Lithium in patients with amyotrophic lateral sclerosis (LiCALS): a phase 3 multicentre, randomised, double-blind, placebo-controlled trial.

BACKGROUND: Lithium has neuroprotective effects in cell and animal models of amyotrophic lateral sclerosis (ALS), and a small pilot study in patients with ALS showed a significant effect of lithium on survival. We aimed to assess whether lithium improves survival in patients with ALS. METHODS: The lithium carbonate in amyotrophic lateral sclerosis (LiCALS) trial is a randomised, double-blind, placebo-controlled trial of oral lithium taken daily for 18 months in patients with ALS. Patients aged at least 18 years who had ALS according to the revised El Escorial criteria, had disease duration between 6 and 36 months, and were taking riluzole were recruited from ten centres in the UK. Patients were randomly assigned (1:1) to receive either lithium or matched placebo tablets. Randomisation was via an online system done at the level of the individual by block randomisation with randomly varying block sizes, stratified by study centre and site of disease onset (limb or bulbar). All patients and assessing study personnel were masked to treatment assignment. The primary endpoint was the rate of survival at 18 months and was analysed by intention to treat. This study is registered with Eudract, number 2008-006891-31. FINDINGS: Between May 26, 2009, and Nov 10, 2011, 243 patients were screened, 214 of whom were randomly assigned to receive lithium (107 patients) or placebo (107 patients). Two patients discontinued treatment and one died before the target therapeutic lithium concentration could be achieved. 63 (59%) of 107 patients in the placebo group and 54 (50%) of 107 patients in the lithium group were alive at 18 months. The survival functions did not differ significantly between groups (Mantel-Cox log-rank χ(2) on 1 df=1·64; p=0·20). After adjusting for study centre and site of onset using logistic regression, the relative odds of survival at 18 months (lithium vs placebo) was 0·71 (95% CI 0·40-1·24). 56 patients in the placebo group and 61 in the lithium group had at least one serious adverse event. INTERPRETATION: We found no evidence of benefit of lithium on survival in patients with ALS, but nor were there safety concerns, which had been identified in previous studies with less conventional designs. This finding emphasises the importance of pursuing adequately powered trials with clear endpoints when testing new treatments. FUNDING: The Motor Neurone Disease Association of Great Britain and Northern Ireland.

Fractional urinary fluoride excretion of 6-7-year-old children attending schools in low-fluoride and naturally fluoridated areas in the UK.

F is an important trace element for bones and teeth. The protective effect of F against dental caries is well established. Urine is the prime vehicle for the excretion of F from the body; however, the relationship between F intake and excretion is complex: the derived fractional urinary F excretion (FUFE) aids understanding of this in different age groups. The present study aimed to investigate the relationships between (1) total daily F intake (TDFI) and daily urinary F excretion (DUFE), and (2) TDFI and FUFE in 6-7-year-olds, recruited in low-F and naturally fluoridated (natural-F) areas in north-east England. TDFI from diet and toothbrushing and DUFE were assessed through F analysis of duplicate dietary plate, toothbrushing expectorate and urine samples using a F-ion-selective electrode. FUFE was calculated as the ratio between DUFE and TDFI. Pearson's correlation and regression analysis were used to investigate the relationship between TDFI and FUFE. A group of thirty-three children completed the study; twenty-one receiving low-F water (0·30 mg F/l) and twelve receiving natural-F water (1·06 mg F/l) at school. The mean TDFI was 0·076 (SD 0·038) and 0·038 (SD 0·027) mg/kg per d for the natural-F and low-F groups, respectively. The mean DUFE was 0·017 (SD 0·007) and 0·012 (SD 0·006) mg/kg per d for the natural-F and low-F groups, respectively. FUFE was lower in the natural-F group (30 %) compared with the low-F group (40 %). Pearson's correlation coefficient for (1) TDFI and DUFE was +0·22 (P= 0·22) and for (2) TDFI and FUFE was − 0·63 (P< 0·001). In conclusion, there was no correlation between TDFI and DUFE. However, there was a statistically significant negative correlation between FUFE and TDFI.

Compliance with school F-milk and non-F milk intake in 3 to 4 and 6 to 7-year-old children.

BACKGROUND: Fluoridated (F) milk schemes are employed in six countries to reduce dental caries in children. To maximise their benefits considerable uptake is required. Measuring compliance and understanding contributing factors is important in evaluating the effectiveness of schemes since it can be unclear whether reported sub-optimal fluoride (F) intakes, measured through urinary F excretion, are due to sub-optimal F contents of milks or lack of compliance with consumption. OBJECTIVES: To determine compliance with milk consumption for children receiving non-F or F milk (containing 0.5 or 0.9 mgF per 189 ml carton) and rationalise the use of compliance data for clinical observational or intervention studies involving F milk schemes. RESEARCH DESIGN: Partially randomised, partial cross-over study. PARTICIPANTS: 50 children aged 3-4 and 6-7y consuming non-F (n=50) and F milk (0.5 mgF; n=15 children; 0.9mg F; n=16 children) at school. RESULTS: Mean compliance for both non-F and F milk was > or =90% in each of the groups studied and showed no statistically significant difference for children using both milks. The 95% central range of proportions of milk consumed for groups of individuals was wider for 0.9mgF milk (25% to 100%) than for 0.5 mgF milk (81% to 100%) although the greatest range of variation in compliance for within individual observations was seen for non-F milk consumption and in older children. CONCLUSION: Assessment of compliance with consumption should be included when dental efficacy of F milk consumption is being investigated or evaluated to quantify F exposure from milk. This is important, particularly if a change in the F dose of F milk might be under consideration.

Impact of deprivation on short- and long-term outcomes after colorectal cancer surgery.

BACKGROUND: The aim of the study was to determine the association between short- and long-term outcomes and deprivation for patients undergoing operative treatment for colorectal cancer in the Northern Region of England. METHODS: This was a retrospective analytical study based on the Northern Region Colorectal Cancer Audit Group database for the period 1998-2002. The Index of Multiple Deprivation 2004, an area-based measure, was recalibrated and used to quantify deprivation. Patients were ranked based on their postcode of residence and grouped into five categories. RESULTS: Of 8159 patients in total, 7352 (90·1 per cent) had surgery; 6953 (94·6 per cent) of the 7352 patients underwent tumour resection and 4935 (67·7 per cent) of 7294 had a margin-negative (R0) resection. Deprivation was not associated with age, sex, tumour site, stage or other tumour-related factors. Compared with the most affluent group, the most deprived patients had fewer elective operations (72·9 versus 76·4 per cent; P = 0·014), more adverse co-morbidity (P < 0·001) and fewer curative resections (65·5 versus 71·2 per cent; P < 0·001). In multivariable analysis, deprivation was not an independent predictor of postoperative death (odds ratio (OR) 0·72, 95 per cent confidence interval 0·48 to 1·06; P = 0·101) but it was a predictor of curative resection (OR 1·24, 1·01 to 1·52; P = 0·042), overall survival (HR 0·83, 0·73 to 0·95; P = 0·006) and relative survival (HR 0·74, 0·58 to 0·95; P = 0·023). CONCLUSION: Deprivation, both independently and by influencing other surgical predictors, impacts on short- and long-term outcomes of patients with colorectal cancer.

LIFELAX - diet and LIFEstyle versus LAXatives in the management of chronic constipation in older people: randomised controlled trial.

OBJECTIVES: To investigate the clinical effectiveness and cost-effectiveness of laxatives versus dietary and lifestyle advice, and standardised versus personalised dietary and lifestyle advice. DESIGN: A prospective, pragmatic, three-armed cluster randomised trial with an economic evaluation. SETTING: General practices in England and Scotland, UK. PARTICIPANTS: People aged ≥ 55 years with chronic constipation, living in private households. Participants were identified as those who had been prescribed laxatives three or more times in the previous 12 months, or with a recorded diagnosis of chronic functional constipation. INTERVENTIONS: Prescription of laxatives, with class of laxative and dose at the discretion of the GP and patient (standard care control arm); standardised, non-personalised dietary and lifestyle advice; and, personalised dietary and lifestyle advice, with reinforcement. OUTCOME MEASURES: The primary outcome was the constipation-specific Patient Assessment of Constipation-Symptoms (PAC-SYM)/Patient Assessment of Constipation-Quality of Life (PAC-QOL). RESULTS: The trial planned to recruit and retain 1425 patients from 57 practices (19 per arm); however, only 154 patients were recruited from 19 practices. Due to these low recruitment rates it was not possible to report the conventional trial findings. Baseline characteristics of the sample from data gathered from both postal self-completion questionnaires and face-to-face interviews suggest that our sample experienced very few symptoms of constipation (PAC-SYM) and that the condition itself did not have a major impact upon their quality of life (PAC-QOL). The low level of symptoms of constipation is most likely explained by 90% of the sample using a laxative in the previous week. Most participants in our sample were satisfied with the performance of their laxatives, and levels of anxiety and depression were low. Their fibre consumption was classified as 'moderate' but their average water consumption fell below the recommended guidelines. Daily diaries, completed each day for a period of 6 months, were analysed primarily in terms of overall response rate and item response rates, and the participants accepted this method of data collection. For the economic evaluation, all of the trial arms experienced a reduction in utility, as measured by EQ-5D. There was no statistical evidence to suggest that either the personalised intervention arm or the standardised intervention arm was associated with significant changes in utility at 3 months compared with the control arm. Data on related health-care costs show a cost saving of £13.34 for those in the personalised arm, compared with the control arm, and a smaller cost saving for the standardised arm. These savings primarily occurred because of reduced hospital costs. There was no significant change measured in utility, so the personalised arm appeared to be the preferred course, producing the greatest cost savings. CONCLUSIONS: Due to the low number of participants in the trial, no firm conclusions could be drawn about the effectiveness of the interventions. However, a number of factors that contributed to the conduct and progress of the trial are highlighted, which may be relevant to others conducting research on a similar topic or population. TRIAL REGISTRATION: ISRCTN73881345. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 14, No. 52. See the HTA programme website for further project information.

Developing a primary dental care outreach (PDCO) course--part 2: perceptions of dental students.

BACKGROUND: The perspective of participating students in a primary dental care outreach (PDCO) course, with regard to clinical and educational value, has informed course development and delivery. OBJECTIVES: To evaluate students' perception of the PDCO experience including clinical experience gained, teaching and learning and the teaching environment. METHODS: Likert Scale-based questionnaires were completed: (A) prior to the start of PDCO teaching, (B1) after one term, (B2) after one year and (C) for entry year 2001 students at completion. Additionally, a cohort of entry year 2000 students with no PDCO experience was surveyed at the end of their 4th year. Factor Analysis with Crohnbach's alpha was used to investigate perception of (i) confidence and skills in treating child patients, (ii) confidence and skills in treating adult patients; (iii) general clinical skills and experience; (iv) team working. Data from entry years 2000-2003 were analysed using ANOVA and independent sample t-tests. RESULTS: For entry years 2001 and 2002, perceived confidence and skills in treating child patients and general clinical experience increased, although for entry year 2002 students the levels of perceived general confidence and skills achieved after 1 year were similar to the entry year 2000 cohort who had received no PDCO teaching. There was consistently high satisfaction with teamworking. After 2 years in PDCO, 11 of the 13 overall satisfaction scores were over 70%. CONCLUSION: The majority of students perceive PCDO as a valuable component of professional training and development. Further evaluation, including analysis of value for money, would help to inform funding decisions and further curriculum development.

Effect of rinsing with mouthwashes after brushing with a fluoridated toothpaste on salivary fluoride concentration.

The aim of the study was to determine whether rinsing with a mouthwash after brushing with a fluoridated toothpaste affected oral fluoride (F) retention and clearance compared with an oral hygiene regime without mouthwash. In this supervised, single-blind study, 3 regimes were compared: (A) brushing for 1 min with 1 g of 1,450 microg F/g NaF toothpaste followed by rinsing for 5 s with 10 ml water; (B) as A but followed by rinsing for 30 s with 20 ml of 100 mg F/l NaF mouthwash, and (C) as B but rinsing for 30 s with a non-fluoridated mouthwash. Twenty-three adults applied each treatment once in a randomised order, separated by 1-week washout periods, and used a non-fluoridated toothpaste at home prior to and during the study. Whole saliva samples (2 ml), collected before each treatment commenced and 10, 20, 30, 60, 90 and 120 min afterwards, were subsequently analysed for fluoride by ion-specific electrode. The mean (SD) back-transformed log (area under salivary F clearance curve) values were: A = 2.36 (+3.37, -1.39), B = 2.54 (+2.72, -1.31) and C = 1.19 (+1.10, -0.57) mmol F/l x min, respectively. The values for regimes A and B were statistically significantly greater than that for regime C (p < 0.001; paired t test). These findings suggest that use of a non-F mouthwash after toothbrushing with a F toothpaste may reduce the anticaries protection provided by toothbrushing with a F toothpaste alone. The use of a mouthwash with at least 100 mg F/l should minimise this risk.

Impaired attention predicts falling in Parkinson's disease.

BACKGROUND: Cognitive deficits, in particular deficits of attention and executive function, may affect postural sway and balance in Parkinson's disease (PD). Our objective was to determine whether measures of attention were associated with falls in a large cohort of subjects with PD studied prospectively. METHODS: Patients meeting UK PD Society Brain Bank Criteria were included. Assessment included UPDRS III and the Cognitive Drug Research computerised assessment battery (CDR) from which Power of Attention, Continuity of Attention, cognitive reaction time and reaction time variability were derived. Falls were assessed prospectively using monthly fall diaries returned over a year following baseline assessment. RESULTS: One hundred and sixty four subjects completed fall diary datasets. One hundred and three (63%) fell one or more times during the 12 month period. Regression analysis revealed an association of fall frequency with poorer Power of Attention and increased reaction time variability, which was retained after correcting for UPDRS scores. CONCLUSIONS: Reduced power of attention and increased reaction time variability are associated with increased fall frequency in PD. This has implications for the identification of those most at risk of falling, and for the management and prevention of falls in this patient group.

Optimising outcome assessment of voice interventions, II: Sensitivity to change of self-reported and observer-rated measures.

OBJECTIVES: A wide range of well validated instruments is now available to assess voice quality and voice-related quality of life, but comparative studies of the responsiveness to change of these measures are lacking. The aim of this study was to assess the responsiveness to change of a range of different measures, following voice therapy and surgery. DESIGN: Longitudinal, cohort comparison study. SETTING: Two UK voice clinics. PARTICIPANTS: One hundred and forty-four patients referred for treatment of benign voice disorders, 90 undergoing voice therapy and 54 undergoing laryngeal microsurgery. MAIN OUTCOME MEASURES: Three measures of self-reported voice quality (the vocal performance questionnaire, the voice handicap index and the voice symptom scale), plus the short form 36 (SF 36) general health status measure and the hospital anxiety and depression score. Perceptual, observer-rated analysis of voice quality was performed using the grade-roughness-breathiness-asthenia-strain scale. We compared the effect sizes (i.e. responsiveness to change) of the principal subscales of all measures before and after voice therapy or phonosurgery. RESULTS: All three self-reported voice measures had large effect sizes following either voice therapy or surgery. Outcomes were similar in both treatment groups. The effect sizes for the observer-rated grade-roughness-breathiness-asthenia-strain scale scores were smaller, although still moderate. The roughness subscale in particular showed little change after therapy or surgery. Only small effects were observed in general health and mood measures. CONCLUSION: The results suggest that the use of a voice-specific questionnaire is essential for assessing the effectiveness of voice interventions. All three self-reported measures tested were capable of detecting change, and scores were highly correlated. On the basis of this evaluation of different measures' sensitivities to change, there is no strong evidence to favour either the vocal performance questionnaire, the voice handicap index or the voice symptom scale.

Comorbidity in nasopharyngeal carcinoma: a preliminary communication on the prevalence, descriptive distribution and impact on outcome.

OBJECTIVES: Comorbidity has been shown to be a determinant in treatment selection and survival in squamous cell cancer of the head and neck at various subsites. The objective of this study is to analyse the effect of comorbidity burden on outcome of nasopharyngeal cancer using the Adult Comorbidity Evaluation-27 (ACE-27) instrument. DESIGN: Retrospective analysis. SETTING: Tertiary care centres. PARTICIPANTS: This study included 59 patients diagnosed with nasopharyngeal carcinoma between 1989-2003 in the North-East of England. Exclusion criteria included non-squamous neoplasms of the nasopharynx. Comorbidity was assessed retrospectively from the notes using standard validated techniques described earlier. Tumour, treatment and survival data were obtained from prospective databases. Data was analysed using SPSS for Windows. MAIN OUTCOME MEASURES: Comorbidity and outcome of treatment. RESULTS: Comorbid burden was evident in 44% of patients, with moderate or severe comorbidity in 19%. The cardiovascular system was the most commonly affected system (27%). Cox's proportional hazard model showed age and stage of tumour to have an impact on disease specific survival. Comorbidity was not seen to predict the outcome independent of other factors. The sample size of this study is powered to detect only medium to large effects. We estimate that 614 subjects will be needed to detect a correlation coefficient of 0.1 with 80% power, assuming a type 1 error rate of 5%. CONCLUSION: This study shows for the first time that the comorbidity burden seen in nasopharyngeal cancer does not affect prognosis independent of the TNM staging.

Optimising outcome assessment of voice interventions, I: Reliability and validity of three self-reported scales.

BACKGROUND: There is an increasing choice of voice outcome research tools, but good comparative data are lacking. OBJECTIVE: To evaluate the reliability and validity of three voice-specific, self-reported scales. DESIGN: Longitudinal, cohort comparison study. SETTING: Two UK voice clinics: the Freeman Hospital, Newcastle upon Tyne, and the Glasgow Royal Infirmary. PARTICIPANTS: One hundred and eighty-one patients presenting with dysphonia. MAIN OUTCOME MEASURES: All patients completed the vocal performance questionnaire, the voice handicap index and the voice symptom scale. For comparison, each patient's voice was recorded and assessed perceptually using the grade-roughness-breathiness-aesthenia-strain scale. The reliability and validity of the three self-reported vocal performance measures were assessed in all subjects, while 50 completed the questionnaires again to assess repeatability. RESULTS: The results of the 170 participants with completed data sets showed that all three questionnaires had high levels of internal consistency (Cronbach's alpha = 0.81-0.95) and repeatability (voice handicap index = 0.83; vocal performance questionnaire = 0.75; voice symptom scale = 0.63). Concurrent and criterion validity were also good, although, of the grade-roughness-breathiness-aesthenia-strain subscales, roughness was the least well correlated with the self-reported measures. CONCLUSION: The vocal performance questionnaire, the voice handicap index and the voice symptom scale are all reliable and valid instruments for measuring the patient-perceived impact of a voice disorder.

Pulpal anaesthesia for mandibular permanent first molar teeth: a double-blind randomized cross-over trial comparing buccal and buccal plus lingual infiltration injections in volunteers.

AIM: To compare the efficacy of buccal and buccal plus lingual infiltration anaesthesia for permanent mandibular first molars. METHODOLOGY: Thirty one healthy adult volunteers received each of the following methods of anaesthesia for a mandibular first molar tooth in a randomised order, 1) Buccal infiltration of 1.8 mL and needle penetration lingually. 2) Buccal infiltration of 0.9 mL, plus lingual infiltration of 0.9 mL. Two percent lidocaine with 1:100,000 epinephrine was used. Electrical pulp testing was performed before, and every 2 minutes for 30 minutes after injection. A successful outcome was recorded as the absence of pulp sensation on two or more consecutive maximal pulp tester stimulations (80 microA). Injection discomfort was assessed using visual analogue scales. Data were compared with McNemar and Wilcoxon Signed Ranks tests. RESULTS: Buccal infiltration was successful in 38.7% of cases compared to 32.3% after combined infiltrations; the difference was not significant (P = 0.63). Buccal infiltration produced more episodes of no response to maximum stimulation than buccal and lingual infiltrations (129 and 114 respectively), this difference was not significant (P = 0.11). Peak anaesthetic effect occurred around 10-14 minutes after injection. There was no difference in injection discomfort between buccal injections of 0.9 mL and 1.8 mL of solution (P = 0.90). Lingual injection was more uncomfortable than lingual penetration (P = O.O02). CONCLUSIONS: Buccal and buccal plus lingual infiltrations did not differ in their efficacy in producing anaesthesia of permanent first molar teeth.

Silencing the snorers: no gain without pain?

OBJECTIVE: To compare the estimated effects of conservative surgery to those of a mandibular advancement splint (MAS) in the treatment of habitual snoring. METHOD: Prospective, observational, non-randomized cohort study. RESULTS: Adequate follow-up data were available for 88 participants (23 following coblation, 65 after provision of an MAS). The mean reduction in snoring symptoms inventory (SSI) score for the 23 subjects undergoing coblation was 9.83 (+/-standard deviation 11.43). Reported pain duration was greatest with uvula amputation, but uvula coblation did not always adequately reduce its bulk. Of the 65 MAS patients, 39 (60 per cent) used the device regularly, with a mean fall in SSI of 12 (+/-16.4, p=0.001). Approximately one in four patients in both groups achieved a significant fall in SSI (>15 points), and the measured effect sizes were close to 0.75 for both treatments. CONCLUSIONS: Mandibular advancement splints and coblation have similar efficacies. However, their efficacy does not match that of radical surgery.

Measuring plaque in clinical trials: index or weight?

AIM: To explore the possibility of using plaque weight rather than plaque index as a more objective, clinical outcome measure in periodontal clinical trials. MATERIALS AND METHODS: The study initially recruited 12 healthy volunteers who abstained from tooth cleaning for 24 h on each of the three occasions and then for 48 h on each of a further three occasions to accumulate plaque. On a further three visits, the subjects abstained from tooth cleaning for 24 h and then brushed with a powered toothbrush for 2 min. A split-mouth design with target teeth was adopted and plaque was first scored separately on each side of the mouth using the Turesky modification of the Quigley and Hein plaque index. Post-brushing residual plaque was also scored after tooth cleaning. Inter-proximal plaque was dried, removed, pooled and weighed: on one side of the mouth from the entire inter-proximal surfaces; and from beneath the contact points on the contra-lateral side. RESULTS: Discriminant validity showed the index to have an advantage over weight in discerning between 24- and 48-h plaque deposits, and between 24-h plaque and post-brushing plaque. Test-retest validity confirmed that for repeated plaque growth, variability within subjects was greater than the variability between subjects. There was an association between plaque weight and plaque index although the regression lines were non-linear. CONCLUSION: There appears to be no significant advantage in using plaque weight in periodontal clinical trials.

Bioavailability of fluoride in drinking water: a human experimental study.

It has been suggested that systemic fluoride absorption from drinking water may be influenced by the type of fluoride compound in the water and by water hardness. Using a human double-blind cross-over trial, we conducted this study to measure c(max), T(max), and Area Under the Curve (AUC) for plasma F concentration against time, following the ingestion of naturally fluoridated hard and soft waters, artificially fluoridated hard and soft waters, and a reference water. Mean AUC over 0 to 8 hours was 1330, 1440, 1679, 1566, and 1328 ng F.min.mL(-1) for naturally fluoridated soft, naturally fluoridated hard, artificially fluoridated soft, artificially fluoridated hard, and reference waters, respectively, with no statistically significant differences among waters for AUC, c(max), or T(max). Any differences in fluoride bioavailability between drinking waters in which fluoride is present naturally or added artificially, or the waters are hard or soft, were small compared with large within- and between-subject variations in F absorption. Abbreviations used: F, fluoride; AUC, Area under the Curve for plasma F concentration against time; AUC(0-3), Area under the Curve for plasma F concentration against time for 0 to 3 hours following water ingestion; AUC(0-8), Area under the Curve for plasma F concentration against time for 0 to 8 hours following water ingestion; c(max), maximum plasma F concentration corrected for baseline plasma F and dose (i.e., F concentration of individual waters); T(max), time of c(max).

A double-blind, crossover study of Biotène Oralbalance and BioXtra systems as salivary substitutes in patients with post-radiotherapy xerostomia.

This study assessed the efficacy of the Bioxtra (BX) and Biotène Oralbalance (OB) systems in the treatment of post-radiotherapy xerostomia. In a double-blind, crossover study, 20 patients with post-radiotherapy xerostomia were randomly allocated to receive either OB then BX, or vice versa, each product for 2 weeks, with a 1 week wash-out period in between. Subject-based dry mouth scores derived from 100-mm visual analogue scales were recorded at days 0 and 14 of each 2-week period, together with subjective perception of changes in dry mouth symptoms. Both treatments were effective, resulting in reduction of visual analogue scale scores from day 0-14. Between-groups comparisons identified that BX achieved significantly better improvements compared with OB for the perception of dry mouth and improvements in speech and was also rated as more pleasant to use than OB (P < 0.05). In conclusion, both treatments were effective in alleviating the symptoms of post-radiotherapy xerostomia, although BX achieved superiority in some of the outcomes assessed compared with OB.

A comparison of functional, patient-based scores in subacromial impingement.

The goal of this study was to compare the Oxford Shoulder Score (OSS), the Shoulder Pain and Disability Index (SPADI), and the Short Form 36 (SF-36) for their correlation, agreement, sensitivity to change, and test-retest reliability in patients with a clinical diagnosis of subacromial impingement. All patients attending a specialist subacromial impingement clinic over a 6-month period completed the OSS, SPADI, and SF-36 at each visit. A total of 323 sets of observations were recorded in 110 patients. The first 38 of these patients were also sent the questionnaires to complete before their visit. There was good correlation between the OSS and SPADI scores (correlation coefficient = 0.85) and good agreement between the scores on each scale (weighted kappa = 0.79). The correlation with total SF-36 was poor (0.37 for OSS and 0.26 for SPADI). The OSS and SPADI showed good effect sizes compared with the total SF-36 score and good test-retest reliability. These data support the use of the OSS or SPADI in patients with subacromial impingement.

The dental attitudes, knowledge and health practices of patients with Juvenile Idiopathic Arthritis.

AIM: To investigate the dental attitudes, knowledge and dental health practices of children and adults with a previous diagnosis of Juvenile Idiopathic Arthritis (JIA). STUDY DESIGN: A self-completion questionnaire. METHODS: Ninety-one children and 82 adults with JIA were age and gender matched with 152 healthy controls. For those below the age of 16 years, the parents' attitude, knowledge and dental health practices were investigated by the questionnaire. The adult subjects and controls completed an identical questionnaire assessing their own attitude, knowledge and dental health practices. RESULTS: Response rates of 84% and 75% were achieved for the subject and controls respectively. Both groups responded similarly to questions assessing perception of different medical conditions. The majority of respondents thought leukaemia was a very serious condition. Twenty-seven percent of subjects and 34% of controls felt dental decay was "slightly or not serious". Ninety percent of subjects and 93% of controls knew having sweet snacks during the day would harm teeth, but fewer were sure that eating sweet foods at mealtimes only would help reduce decay. The majority of respondents (63% and 56% respectively) did not know whether children should receive fluoride tablets but the majority of subjects in both groups had attended a dentist within the last year. STATISTICS: Descriptive analyses and chi-squared analysis were undertaken. A p-value of < or =0.01 was taken as strong evidence of a difference between groups. CONCLUSION: The perception of health and illness by both groups was appropriate. The questions investigating dental knowledge revealed understanding of the basic messages of prevention of dental disease, but finer detail appeared less well understood. Responses concerning dental health confirmed positive attitudes towards good dental health habits. The benefits of brushing with fluoride toothpaste were known, and the majority toothbrushed daily and received dental care within the previous year.

The reliability and sensitivity to change of acoustic measures of voice quality.

This study aimed to evaluate the reliability and sensitivity to change of three commonly used acoustic parameters as measured by the Multi-Dimensional Voice Programme (MDVP); jitter, shimmer and noise-to-harmonic ratio. A total of 231 subjects' voices were recorded and analysed. The sample comprised 145 dysphonic patients who received intervention (surgery or voice therapy), 36 dysphonic patients who received no intervention, and 50 non-dysphonic (normal) subjects. All voices were recorded and analysed on two occasions (before and after treatment, or test-retest assessment) using a standard procedure. These data were analysed using standard psychometric procedures for assessing reliability and responsiveness. The acoustic analysis measures demonstrated poor to moderate reliability and effect size with respect to their sensitivity to change. Caution should be exercised in the injudicious use of computer-based acoustic analysis systems as an isolated measure of voice outcome in any clinical trial of interventions aimed at improving voice quality.

Optimizing the assessment of quality of life after laryngeal cancer treatment.

Reports of the impact of larynx cancer treatment modality on quality of life are conflicting, in part due to varying study methodology. The aims of this study were to (1) provide preliminary comparisons of quality of life following radiotherapy or combination therapy; (2) evaluate a number of measures of quality of life and thereby (3) inform future prospective studies. Thirty-six laryngeal cancer patients, 24 following radiotherapy, 12 following radiotherapy and laryngectomy completed the Functional Assessment of Cancer Therapy (FACT) - General/Head and Neck subscale; Nottingham Health Profile (NHP); and the Hospital Anxiety and Depression scale (HAD), three to 12 months post-treatment. Results showed trends towards a less good quality of life in the combined therapy group over a wide range of outcomes, significant for the disease specific FACT head and neck subscale, NHP emotion (p = 0.04) and isolation (p = 0.027). To the authors' knowledge, however, this is the first demonstration of greater impact of laryngeal cancer on quality of life in younger subjects, who had lower scores among others on emotional wellbeing (p = 0.015) and anxiety (p = 0.035). Younger patients thus appear more likely to need more intensive support through treatment. Many of the physical and psychosocial domains derived from the three tools used were highly correlated. In other words, given the known high morbidity of the disease and its treatment, the selection of tools for head and neck quality of life assessment may be much less important than their universal application.