scholarly journals Sexual risk reduction interventions for patients attending sexual health clinics: a mixed-methods feasibility study

2019 ◽  
Vol 23 (12) ◽  
pp. 1-122 ◽  
Author(s):  
Carina King ◽  
Carrie Llewellyn ◽  
Maryam Shahmanesh ◽  
Charles Abraham ◽  
Julia Bailey ◽  
...  
Keyword(s):  
Systematic Review ◽  
Mixed Methods ◽  
Sexual Risk ◽  
Technology Assessment ◽  
Health Technology ◽  
Intervention Package ◽  
Sexual Risk Reduction ◽  
Digital Interventions ◽  
One To One

Background Sexually transmitted infections (STIs) continue to represent a major public health challenge. There is evidence that behavioural interventions to reduce risky sexual behaviours can reduce STI rates in patients attending sexual health (SH) services. However, it is not known if these interventions are effective when implemented at scale in SH settings in England. Objectives The study (Santé) had two main objectives – (1) to develop and pilot a package of evidence-based sexual risk reduction interventions that can be delivered through SH services and (2) to assess the feasibility of conducting a randomised controlled trial (RCT) to determine effectiveness against usual care. Design The project was a multistage, mixed-methods study, with developmental and pilot RCT phases. Preparatory work included a systematic review, an analysis of national surveillance data, the development of a triage algorithm, and interviews and surveys with SH staff and patients to identify, select and adapt interventions. A pilot cluster RCT was planned for eight SH clinics; the intervention would be offered in four clinics, with qualitative and process evaluation to assess feasibility and acceptability. Four clinics acted as controls; in all clinics, participants would be consented to a 6-week follow-up STI screen. Setting SH clinics in England. Participants Young people (aged 16–25 years), and men who have sex with men. Intervention A three-part intervention package – (1) a triage tool to score patients as being at high or low risk of STI using routine data, (2) a study-designed web page with tailored SH information for all patients, regardless of risk and (3) a brief one-to-one session based on motivational interviewing for high-risk patients. Main outcome measures The three outcomes were (1) the acceptability of the intervention to patients and SH providers, (2) the feasibility of delivering the interventions within existing resources and (3) the feasibility of obtaining follow-up data on STI diagnoses (primary outcome in a full trial). Results We identified 33 relevant trials from the systematic review, including videos, peer support, digital and brief one-to-one sessions. Patients and SH providers showed preferences for one-to-one and digital interventions, and providers indicated that these intervention types could feasibly be implemented in their settings. There were no appropriate digital interventions that could be adapted in time for the pilot; therefore, we created a placeholder for the purposes of the pilot. The intervention package was piloted in two SH settings, rather than the planned four. Several barriers were found to intervention implementation, including a lack of trained staff time and clinic space. The intervention package was theoretically acceptable, but we observed poor engagement. We recruited patients from six clinics for the follow-up, rather than eight. The completion rate for follow-up was lower than anticipated (16% vs. 46%). Limitations Fewer clinics were included in the pilot than planned, limiting the ability to make strong conclusions on the feasibility of the RCT. Conclusion We were unable to conclude whether or not a definitive RCT would be feasible because of challenges in implementation of a pilot, but have laid the groundwork for future research in the area. Trial registration Current Controlled Trials ISRCTN16738765. 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. 12. See the NIHR Journals Library website for further project information.

scholarly journals Pressure garment to prevent abnormal scarring after burn injury in adults and children: the PEGASUS feasibility RCT and mixed-methods study

2018 ◽  
Vol 22 (36) ◽  
pp. 1-162 ◽  
Author(s):  
Naiem Moiemen ◽  
Jonathan Mathers ◽  
Laura Jones ◽  
Jonathan Bishop ◽  
Philip Kinghorn ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Standard Care ◽  
Pilot Trial ◽  
Health Technology ◽  
Burn Scar ◽  
Individual Interviews ◽  
Scar Management

Background Eleven million people suffer a fire-related injury worldwide every year, and 71% have significant scarring. Pressure garment therapy (PGT) is a standard part of burn scar management, but there is little evidence of its clinical effectiveness or cost-effectiveness. Objective To identify the barriers to, and the facilitators of, conducting a randomised controlled trial (RCT) of burn scar management with and without PGT and test whether or not such a trial is feasible. Design Web-based surveys, semistructured individual interviews, a pilot RCT including a health economic evaluation and embedded process evaluation. Setting UK NHS burns services. Interviews and the pilot trial were run in seven burns services. Participants Thirty NHS burns services and 245 staff provided survey responses and 15 staff participated in individual interviews. Face-to-face interviews were held with 24 adult patients and 16 parents of paediatric patients who had undergone PGT. The pilot trial recruited 88 participants (57 adults and 31 children) who were at risk of hypertrophic scarring and were considered suitable for scar management therapy. Interviews were held with 34 participants soon after recruitment, with 23 participants at 12 months and with eight staff from six sites at the end of the trial. Interventions The intervention was standard care with pressure garments. The control was standard care comprising scar management techniques involving demonstration and recommendations to undertake massage three or four times per day with moisturiser, silicone treatment, stretching and other exercises. Main outcome measures Feasibility was assessed by eligibility rates, consent rates, retention in allocated arms, adherence with treatment and follow-up and completion of outcome assessments. The outcomes from interview-based studies were core outcome domains and barriers to, and facilitators of, trial participation and delivery. Results NHS burns services treat 2845 patients per annum (1476 paediatric and 1369 adult) and use pressure garments for 6–18 months, costing £2,171,184. The majority of staff perceived a need for a RCT of PGT, but often lacked equipoise around the research question and PGT as a treatment. Strong views about the use of PGT have the potential to influence the conduct of a full-scale RCT. A range of outcome domains was identified as important via the qualitative research: perceptions of appearance, specific scar characteristics, function, pain and itch, broader psychosocial outcomes and treatment burden. The outcome tools evaluated in the pilot trial did not cover all of these domains. The planned 88 participants were recruited: the eligibility rate was 88% [95% confidence interval (CI) 83% to 92%], the consent rate was 47% (95% CI 40% to 55%). Five (6%) participants withdrew, 14 (16%) were lost to follow-up and 8 (9%) crossed over. Adherence was as in clinical practice. Completion of outcomes was high for adult patients but poorer from parents of paediatric patients, particularly for quality of life. Sections on range of movement and willingness to pay were found to be challenging and poorly completed. Limitations The Brisbane Burn Scar Impact Profile appears more suitable in terms of conceptual coverage than the outcome scales that were used in the trial but was not available at the time of the study. Conclusions A definitive RCT of PGT in burn scar management appears feasible. However, staff attitudes to the use of pressure garments may lead to biases, and the provision of training and support to sites and an ongoing assessment of trial processes are required. Future work We recommend that any future trial include an in-depth mixed-methods recruitment investigation and a process evaluation to account for this. Trial registration Current Controlled Trials ISRCTN34483199. 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. 36. See the NIHR Journals Library website for further project information

ETHICS IN HEALTH TECHNOLOGY ASSESSMENT: A SYSTEMATIC REVIEW

2018 ◽  
Vol 34 (5) ◽  
pp. 447-457 ◽  
Author(s):  
Christian A. Bellemare ◽  
Pierre Dagenais ◽  
Suzanne K.-Bédard ◽  
Jean-Pierre Béland ◽  
Louise Bernier ◽  
...  
Keyword(s):  
Systematic Review ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Policy Decision ◽  
Health Technology ◽  
Ethical Analysis ◽  
Social Needs ◽  
Inductive Method ◽  
Value Judgments ◽  
Ethical Evaluation

Objectives:Integration of ethics into health technology assessment (HTA) remains challenging for HTA practitioners. We conducted a systematic review on social and methodological issues related to ethical analysis in HTA. We examined: (1) reasons for integrating ethics (social needs); (2) obstacles to ethical integration; (3) concepts and processes deployed in ethical evaluation (more specifically value judgments) and critical analyses of formal experimentations of ethical evaluation in HTA.Methods:Search criteria included “ethic,” “technology assessment,” and “HTA”. The literature search was done in Medline/Ovid, SCOPUS, CINAHL, PsycINFO, and the international HTA Database. Screening of citations, full-text screening, and data extraction were performed by two subgroups of two independent reviewers. Data extracted from articles were grouped into categories using a general inductive method.Results:A list of 1,646 citations remained after the removal of duplicates. Of these, 132 were fully reviewed, yielding 67 eligible articles for analysis. The social need most often reported was to inform policy decision making. The absence of shared standard models for ethical analysis was the obstacle to integration most often mentioned. Fairness and Equity and values embedded in Principlism were the values most often mentioned in relation to ethical evaluation.Conclusions:Compared with the scientific experimental paradigm, there are no settled proceedings for ethics in HTA nor consensus on the role of ethical theory and ethical expertise hindering its integration. Our findings enable us to hypothesize that there exists interdependence between the three issues studied in this work and that value judgments could be their linking concept.

scholarly journals Prophylactic levofloxacin to prevent infections in newly diagnosed symptomatic myeloma: the TEAMM RCT

2019 ◽  
Vol 23 (62) ◽  
pp. 1-94 ◽  
Author(s):  
Mark T Drayson ◽  
Stella Bowcock ◽  
Tim Planche ◽  
Gulnaz Iqbal ◽  
Guy Pratt ◽  
...  
Keyword(s):  
Overall Survival ◽  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Newly Diagnosed ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Febrile Episodes

Background Myeloma causes profound immunodeficiency and recurrent serious infections. There are approximately 5500 new UK cases of myeloma per annum, and one-quarter of patients will have a serious infection within 3 months of diagnosis. Newly diagnosed patients may benefit from antibiotic prophylaxis to prevent infection. However, the use of prophylaxis has not been established in myeloma and may be associated with health-care-associated infections (HCAIs), such as Clostridium difficile. There is a need to assess the benefits and cost-effectiveness of the use of antibacterial prophylaxis against any risks in a double-blind, placebo-controlled, randomised clinical trial. Objectives To assess the risks, benefits and cost-effectiveness of prophylactic levofloxacin in newly diagnosed symptomatic myeloma patients. Design Multicentre, randomised, double-blind, placebo-controlled trial. A central telephone randomisation service used a minimisation computer algorithm to allocate treatments in a 1 : 1 ratio. Setting A total of 93 NHS hospitals throughout England, Northern Ireland and Wales. Participants A total of 977 patients with newly diagnosed symptomatic myeloma. Intervention Patients were randomised to receive levofloxacin or placebo tablets for 12 weeks at the start of antimyeloma treatment. Treatment allocation was blinded and balanced by centre, estimated glomerular filtration rate and intention to give high-dose chemotherapy with autologous stem cell transplantation. Follow-up was at 4-week intervals up to 16 weeks, with a further follow-up at 1 year. Main outcome measures The primary outcome was to assess the number of febrile episodes (or deaths) in the first 12 weeks from randomisation. Secondary outcomes included number of deaths and infection-related deaths, days in hospital, carriage and invasive infections, response to antimyeloma treatment and its relation to infection, quality of life and overall survival within the first 12 weeks and beyond. Results In total, 977 patients were randomised (levofloxacin, n = 489; placebo, n = 488). A total of 134 (27%) events (febrile episodes, n = 119; deaths, n = 15) occurred in the placebo arm and 95 (19%) events (febrile episodes, n = 91; deaths, n = 4) occurred in the levofloxacin arm; the hazard ratio for time to first event (febrile episode or death) within the first 12 weeks was 0.66 (95% confidence interval 0.51 to 0.86; p = 0.002). Levofloxacin also reduced other infections (144 infections from 116 patients) compared with placebo (179 infections from 133 patients; p-trend of 0.06). There was no difference in new acquisitions of C. difficile, methicillin-resistant Staphylococcus aureus and extended-spectrum beta-lactamase Gram-negative organisms when assessed up to 16 weeks. Levofloxacin produced slightly higher quality-adjusted life-year gains over 16 weeks, but had associated higher costs for health resource use. With a median follow-up of 52 weeks, there was no significant difference in overall survival (p = 0.94). Limitations Short duration of prophylactic antibiotics and cost-effectiveness. Conclusions During the 12 weeks from new diagnosis, the addition of prophylactic levofloxacin to active myeloma treatment significantly reduced febrile episodes and deaths without increasing HCAIs or carriage. Future work should aim to establish the optimal duration of antibiotic prophylaxis and should involve the laboratory investigation of immunity, inflammation and disease activity on stored samples funded by the TEAMM (Tackling Early Morbidity and Mortality in Myeloma) National Institute for Health Research Efficacy and Mechanism Evaluation grant (reference number 14/24/04). Trial registration Current Controlled Trials ISRCTN51731976. Funding details This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 62. See the NIHR Journals Library website for further project information.

scholarly journals Effectiveness of Digital Interventions for Reducing Behavioral Risks of Cardiovascular Disease in Nonclinical Adult Populations: Systematic Review of Reviews

10.2196/19688 ◽  
2021 ◽  
Vol 23 (5) ◽  
pp. e19688
Author(s):  
Natalie Gold ◽  
Amy Yau ◽  
Benjamin Rigby ◽  
Chris Dyke ◽  
Elizabeth Alice Remfry ◽  
...  
Keyword(s):  
Physical Activity ◽  
Systematic Review ◽  
Alcohol Consumption ◽  
Meta Analysis ◽  
Face To Face ◽  
Positive Effects ◽  
Digital Interventions ◽  
Diet And Physical Activity ◽  
Intent To Treat

Background Digital health interventions are increasingly being used as a supplement or replacement for face-to-face services as a part of predictive prevention. They may be offered to those who are at high risk of cardiovascular disease and need to improve their diet, increase physical activity, stop smoking, or reduce alcohol consumption. Despite the popularity of these interventions, there is no overall summary and comparison of the effectiveness of different modes of delivery of a digital intervention to inform policy. Objective This review aims to summarize the effectiveness of digital interventions in improving behavioral and health outcomes related to physical activity, smoking, alcohol consumption, or diet in nonclinical adult populations and to identify the effectiveness of different modes of delivery of digital interventions. Methods We reviewed articles published in the English language between January 1, 2009, and February 25, 2019, that presented a systematic review with a narrative synthesis or meta-analysis of any study design examining digital intervention effectiveness; data related to adults (≥18 years) in high-income countries; and data on behavioral or health outcomes related to diet, physical activity, smoking, or alcohol, alone or in any combination. Any time frame or comparator was considered eligible. We searched MEDLINE, Embase, PsycINFO, Cochrane Reviews, and gray literature. The AMSTAR-2 tool was used to assess review confidence ratings. Results We found 92 reviews from the academic literature (47 with meta-analyses) and 2 gray literature items (1 with a meta-analysis). Digital interventions were typically more effective than no intervention, but the effect sizes were small. Evidence on the effectiveness of digital interventions compared with face-to-face interventions was mixed. Most trials reported that intent-to-treat analysis and attrition rates were often high. Studies with long follow-up periods were scarce. However, we found that digital interventions may be effective for up to 6 months after the end of the intervention but that the effects dissipated by 12 months. There were small positive effects of digital interventions on smoking cessation and alcohol reduction; possible effectiveness in combined diet and physical activity interventions; no effectiveness for interventions targeting physical activity alone, except for when interventions were delivered by mobile phone, which had medium-sized effects; and no effectiveness observed for interventions targeting diet alone. Mobile interventions were particularly effective. Internet-based interventions were generally effective. Conclusions Digital interventions have small positive effects on smoking, alcohol consumption, and in interventions that target a combination of diet and physical activity. Small effects may have been due to the low efficacy of treatment or due to nonadherence. In addition, our ability to make inferences from the literature we reviewed was limited as those interventions were heterogeneous, many reviews had critically low AMSTAR-2 ratings, analysis was typically intent-to-treat, and follow-up times were relatively short. Trial Registration PROSPERO International Prospective Register of Systematic Reviews CRD42019126074; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=126074.

scholarly journals Microenterprise Development Interventions for Sexual Risk Reduction: A Systematic Review

2013 ◽  
Vol 17 (9) ◽  
pp. 2864-2877 ◽  
Author(s):  
Rosa R. Cui ◽  
Ramon Lee ◽  
Harsha Thirumurthy ◽  
Kathryn E. Muessig ◽  
Joseph D. Tucker
Keyword(s):  
Systematic Review ◽  
Risk Reduction ◽  
Sexual Risk ◽  
Sexual Risk Reduction ◽  
Microenterprise Development ◽  
Development Interventions

scholarly journals Application of Health Technology Assessment (HTA) to Evaluate New Laboratory Tests in a Health System: A Case Study of Bladder Cancer Testing

2020 ◽  
Vol 7 ◽  
pp. 237428952096822
Author(s):  
Erik J. Landaas ◽  
Ashley M. Eckel ◽  
Jonathan L. Wright ◽  
Geoffrey S. Baird ◽  
Ryan N. Hansen ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Pilot Study ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Health Technology ◽  
Test System ◽  
Real World Data ◽  
World Data

We describe the methods and decision from a health technology assessment of a new molecular test for bladder cancer (Cxbladder), which was proposed for adoption to our send-out test menu by urology providers. The Cxbladder health technology assessment report contained mixed evidence; predominant concerns were related to the test’s low specificity and high cost. The low specificity indicated a high false-positive rate, which our laboratory formulary committee concluded would result in unnecessary confirmatory testing and follow-up. Our committee voted unanimously to not adopt the test system-wide for use for the initial diagnosis of bladder cancer but supported a pilot study for bladder cancer recurrence surveillance. The pilot study used real-world data from patient management in the scenario in which a patient is evaluated for possible recurrent bladder cancer after a finding of atypical cytopathology in the urine. We evaluated the type and number of follow-up tests conducted including urine cytopathology, imaging studies, repeat cystoscopy evaluation, biopsy, and repeat Cxbladder and their test results. The pilot identified ordering challenges and suggested potential use cases in which the results of Cxbladder affected a change in management. Our health technology assessment provided an objective process to efficiently review test performance and guide new test adoption. Based on our pilot, there were real-world data indicating improved clinician decision-making among select patients who underwent Cxbladder testing.

Pharmacological treatment of oro-facial pain - health technology assessment including a systematic review with network meta-analysis

2017 ◽  
Vol 44 (10) ◽  
pp. 800-826 ◽  
Author(s):  
B. Häggman-Henrikson ◽  
P. Alstergren ◽  
T. Davidson ◽  
E. D. Högestätt ◽  
P. Östlund ◽  
...  
Keyword(s):  
Systematic Review ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Pharmacological Treatment ◽  
Facial Pain ◽  
Meta Analysis ◽  
Health Technology

scholarly journals Alcohol and Sexual Risk Reduction Interventions Among People Living in Russia: A Systematic Review and Meta-analysis

2013 ◽  
Vol 18 (10) ◽  
pp. 1835-1846 ◽  
Author(s):  
Chiao-Wen Lan ◽  
Lori A. J. Scott-Sheldon ◽  
Kate B. Carey ◽  
Blair T. Johnson ◽  
Michael P. Carey
Keyword(s):  
Systematic Review ◽  
Risk Reduction ◽  
Sexual Risk ◽  
Meta Analysis ◽  
Sexual Risk Reduction
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