Prospective randomised comparison of photocoagulation and rubber band ligation in treatment of haemorrhoids.

Two hundred and sixty eight patients with haemorrhoids were allocated at random to treatment by either photocoagulation (group 1, n=141) or rubber band ligation (group 2, n=127) and followed up for one year. There was no significant difference in the symptomatic outcome of treatment between the two groups at one, four, or 12 months, irrespective of whether first or second degree haemorrhoids were treated. Side effects of treatment (bleeding or severe pain) were significantly more common after rubber band ligation (n=11) than after photocoagulation (n=2; p less than 0.01). Further outpatient treatment, however, was required significantly more often after photocoagulation (n=23) than rubber band ligation (n=6) (p greater than 0.02), and 19 patients (14 in group 1 and five in group 2; NS) subsequently had a haemorrhoidectomy. At one year 26 of 103 patients were dissatisfied after photocoagulation compared with 20 of 88 after rubber band ligation. Photocoagulation is a safe and comfortable treatment which gives long term results that are as good as those of rubber band ligation. Complications are more common after rubber band ligation, but further treatment is required more commonly after photocoagulation.     

Adjuvant psychological therapy for patients with cancer: a prospective randomised trial.

OBJECTIVE--To determine the effect of adjuvant psychological therapy on the quality of life of patients with cancer. DESIGN--Prospective randomised controlled trial comparing the quality of life of patients receiving psychological therapy with that of patients receiving no therapy, measured before therapy, at eight weeks, and at four months of follow up. SETTING--CRC Psychological Medicine Group of Royal Marsden Hospital. PATIENTS--174 patients aged 18-74 attending hospital with a confirmed diagnosis of malignant disease, a life expectancy of at least 12 months, or scores on various measures of psychological morbidity above previously defined cut off points. INTERVENTION--Adjuvant psychological therapy, a brief, problem focused, cognitive-behavioural treatment programme specifically designed for the needs of individual cancer patients. MAIN OUTCOME MEASURES--Hospital anxiety and depression scale, mental adjustment to cancer scale, Rotterdam symptom checklist, psychosocial adjustment to illness scale. RESULTS--156 (90%) patients completed the eight week trial; follow up data at four months were obtained for 137 patients (79%). At eight weeks, patients receiving therapy had significantly higher scores than control patients on fighting spirit and significantly lower scores on helplessness, anxious preoccupation, and fatalism; anxiety; psychological symptoms; and on orientation towards health care. These differences indicated improvement in each case. At four months, patients receiving therapy had significantly lower scores than controls on anxiety; psychological symptoms; and psychological distress. Clinically, the proportion of severely anxious patients dropped from 46% at baseline to 20% at eight weeks and 20% at four months in the therapy group and from 48% to 41% and to 43% respectively among controls. The proportion of patients with depression was 40% at baseline, 13% at eight weeks, and 18% at four months in the therapy group and 30%, 29%, and 23% respectively in controls. CONCLUSIONS--Adjuvant psychological therapy produces significant improvement in various measures of psychological distress among cancer patients. The effect of therapy observed at eight weeks persists in some but not all measures at four month follow up.     

Improving medication compliance: a randomised clinical trial.

A medical monitor which recorded the date and hour each time a medicine bottle was opened was used to evaluate a programme for improving patients'' compliance with their treatment. Eighty-two patients with glaucoma who had been prescribed pilocarpine eye drops three times daily to prevent visual loss were randomised into two groups. Both groups used the medication monitor during two 20-day periods, but before the second period the experimental group were given an education and tailoring programme in an attempt to improve their compliance. Nine patients missed the second treatment period and were excluded from the analysis. The patients in the experimental group showed significantly improved compliance when compared with the control group. The numbers of missed doses were reduced by about half, as was the proportion of time that exceeded the eight-hour dose intervals. Follow-up studies are needed to determine how long the improved compliance persists, but anyone considering setting up an education and tailoring programme should recognise the extent to which therapeutic efforts are wasted because of non-compliance.     

Optimal timing of operation for bleeding peptic ulcer: prospective randomised trial.

From October 1980 to September 1983 all patients with upper gastrointestinal bleeding were admitted to a centralised unit and investigated by early endoscopy. A total of 142 patients with a proved duodenal or gastric ulcer were randomised after stratification for age and site of ulcer to early (aggressive) surgical management or a delayed (conservative) policy. Significantly more operations (n = 42; 60%) were performed in the early than in the delayed (n = 9; 20%) groups (p less than 0.01). There were no deaths among the 42 patients under 60. The overall mortality in the 100 patients aged over 60 was 10% and when analysed on an "intention to treat" basis there was no difference between early and delayed surgery. When, however, an unrelated death from a bleeding colonic polyp was excluded and the data analysed on "treatment received" the mortality was only 2% in the early group compared with 13% in the delayed group (p less than 0.05). When analysis was confined to gastric ulcer the difference between early (0%) and delayed (24%) treatment was even greater. The results of this trial indicate that for patients over 60 an aggressive surgical policy is associated with a significant reduction in mortality.     

Transurethral microwave treatment for benign prostatic hypertrophy: a randomised controlled clinical trial.

OBJECTIVES--To determine whether transurethral microwave treatment for patients with benign prostatic hypertrophy provides significant symptomatic relief, a reduction in residual urine volumes, and improvements in flow rates compared with sham treatment. DESIGN--Prospective double blind randomised study with follow up at three months. SETTING--Department of Urology in a London teaching hospital. PATIENTS--40 men completed the study: 22 received microwave treatment and 18 received sham treatment. Entry criteria were symptoms of prostatism of at least six months'' duration, a total symptom score > 14, and a peak urine flow rate < 15 ml/s or a residual urine volume > 50 ml. Exclusion criteria were prostatic cancer, a residual urine volume > 200 ml, a very large prostate, an obstructing middle lobe, acute urinary retention, impaired renal function, coexisting urinary tract disease, and previous prostatic surgery. INTERVENTIONS--A single 90 minute transurethral microwave treatment or sham treatment. OUTCOME MEASURES--Patients'' symptoms (including daytime frequency and nocturia) recorded in a self assessment symptom score questionnaire, peak urinary flow rates, and residual urine volumes. RESULTS--The mean total symptom scores of the patients who received microwave treatment fell from 30 to 11 compared with a fall from 31 to 26 for patients who received sham treatment (p < 0.001). Among patients who received microwave treatment daytime frequency fell from 9.4 to 5.5 voids a day and night time frequency from 3.5 to 1.6 voids a night; residual urine volumes fell from 104 ml to 52 ml; and peak urine flow rates increased by 2.3 ml/s. In the control group there was no improvement in any of these features. Treatment preserved sexual function and antegrade ejaculation. CONCLUSIONS--For selected patients with prostatism microwave treatment is effective and has few side effects.     

A prospective randomised controlled clinical trial comparing somatostatin and vasopressin in controlling acute variceal haemorrhage.

Twenty two patients were entered into a randomised controlled clinical trial comparing the efficacy of somatostatin and vasopressin in controlling acute variceal haemorrhage. Somatostatin was significantly more successful in controlling acute variceal haemorrhage than vasopressin (p = 0.003). Furthermore, no complications were observed during treatment with somatostatin.     

Prevention of respiratory complications after abdominal surgery: a randomised clinical trial.

OBJECTIVE--To evaluate the prevention of respiratory complications after abdominal surgery by a comparison of a global policy of incentive spirometry with a regimen consisting of deep breathing exercises for low risk patients and incentive spirometry plus physiotherapy for high risk patients. DESIGN--Stratified randomised trial. SETTING--General surgical service of an urban teaching hospital. PATIENTS--456 patients undergoing abdominal surgery. Patients less than 60 years of age with an American Society of Anesthesia classification of 1 were considered to be at low risk. OUTCOME MEASURES--Respiratory complications were defined as clinical features consistent with collapse or consolidation, a temperature above 38 degrees C, plus either confirmatory chest radiology or positive results on sputum microbiology. We also recorded the time that staff devoted to prophylactic respiratory therapy. RESULTS--There was good baseline equivalence between the groups. The incidence of respiratory complications was 15% (35/231) for patients in the incentive spirometry group and 12% (28/225) for patients in the mixed therapy group (P = 0.40; 95% confidence interval -3.6% to 9.0%). It required similar amounts of staff time to provide incentive spirometry and deep breathing exercises for low risk patients. The inclusion of physiotherapy for high risk patients, however, resulted in the utilisation of an extra 30 minutes of staff time per patient. CONCLUSIONS--When the use of resources is taken into account, the most efficient regimen of prophylaxis against respiratory complications after abdominal surgery is deep breathing exercises for low risk patients and incentive spirometry for high risk patients.     

Vitamin A supplements and mortality related to measles: a randomised clinical trial.

One hundred and eighty children admitted with measles were randomly allocated to receive routine treatment alone or with additional large doses of vitamin A (200,000 IU orally immediately and again the next day). Baseline characteristics of the two groups were virtually identical for age, severity of measles, and vitamin A and general nutritional states. In 91% of the children serum vitamin A concentrations were less than 0.56 mumol/l. Of the 88 subjects given vitamin A supplements, six (7%) died; of the 92 controls, 12 (13%) died (p = 0.13). This difference in mortality was most obvious for children aged under 2 years (one death out of 46 children receiving supplements versus seven deaths out of 42 controls; p less than 0.05) and for cases complicated by croup or laryngotracheobronchitis. Mortality was several times higher in marasmic than in better nourished children, regardless of study allocation (p less than 0.01).     

Falls and mobility in Parkinson's disease: protocol for a randomised controlled clinical trial

Background  

Although physical therapy and falls prevention education are argued to reduce falls and disability in people with idiopathic Parkinson's disease, this has not yet been confirmed with a large scale randomised controlled clinical trial. The study will investigate the effects on falls, mobility and quality of life of (i) movement strategy training combined with falls prevention education, (ii) progressive resistance strength training combined with falls prevention education, (iii) a generic life-skills social program (control group).     

Proximal gastric vagotomy versus long-term maintenance treatment with cimetidine for chronic duodenal ulcer: a prospective randomised trial.

Forty-four patients with chronic duodenal ulceration were allocated randomly to either long-term maintenance treatment with cimetidine or proximal gastric vagotomy. All were followed up both clinically and endoscopically for periods of one to four years. The rate of recurrence of ulcer during and after medical treatment was 54% while after surgery it was 10%. One patient developed severe allergic hepatitis while receiving maintenance treatment with cimetidine, and two others had to stop treatment because of possible drug reactions. Patients whose ulceration recurs while they are receiving treatment with cimetidine should be offered the possibility of operation.     

Chemotherapy in pancreatic cancer: results of a controlled,prospective, randomised,multicentre trial.

Forty patients with inoperable pancreatic cancer were included in a prospective, randomised, controlled trial of multiple chemotherapy. The survival of 19 untreated control patients was compared with that of 21 patients who received an initiation course of intravenous fluorouracil, cyclophosphamide, methotrexate, and vincristine given over five days followed by intravenous fluorouracil and mitomycin given over three or five days at six-week intervals thereafter. Median survival in treated patients was 44 weeks, which was significantly longer than the nine weeks seen in controls. In patients without metastases median survival was 48 weeks in the treated group and 12 weeks in controls. In patients with metastases it was 30 weeks in treated patients and seven weeks in controls. The treatment was well tolerated and seemed to confer a significant prolongation of survival, comparing favourably with previous reports of chemotherapy with or without radiotherapy. If the results are confirmed this regimen may be useful in district general hospital practice.     

The effectiveness of two smoking cessation programmes for use in general practice: a randomised clinical trial.

OBJECTIVE--To evaluate a structured, behavioural change, smoking cessation intervention designed for use within general practice. DESIGN--Randomised controlled clinical trial. SETTING--General practices in Newcastle, Australia. PATIENTS--311 Patients identified as smokers by a screening question were enrolled in the study. Of these, 101 were assigned to a structured behavioural change programme, 104 to a simple advice programme adapted from previous research, and 106 to a control group. No significant differences were found between groups for demographic and smoking related variables before the study. INTERVENTIONS--Patients in the simple advice group received a brief statement of advice from the general practitioner as well as three pamphlets; those in the structured intervention group were given strategies which included attitude and behavioural change programmes as well as techniques to aid compliance. The amount of smoking in all groups was assessed by self reports with validation by measurement of salivary cotinine concentrations. MAIN OUTCOME MEASURE--Significant increase in cessation rates. CONCLUSIONS--Significant differences between controls and the structured behavioural change group were found at the one month follow up, but only for self reported abstinence. The simple advice programme did not produce any significant differences over the control group. General practitioner evaluation of the structured programme highlighted difficulties in relation to the duration of the intervention. Overall the structured programme in its present form did not appear to be an effective programme for use within general practice.     

Pinch skin grafting or porcine dermis in venous ulcers: a randomised clinical trial.

Chronic venous ulcers are common, and even with effective compression or elevation large ulcers may take months to heal. Pinch skin grafting may allow healing from epithelial islands throughout the surface area of the ulcer, and a prospective randomised trial was therefore conducted comparing this treatment with porcine dermis dressings. Most patients were treated as outpatients, 25 ulcers being randomised to treatment with pinch skin grafts and 28 to treatment with porcine dermis. Though the groups were well matched, the mean healing rate in the first week was 15 cm2 for pinch skin grafts compared with 3.5 cm2 with porcine dermis (p less than 0.02). By life table analysis 64% of ulcers treated by pinch grafts were healed at six weeks and 74% by 12 weeks compared with 29% and 46% of ulcers, respectively, treated with porcine dermis dressings (chi2 = 4.1; p less than 0.05). All ulcers that failed to heal within 12 weeks included an area posterior to the medial malleolus, where local compression may have been inadequate. Pinch skin grafting improves the rate of healing in large venous ulcers and is a simple technique that may be performed as an outpatient procedure under local anaesthesia.     

Umbilical cord clamping and preterm infants: a randomised trial.

OBJECTIVE--To investigate the clinical effects of regulating umbilical cord clamping in preterm infants. DESIGN--A prospective randomised study. SETTING--The Queen Mother''s Hospital, Glasgow. SUBJECTS--36 vaginally delivered infants over 27 and under 33 weeks'' gestation. INTERVENTION--Holding the infant 20 cm below the introitus for 30 seconds before clamping the umbilical cord ("regulated" group, 17 patients), or conventional management ("random" group, 19 patients). MAIN OUTCOME MEASURES--Initial packed cell volume, peak serum bilirubin concentrations, red cell transfusion requirements, and respiratory impairment (assessed by ventilatory requirements, arterial-alveolar oxygen tension ratio over the first day in ventilated infants, and duration of dependence on supplemental oxygen). RESULTS--There were statistically significant differences between the two groups in mean initial packed cell volume (regulated group 0.564, random group 0.509) and median red cell transfusion requirements (regulated group zero, random group 23 ml/kg). 13 infants from each group underwent mechanical ventilation and showed significant differences in mean minimum arterial-alveolar oxygen tension ratio on the first day (regulated group 0.42, random group 0.22) and in median duration of dependence on supplemental oxygen (regulated group three days, random group 10 days). Differences in final outcome measures such as duration of supplemental oxygen dependence and red cell transfusion requirements were mediated primarily through arterial-alveolar oxygen tension ratio and also packed cell volume. CONCLUSIONS--This intervention at preterm deliveries produces clinical and economic benefits.     

Optimising informed consent for participants in a randomised controlled trial in rural Uganda: a comparative prospective cohort mixed-methods study

Background

Poor participant understanding of research information can be a problem in community interventional studies with rural African women, whose levels of illiteracy are high. This study aimed to improve the informed consent process for women living in rural eastern Uganda. We assessed the impact of alternative consent models on participants’ understanding of clinical trial information and their contribution to the informed consent process in rural Uganda.

Methods

The study applied a parallel mixed-methods design for a prospective comparative cohort, nested within a pilot study on the community distribution of an alcohol-based hand rub to prevent neonatal sepsis (BabyGel pilot trial). Women of at least 34 weeks’ pregnancy, suitable for inclusion in the BabyGel pilot trial, were recruited into this study from their homes in 13 villages in Mbale District. As part of the informed consent process, information about the trial was presented using one of three consent methods: standard researcher-read information, a slide show using illustrated text on a flip chart or a video showing the patient information being read as if by a newsreader in either English or the local language. In addition, all women received the patient information sheet in their preferred language. Each information-giving method was used in recruitment for 1 week. Two days after recruitment, women’s understanding of the clinical trial was evaluated using the modified Quality of Informed Consent (QuIC) tool. They were also shown the other two methods and their preference assessed using a 5-point Likert scale. Semi-structured interviews were administered to each participant. The interviews were audio-recorded, transcribed and translated verbatim, and thematically analysed.

Results

A total of 30 pregnant women in their homes participated in this study. Their recall of the trial information within the planned 48 h was assessed for the majority (90%, 27/30). For all three consent models, women demonstrated a high understanding of the study. There was no statistically significant difference between the slide-show message (mean 4.7; standard deviation, SD 0.47; range 4–5), video message (mean 4.9; SD 0.33; range 4–5) and standard method (mean 4.5; SD 0.53; range 4–5; all one-way ANOVA, p =?0.190). The slide-show message resulted in the most objective understanding of question items with the highest average QuIC score of 100 points. For women who had been recruited using any of the three models, the slide show was the most popular method, with a mean score for all items of not less than 4.2 (mean 4.8; SD 0.6; range 4–5). Most women (63%, 19/30) preferred the slide-show message, compared with 17% (5/30) and 20% (6/30) for the standard and video messages, respectively. The reasons given included the benefits of having pictures to aid understanding and the logical progression of the information.

Conclusion

Our results from this small study suggest that slide-show messages may be an effective and popular alternative way of presenting trial information to women in rural Uganda, many of whom have little or no literacy.

Trial registration

ISRCTN, ISRCTN67852437. Registered on 18 March 2018.

     

Patient ratings of chewing ability from a randomised crossover trial: lingualised vs. first premolar/canine-guided occlusion for complete dentures

Background: Complex procedures involving a facebow transfer and the use of lingualised teeth are deemed to have a positive influence on the chewing ability with complete dentures. Objectives: To determine if patients’ ratings of their ability to chew depend on the method of complete denture fabrication. Methods: Edentulous patients (n = 20) participated in a within‐subject crossover trial. Each patient received two sets of new complete dentures. One pair was manufactured based on intraoral tracing of centric relation and facebow transfer; semi‐anatomical teeth with lingualised occlusion denture (LOD) were chosen. The second pair was made using a simplified procedure without facebow transfer; jaw relations were recorded with wax occlusion rims, and anatomical teeth with a first premolar/canine‐guidance (CGD) were selected. The dentures were delivered in randomised order, and each was worn for 3 months. Three months after delivery, patients’ ratings of each new prosthesis were recorded on visual analogue scales for their ability to chew seven index foods. Repeated measurements analysis of variance was performed to investigate possible carry‐over effects accounting for confounding by treatment period. Results: When comparing the two treatments, participants rated their ability to chew in general, to masticate carrots, hard sausage, steak and raw apple in particular, was significantly better with the CGD (anatomical teeth) than with the LOD (p < 0.05). Conclusion: Comprehensive methods for the fabrication of complete dentures including semi‐anatomical lingualised teeth and a full registration do not seem to influence the perceived chewing ability, when compared with more simple procedures. Chewing ability for tough foods appears to benefit from the use of anatomical teeth.