A patient-centred instrument for assessment of quality of breast cancer care: results of a pilot questionnaire.

BACKGROUND: In several breast cancer research environments, there was a need to develop a questionnaire that would (1) provide data on how breast cancer patients experience healthcare services, (2) address issues corresponding with patients' needs and expectations and (3) produce useful data for quality assessment and improvement projects aimed at breast cancer care. This article describes the first part of the quantitative process of item selection, instrument construction and optimisation based on the results of a pilot questionnaire. METHODS: Based on qualitative research, a pilot questionnaire with items formulated as "performance" and "importance" statements was developed and sent to all breast cancer patients operated on in the previous 3-15 months in five participating hospitals. Reduction criteria, exploratory factor analysis and reliability analysis were used as part of the process of instrument optimisation. RESULTS: Of the 637 questionnaires sent out, 299 (47%) were returned and 276 (43%) were used for analyses. Out of the 72 quality items included in the pilot questionnaire, 42 items did not meet the inclusion criteria for the revised version. The remaining items refer to the factors patient education regarding aspects related to postoperative treatment, services by the breast nurse, services by the surgeon, patient education regarding activities at home and patient education regarding aspects related to preoperative treatment (Cronbach α = 0.70-0.89). CONCLUSIONS: In this study, the number of items to be included in the self-administered questionnaire was reduced. The resulting set of items that determines patients' perceptions on quality of breast cancer care is easy to complete and enables anonymous responses. Further research can be aimed at establishing the reliability of the current questionnaire.

Location of involved mesorectal and extramesorectal lymph nodes in patients with primary rectal cancer: preoperative assessment with MR imaging.

AIM: The purpose of this study is to evaluate the location of involved mesorectal and extramesorectal lymph nodes as depicted on preoperative MRI. Preoperative availability of this information might be useful for the surgeon as well as the radiation therapist and medical oncologist for optimal treatment strategy: type and extent of neoadjuvant treatment as well as extent of surgical resection. METHODS: Forty-one patients with biopsy-proven rectal cancer were included. All patients underwent preoperative MRI using USPIO (lymph node specific contrast agent). Location of all mesorectal and extramesorectal nodes visible on MRI was recorded, as well as USPIO prediction on nodal status. Lesion-by-lesion analysis using histology after surgery was performed for patients who did not receive long course chemoradiation therapy. RESULTS: There were 438 nodes visible, 94 of which were malignant. Most nodes are located in the laterodorsal part of the mesorectum, with no difference in distribution between positive and negative nodes. In relation to height of tumor, the majority of positive nodes are located at tumor height or above. There were significantly more negative nodes (9.6%) located below tumor height as compared to positive nodes (2.1%). There were 40 extramesorectal nodes, in 16 patients, 5 of which were positive in 4 patients. All patients had distal rectal cancer. CONCLUSION: In conclusion, positive mesorectal nodes are located in the laterodorsal part of the mesorectum, at tumor height or above. Positive nodes distal to the tumor are rare, and occur in patients with more proximal nodal metastases. Positive extramesorectal nodes mainly occur in patients with distal rectal cancer with nodal metastases in the mesorectum.

[Peripheral artery disease: clinical and cost comparison between duplex ultrasonography and contrast-enhanced magnetic resonance angiography--a multicenter randomized trial]. / De kosten en de effecten van magnetischeresonantieangiografie en duplexechografie bij patiënten met perifeer arterieel vaatlijden: een multicentrische gerandomiseerde studie.

OBJECTIVE: To determine the clinical and economic consequences of replacing duplex ultrasonography (DUS) by contrast-enhanced magnetic resonance angiography (CE-MRA) for the initial diagnostic work-up of patients with peripheral artery disease (PAD). DESIGN: Randomised multicentre study. METHOD: In the period from January 2002 to August 2003, consecutive patients with PAD were randomly assigned to CE-MRA or DUS. The primary outcome measure was the costs. Secondary outcome measures included the confidence with which the specialist could take a therapeutic decision on the basis of the imaging study, the change in disease severity, and the change in quality of life (QOL) assessed during 6 months of follow-up. In addition, all costs of imaging, therapeutic interventions and outpatient visits were calculated. RESULTS: After 6 months of follow-up the data on 352 patients were analysed. Use of CE-MRA reduced the number of additional vascular-imaging procedures by 42% ((69-40)/69) and the specialists felt more confident about their therapeutic decisions. The diagnostic costs of all imaging studies taken together were Euro 167,- higher, on average, in the CE-MRA group (p < 0.001). However, after 6 months of follow-up, no statistically significant differences were found between the two groups with regard to the change in disease severity, the QOL, or the total costs (p > 0.05). CONCLUSION: Based on these findings, a specialist that replaces DUS by CE-MRA will feel more confident about taking a therapeutic decision and will feel less need for additional imaging. However, the diagnostic costs were higher with CE-MRA.

Cost-effectiveness of Chlamydia antibody tests in subfertile women.

BACKGROUND: For the evaluation of tubal function, Chlamydia antibody testing (CAT) has been introduced as a screening test. We compared six CAT screening strategies (five CAT tests and one combination of tests), with respect to their cost-effectiveness, by using IVF pregnancy rate as outcome measure. METHODS: A decision analytic model was developed based on a source population of 1715 subfertile women. The model incorporates hysterosalpingography (HSG), laparoscopy and IVF. To calculate IVF pregnancy rates, costs, effects, cost-effectiveness and incremental costs per effect of the six different CAT screening strategies were determined. RESULTS: pELISA Medac turned out to be the most cost-effective CAT screening strategy (15 075 per IVF pregnancy), followed by MIF Anilabsystems (15 108). A combination of tests (pELISA Medac and MIF Anilabsystems; 15 127) did not improve the cost-effectiveness of the single strategies. Sensitivity analyses showed that the results are robust for changes in the baseline values of the model parameters. CONCLUSIONS: Only small differences were found between the screening strategies regarding the cost-effectiveness, although pELISA Medac was the most cost-effective strategy. Before introducing a particular CAT test into clinical practice, one should consider the effects and consequences of the entire screening strategy, instead of only the diagnostic accuracy of the test used.

Performance of five serological chlamydia antibody tests in subfertile women.

BACKGROUND: Micro-immunofluorescence (MIF) is widely used for chlamydia antibody testing (CAT). Recently a species-specific MIF and three enzyme-linked immunosorbent assay (ELISA) tests have been introduced. We compared five commercially available CAT tests, using laparoscopy as a reference, and evaluated whether combinations of tests could improve the predictive value of CAT. METHODS: In a consecutive cohort of 315 subfertile women, results of the five CAT tests were correlated to findings at laparoscopy. Likelihood and odds ratios (OR) were calculated for single tests and for combinations of tests. RESULTS: Of the tests evaluated, MIF Labsystems had the best diagnostic performance (OR 15.7), while pELISA Medac (OR 8.2) was the best of the three ELISA tests. Stepwise logistic regression analysis showed that performance of MIF Labsystems could not be improved by adding a second test. Significant cross-reactivity with C. pneumoniae antibodies was found in all tests evaluated, except in pELISA Medac. CONCLUSIONS: In screening for tubal factor subfertility, MIF Labsystems was superior to the ELISA tests evaluated, and combining two CAT tests did not improve its predictive value. Economic analysis will show whether serial testing by pELISA Medac, and retesting positive samples by MIF Labsystems, is most cost-effective. In CAT, cross-reactivity with C. pneumoniae antibodies is still a major concern.

Home versus Office blood pressure MEasurements: Reduction of Unnecessary treatment Study: rationale and study design of the HOMERUS trial.

The Home versus Office MEasurements, Reduction of Unnecessary treatment Study (HOMERUS) is a multicentre prospective study, primarily designed to examine in subjects with mild to moderate hypertension whether treatment decisions based on home blood pressure measurements can lead to reduction in the use of antihypertensive drugs and the associated costs, compared to office blood pressure measurements. After inclusion, 360 patients are randomized to two groups. In one group, antihypertensive therapy is based on blood pressure measured in the outpatient clinic: the office pressure (OP) group. In the other group, antihypertensive therapy is based on home blood pressure measurements: the self-pressure (SP) group. All readings, both in OP and in SP, are obtained with the same validated oscillometric device, the Omron 705 CP. Treatment decisions are taken by an independent physician at the coordinating centre, who is unaware whether the patient belongs to the SP or OP group. Following a standardized treatment schedule, blood pressure is targeted at 120-139 mmHg for systolic and 80-89 mmHg for diastolic pressure. Patients are followed for 1 year. At the start and at the end of the study, ambulatory blood pressure measurements are obtained as a reference. Microalbuminuria and echocardiography are assessed to evaluate the possible development of target organ damage. It is expected that, at the end of the trial, patients in both groups will have the same blood pressure, at the expense of more medication in the OP group. Therefore, a cost-minimization analysis will be performed first. If short-term effects appear not to be comparable for OP and SP, a cost-effectiveness analysis will be performed to assess the value of the SP strategy in comparison to standard practice. In addition, medication compliance is recorded within random subgroups of the SP and OP groups by means of Medication Event Monitoring System (MEMS) V TrackCaps.