PubMed Health⌕ Search

Biomedical subjects

Jørgen Hilden

Publications and source records attributed to Jørgen Hilden.

At least 19 recordsLinked to original sources
PubMed2006

[Cochrane reviews compared with industry-supported and other meta-analyses of the same drugs--secondary publication].

24 Cochrane reviews were compared with other, closely matched, meta-analyses of the same drugs. The quality score was highest for Cochrane reviews (7 vs. 2, p < 0.01). Of 8 industry-supported reviews, 7 with conclusions all recommended the experimental drug without reservations, compared with none of the Cochrane reviews (p = 0.02) although the estimated treatment effect was similar on average (p = 0.64). Industry-supported reviews were less transparent, had few reservations about methodological limitations of the included trials, and should be read with caution.

English Abstract↗
PubMed2006

Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: systematic review.

OBJECTIVE: To compare the methodological quality and conclusions in Cochrane reviews with those in industry supported meta-analyses and other meta-analyses of the same drugs. DESIGN: Systematic review comparing pairs of meta-analyses that studied the same two drugs in the same disease and were published within two years of each other. DATA SOURCES: Cochrane Database of Systematic Reviews (2003, issue 1), PubMed, and Embase. DATA EXTRACTION: Two observers independently extracted data and used a validated scale to judge the methodological quality of the reviews. RESULTS: 175 of 1596 Cochrane reviews had a meta-analysis that compared two drugs. Twenty four meta-analyses that matched the Cochrane reviews were found: eight were industry supported, nine had undeclared support, and seven had no support or were supported by non-industry sources. On a 0-7 scale, the median quality score was 7 for Cochrane reviews and 3 for other reviews (P < 0.01). Compared with industry supported reviews and reviews with undeclared support, Cochrane reviews had more often considered the potential for bias in the review--for example, by describing the method of concealment of allocation and describing excluded patients or studies. The seven industry supported reviews that had conclusions recommended the experimental drug without reservations, compared with none of the Cochrane reviews (P = 0.02), although the estimated treatment effect was similar on average (z = 0.46, P = 0.64). Reviews with undeclared support and reviews with not for profit support or no support had conclusions that were similar in cautiousness to the Cochrane reviews. CONCLUSIONS: Industry supported reviews of drugs should be read with caution as they were less transparent, had few reservations about methodological limitations of the included trials, and had more favourable conclusions than the corresponding Cochrane reviews.

Bias↗
PubMed2006

Performance of clinical mammography: a nationwide study from Denmark.

Clinical mammography is the key tool for breast cancer diagnosis, but little is known about the impact of the organisational set-up on the performance. We evaluated whether organisational factors influence the performance of clinical mammography. Clinical mammography data from all clinics in Denmark in the year 2000 were collected and linked to cancer outcome. Use of the National Institute of Radiation Hygiene register for identification of radiology clinics ensured comprehensive nationwide registration. We used the final mammographic assessment at the end of the imaging work-up to determine sensitivity, specificity and accuracy, the latter using a receiver-operating characteristics (ROC) analysis. In 96,534 clinical mammography examinations, sensitivity was 75% and specificity 99%. The presence of at least one high volume-reading radiologist in the clinic increased accuracy (AUC = 0.91 for <1,000 examinations/year and 0.92 for >2,000 examinations/year, p = 0.017). The examination volume per clinic showed no clear effect on performance, as accuracy was significantly higher in clinics with a medium number of examinations (AUC = 0.93 for 2,000-4,000 examinations/year and 0.90 for >6,000 examinations/year, p = 0.003). Accuracy was significantly lower in regions with high annual utilisation rate of clinical mammography, which means the proportion of examined women in a region (AUC = 0.90 for 3.0-5.0% annual utilisation rate and AUC = 0.93 for 2.0-2.5% annual utilisation rate, and p = 0.001), indicating that clinical mammography worked best in patient populations of purely symptomatic women. Our data indicate that to increase the accuracy of clinical mammography at the community level, the presence of an experienced radiologist should be prioritized ahead of raising the clinic size.

Adult↗
PubMed2006

Effect of perioperative beta blockade in patients with diabetes undergoing major non-cardiac surgery: randomised placebo controlled, blinded multicentre trial.

OBJECTIVES: To evaluate the long term effects of perioperative beta blockade on mortality and cardiac morbidity in patients with diabetes undergoing major non-cardiac surgery. DESIGN: Randomised placebo controlled and blinded multicentre trial. Analyses were by intention to treat. SETTING: University anaesthesia and surgical centres and one coordinating centre. PARTICIPANTS: 921 patients aged > 39 scheduled for major non-cardiac surgery. INTERVENTIONS: 100 mg metoprolol controlled and extended release or placebo administered from the day before surgery to a maximum of eight perioperative days. MAIN OUTCOME MEASURES: The composite primary outcome measure was time to all cause mortality, acute myocardial infarction, unstable angina, or congestive heart failure. Secondary outcome measures were time to all cause mortality, cardiac mortality, and non-fatal cardiac morbidity. RESULTS: Mean duration of intervention was 4.6 days in the metoprolol group and 4.9 days in the placebo group. Metoprolol significantly reduced the mean heart rate by 11% (95% confidence interval 9% to 13%) and mean blood pressure by 3% (1% to 5%). The primary outcome occurred in 99 of 462 patients in the metoprolol group (21%) and 93 of 459 patients in the placebo group (20%) (hazard ratio 1.06, 0.80 to 1.41) during a median follow-up of 18 months (range 6-30). All cause mortality was 16% (74/462) in the metoprolol group and 16% (72/459) in the placebo group (1.03, 0.74 to 1.42). The difference in risk for the proportion of patients with serious adverse events was 2.4% (- 0.8% to 5.6%). CONCLUSIONS: Perioperative metoprolol did not significantly affect mortality and cardiac morbidity in these patients with diabetes. Confidence intervals, however, were wide, and the issue needs reassessment. TRIAL REGISTRATION: Current Controlled Trials ISRCTN58485613.

Adrenergic beta-Antagonists↗
PubMed2006

Recurrence of pulmonary vein conduction and atrial fibrillation after pulmonary vein isolation for atrial fibrillation: a randomized trial of the ostial versus the extraostial ablation strategy.

BACKGROUND: Both segmental ostial and circumferential extraostial pulmonary vein (PV) isolation have been proven effective in the treatment of atrial fibrillation (AF). However, the recurrence of AF and PV conduction after the 2 ablation strategies has never been compared in a randomized study. METHODS: A total of 100 consecutive patients (age 56 +/- 10; 71 men) with symptomatic AF (paroxysmal, 51; persistent, 49) were randomized to segmental ostial (n = 54) or circumferential extraostial (n = 46) PV isolation. A circular catheter positioned at the ostium of each target PV guided the ostial PV isolation. Extraostial PV isolation was performed by encircling the paired left and right PVs, respectively, guided by an electroanatomic mapping system. RESULTS: A total of 84% of the patients had recurrent AF after the first PV isolation procedure, showing 72% with AF and 12% with organized left atrial tachycardia. In patients undergoing reablation, all but 2 patients had recurrence of left atrium PV conduction (>95%). During a mean follow-up of 12 months without antiarrhythmic medication, 57% of patients who underwent extraostial PV isolation were free of arrhythmia symptoms compared with 31% of patients who underwent ostial PV isolation (P < .05). This difference in success rate between the 2 ablation strategies was mainly seen in patients known with persistent AF (52% and 15%, respectively; P = .02) as opposed to patients with paroxysmal AF (65% and 46%, respectively; P = .26). CONCLUSIONS: Overall, the more proximal, extraostial PV isolation was found to be superior to ostial PV isolation, especially in patients known with persistent AF. A high recurrence rate of 84% after a single complete PV isolation procedure was seen. At reablation, more than 95% had recurrence of left atrium PV conduction regardless of the procedure used, supporting the idea that complete PV isolation seems essential to prevent arrhythmia recurrences.

Aged↗
PubMed2006

Systematic re-examination of carriers of balanced reciprocal translocations: a strategy to search for candidate regions for common and complex diseases.

Balanced reciprocal translocations associated with genetic disorders have facilitated the identification of a variety of genes for early-onset monogenic disorders, but only rarely the genes associated with common and complex disorders. To assess the potential of chromosomal breakpoints associated with common/ complex disorders, we investigated the full spectrum of diseases in 731 carriers of balanced reciprocal translocations without known early-onset disorders in a nation-wide questionnaire-based re-examination. In 42 families, one of the breakpoints at the cytogenetic level concurred with known linkage data and/or the translocation co-segregated with the reported phenotype, for example, we found a significant linkage (lod score=2.1) of dyslexia and a co-segregating translocation with a breakpoint in a previously confirmed locus for dyslexia. Furthermore, we identified 441 instances of at least two unrelated carriers with concordant breakpoints and traits. If applied to other populations, re-examination of translocation carriers may identify additional genotype-phenotype associations, some of which may be novel and others that may coincide with and provide additional support of data presented here.

Age of Onset↗
PubMed2006

The influence of pregnancy on the development of autoimmunity in chronic lymphocytic leukemia.

To examine whether pregnancy influences the development of autoimmunity in chronic lymphocytic leukemia (CLL), we studied 591 consecutive CLL patients (202 post-menopausal women and 389 men). The mean observation time for all patients was 3.8 years, corresponding to approximately 2200 person-years of follow-up. Autoimmune manifestations were analyzed in 194 women with known obstetric history and known number of long-term sexual partners, and in the 389 male CLL patients for comparison. One hundred and fifty-nine of the CLL patients exhibited autoimmune manifestations, 38% in females and 21% in men. In female CLL patients, the frequency of autoimmunity and the number of pregnancies and the number of partners were strongly correlated. Each of the major autoimmune types approximately doubled in frequency for each additional pregnancy. The impact of pregnancy on expressed autoimmunity increased with each additional sexual partner (the odds of autoimmunity increased 11 times with each long-term sexual partner). The average numbers of pregnancies in female CLL patients with and without autoimmunity were 4.92 and 2.24, respectively (P < 0.001). Coombs' positive autoimmune anemia, a gastric ulcer with parietal cell autoantibodies and idiopathic thrombocytopenic purpura were equally common in women and men, whereas autoimmune thyroiditis, Sjögren's syndrome, rheumatoid arthritis and systemic lupus erythematosus were seen in higher rates in women than in men. The spectrum of autoimmunity suggests that pregnancy-related alloimmunization may be involved in the development of autoimmunity in CLL.

Autoantibodies↗
PubMed2005

Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial.

OBJECTIVE: To determine if the macrolide clarithromycin affects mortality and cardiovascular morbidity in patients with stable coronary heart disease. DESIGN: Centrally randomised multicentre trial. All parties at all stages were blinded. Analyses were by intention to treat. SETTING: Five Copenhagen University cardiology departments and a coordinating centre. PARTICIPANTS: 13,702 patients aged 18 to 85 years who had a discharge diagnosis of myocardial infarction or angina pectoris in 1993-9 and alive in August 1999 were invited by letter; 4373 were randomised. INTERVENTIONS: Two weeks' treatment with clarithromycin 500 mg/day or matching placebo. MAIN OUTCOME MEASURES PRIMARY OUTCOME: composite of all cause mortality, myocardial infarction, or unstable angina pectoris during three years' follow-up. Secondary outcome: composite of cardiovascular mortality, myocardial infarction, or unstable angina pectoris. The outcomes were obtained from Danish registers and were blindly assessed by the event committee. RESULTS: 2172 participants were randomised to clarithromycin and 2201 to placebo. We found no significant effects of clarithromycin on the primary outcome (hazard ratio 1.15, 95% confidence interval 0.99 to 1.34) or secondary outcome (1.17, 0.98 to 1.40). Mortality was significantly higher in the clarithromycin arm (1.27, 1.03 to 1.54; P = 0.03) as a result of significantly higher cardiovascular mortality (1.45, 1.09 to 1.92; P = 0.01). CONCLUSIONS: Short term clarithromycin in patients with stable coronary heart disease may cause significantly higher cardiovascular mortality. The long term safety of clarithromycin in patients with stable ischaemic heart disease should be examined. Trial registration ClinicalTrials.gov NCT00121550.

Adolescent↗
PubMed2005

[Measures for the performance of diagnostic tests].

Systematic reviews have revealed that the methodological quality of studies on diagnostic accuracy is mediocre. In addition, clinicians may experience difficulties in interpreting and using measures describing the accuracy of a test. Using the Ottawa Ankle Rule as an example, we review the measures commonly used to describe the accuracy of diagnostic tests. The performance of tests is often given in terms of sensitivity and specificity. However, these measures have no relevance to clinicians unless they can be converted into predictive values. We describe how to calculate the predictive values and how they can be determined using likelihood ratios and Fagan's nomogram. The reader is introduced to the critical appraisal of results based on studies of the accuracy of tests. We describe how both the clinical spectrum and the methodological quality can influence estimates of diagnostic accuracy and stress the inevitable uncertainty involved in extrapolating results from the literature to clinical practice. Methods of calculating the confidence intervals for estimates of accuracy are presented.

Ankle Injuries↗
PubMed2005

Increased resting heart rate following radiofrequency catheter ablation for atrial fibrillation.

AIM: Sinus tachycardia has been observed following radiofrequency (RF) catheter ablation for various kinds of supraventricular tachycardia. This study is aimed at determining the occurrence of changes in sinus-rhythm heart rate (HR) after pulmonary vein (PV) isolation in patients with paroxysmal/persistent atrial fibrillation (AF), prospectively. METHODS: Patients with a history of AF underwent segmental or circumferential isolation of the PVs. A total of 62 consecutive patients, mean age 55 +/- 10, was included. Clinical evaluation was performed before and one, three, six, nine, and 12 months following the procedure. RESULTS: Following PV isolation, the mean HR significantly increased from 58 +/- 10 bpm at baseline to 67 +/- 12 bpm at one month, 71 +/- 13 bpm at three months, 69 +/- 12 bpm at six months, 69 +/- 13 at nine months, and 70 +/- 13 at 12 months follow-up. The ablation success significantly correlated with the increase in HR at one month follow-up. In three patients the mean HR increased > 25 bpm resulting in symptoms necessitating therapy with rate-controlling drugs. CONCLUSION: PV isolation in patients with AF may result in increased HR, which positively correlated with the ablation success. This change does not seem to resolve spontaneously after a follow-up of 12 months. Approximately 5% of patients may develop symptoms due to an increased HR, necessitating treatment with rate-controlling drugs.

Atrial Fibrillation↗
PubMed2004

Should CA-125 response criteria be preferred to response evaluation criteria in solid tumors (RECIST) for prognostication during second-line chemotherapy of ovarian carcinoma?

PURPOSE: The aim of the study was to compare the prognostic value of a response by the Gynecologic Cancer Intergroup (GCIG) Cancer Antigen (CA) -125 response criteria and the Response Evaluation Criteria in Solid Tumors (RECIST) on survival in patients with ovarian carcinoma receiving second-line chemotherapy. PATIENTS AND METHODS: From a single-institution registry of 527 consecutive patients with primary ovarian carcinoma, 131 records satisfied the inclusion criteria: ovarian carcinoma of International Federation of Gynecology and Obstetrics stage IC to IV, first-line chemotherapy with paclitaxel and a platinum compound, refractory or recurrent disease, and second-line chemotherapy consisting of topotecan or paclitaxel plus carboplatin. Univariate and multivariate analyses of survival were performed using the landmark method. RESULTS: In patients with measurable disease by RECIST and with assessable disease by the CA-125 criteria (n = 68), the CA-125 criteria were 2.6 times better than the RECIST at disclosing survival. In a multivariate Cox analysis with inclusion of nine potential prognostic parameters, CA-125 response (responders v nonresponders; hazard ratio, 0.21; P < .001) and number of relapse sites (solitary v multiple; hazard ratio, 0.47; P = .020) were identified as contributory prognostic factors for survival, whereas the parameters of RECIST (responders v nonresponders), as well as the remaining variables, had nonsignificant prognostic impact. CONCLUSION: The GCIG CA-125 response criteria are a better prognostic tool than RECIST in second-line treatment with topotecan or paclitaxel plus carboplatin in patients with ovarian carcinoma.

Aged↗
PubMed2003

Measurement of quality of life I. A methodological framework.

Despite the widespread acceptance of quality of life (QOL) as the ideal guideline in healthcare and clinical research, serious conceptual and methodological problems continue to plague this area. In an attempt to remedy this situation, we propose seven criteria that a quality-of-life concept must meet to provide a sound basis for investigation by questionnaire. The seven criteria or desiderata are: (1) an explicit definition of quality of life; (2) a coherent philosophy of human life from which the definition is derived; (3) a theory that operationalizes the philosophy by specifying unambiguous, nonoverlapping, and jointly exhaustive questionnaire items; (4) response alternatives that permit a fraction-scale interpretation; (5) technical checks of reproducibility; (6) meaningfulness to investigators, respondents, and users; and (7) an overall aesthetic appeal of the questionnaire. These criteria have guided the design of a validated 5-item generic, global quality-of-life questionnaire (QOL5), and a validated 317-item generic, global quality-of-life questionnaire (SEQOL), administered to a well-documented birth cohort of 7,400 Danes born in 1959-1961, as well as to a reference sample of 2,500 Danes. Presented in outline, the underlying integrative quality-of-life (IQOL) theory is a meta-theory. To illustrate the seven criteria at work, we show the extent to which they are satisfied by one of the eight component theories. Next, two sample results of our investigation are presented: satisfaction with one's sex life has the expected covariation with one's quality of life, and so does mother's smoking during pregnancy, albeit to a much smaller extent. It is concluded that the methodological framework presented has proved helpful in designing a questionnaire that is capable of yielding acceptably valid and reliable measurements of global and generic quality of life.

Humans↗