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
    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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  • 文章类型: Journal Article
    Pelvic ring fractures, occurring in elderly patients are a challenging problem. Little known is about the patient-related outcome after these injuries. The primary objective of this study is to evaluate the quality of life after pelvic ring injuries in patients aged over 60 years.
    Patients (≥ 60 years) with pelvic ring fractures treated in our trauma department between 2004 and 2014 were included. Next to patient data, injury-related details as well as treatment details were assessed. After a follow-up of at least two years, the survival rate and the patient-related outcome were evaluated using the SF-36 and the EQ-5D score.
    One hundred ninety-six patients (138 women; 58 men; mean age 75.3 ± 7.8 years) were identified. Ninety-six patients were treated operatively, 100 patients conservatively. The overall complication rate was significantly lower for conservatively compared to operatively treated patients (conservatively 18% vs. operatively 33%; p = 0.014). The total mortality rate over 2 years is 29% with no significant difference of the two-year survival rate (2-year survival rate: operatively 77% vs. non-operatively 65%; p = 0.126). Fifty-five patients completed the SF-36 and EQ-5D score after a mean follow-up of 4.2 ± 2.9 years. The mean physical component score of the SF-36 is 33.6 ± 8.3, and the mean mental component score is 45.3 ± 8.4. The mean EQ-5D VAS reached 62.5 ± 27.9.
    Elderly patients with pelvic ring fractures show a high mortality rate and a limited patient-related outcome. While the complication rate of conservatively treated patients is lower compared to operated patients, the two year survival rate is steady.
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  • 文章类型: Journal Article
    The purpose of the study was to assess patient-related outcomes at short-term follow-up in patients with a proximal tibial fracture.
    One hundred sixteen patients (119 fractures) treated at our institution during 2012 were retrospectively reviewed. Follow-up was 1.6 (SD ± 0.4) years post-injury, including the short musculoskeletal function assessment and visual analog scale for pain and satisfaction. Fractures were classified by the Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association classification and divided in two groups: simple and complex.
    Patients with simple fractures reported lower short musculoskeletal function assessment indices and less pain on visual analog scale than those with complex fractures. No difference was found in short musculoskeletal function assessment between surgically and non-surgically treated patients. Non-surgically treated patients reported less pain and were more satisfied. The overall complication rate was 30 (25%) of 119 fractures, with surgical treatment carrying a 7.0 (95% CI: 1.5-34) odds ratio for local complications.
    This study provides information about realistic prognosis after proximal tibial fractures. The finding that surgically treated patients had similar outcomes to non-surgically treated ones may indicate that surgery improves the prognosis of complex fractures to a level comparable to the prognosis of less severe ones. However, the risk of complications after surgery should guide treatment when surgery is not clearly indicated.
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  • 文章类型: Journal Article
    BACKGROUND: Clinical and radiological outcomes of operatively treated unstable pelvic ring fractures are well documented, whereas little is known about the patient\'s related outcome. The purpose of this study is to evaluate the patient-reported outcome after minimal invasive treatment of pelvic ring fractures using the SF-36 and EQ-5D medical outcome scores.
    METHODS: Patients with unstable pelvic ring fractures treated in our trauma department with a minimal invasive screw-rod system between 01/2004 and 12/2014 were included. Next to patient data (sex, age), injury related details (fracture type, additional injuries, Injury Severity Score (ISS)) as well as operation details (method, time to operation, general complications, adverse events associated with the surgical procedure, revision surgery, fracture reduction) were assessed. The patient related outcome was evaluated using the SF-36 and the EQ-5D score.
    RESULTS: A total of 105 patients (57 men; 48 women; mean age 56 ± 21 years) were identified as candidates for the study. 60 patients completed the SF-36 and EQ-5D score after a mean follow-up of five years (60.5 months (14-142 months)). Of these patients 77% were multiply injured with a mean ISS of 26 ± 19. Within the respondent group 22% showed type B and 78% type C pelvic ring fractures. In 82% the dorsal pelvic ring fracture was stabilized using a minimally invasive transiliac internal fixator, in 18% an iliolumbar fixation was performed respectively. The mean physical component score of the SF-36 was 37.9 ± 12.0, the mean mental component score was 49.8 ± 12.5. The mean EQ-5D VAS reached 70.5 ± 24.4.
    CONCLUSIONS: Patients being multiply injured and treated with minimal invasive treated dorsal pelvic ring fractures were suffering more especially concerning physical domains compared to the healthy reference population. Nevertheless, the overall patient-related outcome is comparable to pelvic ring fractures in general.
    BACKGROUND: Clinical Trial Registry University of Regensburg Z-2017-0878-3 . Registered 22. July 2017. Retrospectively registered.
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