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Journal articles on the topic 'Randomised controlled crossover trial'

Author: Grafiati

Published: 10 January 2023

Last updated: 28 January 2023

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1

Investigators, *The SuDDICU, Laurent Billot, Brian Cuthbertson, Anthony Gordon, Farah Al-Beidh, Maryam Correa, Joshua Davis, et al. "Protocol summary and statistical analysis plan for the Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients (SuDDICU) crossover, cluster randomised controlled trial." Critical Care and Resuscitation 23, no. 2 (June 7, 2021): 183–93. http://dx.doi.org/10.51893/2021.2.oa5.

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Background: It is unclear whether the use of selective decontamination of the digestive tract (SDD) improves outcomes in ventilated patients in intensive care units (ICUs) and whether SDD is associated with the development of antibiotic resistance. Objective: To describe the study protocol and statistical analysis plan for the Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients (SuDDICU) trial. Design, setting, participants and intervention: SuDDICU is an international, crossover, cluster randomised controlled trial of mechanically ventilated patients in ICUs using two 12-month trial periods. For each period, participating ICUs will implement SDD plus standard care or standard care alone. The SuDDICU drug intervention is an oral paste and gastric suspension of three antibiotics combined with a 4-day course of intravenous antibiotics. Observational ecological assessments will be conducted during five surveillance periods. The trial will be conducted in 19 ICUs in Australia and ten ICUs in Canada and the United Kingdom, and will recruit 15 000–17 000 patients. Recruitment commenced in Australia in 2017. Main outcome measures: The primary outcome is all-cause hospital mortality. Secondary outcomes include: duration of ventilation, ICU stay and hospital stay; incidence of new antibiotic-resistant organisms during the index ICU admission; changes in antibiotic-resistant organism rates; incidence of new Clostridioides difficile infections; and total use of antibiotics. Results and conclusions: SuDDICU will determine whether the use of SDD plus standard care is associated with a reduction in hospital mortality in ventilated ICU patients compared with standard care alone. It will also quantify the impact of the use of SDD on the development of antibiotic resistance. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12615000411549) and ClinicalTrials.gov (NCT02389036).

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Kaushal, Prachi, Sherna F. Adenwalla, Courtney J. Lightfoot, Daniel S. March, Laura J. Gray, and James O. Burton. "Evaluation of the design, conduct and reporting of randomised controlled trials in the haemodialysis population: a scoping review and interview study." BMJ Open 12, no. 3 (March 2022): e058368. http://dx.doi.org/10.1136/bmjopen-2021-058368.

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BackgroundFewer trials are conducted in nephrology than any other specialty, often failing to recruit to target, resulting in unclear evidence affecting translation to clinical practice. This mixed-methods study aims to provide guidance for designing and reporting future randomised controlled trials (RCTs) in the haemodialysis population.MethodA scoping review was conducted. Five databases (MEDLINE, Cumulative Index to Nursing and Allied Health Literature, Embase, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov) were searched for RCTs published between 2013 and 2019 involving prevalent adult haemodialysis patients. Reporting of sample size, recruitment, retention and statistical significance of primary outcome were assessed. Face-to-face semistructured interviews were conducted with individuals from a single centre during dialysis sessions. Interviews were analysed thematically.ResultsOf 786 RCTs identified, 636 (80.9%) were parallel-group, 139 (17.7%) were crossover and 11 (1.4%) were cluster (including one stepped-wedge) design. Sample size justification was reported in 73.1%, 53.8% and 45.5% of parallel-group, crossover and cluster trials, respectively.Target recruitment was achieved by 45.5% of cluster, 53.8% of crossover and 57.7% of parallel-group trials with patient retention at 75.6%, 83.1% and 87.8%, respectively. Primary outcome reached statistical significance in 81.8% of cluster trials, 69.2% of parallel-group and 38.5% of crossover trials.Themes identified from individual interviews: perceptions of the convenience of trial participation; group allocation; perceptions of the benefits and adverse effects of taking part in clinical trials.ConclusionThe recruitment and reporting of RCTs involving people on haemodialysis could be improved. Involvement of all stakeholders and especially participants in the trial design process may address issues around participant burden and ultimately improve the evidence base for clinical practice.

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Dalbeth, N., S. Wong, G. D. Gamble, A. Horne, B. Mason, B. Pool, L. Fairbanks, et al. "Acute effect of milk on serum urate concentrations: a randomised controlled crossover trial." Annals of the Rheumatic Diseases 69, no. 9 (May 14, 2010): 1677–82. http://dx.doi.org/10.1136/ard.2009.124230.

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Lenhardt, R. "Local warming and insertion of peripheral venous cannulas: single blinded prospective randomised controlled trial and single blinded randomised crossover trial." BMJ 325, no. 7361 (August 24, 2002): 409. http://dx.doi.org/10.1136/bmj.325.7361.409.

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de Ruijter, Jessica, Marlies J. Valstar, Magdalena Narajczyk, Grzegorz Wegrzyn, Wim Kulik, Lodewijk IJlst, Tom Wagemans, Willem M. van der Wal, and Frits A. Wijburg. "Genistein in Sanfilippo disease: A randomized controlled crossover trial." Annals of Neurology 71, no. 1 (January 2012): 110–20. http://dx.doi.org/10.1002/ana.22643.

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Blackston, J., Andrew Chapple, James McGree, Suzanne McDonald, and Jane Nikles. "Comparison of Aggregated N-of-1 Trials with Parallel and Crossover Randomized Controlled Trials Using Simulation Studies." Healthcare 7, no. 4 (November 6, 2019): 137. http://dx.doi.org/10.3390/healthcare7040137.

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Background: N-of-1 trials offer an innovative approach to delivering personalized clinical care together with population-level research. While increasingly used, these methods have raised some statistical concerns in the healthcare community. Methods: We discuss concerns of selection bias, carryover effects from treatment, and trial data analysis conceptually, then rigorously evaluate concerns of effect sizes, power and sample size through simulation study. Four variance structures for patient heterogeneity and model error are considered in a series of 5000 simulated trials with 3 cycles, which compare aggregated N-of-1 trials to parallel randomized controlled trials (RCTs) and crossover trials. Results: Aggregated N-of-1 trials outperformed both traditional parallel RCT and crossover designs when these trial designs were simulated in terms of power and required sample size to obtain a given power. N-of-1 designs resulted in a higher type-I error probability than parallel RCT and cross over designs when moderate-to-strong carryover effects were not considered or in the presence of modeled selection bias. However, N-of-1 designs allowed better estimation of patient-level random effects. These results reinforce the need to account for these factors when planning N-of-1 trials. Conclusion: N-of-1 trial designs offer a rigorous method for advancing personalized medicine and healthcare with the potential to minimize costs and resources. Interventions can be tested with adequate power with far fewer patients than traditional RCT and crossover designs. Operating characteristics compare favorably to both traditional RCT and crossover designs.

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Equi, A., IM Balfour-Lynn, A. Bush, and M. Rosenthal. "Long term azithromycin in children with cystic fibrosis: a randomised, placebo-controlled crossover trial." Lancet 360, no. 9338 (September 2002): 978–84. http://dx.doi.org/10.1016/s0140-6736(02)11081-6.

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Dellemijn, Paul LI, and Jan AL Vanneste. "Randomised double-blind active-placebo-controlled crossover trial of intravenous fentanyl in neuropathic pain." Lancet 349, no. 9054 (March 1997): 753–58. http://dx.doi.org/10.1016/s0140-6736(96)09024-1.

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Collister, David, Kayla Pohl, Gwen Herrington, Shun Fu Lee, Christian Rabbat, Karthik Tennankore, Deborah Zimmermann, et al. "The DIalysis Symptom COntrol-Restless Legs Syndrome (DISCO-RLS) Trial: A Protocol for a Randomized, Crossover, Placebo-Controlled Blinded Trial." Canadian Journal of Kidney Health and Disease 7 (January 2020): 205435812096895. http://dx.doi.org/10.1177/2054358120968959.

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Background: Restless legs syndrome (RLS) affects approximately 30% of patients with end-stage kidney disease and is associated with impaired sleep and health-related quality of life. Medications used to treat RLS in patients receiving dialysis may have an increased risk of adverse events with dose titration, and residual RLS symptoms are common despite the use of effective treatments. Randomized controlled trials of monotherapy and combination pharmacologic therapy for RLS in hemodialysis are needed. Objective: To perform a randomized, crossover, placebo-controlled blinded trial of pharmacologic therapy for RLS in hemodialysis. Design/setting: The DIalysis Symptom COntrol-Restless Legs Syndrome (DISCO-RLS) trial is a randomized, crossover, placebo-controlled blinded trial of fixed low-dose pharmacologic therapy in patients receiving hemodialysis in 10 centers across Canada. It uses patient partners in its design, conduct, and reporting. Participants: Adults receiving thrice-weekly hemodialysis for at least 3 months with RLS of at least mild symptoms defined International Restless Legs Syndrome Study Group Rating Scale (IRLS) of 10 or more will enter a double placebo run-in period to exclude nonadherent participants and those unable to tolerate double placebo. Seventy-two participants who completed the run-in period will be randomized to 1 of 8 treatment sequences based on modeling with 4 treatment periods. Methods: Each treatment period lasts 4 weeks and consists of ropinirole 0.5 mg daily and gabapentin 100 mg daily, both together or neither with a double dummy placebo control for each treatment. The primary outcome is the difference in change scores of the IRLS between study treatments. Secondary outcomes are the differences in change scores of the Restless Legs Syndrome-6 Scale, patient global impression, 5-level EQ-5D version, and safety outcomes. Results: This randomized, crossover, placebo-controlled blinded trial will evaluate the efficacy and safety of fixed low-dose combination of ropinirole and gabapentin in patients receiving hemodialysis with RLS. Limitations: Patients with chronic kidney disease not on dialysis, kidney transplant recipients and those receiving peritoneal dialysis or home hemodialysis are not included. The intervention’s long term safety and efficacy including the risk of augmentation is not captured. Conclusion: This randomized crossover placebo controlled blinded trial will evaluate the efficacy and safety of fixed low-dose combination ropinirole and gabapentin in patients receiving hemodialysis with RLS. Trial Registration: ClinicalTrials.gov (NCT03806530)

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Rowsell, Luke, Keith K. H. Wong, Brendon J. Yee, Danny J. Eckert, Andrew A. Somogyi, James Duffin, Ronald R. Grunstein, and David Wang. "The effect of acute morphine on obstructive sleep apnoea: a randomised double-blind placebo-controlled crossover trial." Thorax 74, no. 2 (August 30, 2018): 177–84. http://dx.doi.org/10.1136/thoraxjnl-2018-211675.

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ObjectiveAnaesthesiology guidelines suggest that opioids worsen obstructive sleep apnoea (OSA) despite no randomised controlled trial evidence. We therefore conducted a randomised controlled trial to evaluate the effects of a common clinical dose of morphine on OSA, and to identify clinical phenotype and genotype vulnerability to opioid-respiratory depression.MethodsUnder a double-blind, randomised, crossover design, 60 male patients with OSA attended two visits to the hospital sleep laboratory, at least 1 week apart. Either 40 mg controlled-release oral morphine or placebo was administered. Awake ventilatory chemoreflex tests were performed post dose and prior to overnight polysomnography monitoring. Blood was sampled before sleep and the next morning for toxicology and genotype analyses. Sleep time with oxygen saturation (SpO2) <90% (T90) was the primary outcome.ResultsDespite a large inter-individual variability, 40 mg morphine did not worsen T90 and apnoea–hypopnoea index, and only decreased the SpO2 nadir by 1.3%. In patients with severe OSA, a lower baseline CO2ventilatory response threshold correlated with the worsening of T90, apnoea–hypopnoea index and oxygen desaturation index with morphine use. Patients with OSA and the A118G OPRM1 polymorphism of A/A and A/G had a significantly different morphine effect on awake ventilatory chemosensitivity and T90 during sleep.Conclusions40 mg oral controlled-release morphine did not worsen OSA in men, challenging traditional thinking that OSA will be worsened by opioids. Individual opioid response in patients with OSA may relate to baseline CO2 response threshold and OPRM1 genotype. Our study findings may pave the way for a precision medicine approach to avoid opioid-related risks.Trial registration numberThe Australian and New Zealand Clinical Trial Registry, ACTRN12613000858796.

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Hawwash, Dana, Melissa K. Sharp, Alemayehu Argaw, Patrick Kolsteren, and Carl Lachat. "Usefulness of applying research reporting guidelines as Writing Aid software: a crossover randomised controlled trial." BMJ Open 9, no. 11 (November 2019): e030943. http://dx.doi.org/10.1136/bmjopen-2019-030943.

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ObjectivesTo assess the intention of using a Writing Aid software, which integrates four research reporting guidelines (Consolidated Standards of Reporting Trials, Preferred Reporting Items for Systematic Reviews and Meta-Analyses, Strengthening the Reporting of Observational Studies in Epidemiology and STrengthening the Reporting of Observational Studies in Epidemiology-nutritional epidemiology) and their Elaboration & Explanation (E&E) documents during the write-up of research in Microsoft Word compared with current practices.DesignTwo-arms crossover randomised controlled trial with no blinding and no washout period.SettingFace-to-face or online sessions.Participants54 (28 in arm 1 and 26 in arm 2) doctoral and postdoctoral researchers.InterventionsReporting guidelines and their E&E document were randomly administered as Writing Aid or as Word documents in a single 30 min to 1 hour session, with a short break before crossing over to the other study intervention.Primary and secondary outcomesUsing the Technology Acceptance Model, we assessed the primary outcome: the difference in the mean of intention of use; and secondary outcomes: the difference in mean perceived ease of use and perceived usefulness. The three outcomes were measured using questions with a 7-point Likert-scale. Secondary analysis using structural equation modelling (SEM) was applied to explore the relationships between the outcomes.ResultsNo significant difference in reported intention of use (mean difference and 95% CI 0.25 (–0.05 to 0.55), p=0.10), and perceived usefulness (mean difference and 95% CI 0.19 (–0.04 to 0.41), p=0.10). The Writing Aid performed significantly better than the word document on researchers’ perceived ease of use (mean difference and 95% CI 0.59 (0.29 to 0.89), p<0.001). In the SEM analysis, participants’ intention of using the tools was indirectly affected by perceived ease of use (beta 0.53 p=0.002).ConclusionsDespite no significant difference in the intention of use between the tools, administering reporting guidelines as Writing Aid is perceived as easier to use, offering a possibility to further explore its applicability to enhance reporting adherence.

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Swift, Joshua K., Jennifer L. Callahan, Rose Dunn, Kierra Brecht, and Mariana Ivanovic. "A randomized-controlled crossover trial of mindfulness for student psychotherapists." Training and Education in Professional Psychology 11, no. 4 (November 2017): 235–42. http://dx.doi.org/10.1037/tep0000154.

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Katz, David L., Marian A. Evans, Haq Nawaz, Valentine Yanchou Njike, Wendy Chan, Beth Patton Comerford, and Martha L. Hoxley. "Egg consumption and endothelial function: a randomized controlled crossover trial." International Journal of Cardiology 99, no. 1 (March 2005): 65–70. http://dx.doi.org/10.1016/j.ijcard.2003.11.028.

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Aitken, D., L. L. Laslett, F. Pan, I. K. Haugen, P. Otahal, N. Bellamy, P. Bird, and G. Jones. "A randomised double-blind placebo-controlled crossover trial of HUMira (adalimumab) for erosive hand OsteoaRthritis – the HUMOR trial." Osteoarthritis and Cartilage 26, no. 7 (July 2018): 880–87. http://dx.doi.org/10.1016/j.joca.2018.02.899.

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Aitken, D., F. Pan, L. Laslett, N. Bellamy, P. Bird, I. Haugen, and G. Jones. "A randomised double-blind placebo-controlled crossover trial of humira (adalimumab) for erosive hand osteoarthritis: the humor trial." Osteoarthritis and Cartilage 25 (April 2017): S9. http://dx.doi.org/10.1016/j.joca.2017.02.032.

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Mine, Koya. "Acute Effects of Quick Short - Duration Massage On Vertical Jump; A Crossover Randomised Controlled Trial." Physical Medicine, Rehabilitation & Disabilities 3, no. 1 (June 8, 2017): 1–4. http://dx.doi.org/10.24966/pmrd-8670/100019.

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Patel, N. J., R. F. Lemanske, and J. MD. "Randomised Placebo-Controlled Crossover Trial on Effect ofInactivated Influenza Vaccine on Pulmonary Function in Asthma." PEDIATRICS 104, no. 2 (August 1, 1999): 376–77. http://dx.doi.org/10.1542/peds.104.2.s1.376a.

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Patel, Naresh J., Robert F. Lemanske, and Jr, MD. "Randomised Placebo-Controlled Crossover Trial on Effect ofInactivated Influenza Vaccine on Pulmonary Function in Asthma." Pediatrics 104, Supplement_2 (August 1, 1999): 376–77. http://dx.doi.org/10.1542/peds.104.s2.376b.

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Wilson, K. E., R. R. Welbury, and N. M. Girdler. "A randomised, controlled, crossover trial of oral midazolam and nitrous oxide for paediatric dental sedation." Anaesthesia 57, no. 9 (August 20, 2002): 860–67. http://dx.doi.org/10.1046/j.1365-2044.2002.02784.x.

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Wiles, C. M. "Controlled randomised crossover trial of the effects of physiotherapy on mobility in chronic multiple sclerosis." Journal of Neurology, Neurosurgery & Psychiatry 70, no. 2 (February 1, 2001): 174–79. http://dx.doi.org/10.1136/jnnp.70.2.174.

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Garcia-Perez, Isabel, Joram M. Posma, Rachel Gibson, Edward S. Chambers, Tue H. Hansen, Henrik Vestergaard, Torben Hansen, et al. "Objective assessment of dietary patterns by use of metabolic phenotyping: a randomised, controlled, crossover trial." Lancet Diabetes & Endocrinology 5, no. 3 (March 2017): 184–95. http://dx.doi.org/10.1016/s2213-8587(16)30419-3.

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Richmond, Stewart J., Sally R. Brown, Peter D. Campion, Amanda J. L. Porter, Jennifer A. Klaber Moffett, David A. Jackson, Valerie A. Featherstone, and Andrew J. Taylor. "Therapeutic effects of magnetic and copper bracelets in osteoarthritis: A randomised placebo-controlled crossover trial." Complementary Therapies in Medicine 17, no. 5-6 (October 2009): 249–56. http://dx.doi.org/10.1016/j.ctim.2009.07.002.

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Marshall, N. S. "Randomised controlled crossover trial of humidified continuous positive airway pressure in mild obstructive sleep apnoea." Thorax 60, no. 5 (May 1, 2005): 427–32. http://dx.doi.org/10.1136/thx.2004.032078.

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Vuillermin, P. J., C. F. Robertson, J. B. Carlin, S. L. Brennan, M. I. Biscan, and M. South. "Parent initiated prednisolone for acute asthma in children of school age: randomised controlled crossover trial." BMJ 340, mar01 1 (March 1, 2010): c843. http://dx.doi.org/10.1136/bmj.c843.

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Zoons, Evelien, Jan Booij, Catherine C. S. Delnooz, Joke M. Dijk, Yasmine E. M. Dreissen, Johannes H. T. M. Koelman, Sandra M. A. van der Salm, et al. "Randomised controlled trial of escitalopram for cervical dystonia with dystonic jerks/tremor." Journal of Neurology, Neurosurgery & Psychiatry 89, no. 6 (January 11, 2018): 579–85. http://dx.doi.org/10.1136/jnnp-2017-317352.

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ObjectiveTrials for additional or alternative treatments for cervical dystonia (CD) are scarce since the introduction of botulinum neurotoxin (BoNT). We performed the first trial to investigate whether dystonic jerks/tremor in patients with CD respond to the selective serotonin reuptake inhibitor (SSRI) escitalopram.MethodsIn a randomised, double-blind, crossover trial, patients with CD received escitalopram and placebo for 6 weeks. Treatment with BoNT was continued, and scores on rating scales regarding dystonia, psychiatric symptoms and quality of life (QoL) were compared. Primary endpoint was the proportion of patients that improved at least one point on the Clinical Global Impression Scale for jerks/tremor scored by independent physicians with experience in movement disorders.ResultsFifty-threepatients were included. In the escitalopram period, 14/49 patients (29%) improved on severity of jerks/tremor versus 11/48 patients (23%) in the placebo period (P=0.77). There were no significant differences between baseline and after treatment with escitalopram or placebo on severity of dystonia or jerks/tremor. Psychiatric symptoms and QoL improved significantly in both periods compared with baseline. There were no significant differences between treatment with escitalopram and placebo for dystonia, psychiatric or QoL rating scales. During treatment with escitalopram, patients experienced slightly more adverse events, but no serious adverse events occurred.ConclusionIn this innovative trial, no add-on effect of escitalopram for treatment of CD with jerks was found on motor or psychiatric symptoms. However, we also did not find a reason to withhold patients treatment with SSRIs for depression and anxiety, which are common in dystonia.Trial registration numberNTR2178.

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Al-Chalabi, Ammar, Pamela Shaw, P. Nigel Leigh, Leonard van den Berg, Orla Hardiman, Albert Ludolph, Valtteri V. Aho, Toni Sarapohja, and Mikko Kuoppamäki. "Oral levosimendan in amyotrophic lateral sclerosis: a phase II multicentre, randomised, double-blind, placebo-controlled trial." Journal of Neurology, Neurosurgery & Psychiatry 90, no. 10 (July 17, 2019): 1165–70. http://dx.doi.org/10.1136/jnnp-2018-320288.

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ObjectiveTo evaluate the efficacy and safety of oral levosimendan in patients with amyotrophic lateral sclerosis (ALS). This phase II, randomised, double-blind, placebo-controlled, crossover, three-period study with 6 months open-label follow-up enrolled adults with ALS and sitting slow vital capacity (SVC) 60%–90 % of predicted from 11 sites in four countries.MethodsPatients received levosimendan 1 mg daily, 1 mg two times a day or placebo during three 14-day crossover periods and levosimendan 1–2 mg daily during open-label follow-up. Primary endpoint was sitting SVC; secondary endpoints included supine SVC, ALS Functional Rating Scale-Revised (ALSFRS-R), tolerability and safety.ResultsOf 66 patients randomised, 59 contributed to the double-blind results and 50 entered open-label follow-up. Sitting SVC was not significantly different between the treatments. In post hoc analysis using period-wise baselines, supine SVC favoured levosimendan over placebo, estimated mean differences from baseline being −3.62% on placebo, +0.77% on levosimendan 1 mg daily (p=0.018) and +2.38% on 1 mg two times a day (p=0.001). Headache occurred in 16.7% of patients during levosimendan 1 mg daily (p=0.030), 28.6% during 1 mg two times a day (p=0.002) and 3.3% during placebo. The respective frequencies for increased heart rate were 5.1% (p=0.337), 18.5% (p=0.018) and 1.7%. No significant differences between the treatments were seen for other adverse events.ConclusionsLevosimendan did not achieve the primary endpoint of improving sitting SVC in ALS. Headache and increased heart rate were increased on levosimendan, although it was otherwise well tolerated. A phase III study to evaluate the longer term effects of oral levosimendan in ALS is ongoing.

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Veling, Wim, Bart Lestestuiver, Marieke Jongma, H. J. Rogier Hoenders, and Catheleine van Driel. "Virtual Reality Relaxation for Patients With a Psychiatric Disorder: Crossover Randomized Controlled Trial." Journal of Medical Internet Research 23, no. 1 (January 15, 2021): e17233. http://dx.doi.org/10.2196/17233.

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Background Virtual reality (VR) relaxation is a promising mental health intervention that may be an effective tool for stress reduction but has hardly been tested in clinical trials with psychiatric patients. We developed an easy-to-use VR self-management relaxation tool (VRelax) with immersive 360° nature videos and interactive animated elements. Objective To investigate the immediate effects of VR relaxation on negative and positive affective states and short-term effects on perceived stress and symptoms in patients with a psychiatric disorder, compared to standard relaxation exercises. Methods A randomized crossover trial was conducted in 50 patients receiving ambulatory treatment for anxiety, psychotic, depressive, or bipolar disorder. Participants were randomly assigned to start with VRelax or standard relaxation and used both interventions for 10 days at home. They completed 8 visual analog scales of momentary negative and positive affective states before and after each session. Global perceived stress and psychiatric symptoms were measured before and after both intervention periods. Treatment effects were analyzed with multilevel mixed model regression analyses and 2-way analysis of variance. Results Both VRelax and standard relaxation exercises led to a statistically significant immediate improvement of all negative and positive affective states. Compared to standard relaxation, VRelax resulted in a significantly greater reduction of total negative affective state (change 16.2% versus 21.2%; t1684=−2.02, 95% CI −18.70 to −0.28; P=.04). Specifically, VRelax had a stronger beneficial effect on momentary anxiety (t1684=−3.24, 95% CI −6.86 to −1.69), sadness (t1684=−2.32, 95% CI −6.51 to −0.55), and cheerfulness (t1684=2.35, 95% CI 0.51 to 5.75). There were no significant differences between short-term effects of the two treatments on global perceived stress and symptoms. Conclusions If the results of this trial are replicated and extended, VRelax may provide a much-needed, effective, easy-to-use self-management relaxation intervention to enhance psychiatric treatments. Trial Registration Netherlands Trial Register NTR7294; https://www.trialregister.nl/trial/7096

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Estcourt, Claudia S., Oliver Stirrup, Andrew Copas, Nicola Low, Fiona Mapp, John Saunders, Catherine H. Mercer, et al. "Accelerated partner therapy contact tracing for people with chlamydia (LUSTRUM): a crossover cluster-randomised controlled trial." Lancet Public Health 7, no. 10 (October 2022): e853-e865. http://dx.doi.org/10.1016/s2468-2667(22)00204-3.

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Dzator, Jemima S. A., Peter R. C. Howe, Kirsten G. Coupland, and Rachel H. X. Wong. "A Randomised, Double-Blind, Placebo-Controlled Crossover Trial of Resveratrol Supplementation for Prophylaxis of Hormonal Migraine." Nutrients 14, no. 9 (April 22, 2022): 1763. http://dx.doi.org/10.3390/nu14091763.

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Resveratrol, a vasoactive phytoestrogen, has beneficial effects on cerebrovascular function. Previous research has shown that hormonal migraineurs have poorer cerebrovascular function than non-migraineur women. We aimed to investigate if resveratrol supplementation for three months could reduce the hormonal migraine burden index (HMBI: the number of days with menstrual migraine per month), reduce migraine-related disability and improve migraine-related quality of life. A randomised, double-blind, placebo-controlled, crossover, intervention trial was conducted in 62 hormonal migraineurs (mean age: 37.5 ± 0.8 years). Participants consumed 75 mg of resveratrol or matching placebo capsules twice daily for three months before crossing over to the other treatment arm. Participants completed a daily diary and the Headache Impact Test-6™, Migraine Disability Assessment and Migraine-Specific Quality of Life questionnaires at months 0, 3 and 6. The HMBI was the primary outcome and was calculated using data extracted from the participant’s diary. No differences in the HMBI (p = 0.895), the Headache Impact Test-6™, the Migraine Disability Assessment and Migraine-Specific Quality of Life were found between the resveratrol and placebo treatments. Resveratrol supplementation for three months did not affect the HMBI, the migraine-related disability or quality of life measures in our cohort of hormonal migraineurs.

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Sailer, Sebastian, Borja Osona Rodriguez de Torres, José Antonio Gil Sanchez, Catalina Bover Bauzà, Susanne Vetter‐Laracy, and Joan Figuerola Mulet. "Assessment of portable oxygen concentrators in infants undergoing hypoxic challenge testing. A randomised controlled crossover trial." Acta Paediatrica 109, no. 11 (March 18, 2020): 2287–91. http://dx.doi.org/10.1111/apa.15242.

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van den Elsen, Geke AH, Lieke Tobben, Amir IA Ahmed, Robbert Jan Verkes, Cornelis Kramers, Radboud M. Marijnissen, Marcel GM Olde Rikkert, and Marjolein A. van der Marck. "Effects of tetrahydrocannabinol on balance and gait in patients with dementia: A randomised controlled crossover trial." Journal of Psychopharmacology 31, no. 2 (September 27, 2016): 184–91. http://dx.doi.org/10.1177/0269881116665357.

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Lemoncello, Rik, McKay Moore Sohlberg, Steve Fickas, and Jason Prideaux. "A randomised controlled crossover trial evaluating Television Assisted Prompting (TAP) for adults with acquired brain injury." Neuropsychological Rehabilitation 21, no. 6 (December 2011): 825–46. http://dx.doi.org/10.1080/09602011.2011.618661.

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33

Quinnell, Timothy G., Maxine Bennett, Jake Jordan, Abigail L. Clutterbuck-James, Michael G. Davies, Ian E. Smith, Nicholas Oscroft, et al. "A crossover randomised controlled trial of oral mandibular advancement devices for obstructive sleep apnoea-hypopnoea (TOMADO)." Thorax 69, no. 10 (July 17, 2014): 938–45. http://dx.doi.org/10.1136/thoraxjnl-2014-205464.

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34

Serinel, Yasmina, Brendon J. Yee, Ronald R. Grunstein, Keith H. Wong, Peter A. Cistulli, Hisatomi Arima, and Craig L. Phillips. "Chronotherapy for hypertension in obstructive sleep apnoea (CHOSA): a randomised, double-blind, placebo-controlled crossover trial." Thorax 72, no. 6 (December 14, 2016): 550–58. http://dx.doi.org/10.1136/thoraxjnl-2016-209504.

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35

Nicholson, Karl G., Jonathan S. Nguyen-Van-Tam, Ala'eldin H. Ahmed, Martin J. Wiselka, Jane Leese, Jon Ayres, James H. Campbell, et al. "Randomised placebo-controlled crossover trial on effect of inactivated influenza vaccine on pulmonary function in asthma." Lancet 351, no. 9099 (January 1998): 326–31. http://dx.doi.org/10.1016/s0140-6736(97)07468-0.

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36

Spong, J., G. A. Kennedy, J. Tseng, D. J. Brown, S. Armstrong, and D. J. Berlowitz. "Sleep disruption in tetraplegia: a randomised, double-blind, placebo-controlled crossover trial of 3 mg melatonin." Spinal Cord 52, no. 8 (June 3, 2014): 629–34. http://dx.doi.org/10.1038/sc.2014.84.

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37

S, A. D. "Therapeutic electrical stimulation in cerebral palsy: A randomized, controlled, crossover trial." Journal of Developmental & Behavioral Pediatrics 23, no. 2 (April 2002): 123–24. http://dx.doi.org/10.1097/00004703-200204000-00027.

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38

Ney, Denise M., Bridget M. Stroup, Murray K. Clayton, Sangita G. Murali, Gregory M. Rice, Frances Rohr, and Harvey L. Levy. "Glycomacropeptide for nutritional management of phenylketonuria: a randomized, controlled, crossover trial." American Journal of Clinical Nutrition 104, no. 2 (July 13, 2016): 334–45. http://dx.doi.org/10.3945/ajcn.116.135293.

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39

Ferri, C., E. Marzo, G. Longombardo, F. Lombardini, L. La Civita, R. Vanacore, AM Liberati, R. Gerli, F. Greco, and A. Moretti. "Interferon-alpha in mixed cryoglobulinemia patients: a randomized, crossover-controlled trial." Blood 81, no. 5 (March 1, 1993): 1132–36. http://dx.doi.org/10.1182/blood.v81.5.1132.1132.

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Abstract:

Abstract The effects of interferon-alpha (IFN-alpha) on clinical and serologic manifestations of mixed cryoglobulinemia (MC) were investigated by randomized, crossover-controlled trial in 26 patients. The trial alternated 6 months with and 6 months without IFN-alpha therapy (2 x 10(6) IU daily for a month, then every other day for 5 months). In 22 patients, pretreatment steroid dosage remained unchanged during the study. Six patients dropped out (three because of side effects), whereas another 20 patients experienced a significant improvement of purpura (P < .02) and serum transaminases (P < .005) during IFN-alpha treatment. The presence of clinical improvement was supported by the outcome measurements of several immunologic parameters. In particular, serum cryoglobulins were significantly reduced (P < .04) during IFN- alpha therapy. A rebound phenomenon of clinical and serologic parameters was observed after IFN-alpha discontinuation. In addition, no variations were recorded during 6 months without therapy. Hepatitis C virus (HCV) RNA was detected in 91% (20/22) of our MC patients; in 2/13 cases HCV RNA was no longer detectable in serum samples after IFN- alpha therapy. Thus, IFN-alpha could be considered as treatment for MC in patients with HCV seropositivity.

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40

Ferri, C., E. Marzo, G. Longombardo, F. Lombardini, L. La Civita, R. Vanacore, AM Liberati, R. Gerli, F. Greco, and A. Moretti. "Interferon-alpha in mixed cryoglobulinemia patients: a randomized, crossover-controlled trial." Blood 81, no. 5 (March 1, 1993): 1132–36. http://dx.doi.org/10.1182/blood.v81.5.1132.bloodjournal8151132.

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Abstract:

The effects of interferon-alpha (IFN-alpha) on clinical and serologic manifestations of mixed cryoglobulinemia (MC) were investigated by randomized, crossover-controlled trial in 26 patients. The trial alternated 6 months with and 6 months without IFN-alpha therapy (2 x 10(6) IU daily for a month, then every other day for 5 months). In 22 patients, pretreatment steroid dosage remained unchanged during the study. Six patients dropped out (three because of side effects), whereas another 20 patients experienced a significant improvement of purpura (P < .02) and serum transaminases (P < .005) during IFN-alpha treatment. The presence of clinical improvement was supported by the outcome measurements of several immunologic parameters. In particular, serum cryoglobulins were significantly reduced (P < .04) during IFN- alpha therapy. A rebound phenomenon of clinical and serologic parameters was observed after IFN-alpha discontinuation. In addition, no variations were recorded during 6 months without therapy. Hepatitis C virus (HCV) RNA was detected in 91% (20/22) of our MC patients; in 2/13 cases HCV RNA was no longer detectable in serum samples after IFN- alpha therapy. Thus, IFN-alpha could be considered as treatment for MC in patients with HCV seropositivity.

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41

Taylor, Jerome H., Angeli Landeros-Weisenberger, Catherine Coughlin, Jilian Mulqueen, Jessica A. Johnson, Daniel Gabriel, Margot O. Reed, Ewgeni Jakubovski, and Michael H. Bloch. "Ketamine for Social Anxiety Disorder: A Randomized, Placebo-Controlled Crossover Trial." Neuropsychopharmacology 43, no. 2 (August 29, 2017): 325–33. http://dx.doi.org/10.1038/npp.2017.194.

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42

Markman, J. D., M. E. Frazer, S. A. Rast, M. P. McDermott, J. S. Gewandter, A. K. Chowdhry, K. Czerniecka, W. H. Pilcher, L. S. Simon, and R. H. Dworkin. "Double-blind, randomized, controlled, crossover trial of pregabalin for neurogenic claudication." Neurology 84, no. 3 (December 10, 2014): 265–72. http://dx.doi.org/10.1212/wnl.0000000000001168.

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43

Tiihonen, Jari, Tero Hallikainen, Olli-Pekka Ryynänen, Eila Repo-Tiihonen, Irma Kotilainen, Markku Eronen, Päivi Toivonen, Kristian Wahlbeck, and Anu Putkonen. "Lamotrigine in treatment-resistant schizophrenia: a randomized placebo-controlled crossover trial." Biological Psychiatry 54, no. 11 (December 2003): 1241–48. http://dx.doi.org/10.1016/s0006-3223(03)00524-9.

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44

Foo, Ning-Ping, Jer-Hao Chang, Hung-Jung Lin, and How-Ran Guo. "Rescuer fatigue and cardiopulmonary resuscitation positions: A randomized controlled crossover trial." Resuscitation 81, no. 5 (May 2010): 579–84. http://dx.doi.org/10.1016/j.resuscitation.2010.02.006.

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45

Sommerfelt, K., T. Markestad, and K. Berg. "Therapeutic electrical stimulation in cerebral palsy: a randomized, controlled, crossover trial." Developmental Medicine & Child Neurology 43, no. 9 (February 13, 2007): 609–13. http://dx.doi.org/10.1111/j.1469-8749.2001.tb00243.x.

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46

van den Elsen, Geke A. H., Amir I. A. Ahmed, Robbert-Jan Verkes, Ton Feuth, Marjolein A. van der Marck, and Marcel G. M. Olde Rikkert. "Tetrahydrocannabinol in Behavioral Disturbances in Dementia: A Crossover Randomized Controlled Trial." American Journal of Geriatric Psychiatry 23, no. 12 (December 2015): 1214–24. http://dx.doi.org/10.1016/j.jagp.2015.07.011.

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47

Sommerfelt, K., T. Markestad, K. Berg, and I. Sætesdal. "Therapeutic electrical stimulation in cerebral palsy: a randomized, controlled, crossover trial." Developmental Medicine and Child Neurology 43, no. 09 (September 5, 2001): 609. http://dx.doi.org/10.1017/s0012162201001104.

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48

Gil, Maria L. B., Luide M. R. F. Marinho, Márcio de Moraes, Ronaldo S. Wada, Francisco C. Groppo, Jorge E. Sato, and Maria L. R. de Sousa. "Effectiveness of Acupuncture in Dental Surgery: A Randomized, Crossover, Controlled Trial." Journal of Acupuncture and Meridian Studies 13, no. 3 (June 2020): 104–9. http://dx.doi.org/10.1016/j.jams.2020.03.063.

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49

Sørensen, Per Soelberg. "The Effect on MRI of Gammaglobulin Treatment in Relapsing Multiple Sclerosis." Multiple Sclerosis Journal 6, no. 2_suppl (September 2000): S14—S17. http://dx.doi.org/10.1177/135245850000602s04.

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A number of uncontrolled studies and randomised, placebo-controlled trials have shown that treatment with intravenous gammaglobulin (NIG) reduces the exacerbation rate in relapsing multiple sclerosis (MS). Two randomised studies from Denmark and Israel, respectively have used MRI as efficacy endpoint In a Danish crossover trial, the number of gadolinium-enhancing lesions in serial cranial MRI was significantly reduced by approximately 60% during NIG treatment compared to placebo. Neither the Danish study nor an Israeli study were able to show significant reductions in the total lesion load on T2-weighted cranial MRI. However, the studies were either too short or comprised too few patients for showing significant differences in T2-weighted MRI. In conclusion, NIG is of benefit to patients with relapsing MS, but larger studies are required before the place of NIG in the treatment of MS can be established.

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50

Soh, I. P. T. "The dilemma of crossover versus long term results in randomised controlled trials." BMJ 348, apr09 1 (April 9, 2014): g2679. http://dx.doi.org/10.1136/bmj.g2679.

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