The clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomized controlled clinical trial.

OBJECTIVES: To investigate the clinical effectiveness, efficacy and cost effectiveness of splints (orthoses) in people with symptomatic basal thumb joint OA (BTOA). METHODS: A pragmatic, multicentre parallel group randomized controlled trial at 17 National Health Service (NHS) hospital departments recruited adults with symptomatic BTOA and at least moderate hand pain and dysfunction. We randomized participants (1:1:1) using a computer-based minimization system to one of three treatment groups: a therapist supported self-management programme (SSM), a therapist supported self-management programme plus a verum thumb splint (SSM+S), or a therapist supported self-management programme plus a placebo thumb splint (SSM+PS). Participants were blinded to group allocation, received 90 min therapy over 8 weeks and were followed up for 12 weeks from baseline. Australian/Canadian (AUSCAN) hand pain at 8 weeks was the primary outcome, using intention to treat analysis. We calculated costs of treatment. RESULTS: We randomized 349 participants to SSM (n = 116), SSM+S (n = 116) or SSM+PS (n = 117) and 292 (84%) provided AUSCAN Osteoarthritis Hand Index hand pain scores at the primary end point (8 weeks). All groups improved, with no mean treatment difference between groups: SSM+S vs SSM -0.5 (95% CI: -1.4, 0.4), P = 0.255; SSM+PS vs SSM -0.1 (95% CI: -1.0, 0.8), P = 0.829; and SSM+S vs SSM+PS -0.4 (95% CI: -1.4, 0.5), P = 0.378. The average 12-week costs were: SSM £586; SSM+S £738; and SSM+PS £685. CONCLUSION: There was no additional benefit of adding a thumb splint to a high-quality evidence-based, supported self-management programme for thumb OA delivered by therapists. TRIAL REGISTRATION: ISRCTN 54744256 (http://www.isrctn.com/ISRCTN54744256).

The Osteoarthritis Thumb Therapy (OTTER) II Trial: a study protocol for a three-arm multi-centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost-effectiveness of splints for symptomatic thumb base osteoarthritis.

INTRODUCTION: The economic cost of osteoarthritis (OA) is high. At least 4.4 million people have hand OA in the UK. Symptomatic thumb base OA affects 20% of people over 55 years, causing more pain, work and functional disability than OA elsewhere in the hand. Most evidence-based guidelines recommend splinting for hand OA. Splints that support or immobilise the thumb base are routinely used despite there being limited evidence on their effectiveness. The potential effects of placebo interventions in OA are acknowledged, but few studies investigate the clinical efficacy of rehabilitation interventions nor the impact of any placebo effects associated with splints. METHODS AND ANALYSIS: Participants aged 30 years and over with symptomatic thumb base OA will be recruited into the trial from secondary care occupational therapy and physiotherapy centres. Following informed consent, participants will complete a baseline questionnaire and then be randomised into one of three treatment arms: a self-management programme, a self-management programme plus a verum thumb splint or a self-management programme plus a placebo thumb splint. The primary outcome is the Australian Canadian Osteoarthritis Hand Index (AUSCAN) hand pain scale. The study endpoint is 8 weeks after baseline. Baseline assessments will be carried out prior to randomisation and outcomes collected at 4, 8 and 12 weeks. Cost-effectiveness analysis will be conducted and individual qualitative interviews conducted with up to 40 participants after 8 weeks to explore perceptions and outcome expectations of verum and placebo splints and exercise. ETHICS AND DISSEMINATION: South Central-Oxford C Research Ethics Committee approved this study (16/SC/0188). The findings will be disseminated to health professional conferences, journals and lay publications for patient organisations. The research will contribute to improving the management of thumb base OA and help clinicians and patients make informed decisions about the value of different interventions. TRIAL REGISTRATION NUMBER: ISRCTN54744256.

Influence of the duration of penicillin prescriptions on outcomes for acute sore throat in adults: the DESCARTE prospective cohort study in UK general practice.

BACKGROUND: Guidelines recommend 10-day treatment courses for acute sore throat, but shorter courses may be used in practice. AIM: To determine whether antibiotic duration predicts adverse outcome of acute sore throat in adults in routine care. DESIGN AND SETTING: A secondary analysis of the DESCARTE (Decision rule for the Symptoms and Complications of Acute Red Throat in Everyday practice) prospective cohort study of 12 829 adults presenting in UK general practice with acute sore throat. METHOD: A brief clinical proforma was used to collect symptom severity and examination findings at presentation. Outcomes were collected by notes review, a sample also completed a symptom diary. The primary outcome was re-consultation with new/non-resolving symptoms within 1 month. The secondary outcome was 'global' poorer symptom control (longer than the median duration or higher than median severity). RESULTS: Antibiotics were prescribed for 62% (7872/12 677) of participants. The most commonly prescribed antibiotic was phenoxymethylpenicillin (76%, 5656/7474) and prescription durations were largely for 5 (20%), 7 (57%), or 10 (22%) days. Compared with 5-day courses, those receiving longer courses were less likely to re-consult with new or non-resolving symptoms (5 days 15.3%, 7 days 13.9%, 10 days 12.2%, 7-day course adjusted risk ratio (RR) 0.92 [95% confidence interval [CI] = 0.76 to 1.11] and 10-days RR 0.86 [95% CI = 0.59 to 1.23]) but these differences did not reach statistical significance. CONCLUSION: In adults prescribed antibiotics for sore throat, the authors cannot rule out a small advantage in terms of reduced re-consultation for a 10-day course of penicillin, but the effect is likely to be small.

Symptom response to antibiotic prescribing strategies in acute sore throat in adults: the DESCARTE prospective cohort study in UK general practice.

BACKGROUND: A delayed or 'just in case' prescription has been identified as having potential to reduce antibiotic use in sore throat. AIM: To determine the symptomatic outcome of acute sore throat in adults according to antibiotic prescription strategy in routine care. DESIGN AND SETTING: A secondary analysis of the DESCARTE (Decision rule for the Symptoms and Complications of Acute Red Throat in Everyday practice) prospective cohort study comprising adults aged ≥16 years presenting with acute sore throat (≤2 weeks' duration) managed with treatment as usual in primary care in the UK. METHOD: A random sample of 2876 people from the full cohort were requested to complete a symptom diary. A brief clinical proforma was used to collect symptom severity and examination findings at presentation. Outcome details were collected by notes review and a detailed symptom diary. The primary outcome was poorer 'global' symptom control (defined as longer than the median duration or higher than median symptom severity). Analyses controlled for confounding by indication (propensity to prescribe antibiotics). RESULTS: A total of 1629/2876 (57%) of those requested returned a symptom diary, of whom 1512 had information on prescribing strategy. The proportion with poorer global symptom control was greater in those not prescribed antibiotics 398/587 (68%) compared with those prescribed immediate antibiotics 441/728 (61%) or delayed antibiotic prescription 116/197 59%); adjusted risk ratio (RR) (95% confidence intervals [CI]): immediate RR 0.87 (95% CI = 0.70 to 0.96), P = 0.006; delayed RR 0.88 (95% CI = 0.78 to 1.00), P = 0.042. CONCLUSION: In the routine care of adults with sore throat, a delayed antibiotic strategy confers similar symptomatic benefits to immediate antibiotics compared with no antibiotics. If a decision is made to prescribe an antibiotic, a delayed antibiotic strategy is likely to yield similar symptomatic benefit to immediate antibiotics.

Antibiotic prescription strategies for acute sore throat: a prospective observational cohort study.

BACKGROUND: Data from trials suggest that antibiotics reduce the risk of complications of sore throat by at least 50%, but few trials for complications have been done in modern settings, and datasets of delayed antibiotic prescription are underpowered. Observational evidence is important in view of poor compliance with antibiotic treatment outside trials, but no prospective observational cohort studies have been done to date. METHODS: We generated a large prospective cohort from the DESCARTE study, and the PRISM component of DESCARTE, of 12,829 adults presenting with sore throat (≤ 2 weeks duration) in primary care. Our follow-up of the cohort was based on a detailed and structured review of routine medical records, and analysis of the comparison of three antibiotic prescription strategies (no antibiotic prescription, immediate antibiotic prescription, and delayed antibiotic prescription) to control for the propensity to prescribe antibiotics. Information about antibiotic prescription was recorded in 12,677 individuals (4805 prescribed no antibiotics, 6088 prescribed antibiotics immediately, and 1784 prescribed delayed antibiotics). We documented by review of patients' notes (n=11,950) the development of suppurative complications (eg, quinsy, impetigo and cellulitis, otitis media, and sinusitis) or reconsultation with new or non-resolving symptoms). We used multivariate analysis to control for variables significantly related to the propensity to prescribe antibiotics and for clustering by general practitioner. FINDINGS: 164 (1.4%) of the 11,950 patients with information available developed complications; otitis media and sinusitis were the most common complications (101 patients [62%]). Compared with no antibiotic prescription, immediate antibiotic prescription was associated with fewer complications (adjusted risk ratio [RR] 0.62, 95% CI 0.43-0.91, estimated number needed to treat [NNT 193) as was delayed prescription of antibiotics (0.58, 0.34-0.98; NNT 174). 1787 of the 11,950 patients (15%) reconsulted with new or non-resolving symptoms; the risk of reconsultation was also reduced by immediate (0.83, 0.73-0.94; NNT 40) or delayed antibiotics (0.61, 0.50-0.74; NNT 18). INTERPRETATION: Suppurative complications are not common in primary care and most are not serious. The risks of suppurative complications or reconsultation in adults are reduced by antibiotics, but not as much as the trial evidence suggests. In most cases, no antibiotic is needed, but a delayed prescription strategy is likely to provide similar benefits to an immediate antibiotic prescription.

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.