Does participating in a clinical trial affect subsequent nursing management? Post-trial care for participants recruited to the INTACT pressure ulcer prevention trial: A follow-up study

BackgroundParticipation in a clinical trial is believed to benefit patients but little is known about the post-trial effects on routine hospital-based care.ObjectivesTo describe (1) hospital-based, pressure ulcer care-processes after patients were discharged from a pressure ulcer prevention, cluster randomised controlled trial; and (2) to investigate if the trial intervention had any impact on subsequent hospital-based care.MethodsWe conducted a retrospective analysis of 133 trial participants who developed a pressure ulcer during the clinical trial. We compared outcomes and care processes between participants who received the pressure ulcer prevention intervention and those in the usual care, control group. We also compared care processes according to the pressure ulcer stage.ResultsA repositioning schedule was reported for 19 (14.3%) patients; 33 (24.8%) had a dressing applied to the pressure ulcer; 17 (12.8) patients were assessed by a wound care team; and 20 (15.0%) were seen by an occupational therapist. Patients in the trial’s intervention group were more likely to have the presence of a pressure ulcer documented in their chart (odds ratio (OR) 8.18, 95% confidence intervals (CI) 3.64–18.36); to be referred to an occupational therapist OR 0.92 (95% CI 0.07; 0.54); to receive a pressure relieving device OR 0.31 (95% CI 0.14; 0.69); or a pressure relieving mattress OR 0.44 (95% CI 0.20; 0.96). Participants with Stage 2 or unstageable ulcers were more likely than others to have dressings applied to their wounds (p = < 0.001) and to be referred to an occupational therapist for protective devices (p = 0.022).ConclusionParticipants in the intervention group of a clinical trial were more likely to receive additional post trial care and improved documentation compared with those in the control group but documentation of pressure ulcer status and care is poor.     

La educación como pieza clave en la prevención y buena evolución de las úlceras por presión

ObjectiveTo evaluate if an education program for the nursing staff helps to reduce the incidence of pressure ulcers and prevent their poor evolution.Material and methodsA prospective and observational study where the prevention and educational methods have been used to prevent and treat pressure ulcers. All patients has admitted to Intensive Care Unit during one year were included (six months of basal period and six months of post-training period). The following variables were analyzed: incidence of Pressure Ulcers, risk score according to EMINA, ulcer grade and location.ResultsA total of 134 ulcers were identified in the 69 patients (14.37%) with pressure ulcers included in the basal period. Forty-four patients (7.88%) of the patients in the post-training period developed 77 pressure ulcers. The significance level was p < 0.01, OR: 0.40 (95% CI: 0.26-0.62). Fifteen of the 211 pressure ulcers evolved to grade III-IV p > 0.20.ConclusionsConducting a training program in the application of standardized prevention methods for the nursing staff reduces the incidence of pressure ulcers.     

The effect of a patient centred care bundle intervention on pressure ulcer incidence (INTACT): A cluster randomised trial

BackgroundHospital-acquired pressure ulcers are a serious patient safety concern, associated with poor patient outcomes and high healthcare costs. They are also viewed as an indicator of nursing care quality.ObjectiveTo evaluate the effectiveness of a pressure ulcer prevention care bundle in preventing hospital-acquired pressure ulcers among at risk patients.DesignPragmatic cluster randomised trial.SettingEight tertiary referral hospitals with >200 beds each in three Australian states.Participants1600 patients (200/hospital) were recruited. Patients were eligible if they were: ≥18 years old; at risk of pressure ulcer because of limited mobility; expected to stay in hospital ≥48 h and able to read English.MethodsHospitals (clusters) were stratified in two groups by recent pressure ulcer rates and randomised within strata to either a pressure ulcer prevention care bundle or standard care. The care bundle was theoretically and empirically based on patient participation and clinical practice guidelines. It was multi-component, with three messages for patients’ participation in pressure ulcer prevention care: keep moving; look after your skin; and eat a healthy diet. Training aids for patients included a DVD, brochure and poster. Nurses in intervention hospitals were trained in partnering with patients in their pressure ulcer prevention care. The statistician, recruiters, and outcome assessors were blinded to group allocation and interventionists blinded to the study hypotheses, tested at both the cluster and patient level. The primary outcome, incidence of hospital-acquired pressure ulcers, which applied to both the cluster and individual participant level, was measured by daily skin inspection.ResultsFour clusters were randomised to each group and 799 patients per group analysed. The intraclass correlation coefficient was 0.035. After adjusting for clustering and pre-specified covariates (age, pressure ulcer present at baseline, body mass index, reason for admission, residence and number of comorbidities on admission), the hazard ratio for new pressure ulcers developed (pressure ulcer prevention care bundle relative to standard care) was 0.58 (95% CI: 0.25, 1.33; p = 0.198). No adverse events or harms were reported.ConclusionsAlthough the pressure ulcer prevention care bundle was associated with a large reduction in the hazard of ulceration, there was a high degree of uncertainty around this estimate and the difference was not statistically significant. Possible explanations for this non-significant finding include that the pressure ulcer prevention care bundle was effective but the sample size too small to detect this.     

Prevalencia de las úlceras de pierna en la provincia de Cuenca: un estudio en Atención Primaria

ObjectiveTo determine the prevalence of leg ulcers, and to describe the affected patients, wounds, and treatment.MethodObservational, cross-sectional prevalence study. An ad hoc online questionnaire was sent to all nurses attending Primary Care centres of the “Gerencia de Atención Integrada de Cuenca” (Integrated Care Management of Cuenca, Spain). Data regarding patient sociodemographic and clinical variables, lesion characteristics and the type of intervention (concerning prevention and treatment) were collected.ResultsIn total, 152 professionals (response rate = 98.1%) completed the questionnaire, collecting data from 131,190 inhabitants. A total of 63 patients (75.5 ± 12.6 years old) with 75 ulcers were identified, finding an overall prevalence of 0.480‰ (CI 95%: 0.375-0.614), distributed as: venous ulcer 0.274‰ (n = 36), diabetic foot 0.145‰ (n = 19), and arterial ulcer 0.061‰ (n = 8).The prevalence was similar regarding gender (0.535‰ vs. 0.426‰, respectively, p = .365), but men exhibited more diabetic foot (0.214‰ vs. 0.076‰, p = .037).In all three types of lesions prevalence increased with age, reaching 1.743‰ in 64 + age group.The median of the leg ulcer duration and corrected area were 190.0 ± 340.0 days and 5.0 ± 13.7 cm², respectively, with a recurrence rate of 74.7%.ConclusionsThe prevalence of chronic leg ulcers was lower than that reported in other studies, although with high recurrence rates. Overall estimators from previous studies may have overestimated the prevalence, especially in regions with a high rural component.     

The cost-effectiveness of a patient centred pressure ulcer prevention care bundle: Findings from the INTACT cluster randomised trial

BackgroundPressure ulcers are serious, avoidable, costly and common adverse outcomes of healthcare.ObjectivesTo evaluate the cost-effectiveness of a patient-centred pressure ulcer prevention care bundle compared to standard care.DesignCost-effectiveness and cost-benefit analyses of pressure ulcer prevention performed from the health system perspective using data collected alongside a cluster-randomised trial.SettingsEight tertiary hospitals in Australia.ParticipantsAdult patients receiving either a patient-centred pressure ulcer prevention care bundle (n = 799) or standard care (n = 799).MethodsDirect costs related to the intervention and preventative strategies were collected from trial data and supplemented by micro-costing data on patient turning and skin care from a 4-week substudy (n = 317). The time horizon for the economic evaluation matched the trial duration, with the endpoint being diagnosis of a new pressure ulcer, hospital discharge/transfer or 28 days; whichever occurred first. For the cost-effectiveness analysis, the primary outcome was the incremental costs of prevention per additional hospital acquired pressure ulcer case avoided, estimated using a two-stage cluster-adjusted non-parametric bootstrap method. The cost-benefit analysis estimated net monetary benefit, which considered both the costs of prevention and any difference in length of stay. All costs are reported in AU$(2015).ResultsThe care bundle cost AU$144.91 (95%CI: $74.96 to $246.08) more per patient than standard care. The largest contributors to cost were clinical nurse time for repositioning and skin inspection. In the cost-effectiveness analysis, the care bundle was estimated to cost an additional $3296 (95%CI: dominant to $144,525) per pressure ulcer avoided. This estimate is highly uncertain. Length of stay was unexpectedly higher in the care bundle group. In a cost-benefit analysis which considered length of stay, the net monetary benefit for the care bundle was estimated to be −$2320 (95%CI −$3900, −$1175) per patient, suggesting the care bundle was not a cost-effective use of resources.ConclusionsA pressure ulcer prevention care bundle consisting of multicomponent nurse training and patient education may promote best practice nursing care but may not be cost-effective in preventing hospital acquired pressure ulcer.     

Prevalencia de úlceras por presión en atención primaria en dos comarcas catalanas

ObjectiveTo determine the prevalence of and risk factors for skin breakdown due to pressure ulcers.MethodWe performed an observational, cross sectional study between April 1 and April 15, 2003 in all community nurses in the areas of Bages and Berguedà (Barcelona, Spain) and the head nurses of all nursing homes. Information (patient and caregiver characteristics and preventive measures) was gathered on all patients previously diagnosed with skin breakdown or risk of skin breakdown.ResultsA total of 810 patients were studied (209 with skin breakdown and 601 at risk for skin breakdown). The prevalence of patients with skin breakdown due to pressure ulcers was 0.11% among the adult population, 0.42% in individuals aged more than 64 years old, 7.3% in patients receiving home care, and 4.8% in nursing home residents. Each community nurse attended a mean of 3.7 patients (SD = 2.5) at risk of skin breakdown and a mean of 1.8 patients (SD = 1.1) with pressure ulcers.ConclusionsGiven the prevalence of pressure ulcers in patients receiving home care, detection of risk should be increased to prevent ulcer progression. When risk is detected, preventive measures should be increased. Health education should be improved in family caregivers, who play a major role in the process.     

Relación entre el índice de masa corporal y el desarrollo de úlcera por presión en Medicina Intensiva

ObjectivesThis study aims to evaluate the association between body mass index (BMI), incidence and severity of pressure ulcers (PU) in patients admitted to the Intensive Care Unit (ICU), and describe the differential prognosis of patients with PU and factors that modify it.Material and methodsCase-control study with observation period of 15 months. We collected baseline variables, prognostic scales, therapies and clinical outcome. Univariate analysis was performed for each outcome variable between cases and controls using the appropriate hypothesis test depending on the nature of the variables. ROC curve for BMI and PU. Logistic regression with PU as dependent variable and the covariates that reached p < 0.05 in the bivariate analysis. Correlation using Pearson or Spearman was made between BMI, albumin, days to diagnosis of UPP, immobilization, and PU degree. Significance level at p <0.05.Results77 patients developed PU and 231 controls were chosen. The cases had higher APACHE II (p = 0.043) and SAPS 3 (p = 0.023), length of stay in ICU and mechanical ventilation (p < 0.001). BMI ≥ 40 was associated with UPP (p = 0.024 OR = 3.23 CI95% 1.17-8.93). There was a significant association between PU degree, length of stay and MV (p < 0,001), but not with immobilization, dynamic support surface and death rate. Multivariate analysis found association between PU, length of MV (p = 0.013, OR 1.08, CI95% 1.01-1.16) and kidney replacement therapy (p = 0.013, OR 3.55 CI95% 1.31-9.64), with BMI ≥ 40 as a confounding factor.ConclusionsLength of mechanical ventilation and renal replacement therapy are risk factors for pressure ulcer development, and BMI ≥ 40 acts as a confounding factor. PU development and its maximum degree are not associated with a worse prognosis.     

Clinical Parameters Associated With Pressure Ulcer Healing in Patients With Advanced Illness

ContextPressure ulcers are the most prevalent wounds affecting patients with advanced illness. Although complete wound healing is the most desired outcome, it remains unlikely in the setting of patients with limited life expectancy. Realistic goal setting may be enabled using objective clinical parameters.ObjectivesTo identify clinical parameters associated with complete healing of Stage II pressure ulcers.MethodsUnivariable and multivariable competing risk analyses were used to assess the association of complete healing with the following six clinical parameters, namely gender, age, total number of pressure ulcers, total number of other wounds, number of failing organ systems, and Palliative Performance Scale (PPS) scores.ResultsA total of 147 patients with 245 Stage II pressure ulcers were followed until death; 9.4% of Stage II pressure ulcers achieved complete healing. Univariable analyses showed hazard ratios (HRs) for complete healing in favor of higher levels of PPS scores (HR 1.82–5.99, P < 0.001) and age younger than 80 years (HR 3.28, P = 0.031). Multivariable analyses showed HRs for complete healing in favor of higher levels of PPS scores (HR 1.49–3.34, P = 0.003).ConclusionHigher levels of PPS scores are associated with complete healing of Stage II pressure ulcers in patients with advanced illness.     

The role of foot self-care behavior on developing foot ulcers in diabetic patients with peripheral neuropathy: A prospective study

BackgroundAlthough foot self-care behavior is viewed as beneficial for the prevention of diabetic foot ulceration, the effect of foot self-care behavior on the development of diabetic foot ulcer has received little empirical investigation.ObjectiveTo explore the relationship between foot self-care practice and the development of diabetic foot ulcers among diabetic neuropathy patients in northern Taiwan.MethodsA longitudinal study was conducted at one medical center and one teaching hospital in northern Taiwan.ParticipantsA total of 295 diabetic patients who lacked sensitivity to a monofilament were recruited. Five subjects did not provide follow-up data; thus, only the data of 290 subjects were analyzed. The mean age was 67.0 years, and 72.1% had six or fewer years of education.MethodsData were collected by a modified version of the physical assessment portion of the Michigan Neuropathy Screening Instrument and the Diabetes Foot Self-Care Behavior Scale. Cox regression was used to analyze the predictive power of foot self-care behaviors.ResultsA total of 29.3% (n = 85) of diabetic neuropathy patients developed a diabetic foot ulcer by the one-year follow-up. The total score on the Diabetes Foot Self-Care Behavior Scale was significantly associated with the risk of developing foot ulcers (HR = 1.04, 95% CI = 1.01–1.07, p = 0.004). After controlling for the demographic variables and the number of diabetic foot ulcer hospitalizations, however, the effect was non-significant (HR = 1.03, 95% CI = 1.00–1.06, p = 0.061). Among the foot self-care behaviors, lotion-applying behavior was the only variable that significantly predicted the occurrence of diabetic foot ulcer, even after controlling for demographic variables and diabetic foot ulcer predictors (neuropathy severity, number of diabetic foot ulcer hospitalizations, insulin treatment, and peripheral vascular disease; HR = 1.19, 95% CI = 1.04–1.36, p = 0.012).ConclusionsAmong patients with diabetic neuropathy, foot self-care practice may be insufficient to prevent the occurrence of diabetic foot ulcer. Instead, lotion-applying behavior predicted the occurrence of diabetic foot ulcers in diabetic patients with neuropathy. Further studies are needed to explore the mechanism of lotion-applying behavior as it relates to the occurrence of diabetic foot ulcer.     

Gait parameters of people with diabetes-related neuropathic plantar foot ulcers

BackgroundFoot ulceration associated with diabetic peripheral neuropathy is a global concern. Biomechanical investigation allows the identification of gait abnormalities that may adversely affect ulcer healing. The objective of this case–control study was to compare the gait parameters of cases with diabetes-related foot ulcers to controls.MethodsThree-dimensional movement analyses were performed on 21 people with diabetes-related neuropathic plantar foot ulcers (cases), 69 people with diabetes without a foot ulcer history (diabetes controls) and 56 healthy controls. Outcome data were reported as mean differences, 95% confidence intervals and Cohen's d effect sizes. Binary logistic regressions were used to adjust for age, sex and body mass index.FindingsPeople with foot ulcers had a smaller plantar flexion (Cohen's d = − 0.6 vs. diabetes controls and d = − 0.8 vs. healthy controls), knee flexion (d = − 0.6 vs. diabetes controls and d = − 1.0 vs. healthy controls) and pelvic obliquity (d = − 0.9 vs. diabetes controls and d = − 0.7 vs. healthy controls) (all P < 0.05). They also had a significantly greater range of anterior–posterior ground reaction force (d = 1.0 vs. diabetes controls and d = 1.7 vs. healthy controls) and total vertical ground reaction force (d = 0.9 vs. diabetes controls and d = 1.1 vs. healthy controls) and significantly slower walking speed and smaller step length compared to controls (all P < 0.05).InterpretationPeople with plantar foot ulcers have considerably different gait parameters to controls. Whether the observed gait parameters contributed to the ulcer development or are a response to the ulcer is currently unclear and needs further investigation.     

Automated identification of wound information in clinical notes of patients with heart diseases: Developing and validating a natural language processing application

BackgroundElectronic health records are being increasingly used by nurses with up to 80% of the health data recorded as free text. However, only a few studies have developed nursing-relevant tools that help busy clinicians to identify information they need at the point of care.ObjectiveThis study developed and validated one of the first automated natural language processing applications to extract wound information (wound type, pressure ulcer stage, wound size, anatomic location, and wound treatment) from free text clinical notes.Methods and designFirst, two human annotators manually reviewed a purposeful training sample (n = 360) and random test sample (n = 1100) of clinical notes (including 50% discharge summaries and 50% outpatient notes), identified wound cases, and created a gold standard dataset. We then trained and tested our natural language processing system (known as MTERMS) to process the wound information. Finally, we assessed our automated approach by comparing system-generated findings against the gold standard. We also compared the prevalence of wound cases identified from free-text data with coded diagnoses in the structured data.ResultsThe testing dataset included 101 notes (9.2%) with wound information. The overall system performance was good (F-measure is a compiled measure of system’s accuracy = 92.7%), with best results for wound treatment (F-measure = 95.7%) and poorest results for wound size (F-measure = 81.9%). Only 46.5% of wound notes had a structured code for a wound diagnosis.ConclusionsThe natural language processing system achieved good performance on a subset of randomly selected discharge summaries and outpatient notes. In more than half of the wound notes, there were no coded wound diagnoses, which highlight the significance of using natural language processing to enrich clinical decision making. Our future steps will include expansion of the application’s information coverage to other relevant wound factors and validation of the model with external data.     

Prevention of heel pressure ulcers among older patients – from ambulance care to hospital discharge: A multi-centre randomized controlled trial

The aim was to investigate the effect of an early intervention, a heel suspension device boot, on the incidence of heel pressure ulcers among older patients (aged 70 +).BackgroundPressure ulcers are a global healthcare issue; furthermore, the heel is an exposed location. Research indicates that preventive nursing interventions starting during the ambulance care and used across the acute care delivery chain are seldom used.MethodsA multi-centre randomized control study design was used. Five ambulance stations, two emergency departments and 16 wards at two Swedish hospitals participated. Altogether, 183 patients were transferred by ambulance to the emergency department and were thereafter admitted to one of the participating wards.ResultsSignificantly fewer patients in the intervention group (n=15 of 103; 14.6%) than the control group (n=24 of 80; 30%) developed heel pressure ulcers during their hospital stay (p=0.017).ConclusionsPressure ulcer prevention should start early in the acute care delivery chain to increase patient safety.     

Development and evaluation of a nurse-led hypertension management model: A randomized controlled trial

BackgroundThe hypertension prevalence rate is increasing but the control rate is unsatisfactory. Nurse-led healthcare may be an effective way to improve outcomes for hypertensive patients but more evidence is required especially at the community level.ObjectiveThis study aims to establish a nurse-led hypertension management model and to test its effectiveness at the community level.DesignA single-blind, randomized controlled trial was performed in an urban community healthcare center in China. Hypertensive patients with uncontrolled blood pressure (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg) were randomly allocated into two groups: the study group (n = 67) and the control group (n = 67). The nurse-led hypertension management model included four components (delivery system design, decision support, clinical information system and self-management support). Patients in the control group received usual care. Patients in the study group received a 12-week period of hypertension management. The patient outcomes, which involved blood pressure, self-care behaviors, self-efficacy, quality of life and satisfaction, were assessed at three time points: the baseline, immediately after the intervention and 4 weeks after the intervention.ResultsAfter the intervention, the blood pressure of patients in the study group decreased significantly compared to those in the control group, and the mean reduction of systolic/diastolic blood pressure in the study and control groups was 14.37/7.43 mmHg and 5.10/2.69 mmHg, respectively (p < 0.01). In addition, patients in the study group had significantly greater improvement in self-care behaviors than those in the control group (p < 0.01). The study group had a higher level of satisfaction with hypertensive care than the control group (p < 0.01). No statistically significant difference in self-efficacy and quality of life was detected between the two groups after the intervention.ConclusionsThe nurse-led hypertension management model is feasible and effective in improving the outcomes of patients with uncontrolled blood pressure at the community level.     

The effectiveness of lifestyle intervention in early pregnancy to prevent gestational diabetes mellitus in Chinese overweight and obese women: A quasi-experimental study

PurposeGestational diabetes mellitus (GDM) is one of the most common complications of pregnancy and is associated with substantially elevated risk of adverse health outcomes for both mothers and offspring. This quasi-experimental trial was conducted to assess whether a lifestyle intervention in early pregnancy can reduce the incidence of GDM and excessive gestational weight (GWG) gain among Chinese overweight women.MethodsConvenience samples of 74 women in gestational weeks 8–12 with a BMI ≥ 24 kg/m² were enrolled. They were divided into intervention (N = 37) or control group (N = 37) according to the time sequence of seeing the doctor. The intervention group was provided with exercise, dietary, weight gain counseling and detailed plans at weeks 8–12 and every month in the second trimester. In addition, each counseling session included a personalized feedback based on their 5-day-records. Follow-up phone calls or emails were conducted every week between antenatal visits. The control group was just provided with exercise, dietary and weight gain counseling at weeks 8–12, besides the usual health education provided at the O&G outpatient department.ResultsThe lifestyle intervention resulted in a lower incidence of gestational diabetes in the intervention group (9/32, 28.1%) compared with the control group (19/34, 55.9%), p = 0.023. Women in the intervention group gained much less weight (6.86 ± 2.31 versus 10.08 ± 3.84 kg, p = 0.000) at the end of second trimester.ConclusionLifestyle intervention in early pregnancy can reduce the incidence of GDM and prevent excessive maternal weight gain in overweight and obese pregnant women.     

An evaluation of involving family caregivers in the self-care of heart failure patients on hospital readmission: Randomised controlled trial (the FAMILY study)

BackgroundThe prevalence of heart failure is increasing in Lebanon but to date there is no systematic evaluation of a disease management intervention.ObjectiveThe aim of this study was to evaluate the effect of involving family caregivers in the self-care of patients with heart failure on the risk of hospital readmission.DesignA multi-site, block randomised controlled trial.SettingsThe study was conducted over a 13-month period in three tertiary medical centres in Beirut and Mount Lebanon, Lebanon.ParticipantsAdult patients presenting for an exacerbation of heart failure to one of the study centres were included. Patients with limited life expectancy or physical functionality, planned cardiac bypass or valve replacement surgery, living alone or in nursing homes, or aged less than 18 years were excluded.MethodsPatients allocated to the intervention group and their family caregivers were provided with a comprehensive, culturally appropriate, educational session on self-care maintenance and symptom management along with self-care resources. The usual care group received the self-care resources only. Follow-up phone calls were conducted 30 days following discharge by a research assistant blinded to treatment assignment. The primary outcome was hospital readmission and the secondary outcomes were self-care, quality of life, major vascular events and healthcare utilization.ResultsThe final sample included 256 patients hospitalized for heart failure randomised into control (130 patients) and intervention (126 patients) groups. The mean age was 67 (SD = 8) years, and the majority (55%) were male. Readmission at 30 days was significantly lower in the intervention group compared to the control group (n = 10, 9% vs. n = 20, 19% respectively, OR = 0.40, 95% CI = 0.02, 0.10, p = 0.02). Self-care scores improved in both groups at 30 days, with a significantly larger improvement in the intervention group than the control group in the maintenance and confidence sub-scales, but not in the self-care management sub-scale. No differences were seen in quality of life scores or emergency department presentations between the groups. More patients in the control group than in the intervention group visited health care facilities (n = 24, 23% vs. n = 12, 11% respectively, OR = 0.39, 95% CI = 0.18, 0.83, p = 0.01).ConclusionThe trial results confirmed the potential of the family-centred self-care educational intervention under evaluation to reduce the risk of readmission in Lebanese patients suffering from exacerbated heart failure. Further research is needed to validate these findings with longer periods of follow-up and to identify the intervention components and intensity required to induce sustained benefits on patients' self-care management and quality of life.     

Uso profiláctico de apósitos de silicona para minimizar las lesiones por presión: revisión sistemática y metaanálisis

ObjectivePreventing hospital-acquired pressure injuries (PI) in critically ill patients remains a significant clinical challenge because of its associated high risk for comorbid conditions. We assessed the preventive effectiveness of silicone dressings among patients admitted in intensive care units and non-intensive care units settings.MethodsA literature search was conducted across 3 electronic databases (MEDLINE, EMBASE, Cochrane Central) from inception through December 2021. Studies assessing the effectiveness of silicone dressing on the incidence of PI on the sacral area were included. evaluations were reported as risk ratios (RRs) with 95% confidence interval, and analysis was performed using a random-effects model.ResultsOf the 1,056 articles retrieved from the initial search, 11 studies were included in the final analysis. Silicone dressings significantly reduced the incidence of PI compared to usual care (RR: 0.30, 95%CI: 0.19-0.45, P < 0.01). We found no significant difference between results of studies conducted in intensive care settings (RR = 0.25, 95%CI: 0.15-0.43, P < 0.01) and non-intensive care settings (RR = 0.38, 95%CI: 0.17-0.83, P = 0.01) (P-interaction: 0.39). Silicone dressings reduced the risk of developing PI among patients using five-layer foam Border dressing (Mepilex® Sacrum) (RR: 0.31, 95%CI: 0.20-0.48, P < 0.01), and dressing Allevyn Gentle Border® (RR: 0.10, 95%CI: 0.01-0.73, P = 0.02) with no significant difference upon subgroup analysis (P-interaction: 0.27).ConclusionThe present meta-analysis suggests that silicone dressings consistently reduce the incidence of PI in intensive as well as in non-intensive care settings, regardless of the type of dressing used.     

Lower-extremity dynamics of walking in neuropathic diabetic patients who wear a forefoot-offloading shoe

BackgroundA forefoot-offloading shoes has a negative-heel rocker outsole and is used to treat diabetic plantar forefoot ulcers, but its mechanisms of action and their association with offloading and gait stability are not sufficiently clear.MethodsTen neuropathic diabetic patients were tested in a forefoot-offloading shoe and subsequently in a control shoe with no specific offloading construction, both worn on the right foot (control shoe on left), while walking at 1.2 m/s. 3D-instrumented gait analysis and simultaneous in-shoe plantar pressure measurements were used to explain the shoe's offloading efficacy and to define centre-of-pressure profiles and left-to-right symmetry in ankle joint dynamics (0–1, 1:maximum symmetry), as indicators for gait stability.FindingsCompared to the control shoe, peak forefoot pressures, vertical ground reaction force, plantar flexion angle, and ankle joint moment, all in terminal stance, and the proximal-to-distal centre-of-pressure trajectory were significantly reduced in the forefoot-offloading shoe (P < 0.01). Peak ankle joint power was 51% lower in the forefoot-offloading shoe compared to the control shoe: 1.61 (0.35) versus 3.30 (0.84) W/kg (mean (SD), P < 0.001), and was significantly associated with forefoot peak pressure (R² = 0.72, P < 0.001). Left-to-right symmetry in the forefoot-offloading shoe was 0.39 for peak ankle joint power.InterpretationBy virtue to their negative-heel rocker-outsole design, forefoot-offloading shoes significantly alter a neuropathic diabetic patient's gait towards a reduced push-off power that explains the shoe's offloading efficacy. However, gait symmetry and stability are compromised, and may be factors in the low perceived walking discomfort and limited use of these shoes in clinical practice. Shoe modifications (e.g. less negative heel, a more cushioning insole) may resolve this trade-off between efficacy and usability.     

The functioning of social support in long-term prevention after spinal cord injury. A qualitative study

BackgroundThe impact of social support on the long-term condition after a spinal cord injury (SCI) varies across studies mainly involving self-report questionnaires.ObjectiveWe aimed to establish the common factors associated with social support leading individuals with an SCI to the effective prevention of secondary complications, including via adherence to medical follow-up.MethodsInclusion criteria were a history of acquired SCI of any etiology, wheelchair use, and age ≥ 18 years at the time of the study. Participants should have completed their initial rehabilitation program in France ≥ 1 year earlier and were also enrolled according to 2 related study variables: routine medical follow-up (patients were or were not followed up) and the medically supervised reporting of a pressure ulcer after the initial rehabilitation session (0 or ≥ 1 pressure ulcers). We performed a preparatory quantitative and qualitative literature review to identify factors affecting long-term follow-up after SCI, then adopted a narrative design with semi-structured interviews, transcribed and analyzed progressively by using qualitative analysis software.ResultsWe included 32 participants. We categorized our results based on the knowledge, attitudes, beliefs and practices of participants with respect to pressure ulcer prevention and long-term medical follow-up. Our narrative approach allowed us to identify 3 main domains relevant to social support: reciprocity, self-management and timing related to social support.ConclusionsOur study showed social support as a dynamic process, a reciprocal phenomenon evolving in variations over time. These findings should be central to short- and long-term therapeutic education programs for patients and for people providing social support. Effective changes should also be implemented through the concept of the Learning Health System.     

Effectiveness of certified diabetes educators following pre-approved protocols to redesign diabetes care delivery in primary care: Results of the REMEDIES 4D trial

ObjectiveTo evaluate changes in HbA1c, blood pressure, and LDLc levels in participants from practices where certified diabetes educators (CDEs) implemented standardized protocols to intensify treatment compared with those receiving usual care.Research design and methodsThis clustered, randomized, clinical trial was implemented in community-based primary care practices. Fifteen primary care practices and 240 patients with type 2 diabetes were randomized to the intervention (n = 175) or usual care (n = 65). Participants had uncontrolled HbA1c, blood pressure, or LDLc. The one-year intervention included CDEs implementing pre-approved protocols to intensify treatment. Diabetes self-management education was also provided in both study groups.ResultsThe population was 50.8% male with a mean age of 61 years. The HbA1c in the intervention group decreased from 8.8% to 7.8%, (p = 0.001) while the HbA1c in the usual care group increased slightly from 8.2% to 8.3%. There was also a significant difference in HbA1c between the two groups (p = 0.004). There was not a significant difference between groups for systolic blood pressure (SBP) or LDLc at the end of the intervention. Those in the intervention group were more likely to have glucose-lowering medications intensified and were more likely to have their HbA1c (35% vs 15%), SBP (80% vs 77%) and HbA1c, SBP, and LDLc at goal (11% vs 1.5%) compared with the usual care group. There was no significant difference in intensification of blood pressure or cholesterol medication.ConclusionsFindings suggest that CDEs following standardized protocols in primary care is feasible and can effectively intensify treatment and improve glycemic control.