A randomized controlled study of biochemical tests in primary care: interventions can reduce the number of tests but usage does not become more appropriate

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Serena Lillo ◽  
Trine Rennebod Larsen ◽  
Leif Pennerup ◽  
Kirsten Ohm Kyvik ◽  
Jens Søndergaard ◽  
...  
Keyword(s):  
Primary Care ◽  
Vitamin D ◽  
Controlled Study ◽  
Control Group ◽  
Test Results ◽  
Biochemical Tests ◽  
Primary Care Clinics ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Test Use

Abstract Objectives The use of laboratory tests increases worldwide, and to some extent their use is likely to be inappropriate. Although primary care is responsible for a substantial proportion of requests, this sector is less extensively investigated than hospitals. Methods We tested the effect of six combinations of four interventions applied to 313 primary care clinics, using vitamin D as model test (253,762 vitamin D results). We evaluated the changes in test numbers in the six intervention groups compared to the control group, and whether interventions resulted in more homogenous test use within groups or affected the distribution of test results. All interventions included information on vitamin D testing guidelines. Four groups were exposed to a non-interruptive alert in the ordering IT-system and in two groups this was supplemented by an interruptive alert. Half of the groups received monthly feedback reports. Results Application of alerts, irrespective of the combination with feedback reports, resulted in significantly reduced test numbers (maximum −46%). Guidelines either alone or combined with feedback reports did not cause significant difference from the control group. The within-group requesting pattern changed significantly for only two of the groups. The distribution of low and normal vitamin D results within groups showed no signs of more appropriate use of the test in any of the groups. Conclusions Some of the interventions reduced the number of tests, but there were no indications of improved adherence to the guidelines. The interventions may have led to under-utilization of the test and thus should be used with care.

Reflective testing – A randomized controlled trial in primary care patients

2020 ◽  
pp. 000456322096837
Author(s):  
Wytze P Oosterhuis ◽  
Wilhelmine PHG Verboeket-van de Venne ◽  
Cees TBM van Deursen ◽  
Henri EJH Stoffers ◽  
Bernadette AC van Acker ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
General Practitioners ◽  
Medical Records ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Test Results ◽  
Randomized Controlled ◽  
Primary Care Patients

Background Reflective testing, i.e. interpreting, commenting on and, if necessary, adding tests in order to aid the diagnostic process in a meaningful and efficient manner, is an extra service provided by laboratory medicine. However, there have been no prospective randomized controlled trials investigating the value of reflective testing in patient management. Methods In this trial, primary care patients were randomly allocated to an intervention group, where general practitioners received laboratory tests results as requested as well as add-on test results with interpretative comments where considered appropriate by the laboratory specialist, or to a control group, where general practitioners only received the laboratory test results requested. Patients’ medical records were evaluated with a follow-up period of six months. For both groups, the primary outcome measures, i.e. both intended action and actual management action, were blindly assessed by an independent expert panel as adequate, neutral or inadequate. Results In 226 of the 270 cases (84%), reflective testing was considered to be useful for the patient. In the intervention group ( n = 148), actual management by the general practitioner was scored as adequate ( n = 104; 70%), neutral ( n = 29; 20%) or not adequate ( n = 15; 10%). In the control group ( n = 122), these numbers were 57 (47%), 37 (30%) and 28 (23%). This difference was statistically significant ( P < 0.001). Conclusion This randomized controlled trial showed a positive effect of reflective testing in primary care patients on the adequacy of their management, as documented in medical records.

scholarly journals Evaluating a combined bowel preparation for small-bowel capsule endoscopy: a prospective randomized–controlled study

2019 ◽  
Vol 8 (1) ◽  
pp. 31-35 ◽  
Author(s):  
Stephanie L Hansel ◽  
Joseph A Murray ◽  
Jeffrey A Alexander ◽  
David H Bruining ◽  
Mark V Larson ◽  
...  
Keyword(s):  
Small Bowel ◽  
Capsule Endoscopy ◽  
Bowel Preparation ◽  
Diagnostic Yield ◽  
Completion Rate ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Background Capsule endoscopy (CE) is frequently hindered by intra-luminal debris. Our aim was to determine whether a combination bowel preparation would improve small-bowel visualization, diagnostic yield, and the completion rate of CE. Methods Single-blind, prospective randomized–controlled study of outpatients scheduled for CE. Bowel-preparation subjects ingested 2 L of polyethylene glycol solution the night prior to CE, 5 mL simethicone and 5 mg metoclopramide 20 minutes prior to CE and laid in the right lateral position 30 minutes after swallowing CE. Controls had no solid food after 7 p.m. the night prior to CE and no liquids 4 hours prior to CE. Participants completed a satisfaction survey. Capsule readers completed a small-bowel-visualization assessment. Results Fifty patients were prospectively enrolled (56% female) with a median age of 54.4 years and 44 completed the study (23 patients in the control group and 21 in the preparation group). There was no significant difference between groups on quartile-based small-bowel visualization (all P &gt; 0.05). There was no significant difference between groups in diagnostic yield (P = 0.69), mean gastric (P = 0.10) or small-bowel transit time (P = 0.89). The small-bowel completion rate was significantly higher in the preparation group (100% vs 78%; P = 0.02). Bowel-preparation subjects reported significantly more discomfort than controls (62% vs 17%; P = 0.01). Conclusions Combined bowel preparation did not improve small-bowel visualization but did significantly increase patient discomfort. The CE completion rate improved in the preparation group but the diagnostic yield was unaffected. Based on our findings, a bowel preparation prior to CE does not appear to improve CE performance and results in decreased patient satisfaction (ClinicalTrials.gov, No. NCT01243736).

scholarly journals Effects of a randomized controlled study on the behaviors of overweight schoolchildren

2021 ◽  
Vol 26 ◽  
Author(s):  
Anastácio Neco de Souza Filho ◽  
Thaynã Alves Bezerra ◽  
Paulo Felipe Ribeiro Bandeira ◽  
Luciana Gatto Azevedo Cabral ◽  
José Fernando Vila Nova de Moraes ◽  
...  
Keyword(s):  
Physical Activity ◽  
Behavioral Therapy ◽  
Vigorous Physical Activity ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Control Group ◽  
Daily Routine ◽  
Randomized Controlled ◽  
School Based ◽  
Significant Difference

This study aimed to determine the effects of a school-based multi-component intervention on accelerometer- measured physical activity (PA) and sedentary behavior (SB) in schoolchildren overweight. This is a randomized controlled study with overweight schoolchildren, allocated to experimental group (EG; n = 13; 7.6 ± 0.8 years; 42.9% boys) and control group (CG; n = 17; 8.2 ± 0.9 years; 26.7% boys). The EG was submitted to a 10-week school-based intervention, comprised of PA and psychological sessions (behavioral therapy), and nutritional guidance. The CG followed the daily routine of life. The time of PA and SB were measured using accelerometers used for seven days. To compare mean SB, moderate to vigorous physical activity (MVPA) and total physical activity (TPA), generalized estimation equations (GEE) were used. It was observed that the average time in MVPA and TPA increased significantly in EG at the weekend (+ 40.9 min / day, p < 0.001; and + 51.6 min/day, p = 0.035, respectively) and at full week (+ 62.9 min/day, p < 0.001; and + 225.0 9 min/day, p = 0.038, respectively). There was no significant difference in time spent in SB after the intervention in both groups. Thus, it was concluded that the proposed school-based multicomponent intervention was effective in increasing levels of MVPA and TPA in overweight schoolchildren. This finding can optimize future interventions to promote a healthy lifestyle for schoolchildren in the school environment.

scholarly journals Modulation of the human immune status by spinal thermal massage: a non-randomized controlled study

2021 ◽  
Keyword(s):  
Quality Of Life ◽  
Nk Cells ◽  
Nk Cell ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Experimental Group

Thermal and massage therapies have long been used to control pain. Although spinal thermal massage (STM) has been used worldwide, its effectiveness has not been proven in a controlled clinical study. We here conducted a non-randomized controlled trial to assess the pain-relieving and immunomodulatory effects of STM in old-aged patients experiencing pain or disability. The experimental group was treated with STM five times a week for 8 weeks and rehabilitative regular care (RRC). The control group was treated with only RRC. Pain and immunological parameters were tested before treatment and after 4 and 8 weeks of treatment. The scores of three pain parameters were lowered by STM, and the differences between the groups were statistically significant at the two time points (p < 0.01). Quality of life determined using the 3-level EuroQol five-dimensional questionnaire scores was significantly higher in patients in the experimental group than those in the control group. Effect sizes (ES) were in the range of medium to large in the pain-related measures (0.54–1.22). The total leukocyte counts and the proportions of lymphocytes and subsets were not significantly different between the groups, whereas the proportions of monocytes and natural killer (NK) cells were higher in the experimental group than in the control group after 8 weeks (p < 0.05). The production of interleukin (IL)-4 and interferon γ in T cells was not significantly different between the groups, whereas the production of IL-2 was high in the control group. However, there was a significant increase in IFN-γ production by NK cells in the experimental group (at 4 weeks, p < 0.05). ES were medium in the immunological measures (0.53–0.68). No significant difference was observed in the production of proinflammatory cytokines, IL-1β, tumor necrosis factor α, or IL-6 between the groups. In conclusion, STM treatment has a positive effect on subjective pain and quality of life. It also enhanced NK cell proportion and activity, suggesting that STM may be beneficial in the prevention of viral diseases and cancer in old-aged people.

scholarly journals Effect of Xiangbin Prescription in Gastrointestinal Function After Gynecological Abdominal Surgery: a Randomized Controlled Trial

2021 ◽  
Author(s):  
Yuyan Wu ◽  
Jinxuan Lin ◽  
Haiping Zeng ◽  
Yi Chen ◽  
Zhiqiang Chen ◽  
...  
Keyword(s):  
Postoperative Complications ◽  
Abdominal Surgery ◽  
Controlled Trial ◽  
Controlled Study ◽  
Chewing Gum ◽  
Control Group ◽  
Gastrointestinal Function ◽  
Blank Control Group ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Background: Recovery of gastrointestinal function after gynecological abdominal surgery is a major clinical problem. An effective intervention to promote the rapid recovery of gastrointestinal function postoperatively is lacking. This randomized trial investigated whether Xiangbin prescription (XBP) was feasible in terms of efficacy and safety on gastrointestinal function recovery in patients after gynecological abdominal surgery. Methods: A randomized controlled study was conducted, in which 190 patients with gynecological abdominal surgery who met the inclusion and exclusion criteria were enrolled. They were assigned randomly to XBP group, chewing gum group or blank control group, and respectively received the following treatments: took the XBP twice a day, chewed a piece of gum for about 15 minutes each 4 hours, or received conventional western basic treatment, starting on postoperative day 1 until defecation. Three groups were compared in terms of primary outcomes including the time of the first defecation and the time of the first flatus and secondary outcomes including the level of Ghrelin (GHRL) and the incidence of postoperative complications. Meanwhile, the safety of this trial was evaluated. Results: There was no statistical difference in baseline characteristics among the three groups. For the time of the first flatus, XBP group (22.33 ± 6.68 h) showed less time compared with the chewing gum group (23.06 ± 7.37 h), while it was shorter than that in the blank control group (25.86 ± 7.93 h) with significant difference (P < 0.05). As for the time of the first defecation, XBP group (38.65 ± 12.96 h) showed shorter time significantly compared with both the chewing gum group (47.29 ± 14.50 h) and the blank control group (54.01 ± 20.32 h) (P < 0.05). For the postoperative GHRL levels, XBP group was higher than that in the chewing gum group with no significant difference and had more significant improvement of the GHRL levels at postoperative day 3 compared with the blank control group (P < 0.05). For postoperative complications, XBP group had lower incidence than the other two groups but with no significant difference. For safety evaluations, no serious adverse events occurred in the three groups. Conclusions: XBP could promote the recovery of gastrointestinal function after gynecological abdominal surgery and it is overall safe. Trial registration: This trial was retrospectively registered by Chinese Clinical Trial Registry with the identifier number, ChiCTR1900026327, at September 30, 2019. http://www.chictr.org.cn/.

scholarly journals Postmortem Determination of Short-Term Markers of Hyperglycemia for the Purposes of Medicolegal Opinions

Diagnostics ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. 236
Author(s):  
Karolina Nowak ◽  
Tomasz Jurek ◽  
Marcin Zawadzki
Keyword(s):  
Blood Serum ◽  
Control Group ◽  
Test Results ◽  
Short Term ◽  
Biochemical Tests ◽  
Postmortem Diagnosis ◽  
Autopsy Report ◽  
Significant Difference ◽  
Postmortem Blood ◽  
Medicolegal Assessment

Diabetes mellitus is classified as the epidemic of the 21st century. Due to the fact that acute carbohydrate metabolism disorders usually do not indicate morphological change, postmortem diagnosis is required to perform biochemical tests. The authors decided to evaluate the usefulness of determining glucose, lactate, acetone, β-hydroxybutyric acid (BHB), and 1,5-anhydroglucitol (1,5-AG) in postmortem blood/serum, urine, and vitreous humor (VH). Biological material was collected during autopsies. The study group consisted of 50 diabetics, while the control group consisted of 50 non-diabetics, who died a sudden death, with negative test results for the presence of ethyl alcohol and were not resuscitated before death. Statistical analysis was performed using the IBM SPSS Statistics 25 software package. The most statistically significant difference between the two groups was observed for mean 1,5-AG concentration. The authors found many correlations between the concentration of the examined markers in different materials, mainly between blood/serum and VH. The most suitable short-term glycemic marker in postmortem diagnosis is 1,5-AG. Diagnosis may be supported with determinations of acetone and BHB. For medicolegal assessment, the interpretation of the biochemical test results should comprise information on circumstances of death, medical history, results of other toxicological and histopathological tests, and autopsy report.

scholarly journals Assessment of Novel Inhaler Technique Reminder Labels in Image Format on the Correct Demonstration of Inhaler Technique Skills in Asthma: A Single-Blinded Randomized Controlled Trial

2021 ◽  
Vol 14 (2) ◽  
pp. 150
Author(s):  
Iman Basheti ◽  
Bassam Mahboub ◽  
Laila Salameh ◽  
Mena Al-Ani ◽  
Ammar Abdulrahman Jairoun ◽  
...  
Keyword(s):  
Asthma Control ◽  
Educational Intervention ◽  
Active Group ◽  
Controlled Study ◽  
Dose Inhaler ◽  
Control Group ◽  
Inhaler Technique ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Image Format

Background: Prevalence of asthma in the United Arab Emirates (UAE) is high, and training patients on correct inhaler technique is vital. Objectives: To assess the effectiveness of inhaler technique labels incorporating the individual technique steps in image format on the retention of correct inhaler technique for patients with asthma living in the UAE and following inhaler training; secondly to investigate the effect of inhaler technique education using self-check pictorial labels on patients’ overall asthma control. Methods: This single-blinded randomized controlled study was conducted in 2019 and followed consecutive recruitment of asthma patients visiting respiratory clinics at Rashid Hospital in Dubai. Patients were using a controller inhaler (Turbuhaler (TH), Accuhaler (ACC), or pressurized metered-dose inhaler (pMDI)). Following recruitment, patients were randomized into active group receiving educational intervention plus the inhaler label, and control group receiving educational intervention without the label. Patients were assessed at baseline and at one-month on their inhaler technique and asthma control. Results: Participants (n = 245; 93 = TH, 70 = ACC, 82 = pMDI) showed a significant difference between the groups at one-month for inhaler technique scores for TH (active 5.29 ± 1.86 vs. control = 24.4 ± 21.28), ACC (active = 3.99 ± 1.43 vs. control = 25.45 ± 22.57), and pMDI (active = 4.59 ± 0.10 vs. control = 120.55 ± 17.2), p < 0.001 for all. Asthma control for active group indicated significant improvements compared to control for TH and pMDI (p < 0.001 for both), but not ACC group (p = 0.087). Conclusions: Retention of correct inhaler technique and improved asthma control can be enhanced by using a specialized inhaler technique label in image format.

The influence of vitamin D intake on serum calcium in tuberculosis

1981 ◽  
Vol 97 (1) ◽  
pp. 114-117 ◽  
Author(s):  
Grant Gwinup ◽  
Guy Randazzo ◽  
Alan Elias
Keyword(s):  
Vitamin D ◽  
Serum Calcium ◽  
Calcium Concentration ◽  
Dietary Vitamin ◽  
Controlled Study ◽  
Control Group ◽  
Serum Calcium Concentration ◽  
Significant Difference ◽  
Supplemental Vitamin ◽  
Prospective Controlled Study

Abstract. We report the first prospective controlled study designed to determine the effect of vitamin D ingestion on serum calcium concentration in patients with tuberculosis. Every patient admitted to the tuberculosis ward over a 6 month period, who was free of any condition which might influence serum calcium concentration, was randomly assigned to one of two groups. The diet of the first group was substituted with ergocalciferol 5000 units daily. The diet of the second group was not supplemented. In addition, the second group was randomly subdivided into two subgroups. The first subgroup received a diet unrestricted in vitamin D. The second subgroup received a diet containing less than 50 units of vitamin D. Serum calcium was determined at weekly intervals. In contradistinction to the results of a previously reported retrospective study, there was no significant difference between the group receiving supplemental vitamin D and the control group at any time during the entire period of study. Furthermore, there was no significant difference between the subgroup of patients receiving normal dietary vitamin D and the sungroup maintained on the diet restricted in vitamin D.

scholarly journals Effects of daily mindfulness practice on fatigue, kinesiophobia, and quality of life in patients with acute myocardial infarction: a randomized controlled trial

2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
C Karadas ◽  
M Oksul ◽  
N Ozer ◽  
L Ozdemir
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Mindfulness Practice ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Quality Of Life Scale ◽  
Tampa Scale For Kinesiophobia

Abstract Funding Acknowledgements Type of funding sources: None. Background and Aim Mindfulness meditation (MM) leads to controlled blood pressure and positive improvements in other symptoms which may trigger acute coronary diseases. The present randomized controlled study was aimed to investigate the effect of the MM on fatigue, kinesiophobia, and the quality of life (QoL) in patients with acute MI. Method The study was carried out with 56 MI patients. Participants were randomly assigned to meditation group (MG; n = 28) or control group (CG; n = 28).  The MG patients received a 15 min MM session comprising sitting and breathing for a total of eight weeks, while the CG patients received only a single-time attention-matched education. Piper Fatigue Intervention, Tampa Scale for Kinesiophobia-Heart and MacNew Quality of Life scales were utilized for data collection. Results After completion of the 8-week MM, any significant difference was not found in the fatigue scores of the patients (p &gt; 0.05). On the other hand, kinesiophobia scores in the MG were significantly lower in the 4th, 8th and 12th weeks (p &lt; 0.05). Similarly, the QoL scores were significantly higher in the MG in 8th week (p &lt; 0.05). Significant change in the emotional function sub-dimension of QoL continued in the follow-up assessment at 12th week (p &lt; 0.05). Conclusion The MM can significantly improve the QoL and decrease kinesiophobia in patients with MI. Beneficial effect of MM is maintained particularly in the emotional aspect. Based on the results of the study, MM may be recommended as a mind-body based complementary approaches within the scope of secondary protection after MI. Comparison of the study groupsGroupBaseline(Mean ± SD)4th week(Mean ± SD)8th week(Mean ± SD)12th week(Mean ± SD)PFSMM2.08 ± 1.870.90 ± 0.990.47 ± 0.780.44 ± 0.76CG1.56 ± 2.011.12 ± 1.590.98 ± 1.520.76 ± 1.33tp1.004 0.32-0.6210.54-1.5840.12-1.0850.28TSK-HMM40.25 ± 5.0436.18 ± 4.4934.39 ± 4.6134.96 ± 4.71CG41.71 ± 7.2841.89 ± 6.7441.82 ± 5.8441.00 ± 5.54tp-0.8750.39-3.7340.001-5.279 0.000-4.3900.00MacNewMM5.04 ± 0.715.53 ± 0.455.76 ± 0.475.77 ± 0.47CG5.17 ± 0.855.32 ± 0.605.37 ± 0.525.53 ± 0.46t; p-0.640; 0.531.436; 0.162.933; 0.0051.964; 0.06(Mean ± SD): Mean ± Standard Deviation; PFS: Piper Fatigue Scores; TSK-H: Tampa Scale for Kinesiophobia-Heart; MacNew: MacNew Quality of life Scale; EFS: emotional functioning sub-dimension; PFS: physical functioning sub-dimension; SFS: social functioning sub-dimension; t= Student T Test value; p&lt; 0.05

scholarly journals The Effects of 6-Month Vitamin D Supplementation during the Non-Surgical Treatment of Periodontitis in Vitamin-D-Deficient Patients: A Randomized Double-Blind Placebo-Controlled Study

Nutrients ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 2940
Author(s):  
Marina Perić ◽  
Dominique Maiter ◽  
Etienne Cavalier ◽  
Jérôme F. Lasserre ◽  
Selena Toma
Keyword(s):  
Vitamin D ◽  
Vitamin D3 ◽  
Test Group ◽  
Controlled Study ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Pocket Depth ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

Background: This study assessed the effects of weekly vitamin D (VD) supplementation on clinical and biological parameters after scaling and root planning (SRP) in the treatment of periodontitis and served to validate the VD dosage regimen. Methods: It was a monocentric, randomized, double-blind, placebo-controlled clinical trial with 6 months follow-up. Healthy Caucasian periodontitis patients presenting serum 25(OH) vitamin D3 below 30 ng/mL were randomly allocated to test group (SRP + VD 25,000 international units (IU)/week) or the control group (SRP + placebo). Results: A total of 59 patients were screened, 27 were included and 26 completed 3 months (M) and 21 completed 6M control. Test (n = 13) and control groups (n = 14) had similar 25(OH) vitamin D3 levels at baseline (17.6 ± 7.4 vs. 14.4 ± 5.2, respectively). After one month, there was a significant difference between groups (32.9 ± 5.2 vs. 16.1 ± 4.7), also seen at M3 and M6 (t-test, p < 0.001). Periodontal treatment was successful in both groups, since it resulted in a reduction of all measured clinical parameters at M3 and M6 (probing pocket depth (PPD), full mouth bleeding and plaque). However, the reduction in PPD was greater in the test group. Conclusions: In this short-term pilot study, no significant differences were observed between two groups. However, supplementation with VD tended to improve the treatment of periodontitis in patients with initial 25(OH) vitamin D3 < 30 ng/mL and proved safe and efficacious. NCT03162406.

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