Functional outcomes of bowel resection versus shaving or disc excision of colorectal endometriosis: a systematic review protocol.

INTRODUCTION: Endometriosis is a prevalent gynaecological condition for women of reproductive age worldwide. While endometriosis primarily involves the reproductive system, it can also infiltrate additional viscera such as the gastrointestinal tract. Patients with colorectal endometriosis can have severe symptoms that require surgical intervention. There are limited data available to guide the choice of resection technique based on the functional outcomes of bowel resection versus shaving or disc excision in treating colorectal endometriosis. This protocol aims to outline the methods that will be used in a systematic review of the literature comparing the functional outcomes of bowel resection to shaving and disc excision when surgically treating colorectal endometriosis. METHODS AND ANALYSIS: Papers will be identified through database searches, scanning reference lists of relevant studies and citation searching of key papers. Two independent reviewers will screen studies against eligibility criteria and extract data using standardised forms. Databases including MEDLINE, EMBASE and Cochrane will be searched from the beginning of each database until February 2024. The primary outcome is comparing the functional bowel outcomes between the different methods of surgical treatment. Secondary outcome will be quality of life, based on the Low Anterior Resection Syndrome score and the incidence of postoperative pain. A meta-analysis will be performed if the data are homogenous. ETHICS AND DISSEMINATION: This study does not require ethics approval. The results of the systematic review described within this protocol will be disseminated through presentations at relevant conferences and publication in a peer-reviewed journal. The methods will be used to inform future reviews. PROSPERO REGISTRATION NUMBER: CRD42023461711.

Does Collaboration between General Practitioners and Pharmacists Improve Risk Factors for Cardiovascular Disease and Diabetes? A Systematic Review and Meta-Analysis.

Objective: To assess whether inter-professional, bidirectional collaboration between general practitioners (GPs) and pharmacists has an impact on improving cardiovascular risk outcomes among patients in the primary care setting. It also aimed to understand the different types of collaborative care models used. Study design: Systematic review and Hartung-Knapp-Sidik-Jonkman random effects meta-analyses of randomised control trials (RCTs) in inter-professional bidirectional collaboration between GP and pharmacists assessing a change of patient cardiovascular risk in the primary care setting. Data sources: MEDLINE, EMBASE, Cochrane, CINAHL and International Pharmaceutical Abstracts, scanned reference lists of relevant studies, hand searched key journals and key papers until August 2021. Data synthesis: Twenty-eight RCTs were identified. Collaboration was associated with significant reductions in systolic and diastolic blood pressure (23 studies, 5,620 participants) of -6.42 mmHg (95% confidence interval (95%CI) -7.99 to -4.84) and -2.33 mmHg (95%CI -3.76 to -0.91), respectively. Changes in other cardiovascular risk factors included total cholesterol (6 studies, 1,917 participants) -0.26 mmol/L (95%CI -0.49 to -0.03); low-density lipoprotein (8 studies, 1,817 participants) -0.16 mmol/L (95%CI -0.63 to 0.32); high-density lipoprotein (7 studies, 1,525 participants) 0.02 mmol/L (95%CI -0.02 to 0.07). Reduction in haemoglobin A1c (HbA1C) (10 studies, 2,025 participants), body mass index (8 studies, 1,708 participants) and smoking cessation (1 study, 132 participants) was observed with GP-pharmacist collaboration. Meta-analysis was not conducted for these changes. Various models of collaborative care included verbal communication (via phone calls or face to face), and written communication (emails, letters). We found that co-location was associated with positive changes in cardiovascular risk factors. Conclusion: Although it is clear that collaborative care is ideal compared to usual care, greater details in the description of the collaborative model of care in studies is required for a core comprehensive evaluation of the different models of collaboration.

Do bisphosphonates and RANKL inhibitors alter the progression of coronary artery calcification? A systematic review and meta-analysis protocol.

INTRODUCTION: Whether bisphosphonates and RANKL inhibitors play a novel role in delaying cardiovascular calcification is unknown. Their action on regulatory enzymes in the mevalonic acid pathway, which is implicated in both bone and lipid metabolism, may be a novel therapeutic target to manage coronary artery disease (CAD). Such therapies may particularly be relevant in those for whom traditional cardiovascular therapies are no longer sufficient to control disease progression. METHODS AND ANALYSIS: We will perform a systematic review which aims to synthesise evidence regarding whether use of bisphosphonates or use of the RANKL inhibitor denosumab delays coronary artery calcium (CAC) progression. Eligible studies will include longitudinal studies investigating CAC progression in patients aged >18 years taking either a bisphosphonate or denosumab compared with those who do not. Embase, MEDLINE and Cochrane will be searched using prespecified search terms. Studies will be screened by title and abstract independently and then in full to determine suitability for inclusion in the review. Extracted data will include that relating to study and participant characteristics. The primary outcome will be the CAC score. Secondary outcomes will include aortic and carotid artery calcification. Meta-analysis will be performed if sufficient data are available. ETHICS AND DISSEMINATION: This study does not require ethics as it is a systematic review of the literature. The results of the review described within this protocol will be distributed via presentations at relevant conferences and publication within a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: The systematic review pertaining to this protocol is registered with PROSPERO (Registration ID: CRD42022312377).

Voriconazole: an audit of hospital-based dosing and monitoring and evaluation of the predictive performance of a dose-prediction software package.

BACKGROUND: Therapeutic drug monitoring (TDM) is recommended to guide voriconazole therapy. OBJECTIVES: To determine compliance of hospital-based voriconazole dosing and TDM with the Australian national guidelines and evaluate the predictive performance of a one-compartment population pharmacokinetic voriconazole model available in a commercial dose-prediction software package. METHODS: A retrospective audit of voriconazole therapy at an Australian public hospital (1 January to 31 December 2016) was undertaken. Data collected included patient demographics, dosing history and plasma concentrations. Concordance of dosing and TDM with Australian guidelines was assessed. Observed concentrations were compared with those predicted by dose-prediction software. Measures of bias (mean prediction error) and precision (mean squared prediction error) were calculated. RESULTS: Adherence to dosing guidelines for 110 courses of therapy (41% for prophylaxis and 59% for invasive fungal infections) was poor, unless oral formulation guidelines recommended a 200 mg dose, the most commonly prescribed dose (56% of prescriptions). Plasma voriconazole concentrations were obtained for 82% (90/110) of courses [median of 3 (range: 1-27) obtained per course]. A minority (27%) of plasma concentrations were trough concentrations [median concentration: 1.5 mg/L (range: <0.1 to >5.0 mg/L)]. Of trough concentrations, 57% (58/101) were therapeutic, 37% (37/101) were subtherapeutic and 6% (6/101) were supratherapeutic. The dose-prediction software performed well, with acceptable bias and precision of 0.09 mg/L (95% CI -0.08 to 0.27) and 1.32 (mg/L)2 (95% CI 0.96-1.67), respectively. CONCLUSIONS: Voriconazole dosing was suboptimal based on published guidelines and TDM results. Dose-prediction software could enhance TDM-guided therapy.

Effect of dose administration aids on adherence to self-administered medications: a systematic review protocol.

INTRODUCTION: Forgetting to take a medication is the most common reason for non-adherence to self-administered medication. Dose administration aids (DAAs) are a simple and common solution to improve unintentional non-adherence for oral tablets. DAAs can be in the form of compartmentalised pill boxes, automated medication dispensing devices, blister packs and sachets packets. This protocol aims to outline the methods that will be used in a systematic review of the current literature to assess the impact of DAAs on adherence to medications and health outcomes. METHODS AND ANALYSIS: Randomised controlled trials will be identified through electronic searches in databases including EMBASE, MEDLINE, CINAHL and the Cochrane Library, from the beginning of each database until January 2020. Two reviewers will independently screen studies and extract data using the standardised forms. Data extracted will include general study information, characteristics of the study, participant characteristics, intervention characteristics and outcomes. Primary outcome is to assess the effects of DAAs on medication adherence. Secondary outcome is to evaluate the changes in health outcomes. The risk of bias will be ascertained by two reviewers in parallel using The Cochrane Risk of Bias Tool. A meta-analysis will be performed if data are homogenous. ETHICS AND DISSEMINATION: Ethics approval will not be required for this study. The results of the review described within this protocol will be disseminated through publication in a peer-reviewed journal and relevant conference presentations. PROSPERO REGISTRATION NUMBER: CRD42018096087.

Does splitting a tablet obtain the accurate dose?: A systematic review protocol.

BACKGROUND: Physical manipulation of the manufactured dose form is a common practice, with almost a quarter of all drugs administered in primary care having their dose altered. Splitting a tablet can be advantageous as it facilitates swallowing, allows for dose flexibility and provides cost reductions. However, there are concerns these physical changes can lead to inaccurate portions resulting in significant variations from the prescribed dose. Thus, the review described in this protocol aims to summarise the literature assessing the effect of tablet splitting on dose accuracy. METHODS: Relevant studies will be identified through electronic searches in databases including EMBASE, MEDLINE, CINAHL, and the Cochrane Library, from the beginning of databases until January 2020. Studies investigating any drug, where the tablet was split, will be potentially eligible. Two reviewers will independently screen studies and extract data using standardised forms. Data extracted will include general study information, characteristics of the study, intervention characteristics and outcomes. Primary outcome is to assess dose accuracy of a split tablet measured by drug content or weight variability. Assessment of risk of bias will be dependent upon study design. If deemed feasible, meta-analysis will be performed. RESULTS: The study described within this protocol will provide a synthesis of current evidence assessing the effect of tablet splitting on dose accuracy. CONCLUSION: The conclusion of our study will provide evidence to judge whether splitting a tablet results in an accurate half dose. ETHICS AND DISSEMINATION: Ethics approval was not required for this study. The results of the systematic review described will be published in a peer-reviewed journal. REGISTRATION DETAILS: PROSPERO CRD42018106252.

General practitioner and pharmacist collaboration: does this improve risk factors for cardiovascular disease and diabetes? A systematic review protocol.

INTRODUCTION: Cardiovascular disease (CVD) remains a major cause of morbidity and premature mortality globally. Despite the availability of low-cost evidence based medicines, there is a significant treatment gap in those with established or at high risk of CVD in the primary care setting. Pharmacist-based interventions have shown to improve patient outcomes for many chronic diseases including CVD. However, there is little synthesised evidence that has examined the effects of collaborative care between general practitioners (GPs) and pharmacists on patients' cardiovascular risk outcomes. This protocol aims to outline the methods employed in a systematic review of current literature to assess whether interprofessional collaboration between GPs and pharmacists has an impact on improving cardiovascular risk outcomes among patients in the primary care setting. METHODS AND ANALYSIS: Randomised controlled trials (RCTs) will be identified through database searches, scanning reference lists of relevant studies, hand searching of key journals and citation searching of key papers. Two independent reviewers will screen studies against eligibility criteria and extract data using standardised forms. Databases including MEDLINE, EMBASE, Cochrane, CINAHL and International Pharmaceutical Abstracts, will be searched from the beginning of each database until October 2018. Primary outcome includes improvement in cardiovascular risk factors, such as hypertension, due to GP and pharmacist cooperation. Secondary outcome is to describe the different types of GP and pharmacist collaborative models of care. A narrative synthesis of findings will be presented. A meta-analysis will be performed if the data are homogenous. ETHICS AND DISSEMINATION: This study does not require ethics approval. The results of the systematic review described within this protocol will be disseminated through presentations at relevant conferences and publication in a peer-reviewed journal. The methods will be used to inform future reviews. PROSPERO REGISTRATION NUMBER: CRD42017055259.