The effects of radiofrequency exposure on male fertility: A systematic review of human observational studies with dose-response meta-analysis.

BACKGROUND: The World Health Organization (WHO) is bringing together evidence on radiofrequency electromagnetic field (RF-EMF) exposure in relation to health outcomes, previously identified as priorities for research and evaluation by experts in the field, to inform exposure guidelines. A suite of systematic reviews have been undertaken by a network of topic experts and methodologists to collect, assess and synthesise data relevant to these guidelines. Following the WHO handbook for guideline development and the COSTER conduct guidelines, we systematically reviewed the evidence on the potential effects of RF-EMF exposure on male fertility in human observational studies. METHODS: We conducted a broad and sensitive search for potentially relevant records within the following bibliographic databases: MEDLINE; Embase; Web of Science and EMF Portal. We also conducted searches of grey literature through relevant databases including OpenGrey, and organisational websites and consulted RF-EMF experts. We hand searched reference lists of included study records and for citations of these studies. We included quantitative human observational studies on the effect of RF-EMF exposure in adult male participants on infertility: sperm concentration; sperm morphology; sperm total motility; sperm progressive motility; total sperm count; and time to pregnancy. Titles and abstracts followed by full texts were screened in blinded duplicate against pre-set eligibility criteria with consensus input from a third reviewer as required. Data extraction from included studies was completed by two reviewers, as was risk of bias assessment using the Office of Health Assessment and Translation (OHAT) tool. We conducted a dose-response meta-analysis as possible and appropriate. Certainty of the evidence was assessed by two reviewers using the OHAT GRADE tool with input from a third reviewer as required. RESULTS: We identified nine studies in this review; seven were general public studies (with the general public as the population of interest) and two were occupational studies (with specific workers/workforces as the population of interest). General public studies. Duration of phone use: The evidence is very uncertain surrounding the effects of RF-EMF on sperm concentration (10/6 mL) (MD (mean difference) per hour of daily phone use 1.6 106/mL, 95 % CI -1.7 to 4.9; 3 studies), sperm morphology (MD 0.15 percentage points of deviation of normal forms per hour, 95 % CI -0.21 to 0.51; 3 studies), sperm progressive motility (MD -0.46 percentage points per hour, 95 % CI -1.04 to 0.13; 2 studies) and total sperm count (MD per hour -0.44 106/ejaculate, 95 % CI -2.59 to 1.7; 2 studies) due to very low-certainty evidence. Four additional studies reported on the effect of mobile phone use on sperm motility but were unsuitable for pooling; only one of these studies identified a statistically significant effect. All four studies were at risk of exposure characterisation and selection bias; two of confounding, selective reporting and attrition bias; three of outcome assessment bias and one used an inappropriate statistical method. Position of phone: There may be no or little effect of carrying a mobile phone in the front pocket on sperm concentration, total count, morphology, progressive motility or on time to pregnancy. Of three studies reporting on the effect of mobile phone location on sperm total motility and, or, total motile count, one showed a statistically significant effect. All three studies were at risk of exposure characterisation and selection bias; two of confounding, selective reporting and attrition bias; three of outcome assessment bias and one used inappropriate statistical method. RF-EMF Source: One study indicates there may be little or no effect of computer or other electric device use on sperm concentration, total motility or total count. This study is at probably high risk of exposure characterisation bias and outcome assessment bias. Occupational studies. With only two studies of occupational exposure to RF-EMF and heterogeneity in the population and exposure source (technicians exposed to microwaves or seamen exposed to radar equipment), it was not plausible to statistically pool findings. One study was at probably or definitely high risk of bias across all domains, the other across domains for exposure characterisation bias, outcome assessment bias and confounding. DISCUSSION: The majority of evidence identified was assessing localised RF-EMF exposure from mobile phone use on male fertility with few studies assessing the impact of phone position. Overall, the evidence identified is very uncertain about the effect of RF-EMF exposure from mobile phones on sperm outcomes. One study assessed the impact of other RF-EMF sources on male fertility amongst the general public and two studies assessed the impact of RF-EMF exposure in occupational cohorts from different sources (radar or microwave) on male fertility. Further prospective studies conducted with greater rigour (in particular, improved accuracy of exposure measurement and appropriate statistical method use) would build the existing evidence base and are required to have greater certainty in any potential effects of RF-EMF on male reproductive outcomes. Prospero Registration: CRD42021265401 (SR3A).

The effects of radiofrequency exposure on adverse female reproductive outcomes: A systematic review of human observational studies with dose-response meta-analysis.

BACKGROUND: To inform radiofrequency electromagnetic field (RF-EMF) exposure guidelines the World Health Organization (WHO) is bringing together evidence on RF-EMF in relation to health outcomes prioritised for evaluation by experts in this field. Given this, a network of topic experts and methodologists have conducted a series of systematic reviews collecting, assessing, and synthesising data of relevance to these guidelines. Here we present a systematic review of the effect of RF-EMF exposure on adverse pregnancy outcomes in human observational studies which follows the WHO handbook for guideline development and the COSTER conduct guidelines. METHODS: We conducted a broad, sensitive search for potentially relevant records within the following bibliographic databases: MEDLINE; Embase; and the EMF Portal. Grey literature searches were also conducted through relevant databases (including OpenGrey), organisational websites and via consultation of RF-EMF experts. We included quantitative human observational studies on the effect of RF-EMF exposure in adults' preconception or pregnant women on pre-term birth, small for gestational age (SGA; associated with intrauterine growth restriction), miscarriage, stillbirth, low birth weight (LBW) and congenital anomalies. In blinded duplicate, titles and abstracts then full texts were screened against eligibility criteria. A third reviewer gave input when consensus was not reached. Citation chaining of included studies was completed. Two reviewers' data extracted and assessed included studies for risk of bias using the Office of Health Assessment and Translation (OHAT) tool. Random effects meta-analyses of the highest versus the lowest exposures and dose-response meta-analysis were conducted as appropriate and plausible. Two reviewers assessed the certainty in each body of evidence using the OHAT GRADE tool. RESULTS: We identified 18 studies in this review; eight were general public studies (with the general public as the population of interest) and 10 were occupational studies (with the population of interest specific workers/workforces). General public studies. From pairwise meta-analyses of general public studies, the evidence is very uncertain about the effects of RF-EMF from mobile phone exposure on preterm birth risk (relative risk (RR) 1.14, 95% confidence interval (CI): 0.97-1.34, 95% prediction interval (PI): 0.83-1.57; 4 studies), LBW (RR 1.14, 95% CI: 0.96-1.36, 95% PI: 0.84-1.57; 4 studies) or SGA (RR 1.13, 95% CI: 1.02-1.24, 95% PI: 0.99-1.28; 2 studies) due to very low-certainty evidence. It was not feasible to meta-analyse studies reporting on the effect of RF-EMF from mobile phone exposure on congenital anomalies or miscarriage risk. The reported effects from the studies assessing these outcomes varied and the studies were at some risk of bias. No studies of the general public assessed the impact of RF-EMF exposure on stillbirth. Occupational studies. In occupational studies, based on dose-response meta-analyses, the evidence is very uncertain about the effects of RF-EMF amongst female physiotherapists using shortwave diathermy on miscarriage due to very low-certainty evidence (OR 1.02 95% CI 0.94-1.1; 2 studies). Amongst offspring of female physiotherapists using shortwave diathermy, the evidence is very uncertain about the effects of RF-EMF on the risk of congenital malformations due to very low-certainty evidence (OR 1.4, 95% CI 0.85 to 2.32; 2 studies). From pairwise meta-analyses, the evidence is very uncertain about the effects of RF-EMF on the risk of miscarriage (RR 1.06, 95% CI 0.96 to 1.18; very low-certainty evidence), pre-term births (RR 1.19, 95% CI 0.32 to 4.37; 3 studies; very low-certainty evidence), and low birth weight (RR 2.90, 95% CI: 0.69 to 12.23; 3 studies; very low-certainty evidence). Results for stillbirth and SGA could not be pooled in meta-analyses. The results from the studies reporting these outcomes were inconsistent and the studies were at some risk of bias. DISCUSSION: Most of the evidence identified in this review was from general public studies assessing localised RF-EMF exposure from mobile phone use on female reproductive outcomes. In occupational settings, each study was of heterogenous whole-body RF-EMF exposure from radar, short or microwave diathermy, surveillance and welding equipment and its effect on female reproductive outcomes. Overall, the body of evidence is very uncertain about the effect of RF-EMF exposure on female reproductive outcomes. Further prospective studies conducted with greater rigour (particularly improved accuracy of exposure measurement and using appropriate statistical methods) are required to identify any potential effects of RF-EMF exposure on female reproductive outcomes of interest.

Effectiveness of dance interventions for falls prevention in older adults: systematic review and meta-analysis.

INTRODUCTION: Fall prevention is a global health priority. Strength and balance exercise programmes are effective at reducing falls. Emerging literature suggests dance is an enjoyable and sociable form of exercise. However, there is little evidence that dance reduces fall incidence. METHODS: Systematic review and meta-analysis examining effectiveness and cost-effectiveness of dance for falls prevention in older adults. Five databases were searched with no restrictions on publication date or intervention settings. Risk of bias was assessed using variants of Cochrane Risk of bias tools, Mixed-Methods Appraisal and Drummond checklist as appropriate. Certainty of evidence was assessed using GRADE. RESULTS: Forty-one studies were included (19 RCTs, 13 quasi-experimental, two mixed-method, seven observational studies, 2,451 participants). Five types of dance interventions were identified: ballroom and Latin dance, dance exercise, cultural dance, dance therapy, and low-impact dance. Meta-analysis was only possible for functional outcome measures: Timed-Up-and-Go (dance versus usual care, mean difference (MD) = 1.36; 95% CI -3.57 to 0.85), Sit-to-Stand (dance versus exercise MD = -0.85; 95% CI -2.64 to 0.93: dance versus education MD = -1.64; 95% CI -4.12 to 0.85), Berg Balance Scale (dance versus usual care MD = 0.61; 95% CI -4.26 to 5.47). There was unexplained variance in effects and no significant differences between intervention and control groups. Overall, certainty of evidence was very low; we are uncertain about the effect of dance interventions in reducing falls. CONCLUSIONS: There is very low certainty evidence for dance as an alternative to strength and balance training if the aim is to prevent falls. No robust evidence on the cost-effectiveness of dance interventions for the prevention of falls was found. PROSPERO REGISTRATION: CRD42022382908.

Improving oral health and related health behaviours (substance use, smoking, diet) in people with severe and multiple disadvantage: A systematic review of effectiveness and cost-effectiveness of interventions.

BACKGROUND: People experiencing homelessness co-occurring with substance use or offending ('severe and multiple disadvantage' SMD) often have high levels of poor oral health and related health behaviours (particularly, substance use, smoking, poor diet). This systematic review aimed to assess the effectiveness and cost-effectiveness of interventions in adults experiencing SMD to improve oral health and related health behaviours. METHODS AND FINDINGS: From inception to February 2023, five bibliographic databases (MEDLINE, EMBASE, PsycINFO, CINAHL, and Scopus) and grey literature were searched. Two researchers independently screened the search results. Randomized controlled trials (RCTs), comparative studies and economic evaluations were included that reported outcomes on oral health and the related health behaviours. Risk of bias was assessed and results narratively synthesized. Meta-analyses were performed where appropriate. This review was registered with PROSPERO (reg. no: CRD42020202416). Thirty-eight studies were included (published between 1991 and 2023) with 34 studies reporting about effectiveness. Most studies reported on substance use (n = 30). Interventions with a combination of housing support with substance use and mental health support such as contingent work therapy appeared to show some reduction in substance use in SMD groups. However, meta-analyses showed no statistically significant results. Most studies had short periods of follow-up and high attrition rates. Only one study reported on oral health; none reported on diet. Three RCTs reported on smoking, of which one comprising nicotine replacement with contingency management showed improved smoking abstinence at 4 weeks compared to control. Five studies with economic evaluations provided some evidence that interventions such as Housing First and enhanced support could be cost-effective in reducing substance use. CONCLUSION: This review found that services such as housing combined with other healthcare services could be effective in improving health behaviours, particularly substance use, among SMD groups. Gaps in evidence also remain on oral health improvement, smoking, and diet. High quality studies on effectiveness with adequate power and retention are needed to address these significant health challenges in SMD populations.

Interventions for cold homes: a rapid review of the health impacts.

BACKGROUND: Cold homes are associated with an increased risk of adverse health outcomes for older people. To mitigate this risk, homes need to be heated to an appropriate temperature. This review aims to identify interventions designed to improve heating and temperatures within homes and summarize its impact on health, health service utilization and cost effectiveness. METHODS: A rapid review was conducted. Studies assessing the effects of structural, financial, or behavioural interventions designed to improve home temperatures of residents aged 18+ years were eligible. Searches were carried out in four databases. A search for grey literature, and backward and forward citation searching were performed. Data were summarized in a narrative synthesis and mapped using EPPI-Reviewer and EPPI-Mapper software. RESULTS: Eighteen studies reported across 19 publications were included. Structural interventions were associated with better mental health and quality of life, a reduction in health service utilization, and improvements in satisfaction with internal home temperature, social interactions and financial difficulties. The impact on physical health outcomes varied by age, gender and long-term conditions. Evidence about the impact of behavioural interventions was inconsistent. CONCLUSION: Structural improvements to increase home temperatures may offer the potential to improve some aspects of health. However, the impact on physical health, including which groups are most likely to benefit, is unclear. Key gaps include the lack of evidence about the impact of financial interventions, and the impact of all types of interventions, on quality of life, mortality and costs.

Effectiveness of shared medical appointments delivered in primary care for improving health outcomes in patients with long-term conditions: a systematic review of randomised controlled trials.

OBJECTIVES: To examine the effectiveness of shared medical appointments (SMAs) compared with one-to-one appointments in primary care for improving health outcomes and reducing demand on healthcare services by people with one or more long-term conditions (LTCs). DESIGN: A systematic review of the published literature. DATA SOURCES: Six databases, including MEDLINE and Web of Science, were searched 2013-2023. Relevant pre-2013 trials identified by forward and backward citation searches of the included trials were included. ELIGIBILITY CRITERIA: Randomised controlled trials of SMAs delivered in a primary care setting involving adults over 18 years with one or more LTCs. Studies were excluded if the SMA did not include one-to-one patient-clinician time. All countries were eligible for inclusion. DATA EXTRACTION AND SYNTHESIS: Data were extracted and outcomes narratively synthesised, meta-analysis was undertaken where possible. RESULTS: Twenty-nine unique trials were included. SMA models varied in terms of components, mode of delivery and target population. Most trials recruited patients with a single LTC, most commonly diabetes (n=16). There was substantial heterogeneity in outcome measures. Meta-analysis showed that participants in SMA groups had lower diastolic blood pressure than those in usual care (d=-0.086, 95% CI=-0.16 to -0.02, n=10) (p=0.014). No statistically significant differences were found across other outcomes. Compared with usual care, SMAs had no significant effect on healthcare service use. For example, no difference between SMAs and usual care was found for admissions to emergency departments at follow-up (d=-0.094, 95% CI=-0.27 to 0.08, n=6, p=0.289). CONCLUSIONS: There was a little difference in the effectiveness of SMAs compared with usual care in terms of health outcomes or healthcare service use in the short-term (range 12 weeks to 24 months). To strengthen the evidence base, future studies should include a wider array of LTCs, standardised outcome measures and more details on SMA components to help inform economic evaluation. PROSPERO REGISTRATION NUMBER: CRD42020173084.

What works to support carers of older people and older carers? an international evidence map of interventions and outcomes.

BACKGROUND: Unpaid carers of older people, and older unpaid carers, experience a range of adverse outcomes. Supporting carers should therefore be a public health priority. Our understanding of what works to support carers could be enhanced if future evaluations prioritise under-researched interventions and outcomes. To support this, we aimed to: map evidence about interventions to support carers, and the outcomes evaluated; and identify key gaps in current evidence. METHODS: Evidence gap map review methods were used. Searches were carried out in three bibliographic databases for quantitative evaluations of carer interventions published in OECD high-income countries between 2013 and 2023. Interventions were eligible if they supported older carers (50 + years) of any aged recipient, or any aged carers of older people (50 + years). FINDINGS: 205 studies reported across 208 publications were included in the evidence map. The majority evaluated the impact of therapeutic and educational interventions on carer burden and carers' mental health. Some studies reported evidence about physical exercise interventions and befriending and peer support for carers, but these considered a limited range of outcomes. Few studies evaluated interventions that focused on delivering financial information and advice, pain management, and physical skills training for carers. Evaluations rarely considered the impact of interventions on carers' physical health, quality of life, and social and financial wellbeing. Very few studies considered whether interventions delivered equitable outcomes. CONCLUSION: Evidence on what works best to support carers is extensive but limited in scope. A disproportionate focus on mental health and burden outcomes neglects other important areas where carers may need support. Given the impact of caring on carers' physical health, financial and social wellbeing, future research could evaluate interventions that aim to support these outcomes. Appraisal of whether interventions deliver equitable outcomes across diverse carer populations is critical.

Factors influencing implementation and sustainability of interventions to improve oral health and related health behaviours in adults experiencing severe and multiple disadvantage: a mixed-methods systematic review.

OBJECTIVES: Among people experiencing severe and multiple disadvantage (SMD), poor oral health is common and linked to smoking, substance use and high sugar intake. Studies have explored interventions addressing oral health and related behaviours; however, factors related to the implementation of these interventions remain unclear. This mixed-methods systematic review aimed to synthesise evidence on the implementation and sustainability of interventions to improve oral health and related health behaviours among adults experiencing SMD. METHODS: Bibliographic databases (MEDLINE, EMBASE, PsycINFO, CINAHL, EBSCO, Scopus) and grey literature were searched from inception to February 2023. Studies meeting the inclusion criteria were screened and extracted independently by two researchers. Quality appraisal was undertaken, and results were synthesised using narrative and thematic analyses. RESULTS: Seventeen papers were included (published between 1995 and 2022). Studies were mostly of moderate quality and included views from SMD groups and service providers. From the qualitative synthesis, most findings were related to aspects such as trust, resources and motivation levels of SMD groups and service providers. None of the studies reported on diet and none included repeated offending (one of the aspects of SMD). From the quantitative synthesis, no difference was observed in programme attendance between the interventions and usual care, although there was some indication of sustained improvements in participation in the intervention group. CONCLUSION: This review provides some evidence that trust, adequate resources and motivation levels are potentially important in implementing interventions to improve oral health and substance use among SMD groups. Further research is needed from high quality studies and focusing on diet in this population. PROSPERO REGISTRATION NUMBER: CRD42020202416.

Interventions to improve oral health and related health behaviours of substance use, smoking, and diet in people with severe and multiple disadvantage: a systematic review of effectiveness and cost-effectiveness.

BACKGROUND: Homelessness overlapping with substance use and offending is described as severe and multiple disadvantage (SMD). People experiencing SMD have poor oral health along with high levels of related behaviours such as substance use, smoking, and poor diet. Existing evidence largely describes the prevalence of oral health problems, substance use, and smoking in SMD groups. Little is known about interventions that can address these conditions in SMD groups. We aimed to review the effectiveness and cost-effectiveness of interventions on oral health and related health behaviours in adults experiencing SMD. METHODS: For this systematic review, we searched bibliographic databases (MEDLINE, EMBASE, PsycINFO, CINAHL, EBSCO, Scopus) and grey literature for papers published from inception to February 2023. Two researchers independently reviewed the searches. Randomised controlled trials (RCTs), comparative studies and economic evaluations were included. Risk of bias was assessed. Population included adults experiencing SMD (including homelessness and substance use or repeat offending). Outcomes included oral health, and related behaviours (substance use, smoking, poor diet). Results were narratively synthesised. This review was registered with PROSPERO, CRD42020202416. FINDINGS: The review included 38 studies (published between 1991 and 2023), with 34 reporting effectiveness. These studies comprised of 23 RCTs and 11 quasi-experimental studies conducted in the USA (25 studies), Canada (seven studies), France (one study), and Spain (one study). The interventions involving multiple components, such as housing services with substance use and mental health support, effectively reduced substance use in SMD groups; these were mostly individual-level interventions. However, these studies had short follow-up periods and high attrition rates. Only one study addressed oral health outcomes, none focused on diet, and three RCTs covered smoking, with one intervention showing smoking abstinence at 4 weeks. Some limited evidence suggested cost-effectiveness of substance use interventions. INTERPRETATION: This review found that integrating services such as housing with other health-care services together could be effective in improving health behaviours, especially substance use among SMD groups. More evidence is needed specifically on oral health, smoking, and diet-related interventions. The generalisability of findings of this review is limited to high-income countries and shorter-term outcomes. FUNDING: National Institute for Health and Care Research (NIHR) Policy Research Programme.

Looking at the fringes of MedTech innovation: a mapping review of horizon scanning and foresight methods.

OBJECTIVES: Horizon scanning (HS) is a method used to examine signs of change and may be used in foresight practice. HS methods used for the identification of innovative medicinal products cannot be applied in medical technologies (MedTech) due to differences in development and regulatory processes. The aim of this study is to identify HS and other methodologies used for MedTech foresight in support to healthcare decision-making. METHOD: A mapping review was performed. We searched bibliographical databases including MEDLINE, Embase, Scopus, Web of Science, IEEE Xplore and Compendex Engineering Village and grey literature sources such as Google, CORE database and the International HTA database. Our searches identified 8888 records. After de-duplication, and manual and automated title, abstracts and full-text screening, 49 papers met the inclusion criteria and were data extracted. RESULTS: Twenty-five single different methods were identified, often used in combination; of these, only three were novel (appearing only once in the literature). Text mining or artificial intelligence solutions appear as early as 2012, often practised in patent and social media sources. The time horizon used in scanning was not often justified. Some studies regarded experts both as a source and as a method. Literature searching remains one of the most used methods for innovation identification. HS methods were vaguely reported, but often involved consulting with experts and stakeholders. CONCLUSION: Heterogeneous methodologies, sources and time horizons are used for HS and foresight of MedTech innovation with little or no justification provided for their use. This review revealed an array of known methods being used in combination to overcome the limitations posed by single methods. The review also revealed inconsistency in methods reporting, with a lack of any consensus regarding best practice. Greater transparency in methods reporting and consistency in methods use would contribute to increased output quality to support informed timely decision-making.

Predictive accuracy of risk prediction models for recurrence, metastasis and survival for early-stage cutaneous melanoma: a systematic review.

OBJECTIVES: To identify prognostic models for melanoma survival, recurrence and metastasis among American Joint Committee on Cancer stage I and II patients postsurgery; and evaluate model performance, including overall survival (OS) prediction. DESIGN: Systematic review and narrative synthesis. DATA SOURCES: Searched MEDLINE, Embase, CINAHL, Cochrane Library, Science Citation Index and grey literature sources including cancer and guideline websites from 2000 to September 2021. ELIGIBILITY CRITERIA: Included studies on risk prediction models for stage I and II melanoma in adults ≥18 years. Outcomes included OS, recurrence, metastases and model performance. No language or country of publication restrictions were applied. DATA EXTRACTION AND SYNTHESIS: Two pairs of reviewers independently screened studies, extracted data and assessed the risk of bias using the CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies checklist and the Prediction study Risk of Bias Assessment Tool. Heterogeneous predictors prevented statistical synthesis. RESULTS: From 28 967 records, 15 studies reporting 20 models were included; 8 (stage I), 2 (stage II), 7 (stages I-II) and 7 (stages not reported), but were clearly applicable to early stages. Clinicopathological predictors per model ranged from 3-10. The most common were: ulceration, Breslow thickness/depth, sociodemographic status and site. Where reported, discriminatory values were ≥0.7. Calibration measures showed good matches between predicted and observed rates. None of the studies assessed clinical usefulness of the models. Risk of bias was high in eight models, unclear in nine and low in three. Seven models were internally and externally cross-validated, six models were externally validated and eight models were internally validated. CONCLUSIONS: All models are effective in their predictive performance, however the low quality of the evidence raises concern as to whether current follow-up recommendations following surgical treatment is adequate. Future models should incorporate biomarkers for improved accuracy. PROSPERO REGISTRATION NUMBER: CRD42018086784.

Clinical and cost effectiveness of endoscopic bipolar radiofrequency ablation for the treatment of malignant biliary obstruction: a systematic review.

Background: Early evidence suggests that using radiofrequency ablation as an adjunct to standard care (i.e. endoscopic retrograde cholangiopancreatography with stenting) may improve outcomes in patients with malignant biliary obstruction. Objectives: To assess the clinical effectiveness, cost-effectiveness and potential risks of endoscopic bipolar radiofrequency ablation for malignant biliary obstruction, and the value of future research. Data sources: Seven bibliographic databases, three websites and seven trials registers were searched from 2008 until 21 January 2021. Review methods: The study inclusion criteria were as follows: patients with biliary obstruction caused by any form of unresectable malignancy; the intervention was reported as an endoscopic biliary radiofrequency ablation to ablate malignant tissue that obstructs the bile or pancreatic ducts, either to fit a stent (primary radiofrequency ablation) or to clear an obstructed stent (secondary radiofrequency ablation); the primary outcomes were survival, quality of life or procedure-related adverse events; and the study design was a controlled study, an observational study or a case report. Risk of bias was assessed using Cochrane tools. The primary analysis was meta-analysis of the hazard ratio of mortality. Subgroup analyses were planned according to the type of probe, the type of stent (i.e. metal or plastic) and cancer type. A de novo Markov model was developed to model cost and quality-of-life outcomes associated with radiofrequency ablation in patients with primary advanced bile duct cancer. Insufficient data were available for pancreatic cancer and secondary bile duct cancer. An NHS and Personal Social Services perspective was adopted for the analysis. A probabilistic analysis was conducted to estimate the incremental cost-effectiveness ratio for radiofrequency ablation and the probability that radiofrequency ablation was cost-effective at different thresholds. The population expected value of perfect information was estimated in total and for the effectiveness parameters. Results: Sixty-eight studies (1742 patients) were included in the systematic review. Four studies (336 participants) were combined in a meta-analysis, which showed that the pooled hazard ratio for mortality following primary radiofrequency ablation compared with a stent-only control was 0.34 (95% confidence interval 0.21 to 0.55). Little evidence relating to the impact on quality of life was found. There was no evidence to suggest an increased risk of cholangitis or pancreatitis, but radiofrequency ablation may be associated with an increase in cholecystitis. The results of the cost-effectiveness analysis were that the costs of radiofrequency ablation was £2659 and radiofrequency ablation produced 0.18 quality-adjusted life-years, which was more than no radiofrequency ablation on average. With an incremental cost-effectiveness ratio of £14,392 per quality-adjusted life-year, radiofrequency ablation was likely to be cost-effective at a threshold of £20,000 per quality-adjusted life-year across most scenario analyses, with moderate uncertainty. The source of the vast majority of decision uncertainty lay in the effect of radiofrequency ablation on stent patency. Limitations: Only 6 of 18 comparative studies contributed to the survival meta-analysis, and few data were found concerning secondary radiofrequency ablation. The economic model and cost-effectiveness meta-analysis required simplification because of data limitations. Inconsistencies in standard reporting and study design were noted. Conclusions: Primary radiofrequency ablation increases survival and is likely to be cost-effective. The evidence for the impact of secondary radiofrequency ablation on survival and of quality of life is limited. There was a lack of robust clinical effectiveness data and, therefore, more information is needed for this indication. Future work: Future work investigating radiofrequency ablation must collect quality-of-life data. High-quality randomised controlled trials in secondary radiofrequency ablation are needed, with appropriate outcomes recorded. Study registration: This study is registered as PROSPERO CRD42020170233. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 7. See the NIHR Journals Library website for further project information.

The bile and pancreatic ducts transport fluids to the intestines to help people digest their food properly. Some types of cancer can cause these ducts to become totally or partially blocked. We wanted to know if endoscopic radiofrequency ablation is safe and works well to treat people who have one of these blockages that cannot be removed by surgery. Radiofrequency ablation burns away a blockage by hitting it with radio waves. Endoscopic means that the radio waves are directed to the blockage using a thin, tube-like wire with a camera at the end. During radiofrequency ablation, a person might have a small tube called a stent put into their bile or pancreatic duct to keep it open or to replace an already blocked stent.

We searched for research studies that looked at (1) whether or not radiofrequency ablation was able to remove blockages from the ducts, (2) if radiofrequency ablation allowed people to live longer, (3) if patients had a better quality of life after radiofrequency ablation, (4) if radiofrequency ablation caused any side effects and (5) how much it costs to treat people with radiofrequency ablation.

We found that treatment with radiofrequency ablation before giving a person a stent helped them to live a little longer with their cancer. We did not find any evidence that radiofrequency ablation increased pain or swelling in the bile duct or pancreatic duct. Radiofrequency ablation might cause more swelling in the gall bladder than having a stent without radiofrequency ablation, but there was not enough research available for us to be certain of this.

Radiofrequency ablation before inserting a stent could be a safe option to add to treatment of bile and pancreatic duct blockages caused by cancer. There is limited research evidence and so we are unable to recommend radiofrequency ablation as a treatment for standard clinical practice.

Stakeholder Perspectives of Clinical Artificial Intelligence Implementation: Systematic Review of Qualitative Evidence.

BACKGROUND: The rhetoric surrounding clinical artificial intelligence (AI) often exaggerates its effect on real-world care. Limited understanding of the factors that influence its implementation can perpetuate this. OBJECTIVE: In this qualitative systematic review, we aimed to identify key stakeholders, consolidate their perspectives on clinical AI implementation, and characterize the evidence gaps that future qualitative research should target. METHODS: Ovid-MEDLINE, EBSCO-CINAHL, ACM Digital Library, Science Citation Index-Web of Science, and Scopus were searched for primary qualitative studies on individuals' perspectives on any application of clinical AI worldwide (January 2014-April 2021). The definition of clinical AI includes both rule-based and machine learning-enabled or non-rule-based decision support tools. The language of the reports was not an exclusion criterion. Two independent reviewers performed title, abstract, and full-text screening with a third arbiter of disagreement. Two reviewers assigned the Joanna Briggs Institute 10-point checklist for qualitative research scores for each study. A single reviewer extracted free-text data relevant to clinical AI implementation, noting the stakeholders contributing to each excerpt. The best-fit framework synthesis used the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework. To validate the data and improve accessibility, coauthors representing each emergent stakeholder group codeveloped summaries of the factors most relevant to their respective groups. RESULTS: The initial search yielded 4437 deduplicated articles, with 111 (2.5%) eligible for inclusion (median Joanna Briggs Institute 10-point checklist for qualitative research score, 8/10). Five distinct stakeholder groups emerged from the data: health care professionals (HCPs), patients, carers and other members of the public, developers, health care managers and leaders, and regulators or policy makers, contributing 1204 (70%), 196 (11.4%), 133 (7.7%), 129 (7.5%), and 59 (3.4%) of 1721 eligible excerpts, respectively. All stakeholder groups independently identified a breadth of implementation factors, with each producing data that were mapped between 17 and 24 of the 27 adapted Nonadoption, Abandonment, Scale-up, Spread, and Sustainability subdomains. Most of the factors that stakeholders found influential in the implementation of rule-based clinical AI also applied to non-rule-based clinical AI, with the exception of intellectual property, regulation, and sociocultural attitudes. CONCLUSIONS: Clinical AI implementation is influenced by many interdependent factors, which are in turn influenced by at least 5 distinct stakeholder groups. This implies that effective research and practice of clinical AI implementation should consider multiple stakeholder perspectives. The current underrepresentation of perspectives from stakeholders other than HCPs in the literature may limit the anticipation and management of the factors that influence successful clinical AI implementation. Future research should not only widen the representation of tools and contexts in qualitative research but also specifically investigate the perspectives of all stakeholder HCPs and emerging aspects of non-rule-based clinical AI implementation. TRIAL REGISTRATION: PROSPERO (International Prospective Register of Systematic Reviews) CRD42021256005; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=256005. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/33145.

Are non-invasive or minimally invasive autopsy techniques for detecting cause of death in prenates, neonates and infants accurate? A systematic review of diagnostic test accuracy.

OBJECTIVES: To assess the diagnostic accuracy of non-invasive or minimally invasive autopsy techniques in deaths under 1 year of age. DESIGN: This is a systematic review of diagnostic test accuracy. The protocol is registered on PROSPERO. PARTICIPANTS: Deaths from conception to one adjusted year of age. SEARCH METHODS: MEDLINE (Ovid), EMBASE (Ovid), CINAHL (EBSCO), the Cochrane Library, Scopus and grey literature sources were searched from inception to November 2021. DIAGNOSTIC TESTS: Non-invasive or minimally invasive diagnostic tests as an alternative to traditional autopsy. DATA COLLECTION AND ANALYSIS: Studies were included if participants were under one adjusted year of age, with index tests conducted prior to the reference standard.Data were extracted from eligible studies using piloted forms. Risk of bias was assessed using Quality Assessment of Diagnostic Accuracy Studies-2. A narrative synthesis was conducted following the Synthesis without Meta-Analysis guidelines. Vote counting was used to assess the direction of effect. MAIN OUTCOME MEASURES: Direction of effect was expressed as percentage of patients per study. FINDINGS: We included 54 direct evidence studies (68 articles/trials), encompassing 3268 cases and eight index tests. The direction of effect was positive for postmortem ultrasound and antenatal echography, although with varying levels of success. Conversely, the direction of effect was against virtual autopsy. For the remaining tests, the direction of effect was inconclusive.A further 134 indirect evidence studies (135 articles/trials) were included, encompassing 6242 perinatal cases. The addition of these results had minimal impact on the direct findings yet did reveal other techniques, which may be favourable alternatives to autopsy.Seven trial registrations were included but yielded no results. CONCLUSIONS: Current evidence is insufficient to make firm conclusions about the generalised use of non-invasive or minimally invasive autopsy techniques in relation to all perinatal population groups.PROSPERO registration numberCRD42021223254.

Practitioner and digitally delivered interventions for reducing hazardous and harmful alcohol consumption in people not seeking alcohol treatment: a systematic review and network meta-analysis.

AIM: To compare the effectiveness of practitioner versus digitally delivered interventions for reducing hazardous and harmful alcohol consumption. DESIGN: Systematic review and network meta-analysis comprising comprehensive search for randomised controlled trials, robust screening and selection methods and appraisal with the Cochrane Risk of Bias tool. Network meta-analyses were conducted in Stata using random effects, frequentist models. The confidence in network meta-analysis (CINeMA) tool was used to assess confidence in effect sizes. SETTING: Online or community or health settings where the intervention was immediately accessible without referral. PARTICIPANTS: Non treatment-seeking hazardous or harmful drinkers. MEASUREMENTS: Primary outcome was mean difference in alcohol consumption (g/wk); secondary outcome was number of single high intensity drinking episodes. Baseline consumption was analysed as a covariate. FINDINGS: Of 201 included trials (94 753 participants), 152 reported a consumption outcome that could be converted to grams/week; 104 reported number of single high intensity drinking episodes. At 1 and 6 months, practitioner delivered interventions reduced consumption more than digitally delivered interventions (1 month: -23 g/wk (95% CI, -43 to -2); 6 months: -14 g/wk [95% CI, -25 to -3]). At 12 months there was no evidence of difference between practitioner and digitally delivered interventions (-6 g/wk [95% CI, -24 to 12]). There was no evidence of a difference in single high intensity drinking episodes between practitioner and digitally delivered interventions at any time point. Effect sizes were small, but could impact across a population with relatively high prevalence of hazardous and harmful drinking. Heterogeneity was a concern. Some inconsistency was indicated at 1 and 6 months, but little evidence was apparent at 12 months. CONCLUSION: Practitioner delivered interventions for reducing hazardous and harmful alcohol consumption are more effective than digitally delivered interventions up to 6 months; at 12 months there is no evidence of a difference.

Investigation of text-mining methodologies to aid the construction of search strategies in systematic reviews of diagnostic test accuracy-a case study.

Current methodologies for designing search strategies rely heavily on the knowledge and expertise of information specialists. Yet, the volume and complexity of scientific literature is overwhelming for even the most experienced information specialists, making it difficult to produce robust search strategies for complex systematic reviews. In this case study, we aimed to assess and describe the benefits and limitations of using semi-automated text-mining tools for designing search strategies in a systematic review of diagnostic test accuracy. An experienced information specialist designed a search strategy using traditional methods. This strategy was then amended to include additional terms identified by text-mining tools. We evaluated the usability and expertise required, risk of introducing bias to the search, precision of the search strategy and rated the usefulness of the tools. Thirteen of the 16 investigated tools produced a total of 40 additional terms, beyond those in the original search strategy. This resulted in 11 previously unidentified relevant articles being retrieved. Precision was reduced or remained the same in all cases. After considering all aspects of the investigation we rated each application, with two being 'extremely useful', three being 'useful', three having 'no impact' and eight being 'not very useful'. Comparative analysis revealed discrepancies between similar tools. Our findings have implications for the way in which these methodologies are used and applied to search strategies. If semi-automated techniques are to become mainstream in information retrieval for complex systematic reviews, we need tailored tools that fit information specialists' requirements across disciplines.

Characteristics and Components of Self-Management Interventions for Improving Quality of Life in Cancer Survivors: A Systematic Review.

Self-management can improve clinical and psychosocial outcomes in cancer survivors. Which intervention characteristics and components are beneficial is unclear, hindering implementation into practice. We systematically searched six databases from inception to 17 November 2021 for studies evaluating self-management interventions for adult cancer survivors post-treatment. Independent reviewers screened for eligibility. Data extraction included population and study characteristics, intervention characteristics (TIDieR) and components (PRISMS), (associations with) quality of life (QoL), self-efficacy, and economic outcomes. Study quality was appraised, and narrative synthesis was conducted. We identified 53 papers reporting 32 interventions. Studies had varying quality. They were most often randomised controlled trials (n = 20), targeted at survivors of breast (n = 10), prostate (n = 7), or mixed cancers (n = 11). Intervention characteristics (e.g., provider, location) varied considerably. On average, five (range 1-10) self-management components were delivered, mostly "Information about condition and its management" (n = 26). Twenty-two studies reported significant QoL improvements (6 also reported significant self-efficacy improvements); these were associated most consistently with combined individual and group delivery. Economic evaluations were limited and inconclusive. Self-management interventions showed promise for improving QoL, but study quality was variable, with substantial heterogeneity in intervention characteristics and components. By identifying what to adapt from existing interventions, these findings can inform development and implementation of self-management interventions in cancer.

Factors associated with unmet need for support to maintain independence in later life: a systematic review of quantitative and qualitative evidence.

BACKGROUND: populations are considered to have an 'unmet need' when they could benefit from, but do not get, the necessary support. Policy efforts to achieve equitable access to long-term care require an understanding of patterns of unmet need. A systematic review was conducted to identify factors associated with unmet need for support to maintain independence in later life. METHODS: seven bibliographic databases and four non-bibliographic evidence sources were searched. Quantitative observational studies and qualitative systematic reviews were included if they reported factors associated with unmet need for support to maintain independence in populations aged 50+, in high-income countries. No limits to publication date were imposed. Studies were quality assessed and a narrative synthesis used, supported by forest plots to visualise data. FINDINGS: forty-three quantitative studies and 10 qualitative systematic reviews were included. Evidence across multiple studies suggests that being male, younger age, living alone, having lower levels of income, poor self-rated health, more functional limitations and greater severity of depression were linked to unmet need. Other factors that were reported in single studies were also identified. In the qualitative reviews, care eligibility criteria, the quality, adequacy and absence of care, and cultural and language barriers were implicated in unmet need. CONCLUSIONS: this review identifies which groups of older people may be most at risk of not accessing the support they need to maintain independence. Ongoing monitoring of unmet need is critical to support policy efforts to achieve equal ageing and equitable access to care.

Stakeholder Perspectives on Clinical Decision Support Tools to Inform Clinical Artificial Intelligence Implementation: Protocol for a Framework Synthesis for Qualitative Evidence.

BACKGROUND: Quantitative systematic reviews have identified clinical artificial intelligence (AI)-enabled tools with adequate performance for real-world implementation. To our knowledge, no published report or protocol synthesizes the full breadth of stakeholder perspectives. The absence of such a rigorous foundation perpetuates the "AI chasm," which continues to delay patient benefit. OBJECTIVE: The aim of this research is to synthesize stakeholder perspectives of computerized clinical decision support tools in any health care setting. Synthesized findings will inform future research and the implementation of AI into health care services. METHODS: The search strategy will use MEDLINE (Ovid), Scopus, CINAHL (EBSCO), ACM Digital Library, and Science Citation Index (Web of Science). Following deduplication, title, abstract, and full text screening will be performed by 2 independent reviewers with a third topic expert arbitrating. The quality of included studies will be appraised to support interpretation. Best-fit framework synthesis will be performed, with line-by-line coding completed by 2 independent reviewers. Where appropriate, these findings will be assigned to 1 of 22 a priori themes defined by the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability framework. New domains will be inductively generated for outlying findings. The placement of findings within themes will be reviewed iteratively by a study advisory group including patient and lay representatives. RESULTS: Study registration was obtained from PROSPERO (CRD42021256005) in May 2021. Final searches were executed in April, and screening is ongoing at the time of writing. Full text data analysis is due to be completed in October 2021. We anticipate that the study will be submitted for open-access publication in late 2021. CONCLUSIONS: This paper describes the protocol for a qualitative evidence synthesis aiming to define barriers and facilitators to the implementation of computerized clinical decision support tools from all relevant stakeholders. The results of this study are intended to expedite the delivery of patient benefit from AI-enabled clinical tools. TRIAL REGISTRATION: PROSPERO CRD42021256005; https://tinyurl.com/r4x3thvp. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33145.