Effect of anti-TNF and conventional synthetic disease-modifying anti-rheumatic drug treatment on work disability and clinical outcome in a multicentre observational cohort study of psoriatic arthritis.

Objectives: To determine the effect of medical treatment on work disability in patients with active PsA in a real-world setting. Methods: Four hundred patients with active PsA commencing or switching to anti-TNF or conventional synthetic DMARD (csDMARD) were recruited to a multicentre UK prospective observational cohort study. Work disability was measured using the work productivity and activity-specific health problem instrument and peripheral joint activity was measured with the disease activity in PsA composite measure. Results: Four hundred patients were recruited, of whom 229 (57.25%) were working (of any age). Sixty-two patients of working age (24%) were unemployed. At 6 months there was a 10% improvement in presenteeism ( P = 0.007) and a 15% improvement in work productivity ( P = 0.001) among working patients commenced on csDMARDs ( n = 164) vs a larger and more rapid 30% improvement in presenteeism ( P < 0.001) and 40% improvement in work productivity ( P < 0.001) among those commenced on anti-TNF therapy ( n = 65). Clinical response was poor among patients commenced on a csDMARD ( n = 272), with an 8.4 point improvement in disease activity in PsA ( P < 0.001) vs those commenced on anti-TNF therapy ( n = 121), who had a 36.8 point improvement ( P < 0.001). Conclusion: We report significant and clinically meaningful improvements in both work disability and clinical outcomes after commencement of anti-TNF therapy in a real-world setting. Improvements in all outcomes among those commencing csDMARDs were slower and of a smaller magnitude.

"Engaging with birth stories in pregnancy: a hermeneutic phenomenological study of women's experiences across two generations".

BACKGROUND: The birth story has been widely understood as a crucial source of knowledge about childbirth. What has not been reported is the effect that birth stories may have on primigravid women's understandings of birth. Findings are presented from a qualitative study exploring how two generations of women came to understand birth in the milieu of other's stories. The prior assumption was that birth stories must surely have a positive or negative influence on listeners, steering them towards either medical or midwifery-led models of care. METHODS: A Heideggerian hermeneutic phenomenological approach was used. Twenty UK participants were purposively selected and interviewed. Findings from the initial sample of 10 women who were pregnant in 2012 indicated that virtual media was a primary source of birth stories. This led to recruitment of a second sample of 10 women who gave birth in the 1970s-1980s, to determine whether they were more able to translate information into knowledge via stories told through personal contact and not through virtual technologies. RESULTS: Findings revealed the experience of 'being-in-the-world' of birth and of stories in that world. From a Heideggerian perspective, the birth story was constructed through 'idle talk' (the taken for granted assumptions of things, which come into being through language). Both oral stories and those told through technology were described as the 'modern birth story'. The first theme 'Stories are difficult like that', examines the birth story as problematic and considers how stories shape meaning. The second 'It's a generational thing', considers how women from two generations came to understand what their experience might be. The third 'Birth in the twilight of certainty,' examines women's experience of Being in a system of birth as constructed, portrayed and sustained in the stories being shared. CONCLUSIONS: The women pregnant in 2012 framed their expectations in the language of choice, whilst the women who birthed in the 1970s-1980s framed their experience in the language of safety. For both, however, the world of birth was the same; saturated with, and only legitimised by the birth of a healthy baby. Rather than creating meaningful understanding, the 'idle talk' of birth made both cohorts fearful of leaving the relative comfort of the 'system', and of claiming an alternative birth.

Studying for a doctorate: developing a strong voice.

Studying for a doctoral degree can be an exciting, invigorating and ultimately satisfying process but equally it can be a long, arduous, frustrating and lonely journey. In this article I speak of my own experience of the process and offer some thoughts about the 'what, why, when and how' of studying at this level. I consider the excitement of developing your own ideas and project alongside the challenges inherent in doctoral level study, such as coping with uncertainty and rarely having a sense of closure, and I offer some practical challenges to help you decide whether doctoral study is for you.

Young people's decisions about biologic therapies: who influences them and how?

OBJECTIVES: Young people with inflammatory arthritis can have severe disease warranting biologic therapy. They face complex treatment decisions, with profound consequences. This study aimed to explore the influence of individuals outside the care team (trusted others) on the treatment decisions made by young people, in particular their decisions about biologic therapies. METHODS: Young people (16-25 years of age) with inflammatory arthritis and experience of treatment decision making were recruited from three NHS Hospital Trusts. Twenty-five were interviewed, plus 11 trusted others identified by young people as being involved in their decision making, as well as 6 health professionals. The data were analysed using coding, memoing and mapping techniques and the findings were tested through a series of focus groups. RESULTS: Young people initially emphasized their decisional autonomy, typically describing people other than health professionals as limited in influence. However, discussions revealed the involvement--in deliberation and enactment--of a range of other people. This cast of trusted others was small and largely consistent; mothers played a particularly prominent role, providing cognitive, practical and emotional support. Members of the wider cast of trusted others were involved in more limited but still significant ways. CONCLUSION: Young people claim autonomy but other people enable this. The network of relationships in which they are embedded is distinctive and evolving. Mothers play a supporting role well into early adulthood; in contrast, partners are involved in far more limited ways. As such, the applicability of adult models of decision making is unclear. This must be taken into account if the support provided by professionals is to be optimally tailored to young people's needs.

Factors influencing work disability in psoriatic arthritis: first results from a large UK multicentre study.

OBJECTIVE: The aim of this study was to determine the extent to which structural damage, clinical disease activity, demographic and social factors are associated with work disability (WD) in PsA. METHODS: Four hundred patients fulfilling CASPAR (Classification Criteria for Psoriatic Arthritis) criteria for PsA were recruited from 23 hospitals across the UK. Demographic, socio-economic, work, clinical and radiographic data were collected. WD was assessed with the Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) questionnaire reporting WD as a percentage of absenteeism (work time missed), presenteeism (impairment at work/reduced effectiveness) and work productivity loss (overall work impairment/absenteeism plus presenteeism). Logistic and linear regressions were conducted to investigate associations with WD. RESULTS: Two hundred and thirty-six participants of any age were in work. Absenteeism, presenteeism and productivity loss rates were 14% (s.d. 29.0), 39% (s.d. 27.2) and 46% (s.d. 30.4), respectively. Ninety-two (26%) participants of working age were unemployed. Greater age, disease duration of 2-5 years and worse physical function were associated with unemployment. Patients reported that employer awareness and helpfulness exerted a strongly positive influence on remaining in employment. Higher levels of global and joint-specific disease activity and worse physical function were associated with greater levels of presenteeism and productivity loss among those who remained in work. CONCLUSION: Reduced effectiveness at work was associated with measures of disease activity, whereas unemployment, considered the endpoint of WD, was associated with employer factors, age and disease duration. A longitudinal study is under way to determine whether treatment to reduce disease activity ameliorates WD in the real-world setting.

The British Society for Rheumatology Biologics Registers in Ankylosing Spondylitis (BSRBR-AS) study: Protocol for a prospective cohort study of the long-term safety and quality of life outcomes of biologic treatment.

BACKGROUND: Axial spondyloarthropathy typically has its onset in early adulthood and can impact significantly on quality of life. In the UK, biologic anti-tumour necrosis factor therapy is recommended for patients who are unresponsive to non-steroidal anti-inflammatory drugs. There remain several unresolved issues about the long-term safety and quality of life outcomes of biologic treatment in axial spondyloarthropathy. Long-term "real-world" surveillance data are required to complement data from randomised controlled trials. METHODS/DESIGN: We are conducting a UK-wide prospective cohort study of patients with axial spondyloarthropathy who are naïve to biologic therapy at the time of recruitment. Those about to commence anti-tumour necrosis factor biologic therapy will enter a "biologic" sub-cohort with other patients assigned to a "non-biologic" sub-cohort. The primary objective is to determine whether the use of biologic therapy is associated with an increased risk of serious infection, while secondary objectives are to assess differences in malignancy, serious comorbidity, all-cause mortality but also assess impact on specific clinical domains (physical health, mental health and quality of life) including work outcomes between biologic and non-biologic patient cohorts. Patients will be followed-up for up to 5 years. Data are obtained at baseline and at standard clinical follow-up visits - at 3, 6 and 12 months and then annually for the biologic cohort and annually for the non-biologic cohort. This study will also collect biological samples for genetic analysis. DISCUSSION: Although biologic therapy is widely used for ankylosing spondylitis patients who are unresponsive to non-steroidal anti-inflammatory drugs, the majority of the available safety information comes from rheumatoid arthritis, where increased infection risk has consistently been shown. However, given the typical demographic differences between rheumatoid arthritis and axial spondyloarthropathy patients, it is important to develop an epidemiologically rigorous cohort of patients receiving biologic therapy to effectively evaluate outcomes with regard not only to safety but also to quantify benefits across clinical, psychosocial and work outcomes. CLINICAL TRIAL REGISTRATION: This is an observational cohort study and clinical trial registration was not required or obtained.

Rheumatology and rheumatoid arthritis in the twenty-first century.

Rheumatoid arthritis (RA) has historically been a disabling and life-threatening disease. Features include joint pain, stiffness and swelling, joint damage, fatigue, loss of function, and loss of employment. Recent advances in treatment, particularly the use of conventional disease-modifying therapies earlier and in combination, and the advent of biological therapies, ensures that modern rheumatologists expect to help patient attain remission, with advantages of early presentation and effective therapies used in a "treatment to target" strategy. Adherence to UK National Institute for Health and Clinical Excellence guidance for RA, including early identification of disease, early and aggressive use of disease-modifying antirheumatic therapies, in combination or with biological agents, allows for much better disease control and perhaps remission. Delays to diagnosis will therefore become increasingly important, and the necessity for accurate diagnosis becomes crucial. The strategy of tight disease control may be more important than the contribution of individual drugs, even biological agents. Future prospects include the use of better outcome measures to define remission, better prediction of outcome, and thus better targeting of therapies. There is an urgent need for better individualized prognostic predictors. We must not forget the management of patients with pain owing to damage from advanced disease. Rheumatologists and radiologists must work together to appreciate the opportunities for patients from a greater understanding of disease measurement.

Assessing and implementing approved assessment procedures.

In this reflection I share my experience of designing and implementing an assessment for a level three midwifery module. By sharing my experience I hope to give others an insight into the process, including the challenge of ensuring that any examination is robust enough to meet the needs of the assessment. Designing a robust assessment is crucial as ultimately any assessment on a midwifery pathway is influential in developing safe and competent midwives.

Participation in and a critical review of educational audit.

In this reflection I discuss my first engagement with the educational audit process. Audit of the environment is a crucial element in the education of student midwives; educational audit is complex as placement areas are dynamic, fast-changing environments. It is important for all involved parties to recognise that the quality of the learning experience is far more reliant on the 'virtual environment' provided by quality mentors rather than on the more concrete practice setting.

Systems-based investigation of patient safety incidents.

Patient safety events are common in healthcare. We can learn from other safety-critical industries that further incidents are most likely to be prevented where lessons are learned at the system level rather than looking to attribute blame for errors to individuals. Progress has been made over the last 20 years and relies on a positive safety culture (or just culture) where staff trust organisations to investigate safety events for learning rather than blame. Systems-based investigation models, such as the Systems Engineering Initiative for Patient Safety (SEIPS), help investigators to consider the full range of contributory factors across a system and to identify important findings. Considering the hierarchy of controls, recommendations should be targeted at system changes which are more likely to produce sustained safety improvements, rather than at individual behaviours or training, which are less likely to influence future safety. Systems-based safety investigations can positively influence safety culture in organisations.

Spirituality and childbirth: An international virtual co-operative inquiry.

PROBLEM: Medicalised maternity systems do not address spirituality as an aspect of childbirth and its practices of care. Neglecting the spiritual nature of childbirth may negatively affect psychological, emotional and physical wellbeing. BACKGROUND: While there is growing interest in the spiritual side of childbirth there is a paucity of literature on the topic, and hence a lack of understanding generally about how to attend to women's needs for emotional and spiritual support in childbirth. AIM: To collaboratively and through consensus explore ways that spirituality could be honoured in 2st Century maternity care. METHODS: An online co-operative inquiry. Starting with a scoping exercise (N=17) nine co-inquirers continued to Phase One using online discussion boards and seven co-inquirers continued to Phase Two and Three. Co-inquirers were involved in international group work and individual reflective and transformational processes throughout. FINDINGS: Four reflective themes emerged: 'meaning and sense-making'; 'birth culture'; 'embodied relationships and intuition'; and 'space/place/time'. 'Spiritual midwifing' was an overarching theme. There were eight areas of individual transformation and actions concerning spirituality and birth: 1) disseminating inquiry findings; 2) motivating conversations and new ways of thinking; 3) remembering interconnectedness across time and spaces; 4) transforming relationships; 5) transforming practice; 6) generating reflexivity; 7) inspiring self and others to change, and 8) inspiring creativity. CONCLUSION: Spiritual awareness around birth experience emerges through relationships and is affected by the spatial environment. Spiritual midwifing is a relational approach to birth care that recognises and honours the existential significance and meaningfulness of childbirth.

National Early Warning Score 2 (NEWS2) to identify inpatient COVID-19 deterioration: a retrospective analysis.

INTRODUCTION: We sought to provide the first report of the use of NEWS2 monitoring to pre-emptively identify clinical deterioration within hospitalised COVID-19 patients. METHODS: Consecutive adult admissions with PCR-confirmed COVID-19 were included in this single-centre retrospective UK cohort study. We analysed all electronic clinical observations recorded within 28 days of admission until discharge or occurrence of a serious event, defined as any of the following: initiation of respiratory support, admission to intensive care, initiation of end of life care, or in-hospital death. RESULTS: 133/296 (44.9%) patients experienced at least one serious event. NEWS2 ≥ 5 heralded the first occurrence of a serious event with sensitivity 0.98 (95% CI 0.96-1.00), specificity 0.28 (0.21-0.35), positive predictive value (PPV) 0.53 (0.47-0.59), and negative predictive value (NPV) 0.96 (0.90-1.00). The NPV (but not PPV) of NEWS2 monitoring exceeded that of other early warning scores including the Modified Early Warning Score (MEWS) (0.59 [0.52-0.66], p<0.001) and quick Sepsis Related Organ Failure Assessment (qSOFA) score (0.58 [0.51-0.65], p<0.001). CONCLUSION: Our results support the use of NEWS2 monitoring as a sensitive method to identify deterioration of hospitalised COVID-19 patients, albeit at the expense of a relatively high false-trigger rate.

Feasibility, acceptability and change in health following a telephone-based cognitive behaviour therapy intervention for patients with axial spondyloarthritis.

OBJECTIVE: The aim was to assess the feasibility and acceptability of a telephone-based cognitive behaviour therapy (tCBT) intervention for individuals with axial SpA (axSpA), with and without co-morbid FM, and to measure the change in patient-reported health outcomes. METHODS: A convenience sample of individuals recruited from British Society for Rheumatology Biologics Registry for AS (BSRBR-AS) sites were offered a course of tCBT (framed as coaching). Patient-reported outcomes were measured at baseline and on course completion. Semi-structured qualitative interviews assessed intervention acceptability. Thematic analysis was informed by the theoretical framework of acceptability. RESULTS: Forty-two participants attended for initial assessment. Those completing at least one tCBT session (n = 28) were younger, more likely to meet classification criteria for FM (57 vs 29%) and reported higher disease activity. Modest improvements were reported across a range of disease activity and wider health measures, with 62% of patients self-rating their health as improved (median 13 weeks post-intervention). Twenty-six participants were interviewed (including six who discontinued after initial assessment). tCBT was widely acceptable, offering a personalized approach. Despite low or unclear expectations, participants described improved sleep and psychological well-being and gained new skills to support self-management. Reasons for non-uptake of tCBT centred on lack of perceived need and fit with individual value systems. Many felt that tCBT would be most useful closer to diagnosis. CONCLUSION: Higher uptake among axSpA patients with co-morbid FM suggests that these individuals have additional needs. The findings are helpful in identifying patients most likely to engage with and benefit from tCBT and to maximize participation.

The BSR-PsA: study protocol for the British Society for Rheumatology psoriatic arthritis register.

BACKGROUND: Psoriatic arthritis (PsA) presents a unique clinical challenge. Affecting joints, skin, nails, and other organs, it is associated with various comorbidities and has a significant impact on quality of life, social participation and working life. While biologic and other targeted synthetic disease modifying anti-rheumatic drugs (bDMARDs and tsDMARDs) have revolutionised therapy, questions remain about the long-term safety of these agents, and their effectiveness and cost-effectiveness in the real-world clinical setting. METHODS/DESIGN: The British Society for Rheumatology Psoriatic Arthritis Register (BSR-PsA) is a prospective registry of patients with PsA, recruited from across Great Britain, who are (a) commencing a bDMARD/tsDMARD; or (b) naïve to all bDMARDs/tsDMARDs. Ethical approval was given by the NHS West of Scotland Research Ethics Committee 3 (reference: 18/WS/0126). Clinical data are extracted from participants' medical records, including symptom onset and diagnosis, joint, skin and nail symptoms, dactylitis and enthesitis. Physical measurements (height, weight and 66/68 joint counts) and a detailed drug history are taken. Participants are also asked to complete questionnaires comprising instruments relating to general health and quality of life, axial disease, sleep and fatigue, impact of disease, functional status, mental health, other symptoms, and occupational status. The study duration is 5 years in the first instance, and all participants are followed up annually until the end of the study. Participants commencing a bDMARD/tsDMARD are also followed up three and six months after the start of therapy. Disease activity, including C-reactive protein, is assessed at each visit; and participants from some centres are invited to donate blood and urine samples for the creation of a biobank. DISCUSSION: Complementing data from randomised trials, results from this study will contribute to the evidence base underpinning the clinical management of psoriatic arthritis. Various analyses will determine the effectiveness and safety of bDMARDs/tsDMARDs in the real-world, will examine the clinical and biological predictors of treatment response, and will provide real-world data on the cost-effectiveness of these therapies, as well as providing informative data important to patients such as quality of life and occupational outcomes. TRIAL REGISTRATION: The full study protocol is registered on the Open Science Framework ( https://osf.io/jzs8n ).

Identifying rheumatic disease patients at high risk and requiring shielding during the COVID-19 pandemic.

Rheumatology teams care for patients with diverse, systemic autoimmune diseases who are often immunosuppressed and at high risk of infections. The current COVID-19 pandemic has presented particular challenges in caring for and managing this patient group. The office of the chief medical officer (CMO) for England contacted the rheumatology community to provide expert advice on the identification of extremely vulnerable patients at very high risk during the COVID-19 pandemic who should be 'shielded'. This involves the patients being asked to strictly self-isolate for at least 12 weeks with additional funded support provided for them to remain at home. A group of rheumatologists (the authors) have devised a pragmatic guide to identifying the very highest risk group using a rapidly developed scoring system which went live simultaneous with the Government announcement on shielding and was cascaded to all rheumatologists working in England.

Methotrexate, rheumatoid arthritis and infection risk: what is the evidence?

Low-dose MTX administered weekly remains a mainstay in the therapy of RA. There is a belief amongst rheumatologists that RA patients taking MTX have both an increased risk and severity of infection. Here we review the published data on the risks of infection associated with the use of MTX in patients with RA and make some recommendations for managing MTX in patients with infection.

Assessing the need for arthritis training among paid carers in UK residential care homes: A focus group and interview study.

OBJECTIVE: The aim of the study was to perform an educational and training needs assessment for arthritis care in residential homes. METHODS: Qualitative data were collected from three purposively selected residential homes: one independent, one in a regional chain and one in a national chain. Three researcher-led focus groups were conducted with paid carers (N = 22) using vignette exercises; interviews were undertaken with 12 residents with joint pain (N = 12), five managerial staff and two general practitioners (GPs). Data were compared and analysed thematically around care practices, communication and training. RESULTS: There is a lack of arthritis awareness among paid carers, although they regularly identify and manage arthritic symptoms. Residents rely on paid carers to recognize when pain and mobility problems are treatable. Senior staff and GPs rely on carers to identify arthritic problems. However, paid carers themselves undervalued the health significance of their activities and lacked the confidence to communicate important information to healthcare professionals. Few of the paid carers had received training in arthritis and many expressed a strong desire to learn about it, to improve their ability to provide better care. CONCLUSIONS: Education for paid carers regarding arthritis is lacking and lags behind education about conditions such as dementia and diabetes. To meet the expectations of their care roles fully, paid carers require an awareness of what arthritis is and how to recognize symptoms. We suggest that training should be aimed at improving confidence in communicating with colleagues, residents and health professionals, with senior care staff receiving more in-depth training.