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.

BackgroundSkin complaints are common in primary care, and poor outcomes in long-term conditions are often due to low adherence to treatment. Shared decision making and self-management support may help, yet there is little understanding of patient involvement or the support provided by GPs.AimTo describe the content of primary care consultations for skin problems, including shared decision making practice, delivery of self-management advice, and follow-up.Design and settingCross-sectional study of video-recorded UK adult GP consultations and linked data.MethodA coding tool was developed and applied to all consultations with skin problems. Shared decision making was assessed using the observer OPTION5 scale.ResultsA total of 45/318 consultations (14.2%) related to one or more skin problems, which were discussed alongside other problems in 71.1% (32/45) of consultations. Of the 100 different problems discussed in these consultations, 51 were dermatological. The mean amount of time spent on skin problems in the consultations was 4 minutes 16 seconds. Medication was recommended for 66.7% (34/51) of skin problems, with low shared decision making (mean OPTION5 score = 10.7). Self-management advice (verbal only) was given for 47.1% (24/51) of skin problems. Most skin problems (84.3%; 43/51) were not referred to secondary care; 32.6% (14/43) of the skin problems not referred were seen again in primary care within 12 weeks, of which 35.7% (5/14) follow-up appointments were not planned.ConclusionIn this study, skin problems were usually presented alongside other complaints and resulted in a medication recommendation. Shared decision making was uncommon and self-management advice not consistently given, with re-attendance for the same problem common. GPs’ training should reflect how frequently skin problems are seen and seek to improve patient involvement in decision making and support self-management.

BackgroundFrequent attenders (FAs) to primary care receive considerable NHS resources without necessarily gaining benefit, and may even be harmed.AimTo assess the feasibility of a consultation-level intervention to improve care and address service use of FAs.Design & settingA cluster randomised controlled feasibility trial was undertaken. The study used a mixed-methods process evaluation and took place in six practices in England.MethodAll practices screened the top 3% of all attending patients over the previous 12 months for eligibility. Following randomisation, intervention patients were matched with named GPs, trained to use the Background, Affect, Trouble, Handling, Empathy (BATHE) technique during consultations. Telephone consultations were encouraged. Feasibility outcomes assessed were recruitment, retention, data collection and completeness, implementation fidelity, and acceptabilityResultsA total of 599/1328 (45.1%) FAs were eligible. Four practices were randomised to the intervention (n = 451) and two to usual care (n = 148). A total of 96 (23.7%) patients were recruited to complete questionnaires. Retention and completeness of data were good; for example, 76% of those agreeing to complete questionnaires did so at the 12-month assessment point. Thirty-four GPs were trained and delivered BATHE ≥1 times to 50.1% of patients (n = 577 consultations). There were minimal increases in continuity and telephone consultations. Patients were positive about the intervention, but noticed little change in their care. Despite valuing BATHE, low adherence to training was indicated and GPs used it less than anticipated.ConclusionIt was feasible to identify FAs and collect trial data. GPs were keen to engage and there was evidence that the BATHE technique was taken into practice. Optimising training is likely to improve fidelity. The intervention was low cost and low risk.

BackgroundApproximately 20% of patients experience chronic pain after total knee replacement. There is little evidence for effective interventions for the management of this pain, and current healthcare provision is patchy and inconsistent. Given the complexity of this condition, multimodal and individualised interventions matched to pain characteristics are needed. We have undertaken a comprehensive programme of work to develop a care pathway for patients with chronic pain after total knee replacement. This protocol describes the design of a randomised controlled trial to evaluate the clinical- and cost-effectiveness of a complex intervention care pathway compared with usual care.MethodsThis is a pragmatic two-armed, open, multi-centred randomised controlled trial conducted within secondary care in the UK. Patients will be screened at 2 months after total knee replacement and 381 patients with chronic pain at 3 months postoperatively will be recruited. Recruitment processes will be optimised through qualitative research during a 6-month internal pilot phase. Patients are randomised using a 2:1 intervention:control allocation ratio. All participants receive usual care as provided by their hospital. The intervention comprises an assessment clinic appointment at 3 months postoperatively with an Extended Scope Practitioner and up to six telephone follow-up calls over 12 months. In the assessment clinic, a standardised protocol is followed to identify potential underlying causes for the chronic pain and enable appropriate onward referrals to existing services for targeted and individualised treatment. Outcomes are assessed by questionnaires at 6 and 12 months after randomisation. The co-primary outcomes are pain severity and pain interference assessed using the Brief Pain Inventory at 12 months after randomisation. Secondary outcomes relate to resource use, function, neuropathic pain, mental well-being, use of pain medications, satisfaction with pain relief, pain frequency, capability, health-related quality of life and bodily pain. After trial completion, up to 30 patients in the intervention group will be interviewed about their experiences of the care pathway.DiscussionIf shown to be clinically and cost-effective, this care pathway intervention could improve the management of chronic pain after total knee replacement.Trial registrationISRCTN registry (ISRCTN92545361), prospectively registered on 30 August 2016.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2516-8) contains supplementary material, which is available to authorized users.

Background Chronic obstructive pulmonary disease (COPD) is the commonest respiratory disease in the UK, accounting for 10% of emergency hospital admissions annually. Nearly one-third of patients are re-admitted within 28 days of discharge. Objectives The study aimed to evaluate the effectiveness of introducing standardised packages of care (i.e. care bundles) as a means of improving hospital care and reducing re-admissions for COPD. Design A mixed-methods evaluation with a controlled before-and-after design. Participants Adults admitted to hospital with an acute exacerbation of COPD in England and Wales. Intervention COPD care bundles. Main outcome measures The primary outcome was re-admission to hospital within 28 days of discharge. The study investigated secondary outcomes including length of stay, total number of bed-days, in-hospital mortality, 90-day mortality, context, process and costs of care, and staff, patient and carer experience. Data sources Routine NHS data, including numbers of COPD admissions and re-admissions, in-hospital mortality and length of stay data, were provided by 31 sites for 12 months before and after the intervention roll-out. Detailed pseudo-anonymised data on care during admission were collected from a subset of 14 sites, in addition to information about delivery of individual components of care collected from random samples of medical records at each location. Six case study sites provided data from interviews, observation and documentary review to explore implementation, engagement and perceived impact on delivery of care. Results There is no evidence that care bundles reduced 28-day re-admission rates for COPD. All-cause re-admission rates, in-hospital mortality, length of stay, total number of bed-days, and re-admission and mortality rates in the 90 days following discharge were similar at implementation and comparator sites, as were resource utilisation, NHS secondary care costs and cost-effectiveness of care. However, the rate of emergency department (ED) attendances decreased more in implementation sites than in comparator sites {implementation: incidence rate ratio (IRR) 0.63 [95% confidence interval (CI) 0.56 to 0.70]; comparator: IRR 1.14 (95% CI 1.04 to 1.26) interaction p < 0.001}. Admission bundles appear to be more complex to implement than discharge bundles, with 3.7% of comparator patients receiving all five admission bundle elements, compared with 7.6% of patients in implementation sites, and 28.3% of patients in implementation sites receiving all five discharge bundle elements, compared with 0.8% of patients in the comparator sites. Although patients and carers were unaware that care was bundled, staff view bundles positively, as they help to standardise working practices, support a clear care pathway for patients, facilitate communication between clinicians and identify post-discharge support. Limitations The observational nature of the study design means that secular trends and residual confounding cannot be discounted as potential sources of any observed between-site differences. The availability of data from some sites was suboptimal. Conclusions Care bundles are valued by health-care professionals, but were challenging to implement and there was a blurring of the distinction between the implementation and comparator groups, which may have contributed to the lack of effect on re-admissions and mortality. Care bundles do appear to be associated with a reduced number of subsequent ED attendances, but care bundles are unlikely to be cost-effective for COPD. Future work A longitudinal study using implementation science methodology could provide more in-depth insights into the implementation of care bundles. Trial registration Current Controlled Trials ISRCTN13022442. Funding This project was funded by the National Institute for Health Research Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 7, No. 21. See the NIHR Journals Library website for further project information.