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Selection criteria, methods of analysis and results presentation issues.

In this paper we presented materials and methods used for analysing survival of cancer patients recorded by the Italian cancer registries. First, we included first primary malignant tumours and excluded skin carcinomas, and cases identified by death certificate only, or by autopsy. Observed survival has been computed with the life-table method, with one month time lags. We corrected survival rates by the overall mortality effect (relative survival) with the Hakulinen method. The relative survival was age and sex adjusted with the EUROCARE method. Finally we discussed the results presentation issues.

Adolescent↗

[Long-term results of surgical treatment of stomach cancer: clinical experience of forty years from Sun Yat-sen University Cancer Center].

OBJECTIVE: To investigate the approaches to improve therapeutic effect of stomach cancer by analysis of the long-term results of surgical treatment of this disease. METHODS: Prognostic factors of stomach cancer were analyzed by Cox multivariate regression model based on clinical data of 2561 stomach cancer cases who underwent surgical treatment from 1964 to 2004 at Sun Yat-sen University Cancer Center. Survival rates were calculated by life table method. RESULTS: Gastrectomy was performed for 1950 cases with resectability of 76.1%, among which there were 1192 cases of curative resection (46.5%) and 758 cases of non-curative resection (29.6%). The other 611 cases of palliative operation included bypass procedures and laparotomy. Operative mortality of all cases was 0.8% and morbidity was 5.1%. For all cases the 1-, 3- and 5-year survival rate was 52.4%, 38.6% and 35.5%, respectively. The stage-specific 5-year survival rate was 86.8% (Stage I), 58.7% (Stage II), 28.4% (Stage III) and 7.6% (Stage IV), respectively. The 5-year survival after curative resection in the period of 40 years was 45.5%, and increased to 52.7% in the last two decades and 61.8% in recent decade. Stage-specific case proportion during the earlier two decades was 1.4% (Stage I), 10.6% (Stage II), 23.1% (Stage III) and 64.9% (Stage IV), respectively, and that during the recent two decades was 9.3%, 18.5%, 35.3% and 36.8%, respectively. The 5-year survival rate of cases during the earlier two decades was 18.0% and increased to 37.5% during the recent two decades. Multivariate analysis indicated that main prognostic factors of stomach cancer included TNM staging, curative resection and multidisciplinary treatment. CONCLUSIONS: Early detection and curative resection were the most important measures to improve therapeutic effect of stomach cancer. A surgery-predominant multidisciplinary treatment individualizing biological characteristics of tumor, staging of disease and tumor site will contribute to improvement of therapeutic effect of stomach cancer.

Adolescent↗

Effects of enamel-bonding, type of restoration, patient age and operator on the longevity of an anterior composite resin.

This study examined the survival of an anterior composite resin placed with or without enamel acid-etching using a low viscosity enamel bonding resin, for periods of approximately 16 years. The 950 conventional composite resin restorations were placed by numerous students and dentists for patients attending a dental hospital. Restorative failures were assessed using the life table method and specifically evaluated the placement method, type of restoration, patient age, and the dentist. There were no significant statistical differences between the two placement methods, or the two university and hospital dentist groups. However, there were significantly more failures with the Class IV restorations and in the oldest patient group. The enamel acid-etching and an enamel bonding resin did not display an advantage over unetched cavity preparations. The median survival for both methods of composite resin placement was 8-9 years.

Acid Etching, Dental↗

Carotid-subclavian bypass for brachiocephalic occlusive disease. Choice of conduit and long-term follow-up.

BACKGROUND AND PURPOSE: Atherosclerotic disease of the proximal brachiocephalic circulation may produce disabling symptoms referable to cerebral or upper extremity hypoperfusion and embolization. Bypass of occlusive lesions can provide durable relief of symptoms with minimal complications. The ideal conduit for carotid-to-subclavian and subclavian-to-carotid bypass remains controversial, and it is not clear whether the outflow vessel influences patency and survival. METHODS: We performed a retrospective analysis of 60 consecutive carotid-to-subclavian and subclavian-to-carotid bypass procedures. Occlusive lesions were documented preoperatively by arteriography. Patency was determined during follow-up by ultrasound or duplex examination. Actuarial patency, symptom-free survival, and overall survival rates were calculated by the life-table method and analyzed by log-rank test. RESULTS: Arterial transposition demonstrated the highest long-term patency rate (100.0 +/- 0.0%). Polytetrafluoroethylene grafts demonstrated the highest bypass graft patency rate (95.2 +/- 4.6%), followed by Dacron grafts (83.9 +/- 10.5%) and saphenous vein grafts (64.8 +/- 16.5%). Symptom-free survival paralleled patency rates, but these differences did not achieve statistical significance. While there were no differences in patency or symptom-free survival by outflow vessel, the overall survival of patients with common carotid lesions was significantly lower than that of patients with subclavian lesions (62.7 +/- 12.8% versus 100.0 +/- 0.0%; P < .05). CONCLUSIONS: The outflow vessel does not affect long-term patency in carotid and subclavian bypass procedures; however, patients with common carotid disease demonstrate significantly poorer long-term survival. Transposition results in superior long-term patency, with a trend toward lower results for synthetic grafts and relatively poor results for autogenous vein grafts.

Adult↗

Poor long-term survival after acute myocardial infarction among patients on long-term dialysis.

BACKGROUND: Cardiovascular disease is common in patients on long-term dialysis, and it accounts for 44 percent of overall mortality in this group. We undertook a study to assess long-term survival after acute myocardial infarction among patients in the United States who were receiving long-term dialysis. METHODS: Patients on dialysis who were hospitalized during the period from 1977 to 1995 for a first myocardial infarction after the initiation of renal-replacement therapy were retrospectively identified from the U.S. Renal Data System data base. Overall mortality and mortality from cardiac causes (including all in-hospital deaths) were estimated by the life-table method. The effect of independent predictors on survival was examined in a Cox regression model with adjustment for existing illnesses. RESULTS: The overall mortality (+/-SE) after acute myocardial infarction among 34,189 patients on long-term dialysis was 59.3+/-0.3 percent at one year, 73.0+/-0.3 percent at two years, and 89.9+/-0.2 percent at five years. The mortality from cardiac causes was 40.8+/-0.3 percent at one year, 51.8+/-0.3 percent at two years, and 70.2+/-0.4 percent at five years. Patients who were older or had diabetes had higher mortality than patients without these characteristics. Adverse outcomes occurred even in patients who had acute myocardial infarction in 1990 through 1995. Also, the mortality rate after myocardial infarction was considerably higher for patients on long-term dialysis than for renal-transplant recipients. CONCLUSIONS: Patients on dialysis who have acute myocardial infarction have high mortality from cardiac causes and poor long-term survival.

Adult↗

Surgical treatment and prognosis of gastric cancer in 2,613 patients.

AIM: To analyze the factors influencing the prognosis of patients with gastric cancer after surgical treatment, in order to optimize the surgical procedures. METHODS: A retrospective study of 2 613 consecutive patients with gastric cancer was performed. Of these patients, 2,301 (88.1%) received operations; 196 explorative laparotomy (EL), 130 by-pass procedure (BPP), and 1 975 surgical resection of the tumors (891 palliative resection and 1 084 curative resection). The survival rate was calculated by the actuarial life table method, and the prognostic factors were evaluated using the Cox regression proportional hazard model. RESULTS: Of the patients, 2,450 (93.8%) were followed-up. The median survival period was 4.6 mo for patients without operation, 5.2 mo for EL, 6.4 mo for BPP, and 15.2 mo for palliative resection (P = 0.0001). Of the patients with surgical resection of the tumors, the overall 1, 3 and 5-year survival rates after were 82.7%, 46.3% and 31.1%, respectively, with the 5-year survival rate being 51.2% in patients with curative resection, and 7.8% for those with palliative resection. The 5-year survival rate was 32.5% for patients with total gastrectomy, and 28.3% for those with total gastrectomy plus resection of the adjacent organs. The factors that independently correlated with poor survival included advanced stage, upper third location, palliative resection, poor differentiation, type IV of Borrmann classification, tumor metastasis (N3), tumor invasion into the serosa and contiguous structure, proximal subtotal gastrectomy for upper third carcinoma and D1 lymphadenectomy after curative treatment. CONCLUSION: The primary lesion should be resected as long as the local condition permitted for stage III and IV tumors, in order to prolong the patients' survival and improve their quality of life after operation. Total gastrectomy is indicated for carcinomas in the cardia and fundus, and gastric cancer involving the adjacent organs without distant metastasis requires gastrectomy with resection of the involved organs.

Adenocarcinoma↗

Transurethral resection of the prostate among Medicare beneficiaries in the United States: time trends and outcomes. Prostate Patient Outcomes Research Team (PORT).

OBJECTIVES: The purpose of this study was to examine the epidemiology of transurethral resection of the prostate (TURP) and associated risks among Medicare beneficiaries during the period of 1984 to 1990. METHODS: Medicare hospital claims for a 20% national sample of Medicare beneficiaries were used to identify TURPs performed during the study period. All reported rates were adjusted to the composition of the 1990 Medicare population. Risks of mortality and reoperation were evaluated using life-table methods. RESULTS: The age-adjusted rate of TURP reached a peak in 1987 and declined thereafter. Similar trends were observed for all age groups. In 1990, the rates of TURP (including all indications) were approximately 25, 19, and 13 per 1000 for men over the age of 75, 70 to 74, and 65 to 69, respectively. The 30-day mortality following TURP for the treatment of benign prostatic hyperplasia (BPH) decreased from 1.20% in 1984 to 0.77% in 1990 (linear trend, p = 0.0001). The cumulative incidence of a second TURP among men with BPH has likewise decreased steadily over time; in this study, the average was 7.2% over 7 years (5.5% when the indication for the second TURP was restricted to BPH only). CONCLUSIONS: The rate of TURP has been declining since 1987, conceivably due to increasing availability of alternative treatments or changes in treatment preferences of patients and physicians. Over the same period, the outcomes following TURPs have improved, perhaps due to improved surgical care and changes in patient selection.

Age Factors↗

Continuation of long term treatment with hydroxychloroquine in systemic lupus erythematosus and rheumatoid arthritis.

BACKGROUND: Hydroxychloroquine is used for the treatment of rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Long term studies have shown a high rate of termination of hydroxychloroquine treatment in patients with RA. Although it has been shown that discontinuation of treatment with hydroxychloroquine is associated with exacerbation of SLE, long term maintenance rates of treatment with hydroxychloroquine in patients with SLE have not been investigated. METHODS: Hydroxychloroquine use in patients with RA and SLE in a group of patients in a single community rheumatology practice was studied. Information was drawn from a computer drug use database containing details of the beginning and end of treatment. Data were analysed using life table methods. RESULTS: Four hundred and three treatment episodes (366 patients with RA, 37 patients with SLE) were observed over eight years. In patients with RA, the cumulative probability of discontinuing treatment was 37% at 12 months and 54% at 24 months. In contrast, hydroxychloroquine treatment of patients with SLE continued over significantly longer periods of time (p < 0.001); the discontinuation probabilities at 12 and 24 months were 8 and 24% respectively. Treatment terminations were predominantly for inefficacy; terminations for toxicity were limited to the first 19 months of treatment. No ocular toxicity was observed. CONCLUSIONS: Treatment of patients with RA in a community rheumatology practice with hydroxychloroquine has a low probability of long term continuation, mostly because of inadequate control of disease manifestations rather than toxicity. In patients with SLE, treatment with hydroxychloroquine has a significantly higher probability of long term continuation.

Adult↗

Abnormalities of chromosome bands 15q13-15 in childhood acute lymphoblastic leukemia.

BACKGROUND: Recurring breakpoints in chromosome bands 15q13-15 occur infrequently in leukemia. To the authors' knowledge, the clinical significance of these breakpoints in childhood acute lymphoblastic leukemia (ALL) has not been previously investigated. METHODS: Centrally reviewed karyotypes of children with newly diagnosed ALL enrolled on Children's Cancer Group protocols from 1988 to 1995 formed the basis of the current report. Statistical analyses used chi-square tests for homogeneity of proportions, and outcome was analyzed using life table methods and associated statistics. RESULTS: Of 1946 cases with centrally reviewed and accepted cytogenetic analyses, 23 cases (1%) had breakpoints in chromosome bands 15q13-15. Most patients with 15q13-15 breakpoints had standard risk ALL, although breakpoints in 15q13-15 occurred more frequently in infants than in older children. The majority of these patients (16 patients; 70%) had balanced 15q13-15 rearrangements. Additional chromosomal abnormalities not involving 15q included abnormal 12p, abnormal 9p, Philadelphia chromosome, deletion 6q, and an 11q23 breakpoint. Thirteen (57%) 15q13-15 breakpoints occurred in pseudodiploid karyotypes; five (22%) were in hyperdiploid karyotypes with 47-50 chromosomes; two (9%) were in hyperdiploid karyotypes with > 50 chromosomes; and three (13%) were in hypodiploid karyotypes. Of the 23 patients with 15q13-15 breakpoints, 21 were survivors, 18 survived event-free for 2.2-9.3 years, and 3 were alive 1 to 3 years after a relapse at time of writing. CONCLUSIONS: The current study suggests that genes at 15q13-15 may be involved in the leukemogenesis of some cases of childhood ALL, but that with current intensive therapy such aberrations do not confer increased risk of treatment failure.

Cell Transformation, Neoplastic↗

Vocational rehabilitation of locomotive engineers with ischaemic heart disease.

BACKGROUND: There is resistance among railway companies and their occupational health services to rehabilitating locomotive engineers with ischaemic heart disease to their former driving work. AIM: To study the outcome of vocational rehabilitation for locomotive engineers with ischaemic heart disease. METHODS: In seven European countries, selected locomotive engineers with ischaemic heart disease were compared to a matched group of healthy engineers. At the end of each calendar year between 1990 and 1999, questionnaires were completed by local occupational health physicians to provide information on accidents, incidents (professional mistakes), sick leave, (recurrent) cardiac events, death and early retirement. We used the life table method with five follow-up years to calculate the risk of accidents, incidents and recurrent cardiac events. RESULTS: The accident rate for the cardiac group was 3.8 accidents per 100 person-years, as compared to a rate of 6.0 in the reference group. The rates for incidents were 0.9 and 2.0, respectively. Neither of these differences were statistically significant. The duration of sick leave was significantly longer among the cardiac group than it was among the reference group, but only in the first follow-up year. Thirteen recurrent cardiac events occurred in the cardiac group, as compared to a single cardiac event in the reference group. There was no difference in the proportion of retirement cases. One engineer in each of the two groups died of cardiac disease. CONCLUSIONS: Locomotive engineers can safely resume driving duties following onset of cardiac disease.

Accidents↗

Endovascular management of isolated iliac artery aneurysms.

OBJECTIVE: We reviewed our experience with endovascular treatment of isolated iliac artery aneurysms (IAAs). METHODS: Medical records for consecutive patients undergoing endovascular IAA repair from 1995 to 2004 were reviewed. Computed tomography (CT) angiograms were used to assess IAA location, size, and presence of endoleaks after endovascular repair. Rates of primary patency and freedom from secondary interventions were estimated using the Kaplan-Meier life-table method. RESULTS: From July 1995 to November 2004, 45 patients (42 men), with a mean age of 75 years, underwent endovascular repair of 61 isolated IAAs: 41 common iliac, 19 internal iliac, and one external iliac. Five patients (11%) were symptomatic, although none presented with acute rupture. The mean preoperative IAA diameter was 4.2 +/- 1.7 cm. Fifteen patients (33%) had prior open abdominal aortic aneurysm repair. Local or regional anesthesia was used in 28 cases (62%). Thirty-four patients (75%) were treated with unilateral iliac stent-grafts, eight (18%) with bifurcated aortic stent-grafts, and three (7%) with coil embolization alone. Perioperative major complications included one early graft thrombosis that eventually required conversion to open repair and one groin hematoma that required operative evacuation. On follow-up, late complications included one additional graft thrombosis and one late death after amputation. No late ruptures occurred after endovascular repair, with a mean follow-up of 22 months (range, 0 to 60 months). The mean postoperative length of stay was 1.3 +/- 1.0 days. On postoperative CT scans obtained at 1, 6, 12, 24, and 36 months, aneurysm shrinkage was noted in 18%, 29%, 57%, 67%, and 83% of IAAs, respectively, compared with the baseline diameter. One hypogastric aneurysm enlarged in the presence of a later identified type II endoleak. Five endoleaks were noted (4 type II, 1 indeterminate) at 1 month, with four other endoleaks (1 type II, 1 type III, 2 indeterminate) identified on later CT scans. At 2 years, primary patency was 95%, and freedom from secondary interventions was 88%. CONCLUSIONS: Endovascular repair of isolated IAAs appears safe and effective, with initial results similar to those after endovascular abdominal aortic aneurysm repair.

Aged↗

[Retrospective study of the one-year patency of a cuffed polytetrafluoroethylene Venaflo-type graft placed for venous hemodialysis access].

PURPOSE: The objective of this study was to determine retrospectively the one year patency of a new polytetrafluoroethylene (ePTFE) graft with a cuff at the graft-vein anastomosis (Venaflo, Bard industries) placed for hemodialysis access. METHODS: From April first 1999 to December thirty first 2001, 37 consecutive patients (56.8 medium age) underwent 39 Venaflo graft for hemodialysis in Vascular Surgery Section from Bordeaux University Hospital. All medical files have been reviewed at the end of the first year following the operation, by consultation or phone call from the referent nephrologist. Six patients deceased with a functional graft before the end of the study. The patency outcomes were calculated with Kaplan Meier life table method. RESULTS: The one year primary patency is 60.03% with a 95% confident interval [43%; 77%] and secondary patency is 83.73% [70%; 96%]. CONCLUSION: The patency of cuffed ePTFE grafts for hemodialysis was satisfactory in comparison with the result of classic ePTFE grafts in the medical literacy. A large prospective multicentric medium term study would be necessary in order to confirm or not these results.

Aneurysm, False↗

Long-term outcome of dialysis patients in the United States with coronary revascularization procedures.

BACKGROUND: The optimal method of coronary revascularization in dialysis patients is controversial, as previous small retrospective studies have reported increased cardiac events after percutaneous transluminal coronary angioplasty (PTCA) compared with coronary artery bypass (CAB) surgery. The purpose of this study was to compare the long-term survival of chronic dialysis patients in the United States following PTCA or CAB surgery. METHODS: Dialysis patients hospitalized from 1978 to 1995 for first coronary revascularization procedure after initiation of renal replacement therapy were retrospectively identified from the United States Renal Data System database. Survival for the endpoints of all-cause death, cardiac death, myocardial infarction, and cardiac death or myocardial infarction was estimated by the life-table method and was compared by the log-rank test. The impact of independent predictors on survival was examined in a Cox regression model with comorbidity adjustment. RESULTS: The in-hospital mortality was 5.4% for 6887 PTCA patients and 12.5% for 7419 CAB patients. The two-year event-free survival (+/-SE) of PTCA patients was 52.9 +/- 0.7% for all-cause death, 72.5 +/- 0.7% for cardiac death, and 62.0 +/- 0.7% for cardiac death or myocardial infarction. In CAB patients, the comparable survivals were 56.9 +/- 0.6, 75.8 +/- 0.6, and 71.3 +/- 0. 6%, respectively (P < 0.02 for PTCA vs. CAB surgery for all endpoints). After comorbidity adjustment, the relative risk of CAB surgery (vs. PTCA) performed 1990 to 1995 for all-cause death was 0. 91 (95% CI, 0.86 to 0.97); cardiac death, 0.85 (95% CI, 0.78 to 0. 92); myocardial infarction, 0.37 (95% CI, 0.32 to 0.43); and cardiac death or myocardial infarction 0.69 (95% CI, 0.64 to 0.74). CONCLUSIONS: In this retrospective study, dialysis patients in the United States had better survival after CAB surgery compared with PTCA, but our study does not exclude the possibility of more unfavorable coronary anatomy in the PTCA patients at baseline. Our data support the need for prospective trials of newer percutaneous coronary revascularization procedures in dialysis patients.

Adult↗

Recurrent thoracic outlet syndrome.

Recurrent symptoms develop in 15% to 20% of patients undergoing either first rib resection or scalenectomy for thoracic outlet syndrome. Over the past 22 years 134 operations for recurrence were performed in 97 patients. Four operations were used: transaxillary first rib resection (26); supraclavicular first rib resection with neurolysis (15); scalenectomy with neurolysis (58); and brachial plexus neurolysis (35). Complications included temporary plexus injury (0.7%), temporary phrenic palsy (3.7%), and permanent phrenic palsy (1.4%). The combined primary success rate of all four operations for recurrence was 84% in the first 3 months. This fell to 59% at 1 to 2 years; 50% at 3 to 5 years; and 41% at 10 to 15 years. No significant difference was found in results between the four operations used for recurrence. When recurrence was caused by trauma the results of reoperations were better than when recurrence was spontaneous. The primary success rates of three initial operations for thoracic outlet syndrome were compared to their secondary success rates (improved after reoperation). By use of life-table methods, reoperation improved the 5- to 10-year success rate of transaxillary first rib resection from 69% to 86% and for scalenectomy from 69% to 84%. Reoperation is successful in most cases of recurrent thoracic outlet syndrome and better when recurrence is the result of a neck injury.

Adolescent↗

Artificial insemination with fresh donor semen.

One hundred and thirty-four patients received artificial insemination with fresh donor semen (AID). Using the life-table method of analysis, 72 pregnancies occurred, yielding a crude conception rate of 53.7%. The 134 women received an average of three inseminations per cycle for a total of 1,282 inseminations near the day of ovulation. The majority of pregnancies occurred by the seventh cycle. Forty-two pregnancies were achieved using a single donor; 30 pregnancies required changing the donor once, twice, or more. Among 42 patients who subsequently were treated with clomiphene citrate, 16 conceived. Two of these patients became pregnant after receiving hMG and hCG additionally. The life-table analysis of cumulative pregnancy rates following infertility therapy provides a relatively simple, powerful, and reliable tool for evaluating the effectiveness of therapy and its benefits. Patients should be advised that their chances of conception with AID approach that of normal fertile couples, provided that these patients persist in their treatment.

Adult↗

Long-term results of operation for 420 patients with early squamous cell esophageal carcinoma discovered by screening.

BACKGROUND: Cancer of the esophagus is one of the most commonly seen malignancies in China. From 1959 to 1981, mass screening of esophageal cancer disclosed that the age-adjusted incidence in the 40- to 69-year-old population in Lin County, Henan Province, was 470/10(5) In its northern part, an even higher incidence of 760/10(5)was found. As they were discovered by mass screening, most of them were found to have early lesions. Surgical treatment was done in attempt to find out the feasibility of managing esophageal carcinoma by early diagnosis and early treatment. This paper is the result of the long-term follow-up. METHODS: Since 1972, a total of 17 extensive mass screening has been conducted among more than 160,000 participants in the rural areas in Henan, Hebei, and northern Jiangsu provinces, sorting out more than 30,000 high-risk individuals. Among these individuals, 24,600 were examined by endoscopy, discovering 2,094 patients with carcinomas in the esophagus or gastric cardia; 757 of these 2,094 patients were found to have superficial esophageal cancer; 420 patients accepted surgical treatment. Esophagectomy with gastric replacement was performed through left thoracotomy in all patients. Cervical anastomosis 94 (22.4%), intrathoracic supraaortic anastomosis 307 (73.1%), and infra-aortic anastomosis 19 (4.5%) were done. Double thoracoabdominal lymphatic dissection was performed. RESULTS: The resection rate was 100%. One-month operative mortality occurred in 5 (1.2%). Postoperative complications developed and were satisfactorily treated in 28 patients (6.7%). Pathology of the cancer specimens showed that there were carcinoma in situ in 76 (all without lymphatic metastasis), intramucosal (TI) carcinoma in 126 (2 [1.6%] with lymphatic metastasis), and submucous infiltrating (TI) carcinoma in 218 (34 [15.6%] with lymphatic metastasis). All these 420 patients have been followed up to 2001 with a follow-up rate of 94.1%. Those who were lost to follow-up were taken as censored cases. The survival rates were calculated by the life-table method. The 5-, 10-, 15-, 20-, and 25-year survival rates were 86.14%, 75.03%, 64.48%, 56.17%, and 49.93%, respectively. CONCLUSIONS: Esophageal balloon cytology, endoscopy, mucosa 1.2% iodine stain, and multipoint biopsy may be the best approach for early diagnosis of esophageal carcinoma. Surgical resection of superficial esophageal cancer provides excellent long-term survival with acceptable quality of life. It was discovered that carcinoma in situ and intramucosal carcinoma gave far better results than the submucosal infiltrative carcinoma, as the latter tends to have a higher frequency of lymphatic metastasis.

Adult↗

Publications from multicentre clinical trials: statistical techniques and accessibility to the reader.

Articles from multicentre randomized clinical trials were analysed by methods adapted from Emerson and Colditz and Juzych et al. to compare the frequency with which different statistical methods are used by clinical trials investigators with the frequency used by other researchers, and to determine how much statistical knowledge is required to interpret the statistical treatment of data from clinical trials. We observed differences between the frequency of usage of statistical methods and the accessibility of the clinical trials publications and those of all medical research articles published by specific journals. Clinical trials publications are less accessible than others in medical journals to the reader who knows only descriptive statistics, t-tests, contingency tables, power calculations, and life table methods. Many more statistical methods must be known by a reader to understand fully publications regarding treatment group comparisons for the primary outcomes of interest from clinical trials.

Data Interpretation, Statistical↗

The prognostic value of exercise testing in patients with cystic fibrosis.

BACKGROUND: Previous studies have shown female sex, impaired pulmonary function, older age, malnutrition, and colonization of the respiratory tract with Pseudomonas cepacia to be associated with a poor prognosis in patients with cystic fibrosis. We sought to determine the prognostic value of exercise testing in addition to the other prognostic factors. METHODS: A total of 109 patients with cystic fibrosis, 7 to 35 years old, underwent pulmonary-function and exercise testing in the late 1970s. They were followed for eight years to determine the factors associated with subsequent mortality. Survival rates were calculated with standard life-table methods. Cox proportional-hazards regression models were used to determine crude relative risks of mortality and relative risks adjusted for age, sex, body-mass index, forced expiratory volume in one second (FEV1) end-tidal partial pressure of carbon dioxide (PCO2) at peak exercise, and oxygen consumption at peak exercise (VO2 peak). RESULTS: Patients with the highest levels of aerobic fitness (VO2 peak, > or = 82 percent of predicted) had a survival rate of 83 percent at eight years, as compared with rates of 51 percent and 28 percent for patients with middle (VO2 peak, 59 to 81 percent of predicted) and lowest (VO2 peak, < or = 58 percent of predicted) levels of fitness, respectively. After adjustment for other risk factors, patients with higher levels of aerobic fitness were more than three times as likely to survive than patients with lower levels of fitness. Colonization with P. cepacia was associated with a risk of dying that was increased fivefold. Age, sex, body-mass index, FEV1, and end-tidal PCO2 at peak exercise were not independently correlated with mortality. CONCLUSIONS: Higher levels of aerobic fitness in patients with cystic fibrosis are associated with a significantly lower risk of dying. Although better aerobic fitness may simply be a marker for less severe illness, measurement of VO2 peak appears to be valuable for predicting prognosis. Further research is warranted to determine whether improving aerobic fitness through exercise programs will result in a better prognosis.

Adolescent↗