Different frequencies of acupuncture for treatment for chronic low back pain: an-assessor blinded pilot randomised controlled trial.

OBJECTIVES:
To examine the feasibility of a main RCT to compare the effectiveness of two frequencies (2 versus 5 times/week) of acupuncture treatment for chronic low back pain (LBP).
METHODS:
Participants (n=30) with chronic LBP were randomised into two groups to receive 10 acupuncture treatments: Low Frequency Group, 2 times/week for five weeks (n=15); High Frequency Group, 5 times/week for two weeks (n=15). The following outcomes were measured blindly at baseline, 2 weeks, 5 weeks, 3 months and 1 year: pain on a VAS, functional disability using the RMDQ, quality of life using the Measure Yourself Medical Outcome Profile (MYMOP-2), psychological impact with the Coping Strategies Questionnaire (CSQ) and Pain Locus of Control (PLC) questionnaire. Two objective outcomes, the Shuttle Walk Test (SWT) and Lateral Trunk Flexibility (LTF), were also measured.
RESULTS:
The compliance rate was 100% for each group. Some of the measurements were shown to be sensitive (VAS, RMDQ, MYMOP-2 Wellbeing). 66-330 participants would be required for a fully powered non-inferiority trial. The groups were balanced at baseline for LBP and demographic characteristics. There were no significant differences between the groups in terms of any of the outcomes, at each follow-up time point. It was notable however that the clinically important improvement in terms of pain, functional disability, quality of life, and SWT in both groups was achieved within the first two weeks, which was maintained at one year follow-up.
CONCLUSIONS:
It is feasible to conduct a main RCT, to compare different frequencies of acupuncture for LBP, using sensitive measurements. Also the trend for early clinically important improvement within a minimum of four measurements is worthy of further study.

Latanoprost for open-angle glaucoma (UKGTS): a randomised, multicentre, placebo-controlled trial

Background
Treatments for open-angle glaucoma aim to prevent vision loss through lowering of intraocular pressure, but to our knowledge no placebo-controlled trials have assessed visual function preservation, and the observation periods of previous (unmasked) trials have typically been at least 5 years. We assessed vision preservation in patients given latanoprost compared with those given placebo.

Methods
In this randomised, triple-masked, placebo-controlled trial, we enrolled patients with newly diagnosed open-angle glaucoma at ten UK centres (tertiary referral centres, teaching hospitals, and district general hospitals). Eligible patients were randomly allocated (1:1) with a website-generated randomisation schedule, stratified by centre and with a permuted block design, to receive either latanoprost 0·005% (intervention group) or placebo (control group) eye drops. Drops were administered from identical bottles, once a day, to both eyes. The primary outcome was time to visual field deterioration within 24 months. Analyses were done in all individuals with follow-up data. The Data and Safety Monitoring Committee (DSMC) recommended stopping the trial on Jan 6, 2011 (last patient visit July, 2011), after an interim analysis, and suggested a change in primary outcome from the difference in proportions of patients with incident progression between groups to time to visual field deterioration within 24 months. This trial is registered, number ISRCTN96423140.

Findings
We enrolled 516 individuals between Dec 1, 2006, and March 16, 2010. Baseline mean intraocular pressure was 19·6 mm Hg (SD 4·6) in 258 patients in the latanoprost group and 20·1 mm Hg (4·8) in 258 controls. At 24 months, mean reduction in intraocular pressure was 3·8 mm Hg (4·0) in 231 patients assessed in the latanoprost group and 0·9 mm Hg (3·8) in 230 patients assessed in the placebo group. Visual field preservation was significantly longer in the latanoprost group than in the placebo group: adjusted hazard ratio (HR) 0·44 (95% CI 0·28–0·69; p=0·0003). We noted 18 serious adverse events, none attributable to the study drug.

Interpretation
This is the first randomised placebo-controlled trial to show preservation of the visual field with an intraocular-pressure-lowering drug in patients with open-angle glaucoma. The study design enabled significant differences in vision to be assessed in a relatively short observation period

Two-year survival of ART restorations placed in elderly patients: A randomised controlled clinical trial

OBJECTIVES: Older dentate adults are a high caries risk group who could potentially benefit from the use of the atraumatic restorative treatment (ART). This study aimed to compare the survival of ART and a conventional restorative technique (CT) using rotary instruments and a resin-modified glass-ionomer for restoring carious lesions as part of a preventive and restorative programme for older adults after 2 years.

METHODS: In this randomised controlled clinical trial, 99 independently living adults (65-90 years) with carious lesions were randomly allocated to receive either ART or conventional restorations. The survival of restorations was assessed by an independent and blinded examiner 6 months, 1 year and 2 years after restoration placement.

RESULTS: Ninety-six (67.6%) and 121 (76.6%) restorations were assessed in the ART and CT groups, respectively, after 2 years. The cumulative restoration survival percentages after 2 years were 85.4% in the ART and 90.9% in the CT group. No statistically significant between group differences were detected (p=0.2050, logistic regression analysis).

CONCLUSIONS: In terms of restoration survival, ART was as effective as a conventional restorative approach to treat older adults after 2 years. This technique could be a useful tool to provide dental care for older adults particularly in the non-clinical setting. (Trial Registration number: ISRCTN 76299321).

CLINICAL SIGNIFICANCE: The results of this study show that ART presented survival rates similar to conventional restorations in older adults. ART appears to be a cost-effective way to provide dental care to elderly patients, particularly in out of surgery facilities, such as nursing homes.

The impact of rehabilitation using removable partial dentures and functionally orientated treatment on oral health-related quality of life: a randomised controlled clinical trial

OBJECTIVES: This study aimed to compare two different tooth replacement strategies for partially dentate older patients; namely functionally orientated treatment according to the principles of the shortened dental arch (SDA) and conventional treatment using removable partial dentures (RPDs) using a randomised controlled clinical trial. The primary outcome measure for this study was impact on oral health-related quality of life (OHRQoL) measured using the short form of the oral health impact profile (OHIP-14).

METHODS: Patients aged 65 years and older were randomly allocated to two different treatment groups: the RPD group and the SDA group. For the RPD group each patient was restored to complete arches with cobalt-chromium RPDs used to replace missing teeth. For the SDA group, patients were restored to a premolar occlusion of 10 occluding pairs of natural and replacement teeth using resin bonded bridgework (RBB). OHRQoL was measured using the OHIP-14 questionnaire administered at baseline, 1 month, 6 months and 12 months after treatment intervention.

RESULTS: In total, 89 patients completed the RCT: 44 from the RPD group and 45 from the SDA group. Analysis using a mixed model of covariance (ANCOVA) illustrated that treatment according to the SDA concept resulted in significantly better mean OHIP-14 scores compared with RPD treatment (p<0.05). This result was replicated in both treatment centres used in the study.

CONCLUSIONS: In terms of impact on OHRQoL, treatment based on the SDA concept achieved significantly better results than that based on RPDs 12 months after treatment intervention (trial registration no. ISRCTN26302774).

CLINICAL SIGNIFICANCE: Functionally orientated treatment delivery resulted in significantly better outcomes compared to removable dentures in terms of impact on OHRQoL.

Comparison of functionally orientated tooth replacement and removable partial dentures on the nutritional status of partially dentate older patients: a randomised controlled clinical trial

OBJECTIVES: The aims of this study were to conduct a randomised controlled clinical trial (RCT) of partially dentate older adults comparing functionally orientated treatment based on the SDA concept with conventional treatment using RPDs to replace missing natural teeth. The two treatment strategies were evaluated according to their impact on nutritional status measured using haematological biomarkers.

METHODS: A randomised controlled clinical trial (RCT) was conducted of partially dentate patients aged 65 years and older (Trial Registration no. ISRCTN26302774). Each patient provided haematological samples which were screened for biochemical markers of nutritional status. Each sample was tested in Cork University Hospital for serum Albumin, serum Cholesterol, Ferritin, Folate, Vitamin B12 and 25-hydroxycholecalciferol (Vitamin D).

RESULTS: A mixed model analysis of covariance (ANCOVA) indicated that for Vitamin B12 (p=0.9392), serum Folate (p=0.5827), Ferritin (p=0.6964), Albumin (p=0.8179), Serum Total Cholesterol (p=0.3670) and Vitamin D (p=0.7666) there were no statistically significant differences recorded between the two treatment groups. According to the mixed model analysis of covariance (ANCOVA) for Vitamin D there was a significant difference between levels recorded at post-operative time points after treatment intervention (p=0.0470). There was an increase of 7% in 25-hydroxycholecalciferol levels recorded at 6 months compared to baseline (p=0.0172). There was no further change in recorded levels at 12 months (p=0.6482) and these increases were similar within the two treatment groups (p>0.05).

CONCLUSIONS: The only measure which illustrated consistent significant improvements in nutritional status for either group were Vitamin D levels. However no significant difference was recorded between the two treatment groups.

CLINICAL SIGNIFICANCE: Functionally orientated prosthodontic rehabilitation for partially dentate older patients was no worse than conventional removable partial dentures in terms of impact on nutritional status.

A cluster randomised controlled trial evaluation and cost-effectiveness analysis of the Roots of Empathy schools-based programme for improving social and emotional wellbeing outcomes among 8-9 year olds in Northern Ireland

A substantial body of evidence suggest that well designed school based prevention programmes can be effective in improving a variety of social, health and academic outcomes for children and young people. This poster presents the methodology for evaluating the Roots of Empathy (ROE) programme. ROE is a universal programme delivered on a whole-class basis for one academic year. It consists of 27 lessons that run over a school year and is based around a monthly classroom visit by an infant and parent, typically recruited from the local community, whom the class 'adopts' at the start of the school year. The evaluation aims to evaluate the immediate and longer term impact of ROE on social and emotional wellbeing outcomes among 8-9 year old pupils, as well as evaluate the cost-effectiveness of the programme.

A randomised controlled trial evaluation of the Lifestart parenting programme in Ireland

This randomised controlled trial evaluated the impact of the Lifestart parenting initiative, a five-year home visiting programme, on parent and child outcomes. 424 parents and children aged less than 12 months were recruited from across Ireland and randomly assigned to either the intervention or control group. The intervention group received the programme for five years; the control group did not, but continued as normal. Both groups were tested at three time points: pre-test, mid-point (child aged 3 years) and post-test (child aged 5 years). Post-test data collection is still on-going and will be completed by November 2014. Indicative findings (using available data) are presented here, however the analysis of the full dataset will be presented at the April 2015 meeting.