Development and use of health outcome descriptors: a guideline development case study.

BACKGROUND: During healthcare guideline development, panel members often have implicit, different definitions of health outcomes that can lead to misunderstandings about how important these outcomes are and how to balance benefits and harms. McMaster GRADE Centre researchers developed 'health outcome descriptors' for standardizing descriptions of health outcomes and overcoming these problems to support the European Commission Initiative on Breast Cancer (ECIBC) Guideline Development Group (GDG). We aimed to determine which aspects of the development, content, and use of health outcome descriptors were valuable to guideline developers. METHODS: We developed 24 health outcome descriptors related to breast cancer screening and diagnosis for the European Commission Breast Guideline Development Group (GDG). Eighteen GDG members provided feedback in written format or in interviews. We then evaluated the process and conducted two health utility rating surveys. RESULTS: Feedback from GDG members revealed that health outcome descriptors are probably useful for developing recommendations and improving transparency of guideline methods. Time commitment, methodology training, and need for multidisciplinary expertise throughout development were considered important determinants of the process. Comparison of the two health utility surveys showed a decrease in standard deviation in the second survey across 21 (88%) of the outcomes. CONCLUSIONS: Health outcome descriptors are feasible and should be developed prior to the outcome prioritization step in the guideline development process. Guideline developers should involve a subgroup of multidisciplinary experts in all stages of development and ensure all guideline panel members are trained in guideline methodology that includes understanding the importance of defining and understanding the outcomes of interest.

Mammography in females with an implanted medical device: impact on image quality, pain and anxiety.

OBJECTIVE: To assess the image quality of mammograms in females with an implanted medical device (IMD), to evaluate pain and anxiety during mammography in these females and to investigate the experience of radiographers. METHODS: Image quality was evaluated by two radiographers and one radiologist in the images of females with an IMD participating in the Dutch screening programme (clients). Pain and anxiety were scored using a Numeric Rating Scale in both clients visiting a screening organization and patients from the Isala Hospital, Zwolle. Experience of screening radiographers was collected with a questionnaire. RESULTS: Images of the breast with IMD showed reduced contrast in craniocaudal (CC) and mediolateral-oblique (MLO) views [by both the radiographers and radiologist (range: 11-29%)], less projected breast tissue [only radiographers; CC lateral side: 25.5%, 95% confidence interval (CI): 18.7-32.2] and reduced projection of the pectoral muscle (only radiographers; MLO width pectoral muscle: 31.5%, 95% CI: 24.4-38.7). Clients experienced more pain and anxiety during mammography in the breast with IMD compared to the breast without IMD in the breast (pain difference CC: 0.48 ± 0.16, p = 0.003; pain difference MLO: 0.46 ± 0.16, p = 0.004; anxiety difference 1.30 ± 0.22; p < 0.001). Patients experienced more pain (1.05 ± 0.12; p < 0.001) and anxiety (1.22 ± 0.15; p < 0.001) after placement of IMD. Radiographers are more cautious, more anxious and use less compression during mammography of breasts with IMD. CONCLUSION: Image quality in a breast with an IMD could be improved by projecting more breast tissue on the mammogram, thereby including (part of) the IMD between the paddles, if required. In addition, radiographers should pay sufficient attention to reducing discomfort both before and during the screening examination. ADVANCES IN KNOWLEDGE: Little is known about the quality of mammography in females with an IMD or how these females and radiographers experience the screening examination. The results of our study showed that having an IMD could result in a suboptimal mammogram and increased discomfort.

Mammographic positioning quality of newly trained versus experienced radiographers in the Dutch breast cancer screening programme.

PURPOSE: Our purpose was to compare mammographic positioning quality of new (NR) versus experienced screening radiographers (ER) in the Netherlands. METHODS AND MATERIALS: Before starting to work in breast screening, NR must complete an education programme including a theoretical course (four days), practical training (six weeks), and a portfolio-review of 50 mammographic screening examinations performed by the radiographer. Furthermore, Dutch screening has an extensive system of quality assurance, including an audit-review of positioning quality of mammograms by ER. We analysed 13,520 portfolio views (NR) and 14,896 audit views (ER) based on pre-specified criteria, e.g., depiction of inframammary angle. RESULTS: Overall positioning was more adequate for NR than ER (CC views: 97% versus 86%, p = 0.00; MLO views: 92% versus 84%, p = 0.00). NR scored better for most of the CC-criteria and showed, for instance, less folds (inadequate: 10% versus 16%, p = 0.00). In contrast, NR encountered more difficulties for MLO views in, for example, depiction of infra-mammary angle (inadequate: 38% versus 34%, p = 0.00). Overall, mammograms from NR were more often considered adequate, because of less severe errors. CONCLUSION: NR perform better than ER in overall positioning technique. These results stress the need for continuous monitoring and training in breast screening programmes to keep positioning skills up to date. KEY POINTS: • We evaluated positioning quality of new and experienced Dutch screening radiographers. • New radiographers outperform their experienced colleagues in mammographic positioning quality. • New radiographers make less severe errors compared to experienced colleagues. • There is a need for a continuous individual monitoring and feedback system.

Comparison of a flexible versus a rigid breast compression paddle: pain experience, projected breast area, radiation dose and technical image quality.

PURPOSE: To compare pain, projected breast area, radiation dose and image quality between flexible (FP) and rigid (RP) breast compression paddles. METHODS: The study was conducted in a Dutch mammographic screening unit (288 women). To compare both paddles one additional image with RP was made, consisting of either a mediolateral-oblique (MLO) or craniocaudal-view (CC). Pain experience was scored using the Numeric Rating Scale (NRS). Projected breast area was estimated using computer software. Radiation dose was estimated using the model by Dance. Image quality was reviewed by three radiologists and three radiographers. RESULTS: There was no difference in pain experience between both paddles (mean difference NRS: 0.08 ± 0.08, p = 0.32). Mean radiation dose was 4.5 % lower with FP (0.09 ± 0.01 p = 0.00). On MLO-images, the projected breast area was 0.79 % larger with FP. Paired evaluation of image quality indicated that FP removed fibroglandular tissue from the image area and reduced contrast in the clinically relevant retroglandular area at chest wall side. CONCLUSIONS: Although FP performed slightly better in the projected breast area, it moved breast tissue from the image area at chest wall side. RP showed better contrast, especially in the retroglandular area. We therefore recommend the use of RP for standard MLO and CC views.