This paper assessed 300 surfboard riders, comprising 229 males and 71 females to determine the prevalence and rate of growth of exostoses in this population. A group of cold water swimmers and a control group were also examined. Significant obstruction, defined as two thirds or more occlusion of the ear canal was noted in 90 of the male surfers and 10 female surfers. This degree of occlusion was found in seven of the 32 cold water swimmers. A male surfer who has surfed regularly for 20 years or more has a one in two chance of developing significant obstruction of the external ear canal resulting from exostoses and this is a three in seven chance for females.

No abstract

Twenty-two cases of perforated tympanic membrane due to fungal otitis externa were observed over a five-year period. The diagnosis of fungal otitis externa was made on clinical grounds due to the obvious presence of fungal bloom in the external ear canal. Some perforations were noted at the first treatment after the fungal debris had been removed from the external ear canal using a microscope. Other perforations were observed to develop over a few days. Initially, a discrete area of the tympanic membrane appeared white and opaque. As time progressed the white area disintegrated, forming a perforation. Once the otitis externa had resolved most perforations healed spontaneously. Two that were observed to develop during treatment required a myringoplasty. Another one closed significantly but a tiny persistent perforation required cauterization with trichloracetic acid to encourage it to close over completely. The only residual hearing loss was in a case with almost total disintegration of the tympanic membrane requiring a myringoplasty. Treatment of fungal otitis externa for the patients in this series was aural toilet using suction under a microscope and insertion of a gauze wick saturated in a combination of hydrocortisone, clotrimazole, framycetin and gramicidin.

A favorable benefit–risk profile remains an essential requirement for marketing authorization of medicinal drugs and devices. Furthermore, prior subjective, implicit and inconsistent ad hoc benefit–risk assessment methods have rightly evolved towards more systematic, explicit or “structured” approaches. Contemporary structured benefit–risk evaluation aims at providing an objective assessment of the benefit–risk profile of medicinal products and a higher transparency for decision making purposes. The use of a descriptive framework should be the preferred starting point for a structured benefit–risk assessment. In support of more precise assessments, quantitative and semi-quantitative methodologies have been developed and utilized to complement descriptive or qualitative frameworks in order to facilitate the structured evaluation of the benefit–risk profile of medicinal products. In addition, quantitative structured benefit–risk analysis allows integration of patient preference data. Collecting patient perspectives throughout the medical product development process has become increasingly important and key to the regulatory decision-making process. Both industry and regulatory authorities increasingly rely on descriptive structured benefit–risk evaluation and frameworks in drug, vaccine and device evaluation and comparison. Although varied qualitative methods are more commonplace, quantitative approaches have recently been emphasized. However, it is unclear how frequently these quantitative frameworks have been used by pharmaceutical companies to support submission dossiers for drug approvals or to respond to the health authorities’ requests. The objective of this study has been to identify and review, for the first time, currently available, published, structured, quantitative benefit–risk evaluations which may have informed health care professionals and/or payor as well as contributed to decision making purposes in the regulatory setting for drug, vaccine and/or device approval. Plain language summary Quantitative evaluation of the benefit–risk balance for medicinal products The review of the benefits and the risks associated with a medicinal product is called benefit–risk assessment. One of the conditions for a medicinal product to receive marketing authorization is to demonstrate a positive benefit–risk balance in which the benefits outweigh the risks. In order to enhance the transparency and consistency in the assessment of benefit–risk balance, frameworks and quantitative methods have been developed for decision making purposes and regulatory approvals of medicinal products. This article considers published quantitative benefit–risk evaluations which may have informed health care professionals and/or payor as well as contributed to decision making purposes in the regulatory setting for drug, vaccine and/or device approval.

No abstract