scholarly journals Surveillance versus ablation for incidentally diagnosed small renal tumours: the SURAB feasibility RCT

2017 ◽  
Vol 21 (81) ◽  
pp. 1-68 ◽  
Author(s):  
Naeem Soomro ◽  
Jan Lecouturier ◽  
Deborah D Stocken ◽  
Jing Shen ◽  
Ann Marie Hynes ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Active Surveillance ◽  
Feasibility Study ◽  
Technology Assessment ◽  
Randomised Trial ◽  
Health Technology ◽  
Serious Adverse Events ◽  
Design Work ◽  
Renal Tumours ◽  
Stage 1

Background There is uncertainty around the appropriate management of small renal tumours. Treatments include partial nephrectomy, ablation and active surveillance. Objectives To explore the feasibility of a randomised trial of ablation versus active surveillance. Design Two-stage feasibility study: stage 1 – clinician survey and co-design work; and stage 2 – randomised feasibility study with qualitative and economic components. Methods Stage 1 – survey of radiologists and urologists, and development of patient information materials. Stage 2 – patients identified across eight UK centres with small renal tumours (< 4 cm) were randomised (1 : 1 ratio) to ablation or active surveillance in an unblinded manner. Randomisation was carried out by a central computer system. The primary objective was to determine willingness to participate and to randomise a target of 60 patients. The qualitative and economic data were collected separately. Results The trial was conducted across eight centres, with a site-specific period of recruitment ranging from 3 to 11 months. Of the 154 patients screened, 36 were eligible and were provided with study details. Seven agreed to be randomised and one patient was found ineligible following biopsy results. Six patients (17% of those eligible) were randomised: three patients received ablation and no serious adverse events were recorded. The 3- and 6-month data were collected for four (67%) and three (50%) out of the six patients, respectively. The qualitative substudy identified factors directly impacting on the recruitment of this trial. These included patient and clinician preferences, organisational factors (variation in clinical pathway) and standard treatment not included. The health economic questionnaire was designed and piloted; however, the sample size of recruited patients was insufficient to draw a conclusion on the feasibility of the health economics. Conclusions The trial did not meet the criteria for progression and the recruitment rate was lower than hypothesised, demonstrating that a full trial is presently not possible. The qualitative study identified factors that led to variation in recruitment across the sites. Implementation of organisational and operational measures can increase recruitment in any future trial. There was insufficient information to conduct a full economic analysis. Trial registration Current Controlled Trials ISRCTN31161700. 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. 21, No. 81. See the NIHR Journals Library website for further project information.

Routine use of progesterone does not prevent miscarriage

BMJ ◽  
2019 ◽  
pp. l5721
Author(s):  
Rob Cook ◽  
Vaughan Thomas ◽  
Rachel Taft
Keyword(s):  
Health Technology Assessment ◽  
Early Pregnancy ◽  
Technology Assessment ◽  
Randomised Trial ◽  
Health Technology ◽  
Assessment Programme ◽  
Link Type ◽  
Health Technology Assessment Programme

The studyCoomarasamy A, Devall AJ, Cheed V, et al. A randomised trial of progesterone in women with bleeding in early pregnancy N Engl J Med 2019;380:1815-24.This project was funded by the NIHR Health Technology Assessment Programme (project number 12/167/26).To read the full NIHR Signal, go to https://discover.dc.nihr.ac.uk/content/signal-000792/miscarriage-not-prevented-by-routine-use-of-progesterone

scholarly journals Probiotics for Antibiotic-Associated Diarrhoea (PAAD): a prospective observational study of antibiotic-associated diarrhoea (including Clostridium difficile-associated diarrhoea) in care homes

2014 ◽  
Vol 18 (63) ◽  
pp. 1-84 ◽  
Author(s):  
Kerenza Hood ◽  
Jacqui Nuttall ◽  
David Gillespie ◽  
Victoria Shepherd ◽  
Fiona Wood ◽  
...  
Keyword(s):  
Clostridium Difficile ◽  
Observational Study ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Care Home ◽  
Health Technology ◽  
Care Homes ◽  
Antibiotic Prescribing ◽  
Stage 1 ◽  
Antibiotic Associated Diarrhoea

BackgroundAntibiotic prescribing rates in care homes are higher than in the general population. Antibiotics disrupt the normal gut flora, sometimes causing antibiotic-associated diarrhoea (AAD).Clostridium difficile(Hall and O’Toole 1935) Prévot 1938 is the most commonly identified cause of AAD. Little is known either about the frequency or type of antibiotics prescribed in care homes or about the incidence and aetiology of AAD in this setting.ObjectivesThe Probiotics for Antibiotic-Associated Diarrhoea (PAAD) study was designed as a two-stage study. PAAD stage 1 aimed to (1) prospectively describe antibiotic prescribing in care homes; (2) determine the incidence ofC. difficilecarriage and AAD (includingC. difficile-associated diarrhoea); and (3) to consider implementation challenges and establish the basis for a sample size estimation for a randomised controlled trial (RCT) of probiotic administration with antibiotics to prevent AAD in care homes. If justified by PAAD stage 1, the RCT would be implemented in PAAD stage 2. However, as a result of new evidence regarding the clinical effectiveness of probiotics on the incidence of AAD, a decision was taken not to proceed with PAAD stage 2.DesignPAAD stage 1 was a prospective observational cohort study in care homes in South Wales with up to 12 months’ follow-up for each resident.SettingRecruited care homes had management and owner’s agreement to participate and three or more staff willing to take responsibility for implementing the study.ParticipantsEleven care homes were recruited, but one withdrew before any residents were recruited. A total of 279 care home residents were recruited to the observational study and 19 withdrew, 16 (84%) because of moving to a non-participating care home.Main outcome measuresThe primary outcomes were the rate of antibiotic prescribing, incidence of AAD, defined as three or more loose stools (type 5–7 on the Bristol Stool Chart) in a 24-hour period, andC. difficilecarriage confirmed on stool culture.ResultsStool samples were obtained at study entry from 81% of participating residents. Over half of the samples contained antibiotic-resistant isolates, with Enterobacteriaceae resistant to ciprofloxacin in 47%. Residents were prescribed an average of 2.16 antibiotic prescriptions per year [95% confidence interval (CI) 1.90 to 2.46]. Antibiotics were less likely to be prescribed to residents from dual-registered homes. The incidence of AAD was 0.57 (95% CI 0.41 to 0.81) episodes per year among those residents who were prescribed antibiotics. AAD was more likely in residents who were prescribed co-amoxiclav than other antibiotics and in those residents who routinely used incontinence pads. AAD was less common in residents from residential homes.ConclusionsCare home residents, particularly in nursing homes, are frequently prescribed antibiotics and often experience AAD. Antibiotic resistance, including ciprofloxacin resistance, is common in Enterobacteriaceae isolated from the stool of care home residents. Co-amoxiclav is associated with greater risk of AAD than other commonly prescribed antibiotics.Trial registrationCurrent Controlled Trials ISRCTN 7954844.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. 18, No. 63. See the NIHR Journals Library website for further project information.

scholarly journals E-cigarettes helped more smokers quit than nicotine replacement therapy

BMJ ◽  
2019 ◽  
pp. l2036 ◽  
Author(s):  
Rob Cook ◽  
Peter Davidson ◽  
Rosie Martin
Keyword(s):  
Cancer Research ◽  
Health Technology Assessment ◽  
Replacement Therapy ◽  
Nicotine Replacement Therapy ◽  
Technology Assessment ◽  
Randomised Trial ◽  
Health Technology ◽  
Nicotine Replacement ◽  
Assessment Programme ◽  
Health Technology Assessment Programme

The studyHajek P, Phillips-Waller A, Przulj D, et al. A randomised trial of e-cigarettes versus nicotine-replacement therapy. N Engl J Med 2019;380:629-37.This trial was funded by the NIHR Health Technology Assessment Programme (12/167/135) and by Cancer Research UK.To read the full NIHR Signal, go to https://discover.dc.nihr.ac.uk/content/signal-000757/e-cigarettes-helped-more-smokers-quit-than-nicotine-replacement-therapy

scholarly journals Aquatic therapy for children with Duchenne muscular dystrophy: a pilot feasibility randomised controlled trial and mixed-methods process evaluation

2017 ◽  
Vol 21 (27) ◽  
pp. 1-120 ◽  
Author(s):  
Daniel Hind ◽  
James Parkin ◽  
Victoria Whitworth ◽  
Saleema Rex ◽  
Tracey Young ◽  
...  
Keyword(s):  
Duchenne Muscular Dystrophy ◽  
Randomised Controlled Trial ◽  
Muscular Dystrophy ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Health Technology ◽  
Aquatic Therapy ◽  
Randomised Controlled

BackgroundDuchenne muscular dystrophy (DMD) is a rare disease that causes the progressive loss of motor abilities such as walking. Standard treatment includes physiotherapy. No trial has evaluated whether or not adding aquatic therapy (AT) to land-based therapy (LBT) exercises helps to keep muscles strong and children independent.ObjectivesTo assess the feasibility of recruiting boys with DMD to a randomised trial evaluating AT (primary objective) and to collect data from them; to assess how, and how well, the intervention and trial procedures work.DesignParallel-group, single-blind, randomised pilot trial with nested qualitative research.SettingSix paediatric neuromuscular units.ParticipantsChildren with DMD aged 7–16 years, established on corticosteroids, with a North Star Ambulatory Assessment (NSAA) score of 8–34 and able to complete a 10-m walk without aids/assistance. Exclusions: > 20% variation between baseline screens 4 weeks apart and contraindications.InterventionsParticipants were allocated on a 1 : 1 ratio to (1) optimised, manualised LBT (prescribed by specialist neuromuscular physiotherapists) or (2) the same plus manualised AT (30 minutes, twice weekly for 6 months: active assisted and/or passive stretching regime; simulated or real functional activities; submaximal exercise). Semistructured interviews with participants, parents (n = 8) and professionals (n = 8) were analysed using Framework analysis. An independent rater reviewed patient records to determine the extent to which treatment was optimised. A cost-impact analysis was performed. Quantitative and qualitative data were mixed using a triangulation exercise.Main outcome measuresFeasibility of recruiting 40 participants in 6 months, participant and therapist views on the acceptability of the intervention and research protocols, clinical outcomes including NSAA, independent assessment of treatment optimisation and intervention costs.ResultsOver 6 months, 348 children were screened – most lived too far from centres or were enrolled in other trials. Twelve (30% of target) were randomised to AT (n = 8) or control (n = 4). People in the AT (n = 8) and control (n = 2: attrition because of parental report) arms contributed outcome data. The mean change in NSAA score at 6 months was –5.5 [standard deviation (SD) 7.8] for LBT and –2.8 (SD 4.1) in the AT arm. One boy suffered pain and fatigue after AT, which resolved the same day. Physiotherapists and parents valued AT and believed that it should be delivered in community settings. The independent rater considered AT optimised for three out of eight children, with other children given programmes that were too extensive and insufficiently focused. The estimated NHS costs of 6-month service were between £1970 and £2734 per patient.LimitationsThe focus on delivery in hospitals limits generalisability.ConclusionsNeither a full-scale frequentist randomised controlled trial (RCT) recruiting in the UK alone nor a twice-weekly open-ended AT course delivered at tertiary centres is feasible. Further intervention development research is needed to identify how community-based pools can be accessed, and how families can link with each other and community physiotherapists to access tailored AT programmes guided by highly specialised physiotherapists. Bayesian RCTs may be feasible; otherwise, time series designs are recommended.Trial registrationCurrent Controlled Trials ISRCTN41002956.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. 21, No. 27. See the NIHR Journals Library website for further project information.

scholarly journals HEALTH TECHNOLOGY ASSESSMENT OF MEDICAL DEVICES: A SURVEY OF NON-EUROPEAN UNION AGENCIES

2015 ◽  
Vol 31 (3) ◽  
pp. 154-165 ◽  
Author(s):  
Oriana Ciani ◽  
Britni Wilcher ◽  
Carl Rudolf Blankart ◽  
Maximilian Hatz ◽  
Valentina Prevolnik Rupel ◽  
...  
Keyword(s):  
European Union ◽  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Evidence Synthesis ◽  
Health Technology ◽  
Site Assessment ◽  
Telephone Interviews ◽  
Stage 1 ◽  
Methodological Guidelines

Objectives: The aim of this study was to review and compare current health technology assessment (HTA) activities for medical devices across non-European Union HTA agencies.Methods: HTA activities for medical devices were evaluated from three perspectives: organizational structure, processes, and methods. Agencies were primarily selected upon membership of existing HTA networks. The data collection was performed in two stages: stage 1–agency Web-site assessment using a standardized questionnaire, followed by review and validation of the collected data by a representative of the agency; and stage 2–semi-structured telephone interviews with key informants of a sub-sample of agencies.Results: In total, thirty-six HTA agencies across twenty non-EU countries assessing medical devices were included. Twenty-seven of thirty-six (75 percent) agencies were judged at stage 1 to have adopted HTA-specific approaches for medical devices (MD-specific agencies) that were largely organizational or procedural. There appeared to be few differences in the organization, process and methods between MD-specific and non–MD-specific agencies. Although the majority (69 percent) of both categories of agency had specific methods guidance or policy for evidence submission, only one MD-specific agency had developed methodological guidelines specific to medical devices. In stage 2, many MD-specific agencies cited insufficient resources (budget, skilled employees), lack of coordination (between regulator and reimbursement bodies), and the inability to generalize findings from evidence synthesis to be key challenges in the HTA of medical devices.Conclusions: The lack of evidence for differentiation in scientific methods for HTA of devices raises the question of whether HTA needs to develop new methods for medical devices but rather adapt existing methodological approaches. In contrast, organizational and/or procedural adaptation of existing HTA agency frameworks to accommodate medical devices appear relatively commonplace.

scholarly journals A support package for parents of excessively crying infants: development and feasibility study

2019 ◽  
Vol 23 (56) ◽  
pp. 1-144 ◽  
Author(s):  
Ian St James-Roberts ◽  
Rosemary Garratt ◽  
Charlotte Powell ◽  
Deborah Bamber ◽  
Jaqui Long ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Well Being ◽  
Health Technology ◽  
Adverse Outcomes ◽  
Control Group ◽  
Support Materials ◽  
Infant Crying ◽  
Stage 1 ◽  
The Impact

Background Around 20% of 1- to 4-month-old infants cry for long periods without an apparent reason. Traditionally, this was attributed to gastrointestinal disorder (‘colic’), but evidence shows that just 5% of infants cry a lot because of organic disturbances; in most cases, the crying is attributable to normal developmental processes. This has led to a focus on the impact of the crying on parents. Parental vulnerabilities influence how parents evaluate and respond to the crying and predict adverse outcomes. By developing evidence-based services that support parents, this study was designed to take the first steps towards national health services that enhance the coping and well-being of parents whose babies excessively cry. Related aims were to improve these infants’ outcomes and how NHS money is spent. Objectives To develop a novel intervention package to support parents of excessively crying infants and to examine the feasibility of delivering and evaluating it in the NHS. Design Stage 1 of this study aimed to (1) complete a literature review to identify example support materials, (2) obtain parents’ guidance on the support needed when a baby cries excessively, together with their evaluation of the example materials, and (3) develop a support package based on the results. Stage 2 aimed to (1) recruit 60 parents whose babies were currently excessively crying, (2) assess parents’ and NHS professionals’ willingness to complete a study of the support package, (3) measure the use and evaluation of the package components, (4) estimate the package component costs and (5) provide evidence on the feasibility and methods for a large-scale trial. Setting Primary health care. Participants Stage 1: 20 parents of previously excessively crying infants and 55 health visitors (HVs) or specialist community public health nurses (SCPHNs). Stage 2: 57 parents of currently excessively crying infants and 124 HVs/SCPHNs. Interventions The support package included a website, a printed booklet and a programme of cognitive–behavioural therapy-based sessions delivered to parents by a qualified practitioner. Main outcome measures (1) Demographic data, (2) figures for parents’ use of the package components and continuation in the study, (3) parents’ and HVs’/SCPHNs’ ratings of the package components and suitability for NHS use, (4) questionnaire measures of parental well-being and infant health and (5) costs. Results Most parents (95%) accessed the website or printed materials and half (51%) attended the practitioner sessions. All 52 parents and 85% of HVs/SCPHNs providing data would support the inclusion of the package in the NHS. It was associated with reduced parental frustration, anxiety, depression, reported infant crying and contacts with health professionals and increased knowledge about crying. Methods for a full trial and figures for the cost of excessive infant crying for the NHS and each package element were identified. Limitations No control group was included. Most of the recruited parents were white, well educated and in stable relationships. Conclusions Parents and HVs/SCPHNs recognise the need for NHS provisions that support parents of excessively crying babies and consider the materials developed to meet that need. A full-scale randomised controlled trial is feasible and desirable. Trial registration Current Controlled Trials ISRCTN84975637. 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. 23, No. 56. See the NIHR Journals Library website for further project information.

scholarly journals Partial ablation versus radical prostatectomy in intermediate-risk prostate cancer: the PART feasibility RCT

2018 ◽  
Vol 22 (52) ◽  
pp. 1-96 ◽  
Author(s):  
Freddie C Hamdy ◽  
Daisy Elliott ◽  
Steffi le Conte ◽  
Lucy C Davies ◽  
Richéal M Burns ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Radical Prostatectomy ◽  
Health Technology Assessment ◽  
Outcome Measures ◽  
Feasibility Study ◽  
Technology Assessment ◽  
Health Technology ◽  
Data Capture ◽  
Secondary Outcome ◽  
Intermediate Risk

Background Prostate cancer (PCa) is the most common cancer in men in the UK. Patients with intermediate-risk, clinically localised disease are offered radical treatments such as surgery or radiotherapy, which can result in severe side effects. A number of alternative partial ablation (PA) technologies that may reduce treatment burden are available; however the comparative effectiveness of these techniques has never been evaluated in a randomised controlled trial (RCT). Objectives To assess the feasibility of a RCT of PA using high-intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) for intermediate-risk PCa and to test and optimise methods of data capture. Design We carried out a prospective, multicentre, open-label feasibility study to inform the design and conduct of a future RCT, involving a QuinteT Recruitment Intervention (QRI) to understand barriers to participation. Setting Five NHS hospitals in England. Participants Men with unilateral, intermediate-risk, clinically localised PCa. Interventions Radical prostatectomy compared with HIFU. Primary outcome measure The randomisation of 80 men. Secondary outcome measures Findings of the QRI and assessment of data capture methods. Results Eighty-seven patients consented to participate by 31 March 2017 and 82 men were randomised by 4 May 2017 (41 men to the RP arm and 41 to the HIFU arm). The QRI was conducted in two iterative phases: phase I identified a number of barriers to recruitment, including organisational challenges, lack of recruiter equipoise and difficulties communicating with patients about the study, and phase II comprised the development and delivery of tailored strategies to optimise recruitment, including group training, individual feedback and ‘tips’ documents. At the time of data extraction, on 10 October 2017, treatment data were available for 71 patients. Patient characteristics were similar at baseline and the rate of return of all clinical case report forms (CRFs) was 95%; the return rate of the patient-reported outcome measures (PROMs) questionnaire pack was 90.5%. Centres with specific long-standing expertise in offering HIFU as a routine NHS treatment option had lower recruitment rates (Basingstoke and Southampton) – with University College Hospital failing to enrol any participants – than centres offering HIFU in the trial context only. Conclusions Randomisation of men to a RCT comparing PA with radical treatments of the prostate is feasible. The QRI provided insights into the complexities of recruiting to this surgical trial and has highlighted a number of key lessons that are likely to be important if the study progresses to a main trial. A full RCT comparing clinical effectiveness, cost-effectiveness and quality-of-life outcomes between radical treatments and PA is now warranted. Future work Men recruited to the feasibility study will be followed up for 36 months in accordance with the protocol. We will design a full RCT, taking into account the lessons learnt from this study. CRFs will be streamlined, and the length and frequency of PROMs and resource use diaries will be reviewed to reduce the burden on patients and research nurses and to optimise data completeness. Trial registration Current Controlled Trials ISRCTN99760303. 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. 22, No. 52. See the NIHR Journals Library website for further project information.

Versorgungsforschung in der Klinischen Neuropsychologie – eine Standortbestimmung

2008 ◽  
Vol 19 (4) ◽  
pp. 253-269 ◽  
Author(s):  
Sabine Heel ◽  
Sonja Fischer ◽  
Stefan Fischer ◽  
Tobias Grässer ◽  
Ellen Hämmerling ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Empirische Forschung

Zunächst führt dieser Artikel in die wesentlichen Begrifflichkeiten und Zielstellungen der Versorgungsforschung ein. Er befasst sich dann mit der Frage, wie die einzelnen Teildisziplinen der Versorgungsforschung, (1) die Bedarfsforschung, (2) die Inanspruchnahmeforschung, (3) die Organisationsforschung, (4) das Health Technology Assessment, (5) die Versorgungsökonomie, (6) die Qualitätsforschung und zuletzt (7) die Versorgungsepidemiologie konzeptionell zu fassen sind, und wie sie für neuropsychologische Anliegen ausformuliert werden müssen. In diesem Zusammenhang werden die in den einzelnen Bereichen jeweils vorliegenden versorgungsrelevanten Studienergebnisse referiert. Soweit es zulässig ist, werden Bedarfe für die Versorgungsforschung und Versorgungspraxis in der Neurorehabilitation daraus abgeleitet und Anregungen für die weitere empirische Forschung formuliert. Der Artikel bezieht sich – entsprechend seines Anliegens – ausschließlich auf Studien, die sich mit der Situation der deutschen Neurorehabilitation befassen.

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