Similar Proportions Of Participants Research Articles

Smoke into Sound: A pilot randomised controlled trial of a music cravings management program for chronic smokers attempting to quit

Chronic smokers display greater cravings and higher dependence on nicotine than smokers who successfully quit, which indicates a need for novel interventions that address cravings. Smoke into Sound is an online interactive program that uses personalised music-listening to assist participants to manage emotional states and cravings that act as cues for their smoking. This study describes a pilot randomised trial of Smoke into Sound (MUSIC) in comparison to current best practice cognitive behaviour therapy programs delivered online and by telephone (CBTE) or by telephone only (CBTT). Participants were 55 chronic smokers aged 18 to 66 years (45% females) who completed an online questionnaire before being randomly assigned to one of the three conditions: MUSIC, CBTE or CBTT. The 38 participants remaining 6 weeks later completed a post-program online questionnaire to assess smoking status; craving strength; self-efficacy for cessation; and confidence in regulating emotions without smoking. Almost half (45%) of the sample had stopped smoking at the post-program assessment, with similar proportions of participants in each condition no longer smoking. Participants in the MUSIC and CBTE conditions had greater reductions in craving strength and improvements in emotion regulation than those in the CBTT. The findings indicate that chronic smokers responded equally well to the music emotion regulation strategies as to the CBT strategies for smoking cessation. Smoke into Sound is the first program to our knowledge that applies music psychology theory to an intervention for addictive behaviour.

Noví mladí Masaryci? Podpora demokracie a jejích principů u českých adolescentů

This article investigates levels and predictors of support for democracy and two democratic principles (free speech and minority rights) among Czech 14- to 17-year-olds. An analysis of survey data collected in primary and secondary schools in four regions in 2014 (N = 1,959) reveals that among young Czechs general support for a democratic regime is relatively independent from more specific pro-democratic attitudes (although there is an association between general support for democracy and the abstract principle of freedom of speech). On a general level, democracy was supported by about two-thirds of adolescents in the sample. Similar or even higher levels of support were found for the two principles of democracy when presented in abstract terms. However, when these principles were presented to them in specific, less clear-cut contexts, support for them was much lower. Specifically, despite their strong support for free speech, about half of respondents supported restricting unconventional political activism. Moreover, a similar proportion of participants seemed to downplay minority rights when the majority rule was emphasised. Results of the analysis also revealed that support for different aspects of democracy was predicted by various psychological and socioeconomic factors.

Abstract P199: Development of an Algorithm for Identifying Fatal Cardiovascular Disease in Medicare Claims

Introduction: Administrative claims data including Medicare are often used to study cardiovascular disease (CVD). Approximately one-third of CVD events are fatal, but claims data lack information on cause of death and claims-based analyses only include non-fatal outcomes. Objective: To develop claims-based algorithms to discriminate fatal stroke, fatal coronary heart disease (CHD), and fatal CVD (fatal CHD or stroke) from deaths due to other causes. Methods: We analyzed data for REasons for Geographic and Racial Differences in Stroke (REGARDS) study participants who died between January, 1, 2003 and December, 31, 2013, and were age ≥65.5 years and had at least 182 consecutive days of fee-for service Medicare coverage prior to their death. Deaths within 28 days following an expert-adjudicated stroke, CHD, and CVD event in REGARDS were defined as the gold standard. Logistic regression was used to develop algorithms including demographic data, ICD-9-CM diagnosis and procedure codes from Medicare claims for hospitalization and outpatient visits. We chose cut-points of predicted probability to define fatal stroke, CHD and CVD using these algorithms. Cut-points were chosen such that a similar proportion of participants had a fatal stroke, fatal CHD, and fatal CVD through REGARDS adjudication and the algorithms. Results: We analyzed data for 2,675 deaths among REGARDS study participants; 142 fatal strokes, 479 fatal CHD events, and 608 fatal CVD events. The algorithms are described in the footnote to the Table. C-statistics for the algorithms were 0.966 (95%CI 0.948, 0.980) for fatal stroke, 0.861 (95%CI 0.843, 0.878) for fatal CHD and 0.883 (95%CI 0.868, 0.898) for fatal CVD. Sensitivity, specificity, and positive and negative predictive values using cut-points of 24%, 30%, and 34% predicted probabilities for fatal stroke, fatal CHD and fatal CVD, respectively, are provided in the Table. Conclusion: The algorithms we developed can be used to identify Medicare beneficiaries with fatal CVD events.

Factors Associated With Shorter Colonoscopy Surveillance Intervals for Patients With Low-Risk Colorectal Adenomas and Effects on Outcome

Endoscopists do not routinely follow guidelines to survey individuals with low-risk adenomas (LRAs; 1-2 small tubular adenomas, < 1 cm) every 5-10 years for colorectal cancer; many recommend shorter surveillance intervals for these individuals. We aimed to identify the reasons that endoscopists recommend shorter surveillance intervals for some individuals with LRAs and determine whether timing affects outcomes at follow-up examinations. We collected data from 1560 individuals (45-75 years old) who participated in a prospective chemoprevention trial (of vitamin D and calcium) from 2004 through 2008. Participants in the trial had at least 1 adenoma, detected at their index colonoscopy, and were recommended to receive follow-up colonoscopy examinations at 3 or 5 years after adenoma identification, as recommended by the endoscopist. For this analysis we collected data from only participants with LRAs. These data included characteristics of participants and endoscopists and findings from index and follow-up colonoscopies. Primary endpoints were frequency of recommending shorter (3-year) vs longer (5-year) surveillance intervals, factors associated with these recommendations, and effect on outcome, determined at the follow-up colonoscopy. A 3-year surveillance interval was recommended for 594 of the subjects (38.1%). Factors most significantly associated with recommendation of 3-year vs a 5-year surveillance interval included African American race (relative risk [RR] to white, 1.41; 95% confidence interval [CI], 1.14-1.75), Asian/Pacific Islander ethnicity (RR to white, 1.7; 95% CI, 1.22-2.43), detection of 2 adenomas at the index examination (RR vs 1 adenoma, 1.47; 95% CI, 1.27-1.71), more than 3 serrated polyps at the index examination (RR=2.16, 95% CI, 1.59-2.93), or index examination with fair or poor quality bowel preparation (RR vs excellent quality, 2.16; 95% CI, 1.66-2.83). Other factors that had a significant association with recommendation for a 3-year surveillance interval included family history of colorectal cancer and detection of 1-2 serrated polyps at the index examination. In comparisons of outcomes, we found no significant differences between the 3-year vs 5-year recommendation groups in proportions of subjects found to have 1 or more adenomas (38.8% vs 41.7% respectively; P=.27), advanced adenomas (7.7% vs 8.2%; P=.73) or clinically significant serrated polyps (10.0% vs 10.3%; P= .82) at the follow-up colonoscopy. Possibly influenced by patients' family history, race, quality of bowel preparation, or number or size of polyps, endoscopists frequently recommend 3-year surveillance intervals instead of guideline-recommended intervals of 5 years or longer for individuals with LRAs. However, at the follow-up colonoscopy, similar proportions of participants have 1 or more adenomas, advanced adenomas, or serrated polyps. These findings support the current guideline recommendations of performing follow-up examinations of individuals with LRAs at least 5 years after the index colonoscopy.

Prevalence, Pattern, and Correlates of Alcohol Misuse among Male Patients Attending Rural Primary Care in India.

Background:There are limited data available on how the problem of alcohol use is detected in primary care setting in India. Particularly in Odisha, it has not been investigated yet. This study was conducted to determine the prevalence of drinking, drinking patterns, and quitting behavior among the male patients visiting a primary health-care facility in a district of Odisha.Methodology:A cross-sectional study was conducted among patients attending community health center (CHC), Buguda in the state of Odisha, India, from December 1, 2014, to February 31, 2015. Patients above 18 years of age, conscious, and willing to participate in the study were included in the study, while those with cognitive impairment and critically ill were excluded from the study. All eligible consecutive patients attending outpatient department of CHC were invited to participate while they came out after physician's consultation. A pilot study was conducted prior to the study. Informed verbal consent from each patient was obtained before the interview. The study was approved by the Institutional Ethics Committee of Indian Institute of Public Health, Bhubaneswar.Results:A total of 431 patients were interviewed. Our study showed 38% (95% confidence interval [CI]: 33.5%–42.7%) of respondents were alcoholic and of those 60% (95% CI: 51.4%–66.5%) were hazardous drinkers. One in five patients had a history of alcoholics in their family, and a similar proportion of participants were heavy workers. Smokers were eight times (adjusted odds ratio [AOR] =7.56; 4.03–14.52) more likely to be alcoholics as compared to nonsmokers (P < 0.001), whereas the prevalence of alcohol drinking was four times (AOR = 3.94; 2.25–6.92) higher in smokeless tobacco users compared to nonusers.Conclusion:Focusing only on counseling and treatment services will not reduce the piling burden of alcohol use. It is important to target the environment that leads to such habits.

Open-label randomized non-inferiority trial of a fixed-dose combination of glimepiride and atorvastatin for the treatment of people whose Type 2 diabetes is uncontrolled on metformin.

To evaluate, in a randomized, open-label study, the non-inferiority of a bioequivalent fixed-dose combination of glimepiride and atorvastatin vs. separately co-administered tablets in people with Type 2 diabetes mellitus. Participants with HbA1c ≥53 to <80mmol/mol (≥7.0 to <9.5%), average fasting blood glucose >7.0mmol/l, who were on metformin for ≥3months, were randomized to combination (n=215) or co-administered glimepiride and atorvastatin (n=212) once daily for 20weeks. Up-titration of glimepiride (1-4mg) and atorvastatin (10-20mg) were based on average fasting blood glucose and LDL cholesterol, respectively. Co-primary endpoints were change from baseline to week 20 in HbA1c and LDL cholesterol. Non-inferiority was demonstrated for both co-primary endpoints: the upper limits of 95% CIs for differences (combination-reference) were less than the prespecified margins of 3.3mmol/mol (0.3%) for change from baseline in HbA1c [difference 0.1mmol/mol (95% CI -1.6, 1.9); 0.01% (95% CI -0.15, 0.17)] and 6% for percentage change from baseline in LDL cholesterol [difference 0.87% (95% CI -2.47, 4.21)]. Similar proportions of participants on combination and reference had treatment-emergent adverse events (64 vs. 61%). More participants on combination had hypoglycaemia (21 vs. 13%); most events were considered by the treating physician to be unrelated to study drug. The combination was non-inferior to separately co-administered tablets and the safety profile was consistent with the known profiles of glimepiride and atorvastatin. The observed increase in hypoglycaemia on the combination cannot be explained, but may be attributable to non-systematic collectiof glucose readings and may have been influenced by reporting bias in this open-label trial.

Inappropriate Care in European ICUs: Confronting Views From Nurses and Junior and Senior Physicians

ICU care providers often feel that the care given to a patient may be inconsistent with their professional knowledge or beliefs. This study aimed to assess differences in, and reasons for, perceived inappropriate care (PIC) across ICU care providers with varying levels of decision-making power.We present subsequent analysis from the Appropricus Study, a cross-sectional study conducted on May 11, 2010, which included 1,218 nurses and 180 junior and 227 senior physicians in 82 European adult ICUs. The study was designed to evaluate PIC. The current study focuses on differences across health-care providers regarding the reasons for PIC in real patient situations.By multivariate analysis, nurses were found to have higher PIC rates compared with senior and junior physicians. However, nurses and senior physicians were more distressed by perceived disproportionate care than were junior physicians (33%, 25%, and 9%, respectively; P = .026). A perceived mismatch between level of care and prognosis (mostly excessive care) was the most common cause of PIC. The main reasons for PIC were prognostic uncertainty among physicians, poor team and family communication, the fact that no one was taking the initiative to challenge the inappropriateness of care, and financial incentives to provide excessive care among nurses. Senior physicians, compared with nurses and junior physicians, more frequently reported pressure from the referring physician as a reason. Family-related factors were reported by similar proportions of participants in the three groups.ICU care providers agree that excessive care is a true issue in the ICU. However, they differ in the reasons for the PIC, reflecting the roles each caregiver has in the ICU. Nurses charge physicians with a lack of initiative and poor communication, whereas physicians more often ascribe prognostic uncertainty. Teaching ICU physicians to deal with prognostic uncertainty in more adequate ways and to promote ethical discussions in their teams may be pivotal to improving moral distress and the quality of patient care.

Single dose oral celecoxib for acute postoperative pain in adults.

This is an update of a review first published in The Cochrane Library in Issue 4, 2008, and updated in Issue 3, 2012. Celecoxib is a selective cyclo-oxygenase-2 (COX-2) inhibitor usually prescribed for the relief of chronic pain in osteoarthritis and rheumatoid arthritis. Celecoxib is believed to be associated with fewer upper gastrointestinal adverse effects than conventional non-steroidal anti-inflammatory drugs (NSAIDs). Its effectiveness in acute pain was demonstrated in the earlier reviews. To assess analgesic efficacy and adverse effects of a single oral dose of celecoxib for moderate to severe postoperative pain in adults. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Oxford Pain Database, and ClinicalTrials.gov. The most recent search was to 31 May 2013. We included randomised, double-blind, placebo-controlled trials (RCTs) of adults prescribed any dose of oral celecoxib or placebo for acute postoperative pain. Two review authors assessed studies for quality and extracted data. We converted summed pain relief (TOTPAR) or pain intensity difference (SPID) into dichotomous information, yielding the number of participants with at least 50% pain relief over four to six hours. We used this to calculate the relative benefit (RB) and number needed to treat to benefit (NNT), for one patient to achieve at least 50% of maximum pain relief with celecoxib who would not have done so with placebo. We used information on use of rescue medication to calculate the proportion of participants requiring rescue medication and the weighted mean of the median time to use. Ten studies (1785 participants) met the inclusion criteria. The two new studies in this update had been identified in the earlier update, but data were not available. There remain three potentially relevant unpublished studies for which data are not available at this time.The NNT for celecoxib 200 mg and 400 mg compared with placebo for at least 50% of maximum pain relief over four to six hours was 4.2 (95% confidence interval (CI) 3.4 to 5.6) and 2.6 (95% CI 2.3 to 3.0) respectively. The median time to use of rescue medication was 6.6 hours with celecoxib 200 mg, 8.4 hours with celecoxib 400 mg, and 2.3 hours with placebo. The proportion of participants requiring rescue medication over 24 hours was 74% with celecoxib 200 mg, 63% for celecoxib 400 mg, and 91% for placebo. The NNT to prevent one patient using rescue medication was 4.8 (95% CI 3.5 to 7.7) and 3.5 (95% CI 2.9 to 4.6) for celecoxib 200 mg and 400 mg respectively. Adverse events were generally mild to moderate in severity, and were experienced by a similar proportion of participants in the celecoxib and placebo groups. One serious adverse event that was probably related to celecoxib was reported. Single-dose oral celecoxib is an effective analgesic for postoperative pain relief. Indirect comparison suggests that the 400 mg dose has similar efficacy to ibuprofen 400 mg.

Single dose oral celecoxib for acute postoperative pain in adults.

This is an update of a review published in The Cochrane Library 2008, Issue 4. Celecoxib is a selective cyclo-oxygenase-2 (COX-2) inhibitor usually prescribed for the relief of chronic pain in osteoarthritis and rheumatoid arthritis. Celecoxib is believed to be associated with fewer upper gastrointestinal adverse effects than conventional non-steroidal anti-inflammatory drugs (NSAIDs). Its effectiveness in acute pain was demonstrated in the earlier reviews. To assess analgesic efficacy and adverse effects of a single oral dose of celecoxib for moderate to severe postoperative pain. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Oxford Pain Database, and ClinicalTrials.gov. The most recent search was to 3 January 2012. We included randomised, double-blind, placebo-controlled trials (RCTs) of adults prescribed any dose of oral celecoxib or placebo for acute postoperative pain. Two review authors assessed studies for quality and extracted data. We converted summed pain relief (TOTPAR) or pain intensity difference (SPID) into dichotomous information, yielding the number of participants with at least 50% pain relief over four to six hours, and used this to calculate the relative benefit (RB) and number needed to treat to benefit (NNT) for one patient to achieve at least 50% of maximum pain relief with celecoxib who would not have done so with placebo. We used information on use of rescue medication to calculate the proportion of participants requiring rescue medication and the weighted mean of the median time to use. Eight studies (1380 participants) met the inclusion criteria. We identified five potentially relevant unpublished studies in the most recent searches, but data were not available at this time. The number of included studies therefore remains unchanged.The NNT for celecoxib 200 mg and 400 mg compared with placebo for at least 50% of maximum pain relief over four to six hours was 4.2 (95% confidence interval (CI) 3.4 to 5.6) and 2.5 (2.2 to 2.9) respectively. The median time to use of rescue medication was 6.6 hours with celecoxib 200 mg, 8.4 with celecoxib 400 mg, and 2.3 hours with placebo. The proportion of participants requiring rescue medication over 24 hours was 74% with celecoxib 200 mg, 63% for celecoxib 400 mg, and 91% for placebo. The NNT to prevent one patient using rescue medication was 4.8 (3.5 to 7.7) and 3.5 (2.9 to 4.6) for celecoxib 200 mg and 400 mg respectively. Adverse events were generally mild to moderate in severity, and were experienced by a similar proportion of participants in celecoxib and placebo groups. One serious adverse event probably related to celecoxib was reported. Single-dose oral celecoxib is an effective analgesic for postoperative pain relief. Indirect comparison suggests that the 400 mg dose has similar efficacy to ibuprofen 400 mg.

Sleep-disordered breathing and excessive daytime sleepiness in chronic kidney disease and hemodialysis.

Sleep-disordered breathing (SDB) and excessive daytime sleepiness (EDS) are highly prevalent among hemodialysis (HD) patients. It is unclear to what extent SDB is associated with advanced chronic kidney disease (CKD; stages 4 to 5). This paper describes and compares the prevalence, severity, and patterns of SDB and EDS among patients with advanced CKD, HD-dependent patients, and community individuals without known renal disease. Eighty-nine CKD and 75 HD patients were compared with 224 participants from the Sleep-Strategies Concentrating on Risk Evaluation Sleep-SCORE study of sleep and cardiovascular risk. Participants had in-home unattended polysomnography for quantifying SDB. EDS was defined by a score ≥10 on the Epworth Sleepiness Scale. The sample had a median age 58.1 years, was predominantly male (57.4%) and white (62.5%), and had a median body mass index of 28.1 kg/m(2). Controls and Sleep-SCORE Study CKD patients had significantly higher median total sleep time and sleep efficiency compared with HD patients. The adjusted odds of severe SDB were higher for CKD and HD groups compared with the controls. Nocturnal hypoxemia was significantly elevated in the HD group compared with the CKD group. There were similar proportions of participants with EDS between the controls (33%), the CKD patients (29.3%), and the HD patients (40.6%). Severe SDB (predominantly obstructive) and EDS are common among advanced CKD and HD patients. EDS correlated modestly with severe SDB and its obstructive and mixed patterns in the HD group.

The Majority of Older British Columbians Take Vitamin D-containing Supplements

Health Canada recommends vitamin D supplements (10 microg/d) for Canadians aged > or = 50 years, but no data are available on adoption of this recommendation. Accordingly, this study was conducted to determine the current use of vitamin D supplements among British Columbian adults 50 years and over, and to explore relationships among vitamin D supplement use, socio-demographic variables, and knowledge, attitudes and beliefs about vitamin supplementation. A population-representative stratified sample, recruited by random-digit dialling, completed a telephone-administered survey in late fall of 2008. Respondents provided details on supplements used in the past month (dosage, frequency, etc.) and demographic data, and responded to statements reflecting health beliefs about supplements, from which a Supplement Health Belief score was calculated. Eligible non-respondents indicated their age, sex, and whether they had used a supplement within the past month. Similar proportions of participants (n = 969) and non-respondents (n = 1,027) reported any supplement use in the past month. Among participants, 60% had used a vitamin D supplement (median intake among supplement users was 10 microg/d) and 3% exceeded the Tolerable Upper Intake Level of 50 microg/d. In multivariate analysis, vitamin D supplementation was significantly associated with female sex, not smoking, higher educational attainment, having a health care professional recommend supplement use, and a higher Supplement Health Belief score. Although most older adults used a vitamin D supplement, further dissemination of this recommendation is needed.

Effect of herpes simplex suppression on incidence of HIV among women in Tanzania.

Infection with herpes simplex virus type 2 (HSV-2) is associated with an increased risk of acquiring infection with the human immunodeficiency virus (HIV). This study tested the hypothesis that HSV-2 suppressive therapy reduces the risk of HIV acquisition. Female workers at recreational facilities in northwestern Tanzania who were 16 to 35 years of age were interviewed and underwent serologic testing for HIV and HSV-2. We enrolled female workers who were HIV-seronegative and HSV-2-seropositive in a randomized, double-blind, placebo-controlled trial of suppressive treatment with acyclovir (400 mg twice daily). Participants attended mobile clinics every 3 months for a follow-up period of 12 to 30 months, depending on enrollment date. The primary outcome was the incidence of infection with HIV. We used a modified intention-to-treat analysis; data for participants who became pregnant were censored. Adherence to treatment was estimated by a tablet count at each visit. A total of 821 participants were randomly assigned to receive acyclovir (400 participants) or placebo (421 participants); 679 (83%) completed follow-up. Mean follow-up for the acyclovir and placebo groups was 1.52 and 1.62 years, respectively. The incidence of HIV infection was 4.27 per 100 person-years (27 participants in the acyclovir group and 28 in the placebo group), and there was no overall effect of acyclovir on the incidence of HIV (rate ratio for the acyclovir group, 1.08; 95% confidence interval, 0.64 to 1.83). The estimated median adherence was 90%. Genital HSV was detected in a similar proportion of participants in the two study groups at 6, 12, and 24 months. No serious adverse events were attributable to treatment with acyclovir. These data show no evidence that acyclovir (400 mg twice daily) as HSV suppressive therapy decreases the incidence of infection with HIV. (Current Controlled Trials number, ISRCTN35385041 [controlled-trials.com].).

Safety, Immunogenicity, and Immune Memory of a Novel Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (MCV-4) in Healthy Adolescents

A meningococcal (groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV-4; Menactra; Sanofi Pasteur Inc, Swiftwater, Pa) was developed to improve the profile of currently licensed products. The objective of this study was to compare the tolerability, immunogenicity, and immune memory of MCV-4 with those of a quadrivalent polysaccharide vaccine (PSV-4; Menomune A/C/Y/W-135; Sanofi Pasteur Inc). A randomized, double-blind trial was performed at 11 clinical centers in the United States. The vaccine MCV-4 or PSV-4 was administered to 881 healthy 11- to 18-year-olds. Sera were collected prevaccination and 28 days postvaccination. Three-year follow-up and booster vaccination with MCV-4 were performed in a participant subset from each group and a control group. Proportion of participants with a 4-fold or greater increase in serum bactericidal antibody against each serogroup 28 days after initial vaccination, geometric mean serum bactericidal antibody titers, and safety assessments. Both vaccines were well tolerated; most reactions were mild. More MCV-4 recipients reported solicited local reactions (68.9%) than PSV-4 recipients (30.2%). Both MCV-4 and PSV-4 were highly immunogenic; similar proportions of participants had 4-fold or greater increases in serum bactericidal antibody (range, 80.1%-96.7%) to the 4 serogroups. Three-year follow-up showed persistence of serum bactericidal antibody and booster responses to MCV-4 consistent with immune memory in participants previously vaccinated with MCV-4, but not in those who had previously received PSV-4. The vaccine MCV-4 was well tolerated and highly immunogenic. Persistence of bactericidal activity with MCV-4, but not PSV-4, was evident 3 years after the initial immunization. Booster response was demonstrated after a second vaccination with MCV-4.

Randomization in Controlled Clinical Trials: Why the Flip of a Coin Is So Important

The randomized controlled trial (RCT) is considered the highest level of medical evidence. In this brief overview, we discuss several key principles of the RCT. First, balance is paramount. Comparison groups must have similar proportions of participants with “important” prognostic and confounding factors. Randomization may or may not achieve this balance; if it does not, statistical adjustments should be used. Second, a statistical analysis should emphasize comparability and not mask dissimilarity. If the trial was indeed randomized, certain analysis techniques, such as an intention to treat analysis, should always be presented. Third, additional bias-reducing techniques, such as concealing treatment assignments from treating physicians and participants (i.e., masking) and using clearly defined exclusion and inclusion criteria, should be used wherever possible.