Sarah Hewlett

Persistent pain after joint replacement: Prevalence, sensory qualities, and postoperative determinants

&NA; Persistent postsurgical pain is a prevalent but underacknowledged condition. The aim of this study was to assess the prevalence, sensory qualities, and postoperative determinants of persistent pain at 3 to 4 years after total knee replacement (TKR) and total hip replacement (THR). Patients completed a questionnaire with included the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Scale, PainDetect Questionnaire, Short‐Form McGill Pain Questionnaire, and questions about general health and socioeconomic status. A total of 632 TKR patients and 662 THR patients completed a questionnaire (response rate of 73%); 44% of TKR patients and 27% of THR patients reported experiencing persistent postsurgical pain of any severity, with 15% of TKR patients and 6% of THR patients reporting severe‐extreme persistent pain. The persistent pain was most commonly described as aching, tender, and tiring, and only 6% of TKR patients and 1% of THR patients reported pain that was neuropathic in nature. Major depression and the number of pain problems elsewhere were found to be significant and independent postoperative determinants of persistent postsurgical pain. In conclusion, this study found that persistent postsurgical pain is common after joint replacement, although much of the pain is mild, infrequent, or an improvement on preoperative pain. The association between the number of pain problems elsewhere and the severity of persistent postsurgical pain suggests that patients with persistent postsurgical pain may have an underlying vulnerability to pain. A small percentage of patients have severe persistent pain after joint replacement, and this is associated with depression and the number of pain problems elsewhere.

Return to sport after joint replacement

Our aim was to determine the pre-operative sporting profiles of patients undergoing primary joint replacement and to establish if they were able to return to sport after surgery. A postal survey was completed by 2085 patients between one and three years after operation. They had undergone one of five operations, namely total hip replacement, hip resurfacing, total knee replacement, unicompartmental knee replacement or patellar resurfacing. In the three years before operation 726 (34.8%) patients were participating in sport, the most common being swimming, walking and golf. A total of 446 (61.4%) had returned to their sporting activities by one to three years after operation and 192 (26.4%) were unable to do so because of their joint replacement, with the most common reason being pain. The largest decline was in high-impact sports including badminton, tennis and dancing. After controlling for the influence of age and gender, there was no significant difference in the rate of return to sport according to the type of operation.

European League Against Rheumatism recommendations for the inclusion of patient representatives in scientific projects

Objective To develop recommendations to enable successful inclusion of the patient perspective in European League Against Rheumatism (EULAR)-funded scientific research projects. Methods The EULAR standardised operational procedures for guideline development were followed. A systematic literature review was presented during a first task force meeting, including 3 rheumatologists, 1 rheumatologist/epidemiologist, 2 allied health professionals, 2 representatives of arthritis research organisations and 7 patient representatives, resulting in 38 statements. A Delphi method was carried out to reduce and refine the statements and agree on a set of eight. Next, a survey among a wider group of experts, professionals and patient representatives (n=42), was completed. Feedback from this wider group was discussed at the second meeting and integrated in the final wording of the recommendations. Subsequently, the level of agreement of the group of experts (n=81) was re-evaluated. Results The project resulted in a definition of patient research partner and agreement on a set of eight recommendations for their involvement in research projects. These recommendations provide practical guidance for organising patient participation, capturing (1) the role of patient research partners, (2) phase of involvement, (3) the recommended number, (4) recruitment, (5) selection, (6) support, (7) training and (8) acknowledgement. Conclusion Collaboration between patients and professionals in research is relatively new. Trials or effectiveness studies are not yet available. Nevertheless, it is possible to define recommendations for the inclusion of patients in research following a solid expert opinion based consensus process.

Self-management of fatigue in rheumatoid arthritis: a randomised controlled trial of group cognitive-behavioural therapy

Objectives To investigate the effect of group cognitive behavioural therapy (CBT) for fatigue self-management, compared with groups receiving fatigue information alone, on fatigue impact among people with rheumatoid arthritis (RA). Methods Two-arm, parallel randomised controlled trial in adults with RA, fatigue ≥6/10 (Visual Analogue Scale (VAS) 0–10, high bad) and no recent change in RA medication. Group CBT for fatigue self-management comprised six (weekly) 2 h sessions, and consolidation session (week 14). Control participants received fatigue self-management information in a 1 h didactic group session. Primary outcome at 18 weeks was the impact of fatigue measured using two methods (Multi-dimensional Assessment of Fatigue (MAF) 0–50; VAS 0–10), analysed using intention-to-treat analysis of covariance with multivariable regression models. Results Of 168 participants randomised, 41 withdrew before entry and 127 participated. There were no major baseline differences between the 65 CBT and 62 control participants. At 18 weeks CBT participants reported better scores than control participants for fatigue impact: MAF 28.99 versus 23.99 (adjusted difference −5.48, 95% CI −9.50 to −1.46, p=0.008); VAS 5.99 versus 4.26 (adjusted difference −1.95, 95% CI −2.99 to −0.90, p<0.001). Standardised effect sizes for fatigue impact were MAF 0.59 (95% CI 0.15 to 1.03) and VAS 0.77 (95% CI 0.33 to 1.21), both in favour of CBT. Secondary outcomes of perceived fatigue severity, coping, disability, depression, helplessness, self-efficacy and sleep were also better in CBT participants. Conclusions Group CBT for fatigue self-management in RA improves fatigue impact, coping and perceived severity, and well-being. Trial registration: ISRCTN 32195100

Fatigue in rheumatoid arthritis: time for a conceptual model

In recent years, formal collaboration with RA patients has explored what treatment outcomes are important to them. Patients repeatedly raise concerns about the major impact of RA fatigue. Qualitative research, replicated internationally, shows that patients with RA experience fatigue as uncontrollable and overwhelming yet find it largely ignored by clinicians [1]. Fatigue is highly prevalent in RA (up to 70% of patients), is as severe and frequent as pain [2] and is consistently prioritized by patients within their top outcome priorities, often as high or higher than pain [3]. Fatigue data also provide information about disease activity that is additional to that measured by the current ACR core set variables [4]. All these findings led to an international consensus at OMERACT in 2006 that fatigue should be measured in all clinical trials in addition to the core set [4]. Fatigue measurement is now recommended for other core data sets in Europe [RA Impact of Disease (RAID)], the UK [RA Patient Priorities for Pharmacological Interventions (RAPP-PI)] and the USA (ACR/EULAR recommendation for assessing remission). However, evidence on the causality of fatigue in RA is conflicting and derived mainly from cross-sectional studies using generic or less-robust fatigue patient-reported outcome measures [5]. In order to clarify which research questions will be most informative in identifying causal pathways for fatigue in RA, and to develop potential interventions, a conceptual framework of RA fatigue is now essential. We propose a conceptual model for RA fatigue (Fig. 1) that suggests interactions between three factors: disease processes (RA), thoughts, feelings and behaviours (cognitive, behavioural) and personal life issues (personal). RA disease factors (Fig. 1) that might drive fatigue include de-conditioning and actual or perceived increased muscle effort (resulting from joint damage, disability and reduced physical activity), anaemia, RA medication and sleep that is disturbed by RA pain [1, 5]. Joint damage, disability and pain emanate from the inflammatory processes of RA. Inflammatory processes may be associated with an abnormal cortisol response via the hypothalamic pituitary adrenal (HPA) axis [6], which might explain the sudden, dramatic and unpredictable wipe-out episodes reported by many RA patients [1]. The cognitive and behavioural factor (Fig. 1) is a recognized dynamic model that demonstrates interactions between thoughts (e.g. I should be able to do all the activities I used to do), feelings (e.g. sad that I am struggling to keep up activities), behaviours (e.g. keep going until I finish this activity) and symptoms (I kept going until completely wiped out with fatigue) [7]. RA studies show that illness beliefs that RA has serious consequences, low self-efficacy and low mood all predict future RA fatigue [8]. Behavioural issues such as persisting with prolonged physical activity until exhaustion supervenes (boom and bust) or resting excessively may also influence fatigue. Personal factors that potentially influence RA fatigue (Fig. 1) include personal responsibilities that are important for an individual (e.g. going to work to earn income, caring for family members), unhelpful personal environments (e.g. stairs, lack of assistive devices) and social support that is either unhelpful or has been lost. Health issues such as comorbidities (e.g. diabetes, cardiac disease), dietary patterns (poor nutrition, gaps between meals) and age or gender, may be influential. These variables may either predispose to fatigue (e.g. diagnosis of RA), precipitate a specific fatigue episode (e.g. a poor night’s sleep) [5] or perpetuate existing fatigue (e.g. accepting social invitations despite knowing you are too fatigued). However, many may do all three—for example, previous depression predisposes to future RA fatigue and current depression is related to or precipitates current fatigue [5], but depression may also affect behaviours that perpetuate fatigue (e.g. withdrawal from physical activities, leading to de-conditioning). Our proposed model is therefore dynamic, with bi-directional arrows suggesting inter-relationships between and within the three factors (RA, cognitions and behaviours, and personal). For example, it is clear that the thoughts, behaviours and emotions associated with fatigue are related (at least in part) to the consequences of having RA in the first place, and all elements must be set within the context of personal life (e.g. an inflammatory flare is fatiguing because an individual has to work to provide an income, and cannot accept fatigue as a valid reason to take sick leave). There are few published trials that specifically aimed to improve RA fatigue. However, some interventions that are primarily aimed at improving other variables in the model, also reduce fatigue: pharmacological interventions to reduce inflammation, exercise interventions to improve physical activity and cognitive behavioural therapy (CBT)

Measuring Fatigue in Rheumatoid Arthritis: A Cross-Sectional Study to Evaluate the Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire, Visual Analog Scales, and Numerical Rating Scales

Current patient‐reported outcome measures of fatigue in rheumatoid arthritis (RA) have limitations, providing only a global perspective. This study constructed a questionnaire (the Bristol RA Fatigue Multi‐Dimensional Questionnaire [BRAF‐MDQ]) from 45 preliminary questions derived from analysis of patient interviews and surveys and explored its structure for fatigue dimensions. The BRAF‐MDQ and short BRAF numerical rating scales (NRS) and visual analog scales (VAS) for severity, effect, and ability to cope with fatigue were evaluated for validity.

Patient initiated outpatient follow up in rheumatoid arthritis: six year randomised controlled trial.

Abstract Objectives To determine whether direct access to hospital review initiated by patients with rheumatoid arthritis would result in improved clinical and psychological outcome, reduced overall use of healthcare resources, and greater satisfaction with care than seen in patients receiving regular review initiated by a rheumatologist. Design Two year randomised controlled trial extended to six years. Setting Rheumatology outpatient department in teaching hospital. Participants 209 consecutive patients with rheumatoid arthritis for over two years; 68 (65%) in the direct access group and 52 (50%) in the control group completed the study (P = 0.04). Main outcome measures Clinical outcome: pain, disease activity, early morning stiffness, inflammatory indices, disability, grip strength, range of movement in joints, and bone erosion. Psychological status: anxiety, depression, helplessness, self efficacy, satisfaction, and confidence in the system. Number of visits to hospital physician and general practitioner for arthritis. Results Participants were well matched at baseline. After six years there was only one significant difference between the two groups for the 14 clinical outcomes measured (deterioration in range of movement in elbow was less in direct access patients). There were no significant differences between groups for median change in psychological status. Satisfaction and confidence in the system were significantly higher in the direct access group at two, four, and six years: confidence 9.8 v 8.4, 9.4 v 8.0, 8.7 v 6.9; satisfaction 9.3 v 8.3, 9.3 v 7.7, 8.9 v 7.1 (all P < 0.02). Patients in the direct access group had 38% fewer hospital appointments (median 8 v 13, P < 0.0001). Conclusions Over six years, patients with rheumatoid arthritis who initiated their reviews through direct access were clinically and psychologically at least as well as patients having traditional reviews initiated by a physician. They requested fewer appointments, found direct access more acceptable, and had more than a third fewer medical appointments. This radical responsive management could be tested in other chronic diseases.

Identifying core domains to assess flare in rheumatoid arthritis: an OMERACT international patient and provider combined Delphi consensus

Objective For rheumatoid arthritis (RA), there is no consensus on how to define and assess flare. Variability in flare definitions impairs understanding of findings across studies and limits ability to pool results. The OMERACT RA Flare Group sought to identify domains to define RA flares from patient and healthcare professional (HCP) perspectives. Methods Flare was described as a worsening of disease activity of sufficient intensity and duration to consider a change in therapy. International patients and HCPs participated in separate and combined rounds of Delphi exercises to rate candidate flare domains previously generated in patient focus groups. Core domains were defined as those with ≥70% ratings of being ‘essential’ according to the third/final Delphi exercise. Results The final Delphi included 125 RA patients from 10 countries and 108 HCPs from 23 countries who rated 14 domains. Patients had a mean (±SD) age of 56±12 years and disease duration of 18±12 years. HCPs included physicians from clinical practice/research and industry, allied health providers and researchers with 17±11 years experience. Core domains comprised: pain (93%), function (89%), swollen joints (84%), tender joints (81%), participation (81%), stiffness (79%), patient global assessment (76%) and self-management (75%). Fatigue (68%), which did not reach group consensus, will receive additional consideration. Conclusions As part of the process to develop a measure for RA flare, patients and HCPs agreed on eight core domains. Next steps include identifying items to assess domains and conducting studies to validate and refine a new measure.

Developing a Standardized Definition for Disease “Flare” in Rheumatoid Arthritis (OMERACT 9 Special Interest Group)

Objective. Traditional outcome measures in randomized controlled trials (RCT) include well-established response criteria as well as ACR EULAR responses using Disease Activity Score 44 (DAS44)/DAS28 to assess improvement; however, a measure to assess worsening of disease has yet to be developed. This special interest group (SIG) was established to develop an evidence-based, consensus-driven standard definition of “flare” in rheumatoid arthritis (RA). Methods. At OMERACT 8, the need for a standardized definition of RA flare was recognized; interested individuals developed a proposal to form a SIG. A literature review was performed to identify publications and abstracts with flare definitions applied in RA, JIA, and lupus RCT as well as concerning patient perspectives on disease worsening. A SIG was held at OMERACT 9 with breakout sessions for patients and investigators. Results. The RA flare SIG was attended by about 120 participants, including 11 patients. Patients and investigators held separate breakout sessions to discuss various aspects of disease worsening. The following consensus was obtained at OMERACT 9: a working definition of flare should indicate worsening of disease activity (88%), persistence, and duration as critical elements (77%), and consideration of change or increase in therapy (74%). Conclusion. A working definition of RA flare was developed based on these votes: flare is any worsening of disease activity that would, if persistent, in most cases lead to initiation or change of therapy; and a flare represents a cluster of symptoms of sufficient duration and intensity to require initiation, change, or increase in therapy. Using this working definition, evaluation of candidate domains will be conducted via Delphi exercise and further informed by patient focus groups. Validation of candidate definitions in appropriate RCT will be required.

Collaboration with patients in the design of patient reported outcome measures: Capturing the experience of fatigue in rheumatoid arthritis

Patient‐reported outcome measures (PROMs) need to include concepts and language relevant to patients and be easily understood. These studies aimed to develop draft PROMs to measure rheumatoid arthritis (RA) fatigue and its impact by collaborating with patients to identify language and experiences, create draft PROM items, and test them for comprehension, with decisions supported throughout by a patient research partner.