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Objectives To measure the effect of the adverse events within 35 days of transrectal ultrasound guided biopsy from the perspective of asymptomatic men having prostate specific antigen (PSA) testing; to assess early attitude to re-biopsy; to estimate healthcare resource use associated with adverse events due to biopsy; and to develop a classification scheme for reporting adverse events after prostate biopsy. Design Prospective cohort study (Prostate Biopsy Effects: ProBE) nested within Prostate Testing for Cancer and Treatment (ProtecT) study. Participants Between 1999 and 2008, 227 000 community dwelling men aged 50­69 years were identified at 352 practices and invited to counselling about PSA testing. 111 148 attended a nurse led clinic in the community, and 10 297 with PSA concentrations of 3-20 ng/mL were offered biopsy within ProtecT. Between February 2006 and May 2008, 1147/1753 (65%) eligible men (mean age 62.1 years, mean PSA 5.4 ng/mL) having 10 core transrectal ultrasound guided biopsy under antibiotic cover in the context of ProtecT were recruited to the ProBE study. Outcome measures Purpose designed questionnaire administered at biopsy and 7 and 35 days after the procedure to measure frequency and effect of symptoms related to pain, infection, and bleeding; patients’ attitude to repeat biopsy assessed immediately after biopsy and 7 days later; participants’ healthcare resource use within 35 days of biopsy evaluated by questionnaire, telephone follow-up, and medical note review; each man’s adverse event profile graded according to symptoms and healthcare use. Results Pain was reported by 429/984 (43.6%), fever by 172/985 (17.5%), haematuria by 642/976 (65.8%), haematochezia by 356/967 (36.8%), and haemoejaculate by 605/653 (92.6%) men during the 35 days after biopsy. Fewer men rated these symptoms as a major/moderate problem—71/977 (7.3%) for pain, 54/981 (5.5%) for fever, 59/958 (6.2%) for haematuria, 24/951 (2.5%) for haematochezia, and 172/646 (26.6%) for haemoejaculate. Immediately after biopsy, 124/1142 (10.9%, 95% confidence interval 9.2 to 12.8) men reported that they would consider further biopsy a major or moderate problem: seven days after biopsy, this proportion had increased to 213/1085 (19.6%, 17.4% to 22.1%). A negative attitude to repeat biopsy was associated with unfavourable experience after the first biopsy, particularly pain at biopsy (odds ratio 8.2, P

Objective To assess the effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections. Design Open randomised controlled trial. Setting 11 general hospitals and two academic centres. Participants 111 children aged 1-6 with recurrent upper respiratory tract infections selected for adenoidectomy. Intervention A strategy of immediate adenoidectomy with or without myringotomy or a strategy of initial watchful waiting. Main outcome measure Primary outcome measure: number of upper respiratory tract infections per person year calculated from data obtained during the total follow-up (maximum 24 months). Secondary outcome measures: days with upper respiratory tract infection per person year, middle ear complaints with fever in episodes and days, days with fever, prevalence of upper respiratory tract infections, and health related quality of life. Results During the median follow-up of 24 months, there were 7.91 episodes of upper respiratory tract infections per person year in the adenoidectomy group and 7.84 in the watchful waiting group (difference in incidence rate 0.07, 95% confidence interval −0.70 to 0.85). No relevant differences were found for days of upper respiratory tract infections and middle ear complaints with fever in episodes and days, nor for health related quality of life. The prevalence of upper respiratory tract infections decreased over time in both groups. Children in the adenoidectomy group had significantly more days with fever than the children in the watchful waiting group. Two children had complications related to surgery. Conclusion In children selected for adenoidectomy for recurrent upper respiratory tract infections, a strategy of immediate surgery confers no clinical benefits over a strategy of initial watchful waiting. Trial registration Dutch Trial Register NTR968: ISRCTN03720485.

Objective To systematically review the risk of mortality associated with long term use of tiotropium delivered using a mist inhaler for symptomatic improvement in chronic obstructive pulmonary disease. Data sources Medline, Embase, the pharmaceutical company clinical trials register, the US Food and Drug Administration website, and ClinicalTrials.gov for randomised controlled trials from inception to July 2010. Study selection Trials were selected for inclusion if they were parallel group randomised controlled trials of tiotropium solution using a mist inhaler (Respimat Soft Mist Inhaler, Boehringer Ingelheim) versus placebo for chronic obstructive pulmonary disease; the treatment duration was more than 30 days, and they reported data on mortality. Relative risks of all cause mortality were estimated using a fixed effect meta-analysis, and heterogeneity was assessed with the I2 statistic. Results Five randomised controlled trials were eligible for inclusion. Tiotropium mist inhaler was associated with a significantly increased risk of mortality (90/3686 v 47/2836; relative risk 1.52, 95% confidence interval, 1.06 to 2.16; P=0.02; I2=0%). Both 10 µg (2.15, 1.03 to 4.51; P=0.04; I2=9%) and 5 µg (1.46, 1.01 to 2.10; P=0.04; I2=0%) doses of tiotropium mist inhaler were associated with an increased risk of mortality. The overall estimates were not substantially changed by sensitivity analysis of the fixed effect analysis of the five trials combined using the random effects model (1.45, 1.02 to 2.07; P=0.04), limiting the analysis to three trials of one year’s duration each (1.50, 1.05 to 2.15), or the inclusion of additional data on tiotropium mist inhaler from another investigational drug programme (1.42, 1.01 to 2.00). The number needed to treat for a year with the 5 µg dose to see one additional death was estimated to be 124 (95% confidence interval 52 to 5682) based on the average control event rate from the long term trials. Conclusions This meta-analysis explains safety concerns by regulatory agencies and indicates a 52% increased risk of mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease.

Objectives To evaluate the effectiveness of integrated motivational interviewing and cognitive behavioural therapy in addition to standard care for patients with psychosis and a comorbid substance use problem. Design Two centre, open, rater blind randomised controlled trial. Setting Secondary care in the United Kingdom. Participants 327 patients with a clinical diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder and a diagnosis of dependence on or misuse of drugs, alcohol, or both according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition. Intervention The intervention was integrated motivational interviewing and cognitive behavioural therapy plus standard care, which was compared with standard care alone. Phase one of therapy—“motivation building”—concerns engaging the patient, then exploring and resolving ambivalence for change in substance use. Phase two—“action”—supports and facilitates change using cognitive behavioural approaches. Up to 26 therapy sessions were delivered over one year. Main outcome measures The primary outcome was death from any cause or admission to hospital in the 12 months after completion of therapy. Secondary outcomes were frequency and amount of substance use (assessed using the timeline followback method), readiness to change, perceived negative consequences of use, psychotic symptom ratings, number and duration of relapses, and global assessment of functioning and deliberate self harm at 12 and 24 months, with additional timeline followback assessments at 6 and 18 months. Analysis was by intention to treat and robust treatment effect estimates were produced. Results 327 participants were randomly allocated to either the intervention (n=164) or treatment as usual (n=163). At 24 months, 326 (99.7%) were assessed on the primary outcome and 246 (75.2%) on the main secondary outcomes. Treatment had no beneficial effect on hospital admissions or death during follow-up, with 23.3% (38/163) of the therapy group and 20.2% (33/163) of controls deceased or admitted (adjusted odds ratio 1.16, 95% confidence interval 0.68 to 1.99; P=0.579). Therapy had no effect on the frequency of substance use or the perceived negative consequences of misuse, but did have a statistically significant effect on amount used per substance using day (adjusted ORs for main substance 1.50, 95% CI 1.08 to 2.09; P=0.016; and all substances 1.48, 95% CI 1.07 to 2.05; P=0.017). Treatment had a statistically significant effect on readiness to change use at 12 months (adjusted OR 2.05, 95% CI 1.26 to 3.31; P=0.004) that was not maintained at 24 months (0.78, 95% CI 0.48 to 1.28; P=0.320). There were no effects of treatment on clinical outcomes such as relapses, psychotic symptoms, functioning, and self harm. Conclusions Integrated motivational interviewing and cognitive behavioural therapy for people with psychosis and substance misuse do not improve outcome in terms of hospitalisation, symptom outcomes, or functioning. This approach does reduce the amount of substance used for at least one year after completion of therapy. Trial registration Current Controlled Trials: ISRCTN14404480.

Objective To determine whether a decision aid designed for adults with low education and literacy can support informed choice and involvement in decisions about screening for bowel cancer. Design Randomised controlled trial. Setting Areas in New South Wales, Australia identified as socioeconomically disadvantaged (low education attainment, high unemployment, and unskilled occupations). Participants 572 adults aged between 55 and 64 with low educational attainment, eligible for bowel cancer screening. Intervention Patient decision aid comprising a paper based interactive booklet (with and without a question prompt list) and a DVD, presenting quantitative risk information on the possible outcomes of screening using faecal occult blood testing compared with no testing. The control group received standard information developed for the Australian national bowel screening programme. All materials and a faecal occult blood test kit were posted directly to people’s homes. Main outcome measures Informed choice (adequate knowledge and consistency between attitudes and screening behaviour) and preferences for involvement in screening decisions. Results Participants who received the decision aid showed higher levels of knowledge than the controls; the mean score (maximum score 12) for the decision aid group was 6.50 (95% confidence interval 6.15 to 6.84) and for the control group was 4.10 (3.85 to 4.36; P

Objectives To compare standard high flow oxygen treatment with titrated oxygen treatment for patients with an acute exacerbation of chronic obstructive pulmonary disease in the prehospital setting. Design Cluster randomised controlled parallel group trial. Setting Ambulance service in Hobart, Tasmania, Australia. Participants 405 patients with a presumed acute exacerbation of chronic obstructive pulmonary disease who were treated by paramedics, transported, and admitted to the Royal Hobart Hospital during the trial period; 214 had a diagnosis of chronic obstructive pulmonary disease confirmed by lung function tests in the previous five years. Interventions High flow oxygen treatment compared with titrated oxygen treatment in the prehospital (ambulance/paramedic) setting. Main outcome measure Prehospital or in-hospital mortality. Results In an intention to treat analysis, the risk of death was significantly lower in the titrated oxygen arm compared with the high flow oxygen arm for all patients (high flow oxygen n=226; titrated oxygen n=179) and for the subgroup of patients with confirmed chronic obstructive pulmonary disease (high flow n=117; titrated n=97). Overall mortality was 9% (21 deaths) in the high flow oxygen arm compared with 4% (7 deaths) in the titrated oxygen arm; mortality in the subgroup with confirmed chronic obstructive pulmonary disease was 9% (11 deaths) in the high flow arm compared with 2% (2 deaths) in the titrated oxygen arm. Titrated oxygen treatment reduced mortality compared with high flow oxygen by 58% for all patients (relative risk 0.42, 95% confidence interval 0.20 to 0.89; P=0.02) and by 78% for the patients with confirmed chronic obstructive pulmonary disease (0.22, 0.05 to 0.91; P=0.04). Patients with chronic obstructive pulmonary disease who received titrated oxygen according to the protocol were significantly less likely to have respiratory acidosis (mean difference in pH 0.12 (SE 0.05); P=0.01; n=28) or hypercapnia (mean difference in arterial carbon dioxide pressure −33.6 (16.3) mm Hg; P=0.02; n=29) than were patients who received high flow oxygen. Conclusions Titrated oxygen treatment significantly reduced mortality, hypercapnia, and respiratory acidosis compared with high flow oxygen in acute exacerbations of chronic obstructive pulmonary disease. These results provide strong evidence to recommend the routine use of titrated oxygen treatment in patients with breathlessness and a history or clinical likelihood of chronic obstructive pulmonary disease in the prehospital setting. Trial registration Australian New Zealand Clinical Trials Register ACTRN12609000236291.

Objective To determine the extent to which intensive dietary intervention can influence glycaemic control and risk factors for cardiovascular disease in patients with type 2 diabetes who are hyperglycaemic despite optimised drug treatment. Design Randomised controlled trial. Setting Dunedin, New Zealand. Participants 93 participants aged less than 70 years with type 2 diabetes and a glycated haemoglobin (HbA1c) of more than 7% despite optimised drug treatments plus at least two of overweight or obesity, hypertension, and dyslipidaemia. Intervention Intensive individualised dietary advice (according to the nutritional recommendations of the European Association for the Study of Diabetes) for six months; both the intervention and control participants continued with their usual medical surveillance. Main outcome measures HbA1c was the primary outcome. Secondary outcomes included measures of adiposity, blood pressure, and lipid profile. Results After adjustment for age, sex, and baseline measurements, the difference in HbA1c between the intervention and control groups at six months (−0.4%, 95% confidence interval −0.7% to −0.1%) was highly statistically significant (P=0.007), as were the decreases in weight (−1.3 kg, −2.4 to −0.1 kg; P=0.032), body mass index (−0.5, −0.9 to −0.1; P=0.026), and waist circumference (−1.6 cm, −2.7 to −0.5 cm; P=0.005). A decrease in saturated fat (−1.9% total energy, −3.3% to −0.6%; P=0.006) and an increase in protein (1.6% total energy, 0.04% to 3.1%; P=0.045) in the intervention group were the most striking differences in nutritional intake between the two groups. Conclusions Intensive dietary advice has the potential to appreciably improve glycaemic control and anthropometric measures in patients with type 2 diabetes and unsatisfactory HbA1c despite optimised hypoglycaemic drug treatment. Trial registration Clinical trials NCT00124553.

Objective To assess the effects of the neuraminidase inhibitors oseltamivir and zanamivir in treatment of children with seasonal influenza and prevention of transmission to children in households. Design Systematic review and meta-analysis of data from published and unpublished randomised controlled trials. Data sources Medline and Embase to June 2009, trial registries, and manufacturers and authors of relevant studies. Review methods Eligible studies were randomised controlled trials of neuraminidase inhibitors in children aged ≤12 in the community (that is, not admitted to hospital) with confirmed or clinically suspected influenza. Primary outcome measures were time to resolution of illness and incidence of influenza in children living in households with index cases of influenza. Results We identified four randomised trials of treatment of influenza (two with oseltamivir, two with zanamivir) involving 1766 children (1243 with confirmed influenza, of whom 55-69% had influenza A), and three randomised trials for postexposure prophylaxis (one with oseltamivir, two with zanamivir) involving 863 children; none of these trials tested efficacy with the current pandemic strain. Treatment trials showed reductions in median time to resolution of symptoms or return to normal activities, or both, of 0.5-1.5 days, which were significant in only two trials. A 10 day course of postexposure prophylaxis with zanamivir or oseltamivir resulted in an 8% (95% confidence interval 5% to 12%) decrease in the incidence of symptomatic influenza. Based on only one trial, oseltamivir did not reduce asthma exacerbations or improve peak flow in children with asthma. Treatment was not associated with reduction in overall use of antibiotics (risk difference −0.30, −0.13 to 0.01). Zanamivir was well tolerated, but oseltamivir was associated with an increased risk of vomiting (0.05, 0.02 to 0.09, number needed to harm=20). Conclusions Neuraminidase inhibitors provide a small benefit by shortening the duration of illness in children with seasonal influenza and reducing household transmission. They have little effect on asthma exacerbations or the use of antibiotics. Their effects on the incidence of serious complications, and on the current A/H1N1 influenza strain remain to be determined.

Objectives To examine the effectiveness of cytological surveillance in primary care compared with immediate referral for colposcopic examination in women with low grade abnormal results on cervical cytology tests. Design Multicentre individually randomised controlled trial. Setting NHS cervical screening programmes in Grampian, Tayside, and Nottingham. Participants 4439 women, aged 20-59, with a cytology result showing borderline nuclear abnormalities or mild dyskaryosis, October 1999-October 2002. Interventions Cytological screening every six months in primary care (n=2223) or referral for colposcopy and related interventions (n=2216). All women were followed for three years, concluding with an exit appointment at which colposcopic examination was undertaken. Colposcopists assessing outcome at this appointment were blinded to randomisation. Main outcome measures Primary end point: cumulative incidence of cervical intraepithelial neoplasia grade II or more severe disease. Other end points: cervical intraepithelial neoplasia grade III or worse, clinically significant anxiety and depression, other self reported after effects, and rates of non-attendance. Analysis was by intention to treat; all those randomised were included. Results The cumulative incidence of cervical intraepithelial neoplasia grade II or worse was 79 per 1000 person years in the colposcopy arm and 58 per 1000 person years in the cytological surveillance arm (relative risk 1.37, 95% confidence interval 1.19 to 1.57). This difference was less marked for cervical intraepithelial neoplasia grade III or more severe disease, but the incidence was still higher in the colposcopy arm (relative risk 1.26, 1.04 to 1.53). Among women randomised to immediate colposcopy, 79% (74.9% to 82.5%) of cases of cervical intraepithelial neoplasia grade II or worse were diagnosed at the time of the immediate colposcopy, while among women randomised to cytological surveillance, 77% (72.1% to 81.2%) of cases were detected by surveillance cytology and related interventions. Similar proportions of women were anxious or depressed in the two arms. A higher proportion of women in the colposcopy arm reported after effects, and these were of longer duration and more severe. Non-attendance was low in both arms. Conclusion The more marked difference between the arms in the occurrence of cervical intraepithelial neoplasia grade II or worse than in the occurrence of grade III or worse can probably be accounted for by the spontaneous regression of some cases of grade II neoplasia. Compared with cytological surveillance, a policy of immediate colposcopy detects more cervical intraepithelial neoplasia grade II or worse, and some more grade III or worse, but might lead to overtreatment. Such a policy is associated with a higher rate of reported after effects, which are more severe and of longer duration than those associated with cytological surveillance. Trial registration ISRCTN 34841617.

Objective To evaluate the effectiveness of neuromuscular training in reducing the rate of acute knee injury in adolescent female football players. Design Stratified cluster randomised controlled trial with clubs as the unit of randomisation. Setting 230 Swedish football clubs (121 in the intervention group, 109 in the control group) were followed for one season (2009, seven months). Participants 4564 players aged 12-17 years (2479 in the intervention group, 2085 in the control group) completed the study. Intervention 15 minute neuromuscular warm-up programme (targeting core stability, balance, and proper knee alignment) to be carried out twice a week throughout the season. Main outcome measures The primary outcome was rate of anterior cruciate ligament injury; secondary outcomes were rates of severe knee injury (>4 weeks’ absence) and any acute knee injury. Results Seven players (0.28%) in the intervention group, and 14 (0.67%) in the control group had an anterior cruciate ligament injury. By Cox regression analysis according to intention to treat, a 64% reduction in the rate of anterior cruciate ligament injury was seen in the intervention group (rate ratio 0.36, 95% confidence interval 0.15 to 0.85). The absolute rate difference was −0.07 (95% confidence interval −0.13 to 0.001) per 1000 playing hours in favour of the intervention group. No significant rate reductions were seen for secondary outcomes. Conclusions A neuromuscular warm-up programme significantly reduced the rate of anterior cruciate ligament injury in adolescent female football players. However, the absolute rate difference did not reach statistical significance, possibly owing to the small number of events. Trial registration Clinical trials NCT00894595.

Objective To assess the impact of different management strategies in urinary tract infections. Design Randomised controlled trial. Setting Primary care. Participants 309 non-pregnant women aged 18-70 presenting with suspected urinary tract infection. Intervention Patients were randomised to five management approaches: empirical antibiotics; empirical delayed (by 48 hours) antibiotics; or targeted antibiotics based on a symptom score (two or more of urine cloudiness, urine smell, nocturia, or dysuria), a dipstick result (nitrite or both leucocytes and blood), or a positive result on midstream urine analysis. Self help advice was controlled in each group. Main outcome measures Symptom severity (days 2 to 4) and duration, and use of antibiotics. Results Patients had 3.5 days of moderately bad symptoms if they took antibiotics immediately. There were no significant differences in duration or severity of symptoms (mean frequency of symptoms on a 0 to 6 scale: immediate antibiotics 2.15, midstream urine 2.08, dipstick 1.74, symptom score 1.77, delayed antibiotics 2.11; likelihood ratio test for the five groups P=0.177). There were differences in antibiotic use (immediate antibiotics 97%, midstream urine 81%, dipstick 80%, symptom score 90%, delayed antibiotics 77%; P=0.011) and in sending midstream urine samples (immediate antibiotics 23%, midstream urine 89%, dipstick 36%, symptom score 33%, delayed antibiotics 15%; P

Summary of: Devoogdt N et al (2011) Effect of manual lymph drainage in addition to guidelines and exercise therapy on arm lymphoedema related to breast cancer: randomized controlled trial. BMJ 343: d5326. [Prepared by Nicholas Taylor, CAP Editor.] Question Does manual lymph drainage prevent lymphoedema in patients who have had surgery for breast cancer?. Design Randomised, controlled trial with concealed allocation and blinded outcome assessment. Setting A multidisciplinary breast centre of a tertiary hospital in Belgium. Participants Patients were eligible to be included if they received unilateral surgery with axillary node dissection for breast cancer, and agreed to participate. Randomisation of 160 participants allocated 79 to the intervention group and 81 to a control group. Interventions Both groups received guidelines about the prevention of lymphoedema in the form of a brochure, and exercise therapy involving supervised individualised 30 minute sessions - initially twice a week, reducing to once fortnightly as patients progressed. Participants in both groups were also asked to perform exercises at home twice/day. In addition, the intervention group received 40 sessions of manual lymph drainage over 20 weeks with each session lasting 30 minutes and performed by trained therapists. Outcome measures The primary outcomes were the cumulative incidence of and the time to develop arm lymphoedema (defined as a 200 ml increase) as measured with the water displacement method with measures taken at baseline and 1, 3, 6, and 12 months after surgery. Secondary outcome measures were lymphoedema measured with the arm circumference method, health-related quality of life using the SF-36 scale, and a patient reported questionnaire to score the presence of subjective arm lymphoedema. Results 154 participants (96%) completed the study at 12 months. At 12 months the incidence of lymphoedema in the intervention group (n=18, 24%) was similar to the incidence of lymphoedema in the control group (n = 15, 19%, OR 1.3, 95% CI 0.6 to 2.4); also there was no difference in incidence at 3 or 6 months. There was no difference between the groups in the time taken to develop lymphoedema, and no difference between the groups in any secondary outcome measure. Conclusion The application of manual lymph drainage after axillary node dissection for breast cancer in addition to providing guidelines and exercise therapy did not prevent lymphoedema in the first year after surgery.

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.

Objectives To determine whether observational studies that use an electronic medical record database can provide valid results of therapeutic effectiveness and to develop new methods to enhance validity. Design Data from the UK general practice research database (GPRD) were used to replicate previously performed randomised controlled trials, to the extent that was feasible aside from randomisation. Studies Six published randomised controlled trials. Main outcome measure Cardiovascular outcomes analysed by hazard ratios calculated with standard biostatistical methods and a new analytical technique, prior event rate ratio (PERR) adjustment. Results In nine of 17 outcome comparisons, there were no significant differences between results of randomised controlled trials and database studies analysed using standard biostatistical methods or PERR analysis. In eight comparisons, Cox adjusted hazard ratios in the database differed significantly from the results of the randomised controlled trials, suggesting unmeasured confounding. In seven of these eight, PERR adjusted hazard ratios differed significantly from Cox adjusted hazard ratios, whereas in five they didn’t differ significantly, and in three were more similar to the hazard ratio from the randomised controlled trial, yielding PERR results more similar to the randomised controlled trial than Cox (P

Question Does a program of quadriceps exercises or dietary advice, or both, reduce knee pain and improve knee function in people living in the community with knee pain? Design Factorial, randomised, controlled trial. Setting Five general practices in the United Kingdom with interventions delivered through home visits. Participants Community dwellers aged at least 45 years, who were overweight or obese (BMI ≥ 28) and complained of knee pain on most days of the past month. Randomisation of 389 participants allotted 82 to the quadriceps exercise group, 122 to the dietary advice group, 109 to the quadriceps exercise and dietary advice group, and 76 to a control group. Interventions The exercise groups were taught the exercises at home by a dietitian and received up to 6 further home visits over 24 months. Exercise participants were asked to complete ≥ 2 exercises a day, with 5 to 20 repetitions of each exercise. The exercises progressed from quadriceps setting exercises, to exercises with elasticised bands, to functional activities such as stepping up and down off a step. The dietary groups received individualised advice to reduce weight, newsletters with recipe ideas, and one home visit per month over 24 months. The control group received an advice leaflet. Outcome measures The primary outcome was pain reduction by ≥ 30% on the pain subscale of the Western Ontario McMaster (WOMAC) osteoarthritis index at 24 months. Secondary outcome measures were change in the WOMAC pain, stiffness, and physical function subscales, hospital anxiety and depression rating scale, and the bodily pain and physical function domains of the Short Form 36 (SF-36). Results 289 (74%) participants completed the study. At 24 months, those in the exercise groups were more likely to experience > 30% reduction in pain compared to the non-exercise groups (relative risk 1.36, 95% CI 1.05 to 1.76) with number needed to treat of 9 (95% CI 5 to 55). Compared to the non-exercise groups the exercise groups showed improvement in WOMAC physical function of −3.64 units (95% −6.01 to −1.27), WOMAC stiffness (−0.35 units, 95% CI −0.66 to −0.03), and improvements in the SF-36 subscales of bodily pain and physical function. The dietary advice groups lost weight (2.95 kg, 95% CI 1.44 to 4.46 kg) and reduced depression at 24 months compared to the non-dietary groups, but showed no evidence of an effect on any other outcomes. Conclusion A 2-year homebased quadriceps exercise program reduced knee pain and increased knee function in overweight and obese people with knee pain. The effect size was moderate. Dietary advice resulted in a modest weight loss that did not change pain or function, but did reduce depression.

Objective To assess the effectiveness of supervised exercise therapy compared with usual care with respect to recovery, pain, and function in patients with patellofemoral pain syndrome. Design Open label randomised controlled trial. Setting General practice and sport physician practice. Participants Patients with a new episode of patellofemoral pain syndrome recruited by their general practitioner or sport physician. Interventions The intervention group received a standardised exercise programme for 6 weeks tailored to individual performance and supervised by a physical therapist, and were instructed to practise the tailored exercises at home for 3 months. The control group were assigned usual care, which comprised a “wait and see” approach of rest during periods of pain and refraining from pain provoking activities. Both the intervention group and the control group received written information about patellofemoral pain syndrome and general instructions for home exercises. Main outcome measures The primary outcomes were self reported recovery (7 point Likert scale), pain at rest and pain on activity (0-10 point numerical rating scale), and function (0-100 point Kujala patellofemoral score) at 3 months and 12 months follow-up. Results A total of 131 participants were included in the study: 65 in the intervention group and 66 in the control group. After 3 months, the intervention group showed better outcomes than the control group with regard to pain at rest (adjusted difference −1.07, 95% confidence interval −1.92 to −0.22; effect size 0.47), pain on activity (−1.00, −1.91 to −0.08; 0.45), and function (4.92, 0.14 to 9.72; 0.34). At 12 months, the intervention group continued to show better outcomes than the control group with regard to pain (adjusted difference in pain at rest −1.29, −2.16 to −0.42; effect size 0.56; pain on activity −1.19, −2.22 to −0.16; effect size 0.54), but not function (4.52, −0.73 to 9.76). A higher proportion of patients in the exercise group than in the control group reported recovery (41.9% v 35.0% at 3 months and 62.1% v 50.8% at 12 months), although the differences in self reported recovery between the two groups were not statistically significant. Predefined subgroup analyses revealed that patients recruited by sport physicians (n=30) did not benefit from the intervention, whereas those recruited by general practitioners (n=101) showed significant and clinically relevant differences in pain and function in favour of the intervention group. Conclusion Supervised exercise therapy resulted in less pain and better function at short term and long term follow-up compared with usual care in patients with patellofemoral pain syndrome in general practice. Exercise therapy did not produce a significant difference in the rate of self reported recovery. Trial registration ISRCTN83938749.

Question Does a home-based proprioceptive exercise program reduce the one-year incidence of recurrent lateral ankle sprain in athletes? Design Randomised controlled trial. Setting Participants were recruited through primary care clinics as well as through advertisements in magazines, on the internet, and at sports tournaments in The Netherlands. Participants 522 athletes aged 12–70 years with a lateral ankle sprain in the preceding 2 months were allocated to one of two groups, using concealed allocation. The groups were comparable at baseline with respect to age, sex, hours of sports exposure, and history of ankle sprains. Interventions Athletes in both groups were free to seek and use any treatment they chose for their original ankle sprain. When any such interventions were complete and the athlete had returned to sport, only the intervention group additionally received an 8-week, unsupervised home-based proprioceptive training program, designed by physiotherapists. The program consisted of 3 sessions per week of up to 30 minutes each. An instructional DVD, exercise sheets, balance board, and web-based resources were provided to the intervention group. Exercises were gradually increased in difficulty and training load during the 8-week program. Outcomes The primary outcome was incidence of ankle sprain in the 1-year follow-up period, reported monthly on a web-based questionnaire. Reported ankle injury data were rated by a blinded assessor as acute ankle sprains or other ankle injuries. Participants who reported an ankle injury also completed a cost diary to record costs of healthcare and lost productivity until recovery. Results 86% of participants were followed up at 12 months. 33% of athletes in the control group reported an ankle sprain during follow-up, compared with 22% in the intervention group, which is an absolute risk reduction of 12% (95% CI 4 to 19) and number needed to treat of 9 (95% CI 26 to 5). Ankle sprains were further classified as those leading to loss of sports time, and those leading to costs of healthcare or lost productivity. Regardless of the classification used, significant reductions in the risk of ankle sprain were still evident after adjustment for age, type of sport, and level of sport. Conclusion A home-based proprioceptive training program for athletes reduces the risk of ankle re-sprain in the following year, particularly for those who do not seek other treatment.