Abstract

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Abstract

OBJECTIVE: Assessment of psychological distress by patient report is necessary to meet patients' needs throughout the cancer journey. We have previously developed an item bank to assess psychological distress but not evaluated it for cancer survivors. Our first aim in this study was to test whether we could extend our item bank to include cancer survivors. The second aim was to examine whether the item bank could assess positive affect as a single construct alongside negative psychological symptoms.

METHODS: Responses from 1315 cancer survivors to the Hospital Anxiety and Depression Scale (HADS) and the Positive and Negative Affect Scale (PANAS) were considered for inclusion in a pre-existing item bank created from a heterogeneous sample of 4914 cancer patients. Differential item functioning (DIF) was used to assess whether HADS responses drawn from the two samples were equivalent. Common-item equating was used to anchor the shared (HADS) items, whilst the PANAS items were added. Item fit was evaluated at each stage, and misfitting items were removed. Unidimensionality was assessed with a principal components factor analysis.

RESULTS: The DIF analysis did not reveal any differences between the HADS item locations from the two samples. Three misfitting PANAS items were removed, resulting in a final unidimensional bank of 80 items with good internal reliability (a = 0.85).

CONCLUSION: The new item bank is valid for use across the cancer journey, including cancer survivors, and modestly improves the assessment of all levels of psychological distress and positive psychological function.

Abstract

OBJECTIVE: We aimed to redefine the optimal self-report symptoms of depression suitable for creation of an item bank that could be used in computer adaptive testing or to develop a simplified screening tool for DSM-V.

METHODS: Four hundred subjects (200 patients with primary depression and 200 non-depressed subjects), living in Iraqi Kurdistan were interviewed. The Mini International Neuropsychiatric Interview (MINI) was used to define the presence of major depression (DSM-IV criteria). We examined symptoms of depression using four well-known scales delivered in Kurdish. The Partial Credit Model was applied to each instrument. Common-item equating was subsequently used to create an item bank and differential item functioning (DIF) explored for known subgroups.

RESULTS: A symptom level Rasch analysis reduced the original 45 items to 24 items of the original after the exclusion of 21 misfitting items. A further six items (CESD13 and CESD17, HADS-D4, HADS-D5 and HADS-D7, and CDSS3 and CDSS4) were removed due to misfit as the items were added together to form the item bank, and two items were subsequently removed following the DIF analysis by diagnosis (CESD20 and CDSS9, both of which were harder to endorse for women). Therefore the remaining optimal item bank consisted of 17 items and produced an area under the curve (AUC) of 0.987. Using a bank restricted to the optimal nine items revealed only minor loss of accuracy (AUC = 0.989, sensitivity 96%, specificity 95%). Finally, when restricted to only four items accuracy was still high (AUC was still 0.976; sensitivity 93%, specificity 96%).

CONCLUSIONS: An item bank of 17 items may be useful in computer adaptive testing and nine or even four items may be used to develop a simplified screening tool for DSM-V major depressive disorder (MDD). Further examination of this item bank should be conducted in different cultural settings.

Abstract

This randomized clinical study assessed efficacy in terms of color change and production of sensitivity after home whitening alone and home whitening supplemented with in-office bleaching. Thirty-six subjects (aged 19 to 58 years) were randomly assigned to one of three different treatment groups: (A) home whitening for two weeks, with 16% carbamide peroxide in custom-made trays; (B) home whitening for two weeks, with 16% carbamide peroxide in custom-made trays supplemented with in-office bleaching with 9% hydrogen peroxide (in the same trays); or (C) home whitening for two weeks, with 16% carbamide peroxide in custom-made trays supplemented with in-office bleaching with 27% hydrogen peroxide (in the same trays). The efficacy of tooth whitening was assessed by determining the color change associated with the six upper anterior teeth using a value-ordered shade guide. Sensitivity was self-assessed with the use of a visual analog scale (VAS). Tooth shade and sensitivity were assessed at the following points: pretreatment; immediately after the home whitening phase; immediately after the in-office phase (groups B and C); and one week post active treatment. At the one week follow-up visit, subjects in group A had a mean (SD) color change of 5.9 (1.83) (teeth were lighter) immediately after cessation of treatment (p<0.01). Subjects in groups B and C experienced a greater change in mean (SD) shade immediately following their respective in-office treatments of 5.1 (1.53) and 5.4 (1.55). However, within one week, the shade of these teeth regressed to a similar degree to that achieved by subjects treated in group A. Overall, no significant difference in shade change or sensitivity was produced between the three groups. Investigators concluded that the in-office element of combined whitening produced no significant difference in tooth color or sensitivity when compared with home whitening alone.

Abstract

OBJECTIVES: In the UK, colorectal cancer (CRC) is the third most common malignancy (behind lung and breast cancer) with 37,514 cases registered in 2006: around two-thirds (23,384) in the colon and one-third (14,130) in the rectum. Treatment of cancers of the colon can vary considerably, but surgical resection is the mainstay of treatment for curative intent. Following surgical resection, there is a comprehensive assessment of the tumour, it's invasion characteristics and spread (tumour staging). A number of imaging modalities are used in the pre-operative staging of CRCs including; computerised tomography (CT), magnetic resonance imaging, ultrasound imaging and positron emission tomography (PET). This report examines the role of CT in combination with PET scanning (PET/CT 'hybrid' scan). The research objectives are: to evaluate the diagnostic accuracy and therapeutic impact of fluorine-18-deoxyglucose (FDG) PET/CT for the pre-operative staging of primary, recurrent and metastatic cancer using systematic review methods; undertake probabilistic decision-analytic modelling (using Monte Carlo simulation); and conduct a value of information analysis to help inform whether or not there is potential worth in undertaking further research.

DATA SOURCES: For each aspect of the research - the systematic review, the handsearch study and the economic evaluation - a database was assembled from a comprehensive search for published and unpublished studies, which included database searches, reference lists search and contact with experts. In the systematic review prospective and retrospective patient series (diagnostic cohort) and randomised controlled trials (RCTs) were eligible for inclusion. Both consecutive series and series that are not explicitly reported as consecutive were included.

REVIEW METHODS: Two reviewers extracted all data and applied the criteria independently and resolved disagreements by discussion. Data to populate 2×2 contingency tables consisting of the number of true positives, true negatives, false positives and false negatives using the studies' own definitions were extracted, as were data relating to changes in management. Fourteen items from the Quality Assessment of Diagnostic Accuracy Studies checklist were used to assess the methodological quality of the included studies. Patient-level data were used to calculate sensitivity and specificity with confidence intervals (CIs). Data were plotted graphically in forest plots. For the economic evaluation, economic models were designed for each of the disease states: primary, recurrent and metastatic. These were developed and populated based on a variety of information sources (in particular from published data sources) and literature, and in consultation with clinical experts.

RESULTS: The review found 30 studies that met the eligibility criteria. Only two small studies evaluated the use of FDG PET/CT in primary CRC, and there is insufficient evidence to support its routine use at this time. The use of FDG PET/CT for the detection of recurrent disease identified data from five retrospective studies from which a pooled sensitivity of 91% (95% CI 0.87% to 0.95%) and specificity of 91% (95% CI 0.85% to 0.95%) were observed. Pooled accuracy data from patients undergoing staging for suspected metastatic disease showed FDG PET/CT to have a pooled sensitivity of 91% (95% CI 87% to 94%) and a specificity of 76% (95% CI 58% to 88%), but the poor quality of the studies means the validity of the data may be compromised by several biases. The separate handsearch study did not yield any additional unique studies relevant to FDG PET/CT. Models for recurrent disease demonstrated an incremental cost-effectiveness ratio of £21,409 per quality-adjusted life-year (QALY) for rectal cancer, £6189 per QALY for colon cancer and £21,434 per QALY for metastatic disease. The value of handsearching to identify studies of less clearly defined or reported diagnostic tests is still to be investigated.

CONCLUSIONS: The systematic review found insufficient evidence to support the routine use of FDG PET/CT in primary CRC and only a small amount of evidence supporting its use in the pre-operative staging of recurrent and metastatic CRC, and, although FDG PET/CT was shown to change patient management, the data are divergent and the quality of research is generally poor. The handsearch to identify studies of less clearly defined or reported diagnostic tests did not find additional studies. The primary limitations in the economic evaluations were due to uncertainty and lack of available evidence from the systematic reviews for key parameters in each of the five models. In order to address this, a conservative approach was adopted in choosing DTA estimates for the model parameters. Probabilistic analyses were undertaken for each of the models, incorporating wide levels of uncertainty particularly for the DTA estimates. None of the economic models reported costsavings, but the approach adopted was conservative in order to determine more reliable results given the lack of current information. The economic evaluations conclude that FDG PET/CT as an add-on imaging device is cost-effective in the pre-operative staging of recurrent colon, recurrent rectal and metastatic disease but not in primary colon or rectal cancers. There would be value in undertaking an RCT with a concurrent economic evaluation to evaluate the therapeutic impact and cost-effectiveness of FDG PET/CT compared with conventional imaging (without PET) for the pre-operative staging of recurrent and metastatic CRC.

Abstract

BACKGROUND: Approximately 210 million people are estimated to have chronic obstructive pulmonary disease [COPD] worldwide. The burden of disease is known to be high, though less is known about those of a younger age. The aim of this study was to investigate the wider personal, economic and societal burden of COPD on a cross country working-age cohort.

METHODS: A cross-country [Brazil, China, Germany, Turkey, US, UK] cross-sectional survey methodology was utilised to answer the research questions. 2426 participants aged 45-67 recruited via a number of recruitment methods specific to each country completed the full survey. Inclusion criteria were a recalled physician diagnosis of COPD, a smoking history of > 10 pack years and the use of COPD medications in the previous 3 months prior to
questioning. The survey included items from the validated Work Productivity and Activity Impairment [WPAI] scale and the EuroQoL 5 Dimension [EQ-5D] scale. Disease severity was measured using the 5-point MRC [Medical Research Council] dyspnoea scale as a surrogate measure.

RESULTS: 64% had either moderate [n = 1012] or severe [n = 521] COPD, although this varied by country. 75% of the cohort reported at least one comorbid condition. Quality of life declined with severity of illness [mild, mean EQ-5D score = 0.84; moderate 0.58; severe 0.41]. The annual cost of healthcare utilisation [excluding treatment costs and diagnostic tests] per individual was estimated to be $2,364 [£1,500]. For those remaining in active employment [n: 677]: lost time from work cost the individual an average of $880 [£556] per annum and lifetime losses of $7,365 [£4,661] amounting to $596,000 [£377,000] for the cohort. 447 [~40%] of the working population had retired prematurely because of COPD incurring individual estimated lifetime income losses of $316,000 [£200,000] or a combined total of $141 m [£89.6 m]. As the mean age of retirees was 58.3 and average time since retirement was 4 years, this suggests the average age of retirement is around 54. This would mean a high societal and economic impact in all study countries, particularly where typical state retirement ages are higher, for example in Brazil, Germany and the UK [65] and the US [65,66,67], compared to Turkey [58 for women, 60 for men] and China [60].

CONCLUSIONS: Although generalisation across a broader COPD population is limited due to the varied participant recruitment methods, these data nevertheless suggest that COPD has significant personal, economic and societal burden on working age people. Further efforts to improve COPD diagnosis and management are required.

Abstract

Secondary use of patient databases is essential in healthcare if clinical trials are to progress efficiently to planned time and target and imperative if the planned UK expansion of research and development (R&D) at point of care is to be achieved. Integration of effective databases primarily designed to facilitate patient care with R&D requirements is needed but represents a complex challenge.
We present a system that achieves an integrated approach with online management of complex datasets for clinical trials within care records using a specific study as an example to show functionality in practice; illustrating how this system provides an ideal resource to meet the needs of both clinicians and researchers.