[Show abstract][Hide abstract] ABSTRACT: Background:
Publication of clinical research findings in prominent journals influences health beliefs and medical practice, in part by engendering news coverage. Randomized controlled trials (RCTs) should be most influential in guiding clinical practice. We determined whether study design of clinical research published in high-impact journals influences media coverage.
Methods and findings:
We compared the incidence and amount of media coverage of RCTs with that of observational studies published in the top 7 medical journals between 1 January 2013 and 31 March 2013. We specifically assessed media coverage of the most rigorous RCTs, those with >1000 participants that reported 'hard' outcomes. There was no difference between RCTs and observational studies in coverage by major newspapers or news agencies, or in total number of news stories generated (all P>0.63). Large RCTs reporting 'hard' outcomes did not generate more news coverage than small RCTs that reported surrogate outcomes and observational studies (all P>0.32). RCTs were more likely than observational studies to attract a journal editorial (70% vs 46%, P = 0.003), but less likely to be the subject of a journal press release (17% vs 50%, P<0.001). Large RCTs that reported 'hard' outcomes did not attract an editorial more frequently than other studies (61% vs 58%, P>0.99), nor were they more likely to be the subject of a journal press release (14% vs 38%, P = 0.14).
The design of clinical studies whose results are published in high-impact medical journals is not associated with the likelihood or amount of ensuing news coverage.
[Show abstract][Hide abstract] ABSTRACT: Objective:
Numerous guidelines advise about management of osteoporosis, but little research has been conducted on their recommendations. We analysed recommendations on management of bone health in clinical guidelines.
We surveyed recommendations on assessment, treatment and monitoring of bone health in 78 clinical guidelines (22 primary focus osteoporosis, 56 primary focus not osteoporosis) lodged at the Agency for Health Research and Quality National Guidelines Clearinghouse between 1/1/2009 and 12/31/2014.
Governance of guidelines; discussion of fracture risk in the target population; recommendations for assessment, treatment and monitoring of bone health.
Only 14% of guidelines discussed fracture risk in the target population. When guidelines discussed assessment, 98% recommended bone mineral density (BMD) measurement but only 27% recommended estimation of fracture risk. When guidelines discussed treatment, 63-71% recommended calcium and/or vitamin D, while <12% recommended avoiding low body weight or smoking cessation. When guidelines discussed intervention, 53% did so on the basis of BMD measurement, and only 27% on the basis of estimated fracture risk. When guidelines discussed monitoring, >90% recommended BMD measurements, and only 3% recommended estimation of fracture risk. 65% of guidelines that suggested a BMD monitoring interval recommended one of ≤3y. Compared to guidelines with a primary focus on osteoporosis, guidelines whose primary focus was not osteoporosis were less likely to discuss fracture risk in the target population (2% vs 45%), recommend estimation of fracture risk (11% vs 55%), and recommend intervention on the basis of estimated fracture risk (10% vs 67%) (all P <0.005).
Our findings highlight a strong focus in clinical guidelines on BMD, a surrogate measure, rather than fracture risk, the clinically important outcome, particularly when bone health is not the primary focus. Addressing this issue might facilitate more rational use of resources and improve patient care. This article is protected by copyright. All rights reserved.
No preview · Article · Dec 2015 · Clinical Endocrinology
[Show abstract][Hide abstract] ABSTRACT: Objective To investigate negative perceptions about generic medicines and evaluate the proportions of lay people, doctors and pharmacists who hold these perceptions.
Design A systematic review of observational studies.
Data sources MEDLINE, EMBASE, PsycInfo and Scopus.
Eligibility criteria Quantitative data from cross-sectional and prospective studies published in English after 1980, using self-report measures to evaluate perceptions about generic medicines, presented as percentages of the total sample assessed.
Results After screening 2737 articles, 52 articles were included in the final analysis. A high proportion of doctors, pharmacists and lay people had negative perceptions of generics. Lay people were significantly more likely to view generics as less effective than branded medication (35.6%, 95% CI 34.8% to 36.4%) compared to doctors (28.7%, 27.5% to 29.9%) and pharmacists (23.6%, 21.2% to 26.2%), p<0.0001. Pharmacists (33.4%, 31.0% to 35.9%) were significantly more likely to believe generics were of inferior quality compared to branded medication than were doctors (28.0%, 26.3% to 29.9%), p=0.0006, and lay people (25.1%, 24.2% to 26.0%), p<0.0001. Doctors believed generics caused more side effects than branded medication (24.4%, 22.2% to 26.9%), compared to pharmacists (17.6%, 15.3% to 20.1%) and lay people (18.8%, 17.8% to 19.8%), p<0.0001. Doctors (28.5%, 26.9% to 30.2%) and pharmacists (25.4%, 21.4% to 29.9%) had significantly more safety concerns about generics than did lay people (18.0%, 17.0% to 19.0%), p≤0.0002. A greater proportion of lay people felt negatively about generic substitution (34.0%, 33.2% to 34.9%), compared to doctors (24.1%, 22.0% to 26.4%) and pharmacists (11.0%, 9.6% to 12.7%), p<0.0001. Rates of negative perceptions of generics do not appear to have changed substantially over time in the general population or among physician groups, p≥0.431, but such negative beliefs show a decreasing trend in pharmacists over the study period, p=0.034.
Conclusions A significant proportion of doctors, pharmacists and lay people hold negative perceptions of generic medicines. It is likely these attitudes present barriers to the wider use of generics.
[Show abstract][Hide abstract] ABSTRACT: Objective:
To investigate the efficacy of 3-D printed bone models as a tool to facilitate initiation of bisphosphonate treatment among individuals who were newly diagnosed with osteoporosis.
58 participants with estimated fracture risk above that at which guidelines recommend pharmacological intervention were randomised to receive either a standard physician interview or an interview augmented by the presentation of 3-D bone models.
Main outcome measures:
Participants' beliefs about osteoporosis and bisphosphonate treatment, initiation of bisphosphonate therapy assessed at two months using self-report and pharmacy dispensing data.
Individuals in the 3-D bone model intervention condition were more emotionally affected by osteoporosis immediately after the interview (p = .04) and reported a greater understanding of osteoporosis at follow-up (p = .04), than the control group. While a greater proportion of the intervention group initiated an oral bisphosphonate regimen (alendronate) (52%) in comparison to the control group (21%), the overall initiation of medication for osteoporosis, including infusion (zoledronate), did not differ significantly (intervention group 62%, control group 45%, p=0.19).
The presentation of 3-D bone models during a medical consultation can modify cognitive and emotional representations relevant to treatment initiation among people with osteoporosis, and might facilitate commencement of bisphosphonate treatment.
Full-text · Article · Oct 2015 · Psychology & Health
[Show abstract][Hide abstract] ABSTRACT: Systematic reviews of randomized, controlled trials (RCTs) are considered the highest level of evidence to inform clinical practice. Meta-analyses of large RCTs of calcium and/or vitamin D supplements completed in the last 15 years provide strong evidence for clinical recommendations. These meta-analyses with data for > 50 000 older adults reported that calcium with or without vitamin D has only weak, inconsistent effects on fracture, and that vitamin D without calcium has no effect on fracture. Only one RCT of co-administered calcium and vitamin D in frail, institutionalized, elderly women with low dietary calcium intake and vitamin D levels showed significant reductions in fracture risk. These RCTs have also reported previously unrecognized adverse events of calcium supplements including kidney stones, myocardial infarction, hypercalcemia, and hospitalization with acute gastrointestinal symptoms. The small risk of these important adverse effects, together with the moderate risk of minor side-effects such as constipation, probably outweighs any benefits of calcium supplements on fracture. These data suggest the role for calcium and vitamin D supplements in osteoporosis management is very limited. Neither calcium nor vitamin D supplements should be recommended for fracture prevention in community-dwelling adults, although vitamin D should be considered for prevention of osteomalacia in at-risk individuals.
[Show abstract][Hide abstract] ABSTRACT: Objective:
Branding medication with a known pharmaceutical company name or product name bestows on the drug an added assurance of authenticity and effectiveness compared to a generic preparation. This study examined the impact of brand name and generic labeling on medication effectiveness and side effects.
87 undergraduate students with frequent headaches took part in the study. Using a within-subjects counterbalanced design, each participant took tablets labeled either as brand name "Nurofen" or "Generic Ibuprofen" to treat each of 4 headaches. In reality, half of the tablets were placebos, and half were active ibuprofen (400 mg). Participants recorded their headache pain on a verbal descriptor and visual analogue scale prior to taking the tablets, and again 1 hour afterward. Medication side effects were also reported.
Pain reduction following the use of brand name labeled tablets was similar in active ibuprofen or a placebo. However, if the tablets had a generic label, placebo tablets were significantly less effective compared to active ibuprofen. Fewer side effects were attributed to placebo tablets with brand name labeling compared to the same placebo tablets with a generic label.
Branding of a tablet appears to have conferred a treatment benefit in the absence of an active ingredient, while generic labeled tablets were substantially less effective if they contained no active ingredient. Branding is also associated with reduced attribution of side effects to placebo tablets. Future interventions to improve perceptions of generics may have utility in improving treatment outcomes from generic drugs. (PsycINFO Database Record
Full-text · Article · Oct 2015 · Health Psychology
[Show abstract][Hide abstract] ABSTRACT: Background:
Observational studies (OS) and randomized controlled trials (RCTs) often report discordant results. In the Women's Health Initiative Calcium and Vitamin D (WHI CaD) RCT, women were randomly assigned to CaD or placebo, but were permitted to use personal calcium and vitamin D supplements, creating a unique opportunity to compare results from randomized and observational analyses within the same study.
WHI CaD was a 7-year RCT of 1g calcium/400IU vitamin D daily in 36,282 post-menopausal women. We assessed the effects of CaD on cardiovascular events, death, cancer and fracture in a randomized design- comparing CaD with placebo in 43% of women not using personal calcium or vitamin D supplements- and in a observational design- comparing women in the placebo group (44%) using personal calcium and vitamin D supplements with non-users. Incidence was assessed using Cox proportional hazards models, and results from the two study designs deemed concordant if the absolute difference in hazard ratios was ≤0.15. We also compared results from WHI CaD to those from the WHI Observational Study(WHI OS), which used similar methodology for analyses and recruited from the same population.
In WHI CaD, for myocardial infarction and stroke, results of unadjusted and 6/8 covariate-controlled observational analyses (age-adjusted, multivariate-adjusted, propensity-adjusted, propensity-matched) were not concordant with the randomized design results. For death, hip and total fracture, colorectal and total cancer, unadjusted and covariate-controlled observational results were concordant with randomized results. For breast cancer, unadjusted and age-adjusted observational results were concordant with randomized results, but only 1/3 other covariate-controlled observational results were concordant with randomized results. Multivariate-adjusted results from WHI OS were concordant with randomized WHI CaD results for only 4/8 endpoints.
Results of randomized analyses in WHI CaD were concordant with observational analyses for 5/8 endpoints in WHI CaD and 4/8 endpoints in WHI OS.
[Show abstract][Hide abstract] ABSTRACT: Objective To determine whether increasing calcium intake from dietary sources affects bone mineral density (BMD) and, if so, whether the effects are similar to those of calcium supplements. Design Random effects meta-analysis of randomised controlled trials. Data sources Ovid Medline, Embase, Pubmed, and references from relevant systematic reviews. Initial searches were undertaken in July 2013 and updated in September 2014. Eligibility criteria for selecting studies Randomised controlled trials of dietary sources of calcium or calcium supplements (with or without vitamin D) in participants aged over 50 with BMD at the lumbar spine, total hip, femoral neck, total body, or forearm as an outcome. Results We identified 59 eligible randomised controlled trials: 15 studied dietary sources of calcium (n=1533) and 51 studied calcium supplements (n=12 257). Increasing calcium intake from dietary sources increased BMD by 0.6-1.0% at the total hip and total body at one year and by 0.7-1.8% at these sites and the lumbar spine and femoral neck at two years. There was no effect on BMD in the forearm. Calcium supplements increased BMD by 0.7-1.8% at all five skeletal sites at one, two, and over two and a half years, but the size of the increase in BMD at later time points was similar to the increase at one year. Increases in BMD were similar in trials of dietary sources of calcium and calcium supplements (except at the forearm), in trials of calcium monotherapy versus co-administered calcium and vitamin D, in trials with calcium doses of ≥1000 versus 500 mg/day, and in trials where the baseline dietary calcium intake was
[Show abstract][Hide abstract] ABSTRACT: OBJECTIVE: To examine the evidence underpinning recommendations to increase calcium intake through dietary sources or calcium supplements to prevent fractures. DESIGN: Systematic review of randomised controlled trials and observational studies of calcium intake with fracture as an endpoint. RESULTS: from trials were pooled with random effects meta-analyses. DATA SOURCES: Ovid Medline, Embase, PubMed, and references from relevant systematic reviews. Initial searches undertaken in July 2013 and updated in September 2014. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials or cohort studies of dietary calcium, milk or dairy intake, or calcium supplements (with or without Vitamin D) with fracture as an outcome and participants aged >50. RESULTS: There were only two eligible randomised controlled trials of dietary sources of calcium (n=262), but 50 reports from 44 cohort studies of relations between dietary calcium (n=37), milk (n=14), or dairy intake (n=8) and fracture outcomes. For dietary calcium, most studies reported no association between calcium intake and fracture (14/22 for total, 17/21 for hip, 7/8 for vertebral, and 5/7 for forearm fracture). For milk (25/28) and dairy intake (11/13), most studies also reported no associations. In 26 randomised controlled trials, calcium supplements reduced the risk of total fracture (20 studies, n=58 573; relative risk 0.89, 95% confidence interval 0.81 to 0.96) and vertebral fracture (12 studies, n=48 967. 0.86, 0.74 to 1.00) but not hip (13 studies, n=56 648; 0.95, 0.76 to 1.18) or forearm fracture (eight studies, n=51 775; 0.96, 0.85 to 1.09). Funnel plot inspection and Egger's regression suggested bias toward calcium supplements in the published data. In randomised controlled trials at lowest risk of bias (four studies, n=44 505), there was no effect on risk of fracture at any site. RESULTS: were similar for trials of calcium monotherapy and co-administered calcium and Vitamin D. Only one trial in frail elderly women in residential care with low dietary calcium intake and Vitamin D concentrations showed significant reductions in risk of fracture. CONCLUSIONS: Dietary calcium intake is not associated with risk of fracture, and there is no clinical trial evidence that increasing calcium intake from dietary sources prevents fractures. Evidence that calcium supplements prevent fractures is weak and inconsistent.
[Show abstract][Hide abstract] ABSTRACT: Aims/hypothesis
Thiazolidinediones (TZDs) are associated with an increased risk of fracture but the mechanism is unclear. We sought to determine the effect of TZDs on bone mineral density (BMD) and bone turnover markers.
PubMed, EMBASE and Cochrane CENTRAL databases were searched from inception until January 2015 for randomised controlled trials comparing TZDs with metformin, sulfonylureas or placebo, and those reporting changes in BMD and/or bone turnover markers. The primary outcome was percentage change in BMD from baseline and results were pooled with random effects meta-analyses.
In all, 18 trials were included in the primary analyses and another two were included in the sensitivity analyses (n = 3,743, 50% women, mean age 56 years, median trial duration 48 weeks). TZDs decreased BMD at the lumbar spine (difference −1.1% [95% CI −1.6, −0.7]; p