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

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.

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An Occupational Therapy intervention for residents with stroke-related disabilities in UK Care Homes (OTCH): cluster randomised controlled trial with economic evaluation

Health Technology Assessment ◽

10.3310/hta20150 ◽

2016 ◽

Vol 20 (15) ◽

pp. 1-138 ◽

Cited By ~ 4

Author(s):

Catherine M Sackley ◽

Marion F Walker ◽

Christopher R Burton ◽

Caroline L Watkins ◽

Jonathan Mant ◽

...

Keyword(s):

Economic Evaluation ◽

Occupational Therapy ◽

Health Technology Assessment ◽

Technology Assessment ◽

Functional Activity ◽

Primary Outcome ◽

Controlled Trial ◽

Care Home ◽

Health Technology ◽

Care Homes

BackgroundCare home residents with stroke-related disabilities have significant activity limitations. Phase II trial results suggested a potential benefit of occupational therapy (OT) in maintaining residents’ capacity to engage in functional activity.ObjectiveTo evaluate the clinical effectiveness and cost-effectiveness of a targeted course of OT in maintaining functional activity and reducing further health risks from inactivity for UK care home residents living with stroke-related disabilities.DesignPragmatic, parallel-group, cluster randomised controlled trial with economic evaluation. Cluster randomisation occurred at the care-home level. Homes were stratified according to trial administrative centre and type of care provided (nursing or residential), and they were randomised 1 : 1 to either the intervention or the control arm.SettingThe setting was 228 care homes which were local to 11 trial administrative centres across England and Wales.ParticipantsCare home residents with a history of stroke or transient ischaemic attack, including residents with communication and cognitive impairments, not receiving end-of-life care.InterventionPersonalised 3-month course of OT delivered by qualified therapists. Care workers participated in training workshops to support personal activities of daily living. The control condition consisted of usual care for residents.Main outcome measuresOutcome data were collected by a blinded assessor. The primary outcome at the participant level was the Barthel Index of Activities of Daily Living (BI) score at 3 months. The secondary outcomes included BI scores at 6 and 12 months post randomisation, and the Rivermead Mobility Index, Geriatric Depression Scale-15 and European Quality of Life-5 Dimensions, three levels, questionnaire scores at all time points. Economic evaluation examined the incremental cost per quality-adjusted life-year (QALY) gain. Costs were estimated from the perspective of the NHS and Personal Social Services.ResultsOverall, 568 residents from 114 care homes were allocated to the intervention arm and 474 residents from another 114 care homes were allocated to the control arm, giving a total of 1042 participants. Randomisation occurred between May 2010 and March 2012. The mean age of participants was 82.9 years, and 665 (64%) were female. No adverse events attributable to the intervention were recorded. Of the 1042 participants, 870 (83%) were included in the analysis of the primary outcome (intervention,n = 479; control,n = 391). The primary outcome showed no significant differences between groups. The adjusted mean difference in the BI score between groups was 0.19 points higher in the intervention arm [95% confidence interval (CI) –0.33 to 0.70,p = 0.48; adjusted intracluster correlation coefficient 0.09]. Secondary outcome measures showed no significant differences at all time points. Mean incremental cost of the Occupational Therapy intervention for residents with stroke living in UK Care Homes intervention was £438.78 (95% CI –£3360.89 to £1238.46) and the incremental QALY gain was 0.009 (95% CI –0.030 to 0.048).LimitationsA large proportion of participants with very severe activity-based limitations and cognitive impairment may have limited capacity to engage in therapy.ConclusionA 3-month individualised course of OT showed no benefit in maintaining functional activity in an older care home population with stroke-related disabilities.Future workThere is an urgent need to reduce health-related complications caused by inactivity and to provide an enabling built environment within care homes.Trial registrationCurrent Controlled Trials ISRCTN00757750.FundingThis project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 15. See the Health Technology Assessment programme website for further project information.

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Intratumoural immune signature to identify patients with primary colorectal cancer who do not require follow-up after resection: an observational study

Health Technology Assessment ◽

10.3310/hta25020 ◽

2021 ◽

Vol 25 (2) ◽

pp. 1-32

Author(s):

John N Primrose ◽

Siân A Pugh ◽

Gareth Thomas ◽

Matthew Ellis ◽

Karwan Moutasim ◽

...

Keyword(s):

Colorectal Cancer ◽

Observational Study ◽

Health Technology Assessment ◽

Technology Assessment ◽

Tissue Microarrays ◽

Health Technology ◽

Cell Counting ◽

Primary Colorectal Cancer ◽

Immune Signature

Background Following surgical and adjuvant treatment of primary colorectal cancer, many patients are routinely followed up with axial imaging (most commonly computerised tomography imaging) and blood carcinoembryonic antigen (a tumour marker) testing. Because fewer than one-fifth of patients will relapse, a large number of patients are followed up unnecessarily. Objectives To determine whether or not the intratumoural immune signature could identify a cohort of patients with a relapse rate so low that follow-up is unnecessary. Design An observational study based on a secondary tissue collection of the tumours from participants in the FACS (Follow-up After Colorectal Cancer Surgery) trial. Setting and participants Formalin-fixed paraffin-embedded tumour tissue was obtained from 550 out of 1202 participants in the FACS trial. Tissue microarrays were constructed and stained for cluster of differentiation (CD)3+ and CD45RO+ T lymphocytes as well as standard haematoxylin and eosin staining, with a view to manual and, subsequently, automated cell counting. Results The tissue microarrays were satisfactorily stained for the two immune markers. Manual cell counting proved possible on the arrays, but manually counting the number of cores for the entire study was found to not be feasible; therefore, an attempt was made to use automatic cell counting. Although it is clear that this approach is workable, there were both hardware and software problems; therefore, reliable data could not be obtained within the time frame of the study. Limitations The main limitations were the inability to use machine counting because of problems with both hardware and software, and the loss of critical scientific staff. Findings from this research indicate that this approach will be able to count intratumoural immune cells in the long term, but whether or not the original aim of the project proved possible is not known. Conclusions The project was not successful in its aim because of the failure to achieve a reliable counting system. Future work Further work is needed to perfect immune cell machine counting and then complete the objectives of this study that are still relevant. Trial registration Current Controlled Trials ISRCTN41458548. 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. 2. See the NIHR Journals Library website for further project information.

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

Health Technology Assessment ◽

10.3310/hta21810 ◽

2017 ◽

Vol 21 (81) ◽

pp. 1-68 ◽

Cited By ~ 3

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.

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

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462315000185 ◽

2015 ◽

Vol 31 (3) ◽

pp. 154-165 ◽

Cited By ~ 25

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.

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

Health Technology Assessment ◽

10.3310/hta23560 ◽

2019 ◽

Vol 23 (56) ◽

pp. 1-144 ◽

Cited By ~ 2

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.

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Versorgungsforschung in der Klinischen Neuropsychologie – eine Standortbestimmung

Zeitschrift für Neuropsychologie ◽

10.1024/1016-264x.19.4.253 ◽

2008 ◽

Vol 19 (4) ◽

pp. 253-269 ◽

Cited By ~ 3

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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