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.

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.

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.

The performance of FIT-based and other risk prediction models for colorectal neoplasia in symptomatic patients: a systematic review.

Background: Colorectal cancer (CRC) incidence and mortality are increasing internationally. Endoscopy services are under significant pressure with many overwhelmed. Faecal immunochemical testing (FIT) has been advocated to identify a high-risk population of symptomatic patients requiring definitive investigation by colonoscopy. Combining FIT with other factors in a risk prediction model could further improve performance in identifying those requiring investigation most urgently. We systematically reviewed performance of models predicting risk of CRC and/or advanced colorectal polyps (ACP) in symptomatic patients, with a particular focus on those models including FIT. Methods: The review protocol was published on PROSPERO (CRD42022314710). Searches were conducted from database inception to April 2023 in MEDLINE, EMBASE, Cochrane libraries, SCOPUS and CINAHL. Risk of bias of each study was assessed using The Prediction study Risk Of Bias Assessment Tool. A narrative synthesis based on the guidelines for Synthesis Without Meta-Analysis was performed due to study heterogeneity. Findings: We included 62 studies; 23 included FIT (n = 22) or guaiac Faecal Occult Blood Testing (n = 1) combined with one or more other variables. Twenty-one studies were conducted solely in primary care. Generally, prediction models including FIT consistently had good discriminatory ability for CRC/ACP (i.e. AUC >0.8) and performed better than models without FIT although some models without FIT also performed well. However, many studies did not present calibration and internal and external validation were limited. Two studies were rated as low risk of bias; neither model included FIT. Interpretation: Risk prediction models, including and not including FIT, show promise for identifying those most at risk of colorectal neoplasia. Substantial limitations in evidence remain, including heterogeneity, high risk of bias, and lack of external validation. Further evaluation in studies adhering to gold standard methodology, in appropriate populations, is required before widespread adoption in clinical practice. Funding: National Institute for Health and Care Research (NIHR) [Health Technology Assessment Programme (HTA) Programme (Project number 133852).

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.

Promoting sexual health in older adults: Findings from two rapid reviews.

BACKGROUND: Sexual health throughout the life course is increasingly recognised as important to maintaining one's overall health, wellbeing, and relationships. We aimed to provide an overview of the evidence on sexual health needs and sexual health promotion in later life. METHODS: We undertook two rapid reviews, drawing on systematic review evidence. Searches were conducted in Epistemonikos. Studies were eligible if they reported evidence about the sexual health needs of, or sexual health promotion interventions for, people aged 50+ years. Evidence was quality assessed and summarised in a narrative synthesis. RESULTS: Fifteen systematic reviews were included in Review 1 (sexual health needs) and 12 in Review 2 (interventions). Key concerns and needs of older adults included the impacts of cultural stigma/misperceptions, barriers to sexual expression, and a need for tailored support in a welcoming environment. Key concerns and needs of health and social care professionals included mixed attitudes towards and knowledge of later-life sexuality and a need for more training and education. Approaches to promoting sexual health in later life included training and workshops for care home professionals, education for older people at risk of/living with HIV, and interventions to address sexual health-related symptoms of menopause. Gaps in the evidence from current reviews and methodological issues in primary studies were identified. CONCLUSION: Older people have specific needs relating to their sexual health. Health and social care professionals working with older people may benefit from education/training around sexuality in later life. Evidence on effective interventions and strategies is limited.

Economic evaluations of interventions to prevent and control health-care-associated infections: a systematic review.

Almost 9 million health-care-associated infections have been estimated to occur each year in European hospitals and long-term care facilities, and these lead to an increase in morbidity, mortality, bed occupancy, and duration of hospital stay. The aim of this systematic review was to review the cost-effectiveness of interventions to limit the spread of health-care-associated infections), framed by WHO infection prevention and control core components. The Embase, National Health Service Economic Evaluation Database, Database of Abstracts of Reviews of Effects, Health Technology Assessment, Cinahl, Scopus, Pediatric Economic Database Evaluation, and Global Index Medicus databases, plus grey literature were searched for studies between Jan 1, 2009, and Aug 10, 2022. Studies were included if they reported interventions including hand hygiene, personal protective equipment, national-level or facility-level infection prevention and control programmes, education and training programmes, environmental cleaning, and surveillance. The British Medical Journal checklist was used to assess the quality of economic evaluations. 67 studies were included in the review. 25 studies evaluated methicillin-resistant Staphylococcus aureus outcomes. 31 studies evaluated screening strategies. The assessed studies that met the minimum quality criteria consisted of economic models. There was some evidence that hand hygiene, environmental cleaning, surveillance, and multimodal interventions were cost-effective. There were few or no studies investigating education and training, personal protective equipment or monitoring, and evaluation of interventions. This Review provides a map of cost-effectiveness data, so that policy makers and researchers can identify the relevant data and then assess the quality and generalisability for their setting.

Impacts of health care service changes implemented due to COVID-19 on children and young people with long-term disability: A mapping review.

AIM: To identify the research on childhood disability service adaptations and their impact on children and young people with long-term disability during the COVID-19 pandemic. METHOD: A mapping review was undertaken. We searched the World Health Organization Global COVID-19 database using the search terms 'children', 'chronic/disabling conditions', and 'services/therapies'. Eligible papers reported service changes for children (0-19 years) with long-term disability in any geographical or clinical setting between 1st January 2020 and 26th January 2022. Papers were charted across the effective practice and organization of care taxonomy of health system interventions and were narratively synthesized; an interactive map was produced. RESULTS: Reduction of face-to-face care and usual provision had a huge impact on children and families. Adoption of telehealth provided continuity for the care and management of some conditions. There was limited evidence of changes to mental health services, transitions of care, social care, or child-reported satisfaction or acceptability of service changes. INTERPRETATION: The long-term impacts of service change during the pandemic need full evaluation. However, widespread disruption seems to have had a profound impact on child and carer health and well-being. Service recovery needs to be specific to the individual needs of children with a disability and their families. This should be done through coproduction to ensure that service changes meet needs and are accessible and equitable.

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.

Oral nutritional interventions in frail older people who are malnourished or at risk of malnutrition: a systematic review.

BACKGROUND: Malnutrition worsens the health of frail older adults. Current treatments for malnutrition may include prescribed oral nutritional supplements, which are multinutrient products containing macronutrients and micronutrients. OBJECTIVE: To assess the effectiveness and cost-effectiveness of oral nutritional supplements (with or without other dietary interventions) in frail older people who are malnourished or at risk of malnutrition. DATA SOURCES: MEDLINE, EMBASE, Cochrane Library, Scopus, CINAHL (Cumulative Index to Nursing and Allied Health Literature) and grey literature were searched from inception to 13 September 2021. REVIEW METHODS: A systematic review and meta-analysis was conducted to evaluate the effectiveness and cost-effectiveness of oral nutritional supplements in frail older people (aged ≥ 65 years) who are malnourished or at risk of malnutrition (defined as undernutrition as per National Institute for Health and Care Excellence guidelines). Meta-analysis and network meta-analysis were undertaken, where feasible, along with a narrative synthesis. A cost-effectiveness review was reported narratively. A de novo model was developed using effectiveness evidence identified in the systematic review to estimate the cost-effectiveness of oral nutritional supplements. RESULTS: Eleven studies (n = 822 participants) were included in the effectiveness review, six of which were fully or partly funded by industry. Meta-analyses suggested positive effects of oral nutritional supplements compared with standard care for energy intake (kcal) (standardised mean difference 1.02, 95% confidence interval 0.15 to 1.88; very low quality evidence) and poor mobility (mean difference 0.03, p < 0.00001, 95% confidence interval 0.02 to 0.04; very low quality evidence) but no evidence of an effect for body weight (mean difference 1.31, 95% confidence interval -0.05 to 2.66; very low quality evidence) and body mass index (mean difference 0.54, 95% confidence interval -0.03 to 1.11; very low quality evidence). Pooled results for other outcomes were statistically non-significant. There was mixed narrative evidence regarding the effect of oral nutritional supplements on quality of life. Network meta-analysis could be conducted only for body weight and grip strength; there was evidence of an effect for oral nutritional supplements compared with standard care for body weight only. Study quality was mixed; the randomisation method was typically poorly reported. One economic evaluation, in a care home setting, was included. This was a well-conducted study showing that oral nutritional supplements could be cost-effective. Cost-effectiveness analysis suggested that oral nutritional supplements may only be cost-effective for people with lower body mass index (< 21 kg/m2) using cheaper oral nutritional supplements products that require minimal staff time to administer. LIMITATIONS: The review scope was narrow in focus as few primary studies used frailty measures (or our proxy criteria). This resulted in only 11 included studies. The small evidence base and varied quality of evidence meant that it was not possible to determine accurate estimates of the effectiveness or cost-effectiveness of oral nutritional supplements. Furthermore, only English-language publications were considered. CONCLUSIONS: Overall, the review found little evidence of oral nutritional supplements having significant effects on reducing malnutrition or its adverse outcomes in frail older adults. FUTURE WORK: Future research should focus on independent, high-quality, adequately powered studies to investigate oral nutritional supplements alongside other nutritional interventions, with longer-term follow-up and detailed analysis of determinants, intervention components and cost-effectiveness. STUDY REGISTRATION: This study is registered as PROSPERO CRD42020170906. 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. 26, No. 51. See the NIHR Journals Library website for further project information.

WHAT WAS THE QUESTION?: Malnutrition, in the form of undernutrition, is very common in frail older people. Dietary advice is recommended (e.g. adding nutrients to meals) for older adults who are malnourished, while powdered or liquid supplements (oral nutritional supplements) can be prescribed to those who are malnourished or at risk of becoming malnourished. In this study, we reviewed previous studies to see if oral nutritional supplements (as a form of dietary support) work at reducing malnutrition in frail older adults and whether or not they are value for money. WHAT DID WE DO?: We searched for studies up to September 2021 on frail older people who were at risk of malnutrition or were malnourished in care homes, hospitals or the community in any country. We included studies that measured malnutrition and the consequences of malnutrition, quality of life, survival, costs and hospitalisations. We assessed the difference in malnutrition between those receiving oral nutritional supplements and those receiving usual care or other dietary (or nutritional) interventions. We also looked at the value for money of oral nutritional supplements. WHAT DID WE FIND?: We found 12 studies (11 studies looking at whether the supplements worked and one study looking at value for money). Most of which were of low quality, and many were funded by industry. Studies often did not report on longer-term effects, or how older people felt about the supplements. There was no clear or strong evidence that oral nutritional supplements worked or were value for money in reducing malnutrition or its consequences (such as the ability to perform everyday tasks). WHAT DOES THIS MEAN?: There is weak evidence for oral nutritional supplements in frail older adults. Future high-quality studies should be independent, assess longer-term effects, and have better reporting on factors that influence the impacts of oral nutritional supplements.

Effectiveness and cost-effectiveness of oral nutritional supplements in frail older people who are malnourished or at risk of malnutrition: a systematic review and meta-analysis.

BACKGROUND: Current management of malnutrition can include prescribed oral nutritional supplements (ONS); however, there is uncertainty whether these supplements are effective in people who are older (≥65 years) and frail. We assessed the effectiveness, cost-effectiveness, and adherence and acceptability of ONS in frail older people who are malnourished or at risk of malnutrition. METHODS: In this systematic review and meta-analysis, five bibliographic databases (MEDLINE, EMBASE, Cochrane Library, Scopus, and CINAHL) and grey literature sources were searched from inception to Sept 13, 2021, to identify studies assessing the effectiveness and cost-effectiveness of ONS (with or without other dietary interventions) in frail older people who are malnourished or at risk of malnutrition. Multiple reviewers independently did study screening, data extraction, and risk of bias assessment. Quality was assessed using version 1.0 of the Cochrane risk of bias tool for randomised controlled trials (RCTs), and the BMJ Drummond checklist was used to assess the quality of the included cost-effectiveness study. A meta-analysis was done for the effectiveness review; for the other reviews, a narrative synthesis approach was used. This systematic review and meta-analysis was registered on PROSPERO, CRD42020170906. FINDINGS: Of 8492 records retrieved and screened, we included 11 RCTs involving 822 participants, six of which were fully or partly funded by industry. For the majority of the outcomes for which meta-analyses were possible (11/12), Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) assessments suggested that the evidence was of very low certainty. Results suggested that ONS might have a slightly positive effect on energy (kcal) intake (standardised mean difference 1·02 [95% CI 0·15 to 1·88]; I2=87%; four studies), protein intake (standardised mean difference 1·67 [-0·03 to 3·37; I2=97%; four studies), and mobility (mean difference 0·03 [0·02 to 0·04]; I2=0%; four studies), compared with standard care. Narrative syntheses suggested that the effect of ONS on quality of life, compared with standard care, was mixed. In the identified studies, there was very little information related to active components, determinants, or acceptability of interventions. One economic evaluation, done in a care home setting, showed that ONS could be cost-effective. INTERPRETATION: We found little evidence of ONS reducing malnutrition or its associated adverse outcomes in older people who are frail. High-quality, non-industry-funded, adequately powered studies reporting on short-term and long-term health outcomes, determinants, and participant characteristics are needed. FUNDING: UK National Institute of Health and Care Research (NIHR) Health Technology Assessment (NIHR128729).

Optimal Surveillance Strategies for Early-Stage Cutaneous Melanoma Post Primary Tumor Excision: An Economic Evaluation.

Background. Consensus on standardized active surveillance or follow-up care by clinicians is lacking leading to considerable variation in practice across countries. An important structural modelling consideration is that self-examination by patients and their partners can detect melanoma recurrence outside of active surveillance regimes. Objectives. To identify candidate melanoma surveillance strategies for American Joint Committee on Cancer (AJCC) stage I disease and compare them with the current recommended practice in a cost-utility analysis framework. Methods. In consultation with UK clinical experts, a microsimulation model was built in TreeAge Pro 2019 R1.0 (Williamstown, MA, USA) to evaluate surveillance strategies for AJCC stage IA and IB melanoma patients separately. The model incorporated patient behaviors such as self-detection and emergency visits to examine suspicious lesions. A National Health Service (NHS) perspective was taken. Model input parameters were taken from the literature and where data were not available, local expert opinion was sought. Probabilistic sensitivity analysis, one-way sensitivity analysis on pertinent parameters and value of information was performed. Results. In the base-case probabilistic sensitivity analysis, less intensive surveillance strategies for AJCC stage IA and IB had lower total lifetime costs than the current National Institute for Health and Care Excellence (NICE) recommended strategy with similar effectiveness in terms of quality-adjusted life years and thereby likely to be cost-effective. Many strategies had similar effectiveness due to the relatively low chance of recurrence and the high rate of self-detection. Sensitivity and scenario analyses did not change these findings. Conclusions. Our model findings suggest that less resource intensive surveillance may be cost-effective compared with the current NICE surveillance guidelines. However, to advocate convincingly for changes, better evidence is required.

The effects of radiofrequency exposure on male fertility and adverse reproductive outcomes: A protocol for two systematic reviews of human observational studies with 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 evaluation by experts in the field, to inform exposure guidelines. A suite of systematic reviews are being undertaken by a network of topic experts and methodologists in order to collect, assess and synthesise data relevant to these guidelines. Here, we present the protocol for the systematic review on the effect of exposure to RF on adverse reproductive outcomes (human observational studies), also referred to as Systematic Review (SR) 3 within the series of systematic reviews currently being commissioned. OBJECTIVES: Following the WHO handbook for guideline development and the COSTER conduct guidelines, we will systematically review the effect of RF-EMF exposure on both male fertility (SR3A) and adverse pregnancy outcomes (SR3B) in human observational studies. Herein we adhere to the PRISMA-P reporting guidelines. DATA SOURCES: We will conduct a broad search for potentially relevant records relevant for both reviews within the following bibliographic databases: MEDLINE; Embase; and EMF Portal. We will also conduct searches of grey literature through relevant databases and organisational websites. RF-EMF experts will also be consulted. We will hand search citation and reference lists of included study records. STUDY ELIGIBILITY CRITERIA: We will include quantitative human observational studies on the effect of RF-EMF exposure: (in SR3A) in adult male participants on infertility, sperm morphology, concentration or total sperm count or motility; and (in SR3B) in preconception adults or pregnant women on preterm birth, small for gestational age (associated with intrauterine growth restriction), miscarriage, stillbirth and congenital anomalies. STUDY APPRAISAL AND SYNTHESIS METHODS: Titles, abstracts and then full texts will be screened in blinded duplicate against eligibility criteria with input from a third reviewer as required. Data extraction from included studies will be completed by two reviewers as will risk of bias assessment using the Office of Health Assessment and Translation (OHAT) tool. If appropriate we will undertake meta-analysis to pool effect measures and explore heterogeneity using sub-group analyses or meta-regression as feasible. We will conduct sensitivity analysis to assess the impact of any assumptions made throughout the review process. The OHAT methodology, based on the GRADE guidelines for evidence assessment, will be used to evaluate the certainty of evidence per outcome and to conclude the level of evidence of a health effect. CONCLUSION: This manuscript details the protocols for two systematic reviews. The aims of publishing details of both protocols are to: pre-specify their scope and methods; reduce the impact of reviewer bias; promote transparency and replicability; and improve the review process. PROSPERO REGISTRATION: CRD42021265401 (SR3A), CRD42021266268 (SR3B).

Optimal surveillance strategies for patients with stage 1 cutaneous melanoma post primary tumour excision: three systematic reviews and an economic model.

BACKGROUND: Malignant melanoma is the fifth most common cancer in the UK, with rates continuing to rise, resulting in considerable burden to patients and the NHS. OBJECTIVES: The objectives were to evaluate the effectiveness and cost-effectiveness of current and alternative follow-up strategies for stage IA and IB melanoma. REVIEW METHODS: Three systematic reviews were conducted. (1) The effectiveness of surveillance strategies. Outcomes were detection of new primaries, recurrences, metastases and survival. Risk of bias was assessed using the Cochrane Collaboration's Risk-of-Bias 2.0 tool. (2) Prediction models to stratify by risk of recurrence, metastases and survival. Model performance was assessed by study-reported measures of discrimination (e.g. D-statistic, Harrel's c-statistic), calibration (e.g. the Hosmer-Lemeshow 'goodness-of-fit' test) or overall performance (e.g. Brier score, R2). Risk of bias was assessed using the Prediction model Risk Of Bias ASsessment Tool (PROBAST). (3) Diagnostic test accuracy of fine-needle biopsy and ultrasonography. Outcomes were detection of new primaries, recurrences, metastases and overall survival. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. Review data and data from elsewhere were used to model the cost-effectiveness of alternative surveillance strategies and the value of further research. RESULTS: (1) The surveillance review included one randomised controlled trial. There was no evidence of a difference in new primary or recurrence detected (risk ratio 0.75, 95% confidence interval 0.43 to 1.31). Risk of bias was considered to be of some concern. Certainty of the evidence was low. (2) Eleven risk prediction models were identified. Discrimination measures were reported for six models, with the area under the operating curve ranging from 0.59 to 0.88. Three models reported calibration measures, with coefficients of ≥ 0.88. Overall performance was reported by two models. In one, the Brier score was slightly better than the American Joint Committee on Cancer scheme score. The other reported an R2 of 0.47 (95% confidence interval 0.45 to 0.49). All studies were judged to have a high risk of bias. (3) The diagnostic test accuracy review identified two studies. One study considered fine-needle biopsy and the other considered ultrasonography. The sensitivity and specificity for fine-needle biopsy were 0.94 (95% confidence interval 0.90 to 0.97) and 0.95 (95% confidence interval 0.90 to 0.97), respectively. For ultrasonography, sensitivity and specificity were 1.00 (95% confidence interval 0.03 to 1.00) and 0.99 (95% confidence interval 0.96 to 0.99), respectively. For the reference standards and flow and timing domains, the risk of bias was rated as being high for both studies. The cost-effectiveness results suggest that, over a lifetime, less intensive surveillance than recommended by the National Institute for Health and Care Excellence might be worthwhile. There was considerable uncertainty. Improving the diagnostic performance of cancer nurse specialists and introducing a risk prediction tool could be promising. Further research on transition probabilities between different stages of melanoma and on improving diagnostic accuracy would be of most value. LIMITATIONS: Overall, few data of limited quality were available, and these related to earlier versions of the American Joint Committee on Cancer staging. Consequently, there was considerable uncertainty in the economic evaluation. CONCLUSIONS: Despite adoption of rigorous methods, too few data are available to justify changes to the National Institute for Health and Care Excellence recommendations on surveillance. However, alternative strategies warrant further research, specifically on improving estimates of incidence, progression of recurrent disease; diagnostic accuracy and health-related quality of life; developing and evaluating risk stratification tools; and understanding patient preferences. STUDY REGISTRATION: This study is registered as PROSPERO CRD42018086784. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol 25, No. 64. See the NIHR Journals Library website for further project information.

Malignant melanoma is the deadliest of skin cancers; in the UK, > 2500 people die from it every year. Initially, the cancer is removed surgically, which cures it for most people, but, for some, the cancer returns. For this reason, after a melanoma is removed, patients are followed up to see if the melanoma reoccurs or if new melanomas have developed. It is felt that early cancer detection improves the chance of future treatment working. A key question is how best to follow up patients after initial melanoma surgery. This study concentrates on the earliest stage of melanoma (American Joint Committee on Cancer stage I), which accounts for more than 7 out of 10 of all melanoma diagnoses. The study also investigates if new ways of follow-up could be at least as good as current practice and a better use of NHS money. We systematically reviewed studies comparing different ways of organising follow-up, and then methods to identify those patients at high risk of developing a further melanoma and how good different tests are at detecting this cancer. We then compared different possible follow-up strategies. For each strategy, we considered its impact on quality and length of life, and how well it used NHS resources. We found little evidence to support a change in how follow-up should be organised currently. There were some ways of organising follow-up that might be better than current care, but further research is needed. We found that new research on whether or not follow-up should be performed by a cancer nurse specialist, rather than a dermatologist or surgeon, would be worthwhile. We also found that more research could be worthwhile on how frequently melanoma recurs and spreads, as well as how accurately a diagnosis of further cancer is made and how to identify those most at risk of further melanoma spread.

Investigating the Effectiveness and Acceptability of Oral Health and Related Health Behaviour Interventions in Adults with Severe and Multiple Disadvantage: Protocol for a Mixed-Methods Systematic Review.

Increasing numbers of people in England experience homelessness, substance use, and repeated offending (known as 'severe and multiple disadvantage'; SMD). Populations experiencing SMD often have extremely poor oral health, which is closely inter-linked with high levels of substance use, smoking, and poor diet. This study aims to undertake an evidence synthesis to identify the effectiveness, resource requirements, and factors influencing the implementation and acceptability of oral health and related health behaviour interventions in adults experiencing SMD. Two systematic reviews will be conducted using mixed-methods. Review 1 will investigate the effectiveness and resource implications of oral health and related health behaviours (substance use, smoking, diet) interventions; Review 2 will investigate factors influencing the implementation of such interventions. The population includes adults (≥18 years) experiencing SMD. Standard review methods in terms of searches, screening, data extraction, and quality appraisal will be conducted. Narrative syntheses will be conducted. If feasible, a meta-analysis will be conducted for Review 1 and a thematic synthesis for Review 2. Evidence from the two reviews will then be synthesised together. Input from people with experience of SMD will be sought throughout to inform the reviews. An initial logic model will be iteratively refined during the review.

Socioeconomic inequalities and adverse pregnancy outcomes in the UK and Republic of Ireland: a systematic review and meta-analysis.

OBJECTIVE: There has been an unprecedented rise in infant mortality associated with deprivation in recent years in the United Kingdom (UK) and Republic of Ireland. A healthy pregnancy can have significant impacts on the life chances of children. The objective of this review was to understand the association between individual-level and household-level measures of socioeconomic status and adverse pregnancy outcomes. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Nine databases were searched (Medline, Embase, Scopus, ASSIA, CINAHL, PsycINFO, BNI, MIDRIS and Google Scholar) for articles published between 1999 and August 2019. Grey literature searches were also assessed. STUDY SELECTION CRITERIA: Studies reporting associations between individual-level or household socioeconomic factors on pregnancy outcomes in the UK or Ireland. RESULTS: Among the 82 353 search results, 53 821 titles were identified and 35 unique studies met the eligibility criteria. Outcomes reported were neonatal, perinatal and maternal mortality, preterm birth, birth weight and mode of delivery. Pooled effect sizes were calculated using random-effects meta-analysis. There were significantly increased odds of women from lower levels of occupation/social classes compared with the highest level having stillbirth (OR 1.40, 95% CI 1.23 to 1.59, I298.62%), neonatal mortality (OR 1.39, 95% CI 1.22 to 1.57, I297.09%), perinatal mortality (OR 1.39, 95% CI 1.23 to 1.57, I298.69%), preterm birth (OR 1.41, 95% CI 1.33 to 1.50, I270.97%) and low birth weight (OR 1.40, 95% CI 1.19 to 1.61, I299.85%). Limitations relate to available data, unmeasured confounders and the small number of studies for some outcomes. CONCLUSIONS: This review identified consistent evidence that lower occupational status, especially manual occupations and unemployment, were significantly associated with increased risk of multiple adverse pregnancy outcomes. Strategies to improve pregnancy outcomes should incorporate approaches that address wider determinants of health to provide women and families with the best chances of having a healthy pregnancy and baby and to decrease pregnancy-related health inequalities in the general population. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42019140893.