Endovascular Thrombectomy with or without Bridging Thrombolysis in Acute Ischemic Stroke: A Cost-Effectiveness Analysis.

BACKGROUND: There is unclear added benefit of intravenous thrombolysis (IVT) with endovascular thrombectomy (EVT). We performed a cost-effectiveness analysis to assess the cost-effectiveness of comparing EVT with IVT versus EVT alone. METHODS: We used a decision tree to examine the short-term costs and outcomes at 90 days after the occurrence of index stroke to compare the cost-effectiveness of EVT alone with EVT plus IVT for patients with stroke. Subsequently, we developed a Markov state transition model to assess the costs and outcomes over 1-year, 5-year, and 20-year time horizons. We estimated total and incremental cost, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio. RESULTS: The average costs per patient were estimated to be $47,304, $49,510, $59,770, and $76,561 for EVT-only strategy and $55,482, $57,751, $68,314, and $85,611 for EVT with IVT over 90 days, 1 year, 5 years, and 20 years, respectively. The cost saving of EVT-only strategy was driven by the avoided medication costs of IVT (ranging from $8,178 to $9,050). The additional IVT led to a slight decrease in QALY estimate during the 90-day time horizon (loss of 0.002 QALY), but a small gain over 1-year and 5-year time horizons (0.011 and 0.0636 QALY). At a willingness-to-pay threshold of $50,000 per QALY gained, the probabilities of EVT only being cost-effective were 100%, 100%, and 99.3% over 90-day, 1-year, and 5-year time horizons. CONCLUSION: Our cost-effectiveness model suggested that EVT only may be cost-effective for patients with acute ischemic stroke secondary to large vessel occlusion.

Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD).

BACKGROUND: Inspiratory muscle training (IMT) aims to improve respiratory muscle strength and endurance. Clinical trials used various training protocols, devices and respiratory measurements to check the effectiveness of this intervention. The current guidelines reported a possible advantage of IMT, particularly in people with respiratory muscle weakness. However, it remains unclear to what extent IMT is clinically beneficial, especially when associated with pulmonary rehabilitation (PR).   OBJECTIVES: To assess the effect of inspiratory muscle training (IMT) on chronic obstructive pulmonary disease (COPD), as a stand-alone intervention and when combined with pulmonary rehabilitation (PR). SEARCH METHODS: We searched the Cochrane Airways trials register, CENTRAL, MEDLINE, Embase, PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL) EBSCO, Physiotherapy Evidence Database (PEDro) ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform on 20 October 2021. We also checked reference lists of all primary studies and review articles. SELECTION CRITERIA: We included randomized controlled trials (RCTs) that compared IMT in combination with PR versus PR alone and IMT versus control/sham. We included different types of IMT irrespective of the mode of delivery. We excluded trials that used resistive devices without controlling the breathing pattern or a training load of less than 30% of maximal inspiratory pressure (PImax), or both. DATA COLLECTION AND ANALYSIS: We used standard methods recommended by Cochrane including assessment of risk of bias with RoB 2. Our primary outcomes were dyspnea, functional exercise capacity and health-related quality of life.  MAIN RESULTS: We included 55 RCTs in this review. Both IMT and PR protocols varied significantly across the trials, especially in training duration, loads, devices, number/ frequency of sessions and the PR programs. Only eight trials were at low risk of bias. PR+IMT versus PR We included 22 trials (1446 participants) in this comparison. Based on a minimal clinically important difference (MCID) of -1 unit, we did not find an improvement in dyspnea assessed with the Borg scale at submaximal exercise capacity (mean difference (MD) 0.19, 95% confidence interval (CI) -0.42 to 0.79; 2 RCTs, 202 participants; moderate-certainty evidence).   We also found no improvement in dyspnea assessed with themodified Medical Research Council dyspnea scale (mMRC) according to an MCID between -0.5 and -1 unit (MD -0.12, 95% CI -0.39 to 0.14; 2 RCTs, 204 participants; very low-certainty evidence).  Pooling evidence for the 6-minute walk distance (6MWD) showed an increase of 5.95 meters (95% CI -5.73 to 17.63; 12 RCTs, 1199 participants; very low-certainty evidence) and failed to reach the MCID of 26 meters. In subgroup analysis, we divided the RCTs according to the training duration and mean baseline PImax. The test for subgroup differences was not significant. Trials at low risk of bias (n = 3) demonstrated a larger effect estimate than the overall. The summary effect of the St George's Respiratory Questionnaire (SGRQ) revealed an overall total score below the MCID of 4 units (MD 0.13, 95% CI -0.93 to 1.20; 7 RCTs, 908 participants; low-certainty evidence).  The summary effect of COPD Assessment Test (CAT) did not show an improvement in the HRQoL (MD 0.13, 95% CI -0.80 to 1.06; 2 RCTs, 657 participants; very low-certainty evidence), according to an MCID of -1.6 units.  Pooling the RCTs that reported PImax showed an increase of 11.46 cmH2O (95% CI 7.42 to 15.50; 17 RCTs, 1329 participants; moderate-certainty evidence) but failed to reach the MCID of 17.2 cmH2O.  In subgroup analysis, we did not find a difference between different training durations and between studies judged with and without respiratory muscle weakness.  One abstract reported some adverse effects that were considered "minor and self-limited". IMT versus control/sham Thirty-seven RCTs with 1021 participants contributed to our second comparison. There was a trend towards an improvement when Borg was calculated at submaximal exercise capacity (MD -0.94, 95% CI -1.36 to -0.51; 6 RCTs, 144 participants; very low-certainty evidence). Only one trial was at a low risk of bias. Eight studies (nine arms) used the Baseline Dyspnea Index - Transition Dyspnea Index (BDI-TDI). Based on an MCID of +1 unit, they showed an improvement only with the 'total score' of the TDI (MD 2.98, 95% CI 2.07 to 3.89; 8 RCTs, 238 participants; very low-certainty evidence). We did not find a difference between studies classified as with and without respiratory muscle weakness. Only one trial was at low risk of bias. Four studies reported the mMRC, revealing a possible improvement in dyspnea in the IMT group (MD -0.59, 95% CI -0.76 to -0.43; 4 RCTs, 150 participants; low-certainty evidence). Two trials were at low risk of bias. Compared to control/sham, the MD in the 6MWD following IMT was 35.71 (95% CI 25.68 to 45.74; 16 RCTs, 501 participants; moderate-certainty evidence). Two studies were at low risk of bias. In subgroup analysis, we did not find a difference between different training durations and between studies judged with and without respiratory muscle weakness.  Six studies reported theSGRQ total score, showing a larger effect in the IMT group (MD -3.85, 95% CI -8.18 to 0.48; 6 RCTs, 182 participants; very low-certainty evidence). The lower limit of the 95% CI exceeded the MCID of -4 units. Only one study was at low risk of bias. There was an improvement in life quality with CAT (MD -2.97, 95% CI -3.85 to -2.10; 2 RCTs, 86 participants; moderate-certainty evidence). One trial was at low risk of bias. Thirty-two RCTs reported PImax, showing an improvement without reaching the MCID (MD 14.57 cmH2O, 95% CI 9.85 to 19.29; 32 RCTs, 916 participants; low-certainty evidence). In subgroup analysis, we did not find a difference between different training durations and between studies judged with and without respiratory muscle weakness.   None of the included RCTs reported adverse events. AUTHORS' CONCLUSIONS: IMT may not improve dyspnea, functional exercise capacity and life quality when associated with PR. However, IMT is likely to improve these outcomes when provided alone. For both interventions, a larger effect in participants with respiratory muscle weakness and with longer training durations is still to be confirmed.

A Framework for the Development of Living Practice Guidelines in Health Care.

BACKGROUND: Living practice guidelines are increasingly being used to ensure that recommendations are responsive to rapidly emerging evidence. OBJECTIVE: To develop a framework that characterizes the processes of development of living practice guidelines in health care. DESIGN: First, 3 background reviews were conducted: a scoping review of methods papers, a review of handbooks of guideline-producing organizations, and an analytic review of selected living practice guidelines. Second, the core team drafted the first version of the framework. Finally, the core team refined the framework through an online survey and online discussions with a multidisciplinary international group of stakeholders. SETTING: International. PARTICIPANTS: Multidisciplinary group of 51 persons who have experience with guidelines. MEASUREMENTS: Not applicable. RESULTS: A major principle of the framework is that the unit of update in a living guideline is the individual recommendation. In addition to providing definitions, the framework addresses several processes. The planning process should address the organization's adoption of the living methodology as well as each specific guideline project. The production process consists of initiation, maintenance, and retirement phases. The reporting should cover the evidence surveillance time stamp, the outcome of reassessment of the body of evidence (when applicable), and the outcome of revisiting a recommendation (when applicable). The dissemination process may necessitate the use of different venues, including one for formal publication. LIMITATION: This study does not provide detailed or practical guidance for how the described concepts would be best implemented. CONCLUSION: The framework will help guideline developers in planning, producing, reporting, and disseminating living guideline projects. It will also help research methodologists study the processes of living guidelines. PRIMARY FUNDING SOURCE: None.

COVID-19 transmission during swimming-related activities: a rapid systematic review.

BACKGROUND: There are uncertainties about mitigating strategies for swimming-related activities in the context of the COVID-19 pandemic. There is an opportunity to learn from the experience of previous re-openings to better plan the future one. Our objectives are to systematically review the evidence on (1) the association between engaging in swimming-related activities and COVID-19 transmission; and (2) the effects of strategies for preventing COVID-19 transmission during swimming-related activities. METHODS: We conducted a rapid systematic review. We searched in the L·OVE (Living OVerview of Evidence) platform for COVID-19. The searches covered the period from the inception date of each database until April 19, 2021. We included non-randomized studies for the review on association of COVID-19 transmission and swimming-related activities. We included guidance documents reporting on the strategies for prevention of COVID-19 transmission during swimming-related activities. We also included studies on the efficacy and safety of the strategies. Teams of two reviewers independently assessed article eligibility. For the guidance documents, a single reviewer assessed the eligibility and a second reviewer verified the judgement. Teams of two reviewers extracted data independently. We summarized the findings of included studies narratively. We synthesized information from guidance documents according to the identified topics and subtopics, and presented them in tabular and narrative formats. RESULTS: We identified three studies providing very low certainty evidence for the association between engaging in swimming-related activities and COVID-19 transmission. The analysis of 50 eligible guidance documents identified 11 topics: ensuring social distancing, ensuring personal hygiene, using personal protective equipment, eating and drinking, maintaining the pool, managing frequently touched surfaces, ventilation of indoor spaces, screening and management of sickness, delivering first aid, raising awareness, and vaccination. One study assessing the efficacy of strategies to prevent COVID-19 transmission did not find an association between compliance with precautionary restrictions and COVID-19 transmission. CONCLUSIONS: There are major gaps in the research evidence of relevance to swimming-related activities in the context of the COVID-19 pandemic. However, the synthesis of the identified strategies from guidance documents can inform public health management strategies for swimming-related activities, particularly in future re-opening plans.

The Policies for the Disclosure of Funding and Conflict of Interest in Surgery Journals: A Cross-Sectional Survey.

BACKGROUND: Industry through its funding of research and through its relationships with study authors can influence the results of research. Most journals have policies for reporting funding and disclosing conflict of interest (COI) to mitigate the influence of industry on research. The objective of this study is to assess the policies of surgery journals for the reporting of funding and the disclosure of COI. METHODS: We described the prevalence and characteristics of funding and COI policies of journals indexed under "Surgery" in the Journal Citation Reports. We extracted data from publicly available information and through simulation of manuscript submission. RESULTS: Of the 186 eligible journals, 171 (92%) had policies for reporting of funding. None of the policies described procedures to deal with non-reporting or underreporting of funding. Of the 186 journals, 183 (99%) had a policy for disclosure of COI. All journals with a COI policy required disclosure of financial interest, while 96 (52%) required the disclosure of non-financial interests. Only 24 (13%) policies described how non-disclosure of COI affects the editorial process, and none described procedures to verify COI disclosure. Of the policies that required disclosing COI, 94 (51%) also required reporting the source of financial COI. CONCLUSIONS: Most journals have policies for reporting of funding and disclosure of financial COI. However, many do not have clear policies for disclosing non-financial COI. Major limitations in the policies include the lack of processes for the verification of disclosed interests and for dealing with underreporting of funding and of COI.

Implementing person-centred outcome measures in palliative care: An exploratory qualitative study using Normalisation Process Theory to understand processes and context.

BACKGROUND: Despite evidence demonstrating the utility of using Person-Centred Outcome Measures within palliative care settings, implementing them into routine practice is challenging. Most research has described barriers to, without explaining the causal mechanisms underpinning, implementation. Implementation theories explain how, why, and in which contexts specific relationships between barriers/enablers might improve implementation effectiveness but have rarely been used in palliative care outcomes research. AIM: To use Normalisation Process Theory to understand and explain the causal mechanisms that underpin successful implementation of Person-Centred Outcome Measures within palliative care. DESIGN: Exploratory qualitative study. Data collected through semi-structured interviews and analysed using a Framework approach. SETTING/PARTICIPANTS: 63 healthcare professionals, across 11 specialist palliative care services, were purposefully sampled by role, experience, seniority, and settings (inpatient, outpatient/day therapy, home-based/community). RESULTS: Seven main themes were developed, representing the causal mechanisms and relationships underpinning successful implementation of outcome measures into routine practice. Themes were: Subjectivity of measures; Frequency and version of Integrated Palliative care Outcome Scale; Training, education, and peer support; Building and sustaining community engagement; Electronic system readiness; The art of communication; Reinforcing use through demonstrating value. CONCLUSIONS: Relationships influencing implementation resided at individual and organisational levels. Addressing these factors is key to driving the implementation of outcome measures into routine practice so that those using palliative care services can benefit from the systematic identification, management, and measurement of their symptoms and concerns. We provide key questions that are essential for those implementing and using outcome measures to consider in order to facilitate the integration of outcome measures into routine palliative care practice.

Maternal Education and Low Birth Weight in Low- and Middle-Income Countries: Systematic Review and Meta-Analysis.

OBJECTIVE: Adverse birth outcomes, including low birth weight (LBW), remain the leading causes of child morbidity and mortality in many low- and middle-income countries (LMICs). We carried out a systematic review and meta-analysis to assess the strength and consistency of the association between maternal education and LBW in LMICs. METHODS: We conducted an electronic search of studies published between 2000 and 2014 in four databases using three MeSH keywords - birth outcomes including LBW; individual-level socioeconomic measures including maternal education; and a list of LMICs. The methodological quality of each eligible study was evaluated following the GRADE approach. A total of 26 studies were entered into meta-analysis. Subgroup analyses were performed to account for heterogeneity in the measurement of exposure and country development level. FINDINGS: The meta-analysis revealed a statistically significant pooled estimate (OR = 0.67; 95% CI = 0.61-0.74) indicating that maternal education is protective against LBW in LMICs. Heterogeneity was found high in subgroup analyses in studies from lower-middle income countries and in those measuring maternal education in academic classes, but drops considerably in studies from low-income countries and those measuring it in number of years of schooling. The quality of the overall body of evidence is moderate due to high observed heterogeneity in some subgroup analyses and the presence of studies with high risk of bias. INTERPRETATION: Higher maternal education associates with a moderate but statistically significant decrease in the risk of delivering a LBW infant in LMICs. Enhancing girls' and women's access to education operates through a number of pathways to improve birth outcomes and reduce LBW in LMICs.

Ventilation Techniques and Risk for Transmission of Coronavirus Disease, Including COVID-19: A Living Systematic Review of Multiple Streams of Evidence.

BACKGROUND: Mechanical ventilation is used to treat respiratory failure in coronavirus disease 2019 (COVID-19). PURPOSE: To review multiple streams of evidence regarding the benefits and harms of ventilation techniques for coronavirus infections, including that causing COVID-19. DATA SOURCES: 21 standard, World Health Organization-specific and COVID-19-specific databases, without language restrictions, until 1 May 2020. STUDY SELECTION: Studies of any design and language comparing different oxygenation approaches in patients with coronavirus infections, including severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS), or with hypoxemic respiratory failure. Animal, mechanistic, laboratory, and preclinical evidence was gathered regarding aerosol dispersion of coronavirus. Studies evaluating risk for virus transmission to health care workers from aerosol-generating procedures (AGPs) were included. DATA EXTRACTION: Independent and duplicate screening, data abstraction, and risk-of-bias assessment (GRADE for certainty of evidence and AMSTAR 2 for included systematic reviews). DATA SYNTHESIS: 123 studies were eligible (45 on COVID-19, 70 on SARS, 8 on MERS), but only 5 studies (1 on COVID-19, 3 on SARS, 1 on MERS) adjusted for important confounders. A study in hospitalized patients with COVID-19 reported slightly higher mortality with noninvasive ventilation (NIV) than with invasive mechanical ventilation (IMV), but 2 opposing studies, 1 in patients with MERS and 1 in patients with SARS, suggest a reduction in mortality with NIV (very-low-certainty evidence). Two studies in patients with SARS report a reduction in mortality with NIV compared with no mechanical ventilation (low-certainty evidence). Two systematic reviews suggest a large reduction in mortality with NIV compared with conventional oxygen therapy. Other included studies suggest increased odds of transmission from AGPs. LIMITATION: Direct studies in COVID-19 are limited and poorly reported. CONCLUSION: Indirect and low-certainty evidence suggests that use of NIV, similar to IMV, probably reduces mortality but may increase the risk for transmission of COVID-19 to health care workers. PRIMARY FUNDING SOURCE: World Health Organization. (PROSPERO: CRD42020178187).

Financial relationships between patient and consumer representatives and the health industry: A systematic review.

BACKGROUND: Patients and consumers are increasingly engaged in health policymaking, research and drug regulation. Having financial relationships with the health industry creates situations of conflicts of interest (COI) and might compromise their meaningful and unbiased participation. OBJECTIVE: To synthesize available evidence on the financial relationships between the health industry and patient and consumer representatives and their organizations. METHODS: We systematically searched MEDLINE and EMBASE. We selected studies and abstracted data in duplicate and independently. We reported on outcomes related to financial relationships of individuals with, and/or funding of organizations by the health industry. RESULTS: We identified a total of 14 510 unique citations, of which 24 reports of 23 studies were eligible. Three studies (13%) addressed the financial relationship of patient and consumer representatives with the health industry. Of these, two examined the proportion of public speakers in drug regulatory processes who have financial relationships; the proportions in the two studies were 25% and 19% respectively. Twenty studies (87%) addressed funding of patient and consumer organizations. The median proportion of organizations that reported funding from the health industry was 62% (IQR: 34%-69%) in questionnaire surveys, and 75% (IQR: 58%-85%) in surveys of their websites. Among organizations for which there was evidence of industry funding, a median proportion of 29% (IQR: 27%-44%) acknowledged on their websites receiving that funding. CONCLUSION: Financial relationships between the health industry and patient and consumer representatives and their organizations are common and may not be disclosed. Stricter regulation on disclosure and management is needed.

The intersections of industry with the health research enterprise.

There is increased awareness of the negative impact of large multinational corporations - the 'industry' - on public health. These corporations have established different types of relationships with a number of actors in the field of health research. This Commentary explores the different types of relationships between the industry and the actors of health research, how they intersect with the different research steps, and how these relationships allow the industry to exert influence. The types of relationships discussed consist of funding of research, direct relationships with the actors of research (namely advocacy groups, funding agencies, experts, professional organisations, regulatory agencies and health practitioners), and the influencing research standards. The potentially influenced research steps either precede the research (i.e. the prioritisation of research question), relate to it directly (i.e. its planning, conduct, reporting, dissemination and evaluation), or build on it (i.e. regulatory approval, integration into guidelines and adoption into practice). In conclusion, the industry has successfully fostered relationships with almost every actor of the health research enterprise and is using these relationships to influence the different steps of health research. The degree of influence the industry is having on health research calls for more work on managing the relationships discussed herein.

NAT1 genotypic and phenotypic contribution to urinary bladder cancer risk: a systematic review and meta-analysis.

N-acetyltransferase 1 (NAT1), a polymorphic Phase II enzyme, plays an essential role in metabolizing heterocyclic and aromatic amines, which are implicated in urinary bladder cancer (BCa). This systematic review investigates a possible association between the different NAT1 genetic polymorphisms and BCa risk. Medline, PubMed, EMBASE, Scopus, Web of Science, OpenGrey, and BASE databases were searched to identify eligible studies. The random-effect model was used to calculate pooled effects estimates. Statistical heterogeneity was tested with Chi-square and I2. Twenty case-control studies, including 5606 cases and 6620 controls, met the inclusion criteria. Pooled odds ratios (OR) analyses showed a statistically significant difference in NAT1*10 versus non-NAT1*10 acetylators in the total sample (OR: 0.87; 95% CI: 0.79-0.96) but was borderline among Caucasians (OR: 0.88 with 95% CI: 0.77-1.01). No statistically significant differences in BCa risk were found for: NAT1*10 versus NAT1*4 wild type (OR: 0.97; 95% CI: 0.78-1.19), NAT1 'Fast' versus 'Normal' acetylators (OR: 1.03; 95% CI: 0.84-1.27), and NAT1 'Slow' versus 'Fast' (OR: 2.32; 95% CI: 0.93-5.84) or 'Slow' versus 'Normal' acetylators (OR: 1.84; 95% CI: 0.92-3.68). When stratifying by smoking status, no statistically significant differences in BCa risk were found for NAT1*10 versus non-NAT1*10 acetylators among the different subgroups. Our study suggests a modest protective role for NAT1*10 and a possible risk contributory role for slow acetylation genotypes in BCa risk. Further research is recommended to confirm these associations.

Implantable cardiac defibrillators for people with non-ischaemic cardiomyopathy.

BACKGROUND: There is evidence that implantable cardioverter-defibrillator (ICD) for primary prevention in people with an ischaemic cardiomyopathy improves survival rate. The evidence supporting this intervention in people with non-ischaemic cardiomyopathy is not as definitive, with the recently published DANISH trial finding no improvement in survival rate. A systematic review of all eligible studies was needed to evaluate the benefits and harms of using ICDs for primary prevention in people with non-ischaemic cardiomyopathy. OBJECTIVES: To evaluate the benefits and harms of using compared to not using ICD for primary prevention in people with non-ischaemic cardiomyopathy receiving optimal medical therapy. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and the Web of Science Core Collection on 10 October 2018. For ongoing or unpublished clinical trials, we searched the US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), and the ISRCTN registry. To identify economic evaluation studies, we conducted a separate search to 31 March 2015 of the NHS Economic Evaluation Database, and from March 2015 to October 2018 on MEDLINE and Embase. SELECTION CRITERIA: We included randomised controlled trials involving adults with chronic non-ischaemic cardiomyopathy due to a left ventricular systolic dysfunction with an ejection fraction of 35% or less (New York Heart Association (NYHA) type I-IV). Participants in the intervention arm should have received ICD in addition to optimal medical therapy, while those in the control arm received optimal medical therapy alone. We included studies with cardiac resynchronisation therapy when it was appropriately balanced in the experimental and control groups. DATA COLLECTION AND ANALYSIS: The primary outcomes were all-cause mortality, cardiovascular mortality, sudden cardiac death, and adverse events associated with the intervention. The secondary outcomes were non-cardiovascular death, health-related quality of life, hospitalisation for heart failure, first ICD-related hospitalisation, and cost. We abstracted the log (hazard ratio) and its variance from trial reports for time-to-event survival data. We extracted the raw data necessary to calculate the risk ratio. We summarised data on quality of life and cost-effectiveness narratively. We assessed the certainty of evidence for all outcomes using GRADE. MAIN RESULTS: We identified six eligible randomised trials with a total of 3128 participants. The use of ICD plus optimal medical therapy versus optimal medical therapy alone decreases the risk of all-cause mortality (hazard ratio (HR) 0.78, 95% confidence interval (CI) 0.66 to 0.92; participants = 3128; studies = 6; high-certainty evidence). An average of 24 patients need to be treated with ICD to prevent one additional death from any cause (number needed to treat for an additional beneficial outcome (NNTB) = 24). Individuals younger than 65 derive more benefit than individuals older than 65 (HR 0.51, 95% CI 0.29 to 0.91; participants = 348; studies = 1) (NNTB = 10). When added to medical therapy, ICDs probably decrease cardiovascular mortality compared to not adding them (risk ratio (RR) 0.75, 95% CI 0.46 to 1.21; participants = 1781; studies = 4; moderate-certainty evidence) (possibility of both plausible benefit and no effect). Implantable cardioverter-defibrillator was also found to decrease sudden cardiac deaths (HR 0.45, 95% CI 0.29 to 0.70; participants = 1677; studies = 3; high-certainty evidence). An average of 25 patients need to be treated with an ICD to prevent one additional sudden cardiac death (NNTB = 25). We found that ICDs probably increase adverse events (possibility of both plausible harm and benefit), but likely have little or no effect on non-cardiovascular mortality (RR 1.17, 95% CI 0.81 to 1.68; participants = 1781; studies = 4; moderate-certainty evidence) (possibility of both plausible benefit and no effect). Finally, using ICD therapy probably has little or no effect on quality of life, however shocks from the device cause a deterioration in quality of life. No study reported the outcome of first ICD-related hospitalisations. AUTHORS' CONCLUSIONS: The use of ICD in addition to medical therapy in people with non-ischaemic cardiomyopathy decreases all-cause mortality and sudden cardiac deaths and probably decreases mortality from cardiovascular causes compared to medical therapy alone. Their use probably increases the risk for adverse events. However, these devices come at a high cost, and shocks from ICDs cause a deterioration in quality of life.

A non-randomised controlled study to assess the effectiveness of a new proactive multidisciplinary care intervention for older people living with frailty.

BACKGROUND: Integrated care may improve outcomes for older people living with frailty. We aimed to assess the effectiveness of a new, anticipatory, multidisciplinary care service in improving the wellbeing and quality of life (QoL) of older people living with severe frailty. METHODS: A community-based non-randomised controlled study. Participants (≥65 years, electronic Frailty Index ≥0.36) received either the new integrated care service plus usual care, or usual care alone. Data collection was at three time points: baseline, 2-4 weeks, and 10-14 weeks. The primary outcome was patient wellbeing (symptoms and other concerns) at 2-4 weeks, measured using the Integrated Palliative care Outcome Scale (IPOS); the secondary outcome was QoL, measured using EQ-5D-5L. To test duration of effect and safety, wellbeing and QoL were also measured at 10-14 weeks. Descriptive statistics were used to characterise and compare intervention and control groups (eligible but had not accessed the new service), with t-test, Chi-Square, or Mann-Whitney U tests (as appropriate) to test differences at each time point. Generalised linear modelling, with propensity score matching, was used for further group comparisons. Data were analysed using STATA v17. RESULTS: 199 intervention and 54 control participants were recruited. At baseline, intervention and control groups were similar in age, gender, ethnicity, living status, and body mass index, but not functional status or area deprivation score. At 2-4 weeks, wellbeing had improved in the intervention group but worsened in the control (median IPOS -5 versus 2, p<0.001). QoL improved in the intervention group but was unchanged in the control (median EQ-5D-5L 0.12, versus 0.00, p<0.001). After adjusting for age, gender, and living status, the intervention group had an average total IPOS score reduction at 2-4 weeks of 6.34 (95% CI: -9.01: -4.26, p<0.05); this improvement was sustained, with an average total IPOS score reduction at 10-14 weeks of 6.36 (95% CI: -8.91:-3.80, p<0.05). After propensity score matching based on functional status/area deprivation, modelling showed similar results, with a reduction in IPOS score at 2-4 weeks in the intervention group of 7.88 (95% CI: -12.80: -2.96, p<0.001). CONCLUSIONS: Our findings suggest that the new, anticipatory, multidisciplinary care service may have improved the overall wellbeing and quality of life of older people living with frailty at 2-4 weeks and the improvement in wellbeing was sustained at three months. ETHICS APPROVAL: NHS Research Ethics Committee 18/YH/0470 and IRAS-250981. TRIAL REGISTRATION: The trial was retrospectively registered at the International Standard Randomised Controlled Trial Number (ISRCTN) registry (registration date: 01/08/2022, registration number: ISRCTN10613839).

Authorship in reports of clinical practice guidelines: A systematic cross-sectional analysis.

BACKGROUND: A transparent and explicit reporting on authors' contributions to the development of clinical practice guidelines and on panelists' characteristics is essential for their credibility and trustworthiness. We did not find published studies on authorship or panel involvement in clinical practice guidelines. OBJECTIVE: To describe the approach to authorship in reports of clinical practice guidelines, and the characteristics of individual authors. METHODS: We conducted a cross-sectional survey of guidelines listed in the National Guideline Clearing House (NGC) in 2016. We abstracted data on the general characteristics of the guidelines, report approach to authorship, and individual authors characteristics. Data abstraction was in duplicate and independent manner using standardised form. Data analyses were both descriptive and regression analyses. RESULTS: Overall, 139 eligible guidelines with published papers were identified. Of these, 48 (35%) included a group authorship statement in the author byline. A third of these guidelines (n = 45; 32%) reported on authors' contributions, while about half of the guidelines (n = 74; 53%) reported who of the authors served as panel members. Around one-fifth of the guidelines (n = 30; 22%) reported group membership (eg, content expert, patient representative) for at least 1 author. Less than one-seventh of the eligible guidelines indicated who selected the panel members (n = 18; 13%), reported the types of panel members (n = 18; 13%) or the selection criteria (n = 12; 9%). Higher journal impact factor was associated with both "reporting of the author contributions" (OR = 1.07) and "the inclusion of a panel membership section in the guideline report" (OR = 1.21). CONCLUSION: Low percentages of clinical practice guidelines report information on important aspects of authorship and characteristics of individual authors. Better reporting of some of these criteria was associated with journal impact factor.

Public health journals' requirements for authors to disclose funding and conflicts of interest: a cross-sectional study.

BACKGROUND: Public health journals need to have clear policies for reporting the funding of studies and authors' personal financial and non-financial conflicts of interest (COI) disclosures. This study aims to assess the policies of public health journals on reporting of study funding and the disclosure of authors' COIs. METHODS: This is a cross-sectional study of "Public, Environmental & Occupational Health" journals. Teams of two researchers abstracted data in duplicate and independently using REDCap software. RESULTS: Of 173 public health journals, 155 (90%) had a policy for reporting study funding information. Out of these, a majority did not require reporting of the phase of the study for which funding was received (88%), nor the types of funding sources (87%). Of the 173 journals, 163 (94%) had a policy requiring disclosure of authors' COI. However, the majority of these journals did not require financial conflicts of interest disclosures relating to institutions (75%) nor to the author's family members (90%) while 56% required the disclosure of at least one form of non-financial COI. CONCLUSIONS: The policies of the majority of public health journals do not require the reporting of important details such as the role of the funder, and non-financial COI. Journals and publishers should consider revising their editorial policies to ensure complete and transparent reporting of funding and COI.

Determinants of poor cognitive function using A-IQCODE among Lebanese older adults: a cross-sectional study.

INTRODUCTION: Dementia characterized by gradual cognitive decline is an increasing public health problem due to population ageing. This study aims at assessing the prevalence and determinants of cognitive decline among Lebanese older adults. METHODS: Secondary analysis of data from a cross-sectional sample of 502 elders from two Lebanese governorates was conducted. Cognitive decline was assessed using the Arabic Version of 16-item Informant Questionnaire on Cognitive Decline for the older adults (A-IQCODE 16). A multivariable logistic regression model assessed the associations of socio-demographic, clinical and behavioral factors with the presence of cognitive decline. RESULTS: Almost one of six Lebanese older adults (14.8%) scored below 3.34. Higher odds of cognitive decline were associated with higher age, being female, having heart disease and suffering from depression. Pack-years of cigarette smoking showed a protective effect and this relationship seems to be only statistically significant among older adults aged more than 75 years. CONCLUSIONS: Screening programs of cardiovascular risk factors and early detection of depression are 'best buy' public health interventions that could prevent cognitive decline among Lebanese older adults. Differential survival bias seems the reasonable explanation for the protective effect of smoking that is not the common finding from the literature.

The reporting of funding in health policy and systems research: a cross-sectional study.

BACKGROUND: Major research-reporting statements, such as PRISMA and CONSORT, require authors to provide information about funding. The objectives of this study were (1) to assess the reporting of funding in health policy and systems research (HPSR) papers and (2) to assess the funding reporting policies of journals publishing on HPSR. METHODS: We conducted two cross-sectional surveys for papers published in 2016 addressing HPSR (both primary studies and systematic reviews) and for journals publishing on HPSR (both journals under the 'Health Policy and Services' (HPS) category in the Web of Science, and non-HPS journals that published on HPSR). Teams of two reviewers selected studies and abstracted data in duplicate and independently. We conducted descriptive analyses and a regression analysis to investigate the association between reporting of funding by papers and the journal's characteristics. RESULTS: We included 400 studies (200 systematic reviews and 200 primary studies) that were published in 198 journals. Approximately one-third (31%) of HPSR papers did not report on funding. Of those that did, only 11% reported on the role of funders (15% of systematic reviews and 7% of primary studies). Of the 198 journals publishing on HPSR, 89% required reporting of the source of funding. Of those that did, about one-third (34%) required reporting of the role of funders. Journals classified under the HPS category (n = 72) were less likely than non-HPS journals that published HPSR studies (n = 142) to require information on the role of funders (15% vs. 32%). We did not find any of the journals' characteristics to be associated with the reporting of funding by papers. CONCLUSIONS: Despite the majority of journals publishing on HPSR requiring the reporting of funding, approximately one-third of HPSR papers did not report on the funding source. Moreover, few journals publishing on HPSR required the reporting of the role of funders, and few HPSR papers reported on that role.

Requirements of health policy and services journals for authors to disclose financial and non-financial conflicts of interest: a cross-sectional study.

BACKGROUND: The requirements of the health policy and services journals for authors to report their financial and non-financial conflicts of interest (COI) are unclear. The present article aims to assess the requirements of health policy and services journals for authors to disclose their financial and non-financial COIs. METHODS: This is a cross-sectional study of journals listed by the Web of Science under the category of 'Health Policy and Services'. We reviewed the 'Instructions for Authors' on the journals' websites and then simulated the submission of a manuscript to obtain any additional relevant information made available during that step. We abstracted data in duplicate and independently using a standardised form. RESULTS: Out of 72 eligible journals, 67 (93%) had a COI policy. A minority of policies described how the disclosed COIs of authors would impact the editorial process (34%). None of the policies had clear-cut criteria for rejection based on the content of the disclosure. Approximately a fifth of policies (21%) explicitly stated that inaccurate or incomplete disclosures might lead to manuscript rejection or retraction. No policy described whether the journal would verify the accuracy or completeness of authors' disclosed COIs. Most journals' policies (93%) required the disclosure of at least one form of financial COI. While the majority asked for specification of source of payment (71%), a minority asked for the amount (18%). Overall, 81% of policies explicitly required disclosure of non-financial COIs. CONCLUSION: A majority of health policy and services journal policies required the disclosure of authors' financial and non-financial COIs, but few required details on disclosed COIs. Health policy journals should provide specific definitions and instructions for disclosing non-financial COIs. A framework providing clear typology and operational definitions of the different types of COIs will facilitate both their disclosure by authors and reviewers and their assessment and management by the editorial team and the readers.