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Biomedical subjects

Cynthia Iglesias

Publications and source records attributed to Cynthia Iglesias.

4 recordsLinked to original sources

Randomised, controlled trial of alternating pressure mattresses compared with alternating pressure overlays for the prevention of pressure ulcers: PRESSURE (pressure relieving support surfaces) trial.

OBJECTIVE: To compare whether differences exist between alternating pressure overlays and alternating pressure mattresses in the development of new pressure ulcers, healing of existing pressure ulcers, and patient acceptability. DESIGN: Pragmatic, open, multicentre, randomised controlled trial. SETTING: 11 hospitals in six NHS trusts. PARTICIPANTS: 1972 people admitted to hospital as acute or elective patients. INTERVENTIONS: Participants were randomised to an alternating pressure mattress (n = 982) or an alternating pressure overlay (n = 990). MAIN OUTCOME MEASURES: The proportion of participants developing a new pressure ulcer of grade 2 or worse; time to development of new pressure ulcers; proportions of participants developing a new ulcer within 30 days; healing of existing pressure ulcers; and patient acceptability. RESULTS: Intention to treat analysis found no difference in the proportions of participants developing a new pressure ulcer of grade 2 or worse (10.7% overlay patients, 10.3% mattress patients; difference 0.4%, 95% confidence interval--2.3% to 3.1%, P = 0.75). More overlay patients requested change owing to dissatisfaction (23.3%) than mattress patients (18.9%, P = 0.02). CONCLUSION: No difference was found between alternating pressure mattresses and alternating pressure overlays in the proportion of people who develop a pressure ulcer. TRIAL REGISTRATION: ISRCTN 78646179.

Adult↗

Pressure relieving support surfaces (PRESSURE) trial: cost effectiveness analysis.

OBJECTIVE: To assess the cost effectiveness of alternating pressure mattresses compared with alternating pressure overlays for the prevention of pressure ulcers in patients admitted to hospital. DESIGN: Cost effectiveness analysis carried out alongside the pressure relieving support surfaces (PRESSURE) trial; a multicentre UK based pragmatic randomised controlled trial. SETTING: 11 hospitals in six UK NHS trusts. PARTICIPANTS: Intention to treat population comprising 1971 participants. MAIN OUTCOME MEASURES: Kaplan Meier estimates of restricted mean time to development of pressure ulcers and total costs for treatment in hospital. RESULTS: Alternating pressure mattresses were associated with lower overall costs (283.6 pounds sterling per patient on average, 95% confidence interval--377.59 pounds sterling to 976.79 pounds sterling) mainly due to reduced length of stay in hospital, and greater benefits (a delay in time to ulceration of 10.64 days on average,--24.40 to 3.09). The differences in health benefits and total costs for hospital stay between alternating pressure mattresses and alternating pressure overlays were not statistically significant; however, a cost effectiveness acceptability curve indicated that on average alternating pressure mattresses compared with alternating pressure overlays were associated with an 80% probability of being cost saving. CONCLUSION: Alternating pressure mattresses for the prevention of pressure ulcers are more likely to be cost effective and are more acceptable to patients than alternating pressure overlays.

Adult↗

Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care.

OBJECTIVE: To assess whether supplementation with calcium and cholecaliferol (vitamin D3) reduces the risk of fracture in women with one or more risk factors for fracture of the hip. DESIGN: Pragmatic open randomised controlled trial. SETTING: Practice nurse led clinics in primary care. PARTICIPANTS: 3314 women aged 70 and over with one or more risk factors for hip fracture: any previous fracture, low body weight (< 58 kg), smoker, family history of hip fracture, or fair or poor self reported health. INTERVENTION: Daily oral supplementation using 1000 mg calcium with 800 IU cholecaliferol and information leaflet on dietary calcium intake and prevention of falls, or leaflet only (control group). MAIN OUTCOME MEASURES: Primary outcome measure was all clinical fractures and secondary outcome measures were adherence to treatment, falls, and quality of life (measured with the SF-12). RESULTS: 69% of the women who completed the follow-up questionnaire at 24 months were still taking supplements (55% with inclusion of randomised participants known to be alive). After a median follow-up of 25 months (range 18 to 42 months), clinical fracture rates were lower than expected in both groups but did not significantly differ for all clinical fractures (odds ratio for fracture in supplemented group 1.01, 95% confidence interval 0.71 to 1.43). The odds ratio for hip fracture was 0.75 (0.31 to 1.78). The odds of a woman having a fall at six and 12 months was 0.99 and 0.98, respectively. Quality of life did not significantly differ between the groups. CONCLUSION: We found no evidence that calcium and vitamin D supplementation reduces the risk of clinical fractures in women with one or more risk factors for hip fracture. Registration ISRCTN26118436, controlled trials registry.

Administration, Oral↗

Randomized clinical trial comparing 2 support surfaces: results of the Prevention of Pressure Ulcers Study.

OBJECTIVE: To determine whether a viscoelastic polymer (energy absorbing) foam mattress was superior to a standard hospital mattress for pressure ulcer prevention and to analyze the cost-effectiveness in comparison with standard hospital mattresses. DESIGN: Unblinded, randomized, prospective trial. SETTING: Elderly acute care, rehabilitation, and orthopedic wards at 3 hospitals in the United Kingdom. PARTICIPANTS: 1168 patients at risk of developing pressure ulcers (Waterlow score, 15 to 20), with a median age of 83 years (25th to 75th percentile range, 79-87). INTERVENTIONS: Participants were allocated to either the experimental equipment (CONFOR-Med mattress/cushion combination) or a standard mattress/cushion combination; all were given standard nursing care. Pressure areas were observed daily. MAIN OUTCOME MEASURE: Development of nonblanching erythema. RESULTS: A significant decrease in the incidence of blanching erythema (26.3% to 19.9%; P =.004) and a nonsignificant decrease in the incidence of nonblanching erythema occurred in participants allocated to the experimental equipment. However, when the survival curve plots were analyzed at 7 days, both categories showed statistically significant decreases (P =.0015 and P =.042, respectively). Participants on standard equipment had a relative odds ratio of 1.36 (95% confidence interval [CI], 1.10-1.69) for developing blanching erythema or worse and 1.46 (95% CI, 0.90-1.82) for developing nonblanching erythema or worse. To prevent nonblanching erythema, the number needed to treat (NNT) was 41.9 (95% CI, -82.6-15.3). To prevent any erythema (blanching or nonblanching), the NNT was 11.5 (95% CI, 41.6-9.3). Participants with blanching or nonblanching erythema were significantly less mobile than participants with normal skin and more likely to have worsening mobility (P <.001). For participants with similar pressure ulcer status, mattress type was not associated with difference in mobility. CONCLUSIONS: Regardless of prevention routine, pressure ulcers occur. In this study, the experimental equipment showed statistical significance to standard equipment for prevention of blanching erythema; significance was not achieved for nonblanching erythema. Trend and survival analysis show that a larger study is required to determine whether this nonsignificant difference is genuine.

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