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Journal articles on the topic 'Randomized controlled trial/methods'

Author: Grafiati
Published: 4 June 2021
Last updated: 14 February 2022

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1

Willan, Andrew R., and Lehana Thabane. "Bayesian methods for pilot studies." Clinical Trials 17, no. 4 (April 16, 2020): 414–19. http://dx.doi.org/10.1177/1740774520914306.

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Background/aims: The use of pilot studies to help inform the design of randomized controlled trials has increased significantly over the last couple of decades. A pilot study can provide estimates of feasibility parameters, such as the recruitment, compliance and follow-up probabilities. The use of frequentist confidence intervals of these estimates fails to provide a meaningful measure of the uncertainty as it pertains to the design of the associated randomized controlled trial. The objective of this article is to introduce Bayesian methods for the analysis of pilot studies for determining the feasibility of an associated randomized controlled trial. Methods: An example from the literature is used to illustrate the advantages of a Bayesian approach for accounting for the uncertainty in pilot study results when assessing the feasibility of an associated randomized controlled trial. Vague beta distribution priors for the feasibility parameters are used. Based on the results from a feasibility study, simulation methods are used to determine the expected power of specified recruitment strategies for an associated randomized controlled trial. Results: The vague priors used for the feasibility parameters are demonstrated to be considerably robust. Beta distribution posteriors for the feasibility parameters lead to beta-binomial predictive distributions for an associated randomized controlled trial regarding the number of patients randomized, the number of patients who are compliant and the number of patients who complete follow-up. Ignoring the uncertainty in pilot study results can lead to inadequate power for an associated randomized controlled trial. Conclusion: Applying Bayesian methods to pilot studies’ results provides direct inference about the feasibility parameters and quantifies the uncertainty regarding the feasibility of an associated randomized controlled trial in an intuitive and meaningful way. Furthermore, Bayesian methods can identify recruitment strategies that yield the desired power for an associated randomized controlled trial.
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Vautrin, M., G. Kaminski, B. Barimani, J. Elmers, V. Philippe, S. Cherix, E. Thein, O. Borens, and F. Vauclair. "Does candidate for plate fixation selection improve the functional outcome after midshaft clavicle fracture? A systematic review of 1348 patients." Shoulder & Elbow 11, no. 1 (June 4, 2018): 9–16. http://dx.doi.org/10.1177/1758573218777996.

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Introduction The hypothesis of this study was that patient selection for midshaft clavicle fracture (open reduction internal fixation with plate versus conservative) would give better functional outcome than random treatment allocation. Methods We performed a systematic literature search for primary studies providing functional score and non-union rate after conservative or surgical management of midshaft clavicle fractures. Six randomized controlled trial and 19 non-randomized controlled trial studies encompassing a total of 1348 patients were included. Results Patients treated with surgical management were found to have statistically superior Constant scores in non-randomized controlled trials than in randomized controlled trials (94.76 ± 6.4 versus 92.49 ± 6.2; p < 0.0001). For conservative treatment, randomized controlled trials were found to have significantly better functional outcome. The prevalence of non-union (6.1%) did not show significant statistical difference between non-randomized controlled trial and randomized controlled trial studies. The functional outcome after surgical management was significantly higher than after conservative management in both randomized controlled trial and non-randomized controlled trial groups. The non-union rate after surgery (1.1% for both non-randomized controlled trial and randomized controlled trial) was significantly lower than following conservative treatment (9.9% non-randomized controlled trial versus 15.1% randomized controlled trial). Discussion This review shows that patient selection for surgery may influence functional outcome after midshaft clavicle fracture. Our results also confirm that plate fixation provides better functional outcome and lower non-union rate.
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Golden, Isaac. "Beyond Randomized Controlled Trials." Journal of Evidence-Based Complementary & Alternative Medicine 17, no. 1 (January 2012): 72–75. http://dx.doi.org/10.1177/2156587211429351.

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Complementary and alternative medicine is criticized by some as lacking evidence to support the effectiveness of its methods and medicines. Such critics typically point to mixed results from using randomized controlled trials to test complementary and alternative medicine. Randomized controlled trials have been held to be the “gold standard” in pharmaceutical research, but a growing body of evidence in orthodox journals has identified their limitations. Here, 5 fundamental flaws in the randomized controlled trial–based model are discussed as well as the impact on its relevance for testing complementary and alternative medicine therapies. A better way to evaluate complementary and alternative medicine therapies is also proposed. A 7-item checklist is suggested to quantify the strength of an area of complementary and alternative medicine research.
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4

Jackson, Margaret A., Margaret Kellett, Helen V. Worthington, and Valerie Clerehugh. "Comparison of Interdental Cleaning Methods: A Randomized Controlled Trial." Journal of Periodontology 77, no. 8 (August 2006): 1421–29. http://dx.doi.org/10.1902/jop.2006.050360.

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Pascoe, Elaine Mary, Serigne Lo, Anish Scaria, Sunil V. Badve, Elaine Mary Beller, Alan Cass, Carmel Mary Hawley, and David W. Johnson. "The Honeypot Randomized Controlled Trial Statistical Analysis Plan." Peritoneal Dialysis International: Journal of the International Society for Peritoneal Dialysis 33, no. 4 (July 2013): 426–35. http://dx.doi.org/10.3747/pdi.2012.00310.

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BackgroundThe HONEYPOT study is a multicenter, open-label, blinded-outcome, randomized controlled trial designed to determine whether, compared with standard topical application of mupirocin for nasal staphylococcal carriage, exit-site application of antibacterial honey reduces the rate of catheter-associated infections in peritoneal dialysis patients.ObjectiveTo make public the pre-specified statistical analysis principles to be adhered to and the procedures to be performed by statisticians who will analyze the data for the HONEYPOT trial.MethodsStatisticians and clinical investigators who were blinded to treatment allocation and treatment-related study results and who will remain blinded until the central database is locked for final data extraction and analysis determined the statistical methods and procedures to be used for analysis and wrote the statistical analysis plan. The plan describes basic analysis principles, methods for dealing with a range of commonly encountered data analysis issues, and the specific statistical procedures for analyzing the primary, secondary, and safety outcomes.ResultsA statistical analysis plan containing the pre-specified principles, methods, and procedures to be adhered to in the analysis of the data from the HONEYPOT trial was developed in accordance with international guidelines. The structure and content of the plan provide sufficient detail to meet the guidelines on statistical principles for clinical trials produced by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.ConclusionsMaking public the pre-specified statistical analysis plan for the HONEYPOT trial minimizes the potential for bias in the analysis of trial data and the interpretation and reporting of trial results.
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Kessels, Rob, Reagan Mozer, and Jos Bloemers. "Methods for assessing and controlling placebo effects." Statistical Methods in Medical Research 28, no. 4 (December 26, 2017): 1141–56. http://dx.doi.org/10.1177/0962280217748339.

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The placebo serves as an indispensable control in many randomized trials. When analyzing the benefit of a new treatment, researchers are often confronted with large placebo effects that diminish the treatment effect. Various alternative methods have been proposed for analyzing placebo and treatment effects in studies where large placebo effects are expected or have already occurred. This paper presents an overview of methodological work that has been proposed for assessing and/or controlling for placebo effects in randomized trials. Throughout this paper, two main approaches are discussed. The first approach considers designs that represent alternatives to the classical placebo-controlled randomized trial design. Separately, the second approach considers adopting new methods for the statistical analysis of placebo and treatment effects to be implemented after the data have been collected using a classical randomized trial design.
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Gany, Francesca, Jennifer Leng, Ephraim Shapiro, David Abramson, Ivette Motola, David C. Shield, and Jyotsna Changrani. "Patient Satisfaction with Different Interpreting Methods: A Randomized Controlled Trial." Journal of General Internal Medicine 22, S2 (October 24, 2007): 312–18. http://dx.doi.org/10.1007/s11606-007-0360-8.

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Kuroiwa, Erin, Rebecca L. Ragar, Crystal S. Langlais, Angelica Baker, Maria E. Linnaus, and David M. Notrica. "Car seat education: A randomized controlled trial of teaching methods." Injury 49, no. 7 (July 2018): 1272–77. http://dx.doi.org/10.1016/j.injury.2018.05.003.

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Blencowe, Natalie S., Jonathan A. Cook, Thomas Pinkney, Chris Rogers, Barnaby C. Reeves, and Jane M. Blazeby. "Delivering successful randomized controlled trials in surgery: Methods to optimize collaboration and study design." Clinical Trials 14, no. 2 (January 31, 2017): 211–18. http://dx.doi.org/10.1177/1740774516687272.

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Randomized controlled trials in surgery are notoriously difficult to design and conduct due to numerous methodological and cultural challenges. Over the last 5 years, several UK-based surgical trial-related initiatives have been funded to address these issues. These include the development of Surgical Trials Centers and Surgical Specialty Leads (individual surgeons responsible for championing randomized controlled trials in their specialist fields), both funded by the Royal College of Surgeons of England; networks of research-active surgeons in training; and investment in methodological research relating to surgical randomized controlled trials (to address issues such as recruitment, blinding, and the selection and standardization of interventions). This article discusses these initiatives more in detail and provides exemplar cases to illustrate how the methodological challenges have been tackled. The initiatives have surpassed expectations, resulting in a renaissance in surgical research throughout the United Kingdom, such that the number of patients entering surgical randomized controlled trials has doubled.
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ŠAPOKA, Virginijus, Vytautas KASIULEVIČIUS, and Janina DIDŽIAPETRIENĖ. "How should a clinician interpret results of randomized controlled trials?" Acta medica Lituanica 17, no. 1-2 (January 1, 2010): 30–34. http://dx.doi.org/10.15388/amed.2010.21689.

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Randomized controlled trials (RCTs) and systematic reviews are the most reliable methods of determining the effects of treatment. The randomization procedure gives a randomized controlled trial its strength. Random allocation means that all participants have the same chance of being assigned to each of the study groups. The choice of which end point(s) to select is critical to any study design. Intention-to-treat is the preferred approach to the analysis of clinical trials. Sample size calculations and data analyses have an important impact on the planning, interpretation, and conclusions of randomized trials. In this article, we discuss the problematic areas that can affect the outcome of a trial, such as blinding, sample size calculation, randomization; concealment allocation; intention of treating the analysis; selection of end points; selection of traditional versus equivalence testing, early stopped trials, selective publications. Keywords: randomized controlled trials, sample size, outcomes, type of analyses
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Clarke, R. W., M. P. J. Yardley, C. M. Davies, A. Panarese, R. T. Clegg, and A. J. Parker. "Palatoplasty for Snoring: A Randomized Controlled Trial of Three Surgical Methods." Otolaryngology–Head and Neck Surgery 119, no. 3 (September 1998): 288–92. http://dx.doi.org/10.1016/s0194-5998(98)70064-6.

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In a randomized, controlled trial, 62 patients (47 men and 15 women) with severe antisocial snoring, but no sleep apnea, were allocated to one of three surgical treatments. These were uvulopalato-pharyngoplasty, laser palatoplasty, and diathermy palatoplasty. Postoperative morbidity was measured on a visual analogue scale of severity of pain, dysphagia, and nasal regurgitation at 1, 2, and 7 days after the operation. Efficacy of each procedure was measured by asking the sleeping partner to record the severity of snoring before and after the operation, again on a visual analogue scale. Measurements were taken at 1, 3, and 6 months. There were no significant differences in early postoperative morbidity among the treatment groups. Diathermy palatoplasty is a new technique for the relief of snoring that is associated with low morbidity and requires little in the way of expensive equipment.
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Bartman, Thomas, Darren A. DeWalt, David P. Johnson, David R. Mehr, Asha S. Payne, and Lloyd P. Provost. "Improvement Science Takes Advantage of Methods beyond the Randomized Controlled Trial." Pediatric Quality and Safety 3, no. 3 (2018): e082. http://dx.doi.org/10.1097/pq9.0000000000000082.

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Chen, Xingshi, Runsen Jin, Jie Xiang, Dingpei Han, Yajie Zhang, Chengqiang Li, Su Yang, et al. "Methods for Dissecting Intersegmental Planes in Segmentectomy: A Randomized Controlled Trial." Annals of Thoracic Surgery 110, no. 1 (July 2020): 258–64. http://dx.doi.org/10.1016/j.athoracsur.2020.02.013.

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Pham, Quynh, David Wiljer, and Joseph A. Cafazzo. "Beyond the Randomized Controlled Trial: A Review of Alternatives in mHealth Clinical Trial Methods." JMIR mHealth and uHealth 4, no. 3 (September 9, 2016): e107. http://dx.doi.org/10.2196/mhealth.5720.

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Elrggal, Mahmood E., Morooj Al-Muwallad, Areej Al-Otaibi, Jomanah Alsiddik, Alaa Shahbar, and Ejaz Cheema. "Assessment of quality of reporting of Helicobacter pylori related randomized controlled trials: a focus on highly ranked gastroenterology journals." International Journal of Clinical Trials 5, no. 1 (January 23, 2018): 21. http://dx.doi.org/10.18203/2349-3259.ijct20180127.

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<p class="abstract"><strong>Background:</strong> Randomized controlled trials are often considered as the gold standard for measuring the effectiveness of an intervention. However, inappropriate or poor reporting in randomized controlled trials can produce biased estimates of treatment effects.<strong> </strong>Clinical trials that do not use the CONSORT statement for reporting their findings will have limited value to the clinicians and researchers due to the risk of bias in their results. This review aims to assess the quality of reporting of randomized controlled trials in <em>Helicobacter pylori</em> associated infections by using the CONSORT 2010 checklist.</p><p class="abstract"><strong>Methods:</strong> All issues of 20 highly ranked gastroenterology journals published from Jan 2011 up to November 2017 were searched. Searches were conducted in November 2017. Randomized controlled trials reporting on <em>Helicobacter pylori</em> associated infections were included in the review.</p><p class="abstract"><strong>Results:</strong> 21 randomized controlled trials published in gastroenterology journals were included in the study. All included studies adequately reported (100%) on items including description of interventions, outcomes assessed, total number of participants analysed, baseline characteristics and results of outcome assessed. However, items including blinding and mechanism of allocation concealment were reported in only 12 randomized controlled trials (50%).<strong> </strong>The maximum and minimum scores and percentage of compliance of included randomised controlled trials were 24 (100%) and 15 (62.5%) respectively.</p><p><strong>Conclusions: </strong>The finding of this review suggests that the overall quality of reporting in the included randomized controlled trials was adequate. However, items including trial design, trial registration and protocol and sample size calculations should be reported adequately in the future randomized controlled trials to improve the quality of reporting and replicability of clinical trials.</p>
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Badian, Reza A., Brendan McCormack, and Vibeke Sundling. "Person-Centered Research: A novel approach to Randomized Controlled Trials." European Journal for Person Centered Healthcare 6, no. 2 (June 1, 2018): 209. http://dx.doi.org/10.5750/ejpch.v6i2.1435.

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Introduction: Integrating person-centered values with randomized controlled trials methodology is a novel idea. Person-centeredness is gaining steadily more prominence and attention in healthcare and health-related policy and research. Randomized controlled trials are considered as the gold standard in evidence-based medicine for evaluating the effects of treatment or determining the causal effect. A wide array of study designs is available, but there is a lack of designs with both strong person-centered principles and a strong position with respect to the level of evidence. In this paper we intend to introduce a novel design to fill such a gap.Aims and objectives: The aim of this paper is to introduce a novel study design where essential values of person-centered care (PCC) are integrated with randomized controlled trial (RCT) methodology into a novel study design termed a person-centered randomized controlled trial (PC-RCT).Methods: In this paper we discuss the importance and role of evidence in clinical research, levels of evidence, as well as the significance of study design in evidence-based medicine. Moreover, we discuss randomized controlled trials that are considered the gold standard to achieve high quality evidence. In this paper we will explain what the concept of person-centered care is and discuss the values associated with person-centeredness.The theoretical and methodological considerations that are relevant in applying this concept will be discussed before presenting how we intend to incorporate person-centered values into a randomized controlled trial in a novel study design that is both person-centered and randomized controlled (PC-RCT). Different aspects of this proposed novel study design will be discussed, including the theory and methods underlying this new proposed design, its novelty, different stages and practical steps involved in this proposed design. Challenges, drawbacks and possible solutions for addressing challenges of this novel design will be explored, focusing on the construct, dynamics, advantages, disadvantages and novelty of PC-RCT design.Conclusion: This paper presents how person-centered values and traditional randomised controlled trial principal values are integrated into one study design where the strengths of both concepts are merged into one. The proposed novel study design has stronger person-centered characteristics and is solid in its RCT features. This design ensures that participants have much more active participation in decision-making and gain more choice in their treatment. The proposed novel study design in this paper has clearly an important role to play in satisfying the need for a study design that can address both the need for rendering higher levels of evidence as well as simultaneously securing greater integration of person-centered values in the same study design.
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Alromaih, Saud, Ibrahim Sumaily, Ibrahim Alarifi, Ahmad Alroqi, Mohammad Aloulah, Abdulrazag Ajlan, Faris Yaghmoor, and Saad Alsaleh. "Seeker Uncinectomy: A Randomized Controlled Cadaveric Trial." Allergy & Rhinology 11 (January 2020): 215265672097126. http://dx.doi.org/10.1177/2152656720971262.

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Background Endoscopic sinus surgery is a common surgery, in which the uncinate process of the ethmoid is removed as the first surgical step. There are multiple techniques for uncinectomy. Herein we describe a new and simple uncinectomy technique. Methods We performed a randomised controlled trial with blinded assessors. Eight cadaveric heads were used to compare the new technique to the commonly used technique; retrograde uncinectomy. The procedures were performed by 2 rhinologists, and the findings were evaluated by 2 senior rhinologists blinded to the technique and the surgeon who did. They assessed the final view of the procedure and the complications. Thereafter, they assessed the procedure for the duration and ease of each technique for teaching purposes. Results Fifteen uncinectomies were performed, 7 using the retrograde technique, and 8 using the new technique. The mean durations were 5.64 min using the seeker uncinectomy and 7.57 min using the retrograde uncinectomy, p-value = 0.017. The completion was better in seeker uncinectomy; however, not significant statistically, p > 0.05. The complications with the new technique were inferior turbinate injury in 12.5% and natural ostium non-identification in 12.5%, p > 0.05. With retrograde uncinectomy, lacrimal injury occurred in 14.3%, p > 0.05. The ease of teaching scores was higher for the seeker uncinectomy. Conclusion Based on this cadaveric trial, seeker uncinectomy seems to be a safe and easy to perform technique. However, injury to the inferior turbinate and missing the natural ostium must be taken into consideration. These warrant further studies on the clinical application of this procedure.
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Merry, Alan F., Jacqueline A. Hannam, Craig S. Webster, Kylie-Ellen Edwards, Jane Torrie, Chris Frampton, Daniel W. Wheeler, et al. "Retesting the Hypothesis of a Clinical Randomized Controlled Trial in a Simulation Environment to Validate Anesthesia Simulation in Error Research (the VASER Study)." Anesthesiology 126, no. 3 (March 1, 2017): 472–81. http://dx.doi.org/10.1097/aln.0000000000001514.

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Abstract Background Simulation has been used to investigate clinical questions in anesthesia, surgery, and related disciplines, but there are few data demonstrating that results apply to clinical settings. We asked “would results of a simulation-based study justify the same principal conclusions as those of a larger clinical study?” Methods We compared results from a randomized controlled trial in a simulated environment involving 80 cases at three centers with those from a randomized controlled trial in a clinical environment involving 1,075 cases. In both studies, we compared conventional methods of anesthetic management with the use of a multimodal system (SAFERsleep®; Safer Sleep LLC, Nashville, Tennessee) designed to reduce drug administration errors. Forty anesthesiologists each managed two simulated scenarios randomized to conventional methods or the new system. We compared the rate of error in drug administration or recording for the new system versus conventional methods in this simulated randomized controlled trial with that in the clinical randomized controlled trial (primary endpoint). Six experts were asked to indicate a clinically relevant effect size. Results In this simulated randomized controlled trial, mean (95% CI) rates of error per 100 administrations for the new system versus conventional groups were 6.0 (3.8 to 8.3) versus 11.6 (9.3 to 13.8; P = 0.001) compared with 9.1 (6.9 to 11.4) versus 11.6 (9.3 to 13.9) in the clinical randomized controlled trial (P = 0.045). A 10 to 30% change was considered clinically relevant. The mean (95% CI) difference in effect size was 27.0% (−7.6 to 61.6%). Conclusions The results of our simulated randomized controlled trial justified the same primary conclusion as those of our larger clinical randomized controlled trial, but not a finding of equivalence in effect size.
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Murray, David M., Monica Taljaard, Elizabeth L. Turner, and Stephanie M. George. "Essential Ingredients and Innovations in the Design and Analysis of Group-Randomized Trials." Annual Review of Public Health 41, no. 1 (April 2, 2020): 1–19. http://dx.doi.org/10.1146/annurev-publhealth-040119-094027.

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This article reviews the essential ingredients and innovations in the design and analysis of group-randomized trials. The methods literature for these trials has grown steadily since they were introduced to the biomedical research community in the late 1970s, and we summarize those developments. We review, in addition to the group-randomized trial, methods for two closely related designs, the individually randomized group treatment trial and the stepped-wedge group-randomized trial. After describing the essential ingredients for these designs, we review the most important developments in the evolution of their methods using a new bibliometric tool developed at the National Institutes of Health. We then discuss the questions to be considered when selecting from among these designs or selecting the traditional randomized controlled trial. We close with a review of current methods for the analysis of data from these designs, a case study to illustrate each design, and a brief summary.
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Hofauer, Benedikt, Ulrich Straßen, Adam Chaker, Beate Schossow, Magdalena Wirth, Markus Wirth, Murat Bas, and Andreas Knopf. "Liposomal Inhalation after Tracheostomy—A Randomized Controlled Trial." Journal of Clinical Medicine 10, no. 15 (July 27, 2021): 3312. http://dx.doi.org/10.3390/jcm10153312.

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Background: Tracheostomy is a common procedure in critical care. The aim of this study was to evaluate the application of a liposomal inhalation compared to standard physiologic saline (SPS) inhalation on basis of objective and subjective parameters of airway inflammation. Methods: We evaluated in this two-armed, double-blinded and randomized control group study the effect of liposomal compared with SPS inhalation in newly tracheotomized patients. The primary endpoint was defined as trend of tracheobronchial IL-6 secretion at day 1 compared to day 10. Further objective and subjective parameter were evaluated. Results: Fifty patients were randomized in each arm. Tracheal IL-6 levels decreased significantly only after liposomal inhalation. Both inhalative agents seem to have an effect on the respiratory impairment after tracheostomy. Subjective patient impairment was reduced significantly from day 1 to day 10 after tracheostomy with liposomal inhalation. Conclusions: Liposomal inhalation demonstrated an advantage over SPS inhalation in newly tracheotomized patients.
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Ay, Saime, Deniz Evcik, and Birkan Sonel Tur. "Comparison of injection methods in myofascial pain syndrome: a randomized controlled trial." Clinical Rheumatology 29, no. 1 (October 20, 2009): 19–23. http://dx.doi.org/10.1007/s10067-009-1307-8.

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Edman Tynelius, Gudrun, Sofia Petrén, Lars Bondemark, and Eva Lilja-Karlander. "Five-year postretention outcomes of three retention methods—a randomized controlled trial." European Journal of Orthodontics 37, no. 4 (December 1, 2014): 345–53. http://dx.doi.org/10.1093/ejo/cju063.

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Leszczyński, Piotr, Joanna Gotlib, Zbigniew Kopański, Arkadiusz Wejnarski, Stanisław Świeżewski, and Robert Gałązkowski. "Analysis of Web-based learning methods in emergency medicine: randomized controlled trial." Archives of Medical Science 14, no. 3 (2018): 687–94. http://dx.doi.org/10.5114/aoms.2015.56422.

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Fortier, Michelle S., William Hogg, Tracey L. O’Sullivan, Christopher Blanchard, Robert D. Reid, Ronald J. Sigal, Pierre Boulay, et al. "The physical activity counselling (PAC) randomized controlled trial: rationale, methods, and interventions." Applied Physiology, Nutrition, and Metabolism 32, no. 6 (December 2007): 1170–85. http://dx.doi.org/10.1139/h07-075.

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Primary care is a promising venue to build patient motivation and confidence to increase physical activity (PA). Physician PA counselling has demonstrated some success; however, maintenance of behaviour change appears to require more intensive interventions. In reality, most physicians do not have the necessary training nor the time for this type of counselling. The purpose of this paper is to outline the rationale, methods, and interventions for the ongoing physical activity counselling (PAC) randomized controlled trial (RCT), which aims to assess the impact of integrating a PA counsellor into a primary care practice. This RCT has 2 arms: (i) brief PA counselling (2–4 min) from a health care provider and (ii) brief PA counselling + intensive PA counselling from a PA counsellor (3 months). The impact of this intervention is being evaluated using the comprehensive RE-AIM framework. One hundred twenty insufficiently active adult patients, aged 18 to 69 y and recruited during regular primary care visits have been randomized. Dependent measures include psychological mediators, PA participation, quality of life, and physical and metabolic outcomes. The PAC project represents an innovative, theoretically-based approach to promoting PA in primary care, focusing on psychological mediators of change. We anticipate that key lessons from this study will be useful for shaping future public health interventions, theories, and research.
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Ahlqvist, Jan B., Tore A. Nilsson, Leif R. Hedman, Terry S. Desser, Parvati Dev, Magnus Johansson, Patricia L. Youngblood, Robert P. Cheng, and Garry E. Gold. "A Randomized Controlled Trial on 2 Simulation-Based Training Methods in Radiology." Simulation in Healthcare: The Journal of the Society for Simulation in Healthcare 8, no. 6 (December 2013): 382–87. http://dx.doi.org/10.1097/sih.0b013e3182a60a48.

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Hodorowicz, Mary T., Richard Barth, Theresa Moyers, and Frederick Strieder. "A Randomized Controlled Trial of Two Methods to Improve Motivational Interviewing Training." Research on Social Work Practice 30, no. 4 (November 22, 2019): 382–91. http://dx.doi.org/10.1177/1049731519887438.

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Purpose: This randomized controlled study examines the efficacy of two innovative methods to teach beginning motivational interviewing (MI) skills: live supervision (LS), a small group experiential learning interaction with standardized client actors and in-the-moment guidance from a supervisor, and a coding learning (CL) method, where students in a classroom setting are introduced to MI skill development via learning to code MI practice behaviors. Methods: Seventeen social work students in a child welfare training program were randomized to receive either LS or CL training method. Changes in MI knowledge, attitudes, and MI skill were assessed through self-report and observational measures pretraining, posttraining, and at 5 months follow-up, after a semester of learning-as-usual. Results: Both training groups demonstrated an improvement in MI knowledge and attitudes from pretest to follow-up. MI skill gain within groups varied for specific MI skills. Discussion: Implications for maximally efficient MI training are advanced.
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Hinshaw, Kim, Gasser El-Bishry, Sarah Davison, Anthony John Hildreth, and Ann Cooper. "Randomized Controlled Trial Comparing Three Methods of Presenting Risk of Downʼs Syndrome." Obstetrical & Gynecological Survey 62, no. 12 (December 2007): 767–68. http://dx.doi.org/10.1097/01.ogx.0000291201.69278.d15.

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Hanyong, Sun, Lau Wanyee, Fu Siyuan, Liu Hui, Yang Yuan, Lin Chuan, Zhou Weiping, and Wu Mengchao. "A prospective randomized controlled trial: Comparison of two different methods of hepatectomy." European Journal of Surgical Oncology (EJSO) 41, no. 2 (February 2015): 243–48. http://dx.doi.org/10.1016/j.ejso.2014.10.057.

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Jiang, Zi Yang, Zhen Huang, Isaac Schmale, Eric L. Brown, Michael C. Lorenz, Scott J. Patlovich, Karan Goswami, et al. "N95 respirator reuse, decontamination methods, and microbial burden: A randomized controlled trial." American Journal of Otolaryngology 42, no. 5 (September 2021): 103017. http://dx.doi.org/10.1016/j.amjoto.2021.103017.

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McPeek, Bucknam, Frederick Mosteller, and Martin McKneally. "Randomized Clinical Trials in Surgery." International Journal of Technology Assessment in Health Care 5, no. 3 (July 1989): 317–32. http://dx.doi.org/10.1017/s026646230000739x.

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When it is well conducted, a randomized clinical provides the strongest evidence available for evaluating the comparative effectiveness of the interventions tested. Over the last two generations, we have learned much about various devices for strengthening them and about methods of avoiding between in their design, execution, analysis, and reporting. In a trial, we seek evidence for a causal link between treatment and observed outcomes. Becaues the controlled trial depends on an argument based on exculsion (i.e., no other causes or differences affected the experimental groups), we strengthen its inference by taking steps to exclude any such differences.This article discusses a number of issues that deserve consideration: problems of multiplicity and generalizability, devices for strengthening trials, issues of power and sample size, the relationship between study design and reported gains, when to undertake a trial, the role of collaborative trials, and ways to make trials more feasible in clinical settings.
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Weir, Arielle, Justin Presseau, Simon Kitto, Ian Colman, and Simon Hatcher. "Strategies for facilitating the delivery of cluster randomized trials in hospitals: A study informed by the CFIR-ERIC matching tool." Clinical Trials 18, no. 4 (April 16, 2021): 398–407. http://dx.doi.org/10.1177/17407745211001504.

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Background Recruitment and engagement of clusters in a cluster randomized controlled trial can sometimes prove challenging. Identification of successful or unsuccessful strategies may be beneficial in guiding future researchers in conducting their cluster randomized controlled trial. This study aimed to identify strategies that could be used to facilitate the delivery of cluster randomized controlled trials in hospitals. Methods The study employed the Consolidated Framework for Implementation Research–Expert Recommendations for Implementing Change matching tool. The barriers and enablers to cluster randomized controlled trial conduct identified in our previously conducted studies served as a means of determinant identification for the conduct of cluster randomized controlled trials. These determinants were mapped to Consolidated Framework for Implementation Research constructs and then matched to Expert Recommendations for Implementing Change compilation strategies using the Consolidated Framework for Implementation Research–Expert Recommendations for Implementing Change matching tool. Results The Expert Recommendations for Implementing Change strategies matched to at least one determinant Consolidated Framework for Implementation Research construct were as follows: (1) ‘Identify and prepare champions’, (2) ‘Conduct local needs assessment’, (3) ‘Conduct educational meetings’, (4) ‘Inform local opinion leaders’, (5) ‘Build a coalition’, (6) ‘Promote adaptability’, (7) ‘Develop a formal implementation blueprint’, (8) ‘Involve patients/consumers and family members’, (9) ‘Obtain and use patients/consumers and family feedback’, (10) ‘Develop educational materials’, (11) ‘Promote network weaving’, (12) ‘Distribute educational materials’, (13) ‘Access new funding’ and (14) ‘Develop academic partnerships’. Conclusion This study was intended as a step in the research agenda aimed at facilitating cluster randomized controlled trial delivery in hospitals and can act as a resource for future researchers when planning their cluster randomized controlled trial, with the expectation that the strategies identified here will be tailored to each context.
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Horiguchi, Miki, Michael J. Hassett, and Hajime Uno. "Empirical power comparison of statistical tests in contemporary phase III randomized controlled trials with time-to-event outcomes in oncology." Clinical Trials 17, no. 6 (September 15, 2020): 597–606. http://dx.doi.org/10.1177/1740774520940256.

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Background: More than 95% of recent cancer randomized controlled trials used the log-rank test to detect a treatment difference making it the predominant tool for comparing two survival functions. As with other tests, the log-rank test has both advantages and disadvantages. One advantage is that it offers the highest power against proportional hazards differences, which may be a major reason why alternative methods have rarely been employed in practice. The performance of statistical tests has traditionally been investigated both theoretically and numerically for several patterns of difference between two survival functions. However, to the best of our knowledge, there has been no attempt to compare the performance of various statistical tests using empirical data from past oncology randomized controlled trials. So, it is unknown whether the log-rank test offers a meaningful power advantage over alternative testing methods in contemporary cancer randomized controlled trials. Focusing on recently reported phase III cancer randomized controlled trials, we assessed whether the log-rank test gave meaningfully greater power when compared with five alternative testing methods: generalized Wilcoxon, test based on maximum of test statistics from multiple weighted log-rank tests, difference in t-year event rate, and difference in restricted mean survival time with fixed and adaptive [Formula: see text]. Methods: Using manuscripts from cancer randomized controlled trials recently published in high-tier clinical journals, we reconstructed patient-level data for overall survival (69 trials) and progression-free survival (54 trials). For each trial endpoint, we estimated the empirical power of each test. Empirical power was measured as the proportion of trials for which a test would have identified a significant result ( p value < .05). Results: For overall survival, t-year event rate offered the lowest (30.4%) empirical power and restricted mean survival time with fixed [Formula: see text] offered the highest (43.5%). The empirical power of the other types of tests was almost identical (36.2%–37.7%). For progression-free survival, the tests we investigated offered numerically equivalent empirical power (55.6%–61.1%). No single test consistently outperformed any other test. Conclusion: The empirical power assessment with the past cancer randomized controlled trials provided new insights on the performance of statistical tests. Although the log-rank test has been used in almost all trials, our study suggests that the log-rank test is not the only option from an empirical power perspective. Near universal use of the log-rank test is not supported by a meaningful difference in empirical power. Clinical trial investigators could consider alternative methods, beyond the log-rank test, for their primary analysis when designing a cancer randomized controlled trial. Factors other than power (e.g. interpretability of the estimated treatment effect) should garner greater consideration when selecting statistical tests for cancer randomized controlled trials.
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Chirkova, Anastasiya, Alexander Petrenko, and Pavel Vasilyev. "Testing Meldonium: Assessing Soviet pragmatic alternatives to the randomized controlled trial." Clinical Trials 18, no. 3 (April 22, 2021): 269–76. http://dx.doi.org/10.1177/17407745211008540.

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Background/aims Current research largely tends to ignore the drug-testing model that was developed in the “Second World” as an explicit alternative to the randomized controlled trial. This system can be described as “socialist pharmapolitics,” accounting for the specific features of state socialism that influenced the development and testing of experimental drugs. The clinical trials model employed in the “Second World” was heavily influenced by the Soviet Union, which was by far the most influential player in the socialist bloc during the Cold War. Based on extensive archival research, this article presents an empirical case of a late Soviet clinical trial as a pragmatic alternative to the randomized controlled trial model. It accounts for the divergences between the official model prescribed by the Soviet authorities and the messy realities of healthcare practice. It further outlines different factors that ultimately shaped how clinical trials were organized in Soviet institutions “on the ground.” Accordingly, this article presents a “real-life” history of “socialist pharmapolitics” and outlines the problems that this system faced in practice. Methods Archival research was conducted at the Russian State Archive of Scientific and Technical Documentation in Moscow. Archival files include scientific, technical, and registration documentation such as biochemical, pharmacological, and clinical descriptions of the experimental drug Meldonium, letters between various hospitals, research institutes and the Soviet regulatory body, as well as 26 reports of completed clinical trials. Manual content analysis was used for the interpretation of results. Results This article presents an empirical case of a late Soviet clinical trial as a pragmatic alternative to the randomized controlled trial model. It demonstrates some key differences from the randomized controlled trial model. This article also highlights some of the discrepancies between the model that was officially prescribed by the Soviet authorities and the realities of experimental drug testing in the Soviet Union in the late 1980s and early 1990s. In particular, it notes some elements of randomization, double-blinding, and the use of placebo that were present in Meldonium trials despite being formally denounced by Soviet bioethics. Conclusion The Soviet model for testing experimental drugs differed from the Western one substantially in a number of respects. This difference was not only proclaimed officially by the Soviet authorities, but was for the most part enforced in clinical trials in practice. At the same time, our research demonstrates that there were important differences between the official model and the clinical realities on the ground.
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Mansour, Ahmed. "Neonatal outcomes in case of euglycemic control in gestational diabetes using insulin versus metformin. Randomized controlled trial." Journal of Clinical Research and Reports 7, no. 1 (February 24, 2021): 01–08. http://dx.doi.org/10.31579/2642-9756/045.

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Background: Gestational diabetes mellitus (GDM) is a major global public health issue, with prevalence increasing in recent years due to the epidemic of obesity and type 2 diabetes. Aim of the Work: to compare different neonatal outcomes according to the different treatment modalities used in the management of GDM. Our hypothesis was that Metformin is as effective and safe as insulin in patients with gestational diabetes. Patients and Methods: The current non inferiority-Randomized controlled trial was conducted at Ain Shams Maternity hospital between June 2020 to February 2021. The study included 140 outpatient cases or admitted patients for antenatal care: Group A: women were given Metformin (Total 70) and Group B: Women were given insulin. (Total 70). Results: there was no significant difference between Metformin and Insulin groups regarding age, enrollment BMI, parity and family history of DM. There was no significant difference between Metformin and Insulin groups regarding gestational age at enrollment and delivery as well as pregnancy duration after intervention. BMI at delivery, BMI increase as well as BMI increase rate were significantly lower in Metformin group. There were no significant differences between Metformin and Insulin groups regarding fasting, two-hour postprandial and HbA1c blood glucose at enrollment and throughout treatment as well as their reduction after intervention. Maternal complications as hypoglycemia, hyperglycemia and preeclampsia were non-significantly less frequent among Metformin group than among Insulin group. Compliance to treatment was significantly more frequent among Metformin group than among Insulin group. Cesarean delivery was non­significantly less frequent among Metformin group than among Insulin group. There was no significant difference between Metformin and Insulin regarding birth weight APGAR-1, but APGAR-5 was significantly higher in Metformin group. Neonatal complications as IUFD, IUGR, macrosomia, congenital anomalies, neonatal hypoglycemia, respiratory distress and NICU admission were non-significantly less frequent among Metformin group. Conclusions: From the results of current study we can conclude that: Oral metformin was effective as insulin injection in control and management of GDM. BMI was controlled with oral metformin better than insulin injection. Maternal and neonatal complications specially birth weight were the same with both types of treatment. Women had better compliance to metformin treatment. Type of delivery wasn’t affected by type of treatment.
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Kennedy, ED, JE Blair, R. Ready, BG Wolff, AH Steinhart, PW Carryer, and RS McLeod. "Patients’ Perceptions of their Participation in a Clinical Trial for Postoperative Crohn’s Disease." Canadian Journal of Gastroenterology 12, no. 4 (1998): 287–91. http://dx.doi.org/10.1155/1998/274172.

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OBJECTIVE: To explore patients' perceptions of their participation in a randomized controlled trial.PATIENTS AND METHODS: A 27-item questionnaire was mailed to all patients who participated in a randomized controlled trial that determined the effectiveness of mesalamine in preventing the recurrence of Crohn's disease postoperatively.RESULTS: The response rate was 66% (99 of 149). Fifty-five per cent of the patients felt that they received better medical care than they otherwise would have and 53% liked taking the medication. Sixty-eight per cent of the patients did not feel that annual colonoscopy was too frequent and 81% felt that the time commitment did not significantly interfere with their job or other activities. Seventy-five per cent and 62% of the patients would have liked more information and education, respectively, about Crohn's disease incorporated into the trial. Although 91% of the patients would agree to participate in a future randomized controlled trial comparing medical therapies, only 44% would agree to participate in a future randomized controlled trial comparing medical with surgical therapies.CONCLUSIONS: The majority of patients were satisfied with their participation in the trial. A large proportion of the patients would participate again but would like more information and education incorporated into the trial. Furthermore, post-trial questionnaires may be helpful in the design of future trials.
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Machado, Eduardo, Lívia Zuchetto dos Santos, Lilian Gonçalves Custódio, and Paulo Afonso Cunali. "Botulinum toxin for treating muscular temporomandibular disorders: a systematic review." Dental Press Journal of Orthodontics 17, no. 6 (December 2012): 167–71. http://dx.doi.org/10.1590/s2176-94512012000600029.

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OBJECTIVE: This study, through a systematic literature review, aims to analyze the effectiveness of Botulinum Toxin as a treatment for masticatory myofascial pain and muscles temporomandibular disorders (TMD). METHODS: Survey in research bases: MEDLINE, Cochrane, EMBASE, Pubmed, Lilacs and BBO, between the years of 1966 and April 2011, with focus in randomized or quasi-randomized controlled clinical trials, blind or double-blind. RESULTS: After applying the inclusion criteria, 4 articles comprised the final sample: 3 were double-blind randomized controlled clinical trials and 1 was single-blind randomized controlled clinical trial. CONCLUSIONS: According to the literature, there is lack of evidence about the real effectiveness of botulinum toxin in the treatment of masticatory myofascial pain and muscular TMD. Thus, further randomized controlled clinical trials, with representative samples and longer follow-up time, to assess the real effectiveness of the technique are needed.
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Mannell, Jenevieve, Katy Davis, Kohenour Akter, Hannah Jennings, Joanna Morrison, Abul Kuddus, and Edward Fottrell. "Visual Participatory Analysis: A Qualitative Method for Engaging Participants in Interpreting the Results of Randomized Controlled Trials of Health Interventions." Journal of Mixed Methods Research 15, no. 1 (April 13, 2020): 18–36. http://dx.doi.org/10.1177/1558689820914806.

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This article contributes to the field of mixed methods by introducing a new method for eliciting participant perspectives of the quantitative results of randomized controlled trials. Participants are rarely asked to interpret trial results, obscuring potentially valuable information about why a trial either succeeds or fails. We introduce a unique method called visual participatory analysis and discuss the insights gained in its use as part of a trial to prevent risk and reduce the prevalence of diabetes in Bangladesh. Findings highlight benefits such as elucidating contextualized explanations for null results and identifying causal mechanisms, as well as challenges around communicating randomized controlled trial methodologies to lay audiences. We conclude that visual participatory analysis is a valuable method to use after a trial.
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Ohsumi, Shozo, Hirofumi Mukai, Masato Takahashi, Yasuo Hozumi, Hiromitsu Akabane, Youngjin Park, Eriko Tokunaga, et al. "Factors affecting enrollment in randomized controlled trials conducted for patients with metastatic breast cancer." Japanese Journal of Clinical Oncology 50, no. 8 (May 28, 2020): 873–81. http://dx.doi.org/10.1093/jjco/hyaa065.

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Abstract Background It is critical to obtain informed consent from eligible patients to complete clinical trials. We investigated the factors that affect the participation rates of eligible patients. Patients and methods Patients with metastatic breast cancer who were eligible for SELECT BC or SELECT BC-CONFIRM trials, randomized controlled trials conducted for patients with chemotherapy-naive metastatic breast cancer were recruited to prospective studies, SELECT BC-FEEL and SELECT BC-FEEL II, respectively. SELECT BC FEEL and SELECT BC-FEEL II were conducted to identify the factors affecting the rates at which informed consent was obtained, using a self-administered questionnaire we developed. Results In total, 232 patients participated in the studies. The patients who agreed to take part in the randomized trials were more likely than the refusers to answer that they decided to participate because: ‘My doctor wanted me to participate in this trial’ (P = 0.00000), ‘ My family or friends wanted me to participate in this trial’ (P = 0.00000), ‘Both treatment regimens used in the trial are suitable to me’ (P = 0.00383), ‘I know that the trial is conducted to determine which is a better treatment’ (P = 0.01196), and ‘ I think that my participation in the trial will contribute to the benefit to future patients with the same disease’ (P = 0.00756). Conclusions To enhance the consent rate in randomized trials of metastatic breast cancer patients, concepts of the trials must be considered important and acceptable not only by patients but also by doctors and their families.
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Bates, J., R. Dwyer, L. O'Toole, L. Kevin, N. O'Hegarty, and P. Logan. "Corneal protection in critically ill patients: a randomized controlled trial of three methods." Clinical Intensive Care 15, no. 1 (March 2004): 23–26. http://dx.doi.org/10.3109/09563070410001661759.

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White, Peter, Felicity L. Bishop, Phil Prescott, Clare Scott, Paul Little, and George Lewith. "Practice, practitioner, or placebo? A multifactorial, mixed-methods randomized controlled trial of acupuncture." Pain 153, no. 2 (February 2012): 455–62. http://dx.doi.org/10.1016/j.pain.2011.11.007.

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Morris, Sarah H., Hilary E. Kratz, Diana Antinoro Burke, Hana F. Zickgraf, Catherine Coogan, Doug Woods, and Martin E. Franklin. "Behavior therapy for pediatric trichotillomania: Rationale and methods for a randomized controlled trial." Journal of Obsessive-Compulsive and Related Disorders 9 (April 2016): 116–24. http://dx.doi.org/10.1016/j.jocrd.2016.04.004.

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Koenen, Michael, Megan Passey, and Margaret Rolfe. "“Keeping Them Warm”—A Randomized Controlled Trial of Two Passive Perioperative Warming Methods." Journal of PeriAnesthesia Nursing 32, no. 3 (June 2017): 188–98. http://dx.doi.org/10.1016/j.jopan.2015.09.011.

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Bates, J., R. Dwyer, L. O'Toole, L. Kevin, N. O'Hegarty, and P. Logan. "Corneal protection in critically ill patients: a randomized controlled trial of three methods." Clinical Intensive Care 15, no. 1 (March 1, 2004): 23–26. http://dx.doi.org/10.1080/09563070410001661759.

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Bialka, Szymon, Maja Copik, Andrzej Daszkiewicz, Eva Rivas, Kurt Ruetzler, Lukasz Szarpak, and Hanna Misiolek. "Comparison of different methods of postoperative analgesia after thoracotomy—a randomized controlled trial." Journal of Thoracic Disease 10, no. 8 (August 2018): 4874–82. http://dx.doi.org/10.21037/jtd.2018.07.88.

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Boudreaux, Edwin D., Barbara Stanley, Kelly L. Green, Hanga Galfalvy, and Gregory K. Brown. "A randomized, controlled trial of the safety planning intervention: Research design and methods." Contemporary Clinical Trials 103 (April 2021): 106291. http://dx.doi.org/10.1016/j.cct.2021.106291.

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Autier, Philippe, Clarisse Héry, Jari Haukka, Mathieu Boniol, and Graham Byrnes. "Advanced Breast Cancer and Breast Cancer Mortality in Randomized Controlled Trials on Mammography Screening." Journal of Clinical Oncology 27, no. 35 (December 10, 2009): 5919–23. http://dx.doi.org/10.1200/jco.2009.22.7041.

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Purpose We assessed changes in advanced cancer incidence and cancer mortality in eight randomized trials of breast cancer screening. Patients and Methods Depending on published data, advanced cancer was defined as cancer ≥ 20 mm in size (four trials), stage II+ (four trials), and ≥ one positive lymph node (one trial). For each trial, we obtained the estimated relative risk (RR) and 95% CI between the intervention and control groups, for both breast cancer mortality and diagnosis of advanced breast cancer. Using a meta-regression approach, log(RR-mortality) was regressed on log(RR-advanced cancer), weighting each trial by the reciprocal of the square of the standard error of log(RR) for mortality. Results RR for advanced breast cancer ranged from 0.69 (95% CI, 0.61 to 0.78) in the Swedish Two-County Trial to 0.97 (95% CI, 0.97 to 1.25) in the Canadian National Breast Screening Study-1 (NBSS-1) trial. Log(RR)s for advanced cancer were highly predictive of log(RR)s for mortality (R2 = 0.95; P < .0001), and the linear regression curve had a slope of 1.00 (95% CI, 0.76 to 1.25) after fixing the intercept to zero. The slope changed only slightly after excluding the Two-County Trial and the Canadian NBSS-1 and NBSS-2 trials. Conclusion In trials on breast cancer screening, for each unit decrease in incidence of advanced breast cancer, there was an equal decrease in breast cancer mortality. Monitoring of incidence of advanced breast cancer may provide information on the current impact of screening on breast cancer mortality in the general population.
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Phelps, Emma Elizabeth, Elizabeth Tutton, Matthew Costa, and Caroline Hing. "Unattainable equipoise in randomized controlled trials." Bone & Joint Open 2, no. 7 (July 1, 2021): 486–92. http://dx.doi.org/10.1302/2633-1462.27.bjo-2021-0055.r1.

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Aims To explore staff experiences of a multicentre pilot randomized controlled trial (RCT) comparing intramedullary nails and circular frame external fixation for segmental tibial fractures. Methods A purposeful sample of 19 staff (nine surgeons) involved in the study participated in an interview. Interviews explored participants’ experience and views of the study and the treatments. The interviews drew on phenomenology, were face-to-face or by telephone, and were analyzed using thematic analysis. Results The findings identify that for the treatment of segmental tibial fractures equipoise was a theoretical ideal that was most likely unattainable in clinical practice. This was conveyed through three themes: the ambiguity of equipoise, where multiple definitions of equipoise and a belief in community equipoise were evident; an illusion of equipoise, created by strong treatment preferences and variation in collective surgical skills; and treating the whole patient, where the complexity and severity of the injury required a patient-centred approach and doing the best for the individual patient took priority over trial recruitment. Conclusion Equipoise can be unattainable for rare injuries such as segmental tibial fractures, where there are substantially different surgical treatments requiring specific expertise, high levels of complexity, and a concern for poor outcomes. Surgeons are familiar with community equipoise. However, a shared understanding of factors that limit the feasibility of RCTs may identify instances where community equipoise is unlikely to translate into practice. Cite this article: Bone Jt Open 2021;2(7):486–492.
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Baggett, Travis P., Claire McGlave, Gina R. Kruse, Awesta Yaqubi, Yuchiao Chang, and Nancy A. Rigotti. "SmokefreeTXT for Homeless Smokers: Pilot Randomized Controlled Trial." JMIR mHealth and uHealth 7, no. 6 (June 4, 2019): e13162. http://dx.doi.org/10.2196/13162.

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Background Homeless smokers want to quit smoking but face numerous barriers to doing so, including pervasive smoking among peers and a lack of social support for quitting. An SMS (short message service) text messaging intervention could address these challenges by providing virtual daily support for homeless smokers who are trying to quit but coping with multiple triggers to smoke. Objective This study aimed to assess whether a free SMS text messaging program, added to evidence-based pharmacotherapy and counseling, improved smoking abstinence among homeless adult smokers. Methods From October 2015 to June 2016, we conducted an 8-week pilot randomized controlled trial (RCT) of nicotine patch therapy and weekly in-person counseling with (n=25) or without (n=25) SmokefreeTXT, a free SMS text messaging service administered by the National Cancer Institute (NCI) at Boston Health Care for the Homeless Program. All participants were provided with a mobile phone and a 2-month prepaid voice and text plan at no cost. SmokefreeTXT enrollees were sent 1 to 5 automated SMS text messages daily for up to 8 weeks and could receive on-demand tips for managing cravings, mood symptoms, and smoking lapses. The primary outcome was smoking abstinence, defined as an exhaled carbon monoxide count of <8 parts per million, assessed 14 times over 8 weeks of follow-up, and analyzed using repeated-measures logistic regression with generalized estimating equations. Other outcomes were use of SmokefreeTXT, assessed by data obtained from NCI; perceptions of SmokefreeTXT, assessed by surveys and qualitative interviews; and mobile phone retention, assessed by self-report. Results Of the SmokefreeTXT arm participants (n=25), 88% (22) enrolled in the program, but only 56% (14) had confirmed enrollment for ≥2 weeks. Among 2-week enrollees, the median response rate to interactive messages from SmokefreeTXT was 2.1% (interquartile range 0-10.5%). Across all time points, smoking abstinence did not differ significantly between SmokefreeTXT and control arm participants (odds ratio 0.92, 95% CI 0.30-2.84). Of SmokefreeTXT enrollees who completed exit surveys (n=15), two-thirds were very or extremely satisfied with the program. However, qualitative interviews (n=14) revealed that many participants preferred in-person intervention formats over phone-based, found the SMS text messages impersonal and robotic, and felt that the messages were too frequent and repetitive. Only 40% (10/25) of SmokefreeTXT arm participants retained their study-supplied mobile phone for the 8-week duration of the trial, with phone theft being common. Storing and charging phones were cited as challenges. Conclusions SmokefreeTXT, added to nicotine patch therapy and in-person counseling, did not significantly improve smoking abstinence in this 8-week pilot RCT for homeless smokers. SMS text messaging interventions for this population should be better tuned to the unique circumstances of homelessness and coupled with efforts to promote mobile phone retention over time. Trial Registration ClinicalTrials.gov NCT02565381; https://clinicaltrials.gov/ct2/show/NCT02565381 (Archived by WebCite at http://www.webcitation.org/78PLpDptZ)
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Boutron, Isabelle, Douglas G. Altman, Sally Hopewell, Francisco Vera-Badillo, Ian Tannock, and Philippe Ravaud. "Impact of Spin in the Abstracts of Articles Reporting Results of Randomized Controlled Trials in the Field of Cancer: The SPIIN Randomized Controlled Trial." Journal of Clinical Oncology 32, no. 36 (December 20, 2014): 4120–26. http://dx.doi.org/10.1200/jco.2014.56.7503.

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Purpose We aimed to assess the impact of spin (ie, reporting to convince readers that the beneficial effect of the experimental treatment is greater than shown by the results) on the interpretation of results of abstracts of randomized controlled trials (RCTs) in the field of cancer. Methods We performed a two-arm, parallel-group RCT. We selected a sample of published RCTs with statistically nonsignificant primary outcome and with spin in the abstract conclusion. Two versions of these abstracts were used—the original with spin and a rewritten version without spin. Participants were clinician corresponding authors of articles reporting RCTs, investigators of trials, and reviewers of French national grants. The primary outcome was clinicians' interpretation of the beneficial effect of the experimental treatment (0 to 10 scale). Participants were blinded to study hypothesis. Results Three hundred clinicians were randomly assigned using a Web-based system; 150 clinicians assessed an abstract with spin and 150 assessed an abstract without spin. For abstracts with spin, the experimental treatment was rated as being more beneficial (mean difference, 0.71; 95% CI, 0.07 to 1.35; P = .030), the trial was rated as being less rigorous (mean difference, −0.59; 95% CI, −1.13 to 0.05; P = .034), and clinicians were more interested in reading the full-text article (mean difference, 0.77; 95% CI, 0.08 to 1.47; P = .029). There was no statistically significant difference in the clinicians' rating of the importance of the study or the need to run another trial. Conclusion Spin in abstracts can have an impact on clinicians' interpretation of the trial results.
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Fawzy, Mohamed, Mai Emad, Ali Mahran, Mohamed Y. Abdelrahman, Ahmed N. Fetih, Hazem Abdelghafar, Mohamed A. Elsuity, Hend Rashed, and Mohamed Sabry. "A randomized controlled trial of laser-assisted ICSI." Human Reproduction 35, no. 12 (September 30, 2020): 2692–700. http://dx.doi.org/10.1093/humrep/deaa160.

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Abstract STUDY QUESTION Does the use of a laser to open the zona pellucida during ICSI (laser assisted or LA-ICSI) improve oocyte survival, embryo development and clinical outcomes? SUMMARY ANSWER Compared to conventional ICSI, LA-ICSI increased rates of oocyte survival and some aspects of embryo development but it did not alter the ongoing pregnancy rate; after adjusting for oocyte survival, there was no beneficial effect of LA-ICSI on embryo development and utilization. WHAT IS KNOWN ALREADY Oocyte degeneration occurs in a 10th of mature oocytes after ICSI. Pilot studies suggest that LA-ICSI may improve oocyte survivability. STUDY DESIGN, SIZE, DURATION In a randomized controlled trial, 966 couples (16 122 metaphase II oocytes) were allocated to receive LA-ICSI (intervention) or conventional ICSI (control) between 17 September 2018 and 5 August 2019. Oocyte survival (primary endpoint), embryo development and ongoing pregnancy rates were compared. PARTICIPANTS/MATERIALS, SETTING, METHODS Couples included in this study were recommended for ICSI due to female or male factor, unexplained infertility or a combination of factors. Patients were ineligible to participate in the study if they had uterine abnormality including thin endometrium, recurrent pregnancy loss, endometriosis or a severe medical condition. Concealed randomization to LA-ICSI or conventional ICSI, allocated in a 1:1 ratio, took place on stimulation Day 1 with replacement of blastocysts on only Day 5. The primary endpoint was oocyte survival with membrane integrity 24 h after the ICSI procedure. The sample size was estimated to detect a 3% increase in oocyte survival after LA-ICSI with 99% power at a 1% significance level. This also permitted the detection of 10% increase in ongoing pregnancy rate after LA-ICSI with 85% power at 5% alpha level. We used Poisson regression with zero-inflation for count data to estimate relative risk (RR) with 95% CI and logistic regression for clinical outcomes to estimate odds ratio (OR) with 95% CI. Both models adjusted for age as a covariate. MAIN RESULTS AND THE ROLE OF CHANCE Compared with conventional ICSI, LA-ICSI resulted in a higher number of surviving oocytes (RR 1.08, 95% CI 1.05–1.12, P &lt; 0.001), as well as a higher number of fertilized oocytes (RR 1.08, 95% CI 1.04–1.13, P &lt; 0.001) and utilizable blastocysts (RR 1.09, 95% CI 1.04–1.15, P &lt; 0.001). Sensitivity analyses adjusted for oocyte survival showed no between-group difference in utilizable blastocysts (OR 1.01, 95% CI 0.95–1.08, P = 0.73) and by calculating the mean rate, a reduction in utilizable blastocysts was shown (RR 0.95, 95% CI 0.94–0.97, P &lt; 0.001). Ongoing pregnancy showed no between-group difference (LA-ICSI 179/489 (37%) vs ICSI 201/477 (42%), OR 0.79, 95% CI 0.61–1.03, P = 0.09). LIMITATIONS, REASONS FOR CAUTION It was not possible to blind the embryologists involved in the ICSI procedure. However, there was concealment of randomization and blinding of outcome assessments reducing the risk of selection and measurement bias. WIDER IMPLICATIONS OF THE FINDINGS A beneficial effect of LA-ICSI on oocyte survival should be shown to improve clinical outcomes, before its use in clinical practice is justified. STUDY FUNDING/COMPETING INTEREST(S) The study received no funding, and the authors declare that there are no conflicts of interest. TRIAL REGISTRATION NUMBER NCT03665103 TRIAL REGISTRATION DATE 11 September 2018 DATE OF FIRST PATIENT'S ENROLMENT 17 September 2018
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