Perspectives in Clinical Research最新文献_第10页

Declaration of Helsinki: Can it still serve as a North star for ethics in regulatory trials? 赫尔辛基宣言：它还能在监管试验中成为道德的北极星吗？

Q2 Medicine

Perspectives in Clinical Research

Pub Date : 2023-01-01 Epub Date: 2023-01-06 DOI: 10.4103/picr.picr_247_22

Sanish Davis

引用次数: 0

Electronic health record interoperability using FHIR and blockchain: A bibliometric analysis and future perspective 使用FHIR和区块链的电子健康记录互操作性:文献计量学分析和未来展望

Q2 Medicine

Perspectives in Clinical Research

Pub Date : 2023-01-01 DOI: 10.4103/picr.picr_272_22

Gaurav Anand, Divya Sadhna

Electronic health records (EHRs) constitute vital statistics, current health condition, ongoing therapies, and patient data; hence, their interoperability could be useful for epidemiologic and clinical research. Fast Healthcare Interoperability Resources (FHIR) and blockchain are currently “in-use” and tested for exchange of such data. The annual scientific production of publications for both FHIR and blockchain shows steady growth. The data interoperability and electronic data interchange have been introduced in the field of EHR in 2020, hence inferring that data interoperability is relatively a new domain. The thematic mapping suggested “interoperability” of EHR is well-developed and important for the structure of the research field.

电子健康记录(EHRs)包括生命统计数据、当前健康状况、正在进行的治疗和患者数据;因此，它们的互操作性可用于流行病学和临床研究。快速医疗互操作性资源(FHIR)和区块链目前正在“使用”中，并对这些数据的交换进行了测试。FHIR和区块链的年度科学出版物产量均呈现稳定增长。数据互操作性和电子数据交换在2020年被引入到电子医疗领域，因此数据互操作性是一个相对较新的领域。专题映射表明，电子病历的“互操作性”发展良好，对研究领域的结构具有重要意义。

引用次数: 0

Experience of the selected Ethics Committee of Pune city regarding the review of COVID-19 protocols during the pandemic. 浦那市选定的道德委员会在大流行期间审查新冠肺炎协议的经验。

Q2 Medicine

Perspectives in Clinical Research

Pub Date : 2023-01-01 Epub Date: 2022-11-02 DOI: 10.4103/picr.picr_2_22

Sonopant G Joshi, Abhijeet Ashok Safai, Samir Sumant Barve

A sudden upsurge in COVID-19 research during the pandemic in 2020 brought a tremendous workload over Ethics Committees (ECs). Altered lifestyles and changes in research-related approaches due to the pandemic posed a completely different scenario to ECs,[1] and compelled them to adopt new administrative and functional modalities.[2] In addition, the Indian Council of Medical Research (ICMR) released special guidelines for ethical review of research studies during the pandemic.[3] This study aimed at exploring the functioning and experiences of a selected EC from India during the pandemic.

引用次数: 1

Evaluation of medical adherence, adverse drug reactions, and quality of life in post tubercular obstructive airway disease. 结核后阻塞性呼吸道疾病的医疗依从性、药物不良反应和生活质量评估。

Q2 Medicine

Perspectives in Clinical Research

Pub Date : 2023-01-01 Epub Date: 2021-10-06 DOI: 10.4103/picr.PICR_55_21

Vinita Awasthi, Sarvesh Singh, Narendra Kumar, Manoj Kumar, Amod Kumar Sachan, Rajiv Garg, Rahul Kumar

Background: Increasing incidence of tuberculosis is intensifying the posttubercular obstructive airway disease (PTOAD) in developing countries. Currently, there are no standard treatment guidelines for the management of PTOAD patients. The present study aims to evaluate the prescribing pattern, adherence, adverse drug reactions (ADRs), and quality of life (QoL) in PTOAD patients.

Materials and methods: A prospective observational study was conducted to evaluate the prescriptions of PTOAD patients, estimating the medical adherence using Morisky 8-Item Medication Adherence Questionnaire, assessing ADRs using Hartwig's Severity Assessment Scale and assessing QoL using St. George's respiratory Questionnaire. Chi-square test, analysis of variance, paired t-test were used to compare the data. The significance of change in adherence status was assessed by Wilcoxon signed-rank test.

Results: A total of 94 prescriptions of PTOAD were analyzed. Inhaled long-acting muscarinic antagonist was prescribed to 31.9% of patients. The most common inhaled fixed dose combination was long-acting beta-2 agonist with corticosteroid, prescribed to 52.1% of patients. At final follow-up, maximum percentage of patients were found to be highly adherent, i.e. 56.4%. Overall, 34% of patients have complained about mild category of ADRs. A significant improvement in QoL was observed. At baseline, mean forced expiratory volume in 1 (FEV₁) was 64.66% ±23.61%, which increased significantly to 73.34% ±21.60% on final follow-up (P < 0.001).

Conclusion: Bronchodilators are the mainstay of treatment of PTOAD patients, since both the QoL and FEV1 were improved with treatments. However, to have good treatment outcome, strict adherence along with safety of the medications must be assured.

背景：在发展中国家，结核病发病率的增加加剧了青春期后阻塞性气道疾病（PTOAD）。目前，尚无标准的PTOAD患者治疗指南。本研究旨在评估PTOAD患者的处方模式、依从性、药物不良反应（ADR）和生活质量（QoL）。材料和方法：进行一项前瞻性观察性研究，评估PTOAD患者的处方，使用Morisky 8项药物依从性问卷评估药物依从性，使用Hartwig严重程度评估量表评估ADR，并使用圣乔治呼吸问卷评估生活质量。采用卡方检验、方差分析、配对t检验对数据进行比较。通过Wilcoxon符号秩检验评估依从性状态变化的显著性。结果：对94个PTOAD处方进行分析。31.9%的患者使用吸入长效毒蕈碱拮抗剂。最常见的吸入固定剂量组合是长效β-2激动剂和皮质类固醇，52.1%的患者使用。在最后的随访中，发现最大百分比的患者高度粘附，即56.4%。总体而言，34%的患者抱怨轻度ADR。观察到生活质量显著改善。在基线时，平均用力呼气容积（FEV1）为64.66%±23.61%，在最终随访时显著增加到73.34%±21.60%（P<0.001）。结论：支气管扩张剂是PTOAD患者的主要治疗药物，因为治疗后生活质量和FEV1都有所改善。然而，为了获得良好的治疗效果，必须确保严格遵守药物的安全性。

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引用次数: 0

Investigator initiatives for academic trials: Dilemmas and difficulties 学术试验的研究者主动性:困境和困难

Q2 Medicine

Perspectives in Clinical Research

Pub Date : 2023-01-01 DOI: 10.4103/picr.picr_247_23

Usharani Pingali

The strength of a country’s medical research capability can be gauzed by the number and quality of academic studies initiated and conducted in that country. Academic studies help bridge the knowledge lacunae between clinical trials and real-world scenarios and are pivotal in repurposing of existing drugs. The population-specific data generated by academic studies can help solve population-specific clinical queries and help in formulating precise guidelines and policies tailored to the specific population. To bolster the academic clinical trials arena in India, the Central Drugs Standard Control Organization has laid down precise rules and regulations pertaining to definition and conduct of academic clinical trials in “New Drugs and Clinical Trials Rules (NDCT), 2019.” As per NDCT 2019, an Academic clinical trial “means a clinical trial of a drug already approved for a certain claim and initiated by any investigator, academic or research institution for a new indication or new route of administration or new dose or new dosage form, where the results of such a trial are intended to be used only for academic or research purposes and not for seeking approval of the Central Licensing Authority or regulatory authority of any country for marketing or commercial purpose.”[1] Further, the rules state that, academic clinical trials should be conducted in accordance with the ethical principles specified in the National Ethical Guidelines for Biomedical and Health Research involving human participants provided by Indian Council of Medical Research.[2] However, unlike regulatory clinical trials, academic clinical trials require approval only from an ethics committee registered with Department of Health research. In addition, they have the overall responsibility of oversight, monitoring, audit, and compensation for adverse event related to the trial. The potential challenges of conducting Academic clinical trials as per NDCT 2019 and ICMR Ethical guidelines, 2017, have been expounded in excellent articles by Bhatt and Konwar et al.[3,4] Despite the release of NDCT 2019, the current academic clinical trial scenario is India is still in its infancy and lagging behind other developed countries. To understand the current landscape of academic clinical trials in India, a multicenter study published in this issue of the journal[5] was conducted among 100 academicians from 3 tertiary care centers, located at Mumbai, Maharashtra. The study was conducted in two phases: phase 1 focused on estimating the approximate number of academic clinical trials in India by analyzing academic interventional studies registered in Clinical Trials Registry of India between April 2019 and October 2022, while phase 2 of the study utilized a questionnaire consisting of four domains on knowledge, awareness, practical experience, and potential challenges faced in conduct of academic clinical trials. The present study was fairly designed with a validated questionnaire and conducted at instit

一个国家医学研究能力的强弱可以通过该国发起和开展的学术研究的数量和质量来衡量。学术研究有助于弥合临床试验和现实世界情景之间的知识空白，对现有药物的再利用至关重要。学术研究产生的特定人群数据可以帮助解决特定人群的临床问题，并有助于制定针对特定人群的精确指导方针和政策。为了加强印度的学术临床试验领域，中央药物标准控制组织在“2019年新药和临床试验规则(NDCT)”中制定了与学术临床试验的定义和实施有关的精确规则和条例。根据NDCT 2019，学术临床试验“是指已经批准某种权利要求的药物的临床试验，并由任何研究者、学术或研究机构发起，用于新的适应症或新的给药途径或新剂量或新剂型，此种试验的结果仅用于学术或研究目的，而不用于向任何国家的中央发牌机关或监管机关申请批准用于营销或商业目的。“[1]此外，规则规定，学术临床试验应按照印度医学研究委员会提供的涉及人类的《国家生物医学和健康研究伦理准则》中规定的伦理原则进行。[2]然而，与监管性临床试验不同，学术性临床试验只需要获得在卫生研究部门注册的伦理委员会的批准。此外，他们还全面负责监督、监测、审计和赔偿与试验有关的不良事件。Bhatt和Konwar等人在优秀的文章中阐述了根据2019年NDCT和2017年ICMR伦理指南进行学术临床试验的潜在挑战。[3,4]尽管发布了2019年NDCT，但目前的学术临床试验情况是印度仍处于起步阶段，落后于其他发达国家。为了了解印度学术临床试验的现状，在本期杂志上发表的一项多中心研究[5]对来自位于马哈拉施特拉邦孟买的3个三级医疗中心的100名院士进行了研究。该研究分两个阶段进行:第一阶段侧重于通过分析2019年4月至2022年10月期间在印度临床试验登记处注册的学术介入研究来估计印度学术临床试验的大致数量，而第二阶段研究使用了由知识、意识、实践经验和进行学术临床试验面临的潜在挑战四个领域组成的问卷。本研究设计合理，采用了一份经过验证的问卷，并在印度学术研究前沿的机构进行。虽然本研究的结果在对学术性临床试验的认识和认知方面是令人鼓舞的，但在学术性临床试验的审批和补偿方面仍存在一些模糊的认识。该研究的一个有趣发现是，在2020年COVID年期间，学术临床试验的注册数量有所增加，但随后的两年却在逐步下降。令人担忧的是，尽管89%的院士接受过学术性临床试验的专门培训，但在过去3年中，只有50%的院士实际进行过学术性临床试验。研究人员报告的主要挑战之一与获得伦理委员会的批准和资金有关。伦理委员会是学术临床试验的批准、监督、审计和补偿的最终权力机构，因此，平衡科学与伦理的任务非常艰巨。更复杂的是，根据ICMR的规定，学术临床试验的补偿规则仍然存在很多含糊不清的地方。伦理委员会关于学术临床试验的监督、审计和补偿的标准操作程序有标准化的余地。这突出了对伦理委员会的认证和对伦理委员会成员的有力培训的必要性，以使他们能够有效地评估、监督和审计学术临床试验。然而，研究者和伦理委员会面临的另一个挑战是关于行业赞助和用于商业目的。尽管签署了一份合同，声明该公司不会将结果用于商业目的，但伦理委员会和调查人员缺乏必要的时间、财政和法律资源，以确保学术临床试验的结果不会在世界任何地方用于商业目的。然而，这项研究存在一些局限性。

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引用次数: 0

Characteristics, attitudes, and the odds for positive attitude toward clinical trial: A study on Indonesian COVID-19 vaccine trial participants 特征、态度和对临床试验持积极态度的几率:对印度尼西亚COVID-19疫苗试验参与者的研究

Q2 Medicine

Perspectives in Clinical Research

Pub Date : 2023-01-01 DOI: 10.4103/picr.picr_71_23

Nani Maharani, Nuvi Gustriawanto, YettyM Nency, Endang Mahati, GlennF Yeremia, DimasT Anantyo, Rebriarina Hapsari, Mulyono Mulyono, SetyoG Pramudo, Nur Farhanah

Aims: This study was performed to understand the Indonesian population’s characteristics and the factors that contribute to a more positive attitude toward participation in a clinical trial. Methods: A cross-sectional survey was conducted involving 402 COVID-19 vaccine trial participants in Semarang, Indonesia, utilizing self-reporting questionnaires consisting of questions related to socio-demographic characteristics and statements in a 5-scaled Likert Scale to assess the attitude toward vaccine trial. The odds for positive attitude were analyzed using Ordinal Logistic Regression to obtain the odd-ratio and 95% confidence interval. The P < 0.05 was considered statistically significant. Results: Most of the respondents were adults aged 22–64-year-old (89.30%), males (63.68%), married (77.61%), worked as an employee (59.70%), obtained information about the clinical trial from the Public Health Service (41.29%), had a low education level (40.80%), a low monthly income level (68.41%), with no previous participation in a clinical trial (90.80%). All respondents showed a good attitude toward the trial, with low education level, nonemployment status, fewer or no previous participation in clinical trials, and getting the information from the public health centers were the main predictors for better attitude toward vaccine trials. Conclusion: There was a positive attitude toward vaccine trials in the Indonesian population. The positive attitude could be driven by having a low education level, nonemployment status, fewer or no previous participation in the clinical trial, and getting information from public health centers.

目的:本研究旨在了解印度尼西亚人群的特征以及对参与临床试验持更积极态度的因素。方法:对印度尼西亚三宝垄402名COVID-19疫苗试验参与者进行横断面调查，采用自报告问卷，包括与社会人口学特征相关的问题和李克特5量表的陈述，评估对疫苗试验的态度。采用有序Logistic回归分析积极态度的比值，得到奇比和95%置信区间。P < 0.05为差异有统计学意义。结果:调查对象以成人(89.30%)、男性(63.68%)、已婚(77.61%)、在职(59.70%)、从公共卫生服务部门获得临床试验信息(41.29%)、文化程度低(40.80%)、月收入低(68.41%)、未参加临床试验(90.80%)为主。受访者对疫苗试验的态度均较好，受教育程度低、未就业、较少或从未参加过临床试验，从公共卫生中心获得信息是对疫苗试验态度较好的主要预测因素。结论:印尼民众对疫苗试验持积极态度。受教育程度低、未就业、较少或从未参加过临床试验、从公共卫生中心获取信息等因素可以驱动积极态度。

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引用次数: 0

Gene therapy in India: Developments, challenges, and future directions 印度的基因治疗:发展、挑战和未来方向

Q2 Medicine

Perspectives in Clinical Research

Pub Date : 2023-01-01 DOI: 10.4103/picr.picr_119_22

Geeta Jotwani, V. Dalal, MunnaLal Yadav, Akanksha Bhawsar

引用次数: 0

Comparative study of efficacy and safety of cetirizine and bilastine in patients of chronic spontaneous urticaria: Open-label, randomized, parallel-group study 西替利嗪和bilastine治疗慢性自发性荨麻疹的疗效和安全性比较:开放标签、随机、平行组研究

Q2 Medicine

Perspectives in Clinical Research

Pub Date : 2023-01-01 DOI: 10.4103/picr.picr_28_23

MrunaliniVinay Kalikar, VishakhaV Sinha, JayeshIshwardas Mukhi, AkhilBhagwan Giradkar, Smita Sontakke

Purpose: Bilastine is a novel second-generation antihistaminic. Very few studies in Indian population have compared the safety and efficacy of bilastine with other second-generation antihistaminic like cetirizine. Hence, the present study was planned. Materials and Methods: This was a randomized, open-label comparative parallel group study conducted on 70 patients of chronic spontaneous urticaria (CSU). Patients either received cetirizine 10 mg or bilastine 20 mg once daily for 6 weeks. The primary endpoint was to find out the difference in the mean total symptom score (MTSS) at baseline and 6 weeks. The secondary endpoint was to find out changes in the scale of the number of wheals, change in pruritus scale, scale for size of wheal, change for interference of wheals with sleep, change in visual analog scale (VAS) for sedation, change in scale for intensity of erythema, and change in Scale for Extent of Skin Area Involvement (SESI). Results: Bilastine and cetirizine offer a significant reduction in MTSS, mean number of wheals, and mean pruritus scale at baseline to 1, 3, and 6 weeks. The mean difference in MTSS was significantly more in bilastine. Cetirizine showed a significant increase in VAS score for sedation as compared to bilastine. Both the drugs were well tolerated and safe. Adverse events like headache, gastric irritation, dryness of mouth, and sedation were more reported in cetirizine group. Conclusion: Bilastine was more efficacious than cetirizine in patients of CSU and the efficacy was seen earlier at 1 week, which was not seen in the cetirizine group.

目的:Bilastine是一种新型的第二代抗组胺药。在印度人群中很少有研究比较bilastine与其他第二代抗组胺药如西替利嗪的安全性和有效性。因此，计划进行本研究。材料和方法:这是一项随机、开放标签的比较平行组研究，对70例慢性自发性荨麻疹(CSU)患者进行了研究。患者接受西替利嗪10mg或bilastine 20mg，每日一次，持续6周。主要终点是找出基线和6周时平均总症状评分(MTSS)的差异。次要目的是了解皮疹数量、瘙痒程度、大小、干扰睡眠程度、镇静效果视觉模拟评分(VAS)、红斑强度评分、皮肤受累程度评分(SESI)的变化。结果:比拉斯汀和西替利嗪在基线至1、3和6周时显著降低MTSS、平均轮数和平均瘙痒量表。bilastine组MTSS的平均差异更大。西替利嗪的VAS镇静评分明显高于bilastine。这两种药物都具有良好的耐受性和安全性。西替利嗪组出现头痛、胃刺激、口干、镇静等不良反应较多。结论:比拉斯汀对CSU患者的疗效优于西替利嗪，且疗效早于西替利嗪组，西替利嗪组未见疗效。

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引用次数: 0

Analysis of serious adverse events reports: Review by an Institutional Ethics Committee of a tertiary care teaching hospital. 严重不良事件报告分析:由三级医疗教学医院机构伦理委员会审查。

Q2 Medicine

Perspectives in Clinical Research

Pub Date : 2022-10-01 Epub Date: 2021-07-12 DOI: 10.4103/picr.PICR_293_20

Ganesh Nathuji Dakhale, Mrunalini Vinay Kalikar, Akhil B Giradkar, Vishakha V Sinha

Background: Managing of SAE by all stakeholders i.e. principal investigator (PI), sponsor, and Institutional Ethics Committee (IEC), in an ethical manner is the most important indicator of participant safety during clinical trial. The present study was conducted with the objectives to assess the extent of regulatory compliance in reporting SAEs, relatedness and financial compensation given/recommended by various stakeholders.

Methods: This was a retrospective observational study which involved analysis of SAE's reviewed by IEC. Administrative approval for accessing the documents was obtained and complete confidentiality was maintained. A total of 66 SAE of 34 regulatory clinical trials reported from January 2014 to March 2020 were analyzed.

Result: When analyzed for relatedness, 16 (24.24%) of the reported SAEs were found related to the clinical trial and out of these, 7 were SAE of death. Among the remaining 50 SAEs, 48 (72.7 %) were not related to clinical trial .65 (98.48%) SAEs, initial report and final report were submitted to EC within timelines. All the 66 SAE reports were sent by EC within stipulated time as required by regulation.

Conclusion: The study concludes that 66 SAE reports were identified and there was no deviation in reporting timelines in initial reporting and due analysis report by PI and initial review by IEC in 65 SAE's. Similarly, analysis of SAE by IEC for relatedness, and provision of compensation to participant was achieved in majority of SAE. The study is unique in a way that qualitative and quantitative analysis of SAE reports was performed.

背景:在临床试验中，所有利益相关者(即主要研究者(PI)、发起人和机构伦理委员会(IEC))以道德的方式管理SAE是参与者安全的最重要指标。本研究的目的是评估报告SAEs的合规性程度、相关性以及各利益相关者给出/建议的财务补偿。方法:这是一项回顾性观察性研究，涉及IEC审查的SAE分析。取得了查阅文件的行政批准，并保持了完全保密。我们对2014年1月至2020年3月报告的34项监管性临床试验中的66项SAE进行了分析。结果:分析相关性时，16例(24.24%)报告的SAE与临床试验相关，其中7例为死亡SAE。其余50例SAEs中，48例(72.7%)与临床试验无关。65例(98.48%)SAEs的初始报告和最终报告均在规定时间内向EC提交。所有66份SAE报告均在规定时间内由EC按规定发送。结论:该研究得出了66份SAE报告，在65份SAE报告中，PI的初始报告和应有的分析报告以及IEC的初始审查报告的报告时间表没有偏差。同样，通过IEC对SAE的相关性进行分析，并向参与者提供补偿，在大多数SAE中都实现了。该研究的独特之处在于对SAE报告进行了定性和定量分析。

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引用次数: 0

A cross-sectional study of pre- and posttraining evaluation of inhaler use technique among outpatients with bronchial asthma or chronic obstructive pulmonary disease at a tertiary care hospital in India. 印度某三级医院支气管哮喘或慢性阻塞性肺疾病门诊患者吸入器使用技术培训前后评估的横断面研究

Q2 Medicine

Perspectives in Clinical Research

Pub Date : 2022-10-01 Epub Date: 2021-12-01 DOI: 10.4103/picr.picr_328_20

Selvaraj Nitya, Sivagourounadin Kiruthika, R Meenakshi, H Suriya, S Yuvarajan

Context: Management of asthma and chronic obstructive pulmonary disease (COPD) includes use of inhalers as an integral component of drug delivery. Awareness about inhaler devices along with demonstration of the usage of inhaler technique aids in the optimization of therapeutic outcome.

Aim: This study aimed to assess the correct use of inhaler technique following pre- and posttraining sessions for the management of COPD and asthma among pulmonary outpatients at a tertiary care hospital.

Settings: This prospective cross-sectional study was carried out among patients diagnosed with asthma or COPD and prescribed with inhaler medication in the form of pressurized metered-dose inhaler (pMDI), MDI with spacer, or dry powder inhaler (DPI).

Subjects and methods: The inhaler device use by the patients was assessed initially, followed by a demonstration on inhaler device technique, and reassessed post training using a checklist.

Statistical analysis: Comparison of the median total score of pretraining and posttraining inhaler technique was analyzed by Wilcoxon signed rank test. P < 0.05 was considered statistically significant.

Results: Out of 144 patients, 55.6%, 27.7%, and 16.7% of them were prescribed pMDI, MDI with spacer, and DPI, respectively. Post inhaler technique training, about 79.2% of the patients were able to demonstrate the inhaler technique correctly compared to 52.1% prior to training. A statistically significant difference in the median score of inhaler technique has been observed before and after training.

Conclusions: This study reports a significant improvement in the correct use of inhaler technique post training. In addition, the most frequent error among inhaler users was revealed to be in the breath actuation.

背景:哮喘和慢性阻塞性肺疾病(COPD)的管理包括使用吸入器作为给药的一个组成部分。对吸入器装置的认识以及使用吸入器技术的示范有助于优化治疗结果。目的:本研究旨在评估一家三级医院肺病门诊患者COPD和哮喘管理培训前后吸入器技术的正确使用。背景:这项前瞻性横断面研究是在诊断为哮喘或COPD的患者中进行的，这些患者使用吸入器药物，包括加压计量吸入器(pMDI)、带间隔剂的MDI或干粉吸入器(DPI)。受试者和方法:首先对患者使用的吸入器装置进行评估，随后对吸入器装置技术进行演示，并在培训后使用检查表进行重新评估。统计学分析:采用Wilcoxon符号秩检验比较训练前和训练后吸入器技术总分中位数。P < 0.05为差异有统计学意义。结果:144例患者中，分别有55.6%、27.7%和16.7%的患者使用pMDI、MDI加间隔剂和DPI。吸入器技术培训后，约79.2%的患者能够正确演示吸入器技术，而培训前为52.1%。在训练前后观察到吸入器技术的中位数得分有统计学意义的差异。结论:本研究报告了培训后吸入器技术正确使用的显著改善。此外，吸入器使用者中最常见的错误是呼吸驱动。

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引用次数: 1