Clinical Guidance Recommends Research Articles

Barriers and enablers to shared decision-making in assessment and management of risk: A qualitative interview study with people using mental health services

The assessment and management of risk are fundamental to mental health care provision and are considered high-priority tasks by professionals worldwide. Clinical guidance recommends for risk to be identified and managed collaboratively with the individual, but studies indicate that this may not be happening in practice. The aim of this study was to identify the barriers and enablers to collaborative risk assessment and management based on shared decision-making from service users’ perspectives. A qualitative approach using semi‐structured interviews was employed. The Theoretical Domains Framework for behaviour change, which consists of fourteen theoretical domains that have been found to influence behaviour, informed data collection and analysis. Thirteen service users living with severe mental illness took part in an interview. The majority of participants reported not having been involved in the identification of their risk and most were unaware of the information included in their risk management plan. Perceived barriers to involvement were power dynamics between professionals and service users, difficulty talking about sensitive risk topics, and the emotional impact of engaging in these discussions. Perceived enabling factors for involvement included the possibility of gaining a better understanding of risk issues, and discussion about risk enhancing the individual’s ability to maintain their own well-being and safety. Most participants expressed a willingness to be involved in shared decision-making and believed that their friends and family would enable them to be involved. The findings of this study offer valuable insights for targeting behaviour change in future intervention design that seeks to increase shared decision-making in risk assessment and management with individuals with severe mental illness.

Discussions about physical activity in general practice: analysis of video-recorded consultations.

Background Clinical guidance recommends promotion of physical activity during general practice consultations. The frequency and content of physical activity discussions in UK general practice are poorly understood. Aim To explore the content of physical activity discussions during routine consultations between patients and general practitioners (GPs). Design and setting Secondary analysis of video-recorded UK general practice consultations from the One in a Million study. Methods We screened 294 consultation transcripts, identifying consultations that included or omitted physical activity advice when recommended by National Institute for Health and Care Excellence (NICE) guidance. We coded the content, quality and depth of advice provided by GPs. Results Physical activity was relevant to management according to clinical guidance in 175/294 (59.5%) consultations. In 64/175 (36.6%) of these consultations physical activity was discussed as part of clinical management and the depth of discussion was judged as 'meaningful' in 22 (12.6%). Whilst physical activity advice tended to be given most often for musculoskeletal problems, depth of advice did not appear to be related to the presenting problem. When physical activity advice was relevant and omitted, consultations prioritised another overriding presenting problem, or clinical management focussed on another intervention. Conclusion Physical activity advice, following national guidance, was potentially relevant to over half of GP consultations; GPs were able to deliver advice of varying depth in a third of these consultations. Future work should explore ways of delivering physical activity advice effectively, efficiently and equitably within the constraints of general practice. Keywords Physical activity; general practice; video recording.

Continuous Glucose Monitoring Metrics for Pregnancies Complicated by Diabetes: Critical Appraisal of Current Evidence.

Ascertaining the utility of continuous glucose monitoring (CGM) in pregnancy complicated by diabetes is a rapidly evolving area, as the prevalence of type 1 diabetes (T1D), type 2 diabetes (T2D), and gestational diabetes mellitus (GDM) escalates. The seminal randomized controlled trial (RCT) evaluating CGM use added to standard care in pregnancy in T1D demonstrated significant improvements in maternal glycemia and neonatal health outcomes. Current clinical guidance recommends targets for percentage time in range (TIR), time above range (TAR), and time below range (TBR) during pregnancy complicated by T1D that are widely used in clinical practice. However, the superiority of CGM over blood glucose monitoring (BGM) is still questioned in both T2D and GDM, and whether glucose targets should be different than in T1D is unknown. Questions requiring additional research include which CGM metrics are superior in predicting clinical outcomes, how should pregnancy-specific CGM targets be defined, whether CGM targets should differ according to gestational age, and if CGM metrics during pregnancy should be similar across all types of diabetes. Limiting the potential for CGM to improve pregnancy outcomes may be our inability to maintain TIR > 70% throughout gestation, a goal achieved in the minority of patients studied. Adverse pregnancy outcomes remain high in women with T1D and T2D in pregnancy despite CGM technology, and this review explores the potential reasons and questions yet to be investigated.

Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy (STAMINA): study protocol for a randomised controlled trial of the clinical and cost-effectiveness of the STAMINA lifestyle intervention compared with optimised usual care, including internal pilot and parallel process evaluation

BackgroundUK national clinical guidance recommends that men with prostate cancer on androgen deprivation therapy are offered twice weekly supervised aerobic and resistance exercise to address iatrogenic harm caused by treatment. Very few NHS trusts have established adequate provision of such services. Furthermore, interventions fail to demonstrate sustained behaviour change. The STAMINA lifestyle intervention offers a system-level change to clinical care delivery addressing barriers to long-term behaviour change and implementation of new prostate cancer care pathways. This trial aims to establish whether STAMINA is clinically and cost-effective in improving cancer-specific quality of life and/or reducing fatigue compared to optimised usual care. The process evaluation aims to inform the interpretation of results and, if the intervention is shown to benefit patients, to inform the implementation of the intervention into the NHS.MethodsMen with prostate cancer on androgen deprivation therapy (n = 697) will be identified from a minimum of 12 UK NHS trusts to participate in a multi-centre, two-arm, individually randomised controlled trial. Consenting men will have a ‘safety to exercise’ check and be randomly allocated (5:4) to the STAMINA lifestyle intervention (n = 384) or optimised usual care (n = 313). Outcomes will be collected at baseline, 3-, 6- and 12-month post-randomisation. The two primary outcomes are cancer-specific quality of life and fatigue. The parallel process evaluation will follow a mixed-methods approach to explore recruitment and aspects of the intervention including, reach, fidelity, acceptability, and implementation. An economic evaluation will estimate the cost-effectiveness of the STAMINA lifestyle intervention versus optimised usual care and a discrete choice experiment will explore patient preferences.DiscussionThe STAMINA lifestyle intervention has the potential to improve quality of life and reduce fatigue in men on androgen deprivation therapy for prostate cancer. Embedding supervised exercise into prostate cancer care may also support long-term positive behaviour change and reduce adverse events caused by treatment. Findings will inform future clinical care and could provide a blueprint for the integration of supervised exercise and behavioural support into other cancer and/or clinical services.Trial registrationISRCTN 46385239, registered on 30/07/2020. Cancer Research UK 17002, retrospectively registered on 24/08/2022.

Venous thromboembolism prophylaxis and multiple myeloma patients in real-life: Results of a large survey and clinical guidance recommendations from the IFM group

Venous thromboembolism (VTE) remains a critical issue in the management of patients with multiple myeloma (MM), particularly when immunomodulatory drugs (IMiDs) combined with dexamethasone therapy are being prescribed as first-line and relapse therapy. One possible explanation for the persistent high rates of VTE, is the use of inappropriate thromboprophylaxis strategies for patients starting antimyeloma treatment. To tackle the issue, the Intergroupe francophone du myélome (IFM) offered convenient guidance for VTE thromboprophylaxis in MM patients initiating systemic therapy. This guidance is mainly supported by the results of a large survey on the clinical habits regarding VTE of physicians who are substantially involved in daily care of MM patients. VTE prophylaxis should be considered for all patients treated with IMiDs in combination with dexamethasone, in the absence of significant comorbidities, such as renal failure or bleeding risk. Anticoagulant should be preferred to antiplatelet agents for thromboprophylaxis. Despite the absence of large randomized controlled trials comparing those attitudes/options, available data on direct oral anticoagulants, which are already used in daily management of MM patients, are consistent with their potential usefulness for VTE prophylaxis in such patients. However, in order to implement a personalized continuous improvement strategy, clinicians must to be organized to collect all the data regarding this management. In other situations, thromboprophylaxis should be evaluated by using risk models and after careful evaluation of the risk/benefit ratio.

The amniotic fluid index and oligohydramnios: a deeper dive into the shallow end

Second- and third-trimester obstetrical ultrasound examinations include an amniotic fluid volume assessment. Professional organizations' clinical guidance recommends using semiquantitative techniques, such as the single deepest vertical pocket or amniotic fluid index, for this purpose. The single deepest vertical pocket is described as the preferred method of assessing amniotic fluid volume based on fewer oligohydramnios diagnoses and labor inductions with no demonstrable difference in pregnancy outcomes compared with the amniotic fluid index. We offer an alternative interpretation of the evidence for this advice, drawn from 6 randomized clinical trials and 2 meta-analyses comparing the single deepest vertical pocket to the amniotic fluid index. Individually and collectively, these reports are underpowered to detect significant differences in maternal and perinatal outcomes by study group. Moreover, randomized clinical trials comparing maternal and perinatal outcomes resulting from a policy of labor induction at or beyond 37 weeks of gestation vs expectant care consistently favor labor induction, the very intervention paradoxically cited as favoring the single deepest vertical pocket vs the amniotic fluid index. We conclude that the amniotic fluid index should be considered a reasonable method for third-trimester amniotic fluid assessment and diagnosing oligohydramnios.

Cost and Value in Contemporary Heart Failure Clinical Guidance Documents

ObjectivesThis study sought to evaluate the frequency and nature of cost/value statements in contemporary heart failure (HF) clinical guidance documents (CGDs). BackgroundIn an era of rising health care costs and expanding therapeutic options, there is an increasing need for formal consideration of cost and value in the development of HF CGDs. MethodsHF CGDs published by major professional cardiovascular organizations between January 2010 and February 2021 were reviewed for the inclusion of cost/value statements. ResultsOverall, 33 documents were identified, including 5 (15%) appropriate use criteria, 7 (21%) clinical practice guidelines, and 21 (64%) expert consensus documents. Most CGDs (27 of 33; 82%) included at least 1 cost/value statement, and 20 (61%) CGDs included at least 1 cost/value-related citation. Most of these statements were found in expert consensus documents (77.7%). Three (9%) documents reported estimated costs of recommended interventions, but only 1 estimated out-of-pocket cost. Of 179 cost/value-related statements observed, 116 (64.8%) highlighted the economic impact of HF or HF-related care, 6 (3.4%) advocated for cost/value issues, 15 (8.4%) reported gaps in cost/value evidence, and 42 (23.5%) supported clinical guidance recommendations. Over time, patterns of inclusion of statements and citations of cost/value have been largely stable. ConclusionsAlthough most contemporary HF CGDs contain at least 1 cost/value statement, most CGDs focus on the high economic impact of HF and its related care; explicit inclusion of cost/value to support clinical guidance recommendations remains infrequent. These results highlight key opportunities for the integration of formalized cost/value considerations in future HF-focused CGDs.

Diagnostic challenges in lentigo maligna and lentigo maligna melanoma – the Western Sussex maxillofacial experience

Introduction: Diagnostic and management pathways for lentigo maligna (LM) are challenging, due to the risk of transformation into lentigo malignant melanoma (LMM) of 5–20%. Clinical guidance recommends excisional biopsies of 2–5 mm margins as gold standard. Consistency to this between different clinicians and specialties remains poor. We report our experience.

Challenges of treatment adherence with direct oral anticoagulants in pandemic.

Direct oral anticoagulants (DOAC) are crucial for the prevention of thromboembolic events in patients with nonvalvular atrial fibrillation. Drug adherence by the patient but also adherence to guidelines by the physician are suboptimal. This review highlights aspects of DOAC treatment during the coronavirus disease 2019 (COVID-19) pandemic and selected challenging scenarios. For patients with a newly diagnosed indication for oral anticoagulation, a new interim clinical guidance recommends starting DOAC instead of vitamin K antagonists if DOAC are not contraindicated. The goal is to reduce the potential exposure of patients to severe acute respiratory syndrome coronavirus during the routine coagulation monitoring visits. As COVID-19 can lead to kidney failure, we discuss the challenges of DOAC dosing in kidney failures. Finally, we discuss two common challenges - when to start a DOAC after an ischemic stroke linked to atrial fibrillation, and whether cerebral microbleeds, including their count, are per se a contraindication to DOAC. There are still open challenges regarding DOAC treatment on the patient and physician side, both related and unrelated to the pandemic.

ESC/EAS clinical guidance recommendations: impact on patient eligibility for PCSK9 inhibitor therapy

Background: The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been demonstrated to significantly reduce the risk of recurrent adverse vascular events in high-risk patients with a history of coronary, cerebral, or peripheral artery disease. The primary barrier to the use of these drugs is their cost. Use of these drugs in the highest-risk patients would improve their cost-effectiveness. A clinical guidance for the use of these drugs based on vascular risk was recently published.Objectives: To determine how clinical guidance recommendations would impact the numbers of patients eligible to receive PCSK9 inhibitor therapy.Methods: 2000 consecutive patients admitted to an academic medical center referred to a cardiology consult service with documented atherosclerotic cardiovascular disease (ASCVD) were evaluated for PCSK9 inhibitor eligibility using the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) clinical guidance recommendations. Any patient with ASCVD with an LDL-C >140 mg/dl was considered eligible for PCSK9 inhibitor therapy. Patients with an LDL-C >100 mg/dl had to meet additional criteria to be eligible. These criteria included (1) diabetes with target organ damage or another risk factor; (2) severe or extensive CAD; or (3) progressive/accelerated ASCVD, ischemic stroke, or revascularization in the coronary, cerebral, or peripheral arterial system within 2 years of a previous ASCVD event.Results: Mean age was 64.9 ± 12.7 years; 66% were men and 34% were women; 80% were white, 9% were black, 10% were Latino and 1% other. Eligibility for PCSK9 inhibitor therapy included 163 patients with LDL-C >140 mg/dl and 892 patients with LDL-C >100 mg/dl with additional risk factors. Additional risk factors were diabetes plus comorbidity in 318 patients; severe or extensive CAD in 317 patients; and progressive/accelerated ASCVD in 257 patients. The total number of patients eligible for PCSK9 inhibitor therapy using the ESC/EAS criteria was 1055 (53%).Conclusions: Previous studies have estimated 15 to 25% of patients with a history of vascular disease to be eligible for PCSK9 inhibitors. In this high-risk cardiac population, over 50% of patients would be PCSK9 inhibitor eligible. The cost to treat this proportion of patients would represent an overwhelming burden to any health system using current drug costs. Medication access coordinators need to play a critical role in the selection and evaluation of patients eligible for PCSK9 inhibitor therapy to maximize cost-efficiency of this therapy.

Non-pharmacological interventions for non-respiratory sleep disturbance in children with neurodisabilities: a systematic review.

To describe existing evidence on non-pharmacological interventions to manage sleep disturbance in children with neurodisabilities. We systematically reviewed non-pharmacological interventions aimed at improving non-respiratory sleep disturbance in children with neurodisability. Sixteen databases, grey literature, and reference lists of included papers were searched up to February 2017. Two researchers (B.B., C.M., G.S., A.S., A.P.) undertook screening, data extraction, and quality appraisal. Twenty-five studies were included: 11 randomized controlled trials and 14 before-and-after studies. All studies were at high or unclear risk of bias. Parent-directed interventions were categorized as comprehensive tailored interventions (n=9), comprehensive non-tailored interventions (n=8), and non-comprehensive interventions (n=2). Six 'other' non-pharmacological interventions were included. Seventy-one child and parent sleep-related outcomes were measured across the included studies. We report the two most commonly measured outcomes: the Child Sleep Habits Questionnaire and sleep onset latency. Five studies reported significant improvements on at least one of these outcomes. Various types of non-pharmacological intervention for managing sleep disturbance have been evaluated. Clinical heterogeneity and poor study quality meant we could not draw definitive conclusions on the effectiveness of these interventions. Current clinical guidance recommends parent-directed interventions as the first approach to managing sleep disturbance; prioritizing research in this area is recommended. Existing evidence on non-pharmacological interventions to manage sleep disturbance in children with neurodisabilities is predominately of poor quality. Most included studies evaluated parent-directed interventions of varying content and intensity. There was very little consistency between studies in the outcome measures used. There is some evidence that parent-directed interventions may improve child outcomes.

Advancing services for adult ADHD: the development of the ADHD Star as a framework for multidisciplinary interventions.

BackgroundAttention Deficit Hyperactivity Disorder is prevalent in adulthood, resulting in serious impairment across multiple domains of living. Despite clinical guidance recommendations, the relative infancy of research on service provision for adults with ADHD, along with the evidence transfer gap, means that there is a lack of specific frameworks for service delivery. Igniting research and developing service delivery frameworks within adult ADHD is an essential step in the provision of effective services for adults with ADHD.MethodFollowing the methodology used in previous related research that utilises a Participatory Action Research approach, we gathered data from clinicians and service users on the domains of living in which they wish to create change, and the steps and end point of the change process. This data was utilised, alongside data gathered from previous research and policies, to develop the domains of assessment for the ADHD Star, and the scale on which change is assessed.ResultsThe resulting tool, the ADHD Star, consists of eight domains: understanding your ADHD, focus and attention, organising yourself, friends and social life, thinking and reacting, physical health, how you feel and meaningful use of time. Each domain is rated on a five-point scale, the ‘ladder of change’, ranging from ‘stuck’ to ‘choice’.ConclusionsThe ADHD Star offers a guiding framework for the development of care pathways and subsequent service provision for adults with ADHD, based on multi-disciplinary, holistic and person-centred care.

INVESTIGATING PATIENTS EXPERIENCES OF HYPOGLYCAEMIC EMERGENCIES

BackgroundIn Scotland approximately 70% of patients with diabetes treated for a hypoglycaemic event by ambulance clinicians remain at home after treatment. However, many of these individuals experience repeat or subsequent...

Patients' views of physical activity as treatment for depression: a qualitative study

Clinical guidance recommends physical activity to manage patients with persistent subthreshold depressive symptoms or mild-to-moderate depression. However, little is known regarding the acceptability of physical activity as a treatment for depression from patients' perspective. To explore patients' views of physical activity for the treatment of depression in the context of primary care. In-depth interviews were held with 33 participants taking part in a randomised controlled trial assessing the effectiveness of physical activity for the management of depression. Primary care. Most participants perceived physical activity to be an acceptable treatment for depression. The mechanisms by which physical activity could enhance mood were attributed to a number of subjective benefits including biochemical pathways, providing a source of distraction from negative thoughts, and a sense of purpose. Participants who expressed a belief that their depression was caused by biochemical mechanisms reported activity that 'raised the heartbeat' as most beneficial, while those who believed depression was situational in origin tended to state the benefits of less-aerobic activities, such as walking. Many participants reported low motivation and a lack of confidence as barriers to undertaking physical activity. These patients suggested that medication could be helpful for initiating and maintaining activity. Patients view physical activity as an effective treatment for depression. However, they vary in their views about how physical activity might impact on depression, what intensity and form of activity is necessary to enhance mood, and the barriers to undertaking activity. This variation suggests the need for GPs to elicit patients' views on physical activity as a treatment, and offer interventions that are tailored to the needs and expectations of individual patients.