The Impact of Trained Volunteer Mealtime Assistants on the Dietary Intake of Older Female In-Patients: The Southampton Mealtime Assistance Study.

OBJECTIVE: Malnutrition among older hospital inpatients is common and is associated with poor clinical outcomes. Time-pressured staff may struggle to provide mealtime assistance. This study aimed to evaluate the impact of trained volunteer mealtime assistants on the dietary intake of older inpatients. DESIGN: Quasi-experimental two year pre and post- test study of the introduction of volunteer mealtime assistants to one acute medical female ward, with contemporaneous comparison with a control ward. SETTING: Two acute medical female wards in a university hospital in England. PARTICIPANTS: Female acute medical inpatients aged 70 years and over who were not tube fed, nil by mouth, terminally ill or being nursed in a side room. INTERVENTION: The introduction of volunteer mealtime assistants to one ward to help patients during weekday lunchtimes in the intervention year. MEASUREMENTS: Patients' background and clinical characteristics were assessed; 24-hour records were completed for individual patients to document dietary intake in both years on the two wards. RESULTS: A total of 407 patients, mean (SD) age 87.5 (5.4) years, were studied over the two-year period; the majority (57%) needed mealtime assistance and up to 50% were confused. Patients' clinical characteristics did not differ between wards in the observational or intervention years. Throughout the intervention year volunteers provided mealtime assistance on weekday lunchtimes on the intervention ward only. Daily energy (median 1039 kcal; IQR 709, 1414) and protein (median 38.9 g: IQR 26.6, 54.0) intakes were very low (n=407). No differences in dietary intake were found between the wards in the observational or intervention years, or in a pre-post-test comparison of patients on the intervention ward. Data were therefore combined for further analysis to explore influences on dietary intake. In a multivariate model, the only independent predictor of energy intake was the feeding assistance required by patients; greater need for help was associated with lower energy intake (P<0.001). Independent predictors of protein intake were the feeding assistance given (P<0.001) and use of sip feeds; sip feed users had slightly higher protein intakes (P=0.014). CONCLUSIONS: Trained volunteers were able to deliver mealtime assistance on a large scale in an effective and sustainable manner, with the potential to release time for nursing staff to complete other clinical tasks. The study participants had a low median intake of energy and protein highlighting the importance of patient factors associated with acute illness; a stratified approach including oral and parenteral nutritional supplementation may be required for some acutely unwell patients. The level of mealtime assistance required was the factor most strongly associated with patients' poor intake of energy and protein and may be a useful simple indicator of patients at risk of poor nutrition.

Measuring Appetite with the Simplified Nutritional Appetite Questionnaire Identifies Hospitalised Older People at Risk of Worse Health Outcomes.

OBJECTIVES: Poor appetite is commonly reported by older people but is rarely measured. The Simplified Nutritional Appetite Questionnaire (SNAQ) was validated to predict weight loss in community dwelling older adults but has been little used in hospitals. We evaluated it in older women on admission to hospital and examined associations with healthcare outcomes. DESIGN: Longitudinal observational with follow-up at six months. SETTING: Female acute Medicine for Older People wards at a University hospital in England. PARTICIPANTS: 179 female inpatients. MEASUREMENTS: Age, weight, Body Mass Index (BMI), grip strength, SNAQ, Barthel Index Score, Mini Mental State Examination (MMSE), Geriatric Depression Scale: Short Form (GDS-SF), Malnutrition Universal Screening Tool (MUST), category of domicile and receipt of care were measured soon after admission and repeated at six month follow-up. The length of hospital stay (LOS), hospital acquired infection, readmissions and deaths by follow-up were recorded. RESULTS: 179 female participants mean age 87 (SD 4.7) years were recruited. 42% of participants had a low SNAQ score (<14, indicating poor appetite). A low SNAQ score was associated with an increased risk of hospital acquired infection (OR 3.53; 95% CI: 1.48, 8.41; p=0.004) and with risk of death (HR 2.29; 95% CI: 1.12, 4.68; p = 0.023) by follow-up. CONCLUSION: Poor appetite was common among the older hospitalised women studied, and was associated with higher risk of poor healthcare outcomes.

Reaction kinetics and modeling of the enzyme-catalyzed production of lactosucrose using beta-fructofuranosidase from Arthrobacter sp. K-1.

Lactosucrose synthesis from sucrose and lactose was carried out by using beta-fructofuranosidase from Arthrobacter sp. K-1. The transfructosylation mechanism was found to be of an ordered bi-bi type in which sucrose was bound first to the enzyme and lactosucrose was released last. Hydrolysis side-reaction experiments indicated that the reactions were uncompetitively inhibited by glucose and lactose, while no inhibition by fructose was apparent. The overall reaction rates were formulated. The reaction rate constants, equilibrium constant, and dissociation and Michaelis constants were determined at 35 degrees C and 50 degrees C by fitting the experimental concentration changes with the calculated values by a nonlinear least-square method. The average relative derivation for the concentrations was 9.67%. The kinetic parameters were also calculated for 43 degrees C and 60 degrees C by assuming the Arrhenius law, and the course of reaction was predicted. The obtained reaction rate equations well represented the concentration changes during the experiment at all temperatures.

Comparative safety and tolerability of clopidogrel and aspirin: results from CAPRIE. CAPRIE Steering Committee and Investigators. Clopidogrel versus aspirin in patients at risk of ischaemic events.

OBJECTIVE: The objective of this study was to provide a comprehensive comparison of the long term safety and tolerability of clopidogrel, a new adenosine diphosphate (ADP) receptor antagonist that inhibits platelet activation induced by ADP, and aspirin (acetylsalicylic acid). PATIENTS AND METHODS: The study population comprised 19,185 patients with symptomatic atherosclerosis manifested as recent ischaemic stroke, recent myocardial infarction or symptomatic peripheral arterial disease. Patients were randomised to receive clopidogrel 75 mg/day or aspirin 325 mg/day for a minimum of 1 year and a maximum of 3 years. RESULTS: Compared with aspirin, clopidogrel reduced the combined risk of ischaemic stroke, myocardial infarction or vascular death by 8.7% (p = 0.043). The incidence of early permanent discontinuations of the study drug due to adverse events was almost identical in both treatment groups (11.94% for clopidogrel vs 11.92% for aspirin). Reported neutropenia was similar in the clopidogrel and aspirin groups (0.10 vs 0.17%, respectively) with corresponding rates (0.05 vs 0.04%, respectively) for severe neutropenia. Thrombocytopenia was identical in the clopidogrel and aspirin groups (0.26%), with the rates of severe thrombocytopenia being 0.19 vs 0.10%, respectively. None of these observed differences was statistically significant. The overall incidence of haemorrhagic events did not differ statistically significantly between treatment groups (9.27% for clopidogrel vs 9.28% for aspirin; p = 0.98). There was a trend towards a lower incidence of intracranial haemorrhage in the clopidogrel group (0.31%) compared with the aspirin group (0.42%). Any reported gastrointestinal haemorrhage was significantly less frequent with clopidogrel (1.99%) than with aspirin (2.66%) [p < 0.002]. The corresponding data for severe gastrointestinal bleeding were 0.49 vs 0.71%; p < 0.05. Overall, there were significantly fewer gastrointestinal adverse events with clopidogrel than with aspirin (27.1 vs 29.8%; p < 0.001), with less abdominal pain, dyspepsia, constipation, or peptic, gastric, or duodenal ulceration with clopidogrel. Diarrhoea was significantly more common in the clopidogrel group (4.46 vs 3.36%; p < 0.001), although the incidence of severe diarrhoea (0.23 vs 0.11%) was low and was not significantly different between groups. There were significantly more patients with rash in the clopidogrel group (6.0%) compared with the aspirin group (4.6%) [p < 0.001]. However, these events were generally mild and transient in nature. CONCLUSION: Given the favourable benefit/risk ratio, clopidogrel represents a clinically important advance in the treatment of patients with manifest atherosclerotic disease.

Shall we dance?

Abstract This paper looks at the way in which linguistics has been used in the analysis of identity and suggests that we might now be able to go beyond linguistics and do a wider analysis of identity using performance. I look at race and sex/gender in the context of sexuality and, as a part of my argument, I suggest that processes of identification should not be analyzed as separable but rather as interlocking elements, making up the complete human being. At the end of this mainly theoretical piece, I begin to apply my theory, looking at the work of two of my doctoral research project participants, Patience Agbabi and Zahid Dar, performers of pieces which raise a number of questions about sexuality, performance and identification processes.

Neutralizing antibody responses to human immunodeficiency virus type 1 in primary infection and long-term-nonprogressive infection.

The role of neutralizing antibodies in human immunodeficiency virus type 1 (HIV-1) infection is poorly understood and was assessed by evaluating responses at different stages of infection. Undiluted sera from long-term nonprogressors (LTNP) had broad neutralizing antibodies against heterologous primary isolates and were more likely to neutralize the contemporaneous autologous isolate than were sera from short-term nonprogressors and progressors. In primary infection, envelope-specific IgG was detected before the initial decline in plasma viremia, but neutralizing antibodies developed more slowly. Here, neutralizing antibodies against strains SF-2 and MN were sometimes the first to be detected, but titers were low for at least 17 weeks from onset of symptoms. Neutralizing antibodies against the early autologous isolate were detected for 4 patients by 5-40 weeks but were undetectable in 2 additional patients for 27-45 weeks. The results indicate that neutralizing antibody responses are slow to develop during primary infection and are uniquely broad in LTNP.

A comparison of subcutaneous sumatriptan and dihydroergotamine nasal spray in the acute treatment of migraine.

We compared the efficacy and safety of subcutaneous (SC) sumatriptan (6 mg) with that of dihydroergotamine (DHE) nasal spray (1 mg plus optional 1 mg) in the acute treatment of migraine. Two hundred sixty-six adult migraineurs (International Headache Society criteria) completed a multicenter, double-blind, double-dummy, cross-over study. Patients took SC sumatriptan for one attack and DHE nasal spray for the other in random order. Data from both treatment periods show that at all time points from 15 minutes, SC sumatriptan was significantly better than DHE nasal spray at providing both headache relief (moderate/severe headache improving to mild/none) and resolution of headache. Similarly, SC sumatriptan was superior to DHE nasal spray for the other efficacy end points assessed in the study. Patients reported that both treatments were well tolerated. Adverse events were reported by 43% of patients taking SC sumatriptan and 22% of patients taking DHE nasal spray. These were usually mild and transient. We conclude that subcutaneous sumatriptan has a faster onset of action than DHE nasal spray and provides greater relief of acute migraine symptoms.

Preemptive oral treatment with sumatriptan during a cluster period.

This multinational, multicenter, randomized, double-blind, placebo-controlled study in 169 patients investigated the effect of a 7-day period of preemptive treatment with oral sumatriptan (100 mg tid) on the frequency and severity of cluster headache attacks occurring during an established cluster headache period. Safety and tolerability were also assessed. Cluster headache patients who were not taking prophylactic medication and had experienced seven or more attacks in the preceding observation week, treated a cluster headache attack at home with subcutaneous sumatriptan 6 mg using an autoinjector device. Patients were then randomized to take sumatriptan 100 mg or placebo at 8-hourly intervals for a 7-day period. Cluster headaches occurring during this period could be treated 5 minutes after onset with rescue medication (100% oxygen or simple analgesics). Diary cards were used to record details of the cluster headache pattern during the observation and study treatment weeks. Preemptive oral treatment with sumatriptan 100 mg tid for 7 days did not produce a significant reduction in the number or severity of cluster headache attacks occurring during an established cluster headache period. Oral treatment with sumatriptan 100 mg tid over a 7-day period was not associated with an increased or altered adverse event profile from that previously reported.

Early-phase clinical trials in migraine: efficacy, safety and dose-finding.

Early-phase clinical trials with any new chemical entity have three main objectives: to establish that the drug is effective in the target disease and patient population; to assess tolerability and safety; and to select the optimum dose or doses for further evaluation. Clinical trials in migraine and other headache disorders pose additional problems because of the lack of specific objective diagnostic tests and the reliance on patient assessments of symptom relief. For these reasons particular care must be taken in selection of patients, design of the trials, choice of end-points and statistical analytical methodology. A wide range of doses must be evaluated to ensure that the dose-response curves for both efficacy and safety/tolerability are fully defined. Successful early-phase trials should then allow the optimum dose or doses of the drug to be identified for further evaluation in large-scale outpatient studies.

Cluster headache attacks treated for up to three months with subcutaneous sumatriptan (6 mg). Sumatriptan Cluster Headache Long-term Study Group.

In the first three months of a 24-month open study to assess the safety and efficacy of subcutaneous sumatriptan 6 mg in the long-term acute treatment of cluster headache, 138 patients treated a maximum of two attacks daily each with a single 6 mg injection. A total of 6353 attacks were treated. Adverse events, reported in 28% of sumatriptan-treated attacks, were qualitatively similar to those seen in migraine long-term trials. Their incidence did not increase with frequent use of sumatriptan. There were no clinically significant treatment effects on vital signs, ECG recordings or laboratory parameters. Headache relief (a reduction from very severe, severe or moderate pain to mild or no pain) at 15 min was obtained for a median of 96% of attacks treated. There was no indication of tachyphylaxis, decrease in the speed of response, or increased frequency of attacks with long-term treatment. This study demonstrated that, in long-term use, subcutaneous sumatriptan 6 mg is a well-tolerated and effective acute treatment for cluster headache.

[Sumatriptan treatment of migraine in general practice. A randomized, double-blind, placebo-controlled cross-over study]. / Sumatriptan ved migraene i almen praksis. En randomiseret, dobbeltblind, placebokontrolleret overkrydsningsundersøgelse.

Two hundred and thirty migraineurs diagnosed by their general practitioners in accordance with their usual practice were included. The patients treated two migraine attacks at home by subcutaneous injection of sumatriptan or placebo and the alternative medication for the second attack (cross-over). When sumatriptan was compared to placebo, significantly more of the 209 evaluable patients reported headache relief at one hour (56% v 8%, p < 0.001) and two hours (62% v 15%, p < 0.001) after the first injection. Resolution of nausea, photophobia and phonophobia was significantly more common in patients on sumatriptan than on placebo (p < 0.001 for all comparisons). The adverse events were usually transient and of mild or moderate severity, although, three patients withdrew due to adverse events. Ninety-five percent of patients evaluated by a neurological research fellow met the International Headache Society's criteria for migraine. In general practice, sumatriptan taken subcutaneously using an autoinjector at home was an effective and well tolerated acute treatment for migraine.

Oral sumatriptan: effect of a second dose, and incidence and treatment of headache recurrences.

Oral sumatriptan in a dose of 100 mg aborts about 60% of migraine attacks within 2 h, but the headache may recur within 24 h. We investigated: (i) the incidence of headache recurrence after oral sumatriptan (ii) whether a second tablet of sumatriptan at 2 h increases initial efficacy and/or (iii) prevents headache recurrence and (iv) whether a further tablet of sumatriptan treats headache recurrence. In a randomized parallel-group clinical trial, 1246 patients treated one to three migraine attacks (with or without aura), with 100 mg oral sumatriptan. Two hours later they all took a double-blind randomized second table of sumatriptan (group I) or placebo (group II). Patients who initially improved, but then experienced headache recurrence took a further double-blind randomized tablet of sumatriptan or placebo. Proportions of patients who improved from moderate/severe headache to mild/none were similar in groups I and III at 2 h (55 vs 56%) and 4 h (80 vs 77%). Incidences of headache recurrence (moderate/severe-any grade of headache) and median times to headache recurrence were also similar: 22-32% at 16 h in group I and 25-33% at 16.5 h in group II. Sumatriptan was superior to placebo in treating headache recurrence: 74 vs 49% (p = 0.017) in group I and 70 vs 30% (p = 0.0001) in group II. Thus, one-fourth of patients experience headache recurrence at about 16 h after successful treatment of a migraine attack with 100 mg oral sumatriptan. A second tablet of sumatriptan at 2 h does not increase initial efficacy and neither prevents nor delays headache recurrence.(ABSTRACT TRUNCATED AT 250 WORDS)

Subcutaneous sumatriptan during the migraine aura. Sumatriptan Aura Study Group.

This double-blind, placebo-controlled, multicenter, parallel-group study assessed whether subcutaneous sumatriptan administered during the migraine aura would prolong or modify the aura and prevent or delay development of the headache. One hundred seventy-one patients (88 receiving 6 mg sumatriptan, 83 receiving placebo) treated a single attack of migraine with typical aura at home, by self-injection. The median duration of aura following the first injection was 25 minutes for the sumatriptan group and 30 minutes for the placebo group (NS). The aura symptom profile was similar for the two treatment groups. The proportion of patients who developed a moderate or severe headache within 6 hours after dose administration was similar in the two groups--68% among those receiving sumatriptan and 75% among those receiving placebo (NS). Sumatriptan given during the aura did not prolong or alter the nature of the migraine aura and did not prevent or significantly delay headache development.

A randomized double-blind placebo-controlled crossover study of subcutaneous sumatriptan in general practice.

OBJECTIVE: To evaluate the therapeutic response to sumatriptan in the acute migraine attack, MATERIAL AND METHODS: Two hundred and thirty migraineurs diagnosed by their general practitioners in accordance with their usual practice were included in the study. The patients treated two migraine attacks at home by subcutaneous injection of sumatriptan or placebo for the first attack and the alternative medication, i.e. placebo or sumatriptan, for the second attack (crossover). Following treatment, a neurology resident interviewed and examined the patients. RESULTS: When sumatriptan was compared to placebo, significantly more of the 209 evaluable patients reported headache relief at 1 h (56% vs 8%, p < 0.001) and 2 h (62% vs 15%, p < 0.001) after the first injection. Resolution of nausea, photophobia, and phonophobia was significantly more common in patients on sumatriptan than in those on placebo (p < 0.001 for all comparisons). The adverse events were usually transient and of mild or moderate severity; however, three patients withdrew due to adverse events. Ninety-five percent of patients evaluated by a neurology resident met the IHS criteria for migraine. CONCLUSION: In general practice, sumatriptan taken subcutaneously using an autoinjector at home was an effective and well tolerated acute treatment for migraine.

The clinical profile of sumatriptan: efficacy in migraine.

The efficacy of the 5-HT1 receptor agonist sumatriptan in the acute treatment of migraine has been investigated in an extensive programme of controlled clinical trials. Sumatriptan provided rapid relief from migraine headache with onset of relief occurring within 10 min of a 6 mg subcutaneous injection and within 30 min of a 100 mg oral dose. Maximum benefit was observed by 2 h after the injection and 4 h after the oral dose. Sumatriptan also significantly decreased the incidence of associated migraine symptoms (nausea, photophobia, phonophobia) and the need for rescue medication. Sumatriptan was an effective treatment for migraine with and without aura and when used at any time during the attack. Oral sumatriptan 100 mg provided significantly greater pain relief and had a more rapid onset of action than two commonly used acute treatments for migraine. Efficacy is maintained in long-term use, with no evidence of tachyphylaxis or dependence. Sumatriptan, whether given subcutaneously or orally, is an effective long-term acute treatment for migraine.

Subcutaneous sumatriptan in the acute treatment of cluster headache: a dose comparison study. The Sumatriptan Cluster Headache Study Group.

This multicentre, double-blind, randomised, crossover study compared the efficacy, safety and tolerability of subcutaneous sumatriptan (6 mg and 12 mg) with placebo in 134 in-patients with cluster headache. Headache improvement to mild or no pain at 5, 10 and 15 min after treatment was recorded. At 10 min, headache relief was reported by 25% (placebo), 49% (6 mg) and 63% (12 mg) of patients and at 15 min the results were 35% (placebo), 75% (6 mg) and 80% (12 mg) (p < 0.001 for all comparisons with placebo). The 12 mg dose was not significantly better than the 6 mg dose and was associated with more adverse events. The 6 mg dose is therefore recommended for the acute treatment of cluster headache.

The safety of sumatriptan in asthmatic migraineurs.

A recent report has questioned the safety of sumatriptan in asthmatic migraineurs. To investigate this, we have reviewed the sumatriptan clinical trial safety database of over 75 completed trials. Within the clinical trial database, 375 asthmatic patients were identified who treated 1214 migraine attacks with sumatriptan. The incidence and nature of adverse events in the asthmatic patient subgroup who received sumatriptan was similar to that in the complete clinical trial population. Six reports of asthma were recorded as adverse events, but only one case was classified by the investigator as related to treatment. There is no clinical or pharmacological evidence to suggest that the safety profile of sumatriptan is altered in asthmatic patients compared to other migraine sufferers.

Long-term experience with sumatriptan in the treatment of migraine.

Sumatriptan, a specific 5-hydroxytryptamine agonist, is a novel acute treatment for migraine. The efficacy and safety profiles of sumatriptan have previously been demonstrated in several controlled short-term studies. However, because migraine is a recurrent disorder which may persist throughout adult life, sustained efficacy and tolerability are essential if sumatriptan is to be of value in clinical practice. These aspects were therefore evaluated in a programme of three 12-month studies. Sustained efficacy with long-term use of single 100-mg oral doses has been demonstrated in an open study in which 288 patients treated 8,094 migraine attacks. The long-term safety profile of oral and subcutaneous sumatriptan has been evaluated in a total of 849 patients who treated 24,907 migraine attacks in studies lasting up to 1 year. Sumatriptan was well tolerated. Adverse events did not differ qualitatively or quantitatively from those in short-term studies, irrespective of the frequency of attacks or the number of doses used. Migraine attacks were effectively treated with doses less than the recommended maximum and there was no evidence of any adverse effect on attack frequency. In long-term studies the high efficacy of sumatriptan is maintained, and the adverse event profile is unchanged and unaffected by attack frequency.

Sumatriptan in the acute treatment of migraine.

Sumatriptan is a selective 5-HT1-like agonist, which is effective in the treatment of migraine and cluster headache. It has been rigorously assessed in clinical trials involving over 7000 patients who have treated over 35,000 migraine attacks. Both subcutaneous and oral sumatriptan provide a high level of efficacy with 86% of patients obtaining relief after a single 6 mg injection (at 2 h) and 75% after 100 mg oral sumatriptan (4 h), compared with up to 37% in the placebo-treated group (P < 0.001). The onset of effect is rapid, occurring 10 min after injection and 30 min after the tablet. Oral sumatriptan (100 mg) has been evaluated against ergotamine, 2 mg, plus caffeine, 200 mg (as Cafergot); and against aspirin, 900 mg, plus metoclopramide, 10 mg. Headache relief was superior in sumatriptan-treated patients; 66% obtaining relief at 2 h, compared with 48% on Cafergot (P < 0.001). The percentage of patients obtaining complete relief of headache (Grade 0, no pain) was significantly higher with sumatriptan (40%) than with Cafergot (14%) at 2 h. Associated symptoms such as nausea, vomiting and photophobia are effectively relieved by sumatriptan, whereas Cafergot provoked nausea and vomiting in a proportion of patients. Headache relief with sumatriptan was also superior to that seen with aspirin plus metoclopramide. Sumatriptan was as effective in the relief of accompanying nausea and vomiting as aspirin plus metoclopramide. The efficacy of sumatriptan is maintained after repeated long-term use; over a six-month period efficacy was comparable in the first and last attacks, regardless of how many attacks were treated.(ABSTRACT TRUNCATED AT 250 WORDS)