Perceptual Disorders After Stroke: A Scoping Review of Interventions.

Perceptual disorders relating to hearing, smell, somatosensation, taste, touch, and vision commonly impair stroke survivors' ability to interpret sensory information, impacting on their ability to interact with the world. We aimed to identify and summarize the existing evidence for perceptual disorder interventions poststroke and identify evidence gaps. We searched 13 electronic databases including MEDLINE and Embase and Grey literature and performed citation tracking. Two authors independently applied a priori-defined selection criteria; studies involving stroke survivors with perceptual impairments and interventions addressing those impairments were included. We extracted data on study design, population, perceptual disorders, interventions, and outcomes. Data were tabulated and synthesized narratively. Stroke survivors, carers, and clinicians were involved in agreeing definitions and organizing and interpreting data. From 91 869 records, 80 studies were identified (888 adults and 5 children); participant numbers were small (median, 3.5; range, 1-80), with a broad range of stroke types and time points. Primarily focused on vision (34/80, 42.5%) and somatosensation (28/80; 35.0%), included studies were often case reports (36/80; 45.0%) or randomized controlled trials (22/80; 27.5%). Rehabilitation approaches (78/93; 83.9%), primarily aimed to restore function, and were delivered by clinicians (30/78; 38.5%) or technology (28/78; 35.9%; including robotic interventions for somatosensory disorders). Pharmacological (6/93; 6.5%) and noninvasive brain stimulation (7/93; 7.5%) approaches were also evident. Intervention delivery was poorly reported, but most were delivered in hospital settings (56/93; 60.2%). Study outcomes failed to assess the transfer of training to daily life. Interventions for stroke-related perceptual disorders are underresearched, particularly for pediatric populations. Evidence gaps include interventions for disorders of hearing, taste, touch, and smell perception. Future studies must involve key stakeholders and report this fully. Optimization of intervention design, evaluation, and reporting is required, to support the development of effective, acceptable, and implementable interventions. Registration: URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42019160270.

Conservative interventions for treating urinary incontinence in women: an Overview of Cochrane systematic reviews.

BACKGROUND: Urinary incontinence (UI) is the involuntary loss of urine and can be caused by several different conditions. The common types of UI are stress (SUI), urgency (UUI) and mixed (MUI). A wide range of interventions can be delivered to reduce the symptoms of UI in women. Conservative interventions are generally recommended as the first line of treatment. OBJECTIVES: To summarise Cochrane Reviews that assessed the effects of conservative interventions for treating UI in women. METHODS: We searched the Cochrane Library to January 2021 (CDSR; 2021, Issue 1) and included any Cochrane Review that included studies with women aged 18 years or older with a clinical diagnosis of SUI, UUI or MUI, and investigating a conservative intervention aimed at improving or curing UI. We included reviews that compared a conservative intervention with 'control' (which included placebo, no treatment or usual care), another conservative intervention or another active, but non-conservative, intervention. A stakeholder group informed the selection and synthesis of evidence. Two overview authors independently applied the inclusion criteria, extracted data and judged review quality, resolving disagreements through discussion. Primary outcomes of interest were patient-reported cure or improvement and condition-specific quality of life. We judged the risk of bias in included reviews using the ROBIS tool. We judged the certainty of evidence within the reviews based on the GRADE approach. Evidence relating to SUI, UUI or all types of UI combined (AUI) were synthesised separately. The AUI group included evidence relating to participants with MUI, as well as from studies that combined women with different diagnoses (i.e. SUI, UUI and MUI) and studies in which the type of UI was unclear. MAIN RESULTS: We included 29 relevant Cochrane Reviews. Seven focused on physical therapies; five on education, behavioural and lifestyle advice; one on mechanical devices; one on acupuncture and one on yoga. Fourteen focused on non-conservative interventions but had a comparison with a conservative intervention. No reviews synthesised evidence relating to psychological therapies. There were 112 unique trials (including 8975 women) that had primary outcome data included in at least one analysis. Stress urinary incontinence (14 reviews) Conservative intervention versus control: there was moderate or high certainty evidence that pelvic floor muscle training (PFMT), PFMT plus biofeedback and cones were more beneficial than control for curing or improving UI. PFMT and intravaginal devices improved quality of life compared to control. One conservative intervention versus another conservative intervention: for cure and improvement of UI, there was moderate or high certainty evidence that: continence pessary plus PFMT was more beneficial than continence pessary alone; PFMT plus educational intervention was more beneficial than cones; more-intensive PFMT was more beneficial than less-intensive PFMT; and PFMT plus an adherence strategy was more beneficial than PFMT alone. There was no moderate or high certainty evidence for quality of life. Urgency urinary incontinence (five reviews) Conservative intervention versus control: there was moderate to high-certainty evidence demonstrating that PFMT plus feedback, PFMT plus biofeedback, electrical stimulation and bladder training were more beneficial than control for curing or improving UI. Women using electrical stimulation plus PFMT had higher quality of life than women in the control group. One conservative intervention versus another conservative intervention: for cure or improvement, there was moderate certainty evidence that electrical stimulation was more effective than laseropuncture. There was high or moderate certainty evidence that PFMT resulted in higher quality of life than electrical stimulation and electrical stimulation plus PFMT resulted in better cure or improvement and higher quality of life than PFMT alone. All types of urinary incontinence (13 reviews) Conservative intervention versus control: there was moderate to high certainty evidence of better cure or improvement with PFMT, electrical stimulation, weight loss and cones compared to control. There was moderate certainty evidence of improved quality of life with PFMT compared to control. One conservative intervention versus another conservative intervention: there was moderate or high certainty evidence of better cure or improvement for PFMT with bladder training than bladder training alone. Likewise, PFMT with more individual health professional supervision was more effective than less contact/supervision and more-intensive PFMT was more beneficial than less-intensive PFMT. There was moderate certainty evidence that PFMT plus bladder training resulted in higher quality of life than bladder training alone. AUTHORS' CONCLUSIONS: There is high certainty that PFMT is more beneficial than control for all types of UI for outcomes of cure or improvement and quality of life. We are moderately certain that, if PFMT is more intense, more frequent, with individual supervision, with/without combined with behavioural interventions with/without an adherence strategy, effectiveness is improved. We are highly certain that, for cure or improvement, cones are more beneficial than control (but not PFMT) for women with SUI, electrical stimulation is beneficial for women with UUI, and weight loss results in more cure and improvement than control for women with AUI. Most evidence within the included Cochrane Reviews is of low certainty. It is important that future new and updated Cochrane Reviews develop questions that are more clinically useful, avoid multiple overlapping reviews and consult women with UI to further identify outcomes of importance.

Interventions for perceptual disorders following stroke.

BACKGROUND: Perception is the ability to understand information from our senses. It allows us to experience and meaningfully interact with our environment. A stroke may impair perception in up to 70% of stroke survivors, leading to distress, increased dependence on others, and poorer quality of life. Interventions to address perceptual disorders may include assessment and screening, rehabilitation, non-invasive brain stimulation, pharmacological and surgical approaches. OBJECTIVES: To assess the effectiveness of interventions aimed at perceptual disorders after stroke compared to no intervention or control (placebo, standard care, attention control), on measures of performance in activities of daily living.  SEARCH METHODS: We searched the trials registers of the Cochrane Stroke Group, CENTRAL, MEDLINE, Embase, and three other databases to August 2021. We also searched trials and research registers, reference lists of studies, handsearched journals, and contacted authors. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of adult stroke survivors with perceptual disorders. We defined perception as the specific mental functions of recognising and interpreting sensory stimuli and included hearing, taste, touch, smell, somatosensation, and vision. Our definition of perception excluded visual field deficits, neglect/inattention, and pain. DATA COLLECTION AND ANALYSIS: One review author assessed titles, with two review authors independently screening abstracts and full-text articles for eligibility. One review author extracted, appraised, and entered data, which were checked by a second author. We assessed risk of bias (ROB) using the ROB-1 tool, and quality of evidence using GRADE.  A stakeholder group, comprising stroke survivors, carers, and healthcare professionals, was involved in this review update. MAIN RESULTS: We identified 18 eligible RCTs involving 541 participants. The trials addressed touch (three trials, 70 participants), somatosensory (seven trials, 196 participants) and visual perception disorders (seven trials, 225 participants), with one (50 participants) exploring mixed touch-somatosensory disorders. None addressed stroke-related hearing, taste, or smell perception disorders. All but one examined the effectiveness of rehabilitation interventions; the exception evaluated non-invasive brain stimulation. For our main comparison of active intervention versus no treatment or control, one trial reported our primary outcome of performance in activities of daily living (ADL):  Somatosensory disorders: one trial (24 participants) compared an intervention with a control intervention and reported an ADL measure.  Touch perception disorder: no trials measuring ADL compared an intervention with no treatment or with a control intervention.  Visual perception disorders: no trials measuring ADL compared an intervention with no treatment or control.  In addition, six trials reported ADL outcomes in a comparison of active intervention versus active intervention, relating to somatosensation (three trials), touch (one trial) and vision (two trials).   AUTHORS' CONCLUSIONS: Following a detailed, systematic search, we identified limited RCT evidence of the effectiveness of interventions for perceptual disorders following stroke. There is insufficient evidence to support or refute the suggestion that perceptual interventions are effective. More high-quality trials of interventions for perceptual disorders in stroke are needed. They should recruit sufficient participant numbers, include a 'usual care' comparison, and measure longer-term functional outcomes, at time points beyond the initial intervention period. People with impaired perception following a stroke should continue to receive neurorehabilitation according to clinical guidelines.

Exploring eye care pathways, patient priorities and economics in Pakistan: A scoping review and expert consultation study with thematic analysis.

PURPOSE: As the prevalence of eye diseases increases, demand for effective, accessible and equitable eye care grows worldwide. This is especially true in lower and middle-income countries, which have variable levels of infrastructure and economic resources to meet this increased demand. In the present study we aimed to review the literature on eye care in Pakistan comprehensively, with a particular focus on eye care pathways, patient priorities and economics. METHODS: A systematic scoping review was performed to identify literature relating to eye care in Pakistan. Searches of relevant electronic databases and grey literature were carried out. The results were analysed through a mixed methods approach encompassing descriptive numerical summary and thematic analysis. To consolidate results and define priority areas for future study, expert consultation exercises with key stakeholders were conducted using qualitative semi-structured interviews. RESULTS: One hundred and thirty-two papers (published and unpublished) were included in the final review. The majority (n = 93) of studies utilised a quantitative design. Seven interlinked themes were identified: eye care pathways, burden of eye disease, public views on eye-related issues, workforce, barriers to uptake of eye care services, quality of eye care services and economic impact of blindness. Research priorities included investigating the eye care workforce, the quality and efficiency of current eye care services, eye care services available in rural Pakistan and the costs and benefits related to eye care provision and sustaining eye care programmes. CONCLUSIONS: To the best of our knowledge, this is the first review to synthesise evidence from papers across the field relating to eye care in Pakistan. As such, this work provides new insights into the achievements of the national eye health programme, challenges in eye care in Pakistan and priority areas for future research.

Interventions for improving oral health in people after stroke.

BACKGROUND: For people with physical, sensory and cognitive limitations due to stroke, the routine practice of oral health care (OHC) may become a challenge. Evidence-based supported oral care intervention is essential for this patient group. OBJECTIVES: To compare the effectiveness of OHC interventions with usual care or other treatment options for ensuring oral health in people after a stroke. SEARCH METHODS: We searched the Cochrane Stroke Group and Cochrane Oral Health Group trials registers, CENTRAL, MEDLINE, Embase, and six other databases in February 2019. We scanned reference lists from relevant papers and contacted authors and researchers in the field. We handsearched the reference lists of relevant articles and contacted other researchers. There were no language restrictions. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that evaluated one or more interventions designed to improve the cleanliness and health of the mouth, tongue and teeth in people with a stroke who received assisted OHC led by healthcare staff. We included trials with a mixed population provided we could extract the stroke-specific data. The primary outcomes were dental plaque or denture plaque. Secondary outcomes included presence of oral disease, presence of related infection and oral opportunistic pathogens related to OHC and pneumonia, stroke survivor and providers' knowledge and attitudes to OHC, and patient satisfaction and quality of life. DATA COLLECTION AND ANALYSIS: Two review authors independently screened abstracts and full-text articles according to prespecified selection criteria, extracted data and assessed the methodological quality using the Cochrane 'Risk of bias' tool. We sought clarification from investigators when required. Where suitable statistical data were available, we combined the selected outcome data in pooled meta-analyses. We used GRADE to assess the quality of evidence for each outcome. MAIN RESULTS: Fifteen RCTs (22 randomised comparisons) involving 3631 participants with data for 1546 people with stroke met the selection criteria. OHC interventions compared with usual care Seven trials (2865 participants, with data for 903 participants with stroke, 1028 healthcare providers, 94 informal carers) investigated OHC interventions compared with usual care. Multi-component OHC interventions showed no evidence of a difference in the mean score (DMS) of dental plaque one month after the intervention was delivered (DMS -0.66, 95% CI -1.40 to 0.09; 2 trials, 83 participants; I2 = 83%; P = 0.08; very low-quality evidence). Stroke survivors had less plaque on their dentures when staff had access to the multi-component OHC intervention (DMS -1.31, 95% CI -1.96 to -0.66; 1 trial, 38 participants; P < 0.0001; low-quality evidence). There was no evidence of a difference in gingivitis (DMS -0.60, 95% CI -1.66 to 0.45; 2 trials, 83 participants; I2 = 93%; P = 0.26: very low-quality evidence) or denture-induced stomatitis (DMS -0.33, 95% CI -0.92 to 0.26; 1 trial, 38 participants; P = 0.69; low-quality evidence) among participants receiving the multi-component OHC protocol compared with usual care one month after the intervention. There was no difference in the incidence of pneumonia in participants receiving a multi-component OHC intervention (99 participants; 5 incidents of pneumonia) compared with those receiving usual care (105 participants; 1 incident of pneumonia) (OR 4.17, CI 95% 0.82 to 21.11; 1 trial, 204 participants; P = 0.08; low-quality evidence). OHC training for stroke survivors and healthcare providers significantly improved their OHC knowledge at one month after training (SMD 0.70, 95% CI 0.06 to 1.35; 3 trials, 728 participants; I2 = 94%; P = 0.03; very low-quality evidence). Pooled data one month after training also showed evidence of a difference between stroke survivor and providers' oral health attitudes (SMD 0.28, 95% CI 0.01 to 0.54; 3 trials, 728 participants; I2 = 65%; P = 0.06; very low-quality evidence). OHC interventions compared with placebo Three trials (394 participants, with data for 271 participants with stroke) compared an OHC intervention with placebo. There were no data for primary outcomes. There was no evidence of a difference in the incidence of pneumonia in participants receiving an OHC intervention compared with placebo (OR 0.39, CI 95% 0.14 to 1.09; 2 trials, 242 participants; I2 = 42%; P = 0.07; low-quality evidence). However, decontamination gel reduced the incidence of pneumonia among the intervention group compared with placebo gel group (OR 0.20, 95% CI 0.05 to 0.84; 1 trial, 203 participants; P = 0.028). There was no difference in the incidence of pneumonia in participants treated with povidone-iodine compared with a placebo (OR 0.81, 95% CI 0.18 to 3.51; 1 trial, 39 participants; P = 0.77). One OHC intervention compared with another OHC intervention Twelve trials (372 participants with stroke) compared one OHC intervention with another OHC intervention. There was no difference in dental plaque scores between those participants that received an enhanced multi-component OHC intervention compared with conventional OHC interventions at three months (MD -0.04, 95% CI -0.33 to 0.25; 1 trial, 61 participants; P = 0.78; low-quality evidence). There were no data for denture plaque. AUTHORS' CONCLUSIONS: We found low- to very low-quality evidence suggesting that OHC interventions can improve the cleanliness of patient's dentures and stroke survivor and providers' knowledge and attitudes. There is limited low-quality evidence that selective decontamination gel may be more beneficial than placebo at reducing the incidence of pneumonia. Improvements in the cleanliness of a patient's own teeth was limited. We judged the quality of the evidence included within meta-analyses to be low or very low quality, and this limits our confidence in the results. We still lack high-quality evidence of the optimal approach to providing OHC to people after stroke.

Interventions to support the resilience and mental health of frontline health and social care professionals during and after a disease outbreak, epidemic or pandemic: a mixed methods systematic review.

BACKGROUND: Evidence from disease epidemics shows that healthcare workers are at risk of developing short- and long-term mental health problems. The World Health Organization (WHO) has warned about the potential negative impact of the COVID-19 crisis on the mental well-being of health and social care professionals. Symptoms of mental health problems commonly include depression, anxiety, stress, and additional cognitive and social problems; these can impact on function in the workplace. The mental health and resilience (ability to cope with the negative effects of stress) of frontline health and social care professionals ('frontline workers' in this review) could be supported during disease epidemics by workplace interventions, interventions to support basic daily needs, psychological support interventions, pharmacological interventions, or a combination of any or all of these. OBJECTIVES: Objective 1: to assess the effects of interventions aimed at supporting the resilience and mental health of frontline health and social care professionals during and after a disease outbreak, epidemic or pandemic. Objective 2: to identify barriers and facilitators that may impact on the implementation of interventions aimed at supporting the resilience and mental health of frontline health and social care professionals during and after a disease outbreak, epidemic or pandemic. SEARCH METHODS: On 28 May 2020 we searched the Cochrane Database of Systematic Reviews, CENTRAL, MEDLINE, Embase, Web of Science, PsycINFO, CINAHL, Global Index Medicus databases and WHO Institutional Repository for Information Sharing. We also searched ongoing trials registers and Google Scholar. We ran all searches from the year 2002 onwards, with no language restrictions. SELECTION CRITERIA: We included studies in which participants were health and social care professionals working at the front line during infectious disease outbreaks, categorised as epidemics or pandemics by WHO, from 2002 onwards. For objective 1 we included quantitative evidence from randomised trials, non-randomised trials, controlled before-after studies and interrupted time series studies, which investigated the effect of any intervention to support mental health or resilience, compared to no intervention, standard care, placebo or attention control intervention, or other active interventions. For objective 2 we included qualitative evidence from studies that described barriers and facilitators to the implementation of interventions. Outcomes critical to this review were general mental health and resilience. Additional outcomes included psychological symptoms of anxiety, depression or stress; burnout; other mental health disorders; workplace staffing; and adverse events arising from interventions. DATA COLLECTION AND ANALYSIS: Pairs of review authors independently applied selection criteria to abstracts and full papers, with disagreements resolved through discussion. One review author systematically extracted data, cross-checked by a second review author. For objective 1, we assessed risk of bias of studies of effectiveness using the Cochrane 'Risk of bias' tool. For objective 2, we assessed methodological limitations using either the CASP (Critical Appraisal Skills Programme) qualitative study tool, for qualitative studies, or WEIRD (Ways of Evaluating Important and Relevant Data) tool, for descriptive studies. We planned meta-analyses of pairwise comparisons for outcomes if direct evidence were available. Two review authors extracted evidence relating to barriers and facilitators to implementation, organised these around the domains of the Consolidated Framework of Implementation Research, and used the GRADE-CERQual approach to assess confidence in each finding. We planned to produce an overarching synthesis, bringing quantitative and qualitative findings together. MAIN RESULTS: We included 16 studies that reported implementation of an intervention aimed at supporting the resilience or mental health of frontline workers during disease outbreaks (severe acute respiratory syndrome (SARS): 2; Ebola: 9; Middle East respiratory syndrome (MERS): 1; COVID-19: 4). Interventions studied included workplace interventions, such as training, structure and communication (6 studies); psychological support interventions, such as counselling and psychology services (8 studies); and multifaceted interventions (2 studies). Objective 1: a mixed-methods study that incorporated a cluster-randomised trial, investigating the effect of a work-based intervention, provided very low-certainty evidence about the effect of training frontline healthcare workers to deliver psychological first aid on a measure of burnout. Objective 2: we included all 16 studies in our qualitative evidence synthesis; we classified seven as qualitative and nine as descriptive studies. We identified 17 key findings from multiple barriers and facilitators reported in studies. We did not have high confidence in any of the findings; we had moderate confidence in six findings and low to very low confidence in 11 findings. We are moderately confident that the following two factors were barriers to intervention implementation: frontline workers, or the organisations in which they worked, not being fully aware of what they needed to support their mental well-being; and a lack of equipment, staff time or skills needed for an intervention. We are moderately confident that the following three factors were facilitators of intervention implementation: interventions that could be adapted for local needs; having effective communication, both formally and socially; and having positive, safe and supportive learning environments for frontline workers. We are moderately confident that the knowledge or beliefs, or both, that people have about an intervention can act as either barriers or facilitators to implementation of the intervention. AUTHORS' CONCLUSIONS: There is a lack of both quantitative and qualitative evidence from studies carried out during or after disease epidemics and pandemics that can inform the selection of interventions that are beneficial to the resilience and mental health of frontline workers. Alternative sources of evidence (e.g. from other healthcare crises, and general evidence about interventions that support mental well-being) could therefore be used to inform decision making. When selecting interventions aimed at supporting frontline workers' mental health, organisational, social, personal, and psychological factors may all be important. Research to determine the effectiveness of interventions is a high priority. The COVID-19 pandemic provides unique opportunities for robust evaluation of interventions. Future studies must be developed with appropriately rigorous planning, including development, peer review and transparent reporting of research protocols, following guidance and standards for best practice, and with appropriate length of follow-up. Factors that may act as barriers and facilitators to implementation of interventions should be considered during the planning of future research and when selecting interventions to deliver within local settings.

The barriers and facilitators influencing the sustainability of hospital-based interventions: a systematic review.

BACKGROUND: Identifying factors that influence sustained implementation of hospital-based interventions is key to ensuring evidence-based best practice is maintained across the NHS. This study aimed to identify, appraise and synthesise the barriers and facilitators that influenced the delivery of sustained healthcare interventions in a hospital-based setting. METHODS: A systematic review reported in accordance with PRISMA. Eight electronic databases were reviewed in addition to a hand search of Implementation Science journal and reference lists of included articles. Two reviewers were used to screen potential abstracts and full text papers against a selection criteria. Study quality was also independently assessed by two reviewers. Barriers and facilitators were extracted and mapped to a consolidated sustainability framework. RESULTS: Our searching identified 154,757 records. We screened 14,626 abstracts and retrieved 431 full text papers, of which 32 studies met the selection criteria. The majority of studies employed a qualitative design (23/32) and were conducted in the UK (8/32) and the USA (8/32). Interventions or programmes were all multicomponent, with the majority aimed at improving the quality of patient care and/ or safety (22/32). Sustainability was inconsistently reported across 30 studies. Barriers and facilitators were reported in all studies. The key facilitators included a clear accountability of roles and responsibilities (23/32); ensuring the availability of strong leadership and champions advocating the use of the intervention (22/32), and provision of adequate support available at an organisational level (21/32). The most frequently reported barrier to sustainability was inadequate staff resourcing (15/32). Our review also identified the importance of inwards spread and development of the initiative over time, as well as the unpredictability of sustainability and the need for multifaceted approaches. CONCLUSIONS: This review has important implications for practice and research as it increases understanding of the factors that faciliate and hinder intervention sustainability. It also highlights the need for more consistent and complete reporting of sustainability to ensure that lessons learned can be of direct benefit to future implementation of interventions. TRIAL REGISTRATION: The review is registered on PROSPERO ( CRD42017081992 ).

Podiatry interventions to prevent falls in older people: a systematic review and meta-analysis.

BACKGROUND: foot problems are independent risk factors for falls in older people. Podiatrists diagnose and treat a wide range of problems affecting the feet, ankles and lower limbs. However, the effectiveness of podiatry interventions to prevent falls in older people is unknown. This systematic review examined podiatry interventions for falls prevention delivered in the community and in care homes. METHODS: systematic review and meta-analysis. We searched multiple electronic databases with no language restrictions. Randomised or quasi-randomised-controlled trials documenting podiatry interventions in older people (aged 60+) were included. Two reviewers independently applied selection criteria and assessed methodological quality using the Cochrane Risk of Bias tool. TiDieR guidelines guided data extraction and where suitable statistical summary data were available, we combined the selected outcome data in pooled meta-analyses. RESULTS: from 35,857 titles and 5,201 screened abstracts, nine studies involving 6,502 participants (range 40-3,727) met the inclusion criteria. Interventions were single component podiatry (two studies), multifaceted podiatry (three studies), or multifactorial involving other components and referral to podiatry component (four studies). Seven studies were conducted in the community and two in care homes. Quality assessment showed overall low risk for selection bias, but unclear or high risk of detection bias in 4/9 studies. Combining falls rate data showed significant effects for multifaceted podiatry interventions compared to usual care (falls rate ratio 0.77 [95% CI 0.61, 0.99]); and multifactorial interventions including podiatry (falls rate ratio: 0.73 [95% CI 0.54, 0.98]). Single component podiatry interventions demonstrated no significant effects on falls rate. CONCLUSIONS: multifaceted podiatry interventions and multifactorial interventions involving referral to podiatry produce significant reductions in falls rate. The effect of multi-component podiatry interventions and of podiatry within multifactorial interventions in care homes is unknown and requires further trial data. PROSPERO REGISTRATION NUMBER: CRD42017068300.

Interventions for visual field defects in people with stroke.

BACKGROUND: Visual field defects are estimated to affect 20% to 57% of people who have had a stroke. Visual field defects can affect functional ability in activities of daily living (commonly affecting mobility, reading and driving), quality of life, ability to participate in rehabilitation, and depression and anxiety following stroke. There are many interventions for visual field defects, which are proposed to work by restoring the visual field (restitution); compensating for the visual field defect by changing behaviour or activity (compensation); substituting for the visual field defect by using a device or extraneous modification (substitution); or ensuring appropriate diagnosis, referral and treatment prescription through standardised assessment or screening, or both. OBJECTIVES: To determine the effects of interventions for people with visual field defects after stroke. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register, the Cochrane Eyes and Vision Group Trials Register, CENTRAL, MEDLINE, Embase, CINAHL, AMED, PsycINFO, and PDQT Databse, and clinical trials databases, including ClinicalTrials.gov and WHO Clinical Trials Registry, to May 2018. We also searched reference lists and trials registers, handsearched journals and conference proceedings, and contacted experts. SELECTION CRITERIA: Randomised trials in adults after stroke, where the intervention was specifically targeted at improving the visual field defect or improving the ability of the participant to cope with the visual field loss. The primary outcome was functional ability in activities of daily living and secondary outcomes included functional ability in extended activities of daily living, reading ability, visual field measures, balance, falls, depression and anxiety, discharge destination or residence after stroke, quality of life and social isolation, visual scanning, adverse events, and death. DATA COLLECTION AND ANALYSIS: Two review authors independently screened abstracts, extracted data and appraised trials. We undertook an assessment of methodological quality for allocation concealment, blinding of outcome assessors, method of dealing with missing data, and other potential sources of bias. We assessed the quality of evidence for each outcome using the GRADE approach. MAIN RESULTS: Twenty studies (732 randomised participants, with data for 547 participants with stroke) met the inclusion criteria for this review. However, only 10 of these studies compared the effect of an intervention with a placebo, control, or no treatment group, and eight had data which could be included in meta-analyses. Only two of these eight studies presented data relating to our primary outcome of functional abilities in activities of daily living. One study reported evidence relating to adverse events.Three studies (88 participants) compared a restitutive intervention with a control, but data were only available for one study (19 participants). There was very low-quality evidence that visual restitution therapy had no effect on visual field outcomes, and a statistically significant effect on quality of life, but limitations with these data mean that there is insufficient evidence to draw any conclusions about the effectiveness of restitutive interventions as compared to control.Four studies (193 participants) compared the effect of scanning (compensatory) training with a control or placebo intervention. There was low-quality evidence that scanning training was more beneficial than control or placebo on quality of life, measured using the Visual Function Questionnaire (VFQ-25) (two studies, 96 participants, mean difference (MD) 9.36, 95% confidence interval (CI) 3.10 to 15.62). However, there was low or very-low quality evidence of no effect on measures of visual field, extended activities of daily living, reading, and scanning ability. There was low-quality evidence of no significant increase in adverse events in people doing scanning training, as compared to no treatment.Three studies (166 participants) compared a substitutive intervention (a type of prism) with a control. There was low or very-low quality evidence that prisms did not have an effect on measures of activities of daily living, extended activities of daily living, reading, falls, or quality of life, and very low-quality evidence that they may have an effect on scanning ability (one study, 39 participants, MD 9.80, 95% CI 1.91 to 17.69). There was low-quality evidence of an increased odds of an adverse event (primarily headache) in people wearing prisms, as compared to no treatment.One study (39 participants) compared the effect of assessment by an orthoptist to standard care (no assessment) and found very low-quality evidence that there was no effect on measures of activities of daily living.Due to the quality and quantity of evidence, we remain uncertain about the benefits of assessment interventions. AUTHORS' CONCLUSIONS: There is a lack of evidence relating to the effect of interventions on our primary outcome of functional ability in activities of daily living. There is limited low-quality evidence that compensatory scanning training may be more beneficial than placebo or control at improving quality of life, but not other outcomes. There is insufficient evidence to reach any generalised conclusions about the effect of restitutive interventions or substitutive interventions (prisms) as compared to placebo, control, or no treatment. There is low-quality evidence that prisms may cause minor adverse events.

Attention control comparisons with SLT for people with aphasia following stroke: methodological concerns raised following a systematic review.

OBJECTIVE: Attention control comparisons in trials of stroke rehabilitation require care to minimize the risk of comparison choice bias. We compared the similarities and differences in SLT and social support control interventions for people with aphasia. DATA SOURCES: Trial data from the 2016 Cochrane systematic review of SLT for aphasia after stroke Methods: Direct and indirect comparisons between SLT, social support and no therapy controls. We double-data extracted intervention details using the template for intervention description and replication. Standardized mean differences and risk ratios (95% confidence intervals (CIs)) were calculated. RESULTS: Seven trials compared SLT with social support ( n = 447). Interventions were matched in format, frequency, intensity, duration and dose. Procedures and materials were often shared across interventions. Social support providers received specialist training and support. Targeted language rehabilitation was only described in therapy interventions. Higher drop-out ( P = 0.005, odds ratio (OR) 0.51, 95% CI 0.32-0.81) and non-adherence to social support interventions ( P < 0.00001, OR 0.18, 95% CI 0.09-0.37) indicated an imbalance in completion rates increasing the risk of control comparison bias. CONCLUSION: Distinctions between social support and therapy interventions were eroded. Theoretically based language rehabilitation was the remaining difference in therapy interventions. Social support is an important adjunct to formal language rehabilitation. Therapists should continue to enable those close to the person with aphasia to provide tailored communication support, functional language stimulation and opportunities to apply rehabilitation gains. Systematic group differences in completion rates is a design-related risk of bias in outcomes observed.

A systematic review of evidence relating to clinical supervision for nurses, midwives and allied health professionals.

AIM: The aim of this study was to systematically review evidence relating to clinical supervision for nurses, midwives and allied health professionals. BACKGROUND: Since 1902 statutory supervision has been a requirement for UK midwives, but this is due to change. Evidence relating to clinical supervision for nurses and allied health professions could inform a new model of clinical supervision for midwives. DESIGN: A systematic review with a contingent design, comprising a broad map of research relating to clinical supervision and two focussed syntheses answering specific review questions. DATA SOURCES: Electronic databases were searched from 2005 - September 2015, limited to English-language peer-reviewed publications. REVIEW METHODS: Systematic reviews evaluating the effectiveness of clinical supervision were included in Synthesis 1. Primary research studies including a description of a clinical supervision intervention were included in Synthesis 2. Quality of reviews were judged using a risk of bias tool and review results summarized in tables. Data describing the key components of clinical supervision interventions were extracted from studies included in Synthesis 2, categorized using a reporting framework and a narrative account provided. RESULTS: Ten reviews were included in Synthesis 1; these demonstrated an absence of convincing empirical evidence and lack of agreement over the nature of clinical supervision. Nineteen primary studies were included in Synthesis 2; these highlighted a lack of consistency and large variations between delivered interventions. CONCLUSION: Despite insufficient evidence to directly inform the selection and implementation of a framework, the limited available evidence can inform the design of a new model of clinical supervision for UK-based midwives.

Recognizing European cancer nursing: Protocol for a systematic review and meta-analysis of the evidence of effectiveness and value of cancer nursing.

AIM: To identify, appraise and synthesize the available evidence relating to the value and impact of cancer nursing on patient experience and outcomes. BACKGROUND: There is a growing body of literature that recognizes the importance and contribution of cancer nurses, however, a comprehensive review examining how cancer nurses have an impact on care quality, patient outcomes and overall experience of cancer, as well as cost of services across the entire cancer spectrum is lacking. DESIGN: A systematic review and meta-analysis using Cochrane methods. METHODS: We will systematically search 10 electronic databases from 2000, with pre-determined search terms. No language restrictions will be applied. We will include all randomized and controlled before-and-after studies that compare cancer nursing interventions to a standard care or no intervention. Two reviewers will independently assess the eligibility of the studies and appraise methodological quality using the Cochrane Risk of Bias tool. Disagreements will be resolved by discussion and may involve a third reviewer if necessary. Data from included studies will be extracted in accordance with the Template for intervention Description and Replication reporting guidelines. Missing data will be actively sought from all trialists. Data will be synthesized in evidence tables and narrative to answer three key questions. If sufficient data are available, we will perform meta-analyses. DISCUSSION: This review will allow us to systematically assess the impact of cancer nursing on patient care and experience. This evidence will be used to determine implications for clinical practice and used to inform future programme and policy decisions in Europe.

Speech and language therapy for aphasia following stroke.

BACKGROUND: Aphasia is an acquired language impairment following brain damage that affects some or all language modalities: expression and understanding of speech, reading, and writing. Approximately one third of people who have a stroke experience aphasia. OBJECTIVES: To assess the effects of speech and language therapy (SLT) for aphasia following stroke. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (last searched 9 September 2015), CENTRAL (2015, Issue 5) and other Cochrane Library Databases (CDSR, DARE, HTA, to 22 September 2015), MEDLINE (1946 to September 2015), EMBASE (1980 to September 2015), CINAHL (1982 to September 2015), AMED (1985 to September 2015), LLBA (1973 to September 2015), and SpeechBITE (2008 to September 2015). We also searched major trials registers for ongoing trials including ClinicalTrials.gov (to 21 September 2015), the Stroke Trials Registry (to 21 September 2015), Current Controlled Trials (to 22 September 2015), and WHO ICTRP (to 22 September 2015). In an effort to identify further published, unpublished, and ongoing trials we also handsearched the International Journal of Language and Communication Disorders (1969 to 2005) and reference lists of relevant articles, and we contacted academic institutions and other researchers. There were no language restrictions. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing SLT (a formal intervention that aims to improve language and communication abilities, activity and participation) versus no SLT; social support or stimulation (an intervention that provides social support and communication stimulation but does not include targeted therapeutic interventions); or another SLT intervention (differing in duration, intensity, frequency, intervention methodology or theoretical approach). DATA COLLECTION AND ANALYSIS: We independently extracted the data and assessed the quality of included trials. We sought missing data from investigators. MAIN RESULTS: We included 57 RCTs (74 randomised comparisons) involving 3002 participants in this review (some appearing in more than one comparison). Twenty-seven randomised comparisons (1620 participants) assessed SLT versus no SLT; SLT resulted in clinically and statistically significant benefits to patients' functional communication (standardised mean difference (SMD) 0.28, 95% confidence interval (CI) 0.06 to 0.49, P = 0.01), reading, writing, and expressive language, but (based on smaller numbers) benefits were not evident at follow-up. Nine randomised comparisons (447 participants) assessed SLT with social support and stimulation; meta-analyses found no evidence of a difference in functional communication, but more participants withdrew from social support interventions than SLT. Thirty-eight randomised comparisons (1242 participants) assessed two approaches to SLT. Functional communication was significantly better in people with aphasia that received therapy at a high intensity, high dose, or over a long duration compared to those that received therapy at a lower intensity, lower dose, or over a shorter period of time. The benefits of a high intensity or a high dose of SLT were confounded by a significantly higher dropout rate in these intervention groups. Generally, trials randomised small numbers of participants across a range of characteristics (age, time since stroke, and severity profiles), interventions, and outcomes. AUTHORS' CONCLUSIONS: Our review provides evidence of the effectiveness of SLT for people with aphasia following stroke in terms of improved functional communication, reading, writing, and expressive language compared with no therapy. There is some indication that therapy at high intensity, high dose or over a longer period may be beneficial. HIgh-intensity and high dose interventions may not be acceptable to all.

Physical rehabilitation approaches for the recovery of function and mobility following stroke.

BACKGROUND: Various approaches to physical rehabilitation may be used after stroke, and considerable controversy and debate surround the effectiveness of relative approaches. Some physiotherapists base their treatments on a single approach; others use a mixture of components from several different approaches. OBJECTIVES: To determine whether physical rehabilitation approaches are effective in recovery of function and mobility in people with stroke, and to assess if any one physical rehabilitation approach is more effective than any other approach.For the previous versions of this review, the objective was to explore the effect of 'physiotherapy treatment approaches' based on historical classifications of orthopaedic, neurophysiological or motor learning principles, or on a mixture of these treatment principles. For this update of the review, the objective was to explore the effects of approaches that incorporate individual treatment components, categorised as functional task training, musculoskeletal intervention (active), musculoskeletal intervention (passive), neurophysiological intervention, cardiopulmonary intervention, assistive device or modality.In addition, we sought to explore the impact of time after stroke, geographical location of the study, dose of the intervention, provider of the intervention and treatment components included within an intervention. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (last searched December 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 12, 2012), MEDLINE (1966 to December 2012), EMBASE (1980 to December 2012), AMED (1985 to December 2012) and CINAHL (1982 to December 2012). We searched reference lists and contacted experts and researchers who have an interest in stroke rehabilitation. SELECTION CRITERIA: Randomised controlled trials (RCTs) of physical rehabilitation approaches aimed at promoting the recovery of function or mobility in adult participants with a clinical diagnosis of stroke. Outcomes included measures of independence in activities of daily living (ADL), motor function, balance, gait velocity and length of stay. We included trials comparing physical rehabilitation approaches versus no treatment, usual care or attention control and those comparing different physical rehabilitation approaches. DATA COLLECTION AND ANALYSIS: Two review authors independently categorised identified trials according to the selection criteria, documented their methodological quality and extracted the data. MAIN RESULTS: We included a total of 96 studies (10,401 participants) in this review. More than half of the studies (50/96) were carried out in China. Generally the studies were heterogeneous, and many were poorly reported.Physical rehabilitation was found to have a beneficial effect, as compared with no treatment, on functional recovery after stroke (27 studies, 3423 participants; standardised mean difference (SMD) 0.78, 95% confidence interval (CI) 0.58 to 0.97, for Independence in ADL scales), and this effect was noted to persist beyond the length of the intervention period (nine studies, 540 participants; SMD 0.58, 95% CI 0.11 to 1.04). Subgroup analysis revealed a significant difference based on dose of intervention (P value < 0.0001, for independence in ADL), indicating that a dose of 30 to 60 minutes per day delivered five to seven days per week is effective. This evidence principally arises from studies carried out in China. Subgroup analyses also suggest significant benefit associated with a shorter time since stroke (P value 0.003, for independence in ADL).We found physical rehabilitation to be more effective than usual care or attention control in improving motor function (12 studies, 887 participants; SMD 0.37, 95% CI 0.20 to 0.55), balance (five studies, 246 participants; SMD 0.31, 95% CI 0.05 to 0.56) and gait velocity (14 studies, 1126 participants; SMD 0.46, 95% CI 0.32 to 0.60). Subgroup analysis demonstrated a significant difference based on dose of intervention (P value 0.02 for motor function), indicating that a dose of 30 to 60 minutes delivered five to seven days a week provides significant benefit. Subgroup analyses also suggest significant benefit associated with a shorter time since stroke (P value 0.05, for independence in ADL).No one physical rehabilitation approach was more (or less) effective than any other approach in improving independence in ADL (eight studies, 491 participants; test for subgroup differences: P value 0.71) or motor function (nine studies, 546 participants; test for subgroup differences: P value 0.41). These findings are supported by subgroup analyses carried out for comparisons of intervention versus no treatment or usual care, which identified no significant effects of different treatment components or categories of interventions. AUTHORS' CONCLUSIONS: Physical rehabilitation, comprising a selection of components from different approaches, is effective for recovery of function and mobility after stroke. Evidence related to dose of physical therapy is limited by substantial heterogeneity and does not support robust conclusions. No one approach to physical rehabilitation is any more (or less) effective in promoting recovery of function and mobility after stroke. Therefore, evidence indicates that physical rehabilitation should not be limited to compartmentalised, named approaches, but rather should comprise clearly defined, well-described, evidenced-based physical treatments, regardless of historical or philosophical origin.

Strategies used for childhood chronic functional constipation: the SUCCESS evidence synthesis.

Background: Up to 30% of children have constipation at some stage in their life. Although often short-lived, in one-third of children it progresses to chronic functional constipation, potentially with overflow incontinence. Optimal management strategies remain unclear. Objective: To determine the most effective interventions, and combinations and sequences of interventions, for childhood chronic functional constipation, and understand how they can best be implemented. Methods: Key stakeholders, comprising two parents of children with chronic functional constipation, two adults who experienced childhood chronic functional constipation and four health professional/continence experts, contributed throughout the research. We conducted pragmatic mixed-method reviews. For all reviews, included studies focused on any interventions/strategies, delivered in any setting, to improve any outcomes in children (0-18 years) with a clinical diagnosis of chronic functional constipation (excluding studies of diagnosis/assessment) included. Dual reviewers applied inclusion criteria and assessed risk of bias. One reviewer extracted data, checked by a second reviewer. Scoping review: We systematically searched electronic databases (including Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature) (January 2011 to March 2020) and grey literature, including studies (any design) reporting any intervention/strategy. Data were coded, tabulated and mapped. Research quality was not evaluated. Systematic reviews of the evidence of effectiveness: For each different intervention, we included existing systematic reviews judged to be low risk of bias (using the Risk of Bias Assessment Tool for Systematic Reviews), updating any meta-analyses with new randomised controlled trials. Where there was no existing low risk of bias systematic reviews, we included randomised controlled trials and other primary studies. The risk of bias was judged using design-specific tools. Evidence was synthesised narratively, and a process of considered judgement was used to judge certainty in the evidence as high, moderate, low, very low or insufficient evidence. Economic synthesis: Included studies (any design, English-language) detailed intervention-related costs. Studies were categorised as cost-consequence, cost-effectiveness, cost-utility or cost-benefit, and reporting quality evaluated using the consensus health economic criteria checklist. Systematic review of implementation factors: Included studies reported data relating to implementation barriers or facilitators. Using a best-fit framework synthesis approach, factors were synthesised around the consolidated framework for implementation research domains. Results: Stakeholders prioritised outcomes, developed a model which informed evidence synthesis and identified evidence gaps. Scoping review: 651 studies, including 190 randomised controlled trials and 236 primary studies, conservatively reported 48 interventions/intervention combinations. Effectiveness systematic reviews: studies explored service delivery models (n = 15); interventions delivered by families/carers (n = 32), wider children's workforce (n = 21), continence teams (n = 31) and specialist consultant-led teams (n = 42); complementary therapies (n = 15); and psychosocial interventions (n = 4). One intervention (probiotics) had moderate-quality evidence; all others had low to very-low-quality evidence. Thirty-one studies reported evidence relating to cost or resource use; data were insufficient to support generalisable conclusions. One hundred and six studies described implementation barriers and facilitators. Conclusions: Management of childhood chronic functional constipation is complex. The available evidence remains limited, with small, poorly conducted and reported studies. Many evidence gaps were identified. Treatment recommendations within current clinical guidelines remain largely unchanged, but there is a need for research to move away from considering effectiveness of single interventions. Clinical care and future studies must consider the individual characteristics of children. Study registration: This study is registered as PROSPERO CRD42019159008. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 128470) and is published in full in Health Technology Assessment; Vol. 28, No. 5. See the NIHR Funding and Awards website for further award information.

Between 5% and 30% of children experience constipation at some stage. In one-third of these children, this progresses to chronic functional constipation. Chronic functional constipation affects more children with additional needs. We aimed to find and bring together published information about treatments for chronic functional constipation, to help establish best treatments and treatment combinations. We did not cover assessment or diagnosis of chronic functional constipation. This project was guided by a 'stakeholder group', including parents of children with constipation, people who experienced constipation as children, and healthcare professionals/continence experts. We carried out a 'scoping review' and a series of 'systematic reviews'. Our 'scoping review' provides an overall picture of research about treatments, with 651 studies describing 48 treatments. This helps identify important evidence gaps. 'Systematic reviews' are robust methods of bringing together and interpreting research evidence. Our stakeholder group decided to structure our systematic reviews to reflect who delivered the interventions. We brought together evidence about how well treatments worked when delivered by families/carers (32 studies), the wider children's workforce (e.g. general practitioner, health visitor) (21 studies), continence teams (31 studies) or specialist consultant-led teams (42 studies). We also considered complementary therapies (15 studies) and behavioural strategies (4 studies). Care is affected by what is done and how it is done. We brought together evidence about different models of delivering care (15 studies), barriers and facilitators to implementation of treatments (106 studies) and costs (31 studies). Quality of evidence was mainly low to very low. Despite numerous studies, there was often insufficient information to support generalisable conclusions. Our findings generally agreed with current clinical guidelines. Management of childhood chronic functional constipation should be child-centred, multifaceted and adapted according to the individual child, their needs, the situation in which they live and the health-care setting in which they are looked after. Research is needed to address our identified evidence gaps.

Use of existing systematic reviews for the development of evidence-based vaccination recommendations: Guidance from the SYSVAC expert panel.

National immunization technical advisory groups (NITAGs) develop immunization-related recommendations and assist policy-makers in making evidence informed decisions. Systematic reviews (SRs) that summarize the available evidence on a specific topic are a valuable source of evidence in the development of such recommendations. However, conducting SRs requires significant human, time, and financial resources, which many NITAGs lack. Given that SRs already exist for many immunization-related topics, and to prevent duplication and overlap of reviews, a more practical approach may be for NITAGs to use existing SRs. Nevertheless, it can be challenging to identify relevant SRs, to select one SR from among multiple SRs, or to critically assess and effectively use them. To support NITAGs, the London School of Hygiene and Tropical Medicine, Robert Koch Institute and collaborators developed the SYSVAC project, which consists of an online registry of systematic reviews on immunization-related topics and an e-learning course, that supports the use of them (both freely accessible at https://www.nitag-resource.org/sysvac-systematic-reviews). Drawing from the e-learning course and recommendations from an expert panel, this paper outlines methods for using existing systematic reviews when making immunization-related recommendations. With specific examples and reference to the SYSVAC registry and other resources, it offers guidance on locating existing systematic reviews; assessing their relevance to a research question, up-to-dateness, and methodological quality and/or risk of bias; and considering the transferability and applicability of their findings to other populations or settings.

Protocol for the development of guidance for collaborator and partner engagement in health care evidence syntheses.

BACKGROUND: Involving collaborators and partners in research may increase relevance and uptake, while reducing health and social inequities. Collaborators and partners include people and groups interested in health research: health care providers, patients and caregivers, payers of health research, payers of health services, publishers, policymakers, researchers, product makers, program managers, and the public. Evidence syntheses inform decisions about health care services, treatments, and practice, which ultimately affect health outcomes. Our objectives are to: A. Identify, map, and synthesize qualitative and quantitative findings related to engagement in evidence syntheses B. Explore how engagement in evidence synthesis promotes health equity C. Develop equity-oriented guidance on methods for conducting, evaluating, and reporting engagement in evidence syntheses METHODS: Our diverse, international team will develop guidance for engagement with collaborators and partners throughout multiple sequential steps using an integrated knowledge translation approach: 1. Reviews. We will co-produce 1 scoping review, 3 systematic reviews and 1 evidence map focusing on (a) methods, (b) barriers and facilitators, (c) conflict of interest considerations, (d) impacts, and (e) equity considerations of engagement in evidence synthesis. 2. Methods study, interviews, and survey. We will contextualise the findings of step 1 by assessing a sample of evidence syntheses reporting on engagement with collaborators and partners and through conducting interviews with collaborators and partners who have been involved in producing evidence syntheses. We will use these findings to develop draft guidance checklists and will assess agreement with each item through an international survey. 3. CONSENSUS: The guidance checklists will be co-produced and finalised at a consensus meeting with collaborators and partners. 4. DISSEMINATION: We will develop a dissemination plan with our collaborators and partners and work collaboratively to improve adoption of our guidance by key organizations. CONCLUSION: Our international team will develop guidance for collaborator and partner engagement in health care evidence syntheses. Incorporating partnership values and expectations may result in better uptake, potentially reducing health inequities.

PROTOCOL: Conflict of interest issues when engaging stakeholders in health and healthcare guideline development: a systematic review.

This is the protocol for a Campbell systematic review. The overall objective of this study is to gather and summarize the existing literature on conflict of interest issues when engaging stakeholders in guideline development.

PROTOCOL: Barriers and facilitators to stakeholder engagement in health guideline development: A qualitative evidence synthesis.

Background: There is a need for the development of comprehensive, global, evidence-based guidance for stakeholder engagement in guideline development. Stakeholders are any individual or group who is responsible for or affected by health- and healthcare-related decisions. This includes patients, the public, providers of health care and policymakers for example. As part of the guidance development process, Multi-Stakeholder Engagement (MuSE) Consortium set out to conduct four concurrent systematic reviews to summarise the evidence on: (1) existing guidance for stakeholder engagement in guideline development, (2) barriers and facilitators to stakeholder engagement in guideline development, (3) managing conflicts of interest in stakeholder engagement in guideline development and (4) measuring the impact of stakeholder engagement in guideline development. This protocol addresses the second systematic review in the series. Objectives: The objective of this review is to identify and synthesise the existing evidence on barriers and facilitators to stakeholder engagement in health guideline development. We will address this objective through two research questions: (1) What are the barriers to multi-stakeholder engagement in health guideline development across any of the 18 steps of the GIN-McMaster checklist? (2) What are the facilitators to multi-stakeholder engagement in health guideline development across any of the 18 steps of the GIN-McMaster checklist? Search Methods: A comprehensive search strategy will be developed and peer-reviewed in consultation with a medical librarian. We will search the following databases: MEDLINE, Cumulative Index to Nursing & Allied Health Literature (CINAHL), EMBASE, PsycInfo, Scopus, and Sociological Abstracts. To identify grey literature, we will search the websites of agencies who actively engage stakeholder groups such as the AHRQ, Canadian Institutes of Health Research (CIHR) Strategy for Patient-Oriented Research (SPOR), INVOLVE, the National Institute for Health and Care Excellence (NICE) and the PCORI. We will also search the websites of guideline-producing agencies, such as the American Academy of Pediatrics, Australia's National Health Medical Research Council (NHMRC) and the WHO. We will invite members of the team to suggest grey literature sources and we plan to broaden the search by soliciting suggestions via social media, such as Twitter. Selection Criteria: We will include empirical qualitative and mixed-method primary research studies which qualitatively report on the barriers or facilitators to stakeholder engagement in health guideline development. The population of interest is stakeholders in health guideline development. Building on previous work, we have identified 13 types of stakeholders whose input can enhance the relevance and uptake of guidelines: Patients, caregivers and patient advocates; Public; Providers of health care; Payers of health services; Payers of research; Policy makers; Program managers; Product makers; Purchasers; Principal investigators and their research teams; and Peer-review editors/publishers. Eligible studies must describe stakeholder engagement at any of the following steps of the GIN-McMaster Checklist for Guideline Development. Data Collection and Analysis: All identified citations from electronic databases will be imported into Covidence software for screening and selection. Documents identified through our grey literature search will be managed and screened using an Excel spreadsheet. A two-part study selection process will be used for all identified citations: (1) a title and abstract review and (2) full-text review. At each stage, teams of two review authors will independently assess all potential studies in duplicate using a priori inclusion and exclusion criteria. Data will be extracted by two review authors independently and in duplicate according to a standardised data extraction form. Main Results: The results of this review will be used to inform the development of guidance for multi-stakeholder engagement in guideline development and implementation. This guidance will be official GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group guidance. The GRADE system is internationally recognised as a standard for guideline development. The findings of this review will assist organisations who develop healthcare, public health and health policy guidelines, such as the World Health Organization, to involve multiple stakeholders in the guideline development process to ensure the development of relevant, high quality and transparent guidelines.