Impact of a pharmacy-led screening and intervention in people at risk of or living with chronic kidney disease in a primary care setting: a cluster randomised trial protocol.

INTRODUCTION: Chronic kidney disease (CKD) is increasingly recognised as a growing global public health problem. Early detection and management can significantly reduce the loss of kidney function. The proposed trial aims to evaluate the impact of a community pharmacy-led intervention combining CKD screening and medication review on CKD detection and quality use of medicines (QUM) for patients with CKD. We hypothesise that the proposed intervention will enhance detection of newly diagnosed CKD cases and reduce potentially inappropriate medications use by people at risk of or living with CKD. METHODS AND ANALYSIS: This study is a multicentre, pragmatic, two-level cluster randomised controlled trial which will be conducted across different regions in Australia. Clusters of community pharmacies from geographical groups of co-located postcodes will be randomised. The project will be conducted in 122 community pharmacies distributed across metropolitan and rural areas. The trial consists of two arms: (1) Control Group: a risk assessment using the QKidney CKD risk assessment tool, and (2) Intervention Group: a risk assessment using the QKidney CKD plus Point-of-Care Testing for kidney function markers (serum creatinine and estimated glomerular filtration rate), followed by a QUM service. The primary outcomes of the study are the proportion of patients newly diagnosed with CKD at the end of the study period (12 months); and rates of changes in the number of medications considered problematic in kidney disease (number of medications prescribed at inappropriate doses based on kidney function and/or number of nephrotoxic medications) over the same period. Secondary outcomes include proportion of people on potentially inappropriate medications, types of recommendations provided by the pharmacist (and acceptance rate by general practitioners), proportion of people who were screened, referred, and took up the referral to visit their general practitioners, and economic and other patient-centred outcomes. ETHICS AND DISSEMINATION: The trial protocol has been approved by the Human Research Ethics Committee at the University of Sydney (2022/044) and the findings of the study will be presented at scientific conferences and published in peer-reviewed journal(s). TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12622000329763).

Preventing diabetes-related foot ulcers through early detection of peripheral neuropathy.

BACKGROUND: Peripheral neuropathy, peripheral arterial disease and diabetes-related foot ulcers are the most important risk factors for future amputation. Up to 50% of people with diabetes have distal symmetrical polyneuropathy as a complication of diabetes. Distal symmetrical polyneuropathy results in loss of protective sensation in the feet, increasing the risk of diabetes-related foot ulceration. OBJECTIVE: The aim of this article is to provide structured guidance for detecting diabetes-related peripheral neuropathy, appropriate referral based on risk assessment and prevention of diabetes­related foot ulceration. DISCUSSION: As a result of the often-asymptomatic nature of diabetes-related peripheral neuropathy, general practice is an ideal location for screening all adults with diabetes for loss of protective sensation. Loss of protective sensation in a person with diabetes indicates an at-risk foot. Increased frequency of foot examination, education in self-care, appropriate footwear and referral to podiatry for non­ulcerative foot problems can reduce the development of diabetes-related foot ulcers.

People with type 2 diabetes' experiences of emotional support in Australian general practice: a qualitative study.

BACKGROUND: Diabetes distress, experienced by up to 40% of people with type 2 diabetes (T2D), is the negative emotional response to the burden of living with and managing diabetes. It is associated with suboptimal glycaemia and diabetes self-management. Research indicates that people with diabetes do not recall being asked about emotional distress by healthcare professionals. AIM: To explore the experiences, needs, and expectations of people with T2D regarding emotional support received in Australian general practice. DESIGN & SETTING: Exploratory qualitative study in Victoria, Australia. METHOD: Semi-structured interviews were undertaken to explore emotional health and support received in general practice in 12 adults with T2D who primarily attend general practice. Interviews were audio-recorded, transcribed verbatim, and analysed using the framework approach. RESULTS: The following three major themes were identified: (1) Beneath the surface of diabetes care; (2) Importance of GP-patient relationship; and (3) Communication counts. Participants experienced diabetes care as focused primarily on medical management rather than the emotional aspects of living with T2D. While people's experiences of diabetes care in general practice primarily focused on physical health, the GP care beyond the presenting complaint has an essential role in identifying emotional issues and enabling support. Emotional issues were more likely to be discussed and acknowledged by the GP where there was a long-standing relationship between GP and patient. CONCLUSION: Pre-existing positive GP-patient relationships and supportive communication enable people with 2TD to raise emotional issues as part of diabetes care.

Assessing and addressing diabetes distress among adults with type 2 diabetes: An online survey of Australian general practitioners.

AIM: Diabetes distress is experienced by up to 36% of adults with type 2 diabetes. Australian type 2 diabetes guidelines recommend annual assessment of diabetes distress in general practice. This study explores general practitioners' knowledge, current practice, and factors influencing implementation of guidelines, including Person Reported Outcome Measure (PROM) use. METHODS: A cross-sectional online survey was disseminated via e-mail to 4776 Australian general practitioners listed on the Australasian Medical Publishing Company database. RESULTS: 264 (5%) surveys were returned. 75% indicated that general practitioners were the most appropriate professionals to assess diabetes distress. Sixteen percent reported asking about diabetes distress during type 2 diabetes consultations more than half the time, with 13% using a PROM more than half the time: 64% use the Kessler-10, and 1.9% use the Problem Areas in Diabetes (PAID) scale. While general practitioners had positive beliefs about the consequences of assessing and addressing diabetes distress, they also reported barriers in motivation, environment, and knowledge of guidelines. CONCLUSION: Most respondents endorsed general practitioners' role in assessing diabetes distress, but few ask about or assess diabetes distress in routine consultations. To support uptake of guideline recommendations for diabetes-specific PROM use, environmental factors, specifically time, need to be addressed.

Effect of routinely assessing and addressing depression and diabetes distress on clinical outcomes among adults with type 2 diabetes: a systematic review.

OBJECTIVES: This study examined the effect of using patient-reported outcome measures (PROMs) routinely to assess and address depressive symptoms and diabetes distress among adults with type 2 diabetes. DESIGN: A systematic review of published peer-reviewed studies. DATA SOURCES: Medline, Embase, CINAHL Complete, PsycINFO, The Cochrane Library and Cochrane Central Register of Controlled Trials were searched. ELIGIBILITY CRITERIA: Studies including adults with type 2 diabetes, published in English, from the inception of the databases to 24 February 2022 inclusive; and where the intervention included completion of a PROM of depressive symptoms and/or diabetes distress, with feedback of the responses to a healthcare professional. DATA EXTRACTION AND SYNTHESIS: Using Covidence software, screening and risk of bias assessment were conducted by two reviewers independently with any disagreements resolved by a third reviewer. RESULTS: The search identified 4512 citations, of which 163 full-text citations were assessed for eligibility, and nine studies met the inclusion criteria. Five studies involved assessment of depressive symptoms only, two studies assessed diabetes distress only, and two studies assessed both. All studies had an associated cointervention. When depressive symptoms were assessed (n=7), a statistically significant between-group difference in depressive symptoms was observed in five studies; with a clinically significant (>0.5%) between-group difference in HbA1c in two studies. When diabetes distress was assessed (n=4), one study demonstrated statistically significant difference in depressive symptoms and diabetes distress; with a clinically significant between-group difference in HbA1c observed in two studies. CONCLUSION: Studies are sparse in which PROMs are used to assess and address depressive symptoms or diabetes distress during routine clinical care of adults with type 2 diabetes. Further research is warranted to understand how to integrate PROMs into clinical care efficiently and determine appropriate interventions to manage identified problem areas. PROSPERO REGISTRATION NUMBER: CRD42020200246.

People with type 2 diabetes experiences and needs of emotional support in Australian general practice: A qualitative study.

Context: Diabetes distress is the negative emotional response to the burden of living with and managing diabetes. It is associated with sub-optimal glycemia and diabetes self-management, with up to 40% of people with type 2 diabetes experiencing diabetes distress. Australian guidelines specifically recommend using Patient Reported Outcome Measures such as Problem Areas In Diabetes (PAID) scale to assess diabetes distress and discuss sources of distress with people with diabetes. However, use of the PAID scale in Australian general practice is low. Objective: Explore the experiences of people with type 2 diabetes, their needs and expectations of emotional support in general practice, and barriers and facilitators to completing the PAID scale. Study Design: Qualitative study with semi-structured interviews conducted via Zoom or telephone. Guided by Richie's framework thematic analysis, following familiarisation with the data, an initial thematic framework was developed using inductive and deductive approach. Data were coded using the thematic framework. Setting: General practices in Victoria, Australia. Participants: Adults >18 years with type 2 diabetes who primarily attend general practice for diabetes care. Outcomes to be reported: Themes and subthemes related to experiences, needs and expectations of emotional support of people with type 2 diabetes attending general practice are reported. Results: Twelve adults with type 2 diabetes participated. Seven women and five men participated; age range from 27-79 years. Participants considered the pre-existing general practitioner (GP)-patient relationship important when exploring emotional health during diabetes care. Key themes identified that influenced experiences of care were: (1) biomedical focus of diabetes care; (2) the GP-patient relationship; (3) importance of communication. No participants recalled completing the PAID scale with their GP to assess emotional health. They believed that the PAID scale could promote an understanding from the GP about issues impacting their life beyond the biomedical aspects of diabetes. Conclusions: Our findings indicate people with type 2 diabetes have no experience of using the PAID scale during diabetes care but perceive the use of the PAID scale could improve communication with their GP due to pre-identification of emotional issues. The findings will be used to develop a tool to implement the PAID scale in general practices in Victoria, Australia.

Towards optimising chronic kidney disease detection and management in primary care: Underlying theory and protocol for technology development using an Integrated Knowledge Translation approach.

Worldwide, Chronic Kidney Disease (CKD), directly or indirectly, causes more than 2.4 million deaths annually with symptoms generally presenting late in the disease course. Clinical guidelines support the early identification and treatment of CKD to delay progression and improve clinical outcomes. This paper reports the protocol for the codesign, implementation and evaluation of a technological platform called Future Health Today (FHT), a software program that aims to optimise early detection and management of CKD in general practice. FHT aims to optimise clinical decision making and reduce practice variation by translating evidence into practice in real time and as a part of quality improvement activities. This protocol describes the co-design and plans for implementation and evaluation of FHT in two general practices invited to test the prototype over 12 months. Service design thinking has informed the design phase and mixed methods will evaluate outcomes following implementation of FHT. Through systematic application of co-design with service users, clinicians and digital technologists, FHT attempts to avoid the pitfalls of past studies that have failed to accommodate the complex requirements and dynamics that can arise between researchers and service users and improve chronic disease management through use of health information technology.

Effect of routinely assessing and addressing depression and diabetes distress using patient-reported outcome measures in improving outcomes among adults with type 2 diabetes: a systematic review protocol.

INTRODUCTION: Type 2 diabetes is a global health priority. People with diabetes are more likely to experience mental health problems relative to people without diabetes. Diabetes guidelines recommend assessment of depression and diabetes distress during diabetes care. This systematic review will examine the effect of routinely assessing and addressing depression and diabetes distress using patient-reported outcome measures in improving outcomes among adults with type 2 diabetes. METHODS AND ANALYSIS: MEDLINE, Embase, CINAHL Complete, PsycInfo, The Cochrane Library and Cochrane Central Register of Controlled Trials will be searched using a prespecified strategy using a prespecified Population, Intervention, Comparator, Outcomes, Setting and study design strategy. The date range of the search of all databases will be from inception to 3 August 2020. Randomised controlled trials, interrupted time-series studies, prospective and retrospective cohort studies, case-control studies and analytical cross-sectional studies published in peer-reviewed journals in the English language will be included. Two review authors will independently screen abstracts and full texts with disagreements resolved by a third reviewer, if required, using Covidence software. Two reviewers will undertake risk of bias assessment using checklists appropriate to study design. Data will be extracted using prespecified template. A narrative synthesis will be conducted, with a meta-analysis, if appropriate. ETHICS AND DISSEMINATION: Ethics approval is not required for this review of published studies. Presentation of results will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidance. Findings will be disseminated via peer-reviewed publication and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42020200246.

Prescribing and deprescribing in chronic kidney disease.

BACKGROUND: Chronic kidney disease (CKD) rarely occurs in isolation; multimorbidity is the norm. As a result, polypharmacy is common in people with CKD. Some medications are indicated to reduce the risk of cardiovascular disease and progression of CKD. In contrast, some medications may require dose reduction or cessation as a result of advancing stages of CKD. OBJECTIVE: The aim of this article is to describe broad principles of managing the challenges and necessities of polypharmacy in patients with CKD. DISCUSSION: Medications such as angiotensin converting enzyme inhibitors, angiotensin receptor blockers, statins and sodium-glucose co-transporter-2 inhibitors may reduce cardiovascular disease risk and/or reduce CKD progression, and their use should be balanced by likelihood of benefit. Medication cessation or dose reduction may be required to prevent medication accumulation, adverse medication events and kidney injury. Polypharmacy can be addressed with a collaborative Home Medicines Review and use of deprescribing tools, using a shared decision-making approach.

Sodium-glucose cotransporter protein-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists for type 2 diabetes: systematic review and network meta-analysis of randomised controlled trials.

OBJECTIVE: To evaluate sodium-glucose cotransporter-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists in patients with type 2 diabetes at varying cardiovascular and renal risk. DESIGN: Network meta-analysis. DATA SOURCES: Medline, Embase, and Cochrane CENTRAL up to 11 August 2020. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials comparing SGLT-2 inhibitors or GLP-1 receptor agonists with placebo, standard care, or other glucose lowering treatment in adults with type 2 diabetes with follow up of 24 weeks or longer. Studies were screened independently by two reviewers for eligibility, extracted data, and assessed risk of bias. MAIN OUTCOME MEASURES: Frequentist random effects network meta-analysis was carried out and GRADE (grading of recommendations assessment, development, and evaluation) used to assess evidence certainty. Results included estimated absolute effects of treatment per 1000 patients treated for five years for patients at very low risk (no cardiovascular risk factors), low risk (three or more cardiovascular risk factors), moderate risk (cardiovascular disease), high risk (chronic kidney disease), and very high risk (cardiovascular disease and kidney disease). A guideline panel provided oversight of the systematic review. RESULTS: 764 trials including 421 346 patients proved eligible. All results refer to the addition of SGLT-2 inhibitors and GLP-1 receptor agonists to existing diabetes treatment. Both classes of drugs lowered all cause mortality, cardiovascular mortality, non-fatal myocardial infarction, and kidney failure (high certainty evidence). Notable differences were found between the two agents: SGLT-2 inhibitors reduced admission to hospital for heart failure more than GLP-1 receptor agonists, and GLP-1 receptor agonists reduced non-fatal stroke more than SGLT-2 inhibitors (which appeared to have no effect). SGLT-2 inhibitors caused genital infection (high certainty), whereas GLP-1 receptor agonists might cause severe gastrointestinal events (low certainty). Low certainty evidence suggested that SGLT-2 inhibitors and GLP-1 receptor agonists might lower body weight. Little or no evidence was found for the effect of SGLT-2 inhibitors or GLP-1 receptor agonists on limb amputation, blindness, eye disease, neuropathic pain, or health related quality of life. The absolute benefits of these drugs vary substantially across patients from low to very high risk of cardiovascular and renal outcomes (eg, SGLT-2 inhibitors resulted in 3 to 40 fewer deaths in 1000 patients over five years; see interactive decision support tool (https://magicevidence.org/match-it/200820dist/#!/) for all outcomes. CONCLUSIONS: In patients with type 2 diabetes, SGLT-2 inhibitors and GLP-1 receptor agonists reduced cardiovascular and renal outcomes, with some differences in benefits and harms. Absolute benefits are determined by individual risk profiles of patients, with clear implications for clinical practice, as reflected in the BMJ Rapid Recommendations directly informed by this systematic review. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019153180.

Professional flash glucose monitoring and health service utilisation in type 2 diabetes: A secondary analysis of the GP-OSMOTIC study.

AIM: Professional flash glucose monitoring involves people with diabetes wearing a glucose monitor for up to two weeks, with the data downloaded by their health professional, and the information used to help guide treatment. This study describes if professional flash glucose monitoring was associated with a change in health services utilisation. METHODS: Administrative claims data from three data sources were linked to 288 participants from the GP-OSMOTIC study, a randomised controlled trial evaluating the use of professional flash glucose monitoring versus usual care in people with type 2 diabetes in primary care. Generalised linear models with the Poisson family specified and log link function were used to compare general practice consultations between the intervention and control groups at 0-6- and 6-12-month time points, with adjustment for baseline health services utilisation. RESULTS: GP consultations increased in the flash glucose monitoring group in the 6 months following initial flash glucose monitoring sensor application from a median (IQR) 6 (4,9) to 8 (5,11); (P < 0.001). Participants in the professional FGM group were 1.2 times (95 % CI 1.1-1.4 (P = 0.0014)) more likely at 6-12 months to have GP consultation visits. CONCLUSIONS: Administrative claims data identified changes in health services utilisation associated with professional flash glucose monitoring, despite minimal changes in glycaemic control.

Future Health Today: codesign of an electronic chronic disease quality improvement tool for use in general practice using a service design approach.

OBJECTIVE: To codesign an electronic chronic disease quality improvement tool for use in general practice. DESIGN: Service design employing codesign strategies. SETTING: General practice. PARTICIPANTS: Seventeen staff (general practitioners, nurses and practice managers) from general practice in metropolitan Melbourne and regional Victoria and five patients from metropolitan Melbourne. INTERVENTIONS: Codesign sessions with general practice staff, using a service design approach, were conducted to explore key design criteria and functionality of the audit and feedback and clinical decision support tools. Think aloud interviews were conducted in which participants articulated their thoughts of the resulting Future Health Today (FHT) prototype as they used it. One codesign session was held with patients. Using inductive and deductive coding, content and thematic analyses explored the development of a new technological platform and factors influencing implementation of the platform. RESULTS: Participants identified that the prototype needed to work within their existing workflow to facilitate automated patient recall and track patients with or at-risk of specific conditions. It needed to be simple, provide visual snapshots of information and easy access to relevant guidelines and facilitate quality improvement activities. Successful implementation may be supported by: accuracy of the algorithms in FHT and data held in the practice; the platform supporting planned and spontaneous interactions with patients; the ability to hide tools; links to Medicare Benefits Schedule; and prefilled management plans. Participating patients supported the use of the platform in general practice. They suggested that use of the platform demonstrates a high level of patient care and could increase patient confidence in health practitioners. CONCLUSION: Study participants worked together to design a platform that is clear, simple, accurate and useful and that sits within any given general practice setting. The resulting FHT platform is currently being piloted in general practices and will continue to be refined based on user feedback.