Tonsillectomy: a cost-effective option for childhood sore throat? Further analysis of a randomized controlled trial.

OBJECTIVE: To compare the estimated cost-effectiveness of childhood (adeno)tonsillectomy vs medical therapy for recurrent sore throats from the intention-to-treat (ITT) analysis of a randomized controlled trial (RCT) with that modeled on the recorded timing of surgical interventions as observed in all participants irrespective of their original group allocation. STUDY DESIGN: A pragmatic RCT (trial) with a parallel nonrandomized patient preference group (cohort) of (adeno)tonsillectomy vs medical therapy. SETTING: Five secondary care UK otolaryngology departments. SUBJECTS AND METHODS: Eligible children, aged 4 to 15 years, were enrolled to the trial (268) or cohort (461) groups. Outcomes included sore throat diaries, quality of life, and general practice consultations. The RCT protocol ITT analysis was compared with an as-treated analysis incorporating the cohort group, modeled to reflect the timing of tonsillectomy and the differential switch rates among the original groups. RESULTS: In the RCT ITT analysis, tonsillectomy saved 3.5 sore throats, whereas the as-treated model suggested an average reduction of more than 8 sore throats in 2 years for surgery within 10 weeks of consultation, falling to only 3.5 twelve months later due to the spontaneous improvement in the medical therapy group. CONCLUSION: In eligible UK school-age children, tonsillectomy can save up to 8 sore throats at a reasonable cost, if performed promptly. Further prospective data collection, accounting for baseline and per-trial preferences and choice, is urgently needed.

Childhood tonsillectomy: who is referred and what treatment choices are made? Baseline findings from the North of England and Scotland Study of Tonsillectomy and Adenotonsillectomy in Children (NESSTAC).

BACKGROUND: Tonsillectomies are frequently performed, yet variations exist in tonsillectomy rates. Clinicians use guidelines, but complex psychosocial influences on childhood tonsillectomy include anecdotal evidence of parental enthusiasm. Studies indicate that undergoing preferred treatment improves outcome. Despite the enthusiasm with which tonsillectomy is offered and sought, there is little evidence of efficacy. This resulted in a randomised controlled trial to evaluate the cost-effectiveness of (adeno)tonsillectomy in children with recurrent sore throats. OBJECTIVE: To compare characteristics of children entering the randomised trial with those recruited to a parallel, non-randomised study, to establish trends in referral and patient preferences for treatment. DESIGN: Baseline data from a randomised controlled trial with parallel non-randomised preference study, comparing surgical intervention with medical treatment in children aged 4-15 years with recurrent sore throat referred to five secondary care otolaryngology departments located in the north of England or west central Scotland. RESULTS: Centres assessed 1546 children; 21% were not eligible for tonsillectomy. Among older children (8-15 years), girls were significantly more likely to be referred to secondary care. Of 1015 eligible children, 268 (28.2%) agreed to be randomised, while 461 (45.4%) agreed to the parallel, non-randomised preference study, with a strong preference for tonsillectomy. Participants reporting that progress at school had been impeded or with more experience of persistent sore throat were more likely to seek tonsillectomy. Referred boys were more likely than girls to opt for medical treatment. Socio-economic data showed no effect. CONCLUSION: Preference for tonsillectomy reflects educational impact and recent experience, rather than age or socio-economic status.

Protocol for north of England and Scotland study of tonsillectomy and adeno-tonsillectomy in children (NESSTAC). A pragmatic randomised controlled trial comparing surgical intervention with conventional medical treatment in children with recurrent sore throats.

BACKGROUND: Uncertainties surrounding the effectiveness and cost-effectiveness of childhood tonsillectomy for recurrent sore throat led the NHS Health Technology Assessment Programme to commission this research to evaluate the effectiveness and cost-effectiveness of tonsillectomy and adeno-tonsillectomy in comparison with standard non-surgical management in children aged under 16 with recurrent throat infections. The aim is to evaluate if tonsillectomy and adeno-tonsillectomy reduces the number of episodes of sore throats among children to a clinically significant extent. METHODS/DESIGN: A simple prospective pragmatic randomised controlled trial with economic analysis and prospective cohort study of non-trial participants comparing surgical intervention with conventional medical treatment. The treatment arm will receive tonsillectomy and adeno-tonsillectomy while in the control arm non-surgical conventional medical treatment only will be used. The primary outcome measure will be reported number of episodes of sore throat over two years with secondary outcomes measures of reported number of episodes of sore throat, otitis media and upper respiratory tract infection which invoke a GP consultation; reported number of symptom-free days; reported severity of sore throats and surgical and anaesthetic morbidity. The study will take place in five hospitals in the UK. The trial population will be 406 children aged 4-15 on their last birthday with recurrent sore throat referred by primary care to the 5 otolaryngology departments. The duration of the study is seven years (July 2001-July 2008). DISCUSSION: As with all pragmatic randomised controlled trials it is impossible to control the external environment in which the research is taking place. Since this trial began a number of factors have arisen which could affect the outcome including; a reduction in the incidence of respiratory tract infections, marked socio-economic differences in consultation rates, the results from the National Prospective Tonsillectomy Audit and the Government's waiting list initiatives.

Implementation of brief alcohol interventions by nurses in primary care: do non-clinical factors influence practice?

BACKGROUND: In the UK, GPs and practice nurses selectively provide brief alcohol interventions to risk drinkers. GPs' provision of a brief alcohol intervention can be predicted by patient characteristics, practitioner characteristics and structural factors such as the features of the practice and how it is organized. However, much less is known about possible modifiers of nurse practice. OBJECTIVE: Our aim was to investigate if patient characteristics, nurse characteristics and practice factors influence provision of a brief alcohol intervention by practice nurses in primary health care. METHODS: One hundred and twenty-eight practice nurses who had implemented a brief alcohol intervention programme in a previous trial based in the North of England were requested to screen adults presenting to their surgery and follow a structured protocol to give a brief intervention (5 min of advice plus an information booklet) to all 'risk' drinkers. Anonymized carbon copies of 5541 completed Alcohol Use Disorders Identification Test (AUDIT) screening questionnaires were collected after a 3-month implementation period and analysed by logistic regression analysis. RESULTS: Although AUDIT identified 1500 'risk' drinkers, only 926 (62%) received a brief intervention. Logistic regression modelling showed that patients' risk status as measured by AUDIT score was the most influential predictor of a brief intervention by practice nurses. However, risk drinkers who were most likely to receive a brief intervention were male. Patients' age or social class did not independently predict a brief intervention. The multilevel model was unable to identify any independent nurse characteristics that could predict a brief intervention, but indicated significant variation between nurses in their tendency to offer the intervention to patients. No structural factors were found to be positively associated with selective provision. CONCLUSIONS: Patient and nurse factors contributed to the selective provision of a brief intervention in primary care. If patients are to experience the beneficial effects of a brief alcohol intervention, then there is a need to improve the accuracy of delivery.

Promoting brief alcohol intervention by nurses in primary care: a cluster randomised controlled trial.

This trial evaluated the clinical impact and cost-effectiveness of strategies promoting screening and brief alcohol intervention (SBI) by nurses in primary care. Randomisation was at the level of the practice and the interventions were: written guidelines (controls, n=76); outreach training (n=68); and training plus telephone-based support (n=68). After 3 months, just 39% of controls implemented the SBI programme compared to 74% of nurses in trained practices and 71% in trained and supported practices. Controls also screened fewer patients and delivered fewer brief interventions to risk drinkers than other colleagues. However, there was a trade-off between the extent and the appropriateness of brief intervention delivery with controls displaying the least errors in overall patient management. Thus cost-effectiveness ratios (cost per patient appropriately treated) were similar between the three strategies. Given the potential for anxiety due to misdirected advice about alcohol-related risk, the balance of evidence favoured the use of written guidelines to promote SBI by nurses in primary care.