Association of low general health status, measured prospectively by Euroqol EQ5D, with osteoporosis, independent of a history of prior fracture.

OBJECTIVES: There have been no studies of generic health-related quality of life (HR-QOL) measured prospectively, in patients referred for bone mass measurement. The aim of this study was to examine the relationship between HR-QOL, measured before DXA scanning was undertaken, and bone mineral density (BMD). Comparison of HR-QOL with the age- and sex-matched general population was also made. DESIGN: HR-QOL questionnaires were completed by patients who were being entered into a randomized, prospective, parallel group trial to assess the impact of direct access DXA scanning (DADS) versus referral to a hospital consultant, upon clinical decision making by general practitioners (GPs) (Dhillon et al., Osteoporos Int 14:326-333, 2003). HR-QOL questionnaires were completed prior to both randomization and DXA scanning. PARTICIPANTS: 325 patients from 18 representative general practices of a total of 77 in the city of Edinburgh. Patients had been referred by their GPs who had access to national guidelines on the identification of patients at high risk of osteoporosis. OUTCOME MEASURES: Generic HR-QOL was measured using Euroqol (EQ5D). This provides a profile of self-reported problems in five dimensions (EQ5D(profile)), health utility (EQ5D(utility)), and a visual analogue global self-rated health assessment (EQ5D(vas)). RESULTS: Odds ratios (ORs) for any self-reported problems on EQ5D(profile) were higher in patients with osteoporosis than those without, and compared with the general population. Age-adjusted mean (SD) EQ5D(utility )was significantly lower in patients with osteoporosis than in those without (0.65 [0.28] vs 0.76 [0.27]; p< 0.01), but the difference lessened with advancing age. Age-adjusted mean (SD) EQ5D(vas) was significantly reduced in patients with compared with no osteoporosis (68 [20] vs 76 [16]; p<0.01). There were no such differences in patients with a history of prior fracture compared with those without a history of prior fracture. CONCLUSIONS: Female patients with osteoporosis have reduced generic HR-QOL compared with the age-matched female general population, irrespective of a history of prior fracture. The causal relationship between osteoporosis and HR-QOL, if any, is unclear. Further studies are needed to define this relationship and to determine whether treatment of osteoporosis has a beneficial effect on HR-QOL independent of fracture risk.

Dose escalation of parenteral methotrexate in active rheumatoid arthritis that has been unresponsive to conventional doses of methotrexate: a randomized, controlled trial.

OBJECTIVE: To examine whether dose escalation of intramuscular (IM) methotrexate (MTX) up to 45 mg/week improves disease control in patients who have active rheumatoid arthritis (RA) despite receiving conventional doses (15 mg/week) of IM MTX, and to obtain preliminary data on patient tolerability and adverse effects of higher doses of IM MTX. METHODS: Patients >18 years of age who had active RA, defined as a European League Against Rheumatism (EULAR) Disease Activity Score in 28 joints (DAS28) of >3.2, and who had received 15-20 mg/week of oral MTX for at least 2 months were switched (week 0) to 15 mg/week of IM MTX for 6 weeks. Patients whose DAS28 remained >3.2 at both week 4 and week 6 were randomized, in a double-blind manner, either to continue to receive 15 mg/week IM MTX with monthly placebo escalation or to receive escalating doses of IM MTX monthly up to 45 mg/week. The dose of MTX or placebo was escalated every 4 weeks if the DAS28 was >2.5. Safety assessments and determination of the DAS28 were performed every 2 weeks and monthly, respectively. Disease activity parameters from the American College of Rheumatology (ACR) core disease activity set and health status as recorded on the Medical Outcomes Study Short-Form 12 were determined at baseline (week 0) and final assessment (week 22). The primary outcome was the percentage of patients in each group achieving a target DAS28 of <3.2. Secondary outcomes comprised the percentage of patients whose DAS28 improved by >1.2, the percentage of patients achieving a 20% improvement in the ACR core disease activity measures (ACR20), and the percentage of patients achieving a good response, a moderate response, or no response in accordance with the EULAR response criteria. RESULTS: Sixty-four patients were eligible for entry and were switched from oral MTX to 15 mg/week IM MTX. At baseline, the mean +/- SD DAS28 was 5.6 +/- 0.88; after 6 weeks of IM MTX, the DAS28 had improved by a mean of 0.42 (95% confidence interval [95% CI] 0.15-0.69). At 6 weeks, 54 patients still had a DAS28 of >3.2 and were therefore eligible for randomization. By 22 weeks, 1 patient (3.7%) in each group achieved the primary outcome of a DAS28 <3.2 (95% CI for the difference between the groups -15% to +15%). Five patients (18.5%) in each group showed an improvement of >1.2 in the DAS28 (95% CI for the difference between the groups -18% to +18%). One patient (3.7%) in each group achieved an ACR20 response, but none achieved a good response as defined by the EULAR response criteria. One patient in each group had a serious adverse reaction; minor adverse reactions were more frequently reported in the dose escalation group. CONCLUSION: Switching from oral to parenteral MTX 15 mg/week results in a minor improvement in disease control. For patients with active RA receiving 15 mg/week IM MTX, increasing the dose up to 45 mg/week does not improve disease control. Higher doses of IM MTX were generally well tolerated and not associated with an increase in serious adverse reactions to the drug.

Impact of a nurse-led counselling service on quality of life in patients with inflammatory bowel disease.

AIM: Health related quality of life is impaired in patients suffering from inflammatory bowel disease. Although counselling directed towards physical and psychological morbidity is assumed to improve health related quality of life, this has never been demonstrated. METHODS: Physical and psychological well-being were assessed using questionnaires administered to 100 out-patients in the United Kingdom suffering from inflammatory bowel disease, 50 subjects not suffering from inflammatory bowel disease and a disease control group comprising 28 patients with psoriatic arthritis. A specific nurse led counselling package was given to half the inflammatory bowel disease group and health related quality of life was assessed at baseline, 6 and 12 months. RESULTS: Inflammatory bowel disease and psoriatic arthritic patients had a range of physical disease activity, although none were severely ill during the course of the study. Medical therapy was similar in both groups throughout the duration of the trial. The mean Short Form 36 (SF-36) scores for mental health were low in inflammatory bowel disease patients; 62.9 +/- 9.1 (SD) in ulcerative colitis, 60 +/- 9.8 (SD) in Crohn's disease, compared with 72.4 +/- 7.2 (SD) in healthy controls (P < 0.05). Mean SF-36 scores for social function were also reduced in Crohn's disease patients; 68.4 +/- 10.1 (SD) in Crohn's disease, compared with 87 +/- 10.1 (SD) in healthy controls (P < 0.05). As expected, the mean SF-36 scores in psoriatic arthritic patients were significantly low 61.9 +/- 1.5 (SD) compared with 82.4 +/- 14 (SD) in healthy controls (P < 0.05). Crohn's disease patients were significantly more anxious than the other groups, mean HAD score was 10 +/- 3.7 (SD) in Crohn's disease patients and 6.86 +/- 3.5 (SD) in healthy volunteers (P < 0.05), although mean HAD scores for depression were similar in all groups. Maladaptive coping mechanisms were present in a significant proportion of Crohn's disease patients. At follow-up all aspects of psychological morbidity returned to the normal range in the Crohn's disease patients without significant change in the mean physical disease index. CONCLUSION: Health related quality of life can be improved over 6 months by provision of a nurse led counselling service but the effects are not sustained for 12 months.