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Self-compression Technique vs Standard Compression in Mammography: A Randomized Clinical Trial.

ABSTRACT: Importance:Many women dread undergoing mammography, and some may not attend or reattend breast cancer screening because of the discomfort or pain induced by breast compression. Objective:To evaluate the noninferiority of the self-compression mammography technique for reducing breast thickness compared with standard compression. Design, Setting, and Participants:This prospective, parallel-group, noninferiority randomized clinical trial was conducted from May 7, 2013, to October 26, 2015, at 6 cancer care centers in France. Participants were women aged 50 to 75 years, without a history of recent breast surgical procedure or treatment, and who could perform self-compression. Analyses were performed on intention-to-treat basis from January 27, 2017, to March 30, 2018. Interventions:Patients were randomized 1:1 to the self-compression group or the standard compression group. Main Outcomes and Measures:Primary end point was breast thickness expressed as the mean of 4 views: right and left craniocaudal and right and left mediolateral oblique. The predefined noninferiority margin was a difference of 3 mm, with a 1-sided 95% CI. Secondary end points included compression force, image quality, requirement for additional views, pain, and patient satisfaction and radiographer assessment questionnaires. Results:Among the 549 women randomized, 548 (97.3%) completed the trial. Of these, 275 (48.8%) (mean [SD] age, 61.35 [6.34] years) were randomized to the self-compression arm and 273 (48.5%) (mean [SD] age, 60.84 [6.41] years) to the standard compression arm. The difference in the mean thickness between the 2 arms was lower than the noninferiority margin, with an upper 1-sided 95% CI less than 3 mm (-0.17; 95% CI,-? to 1.89 mm; P?

SUBMITTER: Henrot P

PROVIDER: S-EPMC6440229 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Self-compression Technique vs Standard Compression in Mammography: A Randomized Clinical Trial.

Henrot Philippe P Boisserie-Lacroix Martine M Boute Véronique V Troufléau Philippe P Boyer Bruno B Lesanne Grégory G Gillon Véronique V Desandes Emmanuel E Netter Edith E Saadate Maryam M Tardivon Anne A Grentzinger Christine C Salleron Julia J Oldrini Guillaume G

JAMA internal medicine 20190301 3

<h4>Importance</h4>Many women dread undergoing mammography, and some may not attend or reattend breast cancer screening because of the discomfort or pain induced by breast compression.<h4>Objective</h4>To evaluate the noninferiority of the self-compression mammography technique for reducing breast thickness compared with standard compression.<h4>Design, setting, and participants</h4>This prospective, parallel-group, noninferiority randomized clinical trial was conducted from May 7, 2013, to Octo ...[more]

PMID: 30715083

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Project description:ImportanceSelf-measured blood pressure (SMBP) with commercially available connected smartphone applications may help patients effectively use SMBP measurements.ObjectiveTo determine if enhanced SMBP paired with a connected smartphone application was superior to standard SMBP for blood pressure (BP) reduction or patient satisfaction.Design, setting, and participantsThis randomized clinical trial was conducted among 23 health systems participating in PCORnet, the National Patient-Centered Clinical Research Network, and included patients who reported having uncontrolled BP at their last clinic visit, a desire to lower their BP, and a smartphone. Enrollment and randomization occurred from August 3, 2019, to December 31, 2020, which was followed by 6 months of follow-up for each patient. Analysis commenced shortly thereafter.InterventionsEligible participants were randomly assigned to enhanced SMBP using a device that paired with a connected smartphone application (enhanced) or a standard device (standard). Participants received their device in the mail, along with web-based educational materials and phone-based support as needed. No clinician engagement was undertaken, and the study provided no special mechanisms for delivering measurements to clinicians for use in BP management.Main outcomes and measuresReduction in systolic BP, defined as the difference between clinic BP at baseline and the most recent clinic BP extracted from electronic health records at 6 months.ResultsEnrolled participants (1051 enhanced [50.0%] vs 1050 standard [50.0%]; 1191 women [56.7%]) were mostly middle-aged or older (mean [SD] age, 58 [13] years), nearly a third were Black or Hispanic (645 [31%]), and most were relatively comfortable using technology (mean [SD], 4.1 [1.1] of 5). The mean (SD) change in systolic BP from baseline to 6 months was -10.8 (18) mm Hg vs -10.6 (18) mm Hg (enhanced vs standard: adjusted difference, -0.19 mm Hg; 95% CI, -1.83 to 1.44; P = .81). Secondary outcomes were mostly null, except for documented attainment of BP control to lower than 140/<90 mm Hg, which occurred in 32% enhanced vs 29% standard groups (odds ratio, 1.15; 95% CI, 1.01-1.34). Most participants were very likely to recommend their SMBP device to a friend (70% vs 69%).Conclusions and relevanceThis randomized clinical trial found that enhanced SMBP paired with a smartphone application is not superior to standard SMBP for BP reduction or patient satisfaction.Trial registrationClinicalTrials.gov Identifier: NCT03796689.

Project description:ImportanceAlthough international guidelines recommend use of the Global Registries of Acute Coronary Events (GRACE) risk score (GRS) to guide acute coronary syndrome (ACS) treatment decisions, the prospective utility of the GRS in improving care and outcomes is unproven.ObjectiveTo assess the effect of routine GRS implementation on guideline-indicated treatments and clinical outcomes of hospitalized patients with ACS.Design, setting, and participantsProspective cluster (hospital-level) randomized open-label blinded end point (PROBE) clinical trial using a multicenter ACS registry of acute care cardiology services. Fixed sampling of the first 10 patients within calendar month, with either ST-segment elevation or non-ST-segment elevation ACS. The study enrolled patients from June 2014 to March 2018, and data were analyzed between February 2020 and April 2020.InterventionsImplementation of routine risk stratification using the GRS and guideline recommendations.Main outcomes and measuresThe primary outcome was a performance score based on receipt of early invasive treatment, discharge prescription of 4 of 5 guideline-recommended pharmacotherapies, and cardiac rehabilitation referral. Clinical outcomes included a composite of all-cause death and/or myocardial infarction (MI) within 1 year.ResultsThis study enrolled 2318 patients from 24 hospitals and was stopped prematurely owing to futility. Of the patients enrolled, median age was 65 years (interquartile range, 56-74 years), 29.5% were women (n = 684), and 62.9% were considered high risk (n = 1433). Provision of all 3 measures among high-risk patients did not differ between the randomized arms (GRS: 424 of 717 [59.9%] vs control: 376 of 681 [55.2%]; odds ratio [OR], 1.04; 95% CI, 0.63-1.71; P = .88). The provision of early invasive treatment was increased compared with the control arm (GRS: 1042 of 1135 [91.8%] vs control: 989 of 1183 [83.6%]; OR, 2.26; 95% CI, 1.30-3.96; P = .004). Prescription of 4 of 5 guideline-recommended pharmacotherapies (GRS: 864 of 1135 [76.7%] vs control: 893 of 1183 [77.5%]; OR, 0.97; 95% CI, 0.68-1.38) and cardiac rehabilitation (GRS: 855 of 1135 [75.1%] vs control: 861 of 1183 [72.8%]; OR, 0.68; 95% CI, 0.32-1.44) were not different. By 12 months, GRS intervention was not associated with a significant reduction in death or MI compared with the control group (GRS: 96 of 1044 [9.2%] vs control: 146 of 1087 [13.4%]; OR, 0.66; 95% CI, 0.38-1.14).Conclusions and relevanceRoutine GRS implementation in cardiology services with high levels of clinical care was associated with an increase in early invasive treatment but not other aspects of care. Low event rates and premature study discontinuation indicates the need for further, larger scale randomized studies.Trial registrationanzctr.org.au Identifier: ACTRN12614000550606.

Project description:ImportanceThere are currently no proven treatments to reduce the risk of mild cognitive impairment and dementia.ObjectiveTo evaluate the effect of intensive blood pressure control on risk of dementia.Design, setting, and participantsRandomized clinical trial conducted at 102 sites in the United States and Puerto Rico among adults aged 50 years or older with hypertension but without diabetes or history of stroke. Randomization began on November 8, 2010. The trial was stopped early for benefit on its primary outcome (a composite of cardiovascular events) and all-cause mortality on August 20, 2015. The final date for follow-up of cognitive outcomes was July 22, 2018.InterventionsParticipants were randomized to a systolic blood pressure goal of either less than 120 mm Hg (intensive treatment group; n = 4678) or less than 140 mm Hg (standard treatment group; n = 4683).Main outcomes and measuresThe primary cognitive outcome was occurrence of adjudicated probable dementia. Secondary cognitive outcomes included adjudicated mild cognitive impairment and a composite outcome of mild cognitive impairment or probable dementia.ResultsAmong 9361 randomized participants (mean age, 67.9 years; 3332 women [35.6%]), 8563 (91.5%) completed at least 1 follow-up cognitive assessment. The median intervention period was 3.34 years. During a total median follow-up of 5.11 years, adjudicated probable dementia occurred in 149 participants in the intensive treatment group vs 176 in the standard treatment group (7.2 vs 8.6 cases per 1000 person-years; hazard ratio [HR], 0.83; 95% CI, 0.67-1.04). Intensive BP control significantly reduced the risk of mild cognitive impairment (14.6 vs 18.3 cases per 1000 person-years; HR, 0.81; 95% CI, 0.69-0.95) and the combined rate of mild cognitive impairment or probable dementia (20.2 vs 24.1 cases per 1000 person-years; HR, 0.85; 95% CI, 0.74-0.97).Conclusions and relevanceAmong ambulatory adults with hypertension, treating to a systolic blood pressure goal of less than 120 mm Hg compared with a goal of less than 140 mm Hg did not result in a significant reduction in the risk of probable dementia. Because of early study termination and fewer than expected cases of dementia, the study may have been underpowered for this end point.Trial registrationClinicalTrials.gov Identifier: NCT01206062.

Project description:Despite the high success rates of preformed metal crowns (PMCs) in children no randomized clinical trials compare methods of placement and none describe its use in Africa. Our aim was to compare survival and cost-effectiveness of PMCs placed by conventional techniques (CT) and biological Hall techniques (HT) using a prospective randomized control trial in a general dental practice from Khartoum. One hundred and nine and 103 PMCs were placed in randomly selected children (5-8years) with 1-2 carious primary molars using HT and CT respectively and followed for 2 years. Socioeconomic status, periodontal health, occlusion, anxiety, and procedure time were compared using student t-test. Kaplan-Meier survival rates and incremental cost effectiveness ratio (ICER) were compared between CT and HT. CT and HT groups were similar for age, gender, socio-economic status. Survival rates were high (over 90%) for both study arms and not statistically different (p>0.05). Anxiety scores were significantly higher in CT arm after 12 months compared to HT (p<0.001). Clinically, gingival and plaque indices were similar between groups (p>0.05) but occlusions were raised in nearly all subjects in the HT arm (p<0.05). Periodontal health improved, and occlusions adjusted over time in both arms. There were 3 (2.7%) and 6 (5.8%) minor failures, 7 (6.4%) and 6 (5.8%) major failures in HT and CT arms respectively. Mean procedure time was lower in HT (9.1 min) than CT (33.9 min); p<0.001. Mean PMC cost was US$2.45 and US$7.81 for HT and CT respectively. The ICER was US$136.56 more for each PMC placed by CT per life year. We show that PMCs have high survival outcomes in disadvantaged populations similar to results from developed countries. As HT can be carried out by less experienced dental operators and therapists, this biological approach provides a promising cost-effective option to manage caries in developing countries with limited resources. Trial registration: The trial is registered at clinicaltrials.gov. ClinicalTrial.gov Trial Registration: NCT03640013.

Project description:ImportanceAcute bacterial sinusitis is common, but currently recommended antibiotic treatment provides minimal benefit.ObjectiveTo confirm the previous finding that high-dose amoxicillin plus clavulanate (with double the amount of amoxicillin) may be superior to standard-dose amoxicillin plus clavulanate in adults.Design, setting, and participantsThis double-blind, comparative-effectiveness randomized clinical trial was conducted from February 26, 2018, through May 10, 2020, at the academic primary care internal medicine and pediatrics practice of Albany Medical Center, located in Cohoes, New York. Participants included adults aged 18 years or older who were prescribed amoxicillin plus clavulanate for acute bacterial sinusitis diagnosed in accordance with the Infectious Diseases Society of America guidelines.InterventionsAmoxicillin 875 mg with clavulanate 125 mg plus either placebo (standard dose) or amoxicillin 875 mg (high dose) twice a day for 7 days.Main outcomes and measuresThe primary efficacy outcome was a global rating of "a lot better" or "no symptoms" at the end of 3 days of treatment using a Global Rating of Improvement scale, with outcomes ranging from 1 (a lot worse) to 6 (no symptoms). The primary adverse effect outcome was severe diarrhea at 3 or 10 days after the start of treatment.ResultsAt an unplanned interim analysis prompted by COVID-19 restrictions, 157 of a projected 240 participants had been enrolled (mean age, 48.5 [range, 18.7-84.0] years; 117 women [74.5%]), with 79 randomized to the standard dose and 78 to the high dose; 9 and 12, respectively, withdrew or were lost to follow-up before the assessment of the primary outcome. At day 3, 31 of 70 participants (44.3%) in the standard-dose group reported a global rating of "a lot better" or "no symptoms," as did 24 of 66 (36.4%) in the high-dose group, for a difference of -7.9% (95% CI, -24.4% to 8.5%; P = .35). The study was, therefore, stopped for futility. Diarrhea was common in both groups by day 3, with any diarrhea reported in 29 of 71 participants (40.8%) receiving the standard dose and 28 of 65 (43.1%) receiving the high dose and severe diarrhea reported in 5 of 71 (7.0%) and 5 of 65 (7.7%), respectively.Conclusions and relevanceThe results of this randomized clinical trial suggest that adults treated for clinically diagnosed acute sinusitis did not appear to benefit from taking high-dose compared with standard-dose amoxicillin plus clavulanate.Trial registrationClinicalTrials.gov Identifier: NCT03431337.

Project description:AimTo study the significance of cap-fitted colonoscopy in improving cecal intubation time and polyp detection rate.MethodsThis study was a prospective randomized controlled trial conducted from March 2008 to February 2009 in a tertiary referral hospital at Sydney. The primary end point was cecal intubation time and the secondary endpoint was polyp detection rate. Consecutive cases of total colonoscopy over a 1-year period were recruited. Randomization into either standard colonoscopy (SC) or cap-assisted colonoscopy (CAC) was performed after consent was obtained. For cases randomized to CAC, one of the three sizes of cap was used: D-201-15004 (with a diameter of 15.3 mm), D-201-14304 (14.6 mm) and D-201-12704 (13.0 mm). All of these caps were produced by Olympus Medical Systems, Japan. Independent predictors for faster cecal time and better polyp detection rate were also determined from this study.ResultsThere were 200 cases in each group. There was no significant difference in terms of demographic characteristics between the two groups. CAC, when compared to the SC group, had no significant difference in terms of cecal intubation rate (96.0% vs 97.0%, P = 0.40) and time (9.94 +/- 7.05 min vs 10.34 +/- 6.82 min, P = 0.21), or polyp detection rate (32.8% vs 31.3%, P = 0.75). On the subgroup analysis, there was no significant difference in terms of cecal intubation time by trainees (88.1% vs 84.8%, P = 0.40), ileal intubation rate (82.5% vs 79.0%, P = 0.38) or total colonoscopy time (23.24 +/- 13.95 min vs 22.56 +/- 9.94 min, P = 0.88). On multivariate analysis, the independent determinants of faster cecal time were consultant-performed procedures (P < 0.001), male patients (P < 0.001), non-usage of hyoscine (P < 0.001) and better bowel preparation (P = 0.01). The determinants of better polyp detection rate were older age (P < 0.001), no history of previous abdominal surgery (P = 0.04), patients not having esophagogastroduodenoscopy in the same setting (P = 0.003), trainee-performed procedures (P = 0.01), usage of hyoscine (P = 0.01) and procedures performed for polyp follow-up (P = 0.01). The limitations of the study were that it was a single-center experience, no blinding was possible, and there were a large number of endoscopists.ConclusionCAC did not significantly different from SC in term of cecal intubation time and polyp detection rate.

Project description:ObjectivesTo reduce pain and discomfort associated with breast compression in mammography, a pressure-controlled compression paddle was recently introduced. The objective was to evaluate the pressure-controlled paddle by comparing it to the standard force-controlled paddle.MethodsDifferences of compressed breast thickness (CBT), compression force, compression pressure, and average glandular dose (AGD) between annual follow-up full-field digital mammography exams of 3188 patients were retrospectively examined. Two groups were compared: (1) force-force group (FF-group), both examinations were performed with the force-controlled paddle, and (2) force-pressure group (FP-group), only the follow-up examination was performed with the pressure-controlled paddle. In an additional group of patients, pain scores on a scale of 0 (no pain at all) to 10 (worst pain imaginable) were evaluated prospectively (n?=?343) who were randomly assigned to either paddle.ResultsMedian differences between follow-up exams in CBT, compression force, compression pressure, and AGD were for the FF- and FP-group respectively -?1.0 vs 0.0 mm (p?<?0.001); 0.0 vs?-?1.0 daN (p?=?0.002); -?1.0 vs -?0.5 kPa (p?=?0.005); and 0.05 vs -?0.02 mGy (p?<?0.001). These differences were, although statistically significant, clinically non-relevant (defined as ?CBT >?±?2 mm; ?force >?±?2 daN; ?pressure >?±?1 kPa and ?AGD >?±?0.1 mGy). The subanalysis dividing CBT into five categories revealed similar results. The median [interquartile range] pain scores were 6 [3, 7] and 5 [3, 7] for the force-controlled and pressure-controlled paddle, respectively, which was not significantly different (p?=?0.113).ConclusionsWe observed no clinically relevant differences in CBT, compression force, compression pressure, AGD, or pain score between the force- and pressure-controlled paddle. As such, we found no basis for preferring one paddle over the other.Key points• The pressure-controlled paddle did not show any clinically relevant changes in breast compression parameters compared to the force-controlled paddle. • The pressure-controlled paddle did not lead to significant reduction in pain scores indicated by the patients compared to the force-controlled paddle. • A large variation in compression force and compression pressure was observed in mammography exams for the both the force- and pressure-controlled compression paddle.

Dataset Information

Self-compression Technique vs Standard Compression in Mammography: A Randomized Clinical Trial.

Publications

Self-compression Technique vs Standard Compression in Mammography: A Randomized Clinical Trial.

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