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1. How mature are survival data at the time of an interim analysis in a clinical trial with a survival outcome?

Author

Jonker, Marianne A and Teerenstra, Steven

Subjects
Statistics - Methodology, Statistics - Applications
Abstract

In a clinical trial with a survival outcome, an interim analysis is often performed to allow for early stopping for efficacy. If the interim analysis is early in the trial, one might conclude that a new treatment is more effective (compared to e.g.\ a placebo) and stop the trial, whereas the survival curves in the trial arms are not mature for the research question under investigation, for example because the curves are still close to 1 at that time. This means that the decision is based on a small percentage of the events in the long run only; possibly the events of the more frail patients in the trial who may not be representative for the whole group of patients. It may not be sensible to conclude effectiveness based on so little information. Criteria to determine the moment the interim analysis will be performed, should be chosen with care, and include the maturity of the data at the time of the interim analysis. Here, the expected survival rates at the interim analysis play a role. In this paper we will derive the asymptotic distribution of the Kaplan-Meier curves at the (random) moment the interim analysis will be performed for a one and two arm clinical trial. Based on this distribution, an interval in which the Kaplan Meier curves will fall into (with probability 95\%) is derived and could be used to plan the moment of the interim analysis in the design stage of the trial, so before the trial starts., Comment: 21 pages, 2 figures, 3 tables

Published
2023

3. Internet and Social Media For Health-Related Information and Communication in Health Care: Preferences of the Dutch General Population

Author

Van de Belt, Tom H, Engelen, Lucien JLPG, Berben, Sivera AA, Teerenstra, Steven, Samsom, Melvin, and Schoonhoven, Lisette

Subjects
Computer applications to medicine. Medical informatics, R858-859.7, Public aspects of medicine, RA1-1270
Abstract

BackgroundHealth care is increasingly featured by the use of Web 2.0 communication and collaborative technologies that are reshaping the way patients and professionals interact. These technologies or tools can be used for a variety of purposes: to instantly debate issues, discover news, analyze research, network with peers, crowd-source information, seek support, and provide advice. Not all tools are implemented successfully; in many cases, the nonusage attrition rates are high. Little is known about the preferences of the Dutch general population regarding the use of the Internet and social media in health care. ObjectiveTo determine the preferences of the general population in the Netherlands regarding the use of the Internet and social media in health care. MethodsA cross-sectional survey was disseminated via a popular Dutch online social network. Respondents were asked where they searched for health-related information, how they qualified the value of different sources, and their preferences regarding online communication with health care providers. Results were weighed for the Dutch population based on gender, age, and level of education using official statistics. Numbers and percentages or means and standard deviations were presented for different subgroups. One-way ANOVA was used to test for statistical differences. ResultsThe survey was completed by 635 respondents. The Internet was found to be the number one source for health-related information (82.7%), closely followed by information provided by health care professionals (71.1%). Approximately one-third (32.3%) of the Dutch population search for ratings of health care providers. The most popular information topics were side effects of medication (62.5%) and symptoms (59.7%). Approximately one-quarter of the Dutch population prefer to communicate with a health care provider via social media (25.4%), and 21.2% would like to communicate via a webcam. ConclusionsThe Internet is the main source of health-related information for the Dutch population. One in 4 persons wants to communicate with their physician via social media channels and it is expected that this number will further increase. Health care providers should explore new ways of communicating online and should facilitate ways for patients to connect with them. Future research should aim at comparing different patient groups and diseases, describing best practices, and determining cost-effectiveness.

Published
2013
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4. Towards patient-led follow-up after curative surgical resection of stage I, II and III colorectal cancer (DISTANCE-trial): a study protocol for a stepped-wedge cluster-randomised trial

Author

Swartjes, Hidde, Qaderi, Seyed M., Teerenstra, Steven, Custers, Jose A. E., Elferink, Marloes A. G., van Wely, Bob J., Burger, Jacobus W. A., van Grevenstein, Wilhelmina M. U., van Duijvendijk, Peter, Verdaasdonk, Emiel G. G., de Roos, Marnix A. J., Coupé, Veerle M. H., Vink, Geraldine R., Verhoef, Cornelis, and de Wilt, Johannes H. W.

Published
2023
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6. Effect of a Standardized Family Participation Program in the ICU: A Multicenter Stepped-Wedge Cluster Randomized Controlled Trial*

Author

Dijkstra, Boukje M., Rood, Paul J.T., Teerenstra, Steven, Rutten, Anne M.F., Leerentveld, Crista, Burgers-Bonthuis, Dominique C., Festen-Spanjer, Barbara, Klarenbeek, Toine, Van Den Boogaard, Mark, Ewalds, Esther, Schoonhoven, Lisette, Van Der Hoeven, Johannes G., Vloet, Lilian C.M., Rovers, Anouk, de Bruijn, Esther, Wittenberg, Wendy, Geldof, Ellen, Bekers, Erica, Schoenmakers, Ingeborg, van Dartel-Dorgelo, Kim, Kiekebos-Terdu, Hadewey, Krist-Meppelink, Jany, Pap-Brugmans, Alice, Spanjer-Eilerts, Johanneke, Veen-Schra, Felicia, Wentink, Arne, Aghmiri, Mariem, Castelijns-Bakker, Danielle, Charmant, Sandy, Ederveen-Van Tiggelen, Henriëtte, Osinski, Aart, Westerlaan, Demi, Brouwer, Tessa, Eijkenboom-Wattel, Nicky, Jaspers, Marissa, Kremers-van Hees, Lisette, van Mackelenberg, Ed, Meijer-Wijting, Suzan, Vrieselaar, Lianne, Vogelesang, Helene, Teitink, Yvonne, Bouw, Marianne, and Swaen-Dekkers, Yvonne

Published
2024
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9. Implementing a Personalized Physical Therapy Approach (Coach2Move) Is Effective in Increasing Physical Activity and Improving Functional Mobility in Older Adults: A Cluster-Randomized, Stepped Wedge Trial

Author

Heij, Ward, Sweerts, Lieke, Staal, J. Bart, Teerenstra, Steven, Adang, Eddy, van der Wees, Philip J., Nijhuis-van der Sanden, Maria W.G., and Hoogeboom, Thomas J.

Subjects
Aged -- Care and treatment, Therapeutics, Physiological -- Methods -- Testing, Physical therapy -- Methods -- Testing, Physical therapy for the aged -- Methods -- Testing
Abstract

Objective. The purpose of this study was to assess whether the superior cost-effectiveness of a personalized physical therapy approach (Coach2Move)--which was demonstrated in a previous trial compared with usual care physical therapy (UCP)--can be replicated in daily clinical practice. Methods. A multicenter, cluster-randomized, stepped wedge trial with 4 clusters consisting of 4 physical therapist practices in the Netherlands was used to compare a personalized physical therapy approach to elicit physical activity (Coach2Move) versus care as usual. Multilevel analyses for effectiveness were conducted for the amount of physical activity (Longitudinal Aging Study Amsterdam Physical Activity Questionnaire) and functional mobility (Timed "Up & Go" Test) at 3, 6 (primary outcome), and 12 months' follow-up. Secondary outcomes were level of frailty (Evaluative Frailty Index for Physical Activity), perceived effect (Global Perceived Effect and Patient-Specific Complaints Questionnaires), quality of life (Euro Quality of Life-5 Dimensions-5 Levels [EQ-5D-5L]), and health care expenditures. Results. The 292 community-dwelling older adults with mobility problems visiting physical therapists were included in either the Coach2Move (n = 112; mean [SD] age = 82 [5] years; 60% female) or UCP (n = 180; mean [SD] age = 81 (6) years; 62% female) section of the trial. At baseline, Coach2Move participants were less physically active compared with UCP participants (mean difference = -198; 95% CI = -90 to -306 active minutes). At 6 months, between-group mean differences [95% CI] favored Coach2Move participants on physical activity levels (297 [83 to 512] active minutes), functional mobility (-14.2 [-21 to -8]) seconds), and frailty levels (-5[-8 to -1] points). At 12 months, the physical activity levels of Coach2Move participants further increased, and frailty levels and secondary outcomes remained stable, whereas outcomes of UCP participants decreased. After the Coach2Move implementation strategy, physical therapists utilized significantly fewer treatment sessions compared with before the implementation (15 vs 22). Anticipated cost savings were not observed. Conclusion. This study replicated the results of an earlier trial and shows that Coach2Move leads to better mid- and long-term outcomes (physical activity, functional mobility, level of frailty) in fewer therapy sessions compared with UCF' Based on these and earlier findings, the implementation of Coach2Move in physical therapist practice is recommended. Impact. This article describes the implementation of the Coach2Move approach, a treatment strategy that has proven to be cost-effective in a previously conducted randomized controlled trial. Implementation of Coach2Move in a real-life setting allowed an evaluation of the effects in a clinically relevant population. Coach2Move has been shown to increase physical activity, improve functional mobility, and reduce frailty more effectively compared with UCP therapy and therefore has application for physical therapists working with older adults in daily clinical practice. Lay summary. Coach2Move is a new physical therapy approach for older adults. Implementation of Coach2Move in daily clinical practice can help people better outcomes over a longer period of time against similar costs compared with regular physical therapy. Keywords: Aged, Decision Making: Clinical, Evidence-Based Practice, Patient-Centered Care, Physical Therapists, Primary Health Care, Introduction Physical activity is beneficial to improve quality of life and to counter adverse effects of frailty and comorbidities in older adults. (1) However, adoption and maintenance of an active [...]

Published
2022
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18. Multimodal prehabilitation (Fit4Surgery) in high-impact surgery to enhance surgical outcomes: Study protocol of F4S PREHAB, a single center stepped wedge trial.

Author

Strijker, Dieuwke, Drager, Luuk, van Asseldonk, Monique, Atsma, Femke, van den Berg, Manon, van Daal, Elke, van Heusden-Scholtalbers, Linda, Meijerink, Jeroen, Servaes, Petra, Teerenstra, Steven, Verlaan, Sjors, van den Heuvel, Baukje, and van Laarhoven, Kees

Subjects
PREHABILITATION, PREOPERATIVE risk factors, PREOPERATIVE care, SURGICAL complications, ABDOMINAL surgery, SPECIALTY hospitals, GYMNASIUMS, MULTIMODAL user interfaces
Abstract

Background: High-impact surgery imposes a significant physiological and functional burden and is associated with substantial postoperative morbidity. Multimodal prehabilitation has demonstrated a reduction in postoperative complications and enhanced functional recovery, mainly in abdominal cancer surgery. Common preoperative risk factors shared among patients undergoing high-impact surgery, extending beyond abdominal cancer surgery procedures, suggest the relevance of multimodal prehabilitation to a broader patient population. This stepped wedge trial primarily aims to examine the hospital-wide effect of multimodal prehabilitation, compared to standard preoperative care, on the occurrence and severity of postoperative complications. Secondary and tertiary endpoints include length of hospital stay, physical fitness, nutritional status, mental health, intoxications, and cost-effectiveness of the intervention. Methods: The Fit4Surgery (F4S) PREHAB trial is a monocenter stepped wedge trial in an academic hospital. Adult patients, divided into 20 health clusters based on specific diagnoses, will be assessed for eligibility and receive usual preoperative care or multimodal prehabilitation. Patient enrollment commenced in March 2021 and continues up to and including April 2024. The intervention consists of a high-intensity exercise program, a nutritional intervention, psychological support, and smoking and alcohol cessation. The primary outcome will be measured by the Clavien-Dindo classification (grade II or higher) and the Comprehensive Complication Index (CCI). Discussion: Multimodal prehabilitation potentially reduces postoperative complications and enhances functional recovery. This is the first study to determine the hospital-wide effect and cost-effectiveness of multimodal prehabilitation in patients across various surgical specialties. [ABSTRACT FROM AUTHOR]

Published
2024
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19. Possible data-generating models of longitudinal continuous outcomes and intercurrent events to investigate estimands.

Author

Mitroiu, Marian, Teerenstra, Steven, Oude Rengerink, Katrien, Pétavy, Frank, and Roes, Kit CB

Subjects
*SURVIVAL rate, *CONTINUOUS distributions, *CLINICAL trials, *TREATMENT effectiveness, *SURVIVAL analysis (Biometry)
Abstract

AbstractIntroduction/BackgroundMethodsResultsConclusionWe aimed to explore data-generating models to jointly simulate outcomes and intercurrent events for randomised clinical trials to enable the investigation of estimands.We developed four possible data-generating models for the joint distribution of longitudinal continuous clinical outcomes and intercurrent events under the scenario where they are observable: a selection model, a pattern-mixture mixed model, a shared-parameter model and a joint model of longitudinally observed outcomes and a survival model for intercurrent events. We present a case study in a short-term depression trial with repeated measurements of continuous outcomes and two types of intercurrent events, and evaluate the potential and challenges of such data-generating models.Simulating randomised trials with outcomes and intercurrent events is a complex undertaking. We found that the four possible data-generating models can simulate different types of intercurrent events and associated longitudinal outcomes. They can be used to emulate envisaged patterns of intercurrent events and outcomes informed by prior available trial data or expectations. Model and parameter choice for a given application requires further development.The four possible data-generating models could be used to investigate different estimands and their properties in-depth in the design stage. Thereby they are useful tools for the selection of estimands a priori. [ABSTRACT FROM AUTHOR]

Published
2024
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26. Effects of a Multidisciplinary Intervention on the Presence of Neuropsychiatric Symptoms and Psychotropic Drug Use in Nursing Home Residents WithYoung-Onset Dementia: Behavior and Evolution of Young-Onset Dementia Part 2 (BEYOND-II) Study

Author

Appelhof, Britt, Bakker, Christian, de Vugt, Marjolein E., van Duinen-van den IJssel, Jeannette C.L., Zwijsen, Sandra A., Smalbrugge, Martin, Teerenstra, Steven, Verhey, Frans R.J., Zuidema, Sytse U., and Koopmans, Raymond T.C.M.

Published
2019
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27. Quality of stepped-wedge trial reporting can be reliably assessed using an updated CONSORT: crowd-sourcing systematic review

Author

Dutton, Susan J., Madurasinghe, Vichithranie, Morgan, Katy, Stuart, Beth, Fielding, Katherine, Cornelius, Victoria, Turner, Elizabeth L., Hooper, Richard, Giraudeau, Bruno, Seed, Paul T., Nickless, Alecia, Grayling, Michael, Prague, Melanie, Kerry, Sally, Bell, Lauren, Watson, Eila, Gafoor, Rafael, Marlin, Nadine, Yorganci, Emel, Smith, Lesley, Mbekwe, Murielle, Teerenstra, Steven, Chan, Claire, Moerbeek, Mirjam, Jacobsen, Pamela, Bond, Simon, Jones, Ben, Preisser, John, Kanaan, Mona, Hewitt, Catherine, Easter, Christina, Pellatt-Higgins, Tracy, Pankhurst, Laura, Agbla, Schadrac C., Eldridge, Sandra, Lerner, Robin G., Leyrat, Clémence, Pilling, Mark, Forman, Julia R., Bhattacharya, Indrani, Magill, Nicholas, Candlish, Jane, McDowell, Cliona, Martin, James, Kristunas, Caroline, Allen, Elizabeth, Seward, Nadine, Nicholls, Elaine, Franklin, Bryony Dean, Hemming, Karla, Carroll, Kelly, Thompson, Jennifer, Forbes, Andrew, and Taljaard, Monica

Published
2019
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29. The Impact of Non-Pharmacological Interventions on Delirium in Neurological Intensive Care Unit Patients: A Single-Center Interrupted Time Series Trial

Author

Rood, Paul J. T., primary, Ramnarain, Dharmanand, additional, Oldenbeuving, Annemarie W., additional, den Oudsten, Brenda L., additional, Pouwels, Sjaak, additional, van Loon, Lex M., additional, Teerenstra, Steven, additional, Pickkers, Peter, additional, de Vries, Jolanda, additional, and van den Boogaard, Mark, additional

Published
2023
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32. Implementation of a Cost-Effective Physical Therapy Approach (Coach2Move) to Improve Physical Activity in Community-Dwelling Older Adults With Mobility Problems: Protocol for a Cluster-Randomized, Stepped Wedge Trial

Author

Heij, Ward, Teerenstra, Steven, Sweerts, Lieke, Staal, J. Bart, W.G. Nijhuis-Sanden, Maria van der, and Hoogeboom, Thomas J.

Subjects
Clinical trials -- Economic aspects -- Comparative analysis, Health care costs -- Comparative analysis -- Economic aspects, Physical fitness -- Comparative analysis -- Economic aspects, Elderly fitness -- Comparative analysis -- Economic aspects, Physical therapy -- Comparative analysis -- Economic aspects, Elderly -- Economic aspects -- Comparative analysis, Exercise -- Economic aspects -- Comparative analysis, Physical therapists, Setting (Literature), Medical economics, Regression analysis, Health
Abstract

Background. Coach2Move is a personalized treatment strategy by physical therapists to elicit physical activity in community-dwelling older adults with mobility problems. Objective. The primary objective of this study is to assess the effectiveness and cost-effectiveness of the implementation of Coach2Move compared with regular care physical therapy in daily clinical practice. Design, Setting, Participants, and Intervention. A multicenter cluster-randomized stepped wedge trial is being implemented in 16 physical therapist practices (4 clusters of 4 practices in 4 steps) in the Netherlands. The study aims to include 400 older adults ([greater than or equal to]70 years) living independently with mobility problems and/or physically inactive lifestyles. The intervention group receives physical therapy conforming to the Coach2Move strategy; the usual care group receives typical physical therapist care. Measurements. Measurements are taken at baseline and 3, 6, and 12 months after the start of treatment. The primary outcomes for effectiveness are the amount of physical activity (LASA Physical Activity Questionnaire) and functional mobility (Timed Up and Go test). Trial success can be declared if at least 1 parameter improves while another does not deteriorate. Secondary outcomes are level of frailty (Evaluative Frailty Index for Physical Activity), perceived effect (Global Perceived Effect and Patient Specific Complaints questionnaire), quality of life (EQ-5D-5 L), and health care expenditures. Multilevel linear regression analyses are used to compare the outcomes between treatment groups according to an intention-to-treat approach. Alongside the trial, a mixed-methods process evaluation is performed to understand the outcomes, evaluate therapist fidelity to the strategy, and detect barriers and facilitators in implementation. Limitations. An important limitation of the study design is the inability to blind treating therapists to study allocation. Discussion. The trial provides insight into the effectiveness and cost-effectiveness of the Coach2Move strategy compared with usual care. The process evaluation provides insight into influencing factors related to outcomes and implementation., Physical activity has beneficial effects for older adults in the prevention and reduction of frailty and improvement of quality of life. (1) However, increasing physical activity is known to be [...]

Published
2020
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33. The 'Diagnostic Guideline for Anxiety and Challenging Behaviour' for Persons with Intellectual Disabilities: Preliminary Outcomes on Internalizing Problems, Challenging Behaviours, Quality of Life and Clients' Satisfaction

Author

Pruijssers, Addy, Meijel, Berno, Maaskant, Marian, Teerenstra, Steven, and van Achterberg, Theo

Abstract

Background: People with intellectual disabilities are vulnerable to develop psychopathology (in particular anxiety) and related challenging behaviour. Method: A comparative multiple case study with an experimental and a control condition. Results: The application of the guideline showed a trend of decreases of internalizing problems (P = 0.07) and anxiety/depressed problems (P = 0.09). We found no statistically significant decreases of externalizing problems and no increases in perceived quality of life as compared with care as usual. Clients were not more satisfied with the support they received for coping with their emotional and behaviour problems. Conclusion: The application of the "Diagnostic Guideline for Anxiety and Challenging Behaviour" did not show statistically significant changes in externalizing problems and Quality of Life. Despite the small sample size of n = 59, we did find a trend in decreasing internalizing problems and anxiety/depressed problems. Further research into either or not confirming these trends is recommended.

Published
2017
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40. Hypoglycaemia induces a sustained pro‐inflammatory response in people with type 1 diabetes and healthy controls.

Author

Verhulst, Clementine E. M., van Heck, Julia I. P., Fabricius, Therese W., Stienstra, Rinke, Teerenstra, Steven, McCrimmon, Rory J., Tack, Cees J., Pedersen‐Bjergaard, Ulrik, and de Galan, Bastiaan E.

Subjects
TYPE 1 diabetes, HYPOGLYCEMIA, INSULIN aspart, GLUCOSE clamp technique, LYMPHOCYTE count, C-reactive protein
Abstract

Aim: To determine the duration and the extension of the pro‐inflammatory response to hypoglycaemia both in people with type 1 diabetes and healthy controls. Materials and Methods: Adults with type 1 diabetes (n = 47) and matched controls (n = 16) underwent a hyperinsulinaemic‐euglycaemic hypoglycaemic (2.8 ± 0.1 mmoL/L [49.9 ± 2.3 mg/dL]) glucose clamp. During euglycaemia, hypoglycaemia, and 1, 3 and 7 days later, blood was drawn to determine immune cell phenotype, monocyte function and circulating inflammatory markers. Results: Hypoglycaemia increased lymphocyte and monocyte counts, which remained elevated for 1 week. The proportion of CD16+ monocytes increased and the proportion of CD14+ monocytes decreased. During hypoglycaemia, monocytes released more tumour necrosis factor‐α and interleukin‐1β, and less interleukin‐10, after ex vivo stimulation. Hypoglycaemia increased the levels of 19 circulating inflammatory proteins, including high sensitive C‐reactive protein, most of which remained elevated for 1 week. The epinephrine peak in response to hypoglycaemia was positively correlated with immune cell number and phenotype, but not with the proteomic response. Conclusions: Overall, despite differences in prior exposure to hypoglycaemia, the pattern of the inflammatory responses to hypoglycaemia did not differ between people with type 1 diabetes and healthy controls. In conclusion, hypoglycaemia induces a range of pro‐inflammatory responses that are sustained for at least 1 week in people with type 1 diabetes and healthy controls. [ABSTRACT FROM AUTHOR]

Published
2023
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43. Data from Cancer Patients Treated with Sunitinib or Sorafenib Have Sufficient Antibody and Cellular Immune Responses to Warrant Influenza Vaccination

Author

Mulder, Sasja F., primary, Jacobs, Joannes F.M., primary, Olde Nordkamp, Michel A.M., primary, Galama, Joep M.D., primary, Desar, Ingrid M.E., primary, Torensma, Ruurd, primary, Teerenstra, Steven, primary, Mulders, Peter F.A., primary, Vissers, Kris C.P., primary, Punt, Cornelis J.A., primary, de Vries, I. Jolanda M., primary, and van Herpen, Carla M.L., primary

Published
2023
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44. Supplementary Figures S1-S3 from Cancer Patients Treated with Sunitinib or Sorafenib Have Sufficient Antibody and Cellular Immune Responses to Warrant Influenza Vaccination

Author

Mulder, Sasja F., primary, Jacobs, Joannes F.M., primary, Olde Nordkamp, Michel A.M., primary, Galama, Joep M.D., primary, Desar, Ingrid M.E., primary, Torensma, Ruurd, primary, Teerenstra, Steven, primary, Mulders, Peter F.A., primary, Vissers, Kris C.P., primary, Punt, Cornelis J.A., primary, de Vries, I. Jolanda M., primary, and van Herpen, Carla M.L., primary

Published
2023
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45. Methodical advances in reproducibility research: A proof of concept qualitative comparative analysis of reproducing animal data in humans

Author

AISS Sustainable Animal Stewardship, Dep Population Health Sciences, LS wijsgerige Ethiek, OFR - Ethics Institute, AISS – Sustainable Animal Stewardship, Leenaars, Cathalijn H.C., Teerenstra, Steven, Meijboom, Franck L.B., Bleich, André, AISS Sustainable Animal Stewardship, Dep Population Health Sciences, LS wijsgerige Ethiek, OFR - Ethics Institute, AISS – Sustainable Animal Stewardship, Leenaars, Cathalijn H.C., Teerenstra, Steven, Meijboom, Franck L.B., and Bleich, André

Published
2023

46. Towards patient-led follow-up after curative surgical resection of stage I, II and III colorectal cancer (DISTANCE-trial):a study protocol for a stepped-wedge cluster-randomised trial

Author

Swartjes, Hidde, Qaderi, Seyed M., Teerenstra, Steven, Custers, Jose A.E., Elferink, Marloes A.G., van Wely, Bob J., Burger, Jacobus W.A., van Grevenstein, Wilhelmina M.U., van Duijvendijk, Peter, Verdaasdonk, Emiel G.G., de Roos, Marnix A.J., Coupé, Veerle M.H., Vink, Geraldine R., Verhoef, Cornelis, de Wilt, Johannes H.W., Swartjes, Hidde, Qaderi, Seyed M., Teerenstra, Steven, Custers, Jose A.E., Elferink, Marloes A.G., van Wely, Bob J., Burger, Jacobus W.A., van Grevenstein, Wilhelmina M.U., van Duijvendijk, Peter, Verdaasdonk, Emiel G.G., de Roos, Marnix A.J., Coupé, Veerle M.H., Vink, Geraldine R., Verhoef, Cornelis, and de Wilt, Johannes H.W.

Abstract

Background: Colorectal cancer (CRC) is among the most frequently diagnosed cancers. Approximately 20–30% of stage I-III CRC patients develop a recurrent tumour or metastases after curative surgical resection. Post-operative follow-up is indicated for the first five years after curative surgical resection. As intensified follow-up after curative surgical resection has shown no effect on survival, patient organisations and policy makers have advocated for a more patient-centred approach to follow-up. The objective of this study is to successfully implement patient-led, home-based follow-up (PHFU) in six hospitals in The Netherlands, with as ultimate aim to come to a recommendation for a patient-centred follow-up schedule for stage I-III CRC patients treated with surgical resection with curative intent. Methods: This study is designed as a stepped-wedge cluster-randomised trial (SW-CRT) in six participating centres. During the trial, three centres will implement PHFU after six months; the other three centres will implement PHFU after 12 months of inclusion in the control group. Eligible patients are those with pT2-4N0M0 or pT1-4N1-2M0 CRC, who are 18 years or older and have been free of disease for 12 months after curative surgical resection. The studied intervention is PHFU, starting 12 months after curative resection. The in-hospital, standard-of-care follow-up currently implemented in the participating centres functions as the comparator. The proportion of patients who had contact with the hospital regarding CRC follow-up between 12–24 months after curative surgical resection is the primary endpoint of this study. Quality of life, fear of cancer recurrence, patient satisfaction, cost-effectiveness and survival are the secondary endpoints. Discussion: The results of this study will provide evidence on whether nationwide implementation of PHFU for CRC in The Netherlands will be successful in reducing contact between patient and health care provider. Comparison of P

Published
2023

47. Towards patient-led follow-up after curative surgical resection of stage I, II and III colorectal cancer (DISTANCE-trial): a study protocol for a stepped-wedge cluster-randomised trial

Author

MS CGO, Cancer, Medisch Oncologische Disciplines, Onderzoek Medische Oncologie, Swartjes, Hidde, Qaderi, Seyed M., Teerenstra, Steven, Custers, Jose A.E., Elferink, Marloes A.G., van Wely, Bob J., Burger, Jacobus W.A., van Grevenstein, Wilhelmina M.U., van Duijvendijk, Peter, Verdaasdonk, Emiel G.G., de Roos, Marnix A.J., Coupé, Veerle M.H., Vink, Geraldine R., Verhoef, Cornelis, de Wilt, Johannes H.W., MS CGO, Cancer, Medisch Oncologische Disciplines, Onderzoek Medische Oncologie, Swartjes, Hidde, Qaderi, Seyed M., Teerenstra, Steven, Custers, Jose A.E., Elferink, Marloes A.G., van Wely, Bob J., Burger, Jacobus W.A., van Grevenstein, Wilhelmina M.U., van Duijvendijk, Peter, Verdaasdonk, Emiel G.G., de Roos, Marnix A.J., Coupé, Veerle M.H., Vink, Geraldine R., Verhoef, Cornelis, and de Wilt, Johannes H.W.

Published
2023

49. Glycaemic thresholds for counterregulatory hormone and symptom responses to hypoglycaemia in people with and without type 1 diabetes: a systematic review

Author

Verhulst, Clementine EM, Fabricius, Therese W, Teerenstra, Steven, Kristensen, Peter L, Tack, Cees J, McCrimmon, Rory J, Heller, Simon, Evans, Mark L, Amiel, Stephanie A, Pedersen-Bjergaard, Ulrik, De Galan, Bastiaan E, Hypo-RESOLVE Consortium, Verhulst, Clementine EM [0000-0002-9905-7669], Fabricius, Therese W [0000-0002-6344-5408], Teerenstra, Steven [0000-0003-4103-7451], Kristensen, Peter L [0000-0001-5431-824X], Tack, Cees J [0000-0003-0322-1653], McCrimmon, Rory J [0000-0002-3957-1981], Heller, Simon [0000-0002-2425-9565], Evans, Mark L [0000-0001-8122-8987], Amiel, Stephanie A [0000-0003-2686-5531], Pedersen-Bjergaard, Ulrik [0000-0003-0588-4880], de Galan, Bastiaan E [0000-0002-1255-7741], and Apollo - University of Cambridge Repository

Subjects
Blood Glucose, Male, Epinephrine, Hydrocortisone, Diabetes, Hypoglycemia, Norepinephrine, Counterregulatory hormones, Diabetes Mellitus, Type 1, Hyperinsulinaemic–hypoglycaemic stepped clamp, Growth Hormone, Glycaemic thresholds, Humans, Hypoglycemic Agents, Insulin, Female, Symptomatic responses, Systematic review, Hypoglycaemia, Human
Abstract

AIM/HYPOTHESIS: The physiological counterregulatory response to hypoglycaemia is reported to be organised hierarchically, with hormone responses usually preceding symptomatic awareness and autonomic responses preceding neuroglycopenic responses. To compare thresholds for activation of these responses more accurately between people with or without type 1 diabetes, we performed a systematic review on stepped hyperinsulinaemic-hypoglycaemic glucose clamps. METHODS: A literature search in PubMed and EMBASE was conducted. We included articles published between 1980 and 2018 involving hyperinsulinaemic stepped hypoglycaemic glucose clamps among people with or without type 1 diabetes. Key exclusion criteria were as follows: data were previously published; other patient population; a clamp not the primary intervention; and an inadequate clamp description. Glycaemic thresholds for counterregulatory hormone and/or symptom responses to hypoglycaemia were estimated and compared using generalised logrank test for interval-censored data, where the intervals were either extracted directly or calculated from the data provided by the study. A glycaemic threshold was defined as the glucose level at which the response exceeded the 95% CI of the mean baseline measurement or euglycaemic control clamp. Because of the use of interval-censored data, we described thresholds using median and IQR. RESULTS: A total of 63 articles were included, whereof 37 papers included participants with type 1 diabetes (n=559; 67.4% male sex, aged 32.7±10.2 years, BMI 23.8±1.4 kg/m2) and 51 papers included participants without diabetes (n=733; 72.4% male sex, aged 31.1±9.2 years, BMI 23.6±1.1 kg/m2). Compared with non-diabetic control individuals, in people with type 1 diabetes, the median (IQR) glycaemic thresholds for adrenaline (3.8 [3.2-4.2] vs 3.4 [2.8-3.9 mmol/l]), noradrenaline (3.2 [3.2-3.7] vs 3.0 [2.8-3.1] mmol/l), cortisol (3.5 [3.2-4.2]) vs 2.8 [2.8-3.4] mmol/l) and growth hormone (3.8 [3.3-3.8] vs. 3.2 [3.0-3.3] mmol/l) all occurred at lower glucose levels in people with diabetes than in those without diabetes (all p≤0.01). Similarly, although both autonomic (median [IQR] 3.4 [3.4-3.4] vs 3.0 [2.8-3.4] mmol/l) and neuroglycopenic (median [IQR] 3.4 [2.8-N/A] vs 3.0 [3.0-3.1] mmol/l) symptom responses were elicited at lower glucose levels in people with type 1 diabetes, the thresholds for autonomic and neuroglycopenic symptoms did not differ for each individual subgroup. CONCLUSIONS/INTERPRETATION: People with type 1 diabetes have glycaemic thresholds for counterregulatory hormone and symptom responses at lower glucose levels than people without diabetes. Autonomic and neuroglycopenic symptoms responses are generated at about similar levels of hypoglycaemia. There was a considerable variation in the methodology of the articles and the high insulin doses in most of the clamps may affect the counterregulatory responses. FUNDING: This article has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement no. 777460. REGISTRATION: This systematic review is registered in PROSPERO (CRD42019120083).

Published
2022
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