ABSTRACT Introduction The Consortium to Research Individual, Interpersonal and Social Influences in Pain (CRIISP) is a 4‐year UK university collaboration investigating how thoughts and feelings, personal relationships and lifestyle can affect chronic pain. Patient and public involvement in research recognises that researchers' conceptions of health and illness can be enriched and sense‐checked by those of people experiencing a health condition. Published literature reports a gap in meaningful patient and public involvement in research into chronic pain, for example, during early study design. Input in this formative stage aimed to ensure the research proposed had a patient‐centred focus which may benefit study implementation. We describe how the authors sought to address this gap and established a diverse public involvement (PI) network to support the CRIISP research. Methods Thirty‐six adult public contributors were appointed to work alongside the research teams. Lessons learned are presented under the themes: optimising collaborative working, recruitment of public contributors, supporting public involvement throughout CRIISP and the retention of public contributors. Throughout this paper, we refer to the term ‘public involvement’ rather than ‘patient and public involvement’ in accordance with the NIHR definition which incorporates people with a range of experiences. Results Working in partnership with our public contributors, we have embedded PI throughout a chronic pain research programme using an innovative and collaborative process. Conclusion This model may inform others to maximise the potential of PI within their research. Patient or Public Contribution The paper reports the collaboration between public contributors with a lived experience of chronic pain and the Consortium to Research Individual, Interpersonal and Social influences in Pain (CRIISP) researchers, by means of a large public involvement network.

Introduction:Sensory discrimination training has demonstrated improvements in two-point discrimination and pain reduction in people with chronic pain. We tested the feasibility and acceptability of a novel Sensory Training System (STS) device in the homes of people with Type 1 Complex Regional Pain Syndrome (CRPS). Methods:Participants meeting CRPS diagnostic criteria were invited to use the STS for a minimum of 30 minutes per day for 30 days. Device usage data were captured by the STS. Assessments at baseline and after 30 days were: two-point discrimination ability, pain intensity and interference, sensitivity and emotions towards CRPS limb. Qualitative interviews were conducted at the end of the study to capture participants' feedback on the device. Results:A total of 10 participants (female n = 7) completed the study. Participants' mean age was 56.4 years (range: 24-78 years), and mean disease duration was 9.37 years (range: 4.25-26.5). Eight had lower limb CRPS. The mean STS device use was 27.3 ± 3.4 days and mean daily usage of training games was 00:27:11 ± 00:07:52 (hh:mm:ss). No patterns or trends were evident between device usage and outcome data. Conclusion:This feasibility study of a home-based STS for people with CRPS revealed key areas for improvement in the device's hardware and software and outlined the challenges of development and testing during the COVID-19 pandemic, while also capturing valuable usability insights from participant feedback. Key recommendations include early and ongoing collaboration with users, securing sufficient funding, ensuring correct device setup by participants, conducting interim analysis, and using online tools to enhance participant experience and data collection. Study registration:The study was registered with ISRCTN registry on 28th May 2021 (https://doi.org/10.1186/ISRCTN89099843).

Complex regional pain syndrome (CRPS) is a rare and disabling pain disorder. Systematic reviews have identified a critical lack of adequately powered, high quality clinical trial evidence to inform the management of CRPS. There is an urgent need to find solutions to the methodological challenges of undertaking clinical trials in CRPS. The aim of the ‘Optimising clinical trial methods for complex regional pain syndrome’ (OptiMeth-CRPS) network project was to develop a methodological framework for optimising the planning, design, conduct and reporting of future clinical trials in CRPS (OptiMeth-CRPS). We employed an ‘Experience and expertise’ approach to develop a methodological framework. The framework was developed by an international group with expertise in the lived experience of CRPS, CRPS research, clinical trials, CRPS evidence synthesis and rare disease research methods. We used an iterative process of i) online and face-to-face meetings, ii) reviewing and approving meeting notes detailing the group’s discussions and iii) revising draft manuscripts to develop the framework. This white paper presents the discussions and recommendations of the OptiMeth-CRPS network project. The OptiMeth-CRPS methodological framework presents nine key optimisation strategies for improving the planning, design, conduct and reporting of CRPS trials. These include strategies for optimising i) the trial team, ii) research questions, iii) trial governance and management, iv) trial design, v) the trial population, vi) intervention and comparator groups, vii) trial outcomes, viii) data analysis, and xi) openness, transparency and reporting. The OptiMeth-CRPS methodological framework is offered as a tool to support the CRPS research community to undertake high quality clinical trial research and improve the quality of the evidence upon which clinical decisions and guidelines for the management of CRPS are based.

#400WORDS: DELIVERING A RESEARCH SKILLED WORKFORCE SPECIAL EDITION

AimTo explore and summarise published literature with regards to secondments to clinical research and to identify the gaps in research to inform further work.DesignSystematic scoping review.MethodA scoping review was undertaken in accordance with the Patterns, Advances, Gaps, Evidence and Research framework. Databases searched included CINAHL, PubMed, Medline and Embase. Inclusion/exclusion criteria were applied by two independent reviewers. Two reviewers independently retrieved full-text studies for inclusion and applied the framework as a tool for synthesising Patterns, Advances, Gaps, Evidence and Research recommendations.ResultsSix papers and one abstract published between 2003 and 2018 were included. All secondees (n = 34) were released from NHS posts, with secondments (where specified) ranging in duration from 0.25 to 2 years and for 40%-100% of their working hours. All seven papers reported benefits for personal and professional development, predominantly in the form of personal reflections. Few described involvement with research delivery teams.ConclusionPublished initiatives vary in nature and lack standardised reporting and measurement of impact. Further research is required to identify benefits at a departmental or organisational level, the facilitators for setting up secondments and the application of knowledge gained from secondment opportunities.Implications for the ProfessionUndertaking a research secondment is reported to offer professional and personal benefit for clinical staff. Research secondments are one way in which a research culture can practically be embedded within clinical settings.ImpactThis scoping review identified a lack of published empirical research seeking to understand research secondments as a tool to enhance research and evidence engagement. Although there is a suggestion that secondments could positively impact staff retention, there is limited evidence about the benefit for the organisation or for patient care. These findings have implications for staff, managers and their organisations.Reporting MethodThe PRISMA-ScR guidelines were used to guide reporting.No Patient or Public ContributionThis was not relevant to the research design.

INTRODUCTION:Complex regional pain syndrome (CRPS) is a disabling and distressing chronic pain condition characterised by a range of sensory, motor, autonomic and trophic symptoms. UK guidelines recommend therapy interventions to help normalise touch perception through self-administered tactile and thermal desensitisation activities. Interventions have been developed, aiming to help individuals broaden their sensory experience, thereby relieving chronic pain. However, therapy-led interventions often experience practical constraints and poor adherence. In response, a sensory training system (STS) device has been designed for unsupervised independent home-use.METHODS:This proof-of-concept study aims to explore whether people with CRPS use the device at home for 30 minutes a day for 30 days. Secondary aims are to determine whether the STS device will change tactile acuity and perceived levels of pain intensity, pain interference, sensitivity or feelings towards the affected limb. We will seek to recruit 20 eligible participants. Participants will be asked to measure tactile acuity using a two-point discrimination assessment, complete an online questionnaire before and after use of the device and complete a daily diary. On completion of the 30-day use, participants will be invited to take part in a semi-structured interview to explore their experiences of using the device.ANALYSIS:Pain intensity and pain interference will be scored using the online Assessment Center Scoring Service or using the look-up table in the PROMIS scoring manual. The remaining questionnaire data, including tactile acuity results, and device-use data, including frequency and duration of use, will be analysed using descriptive statistics. Qualitative data will be thematically analysed.ETHICS AND DISSEMINATION:London-Stanmore Research Ethics Committee provided a favourable opinion on 19 April 2021 (ref 21/LO/0200). The NHS Health Research Authority, UK, approved this study on 7 June 2021. Dissemination will include peer-reviewed publications, presentations at conferences, social media and reports to the funder and patient charities.TRIAL REGISTRATION NUMBER:ISRCTN89099843.

Background Complex regional pain syndrome (CRPS) can be a debilitating pain condition with enduring physical, psychological and social impacts. CRPS is often poorly understood by healthcare professionals and management needs to be tailored to each individual's presentation. People with lived experience express difficulty in accessing reliable and meaningful information about the condition. This study aimed to co-create a trustworthy infographic to share information about the lived experience of CRPS. Methods We adopted a seven-phase, iterative, participatory methodology to co-create the infographic. Potential infographic content was obtained from qualitative work investigating the lived experience of CRPS. Online consumer engagement (people with doctor diagnosed CRPS/their family, n=20) was used to prioritise content to be included in the infographic and then potential designs were sourced. The research team narrowed the selections down to two designs which were presented to consumers online for final selection (n=25) and refinement (n=34). Results An infographic for understanding the lived experience of CRPS was completed using participatory design, providing a resource aligned to the needs of people with this condition. Using the Patient Education Materials Assessment Tool, the final infographic rated highly for understandability (92%) and participants indicated significant willingness to share this infographic with others (93%). Conclusion A process of participatory design was an effective and efficient process for translation of evidence gathered from qualitative research into a trustworthy resource for people with CRPS and their support people.

Introduction Complex Regional Pain Syndrome (CRPS) is a persistent pain condition with low prevalence. Multi-centre collaborative research is needed to attain sufficient sample sizes for meaningful studies. This international observational study: (1) tested the feasibility and acceptability of collecting outcome data using an agreed core measurement set (2) tested and refined an electronic data management system to collect and manage the data. Methods Adults with CRPS, meeting the Budapest diagnostic clinical criteria, were recruited to the study from 7 international research centres. After informed consent, a questionnaire comprising the core set outcome measures was completed: on paper at baseline (T1), and at 3 or 6 months (T2) using a paper or e-version. Participants and clinicians provided feedback on the data collection process. Clinicians completed the CRPS severity score at T1 and optionally, at T2. Ethical approval was obtained at each international centre. Results Ninety-eight adults were recruited (female n=66; mean age 46.6 years, range 19-89), of whom 32% chose to receive the T2 questionnaire in an electronic format. Fifty-five participants completed both T1 and T2. Eighteen participants and nine clinicians provided feedback on their data collection experience. Conclusion This study confirmed the questionnaire core outcome data are feasible and practicable to collect in clinical practice. The electronic data management system provided a robust means of collecting and managing the data across an international population. The findings have informed the final data collection tools and processes which will comprise the first international, clinical research registry and data bank for CRPS.

Objective To assess the degree of resilience in patients with complex regional pain syndrome (CRPS) 1, to explore the relationship between resilience and patient-related outcome measurements and to describe a pattern of clinical manifestations associated with low resilience. Methods This study presents a cross-sectional analysis of baseline information collected from patients enrolled in a single center study between February 2019 and June 2021. Participants were recruited from the outpatient clinic of the Department of Physical Medicine & Rheumatology of the Balgrist University Hospital, Zurich, Switzerland. We used linear regression analysis to explore association of resilience with patient reported outcomes at baseline. Furthermore, we explored the impact of significant variables on the low degree resilience using logistic regression analysis. Results Seventy-one patients (females 90.1%, mean age 51.2 +/- 12.9 years) were enrolled. There was no association between CRPS severity and the level of resilience. Quality of Life was positively correlated with resilience, as was pain self-efficacy. Pain catastrophizing was inversely correlated with the level of resilience. We observed a significant inverse association between anxiety, depression and fatigue and the level of resilience. The proportion of patients with a low resilience increased with higher level of anxiety, depression and fatigue on the PROMIS-29, without reaching statistical significance. Conclusion Resilience seems to be an independent factor in CRPS 1 and is associated with relevant parameters of the condition. Therefore, caretakers may screen the current resilience status of CRPS 1 patients to offer a supplementary treatment approach. Whether specific resilience training modifies CRPS 1 course, requires further investigations.

Background: Mandatory NHS Trust induction programmes are an integral part of staff orientation processes. Although research is recognised as fundamental to high-quality care, little data exist regarding whether research information is included within hospital induction. Methods: Two online national surveys were developed, with the aim of identifying Trusts which included research within their mandatory induction programme. Survey 1 was distributed to Research and Development managers across England (n = 201). Survey 2 collated information on the research content and delivery methods of induction material. The work was classified as a service evaluation and reported in accordance with CHERRIES reporting standards. Results: Survey 1 generated 124 unique responses (61% response rate). Thirty-nine percent of Trusts (n = 48) featured information about research delivery and 24% (n = 30) about training or support to develop clinical academic careers. There was wide variation in how materials were delivered, by whom and for how long. Conclusions: Currently research has a limited profile within English NHS Trust mandatory induction programmes. This needs to be addressed if research is truly to be considered part of the core National Health Service business. Guidance or a modifiable template could help Trusts communicate about research delivery and clinical academic development and training to all new employees.

1. Introduction We present a framework for the study of states of chronic pain and transitions between those states. We capture in the framework the dynamic nature of pain: people live with pain that changes over time. First, we offer definitions of both acute and chronic pain and explore the contextual considerations related to the common use of this temporal dichotomy. Second, we promote the importance of incorporating the impact pain has on a person's life. Finally, we discuss the challenges and opportunities inherent in implementing this common approach. Our goal is to produce a framework for the study of the development, maintenance, and resolution of chronic pain. Whether a single brief event or a constant feature of life, pain interrupts to prioritise protection, interferes with activity, reduces quality of life, and can alter identity.44 Protection is achieved by escape from harm, avoidance of perceived danger, withdrawal for respite and repair, and communication of incapacity and environmental risk; longer-term protection is achieved by learning the cues for pain and injury.53 From this perspective, pain is most usefully considered a need state, fundamentally a motivational drive to protect.49 This approach centres our attention on the consequences of pain for the person in their context, on its duration and its impact. 2. A person's pain status Pain is defined as “an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage.”34 There is a logical case of a state of “no pain,” but to have no pain is a rare occurrence, only recently made possible by the advent of anaesthesia/analgesia. A state of the continuous absence of any pain at all is profoundly abnormal, appearing only as congenital nociceptor deficiency or dysfunction. It is far from adaptive, notably leading to major clinical problems associated with the absence of defensive responding and learning with a consequent severe shortening of life expectancy.9,50,51 2.1. Acute and chronic The terms “acute” and “chronic” represent a temporal dichotomy, with “acute” meaning short lived or immediate, and chronic meaning long term. Colloquially, however, both can be used interchangeably to mean “bad,” causing confusion in clinical encounters when patients use these as terms for severity or impact and clinicians use them for temporality.5 In this article, we use “acute pain” to mean pain of short duration, without any implication of severity or urgency. The pragmatic challenge in its use is the length of this short duration. Acute pain is typically defined as lasting from onset to 3 months in duration and so encompasses everything from a momentary muscular “cramp” to postoperative pain.27,52 Therefore, acute pain is both common and a normal part of everyday life. The few studies that establish the base rate of everyday pain generally report high incidence. For example, in 1 observational study of everyday pain in 3- to 7-year-olds, the event rate was 0.33 incidents per hour per child.31 Painful bumps and scrapes in the playground are normal. For adults, episodes of naturally occurring acute pain are also common. In a Europeanwide study of 8506 patients, 70% of adults reported at least 1 pain event a month (such as headache, menstrual pain, and muscle pain).48 Acute pain can also occur deliberately as part of a social process (eg, body adornment, contact sport, or ritual). However, most everyday acute pain does not require clinical intervention; it is self-limiting. Clinical studies often focus on pain related to medical procedures or that occurs as the result of illness, disease, or injury (accidental, self-induced, or medically induced), and although acute pain can be relatively straightforward to manage, in particular when the timing and extent of trauma are controlled, it is not always so simple. Acute pain can be complicated for healthcare professionals to assess and manage when there are concurrent symptoms or conditions, it occurs in the presence of chronic pain, or when communication about pain is difficult, for instance in an emergency.23 Furthermore, we recognise that the 3-month limit is an arbitrary distinction that can lead to problems. For example, it does not account for life stage. Consider the case of new-born babies who receive repeated needle sticks for diagnostic tests: Each pain may be acute, but the pain has been present for most of the child's life. For a baby, less than 3 months is not a “short” duration. These and other concerns have led some to question the focus on duration in definitions, suggesting instead a focus on presumed mechanism.8 Pain of longer duration is known as “chronic pain.” Typically, chronic means having lasted for 3 months or more, as captured in the IASP definition and more recently included in ICD-11.38 Historically, chronic pain was considered to start at 6 months for adults and 3 months for children. The problem of definitions that privilege duration has been discussed,46 and 3 months for adult and child is now thought more clinically relevant. Given the consensus on the use of a 3-month definition, this serves as the dividing boundary that differentiates chronic from acute pain. This definition has some difficulties. As with acute pain, 3 months is an absolute cutoff: 3 months for a 6-month-old is 50% of a life, whereas for a 60-year-old, 3 months is 0.4% of a life. If a child of 2 months has lived their life in pain, this definition of chronic would not apply, which in some circumstances would be more clinically meaningful.25 Furthermore, many people report pain that changes in quality or location and which fluctuates and/or is episodic. Consider that the International Headache Society classifies a number of chronic headaches as episodic with different decisions about the number, frequency, and extent of episodes,20 as do the Rome IV Diagnostic Criteria for Functional Gastrointestinal Disorders, which are less exact and use phrases such as “continuous,” “nearly continuous,” and “intermittent.”37 Including frequency in the definition of chronic low back pain may be useful and lead to a more accurate identification of treatment responders.22 In short, a category of chronic pain needs to encompass the experience of people who have intermittent, episodic, or continuous pain, pain of different quality and intensity, and the pain may be a sole primary complaint, secondary to disease and illness, or one of several chronic complaints.29,43 The variability in nosology emerging from different clinical specialities, and considerations of duration in the context of longevity, does not negate the value of a simple duration dichotomy (acute–chronic). We argue for the informed use of context when considering its use, and the need to look beyond simple labels when combining data or insights. It is a useful starting point to explore the specific features of that temporal definition in context. 2.2. High- and low-impact acute and chronic pain Pain can impact multiple aspects of a person's life. We prefer “impact” over other common terms, such as disability, suffering, or distress, because it draws attention to the diverse effects of pain on the person. It is generally used conditionally to refer to the consequences of pain on a particular outcome.13,39,42 Duration is not a good predictor of impact. A momentary pain of an accident, incident, or procedure can have drastic effects on a person. One example is the cumulative effects of repeated exposure to acute pain in new-born babies on brain development.2 Another is the potential role of discrete painful events as psychologically traumatic, leading to major impact.35 And, a third is of uncontrolled pain near end of life, which may last less than 3 months but which can be devastating for a person and significant others.28 Discriminating by impact is more common in considerations of chronic pain. In particular, “high-impact chronic pain”has been defined in the United States as activity limitation47 and later as activity and participation limitation,33,39 contrasted with a category of chronic pain without limitations. This thinking was more recently captured in the Graded Chronic Pain Scale Revised as high impact compared with mild or bothersome pain.45 These categories allow for greater discrimination when trying to bridge between population-based studies of prevalence of chronic pain and clinical studies with adults expressing healthcare needs. The prevalence of adults with high-impact chronic pain is more typically estimated conservatively as at least 5%, in contrast to the headline population figures for all chronic pain, conservatively estimated at 20%.33,55 The idea that chronic pain can have low or no impact is an interesting one. Indeed, the potential for the existence of pain without impact is at the heart of the biopsychosocial model6,16,17 and a treatment goal in psychological rehabilitation.54 Although the complete resolution of chronic pain is desirable as a treatment objective, the transition to a state of low(er) impact chronic pain is often more realistic and still an important objective for individuals, healthcare providers, and society. An example is in the context of normal ageing with accommodation to life with increasingly unreachable goals achieved by altering those goals.12 For our purposes, high impact is defined by the extent of difficulties in function and disability (self-care, occupational engagement, and social activities)26 in line with the WHO. Again, we propose an informed and context-dependent use, with the need to look beyond simple labels when combining data or insights. It is a useful starting point to explore the specific features of how high impact can be determined from the available measurement. 3. States and transition Taking duration and impact together, we propose a transitional framework for the study of 5 categorical “states” (Table 1 and Fig. 1), which include acute low-impact pain, acute high-impact pain, chronic low-impact pain, chronic high-impact pain, and a “resolved” no chronic pain state. Table 1 - States of pain. Duration Impact Features Acute pain Low impact Pain of less than 3-mo duration that is not associated with major self-care, occupational, and social activity restrictions Pain of less than 3-mo duration can occur in a normal everyday context. Examples are inoculation, minor injury, or pain incidental to aesthetics or recreation Acute pain High impact Pain of less than 3-mo duration that is associated with major social, personal, or role restrictions Pain of less than 3-mo duration can have a major impact. Examples are major trauma, headache, end of life pain Chronic pain Low impact Pain of 3 mo or more duration that is not associated with major social, personal or role restrictions Pain of 3 mo or longer can be related to a disease or be a primary disorder of the nervous system but can have minor impact Chronic pain High impact Pain of 3 mo or more duration that is associated with major social, personal, or role restrictions Pain of 3 mo or longer can be related to a disease or be a primary disorder of the nervous system but can have major impact Chronic pain (resolution) No impact The chronic pain of interest can progress to a new state of resolved chronic pain This new state is similar to acute pain of low impact in which everyday pain may occur but is always in the context of having had chronic pain Figure 1.: A framework for the establishment, maintenance, and adaptation of high- and low-impact chronic pain: Pain is described with 2 dominant dimensions: duration and impact. Both are dichotomised to establish specific states. Duration is split into acute pain defined as pain lasting less than 3 months and chronic as pain of 3-month duration or longer. Impact is split into low and high impact defined as a minor or major impact on self-care, occupational, and social activities. No specific measurement technology or method for determining the cutoffs is prescribed because this is a frame to capture multiple contexts of study. These 2 dimensions allow for 5 possible states represented in the oval shapes, including: acute low-impact pain and acute high-impact pain, chronic low-impact pain and chronic high-impact pain, and finally a special case of resolution of chronic pain. These 5 states allow for 10 possible transitions over time, which are given in Table 2. One cannot change from chronic to acute pain. This is a static representation of a set of dynamic processes, and we recognise that one can move between states over time, especially between chronic low impact and chronic high impact. We recognise also that chronic pain, once resolved, can relapse.Although we refer here to pain duration (acute, chronic) and impact (high, low) as dichotomies, we recognise the continuous, overlapping and dynamic aspect of the pain experience. For many people, pain is an additional burden to other diseases. Our choices here are illustrative not ontological providing a framework for investigation—placing an emphasis on measurement and its use within individual investigations. In line with the US pain strategy,26 we recognise that introducing categories creates opportunities for research, in particular population-based research, but can under some circumstances lead to a statistical loss of information. Table 2 outlines 10 possible trajectories of change in states, representing transitions (or absence of transition) in a person's pain state. We are interested in the onset of chronic pain, whether it is low or high impact, and its starting point of low- or high-impact acute pain. We are also interested in no change, or the maintenance of chronic pain, whether low or high impact, and the factors that lead to people becoming “stuck” in their pain state.3 And finally, we are interested in change in state, worsening from low impact to high impact, or improving from high impact to low impact, or a resolution from chronic low- or high-impact pain back: transition to a new normal state in which the specific pain(s) meeting the criteria for chronicity has/have resolved, but the natural rate of everyday pain resumes. These states and transitions are outlined in Figure 1. Table 2 - Possible transitions between chronic pain states. Chronic pain status 1st observation 2nd observation Onset Acute low impact Chronic low impact Onset Acute low impact Chronic high impact Onset Acute high impact Chronic low impact Onset Acute high impact Chronic high impact Change (worsening) Chronic low impact Chronic high impact Change (improving) Chronic high impact Chronic low impact Change (resolution) Chronic low impact Chronic pain resolution Change (resolution) Chronic high impact Chronic pain resolution Maintenance Chronic low impact Chronic low impact Maintenance Chronic high impact Chronic high impact 4. Further considerations Our focus on duration and impact raises several issues for consideration: (1) Pain can be described by its pathological cause, mechanism, intensity, location, frequency, diurnality, or as a collection of features in a measure of severity. Such features are important, but, in this framework, they would be held in analyses as potential predictors, correlates, or process variables in an examination of impact and duration rather than part of their definition. (2) The premise that a person can have chronic pain with low impact clashes with the ICD-11 definition of primary chronic pain, a clinical diagnostic scheme that assumes high impact as a core part of the definition.30 (3) The concept of transition has been questioned because of an often tacit acceptance of a change in mechanism from acute to chronic pain. We make no reference to specific mechanisms but agree with the recommendation, where possible, “…to track individual pain types over time because they are likely to have different pain progression and resolution mechanisms and require different interventions.”15 (4) We also acknowledge that at any time point, acute and chronic pain can co-occur, but in this framework are focusing on the transition to/from chronic pain. (5) Related is the assumption that chronic pain is pain that is refractory to treatment. There is a need to establish evidence for refractory chronic pain monitoring treatment(s) and their unsuccessful outcomes. To date, there is no broadly accepted and generalisable definition of treatment-resistant chronic pain. (6) Similarly, Figure 1 is a static representation of changes in pain state. We recognise that one can move between high- and low-impact pain, and that pain can resolve and then relapse.40 (7) Living with longstanding pain can have a broad lasting impact on life that might endure past pain resolution. (8) A focus on duration and impact privileges the individual. Chronic pain has an impact beyond the individual to other individuals, to society and to the economy. This duration-impact framework has been developed in the context of a major UK research programme investigating the psychosocial determinants of high-impact chronic pain7 funded by the Advanced Pain Discovery Platform.1 The APDP has a focus on determining the causal influences on the onset and maintenance of high- and low-impact chronic pain. The consortium7 is exploring determinants of pain-state transitions using existing databases such as ALSPAC,4,18,32 ELSA,14 UK BIOBANK,41 HWW,24 and HEAF21 the synthesis of findings across published studies,19 and through new investigations. This framework is the first step in helping to clarify clinical and research questions. First, we need to understand how to manage the uncertainty inherent in the use of measurement technology designed to capture impact and establish how far what has already been measured corresponds with, or diverts from, this framework. Second, as we are interested in factors that are causally relevant to the onset, maintenance, and change in states over time, testing causal models needs to be carefully formulated. And third, this framework can direct the selection of appropriate endpoints for intervention in attempting to alter unwanted pain states. As important as pain offset (resolution) is the improvement in impact status, from high to low. A reasonable treatment outcome for many, and therefore a clinical endpoint, is to move from high-impact to low-impact chronic pain.10,11,36 5. Conclusion We propose a framework for studying the biopsychosocial influences on the onset, maintenance, and change in of chronic pain state. In accepting and interrogating the common dichotomies of duration (acute, chronic) and impact (high, low), we recognise the challenges inherent in dichotomizing continuous and dynamic experience. Pragmatically, however, this allows us to propose 5 unique states of pain and 10 transitions. This framework promotes a consideration of impact over time on the person with pain and will enable investigation of the causal determinants of states and changes in state. Conflict of interest statement The authors have no conflict of interest to declare.

ABSTRACT Complex regional pain syndrome (CRPS) clinical trials have historically captured a diverse range of outcomes. A minimum set of CRPS patient-reported outcomes has been agreed for inclusion in a future CRPS international clinical research registry and data bank. This study aimed to identify a complementary set of core clinical outcomes. Clinicians and researchers from the international CRPS community informed the content of a 2-round electronic Delphi study. Participation was invited from members of the International Association for the Study of Pain CRPS Special Interest Group and the International Research Consortium for CRPS. In round 1, participants rated the relevance of 59 clinical outcomes in relation to the question "What is the clinical presentation and course of CRPS, and what factors influence it?" (1 = not relevant and 9 = highly relevant). In round 2, participants rerated each outcome in the light of the round 1 median scores. The criterion for consensus was median score ≥7, agreed by 75% of respondents. The core study team considered the feasibility of data collection of each identified outcome in agreeing final selections. Sixty respondents completed both survey rounds, with responses broadly consistent across professions. Nine outcomes met the consensus criterion. Final outcomes recommended for inclusion in the core clinical set were record of medications, presence of posttraumatic stress disorder, extent of allodynia, and skin temperature difference between limbs. Study findings provide robust recommendations for core clinical outcome data fields in the future CPRS international clinical research registry. Alongside patient-reported outcomes, these data will enable a better understanding of CRPS.

There have been some modest recent advancements in the research of Complex Regional Pain Syndrome, yet the amount and quality of the work in this complicated multifactorial disease remains low (with some notable exceptions; e.g., the recent work on the dorsal root ganglion stimulation). The semi-systematic (though in some cases narrative) approach to review is necessary so that we might treat our patients while waiting for “better research.” This semi-systematic review was conducted by experts in the field, (deliberately) some of whom are promising young researchers supplemented by the experience of “elder statesman” researchers, who all mention the system they have used to examine the literature. What we found is generally low- to medium-quality research with small numbers of subjects; however, there are some recent exceptions to this. The primary reason for this paucity of research is the fact that this is a rare disease, and it is very difficult to acquire a sufficient sample size for statistical significance using traditional statistical approaches. Several larger trials have failed, probably due to using the broad general diagnostic criteria (the “Budapest” criteria) in a multifactorial/multi-mechanism disease. Responsive subsets can often be identified in these larger trials, but not sufficient to achieve statistically significant results in the general diagnostic grouping. This being the case the authors have necessarily included data from less compelling protocols, including trials such as case series and even in some instances case reports/empirical information. In the humanitarian spirit of treating our often desperate patients with this rare syndrome, without great evidence, we must take what data we can find (as in this work) and tailor a treatment regime for each patient.

British Journal of NursingVol. 29, No. 4 CommentThe NIHR [email protected] programme: transforming researchEnrique Castro-Sánchez, Carrie-Ann Black, Claire Whitehouse, Naomi Hare, Linda Tinkler, Fiona Maxton, Janine Valentine, Sharon Grieve, on behalf of the 2019−2022 NIHR [email protected] Senior Nurse and Midwife Research LeadersEnrique Castro-Sánchez(E-mail Address: [email protected])Lead Academic Research Nurse, Imperial College London, and Imperial College Healthcare NHS Trust, London, Carrie-Ann BlackCAMHS Research and Quality Improvement Nurse Lead, South London and Maudsley NHS Foundation Trust, London, Claire WhitehouseSenior Nurse, James Paget University Hospitals NHS Foundation Trust, Norwich, Naomi HareResearch Matron, Guy's and St Thomas' NHS Foundation Trust, London, Linda TinklerTrust Lead for NMAHP Research, Education & Practice Development, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, Fiona MaxtonLead Nurse—Research & Development, North West Anglia NHS Foundation Trust, Peterborough, Janine ValentineConsultant Nurse/Research Leader, Yeovil District Hospital NHS Foundation Trust, Yeovil, Sharon GrieveLead Pain Research Nurse, Royal United Hospitals Bath NHS Foundation Trust, Bath, on behalf of the 2019−2022 NIHR [email protected] Senior Nurse and Midwife Research LeadersEnrique Castro-Sánchez; Carrie-Ann Black; Claire Whitehouse; Naomi Hare; Linda Tinkler; Fiona Maxton; Janine Valentine; Sharon Grieve; on behalf of the 2019−2022 NIHR [email protected] Senior Nurse and Midwife Research LeadersPublished Online:27 Feb 2020https://doi.org/10.12968/bjon.2020.29.4.240AboutSectionsView articleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InEmail View article References Bender M, Baker P, Harris JL et al.. Advancing the clinical nurse leader model through academic-practice-policy partnership. Nursing Outlook. 2019;67(4):345-353. https://doi.org/10.1016/j.outlook.2019.02.007 Crossref, Medline, Google ScholarBoaz A, Hanney S, Jones T, Soper B. Does the engagement of clinicians and organisations in research improve healthcare performance: a three-stage review. BMJ Open. 2015;5(12):e009415. https://doi.org/10.1136/bmjopen-2015-009415 Crossref, Medline, Google ScholarCarrick-Sen D, Richardson A, Moore A, Dolan S. Transforming healthcare through clinical academic roles in nursing, midwifery and allied health professions: a practical resource for healthcare provider organisations. London: Association of UK University Hospitals (AUKUH); 2016. https://tinyurl.com/t3q2ejh (accessed 5 February 2020) Google ScholarFinch J for the Working Group on Expanding Access to Published Research Findings. Accessibility, sustainability, excellence: how to expand access to research publications. Executive summary. 2012. https://tinyurl.com/clb2cpr (accessed 31 January 2020) Google ScholarHanney SR, González-Block MA. Organising health research systems as a key to improving health: the World Health Report 2013 and how to make further progress. Health Res Policy Syst. 2013;11:47. https://doi.org/10.1186/1478-4505-11-47 Crossref, Medline, Google ScholarMay R. Celebrating nursing. RCN Bulletin. 30 April 2019. https://tinyurl.com/yx5yeu5m (accessed 31 January 2020) Google ScholarNational Institute for Health Research. [email protected] The NIHR senior nurse and midwife research leader programme. 2018. https://tinyurl.com/y9jqz5aa (accessed 31 January 2020 Google ScholarNHS England, NHS Improvement. Interim NHS people plan. 2019. https://tinyurl.com/y2w9pbm4 (accessed 31 January 2020) Google ScholarOzdemir BA, Karthikesalingam A, Sinha S et al.. Research activity and the association with mortality. PLoS One. 2015;10(2):e0118253. https://doi.org/10.1371/journal.pone.0118253 Crossref, Medline, Google Scholar FiguresReferencesRelatedDetails 27 February 2020Volume 29Issue 4ISSN (print): 0966-0461ISSN (online): 2052-2819 Metrics History Published online 27 February 2020 Published in print 27 February 2020 Information© MA Healthcare LimitedAcknowledgments:Enrique Castro-Sánchez is affiliated with the National Institute for Health Research Health Protection Research Unit (NIHR HPRU) (grant number HPRU-2012-10047) in Healthcare Associated Infections and Antimicrobial Resistance at Imperial College London, in partnership with Public Health England (PHE), and acknowledges the support of the NIHR Biomedical Research Centre. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, the Department of Health or PHE. All authors are NIHR senior nurse and midwife research leaders, and gratefully acknowledge the support provided by the regional NIHR [email protected] Hub leadersPDF download

Objectives This international, multicentre study will inform the final data collection tools and processes which will comprise the first international, clinical research registry for complex regional pain syndrome (CRPS). This study will: (a) test the feasibility and acceptability of collecting outcome measurement data using a patient reported, questionnaire core measurement set (COMPACT [Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies]); and (b) test and refine an electronic data management system to collect and manage the data. Methods A maximum of 240 adults, meeting the Budapest diagnostic clinical criteria for CRPS type I or II, will be recruited across eight countries. The COMPACT questionnaire will be completed on two occasions: at baseline (T1) and 6 months later (T2). At T2, participants will choose to complete COMPACT using a paper or electronic version. Participants will be asked to feed back on their experience of completing COMPACT via a questionnaire. A separate questionnaire will ask clinicians to feed back their experience of data collection. Analysis The study is not aiming to derive statistically significant data but to ascertain the practicalities of collecting data, using the COMPACT questionnaire set, across a range of different cultures and populations. At the end of the study, a single workshop will be convened to review the findings and agree the final documents and processes for the international registry.

Background Published guidelines promote best practice in complex regional pain syndrome (CRPS) treatment and management; however, these recommendations are not always applied in clinical practice. Understanding existing care internationally will help inform future patient and health professional service delivery, education initiatives and content of clinical guidelines. Methods An e-survey was conducted in order to gain an insight into routine CRPS clinical practice. Health professionals and academics, from the field of CRPS, were recruited from an international population. Quantitative and qualitative data were elicited. Data were mapped onto a framework to identify macro-regional factors. Results Of the 260 survey respondents, 96% (n = 241) provided clinical care for people with CRPS, with academics not involved in patient care also responding. Half of respondents expressed difficulty in recognizing the symptoms of CRPS but treatment aims corresponded with published guidelines. However, a lack of resources and fragmented care were reported as barriers to early intervention. Service constraints were most frequently reported by European respondents. Five themes emerged from the qualitative data: the benefit of interdisciplinary working; the importance of symptom management; need for early diagnosis and intervention; establishing a collaborative partnership with patients; the value of education for patients and health professionals. Conclusions Our data suggest that more work is required to raise awareness of the Budapest CRPS diagnostic criteria so as to promote early diagnosis and intervention. Future work to optimize clinical effectiveness should consider enhancing interdisciplinary service delivery that encourages a collaborative patient/clinician partnership; includes excellent patient education; and addresses modifiable patient-related factors. Significance Health professionals expressed some level of difficulty recognizing the signs and symptoms of CRPS despite the majority of health professionals having had clinical experience exceeding 6 years in the field of CRPS. More work is required to raise awareness amongst clinicians of the Budapest CRPS diagnostic criteria so as to promote early diagnosis and intervention Health professionals' treatment aims reflected the current clinical guidelines however, a lack of resources and fragmented care were frequently cited as barriers to achieving these.

Objectives The purpose of this study was to conduct classical psychometric evaluation and Rasch analysis on the Neuropathic Qualities subscale of the Short-Form McGill Pain Questionnaire-2 utilizing scores from persons with complex regional pain syndrome to consider reliability and person separation, validity (including unidimensionality), and responsiveness in this population. Methods Secondary analysis of longitudinal data from persons with acute complex regional pain syndrome was utilized for analysis of the psychometric properties and fit to the Rasch model of the Neuropathic Qualities subscale. We followed an iterative process of Rasch analysis to evaluate and address data fitting challenges. Results Repeated measures from 59 persons meeting the Budapest criteria were used for analysis. Both item-total correlations and unidimensionality analyses supported theoretical construct validity; all convergent construct validity hypotheses were also supported. Responsiveness was demonstrated comparing baseline and one-year data at d=0.92, with a standardized response mean of 0.97. Data were able to fit the Rasch model, but all Neuropathic Qualities items had disordered thresholds that required rescoring. Additionally, local dependency and differential item function were addressed by bundling, suggesting that no further item reduction would be possible. Conclusions This study provided preliminary support for the validity and responsiveness of the Neuropathic Qualities subscale in persons with complex regional pain syndrome. Rasch analysis further endorses use of the Neuropathic Qualities subscale as a stand-alone measure for neuropathic features, but with substantial background data transformations. Replication with larger samples is recommended to increase confidence in these findings.

Background Sensorimotor conflicts are well known to induce sensory disturbances. However, explanations as to why patients with chronic pain are more sensitive to sensorimotor conflicts remain elusive. The main objectives of this study were (a) to assess and compare the sensory disturbances induced by sensorimotor conflict in complex regional pain syndrome (n = 38), fibromyalgia (n = 36), arthritis (n = 34) as well as in healthy volunteers (HV) (n = 32); (b) to assess whether these disturbances were related to the intensity and duration of pain, or to other clinical variables assessed using questionnaires (abnormalities in sensory perception, depression and anxiety); and (c) to categorize different subgroups of conflict-induced sensory disturbances. Methods One hundred and forty participants performed in phase or anti-phase movements with their arms while viewing a reflection of one arm in a mirror (and the other arm obscured). They were asked to report changes in sensory disturbances using a questionnaire. Results First, results showed that patients with complex regional pain syndrome and fibromyalgia were more prone to report sensory disturbances than arthritis patients and HV in response to conflicts (small effect size). Second, conflict-induced sensory disturbances were correlated with pain intensity (large effect size) and abnormalities in sensory perception (only in the CRPS group) but were not related to the duration of the disease or psychological factors. Finally, we identified two distinct subgroups of conflict-induced sensory disturbances. Conclusions Our results suggest that pain lowers the threshold for the detection of sensorimotor conflicts, a phenomenon that could contribute to the maintenance of pain in clinical populations. Significance: Individuals with complex regional pain syndrome and fibromyalgia were more sensitive to sensorimotor conflicts than arthritis patients and controls. Moreover, conflict-induced sensory disturbances were specific to higher pain intensity and higher sensory abnormalities in all groups, suggesting that pain lowers the threshold for the detection of sensorimotor conflicts.