Risk factors for plantar foot ulcer recurrence in neuropathic diabetic patients.

OBJECTIVE: Recurrence of plantar foot ulcers is a common and major problem in diabetes but not well understood. Foot biomechanics and patient behavior may be important. The aim was to identify risk factors for ulcer recurrence and to establish targets for ulcer prevention. RESEARCH DESIGN AND METHODS: As part of a footwear trial, 171 neuropathic diabetic patients with a recently healed plantar foot ulcer and custom-made footwear were followed for 18 months or until ulceration. Demographic data, disease-related parameters, presence of minor lesions, barefoot and in-shoe plantar peak pressures, footwear adherence, and daily stride count were entered in a multivariate multilevel logistic regression model of plantar foot ulcer recurrence. RESULTS: A total of 71 patients had a recurrent ulcer. Significant independent predictors were presence of minor lesions (odds ratio 9.06 [95% CI 2.98-27.57]), day-to-day variation in stride count (0.93 [0.89-0.99]), and cumulative duration of past foot ulcers (1.03 [1.00-1.06]). Significant independent predictors for those 41 recurrences suggested to be the result of unrecognized repetitive trauma were presence of minor lesions (10.95 [5.01-23.96]), in-shoe peak pressure <200 kPa with footwear adherence >80% (0.43 [0.20-0.94]), barefoot peak pressure (1.11 [1.00-1.22]), and day-to-day variation in stride count (0.91 [0.86-0.96]). CONCLUSIONS: The presence of a minor lesion was clearly the strongest predictor, while recommended use of adequately offloading footwear was a strong protector against ulcer recurrence from unrecognized repetitive trauma. These outcomes define clear targets for diabetic foot screening and ulcer prevention.

Perceived usability and use of custom-made footwear in diabetic patients at high risk for foot ulceration.

OBJECTIVE: To assess the perceived usability and use of custom- made footwear in diabetic patients who are at high-risk for foot ulceration, and to elucidate the determinants of usability and use. DESIGN: Survey. SUBJECTS: A total of 153 patients with diabetes, peripheral neuropathy, prior plantar foot ulceration and newly prescribed custom-made footwear, recruited from 10 Dutch multidisciplinary foot clinics. METHODS: The Questionnaire of Usability Evaluation was used to assess the patients' perception of weight, appearance, comfort, durability, donning/doffing, stability, benefit and overall appreciation of their prescription footwear (all expressed as visual analogue scores). Data on priorities for usability and footwear use (in h/day) were obtained from patient reports. Multivariate logistic regression analysis was used to assess determinants of usability and use. RESULTS: Median (interquartile range) score for overall appreciation was 8.3 (7.1-9.1). Scores ranged from 6.5 (4.5-8.6) for weight to 9.6 (6.3-9.9) for donning/doffing. Footwear comfort was listed most often (33.3%) as the highest priority. Footwear use was <60% of daytime (where daytime was defined as 16 h out of bed) in 58% of patients. The only significant determinant of footwear use was the perceived benefit of the footwear (p = 0.045). CONCLUSION: Perceived usability of footwear was mostly positive, although individual scores and priorities varied considerably. Footwear use was low to moderate and dependent only on the perceived benefit of the footwear. Therefore, practitioners should focus on enhancing the patient's ap-preciation of the therapeutic benefit of custom-made footwear.

High satisfaction with an individualised stroke care programme after hospitalisation of patients with a TIA or minor stroke: a pilot study.

BACKGROUND: Many hospitalised patients with a transient ischaemic attack (TIA) or minor stroke develop subtle cognitive disorders and emotional problems a few weeks after discharge, and are dissatisfied with the care they have received, even with specialised stroke care programmes. Therefore, an individualised stroke care programme was developed to match the therapy with the personal care needs. In this pilot study we evaluated the feasibility of the rehabilitation programme, the satisfaction of stroke patients with this programme, and the factors associated with satisfaction. METHODS: Consecutive patients who were hospitalised with a TIA or minor stroke, with no apparent residual deficits, were eligible. Occupational and neuropsychological screening was applied 4-6 weeks after discharge, and therapy was provided when necessary. After 6 months, satisfaction with care (Satisfaction-With-Stroke-Care-19), was assessed as the primary outcome. Secondary outcomes were quality of life (QoL), disability, handicap, anxiety and depression. RESULTS: 42 patients with a TIA or minor stroke participated in the programme and the follow-up. Of all the participants, 71% were satisfied with the care they have received after discharge. Male patients were more satisfied than female patients. Dissatisfied patients were less able to perform the activities of daily living, had a lower QoL and more depressive symptoms. After regression analysis, only the Barthel Index was independently associated with satisfaction. CONCLUSIONS: In this pilot study, our individualised stroke care programme seems to have improved patient satisfaction. Ability to perform daily activities is associated with satisfaction. A randomised controlled trial is needed to confirm the effectiveness of this rehabilitation programme.

Making better drugs: Decision gates in non-clinical drug development.

Drug development is a risky business. Success or failure often depends on selecting one or two molecules for development from many choices offered by the engines of high-throughput discovery. A lead candidate needs to possess adequate bioactivity, appropriate physical-chemical properties to enable formulation development, the ability to cross crucial membranes, reasonable metabolic stability and appropriate safety and efficacy in humans. Predicting how a drug will behave in humans before clinical testing requires a battery of sophisticated in vitro tests that complement traditional in vivo animal safety assessments. This review discusses how to strategically identify which non-clinical studies should be performed to provide the required guidance and comfort to stakeholders involved in clinical drug testing.

Safety of direct laryngoscopy as an outpatient procedure.

The safety of outpatient direct laryngoscopy has recently been challenged in the literature. We reviewed the first 589 direct laryngoscopies performed at a new outpatient surgery center. There were nine unplanned admissions to the hospital, including five airway emergencies that developed within the first 30 min after extubation. Three patients required reintubation before leaving the operating room. On postoperative telephone follow-up, 9% complained of mild to moderate sore throat. There were no major complications after discharge. We conclude that the risk of airway emergencies after direct laryngoscopy is less than 1% in carefully selected patients. The procedure can be safely performed as an outpatient procedure as long as transportation to a hospital is readily available for the few patients in whom complications arise.

The difficult airway: mechanisms for effective dissemination of critical information.

The perioperative management and dissemination of critical information regarding a patient with an unexpected difficult intubation, including successful application of a difficult airway algorithm (Figure 1), are described. Documentation and dissemination of critical information include entry of patient data into an in-hospital computerized Difficult Airway/Intubation Registry, simultaneous application of a highly visible Difficult Airway/Intubation Patient Wrist Band (coded for access to computer registry), summary reports distributed to health care providers, and enrollment of the patient in the Medic Alert Foundation International's newly established category difficult airway/intubation for 24-hour access. We postulate that the widespread use of the procedures described in this report may reduce the contribution of unexpected difficult airway/intubation to anesthetic morbidity and mortality.

Heparin management protocol for cardiopulmonary bypass influences postoperative heparin rebound but not bleeding.

A group of 63 adult patients undergoing cardiac surgical procedures requiring cardiopulmonary bypass (CPB) were studied to examine the relationship between heparin doses administered and postoperative bleeding. Patients were randomly assigned either to receive heparin 200 U/kg and additional heparin as needed to reach and maintain an activated clotting time (ACT) greater than 400 s for CPB (group A, n = 30), or to receive heparin 400 U/kg and additional heparin as needed to reach and maintain a whole blood heparin concentration greater than 4.0 U/ml for CPB (group H, n = 33). Groups were compared for the amount of postoperative bleeding, heparin rebound, homologous transfusion requirements, and standard laboratory coagulation tests. In the last 33 patients studied, additional tests of platelet aggregation and plasma levels of beta thromboglobulin (BTG), antithrombin III, and several markers of fibrinolysis were measured and compared by group. The mean heparin dose was 28,000 +/- 4,800 U for group A and 57,000 +/- 10,700 U for group H (P less than 0.05 for group A vs. group H). At 8 and 24 h postoperatively, mediastinal drainage did not differ significantly between groups (mean 24-h drainage +/- SD = 901 +/- 414 ml in group A, 1035 +/- 501 ml in group H), nor did the incidence of transfusion with homologous blood products.(ABSTRACT TRUNCATED AT 250 WORDS)

Baseline activated coagulation time should be measured after surgical incision.

The activated coagulation time (ACT) is widely used to guide heparin and protamine dosing during cardiac surgery. A common protocol involves establishing a baseline ACT before administering heparin, then using this ACT as a target value for assessing the adequacy of heparin neutralization after cardiopulmonary bypass. Results vary in previous comparisons of baseline ACT to postprotamine ACT, with some showing postprotamine ACT significantly below baseline values. The present study examined ACTs at three possible baseline intervals in 68 patients at two institutions: (a) before anesthetic induction; (b) after anesthetic induction; and (c) after sternotomy. Baseline ACT decreased significantly with anesthesia and surgery. The poststernotomy baseline ACT best matched the postprotamine ACT. It appears likely that surgery induces a thromboplastic response that decreases ACT. Establishing baseline ACT before anesthetic induction would predispose to false diagnoses of adequate protamine neutralization after cardiopulmonary bypass, because ACT is relatively insensitive to low concentrations of unneutralized heparin. Baseline ACTs should therefore be measured after surgical incision.

Calcium does not augment phenylephrine's hypertensive effects.

Ca and phenylephrine, both of which increase mean arterial pressure (MAP), are often administered concurrently during resuscitation of critically ill patients. To determine whether the response to phenylephrine is potentiated by Ca administration, we studied eight adult patients 24 h after aortocoronary bypass surgery. Each patient received three doses of phenylephrine (150, 300, and 450 ng/kg.min), administered both with and without CaCl2 (5 mg/kg bolus followed by a 2-mg/kg.h infusion). Phenylephrine alone at 150, 300, and 450 ng/kg.min increased MAP by 2%, 6%, and 17%, respectively. Ca alone increased serum ionized Ca levels from 1.00 +/- .03 (SEM) to 1.20 +/- .02 mM (p less than .05) and increased MAP from 84 +/- 1 to 90 +/- 2 mm Hg (p less than .05), but had no effect on cardiac index (CI). When administered concurrently with Ca, phenylephrine at 150, 300, and 450 ng/kg.min increased MAP by 6%, 7%, and 13%, respectively. Phenylephrine had no effect on CI, pulmonary capillary wedge pressure, CVP, or heart rate whether or not it was administered with Ca. We conclude that concomitant Ca administration does not augment the hypertensive response to phenylephrine in normotensive patients recovering from open heart surgery.

Calcium attenuates epinephrine's beta-adrenergic effects in postoperative heart surgery patients.

Epinephrine and calcium possess both cardiac inotropic and vasopressor activity. In addition, epinephrine's cardiovascular effects are mediated via increases in intracellular calcium. As a result, many clinicians administer the two agents together in an attempt to augment their effects. Although this approach seems rational, it has never been proven effective. We evaluated the cardiovascular and hyperglycemic actions of epinephrine (10 and 30 ng/kg/min), with and without calcium chloride administration (10 mg/kg bolus followed by 2 mg/kg/hr infusion), in a prospective, randomized, blinded, crossover designed study. Twelve adult patients were studied 1 day after aortocoronary bypass surgery. Calcium chloride raised ionized calcium levels from 1.06 +/- 0.03 (mean +/- SEM) to 1.44 +/- 0.05 mM (p less than 0.05). Calcium raised mean arterial pressure from 85 +/- 1 to 94 +/- 2 mm Hg (p less than 0.05) but had no significant effect on cardiac index. Epinephrine alone at 10 and 30 ng/kg/min significantly raised cardiac index from 2.7 +/- 0.2 to 3.0 +/- 0.2 (p less than 0.05) and 3.6 +/- 0.3 (p less than 0.05) l/min/m2. After calcium, epinephrine failed to significantly increase cardiac index. Epinephrine at 30 ng/kg/min significantly increased mean arterial pressure from 87 +/- 1 to 95 +/- 2 mm Hg (p less than 0.05). After calcium, epinephrine had no significant effect on blood pressure. In addition, epinephrine's hyperglycemic effect was blunted by calcium. Plasma epinephrine levels were similar during control and calcium infusions. We conclude that calcium blunts epinephrine's beta-adrenergic actions in postoperative cardiac surgery patients.