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Introduction Although visual and quantitative assessments of [18F]FDG PET/CT studies typically rely on liver uptake value as a reference or normalisation factor, consensus or consistency in measuring [18F]FDG uptake is lacking. Therefore, we evaluate the variation of several liver standardised uptake value (SUV) measurements in lymphoma [18F]FDG PET/CT studies using different uptake metrics. Methods PET/CT scans from 34 lymphoma patients were used to calculate SUVmaxliver, SUVpeakliver and SUVmeanliver as a function of (1) volume-of-interest (VOI) size, (2) location, (3) imaging time point and (4) as a function of total metabolic tumour volume (MTV). The impact of reconstruction protocol on liver uptake is studied on 15 baseline lymphoma patient scans. The effect of noise on liver SUV was assessed using full and 25% count images of 15 lymphoma scans. Results Generally, SUVmaxliver and SUVpeakliver were 38% and 16% higher compared to SUVmeanliver. SUVmaxliver and SUVpeakliver increased up to 31% and 15% with VOI size while SUVmeanliver remained unchanged with the lowest variability for the largest VOI size. Liver uptake metrics were not affected by VOI location. Compared to baseline, liver uptake metrics were 15–18% and 9–18% higher at interim and EoT PET, respectively. SUVliver decreased with larger total MTVs. SUVmaxliver and SUVpeakliver were affected by reconstruction protocol up to 62%. SUVmax and SUVpeak moved 22% and 11% upward between full and 25% count images. Conclusion SUVmeanliver was most robust against VOI size, location, reconstruction protocol and image noise level, and is thus the most reproducible metric for liver uptake. The commonly recommended 3 cm diameter spherical VOI-based SUVmeanliver values were only slightly more variable than those seen with larger VOI sizes and are sufficient for SUVmeanliver measurements in future studies. Trial registration EudraCT: 2006–005,174-42, 01–08-2008.

Purpose: To compare the predictive value of new immunotherapy-specific fluorine-18-labeled glucose Positron Emission Tomography/Computed Tomography ([18F]FDG PET/CT) response criteria to conventional PET/CT criteria for overall survival (OS) in melanoma and lung cancer patients treated with immunotherapy. Methods: MEDLINE (Ovid), Embase, Scopus, Web of Science and the Cochrane Library databases were searched until June 4, 2021, in line with the PRISMA statement. Two reviewers independently screened resulting records. Quality assessment was performed according to Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) and/or Quality in Prognostic Studies (QUIPS) criteria. PET/CT response assessment was divided in immunotherapy PET/CT response criteria, conventional PET/CT response criteria, and individual Δ[18F]FDG/PET CT metrics. The main outcome measure extracted was the univariate hazard ratio (HR) for OS. Results: Fifteen studies (n = 565) were included, with ten studies (225 NSCLC, 178 melanoma cases) reporting on PET/CT response criteria and five studies (126 NSCLC, 36 melanoma cases) on individual Δ[18F]FDG PET/CT metrics. Until 2016, conventional criteria: EORTC and PERCIST1.0 were applied; since then, several new, modified criteria emerged: imPERCIST, PERCIMT, PECRIT and iPERCIST. For both NSCLC and melanoma, univariate HRs did not show substantial differences between immunotherapy and conventional PET/CT response criteria, with overlapping confidence intervals. No individual Δ[18F]FDG PET/CT metric can yet be recommended. ΔTMTV in melanoma and ΔSUVmax in NSCLC showed the highest univariate HRs. Conclusion: There is insufficient evidence to decide whether the predictive value of immunotherapy PET/CT criteria is superior to conventional ones for OS, in melanoma and lung cancer treated with immunotherapy. A different research strategy is needed to reach the answer: PET/CT research should focus on directly comparing (modifications of) immunotherapy and conventional PET/CT criteria within a homogenous population with standardized PET timing, immunotherapy categories and OS definition. A consortium-based comprehensive database with individual patient data could be the solution.

Although visual and quantitative assessments of [18F]FDG PET/CT studies typically rely on liver uptake value as a reference or normalisation factor, consensus or consistency in measuring [18F]FDG uptake is lacking. Therefore, we evaluate the variation of several liver standardised uptake value (SUV) measurements in lymphoma [18F]FDG PET/CT studies using different uptake metrics.PET/CT scans from 34 lymphoma patients were used to calculate SUVmaxGenerally, SUVmaxSUVmeanEudraCT: 2006-005,174-42, 01-08-2008.

Blood-based biomarkers are gaining interest for response evaluation in classical Hodgkin lymphoma (cHL). However, it is unknown how blood-based biomarkers relate to quantitative 18F-FDG-PET features. We correlated extracellular vesicle-associated miRNAs (EV-miRNA), serum TARC, and complete blood count (CBC) with PET features (e.g., metabolic tumor volume [MTV], dissemination and intensity features) in 30 cHL patients at baseline. EV-miR127-3p, EV-miR24-3p, sTARC, and several CBC parameters showed weak to strong correlations with MTV and dissemination features, but not with intensity features. Two other EV-miRNAs only showed weak correlations with PET features. Therefore, blood-based biomarkers may be complementary to PET features, which warrants further exploration of combining these biomarkers in prognostic models.

Purpose: To clarify and elaborate on the choices that were made in the development of the Patient Scale of the Patient and Observer Scar Assessment Scale 3.0 (POSAS 3.0), based upon the rich information obtained from patients during focus groups and pilot tests. Methods: The discussions described in this paper are a reflection of the focus group study and pilot tests that were conducted in order to develop the Patient Scale of the POSAS3.0. The focus group took place in the Netherlands and Australia and included 45 participants. Pilot test interviews were performed with 15 participants in Australia, the Netherlands, and the United Kingdom.Results: We discussed the selection and wording of 9 included items. The merging 8 characteristics into 4 items was discussed. Finally, the reasons for exclusion of 23 characteristics are given. Conclusion: Based upon the unique and rich material of patient input obtained, two versions of the Patient Scale of the POSAS3.0 were developed: the Generic version, and the Linear scar version. The discussions and decisions taken during the development are informative for a good understanding of the POSAS 3.0 and are indispensable as a background for future translations and cross-cultural adaptations.

Forensic High and Intensive Care (FHIC) has recently been developed as a new care model in Dutch forensic psychiatry. FHIC aims to provide contact-based care. To support Dutch forensic care institutions in the implementation of the model, a model fidelity scale was developed called the FHIC monitor. The aim of this study was to assess the inter-rater reliability, content validity, and construct validity of the FHIC monitor. A multi-methods design was used, combining qualitative and quantitative research. To collect data, audits and focus group meetings were organized to score care at individual wards with the monitor and get feedback from auditors and audit receiving teams about the quality of the monitor. In total, fifteen forensic mental healthcare institutions participated. The instrument showed acceptable inter-rater reliability and content validity, and a significant difference between expected high and low scoring institutions, supporting construct validity. The instrument can be used as a valid instrument to measure the level of implementation of the FHIC model on forensic psychiatric wards in the Netherlands.

Purpose Biomarkers that can accurately predict outcome in DLBCL patients are urgently needed. Radiomics features extracted from baseline [18F]-FDG PET/CT scans have shown promising results. This study aims to investigate which lesion- and feature-selection approaches/methods resulted in the best prediction of progression after 2 years. Methods A total of 296 patients were included. 485 radiomics features (n = 5 conventional PET, n = 22 morphology, n = 50 intensity, n = 408 texture) were extracted for all individual lesions and at patient level, where all lesions were aggregated into one VOI. 18 features quantifying dissemination were extracted at patient level. Several lesion selection approaches were tested (largest or hottest lesion, patient level [all with/without dissemination], maximum or median of all lesions) and compared to the predictive value of our previously published model. Several data reduction methods were applied (principal component analysis, recursive feature elimination (RFE), factor analysis, and univariate selection). The predictive value of all models was tested using a fivefold cross-validation approach with 50 repeats with and without oversampling, yielding the mean cross-validated AUC (CV-AUC). Additionally, the relative importance of individual radiomics features was determined. Results Models with conventional PET and dissemination features showed the highest predictive value (CV-AUC: 0.72–0.75). Dissemination features had the highest relative importance in these models. No lesion selection approach showed significantly higher predictive value compared to our previous model. Oversampling combined with RFE resulted in highest CV-AUCs. Conclusion Regardless of the applied lesion selection or feature selection approach and feature reduction methods, patient level conventional PET features and dissemination features have the highest predictive value. Trial registration number and date: EudraCT: 2006–005174-42, 01–08-2008.

Consensus about a standard segmentation method to derive metabolic tumor volume (MTV) in classical Hodgkin lymphoma (cHL) is lacking, and it is unknown how different segmentation methods influence quantitative PET features. Therefore, we aimed to evaluate the delineation and completeness of lesion selection and the need for manual adaptation with different segmentation methods, and to assess the influence of segmentation methods on the prognostic value of MTV, intensity, and dissemination radiomics features in cHL patients. Methods: We analyzed a total of 105 (18)F-FDG PET/CT scans from patients with newly diagnosed (n = 35) and relapsed/refractory (n = 70) cHL with 6 segmentation methods: 2 fixed thresholds on SUV4.0 and SUV2.5, 2 relative methods of 41% of SUV(max) (41max) and a contrast-corrected 50% of SUV(peak) (A50P), and 2 combination majority vote (MV) methods (MV2, MV3). Segmentation quality was assessed by 2 reviewers on the basis of predefined quality criteria: completeness of selection, the need for manual adaptation, and delineation of lesion borders. Correlations and prognostic performance of resulting radiomics features were compared among the methods. Results: SUV4.0 required the least manual adaptation but tended to underestimate MTV and often missed small lesions with low (18)F-FDG uptake. SUV2.5 most frequently included all lesions but required minor manual adaptations and generally overestimated MTV. In contrast, few lesions were missed when using 41max, A50P, MV2, and MV3, but these segmentation methods required extensive manual adaptation and overestimated MTV in most cases. MTV and dissemination features significantly differed among the methods. However, correlations among methods were high for MTV and most intensity and dissemination features. There were no significant differences in prognostic performance for all features among the methods. Conclusion: A high correlation existed between MTV, intensity, and most dissemination features derived with the different segmentation methods, and the prognostic performance is similar. Despite frequently missing small lesions with low (18)F-FDG avidity, segmentation with a fixed threshold of SUV4.0 required the least manual adaptation, which is critical for future research and implementation in clinical practice. However, the importance of small, low (18)F-FDG–avidity lesions should be addressed in a larger cohort of cHL patients.

Objectives To assess the interobserver agreement in categories of electrocardiogram (ECG) abnormalities using the Minnesota Code criteria. Methods We used a random sample of 180 ECGs from people with type 2 diabetes. ECG abnormalities were classified and coded using the Minnesota ECG Classification. Each ECG was independently rated on several abnormalities by an experienced rater (rater 1) and by two cardiologists (raters 2 and 3) trained to apply the Minnesota codes on four Minnesota codes; 1-codes as an indication for myocardial infarction, 4 en 5-codes as an indication for ischemic abnormalities, 3-codes as an indication for left ventricle hypertrophy, 7-1-codes as an indication for ventricular conduction abnormalities, and 8-3-codes as an indication for atrial fibrillation / atrial flutter. After all pairwise tables were summed, the overall agreement, the specific positive and negative agreement were calculated with a 95% confidence interval (CI) for each abnormality. Also, Kappa’s with a 95% CI were calculated. Results The overall agreement (with 95% CI) were for myocardial infarction, ischemic abnormalities, left ventricle hypertrophy, conduction abnormalities and atrial fibrillation/atrial flutter respectively: 0.87 (0.84–0.91), 0.79 (0.74–0.84), 0.81 (0.76–0.85), 0.93 (0.90–0.95), 0.96 (0.93–0.97). Conclusion This study shows that the overall agreement of the Minnesota code is good to excellent.

Study objective: Older adults presenting to the emergency department (ED) are at high risk of adverse health outcomes. This study aimed to evaluate the accuracy of 4 frequently used screening instruments for the prediction of adverse health outcomes among older adults in the ED. Methods: This was a prospective cohort study in patients ≥70 years of age presenting to the ED in 2 hospitals in the Netherlands. Screening instruments included the acutely presenting older patient screening program (APOP) (providing 2 risk scores—functional decline [APOP1] and mortality [APOP2]), the International Resident Assessment Instrument Emergendy Department screener (InterRAI ED), the Identification of Seniors At Risk-Hospitalized Patients (ISAR-HP), and the safety management system (VMS). The primary outcome measure was a composite outcome encompassing functional decline, institutionalization, and mortality at 3 months after ED presentation. Other follow-up time points were 1 and 6 months. Analyses were performed to assess prognostic accuracy. Results: In total, 889 patients were included. After 3 months, 267 (31%) patients experienced at least 1 adverse outcome. The positive likelihood ratio ranged from 1.67 (VMS) to 3.33 (APOP1), and the negative likelihood ratio ranged from 0.41 (ISAR-HP) to 0.88 (APOP2). Sensitivity ranged from 17% (APOP2) to 74% (ISAR-HP), and specificity ranged from 63% (ISAR-HP) to 94% (APOP2). The area under the curve ranged from 0.62 (APOP2) to 0.72 (APOP1 and ISAR-HP). Calibration was reasonable for APOP1 and VMS. The prognostic accuracy was comparable across all outcomes and at all follow-up time points. Conclusion: The frailty screening instruments assessed in this study showed poor to moderate prognostic accuracy, which brings into question their usability in the prediction of adverse health outcomes among older adults who present to the ED.

Metabolic tumor volume (MTV) on interim PET (I-PET) is a potential prognostic biomarker for diffuse large B-cell lymphoma (DLBCL). Implementation of MTV on I-PET requires a consensus on which semiautomated segmentation method delineates lesions most successfully with least user interaction. Methods used for baseline PET are not necessarily optimal for I-PET because of lower lesional SUVs at I-PET. Therefore, we aimed to evaluate which method provides the best delineation quality for Deauville score (DS) 4–5 DLBCL lesions on I-PET at the best interobserver agreement on delineation quality and, second, to assess the effect of lesional SUV(max) on delineation quality and performance agreement. Methods: DS 4–5 lesions from 45 I-PET scans were delineated using 6 semiautomated methods: a fixed SUV threshold of 2.5 g/cm(3), a fixed SUV threshold of 4.0 g/cm(3), an adaptive threshold corrected for source-to-local background activity contrast at 50% of the SUV(peak), 41% of SUV(max) per lesion, a majority vote including voxels detected by at least 2 methods, and a majority vote including voxels detected by at least 3 methods (MV3). Delineation quality per MTV was rated by 3 independent observers as acceptable or nonacceptable. For each method, observer scores on delineation quality, specific agreement, and MTV were assessed for all lesions and per category of lesional SUV(max) (10). Results: In 60 DS 4–5 lesions on I-PET, MV3 performed best, with acceptable delineation in 90% of lesions and a positive agreement of 93%. Delineation quality scores and agreement per method strongly depended on lesional SUV: the best delineation quality scores were obtained using MV3 in lesions with an SUV(max) of less than 10 and using SUV4.0 in more (18)F-FDG–avid lesions. Consequently, overall delineation quality and positive agreement improved by applying the most preferred method per SUV category instead of using MV3 as the single best method. The MV3- and SUV4.0-derived MTVs of lesions with an SUV(max) of more than 10 were comparable after exclusion of visually failed MV3 contouring. For lesions with an SUV(max) of less than 10, MTVs using different methods correlated poorly. Conclusion: On I-PET, MV3 performed best and provided the highest interobserver agreement regarding acceptable delineations of DS 4–5 DLBCL lesions. However, delineation-method preference strongly depended on lesional SUV. Therefore, we suggest exploration of an approach that identifies the optimal delineation method per lesion as a function of tumor (18)F-FDG uptake characteristics, that is, SUV(max).

Purpose Correct identification of tumour receptor status is important for treatment decisions in breast cancer. [18F]FES PET and [18F]FDHT PET allow non-invasive assessment of the oestrogen (ER) and androgen receptor (AR) status of individual lesions within a patient. Despite standardised analysis techniques, interobserver variability can significantly affect the interpretation of PET results and thus clinical applicability. The purpose of this study was to determine visual and quantitative interobserver variability of [18F]FES PET and [18F]FDHT PET interpretation in patients with metastatic breast cancer. Methods In this prospective, two-centre study, patients with ER-positive metastatic breast cancer underwent both [18F]FES and [18F]FDHT PET/CT. In total, 120 lesions were identified in 10 patients with either conventional imaging (bone scan or lesions > 1 cm on high-resolution CT, n = 69) or only with [18F]FES and [18F]FDHT PET (n = 51). All lesions were scored visually and quantitatively by two independent observers. A visually PET-positive lesion was defined as uptake above background. For quantification, we used standardised uptake values (SUV): SUVmax, SUVpeak and SUVmean. Results Visual analysis showed an absolute positive and negative interobserver agreement for [18F]FES PET of 84% and 83%, respectively (kappa = 0.67, 95% CI 0.48–0.87), and 49% and 74% for [18F]FDHT PET, respectively (kappa = 0.23, 95% CI − 0.04–0.49). Intraclass correlation coefficients (ICC) for quantification of SUVmax, SUVpeak and SUVmean were 0.98 (95% CI 0.96–0.98), 0.97 (95% CI 0.96–0.98) and 0.89 (95% CI 0.83–0.92) for [18F]FES, and 0.78 (95% CI 0.66–0.85), 0.76 (95% CI 0.63–0.84) and 0.75 (95% CI 0.62–0.84) for [18F]FDHT, respectively. Conclusion Visual and quantitative evaluation of [18F]FES PET showed high interobserver agreement. These results support the use of [18F]FES PET in clinical practice. In contrast, visual agreement for [18F]FDHT PET was relatively low due to low tumour-background ratios, but quantitative agreement was good. This underscores the relevance of quantitative analysis of [18F]FDHT PET in breast cancer. Trial registration ClinicalTrials.gov, NCT01988324. Registered 20 November 2013, https://clinicaltrials.gov/ct2/show/NCT01988324?term=FDHT+PET&draw=1&rank=2.

Purpose In-vivo quantification of tumor uptake of 89-zirconium (89Zr)-labelled monoclonal antibodies (mAbs) with PET provides a potential tool in strategies to optimize tumor targeting and therapeutic efficacy. A specific challenge for 89Zr-immuno-PET is low tumor contrast. This is expected to result in interobserver variation in tumor delineation. Therefore, the aim of this study was to determine interobserver reproducibility of tumor uptake measures by tumor delineation on 89Zr-immuno-PET scans. Methods Data were obtained from previously published clinical studies performed with 89Zr-rituximab, 89Zr-cetuximab and 89Zr-trastuzumab. Tumor lesions on 89Zr-immuno-PET were identified as focal uptake exceeding local background by a nuclear medicine physician. Three observers independently manually delineated volumes of interest (VOI). Maximum, peak and mean standardized uptake values (SUVmax, SUVpeak and SUVmean) were used to quantify tumor uptake. Interobserver variability was expressed as the coefficient of variation (CoV). The performance of semi-automatic VOI delineation using 50% of background-corrected ACpeak was described. Results In total, 103 VOI were delineated (3–6 days post injection (D3-D6)). Tumor uptake (median, interquartile range) was 9.2 (5.2–12.6), 6.9 (4.0–9.6) and 5.5 (3.3–7.8) for SUVmax, SUVpeak and SUVmean. Interobserver variability was 0% (0–12), 0% (0–2) and 7% (5–14), respectively (n = 103). The success rate of the semi-automatic method was 45%. Inclusion of background was the main reason for failure of semi-automatic VOI. Conclusions This study shows that interobserver reproducibility of tumor uptake quantification on 89Zr-immuno-PET was excellent for SUVmax and SUVpeak using a standardized manual procedure for tumor segmentation. Semi-automatic delineation was not robust due to limited tumor contrast. Electronic supplementary material The online version of this article (10.1007/s00259-019-04377-6) contains supplementary material, which is available to authorized users.

We aimed to assess the interobserver agreement of interim PET (I-PET) and end-of-treatment PET (EoT-PET) using the Deauville score (DS) in first-line diffuse large B-cell lymphoma (DLBCL) patients.

For the assessment of the nasolabial appearance in cleft patients, a widely accepted, reliable scoring system is not available. In this study four different methods of assessment are compared, including 2D and 3D asymmetry and aesthetic assessments.The data and ratings from an earlier study using the Asher-McDade aesthetic index on 3D photographs and the outcomes of 3D facial distance mapping were compared to a 2D aesthetic assessment, the Cleft Aesthetic Rating Scale, and to SymNose, a computerized 2D asymmetry assessment technique. The reliability and correlation between the four assessment techniques were tested using a sample of 79 patients.The 3D asymmetry assessment had the highest reliability and could be performed by just one observer (Intraclass correlation coefficient (ICC): 0.99). The 2D asymmetry assessment of the nose was highly reliable when performed by just one observer (ICC: 0.89). However, for the 2D asymmetry assessment of the lip more observers were needed. For the 2D aesthetic assessments 3 observers were needed. The 3D aesthetic assessment had the lowest single-observer reliability (ICC: 0.38-0.56) of all four techniques. The agreement between the different assessment methods is poor to very poor. The highest correlation (R: 0.48) was found between 2D and 3D aesthetic assessments. Remarkably, the lowest correlations were found between 2D and 3D asymmetry assessments (0.08-0.17).Different assessment methods are not in agreement and seem to measure different nasolabial aspects. More research is needed to establish exactly what each assessment technique measures and which measurements or outcomes are relevant for the patients.

Background Decision-making about palliative care for metastatic colorectal cancer (mCRC) consists of many different treatment-related decisions, and there generally is no best treatment option. Decision support systems (DSS), e.g., prognostic calculators, can aid oncologists’ decision-making. DSS that contain features tailored to the needs of oncologists are more likely to be implemented in clinical practice. Therefore, our aim is to inventory colorectal cancer specialists’ unmet decision support needs. Methods We asked oncologists from the Dutch colorectal cancer group (DCCG), to participate in an online inventory questionnaire on their unmet decision support needs. To get more in-depth insight in required features of the DSS they need, we also conducted semi-structured telephone interviews. Results Forty-one oncologists started the inventory questionnaire, and 27 of them completed all items. Of all respondents, 18 were surgeons (44%), 22 were medical oncologists (54%), and 28 (68%) had more than 10 years of experience treating mCRC. In both the inventory questionnaire and interviews, respondents expressed a need for an overarching DSS incorporating multiple treatment options, and presenting both the treatment benefits and harms. Respondents found it relevant for other outcomes, such as cost-effectiveness of treatment or quality of life, to be incorporated in DSS. There was also a wish for DSS incorporating an up-to-date “personalized” overview of the ongoing trials for which a specific patient is eligible. Conclusions Experienced oncologists indicate that their treatment advice is currently almost solely based on the available clinical guidelines. They experience a lack of good quality DSS to help them personalize their treatment advice. New tools integrating multiple treatment options and providing a broad range of clinically relevant outcomes are urgently needed to stimulate and safeguard more personalized treatment decision-making.

This study aimed to assess the degree of implementation and barriers encountered in the use of a practice guideline for optimal symptom relief for patients with dementia and pneumonia in Dutch nursing homes.A process evaluation included assessment of reach, fidelity, and dose delivered using researcher's observations, and dose received was addressed in a question "use of the practice guideline," which the physicians completed for each patient included in the study. Perceived barriers were assessed with a structured questionnaire (response 69%) and semi-structured interviews (n = 14), which were subject to qualitative content analysis.Of the 55 physicians involved in the intervention phase, 87% attended an implementation meeting; 20 physicians joined the study later (reach). The intervention was implemented as planned, and all intervention components were delivered by the researchers (fidelity and dose delivered). Thirty-six physicians included 109 patients. For 81% of the patients, the treating physician stated to have used the guideline (dose received). The guideline was perceived as providing a good overview of current practice, but some physicians had expected a more directive protocol or algorithm. Further, recommended regular observations of symptoms were rarely performed. Physician's often felt that "this is not different from what we usually do," and with the acute illness, there was not always enough time to (re)familiarize with the contents.The physicians used the practice guideline frequently despite important barriers. Future implementation may involve strategies such as multiple interactive meetings. Further, the greatest potential to alter usual practice should be emphasized, such as using observational instruments. Copyright © 2016 John WileySons, Ltd.

Contains fulltext : 170948.pdf (Publisher’s version ) (Open Access) OBJECTIVES: Record review is the most used method to quantify patient safety. We systematically reviewed the reliability and validity of adverse event detection with record review. DESIGN: A systematic review of the literature. METHODS: We searched PubMed, EMBASE, CINAHL, PsycINFO and the Cochrane Library and from their inception through February 2015. We included all studies that aimed to describe the reliability and/or validity of record review. Two reviewers conducted data extraction. We pooled kappa values (kappa) and analysed the differences in subgroups according to number of reviewers, reviewer experience and training level, adjusted for the prevalence of adverse events. RESULTS: In 25 studies, the psychometric data of the Global Trigger Tool (GTT) and the Harvard Medical Practice Study (HMPS) were reported and 24 studies were included for statistical pooling. The inter-rater reliability of the GTT and HMPS showed a pooled kappa of 0.65 and 0.55, respectively. The inter-rater agreement was statistically significantly higher when the group of reviewers within a study consisted of a maximum five reviewers. We found no studies reporting on the validity of the GTT and HMPS. CONCLUSIONS: The reliability of record review is moderate to substantial and improved when a small group of reviewers carried out record review. The validity of the record review method has never been evaluated, while clinical data registries, autopsy or direct observations of patient care are potential reference methods that can be used to test concurrent validity.

Characterization of the prognostic variables for persistent neuropathic pain (PNP) remains incomplete despite multiple articles addressing this topic. To provide more insight into the recovery and prognosis of neuropathic pain, high-quality data are required that provide information about the predictors that contribute to the development of PNP.To determine the methodological quality of studies about predictors for PNP and to summarize findings of predictors found in high-quality studies.A systematic review.VU University Medical Center, Amsterdam, The Netherlands.Studies were identified by searching the electronic databases PubMed, Embase, and Cochrane Library. Methodological quality of each article was independently assessed by 2 reviewers.Forty-six relevant studies were identified, classified into 4 different neuropathic pain (NP)-syndromes: postherpetic neuralgia (n = 35), radicular pain and sciatica (n = 3), postsurgical pain (n = 6), and other types of NP (n = 2). Seven studies were of high quality. The 3 high-quality studies found for PHN reported male gender, older age, smoking, trauma at the site of lesion, missed antiviral prescriptions, higher acute pain severity, higher rash severity, more neuropathic characteristics, shorter rash duration, and a lower health status as predictors for PNP. For persistence of radicular pain one high-quality study reported negative outcome expectancies, pain-related fear of movement, and passive pain coping as predictors for PNP. Psychological distress, acute pain, breast cancer surgery, higher body mass index, area of secondary hyperalgesia, neuropathic characteristics, hypoesthesia, and hyperesthesia were found to be predictive for postsurgical pain in 3 high-quality studies.Some publications may have been missed during literature search. The low-quality of the studies could be the result of an incomplete description of their methods.High-quality studies mainly assessed factors related to disease functions and structures. Due to shortcomings in methodological quality and limited areas of predictor selection, there is a need for high-quality studies focusing on predictor measurement, statistical analysis and the use of a standardized set of predictors.

To systematically summarize the literature on the course of pain in patients with knee osteoarthritis (OA), prognostic factors that predict deterioration of pain, the course of physical functioning, and prognostic factors that predict deterioration of physical functioning in persons with knee OA.A search was conducted in PubMed, CINAHL, Embase, Psych-INFO, and SPORTDiscus up to January 2014. A meta-analysis and a qualitative data synthesis were performed.Of the 58 studies included, 39 were of high quality. High heterogeneity across studies (I(2) 90%) and within study populations (reflected by large SDs of change scores) was found. Therefore, the course of pain and physical functioning was interpreted to be indistinct. We found strong evidence for a number of prognostic factors predicting deterioration in pain (e.g., higher knee pain at baseline, bilateral knee symptoms, and depressive symptoms). We also found strong evidence for a number of prognostic factors predicting deterioration in physical functioning (e.g., worsening in radiographic OA, worsening of knee pain, lower knee extension muscle strength, lower walking speed, and higher comorbidity count).Because of high heterogeneity across studies and within study populations, no conclusions can be drawn with regard to the course of pain and physical functioning. These findings support current research efforts to define subgroups or phenotypes within knee OA populations. Strong evidence was found for knee characteristics, clinical factors, and psychosocial factors as prognostics of deterioration of pain and physical functioning.

Study Design. Literature review and group discussions. Objective. To propose uniform definitions for low back pain episodes to be used in research. Background. Different definitions of episodes have been used in low back pain studies. This hampers comparison of study results. Definitions are proposed for episodes of low back pain, care for low back pain, and work absence because of low back pain. Methods. In a Medline search, we identified about 1200 papers, of which 81 possibly contained a definition of episodes. In group discussions, we decided which definitions to propose and discussed their applicability. Results. We found few definitions in the literature. In the group discussions we decided to define an episode of LBP as a period of pain in the lower back lasting for more than 24 hours, preceded and followed by a period of at least 1 month without low back pain. An episode of care for low back pain was defined as a consultation or a series of consultations for low back pain, preceded and followed by at least 3 months without consultation for low back pain. An episode of work absence due to low back pain was defined as a period of work absence due to low back pain, preceded and followed by a period of at least 1 day at work. Conclusions. In many studies, episodes of low back pain are mentioned without a clear definition. We consider our proposed definitions of episodes to be arbitrary but well considered. We advise that they be tested for use in future research.

Recently, the Individual Work Performance Questionnaire (IWPQ) version 0.2 was developed using Rasch analysis. The goal of the current study was to improve targeting of the IWPQ scales by including additional items. The IWPQ 0.2 (original) and 0.3 (including additional items) were examined using Rasch analysis. Additional items that showed misfit or did not improve targeting were removed from the IWPQ 0.3, resulting in a final IWPQ 1.0. Subsequently, the scales showed good model fit and reliability, and were examined for key measurement requirements (e.g., category ordening, unidimensionality, and differential item functioning). Finally, calculation and interpretability of scores were addressed. Compared to its previous version, the final IWPQ 1.0 showed improved targeting for two out of three scales. As a result, it can more reliably measure workers at all levels of ability, discriminate between workers at a wider range on each scale, and detect changes in individual work performance.

This study aimed to develop a practice guideline for a structured and consensus-based approach to relieve symptoms of pneumonia in patients with dementia in nursing homes.A five-round Delphi study involving a panel consisting of 24 experts was conducted. An initial version of the practice guideline was developed with leading representatives of Dutch University Medical Centers with a department for elderly care medicine, based on existing guidelines for palliative care. The experts evaluated the initial version, after which we identified topics that reflected the main divergences. The experts rated their agreement with statements that addressed the main divergences on a 5-point Likert scale. Consensus was determined according to pre-defined criteria. The practice guideline was then revised according to the final decisions made by the project group and the representatives.The response rate for the expert panel was 67%. Main divergences included the applicability of guidelines for palliative care to patients with dementia and pneumonia in long-term care and the appropriateness of specific pharmacological treatment of dyspnea and coughing. Moderate consensus was reached for 80% of the statements. Major revisions included adding pharmacological treatment for coughing and recommending opioid rotation in the case of opioid-induced delirium. Two areas of divergent opinion remained: the usefulness of oxygen administration and treatment of rattling breath. The project group made the final decision in these areas.We developed a mostly consensus-based practice guideline for patients with dementia and pneumonia and mapped controversial issues for future investigation.

To analyse possible trends in families' evaluations of the quality of end-of-life care and the quality of dying in dementia.Analysis of individual patient data from 3 studies (2 solely retrospective (after death) and 1 partly prospective).We combined data on 372 residents with dementia from 38 nursing homes and 13 residential homes ('psychogeriatric' wards) over the period 2005-2010. Outcome measures were the End-of-Life in Dementia-Satisfaction With Care scale (EOLD-SWC; range: 10-40) to assess quality of, or satisfaction with, end-of-life care, and the EOLD-Comfort Assessment in Dying scale (EOLD-CAD; range: 12-42) to assess quality of dying (comfort). Regression analyses were performed with time (trend) as an independent factor and were adjusted for clustering of residents within homes. We also adjusted for differences between residents, homes, and study designs.We found a consistent trend of increasing family satisfaction with end-of-life care over the years (unadjusted: 0.5 points per year increment on the EOLD-SWC, and adjusted: 1.2 points; mean total score: 32.4 (SD: 5.3)). Results for the EOLD-CAD scale (mean: 32.2 (SD: 5.7)) were inconclusive; only the exclusively retrospective data indicated increased comfort. Item- and subscale-level analyses showed that, in particular, families were more satisfied with general (comfort) measures for residents and the emotional support provided for families; further, families reported lower levels of emotional distress in residents.We found a positive trend of increased satisfaction with end-of-life care. Families also reported a possible increase in residents' end-of-life comfort. Ongoing surveillance of outcomes measuring end-of-life quality is important in view of the increasing healthcare budget constraints.

The success of the Apgar score demonstrates the astounding power of an appropriate clinical instrument. This down-to-earth book provides practical advice, underpinned by theoretical principles, on developing and evaluating measurement instruments in all fields of medicine. It equips you to choose the most appropriate instrument for specific purposes. The book covers measurement theories, methods and criteria for evaluating and selecting instruments. It provides methods to assess measurement properties, such as reliability, validity and responsiveness, and interpret the results. Worked examples and end-of-chapter assignments use real data and well-known instruments to build your skills at implementation and interpretation through hands-on analysis of real-life cases. All data and solutions are available online. This is a perfect course book for students and a perfect companion for professionals/researchers in the medical and health sciences who care about the quality and meaning of the measurements they perform.

Training in and assessment of consultation skills are high on the agenda of vocational training institutes for postgraduate training. There is a need to establish valid and reliable instruments to assess consultation skills in authentic settings. We investigated the number of assessors and observations needed to achieve reliable assessments of the consultation skills of general practice trainees (GPTs) using a communication instrument (MAAS-Global) and either standardised patient (SP) encounters or videotaped real patient (RP) encounters.Eight teachers at the Vrije Universiteit (VU) University Medical Centre in Amsterdam attended a training course on the use of the MAAS-Global instrument, which they subsequently used to assess the consultation skills of 53 GPTs in 176 videotaped consultations (102 with SPs, 74 with RPs). All consultations were randomly allocated and assessed by two teachers independently. The reliability of the ratings was estimated using generalisability theory.It was easier to obtain acceptable reliability using RP consultations than SP consultations. Two assessors and five consultations were required to achieve minimal reliability (generalisability coefficient 0.7) with RPs, whereas three assessors and 30 consultations were needed to achieve minimal reliability with SPs.Inter-observer and context variability in the assessment of the consultation skills of GPTs remains high. To achieve acceptable levels of reliability, large samples of observations are required in both formats, but, interestingly, RP encounters require a smaller sample than SP encounters.

Study Design.: Cochrane systematic review of randomized controlled trials. Objective.: To evaluate the effects of active rehabilitation for adults after first-time lumbar disc surgery. Summary of Background Data.: Several rehabilitation programs are available for individuals after lumbar disc surgery, however, little is known about the efficacy of these treatments. Methods.: Search strategies were performed on CENTRAL (The Cochrane Library 2007, Issue 2) and MEDLINE, EMBASE, CINAHL, and PsycINFO up to May 2007. All randomized controlled trials without language limitations were included. Pairs of review authors independently assessed studies for eligibility and risk of bias. A meta-analysis was performed with clinically homogeneous studies. The GRADE approach was used to determine the quality of evidence. Results.: Fourteen studies were included, 7 of which had a low risk of bias. Most programs were only assessed in 1 study. Statistical pooling was only completed for 3 comparisons in which exercises started 4 to 6 weeks postsurgery: exercise programs versus no treatment, high versus low intensity exercise programs, and supervised versus home exercises. We found low quality evidence (3randomized controlled trials [RCTs], N = 122) that exercises are more effective than no treatment for pain atshort-term follow-up (weighted mean difference [WMD]:-11.13; 95% CI: -18.44 to -3.82) and moderate evidence (2 RCTs, N = 102) that exercises are more effective for functional status on short-term follow-up (WMD: -6.50; 95% CI: -9.26 to -3.74). None of the studies reported that exercises increased the reoperation rate. We also found low quality evidence (2 RCTs, N = 103) that high intensity exercises are slightly more effective than low intensity exercise programs for pain in the short-term (WMD: -10.67; 95% CI: -17.04 to -4.30) and moderate evidence (2 RCTs, N = 103) that they are more effective for functional status in the short-term (standardized mean difference [SMD] -0.77; 95% CI: -1.17 to -0.36). Finally, we found low quality evidence (3 RCTs, N = 95) that there were no significant differences between supervised and home exercises for short-term pain relief (SMD: -1.12; 95% CI: -2.77-0.53) or functional status (3 RCT, N = 95; SMD -1.17; 95% CI: -2.63-0.28). Conclusion.: Exercise programs starting 4 to 6 weeks postsurgery seem to lead to a faster decrease in pain and disability than no treatment. High intensity exercise programs seem to lead to a faster decrease in pain and disability than low intensity programs. There were no significant differences between supervised and home exercises for pain relief, disability, or global perceived effect. There is no evidence that active programs increase the reoperation rate after first-time lumbar surgery. © 2009 Lippincott Williams & Wilkins, Inc.

The reported relationships between nerve conduction studies (NCS) and outcome measures in carpal tunnel syndrome (CTS) are weak to moderate. However, selection of patients may have confounded nonrandomized studies. NCS have potentially great value in selecting patients for a specific treatment and in objectively assessing the efficacy of treatments in CTS, especially if they correlate significantly with clinical outcome measures. To investigate the relationship between clinical outcome measures for the severity of complaints and NCS in patients treated for CTS, data were obtained from a multicenter randomized controlled trial on the efficacy of splinting versus surgery for CTS. At baseline and 12 months after randomization, clinical outcome measures were assessed and NCS were performed. In total, 138 patients completed the questionnaires and underwent repeated NCS. Relationships were analyzed with Spearman rank correlation coefficients and Pearson correlation coefficients. All NCS parameters showed highly significant improvement compared with baseline (P0.001). Modest correlations (0.4) were found between the neurophysiologic and clinical outcome measures after 12 months, and between the changes in these different categories of outcome measures. This study confirms that the parameters of NCS improve significantly after treatment for CTS, but the modest correlations between neurophysiologic and clinical outcome measures do not support that NCS are routinely performed in clinical practice to evaluate treatment effects. However, studies investigating the effects of treatment for CTS should incorporate both clinical outcome measures and NCS, because they are complementary. Furthermore, NCS can provide additional information to the clinician when treatment effects are unsatisfactory.

The quality of reporting of studies of diagnostic accuracy is less than optimal. Complete and accurate reporting is necessary to enable readers to assess the potential for bias in a study and to evaluate the generalisability of the results. A group of scientists and editors has developed the STARD (Standards for Reporting of Diagnostic Accuracy) statement to improve the quality of reporting of studies of diagnostic accuracy. The statement consists of a checklist of 25 items and flow diagram that authors can use to ensure that all relevant information is present. This explanatory document aims to facilitate the use, understanding and dissemination of the checklist. The document contains a clarification of the meaning, rationale and optimal use of each item on the checklist, as well as a short summary of the available evidence on bias and applicability. The STARD statement, checklist, flowchart, and this explanation and elaboration document should be useful resources to improve the reporting of diagnostic accuracy studies. Complete and informative reporting can only lead to better decisions in health care.

To improve the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers to assess the potential for bias in a study and to evaluate the generalizability of its results.The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organizations shortened this list during a 2-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy.The search for published guidelines about diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25-item checklist, by using evidence whenever available. A prototype of a flow diagram provides information about the method of recruitment of patients, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard, or both.Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.

To comprehend the results of diagnostic accuracy studies, readers must understand the design, conduct, and analysis of such studies. The authors sought to develop guidelines for improving the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers better to assess the validity and generalizability of study results.The Standards for Reporting of Diagnostic Accuracy group steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and to extract potential guidelines for authors and editors. An extensive list of items was prepared. Members of the steering committee then met for 2 days with other researchers, editors, methodologists, statisticians, and members of professional organizations to develop a checklist and a prototypical flowchart to guide authors and editors of studies of diagnostic accuracy.The search for published guidelines on diagnostic research yielded 33 previously published checklists, from which the group produced an initial list of 75 items. This list was honed to 25 key items by group consensus and on the basis of published research on bias. A prototypical flowchart was developed as a tool for conveying information about the method of patient recruitment, the order of test execution, and the numbers of patients undergoing the test under evaluation, the reference test, or both. Potential users reviewed the conference version of the checklist and flowchart and provided additional suggestions, which were then incorporated.Use of these carefully developed, consensus-based guidelines should enable clearer and more complete reporting of studies of diagnostic accuracy, as well as better reader understanding of the validity and generalizability of study results.

To comprehend the results of diagnostic accuracy studies, readers must understand the design, conduct, analysis, and results of such studies. That goal can be achieved only through complete transparency from authors.To improve the accuracy and completeness of reporting of studies of diagnostic accuracy to allow readers to assess the potential for bias in the study and to evaluate its generalisability.The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a two-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy.The search for published guidelines on diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. The consensus meeting shortened the list to 25 items, using evidence on bias whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard or both.Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.

We studied the influence of the methodologic quality of individual trials on the outcome of a landmark meta-analysis on thrombolytic therapy in acute myocardial infarction. From each study we extracted the number of patients in both groups who died in hospital or during follow-up. Methodologic quality was assessed using the Delphi list. We first recalculated pooled odds ratios (ORs) and 95% confidence intervals (CIs), on the studies found and compared them with the original results of Yusuf et al. Next we incorporated the results of quality assessment in five different ways in the calculation of the pooled ORs: a) component analysis; b) visual plot; c) quality score as a threshold score; d) quality score as a weighting factor; and e) cumulative pooling.No correlation between quality scores and ORs was found. Studies with a proper description of the different quality components provided an estimate close to the true treatment effect. No major differences were found between the results of the five different methods of incorporating the quality scores into the final conclusion.

Snapping or grating scapula is a condition of the shoulder girdle in which the patient complains of pain and an audible snapping sound which may be associated with pain. We evaluated the diagnostic value of the computed tomography (CT) scans using the clinical diagnosis of a grating scapula as the gold standard. This retrospective study reports the sensitivity, specificity, likelihood ratio and receiver operator characteristic curve for the CT scans and the κ value as a measure of the interobserver agreement. None of the parameters validated the examination. We therefore concluded that CT scans are inappropriate for differentiation between a grating scapula and a normally functioning shoulder except in cases where bony abnormalities are present.