Poor description of non-pharmacological interventions: analysis of consecutive sample of randomised trials.

OBJECTIVES: To evaluate the completeness of descriptions of non-pharmacological interventions in randomised trials, identify which elements are most frequently missing, and assess whether authors can provide missing details. DESIGN: Analysis of consecutive sample of randomised trials of non-pharmacological interventions. DATA SOURCES AND STUDY SELECTION: All reports of randomised trials of non-pharmacological interventions published in 2009 in six leading general medical journals; 133 trial reports, with 137 interventions, met the inclusion criteria. DATA COLLECTION: Using an eight item checklist, two raters assessed the primary full trial report, plus any reference materials, appendices, or websites. Questions about missing details were emailed to corresponding authors, and relevant items were then reassessed. RESULTS: Of 137 interventions, only 53 (39%) were adequately described; this was increased to 81 (59%) by using 63 responses from 88 contacted authors. The most frequently missing item was the "intervention materials" (47% complete), but it also improved the most after author response (92% complete). Whereas some authors (27/70) provided materials or further information, other authors (21/70) could not; their reasons included copyright or intellectual property concerns, not having the materials or intervention details, or being unaware of their importance. Although 46 (34%) trial interventions had further information or materials readily available on a website, many were not mentioned in the report, were not freely accessible, or the URL was no longer functioning. CONCLUSIONS: Missing essential information about interventions is a frequent, yet remediable, contributor to the worldwide waste in research funding. If trial reports do not have a sufficient description of interventions, other researchers cannot build on the findings, and clinicians and patients cannot reliably implement useful interventions. Improvement will require action by funders, researchers, and publishers, aided by long term repositories of materials linked to publications.

The scatter of research: cross sectional comparison of randomised trials and systematic reviews across specialties.

OBJECTIVE: To estimate the degree of scatter of reports of randomised trials and systematic reviews, and how the scatter differs among medical specialties and subspecialties. DESIGN: Cross sectional analysis. DATA SOURCE: PubMed for all disease relevant randomised trials and systematic reviews published in 2009. STUDY SELECTION: Randomised trials and systematic reviews of the nine diseases or disorders with the highest burden of disease, and the broader category of disease to which each belonged. RESULTS: The scatter across journals varied considerably among specialties and subspecialties: otolaryngology had the least scatter (363 trials across 167 journals) and neurology the most (2770 trials across 896 journals). In only three subspecialties (lung cancer, chronic obstructive pulmonary disease, hearing loss) were 10 or fewer journals needed to locate 50% of trials. The scatter was less for systematic reviews: hearing loss had the least scatter (10 reviews across nine journals) and cancer the most (670 reviews across 279 journals). For some specialties and subspecialties the papers were concentrated in specialty journals; whereas for others, few of the top 10 journals were a specialty journal for that area. Generally, little overlap occurred between the top 10 journals publishing trials and those publishing systematic reviews. The number of journals required to find all trials or reviews was highly correlated (r = 0.97) with the number of papers for each specialty/subspecialty. CONCLUSIONS: Publication rates of speciality relevant trials vary widely, from one to seven trials per day, and are scattered across hundreds of general and specialty journals. Although systematic reviews reduce the extent of scatter, they are still widely scattered and mostly in different journals to those of randomised trials. Personal subscriptions to journals, which are insufficient for keeping up to date with knowledge, need to be supplemented by other methods such as journal scanning services or systems that cover sufficient journals and filter articles for quality and relevance. Few current systems seem adequate.

Do you think it's a disease? a survey of medical students.

BACKGROUND: The management of medical conditions is influenced by whether clinicians regard them as "disease" or "not a disease". The aim of the survey was to determine how medical students classify a range of conditions they might encounter in their professional lives and whether a different name for a condition would influence their decision in the categorisation of the condition as a 'disease' or 'not a disease'. METHODS: We surveyed 3 concurrent years of medical students to classify 36 candidate conditions into "disease" and "non-disease". The conditions were given a 'medical' label and a (lay) label and positioned where possible in alternate columns of the survey. RESULTS: The response rate was 96% (183 of 190 students attending a lecture): 80% of students concurred on 16 conditions as "disease" (eg diabetes, tuberculosis), and 4 as "non-disease" (eg baldness, menopause, fractured skull and heat stroke). The remaining 16 conditions (with 21-79% agreement) were more contentious (especially obesity, infertility, hay fever, alcoholism, and restless leg syndrome). Three pairs of conditions had both a more, and a less, medical label: the more medical labels (myalgic encephalomyelitis, hypertension, and erectile dysfunction) were more frequently classified as 'disease' than the less medical (chronic fatigue syndrome, high blood pressure, and impotence), respectively, significantly different for the first two pairs. CONCLUSIONS: Some conditions excluded from the classification of "disease" were unexpected (eg fractured skull and heat stroke). Students were mostly concordant on what conditions should be classified as "disease". They were more likely to classify synonyms as 'disease' if the label was medical. The findings indicate there is still a problem 30 years on in the concept of 'what is a disease'. Our findings suggest that we should be addressing such concepts to medical students.