Publications by authors named "Michael Stanton"

83 Publications

Recovery of foot drop in chronic inflammatory demyelinating polyneuropathy (CIDP).

Muscle Nerve 2021 Apr 20. Epub 2021 Apr 20.

Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.

Introduction/aims: Foot drop is common in chronic inflammatory demyelinating polyneuropathy (CIDP), but its prognosis is uncertain.

Methods: CIDP patients with less than anti-gravity strength (<3/5 power) of ankle dorsiflexion (ADF) on Medical Research Council manual muscle testing on presentation at our center were identified by retrospective review. After initiation of standard treatment, ADF power was serially tabulated, and predictors of recovery were determined.

Results: Of the 27 identified patients, ADF power at presentation was <3/5 in 48/54 legs. At 1 y after treatment, ADF power improved to >/= 3/5 in 17/27 patients in one (N = 6) or both (N = 11) legs. On multi-variate analysis, predictors of recovery of ADF power were tibialis anterior compound muscle action potential amplitude at presentation, shorter disease duration, and female gender.

Discussion: Foot drop improves to anti-gravity power in most treated CIDP patients depending in part on the severity of fibular motor axon loss at onset of treatment.
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http://dx.doi.org/10.1002/mus.27253DOI Listing
April 2021

Expression profile of the matricellular protein periostin in paediatric inflammatory bowel disease.

Sci Rep 2021 Mar 18;11(1):6194. Epub 2021 Mar 18.

Department of Biomedical Sciences, Nazarbayev University School of Medicine, Nur-Sultan, Republic of Kazakhstan.

The precise role of periostin, an extra-cellular matrix protein, in inflammatory bowel disease (IBD) is unclear. Here, we investigated periostin in paediatric IBD including its relationship with disease activity, clinical outcomes, genomic variation and expression in the colonic tissue. Plasma periostin was analysed using ELISA in 144 paediatric patients and 38 controls. Plasma levels were assessed against validated disease activity indices in IBD and clinical outcomes. An immuno-fluorescence for periostin and detailed isoform-expression analysis in the colonic tissue was performed in 23 individuals. We integrated a whole-gene based burden metric 'GenePy' to assess the impact of variation in POSTN and 23 other genes functionally connected to periostin. We found that plasma periostin levels were significantly increased during remission compared to active Crohn's disease. The immuno-fluorescence analysis demonstrated enhanced peri-cryptal ring patterns in patients compared to controls, present throughout inflamed, as well as macroscopically non-inflamed colonic tissue. Interestingly, the pattern of isoforms remained unchanged during bowel inflammation compared to healthy controls. In addition to its role during the inflammatory processes in IBD, periostin may have an additional prominent role in mucosal repair. Additional studies will be necessary to understand its role in the pathogenesis, repair and fibrosis in IBD.
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http://dx.doi.org/10.1038/s41598-021-85096-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7973505PMC
March 2021

Conservative treatment for uncomplicated appendicitis in children: the CONTRACT feasibility study, including feasibility RCT.

Health Technol Assess 2021 Feb;25(10):1-192

Department of Health Services Research, Institute of Population Health Sciences, University of Liverpool, Liverpool, UK.

Background: Although non-operative treatment is known to be effective for the treatment of uncomplicated acute appendicitis in children, randomised trial data comparing important outcomes of non-operative treatment with those of appendicectomy are lacking.

Objectives: The objectives were to ascertain the feasibility of conducting a multicentre randomised controlled trial comparing the clinical effectiveness and cost-effectiveness of a non-operative treatment pathway with appendicectomy for the treatment of uncomplicated acute appendicitis in children.

Design: This was a mixed-methods study, which included a feasibility randomised controlled trial, embedded and parallel qualitative and survey studies, a parallel health economic feasibility study and the development of a core outcome set.

Setting: This study was set in three specialist NHS paediatric surgical units in England.

Participants: Children (aged 4-15 years) clinically diagnosed with uncomplicated acute appendicitis participated in the feasibility randomised controlled trial. Children, their families, recruiting clinicians and other health-care professionals involved in caring for children with appendicitis took part in the qualitative study. UK specialist paediatric surgeons took part in the survey. Specialist paediatric surgeons, adult general surgeons who treat children, and children and young people who previously had appendicitis, along with their families, took part in the development of the core outcome set.

Interventions: Participants in the feasibility randomised controlled trial were randomised to a non-operative treatment pathway (broad-spectrum antibiotics and active observation) or appendicectomy.

Main Outcome Measures: The primary outcome measure was the proportion of eligible patients recruited to the feasibility trial.

Data Sources: Data were sourced from NHS case notes, questionnaire responses, transcribed audio-recordings of recruitment discussions and qualitative interviews.

Results: Overall, 50% (95% confidence interval 40% to 59%) of 115 eligible patients approached about the trial agreed to participate and were randomised. There was high acceptance of randomisation and good adherence to trial procedures and follow-up (follow-up rates of 89%, 85% and 85% at 6 weeks, 3 months and 6 months, respectively). More participants had perforated appendicitis than had been anticipated. Qualitative work enabled us to communicate about the trial effectively with patients and families, to design and deliver bespoke training to optimise recruitment and to understand how to optimise the design and delivery of a future trial. The health economic study indicated that the main cost drivers are the ward stay cost and the cost of the operation; it has also informed quality-of-life assessment methods for future work. A core outcome set for the treatment of uncomplicated acute appendicitis in children and young people was developed, containing 14 outcomes. There is adequate surgeon interest to justify proceeding to an effectiveness trial, with 51% of those surveyed expressing a willingness to recruit with an unchanged trial protocol.

Limitations: Because the feasibility randomised controlled trial was performed in only three centres, successful recruitment across a larger number of sites cannot be guaranteed. However, the qualitative work has informed a bespoke training package to facilitate this. Although survey results suggest adequate clinician interest to make a larger trial possible, actual participation may differ, and equipoise may have changed over time.

Conclusions: A future effectiveness trial is feasible, following limited additional preparation, to establish appropriate outcome measures and case identification. It is recommended to include a limited package of qualitative work to optimise recruitment, in particular at new centres.

Future Work: Prior to proceeding to an effectiveness trial, there is a need to develop a robust method for distinguishing children with uncomplicated acute appendicitis from those with more advanced appendicitis, and to reach agreement on a primary outcome measure and effect size that is acceptable to all stakeholder groups involved.

Trial Registration: Current Controlled Trials ISRCTN15830435.

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. 25, No. 10. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta25100DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7958256PMC
February 2021

CONservative TReatment of Appendicitis in Children: a randomised controlled feasibility Trial (CONTRACT).

Arch Dis Child 2021 Jan 13. Epub 2021 Jan 13.

Centre for Surgical Research and NIHR Bristol Biomedical Research Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.

Objective: To establish the feasibility of a multicentre randomised controlled trial to assess the effectiveness and cost-effectiveness of a non-operative treatment pathway compared with appendicectomy in children with uncomplicated acute appendicitis.

Design: Feasibility randomised controlled trial with embedded qualitative study to inform recruiter training to optimise recruitment and the design of a future definitive trial.

Setting: Three specialist paediatric surgery centres in the UK.

Patients: Children (aged 4-15 years) with a clinical diagnosis of uncomplicated acute appendicitis.

Interventions: Appendicectomy or a non-operative treatment pathway (comprising broad-spectrum antibiotics and active observation).

Main Outcome Measures: Primary outcome measure was the proportion of eligible patients recruited. Secondary outcomes evaluated adherence to interventions, data collection during follow-up, safety of treatment pathways and clinical course.

Results: Fifty per cent of eligible participants (95% CI 40 to 59) approached about the trial agreed to participate and were randomised. Repeated bespoke recruiter training was associated with an increase in recruitment rate over the course of the trial from 38% to 72%. There was high acceptance of randomisation, good patient and surgeon adherence to trial procedures and satisfactory completion of follow-up. Although more participants had perforated appendicitis than had been anticipated, treatment pathways were found to be safe and adverse event profiles acceptable.

Conclusion: Recruitment to a randomised controlled trial examining the effectiveness and cost-effectiveness of a non-operative treatment pathway compared with appendicectomy for the treatment of uncomplicated acute appendicitis in children is feasible.

Trial Registration Number: ISRCTN15830435.
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http://dx.doi.org/10.1136/archdischild-2020-320746DOI Listing
January 2021

Ongoing care for the patient with an anorectal malfromation; transitioning to adulthood.

Semin Pediatr Surg 2020 Dec 8;29(6):150991. Epub 2020 Nov 8.

Southampton Children's Hospital, Tremona Road, Southampton, UK.

Planned health care transition can improve the ability of young adults to manage their own health care to effecively use health services and ultimately maximize life-long functioning and well-being. Transitional care is a purposeful, planned process that addresses the medical, psychosocial and educational needs of adolescents and young adults with chronic physical and medical conditions as they move from child-centered to adult-oriented healthcare systems. Unsuccessful surgical transtion may result in physical and mental health implications for young patients, negative long-term outcomes and suboptimal use of health care resources. Anorectal malformation and Hirschsprung patients are an especially vulnerable patient population with ongoing surgical, physiologic and pyschosocial challenges.
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http://dx.doi.org/10.1016/j.sempedsurg.2020.150991DOI Listing
December 2020

Yoga is effective in treating symptoms of Gulf War illness: A randomized clinical trial.

J Psychiatr Res 2020 Nov 11. Epub 2020 Nov 11.

War Related Illness and Injury Study Center, VA Palo Alto Healthcare System, Palo Alto, CA, USA.

Many Veterans of the 1990-1991 Gulf War report symptoms of Gulf War Illness, a condition involving numerous chronic symptoms including pain, fatigue, and mood/cognition symptoms. Little is known about this condition's etiology and treatment. This study reports outcomes from a randomized controlled single-blind trial comparing yoga to cognitive behavioral therapy for chronic pain and other symptoms of Gulf War Illness. Participants were Veterans with symptoms of GWI: chronic pain, fatigue and cognition-mood symptoms. Seventy-five Veterans were randomized to treatment via selection of envelopes from a bag (39 yoga, 36 cognitive behavioral therapy), which consisted of ten weekly group sessions. The primary outcomes of pain severity and interference (Brief Pain Inventory- Short Form) improved in the yoga condition (Cohen's d = .35, p = 0.002 and d = 0.69, p < 0.001, respectively) but not in the CBT condition (d = 0.10, p = 0.59 and d = 0.25 p = 0.23). However, the differences between groups were not statistically significant (d = 0.25, p = 0.25; d = 0.43, p = 0.076), though the difference in an a-priori-defined experimental outcome variable which combines these two variables into a total pain variable (d = 0.47, p = 0.047) was significant. Fatigue, as indicated by a measure of functional exercise capacity (6-min walk test) was reduced significantly more in the yoga group than in the CBT group (between-group d = .27, p = 0.044). Other secondary outcomes of depression, wellbeing, and self-reported autonomic nervous system symptoms did not differ between groups. No adverse events due to treatment were reported. Yoga may be an effective treatment for core Gulf War Illness symptoms of pain and fatigue, making it one of few treatments with empirical support for GWI. Results support further evaluation of yoga for treating veterans with Gulf War Illness. CLINICAL TRIAL REGISTRY: clinicaltrials.gov Registration Number NCT02378025.
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http://dx.doi.org/10.1016/j.jpsychires.2020.11.024DOI Listing
November 2020

Innovative COVID-19 Programs to Rapidly Serve New Mexico : Project ECHO.

Public Health Rep 2021 Jan/Feb;136(1):39-46. Epub 2020 Nov 20.

1104 University of New Mexico's Health Sciences Center and the ECHO Institute, Albuquerque, NM, USA.

Project ECHO (Extension for Community Healthcare Outcomes) at the University of New Mexico is a telementoring program that uses videoconferencing technology to connect health care providers in underserved communities with subject matter experts. In March 2020, Project ECHO created 10 coronavirus disease 2019 (COVID-19) telementoring programs to meet the public health needs of clinicians and teachers living in underserved rural and urban regions of New Mexico. The newly created COVID-19 programs include 7 weekly sessions (Community Health Worker [in English and Spanish], Critical Care, Education, First-Responder Resiliency, Infectious Disease Office Hours, and Multi-specialty) and 3 one-day special sessions. We calculated the total number of attendees, along with the range and standard deviation, per session by program. Certain programs (Critical Care, Infectious Disease Office Hours, Multi-specialty) recorded the profession of attendees when available. The Project ECHO research team collected COVID-19 infection data by county from March 11 through May 31, 2020. During that same period, 9765 health care and general education professionals participated in the COVID-19 programs, and participants from 31 of 35 (89%) counties in New Mexico attended the sessions. Our initial evaluation of these programs demonstrates that an interprofessional clinician group and teachers used the Project ECHO network to build a community of practice and social network while meeting their educational and professional needs. Because of Project ECHO's large reach, the results of the New Mexico COVID-19 response suggest that the rapid use of ECHO telementoring could be used for other urgent national public health problems.
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http://dx.doi.org/10.1177/0033354920969180DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7856386PMC
December 2020

Amiodarone-induced neuromyopathy in a geriatric patient.

BMJ Case Rep 2020 Nov 4;13(11). Epub 2020 Nov 4.

Division of Geriatrics, Department of Medicine, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.

Amiodarone is an antiarrhythmic medication with many side effects. Neuromyopathy is a rare adverse effect. We present an 87-year-old woman with bilateral leg pain and weakness in the context of amiodarone. She was admitted to the Acute Geriatric Unit in Calgary, Alberta, Canada. On examination, hip flexor and extensor strength were 2/5 bilaterally while knee flexor and extensor strength were 4/5 and 3/5, respectively. Creatine kinase and C-reactive protein levels were normal. MRI of the lumbar spine showed mild central canal stenosis. Electromyography and nerve conduction testing showed a severe axonal length-dependent polyneuropathy of the left lower extremity. There was evidence of myopathic changes to the left iliopsoas muscle. Overall, a neuromyopathic process affecting the lower extremities was supported. After discontinuation of amiodarone, mobility and function significantly improved. Although a rare complication of amiodarone, neuromyopathy should be considered in patients with compatible symptomatology.
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http://dx.doi.org/10.1136/bcr-2020-236620DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7643464PMC
November 2020

Adaptations to the current ECCO/ESPGHAN guidelines on the management of paediatric acute severe colitis in the context of the COVID-19 pandemic: a RAND appropriateness panel.

Gut 2020 Sep 1. Epub 2020 Sep 1.

Department of Paediatric Gastroenterology, Evelina London Children's Hospital, London, UK

Objective: Paediatric acute severe colitis (ASC) management during the novel SARS-CoV-2/COVID-19 pandemic is challenging due to reliance on immunosuppression and the potential for surgery. We aimed to provide COVID-19-specific guidance using the European Crohn's and Colitis Organisation/European Society for Paediatric Gastroenterology, Hepatology and Nutrition guidelines for comparison.

Design: We convened a RAND appropriateness panel comprising 14 paediatric gastroenterologists and paediatric experts in surgery, rheumatology, respiratory and infectious diseases. Panellists rated the appropriateness of interventions for ASC in the context of the COVID-19 pandemic. Results were discussed at a moderated meeting prior to a second survey.

Results: Panellists recommended patients with ASC have a SARS-CoV-2 swab and expedited biological screening on admission and should be isolated. A positive swab should trigger discussion with a COVID-19 specialist. Sigmoidoscopy was recommended prior to escalation to second-line therapy or colectomy. Methylprednisolone was considered appropriate first-line management in all, including those with symptomatic COVID-19. Thromboprophylaxis was also recommended in all. In patients requiring second-line therapy, infliximab was considered appropriate irrespective of SARS-CoV-2 status. Delaying colectomy due to SARS-CoV-2 infection was considered inappropriate. Corticosteroid tapering over 8-10 weeks was deemed appropriate for all. After successful corticosteroid rescue, thiopurine maintenance was rated appropriate in patients with negative SARS-CoV-2 swab and asymptomatic patients with positive swab but uncertain in symptomatic COVID-19.

Conclusion: Our COVID-19-specific adaptations to paediatric ASC guidelines using a RAND panel generally support existing recommendations, particularly the use of corticosteroids and escalation to infliximab, irrespective of SARS-CoV-2 status. Consideration of routine prophylactic anticoagulation was recommended.
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http://dx.doi.org/10.1136/gutjnl-2020-322449DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7470179PMC
September 2020

Stigma, Opioids, and Public Health Messaging: The Need to Disentangle Behavior From Identity.

Am J Public Health 2020 06 16;110(6):807-810. Epub 2020 Apr 16.

All authors are with the Department of Health Sciences, California State University East Bay, Hayward.

Stigma plays an important role in understanding successful interventions to control the opioid epidemic in the United States. Stigma has been described both as an agent to incentivize positive health behavior and as an agent of marginalization contributing to poorer health. Past scholarship has argued that stigma has positively motivated public health changes, for example, among tobacco users; it has also been associated with discrimination against vulnerable individuals, resulting in increasingly poorer health behaviors, for example in relation to HIV-prevention messaging.The discourse on stigma may conflate the denormalization of unhealthy behaviors with wholesale rejection of individual identities. More effective interventions would counter stigma against people who use opioids in general and specifically denormalize opioid misuse. These interventions might alter the effect of public health messaging and ultimately improve outcomes.We argue that public health educators and communication campaigns can contribute to positive social norm change and motivate healthy behaviors by incorporating strategies that attempt to disentangle unhealthy behaviors from identity.
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http://dx.doi.org/10.2105/AJPH.2020.305628DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7204447PMC
June 2020

Rapid-Infusion Rituximab in a Pediatric Population.

J Pediatr Pharmacol Ther 2020 ;25(3):215-219

Objectives: The use of rapid rituximab infusion in certain pediatric populations has generally been regarded as safe. The safety of our institution's rapid rituximab protocol was evaluated.

Methods: The primary end point was the number of and severity of adverse drug reactions. Secondary end points included a description of the patient population defined by the indication, dose, and number of rituximab infusions administered. Additionally, the difference in infusion times in hours of those receiving rapid rituximab infusions versus the theoretical infusion time of subsequent administration rate schedules was defined.

Results: A total of 88 infusions for 22 patients were reviewed. No dose-limiting adverse reactions were observed. Three patients experienced grade 1 isolated infusion-related adverse events during a single infusion encounter. Two of the three patients received additional doses of rapid rituximab infusions without incident, whereas the other patient no longer required rituximab therapy.

Conclusions: The use of a 90-minute rituximab infusion protocol in pediatric patients with non-rheumatic diseases was well tolerated.
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http://dx.doi.org/10.5863/1551-6776-25.3.215DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7134582PMC
January 2020

Implementing an early feeding pathway post gastrostomy insertion reduces inpatient stay.

J Pediatr Surg 2020 May 13;55(5):861-865. Epub 2020 Feb 13.

Department of Paediatric Surgery and Urology, Southampton Children's Hospital, Southampton, UK; University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, UK. Electronic address:

Background: There is no consensus regarding optimal postoperative feeding strategy following gastrostomy insertion in children. The aim of this study was to determine whether implementing an early postoperative feeding pathway reduces length of stay (LOS) without increasing complications.

Methods: A retrospective case note review of all children having a new gastrostomy inserted during a one-year period prior to (July 2016-July 2017) and following (July 2017-July 2018) pathway introduction was performed. Children unable to follow the pathway for coexisting medical or nutritional reasons were excluded. The pathway comprised feeding 50% of normal feed 2 hours postprocedure, followed by 100% of normal feed at 5 and 8 h. Previously, patients were fed postoperatively according to surgeon preference.

Results: 116 cases met inclusion criteria, 55 prior to and 61 after pathway implementation. Children following the early feeding pathway had a shorter postoperative LOS than the historical group (median 28 vs 33 h, p < 0.003), while immediate (<72 h) and early (<30 day) complication rates were similar (8.2 vs 7.3%, p = 1.00 and 12 vs 16%, p = 0.59, respectively).

Conclusions: Early postoperative feeding after gastrostomy insertion is safe and reduces LOS.

Type Of Study: Quality improvement.

Level Of Evidence: III.
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http://dx.doi.org/10.1016/j.jpedsurg.2020.01.024DOI Listing
May 2020

Surgery and paediatric inflammatory bowel disease.

Transl Pediatr 2019 Dec;8(5):436-448

Department of Paediatric Surgery, University Hospital Southampton, Southampton, UK.

The incidence of paediatric Crohn's disease (CD) and ulcerative colitis (UC) is increasing. Surgical intervention is required during childhood in approximately 25% of children diagnosed with CD, and for 10% of those diagnosed with UC. Although there is evidence that the rate of surgical intervention undertaken in children is decreasing since the introduction of biologic therapy, this may only represent a delay rather than true reversal of the risk of surgery. Surgery for CD is not curative and limited resection is the key principle thus preserving bowel length. For UC, subtotal colectomy is relatively curative; ileo-anal pouch anastomosis can be performed to restore bowel continuity.
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http://dx.doi.org/10.21037/tp.2019.09.01DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6970124PMC
December 2019

Should we give up on motivational interviewing? Not so fast.

Heart 2020 03 7;106(6):409-410. Epub 2020 Jan 7.

Department of Health Sciences, California State University East Bay, Hayward, California, USA.

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http://dx.doi.org/10.1136/heartjnl-2019-316170DOI Listing
March 2020

Fruits and Vegetables Versus Vegetables and Fruits: Rhyme and Reason for Word Order in Health Messages.

Am J Lifestyle Med 2019 May-Jun;13(3):224-234. Epub 2018 May 2.

Stanford Prevention Research Center, Stanford University School of Medicine, Palo Alto, California (LCO, MEH, CDG).

Both vegetable and fruit consumption contribute to wellness and disease prevention. Most dietary health messages promote both together and position the word "fruits" before "vegetables." We examined the word order of the commonly used phrase "fruits and vegetables" through linguistics, psychology, botany, nutrition, health outcomes, and current US intake to determine if the common word order best presents these two foods in health messaging. By comparing the 10 most commonly consumed vegetables versus fruits, we found that vegetables scored higher on the Aggregate Nutrient Density Index and contained fewer calories and more fiber than fruits. Among the "nutrients of public concern" listed in the 2015 Dietary Guidelines for Americans, we determined that vegetables are better sources of these nutrients than fruits, although fruits scored higher in antioxidant content. In observational cohort studies, vegetable and fruit consumption was found to be associated with decreased mortality. Finally, daily intakes of both vegetables and fruits are lower than recommended, but the discrepancy is larger for vegetables-especially among children-suggesting a greater imperative to promote vegetables. For these reasons, future health messages promoting both together should intentionally put "vegetables" first to promote intake and emphasize their importance regarding contribution to health.
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http://dx.doi.org/10.1177/1559827618769605DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6506980PMC
May 2018

To Text or Not to Text: Electronic Message Intervention to Improve Treatment Adherence Versus Matched Historical Controls.

JMIR Mhealth Uhealth 2019 04 9;7(4):e11720. Epub 2019 Apr 9.

Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, United States.

Background: Ensuring treatment adherence is important for the internal validity of clinical trials. In intervention studies where touch points decrease over time, there is even more of an adherence challenge. Trials with multiple cohorts offer an opportunity to innovate on ways to increase treatment adherence without compromising the integrity of the study design, and previous cohorts can serve as historical controls. Electronically delivered nudges offer low-cost opportunities to increase treatment adherence.

Objective: This study aimed to evaluate the effectiveness of electronic messages (e-messages) on treatment adherence to the last cohort of a parent weight loss intervention during the second half of a year-long trial, when intervention checkpoint frequency decreases. Treatment adherence is measured by intervention class attendance and adherence to the intervention diet.

Methods: All participants in the last cohort (cohort 5, n=128) of a large randomized weight loss study were offered an e-message intervention to improve participant adherence during the last 6 months of a 1-year weight loss program. Overall, 3 to 4 electronic weekly messages asked participants about intervention diet adherence. A propensity score model was estimated using 97 participants who opted to receive e-messages and 31 who declined in cohort 5 and used to pair match cohort 5 e-message participants to a historical control group from cohorts 1 to 4. Moreover, 88 participants had complete data, yielding 176 participants in the final analyses. After matching, intervention and matched control groups were compared on (1) proportion of class attendance between the 6 and 12 month study endpoints, (2) diet adherence, as measured by total carbohydrate grams for low-carbohydrate (LC) and total fat grams for low-fat (LF) diets at 12 months, and (3) weight change from 6 to 12 months. The dose-response relationship between the proportion of text messages responded to and the 3 outcomes was also investigated.

Results: Compared with matched controls, receiving e-messages had no effect on (1) treatment adherence; class attendance after 6 months +4.6% (95% CI -4.43 to 13.68, P=.31), (2) adherence; LC -2.5 g carbohydrate, 95% CI -29.9 to 24.8, P=.85; LF +6.2 g fat, 95% CI -4.1 to 17.0, P=.26); or on (3) the secondary outcome of weight change in the last 6 months; +0.3 kg (95% CI -1.0 to 1.5, P=.68). There was a positive significant response correlation between the percentage of messages to which participants responded and class attendance (r=.45, P<.001).

Conclusions: Although this e-message intervention did not improve treatment adherence, future studies can learn from this pilot and may incorporate more variety in the prompts and more interaction to promote more effective user engagement. Uniquely, this study demonstrated the potential for innovating within a multicohort trial using propensity score-matched historical control subjects.

Trial Registration: ClinicalTrials.gov NCT01826591; https://clinicaltrials.gov/ct2/show/NCT01826591.

International Registered Report Identifier (irrid): RR2-10.1016/j.cct.2016.12.021.
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http://dx.doi.org/10.2196/11720DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6534047PMC
April 2019

Increased prevalence of anti-TNF therapy in paediatric inflammatory bowel disease is associated with a decline in surgical resections during childhood.

Aliment Pharmacol Ther 2019 02 9;49(4):398-407. Epub 2019 Jan 9.

Department of Paediatric Gastroenterology, Southampton Children's Hospital, Southampton, UK.

Background: Anti-tumour necrosis factor-α (anti-TNF) therapy use has risen in paediatric-onset inflammatory bowel disease (PIBD). Whether this has translated into preventing/delaying childhood surgery is uncertain. The Wessex PIBD cohort was analysed for trends in anti-TNF-therapy and surgery.

Aim: To assess patients diagnosed with PIBD within Wessex from 1997 to 2017. The prevalence of anti-TNF-therapy and yearly surgery rates (resection and perianal) during childhood (<18 years) were analysed (Pearson's correlation, multivariate regression, Fisher's exact).

Results: Eight-hundred-and-twenty-five children were included (498 Crohn's disease, 272 ulcerative colitis, 55 IBD-unclassified), mean age at diagnosis 13.6 years (1.6-17.6), 39.6% female. The prevalence of anti-TNF-treated patients increased from 5.1% to 27.1% (2007-2017), P = 0.0001. Surgical resection-rate fell (7.1%-1.5%, P = 0.001), driven by a decrease in Crohn's disease resections (8.9%-2.3%, P = 0.001). Perianal surgery and ulcerative colitis resection-rates were unchanged. Time from diagnosis to resection increased (1.6-2.8 years, P = 0.028) but mean age at resection was unchanged. Patients undergoing resections during childhood were diagnosed at a younger age in the most recent 5 years (2007-2011 = 13.1 years, 2013-2017 = 11.9 years, P = 0.014). Resection-rate in anti-TNF-therapy treated (16.1%) or untreated (12.2%) was no different (P = 0.25). Patients started on anti-TNF-therapy <3 years post-diagnosis (11.6%) vs later (28.6%) had a reduction in resections, P = 0.047. Anti-TNF-therapy prevalence was the only significant predictor of resection-rate using multivariate regression (P = 0.011).

Conclusions: The prevalence of anti-TNF-therapy increased significantly, alongside a decrease in surgical resection-rate. Patients diagnosed at younger ages still underwent surgery during childhood. Anti-TNF-therapy may reduce the need for surgical intervention in childhood, thereby influencing the natural history of PIBD.
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http://dx.doi.org/10.1111/apt.15094DOI Listing
February 2019

The Excised Appendix Tip-To Send or not to Send, That is the Question.

European J Pediatr Surg Rep 2018 Jan 18;6(1):e81-e82. Epub 2018 Oct 18.

Department of Paediatric Surgery and Urology, Southampton Children's Hospital, Southampton, United Kingdom of Great Britain and Northern Ireland.

A 9-year-old boy, with previous anorectal malformation and neuropathic bladder and bowel, underwent ileocystoplasty, Monti-Mitrofanoff and appendix antegrade colonic enema procedure. The tip of the macroscopically normal appendix was sent for routine histopathology. Microscopy demonstrated a 5-mm well-differentiated neuroendocrine tumor extending into muscularis propria. K -67 index was <2%. Due to margin involvement, the appendix conduit and surrounding skin were re-excised and a tube cecostomy was created through a separate incision. Microscopy revealed no residual neuroendocrine tumor, and no further treatment was required.
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http://dx.doi.org/10.1055/s-0038-1672166DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6193799PMC
January 2018

Management of Paediatric Ulcerative Colitis, Part 2: Acute Severe Colitis-An Evidence-based Consensus Guideline From the European Crohn's and Colitis Organization and the European Society of Paediatric Gastroenterology, Hepatology and Nutrition.

J Pediatr Gastroenterol Nutr 2018 08;67(2):292-310

The Royal Hospital for Children, Glasgow, UK.

Background And Aim: Acute severe colitis (ASC) is one of the few emergencies in pediatric gastroenterology. Tight monitoring and timely medical and surgical interventions may improve outcomes and minimize morbidity and mortality. We aimed to standardize daily treatment of ASC in children through detailed recommendations and practice points which are based on a systematic review of the literature and consensus of experts.

Methods: These guidelines are a joint effort of the European Crohn's and Colitis Organization (ECCO) and the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN). Fifteen predefined questions were addressed by working subgroups. An iterative consensus process, including 2 face-to-face meetings, was followed by voting of the national representatives of ECCO and all members of the Paediatric Inflammatory Bowel Disease (IBD) Porto group of ESPGHAN (43 voting experts).

Results: A total of 24 recommendations and 43 practice points were endorsed with a consensus rate of at least 91% regarding diagnosis, monitoring, and management of ASC in children. A summary flowchart is presented based on daily scoring of the Paediatric Ulcerative Colitis Activity Index. Several topics have been altered since the previous 2011 guidelines and from those published in adults.

Discussion: These guidelines standardize the management of ASC in children in an attempt to optimize outcomes of this intensive clinical scenario.
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http://dx.doi.org/10.1097/MPG.0000000000002036DOI Listing
August 2018

Management of Paediatric Ulcerative Colitis, Part 1: Ambulatory Care-An Evidence-based Guideline From European Crohn's and Colitis Organization and European Society of Paediatric Gastroenterology, Hepatology and Nutrition.

J Pediatr Gastroenterol Nutr 2018 08;67(2):257-291

The Royal Hospital for Children, Glasgow, UK.

Background: The contemporary management of ambulatory ulcerative colitis (UC) continues to be challenging with ∼20% of children needing a colectomy within childhood years. We thus aimed to standardize daily treatment of pediatric UC and inflammatory bowel diseases (IBD)-unclassified through detailed recommendations and practice points.

Methods: These guidelines are a joint effort of the European Crohn's and Colitis Organization (ECCO) and the Paediatric IBD Porto group of European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN). An extensive literature search with subsequent evidence appraisal using robust methodology was performed before 2 face-to-face meetings. All 40 included recommendations and 86 practice points were endorsed by 43 experts in Paediatric IBD with at least an 88% consensus rate.

Results: These guidelines discuss how to optimize the use of mesalamine (including topical), systemic and locally active steroids, thiopurines and, for more severe disease, biologics. The use of other emerging therapies and the role of surgery are also covered. Algorithms are provided to aid therapeutic decision-making based on clinical assessment and the Paediatric UC Activity Index (PUCAI). Advice on contemporary therapeutic targets incorporating the use of calprotectin and the role of therapeutic drug monitoring are presented, as well as other management considerations around pouchitis, extraintestinal manifestations, nutrition, growth, psychology, and transition. A brief section on disease classification using the PIBD-classes criteria and IBD-unclassified is also part of these guidelines.

Conclusions: These guidelines provide a guide to clinicians managing children with UC and IBD-unclassified management to provide modern management strategies while maintaining vigilance around appropriate outcomes and safety issues.
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http://dx.doi.org/10.1097/MPG.0000000000002035DOI Listing
August 2018

CONTRACT Study - CONservative TReatment of Appendicitis in Children (feasibility): study protocol for a randomised controlled Trial.

Trials 2018 Mar 2;19(1):153. Epub 2018 Mar 2.

Department of Paediatric Surgery and Urology, Southampton Children's Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK.

Background: Currently, the routine treatment for acute appendicitis in the United Kingdom is an appendicectomy. However, there is increasing scientific interest and research into non-operative treatment of appendicitis in adults and children. While a number of studies have investigated non-operative treatment of appendicitis in adults, this research cannot be applied to the paediatric population. Ultimately, we aim to perform a UK-based multicentre randomised controlled trial (RCT) to test the clinical and cost effectiveness of non-operative treatment of acute uncomplicated appendicitis in children, as compared with appendicectomy. First, we will undertake a feasibility study to assess the feasibility of performing such a trial.

Methods/design: The study involves a feasibility RCT with a nested qualitative research to optimise recruitment as well as a health economic substudy. Children (aged 4-15 years inclusive) diagnosed with acute uncomplicated appendicitis that would normally be treated with an appendicectomy are eligible for the RCT. Exclusion criteria include clinical/radiological suspicion of perforated appendicitis, appendix mass or previous non-operative treatment of appendicitis. Participants will be randomised into one of two arms. Participants in the intervention arm are treated with antibiotics and regular clinical assessment to ensure clinical improvement. Participants in the control arm will receive appendicectomy. Randomisation will be minimised by age, sex, duration of symptoms and centre. Children and families who are approached for the RCT will be invited to participate in the embedded qualitative substudy, which includes recording of recruitment consultants and subsequent interviews with participants and non-participants and their families and recruiters. Analyses of these will inform interventions to optimise recruitment. The main study outcomes include recruitment rate (primary outcome), identification of strategies to optimise recruitment, performance of trial treatment pathways, clinical outcomes and safety of non-operative treatment. We have involved children, young people and parents in study design and delivery.

Discussion: In this study we will explore the feasibility of performing a full efficacy RCT comparing non-operative treatment with appendicectomy in children with acute uncomplicated appendicitis. Factors determining success of the present study include recruitment rate, safety of non-operative treatment and adequate interest in the future RCT. Ultimately this feasibility study will form the foundation of the main RCT and reinforce its design.

Trial Registration: ISRCTN15830435 . Registered on 8 February 2017.
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http://dx.doi.org/10.1186/s13063-018-2520-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5833142PMC
March 2018

Performing a digital rectal examination: indications and examination.

Br J Hosp Med (Lond) 2018 Feb;79(2):C18-C21

Consultant Paediatric Surgeon, Department of Paediatric Surgery, Southampton General Hospital, Southampton.

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http://dx.doi.org/10.12968/hmed.2018.79.2.C18DOI Listing
February 2018

Performing a digital rectal examination: considerations and interpretation.

Br J Hosp Med (Lond) 2018 Feb;79(2):C22-C26

Consultant Paediatric Surgeon, Department of Paediatric Surgery, Southampton General Hospital, Southampton.

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http://dx.doi.org/10.12968/hmed.2018.79.2.C22DOI Listing
February 2018

Formation of Long-Lived Color Centers for Broadband Visible Light Emission in Low-Dimensional Layered Perovskites.

J Am Chem Soc 2017 12 15;139(51):18632-18639. Epub 2017 Dec 15.

Cavendish Laboratory, University of Cambridge , CB3 0HE Cambridge, United Kingdom.

We investigate the origin of the broadband visible emission in layered hybrid lead-halide perovskites and its connection with structural and photophysical properties. We study ⟨001⟩ oriented thin films of hexylammonium (HA) lead iodide, (CHN)PbI, and dodecylammonium (DA) lead iodide, (CHN)PbI, by combining first-principles simulations with time-resolved photoluminescence, steady-state absorption and X-ray diffraction measurements on cooling from 300 to 4 K. Ultrafast transient absorption and photoluminescence measurements are used to track the formation and recombination of emissive states. In addition to the excitonic photoluminescence near the absorption edge, we find a red-shifted, broadband (full-width at half-maximum of about 0.4 eV), emission band below 200 K, similar to emission from ⟨110⟩ oriented bromide 2D perovskites at room temperature. The lifetime of this sub-band-gap emission exceeds that of the excitonic transition by orders of magnitude. We use X-ray diffraction measurements to study the changes in crystal lattice with temperature. We report changes in the octahedral tilt and lattice spacing in both materials, together with a phase change around 200 K in DAPbI. DFT simulations of the HAPbI crystal structure indicate that the low-energy emission is due to interstitial iodide and related Frenkel defects. Our results demonstrate that white-light emission is not limited to ⟨110⟩ oriented bromide 2D perovskites but a general property of this class of system, and highlight the importance of defect control for the formation of low-energy emissive sites, which can provide a pathway to design tailored white-light emitters.
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http://dx.doi.org/10.1021/jacs.7b10223DOI Listing
December 2017

Long-term outcomes of congenital lung malformations.

Semin Pediatr Surg 2017 Oct 9;26(5):311-316. Epub 2017 Sep 9.

Department of Paediatric Surgery and Urology, Southampton Children's Hospital, Southampton, UK.

Congenital lung malformations comprise a group of anatomical abnormalities of the respiratory tree including congenital cystic malformations, bronchopulmonary sequestrations, bronchogenic cyst, bronchial atresia, and congenital lobar emphysema. These anomalies are detected with increasing frequency by pre-natal sonography, but may also present for the first time with symptoms in childhood or later life. When symptomatic, there is little controversy that resection is indicated, which is usually curative. When a lesion is asymptomatic there is greater debate regarding the benefit of resection versus continued observation. This article provides an overview of the spectrum of disorders, the management options available and the long-term outcomes associated with each treatment option.
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http://dx.doi.org/10.1053/j.sempedsurg.2017.09.001DOI Listing
October 2017

Development of a Click Beetle Luciferase Reporter System for Enhanced Bioluminescence Imaging of : Analysis in Cell Culture and Murine Infection Models.

Front Microbiol 2017 26;8:1797. Epub 2017 Sep 26.

APC Microbiome Institute, University College Cork, Cork, Ireland.

is a Gram-positive facultative intracellular pathogen that is widely used as a model organism for the analysis of infection biology. In this context, there is a current need to develop improved reporters for enhanced bioluminescence imaging (BLI) of the pathogen in infection models. We have developed a click beetle red luciferase (CBR-) based vector (pPL2CBR) expressing codon optimized CBR- under the control of a highly expressed Listerial promoter (P) for and have compared this to a -based system expressing bacterial luciferase for BLI of the pathogen using growth experiments and models. The CBR- plasmid stably integrates into the chromosome and can be used to label field isolates and laboratory strains of the pathogen. Growth experiments revealed that CBR- labeled emits a bright signal in exponential phase that is maintained during stationary phase. In contrast, -labeled bacteria produced a light signal that peaked during exponential phase and was significantly reduced during stationary phase. Light from CBR- labeled bacteria was more efficient than the signal from -labeled bacteria in penetrating an artificial tissue depth assay system. A cell invasion assay using C2Bbe1 cells and a systemic murine infection model revealed that CBR- is suited to BLI approaches and demonstrated enhanced sensitivity relative to in the context of infection models. Overall, we demonstrate that this novel CBR reporter system provides efficient, red-shifted light production relative to and may have significant applications in the analysis of pathogenesis.
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http://dx.doi.org/10.3389/fmicb.2017.01797DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5622934PMC
September 2017

A Single-Tunnel Technique for Coracoclavicular and Acromioclavicular Ligament Reconstruction.

Arthrosc Tech 2017 Jun 12;6(3):e769-e775. Epub 2017 Jun 12.

Kerlan Jobe Orthopaedic Clinic, Los Angeles, California, U.S.A.

Acromioclavicular (AC) joint separation is a common injury seen in the young adult athletic population. Both the indications for surgical management and the best operative technique remain controversial. One of the most popular reconstruction techniques is the anatomic double-tunnel coracoclavicular (CC) ligament reconstruction. However, there have been several case reports of clavicle fractures with this technique. This article presents a single-tunnel reconstruction technique that aims to restore both the CC and AC ligament function, while minimizing fracture risk.
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http://dx.doi.org/10.1016/j.eats.2017.02.024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5496012PMC
June 2017

Meta-analysis without study-specific variance information: Heterogeneity case.

Stat Methods Med Res 2019 01 6;28(1):196-210. Epub 2017 Jul 6.

5 Statistics and Quantitative Methods, Faculty of Psychology and Sports Science, University of Münster, Germany.

The random effects model in meta-analysis is a standard statistical tool often used to analyze the effect sizes of the quantity of interest if there is heterogeneity between studies. In the special case considered here, meta-analytic data contain only the sample means in two treatment arms and the sample sizes, but no sample standard deviation. The statistical comparison between two arms for this case is not possible within the existing meta-analytic inference framework. Therefore, the main objective of this paper is to estimate the overall mean difference and associated variances, the between-study variance and the within-study variance, as specified as the important elements in the random effects model. These estimators are obtained using maximum likelihood estimation. The standard errors of the estimators and a quantification of the degree of heterogeneity are also investigated. A measure of heterogeneity is suggested which adjusts the original suggested measure of Higgins' I for within study sample size. The performance of the proposed estimators is evaluated using simulations. It can be concluded that all estimated means converged to their associated true parameter values, and its standard errors tended to be small if the number of the studies involved in the meta-analysis was large. The proposed estimators could be favorably applied in a meta-analysis on comparing two surgeries for asymptomatic congenital lung malformations in young children.
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http://dx.doi.org/10.1177/0962280217718867DOI Listing
January 2019

Active observation versus interval appendicectomy after successful non-operative treatment of an appendix mass in children (CHINA study): an open-label, randomised controlled trial.

Lancet Gastroenterol Hepatol 2017 04 7;2(4):253-260. Epub 2017 Feb 7.

Department of Paediatric Surgery and Urology, Southampton Children's Hospital, Southampton, UK.

Background: Despite a scarcity of supporting evidence, most surgeons recommend routine interval appendicectomy after successful non-operative treatment of an appendix mass in children. We aimed to compare routine interval appendicectomy with active observation.

Methods: We enrolled participants in the CHildren's INterval Appendicectomy (CHINA) study, a multicentre, open-label, randomised controlled study at 19 specialist paediatric surgery centres, 17 of which were in the UK, one in Sweden, and one in New Zealand. 106 children aged 3-15 years were assigned (1:1) by weighted minimisation to interval appendicectomy or active observation with minimisation for age, trial centre, sex, and presence of a faecolith on imaging. Eligible children had acute appendicitis with an appendix mass and were successfully treated without appendicectomy or other surgical intervention. Children were excluded from the study if they had coexisting gastrointestinal disease or had a substantial coexisting medical condition or immune defect. Because of the nature of the interventions, blinding was not possible. The primary outcome was the proportion of children developing histologically proven recurrent acute appendicitis or a clinical diagnosis of recurrent appendix mass within 1 year of enrolment after successful non-operative treatment of appendix mass (active observation group) and incidence of severe complications related to interval appendicectomy. Data were analysed on an intention-to-treat basis. This study is registered with ISRCTN, number 93815412.

Findings: Between Aug 8, 2011, and Dec 31, 2014, we randomly assigned 106 patients, 52 patients to interval appendicectomy and 54 to active observation. Two children in the interval appendicectomy group were withdrawn due to withdrawal of consent; two in the active observation group were withdrawn because they became ineligible after allocation. Six children under active observation had histologically proven recurrent acute appendicitis. Three children in the interval appendicectomy group had severe complications. Thus, the proportion of children with histologically proven recurrent acute appendicitis under active observation was 12% (95% CI 5-23) and the proportion of children with severe complications related to interval appendicectomy was 6% (95% CI 1-17).

Interpretation: More than three-quarters of children could avoid appendicectomy during early follow-up after successful non-operative treatment of an appendix mass. Although the risk of complications after interval appendicectomy is low, complications can be severe. Adoption of a wait-and-see approach, reserving appendicectomy for those who develop recurrence or recurrent symptoms, results in fewer days in hospital, fewer days away from normal daily activity, and is cheaper than routine interval appendicectomy. These high-quality data will allow clinicians, parents, and children to make an evidence-based decision regarding the justification for interval appendicectomy.

Funding: BUPA Foundation.
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http://dx.doi.org/10.1016/S2468-1253(16)30243-6DOI Listing
April 2017

Results from a clinical yoga program for veterans: yoga via telehealth provides comparable satisfaction and health improvements to in-person yoga.

BMC Complement Altern Med 2017 Apr 4;17(1):198. Epub 2017 Apr 4.

War Related Illness and Injury Study Center, VA Palo Alto Healthcare System, 3801 Miranda Avenue, Palo Alto, CA, 94301, USA.

Background: Yoga is increasingly popular, though little data regarding its implementation in healthcare settings is available. Similarly, telehealth is being utilized more frequently to increase access to healthcare; however we know of no research on the acceptability or effectiveness of yoga delivered through telehealth. Therefore, we evaluated the feasibility, acceptability, and patient-reported effectiveness of a clinical yoga program at a Veterans Affairs Medical Center and assessed whether these outcomes differed between those participating in-person and those participating via telehealth.

Methods: Veterans who attended a yoga class at the VA Palo Alto Health Care System were invited to complete an anonymous program evaluation survey.

Results: 64 Veterans completed the survey. Participants reported high satisfaction with the classes and the instructors. More than 80% of participants who endorsed a problem with pain, energy level, depression, or anxiety reported improvement in these symptoms. Those who participated via telehealth did not differ from those who participated in-person in any measure of satisfaction, overall improvement (p = .40), or improvement in any of 16 specific health problems.

Conclusions: Delivering yoga to a wide range of patients within a healthcare setting appears to be feasible and acceptable, both when delivered in-person and via telehealth. Patients in this clinical yoga program reported high levels of satisfaction and improvement in multiple problem areas. This preliminary evidence for the effectiveness of a clinical yoga program complements prior evidence for the efficacy of yoga and supports the use of yoga in healthcare settings.
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http://dx.doi.org/10.1186/s12906-017-1705-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5381127PMC
April 2017