Search

A pilot study of cognitive analytic therapy (CAT) plus treatment as usual (TAU), versus TAU in stressed pregnant women with anxiety and depression, was undertaken as an essential preliminary to any definitive, randomized controlled trial (RCT). The trial was pragmatic, multicentre, parallel, randomized, controlled, and unblinded. Participants were pregnant women screened using the Hospital Anxiety and Depression Scale (HADS). Treatment was standard 16‐session CAT. Main outcome measures were Spielberger State/Trait Anxiety Inventory (STAI) (primary outcome measure) at 24 weeks after randomization, therefore 1 month after therapy for the CAT group; HADS; Clinical Outcomes in Routine Evaluation—Outcome Measure (CORE‐OM); Edinburgh Postnatal Depression Scale (EPDS); 36‐item Short Form Health Survey (SF‐36); and a brief Experiences of Therapy Questionnaire, completed at baseline and on average at 12, 24, 40, and 82 weeks after randomization. Thirty‐nine patients (CAT + TAU, n = 20; TAU, n = 19) were randomized with mean baseline STAI State scores of 50.8 (SD 11.4) and 51.1 (SD 13.3), respectively. Sixteen patients had missing primary outcome data leaving 23 (n = 11 and n = 12) patients for analysis. The mean STAI State score was 38.5 (SD 13.8) and 45.7 (SD 16.8) in the CAT and TAU groups respectively at 24 weeks after randomization, with an adjusted difference in means of 7.2 (95% confidence interval [CI]: −7.9 to 20.6). No safety issues were reported. Patient retention for the CAT group was high (18/20; 90% of patients completed therapy). Ten out of 11 (90.9%) respondents 'agreed' or 'strongly agreed' that having CAT had been 'very helpful'. The study demonstrated the feasibility of safely undertaking CAT in this setting. Outcomes showed positive trends compatible with a clinically important effect, although statistically definitive conclusions cannot be drawn in such a study. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the clinical effectiveness of a self-managed single exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy. Design: Multi-centre pragmatic unblinded parallel group randomised controlled trial. Setting: UK National Health Service. Participants: Patients with a clinical diagnosis of rotator cuff tendinopathy. Interventions: The intervention was a programme of self-managed exercise prescribed by a physiotherapist in relation to the most symptomatic shoulder movement. The control group received usual physiotherapy treatment. Main outcome measures: The primary outcome measure was the Shoulder Pain & Disability Index (SPADI) at three months. Secondary outcomes included the SPADI at six and twelve months. Results: A total of 86 patients (self-managed loaded exercise n=42; usual physiotherapy n=44) were randomised. Twenty-six patients were excluded from the analysis because of lack of primary outcome data at the 3 months follow-up, leaving 60 (n=27; n=33) patients for intention to treat analysis. For the primary outcome, the mean SPADI score at three months was 32.4 (SD 20.2) for the self-managed group, and 30.7 (SD 19.7) for the usual physiotherapy treatment group; mean difference adjusted for baseline score: 3.2 (95% Confidence interval -6.0 to +12.4 P = 0.49). By six and twelve months there remained no significant difference between the groups. Conclusions: This study does not provide sufficient evidence of superiority of one intervention over the other in the short-, mid- or long-term and hence a self-management programme based around a single exercise appears comparable to usual physiotherapy treatment. [ABSTRACT FROM AUTHOR]

Background Sheffield Profile for Assessment and Referral for Care ( SPARC) was developed in response to concerns that palliative care may not be reaching all people who could benefit from it. Acceptability of the tool is an important step in developing its future use. Aims To elicit the views of a wide variety of members of consumer and self-help support groups concerned with health care on the relevance, acceptability and the overall perception of using SPARC as an early holistic needs assessment tool in supportive and palliative care. Methods This study was conducted in South Yorkshire and North Derbyshire (UK). Ninety-nine consumer and self-help groups were identified from information in the public domain. Thirty-eight groups participated. Packs containing study information and self-complete postal questionnaires were distributed to groups, and they were asked to circulate these to their members. Completed questionnaires were returned in pre-paid envelopes to the research team. Results 135 questionnaires and feedback forms were returned. The majority of respondents found SPARC easy to understand (93% (120/129; 95% Confidence Interval 87% to 96%) and complete (94% (125/133; 95% CI: 88% to 97%). A minority, 12.2% (16/131), of respondents found questions on SPARC 'too sensitive'. Conclusions Overall, respondents considered SPARC an acceptable and relevant tool for clinical assessment of supportive and palliative-care needs. Whilst a small minority of people found SPARC difficult to understand (i.e. patients with cognitive impairments), most categories of service user found it relevant. Clinical studies are necessary to establish the clinical utility of SPARC. [ABSTRACT FROM AUTHOR]

Background: The diagnosis of motor neurone disease (MND) has a profound effect on the functioning and well-being of both the patient and their family, with studies describing an increase in carer burden and depression as the disease progresses. Aim: This study aimed to assess whether patient use of noninvasive ventilation (NIV) impacted on their family carer, and to explore other sources of carer burden. Design: The study used qualitative interviews and scaled measures of carer health and well-being completed at three monthly intervals until patient end of life. Participants: Sixteen family carers were followed up over a period ranging from one month to two years. Results: NIV was perceived as having little impact on carer burden. The data however highlighted a range of sources of other burdens relating to the physical strain of caring. The Medical Outcomes Study Short Form (SF-36 Health Survey) Physical Component Summary (PCS) scores were considerably below that of the Mental Component Summary (MCS) score at baseline and at all following time points. Carers described the physical effort associated with patient care and role change; the challenge inherent in having time away; and problems relating to the timing of equipment and service delivery. Conclusions: NIV can be recommended to patients without concerns regarding increasing carer burden. The predominant source of burden described related to the physical impact of caring for a patient with MND. Services face challenges if this physical burden is to be reduced by providing equipment at an optimal time and successfully coordinating their input. [ABSTRACT FROM AUTHOR]

Purpose To investigate the epidemiology and clinicopathological management for ocular sebaceous carcinoma (OSC) in the UK. Methods Observational prospective cohort study of patients with newly-diagnosed OSC. The British Ophthalmological Surveillance Unit captured incident cases of OSC between 2008 and 2010. Incident and 6-month follow-up questionnaires from reporting ophthalmologists captured OSC demographic and clinical data. Results Data were available on 51 patients with unilateral OSC (response rate 85%). The UK estimated annual incidence was 0.41 cases per million population (95% CI 0.31 to 0.54). Median age was 70 years (SD 14, range 28-98) with 57% women. OSC location was upper lid (54%), lower lid (20%), multicentric (14%) and caruncle (12%). Most common misdiagnoses included chalazion (42%), basal cell carcinoma (30%) and blepharoconjunctivitis (16%), with median delay in diagnosis of 10 months (SD 9, range 0.5-36). Specialist ophthalmic pathologists performed diagnostics in 62%, with pagetoid/intraepithelial spread present in 39%. Misdiagnosis of chalazion (p=0.019) and pagetoid tumour spread ( p=0.016) was associated with a significant diagnostic delay (one-way ANOVA/R2). Primary surgical management involved excision with reconstruction (49%), primary exenteration (10%) and Mohs surgery (8%). There were three deaths (out of 51) during the study period; one patient died of OSC-related disease and the other two due to other causes. Conclusions This population-based prospective study confirms OSC as a rare cancer in the UK. Masquerade syndromes result in significant diagnostic delays and increase the risk of pagetoid tumour spread. There is considerable UK variation in pathological and surgical management, and ocular reconstruction and radical surgery is often required for OSC due to delayed presentation. [ABSTRACT FROM AUTHOR]

Introduction: The effect on quality of life by healing leg ulcers is not known and no validated disease-specific tool is available for measuring health-related quality of life (HRQoL) for people with venous leg ulcers. The objective of this paper was to compare four generic instruments [MOS 36-Item Short-Form Health Survey (SF-36); EuroQol (EQ); McGill Short Form Pain Questionnaire (SF-MPQ) and the Frenchay Activities Index (FAI)] used for measuring HRQoL in people with venous leg ulcers, and to offer guidance on the most appropriate tool for researchers.Methods: Two hundred and thirty-three patients with venous leg ulcers were recruited as part of a randomised controlled trial of the cost-effectiveness of community leg ulcer clinics. Subjects completed questionnaires containing the four instruments on three occasions (initial assessment, 3 and 12 months). The discriminative and evaluative properties of the four instruments were compared.Results: All four instruments were acceptable to patients, taking a mean of 19.3 (SD 6.3) min to complete. At initial assessment, the SF-MPQ had poorer discriminative properties than the other three instruments and was not able to distinguish between the different patient groups in relation to age and ulcer duration. The FAI was good at discriminating between the different patient groups (at initial assessment) in relation to age, mobility and ulcer size. At the three-month follow-up, the SF-MPQ was more responsive than the other measures and detected changes in HRQoL, whereas the EQ and SF-36 did not. At 12 months, the SF-MPQ still identified differences and the SF-36 and EQ also did at this stage.Conclusion: In the absence of a validated condition-specific tool for measuring changes in general health status for patients with venous leg ulcers, we make the following recommendations. For evaluating the outcome of interventions with a short-term follow-up (three months) in a clinical study we recommend the SF-MPQ and for 12-month follow-up in a clinical study the SF-36, with or without the SF-MPQ. [ABSTRACT FROM AUTHOR]

Background: Healthy, active ageing is strongly associated with good mental wellbeing which in turn helps to prevent mental illness. However, more investment has been made into research into interventions to prevent mental illness than into those designed to improve mental wellbeing. This applied research programme will provide high quality evidence for an intervention designed to improve and sustain mental wellbeing in older adults.Methods/design: This study was a multi-centre, pragmatic, two-arm, parallel group, individually randomised controlled trial to determine the population benefit of an occupational therapy based intervention for community living people aged 65 years or older. Participants (n = 268) will be identified in one city in the North of England and in North Wales through GP mail-outs, signposting by local authority, primary care staff and voluntary sector organisations and through community engagement. Participants will be randomised to one of two treatment arms: an intervention (Lifestyle Matters programme); or control (routine access to health and social care). All participants will be assessed at baseline, 6 and 24 months post-randomisation. The primary outcome, which is a person reported outcome, is the SF-36 Mental Health dimension at six months post randomisation. Secondary outcome measures have been selected to measure psychosocial, physical and mental health outcomes. They include other dimensions of the SF36, EQ-5D-3L, Brief Resilience Scale, General Perceived Self Efficacy Scale, PHQ-9, de Jong Gierveld Loneliness Scale, Health and Social Care Resource Use and the wellbeing question of the Integrated Household Survey 2011. A cost effectiveness analysis will investigate the incremental cost per Quality Adjusted Life Years (QALYs) of the Lifestyle Matters intervention compared with treatment as usual.Discussion: The questions being posed through this research are important given the increasing numbers of older people, pressure on the public purse and the associated need to support good health in the extended lifespan. The proposed trial will determine the clinical and cost effectiveness of the intervention delivered in a UK context. The results will support commissioners and providers with decisions about implementation.Trial Registration: Current Controlled Trials ISRCTN67209155. [ABSTRACT FROM AUTHOR]

Older patients with early breast cancer (EBC) derive modest survival benefit from chemotherapy but have increased toxicity risk. Data on the impact of chemotherapy for EBC on quality of life in older patients are limited, but this is a key determinant of treatment acceptance. We aimed to investigate its effect on quality of life in older patients enrolled in the Bridging the Age Gap study. A prospective, multicentre, observational study of EBC patients ≥70 years old was conducted in 2013–2018 at 56 UK hospitals. Demographics, patient, tumour characteristics, treatments and adverse events were recorded. Quality of life was assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires (EORTC-QLQ) C30, BR23 and ELD 15 plus the Euroqol-5D (eq-5d) over 24 months and analysed at each time point using baseline adjusted linear regression analysis and propensity score-matching. Three thousand and four hundred sixteen patients were enrolled in the study; 1520 patients undergoing surgery and who had high-risk EBC were included in this analysis. 376/1520 (24.7%) received chemotherapy. At 6 months, chemotherapy had a significant negative impact in several EORTC-QLQ-C30 domains, including global health score, physical, role, social functioning, cognition, fatigue, nausea/vomiting, dyspnoea, appetite loss, diarrhoea and constipation. Similar trends were documented on other scales (EORTC-QLQ-BR23, EORTC-QLQ-ELD15 and EQ-5D-5L). Its impact was no longer significant at 18–24 months in unmatched and matched cohorts. The negative impact of chemotherapy on quality-of-life is clinically and statistically significant at 6 months but resolves by 18 months, which is crucial to inform decision-making for older patients contemplating chemotherapy. 46099296. • This is a multicentre, cohort study of 3416 women (aged >70 years) with breast cancer. • In older women with high-risk, early breast cancer, chemotherapy reduces quality of life. • The relevant affected domains include cognition, fatigue, physical, role and social functioning. • Chemotherapy QoL impacts are transient and largely resolve completely by 18–24 months. [ABSTRACT FROM AUTHOR]