An exploratory randomised trial investigating feasibility, potential impact and cost effectiveness of link workers for people living with multimorbidity attending general practices in deprived urban communities.

BACKGROUND: Social prescribing link workers are non-health or social care professionals who connect people with psychosocial needs to non-clinical community supports. They are being implemented widely, but there is limited evidence for appropriate target populations or cost effectiveness. This study aimed to explore the feasibility, potential impact on health outcomes and cost effectiveness of practice-based link workers for people with multimorbidity living in deprived urban communities. METHODS: A pragmatic exploratory randomised trial with wait-list usual care control and blinding at analysis was conducted during the COVID 19 pandemic (July 2020 to January 2021). Participants had two or more ongoing health conditions, attended a general practitioner (GP) serving a deprived urban community who felt they may benefit from a one-month practice-based social prescribing link worker intervention.. Feasibility measures were recruitment and retention of participants, practices and link workers, and completion of outcome data. Primary outcomes at one month were health-related quality of life (EQ-5D-5L) and mental health (HADS). Potential cost effectiveness from the health service perspective was evaluated using quality adjusted life years (QALYs), based on conversion of the EQ-5D-5L and ICECAP-A capability index to utility scoring. RESULTS: From a target of 600, 251 patients were recruited across 13 general practices. Randomisation to intervention (n = 123) and control (n = 117) was after baseline data collection. Participant retention at one month was 80%. All practices and link workers (n = 10) were retained for the trial period. Data completion for primary outcomes was 75%. There were no significant differences identified using mixed effects regression analysis in EQ-5D-5L (MD 0.01, 95% CI -0.07 to 0.09) or HADS (MD 0.05, 95% CI -0.63 to 0.73), and no cost effectiveness advantages. A sensitivity analysis that considered link workers operating at full capacity in a non-pandemic setting, indicated the probability of effectiveness at the €45,000 ICER threshold value for Ireland was 0.787 using the ICECAP-A capability index. CONCLUSIONS: While the trial under-recruited participants mainly due to COVID-19 restrictions, it demonstrates that robust evaluations and cost utility analyses are possible. Further evaluations are required to establish cost effectiveness and should consider using the ICE-CAP-A wellbeing measure for cost utility analysis. REGISTRATION: This trial is registered on ISRCTN. TITLE: Use of link workers to provide social prescribing and health and social care coordination for people with complex multimorbidity in socially deprived areas. TRIAL ID: ISRCTN10287737. Date registered 10/12/2019. Link: https://www.isrctn.com/ISRCTN10287737.

The effectiveness and cost of integrating pharmacists within general practice to optimize prescribing and health outcomes in primary care patients with polypharmacy: a systematic review.

BACKGROUND: Polypharmacy and associated potentially inappropriate prescribing (PIP) place a considerable burden on patients and represent a challenge for general practitioners (GPs). Integration of pharmacists within general practice (herein 'pharmacist integration') may improve medications management and patient outcomes. This systematic review assessed the effectiveness and costs of pharmacist integration. METHODS: A systematic search of ten databases from inception to January 2021 was conducted. Studies that evaluated the effectiveness or cost of pharmacist integration were included. Eligible interventions were those that targeted medications optimization compared to usual GP care without pharmacist integration (herein 'usual care'). Primary outcomes were PIP (as measured by PIP screening tools) and number of prescribed medications. Secondary outcomes included health-related quality of life, health service utilization, clinical outcomes, and costs. Randomised controlled trials (RCTs), non-RCTs, interrupted-time-series, controlled before-after trials and health-economic studies were included. Screening and risk of bias using Cochrane EPOC criteria were conducted by two reviewers independently. A narrative synthesis and meta-analysis of outcomes where possible, were conducted; the certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation approach. RESULTS: In total, 23 studies (28 full text articles) met the inclusion criteria. In ten of 11 studies, pharmacist integration probably reduced PIP in comparison to usual care (moderate certainty evidence). A meta-analysis of number of medications in seven studies reported a mean difference of -0.80 [-1.17, -0.43], which indicated pharmacist integration probably reduced number of medicines (moderate certainty evidence). It was uncertain whether pharmacist integration improved health-related quality of life because the certainty of evidence was very low. Twelve health-economic studies were included; three investigated cost effectiveness. The outcome measured differed across studies limiting comparisons and making it difficult to make conclusions on cost effectiveness. CONCLUSIONS: Pharmacist integration probably reduced PIP and number of medications however, there was no clear effect on other patient outcomes; and while interventions in a small number of studies appeared to be cost-effective, further robust, well-designed cluster RCTs with economic evaluations are required to determine cost-effectiveness of pharmacist integration. TRIAL REGISTRATION: CRD42019139679.

Cost-effectiveness of metabolic surgery for the treatment of type 2 diabetes and obesity: a systematic review of economic evaluations.

AIM: To systematically identify and appraise the international literature on the cost-effectiveness of metabolic surgery for the treatment of comorbid type 2 diabetes (T2D) and obesity. METHODS: A systematic search was conducted in electronic databases and grey literature sources up to 20 January 2021. Economic evaluations in a T2D population or a subpopulation with T2D were eligible for inclusion. Screening, data extraction, critical appraisal of methodological quality (Consensus Health Economic Criteria list) and assessment of transferability (International Society for Pharmacoeconomics and Outcomes Research questionnaire) were undertaken in duplicate. The incremental cost-effectiveness ratio (ICER) was the main outcome. Costs were reported in 2020 Irish Euro. Cost-effectiveness was interpreted using willingness-to-pay (WTP) thresholds of €20,000 and €45,000/quality-adjusted life year (QALY). Due to heterogeneity arising from various sources, a narrative synthesis was undertaken. RESULTS: Thirty studies across seventeen jurisdictions met the inclusion criteria; 16 specifically in a T2D population and 14 in a subpopulation with T2D. Overall, metabolic surgery was found to be cost-effective or cost-saving. Where undertaken, the results were robust to sensitivity and scenario analyses. Of the 30 studies included, 15 were considered high quality. Identified limitations included limited long-term follow-up data and uncertainty regarding the utility associated with T2D remission. CONCLUSION: Published high-quality studies suggest metabolic surgery is a cost-effective or cost-saving intervention. As the prevalence of obesity and obesity-related diseases increases worldwide, significant investment and careful consideration of the resource requirements needed for metabolic surgery programmes will be necessary to ensure that service provision is adequate to meet demand.

What is the impact of multimorbidity on out-of-pocket healthcare expenditure among community-dwelling older adults in Ireland? A cross-sectional study.

OBJECTIVES: Individuals with multimorbidity use more health services and take more medicines. This can lead to high out-of-pocket (OOP) healthcare expenditure. This study, therefore, aimed to assess the association between multimorbidity (two or more chronic conditions) and OOP healthcare expenditure in a nationally representative sample of adults aged 50 years or over. DESIGN: Cross-sectional analysis of data collected in 2016 from wave 4 of The Irish Longitudinal Study on Ageing.SettingIreland.ParticipantsCommunity-dwelling adults aged 50 years and over.MethodA generalised linear model with log-link and gamma distributed errors was fitted to assess the association between multimorbidity and OOP healthcare expenditure (including general practitioner, emergency department, outpatients, specialist consultations, hospital admissions, home care and prescription drugs). RESULTS: Overall, 3453 (58.5%) participants had multimorbidity. Among those with any OOP healthcare expenditure, individuals with multimorbidity spent more on average per annum (€806.8 for two conditions, €885.8 for three or more conditions), than individuals with no conditions (€580.3). Pharmacy-dispensed medicine expenditure was the largest component of expenditure. People with multimorbidity on average spent more of their equivalised household income on healthcare (7.1% for two conditions, 9.7% for three or more conditions), than people with no conditions (5.0%). A strong positive association was found between number of conditions and OOP healthcare expenditure (p<0.001) and between having private health insurance and OOP healthcare expenditure (p<0.001). A strong negative association was found between eligibility for free primary/hospital care and heavily subsidised medicines and OOP healthcare expenditure (p<0.001). CONCLUSIONS: This study suggests that having multimorbidity in Ireland increases OOP healthcare expenditure, which is problematic for those with more conditions who have lower incomes. This highlights the need for this financial burden to be considered when designing healthcare/funding systems to address multimorbidity, so that access to essential healthcare can be maximised for those with greatest need.

Disparities in Oral Nutritional Supplement Usage and Dispensing Patterns across Primary Care in Ireland: ONSPres Project.

When treating malnutrition, oral nutritional supplements (ONSs) are advised when optimising the diet is insufficient; however, ONS usage and user characteristics have not been previously analysed. A retrospective secondary analysis was performed on dispensed pharmacy claim data for 14,282 anonymised adult patients in primary care in Ireland in 2018. Patient sex, age, residential status, ONS volume (units) and ONS cost (EUR) were analysed. The categories of 'Moderate' (<75th centile), 'High' (75th-89th centile) and 'Very High' ONS users (≥90th centile) were created. The analyses among groups utilised t-tests, Mann-Whitney U tests and chi-squared tests. This cohort was 58.2% female, median age was 76 years, with 18.7% in residential care. The most frequently dispensed ONS type was very-high-energy sip feeds (45% of cohort). Younger males were dispensed more ONSs than females (<65 years: median units, 136 vs. 90; p < 0.01). Patients living independently were dispensed half the volume of those in residential care (112 vs. 240 units; p < 0.01). 'Moderate' ONS users were dispensed a yearly median of 84 ONS units (median cost, EUR 153), 'High' users were dispensed 420 units (EUR 806) and 'Very High' users 892 yearly units (EUR 2402; p < 0.01). Further analyses should focus on elucidating the reasons for high ONS usage in residential care patients and younger males.

Healthcare professionals' perceptions of malnutrition management and oral nutritional supplement prescribing in the community: A qualitative study.

BACKGROUND & AIM: Protein-energy malnutrition is under-recognised in the community despite being common in older adults due to physiological and social changes which are often compounded by chronic disease. This qualitative study aimed to explore the opinions of healthcare professionals (HCPs) working in the primary care and community settings about the management of malnutrition and the prescription of oral nutritional supplements (ONS), often included in the treatment of malnutrition. METHODS: Twelve healthcare professional (HCP) focus groups with 75 participants were conducted: community dietitians (n = 17), registered dietitians working in industry (n = 5), community and residential care nurses (n = 22), physiotherapists (n = 12), pharmacists (n = 9), occupational therapists (n = 6) and speech and language therapists (n = 4). Focus group discussions were audio-recorded and transcribed verbatim. The data were coded and analysed using thematic analysis and key themes with illustrative quotes extracted are presented. RESULTS: Similar views on malnutrition management existed across professions. 'Gaps in Primary Care Management' was the first key theme wherein HCPs identified limitations in malnutrition management in the community. Barriers included limited or no dietetic services available in primary care and poor communication between general practitioners and wider primary care team members which resulted in inappropriate or delayed treatment. The second key theme, 'Challenges with ONS use in the Community', encapsulated several issues HCPs experienced with ONS usage including inappropriate prescribing and lack of monitoring of treatment goals. Conflicts of interest regarding dietitians working in industry assessing and treating older adults in residential care settings was highlighted by participants. CONCLUSIONS: This study highlights that more emphasis is needed to identify patients when they are at risk of malnutrition to avoid advanced or severe malnutrition presentations currently seen. Community dietitians for older people are required to address many of the issues raised including the need for awareness, education and training, resources, and malnutrition care pathway structures.

Link workers providing social prescribing and health and social care coordination for people with multimorbidity in socially deprived areas (the LinkMM trial): protocol for a pragmatic randomised controlled trial.

INTRODUCTION: Link workers are non-health or social care professionals based in primary care who support people to develop and achieve a personalised set of health and social goals by engaging with community resources. Link workers have been piloted in areas of deprivation, but there remains insufficient evidence to support their effectiveness. Multimorbidity is increasing in prevalence, but there are limited evidence-based interventions. This paper presents the protocol for a randomised controlled trial (RCT) that will test the effectiveness of link workers based in general practices in deprived areas in improving health outcomes for people with multimorbidity. METHODS AND ANALYSIS: The protocol presents the proposed pragmatic RCT, involving 10 general practitioner (GP) practices and 600 patients. Eligible participants will be community dwelling adults with multimorbidity (≥two chronic conditions) identified as being suitable for referral to a practice-based link worker. Following baseline data collection, the patients will be randomised into intervention group that will meet the link worker over a1-month period, or a 'wait list' control that will receive usual GP care. Primary outcomes are health-related quality of life as assessed by EQ-5D-5L and mental health assessed by Hospital Anxiety and Depression Scale. Secondary outcomes are based on the core outcome set for multimorbidity. Data will be collected at baseline and on intervention completion at 1 month using questionnaires self-completed by participants and GP records. Parallel process and economic analyses will be conducted to explore participants' experiences and examine cost-effectiveness of the link worker intervention. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Irish College of General Practitioners Ethics Committee. The findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN10287737;Pre-results.

Characteristics and determinants of high volume dispensing in long-term oral nutritional supplement users in primary care: a secondary analysis.

BACKGROUND: Oral nutritional supplements (ONS) are recommended for patients who are malnourished or at risk of malnutrition. Appropriate ONS prescribing requires regular monitoring to assess its continued requirement. Previous research identified long-term ONS prescriptions (>6 months) without review, with 70% of these influenced by social factors. AIM: To investigate the characteristics of long-term ONS users in Ireland and the determinants of larger volumes of ONS dispensing. DESIGN & SETTING: Secondary analysis of anonymous dispensed pharmacy claims data of patients dispensed standard ONS for 12 consecutive months in 2018 (n = 912). METHOD: Factors showing significant (P<0.05) univariate associations with above the median consumption of ONS units were entered into a multivariable model. RESULTS: Median age was 76 (range 18 to 101) years, with 66.9% of the sample being ≥65 years. Almost 70% of the samples were on polypharmacy (45.6%; ≥5 medications) or excessive polypharmacy (21.5%; ≥10 medications). Younger age and being on polypharmacy for drugs having an effect on the central nervous system (CNS) were significantly associated with being dispensed more ONS units in univariate and multivariate analysis. Those patients in the age range 18 to 44 were 2.5 fold more likely to be prescribed more ONS units (odds ratio [OR] 2.5; 95% confidence interval [CI] 1.5 to 4.3; P<0.001). Patients using CNS drugs or on CNS polypharmacy were more likely to be prescribed more ONS units (ORs 1.2 and 2.4; 95% CI 0.9 to 1.4 and 1.3 to 4.4 respectively; P = 0.029). CONCLUSION: Older age and polypharmacy characterise long-term ONS users in this study. Younger age and CNS medication polypharmacy are predictors of more ONS units prescribed over a year.

Protocol for a mixed methods process evaluation of the LinkMM randomised controlled trial "Use of link workers to provide social prescribing and health and social care coordination for people with complex multimorbidity in socially deprived areas".

Background  Multimorbidity, defined as two or more chronic conditions is increasing in prevalence and is associated with increased health care use, fragmented care and poorer health outcomes. Link workers are non-health or social care professionals who support people to connect with resources in their community to improve their well-being, a process commonly referred to as social prescribing. The use of link workers in primary care may be an effective intervention in helping those with long-term conditions manage their illness and improve health and well-being, but the evidence base in limited. The LinkMM study is a randomised controlled trial of the effectiveness of link workers based in primary care, providing social prescribing and health and social care coordination for people with multimorbidity. The aim of the LinkMM process evaluation is to investigate the implementation of the link worker intervention, mechanisms of impact and influence of the specific context on these, as per the Medical Research Council framework, using quantitative and qualitative methods. Methods  Quantitative data will be gathered from a number of sources including researcher logbooks, participant baseline questionnaires, client management database, and will be analysed using descriptive statistics. Semi structured interviews with participants will investigate their experiences of the intervention. Interviews with link workers, practices and community stakeholders will explore how the intervention was implemented and barriers and facilitators to this. Thematic analysis of interview transcripts will be conducted. Discussion  The process evaluation of the LinkMM trial will provide important information allowing a more in-depth understanding of how the intervention worked and lessons for future wider scale implementation.

The experience of financial burden for people with multimorbidity: A systematic review of qualitative research.

BACKGROUND: Multimorbidity prevalence is increasing globally. People with multimorbidity have higher health care costs, which can create a financial burden. OBJECTIVE: To synthesize qualitative research exploring experience of financial burden for people with multimorbidity. SEARCH STRATEGY: Six databases were searched in May 2019. A grey literature search and backward and forward citation checking were also conducted. INCLUSION CRITERIA: Studies were included if they used a qualitative design, conducted primary data collection, included references to financial burden and had at least one community-dwelling adult participant with two or more chronic conditions. DATA EXTRACTION AND SYNTHESIS: Screening and critical appraisal were conducted by two reviewers independently. One reviewer extracted data from the results section; this was checked by a second reviewer. GRADE-CERQual was used to summarize the certainty of the evidence. Data were analysed using thematic synthesis. MAIN RESULTS: Forty-six studies from six continents were included. Four themes were generated: the high costs people with multimorbidity experience, the coping strategies they use to manage these costs, and the negative effect of both these on their well-being. Health insurance and government supports determine the manageability and level of costs experienced. DISCUSSION: Financial burden has a negative effect on people with multimorbidity. Continuity of care and an awareness of the impact of financial burden of multimorbidity amongst policymakers and health care providers may partially address the issue. PATIENT OR PUBLIC CONTRIBUTION: Results were presented to a panel of people with multimorbidity to check whether the language and themes 'resonated' with their experiences.

Evaluation of the General Practice Pharmacist (GPP) intervention to optimise prescribing in Irish primary care: a non-randomised pilot study.

OBJECTIVE: Limited evidence suggests integration of pharmacists into the general practice team could improve medicines management for patients, particularly those with multimorbidity and polypharmacy. This study aimed to develop and assess the feasibility of an intervention involving pharmacists, working within general practices, to optimise prescribing in Ireland. DESIGN: Non-randomised pilot study. SETTING: Primary care in Ireland. PARTICIPANTS: Four general practices, purposively sampled and recruited to reflect a range of practice sizes and demographic profiles. INTERVENTION: A pharmacist joined the practice team for 6 months (10 hours/week) and undertook medication reviews (face to face or chart based) for adult patients, provided prescribing advice, supported clinical audits and facilitated practice-based education. OUTCOME MEASURES: Anonymised practice-level medication (eg, medication changes) and cost data were collected. Patient-reported outcome measure (PROM) data were collected on a subset of older adults (aged ≥65 years) with polypharmacy using patient questionnaires, before and 6 weeks after medication review by the pharmacist. RESULTS: Across four practices, 786 patients were identified as having 1521 prescribing issues by the pharmacists. Issues relating to deprescribing medications were addressed most often by the prescriber (59.8%), compared with cost-related issues (5.8%). Medication changes made during the study equated to approximately €57 000 in cost savings assuming they persisted for 12 months. Ninety-six patients aged ≥65 years with polypharmacy were recruited from the four practices for PROM data collection and 64 (66.7%) were followed up. There were no changes in patients' treatment burden or attitudes to deprescribing following medication review, and there were conflicting changes in patients' self-reported quality of life. CONCLUSIONS: This non-randomised pilot study demonstrated that an intervention involving pharmacists, working within general practices is feasible to implement and has potential to improve prescribing quality. This study provides rationale to conduct a randomised controlled trial to evaluate the clinical and cost-effectiveness of this intervention.

Quality, scope and reporting standards of randomised controlled trials in Irish Health Research: an observational study.

BACKGROUND: Despite efforts to improve the accuracy and transparency of the design, conduct, and reporting of randomised controlled trials (RCTs), deficiencies remain. Such deficiencies contribute to significant, avoidable waste of health research investment and impede reproducibility. This study aimed to synthesise and critically analyse changes over time in the conduct and reporting of internationally published evidence on patient and/or population health-oriented RCTs conducted in one country. METHODS: This observational study drew on systematic review methods. We searched six databases for published RCTs (database inception to December 2018) where ≥ 80% of participants were recruited in the Republic of Ireland. RCTs of interventions targeted at patients, providers and/or policy makers intended to improve health, healthcare or health research were included. For each study, screening, data extraction and methodological quality appraisal were conducted by one member of the author team. RESULTS: From 17,560 titles and abstracts, 752 unique RCTs were published in 745 papers between 1968 and 2018, with a steady year-on-year increase since 1968. The number of participants was in the range of 2-8628. The majority were parallel design (86%) and classified as treatment evaluation. Of the 418 RCTs published since the introduction of mandatory clinical trial registration by the International Committee of Medical Journal Editors in 2005, 32% (n = 134) provided a trial registration number. This increased to 47% when taking studies published between 2013 and 2018 (n = 232). Since the 1996 publication of the CONSORT statement, 16% of included RCTs made specific reference to a standardised reporting guideline and this increased to 31% for more recent studies published between 2013 and 2018. Overall, 7% (n = 53) of studies referred to a published study protocol, increasing to 20% for studies published between 2013 and 2018. CONCLUSION: Evidence from this single-country study of RCTs published in the international literature suggests that both the number overall, the number registered and the number referencing reporting guidelines have increased steadily over time. Despite widespread endorsement of reporting standards, reporting of RCTs remains suboptimal in domains such as compliance with the CONSORT statement and prospective trial registration. Researchers, funders and journal editors, nationally and internationally, should continue to focus on improving reporting and examining avoidable waste of health research investment.

Barriers and facilitators perceived by women while homeless and pregnant in accessing antenatal and or postnatal healthcare: A qualitative evidence synthesis.

Evidence indicates that homelessness is increasing within Europe and the United States (US), particularly for women. Pregnancy rates among homeless women are exceptionally high compared to their housed counterparts and homeless women engage poorly with antenatal care. The aim of this review is to explore the barriers and facilitators perceived by homeless women, while pregnant, or within six weeks postpartum in accessing antenatal and/or postnatal healthcare. A qualitative systematic review and synthesis was conducted. Key words and search terms were derived using the SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, Research type) framework. Titles and abstracts were screened in accordance with inclusion and exclusion criteria. The methodological quality of included papers was assessed using criteria described by the Critical Appraisal Skills Programme (CASP) with data analysis using thematic synthesis. Two primary linked themes were generated: (a) lack of person-centred care; (b) complexity of survival. At an organisational level, a fragmented health service and accessibility to the health system were barriers, and resulted in poor person-centred care. At a clinical level, attitude & treatment from healthcare providers together with health knowledge all combined to illustrate poor person-centred care as barriers to homeless women accessing antenatal/postnatal healthcare. Sub-themes associated with complexity of survival included: disillusion with life, distrust of services, competing lifestyle demands and support and relationships. The findings of this review highlight that poor engagement may be partly explained by the complex interplay between both the healthcare system (person-centred care) and the individual (complexity of survival). Future services should be delivered in a way that recognises homeless people's complex and diverse needs, and should be reconfigured in order to try to meet them, through decreasing fragmentation of health services and staff training.

The experience of financial burden for patients with multimorbidity: A protocol for a systematic review of qualitative research.

Introduction: Multimorbidity is increasingly important due to its high disease burden, prevalence and related high healthcare utilisation. For patients, there is also a high financial burden due to direct and indirect costs arising from their multimorbidity. It is unclear how this financial burden affects patients. This study aims to synthesise qualitative evidence exploring the experience of financial burden from the perspective of patients with multimorbidity. Methods: The review will be reported using the ENTREQ guidelines. A systematic search of Lilacs, PubMed, CINAHL, EMBASE, PsycINFO, and Applied Social Sciences Index and Abstracts will be conducted using a predefined search strategy. A search of fourteen pre-specified websites will be conducted for grey literature. Forward and backward citation checking of included studies will be conducted also. Studies will be included if they contain primary qualitative research and reference the experience of financial burden from the perspective of adult (≥ 18 years) community dwelling patients with multimorbidity. Studies from any country and in any language will be included. Titles and abstracts of search results will be screened; if a study appears relevant, then full-texts will be screened for eligibility. Study characteristics of included articles will be extracted. Study quality will be evaluated using the critical appraisal skills programme (CASP) checklist for qualitative research. These three processes will be carried out by two reviewers independently. Thematic-synthesis will be used to analyse data. This will be carried out by one reviewer and cross-checked by a second reviewer. The GRADE CERQual approach will be used to assess the overall confidence in the evidence. Discussion: This review will identify evidence on the experiences of financial burden for patients with multimorbidity and forms part of a project to support consideration of financial burden for patients in the development of clinical guidelines in Ireland. PROSPERO registration number: CRD42019135284.

The effectiveness of integrating clinical pharmacists within general practice to optimise prescribing and health outcomes in primary care patients with polypharmacy: A protocol for a systematic review.

Introduction: Coordinating prescribing for patients with polypharmacy is a challenge for general practitioners. Pharmacists may improve management and outcomes for patients with polypharmacy. This systematic review aims to examine the clinical and cost-effectiveness of pharmacist interventions to optimise prescribing and improve health outcomes in patients with polypharmacy in primary care settings.  Methods: The review will be reported using the PRISMA guidelines. A comprehensive search of 10 databases from inception to present, with no language restrictions will be conducted. Studies will be included where they evaluate the clinical or cost-effectiveness of a clinical pharmacist in primary care on potentially inappropriate prescriptions using validated indicators and number of medicines. Secondary outcomes will include health related quality of life measures, health service utilisation, clinical outcomes and data relating to cost effectiveness. Randomised controlled trials, non-randomised controlled trials, controlled before-after, interrupted-time-series and health economic studies will be eligible for inclusion.  Titles, abstracts and full texts will be screened for inclusion by two reviewers. Data will be extracted using a standard form. Risk of bias in all included studies will be assessed using the Effective Practice and Organisation of Care (EPOC) criteria. Economic studies will be assessed using the Consensus Health Economic Criteria (CHEC) list as per the Cochrane Handbook for critical appraisal of methodological quality. A narrative synthesis will be performed, and the certainty of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria. Where data support quantitative synthesis, a meta-analysis will be performed. Discussion: This systematic review will give an overview of the effectiveness of pharmacist interventions to improve prescribing and health outcomes in a vulnerable patient group. This will provide evidence to policy makers on strategies involving clinical pharmacists integrated within general practice, to address issues which arise in polypharmacy and multimorbidity.  PROSPERO Registration:  CRD42019139679 (28/08/19).

Core Outcome Set for Trials Aimed at Improving the Appropriateness of Polypharmacy in Older People in Primary Care.

OBJECTIVES: To develop a core outcome set (COS) for use in effectiveness trials of interventions aiming to improve the appropriateness of polypharmacy in older people in primary care. DESIGN: Standard COS development methodology was followed, comprising identification of outcomes of studies from an update of a Cochrane systematic review and previously collected qualitative data and an online Delphi consensus exercise involving three rounds. PARTICIPANTS: An international panel of 160 stakeholders comprising 120 healthcare experts and a public participant panel of 40 older people. MEASUREMENTS: Outcomes identified from studies included in the Cochrane review and secondary analysis of previously collected qualitative data were scored on a 9-point Likert scale using the GRADE scoring system anchored at 1 (not important) and 9 (critical). Consensus criteria for the COS were defined as 70% or more of participants scoring the outcome as critical and 15% or fewer scoring the outcome as not important. RESULTS: Twenty-nine outcomes identified from the Cochrane review and existing qualitative data were included in the Delphi exercise. The final COS comprised 16 outcomes. The 7 highest-ranked outcomes were serious adverse drug reactions, medication appropriateness, falls, medication regimen complexity, quality of life, mortality, and medication side effects. CONCLUSION: A COS for interventions aiming to improve the appropriateness of polypharmacy for older people in primary care has been developed. Future work will focus on identifying appropriate tools to measure.

REDUCING POTENTIALLY INAPPROPRIATE PRESCRIBING FOR OLDER PEOPLE IN PRIMARY CARE: COST-EFFECTIVENESS OF THE OPTI-SCRIPT INTERVENTION.

OBJECTIVES: This study examines the cost-effectiveness of the OPTI-SCRIPT intervention on potentially inappropriate prescribing in primary care. METHODS: Economic evaluation, using incremental cost-effectiveness and cost utility analyses, conducted alongside a cluster randomized controlled trial of twenty-one general practices and 196 patients, to compare a multifaceted intervention with usual practice in primary care in Ireland. Potentially inappropriate prescriptions (PIPs) were determined by a pharmacist. Incremental costs, PIPs, and quality-adjusted life-years (QALYs) at 12-month follow-up were estimated using multilevel regression. Uncertainty was explored using cost-effectiveness acceptability curves. RESULTS: The intervention was associated with a nonsignificant mean cost increase of €407 (95 percent CIs, -357-1170), a significant mean reduction in PIPs of 0.379 (95 percent CI, 0.092-0.666), and a nonsignificant mean increase in QALYs of 0.013 (95 percent CIs, -0.016-0.042). The incremental cost per PIP avoided was €1,269 (95 percent CI, -1400-6302) and the incremental cost per QALY gained was €30,535 (95 percent CI, -334,846-289,498). The probability of the intervention being cost-effective was 0.602 at a threshold value of €45,000 per QALY gained and was at least 0.845 at threshold values of €2,500 per PIP avoided and higher. CONCLUSIONS: While the OPTI-SCRIPT intervention was effective in reducing potentially inappropriate prescribing in primary care in Ireland, our findings highlight the uncertainty with respect to its cost-effectiveness. Further studies are required to explore the health and economic implications of interventions targeting potentially inappropriate prescribing.

Supporting prescribing in older people with multimorbidity and significant polypharmacy in primary care (SPPiRE): a cluster randomised controlled trial protocol and pilot.

BACKGROUND: Multimorbidity, defined as the presence of at least two chronic conditions, becomes increasingly common in older people and is associated with poorer health outcomes and significant polypharmacy. The National Institute for Clinical Excellence (NICE) recently published a multimorbidity guideline that advises providing an individualised medication review for all people prescribed 15 or more repeat medicines. This study incorporates this guideline and aims to assess the effectiveness of a complex intervention designed to support general practitioners (GPs) to reduce potentially inappropriate prescribing and consider deprescribing in older people with multimorbidity and significant polypharmacy in Irish primary care. METHODS: This study is a cluster randomised controlled trial, involving 30 general practices and 450 patients throughout Ireland. Practices will be eligible to participate if they have at least 300 patients aged 65 years and over on their patient panel and if they use either one of the two predominant practice management software systems in use in Ireland. Using a software patient finder tool, practices will identify and recruit patients aged 65 years and over, who are prescribed at least 15 repeat medicines. Once baseline data collection is complete, practices will be randomised using minimisation by an independent third party to either intervention or control. Given the nature of the intervention, it is not possible to blind participants or study personnel. GPs in intervention practices will receive login details to a website where they will access training videos and a template for conducting an individualised structured medication review, which they will undertake with each of their included patients. Control practices will deliver usual care over the 6-month study period. Primary outcome measures pertain to the individual patient level and are the proportion of patients with any PIP and the number of repeat medicines. DISCUSSION: Disease-specific approaches in multimorbidity may be inappropriate and result in fragmented and poorly co-ordinated care. This pragmatic study is evaluating a complex intervention that is relevant across multiple conditions and addresses potential concerns around medicines safety in this vulnerable group of patients. The potential for system-wide implementation will be explored with a parallel mixed methods process evaluation. TRIAL REGISTRATION: ISRCTN: 12752680 , Registered 20 October 2016.

A process evaluation of a cluster randomised trial to reduce potentially inappropriate prescribing in older people in primary care (OPTI-SCRIPT study).

BACKGROUND: The OPTI-SCRIPT cluster randomised controlled trial (RCT) found that a three-phase multifaceted intervention including academic detailing with a pharmacist, GP-led medicines reviews, supported by web-based pharmaceutical treatment algorithms, and tailored patient information leaflets, was effective in reducing potentially inappropriate prescribing (PIP) in Irish primary care. We report a process evaluation exploring the implementation of the intervention, the experiences of those participating in the study and lessons for future implementation. METHODS: The OPTI-SCRIPT trial included 21 GP practices and 196 patients. The process evaluation used mixed methods. Quantitative data were collected from all GP practices and semi-structured interviews were conducted with GPs from intervention and control groups, and a purposive sample of patients from the intervention group. All interviews were transcribed verbatim and analysed using a thematic analysis. RESULTS: Despite receiving a standardised academic detailing session, intervention delivery varied among GP practices. Just over 70 % of practices completed medicines review as recommended with the patient present. Only single-handed practices conducted reviews without patients present, highlighting the influence of practice characteristics and resources on variation. Medications were more likely to be completely stopped or switched to another more appropriate medication when reviews were conducted with patients present. The patient information leaflets were not used by any of the intervention practices. Both GP (32 %) and patient (40 %) recruitment rates were modest. For those who did participate, overall, the experience was positively viewed, with GPs and patients referring to the value of medication reviews to improve prescribing and reduce unnecessary medications. Lack of time in busy GP practices and remuneration were identified as organisational barriers to future implementation. CONCLUSIONS: The OPTI-SCRIPT intervention was positively viewed by both GPs and patients, both of whom valued the study's objectives. Patient information leaflets were not a successful component of the intervention. Academic detailing and medication reviews are important components in changing PIP, and having patients present during the review process seems to be a more effective approach for decreasing PIP. TRIAL REGISTRATION: Current controlled trials ISRCTN41694007 . Registered on 21 March 2012.

Effectiveness of medicines review with web-based pharmaceutical treatment algorithms in reducing potentially inappropriate prescribing in older people in primary care: a cluster randomized trial (OPTI-SCRIPT study protocol).

BACKGROUND: Potentially inappropriate prescribing in older people is common in primary care and can result in increased morbidity, adverse drug events, hospitalizations and mortality. In Ireland, 36% of those aged 70 years or over received at least one potentially inappropriate medication, with an associated expenditure of over €45 million.The main objective of this study is to determine the effectiveness and acceptability of a complex, multifaceted intervention in reducing the level of potentially inappropriate prescribing in primary care. METHODS/DESIGN: This study is a pragmatic cluster randomized controlled trial, conducted in primary care (OPTI-SCRIPT trial), involving 22 practices (clusters) and 220 patients. Practices will be allocated to intervention or control arms using minimization, with intervention participants receiving a complex multifaceted intervention incorporating academic detailing, medicines review with web-based pharmaceutical treatment algorithms that provide recommended alternative treatment options, and tailored patient information leaflets. Control practices will deliver usual care and receive simple patient-level feedback on potentially inappropriate prescribing. Routinely collected national prescribing data will also be analyzed for nonparticipating practices, acting as a contemporary national control. The primary outcomes are the proportion of participant patients with potentially inappropriate prescribing and the mean number of potentially inappropriate prescriptions per patient. In addition, economic and qualitative evaluations will be conducted. DISCUSSION: This study will establish the effectiveness of a multifaceted intervention in reducing potentially inappropriate prescribing in older people in Irish primary care that is generalizable to countries with similar prescribing challenges. TRIAL REGISTRATION: Current controlled trials ISRCTN41694007.