scholarly journals Orthotic management of instability of the knee related to neuromuscular and central nervous system disorders: systematic review, qualitative study, survey and costing analysis

2016 ◽  
Vol 20 (55) ◽  
pp. 1-262 ◽  
Author(s):  
Joanne O’Connor ◽  
Dorothy McCaughan ◽  
Catriona McDaid ◽  
Alison Booth ◽  
Debra Fayter ◽  
...  

BackgroundPatients who have knee instability that is associated with neuromuscular disease (NMD) and central nervous system (CNS) conditions can be treated using orthoses, such as knee–ankle–foot orthoses (KAFOs).ObjectivesTo assess existing evidence on the effectiveness of orthoses; patient perspectives; types of orthotic devices prescribed in the UK NHS; and associated costs.MethodsQualitative study of views of orthoses users – a qualitative in-depth interview study was undertaken. Data were analysed for thematic content. A coding scheme was developed and an inductive approach was used to identify themes. Systematic review – 18 databases were searched up to November 2014: MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, Cumulative Index to Nursing and Allied Health, EMBASE, PASCAL, Scopus, Science Citation Index, BIOSIS Previews, Physiotherapy Evidence Database, Recal Legacy, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Health Technology Assessment database, Cochrane Central Register of Controlled Trials, Conference Proceedings Citation Index: Science, Health Management Consortium, ClinicalTrials.gov, International Clinical Trials Registry Platform and National Technical Information Service. Studies of adults using an orthosis for instability of the knee related to NMD or a CNS disorder were included. Data were extracted and quality was assessed by two researchers. Narrative synthesis was undertaken. Survey and costing analysis – a web survey of orthotists, physiotherapists and rehabilitation medicine physicians was undertaken. Telephone interviews with orthotists informed a costing analysis.ResultsQualitative study – a total of 24 people participated. Potential for engagement in daily activities was of vital importance to patients; the extent to which their device enabled this was the yardstick by which it was measured. Patients’ prime desired outcome was a reduction in pain, falls or trips, with improved balance and stability. Effectiveness, reliability, comfort and durability were the most valued features of orthoses. Many expressed frustration with perceived deficiencies in service provision relating to appointment and administrative systems and referral pathways. Systematic review – a total of 21 studies (478 participants) were included of people who had post-polio syndrome, inclusion body myositis, were post stroke or had spinal cord injury. The studies evaluated KAFOs (mainly carbon fibre), stance control KAFO and hip KAFOs. All of the studies were at risk of bias and, in general, were poorly reported. Survey and costing analysis – in total, 238 health-care professionals responded. A range of orthoses is prescribed for knee instability that is related to NMD or CNS conditions, approximately half being custom-made. At least 50% of respondents thought that comfort and confidence in mobility were extremely important treatment outcomes. The cost of individual KAFOs was highly variable, ranging from £73 to £3553.ConclusionsVarious types of orthoses are used in the NHS to manage patients with NMD/CNS conditions and knee instability, both custom-made and prefabricated, of variable cost. Evidence on the effectiveness of the orthoses is limited, especially in relation to the outcomes that are important to orthoses users.LimitationsThe population included was broad, limiting any in-depth consideration of specific conditions. The response rate to the survey was low, and the costing analysis was based on some assumptions that may not reflect the true costs of providing KAFOs.Future workFuture work should include high-quality research on the effectiveness and cost-effectiveness of orthoses; development of a core set of outcome measures; further exploration of the views and experiences of patients; and the best models of service delivery.Study registrationThis study is registered as PROSPERO CRD42014010180. The qualitative study is registered as Current Controlled Trials ISRCTN65240228.FundingThe National Institute for Health Research Health Technology Assessment programme.

2016 ◽  
Vol 20 (39) ◽  
pp. 1-326 ◽  
Author(s):  
Rachel Archer ◽  
Paul Tappenden ◽  
Shijie Ren ◽  
Marrissa Martyn-St James ◽  
Rebecca Harvey ◽  
...  

BackgroundUlcerative colitis (UC) is the most common form of inflammatory bowel disease in the UK. UC can have a considerable impact on patients’ quality of life. The burden for the NHS is substantial.ObjectivesTo evaluate the clinical effectiveness and safety of interventions, to evaluate the incremental cost-effectiveness of all interventions and comparators (including medical and surgical options), to estimate the expected net budget impact of each intervention, and to identify key research priorities.Data sourcesPeer-reviewed publications, European Public Assessment Reports and manufacturers’ submissions. The following databases were searched from inception to December 2013 for clinical effectiveness searches and from inception to January 2014 for cost-effectiveness searches for published and unpublished research evidence: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library including the Cochrane Systematic Reviews Database, Cochrane Controlled Trials Register, Database of Abstracts of Reviews of Effects, the Health Technology Assessment database and NHS Economic Evaluation Database; ISI Web of Science, including Science Citation Index, and the Conference Proceedings Citation Index-Science and Bioscience Information Service Previews. The US Food and Drug Administration website and the European Medicines Agency website were also searched, as were research registers, conference proceedings and key journals.Review methodsA systematic review [including network meta-analysis (NMA)] was conducted to evaluate the clinical effectiveness and safety of named interventions. The health economic analysis included a review of published economic evaluations and the development of a de novo model.ResultsTen randomised controlled trials were included in the systematic review. The trials suggest that adult patients receiving infliximab (IFX) [Remicade®, Merck Sharp & Dohme Ltd (MSD)], adalimumab (ADA) (Humira®, AbbVie) or golimumab (GOL) (Simponi®, MSD) were more likely to achieve clinical response and remission than those receiving placebo (PBO). Hospitalisation data were limited, but suggested more favourable outcomes for ADA- and IFX-treated patients. Data on the use of surgical intervention were sparse, with a potential benefit for intervention-treated patients. Data were available from one trial to support the use of IFX in paediatric patients. Safety issues identified included serious infections, malignancies and administration site reactions. Based on the NMA, in the induction phase, all biological treatments were associated with statistically significant beneficial effects relative to PBO, with the greatest effect associated with IFX. For patients in response following induction, all treatments except ADA and GOL 100 mg at 32–52 weeks were associated with beneficial effects when compared with PBO, although these were not significant. The greatest effects at 8–32 and 32–52 weeks were associated with 100 mg of GOL and 5 mg/kg of IFX, respectively. For patients in remission following induction, all treatments except ADA at 8–32 weeks and GOL 50 mg at 32–52 weeks were associated with beneficial effects when compared with PBO, although only the effect of ADA at 32–52 weeks was significant. The greatest effects were associated with GOL (at 8–32 weeks) and ADA (at 32–52 weeks). The economic analysis suggests that colectomy is expected to dominate drug therapies, but for some patients, colectomy may not be considered acceptable. In circumstances in which only drug options are considered, IFX and GOL are expected to be ruled out because of dominance, while the incremental cost-effectiveness ratio for ADA versus conventional treatment is approximately £50,300 per QALY gained.LimitationsThe health economic model is subject to several limitations: uncertainty associated with extrapolating trial data over a lifetime horizon, the model does not consider explicit sequential pathways of non-biological treatments, and evidence relating to complications of colectomy was identified through consideration of approaches used within previous models rather than a full systematic review.ConclusionsAdult patients receiving IFX, ADA or GOL were more likely to achieve clinical response and remission than those receiving PBO. Further data are required to conclusively demonstrate the effect of interventions on hospitalisation and surgical outcomes. The economic analysis indicates that colectomy is expected to dominate medical treatments for moderate to severe UC.Study registrationThis study is registered as PROSPERO CRD42013006883.FundingThe National Institute for Health Research Health Technology Assessment programme.


2006 ◽  
Vol 22 (4) ◽  
pp. 408-418 ◽  
Author(s):  
Catriona M. Mc Daid ◽  
Suzanne Hartley ◽  
Anne-Marie Bagnall ◽  
Gill Ritchie ◽  
Kate Light ◽  
...  

Objectives: The aim of this study was to conduct a systematic review of the evidence for treatments for retinoblastoma in children.Methods: Seventeen electronic databases were searched. Two reviewers independently selected studies. Studies of participants diagnosed with childhood retinoblastoma, any interventions, and all clinical outcomes were eligible. Randomized and nonrandomized controlled trials and cohort studies with clear comparisons between treatment groups were included. Methodological quality was assessed.Results: Thirty-one observational comparative studies were included, of which twenty-seven were retrospective. The methodological quality was generally poor, with a high risk of selection bias in all studies. Although there were high levels of treatment success in many of the studies, due to the limitations of the evidence identified, it was not possible to make meaningful and robust conclusions about the relative effectiveness of different treatment approaches for retinoblastoma in children.Conclusions: Good quality randomized controlled trials are required. Where controlled trials are not feasible, only high quality prospective, nonrandomized studies should be given consideration, due to the generally higher risk of bias in retrospective studies.


BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e030596 ◽  
Author(s):  
Kathryn S Taylor ◽  
Julie Mclellan ◽  
Jan Y Verbakel ◽  
Jeffrey K Aronson ◽  
Daniel S Lasserson ◽  
...  

ObjectiveTo evaluate the effects of drug interventions that may modify the progression of chronic kidney disease (CKD) in adults with CKD stages 3 and 4.DesignSystematic review and meta-analysis.MethodsSearching MEDLINE, EMBASE, Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, International Clinical Trials Registry Platform, Health Technology Assessment, Science Citation Index, Social Sciences Citation Index, Conference Proceedings Citation Index and Clinical Trials Register, from March 1999 to July 2018, we identified randomised controlled trials (RCTs) of drugs for hypertension, lipid modification, glycaemic control and sodium bicarbonate, compared with placebo, no drug or a drug from another class, in ≥40 adults with CKD stages 3 and/or 4, with at least 2 years of follow-up and reporting renal function (primary outcome), proteinuria, adverse events, maintenance dialysis, transplantation, cardiovascular events, cardiovascular mortality or all-cause mortality. Two reviewers independently screened citations and extracted data. For continuous outcomes, we used the ratio of means (ROM) at the end of the trial in random-effects meta-analyses. We assessed methodological quality with the Cochrane Risk of Bias Tool and confidence in the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework.ResultsWe included 35 RCTs and over 51 000 patients. Data were limited, and heterogeneity varied. Final renal function (estimated glomerular filtration rate) was 6% higher in those taking glycaemic control drugs (ROM 1.06, 95% CI 1.02 to 1.10, I2=0%, low GRADE confidence) and 4% higher in those taking lipid-modifying drugs (ROM 1.04, 95% CI 1.00 to 1.08, I2=88%, very low GRADE confidence). For RCTs of antihypertensive drugs, there were no significant differences in renal function. Treatment with lipid-modifying drugs led to a 36% reduction in cardiovascular disease and 26% reduction in all-cause mortality.ConclusionsGlycaemic control and lipid-modifying drugs may slow the progression of CKD, but we found no pooled evidence of benefit nor harm from antihypertensive drugs. However, given the data limitations, further research is needed to confirm these findings.PROSPERO registration numberCRD42015017501.


2015 ◽  
Vol 19 (66) ◽  
pp. 1-130 ◽  
Author(s):  
Mark L Everard ◽  
Daniel Hind ◽  
Kelechi Ugonna ◽  
Jennifer Freeman ◽  
Mike Bradburn ◽  
...  

BackgroundAcute bronchiolitis is the most common cause of hospitalisation in infancy. Supportive care and oxygen are the cornerstones of management. A Cochrane review concluded that the use of nebulised 3% hypertonic saline (HS) may significantly reduce the duration of hospitalisation.ObjectiveTo test the hypothesis that HS reduces the time to when infants were assessed as being fit for discharge, defined as in air with saturations of > 92% for 6 hours, by 25%.DesignParallel-group, pragmatic randomised controlled trial, cost–utility analysis and systematic review.SettingTen UK hospitals.ParticipantsInfants with acute bronchiolitis requiring oxygen therapy were allocated within 4 hours of admission.InterventionsSupportive care with oxygen as required, minimal handling and fluid administration as appropriate to the severity of the disease, 3% nebulised HS every ± 6 hours.Main outcome measuresThe trial primary outcome was time until the infant met objective discharge criteria. Secondary end points included time to discharge and adverse events. The costs analysed related to length of stay (LoS), readmissions, nebulised saline and other NHS resource use. Quality-adjusted life-years (QALYs) were estimated using an existing utility decrement derived for hospitalisation in children, together with the time spent in hospital in the trial.Data sourcesWe searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and other databases from inception or from 2010 onwards, searched ClinicalTrials.gov and other registries and hand-searchedChest,PaediatricsandJournal of Paediatricsto January 2015.Review methodsWe included randomised/quasi-randomised trials which compared HS versus saline (± adjunct treatment) or no treatment. We used a fixed-effects model to combine mean differences for LoS and assessed statistical heterogeneity using theI2statistic.ResultsThe trial randomised 158 infants to HS (n = 141 analysed) and 159 to standard care (n = 149 analysed). There was no difference between the two arms in the time to being declared fit for discharge [median 76.6 vs. 75.9 hours, hazard ratio (HR) 0.95, 95% confidence interval (CI) 0.75 to 1.20] or to actual discharge (median 88.5 vs. 88.7 hours, HR 0.97, 95% CI 0.76 to 1.23). There was no difference in adverse events. One infant developed bradycardia with desaturation associated with HS. Mean hospital costs were £2595 and £2727 for the control and intervention groups, respectively (p = 0.657). Incremental QALYs were 0.0000175 (p = 0.757). An incremental cost-effectiveness ratio of £7.6M per QALY gained was not appreciably altered by sensitivity analyses. The systematic review comprised 15 trials (n = 1922) including our own. HS reduced the mean LoS by –0.36 days (95% CI –0.50 to –0.22 days). High levels of heterogeneity (I2 = 78%) indicate that the result should be treated cautiously.ConclusionsIn this trial, HS had no clinical benefit on LoS or readiness for discharge and was not a cost-effective treatment for acute bronchiolitis. Claims that HS achieves small reductions in LoS must be treated with scepticism.Future workWell-powered randomised controlled trials of high-flow oxygen are needed.Study registrationThis study is registered as NCT01469845 and CRD42014007569.Funding detailsThis project was funded by the NIHR Health Technology Assessment (HTA) programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 66. See the HTA programme website for further project information.


2013 ◽  
Vol 17 (8) ◽  
pp. i-239 ◽  
Author(s):  
R Wade ◽  
E Spackman ◽  
M Corbett ◽  
S Walker ◽  
K Light ◽  
...  

BackgroundWomen in England (aged 25–64 years) are invited for cervical screening every 3–5 years to assess for cervical intraepithelial neoplasia (CIN) or cancer. CIN is a term describing abnormal changes in the cells of the cervix, ranging from CIN1 to CIN3, which is precancerous. Colposcopy is used to visualise the cervix. Three adjunctive colposcopy technologies for examination of the cervix have been included in this assessment: Dynamic Spectral Imaging System (DySIS), the LuViva Advanced Cervical Scan and the Niris Imaging System.ObjectiveTo determine the clinical effectiveness and cost-effectiveness of adjunctive colposcopy technologies for examination of the uterine cervix for patients referred for colposcopy through the NHS Cervical Screening Programme.Data sourcesSixteen electronic databases [Allied and Complementary Medicine Database (AMED), BIOSIS Previews, Cochrane Database of Systematic Reviews (CDSR), Cochrane Central Register of Controlled Trials (CENTRAL), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Database of Abstracts of Reviews of Effects (DARE), EMBASE, Health Management Information Consortium (HMIC), Health Technology Assessment (HTA) database; Inspec, Inside Conferences, MEDLINE, NHS Economic Evaluation Database (NHS EED), PASCAL, Science Citation Index Expanded (SCIE) and Science Citation Index (SCI) – Conference Proceedings], and two clinical trial registries [ClinicalTrials.gov and Current Controlled Trials (CCT)] were searched to September–October 2011.Review methodsStudies comparing DySIS, LuViva or Niris with conventional colposcopy were sought; a narrative synthesis was undertaken. A decision-analytic model was developed, which measured outcomes in terms of quality-adjusted life-years (QALYs) and costs were evaluated from the perspective of the NHS and Personal Social Services with a time horizon of 50 years.ResultsSix studies were included: two studies of DySIS, one study of LuViva and three studies of Niris. The DySIS studies were well reported and had a low risk of bias; they found higher sensitivity with DySIS (both the DySISmap alone and in combination with colposcopy) than colposcopy alone for identifying CIN2+ disease, although specificity was lower with DySIS. The studies of LuViva and Niris were poorly reported and had limitations, which indicated that their results were subject to a high risk of bias; the results of these studies cannot be considered reliable. The base-case cost-effectiveness analysis suggests that both DySIS treatment options are less costly and more effective than colposcopy alone in the overall weighted population; these results were robust to the ranges tested in the sensitivity analysis. DySISmap alone was more costly and more effective in several of the referral groups but the incremental cost-effectiveness ratio (ICER) was never higher than £1687 per QALY. DySIS plus colposcopy was less costly and more effective in all reasons for referral. Only indicative analyses were carried out on Niris and LuViva and no conclusions could be made on their cost-effectiveness.LimitationsThe assessment is limited by the available evidence on the new technologies, natural history of the disease area and current treatment patterns.ConclusionsDySIS, particularly in combination with colposcopy, has higher sensitivity than colposcopy alone. There is no reliable evidence on the clinical effectiveness of LuViva and Niris. DySIS plus colposcopy appears to be less costly and more effective than both the DySISmap alone and colposcopy alone; these results were robust to the sensitivity analyses undertaken. Given the lack of reliable evidence on LuViva and Niris, no conclusions on their potential cost-effectiveness can be drawn. There is some uncertainty about how generalisable these findings will be to the population of women referred for colposcopy in the future, owing to the introduction of the human papillomavirus (HPV) triage test and uptake of the HPV vaccine.Study registrationPROSPERO Record CRD42011001614.FundingThe National Institute for Health Research Health Technology Assessment programme.


2016 ◽  
Vol 20 (2) ◽  
pp. 1-302 ◽  
Author(s):  
Susan Baxter ◽  
Maxine Johnson ◽  
Lindsay Blank ◽  
Anna Cantrell ◽  
Shelagh Brumfitt ◽  
...  

BackgroundDespite many years of research, there is no certainty regarding the cause of stuttering. Although numerous interventions have been developed, a broad-based systematic review across all forms of intervention for adults and children was needed including views and perceptions of people who stutter.ObjectiveThe aims of the study were to report the clinical effectiveness of interventions for people who stutter (or clutter), to examine evidence regarding the views of people who stutter and the views of professionals regarding interventions.Data sourcesA systematic review of quantitative and qualitative literature was carried out between August 2013 and April 2014. The following electronic databases were searched: (1) MEDLINE, (2) EMBASE, (3) The Cochrane Library (including The Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, Health Technology Assessment Database and NHS Economic Evaluations Database), (4) PsycINFO, (5) Science Citation Index, (6) Social Science Citation Index, (7) Cumulative Index to Nursing and Allied Health Literature, (8) ASSIA, (9) Linguistics and Language Behavior Abstracts, (10) Sociological Abstracts and (11) the EPPI Centre. Reference lists of included papers and other reviews were screened and also key journals in the subject area were hand-searched.Review methodsThe searches aimed to identify (1) evidence of clinical effectiveness in populations of pre-school children, school-aged children, adolescents and adults, and (2) data relating to perceptions of barriers and facilitators to intervention clinical effectiveness among staff and people who stutter. A metasynthesis of the two linked elements via development of a conceptual model was also carried out to provide further interpretation of the review findings.ResultsA systematic search of the literature identified a large number of potentially relevant studies. Of these, 111 studies examining the clinical effectiveness of interventions, 25 qualitative papers and one mixed-methods paper met the criteria for inclusion in this review. Review of the effectiveness literature indicated evidence of positive outcomes across all types of interventions. Virtually all evidence we identified reported at least some positive effect for some participants. However, there was evidence of considerable individual variation in outcome for study participants. The qualitative literature highlighted the need for programmes to be tailored to individual need with variation at the levels of the intervention, the individual and interpersonal/social elements. Metasynthesis of the data highlighted the complexity of elements that need to be considered in evaluation of long-term impacts following stuttering interventions.LimitationsAround two-thirds of the studies were considered to be at higher risk of bias. The heterogeneous nature and variability in outcomes meant that we were unable to complete a meta-analysis.ConclusionsAlthough much of the evidence we identified was from studies at risk of bias, it is suggested that most available interventions for stuttering may be of benefit to at least some people who stutter. There is a requirement for greater clarity regarding what the core outcomes following stuttering intervention should be and also enhanced understanding of the process whereby interventions effect change. Further analysis of those for whom interventions have not produced a significant benefit may provide additional insights into the complex intervention–outcomes pathway.Study registrationThis study is registered as PROSPERO CRD42013004861.FundingThe National Institute for Health Research Health Technology Assessment programme.


2022 ◽  
Vol 5 ◽  
pp. 1
Author(s):  
Alan Scarry ◽  
Jennifer Rice ◽  
Eibhlís M O' Connor ◽  
Audrey C Tierney

Background: Mobile technology has grown at an exceptional rate and is now a huge part of our daily living. This use of mobile technology has opened up new possibilities in treating health, with almost half of the current applications linked to the mHealth sector. In particular, dietary measurement, applications have become very accessible and very popular. As dietary issues have become more prevalent, more mobile and mHealth applications offer various solutions. This systematic review aims to address if the use of such mobile applications or mobile health technology can improve diet quality in adults that interact with them. Methods: A systematic review of randomised controlled trials (RCTs) and non-randomised controlled trials (NRCTs) will be conducted. The Cumulative Index to Nursing and Allied Health Literature (Cinahl), The American Psychological Association’s (APA Psycinfo), and PubMed will be searched from January 2010 to November 2021. Primary outcomes will include identifying if adults who use mobile applications and health technology improve their diet quality compared to adults who do not use this technology. Study selection will follow the Preferred Reporting Items for Systematic Reviews and MetaAnalyses (PRISMA) guidelines. The methodological appraisal of the studies will be assessed independently by two different reviewers (AS and JR) using the Cochrane Risk-of-Bias Tool for RCTs and the Risk-of Bias In Non-Randomised Studies Tool for NRCTs. Ethics and dissemination: Ethical approval is not essential for this systematic review. Only data from studies that are publically available from previously published studies will be used. The findings of this systematic review will be submitted for publication in a peer-reviewed journal and presented at relevant conferences. PROSPERO registration: CRD42021240224 (01/03/2021).


2015 ◽  
Vol 19 (55) ◽  
pp. 1-242 ◽  
Author(s):  
Mark A Williams ◽  
Peter J Heine ◽  
Esther M Williamson ◽  
Francine Toye ◽  
Melina Dritsaki ◽  
...  

BackgroundThe feasibility of conducting a definitive randomised controlled trial (RCT) evaluating the clinical effectiveness and cost-effectiveness of scoliosis-specific exercises (SSEs) for adolescent idiopathic scoliosis (AIS) is uncertain.ObjectivesThe aim of this study was to assess the feasibility of conducting a large, multicentre trial of SSE treatment for patients with AIS, in comparison with standard care, and to refine elements of the study design. The objectives were to (1) update a systematic review of controlled trials evaluating the efficacy of SSE in AIS; (2) survey UK orthopaedic surgeons and physiotherapists to determine current practice, patient populations and equipoise; (3) randomise 50 adolescents to a feasibility trial of either usual care or SSE interventions across a range of sites; (4) develop, document and assess acceptability and adherence of interventions; (5) assess and describe training requirements of physiotherapists; and (6) gain user input in all relevant stages of treatment and protocol design.DesignMulticomponent feasibility study including UK clinician survey, systematic literature review and a randomised feasibility trial.SettingThe randomised feasibility study involved four secondary care NHS trusts providing specialist care for patients with AIS.ParticipantsThe randomised feasibility study recruited people aged 10–16 years with mild AIS (Cobb angle of < 50°).InterventionsThe randomised study allocated participants to standard practice of advice and education or a physiotherapy SSE programme supported by a home exercise plan. Our choice of intervention was informed by a systematic review of exercise interventions for AIS.Main outcome measuresThe main outcome was feasibility of recruitment to the randomised study. Other elements were to inform choice of outcomes for a definitive trial and included curve severity, quality of life, requirement for surgery/brace, adverse events, psychological symptoms, costs and health utilities.ResultsA UK survey of orthopaedic consultants and physiotherapists indicated a wide variation in current provision of exercise therapy through physiotherapy services. It also found that clinicians from at least 15 centres would be willing to have their patients involved in a full study. A systematic review update found five new studies that were generally of low quality but showed some promise of effectiveness of SSE. The randomised study recruited 58 patients from four NHS trusts over 11 months and exceeded the pre-specified target recruitment rate of 1.4 participants per centre per month, with acceptable 6-month follow-up (currently 73%). Adherence to treatment was variable (56% of participants completed treatment offered). The qualitative study found the exercise programme to be highly acceptable. We learnt important lessons from patient and public involvement during the study in terms of study and intervention presentation, as well as practical elements such as scheduling of intervention sessions.ConclusionsA definitive RCT evaluating clinical effectiveness and cost-effectiveness of SSE for idiopathic scoliosis is warranted and feasible. Such a RCT is a priority for future work in the area. There is a sufficiently large patient base, combined with willingness to be randomised within specialist UK centres. Interventions developed during the feasibility study were acceptable to patients, families and physiotherapists and can be given within the affordability envelope of current levels of physiotherapy commissioning.Trial registrationCurrent Controlled Trials ISRCTN90480705.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 55. See the NIHR Journals Library website for further project information.


2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Minettchen Herchenröder ◽  
Denise Wilfling ◽  
Jost Steinhäuser

Abstract Background Flatfoot is characterised by the falling of the medial longitudinal arch, eversion of the hindfoot and abduction of the loaded forefoot. Furthermore, flatfoot leads to a variety of musculoskeletal symptoms in the lower extremity, such as knee or hip pain. The standard conservative treatment for flatfoot deformity is exercise therapy or treatment with foot orthoses. Foot orthoses are prescribed for various foot complaints. However, the evidence for the provision of foot orthoses is inconsistent. The aim of this systematic review is to synthesize the evidence of foot orthoses for adults with flatfoot. Methods A computerized search was conducted in August 2021, using the databases PubMed, Scopus, Pedro, Cochrane Library, and the Cochrane Central Register of Controlled Trials. Intervention studies of any design investigating the effects of foot orthoses were included, apart from case studies. Two independent reviewers assessed all search results to identify eligible studies and to assess their methodological quality. Results A total of 110 studies were identified through the database search. 12 studies met the inclusion criteria and were included in the review. These studies investigated prefabricated and custom-made foot orthoses, evaluating stance and plantar pressure during gait. The sample sizes of the identified studies ranged from 8 to 80. In most of the studies, the methodological quality was low and a lack of information was frequently detected. Conclusion There is a lack of evidence on the effect of foot orthoses for flatfoot in adults. This review illustrates the importance of conducting randomized controlled trials and the comprehensive development of guidelines for the prescription of foot orthoses. Given the weak evidence available, the common prescription of foot orthoses is somewhat surprising.


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