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PubMed2006

Comparing pain control and ability to eat and drink with standard therapy vs Gelclair: a preliminary, double centre, randomised controlled trial on patients with radiotherapy-induced oral mucositis.

UNLABELLED: GOAL OF THE WORK: Oral mucositis (OM) is a functionally destructive complication of aggressive head and neck cancer therapy, often resulting in intense pain, an inability to eat and drink and secondary malnutrition and dehydration. The barrier-forming properties of Gelclair have shown promise in relieving such symptoms. The aim of this randomised-controlled trial was to evaluate the efficacy of Gelclair, as compared to standard therapy, as a means of short-term symptom control for patients suffering from radiotherapy-induced OM. MATERIALS AND METHODS: Twenty patients, with radiotherapy-induced OM seen in two oncology centres in Devon, were randomised to either standard therapy (Sucralfate and Mucaine) or Gelclair and assessed over 24 h. Both treatments were taken four times during the 24-h period, 30 min before meals. MAIN RESULTS: No significant difference was found between the Gelclair and standard therapy arms in terms of general pain (F = 1.512, df = 1, 17, ns). There did appear to be a trend towards pain improvement initially after the use of Gelclair, but this did not last for the full 24-h assessment period. There was no significant reduction in pain on speaking (F = 0.261, df = 1, 17, ns) nor an improvement in capacity to eat and drink, although the effects of standard therapy did appear to last longer than the Gelclair. CONCLUSION: This study indicates that Gelclair is no more effective than current standard practice in relieving the pain associated with radiotherapy-induced OM. Nevertheless, observations from this preliminary study warrant further investigation, with a view to shaping the way forward for head and neck cancer practice on a national level.

Adult↗

PubMed2005

A prospective randomised controlled trial of intermittent self-catheterisation vs. supra-pubic catheterisation for post-operative bladder care following radical hysterectomy.

OBJECTIVE: To determine the potential benefits of ISC (intermittent self-catheterisation) over SPC (supra-pubic catheterisation) in the post-operative bladder care of women following radical hysterectomy. METHODS: A prospective randomised controlled trial of women treated by radical hysterectomy for early stage cervical cancer. RESULTS.: 40 women were recruited to the study, 21 to ISC and 19 to SPC. All patients randomised to ISC were able to learn the technique of ISC satisfactorily following a period of pre-operative training. The day 3 and day 5 positive CSU (catheter specimen of urine) rate was significantly higher in the ISC group (42% and 63%) compared to the SPC group (6% and 18%), P = 0.05 and P = 0.004, respectively). Eight of 17 patients randomised to SPC (47%) documented having symptoms/problems arising from the SPC site of which 4 (23%) were shown to have a positive wound swab. There was no significant difference in length of period for bladder care between the two groups, P = 0.83. However, there were significant differences in patient acceptability (P = 0.009), freedom to lead a normal life (P = 0.000), disturbance at night (P = 0.006) and patient anxiety/embarrassment (P = 0.005) between the two groups. CONCLUSIONS: Patients are able to learn the technique of ISC without difficulty. Despite a greater urinary tract infection rate, the high incidence of SPC site problems can be avoided by use of ISC. The technique of ISC was seen to be more acceptable to patients allowing fewer disturbances at night, greater freedom to lead a normal life during the day and less anxiety/embarrassment compared to SPC.

Adult↗

PubMed1996

Randomised controlled trial of conservation therapy for breast cancer: 6-year analysis of the Scottish trial. Scottish Cancer Trials Breast Group.

BACKGROUND: To determine whether, when primary breast cancer is treated by local excision supported by systemic therapy appropriate to the oestrogen receptor status (ER) of the tumour, local radiotherapy can be avoided. METHODS: We carried out a randomised controlled trial in 585 patients aged less than 70 years with primary breast cancers of 4 cm or less in size in four specialist units and seven other hospitals in Scotland. After local excision of the tumour (1 cm margin) and an axillary lymph-node clearance or sample, all patients received systemic therapy with oral tamoxifen 20 mg daily or six 3-weekly intravenous bolus injections of cyclophosphamide 600 mg, methotrexate 50 mg, and fluorouracil 600 mg per m2, depending upon the ER concentration in the primary tumour. Patients were then randomly allocated to postoperative radical radiotherapy (50 Gy to breast with boost to the tumour bed) or to no further local treatment. The median follow-up of living patients was 5.7 years. The primary analysis was by intention to treat but since some patients did not receive systemic therapy appropriate to their ER status, a subsidiary analysis was restricted to 464 patients in whom all details of the protocol had been observed. FINDINGS: In the primary analysis survival was equal in the radiotherapy and non-radiotherapy groups (hazard ratio [HR] 0.98, 95% CI 0.67-1.44). Event-free survival showed an advantage in the irradiated patients (HR 0.54, 95% CI 0.39-0.74), largely due to fewer loco-regional relapses (HR 0.20, 95% CI 0.12-0.33). The relapse rate in the ipsilateral breast was 24.5% in the non-irradiated group and 5.8% following breast irradiation. The subsidiary analysis confirmed these findings and indicated the advantage of radiotherapy irrespective of ER concentration. There was a non-significant trend towards fewer distant metastases in the irradiated group. INTERPRETATION: After local excision of a primary breast cancer, we conclude that radiotherapy to the residual breast tissue is advisable even when selective adjuvant systemic therapy is given.

Adult↗

PubMed1997

Does routine follow up after head injury help? A randomised controlled trial.

OBJECTIVE: To evaluate the Medical Disability Society's 1988 recommendation that "every patient attending hospital after a head injury should be registered and offered an outpatient follow up appointment" by determining whether offering a routine follow up service to patients presenting to hospital with a head injury of any severity affects outcome six months later. DESIGN: A randomised controlled trial design with masked assessment of outcome. SETTING: A mixed rural and urban health district with a population of about 560000. PATIENTS: 1156 consecutive patients resident in Oxfordshire aged between 16 and 65 years presenting over 13 months to accident and emergency departments or admitted to hospital and diagnosed as having a head injury of any severity, including those with other injuries. INTERVENTIONS: Patients were registered and randomised to one of two groups. Both groups continued to receive the standard service offered by the hospitals. The early follow up group were approached at 7-10 days after injury and offered additional information, advice, support, and further intervention as needed. All randomised patients were approached for follow up assessment six months after injury by independent clinicians blind to their group. MAIN OUTCOME MEASURES: Validated questionnaires were used to elicit ratings of post-concussion symptoms (the Rivermead postconcussion symptoms questionnaire), and changes in work, relationships, leisure, social, and domestic activities (the Rivermead head injury follow up questionnaire). RESULTS: The two groups were comparable at randomisation. Data was obtained at six months on 226 of 577 "control" patients and 252 of 579 "trial" patients (59% were lost to follow up). There were no significant differences overall between the trial and control groups at follow up, but subgroup analysis of the patients with moderate or severe head injuries (posttraumatic amnesia > or = one hour, or admitted to hospital), showed that those in the early intervention group had significantly fewer difficulties with everyday activities (P = 0.03). CONCLUSIONS: The results from the 41% of patients followed up do not support the recommendation of offering a routine follow up to all patients with head injury, but they do suggest that routine follow up is most likely to be beneficial to patients with moderate or severe head injuries. Some of those with less severe injuries do continue to experience difficulties and need access to services. A further trial is under way to test these conclusions.

Adaptation, Psychological↗

PubMedDate not supplied

Antiviral medications to prevent cytomegalovirus disease and early death in recipients of solid-organ transplants: a systematic review of randomised controlled trials.

BACKGROUND: Antiviral prophylaxis is commonly used in recipients of solid-organ transplants with the aim of preventing the clinical syndrome associated with cytomegalovirus infection. We undertook a systematic review to investigate whether this approach affects risks of cytomegalovirus disease and death. METHODS: Randomised controlled trials of prophylaxis with antiviral medications for cytomegalovirus disease in solid-organ-transplant recipients were identified. Data were combined in meta-analyses by a random-effects model. FINDINGS: Compared with placebo or no treatment, prophylaxis with aciclovir, ganciclovir, or valaciclovir significantly reduced the risks of cytomegalovirus disease (19 trials, 1981 patients; relative risk 0.42 [95% CI 0.34-0.52]), cytomegalovirus infection (17 trials, 1786 patients; 0.61 [0.48-0.77]), and all-cause mortality (17 trials, 1838 patients; 0.63 [0.43-0.92]), mainly owing to lower mortality from cytomegalovirus disease (seven trials, 1300 patients; 0.26 [0.08-0.78]). Prophylaxis also lowered the risks of disease caused by herpes simplex or zoster virus, bacterial infections, and protozoal infections, but not fungal infection, acute rejection, or graft loss. Meta-regression showed no significant difference in the risk of cytomegalovirus disease or all-cause mortality by organ transplanted or cytomegalovirus serostatus; no conclusions were possible for cytomegalovirus-negative recipients of negative organs. In trials of direct comparisons, ganciclovir was more effective than aciclovir in preventing cytomegalovirus disease. Valganciclovir and intravenous ganciclovir were as effective as oral ganciclovir. INTERPRETATION: Prophylaxis with antiviral medications reduces the risk of cytomegalovirus disease and associated mortality in recipients of solid-organ transplants. This approach should be used routinely in cytomegalovirus-positive recipients and in cytomegalovirus-negative recipients of organs positive for the virus.

Acyclovir↗

PubMed1996

Randomised controlled trial of faecal-occult-blood screening for colorectal cancer.

BACKGROUND: There is growing evidence that faecal-occult-blood (FOB) screening may reduce colorectal cancer (CRC) mortality, but this reduction in CRC mortality has not been shown in an unselected population-based randomised controlled trial. The aim of this study was to assess the effect of FOB screening on CRC mortality in such a setting. METHODS: Between February, 1981, and January, 1991, 152,850 people aged 45-74 years who lived in the Nottingham area of the UK were recruited to our study. Participants were randomly allocated FOB screening (76,466) or no screening (controls; 76,384). Controls were not told about the study and received no intervention. Screening-group participants were sent a Haemoccult FOB test kit with instructions from their family doctor. FOB tests were not rehydrated and dietary restrictions were imposed only for retesting borderline results. Individuals with negative FOB tests at the first screening, together with those who tested positive but in whom no neoplasia was found on colonoscopy, were invited to take part in further screening every 2 years. Screening was stopped in February, 1995, by which time screening-group participants had been offered FOB tests between three and six times. Screening-group participants who had a positive test were offered full colonoscopy. All participants were followed up until June, 1995. The primary outcome measure was CRC mortality. FINDINGS: Of the 152,850 individuals recruited to the study, 2599 could not be traced or had emigrated and were excluded from the analysis. Thus, there were 75,253 participants in the screening group and 74,998 controls. 44,838 (59.6%) screening-group participants completed at least one screening. 28,720 (38.2%) of these individuals completed all the FOB tests they were offered and 16,118 (21.4%) completed at least one screening but not all the tests they were offered. 30,415 (40.4%) did not complete any test. Of 893 cancers (20% stage A) diagnosed in screening-group participants (CRC incidence of 1.49 per 1000 person-years), 236 (26.4%) were detected by FOB screening, 249 (27.9%) presented after a negative FOB test or investigation, and 400 (44.8%) presented in non-responders. The incidence of cancer in the control group (856 cases, 11% stage A) was 1.44 per 1000 person-years. Median follow-up was 7.8 years (range 4.5-14.5). 360 people died from CRC in the screening group compared with 420 in the control group-a 15% reduction in cumulative CRC mortality in the screening group (odds ratio=0.85 [95%; CI 0.74-0.98], p = 0.026). INTERPRETATION: Our findings together with evidence from other trials suggest that consideration should be given to a national programme of FOB screening to reduce CRC mortality in the general population.

Adenoma↗

PubMed2004

The 30 degree tilt position vs the 90 degree lateral and supine positions in reducing the incidence of non-blanching erythema in a hospital inpatient population: a randomised controlled trial.

Manual repositioning of patients by nursing staff is a recognised technique for preventing pressure ulcer formation. The 30 degree tilt is a method of positioning patients that, in the laboratory setting, reduced the contact pressure between the patient and the support surface. A randomised controlled trial was used to examine the effects of the 30 degree tilt position in reducing the incidence of non-blanching erythema (i.e. established pressure damage) in a hospital inpatient population (n=23) when compared to the use of the 90 degree lateral and supine position (n=23). The primary outcome of the trial was the incidence of pressure damage, defined as non-blanching erythema. In this study no subject developed pressure damage that presented with visible breaks in the epidermis, but all damage was restricted to areas of non-blanching erythema (five of the 39 subjects who completed the study exhibited such injury). The main findings of this study were that patient positioning using the 30 degree tilt method did not reduce the incidence of pressure damage compared with either the 90 degree lateral or supine positions. This study also investigated the feasibility of using the 30 degree tilt position with medical inpatients; it found that 78% of subjects experienced difficulty in adopting and maintaining the position. This finding seriously questions the practicality of using the 30 degree tilt method with a predominantly ill population.

Aged↗

PubMed2002

The effects of lavender (Lavendula angustifolium) baths on psychological well-being: two exploratory randomised control trials.

OBJECTIVE: Two important aspects of psychological well-being are positive mood state and a positive outlook with respect to the future. This study investigates the use of lavender baths to improve these aspects of psychological well-being. DESIGN: A single blind, randomised control trial. SETTING: The participants' home and interview rooms at the University of Wolverhampton. PARTICIPANTS: Eighty women not receiving treatment for psychological disorders who were staff or students at the University of Wolverhampton. Forty participated in Study 1 and 40 in Study 2. INTERVENTION: Participants were randomly allocated to use either grapeseed oil or 80% grapeseed oil and 20% lavender oil in their bath for 14 days. MAIN OUTCOME MEASURES: In Study 1, the UWIST mood adjective checklist. In Study 2, the MacLeod and Byrne Future Events procedure. RESULTS: In Study 1 psychologically positive mood changes were found after the bathing regimen for energetic arousal, tense arousal, hedonic tone and anger-frustration. Only anger-frustration showed a selective effect for lavender oil. In the second study negative responses about the future were selectively reduced after lavender oil baths. CONCLUSIONS: These results are encouraging and suggest further investigation using potential patients may result in the development of a useful procedure for improving psychological well-being.

Adult↗

PubMed2006

Effects of non-invasive ventilation on survival and quality of life in patients with amyotrophic lateral sclerosis: a randomised controlled trial.

BACKGROUND: Few patients with amyotrophic lateral sclerosis currently receive non-invasive ventilation (NIV), reflecting clinical uncertainty about the role of this intervention. We aimed to assess the effect of NIV on quality of life and survival in amyotrophic lateral sclerosis in a randomised controlled trial. METHODS: 92 of 102 eligible patients participated. They were assessed every 2 months and randomly assigned to NIV (n=22) or standard care (n=19) when they developed either orthopnoea with maximum inspiratory pressure less than 60% of that predicted or symptomatic hypercapnia. Primary validated quality-of-life outcome measures were the short form 36 mental component summary (MCS) and the sleep apnoea quality-of-life index symptoms domain (sym). Both time maintained above 75% of baseline (T(i)MCS and T(i)sym) and mean improvement (microMCS and microsym) were measured. FINDINGS: NIV improved T(i)MCS, T(i)sym, microMCS, microsym, and survival in all patients and in the subgroup with better bulbar function (n=20). This subgroup showed improvement in several measures of quality of life and a median survival benefit of 205 days (p=0.006) with maintained quality of life for most of this period. NIV improved some quality-of-life indices in those with poor bulbar function, including microsym (p=0.018), but conferred no survival benefit. INTERPRETATION: In patients with amyotrophic lateral sclerosis without severe bulbar dysfunction, NIV improves survival with maintenance of, and improvement in, quality of life. The survival benefit from NIV in this group is much greater than that from currently available neuroprotective therapy. In patients with severe bulbar impairment, NIV improves sleep-related symptoms, but is unlikely to confer a large survival advantage.

Aged↗

PubMed1989

Using nurses for preventive activities with computer assisted follow up: a randomised controlled trial.

OBJECTIVE: To assess whether an organised programme of prevention including the use of a health promotion nurse noticeably improved recording and follow up of cardiovascular risk factors and cervical smears in a general practice that had access to computerised cell and recall. DESIGN: Randomised controlled trial. SETTING: General practice in inner London. PATIENTS: All 3206 men and women aged 30-64 registered with the practice. INTERVENTION: The intervention group had their risk factors ascertained and followed up by the health promotion nurse and the general practitioner, whereas those in the control group were managed by the general practitioner alone. END POINT: Recording and follow up of blood pressure and cervical smears after three years. Recording of smoking, family history of ischaemic heart disease, and serum cholesterol concentrations were also examined. MEASUREMENTS AND MAIN RESULTS: When the trial was stopped after two years the measurements of blood pressure in the preceding five years were 93% (1511/1620) v 73% (1160/1586) (95% confidence interval for difference 17.5 to 22.7%) for intervention and control groups respectively. For patients with hypertension the figures were 97% (104/107) v 69% (80/116) (18.2 to 38.2%). For women the proportion who had had a cervical smear in the preceding three years were 76% (606/799) v 49% (392/806) (22.5 to 31.9%). Recording of smoking, family history of ischaemic heart disease, and serum cholesterol concentrations was also higher in the intervention group compared with the control group. CONCLUSION: An organised programme, which includes a nurse with specific responsibility for adult prevention, is likely to make an important contribution to recording of risk factors and follow up of those patients with known risks.

Adult↗

PubMed1989

Prospective randomised controlled trial of methods of call and recall for cervical cytology screening.

OBJECTIVE: To discover whether systematic methods of call and recall are more effective than a non-systematic method and to see which of the two systematic methods was more effective. DESIGN: Prospective randomised controlled trial over a year. SETTING: One group general practice. PATIENTS: 416 Women over 35 eligible for a smear test who had never had a cervical smear test or in whom a smear test was overdue (previous test more than five years before). INTERVENTIONS: One group received written invitations to have a smear taken. The second group had their notes tagged so that the doctor would remind them (when they attended for another reason) to have a smear test. No special intervention was made in the third group. MAIN OUTCOME MEASURE: Performance of a cervical smear test during the year of the study. RESULTS: 32% (45/140) of the screened group, 27% (39/142) of the tagged group, and 15% (20/134) of the control group had a smear test during the year. The percentage of women having a smear test in the screened group was not significantly different from that in the tagged group, but the percentages in the two groups were significantly different from that in the control group. Whether a woman had had a previous smear test significantly affected the uptake of the invitation to have a smear test independently of the method of invitation. CONCLUSIONS: The systematic methods of call and recall were more effective than a non-systematic method. There was no significant difference between the two systematic methods (sending letters or tagging the notes) at one year.

Adult↗

PubMed1996

Randomised controlled trial of effect of intervention by psychogeriatric team on depression in frail elderly people at home.

OBJECTIVE: To investigate the efficacy of intervention by a psychogeriatric team in the treatment of depression in elderly disabled people receiving home care from their local authority. DESIGN: Randomised controlled trial with blind follow up six months after recruitment. SETTING: Community of south east London. SUBJECTS: 69 people aged 65 or over who received home care and were depressed according to criteria of the standardised automatic geriatric examination for computer assisted taxonomy (AGECAT). 33 were randomly allocated to an intervention group and 36 to a control group. INTERVENTION: Members of the intervention group received an individual package of care that was formulated by the community psychogeriatric team in their catchment area and implemented by a researcher working as a member of that team. The control group received normal general practitioner care. MAIN OUTCOME MEASURES: Recovery from depression (AGECAT case at recruitment but non-case at follow up). RESULTS: Data were analysed on an intention to treat basis. 19 (58%) of the intervention group recovered compared with only nine (25%) of the control group, a difference of 33% (95% confidence interval 10% to 55%). This powerful treatment effect persisted after controlling for possible confounders in logistic regression analysis, with members of the intervention group more likely than members of the control group to have recovered at follow up (odds ratio 9.0 (2.0 to 41.5)). This did not seem to be a simple effect of antidepressant prescription: use of antidepressants at follow up did not have a significant effect (multiply adjusted odds ratio 0.3 (0.0 to 1.9)). CONCLUSIONS: Depression is treatable in elderly people receiving home care. Therapeutic nihilism based on an assumed poor response to treatment in these socially isolated, disabled elderly people in the community is not supported.

Aged↗

PubMed1997

Systematic review of randomised controlled trials of multiple risk factor interventions for preventing coronary heart disease.

OBJECTIVE: To assess the effectiveness of multiple risk factor intervention in reducing cardiovascular risk factors, total mortality, and mortality from coronary heart disease among adults. DESIGN: Systematic review and meta-analysis of randomised controlled trials in workforces and in primary care in which subjects were randomly allocated to more than one of six interventions (stopping smoking, exercise, dietary advice, weight control, antihypertensive drugs, and cholesterol lowering drugs) and followed up for at least six months. SUBJECTS: Adults aged 17-73 years, 903000 person years of observation were included in nine trials with clinical event outcomes and 303000 person years in five trials with risk factor outcomes alone. MAIN OUTCOME MEASURES: Changes in systolic and diastolic blood pressure, smoking rates, blood cholesterol concentrations, total mortality, and mortality from coronary heart disease. RESULTS: Net decreases in systolic and diastolic blood pressure, smoking prevalence, and blood cholesterol were 4.2 mm Hg (SE 0.19 mm Hg), 2.7 mm Hg (0.09 mm Hg), 4.2% (0.3%), and 0.14 mmol/l (0.01 mmol/l) respectively. In the nine trials with clinical event end points the pooled odds ratios for total and coronary heart disease mortality were 0.97 (95% confidence interval 0.92 to 1.02) and 0.96 (0.88 to 1.04) respectively. Statistical heterogeneity between the studies with respect to changes in mortality and risk factors was due to trials focusing on hypertensive participants and those using considerable amounts of drug treatment, with only these trials showing significant reductions in mortality. CONCLUSIONS: The pooled effects of multiple risk factor intervention on mortality were insignificant and a small, but potentially important, benefit of treatment (about a 10% reduction in mortality) may have been missed. Changes in risk factors were modest, were related to the amount of pharmacological treatment used, and in some cases may have been overestimated because of regression to the mean, lack of intention to treat analyses, habituation to blood pressure measurement, and use of self reports of smoking. Interventions using personal or family counselling and education with or without pharmacological treatments seem to be more effective at reducing risk factors and therefore mortality in high risk hypertensive populations. The evidence suggests that such interventions implemented through standard health education methods have limited use in the general population. Health protection through fiscal and legislative measure may be more effective.

Adolescent↗

PubMed1999

Single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women.

OBJECTIVE: To compare the effect of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment for genuine stress incontinence. DESIGN: Stratified, single blind, randomised controlled trial. SETTING: Multicentre. PARTICIPANTS: 107 women with clinically and urodynamically proved genuine stress incontinence. Mean (range) age was 49.5 (24-70) years, and mean (range) duration of symptoms 10.8 (1-45) years. INTERVENTIONS: Pelvic floor exercise (n=25) comprised 8-12 contractions 3 times a day and exercise in groups with skilled physical therapists once a week. The electrical stimulation group (n=25) used vaginal intermittent stimulation with the MS 106 Twin at 50 Hz 30 minutes a day. The vaginal cones group (n=27) used cones for 20 minutes a day. The untreated control group (n=30) was offered the use of a continence guard. Muscle strength was measured by vaginal squeeze pressure once a month. MAIN OUTCOME MEASURES: Pad test with standardised bladder volume, and self report of severity. RESULTS: Improvement in muscle strength was significantly greater (P=0.03) after pelvic floor exercises (11.0 cm H2O (95% confidence interval 7.7 to 14.3) before v 19.2 cm H2O (15.3 to 23.1) after) than either electrical stimulation (14.8 cm H2O (10. 9 to 18.7) v 18.6 cm H2O (13.3 to 23.9)) or vaginal cones (11.8 cm H2O (8.5 to 15.1) v 15.4 cm H2O (11.1 to 19.7)). Reduction in leakage on pad test was greater in the exercise group (-30.2 g; -43. 3 to 16.9) than in the electrical stimulation group (-7.4 g; -20.9 to 6.1) and the vaginal cones group (-14.7 g; -27.6 to -1.8). On completion of the trial one participant in the control group, 14 in the pelvic floor exercise group, three in the electrical stimulation group, and two in the vaginal cones group no longer considered themselves as having a problem. CONCLUSION: Training of the pelvic floor muscles is superior to electrical stimulation and vaginal cones in the treatment of genuine stress incontinence.

Adult↗

PubMed2005

Economic evaluation of nurse led intermediate care versus standard care for post-acute medical patients: cost minimisation analysis of data from a randomised controlled trial.

OBJECTIVE: To undertake an economic evaluation of nurse led intermediate care compared with standard hospital care for post-acute medical patients. DESIGN: Cost minimisation analysis from an NHS perspective, comprising secondary care, primary care, and community care, using data from a pragmatic randomised controlled trial. SETTING: Nurse led unit and acute general medical wards in large, urban, UK teaching hospital. PARTICIPANTS: 238 patients. OUTCOME MEASURE: Costs to acute hospital trusts and to the NHS over six months. RESULTS: On an intention to treat basis, nurse led care was associated with higher costs during the initial admission period (nurse led care 7892 pounds sterling (14,970 dollars; 11,503 euros), standard care 4810 pounds sterling, difference 3082 pounds sterling (95% confidence interval 1161 pounds sterling to 5002 pounds sterling)). During the readmission period, costs were similar (nurse led care 1444 pounds sterling, standard care 1879 pounds sterling, difference -435 pounds sterling, -1406 pounds sterling to 536 pounds sterling). Total costs at six months were significantly higher (nurse led care 10,529 pounds sterling , standard care 7819 pounds sterling, difference 2710 pounds sterling, 518 pounds sterling to 4903 pounds sterling). Sensitivity analyses suggested that the trend for nurse led care to be more expensive was maintained even with substantial cost reductions, although differences were no longer significant. CONCLUSION: Acute hospitals may not be cost effective settings for nurse led intermediate care. Both inpatient and total costs were significantly higher for nurse led care than for standard care of post-acute medical patients, suggesting that this model of care should not be pursued unless clinical or organisational benefits justify the increased investment.

Acute Disease↗

PubMed2001

A randomised controlled trial to compare methods of milk expression after preterm delivery.

OBJECTIVES: Primary: to compare sequential and simultaneous breast pumping on volume of milk expressed and its fat content. Secondary: to measure the effect of breast massage on milk volume and fat content. DESIGN: Sequential randomised controlled trial. SETTING: Neonatal intensive care unit, North Staffordshire Hospital NHS Trust. SUBJECTS: Data on 36 women were analysed; 19 women used simultaneous pumping and 17 used sequential pumping. INTERVENTIONS: Women were randomly allocated to use either simultaneous (both breasts simultaneously) or sequential (one breast then the other) milk expression. Stratification was used to ensure that the groups were balanced for parity and gestation. A crossover design was used for massage, with patients acting as their own controls. Women were randomly allocated to receive either massage or non-massage first. MAIN OUTCOME MEASURES: Volume of milk expressed per expression and its fat content (estimated by the creamatocrit method). RESULTS: Milk yield per expression was: sequential pumping with no massage, 51.32 g (95% confidence interval (CI) 56.57 to 46.07); sequential pumping with massage, 78.71 g (95% CI 85.19 to 72.24); simultaneous pumping with no massage, 87.69 g (95% CI 96.80 to 78.57); simultaneous pumping with massage, 125.08 g (95% CI 140.43 to 109.74). The fat concentration in the milk was not affected by the increase in volume achieved by the interventions. CONCLUSIONS: The results are unequivocal and show that simultaneous pumping is more effective at producing milk than sequential pumping and that breast massage has an additive effect, improving milk production in both groups. As frequent and efficient milk removal is essential for continued production of milk, mothers of preterm infants wishing to express milk for their sick babies should be taught these techniques.

Cross-Over Studies↗

PubMed2001

A randomised controlled trial of the effectiveness of combining video role play with traditional methods of delivering undergraduate medical education.

OBJECTIVE: To determine the effectiveness of video role play with structured feedback in improving undergraduate communication skills and application of knowledge in genitourinary medicine. DESIGN: A blind, randomised, controlled trial. SUBJECTS AND SETTING: Fourth year undergraduates attending a 5 week attachment in genitourinary medicine during 1997 at a London medical school. INTERVENTION: A randomly selected sample group of undergraduates were filmed in the role of a doctor interviewing a patient (played by an actor) presenting with a genitourinary (GU) problem. Structured feedback by a GU physician and an educational psychologist was given a week later. The control group of undergraduates did not receive this training intervention. OUTCOME MEASURES: Student performance in two stations of an objective structured clinical examination (OSCE), administered at the end of their attachment. This tested communication skills and knowledge in GU settings. RESULTS: 132 undergraduates were assessed in the OSCE. 40 of these were in the sample group who received training using video role play with feedback and 92 were in the control group. The sample group scored significantly higher marks than the control group (p<0.001). CONCLUSIONS: Video role play with structured feedback is effective in improving undergraduate communication skills and application of knowledge in GU medicine settings.

Education, Medical, Undergraduate↗

PubMed2004

Effect of a medication management training package for nurses on clinical outcomes for patients with schizophrenia: cluster randomised controlled trial.

BACKGROUND: Non-compliance attenuates the efficacy of treatments for physical and mental disorders. AIMS: To assess the effectiveness of a medication management training package for community mental health nurses (CMHNs) in improving compliance and clinical outcomes in patients with schizophrenia. METHOD: Pragmatic randomised controlled trial. Sixty CMHNs in geographical clusters were assigned randomly to medication management training or treatment as usual. Each CMHN identified two patients on their case-load who were assessed at baseline and again after 6 months by a research worker. The primary efficacy outcome of interest was psychopathology, measured using the Positive and Negative Syndrome Scale (PANSS). RESULTS: Nurses who had received medication management training produced a significantly greater reduction in patients'overall psychopathology compared with treatment as usual at the end of the 6-month study period (change in PANSS total scores: medication management -16.62, treatment as usual 1.17; difference -17.79; 95% CI -24.12 to -11.45; P<0.001). CONCLUSIONS: Medication management training for CMHNs is effective in improving clinical outcomes in patients with schizophrenia.

Adult↗