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Results for “Randomised Controlled Trial”

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PubMed2004

A double-blind randomised controlled trial of laparoscopic uterine nerve ablation for women with chronic pelvic pain.

OBJECTIVE: To determine the effectiveness of laparoscopic uterine nerve ablation (LUNA) for chronic pelvic pain in women with endometriosis and women with no laparoscopic evidence of endometriosis. DESIGN: A prospective double-blind randomised controlled trial (RCT). SETTING: Single-centre, secondary-level gynaecology outpatient service and tertiary-level pelvic pain and endometriosis outpatient service in Auckland, New Zealand. POPULATION: One hundred and twenty-three women undergoing laparoscopy for investigation and management of chronic pelvic pain, 56 with no laparoscopic evidence of endometriosis and 67 with endometriosis. METHODS: Women were randomised from the two populations, firstly those with no evidence of endometriosis and secondly those undergoing laparoscopic surgical treatment for endometriosis, to receive LUNA or no LUNA. Participant and assessor blinding was employed. Follow up for pain outcomes was undertaken at 24 hours, 3 months and 12 months. MAIN OUTCOME MEASURES: Changes in non-menstrual pelvic pain, dysmenorrhoea, deep dyspareunia and dyschezia were assessed primarily by whether there was a decrease in visual analogue score for these types of pain of 50% or more from baseline and additionally whether there was a significantly different change in median visual analogue score. The numbers requiring further surgery or starting a new medical treatment for pelvic pain and complications were also measured. RESULTS: There was a significant reduction in dysmenorrhoea at 12 month follow up in women with chronic pelvic pain in the absence of endometriosis who underwent LUNA (median change in visual analogue scale (VAS) from baseline -4.8 versus-0.8 (P= 0.039), 42.1%versus 14.3% experiencing a successful treatment defined as a 50% or greater reduction in visual analogue pain scale for dysmenorrhoea (P= 0.045). There was no significant difference in non-menstrual pelvic pain, deep dyspareunia or dyschezia in women with no endometriosis undergoing LUNA versus no LUNA. The addition of LUNA to laparoscopic surgical treatment of endometriosis was not associated with a significant difference in any pain outcomes. CONCLUSIONS: LUNA is effective for dysmenorrhoea in the absence of endometriosis, although there is no evidence of effectiveness of LUNA for non-dysmenorrhoeic chronic pelvic pain or for any type of chronic pelvic pain related to endometriosis.

Adolescent↗

PubMed2006

A randomised controlled trial comparing computer-assisted with face-to-face sexual history taking in a clinical setting.

AIM: To compare computer-assisted self-interview (CASI) with routine face-to-face interview (FTFI) for sexual history taking from patients in a clinical setting. METHODS: A randomised controlled trial was undertaken at the Melbourne Sexual Health Centre, Melbourne, Victoria, Australia, in 2005. New, walk-in patients triaged into the centre were eligible for the study. Those who consented to the study were randomly allocated (initially at a ratio of 2:1, then 1:1) to either CASI or FTFI. Those randomised to CASI also subsequently undertook FTFI. RESULTS: During the study period, of 713 patients approached, 611 agreed to participate in the study; 356 were randomised to FTFI and 255 to CASI. Overall, the responses to questioning using CASI and FTFI were similar except that women undertaking the CASI reported a significantly higher median number of male partners for the preceding 12 months (3 v 2, p = 0.05) and the CASI participants reported previous hepatitis B vaccination more often (50% v 37%, p = 0.01). Most participants found the CASI either easy (31; 13%) or very easy (193; 82%) to complete; 83 (35%) were comfortable and 121 (51%) were very comfortable with it. CONCLUSIONS: CASI may be a reliable, efficient and highly acceptable method for the screening of sexual risk in clinical sexual health settings and could be used routinely to improve the efficiency of clinical services.

Adult↗

PubMed2007

Buprenorphine versus dihydrocodeine for opiate detoxification in primary care: a randomised controlled trial.

BACKGROUND: Many drug users present to primary care requesting detoxification from illicit opiates. There are a number of detoxification agents but no recommended drug of choice. The purpose of this study is to compare buprenorphine with dihydrocodeine for detoxification from illicit opiates in primary care. METHODS: Open label randomised controlled trial in NHS Primary Care (General Practices), Leeds, UK. Sixty consenting adults using illicit opiates received either daily sublingual buprenorphine or daily oral dihydrocodeine. Reducing regimens for both interventions were at the discretion of prescribing doctor within a standard regimen of not more than 15 days. Primary outcome was abstinence from illicit opiates at final prescription as indicated by a urine sample. Secondary outcomes during detoxification period and at three and six months post detoxification were recorded. RESULTS: Only 23% completed the prescribed course of detoxification medication and gave a urine sample on collection of their final prescription. Risk of non-completion of detoxification was reduced if allocated buprenorphine (68% vs 88%, RR 0.58 CI 0.35-0.96, p = 0.065). A higher proportion of people allocated to buprenorphine provided a clean urine sample compared with those who received dihydrocodeine (21% vs 3%, RR 2.06 CI 1.33-3.21, p = 0.028). People allocated to buprenorphine had fewer visits to professional carers during detoxification and more were abstinent at three months (10 vs 4, RR 1.55 CI 0.96-2.52) and six months post detoxification (7 vs 3, RR 1.45 CI 0.84-2.49). CONCLUSION: Informative randomised trials evaluating routine care within the primary care setting are possible amongst drug using populations. This small study generates unique data on commonly used treatment regimens.

Adult↗

PubMed2001

Multicentre, randomised controlled trial of four-layer bandaging versus short-stretch bandaging in the treatment of venous leg ulcers.

BACKGROUND: Aim of the study was to compare the healing rates of venous ulcers obtained with four-layer bandages (4LB) versus short stretch bandages (SSB). DESIGN: Multicentre, randomised controlled trial performed in 5 centres of the Netherlands and in 2 centres in Austria ("PADS-study" = Profore Austrian Dutch Study). PATIENTS AND METHODS: 112 patients (53 treated with 4LB and 59 treated with SSB) completed at least one post-treatment follow-up, 90 completed the study. Bandaging and ulcer assessment was performed at weekly intervals. Randomisation was carried out for each centre and was stratified according to the size (more or less than 10 cm2) of the ulcerated area. Local therapy consisted of plain absorbing, non-adherent dressings. Time to complete healing was recorded up to a maximum of 16 weeks. The two treatment-groups were comparable regarding their baseline-characteristics. RESULTS: In total 33/53 (62%) of ulcer-patients were healed in the 4LB group, compared with 43/59 (73%) in the SSB group (difference 11%, 95% CI -28% to 7%). 77% of the ulcers with an initial area less than 5 cm2 healed as compared with 33% of the larger ulcers. The different healing rates in the centres could be explained by the different sizes of the treated ulcers. Based on Kaplan-Meier estimates the median healing time was 57 days for the 4LB (95% CI 47-85 days) and 63 days for the SSB (95% CI 43-70 days). CONCLUSION: The ulcer healing rate and the median healing time did not differ among the two types of bandages. The main discriminant criterion for healing was the initial ulcer size. In centres who are experienced users of short-stretch bandages, no statistically significant different healing rates of venous ulcers could be found after 4LB or SSB.

Adult↗

PubMed2005

Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care.

OBJECTIVE: To assess whether supplementation with calcium and cholecaliferol (vitamin D3) reduces the risk of fracture in women with one or more risk factors for fracture of the hip. DESIGN: Pragmatic open randomised controlled trial. SETTING: Practice nurse led clinics in primary care. PARTICIPANTS: 3314 women aged 70 and over with one or more risk factors for hip fracture: any previous fracture, low body weight (< 58 kg), smoker, family history of hip fracture, or fair or poor self reported health. INTERVENTION: Daily oral supplementation using 1000 mg calcium with 800 IU cholecaliferol and information leaflet on dietary calcium intake and prevention of falls, or leaflet only (control group). MAIN OUTCOME MEASURES: Primary outcome measure was all clinical fractures and secondary outcome measures were adherence to treatment, falls, and quality of life (measured with the SF-12). RESULTS: 69% of the women who completed the follow-up questionnaire at 24 months were still taking supplements (55% with inclusion of randomised participants known to be alive). After a median follow-up of 25 months (range 18 to 42 months), clinical fracture rates were lower than expected in both groups but did not significantly differ for all clinical fractures (odds ratio for fracture in supplemented group 1.01, 95% confidence interval 0.71 to 1.43). The odds ratio for hip fracture was 0.75 (0.31 to 1.78). The odds of a woman having a fall at six and 12 months was 0.99 and 0.98, respectively. Quality of life did not significantly differ between the groups. CONCLUSION: We found no evidence that calcium and vitamin D supplementation reduces the risk of clinical fractures in women with one or more risk factors for hip fracture. Registration ISRCTN26118436, controlled trials registry.

Administration, Oral↗

PubMed2004

EULAR randomised controlled trial of pulse cyclophosphamide and methylprednisolone versus continuous cyclophosphamide and prednisolone followed by azathioprine and prednisolone in lupus nephritis.

OBJECTIVE: To compare the efficacy and side effects of intermittent pulse cyclophosphamide plus methylprednisolone with continuous oral cyclophosphamide plus prednisolone, followed by azathioprine, in patients with proliferative glomerulonephritis caused by systemic lupus erythematosus (SLE). METHODS: A multicentre randomised controlled trial was conducted between June 1992 and May 1996 involving eight European centres. All patients satisfied the American College of Rheumatology criteria for SLE and had biopsy proven proliferative lupus nephritis. All received corticosteroids in addition to cytotoxic drugs, as defined in the protocol, for two years. The trial was terminated after four years as recruitment was disappointing. RESULTS: 32 SLE patients with lupus nephritis were recruited: 16 were randomised to intermittent pulse cyclophosphamide and 16 to continuous cyclophosphamide plus azathioprine. Mean duration of follow up was 3.7 years in the continuous group (range 0 to 5.6) and 3.3 years in the pulse group (range 0.25 to 6). Three patients were excluded from the pulse therapy group as they were later found to have pure mesangial glomerulonephritis. Two patients in the continuous therapy group developed end stage renal failure requiring dialysis, but none in the intermittent pulse therapy (p = 0.488; NS). There were similar numbers of side effects and withdrawals from treatment in both groups. There were three deaths: two in the intermittent pulse therapy group and one in the continuous therapy group. CONCLUSIONS: There was no statistically significant difference in efficacy and side effects between the two regimens. Infectious complications occurred commonly, so careful monitoring is required during treatment.

Administration, Oral↗

PubMed1993

Randomised controlled trial of plasma protein fraction versus dopamine in hypotensive very low birthweight infants.

Around 20% of very low birthweight infants admitted to a neonatal intensive care unit become hypotensive within 24 hours of their admission. Standard treatment is either expansion of the circulating volume by the infusion of plasma protein fraction or by using dopamine to improve cardiac function. The purpose of this study was to investigate by a randomised controlled trial which was the most appropriate treatment. Thirty nine infants were randomised to receive either plasma protein fraction or dopamine as first line treatment if they became hypotensive within 24 hours of admission to the neonatal intensive care unit. Seventeen of 19 (89%) infants responded to dopamine, whereas only 9/20 (45%) responded to plasma protein fraction. The median dose of dopamine needed to increase the blood pressure to at least the 10th centile was 7.5 micrograms/kg/min and was infused for a median duration of 18 hours. These observations suggest that dopamine should be used earlier in the treatment of these infants than has previously been recommended.

Blood Proteins↗

PubMed2006

Randomised controlled trial of a short course of traditional acupuncture compared with usual care for persistent non-specific low back pain.

OBJECTIVE: To determine whether a short course of traditional acupuncture improves longer term outcomes for patients with persistent non-specific low back pain in primary care. DESIGN: Pragmatic, open, randomised controlled trial. SETTING: Three private acupuncture clinics and 18 general practices in York, England. PARTICIPANTS: 241 adults aged 18-65 with non-specific low back pain of 4-52 weeks' duration. INTERVENTIONS: 10 individualised acupuncture treatments from one of six qualified acupuncturists (160 patients) or usual care only (81 patients). MAIN OUTCOME MEASURES: The primary outcome was SF-36 bodily pain, measured at 12 and 24 months. Other outcomes included reported use of analgesics, scores on the Oswestry pain disability index, safety, and patient satisfaction. RESULTS: 39 general practitioners referred 289 patients of whom 241 were randomised. At 12 months average SF-36 pain scores increased by 33.2 to 64.0 in the acupuncture group and by 27.9 to 58.3 in the control group. Adjusting for baseline score and for any clustering by acupuncturist, the estimated intervention effect was 5.6 points (95% confidence interval -0.2 to 11.4) at 12 months (n = 213) and 8.0 points (2.8 to 13.2) at 24 months (n = 182). The magnitude of the difference between the groups was about 10%-15% of the final pain score in the control group. Functional disability was not improved. No serious or life threatening events were reported. CONCLUSIONS: Weak evidence was found of an effect of acupuncture on persistent non-specific low back pain at 12 months, but stronger evidence of a small benefit at 24 months. Referral to a qualified traditional acupuncturist for a short course of treatment seems safe and acceptable to patients with low back pain. TRIAL REGISTRATION: ISRCTN80764175 [controlled-trials.com].

Acupuncture Therapy↗

PubMed1996

Randomised controlled trial of steroid withdrawal in renal transplant recipients receiving triple immunosuppression.

BACKGROUND: The combination of cyclosporin, azathioprine, and prednisolone (triple immunosuppression) is the most commonly used immunosuppressive regimen early after renal transplantation, but the risks and benefits of maintaining the steroid component of this regimen in the long term are uncertain. METHODS: A randomised controlled trial of steroid withdrawal was conducted among renal transplant patients receiving triple immunosuppression. Between one and six years after transplantation, 100 such patients were randomised either to reduce prednisolone treatment to zero over about four months or to maintain their triple immunosuppression unchanged. Outcome was analysed according to "Intention-to-treat". FINDINGS: In 42 (86%) of 49 patients allocated to steroid withdrawal, complete steroid withdrawal was achieved. Although these patients did not experience defined acute rejection episodes, insidious increases in plasma creatinine were observed more frequently in this group than in the controls. In 97 patients surviving one year after trial entry, plasma creatinine exceeded the baseline by more than 25% at some time in the first year in 25 (53%) of 47 in the steroid withdrawal group compared with 9 (18%) of 50 in the control group (p < 0.001, chi-square test). In some cases these increases were transient. However, when corrected for the baseline (entry) value significant differences between groups were apparent in both mean plasma creatinine and mean creatinine clearance; mean (SD) plasma creatinine values at entry, immediately after withdrawal, and at one year were 138 (27), 151 (36), and 150 (36) mumol/L in the steroid withdrawal group versus 138 (34), 140 (51), and 139 (47) mumol/L in the control group (p = 0.017, analysis of covariance). Steroid withdrawal patients showed a further rise in mean plasma creatinine to 160 (44) and 161 (65) mumol/L at two and three years from trial entry. Changes in several clinical and metabolic indices were also observed in association with steroid withdrawal. Blood pressure declined but the reduction was incompletely sustained, being more evident immediately after steroid withdrawal than at one year. Total cholesterol declined about 1 mmol/L in the steroid withdrawal group. Other changes associated with steroid withdrawal were reductions in white cell count and haemoglobin and increases in plasma phosphate and alkaline phosphatase. INTERPRETATION: Late steroid withdrawal is feasible in most patients with stable graft function on triple immunosuppression and has potentially beneficial metabolic effects. However, a substantial proportion of patients show a reduction in graft function, indicating a need for caution in considering the long term outcome.

Adult↗

PubMed2003

Specialist treatment versus self-help for bulimia nervosa: a randomised controlled trial in general practice.

BACKGROUND: Little is known about general practice management of patients with eating disorders. AIM: To compare the effectiveness of a general practice-based, self-help approach to the treatment of bulimia nervosa with that of specialist outpatient treatment. DESIGN OF STUDY: A prospective, parallel group, randomised controlled trial. SETTING: General practices and specialist eating disorder clinics in London. METHOD: Patients were recruited from general practitioner (GP) referrals to specialist eating disorder clinics. Thirty-four patients were randomised to receive the self-help intervention in general practice and thirty-four were randomised to the clinic intervention. Patients randomised to the self-help arm of the trial worked through a manual based on cognitive behaviour principles, while keeping in contact with their GPs. Those randomised to receive specialist treatment were managed in the specialist clinic to which they had been referred. The main outcome measure was the Bulimic Investigatory Test Edinburgh score, assessed at baseline and at six and nine months. Secondary measures were eating pathology, depression, and social adjustment. RESULTS: A total of 74% and 80% of patients were followed up at six and nine months respectively. An intention-to-treat analysis revealed that, while bulimic symptoms declined in both groups over time, there was no significant difference in outcome between the two groups. CONCLUSION: The findings lend support to the idea that patients with bulimia nervosa can be treated in general practice and that this approach warrants further investigation.

Adult↗

PubMed2006

A randomised controlled trial to determine the effectiveness of an early psychological intervention with children involved in road traffic accidents.

OBJECTIVE: To determine whether an early intervention using a psychological debriefing format is effective in preventing psychological distress in child road traffic accident survivors. DESIGN: Randomised controlled trial. SETTING: Accident and Emergency Department, Royal United Hospital, Bath. SUBJECTS: 158 children aged 7-18. Follow-up assessment completed eight months post accident with 132 (70/82 of the experimental group and 62/76 in the control group). MAIN OUTCOME MEASURES: Self-completed measures of psychological distress; fulfilment of diagnostic criteria for post-traumatic stress disorder. RESULTS: Children in both groups demonstrated considerable improvements at follow-up. The early intervention did not result in any additional significant gains. CONCLUSIONS: Although children in this study made significant improvements it is unclear whether these are better or worse than natural recovery rates. The specific intervention did not result in additional gains although the structured assessment provided for both groups may have been helpful in reducing subsequent pathology.

Accidents, Traffic↗

PubMed2006

A randomised control trial of clingfilm for prevention of hypothermia in term infants during phototherapy.

INTRODUCTION: This study aimed to compare the core, abdominal wall, and plantar temperatures of well jaundiced term infants undergoing phototherapy with or without clingfilm covering the lower two-thirds of the upper end of their bassinets. METHODS: This was a randomised controlled trial carried out in a tertiary university hospital on normal healthy term infants undergoing phototherapy. 106 eligible infants were randomised to receive phototherapy with (n=52) or without (n=54) the use of clingfilm during a two-hour period. Subsequently, after nappy change and feeding, they were crossed over to receive phototherapy without or with the clingfilm in place, respectively. Their body temperatures were measured at zero and two hours after phototherapy. RESULTS: There was no significant difference in their core, abdominal wall and plantar temperatures at baseline and after two hours of phototherapy (p-value is greater than 0.05) between infants with and without the use of clingfilm. Irrespective of the use of clingfilm, there was significant (p-value is less than 0.001) increase in core body temperatures after two hours of continuous phototherapy, with resultant hyperthermia (greater than 37.5 degree Celsius) in 42 percent of infants when under clingfilm and 35.8 percent when without clingfilm. A few (2.8 percent) infants, though statistically not significant, became mildly hypothermic after two hours of phototherapy when clingfilm was not used (p-value is greater than 0.05). CONCLUSION: Hyperthermia was common during phototherapy, irrespective of the use of clingfilm. Hypothermia was rare and the preventive role of clingfilm is not certain.

Body Temperature↗

PubMed2004

Effect of prize draw incentive on the response rate to a postal survey of obstetricians and gynaecologists: a randomised controlled trial. [ISRCTN32823119].

BACKGROUND: Response rates to postal questionnaires are falling and this threatens the external validity of survey findings. We wanted to establish whether the incentive of being entered into a prize draw to win a personal digital assistant (PDA) would increase the response rate for a national survey of consultant obstetricians and gynaecologists. METHODS: A randomised controlled trial was conducted. This involved sending a postal questionnaire to all Consultant Obstetricians and Gynaecologists in the United Kingdom. Recipients were randomised to receiving a questionnaire offering a prize draw incentive (on response) or no such incentive. RESULTS: The response rate for recipients offered the prize incentive was 64% (461/716) and 62% (429/694) in the no incentive group (relative rate of response 1.04, 95% CI 0.96 - 1.13) CONCLUSION: The offer of a prize draw incentive to win a PDA did not significantly increase response rates to a national questionnaire survey of consultant obstetricians and gynaecologists.

Computers, Handheld↗

PubMed2005

Cost-effectiveness of telephone or surgery asthma reviews: economic analysis of a randomised controlled trial.

BACKGROUND: Only about a third of people with asthma attend an annual review. Clinicians need to identify cost-effective ways to improve access and ensure regular review. AIM: To compare the cost-effectiveness of nurse-led telephone with face-to-face asthma reviews. DESIGN OF STUDY: Cost-effectiveness analysis based on a 3-month randomised controlled trial. SETTING: Four general practices in England. METHOD: Adults due an asthma review were randomised to telephone or face-to-face consultations. Trial nurses recorded proportion reviewed, duration of consultation, and abortive calls/missed appointments. Data on use of healthcare resources were extracted from GP records. Cost-effectiveness was assessed from the health service perspective; sensitivity analyses were based on proportion reviewed and duration of consultation. RESULTS: A total of 278 people with asthma were randomised to surgery (n = 141) or telephone (n = 137) review. Onehundred-and-one (74%) of those with asthma in the telephone group were reviewed versus 68 (48%) in the surgery group (P <0.001). Telephone consultations were significantly shorter (mean duration telephone = 11.19 minutes [standard deviation {SD} = 4.79] versus surgery = 21.87 minutes [SD = 6.85], P <0.001). Total respiratory healthcare costs per patient over 3 months were similar (telephone = pounds sterling 64.49 [SD = 73.33] versus surgery = pounds sterling 59.48 [SD = 66.02], P = 0.55). Total costs of providing 101 telephone versus 68 face-to-face asthma reviews were also similar (telephone = pounds sterling 725.84 versus surgery = pounds sterling 755.70), but mean cost per consultation achieved was lower in the telephone arm (telephone = pounds sterling 7.19 [SD = 2.49] versus surgery = pounds sterling 11.11 [SD = 3.50]; mean difference = - pounds sterling 3.92 [95% confidence interval = - pounds sterling 4.84 to pounds sterling 3.01], P <0.001). CONCLUSIONS: Telephone consultations enable a greater proportion of asthma patients to be reviewed at no additional cost to the health service. This mode of delivering care improves access and reduces cost per consultation achieved.

Asthma↗

PubMed2004

The use of oral misoprostol for pre-abortion cervical priming: a randomised controlled trial of 400 versus 200 microg in first trimester pregnancies.

OBJECTIVE: To compare the impact of 200 and 400 microg oral misoprostol on pre-operative cervical priming in both primi- and multigravidae prior to first trimester termination of pregnancy. Pre-operative cervical dilatation and bleeding were assessed. DESIGN: Randomised controlled trial. SETTING: Norwegian university teaching hospital. SAMPLE: Five hundred and fifty-one women undergoing surgical termination of pregnancy between 7 and 12 weeks of gestation. METHODS: Patients were randomised to either 200 or 400 microg of oral misoprostol 10-16 hours before vacuum aspiration. The degree of cervical dilatation prior to abortion by vacuum aspiration was measured. Pre-operative bleeding and pain were recorded and vaginal bleeding was measured. MAIN OUTCOME MEASURES: Degree of pre-operative cervical dilatation and pre-operative bleeding. RESULTS: The mean cervical dilatation was 5.8 mm (SD 1.7) for the women who received 400 microg misoprostol and 5.4 mm (SD 1.4) for those who received 200 microg (P= 0.004). The pre-operative dilatation was larger in multigravidae than in primigravidae in both dosage groups. The odds ratio (OR) of pre-operative bleeding was 3.3 (95% confidence interval [CI] 2.1-5.0) in the 400 microg dosage group, as compared with the group receiving 200 microg misoprostol. The occurrence of bleeding was dose-dependent. Frequency of bleeding was similar in multigravidae compared with primigravidae in the 400 microg dosage group, whereas the occurrence of bleeding was less in primigravidae than multigravidae in the 200 microg dosage group. Only 89 out of 551 patients bled one or more grams. The volumes measured were not statistically significantly different. Complications were minor, and were distributed equally between the two dosage groups. CONCLUSIONS: The 200 microg oral misoprostol compared with the 400 microg oral misoprostol given 10-16 hours before first trimester surgical abortions results in less pre-operative vaginal bleeding and in a statistically, although not clinically significant reduction in cervical dilatation.

Abortifacient Agents, Nonsteroidal↗

PubMed2006

A randomised control trial of patient self-management of oral anticoagulation compared with patient self-testing.

Several studies suggest that patient self-management (PSM) may improve the quality of oral anticoagulation therapy as measured by time spent within the international normalised ratio (INR) target range. We performed a prospective randomised control trial to determine whether the improvement in quality of treatment afforded by PSM is greater than that achieved by patient self-testing (PST) alone. A total of 104 of 800 eligible patients aged 22-88 years (median = 59.8), attending our hospital anticoagulant clinic and receiving long-term warfarin for >8 months agreed to participate. Patients were randomised to PSM (n = 55) or PST (n = 49). Both groups measured their INR using the CoaguChek S every 2 weeks or more frequently if required, for a period of 6 months. Seventy-seven of 104 (74%) patients completed the study (PSM = 41 and PST = 36). The 'drop out' rates for both groups were similar. There was no significant difference between the percentage time in target therapeutic range for PSM (69.9%) and PST (71.8%). Both groups combined showed a significant improvement over the previous 6 months (71.0% vs. 62.5%; P = 0.04). Changes in time within the therapeutic range in individual patients (+5.86) also showed a significant difference. The quality of warfarin control in both PST and PSM may be superior to that achieved by conventional management in a specialised hospital anticoagulation clinic.

Administration, Oral↗

PubMed2005

Management of ankle sprains: a randomised controlled trial of the treatment of inversion injuries using an elastic support bandage or an Aircast ankle brace.

BACKGROUND: Lateral ligament ankle sprains are the single most common sports injury. OBJECTIVE: To determine the functional outcome of the ankle joint after a moderate or severe inversion injury, comparing standard treatment with an elastic support bandage against an Aircast ankle brace. DESIGN: Prospective, randomised controlled trial. SETTING: Two accident and emergency departments. METHOD: Fifty patients presenting consecutively were randomised into two equal groups: one group was treated with an elastic support bandage and the other with an Aircast ankle brace. All patients were given a standardised advice sheet referring to rest, ice, compression, and elevation. Patients were reviewed after 48-72 hours, 10 days, and one month. PRIMARY OUTCOME MEASURE: Ankle joint function assessed at 10 days and one month using the modified Karlsson scoring method (maximum score 90). SECONDARY OUTCOME MEASURE: The difference in ankle girth (swelling) and pain score at 10 days. RESULTS: Seventeen patients in the elastic support bandage group (six defaulted, two excluded) and 18 patients in the Aircast ankle brace group (six defaulted, one excluded) completed the study. There were no significant differences between the two groups at presentation in terms of age (mean 35.3 and 32.6 years respectively), sex, dominant leg, left or right ankle injured, previous injury, time to presentation (median three and four hours respectively), difference in ankle girth (mean 14.5 and 14.3 mm respectively), and pain scores (mean 6.2 and 5.8 respectively). The Karlsson score was significantly higher in the Aircast ankle cast group than in the elastic bandage group at 10 days (mean 50 v 35, p = 0.028, 95% confidence interval (CI) 1.7 to 27.7) and one month (mean 68 v 55, p = 0.029, 95% CI 1.4 to 24.8) (Student's t test). There was no difference between the groups in the secondary outcome measures (swelling, p = 0.09; pain, p = 0.07). When hierarchical multiple regression analysis was used to correct for possible baseline confounding factors, the Aircast ankle brace group was significantly associated with higher Karlsson scores at 10 days (p = 0.009) and one month (p = 0.024). CONCLUSION: The use of an Aircast ankle brace for the treatment of lateral ligament ankle sprains produces a significant improvement in ankle joint function at both 10 days and one month compared with standard management with an elastic support bandage.

Adolescent↗

PubMed2005

Brief psychotherapy in Alzheimer's disease: randomised controlled trial.

BACKGROUND: Although there is good evidence that interventions for carers of people with Alzheimer's disease can reduce stress, no systematic studies have investigated psychotherapeutic intervention for patients themselves. This may be important in the earlier stages of Alzheimer's disease, where insight is often preserved. AIMS: The aim was to assess, in a randomised controlled trial, whether psychotherapeutic intervention could benefit cognitive function, affective symptoms and global well-being. METHOD: Individuals were randomised to receive six sessions of psychodynamic interpersonal therapy or treatment as usual; cognitive function, activities of daily living, a global measure of change, and carer stress and coping were assessed prior to and after the intervention. RESULTS: No improvement was found on the majority of outcome measures. There was a suggestion that therapy had improved the carers' reactions to some of the symptoms. CONCLUSIONS: There is no evidence to support the widespread introduction of brief psychotherapeutic approaches for those with Alzheimer's disease. However, the technique was acceptable and helpful individually.

Activities of Daily Living↗