The experiences of dietitian's working in care homes in England: a qualitative study.

BACKGROUND: The provision of appropriate nutritional care in care homes is a priority for health services in England. There is limited evidence demonstrating the role of dietitians within older people care homes. This study explores the experiences of dietitians working with care homes for older people in England. METHODS: A qualitative study using semi-structured face-to-face or telephone interviews was conducted. Criterion and snowball purposive sampling recruited six dietitian participants. Interviews were audio recorded and transcribed verbatim. A reflexive diary was completed, and data analyses followed interpretative phenomenological analyses. Constant comparison, code-recode audits, independent coding by a supervisor, supervisory support and peer review were used to promote rigour. RESULTS: Two key themes and three subthemes were identified: Theme 1 is collaboration with multidisciplinary team (MDT) professionals and its two subthemes are as follows: using support strategies (pathway/standards implementation, training/education and resident dietetic assessment) and delivering value (by benefitting more residents, demonstrating unique dietetic skills, nutritional prescription savings and meeting other professional's knowledge gap). Theme 2 is communication with MDT professionals and its subtheme is the understanding of the dietitian's role and of nutritional care. CONCLUSION: Dietitians believe that they play a key role in supporting care homes with nutritional care, identifying themselves as experts and leaders, working with MDT professionals. The findings highlight the importance of a consistent approach to managing nutrition and the need for dietitians to share outcome data to improve the limited evidence-base. There is a need to agree a defined dietetic service provision to care homes in England.

Therapy-based exercise from the perspective of adult patients: a qualitative systematic review conducted using an ethnographic approach.

OBJECTIVES: Many patients do not meet recommended levels of therapy-based exercise. This review aims to explore how adult patients view being prescribed therapy-based exercise, the information/education they are given and receive and if/how they independently practise and adhere. DESIGN: A qualitative systematic review conducted using an ethnographic approach and in accordance with the PRISMA statement. SOURCES: PubMed, CINAHL, SCOPUS and EMBASE databases (01 January 2000-31 December 2018). METHODS: Qualitative studies with a focus on engagement/adherence with therapy-based exercise were included. Data extraction and quality appraisal were undertaken by two reviewers. Results were discussed and data synthesized. RESULTS: A total of 20,294 titles were screened, with data extracted from 39 full texts and data from 18 papers used to construct three themes. 'The Guidance received' suggests that the type of delivery desired to support and sustain engagement was context-dependent and individually situated. 'The Therapist as teacher' advocates that patients see independent therapy-based exercise as a shared activity and value caring, kind and professional qualities in their therapist. 'The Person as learner' proposes that when having to engage with and practise therapy-based exercise because of ill-health, patients often see themselves as new learners who experience fear and uncertainty about what to do. Patients may have unacknowledged ambivalences about learning that impact on engagement and persistence. CONCLUSION: The quality of the interaction between therapists and patients appears integral to patients engaging with, and sustaining practice of, rehabilitation programmes. Programmes need to be individualized, and health care professionals need to take patients' previous experiences and ambivalences in motivation and empowerment into account.

Are corticosteroid injections more beneficial than anaesthetic injections alone in the management of rotator cuff-related shoulder pain? A systematic review.

OBJECTIVE: To compare the effectiveness of corticosteroid injections to local anaesthetic injections in the management of rotator cuff-related shoulder pain (RCRSP). DESIGN: Systematic review with best evidence synthesis. DATA SOURCES: The Cochrane, PubMed, CINAHL Plus, PEDro and EMBASE electronic databases were searched (inception until 8 June 2017). Reference lists of included articles were also hand searched. ELIGIBILITY CRITERIA: Two reviewers independently evaluated eligibility. Randomised controlled trials (RCTs) were included if they compared subacromial injections of corticosteroid with anaesthetic injections. Two reviewers independently extracted data regarding short-term, midterm and long-term outcomes for pain, self-reported function, range of motion and patient-perceived improvement. RESULTS: Thirteen RCTs (n=1013) were included. Four trials (n=475) were judged as being at low risk of bias. Three studies of low risk of bias favoured the use of corticosteroid over anaesthetic-only injections in the short term (up to 8 weeks). There was strong evidence of no significant difference between injection types in midterm outcomes (12-26 weeks). There was limited evidence of no significant difference between injection types in long-term outcomes. CONCLUSION: Corticosteroid injections may have a short-term benefit (up to 8 weeks) over local anaesthetic injections alone in the management of RCRSP. Beyond 8 weeks, there was no evidence to suggest a benefit of corticosteroid over local anaesthetic injections. TRIAL REGISTRATION NUMBER: PROSPERO CRD42016033161.

Spinal Orthoses for Vertebral Osteoporosis and Osteoporotic Vertebral Fracture: A Systematic Review.

OBJECTIVE: To systematically review the evidence of effectiveness of spinal orthoses for adults with vertebral osteoporosis. DATA SOURCES: We conducted a systematic literature search using the databases of PubMed, MEDLINE, EMBASE, AMED, CINAHL, PEDro, and the Cochrane Library from January 1995 to October 2014. STUDY SELECTION: Two reviewers evaluated eligibility. Randomized controlled trials (RCTs), pilot RCTs, and prospective nonrandomized controlled studies of spinal orthoses for people with vertebral osteoporosis or osteopenia with and without osteoporotic vertebral fracture (OVF) that examined outcomes related to fracture consolidation, pain, strength, posture, balance, physical function, quality of life, and complications were eligible. DATA EXTRACTION: Two reviewers independently extracted data and evaluated methodological quality using a domain-based risk-of-bias approach. DATA SYNTHESIS: Twelve studies were included: 8 RCTs or pilot RCTs and 4 nonrandomized studies involving 626 participants. Three studies (n=153) evaluated orthoses after acute OVF; none were of high quality. Complications were highest with rigid orthoses. Evidence that orthoses could affect vertebral deformity was lacking. Nine studies (n=473) of varying quality considered orthoses in subacute and longer rehabilitation. Three suggested a semirigid backpack thoracolumbar orthosis (TLO) could benefit strength, pain, posture, and quality of life. One found a weighted kypho-orthosis (WKO) improved balance. CONCLUSIONS: The limited evidence about orthoses after acute OVF is inconclusive; better evidence of efficacy is needed, particularly when considering complications. The promising evidence regarding the backpack TLO and WKO needs to be explored further in studies of sufficient size and quality that include men.

The pathophysiology associated with primary (idiopathic) frozen shoulder: A systematic review.

BACKGROUND: Frozen shoulder is a common yet poorly understood musculoskeletal condition, which for many, is associated with substantial and protracted morbidity. Understanding the pathology associated with this condition may help to improve management. To date this has not been presented in a systematic fashion. As such, the aim of this review was to summarise the pathological changes associated with this primary frozen shoulder. DATABASES: Medline, Embase, CINAHL, AMED, BNI and the Cochrane Library, were searched from inception to 2nd May, 2014. To be included participants must not have undergone any prior intervention. Two reviewers independently conducted the; searches, screening, data extraction and assessment of Risk of Bias using the Cochrane Risk of Bias Assessment Tool for non-Randomised Studies of Interventions (ACROBAT-NRSI). Only English language publications reporting findings in humans were included. The findings were summarised in narrative format. RESULTS: Thirteen observational studies (involving 417 shoulders) were included in the review. Eight studies reported magnetic resonance imaging or arthrography findings and 5 recorded histological findings. When reported mean ages of the participants ranged from 40.0 to 59.8 years. Duration of symptoms ranged from 0 to 30 months. The majority of studies (n = 7) were assessed to be of moderate risk of bias, two studies at high risk and the remaining four were rated as low risk of bias. Study characteristics were poorly reported and there was widespread variety observed between studies in respect of data collection methods and inclusion criteria employed. Pathological changes in the anterior shoulder joint capsule and related structures were commonly reported. Imaging identified pathological changes occurring in the coracohumeral ligament, axillary fold and rotator interval. Obliteration of the subcoracoid fat triangle also appeared to be pathognomonic. Histological studies were inconclusive but suggested that immune, inflammatory and fibrotic changes where associated with primary frozen shoulder. CONCLUSIONS: This systematic review presents a summary of what is currently known about the tissue pathophysiology of primary frozen shoulder. Further studies that use standardised inclusion and exclusion criteria and investigate changes in naïve tissue at different stages of the condition are required.

Living with a symptomatic rotator cuff tear 'bad days, bad nights': a qualitative study.

BACKGROUND: Rotator cuff tears are a common cause of shoulder pain. There is an absence of information about symptomatic rotator cuffs from the patients' perspective; this limits the information clinicians can share with patients and the information that patients can access via sources such as the internet. This study describes the experiences of people with a symptomatic rotator cuff, their symptoms, the impact upon their daily lives and the coping strategies utilised by study participants. METHODS: An interpretive phenomenological analysis approach was used. 20 participants of the UKUFF trial (The United Kingdom Rotator Cuff Surgery Trial) agreed to participate in in-depth semi-structured interviews about their experiences about living with a symptomatic rotator cuff tear. Interviews were digitally recorded and fully transcribed. Field notes, memos and a reflexive diary were used. Data was coded in accordance with interpretive phenomenological analysis. Peer review, code-recode audits and constant comparison of data, codes and categories occurred throughout. RESULTS: The majority of patients described intense pain and severely disturbed sleep. Limited movement and reduced muscle strength were described by some participants. The predominantly adverse impact that a symptomatic rotator cuff tear had upon activities of daily living, leisure activities and occupation was described. The emotional and financial impact and impact upon caring roles were detailed. Coping strategies included attempting to carry on as normally as possible, accepting their condition, using their other arm, using analgesics, aids and adaptions. CONCLUSIONS: Clinicians need to appreciate and understand the intensity and shocking nature of pain that may be experienced by participants with known rotator cuff tears and understand the detrimental impact tears can have upon all areas of patient's lives. Clinicians also need to be aware of the potential emotional impact caused by cuff tears and to ensure that patients needing help for conditions such as depression are speedily identified and provided with support, explanation and appropriate treatment.

A mixed-methods approach exploring acceptability and feasibility of trials designed to test drugs targeting prevention of post-traumatic osteoarthritis after knee injury.

Aims: To explore key stakeholder views around feasibility and acceptability of trials seeking to prevent post-traumatic osteoarthritis (PTOA) following knee injury, and provide guidance for next steps in PTOA trial design. Methods: Healthcare professionals, clinicians, and/or researchers (HCP/Rs) were surveyed, and the data were presented at a congress workshop. A second and related survey was then developed for people with joint damage caused by knee injury and/or osteoarthritis (PJDs), who were approached by a UK Charity newsletter or Oxford involvement registry. Anonymized data were collected and analyzed in Qualtrics. Results: Survey responses (n = 19 HCP/Rs, 39 PJDs) supported studies testing pharmacological agents preventing PTOA. All HCP/Rs and 30/31 (97%) PJDs supported the development of new treatments that improved or delayed knee symptoms and damage to knee structure. PJDs thought that improving structural knee damage was more important than knee symptoms. Both groups found studies more acceptable as expected future benefit and risk of PTOA increased. All drug delivery routes were acceptable. Workshop participants (around n = 60) reflected survey views. Discussions suggested that stratifying using molecular testing for likely drug response appeared to be more acceptable than using characteristics such as sex, age, and BMI. Conclusion: Our findings supported PTOA drug intervention studies, including situations where there is low risk of disease, no expected benefit of treatment, and frequent treatment administration. PJDs appeared less risk-averse than HCP/Rs. This work reinforces the benefits of consensus and involvement work in the co-creation of PTOA drug trial design. Involvement of key stakeholders, such as PJDs with different risks of OA and regulatory representatives, are critical for trial design success.

Exploring the business skills, experiences and preparedness of UK-based private physiotherapists when establishing and developing a physiotherapy business: A hermeneutic phenomenological study.

AIM: To explore the business skills, experiences and preparedness of UK-based private physiotherapists when establishing and developing a physiotherapy business. DESIGN: A hermeneutic phenomenological approach. PARTICIPANTS: Six UK-based private physiotherapy practice owners were recruited via purposive and snowball sampling. METHODS: In-depth, semi-structured video interviews (n = 12) were audio-recorded and transcribed. Field notes, respondent validation and a reflexive diary were used. Data underwent line-by-line analysis, identifying codes and themes. Constant comparison of data, codes and themes occurred throughout. Peer review was utilised, and small sections of data and all emerging codes were independently reviewed. RESULTS: Knowledge acquisition: participants acquired business knowledge from training, external help, and trial-and-error approaches. Improved physiotherapy-related business training was requested. Business skills: Business plans were generally organic or lapsed with time. Success and timing of marketing strategies varied widely. The altruistic nature of many physiotherapists creates difficulties in requesting payments for services. Clinical policies: Lone working risks appeared more weighted towards protecting staff from physical abuse rather than allegations. CONCLUSIONS: Improved physiotherapy-related business support and guidance may be beneficial. Focusing on word-of-mouth, website marketing, and establishing support networks may benefit practice owners. Greater consideration of the potentially negative implications of lone working, particularly accusations of inappropriate sexual behaviour, is recommended.

Comparison of postdischarge physiotherapy versus usual care following primary total knee arthroplasty for osteoarthritis: an exploratory pilot randomized clinical trial.

OBJECTIVE: To evaluate a pilot trial of a postdischarge physiotherapy intervention to improve patient function versus usual physiotherapy in patients undergoing total knee arthroplasty aiming to assess: recruitment rate, feasibility and acceptability of the intervention and control, suitability of outcomes, retention and adverse events and to inform sample size calculation for a definitive trial. DESIGN: Exploratory pilot randomized controlled trial using independent assessment. SETTING: Mixed urban and rural, UK. PARTICIPANTS: Patients undergoing primary, elective unilateral knee arthroplasty for osteoarthritis. INTERVENTION: Two additional home physiotherapy visits of functional weight-bearing exercises, functional task-specific training versus treatment as usual. MAIN OUTCOME: Oxford Knee Score at 12 months. SECONDARY OUTCOMES: completion rates, adverse events, Knee Injury and Osteoarthritis Outcome Score, leg extensor power, timed 10-m walk, timed sit-to-stand, resource use diaries. Assessments completed at baseline (pre-operatively), 3, 6 and 12 months. RESULTS: Of 181 eligible participants 107 (59.1%) were randomized over 13 months, one participant withdrew, no adverse events. Intervention group n = 56 (mean age 67.8), control group n = 51 (mean age 70.8). The difference in mean change of Oxford Knee Scores between groups (intervention--control) at 12 months was 0.2 (95% confidence interval (CI) -3.8, 4.2), P = 0.94. Patient diaries revealed non-trial additional physiotherapy requires improved measurement. CONCLUSIONS: Successful recruitment and retention rates were achieved. The intervention appeared feasible and acceptable but may be suboptimal in intensity given recent research. A sample size of 1271 participants would be required for a fully powered randomized controlled trial using the main outcome. However new outcomes, potentially of greater validity and responsiveness, require consideration.

An exploration of specialist clinicians' experiences and beliefs about inpatient amputee rehabilitation as a pathway option for adult primary amputees.

PURPOSE: To explore specialist amputee physiotherapists' experiences and subsequent views about specialist inpatient rehabilitation (IPR) as a National Health Service (NHS) pathway option for adult primary amputees and their perceptions and beliefs about the effects of inpatient amputee rehabilitation. MATERIALS AND METHODS: A qualitative study using a phenomenological approach. Semi-structured interviews were completed with seven physiotherapists experienced in working in both specialist amputee inpatient and outpatient rehabilitation settings. Interviews were audio-recorded and fully transcribed. Data were analysed using thematic analyses; inductive coding was completed; emerging themes are shown and a conceptual framework was developed. To promote rigour, this study was peer reviewed and coding was done by two people. RESULTS: Clinicians believed inpatient amputee rehabilitation to be the preferred model of rehabilitation for the majority of adult primary amputees. A central theme of healthcare inequality within primary amputee rehabilitation provision emerged with four sub-themes: IPR, outpatient rehabilitation, barriers, the ideal world. Geographical variation was described in: type of rehabilitation provided, timescales of prosthetic rehabilitation provision, fitting a prosthesis with wounds, and the availability of community rehabilitation services. CONCLUSIONS: Healthcare inequality is a central concern identified by clinicians who work within amputee rehabilitation in the UK. Clinicians interviewed believe NHS specialist amputee inpatient rehabilitation should be a more accessible pathway.Implications for rehabilitationClinicians believe healthcare inequality exists within primary amputee rehabilitation provision in the UK National Health Service (NHS).Geographical variation in type of care provision, fitting a prosthesis with wounds, timescales in prosthetic rehabilitation provision and community rehabilitation services were described.Clinicians believe inpatient amputee rehabilitation to be the preferred model of care for the majority of adult primary amputees and should be a more accessible pathway within the NHS.Inpatient rehabilitation facilities may be a way of compensating for amputee rehabilitation inequalities.

Peer Review Processes for Quality Improvement in Health Care Settings and Their Implications for Health Care Professionals: A Meta-Ethnography.

INTRODUCTION: Peer review processes are used to improve professional practice in health care, although no synthesis of existing studies has yet been undertaken. These processes are included in the UK professional revalidation processes for medical practitioners and nurses and midwives but not for allied health professionals. The purpose of this review was to identify, appraise, and synthesize the available qualitative evidence regarding health care professionals' experiences and views about peer review processes and to explore the implications for health care professionals in the United Kingdom. METHODS: Qualitative review using meta-ethnography, reported according to Meta-ethnography Reporting Guidance guidance. Search strategy was developed using MeSH headings. The following data sources were searched: Cumulative Index to Nursing and Allied Health Literature, MEDLINE, and Ovid full text (between May 2007 and May 2019) (one reviewer with librarian support) plus manual searching. Screening, data extraction, and evaluation were undertaken independently by two reviewers. Studies were independently appraised for quality by two reviewers to identify concepts which were compared and developed into a conceptual model by the team. RESULTS: Thirteen studies (937 participants) were included. Findings explored peer review processes and three key components, namely, purpose, process, and peers. Participants' perceptions of peer review processes were categorized by four main concepts: value/benefits, reflection/shared learning, anxiety about the process, and how to improve "buy-in." DISCUSSION: Evidence supports the introduction and use of peer review processes as a quality improvement tool. Further research exploring whether/how to incorporate peer review processes into the process of assessing continuing fitness to practice for allied health professionals seems appropriate. The time and resources required to implement peer review processes are considered barriers to implementation.

Hormone replacement therapy (conjugated oestrogens plus bazedoxifene) for post-menopausal women with symptomatic hand osteoarthritis: primary report from the HOPE-e randomised, placebo-controlled, feasibility study.

Background: Symptomatic hand osteoarthritis is more common in women than in men, and its incidence increases around the age of menopause, implicating oestrogen deficiency. No randomised controlled trials of hormone replacement therapy (HRT) have been done in people with hand osteoarthritis. We aimed to determine the feasibility and acceptability of a form of HRT (conjugated oestrogens plus bazedoxifene) in post-menopausal women with painful hand osteoarthritis. Methods: The HOPE-e feasibility study was a randomised, double-blind, placebo-controlled trial, for which we recruited women aged 40-65 years, for whom 1-10 years had passed after their final menstrual period, with definite hand osteoarthritis and at least two painful hand joints. Participants were recruited across three primary or secondary care sites and from the community and were randomly assigned (1:1) to receive conjugated oestrogens plus bazedoxifene or placebo, orally once every day for 24 weeks, before weaning for 4 weeks until the end of the study. The primary feasibility outcomes were rates of identification, recruitment, randomisation, retention, and compliance of eligible participants, and the likelihood of unmasking. The secondary objective was to generate proof-of-concept quantitative and qualitative data on the acceptability of proposed clinical outcomes for a full trial and adverse events. We used an intention-to-treat analysis, and criteria for progression to a full trial were pre-defined as recruitment of at least 30 participants across all sites in 18 months; a dropout rate of less than or equal to 30% of randomised individuals; and acceptability to the majority of participants, including acceptable rates of adverse events. Due to the COVID-19 pandemic, the recruitment window was reduced to 12-15 months. A proportionately reduced minimum sample size of 22 was judged to be sufficient to test feasibility. This trial was registered at ISRCTN, ISRCTN12196200. Findings: From May 9, 2019 to Dec 31, 2020, 434 enquiries or referrals were received. We did 96 telephone pre-screens; of the 35 eligible participants, seven were excluded as ineligible at the telephone or face-to-face screening and 28 (80% [95% CI 63-92]) were randomly assigned. Of the 406 who were not randomly assigned, 250 (62%) were ineligible (with contraindicated medications accounting for 50 [20%] of these), 101 (25%) did not respond to further enquiries, and 55 (14%) chose not to proceed (with the most common reason being not wanting to take a hormone-based drug). All 28 randomised participants completed all follow-up assessments with high compliance and outcome measure completeness. All three adverse event-related treatment withdrawals were in the placebo group. No serious adverse events were reported. Participants and investigators were successfully masked (participant Bang's blinding index placebo group 0·50 [95% CI 0·25-0·75]). The trial met the prespecified criteria for progression to a full trial. Interpretation: This first-ever feasibility study of a randomised controlled trial of HRT for post-menopausal women with painful hand osteoarthritis met its progression criteria, although it was not powered to detect a clinical effect. This outcome indicates that a full trial of an HRT in this population is feasible and acceptable and identifies potential refinements with regard to the design of such a trial. Funding: Research for Patient Benefit programme, National Institute for Health Research.

"WALK30X5": a feasibility study of a physiotherapy walking programme for people with mild to moderate musculoskeletal conditions.

OBJECTIVES: To explore the feasibility of delivering and evaluating a web-based walking intervention for people with long term musculoskeletal conditions (LTMCs), to determine its acceptability and the feasibility of conducting a definitive trial. DESIGN: Prospective randomised feasibility study, with blind outcome assessment at baseline, 3 and 6 months. SETTING: Hospital based physiotherapy service. PARTICIPANTS: Forty one adults referred for assessment and advice for any mild/moderate LTMCs. doing <120minutes of moderate intensity activity per week. INTERVENTIONS: Participants randomised to: 1. Usual care: one usual physiotherapy advice and assessment session, including setting a physical activity goal and one follow up session (8 weeks). 2. "Walk30×5": session one, usual care plus intervention of walking programme. Participants were shown the website and podcasts and practiced how to use them. One follow up session (8 weeks). OUTCOME MEASURES: Primary: timed six minute walk test (T6MWT). Secondary: step count, self-reported pain, fatigue, mood, self-efficacy, happiness, objective blood pressure, peak expiratory flow rate, and self-report and accelerometer measured physical activity. RESULTS: Recruitment target achieved. No adverse events occurred. Adherence was high and the intervention acceptable. Loss to follow up n=3 (7%) at 3 months, n=8 (20%) at 6 months. T6MWT and step count proved suitable outcomes, unlike accelerometry. Estimated sample size for a definitive trial is 216. CONCLUSIONS: "Walk30×5" is ready for evaluation in a future, appropriately powered (n=216), phase III trial. If effective, the intervention will provide a cheap, highly accessible intervention to enable people with mild/moderate LTMCs to achieve UK physical activity guidelines. CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN78581097.

Divided by a lack of common language? A qualitative study exploring the use of language by health professionals treating back pain.

BACKGROUND: The importance of using a common language when communicating to others about back pain is acknowledged in the literature. There are broadly three areas where difficulties in communication about back pain arise. Firstly, patients seeking information from health care professionals can experience difficulties understanding them and the medical literature; secondly, misunderstandings among health professionals concerning terminology can arise. Thirdly, the lack of standardised definitions for back pain terms can make comparison of research studies problematic. This study aims to explore the meanings and issues surrounding the use of existing medical terms for back pain from the perspective of health care professionals, lay people who have consulted health care practitioners for back pain and lay people who have not seen a health care professional regarding back pain. METHODS: A series of focus groups were used to explore participants' understanding. A purposive sampling approach was used to achieve a sample which included general practitioners, chiropractors, osteopaths, physiotherapists, and lay people. Focus groups were facilitated by an independent professional qualitative researcher. They were audio taped and full transcripts of each focus group underwent line by line analysis, identifying concepts and coded. Constant comparison was used to allow each item to be checked or compared against the rest of the data RESULTS: Lay participants understood the majority of the terms explored in the group differently to the health professionals. The terms, as understood by the lay participants, can be split into three broad categories. Firstly, terms which were not understood or were misconstrued and which had inadvertent negative connotations or implications. Secondly, terms which were not understood or were misconstrued, but without this leading to negative emotional responses. Thirdly, terms which were understood by lay participants as the health professionals stated they intended them to be understood. CONCLUSION: Few of the existing medical terms were understood and accepted by lay participants in the way discussed and expected by health professionals. Misunderstandings, unintended meanings and negative emotional responses to terms were common within the study focus groups.

Effectiveness of physiotherapy exercise following hip arthroplasty for osteoarthritis: a systematic review of clinical trials.

BACKGROUND: Physiotherapy has long been a routine component of patient rehabilitation following hip joint replacement. The purpose of this systematic review was to evaluate the effectiveness of physiotherapy exercise after discharge from hospital on function, walking, range of motion, quality of life and muscle strength, for osteoarthritic patients following elective primary total hip arthroplasty. DESIGN: Systematic review, using the Cochrane Collaboration Handbook for Systematic Reviews of Interventions and the Quorom Statement. Database searches: AMED, CINAHL, EMBASE, KingsFund, MEDLINE, Cochrane library (Cochrane reviews, Cochrane Central Register of Controlled Trials, DARE), PEDro, The Department of Health National Research Register. Handsearches: Physiotherapy, Physical Therapy, Journal of Bone and Joint Surgery (Britain) Conference Proceedings. No language restrictions were applied. SELECTION: Trials comparing physiotherapy exercise versus usual/standard care, or comparing two types of relevant exercise physiotherapy, following discharge from hospital after elective primary total hip replacement for osteoarthritis were reviewed. OUTCOMES: Functional activities of daily living, walking, quality of life, muscle strength and range of hip joint motion. Trial quality was extensively evaluated. Narrative synthesis plus meta-analytic summaries were performed to summarise the data. RESULTS: 8 trials were identified. Trial quality was mixed. Generally poor trial quality, quantity and diversity prevented explanatory meta-analyses. The results were synthesised and meta-analytic summaries were used where possible to provide a formal summary of results. Results indicate that physiotherapy exercise after discharge following total hip replacement has the potential to benefit patients. CONCLUSION: Insufficient evidence exists to establish the effectiveness of physiotherapy exercise following primary hip replacement for osteoarthritis. Further well designed trials are required to determine the value of post discharge exercise following this increasingly common surgical procedure.

Exercise or manual physiotherapy compared with a single session of physiotherapy for osteoporotic vertebral fracture: three-arm PROVE RCT.

BACKGROUND: A total of 25,000 people in the UK have osteoporotic vertebral fracture (OVF). Evidence suggests that physiotherapy may have an important treatment role. OBJECTIVE: The objective was to investigate the clinical effectiveness and cost-effectiveness of two different physiotherapy programmes for people with OVF compared with a single physiotherapy session. DESIGN: This was a prospective, adaptive, multicentre, assessor-blinded randomised controlled trial (RCT) with nested qualitative and health economic studies. SETTING: This trial was based in 21 NHS physiotherapy departments. PARTICIPANTS: The participants were people with symptomatic OVF. INTERVENTIONS: Seven sessions of either manual outpatient physiotherapy or exercise outpatient physiotherapy compared with the best practice of a 1-hour single session of physiotherapy (SSPT). MAIN OUTCOME MEASURES: Outcomes were measured at 4 and 12 months. The primary outcomes were quality of life and muscle endurance, which were measured by the disease-specific QUALEFFO-41 (Quality of Life Questionnaire of the European Foundation for Osteoporosis - 41 items) and timed loaded standing (TLS) test, respectively. Secondary outcomes were (1) thoracic kyphosis angle, (2) balance, evaluated via the functional reach test (FRT), and (3) physical function, assessed via the Short Physical Performance Battery (SPPB), 6-minute walk test (6MWT), Physical Activity Scale for the Elderly, a health resource use and falls diary, and the EuroQol-5 Dimensions, five-level version. RESULTS: A total of 615 participants were enrolled, with 216, 203 and 196 randomised by a computer-generated program to exercise therapy, manual therapy and a SSPT, respectively. Baseline data were available for 613 participants, 531 (86.6%) of whom were women; the mean age of these participants was 72.14 years (standard deviation 9.09 years). Primary outcome data were obtained for 69% of participants (429/615) at 12 months: 175 in the exercise therapy arm, 181 in the manual therapy arm and 173 in the SSPT arm. Interim analysis met the criteria for all arms to remain in the study. For the primary outcomes at 12 months, there were no significant benefits over SSPT of exercise [QUALEFFO-41, difference -0.23 points, 95% confidence interval (CI) -3.20 to 1.59 points; p = 1.000; and TLS test, difference 5.77 seconds, 95% CI -4.85 to 20.46 seconds; p = 0.437] or of manual therapy (QUALEFFO-41, difference 1.35 points, 95% CI -1.76 to 2.93 points; p = 0.744; TLS test, difference 9.69 seconds (95% CI 0.09 to 24.86 seconds; p = 0.335). At 4 months, there were significant gains for both manual therapy and exercise therapy over SSPT in the TLS test in participants aged < 70 years. Exercise therapy was superior to a SSPT at 4 months in the SPPB, FRT and 6MWT and manual therapy was superior to a SSPT at 4 months in the TLS test and FRT. Neither manual therapy nor exercise therapy was cost-effective relative to a SSPT using the threshold of £20,000 per quality-adjusted life-year. There were no treatment-related serious adverse events. CONCLUSIONS: This is the largest RCT to date assessing physiotherapy in participants with OVFs. At 1 year, neither treatment intervention conferred more benefit than a single 1-hour physiotherapy advice session. The focus of future work should be on the intensity and duration of interventions to determine if changes to these would demonstrate more sustained effects. TRIAL REGISTRATION: Current Controlled Trials ISRCTN49117867. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 44. See the NIHR Journals Library website for further project information.

Osteoporosis is a condition in which bones lose their strength and are more likely to break. It affects around 3 million people in the UK. Fractures of the spine are very common in people with osteoporosis. They can cause a change in body shape, back pain and difficulty with carrying out daily tasks. A treatment that may help people is physiotherapy. There is evidence that several different types of physiotherapy, such as exercise or manual (hands-on) therapy, may help. This was the largest trial of physiotherapy for people with osteoporotic vertebral fracture to date. Seven sessions of physiotherapy treatment based on either exercise or manual therapy were compared with a single 1-hour session of individualised advice from a physiotherapist. The outcome of these treatments was assessed using recognised measures of quality of life, back muscle strength, pain, function and activity at 4 months and 1 year after treatment. How safe the treatments were and whether or not they had any impact on falls or the costs of health and social care were also examined. Interviews were conducted with some of the participants in the trial to seek their opinion about the treatment that they had received. The results show that the participants tolerated all the treatments well, with no significant safety issues, and perceived treatment to be beneficial. The study did not find significant differences between the three treatments in terms of clinical effectiveness or cost-effectiveness at 1 year, although there were benefits in some areas at 4 months.

Why participants in The United Kingdom Rotator Cuff Tear (UKUFF) trial did not remain in their allocated treatment arm: a qualitative study.

OBJECTIVE: The UKUFF trial was a three-way parallel group randomised trial comparing surgical and non-surgical treatments for people with rotator cuff tears of their shoulder. High crossover between arms in the UKUFF led to the original trial design being reconfigured; 'Rest then Exercise' was halted. This study explored why participants recruited did not remain within allocated treatment arms and explored crossover and surgical decision making. DESIGN: A qualitative phenomenological approach. PARTICIPANTS: Purposive sampling (n=18) included participants randomised to 'Rest then Exercise' arm considered least likely to proceed to surgery but who had surgery, plus participants from all arms not having surgery. METHODS: In-depth, semi-structured interviews were recorded and transcribed. Field-notes, memos, member-checking and a reflexive diary were used. DATA ANALYSES: In accordance with Interpretative Phenomenological Analysis. Peer review, code-recode audits and constant comparison occurred throughout. RESULTS: 1. Impact of symptoms and diagnosis: these influenced crossover; long durations of severe pain and failed conservative treatment increased eagerness for surgery. 2. Perceptions and expectations of treatment: surgery provided hope for participants, especially when "Rest then Exercise" was perceived as having previously failed. Surgeons were perceived to believe "tears need repairing". 3. Professionals know best: autonomy and communication: patients deciding not to have surgery had to actively leave the surgical waiting list. Increasing age, carer role, self-employment, co-morbidity and improving symptoms were reasons described for declining surgery. CONCLUSIONS: Most participants had failed conservative treatment before trial entry and described strong preferences regarding treatment. Trials should demonstrate patient and clinician equipoise but participants' rarely described equipoise. If conservative treatments are usually provided sequentially in clinical practice, it may be inappropriate to include them as comparators in surgical trials. This is a qualitative study and not eligible for trial registration since it was carried out independently of the UKUFF trial (UKUFF ISRCTN97804283 Date assigned 29/06/2007).

'It is a Big Thing': Exploring the Impact of Osteoarthritis from the Perspective of Adults Caring for Parents - The Sandwich Generation.

PURPOSE: The aim of the present study was to explore the experiences and impact of caring for an individual with severe osteoarthritis (OA) from the perspective of adult children, looking at the relationship between adult children caring for parents with this condition and the tensions of the 'sandwich generation'. METHODS: A mixed qualitative approach, combining focus groups and individual semi-structured interviews was used. In total, 36 participants were purposively sampled and discussed the impact of caring for a parent with OA. Data analysis was based upon interpretative phenomenological analysis. RESULTS: Findings reported the impact and complexity of caring for a parent with OA. We present three themes related to the work of caring for a relative with this condition: (i) the physical and emotional work of caring; (ii) changes in reciprocal family roles; (iii) the imbalance in caring roles within the family. CONCLUSIONS: Participants described the significant and extensive impact on their lives of caring for a parent with long-term OA, particularly when faced with the pressures of caring for their own children as well. Copyright © 2016 The Authors Musculoskeletal Care Published by John Wiley & Sons Ltd.

Validation of complex interventions in a low back pain trial: selective video analysis cross-referenced to clinical case notes.

INTRODUCTION: Auditing the interventions used in clinical trials to demonstrate that treatment protocols were adhered to and that discrete modalities were delivered, is essential in establishing internal validity. Pragmatic studies involving complex interventions provide a particular challenge. The value of case report forms which document individual treatment content relies upon accurate recall and recording by the clinician. This report describes a method to validate this type of data in a randomised clinical trial, by using video analysis on a sample of patient therapist interactions. METHODS: Six physiotherapists used standardised case report forms to record the treatment given to 402 patients recruited into the two treatment arms of a low back pain clinical trial. An audit checklist comprising the principal components of both management approaches was designed. Twelve treatment sessions were video recorded. Three independent clinicians viewed the recordings, using the checklist to identify the treatment content. These data were compared for agreement with the matching case report forms. The content of the interventions delivered to all of the trial patients was then audited. RESULTS: Agreement between the video observers, and between the observers and the case report forms ranged from moderate to very good (kappa=0.45-0.82). When compared with the video observations, some under-reporting of treatment occurred on the case report forms. Overall, 80% of the patients received the treatment to which they were allocated. CONCLUSIONS: This study has demonstrated that selective use of video recording, cross-referenced to clinical case notes may provide a feasible and relatively inexpensive means of establishing the internal validity of the interventions used in a pragmatic clinical trial.