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1. An Autonomy-Supportive Online Decision Aid to Assist Smokers in Choosing Evidence-Based Cessation Assistance: Development Process and Protocol of a Randomized Controlled Trial

Author

Gültzow, Thomas, Smit, Eline Suzanne, Hudales, Raesita, Knapen, Vera, Rademakers, Jany, Dirksen, Carmen D, and Hoving, Ciska

Subjects
Medicine, Computer applications to medicine. Medical informatics, R858-859.7
Abstract

BackgroundDecision aids (DAs) may be used to facilitate an autonomous, informed decision to cease smoking and promote the uptake of evidence-based cessation assistance (ie, behavioral support, nicotine replacement therapy, or prescription medication). However, knowledge is lacking regarding their effective elements and (cost-)effectiveness. ObjectiveWe describe the development process of an online DA (called “VISOR”) that helps smokers to choose evidence-based cessation assistance. Additionally, we provide a description of the protocol of an ongoing randomized controlled trial in which the DA containing an explicit value clarification method (VCM) and tailored advice is compared with a DA without an explicit VCM and tailored advice. MethodsThe development of “VISOR” was based on the International Patient Decision Aid Standards guidelines. Viewpoints of end users (collected through 20 interviews with smokers) and clinical and scientific experts (assessed using 2 Delphi studies with 24 scientists and 38 clinicians) were assessed regarding cessation tool decision making and preferred DA content. These findings, together with principles from the Self-Determination Theory, served as input for the development of the online DA. A first DA prototype was alpha-tested in September 2019 and beta-tested for usability in December 2019; feedback was incorporated and resulted in a final version. The final DA contains (1) an information section, (2) an optional knowledge quiz, (3) a brief smoking assessment, (4) intuitive decision, (5) intermediate advice, (6) an explicit VCM, (7) tailored advice, and (8) access information. A randomized controlled trial is currently being conducted to assess the DA’s (cost-)effectiveness compared to a DA that does not include the explicit VCM and the tailored advice; specifically, the DA’s effect on smoking abstinence, uptake of evidence-based cessation assistance, smoking abstinence mediated through uptake of evidence-based cessation assistance, and decisional conflict are investigated. Participants are randomly allocated to receive access to 1 of the 2 DAs and are asked to complete 5 questionnaires (including the baseline questionnaire) over a period of 12 months. To evaluate the effects of the DA on the outcome measures, logistic and linear regression analyses as well as mediation analyses will be carried out. An economic evaluation will be performed to assess the cost-effectiveness. ResultsData regarding the effect of the VISOR DA are currently being collected, and data collection is expected to be concluded in 2021. ConclusionsBy making use of an iterative process that integrated different stakeholders’ perspectives (including end users), we were able to systematically design an evidence-based DA. The study will contribute to the current knowledge regarding smoking cessation DA application, the added value of explicit VCMs, and the effect of behavioral and informed decision-making outcomes. Trial RegistrationNetherlands Trial Register NL8270; https://www.trialregister.nl/trial/8270 International Registered Report Identifier (IRRID)DERR1-10.2196/21772

Published
2020
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3. Is a preoperative multidisciplinary team meeting (cost)effective to improve outcome for high-risk adult patients undergoing noncardiac surgery: the PREPARATION study—a multicenter stepped-wedge cluster randomized trial

Author

Vernooij, Jacqueline E. M., Boerlage, Romijn M., Doggen, Carine J. M., Preckel, Benedikt, Dirksen, Carmen D., van Leeuwen, Barbara L., Spruit, Rutger J., Festen, Suzanne, van der Wal-Huisman, Hanneke, van Basten, Jean P., Kalkman, Cor J., and Koning, Nick J.

Published
2023
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4. Effectiveness and cost-effectiveness of MicroShunt implantation versus standard trabeculectomy for open-angle glaucoma (a SIGHT study): study protocol of a multicentre randomised controlled trial

Author

Scheres, Lotte M. J., van den Biggelaar, Frank J. H. M., Winkens, Bjorn, Kujovic-Aleksov, Stefani, Müskens, Rogier P. H. M., de Waard, Peter W. T., de Crom, Ronald M. P. C., Ernest, Paul J. G., Pijl, Benjamin J., Ramdas, Wishal D., van Rijn, Laurentius J., Tan, Annelie, Dirksen, Carmen D., and Beckers, Henny J. M.

Published
2023
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5. Active monitoring versus an abduction device for treatment of infants with centered dysplastic hips: study protocol for a randomized controlled trial (TReatment with Active Monitoring (TRAM)-Trial)

Author

Mulder, Frederike E. C. M., Witlox, M. Adhiambo, Dirksen, Carmen D., de Witte, Pieter Bas, de Vos-Jakobs, Suzanne, Ham, Arno M. ten, Witbreuk, Melinda M. E. H., Sakkers, Ralph, Drongelen, Magritha (Margret) M. H. P. Foreman-van, Robben, Simon G. F., and Mathijssen, Nina M. C.

Published
2023
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8. Safety, effectiveness, and cost-effectiveness of immediate versus delayed sequential bilateral cataract surgery in the Netherlands (BICAT-NL study): a multicentre, non-inferiority, randomised controlled trial

Author

Spekreijse, Lindsay, Simons, Rob, Winkens, Bjorn, van den Biggelaar, Frank, Dirksen, Carmen, Bartels, Marjolijn, de Crom, Ronald, Goslings, Oege, Joosse, Maurits, Kasanardjo, Jocelyn, Lansink, Peter, Ponsioen, Theodorus, Reus, Nic, Schouten, Jan, and Nuijts, Rudy

Published
2023
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31. Responsiveness of the Patient‐Reported Outcome Measure‐Haemorrhoidal Impact and Satisfaction Score in patients with haemorrhoidal disease

Author

Kuiper, Sara Z., primary, Dirksen, Carmen D., additional, Mitalas, Litza, additional, Clermonts, Stefan H. E. M., additional, Van Dam, Kayleigh A. M., additional, De Witte, Evelien, additional, Melenhorst, Jarno, additional, Van Kuijk, Sander M. J., additional, Breukink, Stephanie O., additional, and Kimman, Merel L., additional

Published
2023
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33. Assessing quality of life in psychosocial and mental health disorders in children: a comprehensive overview and appraisal of generic health related quality of life measures

Author

Mierau, Jochen O., Kann-Weedage, Daphne, Hoekstra, Pieter J., Spiegelaar, Lisan, Jansen, Danielle E. M. C., Vermeulen, Karin M., Reijneveld, Sijmen A., van den Hoofdakker, Barbara J., Buskens, Erik, van den Akker-van Marle, M. Elske, Dirksen, Carmen D., and Groenman, Annabeth P.

Published
2020
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37. Active monitoring versus an abduction device for treatment of infants with centered dysplastic hips:study protocol for a randomized controlled trial (TReatment with Active Monitoring (TRAM)-Trial)

Author

Mulder, Frederike E.C.M., Witlox, M. Adhiambo, Dirksen, Carmen D., de Witte, Pieter Bas, de Vos-Jakobs, Suzanne, Ham, Arno M.ten, Witbreuk, Melinda M.E.H., Sakkers, Ralph, Drongelen, Magritha (Margret) M.H.P.Foreman van, Robben, Simon G.F., Mulder, Frederike E.C.M., Witlox, M. Adhiambo, Dirksen, Carmen D., de Witte, Pieter Bas, de Vos-Jakobs, Suzanne, Ham, Arno M.ten, Witbreuk, Melinda M.E.H., Sakkers, Ralph, Drongelen, Magritha (Margret) M.H.P.Foreman van, and Robben, Simon G.F.

Abstract

Background: Developmental Dysplasia of the Hip (DDH) is one of the most common pediatric orthopedic disorders, affecting 1–3% of all newborns. The optimal treatment of centered DDH is currently under debate. This randomized controlled trial aims to study the (cost-)effectiveness of active monitoring versus abduction treatment for infants with centered DDH. Methods: This is a multicenter, parallel-group, open-label, non-inferiority randomized controlled trial studying the (cost-)effectiveness of active monitoring versus abduction treatment for infants with centered DDH in fourteen hospitals in the Netherlands. In total, 800 infants with centered DDH (Graf IIa-/IIb/IIc), aged 10–16 weeks, will be randomly allocated to the active monitoring or abduction treatment group. Infants will be followed up until the age of 24 months. The primary outcome is the rate of normal hips, defined as an acetabular index lower than 25 degrees on an antero-posterior radiograph, at the age of 12 months. Secondary outcomes are the rate of normal hips at the age of 24 months, complications, time to hip normalization, the relation between baseline patient characteristics and the rate of normal hips, compliance, costs, cost-effectiveness, budget impact, health-related quality of life (HRQoL) of the infant, HRQoL of the parents/caregivers, and parent/caregiver satisfaction with the treatment protocol. Discussion: The outcomes of this randomized controlled trial will contribute to improving current care-as-usual for infants with centered DDH. Trial registration: Dutch Trial Register, NL9714, registered September 6, 2021. https://clinicaltrialregister.nl/en/trial/29596.

Published
2023

38. Effectiveness and cost-effectiveness of MicroShunt implantation versus standard trabeculectomy for open-angle glaucoma (a SIGHT study):study protocol of a multicentre randomised controlled trial

Author

Scheres, Lotte M.J., van den Biggelaar, Frank J.H.M., Winkens, Bjorn, Kujovic-Aleksov, Stefani, Müskens, Rogier P.H.M., de Waard, Peter W.T., de Crom, Ronald M.P.C., Ernest, Paul J.G., Pijl, Benjamin J., Ramdas, Wishal D., van Rijn, Laurentius J., Tan, Annelie, Dirksen, Carmen D., Beckers, Henny J.M., Scheres, Lotte M.J., van den Biggelaar, Frank J.H.M., Winkens, Bjorn, Kujovic-Aleksov, Stefani, Müskens, Rogier P.H.M., de Waard, Peter W.T., de Crom, Ronald M.P.C., Ernest, Paul J.G., Pijl, Benjamin J., Ramdas, Wishal D., van Rijn, Laurentius J., Tan, Annelie, Dirksen, Carmen D., and Beckers, Henny J.M.

Abstract

Background: Trabeculectomy is the “gold standard” initial surgical procedure for open-angle glaucoma worldwide. During the last decade, the introduction of less invasive procedures, including new bleb-forming surgery such as the MicroShunt, has altered the approach of glaucoma management. At present, there is insufficient evidence comparing the effectiveness between these procedures nor versus trabeculectomy. Furthermore, there is no data available on patient impact and cost-effectiveness. This study aims to address this gap in evidence and establish whether MicroShunt implantation is non-inferior compared to trabeculectomy with regard to effectiveness and whether it is cost-effective. Methods: A multicentre, non-inferiority, randomised controlled trial (RCT) studying open-angle glaucoma with an indication for surgery will be conducted. Patients with previous ocular surgery except for phacoemulsification are excluded, as are patients with ocular comorbidity compromising the visual field or requiring a combined procedure. After informed consent is obtained, patients will be randomly allocated to the intervention, a PRESERFLO™ MicroShunt implantation, or the control group, trabeculectomy, using block randomisation (blocks of 2, 4 or 6 patients). In total, 124 patients will be randomised in a 1:1 ratio, stratified by centre. The primary endpoint will be intraocular pressure (IOP) one year after surgery. Secondary outcomes include IOP-lowering medication use, treatment failure, visual acuity, visual field progression, additional interventions, adverse events, patient-reported outcome measures (PROMs), and cost-effectiveness. Study outcomes will be measured up to 12 months postoperatively. Discussion: This study protocol describes the design of a multicentre non-inferiority randomised controlled trial. To this date, cost-effectiveness studies evaluating the MicroShunt have not been undertaken. This multicentre RCT will provide more insight into whether MicroShunt impl

Published
2023

39. Routine Postsurgical Anesthesia Visit to Improve 30-Day Morbidity and Mortality: A Multicenter, Stepped-Wedge Cluster Randomized Interventional Study (the TRACE Study)

Author

Buhre, Wolfgang F F A, Boer, Christa, Boer, Dianne de Korte-de, Stolze, Annick, Posthuma, Linda M, Smit-Fun, Valérie M, van Kuijk, Sander, Noordzij, Peter G, Rinia, Myra, Hering, Jens-Peter, Veld, Bas 't, Scheffer, Gert-Jan, Dirksen, Carmen, Boermeester, Marja, Bonjer, Jaap, Dejong, Cees, Hollmann, Markus W, Breel, J S, van den Brink, I, van Dijk, F, Geurts, J, Glas, W, van Gorp, R, Jwair, A, Koca, F, Lange, I, Preckel, B, van Roy, J P, Theunissen, M., Wensing, A G C L, Werger, A, TRACE Study Investigators, Buhre, Wolfgang F F A, Boer, Christa, Boer, Dianne de Korte-de, Stolze, Annick, Posthuma, Linda M, Smit-Fun, Valérie M, van Kuijk, Sander, Noordzij, Peter G, Rinia, Myra, Hering, Jens-Peter, Veld, Bas 't, Scheffer, Gert-Jan, Dirksen, Carmen, Boermeester, Marja, Bonjer, Jaap, Dejong, Cees, Hollmann, Markus W, Breel, J S, van den Brink, I, van Dijk, F, Geurts, J, Glas, W, van Gorp, R, Jwair, A, Koca, F, Lange, I, Preckel, B, van Roy, J P, Theunissen, M., Wensing, A G C L, Werger, A, and TRACE Study Investigators

Abstract

Objective: To study the impact of a standardized postoperative anesthesia visit on 30-day mortality in medium to high-risk elective surgical patients. Background: Postoperative complications are the leading cause of perioperative morbidity and mortality. Although modified early warning scores (MEWS) were instituted to monitor vital functions and improve postoperative outcome, we hypothesized that complementary anesthesia expertise is needed to adequately identify early deterioration. Methods: In a prospective, multicenter, stepped-wedge cluster randomized interventional study in 9 academic and nonacademic hospitals in the Netherlands, we studied the impact of adding standardized postoperative anesthesia visits on day 1 and 3 to routine use of MEWS in 5473 patients undergoing elective noncardiac surgery. Primary outcome was 30-day mortality. Secondary outcomes included: incidence of postoperative complications, length of hospital stay, and intensive care unit admission. Results: Patients were enrolled between October 2016 and August 2018. Informed consent was obtained from 5473 patients of which 5190 were eligible for statistical analyses, 2490 in the control and 2700 in the intervention group. Thirty-day mortality was 0.56% (n = 14) in the control and 0.44% (n = 12) in the intervention group (odds ratio 0.74, 95% Confidence interval 0.34-1.62). Incidence of postoperative complications did not differ between groups except for renal complications which was higher in the control group (1.7% (n = 41) vs 1.0% (n = 27), P = 0.014). Median length of hospital stay did not differ significantly between groups. During the postanesthesia visits, for 16% (n = 437) and 11% (n = 293) of patients recommendations were given on day 1 and 3, respectively, of which 67% (n = 293) and 69% (n = 202) were followed up. Conclusions: The combination of MEWS and a postoperative anesthesia visit did not reduce 30-day mortality. Whether a postoperative anesthesia visit with strong adherence t

Published
2023

40. Is a preoperative multidisciplinary team meeting (cost)effective to improve outcome for high-risk adult patients undergoing noncardiac surgery: the PREPARATION study—a multicenter stepped-wedge cluster randomized trial

Author

Medische staf Anesthesiologie, Vernooij, Jacqueline E.M., Boerlage, Romijn M., Doggen, Carine J.M., Preckel, Benedikt, Dirksen, Carmen D., van Leeuwen, Barbara L., Spruit, Rutger J., Festen, Suzanne, van der Wal-Huisman, Hanneke, van Basten, Jean P., Kalkman, Cor J., Koning, Nick J., Medische staf Anesthesiologie, Vernooij, Jacqueline E.M., Boerlage, Romijn M., Doggen, Carine J.M., Preckel, Benedikt, Dirksen, Carmen D., van Leeuwen, Barbara L., Spruit, Rutger J., Festen, Suzanne, van der Wal-Huisman, Hanneke, van Basten, Jean P., Kalkman, Cor J., and Koning, Nick J.

Published
2023

44. English translation and cross‐cultural validation of the patient‐reported outcome measurement‐haemorrhoidal impact and satisfaction score (PROM‐HISS).

Author

Kuiper, Sara Zwier, Kimman, Merel L., Cooper, Rowena, O'Neill, Hannah, Watson, Angus J. M., Melenhorst, Jarno, Breukink, Stephanie O., and Dirksen, Carmen D.

Subjects
TRANSLATING & interpreting, ENGLISH language, SATISFACTION, PHYSICIANS, COMPUTER adaptive testing, PATIENT satisfaction
Abstract

Aim: The aim of this study was to translate the Dutch patient‐reported outcome measure‐haemorrhoidal impact and satisfaction score (PROM‐HISS) to English and perform a cross‐cultural validation. Method: The ISPOR good practice guidelines for the cross‐cultural validation of PROMs were followed and included two steps: (1) Two forward and two backward translations. The forward translation concerned the translation from the source language (Dutch) to the target language (English), performed by two independent English speakers, one medical doctor and one nonmedical. Subsequently, a discussion about discrepancies in the reconciled version was performed by a stakeholder group. (2) Cognitive interviews were held with patients with haemorrhoidal disease (HD), probing the comprehensibility and comprehensiveness of the PROM‐HISS. Results: Discrepancies in the reconciled forward translation concerned the terminology of HD symptoms. Furthermore, special attention was paid to the response options, ranging from "not at all", indicating minor symptoms, to "a lot", implying many symptoms. Consensus among the stakeholder group about the final version of the translated PROM‐HISS was reached. Interviews were conducted with 10 native English‐speaking HD patients (30% female), with a mean age of 44 years (24–83) and primarily diagnosed with grade II HD (80%). The mean time to complete the PROM‐HISS was 1 min 43 s. Patients showed a good understanding of the questions and response options, found all items relevant and did not miss important symptoms or topics. Conclusion: The translated English language PROM‐HISS is a valid tool to assess symptoms of HD, its impact on daily activities and patient satisfaction with HD treatment. [ABSTRACT FROM AUTHOR]

Published
2023
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48. Societal costs of subclinical depressive symptoms in Dutch adolescents

Author

Bodden, Denise H. M., Heuvel, Marieke W. H., Engels, Rutger C. M. E., Dirksen, Carmen D., Leerstoel Dekovic, Development and Treatment of Psychosocial Problems, RS: CAPHRI - R2 - Creating Value-Based Health Care, Health Services Research, MUMC+: KIO Kemta (9), Leerstoel Dekovic, Development and Treatment of Psychosocial Problems, Clinical Psychology, and Educational and Developmental Psychology

Subjects
medicine.medical_specialty, economic evaluation, Adolescent, DISORDERS, Total cost, Cost-Benefit Analysis, Prevalence, CHILDREN, Pediatrics, SOMATIC SYMPTOMS, EXPENDITURES, AGE, SDG 3 - Good Health and Well-being, Surveys and Questionnaires, Societal perspective, Cost of illness, medicine, Developmental and Educational Psychology, Humans, Pediatrics, Perinatology, and Child Health, Psychiatry, Depressive symptoms, Depression (differential diagnoses), health care economics and organizations, Subclinical infection, Depressive Disorder, Major, Reproducibility of Results, CARE, Perinatology, Adolescence, and Child Health, Psychiatry and Mental health, SCHOOL, Pediatrics, Perinatology and Child Health, Economic evaluation, depression, BURDEN, Psychology
Abstract

Background: Subclinical depressive symptoms are highly prevalent among adolescents and are associated with negative consequences, which may pose an economic burden for society. We conducted a prevalence-based cost-of-illness study using a societal perspective to investigate the cost-of-illness of subclinical depressive symptoms among adolescents. Methods: Using a bottom-up approach, cost questionnaires were assessed to measure costs from 237 Dutch families with an adolescent aged 11–18 with subclinical depressive symptoms (of which 34 met the criteria of a depressive disorder). The study is registered in the Dutch Trial Register (Trial NL5584/NTR6176; www.trialregister.nl/trial/5584). Results: Our calculations show that adolescents with subclinical depressive symptoms cost the Dutch society more than €42 million annually, expressed in costs related to depressive symptoms. Secondary analyses were performed to test the reliability and stability of the costs. When costs related to psychological problems were considered, the annual costs amounted to €67 million. The total societal costs related to physical problems amounted to approximately €126 million. All costs combined (depressive, psychological, behavioural and physical problems and other reasons) amounted to a €243 million. Total costs were highest for physical-related problems of the adolescent (52% of the total costs), followed by psychological (28%), depressive (17%) and behavioural problems (1%). Using an international prevalence rate, societal costs related to depressive symptoms resulted in €54 million a year. Conclusions: Cost-effective prevention programmes seem warranted given the high societal costs and risk of future costs as subclinical depressive symptoms could be a precursor of clinical depression later in life.

Published
2021

49. Ophthalmologists' attitudes toward immediate sequential bilateral cataract surgery: Dutch national survey

Author

Spekreijse, Lindsay S, Veldhuizen, Claudette A, Henry, Ype P, van den Biggelaar, Frank J H M, Dirksen, Carmen D, Nuijts, Rudy M M A, Ophthalmology, MUMC+: MA UECM AIOS (9), MUMC+: MA UECM Oogartsen MUMC (9), Oogheelkunde, RS: MHeNs - R3 - Neuroscience, MUMC+: KIO Kemta (9), Health Services Research, RS: CAPHRI - R2 - Creating Value-Based Health Care, and MUMC+: *AB Refractie Chirurgie Oogheelkunde (9)

Subjects
Endophthalmitis, Ophthalmology, Cross-Sectional Studies, Ophthalmologists, Humans, Surgery, Cataract Extraction, Cataract, Sensory Systems
Abstract

PURPOSE: To evaluate current practice patterns of immediate sequential bilateral cataract surgery (ISBCS) in the Netherlands and assess ophthalmologists' attitudes towards performing ISBCS in future cataract care.SETTING: Dutch ophthalmic society members.DESIGN: Cross-sectional study (national survey).METHODS: An electronic survey on ISBCS was sent as part of an annual survey on cataract practice patterns to members of the Dutch ophthalmic society. Questions regarding current ISBCS practice patterns, willingness to perform ISBCS routinely in future care, reasons for performing ISBCS and reasons for not performing ISBCS were included. Data were analysed using descriptive statistics.RESULTS: In total, 237/520 survey recipients (45.6%) responded to the overall survey. Data on the ISBCS questions was available from 227 respondents. Sixty-two ophthalmologists (27.3%) currently performed ISBCS, predominantly in low patient-volumes (90.3% in one to five patients per month). However, 108/227 ophthalmologists (47.6%) considered performing ISBCS routinely in future practice. Procedures for which ISBCS was mainly considered included age-related cataract surgery using topical and general anaesthesia. Availability of separate products and instruments for both eyes and patient advantages were considered of high importance when performing ISBCS. Main reasons for not performing ISBCS included the risk of endophthalmitis and potential medico-legal aspects.CONCLUSIONS: Although ISBCS is currently no routine procedure in the Netherlands, it is considered by almost 50% of surgeons. In order to improve implementation on a national level, potential barriers identified in this survey (fear of bilateral endophthalmitis, potential medico-legal issues, a lack of availability of separate products for both eyes) should be addressed.

Published
2022

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