Comparison of generic and disease‐specific measures in their ability to detect differences in pressure ulcer clinical groups

Patient-reported outcomes can be included as end points in pressure ulcer (PU) intervention trials to provide information to inform decision-making and improve the lives of patients. However, the challenge for researchers and clinicians is identifying and choosing an appropriate instrument for each particular application that suits their research questions and clinical context. To provide researchers and clinicians with the information needed to inform choice of patient-reported outcome measures, we compared a generic and disease-specific measures’ ability to discriminate between clinical groups known to differ, and determined their responsiveness to change. We performed analyses on a subset of patients recruited to the PRESSURE 2 trial that completed the pressure ulcer quality of life instrument—prevention version (PU-QOL-P) and Short Form 12 Questionnaire (SF12) measures at baseline and 30-day posttreatment. Known-group validity and responsiveness-to-change analyses were conducted. The analysis sample consisted of 617 patients that completed both measures at baseline. Known-group validity revealed that some PU-QOL-P symptoms and function scales differentiated between people with category 2 PUs and those without PUs. A less meaningful pattern of results was observed for the SF12 scales, suggesting that the PU-QOL-P is more sensitive to differences between PU and non-PU populations. Responsiveness analysis revealed that the PU-QOL-P was more responsive in detecting disease severity than the SF12. The PU-QOL-P provides a standardized method for assessing PU-specific symptoms and functioning outcomes and is suitable for quantifying the benefits of PU interventions from the patient's perspective. Generic measures are useful for group comparisons of global quality of life domains. Choice of measure for each particular application should be determined by the purpose of the measurement and the information required

Comparison of generic and disease‐specific measures in their ability to detect differences in pressure ulcer clinical groups

Patient-reported outcomes can be included as end points in pressure ulcer (PU) intervention trials to provide information to inform decision-making and improve the lives of patients. However, the challenge for researchers and clinicians is identifying and choosing an appropriate instrument for each particular application that suits their research questions and clinical context. To provide researchers and clinicians with the information needed to inform choice of patient-reported outcome measures, we compared a generic and disease-specific measures’ ability to discriminate between clinical groups known to differ, and determined their responsiveness to change. We performed analyses on a subset of patients recruited to the PRESSURE 2 trial that completed the pressure ulcer quality of life instrument—prevention version (PU-QOL-P) and Short Form 12 Questionnaire (SF12) measures at baseline and 30-day posttreatment. Known-group validity and responsiveness-to-change analyses were conducted. The analysis sample consisted of 617 patients that completed both measures at baseline. Known-group validity revealed that some PU-QOL-P symptoms and function scales differentiated between people with category 2 PUs and those without PUs. A less meaningful pattern of results was observed for the SF12 scales, suggesting that the PU-QOL-P is more sensitive to differences between PU and non-PU populations. Responsiveness analysis revealed that the PU-QOL-P was more responsive in detecting disease severity than the SF12. The PU-QOL-P provides a standardized method for assessing PU-specific symptoms and functioning outcomes and is suitable for quantifying the benefits of PU interventions from the patient's perspective. Generic measures are useful for group comparisons of global quality of life domains. Choice of measure for each particular application should be determined by the purpose of the measurement and the information required

Mammographic surveillance in women younger than 50 years who have a family history of breast cancer: tumour characteristics and projected effect on mortality in the prospective, single-arm, FH01 study

Background Evidence supports a reduction in mortality from breast cancer with mammographic screening in the general population of women aged 40-49 years but the effect of family history is not clear We aimed to establish whether screening affects the disease stage and projected mortality of women younger than 50 years who have a clinically significant family history of breast cancerMethods In the single arm FH01 study, women at intermediate familial risk who were younger than 50 years were enrolled from 76 centres in the UK and received yearly mammography Women with BRCA mutations were not explicitly excluded but would be rare in this group To compare the FH01 cohort with women not receiving screening two external comparison groups were used the control group of the UK Age Trial (106971 women aged 40-42 years at recruitment from the general population [ie average risk] followed up for 10 years), and a Dutch study of women with a family history of breast cancer (cancer cases aged 25-77 years diagnosed 1980-2004) Study endpoints were size, node status and histological grade of invasive tumours and estimated mortality calculated from the Nottingham prognostic index (NPI) score, and adjusted for differences in underlying risk between the FH01 cohort and the control group of the UK Age Trial This study is registered with the National Research Register number N0484114809Findings 6710 women were enrolled between Jan 16 2003 and Feb 28,2007, and received yearly mammography for a mean of 4 years (SD 2) up until Nov 30,2009 surveillance and reporting of cancers is still underway 136 women were diagnosed with breast cancer 105 (77%) at screening 28 (21%) symptomatically in the interval between screening events and three (2%) symptomatically after failing to attend their latest mammogram Invasive tumours in the FH01 study were significantly smaller (p=0 0094) less likely to be node positive (p=0 0083) and of more favourable grade (p=0 0072) than were those in the control group of the UK Age Trial and were significantly less likely to be node positive than were tumours in the Dutch study (p=0 012) Mean NPI score was significantly lower in the FH01 cohort than in the control group of the UK Age Trial (p=0 00079) or the Dutch study (p<0 0001) After adjustment for underlying risk predicted 10 year mortality was significantly lower in the FH01 cohort (1 10%) than in the control group of the UK Age Trial (1 38%) with relative risk of 0 80 (95% CI 0 66-0 96 p=0 022)Interpretation Yearly mammography in women with a medium familial risk of breast cancer is likely to be effective in prevention of deaths from breast cance