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Biomedical subjects

S Hollis

Publications and source records attributed to S Hollis.

At least 19 recordsLinked to original sources
PubMed1999

What is meant by intention to treat analysis? Survey of published randomised controlled trials.

OBJECTIVES: To assess the methodological quality of intention to treat analysis as reported in randomised controlled trials in four large medical journals. DESIGN: Survey of all reports of randomised controlled trials published in 1997 in the BMJ, Lancet, JAMA, and New England Journal of Medicine. MAIN OUTCOME MEASURES: Methods of dealing with deviations from random allocation and missing data. RESULTS: 119 (48%) of the reports mentioned intention to treat analysis. Of these, 12 excluded any patients who did not start the allocated intervention and three did not analyse all randomised subjects as allocated. Five reports explicitly stated that there were no deviations from random allocation. The remaining 99 reports seemed to analyse according to random allocation, but only 34 of these explicitly stated this. 89 (75%) trials had some missing data on the primary outcome variable. The methods used to deal with this were generally inadequate, potentially leading to a biased treatment effect. 29 (24%) trials had more than 10% of responses missing for the primary outcome, the methods of handling the missing responses were similar in this subset. CONCLUSIONS: The intention to treat approach is often inadequately described and inadequately applied. Authors should explicitly describe the handling of deviations from randomised allocation and missing responses and discuss the potential effect of any missing response. Readers should critically assess the validity of reported intention to treat analyses.

Data Collection↗
PubMed1999

A comparative study of the Podotrack, a simple semiquantitative plantar pressure measuring device, and the optical pedobarograph in the assessment of pressures under the diabetic foot.

AIMS: To test the Podotrack, a simple inexpensive semiquantitative footprint mat, for potential use as a screening tool for high plantar pressures, against the optical pedobarograph (a computerized device). METHODS: The Podotrack was superimposed on the pedobarograph for simultaneous measurement of pressures from both systems. Three independent observers quantified the pressures of Podotrack footprints from healthy controls and diabetic patients, both before (n=164) and after (n=183) training. The sensitivity of the Podotrack to identify high pressure areas measured by the pedobarograph (> 12.3 kg/cm2) was 78.7%, 45.8% and 44.3% (observer A, B and C) before training, but improved to 96.2%, 92.4% and 91.1% after training (P<0.01). Specificity for all three observers was more than 90% before and after training. Inter-observer agreement improved significantly after training (P<0.001). CONCLUSION: After a simple training of the observers, the Podotrack identified approximately all high pressure areas, suggesting that the Podotrack could be a useful screening tool to identify areas at risk of ulceration in diabetic patients. We recommend a standard training package for new Podotrack users, to optimize identification of diabetic patients at risk of foot ulceration.

Case-Control Studies↗
PubMed1999

Assessment of therapeutic response of oropharyngeal and esophageal candidiasis in AIDS with use of a new clinical scoring system: studies with D0870.

We developed and compared five scoring systems designed to quantitate therapeutic response in cases of oropharyngeal candidiasis. We utilized prospectively collected data on 114 patients treated with several doses of the azole D0870. Patients were infected with fluconazole-susceptible (n = 49) or -resistant organisms (MIC, > or = 16 mg/mL; n = 61). Patients with fluconazole resistance had lower CD4+ cell counts at baseline; more symptoms (P = .0006); a higher frequency of dysgeusia (P = .004), dysphagia (P = .006), and throat pain (P = .0034); and greater oral coverage by plaques of Candida. There was no difference between the two groups in terms of colony-forming units, and any change did not correlate with response to therapy. Resolution of dysphagia (P < .01) and oral pain (P < .01) correlated well with response to therapy, unlike retrosternal pain and throat pain, which were also less frequent. Xerostomia, a "furry" taste, and dysgeusia were frequent nonspecific symptoms. Scoring system C, weighting resolution of a symptom higher than absence of a symptom at baseline, yielded the best correlation with global outcome (r = 0.86) and allows the quantitation of incomplete but clinically beneficial responses to therapy.

AIDS-Related Opportunistic Infections↗
PubMed1999

Unexpected contribution of moderate traumatic brain injury to death after major trauma.

BACKGROUND: The cardiovascular reflex responses to injury and simple hemorrhage are coordinated in the central nervous system. Coincidental brain injury, which is present in 64% of trauma patients who die, could impair these homeostatic responses. The occurrence of hemorrhagic shock in the patient with head injury is also known to increase mortality. Therefore, there is a potential bidirectional interaction between traumatic brain injury and peripheral injury, which would result in an increased mortality when these two injuries coexist. Our objective was to test the hypothesis that moderate traumatic brain injury is an independent predictor of outcome in patients with multisystem trauma. METHODS: We carried out an analysis of the UK Trauma Audit and Research Network Database. Moderate traumatic brain injury was defined as an Abbreviated Injury Scale score of 3. The study population included 2,717 patients with multisystem injury: 378 patients had a moderate brain injury with peripheral injury, and 2,339 patients had extracranial injury alone. Mortality rates for both groups were compared at increasing injury severity. RESULTS: Moderate brain injury alone was associated with a mortality rate of 4.2%. However, when combined with extracranial injury, the risk of death was double that attributable to extracranial injury alone (odds ratio, 2.08; 95% confidence interval, 1.57-2.77). CONCLUSION: This study confirms that the coexistence of moderate traumatic brain injury with extracranial injury is associated with a doubling of the predicted mortality rate throughout the injury severity ranges studied.

Adolescent↗
PubMed1999

Ultrasound screening for hips at risk in developmental dysplasia. Is it worth it?

Between May 1992 and April 1997, there were 20,452 births in the Blackburn District. In the same period 1107 infants with hip 'at-risk' factors were screened prospectively by ultrasound. We recorded the presence of dislocation and dysplasia detected under the age of six months using Graf's alpha angle. Early dislocation was present in 36 hips (34 dislocatable and 2 irreducible). Of the 36 unstable hips, 30 (83%) were referred as being Ortolani-positive or unstable; 25 (69%) of these had at least one of the risk factors. Only 11 (31%) were identified from the 'at-risk' screening programme alone (0.54 per 1000 live births). Eight cases of 'late' dislocation presented after the age of six months (0.39 per 1000 live births). The overall rate of dislocation was 2.2 per 1000 live births. Only 31% of the dislocated hips belonged to a major 'at-risk' group. Statistical analysis confirmed that the risk factors had a relatively poor predictive value if used as a screening test for dislocation. In infants referred for doubtful clinical instability, one dislocation was detected for every 11 infants screened (95% confidence interval (CI) 8 to 17) whereas in infants referred because of the presence of any of the major 'at-risk' factors the rate was one in 75 (95% CI 42 to 149). Routine ultrasound screening of the 'at-risk' groups on their own is of little value in significantly reducing the rate of 'late' dislocation in DDH, but screening clinically unstable hips alone or associated with 'at-risk' factors has a high rate of detection.

Bone Diseases, Developmental↗
PubMed1999

The "distal-dorsal difference" as a possible predictor of secondary Raynaud's phenomenon.

OBJECTIVE: To investigate the possibility that a hand distal-dorsal difference in temperature of greater than 1 degree C (fingers colder than the dorsum) at a room temperature of 30 degrees C is a good predictor of secondary Raynaud's phenomenon (RP). METHODS: We imaged the hands of patients with primary Raynaud's phenomenon (PRP) and systemic sclerosis (SSc) using a thermal camera at room temperatures of 23 and 30 degrees C. From these images we measured the distal-dorsal difference in temperature for all fingers excluding the thumbs. At a room temperature of 23 degrees C we also performed a cold challenge test using water at 15 degrees C for 1 min and thermally imaged the rewarming process for 15 min. Several variables were derived from the rewarming curve. The procedure was repeated within 3 days to assess reproducibility. RESULTS: The best discriminator between PRP and SSc was found to be a distal-dorsal difference of > 1 degree C at 30 degrees C (p = 0.005). There is reasonable reproducibility when considering groups of patients. However, the intra-subject standard deviations were large, indicating that measurements for the same patient on separate visits may vary considerably. CONCLUSION: Our results suggest that the finding of a distal-dorsal difference of > 1 degree C (cold fingers) at 30 degrees C in a patient with RP is specific for underlying connective tissue disease.

Adolescent↗
PubMed1998

Does peripheral neuropathy invariably accompany nephropathy in type 1 diabetes mellitus?

In patients with Type 1 diabetes mellitus complicated by diabetic nephropathy and retinopathy, it is usually believed that significant neuropathy is almost universal, but few studies have directly addressed this. This study assessed neuropathy in 91 such subjects, using vibration perception thresholds (VPT) and the neuropathy disability score (NDS). A total of 34% of subjects had no neuropathy on age adjusted VPT (z score) and 26% had no neuropathy on NDS. The severity of neuropathy as measured by VPT z score was related to increasing glycated haemoglobin (P = 0.02) and male sex (P = 0.03), and NDS was independently associated with age (P < 0.0001) and HbA1c (P = 0.003). These factors together accounted for only 12 and 31% of the total variance in VPT z score and NDS, respectively. In conclusion, the study has shown that a significant proportion of patients with diabetic nephropathy are free of neuropathy, but the full explanation for their protection from neuropathy is unclear.

Adult↗
PubMed1998

Growth in renal failure: a longitudinal study of emotional and behavioural changes during trials of growth hormone treatment.

Growth and psychological functioning were studied in 30 patients with renal failure over a two year period following the offer of growth hormone treatment for significant short stature. Parents' concerns about growth decreased significantly during the study. Twenty eight parents (93%) accepted growth hormone treatment; most (74%) were satisfied with it and would opt for it again (89%). The views of these parents were unrelated to growth outcome in their child. This suggests that the positive responses were related more to the effort to improve growth than to any objective treatment success. In contrast children's reduction in concern about growth, satisfaction with treatment (36%), and decision to opt for growth hormone again (50%) were all significantly related to improvement in growth. Parents' reports of non-compliance increased significantly from 41% at 1 year to 91% at 2 years in the group as a whole. No significant changes were identified in maternal mental distress and no additional costs to the psychological health of the children seem to have resulted from the introduction of growth hormone treatment. A group of children was identified who accepted treatment but had continued poor growth. These appeared to be at particular risk of both physical problems and associated or consequent psychological difficulties.

Adolescent↗
PubMed1998

Well-being and treatment satisfaction in older people with diabetes.

OBJECTIVE: To measure well-being and treatment satisfaction and their correlates in older people with diabetes. RESEARCH DESIGN AND METHODS: A postal survey was conducted of 1,000 diabetic patients aged > or = 60 years, representing 56% of the resident older diabetic population in an inner-city health district with a largely indigenous population of 230,000 people and a widely varied socioeconomic mix. Well-being and treatment satisfaction were measured with diabetes-specific instruments and correlated with patient data held in a central register. RESULTS: There was an 81% response. The general well-being scores (median [interquartile range]) for patients on diet alone, tablets, and insulin were 54 (44-60), 53 (42-61), and 48 (35-56) (P < 0.001 comparing insulin with diet and tablets) compared with a scale maximum of 66. Treatment satisfaction scores were 35 (31-36), 35 (32-36), and 34 (30-36) (P < 0.001 comparing insulin with diet and tablets), scale maximum 36. Mean HbA1c concentrations were 5.0 +/- 1.4% (for patients on diet alone), 5.8 +/- 1.6% (tablets), and 6.6 +/- 1.7% (insulin) (P < 0.001 for each difference). Neither well-being nor treatment satisfaction correlated with HbA1c. Insulin-treated patients were younger and had been diabetic longer than non-insulin-treated patients; their well-being remained slightly, but significantly, lower when adjusted for age, sex, BMI, and diabetes duration, but treatment satisfaction was no longer significantly different. Women had lower well-being than men. CONCLUSIONS: It has proved possible to measure well-being and treatment satisfaction in a large community-based samples of older people with diabetes. At the level of glycemic control in this population, neither parameter correlated with HbA1c. The lower well-being in insulin-treated patients remained significant in multivariate analysis.

Aged↗
PubMed1997

Postural instability in diabetic neuropathic patients at risk of foot ulceration.

Diabetic peripheral neuropathy is believed to cause postural instability due to abnormal proprioception. We assessed body sway in four groups, each of 20 subjects, matched for age, sex, and BMI: non-diabetic controls, non-neuropathic diabetic controls, subjects with diabetic neuropathy and no history of foot ulceration, and subjects with diabetic neuropathy and a history of foot ulceration. Postural sway was assessed on a Kistler force plate using the Romberg test, measuring the standard deviation of the centre of pressure in both sagittal (antero-posterior movement) and frontal (side to side movement) planes with eyes open and closed. The Romberg test results were log transformed and then analysed using analysis of variance followed by Newman-Keuls test. There was no significant difference in body sway between the two control groups and the first group of subjects with diabetic neuropathy. However, in patients with a history of ulceration, values were significantly higher (p < 0.05) compared to all other groups in both planes and conditions studied. These results are suggestive of a relationship between impaired body sway control and foot ulceration. Postural instability may have clinical significance and increase the risk of minor trauma and ulceration in patients with diabetic neuropathy.

Analysis of Variance↗
PubMed1997

A randomised controlled trial of topical glycopyrrolate, the first specific treatment for diabetic gustatory sweating.

The treatment of gustatory sweating in diabetes mellitus is usually with oral anti-cholinergic drugs, but these frequently lead to unacceptable side effects. Glycopyrrolate is an anti-muscarinic agent that can be applied topically and is efficacious in gustatory sweating occurring in other conditions. In a double-blind placebo-controlled crossover study, we assessed the value of glycopyrrolate in 13 diabetic patients with gustatory sweating. Sweating was measured by a sweat challenge, and diaries recorded by the patients throughout the 2 weeks of each treatment period. Compared to placebo, glycopyrrolate reduced the sweat response to a challenge by 82% (p < 0.01). The frequency of episodes of gustatory sweating during the treatment period was also reduced by 51% (p < 0.01), with a nearly 100% reduction in the frequency of episodes of severe sweating (p < 0.01). In conclusion, topically applied glycopyrrolate is a very effective treatment in reducing both the severity and frequency of diabetic gustatory sweating.

Administration, Topical↗
PubMed1997

The behavioural response to whiplash injury.

We studied 50 consecutive patients presenting at an accident department after rear-end vehicle collisions and recorded symptoms and psychological test scores within one week of injury, at three months and at two years. The range of neck movement was noted at three months. Within one week of injury, psychological test scores were normal in 82% of the group but became abnormal in 81% of the patients with intrusive or disabling symptoms at over three months (p < 0.001) and remained abnormal in 69% at two years. The clinical outcome after two years could be predicted at three months with 76% accuracy by neck stiffness, 74% by psychological score and 82% by a combination of these variables. The severity of symptoms after a whiplash injury is related both to the physical restriction of neck movement and to psychological disorder. The latter becomes established within three months of the injury.

Accidents, Traffic↗
PubMed1997

The tactile circumferential discriminator. A new, simple screening device to identify diabetic patients at risk of foot ulceration.

OBJECTIVE: To evaluate the tactile circumferential discriminator (TCD) (Tacticon Medical Enterprises, West Chester, PA), a new, simple, handheld quantitative sensory testing device, in the identification of patients at potential risk of neuropathic ulceration. RESEARCH DESIGN AND METHODS: Patients with diabetes (n = 133) attending the Manchester Diabetes Centre or diabetic foot clinic seen within a 5-week period were assessed using the TCD, monofilaments, and vibration perception threshold (VPT) measured over the hallux. The sensitivity and specificity of each method in the identification of "high-risk" patients were compared. RESULTS: The TCD was easy to use, and there was a highly significant correlation between the results obtained compared with both filaments and VPT (P < 0.0001). Similarly, in the identification of patients at risk of ulceration, the TCD agreed with VPT in 75.2% of cases and with the monofilaments in 78.9%. In the identification of the 37 foot ulcer patients, TCD was highly sensitive (100%) but less specific (58.3%) than VPT (86.5%; 79.2%) and the monofilaments (91.9%; 76.0%). CONCLUSIONS: These data suggest that the TCD is a simple and reliable new technique for population screening for neuropathy and foot ulcer risk.

Adult↗
PubMed1997

Training for dental screening using clinical photographs.

OBJECTIVE: To determine how the referral pattern from school screening of a group of dentists changed following a training programme. DESIGN: Eighty clinical photographs of teeth were shown to a group of dentists both before and after a training programme. The photographs were of teeth in various stages of the carious process from children aged between three and 15 years. The dentists were shown each of the 80 photographs and were asked to categorise each slide according to the decision they were most likely to make during school screening. CLINICAL SETTING: An NHS Community Trust in Merseyside, UK. PARTICIPANTS: A group of 12 community dental officers. OUTCOME MEASURES: Evaluation was carried out in relation to consensus refer/not refer decisions. Consensus was defined as the majority decision provided that no more than two dentists disagreed with the majority. RESULTS: As a consequence of training there was a change from no consensus to consensus in 21.5 per cent of the slides, whereas only 2.5 per cent changed from consensus to no consensus. However, after training there was still no consensus on 30 per cent of the slides. CONCLUSIONS: This study demonstrates a means by which referral decisions from school screening can be audited.

Adolescent↗
PubMed1996

Reducing accident death rates in children and young adults: the contribution of hospital care. Steering Committee of the Major Trauma Outcome Study Group.

OBJECTIVE: To assess the contribution of trauma care to the recent decline in accident death rates among children and young people. DESIGN: Logistic regression modelling of temporal trends in the probability of death in patients admitted to hospital for the treatment of severe injury. SETTING: Hospitals participating the United Kingdom major trauma outcome study. SUBJECTS: 3230 patients with an injury severity score of 16 or more, who were admitted for more than three days, transferred or admitted to intensive care, or died from their injuries. MAIN OUTCOME MEASURES: Death or survival in hospital within three months of injury. RESULTS: Over the seven year period 1989-95 there was a substantial decline in the probability of death among children and young adults admitted to hospital after severe injury. The overall estimate of the reduction in the odds of death was 16% per year (odds ratio for the yearly trend 0.84; 95% confidence interval 0.79 to 0.89). This decline did not differ significantly between age groups. (0-4 years 0.79; 5-14 years 0.87; 15-24 years 0.83). CONCLUSIONS: Reductions in hospital case fatality have made an important contribution to reaching the Health of the Nation targets. The contribution of hospital care in the reduction of accident mortality should be taken into account in decisions about the allocation of resources to preventive and curative services.

Accidents↗
PubMed1996

The association between callus formation, high pressures and neuropathy in diabetic foot ulceration.

The presence of an ulcer beneath callus on the diabetic foot has been a well-documented and common clinical finding. We have conducted a prospective study to examine whether callus can be used to predict plantar intrinsic neuropathic diabetic foot ulcer formation. Sixty-three diabetic patients (43 male, 25 Type 1), median age 62 years (IQ range 52, 67), median diabetes duration 17 years (IQ range 8,25) participated in the study. All had neuropathy and peak plantar foot pressures (measured using a dynamic optical pedobarograph) > or = 10 kg cm-2. Calluses and previous ulcers were documented and classified. All ulcers occurring prior to and during the study were recorded, re-examination was 15.4 (range 10-22) months from baseline. Seven ulcers (6 patients) occurred during the study. Pressures were higher in the ulcer than non-ulcer sub-group (p = 0.04) with a relative risk of developing an ulcer of 4.7 for an area of elevated plantar pressure. This compares with a relative risk of 11.0 for an ulcer developing under an area of callus, and a relative risk of 56.8 for an ulcer developing on a site of previous ulceration. This study confirms that a history of previous ulceration is the highest risk factor for ulceration and demonstrates, for the first time, that the presence of plantar callus is highly predictive of subsequent ulceration. Careful history taking and examination of the foot to detect the presence of callus require no special training or equipment and callus should be recognized as a 'high risk' factor for foot ulceration.

Callosities↗
PubMed1996

Gustatory sweating in diabetes mellitus.

Gustatory sweating has been only rarely reported in diabetes mellitus and is thought to be due to axonal regeneration within the autonomic nervous system. We investigated the relationship of gustatory sweating to other diabetic complications. 196 patients in four groups (diabetic nephropathy, diabetic neuropathy, diabetic controls, and non-diabetic renal failure) were questioned about gustatory sweating. Somatic and autonomic neuropathy were assessed by clinical signs, vibration perception threshold, and heart rate variability. Sixty-nine percent of patients with nephropathy and 36% of those with neuropathy reported gustatory sweating, whereas less than 5% reported it in the other two groups. Five subjects reported that gustatory sweating either disappeared or significantly improved immediately after renal transplantation. Analysis of the nephropathy and neuropathy groups separately showed a strong correlation between gustatory sweating and degree of neuropathy (p < 0.01). This study shows that gustatory sweating is much more common than previously believed and demonstrates that it is often very closely linked with diabetic nephropathy.

Analysis of Variance↗