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Biomedical subjects

L M Campbell

Publications and source records attributed to L M Campbell.

At least 19 recordsLinked to original sources
PubMed2000

Candesartan cilexetil is not associated with cough in hypertensive patients with enalapril-induced cough. Multicentre Cough Study Group.

The aim of this study was to evaluate the occurrence of dry cough during treatment with candesartan cilexetil, enalapril, or placebo in patients with hypertension and a history of angiotensin converting enzyme (ACE)-inhibitor-related cough. Patients with confirmed cough during an enalapril (10 mg) challenge period, followed by no cough during a placebo dechallenge period were randomized to 8 weeks of double-blind treatment with candesartan cilexetil (8 mg) (n = 62), enalapril (10 mg) (n = 66), or placebo (n = 26). Incidence and severity of dry cough was evaluated by the symptom assessment questionnaire, frequency of dry cough by a visual analog scale, and the possible impact on quality of life by the minor symptom evaluation (MSE) profile. The percentage of patients with cough was significantly lower with candesartan cilexetil (35.5%) than with enalapril (68.2%, P < .001), and did not differ between candesartan cilexetil and placebo (26.9%, P > .20). Patients coughed less frequently and with less severe cough with candesartan cilexetil than with enalapril, and similarly with candesartan cilexetil and placebo. Changes in the MSE profile were minor, although candesartan cilexetil had better scores for contentment than placebo (P = .03), and also tended to be associated with better sleep than enalapril (P = .08). In hypertensive patients with ACE-inhibitor-induced cough, the incidence, frequency, and severity of dry cough was significantly lower with candesartan cilexetil than with enalapril, and no different from that found with placebo.

Adult↗
PubMed1999

Once-daily inhaled corticosteroids in mild to moderate asthma: improving acceptance of treatment.

Despite the established efficacy of inhaled corticosteroids in improving lung function in asthma, there has not been a corresponding improvement in morbidity and mortality associated with the disease, which, in part, may result from non-compliance with the prescribed regimen. The reasons for this are many and varied, but an important measure in improving the level of compliance in asthma patients is simplification of the treatment regimen, which may be achieved by reducing the dose frequency and improving the ease of administration. In clinical trials designed to determine whether a reduction in dose frequency to once daily is associated with similar efficacy to that with more frequent administration, a number of studies have shown that once-daily administration of inhaled corticosteroids in both adults and children is as effective in controlling asthma as twice-daily administration of the same dosage, both when given as initial therapy in corticosteroid-naïve patients and in patients already receiving an inhaled corticosteroid. The drug for which most evidence to support a dosage change from twice-daily to once-daily therapy currently exists is budesonide, though limited evidence with other inhaled corticosteroids such as beclomethasone dipropionate, fluticasone propionate and flunisolide also supports once-daily use. Despite the larger single dosage with once-daily budesonide therapy, there has been no evidence in clinical trials of a greater incidence of local adverse effects such as hoarseness, throat irritation or oropharyngeal candidosis, and no evidence of adrenal suppression or growth retardation. Since compliance is an important factor that can affect the success or failure of asthma therapy, a reduction in the frequency of administration to once daily offers the potential advantage of improved compliance with treatment and hence better control of asthma. In the short term clinical trials conducted to date, patient preferences have favoured the once-daily regimen over twice-daily administration. When combined with other (e.g. educational) measures to improve patient compliance, a switch from twice-daily (or more frequent) administration to once-daily inhaled corticosteroid therapy seems likely to be beneficial in improving the long term outcome of treatment.

Adrenal Cortex Hormones↗
PubMed1999

A comparison of the efficacy of long-acting beta 2-agonists: eformoterol via Turbohaler and salmeterol via pressurized metered dose inhaler or Accuhaler, in mild to moderate asthmatics. Force Research Group.

Four hundred and sixty nine patients were randomized to receive either 12 micrograms bd of eformoterol (Oxis, Astra Pharmaceuticals Ltd., Kings Langley, U.K.) delivered via Turbohaler or 50 micrograms bd salmeterol (Serevent, Glaxo-Wellcome Ltd., Uxbridge, U.K.) via either the Accuhaler (Glaxo-Wellcome Ltd.) or pressurized metered dose inhaler (pMDI, Glaxo-Wellcome Ltd.) for 8 weeks. This was followed by a 4-week cross-over period when patients who had received salmeterol in the previous 8 weeks were given eformoterol and patients who had received eformoterol were given either salmeterol via the Accuhaler or pMDI to assess patient device and treatment preference. For the primary efficacy variable, the increase in peak expiratory flow (PEF) rate from run-in to 8 weeks, similar significant improvements were seen in all three treatment groups. Eformoterol Turbohaler (FT) achieved a greater increase in morning PEF than salmeterol Accuhaler (SA) from randomisation to 4 weeks; the increase shown in the eformoterol Turbohaler group was 28.9 1 min-1 compared to 19.91 min-1 for the salmeterol Accuhaler group. The addition of eformoterol Turbohaler 12 micrograms bd, to patients' existing asthma therapy was found to have a significantly more beneficial effect on the severity of patients' daytime asthma symptoms than had salmeterol Accuhaler 50 micrograms bd (P = 0.014). Eformoterol Turbohaler reduced the severity of daytime asthma symptoms by 42% after only 4 weeks of treatment. The patients in the eformoterol Turbohaler treated group experienced a higher percentage of days when they were symptom-free and did not use their short-acting bronchodilator to relieve symptoms (32.8, 24.1 and 28.0% in the FT, SA and SM groups, respectively). At 8 weeks there were no significant differences in any of these variables between the three groups. Patients in all the treatment groups gained an additional 1-1.5 nights undisturbed by asthma per week. The changes in sleep disturbance were not significantly different between the three treatment groups. In addition to the therapeutic benefits provided by eformoterol Turbohaler the device (Turbohaler) was the significant preference of patients given both Turbohaler and pMDI (P = 0.0168) and was also considered to be significantly more convenient to carry around than the Accuhaler (P < 0.0001). No other differences were found between the three devices. The results of this study demonstrate that the addition of a long-acting beta 2-agonist is an effective tool for achieving the goals of asthma treatment. Eformoterol via the Turbohaler is at least as effective as salmeterol via either the Accuhaler or the pMDI in achieving these goals.

Adrenergic beta-Agonists↗
PubMed1999

A comparison of the efficacy of long-acting beta 2-agonists: eformoterol via Turbohaler and salmeterol via pressurized metered dose inhaler or Accuhaler, in mild to moderate asthmatics. Force Research Group.

Four hundred and sixty nine patients were randomized to receive either 12 micrograms bd of eformoterol (Oxis, Astra Pharmaceuticals Ltd., Kings Langley, U.K.) delivered via Turbohaler or 50 micrograms bd salmeterol (Serevent, Glaxo-Wellcome Ltd., Uxbridge, U.K.) via either the Accuhaler (Glaxo-Wellcome Ltd.) or pressurized metered dose inhaler (pMDI, Glaxo-Wellcome Ltd.) for 8 weeks. This was followed by a 4-week cross-over period when patients who had received salmeterol in the previous 8 weeks were given eformoterol and patients who had received eformoterol were given either salmeterol via the Accuhaler or pMDI to assess patient device and treatment preference. For the primary efficacy variable, the increase in peak expiratory flow (PEF) rate from run-in to 8 weeks, similar significant improvements were seen in all three treatment groups. Eformoterol Turbohaler (FT) achieved a greater increase in morning PEF than salmeterol Accuhaler (SA) from randomisation to 4 weeks; the increase shown in the eformoterol Turbohaler group was 28.9 l min-1 compared to 19.9 l min-1 for the salmeterol Accuhaler group. The addition of eformoterol Turbohaler 12 micrograms bd, to patients' existing asthma therapy was found to have a significantly more beneficial effect on the severity of patients' daytime asthma symptoms than had salmeterol Accuhaler 50 micrograms bd (P = 0.014). Eformoterol Turbohaler reduced the severity of daytime asthma symptoms by 42% after only 4 weeks of treatment. The patients in the eformoterol Turbohaler treated group experienced a higher percentage of days when they were symptom-free and did not use their short-acting bronchodilator to relieve symptoms (32.8, 24.1 and 28.0% in the FT, SA and SM groups, respectively). At 8 weeks there were no significant differences in any of these variables between the three groups. Patients in all the treatment groups gained an additional 1-1.5 nights undisturbed by asthma per week. The changes in sleep disturbance were not significantly different between the three treatment groups. In addition to the therapeutic benefits provided by eformoterol Turbohaler the device (Turbohaler) was the significant preference of patients given both Turbohaler and pMDI (P = 0.0168) and was also considered to be significantly more convenient to carry around than the Accuhaler (P < 0.0001). No other differences were found between the three devices. The results of this study demonstrate that the addition of a long-acting B2-agonist is an effective tool for achieving the goals of asthma treatment. Eformoterol via the Turbohaler is at least as effective as salmeterol via either the Accuhaler or the pMDI in achieving these goals.

Administration, Inhalation↗
PubMed1999

Clinical skills assessment.

BACKGROUND: From September 1996, all GP registrars completing vocational training in the United Kingdom must demonstrate competence by means of a four-part assessment procedure. AIM: To look at the accuracy of one of the components of vocational training: the trainer's report. METHOD: Seventy-five registrars completing their general practice training at the end of July 1997 were invited to take part in a practical skills workshop. Eight stations were designed to test practical skills and diagnostic interpretations that were included in the trainer's report, and a clinical vignette accompanied each task. The marking schedule used was developed from the minimum standards required in the trainer's report. Twenty-nine registrars (38%) took part in the workshop. RESULTS: Only one registrar passed all eight stations. The maximum number of stations failed by any one individual was five and this doctor was the only one of the sample to ultimately fail summative assessment. The majority of registrars failed by being unable to interpret clinical findings. Twenty-five registrars (86%) responded to the follow-up questionnaire. Of these, only six felt that the stations were unrealistic. All but two registrars had spent at least six months in their hospital training doing obstetrics and gynaecology but, in spite of this, only 31% of registrars were above minimum competence for vaginal and speculum examination. CONCLUSION: With one exception, registrars passed all aspects of the trainer's report. Discrepancy was found between the trainer's report and the doctor's ability to carry out clinical procedures. There is an assumption that many of these clinical skills are being taught and assessed at undergraduate level and during the hospital component, but this cannot be taken for granted. Doubt must also be cast on whether the trainers are using the trainer's report appropriately, and whether this is a valid and reliable tool to identify skills deficient in registrars for summative assessment.

Clinical Competence↗
PubMed1998

Adrenal hormone modulation of type 1 and type 2 cytokine production by spleen cells: dexamethasone and dehydroepiandrosterone suppress interleukin-2, interleukin-4, and interferon-gamma production in vitro.

Our previous work has documented that physical or psychological stress can alter interleukin (IL)-2, IL-4, and interferon (IFN)-gamma production by spleen or lymph node cells in vitro. To determine if adrenal hormones might be mediating these stress-induced changes in type 1 and type 2 cytokines and immune effector functions, we cultured spleen cells in vitro with either the synthetic glucocorticoid dexamethasone (DEX) or the putative restorative hormone dehydroepiandrosterone (DHEA). Spleen cells were obtained from either young (5-6 weeks old) or mature (7-8 months old) BALB/c mice that were either unimmunized or immunized with the T-cell-dependent antigen keyhole limpet hemocyanin (KLH). We determined that DEX suppressed production of all three cytokines examined. DHEA was not associated with any enhancement of cytokine production. These data challenge the hypothesis that glucocorticoids can differentially regulate Th1-like versus Th2-like cytokine production. Further, they suggest that in stress paradigms in which differential regulation of cytokine production and effector function has been observed, other neuroendocrine factors in addition to glucocorticoids must be relevant.

Animals↗
PubMed1998

Once-daily budesonide: 400 micrograms once daily is as effective as 200 micrograms twice daily in controlling childhood asthma. PETITE Research Group.

One hundred and sixty seven children on 0-200 microgram/day of inhaled steroid with asthma symptoms and sub-optimal peak flow values (less than 90% of that predicted for their height) were randomly allocated either 400 microgram once daily (nocte with placebo o.m.) or 200 mircrogram twice daily of budesonide Turbohaler for 8 weeks. Bronchdilator usage and symptoms were reduced in both groups at 4 and 8 weeks compared with baseline. There was a significant increase within both groups in morning and evening PEF after 4 and 8 weeks. The increase in evening PEF after 8 weeks was greater in the once-daily group than in the twice-daily group but there were no other significant differences between the groups (morning: +24.6 l/min vs 15.2 l/min, p = 0.059; evening: + 19.7 l/min vs +8.31 l/min; p = 0.013). Budesonide Turbohaler 400 microgram once daily is therefore as effective as 200 microgram twice daily in achieving asthma control in children.

Anti-Asthmatic Agents↗
PubMed1998

Initial loading (400 micrograms twice daily) versus static (400 micrograms nocte) dose budesonide for asthma management. PLAN Research Group.

This double-blind study aimed to determine whether superior asthma control is achieved with budesonide (Pulmicort Turbohaler) at a loading dose (LD) (400 micrograms b.d.) for 6 weeks, followed by step down to 400 micrograms nocte for 12 weeks, compared with a static dose (SD) (400 micrograms nocte) for 18 weeks. A total of 682 patients (mean peak expiratory flow rate (PEFR) 413 l/min), who demonstrated > or = 15% reversibility in PEFR, were randomised into the study. After 18 weeks, patients experienced improvements in morning PEFR (+45 l/min, both groups), symptom score (LD -0.57, SD -0.49, on a scale of 0-3), sleep disturbance (LD -1.21 nights/week, SD -1.06 nights/week) and beta 2-agonist use (LD -1.36 puffs/day, SD -1.06 puffs/day), within both groups (each p = 0.0001). At 18 weeks, 82% (LD) and 84% (SD) of patients benefited from no nocturnal wakening in the previous 7 days. Overall, at 18 weeks, asthma control was not significantly different between the groups. After 6 weeks, improvements in morning PEFR (LD +36 l/min, SD +26 l/min) and beta 2-agonist use (LD -1.10 puffs/day, SD -0.94 puffs/day) were greater in the loading dose than in the static dose group (each p < 0.05). The greater improvement in morning PEFR in the loading dose group was significant by day 7 (p < 0.05). While both regimens are equally effective in achieving asthma control at 18 weeks, early clinical advantage is gained with initial loading dose budesonide (400 micrograms b.d.).

Adult↗
PubMed1997

Efficacy and safety of atorvastatin compared to pravastatin in patients with hypercholesterolemia.

Plasma cholesterol and other lipoproteins play a significant role in the development of atherosclerosis and subsequent coronary heart disease (CHD). This 1 year study was designed to confirm the efficacy and safety of atorvastatin (Lipitor) compared to pravastatin, a marketed agent for low density lipoprotein cholesterol (LDL-C) reduction in hypercholesterolemic patients. Patients were recruited at 26 centers in six European countries. After a 6 week placebo baseline phase, patients were randomized to receive atorvastatin 10 mg or pravastatin 20 mg daily. The dose could be doubled at week 16, if LDL-C levels remained > or = 3.4 mmol/l (135 mg/dl). Atorvastatin significantly lowered LDL-C from baseline by 35% compared with 23% for pravastatin (P < 0.05). A total of 72% of atorvastatin patients attained the LDL-C target level of < 3.4 mmol/l, compared to 26% of pravastatin patients. Atorvastatin also significantly reduced TC, TG and apo B (P < 0.05). Safety was assessed by recording adverse events and measuring clinical laboratory parameters. The adverse event profile was similar for both treatment groups and neither treatment caused clinically relevant laboratory abnormalities. Atorvastatin 10 and 20 mg once daily is superior to pravastatin 20 and 40 mg once daily in treating patients with hypercholesterolemia.

Anticholesteremic Agents↗
PubMed1996

The effects of the introduction of a system of mandatory formative assessment for general practice trainees.

A series of questionnaires was used to determine the amount of formative assessment going on within the est of Scotland Region of the UK and its perceived value by trainees (General Practice [GP] Registrars) both at the beginning and end of training. The first survey was carried out in 1989 and the second in 1994. Trainers and course organizers were surveyed in 1994 to determine their attitudes to the use of videotaped consultations for formative assessment. In 1991, the region had initiated a mandatory formative assessment programme which included regular use of videotaped consultations, confidence rating scales and Manchester ratings (RCGP Occasional Paper Number 40). The use of a range of assessment methods for formative assessment of GP Registrars increased considerably between 1989 and 1994. The percentage of trainees using videotaped consultation analysis increased from 76 to 94%, for Manchester ratings from 52 to 68% and for confidence rating scales from 63 to 74%. Video and confidence scales were rated highly by trainees who were assessed by them and by most trainees at the start of the year, but less highly by those who had not been assessed by them by the end of the trainee year. Manchester ratings were not thought to be as useful, and for these there was no difference between users and non-users. Despite the mandatory system, a significant number of trainees (76%) were still not receiving the minimum assessment stipulated. Trainers rated lack of time as the main limiting factor to the greater use of video. We conclude that trainees who are exposed to assessment methods, particularly video, find it useful, but that some trainees are still receiving less than is optimal. We propose increased trainer education and intensified monitoring of the assessment carried out in training Practices.

Attitude↗
PubMed1996

A controlled assessment of an asthma self-management plan involving a budesonide dose regimen. OPTIONS Research Group.

Our aim was to assess the efficacy of budesonide (Pulmicort Turbohaler Astra) used as part of a self-management plan in a group of patients with chronic asthma. One hundred and twenty five patients with nocturnal asthma symptoms, despite the use of inhaled prophylactic and beta 2-agonist therapy, were randomized to inhaled budesonide 200, 400 or 800 micrograms b.i.d. either with dose adjustments made by the physician, i.e. doctor-managed (DM; n = 64), or as part of a self-management plan (SM; n = 61). The SM group were allowed to adjust their dose according to written guidelines based on morning peak flow. At the end of the 6 month treatment period, there were no significant differences detected between the DM and the SM groups either from the clinic or diary card data. Both groups demonstrated a significant reduction in the number of sleep-disturbed nights, by 75% in the DM group and 77% in the SM group, at the end of the study. In conclusion, for patients with mild-to-moderate asthma, either a doctor-adjusted dose regimen or a peak flow based self-management plan involving budesonide is equally efficacious. For some patients, a simple regimen, adjusted by the physician at clinic visits, may be easier to follow.

Administration, Inhalation↗
PubMed1996

Summative assessment of vocational trainees: results of a 3-year study.

BACKGROUND: Summative assessment of general practice trainees will be introduced across the UK for trainees completing vocational training after 1 September 1996. AIMS: A study was set up to assess the reliability of the consulting skills assessment which will be used to develop audit and factual knowledge testing as summative assessment tools and to determine the probable impact of the system on the numbers of trainees identified as not yet competent for independent practice. METHOD: Videotaped consultations, an audit project, a trainer's report and a multiple-choice paper were evaluated for 359 trainees in the West of Scotland completing their training between 31 July 1993 and 31 July 1995. RESULTS: A total of 77 trainees (22%) were identified as being potentially of doubtful competence and 17 (5%) were adjudged to be as yet incompetent for independent practice. Videotaped consultation produced the highest pickup rate (14) followed by trainer's judgement (3). Subsequent analysis of the video tapes identified one trainee who should have been picked up by this method but was not. CONCLUSION: The videotape instrument reliably identified the non-competent trainees. Audit and factual knowledge tests have a distinct role in summative assessment. The proportion of trainees being refused certificates by this assessment is likely to increase considerably but will still represent only about 5% of all trainees.

Education, Medical, Graduate↗
PubMed1996

Assessment of competence.

While it is essential that professional competence should be maintained, it is equally important that entry to the specialist ranks should be conditional on the demonstration of an acceptable level of competence. Multiple-choice papers and videotaped consultations are two parts of a multi-format approach to assessment which also includes a trainer's report and an audit report. The number of doctors identified as unsatisfactory at the recertification stage could be reduced by these methods, and the system could also provide a template for the introduction of recertification procedures.

Certification↗