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Background Informed consent is an accepted ethical and legal prerequisite for trial participation, yet there is no standardised method of assessing patient understanding for informed consent. The Participatory and Informed Consent (PIC) measure was developed for application to recruitment discussions, to evaluate recruiter information provision and evidence of patient understanding. Preliminary evaluation of the PIC indicated the need to improve inter-rater and intra-rater reliability ratings and conduct further psychometric evaluation. This paper describes the assessment, revision and evaluation of the PIC within the context of OPTiMISE, a pragmatic primary care-based trial. Methods This study used multiple methods across two phases. In phase one, one researcher applied the existing PIC measure to 18 audio recorded recruitment discussions from the OPTiMISE study and made detailed observational notes about any uncertainties in application. Appointments were sampled to be maximally diverse for patient gender, study centre, recruiter and before and after an intervention to optimise information provision. Application uncertainties were reviewed by the study team, revisions made, and a coding manual developed and agreed. In phase two, the coding manual was used to develop tailored guidelines for applying the PIC to appointments within the OPTiMISE trial. Two researchers then assessed 27 further appointments, purposively sampled as above, to evaluate inter-rater and intra-rater reliability, content validity and feasibility. Results Application of the PIC to 18 audio recorded OPTiMISE recruitment discussions resulted in harmonisation of the scales rating recruiter information provision and evidence of patient understanding, minor amendments to clarify wording, and the development of detailed generic coding guidelines for applying the measure within any trial. Application of the revised measure using these guidelines to 27 further recruitment discussions showed good feasibility (time to complete), content validity (completion rate) and reliability (inter- and intra-rater) of the measure. Conclusion The PIC provides a means to evaluate the content of information provided by recruiters, patient participation in recruitment discussions and, to some extent, evidence of patient understanding. Future work will use the measure to evaluate recruiter information provision and evidence of patient understanding both across and within trials.

Background We investigated clinical equipoise across surgical members of the British Elbow and Shoulder Society (BESS) in relation to rehabilitation following rotator cuff repair. Method An online survey explored clinical equipoise regarding early patient-directed versus standard rehabilitation after rotator cuff repair to inform the design of a national randomised controlled trial (RCT). It described different clinical scenarios relating to patient age, tear size, location and whether other patient-related and intra-operative factors would influence equipoise. Results 76 surgeons completed the survey. 81% agreed/ strongly agreed that early mobilisation might benefit recovery; 57% were neutral/ disagreed that this approach risks re-tear. 87% agreed/ strongly agreed that there is clinical uncertainty about the effectiveness of different approaches to rehabilitation. As age of the patient and tear size increased, the proportion of respondents who would agree to recruit and accept the outcome of randomisation reduced, and this was compounded if subscapularis was torn. Other factors that influenced equipoise were diabetes and non-secure repair. Conclusion Surgical members of BESS recognise uncertainty about the effectiveness of different approaches to rehabilitation following rotator cuff repair. We identified a range of factors that influence clinical equipoise that will be considered in the design of a new RCT.

Aims A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial. Methods We collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment. Results Recruiters faced four common obstacles when recruiting to a surgical orthopaedic trial: patient preferences for an intervention; a complex recruitment pathway; various logistical issues; and conflicting views on equipoise. Clinicians expressed concerns that the trial may not show significant differences in the treatments, validating their equipoise. However, they experienced role conflicts due to their own preference and perceived patient preference for an intervention arm. Conclusion This study provided initial information about barriers to recruitment to an orthopaedic randomized controlled trial. We shared these findings in an all-site investigators’ meeting and encouraged researchers to find solutions to identified barriers; this led to the successful completion of recruitment. Complex trials may benefit for using of a mixed-methods approach to mitigate against recruitment failure, and to improve patient participation and informed consent. Cite this article: Bone Jt Open 2021;2(8):631–637.

Objective The overall aim of this study was to investigate how commissioning policies for accessing clinical procedures compare in the context of the English National Health Service. Our primary objective was to compare policy wording and categorise any variations identified. Our secondary objective was to explore how any points of variation relate to national guidance. Methods This study entailed documentary analysis of commissioning policies that stipulated criteria for accessing eight elective musculoskeletal procedures. For each procedure, we retrieved policies held by regions with higher and lower rates of clinical activity relative to the national average. Policies were subjected to content and thematic analysis, using constant comparison techniques . Matrices and descriptive reports were used to compare themes across policies for each procedure and derive categories of variation that arose across two or more procedures. National guidance relating to each procedure were identified and scrutinised, to explore whether these provided context for explaining the policy variations. Results Thirty-five policy documents held by 14 geographic regions were included in the analysis. Policies either focused on a single procedure/treatment or covered several procedures/treatments in an all-encompassing document. All policies stipulated criteria that needed to be fulfilled prior to accessing treatment, but there were inconsistences in the evidence cited. Policies varied in recurring ways, with respect to specification of non-surgical treatments and management, requirements around time spent using non-surgical approaches, diagnostic requirements, requirements around symptom severity and disease progression, and use of language, in the form of terms and phrases (‘threshold modifiers’) which could open up or restrict access to care. National guidance was identified for seven of the procedures, but this guidance did not specify criteria for accessing the procedures in question, making direct comparisons with regional policies difficult. Conclusions This, to our knowledge, is the first study to identify recurring ways in which policies for accessing treatment can vary within a single-payer system with universal coverage. The findings raise questions around whether formulation of commissioning policies should receive more central support to promote greater consistency – especially where evidence is uncertain, variable or lacking.

Background There is limited randomized evidence on the comparative outcomes of early-stage lung cancer resection by video-assisted thoracoscopic surgery (VATS) versus open resection. Methods We conducted a parallel-group multicenter randomized trial that recruited participants with known or suspected early-stage lung cancer and randomly assigned them to open or VATS resection of their lesions. The primary outcome was physical function at 5 weeks as a measure of recovery using the European Organisation for Research and Treatment of Cancer core health-related quality of life questionnaire (QLQ-C30) (scores range from 0 to 100, with higher scores indicating better function; the clinical minimally important difference for improvement is 5 points). We followed the patients for an additional 47 weeks for other outcomes. Results A total of 503 participants were randomly assigned (247 to VATS and 256 to open lobectomy). At 5 weeks, median physical function was 73 in the VATS group and 67 in the open surgery group, with a mean difference of 4.65 points (95% confidence interval, 1.69 to 7.61). Of the participants allocated to VATS, 30.7% had serious adverse events after discharge compared with 37.8% of those allocated to open surgery (risk ratio, 0.81 [95% confidence interval, 0.66 to 1.00]). At 52 weeks, there were no differences in cancer progression-free survival (hazard ratio, 0.74 [0.43 to 1.27]) or overall survival (hazard ratio, 0.67 [0.32 to 1.40]). Comclusions VATS lobectomy for lung cancer is associated with a better recovery of physical function in the 5 weeks after random assignment compared with open surgery. Long-term oncologic outcomes will require continued follow-up to assess. (Funded by the National Institute for Health Research Health Technology Assessment programme [reference number 13/04/03]; ISRCTN number, ISRCTN13472721.)

BackgroundUK FASHIoN was a multicentre randomised controlled trial comparing hip arthroscopic surgery (HA) with personalised hip therapy (PHT, physiotherapist-led conservative care), for patients with hip pain attributed to femoroacetabular impingement (FAI) syndrome. Our aim was to describe the treatment and trial participation experiences of patients, to contextualise the trial results and offer further information to assist treatment decision-making in FAI.MethodsWe conducted in-depth semi-structured telephone interviews with a purposive sample of trial participants from each of the trial arms. They were interviewed after they received treatment and completed their first year of trial participation. Thematic analysis and constant comparison analytical approaches were used to identify themes of patient treatment experiences during the trial.ResultsForty trial participants were interviewed in this qualitative study. Their baseline characteristics were similar to those in the main trial sample. On average, their hip-related quality of life (iHOT-33 scores) at 12 months follow-up were lower than average for all trial participants, indicating poorer hip-related quality of life as a consequence of theoretical sampling. Patient experiences occurred in five patient groups: those who felt their symptoms improved with hip arthroscopy, or with personal hip therapy, patients who felt their hip symptoms did not change with PHT but did not want HA, patients who decided to change from PHT to HA and a group who experienced serious complications after HA. Interviewees mostly described a trouble-free, enriching and altruistic trial participation experience, although most participants expected more clinical follow-up at the end of the trial.ConclusionBoth HA and PHT were experienced as beneficial by participants in the trial. Treatment success appeared to depend partly on patients’ prior own expectations as well as their outcomes, and future research is needed to explore this further. Findings from this study can be combined with the primary results to inform future FAI patients.Trial registrationArthroscopic surgery for hip impingement versus best conventional care (ISRCTN64081839). 28/02/2014.

IntroductionThe post-2005 rise in clinical trials and clinical research conducted in India was accompanied by frequent reports of unethical practices, leading to a series of regulatory changes. We conducted a systematic scoping review to obtain an overview of empirical research pertaining to the ethics of clinical trials/research in India.MethodsOur search strategy combined terms related to ethics/bioethics, informed consent, clinical trials/research and India, across nine databases, up to November 2019. Peer-reviewed research exploring ethical aspects of clinical trials/research in India with any stakeholder groups was included. We developed an evidence map, undertook a narrative synthesis and identified research gaps. A consultation exercise with stakeholders in India helped contextualise the review and identify additional research priorities.ResultsTitles/Abstracts of 9699 articles were screened, full text of 282 obtained and 80 were included. Research on the ethics of clinical trials/research covered a wide range of topics, often conducted with little to no funding. Studies predominantly examined what lay (patients/public) and professional participants (eg, healthcare staff/students/faculty) know about topics such as research ethics or understand from the information given to obtain their consent for research participation. Easily accessible groups, namely ethics committee members and healthcare students were frequently researched. Research gaps included developing a better understanding of the recruitment-informed consent process, including the doctor-patient interaction, in multiple contexts and exploring issues of equity and justice in clinical trials/research.ConclusionThe review demonstrates that while a wide range of topics have been studied in India, the focus is largely on assessing knowledge levels across different population groups. This is a useful starting point, but fundamental questions remain unanswered about informed consent processes and broader issues of inequity that pervade the clinical trials/research landscape. A priority-setting exercise and appropriate funding mechanisms to support researchers in India would help improve the clinical trials/research ecosystem.

AimsCo‐design implies genuine partnership in the generation of knowledge between service users and researchers. Service user involvement in research has been encouraged in government policy, but it is rarely achieved, especially at trial initial stages. Co‐designed with service users, we adapted existing manualised social cognition intervention for people with a first episode of psychosis to a virtual world environment.MethodsWe invited a group of young people who have used mental health services to co‐design a virtual environment to deliver an accessible social cognition intervention to a hard to engage service user group. We used an iterative process with young service users and the design team that included developing initial ideas, creating a prototype and testing the virtual world.ResultsTwenty young service users of local mental healthcare services provided feedback on the design and delivery of the intervention. Reflecting the demographic of the sample, young people felt the virtual environment should be familiar, urban spaces, akin to therapy rooms or classrooms they have used in real‐life situations rather than non‐traditional therapy spaces that were initially proposed.ConclusionThe co‐design process led to the development of a specific design, approach and protocol to be tested in a proof‐of‐concept trial. Young service users were integral to an agile and iterative design. Technological innovations should be routinely co‐designed and co‐produced if they are to realise their potential to deliver acceptable and affordable mental health interventions.

8504 Background: Video assisted thoracoscopic surgery (VATS) is a popular access for lung cancer resection. However, there is limited information from RCTs from in-hospital to one-year clinical efficacy, safety and oncologic outcomes of a minimal access approach. Methods: VIOLET is a parallel group multi-center RCT conducted in 9 centers in the United Kingdom that recruited participants with known or suspected (cT1-3, N0-1 and M0) lung cancer (ISRCTN13472721). Trial protocol: https://bmjopen.bmj.com/content/9/10/e029507.info. Results: From July 2015 to February 2019, 503 participants were randomized to VATS (n=247) or open (n=256) lobectomy. Patients allocated to VATS had less pain with a mean difference (MD) in visual analogue score of -0.54 (95%CI -0.99 to -0.10) despite less analgesic consumption (mean ratio 0.90, 95%CI 0.80 to 1.01). After discharge pain was consistent on multiple sub-scales including overall pain (MD -7.19, -10.59 to -3.80), chest pain (MD -4.66, -7.96 to -1.36) and an 18% relative risk (RR) reduction in incision pain (RR 0.82; 0.72 to 0.94) up to one-year. Better functional recovery continued in VATS arm after discharge with better physical function (primary outcome) with MD of 4.65 (1.69 to 7.61; P=0.002) at 5 weeks and overall improvement in global health status with a MD of 4.21 (1.62 to 6.79; P=0.001). In hospital, VATS arm had fewer complications (RR 0.74, 0.66 to 0.84; P

Background Osteoarthritis is a significant cause of burden to the ageing population and knee replacement is a common operation for treatment of end-stage disease. We aimed to explore these factors to help understand patients' decision-making, which is critical in informing patient-centred care. These can be used to enhance decision-making and dialogue between clinicians and patients, allowing a more informed choice. Methods The study consisted of two focus groups, in a patient cohort after total knee replacement followed by more in-depth interviews to further test and explore themes from the focus groups, in patients in either the deliberation stage or the decision-making stage. Results Using qualitative research methods (iterative thematic analysis) reviewing decision-making and deliberation phases of making informed choices we found nine key themes that emerged from the study groups. Conclusions An awareness of the deliberation phase, the factors that influence it, the stress associated with it, preferred models of care, and the influence of the decision-making threshold will aid useful communication between doctors and patients.

BACKGROUND:\ud Femoroacetabular impingement (FAI) is a syndrome of hip or groin pain associated with shape abnormalities of the hip joint. Treatments include arthroscopic surgery and conservative care. This study explored the feasibility of a randomised controlled trial to compare these treatments.\ud OBJECTIVES:\ud The objectives of this study were to estimate the number of patients available for a full randomised controlled trial (RCT); to explore clinician and patient willingness to participate in such a RCT; to develop consensus on eligibility criteria, surgical and best conservative care protocols; to examine possible outcome measures and estimate the sample size for a full RCT; and to develop trial procedures and estimate recruitment and follow-up rates.\ud METHODS:\ud Pre-pilot work: we surveyed all UK NHS hospital trusts (n = 197) to identify all FAI surgeons and to estimate how much arthroscopic FAI surgery they performed. We interviewed a purposive sample of 18 patients, 36 physiotherapists, 18 surgeons and two sports physicians to explore attitudes towards a RCT and used consensus-building methods among them to develop treatment protocols and patient information. Pilot RCT: we performed a pilot RCT in 10 hospital trusts. Patients were randomised to receive either hip arthroscopy or best conservative care and then followed up at 3, 6 and 12 months using patient-reported questionnaires for hip pain and function, activity level, quality of life, and a resource-use questionnaire. Qualitative recruitment intervention: we performed semistructured interviews with all researchers and clinicians involved in the pilot RCT in eight hospital trusts and recorded and analysed diagnostic and recruitment consultations with eligible patients.\ud RESULTS:\ud We identified 120 surgeons who reported treating at least 1908 patients with FAI by hip arthroscopy in the NHS in the financial year 2011/12. There were 34 hospital trusts that performed ≥ 20 arthroscopic FAI operations in the year. We found that clinicians were positive about a RCT: only half reported equipoise, but most said that they would be prepared to randomise patients. Patients strongly supported a RCT, but expressed concerns about its design; these were used to develop patient information for the pilot RCT. We developed a surgical protocol and showed that this could be used in a RCT. We developed a physiotherapy-led exercise-based package of best conservative care called 'personalised hip therapy' and showed that this was practicable. In the pilot RCT, we recruited 42 out of 60 eligible patients (70%) across nine sites. The mean duration and recruitment rate across all sites were 4.5 months and one patient per site per month, respectively. The lead site recruited for the longest period (9.3 months) and accrued the largest number of patients (2.1 patients per month). We recorded and analysed 84 diagnostic and recruitment consultations in 60 patients and used these to develop a model for an optimal recruitment consultation. We identified the International Hip Outcome Tool at 12 months as an appropriate outcome measure and estimated the sample size for a full trial as 344 participants: a number that could be recruited in 25 centres over 18 months.\ud CONCLUSION:\ud We have demonstrated that it is feasible to perform a RCT to establish the clinical effectiveness of hip arthroscopy compared with best conservative care for FAI. We have designed a full trial and developed and tested procedures for it, including an innovative approach to recruitment. We propose that a full trial be implemented.

Background\ud Femoroacetabular impingement syndrome is an important cause of hip pain in young adults. It can be treated by arthroscopic hip surgery, including reshaping the hip, or with physiotherapist-led conservative care. We aimed to compare the clinical effectiveness of hip arthroscopy with best conservative care.\ud \ud Methods\ud UK FASHIoN is a pragmatic, multicentre, assessor-blinded randomised controlled trial, done at 23 National Health Service hospitals in the UK. We enrolled patients with femoroacetabular impingement syndrome who presented at these hospitals. Eligible patients were at least 16 years old, had hip pain with radiographic features of cam or pincer morphology but no osteoarthritis, and were believed to be likely to benefit from hip arthroscopy. Patients with bilateral femoroacetabular impingement syndrome were eligible; only the most symptomatic hip was randomly assigned to treatment and followed-up. Participants were randomly allocated (1:1) to receive hip arthroscopy or personalised hip therapy (an individualised, supervised, and progressive physiotherapist-led programme of conservative care). Randomisation was stratified by impingement type and recruiting centre and was done by research staff at each hospital, using a central telephone randomisation service. Patients and treating clinicians were not masked to treatment allocation, but researchers who collected the outcome assessments and analysed the results were masked. The primary outcome was hip-related quality of life, as measured by the patient-reported International Hip Outcome Tool (iHOT-33) 12 months after randomisation, and analysed in all eligible participants who were allocated to treatment (the intention-to-treat population).\ud \ud This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN64081839, and is closed to recruitment. Findings Between July 20, 2012, and July 15, 2016, we identified 648 eligible patients and recruited 348 participants: 171 participants were allocated to receive hip arthroscopy and 177 to receive personalised hip therapy. Three further patients were excluded from the trial after randomisation because they did not meet the eligibility criteria. Follow-up at the primary outcome assessment was 92% (319 of 348 participants). At 12 months after randomisation, mean iHOT-33 scores had improved from 39·2 (SD 20·9) to 58·8 (27·2) for participants in the hip arthroscopy group, and from 35·6 (18·2) to 49·7 (25·5) in the personalised hip therapy group. In the primary analysis, the mean difference in iHOT-33 scores, adjusted for impingement type, sex, baseline iHOT-33 score, and centre, was 6·8 (95% CI 1·7–12·0) in favour of hip arthroscopy (p=0·0093). This estimate of treatment effect exceeded the minimum clinically important difference (6·1 points). There were 147 patient-reported adverse events (in 100 [72%] of 138 patients) in the hip arthroscopy group) versus 102 events (in 88 [60%] of 146 patients) in the personalised hip therapy group, with muscle soreness being the most common of these (58 [42%] vs 69 [47%]). There were seven serious adverse events reported by participating hospitals. Five (83%) of six serious adverse events in the hip arthroscopy group were related to treatment, and the one in the personalised hip therapy group was not. There were no treatment-related deaths, but one patient in the hip arthroscopy group developed a hip joint infection after surgery. Interpretation Hip arthroscopy and personalised hip therapy both improved hip-related quality of life for patients with femoroacetabular impingement syndrome. Hip arthroscopy led to a greater improvement than did personalised hip therapy, and this difference was clinically significant. Further follow-up will reveal whether the clinical benefits of hip arthroscopy are maintained and whether it is cost effective in the long term.\ud \ud Funding\ud The Health Technology Assessment Programme of the National Institute of Health Research.

Background: Addressing specific social cognitive difficulties is an important target in early psychosis and may help address poor functional outcomes. However, structured interventions using standard therapy settings including groups suffer from difficulties in recruitment and retention.\ud \ud Aims: To address these issues, we aimed to modify an existing group social cognitive intervention entitled ‘Social Cognition and Interaction Training' (SCIT) to be delivered through a virtual world environment (Second Life ©).\ud \ud Methods: A single arm nonrandomized proof-of-concept trial of SCIT-VR was conducted. Five groups of three to five individuals per group were recruited over 6 months. Eight sessions of SCIT-VR therapy were delivered through the virtual world platform Second Life© over a 5-week intervention window. Feasibility was examined using recruitment rates and retention. Acceptability was examined using qualitative methods. Secondary outcomes including social cognitive indices, functioning, and anxiety were measured pre- and postintervention.\ud \ud Results: The SCIT-VR therapy delivered was feasible (36% consent rate and 73.3% intervention completion rate), acceptable (high overall postsession satisfaction scores) and safe (no serious adverse events), and had high levels of participant satisfaction. Users found the environment immersive. Prepost changes were found in emotion recognition scores and levels of anxiety. There were no signs of clinical deterioration on any of the secondary measures.\ud \ud Conclusion: This proof-of-concept pilot trial suggested that delivering SCIT-VR through a virtual world is feasible and acceptable. There were some changes in prepost outcome measures that suggest the intervention has face validity. There is sufficient evidence to support a larger powered randomized controlled trial.\ud \ud Clinical Trial Registration: ISRCTN, identifier 41443166

Objectives: How a randomized controlled trial (RCT) is explained to patients is a key determinant of recruitment to that trial. This study developed and implemented a simple six-step model to fully inform patients and to support them in deciding whether to take part or not.Study Design and Setting: Ninety-two consultations with 60 new patients were recorded and analyzed during a pilot RCT comparing surgical and nonsurgical interventions for hip impingement. Recordings were analyzed using techniques of thematic analysis and focused conversation analysis.Results: Early findings supported the development of a simple six-step model to provide a framework for good recruitment practice. Model steps are as follows: (1) explain the condition, (2) reassure patients about receiving treatment, (3) establish uncertainty, (4) explain the study purpose, (5) give a balanced view of treatments, and (6) Explain study procedures. There are also two elements throughout the consultation: (1) responding to patients’ concerns and (2) showing confidence. The pilot study was successful, with 70% (n 5 60) of patients approached across nine centers agreeing to take part in the RCT, so that the full-scale trial was funded. Conclusion: The six-step model provides a promising framework for successful recruitment to RCTs. Further testing of the model is now required.

BackgroundFemoroacetabular impingement (FAI) is a syndrome of hip or groin pain associated with shape abnormalities of the hip joint. Treatments include arthroscopic surgery and conservative care. This study explored the feasibility of a randomised controlled trial to compare these treatments.ObjectivesThe objectives of this study were to estimate the number of patients available for a full randomised controlled trial (RCT); to explore clinician and patient willingness to participate in such a RCT; to develop consensus on eligibility criteria, surgical and best conservative care protocols; to examine possible outcome measures and estimate the sample size for a full RCT; and to develop trial procedures and estimate recruitment and follow-up rates.MethodsPre-pilot work: we surveyed all UK NHS hospital trusts (n = 197) to identify all FAI surgeons and to estimate how much arthroscopic FAI surgery they performed. We interviewed a purposive sample of 18 patients, 36 physiotherapists, 18 surgeons and two sports physicians to explore attitudes towards a RCT and used consensus-building methods among them to develop treatment protocols and patient information. Pilot RCT: we performed a pilot RCT in 10 hospital trusts. Patients were randomised to receive either hip arthroscopy or best conservative care and then followed up at 3, 6 and 12 months using patient-reported questionnaires for hip pain and function, activity level, quality of life, and a resource-use questionnaire. Qualitative recruitment intervention: we performed semistructured interviews with all researchers and clinicians involved in the pilot RCT in eight hospital trusts and recorded and analysed diagnostic and recruitment consultations with eligible patients.ResultsWe identified 120 surgeons who reported treating at least 1908 patients with FAI by hip arthroscopy in the NHS in the financial year 2011/12. There were 34 hospital trusts that performed ≥ 20 arthroscopic FAI operations in the year. We found that clinicians were positive about a RCT: only half reported equipoise, but most said that they would be prepared to randomise patients. Patients strongly supported a RCT, but expressed concerns about its design; these were used to develop patient information for the pilot RCT. We developed a surgical protocol and showed that this could be used in a RCT. We developed a physiotherapy-led exercise-based package of best conservative care called ‘personalised hip therapy’ and showed that this was practicable. In the pilot RCT, we recruited 42 out of 60 eligible patients (70%) across nine sites. The mean duration and recruitment rate across all sites were 4.5 months and one patient per site per month, respectively. The lead site recruited for the longest period (9.3 months) and accrued the largest number of patients (2.1 patients per month). We recorded and analysed 84 diagnostic and recruitment consultations in 60 patients and used these to develop a model for an optimal recruitment consultation. We identified the International Hip Outcome Tool at 12 months as an appropriate outcome measure and estimated the sample size for a full trial as 344 participants: a number that could be recruited in 25 centres over 18 months.ConclusionWe have demonstrated that it is feasible to perform a RCT to establish the clinical effectiveness of hip arthroscopy compared with best conservative care for FAI. We have designed a full trial and developed and tested procedures for it, including an innovative approach to recruitment. We propose that a full trial be implemented.FundingThe National Institute for Health Research Health Technology Assessment programme.

Purpose – There is growing interest in self-management support for people living with mental health problems. The purpose of this paper is to describe the evaluation of a co-designed and co-delivered self-management programme (SMP) for people living with depression delivered as part of large scale National Health Service quality improvement programme, which was grounded in the principles of co-production. The authors investigated whether participants became more activated, were less psychologically distressed enjoyed better health status, and quality of life, and improved their self-management skills after attending the seven-week SMP. Design/methodology/approach – The authors conducted a longitudinal study of 114 people living with depression who attended the SMP. Participants completed self-reported measures before attending the SMP and at six months follow up. Findings – Patient activation significantly improved six months after the SMP (baseline M=49.6, SD=12.3, follow up M=57.2, SD=15.0, t(113)=4.83, p < 0.001; d=0.61). Participants’ experience of depression symptoms as measured by the Patient Health Questionnaire-9 significantly reduced (baseline M=15.5, SD=6.8, follow up M=10.6, SD=6.9, t(106)=7.22, p < 0.001, d=−0.72). Participants’ anxiety and depression as measured by the Hospital Anxiety Depression Scale also decreased significantly (baseline anxiety: M=13.1, SD=4.2, follow up M=10.2, SD=4.4, t(79)=6.29, p < 0.001, d=−0.69); (baseline depression: M=10.3, SD=4.6, follow up M=7.7, SD=4.5, t(79)=5.32, p < 0.001, d=−0.56). The authors also observed significant improvement in participants’ health status (baseline M=0.5, SD=0.3, follow up M=0.6, SD=0.3, t(97)=−3.86, p < 0.001, d=0.33), and health-related quality of life (baseline M=45.4, SD=20.5, follow up M=60.8, SD=22.8, t(91)=−2.71, p=0.008, d=0.75). About 35 per cent of participant showed substantial improvements of self-management skills. Originality/value – The co-produced depression SMP is innovative in a UK mental health setting. Improvements in activation, depression, anxiety, quality of life and self-management skills suggest that the SMP could make a useful contribution to the recovery services in mental health.

BackgroundUnderstanding the relative risks of maintenance treatment versus discontinuation of antipsychotics following remission in first episode psychosis (FEP) is an important area of practice.MethodA systematic review and meta-analysis. Prospective experimental studies including a parallel control group were identified to compare maintenance antipsychotic treatment with total discontinuation or medication discontinuation strategies following remission in FEP.ResultsSeven studies were included. Relapse rates were higher in the discontinuation group (53%; 95% CIs: 39%, 68%; N = 290) compared with maintenance treatment group (19%; 95% CIs: 0.05%, 37%; N = 230). In subgroup analyses, risk difference of relapse was lower in studies with a longer follow-up period, a targeted discontinuation strategy, a higher relapse threshold, a larger sample size, and samples with patients excluded for drug or alcohol dependency. Insufficient studies included psychosocial functioning outcomes for a meta-analysis.ConclusionsThere is a higher risk of relapse for those who undergo total or targeted discontinuation strategies compared with maintenance antipsychotics in FEP samples. The effect size is moderate and the risk difference is lower in trials of targeted discontinuation strategies.Declaration of interestA.T. has received honoraria and support from Janssen-Cilag and Otsuka Pharmaceuticals for meetings and has been has been an investigator on unrestricted investigator-initiated trials funded by AstraZeneca and Janssen-Cilag. He has also previously held a Pfizer Neurosciences Research Grant. S.M. has received sponsorship from Otsuka and Lundbeck to attend an academic congress and owns shares in GlaxoSmithKline and AstraZeneca. J.H. has attended meetings supported by Sunovion Pharmaceuticals.

Objectives: To disentangle the effects of physician gender and patient-centered communication style on patients' oral engagement in depression care. Methods: Physician gender, physician race and communication style (high patient-centered (HPC) and low patient-centered (LPC)) were manipulated and presented as videotaped actors within a computer simulated medical visit to assess effects on analogue patient (AP) verbal responsiveness and care ratings. 307 APs (56% female; 70% African American) were randomly assigned to conditions and instructed to verbally respond to depression-related questions and indicate willingness to continue care. Disclosures were coded using Roter Interaction Analysis System (RIAS). Results: Both male and female APs talked more overall and conveyed more psychosocial and emotional talk to HPC gender discordant doctors (all p

IntroductionFemoroacetabular impingement (FAI) syndrome is increasingly recognised as a cause of hip pain. As part of the design of a randomised controlled trial (RCT) of arthroscopic surgery for FAI syndrome, we developed a protocol for non-operative care and evaluated its feasibility.MethodsIn phase one, we developed a protocol for non-operative care for FAI in the UK National Health Service (NHS), through a process of systematic review and consensus gathering. In phase two, the protocol was tested in an internal pilot RCT for protocol adherence and adverse events.ResultsThe final protocol, called Personalised Hip Therapy (PHT), consists of four core components led by physiotherapists: detailed patient assessment, education and advice, help with pain relief and an exercise-based programme that is individualised, supervised and progressed over time. PHT is delivered over 12–26 weeks in 6–10 physiotherapist-patient contacts, supplemented by a home exercise programme. In the pilot RCT, 42 patients were recruited and 21 randomised to PHT. Review of treatment case report forms, completed by physiotherapists, showed that 13 patients (62%) received treatment that had closely followed the PHT protocol. 13 patients reported some muscle soreness at 6 weeks, but there were no serious adverse events.ConclusionPHT provides a structure for the non-operative care of FAI and offers guidance to clinicians and researchers in an evolving area with limited evidence. PHT was deliverable within the National Health Service, is safe, and now forms the comparator to arthroscopic surgery in the UK FASHIoN trial (ISRCTN64081839).Trial registration numberISRCTN 09754699.

Background There is approximately a 17 % dissatisfaction rate with knee replacements. Calls for tools that can pre-operatively identify patients at risk of being dissatisfied have been widespread. However, it is not known how to present such information to patients, how it would affect their decision making process, and at what part of the pathway such a tool should be used. Methods Using focus groups involving 12 participants and in-depth interviews with 10 participants, we examined how individual predictions of outcome could affect patients’ decision making by providing fictitious predictions to patients at different stages of treatment. A thematic analysis was used to analyse the data. Results Our results demonstrate several interesting findings. Firstly, patients who have received information from friends and family are unwilling to adjust their expectation of outcome down (i.e. to a worse outcome), but highly willing to adjust it up (to a better outcome). This is an example of the optimism bias, and suggests that the effect on expectation of a poor outcome prediction would be blunted. Secondly, patients generally wanted a “bottom line” outcome, rather than lots of detail. Thirdly, patients who were earlier in their treatment for osteoarthritis were more likely to find the information useful, and it was more likely to affect their decision, than patients later in their treatment pathway. Conclusion This research suggest that an outcome prediction tool would have most effect targeted towards people at the start of their treatment pathway, with a “bottom line” prediction of outcome. However, any effect on expectation and decision making of a poor outcome prediction is likely to be blunted by the optimism bias. These findings merit replication in a larger sample size. Electronic supplementary material The online version of this article (doi:10.1186/s12891-016-1165-x) contains supplementary material, which is available to authorized users.

Objective:\ud \ud The mode of delivery of trial information is a key determinant of recruitment to randomised controlled trials (RCTs), which can be modified in order to encourage patients to participate. This paper presents the development and initial validation of a simple six-step model to support recruitment.\ud \ud Study design and setting:\ud \ud 92 recruitment consultations with 60 new patients were recorded and analysed during a pilot RCT comparing surgical and non-surgical interventions for hip impingement. Recordings were analysed using techniques of thematic analysis and focused conversation analysis pioneered in previous studies. Analysis of recordings continued during the full-scale trial.\ud \ud Results:\ud \ud The pilot study was successful, with 70% of patients approached across 9 centres agreeing to take part in the RCT, and the full-scale trial has achieved 75% recruitment in 19 centres. A simple six-step model providing a framework for good recruitment practice was developed at the pilot phase and then validated, and tested in the main trial. The model enabled recruiters to explain the design and conduct of the RCT and provide reassuring information for patients in the context of consultations very different from routine practice.\ud \ud Conclusion:\ud \ud The six-step model provides a useful framework for recruitment to RCTs. It encourages the implementation of good RCT recruitment practice and provides strategies to support recruiters. The model requires further testing in a wide range of RCTs and clinical contexts.

Background The general practice (GP) workforce in England is in crisis, reflected in increasing rates of early retirement and intentions to reduce hours of working. This study aimed to investigate underlying factors and how these might be mitigated. Methods GPs in central England were invited to participate in an on-line survey exploring career plans and views and experiences of work-related pressures. Quantitative data were analysed using logistic regression analysis and principal components analysis. Qualitative data were analysed using a thematic framework approach. Results Of 1,192 GPs who participated, 978 (82.0 %) stated that they intend to leave general practice, take a career break and/or reduce clinical hours of work within the next five years. This included 488 (41.9 %) who intend to leave practice, and almost a quarter (279; 23.2 %) intending to take a career break. Only 67 (5.6 %) planned to increase their hours of clinical work. For participants planning to leave practice, the issues that most influenced intentions were volume and intensity of workload, time spent on “unimportant tasks”, introduction of seven-day working and lack of job satisfaction. Four hundred fifty five participants responded to open questions (39128 words in total). The main themes were the cumulative impact of work-related pressures, the changing and growing nature of the workload, and the consequent stress. Reducing workload intensity, workload volume, administrative activities, with increased time for patient care, no out-of-hour commitments, more flexible working conditions and greater clinical autonomy were identified as the most important requirements to address the workforce crisis. In addition, incentive payments, increased pay and protected time for education and training were also rated as important. Conclusions New models of professionalism and organisational arrangements may be needed to address the issues described here. Without urgent action, the GP workforce crisis in England seems set to worsen. Electronic supplementary material The online version of this article (doi:10.1186/s12875-015-0363-1) contains supplementary material, which is available to authorized users.

Therapeutic Communities for Psychosis offers a uniquely global insight into the renewed interest in the use of therapeutic communities for the treatment of psychosis, as complementary to pharmacological treatment. Within this edited volume contributors from around the world look at the range of treatment programmes on offer in therapeutic communities for those suffering from psychosis

This paper presents a case study evaluation of self-management training courses for clinicians working with patients with COPD and Depression, at three NHS sites in United Kingdom. These courses were part of the Health Foundation's Co-Creating Health Initiative project and were co-delivered by a trained patient and clinician tutors. Interviews with 30 clinician attendees, four clinician tutors and two patient tutors suggested that the course content and delivery style were valued by everyone and clinicians reported a higher use of self-management skills following training. Analyses of the video-recorded consultation sessions of two trained clinicians showed limited use of co-production skills.

Pragmatic multi-centre RCTs are acknowledged to be the best design for evaluating the effectiveness of health care interventions as they provide robust evidence of effect, but they often encounter recruitment difficulties. Randomised Controlled Trials (RCTs) in surgery require patients to accept uncertainty or equipoise between surgical and non-surgical treatments as well as to achieve a good understanding of the trial procedures. A qualitative study was conducted to explore the acceptability amongst patients of a RCT comparing hip arthroscopy for femoroacetabular impingement (FAI) versus nonoperative treatment and to help improve trial participant information for a subsequent pilot RCT. Eighteen patients who had been diagnosed with FAI and had received either surgery (N=13) or nonoperative treatment (N=5) were interviewed about their treatment experiences. They were also asked to evaluate the adequacy and readability of the participant information sheets. Results suggested that patients who are better informed about their health condition and possible treatments are more able to accept uncertainty amongst clinicians than those with limited knowledge. Patients were more inclined to accept randomisation if i. they felt the treatment was individualised to their needs, and ii. the same clinician would provide care. The findings of the study helped to brand the nonoperative intervention arm in a user-friendly way. The current recruitment rate of the pilot RCT is 70%. Collaborating with former patients in developing and optimising patient information sheet and exploring the acceptability of trials could contribute to improving informed consent and recruitment rates in future RCT.

R : URGENT The published literature suggests uncertainty about whether operative or nonoperative treatments are best for femoroacetabular impingement (FAI). Without the same level of uncertainty (equipoise) amongst surgeons, a RCT will be challenging. A qualitative study was conducted to explore the level of equipoise amongst arthroscopic FAI surgeons. In phase 1, 14 hip arthroscopy surgeons were interviewed and asked to make treatment decisions based on real life cases that included actively recruiting patients to a theoretical RCT. In phase 2, 9 hip arthroscopy hip surgeons participating in a pilot RCT were interviewed about their experiences so far of taking part in a pilot RCT. Five surgeons took part in both phase 1 and 2. Sixteen (89%) surgeons believed that they were in equipoise and that a RCT was required to generate superior scientific evidence and guidelines for the care. Despite this 5 (36%) surgeons showed a lack of active clinical equipoise when faced with real life case scenarios or discussing involvement with a pilot RCT. Some of the reasons behind surgeons’ lack of equipoise, ranged from lack of belief in the FAI pathology, to personal enthusiasm and gut instinct about the efficacy of surgery on one hand; but conservatism on the other. Although many would like a RCT to guide care, there may be particular challenges amongst this same population when actively recruiting patients to a RCT. Qualitative methodology can be used to help design surgical RCTs and address any subsequent difficulties with recruitment.