Objective. To evaluate the long-term clinical effectiveness of a novel group-based outpatient physical therapy (PT) following total knee replacement (TKR).Methods. In this 2-center, unblinded, superiority, randomized controlled trial, 180 patients on a waiting list for primary TKR due to osteoarthritis were randomized to a 6 session group-based outpatient PT intervention and usual care (n = 89) or usual care alone (n = 91). The primary outcome was patient-reported functional ability measured by the Lower Extremity Functional Scale at 12 months postoperative. Secondary outcomes included knee symptoms, depression, anxiety, and satisfaction. Questionnaires were completed preoperatively and at 3, 6, and 12 months postoperatively.Results. The mean difference in function between groups was 4.47 (95% confidence interval [95% CI] 0.20, 8.75; P = 0.04) at 12 months postoperative, favoring the intervention. The mean difference in function between groups decreased over time, from 8.1 points at 3 months (95% CI 3.8, 12.4; P < 0.001) to 5.4 (95% CI 1.1, 9.8; P = 0.015) at 6 months postoperative. There were no clinically relevant differences in any secondary outcomes between groups, although patients in the intervention group were more likely to be satisfied with their PT. No serious adverse events related to the intervention were reported.Conclusion. Supplementing usual care with this group-based outpatient PT intervention led to improvements in function at 12 months after TKR, although the magnitude of the difference was below the minimum clinically important difference of 9 points. However, patient satisfaction was higher in the intervention group, and there was some evidence of clinically relevant improvements in function at 3 months.

BackgroundChronic obstructive pulmonary disease (COPD) accounts for 10% of emergency hospital admissions in the UK annually. Nearly 33% of patients are readmitted within 28 days of discharge. We evaluated the effectiveness of implementing standardised packages of care called ‘care bundles’ on COPD readmission, emergency department (ED) attendance, mortality, costs and process of care.MethodsThis is a mixed-methods, controlled before-and-after study with nested case studies. 31 acute hospitals in England and Wales which introduced COPD care bundles (implementation sites) or provided usual care (comparator sites) were recruited and provided monthly aggregate data. 14 sites provided additional individual patient data. Participants were adults admitted with an acute exacerbation of COPD.ResultsThere was no evidence that care bundles reduced 28-day COPD readmission rates: OR=1.02 (95% CI 0.83 to 1.26). However, the rate of ED attendance was reduced in implementation sites over and above that in comparator sites (implementation: IRR=0.63 (95% CI 0.56 to 0.71); comparator: IRR=1.12 (95% CI 1.02 to 1.24); group–time interaction p<0.001). At implementation sites, delivery of all bundle elements was higher but was only achieved in 2.2% (admissions bundle) and 7.6% (discharge bundle) of cases. There was no evidence of cost-effectiveness. Staff viewed bundles positively, believing they help standardise practice and facilitate communication between clinicians. However, they lacked skills in change management, leading to inconsistent implementation.DiscussionCOPD care bundles were not effectively implemented in this study. They were associated with a reduced number of subsequent ED attendances, but not with change in readmissions, mortality or reduced costs. This is unsurprising given the low level of bundle uptake in implementation sites, and it remains to be determined if COPD care bundles affect patient care and outcomes when they are effectively implemented.Trial registration numberISRCTN13022442.

BackgroundSafety-netting advice is information shared with a patient or their carer designed to help them identify the need to seek further medical help if their condition fails to improve, changes, or if they have concerns about their health.AimTo assess when and how safety-netting advice is delivered in routine GP consultations.Design and settingThis was an observational study using 318 recorded GP consultations with adult patients in the UK.MethodA safety-netting coding tool was applied to all consultations. Logistic regression for the presence or absence of safety-netting advice was compared between patient, clinician, and problem variables.ResultsA total of 390 episodes of safety-netting advice were observed in 205/318 (64.5%) consultations for 257/555 (46.3%) problems. Most advice was initiated by the GP (94.9%) and delivered in the treatment planning (52.1%) or closing (31.5%) consultation phases. Specific advice was delivered in almost half (47.2%) of episodes. Safety-netting advice was more likely to be present for problems that were acute (odds ratio [OR] 2.18, 95% confidence interval [CI] = 1.30 to 3.64), assessed first in the consultation (OR 2.94, 95% CI = 1.85 to 4.68) or assessed by GPs aged ≤49 years (OR 2.56, 95% CI = 1.45 to 4.51). Safety-netting advice was documented for only 109/242 (45.0%) problems.ConclusionGPs appear to commonly give safety-netting advice, but the contingencies or actions required on the patient’s part may not always be specific or documented. The likelihood of safety-netting advice being delivered may vary according to characteristics of the problem or the GP. How to assess safety-netting outcomes in terms of patient benefits and harms does warrant further exploration.

Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.