Defining and grouping children’s therapeutic footwear and criteria for their prescription: an international expert Delphi consensus study

ObjectivesThis study aimed to achieve an expert consensus on how to define and group footwear interventions for children, with a further focus on the design characteristics and prescription of off-the-shelf stability footwear for children with mobility impairment.SettingA group of multinational professionals, from clinicians to those involved in the footwear industry, were recruited to ensure a spectrum of opinions.ParticipantsThirty panellists were contacted, of which 24 consented to participate and six withdrew before round 1, a further two withdrew after round 1. Sixteen panellists completed the consensus exercise.Primary and secondary outcome measuresA Delphi consensus method was employed with round 1 split into three sections: (1) terms and definitions, (2) specifics of off-the-shelf stability footwear design and (3) criteria for clinical prescription of off-the-shelf stability footwear. The panel was asked to rate their level of agreement with statements and to provide further insights through open-ended questions. The opinions of the experts were analysed to assess consensus set at 75% agreement or to modify or form new statements presented through the subsequent two rounds.ResultsTherapeutic footwear was the agreed term to represent children’s footwear interventions, with grouping and subgrouping of therapeutic footwear being dependent on their intended clinical outcomes (accommodative, corrective or functional). Both the heel counter and topline as well as the stiffness and width of the sole were identified as potentially influencing mediolateral stability in children’s gait. A consensus was achieved in the prescription criteria and outcome measures for off-the-shelf stability therapeutic footwear for cerebral palsy, mobile symptomatic pes planus, Duchenne muscular dystrophy, spina bifida and Down’s syndrome.ConclusionsThrough a structured synthesis of expert opinion, this study has established a standardisation of terminology and groupings along with prescription criteria for the first time. Reported findings have implications for communication between stakeholders, evidence-based clinical intervention and standardised outcome measures to assess effectiveness.

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Applied sport science and medicine of women’s rugby codes: a systematic-scoping review and consensus on future research priorities protocol

BMJ Open Sport & Exercise Medicine ◽

10.1136/bmjsem-2021-001108 ◽

2021 ◽

Vol 7 (3) ◽

pp. e001108

Author(s):

Omar Heyward ◽

Stacey Emmonds ◽

Gregory Roe ◽

Sean Scantlebury ◽

Keith Stokes ◽

...

Keyword(s):

Scoping Review ◽

Research Priorities ◽

Consensus Method ◽

Future Research ◽

Delphi Consensus ◽

Medicine Research ◽

Sport Science ◽

Priority Areas ◽

Wide Range ◽

Scoping Reviews

Women’s rugby (rugby league, rugby union and rugby sevens) has recently grown in participation and professionalisation. There is under-representation of women-only cohorts within applied sport science and medicine research and within the women’s rugby evidence base. The aims of this article are: Part 1: to undertake a systematic-scoping review of the applied sport science and medicine of women’s rugby, and Part 2: to develop a consensus statement on future research priorities. This article will be designed in two parts: Part 1: a systematic-scoping review, and Part 2: a three-round Delphi consensus method. For Part 1, systematic searches of three electronic databases (PubMed (MEDLINE), Scopus, SPORTDiscus (EBSCOhost)) will be performed from the earliest record. These databases will be searched to identify any sport science and medicine themed studies within women’s rugby. The Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for Scoping Reviews will be adhered to. Part 2 involves a three-round Delphi consensus method to identify future research priorities. Identified experts in women’s rugby will be provided with overall findings from Part 1 to inform decision-making. Participants will then be asked to provide a list of research priority areas. Over the three rounds, priority areas achieving consensus (≥70% agreement) will be identified. This study has received institutional ethical approval. When complete, the manuscript will be submitted for publication in a peer-reviewed journal. The findings of this article will have relevance for a wide range of stakeholders in women’s rugby, including policymakers and governing bodies.

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Donepezil for mild cognitive impairment in Parkinson’s disease

Scientific Reports ◽

10.1038/s41598-021-84243-4 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Kyoungwon Baik ◽

Seon Myeong Kim ◽

Jin Ho Jung ◽

Yang Hyun Lee ◽

Seok Jong Chung ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Cognitive Impairment ◽

Mild Cognitive Impairment ◽

Treatment Group ◽

Outcome Measures ◽

Rating Scale ◽

Secondary Outcome ◽

Control Group ◽

Significant Difference

AbstractWe investigated the efficacy of donepezil for mild cognitive impairment in Parkinson’s disease (PD-MCI). This was a prospective, non-randomized, open-label, two-arm study. Eighty PD-MCI patients were assigned to either a treatment or control group. The treatment group received donepezil for 48 weeks. The primary outcome measures were the Korean version of Mini-Mental State Exam and Montreal Cognitive Assessment scores. Secondary outcome measures were the Clinical Dementia Rating, Unified Parkinson’s Disease Rating Scale part III, Clinical Global Impression scores. Progression of dementia was assessed at 48-week. Comprehensive neuropsychological tests and electroencephalography (EEG) were performed at baseline and after 48 weeks. The spectral power ratio of the theta to beta2 band (TB2R) in the electroencephalogram was analyzed. There was no significant difference in the primary and secondary outcome measures between the two groups. However, the treatment group showed a significant decrease in TB2R at bilateral frontotemporoparietal channels compared to the control group. Although we could not demonstrate improvements in the cognitive functions, donepezil treatment had a modulatory effect on the EEG in PD-MCI patients. EEG might be a sensitive biomarker for detecting changes in PD-MCI after donepezil treatment.

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Three-Dimensional Printing in Cleft Care: A Systematic Review

The Cleft Palate-Craniofacial Journal ◽

10.1177/10556656211013175 ◽

2021 ◽

pp. 105566562110131

Author(s):

Farrukh R. Virani ◽

Evan C. Chua ◽

Mary Roz Timbang ◽

Tsung-yen Hsieh ◽

Craig W. Senders

Keyword(s):

Systematic Review ◽

3D Printing ◽

Clinical Outcomes ◽

Outcome Measures ◽

Cleft Lip ◽

Cleft Lip And Palate ◽

Secondary Outcome ◽

Exclusion Criteria ◽

3 Dimensional ◽

Dimensional Printing

Objective: To determine the current applications of 3-dimensional (3D) printing in the care of patients with cleft lip and palate. We also reviewed 3D printing limitations, financial analysis, and future implications. Design: Retrospective systematic review. Methods: Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines were used by 3 independent reviewers. Articles were identified from Cochrane library, Ovid Medline, and Embase. Search terms included 3D printing, 3 dimensional printing, additive manufacturing, rapid prototyping, cleft lip, and cleft palate. Exclusion criteria included articles not in English, animal studies, reviews without original data, oral presentations, abstracts, opinion pieces, and articles without relevance to 3D printing or cleft lip and palate. Main Outcome Measures: Primary outcome measure was the purpose of 3D printing in the care of patients with cleft lip and palate. Secondary outcome measures were cost analysis and clinical outcomes. Results: Eight-four articles were identified, and 39 met inclusion/exclusion criteria. Eleven studies used 3D printing models for nasoalveolar molding. Patient-specific implants were developed via 3D printing in 6 articles. Surgical planning was conducted via 3D printing in 8 studies. Eight articles utilized 3D printing for anatomic models/educational purposes. 3-Dimensional printed models were used for surgical simulation/training in 6 articles. Bioprinting was utilized in 4 studies. Secondary outcome of cost was addressed in 8 articles. Conclusion: 3-Dimensional printing for the care of patients with cleft lip and palate has several applications. Potential advantages of utilizing this technology are demonstrated; however, literature is largely descriptive in nature with few clinical outcome measures. Future direction should be aimed at standardized reporting to include clinical outcomes, cost, material, printing method, and results.

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Effect of ultraprocessed food intake on cardiometabolic risk is mediated by diet quality: a cross-sectional study

BMJ Nutrition, Prevention & Health ◽

10.1136/bmjnph-2020-000225 ◽

2021 ◽

pp. bmjnph-2020-000225

Author(s):

Jennifer Griffin ◽

Anwar Albaloul ◽

Alexandra Kopytek ◽

Paul Elliott ◽

Gary Frost

Keyword(s):

Food Intake ◽

Energy Intake ◽

Food Consumption ◽

Outcome Measures ◽

Diet Quality ◽

Cardiometabolic Risk ◽

Saturated Fat ◽

Secondary Outcome ◽

Cross Sectional ◽

Occupational Cohort

ObjectiveTo examine the effect of the consumption of ultraprocessed food on diet quality, and cardiometabolic risk (CMR) in an occupational cohort.DesignCross-sectional.SettingOccupational cohort.Participants53 163 British police force employees enrolled (2004–2012) into the Airwave Health Monitoring Study. A total of 28 forces across the UK agreed to participate. 9009 participants with available 7-day diet record data and complete co-variate data are reported in this study.Main outcome measuresA CMR and Dietary Approaches to Stop Hypertension score were treated as continuous variables and used to generate measures of cardiometabolic health and diet quality. Secondary outcome measures include percentage of energy from fat, saturated fat, carbohydrate, protein and non-milk extrinsic sugars (NMES) and fibre grams per 1000 kcal of energy intake.ResultsIn this cohort, 58.3%±11.6 of total energy intake was derived from ultraprocessed (NOVA 4) foods. Ultraprocessed food intake was negatively correlated with diet quality (r=−0.32, p<0.001), fibre (r=−0.20, p<0.001) and protein (r = −0.40, p<0.001) and positively correlated with fat (r=0.18, p<0.001), saturated fat (r=0.14, p<0.001) and nmes (r=0.10, p<0.001) intake . Multivariable analysis suggests a positive association between ultraprocessed food (NOVA 4) consumption and CMR. However, this main effect was no longer observed after adjustment for diet quality (p=0.209). Findings from mediation analysis indicate that the effect of ultraprocessed food (NOVA 4) intake on CMR is mediated by diet quality (p<0.001).ConclusionsUltraprocessed food consumption is associated with a deterioration in diet quality and positively associated with CMR, although this association is mediated by and dependent on the quality of the diet. The negative impact of ultraprocessed food consumption on diet quality needs to be addressed and controlled studies are needed to fully comprehend whether the relationship between ultraprocessed food consumption and health is independent to its relationship with poor diet quality.

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Implementation of patient-reported outcome measures and patient-reported experience measures in melanoma clinical quality registries: a systematic review

BMJ Open ◽

10.1136/bmjopen-2020-040751 ◽

2021 ◽

Vol 11 (2) ◽

pp. e040751

Author(s):

Zachary Blood ◽

Anh Tran ◽

Lauren Caleo ◽

Robyn Saw ◽

Mbathio Dieng ◽

...

Keyword(s):

Systematic Review ◽

Cost Effectiveness ◽

Outcome Measures ◽

Cutaneous Melanoma ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Secondary Outcome ◽

Clinical Quality ◽

Patient Reported ◽

Eortc Qlq

ObjectivesTo identify patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) in clinical quality registries, for people with cutaneous melanoma, to inform a new Australian Melanoma Clinical Outcomes Registry; and describe opportunities and challenges of routine PROM/PREM collection, especially in primary care.DesignSystematic review.Primary and secondary outcome measuresWhich PROMs and PREMs are used in clinical quality registries for people with cutaneous melanoma, how they are collected, frequency of collection, participant recruitment methods and funding models for each registry.Results1134 studies were identified from MEDLINE, PreMEDLINE, Embase, PsychInfo, Cochrane Database of Abstracts of Reviews of Effects databases and TUFTS Cost-Effectiveness Analysis Registry, alongside grey literature, from database inception to 5th February 2020. Following screening, 14 studies were included, identifying four relevant registries: Dutch Melanoma Registry, Adelphi Real-World Disease-Specific Programme (Melanoma), Patient-Reported Outcomes Following Initial treatment and Long-term Evaluation of Survivorship Registry, and Cancer Experience Registry. These used seven PROMs: EuroQol-5 Dimensions, Functional Assessment of Cancer-General (FACT-G) and FACT-Melanoma (FACT-M), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cancer 30 (EORTC QLQ-C30), Fatigue Assessment Scale Hospital Anxiety and Depression Scale, Patient-Reported Outcome Measures Information System-29 and one PREM; EORTC QLQ-Information Module 26. PROMs/PREMs in registries were reported to improve transparency of care; facilitate clinical auditing for quality assessment; enable cost-effectiveness analyses and create large-scale research platforms. Challenges included resource burden for data entry and potential collection bias toward younger, more affluent respondents. Feedback from patients with melanoma highlighted the relevance of PROMs/PREMs in assessing patient outcomes and patient experiences.ConclusionsClinical registries indicate PROMs/PREMs for melanoma care can be incorporated and address important gaps, however cost and collection bias may limit generalisability.PROSPERO registration numberCRD42018086737.

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Use of connected digital products in clinical research following the COVID-19 pandemic: a comprehensive analysis of clinical trials

BMJ Open ◽

10.1136/bmjopen-2020-047341 ◽

2021 ◽

Vol 11 (6) ◽

pp. e047341

Author(s):

Caroline Marra ◽

William J Gordon ◽

Ariel Dora Stern

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Outcome Measures ◽

Remote Monitoring ◽

Search Algorithm ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Digital Products ◽

Clinical Trial Registry ◽

Before And After

ObjectivesIn an effort to mitigate COVID-19 related challenges for clinical research, the US Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of connected digital products (CDPs), tools that enable remote patient monitoring and telehealth consultation, in clinical trials both before and after the onset of the pandemic.DesignWe applied a comprehensive text search algorithm to clinical trial registry data to identify trials that use CDPs for remote monitoring or telehealth. We compared CDP use in the months before and after the issuance of FDA guidance facilitating virtual clinical trials.SettingAll trials registered on ClinicalTrials.gov with start dates from May 2019 through February 2021.Outcome measuresThe primary outcome measure was the overall percentage of CDP use in clinical trials started in the 10 months prior to the pandemic onset (May 2019–February 2020) compared with the 10 months following (May 2020–February 2021). Secondary outcome measures included CDP usage by trial type (interventional, observational), funder type (industry, non-industry) and diagnoses (COVID-19 or non-COVID-19 participants).ResultsCDP usage in clinical trials increased by only 1.65 percentage points, from 14.19% (n=23 473) of all trials initiated in the 10 months prior to the pandemic onset to 15.84% (n=26 009) of those started in the 10 months following (p<0.01). The increase occurred primarily in observational studies and non-industry funded trials and was driven entirely by CDP usage in trials for COVID-19.ConclusionsThese findings suggest that in the short-term, new options created by regulatory guidance to stimulate telehealth and remote monitoring were not widely incorporated into clinical research. In the months immediately following the pandemic onset, CDP adoption increased primarily in observational and non-industry funded studies where virtual protocols are likely medically necessary due to the participants’ COVID-19 diagnosis.

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Government management capacities and the containment of COVID-19: a repeated cross-sectional study across Chinese cities

BMJ Open ◽

10.1136/bmjopen-2020-041516 ◽

2021 ◽

Vol 11 (4) ◽

pp. e041516

Author(s):

Wenchao Li ◽

Jing Li ◽

Junjian Yi

Keyword(s):

Outcome Measures ◽

Cross Sectional Study ◽

Control Measures ◽

Secondary Outcome ◽

Cross Sectional ◽

Travel Restrictions ◽

Government Management ◽

The Government ◽

Laws And Policies ◽

Novel Coronavirus

ObjectivesBetter understanding of the dynamics of the COVID-19 (2019 novel coronavirus disease) pandemic to curb its spread is now a global imperative. While travel restrictions and control measures have been shown to limit the spread of the disease, the effectiveness of the enforcement of those measures should depend on the strength of the government. Whether, and how, the government plays a role in fighting the disease, however, has not been investigated. Here, we show that government management capacities are critical to the containment of the disease.SettingWe conducted a statistical analysis based on cross-city comparisons within China. China has undergone almost the entire cycle of the anticoronavirus campaign, which allows us to trace the full dynamics of the outbreak, with homogeneity in standards for statistics recording.Primary and secondary outcome measuresOutcome measures include city-specific COVID-19 case incidence and recoveries in China.ResultsThe containment of COVID-19 depends on the effectiveness of the enforcement of control measures, which in turn depends on the local government’s management capacities. Specifically, government efficiency, capacity for law enforcement, and the transparency of laws and policies significantly reduce COVID-19 prevalence and increase the likelihood of recoveries. The organisation size of the government, which is not closely related to its capacity for management, has a limited role.

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Pulsed Shortwave Therapy in Cervical Osteoarthritis: an NSAID- Controlled, Randomized Clinical Trial

SN Comprehensive Clinical Medicine ◽

10.1007/s42399-020-00652-y ◽

2021 ◽

Author(s):

A. Rachid El Mohammad ◽

Sree Koneru ◽

Richard Staelin ◽

Kenneth McLeod ◽

Omar Tabbouche ◽

...

Keyword(s):

Adverse Effects ◽

Outcome Measures ◽

Neck Disability Index ◽

Primary Outcome Measure ◽

Pain Medication ◽

Secondary Outcome ◽

Pain Duration ◽

Cox 2 ◽

Neck Disability ◽

Pain At Rest

AbstractAssess treatment superiority of pulsed shortwave therapy (PSWT) against COX-2 NSAID therapy, in reducing disability and pain due to cervical osteoarthritis. Two hundred chronic pain suffers (average pain duration about 2 years) diagnosed with cervical osteoarthritis by radiological imaging were randomized into one of two treatment arms: COX-2 NSAID treatment; etoricoxib 60 mg/day for 4 weeks; or PSWT treatment worn 24 h/day for 4 weeks. The primary outcome measure was the 4-week score on the Neck Disability Index (NDI), a 10-question assessment on a 50-point scale. Secondary outcome measures included pain (at rest and during activity) measured on a visual analog scale (VAS) of 0–100 mm, dose count of rescue pain medication (paracetamol) use, and a treatment satisfaction rating. These 4-week scores were compared across the two arms to assess superiority. After 4 weeks of treatment, subjects in both study arms reported statistically significant (p < 0.0001) reductions in NDI, with final scores of 11.24-NSAID and 9.34-PSWT, VASrest, with final scores of 30.08-NSAID; 22.76-PSWT, and VASactivity, with final scores of 36.40-NSAID; 27.42-PSWT. The absolute reduction from baseline in NDI was significantly greater in the PSWT arm than NSAID arm (3.66 points; 95% CI 2.3 to 5.02; p < 0.0001). Similarly, the reductions from baseline in VASrest and VASactivity were significantly greater in the PSWT arm than NSAID arm (10.89 mm; 95% CI 6.90 to 14.87; p < 0.0001; and 12.05 mm; 95% CI 7.76 to 16.33; p < 0.0001, respectively). The PSWT arm used 50% less rescue pain medication. Eleven adverse effects were reported in the NSAID arm and zero in the PSWT arm. Both NSAID and PSWT treatments resulted in statistically significant improvements in quality of life (NDI) and reduction in pain (VAS) resulting from cervical osteoarthritis. However, the PSWT intervention showed superior improvements in all outcome measures when compared to the NSAID arm with no adverse effects. Clinicaltrials.gov (NCT03542955).

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Long-term improvements following a residential combined physical and psychological programme for chronic low back pain

BMJ Open Quality ◽

10.1136/bmjoq-2020-001068 ◽

2021 ◽

Vol 10 (2) ◽

pp. e001068

Author(s):

Shaun Wellburn ◽

Cormac G Ryan ◽

Andrew Coxon ◽

Alastair J Dickson ◽

D John Dickson ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Outcome Measures ◽

Chronic Low Back Pain ◽

Rating Scale ◽

Secondary Outcome ◽

Low Back ◽

Residential Setting ◽

Wide Range

ObjectivesEvaluate the outcomes and explore experiences of patients undergoing a residential combined physical and psychological programme (CPPP) for chronic low back pain.DesignA longitudinal observational cohort design, with a parallel qualitative design using semistructured interviews.SettingResidential, multimodal rehabilitation.Participants136 adults (62 male/74 female) referred to the CPPP, 100 (44 male/56 female) of whom completed the programme, during the term of the study. Ten (2 male/8 female) participated in the qualitative evaluation.InterventionA 3-week residential CPPP.Outcome measuresPrimary outcome measures were the STarT Back screening tool score; pain intensity—11-point Numerical Rating Scale; function—Oswestry Disability Index (ODI); health status/quality of life—EQ-5D-5L EuroQol five-Dimension-five level; anxiety—Generalised Anxiety Disorder-7; depression—Patient Health Questionnaire-9. Secondary outcome measures were the Global Subjective Outcome Scale; National Health Service Friends and Family Test;.ResultsAt discharge, 6 and 12 months follow ups, there were improvements from baseline that were greater than minimum clinically important differences in each of the outcomes (with the sole exception of ODI at discharge). At 12 months, the majority of people considered themselves a lot better (57%) and were extremely likely (86%) to recommend the programme to a friend. The qualitative data showed praise for the residential nature of the intervention and the opportunities for interaction with peers and peer support. There were testimonies of improvements in understanding of pain and how to manage it better. Some participants said they had reduced, or stopped, medication they had been taking to manage their pain.ConclusionsParticipants improved, and maintained long term, beyond minimum clinically important differences on a wide range of outcomes. Participants reported an enhanced ability to self-manage their back pain and support for the residential setting.

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Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-042627 ◽

2021 ◽

Vol 11 (3) ◽

pp. e042627

Author(s):

María Reina-Bueno ◽

María del Carmen Vázquez-Bautista ◽

Inmaculada C Palomo-Toucedo ◽

Gabriel Domínguez-Maldonado ◽

José Manuel Castillo-López ◽

...

Keyword(s):

Quality Of Life ◽

Randomised Controlled Trial ◽

Outcome Measures ◽

Controlled Trial ◽

Secondary Outcome ◽

Foot Orthoses ◽

Systemic Lupus ◽

Custom Made ◽

Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

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