Long‐term quality of life after pregnancy‐related deep vein thrombosis and the influence of socioeconomic factors and comorbidity

Summary. Background: Little is known about the long‐term impact of pregnancy‐related deep vein thrombosis (DVT) of the lower limbs. Objectives: To evaluate the long‐term consequences of pregnancy‐related DVT by assessment of self‐reported, disease‐specific quality of life (QOL) and symptom severity using the Venous Insufficiency Epidemiological and Economic Study (VEINES)‐QOL/Sym questionnaire, and to investigate the influence of socioeconomic factors and comorbidity. Patients/Methods: In this cross‐sectional case–control study, 313 women with validated pregnancy‐related DVT and 353 controls completed a comprehensive questionnaire, including the disease‐specific VEINES‐QOL/Sym questionnaire. After exclusion of DVT outside the lower limbs and missing scores, the study population comprised 208 patients and 347 controls. A VEINES‐QOL/Sym score < the 25th percentile was defined as a clinically relevant reduced outcome compared with scores ≥ the 50th percentile. Predictors for low scores were identified in multivariate logistic regression models. Results: Cases reported lower mean VEINES‐QOL/Sym scores than controls, 45.6/45.4 vs. 52.8/52.7, respectively (P < 0.001), and QOL among cases was still reduced compared with controls when adjusted for possible confounders. Low education was an independent predictor for both low VEINES‐QOL and VEINES‐Sym scores, and in addition being married/cohabitating predicted low VEINES‐Sym scores. Conclusions: Long‐term QOL and symptom scores as assessed with the VEINES‐QOL/Sym questionnaire were lower in women with previous pregnancy‐related DVT than in controls, and also when adjusted for possible confounders. By logistic regression, low education was an independent predictor for low scores. This supports the use of the VEINES‐QOL/Sym questionnaire in studies on pregnancy‐related DVT.     

Validation of the Korean language version of the incontinence‐quality of life scale

The purpose of this study is to determine the reliability and validity of the translated Korean version of the incontinence‐quality of life (I‐QOL) in a sample of community‐dwelling Korean American women with urinary incontinence in the USA. A survey design was used and a convenience sampling method of 176 Korean American women who reported having urinary incontinence symptoms was used. Translation–back translation procedures were used to translate the English version of the I‐QOL into Korean version. Reliability of the Korean I‐QOL questionnaire was demonstrated by Cronbach's α coefficients. Pearson's correlations of an item with its own scale and other scales were calculated to evaluate item‐convergent and item‐discriminant validity. Confirmatory factor analysis was performed to examine the underlying factor structure of the Korean version of the I‐QOL. Cronbach's α coefficient for all three subscales was greater than 0·70. The results of item‐convergent validity indicated that each item was strongly correlated with the originally belonged subscale. Item‐discriminant validity was evidenced by all lower correlations of an item to the other subscales than that of own subscale. Three factors were extracted from I‐QOL, accounting for 67·37% of the variance. The findings supported the reliability and validity of Korean version of I‐QOL questionnaire. It would be considered as a valuable instrument to assess the different aspects of health‐related quality of life in incontinence patients and recommended for use in clinical research.     

The Pain Self‐Efficacy Questionnaire: Cross‐Cultural Adaptation into Italian and Assessment of Its Measurement Properties

The Pain Self‐Efficacy Questionnaire (PSEQ) is a patient self‐reported measurement instrument that evaluates pain self‐efficacy beliefs in patients with chronic pain. The measurement properties of the PSEQ have been tested in its original and translated versions, showing satisfactory results for validity and reliability. The aims of this study were 2 fold as follows: (1) to translate the PSEQ into Italian through a process of cross‐cultural adaptation, (2) to test the measurement properties of the Italian PSEQ (PSEQ‐I). The cross‐cultural adaptation was completed in 5 months without omitting any item of the original PSEQ. Measurement properties were tested in 165 patients with chronic low back pain (CLBP) (65% women, mean age 49.9 years). Factor analysis confirmed the one‐factor structure of the questionnaire. Internal consistency (Cronbach's α = 0.94) and test–retest reliability (ICC_agreement = 0.82) of the PSEQ‐I showed good results. The smallest detectable change was equal to 15.69 scale points. The PSEQ‐I displayed a high construct validity by meeting more than 75% of a priori hypotheses on correlations with measurement instruments assessing pain intensity, disability, anxiety, depression, pain catastrophizing, fear of movement, and coping strategies. Additionally, the PSEQ‐I differentiated patients taking pain medication or not. The results of this study suggest that the PSEQ‐I can be used as a valid and reliable tool in Italian patients with CLBP.     

Linguistic validation of the N‐QOL (ICIQ), OAB‐q (ICIQ), PPBC,OAB‐S and ICIQ‐MLUTSsex questionnaires in 16 languages

Objective: Overactive bladder (OAB) is a highly prevalent condition with a negative impact on both health‐related quality of life and sexual functioning. We aimed to create and validate conceptually equivalent tools to assess OAB for use in diverse cultural and linguistic settings. Research Design and Methods: To evaluate the linguistic validity of harmonised translations of the Nocturia Quality of Life (N‐QOL) questionnaire, Overactive Bladder Questionnaire (OAB‐q) family, Patient Perception of Bladder Condition (PPBC) questionnaire, Overactive Bladder Satisfaction Questionnaire (OAB‐S) and International Consultation on Incontinence Questionnaire (ICIQ) Male Sexual Matters associated with Lower Urinary Tract Symptoms Questionnaire (ICIQ‐MLUTSsex), bilingual (target language and English) interviewers cognitively debriefed subjects to assess their ability to paraphrase and understand the instructions, questions and responses within each questionnaire. Results: Overall item comprehension rates were 96% for the N‐QOL, 98.9% for the OAB‐q, 92% for the PPBC, 98.5% for the OAB‐S and 94.3% for the ICIQ‐MLUTSsex. Discussion: We found that the translations were well‐understood by subjects, although a number of minor changes were made to the N‐QOL, OAB‐q, OAB‐S and ICIQ‐MLUTSsex translations in an effort to improve clarity and cultural appropriateness. In a few instances, the majority of subjects in a language were unable to paraphrase a specific term or phrase prior to the revisions. In several cases, problems arose from the wording of the question in the source language. Conclusions: The translated instruments in this study demonstrated a high level of overall linguistic validity.     

Determinants of health-related quality of life during the 2 years following deep vein thrombosis

Summary. Background/objectives: We prospectively measured change in quality of life (QOL) during the 2 years after a diagnosis of deep vein thrombosis (DVT) and evaluated determinants of QOL, including development of the post‐thrombotic syndrome (PTS). Patients/methods: Consecutive patients with acute DVT were recruited from 2001 to 2004 at eight hospitals in Canada. At study visits at baseline, and 1, 4, 8, 12 and 24 months, clinical data were collected, standardized PTS assessments were performed, and QOL questionnaires were self‐completed. Generic QOL was measured using the Short‐Form Health Survey‐36 (SF‐36) questionnaire. Venous disease‐specific QOL was measured using the Venous Insufficiency Epidemiological and Economic Study (VEINES)‐QOL/Sym questionnaire. The change in QOL scores over a 2‐year follow‐up was assessed. The influence of PTS and other characteristics on QOL at 2 years was evaluated using multivariable regression analyses. Results: Among the 387 patients recruited, the average age was 56 years, two‐thirds were outpatients, and 60% had proximal DVT. The cumulative incidence of PTS was 47%. On average, QOL scores improved during follow‐up. However, patients who developed PTS had lower scores at all visits and significantly less improvement in QOL over time (P‐values for PTS*time interaction were 0.001, 0.012, 0.014 and 0.006 for PCS, MCS, VEINES‐QOL and VEINES‐Sym). Multivariable regression analyses showed that PTS (P < 0.0001), age (P = 0.0009), proximal DVT (P = 0.01) and inpatient status (P = 0.04) independently predicted 2‐year SF‐36 PCS scores. PTS alone independently predicted 2‐year VEINES‐QOL (P < 0.0001) and VEINES‐Sym (P < 0.0001) scores. Conclusions: Development of PTS is the principal determinant of health‐related QOL 2 years after DVT. Our study provides prognostic information on patient‐reported outcomes after DVT and emphasizes the need for effective prevention and treatment of the PTS.     

Psychometric Properties of the Portuguese Version of the Quality of Life Questionnaire (QOL‐Q)

Background This study analyzes the psychometric properties of the Portuguese version of the Quality of Life Questionnaire (QOL‐Q; Quality of Life Questionnaire Manual – 1993 Manual and 2004 Revision. 2004, IDS Publishing Company, Worthington, OH; Schalock & Keith 2004). Method The analysis of the factorial structure was carried out on a sample of 304 adults with intellectual disabilities, through the use of confirmatory (CFA) and exploratory (EFA) factor analysis. The relationships of the QOL‐Q with life satisfaction and self‐concept measures were determined in groups composed of respectively 72 and 78 adults with intellectual disabilities. Results Confirmatory factorial analysis indicated a poor adjustment of the original factor structure to the Portuguese data. EFA indicated the existence of four factors, which include 30 items, and that were also supported by CFA. The total score of the QOL‐Q revealed a reduced correlation with life satisfaction, and a moderate correlation with the self‐concept. Conclusions The Portuguese version of the QOL‐Q shows satisfactory psychometric properties, but also some limitations.     

Psychometric properties of the Norwegian Person‐centred Climate Questionnaire from a nursing home context

Background: The physical and psychosocial environments in nursing homes influence the residents’ everyday life as well as their well‐being and thriving. The staff’s perceptions of and relationships with the residents are crucially important to quality care. Quality care is described often as person‐centred. Few measurement tools exist that focus on person‐centred care in nursing homes. Objective: The aim of this study was to evaluate the psychometric properties of the Norwegian version of the Person‐centred Climate Questionnaire–Staff version (PCQ‐S). Design: This study had a cross‐sectional survey design. Participants and Settings: Two hundred and nine healthcare and support staff in five nursing homes in the eastern part of Norway. Methods: The Swedish PCQ‐S was translated into Norwegian with forward and backward translation. The relevance of the items included in the questionnaire was assessed by an expert panel of 10 nursing home care staff, because the questionnaire has not been used in this context previously. A psychometric evaluation using statistical estimates of validity and reliability was performed. The discriminatory capacity of the questionnaire was also tested. Results: The content validity index was satisfactory (0.78). The PCQ‐S showed high internal consistency reliability in that Cronbach’s α was satisfactory for the total scale (0.92) and the three subscales (0.81, 0.89 and 0.87). The test–retest reliability was also satisfactory as evident from a Spearman’s correlation coefficient of 0.76 (p < 0.01) between the total PCQ scores at test and retest. The Norwegian version retained the original factor structure of the Swedish version. Conclusion: As the psychometric evaluation showed satisfactory validity and reliability scores, this study supports the Norwegian version of the PCQ‐S when applied to a sample of nursing home staff.     

Fully Automated Dual‐Snake Formulation for Carotid Intima‐Media Thickness Measurement

Automated computer‐aided detection systems for measurement of the carotid intima‐media thickness (IMT) are becoming popular. These systems yield lumen‐intima (LI) and media‐adventitia (MA) borders. In this work, we developed and validated a novel and patented completely automated IMT measurement system called carotid measurement using dual snakes (CMUDS): a class of AtheroEdge system (Global Biomedical Technologies, Inc, Roseville, CA). CMUDS is modeled as a dual parametric system corresponding to LI and MA borders with initialization from the far adventitia layer. The novelty of CMUDS is the first‐order absolute moment–based external energy, which provides stable deformation. The dual snakes evolve simultaneously and are forced to maintain a regularized distance to prevent collapsing or bleeding. Two independent readers manually traced the LI/MA boundaries of a multi‐institutional, multi‐ethnic, and multi‐scanner database of 665 longitudinal images for performance evaluation. CMUDS was also benchmarked against a previously developed automated technique. CMUDS correctly processed 660 images (99.2% success). The differences between the CMUDS and two manual IMT measurements (mean ± SD) were 0.013 ± 0.216 and ?0.021 ± 0.197 mm, respectively. The corresponding figures of merit for CMUDS compared to reader tracings were 98.4% and 97.5%. Compared to the previous technique (IMT differences, 0.022 ± 0.276 and ?0.012 ± 0.266 mm), CMUDS improved accuracy (Wilcoxon P < 0.009) and variability (Fisher P < 10^?8). Among different resolution images from original equipment manufacturer ultrasound scanners, CMUDS performed best with high‐resolution images corresponding to 0.0789 mm/pixel. Accuracy in IMT measurement with the proposed automated CMUDS technique makes this system adaptable to large multi‐center studies, in which such an IMT measurement system would be very useful tool.     

Quantification of Ultrasound Correlation‐Based Flow Velocity Mapping and Edge Velocity Gradient Measurement

This study investigated the use of ultrasound speckle decorrelation‐ and correlation‐based lateral speckle‐tracking methods for transverse and longitudinal blood velocity profile measurement, respectively. By studying the blood velocity gradient at the vessel wall, vascular wall shear stress, which is important in vascular physiology as well as the pathophysiologic mechanisms of vascular diseases, can be obtained. Decorrelation‐based blood velocity profile measurement transverse to the flow direction is a novel approach, which provides advantages for vascular wall shear stress measurement over longitudinal blood velocity measurement methods. Blood flow velocity profiles are obtained from measurements of frame‐to‐frame decorrelation. In this research, both decorrelation and lateral speckle‐tracking flow estimation methods were compared with Poiseuille theory over physiologic flows ranging from 50 to 1000 mm/s. The decorrelation flow velocity measurement method demonstrated more accurate prediction of the flow velocity gradient at the wall edge than the correlation‐based lateral speckle‐tracking method. The novelty of this study is that speckle decorrelation‐based flow velocity measurements determine the blood velocity across a vessel. In addition, speckle decor‐relation‐based flow velocity measurements have higher axial spatial resolution than Doppler ultrasound measurements to enable more accurate measurement of blood velocity near a vessel wall and determine the physiologically important wall shear.     

Measuring the Pain Area: An Intra‐ and Inter‐Rater Reliability Study Using Image Analysis Software

Pain drawings have frequently been used for clinical information and research. The aim of this study was to investigate intra‐ and inter‐rater reliability of area measurements performed on pain drawings. Our secondary objective was to verify the reliability when using computers with different screen sizes, both with and without mouse hardware. Pain drawings were completed by patients with chronic neck pain or neck–shoulder–arm pain. Four independent examiners participated in the study. Examiners A and B used the same computer with a 16‐inch screen and wired mouse hardware. Examiner C used a notebook with a 16‐inch screen and no mouse hardware, and Examiner D used a computer with an 11.6‐inch screen and a wireless mouse. Image measurements were obtained using GIMP and NIH ImageJ computer programs. The length of all the images was measured using GIMP software to a set scale in ImageJ. Thus, each marked area was encircled and the total surface area (cm²) was calculated for each pain drawing measurement. A total of 117 areas were identified and 52 pain drawings were analyzed. The intrarater reliability between all examiners was high (ICC = 0.989). The inter‐rater reliability was also high. No significant differences were observed when using different screen sizes or when using or not using the mouse hardware. This suggests that the precision of these measurements is acceptable for the use of this method as a measurement tool in clinical practice and research.     

Fixed‐dose combination ezetimibe+atorvastatin lowers LDL‐C equivalent to co‐administered components in randomized trials: use of a dose–response model

Co‐administration of ezetimibe with atorvastatin is a generally well‐tolerated treatment option that reduces LDL‐C levels and improves other lipids with greater efficacy than doubling the atorvastatin dose. The objective of the study was to demonstrate the equivalent lipid‐modifying efficacy of fixed‐dose combination (FDC) ezetimibe/atorvastatin compared with the component agents co‐administered individually in support of regulatory filing. Two randomized, 6‐week, double‐blind cross‐over trials compared the lipid‐modifying efficacy of ezetimibe/atorvastatin 10/20 mg (n = 353) or 10/40 mg (n = 280) vs. separate co‐administration of ezetimibe 10 mg plus atorvastatin 20 mg (n = 346) or 40 mg (n = 280), respectively, in hypercholesterolemic patients. Percent changes from baseline in LDL‐C (primary endpoint) and other lipids (secondary endpoints) were assessed by analysis of covariance; triglycerides were evaluated by longitudinal‐data analysis. Expected differences between FDC and the corresponding co‐administered doses were predicted from a dose–response relationship model; sample size was estimated given the expected difference and equivalence margins (±4%). LDL‐C‐lowering equivalence was based on 97.5% expanded confidence intervals (CI) for the difference contained within the margins; equivalence margins for other lipids were not prespecified. Ezetimibe/atorvastatin FDC 10/20 mg was equivalent to co‐administered ezetimibe+atorvastatin 20 mg in reducing LDL‐C levels (54.0% vs. 53.8%) as was FDC 10/40 mg and ezetimibe+atorvastatin 40 mg (58.9% vs. 58.7%), as predicted by the model. Changes in other lipids were consistent with equivalence (97.5% expanded CIs <±3%, included 0); triglyceride changes varied more. All treatments were generally well tolerated. Hypercholesterolemic patients administered ezetimibe/atorvastatin 10/20 and 10/40 mg FDC had equivalent LDL‐C lowering. This FDC formulation proved to be an efficacious and generally well‐tolerated lipid‐lowering therapy.     

Hospice family caregivers’ quality of life

Aims and objectives. To study quality of life (QOL) and its important correlates among family caregivers of terminally ill patients receiving in‐home hospice care. Background. Caregiver QOL has been identified as a core outcome variable in studies of dying patients and their families, but few studies have assessed QOL among caregivers of patients with terminal illness, particularly those in hospice care. Design. For this cross‐sectional correlational study, 60 caregivers were recruited from two local in‐home hospice programmes in the Midwestern United States. Methods. Self‐report data were provided by caregivers using the Caregiver Quality of Life Index – Cancer, Spiritual Well‐Being Scale, American Pain Society Patient Outcomes Questionnaire, Eastern Cooperative Oncology Group Performance Status Rating and Medical Outcome Study Social Support Survey to measure their QOL, spirituality, health status and social support. Results. Caregivers’ educational status, physical health status, spirituality and qualitative and quantitative social support, as a set, explained 42% of the variance in their QOL. Caregivers with higher education, better physical health status, greater spirituality and more qualitative and quantitative social support, had a significantly better QOL. Conclusions. QOL for this sample of hospice caregivers was significantly predicted only by physical health status and spirituality, likely because of collinearity among the independent variables. Additional research is needed to explore the factors that sustain or promote caregivers’ QOL over time. Relevance to clinical practice. In the delivery of hospice services, the family caregiver is both a vital member of the health care team and a recipient of care. Health care providers should therefore pay more attention to the health status and spirituality of major caregivers, thus helping them maintain and improve their QOL.     

Psychometric properties of the Dutch version of the Attitude Towards Deliberate Self‐Harm Questionnaire

The attitude of nurses and treatment staff is crucial in the treatment of patients who self‐harm. However, many patients experience that attitude as negative. The aim of this study was to investigate the psychometric properties of the Dutch version of the Attitude Towards Deliberate Self‐Harm Questionnaire. A total of 261 questionnaires were used to measure validity and reliability. Sensitivity to change was measured using a post‐test measurement (n = 171) and a subgroup of 78 participants were given the questionnaire twice for test–retest measurement. Factor analysis revealed four factors explaining 33% of the variance. Cronbach's alpha values ranged 0.585–0.809, with 0.637 for the total scale. Intraclass correlation coefficient was assessed in order to estimate test–retest reliability, revealing the questionnaire was stable over time; the exception was factor 3, which had a value of 0.63. Sensitivity to change was found for the total score, factor one and two, and for three of the five items of factor three. We conclude that the Dutch version of the Attitude Towards Deliberate Self‐Harm Questionnaire possesses adequate psychometric properties and is potentially an acceptable instrument for measuring the attitude of nurses and health‐care staff towards patients who self‐harm in Dutch‐speaking countries.     

苏州市老年人生活信心和社会支持情况对生活质量的影响

国内外不同的生活质量表对社会支持和心理两状态以及相关因素对其生活质量的影响是否有评价分析的差异?目的了解苏州市老年人群生活质量的现状和生活信心、社会支持情况;探讨老年人生活信心与社会支持情况对其生活质量的影响.设计随机抽样的人群横断面调查.地点、对象和方法选择苏州市医院、学校、工厂的离退休人员及部分苏州干休所的离退休军人共167名,男86名,女81名为研究对象.采用社会支持评定量表(social support review questionnaire,SSRS)、费城老年中心信心量表(Philadelphia geriatric center morale scale,PGC)、简明健康测量量表(medical outcomes study 36-item short-form health survey scale,MOS SF-36)和老年人生活质量调查表对苏州市167名离退休人员进行自评调查.主要观察指标苏州市167名离退休人员SSRS,PGC,MOS SF-36和老年人生活质量调查表评分结果.结果该老年人群生活信心评分为(17.74±3.76)、社会支持总分(37.72±7.48),高于中国人正常值,生活质量平均分值为(28.95±3.05),属于较好水平.无论使用MOS SF-36量表还是用老年人生活质量调查表测出的老年人生活质量均与其生活信心呈正相关(P＜0.01),除老年人生活质量调查表的经济收入与生活信心毫不相关,居住条件和营养状况均与客观支持不相关外,其余各方面均显著相关(P＜0.05).同时用MOS SF-36量表测出的生活质量中仅活力和精神健康与该老年人群的社会支持情况的主观支持相关(P＜0.05),其余均与社会支持情况不相关.老年人生活质量调查表测出的生活质量总分和家庭和睦、社会交往、生活满意度与主观支持显著相关(P＜0.01);家庭和睦、居住条件和生活满意度与客观支持显著相关(P＜0.05);心理卫生与支持利用度显著相关(P＜0.05).结论生活质量随着生活信心和社会支持的升高而升高.采用MOSSF-36量表以及SSRS与PGC调查表测量,生活质量与生活信心的联系均呈正相关;但是对社会支持,尤其是主观支持方面,老年人生活质量调查表可能更敏感、更明显.     

A comparative trial of paper-and-pencil versus computer administration of the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire

BACKGROUND: Although most health-related quality of life questionnaires are self-administered by means of paper and pencil, new technologies for automated computer administration are becoming more readily available. Novel methods of instrument administration must be assessed for score equivalence in addition to consistency in reliability and validity. OBJECTIVES: The present study compared the psychometric characteristics (score equivalence and structure, internal consistency, and reproducibility reliability and construct validity) of the Quality of Life in Reflux And Dyspepsia (QOLRAD) questionnaire when self-administered by means of paper and pencil versus touch-screen computer. The influence of age, education, and prior experience with computers on score equivalence was also examined. RESEARCH DESIGN: This crossover trial randomized 134 patients with gastroesophageal reflux disease to 1 of 2 groups: paper-and-pencil questionnaire administration followed by computer administration or computer administration followed by use of paper and pencil. To minimize learning effects and respondent fatigue, administrations were scheduled 3 days apart. A random sample of 32 patients participated in a 1-week reproducibility evaluation of the computer-administered QOLRAD. RESULTS: QOLRAD scores were equivalent across the 2 methods of administration regardless of subject age, education, and prior computer use. Internal consistency levels were very high (alpha = 0.93-0.99). Interscale correlations were strong and generally consistent across methods (r = 0.7-0.87). Correlations between the QOLRAD and Short Form 36 (SF-36) were high, with no significant differences by method. Test-retest reliability of the computer-administered QOLRAD was also very high (ICC = 0.93-0.96). CONCLUSIONS: Results of the present study suggest that the QOLRAD is reliable and valid when self-administered by means of computer touch-screen or paper and pencil.     

Additive manufacturing of poly[(R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate] scaffolds for engineered bone development

A wide range of poly(hydroxyalkanoate)s (PHAs), a class of biodegradable polyesters produced by various bacteria grown under unbalanced conditions, have been proposed for the fabrication of tissue‐engineering scaffolds. In this study, the manufacture of poly[(R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate] (or PHBHHx) scaffolds, by means of an additive manufacturing technique based on a computer‐controlled wet‐spinning system, was investigated. By optimizing the processing parameters, three‐dimensional scaffolds with different internal architectures were fabricated, based on a layer‐by‐layer approach. The resulting scaffolds were characterized by scanning electron microscopy, which showed good control over the fibre alignment and a fully interconnected porous network, with porosity in the range 79–88%, fibre diameter 47–76 µm and pore size 123–789 µm. Moreover, the resulting fibres presented an internal porosity connected to the external fibre surface as a consequence of the phase‐inversion process governing the solidification of the polymer solution. Scaffold compressive modulus and yield stress and strain could be varied in a certain range by changing the architectural parameters. Cell‐culture experiments employing the MC3T3‐E1 murine pre‐osteoblast cell line showed good cell proliferation after 21 days of culture. The PHBHHx scaffolds demonstrated promising results in terms of cell differentiation towards an osteoblast phenotype. Copyright © 2014 John Wiley & Sons, Ltd.     

Dynamic changes in 1H‐MR relaxometric properties of cell‐internalized paramagnetic liposomes,as studied over a five‐day period

Molecular imaging based on MRI requires the use of amplification strategies in order to achieve sufficient sensitivity for the detection of low‐level molecular markers. Recently, we described a combination of two amplification methods: (i) the use of paramagnetic liposomes that can be prepared with a high payload of Gd³⁺‐containing lipid; and (ii) targeting to a cell‐surface receptor that can undergo multiple rounds of nanoparticle delivery in the cell, followed by recycling to the cell membrane. Liposome uptake was monitored over a period of 24 h and was found to lead to massive delivery in subcellular compartments. The present study aimed to monitor the longer‐term fate of the cell‐internalized contrast material by studying its relaxometric properties over 5 days, following an initial 24 h loading period. Circa 25% of the Gd³⁺‐content delivered to the cells via integrin‐targeted liposomes was lost in the first 24 h, which led to 65 and 77% reductions in R₁ and R₂, respectively, as compared with the original R₁ and R₂ enhancements. This implies that the remaining cell‐associated gadolinium had relatively low effective r₁ and r₂ relaxivities. It is proposed that this is due to gradual release of Gd³⁺ from the chelate in the cell, followed by sequestration in an MR silent state. Most of the gadolinium internalized by cells following incubation with non‐targeted liposomes was released in the 5‐day follow‐up period. Copyright © 2010 John Wiley & Sons, Ltd.     

Changes in quality-of-life after pacemaker implantation: responsiveness of the Aquarel questionnaire

Before being introduced for widespread use, health status instruments should be evaluated for reliability, validity, and responsiveness to relevant clinical changes. In a previous study the validity and reliability of Aquarel, a disease-specific quality-of-life (QOL) questionnaire for pacemaker patients, were tested and found satisfactory. The purpose of this study was to assess the sensitivity to change in health of Aquarel. A cohort of 51 patients was assessed at baseline and at 4-6 weeks after pacemaker implantation. We compared the sensitivity to change over time on the Aquarel scores to the scores on the SF-36 using various techniques (t-test value, effect size, standard error of measurement). Using the 1-standard error of measurement (SEM) criterion for clinically relevant change, Aquarel seemed to provide better classification of patients compared to the SF-36 alone. This study supports the value of Aquarel as a disease-specific measure of QOL in pacemaker patients.