-reported outcome measure: Château Santé-Base, was used to measure health status. Individual health state was expressed as a single metric number (value). We compared these health-state values between sociodemographic subgroups, between separate conditions, between groups with or without comorbidity, and between different combinations of multimorbidity. RESULTS: The total sample comprised 3913 patients. Multimorbidity was present in 62% of the patients. The most prevalent health conditions were pain (50%), fatigue/sleep problems (40%), mental health problems (28%), respiratory diseases (22%), and diabetes (18%). The highest (best) and lowest health-state values were observed in patients with diabetes and mental health problems. Among combinations of multimorbidity, the lowest values were observed when mental health problems were involved, the second lowest values were observed when fatigue/sleep problems and respiratory diseases coexisted. CONCLUSIONS: This study compared health status across various single, and multiple (multimorbidity and comorbidity) health conditions directly, based on single metric health-state values. The insights are valuable in clinical practice and policy-making.

Effectiveness of rehabilitation for working-age patients after a total hip arthroplasty: a comparison of usual care between the Netherlands and Germany.

BACKGROUND: Postoperative rehabilitation after primary total hip arthroplasty (p-THA) differs between the Netherlands and Germany. Aim is to compare clinical effectiveness and to get a first impression of cost effectiveness of Dutch versus German usual care after p-THA. METHODS: A transnational prospective controlled observational trial. Clinical effectiveness was assessed with self-reported questionnaires and functional tests. Measurements were taken preoperatively and 4 weeks, 12 weeks, and 6 months postoperatively. For cost effectiveness, long-term economic aspects were assessed from a societal perspective. RESULTS: 124 working-age patients finished the measurements. German usual care leads to a significantly larger proportion (65.6% versus 47.5%) of satisfied patients 12 weeks postoperatively and significantly better self-reported function and Five Times Sit-to-Stand Test (FTSST) results. German usual care is generally 45% more expensive than Dutch usual care, and 20% more expensive for working-age patients. A scenario analysis assumed that German patients work the same number of hours as the Dutch, and that productivity costs are the same. This analysis revealed German care is still more expensive but the difference decreased to 8%. CONCLUSIONS: German rehabilitation is clinically advantageous yet more expensive, although comparisons are less straightforward as the socioeconomic context differs between the two countries. TRIAL REGISTRATION: The study is registered in the German Registry of Clinical Trials (DRKS00011345, 18/11/2016).

Randomized controlled study of pain education in patients receiving radiotherapy for painful bone metastases.

BACKGROUND: Although short-course radiotherapy is an effective treatment for patients with painful bone metastases, pain is not always sufficiently controlled. We therefore investigated the additional effect of a nurse-led pain education program on pain control and quality of life (QoL). PATIENTS AND METHODS: In this multicenter study, patients with solid tumor bone metastases and a worst pain intensity of ≥5 on a 0-10 numeric rating scale (NRS) were randomized between care as usual (control-group) and care as usual plus the Pain Education Program (PEP-group). PEP consisted of a structured interview and personalized education with follow-up phone calls. Patients completed the Brief Pain Inventory, EORTC QLQ-C15-PAL and BM22 at week 0, 1, 4, 8 and 12. The primary outcome was pain control, defined as the number of patients whose worst pain intensity was <5 on a 0-10 NRS after 12 weeks. Secondary outcomes were time to reach control of pain (NRS < 5), mean worst pain and average pain, and QoL at weeks 1, 4, 8 and 12. RESULTS: Of 308 included patients, 182 (92 PEP-group) completed 12 weeks follow-up. At 12 weeks, more patients in the PEP-group (71%) compared to the control-group (52%) reported pain control (P =.008). In the PEP-group, pain control was reached earlier than in the control-group (median 29 days versus 56 days; P =.003). Mean worst and average pain decreased in both groups but decreased more in the PEP-group. QoL did not differ between the groups. CONCLUSION: The addition of PEP to care as usual for patients treated with radiotherapy for painful bone metastases resulted in less pain and faster pain control.

Home-based guided hypnotherapy for children with functional abdominal pain and irritable bowel syndrome in primary care: study protocol for a randomised controlled trial.

INTRODUCTION: Children often present to primary care with functional abdominal pain (FAP) or irritable bowel syndrome (IBS), and around half still have abdominal complaints 1 year later. Hypnotherapy is an evidence-based treatment that is used in specialist care, but it lacks evidence in primary care. This study will investigate the (cost) effectiveness of home-based guided hypnotherapy for children with FAP or IBS in primary care. METHODS AND ANALYSIS: We report the design of a pragmatic randomised controlled trial among children aged 7-17 years, diagnosed with FAP or IBS by their general practitioner (GP), with assessments over 12 months. The control group will receive care as usual (CAU) by their GP (eg, communication, education and reassurance), while the intervention group will receive CAU plus 3 months of home-based guided hypnotherapy via a website. The primary outcome will be the proportion of children with adequate relief from abdominal pain/discomfort at 12 months, analysed on an intention-to-treat basis. Secondary outcomes will include the adequacy of pain relief at 3 and 6 months, pain/discomfort severity, pain frequency and intensity, daily functioning and impact on function, anxiety and depression, pain beliefs, sleep disturbances, school absence, somatisation, and healthcare use and costs. We must include 200 children to determine a 20% difference in those with adequate relief (55% control vs 75% intervention). ETHICS AND DISSEMINATION: The Medical Ethics Review Committee of the University Medical Center Groningen, the Netherlands, approved this study (METc2020/237). The results will be disseminated to patients, GPs and other stakeholders via email, a dedicated website, peer-reviewed publications and presentations at national and international conferences. We plan to collaborate with the Dutch Society of GPs to implement the results in clinical practice. TRIAL REGISTRATION NUMBER: NCT05636358.

The effect of extended participation windows on attendance at cervical cancer screening.

Research has long since confirmed the benefits of regular cervical cancer screening (CCS) worldwide. However, some developed countries have low participation rates despite well-organized screening programs. Given that studies in Europe typically define participation in 12-month windows from an invitation, we evaluated both whether extending this defined time window could reveal the true participation rate and how sociodemographic determinants affect participation delays. This involved linking data from the Lifelines population-based cohort with CCS-related data from the Dutch Nationwide Pathology Databank and including data for 69 185 women eligible for screening in the Dutch CCS program between 2014 and 2018. We then estimated and compared the participation rates for 15- and 36-month time windows and categorized women by the primary screening window into timely participation (within 15 months) and delayed participation (within 15-36 months) groups, before performing multivariable logistic regression to evaluate the association between delayed participation and the sociodemographic determinants. Participation rates for the 15- and 36-month windows were 71.1% and 77.0%, respectively, with participation considered timely in 49 224 cases and delayed in 4047 cases. Delayed participation was associated with age 30-35 years (odds ratio [OR]: 2.88, 95 %CI: 2.67-3.11), higher education (OR: 1.50, 95 %CI: 1.35-1.67), the high-risk human papillomavirus test-based program (OR: 1.67, 95 %CI: 1.56-1.79), and pregnancy (OR: 4.61, 95 %CI: 3.88-5.48). These findings show that a 36-month window for monitoring attendance at CCS better reflects the actual participation rate by accommodating possible delayed uptake among younger, pregnant, and highly educated women.

Prospective evaluation of multidimensional health-related quality of life after endoscopic endonasal surgery for pituitary adenomas using the endoscopic endonasal sinus and skull base surgery questionnaire.

Objective: Social functioning is an important factor in the evaluation of postoperative health-related quality of life (HRQoL) for pituitary adenoma patients. In a prospective cohort study multidimensional HRQoL of non-functioning (NFA) and functioning (FA) pituitary adenoma patients were evaluated following endoscopic endonasal surgery using the endoscopic endonasal sinus and skull base surgery questionnaire (EES-Q). Methods: Prospectively, 101 patients were included. The EES-Q was completed preoperatively and postoperatively (2 weeks, 3 months, 1 year). Sinonasal complaints were completed daily during the first week postoperatively. Preoperative and postoperative scores were compared. A generalized estimating equation (uni- and multivariate) analysis was performed to identify significant HRQoL changes related to selected covariates. Results: Two weeks postoperatively, physical (p < .05) and social (p < .05) HRQoL are worse and psychological (p < .05) HRQoL improved compared with preoperatively. Three months postoperatively, psychological HRQoL (p = .01) trended back to baseline and no differences in physical or social HRQoL were reported. One year postoperatively, psychological (p = .02) and social (p = .04) HRQoL improved while physical HRQoL remained stable. FA patients report a worse HRQoL preoperatively (social, p < .05) and 3 months postoperatively (social, p < .02 and psychological, p < .02). Sinonasal complaints peak in the first days postoperatively and gradually return to presurgical levels 3 months postoperatively. Conclusions: The EES-Q provides meaningful information on multidimensional HRQoL to improve patient-centred health care. Social functioning remains the most difficult area in which to achieve improvements. Despite the relatively modest sample size, there is some indication that the FA group continues to show a downward trend (and thus improvement) even after 3 months, when most other parameters reach stability. Level of evidence: Level II-B.

Nd:YAG laser capsulotomy rates in the Netherlands: practice variation and association with physician practice styles.

PURPOSE: To determine the practice variation in the rate of Nd:YAG laser capsulotomy within 1 year after cataract surgery and to identify possible associations with physician practice styles. SETTING: All hospitals and private clinics in the Netherlands. DESIGN: Retrospective observational study. METHODS: In the national medical claims database, we identified all laser capsulotomies performed in the Netherlands within a year after cataract surgery in the years 2016 and 2017. Centers with the lowest and highest percentages of Nd:YAG laser capsulotomies were interviewed on their physician practice styles related to the development of posterior capsule opacification. RESULTS: The incidence of Nd:YAG laser capsulotomy varied between 1.2% and 26.0% in 2016 (median 5.0%) and between 0.9% and 22.7% in 2017 (median 5.0%). The rate of capsulotomy was highly consistent over time for each center (Pearson correlation coefficient, 0.89, P < .001). In general, ophthalmology centers with a high rate of Nd:YAG laser capsulotomy more often did not (routinely) polish the posterior lens capsule, performed cortex removal with coaxial irrigation/aspiration (I/A, instead of bimanual), and more often used hydrophilic intraocular lenses (IOLs) (compared with only using hydrophobic IOLs). CONCLUSIONS: We found a significant practice variation in performing Nd:YAG laser capsulotomy within 1 year after cataract surgery in the Netherlands. Routinely polishing the posterior capsule, using bimanual I/A, and the use of hydrophobic IOLs are associated with a lower incidence in Nd:YAG laser capsulotomy. Incorporating these practice styles may lower the practice variation and thus prevent added medical burden for the patient and decrease costs.

Health-related quality of life, one-year costs and economic evaluation in extracorporeal membrane oxygenation in critically ill adults.

PURPOSE: This study reports on survival and health related quality of life (HRQOL) after extracorporeal membrane oxygenation (ECMO) treatment and the associated costs in the first year. MATERIALS AND METHODS: Prospective observational cohort study patients receiving ECMO in the intensive care unit during August 2017 and July 2019. We analyzed all healthcare costs in the first year after index admission. Follow-up included a HRQOL analysis using the EQ-5D-5L at 6 and 12 months. RESULTS: The study enrolled 428 patients with an ECMO run during their critical care admission. The one-year mortality was 50%. Follow up was available for 124 patients at 12 months. Survivors reported a favorable mean HRQOL (utility) of 0.71 (scale 0-1) at 12 months of 0.77. The overall health status (VAS, scale 0-100) was reported as 73.6 at 12 months. Mean total costs during the first year were $204,513 ± 211,590 with hospital costs as the major factor contributing to the total costs. Follow up costs were $53,752 ± 65,051 and costs of absenteeism were $7317 ± 17,036. CONCLUSIONS: At one year after hospital admission requiring ECMO the health-related quality of life is favorable with substantial costs but considering the survival might be acceptable. However, our results are limited by loss of follow up. So it may be possible that only the best-recovered patients returned their questionnaires. This potential bias might lead to higher costs and worse HRQOL in a real-life scenario.

The C4EB study-Transvamix (10% THC / 5% CBD) to treat chronic pain in epidermolysis bullosa: A protocol for an explorative randomized, placebo controlled, and double blind intervention crossover study.

Patients with the genetic blistering skin condition epidermolysis bullosa (EB) report severe pain as a consequence of skin and mucous membrane lesions including blisters, wounds, and scars. Adequate symptom alleviation is not often achieved using conventional pharmacologic interventions. Finding novel approaches to pain care in EB is imperative to improve the quality of life of patients living with EB. There are several anecdotal reports on the use of cannabinoid-based medicines (CBMs) by EB patients to reduce the burden of symptoms. However, controlled clinical investigations assessing these reported effects are lacking. As the pain quality "unpleasantness" delineates EB pain, we hypothesize the modulation of affective pain processing in the brain by way of intervention with CBMs comprising the cannabinoids Δ-9-tetrahydrocannabinol and cannabidiol-objectified by functional magnetic resonance imaging (fMRI). The C4EB study is an investigator-initiated, single-centre, randomized, double-blind, placebo-controlled and crossover trial. Adult patients with the diagnosis epidermolysis bullosa, reporting chronic pain will be eligible to participate. Following baseline measurements, participants will be randomized to receive the sublingually administered interventions placebo and Transvamix® in forward or reversed orders, each for two weeks and separated by a washout. The primary outcome is the difference in numeric rating scale pain scores between grouped interventions, using affective descriptors within the Short-form McGill Pain Questionnaire-2. Secondary outcomes include pain self-efficacy, concomitant analgesic medication-use and adverse events. Additionally, fMRI will be employed to assess brain connectivity related to neuroanatomic pain circuits at baseline, placebo and Transvamix® interventions. The study was approved by the ethical committee at the University Medical Center of Groningen in the Netherlands. Results will be submitted for publication in a peer-reviewed journal. Trial registration number: Netherlands Trial Register: NL9347 (Acronym: C4EB).

Effectiveness and costs of a new framework for selecting absorbent urinary incontinence products compared with current practice: a cohort study.

OBJECTIVES: To improve continence care in the Netherlands, a new framework has been developed in which a shift has been made from incontinence severity as the sole criterion for selecting incontinence products to a focus on patient need for daily life activities. The impact of the framework on daily care has not been assessed. We aimed to compare treatment effectiveness and costs between participants who did and did not undergo re-evaluation according to the new framework. DESIGN: Cohort study SETTING: Twelve pharmacies in the Netherlands PARTICIPANTS: Existing users of absorbent incontinence materials for urinary incontinence. INTERVENTIONS: Participants were offered the option to have their incontinence products re-evaluated within the new framework at their pharmacy. PRIMARY AND SECONDARY OUTCOME MEASURES: Effectiveness and cost outcomes were assessed at 3 and 6 months through questionnaires. These questionnaires included the International Consultation on Incontinence Questionnaire (ICIQ) Lower Urinary Tract Symptoms Quality of Life Module, ICIQ Urinary Incontinence Short Form, ICIQ Absorbent Pads, questions about satisfaction and the iPCQ and iMCQ. RESULTS: 303 users consented and 279 completed the baseline questionnaire. Of these participants, 72 agreed to a re-evaluation of their incontinence materials. There was a small improvement at 3 months in the re-evaluation group compared with the other group on most outcomes. However, these improvements were not clinically relevant. Moreover, these differences did not change much from 3 to 6 months. Small differences were also observed in the changes in costs, but with very wide CIs on both sides of zero (€99.38; 95% CI -633.48 to 832.23). CONCLUSIONS: The current study showed no clinically relevant effect of a newly implemented framework for selecting incontinence materials in pharmacies when compared with an existing method. Given that the study also showed no differences in effectiveness and costs, introducing the new framework in pharmacies may not lead to better incontinence care.

Extending the use of the Endoscopic Endonasal Sinus and Skull Base Surgery Questionnaire in a cross-sectional study: Patients with chronic rhinosinusitis versus healthy controls.

OBJECTIVES: There are several instruments to assess health-related quality of life (HRQoL) in chronic rhinosinusitis (CRS). Unfortunately, none of them evaluates all three health domains (physical, social and psychological) important to assess the overall well-being of the patient. The Endoscopic Endonasal Sinus and Skull Base Surgery Questionnaire (EES-Q) does assess all these elements. Initially, the EES-Q is validated to evaluate the impact of endoscopic endonasal surgery (EES) on HRQoL. The aim of this study is to assess whether EES-Q outcomes differ in patients with CRS compared with healthy individuals. Therefore, extending the use of the EES-Q for all CRS patients. DESIGN: Cross-sectional study. SETTING: Tertiary referral hospital. PARTICIPANTS: One hundred patients with uncontrolled CRS (50% with nasal polyps) scheduled to receive EES. The questionnaire was completed preoperatively. Healthy control subjects (n = 100) without any history of sinusitis or a known current medical treatment at a hospital were included. MAIN OUTCOME MEASURES: Mann-Whitney U test was performed to identify differences in EES-Q scores (domain scores and EES-Q score). RESULTS: The median EES-Q score in CRS patients (33.8) was significantly higher (p < 0.001) than in the control group (10.4). As well as the physical (52.5 vs. 16.4, p < 0.001), psychological (13.8 vs. 5.0, p < 0.001) and social (37.5 vs. 2.5, p < 0.001) domain scores. CONCLUSIONS: With this study, we are extending the use of the EES-Q. It indicates that the EES-Q can be a valuable clinical tool to assess multidimensional HRQoL in all patients with CRS.

Cost-effectiveness of an app-based treatment for urinary incontinence in comparison with care-as-usual in Dutch general practice: a pragmatic randomised controlled trial over 12 months.

OBJECTIVE: To assess the cost-effectiveness of app-based treatment for female stress, urgency or mixed urinary incontinence (UI) compared with care-as-usual in Dutch primary care. DESIGN: A pragmatic, randomised controlled, superiority trial. SETTING: Primary care in the Netherlands from 2015 to 2018, follow-up at 12 months. POPULATION: Women with ≥2 UI-episodes per week, access to mobile apps, wanting treatment. METHODS: The standalone app included conservative management for UI with motivation aids (e.g. reminders). Care-as-usual delivered according to the Dutch GP guideline for UI. MAIN OUTCOME MEASURES: Costs and cost-effectiveness and -utility were assessed from a societal perspective, based on incontinence impact adjusted life years (IIALYs), quality adjusted life years (QALYs) and medical, non-medical and productivity costs. Information on costs was obtained with the iMCQ and iPCQ questionnaires (medical consumption and productivity cost questionnaires). RESULTS: In all, 262 women were andomised equally to app or care-as-usual; 89 (68%) and 83 (63%) attended follow-up, respectively. Costs were lower for app-based treatment with € -161 (95% confidence interval [CI -180 to -151) per year. Cost-effectiveness showed small mean differences in effect for IIALY (0.04) and QALY (-0.03) and thus larger incremental cost-effectiveness ratios (ICER: -€3696) and incremental cost-utility ratios (ICUR: €6379). CONCLUSION: App-based treatment is a cost-effective alternative to care-as-usual for women with UI in Dutch primary care. TWEETABLE ABSTRACT: App-treatment for female urinary incontinence cost-effective compared to care-as-usual in general practice after 12 months.