Sally E. M. Bell-Syer

Hormone replacement therapy and prevention of vertebral fractures: a meta-analysis of randomised trials

BackgroundHormone replacement therapy (HRT) is often seen as the treatment of choice for preventing fractures in women. We undertook a recent meta-analysis of randomised trials which suggested that HRT reduced non-vertebral fractures by 30%. In this analysis we extend that analysis to vertebral fractures.MethodsWe searched the main electronic databases until the end of August 2001. We sought all randomised controlled trials (RCTs) of HRT where women had been randomised to at least 12 months of HRT or to no HRT.ResultsWe found 13 RCTs. Overall there was a 33% reduction in vertebral factures (95% confidence interval (CI) 45% to 98%).ConclusionsThis review and meta-analysis showed a significant reduction in vertebral fractures associated with HRT use.

Systematic review of topical treatments for fungal infections of the skin and nails of the feet

Abstract Objective: To identify and synthesise the evidence for efficacy and cost effectiveness of topical treatments for superficial fungal infections of the skin and nails of the feet. Design: Systematic review. Interventions: Topical treatments for superficial fungal infections. Main outcome measures: Cure confirmed by culture and microscopy for skin and by culture for nails in patients with clinically diagnosed fungal infections. Results: Of 126 trials identified in 121 papers, 72 (57.1%) met the inclusion criteria. Placebo controlled trials yielded pooled relative risks of failure to cureskin infections: allylamines (0.30, 95% confidence interval 0.24 to 0.38); azoles (0.54, 0.42 to 0.68); undecenoic acid (0.28, 0.11 to 0.74); and tolnaftate (0.46, 0.17 to 1.22). Although meta-analysis of 11 trials comparing allylamines and azoles showed a relative risk of failure to cure of 0.88 (0.78 to 0.99) in favour of allylamines, there was evidenceof language bias. Seven reports in English favoured allylamines (0.79, 0.69 to 0.91), butfour reports in foreign languages showed no difference between the two drugs (1.01, 0.90 to 1.13). Neither trial of nail infections showed significant differences between alternative topical treatments. Conclusions: Allylamines, azoles, and undecenoic acid were efficacious in placebo controlled trials. There are sufficient comparative trials to judge relative efficacy only between allylamines and azoles. Allylamines cure slightly more infections than azoles but are much more expensive than azoles. The most cost effective strategy is first to treat with azoles or undecenoic acid and to use allylamines only if that fails. Key messages About 15% of the population have fungal infections of the skin or nails of the foot Topical allylamines—available only on prescription—cure slightly more infections of the skin of the foot than topical azoles or undecenoic acid, both of which are available over the counter No significant differences in efficacy between individual allylamines or individual azoles were found Allylamines cost more than over the counter preparations and their few extra cures are expensive, with a marginal cost per cure that is more than five times as high as that of azoles Topical allylamines are therefore best reserved for athletes foot that does not respond to initial treatment with azoles or undecenoic acid

Preventing pressure ulcers--Are pressure-redistributing support surfaces effective? A Cochrane systematic review and meta-analysis.

OBJECTIVES To undertake a systematic review of the effectiveness of pressure redistributing support surfaces in the prevention of pressure ulcers. DESIGN Systematic review and meta-analysis. DATA SOURCES Cochrane Wound Group Specialised Register, The Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Ovid EMBASE and EBSCO CINAHL. The reference sections of included trials were searched for further trials. REVIEW METHODS Randomised controlled trials and quasi-randomised trials, published or unpublished, which assessed the effects of support surfaces in preventing pressure ulcers (of any grade), in any patient group, in any setting compared to any other support surface, were sought. Two reviewers extracted and summarised details of eligible trials using a standardised form and assessed the methodological quality of each trial using the Cochrane risk of bias tool. RESULTS Fifty-three eligible trials were identified with a total of 16,285 study participants. Overall the risk of bias in the included trials was high. Pooled analysis showed that: (i) foam alternatives to the standard hospital foam mattress reduce the incidence of pressure ulcers in people at risk (RR 0.40, 95% CI 0.21-0.74) and Australian standard medical sheepskins prevent pressure ulcers compared to standard care (RR 0.48, 95% CI 0.31-0.74). Pressure-redistributing overlays on the operating table compared to standard care reduce postoperative pressure ulcer incidence (RR 0.53, 95% CI 0.33-0.85). CONCLUSIONS While there is good evidence that higher specification foam mattresses, sheepskins, and that some overlays in the operative setting are effective in preventing pressure ulcers, there is insufficient evidence to draw conclusions on the value of seat cushions, limb protectors and various constant low pressure devices. The relative merits of higher-tech constant low pressure and alternating pressure for prevention are unclear. More robust trials are required to address these research gaps.

A systematic review of oral treatments for fungal infections of the skin of the feet

OBJECTIVE: To synthesize the evidence for the effectiveness and cost-effectiveness of oral treatments for fungal infections of the skin of the feet. DESIGN: Systematic review. INTERVENTIONS: Oral treatments for fungal infections. METHODS: Ten electronic databases, four journals and the bibliographies of all review papers identified were searched. The authors also wrote to international pharmaceutical companies and all podiatry schools in the UK. The studies selected were randomized trials of clinically diagnosed fungal skin infections of the foot that confirmed cure by culture and microscopy. Two reviewers independently selected trials and abstracted data using a structured tool including 12 recognized quality criteria. RESULTS: Of 26 trials identified, 12 met the inclusion criteria and evaluated five different treatments. Single placebo-controlled trials showed that terbinafine and itraconazole were both effective. Two trials showed that terbinafine cures 50% more patients than griseofulvin. Four trials compared terbinafine with itraconazole, one showed that terbinafine given for 2 weeks had a better cure rate than 2 weeks of itraconazole, but the other three showed that it was no better than 4 weeks of itraconazole. CONCLUSIONS: There is significant evidence that terbinafine is more effective than griseofulvin, though more costly. There is weak evidence that terbinafine may be more cost-effective than itraconazole. Firm recommendations about the choice between terbinafine and the azoles need further research.OBJECTIVE To synthesize the evidence for the effectiveness and cost-effectiveness of oral treatments for fungal infections of the skin of the feet. DESIGN Systematic review. INTERVENTIONS Oral treatments for fungal infections. METHODS Ten electronic databases, four journals and the bibliographies of all review papers identified were searched. The authors also wrote to international pharmaceutical companies and all podiatry schools in the UK. The studies selected were randomized trials of clinically diagnosed fungal skin infections of the foot that confirmed cure by culture and microscopy. Two reviewers independently selected trials and abstracted data using a structured tool including 12 recognized quality criteria. RESULTS Of 26 trials identified, 12 met the inclusion criteria and evaluated five different treatments. Single placebo-controlled trials showed that terbinafine and itraconazole were both effective. Two trials showed that terbinafine cures 50% more patients than griseofulvin. Four trials compared terbinafine with itraconazole, one showed that terbinafine given for 2 weeks had a better cure rate than 2 weeks of itraconazole, but the other three showed that it was no better than 4 weeks of itraconazole. CONCLUSIONS There is significant evidence that terbinafine is more effective than griseofulvin, though more costly. There is weak evidence that terbinafine may be more cost-effective than itraconazole. Firm recommendations about the choice between terbinafine and the azoles need further research.

GP Participation and Recruitment of Patients to RCTs: Lessons from Trials of Acupuncture and Exercise for Low Back Pain in Primary Care

The objective of this study was to identify factors associated with general practitioner (GP) participation and the recruitment of people to trials in primary care, based on data from two trials of interventions for treating chronic low back pain. The study was based on data from two randomized controlled trials (RCTs), one involving exercise, the other acupuncture, and subsequent reporting by GPs in a postal questionnaire. The exercise trial achieved 62% recruitment whereas the acupuncture trial achieved 100% recruitment. In both trials GPs most efficient at referring patients were those with a special interest in the subject area, and those known personally to the research team. A follow-up GP questionnaire found that both trials had maintained a high profile with over 80% of GPs, and successful recruitment strategies included project reminder letters, updates and personal contacts. Achieving target recruitment of patients in the acupuncture trial was aided by the deliberate application of lessons learned in the exercise trial, in particular the need to keep initial study entry criteria broad, with subsequent filtering undertaken by the study researcher. In addition the use of effective methods of maintaining the trial profile, the involvement of a GP advisor, the decision to maximize the recruitment of GPs early in the trial and the direct recruitment of interested individual GPs. The successful recruitment of patients to trials in primary care requires careful planning and continuous monitoring from the outset. Prior to starting recruitment, it is useful to identify previous trials in a similar environment in order to learn from their experience and optimize patient recruitment.

Funding source and the quality of reports of chronic wounds trials: 2004 to 2011

BackgroundCritical commentaries suggest that wound care randomised controlled trials (RCTs) are often poorly reported with many methodological flaws. Furthermore, interventions in chronic wounds, rather than being drugs, are often medical devices for which there are no requirements for RCTs to bring products to market. RCTs in wounds trials therefore potentially represent a form of marketing. This study presents a methodological overview of chronic wound trials published between 2004 and 2011 and investigates the influence of industry funding on methodological quality.MethodsA systematic search for RCTs for the treatment of chronic wounds published in the English language between 2004 and 2011 (inclusive) in the Cochrane Wounds Group Specialised Register of Trials was carried out.Data were extracted on aspects of trial design, conduct and quality including sample size, duration of follow-up, specification of a primary outcome, use of surrogate outcomes, and risks of bias. In addition, the prevalence of industry funding was assessed and its influence on the above aspects of trial design, conduct and quality was assessed.ResultsA total of 167 RCTs met our inclusion criteria. We found chronic wound trials often have short durations of follow-up (median 12 weeks), small sample sizes (median 63), fail to define a primary outcome in 41% of cases, and those that do define a primary outcome, use surrogate measures of healing in 40% of cases. Only 40% of trials used appropriate methods of randomisation, 25% concealed allocation and 34% blinded outcome assessors. Of the included trials, 41% were wholly or partially funded by industry, 33% declared non-commercial funding and 26% did not report a funding source. Industry funding was not statistically significantly associated with any measure of methodological quality, though this analysis was probably underpowered.ConclusionsThis overview confirms concerns raised about the methodological quality of RCTs in wound care and illustrates that greater efforts must be made to follow international standards for conducting and reporting RCTs. There is currently minimal evidence of an influence of industry funding on methodological quality although analyses had limited power and funding source was not reported for a quarter of studies.

A scoping review of competencies for scientific editors of biomedical journals

BackgroundBiomedical journals are the main route for disseminating the results of health-related research. Despite this, their editors operate largely without formal training or certification. To our knowledge, no body of literature systematically identifying core competencies for scientific editors of biomedical journals exists. Therefore, we aimed to conduct a scoping review to determine what is known on the competency requirements for scientific editors of biomedical journals.MethodsWe searched the MEDLINE®, Cochrane Library, Embase®, CINAHL, PsycINFO, and ERIC databases (from inception to November 2014) and conducted a grey literature search for research and non-research articles with competency-related statements (i.e. competencies, knowledge, skills, behaviors, and tasks) pertaining to the role of scientific editors of peer-reviewed health-related journals. We also conducted an environmental scan, searched the results of a previous environmental scan, and searched the websites of existing networks, major biomedical journal publishers, and organizations that offer resources for editors.ResultsA total of 225 full-text publications were included, 25 of which were research articles. We extracted a total of 1,566 statements possibly related to core competencies for scientific editors of biomedical journals from these publications. We then collated overlapping or duplicate statements which produced a list of 203 unique statements. Finally, we grouped these statements into seven emergent themes: (1) dealing with authors, (2) dealing with peer reviewers, (3) journal publishing, (4) journal promotion, (5) editing, (6) ethics and integrity, and (7) qualities and characteristics of editors.DiscussionTo our knowledge, this scoping review is the first attempt to systematically identify possible competencies of editors. Limitations are that (1) we may not have captured all aspects of a biomedical editor’s work in our searches, (2) removing redundant and overlapping items may have led to the elimination of some nuances between items, (3) restricting to certain databases, and only French and English publications, may have excluded relevant publications, and (4) some statements may not necessarily be competencies.ConclusionThis scoping review is the first step of a program to develop a minimum set of core competencies for scientific editors of biomedical journals which will be followed by a training needs assessment, a Delphi exercise, and a consensus meeting.

Athlete's foot and fungally infected toenails

Background Definition Athlete9s foot is a cutaneous fungal infection that causes the skin to itch, flake, and fissure. Nail involvement is characterised by ungual thickening and discoloration. Incidence/prevalence: In the United Kingdom, athlete9s foot is present in about 15% of the general population,1 and 1.2 million people have fungally infected toenails.2 Aetiology/risk factors: Swimming pool users and industrial workers may have increased risk of fungal foot infection. However, one survey found fungal foot infection in only 8.5% of swimmers, with the highest incidence (20%) in men aged 16 years and over.1 Prognosis: Fungal infections of the foot are not life threatening in people with normal immunity, but in some people they cause persistent symptoms. Other people seem to be oblivious of persistent infection. The infection can spread to other parts of the body and to other people. Aims: To control symptoms and prevent recurrence, with minimal adverse effects. Outcomes: Rates of fungal eradication, shown by negative microscopy and culture, and resolution of clinical signs and symptoms at follow up.

Support surfaces for treating pressure injury: A Cochrane systematic review

OBJECTIVES To examine the effects on healing of pressure relieving support surfaces in the treatment of pressure injury. DESIGN Systematic review. DATA SOURCES Cochrane Wound Group Specialised Register, The Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Ovid EMBASE and EBSCO CINAHL. The reference sections of included trials were searched for further trials. REVIEW METHODS Randomised controlled trials, published or unpublished, assessing the effect of support surfaces in treating all pressure injuries were sought. All included studies had to have reported objective measures of pressure injury healing. Where possible, findings from individual trials were calculated using risk ratio estimates or mean difference with 95% confidence intervals. RESULTS Eighteen eligible trials involving 1309 participants were identified. There was no statistically significant effect on pressure injury size with low air loss devices compared with foam alternatives. One small trial at high risk of bias found that sheepskin positioned under the legs significantly reduced redness and a very small subgroup analysis favoured a profiling bed when compared with a standard bed in terms of the healing of grade 1 pressure injuries. CONCLUSIONS Overall, there was an absence of good evidence to support the superiority of any pressure relieving device in the treatment of pressure injuries. This review highlights that the current evidence base requires improving by undertaking robust trials to ascertain which support surfaces are most effective for the treatment of pressure injuries.

Core Competencies for Scientific Editors of Biomedical Journals: Consensus Statement

BackgroundScientific editors are responsible for deciding which articles to publish in their journals. However, we have not found documentation of their required knowledge, skills, and characteristics, or the existence of any formal core competencies for this role.MethodsWe describe the development of a minimum set of core competencies for scientific editors of biomedical journals.ResultsThe 14 key core competencies are divided into three major areas, and each competency has a list of associated elements or descriptions of more specific knowledge, skills, and characteristics that contribute to its fulfillment.ConclusionsWe believe that these core competencies are a baseline of the knowledge, skills, and characteristics needed to perform competently the duties of a scientific editor at a biomedical journal.