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Results for “Randomised Controlled Trial”

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At least 397 records · Page 22Linked to original sources

PubMed2005

Does home based medication review keep older people out of hospital? The HOMER randomised controlled trial.

OBJECTIVE: To determine whether home based medication review by pharmacists affects hospital readmission rates among older people. DESIGN: Randomised controlled trial. SETTING: Home based medication review after discharge from acute or community hospitals in Norfolk and Suffolk. PARTICIPANTS: 872 patients aged over 80 recruited during an emergency admission (any cause) if returning to own home or warden controlled accommodation and taking two or more drugs daily on discharge. INTERVENTION: Two home visits by a pharmacist within two weeks and eight weeks of discharge to educate patients and carers about their drugs, remove out of date drugs, inform general practitioners of drug reactions or interactions, and inform the local pharmacist if a compliance aid is needed. Control arm received usual care. MAIN OUTCOME MEASURE: Total emergency readmissions to hospital at six months. Secondary outcomes included death and quality of life measured with the EQ-5D. RESULTS: By six months 178 readmissions had occurred in the control group and 234 in the intervention group (rate ratio = 1.30, 95% confidence interval 1.07 to 1.58; P = 0.009, Poisson model). 49 deaths occurred in the intervention group compared with 63 in the control group (hazard ratio = 0.75, 0.52 to 1.10; P = 0.14). EQ-5D scores decreased (worsened) by a mean of 0.14 in the control group and 0.13 in the intervention group (difference = 0.01, -0.05 to 0.06; P = 0.84, t test). CONCLUSIONS: The intervention was associated with a significantly higher rate of hospital admissions and did not significantly improve quality of life or reduce deaths. Further research is needed to explain this counterintuitive finding and to identify more effective methods of medication review.

Aftercare↗

PubMed2006

Effectiveness of an influenza vaccine programme for care home staff to prevent death, morbidity, and health service use among residents: cluster randomised controlled trial.

OBJECTIVE: To determine whether vaccination of care home staff against influenza indirectly protects residents. DESIGN: Pair matched cluster randomised controlled trial. SETTING: Large private chain of UK care homes during the winters of 2003-4 and 2004-5. PARTICIPANTS: Nursing home staff (n=1703) and residents (n=2604) in 44 care homes (22 intervention homes and 22 matched control homes). INTERVENTIONS: Vaccination offered to staff in intervention homes but not in control homes. MAIN OUTCOME MEASURES: The primary outcome was all cause mortality of residents. Secondary outcomes were influenza-like illness and health service use in residents. RESULTS: In 2003-4 vaccine coverage in full time staff was 48.2% (407/884) in intervention homes and 5.9% (51/859) in control homes. In 2004-5 uptake rates were 43.2% (365/844) and 3.5% (28/800). National influenza rates were substantially below average in 2004-5. In the 2003-4 period of influenza activity significant decreases were found in mortality of residents in intervention homes compared with control homes (rate difference -5.0 per 100 residents, 95% confidence interval -7.0 to -2.0) and in influenza-like illness (P=0.004), consultations with general practitioners for influenza-like illness (P=0.008), and admissions to hospital with influenza-like illness (P=0.009). No significant differences were found in 2004-5 or during periods of no influenza activity in 2003-4. CONCLUSIONS: Vaccinating care home staff against influenza can prevent deaths, health service use, and influenza-like illness in residents during periods of moderate influenza activity. TRIAL REGISTRATION: National Research Register N0530147256.

Aged↗

PubMed2026

Interventions to improve school attendance: a systematic review and meta-analysis of evidence from randomised controlled trials.

BACKGROUND: Poor school attendance adversely affects youth behaviour and health trajectories. We reviewed and synthesised the evidence from randomised controlled trials (RCTs) on interventions to improve school attendance. METHODS: This systematic review and meta-analysis updates the Education Endowment Foundation (EEF) 2022 review on attendance interventions. We synthesised RCT data to inform recommendations. We searched ERIC (via EBSCOhost), PsycINFO, Web of Science and Google Scholar for publications 1 January 2020-16 October 2024 to identify attendance interventions delivered to students, parents/guardians or school staff. We also extracted and analysed RCTs identified in the EEF review. Two reviewers independently extracted data from published articles and assessed risk of bias and certainty of evidence (Grading of Recommendations Assessment, Development and Evaluation, GRADE assessment). We synthesised and meta-analysed data per our protocol (PROSPERO: CRD42024610037). RESULTS: We screened 9366 titles and abstracts and included 61 articles (2000-2024): 43 articles published 2020-2024 plus 18 articles from the previous review (2000-2020), reporting 57 trials of 54 interventions. Pooled mean difference and 95% CIs for days of school attended was 0.63 (-0.34 to 1.61), I2=64.0%, low certainty, for mentoring interventions and 0.43 (0.10 to 0.76), I2=91.9%, moderate certainty, for parental engagement interventions. Other intervention areas including targeted approaches, behavioural programmes and social-emotional interventions had smaller, heterogeneous evidence bases. Risk of bias was moderate-to-low in most trials. CONCLUSION: A large range of interventions exist to address the diverse causes of school absence. Parental engagement demonstrated a small positive effect on attendance, particularly among younger age groups. Most trials were from the USA; implementation and evaluation in other countries will inform effectiveness.

CHILD↗

PubMed1998

Home vaccination for children behind in their immunisation schedule: a randomised controlled trial.

OBJECTIVE: To ascertain the effectiveness of a home vaccination service for children behind in their vaccination schedule. DESIGN: Randomised controlled trial of nurse-administered vaccination at home. Children were allocated at random to the intervention or the control group before any contact with the parents was made. SETTING: 10 council areas in north-west metropolitan Melbourne defined by 56 postcode zones. Six-week intervention period from November 1996. PARTICIPANTS: 405 children--all those in the study area (n = 2610) 90 days late (age 9 months) for their third diphtheria-tetanus-pertussis/poliomyelitis/Haemophilus influenzae type B (DTP/OPV/Hib) vaccination, or 120 days late (age 16 months) for their measles-mumps-rubella (MMR) vaccination, according to the Australia Childhood Immunisation Register. MAIN OUTCOME MEASURES: Number of children completing DTP/OPV/Hib or MMR during the intervention period, and number up to date before intervention. RESULTS: Verification of vaccination status with the parents revealed that 123 (60%) of the children in the intervention group and 113 (56%) of those in the control group were up to date with their vaccinations, leaving a study population of 81 (intervention group) and 88 (control group). Vaccination was achieved in 46 (57%) intervention children and 24 (27%) control children (risk ratio [RR], 2.08; 95% CI, 1.4-3.1; P < 0.001). For DTP/OPV/Hib, 18/32 (56%) intervention children and 12/36 (33%) control children were vaccinated, (P = 0.06). For MMR, 28/49 (57%) and 12/52 (23%) children were vaccinated, respectively (P < 0.001). Home vaccinations were completed with 26 families (including five siblings). The average cost per child vaccinated as a result of the home program was $92.52. CONCLUSION: Home vaccination for children behind in their immunisation schedule is an effective, acceptable and relatively cheap method of completing recommended vaccinations. We recommend that a home vaccination program be widely implemented and made available, particularly for disadvantaged families.

Australia↗

PubMed2002

Treatment outcome of headache after occlusal appliance therapy in a randomised controlled trial among patients with temporomandibular disorders of mainly arthrogenous origin.

The aim of this study was to evaluate headaches before and after treatment with a stabilisation appliance and a control appliance in a randomised controlled trial in patients having temporomandibular disorders (TMD) of mainly arthrogenous origin. The effect of treatment was evaluated both in a short and in long-term perspective. 60 patients (mean age 30 years) with TMD of mainly arthrogenous origin were studied. The patients were selected from patients referred for treatment of TMD during a 3-year period to the Department of Stomathognathic Physiology, Faculty of Odontology, Malmö University. The 60 patients included in the study were randomly assigned to a treatment (T) or a control (C) group. The study was performed as a randomised controlled trial including evaluation of treatment effect on tension-type headache after 10 weeks, 6 and 12 months. At the 10 weeks follow-up, the patients who reported a negative treatment outcome and/or discomfort associated with the use of the appliances had their appliances readjusted. Patients who demanded further treatment received a stabilisation appliance (21 patients from the C-group), creating a new mixed (M) group. All the 60 patients reported frequency of headache from rarely up to daily at the start of the study. In the T-group 76% and in the C-group 83% of the patients reported headache at least once a week or more before treatment. At the 10 weeks follow-up, a statistically significant difference was found regarding headache several times a week or more between the T- and C-groups and within the T-group. At the 6 months follow-up, a statistically significant reduction was found in headache several times a week or more in the T- and M-groups. The number of patients with headache once a week or more decreased significantly in the T- and M-groups at the 12 months follow-up. We conclude that the stabilisation appliance seems to have an effect on the frequency of tension-type headache both in a short and in a long-term perspective in patients with TMD of mainly arthrogenous origin.

Adult↗

PubMed2005

Screening for abdominal aortic aneurysms: single centre randomised controlled trial.

OBJECTIVE: To determine whether screening Danish men aged 65 or more for abdominal aortic aneurysms reduces mortality. DESIGN: Single centre randomised controlled trial. SETTING: All five hospitals in Viborg County, Denmark. PARTICIPANTS: All 12,639 men born during 1921-33 and living in Viborg County. In 1994 we included men born 1921-9 (64-73 years). We also included men who became 65 during 1995-8. INTERVENTIONS: Men were randomised to the intervention group (screening by abdominal ultrasonography) or control group. Participants with an abdominal aortic aneurysm > 5 cm were referred for surgical evaluation, and those with smaller aneurysms were offered annual scans. OUTCOME MEASURES: Specific mortality due to abdominal aortic aneurysm, overall mortality, and number of planned and emergency operations for abdominal aortic aneurysms. RESULTS: 4860 of 6333 men were screened (attendance rate 76.6%). 191 (4.0% of those screened) had abdominal aortic aneurysms. The mean follow-up time was 52 months. The screened group underwent 75% (95% confidence interval 51% to 91%) fewer emergency operations than the control group. Deaths due to abdominal aortic aneurysms occurred in nine patients in the screened group and 27 in the control group. The number needed to screen to save one life was 352. Specific mortality was significantly reduced by 67% (29% to 84%). Mortality due to non-abdominal aortic aneurysms was non-significantly reduced by 8%. The benefits of screening may increase with time. CONCLUSION: Mass screening for abdominal aortic aneurysms in Danish men aged 65 or more reduces mortality.

Aged↗

PubMed1995

Social services case-management for long-term mental disorders: a randomised controlled trial.

Case management arose in the USA as a solution to the difficulties of providing community care to people with severe mental disorders. The basic principle of the approach is that a case manager takes responsibility for a client; arranges an assessment of need, a comprehensive service plan, delivery of suitable services, and monitoring and assessment of services delivered. The case-management approach has been widely accepted, to the extent that recent legislation has made case-management the cornerstone of community care in the UK. We did a randomised controlled trial to evaluate a social services case-management team for people with long-term mental disorders. Subjects were referred from hostels for the homeless, night shelters, a general-practitioner clinic for the homeless, the Oxford City Council homelessness unit, and local voluntary-sector group homes. Of 103 subjects referred, 80 consented to be randomised to treatment or control groups. At 14-month follow-up, as assessed by standardised interviews, there were no significant differences between groups in number of needs, quality of life, employment status, quality of accommodation, social behaviour, or severity of psychiatric symptoms. In the case-management group there was a significant reduction in deviant behaviour on a standardised behaviour rating scale (REHAB) (mean = 0.79; 95% CI 0.26-1.32). It is unfortunate, in view of the limited effectiveness we have shown, that social services case-management was not evaluated in randomised controlled trials before its implementation in the UK.

Adult↗

PubMed2005

Cognitive behaviour therapy in addition to antispasmodic treatment for irritable bowel syndrome in primary care: randomised controlled trial.

OBJECTIVE: To assess the efficacy of cognitive behaviour therapy delivered in primary care for treating irritable bowel syndrome. DESIGN: Randomised controlled trial. SETTING: 10 general practices in London. PARTICIPANTS: 149 patients with moderate or severe irritable bowel syndrome resistant to the antispasmodic mebeverine. INTERVENTIONS: Cognitive behaviour therapy delivered by trained primary care nurses plus 270 mg mebeverine taken thrice daily compared with mebeverine treatment alone. MAIN OUTCOME MEASURES: Primary measures were patients' scores on the irritable bowel syndrome symptom severity scale. Secondary measures were scores on the work and social adjustment scale and the hospital anxiety and depression scale. RESULTS: Of 334 referred patients, 72 were randomised to mebeverine plus cognitive behaviour therapy and 77 to mebeverine alone. Cognitive behaviour therapy had considerable initial benefit on symptom severity compared with mebeverine alone, with a mean reduction in score of 68 points (95% confidence interval 103 to 33), with the benefit persisting at three months and six months after therapy (mean reductions 71 points (109 to 32) and 11 points (20 to 3)) but not later. Cognitive behaviour therapy also showed significant benefit on the work and social adjustment scale that was still present 12 months after therapy (mean reduction 2.8 points (5.2 to 0.4)), but had an inconsistent effect on the hospital anxiety and depression scale. CONCLUSION: Cognitive behaviour therapy delivered by primary care nurses offered additional benefit over mebeverine alone up to six months, although the effect had waned by 12 months. Such therapy may be useful for certain patients with irritable bowel syndrome in primary care.

Adolescent↗

PubMed2006

Self management of arthritis in primary care: randomised controlled trial.

OBJECTIVE: To evaluate clinical effectiveness of a self management programme for arthritis in patients in primary care with osteoarthritis. DESIGN: Randomised controlled trial. SETTING: 74 general practices in the United Kingdom. PARTICIPANTS: 812 patients aged 50 and over with osteoarthritis of hips or knees (or both) and pain or disability (or both). INTERVENTION: Participants were randomised to six sessions of self management of arthritis and an education booklet (intervention group) or the education booklet alone (control group). MAIN OUTCOME MEASURES: Primary outcome was quality of life, as assessed by the short form health survey (SF-36). Several other physical and psychosocial secondary outcomes were assessed. Data were collected at baseline, four months, and 12 months. RESULTS: Response rates were 80% and 76% at four and 12 months. The two groups showed significant differences at 12 months on the anxiety subscore of the hospital anxiety and depression scale (mean difference -0.62, 95% confidence interval -1.08 to -0.16), arthritis self efficacy scale for pain (0.98, 0.07 to 1.89), and self efficacy for other aspects of management (1.58, 0.25 to 2.90). Results were similar for intention to treat and per protocol analyses. No significant difference was seen in number of visits to the general practitioner at 12 months. CONCLUSIONS: The self management of arthritis programme reduced anxiety and improved participants' perceived self efficacy to manage symptoms, but it had no significant effect on pain, physical functioning, or contact with primary care. TRIAL REGISTRATION: Current Controlled Trials ISRCTN79115352 [controlled-trials.com].

Aged↗

PubMed1998

Screening for hypercholesterolaemia in primary care: randomised controlled trial of postal questionnaire appraising risk of coronary heart disease.

OBJECTIVES: To validate a self administered postal questionnaire appraising risk of coronary heart disease. To determine whether use of this questionnaire increased the percentage of people at high risk of coronary heart disease and decreased the percentage of people at low risk who had their cholesterol concentration measured. DESIGN: Validation was by review of medical records and clinical assessment. The questionnaire appraising risk of coronary heart disease encouraged those meeting criteria for cholesterol measurement to have a cholesterol test and was tested in a randomised controlled trial. The intervention group was sent the risk appraisal questionnaire with a health questionnaire that determined risk of coronary heart disease without identifying the risk factors as related to coronary heart disease; the control group was sent the health questionnaire alone. SETTING: One capitation funded primary care practice in Canada with an enrolled patient population of about 12 000. SUBJECTS: Random sample of 100 participants in the intervention and control groups were included in the validation exercise. 5686 contactable patients aged 20 to 69 years who on the basis of practice records had not had a cholesterol test performed during the preceding 5 years were included in the randomised controlled trial. 2837 were in the intervention group and 2849 were in the control group. MAIN OUTCOME MEASURES: Sensitivity and specificity of assessment of risk of coronary heart disease with risk appraisal questionnaire. Rate of cholesterol testing during three months of follow up. RESULTS: Sensitivity of questionnaire appraising coronary risk was 87.5% (95% confidence interval 73.2% to 95.8%) and specificity 91.7% (81.6% to 97.2%). Of the patients without pre-existing coronary heart disease who met predefined screening criteria based on risk, 45 out of 421 in the intervention group (10.7%) and 9 out of 504 in the control group (1.8%) had a cholesterol test performed during follow up (P<0.0001). Of the patients without a history of coronary heart disease who did not meet criteria for cholesterol testing, 30 out of 1128 in the intervention group (2.7%) and 18 out of 1099 in the control group (1.6%) had a cholesterol test (P=0.175). Of the patients with pre-existing coronary heart disease, 1 out of 15 in the intervention group (6.7%) and 1 out of 23 in the control group (4.3%) were tested during follow up (P=0.851, one tailed Fisher's exact test). CONCLUSIONS: Although the questionnaire appraising coronary risk increased the percentage of people at high risk who obtained cholesterol testing, the effect was small. Most patients at risk who received the questionnaire did not respond by having a test.

Adult↗

PubMed2006

Randomised controlled trial of cervical radiofrequency lesions as a treatment for cervicogenic headache [ISRCTN07444684].

BACKGROUND: Cervicogenic headache (CEH) is a unilateral headache localised in the neck or occipital region, projecting to the frontal and temporal regions. Since the pathogenesis of this syndrome appears to have an anatomical basis in the cervical region, several surgical procedures aimed at reducing the nociceptive input on the cervical level, have been tested. We developed a sequence of various cervical radiofrequency neurotomies (facet joint denervations eventually followed by upper dorsal root ganglion neurotomies) that proved successful in a prospective pilot trial with 15 CEH patients. To further evaluate this sequential treatment program we conducted a randomised controlled trial METHODS: 30 patients with cervicogenic headache according to the Sjaastad diagnostic criteria, were randomised. 15 patients received a sequence of radiofrequency treatments (cervical facet joint denervation, followed by cervical dorsal root ganglion lesions when necessary), and the other 15 patients underwent local injections with steroid and anaesthetic at the greater occipital nerve, followed by transcutaneous electrical nerve stimulation (TENS) when necessary. Visual analogue scores for pain, global perceived effects scores, quality of life scores were assessed at 8, 16, 24 and 48 weeks. Patients also kept a headache diary. RESULTS: There were no statistically significant differences between the two treatment groups at any time point in the trial. CONCLUSION: We did not find evidence that radiofrequency treatment of cervical facet joints and upper dorsal root ganglions is a better treatment than the infiltration of the greater occipital nerve, followed by TENS for patients fulfilling the clinical criteria of cervicogenic headache.

Journal Article↗

PubMed2005

Protocol for Project FACT: a randomised controlled trial on the effect of a walking program and vitamin B supplementation on the rate of cognitive decline and psychosocial wellbeing in older adults with mild cognitive impairment [ISRCTN19227688].

BACKGROUND: The prevalence of individuals with cognitive decline is increasing since the number of elderly adults is growing considerably. The literature provides promising results on the beneficial effect of exercise and vitamin supplementation on cognitive function both in cognitively healthy as well as in the demented elderly. METHODS/DESIGN: The design is a two-by-two factorial randomised controlled trial. The study population consists of independently living elderly, between 70 and 80 years old, with mild cognitive impairment (MCI). In the RCT the effect of two interventions, a walking program and vitamin supplementation, is examined. The walking program (WP) is a group-based program aimed at improving cardiovascular endurance; frequency two lessons a week; lesson duration one hour; program duration one year. Non-walking groups receive a placebo activity program (PAP) (i.e. low intensive non-aerobic group exercises, like stretching) with the same frequency, lesson and program duration. Vitamin supplementation consists of a single daily vitamin supplement containing 50 mg B6, 5 mg folic acid and 0,4 mg B12 for one year. Subjects not receiving vitamin supplements are daily taking an identically looking placebo pill, also for a year. Participants are randomised to four groups 1) WP and vitamin supplements; 2) WP and placebo supplements; 3) PAP and vitamin supplements; 4) PAP and placebo supplements. Primary outcome measures are measures of cognitive function. Secondary outcomes include psychosocial wellbeing, physical activity, cardiovascular endurance and blood vitamin levels. DISCUSSION: No large intervention study has been conducted yet on the effect of physical activity and vitamin supplementation in a population-based sample of adults with MCI. The objective of the present article is to describe the design of a randomised controlled trial examining the effect of a walking program and vitamin B supplementation on the rate of cognitive decline in older adults with MCI.

Aged↗

PubMed2006

Human papillomavirus testing and liquid-based cytology in primary screening of women younger than 35 years: results at recruitment for a randomised controlled trial.

BACKGROUND: Testing for human papillomavirus (HPV) DNA is more sensitive but less specific than cytological analysis. Loss in specificity is most relevant in women younger than 35 years because of increased HPV prevalence. We aimed to compare conventional screening with an experimental strategy in women aged 25-34 years, and investigate the effect of different criteria of referral to define the best methods of HPV screening. METHODS: Women were randomly assigned to the conventional procedure (standard cytology, with referral to colposcopy if cytology showed atypical squamous cells of undetermined significance or more [ASCUS+]) or an experimental procedure (liquid-based cytology and testing for high-risk HPV types, with referral to colposcopy with ASCUS+ cytology). Women positive for HPV (cutoff > or = 1 pg/mL) but with normal cytology were retested after 1 year. The main endpoint was the presence of cervical intraepithelial neoplasia at grade 2 or more (CIN2+) in reviewed histology. The main analysis was by intention to screen. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN81678807. FINDINGS: We randomly assigned 5808 women aged 25-34 years to the conventional group and 6002 to the experimental group. The experimental procedure was significantly more sensitive than the conventional procedure (55 vs 33 CIN2+ lesions detected; relative sensitivity 1.61 [95% CI 1.05-2.48]), but had a lower positive predictive value (PPV; relative PPV 0.55 [0.37-0.82]). HPV testing (> or = 1 pg/mL) with cytology triage was also more sensitive than conventional cytology (relative sensitivity 1.58 [1.03-2.44], relative PPV 0.78 [0.52-1.16]). Relative PPV could be improved, with minimum loss in sensitivity, by use of a 2 pg/mL cutoff for HPV testing. Compared with conventional cytology, liquid-based cytology had a relative sensitivity of 1.32 (0.84-2.06), relative PPV 0.58 [0.38-0.89]). INTERPRETATION: HPV testing alone with cytology triage could be a feasible alternative to conventional cytology for screening women younger than 35 years. Follow-up will provide data on possible overdiagnosis and on the feasibility of extended intervals.

Adult↗

PubMed2003

Multifactorial intervention after a fall in older people with cognitive impairment and dementia presenting to the accident and emergency department: randomised controlled trial.

OBJECTIVE: To determine the effectiveness of multifactorial intervention after a fall in older patients with cognitive impairment and dementia attending the accident and emergency department. DESIGN: Randomised controlled trial. PARTICIPANTS: 274 cognitively impaired older people (aged 65 or over) presenting to the accident and emergency department after a fall: 130 were randomised to assessment and intervention and 144 were randomised to assessment followed by conventional care (control group). SETTING: Two accident and emergency departments, Newcastle upon Tyne. MAIN OUTCOME MEASURES: Primary outcome was number of participants who fell in year after intervention. Secondary outcomes were number of falls (corrected for diary returns), time to first fall, injury rates, fall related attendances at accident and emergency department, fall related hospital admissions, and mortality. RESULTS: Intention to treat analysis showed no significant difference between intervention and control groups in proportion of patients who fell during 1 year's follow up (74% (96/130) and 80% (115/144), relative risk ratio 0.92, 95% confidence interval 0.81 to 1.05). No significant differences were found between groups for secondary outcome measures. CONCLUSIONS: Multifactorial intervention was not effective in preventing falls in older people with cognitive impairment and dementia presenting to the accident and emergency department after a fall.

Accidental Falls↗

PubMed2002

Home based exercise programme for knee pain and knee osteoarthritis: randomised controlled trial.

OBJECTIVES: To determine whether a home based exercise programme can improve outcomes in patients with knee pain. DESIGN: Pragmatic, factorial randomised controlled trial of two years' duration. SETTING: Two general practices in Nottingham. PARTICIPANTS: 786 men and women aged >/=45 years with self reported knee pain. INTERVENTIONS: Participants were randomised to four groups to receive exercise therapy, monthly telephone contact, exercise therapy plus telephone contact, or no intervention. Patients in the no intervention and combined exercise and telephone groups were randomised to receive or not receive a placebo health food tablet. MAIN OUTCOME MEASURES: Primary outcome was self reported score for knee pain on the Western Ontario and McMaster universities (WOMAC) osteoarthritis index at two years. Secondary outcomes included knee specific physical function and stiffness (scored on WOMAC index), general physical function (scored on SF-36 questionnaire), psychological outlook (scored on hospital anxiety and depression scale), and isometric muscle strength. RESULTS: 600 (76.3%) participants completed the study. At 24 months, highly significant reductions in knee pain were apparent for the pooled exercise groups compared with the non-exercise groups (mean difference -0.82, 95% confidence interval -1.3 to -0.3). Similar improvements were observed at 6, 12, and 18 months. Regular telephone contact alone did not reduce pain. The reduction in pain was greater the closer patients adhered to the exercise plan. CONCLUSIONS: A simple home based exercise programme can significantly reduce knee pain. The lack of improvement in patients who received only telephone contact suggests that improvements are not just due to psychosocial effects because of contact with the therapist.

Arthralgia↗

PubMed1988

A randomised controlled trial of adjuvant hormono-chemotherapy in Stage II breast cancer.

From 1979 to 1984 women with histologically proven Stage II breast cancer were entered into a randomised controlled trial of adjuvant hormono-chemotherapy following mastectomy. Adjuvant therapy was started within 2 weeks of surgery and was given for 6 months as continuous 'Tamoxifen' and 6-monthly cycles of vincristine, adriamycin and cyclophosphamide (VAC). Of the 157 women randomised 82 were assigned to the control group and 75 to the adjuvant group. Comparing the two groups by life table analysis the rate of recurrence was found to be significantly greater in the control group (n = 46) than in the adjuvant group (n = 25) (Peto log rank test chi 2 = 7.46 P less than 0.01). Although there were more deaths amongst the control patients (n = 31) than in those randomised to receive adjuvant therapy (n = 18), this difference did not achieve statistical significance (chi 2 = 2.80 P less than 0.1). This analysis has shown that although adjuvant hormono-chemotherapy may significantly delay recurrence the trial has failed to demonstrate any significant improvement in the survival of women with Stage II breast cancer following mastectomy.

Adult↗

PubMed2003

A cluster-randomised controlled trial of a patient-centred guidebook for patients with ulcerative colitis: effect on knowledge, anxiety and quality of life.

A randomised controlled trial was undertaken to evaluate the impact of a patient-centred, evidence-based guidebook on knowledge, anxiety and quality of life (QoL) in patients with ulcerative colitis. The information in the book was developed closely with patients and focused on their identified needs. All 240 subjects in the study were on long-term follow-up for ulcerative colitis and were effectively responsible for the day-to-day management of their condition in the community. Outcomes were measured at 1 month and 9 months. Patients attended outpatient clinics at six hospitals: three hospitals were randomised to be control sites; and three were intervention sites where patients were given a copy of the guidebook. The results showed that patients receiving the guidebook demonstrated significantly better knowledge of their ulcerative colitis at 1 month, which persisted at 9 months, than patients in the control group. Anxiety and QoL scores were unchanged throughout. The present authors conclude that appropriate information is an essential prerequisite to greater patient involvement in chronic disease management. Patient-centred information increases knowledge without increasing anxiety and should be made available to patients through an appropriate health provider.

Adolescent↗

PubMedDate not supplied

Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911).

BACKGROUND: Local failure after prostatectomy can arise in patients with cancer extending beyond the capsule. We did a randomised controlled trial to compare radical prostatectomy followed by immediate external irradiation with prostatectomy alone for patients with positive surgical margin or pT3 prostate cancer. METHODS: After undergoing radical retropubic prostatectomy, 503 patients were randomly assigned to a wait-and-see policy, and 502 to immediate postoperative radiotherapy (60 Gy conventional irradiation delivered over 6 weeks). Eligible patients had pN0M0 tumours and one or more pathological risk factors: capsule perforation, positive surgical margins, invasion of seminal vesicles. Our revised primary endpoint was biochemical progression-free survival. Analysis was by intention to treat. FINDINGS: The median age was 65 years (IQR 61-69). After a median follow-up of 5 years, biochemical progression-free survival was significantly improved in the irradiated group (74.0%, 98% CI 68.7-79.3 vs 52.6%, 46.6-58.5; p<0.0001). Clinical progression-free survival was also significantly improved (p=0.0009). The cumulative rate of locoregional failure was significantly lower in the irradiated group (p<0.0001). Grade 2 or 3 late effects were significantly more frequent in the postoperative irradiation group (p=0.0005), but severe toxic toxicity (grade 3 or higher) were rare, with a 5-year rate of 2.6% in the wait-and-see group and 4.2% in the postoperative irradiation group (p=0.0726). INTERPRETATION: Immediate external irradiation after radical prostatectomy improves biochemical progression-free survival and local control in patients with positive surgical margins or pT3 prostate cancer who are at high risk of progression. Further follow-up is needed to assess the effect on overall survival.

Adenocarcinoma↗