scholarly journals Active Treatment for Idiopathic Adolescent Scoliosis (ACTIvATeS): a feasibility study

2015 ◽  
Vol 19 (55) ◽  
pp. 1-242 ◽  
Author(s):  
Mark A Williams ◽  
Peter J Heine ◽  
Esther M Williamson ◽  
Francine Toye ◽  
Melina Dritsaki ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cost Effectiveness ◽  
Idiopathic Scoliosis ◽  
Feasibility Study ◽  
Technology Assessment ◽  
Clinical Effectiveness ◽  
Health Technology ◽  
Feasibility Trial ◽  
Controlled Trials ◽  
Randomised Study

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.

scholarly journals Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262): clinical effectiveness systematic review and economic model

2016 ◽  
Vol 20 (39) ◽  
pp. 1-326 ◽  
Author(s):  
Rachel Archer ◽  
Paul Tappenden ◽  
Shijie Ren ◽  
Marrissa Martyn-St James ◽  
Rebecca Harvey ◽  
...  
Keyword(s):  
Systematic Review ◽  
Ulcerative Colitis ◽  
Cost Effectiveness ◽  
Economic Analysis ◽  
Citation Index ◽  
Clinical Effectiveness ◽  
Health Technology ◽  
Controlled Trials ◽  
Beneficial Effects ◽  
Biological Treatments

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.

scholarly journals ‘Not clinically effective but cost-effective’ - paradoxical conclusions in randomised controlled trials with ‘doubly null’ results: a cross-sectional study

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e029596 ◽  
Author(s):  
James Raftery ◽  
HC Williams ◽  
Aileen Clarke ◽  
Jim Thornton ◽  
John Norrie ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Technology Assessment ◽  
Randomised Controlled Trials ◽  
Cost Effective ◽  
Health Technology ◽  
Controlled Trials ◽  
Cross Sectional ◽  
Null Results ◽  
Health Technology Assessment Programme ◽  
Randomised Controlled

ObjectivesRandomised controlled trials in healthcare increasingly include economic evaluations. Some show small differences which are not statistically significant. Yet these sometimes come to paradoxical conclusions such as: ‘the intervention is not clinically effective’ but ‘is probably cost-effective’. This study aims to quantify the extent of non-significant results and the types of conclusions drawn from them.DesignCross-sectional retrospective analysis of randomised trials published by the UK’s National Institute for Health Research (NIHR) Health Technology Assessment programme. We defined as ‘doubly null’ those trials that found non-statistically significant differences in both primary outcome and cost per patient. Paradoxical was defined as concluding in favour of an intervention, usually compared with placebo or usual care. No human participants were involved. Our sample was 226 randomised trial projects published by the Health Technology Assessment programme 2004 to 2017. All are available free online.ResultsThe 226 projects contained 193 trials with a full economic evaluation. Of these 76 (39%) had at least one ‘doubly null’ comparison. These 76 trials contained 94 comparisons. In these 30 (32%) drew economic conclusions in favour of an intervention. Overall report conclusions split roughly equally between those favouring the intervention (14), and those favouring either the control (7) or uncertainty (9).DiscussionTrials with ‘doubly null’ results and paradoxical conclusions are not uncommon. The differences observed in cost and quality-adjustedlife year were small and non-statistically significant. Almost all these trials were also published in leading peer-reviewed journals. Although some guidelines for reporting economic results require cost-effectiveness estimates regardless of statistical significance, the interpretability of paradoxical results has nowhere been addressed.ConclusionsReconsideration is required of the interpretation of cost-effectiveness analyses in randomised controlled trials with ‘doubly null’ results, particularly when economics favours a novel intervention.

scholarly journals TRAPEZE: a randomised controlled trial of the clinical effectiveness and cost-effectiveness of chemotherapy with zoledronic acid, strontium-89, or both, in men with bony metastatic castration-refractory prostate cancer

2016 ◽  
Vol 20 (53) ◽  
pp. 1-288 ◽  
Author(s):  
Nicholas James ◽  
Sarah Pirrie ◽  
Ann Pope ◽  
Darren Barton ◽  
Lazaros Andronis ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cost Effectiveness ◽  
Zoledronic Acid ◽  
Randomised Controlled Trial ◽  
Technology Assessment ◽  
Cox Regression ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Health Technology ◽  
Randomised Controlled

BackgroundBony metastatic castration-refractory prostate cancer is associated with a poor prognosis and high morbidity. TRAPEZE was a two-by-two factorial randomised controlled trial of zoledronic acid (ZA) and strontium-89 (Sr-89), each combined with docetaxel. All have palliative benefits, are used to control bone symptoms and are used with docetaxel to prolong survival. ZA, approved on the basis of reducing skeletal-related events (SREs), is commonly combined with docetaxel in practice, although evidence of efficacy and cost-effectiveness is lacking. Sr-89, approved for controlling metastatic pain and reducing need for subsequent bone treatments, is generally palliatively used in patients unfit for chemotherapy. Phase II analysis confirmed the safety and feasibility of combining these agents. TRAPEZE aimed to determine the clinical effectiveness and cost-effectiveness of each agent.MethodsPatients were randomised to receive six cycles of docetaxel plus prednisolone: alone, with ZA, with a single Sr-89 dose after cycle 6, or with both. Primary outcomes were clinical progression-free survival (CPFS: time to pain progression, SRE or death) and cost-effectiveness. Secondary outcomes were SRE-free interval (SREFI), total SREs, overall survival (OS) and quality of life (QoL). Log-rank test and Cox regression modelling were used to determine clinical effectiveness. Cost-effectiveness was assessed from the NHS perspective and expressed as cost per additional quality-adjusted life-year (QALY). An additional analysis was carried out for ZA to reflect the availability of generic ZA.ResultsPatients: 757 randomised (median age 68.7 years; Eastern Cooperative Oncology Group scale score 0, 40%; 1, 52%; 2, 8%; prior radiotherapy, 45%); median prostate-specific antigen 143.78 ng/ml (interquartile range 50.8–353.9 ng/ml). Stratified log-rank analysis of CPFS was statistically non-significant for either agent (Sr-89,p = 0.11; ZA,p = 0.45). Cox regression analysis adjusted for stratification variables showed CPFS benefit for Sr-89 [hazard ratio (HR) 0.845, 95% confidence interval (CI) 0.72 to 0.99;p = 0.036] and confirmed no effect of ZA (p = 0.46). ZA showed a significant SREFI effect (HR 0.76; 95% CI 0.63 to 0.93;p = 0.008). Neither agent affected OS (Sr-89,p = 0.74; ZA,p = 0.91), but both increased total cost (vs. no ZA and no Sr-89, respectively); decreased post-trial therapies partly offset costs [net difference: Sr-89 £1341; proprietary ZA (Zometa®, East Hanover, NJ, USA) £1319; generic ZA £251]. QoL was maintained in all trial arms; Sr-89 (0.08 additional QALYs) and ZA (0.03 additional QALYs) showed slight improvements. The resulting incremental cost-effectiveness ratio (ICER) for Sr-89 was £16,590, with £42,047 per QALY for Zometa and £8005 per QALY for generic ZA.ConclusionStrontium-89 improved CPFS, but not OS. ZA did not improve CPFS or OS but significantly improved SREFI, mostly post progression, suggesting a role as post-chemotherapy maintenance therapy. QoL was well maintained in all treatment arms, with differing patterns of care resulting from the effects of Sr-89 on time to progression and ZA on SREFI and total SREs. The addition of Sr-89 resulted in additional cost and a small positive increase in QALYs, with an ICER below the £20,000 ceiling per QALY. The additional costs and small positive QALY changes in favour of ZA resulted in ICERs of £42,047 (Zometa) and £8005 for the generic alternative; thus, generic ZA represents a cost-effective option. Additional analyses on the basis of data from the Hospital Episode Statistics data set would allow corroborating the findings of this study. Further research into the use of ZA (and other bone-targeting therapies) with newer prostate cancer therapies would be desirable.Study registrationCurrent Controlled Trials ISRCTN12808747.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 53. See the NIHR Journals Library website for further project information.

scholarly journals Improving continence in children and young people with neurodisability: a systematic review and survey

2021 ◽  
Vol 25 (73) ◽  
pp. 1-258
Author(s):  
Helen Eke ◽  
Harriet Hunt ◽  
Susan Ball ◽  
Morwenna Rogers ◽  
Rebecca Whear ◽  
...  
Keyword(s):  
Systematic Review ◽  
Spinal Cord ◽  
Cost Effectiveness ◽  
Young People ◽  
Technology Assessment ◽  
Health Professionals ◽  
Current Practice ◽  
Health Technology ◽  
Care Staff ◽  
Children And Young People

Background Children and young people with neurodisability often need help to achieve socially acceptable bladder and bowel control. Approaches vary depending on whether or not the impairment results from spinal cord pathology that impairs motor control and sensation of the bladder and bowel. Currently, there is uncertainty about which interventions are effective. Objective The objective was to summarise the available evidence on and current practice for improving continence in children and young people with neurodisability. Design A systematic review of the effectiveness, cost-effectiveness and factors that modify intervention implementation, alongside a cross-sectional, online survey of current practice with health professionals, parent carers, school and care staff and young people with neurodisability. Results Twelve databases were searched in the review, resulting in 5756 references; 71 studies (72 papers) were included in the analyses. Most of the evidence was for children with spinal cord pathology, which involved evaluations of pharmacological approaches and surgical techniques, whereas the evidence pertaining to those with non-spinal-cord-related pathology tended to be for behavioural interventions. The methodological quality of studies was rated as being moderate to poor. There were three robust qualitative studies about the experience of continence among children with spinal cord pathology. We found substantial heterogeneity across the interventions that we evaluated in terms of quality, study design and outcomes measured. No economic studies were found. The results were synthesised narratively and reported in text and tables. We did not find any eligible studies evaluating interventions using toilet and clothing adaptations in the review, although the survey highlighted that these types of interventions are frequently used and considered. In total, 949 people responded to the survey: 202 health professionals, 605 parent carers, 122 school and social care staff, and 20 young people. The survey results illustrated the different roles that professionals have in improving continence, highlighting the importance of a multidisciplinary approach to supporting children and young people and their families. Clinicians employ a range of assessments and interventions to improve continence or independent toileting, depending on the needs of the child. Limitations Quantitative studies in the review were not methodologically robust. The survey had a risk of response bias. Conclusions Our research found a dearth of good-quality evidence for many of the interventions currently in use, and no evidence of experiences of implementing interventions for children with non-spinal-cord-related pathology. There was also no evidence of cost-effectiveness of any of the interventions. Future work There is a need to involve young people and families in the design of high-quality evaluative research for interventions that aim to improve continence. This is especially the case for children with autism and learning disability, who have been neglected in previous evaluative and qualitative research. We recommend better training for health, education and care professionals about toileting, informed by evidence and the lived experiences of children and their families. We recommend a joined-up multidisciplinary and holistic approach to improving continence to maximise independence, dignity and comfort. It is vital that children and young people with neurodisability have early access to regular, integrated assessment of their bladder and bowel health, and are fully supported with appropriate personalised treatment. Study registration This study is registered as PROSPERO CRD42018100572. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 73. See the NIHR Journals Library website for further project information.

scholarly journals Saline in Acute Bronchiolitis RCT and Economic evaluation: hypertonic saline in acute bronchiolitis – randomised controlled trial and systematic review

2015 ◽  
Vol 19 (66) ◽  
pp. 1-130 ◽  
Author(s):  
Mark L Everard ◽  
Daniel Hind ◽  
Kelechi Ugonna ◽  
Jennifer Freeman ◽  
Mike Bradburn ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trial ◽  
Adverse Events ◽  
Supportive Care ◽  
Technology Assessment ◽  
Controlled Trial ◽  
Health Technology ◽  
Controlled Trials ◽  
Acute Bronchiolitis ◽  
Randomised Controlled

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.

scholarly journals Early, specialist vocational rehabilitation to facilitate return to work after traumatic brain injury: the FRESH feasibility RCT

2018 ◽  
Vol 22 (33) ◽  
pp. 1-124 ◽  
Author(s):  
Kate Radford ◽  
Chris Sutton ◽  
Tracey Sach ◽  
Jain Holmes ◽  
Caroline Watkins ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Cost Effectiveness ◽  
Brain Injury ◽  
Technology Assessment ◽  
Work Ability ◽  
Self Efficacy ◽  
Clinical Effectiveness ◽  
Health Technology ◽  
Face To Face

BackgroundUp to 160,000 people incur traumatic brain injury (TBI) each year in the UK. TBI can have profound effects on many areas of human functioning, including participation in work. There is limited evidence of the clinical effectiveness and cost-effectiveness of vocational rehabilitation (VR) after injury to promote early return to work (RTW) following TBI.ObjectiveTo assess the feasibility of a definitive, multicentre, randomised controlled trial (RCT) of the clinical effectiveness and cost-effectiveness of early, specialist VR plus usual care (UC) compared with UC alone on work retention 12 months post TBI.DesignA multicentre, feasibility, parallel-group RCT with a feasibility economic evaluation and an embedded mixed-methods process evaluation. Randomisation was by remote computer-generated allocation.SettingThree NHS major trauma centres (MTCs) in England.ParticipantsAdults with TBI admitted for > 48 hours and working or studying prior to injury.InterventionsEarly specialist TBI VR delivered by occupational therapists (OTs) in the community using a case co-ordination model.Main outcome measuresSelf-reported RTW 12 months post randomisation, mood, functional ability, participation, work self-efficacy, quality of life and work ability. Feasibility outcomes included recruitment and retention rates. Follow-up was by postal questionnaires in two centres and face to face in one centre. Those collecting data were blind to treatment allocation.ResultsOut of 102 target participants, 78 were recruited (39 randomised to each arm), representing 39% of those eligible and 5% of those screened. Approximately 2.2 patients were recruited per site per month. Of those, 56% had mild injuries, 18% had moderate injuries and 26% had severe injuries. A total of 32 out of 45 nominated carers were recruited. A total of 52 out of 78 (67%) TBI participants responded at 12 months (UC,n = 23; intervention,n = 29), completing 90% of the work questions; 21 out of 23 (91%) UC respondents and 20 out of 29 (69%) intervention participants returned to work at 12 months. Two participants disengaged from the intervention. Face-to-face follow-up was no more effective than postal follow-up. RTW was most strongly related to social participation and work self-efficacy. It is feasible to assess the cost-effectiveness of VR. Intervention was delivered as intended and valued by participants. Factors likely to affect a definitive trial include deploying experienced OTs, no clear TBI definition or TBI registers, and repatriation of more severe TBI from MTCs, affecting recruitment of those most likely to benefit/least likely to drop out.LimitationsTarget recruitment was not reached, but mechanisms to achieve this in future studies were identified. Retention was lower than expected, particularly in UC, potentially biasing estimates of the 12-month RTW rate.ConclusionsThis study met most feasibility objectives. The intervention was delivered with high fidelity. When objectives were not met, strategies to ensure feasibility of a full trial were identified. Future work should test two-stage recruitment and include resources to recruit from ‘spokes’. A broader measure covering work ability, self-efficacy and participation may be a more sensitive outcome.Trial registrationCurrent Controlled Trials ISRCTN38581822.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 33. See the NIHR Journals Library website for further project information.

scholarly journals Adjunctive colposcopy technologies for examination of the uterine cervix – DySIS, LuViva Advanced Cervical Scan and Niris Imaging System: a systematic review and economic evaluation

2013 ◽  
Vol 17 (8) ◽  
pp. i-239 ◽  
Author(s):  
R Wade ◽  
E Spackman ◽  
M Corbett ◽  
S Walker ◽  
K Light ◽  
...  
Keyword(s):  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Citation Index ◽  
Imaging System ◽  
Cervical Screening ◽  
Clinical Effectiveness ◽  
Health Technology ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Higher Sensitivity

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.

scholarly journals Non-pharmacological treatments for stuttering in children and adults: a systematic review and evaluation of clinical effectiveness, and exploration of barriers to successful outcomes

2016 ◽  
Vol 20 (2) ◽  
pp. 1-302 ◽  
Author(s):  
Susan Baxter ◽  
Maxine Johnson ◽  
Lindsay Blank ◽  
Anna Cantrell ◽  
Shelagh Brumfitt ◽  
...  
Keyword(s):  
Systematic Review ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Science Citation Index ◽  
Citation Index ◽  
Clinical Effectiveness ◽  
Health Technology ◽  
Risk Of Bias ◽  
Science Citation ◽  
Qualitative Literature

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.

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