Alba Realpe

Patients’ decision making in total knee arthroplasty: a systematic review of qualitative research

Objectives A patient-centred approach, usually achieved through shared decision making, has the potential to help improve decision making around knee arthroplasty surgery. However, such an approach requires an understanding of the factors involved in patient decision making. This review’s objective is to systematically examine the qualitative literature surrounding patients’ decision making in knee arthroplasty. Methods A systematic literature review using Medline and Embase was conducted to identify qualitative studies that examined patients’ decision making around knee arthroplasty. An aggregated account of what is known about patients’ decision making in knee arthroplasties is provided. Results Seven studies with 234 participants in interviews or focus groups are included. Ten themes are replicated across studies, namely: expectations of surgery; coping mechanisms; relationship with clinician; fear; pain; function; psychological implications; social network; previous experience of surgery; and conflict in opinions. Conclusions This review is helpful in not only directing future research to areas that are not understood, or require confirmation, but also in highlighting areas that future interventions could address. These include those aimed at delivering information, which are likely to affect the satisfaction rate, demand, and use of knee arthroplasties. Cite this article: Bone Joint Res 2015;4;163–169.

Personalised Hip Therapy: development of a non-operative protocol to treat femoroacetabular impingement syndrome in the FASHIoN randomised controlled trial

Introduction Femoroacetabular 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. Methods In 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. Results The 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. Conclusion PHT 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 number ISRCTN 09754699.

The feasibility of conducting a randomised controlled trial comparing arthroscopic hip surgery to conservative care for patients with femoroacetabular impingement syndrome : the FASHIoN feasibility study

To determine whether it was feasible to perform a randomized controlled trial (RCT) comparing arthroscopic hip surgery to conservative care in patients with femoroacetabular impingement (FAI). This study had two phases: a pre-pilot and pilot RCT. In the pre-pilot, we conducted interviews with clinicians who treated FAI and with FAI patients to determine their views about an RCT. We developed protocols for operative and conservative care. In the pilot RCT, we determined the rates of patient eligibility, recruitment and retention, to investigate the feasibility of the protocol and we established methods to assess treatment fidelity. In the pre-pilot phase, 32 clinicians were interviewed, of which 26 reported theoretical equipoise, but in example scenarios 7 failed to show clinical equipoise. Eighteen patients treated for FAI were also interviewed, the majority of whom felt that surgery and conservative care were acceptable treatments. Surgery was viewed by patients as a ‘definitive solution’. Patients were motivated to participate in research but were uncomfortable about randomization. Randomization was more acceptable if the alternative was available at the end of the trial. In the pilot phase, 151 patients were assessed for eligibility. Sixty were eligible and invited to take part in the pilot RCT; 42 consented to randomization. Follow-up was 100% at 12 months. Assessments of treatment fidelity were satisfactory. An RCT to compare arthroscopic hip surgery with conservative care in patients with FAI is challenging but feasible. Recruitment has started for a full RCT.

Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN).

Introduction Femoroacetabular impingement (FAI) syndrome is a recognised cause of young adult hip pain. There has been a large increase in the number of patients undergoing arthroscopic surgery for FAI; however, a recent Cochrane review highlighted that there are no randomised controlled trials (RCTs) evaluating treatment effectiveness. We aim to compare the clinical and cost-effectiveness of arthroscopic surgery versus best conservative care for patients with FAI syndrome. Methods We will conduct a multicentre, pragmatic, assessor-blinded, two parallel arm, RCT comparing arthroscopic surgery to physiotherapy-led best conservative care. 24 hospitals treating NHS patients will recruit 344 patients over a 26-month recruitment period. Symptomatic adults with radiographic signs of FAI morphology who are considered suitable for arthroscopic surgery by their surgeon will be eligible. Patients will be excluded if they have radiographic evidence of osteoarthritis, previous significant hip pathology or previous shape changing surgery. Participants will be allocated in a ratio of 1:1 to receive arthroscopic surgery or conservative care. Recruitment will be monitored and supported by qualitative intervention to optimise informed consent and recruitment. The primary outcome will be pain and function assessed by the international hip outcome tool 33 (iHOT-33) measured 1-year following randomisation. Secondary outcomes include general health (short form 12), quality of life (EQ5D-5L) and patient satisfaction. The primary analysis will compare change in pain and function (iHOT-33) at 12 months between the treatment groups, on an intention-to-treat basis, presented as the mean difference between the trial groups with 95% CIs. The study is funded by the Health Technology Assessment Programme (13/103/02). Ethics and dissemination Ethical approval is granted by the Edgbaston Research Ethics committee (14/WM/0124). The results will be disseminated through open access peer-reviewed publications, including Health Technology Assessment, and presented at relevant conferences. Trial registration number ISRCTN64081839; Pre-results.

A co-produced self-management programme improves psychosocial outcomes for people living with depression

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.

Maintenance antipsychotic treatment versus discontinuation strategies following remission from first episode psychosis: systematic review

Background Understanding the relative risks of maintenance treatment versus discontinuation of antipsychotics following remission in first episode psychosis (FEP) is an important area of practice. Method A 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. Results Seven 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. Conclusions There 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 interest A.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.

What does a good RCT recruitment consultation look like? A new simple six-step model to promote information sharing and recruitment to RCTs

Objective: 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. Study design and setting: 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. Results: 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. Conclusion: 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.

Treatment for femoroacetabular impingement: a qualitative method for exploring equipoise amongst hip arthroscopy surgeons

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.

Involving patients in optimising RCT participant information sheets and exploring patient acceptability of clinical trials

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.

What are the key elements of the co-production of health in clinician-patient consultations aiming to self-management support in long term health conditions?

Stress management prolongs life for CHD patients : a randomized clinical trial assessing the effects of group intervention on all cause mortality, recurrent cardiovascular disease, and quality of life