OrderRex clinical user testing: a randomized trial of recommender system decision support on simulated cases

ObjectiveTo assess usability and usefulness of a machine learning-based order recommender system applied to simulated clinical cases.Materials and Methods43 physicians entered orders for 5 simulated clinical cases using a clinical order entry interface with or without access to a previously developed automated order recommender system. Cases were randomly allocated to the recommender system in a 3:2 ratio. A panel of clinicians scored whether the orders placed were clinically appropriate. Our primary outcome included the difference in clinical appropriateness scores. Secondary outcomes included total number of orders, case time, and survey responses.ResultsClinical appropriateness scores per order were comparable for cases randomized to the order recommender system (mean difference -0.11 order per score, 95% CI: [-0.41, 0.20]). Physicians using the recommender placed more orders (median 16 vs 15 orders, incidence rate ratio 1.09, 95%CI: [1.01-1.17]). Case times were comparable with the recommender system. Order suggestions generated from the recommender system were more likely to match physician needs than standard manual search options. Physicians used recommender suggestions in 98% of available cases. Approximately 95% of participants agreed the system would be useful for their workflows.DiscussionUser testing with a simulated electronic medical record interface can assess the value of machine learning and clinical decision support tools for clinician usability and acceptance before live deployments.ConclusionsClinicians can use and accept machine learned clinical order recommendations integrated into an electronic order entry interface in a simulated setting. The clinical appropriateness of orders entered was comparable even when supported by automated recommendations.     

Clinical efficacy and safety of recruitment maneuver in patients with acute respiratory distress syndrome using low tidal volume ventilation: a multicenter randomized controlled clinical trial

Background The recruitment maneuver （RM） has been shown to improve oxygenation in some patients with acute respiratory distress syndrome. But there is a lack of standardization and lack of clinical studies to prove the improvement on clinical outcome. We conducted this study to evaluate the clinical efficacy and safety of the RM in patients with acute respiratory distress syndrome （ARDS） using Iow tidal volume ventilation.Methods We randomly assigned 110 patients with ARDS from 14 Chinese intensive care units （ICUs） at the tertiary teaching hospitals. Patients with PaO2 ≤200 mmHg at FiO2 1.0 and PEEP ≥10 cmH2O were included in the study.Patients were randomized into two groups： control group and RM group. The tidal volume was set to 6-8 mi per kilogram of predicted body weight （PBW） in both groups. RM was performed by continuous positive airway pressure （CPAP） of 40 cmH2O maintained for 40 seconds. RMs was conducted every eight hours for the first five days, or stopped within five days if the patient reached the weaning standard.Results One hundred and ten patients had completed the requirements for the primary study goals, 55 from the RM group and 55 control patients. Baseline characteristics remained similar in the two groups. In the RM group the PaO2/FiO2 was significantly increased compared to baseline at 120 minutes after RM on day one and day two （P=0.007and P=0.001）. There were no significant differences between the RM and control group in hospital mortality （41.8% vs.56.4%, P=0.13）, 28-day mortality （29.1% vs. 43.6%, P=0.11） and ventilator-free days at day 28 （10.8±10.1 vs. 7.4±10.0,P=0.08）. ICU mortality （32.7% vs. 52.7%, P=0.03）, the rate of survival with unassisted breathing for at least 48 consecutive hours at day 28 （58.2% vs. 36.2%, P=0.02）, and nonpulmonary organ failure-free days at day 28 （17.4±11.1vs. 13.0±12.0, P=0.03） favored the RM group. There was no significant difference in mean blood pressure and heart rate before RM and at 30, 60, 120 minutes after RM. There was no incidence of barotraumas.Conclusions RM was safe and useful for improving oxygenation in patients with ARDS who were ventilated with a low tidal volume, with a beneficial impact on their clinical outcome.     

Automation in nursing decision support systems: A systematic review of effects on decision making,care delivery,and patient outcomes

ObjectiveThe study sought to summarize research literature on nursing decision support systems (DSSs ); understand which steps of the nursing care process (NCP) are supported by DSSs, and analyze effects of automated information processing on decision making, care delivery, and patient outcomes.Materials and MethodsWe conducted a systematic review in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. PubMed, CINAHL, Cochrane, Embase, Scopus, and Web of Science were searched from January 2014 to April 2020 for studies focusing on DSSs used exclusively by nurses and their effects. Information about the stages of automation (information acquisition, information analysis, decision and action selection, and action implementation), NCP, and effects was assessed.ResultsOf 1019 articles retrieved, 28 met the inclusion criteria, each studying a unique DSS. Most DSSs were concerned with two NCP steps: assessment (82%) and intervention (86%). In terms of automation, all included DSSs automated information analysis and decision selection. Five DSSs automated information acquisition and only one automated action implementation. Effects on decision making, care delivery, and patient outcome were mixed. DSSs improved compliance with recommendations and reduced decision time, but impacts were not always sustainable. There were improvements in evidence-based practice, but impact on patient outcomes was mixed.ConclusionsCurrent nursing DSSs do not adequately support the NCP and have limited automation. There remain many opportunities to enhance automation, especially at the stage of information acquisition. Further research is needed to understand how automation within the NCP can improve nurses’ decision making, care delivery, and patient outcomes.     

“消疲怡神”配方颗粒干预肝郁脾虚型疲劳性亚健康状态的前瞻性随机双盲安慰剂对照试验

背景：亚健康对人们生活、工作的影响及其高发生率使得对其有效干预措施的需求日益突显,而如何发挥中医药在调治亚健康方面的优势及评价中医药干预亚健康的效果,是今后亚健康干预研究的一个重要研究方向。目的：评价＂消疲怡神＂配方颗粒干预肝郁脾虚型疲劳性亚健康状态的有效性及安全性。设计、场所、受试者和干预措施：采用多中心、随机、双盲、安慰剂对照试验,观测时间为18周,其中干预6周,随访12周。将来自北京小汤山医院、河南中医学院第一附属医院及辽宁中医药大学附属医院的体检中心及门诊的200例肝郁脾虚型疲劳性亚健康状态的受试者随机分为＂消疲怡神＂配方颗粒组（简称消疲怡神组,n=100）和安慰剂组（n=100）,分别给予＂消疲怡神＂配方颗粒和安慰剂干预6周。主要结局指标：运用疲劳量表-14（Fatigue Scale14,FS-14）总分来判断疲劳状况,并进行中医证候（肝郁脾虚证）积分评价。结果：消疲怡神组有3例失访,最后200例进入全分析集（full analysisset,FAS）,197例进入符合方案集＂（per-protocol set,PPS）。消疲怡神组与安慰剂组疲劳状态的疗效（FS-14分值）显示,完全缓解率分别为14.0%和9.0%（FAS）与14.4%和9.0%（PPS）,显效率分别为19.0%和15.0%（FAS）与19.6%和15.0%（PPS）,有效率分别为39.0%和26.0%（FAS）与39.2%和26.0%（PPS）,总有效率分别为72.0%和50.0%（FAS）与73.2%和50.0%（PPS）。Ridit分析显示＂消疲怡神＂配方颗粒改善疲劳状态的疗效优于安慰剂（P〈0.05）。消疲怡神组与安慰剂组肝郁脾虚证候的疗效比较显示,完全缓解率分别为1.0%和0.0%（FAS）与1.0%和0.0%（PPS）,显效率分别为20.0%和7.0%（FAS）与19.6%和7.0%（PPS）,有效率分别为29.0%和24.0%（FAS）与29.9%和24.0%（PPS）,总有效率分别为50.0%和31.0%（FAS）与50.5%和31.0%（PPS）。Ridit分析显示＂消疲怡神＂配方颗粒改善肝郁脾虚证候的疗效优于安慰剂（P〈0.05）。第12周和18周随访表明,消疲怡神组的FS-14分值明显低于安慰剂组。未发现试验药物的不良反应。结论：＂消疲怡神＂配方颗粒治疗肝郁脾虚型疲劳性亚健康状态安全有效。     

Efficacy of immediate instillation combined with regular instillations of pirarubicin for Ta and T1 transitional cell bladder cancer after transurethral resection: a prospective, randomized, multicenter study

Background Immediate intravesical instillation of chemotherapeutic agents after transurethral resection (TUR) of nonmuscle invasive transitional cell bladder cancer has recently been suggested and has ...     

Improving completeness of electronic problem lists through clinical decision support: a randomized, controlled trial

Background

Accurate clinical problem lists are critical for patient care, clinical decision support, population reporting, quality improvement, and research. However, problem lists are often incomplete or out of date.

Objective

To determine whether a clinical alerting system, which uses inference rules to notify providers of undocumented problems, improves problem list documentation.

Study Design and Methods

Inference rules for 17 conditions were constructed and an electronic health record-based intervention was evaluated to improve problem documentation. A cluster randomized trial was conducted of 11 participating clinics affiliated with a large academic medical center, totaling 28 primary care clinical areas, with 14 receiving the intervention and 14 as controls. The intervention was a clinical alert directed to the provider that suggested adding a problem to the electronic problem list based on inference rules. The primary outcome measure was acceptance of the alert. The number of study problems added in each arm as a pre-specified secondary outcome was also assessed. Data were collected during 6-month pre-intervention (11/2009–5/2010) and intervention (5/2010–11/2010) periods.

Results

17 043 alerts were presented, of which 41.1% were accepted. In the intervention arm, providers documented significantly more study problems (adjusted OR=3.4, p<0.001), with an absolute difference of 6277 additional problems. In the intervention group, 70.4% of all study problems were added via the problem list alerts. Significant increases in problem notation were observed for 13 of 17 conditions.

Conclusion

Problem inference alerts significantly increase notation of important patient problems in primary care, which in turn has the potential to facilitate quality improvement.

Trial Registration

ClinicalTrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT01105923","term_id":"NCT01105923"}}NCT01105923.     

Effects of an online personal health record on medication accuracy and safety: a cluster-randomized trial

Objective

To determine the effects of a personal health record (PHR)-linked medications module on medication accuracy and safety.

Design

From September 2005 to March 2007, we conducted an on-treatment sub-study within a cluster-randomized trial involving 11 primary care practices that used the same PHR. Intervention practices received access to a medications module prompting patients to review their documented medications and identify discrepancies, generating ‘eJournals’ that enabled rapid updating of medication lists during subsequent clinical visits.

Measurements

A sample of 267 patients who submitted medications eJournals was contacted by phone 3 weeks after an eligible visit and compared with a matched sample of 274 patients in control practices that received a different PHR-linked intervention. Two blinded physician adjudicators determined unexplained discrepancies between documented and patient-reported medication regimens. The primary outcome was proportion of medications per patient with unexplained discrepancies.

Results

Among 121 046 patients in eligible practices, 3979 participated in the main trial and 541 participated in the sub-study. The proportion of medications per patient with unexplained discrepancies was 42% in the intervention arm and 51% in the control arm (adjusted OR 0.71, 95% CI 0.54 to 0.94, p=0.01). The number of unexplained discrepancies per patient with potential for severe harm was 0.03 in the intervention arm and 0.08 in the control arm (adjusted RR 0.31, 95% CI 0.10 to 0.92, p=0.04).

Conclusions

When used, concordance between documented and patient-reported medication regimens and reduction in potentially harmful medication discrepancies can be improved with a PHR medication review tool linked to the provider''s medical record.

Trial registration number

This study was registered at ClinicalTrials.gov ({"type":"clinical-trial","attrs":{"text":"NCT00251875","term_id":"NCT00251875"}}NCT00251875).     

活血化瘀中药治疗轻中度血管性痴呆的有效性：随机、双盲、安慰剂平行对照试验

背景：血管性痴呆是继阿尔茨海默病后的第二大常见痴呆类型。随着人口的老龄化,其患病率逐步上升。但目前尚无证实有效的药物,因此寻求中医治疗是非常必要的。瘀阻脑络证是血管性痴呆的主要中医证候。目的：观察活血化瘀中药治疗轻中度血管性痴呆的临床疗效及安全性。设计、场所、对象和干预措施：这是一项随机、双盲、安慰剂平行对照临床试验。自2009年3月至2010年12月共纳入48例轻中度血管性痴呆患者,随机分为活血化瘀中药组（n=24）和安慰剂对照组（n=24）,所有患者接受2周的洗脱期,其后分别接受为期12周的活血化瘀中药治疗或安慰剂。安慰剂气味和外观均与活血化瘀中药相同。主要结局指标：主要疗效指标是阿尔茨海默病评估量表（认知部分）（Alzheimer’s Disease Assessment Scalecognitive subscale,ADAS-cog）;次要疗效指标是简易精神状态检查量表（Mini—Mental State Examination,MMSE）和日常生活能力量表（Activities of Daily Living,ADL）。 结果：基线时两组人口学及神经心理学量表得分均无差异。活血化瘀中药组治疗12周后ADAS-cog得分较基线无显著变化（P〉0．05）,安慰剂组12周后ADAS-cog得分较基线显著升高2．35分,两组间ADAS-cog变化值的差异具有统计学意义（P=0．027）。两组间MMSE和ADL得分与基线比较差异无统计学意义。两组间不良反应的发生率均较低,且两组间差异无统计学意义。结论：活血化瘀中药能维持患者认知功能,并且具有良好的安全性和耐受性,其远期疗效及安全性尚需大样本临床研究证实。     

补肾活血颗粒对帕金森病患者运动功能的影响：多中心、随机、双盲、安慰剂对照研究

背景：帕金森病（Parkinson’s disease,PD）以静止性震颤、肌强直、动作迟缓等运动障碍为主要临床表现,目前缺乏有效治疗手段,严重影响患者的生活质量。我们既往运用补肾活血法治疗PD取得较好疗效。目的：评价补肾活血颗粒改善PD患者运动功能的有效性。设计、场所、对象和干预措施：采用多中心、随机双盲、安慰剂对照临床试验方法,共纳入120例PD患者,分别来自解放军总医院、广东省中医院、西安西京医院和唐都医院门诊及部分北京地区的干休所和社区。将其随机分为补肾活血颗粒组和安慰剂组,两组均以西药治疗为基础,补肾活血颗粒组加服补肾活血颗粒,安慰剂组加服安慰剂。由于补肾活血颗粒组有5例脱落,安慰剂组有l例因违反治疗方案而被剔除,还有8例脱落,最终完成治疗观察者共106例,其中治疗组55例,对照组51例,疗程均为3个月。主要结局指标：从运动量表、运动试验及肌张力检测等方面全面评价临床疗效,每个月随访1次。结果：补肾活血颗粒组治疗后不同时间UPDRSⅢ评分、10米折返运动试验中起立时间及静息状态肌张力检测指标与治疗前比较,差异均有统计学意义（P〈0．05,P〈0．01）,且时间因素与处理因素存在交互作用（P〈0．05,P〈0．01）。记时运动试验及10米折返运动试验中折返行走及转弯时间等指标,补肾活血颗粒组治疗后不同时间与治疗前比较,差异均无统计学意义（P〉0．05）,时间因素与处理因素也不存在交互作用（P〉0．05）。与安慰剂相比,补肾活血颗粒降低患者UPDRSⅢ的评分,缩短患者起立时间及改善患者肌张力的疗效更明显。研究过程中未发现明显不良反应。结论：补肾活血颗粒加西药在缓解PD患者运动功能障碍方面的效果优于单用西药治疗。     

补肾化痰祛瘀中药治疗遗忘型轻度认知损害的随机、双盲、平行对照临床研究

背景:阿尔茨海默病(Alzheimer disease,AD)的早期诊断和干预十分重要.作为AD的早期阶段,遗忘型轻度认知损害(amnestic mild cognitive impairment,aMCI)逐渐受到关注.研究表明多奈哌齐可以降低轻度认知损害患者的AD评定量表认知分量表(AD assessment scale-cognitive subscale,ADAS-Cog)得分,改善患者的注意力和反应速度,但是具有一定的副作用,因此,有必要进一步探讨中医药对于aMCI的作用.目的:观察补肾化痰祛瘀中药治疗aMCI的临床疗效和安全性.设计、场所、受试者和干预措施:本研究为随机、双盲、平行对照临床试验.根据随机、双盲的原则,将aMCI患者分为补肾化痰祛瘀中药组和盐酸多奈哌齐组.补肾化痰祛瘀中药组予补肾化痰祛瘀中药颗粒,1袋/次,2次/d;盐酸多奈哌齐组予盐酸多奈哌齐5 mg/d.另外58例患者不接受任何治疗,作为对照.在用药第12周对所有入组的aMCI患者进行随访.主要结局指标:ADAS-Cog和简易精神状态检查表(mini-mental status examination,MMSE)得分.结果:补肾化痰祛瘀中药组和盐酸多奈哌齐组治疗12周后的ADAS-Cog得分较基线均有显著改善(P=0.001,P=0.000),而未治疗组MMSE得分和ADAS-Cog得分较基线无显著变化(P=0.151,P=0.125);中药组与盐酸多奈哌齐组比较,差异无统计学意义(P=0.105),两组患者的ADAS-Cog得分均低于未治疗组(P=0.000,P=0.000).补肾化痰祛瘀中药组治疗12周后的注意力得分较基线显著改善(P=0.015),盐酸多奈哌齐组较基线无改善(P=0.085).盐酸多奈哌齐组在用药过程中出现失眠、多梦5例(20.8％),恶心3例(12.5％),腹泻5例(20.8％),分别显著高于补肾化痰祛瘀中药组(P=0.002,P=0.005,P=0.000).两组药物对于患者的生命体征和实验室检查无显著影响.结论:补肾化痰祛瘀中药和盐酸多奈哌齐治疗12周均可以提高aMCI患者的总体认知功能,两种药物疗效相当.此外,补肾化痰祛瘀中药可以较好地改善患者的注意力以及头痛、四肢发凉、腹胀和大便溏泻等临床症状,而且补肾化痰祛瘀中药用药安全、不良反应少,优于盐酸多奈哌齐.有必要进行进一步的研究以评价中药的远期疗效.     

补肾化痰祛瘀中药治疗遗忘型轻度认知损害的随机、双盲、平行对照临床研究

背景：阿尔茨海默病（Alzheimerdisease,AD）的早期诊断和干预十分重要。作为AD的早期阶段,遗忘型轻度认知损害（amnesticmildcognitiveimpairment,aMCI）逐渐受到关注。研究表明多奈哌齐可以降低轻度认知损害患者的AD评定量表认知分量表（ADassessmentscale-cognitiVesubscale,ADAS—Cog）得分,改善患者的注意力和反应速度,但是具有一定的副作用,因此,有必要进一步探讨中医药对于aMCI的作用。目的：观察补肾化痰祛瘀中药治疗aMCI的临床疗效和安全性。设计、场所、受试者和干预措施：本研究为随机、双盲、平行对照临床试验。根据随机、双盲的原则,将aMCI患者分为补肾化痰祛瘀中药组和盐酸多奈哌齐组。补肾化痰祛瘀中药组予补肾化痰祛瘀中药颗粒,1袋／次,2次／d;盐酸多奈哌齐组予盐酸多奈哌齐5mg／d。另外58例患者不接受任何治疗,作为对照。在用药第12周对所有入组的aMCI患者进行随访。主要结局指标：ADAS—Cog和简易精神状态检查表（mini～mentalstatusexamination,MMSE）得分。结果：补肾化痰祛瘀中药组和盐酸多奈哌齐组治疗12周后的ADAS—Cog得分较基线均有显著改善（P=0．001,P=0．000）,而未治疗组MMSE得分和ADAS—Cog得分较基线无显著变化（P=0．151,P=0．125）;中药组与盐酸多奈哌齐组比较,差异无统计学意义（P=0．105）,两组患者的ADAS-Cog得分均低于未治疗组（P=0．000,P=0．000）。补肾化痰祛瘀中药组治疗12周后的注意力得分较基线显著改善（P=0．015）,盐酸多奈哌齐组较基线无改善（P=0．085）。盐酸多奈哌齐组在用药过程中出现失眠、多梦5例（20．8％）,恶心3例（12．5％）,腹泻5例（20．8％）,分别显著高于补肾化痰祛瘀中药组（P=0．002,P=0．005,P=0．000）。两组药物对于患者的生命体征和实验室检查无显著影响。结论：补肾化痰祛瘀中药和盐酸多奈哌齐治疗12周均可以提高aMCI患者的总体认知功能,两种药物疗效相当。此外,补肾化痰祛瘀中药可以较好地改善患者的注意力以及头痛、四肢发凉、腹胀和大便溏泻等临床症状,而且补肾化痰祛瘀中药用药安全、不良反应少,优于盐酸多奈哌齐。有必要进行进一步的研究以评价中药的远期疗效。     

Point-of-care clinical documentation: assessment of a bladder cancer informatics tool (eCancerCareBladder): a randomized controlled study of efficacy,efficiency and user friendliness compared with standard electronic medical records

Objective

To compare the use of structured reporting software and the standard electronic medical records (EMR) in the management of patients with bladder cancer. The use of a human factors laboratory to study management of disease using simulated clinical scenarios was also assessed.

Design

eCancerCare^Bladder and the EMR were used to retrieve data and produce clinical reports. Twelve participants (four attending staff, four fellows, and four residents) used either eCancerCare^Bladder or the EMR in two clinical scenarios simulating cystoscopy surveillance visits for bladder cancer follow-up.

Measurements

Time to retrieve and quality of review of the patient history; time to produce and completeness of a cystoscopy report. Finally, participants provided a global assessment of their computer literacy, familiarity with the two systems, and system preference.

Results

eCancerCare^Bladder was faster for data retrieval (scenario 1: 146 s vs 245 s, p=0.019; scenario 2: 306 vs 415 s, NS), but non-significantly slower to generate a clinical report. The quality of the report was better in the eCancerCare^Bladder system (scenario 1: p<0.001; scenario 2: p=0.11). User satisfaction was higher with the eCancerCare^Bladder system, and 11/12 participants preferred to use this system.

Limitations

The small sample size affected the power of our study to detect differences.

Conclusions

Use of a specific data management tool does not appear to significantly reduce user time, but the results suggest improvement in the level of care and documentation and preference by users. Also, the use of simulated scenarios in a laboratory setting appears to be a valid method for comparing the usability of clinical software.