Research delivery secondments: A scoping review.

AIM: To explore and summarise published literature with regards to secondments to clinical research and to identify the gaps in research to inform further work. DESIGN: Systematic scoping review. METHOD: A 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. RESULTS: Six 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. CONCLUSION: Published 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 PROFESSION: Undertaking 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. IMPACT: This 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 METHOD: The PRISMA-ScR guidelines were used to guide reporting. NO PATIENT OR PUBLIC CONTRIBUTION: This was not relevant to the research design.

An international study to explore the feasibility of collecting standardised outcome data for Complex Regional Pain Syndrome: recommendations for an international clinical research registry.

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.

The visibility of research within mandatory National Health Service Trust Induction programmes in England: an exploratory survey study.

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.

Participatory design of an infographic to help support the care of people living with complex regional pain syndrome.

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.

Sensory training system for use at home by people with complex regional pain syndrome in England: protocol for a proof-of-concept study.

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.

Resilience in patients with complex regional pain syndrome 1-a cross-sectional analysis of patients participating in a cross-sectional cohort study.

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.

Delphi study to define core clinical outcomes for inclusion in a complex regional pain syndrome international research registry and data bank.

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.

Complex Regional Pain Syndrome: Practical Diagnostic and Treatment Guidelines, 5th Edition.

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.

Complex regional pain syndrome: An international survey of clinical practice.

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.

A multi-centre study to explore the feasibility and acceptability of collecting data for complex regional pain syndrome clinical studies using a core measurement set: Study protocol.

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.

Sensory disturbances induced by sensorimotor conflicts are higher in complex regional pain syndrome and fibromyalgia compared to arthritis and healthy people, and positively relate to pain intensity.

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.

Measurement Properties of the SF-MPQ-2 Neuropathic Qualities Subscale in Persons with CRPS: Validity, Responsiveness, and Rasch Analysis.

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.

Recommendations for a first Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies (COMPACT).

Complex regional pain syndrome (CRPS) is a persistent pain condition that remains incompletely understood and challenging to treat. Historically, a wide range of different outcome measures have been used to capture the multidimensional nature of CRPS. This has been a significant limiting factor in the advancement of our understanding of the mechanisms and management of CRPS. In 2013, an international consortium of patients, clinicians, researchers, and industry representatives was established, to develop and agree on a minimum core set of standardised outcome measures for use in future CRPS clinical research, including but not limited to clinical trials within adult populations. The development of a core measurement set was informed through workshops and supplementary work, using an iterative consensus process. "What is the clinical presentation and course of CRPS, and what factors influence it?" was agreed as the most pertinent research question that our standardised set of patient-reported outcome measures should be selected to answer. The domains encompassing the key concepts necessary to answer the research question were agreed as follows: pain, disease severity, participation and physical function, emotional and psychological function, self-efficacy, catastrophizing, and patient's global impression of change. The final core measurement set included the optimum generic or condition-specific patient-reported questionnaire outcome measures, which captured the essence of each domain, and 1 clinician-reported outcome measure to capture the degree of severity of CRPS. The next step is to test the feasibility and acceptability of collecting outcome measure data using the core measurement set in the CRPS population internationally.

'What I Really Needed Was the Truth'. Exploring the Information Needs of People with Complex Regional Pain Syndrome.

BACKGROUND: UK guidelines indicate that individuals with complex regional pain syndrome (CRPS) require information and education to support self-management. The present qualitative study explored the specific information requirements of patients with CRPS and provides insight into how health professionals can best provide this. METHODS: Following informed consent, eight semi-structured telephone interviews were conducted with adults living with CRPS. Participants were asked about their experience of receiving information since diagnosis and the information that they would prefer to receive. Interviews were transcribed and data analysed using thematic analysis. RESULTS: Two themes related to individuals' experience of receiving information. These were: 'Facing the unknown', which describes how participants reported that little information was available and the impact of this; and 'The need to be an expert', which describes how they needed to be proactive to seek this information themselves. Three themes related to the information that the individual would choose to receive. These were: 'Seeking the truth', which describes the need for knowledge - particularly accurate, honest information; 'The shared experience', which describes the positive and negative aspects of sharing information with others experiencing CRPS; and 'Access to expertise', which describes the need for access to reliable information, resources and expertise. CONCLUSION: The reported lack of information resulted in a struggle for participants to understand their condition, and access professional expertise and appropriate treatments. Health professionals require access to accurate information in order to share this with individuals with CRPS in a timely manner. Easily accessible and high-quality patient resources to facilitate early referral for expertise are required. A central resource to identify local expertise would be valuable.

Evaluation of a prototype tool for communicating body perception disturbances in complex regional pain syndrome.

Patients with Complex Regional Pain Syndrome (CRPS) experience distressing changes in body perception. However representing body perception is a challenge. A digital media tool for communicating body perception disturbances was developed. A proof of concept study evaluating the acceptability of the application for patients to communicate their body perception is reported in this methods paper. Thirteen CRPS participants admitted to a 2-week inpatient rehabilitation program used the application in a consultation with a research nurse. Audio recordings were made of the process and a structured questionnaire was administered to capture experiences of using the tool. Participants produced powerful images of disturbances in their body perception. All reported the tool acceptable for communicating their body perception. Participants described the positive impact of now seeing an image they had previously only imagined and could now convey to others. The application has provided a novel way for communicating perceptions that are otherwise difficult to convey.