Balance Right in Multiple Sclerosis (BRiMS): a feasibility randomised controlled trial of a falls prevention programme.

BACKGROUND: Balance, mobility impairments and falls are problematic for people with multiple sclerosis (MS). The "Balance Right in MS (BRiMS)" intervention, a 13-week home and group-based exercise and education programme, aims to improve balance and minimise falls. This study aimed to evaluate the feasibility of undertaking a multi-centre randomised controlled trial and to collect the necessary data to design a definitive trial. METHODS: This randomised controlled feasibility study recruited from four United Kingdom NHS clinical neurology services. Patients ≥ 18 years with secondary progressive MS (Expanded Disability Status Scale 4 to 7) reporting more than two falls in the preceding 6 months were recruited. Participants were block-randomised to either a manualised 13-week education and exercise programme (BRiMS) plus usual care, or usual care alone. Feasibility assessment evaluated recruitment and retention rates, adherence to group assignment and data completeness. Proposed outcomes for the definitive trial (including impact of MS, mobility, quality of life and falls) and economic data were collected at baseline, 13 and 27 weeks, and participants completed daily paper falls diaries. RESULTS: Fifty-six participants (mean age 59.7 years, 66% female, median EDSS 6.0) were recruited in 5 months; 30 randomised to the intervention group. Ten (18%) participants withdrew, 7 from the intervention group. Two additional participants were lost to follow up at the final assessment point. Completion rates were > 98% for all outcomes apart from the falls diary (return rate 62%). After adjusting for baseline score, mean intervention-usual care between-group differences for the potential primary outcomes at week 27 were MS Walking Scale-12v2: - 7.7 (95% confidence interval [CI] - 17.2 to 1.8) and MS Impact Scale-29v2: physical 0.6 (CI - 7.8 to 9), psychological - 0.4 (CI - 9.9 to 9). In total, 715 falls were reported, rate ratio (intervention:usual care) for falls 0.81 (0.41 to 2.26) and injurious falls 0.44 (0.41 to 2.23). CONCLUSIONS: Procedures were practical, and retention, programme engagement and outcome completion rates satisfied a priori progression criteria. Challenges were experienced in completion and return of daily falls diaries. Refinement of methods for reporting falls is therefore required, but we consider a full trial to be feasible. TRIAL REGISTRATION: ISRCTN13587999 Date of registration: 29 September 2016.

The impact of emergency department patient-controlled analgesia (PCA) on the incidence of chronic pain following trauma and non-traumatic abdominal pain.

The effect of patient-controlled analgesia during the emergency phase of care on the prevalence of persistent pain is unkown. We studied individuals with traumatic injuries or abdominal pain 6 months after hospital admission via the emergency department using an opportunistic observational study design. This was conducted using postal questionnaires that were sent to participants recruited to the multi-centre pain solutions in the emergency setting study. Patients with prior chronic pain states or opioid use were not studied. Questionnaires included the EQ5D, the Brief Pain Inventory and the Hospital Anxiety and Depression scale. Overall, 141 out of 286 (49% 95%CI 44-56%) patients were included in this follow-up study. Participants presenting with trauma were more likely to develop persistent pain than those presenting with abdominal pain, 45 out of 64 (70%) vs. 24 out of 77 (31%); 95%CI 24-54%, p < 0.001. There were no statistically significant associations between persistent pain and analgesic modality during hospital admission, age or sex. Across both abdominal pain and traumatic injury groups, participants with persistent pain had lower EQ5D mobility scores, worse overall health and higher anxiety and depression scores (p < 0.05). In the abdominal pain group, 13 out of 50 (26%) patients using patient-controlled analgesia developed persistent pain vs. 11 out of 27 (41%) of those with usual treatment; 95%CI for difference (control - patient-controlled analgesia) -8 to 39%, p = 0.183. Acute pain scores at the time of hospital admission were higher in participants who developed persistent pain; 95%CI 0.7-23.6, p = 0.039. For traumatic pain, 25 out of 35 (71%) patients given patient-controlled analgesia developed persistent pain vs. 20 out of 29 (69%) patients with usual treatment; 95%CI -30 to 24%, p = 0.830. Persistent pain is common 6 months after hospital admission, particularly following trauma. The study findings suggest that it may be possible to reduce persistent pain (at least in patients with abdominal pain) by delivering better acute pain management. Further research is needed to confirm this hypothesis.

A pilot randomised controlled trial investigating a mindfulness-based stress reduction (MBSR) intervention in individuals with pulmonary arterial hypertension (PAH): the PATHWAYS study.

BACKGROUND: Pulmonary arterial hypertension (PAH) is an uncommon condition with progressive heart failure and premature death. Treatment costs up to £120,000 per patient per year, and the psychological burden of PAH is substantial. Mindfulness-based stress reduction (MBSR) is an intervention with the potential to reduce this burden, but to date, it has not been applied to people with pulmonary hypertension. We wished to determine whether a trial of MBSR for people with PAH would be feasible. METHODS: A customised gentle MBSR programme of eight sessions was developed for people with physical disability due to PAH, and they were randomised to group-based MBSR or treatment as usual. The completeness of outcome measures including Beck Anxiety Index, Beck Depression Inventory and standard physical assessment at 3 months after randomisation were recorded. Health care utilisation was measured. Attendance at the sessions and the costs involved in delivering the intervention were assessed. Semi-structured interviews were conducted to explore the acceptability of the MBSR intervention and when appropriate the reasons for trial non-participation. RESULTS: Fifty-two patients were recruited, but only 34 were randomised due to patients finding it difficult to travel to sessions. Twenty-two completed all questionnaires and attended all clinics, both routine and additional in order to collect outcomes measures. The MSBR sessions were delivered in Bristol, Cardiff and London, costing, on average, between £2234 (Cardiff) and £4128 (London) per patient to deliver. Attendance at each session averaged between two patients in Bristol and Cardiff and three in London. For those receiving treatment as usual, clinician blinding was achievable. Interviews revealed that people who attended MBSR found it interesting and helpful in managing their symptoms and minimising the psychological component of their disease. CONCLUSIONS: We found that attendance at group MBSR was poor in people with chronic PAH within the context of a trial. Achieving better MBSR intervention attendance or use of an Internet-based programme might maximise the benefit of MBSR.

Balance Right in Multiple Sclerosis (BRiMS): a guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with secondary progressive multiple sclerosis: a protocol for a feasibility randomised controlled trial.

BACKGROUND: Impaired mobility is a cardinal feature of multiple sclerosis (MS) and is rated by people with MS as their highest priority. By the secondary progressive phase, balance, mobility and physical activity levels are significantly compromised; an estimated 70% of people with secondary progressive MS fall regularly. Our ongoing research has systematically developed 'Balance Right in MS' (BRiMS), an innovative, manualised 13-week guided self-management programme tailored to the needs of people with MS, designed to improve safe mobility and minimise falls. Our eventual aim is to assess the clinical and cost effectiveness of BRiMS in people with secondary progressive MS by undertaking an appropriately statistically powered, multi-centre, assessor-blinded definitive, randomised controlled trial. This feasibility study will assess the acceptability of the intervention and test the achievability of running such a definitive trial. METHODS/DESIGN: This is a pragmatic multi-centre feasibility randomised controlled trial with blinded outcome assessment. Sixty ambulant people with secondary progressive MS who self-report two or more falls in the previous 6 months will be randomly allocated (1:1) to either the BRiMS programme plus usual care or to usual care alone. All participants will be assessed at baseline and followed up at 15 weeks and 27 weeks post-randomisation. The outcomes of this feasibility trial include:Feasibility outcomes, including trial recruitment, retention and completionAssessment of the proposed outcome measures for the anticipated definitive trial (including measures of walking, quality of life, falls, balance and activity level)Measures of adherence to the BRiMS programmeData to inform the economic evaluation in a future trialProcess evaluation (assessment of treatment fidelity and qualitative evaluation of participant and treating therapist experience). DISCUSSION: The BRiMS intervention aims to address a key concern for MS service users and providers. However, there are several uncertainties which need to be addressed prior to progressing to a full-scale trial, including acceptability of the BRiMS intervention and practicality of the trial procedures. This feasibility trial will provide important insights to resolve these uncertainties and will enable a protocol to be finalised for use in the definitive trial. TRIAL REGISTRATION: ISRCTN13587999.

The cost-effectiveness of patient-controlled analgesia vs. standard care in patients presenting to the Emergency Department in pain, who are subsequently admitted to hospital.

The clinical effectiveness of patient-controlled analgesia has been demonstrated in a variety of settings. However, patient-controlled analgesia is rarely utilised in the Emergency Department. The aim of this study was to compare the cost-effectiveness of patient-controlled analgesia vs. standard care in participants admitted to hospital from the Emergency Department with pain due to traumatic injury or non-traumatic abdominal pain. Pain scores were measured hourly for 12 h using a visual analogue scale. Cost-effectiveness was measured as the additional cost per hour in moderate to severe pain avoided by using patient-controlled analgesia rather than standard care (the incremental cost-effectiveness ratio). Sampling variation was estimated using bootstrap methods and the effects of parameter uncertainty explored in a sensitivity analysis. The cost per hour in moderate or severe pain averted was estimated as £24.77 (€29.05, US$30.80) (bootstrap estimated 95%CI £8.72 to £89.17) for participants suffering pain from traumatic injuries and £15.17 (€17.79, US$18.86) (bootstrap estimate 95%CI £9.03 to £46.00) for participants with non-traumatic abdominal pain. Overall costs were higher with patient-controlled analgesia than standard care in both groups: pain from traumatic injuries incurred an additional £18.58 (€21.79 US$23.10) (95%CI £15.81 to £21.35) per 12 h; and non-traumatic abdominal pain an additional £20.18 (€23.67 US$25.09) (95%CI £19.45 to £20.84) per 12 h.

Surgical timing after chemoradiotherapy for rectal cancer, analysis of technique (STARRCAT): results of a feasibility multi-centre randomized controlled trial.

BACKGROUND: The optimal time of rectal resection after long-course chemoradiotherapy (CRT) remains unclear. A feasibility study was undertaken for a multi-centre randomized controlled trial evaluating the impact of the interval after chemoradiotherapy on the technical complexity of surgery. METHODS: Patients with rectal cancer were randomized to either a 6- or 12-week interval between CRT and surgery between June 2012 and May 2014 (ISRCTN registration number: 88843062). For blinded technical complexity assessment, the Observational Clinical Human Reliability Analysis technique was used to quantify technical errors enacted within video recordings of operations. Other measured outcomes included resection completeness, specimen quality, radiological down-staging, tumour cell density down-staging and surgeon-reported technical complexity. RESULTS: Thirty-one patients were enrolled: 15 were randomized to 6 and 16-12 weeks across 7 centres. Fewer eligible patients were identified than had been predicted. Of 23 patients who underwent resection, mean 12.3 errors were observed per case at 6 weeks vs. 10.7 at 12 weeks (p = 0.401). Other measured outcomes were similar between groups. CONCLUSIONS: The feasibility of measurement of operative performance of rectal cancer surgery as an endpoint was confirmed in this exploratory study. Recruitment of sufficient numbers of patients represented a challenge, and a proportion of patients did not proceed to resection surgery. These results suggest that interval after CRT may not substantially impact upon surgical technical performance.

Impact of analgesic modality on stress response following laparoscopic colorectal surgery: a post-hoc analysis of a randomised controlled trial.

BACKGROUND: Epidural analgesia is perceived to modulate the stress response after open surgery. This study aimed to explore the feasibility and impact of measuring the stress response attenuation by post-operative analgesic modalities following laparoscopic colorectal surgery within an enhanced recovery after surgery (ERAS) protocol. METHODS: Data were collected as part of a double-blinded randomised controlled pilot trial at two UK sites. Patients undergoing elective laparoscopic colorectal resection were randomised to receive either thoracic epidural analgesia (TEA) or continuous local anaesthetic infusion to the extraction site via wound infusion catheter (WIC) post-operatively. The aim of this study was to measure the stress response to the analgesic modality by measuring peripheral venous blood samples analysed for serum concentrations of insulin, cortisol, epinephrine and interleukin-6 at induction of anaesthesia, at 3, 6, 12 and 24 h after the start of operation. Secondary endpoints included mean pain score in the first 48 h, length of hospital stay, post-operative complications and 30-day re-admission rates. RESULTS: There was a difference between the TEA and WIC groups that varies across time. In the TEA group, there was significant but transient reduced level of serum epinephrine and a higher level of insulin at 3 and 6 h. In the WIC, there was a significant reduction of interleukin-6 values, especially at 12 h. There was no significant difference observed in the other endpoints. CONCLUSIONS: There is a significant transient attenuating effect of TEA on stress response following laparoscopic colorectal surgery and within ERAS as expressed by serum epinephrine and insulin levels. Continuous wound infusion with local anaesthetic, however, attenuates cytokine response as expressed by interleukin-6.

Feasibility study of analgesia via epidural versus continuous wound infusion after laparoscopic colorectal resection.

BACKGROUND: With the adoption of enhanced recovery and emerging new modalities of analgesia after laparoscopic colorectal resection (LCR), the role of epidural analgesia has been questioned. This pilot trial assessed the feasibility of a randomized controlled trial (RCT) comparing epidural analgesia and use of a local anaesthetic wound infusion catheter (WIC) following LCR. METHODS: Between April 2010 and May 2011, patients undergoing elective LCR in two centres were randomized to analgesia via epidural or WIC. Sham procedures were used to blind surgeons, patients and outcome assessors. The primary outcome was the feasibility of a large RCT, and all outcomes for a definitive trial were tested. The success of blinding was assessed using a mixed-methods approach. RESULTS: Forty-five patients were eligible, of whom 34 were randomized (mean(s.d.) age 70(11·8) years). Patients were followed up per-protocol; there were no deaths, and five patients had a total of six complications. Challenges with capturing pain data were identified and resolved. Mean(s.d.) pain scores on the day of discharge were 1·9(3·1) in the epidural group and 0·7(0·7) in the WIC group. Median length of stay was 4 (range 2-35, interquartile range 3-5) days. Mean use of additional analgesia (intravenous morphine equivalents) was 12 mg in the WIC arm and 9 mg in the epidural arm. Patient blinding was successful in both arms. Qualitative interviews suggested that patients found participation in the trial acceptable and that they would consider participating in a future trial. CONCLUSION: A blinded RCT investigating the role of epidural and WIC administration for postoperative analgesia following LCR is feasible. Rigorous standard operating procedures for data collection are required.

Screening for cystic fibrosis-related diabetes: a systematic review.

BACKGROUND: Cystic fibrosis (CF) is an inherited disease that leads to damage to lungs, pancreas and other organs. Most people with CF die prematurely from lung disease, but survival has improved markedly over the decades and it is estimated that children born with CF now will live to an average age of 50 years. CF-related diabetes (CFRD) is due to damage to the pancreas, which, over time, loses its capacity to produce sufficient insulin. CFRD is becoming more common owing to the improved survival of people with CF. OBJECTIVES: The initial aim was to review the methods for screening for CFRD, which can be symptomless but still be causing harm. As the aim of screening and early detection is to allow earlier treatment, a second aim was to assess the effectiveness of treatments. However, during the review it became clear that there were problems with how CFRD is defined, uncertainty about when hyperglycaemia should be treated. DATA SOURCES: Details of relevant studies were obtained from the usual bibliometric databases - MEDLINE (1950-2008), EMBASE (1980-2008), The Cochrane Library (all sections), Web of Science (1970-2008). Websites of relevant bodies were searched for guidelines and reports. Conference abstracts were searched. Expert co-authors identified key papers. REVIEW METHODS: Systematic reviews of treatments and screening tests. Screening studies were data extracted if they provided sufficient data to construct 2 × 2 tables. Other screening studies were described in narrative manner. The background to CF and CFRD were described in a narrative manner, as was Chapter 2 on problems with defining CFRD. A model was constructed for cost-effectiveness analysis, but was not used because of lack of data. RESULTS: Diabetes is usually defined based on the level of blood glucose (BG) at which the risk of retinopathy occurs. For CFRD, it would be better to define it on the level at which the risk of lung disease (pulmonopathy) rises. There seems little place for treatments other than insulin, but the best insulin regimen remains to be confirmed. The best screening test may be by continuous glucose monitoring systems but further evidence is required. Screening may need to detect BG levels of > 8 mmol/l because that may be the level above which pulmonopathy starts in people with CF. LIMITATIONS: The evidence base for treatment is disappointing with few large randomised controlled trials. The key question is when treatment should start, perhaps at the post-prandial hyperglycaemia stage. Research is needed. Until that is done, we cannot be sure what we are screening for, and, therefore, which screening strategy should be used. CONCLUSIONS: The definition of CFRD should probably be based on pulmonopathy risk, rather than using the classical definition of diabetes. That implies that we should be screening for a wider range of hyperglycaemia than in other forms of diabetes, perhaps to detect BG excursions of > 8 mmol/l. Insulin treatment may need to start at lower levels than formerly accepted. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Factors predicting deviation from an enhanced recovery programme and delayed discharge after laparoscopic colorectal surgery.

AIM: The study aimed to identify factors that predict postoperative deviation from an enhanced recovery programme (ERP) and/or delayed discharge following colorectal surgery. METHOD: Data were prospectively collected from all patients undergoing elective laparoscopic colorectal resection between January 2006 and December 2009. They included Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity (POSSUM) variables, body mass index (BMI), sex, preoperative serum albumin, pathology, conversion from a laparoscopic to an open approach and postoperative length of hospital stay. RESULTS: There were 176 patients (90 women) of mean age 68 years. Fifteen (9%) operations were converted from laparoscopic to open. The remainder were completed laparoscopically. Fifty-five (31%) deviated from the ERP, with most failing multiple elements. The most common reason was failure to mobilize, which often occurred in conjunction with paralytic ileus or analgesic failure. Factors independently predicting ERP deviation on multivariate analysis were pathology and intra-operative complications. The median length of stay was 5 days. Sixty-four (36%) patients had a prolonged length of stay that was predicted by age, number of procedures and ERP deviation. CONCLUSION: Pathology and intra-operative complications are independent predictors of ERP deviation. Prolonged length of stay can be predicted by age, multiple procedures and ERP deviation. Failure to mobilize should be considered as a red flag sign prompting further investigation following colorectal resection.

How accurate are doctors, nurses and medical students at predicting life expectancy?

BACKGROUND: Predicted patient life expectancy, based on a patient's medical history, is an important component of medical decision making. This study therefore aimed to determine the consistency, accuracy and precision with which doctors, nurses and medical students predict life expectancy (LE). METHODS: 20 doctors, 20 nurses and 20 medical students (4th and 5th year) independently examined 70 hypothetical patient case scenarios containing age, sex and comorbidity; this included 13 duplicate scenarios. Accuracy and consistency of prediction was assessed by comparison with statistical LE estimates generated using evidence-based actuarial and life insurance industry methods in collaboration with a team of professional actuaries. RESULTS: Doctors, nurses and medical students underestimated LE by a mean (95% confidence interval) of -1.46 (-0.31 to -2.61), -1.79 (-0.52 to -3.06) and -2.24 (-1.16 to -3.32) years with an equivalent root mean squared error (RMSE) of 4.74, 5.49 and 5.08 years respectively. LE predictions were equal to actuarial LE in less than 10% of cases and accurate to within 25% of actuarial LE in less than 45% of cases. Intra-observer reliability was 91%, 85% and 87% for doctors, nurses and medical students respectively. Inter-observer reliability was 66%, 57% and 57% for the three groups. CONCLUSION: Doctors, nurses and medical students were inconsistent, inaccurate and imprecise in their prediction of LE with a tendency toward underestimation. This may lead to patients being managed inappropriately. There is a need for improved training and objective outcome prediction models.

The effect of Nd:YAG laser posterior capsulotomy on stereoacuity.

AIMS: To assess the effect of Nd:YAG laser posterior capsulotomy in the context of unilateral posterior capsular opacification (PCO) on spatial acuity, contrast sensitivity, and stereoacuity. METHODS: This prospective study involved 60 consecutive subjects with unilateral PCO. The aforementioned parameters of visual function were assessed immediately prior and 3 weeks subsequent to unilateral posterior capsulotomy. RESULTS: In eyes that underwent laser posterior capsulotomy, the median spatial acuity (log minimum angle of resolution (MAR)) improved from 0.34 (20/44) to 0.16 (20/29) (P=<0.001, Wilcoxon test), while the median contrast sensitivity improved from 22.4 to 35.5 dB (P=<0.001, Wilcoxon test) after posterior capsulotomy. Fellow eyes exhibited negligible change in these visual parameters. The median stereoacuity improved from 240 to 60 s of arc (P=<0.001, Wilcoxon test). CONCLUSION: In the context of unilateral opacification of the posterior capsule, Nd:YAG laser posterior capsulotomy affords significant improvement in stereoacuity, apparently in excess of improvements in spatial acuity and contrast sensitivity. Routine measurement and documentation of these parameters of visual function is recommended especially when subjective visual disability appears disproportionate with impairment of spatial acuity.

Detailed evaluation of functional recovery following laparoscopic or open surgery for colorectal cancer within an enhanced recovery programme.

BACKGROUND AND AIMS: Evidence demonstrating improved short-term outcomes with laparoscopic surgery compared with open surgery for colorectal cancer is accumulating. In addition, programmes optimising peri-operative care for major abdominal surgery are becoming widespread. Evaluating laparoscopic surgery and enhanced recovery programmes usually focuses on short-term recovery. The aim of this study was to compare recovery after laparoscopic and open surgery for colorectal cancer up to 1 year post-operatively, using a combination of self-report and observer data. PATIENTS/METHODS: From January 2002 to March 2004, 62 patients were randomised (2:1) to receive laparoscopic (n=43) or open surgery (n=19) within an enhanced recovery programme. Functional outcomes up to 1 year were assessed using interview-administered questionnaires. RESULTS/FINDINGS: Questionnaire and health-related quality of life data were obtained in over 85% of patients. Patients undergoing laparoscopic surgery felt fully recovered and resumed driving more quickly than those having open surgery (p=0.016 and p=0.048 respectively). Fifty-eight percent of patients having open surgery felt fully recovered by 12 months versus 88% of laparoscopic patients. INTERPRETATION/CONCLUSION: Within an enhanced recovery programme, patients undergoing laparoscopic surgery recovered more quickly than after open resection. Both approaches however, were associated with slow recovery despite a relatively short hospital stay.

To what extent does a lack of refrigeration of generic chloramphenicol eye-drops used in India decrease their purity and what are the implications for Europe?

BACKGROUND/AIMS: Thermal degradation of chloramphenicol occurs at a faster rate when stored in unrefrigerated conditions. This study measures the concentration of the principal thermal breakdown product of generic chloramphenicol eye-drops being sold over the counter in chemists in different locations in India. METHODS: Forty-eight samples of generic chloramphenicol eye-drops were collected form Delhi and Chennai (Madras) in India. Conditions of storage of chloramphenicol eye-drops were recorded at the time of purchase. Concentrations of a hydrolytic degradation product of chloramphenicol were measured using validated high-pressure liquid chromatography. Results were compared with accepted UK standards. RESULTS: Significantly higher levels of chloramphenicol thermal breakdown product were found in collected samples. All samples purchased were being stored in unrefrigerated conditions in the chemists sampled. Shelf lives exceeded UK equivalents, varying considerably between manufacturers. CONCLUSION: Inadequate refrigeration and prolonged shelf lives of chloramphenicol generics collected from Delhi and Chennai are associated with very high levels of chloramphenicol thermal breakdown product. These levels substantially exceed UK quality-assurance standards undermining product reliability, possibly contributing to the positive selection of resistant organisms and product toxicity effects. The principals of quality-assurance breakdown described are particularly relevant to Europe, following recent deregulation of chloramphenicol eye-drops purchased over the counter.

Analysis of consultant decision-making in the management of prostate cancer.

The purpose of this study was to assess the consistency of decision-making among consultant urologists in the management of early prostate cancer. Thirty-two UK urology consultants completed a questionnaire containing 70 paper scenarios representing patients with early prostate cancer. Within these were 13 repeat cases to allow assessment of reliability of decision-making. Consultants demonstrated low reliability (on average 56-79%) when formulating decisions. None of the consultants used all of the available patient information when formulating treatment plans. The cue 'patient choice' was not used significantly by any of the consultants and the cue 'patient co-morbidity' was rarely used despite being crucial components of decision-making. These results are surprising and in general represent poor clinical practice. They also justify the increasing use of the multidisciplinary team and protocol-driven pathways to standardize and thus improve patient care.

Factors affecting the surgical outcome of primary exotropia.

AIMS: To identify the predictors for motor outcome and response to surgical treatment of primary exotropia. SETTING: Taunton and Somerset Hospital, Somerset, United Kingdom. STUDY TYPE: Retrospective analysis of the surgical treatment of primary exotropia performed in our department over a period of 12 years from April 1991 to May 2003. METHODS: Case-notes of the patients who had surgical treatment for primary exotropia for the specified period were identified by a hospital computer database (MDI coding). All case-notes were reviewed and the following data were recorded and used for statistical analysis: age at the time of surgery, type and severity of exotropia, presence of amblyopia, AV pattern and vertical deviation, the level of stereopsis, type of surgery, and motor and cosmetic results. The surgical outcome was determined as good motor outcome if tropia was within 10 PD of orthotropia. The response to surgery was derived from the difference between the preoperative and postoperative angle of deviation for distance per amount of muscle surgery in millimetres. RESULTS: A total of 124 cases were included in the study. Good motor outcome was achieved in 83 (67%) cases. There was a positive correlation between the preoperative angle of deviation at distance and dose response to surgery (r = 0.6 and p < 0.001) and a negative correlation between average corrected visual acuity and response (r = -0.21 and p = 0.025). There was a statistically significant negative relationship between preoperative stereopsis and response to surgery (p = 0.02). CONCLUSIONS: Surgical treatment for exotropia is effective and the dose response is correlated to the preoperative angle of deviation and average visual acuity. Poor or no preoperative stereopsis was associated with better response to surgery.

Red cell damage after pumping by two infusion control devices (Arcomed VP 7000 and IVAC 572).

The aim of this study was to assess the performance in terms of red cell damage of two peristaltic volumetric infusion pumps - the Alaris IVAC 572 (San Diego, CA, USA) and Arcomed Volumed VP7000 (Regensdorf, Switzerland). Various infusion pumps are available to transfuse blood at a predetermined rate. It is recommended that each machine should be individually assessed. This experiment used six units of single-donor-transfusable packed red cells and ran each unit through both pumps. This was carried out at 9, 28 and 35 days post-donation at rates from 2 to 150 mL h(-1). Post-pumping samples from these experiments, and a pre-pumping sample in each case, were analysed for levels of potassium and free haemoglobin (Hb). They were also examined microscopically for evidence of cell damage. Potassium levels showed no significant change with pumping on any occasion, but rose significantly as the samples aged. Free Hb showed some variation, but the only consistent finding was a similar rise in value with increasing pack age. Microscopic examination revealed no cell damage under any condition. Both pumps performed to an acceptable level and appear safe to be used for red cell transfusion.

Early surgical outcomes in 5-year-old patients with repaired unilateral cleft lip and palate.

OBJECTIVE: To assess the surgical outcome of 5-year-old subjects with repaired unilateral cleft lip and palate who had been operated on by a single surgeon. DESIGN: Retrospective consecutive outcome study. SETTING: The cleft lip and palate center at Frenchay Hospital, North Bristol NHS Trust, U.K. PARTICIPANTS: All patients born with unilateral cleft lip and palate between May 1992 and April 1998 were identified and their study models were located. MAIN OUTCOME MEASURES: The reasons for failing to obtain study models were recorded. The "test" study models were combined randomly with a "gold standard" set of study models to give a group of 53 for assessment purposes. These study models were assessed twice by two examiners independently using the 5-Year-Olds' Index. The weighted kappa (kappa) statistic and components of variance were used to establish the levels of agreement within and between examiners, as well as between the gold standard and the examiners. RESULTS: Thirty sets of study models out of a possible 43 were located. The most common reason for not obtaining records was poor cooperation. More than 50% of study models were assessed as being good outcomes (Index groups 1 and 2), whereas fewer than 20% of the records were evaluated as being poor outcomes (Index groups 4 and 5). There was good inter- and intraexaminer agreement and agreement with the gold standard values. CONCLUSION: Study model collection in this age group can be difficult due to patient cooperation.

Probability of early pregnancy loss in women with vaginal bleeding and a singleton live fetus at ultrasound scan.

Bleeding is a common feature of early pregnancy affecting about one-fifth of pregnant women in the first trimester. The chance of miscarriage after bleeding and a live fetus at scan has not previously been defined precisely. The purpose of this study was to evaluate the outcome of early pregnancies with a viable singleton fetus that had been complicated by bleeding. A prospective study was performed on 370 women with a singleton live fetus who had presented to the early pregnancy assessment clinic (EPAC) with vaginal bleeding. Women were grouped into light, moderate and heavy loss according to the self-assessed degree of vaginal bleeding. The women were also categorised according to the presence or absence of an intrauterine haematoma. The overall spontaneous miscarriage rate in the study was 11.1%; almost 90% of pregnancies continued to viability. Women with moderate or heavy bleeding had more than twice the rate of miscarriage compared with those with light bleeding. A total of 14% of the women had an intrauterine haematoma and those women were 2.6 times more likely to miscarry than those without (23% vs 9%). This relationship appeared to hold true even after controlling for blood loss. The data presented can be used to guide women with a live fetus about the chance of miscarriage after an episode of vaginal bleeding. We propose that a large multi-centre study should be undertaken to define precisely the risk miscarriage for each gestational week according to a range of clinical and ultrasound characteristics.