Clinical pharmacy key performance indicators for hospital inpatient setting: a systematic review.

BACKGROUND: Key performance indicators (KPIs) are quantifiable measures used to monitor the quality of health services. Implementation guidelines for clinical pharmacy services (CPS) do not specify KPIs. AIM: To assess the quality of the studies that have developed KPIs for CPS in inpatient hospital settings. METHOD: A systematic review was conducted by searching in Web of Science, Scopus, and PubMed, supplemented with citation analyses and grey literature searches, to retrieve studies addressing the development of KPIs in CPS for hospital inpatients. Exclusions comprised drug- or disease-specific studies and those not written in English, French, Portuguese, or Spanish. The Appraisal of Indicators through Research and Evaluation (AIRE) instrument assessed methodological quality. Domain scores and an overall score were calculated using an equal-weight principle. KPIs were classified into structure, process, and outcome categories. The protocol is available at https://doi.org/10.17605/OSF.IO/KS2G3 . RESULTS: We included thirteen studies that collectively developed 225 KPIs. Merely five studies scored over 50% on the AIRE instrument, with domains #3 (scientific evidence) and #4 (formulation and usage) displaying low scores. Among the KPIs, 8.4% were classified as structure, 85.8% as process, and 5.8% as outcome indicators. The overall methodological quality did not exhibit a clear association with a major focus on outcomes. None of the studies provided benchmarking reference values. CONCLUSION: The KPIs formulated for evaluating CPS in hospital settings primarily comprised process measures, predominantly suggested by pharmacists, with inadequate evidence support, lacked piloting or validation, and consequently, were devoid of benchmarking reference values.

Outcomes of subsequent pregnancy in women with peripartum cardiomyopathy: a systematic review and meta-analysis.

INTRODUCTION: The primary concern for women who have experienced peripartum cardiomyopathy (PPCM) is the safety of a subsequent pregnancy (SSP). To maximie decision-making, facilitate effective patient counselling, and ultimately improve maternal and fetal outcomes as a whole, it is critical to comprehend the outcomes of SSP in women who have previously experienced PPCM. This study aimed to evaluate the outcomes of SSP in women with PPCM. METHODS: Three databases (PubMed, Scopus, and ScienceDirect) were used to identify relevant studies prior to 17 October 2023. A total of 662 studies were reviewed. Following the abstract and full-text screenings, 18 observational studies were included, out of which 2 were deemed suitable for inclusion in this meta-analysis. The quality assessment was conducted using the Newcastle-Ottawa Scale. RESULTS: This study has a total of 487 SSPs. Although recovered left ventricular (LV) function before entering SSP has the potential to be a beneficial prognostic factor, recovered LV function still has a substantial risk of relapse. The mortality rate of PPCM in an SSP ranged from 0% to 55.5%. Persistent LV dysfunction was significantly associated with an increased mortality rate (OR 13.17; 95% CI 1.54 to 112.28; p=0.02) and lower LV ejection fraction (MD -12.88; 95% CI -21.67 to -4.09; p=0.004). Diastolic and right ventricular functions remained unchanged before SSP and at follow-up. The majority of the SSP was observed alongside hypertension, while pre-eclampsia emerged as the predominant hypertensive complication in most studies. CONCLUSION: SSP increases the risk of relapse and mortality in women with a previous history of PPCM. Persistent LV dysfunction prior to the SSP has a higher mortality risk compared with recovered LV function. SSP was also associated with the worsening of LV echocardiography parameters.

Rapid reviews methods series: assessing the appropriateness of conducting a rapid review.

This paper, part of the Cochrane Rapid Review Methods Group series, offers guidance on determining when to conduct a rapid review (RR) instead of a full systematic review (SR). While both review types aim to comprehensively synthesise evidence, RRs, conducted within a shorter time frame of typically 6 months or less, involve streamlined methods to expedite the process. The decision to opt for an RR depends on the urgency of the research question, resource availability and the impact on decision outcomes. The paper categorises scenarios where RRs are appropriate, including urgent decision-making, informing guidelines, assessing new technologies and identifying evidence gaps. It also outlines instances when RRs may be inappropriate, cautioning against conducting them solely for ease, quick publication or only cost-saving motives.When deciding on an RR, it is crucial to consider both conceptual and practical factors. These factors encompass the urgency of needing timely evidence, the consequences of waiting for a full SR, the potential risks associated with incomplete evidence, and the risk of not using synthesised evidence in decision-making, among other considerations. Key factors to weigh also include having a clearly defined need, a manageable scope and access to the necessary expertise. Overall, this paper aims to guide informed judgements about whether to choose an RR over an SR based on the specific research question and context. Researchers and decision-makers are encouraged to carefully weigh potential trade-offs when opting for RRs.

Rapid reviews methods series: guidance on rapid qualitative evidence synthesis.

This paper forms part of a series of methodological guidance from the Cochrane Rapid Reviews Methods Group and addresses rapid qualitative evidence syntheses (QESs), which use modified systematic, transparent and reproducible methodsu to accelerate the synthesis of qualitative evidence when faced with resource constraints. This guidance covers the review process as it relates to synthesis of qualitative research. 'Rapid' or 'resource-constrained' QES require use of templates and targeted knowledge user involvement. Clear definition of perspectives and decisions on indirect evidence, sampling and use of existing QES help in targeting eligibility criteria. Involvement of an information specialist, especially in prioritising databases, targeting grey literature and planning supplemental searches, can prove invaluable. Use of templates and frameworks in study selection and data extraction can be accompanied by quality assurance procedures targeting areas of likely weakness. Current Cochrane guidance informs selection of tools for quality assessment and of synthesis method. Thematic and framework synthesis facilitate efficient synthesis of large numbers of studies or plentiful data. Finally, judicious use of Grading of Recommendations Assessment, Development and Evaluation approach for assessing the Confidence of Evidence from Reviews of Qualitative research assessments and of software as appropriate help to achieve a timely and useful review product.

The confidence in the results of physiotherapy systematic reviews in the musculoskeletal field is not increasing over time: a meta-epidemiological study using AMSTAR 2 tool.

OBJECTIVES: To assess the confidence in the results of systematic reviews on the effectiveness of physiotherapy for musculoskeletal conditions in the past 10 years and to analyze trends and factors associated. METHODS: This is a metaepidemiological study on systematic reviews (SRs) with meta-analysis of randomized controlled trials (RCTs). MEDLINE, Cochrane Database of Systematic Reviews, CINAHL, and PEDro were searched for SRs of RCT on physiotherapy interventions for musculoskeletal disorders from December 2012 to December 2022. Two researchers independently screened the records based on the inclusion criteria; a random sample of 100 studies was selected, and each journal, author, and study variable was extracted. The methodological quality of SRs was independently assessed with the AMSTAR 2 tool. Any disagreement was solved by consensus. RESULTS: The confidence in SRs results was critically low in 90% of the studies, and it did not increase over time. Cochrane reviews are predominantly represented in the higher AMSTAR 2 confidence levels, with a statistically significant difference compared to non-Cochrane reviews. The last author's H-index is the only predictor of higher confidence among the variables analyzed (OR 1.04; 95% CI: 1.01, 1.06). CONCLUSION: The confidence in SRs results is unacceptably low. Given the relevance of musculoskeletal disorders and the impact of evidence synthesis on the clinical decision-making process, there is an urgent need to improve the quality of secondary research by adopting more rigorous methods.

Integrating large language models in systematic reviews: a framework and case study using ROBINS-I for risk of bias assessment.

Large language models (LLMs) may facilitate and expedite systematic reviews, although the approach to integrate LLMs in the review process is unclear. This study evaluates GPT-4 agreement with human reviewers in assessing the risk of bias using the Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I) tool and proposes a framework for integrating LLMs into systematic reviews. The case study demonstrated that raw per cent agreement was the highest for the ROBINS-I domain of 'Classification of Intervention'. Kendall agreement coefficient was highest for the domains of 'Participant Selection', 'Missing Data' and 'Measurement of Outcomes', suggesting moderate agreement in these domains. Raw agreement about the overall risk of bias across domains was 61% (Kendall coefficient=0.35). The proposed framework for integrating LLMs into systematic reviews consists of four domains: rationale for LLM use, protocol (task definition, model selection, prompt engineering, data entry methods, human role and success metrics), execution (iterative revisions to the protocol) and reporting. We identify five basic task types relevant to systematic reviews: selection, extraction, judgement, analysis and narration. Considering the agreement level with a human reviewer in the case study, pairing artificial intelligence with an independent human reviewer remains required.

Designing tailored maintenance strategies for systematic reviews and clinical practice guidelines using the Portfolio Maintenance by Test-Treatment (POMBYTT) framework.

BACKGROUND: Organizations face diverse contexts and requirements when updating and maintaining their portfolio, or pool, of systematic reviews or clinical practice guidelines they need to manage. We aimed to develop a comprehensive, theoretical framework that might enable the design and tailoring of maintenance strategies for portfolios containing systematic reviews and guidelines. METHODS: We employed a conceptual approach combined with a literature review. Components of the diagnostic test-treatment pathway used in clinical healthcare were transferred to develop a framework specifically for systematic review and guideline portfolio maintenance strategies. RESULTS: We developed the Portfolio Maintenance by Test-Treatment (POMBYTT) framework comprising diagnosis, staging, management, and monitoring components. To illustrate the framework's components and their elements, we provided examples from both a clinical healthcare test-treatment pathway and a clinical practice guideline maintenance scenario. Additionally, our literature review provided possible examples for the elements in the framework, such as detection variables, detection tests, and detection thresholds. We furthermore provide three example strategies using the framework, of which one was based on living recommendations strategies. CONCLUSIONS: The developed framework might support the design of maintenance strategies that could contain multiple options besides updating to manage a portfolio (e.g. withdrawing and archiving), even in the absence of the target condition. By making different choices for variables, tests, test protocols, indications, management options, and monitoring, organizations might tailor their maintenance strategy to suit specific contexts and needs. The framework's elements could potentially aid in the design by being explicit about the operational aspects of maintenance strategies. This might also be helpful for end-users and other stakeholders of systematic reviews and clinical practice guidelines.

What is the most dangerous sexual position that caused the penile fracture? A systematic review and meta-analysis.

PURPOSE: Penile fracture (PF) affects 1,14 to 10,48 men in every 100.000 men in East Asia, and the primary aetiology is sexual intercourse, but the knowledge regarding the most dangerous sexual position is not well explained. This study compares three sexual positions: man on top position (MTP), woman on top position (WTP), and doggy style position (DSP), leading to PF potential. MATERIALS AND METHODS: A search of sexual position-related PF in Google Scholar, PubMed, Cochrane, and PMC Europe was performed. Criteria inclusion was the full text of relevant articles which describ the number of sexual positions. It was analyzed by odds ratio, random model effect, and the OR and 95%CI were calculated. RESULTS: 12 relevant papers involving 490 patients comprised 169 MTP, 120 WTP, 158 DSP, and 43 no intercourse cases. Meta-analysis of all sexual positions was a MTP P= 0,04, WTP P=0,49, and DSP P=0,0005. CONCLUSION: The man-dominant positions (MTP and DSP) were significantly potential for PF, which speculated that when a man is dominant and very excited, intercourse may become highly vigorous and impact trauma. This study found that man's dominant position consists of DSP and the MTP significantly lead to PF.

Rapid Reviews Methods Series: Involving patient and public partners, healthcare providers and policymakers as knowledge users.

Rapid reviews (RRs) are a helpful evidence synthesis tool to support urgent and emergent decision-making in healthcare. RRs involve abbreviating systematic review methods and are conducted in a condensed timeline to meet the decision-making needs of organisations or groups that commission them. Knowledge users (KUs) are those individuals, typically patient and public partners, healthcare providers, and policy-makers, who are likely to use evidence from research, including RRs, to make informed decisions about health policies, programmes or practices. However, research suggests that KU involvement in RRs is often limited or overlooked, and few RRs include patients as KUs. Existing RR methods guidance advocates involving KUs but lacks detailed steps on how and when to do so. This paper discusses the importance of involving KUs in RRs, including patient and public involvement to ensure RRs are fit for purpose and relevant for decision-making. Opportunities to involve KUs in planning, conduct and knowledge translation of RRs are outlined. Further, this paper describes various modes of engaging KUs during the review lifecycle; key considerations researchers should be mindful of when involving distinct KU groups; and an exemplar case study demonstrating substantive involvement of patient partners and the public in developing RRs. Although involving KUs requires time, resources and expertise, researchers should strive to balance 'rapid' with meaningful KU involvement in RRs. This paper is the first in a series led by the Cochrane Rapid Reviews Methods Group to further guide general RR methods.

Interpretation and use of a decision support tool for multiple treatment options: a combined randomised controlled trial and survey of medical students.

OBJECTIVES: To investigate medical students' ability to interpret evidence, as well as their self-assessed understandability, perceived usefulness and preferences for design alternatives in an interactive decision support tool, displaying GRADE evidence summaries for multiple treatment options (Making Alternative Treatment CHoices Intuitive and Trustworthy, MATCH-IT). DESIGN: A combined randomised controlled trial and survey. Participants were presented with a clinical scenario and randomised to one of two versions of the MATCH-IT tool (A/B), instructed to explore the evidence and decide on a recommendation. Participants answered a questionnaire assessing interpretation, treatment recommendation self-assessed understandability and perceived usefulness before exposure to the other MATCH-IT version and asked questions on design preferences. SETTING: Online lecture in an evidence-based medicine (EBM) introductory course. PARTICIPANTS: 149 third-year medical students. 52% (n=77) had 6 months of clinical training and 48% (n=72) had preclinical training only. INTERVENTIONS: The MATCH-IT tool version A uses colour coding to categorise interventions by magnitude and direction of effects and displays all outcomes in a table on entry. Version B has no colour coding, and the user must decide which outcomes to display in the table. MAIN OUTCOME MEASURES: Interpretation of evidence, treatment recommendation, perceived usefulness and understandability, preference for format and design alternatives. RESULTS: 82.5% (n=123) of medical students correctly answered ≥4 out of 5 multiple choice questions assessing interpretation of data. 75.8% (n=114) of students made a treatment recommendation in accordance with an expert panel for the same clinical scenario. 87.2% (n=130) found the tool understandable while 91.9% perceived the tool as useful in addressing the clinical scenario. CONCLUSION: Medical students with no prior training in EBM can interpret and use the MATCH-IT tool. Certain design alternatives were preferred but had no bearing on interpretation of evidence or understandability of the tool.

The effects of cinnamon supplementation on adipokines and appetite-regulating hormones: A systematic review of randomized clinical trials.

Objective: Cinnamon is extracted from the inner bark of Cinnamomum trees. Recent studies have indicated that cinnamon is a safe and cost-effective treatment for improving body weight, lipid profiles, insulin resistance, and blood pressure. This systematic review aimed to summarize the effect of cinnamon supplementation on adipokines and appetite-regulating hormones. Materials and Methods: This comprehensive literature search was conducted using databases such as PubMed, Scopus, ISI Web of Science, and Google Scholar up to March 2022 without any limitation. The quality of eligible studies was evaluated through the Cochrane Collaboration's tool for assessing the risk of bias. Results: This systematic review included six clinical trial studies (363 participants), among which, only one study was performed on children, and two investigations were conducted on obese participants. A decreasing effect was found in the level of leptin and visfatin after cinnamon supplementation. Two out of three studies examined adiponectin levels and revealed non-significant effects of cinnamon consumption on this parameter. Two studies evaluated ghrelin levels and found an increase after cinnamon supplementation. The result of cinnamon supplementation on other biomarkers such as glucose-dependent insulinotropic polypeptide, glucagon-like peptide 1, and resistin was inconsistent. Conclusion: The result of this systematic review indicated the increasing effect of cinnamon supplementation on ghrelin levels and decreasing effect on leptin and visfatin levels. However, more clinical data are required to clarify the beneficial effects of cinnamon on adipokines levels due to the controversial findings of the studies.

Integrating palliative care and heart failure: a systematic realist synthesis (PalliatHeartSynthesis).

OBJECTIVES: (1) Develop a programme theory of why, for whom and in what contexts integrated palliative care (PC) and heart failure (HF) services work/do not work; (2) use the programme theory to co-produce with stakeholders, intervention strategies to inform best practice and future research. METHODS: A systematic review of all published articles and grey literature using a realist logic of analysis. The search strategy combined terms significant to the review questions: HF, PC and end of life. Documents were included if they were in English and provided data relevant to integration of PC and HF services. Searches were conducted in November 2021 in EMBASE, MEDLINE, PsycINFO, AMED, HMIC and CINAHL. Further relevant documents were identified via monthly alerts (up until April 2023) and the project stakeholder group (patient/carers, content experts and multidisciplinary practitioners). RESULTS: 130 documents were included (86 research, 22 literature reviews, 22 grey literature). The programme theory identified intervention strategies most likely to support integration of PC and HF services. These included protected time for evidence-based PC and HF education from undergraduate/postgraduate level and continuing professional practice; choice of educational setting (eg, online, face-to-face or hybrid); increased awareness and seeing benefits of PC for HF management; conveying the emotive and intellectual need for integrating PC and HF via credible champions; and prioritising PC and HF guidelines in practice. CONCLUSIONS: The review findings outline the required steps to take to increase the likelihood that all key players have the capacity, opportunity and motivation to integrate PC into HF management. PROSPERO REGISTRATION NUMBER: CRD42021240185.

Effect of aerobic exercise training on pulse wave velocity in adults with and without long-term conditions: a systematic review and meta-analysis.

RATIONALE: There is conflicting evidence whether aerobic exercise training (AET) reduces pulse wave velocity (PWV) in adults with and without long-term conditions (LTCs). OBJECTIVE: To explore whether PWV improves with AET in adults with and without LTC, to quantify the magnitude of any effect and understand the influence of the exercise prescription. DATA SOURCES: CENTRAL, MEDLINE and EMBASE were among the databases searched. ELIGIBILITY CRITERIA: We included studies with a PWV measurement before and after supervised AET of at least 3 weeks duration. Exclusion criteria included resistance exercise and alternative measures of arterial stiffness. DESIGN: Controlled trials were included in a random effects meta-analysis to explore the effect of AET on PWV. Uncontrolled studies were included in a secondary meta-analysis and meta-regression exploring the effect of patient and programme factors on change in PWV. The relevant risk of bias tool was used for each study design. RESULTS: 79 studies (n=3729) were included: 35 controlled studies (21 randomised control trials (RCT) (n=1240) and 12 non-RCT (n=463)) and 44 uncontrolled (n=2026). In the controlled meta- analysis, PWV was significantly reduced following AET (mean (SD) 11 (7) weeks) in adults with and without LTC (mean difference -0.63; 95% CI -0.82 to -0.44; p<0.0001). PWV was similarly reduced between adults with and without LTC (p<0.001). Age, but not specific programme factors, was inversely associated with a reduction in PWV -0.010 (-0.020 to -0.010) m/s, p<0.001. DISCUSSION: Short-term AET similarly reduces PWV in adults with and without LTC. Whether this effect is sustained and the clinical implications require further investigation.

Eosinophilic myocarditis: systematic review.

OBJECTIVE: In clinical practice, patients with eosinophilic myocarditis (EM) may forgo the gold standard diagnostic procedure, endomyocardial biopsy (EMB), although it is highly recommended in guidelines. This systematic review aims to summarise current approaches in diagnosing and treating EM with a particular emphasis on the utilisation and value of alternative diagnostic methods. METHODS: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, we searched MEDLINE and EMBASE for all peer-reviewed articles using the keywords "eosinophilic myocarditis" from their inception to 10 September 2022. RESULTS: We included 239 articles, including 8 observational studies and 274 cases, in this review. The median patient age was 45 years. Initial presentations were non-specific, including dyspnoea (50.0%) and chest pain (39.4%). The aetiologies of EM were variable with the most common being idiopathic (28.8%) and eosinophilic granulomatosis polyangiitis (19.3%); others included drug-induced (13.1%) and hypereosinophilic syndrome (12.8%). 82.4% received an EM diagnosis by EMB while 17.6% were diagnosed based on clinical reasoning and cardiac MRI (CMR). CMR-diagnosed patients exhibited a better risk profile at diagnosis, particularly higher left ventricular ejection fraction and less need for inotropic or mechanical circulatory supports. Glucocorticoids were the primary treatment with variability in dosages and regimens. CONCLUSION: EMB is the mainstay for diagnostic testing for EM. CMR is potentially helpful for screening in appropriate clinical scenarios. Regarding treatment, there is no consensus regarding the optimal dosage of corticosteroids. Large clinical trials are warranted to further explore the utility of CMR in the diagnosis of EM and steroid regimen in treating EM.

How much do children with disabilities participate in Clinical Trials? A Scoping review.

BACKGROUND: Children with disabilities (CWDs) are often excluded from scientific research, but no precise data are available on their participation in Clinical Trials. The aim of this study was to evaluate the rates of exclusion of CWDs from recent medical research. SUBJECTS AND METHODS: The protocol of the study was designed according to Prisma-ScR guidelines. All completed interventional Clinical Trials registered on Clinicaltrials.gov between 2010 and 2020 related to the Leading 10 Level 3 causes of global Disability-adjusted life years (DALYs) for both sexes combined for all ages of the updated Global Burden of Disease Study 2019 were analysed. The exclusion criteria were considered explicit if related to the following categories: disability, physical impairment, cognitive impairment, behavioural or psychiatric disorders, language and communication impairment, sensory impairment. Any generic or poorly specified exclusion criteria or statements that left wide discretion to researchers were considered "implicit exclusion criteria". We assessed the appropriateness of explicit exclusion criteria in relation to the primary objectives of the trials and labelled them as "absolute", "relative", or "questionable". RESULTS: The trials selected according to the inclusion criteria of the scoping review were 328; 166 (50.6%) were pediatric-only studies, and 162 (49.4%) trials comprising subjects of all ages. Explicit exclusion criteria were found in 82 trials (25%) and the disability category most frequently excluded was "Behavioural or psychiatric disorders" present in 46 trials (56.1%). Explicit exclusion criteria were considered "relative" in over 90% of the selected studies. Implicit exclusion criteria were present in 153 trials (46.6%) and the number and percentage of studies with at least one explicit or implicit exclusion criterion were 193 and 58.8% respectively. CONCLUSIONS: This study highlights a high rate of exclusion of CWDs from medical research and the need for an inclusive approach that comprises the study design and any necessary adaptations for specific needs.

Heart-to-heart with ChatGPT: the impact of patients consulting AI for cardiovascular health advice.

OBJECTIVES: The advent of conversational artificial intelligence (AI) systems employing large language models such as ChatGPT has sparked public, professional and academic debates on the capabilities of such technologies. This mixed-methods study sets out to review and systematically explore the capabilities of ChatGPT to adequately provide health advice to patients when prompted regarding four topics from the field of cardiovascular diseases. METHODS: As of 30 May 2023, 528 items on PubMed contained the term ChatGPT in their title and/or abstract, with 258 being classified as journal articles and included in our thematic state-of-the-art review. For the experimental part, we systematically developed and assessed 123 prompts across the four topics based on three classes of users and two languages. Medical and communications experts scored ChatGPT's responses according to the 4Cs of language model evaluation proposed in this article: correct, concise, comprehensive and comprehensible. RESULTS: The articles reviewed were fairly evenly distributed across discussing how ChatGPT could be used for medical publishing, in clinical practice and for education of medical personnel and/or patients. Quantitatively and qualitatively assessing the capability of ChatGPT on the 123 prompts demonstrated that, while the responses generally received above-average scores, they occupy a spectrum from the concise and correct via the absurd to what only can be described as hazardously incorrect and incomplete. Prompts formulated at higher levels of health literacy generally yielded higher-quality answers. Counterintuitively, responses in a lower-resource language were often of higher quality. CONCLUSIONS: The results emphasise the relationship between prompt and response quality and hint at potentially concerning futures in personalised medicine. The widespread use of large language models for health advice might amplify existing health inequalities and will increase the pressure on healthcare systems by providing easy access to many seemingly likely differential diagnoses and recommendations for seeing a doctor for even harmless ailments.