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At least 757 records · Page 42Linked to original sources
PubMed1996

Equipoise as a means of managing uncertainty: personal, communal and proxy.

Equipoise is advocated as a means of achieving high scientific and ethical standards in randomised trials. As used in the context of research the word describes a state of uncertainty characterised by the belief that in a trial no arm is known to offer greater harm or benefit than any other arm. Clinicians who lack personal equipoise are advised to accept clinical or communal equipoise, based on current unresolved disagreement among the medical profession. Equipoise is mainly discussed in the literature as an issue for senior doctors and research directors. Limitations of professional equipoise are reviewed, and data on the neglected topic of patients' equipoise are reported using the example of breast cancer trials. In theory, a patient who gives informed and voluntary consent to enter a randomised trial has achieved the equilibrium of equipoise. In practice, equipoise among patients ranges from personal to proxy acceptance.

Adult↗
PubMed2006

Meeting the information needs of women with breast cancer: Piloting a nurse-led intervention.

This study evaluated a telephone intervention, administered by specialist breast care nurses, that aimed to meet the information needs of women with breast cancer. The intervention was developed from previous work that examined priority information needs. Participants were allocated to a telephone intervention (n = 67) or control group (n = 68). Data were collected by means of semi-structured interviews with participants at two time points (3 months and 8-12 months post-diagnosis) and focused on patient satisfaction with sources of information, information needs and psychological morbidity. Interviews were also conducted with breast care nurses to ascertain their views on administering the intervention. The intervention group reported fewer physical problems at Time 2 and were more likely to have had their information needs met than women in the control group. The control group were more likely to utilise media sources of information at Time 2 whereas women in the intervention group reported breast care nurses as their most prominent source of information. There were no significant differences in psychological morbidity between the two study groups. The findings indicate that the intervention is a feasible and acceptable approach to meeting the information needs of women with breast cancer. Further research is required to evaluate the intervention in a randomised controlled trial.

Adult↗
PubMed2006

Sodium channel blockers for cystic fibrosis.

BACKGROUND: People with cystic fibrosis (CF) have increased transport of the salt, sodium across their airway lining. Over-absorption of sodium results in the dehydration of the liquid that lines the airway surface and is a primary defect in people with CF. OBJECTIVES: To determine whether the topical administration of drugs that block sodium transport improves the respiratory condition of people with CF. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches, handsearching relevant journals and abstract books of conference proceedings. We contacted principal investigators known to work in the field, previous authors and pharmaceutical companies who manufacture ion transport agents for unpublished or follow-up data. Most recent search of the Group's register: March 2006 SELECTION CRITERIA: Published or unpublished randomised controlled trials (RCTs) or quasi-randomised controlled trials of sodium channel blockers compared to placebo or another sodium channel blocker or the same sodium channel blocker at a different dosing regimen. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data. Meta-analysis was limited due to differing study designs. MAIN RESULTS: Four RCTs, with a total of 205 participants, examining the topical administration of the short-acting sodium channel blocker, amiloride, compared to placebo were identified as eligible for inclusion in the review. For three studies, interventions for six months were completed and it was possible to calculate relative change in respiratory function (FVC). There was a significant difference found in relative change in FVC in favour of placebo (GIV analysis of weighted mean difference for FVC; 1.51% (95% confidence interval -2.77 to -0.25). There were no significant differences identified in other clinically relevant outcomes. AUTHORS' CONCLUSIONS: We found no evidence that the topical administration of a short-acting sodium channel blocker improves respiratory condition in people with cystic fibrosis and some limited evidence of deterioration in lung function.

Cystic Fibrosis↗
PubMed2005

Aloe vera for preventing radiation-induced skin reactions: a systematic literature review.

AIM: To systematically review and critically appraise the evidence for effectiveness of Aloe vera gel for radiation-induced skin reactions. MATERIALS AND METHODS: Major biomedical databases and specialist complementary and alternative medicine databases were searched. Additionally, efforts were made to identify unpublished and ongoing research. Relevant research was systematically categorised by study type and appraised according to study design. Clinical commentaries were obtained for each study included in the review. RESULTS: One earlier systematic review on Aloe vera for a variety of conditions was located. Five published randomised-controlled trials (RCTs) were found, along with two additional RCTs that are not published. No non-RCTs, uncontrolled studies or qualitative studies were found. CONCLUSIONS: There is no evidence from clinical trials to suggest that topical Aloe vera is effective in preventing or minimising radiation-induced skin reactions in cancer patients. Further methodologically rigorous, sufficiently powered research studies should be conducted to evaluate the effectiveness of currently used and novel therapies for the prevention, minimisation and management of radiation-induced skin reactions.

Aloe↗
PubMed2000

[Is an article worthy to be read? Practical guide to the art of critical assessment of a randomized controlled trial].

Clinicians need to know how to critically appraise clinical trials in order to choose the best papers upon which to base their clinical decisions. By appraising the section on "methods" the most important questions regarding validity and relevance can be answered. The most important components of validity include adequate randomisation procedures, blinding (where possible) and minimising the number of patients lost to follow-up. The conclusions of a well conducted study should be applicable to a broad range of patients and settings.

Data Interpretation, Statistical↗
PubMed2006

Topical analgesia for acute otitis media.

BACKGROUND: Acute otitis media (AOM) is a spontaneously remitting disease for which pain is the most distressing symptom. Antibiotics are now known to have less benefit than previously assumed. OBJECTIVES: To assess the effectiveness of topical analgesia for AOM. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2006), MEDLINE (1966 to May Week 3 2006), EMBASE (1990 to December 2005) and LILACS (1982 to September 2005) without language restriction, and the reference lists of articles. We also contacted manufacturers and authors. SELECTION CRITERIA: Double-blind randomised or quasi-randomised controlled trials comparing an otic preparation with an analgesic effect (excluding antibiotics) versus placebo or an otic preparation with an analgesic effect (excluding antibiotics) versus any other otic preparation with an analgesic effect, in adults or children presenting at primary care settings with AOM without perforation. DATA COLLECTION AND ANALYSIS: Potential studies were screened independently and trial quality was assessed by three authors, and differences were resolved by discussion. Data was then independently extracted from the trials selected by two authors. We contacted the authors of three trials to acquire additional information not available in published articles. MAIN RESULTS: Our searches yielded 356 records; four trials met our criteria. One trial with 54 participants compared treatment with anaesthetic ear drops versus an olive oil placebo immediately at diagnosis. All patients were also given paracetamol. There was a statistically significant pain reduction of 25% in those receiving anaesthetic drops 30 minutes after instillation. Three trials (with one common co-author) compared anaesthetic ear drops with naturopathic herbal ear drops in 274 patients. One of these trials also used antibiotics in both groups. There were statistically significant differences at instillation of drops, or 15 or 30 minutes after the instillation (or both) on one to three days after diagnosis, always favouring the naturopathic group in each trial. AUTHORS' CONCLUSIONS: The evidence from these four randomised controlled trials, only one of which addresses the most relevant question of primary effectiveness, is insufficient to know whether ear drops are effective or not.

Acute Disease↗
PubMed2006

Percutaneous needle aspiration, injection, and reaspiration with or without benzimidazole coverage for uncomplicated hepatic hydatid cysts.

BACKGROUND: Hepatic hydatid cyst is an important public health problem in parts of the world where dogs are used for cattle breeding. Management of uncomplicated hepatic hydatid cysts is currently surgical. However, the puncture, aspiration, injection, and re-aspiration (PAIR) method with or without benzimidazole coverage has appeared as an alternative to surgery over the past decade. OBJECTIVES: To assess the benefits and harms of PAIR with or without benzimidazole coverage for patients with uncomplicated hepatic hydatid cyst in comparison with sham/no intervention, surgery, or medical treatment. SEARCH STRATEGY: The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Controlled Trials Register in The Cochrane Library, MEDLINE, EMBASE, DARE, and ACP Journal Club and full text searches were combined (all searched October 2004). Reference lists of pertinent studies and other identified literature were scanned. Researchers in the field were contacted. SELECTION CRITERIA: Only randomised clinical trials using the PAIR method with or without benzimidazole coverage as the experimental treatment of uncomplicated hepatic hydatid cyst (ie, hepatic hydatid cysts which are not infected and do not have any communication with the biliary tree or other viscera) versus no intervention, sham puncture (ie, performing all steps for puncture, pretending that PAIR is being performed, but actually not performing the procedure proper), surgery, or chemotherapy were included. DATA COLLECTION AND ANALYSIS: Data were independently extracted and methodological quality of each trial was assessed by the authors. Principal authors of the trials were contacted to retrieve missing data. MAIN RESULTS: We found no randomised clinical trials comparing PAIR versus no or sham intervention. We identified only two randomised clinical trials, one comparing PAIR versus surgical treatment (n = 50) and the other comparing PAIR (with or without albendazole) versus albendazole alone (n = 30). Both trials were graded as 'adequate' for allocation concealment; however, generation of allocation sequence and blinding methods were 'unclear' in both of them. Compared to surgery, PAIR plus albendazole obtain similar cyst disappearance and mean cyst diameter with fewer adverse events (32% versus 84%, P < 0.001) and fewer days in hospital (mean + SD) ( 4.2 + 1.5 versus 12.7 + 6.5 days, P < 0.001). Compared to albendazole, PAIR with or without albendazole obtain significantly more often (P < 0.01) cyst reduction and symptomatic relief. AUTHORS' CONCLUSIONS: PAIR seems promising, but there is insufficient evidence to support or refute PAIR with or without benzimidazole coverage for treating patients with uncomplicated hepatic hydatid cyst. Further well-designed randomised clinical trials are necessary to address the topic.

Albendazole↗
PubMed2004

Interventions for impetigo.

BACKGROUND: Impetigo is a common superficial bacterial skin infection, most frequently encountered in children. There is no standard therapy and guidelines for treatment differ widely. Treatment options include many different oral and topical antibiotics as well as disinfectants. OBJECTIVES: To assess the effects of treatments for impetigo, including waiting for natural resolution. SEARCH STRATEGY: We searched the Skin Group Specialised Trials Register (March 2002), Cochrane Central Register of Controlled Trials (CENTRAL, Issue 1 2002), the National Research Register (2002), MEDLINE (from 1966 to January 2003), EMBASE (from 1980 to March 2000) and LILACS (November 2001). We handsearched the Yearbook of Dermatology (1938-1966), the Yearbook of Drug Therapy (1949-1966), used reference lists of articles and contacted pharmaceutical companies. SELECTION CRITERIA: Randomised controlled trials of treatments for non-bullous and bullous, primary and secondary impetigo. DATA COLLECTION AND ANALYSIS: All steps in data collection were done by two independent reviewers. We performed quality assessments and data collection in two separate stages. MAIN RESULTS: We included 57 trials including 3533 participants in total which studied 20 different oral and 18 different topical treatments. CURE OR IMPROVEMENT: Topical antibiotics showed better cure rates than placebo (pooled odds ratio (OR) 6.49, 95% confidence interval (CI) 3.93 to 10.73), and no topical antibiotic was superior (pooled OR of mupirocin versus fusidic acid 1.76, 95% CI 0.69 to 2.16). Topical mupirocin was superior to oral erythromycin (pooled OR 1.22, 95% CI 1.05 to 2.97). In most other comparisons, topical and oral antibiotics did not show significantly different cure rates, nor did most trials comparing oral antibiotics. Penicillin was inferior to erythromycin and cloxacillin and there is little evidence that using disinfectant solutions improves impetigo. SIDE EFFECTS: The reported number of side effects was low. Oral antibiotic treatment caused more side effects, especially gastrointestinal ones, than topical treatment. REVIEWERS' CONCLUSIONS: Data on the natural course of impetigo are lacking. Placebo controlled trials are scarce. There is little evidence about the value of disinfecting measures. There is good evidence that topical mupirocin and topical fusidic acid are equally, or more effective than oral treatment for people with limited disease. It is unclear if oral antibiotics are superior to topical antibiotics for people with extensive impetigo. Fusidic acid and mupirocin are of similar efficacy. Penicillin was not as effective as most other antibiotics. Resistance patterns against antibiotics change and should be taken into account in the choice of therapy.

Administration, Oral↗