• 대한치과교정학회지
• /
• 제54권6호
• /
• pp.374-391
• /
• 2024

Objective: This meta-epidemiological study aimed to determine whether optimal sample size calculation was applied in orthodontic cluster randomized trials (CRTs). Methods: Orthodontic randomized clinical trials with a cluster design, published between January 1, 2017 to December 31, 2023, in leading orthodontic journals were sourced. Study selection was undertaken by two independent authors. The study characteristics and variables required for sample size calculation were also extracted by the authors. The design effect for each trial was calculated using an intra-cluster correlation coefficient of 0.1 and the number of teeth in each cluster to recalculate the sample size. Descriptive statistics for the study characteristics, summary values for the design effect, and sample sizes were provided. Results: One-hundred and five CRTs were deemed eligible for inclusion. Of these, 100 reported sample size calculation. Nine CRTs (9.0%) did not report any effect measures for the sample size calculation, and a few did not report any power assumptions or significance levels or thresholds. Regarding the specific variables for the cluster design, only one CRT reported a design effect and adjusted the sample size accordingly. Recalculations indicated that the sample size of orthodontic CRTs should be increased by a median of 50% to maintain the same statistical power and significance level. Conclusions: Sample size calculations in orthodontic cluster trials were suboptimal. Greater awareness of the cluster design and variables is required to calculate the sample size adequately, to reduce the practice of underpowered studies.

• 한국임상수의학회지
• /
• 제31권4호
• /
• pp.288-292
• /
• 2014

A critical assumption of the standard sample size calculation is that the response (outcome) for an individual patient is completely independent to that for any other patient. However, this assumption no longer holds when there is a lack of statistical independence across subjects seen in cluster randomized designs. In this setting, patients within a cluster are more likely to respond in a similar manner; patient outcomes may correlate strongly within clusters. Thus, direct use of standard sample size formulae for cluster design, ignoring the clustering effect, may result in sample size that are too small, resulting in a study that is under-powered for detecting the desired level of difference between groups. This paper revisit worked examples for sample size calculation provided in a previous paper using nomogram to easy to access. Then we present the concept of cluster design illustrated with worked examples, and introduce design effect that is a factor to inflate the standard sample size estimates.

• 대한한방내과학회지
• /
• 제44권6호
• /
• pp.1197-1211
• /
• 2023

Objectives: This study presents evidence by analyzing the research trends in acupuncture treatment for cluster headache in the last 10 years. Methods: Randomized controlled trials (RCTs) about acupuncture for cluster headache were searched from the China National Knowledge Infrastructure, PubMed, Cochrane Library, Oriental Medicine Advanced Searching Integrated System, ScienceON, Korean Studies Information Service System, and Research Information Sharing Service. The search terms were the combinations of "cluster headache", "acupuncture", and "needle therapy", and the articles were restricted to those published between 2013 and 2023. Only RCTs were selected. The risk of bias (RoB) was assessed according to the revised Cochrane RoB2 criteria. Results: Six RCTs were selected and analyzed in this review. All selected studies were conducted in China. All RCTs comprised 628 participants. Manual acupuncture was used in all studies. Acupuncture targeting the sphenopalatine ganglion was performed in two papers published after 2020. ST8, Ex-HIN3, and GB14 were the most frequently used acupoints in acupuncture treatment. The most commonly used indicators for evaluation were headache attack frequency, clinical efficacy, and the visual analog scale. In each study, adding acupuncture treatment to conventional therapy had significant effects in relieving the symptoms of cluster headaches. Conclusion: The results suggest that acupuncture is an effective treatment for cluster headache. To ensure objective evidence for the effectiveness of acupuncture treatment in cluster headache, it is important to continue large-scale case reports and RCTs.

• Journal of Gastric Cancer
• /
• 제20권2호
• /
• pp.115-126
• /
• 2020

Peritoneal metastasis (PM) frequently occurs in patients with gastric cancer (GC) and confers a dismal prognosis despite advances in systemic chemotherapy. While systemic chemotherapy has poor peritoneal penetration, intraperitoneal (IP) chemotherapy remains sequestered, resulting in high peritoneal drug concentrations with less systemic side-effects. The first application of IP treatment was hyperthermic intraperitoneal chemotherapy (HIPEC) with cytoreductive surgery (CRS) for gastric cancer peritoneal metastasis (GCPM); but was associated with an increased morbidity and mortality rate without significantly improving overall survival (OS). While CRS confers limited benefit, the potential role of prophylactic HIPEC and laparoscopic neoadjuvant HIPEC are currently being evaluated. Combination systemic and IP chemotherapy (SIPC) gained popularity in the 1990s, since it provided the benefits of IP treatment while reducing surgical morbidity, demonstrating promising early results in multiple Phase II trials. Unfortunately, these findings were not confirmed in the recent PHOENIX-GC randomized controlled trial; therefore, the appropriate treatment for GCPM remains controversial. Small observational studies from Japan and Singapore have reported successful downstaging of PM in GC patients receiving SIPC who subsequently underwent conversion gastrectomy with a median OS of 21.6-34.6 months. Recently, the most significant development in IP-directed therapy is pressurized IP aerosol chemotherapy (PIPAC). Given that aerosol chemotherapy achieves a wider distribution and deeper penetration, the outcomes of multiple ongoing trials assessing its efficacy are eagerly awaited. Indeed, IP-directed therapy has evolved rapidly in the last 3 decades, with an encouraging trend toward improved outcomes in GCPM, and may offer some hope for an otherwise fatal disease.

• Journal of Dental Anesthesia and Pain Medicine
• /
• 제21권4호
• /
• pp.311-319
• /
• 2021

The use of aromatherapy for the reduction of anxiety levels during dental treatment procedures has been well established in the literature; however, there is limited evidence regarding its efficacy. The present meta-analysis is an attempt to assess the association between the use of aromatherapy and anxiety levels among dental patients. A comprehensive search was conducted across Medline, Scopus, Web of Science, EBSCO host, Cochrane databases, and Google Scholar for studies evaluating aromatherapy and anxiety level among dental patients. PRISMA guidelines were followed for the meta-analysis. Randomized and cluster-randomized trials comparing aromatherapy with controls were included. The random-effects model was used to assess the mean differences in anxiety levels of patients visiting dental OPD. The significance value was set at P < 0.05. Six studies were identified that met the requirements for inclusion. Aromatherapy was significantly associated with reduction in patient anxiety levels during dental treatment (pooled mean difference: -3.36 [95% CI, -3.77 - -2.95, P = 0.00001). Low heterogeneity was noted between studies (I² = 1%, P = 0.41) analyzed in the meta-analysis. High certainty of the evidence was obtained from the association between the use of aromatherapy and dental anxiety. This meta-analysis suggests that aromatherapy is effective in reducing dental anxiety. When used judiciously, the results of this work should encourage the use of aromatherapy to reduce patient anxiety levels during dental procedures