Patient experiences of an ankle fracture and the most important factors in their recovery : a qualitative interview study

Objective The objective of this qualitative research study is to explore patient experiences of ankle fracture and the factors most important to them in recovery. Design Semistructured interviews exploring patient experiences of ankle fracture recovery at 16–23 weeks following injury. Interviews followed a topic guide and were recorded with an encrypted audio recorder and then transcribed verbatim. Thematic content analysis was used to identify themes in the data. Setting Individuals were recruited from a sample of participants of a UK-based clinical trial of immobilisation methods for ankle fracture (ISRCTN15537280 at the pre-results stage at time of writing). Interviews were conducted at the participants’ own homes or on a university campus setting. Participants A purposive sample was used to account for key variables of age, gender and fracture management. Participants recruited from the clinical trial sample were adults aged 18 years or over with a closed ankle fracture. Results Ten participants were interviewed, five of whom were female and six of whom needed an operation to fix their ankle fracture. The age range of participants was 21–75 years with a mean of 51.6 years. Eight themes emerged from the data during analysis; mobility, loss of independence, healthcare, psychological effects, social and family life, ankle symptoms, sleep disturbance and fatigue, and activities of daily living. Factors of importance to participants included regaining their independence, sleep quality and quantity, ability to drive, ability to walk without walking aids or weight-bearing restrictions, and radiological union. Conclusions The results of this research demonstrates the extensive impact of ankle fracture on individuals’ lives, including social and family life, sleep, their sense of independence and psychological well-being. The results of this study will enable an increased understanding of the factors of relevance to individuals with ankle fracture, allowing collection of appropriate outcomes in clinical studies for this condition. Ultimately these results will help formulate appropriate patient-centred rehabilitation plans for these patients

Fidelity in complex behaviour change interventions : a standardised approach to evaluate intervention integrity

Objectives: The aim of this study was to (1) demonstrate the development and testing of tools and procedures designed to monitor and assess the integrity of a complex intervention for chronic pain (COping with persistent Pain, Effectiveness Research into Self-management (COPERS) course); and (2) make recommendations based on our experiences. Design: Fidelity assessment of a two-arm randomised controlled trial intervention, assessing the adherence and competence of the facilitators delivering the intervention. Setting: The intervention was delivered in the community in two centres in the UK: one inner city and one a mix of rural and urban locations. Participants: 403 people with chronic musculoskeletal pain were enrolled in the intervention arm and 300 attended the self-management course. Thirty lay and healthcare professionals were trained and 24 delivered the courses (2 per course). We ran 31 courses for up to 16 people per course and all were audio recorded. Interventions: The course was run over three and a half days; facilitators delivered a semistructured manualised course. Outcomes: We designed three measures to evaluate fidelity assessing adherence to the manual, competence and overall impression. Results: We evaluated a random sample of four components from each course (n=122). The evaluation forms were reliable and had good face validity. There were high levels of adherence in the delivery: overall adherence was two (maximum 2, IQR 1.67–2.00), facilitator competence exhibited more variability, and overall competence was 1.5 (maximum 2, IQR 1.25–2.00). Overall impression was three (maximum 4, IQR 2.00–3.00). Conclusions: Monitoring and assessing adherence and competence at the point of intervention delivery can be realised most efficiently by embedding the principles of fidelity measurement within the design stage of complex interventions and the training and assessment of those delivering the intervention. More work is necessary to ensure that more robust systems of fidelity evaluation accompany the growth of complex interventions

What influences graduate medical students’ beliefs of lower back pain? A mixed methods cross sectional study

Background: Low back pain (LBP) is a common condition with substantial associated disability and costs, best understood using a biopsychosocial approach. Research demonstrates that beliefs about LBP are important, with biomedical beliefs influencing practitioner’s management and patient recovery. Beliefs about LBP can be inconsistent amongst healthcare and medical students. The aim of this study was to investigate graduate medical student’s beliefs of LBP and what influences them. Method: A cross sectional mixed methods study of Phase 1 (first year) and Phase 3 (third and fourth year) current graduate medical students at the University of Warwick (MBChB) was conducted. Participants were recruited via voluntary response sampling. A survey investigated LBP beliefs, utilising the Back Beliefs Questionnaire (BBQ) and Health Care Providers’ Pain and Impairment Relationship Scale (HC-PAIRS). Qualitative data was collected on what influences beliefs about the causes and management of LBP, which was analysed descriptively using thematic analysis. Results: Fifty-seven students completed the questionnaire (61% female), with a mean age of 27.2 years. Eighty two percent of participants reported a history of LBP. Median BBQ scores were 31.5 for phase 1 and 31 for phase 3, with median HC-PAIRS scores of 57 and 60 for phase 1 and phase 3 students respectively. Three main themes emerged from the qualitative data: Sources of influence, influence of personal experience and influence of medical education. Participants discussed single or multiple sources influencing their beliefs about the causes and management of LBP. Another main theme was the influence of experiencing LBP personally or through discussions with family, friends and patients. The final main theme described the influence of medical education, including lectures, seminars and clinical placements. Conclusions: The HC-PAIRS and BBQ scores suggest graduate medical students in this sample tended to have positive beliefs about the outcome of LBP and functional expectations of chronic LBP patients, consistent with other healthcare students. The findings from qualitative data suggest how medical students form beliefs about the causes and management of LBP is complex

Primary outcome measures used in interventional trials for ankle fractures : a systematic review

Background Ankle fractures cause considerable pain, loss of function and healthcare resource use. High quality randomised controlled trials are required to evaluate the optimal management protocols for ankle fracture. However, there is debate regarding the most appropriate outcome measure to use when assessing patients with ankle fractures. The aim of this systematic review is to identify and summarise primary outcome measure use in clinical trials of non-pharmacological interventions for adults with an ankle fracture. Methods We performed comprehensive searches of the Medline, Embase, CINAHL, AMED and Cochrane CENTRAL databases, as well as ISRCTN and ClinicalTrials.gov online clinical trial registries on 19/06/2019 with no date limits applied. The titles and abstracts were initially screened to identify randomised or quasi-randomised clinical trials of non-pharmacological interventions for ankle fracture in adults. Two authors independently screened the full text of any articles which could potentially be eligible. Descriptive statistics we used to summarise the outcome measures collected in these articles including an assessment of trends over time. Secondary analysis included a descriptive summary of the multi-item patient reported outcome measures used in this study type. Results The searches returned a total of 3380 records. Following application of the eligibility criteria, 121 records were eligible for inclusion in this review. The most frequently collected primary outcome measures in this type of publication was the Olerud Molander Ankle Score, followed by radiographic and range of movement assessments. There was a total of 28 different outcome measures collected and five different multi-item, patient reported outcome measures collected as the primary outcome measure. There was a sequential increase in the number of this type of study published per decade since the 1980’s. Conclusion This review demonstrates the wide range of measurement methods used to assess outcome in adults with an ankle fracture. Future research should focus on establishing the validity and reliability of the outcome measures used in this patient population. Formulation of a consensus based core outcome set for adults with an ankle fracture would be advantageous for ensuring homogeneity across studies in order to meta-analyse trial results

Identifying potential moderators for response to treatment in low back pain : a systematic review

Background: Identifying which patients with non-specific low back pain are likely to gain the greatest benefit from different treatments is an important research priority. Few studies are large enough to produce data on sub-group effects from different treatments. Data from existing large studies may help identify potential moderators to use in future individual patient data meta-analyses. Objective: To systematically review papers of therapist delivered interventions for low back pain to identify potential moderators to inform an individual patient data meta-analysis. Data sources: We searched MEDLINE, EMBASE, Web of Science and Citation Index and Cochrane Register of Controlled Trials (CENTRALhttp://www.cochrane.org/editorial-and-publishing-policy-resource/cochrane-central-register-controlled-trials-central) for relevant papers. Data extraction and data synthesis: We screened for randomised controlled trials with ≥500 or more participants, and cohort studies of ≥1000 or more participants. We examined all publications related to these studies for any reported moderator analyses. Two reviewers independently did risk of bias assessment of main results and quality assessment of any moderator analyses. Results: We included four randomised trials (n=7208). Potential moderators with strong evidence (p<0.05) in one or more studies were age, employment status and type, back pain status, narcotic medication use, treatment expectations and education. Potential moderators with weaker evidence (0.05<p≤0.20) included gender, psychological distress, pain/disability and quality of life. Conclusion: There are insufficient robust data on moderators to be useful in clinical practice. This review has identified some important potential moderators of treatment effect worthy of testing in future confirmatory analyses

A systematic review of the measurement properties of patient reported outcome measures used for adults with an ankle fracture

Background Ankle fractures are painful and debilitating injuries that pose a significant burden to society and healthcare systems. Patient reported outcome measures (PROMs) are commonly used outcome measures in clinical trials of interventions for ankle fracture but there is little evidence on their validity and reliability. This systematic review aims to identify and appraise evidence for the measurement properties of ankle specific PROMs used in adults with an ankle fracture using Consensus Based Standards for the Selection of Health Measurement Instrument (COSMIN) methodology. Methods We searched MEDLINE, Embase and CINAHL online databases for evidence of measurement properties of ankle specific PROMs. Articles were included if they assessed or described the development of the PROM in adults with ankle fracture. Articles were ineligible if they used the PROM to assess the measurement properties of another instrument. Abstracts without full articles and conference proceedings were ineligible, as were articles that adapted the PROM under evaluation without any formal justification of the changes as part of a cross-cultural validation or translation process. Two reviewers completed the screening. To assess methodological quality we used COSMIN risk of bias checklist and summarised evidence using COSMIN quality criteria and a modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Two reviewers assessed the methodological quality and extracted the data for a sample of articles. Results The searches returned a total of 377 articles. From these, six articles were included after application of eligibility criteria. These articles evaluated three PROMs: A-FORM, OMAS and AAOS. The A-FORM had evidence of a robust development process within the patient population, however lacks post-formulation testing. The OMAS showed sufficient levels of reliability, internal consistency and construct validity. The AAOS showed low quality evidence of sufficient construct validity. Conclusions There is insufficient evidence to support the recommendation of a particular PROM for use in adult ankle fracture research based on COSMIN methodology. Further validation of these outcome measures is required in order to ensure PROMs used in this area are sufficiently valid and reliable to assess treatment effects. This would enable high quality, evidenced-based management of adults with ankle fracture

Intra-articular facet joint injections for low back pain : a systematic review

Purpose: Evidence supporting the use of therapeutic intra-articular facet joint injections for patients with suspected facet joint pain is sparse. A systematic review including a narrative synthesis was carried out to determine if intra-articular facet joint injections with active drug are more effective in reducing back pain and back pain-related disability than a sham procedure or a placebo/inactive injection. Secondly, to determine if intra-articular facet joint injections with active drug or placebo/inactive injection are more effective in reducing back pain and back pain-related disability than conservative treatment. Methods: Medline, EMBASE, CINAHL, CENTRAL, Index to Chiropractic Literature and the Cochrane Central Register of Controlled Trials were searched from inception through April 2015. Data were screened and single extraction with independent verification and risk of bias assessment was performed. Results: A total of 391 records were screened, and six trials were included. The trials included were small (range 18–109 participants) and overall in terms of pain and disability outcomes most were inconclusive. Only two of the trials report any significant between-group differences in pain (mean difference −1.0, 95 % CI −2.0 to −0.1) and (p = 0.032) or disability (mean difference −3.0, 95 % CI −6.2 to 0.2) and (p = 0.013) outcomes. Conclusions: The studies found here were clinically diverse and precluded any meta-analysis. A number of methodological issues were identified. The positive results, whilst interpreted with caution, do suggest that there is a need for further high-quality work in this area

Implementing a hybrid cognitive-behavioural therapy for pain-related insomnia in primary care : lessons learnt from a mixed-methods feasibility study

Objectives: To test the feasibility of implementing a brief but intensive hybrid cognitive behavioural therapy (Hybrid CBT) for pain-related insomnia. Design: Mixed-methods, with qualitative process evaluation on a two-arm randomised controlled feasibility trial. Setting: Primary care. Participants: Twenty-five adult patients with chronic pain and insomnia. Intervention: Hybrid CBT or self-help control intervention. Primary and secondary outcome measures: Primary outcomes measures were the Insomnia Severity Index and interference scale of the Brief Pain Inventory (BPI). Secondary outcomes measures were the present pain intensity rating from the BPI, Multidimensional Fatigue Inventory, Hospital Anxiety and Depression Scale and EQ-5D-5L. Results: Fourteen participants were randomised to receive Hybrid CBT, 11 to receive the self-help control treatment. Of the 14 in the Hybrid CBT group, 9 (64%) completed all four treatment sessions (4 discontinued due to poor health; 1 due to time constraints). Adherence to the self-help control treatment was not monitored. The total number of participants completing the 12-week and 24-week follow-ups were 12 (6 in each group; Hybrid CBT: 43%; self-help: 55%) and 10 (5 in each group; Hybrid CBT: 36%; self-help: 45%). Based on the data available, candidate outcome measures appeared to be sensitive to changes associated with interventions. Thematic analysis of pre-postintervention interview data revealed satisfaction with treatment content among those who completed the Hybrid CBT, whereas those in the self-help control treatment wanted more contact hours and therapist guidance. Other practical suggestions for improvement included shortening the duration of each treatment session, reducing the amount of assessment paperwork, and minimising the burden of sleep and pain monitoring. Conclusion: Important lessons were learnt with regard to the infrastructure required to achieve better patient adherence and retention. Based on the qualitative feedback provided by a subset of treatment completers, future trials should also consider lowering the intensity of treatment and streamlining the data collection procedure. Trial registration number: ISRCTN17294365

A patient satisfaction survey investigating pre- and post-operative information provision in lower limb surgery

Background Planned lower limb surgery is common, with over 90,000 hip replacements, 95,000 knee replacements and 15,000 anterior cruciate ligament reconstructions performed in the UK each year. These procedures are primarily indicated to treat osteoarthritis, sporting injuries and trauma. Patient satisfaction is an important element of healthcare provision, which is usually measured by functional outcomes but influenced by other factors. Few studies have assessed patients’ views on the information given to them pertaining surgery and patients are infrequently consulted when designing leaflets and information packs, which can lead to confusion during the recovery period and poor long-term outcomes. Furthermore, previous studies have not directly asked patients what resources they would prefer, or which format would suit them best. This project aimed to assess if patients were satisfied with the information they received around their operations and to identify potential improvements. Methods Set in a National Health Service (NHS) run major trauma centre in the West Midlands, a multiple choice and free-text answer survey was administered to patients who used the orthopaedic service over the course of 1 month. Surveys were designed in Qualtrics and administered face-to-face on paper. Thematic content analysis was performed on the results. Results Eighty patients completed the survey, of which 88.8% of patients were satisfied with the information they received. Discussions with surgeons were the most useful resource and 53% of patients requested more internet resources. Post-operative patients were statistically more likely to be dissatisfied with information provision than pre-operative patients. Over 20% of the study population requested more information on post-operative pain and recovery timelines. Conclusions Although patients were satisfied in general, areas for change were identified. Suggested resources took the form of webpages and mobile platforms. These resources could contain educational videos, patient experience blogs or interactive recovery timelines, to be of benefit to patients. These suggestions may enable NHS Trusts to “get into the digital age”, however, more research on patient satisfaction around information provision and the impact it has on recovery and decision making is needed