Quality of reporting of clinical trials of dogs and cats and associations with treatment effects.

BACKGROUND: To address concerns about the quality of reporting of randomized controlled trials, and the potential for biased treatment effects in poorly reported trials, medical journals have adopted a common set of reporting guidelines, the Consolidated Standards of Reporting Trials (CONSORT) statement, to improve the reporting of randomized controlled trials. HYPOTHESIS: The reporting of clinical trials involving dogs and cats might not be ideal, and this might be associated with biased treatment effects. ANIMALS: Dogs and cats used in 100 randomly selected reports of clinical trials. METHODS: Data related to methodological quality and completeness of reporting were extracted from each trial. Associations between reporting of trial features and the proportion of positive treatment effects within trials were evaluated by generalized linear models. RESULTS: There were substantive deficiencies in reporting of key trial features. An increased proportion of positive treatment effects within a trial was associated with not reporting: the method used to generate the random allocation sequence (P < .001), the use of double blinding (P < .001), the inclusion criteria for study subjects (P = .003), baseline differences between treatment groups (P = .006), the measurement used for all outcomes (P = .002), and possible study limitations (P = .03). CONCLUSIONS AND CLINICAL IMPORTANCE: Many clinical trials involving dogs and cats in the literature do not report details related to methodological quality and aspects necessary to evaluate external validity. There is some evidence that these deficiencies are associated with treatment effects. There is a need to improve reporting of clinical trials, and guidelines, such as the CONSORT statement, can provide a valuable tool for meeting this need.

Methodological quality and completeness of reporting in clinical trials conducted in livestock species.

Randomized controlled trials (RCTs) are the gold standard for evaluating efficacy of treatments under real world conditions and, as such, it is important that they are conducted with methodological rigour to prevent biased results. Many medical journals have adopted a standard checklist for reporting of RCTs, the CONSORT statement. The objective of this study was to evaluate clinical trials in livestock populations to assess methodological quality and completeness of reporting and to investigate the association between these criteria and treatment effects. A total of 100 clinical trials published between 2006 and 2008 in the English language were randomly selected. For each trial, 2 reviewers independently completed a checklist based on the CONSORT statement and a different 2 reviewers completed a standard template describing the outcomes used and the statistical significance of all reported treatment effects. Disagreements among reviewers were resolved by consensus. The results showed that there were substantive deficiencies in the reporting of many of trial features, both related to methodological quality and completeness of reporting. Details on key features such as randomization, double blinding, and the number of subjects lost to follow-up were reported in only 67, 4, and 62% of trials, respectively. Reporting of random allocation to treatment group was associated with a lower proportion of positive treatments effects within trials, as was reporting of inclusion/exclusion criteria for study subjects, details on the intervention, animal signalment, significance tests of baseline differences for at least one variable, and the methods used to measure all outcomes. The results suggest that there are deficiencies in the current reporting of important features of RCTs conducted in livestock species and that these deficiencies may be associated with biased treatment effects. The creation and adoption of standards for trial reporting in livestock could aid authors, reviewers, and editors in ensuring that necessary trial details are reported in all published trials.

GAMIAN-Europe/BEAM survey II: cross-national analysis of unemployment, family history, treatment satisfaction and impact of the bipolar disorder on life style.

OBJECTIVES: In a previous report, we described the global analysis of the 'GAMIAN-Europe/BEAM survey' carried out in order to gain a better understanding of what is like to live with a bipolar disorder (BD). We report here on a cross-national analysis of unemployment, family history, side effects, treatment satisfaction and the impact the disorder had and has on patients' perception of life style and quality of life. METHODS: The methodology has been described in the previous report [Morselli PL and Elgie R, J Bipolar Disord (2003) 5, 265]. The analysis was carried out on the data derived from eight countries (France, Italy, Holland, Portugal, Russia, Scotland, Spain and Sweden) on a total of 968 respondents. Data from three other countries were not evaluated because of the low number of respondents. RESULTS: The data suggest that the problems and difficulties encountered by bipolar patients are similar throughout the various European countries, regardless of the political, social or cultural settings. The disease leads to a very high rate of unemployment and has a significant negative impact on the perception of the quality of life, both within and outside the family. Data also indicate a high level of family history. Considering the many variables analysed in the different nations, trans-national differences are often present for a given specific issue. However, with regard to the core issues, no significantly different patterns appear to emerge for any given nation. The current attitude towards the disorder displays an increased insight about the condition on the part of patients. There is also a definite trend towards an improvement in their perception of the disease with an evident minor or reduced impact of the disorder on the life-style of patients. CONCLUSIONS: Globally, the data indicate that in all participating countries there has been, in recent years, a consistent improvement in the 'perceived quality of life' of the 'informed patient' with an increased insight into the condition and an enhanced rate of compliance. Nevertheless, a lot still needs to be done to markedly improve the 'social functioning' and the 'social integration' of those who suffer from BD. The data reported underline some of the issues that still represent a truly onerous burden for BD patients in whichever European country they may live.

The changing structure of nonmetropolitan migration in the American Deep South.

"The United States and other post-industrial societies have recently undergone a form of population deconcentration characterized as rural-urban 'population turnaround'. This phenomenon may be attributed to changes in internal migration patterns. Explanations for such changes frequently imply that they have been accompanied by changes in the structure, or determinants, of migration. This study examines that thesis for a specific region, the American Deep South, for the 1950-1978 time period." The results suggest "that a structural transformation has occurred. During the 1950s, a decade of heavy net emigration, nonmetropolitan migration patterns were closely linked to the patterning of sustenance activity and metropolitan accessibility. By the 1970s, such linkages had weakened considerably. But this structural transformation can be detected in some parts of the region in the 1960s. Elsewhere, it still had not occurred in the 1970s."

Considerations in early surgery on good-risk patients with ruptured intracranial aneurysms.

A retrospective analysis of 100 consecutive patients with proven ruptured intracranial aneurysms, classified as Botterell Grades I to III on admission, was carried out to evaluate the efficacy of early operation. Surgical and management mortality/morbidity rates were lower for cases in which a single hemorrhage was operated on within 48 hours than when surgery was delayed for 7 days or more. Surgical and management mortality/morbidity rates were worse in good-risk patients treated surgically between the 3rd and 7th days following a hemorrhage, reflecting the increased incidence of postoperative vasospasm and raised intracranial pressure encountered at surgery during this interval.

Carotid thromboendarterectomy: a reappraisal. Criteria for patient selection.

Thromboendarterectomy performed in 35 patients with symptoms distal and ipsilateral to an occluded internal carotid artery resulted in patency in 19 cases (53%). Two factors that influence successful operation are early intervention following occlusion and good collateral circulation. In only 12 patients (34%) could the interval from occlusion to surgery be confidently determined. Four of these vessels, occluded for up to 7 days (100%), and five of eight vessels (63%), occluded for up to 4 weeks, were reopended. In the remaining patients, where the duration of occlusion was indefinite, greater reliance was placed on the evaluation and grading of angiographic collateral supply distal to the occlusion. Patients with Grade 1 to 3 collateral supply should not be explored unless occlusion occurred very recently. Patients with Grades 4 and 5 collateral supply are considered for carotid exploration regardless of the duration of the occlusion, as an alternative to other methods of revascularization.

The results of surgical management of extracranial internal carotid artery occlusion and stenosis.

Vascular reconstruction was attempted in 109 patients with carotid artery occlusion or stenosis. The follow-up on those with restored or improved flow was as long as nine years (average: two and one-half years).Arteriographic demonstration of lesions is mandatory. Complications were reduced by pre-arteriographic administration of anticoagulants and retrograde brachial arteriographic techniques.Although patients with stenosis are the best candidates, an attempt to restore flow in occluded vessels is warranted in all patients, except those with advanced disease or those who are drowsy and hemiplegic. Flow was restored in two-thirds of those who underwent early operation (under three days) and in one-quarter of those undergoing late operation. Even late operation restored flow in five of nine patients who presented with transient ischemic attacks.IN COMPLETED STROKES, OPERATION SHOULD BE LIMITED TO PATIENTS WITH: (1) minor strokes, (2) extensive strokes of short duration, and (3) extensive strokes of longer duration but with a worth-while outlook.When flow was restored or improved, symptoms were arrested in 93% of patients with transient ischemia, and at follow-up this result was maintained in 86%. Symptoms were arrested in 83% of those with strokes in evolution, and this was maintained at follow-up.Reconstruction combined with anticoagulant therapy of limited duration appears to be the optimal method of treatment.