UK Clinical Guidance Research Articles

A realist review of health passports for Autistic adults.

Autism is a normal part of cognitive diversity, resulting in communication and sensory processing differences, which can become disabling in a neurotypical world. Autistic people have an increased likelihood of physical and mental co-occurring conditions and die earlier than neurotypical peers. Inaccessible healthcare may contribute to this. Autism Health Passports (AHPs) are paper-based or digital tools which can be used to describe healthcare accessibility needs; they are recommended in UK clinical guidance. However, questions remained as to the theoretical underpinnings and effectiveness of AHPs. We undertook a systematic literature search identifying studies focused on AHPs for adults (aged over 16 years) from five databases. Included literature was subjected to realist evaluation. Data were extracted using a standardised form, developed by the research team, which considered research design, study quality for realist review and the Context, Mechanisms and Outcomes (CMOs) associated with each AHP tool. 162 unique records were identified, and 13 items were included in the review. Only one item was considered high quality. Contextual factors focused on the inaccessibility of healthcare to Autistic patients and staff lack of confidence and training in supporting Autistic needs. Interventions were heterogeneous, with most sources reporting few details as to how they had been developed. The most frequently included contents were communication preferences. Mechanisms were often not stated or were inferred by the reviewers and lacked specificity. Outcomes were included in four studies and were primarily focused on AHP uptake, rather than Outcomes which measured impact. There is insufficient evidence to conclude that AHPs reduce the health inequalities experienced by Autistic people. Using an AHP tool alone in a healthcare Context that does not meet Autistic needs, without the inclusion of the local Autistic community developing the tool, and a wider intervention to reduce known barriers to health inequality, may mean that AHPs do not trigger any Mechanisms, and thus cannot affect Outcomes.

The PLANES study: a protocol for a randomised controlled feasibility study of the placental growth factor (PlGF) blood test-informed care versus standard care alone for women with a small for gestational age fetus at or after 32 + 0\u2009weeks\u2019 gestation

BackgroundStillbirth remains a major concern across the globe and in some high-resource countries, such as the UK; efforts to reduce the rate have achieved only modest reductions. One third of stillborn babies are small for gestational age (SGA), and these pregnancies are also at risk of neonatal adverse outcomes and lifelong health problems, especially when delivered preterm. Current UK clinical guidance advocates regular monitoring and early term delivery of the SGA fetus; however, the most appropriate regimen for surveillance of these babies remains unclear and often leads to increased intervention for a large number of these women. This pilot trial will determine the feasibility of a large-scale trial refining the risk of adverse pregnancy outcome in SGA pregnancies using biomarkers of placental function sFlt-1/PlGF, identifying and intervening in only those deemed at highest risk of stillbirth.MethodsPLANES is a randomised controlled feasibility study of women with an SGA fetus that will be conducted at two tertiary care hospitals in the UK. Once identified on ultrasound, women will be randomised into two groups in a 3:1 ratio in favour of sFlt-1/PlGF ratio led management vs standard care. Women with an SGA fetus and a normal sFlt-1/PlGF ratio will have a repeat ultrasound and sFlt-1/PlGF ratio every 2 weeks with planned birth delayed until 40 weeks. In those women with an SGA fetus and an abnormal sFlt-1/PlGF ratio, we will offer birth from 37 weeks or sooner if there are other concerning features on ultrasound. Women assigned to standard care will have an sFlt-1/PlGF ratio taken, but the results will be concealed from the clinical team, and the woman’s pregnancy will be managed as per the local NHS hospital policy. This integrated mixed method study will also involve a health economic analysis and a perspective work package exploring trial feasibility through interviews and questionnaires with participants, their partners, and clinicians.DiscussionOur aim is to determine feasibility through the assessment of our ability to recruit and retain participants to the study. Results from this pilot study will inform the design of a future large randomised controlled trial that will be adequately powered for adverse pregnancy outcome. Such a study would provide the evidence needed to guide future management of the SGA fetus.Trial registrationISRCTN58254381. Registered on 4 July 2019

Current trends in pessary management of vaginal prolapse: a multidisciplinary survey of UK practice.

Symptomatic vaginal prolapse affects 6-28% of women and significantly impacts their quality of life. Pessaries for prolapse are used by three-quarters of clinicians as a first-line treatment; however, current clinical use in the UK is unknown and there is a lack of clinical guidance or training. This study is aimed at informing the upcoming UK Clinical Guidance on best practice for the use of pessaries document. A 19-question, anonymised, electronic survey was sent to members of the nine professional bodies delivering pessary care in the UK. Of 917 respondents, 403 (246 nurses, 134 doctors, 22 physiotherapists and 1 other profession) currently deliver pessary care. PVC/vinyl ring, silicone ring, Gellhorn and shelf pessaries are most popular, and are used frequently by 93% of respondents. Further pessary training was deemed necessary by 62% of those currently providing pessary care, and 70% of those who do not. The most highly rated method for previous and future training is shadowing another clinician. One in three respondents receive no ancillary support and nearly 1 in 7 (predominantly nurses) report the absence of cross-cover arrangements, leaving a gap in care provision. Service provision, support and pessary training in the UK vary greatly. This calls for the standardisation of care, training and development of a national guideline. We present a clear rationale and need for a UK guideline on pessary management of vaginal prolapse and a standardised pessary training model for multi-professional use.

A service evaluation to determine where and who delivers pessary care in the UK.

Pessaries offer effective conservative management for symptoms of pelvic organ prolapse and are frequently used in the UK. Previous publications have highlighted a lack of evidence-based pessary guidelines. There is also a dearth of evidence regarding who UK pessary practitioners are and the training received. A Freedom of Information request was sent to 167 healthcare organisations in the UK. Requested information included the number of pessaries inserted or changed, the grade and profession of pessary practitioners and training requirements at the organisation. Responses were received from 128 organisations. One hundred and ten had provided information for practitioners managing pessaries. At 66% (72) of organisations, pessary care was provided by both doctors and nurses of varying grades. At 23% of organisations either solely doctors or solely nurses provided pessary care. At the remaining 9% there was a multidisciplinary approach to pessary care. At 3 hospitals, unregistered healthcare professionals provided pessary care. At the majority of organisations, respondents undertook supervised practise to gain skills in pessary management. Additional methods of training cited were learning through observation or achieving set competencies. Twenty-six percent received didactic training. At 21% of organisations there were no training requirements. At most organisations, there was a multidisciplinary approach to pessary care. It is questionable whether unregistered healthcare professionals should be delegated responsibility for pessary care. A standardised approach to pessary practitioner training is advocated to ensure that women receive safe, evidence-based pessary care. The UK Clinical Guidance Group for the Use of Pessaries in Vaginal Prolapse is currently developing national evidence-based guidelines to support pessary practitioners in their practice, including training requirements.

The cost-effectiveness of initiating ranibizumab therapy in eyes with neovascular AMD with good vision: an economic model using real-world outcomes

ObjectivesTo evaluate the cost-effectiveness of immediate treatment with ranibizumab in patients with neovascular age-related macular degeneration (nAMD) with good (better than 6/12) starting visual acuity compared with current UK clinical...

‘My body's falling apart.’ Understanding the experiences of patients with advanced multimorbidity to improve care: serial interviews with patients and carers

ObjectiveMultimorbidity is increasingly common in the last year of life, and associated with frequent hospital admissions. The epidemiology is well described, but patient perspectives are less understood. We report the...

Enabling patients with respiratory symptoms to access chest X-rays on demand: the experience of the walk-in service in Corby, UK

UK clinical guidance for lung cancer (NICE 141) includes pathways for chest X-rays (CXRs). Many patients fulfilling the criteria do not receive one, either because they do not consult their doctor or because their doctor does not refer them. The town of Corby, UK, has particularly high incidence and mortality rates for lung cancer and was chosen as a pilot site for a new, patient-requested X-ray service. The number of community-initiated CXRs were compared before and after the introduction of the service and between similar geographical areas. Clinical data and patient questionnaires were analysed for those attending the service. There was a 63% increase in the total number of community-initiated CXRs in Corby for the year following the introduction of the service, compared with the year before. This was statistically greater than in surrounding geographical areas. Corby General Practitioners also requested 47% more CXRs than in the previous year. The implementation of the service was associated with a significant increase in the numbers of clinically indicated CXRs in an area of high lung cancer incidence and mortality. The service attracted a clinically appropriate population. The numbers of cancers detected were in line with statistical expectations.

Systematic review of supportive care needs in patients with primary malignant brain tumors

In adults, primary malignant brain tumors (PMBT) are rare, but they have a devastating impact and the chances for survival are limited. UK clinical guidance on supportive care for patients with brain and central nervous system tumors was published in 2006 and relied on very limited evidence. The current article reviews literature from 2005 through 2011 on the psychosocial and supportive needs of patients with PMBT and their families or caregivers. Searches were conducted in PubMed, Web of Science, Psychinfo, Cochrane, Scopus, ASSIA, and Sciencedirect. The search initially yielded 6220 articles, of which 60 were found to be eligible (1%). Eleven qualitative and 49 quantitative studies are reviewed here and mapped onto the structure of the existing UK clinical guidance. Studies suggest rates of depression and anxiety up to 48% in patients and up to 40% in caregivers, with many unmet needs and dissatisfaction with health care provider communication and information. Cognitive deficits increase as the disease progresses, hampering communication and decision-making. A range of neurological and physical symptoms at the end of life need recognition. Some successful supportive and neuropsychological interventions are reported. Although the volume of available studies has increased since UK guidance, many remain observational in nature, with few trials of interventions. However, this review provides an up to date resource for clinicians involved with patients with PMBT, describing current knowledge on patients' psychosocial needs, the type of care which has been found to be beneficial, and highlighting areas where more research needs to be done.

Trastuzumab beyond progression in HER2-positive advanced breast cancer: The Royal Marsden experience

Background:Recent UK clinical guidance advises against continuing trastuzumab (T) beyond disease progression (PD) in the absence of brain metastases in patients with HER-2 positive (+ve) advanced breast cancer .We have retrospectively evaluated the outcome of patients with HER-2+ve locally advanced (LA) or metastatic breast cancer (MBC) who continued T beyond PD, treated in our unit.Methods:All HER-2+ve patients on our prospectively maintained database with LA or MBC who received T beyond PD after adjuvant or one line of T for advanced disease were assessed for response and outcome. From the timepoint of T continuation beyond PD, we calculated the overall disease control rate, time to progression (TTP), and overall survival (OS).Results:One hundred and fourteen patients with HER-2+ve LA or MBC treated with T beyond PD were identified. The main site of disease was visceral_in 84 (74%) patients. Seventy-six (66%) had one line of chemotherapy before continuation of T beyond PD and 21 (19%) had two or more. Post-progression, 66 (58%) received T combined with chemotherapy. Of the 93 (82%) patients with documented clinical or radiological response evaluation, 67 (59%) were considered as having stable disease or better. The median TTP was 24 weeks (95% CI: 21–28) and the median OS was 19 months (95% CI: 12–24).Conclusion:Our results from an unselected group of patients provide additional evidence that continuation of T beyond PD is of clinical benefit.

Abstract P6-11-11: Trastuzumab beyond Progression in HER2-Positive Advanced Breast Cancer: The Royal Marsden Experience

Abstract Background: Routine clinical practice and a growing body of evidence support the continuation of trastuzumab (T) in patients with HER-2 positive (+ve) advanced breast cancer progressing on previous T-based therapy. Despite this, recent UK clinical guidance advises against continuing T on evidence of disease progression (PD) in the absence of brain metastases. This retrospective study therefore evaluated the outcome of patients (pts) with HER-2+ve locally advanced (LA) or metastatic breast cancer (MBC) who continued T beyond PD, treated in our Unit. Patients and methods: HER-2+ve pts receiving T for LA or MBC were identified from our prospectively maintained database and pharmacy records. Those receiving T beyond PD after adjuvant or one line of T for advanced disease were assessed for response and outcome. From thetimepoint of T continuation beyond PD we calculated the overall disease control rate (response or stable disease), time to progression (TTP), and overall survival (OS). Results: 114 pts with HER-2+ve LA or MBC treated with T beyond PD were identified. At the time of analysis 35 (31%) pts were still alive with a median follow up of 20 months (mo). The main site of disease was visceral in 84 (74%) pts, including 37 (32%) pts with CNS involvement. 30 (26%) pts had soft tissue or bone metastases only. Fifty nine (52%) pts had received adjuvant chemotherapy and 13 (11%) pts had received adjuvant T. Seventy six (66%) pts had 1 line of chemotherapy prior to continuation of T beyond PD and 21 (19%) had 2 or more lines. Fifty three (46%) pts had previously received taxanes + T for their LA or MBC. Post-progression, 66 (58%) pts received T combined with chemotherapy; 12 (11%) taxane-based, 32 (28%) capecitabine and 22 (19%) vinorelbine. Information regarding response was not available in 21(18%) pts. Of the ninety three (82%) pts with documented clinical (n=16) or radiological (n=77) response evaluation, 68 (60%) pts were considered as having stable disease (SD) or better and 25 (22%) as having PD. The median duration of T was 10 mo (95% CI: 8-11 mo), the median TTP was 24wks (95% CI: 21-28 wks) and the median OS was 19 mo (95% CI:12-24mo). In a sub-group analysis of the 81(71%) pts who received T as first-line Rx or relapsed within 12 wks of adjuvant T, overall disease control was achieved in 50 (61%) pts, the median TTP was 25wks (95% CI:18-33 wks) and the median OS was 22 mo(95% CI:17-27mo). In terms of safety, only 6 (5%) pts overall had to discontinue T secondary to decline in left ventricular ejection fraction. Conclusion: Our results from an unselected group of patients are supported by positive results from other studies and provide additional evidence that continuation of trastuzumab beyond disease progression is of clinical benefit. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P6-11-11.