2,493 research outputs found
An evidence-based self-management package for urinary incontinence in older women: a mixed methods feasibility study
Background
Urinary incontinence (UI) is a distressing condition that limits women’s quality of life and places a heavy burden on health care services. Behavioural treatments are recommended as a first-line treatment. An evidence-based self-management package was developed following the Medical Research Council (MRC) framework for complex interventions. This study aimed to evaluate the feasibility and acceptability of the intervention.
Methods
A mixed-methods approach was undertaken, namely a randomised controlled feasibility study with nested qualitative study. Fifty women aged 55 or over living with UI, recruited from community centres were randomly assigned to either a 3-month course with the package with a support session or a control group to receive the same package only 3 months later. Principal outcome measures were: self-reported quality of life, UI severity, self-efficacy and psychological status. Analysis of covariance was undertaken to estimate within- and between- group changes for all outcomes. Acceptability was explored using individual interviews at follow-up.
Results
Fifty women were randomised (24 to intervention, 26 to control); mean age of 69.7 (±9.1) years and mean UI frequency 2.2 (±2.2) episodes/day at baseline. Overall, 49 women (98%) completed 3-month follow-up (24 in the intervention, 25 in the control). A positive trend was detected in the impact of UI on their personal relationships (− 3.89, p = 0.088), symptom severity (− 1.77, p = 0.025), UI symptoms scale (− 1.87, p = 0.031) and anxiety status (− 2.31, p = 0.001), respectively. Changes in quality of life and self-efficacy did not differ significantly between groups. Majority of women (71%) in the intervention group reported subjective improvement after 3 months. Spearman correlation coefficient was 0.43 (p < 0.05) between their subjective perception of change and self-efficacy. Women perceived the package being acceptable and described that the package had the potential to increase their knowledge and confidence to manage symptoms and improve quality of life.
Conclusions
The study demonstrated that the self-management package is feasible and acceptable for older women with UI. Further studies are needed with a large sample size in clinical settings to evaluate the effectiveness of this package
Pressure relieving support surfaces (PRESSURE) trial : cost effectiveness analysis
Objective To assess tire 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 pound per patient on average, 95% confidence interval -377.59 pound to. 976.79) pound 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 air 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
Cost effectiveness analysis of larval therapy for leg ulcers
Objective: To assess the cost effectiveness of larval therapy compared with hydrogel in the management of leg ulcers. Design: Cost effectiveness and cost utility analyses carried out alongside a pragmatic multicentre, randomised, open trial with equal randomisation. Population: Intention to treat population comprising 267 patients with a venous or mixed venous and arterial ulcers with at least 25% coverage of slough or necrotic tissue. Interventions: Patients were randomly allocated to debridement with bagged larvae, loose larvae, or hydrogel. Main outcome measure: The time horizon was 12 months and costs were estimated from the UK National Health Service perspective. Cost effectiveness outcomes are expressed in terms of incremental costs per ulcer-free day (cost effectiveness analysis) and incremental costs per quality adjusted life years (cost utility analysis). Results: The larvae arms were pooled for the main analysis. Treatment with larval therapy cost, on average, 96.70 pound ((sic)109.61; $140.57) more per participant per year (95% confidence interval -491.9 pound to 685.8) pound than treatment with hydrogel. Participants treated with larval therapy healed, on average, 2.42 days before those in the hydrogel arm (95% confidence interval -0.95 to 31. 91 days) and had a slightly better health related quality of life, as the annual difference in QALYs was 0.011 (95% confidence interval -0.067 to 0.071). However, none of these differences was statistically significant. The incremental cost effectiveness ratio for the base case analysis was estimated at 8826 pound per QALY gained and 40 pound per ulcer-free day. Considerable uncertainty surrounds the outcome estimates. Conclusions: Debridement of sloughy or necrotic leg ulcers with larval therapy is likely to produce similar health benefits and have similar costs to treatment with hydrogel. Trial registration: Current Controlled Trials ISRCTN55114812 and National Research Register N0484123692
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Offloading devices for the prevention of heel pressure ulcers: a realist evaluation
Background
Heel pressure ulcers can cause pain, reduce mobility, lead to longer hospital stays and in severe cases can lead to sepsis, amputation, and death. Offloading boots are marketed as heel pressure ulcer prevention devices, working by removing pressure to the heel, yet there is little good quality evidence about their clinical effectiveness. Given that evidence is not guiding use of these devices, this study aims to explore, how, when, and why these devices are used in hospital settings.
Objective
To explore how offloading devices are used to prevent heel pressure ulcers, for whom and in what circumstances.
Methods
A realist evaluation was undertaken to explore the contexts, mechanisms, and outcomes that might influence how offloading devices are implemented and used in clinical practice for the prevention of heel pressure ulcers in hospitals. Eight Tissue Viability Nurse Specialists from across the UK (England, Wales, and Northern Ireland) were interviewed. Questions sought to elicit whether, and in what ways, initial theories about the use of heel pressure ulcers fitted with interviewee's experiences.
Results
Thirteen initial theories were refined into three programme theories about how offloading devices are used by nurses ‘proactively’ to prevent heel pressure ulcers, ‘reactively’ to treat and minimise deterioration of early-stage pressure ulcers, and patient factors that influence how these devices are used.
Conclusions
Offloading devices were used in clinical practice by all the interviewees. It was viewed that they were not suitable to be used by every patient, at every point in their inpatient journey, nor was it financially viable. However, the interviewees thought that identifying suitable ‘at risk’ patient groups that can maintain use of the devices could lead to proactive and cost-effective use of the devices.
This understanding of the contexts and mechanisms that influence the effective use of offloading devices has implications for clinical practice and design of clinical trials of offloading devices.
Tweetable abstract
How, for whom, and in what circumstances do offloading devices work to prevent heel pressure ulcers? Tissue viability nurses' perspectives
The effect of multi-layer bandage on the interface pressure applied by compression bandages
Medical compression bandages are widely used in the
treatment of chronic venous disorder. In order to design effective
compression bandages, researchers have attempted to describe the
interface pressure applied by multi-layer bandages using mathematical
models. This paper reports on the work carried out to
compare and validate the mathematical models used to describe the
interface pressure applied by multi-layer bandages. Both analytical
and experimental results showed that using simple multiplication
of a number of bandage layers with the pressure applied by one
layer of bandage or ignoring the increase in the limb radius due to
former layers of bandage will result in overestimating the pressure.
Experimental results showed that the mathematical models, which
take into consideration the increase in the limb radius due to former
bandage layers, are more accurate than the one which does not
Comparative effectiveness of heel-specific medical devices for the prevention of heel pressure ulcers: a systematic review
Background
Pressure ulcers (PUs) impact on patient's quality of life and are costly for healthcare providers. Heels are a particular concern due to specific risk factors. Relative effectiveness of medical devices, e.g., dressings, off-loading devices, heel cushioning devices, to reduce PU development is unknown.
Methods
Systematic review of the effectiveness of heel-specific medical devices for the prevention of heel PU (HPU)s. Database searches were performed from inception to June 2021 for RCTs. The primary outcome was incidence of new HPUs. Trials were assessed for risk of bias and data analysed with risk ratios, mean difference or hazard ratios as appropriate.
Results
Fifteen RCTs (4724 participants) were identified.
Dressings, as constant low pressure (CLP) devices vs standard care: eight trials (very low quality) showed no-significant difference in effectiveness (RR 0.31, 95%CI 0.10 to 1.01).
Off-loading devices vs standard care: three trials (low quality), showed significant reduction in development of Category≥1 HPUs (RR 0.20, 95%CI 0.05 to 0.80) two trials (medium quality), showed significant reduction in development of Category≥2 HPUs (RR 0.08, 95%CI 0.01 to 0.67).
Comparisons between off-loading devices: two trials (low quality) showed no clear difference in HPU incidence.
In a paediatric post-surgical population, one trial of off-loading device and one of a dressing (CLP device), both versus standard care, showed no clear difference in HPU incidence (RR 0.19 95%CI 0.02 to 1.55 and RR 0.89 95%CI 0.56 to 1.42 respectively).
Conclusions
Off-loading devices may reduce HPU incidence, from low-quality evidence. There is insufficient evidence to suggest that dressings reduce HPU incidence
Larval therapy for leg ulcers (VenUS II) : randomised controlled trial
Objective To compare the clinical effectiveness of larval therapy with a standard debridement technique (hydrogel) for sloughy or necrotic leg ulcers. Design Pragmatic, three armed randomised controlled trial. Setting Community nurse led services, hospital wards, and hospital outpatient leg ulcer clinics in urban and rural settings, United Kingdom. Participants 267 patients with at least one venous or mixed venous and arterial ulcer with at least 25% coverage of slough or necrotic tissue, and an ankle brachial pressure index of 0.6 or more. Interventions Loose larvae, bagged larvae, and hydrogel. Main outcome measures The primary outcome was time to healing of the largest eligible ulcer. Secondary outcomes were time to debridement, health related quality of life (SF-12), bacterial load, presence of meticillin resistant Staphylococcus aureus, adverse events, and ulcer related pain (visual analogue scale, from 0 mm for no pain to 150 mm for worst pain imaginable). Results Time to healing was not significantly different between the loose or bagged larvae group and the hydrogel group (hazard ratio for healing using larvae v hydrogel 1.13, 95% confidence interval 0.76 to 1.68; P=0.54). Larval therapy significantly reduced the time to debridement (2.31, 1.65 to 3.2; P<0.001). Health related quality of life and change in bacterial load over time were not significantly different between the groups. 6.7% of participants had MRSA at baseline. No difference was found between larval therapy and hydrogel in their ability to eradicate MRSA by the end of the debridement phase (75% (9/12) v 50% (3/6); P=0.34), although this comparison was underpowered. Mean ulcer related pain scores were higher in either larvae group compared with hydrogel (mean difference in pain score: loose larvae v hydrogel 46.74 (95% confidence interval 32.44 to 61.04), P<0.001; bagged larvae v hydrogel 38.58 (23.46 to 53.70), P<0.001). Conclusions Larval therapy did not improve the rate of healing of sloughy or necrotic leg ulcers or reduce bacterial load compared with hydrogel but did significantly reduce the time to debridement and increase ulcer pain. Trial registration Current Controlled Trials ISRCTN55114812 and National Research Register N0484123692
Exploring the role of pain as an early predictor of category 2 pressure ulcers: a prospective cohort study
Objective To explore pressure area related pain as a predictor of category ≥2 pressure ulcer (PU) development.
Design Multicentre prospective cohort study.
Setting UK hospital and community settings.
Participants inclusion Consenting acutely ill patients aged ≥18 years, defined as high risk (Braden bedfast/chairfast AND completely immobile/very limited mobility; pressure area related pain or; category 1 PU).
Exclusion Patients too unwell, unable to report pain, 2 or more category ≥2 PUs.
Follow-up Twice weekly for 30 days.
Primary and secondary outcome measures Development and time to development of one or more category ≥2 PUs.
Results Of 3819 screened, 1266 were eligible, 634 patients were recruited, 32 lost to follow-up, providing a 602 analysis population. 152 (25.2%) developed one or more category ≥2 PUs. 464 (77.1%) patients reported pressure area related pain on a healthy, altered or category 1 skin site of whom 130 (28.0%) developed a category ≥2 PU compared with 22 (15.9%) of those without pain. Full stepwise variable selection was used throughout the analyses. (1) Multivariable logistic regression model to assess 9 a priori factors: presence of category 1 PU (OR=3.25, 95% CI (2.17 to 4.86), p<0.0001), alterations to intact skin (OR=1.98, 95% CI (1.30 to 3.00), p=0.0014), pressure area related pain (OR=1.56, 95% CI (0.93 to 2.63), p=0.0931). (2) Multivariable logistic regression model to account for overdispersion: presence of category 1 PU (OR=3.20, 95% CI (2.11 to 4.85), p<0.0001), alterations to intact skin (OR=1.90, 95% CI (1.24 to 2.91), p=0.0032), pressure area related pain (OR=1.85, 95% CI (1.07 to 3.20), p=0.0271), pre-existing category 2 PU (OR=2.09, 95% CI (1.35 to 3.23), p=0.0009), presence of chronic wound (OR=1.66, 95% CI (1.06 to 2.62), p=0.0277), Braden activity (p=0.0476). (3) Accelerated failure time model: presence of category 1 PU (AF=2.32, 95% CI (1.73 to 3.12), p<0.0001), pressure area related pain (AF=2.28, 95% CI (1.59 to 3.27), p<0.0001). (4) 2-level random-intercept logistic regression model: skin status which comprised 2 levels (versus healthy skin); alterations to intact skin (OR=4.65, 95% CI (3.01 to 7.18), p<0.0001), presence of category 1 PU (OR=17.30, 95% CI (11.09 to 27.00), p<0.0001) and pressure area related pain (OR=2.25, 95% CI (1.53 to 3.29), p<0.0001).
Conclusions This is the first study to assess pain as a predictor of category ≥2 PU development. In all 4 models, pain emerged as a risk factor associated with an increased probability of category ≥2 PU development
Bioassay-guided isolation and identification of antimicrobial compounds from thyme essential oil by means of overpressured layer chromatography, bioautography and GC-MS
A simple method is described for efficient isolation of compounds having an antibacterial effect.
Two thyme (Thymus vulgaris) essential oils, obtained from the market, were chosen as
prospective materials likely to feature several bioactive components when examined by thin layer
chromatography coupled with direct bioautography as a screening method. The newly developed
infusion overpressured layer chromatographic separation method coupled with direct
bioautography assured that only the active components were isolated by means of overrun
overpressured layer chromatography with online detection and fractionation. Each of the 5
collected fractions represented one of the five antimicrobial essential oil components designated
at the screening. The purity and the activity of the fractions were confirmed with chromatography
coupled various detection methods (UV, vanillin-sulphuric acid reagent, direct bioautography).
The antibacterial components were identified with GC-MS as thymol, carvacrol, linalool, diethylphthalate,
and alpha-terpineol. The oil component diethyl-phthalate is an artificial compound,
used as plasticizer or detergent bases in the industry. Our results support that exploiting its
flexibility and the possible hyphenations, overpressured layer chromatography is especially
attractive for isolation of antimicrobial components from various matrixes
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