Prevalence, burden, and clinical management of migraine in China, Japan, and South Korea: a comprehensive review of the literature.

BACKGROUND: The objective of this review was to determine the unmet needs for migraine in East Asian adults and children. METHODS: We searched MEDLINE and EMBASE (January 1, 1988 to January 14, 2019). Studies reporting the prevalence, humanistic and economic burden, and clinical management of migraine in China (including Hong Kong and Taiwan), Japan, and South Korea were included. Studies conducted before 1988 (before the International Headache Society [IHS] first edition of the International Classification of Headache Disorders) were not included. RESULTS: We retrieved 1337 publications and 41 met the inclusion criteria (28 from China, 7 from Japan, and 6 from South Korea). The 1-year prevalence of migraine (IHS criteria) among adults ranged from 6.0% to 14.3%. Peak prevalence ranged from 11% to 20% for women and 3% to 8% for men (30- to 49-year-olds). For children, prevalence of migraine increased with age. Information on the economic burden and clinical management of migraine was limited, particularly for children. When reported, migraine was significantly associated with high levels of disability and negative effects on quality of life. Studies suggested low levels of disease awareness/diagnosis within each country. Of individuals with migraine from China, 52.9% to 68.6% had consulted a physician previously, 37.2% to 52.7% diagnosed with headache had not been diagnosed with migraine previously, and 13.5% to 18% had been diagnosed with migraine previously. Of individuals with migraine from Japan, 59.4% to 71.8% had never consulted a physician previously, 1.3% to 7.3% regularly consulted physicians for their headache, and only 11.6% of individuals with migraine were aware that they had migraine. In addition, studies suggested that over-the-counter medication use was high and prescription medication use was low in each country. CONCLUSIONS: This review suggests that there are unmet needs for migraine in terms of sufficient and appropriate diagnosis, and better management and therapies for treatment of migraine in East Asia. The findings are limited by a lack of recent information and significant gaps in the literature. More recent, population-based studies assessing disease burden and clinical management of migraine are needed to confirm unmet needs for migraine across East Asia.

High nonpublication rate from publication professionals hinders evidence-based publication practices.

Background. The need for timely, ethical, and high-quality reporting of clinical trial results has seen a rise in demand for publication professionals. These publication experts, who are not ghostwriters, work with leading medical researchers and funders around the world to plan and prepare thousands of publications each year. Despite the involvement of publication professionals in an increasing number of peer-reviewed publications, especially those that affect patient care, there is limited evidence-based guidance in the peer-reviewed literature on their publication practices. Similar to the push for editors and the peer-review community to conduct and publish research on publication ethics and the peer-review process, the International Society for Medical Publication Professionals (ISMPP) has encouraged members to conduct and publish research on publication planning and practices. Our primary objective was to investigate the publication rate of research presented at ISMPP Annual Meetings. Methods. ISMPP Annual Meeting abstract lists (April 2009-April 2014) were searched in November 2014 and data were extracted into a pilot-tested spreadsheet. MEDLINE was searched in December 2014 to determine the publication rate (calculated as the % of presented abstracts published as full papers in peer-reviewed journals). Data were analyzed using the Cochran-Armitage trend test (significance: P < .05) by an independent academic statistician. Results. From 2009 to 2014, there were 220 abstracts submitted, 185 accepted, and 164 presented. There were four corresponding publications (publication rate 2.4%). Over time, ISMPP's abstract acceptance rate (overall: 84.1%) did not change, but the number of abstracts presented increased significantly (P = .02). Most abstracts were presented as posters (81.1%) and most research was observational (72.6%). Most researchers came from the US (78.0%), followed by Europe (17.7%), and the Asia-Pacific region (11.2%). Discussion. Research presented at ISMPP Annual Meetings has rarely been published in peer-reviewed journals. The high rate of nonpublication by publication professionals has now been quantified and is of concern. Publication professionals should do more to contribute to evidence-based publication practices, including, and especially, their own. Unless the barriers to publication are identified and addressed, the practices of publication professionals, which affect thousands of peer-reviewed publications each year, will remain hidden and unproven.

Sponsor-Imposed Publication Restrictions Disclosed on ClinicalTrials.gov.

We investigated whether sponsor-imposed publication restrictions for ClinicalTrials.gov trials were reasonable, based on consistency with Good Publication Practice 2 (GPP2). ClinicalTrials.gov trial record data were electronically imported (October 7, 2012) and screened for eligibility (phase 2-4, interventional, recruitment closed, results available, first received for registration after November 10, 2009, any sponsor type, investigators not sponsor employees). Two authors categorized restrictions information as consistent or not consistent with GPP2, resolving discrepancies by consensus. Of the eligible trials (388/484, n = 81,768 participants), 80.7% (313/388) had restrictions disclosed, and 92.5% (311/388) were industry-sponsored. Significantly more trials had restrictions that were consistent with GPP2 than not (74.1% [232/313], n = 55,280 participants vs. 25.9% [81/313], n = 19,677 participants; P < .001). Reasons for inconsistency were insufficient, unclear, or ambiguous information (48.1%, 39/81), sponsor-required approval for publication (35.8%, 29/81), sponsor-required text changes (8.6%, 7/81), and outright bans (7.4%, 6/81). Follow-up of trials with insufficient information and a contact email (response rate, 46.9% [15/32]) revealed 2 additional bans. A total of 776 participants had consented to trials that had publication bans. Many, but not all, sponsor-imposed publication restrictions disclosed on ClinicalTrials.gov may be considered reasonable. Sponsors should ensure restrictions are appropriately disclosed. Volunteers should be alerted to any restrictions before consenting to participate in a clinical trial.

Systematic review on the primary and secondary reporting of the prevalence of ghostwriting in the medical literature.

BACKGROUND: Ghostwriting of industry-sponsored articles is unethical and is perceived to be common practice. OBJECTIVE: To systematically review how evidence for the prevalence of ghostwriting is reported in the medical literature. DATA SOURCES: MEDLINE via PubMed 1966+, EMBASE 1966+, The Cochrane Library 1988+, Medical Writing 1998+, The American Medical Writers Association (AMWA) Journal 1986+, Council of Science Editors Annual Meetings 2007+, and the Peer Review Congress 1994+ were searched electronically (23 May 2013) using the search terms ghostwrit*, ghostauthor*, ghost AND writ*, ghost AND author*. ELIGIBILITY CRITERIA: All publication types were considered; only publications reporting a numerical estimate of possible ghostwriting prevalence were included. DATA EXTRACTION: Two independent reviewers screened the publications; discrepancies were resolved by consensus. Data to be collected included a numerical estimate of the prevalence of possible ghostwriting (primary outcome measure), definitions of ghostwriting reported, source of the reported prevalence, publication type and year, study design and sample population. RESULTS: Of the 848 publications retrieved and screened for eligibility, 48 reported numerical estimates for the prevalence of possible ghostwriting. Sixteen primary publications reported findings from cross-sectional surveys or descriptive analyses of published articles; 32 secondary publications cited published or unpublished evidence. Estimates on the prevalence of possible ghostwriting in primary and secondary publications varied markedly. Primary estimates were not suitable for meta-analysis because of the various definitions of ghostwriting used, study designs and types of populations or samples. Secondary estimates were not always reported or cited correctly or appropriately. CONCLUSIONS: Evidence for the prevalence of ghostwriting in the medical literature is limited and can be outdated, misleading or mistaken. Researchers should not inflate estimates using non-standard definitions of ghostwriting nor conflate ghostwriting with other unethical authorship practices. Editors and peer reviewers should not accept articles that incorrectly cite or interpret primary publications that report the prevalence of ghostwriting.

Publication misconduct and plagiarism retractions: a systematic, retrospective study.

OBJECTIVES: To investigate whether plagiarism is more prevalent in publications retracted from the medical literature when first authors are affiliated with lower-income countries versus higher-income countries. Secondary objectives included investigating other factors associated with plagiarism (e.g., national language of the first author's country affiliation, publication type, journal ranking). DESIGN: Systematic, controlled, retrospective, bibliometric study. DATA SOURCE: Retracted publications dataset in MEDLINE (search filters: English, human, January 1966-February 2008). DATA SELECTION: Retracted misconduct publications were classified according to the first author's country affiliation, country income level, and country national language, publication type, and ranking of the publishing journal. Standardised definitions and data collection tools were used; data were analysed (odds ratio [OR], 95% confidence limits [CL], chi-squared tests) by an independent academic statistician. RESULTS: Of the 213 retracted misconduct publications, 41.8% (89/213) were retracted for plagiarism, 52.1% (111/213) for falsification/fabrication, 2.3% (5/213) for author disputes, 2.3% (5/213) for ethical issues, and 1.4% (3/213) for unknown reasons. The OR (95% CL) of plagiarism retractions (other misconduct retractions as reference) were higher (P < 0.001) for first authors affiliated with lower-income versus higher-income countries (15.4 [4.5, 52.9]) and with non-English versus English national language countries (3.2 [1.8, 5.7]), for non-original research versus original research publications (8.4 [3.3, 21.3]), for case reports and series versus other original research types (4.2 [1.4, 13.0]), and for publications in low-ranked versus high-ranked journals (4.9 [2.4, 9.9]). Up until 2012, there were significantly (P < 0.007) fewer 'serial offenders' (first authors with >1 retraction) with publications retracted for plagiarism (11.5%, 9/78) than other types of misconduct (28.9%, 24/83). CONCLUSIONS: This is the first study to demonstrate that publications retracted for plagiarism are significantly associated with first authors affiliated with lower-income countries. These findings have implications for developing appropriate evidence-based strategies and allocation of resources to help mitigate plagiarism misconduct.

Lack of involvement of medical writers and the pharmaceutical industry in publications retracted for misconduct: a systematic, controlled, retrospective study.

OBJECTIVES: The primary objective of this study was to quantify how many publications retracted because of misconduct involved declared medical writers (i.e., not ghostwriters) or declared pharmaceutical industry support. The secondary objective was to investigate factors associated with misconduct retractions. DESIGN: A systematic, controlled, retrospective, bibliometric study. DATA SOURCE: Retracted publications dataset in the MEDLINE database. DATA SELECTION: PubMed was searched (Limits: English, human, January 1966 - February 2008) to identify publications retracted because of misconduct. Publications retracted because of mistake served as the control group. Standardized definitions and data collection tools were used, and data were analyzed by an independent academic statistician. RESULTS: Of the 463 retracted publications retrieved, 213 (46%) were retracted because of misconduct. Publications retracted because of misconduct rarely involved declared medical writers (3/213; 1.4%) or declared pharmaceutical industry support (8/213; 3.8%); no misconduct retractions involved both declared medical writers and the industry. Retraction because of misconduct, rather than mistake, was significantly associated with: absence of declared medical writers (odds ratio: 0.16; 95% confidence interval: 0.05-0.57); absence of declared industry involvement (0.25; 0.11-0.58); single authorship (2.04; 1.01-4.12); first author having at least one other retraction (2.05; 1.35-3.11); and first author affiliated with a low/middle income country (2.34; 1.18-4.63). The main limitations of this study were restricting the search to English-language and human research articles. CONCLUSIONS: Publications retracted because of misconduct rarely involved declared medical writers or declared pharmaceutical industry support. Increased attention should focus on factors that are associated with misconduct retractions.

Solution toxicity in soft contact lens daily wear is associated with corneal inflammation.

PURPOSE: Contact lens-associated solution toxicity manifests as generalized, mild punctate epithelial fluorescein staining and usually is widely reported as asymptomatic, with no substantial clinical sequelae. This study examined the relationship between solution toxicity and corneal infiltrative events (CIEs) in soft contact lens daily wear. METHODS: Several nonrandomized interventional clinical trials conducted between May and November 2005 were analyzed retrospectively. Subjects wore commercially available soft contact lenses bilaterally, on a daily schedule, disinfected overnight using marketed lens care solutions for 3 months with monthly disposal. Solution toxicity was defined as diffuse punctate staining in at least four of five areas of the cornea after instillation of sodium fluorescein. First events of corneal staining or corneal infiltrates were used to calculate incidence (per 100 eye months). RESULTS: Toxic staining was detected in 77 of 609 subjects and all CIEs were mild and symptomatic or asymptomatic. The incidence of CIEs in eyes with a predisposition to toxic staining was 6.7% and in unaffected eyes was 2.3%. CIEs were 3-times more likely to occur in eyes that exhibited solution toxicity compared to unaffected eyes (odds ratio = 3.08, p = 0.008, 95% CI 1.40 to 6.76). Previous events of limbal redness (> or =grade 2.0) were not associated with CIEs (odds ratio = 1.53, p = 0.364, 95% CI 0.63 to 3.70). The rate of CIEs increased as the rate of toxic staining increased for specific lens type-solution combinations (Spearman's rho = 0.558, p = 0.025, n = 16), and peroxide-based solutions consistently resulted in the lowest rates of toxic staining and corneal inflammation. CONCLUSIONS: Eyes that experience solution toxicity are more likely to experience a CIE. Daily wear soft lens wearers should be routinely examined with sodium fluorescein soon after lenses are inserted and alternative solution/lens type combinations should be investigated if toxic staining is detected.

Silicone hydrogel contact lenses and the ocular surface.

For 30 years, contact lens research focused on the need for highly oxygen-permeable (Dk) soft lens materials. High Dk silicone hydrogel contact lenses, made available in 1999, met this need. The purpose of this review is to examine how silicone hydrogel lens wear affects the ocular surfaces and to highlight areas in which further research is needed to improve biocompatibility. Silicone hydrogel lenses have eliminated lens-induced hypoxia for the majority of wearers and have a less pronounced effect on corneal homeostasis compared to other lens types; however, mechanical interaction with ocular tissue and the effects on tear film structure and physiology are similar to that found with soft lens wear in general. Although the ocular health benefits of silicone hydrogel lenses have increased the length of time lenses can be worn overnight, the risk of infection is similar to that found with other soft lens types, and overnight wear remains a higher risk factor for infection than daily wear, regardless of lens material. Future contact lens research will focus on gaining a better understanding of the way in which contact lenses interact with the corneal surface, upper eyelid, and the tear film, and the lens-related factors contributing to infection and inflammatory responses.

Microbial keratitis in prospective studies of extended wear with disposable hydrogel contact lenses.

PURPOSE: To report the annualized incidence of microbial keratitis with extended wear of low oxygen transmissible (Dk/t) disposable soft contact lenses from prospective postmarket clinical trials. METHODS: Seven hundred ninety subjects were enrolled at the L.V. Prasad Eye Institute (LVPEI), Hyderabad, India from March 1993 to March 2000, resulting in 1231 patient eye years, and 167 subjects were enrolled at the Cornea and the Contact Lens Research Unit (CCLRU), Sydney, Australia from July 1987 to December 1999, resulting in 842 patient eye years. RESULTS: The annualized incidence of microbial keratitis per 10,000 eyes per year of lens wear was 32.5 (95% CI 8.9 to 83.2) for LVPEI, 23.8 (95% CI=2.9 to 85.8) for CCLRU; when data are combined across both centers, the incidence was 28.9 (95% CI=10.6 to 63) per 10,000 eyes per year of lens wear. This equates to 57.0 per 10,000 wearers or 1 in 173 wearers per year of lens wear. All events were rated as slight to moderate in severity and did not result in visual loss. Two events were described to highlight the challenges in diagnosis and treatment of microbial keratitis. CONCLUSIONS: The incidence of microbial keratitis with extended wear of low-Dk/t disposable lenses was higher in these prospective studies (1 in 210 wearers per year at CCLRU and 1 in 154 wearers per year at LVPEI) than that seen in retrospective population-based surveillance studies (1 in 500 wearers per year). Practitioners and patients should always be alert to signs and symptoms, and practitioners should adopt conservative strategies for diagnosis and management of contact lens-related adverse events.

Changes in myopia with low-Dk hydrogel and high-Dk silicone hydrogel extended wear.

PURPOSE: This study compared changes in myopia between wearers of high-oxygen permeability (Dk) silicone hydrogel lenses and low-Dk hydrogel lenses after 1 year of extended wear (EW). METHODS: Ninety-two adult subjects were randomly assigned to a lens type. Subjective refraction and autokeratometry were performed at baseline and at 6 and 12 months. RESULTS: After 6 months of EW, myopia (spherical equivalent) regressed by 0.18 +/- 0.33 D (p < 0.001) in the high-Dk silicone hydrogel group and progressed by -0.23 +/- 0.36 D (p < 0.001) in the low-Dk hydrogel group. There were no further changes after 12 months. Previous lens wear history, baseline refractive error, and age and gender did not have an impact on the change in myopia, and only 35% of the variation could be accounted for by changes in corneal curvature and lens type. CONCLUSION: Soft contact lens type significantly affects the direction of change in myopia during EW. We hypothesize that these changes are driven by pressure-related redistribution of corneal tissue in high-Dk silicone hydrogel lens wearers and by hypoxia-associated corneal thinning in low-Dk hydrogel wearers. More long-term studies are required to confirm whether the effects of high-Dk silicone hydrogel lens wear on myopia are permanent.

Comparison of the performance of 6- or 30-night extended wear schedules with silicone hydrogel lenses over 3 years.

AIM: To compare the clinical performance of silicone hydrogel lenses worn for 6- or 30-nights, with monthly replacement, for 3 years. METHODS: In this 3-year prospective clinical trial, 161 subjects were enrolled and 154 commenced extended wear. Clinical performance was assessed by comparing discontinuations and lens surface characteristics (front surface deposits, lens wettability, number of mucin balls), lens fitting performance (primary gaze movement, lens tightness), and physiologic parameters (limbal and bulbar redness, corneal and conjunctival staining, microcysts) and subjective parameters (ratings of comfort and vision) between groups. RESULTS: Eighty-eight subjects remained in the study after 36 months. There were no differences in the probability of subjects surviving in either group, and the major cause of lens-related discontinuation in both groups was contact lens-induced papillary conjunctivitis. There were no clinically important differences in performance between wear schedules. CONCLUSION: The long-term clinical performance of silicone hydrogels worn for 6- or 30-nights continuously was similar. Clinical markers of hypoxia were low in both groups, and the 6-night wear schedule was not superior to the 30-night wear schedule with regard to preventing lens spoilage, improving corneal physiology, or subjective symptoms of comfort and vision.

Corneal hypoxia secondary to contact lenses: the effect of high-Dk lenses.

Contact lenses made from materials of low-oxygen permeability (Dk) do not meet the oxygen requirements of the cornea for overnight wear. Long-term extended wear of these lenses results in chronic changes to all layers of the cornea, many of which are associated with hypoxia. High-Dk silicone hydrogel and gas permeable lenses are now available for 30-night continuous wear. The high-oxygen transmissibilities of these lenses have enabled the development of a successful continuous wear modality by eliminating the hypoxic effects of long-term wear. Presently, the focus is on improving lens performance by developing lenses that are more biocompatible, provide greater comfort, and maintain a stable tear film without inflammatory or mechanically induced adverse events.

Microbial keratitis and vision loss with contact lenses.

PURPOSE: Microbial keratitis is the only sight-threatening adverse event that occurs with contact lens wear. This article gives a preliminary estimation of the incidence of microbial keratitis and vision loss with continuous-wear contact lenses made from highly oxygen permeable (Dk) materials. METHODS: The most up-to-date data available on microbial keratitis and vision loss are collected from a range of sources including industry, private practice, and publications and is reviewed. RESULTS: There have been 16 cases of microbial keratitis with high-Dk silicone hydrogel lenses. Of the 13 where data are available, none have lost two or more lines of best-corrected visual acuity (BCVA). CONCLUSION: First approximation indicates that the incidence of microbial keratitis with high-Dk silicone hydrogel lenses may be lower than the incidence with low-Dk soft lenses during extended wear. The rate of loss of more than two lines of BCVA is low in patients that develop microbial keratitis with low- and high-Dk soft lenses.

Hypersensitivity responses and contact lens wear.

Hypersensitivity diseases that involve the eye are common reasons why patients present to eyecare practitioners. Common ocular hypersensitivity disorders include allergic conjunctivitis, giant or contact lens induced papillary conjunctivitis and atopic keratoconjunctivitis. The diagnosis and management of ocular hypersensitivity can present a challenge to eyecare practitioners and an understanding of the mechanisms that underlie the signs and symptoms of such conditions is necessary for their appropriate management. This article reviews the mechanisms by which the eye responds to antigenic challenges, the pathogenesis of ocular hypersensitivity responses, particularly in relation to contact lens wear, and illustrates possible management strategies.

Corneal ulceration in pediatric patients: a brief overview of progress in topical treatment.

Pediatric microbial keratitis is a rare but potentially devastating condition. The condition is similar to adult microbial keratitis, but is often characterized by a more severe inflammatory response. The micro-organisms that cause microbial keratitis in children are similar to the causative agents in adults, with herpes simplex and bacteria being the predominant causative agents, and fungi being less frequent. Of the bacterial pathogens, Pseudomonas aeruginosa, Staphylococcus aureus and alpha-hemolytic streptococci are common. The risk factors for pediatric keratitis include colonization of the eyes during birth and trauma to the cornea. Certain microbial factors involved in microbial keratitis are common to all micro-organisms, including adhesion to the cornea, penetration into the cornea, destruction of the corneal stroma (usually by microbial and/or host proteases), and recruitment of white blood cells to help defend the eye. Specific inflammatory responses that occur during pediatric microbial keratitis are not known in detail, but it is likely that cytokines and polymorphonuclear leucocytes are major factors, as they are in adult microbial keratitis. Treatment for pediatric microbial keratitis is usually the same as treatment for adult microbial keratitis; topical application of antimicrobial agents initially, followed by application of anti-inflammatory agents. With pediatric microbial keratitis, extra care must be taken to ensure nontoxicity due to blood adsorption. New microbial keratitis treatments are being developed and these mainly focus on new antimicrobials, antivirulence agents (such as vaccination against microbial toxins) or specific anti-inflammatory agents. There remains a clear need for increased research into the specific responses during microbial keratitis in children which will help progress new therapies as well as the development of new antimicrobials, especially new antifungal therapies.