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Clinical Trials (London, England) Aug 2022There are increasing pressures for anonymised datasets from clinical trials to be shared across the scientific community, and differing recommendations exist on how to...
BACKGROUND/AIMS
There are increasing pressures for anonymised datasets from clinical trials to be shared across the scientific community, and differing recommendations exist on how to perform anonymisation prior to sharing. We aimed to systematically identify, describe and synthesise existing recommendations for anonymising clinical trial datasets to prepare for data sharing.
METHODS
We systematically searched MEDLINE, EMBASE and Web of Science from inception to 8 February 2021. We also searched other resources to ensure the comprehensiveness of our search. Any publication reporting recommendations on anonymisation to enable data sharing from clinical trials was included. Two reviewers independently screened titles, abstracts and full text for eligibility. One reviewer extracted data from included papers using thematic synthesis, which then was sense-checked by a second reviewer. Results were summarised by narrative analysis.
RESULTS
Fifty-nine articles (from 43 studies) were eligible for inclusion. Three distinct themes are emerging: anonymisation, de-identification and pseudonymisation. The most commonly used anonymisation techniques are: removal of direct patient identifiers; and careful evaluation and modification of indirect identifiers to minimise the risk of identification. Anonymised datasets joined with controlled access was the preferred method for data sharing.
CONCLUSIONS
There is no single standardised set of recommendations on how to anonymise clinical trial datasets for sharing. However, this systematic review shows a developing consensus on techniques used to achieve anonymisation. Researchers in clinical trials still consider that anonymisation techniques by themselves are insufficient to protect patient privacy, and they need to be paired with controlled access.
Topics: Confidentiality; Data Anonymization; Humans; Information Dissemination; Research Personnel
PubMed: 35730910
DOI: 10.1177/17407745221087469 -
BMJ Open Oct 2022To identify the evidence gaps that exist regarding the efficacy or effectiveness of hand surgery.
OBJECTIVES
To identify the evidence gaps that exist regarding the efficacy or effectiveness of hand surgery.
SETTING
A scoping review. We systematically searched MEDLINE, Embase and CENTRAL databases to identify all hand surgical randomised controlled trials from inception to 7 November 2020.
RESULTS
Of the 220 identified randomised controlled trials, none were fundamental efficacy trials, that is, compared surgery with placebo surgery. 172 (78%) trials compared the outcomes of different surgical techniques, and 143 (65%) trials were trauma related. We identified only 47 (21%) trials comparing surgery with non-operative care or injection.
CONCLUSION
The evidence supporting use of surgery especially for chronic hand conditions is scarce. To determine optimal care for people with hand conditions, more resources should be aimed at placebo-controlled trials and pragmatic effectiveness trials comparing hand surgery with non-operative care.
PROSPERO REGISTRATION NUMBER
CRD42019122710.
Topics: Hand; Humans; Randomized Controlled Trials as Topic
PubMed: 36216426
DOI: 10.1136/bmjopen-2022-062773 -
Implementation Science Communications Nov 2023Improving access to high-quality healthcare for individuals in correctional settings is critical to advancing health equity in the United States. Compared to the general... (Review)
Review
BACKGROUND
Improving access to high-quality healthcare for individuals in correctional settings is critical to advancing health equity in the United States. Compared to the general population, criminal-legal involved individuals experience higher rates of chronic health conditions and poorer health outcomes. Implementation science frameworks and strategies offer useful tools to integrate health interventions into criminal-legal settings and to improve care. A review of implementation science in criminal-legal settings to date is necessary to advance future applications. This systematic review summarizes research that has harnessed implementation science to promote the uptake of effective health interventions in adult criminal-legal settings.
METHODS
A systematic review of seven databases (Academic Search Premier, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Social Work Abstracts, ProQuest Criminal Justice Database, ProQuest Sociological Abstracts, MEDLINE/PubMed) was conducted. Eligible studies used an implementation science framework to assess implementation outcomes, determinants, and/or implementation strategies in adult criminal-legal settings. Qualitative synthesis was used to extract and summarize settings, study designs, sample characteristics, methods, and application of implementation science methods. Implementation strategies were further analyzed using the Pragmatic Implementation Reporting Tool.
RESULTS
Twenty-four studies met inclusion criteria. Studies implemented interventions to address infectious diseases (n=9), substance use (n=6), mental health (n=5), co-occurring substance use and mental health (n=2), or other health conditions (n=2). Studies varied in their operationalization and description of guiding implementation frameworks/taxonomies. Sixteen studies reported implementation determinants and 12 studies measured implementation outcomes, with acceptability (n=5), feasibility (n=3), and reach (n=2) commonly assessed. Six studies tested implementation strategies. Systematic review results were used to generate recommendations for improving implementation success in criminal-legal contexts.
CONCLUSIONS
The focus on implementation determinants in correctional health studies reflects the need to tailor implementation efforts to complex organizational and inter-agency contexts. Future studies should investigate policy factors that influence implementation success, design, and test implementation strategies tailored to determinants, and investigate a wider array of implementation outcomes relevant to criminal-legal settings, health interventions relevant to adult and juvenile populations, and health equity outcomes.
TRIAL REGISTRATION
A study protocol (CRD42020114111) was registered with Prospero.
PubMed: 38001546
DOI: 10.1186/s43058-023-00521-4 -
European Urology Open Science Sep 2021White light (WL) cystoscopy and transurethral resection of bladder tumour (TURBT) comprise the current gold standard technique for detecting and grading bladder cancer.... (Review)
Review
CONTEXT
White light (WL) cystoscopy and transurethral resection of bladder tumour (TURBT) comprise the current gold standard technique for detecting and grading bladder cancer. However, with WL cystoscopy, recurrence following initial TURBT is high, and identification of smaller tumours and carcinoma in situ is poor. Photodynamic diagnosis (PDD) has been developed to improve the detection of bladder.
OBJECTIVE
To assess the effect of PDD-guided TURBT compared with WL on recurrence rates (RRs) in non-muscle-invasive bladder cancer (NMIBC).
EVIDENCE ACQUISITION
A systematic review of the literature from inception to April 2020 using Medline, EMBASE, and CENTRAL was undertaken. Randomised control trials comparing TURBT undertaken with PDD to WL that reported RRs of at least 12 mo were included in the analysis. The primary outcomes were RRs at 12 and 24 mo. The secondary outcomes were reported adverse effects. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of the evidence.
EVIDENCE SYNTHESIS
Twelve randomised controlled trials (2288 patients) were included for the meta-analysis. PDD was found to reduce RRs at 12 mo (RR 0.73, confidence interval [CI] 0.60-0.88) and 24 mo (RR 0.75, CI 0.62-0.91). There was an increased risk of recurrence for patients undergoing WL at 12 mo (hazard ratio [HR] 1.14, CI 1.05-1.23) and 24 mo (HR 1.25, CI 1.15-1.35). Two studies reported recurrence data at 60 mo showing statistically significant outcomes in favour of PDD: one showed lower RRs for PDD (49% PDD vs 68% WL), whilst the other showed increased recurrence-free survival (68.2% PDD vs 57.3% WL). Adverse effects appeared to be minimal, though poorly reported. A GRADE analysis showed the evidence to be of moderate certainty overall.
CONCLUSIONS
This systematic review found that PDD reduced RRs and improved recurrence-free survival compared with WL in NMIBC over at least 2-yr follow-up. These effects may persist up to 5 yr. Further research in a pragmatic study looking at longer-term outcomes beyond 24 mo will help guide recommendations on clinical adoption.
PATIENT SUMMARY
This review suggests that photodynamic diagnosis, compared with white light cystoscopy, improves recurrence-free survival in non-muscle-invasive bladder cancer over at least 2 yr of follow-up. However, confirmatory pragmatic studies with longer-term outcomes are required for its clinical adoption.
PubMed: 34467237
DOI: 10.1016/j.euros.2021.06.011 -
EClinicalMedicine Aug 2021Osteoporosis affects over half of adults over 50 years worldwide. With an ageing population, osteoporosis, fractures and their associated costs are increasing....
BACKGROUND
Osteoporosis affects over half of adults over 50 years worldwide. With an ageing population, osteoporosis, fractures and their associated costs are increasing. Unfortunately, despite effective therapies, many with osteoporosis remain undiagnosed and untreated. Models of care (MoC) to improve outcomes include fracture liaison services, screening, education, and exercise programs, however efficacy for these is mixed. The aim of this study is to summarise MoC in osteoporosis and describe implementation characteristics and evidence for improving outcomes.
METHODS
This systematic scoping review identified articles via Ovid Medline and Embase, published in English between 01/01/2009 and 15/06/2021, describing MoC for adults aged ≥18 years with, or at risk of, osteoporosis and / or health professionals caring for this group. All included at least one of clinical, consumer or clinician outcomes, with fractures and bone mineral density (BMD) change the primary clinical outcomes. Exclusion criteria were studies assessing pharmaceuticals or procedures without other interventions, or insufficient operational details. All study designs were included, with no comparator necessary. Title and abstract were reviewed by two reviewers. Full text review and data extraction was performed by these reviewers for 20% of article and, thereafter by a single author. As the review was predominantly descriptive, no comparator statistics were used.
FINDINGS
314 articles were identified describing 289 MoC with fracture liaison services =89) and education programs (=86) predominating. The population had prior fragility fracture in 77 studies, the median (IQR) patient number was 210 (87, 667) and the median (IQR) follow-up duration for outcome assessment was 12 (6, 12·5) months. Fracture reduction was reported by 65 studies, with 16 (37%) graded as high quality, and 19 / 47 studies with a comparator group found a reduction in fractures. BMD change was reported by 73 studies, with 41 finding improved BMD. Implementation characteristics including reach, fidelity and loss to follow-up were under-reported, and consumer and clinician perspectives rare.
INTERPRETATION
This comprehensive review of MoC for osteoporosis demonstrated inconsistent evidence for improving outcomes despite similar types of models. Future studies should include implementation outcomes, consumer and clinician perspectives, and fracture or BMD outcomes with sufficient duration of follow-up. Authors should consider pragmatic trial designs and co-design with clinicians and consumers.
PubMed: 34345811
DOI: 10.1016/j.eclinm.2021.101022 -
BMJ Open Mar 2022The inappropriate use of antibiotics is a key driver of antimicrobial resistance. In China, antibiotic prescribing and consumption exceed recommended levels and are...
INTRODUCTION
The inappropriate use of antibiotics is a key driver of antimicrobial resistance. In China, antibiotic prescribing and consumption exceed recommended levels and are relatively high internationally. Understanding the influences on antibiotic use is essential to informing effective evidence-based interventions. We conducted a scoping review to obtain an overview of empirical research about key behavioural, cultural, economic and social influences on antibiotic use in China.
METHODS
Searches were conducted in Econlit, Medline, PsycINFO, Social Science citation index and the Cochrane Database of Systematic Reviews for the period 2003 to early 2018. All study types were eligible including observational and intervention, qualitative and quantitative designs based in community and clinical settings. Two authors independently screened studies for inclusion. A data extraction form was developed incorporating details on study design, behaviour related to antibiotic use, influences on behaviour and information on effect (intervention studies only).
RESULTS
Intervention studies increased markedly from 2014, and largely focused on the impact of national policy and practice directives on antibiotic use in secondary and tertiary healthcare contexts in China. Most studies used pragmatic designs, such as before and after comparisons. Influences on antibiotic use clustered under four themes: antibiotic prescribing; adherence to antibiotics; self-medicating behaviour and over-the-counter sale of antibiotics. Many studies highlighted the use of antibiotics without a prescription for common infections, which was facilitated by availability of left-over medicines and procurement from local pharmacies.
CONCLUSIONS
Interventions aimed at modifying antibiotic prescribing behaviour show evidence of positive impact, but further research using more robust research designs, such as randomised trials, and incorporating process evaluations is required to better assess outcomes. The effect of national policy at the primary healthcare level needs to be evaluated and further exploration of the influences on antibiotic self-medicating is required to develop interventions that tackle this behaviour.
Topics: Anti-Bacterial Agents; Bacterial Infections; China; Humans
PubMed: 35338063
DOI: 10.1136/bmjopen-2021-056348 -
European Journal of Orthopaedic Surgery... Dec 2022The recent past has seen a significant increase in the number of trauma and orthopaedic randomised clinical trials published in "the big five" general medical journals.... (Review)
Review
INTRODUCTION
The recent past has seen a significant increase in the number of trauma and orthopaedic randomised clinical trials published in "the big five" general medical journals. The quality of this research has, however, not yet been established.
METHODS
We therefore set out to critically appraise the quality of available literature over a 10-year period (April 2010-April 2020) through a systematic search of these 5 high-impact general medical journals (JAMA, NEJM, BMJ, Lancet and Annals). A standardised data extraction proforma was utilised to gather information regarding: trial design, sample size calculation, results, study quality and pragmatism. Quality assessment was performed using the Cochrane Risk of Bias 2 tool and the modified Delphi list. Study pragmatism was assessed using the PRECIS-2 tool.
RESULTS
A total of 25 studies were eligible for inclusion. Over half of the included trials did not meet their sample size calculation for the primary outcome, with a similar proportion of these studies at risk of type II error for their non-significant results. There was a high degree of pragmatism according to PRECIS-2. Non-significant studies had greater pragmatism that those with statistically significant results (p < 0.001). Only 56% studies provided adequate justification for the minimum clinically important difference (MCID) in the population assessed. Overall, very few studies were deemed high quality/low risk of bias.
CONCLUSIONS
These findings highlight that there are some important methodological concerns present within the current evidence base of RCTs published in high-impact medical journals. Potential strategies that may improve future trial design are highlighted.
LEVEL OF EVIDENCE
Level 1.
Topics: Humans; Bias; Orthopedics; Periodicals as Topic; Randomized Controlled Trials as Topic
PubMed: 34613468
DOI: 10.1007/s00590-021-03137-3 -
BMJ (Clinical Research Ed.) Dec 2019To determine the effectiveness of management strategies for uninvestigated dyspepsia. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To determine the effectiveness of management strategies for uninvestigated dyspepsia.
DESIGN
Systematic review and network meta-analysis.
DATA SOURCES
Medline, Embase, Embase Classic, the Cochrane Central Register of Controlled Trials, and clinicaltrials.gov from inception to September 2019, with no language restrictions. Conference proceedings between 2001 and 2019.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES
Randomised controlled trials that assessed the effectiveness of management strategies for uninvestigated dyspepsia in adult participants (age ≥18 years). Strategies of interest were prompt endoscopy; test for and perform endoscopy in participants who test positive; test for and eradication treatment in those who test positive ("test and treat"); empirical acid suppression; or symptom based management. Trials reported dichotomous assessment of symptom status at final follow-up (≥12 months).
RESULTS
The review identified 15 eligible randomised controlled trials that comprised 6162 adult participants. Data were pooled using a random effects model. Strategies were ranked according to P score, which is the mean extent of certainty that one management strategy is better than another, averaged over all competing strategies. "Test and treat" ranked first (relative risk of remaining symptomatic 0.89, 95% confidence interval 0.78 to 1.02, P score 0.79) and prompt endoscopy ranked second, but performed similarly (0.90, 0.80 to 1.02, P score 0.71). However, no strategy was significantly less effective than "test and treat." Participants assigned to "test and treat" were significantly less likely to receive endoscopy (relative risk prompt endoscopy 0.23, 95% confidence interval 0.17 to 0.31, P score 0.98) than all other strategies, except symptom based management (relative risk symptom based management 0.60, 0.30 to 1.18). Dissatisfaction with management was significantly lower with prompt endoscopy (P score 0.95) than with "test and treat" (relative risk "test and treat" 0.67, 0.46 to 0.98), and empirical acid suppression (relative risk empirical acid suppression 0.58, 0.37 to 0.91). Upper gastrointestinal cancer rates were low in all trials. Results remained stable in sensitivity analyses, with minimal inconsistencies between direct and indirect results. Risk of bias of individual trials was high; blinding was not possible because of the pragmatic trial design.
CONCLUSIONS
"Test and treat" was ranked first, although it performed similarly to prompt endoscopy and was not superior to any of the other strategies. "Test and treat" led to fewer endoscopies than all other approaches, except symptom based management. However, participants showed a preference for prompt endoscopy as a management strategy for their symptoms.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO registration number CRD42019132528.
Topics: Anti-Bacterial Agents; Dyspepsia; Gastrointestinal Agents; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Network Meta-Analysis
PubMed: 31826881
DOI: 10.1136/bmj.l6483 -
A Scoping Review of Peer Navigation Programs for People Living with HIV: Form, Function and Effects.AIDS and Behavior Dec 2022This scoping review maps recent research into peer navigation programs for people living with HIV. Four databases were systematically searched in June 2020. Results were... (Review)
Review
This scoping review maps recent research into peer navigation programs for people living with HIV. Four databases were systematically searched in June 2020. Results were screened according to defined criteria and were not restricted to any design, outcome or country. Six papers drew from randomised control trials, five from quasi-experimental or pragmatic trials, and four panel, eight qualitative, three mixed method and one cross-sectional designs were included for review. Programs incorporated health systems navigation and social support. Authors provided strong theoretical bases for peers to enhance program effects. Studies primarily reported program effects on continuum of care outcomes. Further research is required to capture the role HIV peer navigators play in preventing disease and promoting quality of life, mental health, and disease self-management in diverse settings and populations. Peer programs are complex, social interventions. Future work should evaluate detailed information about peer navigators, their activities, the quality of peer engagement as well as employee and community support structures to improve quality and impact.
Topics: Humans; Quality of Life; Cross-Sectional Studies; HIV Infections; Peer Group; Social Support
PubMed: 35672548
DOI: 10.1007/s10461-022-03729-y -
Inquiry : a Journal of Medical Care... 2021Bladder cancer (BC) is the 10 most common malignancy worldwide and the patient experience is found to be worse than that for patients diagnosed with other cancer types....
Bladder cancer (BC) is the 10 most common malignancy worldwide and the patient experience is found to be worse than that for patients diagnosed with other cancer types. We aimed to develop a wellbeing intervention to help improve the bladder cancer patient experience by ameliorating their health-related Quality of Life (HRQoL). We followed the 3 phases of the modified Medical Research Council (MRC) Framework for development of complex interventions. Following a systematic review of the literature on mental, sexual, and physical wellbeing, we conducted discussion groups with patients and healthcare professionals on these 3 themes. A consultation phase was then conducted with all relevant stakeholders to co-design a wellbeing intervention as part of a feasibility study. A pragmatic wellbeing feasibility trial was designed based on the hypothesis that a wellbeing program will increase patient awareness and attendance to services available to them and will better support their needs to improve HRQoL. The primary feasibility endpoints are patient attendance to the services offered and changes in HRQoL. The principle of patient centered care has strengthened the commitment to provide a holistic approach to support BC patients. In this study, we developed a wellbeing intervention in collaboration with patients and healthcare professionals to meet an unmet need in terms of the BC patient experience.
Topics: Feasibility Studies; Health Personnel; Humans; Patient Outcome Assessment; Quality of Life; Urinary Bladder Neoplasms
PubMed: 34271831
DOI: 10.1177/00469580211030217