Summary Research publication can both communicate and miscommunicate. Unless research is adequately reported, the time and resources invested in the conduct of research is wasted. Reporting ...guidelines such as CONSORT, STARD, PRISMA, and ARRIVE aim to improve the quality of research reports, but all are much less adopted and adhered to than they should be. Adequate reports of research should clearly describe which questions were addressed and why, what was done, what was shown, and what the findings mean. However, substantial failures occur in each of these elements. For example, studies of published trial reports showed that the poor description of interventions meant that 40–89% were non-replicable; comparisons of protocols with publications showed that most studies had at least one primary outcome changed, introduced, or omitted; and investigators of new trials rarely set their findings in the context of a systematic review, and cited a very small and biased selection of previous relevant trials. Although best documented in reports of controlled trials, inadequate reporting occurs in all types of studies—animal and other preclinical studies, diagnostic studies, epidemiological studies, clinical prediction research, surveys, and qualitative studies. In this report, and in the Series more generally, we point to a waste at all stages in medical research. Although a more nuanced understanding of the complex systems involved in the conduct, writing, and publication of research is desirable, some immediate action can be taken to improve the reporting of research. Evidence for some recommendations is clear: change the current system of research rewards and regulations to encourage better and more complete reporting, and fund the development and maintenance of infrastructure to support better reporting, linkage, and archiving of all elements of research. However, the high amount of waste also warrants future investment in the monitoring of and research into reporting of research, and active implementation of the findings to ensure that research reports better address the needs of the range of research users.
Antibiotics for sore throat Spinks, Anneliese; Glasziou, Paul P; Del Mar, Chris B
Cochrane database of systematic reviews,
11/2013
11
Journal Article
Recenzirano
Odprti dostop
Sore throat is a common reason for people to present for medical care. Although it remits spontaneously, primary care doctors commonly prescribe antibiotics for it.
To assess the benefits of ...antibiotics for sore throat for patients in primary care settings.
We searched CENTRAL 2013, Issue 6, MEDLINE (January 1966 to July week 1, 2013) and EMBASE (January 1990 to July 2013).
Randomised controlled trials (RCTs) or quasi-RCTs of antibiotics versus control assessing typical sore throat symptoms or complications.
Two review authors independently screened studies for inclusion and extracted data. We resolved differences in opinion by discussion. We contacted trial authors from three studies for additional information.
We included 27 trials with 12,835 cases of sore throat. We did not identify any new trials in this 2013 update. 1. Symptoms Throat soreness and fever were reduced by about half by using antibiotics. The greatest difference was seen at day three. The number needed to treat to benefit (NNTB) to prevent one sore throat at day three was less than six; at week one it was 21. 2. Non-suppurative complications The trend was antibiotics protecting against acute glomerulonephritis but there were too few cases to be sure. Several studies found antibiotics reduced acute rheumatic fever by more than two-thirds within one month (risk ratio (RR) 0.27; 95% confidence interval (CI) 0.12 to 0.60). 3. Suppurative complications Antibiotics reduced the incidence of acute otitis media within 14 days (RR 0.30; 95% CI 0.15 to 0.58); acute sinusitis within 14 days (RR 0.48; 95% CI 0.08 to 2.76); and quinsy within two months (RR 0.15; 95% CI 0.05 to 0.47) compared to those taking placebo. 4. Subgroup analyses of symptom reduction Antibiotics were more effective against symptoms at day three (RR 0.58; 95% CI 0.48 to 0.71) if throat swabs were positive for Streptococcus, compared to RR 0.78; 95% CI 0.63 to 0.97 if negative. Similarly at week one the RR was 0.29 (95% CI 0.12 to 0.70) for positive and 0.73 (95% CI 0.50 to 1.07) for negative Streptococcus swabs.
Antibiotics confer relative benefits in the treatment of sore throat. However, the absolute benefits are modest. Protecting sore throat sufferers against suppurative and non-suppurative complications in high-income countries requires treating many with antibiotics for one to benefit. This NNTB may be lower in low-income countries. Antibiotics shorten the duration of symptoms by about 16 hours overall.
Gestational diabetes mellitus (GDM) - a transitory form of diabetes induced by pregnancy - has potentially important short and long-term health consequences for both the mother and her baby. There is ...no globally agreed definition of GDM, but definition changes have increased the incidence in some countries in recent years, with some research suggesting minimal clinical improvement in outcomes. The aim of this qualitative systematic review was to identify the psychosocial experiences a diagnosis of GDM has on women during pregnancy and the postpartum period.
We searched CINAHL, EMBASE, MEDLINE and PsycINFO databases for studies that provided qualitative data on the psychosocial experiences of a diagnosis of GDM on women across any stage of pregnancy and/or the postpartum period. We appraised the methodological quality of the included studies using the Critical Appraisal Skills Programme Checklist for Qualitative Studies and used thematic analysis to synthesis the data.
Of 840 studies identified, 41 studies of diverse populations met the selection criteria. The synthesis revealed eight key themes: initial psychological impact; communicating the diagnosis; knowledge of GDM; risk perception; management of GDM; burden of GDM; social support; and gaining control. The identified benefits of a GDM diagnosis were largely behavioural and included an opportunity to make healthy eating changes. The identified harms were emotional, financial and cultural. Women commented about the added responsibility (eating regimens, appointments), financial constraints (expensive food, medical bills) and conflicts with their cultural practices (alternative eating, lack of information about traditional food). Some women reported living in fear of risking the health of their baby and conducted extreme behaviours such as purging and starving themselves.
A diagnosis of GDM has wide reaching consequences that are common to a diverse group of women. Threshold cut-offs for blood glucose levels have been determined using the risk of physiological harms to mother and baby. It may also be advantageous to consider the harms and benefits from a psychosocial and a physiological perspective. This may avoid unnecessary burden to an already vulnerable population.
Summary The biomedical research complex has been estimated to consume almost a quarter of a trillion US dollars every year. Unfortunately, evidence suggests that a high proportion of this sum is ...avoidably wasted. In 2014, The Lancet published a series of five reviews showing how dividends from the investment in research might be increased from the relevance and priorities of the questions being asked, to how the research is designed, conducted, and reported. 17 recommendations were addressed to five main stakeholders—funders, regulators, journals, academic institutions, and researchers. This Review provides some initial observations on the possible effects of the Series, which seems to have provoked several important discussions and is on the agendas of several key players. Some examples of individual initiatives show ways to reduce waste and increase value in biomedical research. This momentum will probably move strongly across stakeholder groups, if collaborative relationships evolve between key players; further important work is needed to increase research value. A forthcoming meeting in Edinburgh, UK, will provide an initial forum within which to foster the collaboration needed.
Financial ties between health professionals and industry may unduly influence professional judgments and some researchers have suggested that widening disease definitions may be one driver of ...over-diagnosis, bringing potentially unnecessary labeling and harm. We aimed to identify guidelines in which disease definitions were changed, to assess whether any proposed changes would increase the numbers of individuals considered to have the disease, whether potential harms of expanding disease definitions were investigated, and the extent of members' industry ties.
We undertook a cross-sectional study of the most recent publication between 2000 and 2013 from national and international guideline panels making decisions about definitions or diagnostic criteria for common conditions in the United States. We assessed whether proposed changes widened or narrowed disease definitions, rationales offered, mention of potential harms of those changes, and the nature and extent of disclosed ties between members and pharmaceutical or device companies. Of 16 publications on 14 common conditions, ten proposed changes widening and one narrowing definitions. For five, impact was unclear. Widening fell into three categories: creating "pre-disease"; lowering diagnostic thresholds; and proposing earlier or different diagnostic methods. Rationales included standardising diagnostic criteria and new evidence about risks for people previously considered to not have the disease. No publication included rigorous assessment of potential harms of proposed changes. Among 14 panels with disclosures, the average proportion of members with industry ties was 75%. Twelve were chaired by people with ties. For members with ties, the median number of companies to which they had ties was seven. Companies with ties to the highest proportions of members were active in the relevant therapeutic area. Limitations arise from reliance on only disclosed ties, and exclusion of conditions too broad to enable analysis of single panel publications.
For the common conditions studied, a majority of panels proposed changes to disease definitions that increased the number of individuals considered to have the disease, none reported rigorous assessment of potential harms of that widening, and most had a majority of members disclosing financial ties to pharmaceutical companies. Please see later in the article for the Editors' Summary.
Incomplete reporting has been identified as a major source of avoidable waste in biomedical research. Essential information is often not provided in study reports, impeding the identification, ...critical appraisal, and replication of studies. To improve the quality of reporting of diagnostic accuracy studies, the Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement was developed. Here we present STARD 2015, an updated list of 30 essential items that should be included in every report of a diagnostic accuracy study. This update incorporates recent evidence about sources of bias and variability in diagnostic accuracy and is intended to facilitate the use of STARD. As such, STARD 2015 may help to improve completeness and transparency in reporting of diagnostic accuracy studies.
Background: Knowing the prevalence of true asymptomatic coronavirus disease 2019 (COVID-19) cases is critical for designing mitigation measures against the pandemic. We aimed to synthesize all ...available research on asymptomatic cases and transmission rates. Methods: We searched PubMed, Embase, Cochrane COVID-19 trials, and Europe PMC for primary studies on asymptomatic prevalence in which (1) the sample frame includes at-risk populations and (2) follow-up was sufficient to identify pre-symptomatic cases. Meta-analysis used fixed-effects and random-effects models. We assessed risk of bias by combination of questions adapted from risk of bias tools for prevalence and diagnostic accuracy studies. Results: We screened 2,454 articles and included 13 low risk-of-bias studies from seven countries that tested 21,708 at-risk people, of which 663 were positive and 111 asymptomatic. Diagnosis in all studies was confirmed using a real-time reverse transcriptase–polymerase chain reaction test. The asymptomatic proportion ranged from 4% to 41%. Meta-analysis (fixed effects) found that the proportion of asymptomatic cases was 17% (95% CI 14% to 20%) overall and higher in aged care (20%; 95% CI 14% to 27%) than in non-aged care (16%; 95% CI 13% to 20%). The relative risk (RR) of asymptomatic transmission was 42% lower than that for symptomatic transmission (combined RR 0.58; 95% CI 0.34 to 0.99, p = 0.047). Conclusions: Our one-in-six estimate of the prevalence of asymptomatic COVID-19 cases and asymptomatic transmission rates is lower than those of many highly publicized studies but still sufficient to warrant policy attention. Further robust epidemiological evidence is urgently needed, including in subpopulations such as children, to better understand how asymptomatic cases contribute to the pandemic.
Reducing mortality from colorectal cancer (CRC) may be achieved by the introduction of population-based screening programs. The aim of the systematic review was to update previous research to ...determine whether screening for CRC using the fecal occult blood test (FOBT) reduces CRC mortality and to consider the benefits, harms, and potential consequences of screening.
We searched eight electronic databases (Cochrane Library, MEDLINE, EMBASE, CINAHL, PsychINFO, AMED, SIGLE, and HMIC). We identified nine articles describing four randomized controlled trials (RCTs) involving over 320,000 participants with follow-up ranging from 8 to 18 yr. The primary analyses used intention to screen and a secondary analysis adjusted for nonattendance. We calculated the relative risks and risk differences for each trial, and then overall, using fixed and random effects models.
Combined results from the four eligible RCTs indicated that screening had a 16% reduction in the relative risk (RR) of CRC mortality (RR 0.84, 95% confidence interval CI 0.78-0.90). There was a 15% RR reduction (RR 0.85, 95% CI 0.78-0.92) in CRC mortality for studies that used biennial screening. When adjusted for screening attendance in the individual studies, there was a 25% RR reduction (RR 0.75, 95% CI 0.66-0.84) for those attending at least one round of screening using the FOBT. There was no difference in all-cause mortality (RR 1.00, 95% CI 0.99-1.02) or all-cause mortality excluding CRC (RR 1.01, 95% CI 1.00-1.03).
The present review includes seven new publications and unpublished data concerning CRC screening using FOBT. This review confirms previous research demonstrating that FOBT screening reduces the risk of CRC mortality. The results also indicate that there is no difference in all-cause mortality between the screened and nonscreened populations.
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