A multi-centre randomised controlled trial evaluating exercise and manual therapy for osteoarthritis of the hip.

Exercise therapy (ET) is recommended in the management of hip OA, although the limited research to date shows small effects for reduction in pain and improvement of physical function. Manual therapy (MT), which comprises joint mobilisations and other hands-on techniques is commonly used by physiotherapists in Ireland as an adjunct to ET for hip OA but lacks evidence of efficacy. Therefore, this RCT (EMPART- Exercise and Manual Physiotherapy Arthritis Research Trial) was undertaken to primarily determine the clinical effectiveness of physiotherapy-based ET with and without MT for hip OA. A secondary aim was to ascertain the impact of an 8-week waiting period for physiotherapy on outcomes. A total of 131 people with hip OA recruited from four hospitals were initially randomised to one of three groups: ET (n=45), ETIMT (n=43) and wait-list control (n=43). Both intervention groups received treatment for 8 weeks, control group participants remained on the waiting list (8 weeks) and were subsequently randomised into the ET or ETIMT group. Their data were pooled with original treatment group data: ET (n=66) and ETIMT (n=65). All participants were assessed post-treatment (9 weeks) and at 18 weeks. The primary outcome was the WOMAC physical function (PF) subscale and secondary outcomes included physical performance tests, pain severity, hip range of motion (HROM), anxietyldepression, quality of life, pain medication usage, patient-perceived change and patient satisfaction. Ethical approval was obtained at all sites. Data were analysed according to intention-to-treat principles to determine between-group differences for the three groups at baseline and 9 weeks, and the two treatment groups at baseline, 9 and 18 weeks. Results for the primary study aim showed no significant difference in WOMAC PF between ET and ETIMT groups at 9 weeks (mean diff -0.91; 95%CI; -6.28, 4.44) and 18 weeks (mean diff -1.41; 95%CI; -7.12, 4.29) or other outcomes except \u27patient satisfaction with outcome\u27, which was greater for ETIMT group (p=0.02). Results for the three groups (secondary aim) showed significant improvement in WOMAC, HROM, pain severity and patient perceived improvement in the ET and ETIMT groups compared to the control group, with no significant difference between the three groups in the remaining outcomes. Qualitative interviews of a small sample of EMPART participants found that despite low patient expectations, results were positive for most patients in terms of predominantly physical outcomes. Questionnaire surveys of the EMPART physiotherapists established they generally viewed participation in EMPART as positive and they would continue to use the ET and MT protocols in clinical practice, with some modifications regarding frequency and duration of the interventions. Results indicate that MT has no further benefit as an adjunct to ET for hip OA, but patients can deteriorate in pain and function measures while waiting for physiotherapy. These findings have implications for clinicians who can use treatment time more efficiently and enhance selfmanagement principles for those with hip OA. It also has implications for those managing waiting lists to develop initiatives to minimise waiting times for those receiving physiotherapy

Clinical features of low back pain in people with hip osteoarthritis: A cross sectional study.

BACKGROUND: Low back pain (LBP) is commonly reported in people with hip osteoarthritis (OA) and is a poor prognostic indicator of outcome in OA. This study aimed to identify the clinical features associated with LBP in people with hip OA attending orthopaedic and rheumatology clinics. METHODS: A cross-sectional study was undertaken. Twenty-four people with radiographically confirmed OA were recruited and completed self-report questionnaires for hip and LBP severity (Visual Analogue Scale), hip-related disability (Western Ontario and McMaster Universities Osteoarthritis Index) and back-related disability (Roland Morris Disability Questionnaire). Physical examination comprised spinal palpation, pelvic girdle pain provocation tests and hip and spinal range of motion tests. Between-group (presence/absence of LBP) differences in self-report and physical examination items were compared using Mann-Whitney U and Chi-squared tests. RESULTS: A total of 16/24 (66.7%) patients reported LBP. Those with LBP were younger, reported more pain locations and had higher self-report pain and disability. On physical examination, people with LBP and OA hip had reduced hip flexion, greater pain provocation with hip abduction, hip lateral rotation, spinal palpation and a greater number of painful pelvic girdle tests and spinal level palpation. CONCLUSIONS: Assessment of patients with hip OA should incorporate examination of the lumbar spine and pelvic regions. It appears from our study that LBP is a common co-morbidity in those with OA of the hip and may indicate greater severity of hip disease, although the small sample size limits interpretation of results. Further research should investigate the exact relationships between presence of LBP and hip OA

Normalisation method can affect gluteus medius electromyography results during weight bearing exercises in people with hip osteoarthritis (OA): a case control study.

Surface electromyography (sEMG) is used to assess muscle activation during therapeutic exercise, but data are significantly affected by inter-individual variability and requires normalisation of the sEMG signal to enable comparison between individuals. The purpose of this study was to compare two normalisation methods, a maximal method (maximum voluntary isometric contraction (MVIC)) and non-maximal peak dynamic method (PDM), on gluteus medius (GMed) activation using sEMG during three weight-bearing exercises in people with hip osteoarthritis (OA) and healthy controls. Thirteen people with hip OA and 20 controls performed three exercises (Squat, Step-Up, Step-Down). Average root-mean squared EMG amplitude based on MVIC and PDM normalisation was compared between groups for both involved and uninvolved hips using Mann-Whitney tests. Using MVIC normalisation, significantly higher normalised GMed EMG amplitudes were found in the OA group during all Step-up and down exercises on the involved side (p=0.02-0.001) and most of the Step exercises on the uninvolved side (p=0.03-0.04), but not the Squat (p\u3e0.05), compared to controls. Using PDM normalisation, significant between-group differences occurred only for Ascending Squat (p=0.03) on the involved side. MVIC normalisation demonstrated higher inter-trial relative reliability (ICCs=0.78-0.99) than PDM (ICCs=0.37-0.84), but poorer absolute reliability using Standard Error of Measurement. Normalisation method can significantly affect interpretation of EMG amplitudes. Although MVIC-normalised amplitudes were more sensitive to differences between groups, there was greater variability using this method, which raises concerns regarding validity. Interpretation of EMG data is strongly influenced by the normalisation method used, and this should be considered when applying EMG results to clinical populations

Measuring patient satisfaction with exercise therapy for knee osteoarthritis: evaluating the utility of the physiotherapy outpatient survey.

OBJECTIVES: To assess patient satisfaction with exercise for knee osteoarthritis (OA). METHODS: A convenience sample of 27 patients recruited to a randomized controlled trial (RCT) comparing open kinetic chain and closed kinetic chain exercises for knee OA were reassessed at nine months post-randomization. Clinical outcomes included self-report and physical performance measures of function and pain severity. Patients also completed the Physiotherapy Outpatient Survey (POPS), which is a multi-dimensional measure of patient satisfaction with physiotherapy. RESULTS: There was no significant difference in satisfaction between the two intervention groups. Overall mean satisfaction for the entire cohort was 4.07 of a maximum score of 5 (standard deviation (SD) = 0.52). Lower levels of satisfaction with outcome (mean = 3.56, SD = 0.8) were reported compared with other domains of expectations, communication, organization and the therapist (mean = 3.79-4.49; SDs = 0.42-0.92). Both intervention groups improved from baseline on clinical outcomes of pain, self-report function and walking distance, with no significant differences between the two groups. CONCLUSIONS: High levels of satisfaction were reported in this subsample of knee OA patients participating in an RCT evaluating the effects of different exercise approaches for knee OA. Satisfaction varied depending on the satisfaction domain, with lower satisfaction with outcome compared with other aspects of care. The POPS questionnaire can be used to measure the multi-dimensional aspects of satisfaction with physiotherapy

ADvAnced PhysioTherapy in MuSculosKeletal Triage: Investigating prognostic factors, healthcare utilisation and clinical outcomes (ADAPT MSK) - a cohort study protocol. [version 1; peer review: 1 approved, 2 approved with reservations]

Background: Clinical specialist physiotherapist-led musculoskeletal triage clinics were introduced nationally in Ireland in 2011 to improve patient care and reduce waiting times for secondary care orthopaedics and rheumatology. Evidence has shown them to be effective in reducing waiting lists, however there are currently no data on longitudinal patient outcomes following clinic attendance. The primary aim of this cohort study is to identify predictors of pain and function outcomes up to one year following musculoskeletal triage review. Secondary aims include measuring self-reported use of healthcare resources over the 12-month follow-up period and to explore musculoskeletal phenotypes based on established prognostic factors for musculoskeletal pain. This is a prospective cohort study. Methods: ADvAnced PhysioTherapy in MuSculosKeletal Triage (ADAPT MSK) will recruit a cohort of 252 adults through musculoskeletal triage clinics across five secondary care sites in Ireland. The STrengthening the Reporting of Observational studies in Epidemiology (STROBE) guidelines will be adhered to for future reporting. Adults (≥ 18 years old) attending physiotherapist-led musculoskeletal triage clinics with musculoskeletal pain, who do not require surgical or consultant-led medical care will be considered for participation. Participant demographics, health literacy, healthcare utilisation, and self-report questionnaires on pain, function, musculoskeletal health, musculoskeletal risk stratification, fear of movement, and psychological distress will be obtained at baseline, with follow-ups at three, six, and 12 months. Primary outcomes are pain intensity and function. Secondary outcomes include musculoskeletal risk stratification status, musculoskeletal health, healthcare utilisation, and work-related factors. Descriptive statistics will be used to profile the participants and predictors of outcome will be assessed using multivariable linear regression. Musculoskeletal phenotypes will be explored using latent class analysis. Results: Results will be disseminated via peer-reviewed journal publication and presentation at national and international conferences. Engagement with a public patient involvement (PPI) panel will explore dissemination strategies for public and service user engagement

Engagement barriers and service inequities in the NHS Breast Screening Programme: Views from British-Pakistani women

Objectives: Previous research has largely attempted to explore breast screening experiences of South Asian women by combining opinions from Pakistani, Bangladeshi and Indian women. This research often fails to reach the most underserved sub-groups of this population, with socioeconomic status not routinely reported and English fluency being a participation requirement. With uptake low amongst British-Pakistani women, this study explores the experiences these women encounter when accessing the NHS Breast Screening Programme.Setting: Participants were from East Lancashire, UK. Methods: Nineteen one-to-one semi-structured interviews were carried out with British-Pakistani women. Fourteen interviews were conducted via an interpreter. Results: Data were analysed using thematic analysis. Three themes were identified: ‘Absence of autonomy in screening and healthcare access’ describes how currently the screening service does not facilitate confidentiality or independence. Access requires third-party intervention, with language barriers preventing self-expression. ‘Appraisal of information sources’ makes distinctions between community and NHS communication. Whereas community communication was invaluable, NHS materials were deemed inaccessible due to translation incongruences and incomprehensible terminology. ‘Personal suppositions of breast screening’ explores the subjective issues associated with disengagement, including, the cultural misalignment of the service and perceiving screening as a symptomatic service.Conclusions: British-Pakistani women face some unique challenges when accessing breast screening. To promote uptake, the service needs to address the translation of screening materials and optimise upon community networks to disseminate knowledge, including knowledge of the screening environment within the context of culture to promote informed choice about attendance

Are people with negative diabetes screening tests falsely reassured? Parallel group cohort study embedded in the ADDITION (Cambridge) randomised controlled trial

Objective To assess whether receiving a negative test result at primary care based stepwise diabetes screening results in false reassurance

Exercise and manual physiotherapy arthritis research trial (EMPART) for osteoarthritis of the hip: a multicenter randomized controlled trial.

OBJECTIVES: To determine the effectiveness of exercise therapy (ET) compared with ET with adjunctive manual therapy (MT) for people with hip osteoarthritis (OA); and to identify if immediate commencement of treatment (ET or ET+MT) was more beneficial than a 9-week waiting period for either intervention. DESIGN: Assessor-blind randomized controlled trial with a 9-week and 18-week follow-up. SETTING: Four academic teaching hospitals in Dublin, Ireland. PARTICIPANTS: Patients (N=131) with hip OA recruited from general practitioners, rheumatologists, orthopedic surgeons, and other hospital consultants were randomized to 1 of 3 groups: ET (n=45), ET+MT (n=43), and waitlist controls (n=43). INTERVENTIONS: Participants in both the ET and ET+MT groups received up to 8 treatments over 8 weeks. Control group participants were rerandomized into either ET or ET+MT groups after 9 week follow-up. Their data were pooled with original treatment group data: ET (n=66) and ET+MT (n=65). MAIN OUTCOME MEASURES: The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function (PF) subscale. Secondary outcomes included physical performance, pain severity, hip range of motion (ROM), anxiety/depression, quality of life, medication usage, patient-perceived change, and patient satisfaction. RESULTS: There was no significant difference in WOMAC PF between the ET (n=66) and ET+MT (n=65) groups at 9 weeks (mean difference, .09; 95% confidence interval [CI] -2.93 to 3.11) or 18 weeks (mean difference, .42; 95% CI, -4.41 to 5.25), or between other outcomes, except patient satisfaction with outcomes, which was higher in the ET+MT group (P=.02). Improvements in WOMAC, hip ROM, and patient-perceived change occurred in both treatment groups compared with the control group. CONCLUSIONS: Self-reported function, hip ROM, and patient-perceived improvement occurred after an 8-week program of ET for patients with OA of the hip. MT as an adjunct to exercise provided no further benefit, except for higher patient satisfaction with outcome

The introduction of risk stratified screening into the NHS breast screening Programme: views from British-Pakistani women

From Springer Nature via Jisc Publications RouterHistory: received 2019-12-16, accepted 2020-05-13, registration 2020-05-14, pub-electronic 2020-05-20, online 2020-05-20, collection 2020-12Publication status: PublishedFunder: NIHR Programme Grants for Applied Research (GB); Grant(s): RP-PG-1214-200016Funder: Manchester Biomedical Research Centre; doi: http://dx.doi.org/10.13039/100014653; Grant(s): IS-BRC-1215-20007Abstract: Background: UK national guidelines suggest women at high-risk of breast cancer should be offered more frequent screening or preventative medications. Currently, only 1 in 6 high-risk women are identified. One route to identify more high-risk women is via multifactorial risk assessment as part of the UK’s NHS Breast Screening Programme (NHSBSP). As lower socioeconomic and minority ethnic populations continue to experience barriers to screening, it is important that any new service does not exacerbate issues further. To inform service development, this study explored views of women from underserved backgrounds regarding the introduction of risk stratification into the NHSBSP. Methods: Nineteen semi-structured interviews were conducted with British-Pakistani women from low socioeconomic backgrounds from East Lancashire, UK. Fourteen interviews were conducted via an interpreter. Results: Thematic analysis produced three themes. Attitudes toward risk awareness concerns the positive views women have toward the idea of receiving personalised breast cancer risk information. Anticipated barriers to accessibility emphasises the difficulties associated with women’s limited English skills for accessing information, and their I.T proficiency for completing an online risk assessment questionnaire. Acceptability of risk communication strategy highlights the diversity of opinion regarding the suitability of receiving risk results via letter, with the option for support from a healthcare professional deemed essential. Conclusions: The idea of risk stratification was favourable amongst this underserved community. To avoid exacerbating inequities, this new service should provide information in multiple languages and modalities and offer women the opportunity to speak to a healthcare professional about risk. This service should also enable completion of personal risk information via paper questionnaires, as well as online

Cognitive behavioural therapy for clozapine-resistant schizophrenia: the FOCUS RCT

Background: Clozapine (clozaril, Mylan Products Ltd) is a first-choice treatment for people with schizophrenia who have a poor response to standard antipsychotic medication. However, a significant number of patients who trial clozapine have an inadequate response and experience persistent symptoms, called clozapine-resistant schizophrenia (CRS). There is little evidence regarding the clinical effectiveness of pharmacological or psychological interventions for this population. Objectives: To evaluate the clinical effectiveness and cost-effectiveness of cognitive–behavioural therapy (CBT) for people with CRS and to identify factors predicting outcome. Design: The Focusing on Clozapine Unresponsive Symptoms (FOCUS) trial was a parallel-group, randomised, outcome-blinded evaluation trial. Randomisation was undertaken using permuted blocks of random size via a web-based platform. Data were analysed on an intention-to-treat (ITT) basis, using random-effects regression adjusted for site, age, sex and baseline symptoms. Cost-effectiveness analyses were carried out to determine whether or not CBT was associated with a greater number of quality-adjusted life-years (QALYs) and higher costs than treatment as usual (TAU). Setting: Secondary care mental health services in five cities in the UK. Participants: People with CRS aged up to 16 years, with an International Classification of Diseases, Tenth Revision (ICD-10) schizophrenia spectrum diagnoses and who are experiencing psychotic symptoms. Interventions: Individual CBT included up to 30 hours of therapy delivered over 9 months. The comparator was TAU, which included care co-ordination from secondary care mental health services. Main outcome measures: The primary outcome was the Positive and Negative Syndrome Scale (PANSS) total score at 21 months and the primary secondary outcome was PANSS total score at the end of treatment (9 months post randomisation). The health benefit measure for the economic evaluation was the QALY, estimated from the EuroQol-5 Dimensions, five-level version (EQ-5D-5L), health status measure. Service use was measured to estimate costs. Results: Participants were allocated to CBT (n = 242) or TAU (n = 245). There was no significant difference between groups on the prespecified primary outcome [PANSS total score at 21 months was 0.89 points lower in the CBT arm than in the TAU arm, 95% confidence interval (CI) –3.32 to 1.55 points; p = 0.475], although PANSS total score at the end of treatment (9 months) was significantly lower in the CBT arm (–2.40 points, 95% CI –4.79 to –0.02 points; p = 0.049). CBT was associated with a net cost of £5378 (95% CI –£13,010 to £23,766) and a net QALY gain of 0.052 (95% CI 0.003 to 0.103 QALYs) compared with TAU. The cost-effectiveness acceptability analysis indicated a low likelihood that CBT was cost-effective, in the primary and sensitivity analyses (probability < 50%). In the CBT arm, 107 participants reported at least one adverse event (AE), whereas 104 participants in the TAU arm reported at least one AE (odds ratio 1.09, 95% CI 0.81 to 1.46; p = 0.58). Conclusions: Cognitive–behavioural therapy for CRS was not superior to TAU on the primary outcome of total PANSS symptoms at 21 months, but was superior on total PANSS symptoms at 9 months (end of treatment). CBT was not found to be cost-effective in comparison with TAU. There was no suggestion that the addition of CBT to TAU caused adverse effects. Future work could investigate whether or not specific therapeutic techniques of CBT have value for some CRS individuals, how to identify those who may benefit and how to ensure that effects on symptoms can be sustained. Trial registration: Current Controlled Trials ISRCTN99672552