patient-related outcome

  • 文章类型: Randomized Controlled Trial
    背景:光固化树脂广泛用作牙龈屏障以保护牙龈免受牙齿漂白中使用的高浓度过氧化物的影响。屏障品牌对临床结果的影响通常被认为是可以忽略的。然而,关于不同品牌对运营商经验的影响的证据有限,屏障适应,和病人的舒适。
    目的:这项临床试验评估了四个商业牙龈屏障品牌(Opaldam,Topdam,Lysadam,和Maxdam)对操作员的感知,适应质量,和病人的舒适。
    方法:21名本科生使用盲式注射器以随机顺序放置牙龈屏障。障碍物的照片是从正面和切面的角度拍摄的。漂白程序后,操作员使用Likert量表对处理功能和安全性进行评级。两名经验丰富的评估人员以1(完美)至5(不可接受)的等级独立评估了屏障适应质量。记录屏障引起的不适的绝对风险。数据采用Friedman检验和卡方检验(α=0.05)。
    结果:Opaldam和Topdam在大多数处理功能中得分最高,除了移除,这在所有品牌中都是相似的。评估品牌之间的屏障适应质量没有显着差异。不适主要报告在上牙弓,Maxdam的绝对风险最高(该拱门为35%,整体为24%)。
    结论:这项研究表明,牙龈屏障品牌可以影响操作者的感知和患者的舒适度。Opaldam和Topdam是运营商的首选,但所有品牌都表现出相当的适应质量。
    背景:该研究嵌套在巴西临床试验注册中心注册的一项随机临床试验中,识别号为RBR-9gtr9sc。
    BACKGROUND: Light-cured resins are widely used as gingival barriers to protect the gums from highly concentrated peroxides used in tooth bleaching. The impact of barrier brand on clinical outcomes is typically considered negligible. However, there is limited evidence on the effects of different brands on operator experience, barrier adaptation, and patient comfort.
    OBJECTIVE: This clinical trial assessed the impact of four commercial gingival barrier brands (Opaldam, Topdam, Lysadam, and Maxdam) on operator perception, adaptation quality, and patient comfort.
    METHODS: Twenty-one undergraduate students placed gingival barriers in a randomized sequence using blinded syringes. Photographs of the barriers were taken from frontal and incisal perspectives. After bleaching procedures, operators rated handling features and safety using Likert scale forms. Two experienced evaluators independently assessed barrier adaptation quality on a scale from 1 (perfect) to 5 (unacceptable). The absolute risk of barrier-induced discomfort was recorded. Data were analyzed using Friedman and Chi-square tests (α = 0.05).
    RESULTS: Opaldam and Topdam received the highest scores in most handling features, except for removal, which was similar among all brands. No significant difference was observed in barrier adaptation quality between the evaluated brands. Discomforts were mainly reported in the upper dental arch, with Maxdam having the highest absolute risk (35% for this arch and 24% overall).
    CONCLUSIONS: This study suggests that gingival barrier brands can influence operator perception and patient comfort. Opaldam and Topdam were preferred by operators, but all brands demonstrated comparable adaptation quality.
    BACKGROUND: The study was nested in a randomized clinical trial registered in the Brazilian Clinical Trials Registry under identification number RBR-9gtr9sc.
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  • 文章类型: Journal Article
    心肺复苏(CPR)研究传统上侧重于生存。2018年,国际复苏联络委员会(ILCOR)提出了更多以患者为中心的结果。我们的叙述性综述评估了2018年后的临床试验,以确定OHCA研究领域结果指标的趋势。我们从2019年1月1日至2023年9月22日对PubMed数据库进行了搜索。涉及成年人的前瞻性临床试验是合格的。未报告任何患者相关结果或无法获得全文或英语的研究被排除。评估文章的人口统计信息以及主要和次要结果。我们纳入了89项研究进行分析。对于主要结果,31项(35%)研究评估了神经认知功能,和27(30%)使用生存。对于次要结果,神经认知功能出现在20项(22%)研究中,在10项(11%)研究中存在生存率。26项(29%)研究同时使用了生存和神经认知功能。自2018年COSCA指南发布以来,人们越来越关注神经系统结局。尽管生存结果经常被使用,我们观察到以ROSC为主要结局的研究减少的趋势.没有生活质量评估,提示需要进行更多的以患者为中心的研究,以指导心脏骤停治疗.
    Cardiopulmonary resuscitation (CPR) research traditionally focuses on survival. In 2018, the International Liaison Committee on Resuscitation (ILCOR) proposed more patient-centered outcomes. Our narrative review assessed clinical trials after 2018 to identify the trends of outcome metrics in the field OHCA research. We performed a search of the PubMed database from 1 January 2019 to 22 September 2023. Prospective clinical trials involving adult humans were eligible. Studies that did not report any patient-related outcomes or were not available in full-text or English language were excluded. The articles were assessed for demographic information and primary and secondary outcomes. We included 89 studies for analysis. For the primary outcome, 31 (35%) studies assessed neurocognitive functions, and 27 (30%) used survival. For secondary outcomes, neurocognitive function was present in 20 (22%) studies, and survival was present in 10 (11%) studies. Twenty-six (29%) studies used both survival and neurocognitive function. Since the publication of the COSCA guidelines in 2018, there has been an increased focus on neurologic outcomes. Although survival outcomes are used frequently, we observed a trend toward fewer studies with ROSC as a primary outcome. There were no quality-of-life assessments, suggesting a need for more studies with patient-centered outcomes that can inform the guidelines for cardiac-arrest management.
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  • 文章类型: Journal Article
    由于患有癌症的老年人在随机临床试验(RCT)中的代表性不足,对这一人群的治疗决定所依赖的证据有限.用于评估治疗疗效的常用RCT终点通常以肿瘤为中心(例如,无进展生存期)。这些终点可能与更经常出现合并症的老年患者无关。与癌症无关的死亡,和治疗毒性。此外,他们的期望和偏好可能与年轻人不同。DATECAN-ELDERLY计划结合了广泛的专业知识,在老年肿瘤学和临床研究中,对癌症RCT感兴趣,包括老年癌症患者。为了指导研究人员和临床医生协调涉及老年癌症患者的癌症RCT,专家们回顾了相关领域的文献,以评估使用患者报告的结果(PRO)和患者相关的结果,以及与这些领域相关的可用工具。专家小组在评估老年癌症患者的RCT治疗效果时认为相关的领域包括功能自主性,认知,抑郁症和营养这些基于国际社会和监管机构发布的指南,以及建议在RCT中收集的最低数据集,包括患有癌症的老年人。此外,与健康相关的生活质量,患者的症状,小组还考虑了满意度。关于评估这些领域的工具,我们强调每个工具都有自己的优势和局限性,很少有人在患有癌症的老年人中得到验证。因此,需要进一步的研究来验证该特定人群中的这些工具,并定义在该人群中开发RCT时使用的最小临床重要差异。因此,最相关工具的选择应以RCT研究问题为指导,以及工具的特定属性。
    As older adults with cancer are underrepresented in randomized clinical trials (RCT), there is limited evidence on which to rely for treatment decisions for this population. Commonly used RCT endpoints for the assessment of treatment efficacy are more often tumor-centered (e.g., progression-free survival). These endpoints may not be as relevant for the older patients who present more often with comorbidities, non-cancer-related deaths, and treatment toxicity. Moreover, their expectation and preferences are likely to differ from younger adults. The DATECAN-ELDERLY initiative combines a broad expertise, in geriatric oncology and clinical research, with interest in cancer RCT that include older patients with cancer. In order to guide researchers and clinicians coordinating cancer RCT involving older patients with cancer, the experts reviewed the literature on relevant domains to assess using patient-reported outcomes (PRO) and patient-related outcomes, as well as available tools related to these domains. Domains considered relevant by the panel of experts when assessing treatment efficacy in RCT for older patients with cancer included functional autonomy, cognition, depression and nutrition. These were based on published guidelines from international societies and from regulatory authorities as well as minimum datasets recommended to collect in RCT including older adults with cancer. In addition, health-related quality of life, patients\' symptoms, and satisfaction were also considered by the panel. With regards to tools for the assessment of these domains, we highlighted that each tool has its own strengths and limitations, and very few had been validated in older adults with cancer. Further studies are thus needed to validate these tools in this specific population and define the minimum clinically important difference to use when developing RCTs in this population. The selection of the most relevant tool should thus be guided by the RCT research question, together with the specific properties of the tool.
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  • 文章类型: Journal Article
    背景:压力性损伤(PI)通常被认为是可预测和可预防的。因此,为PI预防及其管理提供适当的护理至关重要。患者教育是预防PI国际指南推荐策略的重要组成部分。尽管有证据支持患者教育,关于患者教育对知识的影响的共识,患者参与,伤口愈合进展,生活质量仍然缺乏。
    目的:主要目的是系统地评估有关结构化患者教育对其知识的有效性的现有证据,参与,伤口愈合,和生活质量。
    方法:搜索策略检索了2009年至2021年之间在PubMed上以英文发表的研究,MEDLINE,CINAHL,ProQuest,科克伦图书馆包括18岁及以上的成年参与者。随机对照试验,准实验,和介入研究均纳入本综述.三名独立审稿人评估了研究的方法学质量,在批判性评估之前,使用标准化工具,也就是说,JoannaBriggs研究所随机和非随机研究清单.进行了叙事综合。
    结果:本综述共纳入8项研究(466名参与者)。现有证据表明患者知识有所改善,参与,以及结构化患者教育的生活质量。然而,没有足够的高质量证据来推断对伤口愈合的影响.
    结论:结构化的患者PI教育被认为有助于提高患者的知识,参与,和生活质量。对伤口愈合进展的影响需要更严格的试验。因此,未来的教育干预措施应包括描述患者在促进伤口愈合中的作用的伤口护理组件。结构合理的患者教育计划协议对于确保教育干预在其有效性和可重复性方面是至关重要的。
    BACKGROUND: Pressure injuries (PIs) are generally regarded as predictable and preventable. Therefore, providing appropriate care for PI prevention and its management is vital. Patient education is a significant component of the PI international guideline-recommended strategy in preventing PIs. Despite the availability of evidence supporting patient education, consensus regarding the effect of patient education on knowledge, patient participation, wound healing progress, and quality of life is still lacking.
    OBJECTIVE: The main aim was to systematically evaluate the available evidence regarding the effectiveness of structured patient education on their knowledge, participation, wound healing, and quality of life.
    METHODS: The search strategy retrieved studies published between 2009 and 2021 in English across PubMed, MEDLINE, CINAHL, ProQuest, and Cochrane Library. Adult participants aged 18 years and above were included. Randomized controlled trials, quasi-experimental, and interventional studies were all included in this review. Three independent reviewers assessed the methodological quality of the studies, prior to critical appraisal, using standardized tools, that is, the Joanna Briggs Institute checklist for randomized and non-randomized studies. A narrative synthesis was conducted.
    RESULTS: A total of eight studies (466 participants) were included in this review. Available evidence indicated improved patient knowledge, participation, and quality of life with structured patient education. However, there was insufficient high-quality evidence to conclude the effect on wound healing.
    CONCLUSIONS: Structured patient education for PI was deemed to help improve patients\' knowledge, participation, and quality of life. More rigorous trials are needed for the effect on wound healing progress. Thus, future educational interventions should include wound care components that describe the patient\'s role in promoting wound healing. A well-structured patient education program protocol is crucial to ensure the educational intervention was measurable in its effectiveness and reproducibility.
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  • 文章类型: Journal Article
    背景:压力损伤(PI)相关知识可用作PI教育计划的结果指标。在马来西亚,尚未翻译和验证用于测量PI患者中PI相关知识的量表.
    目的:本研究的目的是跨文化适应,翻译和确定的有效性和可靠性的马来版本的修订-皮肤管理需要评估清单(修订-SMnac)。
    方法:该乐器最初是用英语编写的,并翻译成马来语。内部一致性,构造效度,在评估项目和量表的跨文化等效性和内容效度后,检查了测试-重测信度。通过在170名患有PI的住院患者中施用该仪器来确定构建体有效性。通过由五名伤口护理专家组成的小组的验证进一步确定内容有效性指数(CVI)。仪器的稳定性通过测试-重测模型以两周的间隔确定。
    结果:项目-CVI(I-CVI)的内容有效性>79%,表明所有17个项目都是合适的,而量表-CVI(S-CVI)>0.83表示可接受的量表。克朗巴赫的阿尔法为.994,表明内部一致性良好。重测显示出良好的类内相关系数,ICC=0.955,95%CI[0.992-0.996]。
    结论:经修订的SMnac的马来版本被证明是测量马来西亚讲马来语的患者人群中PI相关知识的有效且可靠的工具。建议使用该工具来衡量未来研究中与PI护理相关的教育计划的有效性。
    BACKGROUND: Pressure injury (PI) related knowledge can be used as an outcome indicator of a PI education program. In Malaysia, no scale has been translated and validated for measuring PI-related knowledge among patients with a PI.
    OBJECTIVE: The purpose of this study was to cross-culturally adapt, translate and determine the validity and reliability of the Malay version of the revised-Skin Management Need Assessment Checklist (revised-SMnac).
    METHODS: The instrument was initially written in English and translated into the Malay language. The internal consistency, construct validity, and test-retest reliability were examined after the item and scale\'s cross-cultural equivalence and content validity were evaluated. Construct validity was determined through the administration of the instrument amongst 170 hospitalised patients with a PI. Content validity index (CVI) was further determined through validation by a panel of five wound care experts. The instrument\'s stability was determined by the test-retest model with a two-week interval.
    RESULTS: The content validity of the item-CVI (I-CVI) was >79%, indicating that all 17-items were appropriate, while the scale-CVI (S-CVI) of >0.83 indicated an acceptable scale. The Cronbach\'s Alpha was .994 indicated good internal consistency. Test-retest showed a good intra-class correlation coefficient, ICC = 0.955 with 95% CI [0.992-0.996].
    CONCLUSIONS: The Malay version of the revised-SMnac demonstrated to be a valid and reliable tool to measure PI-related knowledge among the Malay-speaking patient population in Malaysia. The tool is recommended for use to measure the effectiveness of education programs related to PI care in future studies.
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  • 文章类型: Journal Article
    OBJECTIVE: Different types of chronic middle ear disease (CMED) present with differing severity of single symptoms, such as discharge, vertigo or hearing loss, which impair health-related quality of life (HRQoL). Here, we aimed to (i) investigate characteristics of HRQoL and (ii) evaluate the association between HRQoL and hearing among different types of CMED.
    METHODS: In this prospective longitudinal cohort study, we included adult patients undergoing surgical treatment for CMED. Primary outcomes included HRQoL assessed by the Zurich Chronic Middle Ear Inventory (ZCMEI-21) and hearing assessed by pure-tone audiometry.
    RESULTS: In the included 108 patients (51% females), CMED were chronic otitis media (COM) with (n = 46) or without (n = 22) cholesteatoma, persistent mastoid cavity (with [n = 15] or without [n = 10] recurrent cholesteatoma), revision ossiculoplasty for hearing restoration (n = 14), and postinflammatory meatal fibrosis (n = 1). Preoperatively, the mean ZCMEI-21 score showed statistically significant differences among different types of CMED (p = 0.007) with persistent mastoid cavity without cholesteatoma exhibiting the highest score (34.1, SD 7.7) indicating poor HRQoL. At a mean follow-up period of 183 days, no statistically significant differences in the ZCMEI-21 scores among different types of CMED were observed (p = 0.67).
    CONCLUSIONS: This study objectifies differences in HRQoL among different types of CMED. In patients with indication for functional surgery only, e.g., persistent mastoid cavity without cholesteatoma, the worst HRQoL was observed. Yet, in these types of CMED, HRQoL guides decision for treatment. Moreover, differences in HRQoL among different types of CMED were not closely associated with hearing, but largely depended on other symptoms, such as discharge or vertigo.
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  • 文章类型: Journal Article
    Background and objective: To date, there have only been a few studies on oral health-related quality of life (OHRQoL) of people with Ehlers-Danlos syndromes (EDS) and oral conditions. The aim of this study was, therefore, to analyze the OHRQoL of people with EDS from their own point of view as well as obtain information about their age at the time of the diagnosis, the period of time until diagnosis, and the presence of oral conditions (if any) and their association with oral health quality. Methods: The study was designed as an anonymous questionnaire-based cross-sectional study. We conducted a descriptive analysis of the Oral Health Impact Profile-14 (OHIP-14) scores, age of the participants, age at diagnosis, and the time-period between the first signs of the disease and the diagnosis of EDS. To verify the differences in OHIP-14 scores between patients with and without oral conditions, a Mann-Whitney U test was performed. A multivariate quantile (median) regression analysis was performed to evaluate the effect of different general characteristics (gender, age, and the presence of oral conditions) on the OHIP 14 scores. Furthermore, using a Mann-Whitney U test, the influence of different oral conditions was verified by testing the differences between patients without any oral conditions and patients with a specific diagnosis. Results: A total of 79 evaluable questionnaires from 66 female (83.5%) and 13 male (16.5%) participants were analyzed. On average, after the first condition, it takes 18.36 years before EDS are correctly diagnosed. Oral conditions were described by 69.6% of the participants. The median (interquartile range) OHIP-14 score was eight (ten) points for patients without oral conditions and 19 (15) for patients with oral conditions. The multivariable quantile regression shows a statistical notable association between OHIP-14 score and oral conditions (p < 0.001). OHIP-14 scores for dysgnathia, periodontitis, TMD (Temporomandibular dysfunction), a high-arched palate, malocclusion, and the anomaly of tooth formation were statistical notably different between the participants with and the participants without oral conditions. Conclusions: Long diagnostic pathways seem to be a typical problem in patients with EDS. Oral conditions associated with the underlying disease occurred regularly and showed a negative correlation with OHRQoL.
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  • 文章类型: Journal Article
    UNASSIGNED: Recent studies have shown that assessment of the lateral center-edge angle (LCEA) between 18° and 25° is not sufficient to adequately classify mildly dysplastic hips and that further radiological features should be considered. However, no correlation between different morphologic features and clinical outcomes has been investigated so far.
    UNASSIGNED: To analyze the clinical outcomes of patients with different subtypes of borderline dysplastic hips who underwent arthroscopic surgery.
    UNASSIGNED: Cohort study; Level of evidence, 3.
    UNASSIGNED: We examined patients with an LCEA between 18° and 25° who underwent arthroscopic treatment for femoroacetabular impingement syndrome between January 2015 and December 2016. A hierarchical cluster analysis was performed to identify hip morphologic subtypes according to radiographic parameters, including the LCEA, femoro-epiphyseal acetabular roof (FEAR) index, anterior and posterior wall indices (AWI and PWI), Tönnis angle, alpha angle, and femoral neck-shaft angle. In addition, the International Hip Outcome Tool 12 (iHOT-12) and a visual analog scale (VAS) for pain were applied preoperatively and at follow-up, and the results were compared among the different clusters. Previously reported minimal clinically important difference (MCID) and patient acceptable symptomatic state (PASS) values were used to determine clinically significant improvements.
    UNASSIGNED: A total of 40 patients were identified. Of these, 36 patients were available for evaluation at a mean follow-up of 43.8 months. In total, 4 sex-independent clusters with different morphologic patterns of the hip were identified: cluster 1, unstable anterolateral deficiency (FEAR index >2°, AWI <0.35); cluster 2, stable anterolateral deficiency (FEAR index <2°, AWI <0.35); cluster 3, stable lateral deficiency (FEAR index >2°, normal AWI and PWI); and cluster 4, stable posterolateral deficiency (FEAR index <2°, PWI <0.85). At follow-up, clusters 1, 2, and 3 showed significantly improved iHOT-12 (P < .0001) and VAS pain (P < .0001) scores, and cluster 4 showed no significant improvements. The MCID of 15.2 points was achieved by all patients in clusters 2 and 3, by 63% of patients in cluster 1, and by 23% of patients in cluster 4. Clusters 2 and 3 differed significantly from clusters 1 and 4 (P = .02). A postoperative PASS score of 60 was achieved by all patients in cluster 3, by 86% of patients in cluster 2, by 63% of patients in cluster 1, and by 20% of patients in cluster 4. The differences between the groups were statistically significant (P = .01).
    UNASSIGNED: Arthroscopic surgery yielded good results in the treatment of stable borderline hip dysplasia with anterolateral and lateral deficiency. In contrast, borderline hip dysplasia with acetabular retroversion showed no improvements after arthroscopic therapy. This study underlines the need for an accurate analysis of all possible radiological signs to adequately classify borderline dysplastic hips.
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  • 文章类型: Journal Article
    Background: Ectodermal dysplasia describes a heterogeneous group of hereditary, congenital malformations involving developmental dystrophies of ectodermal structures. The aim of this study was to analyse the oral health-related quality of life (OHRQoL) in people with ectodermal dysplasia and to evaluate the influence of different variables. Methods: The study was designed as an anonymous epidemiological survey study among people with ectodermal dysplasia to evaluate oral symptoms, satisfaction with the health system and their respective OHRQoL using the validated German version of the OHIP-14 (Oral Health Impact Profile) questionnaire. Results: When asked about oral symptoms, 110 of the participants provided responses, of which 109 (99.09%) described oral symptoms. The average age of the female participants at the time of diagnosis was 17.02 years (range: 0 to 48 years), the average age of men was 5.19 years (range: 0 to 43 years). The average OHIP-14 overall score for female participants was 12.23 points (SD: 12.39), for male participants an average OHIP score of 11.79 points was recorded (SD: 11.08 points). Difficulty in finding a dentist (p = 0.001), and the dissatisfaction with the health system (p = 0.007) showed a negative impact on the OHRQoL. Conclusion: People with ectodermal dysplasia rate their OHRQoL worse than is usually prevalent in the normal German population (4.09 points); women are diagnosed with \"ectodermal dysplasia\" later than men. Participants who reported difficulties in finding a dentist for treatment exhibited higher OHIP values. Likewise, dissatisfaction with the health system demonstrated a negative impact on the oral health-related quality of life.
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  • 文章类型: Journal Article
    OBJECTIVE: There is a paucity of literature defining the minimal clinically important difference (MCID) for the Knee Society Scores (KSS) after total knee arthroplasty (TKA), and no data on the substantial clinical benefit (SCB) for KSS have been reported. The purpose of this study was to determine MCID and SCB for the KSS in patients with primary TKA.
    METHODS: The median age of patients was 71.6 (range 50-88) years, and 60.3% were females 507 patients with TKA were prospectively enrolled. Patients completed the KSS before surgery and at second postoperative year. The MCID values of the KSS were estimated using anchor-based method, distribution-based method and receiver operating characteristic (ROC) curve analysis with calculation of the area under curve (AUC). SCB was estimated using ROC.
    RESULTS: The MCID for KSS-knee score was 7.2 points by the anchor-based method, 7.2 by the distribution-based method, and using a ROC analysis the cutoff point was 8.9 points with an AUC of 0.75. For KSS-function score, the MCID values were 9.7, 6.3, and 10.3 (AUC 0.71), respectively. SCB values were 39.7 points (AUC 0.74) for the KSS-knee score, and 38.6 (AUC 0.76) for the KSS-function score. Logistic regression showed age and Charlson index to negatively affect the changes in KSS.
    CONCLUSIONS: Different methods for MCID calculation lead to different results. With the use of ROC curve analysis, patients with an improvement of at least 9 points for KSS-knee and 10 points for KSS-function scores experience a clinically important change, whereas those who have at least an improvement of 40 points for KSS-knee and 39 points for KSS-function scores experience a substantial clinical benefit. These findings can ensure clinical improvement from the patient\'s perspective and also aid in interpreting results from clinical studies.
    METHODS: III.
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