Challenges and opportunities of sharing animal health data for research and disease management: a case study of bovine tuberculosis.

The sharing of animal disease data should be encouraged. The analysis of such data will broaden our knowledge of animal diseases and potentially provide insights into their management. However, the need to conform to data protection rules in the sharing of such data for analysis purposes often poses practical difficulties. This paper sets out the challenges and the methods used for the sharing of animal health data in England, Scotland and Wales - Great Britain - using bovine tuberculosis (bTB) data as a case study. The data sharing described is undertaken by the Animal and Plant Health Agency on behalf of the Department for Environment, Food and Rural Affairs and the Welsh and Scottish Governments. It should be noted that animal health data are held at the level of Great Britain (rather than the United Kingdom - which includes Northern Ireland), as Northern Ireland's Department of Agriculture, Environment and Rural Affairs has its own separate data systems. Bovine tuberculosis is the most significant and costly animal health problem facing cattle farmers in England and Wales. It can be devastating for farmers and farming communities and the control costs for taxpayers in Great Britain are over £150 million a year. The authors describe two methods of data sharing - first, where data are requested by, and delivered to, an academic institution for epidemiological or scientific analysis, and second, where data are proactively published in an accessible and meaningful way. They provide details of an example of the second method, namely, the free-to-access website â€Ëœinformation bovine TB' (https://ibtb.co.uk), which publishes bTB data for the benefit of the farming community and veterinary health professionals.

L'échange et le partage de données sur les maladies animales sont des pratiques à encourager. En effet, l'analyse de ces données permet d'étoffer les connaissances sur les maladies animales et peut aussi apporter un nouvel éclairage sur leur gestion. Néanmoins, la nécessité de se conformer aux règles sur la protection des données pose souvent des difficultés pratiques lors des échanges de ce type de données à des fins d'analyse. Les auteurs expliquent les difficultés rencontrées en matière d'échange de données de santé animale en Angleterre, en écosse et au Pays de Galles (Grande-Bretagne), ainsi que les méthodes utilisées, à partir de l'exemple concret des données relatives à la tuberculose bovine. L'échange et le partage de données sont réalisés par l'Agence britannique de santé animale et végétale, pour le compte du ministère britannique de l'Environnement, de l'Alimentation et des Affaires rurales et des gouvernements gallois et écossais. Il convient de préciser que les données de santé animale dont il s'agit sont celles conservées au niveau de la Grande-Bretagne seulement (et non du Royaume-Uni, qui inclut l'Irlande du Nord), étant donné que le ministère de l'Agriculture, de l'Environnement et des Affaires rurales de l'Irlande du Nord possède ses propres systèmes de données. La tuberculose bovine est le principal problème de santé animale auquel sont confrontés les éleveurs de bovins en Angleterre et au Pays de Galles, et le plus coûteux à traiter. La survenue de la tuberculose bovine est une catastrophe pour les éleveurs affectés et leur communauté. En outre, le coût annuel de son contrôle s'élève à plus de 150 millions de livres pour le contribuable britannique. Les auteurs décrivent deux méthodes d'échange et de partage de données : la première est celle où une institution de recherche demande et obtient l'accès à des données particulières afin de réaliser une étude épidémiologique ou scientifique ; la deuxième consiste à publier les données de manière proactive et constructive, en les rendant facilement accessibles. Un exemple concret de cette deuxième méthode est décrit en détail : il s'agit du site web d'information sur la tuberculose bovine (https://ibtb.co.uk), d'accès libre, qui diffuse des informations sur cette maladie à l'intention des éleveurs et des professionnels de la santé animale.

Convendría alentar la puesta en común de datos zoosanitarios, pues el análisis de estos datos nos ayudará a conocer más y mejor las enfermedades animales y, a la postre, puede darnos pistas sobre la mejor manera de afrontarlas. Ocurre a menudo, sin embargo, que el prescriptivo cumplimiento de las reglas de protección de datos plantee dificultades prácticas para poner estos datos en común con fines de análisis. Los autores, empleando como ejemplo un estudio sobre la tuberculosis bovina, describen esas dificultades y los métodos utilizados para compartir datos zoosanitarios en Inglaterra, Escocia y Gales (Gran Bretaña). En el ejemplo descrito, la Agencia de Sanidad Animal y Vegetal del Reino Unido fue la instancia que impulsó la puesta en común de los datos en nombre del Departamento de Medio Ambiente, Alimentación y Asuntos Rurales del Reino Unido y de los gobiernos galés y escocés. Conviene puntualizar que los datos zoosanitarios cubren el territorio de Gran Bretaña (y no de todo el Reino Unido, que incluye Irlanda del Norte), ya que el Departamento de Medio Ambiente, Alimentación y Asuntos Rurales norirlandés dispone de su propio sistema de datos independiente. La tuberculosis bovina es el problema zoosanitario más importante y oneroso al que hacen frente las explotaciones de vacuno en Inglaterra y Gales. Esta enfermedad no solo puede ser devastadora para los productores y profesionales del sector, sino que la lucha contra ella cuesta al contribuyente británico más de 150 millones de libras al año. Los autores describen dos métodos para compartir de datos: en el primero de ellos, un establecimiento universitario solicita y recibe los datos con fines de análisis científico o epidemiológico; en el segundo, una entidad toma la iniciativa de hacer públicos los datos de forma accesible y coherente. Los autores exponen en detalle un ejemplo del segundo procedimiento, a saber, el sitio web de información sobre la tuberculosis bovina (https://ibtb.co.uk) en libre acceso, en el cual se publican datos sobre la enfermedad dirigidos a los profesionales del sector pecuario y la sanidad animal.

Reduction of breast lymphoedema secondary to breast cancer: a randomised controlled exercise trial.

BACKGROUND: Breast lymphoedema can occur following surgical treatment for breast cancer. We investigated whether an exercise program reduced breast lymphoedema symptoms compared to a non-exercise control group. METHODS: A single-blinded randomised controlled trial was conducted in which women with stable breast lymphoedema (n = 89) were randomised into an exercise (n = 41) or control (n = 47) group. The intervention comprised a 12-week combined aerobic and resistance training program, supervised weekly by an accredited exercise physiologist. All participants completed a weekly symptoms diary and were assessed monthly to ensure that there was no exacerbation of their lymphoedema. Changes in the breast were captured physically with ultrasound and bioimpedance spectroscopy and changes in symptoms were captured using European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer (BR23) and Lymphoedema Symptom Intensity and Distress questionnaires. RESULTS: The exercise group reported a greater reduction in breast-related symptoms than the control group, assessed by the EORTC BR23 breast symptom questions. Measures of extracellular fluid, assessed with bioimpedance spectroscopy ratio, decreased in the exercise group compared to the control group. No significant difference was detected in dermal thickness in the breast, assessed by ultrasound. Session attendance in the exercise sessions was high, with two musculoskeletal adverse events reported, but no exacerbations of lymphoedema observed. CONCLUSION: Combined resistance and aerobic exercise training is safe for women living with breast lymphoedema. Preliminary data suggest exercise training can reduce breast lymphoedema symptoms to a greater extent than usual care.

WITHDRAWN: Acute effects of a high-volume resistance training session on lung function.

Ahead of Print article withdrawn by publisher.

Respiratory muscle adaptations: a comparison between bodybuilders and endurance athletes.

AIM: The purpose of this study was to compare the respiratory muscle and lung function measures of bodybuilders (BB) and endurance athletes (EA). METHODS: Forty-two male subjects (22 BB and 20 EA) aged 20-35 years underwent respiratory muscle strength measurements (MIP and MEP), lung function testing (FEV1, FVC, FEV1/FVC%, IC, ERV, FRC, RV, and TLC), hydrostatic weighing and VO2max testing. One-repetition maximum (1RM) for bench press, squat and deadlift was performed by BB. RESULTS: BB had significantly greater MIP and MEP compared to EA by 43% and 53% respectively (P<0.01). Moderate correlation was found for MEP and 1RM bench press (P<0.01), and weak correlations found for the squat and deadlift (P<0.01). Fat-free mass was significantly greater for BB compared with EA (P<0.01), while VO2max was significantly greater for EA compared with BB (P<0.01). No differences in lung function indices were observed between groups. CONCLUSION: When compared to EA, BB exhibited significantly greater respiratory muscle strength. The maximal load lifted for bench press predicted expiratory muscle strength gain. Lung function measures did not differ between the groups.

Lisdexamfetamine and immediate release d-amfetamine - differences in pharmacokinetic/pharmacodynamic relationships revealed by striatal microdialysis in freely-moving rats with simultaneous determination of plasma drug concentrations and locomotor activity.

Lisdexamfetamine mesylate (Vyvanse(®)) is a novel prodrug approved for attention deficit hyperactivity disorder (ADHD). It is metabolised to d-amfetamine and l-lysine. In drug-experienced humans, lisdexamfetamine evoked lower "Drug liking" scores on Drug Rating Questionnaire (DRQ) scales than immediate-release (IR) d-amfetamine. This study investigated why lisdexamfetamine may have lower abuse potential and a better therapeutic window than d-amfetamine. We compared the pharmacokinetic/pharmacodynamic relationships of lisdexamfetamine and IR d-amfetamine in freely-moving rats by measuring simultaneously extracellular concentrations of striatal dopamine, plasma concentrations of d-amfetamine and lisdexamfetamine, and locomotor activity. At equivalent doses (1.5 mg/kg d-amfetamine base), lisdexamfetamine produced smaller, but more sustained, increases in striatal dopamine efflux than d-amfetamine and substantially less locomotor activation. Consistent with it being a prodrug, increased striatal dopamine and locomotion correlated with plasma concentration of its metabolite, d-amfetamine, but not the parent compound. Compared with IR d-amfetamine, lisdexamfetamine produced an identical AUC for plasma d-amfetamine, but a 50% lower C(max) and significantly delayed t(max). Where a hysteresis relationship did exist between plasma concentrations of d-amfetamine and striatal dopamine or locomotor activity, they were anticlockwise in direction for lisdexamfetamine and IR d-amfetamine. For extracellular striatal dopamine (neurochemical mediator) and locomotor activity (functional outcome), it was anticlockwise for lisdexamfetamine, but clockwise for IR d-amfetamine. This shows that lisdexamfetamine produced less pronounced behavioural activation as dopamine concentrations increased, but activity was maintained for longer when they declined. These findings help explain why the unusual pharmacokinetics of lisdexamfetamine evoked lower "Drug liking" scores than IR d-amfetamine and also suggest therapeutic window between efficacy and stimulant side-effects will be larger.

Outcomes of elderly patients aged 80 and over with symptomatic, severe aortic stenosis: impact of patient's choice of refusing aortic valve replacement on survival.

BACKGROUND: Aortic valve replacement (AVR) can be performed safely in selected elderly patients with aortic stenosis (AS). However, the survival benefits of AVR over conservative treatment have not been convincingly demonstrated in AS patients aged above 80. AIM: To investigate the outcomes of patients aged 80 and over with symptomatic, severe AS and by analyzing the effects of patient's choice in either agreeing or refusing to undergo AVR, determine the survival benefits afforded by AVR. DESIGN: Cohort study. METHODS: Subjects aged 80 and over with severe symptomatic AS, diagnosed between 2001 and 2006 were segregated into three groups: subjects who underwent AVR (Group A); patients who were fit for AVR but declined surgery due to personal choice (Group B) and those who were not fit for surgery and were managed conservatively (Group C). Follow-up was conducted by out-patient attendances, review of medical records and telephone interviews. The primary endpoint was all-cause mortality. RESULTS: A total of 103 patients (86.0 +/- 4.2 years, 41% male) were identified and no patient was lost during follow-up. In Group A (n = 17), all 15 patients who underwent AVR were alive after 3.6 +/- 1.4 years follow-up and 2 died whilst awaiting AVR. Seventy-four percent of Group B (n = 24) and 76% of Group C (n = 62) died during follow-up. Group A had significantly better survival than B and C. (P < 0.01) Amongst patients fit for AVR with similar operative risks (Groups A and B), refusal to undergo surgery (hazard ratio 12.61, P = 0.001) was the only predictor of mortality in a multivariate model. CONCLUSION: For elderly AS patients fit for surgery, the patient's decision to refuse AVR is associated with a >12-fold increase in mortality risk. These findings have significant implications for informed decision-making when managing the fit, elderly patient with AS.

Role of non-invasive imaging in the management of coronary artery disease: an assessment of likely change over the next 10 years. A report from the British Cardiovascular Society Working Group.

Coronary angiography has been the gold standard for determining the severity, extent and prognosis of coronary atheromatous disease for the past 15-20 years. However, established non-invasive testing (such as myocardial perfusion scintigraphy and stress echocardiography) and newer imaging modalities (multi-detector x ray computed tomography and cardiovascular magnetic resonance) now need to be considered increasingly as a challenge to coronary angiography in contemporary practice. An important consideration is the degree to which appropriate use of such techniques impacts on the need for coronary angiography over the next 10-15 years. This review aims to determine the role of the various investigation techniques in the management of coronary artery disease and their resource implications, and should help determine future service provision, accepting that we are in a period of significant technological change.

Two items on the Hamilton Depression rating scale are effective predictors of remission: comparison of selective serotonin reuptake inhibitors with the combined serotonin/norepinephrine reuptake inhibitor, venlafaxine.

Recent studies have shown that the use of subscales derived from the Hamilton Depression (HAM-D) rating scale are just as reliable and enhance sensitivity for detecting response and remission after antidepressant treatment. The purpose of the present study was to determine if the responses on two items of the HAM-D scale, Depressed Mood (item 1) and Psychic Anxiety (item 10), were predictive of remission of depression in placebo-controlled studies following treatment with venlafaxine or selective serotonin reuptake inhibitors (SSRIs). Data from eight active- and placebo-controlled studies consisting of 2027 subjects who met the DSM-III-R/-IV criteria for major depressive disorder were analysed. Three treatment groups were compared: venlafaxine (n =843), SSRI (either fluoxetine, paroxetine or fluvoxamine, n=743) and placebo (n=441). Treatment duration was 6-8 weeks. Patients who scored zero on the depressed mood and the psychic anxiety items of the HAM-D17 scale were designated as responders. These two scores were also combined to create an Absence of Depressive and Anxious Mood (ADAM) score. Between-group rate comparisons in outcome measures were carried out using Fisher's exact test and logistic regression models. Venlafaxine treatment improved depressed mood, psychic anxiety and ADAM scores after 2 weeks with greater efficacy than treatment with SSRIs or placebo. ADAM scores could also predict the odds ratio of a patient achieving a clinical remission (defined as total HAM-D17 score

Venlafaxine extended release (ER) in the treatment of generalised anxiety disorder: twenty-four-week placebo-controlled dose-ranging study.

BACKGROUND: Generalised anxiety disorder (GAD) has received less study than other anxiety disorders, particularly its long-term treatment. AIMS: To assess the efficacy and safety of venlafaxine extended release (ER) in patients with GAD. METHOD: A total of 541 out-patients, 18-86 years old, were recruited to this 24-week, placebo-controlled, double-blind study of three fixed doses (37.5, 75 and 150 mg/day) of venlafaxine ER. RESULTS: All doses of venlafaxine ER showed efficacy superior to placebo, apparent from week 2, that was sustained throughout the 24-week study for the two higher doses. The discontinuation rate did not differ significantly among the treatment groups. CONCLUSIONS: Venlafaxine ER is an effective and safe treatment for GAD for up to 6 months.

Pattern of symptom improvement following treatment with venlafaxine XR in patients with generalized anxiety disorder.

BACKGROUND: The efficacy of anxiolytic drugs in generalized anxiety disorder (GAD) is conventionally assessed by evaluating changes in the total score of psychometric scales such as the Hamilton Rating Scale for Anxiety (HAM-A). The purpose of this pooled analysis of data was to evaluate the efficacy of venlafaxine extended release (XR) on individual items of the HAM-A and the Brief Scale for Anxiety (BSA). METHOD: Data were pooled from 5 studies of patients with GAD who were treated with either venlafaxine XR or placebo for 8 weeks (N = 2,021) and up to 6 months (N = 767). Individual items of the HAM-A and the BSA were examined. and, using the mean changes from baseline to endpoint, an effect size for each item was calculated by dividing the difference between baseline and endpoint values for each item by the standard deviation of this difference. The effect sizes determined for the venlafaxine group were compared with those for the placebo group. Items from each scale that are concordant with the DSM-IV diagnostic criteria for GAD were selected for further examination, and the specific effect sizes of each item were expressed after controlling for placebo effects. RESULTS: The effect size of the majority of the 14 items of the HAM-A scale and the 10 items of the BSA scale associated with treatment with venlafaxine XR was greater than with placebo at both 8 weeks and 6 months. Furthermore, the effect sizes at 6 months were generally greater than at 8 weeks in venlafaxine XR-treated patients. Effect sizes associated with venlafaxine XR were greatest for the HAM-A items that were most closely related to diagnostic symptoms of GAD, namely anxious mood, tension, intellectual functioning, and behavior at interview at both 8 weeks and 6 months. Similarly, GAD-related BSA items of inner tension, worrying over trifles, hostile feelings, and muscular tension were associated with the greatest improvements with venlafaxine XR at both time-points. CONCLUSION: The HAM-A and BSA items that most closely corresponded to DSM-IV diagnostic criteria for GAD showed the largest improvement during treatment with venlafaxine XR. This indicates that the specific symptoms of GAD can be treated effectively with venlafaxine XR, both in the short and longer term.

Self-esteem matters: racial & gender differences among rural southern adolescents.

Self-esteem does matter! It matters so much that Oprah dedicated an entire issue of "O" magazine to address the subject. "It's a woman's most treasured possession" (Winfrey, 2000a). Self-esteem has a profound influence on adolescent health promotion behaviors. This study contributes to understanding the role self-esteem plays in the behavior of adolescents. Utilizing a secondary data analysis, race and gender self-esteem differences among adolescents were investigated. The sample of 1,237 students (46% African-American and 52% White) from rural southern areas consisted of 744 females and 493 males. Self-esteem was assessed using the Miller Self-esteem Questionnaire (SEQ). The Hendricks Perceptual Health Promoting Determinants Model (HPHD) provided the theoretical framework for the study. The results of the study revealed a statistically significant difference in various aspects of self-esteem according to race and gender. African-Americans and males had a higher self-esteem which is consistent with many prior studies.

Venlafaxine XR in the treatment of anxiety.

OBJECTIVE: To present the results of numerous studies that assessed the efficacy, safety and tolerability of venlafaxine extended release (XR) in treating anxiety disorders, particularly generalized anxiety disorder (GAD). METHOD: Efficacy was assessed with the Hamilton Rating Scale for Anxiety, Clinical Global Impressions scale, Hospital Anxiety and Depression scale and other instruments. Standard safety and tolerability assessments were used. RESULTS: In four placebo-controlled trials, venlafaxine XR was effective and well tolerated in patients with GAD. Several additional smaller studies found venlafaxine XR effective in treating anxiety associated with social phobia, obsessive-compulsive disorder and panic disorder. CONCLUSION: Venlafaxine XR has both short- and long-term efficacy and tolerability in treating symptoms of long-term anxiety and comorbid anxiety and depression, and in achieving remission in GAD patients. These characteristics, combined with early onset of anxiolytic action and dose response effect, make it a logical choice for treating anxiety occurring alone or comorbidly with depression.

Limitation of coronary reserve after successful angioplasty is prevented by oral pretreatment with an alpha1-adrenergic antagonist.

Coronary vasoconstriction that occurs after percutaneous transluminal coronary angioplasty (PTCA) is abolished by intracoronary phentolamine. An impairment of coronary vasodilator reserve (CVR) has been observed < or = 7 days after successful PTCA. To ascertain whether pretreatment with the alpha1-adrenergic receptor blocker doxazosin could prevent the limitation of CVR after PTCA, we carried out a randomised, double-blind, controlled study on 26 patients with significant (> 75%) single vessel disease undergoing PTCA. Twelve patients received doxazosin 4 mg daily in addition to their standard treatment, while 14 patients received matching placebo, starting 11 days before PTCA. Myocardial blood flow (MBF) at baseline and after i.v. dipyridamole (0.56 mg/kg) was measured within 5 days after PTCA using positron emission tomography (PET) with oxygen-15-labelled water. Angioplasty was successful in all patients with a residual stenosis < or = 35%. At PET scanning, hemodynamic parameters were comparable in the two groups. In the territory subtended by the dilated artery, CVR was significantly higher in patients treated with doxazosin compared with those receiving placebo (2.78 +/- 0.1.21 vs. 1.95 +/- 0.68; p < 0.01). Conversely, CVR in the remote territories subtended by angiographically normal arteries was similar in the two groups (2.53 +/- 0.92 and 2.48 +/- 0.80, respectively; p = NS). Treatment with oral doxazosin in addition to standard antianginal therapy can prevent the impairment of CVR frequently observed despite successful PTCA.

Plasma homocysteine concentrations and risk of coronary heart disease in UK Indian Asian and European men.

BACKGROUND: Reasons for the increase in mortality due to coronary heart disease (CHD) in UK Indian Asians are not well understood. In this study, we tested the hypotheses that elevated plasma homocysteine concentrations are a risk factor for CHD in Indian Asians, and explain part of their increased CHD risk, compared with Europeans. METHODS: We undertook two parallel case-control studies, one in Europeans and one in Indian Asians. We recruited 551 male cases (294 European, 257 Indian Asian) and 1025 healthy male controls (507 European, 518 Indian Asian). Fasting and post-methionine load homocysteine, vitamin B12 and folate concentrations, and conventional CHD risk factors were measured. FINDINGS: Fasting homocysteine concentrations were 8% higher (95% CI 3-14) in cases compared with controls, in both ethnic groups. The odds ratio of CHD for a 5 micromol/L increment in fasting plasma homocysteine was 1.3 (1.1-1.6) in Europeans and 1.2 (1.0-1.4) in Indian Asians. The association between fasting plasma homocysteine and CHD was independent of conventional CHD risk factors in both ethnic groups. Post-load homocysteine concentrations were not significantly different in cases compared with controls. Among the controls, fasting homocysteine concentrations were 6% (2-10) higher in Indian Asians than in Europeans. From the results we estimate that elevated homocysteine may contribute to twice as many CHD deaths in Indian Asians, compared with Europeans. The differences in homocysteine concentrations between the two ethnic groups were explained by lower vitamin B12 and folate levels in Asians. INTERPRETATION: Plasma homocysteine is a novel and independent risk factor for CHD in Indian Asians, and may contribute to their increased CHD risk. Raised homocysteine concentrations in Indian Asians may be related to their reduced vitamin B12 and folate levels, implying that the increased CHD risk in this group may be reduced by dietary vitamin supplementation.

The public's image of nursing as described to baccalaureate prenursing students.

The purpose of this study was to evaluate the perceptions of nursing's image by nonnursing students, professionals, and other nonnursing individuals. Because the image of nursing has been a long-standing problem for nurses, an indication of the overall effectiveness of various individual and group efforts to change the public's image of nursing over the last several years was examined. Content analysis was used to analyze 831 responses to determine the respondent's perceptions of nurses and the nursing profession. Results indicated that the majority of individuals who participated in the study believed that nursing is most closely associated with the concept of caring, even though the meaning and practice of nurse caring was defined very differently.

A randomized, double-blind, parallel-group comparison of venlafaxine and clomipramine in outpatients with major depression.

A multicentre, randomized, double-blind study was conducted to compare the safety and antidepressant efficacy of venlafaxine and clomipramine in 102 outpatients with major depression. The patients received either venlafaxine or clomipramine at a dose titrated from 50 mg to a maximum of 150 mg/day during the first 2 weeks of treatment. Treatment was continued for up to 43 days. Montgomery Asberg Depression Rating Scale (MADRS) and Hamilton Depression Rating Scale (HAM-D) scores decreased significantly (p < or = 0.05) from baseline in each treatment group but were not significantly different between groups. Response rates on the MADRS and HAM-D were 62% and 59%, respectively, with venlafaxine and 54% and 43%, respectively, with clomipramine. Treatment-emergent study events were the primary reason for withdrawal in only 13% of venlafaxine-treated patients and 20% of clomipramine-treated patients. On questionnaires, the incidence of anticholinergic-type events was 60% with venlafaxine and 68% with clomipramine. However, significantly (p = 0.043) more patients in the clomipramine group reported multiple anticholinergic events than in the venlafaxine group. In the clomipramine group, mean ventricular heart rate increased significantly (p = 0.003) and mean systolic blood pressure decreased significantly (p = 0.028) from baseline, but no clinically significant electrocardiographic changes were observed. These results confirm the efficacy and safety of venlafaxine in the treatment of outpatients suffering from major depression.

Comparing onset of effect of antidepressants: Pragmatic considerations on methods and end-points.

There is no accepted definition of what constitutes onset of antidepressant effect, and this limits evaluation of the validity of many comparative reports. In order to clarify the nature of the comparative methodology required, it is proposed that two distinct research questions are separated conceptually: 1) when do antidepressant drugs begin to clinically act? and 2) do all antidepressant drugs produce relief of symptoms in patients within a similar time period? A methodological distinction may also be made in terms of whether to assess the onset of effect of an antidepressant as having an absolute quality ("fast") or as being fast relative to other treatments ("faster"). The choice of aim will help to define the methodological approach, the applicability of the findings and the difficulties to be addressed. Describing an antidepressant as showing a "fast" or "faster" onset of response requires that any description attempts to define (in terms that may be generalised) the nature of the comparison (faster than what?), the nature of the effect (faster to do what?) and the population in whom this effect may be expected (faster in whom?). Some details of methodological approaches are reviewed, and suggestions for study designs are made.

Extracorporeal circuit sterility after 168 hours.

One of the most important tasks of the perfusionist is the proper assembly of the extracorporeal circuit (ECC) prior to the initiation of cardiopulmonary bypass (CPB). The ECC is usually assembled, primed and debubbled 30 minutes to one hour prior to the patient entering the operating room. But there are occasions when the ECC may have been set up and the previously scheduled procedure cancelled. Perfusionists in this situation have found themselves in a quandary; dispose of the ECC because of required nursing compliance and the sterility question, or keep it and use it later because of the economic impact on the "bottom line". Some hospitals may have satisfactorily answered the question of ECC sterility after 24 hours without observation, but the few reported papers regarding this issue, and our desire to save these circuits, inspired us to find out if they were in fact sterile after having been open for a long period of time. The purpose of this study was to evaluate ECC sterility using an open reservoir oxygenator, over a time period of seven days. After obtaining 792 bacterial cultures from three sites within the ECC, the study was terminated. There were no positive bacterial cultures during the study period. Assuming there is no deliberate contamination, pump circuits assembled in an unused operating room can be maintained sterile for a period of seven days.