Paul Little

Reattendance and complications in a randomised trial of prescribing strategies for sore throat: the medicalising effect of prescribing antibiotics.

Abstract Objective: To assess the medicalising effect of prescribing antibiotics for sore throat. Setting: 11 general practices in England. Design: Randomised trial of three approaches to sore throat: a 10 day prescription of antibiotics, no antibiotics, or a delayed prescription if the sore throat had not started to settle after three days. Patients: 716 patients aged 4 and over with sore throat and an abnormal physical sign: 84% had tonsillitis or pharyngitis. Outcome measures: Number and rate of patients making a first return with sore throat, pharyngitis, or tonsillitis. Early returns (within two weeks) and complications (otitis media, sinusitis, quinsy). Outcomes were documented in 675 subjects (94%). Results: Mean follow up time was similar (antibiotic group 1.07 years, other two groups 1.03 years). More of those initially prescribed antibiotics initially returned to the surgery with sore throat (38% v 27%, adjusted hazard ratio for return 1.39, 95% confidence interval 1.03 to 1.89). Antibiotics prescribed for sore throat during the previous year had an additional effect (hazard ratio 1.69, 1.20 to 2.37). Longer duration of illness (> 5 days) was associated with increased return within six weeks (hazard ratio 2.90, 1.70 to 4.92). Prior attendance with upper respiratory conditions was also associated with increased reattendance. There was no difference between groups in early return (13/238 (5.5%) v 27/437 (6%)), or complications (2/236 (0.8%) v3/434 (0.7%)). Conclusions: Complications and early return resulting from no or delayed prescribing of antibiotics for sore throat are rare. Both current and previous prescribing for sore throat increase reattendance. To avoid medicalising a self limiting illness doctors should avoid antibiotics or offer a delayed prescription for most patients with sore throat. Key messages Sore throat is one of the commonest presentations of upper respiratory illness in primary care and attendence is increasing Complications are rare with no, or delayed, antibiotic prescription Prescribing antibiotics increases reattendance for future episodes Unless patients are very ill general practitioners should consider exploring concerns, explain the natural history, and avoid or delay prescribing antibiotics

Diabetes risk score: towards earlier detection of Type 2 diabetes in general practice

Type 2 diabetes is common, costly and often goes unrecognised for many years. When patients are diagnosed, the majority exhibit associated tissue damage or established cardiovascular risk. Evidence is accumulating that earlier detection and management of diabetes and related metabolic abnormalities may be beneficial. We aimed to develop and evaluate a score based on routinely collected information to identify people at risk of having undetected diabetes.

Open randomised trial of prescribing strategies in managing sore throat

Abstract Objective: To assess three prescribing strategies for sore throat. Design: Randomised follow up study. Setting: 11 general practices in the South and West region. Subjects: 716 patients aged 4 years and over with sore throat and an abnormal physical sign in the throat; 84% had tonsillitis or pharyngitis. Patients were randomised to three groups: prescription for antibiotics for 10 days (group 1, 246 patients); no prescription (group 2, 230 patients); or prescription for antibiotics if symptoms were not starting to settle after three days (group 3; 238 patients). Main outcome measures: Duration of symptoms; satisfaction and compliance with and perceived efficacy of antibiotics; time off school or work. Outcomes were documented in 582 subjects (81%). Results: Median duration of antibiotic use differed significantly in the three groups (10 v 0 v 0 days, P<0.001); 69% of patients in group 3 did not use their prescription. The proportion of patients better by day 3 did not differ significantly (37% v 35% v 30%, P=0.28), nor did the duration of illness (median 4 v 5 v 5 days, P=0.39), days off work or school (median 2 v 2 v 1, P=0.13), or proportion of patients satisfied (96% v 90% v 93%, P=0.09), although group 1 had fewer days of fever (median 1 v 2 v 2 days, P=0.04). More patients in group 1 thought the antibiotics were effective (87% v 55% v 60%, P<0.001) and intended coming to the doctor in future attacks (79% v 54% v 57%, P<0.001). “Legitimation” of illness—to explain to work or school (60%) or family or friends (37%)–was an important reason for consultation. Patients who were more satisfied got better more quickly, and satisfaction related strongly to how well the doctor dealt with patients concerns. Conclusion: Prescribing antibiotics for sore throat only marginally affects the resolution of symptoms but enhances belief in antibiotics and intention to consult in future when compared with the acceptable strategies of no prescription or delayed prescription. Psychosocial factors are important in the decision to see a general practitioner and in predicting the duration of illness. Key messages Sore throat is one of the commonest presentations of upper respiratory illness to general practitioners, and attendance is increasing Prescribing antibiotics for sore throat does not reduce the extent and duration of symptoms Prescribing antibiotics enhances belief in antibiotics and intention to consult Legitimation of illness is an important reason for attending the doctor Satisfaction predicts duration of illness and closely relates to how well concerns are dealt with—unless patients are very ill, general practitioners should consider exploring concerns and should avoid or delay prescribing antibiotics

Telemonitoring and self-management in the control of hypertension (TASMINH2): a randomised controlled trial

BACKGROUND Control of blood pressure is a key component of cardiovascular disease prevention, but is difficult to achieve and until recently has been the sole preserve of health professionals. This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care. METHODS This randomised controlled trial was undertaken in 24 general practices in the UK. Patients aged 35-85 years were eligible for enrolment if they had blood pressure more than 140/90 mm Hg despite antihypertensive treatment and were willing to self-manage their hypertension. Participants were randomly assigned in a 1:1 ratio to self-management, consisting of self-monitoring of blood pressure and self-titration of antihypertensive drugs, combined with telemonitoring of home blood pressure measurements or to usual care. Randomisation was done by use of a central web-based system and was stratified by general practice with minimisation for sex, baseline systolic blood pressure, and presence or absence of diabetes or chronic kidney disease. Neither participants nor investigators were masked to group assignment. The primary endpoint was change in mean systolic blood pressure between baseline and each follow-up point (6 months and 12 months). All randomised patients who attended follow-up visits at 6 months and 12 months and had complete data for the primary outcome were included in the analysis, without imputation for missing data. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN17585681. FINDINGS 527 participants were randomly assigned to self-management (n=263) or control (n=264), of whom 480 (91%; self-management, n=234; control, n=246) were included in the primary analysis. Mean systolic blood pressure decreased by 12.9 mm Hg (95% CI 10.4-15.5) from baseline to 6 months in the self-management group and by 9.2 mm Hg (6.7-11.8) in the control group (difference between groups 3.7 mm Hg, 0.8-6.6; p=0.013). From baseline to 12 months, systolic blood pressure decreased by 17.6 mm Hg (14.9-20.3) in the self-management group and by 12.2 mm Hg (9.5-14.9) in the control group (difference between groups 5.4 mm Hg, 2.4-8.5; p=0.0004). Frequency of most side-effects did not differ between groups, apart from leg swelling (self-management, 74 patients [32%]; control, 55 patients [22%]; p=0.022). INTERPRETATION Self-management of hypertension in combination with telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care. FUNDING Department of Health Policy Research Programme, National Coordinating Centre for Research Capacity Development, and Midlands Research Practices Consortium.

Antibiotics for acute otitis media: a meta-analysis with individual patient data

BACKGROUND Individual trials to test effectiveness of antibiotics in children with acute otitis media have been too small for valid subgroup analyses. We aimed to identify subgroups of children who would and would not benefit more than others from treatment with antibiotics. METHODS We did a meta-analysis of data from six randomised trials of the effects of antibiotics in children with acute otitis media. Individual patient data from 1643 children aged from 6 months to 12 years were validated and re-analysed. We defined the primary outcome as an extended course of acute otitis media, consisting of pain, fever, or both at 3-7 days. FINDINGS Significant effect modifications were noted for otorrhoea, and for age and bilateral acute otitis media. In children younger than 2 years of age with bilateral acute otitis media, 55% of controls and 30% on antibiotics still had pain, fever, or both at 3-7 days, with a rate difference between these groups of -25% (95% CI -36% to -14%), resulting in a number-needed-to-treat (NNT) of four children. We identified no significant differences for age alone. In children with otorrhoea the rate difference and NNT, respectively, were -36% (-53% to -19%) and three, whereas in children without otorrhoea the equivalent values were -14% (-23% to -5%) and eight. INTERPRETATION Antibiotics seem to be most beneficial in children younger than 2 years of age with bilateral acute otitis media, and in children with both acute otitis media and otorrhoea. For most other children with mild disease an observational policy seems justified.

Variation in antibiotic prescribing and its impact on recovery in patients with acute cough in primary care: prospective study in 13 countries

Objective To describe variation in antibiotic prescribing for acute cough in contrasting European settings and the impact on recovery. Design Cross sectional observational study with clinicians from 14 primary care research networks in 13 European countries who recorded symptoms on presentation and management. Patients followed up for 28 days with patient diaries. Setting Primary care. Participants Adults with a new or worsening cough or clinical presentation suggestive of lower respiratory tract infection. Main outcome measures Prescribing of antibiotics by clinicians and total symptom severity scores over time. Results 3402 patients were recruited (clinicians completed a case report form for 99% (3368) of participants and 80% (2714) returned a symptom diary). Mean symptom severity scores at presentation ranged from 19 (scale range 0 to 100) in networks based in Spain and Italy to 38 in the network based in Sweden. Antibiotic prescribing by networks ranged from 20% to nearly 90% (53% overall), with wide variation in classes of antibiotics prescribed. Amoxicillin was overall the most common antibiotic prescribed, but this ranged from 3% of antibiotics prescribed in the Norwegian network to 83% in the English network. While fluoroquinolones were not prescribed at all in three networks, they were prescribed for 18% in the Milan network. After adjustment for clinical presentation and demographics, considerable differences remained in antibiotic prescribing, ranging from Norway (odds ratio 0.18, 95% confidence interval 0.11 to 0.30) to Slovakia (11.2, 6.20 to 20.27) compared with the overall mean (proportion prescribed: 0.53). The rate of recovery was similar for patients who were and were not prescribed antibiotics (coefficient −0.01, P<0.01) once clinical presentation was taken into account. Conclusions Variation in clinical presentation does not explain the considerable variation in antibiotic prescribing for acute cough in Europe. Variation in antibiotic prescribing is not associated with clinically important differences in recovery. Trial registration Clinicaltrials.gov NCT00353951.

Randomised controlled trial of Alexander Technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain

Objective To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain. Design Factorial randomised trial. Setting 64 general practices in England. Participants 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons, and 144 to 24 Alexander technique lessons; half of each of these groups were randomised to exercise prescription. Interventions Normal care (control), six sessions of massage, six or 24 lessons on the Alexander technique, and prescription for exercise from a doctor with nurse delivered behavioural counselling. Main outcome measures Roland Morris disability score (number of activities impaired by pain) and number of days in pain. Results Exercise and lessons in the Alexander technique, but not massage, remained effective at one year (compared with control Roland disability score 8.1: massage −0.58, 95% confidence interval −1.94 to 0.77, six lessons −1.40, −2.77 to −0.03, 24 lessons −3.4, −4.76 to −2.03, and exercise −1.29, −2.25 to −0.34). Exercise after six lessons achieved 72% of the effect of 24 lessons alone (Roland disability score −2.98 and −4.14, respectively). Number of days with back pain in the past four weeks was lower after lessons (compared with control median 21 days: 24 lessons −18, six lessons −10, massage −7) and quality of life improved significantly. No significant harms were reported. Conclusions One to one lessons in the Alexander technique from registered teachers have long term benefits for patients with chronic back pain. Six lessons followed by exercise prescription were nearly as effective as 24 lessons. Trial registration National Research Register N0028108728. How does the Alexander Technique work? What are the authors findings about the clinical and cost effectiveness of the treatment? Watch this video to find out (12 mins). 10.1136/bmj.a884V1

European Surveillance of Antimicrobial Consumption (ESAC): quality indicators for outpatient antibiotic use in Europe

Background and objective: Indicators to measure the quality of healthcare are increasingly used by healthcare professionals and policy makers. In the context of increasing antimicrobial resistance, this study aimed to develop valid drug-specific quality indicators for outpatient antibiotic use in Europe, derived from European Surveillance of Antimicrobial Consumption (ESAC) data. Methods: 27 experts (15 countries), in a European Science Foundation workshop, built on the expertise within the European Drug Utilisation Research Group, the General Practice Respiratory Infections Network, the ESCMID Study Group on Primary Care Topics, the Belgian Antibiotic Policy Coordination Committee, the World Health Organization, ESAC, and other experts. A set of proposed indicators was developed using 1997–2003 ESAC data. Participants scored the relevance of each indicator to reducing antimicrobial resistance, patient health benefit, cost effectiveness and public health policy makers (scale: 1 (completely disagree) to 9 (completely agree)). The scores were processed according to the UCLA-RAND appropriateness method. Indicators were judged relevant if the median score was not in the 1–6 interval and if there was consensus (number of scores within the 1–3 interval was fewer than one third of the panel). From the relevant indicators providing overlapping information, the one with the highest scores was selected for the final set of quality indicators—values were updated with 2004 ESAC data. Results: 22 participants (12 countries) completed scoring of a set of 22 proposed indicators. Nine were rated as relevant antibiotic prescribing indicators on all four dimensions; five were rated as relevant if only relevance to reducing antimicrobial resistance and public health policy makers was taken into account. A final set of 12 indicators was selected. Conclusion: 12 of the proposed ESAC-based quality indicators for outpatient antibiotic use in Europe have face validity and are potentially applicable. These indicators could be used to better describe antibiotic use in ambulatory care and assess the quality of national antibiotic prescribing patterns in Europe.

Effects of internet-based training on antibiotic prescribing rates for acute respiratory-tract infections: a multinational, cluster, randomised, factorial, controlled trial

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.

Design, analysis and presentation of factorial randomised controlled trials

BackgroundThe evaluation of more than one intervention in the same randomised controlled trial can be achieved using a parallel group design. However this requires increased sample size and can be inefficient, especially if there is also interest in considering combinations of the interventions. An alternative may be a factorial trial, where for two interventions participants are allocated to receive neither intervention, one or the other, or both. Factorial trials require special considerations, however, particularly at the design and analysis stages.DiscussionUsing a 2 × 2 factorial trial as an example, we present a number of issues that should be considered when planning a factorial trial. The main design issue is that of sample size. Factorial trials are most often powered to detect the main effects of interventions, since adequate power to detect plausible interactions requires greatly increased sample sizes. The main analytical issues relate to the investigation of main effects and the interaction between the interventions in appropriate regression models. Presentation of results should reflect the analytical strategy with an emphasis on the principal research questions. We also give an example of how baseline and follow-up data should be presented. Lastly, we discuss the implications of the design, analytical and presentational issues covered.SummaryDifficulties in interpreting the results of factorial trials if an influential interaction is observed is the cost of the potential for efficient, simultaneous consideration of two or more interventions. Factorial trials can in principle be designed to have adequate power to detect realistic interactions, and in any case they are the only design that allows such effects to be investigated.