The inter-rater reliability of the diagnosis of surgical site infection in the context of a clinical trial.

OBJECTIVES: The diagnosis of surgical site infection following endoprosthetic reconstruction for bone tumours is frequently a subjective diagnosis. Large clinical trials use blinded Central Adjudication Committees (CACs) to minimise the variability and bias associated with assessing a clinical outcome. The aim of this study was to determine the level of inter-rater and intra-rater agreement in the diagnosis of surgical site infection in the context of a clinical trial. MATERIALS AND METHODS: The Prophylactic Antibiotic Regimens in Tumour Surgery (PARITY) trial CAC adjudicated 29 non-PARITY cases of lower extremity endoprosthetic reconstruction. The CAC members classified each case according to the Centers for Disease Control (CDC) criteria for surgical site infection (superficial, deep, or organ space). Combinatorial analysis was used to calculate the smallest CAC panel size required to maximise agreement. A final meeting was held to establish a consensus. RESULTS: Full or near consensus was reached in 20 of the 29 cases. The Fleiss kappa value was calculated as 0.44 (95% confidence interval (CI) 0.35 to 0.53), or moderate agreement. The greatest statistical agreement was observed in the outcome of no infection, 0.61 (95% CI 0.49 to 0.72, substantial agreement). Panelists reached a full consensus in 12 of 29 cases and near consensus in five of 29 cases when CDC criteria were used (superficial, deep or organ space). A stable maximum Fleiss kappa of 0.46 (95% CI 0.50 to 0.35) at CAC sizes greater than three members was obtained. CONCLUSIONS: There is substantial agreement among the members of the PARITY CAC regarding the presence or absence of surgical site infection. Agreement on the level of infection, however, is more challenging. Additional clinical information routinely collected by the prospective PARITY trial may improve the discriminatory capacity of the CAC in the parent study for the diagnosis of infection.Cite this article: J. Nuttall, N. Evaniew, P. Thornley, A. Griffin, B. Deheshi, T. O'Shea, J. Wunder, P. Ferguson, R. L. Randall, R. Turcotte, P. Schneider, P. McKay, M. Bhandari, M. Ghert. The inter-rater reliability of the diagnosis of surgical site infection in the context of a clinical trial. Bone Joint Res 2016;5:347-352. DOI: 10.1302/2046-3758.58.BJR-2016-0036.R1.

An international survey to identify the intrinsic and extrinsic factors of research studies most likely to change orthopaedic practice.

OBJECTIVES: Evidence -based medicine (EBM) is designed to inform clinical decision-making within all medical specialties, including orthopaedic surgery. We recently published a pilot survey of the Canadian Orthopaedic Association (COA) membership and demonstrated that the adoption of EBM principles is variable among Canadian orthopaedic surgeons. The objective of this study was to conduct a broader international survey of orthopaedic surgeons to identify characteristics of research studies perceived as being most influential in informing clinical decision-making. MATERIALS AND METHODS: A 29-question electronic survey was distributed to the readership of an established orthopaedic journal with international readership. The survey aimed to analyse the influence of both extrinsic (journal quality, investigator profiles, etc.) and intrinsic characteristics (study design, sample size, etc.) of research studies in relation to their influence on practice patterns. RESULTS: A total of 353 surgeons completed the survey. Surgeons achieved consensus on the 'importance' of three key designs on their practices: randomised controlled trials (94%), meta-analyses (75%) and systematic reviews (66%). The vast majority of respondents support the use of current evidence over historical clinical training; however subjective factors such as journal reputation (72%) and investigator profile (68%) continue to influence clinical decision-making strongly. CONCLUSION: Although intrinsic factors such as study design and sample size have some influence on clinical decision-making, surgeon respondents are equally influenced by extrinsic factors such as investigator reputation and perceived journal quality.Cite this article: Dr M. Ghert. An international survey to identify the intrinsic and extrinsic factors of research studies most likely to change orthopaedic practice. Bone Joint Res 2016;5:130-136. DOI: 10.1302/2046-3758.54.2000578.

Explaining diet as a risk factor for periodontal disease in primary dental care.

AIMS AND OBJECTIVES: An audit was carried out to assess the delivery of dietary advice in general dental practice for patients diagnosed with chronic/aggressive periodontitis, with the objective of finding ways to deliver dietary advice and improve patient education on a potentially important modifiable risk factor. METHODOLOGY: Following a retrospective pilot sample, an initial sample of 50 patients (of dentists, a dental therapist and dental hygienist) was selected. The delivery of dietary advice and the method by which it was given was recorded as part of the data set. A semi-structured interview was also completed to discuss various aspects of delivering dietary advice. A staff meeting was carried out following the first cycle to raise awareness and inform on the link between diet and periodontal disease. Following this a second cycle was carried out to complete the audit cycle and the results were analysed. RESULTS: It was evident that following the first cycle dietary advice was not being given with respect to periodontal prevention. While the standard set was not met following re-audit there was significant improvement in the delivery of dietary advice as well as different ways to deliver the information. The feedback from the semi-structured interview suggested various obstacles in delivering dietary advice including lack of knowledge at first and also overloading patients with too much information initially. CONCLUSION: Using the entire dental team can be an effective way of educating our patients on risk factors for periodontal disease. It is important to note that this audit focused on clinicians delivering the advice and future direction should consider patient compliance and uptake of information.

A qualitative evaluation of foundation dentists' and training programme directors' perceptions of clinical audit in general dental practice.

This study reports on an investigation into clinical audit (CA) educational and service delivery outcomes in a dental foundation training (DFT) programme. The aim was to investigate CA teaching, learning and practice from the perspective of foundation dentists (FDs) and to record suggestions for improvement. A qualitative research methodology was used. Audio recordings of focus group interviews with FDs were triangulated by an interview with a group of training programme directors (TPDs). The interviews were transcribed and thematically analysed using a 'Framework' approach within Nvivo Data Analysis Software. FDs report considerable learning and behaviour change. However, TPDs have doubts about the long-term effects on service delivery. There can be substantial learning in the clinical, managerial, communication and professionalism domains, and in the development of time management, organisational and team-working skills. Information is provided about use of resources and interaction with teachers and colleagues. CA provides learning opportunities not produced by other educational activities including 'awkward conversations' with team-members in the context of change management and providing feedback. This is relevant when applying the recommendations of the Francis report. This paper should be useful to any dentist conducting audit or team training. Suggestions are made for improvements to resources and support including right touch intervention. Trainers should teach in the 'Goldilocks Zone'.

Laryngeal tuberculosis: A case of a non-healing laryngeal lesion.

We report a case of laryngeal tuberculosis in a 47-year-old Korean man. Laryngeal tuberculosis is rare and currently accounts for less than 1% of all cases of tuberculosis. Clinical features of laryngeal tuberculosis include hoarseness, odynophagia and dyspnoea. Macroscopically, laryngeal tuberculosis may mimic laryngeal carcinoma, chronic laryngitis or laryngeal candidiasis. The diagnosis is often delayed due to a low index of clinical suspicion and hence may pose a significant public health risk. Laryngeal tuberculosis should be considered in the differential diagnosis of patients who present with any form of laryngeal lesion.

The survival of Class V restorations in general dental practice: part 3, five-year survival.

OBJECTIVE: To evaluate the survival over five years of Class V restorations placed by UK general practitioners, and to identify factors associated with increased longevity. DESIGN: Prospective longitudinal cohort multi-centre study. SETTING: UK general dental practices. MATERIALS AND METHOD: Ten general dental practitioners each placed 100 Class V restorations of varying sizes, using a range of materials and recorded selected clinical information at placement and recall visits. After five years the data were analysed using the Kaplan-Meier method, log-rank tests and Cox regressions models to identify significant associations between the time to restoration failure and different clinical factors. RESULTS: After five years 275/989 restorations had failed (27.8%), with 116 (11.7%) lost to follow-up. Cox regression analysis identified that, in combination, the practitioner, patient age, cavity size, moisture contamination and cavity preparation were found to influence the survival of the restorations. CONCLUSIONS: At least 60.5% of the restorations survived for five years. The time to failure of Class V restorations placed by this group of dentists was reduced in association with the individual practitioner, smaller cavities, glass ionomer restorations, cavities which had not been prepared with a bur, moisture contamination, increasing patient age, cavities confined to dentine and non-carious cavities.

The survival of Class V restorations in general dental practice. Part 2, early failure.

OBJECTIVE: To evaluate Class V restorations placed by UK general practitioners comparing those failing or surviving after two years, and to identify factors associated with early failure. DESIGN: Prospective longitudinal cohort multi-centre study. Setting UK general dental practices. MATERIALS & METHODS: Ten dentists each placed 100 Class V restorations and recorded selected clinical information at placement and recall visits. Univariate associations were assessed between recorded clinical factors and whether restorations had failed or not at two years. Multi-variable binary logistic regression was also undertaken to identify which combination of factors had a significant effect on the probability of early failure. RESULTS: At two years, 156 of 989 restorations had failed (15.8%), with 40 (4%) lost to follow-up. Univariate analysis showed a significant association between restoration failure and increasing patient age, payment method, the treating practitioner, non-carious cavities, cavities involving enamel and dentine, cavity preparation and restoration material. Multi-variable analysis indicated a higher probability of early failure associated with the practitioner, older patients, glass ionomer and flowable composite, bur-preparation and moisture contamination. CONCLUSIONS: Among these practitioners, both analytic methods identified significant associations between early failure of Class V restorations and the practitioner, cavity preparation method, restoration material and patient's age.

The survival of Class V restorations in general dental practice. Part 1, baseline data.

OBJECTIVE: Evidence on the survival of different restorations in general practice is scarce and so to address this need, a study was designed to monitor the outcome of Class V restorations placed in UK general practices. DESIGN: Prospective longitudinal cohort multi-centre study. SETTING: UK general dental practice. MATERIALS AND METHODS: Ten UK dentists each placed 100 Class V restorations and recorded selected clinical information at placement and at recall visits on record cards. Dentists selected materials and techniques which they felt appropriate to each clinical situation. RESULTS: Data cards for 11 restorations were incorrectly completed or information was missing leaving 989 for analysis. The majority of restorations were placed in patients between 51 and 60 years of age, in canines or premolars (68.4%) and under private contract (63%). Composite (40.85%) and compomer (23.46%) were the most frequently placed materials overall but were not the most frequently placed restorative by some dentists. CONCLUSIONS: Different dentists use different methods to manage Class V lesions but each dentist tends to use one restorative material predominantly. There is a degree of overlap among practitioners in the materials which they employ, but clear preferences were displayed in the materials used and handling techniques.

Assessing the quality of radiographic processing in general dental practice.

OBJECTIVES: To determine if a commercial device (Vischeck) for monitoring film processing quality was a practical option in general dental practice, and to assess processing quality among a group of GDPs in the West Midlands with this device. DESIGN: Clinical evaluation. SETTING: General dental practice, UK, 2004. METHOD: Ten GDP volunteers from a practice based research group processed Vischeck strips (a) when chemicals were changed, (b) one week later, and (c) immediately before the next change of chemicals. These were compared with strips processed under ideal conditions. Additionally, a series of duplicate radiographs were produced and processed together with Vischeck strips in progressively more dilute developer solutions to compare the change in radiograph quality assessed clinically with that derived from the Vischeck. RESULTS: The Vischeck strips suggested that at the time chosen for change of processing chemicals, eight dentists had been processing films well beyond the point indicated for replacement. Solutions were changed after a wide range of time periods and number of films processed. The calibration of the Vischeck strip correlated closely to a clinical assessment of acceptable film quality. CONCLUSIONS: Vischeck strips are a useful aid to monitoring processing quality in automatic developers in general dental practice. Most of this group of GDPs were using chemicals beyond the point at which diagnostic yield would be affected.

Organizing a practice-based research group.

There is an urgent need for more dental research to come from the 'real-life' setting of general practice in order to complement the information arising from laboratory testing and institution-based clinical trials. This paper outlines some of the problems and opportunities encountered in undertaking research in practice, and describes the experiences of one such practice-based research group.

Adaptive resistance to tobramycin in Pseudomonas aeruginosa lung infection in cystic fibrosis.

Aminoglycoside antibiotics have been shown to induce adaptive resistance in Pseudomonas aeruginosa in vitro and in a mouse model of infection, but adaptive resistance has not been described in human infections. Seven patients with cystic fibrosis were treated with inhaled tobramycin to determine whether adaptive resistance occurred in P. aeruginosa in their sputum. In three patients who had not recently taken antibiotics, 80 mg tobramycin was administered by nebuliser and resulting peak sputum tobramycin concentrations were 90-240 mg/L (elimination half-life 1.9-2.1 h). Adaptive resistance was detected in P. aeruginosa 1-4 h after the dose of tobramycin. Moderate resistance was present at 24 h and full susceptibility returned between 24 and 48 h. In four other patients on long-term twice-daily inhaled aminoglycoside treatment, adaptive resistance was present before, and 4 h after, 80 mg of tobramycin administered by nebuliser. The presence and time course of adaptive resistance in humans may have implications for improving aminoglycoside dosing regimens.

Measurement of insulin wastage in five Ontario hospitals.

This study was designed to determine the extent of insulin wastage and the extrapolated cost of wastage for Ontario hospitals. The five hospitals in the study were chosen to include differences in patient mix and drug distribution systems. Beginning and ending inventories of all insulin types were taken spanning a six-week period. The quantity of insulin dispensed and wasted during this time period was recorded. Partial vials were measured using a calibrated scale. Wastage was calculated as insulin discarded divided by the amount of insulin used in the time period. Insulin wastage averaged 34.1%. This was equivalent to up to $8,000 a year for the largest hospital surveyed and translates to an estimated cost of $360,000 a year in all Ontario hospitals. Therefore, hospitals should estimate their insulin wastage and seek ways to reduce it. The pharmaceutical industry should be encouraged to develop cost-effective insulin delivery systems.

A community wide promotion of asthma self management: process evaluation.

AIMS: During the months February through July 1991, a community wide promotion of asthma self-management was undertaken as a pilot study for the national launch of an asthma action plan developed by the Asthma Foundation of New Zealand in conjunction with the Royal New Zealand College of General Practitioners. METHODS: A multidisciplinary team of hospital and community-based health workers was established, with the aim of educating and resourcing general practitioners, practice nurses and retail pharmacists to enable them to effectively promote and distribute the asthma action plan. 332 general practitioners and 148 retail pharmacists were surveyed through postal and telephone questionnaires at the completion of the promotion, to assess its impact on health professionals and to obtain feedback for the national promotion of the asthma action plan. RESULTS: 108 (73%) of pharmacists who responded and were involved with the promotion found their participation to be worthwhile, although some had difficulty allocating sufficient time to give detailed advice to patients. Of the 240 general practitioners who responded, 77% indicated that they had used the asthma action plan with their patients. They were positive about the use of the workshop format that had provided education and resources for the plan, and of those that had used the plan, 94% indicated that they would continue to promote the plan, or one similar. CONCLUSIONS: The promotion of the asthma action plan in Canterbury had a major impact on health professionals. The community-wide promotion might have had a greater impact on people with asthma had television advertising been used. The pilot project provided useful feedback for the Asthma Foundation in their preparation for the national launch.

Comparison of nedocromil sodium at two dosage frequencies with placebo in the management of chronic asthma.

Nedocromil sodium (4 mg b.d. or q.i.d.) was added to the therapy of 76 chronic asthmatic patients in a four-centre, double-blind cross-over, placebo-controlled trial. Patients had troublesome symptoms uncontrolled by high doses of inhaled corticosteroids (mean 1450 micrograms). In 54 patients who completed the study, nedocromil sodium was significantly more efficacious than placebo (P < 0.01) in relieving morning chest-tightness and cough, in reducing total diary card score and nocturnal bronchodilator usage, and in increasing morning and evening peak flow. Asthma severity at clinic visits decreased significantly (P = 0.001) following treatment with nedocromil sodium, which was globally rated more effective than placebo (P < 0.01). Treatment differences favored q.i.d. over b.d. dosage but without statistical significance. There were no serious adverse effects. Although the pulmonary function changes were small, these findings suggest that the addition of nedocromil sodium may benefit asthmatic patients who are inadequately controlled by high doses of inhaled corticosteroids.

Amoxycillin-clavulanic acid combination in bronchopulmonary infection due to beta-lactamase-producing Branhamella catarrhalis. Preliminary report.

Since 1978 we have taken an interest in lower respiratory tract infections associated with Branhamella catarrhalis in Christchurch, New Zealand. In a preliminary trial, 20 patients with bronchopulmonary infection caused by beta-lactamase-producing B. catarrhalis were treated with a combination tablet of amoxycillin 500 mg and clavulanic acid 125 mg ('Augmentin') 3 times daily for 5 days. Sputum cultures were negative for B. catarrhalis within 3 days in all patients. Two of 7 patients whose sputum cultures were positive for this organism at a review 2 to 4 weeks later were successfully treated with a further course of amoxycillin/clavulanic acid.