Ebenezer Afolabi

Neuropathic pain in the community: More under-treated than refractory?

Summary There is a significant proportion of chronic pain that is persistent and neuropathic, appears undertreated or untreated, and is associated with poor health and quality of life. Abstract Best current estimates of neuropathic pain prevalence come from studies using screening tools detecting pain with probable neuropathic features; the proportion experiencing significant, long‐term neuropathic pain, and the proportion not responding to standard treatment are unknown. These “refractory” cases are the most clinically important to detect, being the most severe, requiring specialist treatment. The aim of this study was to estimate the proportion of neuropathic pain in the population that is “refractory,” and to quantify associated clinical and demographic features. We posted self‐administered questionnaires to 10,000 adult patients randomly selected from 10 general practitioner practices in 5 UK locations. The questionnaire contained chronic pain identification and severity questions, cause of pain, SF‐12, EQ‐5D, S‐LANSS (Self‐administered Leeds Assessment of Neuropathic Signs and Symptoms), PSEQ (Pain Self‐Efficacy Questionnaire), use of neuropathic pain medications, and health care utilisation. These data were combined to determine the presence and characteristics of “refractory” neuropathic pain according to the defining features identified by a Delphi survey of international experts. Graded categories of chronic pain with and without neuropathic characteristics were generated, incorporating the refractory criteria. Completed questionnaires were returned by 4451 individuals (response rate 47%); 399 had “chronic pain with neuropathic characteristics” (S‐LANSS positive, 8.9% of the study sample); 215 (53.9%) also reported a positive relevant history (“Possible neuropathic pain”); and 98 (4.5% of all Chronic Pain) also reported an “adequate” trial of at least one neuropathic pain drug (“Treated possible neuropathic pain”). The most refractory cases were associated with dramatically poorer physical and mental health, lower pain self‐efficacy, higher pain intensity and pain‐related disability, and greater health care service use.

Implementing the NICE osteoarthritis guidelines: A mixed methods study and cluster randomised trial of a model osteoarthritis consultation in primary care - the Management of OsteoArthritis In Consultations (MOSAICS) study protocol

BackgroundThere is as yet no evidence on the feasibility of implementing recommendations from the National Institute of Health and Care Excellence (NICE) osteoarthritis (OA) guidelines in primary care, or of the effect these recommendations have on the condition. The primary aim of this study is to determine the clinical and cost effectiveness of a model OA consultation (MOAC), implementing the core recommendations from the NICE OA guidelines in primary care. Secondary aims are to investigate the impact, feasibility and acceptability of the MOAC intervention; to develop and evaluate a training package for management of OA by general practitioners (GPs) and practice nurses; test the feasibility of deriving `quality markers’ of OA management using a new consultation template and medical record review; and describe the uptake of core NICE OA recommendations in participants aged 45 years and over with joint pain.DesignA mixed methods study with a nested cluster randomised controlled trial.MethodThis study was developed according to a defined theoretical framework (the Whole System Informing Self-management Engagement). An overarching model (the Normalisation Process Theory) will be employed to undertake a comprehensive `whole-system’ evaluation of the processes and outcomes of implementing the MOAC intervention. The primary outcome is general physical health (Short Form-12 Physical component score [PCS]) (Ware 1996). The impact, acceptability and feasibility of the MOAC intervention at practice level will be assessed by comparing intervention and control practices using a Quality Indicators template and medical record review. Impact and acceptability of the intervention for patients will be assessed via self-completed outcome measures and semi-structured interviews. The impact, acceptability and feasibility of the MOAC intervention and training for GPs and practice nurses will be evaluated using a variety of methods including questionnaires, semi-structured interviews, and observations.DiscussionThe main output from the study will be to determine whether the MOAC intervention is clinically and cost effective. Additional outputs will be the development of the MOAC for patients consulting with joint pain in primary care, training and educational materials, and resources for patients and professionals regarding supported self-management and uptake of NICE guidance.Trial registrationISRCTN number: ISRCTN06984617.

Estimating the burden of disease in chronic pain with and without neuropathic characteristics: does the choice between the EQ-5D and SF-6D matter?

&NA; Chronic pain with neuropathic characteristics is associated with significantly lower EQ‐5D and Short Form 6D health utilities scores, with 17% reporting health states “worse than death”. &NA; The EQ‐5D and Short Form (SF)12 are widely used generic health‐related quality of life (HRQoL) questionnaires. They can be used to derive health utility index scores, on a scale where 0 is equivalent to death and 1 represents full health, with scores less than zero representing states “worse than death.” We compared EQ‐5D or SF‐6D health utility index scores in patients with no chronic pain, and chronic pain with and without neuropathic characteristics (NC), and to explore their discriminant ability for pain severity. Self‐reported health and chronic pain status was collected as part of a UK general population survey (n = 4451). We found moderate agreement between individual dimensions of EQ‐5D and SF‐6D, with most highly correlated dimensions found for mental health and anxiety/depression, role limitations and usual activities, and pain and pain/discomfort. Overall 43% reported full health on the EQ‐5D, compared with only 4.2% on the SF‐6D. There were significant differences in mean utilities for chronic pain with NC (EQ‐5D 0.47 vs SF‐6D 0.62) and especially for severe pain (EQ‐5D 0.33 vs SF‐6D 0.58). On the EQ‐5D, 17% of those with chronic pain with NC and 3% without NC scored “worse than death,” a state which is not possible using the SF‐6D. Health utilities derived from EQ‐5D and SF‐12/36 can discriminate between group differences for chronic pain with and without NC and greater pain severity. However, the instruments generate widely differing HRQoL scores for the same patient groups. The choice between using the EQ‐5D or SF‐6D matters greatly when estimating the burden of disease.

Keele Aches and Pains Study protocol: validity, acceptability, and feasibility of the Keele STarT MSK tool for subgrouping musculoskeletal patients in primary care

Musculoskeletal conditions represent a considerable burden worldwide, and are predominantly managed in primary care. Evidence suggests that many musculoskeletal conditions share similar prognostic factors. Systematically assessing patient’s prognosis and matching treatments based on prognostic subgroups (stratified care) has been shown to be both clinically effective and cost-effective. This study (Keele Aches and Pains Study) aims to refine and examine the validity of a brief questionnaire (Keele STarT MSK tool) designed to enable risk stratification of primary care patients with the five most common musculoskeletal pain presentations. We also describe the subgroups of patients, and explore the acceptability and feasibility of using the tool and how the tool is best implemented in clinical practice. The study design is mixed methods: a prospective, quantitative observational cohort study with a linked qualitative focus group and interview study. Patients who have consulted their GP or health care practitioner about a relevant musculoskeletal condition will be recruited from general practice. Participating patients will complete a baseline questionnaire (shortly after consultation), plus questionnaires 2 and 6 months later. A subsample of patients, along with participating GPs and health care practitioners, will be invited to take part in qualitative focus groups and interviews. The Keele STarT MSK tool will be refined based on face, discriminant, construct, and predictive validity at baseline and 2 months, and validated using data from 6-month follow-up. Patient and clinician perspectives about using the tool will be explored. This study will provide a validated prognostic tool (Keele STarT MSK) with established cutoff points to stratify patients with the five most common musculoskeletal presentations into low-, medium-, and high-risk subgroups. The qualitative analysis of patient and health care perspectives will inform practitioners on how to embed the tool into clinical practice using established general practice IT systems and clinician-support packages.

Does a modified STarT Back Tool predict outcome with a broader group of musculoskeletal patients than back pain? A secondary analysis of cohort data

Objectives The STarT Back Tool has good predictive performance for non-specific low back pain in primary care. We therefore aimed to investigate whether a modified STarT Back Tool predicted outcome with a broader group of musculoskeletal patients, and assessed the consequences of using existing risk-group cut-points across different pain regions. Setting Secondary analysis of prospective data from 2 cohorts: (1) outpatient musculoskeletal physiotherapy services (PhysioDirect trial n=1887) and (2) musculoskeletal primary–secondary care interface services (SAMBA study n=1082). Participants Patients with back, neck, upper limb, lower limb or multisite pain with a completed modified STarT Back Tool (baseline) and 6-month physical health outcome (Short Form 36 (SF-36)). Outcomes Area under the receiving operator curve (AUCs) tested discriminative abilities of the tools baseline score for identifying poor 6-month outcome (SF-36 lower tertile Physical Component Score). Risk-group cut-points were tested using sensitivity and specificity for identifying poor outcome using (1) Youdens J statistic and (2) a clinically determined rule that specificity should not fall below 0.7 (false-positive rate <30%). Results In PhysioDirect and SAMBA, poor 6-month physical health was 18.5% and 28.2%, respectively. Modified STarT Back Tool score AUCs for predicting outcome in back pain were 0.72 and 0.79, neck 0.82 and 0.88, upper limb 0.79 and 0.86, lower limb 0.77 and 0.83, and multisite pain 0.83 and 0.82 in PhysioDirect and SAMBA, respectively. Differences between pain region AUCs were non-significant. Optimal cut-points to discriminate low-risk and medium-risk/high-risk groups depended on pain region and clinical services. Conclusions A modified STarT Back Tool similarly predicts 6-month physical health outcome across 5 musculoskeletal pain regions. However, the use of consistent risk-group cut-points was not possible and resulted in poor sensitivity (too many with long-term disability being missed) or specificity (too many with good outcome inaccurately classified as ‘at risk’) for some pain regions. The draft tool is now being refined and validated within a new programme of research for a broader musculoskeletal population. Trial registration number ISRCTN55666618; Post results.

Implementing core NICE guidelines for osteoarthritis in primary care with a model consultation (MOSAICS): a cluster randomised controlled trial

Summary Objective To determine the effectiveness of a model osteoarthritis consultation, compared with usual care, on physical function and uptake of National Institute for Health and Care Excellence (NICE) osteoarthritis recommendations, in adults ≥45 years consulting with peripheral joint pain in UK general practice. Method Two-arm cluster-randomised controlled trial with baseline health survey. Eight general practices in England. Participants: 525 adults ≥45 years consulting for peripheral joint pain, amongst 28,443 population survey recipients. Four intervention practices delivered the model osteoarthritis consultation to patients consulting with peripheral joint pain; four control practices continued usual care. The primary clinical outcome of the trial was the SF-12 physical component score (PCS) at 6 months; the main secondary outcome was uptake of NICE core recommendations by 6 months, measured by osteoarthritis quality indicators. A Linear Mixed Model was used to analyse clinical outcome data (SF-12 PCS). Differences in quality indicator outcomes were assessed using logistic regression. Results 525 eligible participants were enrolled (mean age 67.3 years, SD 10.5; 59.6% female): 288 from intervention and 237 from control practices. There were no statistically significant differences in SF-12 PCS: mean difference at the 6-month primary endpoint was −0.37 (95% CI −2.32, 1.57). Uptake of core NICE recommendations by 6 months was statistically significantly higher in the intervention arm compared with control: e.g., increased written exercise information, 20.5% (7.9, 28.3). Conclusion Whilst uptake of core NICE recommendations was increased, there was no evidence of benefit of this intervention, as delivered in this pragmatic randomised trial, on the primary outcome of physical functioning at 6 months. Trial registration ISRCTN06984617.

Patterns of weight change after the diagnosis of type 2 diabetes in Scotland and their relationship with glycaemic control, mortality and cardiovascular outcomes: a retrospective cohort study.

Objectives To determine weight change patterns in Scottish patients 2 years after diagnosis of type 2 diabetes and to examine these in association with medium-term glycaemic, mortality and cardiovascular outcomes. Setting Using a retrospective cohort design, ethical approval was obtained to link the Scottish diabetes care database to hospital admission and mortality records. Participants 29 316 overweight/obese patients with incident diabetes diagnosed between 2002 and 2006 were identified with relevant information for ≥2 years. Primary and secondary outcome measures Weight records over time provided intrapatient weight change and variation and glycated haemoglobin (HbA1c) gave measures of glycaemic control. These characteristics and demographic variables at diagnosis were linked with notifications of death (2–5 years after diagnosis) and cardiovascular events (0–5 year after diagnosis). Results By 2 years, 36% of patients had lost ≥2.5% of their weight. Increasing age, being female and a higher body mass index at diagnosis were associated with larger proportions of weight lost (p<0.001). Multivariable modelling showed that inadequate glycaemic control at 2 years was associated with being younger at baseline, being male, having lower levels of obesity at diagnosis, gaining weight or being weight stable with weight change variability, and starting antidiabetic medication. While weight change itself was not related to mortality or cardiovascular outcomes, major weight variability was independently associated with poorer survival and increased cardiovascular outcome risks, as was deprivation. Conclusions Our results suggest that weight loss or being weight stable with little weight variability early after diabetes diagnosis, are associated with better glycaemic control and we identified groups less able to lose weight. With respect to mortality and cardiovascular outcomes, although weight change at 2 years was a weak predictor, major weight variability appeared to be the more relevant factor.

A pilot study of alcohol screening and brief interventions in community pharmacies

No randomized controlled trials (RCTs) of screening and brief intervention (SBI) have been conducted in the community pharmacy setting. This pilot study was designed to inform the development and implementation of a large-scale RCT. The study examined the feasibility of providing SBI in community pharmacies, including practical considerations, recruitment of pharmacists and clients, uptake, potential effectiveness, and acceptability. A cluster RCT was conducted involving 20 community pharmacies. Pharmacy customers were screened using the Fast Alcohol Screening Test (FAST) to determine eligibility. The control group received a general lifestyle leaflet, while the intervention group was offered BI from a trained pharmacist. Clients in both groups were asked to complete baseline and three- and six-month postal questionnaires of self-reported alcohol consumption and to re-take the FAST. Qualitative work included follow-up telephone interviews with clients as well as focus groups with the public and participating pharmacists. Over 1000 clients were approached, with 77.6% (n = 846) completing the FAST. Of these, 27.1% (n = 229) were eligible for inclusion (FAST score = 3), 69 of whom (30.1%) consented to participate (27 in the intervention group and 42 in the control group). Nearly twice the number of eligible clients were recruited from control versus intervention pharmacies (41.6% versus 21.2%). A range of barriers and facilitators were identified by participating pharmacists and clients regarding SBI delivery. The main barrier for pharmacists was approaching clients for screening. Delivery of SBI was acceptable to most pharmacists and staff, however, future success of SBI in this setting will depend on identifying strategies for supporting practitioners in engaging pharmacy clients for screening.

Management of shoulder pain by UK general practitioners (GPs): a national survey

Objectives Studies in Canada, the USA and Australia suggested low confidence among general practitioners (GPs) in diagnosing and managing shoulder pain, with frequent use of investigations. There are no comparable studies in the UK; our objective was to describe the diagnosis and management of shoulder pain by GPs in the UK. Methods A national survey of a random sample of 5000 UK GPs collected data on shoulder pain diagnosis and management using two clinical vignettes that described primary care presentations with rotator cuff tendinopathy (RCT) and adhesive capsulitis (AdhC). Results Seven hundred and fourteen (14.7%) responses were received. 56% and 83% of GPs were confident in their diagnosis of RCT and AdhC, respectively, and a wide range of investigations and management options were reported. For the RCT presentation, plain radiographs of the shoulder were most common (60%), followed by blood tests (42%) and ultrasound scans (USS) (38%). 19% of those who recommended a radiograph and 76% of those who recommended a USS did so ‘to confirm the diagnosis’. For the AdhC presentation, the most common investigations were blood tests (60%), plain shoulder radiographs (58%) and USS (31%). More than two-thirds of those recommending a USS did so ‘to confirm the diagnosis’. The most commonly recommended treatment for both presentations was physiotherapy (RCT 77%, AdhC 71%) followed by non-steroidal anti-inflammatory drugs (RCT 58%, AdhC 74%). 17% opted to refer the RCT to secondary care (most often musculoskeletal interface service), compared with 31% for the AdhC. Conclusions This survey of GPs in the UK highlights reliance on radiographs and blood tests in the management of common shoulder pain presentations. GPs report referring more than 7 out of 10 patients with RCT and AdhC to physiotherapists. These findings need to be viewed in the context of low response to the survey and, therefore, potential non-response bias.

Item response theory evaluation of the biomedical scale of the Pain Attitudes and Beliefs Scale

Objectives The assessment of health care professionals’ attitudes and beliefs towards musculoskeletal pain is essential because they are key determinants of their clinical practice behaviour. The Pain Attitudes and Beliefs Scale (PABS) biomedical scale evaluates the degree of health professionals’ biomedical orientation towards musculoskeletal pain and was never assessed using item response theory (IRT). This study aimed at assessing the psychometric performance of the 10-item biomedical scale of the PABS scale using IRT. Methods Two cross-sectional samples (BeBack, n = 1016; DABS; n = 958) of health care professionals working in the UK were analysed. Mokken scale analysis (nonparametric IRT) and common factor analysis were used to assess dimensionality of the instrument. Parametric IRT was used to assess model fit, item parameters, and local reliability (measurement precision). Results Results were largely similar in the two samples and the scale was found to be unidimensional. The graded response model showed adequate fit, covering a broad range of the measured construct in terms of item difficulty. Item 3 showed some misfit but only in the DABS sample. Some items (i.e. 7, 8 and 9) displayed remarkably higher discrimination parameters than others (4, 5 and 10). The scale showed satisfactory measurement precision (reliability > 0.70) between theta values -2 and +3. Discussion The 10-item biomedical scale of the PABS displayed adequate psychometric performance in two large samples of health care professionals, and it is suggested to assess group-level professionals degree of biomedical orientation towards musculoskeletal pain.