PMCC PMCC

Search tips
Search criteria

Advanced
Results 1-21 (21)
 

Clipboard (0)
None

Select a Filter Below

Journals
Year of Publication
more »
Document Types
author:("muller, Mark")
1.  A population-based survival analysis describing the association of body mass index on time to revision for total hip and knee replacements: results from the UK general practice research database 
BMJ Open  2013;3(11):e003614.
Objectives
Against a backdrop of rising levels of obesity, we describe and estimate associations of body mass index (BMI), age and gender with time to revision for participants undergoing primary total hip (THR) or knee (TKR) replacement in the UK.
Design
Population-based cohort study.
Setting
Routinely collected primary care data from a representative sample of general practices, including linked data on all secondary care events.
Participants
Population-based cohort study of 63 162 patients with THR and 54 276 with TKR in the UK General Practice Research Database between 1988 and 2011.
Primary and secondary outcomes
Risk of THR and TKR revision associated with BMI, age and gender, after adjusting for the competing risk of death.
Results
The 5-year cumulative incidence rate for THR was 2.2% for men and 1.8% for women (TKR 2.3% for men, 1.6% for women). The adjusted overall subhazard ratio (SHR) for patients with THR undergoing subsequent hip revision surgery, with a competing risk of death, were estimated at 1.020 (95% CI 1.009 to 1.032) per additional unit (kg/m2) of BMI, 1.23 (95% CI 1.10 to 1.38) for men compared with women and 0.970 (95% CI 0.967 to 0.973) per additional year of age. For patients with TKR, the equivalent estimates were 1.015 (95% CI 1.002 to 1.028) for BMI; 1.51 (95% CI 1.32 to 1.73) for gender and 0.957 (95% CI 0.951 to 0.962) for age. Morbidly obese patients with THR had a 65.5% increase (95% CI 15.4% to 137.3%, p=0.006) in the subhazard of revision versus the normal BMI group (18.5–25). The effect for TKR was smaller (a 43.9% increase) and weaker (95% CI 2.6% to 103.9%, p=0.040).
Conclusions
BMI is estimated to have a small but statistically significant association with the risk of hip and knee revision, but absolute numbers are small. Further studies are needed in order to distinguish between effects for specific revision surgery indications.
doi:10.1136/bmjopen-2013-003614
PMCID: PMC3845068  PMID: 24285628
2.  Incidence and clinical variables associated with streptococcal throat infections: a prospective diagnostic cohort study 
The British Journal of General Practice  2012;62(604):e787-e794.
Background
Management of pharyngitis is commonly based on features which are thought to be associated with Lancefield group A beta-haemolytic streptococci (GABHS) but it is debatable which features best predict GABHS. Non-group A strains share major virulence factors with group A, but it is unclear how commonly they present and whether their presentation differs.
Aim
To assess the incidence and clinical variables associated with streptococcal infections.
Design and setting
Prospective diagnostic cohort study in UK primary care.
Method
The presence of pathogenic streptococci from throat swabs was assessed among patients aged ≥5 years presenting with acute sore throat.
Results
Pathogenic streptococci were found in 204/597 patients (34%, 95% CI = 31 to 38%): 33% (68/204) were non-group A streptococci, mostly C (n = 29), G (n = 18) and B (n = 17); rarely D (n = 3) and Streptococcus pneumoniae (n = 1). Patients presented with similar features whether the streptococci were group A or non-group A. The features best predicting A, C or G beta-haemolytic streptococci were patient’s assessment of severity (odds ratio [OR] for a bad sore throat 3.31, 95% CI = 1.24 to 8.83); doctors’ assessment of severity (severely inflamed tonsils OR 2.28, 95% CI = 1.39 to 3.74); absence of a bad cough (OR 2.73, 95% CI = 1.56 to 4.76), absence of a coryza (OR 1.54, 95% CI = 0.99 to 2.41); and moderately bad or worse muscle aches (OR 2.20, 95% CI = 1.41 to 3.42).
Conclusion
Non-group A strains commonly cause streptococcal sore throats, and present with similar symptomatic clinical features to group A streptococci. The best features to predict streptococcal sore throat presenting in primary care deserve revisiting.
doi:10.3399/bjgp12X658322
PMCID: PMC3481520  PMID: 23211183
pharyngitis; primary care; tonsillitis; streptococcus
3.  PRImary care Streptococcal Management (PRISM) study: identifying clinical variables associated with Lancefield group A β-haemolytic streptococci and Lancefield non-Group A streptococcal throat infections from two cohorts of patients presenting with an acute sore throat 
BMJ Open  2013;3(10):e003943.
Objective
To assess the association between features of acute sore throat and the growth of streptococci from culturing a throat swab.
Design
Diagnostic cohort.
Setting
UK general practices.
Participants
Patients aged 5 or over presenting with an acute sore throat. Patients were recruited for a second cohort (cohort 2, n=517) consecutively after the first (cohort 1, n=606) from similar practices.
Main outcome
Predictors of the presence of Lancefield A/C/G streptococci.
Results
The clinical score developed from cohort 1 had poor discrimination in cohort 2 (bootstrapped estimate of area under the receiver operator characteristic (ROC) curve (0.65), due to the poor validity of the individual items in the second data set. Variables significant in multivariate analysis in both cohorts were rapid attendance (prior duration 3 days or less; multivariate adjusted OR 1.92 cohort, 1.67 cohort 2); fever in the last 24 h (1.69, 2.40); and doctor assessment of severity (severely inflamed pharynx/tonsils (2.28, 2.29)). The absence of coryza or cough and purulent tonsils were significant in univariate analysis in both cohorts and in multivariate analysis in one cohort. A five-item score based on Fever, Purulence, Attend rapidly (3 days or less), severely Inflamed tonsils and No cough or coryza (FeverPAIN) had moderate predictive value (bootstrapped area under the ROC curve 0.73 cohort 1, 0.71 cohort 2) and identified a substantial number of participants at low risk of streptococcal infection (38% in cohort 1, 36% in cohort 2 scored ≤1, associated with a streptococcal percentage of 13% and 18%, respectively). A Centor score of ≤1 identified 23% and 26% of participants with streptococcal percentages of 10% and 28%, respectively.
Conclusions
Items widely used to help identify streptococcal sore throat may not be the most consistent. A modified clinical scoring system (FeverPAIN) which requires further validation may be clinically helpful in identifying individuals who are unlikely to have major pathogenic streptococci.
doi:10.1136/bmjopen-2013-003943
PMCID: PMC3808825  PMID: 24163209
Primary Care
4.  Effects of internet-based training on antibiotic prescribing rates for acute respiratory-tract infections: a multinational, cluster, randomised, factorial, controlled trial 
Lancet  2013;382(9899):1175-1182.
Summary
Background
High-volume prescribing of antibiotics in primary care is a major driver of antibiotic resistance. Education of physicians and patients can lower prescribing levels, but it frequently relies on highly trained staff. We assessed whether internet-based training methods could alter prescribing practices in multiple health-care systems.
Methods
After a baseline audit in October to December, 2010, primary-care practices in six European countries were cluster randomised to usual care, training in the use of a C-reactive protein (CRP) test at point of care, in enhanced communication skills, or in both CRP and enhanced communication. Patients were recruited from February to May, 2011. This trial is registered, number ISRCTN99871214.
Results
The baseline audit, done in 259 practices, provided data for 6771 patients with lower-respiratory-tract infections (3742 [55·3%]) and upper-respiratory-tract infections (1416 [20·9%]), of whom 5355 (79·1%) were prescribed antibiotics. After randomisation, 246 practices were included and 4264 patients were recruited. The antibiotic prescribing rate was lower with CRP training than without (33% vs 48%, adjusted risk ratio 0·54, 95% CI 0·42–0·69) and with enhanced-communication training than without (36% vs 45%, 0·69, 0·54–0·87). The combined intervention was associated with the greatest reduction in prescribing rate (CRP risk ratio 0·53, 95% CI 0·36–0·74, p<0·0001; enhanced communication 0·68, 0·50–0·89, p=0·003; combined 0·38, 0·25–0·55, p<0·0001).
Interpretation
Internet training achieved important reductions in antibiotic prescribing for respiratory-tract infections across language and cultural boundaries.
Funding
European Commission Framework Programme 6, National Institute for Health Research, Research Foundation Flanders.
doi:10.1016/S0140-6736(13)60994-0
PMCID: PMC3807804  PMID: 23915885
5.  Validating the prediction of lower urinary tract infection in primary care: sensitivity and specificity of urinary dipsticks and clinical scores in women 
Background
Dipsticks are one of the most commonly used near-patient tests in primary care, but few clinical or dipstick algorithms have been rigorously developed.
Aim
To confirm whether previously documented clinical and dipstick variables and algorithms predict laboratory diagnosis of urinary tract infection (UTI).
Design of study
Validation study.
Setting
Primary care.
Method
A total of 434 adult females with suspected lower UTI had bacteriuria assessed using the European Urinalysis Guidelines.
Results
Sixty-six per cent of patients had confirmed UTI. The predictive values of nitrite, leucocyte esterase (+ or greater), and blood (haemolysed trace or greater) were confirmed (independent multivariate odds ratios = 5.6, 3.5, and 2.1 respectively). The previously developed dipstick rule — based on presence of nitrite, or both leucocytes and blood — was moderately sensitive (75%) but less specific (66%; positive predictive value [PPV] 81%, negative predictive value [NPV] 57%). Predictive values were improved by varying the cut-off point: NPV was 76% for all three dipstick results being negative; the PPV was 92% for having nitrite and either blood or leucocyte esterase. Urine offensive smell was not found to be predictive in this sample; for a clinical score using the remaining three predictive clinical features (urine cloudiness, dysuria, and nocturia), NPV was 67% for none of the features, and PPV was 82% for three features.
Conclusion
A clinical score is of limited value in increasing diagnostic precision. Dipstick results can modestly improve diagnostic precision but poorly rule out infection. Clinicians need strategies to take account of poor NPVs.
doi:10.3399/bjgp10X514747
PMCID: PMC2894378  PMID: 20594439
algorithms, clinical scoring; diagnosis, urinary tract infection; primary care; urinalysis
6.  Cost effectiveness of management strategies for urinary tract infections: results from randomised controlled trial 
Objective To assess the cost effectiveness of different management strategies for urinary tract infections.
Design Cost effectiveness analysis alongside a randomised controlled trial with a one month follow-up.
Setting Primary care.
Participants 309 non-pregnant adult women aged 18-70 presenting with suspected urinary tract infection.
Interventions Patients were randomised to five basic management approaches: empirical antibiotics, empirical delayed (by 48 hours) antibiotics, or targeted antibiotics based on either a high symptom score (two or more of urine cloudiness, smell, nocturia, dysuria), dipstick results (nitrite or leucocytes and blood), or receipt of a positive result on midstream urine analysis.
Main outcome measure Duration of symptoms and cost of care.
Results Management with targeted antibiotics with midstream urine analysis was more costly over the period of one month. Costs for the midstream urine analysis and dipstick management groups were £37 and £35, respectively; these compared with £31 for immediate antibiotics. Cost effectiveness acceptability curves suggested that if avoiding a day of moderately bad symptoms was valued at less than £10, then immediate antibiotics is likely to be the most cost effective strategy. For values over £10, targeted antibiotics with dipstick testing becomes the most cost effective strategy, though because of the uncertainty we can never be more than 70% certain that this strategy truly is the most cost effective.
Conclusion Dipstick testing with targeted antibiotics is likely to be cost effective if the value of saving a day of moderately bad symptoms is £10 or more, but caution is required given the considerable uncertainty surrounding the estimates.
doi:10.1136/bmj.c346
PMCID: PMC2817048  PMID: 20139218
7.  An evaluation of the cost-effectiveness of booklet-based self-management of dizziness in primary care, with and without expert telephone support 
Background
Dizziness is a very common symptom that often leads to reduced quality of life, anxiety and emotional distress, loss of fitness, lack of confidence in balance, unsteadiness and an increased risk of falling. Most dizzy patients are managed in primary care by reassurance and medication to suppress symptoms. Trials have shown that chronic dizziness can be treated effectively in primary care using a self-help booklet to teach patients vestibular rehabilitation exercises that promote neurological adaptation and skill and confidence in balance. However, brief support from a trained nurse was provided in these trials, and this model of managing dizzy patients has not been taken up due to a lack of skills and resources in primary care. The aim of this trial is to evaluate two new alternative models of delivery that may be more feasible and cost-effective.
Methods/Design
In a single blind two-centre pragmatic controlled trial, we will randomise 330 patients from 30 practices to a) self-help booklet with telephone support from a vestibular therapist, b) self-help booklet alone, c) routine medical care. Symptoms, disability, handicap and quality of life will be assessed by validated questionnaires administered by post at baseline, immediately post-treatment (3 months), and at one year follow-up. The study is powered to test our primary hypothesis, that the self-help booklet with telephone support will be more effective than routine care. We will also explore the effectiveness of the booklet without any support, and calculate the costs of treatment in each arm.
Discussion
If our trial indicates that patients can cost-effectively manage their dizziness in primary care, then it can be easily rolled out to relieve the symptoms of the many patients in primary care who currently have chronic, untreated, disabling dizziness. Treatment in primary care may reduce the development of psychological and physical sequelae that cause handicap and require treatment. There is also the potential to reduce the cost to the NHS of treating dizziness by reducing demand for referral to secondary care for specialist assessment and treatment.
Trial Registration
ClinicalTrials.gov trial registration ID number: NCT00732797
doi:10.1186/1472-6815-9-13
PMCID: PMC2810289  PMID: 20098640
8.  Explaining the rise in antidepressant prescribing: a descriptive study using the general practice research database 
Objective To explore the reasons behind the recent increase in antidepressant prescribing in the United Kingdom.
Design Detailed retrospective analysis of data on general practitioner consultations and antidepressant prescribing.
Data source Data were obtained from the general practice research database, which contains linked anonymised records of over 3 million patients registered in the UK. Data were extracted for all new incident cases of depression between 1993 and 2005.
Review methods Detailed analysis of general practitioner consultations and antidepressant prescribing was restricted to 170 practices that were contributing data for the full duration of the study.
Results In total, 189 851 people within the general practice research database experienced their first episode of depression between 1993 and 2005, of whom 150 825 (79.4%) received a prescription for antidepressants in the first year of diagnosis. This proportion remained stable across all the years examined. The incidence of new cases of depression rose in young women but fell slightly in other groups such that overall incidence increased then declined slightly (men: 7.83 cases per 1000 patient years in 1993 to 5.97 in 2005, women: 15.83 cases per 1000 patient years in 1993 to 10.06 in 2005). Antidepressant prescribing nearly doubled during the study period—the average number of prescriptions issued per patient increased from 2.8 in 1993 to 5.6 in 2004. The majority of antidepressant prescriptions were given as long term treatment or as intermittent treatment to patients with multiple episodes of depression.
Conclusions The rise in antidepressant prescribing is mainly explained by small changes in the proportion of patients receiving long term treatment. Previous clinical guidelines have focused on antidepressant initiation and appropriate targeting of antidepressants. To address the costly rise in antidepressant prescribing, future research and guidance needs to concentrate on appropriate long term prescribing for depression and regular review of medication.
doi:10.1136/bmj.b3999
PMCID: PMC2762496  PMID: 19833707
9.  Developing clinical rules to predict urinary tract infection in primary care settings: sensitivity and specificity of near patient tests (dipsticks) and clinical scores 
Background
Suspected urinary tract infection (UTI) is one of the most common presentations in primary care. Systematic reviews have not documented any adequately powered studies in primary care that assess independent predictors of laboratory diagnosis.
Aim
To estimate independent clinical and dipstick predictors of infection and to develop clinical decision rules.
Design of study
Validation study of clinical and dipstick findings compared with laboratory testing.
Setting
General practices in the south of England.
Method
Laboratory diagnosis of 427 women with suspected UTI was assessed using European urinalysis guidelines. Independent clinical and dipstick predictors of diagnosis were estimated.
Results
UTI was confirmed in 62.5% of women with suspected UTI. Only nitrite, leucocyte esterase (+ or greater), and blood (haemolysed trace or greater) independently predicted diagnosis (adjusted odds ratios 6.36, 4.52, 2.23 respectively). A dipstick decision rule, based on having nitrite, or both leucocytes and blood, was moderately sensitive (77%) and specific (70%); positive predictive value (PPV) was 81% and negative predictive value (NPV) was 65%. Predictive values were improved by varying the cut-off point: NPV was 73% for all three dipstick results being negative, and PPV was 92% for having nitrite and either blood or leucocyte esterase. A clinical decision rule, based on having two of the following: urine cloudiness, offensive smell, and dysuria and/or nocturia of moderate severity, was less sensitive (65%) (specificity 69%; PPV 77%, NPV 54%). NPV was 71% for none of the four clinical features, and the PPV was 84% for three or more features.
Conclusions
Simple decision rules could improve targeting of investigation and treatment. Strategies to use such rules need to take into account limited negative predictive value, which is lower than expected from previous research.
PMCID: PMC1874525  PMID: 16882379
clinical scoring algorithms; diagnosis, urinary tract infection; dipsticks
10.  Consultations for middle ear disease, antibiotic prescribing and risk factors for reattendance: a case-linked cohort study 
Background
Otitis media is the most common reason for children to receive antibiotics, but there is no evidence about the effect of prescribing on reattendance.
Aim
To evaluate the changing workload of middle ear disease in general practice, and the impact on surgery reattendance of prescribing antibiotics at first attendance.
Design of study
A case-linked cohort analysis for antibiotic prescribing versus no prescribing at first consultation event.
Setting
Two hundred and ninety-one practices spread throughout the UK recording for the General Practice Research Database (GPRD) and incorporating individual patient data records for 2 265 574 patients.
Method
All middle ear disease coded events that can be classed within acute otitis media (AOM) or glue ear sub-categories (and excluding chronic suppurative otitis media) were selected for analysis when the first event was from 1991–2001. The effect of antibiotic prescription on the risk of reattendance using Cox proportional hazards regression was analysed.
Results
Total consultations for AOM have fallen markedly over this decade, and glue ear consultations have risen but by a much smaller extent (26 000 decrease versus 4000 increase in consultations per year), which makes re-labelling an unlikely explanation of the fall in AOM consultations. In the 2–10 years age range, consultations for AOM fell from 105.3 to 34.7 per 1000 per year, with glue ear consultations unaltered (15.2 to 16.7 per 1000 per year). Antibiotic prescribing for AOM has stayed remarkably constant (80–84% of consultations), but antibiotic prescribing for glue ear has risen sharply (13 to 62%). Prescribing antibiotics increased the risk of reattendance for AOM (hazard ratio [HR] = 1.09, 95% confidence interval [CI] = 1.07 to 1.10) and has reduced the risk of reattendance for glue ear (HR = 0.92, 95% CI = 0.88 to 0.96).
Conclusion
Prescribing antibiotics for AOM probably increased reattendance, but the opposite effect has been noted for glue ear, which suggests a treatment effect of antibiotics in glue ear. Further research is needed to clarify whether this possible benefit is worth the known harms, and if so in which subgroups of children.
PMCID: PMC1828259  PMID: 16536956
acute disease; antibiotics; case studies; cohort studies; otitis media with effusion; reattendance; risk factors
11.  Cost analysis of nurse telephone consultation in out of hours primary care: evidence from a randomised controlled trial 
BMJ : British Medical Journal  2000;320(7241):1053-1057.
Objective
To undertake an economic evaluation of nurse telephone consultation using decision support software in comparison with usual general practice care provided by a general practice cooperative.
Design
Cost analysis from an NHS perspective using stochastic data from a randomised controlled trial.
Setting
General practice cooperative with 55 general practitioners serving 97 000 registered patients in Wiltshire, England.
Subjects
All patients contacting the service, or about whom the service was contacted during the trial year (January 1997 to January 1998).
Main outcome measures
Costs and savings to the NHS during the trial year.
Results
The cost of providing nurse telephone consultation was £81 237 per annum. This, however, determined a £94 422 reduction of other costs for the NHS arising from reduced emergency admissions to hospital. Using point estimates for savings, the cost analysis, combined with the analysis of outcomes, showed a dominance situation for the intervention over general practice cooperative care alone. If a larger improvement in outcomes is assumed (upper 95% confidence limit) NHS savings increase to £123 824 per annum. Savings of only £3728 would, however, arise in a scenario where lower 95% confidence limits for outcome differences were observed. To break even, the intervention would have needed to save 138 emergency hospital admissions per year, around 90% of the effect achieved in the trial. Additional savings of £16 928 for general practice arose from reduced travel to visit patients at home and fewer surgery appointments within three days of a call.
Conclusions
Nurse telephone consultation in out of hours primary care may reduce NHS costs in the long term by reducing demand for emergency admission to hospital. General practitioners currently bear most of the cost of nurse telephone consultation and benefit least from the savings associated with it. This indicates that the service produces benefits in terms of service quality, which are beyond the reach of this cost analysis.
PMCID: PMC27349  PMID: 10764368
13.  Safety and effectiveness of nurse telephone consultation in out of hours primary care: randomised controlled trial 
BMJ : British Medical Journal  1998;317(7165):1054-1059.
Objective To determine the safety and effectiveness of nurse telephone consultation in out of hours primary care by investigating adverse events and the management of calls.
Design Block randomised controlled trial over a year of 156 matched pairs of days and weekends in 26 blocks. One of each matched pair was randomised to receive the intervention.
Setting One 55 member general practice cooperative serving 97 000 registered patients in Wiltshire.
Subjects All patients contacting the out of hours service or about whom contact was made during specified times over the trial year.
Intervention A nurse telephone consultation service integrated within a general practice cooperative. The out of hours period was 615 pm to 1115 pm from Monday to Friday, 1100 am to 1115 pm on Saturday, and 800 am to 1115 pm on Sunday. Experienced and specially trained nurses received, assessed, and managed calls from patients or their carers. Management options included telephone advice; referral to the general practitioner on duty (for telephone advice, an appointment at a primary care centre, or a home visit); referral to the emergency service or advice to attend accident and emergency. Calls were managed with the help of decision support software.
Main outcome measures Deaths within seven days of a contact with the out of hours service; emergency hospital admissions within 24 hours and within three days of contact; attendance at accident and emergency within three days of a contact; number and management of calls in each arm of the trial.
Results 14 492 calls were received during the specified times in the trial year (7308 in the control arm and 7184 in the intervention arm) concerning 10 134 patients (10.4% of the registered population). There were no substantial differences in the age and sex of patients in the intervention and control groups, though male patients were underrepresented overall. Reasons for calling the service were consistent with previous studies. Nurses managed 49.8% of calls during intervention periods without referral to a general practitioner. A 69% reduction in telephone advice from a general practitioner, together with a 38% reduction in patient attendance at primary care centres and a 23% reduction in home visits was observed during intervention periods. Statistical equivalence was observed in the number of deaths within seven days, in the number of emergency hospital admissions, and in the number of attendances at accident and emergency departments.
Conclusions Nurse telephone consultation produced substantial changes in call management, reducing overall workload of general practitioners by 50% while allowing callers faster access to health information and advice. It was not associated with an increase in the number of adverse events. This model of out of hours primary care is safe and effective.
Key messagesTelephone consultation is becoming an increasingly accepted approach to patient care and improves public access to medical information and adviceThis study found that nurse telephone consultation halved the number of cases dealt with by general practitioners and was at least as safe as existing out of hours servicesNurse telephone consultation not only replaced telephone advice given by a doctor but led to reductions in both home visits and surgery attendances out of hoursFurther testing is required of variants to the system used in this trial, including the selection and training of nurses and the decision support software usedThere are clear opportunities for and potential benefits from integrating existing out of hours services with NHS Direct
PMCID: PMC28690  PMID: 9774295
16.  Clinical and cost effectiveness of booklet based vestibular rehabilitation for chronic dizziness in primary care: single blind, parallel group, pragmatic, randomised controlled trial 
Objective To determine the clinical and cost effectiveness of booklet based vestibular rehabilitation with and without telephone support for chronic dizziness, compared with routine care.
Design Single blind, parallel group, pragmatic, randomised controlled trial.
Setting 35 general practices across southern England between October 2008 and January 2011.
Participants Patients aged 18 years or over with chronic dizziness (mean duration >five years) not attributable to non-vestibular causes (confirmed by general practitioner) and that could be aggravated by head movement (confirmed by patient).
Interventions Participants randomly allocated to receive routine medical care, booklet based vestibular rehabilitation only, or booklet based vestibular rehabilitation with telephone support. For the booklet approach, participants received self management booklets providing comprehensive advice on undertaking vestibular rehabilitation exercises at home daily for up to 12 weeks and using cognitive behavioural techniques to promote positive beliefs and treatment adherence. Participants receiving telephone support were offered up to three brief sessions of structured support from a vestibular therapist.
Main outcome measures Vertigo symptom scale-short form and total healthcare costs related to dizziness per quality adjusted life year (QALY).
Results Of 337 randomised participants, 276 (82%) completed all clinical measures at the primary endpoint, 12 weeks, and 263 (78%) at one year follow-up. We analysed clinical effectiveness by intention to treat, using analysis of covariance to compare groups after intervention, controlling for baseline symptom scores. At 12 weeks, scores on the vertigo symptom scale in the telephone support group did not differ significantly from those in the routine care group (adjusted mean difference −1.79 (95% confidence interval −3.69 tο 0.11), P=0.064). At one year, both intervention groups improved significantly relative to routine care (telephone support −2.52 (−4.52 to −0.51), P=0.014; booklet only −2.43 (−4.27 to −0.60), P=0.010). Analysis of cost effectiveness acceptability curves showed that both interventions were highly cost effective; at very low QALY values, the booklet only approach was most likely to be cost effective, but the approach with additional telephone support was most likely to be cost effective at QALY values more than £1200 (€1488; $1932). Using the booklet approach with telephone support, five (three to 12) patients would need to be treated for one patient to report subjective improvement at one year.
Conclusions Booklet based vestibular rehabilitation for chronic dizziness is a simple and cost effective means of improving patient reported outcomes in primary care.
Trial registration ClinicalTrials.gov NCT00732797.
doi:10.1136/bmj.e2237
PMCID: PMC3368486  PMID: 22674920
17.  The effect of early confirmation of hearing loss on the behaviour in middle childhood of children with bilateral hearing impairment 
Aim
To determine if the benefit of early confirmation of permanent childhood hearing impairment (PCHI) on children’s receptive language development is associated with fewer behavioural problems.
Method
Follow-up of a total population cohort of 120 children with PCHI of moderate or greater severity (≥40 decibels relative to hearing threshold level) (67 males, 53 females; mean age 7y 11mo, range 5y 5mo–11y 8mo) and 63 hearing children (37 males, 26 females; mean age 8y 1mo, range 6y 4mo–9y 10mo). The main outcome measures were the Strengths and Difficulties Questionnaire (SDQ) completed by teachers and parents and the Vineland Adaptive Behaviour Scales (VABS) which are completed on the basis of a parental interview.
Results
Children with PCHI had lower standard scores than hearing children on the Daily Living Skills (p=0.001) and the Socialisation (p=0.001) scales of the VABS. They had significantly higher Total Behaviour Problem scores on the parent-rated (p=0.002) and teacher-rated SDQ (p=0.03). Children for whom PCHI was confirmed by 9 months did not have significantly fewer problems on the behavioural measures than those confirmed after that age (p=0.635 and p=0.196).
Interpretation
Early confirmation has a beneficial effect on receptive language development but no significant impact in reducing behavioural problems in children with PCHI.
doi:10.1111/j.1469-8749.2010.03839.x
PMCID: PMC3763205  PMID: 21121905
18.  Clinical score and rapid antigen detection test to guide antibiotic use for sore throats: randomised controlled trial of PRISM (primary care streptococcal management) 
Objective To determine the effect of clinical scores that predict streptococcal infection or rapid streptococcal antigen detection tests compared with delayed antibiotic prescribing.
Design Open adaptive pragmatic parallel group randomised controlled trial.
Setting Primary care in United Kingdom.
Patients Patients aged ≥3 with acute sore throat.
Intervention An internet programme randomised patients to targeted antibiotic use according to: delayed antibiotics (the comparator group for analyses), clinical score, or antigen test used according to clinical score. During the trial a preliminary streptococcal score (score 1, n=1129) was replaced by a more consistent score (score 2, n=631; features: fever during previous 24 hours; purulence; attends rapidly (within three days after onset of symptoms); inflamed tonsils; no cough/coryza (acronym FeverPAIN).
Outcomes Symptom severity reported by patients on a 7 point Likert scale (mean severity of sore throat/difficulty swallowing for days two to four after the consultation (primary outcome)), duration of symptoms, use of antibiotics.
Results For score 1 there were no significant differences between groups. For score 2, symptom severity was documented in 80% (168/207 (81%) in delayed antibiotics group; 168/211 (80%) in clinical score group; 166/213 (78%) in antigen test group). Reported severity of symptoms was lower in the clinical score group (−0.33, 95% confidence interval −0.64 to −0.02; P=0.04), equivalent to one in three rating sore throat a slight versus moderate problem, with a similar reduction for the antigen test group (−0.30, −0.61 to −0.00; P=0.05). Symptoms rated moderately bad or worse resolved significantly faster in the clinical score group (hazard ratio 1.30, 95% confidence interval 1.03 to 1.63) but not the antigen test group (1.11, 0.88 to 1.40). In the delayed antibiotics group, 75/164 (46%) used antibiotics. Use of antibiotics in the clinical score group (60/161) was 29% lower (adjusted risk ratio 0.71, 95% confidence interval 0.50 to 0.95; P=0.02) and in the antigen test group (58/164) was 27% lower (0.73, 0.52 to 0.98; P=0.03). There were no significant differences in complications or reconsultations.
Conclusion Targeted use of antibiotics for acute sore throat with a clinical score improves reported symptoms and reduces antibiotic use. Antigen tests used according to a clinical score provide similar benefits but with no clear advantages over a clinical score alone.
Trial registration ISRCTN32027234
doi:10.1136/bmj.f5806
PMCID: PMC3805475  PMID: 24114306
19.  Ibuprofen, paracetamol, and steam for patients with respiratory tract infections in primary care: pragmatic randomised factorial trial 
Objective To assess strategies for advice on analgesia and steam inhalation for respiratory tract infections.
Design Open pragmatic parallel group factorial randomised controlled trial.
Setting Primary care in United Kingdom.
Participants Patients aged ≥3 with acute respiratory tract infections.
Intervention 889 patients were randomised with computer generated random numbers in pre-prepared sealed numbered envelopes to components of advice or comparator advice: advice on analgesia (take paracetamol, ibuprofen, or both), dosing of analgesia (take as required v regularly), and steam inhalation (no inhalation v steam inhalation).
Outcomes Primary: mean symptom severity on days 2-4; symptoms rated 0 (no problem) to 7 (as bad as it can be). Secondary: temperature, antibiotic use, reconsultations.
Results Neither advice on dosing nor on steam inhalation was significantly associated with changes in outcomes. Compared with paracetamol, symptom severity was little different with ibuprofen (adjusted difference 0.04, 95% confidence interval −0.11 to 0.19) or the combination of ibuprofen and paracetamol (0.11, −0.04 to 0.26). There was no evidence for selective benefit with ibuprofen among most subgroups defined before analysis (presence of otalgia; previous duration of symptoms; temperature >37.5°C; severe symptoms), but there was evidence of reduced symptoms severity benefit in the subgroup with chest infections (ibuprofen −0.40, −0.78 to −0.01; combination −0.47; −0.84 to −0.10), equivalent to almost one in two symptoms rated as a slight rather than a moderately bad problem. Children might also benefit from treatment with ibuprofen (ibuprofen: −0.47, −0.76 to −0.18; combination: −0.04, −0.31 to 0.23). Reconsultations with new/unresolved symptoms or complications were documented in 12% of those advised to take paracetamol, 20% of those advised to take ibuprofen (adjusted risk ratio 1.67, 1.12 to 2.38), and 17% of those advised to take the combination (1.49, 0.98 to 2.18). Mild thermal injury with steam was documented for four patients (2%) who returned full diaries, but no reconsultations with scalding were documented.
Conclusion Overall advice to use steam inhalation, or ibuprofen rather than paracetamol, does not help control symptoms in patients with acute respiratory tract infections and must be balanced against the possible progression of symptoms during the next month for a minority of patients. Advice to use ibuprofen might help short term control of symptoms in those with chest infections and in children.
Trial registration ISRCTN 38551726.
doi:10.1136/bmj.f6041
PMCID: PMC3808081  PMID: 24162940
20.  Predictors of suppurative complications for acute sore throat in primary care: prospective clinical cohort study 
Objective To document whether elements of a structured history and examination predict adverse outcome of acute sore throat.
Design Prospective clinical cohort.
Setting Primary care.
Participants 14 610 adults with acute sore throat (≤2 weeks’ duration).
Main outcome measures Common suppurative complications (quinsy or peritonsillar abscess, otitis media, sinusitis, impetigo or cellulitis) and reconsultation with new or unresolving symptoms within one month.
Results Complications were assessed reliably (inter-rater κ=0.95). 1.3% (177/13 445) of participants developed complications overall and 14.2% (1889/13 288) reconsulted with new or unresolving symptoms. Independent predictors of complications were severe tonsillar inflammation (documented among 13.0% (1652/12 717); odds ratio 1.92, 95% confidence interval 1.28 to 2.89) and severe earache (5% (667/13 323); 3.02, 1.91 to 4.76), but the model including both variables had modest prognostic utility (bootstrapped area under the receiver operator curve 0.61, 0.57 to 0.65), and 70% of complications (124/177) occurred when neither was present. Clinical prediction rules for bacterial infection (Centor criteria and FeverPAIN) also predicted complications, but predictive values were also poor and most complications occurred with low scores (67% (118/175) scoring ≤2 for Centor; 126/173 (73%) scoring ≤2 for FeverPAIN). Previous medical problems, sex, temperature, and muscle aches were independently but weakly associated with reconsultation with new or unresolving symptoms.
Conclusion Important suppurative complications after an episode of acute sore throat in primary care are uncommon. History and examination and scores to predict bacterial infection cannot usefully identify those who will develop complications. Clinicians will need to rely on strategies such as safety netting or delayed prescription in managing the uncertainty and low risk of complications.
doi:10.1136/bmj.f6867
PMCID: PMC3898431  PMID: 24277339
21.  Delayed antibiotic prescribing strategies for respiratory tract infections in primary care: pragmatic, factorial, randomised controlled trial 
Objective To estimate the effectiveness of different strategies involving delayed antibiotic prescription for acute respiratory tract infections.
Design Open, pragmatic, parallel group, factorial, randomised controlled trial.
Setting Primary care in the United Kingdom.
Patients 889 patients aged 3 years and over with acute respiratory tract infection, recruited between 3 March 2010 and 28 March 2012 by 53 health professionals in 25 practices.
Interventions Patients judged not to need immediate antibiotics were randomised to undergo four strategies of delayed prescription: recontact for a prescription, post-dated prescription, collection of the prescription, and be given the prescription (patient led). During the trial, a strategy of no antibiotic prescription was added as another randomised comparison. Analysis was intention to treat.
Main outcome measures Mean symptom severity (0-6 scale) at days 2-4 (primary outcome), antibiotic use, and patients’ beliefs in the effectiveness of antibiotic use. Secondary analysis included comparison with immediate use of antibiotics.
Results Mean symptom severity had minimal differences between the strategies involving no prescription and delayed prescription (recontact, post-date, collection, patient led; 1.62, 1.60, 1.82, 1.68, 1.75, respectively; likelihood ratio test χ2 2.61, P=0.625). Duration of symptoms rated moderately bad or worse also did not differ between no prescription and delayed prescription strategies combined (median 3 days v 4 days; 4.29, P=0.368). There were modest and non-significant differences in patients very satisfied with the consultation between the randomised groups (79%, 74%, 80%, 88%, 89%, respectively; likelihood ratio test χ2 2.38, P=0.667), belief in antibiotics (71%, 74%, 73%, 72%, 66%; 1.62, P=0.805), or antibiotic use (26%, 37%, 37%, 33%, 39%; 4.96, P=0.292). By contrast, most patients given immediate antibiotics used antibiotics (97%) and strongly believed in them (93%), but with no benefit for symptom severity (score 1.76) or duration (median 4 days).
Conclusion Strategies of no prescription or delayed antibiotic prescription result in fewer than 40% of patients using antibiotics, and are associated with less strong beliefs in antibiotics, and similar symptomatic outcomes to immediate prescription. If clear advice is given to patients, there is probably little to choose between the different strategies of delayed prescription.
Trial registration ISRCTN38551726.
doi:10.1136/bmj.g1606
PMCID: PMC3944682  PMID: 24603565

Results 1-21 (21)