Fadel Derry

A two-part pilot study of sildenafil (VIAGRA) in men with erectile dysfunction caused by spinal cord injury.

Study design: This was a two-part pilot study in men with erectile dysfunction (ED) due to spinal cord injury (SCI: cord level range T6-L5). Part I was a randomised, double-blind, two-way cross-over study comparing a single dose of sildenafil 50 mg or placebo. Part II was a randomised, double-blind, parallel-group evaluation of sildenafil 50 mg or placebo, taken as required (not more than once daily) approximately 1 h prior to sexual activity, over a period of 28 days. Objectives: To assay the efficacy and safety of sildenafil 50 mg and placebo. Setting: Clinic- and home-based assessments in the United Kingdom. Methods: A total of 27 subjects who were able to achieve at least a grade 2 erection (hard, but not hard enough for penetration) in response to penile vibratory stimulation (PVS) were recruited. In Part I, the reflexogenic response of the penis to PVS was evaluated in the clinic while in Part II, the response to treatment was assessed in the home (global efficacy, questionniare, diary). Results: In Part I, 17/26 (65%) subjects had erections of >60% rigidity at the penile base (median duration 3.5 min) after sildenafil compared with 2/26 (8%) (median duration 0 min) after placebo (P=0.0003). In Part II, 9/12 (75%) subjects on sildenafil and 1/14 (7%) subjects on placebo reported that the treatment had improved their erections (P<0.005), and 8/12 (67%) and 2/13 (15%) men, respectively, indicated that they wished to continue treatment (P<0.02). An analysis of diary data showed no difference between the groups with respect to the mean number of erections hard enough for penetration (P=0.08). The mean proportion of attempts at sexual intercourse that were successful was 30 and 15%, respectively (P=0.21). Similarly, responses to the end-of-treatment questionnaire indicated that there were no significant differences between the groups with respect to the frequency of erections hard enough for sexual intercourse (P=0.47) or that lasted as long as the subject would have liked (P=0.11). No subject discontinued sildenafil due to adverse events. Conclusion: Sildenafil is an effective, well-tolerated oral treatment for ED in SCI subjects. Sponsorship: This study was funded by Pfizer Inc.

Efficacy and safety of sildenafil citrate (Viagra) in men with erectile dysfunction and spinal cord injury: a review.

Spinal cord injury (SCI) affects a substantial number of men who are young, active, and otherwise healthy. Erectile dysfunction (ED) is a common consequence of SCI. Since its approval, sildenafil citrate (Viagra) has been shown to effectively treat ED of various etiologies. We review the evidence for the efficacy and safety of sildenafil treatment of ED in men with SCI. A literature search identified 2 randomized controlled trials and 4 prospective case series that evaluated sildenafil treatment for ED from SCI. Efficacy was evaluated using an assessment of global efficacy and a more specific assessment of erectile function. For general efficacy, the proportion of patients who reported improved erections and ability to have intercourse was as high as 94%. Up to 72% of intercourse attempts were successful. For measures of erectile function, 5 of the 6 studies showed statistically significant improvements among sildenafil-treated versus placebo-treated patients. Erectile response rates were generally higher in patients with incomplete versus complete SCI and in patients with upper versus lower motor neuron lesions. Nevertheless, a substantial proportion of patients with complete lesions, regardless of level or lower motor neuron lesions, also benefited from sildenafil. Sildenafil was well tolerated. Incidence rates and types of adverse events that occurred in these studies were similar to those published previously. Symptoms of autonomic dysreflexia were not reported in any study. Existing evidence suggests that oral sildenafil is a highly effective and well-tolerated treatment for ED associated with SCI.

Validation of the spinal nutrition screening tool (SNST) in patients with spinal cord injuries (SCI):result from a multicentre study

Background/Objectives:A disease-specific nutrition screening tool (NST): the spinal nutrition screening tool (SNST) has been developed for use in patients with spinal cord injury (SCI) but its reliability and agreement with other published tools requires investigation. The aims of this study were to assess the prevalence of malnutrition risk in SCI patients and to confirm the diagnostic accuracy of the SNST.Subjects/Methods:Patients’ baseline clinical data, anthropometric measurements and NST scores were assessed. The validity of the SNST was assessed by (i) comparing with a full dietetic assessment (criterion validity); (ii) comparison with a generic NST: malnutrition universal screening tool (MUST) (concurrent validity); and (iii) completion of an additional SNST to assess inter- and intra-rater reliability. Agreement was assessed using Cohens κ-statistics.Results:Using the SNST, the prevalence of malnutrition risk ranged from 22 to 64% on admission to four SCI centres. The SNST had substantial agreement with MUST (κ: 0.723, 95% confidence interval (CI): 0.607–0.839) and dietitian assessment (κ: 0.567, 95% CI: 0.434–0.699). The SNST had a moderate to substantial reliability (inter-rater reliability: κ: 0.5, 95% CI: 0.2–0.8; intra-rater reliability: κ: 0.64, 95% CI: 0.486–0.802). When compared with dietetic assessment, the SNST had a numerically lower specificity (76.1% vs 80.4%) and similar agreement to MUST (κ: 0.57 vs 0.58) but SNST showed a numerically higher sensitivity (85.7% vs 80.4%) and a numerically higher negative predictive value (92% vs 89.2%) than MUST.Conclusions:This study shows that malnutrition is common in SCI patients. The SNST is an acceptable (valid and reliable) NST and may be a useful alternative to MUST in identifying SCI patients at risk of malnutrition.

Is undernutrition risk associated with an adverse clinical outcome in spinal cord-injured patients admitted to a spinal centre?

Background/objectives:To evaluate whether undernutrition risk measured using the Spinal Nutrition Screening Tool (SNST) and the Malnutrition Universal Screening Tool (MUST) is associated with worse clinical outcomes in respect of length of in-patient hospital stay (LOS) and mortality in the 12 months after admission to a spinal cord injuries (SCIs) centre.Methods:A multicentre, prospective, cross-sectional observational study was conducted in four UK SCI centres (SCICs). A total of 150 SCI patients (aged 18–88 years (median: 44 years), 30.7% females) were studied between July 2009 and March 2010. LOS and mortality 12 months after admission to the SCIC was monitored. Multivariate regression analysis was used to identify unique predictors of the variance of LOS.Results:The patients initially undernourished or at risk of undernutrition (44.6%) had a significantly longer LOS (median (days): 129 vs 85, P=0.012) and greater 12-month mortality (% deceased: 9.2% vs 1.4%, P=0.036). In addition, serum albumin and new admission to an SCIC were identified as independent predictors for long LOS.Conclusion:The present study suggests that undernutrition risk, as identified by the SNST, is associated with adverse clinical outcomes. Nutritional screening should be helpful in improving clinical outcomes if it promotes more appropriate and effective nutritional intervention.

How do spinal cord injury centres manage malnutrition? A cross-sectional survey of 12 regional centres in the United Kingdom and Ireland

Study design:A multi-centre, cross-sectional survey.Objectives:To establish and compare the resources allocated against existing national standards, and to document current nutritional screening practices.Setting:Spinal cord injury centres (SCICs) in the United Kingdom and the Republic of Ireland.Methods:After obtaining research ethics committee approval, 12 SCICs in the United Kingdom and the Republic of Ireland were surveyed by a postal questionnaire. Data collected included the number of whole time equivalent (WTE) staff available, whether a nutrition team was present and the use of nutritional screening tools in the SCIC.Results:Eleven (92%) SCICs responded. In total there were 482 allocated beds, and the average numbers of patients per WTE staff (s.d.), including consultants, nurses, dietitians, physiotherapists, occupational therapists and psychologists, were recorded. Eight centres used a nutritional screening tool, and only two centres had a clinical nutrition team.Conclusion:The resources allocated to nutritional care in SCICs appear to be very limited. This suggests that malnutrition will continue to be under-recognised and under-treated. There is a clear need for additional resources to address the nutritional needs of this special population group. Each SCIC should ensure regular access to nutritional advice, and the establishment of local nutrition support teams should be a priority.

An audit to assess awareness and knowledge of nutrition in a UK spinal cord injuries centre

Study design:A single centre survey.Objectives:To test: (i) awareness of nutrition screening tools and related care plans and; (ii) nutrition knowledge of doctors, nurses and dietitians working in spinal cord injuries (SCI) centres.Methods:The 14-item questionnaire was sent to 102 nurses, 17 doctors and 15 dietitians working in UK SCI centres during January–March 2010.Results:Sixty-two (46.5%) questionnaires were completed and returned for analysis. The present audit demonstrated that awareness of the need for nutritional screening is good: 83% of staff reported that they are aware there is a nutrition screening tool. This audit also demonstrated areas of poor knowledge, such as calorie content of intravenous fluids, indicators of malnutrition, and choice of nutritional support in malnourished patients. All doctors, but only 38% of nurses, knew how to calculate body mass index. Surprisingly, nearly half (49%) of the participants thought that at least 20% weight loss was required to indicate malnutrition. This high-perceived cut-off point suggests that malnutrition is likely to continue to be undetected and unmanaged. The overall scores (median) showed clear differences in nutritional knowledge between groups (median: dietitians 92.8%; doctors 53.5%; nurses 35.7; P<0.01). This suggests that dietitians could have an important role in training healthcare professionals about nutrition.Conclusion:This study highlights the need for further education in SCI medicine in order to improve the efficacy of feeding and nutrition therapy for SCI patients.

An audit to assess knowledge about malnutrition among staff working in the UK SCI centres

The importance of screening, identifying, treating and monitoring has been widely described in many international and national guidance. Recent UK-based multicentre study has identified that one in three patients with spinal cord injuries are at risk of malnutrition when admitted to the SCI centre (1) . Yet only 20 % of these at-risk patients were referred for dietetic assessment and further intervention. Part of this is due to ignorance of the subject and its importance amongst, surgical trainees, for example (2) . We therefore decided to test the knowledge of malnutrition amongst doctors, nurses and dietitians in the SCI centre to see if it was a cause of the problem of underdiagnosis. The questionnaire aimed to test: (1) Awareness of nutrition screening tools and related care plans and; (2) Knowledge of doctors, nurses and dietitians working in the SCI centre. One hundred and fifteen questionnaires were sent to 102 nurses, 17 doctors and 15 dietitians working in the UK SCI centres during January to March 2010. The questionnaires contain 14 multiple choice questions, with one in five possible answers considered correct, and there is an open question for ideas on improving nutrition screening in the SCI centre. 62 (46.3%) questionnaires were completed and returned for analysis. This includes 10 doctors, 39 nurses and 9 dietitians. The present audit demonstrated that awareness of the need for nutritional screening is good: 83 % of staff reported they are aware there is a nutrition screening tool. This audit also demonstrated areas of poor knowledge such as calorie content of intravenous fluids, indicators of malnutrition and choice of nutritional support in malnourished patients. Although all doctors knew how to calculate BMI, only 38 % of nurses know how to calculate BMI. Surprisingly, nearly half (49 %) of the participants thought that 20 % weight loss or more was required to indicate malnutrition. This high perceived cut-off point, suggests that malnutrition is likely to continue to be undetected and unmanaged. The overall scores (median) showed clear differences in nutritional knowledge between groups (median; dietitians 92.8%, doctors 53.5%, nurses 35.7 %, P < 0.01 or less. This suggests that dietitians have an important role in training health and social care professionals in nutrition. This study highlights the need for further education in SCI medicine in order to improve the efficacy of feeding and nutrition therapy for SCI patients.

A three-stage evaluation of the Spinal Nutrition Screening Tool (SNST) in patients with Spinal Cord Injuries (SCI) – results from a UK multicentre validation study

Malnutrition is both a cause and consequence of illness, particularly in vulnerable patients who have a spinal cord injury (SCI). Data on the prevalence of malnutrition in the SCI population are lacking and SCI centres (SCIC) reported different practiced in screening malnutrition. A disease specific nutrition screening tool (NST): the Spinal Nutrition Screening Tool (SNST) based on eight parameters (body mass index (BMI); age; level of SCI; presence of co-morbidities; skin conditions; diet; appetite and ability to eat) has been developed for use in SCIC but its reliability and agreement with other published tools requires investigation. The aims of the present study were to assess the prevalence of malnutrition risk and the diagnostic accuracy of the SNST. After obtaining ethics approval, baseline clinical data, anthropometric measurements, NST scores, and blood biochemistry were assessed in 4 UK SCIC between July 2009–March 2010. The validity of SNST was tested by (i) comparison with full dietetic assessment (criterion validity); (ii) comparison with a generic NST: Malnutrition Universal Screening Tool (MUST) (concurrent validity); and (iii) an additional SNST form which was completed by the research dietitian to assess interand intra-rater reliability. Agreement was tested using Cohen’s k-statistics. One hundred and fifty patients (aged 18–88, median: 44, 30.7% female) were studied on admission. Using SNST, the prevalence of undernutrition risk was 44.6% (range 27.3–64.2%) and 45% were overweight (BMI>25 kg/m). SNST had “substantial agreement” with MUST (k: 0.723, 95% CI: 0.607–0.839) and with dietitian assessment (k: 0.567, 95% CI: 0.434–0.699). The SNST had moderate to substantial reliability (Interrater reliability: k: 0.5, 95% CI: 0.2–0.8; Intra-rater reliability: k: 0.64, 95% CI: 0.486–0.802). When dietetic assessment was used as a reference, SNST had similar specificity, sensitivity, and negative predictive value to MUST (76.1% v 80.4%; 85.7% v 80.4%; and 92.0% v 89.2%, respectively.) Patients at risk of undernutrition were found to have significantly reduced total protein, albumin, magnesium, creatinine, haemoglobin, BMI, appetite and significantly higher C-reactive protein; they also received more prescribed medications. The present study shows that malnutrition is common in patients with SCI. SNST is acceptable (valid and reliable), and may be a useful alternative to MUST in identifying SCI patients at risk of malnutrition. Further investigation is warranted to test its predictive validity.

How malnutrition is detected and managed in patients with spinal cord injuries (SCI): results from a UK multi-centre study

Malnutrition has severe adverse effects on health outcomes and healthcare expenditure. However, recognition and treatment of malnutrition (under/overnutrition) in patients with spinal cord injuries (SCI) in SCI centres (SCIC) are not often a priority in clinical practice and data on the prevalence of malnutrition in SCI patients are limited. The aims of the study were to (1) investigate how nutritional risk of patients is determined across all twelve SCIC in the UK and Ireland; (2) establish the prevalence of malnutrition using a generic nutrition screening tool (NST), Malnutrition Universal Screening Tool (MUST) and BMI. After obtaining ethics approval, 11/12 SCIC participated in part 1 of the study. Eight used NSTs, three had no dedicated staff member for nutritional care, and nine SCIC reported that they did not have a clinical nutrition team. Four SCIC, contributing 49% of the SCI beds in the UK, participated in part 2 of the study from July 2009 to March 2010. One hundred and fifty patients (aged 18–88, median: 16.9, 30.7% female) were studied after obtaining written informed consent. The Malnutrition MUST score, baseline clinical data, anthropometric measurements and blood biochemistry were assessed within 96 h of admission. Differences between independent groups were assessed with the Mann–Whitney test. The risk of undernutrition was defined from a MUST score ‡ 1 and overweight was defined from BMI ‡ 25 and ‡ 30 as obese. The present study found that 45.9% of patients were overweight and 15.3% were obese; the prevalence of undernutrition risk was 44.3%. Patients who were at risk of undernutrition were found to have significantly reduced total protein, albumin, Mg, creatinine, Hb, BMI, appetite and significantly higher C-reactive protein, and received more prescribed medications. The process of nutrition risk screening varied between SCIC and may lead to under-detection and under-management. The very high percentage of SCI patients who are at risk of malnutrition is worrying, given the adverse consequences for shortand long-term health and well-being. Strategies for systematic screening and treatment of malnutrition in SCI patients need to be refined and implemented. Further research on the best combinations of simple clinical indices relevant to patients with SCI is warranted.