Wanda Russell

Enhanced low vision rehabilitation for people with age related macular degeneration: A randomised controlled trial

Aim: To compare the effectiveness of three models of low vision rehabilitation for people with age related macular degeneration (AMD) referred for low vision rehabilitation (LVR): (a) an enhanced low vision rehabilitation model (ELVR) including supplementary home based low vision rehabilitation; (b) conventional low vision rehabilitation (CLVR) based in a hospital clinic; (c) CLVR with home visits that did not include rehabilitation (CELVR), intended to act as a control for the additional contact time with ELVR. Method: A single centre parallel group randomised controlled trial in participants’ homes and the low vision clinic, Manchester Royal Eye Hospital. People referred for LVR with a primary diagnosis of AMD and visual acuity worse than 6/18 in both eyes and equal to or better than 1/60 in the better eye. The main outcome measures were vision specific quality of life (QoL) (primary outcome, VCM1) and generic health related QoL (SF-36); psychological adjustment to vision loss; measured task performance; restriction in everyday activities; use of low vision aids (LVAs). Results: 226 participants were recruited (median age 82 years); 194 completed the trial (86%). Except for SF-36 physical and mental component summary scores, arms did not differ significantly for any of the outcomes. Differences for the VCM1 were ELVR v CLVR, 0.06 (95% CI to 0.17 to 0.30, p = 0.60); ELVR v CELVR, 0.12 (95% CI to 0.11 to 0.34, p = 0.31); CELVR v CLVR, –0.05 (95% CI –0.29 to 0.18, p = 0.64). Differences for the SF-36 favoured CLVR compared to ELVR (ELVR v CLVR: physical = –6.05, 95% CI –10.2 to –1.91, p = 0.004; mental = –4.04, 95% CI –7.44 to –0.65, p = 0.02). At 12 months, 94% of participants reported using at least one LVA. Conclusion: ELVR was no more effective than CLVR. Researchers should be wary of proposing new LVR interventions without preliminary evidence of effectiveness, given the manifest lack of effectiveness of the model of enhanced LVR evaluated in the trial.

The effectiveness and cost-effectiveness of acupressure for the control and management of chemotherapy-related acute and delayed nausea: Assessment of Nausea in Chemotherapy Research (ANCHoR), a randomised controlled trial

BACKGROUND Chemotherapy-induced nausea and vomiting remain difficult symptoms to manage in clinical practice. As standard antiemetic drugs do not fully eliminate these symptoms, it is important to explore the adjuvant role of non-pharmacological and complementary therapies in antiemetic management approaches. Acupressure is one such treatment showing highly suggestive evidence so far of a positive effect, meriting further investigation. OBJECTIVES The primary objective was to assess the effectiveness and cost-effectiveness of self-acupressure using wristbands compared with sham acupressure wristbands and standard care alone in the management of chemotherapy-induced nausea. Secondary objectives included assessment of the effectiveness and cost-effectiveness of the wristbands in relation to vomiting and quality of life and exploration of any age, gender and emetogenic risk effects. DESIGN Randomised three-arm sham-controlled trial (Assessment of Nausea in Chemotherapy Research or ANCHoR) with an economic evaluation. Arms include the wristband arm, the sham wristband arm and the standard care only arm. Randomisation consisted of minimisation with a random element balancing for gender, age (16-24, > 24-50, >50 years) and three levels of emetogenic chemotherapy (low, moderate and high). Qualitative interviews were incorporated to shed more light on the quantitative findings. SETTING Outpatient chemotherapy clinics in three regions in the UK involving 14 different cancer units/centres. PARTICIPANTS Chemotherapy-naive cancer patients receiving chemotherapy of low, moderate and high emetogenic risk. INTERVENTION The intervention was acupressure wristbands pressing the P6 point (anterior surface of the forearm). MAIN OUTCOME MEASURES The Rhodes Index for Nausea/Vomiting, the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool and the Functional Assessment of Cancer Therapy - General (FACT-G). At baseline participants completed measures of anxiety/depression, nausea/vomiting expectation and expectations from using the wristbands. RESULTS In total, 500 patients were randomised in the study arms (166 standard care, 166 sham acupressure and 168 acupressure) and data were available for 361 participants for the primary outcome. The primary outcome analysis (nausea in cycle 1) revealed no statistically significant differences between the three arms, although the median nausea experience in patients using wristbands (both real and sham ones) was somewhat lower than that in the antiemetics only group (median nausea experience scores for the four cycles: standard care arm 1.43, 1.71, 1.14, 1.14; sham acupressure arm 0.57, 0.71, 0.71, 0.43; acupressure arm 1.00, 0.93, 0.43, 0). A gender effect was evident (p= 0.002), with women responding more favourably to the use of sham acupressure wristbands than men (odds ratio 0.35 for men and 2.02 for women in the sham acupressure group; 1.27 for men and 1.17 for women in the acupressure group). This suggests a placebo effect. No significant differences were detected in relation to vomiting outcomes, anxiety and quality of life. Some transient adverse effects were reported, including tightness in the area of the wristbands, feeling uncomfortable when wearing them and minor swelling in the wristband area (n= 6).There were no statistically significant cost differences associated with the use of real acupressure bands (£70.66 for the acupressure group, £111.13 for the standard care group and £161.92 for the sham acupressure group). In total, 26 subjects took part in qualitative interviews. The qualitative data suggested that participants perceived the wristbands (both real and sham) as effective and helpful in managing their nausea during chemotherapy. CONCLUSIONS There were no statistically significant differences between the three arms in terms of nausea, vomiting and quality of life, although apparent resource use was less in both the real acupressure arm and the sham acupressure arm compared with standard care only; therefore; no clear conclusions can be drawn about the use of acupressure wristbands in the management of chemotherapy-related nausea and vomiting. However, the study provided encouraging evidence in relation to an improved nausea experience and some indications of possible cost savings to warrant further consideration of acupressure both in practice and in further clinical trials. TRIAL REGISTRATION ISRCTN87604299. SOURCE OF FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 26. See the HTA programme website for further project information.

Randomised controlled trial of an integrated versus an optometric low vision rehabilitation service for patients with age-related macular degeneration: study design and methodology

A number of studies have measured the outcomes of low vision care but these have usually been longitudinal case series, thus constituting very low quality of evidence for effectiveness. To date, there have been no randomised controlled trials (RCTs) which have evaluated the effectiveness and cost effectiveness of different models of care in low vision. The size of the low vision population and the paucity of systematic evaluation have created a pressing need for evidence about cost‐effectiveness in order to inform service developments for low vision rehabilitation. This paper describes the study design and methodology of a three‐arm RCT currently under way in Manchester. The baseline population recruited is also described. A traditional hospital‐based optometric service is being compared with an integrated service (comprising the addition of community‐based rehabilitation officer input) and with more generic community input (which is non‐integrated and is not vision specific). A wide range of outcome measures are being assessed at recruitment and 12 months post‐intervention, including low vision specific and generic quality of life measures, patterns of low vision aid use, and task performance. The rationale for the trial is discussed and the main study outcomes are described.

A dental workforce review for a Midlands Strategic Health Authority.

Objective To explore opportunities for workforce development in NHS general dental services (GDS) in Shropshire and Staffordshire.Method Secondary data sources were supplemented with a primary survey of GDS practices to build up a profile of the existing GDS workforce and its current capacity. Attitudes and perceptions on current workforce issues and potential solutions were gathered using a second survey and explored further through other qualitative techniques including interviews and a focus group discussion.Results The results confirm that there is a shortage of dentists in the area, fuelled by multiple factors including the move from NHS to private work, the decision to retire early and a growing disillusionment with NHS policies and remuneration. Modelling of alternate approaches to future dental clinical needs highlighted the opportunity for meeting the consequent workforce demands through increased involvement of hygienists and therapists.Conclusions This study has provided local evidence to inform dental service development in Shropshire and Staffordshire. It has provided a starting point for exploring new ways of working and will contribute towards a more effective implementation of new and evolving service strategies.

The diagnostic accuracy of the HITSNS prehospital triage rule for identifying patients with significant traumatic brain injury: a cohort study.

Diversion of suspected traumatic brain injury (TBI) patients to trauma centres may improve outcomes by expediting access to specialist neurosurgical care. This study aimed to determine the accuracy of the Head Injury Straight to Neurosurgery (HITSNS) triage rule for identifying patients with significant TBI. A diagnostic cohort study was performed using data from the HITSNS trial, the Trauma Audit and Research Network registry and the North East Ambulance service database. Sensitivity and specificity of the HITSNS triage rule were calculated against a reference standard of significant TBI, defined by a cranial Abbreviated Injury Scale score of at least 3 or by the performance of a neurosurgical procedure. A total of 3628 patients were included in the complete case analyses. The HITSNS triage tool demonstrated a sensitivity of 28.3% (95% confidence interval 21.8–35.4) and a specificity of 94.4% (95% confidence interval 93.6–95.2). The low sensitivity of the HITSNS triage rule suggests that a considerable proportion of patients with significant TBI may not be triaged directly to trauma centres, and further research is needed to improve the accuracy of bypass protocols.

The challenges of conducting prehospital research: successes and lessons learnt from the Head Injury Transportation Straight to Neurosurgery (HITS-NS) trial

Head Injury Transportation Straight to Neurosurgery was a cluster randomised trial studying suspected severe head injury treatment pathways conducted in the North East Ambulance Service NHS Foundation Trust and North West Ambulance Service NHS Trust between January 2012 and March 2013. This was the worlds first large scale trial of any trauma bypass and was conducted as a feasibility study. This short report will describe some of the lessons learnt during this ground breaking and complex trial.

Promoting evidence informed service development: a study of falls services in Cheshire

This study investigated two initiatives for preventing falls in Cheshire: public events to raise population awareness about falls and ways of preventing falls, a programme of falls assessments and falls prevention classes. Aim The study aimed to support service development by generating local learning about: the falls risk status of older people attending the public events and their use of services for preventing falls, the efficiency and effectiveness of the falls programme. Methods A local adaptation of an instrument used in similar research was administered to assess the falls risk status of older people attending the public events. This instrument captures data about the age, sex, gait, sensory deficit, falls history, current medication, medical history, mobility and living situation of respondents. Attendees were also asked about their current use of falls services. To evaluate the falls programme data were collected about the characteristics and referral sources of service users and, for users of the falls prevention classes: their mobility and balance on joining and completing the classes; their fear of falling and confidence linked to falls at the start of the classes and six months later; the number of falls they experienced in the six months before starting and after completing the classes. Findings Of the 453 attendees screened, 64.3% were at medium risk of falling or above and 34.3% had suffered previous falls. None were accessing falls prevention services. During its first year, 324 individuals were referred to the falls programme. Overall, among those individuals who provided data for analysis, there was a statistically significant improvement in the ‘clinical’ outcomes assessed and a statistically significant reduction in the occurrence of falls. The majority of respondents indicated that they achieved an improved confidence linked to falls and a reduced fear of falling. Conclusions Studies of this type can provide a valuable contribution to local learning but the characteristics of the research collaborations developed can affect study designs and the quality of the information generated. Improved contracting arrangements between service commissioners and providers may provide an opportunity to increase the rigour of local developmental studies.

The effects of care bundles on patient outcomes: A systematic review and meta-analysis

BackgroundCare bundles are a set of three to five evidence-informed practices performed collectively and reliably to improve the quality of care. Care bundles are used widely across healthcare settings with the aim of preventing and managing different health conditions. This is the first systematic review designed to determine the effects of care bundles on patient outcomes and the behaviour of healthcare workers in relation to fidelity with care bundles.MethodsThis systematic review is reported in line with the PRISMA statement for reporting systematic reviews and meta-analyses. A total of 5796 abstracts were retrieved through a systematic search for articles published between January 1, 2001, to February 4, 2017, in the Cochrane Central Register for Controlled Trials, MEDLINE, EMBASE, British Nursing Index, CINAHL, PsychInfo, British Library, Conference Proceeding Citation Index, OpenGrey trials (including cluster-randomised trials) and non-randomised studies (comprising controlled before-after studies, interrupted time series, cohort studies) of care bundles for any health condition and any healthcare settings were considered. Following the removal of duplicated studies, two reviewers independently screen 3134 records. Three authors performed data extraction independently. We compared the care bundles with usual care to evaluate the effects of care bundles on the risk of negative patient outcomes. Random-effect models were used to further explore the effects of subgroups.ResultsIn total, 37 studies (6 randomised trials, 31 controlled before-after studies) were eligible for inclusion. The effect of care bundles on patient outcomes is uncertain. For randomised trial data, the pooled relative risk of negative effects between care bundle and control groups was 0.97 [95% CI 0.71 to 1.34; 2049 participants]. The relative risk of negative patient outcomes from controlled before-after studies favoured the care bundle treated groups (0.66 [95% CI 0.59 to 0.75; 119,178 participants]). However, using GRADE, we assessed the certainty of all of the evidence to be very low (downgraded for risk of bias, inconsistency, indirectness).ConclusionsVery low quality evidence from controlled before-after studies suggests that care bundles may reduce the risk of negative outcomes when compared with usual care. By contrast, the better quality evidence from six randomised trials is more uncertain.Trial registrationPROSPERO, CRD42016033175

Bypassing nearest hospital for more distant neuroscience care in head-injured adults with suspected traumatic brain injury: findings of the head injury transportation straight to neurosurgery (HITS-NS) pilot cluster randomised trial

Objective Reconfiguration of trauma services, with direct transport of patients with traumatic brain injury (TBI) to specialist neuroscience centres (SNCs)—bypassing non-specialist acute hospitals (NSAHs), could improve outcomes. However, delays in stabilisation of airway, breathing and circulation (ABC) may worsen outcomes when compared with selective secondary transfer from nearest NSAH to SNC. We conducted a pilot cluster randomised controlled trial to determine the feasibility and plausibility of bypassing suspected patients with TBI —directly into SNCs—producing a measurable effect. Setting Two English Ambulance Services. Participants 74 clusters (ambulance stations) were randomised within pairs after matching for important characteristics. Clusters enrolled head-injured adults—injured nearest to an NSAH—with internationally accepted TBI risk factors and stable ABC. We excluded participants attended by Helicopter Emergency Medical Services or who were injured more than 1 hour by road from nearest SNC. Interventions Intervention cluster participants were transported directly to an SNC bypassing nearest NSAH; control cluster participants were transported to nearest NSAH with selective secondary transfer to SNC. Outcomes Trial recruitment rate (target n=700 per annum) and percentage with TBI on CT scan (target 80%) were the primary feasibility outcomes. 30-day mortality, 6-month Extended Glasgow Outcome Scale and quality of life were secondary outcomes. Results 56 ambulance station clusters recruited 293 patients in 12 months. The trial arms were similar in terms of age, conscious level and injury severity. Less than 25% of recruited patients had TBI on CT (n=70) with 7% (n=20) requiring neurosurgery. Complete case analysis showed similar 30-day mortality in the two trial arms (control=8.8 (2.7–14.0)% vs intervention=9.4(2.3–14.0)%). Conclusion Bypassing patients with suspected TBI to SNCs gives an overtriage (false positive) ratio of 13:1 for neurosurgical intervention and 4:1 for TBI. A measurable effect from a full trial of early neuroscience care following bypass is therefore unlikely. Trial registration number ISRCTN68087745.

OA01.04. The effectiveness and cost effectiveness of acupressure for chemotherapy-related nausea

Methods Randomised three-group sham-controlled trial. Patients with heterogeneous cancer diagnoses receiving low, moderate and highly emetogenic chemotherapy randomised to receive, in addition to standardised antiemetics, either acupressure wristbands, sham acupressure wristbands or antiemetics alone. Patients were instructed to wear the wristbands for 7 days during each cycle of chemotherapy. Patients participated for 4 cycles of chemotherapy. An economic evaluation was carried out based on drug and health service utilisation. A nested qualitative interview study was also incorporated to shed more light into quantitative findings.