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1.  Osteopathy may decrease obstructive apnea in infants: a pilot study 
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.
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.
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).
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.
PMCID: PMC2500035  PMID: 18638410
2.  Composition of the editorial boards of leading medical education journals 
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.
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.
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.
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.
PMCID: PMC331408  PMID: 14733618
3.  Tolerability of intravenous pamidronate for the treatment of osteoporosis and other metabolic osteopathies: A retrospective analysis 
Background: Intravenous disodium pamidronate has been described in the treatment of several osteopathies. Although tolerability has been found to be good in clinical trials, some mild to serious adverse events (AEs) have been reported.
Objectives: The aims of this study were to analyze the toelrability of IV pamidronate in patients being treated for osteoporosis and other metabolic osteopathies and to describe particular patients with relative contraindications, because such cases are not commonly seen in daily clinical practice.
Methods: We performed a retrospective analysis of patients with different osteopathies who were administered IV infusions of pamidronate at doses ranging from 15 to 90 mg/infusion and 15 to 900 mg/year. The study was conducted in patients who had received treatment at the Institute of Metabolic Investigations, University of Salvador, Buenos Aires, Argentina, between January 1995 and December 2003. To rule out dose-related AEs, a comparison was made between patients who received fewer IV infusions and had cumulative doses of 120 to 180 mg/y (less frequent administration [LFA] group) and those patients who received regular infusions and had cumulative doses of >180 mg/year (frequent administration [FA] group). To confirm data obtained from medical records and to assess the occurrence of AEs, attempts were made to interview all patients by phone. The following information was verified for each patient included in the study: the reason for treatment, documented evidence of current diagnostic criteria, and whether the dose administered was adequate to treat the patient's condition.
Results: Six hundred eight patients (464 [76.3%]women, 144 [23.7%]men; mean [SD] age, 69 [10] years) with various osteopathies (osteoporosis, 367 [60.4%] of the patients; Paget's disease, 172 [28.3%]; Sudeck's disease, 63 [10.4%]; multiple myeloma, 3 [0.5%]; and bone metastases, 3 [0.5%]) were administered a total of 2933 IV infusions of pamidronate during the study period. We were able to confirm the clinical records of 69.4% (422/608) of the patients by telephone survey; 29.9% (124/415) of those patients experienced extraskeletal AEs (most commonly fever and flu-like symptoms [eg, headache, malaise, fatigue, chills, and asthenia]). The percentage of patients reporting AEs was significantly higher for the LFA group than that of the FA group (91.2 vs 19.5; P < 0.001), although factors other than the frequency of treatment might have had a bearing on this finding. All AEs were mild and transient in both groups of patients, and there were no reports of jaw osteonecrosis in either group. It should be noted that although LFA patients received lower doses of pamidronate per infusion than the FA group, they had higher cumulative doses/year. Biochemical variables for the entire study population were compared with baseline measurements, and no significant changes in mean values were observed. Both serum calcium and 25-hydroxy vitamin D levels remained within normal ranges. On the other hand, there was a transient decrease in white blood cell count (WBCC) in 73 (12.0%) patients, and leukopenia was observed in 8 (1.3%) patients. However, 5 of the 6 patients who were leukopenic at the beginning of treatment had normal WBCCs during follow-up. Platelet count decreased significantly in 20 (3.3%) patients, and 5 (0.8%) patients developed thrombocytopenia. Serum creatinine (sCreat) levels increased significantly in 91 (15.0%) patients. This increase was transient and within normal limits (0.6–1.2 mg/dL) in 79 (86.8%) of those patients but persistent in the other 12 (13.2%), all of whom received higher doses of pamidronate or had other risk factors for renal failure such as advanced age, diabetes, multiple myeloma, or an obstructor disease. Baseline sCreat level for 7 of these 12 patients was >1.20 mg/dL.
Conclusions: Pamidronate administered IV was well tolerated when used for treating osteoporosis or other metabolic osteopathies in our study population. The clinical AEs observed with IV pamidronate administration were not serious and hematologic changes were mild, transient, and not associated with dose, time of treatment, or any particular underlying disease. An increase in sCreat level was the most frequent biochemical complication and was found in patients with additional risk factors for renal failure and particular diseases. Whether certain patients with risk factors for osteoporosis may require even fewer IV administrations of the drug is an issue that remains to be elucidated.
PMCID: PMC3965997
adverse events; pamidronate; osteoporosis; osteopathy; tolerability
4.  Methotrexate osteopathy in rheumatic disease. 
Annals of the Rheumatic Diseases  1993;52(8):582-585.
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.
PMCID: PMC1005115  PMID: 8215620
5.  Editorial 
Genome Biology  2002;4(1):101.
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.
PMCID: PMC151276
6.  Editorial 
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.
PMCID: PMC3400394
7.  The effect of health care reform on academic medicine in Canada. Editorial Committee of the Canadian Institute for Academic Medicine. 
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.
PMCID: PMC1487837  PMID: 8624998
8.  Editorial policy and the assessment of quality among medical journals. 
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.
PMCID: PMC227746  PMID: 3450342
9.  Editorial of the Special Issue Antimicrobial Polymers 
The special issue “Antimicrobial Polymers” includes research and review papers concerning the recent advances on preparation of antimicrobial polymers and their relevance to industrial settings and biomedical field. Antimicrobial polymers have recently emerged as promising candidates to fight microbial contamination onto surfaces thanks to their interesting properties. In this special issue, the main strategies pursued for developing antimicrobial polymers, including polymer impregnation with antimicrobial agents or synthesis of polymers bearing antimicrobial moieties, were discussed. The future application of these polymers either in industrial or healthcare settings could result in an extremely positive impact not only at the economic level but also for the improvement of quality of life.
PMCID: PMC3794765  PMID: 24005863
antimicrobial polymers; antifouling polymers; antimicrobial agent delivery systems; cationic polymers; microbial biofilms; titania; silver; magnetic nanoparticles; nanocomposites; chitosan; usnic acid
10.  Lead editorial: Trials – using the opportunities of electronic publishing to improve the reporting of randomised trials 
Trials  2006;7:6.
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.
PMCID: PMC1449870  PMID: 16556322
11.  The long tail: a usage analysis of pre-1993 print biomedical journal literature 
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.
PMCID: PMC2212321  PMID: 18219377
12.  Women on professional society and journal editorial boards. 
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.
PMCID: PMC2574346  PMID: 17668642
13.  Has the impact of heat waves on mortality changed in France since the European heat wave of summer 2003? A study of the 2006 heat wave 
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.
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.
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).
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.
PMCID: PMC2652641  PMID: 18194962
Aged; Female; France; epidemiology; Heat Stress Disorders; prevention & control; Humans; Infrared Rays; adverse effects; Male; Middle Aged; Models, Biological; Models, Statistical; Mortality; trends; Seasons; Temperature; heat waves; mortality; excess mortality; preventive measures
14.  What do the JAMA editors say when they discuss manuscripts that they are considering for publication? Developing a schema for classifying the content of editorial discussion 
In an effort to identify previously unrecognized aspects of editorial decision-making, we explored the words and phrases that one group of editors used during their meetings.
We performed an observational study of discussions at manuscript meetings at JAMA, a major US general medical journal. One of us (KD) attended 12 editorial meetings in 2003 as a visitor and took notes recording phrases from discussion surrounding 102 manuscripts. In addition, editors attending the meetings completed a form for each manuscript considered, listing the reasons they were inclined to proceed to the next step in publication and reasons they were not (DR attended 4/12 meetings). We entered the spoken and written phrases into NVivo 2.0. We then developed a schema for classifying the editors' phrases, using an iterative approach.
Our classification schema has three main themes: science, journalism, and writing. We considered 2,463 phrases, of which 87 related mainly to the manuscript topic and were not classified (total 2,376 classified). Phrases related to science predominated (1,274 or 54%). The editors, most of whom were physicians, also placed major weight on goals important to JAMA's mission (journalism goals) such as importance to medicine, strategic emphasis for the journal, interest to the readership, and results (729 or 31% of phrases). About 16% (n = 373) of the phrases used related to writing issues, such as clarity and responses to the referees' comments.
Classification of editorial discourse provides insight into editorial decision making and concepts that need exploration in future studies.
PMCID: PMC2121101  PMID: 17894854
15.  Improving the utilization of admission order sets in a computerized physician order entry system by integrating modular disease specific order subsets into a general medicine admission order set 
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).
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.
PMCID: PMC3078659  PMID: 21422099
Computerized physician order entry; electronic medical record; standardized order; nested order; usual; CPOE; improving the utilization of admission order sets; machine learning
16.  The journal 'chiropractic & osteopathy' changes its title to 'chiropractic & manual therapies'. a new name, a new era 
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.
PMCID: PMC3039828  PMID: 21247414
17.  Managing back pain in general practice--is osteopathy the new paradigm? 
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.
PMCID: PMC1410127  PMID: 9474832
18.  Osteological and Biomolecular Evidence of a 7000-Year-Old Case of Hypertrophic Pulmonary Osteopathy Secondary to Tuberculosis from Neolithic Hungary 
PLoS ONE  2013;8(10):e78252.
Seventy-one individuals from the late Neolithic population of the 7000-year-old site of Hódmezővásárhely-Gorzsa were examined for their skeletal palaeopathology. This revealed numerous cases of infections and non-specific stress indicators in juveniles and adults, metabolic diseases in juveniles, and evidence of trauma and mechanical changes in adults. Several cases showed potential signs of tuberculosis, particularly the remains of the individual HGO-53. This is an important finding that has significant implications for our understanding of this community. The aim of the present study was to seek biomolecular evidence to confirm this diagnosis. HGO-53 was a young male with a striking case of hypertrophic pulmonary osteopathy (HPO), revealing rib changes and cavitations in the vertebral bodies. The initial macroscopic diagnosis of HPO secondary to tuberculosis was confirmed by analysis of Mycobacterium tuberculosis complex specific cell wall lipid biomarkers and corroborated by ancient DNA (aDNA) analysis. This case is the earliest known classical case of HPO on an adult human skeleton and is one of the oldest palaeopathological and palaeomicrobiological tuberculosis cases to date.
PMCID: PMC3813517  PMID: 24205173
19.  Cranial osteopathy: its fate seems clear 
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.
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.
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.
PMCID: PMC1564028  PMID: 16762070
20.  Osteopathy and resistance to vitamin D toxicity in mice null for vitamin D binding protein 
Journal of Clinical Investigation  1999;103(2):239-251.
A line of mice deficient in vitamin D binding protein (DBP) was generated by targeted mutagenesis to establish a model for analysis of DBP's biological functions in vitamin D metabolism and action. On vitamin D–replete diets, DBP–/– mice had low levels of total serum vitamin D metabolites but were otherwise normal. When maintained on vitamin D–deficient diets for a brief period, the DBP–/–, but not DBP+/+, mice developed secondary hyperparathyroidism and the accompanying bone changes associated with vitamin D deficiency. DBP markedly prolonged the serum half-life of 25(OH)D and less dramatically prolonged the half-life of vitamin D by slowing its hepatic uptake and increasing the efficiency of its conversion to 25(OH)D in the liver. After an overload of vitamin D, DBP–/– mice were unexpectedly less susceptible to hypercalcemia and its toxic effects. Peak steady-state mRNA levels of the vitamin D–dependent calbindin-D9K gene were induced by 1,25(OH)2D more rapidly in the DBP–/– mice. Thus, the role of DBP is to maintain stable serum stores of vitamin D metabolites and modulate the rates of its bioavailability, activation, and end-organ responsiveness. These properties may have evolved to stabilize and maintain serum levels of vitamin D in environments with variable vitamin D availability.
PMCID: PMC407885  PMID: 9916136
21.  Craniomandibular osteopathy in a bullmastiff 
The Canadian Veterinary Journal  2002;43(11):883-885.
A 6-month-old bullmastiff was presented with bilateral painful swellings of the mandible. Craniomandibular osteopathy was diagnosed based on skull radiographs and histological findings from bone biopsies. Treatment consisted of meloxicam to alleviate the pain. Three months later, the dog was pain free without medication or palpable change in the mandible.
PMCID: PMC339767  PMID: 12497967
22.  Editorial Peer Reviewers' Recommendations at a General Medical Journal: Are They Reliable and Do Editors Care? 
PLoS ONE  2010;5(4):e10072.
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).
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.
PMCID: PMC2851650  PMID: 20386704
23.  What is a pilot or feasibility study? A review of current practice and editorial policy 
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.
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.
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'.
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.
PMCID: PMC2912920  PMID: 20637084
24.  Ethical and Practical Guidelines for Reporting Genetic Research Results To Study Participants: Updated Guidelines from an NHLBI Working Group 
In January 2009 the National Heart, Lung, and Blood Institute (NHLBI) convened a 28-member multidisciplinary Working Group to update the recommendations of a 2004 NHLBI Working Group focused on Guidelines to the Return of Genetic Research Results. Changes in the genetic and societal landscape over the intervening five years raise multiple questions and challenges. The group noted the complex issues arising from the fact that the technologic and bioinformatic progress has made it possible to obtain considerable information on individuals which would not have been possible a decade ago. While unable to reach consensus on a number of issues, the Working Group produced five recommendations. The Working Group offers two recommendations addressing the criteria necessary to determine when genetic results should and may be returned to study participants, respectively. In addition, it suggests that a time limit be established to limit the duration of obligation of investigators to return genetic research results. The Group recommends the creation of a central body, or bodies, to provide guidance on when genetic research results are associated with sufficient risk and have established clinical utility to justify their return to study participants. The final Recommendation urges investigators to engage the broader community when dealing with identifiable communities to advise them on the return of aggregate and individual research results. Creation of an entity charged to provide guidance to IRBs, investigators, research institutions and research sponsors would provide rigorous review of available data, promote standardization of study policies regarding return of genetic research results, and enable investigators and study participants to clarify and share expectations for the handling of this increasingly valuable information with appropriate respect for the rights and needs of participants.
PMCID: PMC3090664  PMID: 21156933
consent genetics; ethics; research genetics; risk rediction; single nucleotide polymorphism genetics
25.  The association between weight loss and engagement with a web-based food and exercise diary in a commercial weight loss programme: a retrospective analysis 
The Internet provides a widely accessible platform for weight loss interventions. Automated tools can allow self-guided monitoring of food intake and other target behaviours that are established correlates of weight change. Many programmes also offer social support from the virtual community. The aim of this research was to assess associations between engagement with self-monitoring tools and social support, and weight loss in an online weight-control programme.
This paper describes a retrospective analysis of weight change among 3621 subscribers to a commercial Internet-based weight loss programme. Participants were all subscribers (2979 women; 642 men) joining the programme between July 2005 and November 2008 with two or more recorded weights spanning at least 28 days of participation in the programme. Engagement was indexed with frequency of using online diet and exercise diaries and with use of the social support forums.
Programme engagement was associated with weight loss in both men and women after controlling for initial BMI and duration of participation. The three engagement variables accounted for 13% of variance in percentage weight loss in women (p < .001) and 19% in men (p < .001). In analyses including all the engagement variables, exercise diary use was an independent predictor of weight loss among men, but non-significant in women. In contrast, use of the online forums was associated with weight loss in women but not in men. Among participants who were overweight or obese, those in the highest tertile of engagement with food diaries (vs the lowest) were more likely to achieve clinically significant (> 5%) weight loss (men: OR = 3.45 p < .001; women: OR = 5.05 p < .001). Being in the highest tertile of engagement with exercise diaries was associated with clinically significant weight loss in men (OR = 3.48 p < .001) and, less strongly, in women (OR = 1.46 p < .05).
Use of self-monitoring tools and participation in online support are predictive of weight loss in the context of a commercial, online weight control programme.
PMCID: PMC3162876  PMID: 21810222

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