A Randomized Clinical Trial

Funding Information: The authors would like to acknowledge the support of the Portuguese Society of Gastroenterology by granting the use of the REDCap software. Study data were collected and managed using REDCap (Research Electronic Data Capture) tools hosted at Sociedade Portuguesa de Gastrenterologia. REDCap is a secure, Web-based software platform designed to support data capture for research studies, providing (1) an intuitive interface for validated data capture; (2) audit trails for tracking data manipulation and export procedures; (3) automated export procedures for seamless data downloads to common statistical packages; and (4) procedures for data integration and interoperability with external sources. Publisher Copyright: © 2022 The Author(s). Published by S. Karger AG, Basel.Background: Colorectal cancer (CRC) is a leading cause of cancer. The detection of pre-malignant lesions by colonoscopy is associated with reduced CRC incidence and mortality. Narrow band imaging has shown promising but conflicting results for the detection of serrated lesions. Methods: We performed a randomized clinical trial to compare the mean detection of serrated lesions and hyperplastic polyps ≥10 mm with NBI or high-definition white light (HD-WL) withdrawal. We also compared all sessile serrated lesions (SSLs), adenoma, and polyp prevalence and rates. Results: Overall, 782 patients were randomized (WL group 392 patients; NBI group 390 patients). The average number of serrated lesions and hyperplastic polyps ≥10 mm detected per colonoscopy (primary endpoint) was similar between the HD-WL and NBI group (0.118 vs. 0.156, p = 0.44). Likewise, the adenoma detection rate (55.2% vs. 53.2%, p = 0.58) and SSL detection rate (6.8% vs. 7.5%, p = 0.502) were not different between the two study groups. Withdrawal time was higher in the NBI group (10.88 vs. 9.47 min, p = 0.004), with a statistically nonsignificant higher total procedure time (20.97 vs. 19.30 min, p = 0.052). Conclusions: The routine utilization of narrow band imaging does not improve the detection of serrated class lesions or any pre-malignant lesion and increases the withdrawal time.publishersversionepub_ahead_of_prin

A randomized clinical trial

Funding: The authors thank Marisa Almeida, Susana Costa, Rui Lourenco¸ and Sara Zorrinha from ACES Central − Primary Health Care Centers for the precious collaboration in the field work. We would like to deeply thank the collaborating of the following companies: Instituto Sao Joao de Deus, OKM ~ − Química Ortopedica, Lola − J. Andrade Ferreira Neves, Sensor Medica and Pierre Fabre Por- tugal. This work was supported by the CENIE (International centre on Ageing) [grant number 0348_CIE_6_E].Aims: Determine the effectiveness of custom-made orthopedic footwear (OF) and total contact plantar orthoses (PO) on the quality of life (QoL) and functionality of people with type 2 diabetes with diabetic peripheral neuropathic (DPN). Methods: Randomized clinical study with 2 parallel intervention groups and pre- and post-test analysis. In the standard footwear group (SFg), PO and education on foot self-care were applied and in the orthopedic footwear group (OFg) the same intervention was applied, but with personalized OF. A total of 43 type 2 diabetic patients with DPN aged 61 – 76 years were randomized: 20 in to SFg and 23 to OFg. Michigan Neuropathy Screening Instrument (MNSI) was used to screen for DPN. QoL was assessed with Short Form–36 and functional level was evaluated by Lower Extremity Functional Scale (LEFS), 6 physical tests and center of pressure (CoP) oscillation. Results: No differences in QoL were found between groups. OFg showed a better functional reach and mediolateral displacement of CoP (p ≤ 0.05). Conclusions: The OF does not show evidence on functional and QoL improvement in low-risk type 2 diabetic patients with neuropathy but both groups improved significantly in functional tests. The PO showed clinical value in these patients, so a regular and specialized treatment with appropriate footwear and plantar orthoses can play an important role in reducing the complications of diabetic neuropathy.publishersversionpublishe

a prospective randomized clinical trial

학위논문(박사) -- 서울대학교대학원 : 의과대학 의학과, 2021.8. 신형진.Background: Atelectasis commonly occurs during induction of general anesthesia in children, particularly infants. Maintaining self-respiration rather than using positive-pressure ventilation is known to reduce the risk of atelectasis. I hypothesized that maintaining spontaneous ventilation can reduce atelectasis formation during anesthetic induction in infants. The aim of this study was to compare spontaneous ventilation and manual positive-pressure ventilation in terms of atelectasis formation in infants. Methods: Infants undergoing general anesthesia were enrolled and randomized into either “spontaneous” group or “controlled” group. Oxygenation was provided after loss of consciousness, with spontaneous ventilation was maintained in the “spontaneous” group while conventional bag-mask ventilation was provided in the “controlled” group, with fraction of inspired oxygen of 100%. After 5 minutes of oxygenation, patient’s chest was divided into 12 observational area with combination of right/left, upper/lower, anterior/lateral/posterior regions and lung ultrasound was performed to compare atelectasis formation between the groups. For each region, both juxtapleural consolidation and presence of B-line were evaluated and separately graded with scores 0, 1, 2 or 3, larger number representing worse condition. Definition of atelectasis was set as presence of consolidation of score 2 or 3 in any regions of the chest. Exclusion criteria were history of hypoxemia during previous general anesthesia, development of a respiratory tract infection within 1 month, current intubation or tracheostomy cannulation, need for rapid sequence intubation, preterm birth and age within 60 weeks of the postconceptional age, and the presence of contraindications for rocuronium or sodium thiopental. Results: Atelectasis after oxygenation was seen in seven (26.9%) out of 26 patients in the “spontaneous” group and 22 (73.3%) out of 30 patients in the “controlled” group (P = 0.001). The relative risk of atelectasis in the “spontaneous” group was 0.391 (95% CI 0.211 to 0.723). Regarding ultrasound pictures of consolidation, the total sum score and sum of scores in the dependent regions were significantly lower in the “spontaneous” group than in the “controlled” group (P = 0.007, P = 0.001, respectively). Within patients, the posterior region showed significantly higher consolidation score and B-line score compared to the anterior and lateral regions. There was a strong positive correlation between consolidation score and B-line score for both groups. In the “controlled” group, there was a moderate negative correlation between age and total B-line score. Conclusions: Maintaining spontaneous ventilation during induction of general anesthesia has preventive effect against atelectasis in infants, particularly in the dependent portion of the lung.연구 배경: 소아의 마취 유도 시 무기폐는 흔하게 발생하며, 영아에서는 그 빈도가 더욱 높다. 양압환기 시보다 자발호흡이 유지되는 상황에서 무기폐의 발생 위험이 낮은 것은 어느 정도 알려져 있으나, 현재까지는 영아에서 마취 유도 시 자발호흡을 유지시키면서 무기폐 발생을 관찰한 전향적 연구는 보고된 바가 없다. 연구 목표: 본 연구에서는 1세 미만의 영아에서 마취 유도 중 자발호흡을 유지하는 경우 그렇지 않은 경우보다 무기폐의 발생률을 줄일 수 있다는 것을 가설로 하고, 그 가설을 검증하기 위한 전향적 연구를 계획하였다. 연구 방법: 전신마취 하 수술을 받기로 예정된 만 1세 미만의 영아 60명을 대상으로 연구를 진행하였다. 환자들을 자발호흡을 유지하는 “spontaneous” 군과, 용수 양압 환기를 유지하는 “controlled” 군으로 무작위로 배정하였다. 통상적인 방법으로 마취 유도 후, “spontaneous” 군은 안면 마스크로 산소를 공급하면서 자발호흡을 유지하였고, “controlled” 군은 안면 마스크를 통해 백-마스크 환기를 시행하였다. 5분간 산소 공급 후 환자의 폐를 12개의 구역으로 나누어 초음파로 관찰하고 무기폐 발생 여부를 확인하고 비교하였다. 연구 결과: 산소 공급 후 무기폐의 발생은 “spontaneous” 군에서는 26명 중 7명 (26.9%), “controlled” 군에서는 30명 중 22명 (73.3%) 에서 관찰되었다 (P = 0.001). “Spontaneous” 군의 무기폐 발생에 대한 상대 위험도는 0.391 (95% 신뢰구간 0.211 – 0.723) 이었다. 경화(consolidation) 소견을 관찰하였을 때, “controlled” 군에 비해 “spontaneous” 군에서 폐의 전체 구역 및 중력의 방향과 가까운 뒤쪽 구역에서의 경화 소견 점수가 낮았다 (P = 0.007, P = 0.001). 고찰: 1세 미만의 영아에서 마취 유도 시 자발호흡을 유지하는 것이 무기폐 발생률을 낮추는 결과가 관찰되었고, 그 차이는 폐의 중력의 방향과 가까운 뒤쪽 구역에서 더 저명하였다. 신경근 차단제의 사용이 필요하지 않은 수술을 위한 영아의 전신마취 시, 마취 유도 후 산소 공급 과정에서 무기폐의 발생률을 낮추기 위해 자발호흡을 유지하는 것을 고려해볼 수 있다.Abstract 3 List of Tables 8 List of Figures 9 1. Introduction 10 1. 1. Study Background 10 1. 2. Purpose of research 11 2. Methods 12 2. 1. Study design and population 12 2. 2. Randomization and blinding 12 2. 3. Study protocol 13 2. 4. Lung ultrasound examination 15 2. 5. Sample size calculation 17 2. 6. Statistical analysis 17 3. Results 20 4. Discussion 31 4. 1. Discussion about findings 31 4. 2. Mechanism-based interpretation 33 4. 3. Limitations 34 5. Conclusions 37 6. References 38 7. Abstract in Korean 44 8. Acknowledgements 46박

A Prospective randomized clinical trial

학위논문(박사) -- 서울대학교대학원 : 의과대학 의학과, 2021.8. 박기호.(1) Background: Mitomycin C (MMC) is commonly used during trabeculectomy. However, there is no consensus on which concentration should be used. We aimed to compare the efficacy and safety of 0.2 mg/ml and 0.4 mg/ml of MMC in eyes undergoing trabeculectomy. (2) Methods: Thirty-six eyes (36 glaucoma patients) were randomized to undergo a trabeculectomy with 0.2 mg/ml or 0.4 mg/ml of MMC. The success rate was evaluated according to three criteria: (A) intraocular pressure (IOP) ≤18 mmHg and IOP reduction ≥20%; (B) IOP ≤15 mmHg and IOP reduction ≥25%; (C) IOP ≤12 mmHg and IOP reduction ≥30%. Cox’s proportional hazard model was used to identify the predictive factors for failure. Immunohistochemical procedures for matrix metalloproteinase (MMP) were performed on Tenon’s tissue. Bleb morphology was evaluated. Safety was assessed based on the incidence of complications. (3) Results: Of the 36 eyes, 19 underwent trabeculectomy with 0.2 mg/ml of MMC and 17 with 0.4 mg/ml. The success rates were 75, 67, and 47% at 6 months for criteria A, B, and C, respectively. There were no significant differences between the two groups. High MMP-9 staining and low preoperative IOP were associated with failure (hazard ratio (HR), 5.556; P = 0.033, and HR, 0.936; P = 0.033). Complications included hypotony in two eyes (6%), hyphema in one eye (3%), and choroidal detachment in one eye (3%). (4) Conclusions: Trabeculectomy with 0.2 mg/ml and 0.4 mg/ml of MMC showed similar IOP-control effects similar to those recorded in previous studies, along with a low rate of complications. There was no significant difference in efficacy or safety between the 0.2 mg/ml and 0.4 mg/ml MMC groups.배경: 마이토마이신씨는 섬유주절제술에서 흔하게 사용된다. 하지만 어느 농도로 사용해야 하는지에 대해서는 아직 확립되지 않았다. 이에 우리는 섬유주절제술 수술 시에 각각 0.2 mg/ml와 0.4 mg/ml 농도의 마이토마이신씨를 사용했을 때의 유효성과 안정성을 비교해보고자 한다. 방법: 36명의 녹내장 환자를 무작위 배정법으로 나누어 섬유주절제술 수술 시에 0.2mg/ml 또는 0.4mg/ml 농도의 마이토마이신씨를 사용하였다. 수술의 성공은 다음의 3가지인 A) 안압 ≤18 mmHg 와 안압 하강률 ≥20%; (B) 안압 ≤15 mmHg와 안압 하강률≥25%; (C) 안압 ≤12 mmHg와 안압 하강률 ≥30%로 정의하였다. 콕스비례위험모형을 이용하여 실패를 예상할 수 있는 요소를 확인하였다. 면역조직화학기법을 사용하여 테논낭의 기질금속단백분해효소를 분석하였다. 또한 여과포 모양도 분석하였다. 안전성은 합병증의 발생률로 분석하였다. 결과: 36명 중 19명이 0.2 mg/ml 농도, 17명이 0.4 mg/ml 농도의 MMC를 이용하여 수술을 받았다. 수술 후 6개월 후 성공률은 A, B, C 각각을 기준으로 각각 75, 67, 그리고 47%였으며 두 군 사이에 유의한 차이는 없었다. 높은 정도의 기질금속단백분해효소-9의 발현과 낮은 술전 안압이 실패와 관련이 있었다. (hazard ratio (HR), 5.556; P = 0.033, and HR, 0.936; P = 0.033), 합병증으로는 저안압이 2안 (6%), 전방출혈이 1안 (3%), 그리고 맥락막 박리가 1안 (3%)에서 발생하였다. 결론: 0.2 mg/ml와 0.4 mg/ml농도의 마이토마이신씨를 이용한 섬유주절제술은 비슷한 정도의 안압하강 효과를 보였으며 낮은 빈도의 합병증을 보여주었다. 두 군 사이에 유효성과 안전성은 유의한 차이를 보이지 않았다.1. Introduction 1 2. Materials and Methods 2 2.1. Study design 2 2.2. Subjects 3 2.3. Preoperative assesement 3 2.4. Randomization 4 2.5. Surgical procedure 5 2.6. Postoperative assessment 5 2.7. Experimental procedures 6 2.8. Outcome evaluations 7 2.9. Statistics 7 2.10. Sample size 8 3. Results 9 3.1. Subjects 9 3.2. Changes of intraocular pressure and number of glaucoma medications 9 3.3. Success rates and the predictive factors for surgical failure 10 3.4. Bleb morphology 11 3.5. Complications and additional procedurs 11 4. Discussion 31 6. References 38 7. 국문초록 45 List of Tables . [Table 1] 14 [Table 2] 17 [Table 3] 22 [Table 4] 26 [Table 5] 28 List of Figures . [Figure 1] 29 [Figure 2] 30박

Reply - Letter to the Editor - Malnutrition: The kiss of grim reaper

Conducting a large, multicenter, prospective, randomized clinical trial poses a number of challenges. In particular, the successful completion of the trial is based on devising a protocol which could yield to clinically relevant answers yet no becoming so complex and sophisticated to prevent centers' participation and patients' enrollment. Consequently, the methodology of any trial reflects the clinical questions it tries to address

Zinc Gluconate in the Treatment of Dysgeusia—a Randomized Clinical Trial

In the treatment of dysgeusia, the use of zinc has been frequently tried, with equivocal results. The aim of the present randomized clinical trial, which involved a sufficiently large sample, was therefore to determine the efficacy of zinc treatment. Fifty patients with idiopathic dysgeusia were carefully selected. Zinc gluconate (140 mg/day; n = 26) or placebo (lactose; n = 24) was randomly assigned to the patients. The patients on zinc improved in terms of gustatory function (p < 0.001) and rated the dysgeusia as being less severe (p < 0.05). Similarly, signs of depression in the zinc group were less severe (Beck Depression Inventory, p < 0.05; mood scale, p < 0.05). With the exception of the salivary calcium level, which was higher in the zinc patients (p < 0.05), no other significant group differences were found. In conclusion, zinc appears to improve general gustatory function and, consequently, general mood scores in dysgeusia patients

Behavioral Couples Therapy for Smoking Cessation: A Pilot Randomized Clinical Trial

Introduction—Behavioral couples therapy (BCT) has been found to improve long-term abstinence rates in alcohol- and substance-dependent populations but has not been tested for smoking cessation. This pilot study examined the feasibility and acceptability of BCT for smoking-discordant couples. Methods—Forty-nine smokers (smoking \u3e10 cigarettes/day) with non-smoking partners were randomized to receive a couples social support (BCT-S) intervention, or an individually-delivered smoking cessation (ST) treatment. The couples were married or cohabiting for at least one year, with partners who had never smoked or had not used tobacco in one year. Both treatments included seven weekly sessions and 8-weeks of nicotine replacement therapy. Participants were followed for six months post-treatment. The Partner Interaction Questionnaire (PIQ) was used to measure perceived smoking-specific partner support. Results—Participants were 67% male and 88% White. Biochemically-verified cessation rates were 40.9%, 50% and 45% in BCT-S, and 59.1%, 50%, and 55% in ST, at end of treatment, 3-, and 6-months, respectively, and did not differ significantly between treatment conditions at any time point (all p’s \u3e .05). Perceived smoking-specific partner support at post-treatment did not significantly differ between treatment groups (M=2.45, SD .81 in BCT-S; M=2.27, SD .92 in ST; t(38) = .67, p = .51). Conclusions—Results of this pilot study do not provide support for the efficacy of BCT in smoking discordant couples

Selecting the primary endpoint in a randomized clinical trial: the ARE method

The decision on the primary endpoint in a randomized clinical trial is of paramount importance and the combination of several endpoints might be a reasonable choice. Gómez and Lagakos (2013) have developed a method that quantifies how much more efficient it could be to use a composite instead of an individual relevant endpoint. From the information provided by the frequencies of observing the component endpoints in the control group and by the relative treatment effects on each individual endpoint, the asymptotic relative efficiency (ARE) can be computed. This article presents the applicability of the ARE method as a practical and objective tool to evaluate which components, among the plausible ones, are more efficient in the construction of the primary endpoint. The method is illustrated with two real cardiovascular clinical trials and is extended to allow for different dependence structures between the times to the individual endpoints. The influence of this choice on the recommendation on whether or not to use the composite endpoint as the primary endpoint for the investigation is studied. We conclude that the recommendation between using the composite or the relevant endpoint only depends on the frequencies of the endpoints and the relative effects of the treatment.Peer ReviewedPostprint (author's final draft

Surgical Outcomes Research Based on Administrative Data: Inferior or Complementary to Prospective Randomized Clinical Trials?

The importance of surgical research has gained new prominence over the past decades as the relevance of well designed and well conducted studies has become increasingly evident. There are two basic but diametrically different methods of conducting research: the prospective randomized clinical trial and the retrospective surgical outcomes study based on administrative data. Administrative databases contain data that were initially collected for purposes other than scientific research. Whereas the prospective randomized clinical trial is familiar to most surgeons, surgical outcomes research based on administrative data constitutes a genre of investigation that is often unfamiliar to and even disparaged by the surgical community. In the present article, the strengths and weaknesses of both prospective randomized clinical trials and retrospective surgical outcomes research are discussed. Specifically, the advantages and limitations of investigations based on large administrative databases are outlined. Because both study designs play an important role in surgical research, carefully designed and implemented surgical outcomes research based on administrative data should be viewed as being complementary and not inferior to prospective randomized clinical trial