The Physician's Duty to Warn Their Patients About the Risks Associated with Medical Intervention: A Review and Discussion.

Since the landmark case of Montgomery v Lanarkshire in 20151, much has been written in medical press regarding the implications for medical practice. The moral duty - varied though it has been over this time, has been discussed since the earliest days of the medical profession. The law has sought to define this duty in response to changes in society, and the nature of the relationship between doctor and patient. The moral and legal duty are intrinsically linked, but the latter must surely follow the former for "the law has little to do with morally required forms of communication in the clinic and in the research environment."2 The common law nature of this process has resulted in an inconsistent and often tortuous path as societal standards have shifted. Accordingly, the ultimate definition of the legal doctrine, "informed consent," has changed since its relatively recent entry into the medicolegal vocabulary. These parallel shifts in the legal and moral duty to disclose risk have resulted in a confusing melee of evidence and recommendations for clinicians. We address the development of the law of "informed consent," as the legal mirror of the moral duty upon a clinician to disclose risk to their patient.

Auditory sensory memory and working memory processes in children with normal hearing and cochlear implants.

There can be wide variation in the level of oral/aural language ability that prelingually hearing-impaired children develop after cochlear implantation. Automatic perceptual processing mechanisms have come under increasing scrutiny in attempts to explain this variation. Using mismatch negativity methods, this study explored associations between auditory sensory memory mechanisms and verbal working memory function in children with cochlear implants and a group of hearing controls of similar age. Whilst clear relationships were observed in the hearing children between mismatch activation and working memory measures, this association appeared to be disrupted in the implant children. These findings would fit with the proposal that early auditory deprivation and a degraded auditory signal can cause changes in the processes underpinning the development of oral/aural language skills in prelingually hearing-impaired children with cochlear implants and thus alter their developmental trajectory.

Bipolar scissors versus cold dissection tonsillectomy: a prospective, randomized, multi-unit study.

OBJECTIVE: To evaluate bipolar scissors tonsillectomy by comparing it with traditional cold dissection tonsillectomy. STUDY DESIGN: A prospective, randomized, multi-unit study. SETTINGS: Belfast City Hospital, Royal Victoria Hospital Belfast, and Ulster Hospital Dundonald. PATIENTS: Two hundred consecutive patients undergoing tonsillectomy for recurrent or chronic tonsillitis between March 2000 and September 2000. OUTCOME MEASURES: (1) Intraoperative bleeding, (2) operative time, (3) postoperative pain, and (4) complication rates, including primary and secondary hemorrhage. RESULTS: Seventeen patients were excluded from the study for various reasons. The mean age of the study population was 22 years (range, 10-54 y). Seventy-two percent of patients were female. Twenty-seven percent of patients were children aged 16 years or under. Median intraoperative blood loss was 5 mL for bipolar scissors tonsillectomy and 115 mL for cold dissection tonsillectomy (P < .001). The mean operative time was 13 minutes for bipolar scissors tonsillectomy compared with 20 minutes for the cold dissection method (P < .001). There was no statistically significant difference in the pain scores between the two methods (independent samples t = 1.35; P > .05). The overall primary hemorrhage rate was 2.1%, whereas the overall secondary hemorrhage rate was 16.9%. The hospital readmission rate was 10.3%. The primary and secondary hemorrhage rates were unaffected by the surgical method. CONCLUSIONS: Bipolar scissors tonsillectomy is a safe technique with a similar morbidity to the cold dissection method. Its use is associated with a significant decrease in both surgical time and blood loss compared with the cold dissection method.

A review of cochlear implantation in mitochondrial sensorineural hearing loss.

OBJECTIVE: Mitochondrial sensorineural hearing loss (SNHL) may be nonsyndromic (occurring in isolation), associated with the A1555G mutation in the MTRNR1 gene. Mitochondrial SNHL may also be syndromic, associated with the A3243G point mutation in the MTTL1 gene. In syndromic cases-mitochondrial encephalopathy, lactic acidosis, and strokelike episodes (MELAS), maternally inherited diabetes and deafness, Kearns-Sayre syndrome, and chronic progressive external ophthalmoplegia-the SNHL compounds already existing disabilities. The genetic basis for mitochondrial SNHL and postulated sites of pathologic changes are discussed. DATA SOURCES: Sources used were relevant clinical and basic science publications. STUDY SELECTION: A search of the entire databases of Medline and Web of Science, using various subject headings and free-text terms, was used to identify patients with mitochondrial disease having cochlear implants. DATA EXTRACTION: The data from publications were critically reviewed and tabulated to assess implantation outcomes. DATA SYNTHESIS: The data were not amenable to formal meta-analysis or valid data summarization, other than descriptive statistics. CONCLUSIONS: There is an increasing awareness of the prevalence of mitochondrial SNHL and its progressive nature. High-risk candidates warrant genetic testing and family screening. Correlating the data for mitochondrial SNHL as a treatable entity is important, and the authors present an overview of these patients successfully rehabilitated by cochlear implantation.

Tinnitus suppression by cochlear implants.

The beneficial effects of cochlear implants on tinnitus have been noted in several studies, but few detailed appraisals of the phenomenon have been made. Six patients fitted with the UCSF/Storz cochlear implant device were studied. The effects of use of the implant device on tinnitus were monitored, and suppression of tinnitus was tracked throughout periods of stimulation and poststimulation. Tinnitus was effectively suppressed in five of six patients with the device on and with noise input, and reduction of perceived tinnitus loudness occurred in four of six with the device on but without acoustic input to the speech processor. Unilateral stimulation frequently resulted in bilateral tinnitus suppression. These studies reveal that profound tinnitus suppression is obtained by patients using their cochlear implants. Further work is required to quantify the optimal mode of stimulation, but these findings suggest that tinnitus sufferers may ultimately benefit from development of electrical stimulation tinnitus suppression devices.

Bipolar scissors versus cold dissection for pediatric tonsillectomy--a prospective, randomized pilot study.

OBJECTIVE: To evaluate bipolar scissors tonsillectomy by comparing it with traditional cold dissection tonsillectomy. The outcome measures used were: (1) intra-operative bleeding; (2) operative time; (3) post-operative pain; and (4) complication rates including reactionary and secondary hemorrhage. METHOD: A prospective, randomized multiunit study involving three teaching hospitals in Belfast. Fifty consecutive children aged 10-16 years undergoing tonsillectomy for recurrent or chronic tonsillitis, between March 2000 and September 2000 were recruited as a subgroup of 200 patients selected for this study. These children were analysed separately from the adults, in a pilot study for the above parameters. RESULTS: The mean age of the study population was 14.3 years. Sixty-eight percent of the children were girls. Median intra-operative blood loss was 6 ml for bipolar scissors tonsillectomy and 86 ml for cold dissection tonsillectomy (P<0.001). The median operative time was 10.5 min for bipolar scissors tonsillectomy compared to 14.5 min for the cold dissection method (P=0.001). There was no statistically significant difference in the pain scores between the two methods (P>0.05). The overall reactionary hemorrhage rate was 4% while the overall secondary hemorrhage rate was 14%. The hospital readmission rate was 4%. The reactionary and secondary hemorrhage rates were unaffected by the surgical method. CONCLUSIONS: This pilot study has shown that bipolar scissors tonsillectomy is a relatively safe technique in children aged 10-16 years with a similar morbidity to the cold dissection method. Its use is associated with a significant decrease in surgical time and blood loss compared to the cold dissection method. These advantages make it a favourable instrument for pediatric tonsillectomy especially in this age group.

Comparison of methods of evaluating hearing benefit of middle ear surgery.

The objective of this paper is to compare two methods of predicting the level of subjective patient benefit following reconstructive middle ear surgery. This should have always been an important consideration in advising patients regarding surgery, but assumes even more relevance in these days of clinical audit and cost benefit analysis. The two methods studied were the '15/30 dB rule of thumb' (Smyth and Patterson, 1985) and the 'Glasgow plot' (Browning et al., 1991). The predictions of benefit for each of the two methods were compared to the assessment of actual benefits by the patient post-operatively. The results of this comparison in 153 patients were analysed, the rule of thumb was found to be somewhat more sensitive in predicting patient benefit.

Pneumatic otoscopy: study of inter-observer variability.

The degree of inter-observer variability in the results of pneumatic otoscopy, used to predict the presence or absence of middle ear effusion was assessed. A group of 114 patients with 209 suitable ears had pneumatic otoscopy using a Seigle's speculum performed independently by two observers. The results were compared to the findings at myringotomy, on the basis that mobility of the tympanic membrane was indicative of a dry middle ear. The observers agreed in 187 ears, a concordance rate of 91 per cent, and in 174 of these (93 per cent) the observers' prediction of middle ear state was correct. The overall predictive accuracy of observer A was 89 per cent and of observer B 84 per cent, this difference is not statistically significant, p greater than 0.05.

Comparison of electro and chemical cautery in the treatment of anterior epistaxis.

In the ENT Department of the Royal Victoria Hospital, Belfast, the impression (supported only by anecdotes) was that electro-cautery was superior to chemical cautery in the treatment of simple anterior epistaxis. Since no evaluation of the relative merits of electro and chemical cautery has been reported, a prospective randomized study was conducted to assess the effectiveness of electro-cautery and cautery with silver nitrate. The results of the study showed that there was no statistically significant difference between the two methods in either controlling the epistaxis or in the incidence of complications. It is concluded that since cautery with a silver nitrate tipped applicator is simpler, and of equal effectiveness, it would appear to be the treatment of choice for simple anterior epistaxis.

Cochlear implant extrusion in a child with keratitis, ichthyosis and deafness syndrome.

We present a child with keratitis, ichthyosis and deafness (KID) syndrome implanted with a Nucleus device. We discuss the would complications of this child and the steps taken to deal with the problems encountered when the wound failed to heal, followed by the partial extrusion of her implant. Early surgical management involved resuturing the wound but when this failed a rotational flap was required to cover the implant package and allow eventual healing. Despite the wound problems and revision surgery she has a good audiological result.

Cochlear implantation in maternal inherited diabetes and deafness syndrome.

We describe a rare case of a gradually progressive hearing loss in a patient with maternally inherited diabetes and deafness (MIDD) syndrome successfully rehabilitated with a cochlear implant. The possible aetiology of the hearing loss in these cases is discussed.

Cochlear implantation under local anaesthesia, the Belfast experience.

The profoundly deaf, who gain little or no benefit from conventional hearing aids and meet various criteria are potential candidates for cochlear implantation. The last two decades have witnessed remarkable progress in this field, and it is now a routine clinical procedure. A few adult patients who are potential candidates for cochlear implantation have an unacceptably high risk for hypotensive general anaesthesia due to other systemic conditions. This group has been successfully implanted under local anaesthesia in our centre. The post-implantation progress of these patients was comparable to those carried out under hypotensive general anaesthesia. Data regarding patient selection criteria, examination, anaesthesia, surgery and the outcome are discussed. It was concluded that cochlear implantation under local anaesthesia is a safe and effective procedure for those patients who otherwise may be denied an implant.

Cochlear implantation following temporal bone fracture.

Seven cases of profound hearing impairment following either unilateral or bilateral temporal bone fracture are presented who were implanted with the Nucleus 22 channel or Ineraid devices. Six patients suffered bilateral temporal bone fractures. One patient had prior congenital unilateral profound hearing impairment. This patient suffered a unilateral temporal bone fracture. Six patients became regular users of their implants. One gained little benefit and became a non-user. Two of the regular users experienced facial nerve stimulation, which could not be programmed out. In these two cases the implant was removed and the contralateral ear successfully implanted. Implant-aided audiometry demonstrated a hearing threshold of 40-50 dB at nine months after switch-on. The reliability of computed tomography (CT) scanning in predicting cochlear patency in cases of temporal bone fracture will be discussed. The benefit of complimentary imaging with magnetic resonance (MR) is highlighted.

Posterior fossa vestibular neurectomy.

Many procedures have been devised to deal with intractable vertigo and conserve hearing, but despite this selective vestibular nerve section remains by far the most effective treatment. A series of 14 patients who underwent posterior fossa vestibular neurectomy is reported. The results are reported for vertigo control, hearing and tinnitus. All of the patients achieved vertigo control according to the AAOO (1972) reporting system. A simple and reliable system for the classification of the disability in these patients has yet to be devised. This problem is addressed and a disability grading system proposed, and discussed.

Role and results of cortical mastoidectomy and endolymphatic sac surgery in Menière's disease.

It is almost impossible to establish the natural history of Menière's disease and, by the same token, it is difficult to confirm the efficacy of endolymphatic sac surgery. The authors doubt the logic of sac operations. Only two controlled trials of sac surgery have been found and both cast doubt upon its value. There do not appear to be any controlled trials indicating that it works. In 14 cases of incapacitating Menière's disease, where vestibular nerve section was indicated, cortical mastoidectomy was offered and accepted in the expectation that two-thirds might be spared the more major procedure. In the event, the vertigo was controlled in eight out of 14 (57 per cent), the remaining six (43 per cent) requiring more major surgery. A surgical model illustrates that, of themselves, these results are essentially meaningless in assessing the efficacy of cortical mastoidectomy in Menière's disease. Until all cases in a community are considered and followed-up, we shall be in doubt about the value of sac surgery and most other treatments of Menière's disease.

Management of otoscierosis--an Irish perspective.

The last 30 years have seen a gradual change in the management of otosclerosis. The aim of this study is to evaluate the current practice amongst Irish otolaryngology consultants by a questionnaire and to compare it with the practice currently followed in Great Britain. Thirty-eight responses (67.9%) were available for analysis. The overall trend is towards centralisation with a reduction in the number of surgeons undertaking stapes surgery (39%). The majority of consultants (67%) who undertake stapes surgery would operate for a unilateral conductive loss and 67% would undertake bilateral stapes surgery. Stapedotomy is the only operation performed (100%) with none of the consultants performing partial or total stapedectomies.

Cochlear implantations in Northern Ireland: an overview of the first five years.

During the last few years cochlear implantation (CI) has made remarkable progress, developing from a mere research tool to a viable clinical application. The Centre for CI in the Northern Ireland was established in 1992 and has since been a provider of this new technology for rehabilitation of profoundly deaf patients in the region. Although individual performance with a cochlear implant cannot be predicted accurately, the overall success of CI can no longer be denied. Seventy one patients, 37 adults and 34 children, have received implants over the first five years of the Northern Ireland cochlear implant programme, which is located at the Belfast City Hospital. The complication rates and the post-implantation outcome of this centre compare favourably with other major centres which undertake the procedure. This paper aims to highlight the patient selection criteria, surgery, post-CI outcome, clinical and research developments within our centre, and future prospects of this recent modality of treatment.

Belfast Cochlear Implant Centre; the surgical results of the first 100 implants.

We assess the surgical results of the first one hundred cochlear implant operations at the Belfast Cochlear Implant Centre. This paper is in the form of a retrospective case series, taking into account the surgical technique used and any problems encountered. Initially 28 operations were performed using the standard inverted U-shaped incision. After Gibson and Harrison described a vertical postaural incision we began using a slight modification of this technique for any further implantations. Since November 1994 the vertical post aural skin incision has been used in 71 patients. The surgical complications of cochlear implantation include haematoma, wound infection and flap necrosis of varying degrees of severity. We report a low level of these complications, particularly with the vertical incision.

Cochlear implantation in keratitis-ichthyosis-deafness syndrome: 10-year follow-up of two patients.

OBJECTIVE AND IMPORTANCE: The objective of this study was to describe long-term outcomes after cochlear implantation in keratitis-ichthyosis-deafness (KID) syndrome, often caused by GJB2 mutations, in the context of other reported cases. Clinical presentation and intervention: The authors conducted correlative clinical and molecular genetic analysis on two implanted patients with KID syndrome, and tabulated their clinical outcomes. Both children had initially successful surgery. In one case, due to skin-related problems, despite extensive salvage surgery cochlear explantation was required. This patient now communicates with sign language and lip-reading. This contrasts with the outcome for the other patient whereby at post-operative year 10 he is able to easily converse by telephone. Both patients each carry a de novo 148G > A GJB2 mutation. CONCLUSION: Patients with KID syndrome appear to be good candidates for cochlear implantation but may face significant skin-related problems which could disrupt successful post-operative habilitation. Consultation with dermatological colleagues regarding any new therapies may be warranted.

Cochlear Implantation in Brown-Vialetto-Van-Laere syndrome.

OBJECTIVE: To report outcomes for the first known cochlear implantation procedures in two patients with Brown-Vialetto-Van-Laere syndrome. PATIENTS: Two adult patients (a brother and sister) with post-lingual sensorineural deafness associated with Brown-Vialetto-Van-Laere syndrome. The female patient presented with a milder form of the syndrome. INTERVENTION: Cochlear implantation. MAIN OUTCOME MEASURE: Post-implantation speech discrimination scores. RESULTS: Auditory evoked potential testing suggested pathological changes in both patients' cochleae, auditory nerves, brainstem and (probably) central auditory pathways. In the male patient, despite implantation of the better ear, the Bamford-Kowal-Bench sentence score was zero at 21 months post-implantation. In the female patient, Bamford-Kowal-Bench sentence scores at six months post-implantation were 25 per cent in quiet and 3 per cent in noise. CONCLUSION: These poor clinical outcomes appear to be related to retrocochlear and probable central auditory pathway degeneration.