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Background

Obstructive apnea is a sleep disorder characterized by pauses in breathing during sleep: breathing is interrupted by a physical block to airflow despite effort. The purpose of this study was to test if osteopathy could influence the incidence of obstructive apnea during sleep in infants.

Methods

Thirty-four healthy infants (age: 1.5–4.0 months) were recruited and randomized in two groups; six infants dropped out. The osteopathy treatment group (n = 15 infants) received 2 osteopathic treatments in a period of 2 weeks and a control group (n = 13 infants) received 2 non-specific treatments in the same period of time. The main outcome measure was the change in the number of obstructive apneas measured during an 8-hour polysomnographic recording before and after the two treatment sessions.

Results

The results of the second polysomnographic recordings showed a significant decrease in the number of obstructive apneas in the osteopathy group (p = 0.01, Wilcoxon test), in comparison to the control group showing only a trend suggesting a gradual physiologic decrease of obstructive apneas. However, the difference in the decline of obstructive apneas between the groups after treatment was not significant (p = 0.43).

Conclusion

Osteopathy may have a positive influence on the incidence of obstructive apneas during sleep in infants with a previous history of obstructive apneas as measured by polysomnography. Additional research in this area appears warranted.

Background

Well managed diabetes requires active self-management in order to ensure optimal glycaemic control and appropriate use of available clinical services and other supports. Peer supporters can assist people with their daily diabetes self-management activities, provide emotional and social support, assist and encourage clinical care and be available when needed.

Methods

A national database of Australians diagnosed with type 2 diabetes is being used to invite people in pre-determined locations to participate in community-based peer support groups. Peer supporters are self-identified from these communities. All consenting participants receive diabetes self-management education and education manual prior to randomization by community to a peer support intervention or usual care. This multi-faceted intervention comprises four interconnected components for delivering support to the participants. (1) Trained supporters lead 12 monthly group meetings. Participants are assisted to set goals to improve diabetes self-management, discuss with and encourage each other to strengthen linkages with local clinical services (including allied health services) as well as provide social and emotional support. (2) Support through regular supporter-participant or participant-participant contact, between monthly sessions, is also promoted in order to maintain motivation and encourage self-improvement and confidence in diabetes self-management. (3) Participants receive a workbook containing diabetes information, resources and community support services, key diabetes management behaviors and monthly goal setting activity sheets. (4) Finally, a password protected website contains further resources for the participants. Supporters are mentored and assisted throughout the intervention by other supporters and the research team through attendance at a weekly teleconference. Data, including a self-administered lifestyle survey, anthropometric and biomedical measures are collected on all participants at baseline, 6 and 12 months. The primary outcome is change in cardiovascular disease risk using the UKPDS risk equation. Secondary outcomes include biomedical, quality of life, psychosocial functioning, and other lifestyle measures. An economic evaluation will determine whether the program is cost effective.

Discussion

This manuscript presents the protocol for a cluster randomized controlled trial of group-based peer support for people with type 2 diabetes in a community setting. Results from this trial will contribute evidence about the effectiveness of peer support in achieving effective self-management of diabetes.

Trial registration number

Australian New Zealand Clinical Trials Registry (ANZCTR); ACTRN12609000469213

Controversy continues on whether or not ionizing radiation is harmful at low doses, with unresolved scientific uncertainty about effects below a few tens of millisieverts. To settle what regulatory controls should apply in this dose region, an assumption has to be made relating dose to the possibility of harm or benefit. The position of the Australasian Radiation Protection Society on this matter is set out in a statement adopted by the Society in 2005. Its salient features are: •There is insufficient evidence to establish a dose-effect relationship for doses that are less than a few tens of millisieverts in a year. A linear extrapolation from higher dose levels should be assumed only for the purpose of applying regulatory controls.• Estimates of collective dose arising from individual doses that are less than some tens of millisieverts in a year should not be used to predict numbers of fatal cancers.•The risk to an individual of doses significantly less than 100 microsieverts in a year is so small, if it exists at all, that regulatory requirements to control exposure at this level are not warranted.

Background

Researchers from the developing world contribute only a limited proportion to the total research output published in leading medical education journals. Some of them believe that there is a substantial editorial bias against their work. To obtain an objective basis for further discussion the present study was designed to assess the composition of the editorial boards of leading medical education journals.

Methods

The editorial boards of the three leading medical education journals according to their impact factor were retrieved from the respective January issue of the year 2003. We evaluated in which countries the editorial board members were based and classified these countries using the World Bank income criteria.

Results

Individuals from a number of countries can be found on the editorial boards of the investigated journals, but most of them are based in high-income countries.

Conclusion

The percentage of editorial board members which are based in developing world countries is higher for the leading medical education journals than in most of their psychiatry and general medicine counterparts. But it is still too low.

OBJECTIVE--To determine whether two adults with stress fractures receiving low weekly doses of methotrexate had methotrexate osteopathy. CASE REPORTS--Two adult patients developed features consistent with methotrexate osteopathy while receiving low weekly doses of methotrexate. METHODS--Iliac crest biopsy samples were taken and bone histomorphometry carried out. RESULTS--Symptoms resolved when the methotrexate was discontinued. Bone histology showed changes consistent with osteoblast inhibition by methotrexate. CONCLUSIONS--When given in low doses for prolonged periods, methotrexate may have adverse effects on bone, particularly in post-menopausal women.

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In keeping with its promise to evolve in response to the needs of readers, Genome Biology is making a number of practical changes with the beginning of 2003.

As a new year begins, it is a good time to review developments of the past twelve months and to announce some changes in GSE for 2007. Since November 2005, GSE has received 122 new manuscripts, accepted 42 articles (of which 19 were submitted before November 2005) and still has 32 manuscripts in evaluation. Thus the number of submitted manuscripts is constantly increasing while the number of published articles is maintained at around 40 per year. Published articles originate from 15 countries with Spain leading (10), followed by the USA (5), Australia, France and Germany (4 each), UK (3), China, Denmark and Finland (2 each) and finally, Brazil, Canada, Greece, Japan, Norway and Slovenia. Of these 42 published papers, 19 deal with methodologies of quantitative genetics and their applications to animal selection and characterization, six address genetic diversity of populations and breeds and seven fall in the field of molecular genetics. These figures clearly show that GSE is attractive to the animal quantitative genetics community and has acquired a strong experience and reputation in this domain.

To answer this increasing demand, we have asked two new associate editors to join our editorial panel and are pleased that they have agreed: Denis Couvet from the Muséum National d'Histoire Naturelle (France) specialized in conservation biology and population genetics and Frédéric Farnir from the University of Liège (Belgium) whose research interests focus on the genetic and functional study of QTL involved in agricultural traits.

In this editorial note, we also wish to inform you about our misfortune with the calculation of the 2005 Impact Factor published in June 2006 in the "Journal of Citation Reports" by Thompson Scientific. Based on our calculations, the published 2005 IF 1.62 turned out to be erroneous and in disfavour of GSE, which Thompson Scientific has acknowledged. The true 2005 IF is 1.783 and thus, GSE occupies the 5th position in the section "Agriculture, Dairy & Animal Science" and the 82nd in the section "Genetics & Heredity". Corrections in JCR have been done in October 2006.

Finally, GSE and EDP Sciences wish to keep up with the rapid changes of publication systems, i.e. the advent of "Open Access" publishing, to make scientific research widely and freely available. Thus, we are happy to announce that as a first step in this direction, GSE now gives the possibility to authors to choose how they want their paper to be published by offering the "Open Choice" option. With this option, authors can have their articles accepted for publication made available to all interested readers (subscribers or non-subscribers) as soon as they are on-line in exchange of a basic fee, i.e. 550 euros for papers published in 2007 (without VAT).

With all this news, we offer the collaborators, authors and readers of GSE our season greetings and best wishes for a successful and productive New Year 2007.

Although Canadian health care reform has constrained costs and improved efficiency, it has had a profound and mixed effect on Canadian academic medicine. Teaching hospitals have been reduced in number and size, and in patient programs have shifted to ambulatory and community settings. Specialized care programs are now multi-institutional and multidisciplinary. Furthermore, the influence of regional planning bodies has grown markedly. Although these changes have likely improved clinical service, their impact on the quality of clinical education is uncertain. Within the academic clinical department, recruitment of young faculty has been greatly complicated by constraints on licensing, billing numbers, fee-for-service income and research funding. The departmental practice plan based on university funds and fee-for-service income is being replaced by less favourable funding arrangements. However, emphasis on multidisciplinary programs has rendered these departments more flexible in structure. The future of Canadian academic medicine depends on an effective alliance with government. Academia and government must agree, particularly on human-resource requirements, research objectives and the delivery of clinical and academic programs in regional and community settings. The establishment of focal points for academic health sciences planning within academic health sciences centres and within governments would assist in these developments. Finally, government and the academic health sciences sector must work together to remove the current impediments to the recruitment of highly qualified young faculty.

Many factors are weighed in judging the quality of a journal. Editorial policies in the instructions to authors section offer an important, though often neglected, source of information. In addition to directions on formatting and style, this section often includes financial disclosures and policies on coverage, peer review, confidentiality, human experimentation and duplicate submissions. This study analyzes the contents of instructions sections from several categories of medical journals to determine their usefulness in making collection development decisions. Included are journals currently considered the most prestigious, indexed in Index Medicus and Abridged Index Medicus, and not indexed in Index Medicus or subscribed to by a typical large academic health sciences library. It was found that in a statistically significant number of journals, the instructions to authors section is more likely to be included and substantive in highly regarded journals than in less prestigious journals. It is concluded that the amount of information in the instructions section is related to the quality of the journal and that these sections are a useful collection development tool.

This editorial introduces the new online, open access, peer-reviewed journal Trials. The journal considers manuscripts on any aspect of the design, performance, and findings of randomised controlled trials in any discipline related to health care, and also encourages the publication of protocols. Trialists will be able to provide the necessary detail for a true and complete scientific record. They will be able to communicate not only all outcome measures, as well as varying analyses and interpretations, but also in-depth descriptions of what they did and honest reflections about what they learnt.

Trials also encourages articles covering generic issues related to trials, for example focussing on the design, conduct, analysis, interpretation, or reporting.

Alternative hypotheses in higher-level marsupial systematics have different implications for marsupial origins, character evolution, and biogeography. Resolving the position of the South American monito del monte (Order Microbiotheria) is of particular importance in that alternate hypotheses posit sister-group relationships between microbiotheres and taxa with disparate temporal and geographic distributions: pediomyids; didelphids; dasyuromorphians; diprotodontians; all other australidelphians; and all other marsupials. Among Australasian marsupials, the placement of bandicoots is critical; competing views associate bandicoots with particular Australasian taxa (diprotodontians, dasyuromorphians) or outside of a clade that includes all other Australasian forms and microbiotheres. Affinities of the marsupial mole are also unclear. The mole is placed in its own order (Notoryctemorphia) and sister-group relationships have been postulated between it and each of the other Australasian orders. We investigated relationships among marsupial orders by using a data set that included mitochondrial and nuclear genes. Phylogenetic analyses provide support for the association of microbiotheres with Australasian marsupials and an association of the marsupial mole with dasyuromorphs. Statistical tests reject the association of diprotodontians and bandicoots together as well as the monophyly of Australasian marsupials. The origin of the paraphyletic Australasian marsupial fauna may be accounted for by (i) multiple entries of australidelphians into Australia or (ii) bidirectional dispersal of australidelphians between Antarctica and Australia.

Objective: The research analyzes usage of a major biomedical library's pre-1993 print journal collection.

Methodology: In July 2003, in preparation for a renovation and expansion project, the Biomedical Library at the University of California, San Diego, moved all of its pre-1993 journal volumes off-site, with the exception of twenty-two heavily used titles. Patrons wishing to consult one of these stored volumes could request that it be delivered to the library for their use. In the spring of 2006, an analysis was made of these requests.

Results: By July of 2006, 79,827 journal volumes published in 1992 or earlier had been requested from storage. The number of requests received declined with age of publication. The usage distribution exhibited a “long tail”: 50% of the 79,827 requests were for journal volumes published before 1986. The availability of electronic access dramatically reduced the chance that corresponding print journal volumes would be requested.

Conclusions: The older biomedical print journal literature appears to be of continued value to the biomedical research community. When electronic access was provided to the older literature, demand for older print volumes declined dramatically.

PURPOSE: Membership on a professional medical society or journal editorial board is a marker of influence and prestige for those in academic medicine. This study presents the first comprehensive quantification of women on these boards and the implications for women in medicine. METHODS: The numbers of women and men on professional society and journal editorial boards across 28 specialties (March 2004) were counted. The number of women holding multiple roles on these boards and the number of women holding top leadership positions on these boards were counted, and these proportions were compared. RESULTS: Three-thousand-four-hundred-seventy-three individuals on 39 professional medical society boards and 54 journal editorial boards were included. Eighty-three percent (2,884) of board members were male. Men occupied > 80% of top leadership positions on these boards. Thirty-five of the 589 women in the study held multiple roles. Anesthesiology (p < 0.0025), pediatrics (p < 0.0001), dermatology (p = 0.0001), obstetrics/ gynecology (p = 0.05), medical genetics (p < 0.015) and rehabilitation medicine (p < 0.03) had significantly lower proportions of women on boards in comparison to the total women in the specialty. Internal medicine, plastic surgery, cardiology and general surgery had nearly equivalent proportions; in otolaryngology and family medicine, female board members slightly exceeded the proportion of women in the field. CONCLUSION: Women's representation on society and editorial boards does not always reflect their presence in medical specialties, and it is critically lacking in certain specialties. Efforts should be made to attain parity of women leaders on these boards. Further efforts should be made to eliminate barriers to women's leadership in medicine.

Debate continues as to the usefulness of assessing adenomas for loss of mismatch repair protein expression to identify individuals with suspected Lynch syndrome. We tested 109 polyps from 69 proven mutation carriers (35 females and 34 males) belonging to 49 Lynch syndrome families. All polyps were tested by immunohistochemistry for four mismatch repair proteins MLH1, MSH2, MSH6 and PMS2. Detailed pathology review was performed by specialist gastrointestinal pathologists. The majority of polyps (86%) were conventional adenomas (n = 94), with 65 tubular and 28 tubulovillous adenomas and a single villous adenoma. The remaining 15 lesions (14%) were serrated polyps. Overall, loss of mismatch repair expression was noted for 78/109 (72%) of polyps. Loss of mismatch repair expression was seen in 74 of 94 (79%) conventional adenomas, and 4/15 (27%) serrated polyps from mismatch repair gene mutation carriers. In all instances, loss of expression was consistent with the underlying germline mutation. mismatch repair protein expression was lost in 27 of 29 adenomas with a villous component compared with 47 of 65 adenomas without this feature (93% vs 73%; p=0.028). A strong trend was observed for high-grade dysplasia. mismatch repair deficiency was observed in 12 of 12 conventional adenomas with high-grade dysplasia compared with 60 of 79 with low grade dysplasia (100% vs 76%; p=0.065). We were unable to demonstrate a significant association between conventional adenoma size or site and mismatch repair deficiency. All (4/4 or 100%) of the serrated polyps demonstrating mismatch repair deficiency were traditional serrated adenomas from a single family. Diagnostic testing of adenomas in suspected Lynch syndrome families is a useful alternative in cases where cancers are unavailable. The overwhelming majority of conventional adenomas from mutation carriers show loss of mismatch repair protein expression concordant with the underlying germline mutation.

Australian stiletto flies of the sister-genera Acupalpa Kröber, 1912 and Pipinnipons Winterton, 2001 (Diptera: Therevidae: Agapophytinae) are revised. Twelve new species of Acupalpa are described, while Acupalpa imitans (White, 1915), comb. n. is transferred from Pipinnipons and Acupalpa albimanis (Kröber, 1914), comb. n. is transferred from Ectinorhynchus Macquart as a senior synonym of Acupalpa pollinosa Mann. The total number of species of Acupalpa is therefore increased to 19: Acupalpa albimanis (Kröber), comb. n., Acupalpa albitarsa Mann, Acupalpa boharti sp. n., Acupalpa divisa (Walker), Acupalpa dolichorhyncha sp. n., Acupalpa glossa sp. n., Acupalpa imitans (White), comb. n., Acupalpa irwini Winterton, Acupalpa melanophaeos sp. n., Acupalpa miaboolya sp. n., Acupalpa minuta sp. n., Acupalpa minutoides sp. n., Acupalpa notomelas sp. n., Acupalpa novayamarna sp. n., Acupalpa rostrata Kröber, Acupalpa semirufa Mann, Acupalpa westralica sp. n., Acupalpa yalgoo sp. n. and Acupalpa yanchep sp. n. Three new species of Pipinnipons are described, increasing the total number of species to five: Pipinnipons chauncyvallis sp. n., Pipinnipons fascipennis (Kröber), Pipinnipons kampmeierae sp. n., Pipinnipons kroeberi Winterton, and P. sphecoda sp. n. Pipinnipons and Acupalpa are rediagnosed in light of the new species presented herein and revised keys to species are included. A dichotomous key to genera of Australasian Therevidae is included. As an empirical example of cybertaxonomy, taxonomic descriptions were composed using a character matrix developed in Lucid Builder (in Structured Descriptive Data (SDD) format) to generate natural language descriptions supplemented by online specimen and image databases. Web resources are provided throughout the document including: a) links to high resolution colour images of all species on Morphbank, b) registration of authors, publications, taxon names and other nomenclatural acts in Zoobank, with assignment of Life Science Identifiers (LSIDs) for each, c) links to Genbank accession records for DNA sequences, and d) assignment of LSIDs to specimen records with links to respective records in an online Therevidae specimen database.

The Australasian spider flies (Diptera: Acroceridae) are reviewed, with all eight currently recognized genera diagnosed and figured. The panopine genus Panops Lamarck, 1804 from Australia and Indonesia is revised with four new species described, increasing the total number of species in the genus to nine: Panops aurum sp. n., Panops danielsi sp. n., Panops jade sp. n. and Panops schlingeri sp. n. Five species of Panops are redescribed: Panops austrae Neboiss, 1971, Panops baudini Lamarck, 1804, Panops boharti (Schlinger, 1959), comb. n., Panops conspicuus (Brunetti, 1926) and Panops grossi (Neboiss, 1971), comb. n. The monotypic genera Neopanops Schlinger, 1959 and Panocalda Neboiss, 1971 are synonymized with Panops. Keys to genera of Australasian Acroceridae and species of Panops, Helle Osten Sacken, 1896 and Australasian Pterodontia Gray, 1832 are included.

The development of regional databases and doctors’ desktop programs that accept pathology results from different laboratories should improve patient care by allowing easy assessment of cumulative data. This has the potential to be unnecessarily confusing unless laboratories contributing to the databases provide standardised results and common reference intervals, where this is valid. The analytical methods that produce significantly different results need to be reported in a manner that avoids inappropriate interpretation.

The process of setting reference intervals requires an organisational structure which enables appropriate intervals to be set taking all relevant factors into account, including the opinions of expert clinicians. There must also be criteria for analytical agreement between the laboratories involved based on comparison studies using patient samples.

A network of QA groups across Australasia, with leadership from the AACB and RCPA, should be formed to share the ongoing work of defining reference intervals (RIs) for common tests, and reviewing them as the testing environment changes with the introduction of new techniques and instruments.

Background

One of the most widely accepted ecomorphological relationships in vertebrates is the negative correlation between intestinal length and proportion of animal prey in diet. While many fish groups exhibit this general pattern, other clades demonstrate minimal, and in some cases contrasting, associations between diet and intestinal length. Moreover, this relationship and its evolutionary derivation have received little attention from a phylogenetic perspective. This study documents the phylogenetic development of intestinal length variability, and resultant correlation with dietary habits, within a molecular phylogeny of 28 species of terapontid fishes. The Terapontidae (grunters), an ancestrally euryhaline-marine group, is the most trophically diverse of Australia’s freshwater fish families, with widespread shifts away from animal-prey-dominated diets occurring since their invasion of fresh waters.

Results

Description of ontogenetic development of intestinal complexity of terapontid fishes, in combination with ancestral character state reconstruction, demonstrated that complex intestinal looping (convolution) has evolved independently on multiple occasions within the family. This modification of ontogenetic development drives much of the associated interspecific variability in intestinal length evident in terapontids. Phylogenetically informed comparative analyses (phylogenetic independent contrasts) showed that the interspecific differences in intestinal length resulting from these ontogenetic developmental mechanisms explained ~65% of the variability in the proportion of animal material in terapontid diets.

Conclusions

The ontogenetic development of intestinal complexity appears to represent an important functional innovation underlying the extensive trophic differentiation seen in Australia’s freshwater terapontids, specifically facilitating the pronounced shifts away from carnivorous (including invertebrates and vertebrates) diets evident across the family. The capacity to modify intestinal morphology and physiology may also be an important facilitator of trophic diversification during other phyletic radiations.

Context

In July 2006, a lasting and severe heat wave occurred in Western Europe. Since the2003 heat wave, several preventive measures and an alert system aiming at reducing the risks related to high temperatures have been set up in France by the health authorities and institutions. In order to evaluate the effectiveness of those measures, the observed excess mortality during the 2006 heat wave was compared to the expected excess mortality.

Methods

A Poisson regression model relating the daily fluctuations in summer temperature and mortality in France from 1975 to 2003 was used to estimate the daily expected number of deaths over the period 2004–2006 as a function of the observed temperatures.

Results

During the 2006 heat wave (from 11th to 28th July), about 2065 excess deaths occurred in France. Considering the observed temperatures and with the hypothesis that heat-related mortality had not changed since 2003, 6452 excess deaths were predicted for the period. The observed mortality during the 2006 heat wave was thus markedly less than the expected mortality (approximately 4400 less deaths).

Conclusions

The excess mortality during the 2006 heat wave, which was markedly lower than that predicted by the model, may be interpreted as a decrease in the population’s vulnerability to heat, together with, since 2003, increased awareness of the risk related to extreme temperatures, preventive measures and the set-up of the warning system.

Case description

We evaluated the effects of integrating order subsets for the most common medical diagnoses into a general medical admission order set of our electronic medical records (EMR) in order to improve order set integration by clinicians.

Methods of implementation

We identified the most common primary and secondary diagnoses for patients admitted to our medical service and developed order subsets comprising only of the orders necessary for the management of these individual diagnoses. Using the capabilities of our computerized physician order entry (CPOE), we nested these order subsets into the general order set and evaluated the resulting change in order set utilization by our clinicians.

Example and observations

The total number of order sets used by clinicians in all departments increased fivefold during the 16-month period following the implementation of the integrated order sets in July 2008. A before and after time series was used to analyze the trend in increased order set usage and showed an effect of the intervention (p=0.023).

Discussion

Integration of disease specific order subsets into a single general admission order set significantly improved the overall adoption of order sets by clinicians. This provides health care systems with the opportunity to improve patient safety and implement evidence based care in clinical practice.

Background

Editorial peer review is universally used but little studied. We examined the relationship between external reviewers' recommendations and the editorial outcome of manuscripts undergoing external peer-review at the Journal of General Internal Medicine (JGIM).

Methodology/Principal Findings

We examined reviewer recommendations and editors' decisions at JGIM between 2004 and 2008. For manuscripts undergoing peer review, we calculated chance-corrected agreement among reviewers on recommendations to reject versus accept or revise. Using mixed effects logistic regression models, we estimated intra-class correlation coefficients (ICC) at the reviewer and manuscript level. Finally, we examined the probability of rejection in relation to reviewer agreement and disagreement. The 2264 manuscripts sent for external review during the study period received 5881 reviews provided by 2916 reviewers; 28% of reviews recommended rejection. Chance corrected agreement (kappa statistic) on rejection among reviewers was 0.11 (p<.01). In mixed effects models adjusting for study year and manuscript type, the reviewer-level ICC was 0.23 (95% confidence interval [CI], 0.19–0.29) and the manuscript-level ICC was 0.17 (95% CI, 0.12–0.22). The editors' overall rejection rate was 48%: 88% when all reviewers for a manuscript agreed on rejection (7% of manuscripts) and 20% when all reviewers agreed that the manuscript should not be rejected (48% of manuscripts) (p<0.01).

Conclusions/Significance

Reviewers at JGIM agreed on recommendations to reject vs. accept/revise at levels barely beyond chance, yet editors placed considerable weight on reviewers' recommendations. Efforts are needed to improve the reliability of the peer-review process while helping editors understand the limitations of reviewers' recommendations.

Chiropractic & Osteopathy changes its title to Chiropractic & Manual Therapies in January 2011. This change reflects the expanding base of submissions from clinical scientists interested in the discipline of manual therapy. It is also in accord with the findings of a review of the journal content and a joint venture between the original parent organisation the Chiropractic and Osteopathic College of Australasia and a new partner the European Academy of Chiropractic, which is a subsidiary body of the European Chiropractors' Union. The title change should encourage submissions from all professionals interested in manual therapy including chiropractors, osteopaths, physiotherapists, medical doctors and scientists interested in this field.

Back pain is a common problem in general practice, and is of enormous economic importance. A recent report urges general practitioners (GPs) to refer early for manual therapies, such as osteopathy. The key concept to understanding osteopathic principles is somatic dysfunction. This is a disorder of function, rather than pathology, of the musculoskeletal and related systems. Its characteristic features are asymmetry of anatomical landmarks, asymmetry of joint movement, tissue texture changes, and tenderness. The scientific basis of the tissue texture changes and tenderness can be explained in terms of the 'facilitated segment', but the cause of movement asymmetry remains elusive. Randomized controlled trials provide some support for the use of osteopathic treatment in acute low back pain. It is proposed that somatic dysfunction is the new paradigm for non-specific back pain.

Background

In 2004, a review of pilot studies published in seven major medical journals during 2000-01 recommended that the statistical analysis of such studies should be either mainly descriptive or focus on sample size estimation, while results from hypothesis testing must be interpreted with caution. We revisited these journals to see whether the subsequent recommendations have changed the practice of reporting pilot studies. We also conducted a survey to identify the methodological components in registered research studies which are described as 'pilot' or 'feasibility' studies. We extended this survey to grant-awarding bodies and editors of medical journals to discover their policies regarding the function and reporting of pilot studies.

Methods

Papers from 2007-08 in seven medical journals were screened to retrieve published pilot studies. Reports of registered and completed studies on the UK Clinical Research Network (UKCRN) Portfolio database were retrieved and scrutinized. Guidance on the conduct and reporting of pilot studies was retrieved from the websites of three grant giving bodies and seven journal editors were canvassed.

Results

54 pilot or feasibility studies published in 2007-8 were found, of which 26 (48%) were pilot studies of interventions and the remainder feasibility studies. The majority incorporated hypothesis-testing (81%), a control arm (69%) and a randomization procedure (62%). Most (81%) pointed towards the need for further research. Only 8 out of 90 pilot studies identified by the earlier review led to subsequent main studies. Twelve studies which were interventional pilot/feasibility studies and which included testing of some component of the research process were identified through the UKCRN Portfolio database. There was no clear distinction in use of the terms 'pilot' and 'feasibility'. Five journal editors replied to our entreaty. In general they were loathe to publish studies described as 'pilot'.

Conclusion

Pilot studies are still poorly reported, with inappropriate emphasis on hypothesis-testing. Authors should be aware of the different requirements of pilot studies, feasibility studies and main studies and report them appropriately. Authors should be explicit as to the purpose of a pilot study. The definitions of feasibility and pilot studies vary and we make proposals here to clarify terminology.

Background

According to the original model of cranial osteopathy, intrinsic rhythmic movements of the human brain cause rhythmic fluctuations of cerebrospinal fluid and specific relational changes among dural membranes, cranial bones, and the sacrum. Practitioners believe they can palpably modify parameters of this mechanism to a patient's health advantage.

Discussion

This treatment regime lacks a biologically plausible mechanism, shows no diagnostic reliability, and offers little hope that any direct clinical effect will ever be shown. In spite of almost uniformly negative research findings, "cranial" methods remain popular with many practitioners and patients.

Summary

Until outcome studies show that these techniques produce a direct and positive clinical effect, they should be dropped from all academic curricula; insurance companies should stop paying for them; and patients should invest their time, money, and health elsewhere.