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Promotion of health and physical activity improves the mental health of elderly immigrants: results of a group randomised controlled trial among Turkish immigrants in the Netherlands aged 45 and over.

OBJECTIVES: Older immigrants from non-industrialised countries are a growing group, they have comparatively many health problems and are often hard to reach through health promotion and other preventive services. The aim of this study was to assess the effect of a short health education and physical exercise programme on the health and the physical activity of Turkish first generation elderly immigrants. DESIGN: Randomised controlled trial. SETTING: Welfare services in six Dutch cities. PARTICIPANTS: 126 people born in Turkey and aged 45 years and over, of whom 92 completed the trial. INTERVENTION: Eight, two hour sessions consisting of health education and exercises. Topics in health education focused on means to maintain a good health. Education was adapted to the culture and knowledge of older Turks and offered by a Turkish peer educator, in Turkish. MAIN OUTCOME MEASURES: Physical and mental wellbeing, and mental health based on the SF-12/36; knowledge on health and disease; physical activity. RESULTS: Participants were highly disadvantaged; 52% had not completed primary school and 49% had considerable problems in speaking Dutch. Participants in the intervention group showed an improvement in mental health (effect size: 0.38 SD (95% confidence intervals 0.03 to 0.73), p=0.03); the oldest subgroup also in mental wellbeing (effect size 0.75 SD (0.22 to 1.28), p=0.01). No improvements were seen in physical wellbeing and activity, nor in knowledge. CONCLUSIONS: Health education and physical exercise improve the mental state of deprived immigrants. Painstaking cultural adaptations to contents and method of delivery are essential to reach this effect.

Emigration and Immigration↗

Breast cancer screening: the effect of self selection for screening on comparisons of randomised controlled trials.

In randomised controlled trials of breast cancer screening women are randomly allocated to an intervention group that is offered screening, or a control group that receives the usual medical care. Not all women in the intervention group accept screening; the women who do so may differ from other women in their underlying risk of breast cancer. This self selection for screening can result in either women at high risk or at low risk being overrepresented in the screened group. When comparisons between trials are made it is important to take self selection for screening into account, as a trial with self selection of women at high risk has the potential to have greater efficacy than a trial with self selection of women at low risk. A method of adjusting for self selection when comparing randomised controlled trials of breast cancer screening is described.

Breast Neoplasms↗

Screening for hepatocellular carcinoma.

BACKGROUND AND AIM: The incidence of hepatocellular carcinoma is high among cirrhotic patients, ranging from 2 to 3% in western cohorts and 6-11% in eastern cohorts. Although only one randomised trial has been performed, clinical practice generally uses periodic screening to detect hepatocellular carcinoma in cirrhotic patients. We reviewed the scientific literature on hepatocellular carcinoma screening. MATERIALS AND METHODS: Evaluation of studies identified through MEDLINE and EMBASE (1990-May 2003). RESULTS: The available screening tests to detect hepatocellular carcinoma are alpha-fetoprotein (cut-off: 20 ng/ml) and ultrasound, which are generally combined. The reported sensitivity and specificity are 50-85% and 70-90%, respectively. An estimated doubling time of about 6 months has led to the use of an interval of 6 months between screenings. Based on the risk of hepatocellular carcinoma, cirrhotic patients are considered as the target population. Screening seems to detect smaller and more frequently unifocal hepatocellular carcinoma; the residual liver function is important for determining the eligibility for effective treatment (resection); hence the prevention is more effective for patients with well-compensated cirrhosis. The survival estimated by non-randomised studies is slightly longer for patients with screening-detected hepatocellular carcinoma, compared to those with clinically detected hepatocellular carcinoma, although few studies have accounted for 'lead time bias'. CONCLUSIONS: Although screening for the early detection of hepatocellular carcinoma has become quite common in clinical practice, its effectiveness remains controversial. Observational studies that have taken into account lead time bias suggest that survival is greater for patients with screening-detected hepatocellular carcinoma, yet the eligibility for effective treatments is low. Considering that only one randomised controlled trial has been conducted, it is crucial to standardise the screening schedule and to evaluate prevention programmes.

Carcinoma, Hepatocellular↗

Hit HIV-1 hard, but only when necessary.

Randomised, controlled trial data show that combination antiretroviral therapy for HIV-1 infection benefits people with CD4-cell counts less than 350 cells/microL. Based on currently known risks and benefits, we believe that if CD4-cell counts and viral load are monitored carefully, and highly active antiretroviral therapy (HAART) is started commonly when the CD4-cell count drops below 350 cells/microL, then clinically relevant immune-system damage and progression to AIDS and death can be greatly delayed or prevented. This approach is dictated by three features of HIV-1 infection that are not typical of infectious diseases: no available regimen can eradicate HIV-1; all currently effective regimens may cause undesirable, sometimes life-threatening, toxic effects; and, unless regimens are strictly adhered to, multidrug resistance can develop, limiting future treatment options. If therapy is started too early, cumulative side-effects of the drugs used and the development of multidrug resistance may outweigh the net benefits of the lengthening of life. If therapy is started too late, increases in disease progression and mortality outweigh the risk of adverse events. A patients' activist (MH) and a clinician (CCJC) discuss data that justify this balanced approach and the feasibility of randomised controlled trials to provide clearer answers about when to start treatment.

Anti-HIV Agents↗

Hormone replacement therapy: discrepancies between evidence and recommendations.

Postmenopausal hormone therapy is widely used to prevent diseases. This is not, however, based on the kind of evidence that is normally required of a preventive drug therapy: it is based on intermediary outcomes of trials and non-experimental studies. Many reasons can be postulated for the fact that we know little of this old and widely used therapy. To remedy the current situation, we should encourage randomised controlled trials, reveal the insufficiency of the current evidence, and challenge the drug industry's biased influence.

Aged↗

Improving prescribing of antihypertensive and cholesterol-lowering drugs: a method for identifying and addressing barriers to change.

BACKGROUND: We describe a simple approach we used to identify barriers and tailor an intervention to improve pharmacological management of hypertension and hypercholesterolaemia. We also report the results of a post hoc exercise and survey we carried out to evaluate our approach for identifying barriers and tailoring interventions. METHODS: We used structured reflection, searched for other relevant trials, surveyed general practitioners and talked with physicians during pilot testing of the intervention. The post hoc exercise was carried out as focus groups of international researchers in the field of quality improvement in health care. The post hoc survey was done by telephone interviews with physicians allocated to the experimental group of a randomised trial of our multifaceted intervention. RESULTS: A wide range of barriers was identified and several interventions were suggested through structured reflection. The survey led to some adjustments. Studying other trials and pilot testing did not lead to changes in the design of the intervention. Neither the post hoc focus groups nor the post hoc survey revealed important barriers or interventions that we had not considered or included in our tailored intervention. CONCLUSIONS: A simple approach to identifying barriers to change appears to have been adequate and efficient. However, we do not know for certain what we would have gained by using more comprehensive methods and we do not know whether the resulting intervention would have been more effective if we had used other methods. The effectiveness of our multifaceted intervention is under evaluation in a randomised controlled trial.

Anticholesteremic Agents↗

Pharmacological strategies to decrease transfusion requirements in patients undergoing surgery.

Surgical procedures are inevitably associated with bleeding. The amount of blood loss may vary widely between different surgical procedures and depends on surgical as well as non-surgical factors. Whereas adequate surgical haemostasis may suffice in most patients, pro-haemostatic pharmacological agents may be of additional benefit in patients with (diffuse) surgical bleeding or in patients with a specific underlying haemostatic defect. In general, surgical haemostasis and pharmacological therapies can be complementary in controlling blood loss. The use of pharmacological therapies to reduce blood loss and blood transfusions in surgery has historically been restricted to a few drugs. Antifibrinolytic agents (aprotinin, tranexamic acid and aminocaproic acid) have the best evidence supporting their use, especially in cardiac surgery, liver transplantation and some orthopaedic surgical procedures. Meta-analyses of randomised, controlled trials in cardiac patients have suggested a slight benefit of aprotinin, compared with the other antifibrinolytics. Desmopressin is the treatment of choice in patients with mild haemophilia A and von Willebrand disease. It has also been shown to be effective in patients undergoing cardiac surgery who received aspirin up to the time of operation. However, overall evidence does not support a beneficial effect of desmopressin in patients without pre-existing coagulopathy undergoing elective surgical procedures. Topical agents, such as fibrin sealants have been successfully used in a variety of surgical procedures. However, only very few controlled clinical trials have been performed and scientific evidence supporting their use is still limited. Novel drugs, like recombinant factor VIIa (eptacog alfa), are currently under clinical investigation. Recombinant factor VIIa has been introduced for the treatment of haemophilia patients with inhibitors, either in surgical or non-surgical situations. Preliminary data indicate that it may also be effective in surgical patients without pre-existing coagulation abnormalities. More clinical trials are warranted before definitive conclusions can be drawn about the safety and the exact role of this new drug in surgical patients. Only adequately powered and properly designed randomised, clinical trials will allow us to define the most effective and the safest pharmacological therapies for reducing blood loss and transfusion requirements in surgical patients. Future trials should also consider cost-effectiveness because of considerable differences in the costs of the available pro-haemostatic pharmacological agents.

Administration, Topical↗

Antibiotics for preventing respiratory tract infections in adults receiving intensive care.

OBJECTIVES: Pneumonia is an important cause of mortality in intensive care units. The objective of this review was to assess the effects of antibiotics for preventing respiratory tract infections and overall mortality in adults receiving intensive care. SEARCH STRATEGY: We searched MEDLINE, proceedings of scientific meetings and reference lists of articles from January 1984 to September 1997. We also contacted investigators in the field. SELECTION CRITERIA: Randomised trials of antibiotic prophylaxis for respiratory tract infections and deaths among adult intensive care unit patients. DATA COLLECTION AND ANALYSIS: Trials were assessed for quality and investigators contacted for additional information. MAIN RESULTS: Overall 33 trials involving 5727 people were included. There was variation in the antibiotics used, patient characteristics and the risk of respiratory tract infections and mortality in the control groups. In 16 trials (involving 3493 patients) of a topical and systemic antibiotic combination, the average rates of respiratory tract infections and deaths in the control group were 33% and 28% respectively. There was a significant reduction of both respiratory tract infections (odds ratio 0.36, 95% confidence interval 0.30 to 0. 43) and total mortality (odds ratio 0.80, 95% confidence interval 0. 68 to 0.93). On average five patients needed to be treated to prevent one infection and 23 treated to prevent one death. In 17 trials (involving 2366 patients) of topical antimicrobials the rates of respiratory tract infections and deaths in the control groups were 30% and 24% respectively. There was a significant reduction of respiratory tract infections (odds ratio 0.57, 95% confidence interval 0.46 to 0.69) but not in total mortality (odds ratio 1.01, 95% confidence interval 0.84 to 1.22). REVIEWER'S CONCLUSIONS: A combination of topical and systemic prophylactic antibiotics can reduce respiratory tract infections and overall mortality in adult patients receiving intensive care. [This abstract has been prepared centrally.]

Adult↗

Patient preferences in randomised trials: threat or opportunity?

OBJECTIVES: To assess whether it is feasible to elicit patients' preferences for treatments and then to proceed with randomisation which may allocate those with preferences to their less preferred treatment; and to describe which prognostic variables were associated with such preferences within the context of a randomised trial of an exercise programme for back pain. METHODS: The first 97 patients enrolled in a randomised controlled trial (RCT) for the treatment of back pain were asked about their preferences, health characteristics and other prognostic variables. RESULTS: Fifty-eight (60%) patients preferred to be allocated to the exercise programme whilst 38 (39%) were indifferent; one patient preferred conventional general practitioner (GP) management. No patient refused randomisation. Comparing patients preferring the exercise programme with indifferent patients showed that the former had a higher belief in the effectiveness of the new treatment (P < 0.01), tended to have worse back pain (P = 0.09), had back pain for a shorter duration (P = 0.04), and tended to have had more GP home visits (P = 0.06). CONCLUSIONS: For many randomised trials preference may be an important prognostic variable. In such circumstances, preference should be taken into account in the final analysis. This study demonstrates it is sometimes feasible to randomise patients to their less preferred treatment, thus allowing more robust statistical comparisons between randomised groups. This modification may make RCTs more rigorous and improve their external validity.

Adult↗