Publications by authors named "Paul Chadwick"

98 Publications

Why? What? How? Using an Intervention Mapping approach to develop a personalised intervention to improve adherence to photoprotection in patients with Xeroderma Pigmentosum.

Health Psychol Behav Med 2020 Oct 27;8(1):475-500. Epub 2020 Oct 27.

Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.

Intervention Mapping (IM) is a systematic approach for developing theory-based interventions across a variety of contexts and settings. This paper describes the development of a complex intervention designed to reduce the dose of ultraviolet radiation (UVR) reaching the face of adults with Xeroderma Pigmentosum (XP), by improving photoprotection. XP is a genetic condition that without extreme UVR photoprotection, leads to high risk of developing skin cancer. : The IM protocol of 6 steps was applied, involving comprehensive mixed-methods formative research. Key stakeholders (XP clinical staff and Patient and Public Involvement Panel), were instrumental at every step. Behaviour change methods were informed by the IM taxonomy, therapeutic approaches (e.g. ACT, CBT) and coded according to the taxonomy of behaviour change techniques (version 1). We designed a personalised modular intervention to target psychosocial determinants of photoprotective activities that influence the amount of UVR reaching the face. Content was developed to target determinants of motivation to protect and factors preventing the enactment of behaviours. Participants received personalised content addressing determinants/barriers most relevant to them, as well as core 'behaviour-change' material, considered important for all (e.g. SMART goals). Core and personalised content was delivered via 7 one-to-one sessions with a trained facilitator using a manual and purpose designed materials: Magazine; text messages; sunscreen application video; goal-setting tools (e.g. UVR dial and face protection guide); activity sheets. Novel features included use of ACT-based values to enhance intrinsic motivation, targeting of emotional barriers to photoprotection, addressing appearance concerns and facilitating habit formation. : IM was an effective approach for complex intervention design. The structure (e.g. use of matrices) tethered the intervention tightly to theory and evidence-based approaches. The significant amount of time required needs to be considered and may hinder translation of IM into clinical and non-academic settings.
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http://dx.doi.org/10.1080/21642850.2020.1819287DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8114411PMC
October 2020

Need for care, adversity exposure and perceived stress in clinical and healthy voice-hearers - Corrigendum.

Psychol Med 2021 Apr 5. Epub 2021 Apr 5.

Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.

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http://dx.doi.org/10.1017/S0033291721000696DOI Listing
April 2021

The DAFNEplus programme for sustained type 1 diabetes self management: Intervention development using the Behaviour Change Wheel.

Diabet Med 2021 May 10;38(5):e14548. Epub 2021 Mar 10.

Clinical, Health and Educational Psychology/Centre for Behaviour Change, University College London, London, United Kingdom of Great Britain and Northern Ireland.

Aims: Self-management programmes for type 1 diabetes, such as the UK's Dose Adjustment for Normal Eating (DAFNE), improve short-term clinical outcomes but difficulties maintaining behavioural changes attenuate long-term impact. This study used the Behaviour Change Wheel (BCW) framework to revise the DAFNE intervention to support sustained behaviour change.

Methods: A four-step method was based on the BCW intervention development approach: (1) Identifying self-management behaviours and barriers/enablers to maintain them via stakeholder consultation and evidence synthesis, and mapping barriers/enablers to the Capability, Opportunity, Motivation-Behaviour (COM-B) model. (2) Specifying behaviour change techniques (BCTs) in the existing DAFNE intervention using the Behaviour Change Techniques Taxonomy (BCTTv1). (3) Identifying additional BCTs to target the barriers/enablers using the BCW and BCTTv1. (4) Parallel stakeholder consultation to generate recommendations for intervention revision. Revised materials were co-designed by stakeholders (diabetologists, psychologists, specialist nurses and dieticians).

Results: In all, 34 barriers and 5 enablers to sustaining self-management post-DAFNE were identified. The existing DAFNE intervention contained 24 BCTs, which partially addressed the enablers. In all, 27 BCTs were added, including 'Habit formation', 'Credible source' and 'Conserving mental resources'. In total, 15 stakeholder-agreed recommendations for content and delivery were incorporated into the final DAFNEplus intervention, comprising three co-designed components: (1) face-to-face group learning course, (2) individual structured follow-up sessions and (3) technological support, including blood glucose data management.

Conclusions: This method provided a systematic approach to specifying and revising a behaviour change intervention incorporating stakeholder input. The revised DAFNEplus intervention aims to support the maintenance of behavioural changes by targeting barriers and enablers to sustaining self-management behaviours.
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http://dx.doi.org/10.1111/dme.14548DOI Listing
May 2021

People with psychosis improve affective social cognition and self-care after a mindfulness-based social cognition training program (SocialMIND).

Psychiatr Rehabil J 2021 Feb 11. Epub 2021 Feb 11.

Hospital La Paz Institute for Health Research (IdiPAZ), Neuroscience Research Area.

Objective: This study explores whether social cognition and social functioning improve after a mindfulness-based social cognition training (SocialMIND).

Methods: Thirty-eight outpatients with psychosis completed an assessment with social cognition (Eyes Test, Ambiguous Intentions and Hostility Questionnaire [AIHQ], and Hinting Task) and social functioning tasks (Personal and Social Performance [PSP] scale) before and after eight SocialMIND weekly sessions. Mean differences between timepoints were standardized and 95% confidence intervals were obtained with a paired samples t-test.

Results: The scores of the Eyes Test (95% CI [.43, 3.32], d = .48), the Hostility Bias subscale (AIHQ) (95% CI [-.29, -.01], d = .44), and the self-care difficulties subscale (PSP) (95% CI [-.77, -.09], d = .45) improved after the intervention.

Conclusions: and Implications for practice: The results of SocialMIND-8 are very promising in terms of developing comprehensive rehabilitation programs. Further trials must address its effectiveness against a control group during longer follow-up periods. (PsycInfo Database Record (c) 2021 APA, all rights reserved).
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http://dx.doi.org/10.1037/prj0000466DOI Listing
February 2021

Protocol for a cluster randomised controlled trial of the DAFNE (Dose Adjustment For Normal Eating) intervention compared with 5x1 DAFNE: a lifelong approach to promote effective self-management in adults with type 1 diabetes.

BMJ Open 2021 01 18;11(1):e040438. Epub 2021 Jan 18.

Northumbria Healthcare NHS Foundation Trust, North Shields, UK.

Introduction: The successful treatment of type 1 diabetes (T1D) requires those affected to employ insulin therapy to maintain their blood glucose levels as close to normal to avoid complications in the long-term. The Dose Adjustment For Normal Eating (DAFNE) intervention is a group education course designed to help adults with T1D develop and sustain the complex self-management skills needed to adjust insulin in everyday life. It leads to improved glucose levels in the short term (manifest by falls in glycated haemoglobin, HbA1c), reduced rates of hypoglycaemia and sustained improvements in quality of life but overall glucose levels remain well above national targets. The DAFNE intervention is a development of DAFNE designed to incorporate behavioural change techniques, technology and longer-term structured support from healthcare professionals (HCPs).

Methods And Analysis: A pragmatic cluster randomised controlled trial in adults with T1D, delivered in diabetes centres in National Health Service secondary care hospitals in the UK. Centres will be randomised on a 1:1 basis to standard DAFNE or DAFNE. Primary clinical outcome is the change in HbA1c and the primary endpoint is HbA1c at 12 months, in those entering the trial with HbA1c >7.5% (58 mmol/mol), and HbA1c at 6 months is the secondary endpoint. Sample size is 662 participants (approximately 47 per centre); 92% power to detect a 0.5% difference in the primary outcome of HbA1c between treatment groups. The trial also measures rates of hypoglycaemia, psychological outcomes, an economic evaluation and process evaluation.

Ethics And Dissemination: Ethics approval was granted by South West-Exeter Research Ethics Committee (REC ref: 18/SW/0100) on 14 May 2018. The results of the trial will be published in a National Institute for Health Research monograph and relevant high-impact journals.

Trial Registration Number: ISRCTN42908016.
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http://dx.doi.org/10.1136/bmjopen-2020-040438DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7813353PMC
January 2021

Positive schizotypy and the experience of creativity: The distinctive roles of suspiciousness and dispositional mindfulness.

Schizophr Res 2021 02 11;228:151-158. Epub 2021 Jan 11.

Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK; Division of Psychology, Department of Life Sciences and Centre for Cognitive Neuroscience, College of Health and Life Sciences, Brunel University London, UK. Electronic address:

Positive schizotypy has been shown to predict emergence of schizophrenia-spectrum disorders, with suspiciousness/paranoia regarded a key risk factor. However, magical thinking and unusual perceptual experiences, other aspects of positive schizotypy, are associated with creativity. We investigated whether suspiciousness attenuates the relationship of magical thinking and unusual experiences with creative experience, and explored the interaction of dispositional mindfulness with positive schizotypy and creative experience. 342 (256 females) healthy adults (mean age: 25.9; SD 8.4) completed online self-report measures of schizotypy, creative experience, and dispositional mindfulness. Moderation analysis showed that suspiciousness attenuated the positive relationship of magical thinking (b = -0.29, p = .03) and unusual perceptual experiences (b = -0.23, p = .01) with an aspect of creative experience related to positive affect - power/pleasure. This effect was not present for 4 other aspects of creative experience. Multiple linear regressions revealed higher dispositional mindfulness to interact with aspects of positive schizotypy associated with heightened creative experience of power/pleasure (b = 0.06, p = .03), clarity/preparation (b = 0.03, p = .004), and differing levels of anxiety associated with creative engagement (b = -0.06, p = .003; b = 0.03, p = .047). Higher dispositional mindfulness was also associated with lower suspiciousness (r = -0.33, p < .001). The study highlights the importance of considering the role of suspiciousness/paranoia when investigating the relationship between positive schizotypy and creativity. The findings provide support for the application of mindfulness-based interventions for mitigating psychosis-risk associated with suspiciousness, whilst supporting the otherwise favourable association of positive schizotypy with creativity.
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http://dx.doi.org/10.1016/j.schres.2020.12.004DOI Listing
February 2021

A commentary on podiatry during the Covid-19 pandemic : Podiatry during the Covid-19 pandemic.

J Foot Ankle Res 2020 Oct 15;13(1):63. Epub 2020 Oct 15.

Manchester Local Care Organisation, Manchester, UK.

Background: The arrival of the novel coronavirus (SARS-CoV-2) has impacted the many aspects of modern life, especially, in the immediate term, the delivery of healthcare.

Context: This commentary examines the profession of podiatry and how it has adapted and responded to the emerging crisis. It focusses on but is not exclusive to the position in the United Kingdom (UK) and the edicts and direction from the UK Government.

Podiatry Roles During The Pandemic: It describes the role of podiatry in the pandemic and highlights the deployment of podiatry resources to fight the pandemic beyond traditional podiatric practice. It also looks at the shift from conventional consultation to digital solutions for managing patients in an effort to achieve the goals of maintenance of foot health whilst reducing the spread of the virus. The commentary summarises the emerging data related to a possible foot related presentation of the coronavirus.

Conclusion: The podiatry profession proved its flexibility and adaptability during the pandemic, to adjust rapidly to ensure that patients were able to access treatment to reduce risk of infection, ulceration and amputation. Dermatological presentations on the feet have been associated with Covid-19 in adolescents as is often the case in viral infections. CPD webinars to support clinicians and manage and prevent the spread of Covid-19 have been widely disseminated along with algorithms to ensure that patients that need treatment are being treated appropriately. Podiatrists have embraced remote technology to ensure that patients are correctly and safely triaged and, signposted and given appropriate self-care advice. MSK podiatrists have the ability to play an intrinsic role within the post discharge rehabilitation pathway.
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http://dx.doi.org/10.1186/s13047-020-00425-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7561248PMC
October 2020

Need for care, adversity exposure and perceived stress in clinical and healthy voice-hearers.

Psychol Med 2020 Jul 20:1-7. Epub 2020 Jul 20.

Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.

Objectives: Psychosis, and in particular auditory verbal hallucinations (AVHs), are associated with adversity exposure. However, AVHs also occur in populations with no need for care or distress.

Aims: This study investigated whether adversity exposure would differentiate clinical and healthy voice-hearers within the context of a 'three-hit' model of vulnerability and stress exposure.

Methods: Samples of 57 clinical and 45 healthy voice-hearers were compared on the three 'hits': familial risk; adversity exposure in childhood and in adolescence/adulthood.

Results: Clinical voice-hearers showed greater familial risk than healthy voice-hearers, with more family members with a history of psychosis, but not with other mental disorders. The two groups did not differ in their exposure to adversity in childhood [sexual and non-sexual, victimisation; discrimination and socio-economic status (SES)]. Contrary to expectations, clinical voice-hearers did not differ from healthy voice-hearers in their exposure to victimisation (sexual/non-sexual) and discrimination in adolescence/adulthood, but reported more cannabis and substance misuse, and lower SES.

Conclusions: The current study found no evidence that clinical and healthy voice-hearers differ in lifetime victimisation exposure, suggesting victimisation may be linked to the emergence of AVHs generally, rather than need-for-care. Familial risk, substance misuse and lower SES may be additional risk factors involved in the emergence of need-for-care and distress.
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http://dx.doi.org/10.1017/S0033291720002433DOI Listing
July 2020

Exclusively Digital Health Interventions Targeting Diet, Physical Activity, and Weight Gain in Pregnant Women: Systematic Review and Meta-Analysis.

JMIR Mhealth Uhealth 2020 07 10;8(7):e18255. Epub 2020 Jul 10.

University College London, London, United Kingdom.

Background: Interventions to promote a healthy diet, physical activity, and weight management during pregnancy are increasingly embracing digital technologies. Although some interventions have combined digital with interpersonal (face-to-face or telephone) delivery, others have relied exclusively on digital delivery. Exclusively digital interventions have the advantages of greater cost-effectiveness and broader reach and as such can be a valuable resource for health care providers.

Objective: This systematic review aims to focus on exclusively digital interventions to determine their effectiveness, identify behavior change techniques (BCTs), and investigate user engagement.

Methods: A total of 6 databases (Medical Literature Analysis and Retrieval System Online [MEDLINE], Excerpta Medica dataBASE [EMBASE], PsycINFO, Cumulated Index to Nursing and Allied Health Literature [CINAHL] Plus, Web of Science, and ProQuest) were searched for randomized controlled trials or pilot control trials of exclusively digital interventions to encourage healthy eating, physical activity, or appropriate weight gain during pregnancy. The outcome measures were gestational weight gain (GWG) and changes in physical activity and dietary behaviors. Study quality was assessed using the Cochrane Risk of Bias tool 2.0. Where possible, pooled effect sizes were calculated using a random effects meta-analysis.

Results: In total, 11 studies met the inclusion criteria. The risk of bias was mostly high (n=5) or moderate (n=3). Of the 11 studies, 6 reported on GWG as the primary outcome, 4 of which also measured changes in physical activity and dietary behaviors, and 5 studies focused either on dietary behaviors only (n=2) or physical activity only (n=3). The meta-analyses showed no significant benefit of interventions on total GWG for either intention-to-treat data (-0.28 kg; 95% CI -1.43 to 0.87) or per-protocol data (-0.65 kg; 95% CI -1.98 to 0.67). Substantial heterogeneity in outcome measures of change in dietary behaviors and physical activity precluded further meta-analyses. BCT coding identified 7 BCTs that were common to all effective interventions. Effective interventions averaged over twice as many BCTs from the goals and planning, and feedback and monitoring domains as ineffective interventions. Data from the 6 studies reporting on user engagement indicated a positive association between high engagement with key BCTs and greater intervention effectiveness. Interventions using proactive messaging and feedback appeared to have higher levels of engagement.

Conclusions: In contrast to interpersonal interventions, there is little evidence of the effectiveness of exclusively digital interventions to encourage a healthy diet, physical activity, or weight management during pregnancy. In this review, effective interventions used proactive messaging, such as reminders to engage in BCTs, feedback on progress, or tips, suggesting that interactivity may drive engagement and lead to greater effectiveness. Given the benefits of cost and reach of digital interventions, further research is needed to understand how to use advancing technologies to enhance user engagement and improve effectiveness.
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http://dx.doi.org/10.2196/18255DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7382015PMC
July 2020

Group mindfulness-based therapy for persecutory delusions: A pilot randomised controlled trial.

Schizophr Res 2020 08 10;222:534-536. Epub 2020 May 10.

Department of Psychology, University of Bath, United Kingdom of Great Britain and Northern Ireland. Electronic address:

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http://dx.doi.org/10.1016/j.schres.2020.04.023DOI Listing
August 2020

Mindfulness-based crisis interventions (MBCI) for psychosis within acute inpatient psychiatric settings; a feasibility randomised controlled trial.

BMC Psychiatry 2020 04 29;20(1):193. Epub 2020 Apr 29.

Department of Psychology, King's College London, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), De Crespigny Park, London, SE5 8AF, UK.

Background: Inpatient psychiatric care is a scarce and expensive resource in the National Health Service (NHS), with chronic bed shortages being partly driven by high re-admission rates. Brief inpatient talking therapies for psychosis could help reduce re-admission rates. The primary aim was to assess feasibility and acceptability of a novel, brief, mindfulness-based intervention for inpatients with psychosis. The secondary aim was to collect pilot outcome data on readmission rate, at 6 and 12 months (m) post discharge, and self-report symptom measures at 6 m.

Methods: The amBITION study (BrIef Talking therapIes ON wards) was a parallel group, feasibility randomised controlled trial (RCT). In addition to treatment as usual (TAU), eligible inpatients with psychotic symptoms were randomly allocated to receive either (Mindfulness-Based Crisis Intervention; MBCI) or a control intervention (Social Activity Therapy; SAT), for 1-5 sessions.

Results: Fifty participants were recruited (26 MBCI; 24 SAT); all received at least 1 therapy session (mean = 3). Follow-up rates were 98% at 6 m and 96% at 12 m for service use data extracted from clinical notes, and 86% for self-report measures. At 6 m follow-up, re-admission rates were similar across groups (MBCI = 6, SAT = 5; odds ratio = 1.20, 95% CI: 0.312-4.61). At 12 m follow-up, re-admissions were lower in the MBCI group (MBCI = 7, SAT = 11; odds ratio = 0.46, 95% CI: 0.14-1.51). Three participants experienced adverse events; none was related to trial participation.

Conclusions: Delivering a brief mindfulness-based inpatient intervention for psychosis is feasible and acceptable, and may reduce risk of short-term readmission. These promising findings warrant progression to a larger clinical effectiveness trial.

Trial Registration: ISRCTN37625384.
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http://dx.doi.org/10.1186/s12888-020-02608-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7191699PMC
April 2020

Multiple Interventions for Diabetic Foot Ulcer Treatment Trial (MIDFUT): study protocol for a randomised controlled trial.

BMJ Open 2020 04 19;10(4):e035947. Epub 2020 Apr 19.

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.

Introduction: Diabetes affects more than 425 million people worldwide with a lifetime risk of diabetic foot ulcer (DFU) of up to 25%. Management includes wound debridement, wound dressings, offloading, treatment of infection and ischaemia, optimising glycaemic control; use of advanced adjuvant therapies is limited by high cost and lack of robust evidence.

Methods And Analysis: A multicentre, seamless phase II/III, open, parallel group, multi-arm multi-stage randomised controlled trial in patients with a hard-to-heal DFU, with blinded outcome assessment. A maximum of 447 participants will be randomised (245 participants in phase II and 202 participants in phase III). The phase II primary objective will determine the efficacy of treatment strategies including hydrosurgical debridement ± decellularised dermal allograft, or the combination with negative pressure wound therapy, as an adjunct to treatment as usual (TAU), compared with TAU alone, with patients randomised in a 1:1:1:2 allocation. The outcome is achieving at least 50% reduction in index ulcer area at 4 weeks post randomisation.The phase III primary objective will determine whether one treatment strategy, continued from phase II, reduces time to healing of the index ulcer compared with TAU alone, with participants randomised in a 1:1 allocation. Secondary objectives will compare healing status of the index ulcer, infection rate, reulceration, quality of life, cost-effectiveness and incidence of adverse events over 52 weeks post randomisation. Phase II and phase III primary endpoint analysis will be conducted using a mixed-effects logistic regression model and Cox proportional hazards regression, respectively. A within-trial economic evaluation will be undertaken; the primary economic analysis will be a cost-utility analysis presenting ICERs for each treatment strategy in rank order of effectiveness, with effects expressed as quality-adjusted life years.The trial has predefined progression criteria for the selection of one treatment strategy into phase III based on efficacy, safety and costs at 4 weeks.

Ethics And Dissemination: Ethics approval has been granted by the National Research Ethics Service (NRES) Committee Yorkshire and The Humber - Bradford Leeds Research Ethics Committee; approved 26 April 2017; (REC reference: 17/YH/0055). There is planned publication of a monograph in National Institute for Health Research journals and main trial results and associated papers in high-impact peer-reviewed journals.

Trial Registration Number: ISRCTN64926597; registered on 6 June 2017.
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http://dx.doi.org/10.1136/bmjopen-2019-035947DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7245399PMC
April 2020

Infective Endocarditis in Patients With Intestinal Failure: Experience From a National Referral Center.

JPEN J Parenter Enteral Nutr 2021 02 13;45(2):309-317. Epub 2020 Apr 13.

Intestinal Failure Unit, Salford Royal Foundation Trust, Salford, UK.

Background: Infective endocarditis (IE) is a recognized complication of central line-associated bloodstream infection (CLABSI). Central venous access devices (CVADs) are essential for the delivery of long-term parenteral nutrition (PN), yet there are no published data as to the prevalence, characteristics and outcomes of IE in this population.

Methods: A prospectively maintained database of patients with intestinal failure (IF) types 2 and 3, managed by a national intestinal failure center between January 2010 and December 2018, was analyzed retrospectively and relevant factors extracted from case records.

Results: A total of 745 patients with IF and CVADs in situ on admission, or placed during their stay, were admitted over the duration of this study, 640 with type 2 IF and 105 with type 3 IF. Two hundred eighty-two echocardiograms were performed to investigate potential IE associated with a CLABSI event. Four cases of IE were identified in the entire cohort of 782,666 catheter days (IE incidence rate: 0.005 per 1000 catheter days and 187 per 100,000 person-years for the entire cohort; 0.048 per 1000 inpatient catheter days for acute type 2 IF, 0.0026 per 1000 outpatient catheter days [ie, 99 per 100,000 person-years for outpatients with type 3 IF]).

Conclusion: IE is rare in the type 3 IF population and a rare consequence of CLABSI in inpatient acute type 2 IF. However, mortality and morbidity are high. Routine echocardiography may not be warranted for investigation of CLABSI unless there is a high risk of IE or a virulent organism is involved.
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http://dx.doi.org/10.1002/jpen.1828DOI Listing
February 2021

Cost-effectiveness of superabsorbent wound dressing versus standard of care in patients with moderate-to-highly exuding leg ulcers.

J Wound Care 2020 Apr;29(4):235-246

Hartmann Group, Heidenheim, Germany.

Objective: To determine the cost-effectiveness/utility of a superabsorbent wound dressing (Zetuvit Plus Silicone) versus the current standard of care (SoC) dressings, from the NHS perspective in England, in patients with moderate-to-high exudating leg ulcers.

Method: A model-based economic evaluation was conducted to analyse the cost-effectiveness/utility of a new intervention. We used a microsimulation state-transition model with a time horizon of six months and a cycle length of one week. The model uses a combination of incidence base and risk prediction approach to inform transition probabilities. All clinical efficiency, health-related quality of life (HRQoL), cost and resource use inputs were informed by conducting a systematic review of UK specific literature.

Results: Treatment with the superabsorbent dressing leads to a total expected cost per patient for a six month period of £2887, associated with 15.933 expected quality adjusted life weeks and 10.9% healing rate. When treated with SoC, the total expected cost per patient for a six month period is £3109, 15.852 expected quality adjusted life weeks and 8% healing rate. Therefore, the superabsorbent dressing leads to an increase in quality-adjusted life weeks, an increase in healing rate by 2.9% and a cost-saving of £222 per single average patient over six months. Results of several scenario analyses, one-way deterministic sensitivity analysis, and probabilistic sensitivity analysis confirmed the robustness of base-case results. The probabilistic analysis confirmed that, in any combination of variable values, the superabsorbent dressing leads to cost saving results.

Conclusion: According to the model prediction, the superabsorbent dressing leads to an increase in health benefits and a decrease in associated costs of treatment.
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http://dx.doi.org/10.12968/jowc.2020.29.4.235DOI Listing
April 2020

Evaluation of a superabsorbent wound dressing, patient and clinician perspective: a case series.

J Wound Care 2020 Mar;29(3):174-182

7 Luna Consultants.

Objective: The primary objective of this study was to evaluate the fluid management capabilities of a superabsorbent wound dressing (Zetuvit Plus Silicone), with secondary objectives related to parameters that support whether the dressing enables undisturbed healing.

Method: This study was an open labelled non-comparative study. Patients included in the study were selected by the clinical investigator(s) according to whether the patient required a dressing for the management of moderately to highly exuding wounds.

Results: A total of 50 patients were included in the study. Results related to the primary objective demonstrated that the superabsorbent wound dressing was able to absorb all levels of exudate across the range (low to high). At each assessment time point these results show that in 98% of assessments the superabsorbent dressing was rated as 'very good' (91%) or 'good' (7%) at exudate management. Secondary objectives relating to wound bed preparation, healing and management of pain were also positive. Additionally, at the end of each patient treatment, the dressing's fluid management capabilities were rated overall as 'excellent' (100% of cases). There was little pain associated with the wound or at dressing change throughout the study and its flexibility/conformability allowed for comfort and patient satisfaction aligned with increased quality of life. Additionally, inclusion of a silicone adhesive layer allowed painless and atraumatic removal of the dressing, increasing patient comfort, both during wear and at dressing removal, and supported the description of enabling undisturbed wound healing.

Conclusion: The superabsorbent wound dressing achieved the primary objective relating to wound exudate management in all the assessments undertaken in this study. In addition, the silicone interface allowed for undisturbed healing as evidenced by little or no adherence of the dressing to underlying tissue, preventing damage to periwound skin. Overall, the superabsorbent wound dressing with the addition of the silicone interface could offer advantages over other superabsorbent polymer dressings (that might adhere to the wound surface) or silicone wound dressings (that might not have the absorbent properties of this type of dressing).
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http://dx.doi.org/10.12968/jowc.2020.29.3.174DOI Listing
March 2020

Diagnosis and management of catheter-related bloodstream infections in patients on home parenteral nutrition.

Frontline Gastroenterol 2020 Jan 12;11(1):48-54. Epub 2019 Feb 12.

Intestinal Failure Unit, Salford Royal NHS Foundation Trust, Salford, UK.

Catheter-related bloodstream infections (CRBSIs) commonly arise from a parenteral nutrition catheter hub. A target for a Nutrition Support Team is to have a CRBSI rate of less than 1 per 1000. The diagnosis of CRBSI is suspected clinically by a temperature shortly after setting up a feed, general malaise or raised blood inflammatory markers. It is confirmed by qualitative and quantitative blood cultures from the catheter and peripherally. Treatment of inpatients may involve central venous catheter removal and antibiotics for patients needing short-term parenteral nutrition, but catheter salvage is generally recommended for patients needing long-term parenteral nutrition, where appropriate.
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http://dx.doi.org/10.1136/flgastro-2018-101094DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6914297PMC
January 2020

Sensitivity of differential time to positivity compared to pour plates for diagnosing catheter-related blood stream infection: An evaluation in patients with chronic intestinal failure.

Clin Nutr 2020 08 30;39(8):2631-2633. Epub 2019 Nov 30.

Intestinal Failure Unit, Salford Royal NHS Foundation Trust, Salford, M6 8HD, UK; School of Medical Science, University of Manchester, Manchester, UK.

Background & Aims: A retrospective evaluation was undertaken in intestinal failure (IF) patients with long term CVCs to evaluate differential time to positivity (DTP) against paired quantitative blood cultures (PP) for the diagnosis of CRBSI.

Methods: A list of patients with a diagnosis of CRBSI was obtained from the intestinal failure unit database for a five year period, 2013 to 2017. Microbiology records were reviewed to obtain further information about blood culture and pour plate examinations. Organisms and times of collection, loading and positivity were recorded. Patients with a contemporaneous set of central and peripheral PP and blood cultures were included in an analysis of the sensitivity of DTP compared to PP.

Results: There were 61 (45.5%) episodes in 56 patients where complete sets of central and peripheral blood cultures and PP were received. All 61 episodes had positive central blood cultures, 59 (96.7%) had positive central line PP and 17 (27.9%) had positive peripheral PP. Using PP as the gold standard, DTP sensitivity was 96.0% for 50 episodes where PP were consistent with CRBSI. Sensitivity increased to 100% for 17 episodes where there were no delays in either collection or loading of blood cultures.

Conclusions: This is the first evaluation to support the use of DTP as a sensitive test in diagnosing CRBSI in patients with IF and provides confidence to IF centers where pour plate cultures are not available.
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http://dx.doi.org/10.1016/j.clnu.2019.11.034DOI Listing
August 2020

Mindfulness for psychosis: a humanising therapeutic process.

Authors:
Paul Chadwick

Curr Opin Psychol 2019 08 18;28:317-320. Epub 2019 Jul 18.

Department of Psychology, University of Bath, UK. Electronic address:

Mindfulness for psychosis has been slow to develop, in part because of the fear and stigma that surrounds psychosis. Breakthrough research showing how to adapt mindfulness groups for people with current distressing psychosis has led to a growing research base and it is now clear that adapted mindfulness for psychosis is both safe and therapeutic. However, how it works is less clear. This article argues that at its heart is a core humanising therapeutic process, characterised by key metacognitive insights and increased acceptance both of psychotic experience and the self. This core therapeutic process is underpinned not only by commitment to mindfulness practice, but also through active, constructive engagement with the group process. Individuals discover that that they are more than the psychosis, and that the self is balanced (positive and negative) and changing. It is recommended that future research explores these intra-personal and inter-personal therapeutic processes alongside outcome trials.
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http://dx.doi.org/10.1016/j.copsyc.2019.07.022DOI Listing
August 2019

The effects of voice content on stress reactivity: A simulation paradigm of auditory verbal hallucinations.

Schizophr Res 2019 Aug 1. Epub 2019 Aug 1.

Institute of Psychiatry, Psychology & Neuroscience, King's College London, Department of Psychology, London, UK; Department of Psychology, University of Bath, Bath, UK.

Objectives: Psychosis is associated with increased subjective and altered endocrine and autonomic nervous system stress-reactivity. Psychosis patients often experience auditory verbal hallucinations, with negative voice content being particularly associated with distress. The present study developed a voice-simulation paradigm and investigated the effect of simulated voices with neutral and negative content on psychophysiological stress-reactivity, and the effect of mindful voice-appraisals on stress-reactivity.

Method: Eighty-four healthy participants completed the Montreal Imaging Stress Task with simultaneous presentation of one of three randomly allocated auditory stimuli conditions: negative voices, neutral voices or non-voice ambient sounds. Subjective stress-levels and mindful voice-appraisals were assessed using questionnaire measures, and cortisol and α-amylase levels were measured using saliva samples.

Results: ANOVA revealed a significant effect of condition on subjective stress-levels (p = .002), but not cortisol (p = .63) or α-amylase (p = .73). Post-hoc analyses showed that negative voices increased subjective stress-levels relative to neutral voices (p = .002) and ambient sounds (p = .01), which did not differ from each other (p = .41). Mindful voice-appraisals were associated with less distress across conditions (p = .003), although negative voices were also associated with less mindful appraisals (p < .001).

Conclusions: Negative voice content, rather than voices or auditory stimuli per se, is linked to greater subjective but not physiological stress-reactivity. Mindful appraisals may partially moderate this effect. These findings highlight the importance of voice content for the impact of voice-hearing, and highlight the potential value of mindfulness training to treat voice distress in psychosis.
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http://dx.doi.org/10.1016/j.schres.2019.07.019DOI Listing
August 2019

Bacterial-binding dressings in the management of wound healing and infection prevention: a narrative review.

J Wound Care 2019 Jun;28(6):370-382

Professor of Skin Integrity, Professor and Director of the Institute of Skin Integrity and Infection Prevention, Department of Nursing and Midwifery, University of Huddersfield.

The aim of this review was to present the clinical data on the use of the family of bacterial-binding dressings (Sorbact; dialkylcarbamoyl chloride-coated) in the treatment of a variety of acute and chronic wounds. The findings are discussed in terms of the effectiveness of the bacterial-binding dressings on bacterial bioburden reduction, infection prevention, initiation/progression of wound healing and cost-effectiveness. The evidence in support of the bacterial-binding dressings is strongest in the area of infection prevention in surgical wounds, with several controlled trials showing the prophylactic benefit of the dressing in these wounds. Wound bioburden management in chronic wounds is supported by a number of clinical studies. In total, 29 published clinical studies (with a total of 4044 patients) were included in this review.
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http://dx.doi.org/10.12968/jowc.2019.28.6.370DOI Listing
June 2019

The importance of acute kidney injury in suspected community acquired infection.

PLoS One 2019 7;14(5):e0216412. Epub 2019 May 7.

Renal Department, Salford Royal NHS Trust, Salford, United Kingdom.

Background: Most sepsis and acute kidney injury (AKI) cases are community acquired (CA). The aim of this study was to evaluate the characteristics of suspected community acquired infection (sCA-I) and CA-AKI and their impact upon patient outcomes.

Methods: All adult creatinine blood tests from non-elective, non-dialysis attendances to a single centre over a 29-month period were analysed retrospectively. We defined sCA-I and CA-AKI cases as antibiotic prescription and AKI alert within 48 hours of attendance respectively. Binary logistic regression models were created to determine associations with 30-day mortality, intensive care unit (ICU) admission and length of stay (LOS) dichotomised at median.

Results: Of 61,471 attendances 28.1% and 5.7% suffered sCA-I or CA-AKI in isolation respectively, 3.4% suffered both. sCA-I was present in 58.8% of CA-AKI cases and CA-AKI was present in 11.9% of CA-I cases. The combination of sCA-I and CA-AKI was associated with a higher risk for all outcomes compared to sCA-I or CA-AKI in isolation. The 30-day mortality was 8.1%, 11.8% and 26.2% in patients with sCA-I, CA-AKI and when sCA-I and CA-AKI occurred in combination respectively. The adjusted odds ratios (OR) and 95% confidence intervals (CI) for 30-day mortality, ICU admission and LOS for sCA-I combined with CA-AKI stage 1 were OR 6.09:CI: 5.21-7.12, OR 12.52 CI: 10.54-14.88 and OR 8.97 CI: 7.62-10.56, respectively, and for combined sCA-I and CA-AKI stage 3 were OR 9.23 CI: 6.91-12.33, OR 29.26 CI: 22.46-38.18 and OR 9.48 CI: 6.82-13.18 respectively.

Conclusion: The combination of sCA-I and CA-AKI is associated with worse outcomes.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0216412PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6504101PMC
January 2020

Measuring Plantar Tissue Stress in People With Diabetic Peripheral Neuropathy: A Critical Concept in Diabetic Foot Management.

J Diabetes Sci Technol 2019 09 29;13(5):869-880. Epub 2019 Apr 29.

9 Interdisciplinary Consortium on Advanced Motion Performance (iCAMP), Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, USA.

Excessive stress on plantar tissue over time is one of the leading causes of diabetic foot ulcers among people with diabetic peripheral neuropathy. Plantar tissue stress (PTS) is a concept that attempts to integrate several well-known mechanical factors into one measure, including plantar pressure, shear stress, daily weight-bearing activity, and time spent in prescribed offloading interventions (adherence). Despite international diabetic foot guidelines recommending the measure of each of these individual mechanical factors in people with neuropathy, only recently has technology enabled their combined measurement to determine PTS. In this article we review the concept of PTS, the mechanical factors involved, and the findings of pivotal articles reporting measures of PTS in people with neuropathy. We also discuss key existing gaps in this field, including the lack of standards to measure and report PTS, a lack of practical solutions to measure shear stress, and the lack of PTS thresholds that may indicate benefit or detriment to people with neuropathy. To address some of these gaps, we propose recommended clinical and research standards for measuring and reporting PTS in people with neuropathy. Last, we forecast future clinical, research, and technological advancements that may use PTS to highlight the importance of this critical concept in the prevention and management of diabetic foot ulcers.
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http://dx.doi.org/10.1177/1932296819849092DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6955461PMC
September 2019

Mindfulness for Psychosis Groups; Within-Session Effects on Stress and Symptom-Related Distress in Routine Community Care.

Behav Cogn Psychother 2019 Jul 18;47(4):421-430. Epub 2019 Jan 18.

King's College London,Institute of Psychiatry, Psychology and Neuroscience (IoPPN),Department of Psychology,London,UK.

Background: There is an emerging evidence base that mindfulness for psychosis is a safe and effective intervention. However, empirical data on the within-session effects of mindfulness meditation was hitherto lacking.

Aims: The aim of the study was to assess the impact of taking part in a mindfulness for psychosis group, using a within-session self-report measure of general stress, and symptom-related distress.

Method: Users of a secondary mental health service (n = 34), who experienced enduring psychotic symptoms, took part in an 8-week mindfulness for psychosis group in a community setting. Mindfulness meditations were limited to 10 minutes and included explicit reference to psychotic experience arising during the practice. Participants self-rated general stress, and symptom-related distress, before and after each group session using a visual analogue scale.

Results: Average ratings of general stress and symptom-related distress decreased from pre- to post-session for all eight sessions, although not all differences were statistically significant. There was no increase in general stress, or symptom-related distress across any session.

Conclusions: There was evidence of positive effects and no evidence of any harmful effects arising from people with psychotic symptoms taking part in a mindfulness for psychosis session.
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http://dx.doi.org/10.1017/S1352465818000723DOI Listing
July 2019

Adjunctive rifampicin to reduce early mortality from Staphylococcus aureus bacteraemia: the ARREST RCT.

Health Technol Assess 2018 10;22(59):1-148

Microbiology Department, Wirral University Teaching Hospital NHS Foundation Trust, Birkenhead, UK.

Background: bacteraemia is a common and frequently fatal infection. Adjunctive rifampicin may enhance early killing, sterilise infected foci and blood faster, and thereby reduce the risk of dissemination, metastatic infection and death.

Objectives: To determine whether or not adjunctive rifampicin reduces bacteriological (microbiologically confirmed) failure/recurrence or death through 12 weeks from randomisation. Secondary objectives included evaluating the impact of rifampicin on all-cause mortality, clinically defined failure/recurrence or death, toxicity, resistance emergence, and duration of bacteraemia; and assessing the cost-effectiveness of rifampicin.

Design: Parallel-group, randomised (1 : 1), blinded, placebo-controlled multicentre trial.

Setting: UK NHS trust hospitals.

Participants: Adult inpatients (≥ 18 years) with meticillin-resistant or susceptible grown from one or more blood cultures, who had received < 96 hours of antibiotic therapy for the current infection, and without contraindications to rifampicin.

Interventions: Adjunctive rifampicin (600-900 mg/day, oral or intravenous) or placebo for 14 days in addition to standard antibiotic therapy. Investigators and patients were blinded to trial treatment. Follow-up was for 12 weeks (assessments at 3, 7, 10 and 14 days, weekly until discharge and final assessment at 12 weeks post randomisation).

Main Outcome Measures: The primary outcome was all-cause bacteriological (microbiologically confirmed) failure/recurrence or death through 12 weeks from randomisation.

Results: Between December 2012 and October 2016, 758 eligible participants from 29 UK hospitals were randomised: 370 to rifampicin and 388 to placebo. The median age was 65 years [interquartile range (IQR) 50-76 years]. A total of 485 (64.0%) infections were community acquired and 132 (17.4%) were nosocomial; 47 (6.2%) were caused by meticillin-resistant . A total of 301 (39.7%) participants had an initial deep infection focus. Standard antibiotics were given for a median of 29 days (IQR 18-45 days) and 619 (81.7%) participants received flucloxacillin. By 12 weeks, 62 out of 370 (16.8%) patients taking rifampicin versus 71 out of 388 (18.3%) participants taking the placebo experienced bacteriological (microbiologically confirmed) failure/recurrence or died [absolute risk difference -1.4%, 95% confidence interval (CI) -7.0% to 4.3%; hazard ratio 0.96, 95% CI 0.68 to 1.35;  = 0.81]. There were 4 (1.1%) and 5 (1.3%) bacteriological failures ( = 0.82) in the rifampicin and placebo groups, respectively. There were 3 (0.8%) versus 16 (4.1%) bacteriological recurrences ( = 0.01), and 55 (14.9%) versus 50 (12.9%) deaths without bacteriological failure/recurrence ( = 0.30) in the rifampicin and placebo groups, respectively. Over 12 weeks, there was no evidence of differences in clinically defined failure/recurrence/death ( = 0.84), all-cause mortality ( = 0.60), serious ( = 0.17) or grade 3/4 ( = 0.36) adverse events (AEs). However, 63 (17.0%) participants in the rifampicin group versus 39 (10.1%) participants in the placebo group experienced antibiotic or trial drug-modifying AEs ( = 0.004), and 24 (6.5%) participants in the rifampicin group versus 6 (1.5%) participants in the placebo group experienced drug-interactions ( = 0.0005). Evaluation of the costs and health-related quality-of-life impacts revealed that an episode of bacteraemia costs an average of £12,197 over 12 weeks. Rifampicin was estimated to save 10% of episode costs ( = 0.14). After adjustment, the effect of rifampicin on total quality-adjusted life-years (QALYs) was positive (0.004 QALYs), but not statistically significant (standard error 0.004 QALYs).

Conclusions: Adjunctive rifampicin provided no overall benefit over standard antibiotic therapy in adults with bacteraemia.

Future Work: Given the substantial mortality, other antibiotic combinations or improved source management should be investigated.

Trial Registrations: Current Controlled Trials ISRCTN37666216, EudraCT 2012-000344-10 and Clinical Trials Authorisation 00316/0243/001.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 22, No. 59. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta22590DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6231058PMC
October 2018

Addressing childhood obesity in low-income, ethnically diverse families: outcomes and peer effects of MEND 7-13 when delivered at scale in US communities.

Int J Obes (Lond) 2019 01 3;43(1):91-102. Epub 2018 Aug 3.

Centre for Paediatric Epidemiology and Biostatistics, University College London, London, UK.

Objectives: Implementation of a large-scale, child weight management program in low-income, ethnically diverse communities provided an important opportunity to evaluate its effectiveness under service level conditions (i.e. provision as a primary care child weight management service).

Methods: MEND 7-13 is a community-based, multi-component, childhood obesity intervention designed to improve dietary, physical activity and sedentary behaviors. It comprises twice weekly sessions for 10 consecutive weeks (35 contact hours) and is delivered to groups of children and accompanying parents/caregivers. The evaluation used an uncontrolled, repeated measures design. Overall, 3782 children with overweight or obesity attended 415 MEND 7-13 programs in eight US states, of whom 2482 children (65.6%) had complete data for change in zBMI. The intervention targeted low-income, ethnically diverse families. Changes in anthropometric, cardiovascular fitness and psychological outcomes were evaluated. A longitudinal multivariate imputation model was used to impute missing data. Peer effects analysis was conducted using the instrumental variables approach and group fixed effects.

Results: Mean changes in BMI and zBMI at 10 weeks were -0.49 kg/m (95% CI: -0.67, -0.31) and -0.06 (95% CI: -0.08, -0.05), respectively. Benefits were observed for cardiovascular fitness and psychological outcomes. Mean peer reduction in zBMI was associated with a reduction in participant zBMI in the instrumental variables model (B = 0.78, P = 0.04, 95% CI: 0.03, 1.53). Mean program attendance and retention were 73.9% and 88.5%, respectively.

Conclusion: Implementing MEND 7-13 under service level conditions was associated with short-term improvements in anthropometric, fitness and psychological indices in a large sample of low-income, ethnically diverse children with overweight and obesity. A peer effect was quantified showing that benefits for an individual child were enhanced, if peers in the same group also performed well. To our knowledge, this is the first US study to evaluate outcomes of an up-scaled community-based, child weight management program and to show positive peer effects associated with participation in the intervention.
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http://dx.doi.org/10.1038/s41366-018-0158-2DOI Listing
January 2019

A systematic scoping review of psychological therapies for psychosis within acute psychiatric in-patient settings.

Br J Psychiatry 2018 08 26;213(2):490-497. Epub 2018 Jun 26.

Professor of Clinical Psychology and DClinPsy Programme Director,Department of Psychology,Institute of Psychiatry, Psychology and Neuroscience, King's College London,UK.

Background: People with psychotic disorders account for most acute admissions to psychiatric wards. Psychological therapies are a treatment adjunct to standard medication and nursing care, but the evidence base for such therapies within in-patient settings is unclear.AimsTo conduct a systematic scoping review of the current evidence base for psychological therapies for psychosis delivered within acute in-patient settings (PROSPERO: CRD42015025623).

Method: All study designs, and therapy models, were eligible for inclusion in the review. We searched PubMed, PsycINFO, EThOS, ProQuest, conference abstracts and trial registries.

Results: We found 65 studies that met criteria for inclusion in the review, 21 of which were randomised controlled trials (RCTs). The majority of studies evaluated cognitive-behavioural interventions. Quality was variable across all study types. The RCTs were mostly small (n<25 in the treatment arm), and many had methodological limitations including poorly described randomisation methods, inadequate allocation concealment and non-masked outcome assessments. We found studies used a wide range of different outcome measures, and relatively few studies reported affective symptoms or recovery-based outcomes. Many studies described adaptations to treatment delivery within in-patient settings, including increased frequency of sessions, briefer interventions and use of single-session formats.

Conclusions: Based on these findings, there is a clear need to improve methodological rigour within in-patient research. Interpretation of the current evidence base is challenging given the wide range of different therapies, outcome measures and models of delivery described in the literature.Declaration of interestNone.
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http://dx.doi.org/10.1192/bjp.2018.106DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6054872PMC
August 2018

Multicenter, randomized controlled, observer-blinded study of a nitric oxide generating treatment in foot ulcers of patients with diabetes-ProNOx1 study.

Wound Repair Regen 2018 03 17;26(2):228-237. Epub 2018 Jul 17.

Strategic Solutions, Inc., Cody, Wyoming.

The aim of this multicenter, prospective, observer-blinded, parallel group, randomized controlled trial was to assess the safety and efficacy of EDX110, a nitric oxide generating medical device, in the treatment of diabetic foot ulcers in a patient group reflecting "real world" clinical practice compared against optimal standard care. Participants were recruited from ten hospital sites in multidisciplinary foot ulcer clinics. The ulcers were full thickness, with an area of 25-2,500 mm and either a palpable pedal pulse or ankle brachial pressure index > 0.5. Infected ulcers were included. Treatment lasted 12 weeks, or until healed, with a 12-week follow-up period. Both arms were given optimal debridement, offloading and antimicrobial treatment, the only difference being the fixed used of EDX110 as the wound dressing in the EDX110 group. 135 participants were recruited with 148 ulcers (EDX110-75; Control-73), 30% of which were clinically infected at baseline. EDX110 achieved its primary endpoint by attaining a median Percentage Area Reduction of 88.6% compared to 46.9% for the control group (p = 0.016) at 12 weeks in the intention-to-treat population. There was no significant difference between wound size reduction achieved by EDX110 after 4 weeks and the wound size reduction achieved in the control group after 12 weeks. EDX110 was well tolerated. Thirty serious adverse events were reported (12 in the EDX110 group, of which 4 were related to the ulcer; 18 in the control group, of which 10 were related and 1 possibly related to the ulcer), with significant reduction in serious adverse events related to the ulcer in EDX group. There was no significant difference in adverse events. This study, in a real world clinical foot ulcer population, demonstrates the ability of EDX110 to improve healing, as measured by significantly reducing the ulcer area, compared to current best clinical practice.
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http://dx.doi.org/10.1111/wrr.12630DOI Listing
March 2018