Anti-obesity pharmacological agents for polycystic ovary syndrome: A systematic review and meta-analysis to inform the 2023 international evidence-based guideline.

This systematic review and meta-analysis evaluated the efficacy of anti-obesity agents for hormonal, reproductive, metabolic, and psychological outcomes in polycystic ovary syndrome (PCOS) to inform the 2023 update of the International Evidence-based Guideline on PCOS. We searched Medline, EMBASE, PsycInfo, and CINAHL until July 2022 with a 10-year limit to focus on newer agents. Eleven trials (545 and 451 participants in intervention and control arms respectively, 12 comparisons) were included. On descriptive analyses, most agents improved anthropometric outcomes; liraglutide, semaglutide and orlistat appeared superior to placebo for anthropometric outcomes. Meta-analyses were possible for two comparisons (exenatide vs. metformin and orlistat + combined oral contraceptive pill [COCP] vs. COCP alone). On meta-analysis, no differences were identified between exenatide versus metformin for anthropometric, biochemical hyperandrogenism, and metabolic outcomes, other than lower fasting blood glucose more with metformin than exenatide (MD: 0.10 mmol/L, CI 0.02-0.17, I2 = 18%, 2 trials). Orlistat + COCP did not improve metabolic outcomes compared with COCP alone (fasting insulin MD: -8.65 pmol/L, -33.55 to 16.26, I2 = 67%, 2 trials). Published data examining the effects of anti-obesity agents in women with PCOS are very limited. The role of these agents in PCOS should be a high priority for future research.

How effective are interventions in optimizing workplace mental health and well-being? A scoping review of reviews and evidence map.

OBJECTIVES: Mental well-being is critical to quality of life. Workplace mental well-being is crucial to ensure employee health, satisfaction, and performance. Mental ill-health is a global challenge, costing workplaces $17 billion per year. Workplaces have realized the need for investment in interventions to promote mental health and well-being in their workforce. However, given their limited resources, workplace personnel responsible for program implementation need evidence-based guidance on which interventions influence which outcomes. METHODS: This study employed a scoping review methodology in order to produce an evidence map and includes reviews of workplace mental well-being interventions. The search strategy focused on peer-reviewed articles with the primary aim of investigating workplace mental health interventions. Reviews were assessed for quality using AMSTAR 2. The evidence map includes interventions (rows) and outcomes (columns), with the relative size of the reviews underpinning each intersection represented by circles and the direction of evidence represented by color. RESULTS: Eighty reviews were deemed eligible from 4795 citations. The resulting evidence map includes 17 intervention types designed to influence 12 outcomes. Interventions with the highest quality evidence were mindfulness, education and information provision, and individual psychological therapies. The most common outcomes were burnout / stress reduction and mental well-being. Interventions tended to focus on individual level factors rather than organizational or system-level factors. CONCLUSION: The evidence-base for workplace mental health interventions is broad and extensive. There is an apparent knowledge-to-practice gap, presenting challenges to implementing workplace mental health programs (ie, what interventions have the highest quality evidence). This study aims to fill the gap by providing an interactive evidence-map. Future research should look to fill the gaps within the map including the lack of organization and system level factors and especially economic evaluations.

Feasibility of national living guideline methods: The Australian Stroke Guidelines.

OBJECTIVE: Maintaining clinical guideline currency has been one challenge to traditional guideline development. This paper describes the methods used to maintain a large national guideline for stroke management. STUDY DESIGN AND SETTING: The Australian Stroke Clinical Guidelines are developed to meet Australian National Health and Medical Research Council (NHMRC) standards. Monthly surveillance is conducted for new systematic reviews and randomised controlled studies. Included studies undergo data extraction followed by preparation of updated evidence-to-decision frameworks which are used to inform updates, or development of new recommendations. Small writing groups made up of clinical experts and those with lived experience review and agree on changes, which are finally reviewed by a multidisciplinary Guidelines Steering Group. Draft changes are developed and published using the online MAGICapp platform, with dissemination and promotion via traditional methods as well as social media. RESULTS: Each month approximately 350 abstracts are considered, covering 96 clinical topics and taking on average 16 h to review. There have been four major guideline updates covering 34 new and updated recommendations. CONCLUSION: It is feasible to use 'living' methods to maintain the Australian Clinical Guidelines for Stroke Management. Further work is now needed to understand the impact of living guidelines.

Tools to facilitate communication during physician-patient consultations in cancer care: An overview of systematic reviews.

Tools have been developed to facilitate communication and support information exchange between people diagnosed with cancer and their physicians. Patient-reported outcome measures, question prompt lists, patient-held records, tape recordings of consultations, decision aids, and survivorship care plans have all been promoted as potential tools, and there is extensive literature exploring their impact on patient outcomes. Eleven systematic reviews of studies evaluating tools to facilitate patient-physician communication were reviewed and summarized in this overview of systematic reviews. Across the systematic reviews, 87 publications reported on 84 primary studies involving 15,381 participants. Routine use of patient-reported outcome measures and feedback of results to clinicians can improve pain management, physician-patient communication, and symptom detection and control; increase utilization of supportive care; and increase patient involvement in care. Question prompt lists can increase the number of questions asked by patients without increasing consultation length and may encourage them to reflect and plan questions before the consultation. There is limited benefit in audio recording consultations or using patient-held records during consultations. Physicians should be supported by adequately resourced health services to respond effectively to the range of clinical and broader patient needs identified through the routine use of tools to facilitate communication.

The currency, completeness and quality of systematic reviews of acute management of moderate to severe traumatic brain injury: A comprehensive evidence map.

OBJECTIVE: To appraise the currency, completeness and quality of evidence from systematic reviews (SRs) of acute management of moderate to severe traumatic brain injury (TBI). METHODS: We conducted comprehensive searches to March 2016 for published, English-language SRs and RCTs of acute management of moderate to severe TBI. Systematic reviews and RCTs were grouped under 12 broad intervention categories. For each review, we mapped the included and non-included RCTs, noting the reasons why RCTs were omitted. An SR was judged as 'current' when it included the most recently published RCT we found on their topic, and 'complete' when it included every RCT we found that met its inclusion criteria, taking account of when the review was conducted. Quality was assessed using the AMSTAR checklist (trichotomised into low, moderate and high quality). FINDINGS: We included 85 SRs and 213 RCTs examining the effectiveness of treatments for acute management of moderate to severe TBI. The most frequently reviewed interventions were hypothermia (n = 17, 14.2%), hypertonic saline and/or mannitol (n = 9, 7.5%) and surgery (n = 8, 6.7%). Of the 80 single-intervention SRs, approximately half (n = 44, 55%) were judged as current and two-thirds (n = 52, 65.0%) as complete. When considering only the most recently published review on each intervention (n = 25), currency increased to 72.0% (n = 18). Less than half of the 85 SRs were judged as high quality (n = 38, 44.7%), and nearly 20% were low quality (n = 16, 18.8%). Only 16 (20.0%) of the single-intervention reviews (and none of the five multi-intervention reviews) were judged as current, complete and high-quality. These included reviews of red blood cell transfusion, hypothermia, management guided by intracranial pressure, pharmacological agents (various) and prehospital intubation. Over three-quarters (n = 167, 78.4%) of the 213 RCTs were included in one or more SR. Of the remainder, 17 (8.0%) RCTs post-dated or were out of scope of existing SRs, and 29 (13.6%) were on interventions that have not been assessed in SRs. CONCLUSION: A substantial number of SRs in acute management of moderate to severe TBI lack currency, completeness and quality. We have identified both potential evidence gaps and also substantial research waste. Novel review methods, such as Living Systematic Reviews, may ameliorate these shortcomings and enhance utility and reliability of the evidence underpinning clinical care.

Interventions for managing skeletal muscle spasticity following traumatic brain injury.

BACKGROUND: Skeletal muscle spasticity is a major physical complication resulting from traumatic brain injury (TBI), which can lead to muscle contracture, joint stiffness, reduced range of movement, broken skin and pain. Treatments for spasticity include a range of pharmacological and non-pharmacological interventions, often used in combination. Management of spasticity following TBI varies from other clinical populations because of the added complexity of behavioural and cognitive issues associated with TBI. OBJECTIVES: To assess the effects of interventions for managing skeletal muscle spasticity in people with TBI. SEARCH METHODS: In June 2017, we searched key databases including the Cochrane Injuries Group Specialised Register, CENTRAL, MEDLINE (Ovid), Embase (Ovid) and others, in addition to clinical trials registries and the reference lists of included studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and cross-over RCTs evaluating any intervention for the management of spasticity in TBI. Only studies where at least 50% of participants had a TBI (or for whom separate data for participants with TBI were available) were included. The primary outcomes were spasticity and adverse effects. Secondary outcome measures were classified according to the World Health Organization International Classification of Functioning, Disability and Health including body functions (sensory, pain, neuromusculoskeletal and movement-related functions) and activities and participation (general tasks and demands; mobility; self-care; domestic life; major life areas; community, social and civic life). DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Data were synthesised narratively; meta-analysis was precluded due to the paucity and heterogeneity of data. MAIN RESULTS: We included nine studies in this review which involved 134 participants with TBI. Only five studies reported between-group differences, yielding outcome data for 105 participants with TBI. These five studies assessed the effects of a range of pharmacological (baclofen, botulinum toxin A) and non-pharmacological (casting, physiotherapy, splints, tilt table standing and electrical stimulation) interventions, often in combination. The studies which tested the effect of baclofen and tizanidine did not report their results adequately. Where outcome data were available, spasticity and adverse events were reported, in addition to some secondary outcome measures.Of the five studies with results, three were funded by governments, charities or health services and two were funded by a pharmaceutical or medical technology company. The four studies without useable results were funded by pharmaceutical or medical technology companies.It was difficult to draw conclusions about the effectiveness of these interventions due to poor reporting, small study size and the fact that participants with TBI were usually only a proportion of the overall total. Meta-analysis was not feasible due to the paucity of data and heterogeneity of interventions and comparator groups. Some studies concluded that the intervention they tested had beneficial effects on spasticity, and others found no difference between certain treatments. The most common adverse event was minor skin damage in people who received casting. We believe it would be misleading to provide any further description of study results given the quality of the evidence was very low for all outcomes. AUTHORS' CONCLUSIONS: The very low quality and limited amount of evidence about the management of spasticity in people with TBI means that we are uncertain about the effectiveness or harms of these interventions. Well-designed and adequately powered studies using functional outcome measures to test the interventions used in clinical practice are needed.

Management of Spasticity in Moderate and Severe Traumatic Brain Injury: Evaluation of Clinical Practice Guidelines.

INTRODUCTION: Moderate to severe traumatic brain injury (TBI) can result in development of spasticity, which adversely affects function and quality of life. Given the foundation of optimal clinical practice is use of the best available evidence, we aimed to identify, describe, and evaluate methodological quality of evidence-based spasticity clinical practice guidelines (CPGs). METHODS: A comprehensive search for CPGs encompassed electronic databases and online sources. Eligible CPGs were evaluated using the validated Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument. RESULTS: Five CPGs were eligible for review; 2 were specific to acquired brain injury and 1 to TBI. The 3 brain injury-specific CPGs contained 423 recommendations overall, but only 8 spasticity recommendations. On the basis of AGREE appraisals, all CPGs performed well in the areas of reporting scope and purpose; clearly presenting recommendations; including various stakeholders in the CPG development process; and reporting conflict of interest. However, only one CPG performed adequately on describing facilitators and barriers to implementation, advice, and tools on how to implement recommendations and provision of audit criteria. Intraclass correlation coefficient (ICC) for agreement between raters showed high agreement (ICC > 0.80) for most guidelines. CONCLUSION: Given the unique etiological features and treatment challenges associated with managing spasticity after TBI, more TBI-specific spasticity CPGs are required. These should incorporate information on the facilitators and barriers to implementation, advice on implementing recommendations, and audit criteria.

The experience of discharge for patients with an acquired brain injury from the inpatient to the community setting: A qualitative review.

BACKGROUND: Discharge planning for patients with an acquired brain injury (ABI) is considered best practice for assisting the patient and caregiver to successfully transition from hospital to home and is complex because of the long-term care and support needs of the patient. This review aimed to describe and synthesize the perspectives of patients with ABI and their family/caregivers on the transition from hospital to home to better understand opportunities to optimize the process. METHODS: Electronic medical databases (n = 5) and grey literature published between January-May 2015 were searched to identify qualitative studies on the experience of transition from the hospital to home setting following ABI. Relevant studies were appraised and narratively synthesized. RESULTS: Nine eligible studies that met the inclusion criteria were identified. Two major themes were identified-Engagement and Support. Three underlying sub-themes-poor communication, limited participation and disorganized arrangements for support services-were identified as key contributors to an unsatisfactory experience for patients and their family/caregivers. CONCLUSION: The transition for patients with an ABI and their family/caregivers was characterized as fragmented and unsatisfactory for supporting a successful return home. This review highlights the importance of tailored education and involvement of the patient and their family/caregiver to increase readiness for returning home and reduce unplanned re-admissions.

Pharmacological interventions in traumatic brain injury: Can we rely on systematic reviews for evidence?

INTRODUCTION: Providing current, reliable and evidence based information for clinicians and researchers in a synthesised and summarised way can be challenging particularly in the area of traumatic brain injury where a vast number of reviews exists. These reviews vary in their methodological quality and are scattered across varying sources. In this paper, we present an overview of systematic reviews that evaluate the pharmacological interventions in traumatic brain injury (TBI). By doing this, we aim to evaluate the existing evidence for improved outcomes in TBI with pharmacological interventions, and to identify gaps in the literature to inform future research. METHODS: We searched the Neurotrauma Evidence Map on systematic reviews relating to pharmacological interventions for managing TBI in acute phase. Two reviewers independently screened search results and appraised each systematic review using the validated AMSTAR tool and extracted data from the review. RESULTS: A total of 288 systematic reviews relating to TBI were available on the Neurotrauma Evidence Map at the time of this study. We identified 19 systematic reviews on pharmacological management for acute TBI with publications dates ranging from 1998 to 2014. The studies were of varying methodological quality, with a mean AMSTAR score of 7.78 (range 2-11]. CONCLUSION: The evidence from high quality systematic reviews show that there is currently insufficient evidence for the use of magnesium, monoaminergic and dopamine agonists, progesterone, aminosteroids, excitatory amino acid inhibitors, haemostatic and antifibrinolytic drugs in TBI. Anti-convulsants are only effective in reducing early seizures with no significant difference between phenytoin and leviteracetam. There is no difference between propofol and midazolam for sedation in TBI patients and ketamine may not cause increased ICP. Overviews of systematic review provide informative and powerful summaries of evidence based research.

Quality of guidelines for cognitive rehabilitation following traumatic brain injury.

INTRODUCTION: Cognitive rehabilitation following traumatic brain injury can aid in optimizing function, independence, and quality of life by addressing impairments in attention, executive function, cognitive communication, and memory. This study aimed to identify and evaluate the methodological quality of clinical practice guidelines for cognitive rehabilitation following traumatic brain injury. METHODS: Systematic searching of databases and Web sites was undertaken between January and March 2012 to identify freely available, English language clinical practice guidelines from 2002 onward. Eligible guidelines were evaluated using the validated Appraisal of Guidelines for Research and Evaluation II instrument. RESULTS: The 11 guidelines that met inclusion criteria were independently rated by 4 raters. Results of quality appraisal indicated that guidelines generally employed systematic search and appraisal methods and produced unambiguous, clearly identifiable recommendations. Conversely, only 1 guideline incorporated implementation and audit information, and there was poor reporting of processes for formulating, reviewing, and ensuring currency of recommendations and incorporating patient preferences. Intraclass correlation coefficients for agreement between raters showed high agreement (intraclass correlation coefficient > 0.80) for all guidelines except for 1 (moderate agreement; intraclass correlation coefficient = 0.76). CONCLUSION: Future guidelines should address identified limitations by providing implementation information and audit criteria, along with better reporting of guideline development processes and stakeholder engagement.

Non-surgical interventions for the management of type 2 dens fractures: a systematic review.

BACKGROUND: Non-surgical immobilization strategies for type 2 odontoid fractures vary considerably, with some surgeons preferring rigid collars, halothoracic bracing or the Minerva brace. Choice of device should be informed by the effectiveness in achieving union, whilst minimizing mortality and complications. OBJECTIVES: Perform a systematic review evaluating the efficacy of non-surgical interventions for type 2 odontoid fractures. DATA SOURCES: MEDLINE (OvidSP), EMBASE (OvidSP) and The Cochrane Library, ClinicalTrials.gov, Current Controlled Trials. METHODS: We conducted a systematic review of studies directly comparing the halothoracic brace and cervical collars or the Minerva brace for union, mortality and complications. Studies were appraised for quality and bias, and results were pooled for analysis. RESULTS: Our search identified 1794 citations, 13 of which met inclusion criteria. There were no randomized or prospective studies. All studies were small, retrospective and observational. Our results demonstrate a greater likelihood of developing stable union (osseous and fibrous); relative risk (RR) 1.27 (95% confidence intervals (CI) 1.03 to 1.57; P = 0.03); and airway complications; RR 7.52 (95% CI 1.39 to 40.83; P = 0.02) with halothoracic bracing compared with cervical collar. In patients >65, there was a greater risk of airway complications; RR 7.50 (0.96-58.36; P = 0.05). No other significant differences were identified. CONCLUSION: Evidence to support selection of non-surgical immobilization in type 2 odontoid fractures is poor. Osseous union has traditionally been the benchmark for 'successful' treatment; however, evidence of association between union and improved outcomes is lacking. We highlight the need for a randomized study to promote evidence-based decision-making in the non-surgical management of this injury.

Safety and efficacy of pharmacologic thromboprophylaxis following blunt head injury: a systematic review.

BACKGROUND: Patients with blunt head injury are at high risk of venous thromboembolism. However, pharmacologic thromboprophylaxis (PTP) may cause progression of intracranial hemorrhage, and clinicians must often weigh up the risks and benefits. This review aimed to determine whether adding PTP to mechanical prophylaxis confers net benefit or harm and the optimal timing, dose, and agent for PTP in patients with blunt head injury. METHODS: We searched MEDLINE, EMBASE, The Cochrane Library Central Register of Controlled Trials (CENTRAL), and www.clinicaltrials.gov on April 24, 2013, to identify controlled studies and ongoing trials that assessed the efficacy or safety of thromboprophylaxis interventions in the early management of head-injured patients. Studies were classified based on types of interventions and comparisons, and the quality of included studies was assessed using Cochrane risk-of-bias tool and the Newcastle-Ottawa Quality Assessment Scale. We intended to undertake a meta-analysis if studies were sufficiently similar. RESULTS: Sixteen studies met the inclusion criteria, including four randomized controlled trials. At least two randomized controlled trials were at high risk of bias owing to inadequate randomization and concealment of allocation, and observational studies were potentially confounded by substantial differences between comparison groups. Heterogeneity of included studies precluded meta-analysis. Results were mixed, with some studies supporting and others refuting addition of PTP to mechanical interventions. Little evidence was available about dose or choice of agent. The safety and efficacy of early PTP in patients without early progression of hemorrhage is unclear. CONCLUSION: There is currently insufficient evidence to guide thromboprophylaxis in patients with blunt head injury. Standardized definitions and outcome measurements would facilitate comparison of outcomes across future studies. Studies in mixed populations should report head-injured specific subgroup data. Future randomized controlled trials should investigate the efficacy and safety of early pharmacologic prophylaxis in addition to mechanical intervention. LEVEL OF EVIDENCE: Systematic review, level IV.

Review article: Prehospital fluid management in traumatic brain injury.

The early management of patients who have sustained traumatic brain injury is aimed at preventing secondary brain injury through avoidance of cerebral hypoxia and hypoperfusion. Especially in hypotensive patients, it has been postulated that hypertonic crystalloids and colloids might support mean arterial pressure more effectively by expanding intravascular volume without causing problematic cerebral oedema. We conducted a systematic review to investigate if hypertonic saline or colloids result in better outcomes than isotonic crystalloid solutions, as well as to determine the safety of minimal volume resuscitation, or delayed versus immediate fluid resuscitation during prehospital care for patients with traumatic brain injury. We identified nine randomized controlled trials and one cohort study examined the effects of hypertonic solutions (with or without colloid added) for prehospital fluid resuscitation. None has reported better survival and functional outcomes over the use of isotonic crystalloids. The only trial of restrictive resuscitation strategies was underpowered to demonstrate its safety compared with aggressive early fluid resuscitation in head injured patients, and maintenance of cerebral perfusion remains the top priority.