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Results for “Randomised Controlled Trial”

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PubMed2002

Cluster randomised controlled trial of an educational outreach visit to improve influenza and pneumococcal immunisation rates in primary care.

BACKGROUND: Improvement in the delivery of influenza and pneumococcal vaccinations to high-risk groups is an important aspect of preventive care for primary healthcare teams. AIM: To investigate the effect of an educational outreach visit to primary healthcare teams on influenza and pneumococcal vaccination uptake in high-risk patients. DESIGN: Cluster randomised controlled trial. SETTING: Thirty general practices in the Trent region, UK. METHODS: Fifteen practices were randomised to intervention and 15 to the control group after stratifying for baseline vaccination rate. All intervention practices were offered and received an educational outreach visit to primary healthcare teams, in addition to audit and feedback directed at improving influenza and pneumococcal vaccination rates in high-risk groups. Control practices received audit and feedback alone. All practices measured influenza and pneumococcal vaccination rates in high-risk groups. Primary outcomes were improvements in vaccination rates in patients aged 65 years and over, and patients with coronary heart disease (CHD), diabetes and a history of splenectomy. RESULTS: Improvements in pneumococcal vaccination rates in the intervention practices were significantly greater compared with controls in patients with CHD, 14.8% versus 6.5% (odds ratio [OR] = 1.23, 95% confidence interval [CI] = 1.13 to 1.34) and diabetes, 15.5% versus 6.8% (OR = 1.18, 95% CI = 1.08 to 1.29) but not splenectomy, 6.5% versus 4.7% (OR = 0.96, 95% CI = 0.65 to 1.42). Improvements for influenza vaccination were also usually greater in intervention practices but did not reach statistical significance. The increases for influenza vaccination in intervention versus control practices were for CHD, 18.1% versus 13.1% (OR = 1.06, 95% CI = 0.99 to 1.12); diabetes, 15.5% versus 12.0% (OR = 1.07, 95% CI = 0.99 to 1.16), splenectomy 16.1% versus 2.9% (OR = 1.22, 95% CI = 0.78 to 1.93); and those over 65 years 20.7% versus 25.4% (OR = 0.99, 95% CI = 0.96 to 1.02). CONCLUSION: Practices where primary care teams received an educational outreach visit demonstrated a significantly greater improvement in uptake in high-risk groups for pneumococcal but not influenza vaccine.

Aged↗

PubMed2005

A randomised controlled trial of microwave endometrial ablation without endometrial preparation in the outpatient setting: patient acceptability, treatment outcome and costs.

OBJECTIVE: To compare outpatient microwave endometrial ablation (MEA) in the postmenstrual phase to standard MEA treatment after drug preparation in a day case theatre environment. DESIGN: A randomised controlled trial. SETTING: A large United Kingdom teaching hospital. POPULATION: Two hundred and ten women complaining of excessive menstrual loss. METHODS: Two hundred and ten women with excessive menstrual loss were randomised. Ninety-seven women were treated as outpatients in the immediate post-menstrual phase and 100 were treated in an operating theatre after hormonal preparation. All procedures were commenced under local anaesthesia with or without conscious sedation. Analysis was by modified intention to treat. MAIN OUTCOME MEASURES: Primary outcome measures were satisfaction with treatment (measured at one year) and acceptability of treatment (measured at two weeks). Secondary outcome measures were menstrual outcome and financial cost. RESULTS: Significantly more women found treatment post-menses acceptable; 86 (89.5%) versus 76 (76.0%) [difference in proportions 13.6%, 95% CI (3.0%, 23.9%)]. Similar numbers in each arm were totally or generally satisfied with the treatment, 86 (92.5%) versus 84 (88.4%) [difference in proportions 4.1%, 95% CI (-4.7%, 12.9%)] while amenorrhoea rates at one year were comparable, 52 (55.9%) versus 60 (61.9%). [difference in proportions -5.9%, 95% CI (-19.8%, 7.6%)]. The mean health service costs were 124 pounds (95% CI 86-194 pounds) lower for the patients in the post-menses group. CONCLUSION: MEA performed under local anaesthesia (with or without conscious sedation) in the post-menstrual phase achieves high levels of satisfaction is very acceptable to patients and results in significantly reduced health service costs. Importantly menstrual outcomes are not affected by omission of drug preparation. There is now good evidence to support the use of MEA, without drug endometrial preparation, in the outpatient setting.

Adult↗

PubMed2026

A single session of high-definition transcranial direct current stimulation does not modulate effects of knee two-point discrimination training or sensorimotor function in healthy adults: Double-blind randomised controlled trial.

BACKGROUND: Benefits of sensory-training interventions on sensorimotor outcomes are inconsistent, and it is unclear whether transcranial direct current stimulation (tDCS) can enhance proprioception, which is fundamental to neuromuscular control. Existing evidence is dominated by upper-limb studies, so transferability to the knee is unclear. This study investigated whether a single session of anodal high-definition (HD)-tDCS, alone or combined with brief two-point discrimination (TPD) training, enhances knee sensorimotor function and performance in healthy adults. METHODS: In a double-blind randomised-controlled trial, 57 healthy participants received (1) 20-min, 1 mA anodal HD-tDCS over the knee primary somatosensory (S1) map or sham stimulation, and (2) 15-min knee TPD training or no training. Knee somatosensory, sensorimotor, and functional performance measures were assessed pre- and immediately post-intervention. Three-way mixed-design ANOVAs, equivalence testing (smallest effect size of interest η2 = 0.02), Bayes factors, and linear mixed-effects models quantified effects. RESULTS: HD-tDCS, TPD training, and their sequential combination had no effect on any outcome measure (p ≥ 0.05; η2 ≤ 0.015). Confidence intervals spanned equivalence bounds, and equivalence testing results were non-significant (p ≥ 0.05). Bayes factors (<0.33) showed moderate evidence for the null (no effect). Mixed-effects modelling attributed ≤8% of total variance to intervention fixed effects, with the remainder captured by participant-level random effects. CONCLUSION: A single 20-minute session of 1 mA HD-tDCS, with or without brief TPD training, does not acutely modify knee somatosensory, sensorimotor, or functional performance in healthy adults. Existing evidence at the hand may not translate to the lower limb. Future work should investigate higher-dose, multi-session, task-concurrent, or network-targeted strategies in clinical populations.

Humans↗

PubMed1999

Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses.

BACKGROUND: The Quality of Reporting of Meta-analyses (QUOROM) conference was convened to address standards for improving the quality of reporting of meta-analyses of clinical randomised controlled trials (RCTs). METHODS: The QUOROM group consisted of 30 clinical epidemiologists, clinicians, statisticians, editors, and researchers. In conference, the group was asked to identify items they thought should be included in a checklist of standards. Whenever possible, checklist items were guided by research evidence suggesting that failure to adhere to the item proposed could lead to biased results. A modified Delphi technique was used in assessing candidate items. FINDINGS: The conference resulted in the QUOROM statement, a checklist, and a flow diagram. The checklist describes our preferred way to present the abstract, introduction, methods, results, and discussion sections of a report of a meta-analysis. It is organised into 21 headings and subheadings regarding searches, selection, validity assessment, data abstraction, study characteristics, and quantitative data synthesis, and in the results with "trial flow", study characteristics, and quantitative data synthesis; research documentation was identified for eight of the 18 items. The flow diagram provides information about both the numbers of RCTs identified, included, and excluded and the reasons for exclusion of trials. INTERPRETATION: We hope this report will generate further thought about ways to improve the quality of reports of meta-analyses of RCTs and that interested readers, reviewers, researchers, and editors will use the QUOROM statement and generate ideas for its improvement.

Authorship↗

PubMed2006

[Psychotherapy in bipolar disorders -- randomised controlled trials of treatment efficacy].

On the basis of a vulnerability-stress-model psycho-educative, cognitive-behavioural, family-oriented and interpersonal approaches of psychotherapy for bipolar disorders are described. This is followed by a review of randomised controlled trials investigating the treatment efficacy of psychotherapeutic interventions. These studies show positive results particularly for psychoeducation, cognitive-behavioural therapy and family-oriented therapy. Finally, it is discussed in which respects evidence for the successful implementation of psychotherapy is still missing and why it is so important to move towards manualized psychotherapeutic programs.

Bipolar Disorder↗

PubMed2006

A randomised controlled trial of a decision-aid leaflet to facilitate women's choice between pregnancy termination methods.

OBJECTIVE: To evaluate the effectiveness of a decision aid to help women choose between surgical and medical methods of pregnancy termination. DESIGN: A randomised controlled trial comparing a decision-aid leaflet about termination methods with a control leaflet about contraception. SETTING: An NHS regional centre for pregnancy termination. SAMPLE: All women less than 9 weeks of gestation referred for termination of pregnancy over 7 months in 2002. METHODS: Participants were given an envelope containing either the decision-aid or the control leaflet prior to choosing between medical and surgical termination methods and completed two questionnaires, one immediately after this consultation and another after the termination procedure. MAIN OUTCOME MEASURES: Choice of termination method; measures of effective decision making including risk perception, attitudes and knowledge of both the medical and surgical methods; decisional conflict; anxiety and usefulness of the leaflet. RESULTS: Three hundred and twenty-eight women participated. There was no difference in the method chosen between the groups (60/162 women in the decision-aided group chose a medical method versus 54/164 women in the control group (OR 1.2; 95% CI 0.76-1.9). Women in the decision-aided group had higher knowledge and lower risk-perception scores about both methods, more positive attitudes about the medical method, lower decisional conflict, more stable evaluations of the decision information over time and higher perceived usefulness of information ratings. Anxiety was high but unrelated to leaflet type. CONCLUSIONS: Women made more informed decisions when provided with an evidence-based decision-aid leaflet preceding a routine consultation about choices of termination method.

Abortion, Induced↗

PubMed1989

Randomised controlled trial of lymphoblastoid interferon alfa in Europid men with chronic hepatitis B virus infection.

OBJECTIVE: To confirm the findings of pilot studies that interferon alfa is an effective treatment of Europid men with chronic hepatitis B virus infection. DESIGN: Randomised controlled trial of three months treatment with interferon alfa followed by 12 months of observation. SETTING: Outpatient clinic of a tertiary referral centre. PATIENTS: 37 Treated men (six anti-HIV positive) and 34 untreated men (nine anti-HIV positive) who met the criteria for the trial. Four controls failed to complete follow up. INTERVENTIONS: The treated group received subcutaneous injections of 5-10 MU interferon alfa/m2 daily for five days, then 10 MU/m2 thrice weekly for 11 weeks. Follow up continued at monthly intervals for 12 months. Untreated controls were monitored over the same period. MAIN OUTCOME MEASURE: Hepatitis B e antigen and hepatitis B virus DNA state after 15 months of observation. RESULTS: 12 Of the 37 treated patients cleared hepatitis B e antigen and hepatitis B virus DNA, whereas only one of 30 untreated controls seroconverted over the same period--an increased response rate of 29% (95% confidence interval 13% to 45%). The life table estimate of response at 15 months was 35% in treated patients, an increase of 32% above controls (95% confidence interval 16% to 48%). The response rates in groups by predictive pretreatment variables were 12 of 31 anti-HIV negative patients (excess response 34%; 95% confidence interval 14% to 54%), 12 of 26 with chronic active hepatitis before treatment (excess response 46%; 27% to 65%), and 12 of 21 with a pretreatment serum aspartate aminotransferase activity greater than 70 IU/l (excess response 46%; 16% to 76%). The combination of these factors predicted response with a sensitivity of 100% and a specificity of 80%. Four of the 12 responders, who had all been infected for less than two years, also lost hepatitis B surface antigen. Treatment was well tolerated. CONCLUSIONS: Interferon alfa is effective in the treatment of a proportion of Europid men with chronic hepatitis B virus infection, who might be identified before treatment. Additional strategies are required to improve the rate of response.

Adolescent↗

PubMed1995

Randomised controlled trial of teaching general practitioners to carry out structured assessments of their long term mentally ill patients.

OBJECTIVE: To assess the impact of teaching general practitioners to carry out structured assessments of their long term mentally ill patients. DESIGN: Randomised controlled trial. SETTING: Sixteen group general practices in South Thames (west) region. SUBJECTS: 440 adults disabled by long term mental illness. INTERVENTIONS: Patients were identified by using practice data with help from local psychiatric and social services. In eight practices the practitioners were taught a structured assessment schedule to use with patients every six months for two years. MAIN OUTCOME MEASURES: Changes in drug treatments, referrals, consultation rates, and recording of preventive health data in the two years after intervention. RESULTS: Follow up data were available on 373 patients (84.7%). At least one structured assessment was recorded for 127 patients in the intervention group but only 29 had four assessments recorded. Participating practitioners considered the structured assessment to be time consuming and reported that it did not often lead directly to changes in treatment or referrals. Changes in treatment with neuroleptic drugs and referrals to community psychiatric nurses, however, were significantly more frequent in the intervention group (differences for intervention group minus control group adjusted for activity in two years before intervention were 14.3% (95% confidence interval 4.3% to 24.33%; P < 0.01) for neuroleptic drugs and 13.3% (2.0% to 24.6%; P < 0.05) for referrals). There were no significant differences in psychiatric admissions, use of the Mental Health Act, drug overdoses, prescriptions, referrals or admissions for physical problems, consultation rates, continuity of care, or recording of preventive data. CONCLUSIONS: Teaching general practitioners about the problems of long term mentally ill patients may increase their involvement in patients' psychiatric care. Regular structured assessments do not seem feasible in routine surgery appointments. More training for general practitioners and increased resources such as more nurse time may be necessary if improvements in care of long term mentally ill patients in general practice are to be generalised.

Adult↗

PubMed1998

Randomised controlled trial comparing hospital at home care with inpatient hospital care. II: cost minimisation analysis.

OBJECTIVES: To examine the cost of providing hospital at home in place of some forms of inpatient hospital care. DESIGN: Cost minimisation study within a randomised controlled trial. SETTING: District general hospital and catchment area of neighbouring community trust. SUBJECTS: Patients recovering from hip replacement (n=86), knee replacement (n=86), and hysterectomy (n=238); elderly medical patients (n=96); and patients with chronic obstructive airways disease (n=32). INTERVENTIONS: Hospital at home or inpatient hospital care. MAIN OUTCOME MEASURES: Cost of hospital at home scheme to health service, to general practitioners, and to patients and their families compared with hospital care. RESULTS: No difference was detected in total healthcare costs between hospital at home and hospital care for patients recovering from a hip or knee replacement, or elderly medical patients. Hospital at home significantly increased healthcare costs for patients recovering from a hysterectomy (ratio of geometrical means 1.15, 95% confidence interval 1.04 to 1.29, P=0.009) and for those with chronic obstructive airways disease (Mann-Whitney U test, P=0.01). Hospital at home significantly increased general practitioners' costs for elderly medical patients (Mann-Whitney U test, P<0.01) and for those with chronic obstructive airways disease (P=0.02). Patient and carer expenditure made up a small proportion of total costs. CONCLUSION: Hospital at home care did not reduce total healthcare costs for the conditions studied in this trial, and costs were significantly increased for patients recovering from a hysterectomy and those with chronic obstructive airways disease. There was some evidence that costs were shifted to primary care for elderly medical patients and those with chronic obstructive airways disease.

Adult↗

PubMed2001

Randomised controlled trial of disclosure of emotionally important events in somatisation in primary care.

OBJECTIVE: To test whether a disclosure intervention improves subjective health and reduces medical consumption and sick leave in somatising patients in general practice. DESIGN: Non-blind randomised controlled trial. SETTING: 10 general practices in the Netherlands. PARTICIPANTS: 161 patients who frequently attended general practice with somatising symptoms. INTERVENTION: Patients in the intervention group were visited two to three times and invited to disclose emotionally important events in their life. Control patients received normal care from their general practitioners. MAIN OUTCOME MEASURES: Use of medical services (drugs and healthcare visits), subjective health, and sick leave assessed by self completion questionnaires after 6, 12, and 24 months. RESULTS: Of the 161 patients, 137 completed the trial (85%). Both groups were comparable at baseline. The intervention had no effect on the main outcome measures at any point. Intervention patients made one more visit to health care (95% confidence interval -4 to 6); the use of medicines did not change in both groups (-1 to 1); subjective health improved 3.6 points more in the control group (-11.2 to 4.3); and disclosure patients were on sick leave one more week (-1 to 3). Patients often had a depression or anxiety disorder for which they were not receiving adequate care. CONCLUSION: Although the intervention was well received by patients and doctors, disclosure had no effect on the health of somatising patients in general practice.

Adult↗

PubMed2002

Reducing antibiotic use for acute bronchitis in primary care: blinded, randomised controlled trial of patient information leaflet.

OBJECTIVE: To assess whether sharing the uncertainty of the value of antibiotics for acute bronchitis in the form of written and verbal advice affects the likelihood of patients taking antibiotics. DESIGN: Nested, single blind, randomised controlled trial. SETTING: Three suburban general practices in Nottingham Participants: 259 previously well adults presenting with acute bronchitis. INTERVENTION: In group A, 212 patients were judged by their general practitioner not to need antibiotics that day but were given a prescription to use if they got worse and standard verbal reassurance. Half of them (106) were also given an information leaflet. All patients in group B (47) were judged to need antibiotics and were given a prescription and encouraged to use it. MAIN OUTCOME MEASURES: Antibiotic use in the next two weeks. Reconsultation for the same symptoms in the next month. RESULTS: In group A fewer patients who received the information leaflet took antibiotics compared with those who did not receive the leaflet (49 v 63, risk ratio 0.76, 95% confidence interval 0.59 to 0.97, P=0.04). Numbers reconsulting were similar (11 v 14). In group B, 44 patients took the antibiotics. CONCLUSION: Most previously well adults with acute bronchitis were judged not to need antibiotics. Reassuring these patients and sharing the uncertainty about prescribing in a information leaflet supported by verbal advice is a safe strategy and reduces antibiotic use.

Acute Disease↗

PubMed2002

Effect of computerised evidence based guidelines on management of asthma and angina in adults in primary care: cluster randomised controlled trial.

OBJECTIVE: To evaluate the use of a computerised support system for decision making for implementing evidence based clinical guidelines for the management of asthma and angina in adults in primary care. DESIGN: A before and after pragmatic cluster randomised controlled trial utilising a two by two incomplete block design. SETTING: 60 general practices in north east England. PARTICIPANTS: General practitioners and practice nurses in the study practices and their patients aged 18 or over with angina or asthma. MAIN OUTCOME MEASURES: Adherence to the guidelines, based on review of case notes and patient reported generic and condition specific outcome measures. RESULTS: The computerised decision support system had no significant effect on consultation rates, process of care measures (including prescribing), or any patient reported outcomes for either condition. Levels of use of the software were low. CONCLUSIONS: No effect was found of computerised evidence based guidelines on the management of asthma or angina in adults in primary care. This was probably due to low levels of use of the software, despite the system being optimised as far as was technically possible. Even if the technical problems of producing a system that fully supports the management of chronic disease were solved, there remains the challenge of integrating the systems into clinical encounters where busy practitioners manage patients with complex, multiple conditions.

Angina Pectoris↗

PubMed2003

Randomised controlled trial of treatment of unilateral visual impairment detected at preschool vision screening.

OBJECTIVES: To test the efficacy of treatment for unilateral visual loss detected by preschool vision screening and the extent to which effectiveness varies with initial severity. DESIGN: Randomised controlled trial of full treatment with glasses and patching, if required, compared with glasses only or no treatment. Masked assessment of best corrected acuity after one year of follow up. SETTING: Eight UK eye departments. PARTICIPANTS: 177 children aged 3-5 years with mild to moderate unilateral impairment of acuity (6/9 to 6/36) detected by screening. RESULTS: Children in the full and glasses treatment groups had incrementally better visual acuity at follow up than children who received no treatment, but the mean treatment effect between full and no treatment was equivalent to only one line on a Snellen chart (0.11 log units; 95% confidence interval 0.050 to 0.171; P < 0.0001). The effects of treatment depended on initial acuity: full treatment showed a substantial effect in the moderate acuity group (6/36 to 6/18 at recruitment) and no significant effect in the mild acuity group (6/9 to 6/12 at recruitment) (P = 0.006 for linear regression interaction term). For 64 children with moderate acuity loss the treatment effect was 0.20 log units, equivalent to one to two lines on a Snellen chart. When all children had received treatment, six months after the end of the trial, there was no significant difference in acuity between the groups. CONCLUSIONS: Treatment is worth while in children with the poorest acuity, but in children with mild (6/9 to 6/12) unilateral acuity loss there was little benefit. Delay in treatment until the age of 5 did not seem to influence effectiveness.

Amblyopia↗

PubMed2004

Effectiveness of community-based directly observed treatment for tuberculosis in an urban setting in Tanzania: a randomised controlled trial.

SETTING: An urban district in Dar es Salaam city with a high tuberculosis (TB) caseload. OBJECTIVE: To evaluate the effectiveness of community-based direct observation of treatment (DOT) using guardians and former TB patients compared to hospital-based DOT in an urban setting in Tanzania. DESIGN: Unblinded randomised control trial conducted in five sites under operational conditions in Temeke district. No changes to existing treatment delivery were made other than randomisation. The main outcome measure was treatment success. Analysis was by intention to treat. FINDINGS: A total of 587 new tuberculosis patients were enrolled. Among enrolled patients, 260 were assigned to community-based DOT using guardians and former TB patients and 327 to health facility-based DOT. Both DOT options gave similar treatment outcomes. Treatment success rate among patients under community and health facility-based DOT were 85% and 83%, respectively (OR 1.17, 95%CI 0.75-1.83). CONCLUSION: Community-based DOT is as effective as health facility-based DOT and can achieve good treatment outcomes, even in countries with well functioning National Tuberculosis Programmes.

Adolescent↗

PubMed2003

Randomised controlled trial assessing the acceptability of GyneFix versus Gyne-T380S for emergency contraception.

OBJECTIVE: To assess insertion-linked pain and the short-term user-acceptability and safety of the GyneFix as compared with T-framed intrauterine devices (IUDs). DESIGN: A randomised controlled trial in an outpatient clinic setting. METHOD: Women requesting an IUD for emergency contraception (EC) were allocated to either the short-term arm (GyneFix versus Nova-T200, or the long-term arm (GyneFix versus Gyne-T380S, and then randomised within each group. Visual analogue scores were used to assess the women's perception of the pain associated with insertion, which was patient-blinded. Follow-up was double-blinded, at 6 weeks, with bleeding and pain recorded over this time. RESULTS: A total of 175 women received an IUD in the long-term arm. The short-term arm was discontinued due to low recruitment (17 women at 20 months) and therefore the results relate to the long-term arm only. Outcome was known in 98% of subjects. The actual insertion procedure was scored as more painful for the GyneFix, both by the women (p = 0.013) and the doctors making their assessment of the women's pain (p = 0.04). The women with GyneFix described less pain in the subsequent 30 days after insertion (p = 0.005). Only 13% of women with GyneFix requested removal as compared with 20% with Gyne-T380S, with the difference being attributed to removal due to pain. The bleeding pattern was similar for those using GyneFix and Gyne-T380S. CONCLUSIONS: Our study suggests that although the actual fitting may be more painful, pain is less during the 6 weeks after insertion of GyneFix and fewer women discontinue its use because of pain, as compared with Gyne-T380S. The high overall continuation rate of all emergency IUDs at 6 weeks and low morbidity seen in this study favours more frequent IUD insertion where unprotected intercourse has occurred, given also its higher efficacy over oral hormonal EC.

Adolescent↗

PubMed2003

The FIP study: a randomised, controlled trial of screening and recognition of psychiatric disorders.

BACKGROUND: Research on questionnaires as screening tools for psychiatric disorders has yielded conflicting results. AIM: To examine the effect of a routinely administered questionnaire on recognition of common psychiatric disorders in general practice. DESIGN OF STUDY: Randomised controlled trial. SETTING: Twenty-eight general practices in Aarhus County, Denmark. METHOD: Thirty-eight general practitioners (GPs) and 1785 consecutive patients, aged 18-65 years old, presenting with a new health problem, participated. Before consultation, patients were screened using a brief screening questionnaire (SQ) including somatisation, anxiety, depression, and alcohol abuse scales. Patients were randomised to one of two groups: 900 questionnaires were disclosed and scored by the GPs, 885 were blinded. A stratified subsample of 701 patients was interviewed after the consultation using a standardised psychiatric research interview (SCAN). RESULTS: Overall the GPs' recognition rates were 14% (95% confidence interval [CI] = -2 to 30) better for depression and 35% (95% CI = 2 to 68) better for alcohol problems when SQs were disclosed. Recognition rates for anxiety improved 8% (95% CI = -9 to 26) overall. In the case of somatoform disorders, disclosure showed no effect overall. Among those with high SQ scores, however, disclosure increased recognition rates on any mental disorder evaluated. CONCLUSION: This study demonstrated limited usefulness for routine screening for common psychiatric disorders. However, findings suggest that the SQ may be useful for case-finding among a subgroup of patients with high SQ scores.

Adolescent↗

PubMed1998

Effect of varying the time frame for COOP-WONCA functional health status charts: a nested randomised controlled trial in Bristol, UK.

STUDY OBJECTIVES: To investigate whether changing the stated time frame for COOP-WONCA charts has any effect on responses. Specifically, to assess the effect of attempting to avoid the situation where the time frame crosses the onset of an acute episode. DESIGN: A randomised controlled trial of two time frames, nested within a main trial comparing early discharge with a hospital at home scheme against routine discharge policy. The time frames compared were the standard two weeks (four for the pain chart) and a shorter period of 48 hours for all seven charts. SETTING: Acute hospital wards in Frenchay Healthcare Trust and the Avon Orthopaedic Centre in Bristol. PARTICIPANTS: Patients entered into the main trial, who were medically stable, in need of continued rehabilitative care but suitable for discharge to hospital at home. MAIN RESULTS: A total of 200 patients were randomised, 106 to the shorter time frame, 94 to the standard charts. No clear differences were observed between the two groups for the proportion failing to self complete the charts. For the (seven) chart scores, only pain was statistically significantly different between the time frames (Mann-Whitney p = 0.0085; proportion reporting moderate or severe pain 19% higher in the standard group, 95% confidence intervals 5% to 33%). For both this chart and that for change in health, however, there was evidence of greater differences between the versions of the chart among those admitted more recently (p values for relevant interactions 0.004 and < or = 0.001 respectively). CONCLUSIONS: While the present findings give some support for the wide applicability of the standard version, there is sufficient evidence here to indicate that the time frame may influence the results, particularly for patients with a recent acute episode. In the absence of further data, then, it would seem prudent to consider a shorter time frame for such patients, especially if the aim is to assess current health status or to measure changes over a comparatively short period of time, or both.

Activities of Daily Living↗

PubMed2004

Randomised controlled trial of long term portographic follow up versus variceal band ligation following transjugular intrahepatic portosystemic stent shunt for preventing oesophageal variceal rebleeding.

BACKGROUND/AIMS: Transjugular intrahepatic portosystemic stent shunt (TIPSS) is effective in the prevention of variceal rebleeding but requires invasive portographic follow up. This randomised controlled trial aims to test the hypothesis that combining variceal band ligation (VBL) with TIPSS can obviate the need for long term TIPSS surveillance without compromising clinical efficacy, and can reduce the incidence of hepatic encephalopathy. PATIENTS/METHODS: Patients who required TIPSS for the prevention of oesophageal variceal rebleeding were randomised to either TIPSS alone (n = 39, group 1) or TIPSS plus VBL (n = 40, group 2). In group 1, patients underwent long term TIPSS angiographic surveillance. In group 2, patients entered a banding programme with TIPSS surveillance only continued for up to one year. RESULTS: There was a tendency to higher variceal rebleeding in group 2 although this did not reach statistical significance (8% v 15%; relative hazard 0.58; 95% confidence interval (CI) 0.15-2.33; p = 0.440). Mortality (47% v 40%; relative hazard 1.31; 95% CI 0.66-2.61; p = 0.434) was similar in the two groups. Hepatic encephalopathy was significantly less in group 2 (20% v 39%; relative hazard 2.63; 95% CI 1.11-6.25; p = 0.023). Hepatic encephalopathy was not statistically different after correcting for sex and portal pressure gradient (p = 0.136). CONCLUSIONS: TIPSS plus VBL without long term surveillance is effective in preventing oesophageal variceal rebleeding, and has the potential for low rates of encephalopathy. Therefore, VBL with short term TIPSS surveillance is a suitable alternative to long term TIPSS surveillance in the prevention of oesophageal variceal rebleeding.

Adult↗