Is funding source related to study reporting quality in obesity or nutrition randomized control trials in top-tier medical journals?

BACKGROUND: Faithful and complete reporting of trial results is essential to the validity of the scientific literature. An earlier systematic study of randomized controlled trials (RCTs) found that industry-funded RCTs appeared to be reported with greater quality than non-industry-funded RCTs. The aim of this study was to examine the association between systematic differences in reporting quality and funding status (that is, industry funding vs non-industry funding) among recent obesity and nutrition RCTs published in top-tier medical journals. METHODS: Thirty-eight obesity or nutrition intervention RCT articles were selected from high-profile, general medical journals (The Lancet, Annals of Internal Medicine, JAMA and the British Medical Journal) published between 2000 and 2007. Paired papers were selected from the same journal published in the same year, one with and the other without industry funding. The following identifying information was redacted: journal, title, authors, funding source and institution(s). Then three raters independently and blindly rated each paper according to the Chalmers method, and total reporting quality scores were calculated. FINDINGS: The inter-rater reliability (Cronbach's alpha) was 0.82 (95% confidence interval = 0.80-0.84). The total mean (M) and s.d. of Chalmers Index quality score (out of a possible 100) for industry-funded studies were M = 84.5, s.d. = 7.04 and for non-industry-funded studies they were M = 79.4, s.d. = 13.00. A Wilcoxon matched-pairs signed-ranks test indicates no significant rank difference in the distributions of total quality scores between funding sources, Z = -0.966, P = 0.334 (two tailed). INTERPRETATION: Recently published RCTs on nutrition and obesity that appear in top-tier journals seem to be equivalent in quality of reporting, regardless of funding source. This may be a result of recent reporting of quality statements and efforts of journal editors to raise all papers to a common standard.

Simplified dispatch-assisted CPR instructions outperform standard protocol.

OBJECTIVE: Dispatch-assisted chest compressions only CPR (CC-CPR) has gained widespread acceptance, and recent research suggests that increasing the proportion of compression time during CPR may increase survival from out-of-hospital cardiac arrest. We created a simplified CC-CPR protocol to reduce time to start chest compressions and to increase the proportion of time spent delivering chest compressions. This simplified protocol was compared to a published protocol, Medical Priority Dispatch System (MPDS) Version 11.2, recommended by the National Academies of Emergency Dispatch. METHODS: Subjects were randomized to the MPDS v11.2 protocol or a simplified protocol. Data was recorded from a Laerdal Resusci Anne Skillreporter manikin. A simulated emergency medical dispatcher, contacted by cell phone, delivered standardized instructions for both protocols. Outcomes included chest compression rate, depth, hand position, full release, overall proportion of compressions without error, time to start of CPR and total hands-off chest time. Proportions were analyzed by Wilcoxon's Rank Sum tests and time variables with Welch ANOVA and Wilcoxon's Rank Sum test. All tests used a two-sided alpha-level of 0.05. RESULTS: One hundred and seventeen subjects were randomized prospectively, 58 to the standard protocol and 59 to the simplified protocol. The average age of subjects in both groups was 25 years old. For both groups, the compression rate was equivalent (104 simplified versus 94 MPDS, p = 0.13), as was the proportion with total release (1.0 simplified versus 1.0 MPDS, p = 0.09). The proportion to the correct depth was greater in the simplified protocol (0.31 versus 0.03, p < 0.01), as was the proportion of compressions done without error (0.05 versus 0.0, p = 0.16). Time to start of chest compressions and total hands-off chest time were better in the simplified protocol (start time 60.9s versus 78.6s, p < 0.0001; hands-off chest time 69 s versus 95 s, p < 0.0001). The proportion with correct hand position, however, was worse in the simplified protocol (0.35 versus 0.84, p < 0.01). CONCLUSIONS: The simplified protocol was as good as, or better than the MPDS v11.2 protocol in every aspect studied except hand position, and the simplified protocol resulted in significant time savings. The protocol may need modification to ensure correct hand position. Time savings and improved quality of CPR achieved by the new set of instructions could be important in strengthening critical links in the cardiac chain of survival.

Role of MR imaging in the management of "skier's thumb" injuries.

"Skier's thumb" is an acute rupture of the ulnar collateral ligament (UCL) of the metacarpophalangeal (MCP) joint of the thumb. As the method of choice in evaluating soft tissue injuries, MR imaging is useful in evaluating UCL injuries. This article reviews current concepts regarding the rupture of the UCL, including a study of 34 UCL injuries in which MR imaging was used as the main diagnostic tool. When correlated with surgical findings, MR imaging resulted in identifying UCL tears with 96% sensitivity and 95% specificity.

Long-term effects of aldosterone blockade in resistant hypertension associated with chronic kidney disease.

Hypertension is a major risk factor for the development and progression of chronic kidney disease (CKD). Mineralocorticoid receptor antagonists (MRAs) are effective in the management of resistant hypertension but are not widely used in CKD because of the risk of hyperkalemia. We retrospectively evaluated the long-term effects and safety of MRAs added to a pre-existing antihypertensive regimen in subjects with resistant hypertension associated with stage 3 CKD. In all, 32 patients were treated with spironolactone and 4 with eplerenone for a median follow-up of 312 days. MRAs induced a significant decrease in systolic blood pressure from 162±22 to 138±14 mm Hg (P<0.0001) and in diastolic blood pressure from 87±17 to 74±12 mm Hg (P<0.0001). Serum potassium increased from 4.0±0.5 to 4.4±0.5 mEq l(-1) (P=0.0001), with the highest value being 5.8 mEq l(-1). The serum creatinine increased from 1.5±0.3 to 1.8±0.5 mg dl(-1) (P=0.0004) and the estimated glomerular filtration rate decreased from 48.6±8.7 to 41.2±11.5 ml min(-1) per 1.73 m(2) (P=0.0002). One case of acute renal failure and three cases of significant hyperkalemia occurred. MRAs significantly reduced blood pressure in subjects with resistant hypertension associated with stage 3 CKD, although close biochemical monitoring is recommended because of an increased risk of hyperkalemia and worsening of renal function.

The CombiRx trial of combined therapy with interferon and glatiramer acetate in relapsing remitting MS: Design and baseline characteristics.

BACKGROUND: Interferon-ß1a (IFNB) and glatiramer acetate (GA) are distinct therapies which are both partially effective for relapsing MS. It is not known if combining the two treatments would be more effective. OBJECTIVE: To review the rationale, design, and baseline characteristics of the CombiRx study of combined treatment with IFNB and GA. METHODS: The key inclusion criteria included a diagnosis of relapsing MS, at least 2 episodes of MS activity in the previous 3 years, expanded disability status scale of 0-5.5, and no prior treatment with either IFNB or GA. Subjects were randomized to IFNB+GA, IFNB monotherapy, or GA monotherapy in a 2:1:1 ratio. RESULTS: From 2005 to 2009, we enrolled 1008 subjects. The participants were 72.4% female and 87.6% Caucasian with a mean age of 37.7 years. The median duration of symptoms was 2 years at entry into the study, and the mean EDSS was 2.1. On the baseline MRI, the mean total lesion load was 12.2ml, and 40% of the participants had enhancing lesions. CONCLUSION: We have recruited a population of patients with clinical and MRI characteristics typical for early MS. The study results will aid in deciding on the optimum early treatment. This trial should serve as a model for future studies of combination therapy.

Spironolactone reduces severity of obstructive sleep apnoea in patients with resistant hypertension: a preliminary report.

Obstructive sleep apnoea (OSA) and hyperaldosteronism are very common in subjects with resistant hypertension. We hypothesized that aldosterone-mediated chronic fluid retention may influence OSA severity in patients with resistant hypertension. We tested this in an open-label evaluation by assessing the changes in the severity of OSA in patients with resistant hypertension after treatment with spironolactone. Subjects with resistant hypertension (clinical blood pressure (BP) >or=140/90 mm Hg on >or=3 antihypertensive medications, including a thiazide diuretic and OSA (defined as an apnoea-hypopnoea index (AHI) >or=15) had full diagnostic, polysomnography before and 8 weeks after spironolactone (25-50 mg a day) was added to their ongoing antihypertensive therapy. In all, 12 patients (mean age 56 years and body mass index 36.8 kg m(-2)) were evaluated. After treatment with spironolactone, the AHI (39.8+/-19.5 vs 22.0+/-6.8 events/h; P<0.05) and hypoxic index (13.6+/-10.8 vs 6.7+/-6.6 events/h; P<0.05), weight and clinic and ambulatory BP were significantly reduced. Plasma renin activity (PRA) and serum creatinine were significantly higher. This study provides preliminary evidence that treatment with a mineralocorticoid receptor antagonist substantially reduces the severity of OSA. If confirmed in a randomized assessment, it will support aldosterone-mediated chronic fluid retention as an important mediator of OSA severity in patients with resistant hypertension.