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  • 文章类型: Journal Article
    自从美国视网膜专家协会的人工智能委员会在2020年制定了最初的工作组报告以来,人工智能(AI)领域已经看到了美国食品和药物管理局批准的AI平台的进一步采用以及AI在各种视网膜条件下的重大发展。随着这项技术的扩展,进一步提出了挑战,包括人工智能中使用的数据源,AI的民主,商业化,偏见,以及对人工智能技术提供者教育的需求。本委员会报告的总体重点是探讨这些最近的问题,因为它们与人工智能的持续发展及其与眼科和视网膜实践的整合有关。
    Since the Artificial Intelligence Committee of the American Society of Retina Specialists developed the initial task force report in 2020, the artificial intelligence (AI) field has seen further adoption of US Food and Drug Administration-approved AI platforms and significant development of AI for various retinal conditions. With expansion of this technology comes further areas of challenges, including the data sources used in AI, the democracy of AI, commercialization, bias, and the need for provider education on the technology of AI. The overall focus of this committee report is to explore these recent issues as they relate to the continued development of AI and its integration into ophthalmology and retinal practice.
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  • 文章类型: Journal Article
    背景:建议在妊娠期补充铁和叶酸以预防贫血,并可能改善其他产妇,怀孕,和婴儿结局。
    目的:研究孕期每日口服补铁的效果,单独或与叶酸或其他维生素和矿物质联合使用,作为产前保健的干预措施。
    方法:我们于2024年1月18日检索了Cochrane妊娠和分娩试验登记处(包括CENTRAL,MEDLINE,Embase,CINAHL,ClinicalTrials.gov,世卫组织国际临床试验注册平台,会议记录),并搜索了检索到的研究的参考列表。
    方法:评估口服补铁效果的随机或准随机试验,铁+叶酸,或铁+怀孕期间的其他维生素和矿物质。
    方法:综述作者独立评估试验资格,根据预定义的标准确定可信度,评估的偏见风险,提取的数据,并进行了准确性检查。我们使用GRADE方法来评估主要结局证据的确定性。我们预计试验之间的异质性很高;我们使用随机效应模型(平均治疗效果)汇总了试验结果。
    结果:我们纳入了57项试验,涉及48,971名女性。共有40项试验比较了每日口服补铁与安慰剂或不含铁的效果;8项试验评估了铁+叶酸与安慰剂或不含铁+叶酸的效果。与安慰剂或无铁相比,补充铁母体结局:怀孕期间补充铁可以减少母体贫血(4.0%对7.4%;风险比(RR)0.30,95%置信区间(CI)0.20至0.47;14项试验,13,543名女性;低确定性证据)和足月铁缺乏症(44.0%对66.0%;RR0.51,95%CI0.38至0.68;8项试验,2873名妇女;低确定性证据),并可能减少产妇足月缺铁性贫血(5.0%对18.4%;RR0.41,95%CI0.26至0.63;7项试验,2704名妇女;中度确定性证据),与安慰剂或不补充铁相比。产妇死亡可能几乎没有差异(2和4个事件,RR0.57,95%CI0.12至2.69;3项试验,14060名妇女;中度确定性证据)。不良反应的证据非常不确定(21.6%对18.0%;RR1.29,95%CI0.83至2.02;12项试验,2423名女性;非常低的确定性证据)和严重贫血(Hb<70g/L)在孕中期/晚期(<1%对3.6%;RR0.22,95%CI0.01至3.20;8项试验,1398名妇女;非常低的确定性证据)。没有临床试验报告临床疟疾或怀孕期间感染。婴儿结局:服用铁补充剂的女性可能不太可能有低出生体重的婴儿(5.2%对6.1%;RR0.84,95%CI0.72至0.99;12项试验,18,290名婴儿;中度确定性证据),与安慰剂或不补充铁相比。然而,婴儿出生体重的证据非常不确定(MD24.9克,95%CI-125.81至175.60;16项试验,18,554名婴儿;非常低的确定性证据)。早产可能几乎没有差异(7.6%对8.2%;RR0.93,95%CI0.84至1.02;11项试验,18,827名婴儿;中度确定性证据),新生儿死亡可能几乎没有差异(1.4%对1.5%,RR0.98,95%CI0.77至1.24;4项试验,17,243名婴儿;低确定性证据)或先天性异常,包括神经管缺陷(41对48例事件;RR0.88,95%CI0.58至1.33;4项试验,14,377名婴儿;低确定性证据)。与安慰剂或无铁+叶酸相比,铁+叶酸补充剂产妇结局:每日口服铁+叶酸补充剂可能减少足月产妇贫血(12.1%对25.5%;RR0.44,95%CI0.30至0.64;4项试验,1962年妇女;中度确定性证据),并且可以减少孕妇足月铁缺乏(3.6%对15%;RR0.24,95%CI0.06至0.99;1项试验,131名妇女;低确定性证据),与安慰剂或不含铁+叶酸相比。关于铁+叶酸对产妇缺铁性贫血的影响的证据非常不确定(10.8%对25%;RR0.43,95%CI0.17至1.09;1项试验,131名女性;非常低的确定性证据),或孕产妇死亡(无事件;1项试验;非常低的确定性证据)。不良反应的证据不确定(21.0%对0.0%;RR44.32,95%CI2.77至709.09;1项试验,456名妇女;低确定性证据),妊娠中期或晚期严重贫血的证据非常不确定(<1%对5.6%;RR0.12,95%CI0.02至0.63;4项试验,506名女性;非常低的确定性证据),与安慰剂或不含铁+叶酸相比。婴儿结局:婴儿低出生体重可能几乎没有差异(33.4%对40.2%;RR1.07,95%CI0.31至3.74;2项试验,1311名婴儿;低确定性证据),比较补充铁+叶酸与安慰剂或不补充铁+叶酸。怀孕期间接受铁+叶酸的女性所生的婴儿出生体重可能较高(MD57.73g,95%CI7.66至107.79;2项试验,1365名婴儿;中度确定性证据),与安慰剂或不含铁+叶酸相比。其他婴儿结局可能几乎没有差异,包括早产(19.4%对19.2%;RR1.55,95%CI0.40至6.00;3项试验,1497名婴儿;低确定性证据),新生儿死亡(3.4%对4.2%;RR0.81,95%CI0.51至1.30;1项试验,1793名婴儿;低确定性证据),或先天性异常(1.7%对2.4;RR0.70,95%CI0.35至1.40;1项试验,1652名婴儿;低确定性证据),比较补充铁+叶酸与安慰剂或不补充铁+叶酸。在疟疾流行国家共进行了19项试验,或者在有疟疾风险的环境中。没有研究报告母体临床疟疾;一项研究报告了胎盘疟疾的数据。
    结论:孕期每日口服补铁可以减少孕妇足月贫血和铁缺乏。对于其他母婴结局,组间几乎没有差异,或者证据不确定.未来的研究需要检查铁补充剂对其他母婴健康结果的影响,包括婴儿铁状态,增长,和发展。
    BACKGROUND: Iron and folic acid supplementation have been recommended in pregnancy for anaemia prevention, and may improve other maternal, pregnancy, and infant outcomes.
    OBJECTIVE: To examine the effects of daily oral iron supplementation during pregnancy, either alone or in combination with folic acid or with other vitamins and minerals, as an intervention in antenatal care.
    METHODS: We searched the Cochrane Pregnancy and Childbirth Trials Registry on 18 January 2024 (including CENTRAL, MEDLINE, Embase, CINAHL, ClinicalTrials.gov, WHO\'s International Clinical Trials Registry Platform, conference proceedings), and searched reference lists of retrieved studies.
    METHODS: Randomised or quasi-randomised trials that evaluated the effects of oral supplementation with daily iron, iron + folic acid, or iron + other vitamins and minerals during pregnancy were included.
    METHODS: Review authors independently assessed trial eligibility, ascertained trustworthiness based on pre-defined criteria, assessed risk of bias, extracted data, and conducted checks for accuracy. We used the GRADE approach to assess the certainty of the evidence for primary outcomes. We anticipated high heterogeneity amongst trials; we pooled trial results using a random-effects model (average treatment effect).
    RESULTS: We included 57 trials involving 48,971 women. A total of 40 trials compared the effects of daily oral supplements with iron to placebo or no iron; eight trials evaluated the effects of iron + folic acid compared to placebo or no iron + folic acid. Iron supplementation compared to placebo or no iron Maternal outcomes: Iron supplementation during pregnancy may reduce maternal anaemia (4.0% versus 7.4%; risk ratio (RR) 0.30, 95% confidence interval (CI) 0.20 to 0.47; 14 trials, 13,543 women; low-certainty evidence) and iron deficiency at term (44.0% versus 66.0%; RR 0.51, 95% CI 0.38 to 0.68; 8 trials, 2873 women; low-certainty evidence), and probably reduces maternal iron-deficiency anaemia at term (5.0% versus 18.4%; RR 0.41, 95% CI 0.26 to 0.63; 7 trials, 2704 women; moderate-certainty evidence), compared to placebo or no iron supplementation. There is probably little to no difference in maternal death (2 versus 4 events, RR 0.57, 95% CI 0.12 to 2.69; 3 trials, 14,060 women; moderate-certainty evidence). The evidence is very uncertain for adverse effects (21.6% versus 18.0%; RR 1.29, 95% CI 0.83 to 2.02; 12 trials, 2423 women; very low-certainty evidence) and severe anaemia (Hb < 70 g/L) in the second/third trimester (< 1% versus 3.6%; RR 0.22, 95% CI 0.01 to 3.20; 8 trials, 1398 women; very low-certainty evidence). No trials reported clinical malaria or infection during pregnancy. Infant outcomes: Women taking iron supplements are probably less likely to have infants with low birthweight (5.2% versus 6.1%; RR 0.84, 95% CI 0.72 to 0.99; 12 trials, 18,290 infants; moderate-certainty evidence), compared to placebo or no iron supplementation. However, the evidence is very uncertain for infant birthweight (MD 24.9 g, 95% CI -125.81 to 175.60; 16 trials, 18,554 infants; very low-certainty evidence). There is probably little to no difference in preterm birth (7.6% versus 8.2%; RR 0.93, 95% CI 0.84 to 1.02; 11 trials, 18,827 infants; moderate-certainty evidence) and there may be little to no difference in neonatal death (1.4% versus 1.5%, RR 0.98, 95% CI 0.77 to 1.24; 4 trials, 17,243 infants; low-certainty evidence) or congenital anomalies, including neural tube defects (41 versus 48 events; RR 0.88, 95% CI 0.58 to 1.33; 4 trials, 14,377 infants; low-certainty evidence). Iron + folic supplementation compared to placebo or no iron + folic acid Maternal outcomes: Daily oral supplementation with iron + folic acid probably reduces maternal anaemia at term (12.1% versus 25.5%; RR 0.44, 95% CI 0.30 to 0.64; 4 trials, 1962 women; moderate-certainty evidence), and may reduce maternal iron deficiency at term (3.6% versus 15%; RR 0.24, 95% CI 0.06 to 0.99; 1 trial, 131 women; low-certainty evidence), compared to placebo or no iron + folic acid. The evidence is very uncertain about the effects of iron + folic acid on maternal iron-deficiency anaemia (10.8% versus 25%; RR 0.43, 95% CI 0.17 to 1.09; 1 trial, 131 women; very low-certainty evidence), or maternal deaths (no events; 1 trial; very low-certainty evidence). The evidence is uncertain for adverse effects (21.0% versus 0.0%; RR 44.32, 95% CI 2.77 to 709.09; 1 trial, 456 women; low-certainty evidence), and the evidence is very uncertain for severe anaemia in the second or third trimester (< 1% versus 5.6%; RR 0.12, 95% CI 0.02 to 0.63; 4 trials, 506 women; very low-certainty evidence), compared to placebo or no iron + folic acid. Infant outcomes: There may be little to no difference in infant low birthweight (33.4% versus 40.2%; RR 1.07, 95% CI 0.31 to 3.74; 2 trials, 1311 infants; low-certainty evidence), comparing iron + folic acid supplementation to placebo or no iron + folic acid. Infants born to women who received iron + folic acid during pregnancy probably had higher birthweight (MD 57.73 g, 95% CI 7.66 to 107.79; 2 trials, 1365 infants; moderate-certainty evidence), compared to placebo or no iron + folic acid. There may be little to no difference in other infant outcomes, including preterm birth (19.4% versus 19.2%; RR 1.55, 95% CI 0.40 to 6.00; 3 trials, 1497 infants; low-certainty evidence), neonatal death (3.4% versus 4.2%; RR 0.81, 95% CI 0.51 to 1.30; 1 trial, 1793 infants; low-certainty evidence), or congenital anomalies (1.7% versus 2.4; RR 0.70, 95% CI 0.35 to 1.40; 1 trial, 1652 infants; low-certainty evidence), comparing iron + folic acid supplementation to placebo or no iron + folic acid. A total of 19 trials were conducted in malaria-endemic countries, or in settings with some malaria risk. No studies reported maternal clinical malaria; one study reported data on placental malaria.
    CONCLUSIONS: Daily oral iron supplementation during pregnancy may reduce maternal anaemia and iron deficiency at term. For other maternal and infant outcomes, there was little to no difference between groups or the evidence was uncertain. Future research is needed to examine the effects of iron supplementation on other maternal and infant health outcomes, including infant iron status, growth, and development.
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  • 文章类型: Systematic Review
    背景:中风患者经常面临严重影响其日常生活的残疾。营养不良是这些患者的常见问题,营养不良会严重影响卒中后的功能恢复。因此,营养治疗对于管理卒中结局至关重要.然而,它对残疾的影响,日常生活活动(ADL),和其他关键成果尚未得到充分探索。
    目的:评价营养治疗对脑卒中后患者减少残疾和改善ADL的作用。
    方法:我们搜索了Cochrane卒中组的试验记录,中部,MEDLINE(自1946年起)Embase(自1974年起),CINAHL(自1982年起),和AMED(从1985年起)至2024年2月19日。我们还搜索了试验和研究登记处(ClinicalTrials.gov,世界卫生组织国际临床试验注册平台)和参考文章列表。
    方法:我们纳入了随机对照试验(RCT),比较了营养治疗与安慰剂,日常护理,或中风后的一种营养疗法。营养治疗被定义为补充营养,包括能量,蛋白质,氨基酸,脂肪酸,维生素,矿物,通过口头,肠内,或肠胃外方法。作为一个比较器,一种营养疗法是指所有形式的营养疗法,排除定义用于干预组的特定营养疗法.
    方法:我们使用Cochrane的Screen4Me工作流程来评估初始搜索结果。两位综述作者独立筛选了符合纳入标准的参考文献,提取的数据,并使用GRADE方法评估偏倚风险和证据的确定性。我们计算了连续数据的平均差(MD)或标准化平均差(SMD)和二分数据的比值比(OR),95%置信区间(CI)。我们使用I2统计量评估异质性。主要结果是残疾和ADL。我们还评估了步态,营养状况,全因死亡率,生活质量,手和腿的肌肉力量,认知功能,物理性能,中风复发,吞咽功能,神经损伤,和并发症(不良事件)的发展作为次要结局。
    结果:我们确定了52个合格的RCT,涉及11,926名参与者。在急性期进行了36项研究,10在亚急性期,三个在急性期和亚急性期,还有三个在慢性期。23项研究包括缺血性中风患者,其中三名包括出血性中风患者,其中3例包括蛛网膜下腔出血(SAH)患者,23例包括缺血性或出血性卒中患者,包括SAH.有25种类型的营养补充剂用作干预措施。评估残疾和ADL作为结果的研究数量分别为9项和17项。对于使用口服能量和蛋白质补充剂的干预,这是这篇综述的主要干预措施,纳入了六项研究。七个结果的结果集中在(残疾,ADL,体重变化,全因死亡率,步态速度,生活质量,和并发症发生率(不良事件))如下:当“良好状态”定义为mRS评分为0至2时,没有证据表明减少残疾的差异(对于“良好状态”:OR0.97,95%CI0.86至1.10;1个RCT,4023名参与者;低确定性证据)。口服能量和蛋白质补充剂可以改善ADL,如FIM运动评分增加所示,但证据非常不确定(MD8.74,95%CI5.93至11.54;2项随机对照试验,165名参与者;非常低的确定性证据)。口服能量和蛋白质补充剂可能会增加体重,但证据非常不确定(MD0.90,95%CI0.23至1.58;3项RCT,205名参与者;非常低的确定性证据)。没有证据表明在降低全因死亡率方面存在差异(OR0.57,95%CI0.14至2.28;2项随机对照试验,4065名参与者;低确定性证据)。对于步态速度和生活质量,没有确定研究。关于并发症(不良事件)的发生率,没有证据表明感染的发生率有差异,包括肺炎,尿路感染,和败血症(OR0.68,95%CI0.20至2.30;1个RCT,42名参与者;非常低的确定性证据)。与常规治疗相比,干预措施与腹泻发生率增加相关(OR4.29,95%CI1.98至9.28;1RCT,4023名参与者;低确定性证据)和高血糖或低血糖的发生(OR15.6,95%CI4.84至50.23;1个RCT,4023名参与者;低确定性证据)。
    结论:我们不确定营养治疗的效果,包括口服能量和蛋白质补充剂以及本综述中确定的其他补充剂,关于减少中风后患者的残疾和改善ADL。在纳入的研究中,评估了各种营养干预措施的结果。几乎所有研究的样本量都很小。这导致了进行荟萃分析的挑战,并降低了证据的准确性。此外,大多数研究都存在偏见风险,特别是在没有盲目性和不清楚的信息方面。关于不良事件,口服能量和蛋白质补充剂的干预与较高数量的不良事件相关,比如腹泻,高血糖症,和低血糖,与通常的护理相比。然而,证据质量很低。鉴于我们审查中大多数证据的确定性较低,需要进一步的研究。未来的研究应该集中在有针对性的营养干预,以减少残疾和改善ADL的理论基础上,中风后的人,有必要改进方法和报告。
    BACKGROUND: Stroke patients often face disabilities that significantly interfere with their daily lives. Poor nutritional status is a common issue amongst these patients, and malnutrition can severely impact their functional recovery post-stroke. Therefore, nutritional therapy is crucial in managing stroke outcomes. However, its effects on disability, activities of daily living (ADL), and other critical outcomes have not been fully explored.
    OBJECTIVE: To evaluate the effects of nutritional therapy on reducing disability and improving ADL in patients after stroke.
    METHODS: We searched the trial registers of the Cochrane Stroke Group, CENTRAL, MEDLINE (from 1946), Embase (from 1974), CINAHL (from 1982), and AMED (from 1985) to 19 February 2024. We also searched trials and research registries (ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform) and reference lists of articles.
    METHODS: We included randomised controlled trials (RCTs) that compared nutritional therapy with placebo, usual care, or one type of nutritional therapy in people after stroke. Nutritional therapy was defined as the administration of supplemental nutrients, including energy, protein, amino acids, fatty acids, vitamins, and minerals, through oral, enteral, or parenteral methods. As a comparator, one type of nutritional therapy refers to all forms of nutritional therapies, excluding the specific nutritional therapy defined for use in the intervention group.
    METHODS: We used Cochrane\'s Screen4Me workflow to assess the initial search results. Two review authors independently screened references that met the inclusion criteria, extracted data, and assessed the risk of bias and the certainty of the evidence using the GRADE approach. We calculated the mean difference (MD) or standardised mean difference (SMD) for continuous data and the odds ratio (OR) for dichotomous data, with 95% confidence intervals (CIs). We assessed heterogeneity using the I2 statistic. The primary outcomes were disability and ADL. We also assessed gait, nutritional status, all-cause mortality, quality of life, hand and leg muscle strength, cognitive function, physical performance, stroke recurrence, swallowing function, neurological impairment, and the development of complications (adverse events) as secondary outcomes.
    RESULTS: We identified 52 eligible RCTs involving 11,926 participants. Thirty-six studies were conducted in the acute phase, 10 in the subacute phase, three in the acute and subacute phases, and three in the chronic phase. Twenty-three studies included patients with ischaemic stroke, three included patients with haemorrhagic stroke, three included patients with subarachnoid haemorrhage (SAH), and 23 included patients with ischaemic or haemorrhagic stroke including SAH. There were 25 types of nutritional supplements used as an intervention. The number of studies that assessed disability and ADL as outcomes were nine and 17, respectively. For the intervention using oral energy and protein supplements, which was a primary intervention in this review, six studies were included. The results for the seven outcomes focused on (disability, ADL, body weight change, all-cause mortality, gait speed, quality of life, and incidence of complications (adverse events)) were as follows: There was no evidence of a difference in reducing disability when \'good status\' was defined as an mRS score of 0 to 2 (for \'good status\': OR 0.97, 95% CI 0.86 to 1.10; 1 RCT, 4023 participants; low-certainty evidence). Oral energy and protein supplements may improve ADL as indicated by an increase in the FIM motor score, but the evidence is very uncertain (MD 8.74, 95% CI 5.93 to 11.54; 2 RCTs, 165 participants; very low-certainty evidence). Oral energy and protein supplements may increase body weight, but the evidence is very uncertain (MD 0.90, 95% CI 0.23 to 1.58; 3 RCTs, 205 participants; very low-certainty evidence). There was no evidence of a difference in reducing all-cause mortality (OR 0.57, 95% CI 0.14 to 2.28; 2 RCTs, 4065 participants; low-certainty evidence). For gait speed and quality of life, no study was identified. With regard to incidence of complications (adverse events), there was no evidence of a difference in the incidence of infections, including pneumonia, urinary tract infections, and septicaemia (OR 0.68, 95% CI 0.20 to 2.30; 1 RCT, 42 participants; very low-certainty evidence). The intervention was associated with an increased incidence of diarrhoea compared to usual care (OR 4.29, 95% CI 1.98 to 9.28; 1 RCT, 4023 participants; low-certainty evidence) and the occurrence of hyperglycaemia or hypoglycaemia (OR 15.6, 95% CI 4.84 to 50.23; 1 RCT, 4023 participants; low-certainty evidence).
    CONCLUSIONS: We are uncertain about the effect of nutritional therapy, including oral energy and protein supplements and other supplements identified in this review, on reducing disability and improving ADL in people after stroke. Various nutritional interventions were assessed for the outcomes in the included studies, and almost all studies had small sample sizes. This led to challenges in conducting meta-analyses and reduced the precision of the evidence. Moreover, most of the studies had issues with the risk of bias, especially in terms of the absence of blinding and unclear information. Regarding adverse events, the intervention with oral energy and protein supplements was associated with a higher number of adverse events, such as diarrhoea, hyperglycaemia, and hypoglycaemia, compared to usual care. However, the quality of the evidence was low. Given the low certainty of most of the evidence in our review, further research is needed. Future research should focus on targeted nutritional interventions to reduce disability and improve ADL based on a theoretical rationale in people after stroke and there is a need for improved methodology and reporting.
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  • 文章类型: Systematic Review
    背景:经前综合症(PMS)是身体,育龄妇女的心理和社会症状,经前烦躁不安症(PMDD)是一种严重的综合征,以前称为黄体晚期焦虑障碍(LLPDD)。这两种综合征都会在月经前两周(黄体期)引起症状。选择性5-羟色胺再摄取抑制剂(SSRIs)越来越多地用作PMS和PMDD的治疗,在黄体期或连续给药。我们进行了系统审查,以评估SSRIs在PMS和PMDD管理中的积极作用和危害的证据。
    目的:评估SSRIs治疗PMS和PMDD的益处和危害。
    方法:我们搜索了Cochrane妇科和生育力(CGF)对照试验专业注册,中部,MEDLINE,Embase和PsycINFO用于2023年11月的随机对照试验(RCT)。我们检查了相关研究的参考清单,搜索试验登记册,并联系该领域的专家进行任何其他试验.这是上一次于2013年发布的评论的更新。
    方法:我们考虑了前瞻性诊断为PMS的女性的研究,PMDD或LLPDD随机接受SSRIs或安慰剂。
    方法:我们使用标准Cochrane方法。我们使用随机效应模型汇集数据。我们计算了经前症状评分的95%置信区间(CI)的标准化平均差(SMD),使用“治疗后”评分获取连续数据。我们计算了二分结果的95%CI的比值比(OR)。我们按给药类型(黄体期或连续)进行分层分析。我们计算了绝对风险和需要服用SSRIs以引起额外不良事件的女性人数(即治疗额外有害结果所需的人数(NNTH))。我们使用GRADE对主要发现的证据的总体确定性进行了评级。
    结果:我们纳入了34项RCTs。这些研究比较了SSRIs(即氟西汀,帕罗西汀,舍曲林,艾司西酞普兰和西酞普兰)服用安慰剂。SSRIs可能会降低PMS和PMDD女性的总体自我评估的经前症状(SMD-0.57,95%CI-0.72至-0.42;I2=51%;12项研究,1742名参与者;中度确定性证据)。SSRI治疗在连续给药时可能比仅在黄体期给药时更有效(亚组差异P=0.03;黄体期组:SMD-0.39,95%CI-0.58至-0.21;6项研究,687名参与者;中度确定性证据;连续组:SMD-0.69,95%CI-0.88至-0.51;7项研究,1055名参与者;中等确定性证据)。与SSRIs相关的不良反应为恶心(OR3.30,95%CI2.58至4.21;I2=0%;18项研究,3664名妇女),失眠(OR1.99,95%CI1.51至2.63;I2=0%;18项研究,3722名妇女),性功能障碍或性欲下降(OR2.32,95%CI1.57至3.42;I2=0%;14项研究,2781名妇女),疲劳或镇静(OR1.52,95%CI1.05至2.20;I2=0%;10项研究,1230名妇女),头晕或眩晕(OR1.96,95%CI1.36至2.83;I2=0%;13项研究,2633名妇女),震颤(OR5.38,95%CI2.20至13.16;I2=0%;4项研究,1352名妇女),嗜睡和浓度降低(OR3.26,95%CI2.01至5.30;I2=0%;8项研究,2050年妇女),出汗(OR2.17,95%CI1.36至3.47;I2=0%;10项研究,2304名妇女),口干(OR2.70,95%CI1.75至4.17;I2=0%;11项研究,1753名妇女),虚弱或能量下降(OR3.28,95%CI2.16至4.98;I2=0%;7项研究,1704名妇女),腹泻(OR2.06,95%CI1.37至3.08;I2=0%;12项研究,2681名妇女),和便秘(OR2.39,95%CI1.09至5.26;I2=0%;7项研究,1022名妇女)。除嗜睡/浓度降低外,所有不良反应均有中等确定性证据,这是低确定性的证据。总的来说,证据的确定性是中等的。主要弱点是研究方法报告不佳。大多数结果的异质性较低或不存在,尽管在总体自我评估的经前症状分析中存在中等异质性。基于对应答率(纳入研究最多的结果)的荟萃分析,有可疑的发表偏倚。总的来说,68%的研究由制药公司资助。这强调了谨慎解释审查结果的重要性。
    结论:SSRIs可能会减轻患有PMS和PMDD的女性的经前症状,并且与黄体期给药相比,连续服用可能更有效。SSRI治疗可能会增加不良事件的风险,最常见的是恶心,虚弱和嗜睡。
    BACKGROUND: Premenstrual syndrome (PMS) is a combination of physical, psychological and social symptoms in women of reproductive age, and premenstrual dysphoric disorder (PMDD) is a severe type of the syndrome, previously known as late luteal phase dysphoric disorder (LLPDD). Both syndromes cause symptoms during the two weeks leading up to menstruation (the luteal phase). Selective serotonin reuptake inhibitors (SSRIs) are increasingly used as a treatment for PMS and PMDD, either administered in the luteal phase or continuously. We undertook a systematic review to assess the evidence of the positive effects and the harms of SSRIs in the management of PMS and PMDD.
    OBJECTIVE: To evaluate the benefits and harms of SSRIs in treating women diagnosed with PMS and PMDD.
    METHODS: We searched the Cochrane Gynaecology and Fertility (CGF) Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase and PsycINFO for randomised controlled trials (RCTs) in November 2023. We checked reference lists of relevant studies, searched trial registers and contacted experts in the field for any additional trials. This is an update of a review last published in 2013.
    METHODS: We considered studies in which women with a prospective diagnosis of PMS, PMDD or LLPDD were randomised to receive SSRIs or placebo.
    METHODS: We used standard Cochrane methods. We pooled data using a random-effects model. We calculated standardised mean differences (SMDs) with 95% confidence intervals (CIs) for premenstrual symptom scores, using \'post-treatment\' scores for continuous data. We calculated odds ratios (ORs) with 95% CIs for dichotomous outcomes. We stratified analyses by type of administration (luteal phase or continuous). We calculated absolute risks and the number of women who would need to be taking SSRIs in order to cause one additional adverse event (i.e. the number needed to treat for an additional harmful outcome (NNTH)). We rated the overall certainty of the evidence for the main findings using GRADE.
    RESULTS: We included 34 RCTs in the review. The studies compared SSRIs (i.e. fluoxetine, paroxetine, sertraline, escitalopram and citalopram) to placebo. SSRIs probably reduce overall self-rated premenstrual symptoms in women with PMS and PMDD (SMD -0.57, 95% CI -0.72 to -0.42; I2 = 51%; 12 studies, 1742 participants; moderate-certainty evidence). SSRI treatment was probably more effective when administered continuously than when administered only in the luteal phase (P = 0.03 for subgroup difference; luteal phase group: SMD -0.39, 95% CI -0.58 to -0.21; 6 studies, 687 participants; moderate-certainty evidence; continuous group: SMD -0.69, 95% CI -0.88 to -0.51; 7 studies, 1055 participants; moderate-certainty evidence). The adverse effects associated with SSRIs were nausea (OR 3.30, 95% CI 2.58 to 4.21; I2 = 0%; 18 studies, 3664 women), insomnia (OR 1.99, 95% CI 1.51 to 2.63; I2 = 0%; 18 studies, 3722 women), sexual dysfunction or decreased libido (OR 2.32, 95% CI 1.57 to 3.42; I2 = 0%; 14 studies, 2781 women), fatigue or sedation (OR 1.52, 95% CI 1.05 to 2.20; I2 = 0%; 10 studies, 1230 women), dizziness or vertigo (OR 1.96, 95% CI 1.36 to 2.83; I2 = 0%; 13 studies, 2633 women), tremor (OR 5.38, 95% CI 2.20 to 13.16; I2 = 0%; 4 studies, 1352 women), somnolence and decreased concentration (OR 3.26, 95% CI 2.01 to 5.30; I2 = 0%; 8 studies, 2050 women), sweating (OR 2.17, 95% CI 1.36 to 3.47; I2 = 0%; 10 studies, 2304 women), dry mouth (OR 2.70, 95% CI 1.75 to 4.17; I2 = 0%; 11 studies, 1753 women), asthenia or decreased energy (OR 3.28, 95% CI 2.16 to 4.98; I2 = 0%; 7 studies, 1704 women), diarrhoea (OR 2.06, 95% CI 1.37 to 3.08; I2 = 0%; 12 studies, 2681 women), and constipation (OR 2.39, 95% CI 1.09 to 5.26; I2 = 0%; 7 studies, 1022 women). There was moderate-certainty evidence for all adverse effects other than somnolence/decreased concentration, which was low-certainty evidence. Overall, the certainty of the evidence was moderate. The main weakness was poor reporting of study methodology. Heterogeneity was low or absent for most outcomes, although there was moderate heterogeneity in the analysis of overall self-rated premenstrual symptoms. Based on the meta-analysis of response rate (the outcome with the most included studies), there was suspected publication bias. In total, 68% of the included studies were funded by pharmaceutical companies. This stresses the importance of interpreting the review findings with caution.
    CONCLUSIONS: SSRIs probably reduce premenstrual symptoms in women with PMS and PMDD and are probably more effective when taken continuously compared to luteal phase administration. SSRI treatment probably increases the risk of adverse events, with the most common being nausea, asthenia and somnolence.
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  • 文章类型: Journal Article
    背景:系统评价(SR)会定期更新以反映新的证据。然而,更新既耗时又昂贵,因此,理想情况下应该从新的高质量研究中获得信息。这项研究的目的是评估数量的趋势,质量,和最近的证据干预正畸SR的更新。
    方法:从Cochrane数据库中确定了与正畸相关的至少两个版本的SR。数字,偏见的风险,每次更新记录纳入试验的发表年份.进行多元回归以评估影响试验偏倚风险的因素。以及SR内的比例。
    结果:包括45个SR,包括更新。每次审查的试验中位数为3次,并且在随后的版本中有所增加。七篇评论(15.6%)没有证据,和40.74%的更新包括没有新的证据。大多数主要研究被认为是高偏倚风险(57.3%),尽管这在更新中略有减少。在两次更新之间,被认为是低风险的研究比例没有显着改善。临床试验发表年份对偏倚风险没有影响(P=0.349)。然而,纳入系统评价的试验平均年龄显著影响低偏倚风险研究的比例(P=0.039).
    结论:SR经常更新而不包括新的证据。包括在内的新证据通常被认为存在偏见的高风险。应考虑有针对性的策略,以提高资源的有效利用和提高研究质量。
    BACKGROUND: Systematic reviews (SR) are regularly updated to reflect new evidence. However, updates are time-consuming and costly, and therefore should ideally be informed by new high-quality research. The purpose of this study is to assess trends in the quantity, quality, and recency of evidence intervening updates of orthodontic SR.
    METHODS: SR relevant to orthodontics with at least two versions were identified from the Cochrane Database. The number, risk of bias, and year of publication of included trials were recorded for each update. Multivariate regression was conducted to assess factors affecting the risk of bias in trials, and the proportions within SR.
    RESULTS: Forty-five SR inclusive of updates were included. The median number of trials was three per review and this increased across subsequent versions. Seven reviews (15.6%) included no evidence, and 40.74% of updates included no new evidence. Most of the primary research was considered high risk of bias (57.3%), although this was reduced marginally across updates. The proportion of studies considered low risk did not improve significantly between updates. There was no impact of publication year of clinical trials on the risk of bias (P = 0.349). However, average age of trials included in a systematic review significantly affected the proportion of low risk-of-bias studies (P = 0.039).
    CONCLUSIONS: SR are frequently updated without including new evidence. New evidence that is included is commonly deemed to be at high risk of bias. Targeted strategies to improve the efficient use of resources and improve research quality should be considered.
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  • 文章类型: Journal Article
    本文概述了历史,composition,组织,责任,和数据安全监控板(DSMB)的法规要求,特别是关于脊髓损伤临床试验的背景。旨在帮助此类委员会的潜在成员和从事新临床试验设计的人员了解DSMB在维护复杂试验完整性方面的重要作用,促进安全,并对抗潜在的偏见。独立的DSMB通过提供研究监督来帮助保护研究对象,并作为确保临床试验按照现有和适当的标准进行的额外步骤。DSMB必须定期开会,努力评估它收到的所有信息,并及时果断地报告。成员必须在整个研究过程中没有重大的利益冲突,并经过充分的培训和经验,以在小组中发挥作用。DSMB服务可以是宝贵的学习经验,也是参与推进医学和帮助维持和提高研究水平的可喜机会。
    This paper provides an overview of the history, composition, organization, responsibilities, and regulatory requirements of Data Safety Monitoring Boards (DSMB), with particular reference to the context of clinical trials in spinal cord injury. It is intended to help potential members of such boards and those undertaking the design of new clinical trials to understand the important role of the DSMB in safeguarding the integrity of complex trials, promoting safety, and countering potential bias. An independent DSMB helps to protect research subjects by providing study oversight and serves as an additional step to assure that clinical trials are performed to existing and appropriate standards. The DSMB must meet on a regular schedule, diligently evaluate all the information it receives, and report in a timely and decisive manner. Members must be free of significant conflicts of interest throughout the study and be adequately trained and experienced to serve their roles within the group. DSMB service can be a valuable learning experience and a gratifying opportunity to participate in advancing medicine and helping to maintain and improve the standards of research.
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  • 文章类型: Journal Article
    背景:疾病潜伏期定义为从疾病开始到疾病诊断的时间。疾病潜伏期偏倚(DLB)可能出现在流行病学研究,检查潜在的结果,由于疾病开始的确切时间是未知的,可能发生在暴露开始之前,可能导致偏见。虽然DLB可以影响流行病学研究,检查不同类型的慢性疾病(如阿尔茨海默病,癌症等),以前尚未阐明DLB在这些研究中引入偏倚的方式.关于偏见的特定类型的信息,和它们的结构,这可能是DLB的次要原因对研究人员来说至关重要,以便更好地理解和控制DLB。
    方法:在这里,我们描述了DLB可以将偏倚(通过不同的结构)引入流行病学研究以解决潜在结果的四种情况。使用有向无环图(DAG)。我们还讨论了潜在的策略,以更好地理解,在这些研究中检查和控制DLB。
    结论:使用因果图,我们发现疾病潜伏期偏倚可以通过以下方式影响流行病学研究的结果:(i)未测量的混杂因素;(ii)反向因果关系;(iii)选择偏倚;(iv)介体偏倚.
    结论:疾病潜伏期偏倚是一种重要的偏倚,可影响许多针对潜在结局的流行病学研究。因果图可以帮助研究人员更好地识别和控制这种偏见。
    BACKGROUND: Disease latency is defined as the time from disease initiation to disease diagnosis. Disease latency bias (DLB) can arise in epidemiological studies that examine latent outcomes, since the exact timing of the disease inception is unknown and might occur before exposure initiation, potentially leading to bias. Although DLB can affect epidemiological studies that examine different types of chronic disease (e.g. Alzheimer\'s disease, cancer etc), the manner by which DLB can introduce bias into these studies has not been previously elucidated. Information on the specific types of bias, and their structure, that can arise secondary to DLB is critical for researchers, to enable better understanding and control for DLB.
    METHODS: Here we describe four scenarios by which DLB can introduce bias (through different structures) into epidemiological studies that address latent outcomes, using directed acyclic graphs (DAGs). We also discuss potential strategies to better understand, examine and control for DLB in these studies.
    CONCLUSIONS: Using causal diagrams, we show that disease latency bias can affect results of epidemiological studies through: (i) unmeasured confounding; (ii) reverse causality; (iii) selection bias; (iv) bias through a mediator.
    CONCLUSIONS: Disease latency bias is an important bias that can affect a number of epidemiological studies that address latent outcomes. Causal diagrams can assist researchers better identify and control for this bias.
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  • 文章类型: Journal Article
    由于对经济和社会的深远影响,求职面试中的认知偏差研究引起了人们的广泛关注。然而,很少有研究关注在心理学专业考试委员会任职的专家心理学家所表现出的偏见。因此,这项研究对以色列的专业化考试中的偏见进行了全面的检查。研究的另一个目标是评估考试后考生所经历的痛苦程度。对参加临床和教育心理学专业考试的418名心理学家进行了问卷调查。调查结果揭示了几个值得注意的结果。首先,发现了几个偏见,包括种族刻板印象,源于认知负荷的偏见,还有更多.其次,提出认知行为疗法(CBT)病例的考生的失败率较高。第三,在考试失败和个人困扰之间发现了正相关,与临床考生相比,教育考生的这种影响更强.最有趣的发现是所有的偏见,无一例外,发生在临床心理学家中,而教育心理学家没有偏见。这一结果与最初的预期相反。因此,本研究旨在通过阐明这两个学科之间这种差异背后的原因,同时考虑与成人诊断领域的“专业知识”感相关的优势和劣势,从而扩大有关心理偏见和刻板印象的现有知识。
    The study of cognitive biases in job interviews has garnered significant attention due to its far-reaching implications for the economy and society. However, little research has focused on the biases exhibited by expert psychologists serving on psychology specialization examination committees. As such, this study has conducted a comprehensive examination of biases within the specialization exam in Israel. One additional objective of the research is to assess the levels of distress experienced by examinees following the examination. Questionnaires were administered to 418 psychologists participating in the clinical and educational psychology specialization exams. The findings unveiled several noteworthy outcomes. Firstly, several biases were identified, including ethnic stereotypes, biases stemming from cognitive load, and more. Secondly, examinees who presented a cognitive-behavioral therapy (CBT) case experienced a higher failure rate. Thirdly, a positive association was found between exam failure and personal distress and this effect was stronger for educational examinees compared to clinical examinees. The most intriguing discovery was that all biases, without exception, occurred among clinical psychologists, whereas educational psychologists displayed no biases. This outcome contrasted with initial expectations. Consequently, the present study aims to expand the existing knowledge about psychological biases and stereotypes by elucidate the reasons behind this discrepancy between the two disciplines while considering the advantages and disadvantages associated with a sense of \"expertise\" in the realm of adult diagnostics.
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  • 文章类型: Journal Article
    传统的认知与情感分离的观点最近受到质疑。本研究旨在调查情绪效价对心理数线(MNL)上数字表示的准确性和偏倚的影响。该研究包括164名参与者,他们被随机分配到两组,使用匹配的唤醒电影剪辑诱导积极和消极情绪效价。参与者执行了计算机化的数字到位置(CNP)任务,以估计数字在水平线上的位置。结果显示,正价组的参与者表现出向右的偏向,而那些在负价组中表现出相反的模式。对平均绝对误差的分析表明,与正效价组相比,负效价组的错误率更高。此外,MNL估计模式分析表明,两周期循环功率模型(CPM)能最好地解释两组的数据.这些发现表明,情绪效价会影响MNL上数字的空间表示,并影响数值估计的准确性。最后,我们的发现将根据身体特异性和大脑的不对称频率调谐(BAFT)理论进行讨论。这项研究为情绪和数字认知之间的相互作用提供了新的见解。
    The traditional view of cognition as detached from emotions is recently being questioned. This study aimed to investigate the influence of emotional valence on the accuracy and bias in the representation of numbers on the mental number line (MNL). The study included 164 participants who were randomly assigned into two groups with induced positive and negative emotional valence using matched arousal film clips. Participants performed a computerised number-to-position (CNP) task to estimate the position of numbers on a horizontal line. The results showed that participants in the positive valence group exhibited a rightward bias, while those in the negative valence group showed an opposite pattern. The analysis of mean absolute error revealed that the negative valence group had higher error rates compared to the positive valence group. Furthermore, the MNL estimation pattern analysis indicated that a two-cycle cyclic power model (CPM) best explained the data for both groups. These findings suggest that emotional valence influences the spatial representation of numbers on the MNL and affects accuracy in numerical estimations. Our findings are finally discussed in terms of body-specificity and the Brain\'s Asymmetric Frequency Tuning (BAFT) theories. The study provides new insights into the interplay between emotions and numerical cognition.
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  • 文章类型: Journal Article
    研究人员和决策者经常收集和使用所需的生育率指标,但是他们自我报告的性质增加了报告偏见的可能性。在本文中,我们通过比较对直接调查问题和间接问题的回答来测试这种偏见的存在,随机化,在尼日利亚妇女的社会经济多样化样本中,对受访者的保密程度([公式:见正文])。我们发现,当被间接询问时,女性报告的生育偏好更高,但只有当他们的回答给他们完全保密时,当他们的反应对枚举器视而不见时,就不会了。我们的结果表明,意外怀孕的可能性可能比目前认为的要少,而且我们发现的偏见可能会削弱计划生育政策的有效性。最后,我们提出了关于如何减轻报告偏见的未来工作的建议。
    Desired fertility measures are routinely collected and used by researchers and policy makers, but their self-reported nature raises the possibility of reporting bias. In this paper, we test for the presence of such bias by comparing responses to direct survey questions with indirect questions offering a varying, randomized, degree of confidentiality to respondents in a socioeconomically diverse sample of Nigerian women ([Formula: see text]). We find that women report higher fertility preferences when asked indirectly, but only when their responses afford them complete confidentiality, not when their responses are simply blind to the enumerator. Our results suggest that there may be fewer unintended pregnancies than currently thought and that the effectiveness of family planning policy targeting may be weakened by the bias we uncover. We conclude with suggestions for future work on how to mitigate reporting bias.
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