Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “Randomised controlled trials as topic”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 1,189 records · Page 66Linked to original sources
PubMed2004

[Effectiveness of an outpatient disease management programme for chronic heart insufficiency patients].

The effectivity of a disease management programme (DMP) for outpatients suffering from chronic heart insufficiency (CHI) in primary care is presented. The programme is predominantly based on a weekly telephone monitoring by a case manager using a standardised questionnaire that scores CHI-relevant information of the patient. If the score exceeds a predefined limit the patient's general practitioner is alarmed. An observational study including a total of 115 patients indicates a significant decline of the hospital admission rate (p < 0.0001), as the primary outcome measure, whereas the total length of hospitalization remained constant. The findings are compared with other studies' results and the aims of a randomised controlled trial on the efficacy of DMP on patients with chronic heart failure are discussed.

Aged↗
PubMed1979

Atropine versus glycopyrrolate. A study of intraocular pressure and pupil size in man.

Following control observations of intraocular pressure and pupil size, in doses suitable for pre-anaesthetic medication, glycopyrrolate (0.004 mg/kg) and atropine (0.01 mg/kg) were given intramuscularly to healthy volunteers in a randomised, cross-over fashion. No significant change in either intraocular pressure or pupil size was noted 45 min after drug administration.

Adult↗
PubMed1996

The prevention of post partum haemorrhage: optimising routine management of the third stage of labour.

This paper concerns itself with the use of oxytocic therapy as part of the routine management of the third stage of labour. It attempts to answer three different questions: (1) do oxytocics reduce the risk of post partum haemorrhage (PPH) when used during the routine management of the third stage of labour? (2) does the clinical package of active management reduce the risk of PPH (3) which is the best oxytocic to use during routine active management of the third stage? It attempts to answer these questions by presenting the evidence from formal meta-analytical reviews of the randomised controlled trials of the pertinent intervention and by presenting the results of the two trials that were undertaken as a result of the hypotheses which were generated from the formal reviews.

Australia↗
PubMed2000

Surgical treatment of intracerebral haemorrhage.

There is at present no clear indication for surgical removal of intracerebral haemorrhage (ICH) in the majority of patients. With deterioration from an initially good level of consciousness, many surgeons would agree that removal is life saving. The question is whether or not surgical removal of clot improves the ultimate outcome in patients who are stable or even improving. Improvement in function is based on the concept of a penumbra around an ICH. There is now mounting evidence that there is a penumbra of functionally impaired, but potentially reversible, neuronal injury surrounding a haematoma. A pro-active approach must, therefore, be maintained in the management of these patients to salvage as much of this brain as possible. Alert patients with small (< 2 cm) haematomas and moribund patients with extensive haemorrhage may not require surgical evacuation. Indications for clot removal in patients between these extremes are controversial. Current practice favours surgical intervention in the following situations: (i) superficial haemorrhage; (ii) clot volume between 20-80 ml; (iii) worsening neurological status; (iv) relatively young patients; (v) haemorrhage causing midline shift/raised ICP; and (vi) cerebellar haematomas > 3 cm or causing hydrocephalus. A large multicentre prospective randomised controlled trial (International Surgical Trial in Intracerebral Haemorrhage) is currently underway to determine if early clot evacuation will lead to a better neurological outcome in patients with spontaneous supratentorial, non-aneurysmal ICH.

Cerebral Hemorrhage↗
PubMed1982

Randomised clinical trial of levonantradol and chlorpromazine in the prevention of radiotherapy-induced vomiting.

Levonantradol is a cannabis derivative. Cannabinoid anti-emetics are being assessed in cancer chemotherapy but have been little used in radiotherapy to date. A pilot study and randomised trial compared the anti-emetic effect of a standard drug (Chlorpromazine 26 mg) with Levonantradol at two doses (0.5 and 0.75 mg) in patients receiving palliative single fraction radiotherapy to sites likely to cause nausea and vomiting. Most patients were out-patients. Both drugs were well tolerated. The frequency of vomiting was similar in all three groups in both the pilot study and randomised trial.

Adult↗
PubMed2005

Analgesic therapy in postherpetic neuralgia: a quantitative systematic review.

BACKGROUND: Postherpetic neuralgia (PHN) is a complication of acute herpes zoster, which is emerging as a preferred clinical trial model for chronic neuropathic pain. Although there are published meta-analyses of analgesic therapy in PHN, and neuropathic pain in general, the evidence base has been substantially enhanced by the recent publication of several major trials. Therefore, we have conducted a systematic review and meta-analysis for both efficacy and adverse events of analgesic therapy for PHN. METHODS AND FINDINGS: We systematically searched databases (MEDLINE 1966-2004, EMBASE 1988-2004, CINAHL 1982-2002, and PubMed [29 October 2004]) for trials of PHN. We also searched references of retrieved studies and review articles for further trials. We included trials that examined adult patients with PHN of greater duration than 3 mo, that were blinded, randomised, and had at least one measure of pain outcome. Dichotomous pain outcome data were extracted for 50% decrease in baseline pain using a hierarchy of pain/pain-relief measurement tools. Where available, dichotomous data were also collected for adverse events. Calculated estimates of efficacy included relative benefit and number needed to treat. Of 62 studies identified, 35 were randomised controlled trials. Of these, 31 were placebo controlled and suitable for meta-analysis, from which it was possible to extract dichotomous efficacy outcome data from 25. This meta-analysis revealed that there is evidence to support the use of the following orally administered therapies: tricyclic antidepressants, "strong" opioids, gabapentin, tramadol, and pregabalin. Topical therapies associated with efficacy were lidocaine 5% patch and capsaicin. Finally, a single study of spinal intrathecal administration of lidocaine and methyl prednisolone demonstrated efficacy, although this has yet to be replicated. Data suggest that the following therapies are not associated with efficacy in PHN: certain NMDA receptor antagonists (e.g., oral memantine, oral dextromethorphan, intravenous ketamine), codeine, ibuprofen, lorazepam, certain 5HT1 receptor agonists, and acyclovir. Topical administration of benzydamine, diclofenac/diethyl ether, and vincristine (iontophoresis) are similarly not associated with efficacy, nor are intrathecal administration of lidocaine alone or epidural administration of lidocaine and methylprednisolone, intravenous therapy with lidocaine, subcutaneous injection of Cronassial, or acupuncture. However, many of the trials that demonstrated a lack of efficacy represented comparatively low numbers of patient episodes or were single-dose studies, so it may be appropriate to regard such interventions as "not yet adequately tested" rather than demonstrating "no evidence of efficacy." Topical aspirin/diethyl ether has not been adequately tested. CONCLUSION: The evidence base supports the oral use of tricyclic antidepressants, certain opioids, and gabapentinoids in PHN. Topical therapy with lidocaine patches and capsaicin is similarly supported. Intrathecal administration of methylprednisolone appears to be associated with high efficacy, but its safety requires further evaluation.

Analgesics↗
PubMed2000

Bayesian methods in health technology assessment: a review.

BACKGROUND: Bayesian methods may be defined as the explicit quantitative use of external evidence in the design, monitoring, analysis, interpretation and reporting of a health technology assessment. In outline, the methods involve formal combination through the use of Bayes's theorem of: 1. a prior distribution or belief about the value of a quantity of interest (for example, a treatment effect) based on evidence not derived from the study under analysis, with 2. a summary of the information concerning the same quantity available from the data collected in the study (known as the likelihood), to yield 3. an updated or posterior distribution of the quantity of interest. These methods thus directly address the question of how new evidence should change what we currently believe. They extend naturally into making predictions, synthesising evidence from multiple sources, and designing studies: in addition, if we are willing to quantify the value of different consequences as a 'loss function', Bayesian methods extend into a full decision-theoretic approach to study design, monitoring and eventual policy decision-making. Nonetheless, Bayesian methods are a controversial topic in that they may involve the explicit use of subjective judgements in what is conventionally supposed to be a rigorous scientific exercise. OBJECTIVES: This report is intended to provide: 1. a brief review of the essential ideas of Bayesian analysis 2. a full structured review of applications of Bayesian methods to randomised controlled trials, observational studies, and the synthesis of evidence, in a form which should be reasonably straightforward to update 3. a critical commentary on similarities and differences between Bayesian and conventional approaches 4. criteria for assessing the reporting of a Bayesian analysis 5. a comprehensive list of published 'three-star' examples, in which a proper prior distribution has been used for the quantity of primary interest 6. tutorial case studies of a variety of types 7. recommendations on how Bayesian methods and approaches may be assimilated into health technology assessments in a variety of contexts and by a variety of participants in the research process. METHODS: The BIDS ISI database was searched using the terms 'Bayes' or 'Bayesian'. This yielded almost 4000 papers published in the period 1990-98. All resultant abstracts were reviewed for relevance to health technology assessment; about 250 were so identified, and used as the basis for forward and backward searches. In addition EMBASE and MEDLINE databases were searched, along with websites of prominent authors, and available personal collections of references, finally yielding nearly 500 relevant references. A comprehensive review of all references describing use of 'proper' Bayesian methods in health technology assessment (those which update an informative prior distribution through the use of Bayes's theorem) has been attempted, and around 30 such papers are reported in structured form. There has been very limited use of proper Bayesian methods in practice, and relevant studies appear to be relatively easily identified. RESULTS: Bayesian methods in the health technology assessment context 1. Different contexts may demand different statistical approaches. Prior opinions are most valuable when the assessment forms part of a series of similar studies. A decision-theoretic approach may be appropriate where the consequences of a study are reasonably predictable. 2. The prior distribution is important and not unique, and so a range of options should be examined in a sensitivity analysis. Bayesian methods are best seen as a transformation from initial to final opinion, rather than providing a single 'correct' inference. 3. The use of a prior is based on judgement, and hence a degree of subjectivity cannot be avoided. However, subjective priors tend to show predictable biases, and archetypal priors may be useful for identifying a reasonable range of prior opinion.

Bayes Theorem↗
PubMed1998

The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions.

OBJECTIVE: To test the feasibility of creating a valid and reliable checklist with the following features: appropriate for assessing both randomised and non-randomised studies; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting, internal validity (bias and confounding) and power, but also for external validity. DESIGN: A pilot version was first developed, based on epidemiological principles, reviews, and existing checklists for randomised studies. Face and content validity were assessed by three experienced reviewers and reliability was determined using two raters assessing 10 randomised and 10 non-randomised studies. Using different raters, the checklist was revised and tested for internal consistency (Kuder-Richardson 20), test-retest and inter-rater reliability (Spearman correlation coefficient and sign rank test; kappa statistics), criterion validity, and respondent burden. MAIN RESULTS: The performance of the checklist improved considerably after revision of a pilot version. The Quality Index had high internal consistency (KR-20: 0.89) as did the subscales apart from external validity (KR-20: 0.54). Test-retest (r 0.88) and inter-rater (r 0.75) reliability of the Quality Index were good. Reliability of the subscales varied from good (bias) to poor (external validity). The Quality Index correlated highly with an existing, established instrument for assessing randomised studies (r 0.90). There was little difference between its performance with non-randomised and with randomised studies. Raters took about 20 minutes to assess each paper (range 10 to 45 minutes). CONCLUSIONS: This study has shown that it is feasible to develop a checklist that can be used to assess the methodological quality not only of randomised controlled trials but also non-randomised studies. It has also shown that it is possible to produce a checklist that provides a profile of the paper, alerting reviewers to its particular methodological strengths and weaknesses. Further work is required to improve the checklist and the training of raters in the assessment of external validity.

Bias↗
PubMed1997

[Randomized clinical trials in the Ugeskrift for Laeger 1948-1995].

The Danish Medical Journal (Ugeskrift for Laeger) was handsearched for randomised and pseudorandomised clinical trials over the years 1948-1995. We found 665 trials of which 539 (81%) were classified as randomised; the randomisation method was not stated for 422 of them (78%) and was insufficiently described in the majority of the rest. This problem became worse with time (p = 0.01). In contrast to the international literature where the increase was more gradual and occurred several years later, the number of randomised trials increased markedly around 1973. This change is associated with the introduction of courses in clinical research methodology during the previous years. Since randomisation is the most important safeguard against bias, the method should be described in detail.

Clinical Trials as Topic↗
PubMed1997

Topical ketorolac 0.5% solution for the treatment of vernal keratoconjunctivitis.

The efficacy of topical ketorolac 0.5% in treatment of vernal keratoconjunctivitis (VKC) was evaluated in a randomised double-blind prospective trial in 21 patients. Ketorolac treated eyes showed 50.7% reduction in main symptoms of itching compared to 33.3% relief in placebo treated eyes after 2 weeks of treatment (p < 0.01). Photophobia, ropy discharge, and conjunctival injection also lessened by 39.9%, 31.6%, and 39.1%, respectively, in ketorolac treated eyes compared to 23.8%, 17.3%, and 20.3% in placebo group. Transient stinging sensation was observed in 3 (14.3%) patients on ketorolac therapy. This study shows efficacy of ketorolac 0.5% solution in controlling symptoms in VKC.

Administration, Topical↗
PubMed1984

Randomised trial of chemo-endocrine therapy, endocrine therapy, and mastectomy alone in postmenopausal patients with operable breast cancer and axillary node metastasis.

Adjuvant therapy after total mastectomy and axillary clearance in postmenopausal women with breast cancer and axillary node metastasis was assessed; chemo-endocrine therapy (cyclophosphamide, methotrexate, fluorouracil, prednisone, and tamoxifen; CMFp + T) was compared with endocrine therapy (prednisone and tamoxifen; p + T), and with no adjuvant treatment in 463 patients aged less than or equal to 65 years. Endocrine therapy was compared with no adjuvant therapy in 320 patients aged 66-80 years. At median follow-up of 36 months, disease-free survival was significantly longer in CMFp + T patients than in p + T or control patients; p + T also significantly increased disease-free survival. There were no significant differences in overall survival between the randomised groups. In analyses of patterns of first failure, chemo-endocrine therapy reduced local, regional, and distant relapses, whereas endocrine therapy reduced local and regional recurrences only.

Aged↗
PubMed1982

[A new salt of erythromycin (A-137 or erythromycin lauryl sulfate) in the topical treatment of acne].

Thirty six patients affected of acne vulgaris, preferently inflammatory, graded from I to IV according to Plewig & Kligman scale, were included in a double blind trial of erythromycin laurilsulfate (A-137) alcoholic solution versus only the vehicle, both for topical. The solutions were assigned after randomisation and both groups were found to be statistically comparable in what concerned to age, sex and length of the disease and initial number of the different lesions. The treatment has been carried over 8 weeks, the solution was applied 3 times daily and controls were made fortnightly. It was assessed: a) Individual count of lesions existing in one side of the face; b) Grade of severity (I to IV); c) Frontal and lateral colour pictures; d) Overall opinion of patient. The statistical analysis of results shows significant differences between both groups in behalf of A-137 in the following parameters: number of closed comedones in the 2nd week (P less than 0,05), in closed comedones (P less than 0,05) and pustules (P less than 0,005) during the 4th week, in the number of pustules (P less than 0,025) during the 6th week and in closed comedones (P less than 0,05), papules (P less than 0,05) and pustules (P less than 0,0,25) at the end of the 8 weeks treatment. The severity grade was equally lower (P less than 0,025) in the A-137 group on the 8th week. There were no intolerance phenomena reported nor any kind of unwanted side effects during the study.

Acne Vulgaris↗
PubMed1981

A comparison between aerosol and inhaled powder administration of fenoterol in adult asthmatics.

Eleven adult asthmatics were given fenoterol either as a metered aerosol dose or as an inhaled powder with appropriate controls, in a randomised double-blind fashion. The increase in FEV1 was the same after both dosage forms and no side effects occurred indicating that powder inhalation is a safe and effective alternative to aerosol inhalation in the treatment of asthma with sympathomimetics.

Adolescent↗
PubMed2002

Association between competing interests and authors' conclusions: epidemiological study of randomised clinical trials published in the BMJ.

OBJECTIVE: To assess the association between competing interests and authors' conclusions in randomised clinical trials. DESIGN: Epidemiological study of randomised clinical trials published in the BMJ from January 1997 to June 2001. Financial competing interests were defined as funding by for profit organisations and other competing interests as personal, academic, or political. STUDIES: 159 trials from 12 medical specialties. MAIN OUTCOME MEASURES: Authors' conclusions defined as interpretation of extent to which overall results favoured experimental intervention. Conclusions appraised on 6 point scale; higher scores favour experimental intervention. RESULTS: Authors' conclusions were significantly more positive towards the experimental intervention in trials funded by for profit organisations alone compared with trials without competing interests (mean difference 0.48 (SE 0.13), P=0.014), trials funded by both for profit and non-profit organisations (0.30 (SE 0.10), P=0.003), and trials with other competing interests (0.45 (SE 0.13), P=0.006). Other competing interests and funding from both for profit and non-profit organisations were not significantly associated with authors' conclusions. The association between financial competing interests and authors' conclusions was not explained by methodological quality, statistical power, type of experimental intervention (pharmacological or non-pharmacological), type of control intervention (for example, placebo or active drug), or medical specialty. CONCLUSIONS: Authors' conclusions in randomised clinical trials significantly favoured experimental interventions if financial competing interests were declared. Other competing interests were not significantly associated with authors' conclusions.

Analysis of Variance↗
PubMed2006

[Interactions between radiation and hormonal therapy in breast cancer: simultaneous or sequential treatment].

BACKGROUND: Combining radiation and hormone therapy (administration of selective estrogen receptor modulators) has become common clinical practice in recent years for receptor positive breast cancer. Little is known about a possible interaction of both treatment modalities if they are given simultaneously. Tamoxifen (antiestrogen molecule, triphenylethylene derivative) may theoretically render cancer cells less responsive to radiotherapy arresting hormone-receptor-positive cells in G0/G1 phase and increase the risk of breast and lung fibrosis stimulating the secretion of transforming growth factor beta in human fibroblasts. PURPOSE: This article reviews the published data to assess the impact of sequencing of hormonal and radiation therapy on outcomes in breast cancer. METHODS: Computerised searches for publications debating the sequencing of hormonal therapy relative to radiation therapy were done using MEDLINE data. RESULTS: Results of tamoxifen experiments with cell culture regarding radioprotection of tumour clonogens are conflicting. In contrast to in vitro results, in animal studies no protective effect of tamoxifen was observed. In one in vitro study, letrozole (non-steroid selective aromatase inhibitor) had a radiosensitizing effect on breast-cancer lines. No randomised clinical trials to date have studied sequencing of tamoxifen or other selective estrogen receptor modulators and radiotherapy. Results from retrospective clinical studies which included treatment arms with and without tamoxifen showed reduction in tumour recurrence with tamoxifen. Some of these studies have noted increased risk of lung and breast fibrosis with tamoxifen with radiotherapy. Results of three articles examined the effect of tamoxifen sequence showed no adverse effect on local control or survival in sequential versus concurrent tamoxifen and radiation patients. One of the three studies also assessed the risk of complications with respect to the timing of tamoxifen with radiotherapy. There was no difference in the rates of complications between the two groups. The association of radiation and selective aromatase inhibitors or aromatase inactivators has not been addressed in clinical studies. CONCLUSIONS: Combined application of tamoxifen and radiotherapy improves survival and local control in breast cancer. Available clinical studies do not indicate that the simultaneous application of tamoxifen and radiotherapy is disadvantageous, as was suggested by some of the in vitro studies. The risk of subcutaneous breast and lung fibrosis might be slightly increased if tamoxifen is given simultaneously with radiotherapy. Both treatment modalities should be started early after surgery. There is no sufficient evidence to withhold tamoxifen administration during irradiation of breast cancer. The issue of optimal sequencing of hormonal and radiotherapy should be addressed in randomised clinical trials.

Animals↗