Computerised record linkage: Compared with traditional patient follow-up methods in clinical trials and illustrated in a prospective epidemiological study

1995 ◽  
Vol 48 (12) ◽  
pp. 1441-1452 ◽  
Keyword(s):  
Clinical Trials ◽  
Epidemiological Study ◽  
Record Linkage ◽  
Prospective Epidemiological Study

Prospective epidemiological study on the beginning of varicose veins

Phlebologie ◽  
2009 ◽  
Vol 38 (01) ◽  
pp. 17-25 ◽  
Author(s):  
U. Schultz-Ehrenburg ◽  
S. Reich-Schupke ◽  
B. Robak-Pawelczyk ◽  
T. Rudolph ◽  
C. Moll ◽  
...  
Keyword(s):  
Epidemiological Study ◽  
Varicose Veins ◽  
Initial Study ◽  
Longitudinal Vein ◽  
Saphenous Veins ◽  
Prospective Epidemiological Study ◽  
Study Population

Summary Objective: To conduct a longitudinal vein study in a young study population on when and how varicose veins develop in healthy veins. Population, method: The initial study population consisting of pupils aged 10–12 (BO I, n = 740) underwent clinical and ultrasound follow-up at the ages of 14–16 (BO II, n = 518), 18–20 (BO III, n = 459) and 29–31 (BO IV, n = 136). During BO I-IV all venous findings detected (including preclinical refluxes of the saphenous veins) were recorded. Results: The data were broken down to reveal the incidence and prevalence of venous refluxes (VR), varicose veins (VV) and venous abnormalities (VA) for each part of the study. Furthermore, the data were analyzed longitudinally to identify any correlations between VR and VV in the two saphenous veins. Conclusions: Since none of the study subjects exhibited VV during BO I, the study permits evaluation of the venous situation in the subjects from birth on. The manifestation of a truncal VV is preceded by a VR in the same vein (p = 0.039). VR occurred mainly during puberty (BO I: 2.5%, BO III: 18.5%, BO IV: 25%). A preclinical VR represents a 30% risk (95% CI: 13–53%) of developing a truncal VV within four years, as a consequence, subsequent preventive 2-year follow-up examinations are recommended.

Identification of Patients at High Risk of Cancer after Venous Thromboembolic Disease: A Prospective Multicenter Observational Study

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 589-589
Author(s):  
Gilles Pernod ◽  
anne-Cecile Arnoult ◽  
Celine Genty ◽  
jean Philippe Galanaud ◽  
Marc Colonna ◽  
...  
Keyword(s):  
High Risk ◽  
Epidemiological Study ◽  
Risk Score ◽  
Social Consequences ◽  
High Risk Population ◽  
Anticoagulant Treatment ◽  
Prospective Epidemiological Study ◽  
Probability Of Cancer ◽  
Risk Of Cancer

Abstract Introduction: Recent studies have shown lower rates of cancer (2 – 3%) following a single episode of venous thromboembolism (VTE) than previously described. The absence of any proven impact of early diagnosis has revived the debate about systematic screening for cancer in these patients. The aim of this study was to identify whether any sub-groups of patients were at excessive risk of cancer. Methods: Based on available data at baseline and during a 3 years longitudinal follow-up of the OPTIMEV cohort, a French multicenter prospective epidemiological study (N° NCT00670540), we performed a comparative prospective epidemiological study, whose main objective was to reassess the occurrence of cancer after an episode of VTE. We sought to determine whether among the VTE positive (VTE+) patients there was any sub-group of patients at greater risk of cancer and to define classification criteria that would allow them to be identified. Results: Among 1565 VTE+ patients, 2.7% and 4.7% developed cancer during the 1stand 3 years of follow-up respectively. The probability of cancer before 3 years was similar whether the DVT was proximal or distal. In contrast, the probability of cancer before 3 years depended on the number of sites affected by VTE, 4.2 % [3.1 - 5.6] for those who had presented with unilateral DVT without PE, and 8.5% [4.6 - 15.2] for those with bilateral DVT with or without PE. The probability also depended on whether the thrombosis was idiopathic 7.1% [5.1 - 9.9] vsa probability of 4.1% [3.1- 5.5] for those who had non-idiopathic DVT. The probability of cancer was also linked to whether or not the patient was on anticoagulant treatment at the time of VTE recurrence. This was 24.8 % [13.7 - 42.5] for those who had relapsed whilst on anticoagulant treatment, 13.1% [7.4 -22.5 ] for those who have relapsed when not on anticoagulants, compared with 4.0% [3.1 - 5.2] for those who did not relapse (p < 0.01). After adjustment, in VTE+ patients, there was a significantly higher adjusted HR for patients over 50 years of age (HR 11.1 [2.7 - 45.5] (p < 0.01), those with idiopathic VTE (HR 1.8 [1.1-2.8] (p = 0.02), bilateral DVT with or without PE (HR 1.9 [1.01 - 3.7] (p = 0.05), those who had a recurrence during follow-up whilst on anticoagulant treatment (HR 6.5 [3.2 - 13.4] (p<0.01) and for those with a recurrence when not on anticoagulant treatment (HR 3.5 [1.9 - 6.5] (p<0.01). For VTE+ patients over 50 (n = 1169), we sought to classify these patients according to their risk of cancer by weighting risk factors according to adjusted HR from the multivariate model. Three points were given for recurrence while on anticoagulants, one point for a recurrence when not on anticoagulant treatment, one point for cases of idiopathic VTE and one point for cases of bilateral DVT. According to the scoring, the probability of developing cancer during follow-up was depicted table 1. Discussion The utility of systematically screening for cancer during an episode of VTE is debatable. The issue of the cost of screening in relation to its benefit in terms of reducing mortality and the problem of the physical and psycho-social consequences caused by such screening are also increasingly questioned. Based on the lower incidence of cancer observed in this prospective cohort, it might be more accurate to focus further studies regarding cancer screening on high risk population. Conclusion: Bilateral DVT, idiopathic but especially recurrent VTE appear to be good criteria for selecting patients over 50 years of age for whom the issue of cancer testing should be posed. Table 1 Class Risk N (% of VTE+ patients) Probability of cancer at 3y Low risk (score 0) 597 (51%) 3.6% [2.4 – 5.6] Intermediate risk (score 1 – 2) 525 (45%) 9.1% [6.8 – 12.2] High risk (score ≥ 3) 47 (4%) 27.3% [15.6 – 45.1] Disclosures Bosson: Sanofi-Aventis: Research Funding.

Data Management in an Epidemiological Study : Experiences from the Iowa 500 Field Follow-up and Family Study

1980 ◽  
Vol 19 (01) ◽  
pp. 37-41
Author(s):  
R. F. Woolson ◽  
M. T. Tsuang ◽  
L. R. Urban
Keyword(s):  
Data Management ◽  
Epidemiological Study ◽  
Family Study ◽  
Data Sets ◽  
Data Handling ◽  
Management Decisions ◽  
Numerous Data ◽  
Made In

We are now conducting a forty-year follow-up and family study of 200 schizophrenics, 325 manic-depressives and 160 surgical controls. This study began in 1973 and has continued to the present date. Numerous data handling and data management decisions were made in the course of collecting the data for the project. In this report some of the practical difficulties in the data handling and computer management of such large and bulky data sets are enumerated.

scholarly journals Real-World Experience with Bezlotoxumab for Prevention of Recurrence of Clostridioides difficile Infection

2020 ◽  
Vol 10 (1) ◽  
pp. 2
Author(s):  
Rosa Escudero-Sánchez ◽  
María Ruíz-Ruizgómez ◽  
Jorge Fernández-Fradejas ◽  
Sergio García Fernández ◽  
María Olmedo Samperio ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Real World ◽  
Recurrence Rates ◽  
Factors Associated ◽  
Clostridioides Difficile ◽  
Multicentre Cohort Study ◽  
Clostridioides Difficile Infection ◽  
Prevention Of Recurrence ◽  
Multicentre Cohort

Bezlotoxumab is marketed for the prevention of recurrent Clostridioides difficile infection (rCDI). Its high cost could be determining its prescription to a different population than that represented in clinical trials. The objective of the study was to verify the effectiveness and safety of bezlotoxumab in preventing rCDI and to investigate factors related to bezlotoxumab failure in the real world. A retrospective, multicentre cohort study of patients treated with bezlotoxumab in Spain was conducted. We compared the characteristics of cohort patients with those of patients treated with bezlotoxumab in the pivotal MODIFY trials. We assessed recurrence rates 12 weeks after completion of treatment against C. difficile, and we analysed the factors associated with bezlotoxumab failure. Ninety-one patients were included in the study. The cohort presented with more risk factors for rCDI than the patients included in the MODIFY trials. Thirteen (14.2%) developed rCDI at 12 weeks of follow-up, and rCDI rates were numerically higher in patients with two or more previous episodes (25%) than in those who had fewer than two previous episodes of C. difficile infection (CDI) (10.4%); p = 0.09. There were no adverse effects attributable to bezlotoxumab. Despite being used in a more compromised population than that represented in clinical trials, we confirm the effectiveness of bezlotoxumab for the prevention of rCDI.

scholarly journals Enrolling Incident Caregivers and Matched Controls From a Nationwide Epidemiological Study

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 658-658
Author(s):  
David Roth ◽  
William Haley ◽  
Orla Sheehan ◽  
J David Rhodes ◽  
Virginia Howard
Keyword(s):  
Blood Sample ◽  
Epidemiological Study ◽  
Racial Differences ◽  
Family Caregiving ◽  
Regards Study

Abstract Participants in the national Reasons for Geographic and Racial Differences in Stroke (REGARDS) study were asked about family caregiving responsibilities at enrollment (2003-2007). Among the 88% of participants who were not caregivers at enrollment, 1,229 reported becoming caregivers before a follow-up interview 12 years later. The Caregiving Transitions Study screened these participants and enrolled 251 as incident caregivers. All reported 5 or more hours of care per week, provided assistance with at least one ADL or IADL, and were caregivers for at least 3 months before a 2nd blood sample was obtained in the REGARDS study. A total of 251 noncaregiving control participants who reported no caregiving responsibilities over this 12-year period were also enrolled. Each control was matched to a caregiver on age (+ 5 years), sex, race, other demographics, and baseline (pre-caregiving) health variables. Descriptive analyses confirm the unique comparability of the samples compared to previous caregiving studies.

scholarly journals Disability improvement as a clinically relevant outcome in clinical trials of relapsing forms of multiple sclerosis

2021 ◽  
pp. 135245852110002
Author(s):  
Bruce AC Cree ◽  
Jeffrey A Cohen ◽  
Anthony T Reder ◽  
Davorka Tomic ◽  
Diego Silva ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Therapeutic Benefit ◽  
Disease Modifying Therapies ◽  
Long Term Follow Up ◽  
Post Hoc ◽  
Switch Group ◽  
Relevant Outcome

Background: Disease-modifying therapies (DMTs) can reduce the risk of disability worsening in patients with relapsing forms of multiple sclerosis (RMS). High-efficacy DMTs can lead to confirmed or sustained disability improvement (CDI and SDI). Objective and Methods: Post hoc analyses of data from the TRANSFORMS, FREEDOMS, and FREEDOMS II trials and their extensions assessed the effects of fingolimod (0.5–1.25 mg/day) on stabilizing or improving disability over ⩽8 years in participants with RMS. CDI and SDI rates were compared between participants initially randomized to fingolimod, interferon (IFNβ-1a), or placebo. Results: At 8 years’ follow-up in TRANSFORMS, 35.1% (95% confidence interval [CI], 28.2%–43.1%) of assessed participants in the IFNβ-1a–fingolimod switch group and 41.9% (36.6%–47.6%) on continuous fingolimod experienced CDI; disability did not worsen in approximately 70%. Similar results were seen in the combined FREEDOMS population. Proportionally fewer TRANSFORMS participants achieved SDI in the IFNβ-1a–fingolimod switch group than on continuous fingolimod (5.4% [3.0%–9.5%] vs 14.2% [10.8%–18.4%], p = 0.01). Conclusion: CDI and SDI are outcomes of interest for clinical trials and for long-term follow-up of participants with RMS. Monitoring CDI and SDI in addition to disability worsening may facilitate understanding of the therapeutic benefit of RMS treatments.

Patients with shoulder pain referred to specialist care; treatment, predictors of pain and disability, emotional distress, main symptoms and sick-leave: a cohort study with a six-months follow-up

2020 ◽  
Vol 20 (4) ◽  
pp. 775-783
Author(s):  
Kaia B. Engebretsen ◽  
Jens Ivar Brox ◽  
Niels Gunnar Juel
Keyword(s):  
Clinical Trials ◽  
Cohort Study ◽  
Sick Leave ◽  
Shoulder Pain ◽  
Emotional Distress ◽  
Outpatient Clinic ◽  
Treatment Duration ◽  
Specialist Care ◽  
Yellow Flags

AbstractObjectivesRecommendations for referral of patients with shoulder pain from primary to specialist care are mainly clinical. Several patients are referred without meeting these criteria for referral, whereas some are referred for a second opinion although surgery is not recommended. The aims of this study were to describe a shoulder pain cohort in specialist healthcare according to demographic data, clinical, and psychological factors; evaluate changes in pain and disability, distress and main symptoms from baseline to six-month follow-up; and to assess predictors of pain and disability, changes in the main symptoms and sick-leave at six-months. Results were compared to previous randomised trials conducted at the same clinic in patients with subacromial shoulder pain.MethodsThis prospective study included 167 patients from an outpatient clinic in specialist healthcare with shoulder pain for more than 6 weeks. Clinical (pain duration, intensity, pain sites), sociodemographic (age, gender, educational level, work status) and psychological variables (emotional distress (HSCL-10), fear of pain, screening of “yellow flags”, health-related quality of life) were collected. Shoulder pain and disability (SPADI-score) were assessed and the patients were asked about their outcome expectation and to predict their status of their shoulder problem the next month. They underwent a clinical interview, a clinical assessment of shoulder function and orthopaedic tests for diagnostic purposes. After six months they received a questionnaire with main variables.ResultsOf the 167 patients (55% women), 50% had symptoms for more than 12 months and 37 (22%) were on sick-leave. Characteristics were in general comparable to patients previously included in clinical trials at the same department. The SPADI-score was 46 (23) points. Mean emotional distress was within the normal range (1.7 (SD 0.6)). More than 80% had received treatment before, mainly physiotherapy in addition to the GPs treatment. One hundred and thirty-seven patients (82%) were re-referred to physiotherapy, 74 (44%) in the outpatient clinic specialist healthcare, and 63 (38%) in primary care. One hundred and eighteen (71%) answered the follow-up questionnaire. Mean change in SPADI-score was 10.5 points (95% CI (6.5–14.5)), and 29% of the patients improved more than the smallest detectable difference (SDD). The percentage sick-listed was 19.5%, and mean change in main symptoms (−9 to +9) was 3.4 (SD 3.9). The subgroup of patients receiving physiotherapy in outpatient specialist care did not show any significant change in the main variables. The prediction models suggested that a lower level of education, more fear of pain and a high baseline SPADI-score, predicted a higher SPADI-score at follow-up. A high baseline HSCL-10 score was the only significant predictor for a high HSCL-10 score. At follow-up, less pain at rest predicted more change in main symptoms and more yellow flags (a higher score on the Örebro screening test) predicted sick-leave.ConclusionsWithin the limitations of a cohort study, patients with persistent shoulder pain referred to an outpatient specialist clinic had similar baseline characteristics but shorter treatment duration, inferior clinical results and predictors somewhat different compared with previous clinical trials conducted at the same clinic. The study raises some questions about the effectiveness of the routines in daily clinical practice, the selection of patients, the treatment duration and content.

Sign in / Sign up

Export Citation Format

Share Document