Randomised controlled trial of follow up care in general practice of patients with myocardial infarction and angina: final results of the Southampton heart integrated care project (SHIP). The SHIP Collaborative Group. (17/17899)

OBJECTIVE: To assess the effectiveness of a programme to coordinate and support follow up care in general practice after a hospital diagnosis of myocardial infarction or angina. DESIGN: Randomised controlled trial; stratified random allocation of practices to intervention and control groups. SETTING: All 67 practices in Southampton and south west Hampshire, England. SUBJECTS: 597 adult patients (422 with myocardial infarction and 175 with a new diagnosis of angina) who were recruited during hospital admission or attendance at a chest pain clinic between April 1995 and September 1996. INTERVENTION: Programme to coordinate preventive care led by specialist liaison nurses which sought to improve communication between hospital and general practice and to encourage general practice nurses to provide structured follow up. MAIN OUTCOME MEASURES: Serum total cholesterol concentration, blood pressure, distance walked in 6 minutes, confirmed smoking cessation, and body mass index measured at 1 year follow up. RESULTS: Of 559 surviving patients at 1 year, 502 (90%) were followed up. There was no significant difference between the intervention and control groups in smoking (cotinine validated quit rate 19% v 20%), lipid concentrations (serum total cholesterol 5.80 v 5.93 mmol/l), blood pressure (diastolic pressure 84 v 85 mm Hg), or fitness (distance walked in 6 minutes 443 v 433 m). Body mass index was slightly lower in the intervention group (27.4 v 28.2; P=0.08). CONCLUSIONS: Although the programme was effective in promoting follow up in general practice, it did not improve health outcome. Simply coordinating and supporting existing NHS care is insufficient. Ischaemic heart disease is a chronic condition which requires the same systematic approach to secondary prevention applied in other chronic conditions such as diabetes mellitus.  (+info)

Study on propionyl-L-carnitine in chronic heart failure. (18/17899)

AIMS: In patients with chronic heart failure, fatigue is independent of haemodynamic and neuroendocrine changes and possibly may be due to impaired muscle metabolism. Propionyl-L-carnitine, a carnitine derivative, was shown in previous studies to improve muscle metabolism. The objective of this study was to evaluate the effect of propionyl-L-carnitine on exercise capacity in mild moderate chronic heart failure patients, treated with ACE inhibitors and diuretics. METHODS AND RESULTS: This was a phase III, double-blind, randomized, parallel, multicentre study. The primary objective was the evaluation of the effect of propionyl-L-carnitine vs placebo on maximum exercise duration using a bicycle exercise test. The primary analysis performed in the intention-to-treat population (271 and 266 patients in propionyl-L-carnitine and placebo), showed no statistically significant difference between treatments. A difference of 15 s in favour of propionyl-L-carnitine was observed in the completer/complier population (P=0.092). An a priori specified subgroup analysis on patients stratified by baseline maximum exercise duration showed a trend of improvement in propionyl-L-carnitine patients with shorter maximum exercise duration. A non a priori specified analysis in patients stratified by ejection fraction (< or = 30% vs 30-40%), showed a statistically significant difference in maximum exercise duration in favour of propionyl-L-carnitine in those patients with a higher ejection fraction (40 s, P<0.01). There were no safety issues. CONCLUSION: The study fails to meet the primary objective, but confirms the good safety profile of propionyl-L-carnitine. An exploratory non-prespecified analysis suggests that propionyl-L-carnitine improves exercise capacity in patients with preserved cardiac function. This hypothesis needs to be confirmed by a specific tailored study.  (+info)

Validation of a specific quality of life questionnaire for functional digestive disorders. (19/17899)

BACKGROUND: Dyspepsia and irritable bowel syndrome are suitable conditions for assessment of quality of life. Their similarities justify the elaboration of a single specific questionnaire for the two conditions. AIMS: To examine the process leading to the validation of the psychometric properties of the functional digestive disorders quality of life questionnaire (FDDQL). METHODS: Initially, the questionnaire was given to 154 patients, to assess its acceptability and reproducibility, analyse its content, and reduce the number of items. Its responsiveness was tested during two therapeutic trials which included 428 patients. The questionnaire has been translated into French, English, and German. The psychometric validation study was conducted in France, United Kingdom, and Germany by 187 practitioners. A total of 401 patients with dyspepsia or irritable bowel syndrome, defined by the Rome criteria, filled in the FDDQL and generic SF-36 questionnaires. RESULTS: The structure of the FDDQL scales was checked by factorial analysis. Its reliability was expressed by a Cronbach's alpha coefficient of 0.94. Assessment of its discriminant validity showed that the more severe the functional digestive disorders, the more impaired the quality of life (p<0.05). Concurrent validity was supported by the correlation found between the FDDQL and SF-36 questionnaire scales. The final version of the questionnaire contains 43 items belonging to eight domains. CONCLUSIONS: The properties of the FDDQL questionnaire, available in French, English, and German, make it appropriate for use in clinical trials designed to evaluate its responsiveness to treatment among patients with dyspepsia and irritable bowel syndrome.  (+info)

Reduced health-related quality of life among Hodgkin's disease survivors: a comparative study with general population norms. (20/17899)

BACKGROUND: Late complications after curative treatment of Hodgkin's disease are of special relevance because most of the cured are young adults. The aims of the present study were: (1) to compare health-related quality of life (HRQOL) in Hodgkin's disease (HD) survivors with normative data from the general Norwegian population and (2) to examine the relations between disease/treatment characteristics and HRQOL in the HD survivors. PATIENTS AND METHODS: 459 HD survivors aged 19-74 years (mean 44.0, SD 11.8) treated at the Norwegian Radium Hospital 1971-1991 were approached in 1994 and compared to norms from 2214 subjects approached in 1996. The norms are representative of the general Norwegian population. HRQOL was assessed by the Short Form 36 (SF-36), which measures HRQOL in eight separate scales (0 = worst health state, 100 = best health state). RESULTS: The HD survivors had lower scores than the normal controls on all scales after adjustment for age, gender and educational levels. Statistically significant differences (P < 0.01) were found in general health (10.4), physical functioning (6.1), role limitations (physical, 9.3), physical functioning (3.6) and in vitality (4.7). Patients with disease stage IB-IIB had the lowest scores on all scales. The differences in relation to stage/substage reached statistical significance (P < 0.01) in physical functioning and in role limitations (physical). Time since diagnosis, types of primary treatment or having relapsed were not associated with statistically significant differences in HRQOL. CONCLUSION: Long-term HD survivors have poorer HRQOL, primarily in physical health, than the general Norwegian population.  (+info)

Psychosocial impact of genetic testing in familial medullary-thyroid carcinoma: a multicentric pilot-evaluation. (21/17899)

BACKGROUND: Many crucial problems are associated with the diagnosis of inherited cancer susceptibility. One of the most important is related to the psychosocial consequences of the knowledge by the patients and their relatives of their own genetical status. Little data are available in the literature, mainly from studies including small numbers of selected and motivated patients. PATIENTS AND METHODS: From January till December 1997, we studied the psychometric and quality of life parameters of 77 subjects followed in two French specialized centers. These subjects had been treated for either sporadic or familial or were at risk for medullary thyroid carcinoma. All patients had previously attended genetic counselling with detection of germline Ret-mutations, were informed on their own genetic risk, had good short-term prognosis and performance status and did not receive recent cancer treatment. Each patient was invited to answer two questionnaires, the hospital anxiety and depression scale (HADS) and the subjective quality of life profile (SQLP). RESULTS: We report herein the descriptive results of this study (HADS and SQLP scores and distributions) and describe the individual clinical covariates that might explain the observed differences between subgroups of individuals. Although psychometric scores appeared similar in these subgroups, quality of life scores were lower in Ret-mutation carriers. Genetically-predisposed patients were less satisfied and expressed more expectations for favourable change in their quality of life. CONCLUSION: This finding suggests a high level of frustration and latent unsatisfaction related either to the management of the genetic information given by the clinicians and its psychosocial consequences or simply to the knowledge of the genetic risk of cancer. Further studies on the individual consequences of genetic testing, information delivery and when necessary psychotherapeutic interventions, are needed to insure the quality of presymptomatic genetic testing in this field of oncology.  (+info)

Improvement in quality of life measures after laparoscopic antireflux surgery. (22/17899)

OBJECTIVE: To determine if patients with gastroesophageal reflux "well controlled medically" had a different quality of life from those with residual symptoms receiving aggressive medical therapy, and to determine whether laparoscopic antireflux surgery significantly altered quality of life in patients with gastroesophageal reflux. SUMMARY BACKGROUND DATA: Clinical determinants of outcome may not adequately reflect the full impact of therapy. The medical outcomes study short form (SF-36) is a well-validated questionnaire that assays eight specific health concepts in three general fields. It may provide a more sensitive tool for judging the success of antireflux therapy. METHODS: A total of 345 patients undergoing laparoscopic antireflux surgery completed at least one questionnaire during the study period. Preoperative questionnaires were completed by 290 patients, 223 completed a questionnaire 6 weeks after surgery, and 50 completed the same questionnaire 1 year after surgery. A subgroup of 70 patients was divided before surgery into two groups on the basis of their response to standard medical therapy. RESULTS: Preoperative scores were extremely low. All eight SF-36 health categories improved significantly 6 weeks and 1 year after surgery. In the 70-patient subgroup, 53 patients (76%) underwent laparoscopic antireflux surgery because of symptoms refractory to medical therapy and 17 patients (24%) reported that their symptoms were well controlled but elected to have surgery because they wished to be medication-free. The preoperative quality of life scores of these two patient groups were equivalent in all but one category. Postoperative scores were significantly improved in all categories and indistinguishable between the two groups. CONCLUSIONS: Laparoscopic antireflux surgery is an effective therapy for patients with gastroesophageal reflux and may be more effective than medical therapy at improving quality of life.  (+info)

Atrioventricular nodal ablation and implantation of mode switching dual chamber pacemakers: effective treatment for drug refractory paroxysmal atrial fibrillation. (23/17899)

OBJECTIVE: To assess the effect of atrioventricular node ablation and implantation of a dual chamber, mode switching pacemaker on quality of life, exercise capacity, and left ventricular systolic function in patients with drug refractory paroxysmal atrial fibrillation. PATIENTS: 18 consecutive patients with drug refractory paroxysmal atrial fibrillation. METHODS: Quality of life was assessed before and after the procedure using the psychological general wellbeing index (PGWB), the McMaster health index (MHI), and a visual analogue scale for cardiac symptoms. Nine of the patients also underwent symptom limited exercise tests and echocardiography to assess left ventricular systolic function. RESULTS: The procedure allowed a reduction in antiarrhythmic drug treatment (p < 0.01). PGWB and symptom scores improved (p < 0.01) but the MHI score did not change. Left ventricular systolic function and exercise capacity were unchanged. CONCLUSIONS: Atrioventricular node ablation and implantation of a DDDR/MS pacemaker is effective treatment for refractory paroxysmal atrial fibrillation, producing improved quality of life while allowing a reduction in drug burden. The popularity of the treatment is justified, but further studies are needed to determine optimum timing of intervention.  (+info)

Quality of life in chronic heart failure: cilazapril and captopril versus placebo. Cilazapril-Captopril Multicentre Group. (24/17899)

OBJECTIVE: To measure quality of life (QOL) in patients with mild to moderate heart failure treated with angiotensin converting enzyme (ACE) inhibitors cilazapril or captopril. DESIGN: Randomised, double blind, placebo controlled, parallel groups trial. SUBJECTS: 367 patients with New York Heart Association (NYHA) heart failure class II (62%), III (36%) or IV (1%). METHODS: Patients were randomised to receive cilazapril 1 mg daily (n = 191) or captopril 25 mg three times daily (n = 90) for 24 weeks, or placebo for 12 weeks followed by cilazapril 1 mg daily for a further 12 weeks (n = 86). If patients had not responded after four weeks cilazapril was increased to 2.5 mg daily and captopril to 50 mg three times daily. QOL was assessed at baseline, 12, and 24 weeks using the sickness impact profile (SIP), the profile of mood states (POMS), the Mahler index of dyspnoea-fatigue, and a health status index (HSI). RESULTS: The physical dimension of the SIP averaged 7 units at baseline and improved after 12 weeks by 2.24 units in the cilazapril group, 2.38 units in the captopril group, and 1.51 units in the placebo group. The difference between drug and placebo was therefore 0.73 units (95% CI -0.86 to 2.32) for cilazapril, and 0.87 units (95% CI -0.96 to 2.70) for captopril, with small non-significant effect sizes (a statistical method for estimating the importance of a treatment related change) of 0.12 and 0.14. Similar results were observed for the total POMS and HSI scores. Although QOL improved more on the ACE inhibitors than on placebo, the effect sizes were not significant (< or = 0.26). CONCLUSIONS: Improvements in QOL in mild to moderate heart failure were small when treated with cilazapril or captopril compared with placebo.  (+info)