scholarly journals Routine educational outcome measures in health studies: Key Stage 1 in the ORACLE Children Study follow-up of randomised trial cohorts

2010 ◽  
Vol 96 (1) ◽  
pp. 25-29 ◽  
Author(s):  
D. R. Jones ◽  
K. Pike ◽  
S. Kenyon ◽  
L. Pike ◽  
B. Henderson ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Randomised Trial ◽  
Educational Outcome ◽  
Health Studies ◽  
Stage 1

scholarly journals Percutaneous laser disc decompression versus conventional microdiscectomy for patients with sciatica: Two-year results of a randomised controlled trial

2017 ◽  
Vol 23 (3) ◽  
pp. 313-324 ◽  
Author(s):  
Patrick A Brouwer ◽  
Ronald Brand ◽  
M Elske van den Akker-van Marle ◽  
Wilco CH Jacobs ◽  
Barry Schenk ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Disc Herniation ◽  
Randomised Trial ◽  
Prospective Trial ◽  
Leg Pain ◽  
Conventional Surgery ◽  
Laser Disc ◽  
Operation Rate ◽  
Significant Difference

Background Percutaneous laser disc decompression is a minimally invasive treatment, for lumbar disc herniation and might serve as an alternative to surgical management of sciatica. In a randomised trial with two-year follow-up we assessed the clinical effectiveness of percutaneous laser disc decompression compared to conventional surgery. Materials and methods This multicentre randomised prospective trial with a non-inferiority design, was carried out according to an intent-to-treat protocol with full institutional review board approval. One hundred and fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were randomly allocated to percutaneous laser disc decompression ( n = 55) or conventional surgery ( n = 57). The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analogue scores for back and leg pain and the patient's report of perceived recovery. Results The primary outcome measures showed no significant difference or clinically relevant difference between the two groups at two-year follow-up. The re-operation rate was 21% in the surgery group, which is relatively high, and with an even higher 52% in the percutaneous laser disc decompression group. Conclusion At two-year follow-up, a strategy of percutaneous laser disc decompression, followed by surgery if needed, resulted in non-inferior outcomes compared to a strategy of microdiscectomy. Although the rate of reoperation in the percutaneous laser disc decompression group was higher than expected, surgery could be avoided in 48% of those patients that were originally candidates for surgery. Percutaneous laser disc decompression, as a non-surgical method, could have a place in the treatment arsenal of sciatica caused by contained herniated discs.

Late events audit of sequential studies of seminoma after carboplatin.

2016 ◽  
Vol 34 (3_suppl) ◽  
pp. e281-e281
Author(s):  
Tim R. D. Oliver
Keyword(s):  
Cell Cancer ◽  
Single Agent ◽  
Randomised Trial ◽  
Standards Of Care ◽  
Testicular Germ Cell ◽  
Ethical Committee Approval ◽  
N 93 ◽  
Testicular Germ Cell Cancer ◽  
Stage 1

e281 Background: Seminoma is the least malignant subtype of testicular germ cell cancer and has the least risk of metastasis at presentation. Less established compared with its radio-sensitivity, is the fact that it is more chemo-sensitive than non-seminoma. Despite reporting single agent Platinum data in 1982 which supported this concept, most standards of care do not treat seminoma differently from non-seminoma. This abstract reviews personal series some with more than 30 years follow up primarily using email follow up with access to clinical support as required to support this concept. Methods: A total of 97 metastatic seminoma (20 cisplatin, 77 Carboplatin) treated 1980-2006, 167 Stage 1 cases receiving either 1 or two courses of adjuvant therapy treated 1985-2006 and 54 cases receiving chemotherapy as part of testis conservation (12 single agent Platinum and 42 BEP therapy) treated between 1978 and 2006. Prior to 1996 participation was through verbal informed consent and since this time ethical committee approval has been obtained for the ongoing studies. Results: A total of 11 relapses have occurred in patients in 5 studies of carboplatin monotherapy in 264 patients with various stages of seminoma. All have been salvaged by BEP as have 16 relapses after I course carboplatin in the MRC TE19 randomised trial No relapses have occurred after 24 months despite median of 96 months follow-up, 51(19%) > 20 years. Though late malignant and non-malignant events have occurred, the frequency in the cohort followed between 10 and 15 years (n = 93) is not in excess of age matched controls. Conclusions: While in primum non noce does not trump the Sword of Damocles, the lack of any problems to date provide justification for further prospective evaluation of this less toxic option in patient preference studies.

scholarly journals Health in overweight children: 2-year follow-up of Finnmark Activity School—a randomised trial

2014 ◽  
Vol 100 (5) ◽  
pp. 441-448 ◽  
Author(s):  
Ane Kokkvoll ◽  
Sameline Grimsgaard ◽  
Silje Steinsbekk ◽  
Trond Flægstad ◽  
Inger Njølstad
Keyword(s):  
Waist Circumference ◽  
Outcome Measures ◽  
Randomised Trial ◽  
Intervention Group ◽  
Family Intervention ◽  
Overweight Children ◽  
Single Family ◽  
Psychological Outcome ◽  
Pooled Data

ObjectiveTo compare a comprehensive lifestyle intervention for overweight children performed in groups of families with a conventional single-family treatment. Two-year follow-up data on anthropometric and psychological outcome are presented.DesignOverweight and obese children aged 6–12 years with body mass index (BMI) corresponding to ≥27.5 kg/m2 in adults were randomised to multiple-family (n=48) or single-family intervention (n=49) in a parallel design. Multiple-family intervention comprised an inpatient programme with other families and a multidisciplinary team, follow-up visits in their hometown, weekly physical activity and a family camp. Single-family intervention included counselling by paediatric nurse, paediatric consultant and nutritionist at the hospital and follow-up by a community public health nurse. Primary outcome measures were change in BMI kg/m2 and BMI SD score after 2 years.ResultsBMI increased by 1.29 kg/m2 in the multiple-family intervention compared with 2.02 kg/m2 in the single-family intervention (p=0.075). BMI SD score decreased by 0.20 units in the multiple-family group and 0.08 units in the single-family intervention group (p=0.046). A between-group difference of 2.4 cm in waist circumference (p=0.038) was detected. Pooled data from both treatment groups showed a significant decrease in BMI SD score of 0.14 units and a significant decrease in parent-reported and self-reported Strength and Difficulty Questionnaire total score of 1.9 units.ConclusionsTwo-year outcome showed no between-group difference in BMI. A small between-group effect in BMI SD score and waist circumference favouring multiple-family intervention was detected. Pooled data showed an overall improvement in psychological outcome measures and BMI SD score.Trial registration numberNCT00872807, http://www.clinicaltrials.gov.

scholarly journals Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? A feasibility randomised trial

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e046791
Author(s):  
Oghenekome Gbinigie ◽  
Julie Allen ◽  
Nicola Williams ◽  
Michael Moore ◽  
Alastair D Hay ◽  
...  
Keyword(s):  
General Practice ◽  
Urinary Tract ◽  
Outcome Measures ◽  
Randomised Trial ◽  
Antibiotic Use ◽  
Secondary Outcome ◽  
Uncomplicated Urinary Tract Infection ◽  
Tract Infections ◽  
Lost To Follow Up

ObjectivesTo determine the feasibility of conducting a randomised trial of the effectiveness of cranberry extract in reducing antibiotic use by women with symptoms of acute, uncomplicated urinary tract infection (UTI).DesignOpen-label feasibility randomised parallel group trial.SettingFour general practices in Oxfordshire.ParticipantsWomen aged 18 years and above presenting to general practice with symptoms of acute, uncomplicated UTI.InterventionsWomen were randomly assigned using Research Electronic Data Capture in a 1:1:1 ratio to: (1) immediate antibiotics alone (n=15); (2) immediate antibiotics and immediate cranberry capsules for up to 7 days (n=15); or (3) immediate cranberry capsules and delayed antibiotics for self-initiation in case of non-improvement or worsening of symptoms (n=16).Primary and secondary outcome measuresThe primary outcome measures were: rate of recruitment of participants; numbers lost to follow-up; proportion of electronic diaries completed by participants; and acceptability of the intervention and study procedures to participants and recruiters. Secondary outcomes included an exploration of differences in symptom burden and antibiotic use between groups.ResultsFour general practitioner practices (100%) were opened and recruited participants between 1 July and 2 December 2019, with nine study participants recruited per month on average. 68.7% (46/67) of eligible participants were randomised (target 45) with a mean age of 48.4 years (SD 19.9, range 18–81). 89.1% (41/46) of diaries contained some participant entered data and 69.6% (32/46) were fully complete. Three participants (6.5%) were lost to follow-up and two (4.4%) withdrew. Of women randomly assigned to take antibiotics alone (controls), one-third of respondents reported consuming cranberry products (33.3%, 4/12). There were no serious adverse events.ConclusionsIt appears feasible to conduct a randomised trial of the use of cranberry extract in the treatment of acute, uncomplicated UTI in general practice.Trial registration numberISRCTN Registry (ID: 10399299).

Skeletal and Dental Correction and Stability Following LeFort I Advancement in Patients With Cleft Lip and Palate With Mild, Moderate, and Severe Maxillary Hypoplasia

2021 ◽  
pp. 105566562199610
Author(s):  
Buddhathida Wangsrimongkol ◽  
Roberto L. Flores ◽  
David A. Staffenberg ◽  
Eduardo D. Rodriguez ◽  
Pradip. R. Shetye
Keyword(s):  
Retrospective Study ◽  
Outcome Measures ◽  
Cleft Lip ◽  
Outcome Measure ◽  
Cleft Lip And Palate ◽  
Inclusion Criteria ◽  
Maxillary Hypoplasia ◽  
Main Outcome Measure ◽  
Lateral Cephalograms

Objective: This study evaluates skeletal and dental outcomes of LeFort I advancement surgery in patients with cleft lip and palate (CLP) with varying degrees of maxillary skeletal hypoplasia. Design: Retrospective study. Method: Lateral cephalograms were digitized at preoperative (T1), immediately postoperative (T2), and 1-year follow-up (T3) and compared to untreated unaffected controls. Based on the severity of cleft maxillary hypoplasia, the sample was divided into 3 groups using Wits analysis: mild: ≤0 to ≥−5 mm; moderate: <−5 to >−10 mm; and severe: ≤−10 mm. Participants: Fifty-one patients with nonsyndromic CLP with hypoplastic maxilla who met inclusion criteria. Intervention: LeFort I advancement. Main Outcome Measure: Skeletal and dental stability post-LeFort I surgery at a 1-year follow-up. Results: At T2, LeFort I surgery produced an average correction of maxillary hypoplasia by 6.4 ± 0.6, 8.1 ± 0.4, and 10.7 ± 0.8 mm in the mild, moderate, and severe groups, respectively. There was a mean relapse of 1 to 1.5 mm observed in all groups. At T3, no statistically significant differences were observed between the surgical groups and controls at angle Sella, Nasion, A point (SNA), A point, Nasion, B point (ANB), and overjet outcome measures. Conclusions: LeFort I advancement produces a stable correction in mild, moderate, and severe skeletal maxillary hypoplasia. Overcorrection is recommended in all patients with CLP to compensate for the expected postsurgical skeletal relapse.

scholarly journals A longitudinal analysis of the progression from normal blood pressure to stage 2 hypertension: A 12-year Korean cohort

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eun Sun Yu ◽  
Kwan Hong ◽  
Byung Chul Chun
Keyword(s):  
Blood Pressure ◽  
Health Insurance ◽  
American Heart Association ◽  
American Heart ◽  
Heart Association ◽  
Normal Blood ◽  
Normal Blood Pressure ◽  
The Mean ◽  
Stage 1

Abstract Background The study aimed to estimate the incidence of and period of progression to stage 2 hypertension from normal blood pressure. Methods We selected a total of 21,172 normotensive individuals between 2003 and 2004 from the National Health Insurance Service-Health Screening and followed them up until 2015. The criteria for blood pressure were based on the American College of Cardiology/American Heart Association 2017 guideline (normal BP: SBP < 120 and DBP < 80 mmHg, elevated BP: SBP 120–129 and DBP < 80 mmHg, stage 1 hypertension: SBP 130–139 or DBP 80–89 mmHg, stage 2 hypertension: SBP ≥140 or DBP ≥ 90 mmHg). We classified the participants into four courses (Course A: normal BP → elevated BP → stage 1 hypertension→ stage 2 hypertension, Course B: normal BP → elevated BP → stage 2 hypertension, Course C: normal BP → stage 1 hypertension → stage 2 hypertension, Course D: normal BP → stage 2 hypertension) according to their progression from normal blood pressure to stage 2 hypertension. Results During the median 12.23 years of follow-up period, 52.8% (n= 11,168) and 23.6% (n=5004) of the participants had stage 1 and stage 2 hypertension, respectively. In particular, over 60 years old had a 2.8-fold higher incidence of stage 2 hypertension than 40–49 years old. After the follow-up period, 77.5% (n=3879) of participants with stage 2 hypertension were found to be course C (n= 2378) and D (n=1501). After the follow-up period, 77.5% (n=3879) of participants with stage 2 hypertension were found to be course C (n= 2378) and D (n=1501). The mean years of progression from normal blood pressure to stage 2 hypertension were 8.7±2.6 years (course A), 6.1±2.9 years (course B), 7.5±2.8 years (course C) and 3.2±2.0 years, respectively. Conclusions This study found that the incidence of hypertension is associated with the progression at each stage. We suggest that the strategies necessary to prevent progression to stage 2 hypertension need to be set differently for each target course.

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