Pain Clinics in England and Wales experience from a nationwide study Running Title PROMs implementation in specialist pain clinics
Introduction Evaluating outcomes in routine clinical practice is a significant challenge for specialist pain clinics due to the complexity of interventions provided and the subjective nature of pain. This study reports findings from implementation of Patient Reported Outcomes (PROMs) in pain clinics in England and Wales between 2011 2013. Methods A paper based questionnaire was administered at a first appointment in participating centres. This assessed quality of life, experience of health care and health care usage with postal follow up at 6 and 12 months by the research team. Feasibility was assessed in terms of response rates, completion rates and outcomes. Results: Ninety one (56% clinics participated, entering 9588 patients (19% of those eligible) For responders there was a 92% item completion rate. The drop out rate was high, 46% and 19% returned questions at 6 and 12 months respectively. Quality of life at baseline was low, with a mean EQ5D 3L Time Trade Off (TTO) value of 0.32. Amongst responders at 12 months, 92% continued to experience significant pain. For those with planned discharges 30% achieved the Minimal Important Change (MIC) for quality of life. Nonetheless, 70% reported positive experiences of care. A cc ep te d A rt ic le This article is protected by copyright. All rights reserved. Conclusions: Patients attending UK pain clinics report an extraordinarily poor quality of life and difficulty with understanding their condition. Problems with PROMs implementation included initial recruitment, follow up response rates, classification systems and benchmarking. Successful implementation should include use of electronic data capture, feedback and focus on gradual improvement. To achieve this would require extended periods of funding. Introduction Specialist multi disciplinary pain services were developed to meet the needs of patients who cannot be managed by a generalist practitioner. Services are expected to assess and treat complex pain disorders by adopting a biopsychosocial approach through various interdisciplinary, multimodal interventions.(Gallagher 2005, Turk 2002) Governmentsponsored reviews of specialist pain services have highlighted the lack of information on the patient population, treatment offered, and their outcomes.(Department of Health England 2008, Quality Improvement Scotland 2007) The work of IMMPACT has helped the research community with data collection (Dworkin, Turk et al 2005) There is also consensus on which Patient Reported Outcome Measures (PROMs) should be collected in clinical practice (Devlin and Appleby 2010, Clarke et al 2003, Ashburn 2012, Tauben 2012, Kaiser et al 2017) with broad support from the clinical community (Holmes et al 2017) Currently, however, there is only limited information on the practical implementation of patient reported outcome measures (PROMs) in pain services. The benefits of PROMS in improving clinical and cost effectiveness have been shown in diverse areas such as cancer care, joint replacement surgery, wound healing and diabetes (Hoque 2015) In the UK, a clinical registry to collect patient outcomes PACS (Pain Audit Collection System) was established in 2003 and worked well for a small number of services. However, large scale implementation was hampered by incompatibility of software systems, the lack of funding for data analysis and poor quality data from many centres (Griffths, Campbell et al 2003, Hall, Merrett et al 2008) It ceased operation in 2008. Outside the UK other clinical registries have been attempted to a limited extent. In Quebec, Choinere described formation of a patient registry with follow up at six months using PROMs, but only in 5 tertiary centres (Choinere et al 2017) Tardif described a similar process to PACS in Australia to establish the electronic Persistent Pain Outcomes Collaboration (ePOCC: Blanchard et al 2017) and this continues to grow. In the USA, the development of the PROMIS database for capturing patient outcomes (Cella, Yount et al 2010) was then taken up by The Pain Assessment Screening Tool and Outcomes Registry (PASTOR: Cook, Buckenmaier et al 2014) However, no comparison of US centres has been published. Garcia reported successful implementation of PROMs in 316 Spanish pain services, but the use of researchers to recruit and short follow up times limit its generalisability (Garcia et al 2016) A cc ep te d A rt ic le This article is protected by copyright. All rights reserved. The UK government funded a National Pain Audit over a four year cycle from 2010 to 2014 in England and Wales (Price et al 2012) to improve specialist pain care Details of clinics and case mix are described previously (Price 2018) The brief was to develop a robust database that all specialist pain services could submit to (Department of Health 2008) This paper aims to evaluate the feasibility of PROMS collection through formation of a patient registry to over a one year journey, (from 2011 13) in order to inform future data collection across the spectrum of pain clinics in England and Wales, using clinic based recruitment with postal follow up by researchers. Methods Study Design and setting This was a cohort study nested within a National Pain Audit (Price et al 2012) with a focus on assessing the feasibility of data completion and response rates to a PROMS questionnaire. One hundred and sixty one pain clinics in England or Wales, identified in the National Pain Audit as specialist pain services (International Association for the Study of Pain 2009) were invited to recruit patients to this PROMs study. Participation in National Audits is expected for National Health Service (NHS) organisations although there are no penalties for non participation. Subjects All children over 12 years old and adult patients in England or Wales attending for the first time during a three month period between 2011 and 2012 were eligible for inclusion. Patients with cognitive or language difficulties were included if they were able to successfully complete a questionnaire with an interpreter or with help as judged appropriate by the clinic. Patients who declined to complete the questionnaire, or for whom the clinician failed to enter sufficient details on the case mix tool (see below) were excluded. Support with data collection was provided for the clinics through a series of Frequently Answered Questions on the National Pain Audit webpages and a helpline. Data Collection Period The patient reported outcomes element consisted of three phases. In year 1, while services were being identified and enrolled, the questionnaire and a web tool for clinicians to enter clinical details were assembled and piloted in 12 centres. In year 2 of the audit, each participating clinic was asked to enrol patients over three months of continuous data collection throughout the period of one year at a point when a provider felt most ready to start collection. It was felt that the focused period would maximise the likelihood of collection. Clinical details were entered into a web tool by the clinician seeing the patient. This was developed by Dr Foster Research UK, the main contractor for the Audit. Each patient completed a paper set of questions that was retained by the clinic and returned to the study team. This cohort was then followed up after 6 and 12 months from entry by direct mailing by post of follow up questions by Dr Foster Research UK, with patients invited to telephone if they had difficulty. Further reminders to complete the questions were not issued. A cc ep te d A rt ic le This article is protected by copyright. All rights reserved. Web tool development An earlier entry of patient data into a Pain Collection System that was Microsoft Accessbased (Griffiths 2003) produced problems at interfaces with hospital IT systems, especially when Access was upgraded. A web based system was therefore developed by the main contractor to enter patient details and case mix (supplemental data) A pilot of this over a six month period with 12 clinicians across England demonstrated that clinicians struggled to enter ICD 10 codes, with many refusing to enter data. For this reason, and to ensure maximal uptake of the audit, free text diagnoses were permitted. Questionnaire Development The selection of PROMS was guided by the Department of health guidance on PROMS which recommends a generic measure and a disease specific measure. We had previously used the Brief Pain Inventory in the PACS database (Griffiths 2003) after substantial testing of alternatives. The generic quality of life measure EQ5D was selected as it is used by the national PROMS audit (Department of Health 2012).Treatments were grouped based on a previous database PACS (Griffiths 2003) As in the well established PROMS Hip and Knee Audits (NHS Digital 2014) a disease specific scale (the Brief Pain Inventory) and a global scale of health (Euroqol 5D 3L) were chosen. The Brief Pain Inventory (Keller et al 2004, Tan et al 2004) has demonstrated utility in terms of data entry and analysis in UK pain clinics (Hall et al 2008) The Euroqol 5D 3L (EQ5D 3L) has been shown to be relatively responsive in the chronic pain population (Obradovic 2013) and its use enables quality of life comparisons with people with other long term disabling conditions. Work and healthcare resource questions that elicited data on unemployment, presenteeism and absenteeism were chosen on advice of experts. Ratings of the usefulness of the service and patient satisfaction were developed with patient groups. Personal data collected were age and sex; ethnicity (Office for National Statistics 2011) was collected only for the final follow up. Patients were also asked what treatment they had received using a classification that had earlier been developed with the Department of Health in relation to waiting times for care pathways (Department of Health 2010) The patient groups and clinicians reviewed and approved the PROMs and a pilo