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7. Major mistakes or errors in the use of trial sequential analysis in systematic reviews or meta-analyses – the METSA systematic review

Author

Riberholt, Christian Gunge, Olsen, Markus Harboe, Milan, Joachim Birch, Hafliðadóttir, Sigurlaug Hanna, Svanholm, Jeppe Houmann, Pedersen, Elisabeth Buck, Lew, Charles Chin Han, Asante, Mark Aninakwah, Pereira Ribeiro, Johanne, Wagner, Vibeke, Kumburegama, Buddheera W. M. B., Lee, Zheng-Yii, Schaug, Julie Perrine, Madsen, Christina, and Gluud, Christian

Published
2024
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10. Prompt closure versus gradual weaning of external ventricular drain for hydrocephalus following aneurysmal subarachnoid haemorrhage: a statistical analysis plan for the DRAIN randomised clinical trial

Author

Capion, Tenna, Lilja-Cyron, Alexander, Juhler, Marianne, Møller, Kirsten, Sorteberg, Angelika, Rønning, Pål André, Poulsen, Frantz Rom, Wismann, Joakim, Schack, Anders Emil, Ravlo, Celina, Isaksen, Jørgen, Lindschou, Jane, Gluud, Christian, Mathiesen, Tiit, and Olsen, Markus Harboe

Published
2024
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15. One-step laparoscopic cholecystectomy with common bile duct exploration and stone extraction versus two-step endoscopic retrograde cholangiography with stone extraction plus laparoscopic cholecystectomy for patients with common bile duct stones: a randomised feasibility and pilot clinical trial—the preGallStep trial

Author

Kirkegaard-Klitbo, Anders, Shabanzadeh, Daniel Mønsted, Olsen, Markus Harboe, Lindschou, Jane, Gluud, Christian, and Sørensen, Lars Tue

Published
2023
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19. Adverse events in cognitive behavioral therapy and relaxation training for children and adolescents with obsessive-compulsive disorder: A mixed methods study and analysis plan for the TECTO trial

Author

Pretzmann, Linea, Christensen, Sofie Heidenheim, Bryde Christensen, Anne, Funch Uhre, Camilla, Uhre, Valdemar, Thoustrup, Christine Lykke, Clemmesen, Iben Thiemer, Gudmandsen, Tin Aaen, Korsbjerg, Nicoline Løcke Jepsen, Mora-Jensen, Anna-Rosa Cecilie, Ritter, Melanie, Olsen, Markus Harboe, Clemmensen, Line Katrine Harder, Lindschou, Jane, Gluud, Christian, Thomsen, Per Hove, Vangkilde, Signe, Hagstrøm, Julie, Rozental, Alexander, Jeppesen, Pia, Verhulst, Frank, Hybel, Katja Anna, Lønfeldt, Nicole Nadine, Plessen, Kerstin Jessica, Poulsen, Stig, and Pagsberg, Anne Katrine

Published
2023
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20. Quality of life, patient satisfaction, and cardiovascular outcomes of the randomised 2 x 3 factorial Copenhagen insulin and Metformin therapy (CIMT) trial – A detailed statistical analysis plan

Author

Olsen, Markus Harboe, Almdal, Thomas P., Madsbad, Sten, Ovesen, Christian, Gluud, Christian, Sneppen, Simone B., Breum, Leif, Hedetoft, Christoffer, Krarup, Thure, Lundby-Christensen, Louise, Mathiesen, Elisabeth R., Røder, Michael E., Vestergaard, Henrik, Wiinberg, Niels, and Jakobsen, Janus C.

Published
2023
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21. Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents (the TECTO trial): a statistical analysis plan for the randomised clinical trial

Author

Olsen, Markus Harboe, Hagstrøm, Julie, Lønfeldt, Nicole Nadine, Uhre, Camilla, Uhre, Valdemar, Pretzmann, Linea, Christensen, Sofie Heidenheim, Thoustrup, Christine, Korsbjerg, Nicoline Løcke Jepsen, Mora-Jensen, Anna-Rosa Cecilie, Ritter, Melanie, Engstrøm, Janus, Lindschou, Jane, Siebner, Hartwig Roman, Verhulst, Frank, Jeppesen, Pia, Jepsen, Jens Richardt Møllegaard, Vangkilde, Signe, Thomsen, Per Hove, Hybel, Katja, Clemmesen, Line Katrine Harder, Gluud, Christian, Plessen, Kerstin Jessica, Pagsberg, Anne Katrine, and Jakobsen, Janus Christian

Published
2022
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24. Correction: Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents: protocol for a randomised clinical trial (the TECTO trial)

Author

Pagsberg, Anne Katrine, Uhre, Camilla, Uhre, Valdemar, Pretzmann, Linea, Christensen, Sofie Heidenheim, Thoustrup, Christine, Clemmesen, Iben, Gudmandsen, Amanda Aaen, Korsbjerg, Nicoline Løcke Jepsen, Mora-Jensen, Anna-Rosa Cecilie, Ritter, Melanie, Thorsen, Emilie D., Halberg, Klara Sofie Vangstrup, Bugge, Birgitte, Staal, Nina, Ingstrup, Helga Kristensen, Moltke, Birgitte Borgbjerg, Kloster, Anne Murphy, Zoega, Pernille Juul, Mikkelsen, Marie Sommer, Harboe, Gitte Sommer, Larsen, Katrin Frimann, Clemmensen, Line Katrine Harder, Lindschou, Jane, Jakobsen, Janus Christian, Engstrøm, Janus, Gluud, Christian, Siebner, Hartwig Roman, Thomsen, Per Hove, Hybel, Katja, Verhulst, Frank, Jeppesen, Pia, Jepsen, Jens Richardt Møllegaard, Vangkilde, Signe, Olsen, Markus Harboe, Hagstrøm, Julie, Lønfeldt, Nicole Nadine, and Plessen, Kerstin Jessica

Published
2022
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26. Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents: protocol for a randomised clinical trial (the TECTO trial)

Author

Pagsberg, Anne Katrine, Uhre, Camilla, Uhre, Valdemar, Pretzmann, Linea, Christensen, Sofie Heidenheim, Thoustrup, Christine, Clemmesen, Iben, Gudmandsen, Amanda Aaen, Korsbjerg, Nicoline Løcke Jepsen, Mora-Jensen, Anna-Rosa Cecilie, Ritter, Melanie, Thorsen, Emilie D., Halberg, Klara Sofie Vangstrup, Bugge, Birgitte, Staal, Nina, Ingstrup, Helga Kristensen, Moltke, Birgitte Borgbjerg, Kloster, Anne Murphy, Zoega, Pernille Juul, Mikkelsen, Marie Sommer, Harboe, Gitte Sommer, Larsen, Katrin Frimann, Clemmesen, Line Katrine Harder, Lindschou, Jane, Jakobsen, Janus Christian, Engstrøm, Janus, Gluud, Christian, Siebner, Hartwig Roman, Thomsen, Per Hove, Hybel, Katja, Verhulst, Frank, Jeppesen, Pia, Jepsen, Jens Richardt Møllegaard, Vangkilde, Signe, Olsen, Markus Harboe, Hagstrøm, Julie, Lønfeldt, Nicole Nadine, and Plessen, Kerstin Jessica

Published
2022
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29. Liraglutide enhances insulin secretion and prolongs the remission period in adults with newly diagnosed type 1 diabetes (the NewLira study): A randomized, double‐blind, placebo‐controlled trial.

Author

Dejgaard, Thomas F., Frandsen, Christian S., Kielgast, Urd, Størling, Joachim, Overgaard, Anne J., Svane, Maria S., Olsen, Markus Harboe, Thorsteinsson, Birger, Andersen, Henrik U., Krarup, Thure, Holst, Jens J., and Madsbad, Sten

Subjects
TYPE 1 diabetes, GLYCEMIC control, INSULIN therapy, LIRAGLUTIDE, HYPOGLYCEMIA
Abstract

Aim: To test the effect of the glucagon‐like peptide‐1 receptor agonist, liraglutide, on residual beta‐cell function in adults with newly diagnosed type 1 diabetes. Materials and Methods: In a multicentre, double‐blind, parallel‐group trial, adults with newly diagnosed type 1 diabetes and stimulated C‐peptide of more than 0.2 nmol/L were randomized (1:1) to 1.8‐mg liraglutide (Victoza) or placebo once daily for 52 weeks with 6 weeks of follow‐up with only insulin treatment. The primary endpoint was the between‐group difference in C‐peptide area under the curve (AUC) following a liquid mixed‐meal test after 52 weeks of treatment. Results: Sixty‐eight individuals were randomized. After 52 weeks, the 4‐hour AUC C‐peptide response was maintained with liraglutide, but decreased with placebo (P =.002). Six weeks after end‐of‐treatment, C‐peptide AUCs were similar for liraglutide and placebo. The average required total daily insulin dose decreased from 0.30 to 0.23 units/kg/day with liraglutide, but increased from 0.29 to 0.43 units/kg/day in the placebo group at week 52 (P <.001). Time without the need for insulin treatment was observed in 13 versus two patients and lasted for 22 weeks (from 3 to 52 weeks) versus 6 weeks (from 4 to 8 weeks) on average for liraglutide and placebo, respectively. Patients treated with liraglutide had fewer episodes of hypoglycaemia compared with placebo‐treated patients. The adverse events with liraglutide were predominantly gastrointestinal and transient. Conclusions: Treatment with liraglutide improves residual beta‐cell function and reduces the dose of insulin during the first year after diagnosis. Beta‐cell function was similar at 6 weeks postliraglutide treatment. [ABSTRACT FROM AUTHOR]

Published
2024
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30. Opioids and personalized analgesia in the perioperative setting: A protocol for five systematic reviews.

Author

Karlsen, Anders Peder Højer, Sunde, Pernille Bjersand, Olsen, Markus Harboe, Laigaard, Jens, Folkersen, Caroline, Tran, Trang Xuan Minh, Rasmussen, Ida Houtved, Kjartansdóttir, Selma, Saito, Atena, Andersen, Michael Asger, Maagaard, Mathias, Papadomanolakis‐Pakis, Nicholas, Dalhoff, Kim, Nikolajsen, Lone, Lunn, Troels Haxholdt, Meyhoff, Christian Sylvest, Jakobsen, Janus Christian, and Mathiesen, Ole

Subjects
PAIN management, PERIOPERATIVE care, POSTOPERATIVE pain, OPIOIDS, PHARMACOGENOMICS
Abstract

Background: Treatment with opioids is a mainstay in perioperative pain management. While the leading treatment paradigm has been procedure‐specific pain management, efforts regarding personalized pain treatment are increasing. The OPI•AID project aims to develop personalized algorithms for perioperative pain management, taking demographic, surgical, and anaesthesiologic factors into account. We will undertake five parallel reviews to illuminate current evidence on different aspects of individual responses to perioperative opioid treatment. Methods: Inclusion of adult populations in English‐written studies. Review‐specific searches are developed for the following databases: CENTRAL, MEDLINE, Embase, clinicaltrials.gov, and clinicaltrial.eu. Two authors will independently screen citations, extract data, and assess the risks of bias in each review (QUIPS, PROBAST and RoB2, as relevant). Conclusion: These reviews will evaluate various aspects of perioperative opioid treatment, including individualized treatment strategies, selection of specific opioids, and individual patient responses. These will guide future development of a personalized perioperative opioid treatment algorithm (OPI•AID) that will be validated and tested clinically against standard of care. [ABSTRACT FROM AUTHOR]

Published
2024
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31. Arterial to jugular‐bulb lactate difference in patients undergoing elective brain tumor craniotomy.

Author

Vassilieva, Alexandra, Olsen, Markus Harboe, Skjøth‐Rasmussen, Jane, Møller, Kirsten, and Sørensen, Martin Kryspin

Subjects
*BRAIN tumors, *HYPERLACTATEMIA, *BRAIN cancer, *CRANIOTOMY, *LACTATES
Abstract

Hyperlactatemia is common during tumor craniotomy, but the underlying pathophysiology is unclear. This study measured simultaneous arterial and jugular‐bulb lactate concentrations in patients undergoing brain tumor craniotomy to investigate the hypothesis that hyperlactatemia was associated with a net cerebrovascular lactate input. In 20 patients, arterial and jugular‐bulb blood was collected hourly from the start of surgery to 6 h postoperatively for measurement of lactate, glucose, and oxygen concentration. For each marker, data were analyzed using a linear mixed‐effects model with jugular‐bulb concentration as dependent variable, arterial concentration as fixed effect, and patient as random effect. Furthermore, we generated regression lines between arterial and jugular‐bulb concentrations. The slope of the regression line between arterial and jugular‐bulb lactate was 0.95 (95% CI 0.93–0.97, R2 = 0.98), indicating that increasing arterial lactate levels were associated with an increasingly positive net cerebrovascular balance (net input). The line crossed the identity line at 2.86 (95% CI 0.57–5.16) mmol/L, indicating that lower levels of lactate were associated with a negative net cerebrovascular balance (net output). This suggests a switch from net lactate output during normolactatemia towards net input during hyperlactatemia. Hyperlactatemia in tumor‐craniotomy patients probably does not originate from the brain. [ABSTRACT FROM AUTHOR]

Published
2024
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36. Myths and methodologies:Assessment of dynamic cerebral autoregulation by the mean flow index

Author

Olsen, Markus Harboe, Riberholt, Christian Gunge, Berg, Ronan M. G., Møller, Kirsten, Olsen, Markus Harboe, Riberholt, Christian Gunge, Berg, Ronan M. G., and Møller, Kirsten

Abstract

The mean flow index—usually referred to as Mx—has been used for assessing dynamic cerebral autoregulation (dCA) for almost 30 years. However, concerns have arisen regarding methodological consistency, construct and criterion validity, and test–retest reliability. Methodological nuances, such as choice of input (cerebral perfusion pressure, invasive or non-invasive arterial pressure), pre-processing approach and artefact handling, significantly influence mean flow index values, and previous studies correlating mean flow index with other established dCA metrics are confounded by inherent methodological flaws like heteroscedasticity, while the mean flow index also fails to discriminate individuals with presumed intact versus impaired dCA (discriminatory validity), and its prognostic performance (predictive validity) across various conditions remains inconsistent. The test–retest reliability, both within and between days, is generally poor. At present, no single approach for data collection or pre-processing has proven superior for obtaining the mean flow index, and caution is advised in the further use of mean flow index-based measures for assessing dCA, as current evidence does not support their clinical application., The mean flow index-usually referred to as Mx-has been used for assessing dynamic cerebral autoregulation (dCA) for almost 30 years. However, concerns have arisen regarding methodological consistency, construct and criterion validity, and test-retest reliability. Methodological nuances, such as choice of input (cerebral perfusion pressure, invasive or non-invasive arterial pressure), pre-processing approach and artefact handling, significantly influence mean flow index values, and previous studies correlating mean flow index with other established dCA metrics are confounded by inherent methodological flaws like heteroscedasticity, while the mean flow index also fails to discriminate individuals with presumed intact versus impaired dCA (discriminatory validity), and its prognostic performance (predictive validity) across various conditions remains inconsistent. The test-retest reliability, both within and between days, is generally poor. At present, no single approach for data collection or pre-processing has proven superior for obtaining the mean flow index, and caution is advised in the further use of mean flow index-based measures for assessing dCA, as current evidence does not support their clinical application.

Published
2024

37. Urokinase Plasminogen Activator Receptor:An Important Focal Player in Chronic Subdural Hematoma?

Author

Jensen, Thorbjørn Søren Rønn, Olsen, Markus Harboe, Lelkaitis, Giedrius, Kjaer, Andreas, Binderup, Tina, Fugleholm, Kåre, Jensen, Thorbjørn Søren Rønn, Olsen, Markus Harboe, Lelkaitis, Giedrius, Kjaer, Andreas, Binderup, Tina, and Fugleholm, Kåre

Abstract

Chronic subdural hematoma (CSDH) development involves inflammatory, angiogenetic, and fibrinolytic mechanisms, several components of which are now unraveled through intensive research. The urokinase plasminogen activator receptor (uPAR) is part of the plasminogen activator system and possesses inflammatory, angiogenetic, and fibrinolytic capabilities. As a first, this study aims to identify uPAR in the hematoma fluid, hematoma membrane, dura mater, and systemic blood from patients with CSDH and, if present, to investigate if the uPAR level at the time of surgery may be a predictor for later developing recurrent CSDH. uPAR expression in the hematoma membrane and dura mater was analyzed using immunohistochemistry and presented as the H-score of the positive immunostaining. The uPAR levels in the hematoma fluid and systemic blood were determined using a multiplex antibody bead kit (Luminex). Samples were collected at the time of the first CSDH surgery, and in the case of recurrent CSDH within 90 days, the samples were again collected at reoperation. A comparison of uPAR expression between the hematoma membrane and dura mater, as well as uPAR levels in systemic blood and hematoma fluid, was performed using the Wilcoxon rank sum test. We included 112 patients, 26 of whom had recurrent CSDH. The median hematoma uPAR level was 22,125 (14,845–33,237) and significantly higher than the median systemic blood level of 789 pg/L (465–2,088) (p < 0.001). Similarly, the uPAR level of the hematoma membrane was 14.3 (7.54–44.8) and significantly higher than the dural uPAR level of 0.81 (0.3–1.98) (p < 0.001). For the first time, we identified uPAR in the subdural fluid, hematoma membrane, dura mater, and systemic blood from patients with CSDH. The high expression of uPAR in the subdural fluid and hematoma membrane indicates that the mechanisms of CSDH are predominantly in the subdural fluid collection and surrounding hematoma membrane.

Published
2024

38. Near-infrared spectroscopy to measure brain oxygenation:A comparison of measurements on the skin, skull and dura mater

Author

Pedersen, Sofie S., Sørensen, Martin Kryspin, Olsen, Markus Harboe, Stisen, Zara R., Lund, Anton, Møller, Kirsten, Skjøth-Rasmussen, Jane, Moltke, Finn B., Meyhoff, Christian S., Pedersen, Sofie S., Sørensen, Martin Kryspin, Olsen, Markus Harboe, Stisen, Zara R., Lund, Anton, Møller, Kirsten, Skjøth-Rasmussen, Jane, Moltke, Finn B., and Meyhoff, Christian S.

Abstract

Background The reliability of near-infrared spectroscopy (NIRS) for measuring cerebral oxygenation (ScO2) is controversial due to the possible contamination from extracranial tissues. We compared ScO2 measured with the NIRS optode on the forehead, the skull and the dura mater in anaesthetised patients undergoing craniotomy. We hypothesised that ScO2 measured directly on the skull and the dura mater would differ from ScO2 measured on the skin. Methods This prospective observational study included 17 adult patients scheduled for elective craniotomy. After induction of general anaesthesia, ScO2 was measured on the forehead skin, as well as on the skull and on the dura mater in the surgical field. The primary comparison was the difference in ScO2 measured on the dura mater and on ScO2 measured on the skin; secondary comparisons were the differences in ScO2 on the skull and ScO2 on the skin and the dura mater, respectively. Data were described with median (5%–95% range) and analysed with the Wilcoxon signed-rank test. Results ScO2 values on the dura mater were obtained in 11 patients, and median ScO2 (48%, 29%–95%) did not differ significantly from ScO2 on the skin (73%, 49%–92%; p = .052), median difference −25% (−35.6% to −1.2%). ScO2 on the skull (N = 16) was lower than that on the skin (63% [43%–79%] vs. 75% [61%–94%]; p = .0002), median difference −10% (−20.8 to −3.0). Conclusion In adults undergoing craniotomy, NIRS-based ScO2 measured on the dura mater did not reach statistically significantly lower values than ScO2 measured on the skin, whereas values on the skull were lower than on the skin, indicating a contribution from scalp tissue to the signal., Background: The reliability of near-infrared spectroscopy (NIRS) for measuring cerebral oxygenation (ScO2) is controversial due to the possible contamination from extracranial tissues. We compared ScO2 measured with the NIRS optode on the forehead, the skull and the dura mater in anaesthetised patients undergoing craniotomy. We hypothesised that ScO2 measured directly on the skull and the dura mater would differ from ScO2 measured on the skin. Methods: This prospective observational study included 17 adult patients scheduled for elective craniotomy. After induction of general anaesthesia, ScO2 was measured on the forehead skin, as well as on the skull and on the dura mater in the surgical field. The primary comparison was the difference in ScO2 measured on the dura mater and on ScO2 measured on the skin; secondary comparisons were the differences in ScO2 on the skull and ScO2 on the skin and the dura mater, respectively. Data were described with median (5%–95% range) and analysed with the Wilcoxon signed-rank test. Results: ScO2 values on the dura mater were obtained in 11 patients, and median ScO2 (48%, 29%–95%) did not differ significantly from ScO2 on the skin (73%, 49%–92%; p =.052), median difference −25% (−35.6% to −1.2%). ScO2 on the skull (N = 16) was lower than that on the skin (63% [43%–79%] vs. 75% [61%–94%]; p =.0002), median difference −10% (−20.8 to −3.0). Conclusion: In adults undergoing craniotomy, NIRS-based ScO2 measured on the dura mater did not reach statistically significantly lower values than ScO2 measured on the skin, whereas values on the skull were lower than on the skin, indicating a contribution from scalp tissue to the signal.

Published
2024

39. Research Note: Trial sequential analysis in systematic reviews with meta-analysis.

Author

Riberholt, Christian Gunge, Olsen, Markus Harboe, and Gluud, Christian

Subjects
PHYSICAL therapy, MEDICAL research
Abstract

The article explores trial sequential analysis (TSA) as a method to mitigate type I and type II errors in meta-analyses by adjusting significance levels based on acquired versus required information sizes. It discusses the application of TSA to improve precision in systematic reviews, highlighting its use in controlling random errors and determining boundaries for beneficial, harmful, and futile effects before reaching the required information size.

Published
2024
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50. Major Mistakes or Errors in the use of Trial Sequential Analysis in Systematic Reviews or Meta-analyses – the METSA Systematic Review

Author

Riberholt, Christian Gunge, primary, Olsen, Markus Harboe, additional, Milan, Joachim Birch, additional, Hafliðadóttir, Sigurlaug Hanna, additional, Svanholm, Jeppe Houmann, additional, Pedersen, Elisabeth Buck, additional, Lew, Charles Chin Han, additional, Asante, Mark Aninakwah, additional, Ribeiro, Johanne Pereira, additional, Wagner, Vibeke, additional, Kumburegama, Buddheera W.M.B., additional, Lee, Zheng-Yii, additional, Schaug, Julie Perrine, additional, Madsen, Christina, additional, and Gluud, Christian, additional

Published
2023
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