The face of equipoise - delivering a structured education programme within a randomized controlled trial: qualitative study

PubMed Central

2014-01-01

Background In trials of behavioural interventions, the individuals who deliver the intervention are in a position of key influence on the success of the trial. Their fidelity to the intervention is crucial. Yet little is understood about the experiences of this group of trial personnel. This study aimed to investigate the views and experiences of educators who delivered a structured education intervention to people with type 2 diabetes, which incorporated training in self-monitoring of either blood glucose (SMBG) or urine glucose (SMUG) as part of a randomized controlled trial (RCT). Methods Educators’ views were explored through focus groups before and after training (N = 18) and approximately 1 year into the trial (N = 14), and semi-structured telephone interviews at approximately 2 years (N = 7). Analysis was based on the constant comparative method. Results Educators held preferences regarding the intervention variants; thus, they were not in individual equipoise. Training raised awareness of preferences and their potential to impact on delivery. Educators were confident in their unbiased delivery, but acknowledged the challenges involved. Concealing their preferences was helped by a sense of professionalism, the patient-centred nature of the intervention, and concessions in the trial protocol (enabling participants to swap monitoring methods if needed). Commitment to unbiased delivery was explained through a desire for evidence-based knowledge in the contentious area of SMBG. Conclusions The findings provide insight into a previously unexplored group of trial personnel - intervention deliverers in trials of behavioural interventions - which will be useful to those designing and running similar trials. Rather than individual equipoise, it is intervention deliverers’ awareness of personal preferences and their potential impact on the trial outcome that facilitates unbiased delivery. Further, awareness of community equipoise, the need for evidence, and relevance to the individual enhance commitment to the RCT. Trial registration ISRCTN95696668 PMID:24405854

Randomized clinical trials and observational studies in the assessment of drug safety.

PubMed

Sawchik, J; Hamdani, J; Vanhaeverbeek, M

2018-05-01

Randomized clinical trials are considered as the preferred design to assess the potential causal relationships between drugs or other medical interventions and intended effects. For this reason, randomized clinical trials are generally the basis of development programs in the life cycle of drugs and the cornerstone of evidence-based medicine. Instead, randomized clinical trials are not the design of choice for the detection and assessment of rare, delayed and/or unexpected effects related to drug safety. Moreover, the highly homogeneous populations resulting from restrictive eligibility criteria make randomized clinical trials inappropriate to describe comprehensively the safety profile of drugs. In that context, observational studies have a key added value when evaluating the benefit-risk balance of the drugs. However, observational studies are more prone to bias than randomized clinical trials and they have to be designed, conducted and reported judiciously. In this article, we discuss the strengths and limitations of randomized clinical trials and of observational studies, more particularly regarding their contribution to the knowledge of medicines' safety profile. In addition, we present general recommendations for the sensible use of observational data. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Mixed-Meal Tolerance Test Versus Glucagon Stimulation Test for the Assessment of β-Cell Function in Therapeutic Trials in Type 1 Diabetes

PubMed Central

Greenbaum, Carla J.; Mandrup-Poulsen, Thomas; McGee, Paula Friedenberg; Battelino, Tadej; Haastert, Burkhard; Ludvigsson, Johnny; Pozzilli, Paolo; Lachin, John M.; Kolb, Hubert

2008-01-01

OBJECTIVE—β-Cell function in type 1 diabetes clinical trials is commonly measured by C-peptide response to a secretagogue in either a mixed-meal tolerance test (MMTT) or a glucagon stimulation test (GST). The Type 1 Diabetes TrialNet Research Group and the European C-peptide Trial (ECPT) Study Group conducted parallel randomized studies to compare the sensitivity, reproducibility, and tolerability of these procedures. RESEARCH DESIGN AND METHODS—In randomized sequences, 148 TrialNet subjects completed 549 tests with up to 2 MMTT and 2 GST tests on separate days, and 118 ECPT subjects completed 348 tests (up to 3 each) with either two MMTTs or two GSTs. RESULTS—Among individuals with up to 4 years’ duration of type 1 diabetes, >85% had measurable stimulated C-peptide values. The MMTT stimulus produced significantly higher concentrations of C-peptide than the GST. Whereas both tests were highly reproducible, the MMTT was significantly more so (R2 = 0.96 for peak C-peptide response). Overall, the majority of subjects preferred the MMTT, and there were few adverse events. Some older subjects preferred the shorter duration of the GST. Nausea was reported in the majority of GST studies, particularly in the young age-group. CONCLUSIONS—The MMTT is preferred for the assessment of β-cell function in therapeutic trials in type 1 diabetes. PMID:18628574

Mixed-meal tolerance test versus glucagon stimulation test for the assessment of beta-cell function in therapeutic trials in type 1 diabetes.

PubMed

Greenbaum, Carla J; Mandrup-Poulsen, Thomas; McGee, Paula Friedenberg; Battelino, Tadej; Haastert, Burkhard; Ludvigsson, Johnny; Pozzilli, Paolo; Lachin, John M; Kolb, Hubert

2008-10-01

Beta-cell function in type 1 diabetes clinical trials is commonly measured by C-peptide response to a secretagogue in either a mixed-meal tolerance test (MMTT) or a glucagon stimulation test (GST). The Type 1 Diabetes TrialNet Research Group and the European C-peptide Trial (ECPT) Study Group conducted parallel randomized studies to compare the sensitivity, reproducibility, and tolerability of these procedures. In randomized sequences, 148 TrialNet subjects completed 549 tests with up to 2 MMTT and 2 GST tests on separate days, and 118 ECPT subjects completed 348 tests (up to 3 each) with either two MMTTs or two GSTs. Among individuals with up to 4 years' duration of type 1 diabetes, >85% had measurable stimulated C-peptide values. The MMTT stimulus produced significantly higher concentrations of C-peptide than the GST. Whereas both tests were highly reproducible, the MMTT was significantly more so (R(2) = 0.96 for peak C-peptide response). Overall, the majority of subjects preferred the MMTT, and there were few adverse events. Some older subjects preferred the shorter duration of the GST. Nausea was reported in the majority of GST studies, particularly in the young age-group. The MMTT is preferred for the assessment of beta-cell function in therapeutic trials in type 1 diabetes.

Influence of unhealthy food and beverage marketing on children's dietary intake and preference: a systematic review and meta-analysis of randomized trials.

PubMed

Sadeghirad, B; Duhaney, T; Motaghipisheh, S; Campbell, N R C; Johnston, B C

2016-10-01

Marketing of foods and beverages high in fat, sugar and salt are suggested to contribute to poor dietary behaviours in children and diet-related diseases later in life. This systematic review and meta-analysis of randomized trials aimed to assess the effects of unhealthy food and beverage marketing on dietary intake (grams or kilocalories) and dietary preference (preference score or percentage of participants who selected specific foods/beverages) among children 2 to 18 years of age. We searched MEDLINE, EMBASE and PsycINFO up to January 2015 for terms related to advertising, unhealthy foods or beverages among children. Randomized trials that assessed the effects of unhealthy food and beverage marketing compared with non-dietary advertisement or no advertisement in children were considered eligible. Two authors independently extracted information on study characteristics and outcomes of interest and assessed risk of bias and the overall quality of evidence using grade methodology. Meta-analysis was conducted separately for dietary intake and preference using a random-effects model. We identified 29 eligible studies, of which 17 studies were included for meta-analysis of dietary preference and nine for meta-analysis of dietary intake. Almost half of the studies were at high risk of bias. Our meta-analysis showed that in children exposed to unhealthy dietary marketing, dietary intake significantly increased (mean difference [MD] = 30.4 kcal, 95% confidence interval [CI] 2.9 to 57.9, and MD = 4.8 g, 95%CI 0.8 to 8.8) during or shortly after exposure to advertisements. Similarly, children exposed to the unhealthy dietary marketing had a higher risk of selecting the advertised foods or beverages (relative risk = 1.1, 95%CI 1.0 to 1.2; P = 0.052). The evidence indicates that unhealthy food and beverage marketing increases dietary intake (moderate quality evidence) and preference (moderate to low quality evidence) for energy-dense, low-nutrition food and beverage. Unhealthy food and beverage marketing increased dietary intake and influenced dietary preference in children during or shortly after exposure to advertisements. © 2016 World Obesity. © 2016 World Obesity.

On Measuring and Reducing Selection Bias with a Quasi-Doubly Randomized Preference Trial

ERIC Educational Resources Information Center

Joyce, Ted; Remler, Dahlia K.; Jaeger, David A.; Altindag, Onur; O'Connell, Stephen D.; Crockett, Sean

2017-01-01

Randomized experiments provide unbiased estimates of treatment effects, but are costly and time consuming. We demonstrate how a randomized experiment can be leveraged to measure selection bias by conducting a subsequent observational study that is identical in every way except that subjects choose their treatment--a quasi-doubly randomized…

Nurse-Moderated Internet-Based Support for New Mothers: Non-Inferiority, Randomized Controlled Trial

PubMed Central

Reece, Christy E; Bowering, Kerrie; Jeffs, Debra; Sawyer, Alyssa C P; Mittinty, Murthy; Lynch, John W

2017-01-01

Background Internet-based interventions moderated by community nurses have the potential to improve support offered to new mothers, many of whom now make extensive use of the Internet to obtain information about infant care. However, evidence from population-based randomized controlled trials is lacking. Objective The aim of this study was to test the non-inferiority of outcomes for mothers and infants who received a clinic-based postnatal health check plus nurse-moderated, Internet-based group support when infants were aged 1-7 months as compared with outcomes for those who received standard care consisting of postnatal home-based support provided by a community nurse. Methods The design of the study was a pragmatic, preference, non-inferiority randomized control trial. Participants were recruited from mothers contacted for their postnatal health check, which is offered to all mothers in South Australia. Mothers were assigned either (1) on the basis of their preference to clinic+Internet or home-based support groups (n=328), or (2) randomly assigned to clinic+Internet or home-based groups if they declared no strong preference (n=491). The overall response rate was 44.8% (819/1827). The primary outcome was parenting self-competence, as measured by the Parenting Stress Index (PSI) Competence subscale, and the Karitane Parenting Confidence Scale scores. Secondary outcome measures included PSI Isolation, Interpersonal Support Evaluation List–Short Form, Maternal Support Scale, Ages and Stages Questionnaire–Social-Emotional and MacArthur Communicative Development Inventory (MCDI) scores. Assessments were completed offline via self-assessment questionnaires at enrolment (mean child age=4.1 weeks, SD 1.3) and again when infants were aged 9, 15, and 21 months. Results Generalized estimating equations adjusting for post-randomization baseline imbalances showed that differences in outcomes between mothers in the clinic+Internet and home-based support groups did not exceed the pre-specified margin of inferiority (0.25 of a SD) on any outcome measure at any follow-up assessment, with the exception of MCDI scores assessing children’s language development at 21 months for randomized mothers, and PSI Isolation scores at 9 months for preference mothers. Conclusion Maternal and child outcomes from a clinic-based postnatal health check plus nurse-moderated Internet-based support were not inferior to those achieved by a universal home-based postnatal support program. Postnatal maternal and infant support using the Internet is a promising alternative to home-based universal support programs. Trial Registration Australian New Zealand Clinical Trials Registry Number (ANZCTR): ACTRN12613000204741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363712&isReview=true (Archived by WebCite at http://www.webcitation.org/6rZeCJ3k1) PMID:28739559

Three lessons from a randomized trial of massage and meditation at end of life: patient benefit, outcome measure selection, and design of trials with terminally ill patients.

PubMed

Downey, Lois; Engelberg, Ruth A; Standish, Leanna J; Kozak, Leila; Lafferty, William E

2009-01-01

Improving end-of-life care is a priority in the United States, but assigning priorities for standard care services requires evaluations using appropriate study design and appropriate outcome indicators. A recent randomized controlled trial with terminally ill patients produced no evidence of benefit from massage or guided meditation, when evaluated with measures of global quality of life or pain distress over the course of patient participation. However, reanalysis using a more targeted outcome, surrogates' assessment of patients' benefit from the study intervention, suggested significant gains from massage-the treatment patients gave their highest preassignment preference ratings. The authors conclude that adding a menu of complementary therapies as part of standard end-of-life care may yield significant benefit, that patient preference is an important predictor of outcome, and that modifications in trial design may be appropriate for end-of-life studies.

A randomized controlled trial of cast versus splint for distal radial buckle fracture: an evaluation of satisfaction, convenience, and preference.

PubMed

Williams, Kristine G; Smith, Gillian; Luhmann, Scott J; Mao, Jingnan; Gunn, Joseph D; Luhmann, Janet D

2013-05-01

Buckle fractures are inherently stable and at low risk for displacement. These advantages allow for treatment options that may create confusion for the practitioner. Accepted immobilization methods include circumferential cast, plaster or prefabricated splint, and soft bandaging. Despite mounting evidence for splinting, the questions of pain, preference, satisfaction, and convenience offer a challenge to changing practice. The purposes of this study were (1) to compare cast versus splint for distal radial buckle fractures in terms of parental and patient satisfaction, convenience, and preference and (2) to compare pain reported for cast versus splint. We conducted a prospective randomized trial of a convenience sample of patients 2 through 17 years with a radiologically confirmed distal radial buckle fracture. Subjects were randomly assigned to short-arm cast or prefabricated wrist splint. We assessed satisfaction, convenience, preference, and pain in the emergency department and at days 1, 3, 7, and 21 after immobilization. Ninety-four patients were enrolled. Compared with the cast group, those in the splint group reported higher levels of satisfaction, preference, and convenience on 10-point visual analog scale. Although pain scores were higher for those in the splint group, the difference was not statistically significant. With the exception of pain reported in the emergency department being higher for the splinted group, all other measures, including convenience, satisfaction, and preference, showed a clear trend favoring splints at almost every time period in the study. This study provides additional evidence that splinting is preferable to casting for the treatment of distal radial buckle fractures.

Use of Video to Facilitate End-of-Life Discussions With Patients With Cancer: A Randomized Controlled Trial

PubMed Central

El-Jawahri, Areej; Podgurski, Lisa M.; Eichler, April F.; Plotkin, Scott R.; Temel, Jennifer S.; Mitchell, Susan L.; Chang, Yuchiao; Barry, Michael J.; Volandes, Angelo E.

2010-01-01

Purpose To determine whether the use of a goals-of-care video to supplement a verbal description can improve end-of-life decision making for patients with cancer. Methods Fifty participants with malignant glioma were randomly assigned to either a verbal narrative of goals-of-care options at the end of life (control), or a video after the same verbal narrative (intervention) in this randomized controlled trial. The video depicts three levels of medical care: life-prolonging care (cardiopulmonary resuscitation [CPR], ventilation), basic care (hospitalization, no CPR), and comfort care (symptom relief). The primary study outcome was participants' preferences for end-of-life care. The secondary outcome was participants' uncertainty regarding decision making (score range, 3 to 15; higher score indicating less uncertainty). Participants' comfort level with the video was also measured. Results Fifty participants were randomly assigned to either the verbal narrative (n = 27) or video (n = 23). After the verbal description, 25.9% of participants preferred life-prolonging care, 51.9% basic care, and 22.2% comfort care. In the video arm, no participants preferred life-prolonging care, 4.4% preferred basic care, 91.3% preferred comfort care, and 4.4% were uncertain (P < .0001). The mean uncertainty score was higher in the video group than in the verbal group (13.7 v 11.5, respectively; P < .002). In the intervention arm, 82.6% of participants reported being very comfortable watching the video. Conclusion Compared with participants who only heard a verbal description, participants who viewed a goals-of-care video were more likely to prefer comfort care and avoid CPR, and were more certain of their end-of-life decision making. Participants reported feeling comfortable watching the video. PMID:19949010

Methodological Foundations for the Empirical Evaluation of Non-Experimental Methods in Field Settings

ERIC Educational Resources Information Center

Wong, Vivian C.; Steiner, Peter M.

2015-01-01

Across the disciplines of economics, political science, public policy, and now, education, the randomized controlled trial (RCT) is the preferred methodology for establishing causal inference about program impacts. But randomized experiments are not always feasible because of ethical, political, and/or practical considerations, so non-experimental…

A randomized controlled trial comparing McKenzie therapy and motor control exercises on the recruitment of trunk muscles in people with chronic low back pain: a trial protocol.

PubMed

Halliday, Mark H; Ferreira, Paulo H; Hancock, Mark J; Clare, Helen A

2015-06-01

To investigate if McKenzie exercises when applied to a cohort of patients with chronic LBP who have a directional preference demonstrate improved recruitment of the transversus abdominis compared to motor control exercises when measurements were assessed from ultrasound images. A randomized blinded trial with a 12-month follow-up. The Physiotherapy department of Concord Hospital a primary health care environment. 70-adults with greater than three-month history of LBP who have a directional preference. McKenzie techniques or motor control exercises for 12-sessions over eight weeks. Transversus abdominus thickness measured from real time ultrasound images, pain, global perceived effect and capacity to self-manage. This study will be the first to investigate the possible mechanism of action that McKenzie therapy and motor control exercises have on the recruitment of the transversus abdominus in a cohort of low back pain patients sub-classified with a directional preference. Patients receiving matched exercises according to their directional preference are believed to have better outcomes than those receiving unmatched exercises. A better understanding of the mechanism of action that specific treatments such as motor control exercises or McKenzie exercises have on patients classified with a directional preference will allow therapist to make a more informed choice about treatment options. Copyright © 2014 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Lay public's understanding of equipoise and randomisation in randomised controlled trials.

PubMed

Robinson, E J; Kerr, C E P; Stevens, A J; Lilford, R J; Braunholtz, D A; Edwards, S J; Beck, S R; Rowley, M G

2005-03-01

To research the lay public's understanding of equipoise and randomisation in randomised controlled trials (RCTs) and to look at why information on this may not be not taken in or remembered, as well as the effects of providing information designed to overcome barriers. Investigations were informed by an update of systematic review on patients' understanding of consent information in clinical trials, and by relevant theory and evidence from experimental psychology. Nine investigations were conducted with nine participants. Access (return to education), leisure and vocational courses at Further Education Colleges in the Midlands, UK. Healthy adults with a wide range of educational backgrounds and ages. Participants read hypothetical scenarios and wrote brief answers to subsequent questions. Sub-samples of participants were interviewed individually to elaborate on their written answers. Participants' background assumptions concerning equipoise and randomisation were examined and ways of helping participants recognise the scientific benefits of randomisation were explored. Judgments on allocation methods; treatment preferences; the acceptability of random allocation; whether or not individual doctors could be completely unsure about the best treatment; whether or not doctors should reveal treatment preferences under conditions of collective equipoise; and how sure experts would be about the best treatment following random allocation vs doctor/patient choice. Assessments of understanding hypothetical trial information. Recent literature continues to report trial participants' failure to understand or remember information about randomisation and equipoise, despite the provision of clear and readable trial information leaflets. In current best practice, written trial information describes what will happen without offering accessible explanations. As a consequence, patients may create their own incorrect interpretations and consent or refusal may be inadequately informed. In six investigations, most participants identified which methods of allocation were random, but judged the random allocation methods to be unacceptable in a trial context; the mere description of a treatment as new was insufficient to engender a preference for it over a standard treatment; around half of the participants denied that a doctor could be completely unsure about the best treatment. A majority of participants judged it unacceptable for a doctor to suggest letting chance decide when uncertain of the best treatment, and, in the absence of a justification for random allocation, participants did not recognise scientific benefits of random allocation over normal treatment allocation methods. The pattern of results across three intervention studies suggests that merely supplementing written trial information with an explanation is unlikely to be helpful. However, when people manage to focus on the trial's aim of increasing knowledge (as opposed to making treatment decisions about individuals), and process an explanation actively, they may be helped to understand the scientific reasons for random allocation. This research was not carried out in real healthcare settings. However, participants who could correctly identify random allocation methods, yet judged random allocation unacceptable, doubted the possibility of individual equipoise and saw no scientific benefits of random allocation over doctor/patient choice, are unlikely to draw upon contrasting views if invited to enter a real clinical trial. This suggests that many potential trial participants may have difficulty understanding and remembering trial information that conforms to current best practice in its descriptions of randomisation and equipoise. Given the extent of the disparity between the assumptions underlying trial design and the assumptions held by the lay public, the solution is unlikely to be simple. Nevertheless, the results suggest that including an accessible explanation of the scientific benefits of randomisation may be beneficial provided potential participants are also enabled to reflect on the trial's aim of advancing knowledge, and to think actively about the information presented. Further areas for consideration include: the identification of effective combinations of written and oral information; helping participants to reflect on the aim of advancing knowledge; and an evidence-based approach to leaflet construction.

Randomised clinical trials with clinician-preferred treatment.

PubMed

Korn, E L; Baumrind, S

1991-01-19

The standard design for randomised clinical trials may be inappropriate when the clinician believes that one of the treatments being tested is superior for the patient, or when the clinician has a preference for one of the treatments. For such instances the suggestion is that the patient is randomly allocated to treatment only when there is clinical disagreement about treatment of choice for that patient, and then the patient is assigned to a clinician who had thought that the regimen allocated is the one most appropriate for that patient.

Not seeking yet trying long-acting reversible contraception: a 24-month randomized trial on continuation, unintended pregnancy and satisfaction.

PubMed

Hubacher, David; Spector, Hannah; Monteith, Charles; Chen, Pai-Lien

2018-06-01

To measure the 24-month impact on continuation, unintended pregnancy and satisfaction of trying long-acting reversible contraception (LARC) in a population seeking short-acting reversible contraception (SARC). We enrolled 916 women aged 18-29 who were seeking pills or injectables in a partially randomized patient preference trial. Women with strong preferences for pills or injectables started on those products, while others opted for randomization to LARC or SARC and received their methods gratis. We estimated continuation and unintended pregnancy rates through 24months. Intent-to-treat principles were applied after method initiation for comparing incidence of unintended pregnancy. We also examined how satisfaction levels varied by cohort and how baseline negative LARC attitudes were associated with satisfaction over time. Forty-three percent chose randomization, and 57% chose the preference option. Complete loss to follow-up was<2%. The 24-month LARC continuation probability was 64.3% [95% confidence interval (CI): 56.6-70.9], statistically higher than SARC groups [25.5% (randomized) and 40.0% (preference)]. The 24-month cumulative unintended pregnancy probabilities were 9.9% (95% CI: 7.2-12.6) (preference-SARC), 6.9% (95% CI: 3.3-10.6) (randomized-SARC) and 3.6% (95% CI: 1.8-6.4) (randomized-LARC). Statistical tests for comparing randomized groups on unintended pregnancy were mixed: binomial at 24-month time point (p=.02) and log-rank survival probabilities (p=.14 for first pregnancies and p=.07 when including second pregnancies). LARC satisfaction was high (80% happy/neutral, 73% would use LARC again, 81% would recommend to a friend). Baseline negative attitudes toward LARC (27%) were not clearly associated with satisfaction or early discontinuation. The decision to try LARC resulted in high continuation rates and substantial protection from unintended pregnancy over 24months. Despite participants' initial desires to begin short-acting regimens, they had high satisfaction with LARC. Voluntary decisions to try LARC will benefit large proportions of typical SARC users. Even women who do not necessarily view LARC as a first choice may have a highly satisfying experience and avoid unintended pregnancy if they try it. Copyright © 2018 Elsevier Inc. All rights reserved.

Patient-centered clinical trials.

PubMed

Chaudhuri, Shomesh E; Ho, Martin P; Irony, Telba; Sheldon, Murray; Lo, Andrew W

2018-02-01

We apply Bayesian decision analysis (BDA) to incorporate patient preferences in the regulatory approval process for new therapies. By assigning weights to type I and type II errors based on patient preferences, the significance level (α) and power (1-β) of a randomized clinical trial (RCT) for a new therapy can be optimized to maximize the value to current and future patients and, consequently, to public health. We find that for weight-loss devices, potentially effective low-risk treatments have optimal αs larger than the traditional one-sided significance level of 5%, whereas potentially less effective and riskier treatments have optimal αs below 5%. Moreover, the optimal RCT design, including trial size, varies with the risk aversion and time-to-access preferences and the medical need of the target population. Copyright © 2017 Elsevier Ltd. All rights reserved.

Rationale and baseline characteristics of PREVENT: a second-generation intervention trial in subjects at-risk (prodromal) of developing first-episode psychosis evaluating cognitive behavior therapy, aripiprazole, and placebo for the prevention of psychosis.

PubMed

Bechdolf, Andreas; Müller, Hendrik; Stützer, Hartmut; Wagner, Michael; Maier, Wolfgang; Lautenschlager, Marion; Heinz, Andreas; de Millas, Walter; Janssen, Birgit; Gaebel, Wolfgang; Michel, Tanja Maria; Schneider, Frank; Lambert, Martin; Naber, Dieter; Brüne, Martin; Krüger-Özgürdal, Seza; Wobrock, Thomas; Riedel, Michael; Klosterkötter, Joachim

2011-09-01

Antipsychotics, cognitive behavioral therapy (CBT), and omega-3-fatty acids have been found superior to control conditions as regards prevention of psychosis in people at-risk of first-episode psychosis. However, no large-scale trial evaluating the differential efficacy of CBT and antipsychotics has been performed yet. In PREVENT, we evaluate CBT, aripiprazole, and clinical management (CM) as well as placebo and CM for the prevention of psychosis in a randomized, double-blind, placebo-controlled trial with regard to the antipsychotic intervention and a randomized controlled trial with regard to the CBT intervention with blinded ratings. The hypotheses are first that CBT and aripiprazole and CM are superior to placebo and CM and second that CBT is not inferior to aripiprazole and CM combined. The primary outcome is transition to psychosis. By November 2010, 156 patients were recruited into the trial. The subjects were substantially functionally compromised (Social and Occupational Functioning Assessment Scale mean score 52.5) and 78.3% presented with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition axis I comorbid diagnosis. Prior to randomization, 51.5% of the participants preferred to be randomized into the CBT arm, whereas only 12.9% preferred pharmacological treatment. First, assessments of audiotaped treatment sessions confirmed the application of CBT-specific skills in the CBT condition and the absence of those in CM. The overall quality rating of the CBT techniques applied in the CBT condition was good. When the final results of the trial are available, PREVENT will substantially expand the current limited evidence base for best clinical practice in people at-risk (prodromal) of first-episode psychosis.

Experiences of being a control group: lessons from a UK-based randomized controlled trial of group singing as a health promotion initiative for older people.

PubMed

Skingley, Ann; Bungay, Hilary; Clift, Stephen; Warden, June

2014-12-01

Existing randomized controlled trials within the health field suggest that the concept of randomization is not always well understood and that feelings of disappointment may occur when participants are not placed in their preferred arm. This may affect a study's rigour and ethical integrity if not addressed. We aimed to test whether these issues apply to a healthy volunteer sample within a health promotion trial of singing for older people. Written comments from control group participants at two points during the trial were analysed, together with individual semi-structured interviews with a small sample (n = 11) of this group. We found that motivation to participate in the trial was largely due to the appeal of singing and disappointment resulted from allocation to the control group. Understanding of randomization was generally good and feelings of disappointment lessened over time and with a post-research opportunity to sing. Findings suggest that measures should be put in place to minimize the potential negative impacts of randomized controlled trials in health promotion research. © The Author (2013). Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Tailoring mind-body therapies to individual needs: patients' program preference and psychological traits as moderators of the effects of mindfulness-based cancer recovery and supportive-expressive therapy in distressed breast cancer survivors.

PubMed

Carlson, Linda E; Tamagawa, Rie; Stephen, Joanne; Doll, Richard; Faris, Peter; Dirkse, Dale; Speca, Michael

2014-11-01

Mindfulness-based cancer recovery (MBCR) and supportive-expressive therapy (SET) are well-validated psycho-oncological interventions, and we have previously reported health benefits of both programs. However, little is known about patients' characteristics or program preferences that may influence outcomes. Therefore, this study examined moderators of the effects of MBCR and SET on psychological well-being among breast cancer survivors. A multi-site randomized controlled trial was conducted between 2007 and 2012 in two Canadian cities (Calgary and Vancouver). A total of 271 distressed stage I-III breast cancer survivors were randomized into MBCR, SET or a 1-day stress management seminar (SMS). Baseline measures of moderator variables included program preference, personality traits, emotional suppression, and repressive coping. Outcome measures of mood, stress symptoms, quality of life, spiritual well-being, post-traumatic growth, social support, and salivary cortisol were measured pre- and post intervention. Hierarchical regression analyses were used to assess moderator effects on outcomes. The most preferred program was MBCR (55%). Those who were randomized to their preference improved more over time on quality of life and spiritual well-being post-intervention regardless of the actual intervention type received. Women with greater psychological morbidity at baseline showed greater improvement in stress symptoms and quality of life if they received their preferred versus nonpreferred program. Patients' program preference and baseline psychological functioning, rather than personality, were predictive of program benefits. These results suggest incorporating program preference can maximize the efficacy of integrative oncology interventions, and emphasize the methodological importance of assessing and accommodating for preferences when conducting mind-body clinical trials. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Dental Students' Perceptions of Digital and Conventional Impression Techniques: A Randomized Controlled Trial.

PubMed

Zitzmann, Nicola U; Kovaltschuk, Irina; Lenherr, Patrik; Dedem, Philipp; Joda, Tim

2017-10-01

The aim of this randomized controlled trial was to analyze inexperienced dental students' perceptions of the difficulty and applicability of digital and conventional implant impressions and their preferences including performance. Fifty undergraduate dental students at a dental school in Switzerland were randomly divided into two groups (2×25). Group A first took digital impressions in a standardized phantom model and then conventional impressions, while the procedures were reversed for Group B. Participants were asked to complete a VAS questionnaire (0-100) on the level of difficulty and applicability (user/patient-friendliness) of both techniques. They were asked which technique they preferred and perceived to be more efficient. A quotient of "effective scan time per software-recorded time" (TRIOS) was calculated as an objective quality indicator for intraoral optical scanning (IOS). The majority of students perceived IOS as easier than the conventional technique. Most (72%) preferred the digital approach using IOS to take the implant impression to the conventional method (12%) or had no preference (12%). Although total work was similar for males and females, the TRIOS quotient indicated that male students tended to use their time more efficiently. In this study, dental students with no clinical experience were very capable of acquiring digital tools, indicating that digital impression techniques can be included early in the dental curriculum to help them catch up with ongoing development in computer-assisted technologies used in oral rehabilitation.

Framing Options as Choice or Opportunity: Does the Frame Influence Decisions?

PubMed

Abhyankar, Purva; Summers, Barbara A; Velikova, Galina; Bekker, Hilary L

2014-07-01

Health professionals must enable patients to make informed decisions about health care choices through unbiased presentation of all options. This study examined whether presenting the decision as "opportunity" rather than "choice" biased individuals' preferences in the context of trial participation for cancer treatment. Self-selecting healthy women (N = 124) were randomly assigned to the following decision frames: opportunity to take part in the trial (opt-in), opportunity to be removed from the trial (opt-out), and choice to have standard treatment or take part in the trial (choice). The computer-based task required women to make a hypothetical choice about a real-world cancer treatment trial. The software presented the framed scenario, recorded initial preference, presented comprehensive and balanced information, traced participants' use of information during decision making, and recorded final decision. A posttask paper questionnaire assessed perceived risk, attitudes, subjective norm, perceived behavioral control, and satisfaction with decision. Framing influenced women's immediate preferences. Opportunity frames, whether opt-in or opt-out, introduced a bias as they discouraged women from choosing standard treatment. Using the choice frame avoided this bias. The opt-out opportunity frame also affected women's perceived social norm; women felt that others endorsed the trial option. The framing bias was not present once participants had had the opportunity to view detailed information on the options within a patient decision aid format. There were no group differences in information acquisition and final decisions. Sixteen percent changed their initial preference after receiving full information. A "choice" frame, where all treatment options are explicit, is less likely to bias preferences. Presentation of full information in parallel, option-by-attribute format is likely to "de-bias" the decision frame. Tailoring of information to initial preferences would be ill-advised as preferences may change following detailed information. © The Author(s) 2014.

Exploring Women's Preferences for the Mode of Delivery in Twin Gestations: Results of the Twin Birth Study.

PubMed

Murray-Davis, Beth; McVittie, Jennifer; Barrett, Jon F; Hutton, Eileen K

2016-12-01

The Twin Birth Study, an international, multi-center randomized controlled trial was conducted to compare the risks of planned cesarean with planned vaginal delivery for twin pregnancies. The aim of this component of the trial was to understand participants' perspectives of study participation and preferences for the mode of delivery. A mixed-methods questionnaire was distributed to study participants 3 months after giving birth. The questionnaire contained Likert scales and open-ended questions about the experience of being enrolled in a clinical trial and of childbirth, including the mode of delivery. Quantitative data were analyzed using SAS to generate descriptive statistics. Qualitative data were analyzed to identify categories and themes. Ninety-one percent of trial participants completed the questionnaire. Across all groups, the majority of women would participate in a study like this one again if given the opportunity. Main benefits of participating were as follows: benefits to one and one's babies, altruism, and receiving quality care. Randomization for the mode of delivery was challenging for women because of the desire to be involved in decision-making. Findings related to childbirth experience and the mode of delivery demonstrated a preference for vaginal birth across all groups. Those who had a vaginal birth were more satisfied with their birth experience. This study provides evidence to inform practitioners about what women who have twin pregnancies like or dislike about birth and their desire for involvement in decision-making. Vaginal birth was preferred across all study groups and was associated with greater satisfaction with childbirth experience. © 2016 Wiley Periodicals, Inc.

Chlorambucil for the treatment of patients with chronic lymphocytic leukemia (CLL) - a systematic review and meta-analysis of randomized trials.

PubMed

Vidal, Liat; Gurion, Ronit; Ram, Ron; Raanani, Pia; Bairey, Osnat; Robak, Tadeusz; Gafter-Gvili, Anat; Shpilberg, Ofer

2016-09-01

Randomized clinical trials that compared chlorambucil to different regimens, for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) do not support an overall survival (OS) benefit. To assess the efficacy and safety of chlorambucil as frontline treatment, we conducted a systematic review and meta-analysis of randomized controlled trials. OS was the primary outcome. Meta-analysis of 18 trials that compared purine analogs, alkylators, alemtuzumab and ibrutinib to chlorambucil demonstrated no OS benefit for therapy without chlorambucil over chlorambucil (pooled HR 0.99, 95% CI 0.91-1.08; 4133 patients). PFS was longer with purine analogs compared with chlorambucil with an increased risk of infection. The risk of secondary malignancies was not increased with chlorambucil. In conclusion, our study showed that chlorambucil is an acceptable chemotherapy backbone for unfit patients with CLL. Purine analogs should be preferred in fit younger patients because of longer PFS. Future trials should focus on unfit patients who are underrepresented in clinical trials.

The Effects of Constant versus Varied Reinforcers on Preference and Resistance to Change

ERIC Educational Resources Information Center

Milo, Jessie-Sue; Mace, F. Charles; Nevin, John A.

2010-01-01

Previous research has demonstrated that factors such as reinforcer frequency, amount, and delay have similar effects on resistance to change and preference. In the present study, 4 boys with autism made choices between a constant reinforcer (one that was the same food item every trial) and a varied food reinforcer (one that varied randomly between…

Hospital cost analysis of a prospective, randomized trial of early vs interval appendectomy for perforated appendicitis in children.

PubMed

Myers, Adrianne L; Williams, Regan F; Giles, Kim; Waters, Teresa M; Eubanks, James W; Hixson, S Douglas; Huang, Eunice Y; Langham, Max R; Blakely, Martin L

2012-04-01

The methods of surgical care for children with perforated appendicitis are controversial. Some surgeons prefer early appendectomy; others prefer initial nonoperative management followed by interval appendectomy. Determining which of these two therapies is most cost-effective was the goal of this study. We conducted a prospective, randomized trial in children with a preoperative diagnosis of perforated appendicitis. Patients were randomized to early or interval appendectomy. Overall hospital costs were extracted from the hospital's internal cost accounting system and the two treatment groups were compared using an intention-to-treat analysis. Nonparametric data were reported as median ± standard deviation (or range) and compared using a Wilcoxon rank sum test. One hundred thirty-one patients were randomized to either early (n = 64) or interval (n = 67) appendectomy. Hospital charges and costs were significantly lower in patients randomized to early appendectomy. Total median hospital costs were $17,450 (range $7,020 to $55,993) for patients treated with early appendectomy vs $22,518 (range $4,722 to $135,338) for those in the interval appendectomy group. Median hospital costs more than doubled in patients who experienced an adverse event ($15,245 vs $35,391, p < 0.0001). Unplanned readmissions also increased costs significantly and were more frequent in patients randomized to interval appendectomy. In a prospective randomized trial, hospital charges and costs were significantly lower for early appendectomy when compared with interval appendectomy. The increased costs were related primarily to the significant increase in adverse events, including unplanned readmissions, seen in the interval appendectomy group. Copyright © 2012. Published by Elsevier Inc.

Racial Variation in Treatment Preferences and Willingness to Randomize in the Spine Patient Outcomes Research Trial (SPORT)

PubMed Central

Arega, Addisalem; Birkmeyer, Nancy J. O.; Lurie, Jon D. N.; Tosteson, Tor; Gibson, Jennifer; Taylor, Brett; Weinstein, James N.

2009-01-01

Study Design Analysis of baseline data for patients enrolled in SPORT, a project conducting three randomized and three observational cohort studies of surgical and non-operative treatments for intervertebral disc herniation (IDH), spinal stenosis (SpS), and degenerative spondylolisthesis (DS). Objective To explore racial variation in treatment preferences and willingness to be randomized. Summary of Background Data Increasing minority participation in research has been a priority at the NIH. Prior studies have documented lower rates of participation in research and preferences for invasive treatment among African Americans. Methods Patients enrolled in SPORT (March 2000-February 2005) that reported data on their race (n=2323) were classified as White (87%), Black (8%) or Other (5%). Treatment preferences (non-operative, unsure, surgical), and willingness to be randomized were compared among these groups while controlling for baseline differences using multivariate logistic regression. Results There were numerous significant differences in baseline characteristics among the racial groups. Following adjustment for these differences, Blacks remained less likely to prefer surgical treatment among both IDH (White: 55%, Black: 37%, Other: 55%, p=0.023) and SpS/DS (White: 46%, Black: 30%, Other: 43%, p=0.017) patients. Higher randomization rates among Black IDH patients (46% vs. 30%) were no longer significant following adjustment (OR=1.45, p=0.235). Treatment preference remained a strong independent predictor of randomization in multivariate analyses for both IDH (unsure OR = 3.88, p<0.001 and surgical OR=0.23, p<0.001) and SpS/DS (unsure OR = 6.93, p<0.001 and surgical OR= 0.45, p<0.001) patients. Conclusions Similar to prior studies, Black participants were less likely than Whites or Others to prefer surgical treatment; however, they were no less likely to agree to be randomized. Treatment preferences were strongly related to both race and willingness to be randomized. PMID:16946665

Cyclophosphamide and Nandrolone Decanoate in the Treatment of Advanced Carcinoma of the Breast—Results of a Comparative Controlled Trial of the Agents Used Singly and in Combination

PubMed Central

Cole, M. P.; Todd, I. D. H.; Wilkinson, P. M.

1973-01-01

A random trial in which cyclophosphamide, nandrolone decanoate and the two drugs in combination were used in the treatment of advanced breast carcinoma is described. The results suggest that it is preferable to use cyclophosphamide on its own. PMID:4576562

Risk Stratification and Shared Decision Making for Colorectal Cancer Screening: A Randomized Controlled Trial.

PubMed

Schroy, Paul C; Duhovic, Emir; Chen, Clara A; Heeren, Timothy C; Lopez, William; Apodaca, Danielle L; Wong, John B

2016-05-01

Eliciting patient preferences within the context of shared decision making has been advocated for colorectal cancer (CRC) screening, yet providers often fail to comply with patient preferences that differ from their own. To determine whether risk stratification for advanced colorectal neoplasia (ACN) influences provider willingness to comply with patient preferences when selecting a desired CRC screening option. Randomized controlled trial. Asymptomatic, average-risk patients due for CRC screening in an urban safety net health care setting. Patients were randomized 1:1 to a decision aid alone (n= 168) or decision aid plus risk assessment (n= 173) arm between September 2012 and September 2014. The primary outcome was concordance between patient preference and test ordered; secondary outcomes included patient satisfaction with the decision-making process, screening intentions, test completion rates, and provider satisfaction. Although providers perceived risk stratification to be useful in selecting an appropriate screening test for their average-risk patients, no significant differences in concordance were observed between the decision aid alone and decision aid plus risk assessment groups (88.1% v. 85.0%,P= 0.40) or high- and low-risk groups (84.5% v. 87.1%,P= 0.51). Concordance was highest for colonoscopy and relatively low for tests other than colonoscopy, regardless of study arm or risk group. Failure to comply with patient preferences was negatively associated with satisfaction with the decision-making process, screening intentions, and test completion rates. Single-institution setting; lack of provider education about the utility of risk stratification into their decision making. Providers perceived risk stratification to be useful in their decision making but often failed to comply with patient preferences for tests other than colonoscopy, even among those deemed to be at low risk of ACN. © The Author(s) 2016.

Preference and Expectation for Treatment Assignment in a Randomized Controlled Trial of Once- vs Twice-weekly Yoga for Chronic Low Back Pain

PubMed Central

Weinberg, Janice; Sherman, Karen J.; Saper, Robert B.

2015-01-01

Background: In studies involving nonpharmacological complementary and alternative medicine interventions, participant blinding is very difficult. Participant expectations may affect perceived benefit of therapy. In studies of yoga as treatment for chronic low back pain, little is known about the relationship between patient expectations and preferences on outcomes. This study was designed to identify baseline predictors of preference and to determine if expectations and preferences for different doses of yoga affect back-related function and low back pain intensity. Methods: This was a secondary data analysis of a 12-week randomized controlled trial comparing once-weekly vs twice-weekly yoga for treatment of chronic low back pain in 93 adults from a predominantly low-income minority population. At baseline, participants were asked about back function, back pain, treatment expectations, and treatment preferences. We created a variable “concordance” to describe the matching of participant preference to randomized treatment. Our outcome variables were change in back function and pain intensity after 12 weeks of yoga instruction. We performed logistic regression to identify predictors of preference for once- or twice-weekly yoga instruction. We created linear regression models to identify independent associations between expectations, preference, concordance, and outcomes. Results: Worse back function at baseline was associated with 20% higher odds of preferring twice-weekly yoga (OR 1.2, CI 1.1, 1.3). Individuals with higher expectation scores for twice-weekly yoga had 90% higher odds of preferring twice-weekly vs once-weekly yoga (OR 1.9, CI 1.3, 2.7). Individuals with higher expectation scores for once-weekly yoga had 40% less odds of preferring twice-weekly yoga (OR 0.6, CI 0.5, 0.9). After controlling for baseline characteristics, we found no statistically significant relationship between treatment outcomes, preference, expectation scores, or concordance. Conclusion: In a population of predominantly low-income minority participants with chronic low back pain, worse back function was associated with preference for more frequent yoga classes. Those who preferred more yoga classes had higher expectations for those classes. Twelve-week change in back pain intensity and back function were not affected by dosing preference, expectation score, or concordance. More research is needed to better measure and quantify preference, expectations, and their relationship to outcomes in yoga research. PMID:25694850

Nurse-Moderated Internet-Based Support for New Mothers: Non-Inferiority, Randomized Controlled Trial.

PubMed

Sawyer, Michael G; Reece, Christy E; Bowering, Kerrie; Jeffs, Debra; Sawyer, Alyssa C P; Mittinty, Murthy; Lynch, John W

2017-07-24

Internet-based interventions moderated by community nurses have the potential to improve support offered to new mothers, many of whom now make extensive use of the Internet to obtain information about infant care. However, evidence from population-based randomized controlled trials is lacking. The aim of this study was to test the non-inferiority of outcomes for mothers and infants who received a clinic-based postnatal health check plus nurse-moderated, Internet-based group support when infants were aged 1-7 months as compared with outcomes for those who received standard care consisting of postnatal home-based support provided by a community nurse. The design of the study was a pragmatic, preference, non-inferiority randomized control trial. Participants were recruited from mothers contacted for their postnatal health check, which is offered to all mothers in South Australia. Mothers were assigned either (1) on the basis of their preference to clinic+Internet or home-based support groups (n=328), or (2) randomly assigned to clinic+Internet or home-based groups if they declared no strong preference (n=491). The overall response rate was 44.8% (819/1827). The primary outcome was parenting self-competence, as measured by the Parenting Stress Index (PSI) Competence subscale, and the Karitane Parenting Confidence Scale scores. Secondary outcome measures included PSI Isolation, Interpersonal Support Evaluation List-Short Form, Maternal Support Scale, Ages and Stages Questionnaire-Social-Emotional and MacArthur Communicative Development Inventory (MCDI) scores. Assessments were completed offline via self-assessment questionnaires at enrolment (mean child age=4.1 weeks, SD 1.3) and again when infants were aged 9, 15, and 21 months. Generalized estimating equations adjusting for post-randomization baseline imbalances showed that differences in outcomes between mothers in the clinic+Internet and home-based support groups did not exceed the pre-specified margin of inferiority (0.25 of a SD) on any outcome measure at any follow-up assessment, with the exception of MCDI scores assessing children's language development at 21 months for randomized mothers, and PSI Isolation scores at 9 months for preference mothers. Maternal and child outcomes from a clinic-based postnatal health check plus nurse-moderated Internet-based support were not inferior to those achieved by a universal home-based postnatal support program. Postnatal maternal and infant support using the Internet is a promising alternative to home-based universal support programs. Australian New Zealand Clinical Trials Registry Number (ANZCTR): ACTRN12613000204741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363712&isReview=true (Archived by WebCite at http://www.webcitation.org/6rZeCJ3k1). ©Michael G Sawyer, Christy E Reece, Kerrie Bowering, Debra Jeffs, Alyssa C P Sawyer, Murthy Mittinty, John W Lynch. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 24.07.2017.

Long-acting reversible contraceptive acceptability and unintended pregnancy among women presenting for short-acting methods: a randomized patient preference trial.

PubMed

Hubacher, David; Spector, Hannah; Monteith, Charles; Chen, Pai-Lien; Hart, Catherine

2017-02-01

Measures of contraceptive effectiveness combine technology and user-related factors. Observational studies show higher effectiveness of long-acting reversible contraception compared with short-acting reversible contraception. Women who choose long-acting reversible contraception may differ in key ways from women who choose short-acting reversible contraception, and it may be these differences that are responsible for the high effectiveness of long-acting reversible contraception. Wider use of long-acting reversible contraception is recommended, but scientific evidence of acceptability and successful use is lacking in a population that typically opts for short-acting methods. The objective of the study was to reduce bias in measuring contraceptive effectiveness and better isolate the independent role that long-acting reversible contraception has in preventing unintended pregnancy relative to short-acting reversible contraception. We conducted a partially randomized patient preference trial and recruited women aged 18-29 years who were seeking a short-acting method (pills or injectable). Participants who agreed to randomization were assigned to 1 of 2 categories: long-acting reversible contraception or short-acting reversible contraception. Women who declined randomization but agreed to follow-up in the observational cohort chose their preferred method. Under randomization, participants chose a specific method in the category and received it for free, whereas participants in the preference cohort paid for the contraception in their usual fashion. Participants were followed up prospectively to measure primary outcomes of method continuation and unintended pregnancy at 12 months. Kaplan-Meier techniques were used to estimate method continuation probabilities. Intent-to-treat principles were applied after method initiation for comparing incidence of unintended pregnancy. We also measured acceptability in terms of level of happiness with the products. Of the 916 participants, 43% chose randomization and 57% chose the preference option. Complete loss to follow-up at 12 months was <2%. The 12-month method continuation probabilities were 63.3% (95% confidence interval, 58.9-67.3) (preference short-acting reversible contraception), 53.0% (95% confidence interval, 45.7-59.8) (randomized short-acting reversible contraception), and 77.8% (95% confidence interval, 71.0-83.2) (randomized long-acting reversible contraception) (P < .001 in the primary comparison involving randomized groups). The 12-month cumulative unintended pregnancy probabilities were 6.4% (95% confidence interval, 4.1-8.7) (preference short-acting reversible contraception), 7.7% (95% confidence interval, 3.3-12.1) (randomized short-acting reversible contraception), and 0.7% (95% confidence interval, 0.0-4.7) (randomized long-acting reversible contraception) (P = .01 when comparing randomized groups). In the secondary comparisons involving only short-acting reversible contraception users, the continuation probability was higher in the preference group compared with the randomized group (P = .04). However, the short-acting reversible contraception randomized group and short-acting reversible contraception preference group had statistically equivalent rates of unintended pregnancy (P = .77). Seventy-eight percent of randomized long-acting reversible contraception users were happy/neutral with their initial method, compared with 89% of randomized short-acting reversible contraception users (P < .05). However, among method continuers at 12 months, all groups were equally happy/neutral (>90%). Even in a typical population of women who presented to initiate or continue short-acting reversible contraception, long-acting reversible contraception proved highly acceptable. One year after initiation, women randomized to long-acting reversible contraception had high continuation rates and consequently experienced superior protection from unintended pregnancy compared with women using short-acting reversible contraception; these findings are attributable to the initial technology and not underlying factors that often bias observational estimates of effectiveness. The similarly patterned experiences of the 2 short-acting reversible contraception cohorts provide a bridge of generalizability between the randomized group and usual-care preference group. Benefits of increased voluntary uptake of long-acting reversible contraception may extend to wider populations than previously thought. Copyright © 2016 Elsevier Inc. All rights reserved.

Dental Students' Preference with Regard to Tactile or Visual Determination of Injection Site for an Inferior Alveolar Nerve Block in Children: A Crossover Randomized Clinical Trial.

PubMed

Ramazani, Nahid; Iranmanesh, Seyed Masoud

2016-01-01

Instruction of local anesthesia injection in an important part of dental education curricula. This study was performed to compare dental students' preference with regard to tactile or visual determination of injection site for an inferior alveolar nerve block (IANB) in children. This crossover randomized clinical trial was conducted on dental students of Zahedan Dental School who took the first practical course of pediatric dentistry in the first academic semester of 2013-14 (n=42). They were randomly divided into two groups. During the first phase, group I was instructed to find the needle insertion point for an IANB via tactile method and group II was instructed to do it visually. In the second phase, the groups received instructions for the alternate technique. Both instructions were done using live demonstrations by the same instructor and immediately after instruction the learners practiced an IANB using the taught method. A five-point Likert scale questionnaire was then filled out by the students. The preference score was determined by calculating the mean of item scores. Data were analyzed using Mann-Whitney U and Wilcoxon Singed Rank tests in SPSS 19 at P=0.05 level of significance. Thirty-eight students completed the study. By using the visual method to perform an IANB, students gained a significantly higher mean preference score (P=0.020). There was a significant difference in the preference of male students (P=0.008). Instruction of IANB by visual identification of needle insertion point is more desirable by students.

Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state) - A prospective multicenter randomized controlled clinical trial using a comprehensive cohort design

PubMed Central

2009-01-01

Background Modern radiotherapy plays an important role in therapy of advanced head and neck carcinomas. However, no clinical studies have been published addressing the effectiveness of postoperative radiotherapy in patients with small tumor (pT1, pT2) and concomitant ipsilateral metastasis of a single lymph node (pN1), which would provide a basis for a general treatment recommendation. Methods/Design The present study is a non-blinded, prospective, multi-center randomized controlled trial (RCT). As the primary clinical endpoint, overall-survival in patients receiving postoperative radiation therapy vs. patients without adjuvant therapy following curative intended surgery is compared. The aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (irradiation/no irradiation). Since patients with small tumor (T1/T2) but singular lymph node metastasis are rare and the amount of patients consenting to randomization is not predictable in advance, all patients rejecting randomization will be treated as preferred and enrolled in a prospective observational study (comprehensive cohort design) after giving informed consent. This observational part of the trial will be performed with maximum consistency to the treatment and observation protocol of the RCT. Because the impact of patient preference for a certain treatment option is not calculable, parallel design of RCT and observational study may provide a maximum of evidence and efficacy for evaluation of treatment outcome. Secondary clinical endpoints are as follows: incidence and time to tumor relapse (locoregional relapse, lymph node involvement and distant metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module), and time from operation to orofacial rehabilitation. All tumors represent a homogeneous clinical state and therefore additional investigation of protein expression levels within resection specimen may serve for establishment of surrogate parameters of patient outcome. Conclusion The inherent challenges of a rare clinical condition (pN1) and two substantially different therapy arms would limit the practicality of a classical randomized study. The concept of a Comprehensive Cohort Design combines the preference of a randomized study, with the option of careful data interpretation within an observational study. Trial registration ClinicalTrials.gov: NCT00964977 PMID:20028566

The Impact of the 6:3 Polyunsaturated Fatty Acid Ratio on Intermediate Markers of Breast Cancer

DTIC Science & Technology

2008-05-01

randomized clinical trial of a standard versus vegetarian diet for weight loss: the impact of treatment preference. Int J Obes. 2008; 32: 166-76. o...Burke L, Hudson A, Styn M, Warziski M, Ulci O, Sereika S. Effects of a vegetarian diet and treatment preference on biological and dietary variables in...a standard versus vegetarian diet for weight loss: the impact of treatment preference. Int J Obes. 2008; 32: 166-76. Burke L, Hudson A, Styn M

Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state)--a prospective multicenter randomized controlled clinical trial using a comprehensive cohort design.

PubMed

Moergel, Maximilian; Jahn-Eimermacher, Antje; Krummenauer, Frank; Reichert, Torsten E; Wagner, Wilfried; Wendt, Thomas G; Werner, Jochen A; Al-Nawas, Bilal

2009-12-23

Modern radiotherapy plays an important role in therapy of advanced head and neck carcinomas. However, no clinical studies have been published addressing the effectiveness of postoperative radiotherapy in patients with small tumor (pT1, pT2) and concomitant ipsilateral metastasis of a single lymph node (pN1), which would provide a basis for a general treatment recommendation. The present study is a non-blinded, prospective, multi-center randomized controlled trial (RCT). As the primary clinical endpoint, overall-survival in patients receiving postoperative radiation therapy vs. patients without adjuvant therapy following curative intended surgery is compared. The aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (irradiation/no irradiation). Since patients with small tumor (T1/T2) but singular lymph node metastasis are rare and the amount of patients consenting to randomization is not predictable in advance, all patients rejecting randomization will be treated as preferred and enrolled in a prospective observational study (comprehensive cohort design) after giving informed consent. This observational part of the trial will be performed with maximum consistency to the treatment and observation protocol of the RCT. Because the impact of patient preference for a certain treatment option is not calculable, parallel design of RCT and observational study may provide a maximum of evidence and efficacy for evaluation of treatment outcome. Secondary clinical endpoints are as follows: incidence and time to tumor relapse (locoregional relapse, lymph node involvement and distant metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module), and time from operation to orofacial rehabilitation. All tumors represent a homogeneous clinical state and therefore additional investigation of protein expression levels within resection specimen may serve for establishment of surrogate parameters of patient outcome. The inherent challenges of a rare clinical condition (pN1) and two substantially different therapy arms would limit the practicality of a classical randomized study. The concept of a Comprehensive Cohort Design combines the preference of a randomized study, with the option of careful data interpretation within an observational study. ClinicalTrials.gov: NCT00964977.

Effects of viewing an evidence-based video decision aid on patients' treatment preferences for spine surgery.

PubMed

Lurie, Jon D; Spratt, Kevin F; Blood, Emily A; Tosteson, Tor D; Tosteson, Anna N A; Weinstein, James N

2011-08-15

Secondary analysis within a large clinical trial. To evaluate the changes in treatment preference before and after watching a video decision aid as part of an informed consent process. A randomized trial with a similar decision aid in herniated disc patients had shown decreased rate of surgery in the video group, but the effect of the video on expressed preferences is not known. Subjects enrolling in the Spine Patient Outcomes Research Trial (SPORT) with intervertebral disc herniation, spinal stenosis, or degenerative spondylolisthesis at 13 multidisciplinary spine centers across the United States were given an evidence-based videotape decision aid viewed prior to enrollment as part of informed consent. Of the 2505 patients, 86% (n = 2151) watched the video and 14% (n = 354) did not. Watchers shifted their preference more often than nonwatchers (37.9% vs. 20.8%, P < 0.0001) and more often demonstrated a strengthened preference (26.2% vs. 11.1%, P < 0.0001). Among the 806 patients whose preference shifted after watching the video, 55% shifted toward surgery (P = 0.003). Among the 617 who started with no preference, after the video 27% preferred nonoperative care, 22% preferred surgery, and 51% remained uncertain. After watching the evidence-based patient decision aid (video) used in SPORT, patients with specific lumbar spine disorders formed and/or strengthened their treatment preferences in a balanced way that did not appear biased toward or away from surgery.

Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial--design and methods.

PubMed

Wei, John; Nygaard, Ingrid; Richter, Holly; Brown, Morton; Barber, Matthew; Xiao Xu; Kenton, Kimberly; Nager, Charles; Schaffer, Joseph; Visco, Anthony; Weber, Anne

2009-04-01

The primary aims of this trial are to determine whether the use of a concomitant prophylactic anti-incontinence procedure may prevent stress urinary incontinence symptom development in women undergoing vaginal prolapse surgery and to evaluate the cost-effectiveness of this prophylactic approach. To present the rationale and design of a randomized controlled surgical trial (RCT), the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) Trial highlighting the challenges in the design and implementation. The challenges of implementing this surgical trial combined with a cost-effectiveness study and patient preference group are discussed including the study design, ethical issues regarding use of sham incision, maintaining the masking of study staff, and pragmatic difficulties encountered in the collection of cost data. The trial is conducted by the NICHD-funded Pelvic Floor Disorders Network. The ongoing OPUS trial started enrollment in May 2007 with a planned accrual of 350. The use of sham incision was generally well accepted but the collection of cost data using conventional billing forms was found to potentially unmask key study personnel. This necessitated changes in the study forms and planned timing for collection of cost data. To date, the enrollment to the patient preference group has been lower than the limit established by the protocol suggesting a willingness on the part of women to participate in the randomization. Given the invasive nature of surgical intervention trials, potential participants may be reluctant to accept random assignment, potentially impacting generalizability. Findings from the OPUS trial will provide important information that will help surgeons to better counsel women on the benefits and risks of concomitant prophylactic anti-incontinence procedure at the time of vaginal surgery for prolapse. The implementation of the OPUS trial has necessitated that investigators consider ethical issues up front, remain flexible with regards to data collection and be constantly aware of unanticipated opportunities for unmasking. Future surgical trials should be aware of potential challenges in maintaining masking and collection of cost-related information.

Acceptability of Home-Assessment Post Medical Abortion and Medical Abortion in a Low-Resource Setting in Rajasthan, India. Secondary Outcome Analysis of a Non-Inferiority Randomized Controlled Trial

PubMed Central

Paul, Mandira; Iyengar, Kirti; Essén, Birgitta; Gemzell-Danielsson, Kristina; Iyengar, Sharad D.; Bring, Johan; Soni, Sunita; Klingberg-Allvin, Marie

2015-01-01

Background Studies evaluating acceptability of simplified follow-up after medical abortion have focused on high-resource or urban settings where telephones, road connections, and modes of transport are available and where women have formal education. Objective To investigate women’s acceptability of home-assessment of abortion and whether acceptability of medical abortion differs by in-clinic or home-assessment of abortion outcome in a low-resource setting in India. Design Secondary outcome of a randomised, controlled, non-inferiority trial. Setting Outpatient primary health care clinics in rural and urban Rajasthan, India. Population Women were eligible if they sought abortion with a gestation up to 9 weeks, lived within defined study area and agreed to follow-up. Women were ineligible if they had known contraindications to medical abortion, haemoglobin < 85mg/l and were below 18 years. Methods Abortion outcome assessment through routine clinic follow-up by a doctor was compared with home-assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet. A computerized random number generator generated the randomisation sequence (1:1) in blocks of six. Research assistants randomly allocated eligible women who opted for medical abortion (mifepristone and misoprostol), using opaque sealed envelopes. Blinding during outcome assessment was not possible. Main Outcome Measures Women’s acceptability of home-assessment was measured as future preference of follow-up. Overall satisfaction, expectations, and comparison with previous abortion experiences were compared between study groups. Results 731 women were randomized to the clinic follow-up group (n = 353) or home-assessment group (n = 378). 623 (85%) women were successfully followed up, of those 597 (96%) were satisfied and 592 (95%) found the abortion better or as expected, with no difference between study groups. The majority, 355 (57%) women, preferred home-assessment in the event of a future abortion. Significantly more women, 284 (82%), in the home-assessment group preferred home-assessment in the future, as compared with 188 (70%) of women in the clinic follow-up group, who preferred clinic follow-up in the future (p < 0.001). Conclusion Home-assessment is highly acceptable among women in low-resource, and rural, settings. The choice to follow-up an early medical abortion according to women’s preference should be offered to foster women’s reproductive autonomy. Trial Registration ClinicalTrials.gov NCT01827995 PMID:26327217

Personal navigation increases colorectal cancer screening uptake.

PubMed

Ritvo, Paul G; Myers, Ronald E; Paszat, Lawrence F; Tinmouth, Jill M; McColeman, Joshua; Mitchell, Brian; Serenity, Mardie; Rabeneck, Linda

2015-03-01

Prior randomized, controlled trials (RCTs) indicate that patient navigation can boost colorectal cancer screening rates in primary care. The sparse literature on pragmatic trials of interventions designed to increase colorectal cancer screening adherence motivated this trial on the impact of a patient navigation intervention that included support for performance of the participants' preferred screening test (colonoscopy or stool blood testing). Primary care patients (n = 5,240), 50 to 74 years of age, with no prior diagnosis of bowel cancer and no record of a recent colorectal cancer screening test, were identified at the Group Health Centre in northern Ontario. These patients were randomly assigned to an intervention group (n = 2,629) or a usual care control group (n = 2,611). Intervention group participants were contacted by a trained nurse navigator by telephone to discuss colorectal cancer screening. Interested patients met with the navigator, who helped them identify and arrange for performance of the preferred screening test. Control group participants received usual care. Multivariate analyses were conducted using medical records data to assess intervention impact on screening adherence within 12 months after randomization. Mean patient age was 59 years, and 50% of participants were women. Colorectal cancer screening adherence was higher in the intervention group (35%) than in the control group (20%), a difference that was statistically significant (OR, 2.11; confidence interval, 1.87-2.39). Preference-based patient navigation increased screening uptake in a pragmatic RCT. Patient navigation increased colorectal cancer screening rates in a pragmatic RCT in proportions similar to those observed in explanatory RCTs. ©2014 American Association for Cancer Research.

A randomized clinical trial investigating treatment choice in Chinese men receiving sildenafil citrate and tadalafil for treating erectile dysfunction

PubMed Central

Bai, Wen-Jun; Li, Hong-Jun; Jin, Jian-Jun; Xu, Wen-Ping; Sebastian, Sorsaburu; Wang, Xiao-Feng

2017-01-01

Sildenafil and tadalafil are efficacious and well tolerated in Chinese men with erectile dysfunction (ED). Recent study results indicate that men with ED in China who were naïve to phosphodiesterase inhibitor type 5 (PDE5) therapy prefer tadalafil 20-mg (on-demand) versus sildenafil 100-mg (on-demand). Differences in psychosocial outcomes may help to explain treatment preference in favor of tadalafil. This open-label, randomized, crossover study compared psychosocial outcomes and drug attribute choices between tadalafil and sildenafil in Chinese men with ED naïve to PDE5 inhibitor therapy. Eligible patients were randomized to sequential 20-mg tadalafil/100-mg sildenafil (n = 190) or 100-mg sildenafil/20-mg tadalafil (n = 193) for 8 weeks each and were asked which treatment they preferred to take for the 8-week extension phase. Psychosocial outcomes were assessed using the Psychological and Interpersonal Relationship Scale (PAIRS), Drug Attributes Questionnaire (DRAQ), and Sexual Life Quality Questionnaire (SLQQ). When taking tadalafil versus sildenafil, men had a higher mean endpoint score on the PAIRS Spontaneity Domain (tadalafil = 2.86 vs sildenafil = 2.72; P < 0.001), and a lower mean endpoint score on the Time Concerns Domain (tadalafil = 2.41 vs sildenafil = 2.55; P < 0.001). A numerical increase in the Sexual Self-Confidence Domain was observed when taking tadalafil versus sildenafil (tadalafil = 2.76 vs sildenafil = 2.72; P = 0.102). The most frequently chosen drug attributes explaining treatment preference were able to get an erection long after having drug, and ability to get an erection every time. SLQQ results were comparable between treatment groups. These psychosocial outcomes may explain why more Chinese men preferred tadalafil versus sildenafil for the treatment of ED in this clinical trial. PMID:27101805

A randomized clinical trial investigating treatment choice in Chinese men receiving sildenafil citrate and tadalafil for treating erectile dysfunction.

PubMed

Bai, Wen-Jun; Li, Hong-Jun; Jin, Jian-Jun; Xu, Wen-Ping; Sebastian, Sorsaburu; Wang, Xiao-Feng

2017-01-01

Sildenafil and tadalafil are efficacious and well tolerated in Chinese men with erectile dysfunction (ED). Recent study results indicate that men with ED in China who were naïve to phosphodiesterase inhibitor type 5 (PDE5) therapy prefer tadalafil 20-mg (on-demand) versus sildenafil 100-mg (on-demand). Differences in psychosocial outcomes may help to explain treatment preference in favor of tadalafil. This open-label, randomized, crossover study compared psychosocial outcomes and drug attribute choices between tadalafil and sildenafil in Chinese men with ED naïve to PDE5 inhibitor therapy. Eligible patients were randomized to sequential 20-mg tadalafil/100-mg sildenafil (n = 190) or 100-mg sildenafil/20-mg tadalafil (n = 193) for 8 weeks each and were asked which treatment they preferred to take for the 8-week extension phase. Psychosocial outcomes were assessed using the Psychological and Interpersonal Relationship Scale (PAIRS), Drug Attributes Questionnaire (DRAQ), and Sexual Life Quality Questionnaire (SLQQ). When taking tadalafil versus sildenafil, men had a higher mean endpoint score on the PAIRS Spontaneity Domain (tadalafil = 2.86 vs sildenafil = 2.72; P < 0.001), and a lower mean endpoint score on the Time Concerns Domain (tadalafil = 2.41 vs sildenafil = 2.55; P < 0.001). A numerical increase in the Sexual Self-Confidence Domain was observed when taking tadalafil versus sildenafil (tadalafil = 2.76 vs sildenafil = 2.72; P = 0.102). The most frequently chosen drug attributes explaining treatment preference were able to get an erection long after having drug, and ability to get an erection every time. SLQQ results were comparable between treatment groups. These psychosocial outcomes may explain why more Chinese men preferred tadalafil versus sildenafil for the treatment of ED in this clinical trial.

Dental Students’ Preference with Regard to Tactile or Visual Determination of Injection Site for an Inferior Alveolar Nerve Block in Children: A Crossover Randomized Clinical Trial

PubMed Central

Iranmanesh, Seyed Masoud

2016-01-01

Objectives: Instruction of local anesthesia injection in an important part of dental education curricula. This study was performed to compare dental students’ preference with regard to tactile or visual determination of injection site for an inferior alveolar nerve block (IANB) in children. Materials and Methods: This crossover randomized clinical trial was conducted on dental students of Zahedan Dental School who took the first practical course of pediatric dentistry in the first academic semester of 2013–14 (n=42). They were randomly divided into two groups. During the first phase, group I was instructed to find the needle insertion point for an IANB via tactile method and group II was instructed to do it visually. In the second phase, the groups received instructions for the alternate technique. Both instructions were done using live demonstrations by the same instructor and immediately after instruction the learners practiced an IANB using the taught method. A five-point Likert scale questionnaire was then filled out by the students. The preference score was determined by calculating the mean of item scores. Data were analyzed using Mann-Whitney U and Wilcoxon Singed Rank tests in SPSS 19 at P=0.05 level of significance. Results: Thirty-eight students completed the study. By using the visual method to perform an IANB, students gained a significantly higher mean preference score (P=0.020). There was a significant difference in the preference of male students (P=0.008). Conclusions: Instruction of IANB by visual identification of needle insertion point is more desirable by students. PMID:27536327

Effects of Viewing an Evidence-Based Video Decision Aid on Patients’ Treatment Preferences for Spine Surgery

PubMed Central

Lurie, Jon D.; Spratt, Kevin F.; Blood, Emily A.; Tosteson, Tor D.; Tosteson, Anna N. A.; Weinstein, James N.

2011-01-01

Study Design Secondary analysis within a large clinical trial Objective To evaluate the changes in treatment preference before and after watching a video decision aid as part of an informed consent process. Summary of Background Data A randomized trial with a similar decision aid in herniated disc patients had shown decreased rate of surgery in the video group, but the effect of the video on expressed preferences is not known. Methods Subjects enrolling in the Spine Patient Outcomes Research Trial (SPORT) with intervertebral disc herniation (IDH), spinal stenosis (SPS), or degenerative spondylolisthesis (DS) at thirteen multidisciplinary spine centers across the US were given an evidence-based videotape decision aid viewed prior to enrollment as part of informed consent. Results Of the 2505 patients, 86% (n=2151) watched the video and 14% (n=354) did not. Watchers shifted their preference more often than non-watchers(37.9% vs. 20.8%, p < 0.0001) and more often demonstrated a strengthened preference (26.2% vs. 11.1%, p < 0.0001). Among the 806 patients whose preference shifted after watching the video, 55% shifted toward surgery (p=0.003). Among the 617 who started with no preference, after the video 27% preferred non-operative care, 22% preferred surgery, and 51% remained uncertain. Conclusion After watching the evidence-based patient decision aid (video) used in SPORT, patients with specific lumbar spine disorders formed and/or strengthened their treatment preferences in a balanced way that did not appear biased toward or away from surgery. PMID:21358485

Should multiple imputation be the method of choice for handling missing data in randomized trials?

PubMed Central

Sullivan, Thomas R; White, Ian R; Salter, Amy B; Ryan, Philip; Lee, Katherine J

2016-01-01

The use of multiple imputation has increased markedly in recent years, and journal reviewers may expect to see multiple imputation used to handle missing data. However in randomized trials, where treatment group is always observed and independent of baseline covariates, other approaches may be preferable. Using data simulation we evaluated multiple imputation, performed both overall and separately by randomized group, across a range of commonly encountered scenarios. We considered both missing outcome and missing baseline data, with missing outcome data induced under missing at random mechanisms. Provided the analysis model was correctly specified, multiple imputation produced unbiased treatment effect estimates, but alternative unbiased approaches were often more efficient. When the analysis model overlooked an interaction effect involving randomized group, multiple imputation produced biased estimates of the average treatment effect when applied to missing outcome data, unless imputation was performed separately by randomized group. Based on these results, we conclude that multiple imputation should not be seen as the only acceptable way to handle missing data in randomized trials. In settings where multiple imputation is adopted, we recommend that imputation is carried out separately by randomized group. PMID:28034175

Should multiple imputation be the method of choice for handling missing data in randomized trials?

PubMed

Sullivan, Thomas R; White, Ian R; Salter, Amy B; Ryan, Philip; Lee, Katherine J

2016-01-01

The use of multiple imputation has increased markedly in recent years, and journal reviewers may expect to see multiple imputation used to handle missing data. However in randomized trials, where treatment group is always observed and independent of baseline covariates, other approaches may be preferable. Using data simulation we evaluated multiple imputation, performed both overall and separately by randomized group, across a range of commonly encountered scenarios. We considered both missing outcome and missing baseline data, with missing outcome data induced under missing at random mechanisms. Provided the analysis model was correctly specified, multiple imputation produced unbiased treatment effect estimates, but alternative unbiased approaches were often more efficient. When the analysis model overlooked an interaction effect involving randomized group, multiple imputation produced biased estimates of the average treatment effect when applied to missing outcome data, unless imputation was performed separately by randomized group. Based on these results, we conclude that multiple imputation should not be seen as the only acceptable way to handle missing data in randomized trials. In settings where multiple imputation is adopted, we recommend that imputation is carried out separately by randomized group.

Improving GRADE evidence tables part 1: a randomized trial shows improved understanding of content in summary of findings tables with a new format.

PubMed

Carrasco-Labra, Alonso; Brignardello-Petersen, Romina; Santesso, Nancy; Neumann, Ignacio; Mustafa, Reem A; Mbuagbaw, Lawrence; Etxeandia Ikobaltzeta, Itziar; De Stio, Catherine; McCullagh, Lauren J; Alonso-Coello, Pablo; Meerpohl, Joerg J; Vandvik, Per Olav; Brozek, Jan L; Akl, Elie A; Bossuyt, Patrick; Churchill, Rachel; Glenton, Claire; Rosenbaum, Sarah; Tugwell, Peter; Welch, Vivian; Garner, Paul; Guyatt, Gordon; Schünemann, Holger J

2016-06-01

The current format of summary of findings (SoFs) tables for presenting effect estimates and associated quality of evidence improve understanding and assist users finding key information in systematic reviews. Users of SoF tables have demanded alternative formats to express findings from systematic reviews. We conducted a randomized controlled trial among systematic review users to compare the relative merits of a new format with the current formats of SoF tables regarding understanding, accessibility of information, satisfaction, and preference. Our primary goal was to show that the new format is not inferior to the current format. Of 390 potentially eligible subjects, 290 were randomized. Of seven items testing understanding, three showed similar results, two showed small differences favoring the new format, and two (understanding risk difference and quality of the evidence associated with a treatment effect) showed large differences favoring the new format [63% (95% confidence interval {CI}: 55, 71) and 62% (95% CI: 52, 71) more correct answers, respectively]. Respondents rated information in the alternative format as more accessible overall and preferred the new format over the current format. While providing at least similar levels of understanding for some items and increased understanding for others, users prefer the new format of SoF tables. Copyright © 2016 Elsevier Inc. All rights reserved.

A randomized controlled trial of the Cool Teens CD-ROM computerized program for adolescent anxiety.

PubMed

Wuthrich, Viviana M; Rapee, Ronald M; Cunningham, Michael J; Lyneham, Heidi J; Hudson, Jennifer L; Schniering, Carolyn A

2012-03-01

Computerized cognitive behavioral interventions for anxiety disorders in adults have been shown to be efficacious, but limited data are available on the use of computerized interventions with young persons. Adolescents in particular are difficult to engage in treatment and may be especially suited to computerized technologies. This paper describes the results of a small randomized controlled trial of the Cool Teens program for adolescent anxiety, and examines potential barriers to treatment and user preferences of computerized technology in this population. Forty-three adolescents with a primary diagnosis of anxiety were randomly allocated to the Cool Teens program, a 12-week computerized cognitive-behavioral therapy program for anxiety management, or a 12-week wait list. Effects on symptoms, negative thoughts, and life interference were assessed at post-treatment and 3-month follow-up, based on diagnosis as well as self and maternal report. Using mixed-model analyses, at post-treatment and follow-up assessments, adolescents in the Cool Teens condition, compared with those on the wait list, were found to have significant reductions in the total number of anxiety disorders, the severity of the primary anxiety disorder, and the average severity for all disorders. These results were matched by significant reductions in mother and child questionnaire reports of anxiety, internalizing symptoms, automatic thoughts, and life interference. Further few barriers to treatment were found, and user preferences indicated that the computerized treatment was well suited to adolescents with anxiety. The Cool Teens program is efficacious for treatment of adolescent anxiety. Clinical trial registration information-A randomized controlled trial of the Cool Teens computerized program for anxious adolescents compared with waist list; http://www.anzctr.org.au; ACTRN12611000508976. Copyright © 2012 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Impact of self-assessment questions and learning styles in Web-based learning: a randomized, controlled, crossover trial.

PubMed

Cook, David A; Thompson, Warren G; Thomas, Kris G; Thomas, Matthew R; Pankratz, V Shane

2006-03-01

To determine the effect of self-assessment questions on learners' knowledge and format preference in a Web-based course, and investigate associations between learning styles and outcomes. The authors conducted a randomized, controlled, crossover trial in the continuity clinics of the Mayo-Rochester internal medicine residency program during the 2003-04 academic year. Case-based self-assessment questions were added to Web-based modules covering topics in ambulatory internal medicine. Participants completed two modules with questions and two modules without questions, with sequence randomly assigned. Outcomes included knowledge assessed after each module, format preference, and learning style assessed using the Index of Learning Styles. A total of 121 of 146 residents (83%) consented. Residents had higher test scores when using the question format (mean +/- standard error, 78.9% +/- 1.0) than when using the standard format (76.2% +/- 1.0, p = .006). Residents preferring the question format scored higher (79.7% +/- 1.1) than those preferring standard (69.5% +/- 2.3, p < .001). Learning styles did not affect scores except that visual-verbal "intermediate" learners (80.6% +/- 1.4) and visual learners (77.5% +/- 1.3) did better than verbal learners (70.9% +/- 3.0, p = .003 and p = .033, respectively). Sixty-five of 78 residents (83.3%, 95% CI 73.2-90.8%) preferred the question format. Learning styles were not associated with preference (p > .384). Although the question format took longer than the standard format (60.4 +/- 3.6 versus 44.3 +/- 3.3 minutes, p < .001), 55 of 77 residents (71.4%, 60.0-81.2%) reported that it was more efficient. Instructional methods that actively engage learners improve learning outcomes. These findings hold implications for both Web-based learning and "traditional" educational activities. Future research, in both Web-based learning and other teaching modalities, should focus on further defining the effectiveness of selected instructional methods in specific learning contexts.

A Randomized Controlled Trial of Cognitive Behavioral Therapy (CBT) for Adjusting to Multiple Sclerosis (The saMS Trial): Does CBT Work and for Whom Does It Work?

ERIC Educational Resources Information Center

Moss-Morris, Rona; Dennison, Laura; Landau, Sabine; Yardley, Lucy; Silber, Eli; Chalder, Trudie

2013-01-01

Objective: The aims were (a) to test the effectiveness of a nurse-led cognitive behavioral therapy (CBT) program to assist adjustment in the early stages of multiple sclerosis (MS) and (b) to determine moderators of treatment including baseline distress, social support (SS), and treatment preference. Method: Ninety-four ambulatory people with MS…

Designing Studies That Would Address the Multilayered Nature of Health Care

PubMed Central

Pennell, Michael; Rhoda, Dale; Hade, Erinn M.; Paskett, Electra D.

2010-01-01

We review design and analytic methods available for multilevel interventions in cancer research with particular attention to study design, sample size requirements, and potential to provide statistical evidence for causal inference. The most appropriate methods will depend on the stage of development of the research and whether randomization is possible. Early on, fractional factorial designs may be used to screen intervention components, particularly when randomization of individuals is possible. Quasi-experimental designs, including time-series and multiple baseline designs, can be useful once the intervention is designed because they require few sites and can provide the preliminary evidence to plan efficacy studies. In efficacy and effectiveness studies, group-randomized trials are preferred when randomization is possible and regression discontinuity designs are preferred otherwise if assignment based on a quantitative score is possible. Quasi-experimental designs may be used, especially when combined with recent developments in analytic methods to reduce bias in effect estimates. PMID:20386057

How Important Is ‘Accuracy’ of Surrogate Decision-Making for Research Participation?

PubMed Central

Kim, Scott Y. H.; Kim, H. Myra; Ryan, Kerry A.; Appelbaum, Paul S.; Knopman, David S.; Damschroder, Laura; De Vries, Raymond

2013-01-01

Background There is a longstanding concern about the accuracy of surrogate consent in representing the health care and research preferences of those who lose their ability to decide for themselves. We sought informed, deliberative views of the older general public (≥50 years old) regarding their willingness to participate in dementia research and to grant leeway to future surrogates to choose an option contrary to their stated wishes. Methodology/Principal Findings 503 persons aged 50+ recruited by random digit dialing were randomly assigned to one of three groups: deliberation, education, or control. The deliberation group attended an all-day education/peer deliberation session; the education group received written information only. Participants were surveyed at baseline, after the deliberation session (or equivalent time), and one month after the session, regarding their willingness to participate in dementia research and to give leeway to surrogates, regarding studies of varying risk-benefit profiles (a lumbar puncture study, a drug randomized controlled trial, a vaccine randomized controlled trial, and an early phase gene transfer trial). At baseline, 48% (gene transfer scenario) to 92% (drug RCT) were willing to participate in future dementia research. A majority of respondents (57–71% depending on scenario) were willing to give leeway to future surrogate decision-makers. Democratic deliberation increased willingness to participate in all scenarios, to grant leeway in 3 of 4 scenarios (lumbar puncture, vaccine, and gene transfer), and to enroll loved ones in research in all scenarios. On average, respondents were more willing to volunteer themselves for research than to enroll their loved ones. Conclusions/Significance Most people were willing to grant leeway to their surrogates, and this willingness was either sustained or increased after democratic deliberation, suggesting that the attitude toward leeway is a reliable opinion. Eliciting a person’s current preferences about future research participation should also involve eliciting his or her leeway preferences. PMID:23382969

Using Video Images to Improve the Accuracy of Surrogate Decision-Making: A Randomized Controlled Trial

PubMed Central

Volandes, Angelo E.; Mitchell, Susan L.; Gillick, Muriel R.; Chang, Yuchiao; Paasche-Orlow, Michael K.

2009-01-01

Introduction When patients are unable to make important end-of-life decisions, doctors ask surrogate decision makers to provide insight into patients’ preferences. Unfortunately, multiple studies have shown that surrogates’ knowledge of patient preferences is poor. We hypothesized that a video decision tool would improve concordance between patients and their surrogates for end-of-life preferences. Objective To compare the concordance of preferences among elderly patients and their surrogates listening to only a verbal description of advanced dementia or viewing a video decision support tool of the disease after hearing the verbal description. Methods This was a randomized controlled trial of a convenience sample of community-dwelling elderly subjects (≥65 years) and their surrogates, and was conducted at 2 geriatric clinics affiliated with 2 academic medical centers in Boston. The study was conducted between September 1, 2007, and May 30, 2008. Random assignment of patient and surrogate dyads was to either a verbal narrative or a video decision support tool after the verbal narrative. End points were goals of care chosen by the patient and predicted goals of care by the surrogate. Goals of care included life-prolonging care (CPR, mechanical ventilation), limited care (hospitalization, antibiotics, but not CPR), and comfort care (only treatment to relieve symptoms). The primary outcome measure was the concordance rate of preferences between patients and their surrogates. Results A total of 14 pairs of patients and their surrogates were randomized to verbal narrative (n = 6) or video after verbal narrative (n = 8). Among the 6 patients receiving only the verbal narrative, 3 (50%) preferred comfort care, 1 (17%) chose limited care, and 2 (33%) desired life-prolonging care. Among the surrogates for these patients, only 2 correctly chose what their loved one would want if in a state of advanced dementia, yielding a concordance rate of 33%. Among the 8 patients receiving the video decision support tool, all 8 chose comfort care. Among the surrogates for these patients, all 8 correctly chose what their loved one would want if in a state of advanced dementia, yielding a concordance rate of 100%. Conclusion Patients and surrogates viewing a video decision support tool for advanced dementia are more likely to concur about the patient’s end-of-life preferences than when solely listening to a verbal description of the disease. PMID:19808156

Does biomarker information impact breast cancer patients' preferences and physician recommendation for adjuvant chemotherapy?

PubMed

Partridge, Ann H; Sepucha, Karen; O'Neill, Anne; Miller, Kathy D; Baker, Emily; Dang, Chau T; Northfelt, Donald W; Sledge, George W; Schneider, Bryan P

2017-10-01

This study aimed to examine how biomarker information would impact patients' preferences and physicians' recommendations for adjuvant breast cancer therapy. At the 18-month follow-up, participants in a large, double-blind randomized controlled trial of adjuvant chemotherapy with bevacizumab or placebo (E5103) were surveyed about their preferred treatment (either chemotherapy A alone or chemotherapy A+B) in two hypothetical scenarios: (1) without biomarker information; and (2) after learning that they tested positive for a "B-receptor" which modestly increased both the benefit and toxicity expected with chemotherapy A+B. We performed a cross-sectional analysis of the prospectively collected survey data and used the McNemar's test to examine changes in treatment preferences. A one-time survey of clinical investigators who enrolled patients on the trial evaluated physician recommendations in response to the same biomarker information. 439 patients completed both scenarios on 18-month survey. Most participants preferred A+B in both scenario 1 and 2 (77 and 76% respectively). The increase in benefit and toxicity associated with the positive biomarker information in scenario 2 led 60/439 (14%) of patients to switch their treatment preference. The corresponding physician survey revealed that most physicians chose regimen A+B in scenario 1 (77%), and moreso after the biomarker information was available in scenario 2 (84%). Information about a positive biomarker indicating increased benefit and toxicity from additional chemotherapy did not change many participants' preferred treatment. The majority preferred the most effective course in both scenarios. Similarly, most investigators discounted increased toxicity and valued increased benefit. Parent Trial Registration: NCT00433511.

Informing hot flash treatment decisions for breast cancer survivors: a systematic review of randomized trials comparing active interventions.

PubMed

Johns, Claire; Seav, Susan M; Dominick, Sally A; Gorman, Jessica R; Li, Hongying; Natarajan, Loki; Mao, Jun James; Irene Su, H

2016-04-01

Patient-centered decision making about hot flash treatments often incorporates a balance of efficacy and side effects in addition to patient preference. This systematic review examines randomized controlled trials (RCTs) comparing at least two non-hormonal hot flash treatments in breast cancer survivors. In July 2015, PubMed, SCOPUS, CINAHL, Cochrane, and Web of Science databases were searched for RCTs comparing active, non-hormonal hot flash treatments in female breast cancer survivors. Thirteen trials were included after identifying 906 potential studies. Four trials were dose comparison studies of pharmacologic treatments citalopram, venlafaxine, gabapentin, and paroxetine. Hot flash reduction did not differ by tamoxifen or aromatase inhibitor use. Citalopram 10, 20, and 30 mg daily had comparable outcomes. Venlafaxine 75 mg daily improved hot flashes without additional side effects from higher dosing. Gabapentin 900 mg daily improved hot flashes more than 300 mg. Paroxetine 10 mg daily had fewer side effects than 20 mg. Among four trials comparing different pharmacologic treatments, venlafaxine alleviated hot flash symptoms faster than clonidine; participants preferred venlafaxine over gabapentin. Five trials compared pharmacologic to non-pharmacologic treatments. Acupuncture had similar efficacy to venlafaxine and gabapentin but may have longer durability after completing treatment and fewer side effects. We could not perform a pooled meta-analysis because outcomes were not reported in comparable formats. Clinical trial data on non-hormonal hot flash treatments provide comparisons of hot flash efficacy and other patient important outcomes to guide clinical management. Clinicians can use the information to help patients select hot flash interventions.

A Model-Based Product Evaluation Protocol for Comparison of Safety-Engineered Protection Mechanisms of Winged Blood Collection Needles.

PubMed

Haupt, C; Spaeth, J; Ahne, T; Goebel, U; Steinmann, D

2016-05-01

To evaluate differences in product characteristics and user preferences of safety-engineered protection mechanisms of winged blood collection needles. Randomized model-based simulation study. University medical center. A total of 33 third-year medical students. Venipuncture was performed using winged blood collection needles with 4 different safety mechanisms: (a) Venofix Safety, (b) BD Vacutainer Push Button, (c) Safety-Multifly, and (d) Surshield Surflo. Each needle type was used in 3 consecutive tries: there was an uninstructed first handling, then instructions were given according to the operating manual; subsequently, a first trial and second trial were conducted. Study end points included successful activation, activation time, single-handed activation, correct activation, possible risk of needlestick injury, possibility of deactivation, and preferred safety mechanism. The overall successful activation rate during the second trial was equal for all 4 devices (94%-100%). Median activation time was (a) 7 s, (b) 2 s, (c) 9 s, and (d) 7 s. Single-handed activation during the second trial was (a) 18%, (b) 82%, (c) 15%, and (d) 45%. Correct activation during the second trial was (a) 3%, (b) 64%, (c) 15%, and (d) 39%. Possible risk of needlestick injury during the second trial was highest with (d). Possibility of deactivation was (a) 0%, (b) 12%, (c) 9%, and (d) 18%. Individual preferences for each system were (a) 11, (b) 17, (c) 5, and (d) 0. The main reason for preference was the comprehensive safety mechanism. Significant differences exist between safety mechanisms of winged blood collection needles.

Effect of Allowing Choice of Diet on Weight Loss: A Randomized Trial.

PubMed

Yancy, William S; Mayer, Stephanie B; Coffman, Cynthia J; Smith, Valerie A; Kolotkin, Ronette L; Geiselman, Paula J; McVay, Megan A; Oddone, Eugene Z; Voils, Corrine I

2015-06-16

Choosing a diet rather than being prescribed one could improve weight loss. To examine whether offering choice of diet improves weight loss. Double-randomized preference trial of choice between 2 diets (choice) versus random assignment to a diet (comparator) over 48 weeks. (ClinicalTrials.gov: NCT01152359). Outpatient clinic at a Veterans Affairs medical center. Outpatients with a body mass index of at least 30 kg/m2. Choice participants received information about their food preferences and 2 diet options (low-carbohydrate diet [LCD] or low-fat diet [LFD]) before choosing and were allowed to switch diets at 12 weeks. Comparator participants were randomly assigned to 1 diet for 48 weeks. Both groups received group and telephone counseling for 48 weeks. The primary outcome was weight at 48 weeks. Of 105 choice participants, 61 (58%) chose the LCD and 44 (42%) chose the LFD; 5 (3 on the LCD and 2 on the LFD) switched diets at 12 weeks, and 87 (83%) completed measurements at 48 weeks. Of 102 comparator participants, 53 (52%) were randomly assigned to the LCD and 49 (48%) were assigned to the LFD; 88 (86%) completed measurements. At 48 weeks, estimated mean weight loss was 5.7 kg (95% CI, 4.3 to 7.0 kg) in the choice group and 6.7 kg (CI, 5.4 to 8.0 kg) in the comparator group (mean difference, -1.1 kg [CI, -2.9 to 0.8 kg]; P = 0.26). Secondary outcomes of dietary adherence, physical activity, and weight-related quality of life were similar between groups at 48 weeks. Only 2 diet options were provided. Results from this sample of older veterans might not be generalizable to other populations. Contrary to expectations, the opportunity to choose a diet did not improve weight loss.

Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial.

PubMed

Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

2018-01-01

To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Participants' homes across Cambridgeshire, UK. Eleven people with stroke and arm hemiparesis, 3-60 months post stroke, following discharge from community rehabilitation. Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. ClinicalTrials.gov identifier NCT 02310438.

Development of a cross-over randomized trial method to determine the acceptability and safety of novel ready-to-use therapeutic foods.

PubMed

Dibari, Filippo; Bahwere, Paluku; Huerga, Helena; Irena, Abel Hailu; Owino, Victor; Collins, Steve; Seal, Andrew

2013-01-01

To develop a method for determining the acceptability and safety of ready-to-use therapeutic foods (RUTF) before clinical trialing. Acceptability was defined using a combination of three consumption, nine safety, and six preference criteria. These were used to compare a soy/maize/sorghum RUTF (SMS-RUTFh), designed for the rehabilitation of human immunodeficiency virus/tuberculosis (HIV/TB) wasted adults, with a peanut-butter/milk-powder paste (P-RUTF; brand: Plumpy'nut) designed for pediatric treatment. A cross-over, randomized, controlled trial was conducted in Kenya. Ten days of repeated measures of product intake by 41 HIV/TB patients, >18 y old, body mass index (BMI) 18-24 kg · m(-2), 250 g were offered daily under direct observation as a replacement lunch meal. Consumption, comorbidity, and preferences were recorded. The study arms had similar age, sex, marital status, initial BMI, and middle upper-arm circumference. No carryover effect or serious adverse events were found. SMS-RUTFh energy intake was not statistically different from the control, when adjusted for BMI on day 1, and the presence of throat sores. General preference, taste, and sweetness scores were higher for SMS-RUTFh compared to the control (P < 0.05). Most consumption, safety, and preference criteria for SMS-RUTFh were satisfied except for the average number of days of nausea (0.16 versus 0.09 d) and vomiting (0.04 versus 0.02 d), which occurred with a higher frequency (P < 0.05). SMS-RUTFh appears to be acceptable and can be safely clinically trialed, if close monitoring of vomiting and nausea is included. The method reported here is a useful and feasible approach for testing the acceptability of ready-to-use foods in low income countries. Copyright © 2013 Elsevier Inc. All rights reserved.

Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial

PubMed Central

Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

2017-01-01

Objective: To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. Design: A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Setting: Participants’ homes across Cambridgeshire, UK. Subjects: Eleven people with stroke and arm hemiparesis, 3–60 months post stroke, following discharge from community rehabilitation. Interventions: Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Main measures: Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. Results: A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. Conclusion: It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. Trial registration: ClinicalTrials.gov identifier NCT 02310438. PMID:28643570

Adjunctive social media for more effective contraceptive counseling: a randomized controlled trial.

PubMed

Kofinas, Jason D; Varrey, Aneesha; Sapra, Katherine J; Kanj, Rula V; Chervenak, Frank A; Asfaw, Tirsit

2014-04-01

To determine whether social media, specifically Facebook, is an effective tool for improving contraceptive knowledge. English-speaking women aged 18-45 years receiving care at an urban academic center obstetrics and gynecology clinic were included and randomized to a trial of standard contraceptive education and pamphlet (n=74) compared with standard contraceptive education and Facebook (n=69) information for contraception counseling. Contraceptive knowledge was evaluated preintervention and postintervention by the Contraceptive Knowledge Inventory. We evaluated the effect of the intervention by raw score and percent increase in Contraceptive Knowledge Inventory score, participant satisfaction with counseling method, and contraceptive preference postintervention. All analyses were stratified by age group. The median raw postintervention Contraceptive Knowledge Inventory score was significantly higher in the Facebook compared with the pamphlet group (15 compared with 12, P<.001) as was percentage increase in the Contraceptive Knowledge Inventory score (36% compared with 12%, P<.001). Participant satisfaction with counseling method was significantly higher in the Facebook group (median 10 compared with 6, P<.001). Participant contraceptive preference for long-acting reversible contraceptives (LARCs; intrauterine device or implant) postintervention was significantly greater in the Facebook compared with the pamphlet group (57% compared with 35%, P=.01). Among women currently using none or barrier contraception, contraceptive preference for implants was significantly greater in the Facebook compared with the pamphlet group (26% compared with 5%, P=.02), although, when analysis was extended to include implant or intrauterine device, LARCs were not significantly higher in the Facebook compared with the pamphlet group (48% compared with 33%, P=.19). Social media as an adjunct to traditional in-office counseling improves patient contraceptive knowledge and increases patient preference for LARCs. ClinicalTrials.gov, www.clinicaltrials.gov, NCT01994005.

Design, recruitment outcomes, and sample characteristics of the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial.

PubMed

Krebs, Erin E; Jensen, Agnes C; Nugent, Sean; DeRonne, Beth; Rutks, Indulis; Leverty, David; Gravely, Amy; Noorbaloochi, Siamak; Bair, Matthew J; Kroenke, Kurt

2017-11-01

This manuscript describes the study protocol, recruitment outcomes, and baseline participant characteristics for the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial. SPACE is a pragmatic randomized comparative effectiveness trial conducted in multiple VA primary care clinics within one VA health care system. The objective was to compare benefits and harms of opioid therapy versus non-opioid medication therapy over 12months among patients with moderate-to-severe chronic back pain or hip/knee osteoarthritis pain despite analgesic therapy; patients already receiving regular opioid therapy were excluded. Key design features include comparing two clinically-relevant medication interventions, pragmatic eligibility criteria, and flexible treat-to-target interventions. Screening, recruitment and study enrollment were conducted over 31months. A total of 4491 patients were contacted for eligibility screening; 53.1% were ineligible, 41.0% refused, and 5.9% enrolled. The most common reasons for ineligibility were not meeting pain location and severity criteria. The most common study-specific reasons for refusal were preference for no opioid use and preference for no pain medications. Of 265 enrolled patients, 25 withdrew before randomization. Of 240 randomized patients, 87.9% were male, 84.1% were white, and age range was 21-80years. Past-year mental health diagnoses were 28.3% depression, 17% anxiety, 9.4% PTSD, 7.9% alcohol use disorder, and 2.6% drug use disorder. In conclusion, although recruitment for this trial was challenging, characteristics of enrolled participants suggest we were successful in recruiting patients similar to those prescribed opioid therapy in usual care. Published by Elsevier Inc.

Treatment credibility, expectancy, and preference: Prediction of treatment engagement and outcome in a randomized clinical trial of hatha yoga vs. health education as adjunct treatments for depression.

PubMed

Uebelacker, Lisa A; Weinstock, Lauren M; Battle, Cynthia L; Abrantes, Ana M; Miller, Ivan W

2018-06-02

Hatha yoga may be helpful for alleviating depression symptoms. The purpose of this analysis is to determine whether treatment program preference, credibility, or expectancy predict engagement in depression interventions (yoga or a control class) or depression symptom severity over time. This is a secondary analysis of a randomized controlled trial (RCT) of hatha yoga vs. a health education control group for treatment of depression. Depressed participants (n = 122) attended up to 20 classes over a period of 10 weeks, and then completed additional assessments after 3 and 6 months. We assessed treatment preference prior to randomization, and treatment credibility and expectancy after participants attended their first class. Treatment "concordance" indicated that treatment preference matched assigned treatment. Treatment credibility, expectancy, and concordance were not associated with treatment engagement. Treatment expectancy moderated the association between treatment group and depression. Depression severity over time differed by expectancy level for the yoga group but not for the health education group. Controlling for baseline depression, participants in the yoga group with an average or high expectancy for improvement showed lower depression symptoms across the acute intervention and follow-up period than those with a low expectancy for improvement. There was a trend for a similar pattern for credibility. Concordance was not associated with treatment outcome. This is a secondary, post-hoc analysis and should be considered hypothesis-generating. Results suggest that expectancy improves the likelihood of success only for a intervention thought to actively target depression (yoga) and not a control intervention. Copyright © 2018. Published by Elsevier B.V.

Guideline attribute and implementation preferences among physicians in multiple health systems.

PubMed

Stone, Tamara T; Schweikhart, Sharon B; Mantese, Annamarie; Sonnad, Seema S

2005-01-01

Although practice guidelines are effective in assisting providers with clinical decision making, ineffective implementation strategies often prevent their use in practice. This study aimed to understand physician preferences for guideline format, placement, content, evidence, and learning strategies in different clinical environments. Semistructured telephone interviews were conducted with 500 randomly selected physicians from 4 major US health systems who were involved in the treatment of patients with acute myocardial infarction or pediatric asthma. Paired sample t tests and Tukey's method of comparisons determined the relative ranking of physicians' guideline implementation preferences. Physicians preferred guidelines located on the front of the patient chart, in palm pilots, or in progress notes and presented as flow charts/flow diagrams, algorithms, or preprinted orders that contain strategies to minimize readmits/encourage self-management and immediate treatment flows. Discussions with colleagues and continuing medical education are the most effective strategies for encouraging guideline use, and randomized controlled trials remain the most persuasive medical evidence. Health care organizations must align guideline implementation efforts with physician preferences to encourage utilization. The results of this study reveal systematic physician preferences for guideline implementation that can be applied to clinical settings to encourage guideline use by physicians.

Dose-Response Effects of Aerobic Exercise on Quality of Life in Postmenopausal Women: Results from the Breast Cancer and Exercise Trial in Alberta (BETA).

PubMed

Courneya, Kerry S; McNeil, Jessica; O'Reilly, Rachel; Morielli, Andria R; Friedenreich, Christine M

2017-06-01

Exercise generally improves quality of life (QoL) and psychosocial functioning in adult populations but few randomized trials have examined dose-response effects. The purpose of the present study was to report the QoL and psychosocial outcomes from the Breast Cancer and Exercise Trial in Alberta (BETA). Healthy but inactive postmenopausal women at risk for breast cancer were randomized to a year-long aerobic exercise intervention consisting of either 150 min/week (moderate volume group, n = 200) or 300 min/week (high volume group, n = 200). QoL was assessed at baseline and 1 year using the short form-36 health survey. Sleep quality, depression, anxiety, stress, self-esteem, and happiness were also assessed. Participant preference for group assignment (i.e., exercise volume) was assessed at baseline and tested as a moderator. There were no statistically significant dose-response effects of aerobic exercise on any QoL, sleep quality, or psychosocial outcome. Participant preference for group assignment did not moderate any QoL, sleep quality, or psychosocial responses. Marital status was a significant moderator (p for interaction = 0.01) and obesity showed a trend towards being a moderator (p for interaction = 0.08) of the dose-response effects of aerobic exercise on global sleep quality such that unmarried and obese women improved sleep quality with the higher volume of aerobic exercise. A higher volume of aerobic exercise, approximately double the minimum public health guideline, did not provide additional QoL or psychosocial benefits compared to the minimum public health guideline in inactive postmenopausal women, even for women who preferred the higher volume of exercise at baseline. Trial Registration clinicaltrials.gov identifier: NCT1435005.

A Randomized Trial to Improve Communication About End-of-Life Care Among Patients With COPD

PubMed Central

Udris, Edmunds M.; Engelberg, Ruth A.; Diehr, Paula H.; Bryson, Christopher L.; Reinke, Lynn F.; Curtis, J. Randall

2012-01-01

Objective: Patients with COPD consistently express a desire to discuss end-of-life care with clinicians, but these discussions rarely occur. We assessed whether an intervention using patient-specific feedback about preferences for discussing end-of-life care would improve the occurrence and quality of communication between patients with COPD and their clinicians. Methods: We performed a cluster-randomized trial of clinicians and patients from the outpatient clinics at the Veterans Affairs Puget Sound Health Care System. Using self-reported questionnaires, we assessed patients’ preferences for communication, life-sustaining therapy, and experiences at the end of life. The intervention clinicians and patients received a one-page patient-specific feedback form, based on questionnaire responses, to stimulate conversations. The control group completed questionnaires but did not receive feedback. Patient-reported occurrence and quality of end-of-life communication (QOC) were assessed within 2 weeks of a targeted visit. Intention-to-treat regression analyses were performed with generalized estimating equations to account for clustering of patients within clinicians. Results: Ninety-two clinicians contributed 376 patients. Patients in the intervention arm reported nearly a threefold higher rate of discussions about end-of-life care (unadjusted, 30% vs 11%; P < .001). Baseline end-of-life communication was poor (intervention group QOC score, 23.3; 95% CI, 19.9-26.8; control QOC score, 19.2; 95% CI, 15.9-22.4). Patients in the intervention arm reported higher-quality end-of-life communication that was statistically significant, although the overall improvement was small (Cohen effect size, 0.21). Conclusions: A one-page patient-specific feedback form about preferences for end-of-life care and communication improved the occurrence and quality of communication from patients’ perspectives. Trial registry: ClinicalTrials.gov; No.: NCT00106080; URL: www.clinicaltrials.gov PMID:21940765

Decision Aid to Technologically Enhance Shared decision making (DATES): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Clinicians face challenges in promoting colorectal cancer screening due to multiple competing demands. A decision aid that clarifies patient preferences and improves decision quality can aid shared decision making and be effective at increasing colorectal cancer screening rates. However, exactly how such an intervention improves shared decision making is unclear. This study, funded by the National Cancer Institute, seeks to provide detailed understanding of how an interactive decision aid that elicits patient’s risks and preferences impacts patient-clinician communication and shared decision making, and ultimately colorectal cancer screening adherence. Methods/Design This is a two-armed single-blinded randomized controlled trial with the target of 300 patients per arm. The setting is eleven community and three academic primary care practices in Metro Detroit. Patients are men and women aged between 50 and 75 years who are not up to date on colorectal cancer screening. ColoDATES Web (intervention arm), a decision aid that incorporates interactive personal risk assessment and preference clarification tools, is compared to a non-interactive website that matches ColoDATES Web in content but does not contain interactive tools (control arm). Primary outcomes are patient uptake of colorectal cancer screening; patient decision quality (knowledge, preference clarification, intent); clinician’s degree of shared decision making; and patient-clinician concordance in the screening test chosen. Secondary outcome incorporates a Structural Equation Modeling approach to understand the mechanism of the causal pathway and test the validity of the proposed conceptual model based on Theory of Planned Behavior. Clinicians and those performing the analysis are blinded to arms. Discussion The central hypothesis is that ColoDATES Web will improve colorectal cancer screening adherence through improvement in patient behavioral factors, shared decision making between the patient and the clinician, and concordance between the patient’s and clinician’s preferred colorectal cancer screening test. The results of this study will be among the first to examine the effect of a real-time preference assessment exercise on colorectal cancer screening and mediators, and, in doing so, will shed light on the patient-clinician communication and shared decision making ‘black box’ that currently exists between the delivery of decision aids to patients and subsequent patient behavior. Trial Registration ClinicalTrials.gov ID NCT01514786 PMID:24216139

Do monkeys choose to choose?

PubMed

Perdue, Bonnie M; Evans, Theodore A; Washburn, David A; Rumbaugh, Duane M; Beran, Michael J

2014-06-01

Both empirical and anecdotal evidence supports the idea that choice is preferred by humans. Previous research has demonstrated that this preference extends to nonhuman animals, but it remains largely unknown whether animals will actively seek out or prefer opportunities to choose. Here we explored the issue of whether capuchin and rhesus monkeys choose to choose. We used a modified version of the SELECT task-a computer program in which monkeys can choose the order of completion of various psychomotor and cognitive tasks. In the present experiments, each trial began with a choice between two icons, one of which allowed the monkey to select the order of task completion, and the other of which led to the assignment of a task order by the computer. In either case, subjects still had to complete the same number of tasks and the same number of task trials. The tasks were relatively easy, and the monkeys responded correctly on most trials. Thus, global reinforcement rates were approximately equated across conditions. The only difference was whether the monkey chose the task order or it was assigned, thus isolating the act of choosing. Given sufficient experience with the task icons, all monkeys showed a significant preference for choice when the alternative was a randomly assigned order of tasks. To a lesser extent, some of the monkeys maintained a preference for choice over a preferred, but computer-assigned, task order that was yoked to their own previous choice selection. The results indicated that monkeys prefer to choose when all other aspects of the task are equated.

The Role of Visual Eccentricity on Preference for Abstract Symmetry

PubMed Central

O’ Sullivan, Noreen; Bertamini, Marco

2016-01-01

This study tested preference for abstract patterns, comparing random patterns to a two-fold bilateral symmetry. Stimuli were presented at random locations in the periphery. Preference for bilateral symmetry has been extensively studied in central vision, but evaluation at different locations had not been systematically investigated. Patterns were presented for 200 ms within a large circular region. On each trial participant changed fixation and were instructed to select any location. Eccentricity values were calculated a posteriori as the distance between ocular coordinates at pattern onset and coordinates for the centre of the pattern. Experiment 1 consisted of two Tasks. In Task 1, participants detected pattern regularity as fast as possible. In Task 2 they evaluated their liking for the pattern on a Likert-scale. Results from Task 1 revealed that with our parameters eccentricity did not affect symmetry detection. However, in Task 2, eccentricity predicted more negative evaluation of symmetry, but not random patterns. In Experiment 2 participants were either presented with symmetry or random patterns. Regularity was task-irrelevant in this task. Participants discriminated the proportion of black/white dots within the pattern and then evaluated their liking for the pattern. Even when only one type of regularity was presented and regularity was task-irrelevant, preference evaluation for symmetry decreased with increasing eccentricity, whereas eccentricity did not affect the evaluation of random patterns. We conclude that symmetry appreciation is higher for foveal presentation in a way not fully accounted for by sensitivity. PMID:27124081

The Role of Visual Eccentricity on Preference for Abstract Symmetry.

PubMed

Rampone, Giulia; O' Sullivan, Noreen; Bertamini, Marco

2016-01-01

This study tested preference for abstract patterns, comparing random patterns to a two-fold bilateral symmetry. Stimuli were presented at random locations in the periphery. Preference for bilateral symmetry has been extensively studied in central vision, but evaluation at different locations had not been systematically investigated. Patterns were presented for 200 ms within a large circular region. On each trial participant changed fixation and were instructed to select any location. Eccentricity values were calculated a posteriori as the distance between ocular coordinates at pattern onset and coordinates for the centre of the pattern. Experiment 1 consisted of two Tasks. In Task 1, participants detected pattern regularity as fast as possible. In Task 2 they evaluated their liking for the pattern on a Likert-scale. Results from Task 1 revealed that with our parameters eccentricity did not affect symmetry detection. However, in Task 2, eccentricity predicted more negative evaluation of symmetry, but not random patterns. In Experiment 2 participants were either presented with symmetry or random patterns. Regularity was task-irrelevant in this task. Participants discriminated the proportion of black/white dots within the pattern and then evaluated their liking for the pattern. Even when only one type of regularity was presented and regularity was task-irrelevant, preference evaluation for symmetry decreased with increasing eccentricity, whereas eccentricity did not affect the evaluation of random patterns. We conclude that symmetry appreciation is higher for foveal presentation in a way not fully accounted for by sensitivity.

A pragmatic trial to improve adherence with scheduled appointments in an inner-city pain clinic by human phone calls in the patient's preferred language.

PubMed

Andreae, Michael H; Nair, Singh; Gabry, Jonah S; Goodrich, Ben; Hall, Charles; Shaparin, Naum

2017-11-01

We investigated if human reminder phone calls in the patient's preferred language increase adherence with scheduled appointments in an inner-city chronic pain clinic. We hypothesized that language and cultural incongruence is the underlying mechanism to explain poor attendance at clinic appointments in underserved Hispanic populations. Pragmatic randomized controlled clinical trial SETTING: Innercity academic chronic pain clinic with a diverse, predominantly African-American and Hispanic population PATIENTS: All (n=963) adult patients with a scheduled first appointment between October 2014 and October 2015 at the Montefiore Pain Center in the Bronx, New York were enrolled. Patients were randomized to receive a human reminder call in their preferred language before their appointment, or no contact. We recorded patients' demographic characteristics and as primary outcome attendance as scheduled, failure to attend and/or cancellation calls. We fit Bayesian and classical multinomial logistic regression models to test if the intervention improved adherence with scheduled appointments. Among the 953 predominantly African American and Hispanic/Latino patients, 475 patients were randomly selected to receive a language-congruent, human reminder call, while 478 were assigned to receive no prior contact, (after we excluded 10 patients, scheduled for repeat appointments). In the experimental group, 275 patients adhered to their scheduled appointment, while 84 cancelled and 116 failed to attend. In the control group, 249 patients adhered to their scheduled appointment, 31 cancelled and 198 failed to attend. Human phone reminders in the preferred language increased adherence (RR 1.89, CI95% [1.42, 1.42], (p<0.01). The intervention seemed particularly effective in Hispanic patients, supporting our hypothesis of cultural congruence as possible underlying mechanism. Human reminder phone calls prior in the patient's preferred language increased adherence with scheduled appointments. The intervention facilitated access to much needed care in an ethnically diverse, resource poor population, presumably by overcoming language barriers. Copyright © 2017 Elsevier Inc. All rights reserved.

Promoting advance planning for health care and research among older adults: A randomized controlled trial

PubMed Central

2012-01-01

Background Family members are often required to act as substitute decision-makers when health care or research participation decisions must be made for an incapacitated relative. Yet most families are unable to accurately predict older adult preferences regarding future health care and willingness to engage in research studies. Discussion and documentation of preferences could improve proxies' abilities to decide for their loved ones. This trial assesses the efficacy of an advance planning intervention in improving the accuracy of substitute decision-making and increasing the frequency of documented preferences for health care and research. It also investigates the financial impact on the healthcare system of improving substitute decision-making. Methods/Design Dyads (n = 240) comprising an older adult and his/her self-selected proxy are randomly allocated to the experimental or control group, after stratification for type of designated proxy and self-report of prior documentation of healthcare preferences. At baseline, clinical and research vignettes are used to elicit older adult preferences and assess the ability of their proxy to predict those preferences. Responses are elicited under four health states, ranging from the subject's current health state to severe dementia. For each state, we estimated the public costs of the healthcare services that would typically be provided to a patient under these scenarios. Experimental dyads are visited at home, twice, by a specially trained facilitator who communicates the dyad-specific results of the concordance assessment, helps older adults convey their wishes to their proxies, and offers assistance in completing a guide entitled My Preferences that we designed specifically for that purpose. In between these meetings, experimental dyads attend a group information session about My Preferences. Control dyads attend three monthly workshops aimed at promoting healthy behaviors. Concordance assessments are repeated at the end of the intervention and 6 months later to assess improvement in predictive accuracy and cost savings, if any. Copies of completed guides are made at the time of these assessments. Discussion This study will determine whether the tested intervention guides proxies in making decisions that concur with those of older adults, motivates the latter to record their wishes in writing, and yields savings for the healthcare system. Trial Registration ISRCTN89993391 PMID:22221980

Well-Loved Music Robustly Relieves Pain: A Randomized, Controlled Trial

PubMed Central

Hsieh, Christine; Kong, Jian; Kirsch, Irving; Edwards, Robert R.; Jensen, Karin B.; Kaptchuk, Ted J.; Gollub, Randy L.

2014-01-01

Music has pain-relieving effects, but its mechanisms remain unclear. We sought to verify previously studied analgesic components and further elucidate the underpinnings of music analgesia. Using a well-characterized conditioning-enhanced placebo model, we examined whether boosting expectations would enhance or interfere with analgesia from strongly preferred music. A two-session experiment was performed with 48 healthy, pain experiment-naïve participants. In a first cohort, 36 were randomized into 3 treatment groups, including music enhanced with positive expectancy, non-musical sound enhanced with positive expectancy, and no expectancy enhancement. A separate replication cohort of 12 participants received only expectancy-enhanced music following the main experiment to verify the results of expectancy-manipulation on music. Primary outcome measures included the change in subjective pain ratings to calibrated experimental noxious heat stimuli, as well as changes in treatment expectations. Without conditioning, expectations were strongly in favor of music compared to non-musical sound. While measured expectations were enhanced by conditioning, this failed to affect either music or sound analgesia significantly. Strongly preferred music on its own was as pain relieving as conditioning-enhanced strongly preferred music, and more analgesic than enhanced sound. Our results demonstrate the pain-relieving power of personal music even over enhanced expectations. Trial Information Clinicaltrials.gov NCT01835275. PMID:25211164

The White Diet is preferred, better tolerated, and non-inferior to a clear-fluid diet for bowel preparation: A randomized controlled trial.

PubMed

Butt, Joshua; Bunn, Cate; Paul, Eldho; Gibson, Peter; Brown, Gregor

2016-02-01

Dietary restrictions contribute to the unpleasantness of bowel preparation for colonoscopy. We compare the effectiveness and tolerability of a low residue diet of white-colored foods ("White Diet") with a clear-fluid diet the day prior to colonoscopy in an endoscopist-blinded randomized non-inferiority trial. Adults undergoing outpatient colonoscopy were randomized with stratification by procedure timing to a White Diet or clear-fluid diet. All received a 2-L polyethylene glycol lavage solution with ascorbate, sodium sulfate, and electrolytes, the day-before for morning and as a split-dose for afternoon procedures. The primary end-point was successful bowel preparation (A or B on the Harefield Cleansing Scale). Regimen tolerance/acceptance was assessed by questionnaire. An intention-to-treat analysis with a predefined non-inferiority margin of 15% was used to compare efficacy. A total of 226 patients (average age 52 years, 51% male) were randomized (111 clear diet, 115 White Diet). Bowel preparation was successful in 91% on the clear-fluid diet vs 84.4% on the White Diet, difference being -6.6% (lower one sided 95% CI -13.8%), with no difference according to diet. The split-dose regimen (in 55%) had a higher success rate than day-before regimen (96% vs 80%, p < 0.001). The White Diet was preferred with less hunger and interference with daily activities (p < 0.001). Procedural/withdrawal time and polyp/adenoma detection were similar between groups. The White Diet was preferred and better tolerated by patients without detriment to the success of bowel preparation or colonoscopy performance, especially with the split-dose regimen. © 2015 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

Does clinical equipoise apply to cluster randomized trials in health research?

PubMed Central

2011-01-01

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act? In individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of clinical equipoise to CRTs is uncertain. Here we argue that clinical equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, clinical equipoise is applicable to CRTs. Clinical equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, clinical equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial. Finally, clinical equipoise provides research ethics committees with formal and procedural guidelines that form an important part of the assessment of the benefits and harms of CRTs in health research. PMID:21569349

A Randomized Controlled Trial of a CPR and Intubation Video Decision Support Tool for Hospitalized Patients.

PubMed

El-Jawahri, Areej; Mitchell, Susan L; Paasche-Orlow, Michael K; Temel, Jennifer S; Jackson, Vicki A; Rutledge, Renee R; Parikh, Mihir; Davis, Aretha D; Gillick, Muriel R; Barry, Michael J; Lopez, Lenny; Walker-Corkery, Elizabeth S; Chang, Yuchiao; Finn, Kathleen; Coley, Christopher; Volandes, Angelo E

2015-08-01

Decisions about cardiopulmonary resuscitation (CPR) and intubation are a core part of advance care planning, particularly for seriously ill hospitalized patients. However, these discussions are often avoided. We aimed to examine the impact of a video decision tool for CPR and intubation on patients' choices, knowledge, medical orders, and discussions with providers. This was a prospective randomized trial conducted between 9 March 2011 and 1 June 2013 on the internal medicine services at two hospitals in Boston. One hundred and fifty seriously ill hospitalized patients over the age of 60 with an advanced illness and a prognosis of 1 year or less were included. Mean age was 76 and 51% were women. Three-minute video describing CPR and intubation plus verbal communication of participants' preferences to their physicians (intervention) (N = 75) or control arm (usual care) (N = 75). The primary outcome was participants' preferences for CPR and intubation (immediately after viewing the video in the intervention arm). Secondary outcomes included: orders to withhold CPR/intubation, documented discussions with providers during hospitalization, and participants' knowledge of CPR/ intubation (five-item test, range 0-5, higher scores indicate greater knowledge). Intervention participants (vs. controls) were more likely not to want CPR (64% vs. 32%, p <0.0001) and intubation (72% vs. 43%, p < 0.0001). Intervention participants (vs. controls) were also more likely to have orders to withhold CPR (57% vs. 19%, p < 0.0001) and intubation (64% vs.19%, p < 0.0001) by hospital discharge, documented discussions about their preferences (81% vs. 43%, p < 0.0001), and higher mean knowledge scores (4.11 vs. 2.45; p < 0.0001). Seriously ill patients who viewed a video about CPR and intubation were more likely not to want these treatments, be better informed about their options, have orders to forgo CPR/ intubation, and discuss preferences with providers. Clinicaltrials.gov NCT01325519 Registry Name: A prospective randomized trial using video images in advance care planning in seriously ill hospitalized patients.

Systematic review of randomized controlled trials of low-carbohydrate vs. low-fat/low-calorie diets in the management of obesity and its comorbidities.

PubMed

Hession, M; Rolland, C; Kulkarni, U; Wise, A; Broom, J

2009-01-01

There are few studies comparing the effects of low-carbohydrate/high-protein diets with low-fat/high-carbohydrate diets for obesity and cardiovascular disease risk. This systematic review focuses on randomized controlled trials of low-carbohydrate diets compared with low-fat/low-calorie diets. Studies conducted in adult populations with mean or median body mass index of > or =28 kg m(-2) were included. Thirteen electronic databases were searched and randomized controlled trials from January 2000 to March 2007 were evaluated. Trials were included if they lasted at least 6 months and assessed the weight-loss effects of low-carbohydrate diets against low-fat/low-calorie diets. For each study, data were abstracted and checked by two researchers prior to electronic data entry. The computer program Review Manager 4.2.2 was used for the data analysis. Thirteen articles met the inclusion criteria. There were significant differences between the groups for weight, high-density lipoprotein cholesterol, triacylglycerols and systolic blood pressure, favouring the low-carbohydrate diet. There was a higher attrition rate in the low-fat compared with the low-carbohydrate groups suggesting a patient preference for a low-carbohydrate/high-protein approach as opposed to the Public Health preference of a low-fat/high-carbohydrate diet. Evidence from this systematic review demonstrates that low-carbohydrate/high-protein diets are more effective at 6 months and are as effective, if not more, as low-fat diets in reducing weight and cardiovascular disease risk up to 1 year. More evidence and longer-term studies are needed to assess the long-term cardiovascular benefits from the weight loss achieved using these diets.

A review of randomized controlled trials comparing the effectiveness of hand held computers with paper methods for data collection

PubMed Central

Lane, Shannon J; Heddle, Nancy M; Arnold, Emmy; Walker, Irwin

2006-01-01

Background Handheld computers are increasingly favoured over paper and pencil methods to capture data in clinical research. Methods This study systematically identified and reviewed randomized controlled trials (RCTs) that compared the two methods for self-recording and reporting data, and where at least one of the following outcomes was assessed: data accuracy; timeliness of data capture; and adherence to protocols for data collection. Results A comprehensive key word search of NLM Gateway's database yielded 9 studies fitting the criteria for inclusion. Data extraction was performed and checked by two of the authors. None of the studies included all outcomes. The results overall, favor handheld computers over paper and pencil for data collection among study participants but the data are not uniform for the different outcomes. Handheld computers appear superior in timeliness of receipt and data handling (four of four studies) and are preferred by most subjects (three of four studies). On the other hand, only one of the trials adequately compared adherence to instructions for recording and submission of data (handheld computers were superior), and comparisons of accuracy were inconsistent between five studies. Conclusion Handhelds are an effective alternative to paper and pencil modes of data collection; they are faster and were preferred by most users. PMID:16737535

Permissive or Trophic Enteral Nutrition and Full Enteral Nutrition Had Similar Effects on Clinical Outcomes in Intensive Care: A Systematic Review of Randomized Clinical Trials.

PubMed

Silva, Camila F A; de Vasconcelos, Simone G; da Silva, Thales A; Silva, Flávia M

2018-01-26

The aim of this study was to systematically review the effect of permissive underfeeding/trophic feeding on the clinical outcomes of critically ill patients. A systematic review of randomized clinical trials to evaluate the mortality, length of stay, and mechanical ventilation duration in patients randomized to either hypocaloric or full-energy enteral nutrition was performed. Data sources included PubMed and Scopus and the reference lists of the articles retrieved. Two independent reviewers participated in all phases of this systematic review as proposed by the Cochrane Handbook, and the review was reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A total of 7 randomized clinical trials that included a total of 1,717 patients were reviewed. Intensive care unit length of stay and mechanical ventilation duration were not statistically different between the intervention and control groups in all randomized clinical trials, and mortality rate was also not different between the groups. In conclusion, hypocaloric enteral nutrition had no significantly different effects on morbidity and mortality in critically ill patients when compared with full-energy nutrition. It is still necessary to determine the safety of this intervention in this group of patients, the optimal amount of energy provided, and the duration of this therapy. © 2018 American Society for Parenteral and Enteral Nutrition.

Virtual Reality Cognitive Behavior Therapy for Public Speaking Anxiety: A Randomized Clinical Trial

ERIC Educational Resources Information Center

Wallach, Helene S.; Safir, Marilyn P.; Bar-Zvi, Margalit

2009-01-01

Public speaking anxiety (PSA) is a common phobia. Although cognitive behavior therapy (CBT) is preferred, difficulties arise with the exposure component (lack of therapist control, patient's inability to imagine, self-flooding, loss of confidentiality resulting from public exposure). Virtual reality CBT (VRCBT) enables a high degree of therapist…

The effects of condom choice on self-reported condom use among men in Ghana, Kenya and South Africa: a randomized trial.

PubMed

Weaver, Mark A; Joanis, Carol; Toroitich-Ruto, Cathy; Parker, Warren; Gyamenah, Nana A; Rinaldi, Anne; Omungo, Zablon; Steiner, Markus J

2011-09-01

Male condoms are readily available and affordable in many settings, but risky sexual acts still go unprotected. This unblinded randomized trial, conducted in Ghana, Kenya and South Africa, was designed to assess the impact of providing a choice of condoms on self-reported use and uptake over 6 months. We enrolled 1,274 men. The mean subject-specific proportion of protected acts with all partners increased from baseline to 6 months by 0.07 in the control group compared to 0.03 in the choice group (p=.025). The observed results were largely consistent across all three countries. In the choice group, men clearly preferred one condom type over the others, and this preference was consistent across all three countries. Providing one type of male condom in public sector programs appears justified. Programs should not focus on the number of brands available, but should encourage effective promotion and consistent and correct use of available brands. Copyright © 2011 Elsevier Inc. All rights reserved.

Methods of pushing during vaginal delivery and pelvic floor and perineal outcomes: a review.

PubMed

de Tayrac, Renaud; Letouzey, Vincent

2016-12-01

Over the past 20 years, several randomized studies have compared Valsalva and spontaneous pushing techniques during vaginal delivery. This review summarizes current medical knowledge concerning their maternal and fetal consequences, focusing on pelvic and perineal outcomes. We selected nine randomized controlled trials comparing Valsalva and spontaneous pushing, and a secondary analysis of a randomized controlled trial comparing different methods of perineal protection. Two trials showed that spontaneous pushing reduces the risk of perineal tears, but no firm conclusions can be drawn given the heterogeneity and inconsistent results of these studies. Conflicting results have been reported regarding the duration of the second stage of labor. Pushing technique does not seem to affect episiotomy, instrumental delivery or cesarean rates. Maternal satisfaction seems to be better after spontaneous pushing. Spontaneous pushing appears to have no adverse effects on neonatal well being, and one study showed a significant improvement in prenatal fetal parameters during the expulsive phase. Valsalva and spontaneous pushing techniques currently appear comparable in terms of duration, pelvic floor, perineal, and neonatal outcomes. In the absence of strong evidence in favor of either technique, the decision should be guided by patient preference and the clinical situation. Additional, well-designed randomized controlled trials are required.

Technology and Information Tool Preferences of Academics in the Field of Anaesthesiology

PubMed Central

Akkaya, Akcan; Bilgi, Murat; Demirhan, Abdullah; Kurt, Adem Deniz; Tekelioğlu, Ümit Yaşar; Akkaya, Kadir; Koçoğlu, Hasan; Tekçe, Hikmet

2014-01-01

Objective Researchers use a large number of information technology tools from the beginning until the publication of a scientific study. The aim of the study is to investigate the technology and data processing tool usage preferences of academics who produce scientific publications in the field of anaesthesiology. Methods A multiple-choice survey, including 18 questions regarding the use of technology to assess the preferences of academicians, was performed. Results PubMed has been the most preferred article search portal, and the second is Google Academic. Medscape has become the most preferred medical innovation tracking website. Only 12% of academicians obtain a clinical trial registration number for their randomized clinical research. In total, 28% of respondents used the Consolidated Standards of Reporting Trials checklist in their clinical trials. Of all participants, 21% was using Dropbox and 9% was using Google-Drive for sharing files. Google Chrome was the most preferred internet browser (32.25%) for academic purposes. English language editing service was obtained from the Scribendi (21%) and Textcheck (12%) websites. Half of the academics were getting help from their specialist with a personal relationship, 27% was doing it themselves, and 24% was obtaining professional assistance for statistical requirements. Sixty percent of the participants were not using a reference editing program, and 21% was using EndNote. Nine percent of the academics were spending money for article writing, and the mean cost was 1287 Turkish Liras/year. Conclusion Academics in the field of anaesthesiology significantly benefit from technology and informatics tools to produce scientific publications. PMID:27366448

The influence of patients' preference/attitude towards psychotherapy and antidepressant medication on the treatment of major depressive disorder.

PubMed

Moradveisi, Latif; Huibers, Marcus; Renner, Fritz; Arntz, Arnoud

2014-03-01

Preferences and attitudes patients hold towards treatment are important, as these can influence treatment outcome. In depression research, the influence of patients' preference/attitudes on outcome and dropout has mainly been studied for antidepressant medication, and less for psychological treatments. We investigated the effects of patients' preference and attitudes towards psychological treatment and antidepressant medication on treatment outcome and dropout, and tested specificity of effects. Data are based on a randomized trial testing the effectiveness of behavioural activation (BA) vs antidepressant medication (ADM) for major depression (MDD) in Iran. Patients with MDD (N = 100) were randomized to BA (N = 50) or ADM (N = 50). Patients' preference/attitudes towards psychotherapy and ADM were assessed at baseline and associated with dropout and treatment outcome using logistic regression and multilevel analysis. High scores on psychotherapy preference/attitude and low scores on ADM preference/attitude predicted dropout from ADM, while no association between dropout and preference/attitude was found in BA. Psychotherapy preference/attitude moderated the differential effect of BA and ADM on one outcome measure, but the association disappeared after one year. Because in Iran most patients have only access to ADM, offering a psychological treatment for depression could attract especially those patients that prefer this newly available treatment. Patients' preferences and attitudes towards depression treatments influence dropout from ADM, and moderate the short-term difference in effectiveness between BA and ADM. The fact that dropout from BA was not affected by preference/attitude speaks for its acceptability among patients. Copyright © 2013 Elsevier Ltd. All rights reserved.

Prey preferences and prey acceptance in juvenile Brown Treesnakes (Boiga irregularis)

USGS Publications Warehouse

Lardner, Bjorn; Savidge, Julie A.; Rodda, Gordon H.; Reed, Robert N.

2009-01-01

On the Pacific island of Guam, control of the invasive Brown Treesnake (Boiga irregularis) relies largely on methods that use mice as bait. Juvenile B. irregularis feed primarily on lizards and their eggs, but little is known about their prey preference. We conducted an experiment to investigate preferences for, and acceptance of, dead geckos, skinks, and neonatal mice, in juvenile B. irregularis ranging from 290 mm to ca. 700 mm snout-vent length (SVL). Snakes of all sizes showed a preference for geckos over skinks and neonatal mice. Geckos were the first prey chosen in 87% of 224 initial trials (56 snakes subjected to four trials each; 33% would be expected from a random choice). The smallest snakes had the most pronounced preference. Although many of the snakes accepted neonatal mice and/or skinks, some snakes of all sizes were reluctant to feed on anything but geckos, especially when well fed. We also addressed the hypothesis that repeated encounters with a particular prey type increase a snake's preference for that prey. Our study does not support this hypothesis. Our results suggest that control methods relying solely on rodent bait may be inefficient for targeting snakes < 700 mm SVL and that individual heterogeneity in prey preference may cause a significant part of this juvenile cohort to be completely refractory to capture with rodent bait, even if the bait is dead and small enough to be readily swallowed.

Patients were more consistent in randomized trial at prioritizing childbirth preferences using graphic-numeric than verbal formats.

PubMed

Eden, Karen B; Dolan, James G; Perrin, Nancy A; Kocaoglu, Dundar; Anderson, Nicholas; Case, James; Guise, Jeanne-Marie

2009-04-01

We developed an evidence-based decision aid to help women with a prior cesarean to prioritize their childbirth preferences related to a future birth. Because there was uncertainty about which scale format would assist the patients in being most consistent in prioritizing preferences in a multiattribute decision model, we compared a graphic-numeric scale with a text-anchored scale. Ninety-six postnatal women with a prior cesarean were randomized to use 1 of 2 preference scale formats in a computerized childbirth decision aid. We measured the level of inconsistency (intransitivity) when patients prioritized their childbirth preferences and clarity of values before and after using the decision aid. When the trade-offs involved risk, women were more consistent when using graphic-numeric than text-anchored formats (P=0.015). They prioritized safety to their baby as 4 times more important than any other decision factor including safety to self. Both groups reduced unclear childbirth values over time (P<0.001). Women who over-used the extreme ends of the scale when evaluating risk were more likely to be inconsistent (P<0.001). Patients were more consistent in making trade-offs involving risk using graphic-numeric formats than text-anchored formats to measure patient preferences.

Informing men about prostate cancer screening: a randomized controlled trial of patient education materials.

PubMed

Ilic, Dragan; Egberts, Kristine; McKenzie, Joanne E; Risbridger, Gail; Green, Sally

2008-04-01

Patient education materials can assist patient decision making on prostate cancer screening. To explore the effectiveness of presenting health information on prostate cancer screening using video, internet, and written interventions on patient decision making, attitudes, knowledge, and screening interest. Randomized controlled trial. A total of 161 men aged over 45, who had never been screened for prostate cancer, were randomized to receive information on prostate cancer screening. Participants were assessed at baseline and 1-week postintervention for decisional conflict, screening interest, knowledge, anxiety, and decision-making preference. A total of 156 men were followed-up at 1-week postintervention. There was no statistical, or clinical, difference in mean change in decisional conflict scores between the 3 intervention groups (video vs internet -0.06 [95% CI -0.24 to 0.12]; video vs pamphlet 0.04 [95%CI -0.15 to 0.22]; internet vs pamphlet 0.10 [95%CI -0.09 to 0.28]). There was also no statistically significant difference in mean knowledge, anxiety, decision-making preference, and screening interest between the 3 intervention groups. Results from this study indicate that there are no clinically significant differences in decisional conflict when men are presented health information on prostate cancer screening via video, written materials, or the internet. Given the equivalence of the 3 methods, other factors need to be considered in deciding which method to use. Health professionals should provide patient health education materials via a method that is most convenient to the patient and their preferred learning style.

Educational videos to reduce racial disparities in ICD therapy via innovative designs (VIVID): a randomized clinical trial.

PubMed

Thomas, Kevin L; Zimmer, Louise O; Dai, David; Al-Khatib, Sana M; Allen LaPointe, Nancy M; Peterson, Eric D

2013-07-01

Black individuals eligible for an implantable cardioverter/defibrillator (ICD) are considerably less likely than white individuals to receive one. This disparity may, in part, be explained by racial differences in patient preferences. We hypothesized that a targeted patient-centered educational video could improve knowledge of sudden cardiac arrest (SCA) and ICDs and reduce racial differences in ICD preferences. We conducted a pilot study to assess the feasibility of testing this hypothesis in a randomized trial. We created a video that included animation, physician commentary, and patient testimonials on SCA and ICDs. The primary outcome was the decision to have an ICD implanted as a function of race and intervention. Between January 1, 2011, and December 31, 2011, 59 patients (37 white and 22 black) were randomized to the video or health care provider counseling/usual care. Relative to white patients, black patients were younger (median age, 55 vs 68 years) and more likely to have attended college or technical school. Baseline SCA and ICD knowledge was similar and improved significantly in both racial groups after the intervention. Black patients viewing the video were as likely as white patients to want an ICD (60.0% vs 79.2%, P = .20); and among those in the usual care arm, black patients were less likely than white patients to want an ICD (42.9% vs 84.6% P = .05). Among individuals eligible for an ICD, a video decision aid increased patient knowledge and reduced racial differences in patient preference for an ICD. Copyright © 2013 Mosby, Inc. All rights reserved.

Lack of interaction between sensing-intuitive learning styles and problem-first versus information-first instruction: a randomized crossover trial.

PubMed

Cook, David A; Thompson, Warren G; Thomas, Kris G; Thomas, Matthew R

2009-03-01

Adaptation to learning styles has been proposed to enhance learning. We hypothesized that learners with sensing learning style would perform better using a problem-first instructional method while intuitive learners would do better using an information-first method. Randomized, controlled, crossover trial. Resident ambulatory clinics. 123 internal medicine residents. Four Web-based modules in ambulatory internal medicine were developed in both "didactic" (information first, followed by patient problem and questions) and "problem" (case and questions first, followed by information) format. Knowledge posttest, format preference, learning style (Index of Learning Styles). Knowledge scores were similar between the didactic (mean +/- standard error, 83.0 +/- 0.8) and problem (82.3 +/- 0.8) formats (p = .42; 95% confidence interval [CI] for difference, -2.3 to 0.9). There was no difference between formats in regression slopes of knowledge scores on sensing-intuitive scores (p = .63) or in analysis of knowledge scores by styles classification (sensing 82.5 +/- 1.0, intermediate 83.7 +/- 1.2, intuitive 81.0 +/- 1.5; p = .37 for main effect, p = .59 for interaction with format). Format preference was neutral (3.2 +/- 0.2 [1 strongly prefers didactic, 6 strongly prefers problem], p = .12), and there was no association between learning styles and preference (p = .44). Formats were similar in time to complete modules (43.7 +/- 2.2 vs 43.2 +/- 2.2 minutes, p = .72). Starting instruction with a problem (versus employing problems later on) may not improve learning outcomes. Sensing and intuitive learners perform similarly following problem-first and didactic-first instruction. Results may apply to other instructional media.

Methodological challenges in evaluating the effectiveness of women's crisis houses compared with psychiatric wards: findings from a pilot patient preference RCT.

PubMed

Howard, Louise M; Leese, Morven; Byford, Sarah; Killaspy, Helen; Cole, Laura; Lawlor, Caroline; Johnson, Sonia

2009-10-01

There are several methodological difficulties to address when evaluating acute psychiatric services. This study explored potential methods in evaluating the effectiveness of women's crisis houses compared with psychiatric wards in a pilot patient preference randomized controlled trial. Women requiring voluntary admission to a psychiatric hospital or women's crisis house were asked to enter this pilot and different options for recruitment were explored, including different recruitment sites in the pathway to admission and methods for including women without capacity. Forty-one percent (n = 42) of women entering the study agreed to be randomized and 59% (n = 61) entered patient preference arms. Only 7% of women were recruited before admission and 1 woman without capacity entered the study, despite procedures to facilitate this. Recruitment of patients with acute psychiatric crises is therefore challenging; researchers evaluating acute services should establish a consensus on how ethically and practically to recruit patients in this setting.

A double-blind, crossover, randomized comparison of granisetron and ramosetron for the prevention of acute and delayed cisplatin-induced emesis in patients with gastrointestinal cancer: is patient preference a better primary endpoint?

PubMed

Koizumi, Wasaburo; Tanabe, Satoshi; Nagaba, Shizuka; Higuchi, Katsuhiko; Nakayama, Norisuke; Saigenji, Katsunori; Nonaka, Miwa; Yago, Kazuo

2003-12-01

Serotonin receptor antagonists are recommended by the American Society of Clinical Oncology for the prevention of acute and delayed chemotherapy-induced emesis. However, the most effective agent in this class of antiemetic drugs for preventing emesis has not been clearly defined. We therefore performed a double-blind, crossover, randomized, controlled trial comparing the efficacy of granisetron and ramosetron, using patient preference as the primary endpoint. Thirty patients receiving two courses of combined chemotherapy (including > or =60 mg/m(2) cisplatin) for gastric or esophageal cancer were randomly assigned to the granisetron-ramosetron group (treatment phase 1: granisetron, 3 mg; treatment phase 2: ramosetron, 0.3 mg) or the ramosetron-granisetron group (treatment phase 1: ramosetron, 0.3 mg; treatment phase 2: granisetron, 3 mg). All patients received methylprednisolone sodium, 250 mg i.v., during each treatment phase. The efficacy of granisetron and ramosetron was similar in terms of the suppression of emesis and appetite status. However, the majority of patients (19/30, 63.3%) expressed a preference for granisetron, as compared with 9 patients (30.0%) who preferred ramosetron; 2 patients (6.7%) had no preference (chi(2) test: p = 0.008; Fisher's exact test: p = 0.015). (1) A significant proportion of patients prefer granisetron over ramosetron for the prevention of chemotherapy-induced emesis. (2) Granisetron and ramosetron possess similar effectiveness for the suppression of emesis. (3) The variable of 'patient preference' should be accepted as a primary endpoint of antiemetic drug efficacy. Copyright 2003 S. Karger AG, Basel

Role of Internal Mammary Node Radiation as a Part of Modern Breast Cancer Radiation Therapy: A Systematic Review

DOE Office of Scientific and Technical Information (OSTI.GOV)

Verma, Vivek; Vicini, Frank; Tendulkar, Rahul D.

Purpose: Despite data from multiple randomized trials, the role of internal mammary lymph node irradiation as a part of regional nodal irradiation (IMLN RT–RNI) remains unanswered. Recent noteworthy data and modern RT techniques might identify a subset of patients who will benefit from IMLN RT–RNI, lending insight into the balance between improved outcomes and acceptable toxicity. We evaluated the current role of IMLN RT–RNI by analyzing randomized, prospective, and retrospective data. Methods and Materials: In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a review of the published data was performed using PubMed to evaluate publishedmore » studies from 1994 to 2015. The information evaluated included the number of patients, follow-up period, technical aspects of RT, and outcomes (clinical outcomes, complications/toxicity). Results: We included 16 studies (4 randomized, 4 nonrandomized, 7 retrospective, and 1 meta-analysis). Although older randomized trials failed to show differences in clinical outcomes or toxicity with IMLN RT–RNI, recent randomized data suggest the potential for improved outcomes, including overall survival, with IMLN RT–RNI. Furthermore, nonrandomized data have suggested a potential benefit for central tumors with IMLN RT–RNI. Although recent data have suggested a potential increase in pulmonary complications with IMLN RT–RNI with the use of advanced radiation techniques, toxicity rates remain low with limited cardiac toxicity data available. Conclusions: Increasing data from recent randomized trials support the use of IMLN RT–RNI. IMLN RT can be considered based on the inclusion of IMLN RT as a part of RNI in recent trials and the inclusion criteria from IMLN RT–RNI trials and for patients with central or medial tumors and axillary disease.« less

Nursing preference of topical silver sulfadiazine versus collagenase ointment for treatment of partial thickness burns in children: survey follow-up of a prospective randomized trial.

PubMed

Sharp, Nicole E; Aguayo, Pablo; Marx, Daniel J; Polak, Erin E; Rash, Diane E; Peter, Shawn D; Ostlie, Daniel J; Juang, David

2014-01-01

We performed a nursing survey to inquire about nursing preferences toward the use of silver sulfadiazine (SSD) and collagenase (CO). We performed a survey between September 2012 and December 2012 asking nurses to rate the application/removal of both products and provide a description of their preferences. Ten study nurses (83%) preferred CO over SSD (P < .001). Two nurses (17%) had no preference. Negative comments on SSD were pseudoeschar (50%), difficult application burns (25%), messiness (67%), and increased number of dressing changes (25%). Negative comments on CO were the need for an additional antimicrobial agent (58%), although 1 nurse noted the higher expense with CO. Nurses preferred CO because of cleanliness of dressing (17%), lack of pseudoeschar (25%), and less pain with dressing changes (8%). Despite no difference in outcomes between SSD and CO, experienced burn nurses prefer CO because of perceptions of decreased trauma and frequency of dressing changes.

Active sleep is associated with the face preference in the newborns who familiarized with a responsive face.

PubMed

Cecchini, Marco; Iannoni, Maria Elena; Aceto, Paola; Baroni, Eleonora; Di Vito, Cinzia; Lai, Carlo

2017-11-01

Aim of this study was to investigate the preferential looking behaviour, subsequent to a familiarization task (8-min) with a previously responsive or motionless face, before and after a sleep cycle. Moreover, the role of the active sleep in memory consolidation of the responsive or motionless faces was explored. Hypotheses were that the newborns undergoing a motionless familiarization will exhibit a novelty effect (preference for the novel face) whereas the newborns undergoing a responsive familiarization will show a familiarity effect (preference for the known face) before and after the sleep cycle; moreover, the amount of active sleep will be associated with the looking time at the known face after a sleep cycle. Forty-five healthy full-term newborns were randomly assigned to two groups (group 1: motionless-familiarization and group 2: responsive-familiarization); in both groups newborns were video-recorded during four post-familiarization face-preference tasks, two of them performed before and two after a sleep cycle. During the pre-sleep-trials, there was not a significant preference for one face in both groups. During the post-sleep trials, the newborns showed a clear preference for the novel face. This effect was more evident in group 1. Only in group 2 there was a significant positive correlation between the active sleep duration and the looking duration at the known-face during the post-sleep trials (r=0.41; p=0.040). Multiple regression confirmed that only in the group 2 the total duration of the active sleep was associated with the looking duration at the known-face during the post-sleep trials (Adjusted R 2 =0.13; β=0.41; t=2.2; p=0.040). Findings showed that in newborns the face representation can be recalled after a sleep cycle. Moreover, the amount of the active sleep predicted the post-sleep looking toward the known-face only in the newborns who interactively familiarized with the face. Copyright © 2017 Elsevier Inc. All rights reserved.

A Randomized Crossover Trial Evaluating Continuous Positive Airway Pressure Versus Mandibular Advancement Device on Health Outcomes in Veterans With Posttraumatic Stress Disorder

PubMed Central

El-Solh, Ali A.; Homish, Gregory G.; Ditursi, Guy; Lazarus, John; Rao, Nithin; Adamo, David; Kufel, Thomas

2017-01-01

Study Objectives: Despite the overall improvement in posttraumatic stress disorder (PTSD) symptomatology with continuous positive airway pressure (CPAP) therapy, adherence to CPAP is far worse in veterans with PTSD compared to the general population with obstructive sleep apnea (OSA). The aim of this study was to compare the efficacy, adherence, and preference of CPAP versus mandibular advancement device (MAD) and the effect of these treatments on health outcomes in veterans with PTSD. Methods: Forty-two subjects with PTSD and newly diagnosed OSA by polysomnography were treated in a randomized, crossover trial of 12 weeks with CPAP alternating with MAD separated by a 2-week washout period. The primary outcome was the difference in titration residual apnea-hypopnea index (AHI) between CPAP and MAD. Secondary outcome measures included PTSD Checklist and health-related quality of life (Medical Outcomes Study 36-Item Short Form and Pittsburgh Sleep Quality Index). Results: Analyses were limited to the 35 subjects (mean age 52.7 ± 11.6 years) who completed the trial, regardless of compliance with their assigned treatment. CPAP was more efficacious in reducing AHI and improving nocturnal oxygenation than MAD (P < .001 and P = .04, respectively). Both treatments reduced PTSD severity and ameliorated scores of the Medical Outcomes Study Short Form 36 and Pittsburgh Sleep Quality Index, although no differences were detected between the CPAP and MAD arms. The reported adherence to MAD was significantly higher than CPAP (P < .001), with 58% preferring MAD to CPAP. Conclusions: Although CPAP is more efficacious than MAD at improving sleep apnea, both treatment modalities imparted comparable benefits for veterans with PTSD in relation to PTSD severity and health-related quality of life. MAD offers a viable alternative for veterans with OSA and PTSD who are nonadherent to CPAP. Clinical Trial Registration: Title: A Randomized Cross Over Trial of Two Treatments for Sleep Apnea in Veterans With Post-Traumatic Stress Disorder; URL: https://www.clinicaltrials.gov/ct/show/NCT01569022; Identifier: NCT01569022 Citation: El-Solh AA, Homish GG, Ditursi G, Lazarus J, Rao N, Adamo D, Kufel T. A randomized crossover trial evaluating continuous positive airway pressure versus mandibular advancement device on health outcomes in veterans with posttraumatic stress disorder. J Clin Sleep Med. 2017;13(11):1327–1335 PMID:29065960

Strategies for Effective Eating Development-SEEDS: Design of an Obesity Prevention Program to Promote Healthy Food Preferences and Eating Self-Regulation in Children From Low-Income Families.

PubMed

Hughes, Sheryl O; Power, Thomas G; Beck, Ashley; Betz, Drew; Calodich, Shirley; Goodell, L Suzanne; Hill, Laura G; Hill, Rachael; Jaramillo, J Andrea; Johnson, Susan L; Lanigan, Jane; Lawrence, Adair; Martinez, AnaMaria Diaz; Nesbitt, Merrianneeta; Overath, Irene; Parker, Louise; Ullrich-French, Sarah

2016-06-01

To develop a scientifically based childhood obesity prevention program supporting child eating self-regulation and taste preferences. This article describes the research methods for the Strategies for Effective Eating Development program. A logic model is provided that depicts a visual presentation of the activities that will be used to guide the development of the prevention program. Randomized, controlled prevention program, pretest, posttest, 6 months, and 12 months. Two sites: Houston, TX and Pasco, WA. Each trial will last 7 weeks with 8-10 mother-child dyads in each arm (prevention and control). Recruitment at Head Start districts (Texas; n = 160) and Inspire Child Development Center including Early Childhood Education and Head Start (Washington; n = 160). Sixteen trials with 16-20 parent-child dyads per trial will provide adequate power to detect moderate effects. Multicomponent family-based prevention program incorporating a dialogue approach to adult learning and self-determination theory. Child assessments will include observed taste preferences, caloric compensation, and eating in the absence of hunger. Parent assessments will include parent-reported feeding, feeding emotions, acculturation, child eating behaviors, child food preferences, and child dietary intake. Heights and weights will be measured for parent and child. A multilevel growth modeling analysis will be employed to consider the nested nature of the data: time points (level 1) within families (level 2) within trials (level 3). Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Improving Awareness of Cancer Clinical Trials Among Hispanic Patients and Families: Audience Segmentation Decisions for a Media Intervention

PubMed Central

QUINN, GWENDOLYN P.; McINTYRE, JESSICA; GONZALEZ, LUIS E.; ANTONIA, TERESITA MUÑOZ; ANTOLINO, PRADO; WELLS, KRISTEN J.

2016-01-01

Clinical trials hold great promise for cancer treatment; yet, Hispanic cancer patients have low rates of clinical trial participation. Lack of awareness and knowledge of clinical trials and language barriers may account for low participation rates. Patient education through audiovisual materials can improve knowledge of and attitudes toward clinical trials among Hispanic populations. In this study, 36 Hispanic cancer patients/survivors and caregivers in Florida and Puerto Rico participated in focus groups to aid in developing a Spanish-language DVD and booklet intervention designed to increase knowledge about clinical trials. Focus group results showed (a) low levels of knowledge about clinical trials, (b) uncertainty about why a physician would expect a patient to make a choice about treatment, and (c) desire for family participation in decision making. Respondents expressed various preferences for aspects of the DVD such as showing extended family in the DVD and physician explanations about key terms. On the basis of these preferences, the authors developed a creative brief for a DVD. The content of the DVD was reviewed by Hispanic community leaders and key stakeholders. A final DVD was created, in Spanish, using Hispanic patients and physicians, which contained the information deemed important from the focus groups and stakeholder interviews. The DVD is complete with companion booklet and currently undergoing a randomized control trial. PMID:23639101

Self-administration of intranasal influenza vaccine: Immunogenicity and volunteer acceptance

PubMed Central

Burgess, Timothy H.; Murray, Clinton K.; Bavaro, Mary F.; Landrum, Michael L.; O’Bryan, Thomas A.; Rosas, Jessica G.; Cammarata, Stephanie M.; Martin, Nicholas J.; Ewing, Daniel; Raviprakash, Kanakatte; Mor, Deepika; Zell, Elizabeth R.; Wilkins, Kenneth J.; Millar, Eugene V.

2018-01-01

Background In outbreak settings, mass vaccination strategies could maximize health protection of military personnel. Self-administration of live attenuated influenza vaccine (LAIV) may be a means to vaccinate large numbers of people and achieve deployment readiness while sparing the use of human resources. Methods A phase IV, open-label, randomized controlled trial evaluating the immunogenicity and acceptance of self-administered (SA) LAIV was conducted from 2012 to 2014. SA subjects were randomized to either individual self-administration or self-administration in a group setting. Control randomized subjects received healthcare worker-administered (HCWA) LAIV. Anti-hemagglutinin (HAI) antibody concentrations were measured pre- and post-vaccination. The primary endpoint was immunogenicity non-inferiority between SA and HCWA groups. Subjects were surveyed on preferred administration method. Results A total of 1077 subjects consented and were randomized (529 SA, 548 HCWA). Subject characteristics were very similar between groups, though SA subjects were younger, more likely to be white and on active duty. The per-protocol analysis included 1024 subjects (501 SA, 523 HCWA). Post-vaccination geometric mean titers by vaccine strain and by study group (HCWA vs. SA) were: A/H1N1 (45.8 vs. 48.7, respectively; p = 0.43), A/H3N2 (45.5 vs. 46.4; p = 0.80), B/Yamagata (17.2 vs. 17.8; p = 0.55). Seroresponses to A components were high (∼67%), while seroresponses to B components were lower (∼25%). Seroresponse did not differ by administration method. Baseline preference for administration method was similar between groups, with the majority in each group expressing no preference. At follow-up, the majority (64%) of SA subjects preferred SA vaccine. Conclusions LAIV immunogenicity was similar for HCWA and SA vaccines. SA was well-tolerated and preferred to HCWA among those who performed SA. PMID:26117150

Guanidinoacetic acid versus creatine for improved brain and muscle creatine levels: a superiority pilot trial in healthy men.

PubMed

Ostojic, Sergej M; Ostojic, Jelena; Drid, Patrik; Vranes, Milan

2016-09-01

In this randomized, double-blind, crossover trial, we evaluated whether 4-week supplementation with guanidinoacetic acid (GAA) is superior to creatine in facilitating creatine levels in healthy men (n = 5). GAA (3.0 g/day) resulted in a more powerful rise (up to 16.2%) in tissue creatine levels in vastus medialis muscle, middle-cerebellar peduncle, and paracentral grey matter, as compared with creatine (P < 0.05). These results indicate that GAA as a preferred alternative to creatine for improved bioenergetics in energy-demanding tissues.

Evaluating the importance of sham controlled trials in the investigation of medical devices in interventional cardiology.

PubMed

Byrne, Robert A; Capodanno, Davide; Mahfoud, Felix; Fajadet, Jean; Windecker, Stephan; Jüni, Peter; Baumbach, Andreas; Wijns, William; Haude, Michael

2018-05-22

Cardiovascular medicine is one of the specialties that has relied most heavily on evidence from randomized clinical trials in determining best practice for the management of common disease conditions. When comparing treatment approaches, trials incorporating random allocation are the most appropriate method for protecting against treatment allocation bias. In order to protect against performance and ascertainment bias, trial designs including placebo control are preferable where feasible. In contrast to testing of medicines, treatments based on procedures or use of medical devices are more challenging to assess, as sham procedures are necessary to facilitate blinding of participants. However, in many cases, ethical concerns exist, as individual patients allocated to sham procedure are exposed only to risk without potential for benefit. Accordingly, the potential benefits to the general patient population must be carefully weighed against the risks of the exposed individuals. For this reason, trial design and study conduct are critically important to ensure that the investigation has the best chance of answering the study question at hand. In the current manuscript, we aim to review issues relating to the conduct of sham-controlled trials and discuss a number of recent examples in the field of interventional cardiology.

Motivation for Different Types and Doses of Exercise During Breast Cancer Chemotherapy: a Randomized Controlled Trial.

PubMed

Courneya, Kerry S; Segal, Roanne J; Vallerand, James R; Forbes, Cynthia C; Crawford, Jennifer J; Dolan, Lianne B; Friedenreich, Christine M; Reid, Robert D; Gelmon, Karen; Mackey, John R; McKenzie, Donald C

2016-08-01

Exercise is beneficial for breast cancer patients during chemotherapy, but their motivation to perform different types and doses of exercise is unknown. The purpose of this study was to examine the anticipated and experienced motivation of breast cancer patients before and after three different exercise programs during chemotherapy. Breast cancer patients initiating chemotherapy (N = 301) were randomized to a standard dose of 25-30 min of aerobic exercise, a higher dose of 50-60 min of aerobic exercise, or a combined dose of 50-60 min of aerobic and resistance exercise. Patient preference and motivational outcomes from the theory of planned behavior (i.e., perceived benefit, enjoyment, support, difficulty, and motivation) were assessed before and after the interventions. At pre-randomization, breast cancer patients were significantly (p < 0.001) more likely to prefer the combined program (80.1 %); however, after the interventions there was a significant (p < 0.001) increase in the number of patients preferring the high volume program and having no preference. At pre-randomization, breast cancer patients anticipated more favorable motivational outcomes for the combined program and less favorable motivational outcomes for the high volume program (all p < 0.001). After the interventions, the motivational outcomes experienced exceeded the anticipated motivational outcomes significantly more in the high volume group than the standard or combined groups. Anticipated motivational outcomes for different types and doses of exercise during chemotherapy varied considerably at pre-randomization, but the motivational outcomes experienced after the three interventions were similar. Clinicians can recommend any of the three exercise interventions to breast cancer patients knowing that positive motivational outcomes will result. Clinicaltrials.gov identifier: NCT00249015 .

A Randomized Controlled Trial of a Cardiopulmonary Resuscitation Video in Advance Care Planning for Progressive Pancreas and Hepatobiliary Cancer Patients

PubMed Central

Volandes, Angelo E.; Chen, Ling Y.; Gary, Kristen A.; Li, Yuelin; Agre, Patricia; Levin, Tomer T.; Reidy, Diane L.; Meng, Raymond D.; Segal, Neil H.; Yu, Kenneth H.; Abou-Alfa, Ghassan K.; Janjigian, Yelena Y.; Kelsen, David P.; O'Reilly, Eileen M.

2013-01-01

Abstract Background Cardiopulmonary resuscitation (CPR) is an important advance directive (AD) topic in patients with progressive cancer; however such discussions are challenging. Objective This study investigates whether video educational information about CPR engenders broader advance care planning (ACP) discourse. Methods Patients with progressive pancreas or hepatobiliary cancer were randomized to an educational CPR video or a similar CPR narrative. The primary end-point was the difference in ACP documentation one month posttest between arms. Secondary end-points included study impressions; pre- and post-intervention knowledge of and preferences for CPR and mechanical ventilation; and longitudinal patient outcomes. Results Fifty-six subjects were consented and analyzed. Rates of ACP documentation (either formal ADs or documented discussions) were 40% in the video arm (12/30) compared to 15% in the narrative arm (4/26), OR=3.6 [95% CI: 0.9–18.0], p=0.07. Post-intervention knowledge was higher in both arms. Posttest, preferences for CPR had changed in the video arm but not in the narrative arm. Preferences regarding mechanical ventilation did not change in either arm. The majority of subjects in both arms reported the information as helpful and comfortable to discuss, and they recommended it to others. More deaths occurred in the video arm compared to the narrative arm, and more subjects died in hospice settings in the video arm. Conclusions This pilot randomized trial addressing downstream ACP effects of video versus narrative decision tools demonstrated a trend towards more ACP documentation in video subjects. This trend, as well as other video effects, is the subject of ongoing study. PMID:23725233

The effect of music on biochemical markers and self-perceived stress among first-line nurses: a randomized controlled crossover trial.

PubMed

Lai, Hui-Ling; Li, Yin-Ming

2011-11-01

The aim of this study was to examine the effects of music on stress indices and to examine the association between music preference and stress. Although clinical studies have demonstrated the effectiveness of music on stress, study results have been inconsistent. At the time of writing, no known publications had investigated the effects of preferred music on workers in high-stress professions such as nursing. Using a randomized crossover controlled trial, 54 nurses were randomly assigned to a music/chair rest sequence or chair rest/music sequence during the period February to June 2006. Each intervention lasted for 30 minutes. Participants in the music condition listened to self-selected soothing music using headphones for 30 minutes. In the chair rest condition, participants sat quietly for 30 minutes. Serial measurements of participants' heart rate, mean arterial pressure, finger temperature and cortisol levels were taken with a BP monitor and chemillumincent immunoassay every 15 minutes throughout the procedure. Compared with chair rest, participants had a lower perceived stress level, cortisol, heart rate, mean arterial pressure and higher finger temperature while listening to music (P < 0·05). Significant differences were also found between the two conditions in terms of post-test heart rate, cortisol levels, finger temperature and mean arterial pressure (P < 0·05). Music preference scores ranged between 7 and 10, with a mean score of 8·81 (sd = 1·05), and was significantly associated with mean arterial pressure, cortisol levels, self-perceived stress and finger temperature. The findings provided evidence for nurses to use soothing music as a research-based nursing intervention for stress reduction. © 2011 The Authors. Journal of Advanced Nursing © 2011 Blackwell Publishing Ltd.


Intrathecal analgesia by bupivacaine is not enhanced by coadministration of morphine in patients with severe cancer-related pain: a randomized double-blind cross-over study.

PubMed

Reif, Ingalill; Wincent, Anders; Stiller, Carl-Olav

2017-06-01

The objective of this randomized double blind cross-over trial was to determine if patients with severe cancer-related pain and inadequate response to systemic opioids prefer intrathecal (IT) pain relief with a combination of bupivacaine and morphine or bupivacaine only. Adult patients with cancer-related pain (n = 23) scheduled for IT analgesia at the Pain Center at the Karo-linska University Hospital Solna, Stockholm, Sweden, were included. The optimal individual flow rate of IT bupivacaine (2 mg/mL) in addition to bolus doses was titrated and maintained for 4 days. Morphine (1 mg/mL) was added to bupivacaine either on day 2 or 4 according to a randomization protocol. Expression of pain relief preference for morphine instead of control (bupivacaine only) was the primary outcome. Secondary outcomes were difference in pain intensity, pain relief, total use of bupivacaine per 24 hours and number of requested bolus doses. Eight patients dropped out during the 4-day study period for reasons not related to the trial. IT bupivacaine significantly decreased median (interquartile range) pain intensity from 5 (3 - 7) at baseline (before catheter insertion) to 1 (0 - 1) (p = 0.0001; Wilcoxon test). Only 1 patient of 15 with 4-day data expressed any preference for morphine. The addition of IT morphine did not result in any significant change of pain intensity, pain relief score, total use of bupivacaine per 24 hours, or number of requested bolus doses. These results suggest that patients with cancer-related pain treated with high doses of systemic opioids, may start IT treatment with an optimal dose of IT bupivacaine without morphine.
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Considering Patient Diet Preference to Optimize Weight Loss: Design Considerations of a Randomized Trial Investigating the Impact of Choice

PubMed Central

Yancy, William S.; Coffman, Cynthia J.; Geiselman, Paula J.; Kolotkin, Ronette L.; Almirall, Daniel; Oddone, Eugene Z.; Mayer, Stephanie B.; Gaillard, Leslie A.; Turner, Marsha; Smith, Valerie A.; Voils, Corrine I.

2015-01-01

A variety of diet approaches achieve moderate weight loss in many individuals. Yet, most diet interventions fail to achieve meaningful weight loss in more than a few individuals, likely due to inadequate adherence to the diet. It is widely conjectured that targeting the diet to an individual's food preferences will enhance adherence, thereby improving weight loss. This article describes the design considerations of a study protocol aimed at testing this hypothesis. The study is a 2-arm randomized trial recruiting 216 medical outpatients with BMI ≥30 kg/m2 followed for 48 weeks. Participants in the experimental arm (Choice) select from two of the most widely studied diets for weight loss, a low-carbohydrate, calorie-unrestricted diet (LCD) or a low-fat, reduced-calorie diet (LFD). The participant's choice is informed by results from a validated food preference questionnaire and a discussion of diet options with trained personnel. Choice participants are given the option to switch to the other diet after three months, if desired. Participants in the Control arm are randomly assigned to follow one of the two diets for the duration of follow-up. The primary outcome is weight assessed every 2-4 weeks for 48 weeks. Secondary outcomes include adherence to diet by food frequency questionnaire and obesity-specific health-related quality of life. If assisting patients to choose their diet enhances adherence and increases weight loss, the results will support the provision of diet options to patients who desire weight loss, and bring us one step closer to remediating the obesity epidemic faced by our healthcare systems. PMID:23506974

Visual systemizing preference in children with autism: A randomized controlled trial of intranasal oxytocin.

PubMed

Strathearn, Lane; Kim, Sohye; Bastian, D Anthony; Jung, Jennifer; Iyengar, Udita; Martinez, Sheila; Goin-Kochel, Robin P; Fonagy, Peter

2018-05-01

Several studies have suggested that the neuropeptide oxytocin may enhance aspects of social communication in autism. Little is known, however, about its effects on nonsocial manifestations, such as restricted interests and repetitive behaviors. In the empathizing-systemizing theory of autism, social deficits are described along the continuum of empathizing ability, whereas nonsocial aspects are characterized in terms of an increased preference for patterned or rule-based systems, called systemizing. We therefore developed an automated eye-tracking task to test whether children and adolescents with autism spectrum disorder (ASD) compared to matched controls display a visual preference for more highly organized and structured (systemized) real-life images. Then, as part of a randomized, double-blind, placebo-controlled crossover study, we examined the effect of intranasal oxytocin on systemizing preferences in 16 male children with ASD, compared with 16 matched controls. Participants viewed 14 slides, each containing four related pictures (e.g., of people, animals, scenes, or objects) that differed primarily on the degree of systemizing. Visual systemizing preference was defined in terms of the fixation time and count for each image. Unlike control subjects who showed no gaze preference, individuals with ASD preferred to fixate on more highly systemized pictures. Intranasal oxytocin eliminated this preference in ASD participants, who now showed a similar response to control subjects on placebo. In contrast, control participants increased their visual preference for more systemized images after receiving oxytocin versus placebo. These results suggest that, in addition to its effects on social communication, oxytocin may play a role in some of the nonsocial manifestations of autism.

Food preferences and weight change during low-fat and low-carbohydrate diets

PubMed Central

McVay, Megan A.; Voils, Corrine I.; Geiselman, Paula J.; Smith, Valerie A.; Coffman, Cynthia J.; Mayer, Stephanie; Yancy, William S.

2016-01-01

Understanding associations between food preferences and weight loss during various effective diets could inform efforts to personalize dietary recommendations and provide insight into weight loss mechanisms. We conducted a secondary analysis of data from a clinical trial in which participants were randomized to either a ‘choice’ arm, in which they were allowed to select between a low-fat diet (n=44) or low-carbohydrate diet (n=61), or to a ‘no choice’ arm, in which they were randomly assigned to a low-fat diet (n=49) or low-carbohydrate diet (n=53). All participants were provided 48 weeks of lifestyle counseling. Food preferences were measured at baseline and every 12 weeks thereafter with the Geiselman Food Preference Questionnaire. Participants were 73% male and 51% African American, with a mean age of 55. Baseline food preferences, including congruency of food preferences with diet, were not associated with weight outcomes. In the low-fat diet group, no associations were found between changes in food preferences and weight over time. In the low-carbohydrate diet group, increased preference for low-carbohydrate diet congruent foods from baseline to 12 weeks was associated with weight loss from 12 to 24 weeks. Additionally, weight loss from baseline to 12 weeks was associated with increased preference for low-carbohydrate diet congruent foods from 12 to 24 weeks. Results suggest that basing selection of low-carbohydrate diet or low-fat diet on food preferences is unlikely to influence weight loss. Congruency of food preferences and weight loss may influence each other early during a low-carbohydrate diet but not low-fat diet, possibly due to different features of these diets. PMID:27133551

Effect of Dilute Apple Juice and Preferred Fluids vs Electrolyte Maintenance Solution on Treatment Failure Among Children With Mild Gastroenteritis: A Randomized Clinical Trial.

PubMed

Freedman, Stephen B; Willan, Andrew R; Boutis, Kathy; Schuh, Suzanne

2016-05-10

Gastroenteritis is a common pediatric illness. Electrolyte maintenance solution is recommended to treat and prevent dehydration. Its advantage in minimally dehydrated children is unproven. To determine if oral hydration with dilute apple juice/preferred fluids is noninferior to electrolyte maintenance solution in children with mild gastroenteritis. Randomized, single-blind noninferiority trial conducted between the months of October and April during the years 2010 to 2015 in a tertiary care pediatric emergency department in Toronto, Ontario, Canada. Study participants were children aged 6 to 60 months with gastroenteritis and minimal dehydration. Participants were randomly assigned to receive color-matched half-strength apple juice/preferred fluids (n=323) or apple-flavored electrolyte maintenance solution (n=324). Oral rehydration therapy followed institutional protocols. After discharge, the half-strength apple juice/preferred fluids group was administered fluids as desired; the electrolyte maintenance solution group replaced losses with electrolyte maintenance solution. The primary outcome was a composite of treatment failure defined by any of the following occurring within 7 days of enrollment: intravenous rehydration, hospitalization, subsequent unscheduled physician encounter, protracted symptoms, crossover, and 3% or more weight loss or significant dehydration at in-person follow-up. Secondary outcomes included intravenous rehydration, hospitalization, and frequency of diarrhea and vomiting. The noninferiority margin was defined as a difference between groups of 7.5% for the primary outcome and was assessed with a 1-sided α=.025. If noninferiority was established, a 1-sided test for superiority was conducted. Among 647 randomized children (mean age, 28.3 months; 331 boys [51.1%]; 441 (68.2%) without evidence of dehydration), 644 (99.5%) completed follow-up. Children who were administered dilute apple juice experienced treatment failure less often than those given electrolyte maintenance solution (16.7% vs 25.0%; difference, -8.3%; 97.5% CI, -∞ to -2.0%; P < .001 for inferiority and P = .006 for superiority). Fewer children administered apple juice/preferred fluids received intravenous rehydration (2.5% vs 9.0%; difference, -6.5%; 99% CI, -11.6% to -1.8%). Hospitalization rates and diarrhea and vomiting frequency were not significantly different between groups. Among children with mild gastroenteritis and minimal dehydration, initial oral hydration with dilute apple juice followed by their preferred fluids, compared with electrolyte maintenance solution, resulted in fewer treatment failures. In many high-income countries, the use of dilute apple juice and preferred fluids as desired may be an appropriate alternative to electrolyte maintenance fluids in children with mild gastroenteritis and minimal dehydration. clinicaltrials.gov Identifier: NCT01185054.

Patient representatives' views on patient information in clinical cancer trials.

PubMed

Dellson, Pia; Nilbert, Mef; Carlsson, Christina

2016-02-01

Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials. Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I-III trials, randomized and non-randomized trials that evaluated chemotherapy/targeted therapy in the neoadjuvant, adjuvant and palliative settings. Data were collected through focus groups and were analysed using inductive content analysis. Two major themes emerged: emotional responses and cognitive responses. Subthemes related to the former included individual preferences and perceptions of effect, while subthemes related to the latter were comprehensibility and layout. Based on these observations the patient representatives provided suggestions for improvement, which largely included development of future simplified and more attractive informed consent forms. The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language, structured text and illustrations to improve the informed consent process and thereby patient enrolment into clinical trials.

Oncology Communication Skills Training: Bringing Science to the Art of Delivering Bad News

PubMed Central

Stovall, Mady C.

2015-01-01

Review of "Effect of communication skills training program for oncologists based on patient preferences for communication when receiving bad news: A randomized controlled trial" by Fujimori et al. (2014), Journal of Clinical Oncology, 32, 2166–2172. For a further discussion of survey research, please see the related article by Julie Ponto starting on page 168. PMID:26649249

Oncology Communication Skills Training: Bringing Science to the Art of Delivering Bad News.

PubMed

Stovall, Mady C

2015-01-01

Review of "Effect of communication skills training program for oncologists based on patient preferences for communication when receiving bad news: A randomized controlled trial" by Fujimori et al. (2014), Journal of Clinical Oncology, 32, 2166-2172. For a further discussion of survey research, please see the related article by Julie Ponto starting on page 168.

Logistic random effects regression models: a comparison of statistical packages for binary and ordinal outcomes.

PubMed

Li, Baoyue; Lingsma, Hester F; Steyerberg, Ewout W; Lesaffre, Emmanuel

2011-05-23

Logistic random effects models are a popular tool to analyze multilevel also called hierarchical data with a binary or ordinal outcome. Here, we aim to compare different statistical software implementations of these models. We used individual patient data from 8509 patients in 231 centers with moderate and severe Traumatic Brain Injury (TBI) enrolled in eight Randomized Controlled Trials (RCTs) and three observational studies. We fitted logistic random effects regression models with the 5-point Glasgow Outcome Scale (GOS) as outcome, both dichotomized as well as ordinal, with center and/or trial as random effects, and as covariates age, motor score, pupil reactivity or trial. We then compared the implementations of frequentist and Bayesian methods to estimate the fixed and random effects. Frequentist approaches included R (lme4), Stata (GLLAMM), SAS (GLIMMIX and NLMIXED), MLwiN ([R]IGLS) and MIXOR, Bayesian approaches included WinBUGS, MLwiN (MCMC), R package MCMCglmm and SAS experimental procedure MCMC.Three data sets (the full data set and two sub-datasets) were analysed using basically two logistic random effects models with either one random effect for the center or two random effects for center and trial. For the ordinal outcome in the full data set also a proportional odds model with a random center effect was fitted. The packages gave similar parameter estimates for both the fixed and random effects and for the binary (and ordinal) models for the main study and when based on a relatively large number of level-1 (patient level) data compared to the number of level-2 (hospital level) data. However, when based on relatively sparse data set, i.e. when the numbers of level-1 and level-2 data units were about the same, the frequentist and Bayesian approaches showed somewhat different results. The software implementations differ considerably in flexibility, computation time, and usability. There are also differences in the availability of additional tools for model evaluation, such as diagnostic plots. The experimental SAS (version 9.2) procedure MCMC appeared to be inefficient. On relatively large data sets, the different software implementations of logistic random effects regression models produced similar results. Thus, for a large data set there seems to be no explicit preference (of course if there is no preference from a philosophical point of view) for either a frequentist or Bayesian approach (if based on vague priors). The choice for a particular implementation may largely depend on the desired flexibility, and the usability of the package. For small data sets the random effects variances are difficult to estimate. In the frequentist approaches the MLE of this variance was often estimated zero with a standard error that is either zero or could not be determined, while for Bayesian methods the estimates could depend on the chosen "non-informative" prior of the variance parameter. The starting value for the variance parameter may be also critical for the convergence of the Markov chain.

Promoting advance care planning among community-based older adults: A randomized controlled trial.

PubMed

Bravo, Gina; Trottier, Lise; Arcand, Marcel; Boire-Lavigne, Anne-Marie; Blanchette, Danièle; Dubois, Marie-France; Guay, Maryse; Lane, Julie; Hottin, Paule; Bellemare, Suzanne

2016-11-01

To test an intervention designed to motivate older adults in documenting their healthcare preferences in advance, and to guide proxies in making hypothetical decisions that match those of the older adult. The trial involved 235 older adults, of which half were assisted in communicating their wishes to their proxy. Hypothetical vignettes were used at baseline and twice after the intervention to elicit older adults' preferences and assess their proxy's ability to predict them. By the end of the trial, 80% of older adults allocated to the experimental group had documented their wishes. Changes over time in mean accuracy scores did not differ between groups for any hypothetical situations, except when limiting the sample to dyads that were highly discordant at baseline. The intervention motivated a large proportion of older adults to express their preferences but had little effect on proxies' ability to predict them. Educational tools developed for this study will assist healthcare providers in helping older adults to record their wishes in advance. Clients must be informed of the challenge of making substitute decisions and of the need to discuss the amount of leeway the proxy should have in interpreting expressed wishes. Copyright © 2016 The Author(s). Published by Elsevier Ireland Ltd.. All rights reserved.

Biomechanical characteristics, patient preference and activity level with different prosthetic feet: a randomized double blind trial with laboratory and community testing.

PubMed

Raschke, Silvia U; Orendurff, Michael S; Mattie, Johanne L; Kenyon, David E A; Jones, O Yvette; Moe, David; Winder, Lorne; Wong, Angie S; Moreno-Hernández, Ana; Highsmith, M Jason; J Sanderson, David; Kobayashi, Toshiki

2015-01-02

Providing appropriate prosthetic feet to those with limb loss is a complex and subjective process influenced by professional judgment and payer guidelines. This study used a small load cell (Europa™) at the base of the socket to measure the sagittal moments during walking with three objective categories of prosthetic feet in eleven individuals with transtibial limb loss with MFCL K2, K3 and K4 functional levels. Forefoot stiffness and hysteresis characteristics defined the three foot categories: Stiff, Intermediate, and Compliant. Prosthetic feet were randomly assigned and blinded from participants and investigators. After laboratory testing, participants completed one week community wear tests followed by a modified prosthetics evaluation questionnaire to determine if a specific category of prosthetic feet was preferred. The Compliant category of prosthetic feet was preferred by the participants (P=0.025) over the Stiff and Intermediate prosthetic feet, and the Compliant and Intermediate feet had 15% lower maximum sagittal moments during walking in the laboratory (P=0.0011) compared to the Stiff feet. The activity level of the participants did not change significantly with any of the wear tests in the community, suggesting that each foot was evaluated over a similar number of steps, but did not inherently increase activity. This is the first randomized double blind study in which prosthetic users have expressed a preference for a specific biomechanical characteristic of prosthetic feet: those with lower peak sagittal moments were preferred, and specifically preferred on slopes, stairs, uneven terrain, and during turns and maneuvering during real world use. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Is there a role for physician involvement in introducing research to surrogate decision makers in the intensive care unit? (The Approach trial: a pilot mixed methods study).

PubMed

Burns, K E A; Rizvi, L; Smith, O M; Lee, Y; Lee, J; Wang, M; Brown, M; Parker, M; Premji, A; Leung, D; Hammond Mobilio, M; Gotlib-Conn, L; Nisenbaum, R; Santos, M; Li, Y; Mehta, S

2015-01-01

To assess the feasibility of conducting a randomized trial comparing two strategies [physician (MD) vs. non-physician (non-MD)] for approaching substitute decision makers (SDMs) for research and to evaluate SDMs' experiences in being approached for consent. A pilot mixed methods study of first encounters with SDMs. Of 137 SDMs (162 eligibility events), 67 and 70 were randomized to MD and non-MD introductions, respectively. Eighty SDMs (98 events) provided consent and 21 SDMs (24 events) declined consent for studies, including 2 SDMs who provided and declined consent. We identified few missed introductions [4/52 (7.7 %)] and protocol violations [6/117 (5.1 %)], high comfort, satisfaction and acceptance scores and similar consent rates in both arms. SDMs provided consent significantly more often when a patient update was provided in the MD arm. Most SDMs (85.7 %) felt that physician involvement was inconsequential and preferred physician time to be dedicated to patient care; however, SDM experiences were closely related to their recall of being approached and recall was poor. SDMs highlighted 7 themes of importance to them in research surrogate decision-making. SDMs prioritized the personal attributes of the person approaching them over professional designation and preferred physician time to be dedicated to patient care. A mixed methods design evaluated intervention fidelity and provided the rationale for not proceeding to a larger trial, despite achieving all feasibility metrics in the pilot trial. NCT01232621.

Cost-effectiveness of antibiotic treatment strategies for community-acquired pneumonia: results from a cluster randomized cross-over trial.

PubMed

van Werkhoven, Cornelis H; Postma, Douwe F; Mangen, Marie-Josee J; Oosterheert, Jan Jelrik; Bonten, Marc J M

2017-01-10

To determine the cost-effectiveness of strategies of preferred antibiotic treatment with beta-lactam/macrolide combination or fluoroquinolone monotherapy compared to beta-lactam monotherapy. Costs and effects were estimated using data from a cluster-randomized cross-over trial of antibiotic treatment strategies, primarily from the reduced third payer perspective (i.e. hospital admission costs). Cost-minimization analysis (CMA) and cost-effectiveness analysis (CEA) were performed using linear mixed models. CMA results were expressed as difference in costs per patient. CEA results were expressed as incremental cost-effectiveness ratios (ICER) showing additional costs per prevented death. A total of 2,283 patients were included. Crude average costs within 90 days from the reduced third payer perspective were €4,294, €4,392, and €4,002 per patient for the beta-lactam monotherapy, beta-lactam/macrolide combination, and fluoroquinolone monotherapy strategy, respectively. CMA results were €106 (95% CI €-697 to €754) for the beta-lactam/macrolide combination strategy and €-278 (95%CI €-991 to €396) for the fluoroquinolone monotherapy strategy, both compared to the beta-lactam monotherapy strategy. The ICER was not statistically significantly different between the strategies. Other perspectives yielded similar results. There were no significant differences in cost-effectiveness of strategies of preferred antibiotic treatment of CAP on non-ICU wards with either beta-lactam monotherapy, beta-lactam/macrolide combination therapy, or fluoroquinolone monotherapy. The trial was registered with ClinicalTrials.gov, number NCT01660204 , on May 2nd, 2012.

Commentary on: "Randomized, controlled, double-blind, cross-over trial assessing treatment preference for pazopanib versus sunitinib in patients with metastatic renal cell carcinoma: PISCES study." Escudier B, Porta C, Bono P, Powles T, Eisen T, Sternberg CN, Gschwend JE, De Giorgi U, Parikh O, Hawkins R, Sevin E, Négrier S, Khan S, Diaz J, Redhu S, Mehmud F, Cella D. Bernard Escudier, Institut Gustave Roussy, Villejuif; Emmanuel Sevin, Centre François Baclesse, Caen; Sylvie Négrier, Leon Berard Cancer Center, Lyon, France; Camillo Porta, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico S. Matteo, Pavia; Cora N Sternberg, San Camillo Forlanini Hospital, Rome; Ugo De Giorgi, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; Petri Bono, Helsinki University Central Hospital, Helsinki, Finland; Thomas Powles, Barts Experimental Cancer Medicine Centre, Barts Cancer Institute, Queen Mary University of London, London; Tim Eisen, Cambridge University Health Partners, Cambridge; Omi Parikh, Royal Preston Hospital, Lancashire; Robert Hawkins, Christie Cancer Research UK, Manchester; Sadya Khan, Jose Diaz, and Faisal Mehmud, GlaxoSmithKline, Uxbridge, United Kingdom; Jürgen E Gschwend, Klinikum Rechts der Isar der Technischen Universität München, Munich, Germany; Suman Redhu, GlaxoSmithKline, Collegeville, PA; David Cella, Northwestern University Feinberg School of Medicine, Chicago, IL.: J Clin Oncol. 2014 May 10;32(14):1412-1418; doi: 10.1200/JCO.2013.50.8267. [Epub 2014 Mar 31].

PubMed

Trump, Donald

2016-05-01

Patient-reported outcomes may help inform treatment choice in advanced/metastatic renal cell carcinoma (RCC), particularly between approved targeted therapies with similar efficacy. This double-blind crossover study evaluated patient preference for pazopanib or sunitinib and the influence of health-related quality of life (HRQoL) and safety factors on their stated preference. Patients with metastatic renal cell carcinoma were randomly assigned to pazopanib 800mg per day for 10 weeks, a 2-week washout, and then sunitinib 50mg per day (4 weeks on, 2 weeks off, 4weeks on) for 10 weeks, or the reverse sequence. The primary end point, patient preference for a specific treatment, was assessed by questionnaire at the end of the two treatment periods. Other end points and analyses included reasons for preference, physician preference, safety, and HRQoL. Of 169 randomly assigned patients, 114 met the following prespecified modified intent-to-treat criteria for the primary analysis: exposure to both treatments, no disease progression before cross over, and completion of the preference questionnaire. Significantly more patients preferred pazopanib (70%) over sunitinib (22%); 8% expressed no preference (P<.001). All preplanned sensitivity analyses, including the intent-to-treat population, statistically favored pazopanib. Less fatigue and better overall quality of life were the main reasons for preferring pazopanib, with less diarrhea being the most cited reason for preferring sunitinib. Physicians also preferred pazopanib (61%) over sunitinib (22%); 17% expressed no preference. Adverse events were consistent with each drug׳s known profile. Pazopanib was superior to sunitinib in HRQoL measures evaluating fatigue, hand/foot soreness, and mouth/throat soreness. This innovative crossover trial demonstrated a significant patient preference for pazopanib over sunitinib, with HRQoL and safety as key influencing factors. Copyright © 2016 Elsevier Inc. All rights reserved.

Colorectal surgery patients prefer simple solid foods to clear fluids as the first postoperative meal.

PubMed

Yeung, Sophia E; Fenton, Tanis R

2009-09-01

Randomized controlled trials have established that there is no benefit to withholding oral food and fluids from colorectal surgery patients postoperatively. The aim of this survey was to determine food preferences for the first postoperative meal and compare these with a traditional clear-fluid diet. One hundred forty-five elective colorectal surgery patients were surveyed about their preferences for 35 common foods within 72 hours of surgery and their levels of nausea, hunger, and pain. Preferences were examined by postoperative day (one vs. two) and levels of nausea, hunger, and pain. The survey showed that patients significantly preferred solid foods as early as the first postoperative day and their preferences had little congruency with the traditional clear-fluid diet. Foods highest in preference, such as eggs, regular broth soup (e.g., chicken noodle soup), toast, and potatoes, were significantly more preferred than common clear-fluid diet items such as gelatin, clear broth, and carbonated beverages (P < 0.01). Oral supplements were preferred by only 44%. Patients reported low levels of nausea, hunger, and pain. Postoperative colorectal surgery patients prefer to receive simple solid foods rather than a clear-fluid diet as their first postoperative meal.

Smartphone Applications for Promoting Healthy Diet and Nutrition: A Literature Review.

PubMed

Coughlin, Steven S; Whitehead, Mary; Sheats, Joyce Q; Mastromonico, Jeff; Hardy, Dale; Smith, Selina A

Rapid developments in technology have encouraged the use of smartphones in health promotion research and practice. Although many applications (apps) relating to diet and nutrition are available from major smartphone platforms, relatively few have been tested in research studies in order to determine their effectiveness in promoting health. In this article, we summarize data on the use of smartphone applications for promoting healthy diet and nutrition based upon bibliographic searches in PubMed and CINAHL with relevant search terms pertaining to diet, nutrition, and weight loss through August 2015. A total of 193 articles were identified in the bibliographic searches. By screening abstracts or full-text articles, a total of three relevant qualitative studies and 9 randomized controlled trials were identified. In qualitative studies, participants preferred applications that were quick and easy to administer, and those that increase awareness of food intake and weight management. In randomized trials, the use of smartphone apps was associated with better dietary compliance for lower calorie, low fat, and high fiber foods, and higher physical activity levels (p=0.01-0.02) which resulted in more weight loss (p=0.042-<0.0001). Future studies should utilize randomized controlled trial research designs, larger sample sizes, and longer study periods to better establish the diet and nutrition intervention capabilities of smartphones. There is a need for culturally appropriate, tailored health messages to increase knowledge and awareness of health behaviors such as healthy eating. Smartphone apps are likely to be a useful and low-cost intervention for improving diet and nutrition and addressing obesity in the general population. Participants prefer applications that are quick and easy to administer and those that increase awareness of food intake and weight management.

Smartphone Applications for Promoting Healthy Diet and Nutrition: A Literature Review

PubMed Central

Coughlin, Steven S.; Whitehead, Mary; Sheats, Joyce Q.; Mastromonico, Jeff; Hardy, Dale; Smith, Selina A.

2015-01-01

Background Rapid developments in technology have encouraged the use of smartphones in health promotion research and practice. Although many applications (apps) relating to diet and nutrition are available from major smartphone platforms, relatively few have been tested in research studies in order to determine their effectiveness in promoting health. Methods In this article, we summarize data on the use of smartphone applications for promoting healthy diet and nutrition based upon bibliographic searches in PubMed and CINAHL with relevant search terms pertaining to diet, nutrition, and weight loss through August 2015. Results A total of 193 articles were identified in the bibliographic searches. By screening abstracts or full-text articles, a total of three relevant qualitative studies and 9 randomized controlled trials were identified. In qualitative studies, participants preferred applications that were quick and easy to administer, and those that increase awareness of food intake and weight management. In randomized trials, the use of smartphone apps was associated with better dietary compliance for lower calorie, low fat, and high fiber foods, and higher physical activity levels (p=0.01-0.02) which resulted in more weight loss (p=0.042-<0.0001). Discussion Future studies should utilize randomized controlled trial research designs, larger sample sizes, and longer study periods to better establish the diet and nutrition intervention capabilities of smartphones. There is a need for culturally appropriate, tailored health messages to increase knowledge and awareness of health behaviors such as healthy eating. Smartphone apps are likely to be a useful and low-cost intervention for improving diet and nutrition and addressing obesity in the general population. Participants prefer applications that are quick and easy to administer and those that increase awareness of food intake and weight management. PMID:26819969

ProCare Trial: a phase II randomized controlled trial of shared care for follow-up of men with prostate cancer.

PubMed

Emery, Jon D; Jefford, Michael; King, Madeleine; Hayne, Dickon; Martin, Andrew; Doorey, Juanita; Hyatt, Amelia; Habgood, Emily; Lim, Tee; Hawks, Cynthia; Pirotta, Marie; Trevena, Lyndal; Schofield, Penelope

2017-03-01

To test the feasibility and efficacy of a multifaceted model of shared care for men after completion of treatment for prostate cancer. Men who had completed treatment for low- to moderate-risk prostate cancer within the previous 8 weeks were eligible. Participants were randomized to usual care or shared care. Shared care entailed substituting two hospital visits with three visits in primary care, a survivorship care plan, recall and reminders, and screening for distress and unmet needs. Outcome measures included psychological distress, prostate cancer-specific quality of life, satisfaction and preferences for care and healthcare resource use. A total of 88 men were randomized (shared care n = 45; usual care n = 43). There were no clinically important or statistically significant differences between groups with regard to distress, prostate cancer-specific quality of life or satisfaction with care. At the end of the trial, men in the intervention group were significantly more likely to prefer a shared care model to hospital follow-up than those in the control group (intervention 63% vs control 24%; P<0.001). There was high compliance with prostate-specific antigen monitoring in both groups. The shared care model was cheaper than usual care (shared care AUS$1411; usual care AUS$1728; difference AUS$323 [plausible range AUS$91-554]). Well-structured shared care for men with low- to moderate-risk prostate cancer is feasible and appears to produce clinically similar outcomes to those of standard care, at a lower cost. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

A randomized controlled trial of cognitive behavioral therapy (CBT) for adjusting to multiple sclerosis (the saMS trial): does CBT work and for whom does it work?

PubMed

Moss-Morris, Rona; Dennison, Laura; Landau, Sabine; Yardley, Lucy; Silber, Eli; Chalder, Trudie

2013-04-01

The aims were (a) to test the effectiveness of a nurse-led cognitive behavioral therapy (CBT) program to assist adjustment in the early stages of multiple sclerosis (MS) and (b) to determine moderators of treatment including baseline distress, social support (SS), and treatment preference. Ninety-four ambulatory people with MS within 10 years of diagnosis were randomized to receive 8 individual sessions of CBT (n = 48) or supportive listening (n = 46), most delivered on the telephone, in a multicenter randomized controlled trial. The primary outcomes were distress and functional impairment. Secondary outcomes included global improvement, acceptance of illness, and dysfunctional cognitions. Assessments were completed at home and were coordinated by a blind assessor. Data were analyzed by intention-to-treat using multilevel models. The CBT group was significantly less distressed at the end of treatment (estimated General Health Questionnaire group difference = 3.2 points, 95\\% CI 1.1 to 5.4 points) and at the 12-month follow-up (estimated group difference = 2.2 points, 95\\% CI 0.01 to 4.4 points). There were no differences between the groups on functional impairment. The CBT group also demonstrated significantly greater improvements on secondary outcomes at the end of treatment but not at the 12-month follow-up. CBT participants with poor SS and/or clinically defined levels of distress at baseline showed significantly greater gains on both primary outcomes. Treatment preference did not moderate treatment effects. CBT is more effective than supportive listening in reducing distress in people with MS. CBT appears most effective for patients with poor SS and high levels of distress. The loss of gains in the secondary outcomes by 12 months suggests further follow-up sessions may be warranted.

Effects of active/passive interventions on pain, anxiety, and quality of life in women with fibromyalgia: Randomized controlled pilot trial.

PubMed

Ekici, Gamze; Unal, Edibe; Akbayrak, Turkan; Vardar-Yagli, Naciye; Yakut, Yavuz; Karabulut, Erdem

2017-01-01

The authors of this study compared the effects of pilates exercises and connective tissue massage (CTM) on pain intensity; pain-pressure threshold; and tolerance, anxiety, progress, and health-related quality of life in females with fibromyalgia. It was a pilot, assessor masked, randomized controlled trial conducted between January and August of 2013. Twenty-one women with fibromyalgia were randomly assigned to the pilates exercise program (six of whom did not complete the program), and 22 were randomly assigned to CTM (one of whom did not complete this program). Each group received the assigned intervention three times per week during a 4-week period. The Visual Analogue Scale, algometry, State-Trait Anxiety Inventory, Fibromyalgia Impact Questionnaire, and Nottingham Health Profile were used at baseline and at the end of treatments. Significant improvements were found in both groups for all parameters. However, the scores for pain-pressure threshold were significantly elevated and the symptoms of anxiety were significantly diminished in the exercise group compared to the massage group. Thus, exercise and massage might be used to provide improvements in women with fibromyalgia. The exercise group showed more advantages than the massage group and thus might be preferred for patients with fibromyalgia. However, an adequately powered trial is required to determine this with certainty.

Attrition during a randomized controlled trial of reduced nicotine content cigarettes as a proxy for understanding acceptability of nicotine product standards

PubMed Central

Mercincavage, Melissa; Wileyto, E. Paul; Saddleson, Megan L.; Lochbuehler, Kirsten; Donny, Eric C.; Strasser, Andrew A.

2017-01-01

Aims To determine (1) if nicotine content affects study attrition – a potential behavioral measure of acceptability – in a trial that required compliance with three levels of reduced nicotine content (RNC) cigarettes, and (2) if attrition is associated with subjective and behavioral responses to RNC cigarettes. Design Secondary analysis of a 35-day, parallel design, open-label, randomized controlled trial. After a 5-day baseline period, participants were randomized to smoke for three, 10-day periods: their preferred brand (control group), or RNC cigarettes with three nicotine levels in a within-subject, stepdown (1 group: high-moderate-low) or non-stepdown (5 groups: high-low-moderate, low-moderate-high, low-high-moderate, moderate-low-high, moderate-high-low) fashion. Setting A single site in Philadelphia, Pennsylvania, USA. Participants 246 non-treatment-seeking daily smokers (M age = 39.52, CPD = 20.95, 68.3% White) were recruited from October 2007 to June 2013. Measurements The primary outcome was attrition. Key predictors were nicotine content transition and study period. Exploratory predictors were taste and strength subjective ratings, total puff volume, and carbon monoxide (CO) boost. Covariates included: age, gender, race, education, and nicotine dependence. Findings Overall attrition was 31.3% (n = 77): 24.1% of the control and 25.0% of the stepdown RNC cigarette groups dropped out vs. 44.6% of non-stepdown groups (p = 0.006). Compared with controls, attrition odds were 4.5 and 4.7 times greater among smokers transitioning from preferred and the highest RNC cigarettes to the lowest RNC cigarettes, respectively (p’s = .001 and .003). Providing more favorable initial taste ratings of study cigarettes decreased attrition odds by 2% (p = .012). Conclusions The majority of participants completed a 35-day trial of varying levels of reduced nicotine content cigarettes. Participant drop-out was greater for cigarettes with lower nicotine content and less in smokers reporting more favorable subjective ratings of the cigarettes. PMID:28107596

Impact of advance care planning on the care of patients with heart failure: study protocol for a randomized controlled trial.

PubMed

Malhotra, Chetna; Sim, David Kheng Leng; Jaufeerally, Fazlur; Vikas, Nivedita Nadkarni; Sim, Genevieve Wong Cheng; Tan, Boon Cheng; Ng, Clarice Shu Hwa; Tho, Pei Leng; Lim, Jingfen; Chuang, Claire Ya-Ting; Fong, Florence Hui Mei; Liu, Joy; Finkelstein, Eric A

2016-06-10

Despite the promise and popularity of advance care planning, there is insufficient evidence that advance care planning helps patients to meet their end-of-life care preferences, especially in Asian settings. Thus, the proposed study aims to assess whether patients with advanced heart failure who are receiving advance care planning have a greater likelihood of receiving end-of-life care consistent with their preferences compared to patients receiving usual care. Secondary objectives are to compare differences in health care expenditures, quality of life, anxiety and depression, understanding of own illness, participation in decision-making and concordance with their caregiver's preferences for end-of-life care, between patients with advanced heart failure receiving advance care planning and usual care. This is a two-arm randomized controlled trial of advance care planning versus usual care (control) conducted at two institutions in Singapore. Two hundred and eighty-two patients with advanced heart failure (n = 94 in the advance care planning arm; n = 188 in the control arm receiving usual care) will be recruited from these centers and followed for 1 year or until they die, whichever is earlier. Additionally, the study will include up to one caregiver per patient enrolled. If advance care planning is proven to be effective, the results will help to promote its uptake among health care providers and patients both within Singapore and in other countries. NCT02299180 . Registered on 18 November 2014.

Preference for gel over suppository as delivery vehicle for a rectal microbicide: Results of a randomized, crossover acceptability trial among men who have sex with men

PubMed Central

Carballo-Diéguez, A.; Dolezal, C.; Bauermeister, J.A.; O’Brien, B.; Ventuneac, A.; Mayer, K.

2009-01-01

Objective To assess whether men who have sex with men (MSM) prefer a gel or a suppository as a delivery vehicle for a rectal microbicide. Methods 77 HIV-negative MSM with recent history of inconsistent condom use during receptive anal intercourse (RAI) who acknowledged being at risk of contracting HIV were enrolled in a randomized, crossover acceptability trial. They compared 35 ml of placebo gel with 8 g placebo rectal suppositories used in up to three RAI occasions each. Results Participants preferred the gel over the suppository (75% vs. 25%, p <.001), and so did their partners (71% vs. 29%, p <.001). The gel received more favorable ratings overall and on attributes such as color, smell, consistency, feeling in rectum immediately after insertion and/or 30 minutes after insertion, and application process. The gel resulted in less negative ratings in terms of participants being bothered by leakage, soiling, bloating, gassiness, stomach cramps, urge to have bowel movement, diarrhea, pain or trauma. Participants liked the gel more in terms of feelings during anal sex, sexual satisfaction, partners’ sexual satisfaction, and liking the product when condoms were used and when condoms were not used. Conclusions In this sample taken from one of the populations most likely to benefit from rectal microbicide availability, gel had higher acceptability than suppository as a potential microbicide vehicle. PMID:19028952

Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial.

PubMed

Koeneman, M M; Kruse, A J; Kooreman, L F S; Zur Hausen, A; Hopman, A H N; Sep, S J S; Van Gorp, T; Slangen, B F M; van Beekhuizen, H J; van de Sande, A J M; Gerestein, C G; Nijman, H W; Kruitwagen, R F P M

2017-02-07

The "TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia" (TOPIC) trial was stopped preliminary, due to lagging inclusions. This study aimed to evaluate the treatment efficacy and clinical applicability of imiquimod 5% cream in high-grade cervical intraepithelial neoplasia (CIN). The lagging inclusions were mainly due to a strong patient preference for either of the two treatment modalities. This prompted us to initiate a new study on the same subject, with a non-randomized, open-label design: the 'TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC)-3' study. Original TOPIC-trial: Medical Ethics Committee approval number METC13231; ClinicalTrials.gov Identifier: NCT02329171, 22 December 2014. TOPIC-3 study: Medical Ethics Committee approval number METC162025; ClinicalTrials.gov Identifier: NCT02917746, 16 September 2016.

Dacron® vs. PTFE as bypass materials in peripheral vascular surgery – systematic review and meta-analysis

PubMed Central

Roll, Stephanie; Müller-Nordhorn, Jacqueline; Keil, Thomas; Scholz, Hans; Eidt, Daniela; Greiner, Wolfgang; Willich, Stefan N

2008-01-01

Background In peripheral vascular bypass surgery different synthetic materials are available for bypass grafting. It is unclear which of the two commonly used materials, polytetrafluoroethylene (PTFE) or polyester (Dacron®) grafts, is to be preferred. Thus, the aim of this meta-analysis and systematic review was to compare the effectiveness of these two prosthetic bypass materials (Dacron® and PTFE). Methods We performed a systematic literature search in MEDLINE, Cochrane-Library – CENTRAL, EMBASE and other databases for relevant publications in English and German published between 1999 and 2008. Only randomized controlled trials were considered for inclusion. We assessed the methodological quality by means of standardized checklists. Primary patency was used as the main endpoint. Random-effect meta-analysis as well as pooling data in life table format was performed to combine study results. Results Nine randomized controlled trials (RCT) were included. Two trials showed statistically significant differences in primary patency, one favouring Dacron® and one favouring PTFE grafts, while 7 trials did not show statistically significant differences between the two materials. Meta-analysis on the comparison of PTFE vs. Dacron® grafts yielded no differences with regard to primary patency rates (hazard ratio 1.04 (95% confidence interval [0.85;1.28]), no significant heterogeneity (p = 0.32, I2 = 14%)). Similarly, there were no significant differences with regard to secondary patency rates. Conclusion Systematic evaluation and meta-analysis of randomized controlled trials comparing Dacron® and PTFE as bypass materials for peripheral vascular surgery showed no evidence of an advantage of one synthetic material over the other. PMID:19099583

Change in food cravings, food preferences, and appetite during a low-carbohydrate and low-fat diet

PubMed Central

Martin, C. K.; Rosenbaum, D.; Han, H.; Geiselman, P.; Wyatt, H.; Hill, J.; Brill, C.; Bailer, B.; Miller, B. V.; Stein, R.; Klein, S.; Foster, Gard D.

2011-01-01

The study objective was to evaluate the effect of prescribing a low-carbohydrate diet (LCD) and a low-fat diet (LFD) on food cravings, food preferences, and appetite. Obese adults were randomly assigned to a LCD (n=134) or a LFD (n=136) for two years. Cravings for specific types of foods (sweets, high-fats, fast-food fats, carbohydrates/starches); preferences for high-sugar, high-carbohydrate, and low-carbohydrate/high-protein foods; and appetite were measured during the trial and evaluated during this secondary analysis of trial data. Differences between the LCD and LFD on change in outcome variables were examined with mixed linear models. Compared to the LFD, the LCD had significantly larger decreases in cravings for carbohydrates/starches and preferences for high-carbohydrate and high-sugar foods. The LCD group reported being less bothered by hunger compared to the LFD group. Compared to the LCD group, the LFD group had significantly larger decreases in cravings for high-fat foods and preference for low-carbohydrate/high-protein foods. Men had larger decreases in appetite ratings compared to women. Prescription of diets that promoted restriction of specific types of foods resulted in decreased cravings and preferences for the foods that were targeted for restriction. The results also indicate that the LCD group was less bothered by hunger compared to the LFD group and that men had larger reductions in appetite compared to women. PMID:21494226

Randomised trials comparing different healthcare settings: an exploratory review of the impact of pre-trial preferences on participation, and discussion of other methodological challenges.

PubMed

Corbett, Mark S; Watson, Judith; Eastwood, Alison

2016-10-19

We recently published a systematic review of different healthcare settings (such as outpatient, community or home) for administering intravenous chemotherapy, and concluded that performing conventionally designed randomised trials was difficult. The main problems were achieving adequate trial accrual rates and recruiting a study population which adequately represented the target population of interest. These issues stemmed from the fact that potential participants may have had pre-trial perceptions about the trial settings they may be allocated; such preferences will sometimes be strong enough for patients to decline an invitation to participate in a trial. A patient preference trial design (in which patients can choose, or be randomised to, an intervention) may have obviated these recruitment issues, although none of the trials used such a design. In order to gain a better understanding of the broader prevalence and extent of these preference issues (and any other methodological challenges), we undertook an exploratory review of settings trials in any area of healthcare treatment research. We searched The Cochrane Library and Google Scholar and used snowballing methods to identify trials comparing different healthcare settings. Trial accrual was affected by patient preferences for a setting in 15 of the 16 identified studies; birth setting trials were the most markedly affected, with between 68 % and 85 % of eligible women declining to participate specifically because of preference for a particular healthcare setting. Recruitment into substance abuse and chemotherapy setting studies was also notably affected by preferences. Only four trials used a preference design: the proportion of eligible patients choosing to participate via a preference group ranged from between 33 % and 67 %. In trials of healthcare settings, accrual may be seriously affected by patient preferences. The use of trial designs which incorporate a preference component should therefore strongly be considered. When designing such trials, investigators should consider settings to be complex interventions, which are likely to have linked components which may be difficult to control for. Careful thought is also needed regarding the choice of comparator settings and the most appropriate outcome measures to be used.

Qualitative assessment of Diabetes-STAR: a patient portal with disease management functions.

PubMed

Ross, Stephen E; Nowels, Carolyn T; Haverhals, Leah M; Bull, Sheana S; Lin, Chen-Tan; Main, Deborah S

2007-10-11

Diabetes-STAR is a disease management program integrated with an online patient portal. Of 331 patients enrolled in a randomized trial, we interviewed 37 users about benefits, barriers and recommendations for program improvements. User preferences included 1) addressing differences in types of users, 2) sending out alerts when new information is available, and 3) providing more oversight of user diary data.

The effect of images of Michelle Obama's face on trick-or-treaters' dietary choices: A randomized control trial.

PubMed

Aronow, Peter M; Karlan, Dean; Pinson, Lauren E

2018-01-01

To evaluate the microfoundations of a personality-inspired public health campaign's influence on minors. Multi-year randomized control trial. Economics professor's front porch in New Haven, CT. 1223 trick-or-treaters in New Haven over three years; on average, 8.5 years old and 53% male (among children whose gender was identifiable). Trick-or-treaters over the age of three that approached the house. Random assignment to the Michelle Obama side of the porch or the Comparison side of the porch. Selection of fruit over candy. Difference-in-means estimates. We estimate that viewing a photograph of Michelle Obama's face relative to control conditions caused children to be 19% more likely to choose fruit over candy. Michelle Obama's initiative to reduce childhood obesity has influenced children's dietary preferences. Whether this influence extends beyond Halloween trick-or-treating in New Haven, CT on the porch of an economics professor requires further research.

Initiation, adherence, and retention in a randomized controlled trial of directly administered antiretroviral therapy.

PubMed

Maru, Duncan Smith-Rohrberg; Bruce, R Douglas; Walton, Mary; Mezger, Jo Anne; Springer, Sandra A; Shield, David; Altice, Frederick L

2008-03-01

Directly administered antiretroviral therapy (DAART) can improve health outcomes among HIV-infected drug users. An understanding of the utilization of DAART-initiation, adherence, and retention-is critical to successful program design. Here, we use the Behavioral Model to assess the enabling, predisposing, and need factors impacting adherence in our randomized, controlled trial of DAART versus self-administered therapy (SAT) among 141 HIV-infected drug users. Of 88 participants randomized to DAART, 74 (84%) initiated treatment, and 51 (69%) of those who initiated were retained in the program throughout the entire six-month period. Mean adherence to directly observed visits was 73%, and the mean overall composite adherence score was 77%. These results were seen despite the finding that 75% of participants indicated that they would prefer to take their own medications. Major causes of DAART discontinuation included hospitalization, incarceration, and entry into drug-treatment programs. The presence of depression and the lack of willingness to travel greater than four blocks to receive DAART predicted time-to-discontinuation.

Initiation, Adherence, and Retention in a Randomized Controlled Trial of Directly Administered Antiretroviral Therapy

PubMed Central

Maru, Duncan Smith-Rohrberg; Bruce, R. Douglas; Walton, Mary; Mezger, Jo Anne; Springer, Sandra A.; Shield, David

2009-01-01

Directly administered antiretroviral therapy (DAART) can improve health outcomes among HIV-infected drug users. An understanding of the utilization of DAART—initiation, adherence, and retention—is critical to successful program design. Here, we use the Behavioral Model to assess the enabling, predisposing, and need factors impacting adherence in our randomized, controlled trial of DAART versus self-administered therapy (SAT) among 141 HIV-infected drug users. Of 88 participants randomized to DAART, 74 (84%) initiated treatment, and 51 (69%) of those who initiated were retained in the program throughout the entire six-month period. Mean adherence to directly observed visits was 73%, and the mean overall composite adherence score was 77%. These results were seen despite the finding that 75% of participants indicated that they would prefer to take their own medications. Major causes of DAART discontinuation included hospitalization, incarceration, and entry into drug-treatment programs. The presence of depression and the lack of willingness to travel greater than four blocks to receive DAART predicted time-to-discontinuation. PMID:18085432

Relationships Between Personal Beliefs and Treatment Acceptability, and Preferences for Behavioral Treatments

PubMed Central

Sidani, Souraya; Miranda, Joyal; Epstein, Dana R.; Bootzin, Richard R.; Cousins, Jennifer; Moritz, Patricia

2009-01-01

Background The literature on preferences for behavioral interventions is limited in terms of understanding treatment-related factors that underlie treatment choice. The objectives of this study were to examine the direct relationships between personal beliefs about clinical condition, perception of treatment acceptability, and preferences for behavioral interventions for insomnia. Methods The data set used in this study was obtained from 431 persons with insomnia who participated in a partially randomized clinical trial and expressed preferences for treatment options. The data were collected at baseline. Logistic regression was used to examine the relationships between personal beliefs and treatment acceptability, and preferences. The relationships between personal beliefs and perception of treatment acceptability were explored with correlational analysis. Results Perception of treatment acceptability was associated with preferences. Persons viewing the option as convenient tended to choose that option for managing insomnia. Personal beliefs were not related to preferences. However, beliefs about sleep promoting behaviors were correlated with perceived treatment effectiveness. Conclusions Perception of treatment acceptability underlies expressed preferences for behavioral interventions. Personal beliefs about insomnia are not directly associated with preferences. Importance is highlighted for providing information about treatment options and exploring perception of each option’s acceptability during the process of treatment selection. PMID:19604500

Preference of elderly patients' to oral or intravenous chemotherapy in heavily pre-treated recurrent ovarian cancer: final results of a prospective multicenter trial.

PubMed

Chekerov, Radoslav; Harter, Philipp; Fuxius, Stefan; Hanker, Lars Christian; Woelber, Linn; Müller, Lothar; Klare, Peter; Abenhardt, Wolfgang; Nedkova, Yoana; Yalcinkaya, Isil; Heinrich, Georg; Sommer, Harald; Mahner, Sven; Wimberger, Pauline; Koensgen-Mustea, Dominique; Richter, Rolf; Oskay-Oezcelik, Gülten; Sehouli, Jalid

2017-01-01

Palliative systemic treatment in elderly gynaecological cancer patients remains a major challenge. In recurrent ovarian cancer (ROC), treosulfan an active alkylating drug showed similar cytotoxicity whether as oral (p.o.) or intravenous (i.v.) application. The aim of this innovative trial was to evaluate the preference of elderly patients (≥65 years) for p.o. or i.v. chemotherapy focusing compliance, outcome, toxicities, and geriatric aspects as secondary endpoints. Patients with ROC had the free choice between treosulfan i.v. (7000 mg/m 2 d1, q29d) or p.o. (600 mg/m 2 daily d1-28, q57d). Only indecisive participants were randomized. Overall 123 patients with 2 nd to 5 th recurrence were registered and 119 received at least one cycle of chemotherapy. 85.7% preferred treosulfan i.v. and 14.3% oral, where only three patients were randomized. Main reasons for i.v. preference associated with individual expectations of lower rate of gastrointestinal disorders, higher activity and tolerability of treatment. Median of applied chemotherapies was three (range 1-12 cycles), with most common grade 3/4 toxicities thrombopenia (18.7%), leukopenia (15.7%), ascites (7.6%), bowel obstruction (6.7%), and abdominal pain (4.2%). Median time until progression/overall survival was 5.2/7.8 months (i.v.), and 5.6/10.4 months (p.o.), respectively, without significant differences in efficacy. Elderly patients with recurrent ovarian cancer asked and demonstrated active participation in the decision-making process of their oncological treatment and favoured predominantly the i.v. application. Treosulfan was generally well-tolerated despite comorbidities and heavy pre-treatment. Our study demonstrates that patients' preference did not influence prognosis negatively and remains important in gynaecologic oncology decision practice. 2004-000719-25; NCT 00170690.

Does Patient Preference Measurement in Decision Aids Improve Decisional Conflict? A Randomized Trial in Men with Prostate Cancer.

PubMed

Shirk, Joseph D; Crespi, Catherine M; Saucedo, Josemanuel D; Lambrechts, Sylvia; Dahan, Ely; Kaplan, Robert; Saigal, Christopher

2017-12-01

Shared decision making (SDM) has been advocated as an approach to medical decision making that can improve decisional quality. Decision aids are tools that facilitate SDM in the context of limited physician time; however, many decision aids do not incorporate preference measurement. We aim to understand whether adding preference measurement to a standard patient educational intervention improves decisional quality and is feasible in a busy clinical setting. Men with incident localized prostate cancer (n = 122) were recruited from the Greater Los Angeles Veterans Affairs (VA) Medical Center urology clinic, Olive View UCLA Medical Center, and Harbor UCLA Medical Center from January 2011 to May 2015 and randomized to education with a brochure about prostate cancer treatment or software-based preference assessment in addition to the brochure. Men undergoing preference assessment received a report detailing the relative strength of their preferences for treatment outcomes used in review with their doctor. Participants completed instruments measuring decisional conflict, knowledge, SDM, and patient satisfaction with care before and/or after their cancer consultation. Baseline knowledge scores were low (mean 62%). The baseline mean total score on the Decisional Conflict Scale was 2.3 (±0.9), signifying moderate decisional conflict. Men undergoing preference assessment had a significantly larger decrease in decisional conflict total score (p = 0.023) and the Perceived Effective Decision Making subscale (p = 0.003) post consult compared with those receiving education only. Improvements in satisfaction with care, SDM, and knowledge were similar between groups. Individual-level preference assessment is feasible in the clinic setting. Patients with prostate cancer who undergo preference assessment are more certain about their treatment decisions and report decreased levels of decisional conflict when making these decisions.

Buried Versus Exposed Kirschner Wires Following Fixation of Hand Fractures: l Clinician and Patient Surveys.

PubMed

2018-04-01

Fractures of the metacarpals and phalanges are common. Placement of Kirschner wires (K-wires) is the most common form of surgical fixation. After placement, a key decision is whether to bury the end of a K-wire or leave it protruding from the skin (exposed). A recent systematic review found no evidence to support either approach. The aim of study was to investigate current clinical practice, understand the key factors influencing clinician decision-making, and explore patient preferences to inform the design of a randomized clinical trial. The steering group developed surveys for hand surgeons, hand therapists, and patients. Following piloting, they were distributed across the United Kingdom hand surgery units using the Reconstructive Surgery Trials Network. A total of 423 hand surgeons, 187 hand therapists, and 187 patients completed the surveys. Plastic surgeons and junior surgical trainees preferred to leave K-wires not buried. Ease of removal correlated with a decision to leave wires exposed, whereas perceived risk of infection correlated with burying wires. Cost did not affect the decision. Hand therapists were primarily concerned about infection and patient-related outcomes. Patients were most concerned about wire-related problems and pain. This national survey provides a new understanding of the use of K-wires to manage hand fractures in the United Kingdom. A number of nonevidence-based factors seem to influence the decision to bury or leave K-wires exposed. The choice has important clinical and health economic implications that justify a randomized controlled trial.

Effect of joint mobilization techniques for primary total knee arthroplasty: Study protocol for a randomized controlled trial.

PubMed

Xu, Jiao; Zhang, Juan; Wang, Xue-Qiang; Wang, Xuan-Lin; Wu, Ya; Chen, Chan-Cheng; Zhang, Han-Yu; Zhang, Zhi-Wan; Fan, Kai-Yi; Zhu, Qiang; Deng, Zhi-Wei

2017-12-01

Total knee arthroplasty (TKA) has become the most preferred procedure by patients for the relief of pain caused by knee osteoarthritis. TKA patients aim a speedy recovery after the surgery. Joint mobilization techniques for rehabilitation have been widely used to relieve pain and improve joint mobility. However, relevant randomized controlled trials showing the curative effect of these techniques remain lacking to date. Accordingly, this study aims to investigate whether joint mobilization techniques are valid for primary TKA. We will manage a single-blind, prospective, randomized, controlled trial of 120 patients with unilateral TKA. Patients will be randomized into an intervention group, a physical modality therapy group, and a usual care group. The intervention group will undergo joint mobilization manipulation treatment once a day and regular training twice a day for a month. The physical modality therapy group will undergo physical therapy once a day and regular training twice a day for a month. The usual care group will perform regular training twice a day for a month. Primary outcome measures will be based on the visual analog scale, the knee joint Hospital for Special Surgery score, range of motion, surrounded degree, and adverse effect. Secondary indicators will include manual muscle testing, 36-Item Short Form Health Survey, Berg Balance Scale function evaluation, Pittsburgh Sleep Quality Index, proprioception, and muscle morphology. We will direct intention-to-treat analysis if a subject withdraws from the trial. The important features of this trial for joint mobilization techniques in primary TKA are randomization procedures, single-blind, large sample size, and standardized protocol. This study aims to investigate whether joint mobilization techniques are effective for early TKA patients. The result of this study may serve as a guide for TKA patients, medical personnel, and healthcare decision makers. It has been registered at http://www.chictr.org.cn/showproj.aspx?proj=15262 (Identifier:ChiCTR-IOR-16009192), Registered 11 September 2016. We also could provide the correct URL of the online registry in the WHO Trial Registration. http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR-IOR-16009192.

Auditory preferences of young children with and without hearing loss for meaningful auditory-visual compound stimuli.

PubMed

Zupan, Barbra; Sussman, Joan E

2009-01-01

Experiment 1 examined modality preferences in children and adults with normal hearing to combined auditory-visual stimuli. Experiment 2 compared modality preferences in children using cochlear implants participating in an auditory emphasized therapy approach to the children with normal hearing from Experiment 1. A second objective in both experiments was to evaluate the role of familiarity in these preferences. Participants were exposed to randomized blocks of photographs and sounds of ten familiar and ten unfamiliar animals in auditory-only, visual-only and auditory-visual trials. Results indicated an overall auditory preference in children, regardless of hearing status, and a visual preference in adults. Familiarity only affected modality preferences in adults who showed a strong visual preference to unfamiliar stimuli only. The similar degree of auditory responses in children with hearing loss to those from children with normal hearing is an original finding and lends support to an auditory emphasis for habilitation. Readers will be able to (1) Describe the pattern of modality preferences reported in young children without hearing loss; (2) Recognize that differences in communication mode may affect modality preferences in young children with hearing loss; and (3) Understand the role of familiarity in modality preferences in children with and without hearing loss.

Nurses' experiences, expectations, and preferences for mind-body practices to reduce stress.

PubMed

Kemper, Kathi; Bulla, Sally; Krueger, Deborah; Ott, Mary Jane; McCool, Jane A; Gardiner, Paula

2011-04-11

Most research on the impact of mind-body training does not ask about participants' baseline experience, expectations, or preferences for training. To better plan participant-centered mind-body intervention trials for nurses to reduce occupational stress, such descriptive information would be valuable. We conducted an anonymous email survey between April and June, 2010 of North American nurses interested in mind-body training to reduce stress. The e-survey included: demographic characteristics, health conditions and stress levels; experiences with mind-body practices; expected health benefits; training preferences; and willingness to participate in future randomized controlled trials. Of the 342 respondents, 96% were women and 92% were Caucasian. Most (73%) reported one or more health conditions, notably anxiety (49%); back pain (41%); GI problems such as irritable bowel syndrome (34%); or depression (33%). Their median occupational stress level was 4 (0 = none; 5 = extreme stress). Nearly all (99%) reported already using one or more mind-body practices to reduce stress: intercessory prayer (86%), breath-focused meditation (49%), healing or therapeutic touch (39%), yoga/tai chi/qi gong (34%), or mindfulness-based meditation (18%). The greatest expected benefits were for greater spiritual well-being (56%); serenity, calm, or inner peace (54%); better mood (51%); more compassion (50%); or better sleep (42%). Most (65%) wanted additional training; convenience (74% essential or very important), was more important than the program's reputation (49%) or scientific evidence about effectiveness (32%) in program selection. Most (65%) were willing to participate in a randomized trial of mind-body training; among these, most were willing to collect salivary cortisol (60%), or serum biomarkers (53%) to assess the impact of training. Most nurses interested in mind-body training already engage in such practices. They have greater expectations about spiritual and emotional than physical benefits, but are willing to participate in studies and to collect biomarker data. Recruitment may depend more on convenience than a program's scientific basis or reputation. Knowledge of participants' baseline experiences, expectations, and preferences helps inform future training and research on mind-body approaches to reduce stress.

Nurses' experiences, expectations, and preferences for mind-body practices to reduce stress

PubMed Central

2011-01-01

Background Most research on the impact of mind-body training does not ask about participants' baseline experience, expectations, or preferences for training. To better plan participant-centered mind-body intervention trials for nurses to reduce occupational stress, such descriptive information would be valuable. Methods We conducted an anonymous email survey between April and June, 2010 of North American nurses interested in mind-body training to reduce stress. The e-survey included: demographic characteristics, health conditions and stress levels; experiences with mind-body practices; expected health benefits; training preferences; and willingness to participate in future randomized controlled trials. Results Of the 342 respondents, 96% were women and 92% were Caucasian. Most (73%) reported one or more health conditions, notably anxiety (49%); back pain (41%); GI problems such as irritable bowel syndrome (34%); or depression (33%). Their median occupational stress level was 4 (0 = none; 5 = extreme stress). Nearly all (99%) reported already using one or more mind-body practices to reduce stress: intercessory prayer (86%), breath-focused meditation (49%), healing or therapeutic touch (39%), yoga/tai chi/qi gong (34%), or mindfulness-based meditation (18%). The greatest expected benefits were for greater spiritual well-being (56%); serenity, calm, or inner peace (54%); better mood (51%); more compassion (50%); or better sleep (42%). Most (65%) wanted additional training; convenience (74% essential or very important), was more important than the program's reputation (49%) or scientific evidence about effectiveness (32%) in program selection. Most (65%) were willing to participate in a randomized trial of mind-body training; among these, most were willing to collect salivary cortisol (60%), or serum biomarkers (53%) to assess the impact of training. Conclusions Most nurses interested in mind-body training already engage in such practices. They have greater expectations about spiritual and emotional than physical benefits, but are willing to participate in studies and to collect biomarker data. Recruitment may depend more on convenience than a program's scientific basis or reputation. Knowledge of participants' baseline experiences, expectations, and preferences helps inform future training and research on mind-body approaches to reduce stress. PMID:21481259

Logistic random effects regression models: a comparison of statistical packages for binary and ordinal outcomes

PubMed Central

2011-01-01

Background Logistic random effects models are a popular tool to analyze multilevel also called hierarchical data with a binary or ordinal outcome. Here, we aim to compare different statistical software implementations of these models. Methods We used individual patient data from 8509 patients in 231 centers with moderate and severe Traumatic Brain Injury (TBI) enrolled in eight Randomized Controlled Trials (RCTs) and three observational studies. We fitted logistic random effects regression models with the 5-point Glasgow Outcome Scale (GOS) as outcome, both dichotomized as well as ordinal, with center and/or trial as random effects, and as covariates age, motor score, pupil reactivity or trial. We then compared the implementations of frequentist and Bayesian methods to estimate the fixed and random effects. Frequentist approaches included R (lme4), Stata (GLLAMM), SAS (GLIMMIX and NLMIXED), MLwiN ([R]IGLS) and MIXOR, Bayesian approaches included WinBUGS, MLwiN (MCMC), R package MCMCglmm and SAS experimental procedure MCMC. Three data sets (the full data set and two sub-datasets) were analysed using basically two logistic random effects models with either one random effect for the center or two random effects for center and trial. For the ordinal outcome in the full data set also a proportional odds model with a random center effect was fitted. Results The packages gave similar parameter estimates for both the fixed and random effects and for the binary (and ordinal) models for the main study and when based on a relatively large number of level-1 (patient level) data compared to the number of level-2 (hospital level) data. However, when based on relatively sparse data set, i.e. when the numbers of level-1 and level-2 data units were about the same, the frequentist and Bayesian approaches showed somewhat different results. The software implementations differ considerably in flexibility, computation time, and usability. There are also differences in the availability of additional tools for model evaluation, such as diagnostic plots. The experimental SAS (version 9.2) procedure MCMC appeared to be inefficient. Conclusions On relatively large data sets, the different software implementations of logistic random effects regression models produced similar results. Thus, for a large data set there seems to be no explicit preference (of course if there is no preference from a philosophical point of view) for either a frequentist or Bayesian approach (if based on vague priors). The choice for a particular implementation may largely depend on the desired flexibility, and the usability of the package. For small data sets the random effects variances are difficult to estimate. In the frequentist approaches the MLE of this variance was often estimated zero with a standard error that is either zero or could not be determined, while for Bayesian methods the estimates could depend on the chosen "non-informative" prior of the variance parameter. The starting value for the variance parameter may be also critical for the convergence of the Markov chain. PMID:21605357

A clinical trial gone awry: the Chocolate Happiness Undergoing More Pleasantness (CHUMP) study.

PubMed

Chan, Kevin

2007-12-04

The randomized controlled trial is the "gold standard" for evaluating the benefits and harms of interventions. The Chocolate Happiness Undergoing More Pleasantness (CHUMP) study was designed to compare the effects of dark chocolate, milk chocolate and normal chocolate consumption on happiness. Although the intention-to-treat analysis showed that participants who received either dark or milk chocolate were happier than those who received no additional chocolate, the actual-consumption analysis showed that there were no differences between any of the groups. The reason for this result is that many participants switched groups mid-study because of their personal chocolate preferences. Although the CHUMP study was pleasurable, it demonstrated the difficulties associated with performing a truly blinded clinical trial.

A clinical trial gone awry: the Chocolate Happiness Undergoing More Pleasantness (CHUMP) study

PubMed Central

Chan, Kevin

2007-01-01

The randomized controlled trial is the “gold standard” for evaluating the benefits and harms of interventions. The Chocolate Happiness Undergoing More Pleasantness (CHUMP) study was designed to compare the effects of dark chocolate, milk chocolate and normal chocolate consumption on happiness. Although the intention-to-treat analysis showed that participants who received either dark or milk chocolate were happier than those who received no additional chocolate, the actual-consumption analysis showed that there were no differences between any of the groups. The reason for this result is that many participants switched groups mid-study because of their personal chocolate preferences. Although the CHUMP study was pleasurable, it demonstrated the difficulties associated with performing a truly blinded clinical trial. PMID:18056618

Determination of Tropical Forage Preferences Using Two Offering Methods in Rabbits

PubMed Central

Safwat, A. M.; Sarmiento-Franco, L.; Santos-Ricalde, R. H.; Nieves, D.

2014-01-01

Two methods of feed preference trials were compared to evaluate the acceptability of 5 fresh foliages: Leucaena leucocephala, Moringa oleifera, Portulaca oleracea, Guazuma ulmifolia, and Brosimum alicastrum that was included as control. The evaluation included chemical analyses and forage intake by rabbits. The first method was a cafeteria trial; 12 California growing rabbits aged 8 wk, allocated in individual cages, were offered the five forage plants at the same time inside the cage, while in the second trial 60 California growing rabbits aged 8 wk, allocated individually, were randomly distributed into 5 experimental groups (n = 12/group); for each group just one forage species was offered at a time. The testing period for each method lasted for 7 d, preceded by one week of adaptation. The results showed that B. alicastrum and L. lecocephala were the most preferred forages while on the contrary G. ulmifolia was the least preferred one by rabbits. The results also revealed that the CV% value for the 2nd method (16.32%), which the tested forages were presented separately to rabbits, was lower and methodologically more acceptable than such value for the 1st method (34.28%), which all forages were presented together at the same time. It can be concluded that a range of tropical forages were consumed in acceptable quantities by rabbits, suggesting that diets based on such forages with a concentrate supplement could be used successfully for rabbit production. However, growth performance studies are still needed before recommendations could be made on appropriate ration formulations for commercial use. PMID:25049983

Preoperative computer simulation for planning of vascular access surgery in hemodialysis patients.

PubMed

Zonnebeld, Niek; Huberts, Wouter; van Loon, Magda M; Delhaas, Tammo; Tordoir, Jan H M

2017-03-06

The arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis patients. Unfortunately, 20-40% of all constructed AVFs fail to mature (FTM), and are therefore not usable for hemodialysis. AVF maturation importantly depends on postoperative blood volume flow. Predicting patient-specific immediate postoperative flow could therefore support surgical planning. A computational model predicting blood volume flow is available, but the effect of blood flow predictions on the clinical endpoint of maturation (at least 500 mL/min blood volume flow, diameter of the venous cannulation segment ≥4 mm) remains undetermined. A multicenter randomized clinical trial will be conducted in which 372 patients will be randomized (1:1 allocation ratio) between conventional healthcare and computational model-aided decision making. All patients are extensively examined using duplex ultrasonography (DUS) during preoperative assessment (12 venous and 11 arterial diameter measurements; 3 arterial volume flow measurements). The computational model will predict patient-specific immediate postoperative blood volume flows based on this DUS examination. Using these predictions, the preferred AVF configuration is recommended for the individual patient (radiocephalic, brachiocephalic, or brachiobasilic). The primary endpoint is FTM rate at six weeks in both groups, secondary endpoints include AVF functionality and patency rates at 6 and 12 months postoperatively. ClinicalTrials.gov (NCT02453412), and ToetsingOnline.nl (NL51610.068.14).

Time efficiency, difficulty, and operator's preference comparing digital and conventional implant impressions: a randomized controlled trial.

PubMed

Joda, Tim; Lenherr, Patrik; Dedem, Philipp; Kovaltschuk, Irina; Bragger, Urs; Zitzmann, Nicola U

2017-10-01

The aim of this randomized controlled trial was to analyze implant impression techniques applying intraoral scanning (IOS) and the conventional method according to time efficiency, difficulty, and operator's preference. One hundred participants (n = 100) with diverse levels of dental experience were included and randomly assigned to Group A performing digital scanning (TRIOS Pod) first or Group B conducting conventional impression (open tray with elastomer) first, while the second method was performed consecutively. A customized maxillary model with a bone-level-type implant in the right canine position (FDI-position 13) was mounted on a phantom training unit realizing a standardized situation for all participants. Outcome parameter was time efficiency, and potential influence of clinical experience, operator's perception of level of difficulty, applicability of each method, and subjective preferences were analyzed with Wilcoxon -Mann-Whitney and Kruskal-Wallis tests. Mean total work time varied between 5.01 ± 1.56 min (students) and 4.53 ± 1.34 min (dentists) for IOS, and between 12.03 ± 2.00 min (students) and 10.09 ± 1.15 min (dentists) for conventional impressions with significant differences between the two methods. Neither assignment to Group A or B, nor gender nor number of impression-taking procedures did influence working time. Difficulty and applicability of IOS was perceived more favorable compared to conventional impressions, and effectiveness of IOS was rated better by the majority of students (88%) and dentists (64%). While 76% of the students preferred IOS, 48% of the dentists were favoring conventional impressions, and 26% each IOS and either technique. For single-implant sites, the quadrant-like intraoral scanning (IOS) was more time efficient than the conventional full-arch impression technique in a phantom head simulating standardized optimal conditions. A high level of acceptance for IOS was observed among students and dentists. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Preventing relapse in recurrent depression using mindfulness-based cognitive therapy, antidepressant medication or the combination: trial design and protocol of the MOMENT study

PubMed Central

2012-01-01

Background Depression is a common psychiatric disorder characterized by a high rate of relapse and recurrence. The most commonly used strategy to prevent relapse/recurrence is maintenance treatment with antidepressant medication (mADM). Recently, it has been shown that Mindfulness-Based Cognitive Therapy (MBCT) is at least as effective as mADM in reducing the relapse/recurrence risk. However, it is not yet known whether combination treatment of MBCT and mADM is more effective than either of these treatments alone. Given the fact that most patients have a preference for either mADM or for MBCT, the aim of the present study is to answer the following questions. First, what is the effectiveness of MBCT in addition to mADM? Second, how large is the risk of relapse/recurrence in patients withdrawing from mADM after participating in MBCT, compared to those who continue to use mADM after MBCT? Methods/design Two parallel-group, multi-center randomized controlled trials are conducted. Adult patients with a history of depression (3 or more episodes), currently either in full or partial remission and currently treated with mADM (6 months or longer) are recruited. In the first trial, we compare mADM on its own with mADM plus MBCT. In the second trial, we compare MBCT on its own, including tapering of mADM, with mADM plus MBCT. Follow-up assessments are administered at 3-month intervals for 15 months. Primary outcome is relapse/recurrence. Secondary outcomes are time to, duration and severity of relapse/recurrence, quality of life, personality, several process variables, and incremental cost-effectiveness ratio. Discussion Taking into account patient preferences, this study will provide information about a) the clinical and cost-effectiveness of mADM only compared with mADM plus MBCT, in patients with a preference for mADM, and b) the clinical and cost-effectiveness of withdrawing from mADM after MBCT, compared with mADM plus MBCT, in patients with a preference for MBCT. Trial registration ClinicalTrials.gov: NCT00928980 PMID:22925198

A Randomized Trial of Brief Versus Extended Seizure Prophylaxis After Aneurysmal Subarachnoid Hemorrhage.

PubMed

Human, Theresa; Diringer, Michael N; Allen, Michelle; Zipfel, Gregory J; Chicoine, Michael; Dacey, Ralph; Dhar, Rajat

2018-04-01

Seizures occur in 10-20% of patients with subarachnoid hemorrhage (SAH), predominantly in the acute phase. However, anticonvulsant prophylaxis remains controversial, with studies suggesting a brief course may be adequate and longer exposure may be associated with worse outcomes. Nonetheless, in the absence of controlled trials to inform practice, patients continue to receive variable chemoprophylaxis. The objective of this study was to compare brief versus extended seizure prophylaxis after aneurysmal SAH. We performed a prospective, single-center, randomized, open-label trial of a brief (3-day) course of levetiracetam (LEV) versus extended treatment (until hospital discharge). The primary outcome was in-hospital seizure. Secondary outcomes included drug discontinuation and functional outcome. Eighty-four SAH patients had been randomized when the trial was terminated due to slow enrollment. In-hospital seizures occurred in three (9%) of 35 in the brief LEV group versus one (2%) of 49 in the extended group (p = 0.2). Ten (20%) of the extended group discontinued LEV prematurely, primarily due to sedation. Four of five seizures (including one pre-randomization) occurred in patients with early brain injury (EBI) on computed tomography (CT) scans (adjusted OR 12.5, 95% CI 1.2-122, p = 0.03). Good functional outcome (mRS 0-2) was more likely in the brief LEV group (83 vs. 61%, p = 0.04). This study was underpowered to demonstrate superiority of extended LEV for seizure prophylaxis, although a trend to benefit was seen. Seizures primarily occurred in those with radiographic EBI, suggesting targeted prophylaxis may be preferable. Larger trials are required to evaluate optimal chemoprophylaxis in SAH, especially in light of worse outcomes in those receiving extended treatment.

Patients’ Perspectives of Enrollment in Research Without Consent- The Patients’ Experiences in Emergency Research- ProTECT Study (PEER-ProTECT)

PubMed Central

Dickert, Neal W; Scicluna, Victoria M; Baren, Jill M; Biros, Michelle H; Fleischman, Ross J; Govindarajan, Prasanthi R; Jones, Elizabeth B; Pancioli, Arthur M; Wright, David W; Pentz, Rebecca D

2016-01-01

Objective Research in acute illness often requires an exception from informed consent (EFIC). Few studies have assessed the views of patients enrolled in EFIC trials. This study was designed to assess the views of patients and their surrogates of EFIC enrollment in a randomized, placebo-controlled trial of an investigational agent for traumatic brain injury. Design Interactive interview study. Setting Nested within the Progesterone for the Treatment of Traumatic Brain Injury (ProTECT III) trial, a Phase III randomized controlled trial in acute traumatic brain injury (TBI). Participants Patients and surrogates (for patients incapable of being interviewed) enrolled in ProTECT III under EFIC at 12 sites. Measurements Interviews focused on respondents’ acceptance of EFIC enrollment in ProTECT, use of placebo and randomization, understanding of major study elements, and views regarding regulatory protections. Descriptive statistical analysis was performed; textual data were analyzed thematically. Main Results 85 individuals were interviewed. 84% had positive attitudes toward ProTECT III inclusion. 78% found their inclusion under EFIC acceptable, and 72% found use of EFIC in ProTECT III acceptable in general. Only 2 respondents clearly disagreed with both personal and general EFIC enrollment. The most common concerns (26%) related to absence of consent. 80% and 92% were accepting of placebo use and randomization, respectively. Though there were few black respondents (n=11), they were less accepting of personal EFIC enrollment than white respondents (55% vs 83%, p= 0.0494). Conclusions Acceptance of EFIC in this placebo-controlled trial of an investigational agent was high and exceeded acceptance among community consultation participants. EFIC enrollment appears generally consistent with patients’ preferences. PMID:25574795

A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial.

PubMed

Rao, Sunil V; Hess, Connie N; Barham, Britt; Aberle, Laura H; Anstrom, Kevin J; Patel, Tejan B; Jorgensen, Jesse P; Mazzaferri, Ernest L; Jolly, Sanjit S; Jacobs, Alice; Newby, L Kristin; Gibson, C Michael; Kong, David F; Mehran, Roxana; Waksman, Ron; Gilchrist, Ian C; McCourt, Brian J; Messenger, John C; Peterson, Eric D; Harrington, Robert A; Krucoff, Mitchell W

2014-08-01

This study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial. Women are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear. Women undergoing cardiac catheterization or PCI were randomized to radial or femoral arterial access. Data from the CathPCI Registry and trial-specific data were merged into a final study database. The primary efficacy endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding or vascular complications requiring intervention. The primary feasibility endpoint was access site crossover. The primary analysis cohort was the subgroup undergoing PCI; sensitivity analyses were conducted in the total randomized population. The trial was stopped early for a lower than expected event rate. A total of 1,787 women (691 undergoing PCI) were randomized at 60 sites. There was no significant difference in the primary efficacy endpoint between radial or femoral access among women undergoing PCI (radial 1.2% vs. 2.9% femoral, odds ratio [OR]: 0.39; 95% confidence interval [CI]: 0.12 to 1.27); among women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding and vascular complications (0.6% vs. 1.7%; OR: 0.32; 95% CI: 0.12 to 0.90). Access site crossover was significantly higher among women assigned to radial access (PCI cohort: 6.1% vs. 1.7%; OR: 3.65; 95% CI: 1.45 to 9.17); total randomized cohort: (6.7% vs. 1.9%; OR: 3.70; 95% CI: 2.14 to 6.40). More women preferred radial access. In this pragmatic trial, which was terminated early, the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI. Access site crossover occurred more often in women assigned to radial access. (SAFE-PCI for Women; NCT01406236). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Hospital Inpatient versus HOme-based rehabilitation after knee arthroplasty (The HIHO study): study protocol for a randomized controlled trial.

PubMed

Buhagiar, Mark A; Naylor, Justine M; Harris, Ian A; Xuan, Wei; Kohler, Friedbert; Wright, Rachael J; Fortunato, Renee

2013-12-17

Formal rehabilitation programs are often assumed to be required after total knee arthroplasty to optimize patient recovery. Inpatient rehabilitation is a costly rehabilitation option after total knee arthroplasty and, in Australia, is utilized most frequently for privately insured patients. With the exception of comparisons with domiciliary services, no randomized trial has compared inpatient rehabilitation to any outpatient based program. The Hospital Inpatient versus HOme (HIHO) study primarily aims to determine whether 10 days of post-acute inpatient rehabilitation followed by a hybrid home program provides superior recovery of functional mobility on the 6-minute walk test (6MWT) compared to a hybrid home program alone following total knee arthroplasty. Secondarily, the trial aims to determine whether inpatient rehabilitation yields superior recovery in patient-reported function. This is a two-arm parallel randomized controlled trial (RCT), with a third, non-randomized, observational group. One hundred and forty eligible, consenting participants who have undergone a primary total knee arthroplasty at a high-volume joint replacement center will be randomly allocated when cleared for discharge from acute care to either 10 days of inpatient rehabilitation followed by usual care (a 6-week hybrid home program) or to usual care. Seventy participants in each group (140 in total) will provide 80% power at a significance level of 5% to detect an increase in walking capacity from 400 m to 460 m between the Home and Inpatient groups, respectively, in the 6MWT at 6 months post-surgery, assuming a SD of 120 m and a drop-out rate of <10%.The outcome assessor will assess participants at 10, 26 and 52 weeks post-operatively, and will remain blind to group allocation for the duration of the study, as will the statistician. Participant preference for rehabilitation mode stated prior to randomization will be accounted for in the analysis together with any baseline differences in potentially confounding characteristics as required. The HIHO Trial will be the first RCT to investigate the efficacy of inpatient rehabilitation compared to any outpatient alternative following total knee arthroplasty. U.S. National Institutes of Health Clinical Trials Registry (http://clinicaltrials.gov) ref: NCT01583153.

Treatment benefit and the risk of suicidality in multicenter, randomized, controlled trials of sertraline in children and adolescents.

PubMed

March, John S; Klee, Brian J; Kremer, Charlotte M E

2006-01-01

The aim of this study was to examine the balance between the benefits of treatment and the risk of suicidality in children and adolescents in multicenter, randomized, controlled trials of sertraline versus placebo. The published literature was searched for multicenter, randomized, placebo-controlled trials of sertraline for pediatric mental disorders. Four trials were identified: Two (pooled) in pediatric major depressive disorder (MDD; Wagner 2003) and two in obsessive-compulsive disorder (OCD; March et al. 1998; POTS Team 2004). Using intent-to-treat (ITT) analysis populations, the authors calculated the number needed to treat (NNT) for response and remission and the number needed to harm (NNH) for suicidality, and their ratio, for each clinical trial. NNTs ranged from 2 to 10, indicating clinically meaningful benefits. Benefit was greater for OCD than for MDD, and for adolescents as compared with children in MDD. No age effect was apparent for OCD. Suicidality was reported in 8 patients (5 assigned to sertraline and 3 assigned to placebo). All but 1 (a placebo-treated patient in the Pfizer OCD trial) were enrolled in the sertraline MDD trial. The NNH for suicidality in MDD was 64. Treatment emergent suicidality was more common in children (NNH 28.7) than in adolescents (NNH 706.3). Because no patient developed suicidality in sertraline-treated OCD patients, the NNH for sertraline in OCD approaches infinity. With the stipulation that doctor and patient preferences necessarily play a critical role in the choice of treatment, NNT to NNH ratios indicate a positive benefit-to-risk ratio for sertraline in adolescents with MDD and in patients of all ages with OCD.

Learning to dislike safe water products: results from a randomized controlled trial of the effects of direct and peer experience on willingness to pay.

PubMed

Luoto, Jill; Mahmud, Minhaj; Albert, Jeff; Luby, Stephen; Najnin, Nusrat; Unicomb, Leanne; Levine, David I

2012-06-05

Low-cost point-of-use (POU) safe water products have the potential to reduce waterborne illness, but adoption by the global poor remains low. We performed an eight-month randomized trial of four low-cost household water treatment products in Dhaka, Bangladesh. Intervention households (n = 600) received repeated educational messages about the importance of drinking safe water along with consecutive two-month free trials with each of four POU products in random order. Households randomly assigned to the control group (n = 200) did not receive free products or repeated educational messages. Households' willingness to pay for these products was quite low on average (as measured by bids in an incentive-compatible real-money auction), although a modest share was willing to pay the actual or expected retail price for low-cost chlorine-based products. Furthermore, contrary to our hypotheses that both one's own personal experience and the influence of one's peers would increase consumers' willingness to pay, direct experience significantly decreased mean bids by 18-55% for three of the four products and had no discernible effect on the fourth. Neighbor experience also did not increase bids. Widespread dissemination of safe water products is unlikely until we better understand the preferences and aspirations of these at-risk populations.

Patients' preferences for selection of endpoints in cardiovascular clinical trials.

PubMed

Chow, Robert D; Wankhedkar, Kashmira P; Mete, Mihriye

2014-01-01

To reduce the duration and overall costs of cardiovascular trials, use of the combined endpoints in trial design has become commonplace. Though this methodology may serve the needs of investigators and trial sponsors, the preferences of patients or potential trial subjects in the trial design process has not been studied. To determine the preferences of patients in the design of cardiovascular trials. Participants were surveyed in a pilot study regarding preferences among various single endpoints commonly used in cardiovascular trials, preference for single vs. composite endpoints, and the likelihood of compliance with a heart medication if patients similar to them participated in the trial design process. One hundred adult English-speaking patients, 38% male, from a primary care ambulatory practice located in an urban setting. Among single endpoints, participants rated heart attack as significantly more important than death from other causes (4.53 vs. 3.69, p=0.004) on a scale of 1-6. Death from heart disease was rated as significantly more important than chest pain (4.73 vs. 2.47, p<0.001), angioplasty/PCI/CABG (4.73 vs. 2.43, p<0.001), and stroke (4.73 vs. 2.43, p<0.001). Participants also expressed a slight preference for combined endpoints over single endpoint (43% vs. 57%), incorporation of the opinions of the study patient population into the design of trials (48% vs. 41% for researchers), and a greater likelihood of medication compliance if patient preferences were considered during trial design (67% indicated a significant to major effect). Patients are able to make judgments and express preferences regarding trial design. They prefer that the opinions of the study population rather than the general population be incorporated into the design of the study. This novel approach to study design would not only incorporate patient preferences into medical decision making, but it also has the potential to improve compliance with cardiovascular medications.

Case-based or non-case-based questions for teaching postgraduate physicians: a randomized crossover trial.

PubMed

Cook, David A; Thompson, Warren G; Thomas, Kris G

2009-10-01

The comparative efficacy of case-based (CB) and non-CB self-assessment questions in Web-based instruction is unknown. The authors sought to compare CB and non-CB questions. The authors conducted a randomized crossover trial in the continuity clinics of two academic residency programs. Four Web-based modules on ambulatory medicine were developed in both CB (periodic questions based on patient scenarios) and non-CB (questions matched for content but lacking patient scenarios) formats. Participants completed two modules in each format (sequence randomly assigned). Participants also completed a pretest of applied knowledge for two modules (randomly assigned). For the 130 participating internal medicine and family medicine residents, knowledge scores improved significantly (P < .0001) from pretest (mean: 53.5; SE: 1.1) to posttest (75.1; SE: 0.7). Posttest knowledge scores were similar in CB (75.0; SE: 0.1) and non-CB formats (74.7; SE: 1.1); the 95% CI was -1.6, 2.2 (P = .76). A nearly significant (P = .062) interaction between format and the presence or absence of pretest suggested a differential effect of question format, depending on pretest. Overall, those taking pretests had higher posttest knowledge scores (76.7; SE: 1.1) than did those not taking pretests (73.0; SE: 1.1; 95% CI: 1.7, 5.6; P = .0003). Learners preferred the CB format. Time required was similar (CB: 42.5; SE: 1.8 minutes, non-CB: 40.9; SE: 1.8 minutes; P = .22). Our findings suggest that, among postgraduate physicians, CB and non-CB questions have similar effects on knowledge scores, but learners prefer CB questions. Pretests influence posttest scores.

Multimedia in the informed consent process for endoscopic sinus surgery: A randomized control trial.

PubMed

Siu, Jennifer M; Rotenberg, Brian W; Franklin, Jason H; Sowerby, Leigh J

2016-06-01

To determine patient recall of specific risks associated with endoscopic sinus surgery and whether an adjunct multimedia education module is an effective patient tool in enhancing the standard informed consent process. Prospective, randomized, controlled trial. Fifty consecutive adult patients scheduled for endoscopic sinus surgery at a rhinology clinic of a tertiary care hospital were recruited for this study. Informed consent was studied by comparing the number of risks recalled when patients had a verbal discussion in conjunction with a 6-minute interactive module or the verbal discussion alone. Early recall was measured immediately following the informed consent process, and delayed recall was measured 3 to 4 weeks after patient preference details were also collected. Early risk recall in the multimedia group was significantly higher than the control group (P = .0036); however, there was no difference between the groups in delayed risk recall. Seventy-six percent of participants expressed interest in viewing the multimedia module if available online between the preoperative and procedural day. Sixty-eight percent of patients preferred having the multimedia module as an adjunct to the informed consent process as opposed to the multimedia consent process alone. There is an early improvement in overall risk recall in patients who complete an interactive multimedia module, with a clear patient preference for this method. Here we emphasize the well-known challenges of patient education and demonstrate the effectiveness of integrating technology into clinical practice in order to enhance the informed consent process. 1b Laryngoscope, 126:1273-1278, 2016. © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

Papillary fibroelastomas: innocent bystanders or ignored culprits?

PubMed

Saloura, Vassiliki; Grivas, Petros D; Sarwar, A Bilal; Gorodin, Paulina; Ledley, Gary S

2009-05-01

Cardiac papillary fibroelastomas (PFEs) are the most common tumors of the cardiac valves and the third most common cardiac tumor. They are usually detected accidentally on echocardiography, but have the potential to manifest with catastrophic embolic phenomena, resulting in stroke and myocardial infarction. Echocardiography is currently the preferred diagnostic modality, while magnetic resonance imaging and computed tomography are helpful in the differential diagnosis of cardiac tumors. The management of PFEs is empiric, as no large randomized trials have been conducted to support specific treatment guidelines. The treatment of choice for PFEs with high-risk features for peripheral embolization is surgical resection. Anticoagulation is recommended in patients who are poor surgical candidates or who refuse surgery, although its duration and intensity are debatable. This review summarizes current knowledge on the epidemiology, pathology, pathophysiology, clinical manifestations, diagnosis, and treatment of PFEs. It also highlights the need for large randomized clinical trials that would delineate more specific guidelines for managing PFEs with anticoagulation.

Pain in donor site after BTB-ACL reconstruction with PRGF: a randomized trial.

PubMed

Seijas, Roberto; Cuscó, Xavier; Sallent, Andrea; Serra, Iván; Ares, Oscar; Cugat, Ramón

2016-06-01

Anterior cruciate ligament (ACL) tears are highly incident injuries in young athletes within our work area. The use of the patellar graft, despite being the treatment of choice, presents post-operative problems such as anterior knee pain, which limits its use and leads to preference being taken for alternative grafts. Our aim was to evaluate if the application of PRGF reduces anterior knee pain in donor site in BTB-ACL reconstruction. 43 patients were included in the double-blinded and randomized clinical trial comparing two patient groups who underwent ACL reconstruction using patellar tendon graft, comparing anterior knee pain with and without the application of PRGF at the donor site after harvesting the graft. The PRGF group showed decreased donor site pain in comparison to the control group, with significant differences in the first two months of follow-up. The application of PRGF decreased donor site pain compared to the control group.

Laboratory- and community-based health outcomes in people with transtibial amputation using crossover and energy-storing prosthetic feet: A randomized crossover trial

PubMed Central

Morgan, Sara J.; McDonald, Cody L.; Halsne, Elizabeth G.; Cheever, Sarah M.; Salem, Rana; Kramer, Patricia A.

2018-01-01

Contemporary prosthetic feet are generally optimized for either daily or high-level activities. Prosthesis users, therefore, often require multiple prostheses to participate in activities that span a range of mobility. Crossover feet (XF) are designed to increase the range of activities that can be performed with a single prosthesis. However, little evidence exists to guide clinical prescription of XF relative to traditional energy storing feet (ESF). The objective of this study was to assess the effects of XF and ESF on health outcomes in people with transtibial amputation. A randomized crossover study was conducted to assess changes in laboratory-based (endurance, perceived exertion, walking performance) and community-based (step activity and self-reported mobility, fatigue, balance confidence, activity restrictions, and satisfaction) outcomes. Twenty-seven participants were fit with XF and ESF prostheses with standardized sockets, interfaces, and suspensions. Participants were not blinded to the intervention, and wore each prosthesis for one month while their steps were counted with an activity monitor. After each accommodation period, participants returned for data collection. Endurance and perceived exertion were measured with the Six-Minute Walk Test and Borg-CR100, respectively. Walking performance was measured using an electronic walkway. Self-reported mobility, fatigue, balance confidence, activity restrictions, and satisfaction were measured with survey instruments. Participants also reported foot preferences upon conclusion of the study. Differences between feet were assessed with a crossover analysis. While using XF, users experienced improvements in most community-based outcomes, including mobility (p = .001), fatigue (p = .001), balance confidence (p = .005), activity restrictions (p = .002), and functional satisfaction (p < .001). Participants also exhibited longer sound side steps in XF compared to ESF (p < .001). Most participants (89%) reported an overall preference for XF; others (11%) reported no preference. Results indicate that XF may be a promising alternative to ESF for people with transtibial amputation who engage in a range of mobility activities. Trial registration: ClinicalTrials.gov NCT02440711 PMID:29414988

Advanced Cancer and End-of-Life Preferences: Curative Intent Surgery Versus Noncurative Intent Treatment.

PubMed

Schubart, Jane R; Green, Michael J; Van Scoy, Lauren J; Lehman, Erik; Farace, Elana; Gusani, Niraj J; Levi, Benjamin H

2015-12-01

People with cancer face complex medical decisions, including whether to receive life-sustaining treatments at the end of life. It is not unusual for clinicians to make assumptions about patients' wishes based on whether they had previously chosen to pursue curative treatment. We hypothesized that cancer patients who initially underwent curative intent surgery (CIS) would prefer more aggressive end-of-life treatments compared to patients whose treatment was noncurative intent (non-CIT). This study was a retrospective review of data from a large, randomized controlled trial examining the use of an online decision aid for advance care planning, "Making Your Wishes Known" (MYWK), with patients who had advanced cancer. We reviewed patients' medical records to determine which patients underwent CIS versus non-CIT. In the parent trial, conducted at an academic medical center (2007-2012), 200 patients were enrolled with stage IV malignancy or other poor prognosis cancer. Patients' preferences for aggressive treatment were measured in two ways: using patient-selected General Wishes statements generated by the decision aid and patient-selected wishes for specific treatments under various hypothetical clinical scenarios (Specific Wishes). We evaluated 79 patients. Of these, 48 had undergone initial CIS and 31 had non-CIT. Cancer patients who initially underwent CIS did not prefer more aggressive end-of-life treatments compared to patients whose treatment was non-CIT. Clinicians should avoid assumptions about patients' preferences for life-sustaining treatment based on their prior choices for aggressive treatment.

A Randomized Controlled Trial Comparing the McKenzie Method to Motor Control Exercises in People With Chronic Low Back Pain and a Directional Preference.

PubMed

Halliday, Mark H; Pappas, Evangelos; Hancock, Mark J; Clare, Helen A; Pinto, Rafael Z; Robertson, Gavin; Ferreira, Paulo H

2016-07-01

Study Design Randomized clinical trial. Background Motor control exercises are believed to improve coordination of the trunk muscles. It is unclear whether increases in trunk muscle thickness can be facilitated by approaches such as the McKenzie method. Furthermore, it is unclear which approach may have superior clinical outcomes. Objectives The primary aim was to compare the effects of the McKenzie method and motor control exercises on trunk muscle recruitment in people with chronic low back pain classified with a directional preference. The secondary aim was to conduct a between-group comparison of outcomes for pain, function, and global perceived effect. Methods Seventy people with chronic low back pain who demonstrated a directional preference using the McKenzie assessment were randomized to receive 12 treatments over 8 weeks with the McKenzie method or with motor control approaches. All outcomes were collected at baseline and at 8-week follow-up by blinded assessors. Results No significant between-group difference was found for trunk muscle thickness of the transversus abdominis (-5.8%; 95% confidence interval [CI]: -15.2%, 3.7%), obliquus internus (-0.7%; 95% CI: -6.6%, 5.2%), and obliquus externus (1.2%; 95% CI: -4.3%, 6.8%). Perceived recovery was slightly superior in the McKenzie group (-0.8; 95% CI: -1.5, -0.1) on a -5 to +5 scale. No significant between-group differences were found for pain or function (P = .99 and P = .26, respectively). Conclusion We found no significant effect of treatment group for trunk muscle thickness. Participants reported a slightly greater sense of perceived recovery with the McKenzie method than with the motor control approach. Level of Evidence Therapy, level 1b-. Registered September 7, 2011 at www.anzctr.org.au (ACTRN12611000971932). J Orthop Sports Phys Ther 2016;46(7):514-522. Epub 12 May 2016. doi:10.2519/jospt.2016.6379.

Adherence and acceptability in MTN 001: A randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women

PubMed Central

Minnis, Alexandra M.; Gandham, Sharavi; Richardson, Barbra A.; Guddera, Vijayanand; Chen, Beatrice A.; Salata, Robert; Nakabiito, Clemensia; Hoesley, Craig; Justman, Jessica; Soto-Torres, Lydia; Patterson, Karen; Gomez, Kailazarid; Hendrix, Craig

2012-01-01

We compared adherence to and acceptability of daily topical and oral formulations of tenofovir (TFV) used as pre-exposure prophylaxis (PrEP) for HIV prevention among women in South Africa, Uganda and the United States. 144 sexually active, HIV-uninfected women participated in a cross-over study of three regimens: oral tablet, vaginal gel, or both. We tested for differences in adherence and evaluated product acceptability. Self-reported adherence for all regimens was high (94%), but serum TFV concentrations indicated only 64% of participants used tablets consistently. Most women in the U.S. (72%) favored tablets over gel; while preferences varied at the African sites (42% preferred gel and 40% tablets). Findings indicate a role for oral and vaginal PrEP formulations and highlight the importance of integrating pharmacokinetics-based adherence assessment in future trials. Biomedical HIV prevention interventions should consider geographic and cultural experience with product formulations, partner involvement, and sexual health benefits that ultimately influence use. PMID:23065145

Management of atrial fibrillation in the post-cardiac surgery setting.

PubMed

Daoud, Emile G

2004-02-01

New onset postcardiac surgery AF is a prevalent problem associated with increased morbidity, hospital expense, and length of stay. Those agents that inhibit beta-adrenergic receptors (class II beta-blockers, sotalol, and amiodarone) have been demonstrated to be successful prophylaxis against postoperative AF. Furthermore, those therapies that do not inhibit beta-receptors are not effective prophylactic agents. Until comparative trials demonstrate a significant reduction in postoperative AF without additional adverse effects for sotalol or amiodarone compared with beta-blockers, class II beta-blockers are the preferred prophylactic therapy. If patients are deemed unable to take beta-blockers, amiodarone is likely the best alternative. Although prophylaxis against postoperative AF seems prudent, the impact of prophylactic therapy on length of stay and hospital costs has not been a primary objective of any randomized trial. Furthermore, no studies have compared prophylactic therapy for every patient versus therapy only for those patients who experience AF after heart surgery. In the absence of data from randomized clinical trials, postoperative AF should be managed in a similar fashion to clinical AF with attention to rate control, anticoagulation, and restoration of sinus rhythm.

LA Sprouts: A 12-Week Gardening, Nutrition, and Cooking Randomized Control Trial Improves Determinants of Dietary Behaviors.

PubMed

Davis, Jaimie N; Martinez, Lauren C; Spruijt-Metz, Donna; Gatto, Nicole M

2016-01-01

To evaluate the effect of an exploratory 12-week nutrition, cooking, and gardening trial (LA Sprouts) on preference for fruit and vegetables (FV); willingness to try FV; identification of FV; self-efficacy to garden, eat, and cook FV; motivation to garden, eat, and cook FV; attitudes toward FV; nutrition and gardening knowledge; and home gardening habits. Randomized controlled trial. Four elementary schools. Three hundred four predominately Hispanic/Latino third- through fifth-grade students were randomized to either the LA Sprouts group (n = 167 students) or control group (n = 137 students). Twelve-week after-school nutrition, cooking, and gardening intervention. Determinants of dietary behavior as measured by questionnaire at baseline and postintervention. Analyses of covariance. After the 12-week program, compared with controls, LA Sprouts participants improved scores for identification of vegetables (+11% vs +5%; P = .001) and nutrition and gardening knowledge (+14.5% vs -5.0%; P = .003), and were more likely to garden at home (+7.5% vs -4.4%; P = .003). The LA Sprouts program positively affected a number of determinants of dietary behaviors that suggest possible mechanisms by which gardening and nutrition education act to improve dietary intake and health outcomes. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

A Randomized Clinical Trial of Methadone Maintenance for Prisoners: Prediction of Treatment Entry and Completion in Prison

PubMed Central

GORDON, MICHAEL S.; KINLOCK, TIMOTHY W.; COUVILLION, KATHRYN A.; SCHWARTZ, ROBERT P.; O’GRADY, KEVIN

2014-01-01

The present report is an intent-to-treat analysis involving secondary data drawn from the first randomized clinical trial of prison-initiated methadone in the United States. This study examined predictors of treatment entry and completion in prison. A sample of 211 adult male prerelease inmates with preincarceration heroin dependence were randomly assigned to one of three treatment conditions: counseling only (counseling in prison; n= 70); counseling plus transfer (counseling in prison with transfer to methadone maintenance treatment upon release; n= 70); and counseling plus methadone (methadone maintenance in prison, continued in a community-based methadone maintenance program upon release; n= 71). Entered prison treatment (p <. 01), and completed prison treatment (p< .001) were significantly predicted by the set of 10 explanatory variables and favored the treatment conditions receiving methadone. The present results indicate that individuals who are older in age and have longer prison sentences may have better outcomes than younger individuals with shorter sentences, meaning they are more likely to enter and complete prison-based treatment. Furthermore, implications for the treatment of prisoners with prior heroin dependence and for conducting clinical trials may indicate the importance of examining individual characteristics and the possibility of the examination of patient preference. PMID:25392605

A Randomized Clinical Trial of Methadone Maintenance for Prisoners: Prediction of Treatment Entry and Completion in Prison.

PubMed

Gordon, Michael S; Kinlock, Timothy W; Couvillion, Kathryn A; Schwartz, Robert P; O'Grady, Kevin

2012-05-01

The present report is an intent-to-treat analysis involving secondary data drawn from the first randomized clinical trial of prison-initiated methadone in the United States. This study examined predictors of treatment entry and completion in prison. A sample of 211 adult male prerelease inmates with preincarceration heroin dependence were randomly assigned to one of three treatment conditions: counseling only (counseling in prison; n= 70); counseling plus transfer (counseling in prison with transfer to methadone maintenance treatment upon release; n= 70); and counseling plus methadone (methadone maintenance in prison, continued in a community-based methadone maintenance program upon release; n= 71). Entered prison treatment (p <. 01), and completed prison treatment (p< .001) were significantly predicted by the set of 10 explanatory variables and favored the treatment conditions receiving methadone. The present results indicate that individuals who are older in age and have longer prison sentences may have better outcomes than younger individuals with shorter sentences, meaning they are more likely to enter and complete prison-based treatment. Furthermore, implications for the treatment of prisoners with prior heroin dependence and for conducting clinical trials may indicate the importance of examining individual characteristics and the possibility of the examination of patient preference.

Hospital Inpatient versus HOme-based rehabilitation after knee arthroplasty (The HIHO study): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Formal rehabilitation programs are often assumed to be required after total knee arthroplasty to optimize patient recovery. Inpatient rehabilitation is a costly rehabilitation option after total knee arthroplasty and, in Australia, is utilized most frequently for privately insured patients. With the exception of comparisons with domiciliary services, no randomized trial has compared inpatient rehabilitation to any outpatient based program. The Hospital Inpatient versus HOme (HIHO) study primarily aims to determine whether 10 days of post-acute inpatient rehabilitation followed by a hybrid home program provides superior recovery of functional mobility on the 6-minute walk test (6MWT) compared to a hybrid home program alone following total knee arthroplasty. Secondarily, the trial aims to determine whether inpatient rehabilitation yields superior recovery in patient-reported function. Methods/Design This is a two-arm parallel randomized controlled trial (RCT), with a third, non-randomized, observational group. One hundred and forty eligible, consenting participants who have undergone a primary total knee arthroplasty at a high-volume joint replacement center will be randomly allocated when cleared for discharge from acute care to either 10 days of inpatient rehabilitation followed by usual care (a 6-week hybrid home program) or to usual care. Seventy participants in each group (140 in total) will provide 80% power at a significance level of 5% to detect an increase in walking capacity from 400 m to 460 m between the Home and Inpatient groups, respectively, in the 6MWT at 6 months post-surgery, assuming a SD of 120 m and a drop-out rate of <10%. The outcome assessor will assess participants at 10, 26 and 52 weeks post-operatively, and will remain blind to group allocation for the duration of the study, as will the statistician. Participant preference for rehabilitation mode stated prior to randomization will be accounted for in the analysis together with any baseline differences in potentially confounding characteristics as required. Discussion The HIHO Trial will be the first RCT to investigate the efficacy of inpatient rehabilitation compared to any outpatient alternative following total knee arthroplasty. Trial registration U.S. National Institutes of Health Clinical Trials Registry (http://clinicaltrials.gov) ref: NCT01583153 PMID:24341348

Progressive addition spectacle lenses: Design preferences and head movements while reading

NASA Astrophysics Data System (ADS)

Preston, Julie Lynn

In a subjective preference study, two key progressive addition lens parameters, near zone width and corridor length, were varied in a double-masked, randomized, clinical trial of 49 patients. Each subject received a complete eye examination and a new frame. Each wore 6 pairs of lenses for one week at a time and completed questionnaires relating to vision, adaptation, and satisfaction. The preferred lens was identified from the three near zone width lenses and from the three corridor length lenses. Patient characteristics were analyzed for their effect on design preference. Satisfaction ratings following a brief experience with each design were compared to ratings after one week of wear in order to ascertain the predictability of initial impressions. One lens design appeared twice in the preference trial, providing an assessment of the repeatability of the rating instrument. The lens design with the widest near zone was rated significantly lower than the other near zone width designs for nearly every question relating to vision, adaptation, and satisfaction. This lens was also least preferred of all the designs. Preferences for corridor length were evenly distributed among the three designs. Of patient characteristics, years of progressive addition lens wear and gender significantly affected design preference in this population. Initial impressions were not predictive of satisfaction after a week of wear. The rating instrument was judged to have low repeatability. In the head movement portion of the study, 18 participants from the preference study wore the three near zone width designs while reading three paragraphs of varying print size. From a 20 second recording for each of three different paragraphs with each lens, measures of head rotation and posture were collected. The amplitude of head rotation was significantly affected by print size but not by lens design. The effective zone widths on the lenses scanned by the eyes and the locations of the reading levels were calculated from the head rotation and posture data. Effective zone widths were narrower than the contour plot widths for each condition.

A randomized trial found online questionnaires supplemented by postal reminders generated a cost-effective and generalizable sample but don't forget the reminders.

PubMed

Loban, Amanda; Mandefield, Laura; Hind, Daniel; Bradburn, Mike

2017-12-01

The objective of this study was to compare the response rates, data completeness, and representativeness of survey data produced by online and postal surveys. A randomized trial nested within a cohort study in Yorkshire, United Kingdom. Participants were randomized to receive either an electronic (online) survey questionnaire with paper reminder (N = 2,982) or paper questionnaire with electronic reminder (N = 2,855). Response rates were similar for electronic contact and postal contacts (50.9% vs. 49.7%, difference = 1.2%, 95% confidence interval: -1.3% to 3.8%). The characteristics of those responding to the two groups were similar. Participants nevertheless demonstrated an overwhelming preference for postal questionnaires, with the majority responding by post in both groups. Online survey questionnaire systems need to be supplemented with a postal reminder to achieve acceptable uptake, but doing so provides a similar response rate and case mix when compared to postal questionnaires alone. For large surveys, online survey systems may be cost saving. Copyright © 2017 Elsevier Inc. All rights reserved.

Attrition during a randomized controlled trial of reduced nicotine content cigarettes as a proxy for understanding acceptability of nicotine product standards.

PubMed

Mercincavage, Melissa; Wileyto, E Paul; Saddleson, Megan L; Lochbuehler, Kirsten; Donny, Eric C; Strasser, Andrew A

2017-06-01

To determine (1) if nicotine content affects study attrition-a potential behavioral measure of acceptability-in a trial that required compliance with three levels of reduced nicotine content (RNC) cigarettes, and (2) if attrition is associated with subjective and behavioral responses to RNC cigarettes. Secondary analysis of a 35-day, parallel-design, open-label, randomized controlled trial. After a 5-day baseline period, participants were randomized to smoke for three 10-day periods: their preferred brand (control group) or RNC cigarettes with three nicotine levels in a within-subject stepdown (one group: high-moderate-low) or non-stepdown (five groups: high-low-moderate, low-moderate-high, low-high-moderate, moderate-low-high, moderate-high-low) fashion. A single site in Philadelphia, PA, USA. A total of 246 non-treatment-seeking daily smokers [mean age = 39.52, cigarettes per day (CPD) = 20.95, 68.3% white] were recruited from October 2007 to June 2013. The primary outcome was attrition. Key predictors were nicotine content transition and study period. Exploratory predictors were taste and strength subjective ratings, total puff volume and carbon monoxide (CO) boost. Covariates included: age, gender, race, education and nicotine dependence. Overall attrition was 31.3% (n = 77): 24.1% of the control and 25.0% of the stepdown RNC cigarette groups dropped out versus 44.6% of non-stepdown groups (P = 0.006). Compared with controls, attrition odds were 4.5 and 4.7 times greater among smokers transitioning from preferred and the highest RNC cigarettes to the lowest RNC cigarettes, respectively (P = 0.001 and 0.003). Providing more favorable initial taste ratings of study cigarettes decreased attrition odds by 2% (P = 0.012). The majority of participants completed a 35-day trial of varying levels of reduced nicotine content cigarettes. Participant dropout was greater for cigarettes with lower nicotine content and less in smokers reporting more favorable subjective ratings of the cigarettes. © 2017 Society for the Study of Addiction.

A Randomized Controlled Trial of a CPR Decision Support Video for Patients Admitted to the General Medicine Service.

PubMed

Merino, Aimee M; Greiner, Ryan; Hartwig, Kristopher

2017-09-01

Patient preferences regarding cardiopulmonary resuscitation (CPR) are important, especially during hospitalization when a patient's health is changing. Yet many patients are not adequately informed or involved in the decision-making process. We examined the effect of an informational video about CPR on hospitalized patients' code status choices. This was a prospective, randomized trial conducted at the Minneapolis Veterans Affairs Health Care System in Minnesota. We enrolled 119 patients, hospitalized on the general medicine service, and at least 65 years old. The majority were men (97%) with a mean age of 75. A video described code status choices: full code (CPR and intubation if required), do not resuscitate (DNR), and do not resuscitate/do not intubate (DNR/DNI). Participants were randomized to watch the video (n = 59) or usual care (n = 60). The primary outcome was participants' code status preferences. Secondary outcomes included a questionnaire designed to evaluate participants' trust in their healthcare team and knowledge and perceptions about CPR. Participants who viewed the video were less likely to choose full code (37%) compared to participants in the usual care group (71%) and more likely to choose DNR/DNI (56% in the video group vs. 17% in the control group) ( < 0.00001). We did not see a difference in trust in their healthcare team or knowledge and perceptions about CPR as assessed by our questionnaire. Hospitalized patients who watched a video about CPR and code status choices were less likely to choose full code and more likely to choose DNR/DNI. © 2017 Society of Hospital Medicine

Bristol girls dance project feasibility study: using a pilot economic evaluation to inform design of a full trial

PubMed Central

Powell, Jane E; Carroll, Fran E; Sebire, Simon J; Haase, Anne M; Jago, Russell

2013-01-01

Background There is currently little guidance for pilot trial economic evaluation where health outcomes and costs are influenced by a range of wider determinants and factors. Objectives This article presents the findings of a pilot economic evaluation study running alongside the Bristol Girls Dance Project (BGDP) feasibility study. Design 3-arm, cluster randomised, controlled pilot trial and economic evaluation. 7 schools (n=210) from the Bristol and greater Bristol area, UK were randomly allocated to the intervention arm 3 schools (n=90) and the control arm 4 schools (n=120). Intervention Girls aged 11–12 years with parental consent were provided with two, 90 min dance sessions per week for 9 weeks at school facilities. Economic outcome measures Programme costs and girls’ preferences for attributes of dance and preferences for competing leisure time activities were measured. Results The mainstream average cost of the BGDP programme (not including research, control and dance teacher training costs) per school was $2126.40, £1329 and €1555 and per participant was $70.90, £44.31 and €51.84 in 2010–2011 prices. Discrete choice experiment (DCE) methods are acceptable to girls of this age indicating time available for other leisure activities on dance class days is the attribute girls valued most and 2 h leisure time remaining preferred to 3 h. Conclusions This pilot study indicates that providing full cost data for a future trial of the BGDP programme is feasible and practical. There is no evidence from preference data to support adjustment to intervention design. A future economic evaluation is likely to be successful utilising the resource use checklist developed. The importance of categorising separately resources used to develop, prepare, deliver and maintain the programme to estimate mainstream costs accurately is demonstrated. PMID:24362013

IMPROVDENT: improving dentures for patient benefit. A crossover randomised clinical trial comparing impression materials for complete dentures.

PubMed

Gray, Janine C; Navarro-Coy, Nuria; Pavitt, Sue H; Hulme, Claire; Godfrey, Mary; Craddock, Helen L; Brunton, Paul A; Brown, Sarah; Dillon, Sean; Dukanovic, Gillian; Fernandez, Catherine; Wright, Jonathan; Collier, Howard; Swithenbank, Shirley; Lee, Carol; Hyde, T Paul

2012-08-31

According to the UK Adult Dental Health Survey (2009) 15% of adults aged 65-74, 30% aged 75-84 and 47% aged >85 years are edentulous and require complete dentures. Patients' quality of life and nutrition status are affected by poor dentures. The quality of the dental impression is the most important issue for improving the fit and comfort of new dentures. There is paucity of RCT evidence for which impression material is best for complete dentures construction. This study aims to compare two impression materials for effectiveness and cost effectiveness. IMPROVDENT is a double-blind crossover trial comparing the use of alginate and silicone, two commonly used denture impression materials, in terms of patient preference and cost-effectiveness. Eighty five edentulous patients will be recruited and provided with two sets of dentures, similar in all aspects except for the impression material used (alginate or silicone). Patients will try both sets of dentures for a two-week period, unadjusted, to become accustomed to the feel of the new dentures (habituation period). Patients will then wear each set of dentures for a period of 8 weeks (in random order) during which time the dentures will be adjusted for optimum comfort. Finally, patients will be given both sets of dentures for a further two weeks to wear whichever denture they prefer (confirmation period).Patients will be asked about quality of life and to rate dentures on function and comfort at the end of each trial period and asked which set they prefer at the end of the habituation period (unadjusted denture preference) and confirmation period (adjusted denture preference). A health economic evaluation will estimate incremental cost-effectiveness ratios of producing dentures from the two materials. A qualitative study will investigate the impact of dentures on behaviour and quality of life. IMPROVDENT is funded by NIHR RfPB (PB-PG-0408-16300). This trial aims to provide evidence on the costs and quality of dentures cast from two different commonly used impression materials; the intention is to significantly impact on the quality of denture production within NHS dentistry. ISRCTN Register: ISRCTN01528038 UKCRN Portfolio ID: 8305.

Waiting list randomized controlled trial within a case-finding design: methodological considerations.

PubMed

Ronaldson, Sarah; Adamson, Joy; Dyson, Lisa; Torgerson, David

2014-10-01

Randomized controlled trials (RCTs) are widely used in health care research to provide high-quality evidence of effectiveness of an intervention. However, sometimes a study does not require an RCT in order to answer its primary objective; a case-finding design may be more appropriate. The aim of this paper was to introduce a new study design that nests a waiting list RCT within a case-finding study. An example of the new study design is the DOC Study, which primarily aims to determine the diagnostic accuracy of lung function tests for chronic obstructive pulmonary disease. It also investigates the impact of lung function tests on smoking behaviour through use of a waiting list design. The first step of the study design is to obtain participants' consent. Individuals are then randomized to one of two groups; either the 'intervention now' group or the 'intervention later' group, that is, participants are placed on a waiting list. All participants receive the same intervention; the only difference between the groups is the timing of the intervention. The design addresses patient preference issues and recruitment issues that can arise in other trial designs. Potential limitations include differential attrition between study groups and potential demoralization for the 'intervention later' group. The 'waiting list case-finding trial' design is a valuable method that could be applied to case-finding studies; the design enables the case-finding component of a study to be maintained while simultaneously exploring additional hypotheses through conducting a trial. © 2014 John Wiley & Sons, Ltd.

Dietary interventions, lifestyle changes, and dietary supplements in preventing gestational diabetes mellitus: a literature review.

PubMed

Facchinetti, Fabio; Dante, Giulia; Petrella, Elisabetta; Neri, Isabella

2014-11-01

Gestational diabetes mellitus (GDM) is associated with increased rates of fetal morbidity and mortality, both during the pregnancy and in the postnatal life. Current treatment of GDM includes diet with or without medications, but this management is expensive and poorly cost-effective for the health care systems. Strategies to prevent such condition would be preferable with respect to its treatment. The aim of this literature review was to evaluate studies reporting the efficacy of the most used approaches to prevent GDM as well as evidences of efficacy and safety of dietary supplementations. Systematic literature searches were performed in electronic databases, covering the period January 1983 to April 2014. Randomized controlled clinical trials were included. Quality of the articles was evaluated with the Jadad scale. We did not evaluate those articles that were already entered in the most recent systematic reviews, and we completed the research with the trials published thereafter. Of 55 articles identified, 15 randomized controlled trials were eligible. Quality and heterogeneity of the studies cannot allow firm conclusions. Anyway, trials in which only intake or expenditure has been targeted mostly reported negative results. On the contrary, combined lifestyle programs including diet control (orienting food intake, restricting energy intake) associated with moderate but continuous physical activity exhibit better efficacy in reducing GDM prevalence. The results from dietary supplements with myoinositol or probiotics are promising. The actual evidences provide enough arguments for implementing large-scale, high-quality randomized controlled trials looking at the possible benefits of these new approaches for preventing GDM.

What Do We Really Know About the Safety of Tai Chi?: A Systematic Review of Adverse Event Reports in Randomized Trials

PubMed Central

Wayne, Peter M.; Berkowitz, Danielle L.; Litrownik, Daniel E.; Buring, Julie E.; Yeh, Gloria Y.

2014-01-01

Objective Systematically review frequency and quality of adverse event (AE) reports in randomized clinical trials (RCTs) of Tai Chi (TC). Data Sources Electronic searches of PubMed/MEDLINE and additional databases from inception through March 2013 of English-language RCTs. Search terms were tai chi, taiji, tai chi chuan. Data were independently extracted by two investigators. Study Selection We included all available randomized controlled trials (RCTs) that were published in English and used Tai Chi as an intervention. Inclusion and exclusion of studies were reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data Extraction Eligible RCTs were categorized with respect to AE reporting: 1) No mention of protocols for monitoring AEs or reports of AEs; 2) Reports of AEs either with or without explicit protocols for monitoring AEs. Data Synthesis 153 eligible RCTs were identified, most targeting older adults. Only 50 eligible trials (33%) included reporting of AEs, and of these, only 18 trials (12% overall) also reported an explicit AE monitoring protocol. Protocols varied with respect to rigor of systematic monitoring in both Tai Chi and comparison groups. Reported AEs were typically minor and expected, and primarily musculoskeletal related (e.g., knee and back pain); no intervention-related serious AEs were reported. Conclusions Tai Chi is unlikely to result in serious adverse events, but may be associated with minor musculoskeletal aches and pains. However, poor and inconsistent reporting of AEs greatly limits the conclusions that can be drawn regarding the safety of Tai Chi. PMID:24878398

Improvdent: Improving dentures for patient benefit. A crossover randomised clinical trial comparing impression materials for complete dentures

PubMed Central

2012-01-01

Background According to the UK Adult Dental Health Survey (2009) 15% of adults aged 65–74, 30% aged 75–84 and 47% aged >85 years are edentulous and require complete dentures. Patients’ quality of life and nutrition status are affected by poor dentures. The quality of the dental impression is the most important issue for improving the fit and comfort of new dentures. There is paucity of RCT evidence for which impression material is best for complete dentures construction. This study aims to compare two impression materials for effectiveness and cost effectiveness. Methods/Design IMPROVDENT is a double-blind crossover trial comparing the use of alginate and silicone, two commonly used denture impression materials, in terms of patient preference and cost-effectiveness. Eighty five edentulous patients will be recruited and provided with two sets of dentures, similar in all aspects except for the impression material used (alginate or silicone). Patients will try both sets of dentures for a two-week period, unadjusted, to become accustomed to the feel of the new dentures (habituation period). Patients will then wear each set of dentures for a period of 8 weeks (in random order) during which time the dentures will be adjusted for optimum comfort. Finally, patients will be given both sets of dentures for a further two weeks to wear whichever denture they prefer (confirmation period). Patients will be asked about quality of life and to rate dentures on function and comfort at the end of each trial period and asked which set they prefer at the end of the habituation period (unadjusted denture preference) and confirmation period (adjusted denture preference). A health economic evaluation will estimate incremental cost-effectiveness ratios of producing dentures from the two materials. A qualitative study will investigate the impact of dentures on behaviour and quality of life. Funding: IMPROVDENT is funded by NIHR RfPB (PB-PG-0408-16300). Discussion This trial aims to provide evidence on the costs and quality of dentures cast from two different commonly used impression materials; the intention is to significantly impact on the quality of denture production within NHS dentistry. Trial Registration ISRCTN Register: ISRCTN01528038 UKCRN Portfolio ID: 8305 PMID:22937901

Equivalence of Nasal and Oronasal Masks during Initial CPAP Titration for Obstructive Sleep Apnea Syndrome

PubMed Central

Teo, Ming; Amis, Terence; Lee, Sharon; Falland, Karina; Lambert, Stephen; Wheatley, John

2011-01-01

Study Objective: Continuous positive airway pressure (CPAP) titration studies are commonly performed using a nasal mask but some patients may prefer a full-face or oronasal mask. There is little evidence regarding the equivalence of different mask interfaces used to initiate treatment. We hypothesized that oronasal breathing when using an oronasal mask increases upper airway collapsibility and that a higher pressure may be required to maintain airway patency. We also assessed patient preferences for the 2 mask interfaces. Design: Prospective, randomized, cross-over design with 2 consecutive CPAP titration nights. Setting: Accredited laboratory in a university hospital. Patients or Participants: Twenty-four treatment-naive subjects with obstructive sleep apnea syndrome and respiratory disturbance index of greater than 15 events per hour. Interventions: CPAP titration was performed using an auto-titrating machine with randomization to a nasal or oronasal mask, followed by a second titration night using the alternate mask style. Measurements and Results: There was no significant difference in the mean pressures determined between nasal and oronasal masks, although 43% of subjects had nasal-to-oronasal mask-pressure differences of 2 cm H2O or more. Residual respiratory events, arousals, and measured leak were all greater with the oronasal mask. Seventy-nine percent of subjects preferred the nasal mask. Conclusions: Patients with obstructive sleep apnea syndrome can generally switch between nasal and oronasal masks without changing machine pressure, although there are individual differences that may be clinically significant. Measured leak is greater with the oronasal mask. Most patients with obstructive sleep apnea syndrome prefer a nasal mask as the interface for initiation of CPAP. Clinical Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR). ACTRN: ACTRN12611000243910. URL: http://www.ANZCTR.org.au/ACTRN12611000243910.aspx Citation: Teo M; Amis T; Lee S; Falland K; Lambert S; Wheatley J. Equivalence of nasal and oronasal masks during initial CPAP titration for obstructive sleep apnea syndrome. SLEEP 2011;34(7):951-955. PMID:21731145

Show Me My Health Plans: a study protocol of a randomized trial testing a decision support tool for the federal health insurance marketplace in Missouri.

PubMed

Politi, Mary C; Barker, Abigail R; Kaphingst, Kimberly A; McBride, Timothy; Shacham, Enbal; Kebodeaux, Carey S

2016-02-16

The implementation of the ACA has improved access to quality health insurance, a necessary first step to improving health outcomes. However, access must be supplemented by education to help individuals make informed choices for plans that meet their individual financial and health needs. Drawing on a model of information processing and on prior research, we developed a health insurance decision support tool called Show Me My Health Plans. Developed with extensive stakeholder input, the current tool (1) simplifies information through plain language and graphics in an educational component; (2) assesses and reviews knowledge interactively to ensure comprehension of key material; (3) incorporates individual and/or family health status to personalize out-of-pocket cost estimates; (4) assesses preferences for plan features; and (5) helps individuals weigh information appropriate to their interests and needs through a summary page with "good fit" plans generated from a tailored algorithm. The current study will evaluate whether the online decision support tool improves health insurance decisions compared to a usual care condition (the healthcare.gov marketplace website). The trial will include 362 individuals (181 in each group) from rural, suburban, and urban settings within a 90 mile radius around St. Louis. Eligibility criteria includes English-speaking individuals 18-64 years old who are eligible for the ACA marketplace plans. They will be computer randomized to view the intervention or usual care condition. Presenting individuals with options that they can understand tailored to their needs and preferences could help improve decision quality. By helping individuals narrow down the complexity of health insurance plan options, decision support tools such as this one could prepare individuals to better navigate enrollment in a plan that meets their individual needs. The randomized trial was registered in clinicaltrials.gov (NCT02522624) on August 6, 2015.

Efficacy of Different Types of Mobilization Techniques in Patients With Primary Adhesive Capsulitis of the Shoulder: A Systematic Review.

PubMed

Noten, Suzie; Meeus, Mira; Stassijns, Gaetane; Van Glabbeek, Francis; Verborgt, Olivier; Struyf, Filip

2016-05-01

To systematically review the literature for efficacy of isolated articular mobilization techniques in patients with primary adhesive capsulitis (AC) of the shoulder. PubMed and Web of Science were searched for relevant studies published before November 2014. Additional references were identified by manual screening of the reference lists. All English language randomized controlled trials evaluating the efficacy of mobilization techniques on range of motion (ROM) and pain in adult patients with primary AC of the shoulder were included in this systematic review. Twelve randomized controlled trials involving 810 patients were included. Two reviewers independently screened the articles, scored methodologic quality, and extracted data for analysis. The review was conducted and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. All studies were assessed in duplicate for risk of bias using the Physiotherapy Evidence Database Scale for randomized controlled trials. The efficacy of 7 different types of mobilization techniques was evaluated. Angular mobilization (n=2), Cyriax approach (n=1), and Maitland technique (n=6) showed improvement in pain score and ROM. With respect to translational mobilizations (n=1), posterior glides are preferred to restore external rotation. Spine mobilizations combined with glenohumeral stretching and both angular and translational mobilization (n=1) had a superior effect on active ROM compared with sham ultrasound. High-intensity mobilization (n=1) showed less improvement in the Constant Murley Score than a neglect group. Finally, positive long-term effects of the Mulligan technique (n=1) were found on both pain and ROM. Overall, mobilization techniques have beneficial effects in patients with primary AC of the shoulder. Because of preliminary evidence for many mobilization techniques, the Maitland technique and combined mobilizations seem recommended at the moment. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Nasogastric tube versus gastrostomy tube for gastric decompression in abdominal surgery: a prospective, randomized trial comparing patients' tube-related inconvenience.

PubMed

Hoffmann, S; Koller, M; Plaul, U; Stinner, B; Gerdes, B; Lorenz, W; Rothmund, M

2001-11-01

Perioperative decompression of the stomach is still a common procedure and can be achieved using either nasogastric tubes (NTs) or gastrostomy tubes (GTs). While both procedures appear to be equally effective, some authors believe that NTs are less convenient for patients than GTs. However, to date, no reliable prospective data are available on this issue. We conducted a prospective, randomized trial comparing NTs versus GTs with a total of 110 patients undergoing elective colon surgery. The primary outcome measure was the patient's tube-related inconvenience and pain, assessed in a standardized interview on day 2 after surgery and quantified by means of a visual-analog scale (VAS). A questionnaire including the EORTC QLQ-C30 and additional items regarding retrospective tube-related judgements was administered on the day of discharge and 4 weeks after discharge. Secondary endpoints were the therapy-related morbidity and general complications. When patients were asked which of their drainage tubes (all patients had three or four drainage tubes, such as decompression drains, urinary drains, central venous line) was most inconvenient, 43% (CI 33-53%) in the NT group reported that the NT was most inconvenient, while only 4% (CI 1-10%) of the GT patients judged the GT most inconvenient ( P<0.001, Chi(2) test). This effect was also found in VAS ratings of inconvenience and discomfort ( P<0.01). Also postoperatively (p.o.), NT patients evidenced less preference for their tube system (day 2 p.o.: 71%, CI 61-80%; 4 weeks p.o.: 66%, CI 56-75%) than did GT patients (day 2 p.o.: 94%, CI 88-98%; 4 weeks p.o.: 91% CI 84-96%); again, these differences were statistically significant ( P<0.02; Chi(2) test). No differences between groups emerged regarding global quality of life or conventional clinical outcomes. This prospective randomized trial supports the clinical observation that NT causes more subjective inconvenience than GT. In cases when a prolonged postoperative ileus is expected, decisions for a prophylactic decompressing tube system have to weigh up the possibilities of different averse clinical as well as subjective outcomes. It is then preferable to include patients' preferences in the individual decision making process (shared-decision making).

Resistant Hypertension: Time to Consider the Best Fifth Anti-Hypertensive Treatment.

PubMed

Pio-Abreu, Andrea; Drager, Luciano F

2018-06-16

Resistant hypertension (RH) is a growing clinical condition worldwide associated with target-organ damage and poor prognosis compared to non-resistant counterparts. The purpose of this review is to perform a critical evaluation of preferable drug choices for managing RH highlighting the evidence that significant proportion of patients remained uncontrolled despite using four anti-hypertensive drugs. Until recently, the fourth drug therapy was main derived from personal opinion or small interventional studies. The recent data derived from two multicentric randomized trials, namely PATHWAY-2 and ReHOT, pointed spironolactone as the preferable fourth drug therapy in patients with confirmed RH as compared to bisoprolol and doxazosin (PATHWAY-2) as well as clonidine (ReHOT). However, significant proportion of patients (especially observed in ReHOT trial that used 24-h ambulatory blood pressure monitoring) did not achieve optimal blood pressure with the fourth drug. This finding underscores the need of new approaches and treatment options in this important research area. The current evidence pointed that significant proportion of RH patients are requiring more than four drugs for controlling BP. This statement is particularly true considering the new criteria proposed by the 2017 Guidelines for diagnosing RH (> 130 × 80 mmHg). New combinations, drugs, or treatments should be tested aiming to reduce the RH burden. Based on the aforementioned multicentric trials, we proposed the first five preferable anti-hypertensive classes in the overall context of RH.

Web-Based Communication Strategies Designed to Improve Intention to Minimize Risk for Colorectal Cancer: Randomized Controlled Trial

PubMed Central

Flight, Ingrid; Zajac, Ian T; Turnbull, Deborah; Young, Graeme P; Olver, Ian

2018-01-01

Background People seek information on the Web for managing their colorectal cancer (CRC) risk but retrieve much personally irrelevant material. Targeting information pertinent to this cohort via a frequently asked question (FAQ) format could improve outcomes. Objective We identified and prioritized colorectal cancer information for men and women aged 35 to 74 years (study 1) and built a website containing FAQs ordered by age and gender. In study 2, we conducted a randomized controlled trial (RCT) to test whether targeted FAQs were more influential on intention to act on CRC risk than the same information accessed via a generic topic list. Secondary analyses compared preference for information delivery, usability, relevance, and likelihood of recommendation of FAQ and LIST websites. Methods Study 1 determined the colorectal cancer information needs of Australians (N=600) by sex and age group (35-49, 50-59, 60-74) through a Web-based survey. Free-text responses were categorized as FAQs: the top 5 issues within each of the 6 cohorts were identified. Study 2 (N=240) compared the impact of presentation as targeted FAQ links to information with links presented as a generic list (LIST) and a CONTROL (no information) condition. We also tested preference for presentation of access to information as FAQ or LIST by adding a CHOICE condition (a self-selected choice of FAQs or a list of information topics). Results Study 1 showed considerable consistency in information priorities among all 6 cohorts with 2 main concerns: treatment of CRC and risk factors. Some differences included a focus on general risk factors, excluding diet and lifestyle, in the younger cohort, and on the existence of a test for CRC in the older cohorts. Study 2 demonstrated that, although respondents preferred information access ordered by FAQs over a list, presentation in this format had limited impact on readiness to act on colorectal cancer risk compared with the list or a no-information control (P=.06). Both FAQ and LIST were evaluated as equally usable. Those aged 35 to 49 years rated the information less relevant to them and others in their age group, and information ordered by FAQs was rated, across all age groups and both sexes, as less relevant to people outside the age group targeted within the FAQs. Conclusions FAQs are preferred over a list as a strategy for presenting access to information about CRC. They may improve intention to act on risk, although further research is required. Future research should aim to identify better the characteristics of information content and presentation that optimize perceived relevance and fully engage the target audience. Trial Registration Australian New Zealand Clinical Trials Registry: ACTRN12618000137291; https://www.anzctr.org. au/Trial/Registration/TrialReview.aspx?id=374129 (Archived by WebCite at http://www.webcitation.org/6x2Mr6rPC) PMID:29434013

Prolonged conservative treatment or 'early' surgery in sciatica caused by a lumbar disc herniation: rationale and design of a randomized trial [ISRCT 26872154

PubMed Central

Peul, Wilco C; van Houwelingen, Hans C; van der Hout, Wilbert B; Brand, Ronald; Eekhof, Just AH; Tans, Joseph ThJ; Thomeer, Ralph TWM; Koes, Bart W

2005-01-01

Background The design of a randomized multicenter trial is presented on the effectiveness of a prolonged conservative treatment strategy compared with surgery in patients with persisting intense sciatica (lumbosacral radicular syndrome). Methods/design Patients presenting themselves to their general practitioner with disabling sciatica lasting less than twelve weeks are referred to the neurology outpatient department of one of the participating hospitals. After confirmation of the diagnosis and surgical indication MRI scanning is performed. If a distinct disc herniation is discerned which in addition covers the clinically expected site the patient is eligible for randomization. Depending on the outcome of the randomization scheme the patient will either be submitted to prolonged conservative care or surgery. Surgery will be carried out according to the guidelines and between six and twelve weeks after onset of complaints. The experimental therapy consists of a prolonged conservative treatment under supervision of the general practitioner, which may be followed by surgical intervention in case of persisting or progressive disability. The main primary outcome measure is the disease specific disability of daily functioning. Other primary outcome measures are perceived recovery and intensity of legpain. Secondary outcome measures encompass severity of complaints, quality of life, medical consumption, absenteeism, costs and preference. The main research question will be answered at 12 months after randomization. The total follow-up period covers two years. Discussion Evidence is lacking concerning the optimal treatment of lumbar disc induced sciatica. This pragmatic randomized trial, focusses on the 'timing' of intervention, and will contribute to the decision of the general practictioner and neurologist, regarding referral of patients for surgery. PMID:15707491

Comparative Effectiveness of Blood Pressure-lowering Drugs in Patients who have Already Suffered From Stroke

PubMed Central

Wang, Wei-Ting; You, Li-Kai; Chiang, Chern-En; Sung, Shih-Hsien; Chuang, Shao-Yuan; Cheng, Hao-Min; Chen, Chen-Huan

2016-01-01

Abstract Hypertension is the most important risk factor for stroke and stroke recurrence. However, the preferred blood pressure (BP)-lowering drug class for patients who have suffered from a stroke has yet to be determined. To investigate the relative effects of BP-lowering therapies [angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blockers (ARB), β blockers, calcium channel blockers (CCBs), diuretics, and combinations of these drugs] in patients with a prior stroke history, we performed a systematic review and meta-analysis using both traditional frequentist and Bayesian random-effects models and meta-regression of randomized controlled trials (RCTs) on the outcomes of recurrent stroke, coronary heart disease (CHD), and any major adverse cardiac and cerebrovascular events (MACCE). Trials were identified from searches of published hypertension guidelines, electronic databases, and previous systematic reviews. Fifteen RCTs composed of 39,329 participants with previous stroke were identified. Compared with the placebo, only ACEI along with diuretics significantly reduced recurrent stroke events [odds ratio (OR) = 0.54, 95% credibility interval (95% CI) 0.33–0.90]. On the basis of the distribution of posterior probabilities, the treatment ranking consistently identified ACEI along with diuretics as the preferred BP-lowering strategy for the reduction of recurrent stroke and CHD (31% and 35%, respectively). For preventing MACCE, diuretics appeared to be the preferred agent for stroke survivors (34%). Moreover, the meta-regression analysis failed to demonstrate a statistical significance between BP reduction and all outcomes (P = 0.1618 for total stroke, 0.4933 for CHD, and 0.2411 for MACCE). Evidence from RCTs supports the use of diuretics-based treatment, especially when combined with ACEI, for the secondary prevention of recurrent stroke and any vascular events in patients who have suffered from stroke. PMID:27082571

Participants' preference for type of leaflet used to feed back the results of a randomised trial: a survey.

PubMed

Brealey, Stephen; Andronis, Lazaros; Dennis, Laura; Atwell, Christine; Bryan, Stirling; Coulton, Simon; Cox, Helen; Cross, Ben; Fylan, Fiona; Garratt, Andrew; Gilbert, Fiona; Gillan, Maureen; Hendry, Maggie; Hood, Kerenza; Houston, Helen; King, David; Morton, Veronica; Robling, Michael; Russell, Ian; Wilkinson, Clare

2010-12-01

Hundreds of thousands of volunteers take part in medical research, but many will never hear from researchers about what the study revealed. There is a growing demand for the results of randomised trials to be fed back to research participants both for ethical research practice and for ensuring their co-operation in a trial. This study aims to determine participants' preferences for type of leaflet (short versus long) used to summarise the findings of a randomised trial; and to test whether certain characteristics explained participants' preferences. 553 participants in a randomised trial about General Practitioners' access to Magnetic Resonance Imaging for patients presenting with suspected internal derangement of the knee were asked in the final follow-up questionnaire whether they would like to be fed back the results of the trial. Participants who agreed to this were included in a postal questionnaire survey asking about their preference, if any, between a short and a long leaflet and what it was about the leaflet that they preferred. Multinomial logistic regression was used to test whether certain demographics of responding participants along with treatment group explained whether a participant had a preference for type of leaflet or no preference. Of the participants who returned the final follow-up questionnaire, 416 (88%) agreed to receive the results of the trial. Subsequently 132 (32%) participants responded to the survey. Most participants preferred the longer leaflet (55%) and the main reasons for this were the use of technical information (94%) and diagrams (89%). There was weak evidence to suggest that gender might explain whether participants have a preference for type of leaflet or not (P = 0.084). Trial participants want to receive feed back about the results and appear to prefer a longer leaflet. Males and females might require information to be communicated to them differently and should be the focus of further research. The trial is registered with http://www.isrctn.org/ and ID is ISRCTN76616358.

Effectiveness of aerobic gymnastic exercise on stress, fatigue, and sleep quality during postpartum: A pilot randomized controlled trial.

PubMed

Yang, Chiu-Ling; Chen, Chung-Hey

2018-01-01

Gymnastics is a preferable safe exercise for postnatal women performing regularly. The aim of this pilot randomized controlled trial was to determine whether the aerobic gymnastic exercise improves stress, fatigue, sleep quality and depression in postpartum women. Single-blinded, randomized controlled trial held from December 2014 until September 2015. Postnatal clinic of a medical center in southern Taiwan. 140 eligible postnatal women were systematically assigned, with a random start to experimental (n=70) or a control (n=70) group. Engage in aerobic gymnastic exercise at least three times (15min per section) a week for three months using compact disc in the home. Perceived Stress Scale, Postpartum Fatigue Scale, Postpartum Sleep Quality Scale, and Edinburgh Postnatal Depression Scale. In a two-way ANOVA with repeated measures, the aerobic gymnastic exercise group showed significant decrease in fatigue after practicing exercise 4 weeks and the positive effects extended to the 12-week posttests. Paired t-tests revealed that aerobic gymnastic exercise participants had improved significantly in perceived stress and fatigue after 4 weeks gymnastic exercise; these positive effects extended to the 12-week posttests. In addition, the changes in physical symptoms-related sleep inefficiency after 12 weeks gymnastic exercise were significantly decreased in the experimental group compared with the control group. The findings can be used to encourage postnatal women to perform moderate-intensity gymnastic exercise in their daily life to reduce their stress, fatigue and improve sleep quality. Copyright © 2017 Elsevier Ltd. All rights reserved.

Physical activity as an aid to smoking cessation during pregnancy (LEAP) trial: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Many women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA) interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP) trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date. Methods/design The LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy), and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation) or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations). The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome. Discussion This trial will assess whether a PA intervention is effective when used for smoking cessation during pregnancy. Trial registration ISRCTN48600346 PMID:23035669

Closure of abdominal wounds by adhesive strips: a clinical trial.

PubMed Central

Webster, D J; Davis, P W

1975-01-01

In a randomized trial of wound closure in 512 abdominal wounds, wounds were closed with either reinforced Steristrip skin closures or interrupted silk sutures. Comparisons were made of wound pain and discomfort, wound infection, discharge, redness, width, and skin reaction. The causes of peeling of the tapes were assessed. The results showed that tapes were significantly more comfortable and that patients preferred them to sutures (P less than 0.01), but wide scars occurred more often. There was no difference in rates of wound infection and no case of allergy to the tapes was seen. Closure of abdominal wounds by these tapes is a satisfactory procedure that could be used more extensively. PMID:1100188

Synchronized personalized music audio-playlists to improve adherence to physical activity among patients participating in a structured exercise program: a proof-of-principle feasibility study.

PubMed

Alter, David A; O'Sullivan, Mary; Oh, Paul I; Redelmeier, Donald A; Marzolini, Susan; Liu, Richard; Forhan, Mary; Silver, Michael; Goodman, Jack M; Bartel, Lee R

2015-01-01

Preference-based tempo-pace synchronized music has been shown to reduce perceived physical activity exertion and improve exercise performance. The extent to which such strategies can improve adherence to physical activity remains unknown. The objective of the study is to explore the feasibility and efficacy of tempo-pace synchronized preference-based music audio-playlists on adherence to physical activity among cardiovascular disease patients participating in a cardiac rehabilitation. Thirty-four cardiac rehabilitation patients were randomly allocated to one of two strategies: (1) no music usual-care control and (2) tempo-pace synchronized audio-devices with personalized music playlists + usual-care. All songs uploaded onto audio-playlist devices took into account patient personal music genre and artist preferences. However, actual song selection was restricted to music whose tempos approximated patients' prescribed exercise walking/running pace (steps per minute) to achieve tempo-pace synchrony. Patients allocated to audio-music playlists underwent further randomization in which half of the patients received songs that were sonically enhanced with rhythmic auditory stimulation (RAS) to accentuate tempo-pace synchrony, whereas the other half did not. RAS was achieved through blinded rhythmic sonic-enhancements undertaken manually to songs within individuals' music playlists. The primary outcome consisted of the weekly volume of physical activity undertaken over 3 months as determined by tri-axial accelerometers. Statistical methods employed an intention to treat and repeated-measures design. Patients randomized to personalized audio-playlists with tempo-pace synchrony achieved higher weekly volumes of physical activity than did their non-music usual-care comparators (475.6 min vs. 370.2 min, P  < 0.001). Improvements in weekly physical activity volumes among audio-playlist recipients were driven by those randomized to the RAS group which attained weekly exercise volumes that were nearly twofold greater than either of the two other groups (average weekly minutes of physical activity of 631.3 min vs. 320 min vs. 370.2 min, personalized audio-playlists with RAS vs. personalized audio-playlists without RAS vs. non-music usual-care controls, respectively, P  < 0.001). Patients randomized to music with RAS utilized their audio-playlist devices more frequently than did non-RAS music counterparts ( P  < 0.001). The use of tempo-pace synchronized preference-based audio-playlists was feasibly implemented into a structured exercise program and efficacious in improving adherence to physical activity beyond the evidence-based non-music usual standard of care. Larger clinical trials are required to validate these findings. ClinicalTrials.gov ID (NCT01752595).

Association between berries intake and cardiovascular diseases risk factors: a systematic review with meta-analysis and trial sequential analysis of randomized controlled trials.

PubMed

Luís, Ângelo; Domingues, Fernanda; Pereira, Luísa

2018-02-21

The main goal of this work was to clarify the effects of the consumption of berries on cardiovascular disease (CVD) risk factors by performing a systematic review according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) statement, followed by a meta-analysis and a trial sequential analysis (TSA) of randomized controlled trials (RCTs). The electronic search was conducted in PubMed, Scopus, SciELO, Web of Science and Cochrane Library between April and June 2016. To be included, RCTs had to report 1 or more of the following outcomes: total cholesterol (TC), HDL-cholesterol (HDL), LDL-cholesterol (LDL), triglycerides (TG), blood pressure (BP), C-reactive protein (CRP), tumour necrosis factor-α (TNF-α), interleukin-6 (IL-6), vascular cell adhesion molecule-1 (VCAM), intercellular adhesion molecule-1 (ICAM), glucose, insulin, apolipoprotein A-I (Apo A-I) or apolipoprotein B (Apo B). It was observed that the intake of berries reduces TC, LDL, TG, and BP while increasing the level of HDL, suggesting a beneficial effect on the control of CVDs' risk factors. Thus, the intake of berries as nutraceuticals or functional foods could be suggested for the prevention and control of CVDs.

Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Screening can reduce colorectal cancer (CRC) incidence and mortality. However, screening is underutilized in vulnerable patient populations, particularly among Latinos. Patient-directed decision aids can increase CRC screening knowledge, self-efficacy, and intent; however, their effect on actual screening test completion tends to be modest. This is probably because decision aids do not address some of the patient-specific barriers that prevent successful completion of CRC screening in these populations. These individual barriers might be addressed though patient navigation interventions. This study will test a combined decision aid and patient navigator intervention on screening completion in diverse populations of vulnerable primary care patients. Methods/Design We will conduct a multisite, randomized controlled trial with patient-level randomization. Planned enrollment is 300 patients aged 50 to 75 years at average CRC risk presenting for appointments at two primary clinics in North Carolina and New Mexico. Intervention participants will view a video decision aid immediately before the clinic visit. The 14 to 16 minute video presents information about fecal occult blood tests and colonoscopy and will be viewed on a portable computer tablet in English or Spanish. Clinic-based patient navigators are bilingual and bicultural and will provide both face-to-face and telephone-based navigation. Control participants will view an unrelated food safety video and receive usual care. The primary outcome is completion of a CRC screening test at six months. Planned subgroup analyses include examining intervention effectiveness in Latinos, who will be oversampled. Secondarily, the trial will evaluate the intervention effects on knowledge of CRC screening, self-efficacy, intent, and patient-provider communication. The study will also examine whether patient ethnicity, acculturation, language preference, or health insurance status moderate the intervention effect on CRC screening. Discussion This pragmatic randomized controlled trial will test a combined decision aid and patient navigator intervention targeting CRC screening completion. Findings from this trial may inform future interventions and implementation policies designed to promote CRC screening in vulnerable patient populations and to reduce screening disparities. Clinical trial registration ClinicalTrials.gov NCT02054598. PMID:25004983

Comparing the Efficacy, Mask Leak, Patient Adherence, and Patient Preference of Three Different CPAP Interfaces to Treat Moderate-Severe Obstructive Sleep Apnea.

PubMed

Rowland, Sharn; Aiyappan, Vinod; Hennessy, Cathy; Catcheside, Peter; Chai-Coezter, Ching Li; McEvoy, R Doug; Antic, Nick A

2018-01-15

To determine if the type of continuous positive airway pressure (CPAP) mask interface influences CPAP treatment efficacy, adherence, side effects, comfort and sleep quality in patients with moderate-severe obstructive sleep apnea (OSA). This took place in a hospital-based tertiary sleep disorders unit. It is a prospective, randomized, crossover trial comparing three CPAP interfaces: nasal mask (NM), nasal mask plus chinstrap (NM-CS) and oronasal mask (ONM) each tried in random order, for 4 weeks. After each 4-week period, patient outcomes were assessed. Participants had a new diagnosis of obstructive sleep apneas. Forty-eight patients with moderate-severe OSA (32 males, mean ± standard deviation apnea-hypopnea index (AHI) 55.6 ± 21.1 events/h, age 54.9 ± 13.1 years, body mass index 35.8 ± 7.2 kg/m 2 ) were randomized. Thirty-five participants completed the full study, with complete data available for 34 patients. There was no statistically significant difference in CPAP adherence; however, residual AHI was higher with ONM than NM and NM-CS (residual AHI 7.1 ± 7.7, 4.0 ± 3.1, 4.2 ± 3.7 events/h respectively, main effect P = .001). Patient satisfaction and quality of sleep were higher with the NM and NM-CS than the ONM. Fewer leak and mask fit problems were reported with NM (all chi-square P < .05), which patients preferred over the NM-CS and ONM options (n = 22, 9 and 4 respectively, P = .001). The CPAP adherence did not differ between the three different mask interfaces but the residual AHI was lower with NM than ONM and patients reported greater mask comfort, better sleep, and overall preference for a NM. A nasal mask with or without chinstrap should be the first choice for patients with OSA referred for CPAP treatment. Registry: Australian and New Zealand Clinical Trials Registry, URL: https://www.anzctr.org.au, title: A comparison of continuous positive airway pressure (CPAP) interface in the control of leak, patient compliance and patient preference: nasal CPAP mask and chinstrap versus full face mask in patients with obstructive sleep apnoea (OSA), identifier: ACTRN12609000029291. © 2018 American Academy of Sleep Medicine

From online randomized controlled trials to participant preference studies: morphing the San Francisco Stop Smoking site into a worldwide smoking cessation resource.

PubMed

Muñoz, Ricardo F; Aguilera, Adrian; Schueller, Stephen M; Leykin, Yan; Pérez-Stable, Eliseo J

2012-06-27

Internet interventions have the potential to address many of the health problems that produce the greatest global burden of disease. We present a study illustrating this potential. The Spanish/English San Francisco Stop Smoking Internet site, which yielded quit rates of 20% or more at 12 months in published randomized controlled trials (RCTs), was modified to make it accessible to Spanish- and English-speaking smokers 18 years of age or older anywhere in the world. To illustrate that Internet interventions designed to conduct RCTs can be adapted to serve as universal health care resources. We also examine quit rates obtained in the current participant preference study (in which users could choose from all elements tested in previous RCTs) to determine whether they differ from the quit rates found in the RCTs. We modified the San Francisco Stop Smoking Internet site so that, instead of being randomly assigned to a specific intervention, participants could personalize the site by choosing among nine site elements (eg, stop smoking guide, reminder emails, journal, mood management intervention, or virtual group). Participants completed a baseline assessment, and reported smoking and mood data at 1-, 3-, 6-, and 12-month follow-ups. We assessed the modified website's reach and outcomes (quit rates), and compared the quit rates of the current participant preference study with those of the previous RCTs. In the first year of recruitment, 94,158 individuals from 152 countries and territories visited the site; 13,488 participants left some data; 9173 signed consent; 7763 completed the baseline survey; and 1955, 1362, 1106, and 1096 left 1-, 3-, 6-, and 12-month data, respectively. Observed quit rates were 38.1% (n = 668), 44.9% (n = 546), 43.6% (n = 431), and 45.4% (n = 449), respectively. The current participant preference study yielded higher observed quit rates (odds ratio 1.30) than the previous RCT when controlling for individuals' demographic and smoking characteristics. After strict RCTs are completed, Internet intervention sites can be made into worldwide health intervention resources without reducing their effectiveness. Clinicaltrials.gov NCT00721786; http://clinicaltrials.gov/ct2/show/NCT00721786 (Archived by WebCite at http://www.webcitation.org/66npiZF4y).

Comparison of Antibiotic Therapy and Appendectomy for Acute Uncomplicated Appendicitis in Children: A Meta-analysis.

PubMed

Huang, Libin; Yin, Yuan; Yang, Lie; Wang, Cun; Li, Yuan; Zhou, Zongguang

2017-05-01

Antibiotic therapy for acute uncomplicated appendicitis is effective in adult patients, but its application in pediatric patients remains controversial. To compare the safety and efficacy of antibiotic treatment vs appendectomy as the primary therapy for acute uncomplicated appendicitis in pediatric patients. The PubMed, MEDLINE, EMBASE, and Cochrane Library databases and the Cochrane Controlled Trials Register for randomized clinical trials were searched through April 17, 2016. The search was limited to studies published in English. Search terms included appendicitis, antibiotics, appendectomy, randomized controlled trial, controlled clinical trial, randomized, placebo, drug therapy, randomly, and trial. Randomized clinical trials and prospective clinical controlled trials comparing antibiotic therapy with appendectomy for acute uncomplicated appendicitis in pediatric patients (aged 5-18 years) were included in the meta-analysis. The outcomes included at least 2 of the following terms: success rate of antibiotic treatment and appendectomy, complications, readmissions, length of stay, total cost, and disability days. Data were independently extracted by 2 reviewers. The quality of the included studies was examined in accordance with the Cochrane guidelines and the Newcastle-Ottawa criteria. Data were pooled using a logistic fixed-effects model, and the subgroup pooled risk ratio with or without appendicolith was estimated. The primary outcome was the success rate of treatment. The hypothesis was formulated before data collection. A total of 527 articles were screened. In 5 unique studies, 404 unique patients with uncomplicated appendicitis (aged 5-15 years) were enrolled. Nonoperative treatment was successful in 152 of 168 patients (90.5%), with a Mantel-Haenszel fixed-effects risk ratio of 8.92 (95% CI, 2.67-29.79; heterogeneity, P = .99; I2 = 0%). Subgroup analysis showed that the risk for treatment failure in patients with appendicolith increased, with a Mantel-Haenszel fixed-effects risk ratio of 10.43 (95% CI, 1.46-74.26; heterogeneity, P = .91; I2 = 0%). This meta-analysis shows that antibiotics as the initial treatment for pediatric patients with uncomplicated appendicitis may be feasible and effective without increasing the risk for complications. However, the failure rate, mainly caused by the presence of appendicolith, is higher than for appendectomy. Surgery is preferably suggested for uncomplicated appendicitis with appendicolith.

Comparison of Antibiotic Therapy and Appendectomy for Acute Uncomplicated Appendicitis in Children

PubMed Central

Huang, Libin; Yin, Yuan; Yang, Lie; Wang, Cun; Zhou, Zongguang

2017-01-01

Importance Antibiotic therapy for acute uncomplicated appendicitis is effective in adult patients, but its application in pediatric patients remains controversial. Objective To compare the safety and efficacy of antibiotic treatment vs appendectomy as the primary therapy for acute uncomplicated appendicitis in pediatric patients. Data Sources The PubMed, MEDLINE, EMBASE, and Cochrane Library databases and the Cochrane Controlled Trials Register for randomized clinical trials were searched through April 17, 2016. The search was limited to studies published in English. Search terms included appendicitis, antibiotics, appendectomy, randomized controlled trial, controlled clinical trial, randomized, placebo, drug therapy, randomly, and trial. Study Selection Randomized clinical trials and prospective clinical controlled trials comparing antibiotic therapy with appendectomy for acute uncomplicated appendicitis in pediatric patients (aged 5-18 years) were included in the meta-analysis. The outcomes included at least 2 of the following terms: success rate of antibiotic treatment and appendectomy, complications, readmissions, length of stay, total cost, and disability days. Data Extraction and Synthesis Data were independently extracted by 2 reviewers. The quality of the included studies was examined in accordance with the Cochrane guidelines and the Newcastle-Ottawa criteria. Data were pooled using a logistic fixed-effects model, and the subgroup pooled risk ratio with or without appendicolith was estimated. Main Outcomes and Measures The primary outcome was the success rate of treatment. The hypothesis was formulated before data collection. Results A total of 527 articles were screened. In 5 unique studies, 404 unique patients with uncomplicated appendicitis (aged 5-15 years) were enrolled. Nonoperative treatment was successful in 152 of 168 patients (90.5%), with a Mantel-Haenszel fixed-effects risk ratio of 8.92 (95% CI, 2.67-29.79; heterogeneity, P = .99; I2 = 0%). Subgroup analysis showed that the risk for treatment failure in patients with appendicolith increased, with a Mantel-Haenszel fixed-effects risk ratio of 10.43 (95% CI, 1.46-74.26; heterogeneity, P = .91; I2 = 0%). Conclusions and Relevance This meta-analysis shows that antibiotics as the initial treatment for pediatric patients with uncomplicated appendicitis may be feasible and effective without increasing the risk for complications. However, the failure rate, mainly caused by the presence of appendicolith, is higher than for appendectomy. Surgery is preferably suggested for uncomplicated appendicitis with appendicolith. PMID:28346589

Polyethylene glycol 3350 in occasional constipation: A one-week, randomized, placebo-controlled, double-blind trial

PubMed Central

McGraw, Thomas

2016-01-01

AIM: To evaluate the efficacy and safety of polyethylene glycol (PEG) 3350 in subjects with self-reported occasional constipation. METHODS: Eligible subjects ≥ 17 years of age were randomized to receive either placebo or PEG 3350 17 g once daily in this multicenter, double-blind trial. Evaluations were conducted before (baseline) and after a 7-d treatment period. The primary efficacy variable was the proportion of subjects reporting complete resolution of straining and hard or lumpy stools. Secondary efficacy variables assessed the severity of the subjects’ daily bowel movement (BM) symptoms, and preference of laxatives based on diary entries, visual analog scale scores, and questionnaires. RESULTS: Of the 203 subjects enrolled in the study, 11 had major protocol violations. Complete resolution was noted by 36/98 (36.7%) subjects in the PEG 3350 group and 23/94 (24.5%) in the placebo group (P = 0.0595). The number of complete BMs without straining or lumpy stools was similar between both groups. Subjects receiving PEG 3350 experienced significant relief in straining and reduction in hardness of stools over a 7-d period (P < 0.0001). Subjects reported that PEG 3350 had a better effect on their daily lives, provided better control over a BM, better relief from constipation, cramping, and bloating, and was their preferred laxative. Adverse events (AEs) were balanced between the PEG 3350 and the placebo groups. No deaths, serious AEs, or discontinuations due to AEs were reported. This trial is registered at clinicaltrials.gov as NCT00770432. CONCLUSION: Oral administration of 17 g PEG 3350 once daily for a week is effective, safe, and well tolerated in subjects with occasional constipation. PMID:27158544

Oral anticoagulant re-initiation following intracerebral hemorrhage in non-valvular atrial fibrillation: Global survey of the practices of neurologists, neurosurgeons and thrombosis experts.

PubMed

Xu, Yan; Shoamanesh, Ashkan; Schulman, Sam; Dowlatshahi, Dar; Al-Shahi Salman, Rustam; Moldovan, Ioana Doina; Wells, Philip Stephen; AlKherayf, Fahad

2018-01-01

While oral anticoagulants (OACs) are highly effective for ischemic stroke prevention in atrial fibrillation, intracerebral hemorrhage (ICH) remains the most feared complication of OAC. Clinical controversy remains regarding OAC resumption and its timing for ICH survivors with atrial fibrillation because the balance between risks and benefits has not been investigated in randomized trials. To survey the practice of stroke neurologists, thrombosis experts and neurosurgeons on OAC re-initiation following OAC-associated ICH. An online survey was distributed to members of the International Society for Thrombosis and Haemostasis, Canadian Stroke Consortium, NAVIGATE-ESUS trial investigators (Clinicatrials.gov identifier NCT02313909) and American Association of Neurological Surgeons. Demographic factors and 11 clinical scenarios were included. Two hundred twenty-eight participants from 38 countries completed the survey. Majority of participants were affiliated with academic centers, and >20% managed more than 15 OAC-associated ICH patients/year. Proportion of respondents suggesting OAC anticoagulant resumption varied from 30% (for cerebral amyloid angiopathy) to 98% (for traumatic ICH). Within this group, there was wide distribution in response for timing of resumption: 21.4% preferred to re-start OACs after 1-3 weeks of incident ICH, while 25.3% opted to start after 1-3 months. Neurosurgery respondents preferred earlier OAC resumption compared to stroke neurologists or thrombosis experts in 5 scenarios (p<0.05 by Kendall's tau). Wide variations in current practice exist among management of OAC-associated ICH, with decisions influenced by patient- and provider-related factors. As these variations likely reflect the lack of high quality evidence, randomized trials are direly needed in this population.

Recommendation for axillary lymph node dissection in women with early breast cancer and sentinel node metastasis: A systematic review and meta-analysis of randomized controlled trials using the GRADE system.

PubMed

Huang, Tsai-Wei; Kuo, Ken N; Chen, Kee-Hsin; Chen, Chiehfeng; Hou, Wen-Hsuan; Lee, Wei-Hwa; Chao, Tsu-Yi; Tsai, Jo-Ting; Su, Chih-Ming; Huang, Ming-Te; Tam, Ka-Wai

2016-10-01

In 2014, the American Society of Clinical Oncology published an updated clinical practice guideline on axillary lymph node dissection (ALND) for early-stage breast cancer patients. However, these recommendations have been challenged because they were based on data from only one randomized controlled trial (RCT). We evaluated the rationale of these recommendations by systematically reviewing RCTs using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) system. We searched articles in the PubMed, EMBASE, CINAHL, Scopus, and Cochrane databases. The primary endpoints were overall survival (OS) and disease-free survival (DFS). The secondary endpoints were recurrence rate and surgical complications of axillary dissection. The quality of evidence was assessed using the GRADE profiler. Five eligible studies were retrieved and analyzed. We divided sentinel lymph node (SLN) metastasis into two categories: SLN micrometastasis and SLN macrometastasis. In patients with 1 or 2 SLN micrometastasis, no significant difference was observed in OS, DFS, or recurrence rate between the ALND and non-ALND groups. For patients with 1 or 2 SLN marcometastasis, only one trial with a moderate risk of bias was included, and non-ALND was the preferred management overall. However, ALND might be appropriate for patients who placed a greater emphasis on longer-term survival at any cost. We recommend non-ALND management for early breast cancer patients with 1 or 2 SLN micrometastasis or macrometastasis on the basis of a systematic review of the current evidence conducted using the GRADE system. However, the optimal practice of evidence-based medicine should incorporate patient preferences, particularly when evidence is limited. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Polyethylene glycol 3350 in occasional constipation: A one-week, randomized, placebo-controlled, double-blind trial.

PubMed

McGraw, Thomas

2016-05-06

To evaluate the efficacy and safety of polyethylene glycol (PEG) 3350 in subjects with self-reported occasional constipation. Eligible subjects ≥ 17 years of age were randomized to receive either placebo or PEG 3350 17 g once daily in this multicenter, double-blind trial. Evaluations were conducted before (baseline) and after a 7-d treatment period. The primary efficacy variable was the proportion of subjects reporting complete resolution of straining and hard or lumpy stools. Secondary efficacy variables assessed the severity of the subjects' daily bowel movement (BM) symptoms, and preference of laxatives based on diary entries, visual analog scale scores, and questionnaires. Of the 203 subjects enrolled in the study, 11 had major protocol violations. Complete resolution was noted by 36/98 (36.7%) subjects in the PEG 3350 group and 23/94 (24.5%) in the placebo group (P = 0.0595). The number of complete BMs without straining or lumpy stools was similar between both groups. Subjects receiving PEG 3350 experienced significant relief in straining and reduction in hardness of stools over a 7-d period (P < 0.0001). Subjects reported that PEG 3350 had a better effect on their daily lives, provided better control over a BM, better relief from constipation, cramping, and bloating, and was their preferred laxative. Adverse events (AEs) were balanced between the PEG 3350 and the placebo groups. No deaths, serious AEs, or discontinuations due to AEs were reported. This trial is registered at clinicaltrials.gov as NCT00770432. Oral administration of 17 g PEG 3350 once daily for a week is effective, safe, and well tolerated in subjects with occasional constipation.

Who's really hypertensive?--Quality control issues in the assessment of blood pressure for randomized trials.

PubMed

Reid, Christopher M; Ryan, Philip; Miles, Helen; Willson, Kristyn; Beilin, Laurence J; Brown, Mark A; Jennings, Garry L; Johnston, Colin I; Macdonald, Graham J; Marley, John E; McNeil, John J; Morgan, Trefor O; West, Malcolm J; Wing, Lindon M H

2005-01-01

The characterization of blood pressure in treatment trials assessing the benefits of blood pressure lowering regimens is a critical factor for the appropriate interpretation of study results. With numerous operators involved in the measurement of blood pressure in many thousands of patients being screened for entry into clinical trials, it is essential that operators follow pre-defined measurement protocols involving multiple measurements and standardized techniques. Blood pressure measurement protocols have been developed by international societies and emphasize the importance of appropriate choice of cuff size, identification of Korotkoff sounds, and digit preference. Training of operators and auditing of blood pressure measurement may assist in reducing the operator-related errors in measurement. This paper describes the quality control activities adopted for the screening stage of the 2nd Australian National Blood Pressure Study (ANBP2). ANBP2 is cardiovascular outcome trial of the treatment of hypertension in the elderly that was conducted entirely in general practices in Australia. A total of 54 288 subjects were screened; 3688 previously untreated subjects were identified as having blood pressure >140/90 mmHg at the initial screening visit, 898 (24%) were not eligible for study entry after two further visits due to the elevated reading not being sustained. For both systolic and diastolic blood pressure recording, observed digit preference fell within 7 percentage points of the expected frequency. Protocol adherence, in terms of the required minimum blood pressure difference between the last two successive recordings, was 99.8%. These data suggest that adherence to blood pressure recording protocols and elimination of digit preferences can be achieved through appropriate training programs and quality control activities in large multi-centre community-based trials in general practice. Repeated blood pressure measurement prior to initial diagnosis and study entry is essential to appropriately characterize hypertension in these elderly patients.

Seeing the forest through the trees: improving decision making on the Iowa gambling task by shifting focus from short- to long-term outcomes

PubMed Central

Buelow, Melissa T.; Okdie, Bradley M.; Blaine, Amber L.

2013-01-01

Introduction: The present study sought to examine two methods by which to improve decision making on the Iowa Gambling Task (IGT): inducing a negative mood and providing additional learning trials. Method: In the first study, 194 undergraduate students [74 male; Mage = 19.44 (SD = 3.69)] were randomly assigned to view a series of pictures to induce a positive, negative, or neutral mood immediately prior to the IGT. In the second study, 276 undergraduate students [111 male; Mage = 19.18 (SD = 2.58)] completed a delay discounting task and back-to-back administrations of the IGT. Results: Participants in an induced negative mood selected more from Deck C during the final trials than those in an induced positive mood. Providing additional learning trials resulted in better decision making: participants shifted their focus from the frequency of immediate gains/losses (i.e., a preference for Decks B and D) to long-term outcomes (i.e., a preference for Deck D). In addition, disadvantageous decision making on the additional learning trials was associated with larger delay discounting (i.e., a preference for more immediate but smaller rewards). Conclusions: The present results indicate that decision making is affected by negative mood state, and that decision making can be improved by increasing the number of learning trials. In addition, the current results provide evidence of a relationship between performance on the IGT and on a separate measure of decision making, the delay discounting task. Moreover, the present results indicate that improved decision making on the IGT can be attributed to shifting focus toward long-term outcomes, as evidenced by increased selections from advantageous decks as well as correlations between the IGT and delay discounting task. Implications for the assessment of decision making using the IGT are discussed. PMID:24151485

The effects of community income inequality on health: Evidence from a randomized control trial in the Bolivian Amazon.

PubMed

Undurraga, Eduardo A; Behrman, Jere R; Leonard, William R; Godoy, Ricardo A

2016-01-01

Research suggests that poorer people have worse health than the better-off and, more controversially, that income inequality harms health. But causal interpretations suffer from endogeneity. We addressed the gap by using a randomized control trial among a society of forager-farmers in the Bolivian Amazon. Treatments included one-time unconditional income transfers (T1) to all households and (T2) only to the poorest 20% of households, with other villages as controls. We assessed the effects of income inequality, absolute income, and spillovers within villages on self-reported health, objective indicators of health and nutrition, and adults' substance consumption. Most effects came from relative income. Targeted transfers increased the perceived stress of participants in better-off households. Evidence suggests increased work efforts among better-off households when the lot of the poor improved, possibly due to a preference for rank preservation. The study points to new paths by which inequality might affect health. Copyright © 2015 Elsevier Ltd. All rights reserved.

The effects of community income inequality on health: Evidence from a randomized control trial in the Bolivian Amazon

PubMed Central

Undurraga, Eduardo A.; Behrman, Jere R.; Leonard, William R.; Godoy, Ricardo A.

2015-01-01

Research suggests that poorer people have worse health than the better-off and, more controversially, that income inequality harms health. But causal interpretations suffer from endogeneity. We addressed the gap by using a randomized control trial among a society of forager-farmers in the Bolivian Amazon. Treatments included one-time unconditional income transfers (T1) to all households and (T2) only to the poorest 20% of households, with other villages as controls. We assessed the effects of income inequality, absolute income, and spillovers within villages on self-reported health, objective indicators of health and nutrition, and adults’ substance consumption. Most effects came from relative income. Targeted transfers increased the perceived stress of participants in better-off households. Evidence suggests increased work efforts among better-off households when the lot of the poor improved, possibly due to a preference for rank preservation. The study points to new paths by which inequality might affect health. PMID:26706403

Rib fractures in trauma patients: does operative fixation improve outcome?

PubMed

Majak, Peter; Næss, Pål A

2016-12-01

Renewed interest in surgical fixation of rib fractures has emerged. However, conservative treatment is still preferred at most surgical departments. We wanted to evaluate whether operative treatment of rib fractures may benefit severely injured patients. Several studies report a reduction in mechanical ventilation time, ICU length of stay (LOS), hospital LOS, pneumonia, need for tracheostomy, pain and costs in operatively treated patients with multiple rib fractures compared with patients treated nonoperatively. Although patient selection and timing of the operation seem crucial for successful outcome, no consensus exists. Mortality reduction has only been shown in a few studies. Most studies are retrospective cohort and case-control studies. Only four randomized control trials exist. Conservative treatment, consisting of respiratory assistance and pain control, is still the treatment of choice in the vast majority of patients with multiple rib fractures. In selected patients, operative fixation of fractured ribs within 72 h postinjury may lead to better outcome. More randomized control trials are needed to further determine who benefits from surgical fixation of rib fractures.

Randomized controlled trial on postoperative pulmonary humidification after total laryngectomy: external humidifier versus heat and moisture exchanger.

PubMed

Mérol, Jean-Claude; Charpiot, Anne; Langagne, Thibault; Hémar, Patrick; Ackerstaff, Annemieke H; Hilgers, Frans J M

2012-02-01

Assessment of immediate postoperative airway humidification after total laryngectomy (TLE), comparing the use of an external humidifier (EH) with humidification through a heat and moisture exchanger (HME). Randomized controlled trial (RCT). Fifty-three patients were randomized into the standard (control) EH (N = 26) or the experimental HME arm (N = 27). Compliance, pulmonary and sleeping problems, patients' and nursing staff satisfaction, nursing time, and cost-effectiveness were assessed with trial-specific structured questionnaires and tally sheets. In the EH arm data were available for all patients, whereas in the HME arm data were incomplete for four patients. The 24/7 compliance rate in the EH arm was 12% and in the HME arm 87% (77% if the four nonevaluable patients are considered noncompliant). Compliance and patients' satisfaction were significantly better, and the number of coughing episodes, mucus expectoration for clearing the trachea, and sleeping disturbances were significantly less in the HME arm (P < .001). This was also the case for nursing time and nursing staff satisfaction and preference. This RCT clearly shows the benefits of immediate postoperative airway humidification by means of an HME over the use of an EH after TLE. This study therefore underlines that HMEs presently can be considered the better option for early postoperative airway humidification after TLE. Copyright © 2011 The American Laryngological, Rhinological, and Otological Society, Inc.

Quantitative benefit-harm assessment for setting research priorities: the example of roflumilast for patients with COPD.

PubMed

Puhan, Milo A; Yu, Tsung; Boyd, Cynthia M; Ter Riet, Gerben

2015-07-02

When faced with uncertainties about the effects of medical interventions regulatory agencies, guideline developers, clinicians, and researchers commonly ask for more research, and in particular for more randomized trials. The conduct of additional randomized trials is, however, sometimes not the most efficient way to reduce uncertainty. Instead, approaches such as value of information analysis or other approaches should be used to prioritize research that will most likely reduce uncertainty and inform decisions. In situations where additional research for specific interventions needs to be prioritized, we propose the use of quantitative benefit-harm assessments that illustrate how the benefit-harm balance may change as a consequence of additional research. The example of roflumilast for patients with chronic obstructive pulmonary disease shows that additional research on patient preferences (e.g., how important are exacerbations relative to psychiatric harms?) or outcome risks (e.g., what is the incidence of psychiatric outcomes in patients with chronic obstructive pulmonary disease without treatment?) is sometimes more valuable than additional randomized trials. We propose that quantitative benefit-harm assessments have the potential to explore the impact of additional research and to identify research priorities Our approach may be seen as another type of value of information analysis and as a useful approach to stimulate specific new research that has the potential to change current estimates of the benefit-harm balance and decision making.

Evaluation of the efficacy of Withania somnifera (Ashwagandha) root extract in patients with obsessive-compulsive disorder: A randomized double-blind placebo-controlled trial.

PubMed

Jahanbakhsh, Seyedeh Pardis; Manteghi, Ali Akhondpour; Emami, Seyed Ahmad; Mahyari, Saman; Gholampour, Beheshteh; Mohammadpour, Amir Hooshang; Sahebkar, Amirhossein

2016-08-01

Obsessive-compulsive disorder (OCD) is a chronic psychiatric disorder that is causally linked to dysregulation of the serotonergic system. The aim of this study is to investigate the efficacy of Withania somnifera (W. somnifera) root extract as an adjunct therapy to standard OCD treatment. Thirty patients with a confirmed diagnosis of OCD according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria participated in this randomized double-blind placebo-controlled trial and were randomly assigned to the treatment group (W. somnifera extract, 120mg/day; n=15) or the placebo group (n=15). All patients were under treatment with Selective Serotonin Re-uptake Inhibitors (SSRIs), and were instructed to take 4 capsules of the extract or placebo per day, preferably after meals, for a period of six weeks. The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) was used in order to assess the severity of OCD symptoms at baseline and at the end of the trial. Statistical analyses were performed using SPSS software and Y-BOCS values were presented as median and range (Min-Max). Comparison of the change in Y-BOCS score during the course of the trial revealed a significantly greater effect of W. somnifera (26 (14-40) [pre-treatment] versus 14 (4-40) [post-treatment]; change: -8 (-23 to 0)) versus placebo (18 (11-33) [pre-treatment] versus 16 (10-31) [post-treatment]; change: -2 (-4 to 0)) (P<0.001). The extract was safe and no adverse event was reported during the trial. W. somnifera extract may be beneficial as a safe and effective adjunct to SSRIs in the treatment of OCD. Copyright © 2016. Published by Elsevier Ltd.

Physical activity as an aid to smoking cessation during pregnancy (LEAP) trial: study protocol for a randomized controlled trial.

PubMed

Ussher, Michael; Aveyard, Paul; Manyonda, Isaac; Lewis, Sarah; West, Robert; Lewis, Beth; Marcus, Bess; Taylor, Adrian H; Barton, Pelham; Coleman, Tim

2012-10-04

Many women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA) interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP) trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date. The LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy), and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation) or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations). The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome. This trial will assess whether a PA intervention is effective when used for smoking cessation during pregnancy. ISRCTN48600346.

Inclusion and definition of acute renal dysfunction in critically ill patients in randomized controlled trials: a systematic review.

PubMed

da Hora Passos, Rogerio; Ramos, Joao Gabriel Rosa; Gobatto, André; Caldas, Juliana; Macedo, Etienne; Batista, Paulo Benigno

2018-04-24

In evidence-based medicine, multicenter, prospective, randomized controlled trials (RCTs) are the gold standard for evaluating treatment benefits and ensuring the effectiveness of interventions. Patient-centered outcomes, such as mortality, are most often the preferred evaluated outcomes. While there is currently agreement on how to classify renal dysfunction in critically ill patients , the application frequency of this new classification system in RCTs has not previously been evaluated. In this study, we aim to assess the definition of renal dysfunction in multicenter RCTs involving critically ill patients that included mortality as a primary endpoint. A comprehensive search was conducted for publications reporting multicenter randomized controlled trials (RCTs) involving adult patients in intensive care units (ICUs) that included mortality as a primary outcome. MEDLINE and PUBMED were queried for relevant articles in core clinical journals published between May 2004 and December 2017. Of 418 articles reviewed, 46 multicenter RCTs with a primary endpoint related to mortality were included. Thirty-six (78.3%) of the trial reports provided information on renal function in the participants. Only seven articles (15.2%) included mean or median serum creatinine levels, mean creatinine clearance or estimated glomerular filtration rates. Sequential organ failure assessment (SOFA) score was the most commonly used definition of renal dysfunction (20 studies; 43.5%). Risk, Injury, Failure, Loss, End-stage renal disease (RIFLE), Acute Kidney Injury Network (AKIN) and Kidney Disease Improving Global Outcomes (KDIGO) criteria were used in five (10.9%) trials. In thirteen trials (28.3%), no renal dysfunction criteria were reported. Only one trial excluded patients with renal dysfunction, and it used urinary output or need for renal replacement therapy (RRT) as criteria for this diagnosis. The presence of renal dysfunction was included as a baseline patient characteristic in most RCTs. The RIFLE, AKIN and KDIGO classification systems were infrequently used; renal dysfunction was generally defined using the SOFA score.

Web App- and Text Message-Based Patient Education in Mohs Micrographic Surgery-A Randomized Controlled Trial.

PubMed

Hawkins, Spencer D; Koch, Sarah B; Williford, Phillip M; Feldman, Steven R; Pearce, Daniel J

2018-07-01

Consent and wound care (WC) videos are used for education in Mohs micrographic surgery (MMS). Postoperative text messaging is poorly studied. Develop and evaluate perioperative resources for MMS patients-video modules (DermPatientEd.com) and postoperative text messaging (DermTexts.com). A study was conducted on 90 MMS patients. Patients were randomized 1:1:1:1 to videos with text messages, videos-only, text messages-only, or control. Primary outcomes included preoperative anxiety and knowledge of MMS and postoperative care. The secondary outcome included helpfulness/preference of interventions. Patients experienced a 19% reduction in anxiety as measured by a visual analog scale after the MMS video (p = .00062). There was no difference in knowledge after the WC video (p = .21498). Patients were more likely to report the WC video "very helpful" when compared with the pamphlet in understanding postoperative WC (p = .0016). Patients in text messaging groups were not more likely to report the service as "very helpful" when compared with the pamphlet (p = .3566), but preferred to receive WC instructions by text message for future visits (p = .0001). These resources proved helpful and effective in reducing preoperative anxiety. Patients prefer text message-based WC instructions over pamphlets after experiencing the service, but do not find them more helpful.

A Systematic Review of NMDA Receptor Antagonists for Treatment of Neuropathic Pain in Clinical Practice.

PubMed

Aiyer, Rohit; Mehta, Neel; Gungor, Semih; Gulati, Amitabh

2018-05-01

To investigate the efficacy of N-methyl-D-aspartate receptor (NMDAR) antagonists for neuropathic pain (NeuP) and review literature to determine if specific pharmacologic agents provide adequate NeuP relief. Literature was reviewed on PubMed using a variety of key words for 8 NMDAR antagonists. These key words include: "Ketamine and Neuropathy," "Ketamine and Neuropathic Pain," "Methadone and Neuropathy," "Methadone and Neuropathic Pain," "Memantine and Neuropathic pain," "Memantine and Neuropathy," "Amantadine and Neuropathic Pain," "Amantadine and Neuropathy," "Dextromethorphan and Neuropathic Pain," "Dextromethorphan and Neuropathy," "Carbamazepine and Neuropathic Pain," "Carbamazepine and Neuropathy," "Valproic Acid and Neuropathy," "Valproic Acid and Neuropathic Pain," "Phenytoin and Neuropathy," and "Phenytoin and Neuropathic Pain." With the results, the papers were reviewed using the PRISMA (Preferred Reporting in Systematic and Meta-Analyses) guideline. A total of 58 randomized controlled trials were reviewed among 8 pharmacologic agents, which are organized by date and alphabetical order. Of the trials for ketamine, 15 showed some benefit for analgesia. Methadone had 3 positive trials, while amantadine and memantine each only had 2 trials showing NeuP analgesic properties. Dextromethorphan and valproic acid both had 4 randomized controlled trials that showed some NeuP treatment benefit while carbamazepine had over 8 trials showing efficacy. Finally, phenytoin only had 1 trial that showed clinical response in treatment. There are a variety of NMDAR antagonist agents that should be considered for treatment of NeuP. Nevertheless, continued and further investigation of the 8 pharmacologic agents is needed to continue to evaluate their efficacy for treatment of NeuP.

Patient-centered outcomes comparing digital and conventional implant impression procedures: a randomized crossover trial.

PubMed

Joda, Tim; Brägger, Urs

2016-12-01

The aim of this randomized controlled trial was to compare patient-centered outcomes during digital and conventional implant impressions. In a crossover study design, intraoral scanning (IOS) [test] as well as classical polyether impressions [control] were both performed on 20 patients for single-tooth replacement with implant-supported crowns. The sequential distribution of either starting with the test or the control procedure was randomly selected. Patients' perception and satisfaction on the level of convenience-related factors were assessed with visual analogue scale (VAS) questionnaires. In addition, clinical work time was separately recorded for test and control procedures. Statistical analyses were performed with Wilcoxon signed-rank tests and corrected for multiple testing by the method of Holm. On VAS ranging from 0 to 100, patients scored a mean convenience level of 78.6 (SD ± 14.0) in favor of IOS compared to conventional impressions with 53.6 (SD ± 15.4) [P = 0.0001]. All included patients would prefer the digital workflow if in the future they could choose between the two techniques. Secondary, IOS was significantly faster with 14.8 min (SD ± 2.2) compared to the conventional approach with 17.9 min (SD ± 1.1) [P = 0.0001]. Based on the findings of this investigation, both impression protocols worked successfully for all study participants capturing the 3D implant positions. However, the digital technique emerges as the most preferred one according to patient-centered outcomes and was more time-effective compared to conventional impressions. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Use of Bayesian Decision Analysis to Minimize Harm in Patient-Centered Randomized Clinical Trials in Oncology.

PubMed

Montazerhodjat, Vahid; Chaudhuri, Shomesh E; Sargent, Daniel J; Lo, Andrew W

2017-09-14

Randomized clinical trials (RCTs) currently apply the same statistical threshold of alpha = 2.5% for controlling for false-positive results or type 1 error, regardless of the burden of disease or patient preferences. Is there an objective and systematic framework for designing RCTs that incorporates these considerations on a case-by-case basis? To apply Bayesian decision analysis (BDA) to cancer therapeutics to choose an alpha and sample size that minimize the potential harm to current and future patients under both null and alternative hypotheses. We used the National Cancer Institute (NCI) Surveillance, Epidemiology, and End Results (SEER) database and data from the 10 clinical trials of the Alliance for Clinical Trials in Oncology. The NCI SEER database was used because it is the most comprehensive cancer database in the United States. The Alliance trial data was used owing to the quality and breadth of data, and because of the expertise in these trials of one of us (D.J.S.). The NCI SEER and Alliance data have already been thoroughly vetted. Computations were replicated independently by 2 coauthors and reviewed by all coauthors. Our prior hypothesis was that an alpha of 2.5% would not minimize the overall expected harm to current and future patients for the most deadly cancers, and that a less conservative alpha may be necessary. Our primary study outcomes involve measuring the potential harm to patients under both null and alternative hypotheses using NCI and Alliance data, and then computing BDA-optimal type 1 error rates and sample sizes for oncology RCTs. We computed BDA-optimal parameters for the 23 most common cancer sites using NCI data, and for the 10 Alliance clinical trials. For RCTs involving therapies for cancers with short survival times, no existing treatments, and low prevalence, the BDA-optimal type 1 error rates were much higher than the traditional 2.5%. For cancers with longer survival times, existing treatments, and high prevalence, the corresponding BDA-optimal error rates were much lower, in some cases even lower than 2.5%. Bayesian decision analysis is a systematic, objective, transparent, and repeatable process for deciding the outcomes of RCTs that explicitly incorporates burden of disease and patient preferences.

Use of Bayesian Decision Analysis to Minimize Harm in Patient-Centered Randomized Clinical Trials in Oncology

PubMed Central

Montazerhodjat, Vahid; Chaudhuri, Shomesh E.; Sargent, Daniel J.

2017-01-01

Importance Randomized clinical trials (RCTs) currently apply the same statistical threshold of alpha = 2.5% for controlling for false-positive results or type 1 error, regardless of the burden of disease or patient preferences. Is there an objective and systematic framework for designing RCTs that incorporates these considerations on a case-by-case basis? Objective To apply Bayesian decision analysis (BDA) to cancer therapeutics to choose an alpha and sample size that minimize the potential harm to current and future patients under both null and alternative hypotheses. Data Sources We used the National Cancer Institute (NCI) Surveillance, Epidemiology, and End Results (SEER) database and data from the 10 clinical trials of the Alliance for Clinical Trials in Oncology. Study Selection The NCI SEER database was used because it is the most comprehensive cancer database in the United States. The Alliance trial data was used owing to the quality and breadth of data, and because of the expertise in these trials of one of us (D.J.S.). Data Extraction and Synthesis The NCI SEER and Alliance data have already been thoroughly vetted. Computations were replicated independently by 2 coauthors and reviewed by all coauthors. Main Outcomes and Measures Our prior hypothesis was that an alpha of 2.5% would not minimize the overall expected harm to current and future patients for the most deadly cancers, and that a less conservative alpha may be necessary. Our primary study outcomes involve measuring the potential harm to patients under both null and alternative hypotheses using NCI and Alliance data, and then computing BDA-optimal type 1 error rates and sample sizes for oncology RCTs. Results We computed BDA-optimal parameters for the 23 most common cancer sites using NCI data, and for the 10 Alliance clinical trials. For RCTs involving therapies for cancers with short survival times, no existing treatments, and low prevalence, the BDA-optimal type 1 error rates were much higher than the traditional 2.5%. For cancers with longer survival times, existing treatments, and high prevalence, the corresponding BDA-optimal error rates were much lower, in some cases even lower than 2.5%. Conclusions and Relevance Bayesian decision analysis is a systematic, objective, transparent, and repeatable process for deciding the outcomes of RCTs that explicitly incorporates burden of disease and patient preferences. PMID:28418507

Physicians' choice in using Internet and fax for patient recruitment and follow-up in a randomized controlled trial.

PubMed

Rahman, M; Morita, S; Fukui, T; Sakamoto, J

2004-01-01

To examine the physicians' preference between Web and fax-based remote data entry (RDE) system for an ongoing randomized controlled trial (RCT) in Japan. We conducted a survey among all the collaborating physicians (n = 512) of the CASE-J (Candesartan Antihypertensive Survival Evaluation in Japan) trial, who have been recruiting patients and sending follow-up data using the Web or a fax-based RDE system. The survey instrument assessed physicians' choice between Web and fax-based RDE systems, their practice pattern, and attitudes towards these two modalities. A total of 448 (87.5%) responses were received. The proportions of physicians who used Web, fax, and the combination of these two were 45.9%, 33.3% and 20.8%, respectively. Multivariate logistic regression analyses revealed that physicians 55 years or younger [odds ratio (OR) = 1.9, 95% confidence interval (CI) = 1.1-3.3] and regular users of computers (OR = 4.2, 95% CI = 2.1-8.2) were more likely to use the Web-based RDE system. This information would be useful in designing an RCT with a Web-based RDE system in Japan and abroad.

Randomized controlled trial of asthma risk with paracetamol use in infancy--a feasibility study.

PubMed

Riley, J; Braithwaite, I; Shirtcliffe, P; Caswell-Smith, R; Hunt, A; Bowden, V; Power, S; Stanley, T; Crane, J; Ingham, T; Weatherall, M; Mitchell, E A; Beasley, R

2015-02-01

There is non-experimental evidence that paracetamol (acetaminophen) use may increase the risk of developing asthma. However, numerous methodological issues need to be resolved before undertaking a randomized controlled trial to investigate this hypothesis. To establish the feasibility of a randomized controlled trial of liberal paracetamol as usually given by parents/guardians vs. a comparator (restricted paracetamol in accordance with WHO guidelines, ibuprofen or placebo), and childhood asthma risk. Questionnaires were completed by parents/guardians of infants admitted to Wellington Hospital with bronchiolitis to assess views about comparator treatments. Subsequently, infants of parents/guardians who provided informed consent were randomized to restricted or liberal paracetamol use for 3 months with paracetamol use recorded. Of 120 eligible participants, 72 (60%) parents/guardians completed the questionnaire. Ibuprofen, restricted paracetamol and placebo were acceptable to 42 (58%), 29 (40%) and 9 (12%) parents/guardians, respectively. 36 (30%) infants were randomized to restricted or liberal paracetamol. Paracetamol use was greater for the liberal vs. restricted group for reported [Hodges-Lehmann estimator of difference 0.94 mg/kg/day (95% CI 0.2-3.52), P = 0.02] and measured use [Hodges-Lehmann estimator of difference 2.11 mg/kg/day (95% CI 0.9-4.18), P = 0.004]. The median reported and measured use of paracetamol was 2.0-fold and 3.5-fold greater in the liberal vs. restricted group. Although separation in paracetamol dosing is likely to be achieved with a liberal vs. restricted paracetamol regime, ibuprofen is the preferred comparator treatment in the proposed RCT of paracetamol use and risk of asthma in childhood. © 2014 John Wiley & Sons Ltd.

Randomized, controlled, cross-over clinical trial comparing intravenous midazolam sedation with nitrous oxide sedation in children undergoing dental extractions.

PubMed

Wilson, K E; Girdler, N M; Welbury, R R

2003-12-01

The use of benzodiazepines for paediatric dental sedation has received limited attention with regard to research into clinical effectiveness. A study was therefore designed to investigate the use of midazolam, for i.v. sedation in paediatric dental patients. The aim of the study was to assess the effectiveness of i.v. midazolam in a randomized, controlled, cross-over trial. Children aged 12-16 yr (ASA I and II), requiring two appointments for equivalent but contralateral dental extractions for orthodontic purposes, were recruited. Conscious sedation with either i.v. midazolam titrated at 0.5 mg x min(-1), to a maximum of 5 mg, or nitrous oxide/oxygen titrated to 30%/70% inhalation sedation was used at the first visit, the alternative being used at the second visit. Vital signs including blood pressure, arterial oxygen saturation and ventilatory frequency, as well as sedation levels and behavioural scores, were recorded every 2 min. Forty patients, mean age 13.2 yr (range 12-16 yr), participated in the trial. A mean dose of midazolam 2.8 mg was administered in the test group. The median time to the maximum level of sedation was 8 min for midazolam compared with 6 min for nitrous oxide (P<0.001). Vital signs for both treatments were comparable and within acceptable clinical limits and communication with the patient was maintained at all times. The median (range) lowest arterial oxygen saturation level recorded for midazolam was 97 (91-99)% compared with 97 (92-100)% for nitrous oxide. The mean (range) recovery time for midazolam was 51.6 (39-65) min and 23.3 (20-34) min for nitrous oxide (P<0.0001). Fifty-one per cent said they preferred i.v. midazolam, 38% preferred nitrous oxide, and 11% had no preference. I.V. midazolam sedation (0.5 mg x min(-1) to a maximum of 5 mg) appears to be as effective as nitrous oxide sedation in 12-16-yr-old healthy paediatric dental patients.

A Randomized Controlled Trial Comparing the Letter Project Advance Directive to Traditional Advance Directive.

PubMed

Periyakoil, Vyjeyanthi S; Neri, Eric; Kraemer, Helena

2017-09-01

Simpler alternatives to traditional advance directives that are easy to understand and available in multiple formats and can be initiated by patients and families will help facilitate advance care planning. The goal of this study was to compare the acceptability of the letter advance directive (LAD) to the traditional advance directive (TAD) of the state of California. A web-based, randomized controlled trial was conducted, in which the participants were randomized to one of two types of advance directives (ADs): the LAD (intervention) or the TAD (control). Primary outcomes were participant ratings of the ease, value, and their level of comfort in the AD document they completed. A total of 400 participants completed the study, with 216 randomized to the LAD and 184 to the TAD by a computerized algorithm. Overall, participants preferred the LAD to the TAD (success rate difference [SRD] = 0.46, 95th percentile confidence interval [CI]: 0.36-0.56, p < 0.001). The participants felt that, compared to the TAD, the LAD was easier to read and understand (SRD = 0.56, CI: 0.47-0.65, p < 0.001); better reflected what matters most to them (SRD = 0.39, CI: 0.29-0.48, p < 0.001); helped stimulate their thinking about the types of treatments they wanted at the end of life (SRD = 0.32, CI: 0.23-0.42, p < 0.001); allowed them to describe how they made medical decisions in their family (SRD = 0.31, CI: 0.21-0.40, p < 0.001); and could help their doctor(s) (SRD = 0.24, CI: 0.13-0.34, p < 0.001) and their families (SRD = 0.19, CI: 0.08-0.28, p < 0.001) understand their end-of-life treatment preferences. Patients reported the letter advance directive to be a better alternative to the traditional advance directive form.

[Effect of food television advertising on the preference and food consumption: systematic review].

PubMed

Díaz Ramírez, G; Souto-Gallardo, M C; Bacardí Gascón, M; Jiménez-Cruz, A

2011-01-01

The aim of this study was to perform a systematic review of papers that assess the effect of television food advertisings (TFA) in the food preferences and consumption in different age groups. Randomized clinical trials published up to November 2010 were searched in Pubmed, Ebsco, Cochrane and Scielo. Studies were included if they assessed the effect of direct exposition to TFA over the food preferences, demand, and consumption. Ten studies fulfilled the inclusion criteria. In the three studies conducted on preschooler children an increase in selection and demand of advertized foods was reported. All the fives studies conducted on scholar children reported negative outcomes in those children exposed to unhealthy food. An increase on food consumption was observed in two of the three studies conducted on adults. The assess studies show that in pre-school and school children the effect of advertising on food consumption was consistent, while in adults there is a trend toward an strong association of exposure food advertising and preference, consumption and demand of the food advertised.

Urinary retention: benefit of gradual bladder decompression - myth or truth? A randomized controlled trial.

PubMed

Boettcher, S; Brandt, A S; Roth, S; Mathers, M J; Lazica, D A

2013-01-01

Urinary retention is a common emergency requiring immediate catheterization. Gradual decompression (GD) of the extended bladder is believed to minimize the risk of complications such as bleeding or circulatory collapse, but to date it has not been compared with rapid decompression (RD) in controlled trials. Male patients presenting with urinary retention (n = 294) were randomized to rapid or gradual catheterization. For the latter, the transurethral catheter was clamped for 5 min after every 200-ml outflow until the bladder was completely empty. Patients were monitored for at least 30 min thereafter with regular checks of vital signs and presence of macroscopic hematuria. Of 294 patients, 142 (48.3%) were randomized to the GD and 152 (51.7%) to the RD group. Both groups showed no statistically significant difference with regard to age, anticoagulation treatment, catheter size and material, or volume retained. Hematuria occurred in 16 (11.3%) of the GD and 16 (10.5%) of the RD group; 6 patients in the former and 4 in the latter required further treatment. No circulatory collapse occurred. We noted a decrease in the previously raised blood pressure and heart rate in both groups, although without clinical significance. In this first randomized trial, no statistically significant difference was noted between gradual and rapid emptying of the bladder for urinary retention. Gradual emptying did not reduce the risk of hematuria or circulatory collapse. Therefore, there is no need to prefer gradual over rapid emptying, which is both easy and safe. © 2013 S. Karger AG, Basel.

Estimates of fruit and vegetable intake in childhood and adult dietary behaviors of African American women.

PubMed

Haire-Joshu, Debra; Kreuter, Matthew K; Holt, Cheryl; Steger-May, Karen

2004-01-01

This exploratory study examined how estimates of one's fruit and vegetable intake in childhood are related to 3 current dietary behaviors among African American women: intake of fruits and vegetables, exposure to and preference for fruits and vegetables, and preference for trying new foods. Baseline data from a randomized dietary intervention trial. Ten urban public health centers in St. Louis, Missouri. 1227 African American women. A 33-item fruit and vegetable food frequency questionnaire, items measuring estimates of childhood fruit and vegetable intake, adult fruit and vegetable intake, exposure to and preference for fruit and vegetable, and preference for trying new foods. Linear regression evaluated the association between predictors and continuous measures; logistic regression determined the association between predictors and categorical measures. Estimates of one's vegetable intake as a child were significantly related to exposure and preference for both fruits and vegetables, trying of new foods, and intake of both fruits and vegetables in adulthood. Estimates of eating fruit as a child were not significantly associated with these adult dietary behaviors. Developmental influences on adult dietary patterns may be stronger for vegetables than fruits among African American women. Additional emphasis is needed regarding exposure to and preference for vegetable intake in childhood.

The role of mHealth for improving medication adherence in patients with cardiovascular disease: a systematic review.

PubMed

Gandapur, Yousuf; Kianoush, Sina; Kelli, Heval M; Misra, Satish; Urrea, Bruno; Blaha, Michael J; Graham, Garth; Marvel, Francoise A; Martin, Seth S

2016-10-01

Cardiovascular disease is a leading cause of morbidity and mortality worldwide, and a key barrier to improved outcomes is medication non-adherence. The aim of this study is to review the role of mobile health (mHealth) tools for improving medication adherence in patients with cardiovascular disease. We performed a systematic search for randomized controlled trials that primarily investigated mHealth tools for improving adherence to cardiovascular disease medications in patients with hypertension, coronary artery disease, heart failure, peripheral arterial disease, and stroke. We extracted and reviewed data on the types of mHealth tools used, preferences of patients and healthcare providers, the effect of the mHealth interventions on medication adherence, and the limitations of trials. We identified 10 completed trials matching our selection criteria, mostly with <100 participants, and ranging in duration from 1 to 18 months. mHealth tools included text messages, Bluetooth-enabled electronic pill boxes, online messaging platforms, and interactive voice calls. Patients and healthcare providers generally preferred mHealth to other interventions. All 10 studies reported that mHealth interventions improved medication adherence, though the magnitude of benefit was not consistently large and in one study was not greater than a telehealth comparator. Limitations of trials included small sample sizes, short duration of follow-up, self-reported outcomes, and insufficient assessment of unintended harms and financial implications. Current evidence suggests that mHealth tools can improve medication adherence in patients with cardiovascular diseases. However, high-quality clinical trials of sufficient size and duration are needed to move the field forward and justify use in routine care.

Assessing the impact of user-centered research on a clinical trial eHealth tool via counterbalanced research design

PubMed Central

Massett, Holly A; Mylks, Christy; McCormack, Lauren A; Kish-Doto, Julia; Hesse, Bradford W; Wang, Min Qi

2010-01-01

Objective Informatics applications have the potential to improve participation in clinical trials, but their design must be based on user-centered research. This research used a fully counterbalanced experimental design to investigate the effect of changes made to the original version of a website, http://BreastCancerTrials.org/, and confirm that the revised version addressed and reinforced patients' needs and expectations. Design Participants included women who had received a breast cancer diagnosis within the last 5 years (N=77). They were randomized into two groups: one group used and reviewed the original version first followed by the redesigned version, and the other group used and reviewed them in reverse order. Measurements The study used both quantitative and qualitative measures. During use, participants' click paths and general reactions were observed. After use, participants were asked to answer survey items and open-ended questions to indicate their reactions and which version they preferred and met their needs and expectations better. Results Overall, the revised version of the site was preferred and perceived to be clearer, easier to navigate, more trustworthy and credible, and more private and safe overall. However, users who viewed the original version last had similar attitudes toward both versions. Conclusion By applying research findings to the redesign of a website for clinical trial searching, it was possible to re-engineer the interface to better support patients' decisions to participate in clinical trials. The mechanisms of action in this case appeared to revolve around creating an environment that supported a sense of personal control and decisional autonomy. PMID:21169619

Effect of self-hypnosis on duration of labor and maternal and neonatal outcomes: a randomized controlled trial.

PubMed

Werner, Anette; Uldbjerg, Niels; Zachariae, Robert; Nohr, Ellen A

2013-07-01

To examine the effect of a brief course in self-hypnosis for childbirth on duration of the labor and other birth outcomes. A randomized, controlled, single-blind trial. Aarhus University Hospital Skejby, Denmark. A total of 1222 healthy nulliparous women. A hypnosis group receiving three 1-h lessons in self-hypnosis with additional audio-recordings to ease childbirth, a relaxation group receiving three 1-h lessons in various relaxation methods and mindfulness with audio-recordings for additional training, and a usual-care group receiving only the usual antenatal care were compared. Duration of labor, birth complications, lactation success, caring for the child, and preferred future mode of delivery. No differences were found across the three groups on duration from arriving at the birth department until the expulsive phase of second stage of labor, the duration of the expulsive phase, or other birth outcomes. Fewer emergency and more elective cesarean sections occurred in the hypnosis group. No difference was seen across the groups for lactation success or caring for the child but fewer women in the hypnosis group preferred a cesarean section in future pregnancies because of fear of childbirth and negative birth experiences. Learning self-hypnosis to ease childbirth taught as a brief course failed to show any effects on duration of childbirth and other birth outcomes. © 2013 The Authors Acta Obstetricia et Gynecologica Scandinavica © 2013 Nordic Federation of Societies of Obstetrics and Gynecology.

Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial.

PubMed

Brenner, Alison T; Getrich, Christina M; Pignone, Michael; Rhyne, Robert L; Hoffman, Richard M; McWilliams, Andrew; de Hernandez, Brisa Urquieta; Weaver, Mark A; Tapp, Hazel; Harbi, Khalil; Reuland, Daniel

2014-07-08

Screening can reduce colorectal cancer (CRC) incidence and mortality. However, screening is underutilized in vulnerable patient populations, particularly among Latinos. Patient-directed decision aids can increase CRC screening knowledge, self-efficacy, and intent; however, their effect on actual screening test completion tends to be modest. This is probably because decision aids do not address some of the patient-specific barriers that prevent successful completion of CRC screening in these populations. These individual barriers might be addressed though patient navigation interventions. This study will test a combined decision aid and patient navigator intervention on screening completion in diverse populations of vulnerable primary care patients. We will conduct a multisite, randomized controlled trial with patient-level randomization. Planned enrollment is 300 patients aged 50 to 75 years at average CRC risk presenting for appointments at two primary clinics in North Carolina and New Mexico. Intervention participants will view a video decision aid immediately before the clinic visit. The 14 to 16 minute video presents information about fecal occult blood tests and colonoscopy and will be viewed on a portable computer tablet in English or Spanish. Clinic-based patient navigators are bilingual and bicultural and will provide both face-to-face and telephone-based navigation. Control participants will view an unrelated food safety video and receive usual care. The primary outcome is completion of a CRC screening test at six months. Planned subgroup analyses include examining intervention effectiveness in Latinos, who will be oversampled. Secondarily, the trial will evaluate the intervention effects on knowledge of CRC screening, self-efficacy, intent, and patient-provider communication. The study will also examine whether patient ethnicity, acculturation, language preference, or health insurance status moderate the intervention effect on CRC screening. This pragmatic randomized controlled trial will test a combined decision aid and patient navigator intervention targeting CRC screening completion. Findings from this trial may inform future interventions and implementation policies designed to promote CRC screening in vulnerable patient populations and to reduce screening disparities. ClinicalTrials.gov NCT02054598.

Evaluation of the Cochrane tool for assessing risk of bias in randomized clinical trials: overview of published comments and analysis of user practice in Cochrane and non-Cochrane reviews.

PubMed

Jørgensen, Lars; Paludan-Müller, Asger S; Laursen, David R T; Savović, Jelena; Boutron, Isabelle; Sterne, Jonathan A C; Higgins, Julian P T; Hróbjartsson, Asbjørn

2016-05-10

The Cochrane risk of bias tool for randomized clinical trials was introduced in 2008 and has frequently been commented on and used in systematic reviews. We wanted to evaluate the tool by reviewing published comments on its strengths and challenges and by describing and analysing how the tool is applied to both Cochrane and non-Cochrane systematic reviews. A review of published comments (searches in PubMed, The Cochrane Methodology Register and Google Scholar) and an observational study (100 Cochrane and 100 non-Cochrane reviews from 2014). Our review included 68 comments, 15 of which were categorised as major. The main strengths of the tool were considered to be its aim (to assess trial conduct and not reporting), its developmental basis (wide consultation, empirical and theoretical evidence) and its transparent procedures. The challenges of the tool were mainly considered to be its choice of core bias domains (e.g. not involving funding/conflicts of interest) and issues to do with implementation (i.e. modest inter-rater agreement) and terminology. Our observational study found that the tool was used in all Cochrane reviews (100/100) and was the preferred tool in non-Cochrane reviews (31/100). Both types of reviews frequently implemented the tool in non-recommended ways. Most Cochrane reviews planned to use risk of bias assessments as basis for sensitivity analyses (70 %), but only a minority conducted such analyses (19 %) because, in many cases, few trials were assessed as having "low" risk of bias for all standard domains (6 %). The judgement of at least one risk of bias domain as "unclear" was found in 89 % of included randomized clinical trials (1103/1242). The Cochrane tool has become the standard approach to assess risk of bias in randomized clinical trials but is frequently implemented in a non-recommended way. Based on published comments and how it is applied in practice in systematic reviews, the tool may be further improved by a revised structure and more focused guidance.

The Relaxation Exercise and Social Support Trial (RESST): a community-based randomized controlled trial to alleviate medically unexplained vaginal discharge symptoms.

PubMed

Kobeissi, Loulou; Mahfoud, Ziyad; Khoury, Brigitte; El Kak, Fayssal; Ghantous, Zeina; Khawaja, Marwan; Nakkash, Rima; Ramia, Sami; Zurayk, Huda; Araya, Ricardo; Peters, Tim J

2012-11-09

Symptoms such as medically unexplained vaginal discharge (MUVD) are common and bothersome, leading to potentially unnecessary use of resources. A community-based individually randomized controlled trial to assess the effectiveness of a relatively simple, culturally appropriate multi-component intervention on reducing reported MUVD, among women suffering from low-moderate levels of common mental distress. The setting was a socio-economically deprived, informal settlement in the southern suburbs of Beirut, Lebanon. The intervention comprised up to 12 group sessions implemented over a six-week period, each divided into a psychosocial and a relaxation exercise component. The primary outcome was self-reported MUVD, which was defined as a complaint of vaginal discharge upon ruling out reproductive tract infections (RTIs), through lab analysis. Anxiety and/or depression symptoms were the secondary outcomes for this trial. These were assessed using an Arabic validated version of the Hopkins Symptoms Checklist-25 (HSCL-25). Assessments were done at baseline and six months using face-to face interviews, pelvic examinations and laboratory tests. Women were randomized into either intervention or control group. Blinding on the intervention status was not possible for both logistic and ethical reasons, especially as knowledge of involvement in the intervention was integral to its delivery. Intent to treat analysis was used. Of 75 women randomized to the intervention, 48% reported MUVD at 6 months compared with 63% of 73 in the control group (difference of -15%, 95% confidence interval (CI) -31%, 0%, p=0.067). Adjustments for baseline imbalances and any factors relating to consent had no appreciable effect on these results. The risk of MUVD was reduced in absolute terms by 2.4% for each intervention session attended (95% CI -4.9%, 0.0%, p=0.049). While there was also marginal evidence of a beneficial effect on anxiety, there was no evidence of mediation of the effect on MUVD through measures of common mental disorders. This study confirms that MUVD is an important public health problem. While the benefits of this intervention may appear modest, the intervention offers an opportunity for women to enhance their problem-solving skills as well as use physical relaxation techniques that can help them deal with stressful in their lives. Further research is needed in a variety of contexts, for different populations and preferably involving larger randomized trials of such an intervention. * Title of trial: The Relaxation Exercise and Social Support Trial ISRCTN assigned: ISRCTN98441241 Date of assignation: 10/09/2010 Link: http://www.controlled-trials.com/ISRCTN98441241* Also registered at the Wellcome Trust register:http://www.controlled-trials.com/mrct/trial/469943/98441241.

Difference in plantar pressure between the preferred and non‐preferred feet in four soccer‐related movements

PubMed Central

Wong, Pui‐lam; Chamari, Karim; Chaouachi, Anis; De Wei Mao; Wisløff, Ulrik; Hong, Youlian

2007-01-01

Objective and participants The present study measured the difference in plantar pressure between the preferred and non‐preferred foot in four soccer‐related movements in 15 male university soccer players (mean (SD) age 20.9 (1.3) years, mean (SD) height 173 (4) cm and mean (SD) weight 61.7 (3.6) kg). Design To record plantar pressure distribution, players randomly wore three types of soccer shoes (classical 6‐stud and 12‐stud, and specially designed 12‐stud) embedded with an insole pressure recorder device with 99 sensors, divided into 10 areas for analysis. Plantar pressure was recorded in five successful trials in each of the four soccer‐related movements: running (at 3.3 m/s), sideward cutting, 45° cutting and landing from a vertical jump. Results Plantar pressures of the preferred and non‐preferred foot were different in 115 of 120 comparisons. The overall plantar pressure of the preferred foot was higher than that of the non‐preferred foot. Specifically, in each of the four movements, higher pressure was found in the preferred foot during the take‐off phase, whereas this was found in the non‐preferred foot during the landing phase. This would suggest a tendency of the preferred foot for higher motion force and of the non‐preferred foot for a greater role in body stabilisation. Conclusions The data indicate that the preferred and non‐preferred foot should be treated independently with regard to strength/power training to avoid unnecessary injuries. Different shoes/insoles and different muscular strengthening programmes are thus suggested for each of the soccer player's feet. PMID:17138639

Study protocol for a randomized controlled pilot-trial on the semiocclusive treatment of fingertip amputation injuries using a novel finger cap

PubMed Central

Schultz, Jurek; Leupold, Susann; Grählert, Xina; Pfeiffer, Roland; Schwanebeck, Uta; Schröttner, Percy; Djawid, Barbara; Artsimovich, Wladislav; Kozak, Karol; Fitze, Guido

2017-01-01

Abstract Introduction: Fingertip amputation injuries are common in all ages. Conservatively treated fingertips can regenerate skin and soft tissues to form a functionally and cosmetically excellent new fingertip. Little is known about this ability that, in humans, is confined to the fingertips. Even less is known about the role of the bacteria that regularly colonize these wounds without negative impact on regeneration and healing. As an alternative to surgery, self-adhesive film dressings are commonly used to establish a wet chamber around the injury. These dressings leak malodorous wound fluid eventually until the wound is dry. Having that into consideration, we have therefore developed a silicone finger cap that forms a mechanically protected, wet chamber around the injury for optimal regeneration conditions. It contains a puncturable reservoir for excess wound fluid, which can be thus routinely analyzed for diagnostic and research purposes. This study protocol explains the first randomized controlled trial (RCT) on the semiocclusive treatment of fingertip amputations in both children and adults comparing traditional film dressings with the novel silicone finger cap. Being the first RCT using 2 medical devices not yet certified for this indication, it will gather valuable information for the understanding of fingertip regeneration and the design of future definitive studies. Methods and analysis: By employing an innovative pseudo-cross-over-design with a dichotomous primary endpoint based on patients preference, this pilot study will gain statistically significant data with a very limited sample size. Our RCT will investigate acceptance, safety, effectiveness, and efficacy of this novel medical device while gathering information on the clinical course and outcome of conservatively treated fingertip injuries. A total of 22 patients older than 2 years will be randomly assigned to start the conservative treatment with either the traditional film-dressing or the novel finger cap. The treatment will be changed to the other alternative for another 2 weeks before the patient or the guardian is confronted with the decision of which method they would prefer for the rest of the treatment (if required). Ethics and dissemination: Ethical approval (EK 148042015) of the study protocol has been obtained from Institutional Review Board at the TU Dresden. The trial is registered at the European Database on Medical Devices (EUDAMED-No.: CIV-15-03-013246) and at ClinicalTrials.gov (NCT03089060). PMID:29019891

Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial).

PubMed

van der Sluis, Pieter C; Ruurda, Jelle P; van der Horst, Sylvia; Verhage, Roy J J; Besselink, Marc G H; Prins, Margriet J D; Haverkamp, Leonie; Schippers, Carlo; Rinkes, Inne H M Borel; Joore, Hans C A; Ten Kate, Fiebo Jw; Koffijberg, Hendrik; Kroese, Christiaan C; van Leeuwen, Maarten S; Lolkema, Martijn P J K; Reerink, Onne; Schipper, Marguerite E I; Steenhagen, Elles; Vleggaar, Frank P; Voest, Emile E; Siersema, Peter D; van Hillegersberg, Richard

2012-11-30

For esophageal cancer patients, radical esophagolymphadenectomy is the cornerstone of multimodality treatment with curative intent. Transthoracic esophagectomy is the preferred surgical approach worldwide allowing for en-bloc resection of the tumor with the surrounding lymph nodes. However, the percentage of cardiopulmonary complications associated with the transthoracic approach is high (50 to 70%).Recent studies have shown that robot-assisted minimally invasive thoraco-laparoscopic esophagectomy (RATE) is at least equivalent to the open transthoracic approach for esophageal cancer in terms of short-term oncological outcomes. RATE was accompanied with reduced blood loss, shorter ICU stay and improved lymph node retrieval compared with open esophagectomy, and the pulmonary complication rate, hospital stay and perioperative mortality were comparable. The objective is to evaluate the efficacy, risks, quality of life and cost-effectiveness of RATE as an alternative to open transthoracic esophagectomy for treatment of esophageal cancer. This is an investigator-initiated and investigator-driven monocenter randomized controlled parallel-group, superiority trial. All adult patients (age ≥ 18 and ≤ 80 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) esophageal carcinoma of the intrathoracic esophagus and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n = 112) with resectable esophageal cancer are randomized in the outpatient department to either RATE (n = 56) or open three-stage transthoracic esophageal resection (n = 56). The primary outcome of this study is the percentage of overall complications (grade 2 and higher) as stated by the modified Clavien-Dindo classification of surgical complications. This is the first randomized controlled trial designed to compare RATE with open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer. If our hypothesis is proven correct, RATE will result in a lower percentage of postoperative complications, lower blood loss, and shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with open transthoracic esophagectomy. The study started in January 2012. Follow-up will be 5 years. Short-term results will be analyzed and published after discharge of the last randomized patient. Dutch trial register: NTR3291 ClinicalTrial.gov: NCT01544790.

Cultural beliefs and mental health treatment preferences of ethnically diverse older adult consumers in primary care.

PubMed

Jimenez, Daniel E; Bartels, Stephen J; Cardenas, Veronica; Dhaliwal, Sanam S; Alegría, Margarita

2012-06-01

Beliefs concerning the causes of mental illness may help to explain why there are significant disparities in the rates of formal mental health service use among racial/ethnic minority elderly as compared with their white counterparts. This study applies the cultural influences on mental health framework to identify the relationship between race/ethnicity and differences in 1) beliefs on the cause of mental illness, 2) preferences for type of treatment, and 3) provider characteristics. Analyses were conducted using baseline data collected from participants who completed the cultural attitudes toward healthcare and mental illness questionnaire, developed for the Primary Care Research in Substance Abuse and Mental Health for the Elderly study, a multisite randomized trial for older adults (65+) with depression, anxiety, or at-risk alcohol consumption. The final sample consisted of 1,257 non-Latino whites, 536 African Americans, 112 Asian Americans, and 303 Latinos. African Americans, Asian Americans, and Latinos had differing beliefs regarding the causes of mental illness when compared with non-Latino whites. Race/ethnicity was also associated with determining who makes healthcare decisions, treatment preferences, and preferred characteristics of healthcare providers. This study highlights the association between race/ethnicity and health beliefs, treatment preferences, healthcare decisions, and consumers' preferred characteristics of healthcare providers. Accommodating the values and preferences of individuals can be helpful in engaging racial/ethnic minority patients in mental health services.

Update on mechanical cardiopulmonary resuscitation devices.

PubMed

Rubertsson, Sten

2016-06-01

The aim of this review is to update and discuss the use of mechanical chest compression devices in treatment of cardiac arrest. Three recently published large multicenter randomized trials have not been able to show any improved outcome in adult out-of-hospital cardiac arrest patients when compared with manual chest compressions. Mechanical chest compression devices have been developed to better deliver uninterrupted chest compressions of good quality. Prospective large randomized studies have not been able to prove a better outcome compared to manual chest compressions; however, latest guidelines support their use when high-quality manual chest compressions cannot be delivered. Mechanical chest compressions can also be preferred during transportation, in the cath-lab and as a bridge to more invasive support like extracorporeal membrane oxygenation.

Baby Shampoo versus Commercial Anti-fogging Solution to Prevent Fogging during Nasal Endoscopy: A Randomized Double-Blinded, Matched-Pair, Equivalent Trial.

PubMed

Chainansamit, Seksun; Piromchai, Patorn; Anantpinijwatna, Intira; Kasemsiri, Pornthep; Thanaviratananich, Sanguansak

2015-08-01

To compare the minimization of the fog condensation during nasal endoscopy between a commercial anti-fogging agent and baby shampoo. This randomized double-blinded matched pair study was conducted at the Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen University during February 4, 2013 to March 14, 2013. The commercial anti-fogging solution (Ultrastop®) and baby shampoo solution (Johnson's® no more tear®) were compared. A computer generated randomization was performed to select the solution applying on the lens for nasal endoscopy of the right nasal cavity. The other solution was then used for the left one. Three passes of endoscopy were performed to examine the floor of the nose, the sphenoethmoidal recess and the middle meatus area which spent about 30 seconds for each time of endoscopy. The time to become foggy on the lens and the preferred solution assessed by the endoscopists were recorded. There were 71 eligible patients recruited in the study, 37 males (52.1%) and 34 females (47.9%). There was no fogging during a 30-second nasal endoscopy either by baby shampoo or commercial anti-fogging solution. However, 9.86% (95% C12.75-16.97) of endoscopists preferred commercial anti-fogging agent, 7.04% (95% CI 0.94-13.14) preferred baby shampoo and 83.10% (95% CI 74.16-92.03) had equal satisfaction. Both agents had no statistically significant difference for preventing foggy on the lens. Baby shampoo is an effective agent to prevent fogging during nasal endoscopy and comparable with the commercial anti-fogging agent.

Perioperative strategy in colonic surgery; LAparoscopy and/or FAst track multimodal management versus standard care (LAFA trial)

PubMed Central

Wind, Jan; Hofland, Jan; Preckel, Benedikt; Hollmann, Markus W; Bossuyt, Patrick MM; Gouma, Dirk J; van Berge Henegouwen, Mark I; Fuhring, Jan Willem; Dejong, Cornelis HC; van Dam, Ronald M; Cuesta, Miguel A; Noordhuis, Astrid; de Jong, Dick; van Zalingen, Edith; Engel, Alexander F; Goei, T Hauwy; de Stoppelaar, I Erica; van Tets, Willem F; van Wagensveld, Bart A; Swart, Annemiek; van den Elsen, Maarten JLJ; Gerhards, Michael F; de Wit, Laurens Th; Siepel, Muriel AM; van Geloven, Anna AW; Juttmann, Jan-Willem; Clevers, Wilfred; Bemelman, Willem A

2006-01-01

Background Recent developments in large bowel surgery are the introduction of laparoscopic surgery and the implementation of multimodal fast track recovery programs. Both focus on a faster recovery and shorter hospital stay. The randomized controlled multicenter LAFA-trial (LAparoscopy and/or FAst track multimodal management versus standard care) was conceived to determine whether laparoscopic surgery, fast track perioperative care or a combination of both is to be preferred over open surgery with standard care in patients having segmental colectomy for malignant disease. Methods/design The LAFA-trial is a double blinded, multicenter trial with a 2 × 2 balanced factorial design. Patients eligible for segmental colectomy for malignant colorectal disease i.e. right and left colectomy and anterior resection will be randomized to either open or laparoscopic colectomy, and to either standard care or the fast track program. This factorial design produces four treatment groups; open colectomy with standard care (a), open colectomy with fast track program (b), laparoscopic colectomy with standard care (c), and laparoscopic surgery with fast track program (d). Primary outcome parameter is postoperative hospital length of stay including readmission within 30 days. Secondary outcome parameters are quality of life two and four weeks after surgery, overall hospital costs, morbidity, patient satisfaction and readmission rate. Based on a mean postoperative hospital stay of 9 +/- 2.5 days a group size of 400 patients (100 each arm) can reliably detect a minimum difference of 1 day between the four arms (alfa = 0.95, beta = 0.8). With 100 patients in each arm a difference of 10% in subscales of the Short Form 36 (SF-36) questionnaire and social functioning can be detected. Discussion The LAFA-trial is a randomized controlled multicenter trial that will provide evidence on the merits of fast track perioperative care and laparoscopic colorectal surgery in patients having segmental colectomy for malignant disease. PMID:17134506

A comparison of web-based versus print-based decision AIDS for prostate cancer screening: participants' evaluation and utilization.

PubMed

Tomko, Catherine; Davis, Kimberly M; Luta, George; Krist, Alexander H; Woolf, Steven H; Taylor, Kathryn L

2015-01-01

Patient decision aids facilitate informed decision making for medical tests and procedures that have uncertain benefits. To describe participants' evaluation and utilization of print-based and web-based prostate cancer screening decision aids that were found to improve decisional outcomes in a prior randomized controlled trial. Men completed brief telephone interviews at baseline, one month, and 13 months post-randomization. Participants were primary care patients, 45-70 years old, who received the print-based (N = 628) or web-based decision aid (N = 625) and completed the follow-up assessments. We assessed men's baseline preference for web-based or print-based materials, time spent using the decision aids, comprehension of the overall message, and ratings of the content. Decision aid use was self-reported by 64.3 % (web) and 81.8 % (print) of participants. Significant predictors of decision aid use were race (white vs. non-white, OR = 2.43, 95 % CI: 1.77, 3.35), higher education (OR = 1.68, 95 % CI: 1.06, 2.70) and trial arm (print vs. web, OR = 2.78, 95 % CI: 2.03, 3.83). Multivariable analyses indicated that web-arm participants were more likely to use the website when they preferred web-based materials (OR: 1.91, CI: 1.17, 3.12), whereas use of the print materials was not significantly impacted by a preference for print-based materials (OR: 0.69, CI: 0.38, 1.25). Comprehension of the decision aid message (i.e., screening is an individual decision) did not significantly differ between arms in adjusted analyses (print: 61.9 % and web: 68.2 %, p = 0.42). Decision aid use was independently influenced by race, education, and the decision aid medium, findings consistent with the 'digital divide.' These results suggest that when it is not possible to provide this age cohort with their preferred decision aid medium, print materials will be more highly used than web-based materials. Although there are many advantages to web-based decision aids, providing an option for print-based decision aids should be considered.

Clinical learning experiences of nursing students using an innovative clinical partnership model: A non-randomized controlled trial.

PubMed

Chan, Aileen W K; Tang, Fiona W K; Choi, Kai Chow; Liu, Ting; Taylor-Piliae, Ruth E

2018-06-05

Clinical practicum is a major learning component for pre-registration nursing students. Various clinical practicum models have been used to facilitate students' clinical learning experiences, employing both university-based and hospital-based clinical teachers. Considering the strengths and limitations of these clinical practicum models, along with nursing workforce shortages, we developed and tested an innovative clinical partnership model (CPM) in Hong Kong. To evaluate an innovative CPM among nursing students actual and preferred clinical learning environment, compared with a conventional facilitation model (CFM). A non-randomized controlled trial examining students' clinical experiences, comparing the CPM (supervised by hospital clinical teacher) with the CFM (supervised by university clinical teacher). One university in Hong Kong. Pre-registration nursing students (N = 331), including bachelor of nursing (n = 246 year three-BN) and masters-entry nursing (n = 85 year one-MNSP). Students were assigned to either the CPM (n = 48 BN plus n = 85 MNSP students) or the CFM (n = 198 BN students) for their clinical practice experiences in an acute medical-surgical ward. Clinical teachers supervised between 6 and 8 students at a time, during these clinical practicums (duration = 4-6 weeks). At the end of the clinical practicum, students were invited to complete the Clinical Learning Environment Inventory (CLEI). Analysis of covariance was used to compare groups; adjusted for age, gender and prior work experience. A total of 259 students (mean age = 22 years, 76% female, 81% prior work experience) completed the CLEI (78% response rate). Students had higher scores on preferred versus actual experiences, in all domains of the CLEI. CPM student experiences indicated a higher preferred task orientation (p = 0.004), while CFM student experiences indicated a higher actual (p < 0.001) and preferred individualization (p = 0.005). No significant differences were noted in the other domains. The CPM draws on the strengths of existing clinical learning models and provides complementary methods to facilitate clinical learning for pre-registration nursing students. Additional studies examining this CPM with longer duration of clinical practicum are recommended. Copyright © 2018 Elsevier Ltd. All rights reserved.

Support of personalized medicine through risk-stratified treatment recommendations - an environmental scan of clinical practice guidelines

PubMed Central

2013-01-01

Background Risk-stratified treatment recommendations facilitate treatment decision-making that balances patient-specific risks and preferences. It is unclear if and how such recommendations are developed in clinical practice guidelines (CPGs). Our aim was to assess if and how CPGs develop risk-stratified treatment recommendations for the prevention or treatment of common chronic diseases. Methods We searched the United States National Guideline Clearinghouse for US, Canadian and National Institute for Health and Clinical Excellence (United Kingdom) CPGs for heart disease, stroke, cancer, chronic obstructive pulmonary disease and diabetes that make risk-stratified treatment recommendations. We included only those CPGs that made risk-stratified treatment recommendations based on risk assessment tools. Two reviewers independently identified CPGs and extracted information on recommended risk assessment tools; type of evidence about treatment benefits and harms; methods for linking risk estimates to treatment evidence and for developing treatment thresholds; and consideration of patient preferences. Results We identified 20 CPGs that made risk-stratified treatment recommendations out of 133 CPGs that made any type of treatment recommendations for the chronic diseases considered in this study. Of the included 20 CPGs, 16 (80%) used evidence about treatment benefits from randomized controlled trials, meta-analyses or other guidelines, and the source of evidence was unclear in the remaining four (20%) CPGs. Nine CPGs (45%) used evidence on harms from randomized controlled trials or observational studies, while 11 CPGs (55%) did not clearly refer to harms. Nine CPGs (45%) explained how risk prediction and evidence about treatments effects were linked (for example, applying estimates of relative risk reductions to absolute risks), but only one CPG (5%) assessed benefit and harm quantitatively and three CPGs (15%) explicitly reported consideration of patient preferences. Conclusions Only a small proportion of CPGs for chronic diseases make risk-stratified treatment recommendations with a focus on heart disease and stroke prevention, diabetes and breast cancer. For most CPGs it is unclear how risk-stratified treatment recommendations were developed. As a consequence, it is uncertain if CPGs support patients and physicians in finding an acceptable benefit- harm balance that reflects both profile-specific outcome risks and preferences. PMID:23302096

Coaching and guidance with patient decision aids: A review of theoretical and empirical evidence

PubMed Central

2013-01-01

Background Coaching and guidance are structured approaches that can be used within or alongside patient decision aids (PtDAs) to facilitate the process of decision making. Coaching is provided by an individual, and guidance is embedded within the decision support materials. The purpose of this paper is to: a) present updated definitions of the concepts “coaching” and “guidance”; b) present an updated summary of current theoretical and empirical insights into the roles played by coaching/guidance in the context of PtDAs; and c) highlight emerging issues and research opportunities in this aspect of PtDA design. Methods We identified literature published since 2003 on shared decision making theoretical frameworks inclusive of coaching or guidance. We also conducted a sub-analysis of randomized controlled trials included in the 2011 Cochrane Collaboration Review of PtDAs with search results updated to December 2010. The sub-analysis was conducted on the characteristics of coaching and/or guidance included in any trial of PtDAs and trials that allowed the impact of coaching and/or guidance with PtDA to be compared to another intervention or usual care. Results Theoretical evidence continues to justify the use of coaching and/or guidance to better support patients in the process of thinking about a decision and in communicating their values/preferences with others. In 98 randomized controlled trials of PtDAs, 11 trials (11.2%) included coaching and 63 trials (64.3%) provided guidance. Compared to usual care, coaching provided alongside a PtDA improved knowledge and decreased mean costs. The impact on some other outcomes (e.g., participation in decision making, satisfaction, option chosen) was more variable, with some trials showing positive effects and other trials reporting no differences. For values-choice agreement, decisional conflict, adherence, and anxiety there were no differences between groups. None of these outcomes were worse when patients were exposed to decision coaching alongside a PtDA. No trials evaluated the effect of guidance provided within PtDAs. Conclusions Theoretical evidence continues to justify the use of coaching and/or guidance to better support patients to participate in decision making. However, there are few randomized controlled trials that have compared the effectiveness of coaching used alongside PtDAs to PtDAs without coaching, and no trials have compared the PtDAs with guidance to those without guidance. PMID:24624995

Morning versus evening induction of labour for improving outcomes.

PubMed

Bakker, Jannet J H; van der Goes, Birgit Y; Pel, Maria; Mol, Ben Willem J; van der Post, Joris A M

2013-02-28

Induction of labour is a common intervention in obstetric practice. Traditionally, in most hospitals induction of labour with medication starts early in the morning, with the start of the working day for the day shift. In human and animal studies spontaneous onset of labour is proven to have a circadian rhythm with a preference for start of labour in the evening. Moreover, when spontaneous labour starts in the evening, the total duration of labour and delivery shortens and fewer obstetric interventions are needed. Based on these observations one might assume that starting induction of labour in the evening, in harmony with the circadian rhythm of natural birth, is more beneficial for both mother and child. To assess whether induction of labour starting in the evening, coinciding with the endogenous circadian rhythm, improves the outcome of labour compared with induction of labour starting in the early morning, organised to coincide with office hours. We contacted the Trials Search Co-ordinator to search the Cochrane Pregnancy and Childbirth Group's Trials Register (28 February 2012). In addition, we searched MEDLINE (1966 to 16 February 2012) and EMBASE (1980 to 16 February 2012). We included all published and unpublished randomised controlled trials. We excluded trials that employed quasi-random methods of treatment allocation. Two review authors independently assessed trials for inclusion and risk of bias. Two review authors independently extracted data. Data were checked for accuracy. Where necessary, we contacted study authors for additional information. The search resulted in 2693 articles that we screened on title and abstract for eligibility.Thirteen studies were selected for full text assessment. We included three randomised trials involving 1150 women. Two trials compared the administration of prostaglandins in the morning versus the evening in women with an unfavourable cervix, and one trial compared induction of labour in the morning versus the evening in women with a favourable cervix and/or ruptured membranes with intravenous oxytocin. Because of the different mechanism, we have reported results for these two comparisons separately.In the two trials comparing prostaglandins in the morning versus the evening there were few clinically significant differences between study groups for maternal or neonatal outcomes. One study reported a statistically significant preference by women to start induction of labour with prostaglandins in the morning.In the trial examining induction of labour with intravenous oxytocin, the number of neonatal admissions was statistically significantly increased in the group of women that started induction in the morning. This finding was unexpected, and while the trial authors offered some possible explanations for this, it is important that any future trials examine neonatal outcomes. Taking into account women's preferences that favoured administration of prostaglandins in the morning, we conclude that caregivers should preferably consider administering prostaglandins in the morning.There is no strong evidence that induction of labour with intravenous oxytocin in the evening is more or less effective than induction in the morning. Consideration may be given to start induction of labour with oxytocin in the evening when indicated.

Semi-Individualized Homeopathy Add-On Versus Usual Care Only for Premenstrual Disorders: A Randomized, Controlled Feasibility Study.

PubMed

Klein-Laansma, Christien T; Jong, Mats; von Hagens, Cornelia; Jansen, Jean Pierre C H; van Wietmarschen, Herman; Jong, Miek C

2018-03-22

Premenstrual syndrome and premenstrual dysphoric disorder (PMS/PMDD) bother a substantial number of women. Homeopathy seems a promising treatment, but it needs investigation using reliable study designs. The feasibility of organizing an international randomized pragmatic trial on a homeopathic add-on treatment (usual care [UC] + HT) compared with UC alone was evaluated. A multicenter, randomized, controlled pragmatic trial with parallel groups. The study was organized in general and private homeopathic practices in the Netherlands and Sweden and in an outpatient university clinic in Germany. Women diagnosed as having PMS/PMDD, based on prospective daily rating by the daily record of severity of problems (DRSP) during a period of 2 months, were included and randomized. Women were to receive UC + HT or UC for 4 months. Homeopathic medicine selection was according to a previously tested prognostic questionnaire and electronic algorithm. Usual care was as provided by the women's general practitioner according to their preferences. Before and after treatment, the women completed diaries (DRSP), the measure yourself concerns and well-being, and other questionnaires. Intention-to-treat (ITT) and per protocol (PP) analyses were performed. In Germany, the study could not proceed because of legal limitations. In Sweden, recruitment proved extremely difficult. In the Netherlands and Sweden, 60 women were randomized (UC + HT: 28; UC: 32), data of 47/46 women were analyzed (ITT/PP). After 4 months, relative mean change of DRSP scores in the UC + HT group was significantly better than in the UC group (p = 0.03). With respect to recruitment and different legal status, it does not seem feasible to perform a larger, international, pragmatic randomized trial on (semi-)individualized homeopathy for PMS/PMDD. Since the added value of HT compared with UC was demonstrated by significant differences in symptom score changes, further studies are warranted.

A randomized clinical trial of cognitive behavioral therapy and interpersonal psychotherapy for panic disorder with agoraphobia.

PubMed

Vos, S P F; Huibers, M J H; Diels, L; Arntz, A

2012-12-01

Interpersonal psychotherapy (IPT) seems to be as effective as cognitive behavioral therapy (CBT) in the treatment of major depression. Because the onset of panic attacks is often related to increased interpersonal life stress, IPT has the potential to also treat panic disorder. To date, a preliminary open trial yielded promising results but there have been no randomized controlled trials directly comparing CBT and IPT for panic disorder. This study aimed to directly compare the effects of CBT versus IPT for the treatment of panic disorder with agoraphobia. Ninety-one adult patients with a primary diagnosis of DSM-III or DSM-IV panic disorder with agoraphobia were randomized. Primary outcomes were panic attack frequency and an idiosyncratic behavioral test. Secondary outcomes were panic and agoraphobia severity, panic-related cognitions, interpersonal functioning and general psychopathology. Measures were taken at 0, 3 and 4 months (baseline, end of treatment and follow-up). Intention-to-treat (ITT) analyses on the primary outcomes indicated superior effects for CBT in treating panic disorder with agoraphobia. Per-protocol analyses emphasized the differences between treatments and yielded larger effect sizes. Reductions in the secondary outcomes were equal for both treatments, except for agoraphobic complaints and behavior and the credibility ratings of negative interpretations of bodily sensations, all of which decreased more in CBT. CBT is the preferred treatment for panic disorder with agoraphobia compared to IPT. Mechanisms of change should be investigated further, along with long-term outcomes.

The Traditional Chinese Medicine and Relevant Treatment for the Efficacy and Safety of Atopic Dermatitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

PubMed Central

Shi, Zhao-feng; Song, Tie-bing; Xie, Juan; Yan, Yi-quan

2017-01-01

Background Atopic dermatitis (AD) has become a common skin disease that requires systematic and comprehensive treatment to achieve adequate clinical control. Traditional Chinese medicines and related treatments have shown clinical effects for AD in many studies. But the systematic reviews and meta-analyses for them are lacking. Objective The systematic review and meta-analysis based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement were conducted to evaluate the efficacy and safety of traditional Chinese medicines and related treatments for AD treatment. Methods Randomized controlled trials (RCTs) were searched based on standardized searching rules in eight medical databases from the inception up to December 2016 and a total of 24 articles with 1,618 patients were enrolled in this meta-analysis. Results The results revealed that traditional Chinese medicines and related treatments did not show statistical differences in clinical effectiveness, SCORAD amelioration, and SSRI amelioration for AD treatment compared with control group. However, EASI amelioration of traditional Chinese medicines and related treatments for AD was superior to control group. Conclusion We need to make conclusion cautiously for the efficacy and safety of traditional Chinese medicine and related treatment on AD therapy. More standard, multicenter, double-blind randomized controlled trials (RCTs) of traditional Chinese medicine and related treatment for AD were required to be conducted for more clinical evidences providing in the future. PMID:28713436

The effect on teenage risky driving of feedback from a safety monitoring system: a randomized controlled trial.

PubMed

Simons-Morton, Bruce G; Bingham, C Raymond; Ouimet, Marie Claude; Pradhan, Anuj K; Chen, Rusan; Barretto, Andrea; Shope, Jean T

2013-07-01

Teenage risky driving may be due to teenagers not knowing what is risky, preferring risk, or the lack of consequences. Elevated gravitational-force (g-force) events, caused mainly by hard braking and sharp turns, provide a valid measure of risky driving and are the target of interventions using in-vehicle data recording and feedback devices. The effect of two forms of feedback about risky driving events to teenagers only or to teenagers and their parents was tested in a randomized controlled trial. Ninety parent-teen dyads were randomized to one of two groups: (1) immediate feedback to teens (Lights Only); or (2) immediate feedback to teens plus family access to event videos and ranking of the teen relative to other teenage drivers (Lights Plus). Participants' vehicles were instrumented with data recording devices and events exceeding .5 g were assessed for 2 weeks of baseline and 13 weeks of feedback. Growth curve analysis with random slopes yielded a significant decrease in event rates for the Lights Plus group (slope = -.11, p < .01), but no change for the Lights Only group (slope = .05, p = .67) across the 15 weeks. A large effect size of 1.67 favored the Lights Plus group. Provision of feedback with possible consequences associated with parents being informed reduced risky driving, whereas immediate feedback only to teenagers did not. Published by Elsevier Inc.

Online, Interactive Option Grid Patient Decision Aids and their Effect on User Preferences.

PubMed

Scalia, Peter; Durand, Marie-Anne; Kremer, Jan; Faber, Marjan; Elwyn, Glyn

2018-01-01

Randomized trials have shown that patient decision aids can modify users' preferred healthcare options, but research has yet to identify the attributes embedded in these tools that cause preferences to shift. The aim of this study was to investigate people's preferences as they used decision aids for 5 health decisions and, for each of the following: 1) determine if using the interactive Option Grid led to a pre-post shift in preferences; 2) determine which frequently asked questions (FAQs) led to preference shifts; 3) determine the FAQs that were rated as the most important as users compared options. Interactive Option Grid decision aids enable users to view attributes of available treatment or screening options, rate their importance, and specify their preferred options before and after decision aid use. The McNemar-Bowker paired test was used to compare stated pre-post preferences. Multinomial logistic regressions were conducted to investigate possible associations between covariates and preference shifts. Overall, 626 users completed the 5 most-used tools: 1) Amniocentesis test: yes or no? ( n = 73); 2) Angina: treatment options ( n = 88); 3) Breast cancer: surgical options ( n = 265); 4) Prostate Specific Antigen (PSA) test: yes or no? ( n = 82); 5) Statins for heart disease risk: yes or no? ( n = 118). The breast cancer, PSA, and statins Option Grid decision aids generated significant preference shifts. Generally, users shifted their preference when presented with the description of the available treatment options, and the risk associated with each option. The use of decision aids for some, but not all health decisions, was accompanied by a shift in user preferences. Users typically valued information associated with risks, and chose more risk averse options after completing the interactive tool.

Systematic review and meta-analysis of serious infections with tofacitinib and biologic disease-modifying antirheumatic drug treatment in rheumatoid arthritis clinical trials.

PubMed

Strand, Vibeke; Ahadieh, Sima; French, Jonathan; Geier, Jamie; Krishnaswami, Sriram; Menon, Sujatha; Checchio, Tina; Tensfeldt, Thomas G; Hoffman, Elaine; Riese, Richard; Boy, Mary; Gómez-Reino, Juan J

2015-12-15

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Tofacitinib modulates the signaling of cytokines that are integral to lymphocyte activation, proliferation, and function. Thus, tofacitinib therapy may result in suppression of multiple elements of the immune response. Serious infections have been reported in tofacitinib RA trials. However, limited head-to-head comparator data were available within the tofacitinib RA development program to directly compare rates of serious infections with tofacitinib relative to biologic agents, and specifically adalimumab (employed as an active control agent in two randomized controlled trials of tofacitinib). A systematic literature search of data from interventional randomized controlled trials and long-term extension studies with biologics in RA was carried out. Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) consensus was followed for reporting results of the review and meta-analysis. Incidence rates (unique patients with events/100 patient-years) for each therapy were estimated based on data from randomized controlled trials and long-term extension studies using a random-effects model. Relative and absolute risk comparisons versus placebo used Mantel-Haenszel methods. The search produced 657 hits. In total, 66 randomized controlled trials and 22 long-term extension studies met the selection criteria. Estimated incidence rates (95% confidence intervals [CIs]) for abatacept, rituximab, tocilizumab, and tumor necrosis factor inhibitors were 3.04 (2.49, 3.72), 3.72 (2.99, 4.62), 5.45 (4.26, 6.96), and 4.90 (4.41, 5.44), respectively. Incidence rates (95% CIs) for tofacitinib 5 and 10 mg twice daily (BID) in phase 3 trials were 3.02 (2.25, 4.05) and 3.00 (2.24, 4.02), respectively. Corresponding incidence rates in long-term extension studies were 2.50 (2.05, 3.04) and 3.19 (2.74, 3.72). The risk ratios (95% CIs) versus placebo for tofacitinib 5 and 10 mg BID were 2.21 (0.60, 8.14) and 2.02 (0.56, 7.28), respectively. Risk differences (95% CIs) versus placebo for tofacitinib 5 and 10 mg BID were 0.38% (-0.24%, 0.99%) and 0.40% (-0.22%, 1.02%), respectively. In interventional studies, the risk of serious infections with tofacitinib is comparable to published rates for biologic disease-modifying antirheumatic drugs in patients with moderate to severely active RA.

Formatting modifications in GRADE evidence profiles improved guideline panelists comprehension and accessibility to information. A randomized trial.

PubMed

Vandvik, Per Olav; Santesso, Nancy; Akl, Elie A; You, John; Mulla, Sohail; Spencer, Frederick A; Johnston, Bradley C; Brozek, Jan; Kreis, Julia; Brandt, Linn; Zhou, Qi; Schünemann, Holger J; Guyatt, Gordon

2012-07-01

To determine the effects of formatting alternatives in Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence profiles on guideline panelists' preferences, comprehension, and accessibility. We randomized 116 antithrombotic therapy guideline panelists to review one of two table formats with four formatting alternatives. After answering relevant questions, panelists reviewed the other format and reported their preferences for specific formatting alternatives. Panelists (88 of 116 invited [76%]) preferred presentation of study event rates over no study event rates (median 1 [interquartile range (IQR) 1] on 1-7 scale), absolute risk differences over absolute risks (median 2 [IQR 3]), and additional information in table cells over footnotes (median 1 [IQR 2]). Panelists presented with time frame information in the tables, and not only in footnotes, were more likely to correctly answer questions regarding time frame (58% vs. 11%, P<0.0001), and those presented with risk differences and not absolute risks were more likely to correctly interpret confidence intervals for absolute effects (95% vs. 54%, P<0.0001). Information was considered easy to find, easy to comprehend, and helpful in making recommendations regardless of table format (median 6, IQR 0-1). Panelists found information in GRADE evidence profiles accessible. Correct comprehension of some key information was improved by providing additional information in table and presenting risk differences. Copyright © 2012 Elsevier Inc. All rights reserved.

Non-entry of eligible patients into the Australasian Laparoscopic Colon Cancer Study.

PubMed

Abraham, Ned S; Hewett, Peter; Young, Jane M; Solomon, Michael J

2006-09-01

There is currently a need to assess the reasons for non-entry of eligible patients into surgical randomized controlled trials to determine measures to improve the low recruitment rates in such trials. Reasons for non-entry of all eligible patients not recruited into the Australasian Laparoscopic Colon Cancer Study were prospectively recorded using a survey completed by the participating surgeons for a period of 6 months. In the 6-month period of the study, 51 (45%) out of 113 eligible patients examined by the 18 actively participating surgeons were recruited into the trial. Eighty-nine reasons were recorded for the non-entry of the 62 eligible patients. The most commonly recorded reason was preference for one form of surgery (42%) or the surgeon (31%) by the patient (45 patients (73%) in total). This was followed by lack of time (10 patients (16%)), hospital accreditation (7 patients (11%)) or staffing/equipment (6 patients (10%)). Concern about the doctor-patient relationship or causing the patient anxiety was recorded for three (5%) and two (3%) patients, respectively. Recruitment was positively associated with the availability of a data manager (chi2 = 19.91; P < 0.001, odds ratio (95% confidence interval) = 9.50 (3.53-25.53)) and negatively associated with an increased caseload (more than five eligible patients seen by the surgeon in the study period) (continuity adjusted chi2 = 16.052; P < 0.001, odds ratio (95% confidence interval) = 0.11(0.04-0.30)). Having a preference for one form of surgery by the patient or the surgeon was the most common reason for non-entry of eligible patients in the Australasian Laparoscopic Colon Cancer Study. Concern about the doctor-patient relationship played a minimal role in determining the outcome of recruitment. Patient and surgeon preferences, caseload and the distribution of supportive staff such as data managers according to patient population density should be considered in the planning of future trials.

Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot randomized controlled trial.

PubMed

Causarano, Natalie; Platt, Jennica; Baxter, Nancy N; Bagher, Shaghayegh; Jones, Jennifer M; Metcalfe, Kelly A; Hofer, Stefan O P; O'Neill, Anne C; Cheng, Terry; Starenkyj, Elizabeth; Zhong, Toni

2015-05-01

Breast cancer survivors who make preference-sensitive decisions about postmastectomy breast reconstruction often have large gaps in knowledge and undergo procedures that are misaligned with their treatment goals. We evaluated the feasibility and effect of a pre-consultation educational group intervention on the decision-making process for breast reconstruction. We conducted a pilot randomized controlled trial (RCT) where participants were randomly assigned to the intervention with routine education or routine education alone. The outcomes evaluated were decisional conflict, decision self-efficacy, satisfaction with information, perceived involvement in care, and uptake of reconstruction following surgical consultation. Trial feasibility and acceptability were evaluated, and effect sizes were calculated to determine the primary outcome for the full-scale RCT. Of the 41 patients enrolled, recruitment rate was 72 %, treatment fidelity was 98 %, and retention rate was 95 %. The Cohen's d effect size in reduction of decisional conflict was moderate to high for the intervention group compared to routine education (0.69, 95 % CI = 0.02-1.42), while the effect sizes of increase in decision self-efficacy (0.05, 95 % CI = -0.60-0.71) and satisfaction with information (0.11, 95 % CI = -0.53-0.76) were small. A higher proportion of patients receiving routine education signed informed consent to undergo breast reconstruction (14/20 or 70 %) compared to the intervention group (8/21 or 38 %) P = 0.06. A pre-consultation educational group intervention improves patients' shared decision-making quality compared to routine preoperative patient education. A full-scale definitive RCT is warranted based on high feasibility outcomes, and the primary outcome for the main trial will be decisional conflict.

Do clinicians want recommendations? A multi-center study comparing evidence summaries with and without GRADE recommendations.

PubMed

Neumann, Ignacio; Alonso-Coello, Pablo; Vandvik, Per Olav; Agoritsas, Thomas; Mas, Gemma; Akl, Elie A; Brignardello-Petersen, Romina; Emparanza, Jose; McCullagh, Lauren; De Sitio, Catherine; McGinn, Thomas; Almodaimegh, Hind; Almodaimegh, Khalid; Rivera, Solange; Rojas, Luis; Stirnemann, Jérôme; Irani, Jihad; Hlais, Sani; Mustafa, Reem; Bdair, Fadi; Aly, Abdelrahman; Kristiansen, Annette; Izcovich, Ariel; Ramirez, Anggie; Brozek, Jan; Guyatt, Gordon; Schünemann, Holger J

2018-03-09

Evidence-based clinical practice guidelines provide recommendations to assist clinicians in decision-making and to reduce the gap between best current research evidence and clinical practice. However, some argue that providing pre-appraised evidence summaries alone, rather than recommendations, is more appropriate. To evaluate clinicians' preferences, understanding of the evidence and intended course of action in response to evidence summaries with and without recommendations. We included practicing clinicians attending educational sessions across 10 countries. Clinicians were randomized to receive relevant clinical scenarios supported by research evidence of low or very-low certainty, and accompanied by either strong or weak recommendations developed with the GRADE system. Within each group, participants were further randomized to receive the recommendation plus the corresponding evidence summary or the evidence summary alone. We evaluated participants' preferences and understanding for the presentation strategy as well as their intended course of action. 189/219 (86%) and 201/248 (81%) participants preferred having recommendations accompanying evidence summaries for both strong and weak recommendations, respectively. Across all scenarios less than half of participants correctly interpreted information provided in the evidences summaries (e.g. estimates of effect, certainty in the research evidence). Presence of a recommendation resulted in a more appropriate intended course of action for two scenarios involving strong recommendations. Evidence summaries alone are not enough to impact clinicians' course of action. Clinicians clearly prefer having recommendations accompanying evidence summaries in the context of low or very-low certainty of evidence (Trial registration NCT02006017). Copyright © 2018 Elsevier Inc. All rights reserved.

Knowledge translation strategies for enhancing nurses' evidence-informed decision making: a scoping review.

PubMed

Yost, Jennifer; Thompson, David; Ganann, Rebecca; Aloweni, Fazila; Newman, Kristine; McKibbon, Ann; Dobbins, Maureen; Ciliska, Donna

2014-06-01

Nurses are increasingly expected to engage in evidence-informed decision making (EIDM); the use of research evidence with information about patient preferences, clinical context and resources, and their clinical expertise in decision making. Strategies for enhancing EIDM have been synthesized in high-quality systematic reviews, yet most relate to physicians or mixed disciplines. Existing reviews, specific to nursing, have not captured a broad range of strategies for promoting the knowledge and skills for EIDM, patient outcomes as a result of EIDM, or contextual information for why these strategies "work." To conduct a scoping review to identify and map the literature related to strategies implemented among nurses in tertiary care for promoting EIDM knowledge, skills, and behaviours, as well as patient outcomes and contextual implementation details. A search strategy was developed and executed to identify relevant research evidence. Participants included registered nurses, clinical nurse specialists, nurse practitioners, and advanced practice nurses. Strategies were those enhancing nurses' EIDM knowledge, skills, or behaviours, as well as patient outcomes. Relevant studies included systematic reviews, randomized controlled trials, cluster randomized controlled trials, non-randomized trials (including controlled before and after studies), cluster non-randomized trials, interrupted time series designs, prospective cohort studies, mixed-method studies, and qualitative studies. Two reviewers performed study selection and data extraction using standardized forms. Disagreements were resolved through discussion or third party adjudication. Using a narrative synthesis, the body of research was mapped by design, clinical areas, strategies, and provider and patient outcomes to determine areas appropriate for a systematic review. There are a sufficiently high number of studies to conduct a more focused systematic review by care settings, study design, implementation strategies, or outcomes. A focused review could assist in determining which strategies can be recommended for enhancing EIDM knowledge, skills, and behaviours among nurses in tertiary care. © 2014 The Authors. Worldviews on Evidence-Based Nursing published by Wiley Periodicals, Inc. on behalf of Sigma Theta Tau International.

Cosmesis, patient satisfaction, and quality of life after da Vinci Single-Site cholecystectomy and multiport laparoscopic cholecystectomy: short-term results from a prospective, multicenter, randomized, controlled trial.

PubMed

Kudsi, Omar Yusef; Castellanos, Andres; Kaza, Srinivas; McCarty, Justin; Dickens, Eugene; Martin, David; Tiesenga, Frederick M; Konstantinidis, Konstantinos; Hirides, Petros; Mehendale, Shilpa; Gonzalez, Anthony

2017-08-01

Single-incision laparoscopic cholecystectomy evolved from the traditional multiport laparoscopic technique. Prior trials have demonstrated improved cosmesis with the single-incision technique. Robotic single-site surgery minimizes the technical difficulties associated with laparoscopic single-incision approach. This is the first prospective, randomized, controlled study comparing robotic single-site cholecystectomy (RSSC) and multiport laparoscopic cholecystectomy (MPLC) in terms of cosmesis and patient satisfaction. Patients with symptomatic benign gallbladder disease were randomized to RSSC or MPLC. Data included perioperative variables such as operative time, conversion and complications and cosmesis satisfaction, body image perception, quality of life using validated questionnaires, at postoperative visits of 2, 6 weeks and 3 months. One hundred thirty-six patients were randomized to RSSC (N = 83) and MPLC (N = 53) at 8 institutions. Both cohorts were dominated by higher enrollment of females (RSSC = 78%, MPLC = 92%). The RSSC and MPLC cohorts were otherwise statistically matched. Operative time was longer for RSSC (61 min vs. 44 min, P < 0.0001). There were no differences in complication rates. RSSC demonstrated a significant superiority in cosmesis satisfaction and body image perception (P value < 0.05 at every follow-up). There was no statistically significant difference in patient-reported quality of life. Multivariate analysis of female patients demonstrated significantly higher preference for RSSC over MPLC in cosmesis satisfaction and body image perception with no difference seen in overall quality of life. Results from this trial show that RSSC is associated with improved cosmesis satisfaction and body image perception without a difference in observed complication rate. The uncompromised safety and the improved cosmesis satisfaction and body image perception provided by RSSC for female patients support consideration of the robotic single-site approach. ClinicalTrials.gov identifier NCT01932216.

[Effectiveness of a ketogenic diet in children with refractory epilepsy: a systematic review].

PubMed

Araya-Quintanilla, F; Celis-Rosati, A; Rodriguez-Leiva, C; Silva-Navarro, C; Silva-Pinto, Y; Toro-Jeria, B

2016-05-16

Epilepsy is a brain disorder that affects both children and adults. From the 1920s the ketogenic diet has gained prestige as another treatment option for patients with refractory epilepsy. A summary of the evidence will be made through a systematic review of randomized clinical trials that have compared a single ketogenic diet with other diet for the management of these patients. To determine the effectiveness of the ketogenic diet in reducing episodes of seizures in patients with refractory epilepsy. The search strategy included randomized controlled trials and controlled clinical trials. Databases used were Medline, LILACS, Central and CINAHL. Six articles that met our elegibility criteria. There is limited evidence that the ketogenic diet compared to the medium-chain triglyceride diet is more effective in reducing the frequency of seizures. There is also moderate evidence that classical ketogenic diet compared to the gradual diet (2.5:1 and 3:1) is more effective in reducing seizures. There is moderate evidence that classical ketogenic diet compared to Atkins diet is more effective in reducing the frequency of seizure. The decision to apply this type of diet should also be based on costs, preferences and safety of treatment. It should also take into account the likelihood that studies have indexing problems have been left out of the review.

Controversies in the treatment of patients with STEMI and multivessel disease: is it time for PCI of all lesions?

PubMed

Ong, Peter; Sechtem, Udo

2016-06-01

Several randomized trials have suggested a benefit for multivessel PCI in patients with STEMI and multivessel disease. However, none of the studies compared multivessel PCI with a staged PCI-approach which is the current guideline recommended approach. The results of the trials may overestimate the beneficial effect of the multivessel PCI approach because the control group did not receive any ischaemia testing for evaluation of the significance of remaining lesions. Thus, unfavourable aspects of the multivessel PCI approach such as overestimation of non-culprit lesions at the time of acute coronary angiography, complications associated with PCI of the non-culprit lesion (i.e. dissection, no-reflow, acute stent thrombosis) or increased risk for contrast induced nephropathy may have gone unnoticed as the comparative management pathway was unusual and likely inferior to the guideline recommended approach. We believe that culprit lesion only PCI and staged evaluation of remaining areas of myocardial ischaemia with subsequent PCI is still preferable in patients with STEMI and multivessel disease but a randomized study comparing this approach with multivessel PCI is needed.

The use of coffee, chewing-gum and gastrograffin in the management of postoperative ileus: A review of current evidence.

PubMed

Flores-Funes, Diego; Campillo-Soto, Álvaro; Pellicer-Franco, Enrique; Aguayo-Albasini, José Luis

2016-11-01

Postoperative ileus is one of the main complications in the postoperative period. New measures appeared with the introduction of «fast-track surgery» to accelerate recovery: coffee, chewing gum and gastrograffin. We performed a summary of current evidence, reviewing articles from MEDLINE, Cochrane Database of Systematic Reviews, ISI Web of Science, and SCOPUS databases. Employed search terms were «postoperative ileus» AND («definition» OR «epidemiology» OR «risk factors» OR «Management»). We selected 44 articles: 9 systematic reviews 11 narrative reviews, 13 randomized clinical trials, 6 observational studies, and the remaining 5 scientific letters, assumptions, etc. There is little literature about this topic, studies are heterogeneous, with disparity in the results. In addition, they only focus on colorectal and gynecological surgery. New high-quality studies are needed, preferably randomized clinical trials, in order to clarify the usefulness of these measures. Copyright © 2016 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

Comparative Effectiveness of Mesalamine, Sulfasalazine, Corticosteroids, and Budesonide for the Induction of Remission in Crohn's Disease: A Bayesian Network Meta-analysis.

PubMed

Coward, Stephanie; Kuenzig, M Ellen; Hazlewood, Glen; Clement, Fiona; McBrien, Kerry; Holmes, Rebecca; Panaccione, Remo; Ghosh, Subrata; Seow, Cynthia H; Rezaie, Ali; Kaplan, Gilaad G

2017-03-01

Induction treatment of mild-to-moderate Crohn's disease is controversial. To compare the induction of remission between different doses of mesalamine, sulfasalazine, corticosteroids, and budesonide for active Crohn's disease. We identified randomized controlled trials from existing Cochrane reviews and an updated literature search in Medline, EMBASE, and CENTRAL to November 2015. We included randomized controlled trials (n = 22) in adult patients with Crohn's disease that compared budesonide, sulfasalazine, mesalamine, or corticosteroids with placebo or each other, for the induction of remission (8-17 wks). Mesalamine (above and below 2.4 g/d) and budesonide (above and below 6 mg/d) were stratified into low and high doses. Our primary outcome was remission, defined as a Crohn's Disease Activity Index score <150. A Bayesian random-effects network meta-analysis was performed on the proportion in remission. Corticosteroids (odds ratio [OR] = 3.80; 95% credible interval [CrI]: 2.48-5.66), high-dose budesonide (OR = 2.96; 95% CrI: 2.06-4.30), and high-dose mesalamine (OR = 2.29; 95% CrI: 1.58-3.33) were superior to placebo. Corticosteroids were similar to high-dose budesonide (OR = 1.21; 95% CrI: 0.84-1.76), but more effective than high-dose mesalamine (OR = 1.83; 95% CrI: 1.16-2.88). Sulfasalazine was not significantly superior to any therapy including placebo. Randomized controlled trials that use a strict definition of induction of remission and disease severity at enrollment to assess effectiveness in treating mild-to-moderate Crohn's disease are limited. Corticosteroids and high-dose budesonide were effective treatments for inducing remission in mild-to-moderate Crohn's disease. High-dose mesalamine is an option among patients preferring to avoid steroids.

Training health professionals to recruit into challenging randomized controlled trials improved confidence: the development of the QuinteT randomized controlled trial recruitment training intervention.

PubMed

Mills, Nicola; Gaunt, Daisy; Blazeby, Jane M; Elliott, Daisy; Husbands, Samantha; Holding, Peter; Rooshenas, Leila; Jepson, Marcus; Young, Bridget; Bower, Peter; Tudur Smith, Catrin; Gamble, Carrol; Donovan, Jenny L

2018-03-01

The objective of this study was to describe and evaluate a training intervention for recruiting patients to randomized controlled trials (RCTs), particularly for those anticipated to be difficult for recruitment. One of three training workshops was offered to surgeons and one to research nurses. Self-confidence in recruitment was measured through questionnaires before and up to 3 months after training; perceived impact of training on practice was assessed after. Data were analyzed using two-sample t-tests and supplemented with findings from the content analysis of free-text comments. Sixty-seven surgeons and 32 nurses attended. Self-confidence scores for all 10 questions increased after training [range of mean scores before 5.1-6.9 and after 6.9-8.2 (scale 0-10, all 95% confidence intervals are above 0 and all P-values <0.05)]. Awareness of hidden challenges of recruitment following training was high-surgeons' mean score 8.8 [standard deviation (SD), 1.2] and nurses' 8.4 (SD, 1.3) (scale 0-10); 50% (19/38) of surgeons and 40% (10/25) of nurses reported on a 4-point Likert scale that training had made "a lot" of difference to their RCT discussions. Analysis of free text revealed this was mostly in relation to how to convey equipoise, explain randomization, and manage treatment preferences. Surgeons and research nurses reported increased self-confidence in discussing RCTs with patients, a raised awareness of hidden challenges and a positive impact on recruitment practice following QuinteT RCT Recruitment Training. Training will be made more available and evaluated in relation to recruitment rates and informed consent. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Design of the Resistance and Endurance exercise After ChemoTherapy (REACT) study: a randomized controlled trial to evaluate the effectiveness and cost-effectiveness of exercise interventions after chemotherapy on physical fitness and fatigue.

PubMed

Kampshoff, Caroline S; Buffart, Laurien M; Schep, Goof; van Mechelen, Willem; Brug, Johannes; Chinapaw, Mai J M

2010-11-30

Preliminary studies suggest that physical exercise interventions can improve physical fitness, fatigue and quality of life in cancer patients after completion of chemotherapy. Additional research is needed to rigorously test the effects of exercise programmes among cancer patients and to determine optimal training intensity accordingly. The present paper presents the design of a randomized controlled trial evaluating the effectiveness and cost-effectiveness of a high intensity exercise programme compared to a low-to-moderate intensity exercise programme and a waiting list control group on physical fitness and fatigue as primary outcomes. After baseline measurements, cancer patients who completed chemotherapy are randomly assigned to either a 12-week high intensity exercise programme or a low-to-moderate intensity exercise programme. Next, patients from both groups are randomly assigned to immediate training or a waiting list (i.e. waiting list control group). After 12 weeks, patients of the waiting list control group start with the exercise programme they have been allocated to.Both interventions consist of equal bouts of resistance and endurance interval exercises with the same frequency and duration, but differ in training intensity. Additionally, patients of both exercise programmes are counselled to improve compliance and achieve and maintain an active lifestyle, tailored to their individual preferences and capabilities.Measurements will be performed at baseline (t = 0), 12 weeks after randomization (t = 1), and 64 weeks after randomization (t = 2). The primary outcome measures are cardiorespiratory fitness and muscle strength assessed by means of objective performance indicators, and self-reported fatigue. Secondary outcome measures include health-related quality of life, self-reported physical activity, daily functioning, body composition, mood and sleep disturbances, and return to work. In addition, compliance and satisfaction with the interventions will be evaluated. Potential moderation by pre- and post-illness lifestyle, health and exercise-related attitudes, beliefs and motivation will also be assessed. Finally, the cost-effectiveness of both exercise interventions will be evaluated. This randomized controlled trial will be a rigorous test of effects of exercise programmes for cancer patients after chemotherapy, aiming to contribute to evidence-based practice in cancer rehabilitation programmes. This study is registered at the Netherlands Trial Register (NTR2153).

Comparison of the latanoprost 0.005%/timolol 0.5% + brinzolamide 1% versus dorzolamide 1%/timolol 0.5% + latanoprost 0.005%: a 12-week, randomized open-label trial

PubMed Central

Nakakura, Shunsuke; Tabuchi, Hitoshi; Baba, Yukio; Maruiwa, Futoshi; Ando, Nobuko; Kanamoto, Takashi; Kiuchi, Yoshiaki

2012-01-01

Objective To compare the safety and effectiveness of fixed-combination regimes (latanoprost– timolol and brinzolamide 1% compared to dorzolamide 1%/timolol and latanoprost) in open-angle glaucoma patients after switching from a combination of three topical antiglaucoma eye drops. Methods We conducted an open, randomized 12-week multicenter prospective study. We randomly allocated 39 patients who had been treated with three antiglaucoma eye drops (prostaglandin F2α analogues plus beta-blockers and carbonic anhydrase inhibitors) into two groups. Group A (n = 20) were treated with latanoprost–timolol and brinzolamide 1% therapy and Group B (n = 16) were treated with dorzolamide 1%/timolol and latanoprost. Thirty-six patients completed all 12 weeks of this study. The major clinical parameters measured were intraocular pressure (IOP), conjunctive hyperemia, superficial punctate keratopathy and hyperpigmentation of eyelid at baseline, 4, and 12 weeks. Additionally noted were adverse events and patient preferences, measured using a questionnaire at study initiation and at 12 weeks. Results At baseline, IOPs were (Group A: 14.1 ± 2.9 mmHg, B: 14.5 ± 2.9 mmHg; P = 0.658), (Group A: 13.8 ± 2.6 mmHg, B: 14.3 ± 2.8 mmHg; P = 0.715) at 4 weeks, and (Group A: 14.1 ± 2.7 mmHg, B: 14.2 ± 2.7 mmHg; P = 0.538) at 12 weeks. Among the groups, there was no significant difference at any time point after baseline (P = 0.923, 0.951, respectively). All adverse events were not remarkably different after therapy. In regards to patient preference before and after switching therapy, 10 patients (50%) in Group A and 10 patients (63%) in Group B preferred using fixed-combination eye drop therapy. Conclusions Effectiveness and safety were maintained in both groups after switching therapy. Overall, patients generally preferred using a fixed-combination therapy. PMID:22419858

Home-based HIV testing for men preferred over clinic-based testing by pregnant women and their male partners, a nested cross-sectional study.

PubMed

Osoti, Alfred Onyango; John-Stewart, Grace; Kiarie, James Njogu; Barbra, Richardson; Kinuthia, John; Krakowiak, Daisy; Farquhar, Carey

2015-07-30

Male partner HIV testing and counseling (HTC) is associated with enhanced uptake of prevention of mother-to-child HIV transmission (PMTCT), yet male HTC during pregnancy remains low. Identifying settings preferred by pregnant women and their male partners may improve male involvement in PMTCT. Participants in a randomized clinical trial (NCT01620073) to improve male partner HTC were interviewed to determine whether the preferred male partner HTC setting was the home, antenatal care (ANC) clinic or VCT center. In this nested cross sectional study, responses were evaluated at baseline and after 6 weeks. Differences between the two time points were compared using McNemar's test and correlates of preference were determined using logistic regression. Among 300 pregnant female participants, 54% preferred home over ANC clinic testing (34.0%) or VCT center (12.0%). Among 188 male partners, 68% preferred home-based HTC to antenatal clinic (19%) or VCT (13%). Men who desired more children and women who had less than secondary education or daily income < $2 USD were more likely to prefer home-based over other settings (p < 0.05 for all comparisons). At 6 weeks, the majority of male (81%) and female (65%) participants recommended home over alternative HTC venues. Adjusting for whether or not the partner was tested during follow-up did not significantly alter preferences. Pregnant women and their male partners preferred home-based compared to clinic or VCT-center based male partner HTC. Home-based HTC during pregnancy appears acceptable and may improve male testing and involvement in PMTCT.

Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: a cluster preference randomized controlled trial.

PubMed

Rogers, Simon N; Lowe, Derek; Lowies, Cher; Yeo, Seow Tien; Allmark, Christine; Mcavery, Dominic; Humphris, Gerald M; Flavel, Robert; Semple, Cherith; Thomas, Steven J; Kanatas, Anastasios

2018-04-18

The consequences of treatment for Head and Neck cancer (HNC) patients has profound detrimental impacts such as impaired QOL, emotional distress, delayed recovery and frequent use of healthcare. The aim of this trial is to determine if the routine use of the Patients Concerns Inventory (PCI) package in review clinics during the first year following treatment can improve overall quality of life, reduce the social-emotional impact of cancer and reduce levels of distress. Furthermore, we aim to describe the economic costs and benefits of using the PCI. This will be a cluster preference randomised control trial with consultants either 'using' or 'not using' the PCI package at clinic. It will involve two centres Leeds and Liverpool. 416 eligible patients from at least 10 consultant clusters are required to show a clinically meaningful difference in the primary outcome. The primary outcome is the percentage of participants with less than good overall quality of life at the final one-year clinic as measured by the University of Washington QOL questionnaire version 4 (UWQOLv4). Secondary outcomes at one-year are the mean social-emotional subscale (UWQOLv4) score, Distress Thermometer (DT) score ≥ 4, and key health economic measures (QALY-EQ-5D-5 L; CSRI). This trial will provide knowledge on the effectiveness of a consultation intervention package based around the PCI used at routine follow-up clinics following treatment of head and neck cancer with curative intent. If this intervention is (cost) effective for patients, the next step will be to promote wider use of this approach as standard care in clinical practice. 32,382. Clinical Trials Identifier, NCT03086629 . Version 3.0, 1st July 2017.

The role of mHealth for improving medication adherence in patients with cardiovascular disease: a systematic review

PubMed Central

Gandapur, Yousuf; Kianoush, Sina; Kelli, Heval M.; Misra, Satish; Urrea, Bruno; Blaha, Michael J.; Graham, Garth; Marvel, Francoise A.; Martin, Seth S.

2016-01-01

Abstract Cardiovascular disease is a leading cause of morbidity and mortality worldwide, and a key barrier to improved outcomes is medication non-adherence. The aim of this study is to review the role of mobile health (mHealth) tools for improving medication adherence in patients with cardiovascular disease. We performed a systematic search for randomized controlled trials that primarily investigated mHealth tools for improving adherence to cardiovascular disease medications in patients with hypertension, coronary artery disease, heart failure, peripheral arterial disease, and stroke. We extracted and reviewed data on the types of mHealth tools used, preferences of patients and healthcare providers, the effect of the mHealth interventions on medication adherence, and the limitations of trials. We identified 10 completed trials matching our selection criteria, mostly with <100 participants, and ranging in duration from 1 to 18 months. mHealth tools included text messages, Bluetooth-enabled electronic pill boxes, online messaging platforms, and interactive voice calls. Patients and healthcare providers generally preferred mHealth to other interventions. All 10 studies reported that mHealth interventions improved medication adherence, though the magnitude of benefit was not consistently large and in one study was not greater than a telehealth comparator. Limitations of trials included small sample sizes, short duration of follow-up, self-reported outcomes, and insufficient assessment of unintended harms and financial implications. Current evidence suggests that mHealth tools can improve medication adherence in patients with cardiovascular diseases. However, high-quality clinical trials of sufficient size and duration are needed to move the field forward and justify use in routine care. PMID:29474713

Physicians' preferences for asthma guidelines implementation.

PubMed

Kang, Min-Koo; Kim, Byung-Keun; Kim, Tae-Wan; Kim, Sae-Hoon; Kang, Hye-Ryun; Park, Heung-Woo; Chang, Yoon-Seok; Kim, Sun-Sin; Min, Kyung-Up; Kim, You-Young; Cho, Sang-Heon

2010-10-01

Patient care based on asthma guidelines is cost-effective and leads to improved treatment outcomes. However, ineffective implementation strategies interfere with the use of these recommendations in clinical practice. This study investigated physicians' preferences for asthma guidelines, including content, supporting evidence, learning strategies, format, and placement in the clinical workplace. We obtained information through a questionnaire survey. The questionnaire was distributed to physicians attending continuing medical education courses and sent to other physicians by airmail, e-mail, and facsimile. A total of 183 physicians responded (male to female ratio, 2.3:1; mean age, 40.4±9.9 years); 89.9% of respondents were internists or pediatricians, and 51.7% were primary care physicians. Physicians preferred information that described asthma medications, classified the disease according to severity and level of control, and provided methods of evaluation/treatment/monitoring and management of acute exacerbation. The most effective strategies for encouraging the use of the guidelines were through continuing medical education and discussions with colleagues. Physicians required supporting evidence in the form of randomized controlled trials and expert consensus. They preferred that the guidelines be presented as algorithms or flow charts/flow diagrams on plastic sheets, pocket cards, or in electronic medical records. This study identified the items of the asthma guidelines preferred by physicians in Korea. Asthma guidelines with physicians' preferences would encourage their implementation in clinical practice.

On the estimation of intracluster correlation for time-to-event outcomes in cluster randomized trials.

PubMed

Kalia, Sumeet; Klar, Neil; Donner, Allan

2016-12-30

Cluster randomized trials (CRTs) involve the random assignment of intact social units rather than independent subjects to intervention groups. Time-to-event outcomes often are endpoints in CRTs. Analyses of such data need to account for the correlation among cluster members. The intracluster correlation coefficient (ICC) is used to assess the similarity among binary and continuous outcomes that belong to the same cluster. However, estimating the ICC in CRTs with time-to-event outcomes is a challenge because of the presence of censored observations. The literature suggests that the ICC may be estimated using either censoring indicators or observed event times. A simulation study explores the effect of administrative censoring on estimating the ICC. Results show that ICC estimators derived from censoring indicators or observed event times are negatively biased. Analytic work further supports these results. Observed event times are preferred to estimate the ICC under minimum frequency of administrative censoring. To our knowledge, the existing literature provides no practical guidance on the estimation of ICC when substantial amount of administrative censoring is present. The results from this study corroborate the need for further methodological research on estimating the ICC for correlated time-to-event outcomes. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Are There Scenarios When the Use of Non-Placebo-Control Groups in Experimental Trial Designs Increase Expected Value to Society?

PubMed

Uyei, Jennifer; Braithwaite, R Scott

2016-01-01

Despite the benefits of the placebo-controlled trial design, it is limited by its inability to quantify total benefits and harms. Such trials, for example, are not designed to detect an intervention's placebo or nocebo effects, which if detected could alter the benefit-to-harm balance and change a decision to adopt or reject an intervention. In this article, we explore scenarios in which alternative experimental trial designs, which differ in the type of control used, influence expected value across a range of pretest assumptions and study sample sizes. We developed a decision model to compare 3 trial designs and their implications for decision making: 2-arm placebo-controlled trial ("placebo-control"), 2-arm intervention v. do nothing trial ("null-control"), and an innovative 3-arm trial design: intervention v. do nothing v. placebo trial ("novel design"). Four scenarios were explored regarding particular attributes of a hypothetical intervention: 1) all benefits and no harm, 2) no biological effect, 3) only biological effects, and 4) surreptitious harm (no biological benefit or nocebo effect). Scenario 1: When sample sizes were very small, the null-control was preferred, but as sample sizes increased, expected value of all 3 designs converged. Scenario 2: The null-control was preferred regardless of sample size when the ratio of placebo to nocebo effect was >1; otherwise, the placebo-control was preferred. Scenario 3: When sample size was very small, the placebo-control was preferred when benefits outweighed harms, but the novel design was preferred when harms outweighed benefits. Scenario 4: The placebo-control was preferred when harms outweighed placebo benefits; otherwise, preference went to the null-control. Scenarios are hypothetical, study designs have not been tested in a real-world setting, blinding is not possible in all designs, and some may argue the novel design poses ethical concerns. We identified scenarios in which alternative experimental study designs would confer greater expected value than the placebo-controlled trial design. The likelihood and prevalence of such situations warrant further study. © The Author(s) 2015.

Mean common or mean maximum carotid intima-media thickness as primary outcome in lipid-modifying intervention studies.

PubMed

Dogan, Soner; Kastelein, Johannes Jacob Pieter; Grobbee, Diederick Egbertus; Bots, Michiel Leonardus

2011-01-01

Carotid intima-media thickness (CIMT) measurements are used as a disease outcome in randomized controlled trials that assess the effects of lipid-modifying treatment. It is unclear whether common CIMT or mean maximum CIMT should be used as the primary outcome. We directly compared both measurements using aspects that are of great importance in deciding which is most favorable for use in clinical trials. A literature search was performed (PUBMED, up to March 31, 2008). Fifteen trials with lipid-modifying treatment were identified that had information on both outcome measures. Common CIMT and mean maximum CIMT were compared on reproducibility, strength of relation with LDL and HDL cholesterol and congruency of their results (harm/neutral/beneficial) with data from event trials. Findings showed that the reported reproducibility was high for both measurements, although a direct comparison was not possible. The relationship between the achieved LDL-C and HDL-C levels with CIMT progression was modest and showed no difference in magnitude between CIMT measurements. CIMT progression rates differed across carotid segments with the highest progression rates observed in the bifurcation segment. Treatment effects differed across carotid segments without a clear preference pattern. Trials using mean maximum CIMT progression more often (12 out of 15 studies) paralleled the findings of event trials in contrast to the mean common CIMT (11 out of 15 studies), a difference not reaching statistical significance. Based on the literature, with equal results for reproducibility (assumed), lipid relationship and congruency with event findings, but with treatment effects that differ across carotid segments that can not be predicted, the mean maximum CIMT as the primary outcome may be preferred in trials on the impact of lipid-modifying interventions. One advantage is that information on mean common CIMT can generally be obtained easily in protocols assessing mean maximum CIMT, but not the other way around.

SESOTHO trial ("Switch Either near Suppression Or THOusand") - switch to second-line versus WHO-guided standard of care for unsuppressed patients on first-line ART with viremia below 1000 copies/mL: protocol of a multicenter, parallel-group, open-label, randomized clinical trial in Lesotho, Southern Africa.

PubMed

Amstutz, Alain; Nsakala, Bienvenu Lengo; Vanobberghen, Fiona; Muhairwe, Josephine; Glass, Tracy Renée; Achieng, Beatrice; Sepeka, Mamorena; Tlali, Katleho; Sao, Lebohang; Thin, Kyaw; Klimkait, Thomas; Battegay, Manuel; Labhardt, Niklaus Daniel

2018-02-12

The World Health Organization (WHO) recommends viral load (VL) measurement as the preferred monitoring strategy for HIV-infected individuals on antiretroviral therapy (ART) in resource-limited settings. The new WHO guidelines 2016 continue to define virologic failure as two consecutive VL ≥1000 copies/mL (at least 3 months apart) despite good adherence, triggering switch to second-line therapy. However, the threshold of 1000 copies/mL for defining virologic failure is based on low-quality evidence. Observational studies have shown that individuals with low-level viremia (measurable but below 1000 copies/mL) are at increased risk for accumulation of resistance mutations and subsequent virologic failure. The SESOTHO trial assesses a lower threshold for switch to second-line ART in patients with sustained unsuppressed VL. In this multicenter, parallel-group, open-label, randomized controlled trial conducted in Lesotho, patients on first-line ART with two consecutive unsuppressed VL measurements ≥100 copies/mL, where the second VL is between 100 and 999 copies/mL, will either be switched to second-line ART immediately (intervention group) or not be switched (standard of care, according to WHO guidelines). The primary endpoint is viral resuppression (VL < 50 copies/mL) 9 months after randomization. We will enrol 80 patients, giving us 90% power to detect a difference of 35% in viral resuppression between the groups (assuming two-sided 5% alpha error). For our primary analysis, we will use a modified intention-to-treat set, with those lost to care, death, or crossed over considered failure to resuppress, and using logistic regression models adjusted for the prespecified stratification variables. The SESOTHO trial challenges the current WHO guidelines, assessing an alternative, lower VL threshold for patients with unsuppressed VL on first-line ART. This trial will provide data to inform future WHO guidelines on VL thresholds to recommend switch to second-line ART. ClinicalTrials.gov ( NCT03088241 ), registered May 05, 2017.

A New Method of Random Environmental Walking for Assessing Behavioral Preferences for Different Lighting Applications

PubMed Central

Patching, Geoffrey R.; Rahm, Johan; Jansson, Märit; Johansson, Maria

2017-01-01

Accurate assessment of people’s preferences for different outdoor lighting applications is increasingly considered important in the development of new urban environments. Here a new method of random environmental walking is proposed to complement current methods of assessing urban lighting applications, such as self-report questionnaires. The procedure involves participants repeatedly walking between different lighting applications by random selection of a lighting application and preferred choice or by random selection of a lighting application alone. In this manner, participants are exposed to all lighting applications of interest more than once and participants’ preferences for the different lighting applications are reflected in the number of times they walk to each lighting application. On the basis of an initial simulation study, to explore the feasibility of this approach, a comprehensive field test was undertaken. The field test included random environmental walking and collection of participants’ subjective ratings of perceived pleasantness (PP), perceived quality, perceived strength, and perceived flicker of four lighting applications. The results indicate that random environmental walking can reveal participants’ preferences for different lighting applications that, in the present study, conformed to participants’ ratings of PP and perceived quality of the lighting applications. As a complement to subjectively stated environmental preferences, random environmental walking has the potential to expose behavioral preferences for different lighting applications. PMID:28337163

Job retention vocational rehabilitation for employed people with inflammatory arthritis (WORK-IA): a feasibility randomized controlled trial.

PubMed

Hammond, Alison; O'Brien, Rachel; Woodbridge, Sarah; Bradshaw, Lucy; Prior, Yeliz; Radford, Kate; Culley, June; Whitham, Diane; Ruth Pulikottil-Jacob

2017-07-21

Inflammatory arthritis leads to work disability, absenteeism and presenteeism (i.e. at-work productivity loss) at high cost to individuals, employers and society. A trial of job retention vocational rehabilitation (VR) in the United States identified this helped people keep working. The effectiveness of this VR in countries with different socioeconomic policies and conditions, and its impact on absenteeism, presenteeism and health, are unknown. This feasibility study tested the acceptability of this VR, modified for the United Kingdom, compared to written advice about managing work problems. To help plan a randomized controlled trial, we tested screening, recruitment, intervention delivery, response rates, applicability of the control intervention and identified the relevant primary outcome. A feasibility randomized controlled trial with rheumatoid, psoriatic or inflammatory arthritis patients randomized to receive either job retention VR or written information only (the WORK-IA trial). Following three days VR training, rheumatology occupational therapists provided individualised VR on a one to one basis. VR included work assessment, activity diaries and action planning, and (as applicable) arthritis self-management in the workplace, ergonomics, fatigue and stress management, orthoses, employment rights and support services, assistive technology, work modifications, psychological and disclosure support, workplace visits and employer liaison. Fifty five (10%) people were recruited from 539 screened. Follow-up response rates were acceptable at 80%. VR was delivered with fidelity. VR was more acceptable than written advice only (7.8 versus 6.7). VR took on average 4 h at a cost of £135 per person. Outcome assessment indicated VR was better than written advice in reducing presenteeism (Work Limitations Questionnaire (WLQ) change score mean: VR = -12.4 (SD 13.2); control = -2.5 (SD 15.9), absenteeism, perceived risk of job loss and improving pain and health status, indicating proof of concept. The preferred primary outcome measure was the WLQ, a presenteeism measure. This brief job retention VR is a credible and acceptable intervention for people with inflammatory arthritis with concerns about continuing to work due to arthritis. ISRCTN 76777720 . Registered 21.9.12.

Shared decision making for prostate cancer screening: the results of a combined analysis of two practice-based randomized controlled trials.

PubMed

Sheridan, Stacey L; Golin, Carol; Bunton, Audrina; Lykes, John B; Schwartz, Bob; McCormack, Lauren; Driscoll, David; Bangdiwala, Shrikant I; Harris, Russell P

2012-11-13

Professional societies recommend shared decision making (SDM) for prostate cancer screening, however, most efforts have promoted informed rather than shared decision making. The objective of this study is to 1) examine the effects of a prostate cancer screening intervention to promote SDM and 2) determine whether framing prostate information in the context of other clearly beneficial men's health services affects decisions. We conducted two separate randomized controlled trials of the same prostate cancer intervention (with or without additional information on more clearly beneficial men's health services). For each trial, we enrolled a convenience sample of 2 internal medicine practices, and their interested physicians and male patients with no prior history of prostate cancer (for a total of 4 practices, 28 physicians, and 128 men across trials). Within each practice site, we randomized men to either 1) a video-based decision aid and researcher-led coaching session or 2) a highway safety video. Physicians at each site received a 1-hour educational session on prostate cancer and SDM. To assess intervention effects, we measured key components of SDM, intent to be screened, and actual screening. After finding that results did not vary by trial, we combined data across sites, adjusting for the random effects of both practice and physician. Compared to an attention control, our prostate cancer screening intervention increased men's perceptions that screening is a decision (absolute difference +41%; 95% CI 25 to 57%) and men's knowledge about prostate cancer screening (absolute difference +34%; 95% CI 19% to 50%), but had no effect on men's self-reported participation in shared decisions or their participation at their preferred level. Overall, the intervention decreased screening intent (absolute difference -34%; 95% CI -50% to -18%) and actual screening rates (absolute difference -22%; 95% CI -38 to -7%) with no difference in effect by frame. SDM interventions can increase men's knowledge, alter their perceptions of prostate cancer screening, and reduce actual screening. However, they may not guarantee an increase in shared decisions. #NCT00630188.

Random preferences towards bioenergy environmental externalities: a case study of woody biomass based electricity in the Southern United States

Treesearch

Andres Susaeta; Pankaj Lal; Janaki Alavalapati; Evan Mercer

2011-01-01

This paper contrasts alternate methodological approaches of investigating public preferences, the random parameter logit (RPL) where tastes and preferences of respondents are assumed to be heterogeneous and the conditional logit (CL) approach where tastes and preferences remain fixed for individuals. We conducted a choice experiment to assess preferences for woody...

How We Choose One over Another: Predicting Trial-by-Trial Preference Decision

PubMed Central

Bhushan, Vidya; Saha, Goutam; Lindsen, Job; Shimojo, Shinsuke; Bhattacharya, Joydeep

2012-01-01

Preference formation is a complex problem as it is subjective, involves emotion, is led by implicit processes, and changes depending on the context even within the same individual. Thus, scientific attempts to predict preference are challenging, yet quite important for basic understanding of human decision making mechanisms, but prediction in a group-average sense has only a limited significance. In this study, we predicted preferential decisions on a trial by trial basis based on brain responses occurring before the individuals made their decisions explicit. Participants made a binary preference decision of approachability based on faces while their electrophysiological responses were recorded. An artificial neural network based pattern-classifier was used with time-frequency resolved patterns of a functional connectivity measure as features for the classifier. We were able to predict preference decisions with a mean accuracy of 74.3±2.79% at participant-independent level and of 91.4±3.8% at participant-dependent level. Further, we revealed a causal role of the first impression on final decision and demonstrated the temporal trajectory of preference decision formation. PMID:22912859

Otitis media with effusion after radiotherapy of the head and neck: a systematic review.

PubMed

Christensen, J G; Wessel, I; Gothelf, A B; Homøe, P

2018-04-26

Otitis media (OM) and associated hearing problems may be side effects to radiotherapy of the head and neck region and affect patient quality of life. The condition is associated with the tumor location. To perform a systematic review concerning the present knowledge of the risk of OM after radiotherapy of the head and neck. A comprehensive search of PubMed and Embase was carried out between 1 October 2015 and 6 February 2017. The search strategy followed the PRISMA guideline for systematic reviews. Of 597 articles 11 fulfilled the inclusion criteria. Seven were retrospective and four prospective. There were no randomized controlled trials. Eight studies concerned nasopharyngeal cancer. One study concerned cancer of the parotid gland and two studies concerned other locations of head and neck cancer. Meta-analysis could not be done due to heterogeneity between the studies. The incidence of OM varied considerably (range 8-29%). The incidence of OM is high after radiotherapy of cancer of the upper head and neck area and the Eustachian tube (ET) irradiation dosage seems associated with development of OM, but the literature is poor. Research is needed to designate patients at risk of developing OM after radiotherapy. Preferably through analysis of dosage relationships between the ET and middle ear, and development of OM. Reporting of OM should be per ear and follow standardized protocols of middle ear assessment before and after radiotherapy. Furthermore, there is a need to find new ways to prevent and treat radiation-induced OME, preferably through randomized controlled trials.

Pragmatic Randomized Trials Without Standard Informed Consent?: A National Survey.

PubMed

Nayak, Rahul K; Wendler, David; Miller, Franklin G; Kim, Scott Y H

2015-09-01

Significant debate surrounds the issue of whether written consent is necessary for pragmatic randomized, controlled trials (RCTs) with low risk. To assess the U.S. public's views on alternatives to written consent for low-risk pragmatic RCTs. National experimental survey (2 × 2 factorial design) examining support for written consent versus general notification or verbal consent in 2 research scenarios. Web-based survey conducted in December 2014. 2130 U.S. adults sampled from a nationally representative, probability-based online panel (response rate, 64.0%). Respondent's recommendation to an ethics review board and personal preference as a potential participant on how to obtain consent or notification in the 2 research scenarios. Most respondents in each of the 4 groups (range, 60.3% to 71.5%) recommended written informed consent, and personal preferences were generally in accord with that advice. Most (78.9%) believed that the pragmatic RCTs did not pose additional risks, but 62.5% of these respondents would still recommend written consent. In contrast, a substantial minority in all groups (28.5% to 39.7%) recommended the alternative option (general notification or verbal consent) over written consent. Framing effects could have affected respondents' attitudes, and nonrespondents may have differed in levels of trust toward research or health care institutions. Most of the public favored written informed consent over the most widely advocated alternatives for low-risk pragmatic RCTs; however, a substantial minority favored general notification or verbal consent. Time-sharing Experiments for the Social Sciences and Intramural Research Program of the National Institutes of Health Clinical Center.

Surrogate Endpoints in Second-Line Trials of Targeted Agents in Metastatic Colorectal Cancer: A Literature-Based Systematic Review and Meta-Analysis.

PubMed

Cremolini, Chiara; Antoniotti, Carlotta; Pietrantonio, Filippo; Berenato, Rosa; Tampellini, Marco; Baratelli, Chiara; Salvatore, Lisa; Marmorino, Federica; Borelli, Beatrice; Nichetti, Federico; Bironzo, Paolo; Sonetto, Cristina; Bartolomeo, Maria Di; Braud, Filippo de; Loupakis, Fotios; Falcone, Alfredo; Di Maio, M

2017-07-01

The purpose of this study was to evaluate progression-free survival (PFS) and objective response rate (ORR) as surrogate endpoints of overall survival (OS) in modern clinical trials investigating the efficacy of targeted agents in the second-line treatment of metastatic colorectal cancer (mCRC). A systematic search of literature pertaining to randomized phase II and III trials evaluating targeted agents as second-line treatments for mCRC was performed. The strength of the correlation between both PFS and ORR and OS was assessed based on the Pearson's correlation coefficient (R) and the coefficient of determination (R 2 ). Twenty trials, including a total of 7,571 patients, met the search criteria. The median duration of post-progression survival (PPS) was 7.6 months. The median differences between experimental and control arms were 0.65 months (range, -2.4 to 3.4) for the median PFS and 0.7 months (range, -5.8 to 3.9) for the median OS. PFS and ORR showed moderate (R=0.734, R 2 =0.539, p < 0.001) and poor correlation (R=0.169, R 2 =0.029, p=0.476) with OS, respectively. No differences between anti-angiogenic agents and other drugs were evident. Targeted agents investigated in the second-line treatment of mCRC provided minimal PFS gains translating into modest OS improvements. Considering both the moderate correlation between PFS and OS and the short duration of PPS, the OS should remain the preferred primary endpoint for randomized clinical trials in the second-line treatment of mCRC.

A Bayesian Analysis of a Randomized Clinical Trial Comparing Antimetabolite Therapies for Non-Infectious Uveitis.

PubMed

Browne, Erica N; Rathinam, Sivakumar R; Kanakath, Anuradha; Thundikandy, Radhika; Babu, Manohar; Lietman, Thomas M; Acharya, Nisha R

2017-02-01

To conduct a Bayesian analysis of a randomized clinical trial (RCT) for non-infectious uveitis using expert opinion as a subjective prior belief. A RCT was conducted to determine which antimetabolite, methotrexate or mycophenolate mofetil, is more effective as an initial corticosteroid-sparing agent for the treatment of intermediate, posterior, and pan-uveitis. Before the release of trial results, expert opinion on the relative effectiveness of these two medications was collected via online survey. Members of the American Uveitis Society executive committee were invited to provide an estimate for the relative decrease in efficacy with a 95% credible interval (CrI). A prior probability distribution was created from experts' estimates. A Bayesian analysis was performed using the constructed expert prior probability distribution and the trial's primary outcome. A total of 11 of the 12 invited uveitis specialists provided estimates. Eight of 11 experts (73%) believed mycophenolate mofetil is more effective. The group prior belief was that the odds of treatment success for patients taking mycophenolate mofetil were 1.4-fold the odds of those taking methotrexate (95% CrI 0.03-45.0). The odds of treatment success with mycophenolate mofetil compared to methotrexate was 0.4 from the RCT (95% confidence interval 0.1-1.2) and 0.7 (95% CrI 0.2-1.7) from the Bayesian analysis. A Bayesian analysis combining expert belief with the trial's result did not indicate preference for one drug. However, the wide credible interval leaves open the possibility of a substantial treatment effect. This suggests clinical equipoise necessary to allow a larger, more definitive RCT.

Exploring the transparency mechanism and evaluating the effect of public reporting on prescription: a protocol for a cluster randomized controlled trial.

PubMed

Du, Xin; Wang, Dan; Wang, Xuan; Yang, Shiru; Zhang, Xinping

2015-03-21

The public reporting of health outcomes has become one of the most popular topics and is accepted as a quality improvement method in the healthcare field. However, little research has been conducted on the transparency mechanism, and results are mixed with regard to the evaluation of the effect of public reporting on quality improvement. The objectives of this trial are to investigate the transparency mechanism and to evaluate the effect of public reporting on prescription at the level of individual participants. This study involves a cluster randomized controlled trial conducted in 20 primary-care facilities (clusters). Eligible clusters are those facilities with excellent hospital information systems and that have agreed to participate in the trial. The 20 clusters are matched into 10 pairs according to Technique for Order Preference by Similarity to Ideal Solution score. As the unit of randomization, each pair of facilities is assigned at random to a control or an intervention group through coin flipping. Prescribed ranking information is publicly reported in the intervention group. The public materials include the posters of individuals and of facilities, the ranking lists of general practitioners, and brochures of patients, which are updated monthly. The intervention began on 13th November 2013 and lasted for one year. Specifically, participants are surveyed at five points in time (baseline, quarterly following the intervention) through questionnaires, interviews, and observations. These participants include an average of 600 patients, 300 general practitioners, 15 directors, and 6 health bureau administrators. The primary outcomes are the transparency mechanism model and the changes in medicine-prescribe. Subsequently, the modifications in the transparency mechanism constructs are evaluated. The outcomes are measured at the individual participant level, and the professional who analyzes the data is blind to the randomization status. This study protocol outlines a design that aims to examine the transparency mechanism and to evaluate the effect of public reporting on prescription. The research design is significant in the field of public policy. Furthermore, this study intends to fill the gap of the investigation of the transparency mechanism and the evaluation of public reporting on prescription.

Cultural Beliefs and Mental Health Treatment Preferences of Ethnically Diverse Older Adult Consumers in Primary Care

PubMed Central

Jimenez, Daniel E.; Bartels, Stephen J.; Cardenas, Veronica; Daliwal, Sanam S.; Alegría, Margarita

2011-01-01

Background Beliefs concerning the causes of mental illness may help explain why there are significant disparities in the rates of formal mental health service use among racial/ethnic minority elderly as compared with their Caucasian counterparts. This study applies the Cultural Influences on Mental Health framework to identify the relationship between race/ethnicity and differences in: (1) beliefs on the cause of mental illness; (2) preferences for type of treatment; and (3) provider characteristics. Method Analyses were conducted using baseline data collected from participants who completed the Cultural Attitudes toward Healthcare and Mental Illness Questionnaire, developed for the PRISM-E (Primary Care Research in Substance Abuse and Mental Health for the Elderly) study, a multi-site randomized trial for older adults (65+) with depression, anxiety, or at-risk alcohol consumption. The final sample consisted of 1257 non-Latino Whites, 536 African-Americans, 112 Asian-Americans, and 303 Latinos. Results African-Americans, Asian-Americans, and Latinos had differing beliefs regarding the causes of mental illness when compared to Non-Latino Whites. Race/ethnicity was also associated with determining who makes healthcare decisions, treatment preferences, and preferred characteristics of healthcare providers. Conclusions This study highlights the association between race/ethnicity and health beliefs, treatment preferences, healthcare decisions, and consumers' preferred characteristics of healthcare providers. Accommodating the values and preferences of individuals can be helpful in engaging racial/ethnic minority patients in mental health services. PMID:21992942

An Economic Evaluation of a Video- and Text-Based Computer-Tailored Intervention for Smoking Cessation: A Cost-Effectiveness and Cost-Utility Analysis of a Randomized Controlled Trial

PubMed Central

Stanczyk, Nicola E.; Smit, Eline S.; Schulz, Daniela N.; de Vries, Hein; Bolman, Catherine; Muris, Jean W. M.; Evers, Silvia M. A. A.

2014-01-01

Background Although evidence exists for the effectiveness of web-based smoking cessation interventions, information about the cost-effectiveness of these interventions is limited. Objective The study investigated the cost-effectiveness and cost-utility of two web-based computer-tailored (CT) smoking cessation interventions (video- vs. text-based CT) compared to a control condition that received general text-based advice. Methods In a randomized controlled trial, respondents were allocated to the video-based condition (N = 670), the text-based condition (N = 708) or the control condition (N = 721). Societal costs, smoking status, and quality-adjusted life years (QALYs; EQ-5D-3L) were assessed at baseline, six-and twelve-month follow-up. The incremental costs per abstinent respondent and per QALYs gained were calculated. To account for uncertainty, bootstrapping techniques and sensitivity analyses were carried out. Results No significant differences were found in the three conditions regarding demographics, baseline values of outcomes and societal costs over the three months prior to baseline. Analyses using prolonged abstinence as outcome measure indicated that from a willingness to pay of €1,500, the video-based intervention was likely to be the most cost-effective treatment, whereas from a willingness to pay of €50,400, the text-based intervention was likely to be the most cost-effective. With regard to cost-utilities, when quality of life was used as outcome measure, the control condition had the highest probability of being the most preferable treatment. Sensitivity analyses yielded comparable results. Conclusion The video-based CT smoking cessation intervention was the most cost-effective treatment for smoking abstinence after twelve months, varying the willingness to pay per abstinent respondent from €0 up to €80,000. With regard to cost-utility, the control condition seemed to be the most preferable treatment. Probably, more time will be required to assess changes in quality of life. Future studies with longer follow-up periods are needed to investigate whether cost-utility results regarding quality of life may change in the long run. Trial Registration Nederlands Trial Register NTR3102 PMID:25310007

Comparison of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers on cardiovascular outcomes in hypertensive patients with type 2 diabetes mellitus: A PRISMA-compliant systematic review and meta-analysis.

PubMed

Lv, Xiaodan; Zhang, Yingshi; Niu, Yixuan; Song, Qi; Zhao, Qingchun

2018-04-01

Previous studies seem to show different effects of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin-receptor blockers (ARBs) on cardiovascular (CV) events in hypertensive patients with type 2 diabetes mellitus (T2DM). Our objective was to analyze which are preferable on the incidence of all-cause mortality, CV death, and major CV events in hypertensive patients with T2DM. PubMed, MEDLINE, and EMBASE were searched for randomized controlled trials (RCTs) published up to June 2016 with ACEI or ARBs as the intervention for hypertensive patients with T2DM. The primary end points were all-cause mortality and CV death. The secondary end points were myocardial infarction (MI), stroke, heart failure (HF), and CV events. Two investigators extracted the information independently. Data were pooled using a fixed-effects model or a random-effects model if significant heterogeneity was present. A total of 13 trials were included for analysis, 5 ACEI trials (24,976 patients) and 8 ARB trials (22,032 patients) followed for a mean of 3.8 years. Treatment with ACEI was associated with significantly reduction in all-cause mortality [odds ratio (OR) 0.87; 95% confidence interval (95% CI), 0.80-0.94], CV death (OR 0.81; 95% CI, 0.68-0.98), and other CV outcomes such as MI (0R 0.77; 95% CI, 0.66-0.90), stroke (OR 0.88; 95% CI, 0.78-0.99), HF (OR 0.65; 95% CI, 0.47-0.90), and CV events (OR 0.83; 95% CI, 0.73-0.95), whereas ARBs therapy had no significant reduction in the results of many primary and secondary outcomes. This meta-analysis suggests that treatment with ACEI showed a significant CV protection for all-cause mortality, CV death, and major CV events, whereas ARBs had no benefits on these outcomes except MI. In consideration of high mortality and morbidity, ACEI was preferable than ARBs on patients with hypertension and T2DM.

Anaesthesiological strategies in elective craniotomy: randomized, equivalence, open trial--the NeuroMorfeo trial.

PubMed

Citerio, Giuseppe; Franzosi, Maria Grazia; Latini, Roberto; Masson, Serge; Barlera, Simona; Guzzetti, Stefano; Pesenti, Antonio

2009-04-06

Many studies have attempted to determine the "best" anaesthetic technique for neurosurgical procedures in patients without intracranial hypertension. So far, no study comparing intravenous (IA) with volatile-based neuroanaesthesia (VA) has been able to demonstrate major outcome differences nor a superiority of one of the two strategies in patients undergoing elective supratentorial neurosurgery. Therefore, current practice varies and includes the use of either volatile or intravenous anaesthetics in addition to narcotics. Actually the choice of the anaesthesiological strategy depends only on the anaesthetists' preferences or institutional policies. This trial, named NeuroMorfeo, aims to assess the equivalence between volatile and intravenous anaesthetics for neurosurgical procedures. NeuroMorfeo is a multicenter, randomized, open label, controlled trial, based on an equivalence design. Patients aged between 18 and 75 years, scheduled for elective craniotomy for supratentorial lesion without signs of intracranial hypertension, in good physical state (ASA I-III) and Glasgow Coma Scale (GCS) equal to 15, are randomly assigned to one of three anaesthesiological strategies (two VA arms, sevoflurane + fentanyl or sevoflurane + remifentanil, and one IA, propofol + remifentanil). The equivalence between intravenous and volatile-based neuroanaesthesia will be evaluated by comparing the intervals required to reach, after anaesthesia discontinuation, a modified Aldrete score > or = 9 (primary end-point). Two statistical comparisons have been planned: 1) sevoflurane + fentanyl vs. propofol + remifentanil; 2) sevoflurane + remifentanil vs. propofol + remifentanil. Secondary end-points include: an assessment of neurovegetative stress based on (a) measurement of urinary catecholamines and plasma and urinary cortisol and (b) estimate of sympathetic/parasympathetic balance by power spectrum analyses of electrocardiographic tracings recorded during anaesthesia; intraoperative adverse events; evaluation of surgical field; postoperative adverse events; patient's satisfaction and analysis of costs. 411 patients will be recruited in 14 Italian centers during an 18-month period. We presented the development phase of this anaesthesiological on-going trial. The recruitment started December 4th, 2007 and up to 4th, December 2008, 314 patients have been enrolled.

Physical and psychologic effects of aromatherapy inhalation on pregnant women: a randomized controlled trial.

PubMed

Igarashi, Toshiko

2013-10-01

Stress reduction care is important for pregnant women to decrease obstetric complications and children's health problems after birth. The aim of this study is to clarify the physical and psychologic effects of inhalation aromatherapy on pregnant women. Essential oils with high linalool and linalyl acetate content that may be used during pregnancy were selected and among these, and the one preferred by the participant was used. This was a prospective, randomized, controlled trial. This trial was performed at a gynecology outpatient department in a hospital in Kyoto, Japan. The study included pregnant women in week 28 of a single pregnancy with a normal course. Participants were randomly assigned into an aromatherapy group and a control group. They were seated in the resting, seated position for 10 minutes. During the latter 5 minutes of each 10-minute session, aromatherapy inhalation was performed for the aromatherapy group. Before and after the intervention, the Profile of Mood States (POMS) was measured. During the trial, the heart-rate fluctuations were measured for the autonomic nervous system regulation. A total of 13 pregnant women participated in the trial. Seven (7) participants were assigned to the aromatherapy group and 6 participants to the control group. The results of the POMS were such that based on an intragroup comparison, significant differences were observed in the Tension-Anxiety score (p<0.05) and the Anger-Hostility score (p<0.05), and the respective improvements observed were due to aromatherapy. The results of the autonomic nervous system regulation were such that based on an intragroup comparison within the aromatherapy group, the parasympathetic nerve activity increased significantly (p<0.05). Aromatherapy inhalation using essential oils containing linalyl acetate and linalool was found to be effective for the POMS and parasympathetic nerve activity, based on an intragroup comparison. However, based on a comparison between the groups, no substantial difference was observed; hence, further study is necessary in the future.

Sex Differences in Risk Preference and c-Fos Expression in Paraventricular Thalamic Nucleus of Rats During Gambling Task

PubMed Central

Ishii, Hironori; Onodera, Mariko; Ohara, Shinya; Tsutsui, Ken-Ichiro; Iijima, Toshio

2018-01-01

Different biological requirements between males and females may cause sex differences in decision preference when choosing between taking a risk to get a higher gain or taking a lower but sure gain. Several studies have tested this assumption in rats, however the conclusion remains controversial because the previous real-world like gambling tasks contained a learning component to track a global payoff of probabilistic outcome in addition to risk preference. Therefore, we modified a simple gambling task allowing us to exclude such learning effect, and investigated the sex difference in risk preference of rats and its neural basis. The task required water deprived rats to choose between a risky option which provided four drops of water or no reward at a 50% random chance vs. a sure option which provided predictable amount x (x = 1, 2, 3, 4). The amount and the risk were explicitly instructed so that different choice conditions could be tested trial by trial without re-learning of reward contingency. Although both sexes correctly chose the sure option with the same level of accuracy when the sure option provided the best offer (x = 4), they exhibited different choice performances when two options had the same expected value (x = 2). Males and females both preferred to take risky choices than sure choices (risk seeking), but males were more risk seeking than females. Outcome-history analysis of their choice pattern revealed that females reduced their risk preference after losing risky choices, whereas males did not. Rather, as losses continued, reaction time for subsequent risky choices got shorter in males. Given that significant sex difference features mainly emerged after negative experiences, male and female rats may evaluate an unsuccessful outcome of their decision in different manners. Furthermore, c-Fos expression in the paraventricular nucleus of the thalamus (PV) was higher in the gambling task than for the control task in males while c-fos levels did not differ in females. The present study provides a clear evidence of sex differences in risk preference in rats and suggests that the PV is a candidate region contributing to sex differences in risky decision making. PMID:29692713

Beyond the treatment effect: Evaluating the effects of patient preferences in randomised trials.

PubMed

Walter, S D; Turner, R; Macaskill, P; McCaffery, K J; Irwig, L

2017-02-01

The treatments under comparison in a randomised trial should ideally have equal value and acceptability - a position of equipoise - to study participants. However, it is unlikely that true equipoise exists in practice, because at least some participants may have preferences for one treatment or the other, for a variety of reasons. These preferences may be related to study outcomes, and hence affect the estimation of the treatment effect. Furthermore, the effects of preferences can sometimes be substantial, and may even be larger than the direct effect of treatment. Preference effects are of interest in their own right, but they cannot be assessed in the standard parallel group design for a randomised trial. In this paper, we describe a model to represent the impact of preferences on trial outcomes, in addition to the usual treatment effect. In particular, we describe how outcomes might differ between participants who would choose one treatment or the other, if they were free to do so. Additionally, we investigate the difference in outcomes depending on whether or not a participant receives his or her preferred treatment, which we characterise through a so-called preference effect. We then discuss several study designs that have been proposed to measure and exploit data on preferences, and which constitute alternatives to the conventional parallel group design. Based on the model framework, we determine which of the various preference effects can or cannot be estimated with each design. We also illustrate these ideas with some examples of preference designs from the literature.

Which online format is most effective for assisting Baby Boomers to complete advance directives? A randomised controlled trial of email prompting versus online education module.

PubMed

Bradley, Sandra L; Tieman, Jennifer J; Woodman, Richard J; Phillips, Paddy A

2017-08-29

Completion of Advance Directives (ADs), being financial and healthcare proxy or instructional documents, is relatively uncommon in Australia. Efforts to increase completion rates include online education and prompting which past literature suggests may be effective. The aim of this randomized controlled trial was to assess computer-based online AD information and email prompting for facilitating completion of ADs by Australian Baby Boomers (b.1946-1965) as well as factors which may impede or assist completion of these documents by this generation when using the online environment. Two hundred eighty-two men and women aged 49-68 years at the time of the trial were randomly assigned to one of 3 intervention groups: education module only; email prompt only; email prompt and education module; and a control group with no education module and no email prompt. The randomized controlled trial was undertaken in participants' location of choice. Randomization and allocation to trial group were carried out by a central computer system. The primary analysis was based on a final total of 189 participants who completed the trial (n = 52 education module only; n = 44 email prompt only; n = 46 email prompt and education module; and n = 47 control). The primary outcome was the number of individuals in any group completing any of the 4 legal ADs in South Australia within 12 months or less from entry into the trial. Frequency analysis was conducted on secondary outcomes such as reasons for non-completion. Mean follow-up post-intervention at 12 months showed that 7% of overall participants completed one or more of the 4 legal ADs but without significant difference between groups (delta = 1%, p = .48 Prompt/Non-Prompt groups, delta = 5%, p = .44 education/non-education groups). Reasons offered for non-completion were too busy (26%) and/or it wasn't the right time (21%). Our results suggest that neither email prompting nor provision of additional educational material online were sufficient to significantly impact AD completion rates for this generational cohort. Research with this cohort over longer periods of time exploring online preferences for engagement with ADs as they age may provide better insight into using this environment for ADs with this group. Australian New Zealand Clinical Trials Registry ACTRN12616000425493 .

Increasing vegetable intake in Mexican-American youth: a randomized controlled trial.

PubMed

Johnston, Craig A; Palcic, Jennette L; Tyler, Chermaine; Stansberry, Sandra; Reeves, Rebecca S; Foreyt, John P

2011-05-01

Despite the health benefits, vegetable intake in youth remains below recommended levels. The purpose of our study was to compare two methods for increasing vegetable consumption. It was hypothesized that participants randomized to both the exposure-only and the pairing condition would increase their vegetable consumption and increase the variety of vegetables consumed. A total of 78 Mexican-American middle school-aged children from a charter school in Houston, TX, were randomized to a pairing condition (n=40) or an exposure-only condition (n=38) during the Spring 2009 semester. Children in the pairing condition were provided a preferred taste (peanut butter) paired with vegetables weekly at school during a nutrition class for 4 months. Children in the exposure-only condition received vegetables weekly during a nutrition class that covered the same material as the pairing condition. After 4 months, the pairing condition participants demonstrated significant increases in vegetable consumption (F=13.40, P<0.001) as well as variety of vegetables eaten (F=13.69, P<0.001) when compared to those in the exposure-only condition. The findings of this study suggest that the pairing of vegetables with a preferred taste, such as peanut butter, may be an effective technique in increasing consumption, especially in children who report being resistant to eating vegetables. Copyright © 2011 American Dietetic Association. Published by Elsevier Inc. All rights reserved.

Single-implant overdentures retained by the Novaloc attachment system: study protocol for a mixed-methods randomized cross-over trial.

PubMed

de Souza, Raphael F; Bedos, Christophe; Esfandiari, Shahrokh; Makhoul, Nicholas M; Dagdeviren, Didem; Abi Nader, Samer; Jabbar, Areej A; Feine, Jocelyne S

2018-04-23

Overdentures retained by a single implant in the midline have arisen as a minimal implant treatment for edentulous mandibles. The success of this treatment depends on the performance of a single stud attachment that is susceptible to wear-related retention loss. Recently developed biomaterials used in attachments may result in better performance of the overdentures, offering minimal retention loss and greater patient satisfaction. These biomaterials include resistant polymeric matrixes and amorphous diamond-like carbon applied on metallic components. The objective of this explanatory mixed-methods study is to compare Novaloc, a novel attachment system with such characteristics, to a traditional alternative for single implants in the mandible of edentate elderly patients. We will carry out a randomized cross-over clinical trial comparing Novaloc attachments to Locators for single-implant mandibular overdentures in edentate elderly individuals. Participants will be followed for three months with each attachment type; patient-based, clinical, and economic outcomes will be gathered. A sample of 26 participants is estimated to be required to detect clinically relevant differences in terms of the primary outcome (patient ratings of general satisfaction). Participants will choose which attachment they wish to keep, then be interviewed about their experiences and preferences with a single implant prosthesis and with the two attachments. Data from the quantitative and qualitative assessments will be integrated through a mixed-methods explanatory strategy. A last quantitative assessment will take place after 12 months with the preferred attachment; this latter assessment will enable measurement of the attachments' long-term wear and maintenance requirements. Our results will lead to evidence-based recommendations regarding these systems, guiding providers and patients when making decisions on which attachment systems and implant numbers will be most appropriate for individual cases. The recommendation of a specific attachment for elderly edentulous patients may combine positive outcomes from patient perspectives with low cost, good maintenance, and minimal invasiveness. ClinicalTrials.gov, NCT03126942 . Registered on 13 April 2017.

Acceptability and performance of the menstrual cup in South Africa: a randomized crossover trial comparing the menstrual cup to tampons or sanitary pads.

PubMed

Beksinska, Mags E; Smit, Jenni; Greener, Ross; Todd, Catherine S; Lee, Mei-ling Ting; Maphumulo, Virginia; Hoffmann, Vivian

2015-02-01

In low-income settings, many women and girls face activity restrictions during menses, owing to lack of affordable menstrual products. The menstrual cup (MC) is a nonabsorbent reusable cup that collects menstrual blood. We assessed the acceptability and performance of the MPower® MC compared to pads or tampons among women in a low-resource setting. We conducted a randomized two-period crossover trial at one site in Durban, South Africa, between January and November 2013. Participants aged 18-45 years with regular menstrual cycles were eligible for inclusion if they had no intention of becoming pregnant, were using an effective contraceptive method, had water from the municipal system as their primary water source, and had no sexually transmitted infections. We used a computer-generated randomization sequence to assign participants to one of two sequences of menstrual product use, with allocation concealed only from the study investigators. Participants used each method over three menstrual cycles (total 6 months) and were interviewed at baseline and monthly follow-up visits. The product acceptability outcome compared product satisfaction question scores using an ordinal logistic regression model with individual random effects. This study is registered on the South African Clinical Trials database: number DOH-27-01134273. Of 124 women assessed, 110 were eligible and randomly assigned to selected menstrual products. One hundred and five women completed all follow-up visits. By comparison to pads/tampons (usual product used), the MC was rated significantly better for comfort, quality, menstrual blood collection, appearance, and preference. Both of these comparative outcome measures, along with likelihood of continued use, recommending the product, and future purchase, increased for the MC over time. MC acceptance in a population of novice users, many with limited experience with tampons, indicates that there is a pool of potential users in low-resource settings.

Patient preferences and performance bias in a weight loss trial with a usual care arm☆☆☆

PubMed Central

McCambridge, Jim; Sorhaindo, Annik; Quirk, Alan; Nanchahal, Kiran

2014-01-01

Objectives This qualitative study examines performance bias, i.e. unintended differences between groups, in the context of a weight loss trial in which a novel patient counseling program was compared to usual care in general practice. Methods 14/381 consecutive interviewees (6 intervention group, 8 control group) within the CAMWEL (Camden Weight Loss) effectiveness trial process study were asked about their engagement with various features of the research study and a thematic content analysis undertaken. Results Decisions to participate were interwoven with decisions to change behavior, to the extent that for many participants the two were synonymous. The intervention group were satisfied with their allocation. The control group spoke of their disappointment at having been offered usual care when they had taken part in the trial to access new forms of help. Reactions to disappointment involved both movements toward and away from behavior change. Conclusion There is a prima facie case that reactions to disappointment may introduce bias, as they lead the randomized groups to differ in ways other than the intended experimental contrast. Practice implications In-depth qualitative studies nested within trials are needed to understand better the processes through which bias may be introduced. PMID:24492159

Overview of different available chemotherapy regimens combined with radiotherapy for the neoadjuvant and definitive treatment of esophageal cancer.

PubMed

Tomasello, Gianluca; Ghidini, Michele; Barni, Sandro; Passalacqua, Rodolfo; Petrelli, Fausto

2017-06-01

Neoadjuvant chemoradiotherapy (CTRT) is the current standard of care for treatment of locally advanced cancer of the esophagus or gastroesophageal junction. Many efforts have been made over the last years to identify the best chemotherapy and radiotherapy combination regimen, but specific randomized trials addressing this issue are still lacking. Areas covered: A systematic review of the literature was performed searching in PubMed all published studies of combinations CTRT regimens for operable or unresectable esophageal cancer to describe activity and toxicity. Studies considered were prospective series or clinical phase II-III trials including at least 40 patients and published in English language. Expert commentary: Long-term results of CROSS trial have established RT combined with carboplatin plus paclitaxel chemotherapy as the preferred neoadjuvant treatment option for both squamous and adenocarcinoma of the esophagus. More effective multimodal treatment strategies integrating novel biological agents including immunotherapy and based on an extensive molecular tumor characterization are eagerly awaited.

Ibuprofen versus acetaminophen with codeine for the relief of perineal pain after childbirth: a randomized controlled trial

PubMed Central

Peter, Elizabeth A.; Janssen, Patricia A.; Grange, Caroline S.; Douglas, M. Joanne

2001-01-01

Background Pain from episiotomy or tearing of perineal tissues during childbirth is often poorly treated and may be severe. This randomized double-blind controlled trial was performed to compare the effectiveness, side effects and cost of, and patient preference for, 2 analgesics for the management of postpartum perineal pain. Methods A total of 237 women who gave birth vaginally with episiotomy or a third- or fourth-degree tear between August 1995 and November 1996 at a tertiary-level teaching and referral centre for obstetric care in Vancouver were randomly assigned to receive either ibuprofen (400 mg) (n = 127) or acetaminophen (600 mg) with codeine (60 mg) and caffeine (15 mg) (Tylenol No. 3) (n = 110), both given orally every 4 hours as necessary. Pain ratings were recorded before the first dose and at 1, 2, 3, 4, 12 and 24 hours after the first dose on a 10-cm visual analogue scale. Side effects and overall opinion were assessed at 24 hours. Results Ibuprofen and acetaminophen with codeine had similar analgesic properties in the first 24 hours post partum (mean pain rating 3.4 and 3.3, mean number of doses in 24 hours 3.4 and 3.3, and proportion of treatment failures 13.8% [16/116] and 16.0% [16/100] respectively). Significantly fewer subjects in the ibuprofen group than in the acetaminophen with codeine group experienced side effects (52.4% v. 71.7%) (p = 0.006). There were no significant differences in overall patient satisfaction between the 2 groups. The major determinant of pain intensity was forceps-assisted delivery. Overall, 78% of the treatment failures were in women with forceps-assisted deliveries. Interpretation Since the 2 analgesics were rated similarly, ibuprofen may be the preferred choice because it is less expensive and requires less nursing time to dispense. Further studies need to address improved analgesia for women with forceps-assisted deliveries. PMID:11706909

Remote Collection of Patient-Reported Outcomes Following Outpatient Hand Surgery: A Randomized Trial of Telephone, Mail, and E-Mail.

PubMed

Schwartzenberger, Justin; Presson, Angela; Lyle, Adam; O'Farrell, Andrew; Tyser, Andrew R

2017-09-01

Obtaining remote patient-reported outcomes (PRO) is limited by low patient response rates and resource-intensive collection methods. We hypothesized that an e-mail-delivered Web-based data collection tool would outperform the traditional methods of telephone and standard mail for collecting long-term Boston Carpal Tunnel Questionnaire (BCTQ) scores at a minimum of 1 year following carpal tunnel release (CTR). We conducted a randomized trial of 969 patients who underwent CTR at a tertiary medical center within the past 5 years. Participants were randomized to the PRO collection methods of mail, telephone, and e-mail. The primary outcome was survey response rate at 1 year after surgery. Secondary analyses included data completeness and the effect of time from surgery, mode effects, and patient modality preference. At 1 year from surgery, the response rates were 64% for telephone and 42% for both mail and e-mail. Ninety-nine percent of telephone surveys were complete compared with 88% and 83% for mail and e-mail, respectively. There was no significant difference in the overall response rate at 1 or 5 years after surgery, nor in the BCTQ score between the modalities. A higher response rate and increased survey completeness was achieved by telephone contact methods compared with standard mailings or Web-based methods for PRO collection after CTR 1 to 5 years after surgery. A Web-based method demonstrated response rates equivalent to those of standard mail, was the most preferred modality, and offered logistical advantages such as automation and immediate integration with outcome databases. Obtaining PRO routinely after treatment may increase in importance. A Web-based interface may assist clinicians in decreasing the resource utilization typically associated with more traditional methods used to obtain outcome data. Copyright © 2017 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

What's in a title? An assessment of whether randomized controlled trial in a title means that it is one.

PubMed

Koletsi, Despina; Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2012-06-01

In this study, we aimed to investigate whether studies published in orthodontic journals and titled as randomized clinical trials are truly randomized clinical trials. A second objective was to explore the association of journal type and other publication characteristics on correct classification. American Journal of Orthodontics and Dentofacial Orthopedics, European Journal of Orthodontics, Angle Orthodontist, Journal of Orthodontics, Orthodontics and Craniofacial Research, World Journal of Orthodontics, Australian Orthodontic Journal, and Journal of Orofacial Orthopedics were hand searched for clinical trials labeled in the title as randomized from 1979 to July 2011. The data were analyzed by using descriptive statistics, and univariable and multivariable examinations of statistical associations via ordinal logistic regression modeling (proportional odds model). One hundred twelve trials were identified. Of the included trials, 33 (29.5%) were randomized clinical trials, 52 (46.4%) had an unclear status, and 27 (24.1%) were not randomized clinical trials. In the multivariable analysis among the included journal types, year of publication, number of authors, multicenter trial, and involvement of statistician were significant predictors of correctly classifying a study as a randomized clinical trial vs unclear and not a randomized clinical trial. From 112 clinical trials in the orthodontic literature labeled as randomized clinical trials, only 29.5% were identified as randomized clinical trials based on clear descriptions of appropriate random number generation and allocation concealment. The type of journal, involvement of a statistician, multicenter trials, greater numbers of authors, and publication year were associated with correct clinical trial classification. This study indicates the need of clear and accurate reporting of clinical trials and the need for educating investigators on randomized clinical trial methodology. Copyright © 2012 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

Effect of Oral Carbohydrate Intake on Labor Progress: Randomized Controlled Trial

PubMed Central

Rahmani, R; Khakbazan, Z; Yavari, P; Granmayeh, M; Yavari, L

2012-01-01

Background Lack of information regarding biochemical changes in women during labor and its outcomes on maternal and neonatal health still is an unanswered question. This study aims to explore the effectiveness of oral carbohydrate intake during labor on the duration of the active phase and other maternal and neonatal outcomes. Methods: A parallel prospective randomized controlled trial, conducted at the University Affiliated Teaching Hospital in Gonabad. Totally, 190 women were randomly assigned to an intervention (N=87) or control (N=90) group. Inclusion criteria were low-risk women with singleton cephalic presentation; and cervical dilatation 3–4 cm. Randomization was used by random number generator on every day. Odd numbers was used for intervention and even numbers for control group. Intervention was based on the preferences between: 3 medium dates plus 110 ml water; 3 dates plus 110 ml light tea without sugar; or 110 ml orange juice. The protocol is only run once but women ate and drank gradually before second stage of labor. Control group were fasted as routine practice. Neither participants nor care givers or staff could be blinded to group allocation. Differences between duration of the active phase of labor were assessed as primary outcome measure. Results: There was significant difference in the length of second stage of labor (P <.05). The effect size for this variable was 0.48. There were no significant differences in other maternal and neonatal outcomes. Conclusions: Oral intake of carbohydrate was an effective method for shortening the duration of second stage of labor in low-risk women. PMID:23304677

A randomized controlled study comparing internet-based cognitive behavioral therapy and counselling by standard care for fear of birth - A study protocol.

PubMed

Ternström, Elin; Hildingsson, Ingegerd; Haines, Helen; Karlström, Annika; Sundin, Örjan; Ekdahl, Johanna; Segeblad, Birgitta; Larsson, Birgitta; Rondung, Elisabet; Rubertsson, Christine

2017-10-01

Fear of birth is a concern that requires evidence based treatment. The aim of this study is to present the protocol of a randomized controlled multi-center trial to compare internet-based cognitive therapy with counseling as standard care for pregnant women reporting fear of birth. Participants will be recruited in mid-pregnancy. Women who score 60 or above on the Fear of Birth Scale will be offered to participate in this study. Data will be collected by questionnaires including validated instruments at baseline and follow-ups at gestational weeks 30 and 36, two months and one year after birth. The primary outcome will be level of fear of birth measured with the Fear of Birth Scale at 36 weeks of gestation. Secondary outcome measures are level of fear of birth at two months and one year after giving birth, preferences for mode of birth, requests for elective cesarean section, compliance and satisfaction with treatment and birth outcomes. A power calculation based on a 20% reduction of fear implies that approximately 200 will be included in the trial. The study outlined in this protocol will be the first randomized controlled trial comparing internet-based cognitive therapy with counseling for women reporting fear of birth. An effective treatment may result in better overall health for women with fear of birth and a reduction in cesarean sections for non-medical reasons. Evidence regarding treatment options of fear of birth will also provide a greater choice for women. Copyright © 2017 Elsevier B.V. All rights reserved.

A randomized controlled trial of Moderation-Oriented Cue Exposure.

PubMed

Heather, N; Brodie, J; Wale, S; Wilkinson, G; Luce, A; Webb, E; McCarthy, S

2000-07-01

A randomized controlled trial was conducted to examine the effectiveness of Moderation-Oriented Cue Exposure (MOCE) in comparison to Behavioral Self-Control Training (BSCT). The main hypothesis was that MOCE would be more effective than BSCT among a sample of problem drinkers aiming at moderate drinking. A subsidiary hypothesis was that MOCE would be relatively more effective than BSCT among problem drinkers with higher levels of alcohol dependence. Clients (N = 91; 75% men) were randomly allocated to either MOCE or BSCT. Treatment was delivered in weekly sessions by two trained therapists, in a nested design in which therapists switched to the alternative treatment modality approximately halfway through the trial. Follow-up was carried out 6 months following posttreatment assessment, with 85% successful contact. There was no evidence for the general superiority of MOCE over BSCT. The subsidiary hypothesis was not confirmed. A subsample of clients (n = 14) showing levels of dependence at baseline above the commonly accepted cut-point for a moderation goal (Severity of Alcohol Dependence Questionnaire [SADQ] > 29) showed outcomes at least as favorable as those below the cut-point. The validity of self-reports of alcohol consumption and problems was supported by significant relationships with liver function tests (gamma-glutamyl transferase and alanine transferase). These results provide no grounds for the replacement of BSCT by MOCE in routine, moderation-oriented treatment practice. Assuming they prefer it to abstinence and that it is not contra-indicated on other grounds, there seems no reason why clients showing a higher level of dependence (SADQ = 30-45) should not be offered a moderation goal.

Cost-minimization analysis in a blind randomized trial on small-incision versus laparoscopic cholecystectomy from a societal perspective: sick leave outweighs efforts in hospital savings

PubMed Central

Keus, Frederik; de Jonge, Trudy; Gooszen, Hein G; Buskens, Erik; van Laarhoven, Cornelis JHM

2009-01-01

Background After its introduction, laparoscopic cholecystectomy rapidly expanded around the world and was accepted the procedure of choice by consensus. However, analysis of evidence shows no difference regarding primary outcome measures between laparoscopic and small-incision cholecystectomy. In absence of clear clinical benefit it may be interesting to focus on the resource use associated with the available techniques, a secondary outcome measure. This study focuses on a difference in costs between laparoscopic and small-incision cholecystectomy from a societal perspective with emphasis on internal validity and generalisability Methods A blinded randomized single-centre trial was conducted in a general teaching hospital in The Netherlands. Patients with reasonable to good health diagnosed with symptomatic cholecystolithiasis scheduled for cholecystectomy were included. Patients were randomized between laparoscopic and small-incision cholecystectomy. Total costs were analyzed from a societal perspective. Results Operative costs were higher in the laparoscopic group using reusable laparoscopic instruments (difference 203 euro; 95% confidence interval 147 to 259 euro). There were no significant differences in the other direct cost categories (outpatient clinic and admittance related costs), indirect costs, and total costs. More than 60% of costs in employed patients were caused by sick leave. Conclusion Based on differences in costs, small-incision cholecystectomy seems to be the preferred operative technique over the laparoscopic technique both from a hospital and societal cost perspective. Sick leave associated with convalescence after cholecystectomy in employed patients results in considerable costs to society. Trial registration ISRCTN Register, number ISRCTN67485658. PMID:19732431

Single-visit or multiple-visit root canal treatment: systematic review, meta-analysis and trial sequential analysis

PubMed Central

Schwendicke, Falk; Göstemeyer, Gerd

2017-01-01

Objectives Single-visit root canal treatment has some advantages over conventional multivisit treatment, but might increase the risk of complications. We systematically evaluated the risk of complications after single-visit or multiple-visit root canal treatment using meta-analysis and trial-sequential analysis. Data Controlled trials comparing single-visit versus multiple-visit root canal treatment of permanent teeth were included. Trials needed to assess the risk of long-term complications (pain, infection, new/persisting/increasing periapical lesions ≥1 year after treatment), short-term pain or flare-up (acute exacerbation of initiation or continuation of root canal treatment). Sources Electronic databases (PubMed, EMBASE, Cochrane Central) were screened, random-effects meta-analyses performed and trial-sequential analysis used to control for risk of random errors. Evidence was graded according to GRADE. Study selection 29 trials (4341 patients) were included, all but 6 showing high risk of bias. Based on 10 trials (1257 teeth), risk of complications was not significantly different in single-visit versus multiple-visit treatment (risk ratio (RR) 1.00 (95% CI 0.75 to 1.35); weak evidence). Based on 20 studies (3008 teeth), risk of pain did not significantly differ between treatments (RR 0.99 (95% CI 0.76 to 1.30); moderate evidence). Risk of flare-up was recorded by 8 studies (1110 teeth) and was significantly higher after single-visit versus multiple-visit treatment (RR 2.13 (95% CI 1.16 to 3.89); very weak evidence). Trial-sequential analysis revealed that firm evidence for benefit, harm or futility was not reached for any of the outcomes. Conclusions There is insufficient evidence to rule out whether important differences between both strategies exist. Clinical significance Dentists can provide root canal treatment in 1 or multiple visits. Given the possibly increased risk of flare-ups, multiple-visit treatment might be preferred for certain teeth (eg, those with periapical lesions). PMID:28148534

Patient Perception of Physician Compassion After a More Optimistic vs a Less Optimistic Message: A Randomized Clinical Trial.

PubMed

Tanco, Kimberson; Rhondali, Wadih; Perez-Cruz, Pedro; Tanzi, Silvia; Chisholm, Gary B; Baile, Walter; Frisbee-Hume, Susan; Williams, Janet; Masino, Charles; Cantu, Hilda; Sisson, Amy; Arthur, Joseph; Bruera, Eduardo

2015-05-01

Information regarding treatment options and prognosis is essential for patient decision making. Patient perception of physicians as being less compassionate when they deliver bad news might be a contributor to physicians' reluctance in delivering these types of communication. To compare patients' perception of physician compassion after watching video vignettes of 2 physicians conveying a more optimistic vs a less optimistic message, determine patients' physician preference after watching both videos, and establish demographic and clinical predictors of compassion. Randomized clinical trial at an outpatient supportive care center in a cancer center in Houston, Texas, including English-speaking adult patients with advanced cancer who were able to understand the nature of the study and complete the consent process. Actors and patients were blinded to the purpose of the study. Investigators were blinded to the videos observed by the patient. One hundred patients were randomized to observe 2 standardized, roughly 4-minute videos depicting a physician discussing treatment information (more optimistic message vs less optimistic message) with a patient with advanced cancer. Both physicians made an identical number of empathetic statements (5) and displayed identical posture. After viewing each video, patients completed assessments including the Physician Compassion Questionnaire (0 = best, 50 = worst). Patients' perception of physician compassion after being exposed to a more optimistic vs an equally empathetic but less optimistic message. Patients reported significantly better compassion scores after watching the more optimistic video as compared with the less optimistic video (median [interquartile range], 15 [5-23] vs 23 [10-31]; P < .001). There was a sequence effect favoring the second video on both compassion scores (P < .001) and physician preference (P < .001). Higher perception of compassion was found to be associated with greater trust in the medical profession independent of message type: 63 patients observing the more optimistic message ranked the physician as trustworthy vs 39 after the less optimistic message (P = .03). Patients perceived a higher level of compassion and preferred physicians who provided a more optimistic message. More research is needed in structuring less optimistic message content to support health care professionals in delivering less optimistic news. clinicaltrials.gov Identifier: NCT02357108.

Pregnant Women's Views on the Feasibility and Acceptability of Web-Based Mental Health E-Screening Versus Paper-Based Screening: A Randomized Controlled Trial.

PubMed

Kingston, Dawn; Austin, Marie-Paule; Veldhuyzen van Zanten, Sander; Harvalik, Paula; Giallo, Rebecca; McDonald, Sarah D; MacQueen, Glenda; Vermeyden, Lydia; Lasiuk, Gerri; Sword, Wendy; Biringer, Anne

2017-04-07

Major international guidelines recommend mental health screening during the perinatal period. However, substantial barriers to screening have been reported by pregnant and postpartum women and perinatal care providers. E-screening offers benefits that may address implementation challenges. The primary objective of this randomized controlled trial was to evaluate the feasibility and acceptability of Web-based mental health e-screening compared with paper-based screening among pregnant women. A secondary objective was to identify factors associated with women's preferences for e-screening and disclosure of mental health concerns. Pregnant women recruited from community and hospital-based antenatal clinics and hospital-based prenatal classes were computer-randomized to a fully automated Web-based e-screening intervention group or a paper-based control group. Women were eligible if they spoke or read English, were willing to be randomized to e-screening, and were willing to participate in a follow-up diagnostic interview. The intervention group completed the Antenatal Psychosocial Health Assessment and the Edinburgh Postnatal Depression Scale on a tablet computer, while controls completed them on paper. All women completed self-report baseline questions and were telephoned 1 week after randomization by a blinded research assistant for a MINI International Neuropsychiatric Interview. Renker and Tonkin's tool of feasibility and acceptability of computerized screening was used to assess the feasibility and acceptability of e-screening compared with paper-based screening. Intention-to-treat analysis was used. To identify factors associated with preference for e-screening and disclosure, variables associated with each outcome at P<.20 were simultaneously entered into final multivariable models to estimate adjusted odds ratios (AORs) and 95% CIs. Of the 675 eligible women approached, 636 agreed to participate (participation rate 94.2%) and were randomized to the intervention (n=305) or control (n=331) groups. There were no significant baseline differences between groups. More women in the e-screening group strongly or somewhat agreed that they would like to use a tablet for answering questions on emotional health (57.9%, 175/302 vs 37.2%, 121/325) and would prefer using a tablet to paper (46.0%, 139/302 vs 29.2%, 95/325), compared with women in the paper-based screening group. There were no differences between groups in women's disclosure of emotional health concerns (94.1%, 284/302 vs 90.2%, 293/325). Women in the e-screening group consistently reported the features of e-screening more favorably than controls (more private or confidential, less impersonal, less time-consuming). In the multivariable models, being in the e-screening group was significantly associated with preferring e-screening (AOR 2.29, 95% CI 1.66-3.17), while no factors were significantly associated with disclosure. The findings suggest that mental health e-screening is feasible and acceptable to pregnant women. Clinicaltrials.gov NCT01899534; https://clinicaltrials.gov/ct2/show/NCT01899534 (Archived by WebCite at http://www.webcitation.org/6ntWg1yWb). ©Dawn Kingston, Marie-Paule Austin, Sander Veldhuyzen van Zanten, Paula Harvalik, Rebecca Giallo, Sarah D McDonald, Glenda MacQueen, Lydia Vermeyden, Gerri Lasiuk, Wendy Sword, Anne Biringer. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 07.04.2017.

Mate choice and genetic monogamy in a biparental, colonial fish.

PubMed

Schaedelin, Franziska C; van Dongen, Wouter F D; Wagner, Richard H

2015-01-01

In socially monogamous species, in which both sexes provide essential parental care, males as well as females are expected to be choosy. Whereas hundreds of studies have examined monogamy in biparental birds, only several such studies exist in fish. We examined mate choice in the biparental, colonial cichlid fish Neolamprologus caudopunctatus in Lake Tanganyika, Zambia. We genotyped more than 350 individuals at 11 microsatellite loci to investigate their mating system. We found no extrapair paternity, identifying this biparental fish as genetically monogamous. Breeders paired randomly according to their genetic similarity, suggesting a lack of selection against inbreeding avoidance. We further found that breeders paired assortatively by body size, a criterion of quality in fish, suggesting mutual mate choice. In a subsequent mate preference test in an aquarium setup, females showed a strong preference for male size by laying eggs near the larger of 2 males in 13 of 14 trials.

Mate choice and genetic monogamy in a biparental, colonial fish

PubMed Central

van Dongen, Wouter F.D.; Wagner, Richard H.

2015-01-01

In socially monogamous species, in which both sexes provide essential parental care, males as well as females are expected to be choosy. Whereas hundreds of studies have examined monogamy in biparental birds, only several such studies exist in fish. We examined mate choice in the biparental, colonial cichlid fish Neolamprologus caudopunctatus in Lake Tanganyika, Zambia. We genotyped more than 350 individuals at 11 microsatellite loci to investigate their mating system. We found no extrapair paternity, identifying this biparental fish as genetically monogamous. Breeders paired randomly according to their genetic similarity, suggesting a lack of selection against inbreeding avoidance. We further found that breeders paired assortatively by body size, a criterion of quality in fish, suggesting mutual mate choice. In a subsequent mate preference test in an aquarium setup, females showed a strong preference for male size by laying eggs near the larger of 2 males in 13 of 14 trials. PMID:26023276

Targeted versus tailored multimedia patient engagement to enhance depression recognition and treatment in primary care: randomized controlled trial protocol for the AMEP2 study

PubMed Central

2013-01-01

Background Depression in primary care is common, yet this costly and disabling condition remains underdiagnosed and undertreated. Persisting gaps in the primary care of depression are due in part to patients’ reluctance to bring depressive symptoms to the attention of their primary care clinician and, when depression is diagnosed, to accept initial treatment for the condition. Both targeted and tailored communication strategies offer promise for fomenting discussion and reducing barriers to appropriate initial treatment of depression. Methods/design The Activating Messages to Enhance Primary Care Practice (AMEP2) Study is a stratified randomized controlled trial comparing two computerized multimedia patient interventions --- one targeted (to patient gender and income level) and one tailored (to level of depressive symptoms, visit agenda, treatment preferences, depression causal attributions, communication self-efficacy and stigma)--- and an attention control. AMEP2 consists of two linked sub-studies, one focusing on patients with significant depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] scores ≥ 5), the other on patients with few or no depressive symptoms (PHQ-9 < 5). The first sub-study examined effectiveness of the interventions; key outcomes included delivery of components of initial depression care (antidepressant prescription or mental health referral). The second sub-study tracked potential hazards (clinical distraction and overtreatment). A telephone interview screening procedure assessed patients for eligibility and oversampled patients with significant depressive symptoms. Sampled, consenting patients used computers to answer survey questions, be randomized, and view assigned interventions just before scheduled primary care office visits. Patient surveys were also collected immediately post-visit and 12 weeks later. Physicians completed brief reporting forms after each patient’s index visit. Additional data were obtained from medical record abstraction and visit audio recordings. Of 6,191 patients assessed, 867 were randomized and included in analysis, with 559 in the first sub-study and 308 in the second. Discussion Based on formative research, we developed two novel multimedia programs for encouraging patients to discuss depressive symptoms with their primary care clinicians. Our computer-based enrollment and randomization procedures ensured that randomization was fully concealed and data missingness minimized. Analyses will focus on the interventions’ potential benefits among depressed persons, and the potential hazards among the non-depressed. Trial registration ClinicialTrials.gov Identifier: http://NCT01144104 PMID:23594572

Ethics in the Use of Extracorporeal Cardiopulmonary Resuscitation in Adults

PubMed Central

Riggs, Kevin R.; Becker, Lance B.; Sugarman, Jeremy

2015-01-01

Extracorporeal cardiopulmonary resuscitation (ECPR) promises to be an important advance in the treatment of cardiac arrest. However, ECPR involves ethical challenges that should be addressed as it diffuses into practice. Benefits and risks are uncertain, so the evidence base needs to be further developed, at least through outcomes registries and potentially with randomized trials. To inform decision making, patients’ preferences regarding ECPR should be obtained, both from the general population and from inpatients at risk for cardiac arrest. Fair and transparent appropriate use criteria should be developed and could be informed by economic analyses. PMID:25866287

The CHOLEGAS study: multicentric randomized, blinded, controlled trial of gastrectomy plus prophylactic cholecystectomy versus gastrectomy only, in adults submitted to gastric cancer surgery with curative intent.

PubMed

Farsi, Marco; Bernini, Marco; Bencini, Lapo; Miranda, Egidio; Manetti, Roberto; de Manzoni, Giovanni; Verlato, Giuseppe; Marrelli, Daniele; Pedrazzani, Corrado; Roviello, Francesco; Marchet, Alberto; Cristadoro, Luigi; Gerard, Leonardo; Moretti, Renato

2009-05-15

The incidence of gallstones and gallbladder sludge is known to be higher in patients after gastrectomy than in general population. This higher incidence is probably related to surgical dissection of the vagus nerve branches and the anatomical gastrointestinal reconstruction. Therefore, some surgeons perform routine concomitant cholecystectomy during standard surgery for gastric malignancies. However, not all the patients who are diagnosed to have cholelithiasis after gastric cancer surgery will develop symptoms or require additional surgical treatments and a standard laparoscopic cholecystectomy is feasible even in those patients who underwent previous gastric surgery. At the present, no randomized study has been published and the decision of gallbladder management is left to each surgeon preference. The study is a randomized controlled investigation. The study will be performed in the General and Oncologic Surgery, Department of Oncology-Azienda Ospedaliero-Universitaria Careggi-Florence-Italy, a large teaching institution, with the participation of all surgeons who accept to be involved in, together with other Italian Surgical Centers, on behalf of the GIRCG (Italian Research Group for Gastric Cancer).The patients will be randomized into two groups: in the first group the patient will be submitted to prophylactic cholecystectomy during standard surgery for curable gastric cancer (subtotal or total gastrectomy), while in the second group he/she will be submitted to standard gastric surgery only. ClinicalTrials.gov ID. NCT00757640.

Postremission treatment of elderly patients with acute myeloid leukemia in first complete remission after intensive induction chemotherapy: results of the multicenter randomized Acute Leukemia French Association (ALFA) 9803 trial.

PubMed

Gardin, Claude; Turlure, Pascal; Fagot, Thierry; Thomas, Xavier; Terre, Christine; Contentin, Nathalie; Raffoux, Emmanuel; de Botton, Stephane; Pautas, Cecile; Reman, Oumedaly; Bourhis, Jean-Henri; Fenaux, Pierre; Castaigne, Sylvie; Michallet, Mauricette; Preudhomme, Claude; de Revel, Thierry; Bordessoule, Dominique; Dombret, Herve

2007-06-15

In elderly patients with acute myeloid leukemia (AML) treated intensively, no best postremission strategy has emerged yet. This clinical trial enrolled 416 patients with AML aged 65 years or older who were considered eligible for standard intensive chemotherapy, with a first randomization comparing idarubicin with daunorubicin for all treatment sequences. After induction, an ambulatory postremission strategy based on 6 consolidation cycles administered monthly in outpatients was randomly compared with an intensive strategy with a single intensive consolidation course similar to induction. Complete remission (CR) rate was 57% with 10% induction deaths, and estimated overall survival was 27% at 2 years and 12% at 4 years, without notable differences between anthracycline arms. Among the 236 patients who reached CR, 164 (69%) were randomized for the postremission comparison. In these patients, the multivariate odds ratio in favor of the ambulatory arm was 1.51 for disease-free survival (P.05) and 1.59 for overall survival from CR (P.04). Despite repeated courses of chemotherapy associated with a longer time under treatment, the ambulatory arm was associated with significantly shorter rehospitalization duration and lower red blood cell unit and platelet transfusion requirements than observed in the intensive arm. In conclusion, more prolonged ambulatory treatment should be preferred to intensive chemotherapy as postremission therapy in elderly patients with AML reaching CR after standard intensive remission induction.

An exploratory trial exploring the use of a multiple intelligences teaching approach (MITA) for teaching clinical skills to first year undergraduate nursing students.

PubMed

Sheahan, Linda; While, Alison; Bloomfield, Jacqueline

2015-12-01

The teaching and learning of clinical skills is a key component of nurse education programmes. The clinical competency of pre-registration nursing students has raised questions about the proficiency of teaching strategies for clinical skill acquisition within pre-registration education. This study aimed to test the effectiveness of teaching clinical skills using a multiple intelligences teaching approach (MITA) compared with the conventional teaching approach. A randomised controlled trial was conducted. Participants were randomly allocated to an experimental group (MITA intervention) (n=46) and a control group (conventional teaching) (n=44) to learn clinical skills. Setting was in one Irish third-level educational institution. Participants were all first year nursing students (n=90) in one institution. The experimental group was taught using MITA delivered by the researcher while the control group was taught by a team of six experienced lecturers. Participant preference for learning was measured by the Index of Learning Styles (ILS). Participants' multiple intelligence (MI) preferences were measured with a multiple intelligences development assessment scale (MIDAS). All participants were assessed using the same objective structured clinical examination (OSCE) at the end of semester one and semester two. MI assessment preferences were measured by a multiple intelligences assessment preferences questionnaire. The MITA intervention was evaluated using a questionnaire. The strongest preference on ILS for both groups was the sensing style. The highest MI was interpersonal intelligence. Participants in the experimental group had higher scores in all three OSCEs (p<0.05) at Time 1, suggesting that MITA had a positive effect on clinical skill acquisition. Most participants favoured practical examinations, followed by multiple choice questions as methods of assessment. MITA was evaluated positively. The study findings support the use of MITA for clinical skills teaching and advance the understanding of how MI teaching approaches may be used in nursing education. Copyright © 2015 Elsevier Ltd. All rights reserved.

Equivalence of nasal and oronasal masks during initial CPAP titration for obstructive sleep apnea syndrome.

PubMed

Teo, Ming; Amis, Terence; Lee, Sharon; Falland, Karina; Lambert, Stephen; Wheatley, John

2011-07-01

Continuous positive airway pressure (CPAP) titration studies are commonly performed using a nasal mask but some patients may prefer a full-face or oronasal mask. There is little evidence regarding the equivalence of different mask interfaces used to initiate treatment. We hypothesized that oronasal breathing when using an oronasal mask increases upper airway collapsibility and that a higher pressure may be required to maintain airway patency. We also assessed patient preferences for the 2 mask interfaces. Prospective, randomized, cross-over design with 2 consecutive CPAP titration nights. Accredited laboratory in a university hospital. Twenty-four treatment-naive subjects with obstructive sleep apnea syndrome and respiratory disturbance index of greater than 15 events per hour. CPAP titration was performed using an auto-titrating machine with randomization to a nasal or oronasal mask, followed by a second titration night using the alternate mask style. There was no significant difference in the mean pressures determined between nasal and oronasal masks, although 43% of subjects had nasal-to-oronasal mask-pressure differences of 2 cm H(2)O or more. Residual respiratory events, arousals, and measured leak were all greater with the oronasal mask. Seventy-nine percent of subjects preferred the nasal mask. Patients with obstructive sleep apnea syndrome can generally switch between nasal and oronasal masks without changing machine pressure, although there are individual differences that may be clinically significant. Measured leak is greater with the oronasal mask. Most patients with obstructive sleep apnea syndrome prefer a nasal mask as the interface for initiation of CPAP. Australian New Zealand Clinical Trials Registry (ANZCTR). ACTRN: ACTRN12611000243910. URL: http://www.ANZCTR.org.au/ACTRN12611000243910.aspx

Serial personal digital assistant data capture of health-related quality of life: A randomized controlled trial in a prostate cancer clinic

PubMed Central

Matthew, Andrew G; Currie, Kristen L; Irvine, Jane; Ritvo, Paul; Santa Mina, Daniel; Jamnicky, Leah; Nam, Robert; Trachtenberg, John

2007-01-01

Background In clinical and research practice linked to prostate cancer treatment, frequent monitoring of patient health-related quality of life (HRQOL) is essential. Practical and analytic limitations of paper questionnaire data capture may be overcome with the use of self-administered personal digital assistant (PDA) data collection. The objective of this study was to assess the reliability, validity, and feasibility of using PDA in place of paper versions of the International Prostate Symptom Score (IPSS), the Patient Oriented Prostate Cancer Utility Survey (PORPUS), and the International Index of Erectile Function-5 (IIEF-5) in a prostate cancer clinic setting. Methods 152 participants were randomly assigned to one of three conditions: 1) paper followed by PDA survey; 2) PDA followed by paper survey; or 3) PDA followed by PDA survey. Evaluation included an assessment of data quality (internal consistency, test-retest reliability, response correlation, completeness of data), and feasibility (participation rates, time to completion, preference and difficultly/ease of using PDA). Results Internal consistency was similar for both PDA and paper applications. Test-retest reliability was confirmed for PDA repeated administration. Data from paper and PDA questionnaires were strongly correlated. Lower missed item rates were found in PDA administration. 82.8% of participants preferred using the PDA or had no preference. Mean difficulty/ease ratings indicated that participants found the PDA easy to use. Age did not significantly correlate with preference or difficulty. Conclusion The results confirm the adaptability of the IPSS, IIEF-5, and the PORPUS to PDA administration. Similarly, the findings of this study support the feasibility of using PDA technology for HRQOL serial data capture in the prostate cancer patient population. PMID:17617906

Mobile Versus Fixed Facility: Latinas' Attitudes and Preferences for Obtaining a Mammogram.

PubMed

Scheel, John R; Tillack, Allison A; Mercer, Lauren; Coronado, Gloria D; Beresford, Shirley A A; Molina, Yamile; Thompson, Beti

2018-01-01

Mobile mammographic services have been proposed as a way to reduce Latinas' disproportionate late-stage presentation compared with white women by increasing their access to mammography. The aims of this study were to assess why Latinas may not use mobile mammographic services and to explore their preferences after using these services. Using a mixed-methods approach, a secondary analysis was conducted of baseline survey data (n = 538) from a randomized controlled trial to improve screening mammography rates among Latinas in Washington. Descriptive statistics and bivariate regression were used to characterize mammography location preferences and to test for associations with sociodemographic indices, health care access, and perceived breast cancer risk and beliefs. On the basis of these findings, a qualitative study (n = 18) was used to explore changes in perceptions after using mobile mammographic services. More Latinas preferred obtaining a mammogram at a fixed facility (52.3% [n = 276]) compared with having no preference (46.3% [n = 249]) and preferring mobile mammographic services (1.7% [n = 9]). Concerns about privacy and comfort (15.6% [n = 84]) and about general quality (10.6% [n = 57]) were common reasons for preferring a fixed facility. Those with no history of mammography preferred a fixed facility (P < .05). In the qualitative study, Latinas expressed similar initial concerns but became positive toward the mobile mammographic services after obtaining a mammogram. Although most Latinas preferred obtaining a mammogram at a fixed facility, positive experiences with mobile mammography services changed their attitudes toward them. These findings highlight the need to include community education when using mobile mammographic service to increase screening mammography rates in underserved communities. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Feasibility study of the effects of art as a creative engagement intervention during stroke rehabilitation on improvement of psychosocial outcomes: study protocol for a single blind randomized controlled trial: the ACES study.

PubMed

Morris, Jacqui H; Kelly, Chris; Toma, Madalina; Kroll, Thilo; Joice, Sara; Mead, Gillian; Donnan, Peter; Williams, Brian

2014-09-28

Benefits of art participation after stroke are becoming increasingly recognized. Qualitative studies suggest that participation in visual arts creative engagement interventions (CEIs) during rehabilitation after stroke may improve mood, self-esteem, hope and some aspects of physical recovery. This study examines the feasibility of undertaking a randomized controlled trial of a CEI delivered by artists within in-patient stroke rehabilitation to test effectiveness. This trial is a two arm, single-blind, randomized controlled feasibility trial within in-patient stroke rehabilitation. We will recruit 80 patients receiving stroke rehabilitation in two stroke units in a health board area of Scotland (40 patients in each arm). Intervention arm participants will receive a visual-arts based CEI facilitated by experienced artists. Artists will follow an intervention protocol with specific components that enable participants to set, achieve and review artistic goals. Participants will receive up to eight intervention sessions, four within a group and four one-to-one with the artist. Control group participants will receive usual care only.Data collection will occur at baseline, post-intervention and three-month follow-up. Stroke-related health status is the primary outcome; mood, self-esteem, self-efficacy, perceived recovery control and hope are secondary outcomes. Semi-structured interviews will be conducted with purposively selected patients, artists and healthcare staff to elicit views and experiences of the intervention and feasibility and acceptability of trial processes. Recruitment rates, retention rates and patient preference for art participation will also be collected. Data will indicate, with confidence intervals, the proportion of patients choosing or refusing participation in the CEI and will allow calculation of recruitment rates for a future definitive trial. Summary data will indicate potential variability, magnitude and direction of difference between groups. Findings will inform sample size calculations for a definitive trial. Thematic analysis of qualitative data will be managed using the Framework Approach. Framework is an analytical approach for qualitative data, commonly used in policy and medical research. If shown to demonstrate effects, this intervention has the potential to address aspects of stroke recovery previously. Not routinely addressed in rehabilitation. Registered with Clinical Trials.Gov: NCT02085226 on 6th March 2014.

Fatty fish intake and attention performance in 14-15 year old adolescents: FINS-TEENS - a randomized controlled trial.

PubMed

Handeland, Katina; Øyen, Jannike; Skotheim, Siv; Graff, Ingvild E; Baste, Valborg; Kjellevold, Marian; Frøyland, Livar; Lie, Øyvind; Dahl, Lisbeth; Stormark, Kjell M

2017-10-02

Fatty fish is the dominant dietary source of n-3 LCPUFAs but it also contains other micronutrients considered important for brain development and function. To our knowledge, the effect of fatty fish intake on cognitive function in adolescents has not been investigated in randomized controlled trials (RCTs) previously. The aim of the present trial was to investigate whether consumption of fatty fish meals three times per week for 12 weeks could alter attention performance in adolescents compared to similar meals with meat or n-3 LCPUFA supplements. In the Fish Intervention Studies-TEENS (FINS-TEENS), adolescents from eight secondary schools (n = 426; age: 14-15y) were individually randomized. Attention performance was assessed with the d2 test of attention. Differences between groups from pre to post intervention were assessed with linear mixed effect models and general estimates equation. The fish group was set as reference. Dietary compliance was recorded for each meal throughout the trial and controlled for in the adjusted analyses. The improvement in processing speed was significantly lower in the meat (-11.8; 95% CI: -23.3, -0.4) and supplement (-13.4; 95% CI: -24.9, -1.8) group compared to the fish group (reference). The supplement group also showed inferior improvement in total performance (-10.4; 95% CI: -20.0, -0.7) compared to the fish group (reference). The results were slightly affected when controlling for dietary compliance. Omission errors decreased in the meat group compared to the fish group (Incidence rate ratio = 0.85; 95% CI: 0.74, 0.98), but the difference disappeared when controlling for dietary compliance. We observed a small beneficial effect of fatty fish, compared to meat meals and supplements on processing speed. However, these results are difficult to interpret due to low dietary compliance. This study shows that different taste preferences among participants is challenging in intervention trials with food. A prospective cohort design may be a better alternative when studying diet in the future. ClinicalTrials.gov registration number: NCT02350322 .

Randomized trials published in some Chinese journals: how many are randomized?

PubMed

Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David

2009-07-02

The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9-7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18-2.13, and relative risk 14.42, 95% confidence interval 9.40-22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83-14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0-81.0). Most reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing to a lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed.

Randomized trials published in some Chinese journals: how many are randomized?

PubMed Central

Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David

2009-01-01

Background The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. Methods The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. Results From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9–7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18–2.13, and relative risk 14.42, 95% confidence interval 9.40–22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83–14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0–81.0). Conclusion Most reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing toa lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed. PMID:19573242

Mobile access to virtual randomization for investigator-initiated trials.

PubMed

Deserno, Thomas M; Keszei, András P

2017-08-01

Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand. Methods The core of the system architecture is an electronic data capture system or a clinical trial management system, which is extended by an R interface connecting the R server using the Java R Interface. Mobile devices communicate via the representational state transfer web services. Furthermore, a simple web-based setup allows configuring the appropriate statistics by non-statisticians. Our comprehensive R script supports simple randomization, restricted randomization using a random allocation rule, block randomization, and stratified randomization for un-blinded, single-blinded, and double-blinded trials. For each trial, the electronic data capture system or the clinical trial management system stores the randomization parameters and the subject assignments. Results Apps are provided for iOS and Android and subjects are randomized using smartphones. After logging onto the system, the user selects the trial and the subject, and the allocation number and treatment arm are displayed instantaneously and stored in the core system. So far, 156 subjects have been allocated from mobile devices serving five investigator-initiated trials. Conclusion Transforming pre-printed allocation lists into virtual ones ensures the correct conduct of trials and guarantees a strictly sequential processing in all trial sites. Covering 88% of all randomization models that are used in recent trials, virtual randomization becomes available for investigator-initiated trials and potentially for large multi-center trials.

Lack of effect of exercise time of day on acute energy intake in healthy men.

PubMed

O'Donoghue K, J M; Fournier, Paul A; Guelfi, Kym J

2010-08-01

Although the manipulation of exercise and dietary intake to achieve successful weight loss has been extensively studied, it is unclear how the time of day that exercise is performed may affect subsequent energy intake. The purpose of the current study was to investigate the effect of an acute bout of exercise performed in the morning compared with an equivalent bout of exercise performed in the afternoon on short-term energy intake. Nine healthy male participants completed 3 trials: morning exercise (AM), afternoon exercise (PM), or control (no exercise; CON) in a randomized counterbalanced design. Exercise consisted of 45 min of treadmill running at 75% VO(2peak). Energy intake was assessed over a 26-hr period with the participants eating ad libitum from a standard assortment of food items of known quantity and composition. There was no significant difference in overall energy intake (M ± SD; CON 23,505 ± 6,938 kJ, AM 24,957 ± 5,607 kJ, PM 24,560 ± 5,988 kJ; p = .590) or macronutrient preferences during the 26-hr period examined between trials. Likewise, no differences in energy intake or macronutrient preferences were observed at any of the specific individual meal periods examined (i.e., breakfast, lunch, dinner) between trials. These results suggest that the time of day that exercise is performed does not significantly affect short-term energy intake in healthy men.

Women's Experiences with and Preference for Induction of Labor with Oral Misoprostol or Foley Catheter at Term.

PubMed

Ten Eikelder, Mieke L G; van de Meent, Marieke M; Mast, Kelly; Rengerink, Katrien Oude; Jozwiak, Marta; de Graaf, Irene M; Scholtenhuis, Marloes A G Holswilder-Olde; Roumen, Frans J M E; Porath, Martina M; van Loon, Aren J; van den Akker, Eline S; Rijnders, Robbert J P; Feitsma, A Hanneke; Adriaanse, Albert H; Muller, Moira A; de Leeuw, Jan W; Visser, Harry; Woiski, Mallory D; Weerd, Sabina Rombout-de; van Unnik, Gijs A; Pernet, Paula J M; Versendaal, Hans; Mol, Ben W; Bloemenkamp, Kitty W M

2017-01-01

Objective  We assessed experience and preferences among term women undergoing induction of labor with oral misoprostol or Foley catheter. Study Design  In 18 of the 29 participating hospitals in the PROBAAT-II trial, women were asked to complete a questionnaire within 24 hours after delivery. We adapted a validated questionnaire about expectancy and experience of labor and asked women whether they would prefer the same method again in a future pregnancy. Results  The questionnaire was completed by 502 (72%) of 695 eligible women; 273 (54%) had been randomly allocated to oral misoprostol and 229 (46%) to Foley catheter. Experience of the duration of labor, pain during labor, general satisfaction with labor, and feelings of control and fear related to their expectation were comparable between both the groups. In the oral misoprostol group, 6% of the women would prefer the other method if induction is necessary in future pregnancy, versus 12% in the Foley catheter group (risk ratio: 0.70; 95% confidence interval: 0.55-0.90; p =  0.02). Conclusion  Women's experiences of labor after induction with oral misoprostol or Foley catheter are comparable. However, women in the Foley catheter group prefer more often to choose a different method for future inductions. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Not all numbers are equal: preferences and biases among children and adults when generating random sequences.

PubMed

Towse, John N; Loetscher, Tobias; Brugger, Peter

2014-01-01

We investigate the number preferences of children and adults when generating random digit sequences. Previous research has shown convincingly that adults prefer smaller numbers when randomly choosing between responses 1-6. We analyze randomization choices made by both children and adults, considering a range of experimental studies and task configurations. Children - most of whom are between 8 and 11~years - show a preference for relatively large numbers when choosing numbers 1-10. Adults show a preference for small numbers with the same response set. We report a modest association between children's age and numerical bias. However, children also exhibit a small number bias with a smaller response set available, and they show a preference specifically for the numbers 1-3 across many datasets. We argue that number space demonstrates both continuities (numbers 1-3 have a distinct status) and change (a developmentally emerging bias toward the left side of representational space or lower numbers).

Pharmacologic conversion of atrial fibrillation: a systematic review of available evidence.

PubMed

Slavik, R S; Tisdale, J E; Borzak, S

2001-01-01

This report reviews the efficacy of currently available antiarrhythmic agents for conversion of atrial fibrilation (AF) to normal sinus rhythm (NSR). A systematic search of literature in the English language was done on computerized databases, such as MEDLINE, EMBASE, and Current Contents, in reference lists, by manual searching, and in contact with expert informants. Published studies involving humans that described the use of antiarrhythmic therapy for conversion of AF to NSR were considered and only studies that examined the use of agents currently available in the United States were included. Studies exclusively describing antiarrhythmic therapy for conversion of postsurgical AF were excluded. The methodology and results of each trial were assessed and attempts were made to acquire additional information from investigators when needed. Assessment of methodological quality was incorporated into a levels-of-evidence scheme. Eighty-eight trials were included, of which 34 (39%) included a placebo group (level I data). We found in recent-onset AF of less than 7 days, intravenous (i.v.) procainamide, high-dose i.v. or high-dose combination i.v. and oral amiodarone, oral quinidine, oral flecainide, oral propafenone, and high-dose oral amiodarone are more effective than placebo for converting AF to NSR. In recent-onset AF of less than 90 days, i.v. ibutilide is more effective than placebo and i.v. procainamide. In chronic AF, oral dofetilide converts AF to NSR within 72 hours, and oral propafenone and amiodarone are effective after 30 days of therapy. We conclude than for conversion of recent-onset AF of less than 7 days, procainamide may be considered a preferred i.v. agent and propafenone a preferred oral agent. For conversion of recent-onset AF of longer duration (less than 90 days), i.v. ibutilide may be considered a preferred agent. For patients with chronic AF and left ventricular dysfunction, direct current cardioversion is the preferred conversion method. Larger, well-designed randomized controlled trials with clinically important endpoints in specific populations of AF patients are needed. Copyright 2001 by W.B. Saunders Company

The impact of high- and low-preference stimuli on vocational and academic performances of youths with severe disabilities.

PubMed

Graff, Richard B; Gibson, Lenwood; Galiatsatos, G Tracey

2006-01-01

Pictorial and tangible paired-stimulus preference assessments were compared with 4 adolescents with developmental disabilities. In the tangible assessment, two stimuli were placed in front of the participant on each trial; in the pictorial assessment, two line drawings were placed in front of the participant on each trial. Approach responses were recorded for each assessment. The assessments generated similar preference hierarchies for all participants. Reinforcer assessments confirmed that response rates were higher when access to high-preference items was available than when low-preference items were available. Implications for assessing preferences and selecting items to be used in training programs are discussed.

Development of questionnaires to measure patient preferences for intranasal corticosteroids in patients with allergic rhinitis.

PubMed

Meltzer, Eli O; Hadley, James; Blaiss, Michael; Benninger, Michael; Kimel, Miriam; Kleinman, Leah; Dupclay, Leon; Garcia, Jorge; Leahy, Michael; Georges, George

2005-02-01

To develop a questionnaire to evaluate preferences for attributes of intranasal corticosteroids (INSs) in clinical trials with allergic rhinitis (AR) patients. Established questionnaire development practices were used, including performance of a literature review and use of patient and physician focus groups, cognitive debriefing interviews, and pilot testing before validation. Findings from patient and physician focus groups suggest that sensory attributes are relevant to AR patients when choosing INSs. Physician focus groups identified the need for 2 distinct preference instruments, a clinical trial patient preference questionnaire (CTPPQ) and a clinical practice preference questionnaire (CPPPQ). A pilot study suggests that the CTPPQ is capable of discriminating between 2 INSs in the clinical trial setting. Initial findings suggest that items in the CTPPQ and CPPPQ are easy to understand and relevant to patients. Further validation studies with larger sample sizes are needed to assess the psychometric properties of both questionnaires. B-20.

The preference to receive chemotherapy and cancer-related outcomes in older adults with breast cancer CALGB 49907 (Alliance).

PubMed

Gajra, Ajeet; McCall, Linda; Muss, Hyman B; Cohen, Harvey J; Jatoi, Aminah; Ballman, Karla V; Partridge, Ann H; Sutton, Linda; Parker, Barbara A; Magrinat, Gustav; Klepin, Heidi D; Lafky, Jacqueline M; Hurria, Arti

2018-05-01

Chemotherapy preference refers to a patient's interest in receiving chemotherapy. This study examined whether chemotherapy preference was associated with toxicity, efficacy, quality of life (QoL), and functional outcomes during and after completion of adjuvant chemotherapy in older women with breast cancer. This study is a secondary analysis of CALGB 49907, a randomized trial that compared standard adjuvant chemotherapy versus capecitabine in patients age 65 years or older with breast cancer. A subset of 145 patients completed a questionnaire to describe chemotherapy preference pre-treatment. The association of this pre-treatment preference with the patient's perception of self-health, predicted and actual QoL, patient- and professional-reported toxicity, mental health, self-rated function, and survival was studied during and after treatment. The median age of patients was 71 years and 47% had a high preference for chemotherapy. On baseline demographics, the low preference group had a higher proportion of white patients (95% vs. 78%, p = 0.004). Before treatment, low chemotherapy preference was associated with greater nausea/vomiting (p = 0.008). Mid-treatment, low preference was associated with lower QoL, worse social, emotional and physical function (all p ≤ 0.02) and worse nausea/vomiting, cancer symptoms and financial worries (all p < 0.05). The association noted mid-treatment, resolved after treatment completion except with financial worries which persisted at 24 months. Low preference was associated with higher rates of grade 3-5 adverse events (53% vs. 34%, p = 0.02) but was not associated with survival. Low chemotherapy preference prior to treatment initiation was associated with lower QoL, worse physical symptoms and self-rated function and more adverse events mid-treatment. There is no association of chemotherapy preference with survival. Copyright © 2018 Elsevier Ltd. All rights reserved.

Recent advances in the treatment of air leaks.

PubMed

Cerfolio, Robert James

2005-07-01

Alveolar-pleural fistulas (air leaks) are an extremely common clinical problem and remain the most common complication after elective pulmonary resection and video-assisted procedures. The decision making process used to manage air leaks and chest tubes that control them has been, until very recently, based on opinions and training preferences as opposed to facts derived from randomized clinical trials. Recently, several prospective randomized trials have studied air leaks. An objective, reproducible classification system has also been designed and clinically validated to help study air leaks. This system and these studies have shown that water seal is superior to wall suction to help stop most leaks. Even in patients with a pneumothorax and an air leak, water seal is safe and best; however, if a patient has a large leak (greater than an expiratory 3 on the classification system) or experiences subcutaneous emphysema or an expanding pneumothorax that causes hypoxia, then some suction (-10 cm of water) should be applied to the chest tubes. Air leaks were a poorly understood yet extremely common clinical problem that had never been scientifically studied. Over the past 5 years, prospective randomized studies have shown that water seal is the best setting for chest tubes and that a pneumothorax is not a contraindication to leaving tubes on seal. Further studies are needed to investigate the ideal management of alveolar-pleural fistulas (air leaks) in different clinical scenarios besides those that occur postoperatively.

To share or not to share: a randomized trial of consent for data sharing in genome research.

PubMed

McGuire, Amy L; Oliver, Jill M; Slashinski, Melody J; Graves, Jennifer L; Wang, Tao; Kelly, P Adam; Fisher, William; Lau, Ching C; Goss, John; Okcu, Mehmet; Treadwell-Deering, Diane; Goldman, Alica M; Noebels, Jeffrey L; Hilsenbeck, Susan G

2011-11-01

Despite growing concerns toward maintaining participants' privacy, individual investigators collecting tissue and other biological specimens for genomic analysis are encouraged to obtain informed consent for broad data sharing. Our purpose was to assess the effect on research enrollment and data sharing decisions of three different consent types (traditional, binary, or tiered) with varying levels of control and choices regarding data sharing. A single-blinded, randomized controlled trial was conducted with 323 eligible adult participants being recruited into one of six genome studies at Baylor College of Medicine in Houston, Texas, between January 2008 and August 2009. Participants were randomly assigned to one of three experimental consent documents (traditional, n = 110; binary, n = 103; and tiered, n = 110). Debriefing in follow-up visits provided participants a detailed review of all consent types and the chance to change data sharing choices or decline genome study participation. Before debriefing, 83.9% of participants chose public data release. After debriefing, 53.1% chose public data release, 33.1% chose restricted (controlled access database) release, and 13.7% opted out of data sharing. Only one participant declined genome study participation due to data sharing concerns. Our findings indicate that most participants are willing to publicly release their genomic data; however, a significant portion prefers restricted release. These results suggest discordance between existing data sharing policies and participants' judgments and desires.

Primary care guidelines on consultation practices: the effectiveness of computerized versus paper-based versions. A cluster randomized controlled trial among newly qualified primary care physicians.

PubMed

Jousimaa, Jukkapekka; Mäkelä, Marjukka; Kunnamo, Ilkka; MacLennan, Graeme; Grimshaw, Jeremy M

2002-01-01

To compare the effects of computerized and paper-based versions of guidelines on recently qualified physicians' consultation practices. Two arm cluster randomized controlled trial. Physicians were randomized to receive computerized or textbook-based versions of the same guidelines for a 4-week study period. Physicians' compliance with guideline recommendations about laboratory, radiological, physical and other examinations, procedures, nonpharmacologic and pharmacologic treatments, physiotherapy, and referrals were measured by case note review. There were 139 recently qualified physicians working in 96 primary healthcare centers in Finland who participated in the study. Data on 4,633 patient encounters were abstracted, of which 3,484 were suitable for further analysis. Physicians' compliance with guidelines was high (over 80% for use of laboratory, radiology, physical examinations, and referrals). There were no significant differences in physicians' consultation practices in any of the measured outcomes between the computerized and textbook group. Guidelines are a useful source of information for recently qualified physicians working in primary care. However, the method of presentation of the guidelines (electronic or paper) does not have an effect on guideline use or their impact on decisions. Other factors should be considered when choosing the method of presentation of guidelines, such as information-seeking time, ease of use during the consultation, ability to update, production costs, and the physician's own preferences.

Laparoscopic Gastric Bypass for Morbid Obesity–a Randomized Controlled Trial Comparing Two Gastrojejunal Anastomosis Techniques

PubMed Central

Llopis, Salvador Navarrete; Isaac, Jose; Aulestia, Salvador Navarrete; Bravo, Carlos; Obregon, Francisco

2008-01-01

Objectives: We present a randomized controlled trial of laparoscopic gastric bypass comparing 2 techniques of gastrojejunostomy in patients with morbid obesity. Methods: Eighty consecutive patients underwent laparoscopic Roux-en-Y gastric bypass between September 2005 and August 2006. Patients were randomly assigned to 2 groups by the use of sealed envelopes. In group A, the gastrojejunal anastomosis was performed with a 21-mm circular-stapler, and in group B, this anastomosis was performed with a 45-mm linear-stapler. The rest of the procedure was identical in both groups. Variables evaluated were complications involving the gastrojejunostomy, operative time, length of stay, and percentage of excess weight loss. Results: Both groups were similar in age and body mass index. No patients experienced leakage or gastrojejunal anastomosis fistula, but group A patients had a more frequent stricture rate (P<0.05). Operative time and hospital stay were comparable in both groups (P>0.05). Percentage excess weight loss at one year following surgery was satisfactory in both groups, without a statistically significant difference (P>0.05). Conclusion: Gastrojejunal anastomosis does not seem to be a critical factor in excess weight loss for morbidly obese patients who underwent laparoscopic gastric bypass. The 2 techniques used in this experience are safe and effective; however, the 45-mm liner-stapler is preferable because it has a lower stricture rate. PMID:19275854

Why does primary angioplasty not work in registries? Quantifying the susceptibility of real-world comparative effectiveness data to allocation bias.

PubMed

Sen, Sayan; Davies, Justin E; Malik, Iqbal S; Foale, Rodney A; Mikhail, Ghada W; Hadjiloizou, Nearchos; Hughes, Alun; Mayet, Jamil; Francis, Darrel P

2012-11-01

Meta-analysis of registries (comparative effectiveness research) shows that primary angioplasty and fibrinolysis have equivalent real-world survival. Yet, randomized, controlled trials consistently find primary angioplasty superior. Can unequal allocation of higher-risk patients in registries have masked primary angioplasty benefit? First, we constructed a model to demonstrate the potential effect of allocation bias. We then analyzed published registries (55022 patients) for allocation of higher-risk patients (Killip class ≥1) to determine whether the choice of reperfusion therapy was affected by the risk level of the patient. Meta-regression was used to examine the relationship between differences in allocation of high-risk patient to primary angioplasty or fibrinolysis and mortality. Initial modeling suggested that registry outcomes are sensitive to allocation bias of high-risk patients. Across the registries, the therapy receiving excess high-risk patients had worse mortality. Unequal distribution of high-risk status accounted for most of the between-registry variance (adjusted R(2)(meta)=83.1%). Accounting for differential allocation of higher-risk patients, primary angioplasty gave 22% lower mortality (odds ratio, 0.78; 95% confidence interval, 0.64-0.97; P=0.029). We derive a formula, called the number needed to abolish, highlighting situations in which comparative effectiveness studies are particularly vulnerable to this bias. In ST-segment elevation myocardial infarction, clinicians' preference for management of a few high-risk patients can shift mortality substantially. Comparative effectiveness research in any disease is vulnerable to this, especially diseases with an immediately identifiable high-risk subgroup that clinicians prefer to allocate to 1 therapy. For this reason, preliminary indications from registry-based comparative effectiveness research should be definitively tested by randomized, controlled trials.

[Surgical treatment of achalasia - endoscopic or laparoscopic? : Proposal for a tailored approach].

PubMed

Rahden, B H A von; Filser, J; Al-Nasser, M; Germer, C-T

2017-03-01

Primary idiopathic achalasia is the most common form of the rare esophageal motility disorders. A curative therapy which restores the normal motility does not exist; however, the therapeutic principle of cardiomyotomy according to Ernst Heller leads to excellent symptom control in the majority of cases. The established standard approach is Heller myotomy through the laparoscopic route (LHM), combined with Dor anterior fundoplication for reflux prophylaxis/therapy. At least four meta-analyses of randomized controlled trials (RCTs) have demonstrated superiority of LHM over pneumatic dilation (PD); therefore, LHM should be used as first line therapy (without prior PD) in all operable patients. Peroral endoscopic myotomy (POEM) is a new alternative approach, which enables Heller myotomy to be performed though the endoscopic submucosal route. The POEM procedure has a low complication rate and also leads to good control of dysphagia but reflux rates can possibly be slightly higher (20-30%). Long-term results of POEM are still scarce and the results of the prospective randomized multicenter trial POEM vs. LHM are not yet available; however, POEM seems to be the preferred treatment option for certain indications. Within the framework of the tailored approach for achalasia management of POEM vs. LHM established in Würzburg, we recommend long-segment POEM for patients with type III achalasia (spasmodic) and other hypercontractile motility disorders and potentially type II achalasia (panesophageal compression) with chest pain as the lead symptom, whereas LHM can also be selected for type I. For sigmoid achalasia, especially with siphon-like transformation of the esophagogastric junction, simultaneous hiatal hernia and epiphrenic diverticula, LHM is still the preferred approach. The choice of the procedure for revisional surgery in case of recurrent dysphagia depends on the suspected mechanism (morphological vs. functional/neuromotor).

Sociopsychological tailoring to address colorectal cancer screening disparities: a randomized controlled trial.

PubMed

Jerant, Anthony; Kravitz, Richard L; Sohler, Nancy; Fiscella, Kevin; Romero, Raquel L; Parnes, Bennett; Tancredi, Daniel J; Aguilar-Gaxiola, Sergio; Slee, Christina; Dvorak, Simon; Turner, Charles; Hudnut, Andrew; Prieto, Francisco; Franks, Peter

2014-01-01

Interventions tailored to sociopsychological factors associated with health behaviors have promise for reducing colorectal cancer screening disparities, but limited research has assessed their impact in multiethnic populations. We examined whether an interactive multimedia computer program (IMCP) tailored to expanded health belief model sociopsychological factors could promote colorectal cancer screening in a multiethnic sample. We undertook a randomized controlled trial, comparing an IMCP tailored to colorectal cancer screening self-efficacy, knowledge, barriers, readiness, test preference, and experiences with a nontailored informational program, both delivered before office visits. The primary outcome was record-documented colorectal cancer screening during a 12-month follow-up period. Secondary outcomes included postvisit sociopsychological factor status and discussion, as well as clinician recommendation of screening during office visits. We enrolled 1,164 patients stratified by ethnicity and language (49.3% non-Hispanic, 27.2% Hispanic/English, 23.4% Hispanic/Spanish) from 26 offices around 5 centers (Sacramento, California; Rochester and the Bronx, New York; Denver, Colorado; and San Antonio, Texas). Adjusting for ethnicity/language, study center, and the previsit value of the dependent variable, compared with control patients, the IMCP led to significantly greater colorectal cancer screening knowledge, self-efficacy, readiness, test preference specificity, discussion, and recommendation. During the followup period, 132 (23%) IMCP and 123 (22%) control patients received screening (adjusted difference = 0.5 percentage points, 95% CI -4.3 to 5.3). IMCP effects did not differ significantly by ethnicity/language. Sociopsychological factor tailoring was no more effective than nontailored information in encouraging colorectal cancer screening in a multiethnic sample, despite enhancing sociopsychological factors and visit behaviors associated with screening. The utility of sociopsychological tailoring in addressing screening disparities remains uncertain.

Randomized controlled trial of a video decision support tool for cardiopulmonary resuscitation decision making in advanced cancer.

PubMed

Volandes, Angelo E; Paasche-Orlow, Michael K; Mitchell, Susan L; El-Jawahri, Areej; Davis, Aretha Delight; Barry, Michael J; Hartshorn, Kevan L; Jackson, Vicki Ann; Gillick, Muriel R; Walker-Corkery, Elizabeth S; Chang, Yuchiao; López, Lenny; Kemeny, Margaret; Bulone, Linda; Mann, Eileen; Misra, Sumi; Peachey, Matt; Abbo, Elmer D; Eichler, April F; Epstein, Andrew S; Noy, Ariela; Levin, Tomer T; Temel, Jennifer S

2013-01-20

Decision making regarding cardiopulmonary resuscitation (CPR) is challenging. This study examined the effect of a video decision support tool on CPR preferences among patients with advanced cancer. We performed a randomized controlled trial of 150 patients with advanced cancer from four oncology centers. Participants in the control arm (n = 80) listened to a verbal narrative describing CPR and the likelihood of successful resuscitation. Participants in the intervention arm (n = 70) listened to the identical narrative and viewed a 3-minute video depicting a patient on a ventilator and CPR being performed on a simulated patient. The primary outcome was participants' preference for or against CPR measured immediately after exposure to either modality. Secondary outcomes were participants' knowledge of CPR (score range of 0 to 4, with higher score indicating more knowledge) and comfort with video. The mean age of participants was 62 years (standard deviation, 11 years); 49% were women, 44% were African American or Latino, and 47% had lung or colon cancer. After the verbal narrative, in the control arm, 38 participants (48%) wanted CPR, 41 (51%) wanted no CPR, and one (1%) was uncertain. In contrast, in the intervention arm, 14 participants (20%) wanted CPR, 55 (79%) wanted no CPR, and 1 (1%) was uncertain (unadjusted odds ratio, 3.5; 95% CI, 1.7 to 7.2; P < .001). Mean knowledge scores were higher in the intervention arm than in the control arm (3.3 ± 1.0 v 2.6 ± 1.3, respectively; P < .001), and 65 participants (93%) in the intervention arm were comfortable watching the video. Participants with advanced cancer who viewed a video of CPR were less likely to opt for CPR than those who listened to a verbal narrative.

[Reduced pain from osteoarthritis in hip joint or knee joint during treatment with calcium ascorbate. A randomized, placebo-controlled cross-over trial in general practice].

PubMed

Jensen, Niels Hertz

2003-06-16

Although vitamin C is essential for the formation of collagen and proteoglycan and has been shown to minimise surgically induced arthritis in guinea pigs, no controlled trial has examined its effect on human osteoarthritis. The trial was a multicenter, double-blind, randomised, placebo-controlled, crossover-trial performed by ten general practitioners. The Declaration of Helsinki and the European guidelines for good clinical practice were strictly followed. One hundred and thirty-three patients with radiographically verified symptomatic osteoarthritis of the hip joints and/or the knee joints were treated with one gram of calcium ascorbate or identically looking placebo tablets. The calcium ascorbate tablets and the placebo tablets should be swallowed daily for 14 +/- 3 days respectively, separated by 7 +/- 3 days wash out. The main outcome measure was difference on the 100 mm visual analog scale (VAS) score for pain in a preselected joint. The secondary outcomes were Lequesne score for function and patient preference. Calculated on an intention-to-treat principle, calcium ascorbate reduced pain significantly compared to placebo (p = 0.0078 by analysis of variance between groups (ANOVA) for difference in VAS, mean difference 4.6 mm (95% CI 1.2-8.0). Similar superiority was found for Lequesne index (p = 0.036, difference 0.56 (95% CI 0.04-1.08) and for patient preference (p = 0.012). The demonstrated effect is less than half as pronounced as commonly reported for NSAID etc. If the finding can be reproduced with a smaller, acceptable intake of vitamin C this would be of importance considering the large prevalence of osteoarthrosis.

Laparoscopic Heller Myotomy and Fundoplication: What Is the Evidence?

PubMed

Rebecchi, Fabrizio; Allaix, Marco E; Schlottmann, Francisco; Patti, Marco G; Morino, Mario

2018-04-01

There is no agreement about the best type of fundoplication to add in patients undergoing laparoscopic Heller myotomy (LHM) for achalasia to reduce the risk of postoperative gastroesophageal reflux. This article reviews the current evidence about the outcomes in achalasia patients undergoing LHM with a partial anterior, a partial posterior, or a total fundoplication. We performed a review of the literature in PubMed/Medline electronic databases, which was evaluated according to the GRADE system. The results of the published randomized controlled trials show with a high level of evidence that the addition of a fundoplication reduces the risk of postoperative abnormal reflux, without impairing the food emptying of the esophagus. LHM with partial fundoplication is considered in most centers worldwide the standard of care for the treatment of patients with achalasia. The current evidence fails to show any significant difference between partial anterior and posterior fundoplication. In the absence of further large randomized controlled trial, the decision of performing an anterior or a posterior wrap is based on the surgeon's experience and preference. The addition of a partial fundoplication to LHM leads to a significantly lower rate of postoperative pathological reflux without impairing the esophageal emptying.

Sleep Disordered Breathing in Patients with Heart Failure: Pathophysiology and Management

PubMed Central

Sharma, Bhavneesh; McSharry, David; Malhotra, Atul

2013-01-01

Opinion statement Sleep disordered breathing (SDB) is common in heart failure patients across the range of ejection fractions and is associated with adverse prognosis. Although effective pharmacologic and device-based treatment of heart failure may reduce the frequency or severity of SDB, heart failure treatment alone may not be adequate to restore normal breathing during sleep. Continuous positive airway pressure (CPAP) is the major treatment for SDB in heart failure, especially if obstructive rather than central sleep apnea (CSA) predominates. Adequate suppression of CSA by PAP is associated with a heart transplant-free survival benefit, although randomized trials are ongoing. Bilevel PAP (BPAP) may be as effective as CPAP in treating SDB and may be preferable over CPAP in patients who experience expiratory pressure discomfort. Adaptive (or auto) servo-ventilation (ASV), which adjusts the PAP depending on the patient’s airflow or tidal volume, may be useful in congestive heart failure patients if CPAP is ineffective. Other therapies that have been proposed for SDB in congestive heart failure include nocturnal oxygen, CO2 administration (by adding dead space), theophylline, and acetazolamide; most of which have not been systematically studied in outcome-based prospective randomized trials. PMID:21894522

Can Genetics Predict Response to Complex Behavioral Interventions? Evidence from a Genetic Analysis of the Fast Track Randomized Control Trial

PubMed Central

Albert, Dustin; Belsky, Daniel W.; Crowley, D. Max; Latendresse, Shawn J.; Aliev, Fazil; Riley, Brien; Sun, Cuie; Dick, Danielle M.; Dodge, Kenneth R.

2014-01-01

Early interventions are a preferred method for addressing behavioral problems in high-risk children, but often have only modest effects. Identifying sources of variation in intervention effects can suggest means to improve efficiency. One potential source of such variation is the genome. We conducted a genetic analysis of the Fast Track Randomized Control Trial, a 10-year-long intervention to prevent high-risk kindergarteners from developing adult externalizing problems including substance abuse and antisocial behavior. We tested whether variants of the glucocorticoid receptor gene NR3C1 were associated with differences in response to the Fast Track intervention. We found that in European-American children, a variant of NR3C1 identified by the single-nucleotide polymorphism rs10482672 was associated with increased risk for externalizing psychopathology in control group children and decreased risk for externalizing psychopathology in intervention group children. Variation in NR3C1 measured in this study was not associated with differential intervention response in African-American children. We discuss implications for efforts to prevent externalizing problems in high-risk children and for public policy in the genomic era. PMID:26106668

Intermittent catheterization with hydrophilic catheters as a treatment of chronic neurogenic urinary retention.

PubMed

Chartier-Kastler, Emmanuel; Denys, Pierre

2011-01-01

Neurogenic bladder can be effectively managed with intermittent catheterization (IC) to improve or restore continence, but there is no consensus on which type of catheter is preferred. Hydrophilic catheters were developed to reduce urethral friction, thereby minimizing trauma and sticking, and making them more acceptable to the patient, and easier and safer to use. The objective of this article was to review the literature on the benefits of hydrophilic catheters in patients with neurogenic bladder. A large body of experimental and observational evidence, including randomized controlled trials, was identified using PubMed. Compared with plastic catheters that have been manually lubricated with gel, hydrophilic catheters reduce urinary tract infection and microhematuria. Hydrophilic catheters are also associated with high levels of patient satisfaction because they are comfortable to use. There is a wealth of evidence, including randomized controlled trials, to support the benefits of hydrophilic catheters in terms of safety and quality of life, especially in men with spinal cord injury. More data are required for spina bifida, multiple sclerosis, and in women. Further research is warranted, especially large-scale and long-term robust comparisons of different types of catheter, and in well-defined and stratified populations. Copyright © 2010 Wiley-Liss, Inc.

Healing of donor site in bone-tendon-bone ACL reconstruction accelerated with plasma rich in growth factors: a randomized clinical trial.

PubMed

Seijas, Roberto; Rius, Marta; Ares, Oscar; García-Balletbó, Montserrat; Serra, Iván; Cugat, Ramón

2015-04-01

To determine whether the use of plasma rich in growth factors accelerates healing of the donor site in bone-tendon-bone anterior cruciate ligament (ACL) reconstruction (patellar graft). The use of the patellar graft presents post-operative problems such as anterior knee pain, which limits its use and leads to preference being taken for alternative grafts. A double-blind, randomized, clinical trial was performed comparing two groups of patients who underwent ACL reconstruction using patellar tendon graft and comparing the use of plasma rich in growth factors at the donor site after graft harvest in terms of local regeneration by ultrasound assessment. The plasma rich in growth factors group shows earlier donor site regeneration in comparison with the control group (2 months earlier), with significant differences in the first 4 months of the follow-up. The application of plasma rich in growth factors shows accelerated tissue regeneration processes with respect to the control group. This fact, together with the previously published with similar conclusions, can create a knowledge basis in order to set out new recovery guidelines following ACL reconstruction. Therapeutic study, Level I.

Clinical trials of medicinal cannabis for appetite-related symptoms from advanced cancer: a survey of preferences, attitudes and beliefs among patients willing to consider participation.

PubMed

Luckett, T; Phillips, J; Lintzeris, N; Allsop, D; Lee, J; Solowij, N; Martin, J; Lam, L; Aggarwal, R; McCaffrey, N; Currow, D; Chye, R; Lovell, M; McGregor, I; Agar, M

2016-11-01

Australian clinical trials are planned to evaluate medicinal cannabis in a range of clinical contexts. To explore the preferences, attitudes and beliefs of patients eligible and willing to consider participation in a clinical trial of medicinal cannabis for poor appetite and appetite-related symptoms from advanced cancer. A cross-sectional anonymous survey was administered from July to December 2015 online and in eight adult outpatient palliative care and/or cancer services. Respondents were eligible if they were ≥18 years, had advanced cancer and poor appetite/taste problems/weight loss and might consider participating in a medicinal cannabis trial. Survey items focused on medicinal rather than recreational cannabis use and did not specify botanical or pharmaceutical products. Items asked about previous medicinal cannabis use and preferences for delivery route and invited comments and concerns. There were 204 survey respondents, of whom 26 (13%) reported prior medicinal cannabis use. Tablets/capsules were the preferred delivery mode (n = 144, 71%), followed by mouth spray (n = 84, 42%) and vaporiser (n = 83, 41%). Explanations for preferences (n = 134) most commonly cited convenience (n = 66; 49%). A total of 82% (n = 168) of respondents indicated that they had no trial-related concerns, but a small number volunteered concerns about adverse effects (n = 14) or wanted more information/advice (n = 8). Six respondents volunteered a belief that cannabis might cure cancer, while two wanted assurance of efficacy before participating in a trial. Justification of modes other than tablets/capsules and variable understanding about cannabis and trials will need addressing in trial-related information to optimise recruitment and ensure that consent is properly informed. © 2016 Royal Australasian College of Physicians.

Sequential and simultaneous choices: testing the diet selection and sequential choice models.

PubMed

Freidin, Esteban; Aw, Justine; Kacelnik, Alex

2009-03-01

We investigate simultaneous and sequential choices in starlings, using Charnov's Diet Choice Model (DCM) and Shapiro, Siller and Kacelnik's Sequential Choice Model (SCM) to integrate function and mechanism. During a training phase, starlings encountered one food-related option per trial (A, B or R) in random sequence and with equal probability. A and B delivered food rewards after programmed delays (shorter for A), while R ('rejection') moved directly to the next trial without reward. In this phase we measured latencies to respond. In a later, choice, phase, birds encountered the pairs A-B, A-R and B-R, the first implementing a simultaneous choice and the second and third sequential choices. The DCM predicts when R should be chosen to maximize intake rate, and SCM uses latencies of the training phase to predict choices between any pair of options in the choice phase. The predictions of both models coincided, and both successfully predicted the birds' preferences. The DCM does not deal with partial preferences, while the SCM does, and experimental results were strongly correlated to this model's predictions. We believe that the SCM may expose a very general mechanism of animal choice, and that its wider domain of success reflects the greater ecological significance of sequential over simultaneous choices.

A feasibility study of predictable and unpredictable surf-like sounds for tinnitus therapy using personal music players.

PubMed

Durai, Mithila; Kobayashi, Kei; Searchfield, Grant D

2018-05-28

To evaluate the feasibility of predictable or unpredictable amplitude-modulated sounds for tinnitus therapy. The study consisted of two parts. (1) An adaptation experiment. Loudness level matches and rating scales (10-point) for loudness and distress were obtained at a silent baseline and at the end of three counterbalanced 30-min exposures (silence, predictable and unpredictable). (2) A qualitative 2-week sound therapy feasibility trial. Participants took home a personal music player (PMP). Part 1: 23 individuals with chronic tinnitus and part 2: seven individuals randomly selected from Part 1. Self-reported tinnitus loudness and annoyance were significantly lower than baseline ratings after acute unpredictable sound exposure. Tinnitus annoyance ratings were also significantly lower than the baseline but the effect was small. The feasibility trial identified that participant preferences for sounds varied. Three participants did not obtain any benefit from either sound. Three participants preferred unpredictable compared to predictable sounds. Some participants had difficulty using the PMP, the average self-report hours of use were low (less <1 h/day). Unpredictable surf-like sounds played using a PMP is a feasible tinnitus treatment. Further work is required to improve the acceptance of the sound and ease of PMP use.

Randomization in clinical trials in orthodontics: its significance in research design and methods to achieve it.

PubMed

Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2011-12-01

Randomization is a key step in reducing selection bias during the treatment allocation phase in randomized clinical trials. The process of randomization follows specific steps, which include generation of the randomization list, allocation concealment, and implementation of randomization. The phenomenon in the dental and orthodontic literature of characterizing treatment allocation as random is frequent; however, often the randomization procedures followed are not appropriate. Randomization methods assign, at random, treatment to the trial arms without foreknowledge of allocation by either the participants or the investigators thus reducing selection bias. Randomization entails generation of random allocation, allocation concealment, and the actual methodology of implementing treatment allocation randomly and unpredictably. Most popular randomization methods include some form of restricted and/or stratified randomization. This article introduces the reasons, which make randomization an integral part of solid clinical trial methodology, and presents the main randomization schemes applicable to clinical trials in orthodontics.

Failure to obtain value enhancement by within-trial contrast in simultaneous and successive discriminations.

PubMed

Arantes, Joana; Grace, Randolph C

2008-02-01

The present research tested the generality of the "work ethic" effect described by Clement, Feltus, Kaiser, and Zentall (2000). In Experiment 1, we trained 10 pigeons on a pair of either simultaneous or successive discriminations. One discrimination followed a high-effort requirement (20 pecks to the center key) and the other followed a low-effort requirement (1 peck). Contrary to Clement et al.'s results, we found that preferences between the S+ and S- stimuli in transfer tests depended on the event that initiated the trial: Pigeons preferred the stimulus from the baseline discrimination whose initiating event was most dissimilar from that preceding the test trial. Preferences were similar but less extreme in the successive condition. In Experiment 2, we investigated whether test preferences depended on the amount of training. A total of 12 pigeons were trained on a pair of simultaneous discriminations, except that test sessions were scheduled after every three baseline sessions. Preferences increased across test sessions but were similar to those in Experiment 1. Together with Vasconcelos, Urcuioli, and Lionello-DeNolf (2007a), our study represents a second failure to replicate Clement et al.'s work ethic effect. The finding that preference depends on the event that initiates the test trial suggests that choice probes may not provide unambiguous assessments of stimulus value.

A Systematic Review of Randomized Controlled Trials Examining the Effectiveness of Saffron (Crocus sativus L.) on Psychological and Behavioral Outcomes

PubMed Central

Hausenblas, Heather Ann; Heekin, Kacey; Mutchie, Heather Lee; Anton, Stephen

2017-01-01

Introduction Throughout the past three decades, increased scientific attention has been given to examining saffron’s (Crocus sativus L.) use as a potential therapeutic or preventive agent for a number of health conditions, including cancer, cardiovascular disease, and depression. Saffron has been shown to improve numerous health-related physiological to psychological outcomes. The purpose of this systematic review is to examine and categorize the current state of scientific evidence from randomized controlled trials (RCTs) regarding the efficacy of saffron on psychological and behavioral outcomes. Methods Electronic and non-electronic systematic searches were conducted to identify all relevant human clinical research on saffron. The search strategy was extensive and was designed according to the “Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)”. Reference lists of articles that met the inclusion criteria were searched. Only English language studies were reviewed. Results Twelve studies met our inclusion criteria. These studies examined the effects of saffron on psychological/behavioral outcomes with respect to the following health conditions: major depressive disorder (n = 6), premenstrual syndrome (n = 1), sexual dysfunction and infertility (n = 4), and weight loss/snacking behaviors (n = 1). The data from these studies support the efficacy of saffron in improving: depressive symptoms, premenstrual symptoms, sexual function, and satiety. Conclusion Findings from initial clinical trials suggest that saffron can improve the symptoms and effects of depression, premenstrual syndrome, sexual dysfunction and infertility, and excessive snacking behaviors. Larger multi-site clinical trials are needed to extend these preliminary findings. PMID:26165367

Effectiveness of balneotherapy and spa therapy for the treatment of chronic low back pain: a review on latest evidence.

PubMed

Karagülle, Mine; Karagülle, Müfit Zeki

2015-02-01

In most European countries, balneotherapy and spa therapy are widely prescribed by physicians and preferred by European citizens for the treatment of musculoskeletal problems including chronic low back pain (LBP). We aimed to review and evaluate the recent evidence on the effectiveness of balneotherapy and spa therapy for patients with LBP. We comprehensively searched data bases for randomized controlled trials (RCTs) published in English between July 2005 and December 2013. We identified all trials testing balneotherapy or spa therapy for LBP that reported that the sequence of allocation was randomized. We finally included total of eight RCTs: two on balneotherapy and six on spa therapy. All reviewed trials reported that balneotherapy was superior in long term to tap water therapy in relieving pain and improving function and that spa therapy combining balneotherapy with mud pack therapy and/or exercise therapy, physiotherapy, and/or education was effective in the management of low back pain and superior or equally effective to the control treatments in short and long terms. We used Jadad scale to grade the methodological quality. Only three out of total eight had a score of above 3 indicating the good quality. The data from the RCTs indicates that overall evidence on effectiveness of balneotherapy and spa therapy in LBP is encouraging and reflects the consistency of previous evidence. However, the overall quality of trials is generally low. Better quality RCTs (well designed, conducted, and reported) are needed testing short- and long-term effects for relieving chronic back pain and proving broader beneficial effects.

Effect of Minimalist Footwear on Running Efficiency: A Randomized Crossover Trial.

PubMed

Gillinov, Stephen M; Laux, Sara; Kuivila, Thomas; Hass, Daniel; Joy, Susan M

2015-05-01

Although minimalist footwear is increasingly popular among runners, claims that minimalist footwear enhances running biomechanics and efficiency are controversial. Minimalist and barefoot conditions improve running efficiency when compared with traditional running shoes. Randomized crossover trial. Level 3. Fifteen experienced runners each completed three 90-second running trials on a treadmill, each trial performed in a different type of footwear: traditional running shoes with a heavily cushioned heel, minimalist running shoes with minimal heel cushioning, and barefoot (socked). High-speed photography was used to determine foot strike, ground contact time, knee angle, and stride cadence with each footwear type. Runners had more rearfoot strikes in traditional shoes (87%) compared with minimalist shoes (67%) and socked (40%) (P = 0.03). Ground contact time was longest in traditional shoes (265.9 ± 10.9 ms) when compared with minimalist shoes (253.4 ± 11.2 ms) and socked (250.6 ± 16.2 ms) (P = 0.005). There was no difference between groups with respect to knee angle (P = 0.37) or stride cadence (P = 0.20). When comparing running socked to running with minimalist running shoes, there were no differences in measures of running efficiency. When compared with running in traditional, cushioned shoes, both barefoot (socked) running and minimalist running shoes produce greater running efficiency in some experienced runners, with a greater tendency toward a midfoot or forefoot strike and a shorter ground contact time. Minimalist shoes closely approximate socked running in the 4 measurements performed. With regard to running efficiency and biomechanics, in some runners, barefoot (socked) and minimalist footwear are preferable to traditional running shoes.

Evidence for the use of parenteral nutrition in the pediatric intensive care unit.

PubMed

Fivez, Tom; Kerklaan, Dorian; Mesotten, Dieter; Verbruggen, Sascha; Joosten, Koen; Van den Berghe, Greet

2017-02-01

During hospitalization in a pediatric intensive care unit (PICU), critically ill children are fed artificially. Administered via the preferred enteral route, caloric targets are often not reached. Hence, parenteral nutrition is given to this patient population. In this review we analyzed the available evidence from randomized controlled trials (RCTs) that supports the use of parenteral nutrition in children during critical illness. A search strategy in Ovid MEDLINE and Ovid EMBASE was created and trial registries were screened to identify the relevant RCTs. Studies were included if they were randomized controlled trials, involved pediatric patients admitted to PICU, and compared different dosing/compositions of parenteral nutrition. Descriptive studies and reviews were excluded. Of the 584 articles identified by the search strategy, only 114 articles were retained after title screening. Further abstract and full text screening identified 6 small RCTs that compared two dosing/composition strategies of parenteral nutrition. These trials reported differences in surrogate endpoints without an effect on hard clinical endpoints. The RCTs observed improvements in these surrogate endpoints with the use of more calories or when parenteral glutamine or fish oil was added. The few RCTs suggest that surrogate endpoints can be affected by providing parenteral nutrition to critically ill children, but the studies were not statistically powered to draw meaningful clinical conclusions. Large RCTs with clinically relevant outcome measures are urgently needed to support the current nutritional guidelines that advise the use of parenteral nutrition in the PICU. Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Complementary and alternative medicine for rheumatic diseases: A systematic review of randomized controlled trials.

PubMed

Phang, Jie Kie; Kwan, Yu Heng; Goh, Hendra; Tan, Victoria Ie Ching; Thumboo, Julian; Østbye, Truls; Fong, Warren

2018-04-01

To summarize all good quality randomized controlled trials (RCTs) using complementary and alternative medicine (CAM) interventions in patients with rheumatic diseases. A systematic literature review guided by the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) was performed. We excluded non-English language articles and abstract-only publications. Due to the large number of RCTs identified, we only include "good quality" RCTs with Jadad score of five. We identified 60 good quality RCTs using CAM as intervention for patients with rheumatic diseases: acupuncture (9), Ayurvedic treatment (3), homeopathic treatment (3), electricity (2), natural products (31), megavitamin therapies (8), chiropractic or osteopathic manipulation (3), and energy healing therapy (1). The studies do not seem to suggest a particular type of CAM is effective for all types for rheumatic diseases. However, some CAM interventions appear to be more effective for certain types of rheumatic diseases. Acupuncture appears to be beneficial for osteoarthritis but not rheumatoid arthritis. For the other therapeutic modalities, the evidence base either contains too few trials or contains trials with contradictory findings which preclude any definitive summary. There were only minor adverse reactions observed for CAM interventions presented. We identified 60 good quality RCTs which were heterogenous in terms of interventions, disease, measures used to assess outcomes, and efficacy of CAM interventions. Evidence indicates that some CAM therapies may be useful for rheumatic diseases, such as acupuncture for osteoarthritis. Further research with larger sample size is required for more conclusive evidence regarding efficacy of CAM interventions. Copyright © 2018 Elsevier Ltd. All rights reserved.

Relations among Spontaneous Preferences, Familiarized Preferences, and Novelty Effects: Measurements with Forced-Choice Techniques

ERIC Educational Resources Information Center

Civan, Andrea; Teller, Davida Y.; Palmer, John

2005-01-01

We here describe a discrete trial, forced-choice, combined spontaneous preference and novelty preference technique. In this technique, spontaneous preferences and familiarized (postfamiliarization) preferences are measured with the same stimulus pairs under closely parallel conditions. A variety of systematic stimulus variations were used in…

The effect of information about the benefits and harms of mammography on women's decision-making: study protocol for a randomized controlled trial.

PubMed

Carles, Misericòrdia; Martínez-Alonso, Montserrat; Pons, Anna; Pérez-Lacasta, Maria José; Perestelo-Pérez, Lilisbeth; Sala, Maria; Vidal, Carmen; Garcia, Montse; Toledo-Chávarri, Ana; Codern, Núria; Feijoo-Cid, Maria; Romero, Anabel; Pla, Roger; Soler-González, Jorge; Castells, Xavier; Rué, Montserrat

2017-09-12

The decision to participate or not in breast cancer screening is complex due to the trade-off between the expected benefit of breast cancer mortality reduction and the major harm of overdiagnosis. It seems ethically necessary to inform women so that they can actively participate in decision-making and make an informed choice based on their values and preferences. The objective of this study is to assess the effects of receiving information about the benefits and harms of screening on decision-making, in women approaching the age of invitation to mammography screening. A two-stage, randomized controlled trial (RCT). In the first stage, 40 Basic Health Areas (BHAs) will be selected and randomized to intervention or control. In the second stage, women within each BHA will be randomly selected (n = 400). Four breast cancer screening programs (BCSPs) of the Spanish public health system, three in Catalonia and one in the Canary Islands will participate in the study. Women in the intervention arm will receive a leaflet with detailed information on the benefits and harms of screening using mammography. Women in the control arm will receive a standard leaflet that does not mention harms and recommends accepting the invitation to participate in the biennial examinations of the BCSP. The primary outcome is informed choice, a dichotomous variable that combines knowledge, attitudes, and intentions. Secondary outcomes include decisional conflict; confidence in the decision made; anxiety about screening participation; worry about breast cancer; anticipated regret; time perspective; perceived importance of benefits/harms of screening; perceived risk of breast cancer; and leaflet acceptability. Primary and secondary outcomes are assessed 2-3 weeks after the intervention. This is the first RCT that assesses the effect of informing about the benefits and harms of breast cancer screening in Spain in women facing the decision to be screened using mammography. It aims to assess the impact of information on several decisional outcomes and to contribute to paving the road towards shared decision-making in breast cancer screening in our country. ClinicalTrials.gov registry, ID: NCT03046004 . Retrospectively registered on 4 February 2017. Trial name: InforMa study.

A Randomized Comparison of Aripiprazole and Risperidone for the Acute Treatment of First-Episode Schizophrenia and Related Disorders: 3-Month Outcomes

PubMed Central

Robinson, Delbert G.; Gallego, Juan A.; John, Majnu; Petrides, Georgios; Hassoun, Youssef; Zhang, Jian-Ping; Lopez, Leonardo; Braga, Raphael J.; Sevy, Serge M.; Addington, Jean; Kellner, Charles H.; Tohen, Mauricio; Naraine, Melissa; Bennett, Natasha; Greenberg, Jessica; Lencz, Todd; Correll, Christoph U.; Kane, John M.; Malhotra, Anil K.

2015-01-01

Research findings are particularly important for medication choice for first-episode patients as individual prior medication response to guide treatment decisions is unavailable. We describe the first large-scale double-masked randomized comparison with first-episode patients of aripiprazole and risperidone, 2 commonly used first-episode treatment agents. One hundred ninety-eight participants aged 15–40 years with schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder Not Otherwise Specified, and who had been treated in their lifetime with antipsychotics for 2 weeks or less were randomly assigned to double-masked aripiprazole (5–30mg/d) or risperidone (1–6mg/d) and followed for 12 weeks. Positive symptom response rates did not differ (62.8% vs 56.8%) nor did time to response. Aripiprazole-treated participants had better negative symptom outcomes but experienced more akathisia. Body mass index change did not differ between treatments but advantages were found for aripiprazole treatment for total and low-density lipoprotein cholesterol, fasting glucose, and prolactin levels. Post hoc analyses suggested advantages for aripiprazole on depressed mood. Overall, if the potential for akathisia is a concern, low-dose risperidone as used in this trial maybe a preferred choice over aripiprazole. Otherwise, aripiprazole would be the preferred choice over risperidone in most situations based upon metabolic outcome advantages and some symptom advantages within the context of similar positive symptom response between medications. PMID:26338693

A Randomized Clinical Trial of the Effect of the Time of Administration of Cloprostenol on Detention of Estrus in Dairy Cattle

PubMed Central

Hodges, Richard J.; White, Maurice E.; Guard, Charles L.; Powers, Pamela M.; Dinsmore, R. Page; Kelton, David F.; Stehman, Susan M.; Hillman, Robert B.; Yoder, Samuel S.

1988-01-01

We performed a clinical trial to study whether cows with palpable corpora lutea treated with cloprostenol by the farmer on the morning following examination (median time 0630 hours) were seen in heat and conceived more frequently than cows treated by the veterinarian immediately following the reproductive examination (median time 1210 hours). There were no significant differences between the two groups in the proportions of cows seen in estrus or fertility at the induced estrus. The proportions of animals that had the time of onset of estrus recorded and were seen in estrus during working hours (0800-1600 hours) were also not significantly different between the veterinary-treated and farmer-treated groups. Under the conditions of this study, there was no reason to prefer prescribing early morning administration of cloprostenol by farmers over immediate administration of the drug by the clinician. PMID:17423022

Factors associated with choice of a low-fat or low-carbohydrate diet during a behavioral weight loss intervention☆, ☆☆

PubMed Central

McVay, Megan A.; Voils, Corrine I.; Coffman, Cynthia J.; Geiselman, Paula J.; Kolotkin, Ronette L.; Mayer, Stephanie B.; Smith, Valerie A.; Gaillard, Leslie; Turner, Marsha J.; Yancy, William S.

2016-01-01

Individuals undertaking a weight loss effort have a choice among proven dietary approaches. Factors contributing to choice of either a low-fat/low-calorie diet or a low-carbohydrate diet, two of the most studied and popular dietary approaches, are unknown. The current study used data from participants randomized to the ‘choice’ arm of a trial examining whether being able to choose a diet regimen yields higher weight loss than being randomly assigned to a diet. At study entry, participants attended a group session during which they were provided tailored feedback indicating which diet was most consistent with their food preferences using the Geiselman Food Preference Questionnaire (FPQ), information about both diets, and example meals for each diet. One week later, they indicated which diet they chose to follow during the 48-week study, with the option of switching diets after 12 weeks. Of 105 choice arm participants, 44 (42%) chose the low-fat/low-calorie diet and 61 (58%) chose the low-carbohydrate diet. In bivariate analyses, diet choice was not associated with age, race, sex, education, BMI, or diabetes (all p > 0.05). Low-carbohydrate diet choice was associated with baseline higher percent fat intake (p = 0.007), lower percent carbohydrate intake (p = 0.02), and food preferences consistent with a low-carbohydrate diet according to FPQ (p < 0.0001). In a multivariable logistic regression model, only FPQ diet preference was associated with diet choice (p = 0.001). Reported reasons for diet choice were generally similar for those choosing either diet; however, concerns about negative health effects of the unselected diet was rated as more influential among participants selecting the low-fat diet. Only three low-carbohydrate and two low-fat diet participants switched diets at 12 weeks. Results suggest that when provided a choice between two popular weight loss dietary approaches, an individual's selection is likely influenced by baseline dietary intake pattern, and especially by his or her dietary preferences. Research is needed to determine if congruency between food preferences and dietary approach is associated with weight loss. PMID:25149197

Factors associated with choice of a low-fat or low-carbohydrate diet during a behavioral weight loss intervention.

PubMed

McVay, Megan A; Voils, Corrine I; Coffman, Cynthia J; Geiselman, Paula J; Kolotkin, Ronette L; Mayer, Stephanie B; Smith, Valerie A; Gaillard, Leslie; Turner, Marsha J; Yancy, William S

2014-12-01

Individuals undertaking a weight loss effort have a choice among proven dietary approaches. Factors contributing to choice of either a low-fat/low-calorie diet or a low-carbohydrate diet, two of the most studied and popular dietary approaches, are unknown. The current study used data from participants randomized to the 'choice' arm of a trial examining whether being able to choose a diet regimen yields higher weight loss than being randomly assigned to a diet. At study entry, participants attended a group session during which they were provided tailored feedback indicating which diet was most consistent with their food preferences using the Geiselman Food Preference Questionnaire (FPQ), information about both diets, and example meals for each diet. One week later, they indicated which diet they chose to follow during the 48-week study, with the option of switching diets after 12 weeks. Of 105 choice arm participants, 44 (42%) chose the low-fat/low-calorie diet and 61 (58%) chose the low-carbohydrate diet. In bivariate analyses, diet choice was not associated with age, race, sex, education, BMI, or diabetes (all p > 0.05). Low-carbohydrate diet choice was associated with baseline higher percent fat intake (p = 0.007), lower percent carbohydrate intake (p = 0.02), and food preferences consistent with a low-carbohydrate diet according to FPQ (p < 0.0001). In a multivariable logistic regression model, only FPQ diet preference was associated with diet choice (p = 0.001). Reported reasons for diet choice were generally similar for those choosing either diet; however, concerns about negative health effects of the unselected diet was rated as more influential among participants selecting the low-fat diet. Only three low-carbohydrate and two low-fat diet participants switched diets at 12 weeks. Results suggest that when provided a choice between two popular weight loss dietary approaches, an individual's selection is likely influenced by baseline dietary intake pattern, and especially by his or her dietary preferences. Research is needed to determine if congruency between food preferences and dietary approach is associated with weight loss. Published by Elsevier Ltd.

Is using multiple imputation better than complete case analysis for estimating a prevalence (risk) difference in randomized controlled trials when binary outcome observations are missing?

PubMed

Mukaka, Mavuto; White, Sarah A; Terlouw, Dianne J; Mwapasa, Victor; Kalilani-Phiri, Linda; Faragher, E Brian

2016-07-22

Missing outcomes can seriously impair the ability to make correct inferences from randomized controlled trials (RCTs). Complete case (CC) analysis is commonly used, but it reduces sample size and is perceived to lead to reduced statistical efficiency of estimates while increasing the potential for bias. As multiple imputation (MI) methods preserve sample size, they are generally viewed as the preferred analytical approach. We examined this assumption, comparing the performance of CC and MI methods to determine risk difference (RD) estimates in the presence of missing binary outcomes. We conducted simulation studies of 5000 simulated data sets with 50 imputations of RCTs with one primary follow-up endpoint at different underlying levels of RD (3-25 %) and missing outcomes (5-30 %). For missing at random (MAR) or missing completely at random (MCAR) outcomes, CC method estimates generally remained unbiased and achieved precision similar to or better than MI methods, and high statistical coverage. Missing not at random (MNAR) scenarios yielded invalid inferences with both methods. Effect size estimate bias was reduced in MI methods by always including group membership even if this was unrelated to missingness. Surprisingly, under MAR and MCAR conditions in the assessed scenarios, MI offered no statistical advantage over CC methods. While MI must inherently accompany CC methods for intention-to-treat analyses, these findings endorse CC methods for per protocol risk difference analyses in these conditions. These findings provide an argument for the use of the CC approach to always complement MI analyses, with the usual caveat that the validity of the mechanism for missingness be thoroughly discussed. More importantly, researchers should strive to collect as much data as possible.

Does packaging with a calendar feature improve adherence to self-administered medication for long-term use? A systematic review.

PubMed

Zedler, Barbara K; Kakad, Priyanka; Colilla, Susan; Murrelle, Lenn; Shah, Nirav R

2011-01-01

The therapeutic benefit of self-administered medications for long-term use is limited by an average 50% nonadherence rate. Patient forgetfulness is a common factor in unintentional nonadherence. Unit-of-use packaging that incorporates a simple day-and-date feature (calendar packaging) is designed to improve adherence by prompting patients to maintain the prescribed dosing schedule. To review systematically, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement, randomized controlled trial evidence of the adherence benefits and harms of calendar blister packaging (CBP) and calendar pill organizers (CPO) for self-administered, long-term medication use. Data sources included the MEDLINE and Web of Science and Cochrane Library databases from their inception to September 2010 and communication with researchers in the field. Key search terms included blister-calendar pack, blister pack, drug packaging, medication adherence, medication compliance, medication compliance devices, medication containers, medication organizers, multicompartment compliance aid, persistence, pill-box organizers, prescription refill, randomized controlled trials, and refill compliance. Selected studies had an English-language title; a randomized controlled design; medication packaged in CBP or CPO; a requirement of solid, oral medication self-administered daily for longer than 1 month in community-dwelling adults; and at least 1 quantitative outcome measure of adherence. Two reviewers extracted data independently on study design, sample size, type of intervention and control, and outcomes. Ten trials with a total of 1045 subjects met the inclusion criteria, and 9 also examined clinical outcomes (seizures, blood pressure, psychiatric symptoms) or health care resource utilization. Substantial heterogeneity among trials precluded meta-analysis. In 3 studies, calendar packaging was part of a multicomponent adherence intervention. Six of 10 trials reported higher adherence, but it was associated with clinically significant improvement in only 1 study: 50% decreased seizure frequency with a CPO-based, multicomponent intervention. No study reported sufficient information to examine conclusively potential harms related to calendar packaging. All trials had significant methodological limitations, such as inadequate randomization or blinding, or reported insufficient information regarding enrolled subjects and attrition, which resulted in a moderate-to-high risk of bias and, in 2 studies, unevaluable outcome data. Trials were generally short and sample sizes small, with heterogeneous adherence outcome measures. Calendar packaging, especially in combination with education and reminder strategies, may improve medication adherence. Methodological limitations preclude definitive conclusions about the effect size of adherence and clinical benefits or harms associated with CBP and CPO. High-quality trials of adequate size and duration are needed to assess the clinical effectiveness of such interventions. Copyright © 2011 Elsevier HS Journals, Inc. All rights reserved.

Ethical acceptability of offering financial incentives for taking antipsychotic depot medication: patients' and clinicians' perspectives after a 12-month randomized controlled trial.

PubMed

Noordraven, Ernst L; Schermer, Maartje H N; Blanken, Peter; Mulder, Cornelis L; Wierdsma, André I

2017-08-29

A randomized controlled trial 'Money for Medication'(M4M) was conducted in which patients were offered financial incentives for taking antipsychotic depot medication. This study assessed the attitudes and ethical considerations of patients and clinicians who participated in this trial. Three mental healthcare institutions in secondary psychiatric care in the Netherlands participated in this study. Patients (n = 169), 18-65 years, diagnosed with schizophrenia, schizoaffective disorder or another psychotic disorder who had been prescribed antipsychotic depot medication, were randomly assigned to receive 12 months of either treatment as usual plus a financial reward for each depot of medication received (intervention group) or treatment as usual alone (control group). Structured questionnaires were administered after the 12-month intervention period. Data were available for 133 patients (69 control and 64 intervention) and for 97 clinicians. Patients (88%) and clinicians (81%) indicated that financial incentives were a good approach to improve medication adherence. Ethical concerns were categorized according to the four-principles approach (autonomy, beneficence, non-maleficence, and justice). Patients and clinicians alike mentioned various advantages of M4M in clinical practice, such as increased medication adherence and improved illness insight; but also disadvantages such as reduced intrinsic motivation, loss of autonomy and feelings of dependence. Overall, patients evaluated financial incentives as an effective method of improving medication adherence and were willing to accept this reward during clinical treatment. Clinicians were also positive about the use of this intervention in daily practice. Ethical concerns are discussed in terms of patient autonomy, beneficence, non-maleficence and justice. We conclude that this intervention is ethically acceptable under certain conditions, and that further research is necessary to clarify issues of benefit, motivation and the preferred size and duration of the incentive. Nederlands Trial Register, number NTR2350 .

Evaluation of the UP4FUN Intervention: A Cluster Randomized Trial to Reduce and Break Up Sitting Time in European 10-12-Year-Old Children

PubMed Central

Vik, Frøydis N.; Lien, Nanna; Berntsen, Sveinung; De Bourdeaudhuij, Ilse; Grillenberger, Monika; Manios, Yannis; Kovacs, Eva; Chinapaw, Mai J. M.; Brug, Johannes; Bere, Elling

2015-01-01

Background The UP4FUN intervention is a family-involved school-based intervention aiming at reducing and breaking up sitting time at home (with special emphasis on screen time), and breaking up sitting time in school among 10–12 year olds in Europe. The purpose of the present paper was to evaluate its short term effects. Methodology/Principal Findings A total of 3147 pupils from Belgium, Germany, Greece, Hungary and Norway participated in a school-randomized controlled trial. The intervention included 1–2 school lessons per week for a period of six weeks, along with assignments for the children and their parents. Screen time and breaking up sitting time were registered by self-report and total sedentary time and breaking up sitting time by accelerometry. The effect of the intervention on these behaviors was evaluated by multilevel regression analyses. All analyses were adjusted for baseline values and gender. Significance level was p≤0.01. No significant intervention effects were observed, neither for self-reported TV/DVD or computer/game console time, nor for accelerometer-assessed total sedentary time and number of breaks in sitting time. The intervention group, however, reported more positive attitudes towards (β = 0.25 (95% CI 0.11, 0.38)) and preferences/liking for (β = 0.20 (95% CI 0.08, 0.32)) breaking up sitting time than the control group. Conclusions/Significance No significant intervention effect on self-reported screen time or accelerometer-assessed sedentary time or breaks in sitting time was observed, but positive effects on beliefs regarding breaking up sitting time were found in favor of the intervention group. Overall, these results do not warrant wider dissemination of the present UP4FUN intervention. Trial Registration International Standard Randomized Controlled Trial Number Registry ISRCTN34562078 PMID:25826704

Knowledge translation on dementia: a cluster randomized trial to compare a blended learning approach with a "classical" advanced training in GP quality circles

PubMed Central

Vollmar, Horst C; Butzlaff, Martin E; Lefering, Rolf; Rieger, Monika A

2007-01-01

Background Thus far important findings regarding the dementia syndrome have been implemented into patients' medical care only inadequately. A professional training accounting for both, general practitioners' (GP) needs and learning preferences as well as care-relevant aspects could be a major step towards improving medical care. In the WIDA-study, entitled "Knowledge translation on dementia in general practice" two different training concepts are developed, implemented and evaluated. Both concepts are building on an evidence-based, GP-related dementia guideline and communicate the guideline's essential insights. Methods/Design Both development and implementation emphasize a procedure that is well-accepted in practice and, thus, can achieve a high degree of external validity. This is particularly guaranteed through the preparation of training material and the fact that general practitioners' quality circles (QC) are addressed. The evaluation of the two training concepts is carried out by comparing two groups of GPs to which several quality circles have been randomly assigned. The primary outcome is the GPs' knowledge gain. Secondary outcomes are designed to indicate the training's potential effects on the GPs' practical actions. In the first training concept (study arm A) GPs participate in a structured case discussion prepared for by internet-based learning material ("blended-learning" approach). The second training concept (study arm B) relies on frontal medical training in the form of a slide presentation and follow-up discussion ("classical" approach). Discussion This paper presents the outline of a cluster-randomized trial which has been peer reviewed and support by a national funding organization – Federal Ministry of Education and Research (BMBF) – and is approved by an ethics commission. The data collection has started in August 2006 and the results will be published independently of the study's outcome. Trial Registration Current Controlled Trials [ISRCTN36550981] PMID:17587452

Meta-analyses of mood stabilizers, antidepressants and antipsychotics in the treatment of borderline personality disorder: effectiveness for depression and anger symptoms.

PubMed

Mercer, Deanna; Douglass, Alan B; Links, Paul S

2009-04-01

The objective of our study was to complete separate meta-analyses of randomized controlled trials of mood stabilizers, antidepressants and antipsychotics to determine whether these medications are efficacious for depression and anger symptoms in borderline personality disorder (BPD). Studies were obtained from OVID Medline, Cochrane Central Register of Controlled Trials, and PsychInfo. References of all original papers and reviews were searched for additional studies. Index terms included: BPD, randomized controlled trials, drug therapy, medication, and treatment. Studies were included if they were randomized double-blind placebo-controlled trials, published in a peer reviewed journal, had a majority of patients with BPD or included patients with BPD where anger was a target of treatment. Preference was given to studies using outcome measures that were well known, validated, objective, and based on intent-to-treat data. Where available, measures of anger that incorporated verbal and other indirect forms of aggression were utilized. The StatsDirect meta-analysis program was used to calculate an effect size and 95% confidence interval for each study. Mood stabilizers, with the exception of divalproic acid, were found to have a large pooled effect size (-1.75, 95% CI = -2.77 to -0.74) for anger. Divalproic acid and carbamazepine had a moderate effect on depression. Antidepressants had a moderate effect on anger reduction, but a small effect on depression. Antipsychotics had a moderate effect on anger; however aripiprazole had a much larger effect-size than other antipsychotics. Antipsychotics did not have an effect for depression. Sources of variation between studies included length of treatment (5-24 weeks), drop out rates (5% to 65%), proportion of patients in psychotherapy (0-100%) and with comorbid mood disorders (0-100%). Unfortunately most studies excluded patients with alcohol and substance abuse, suicidality, and self-harm behaviors. This may limit the ability to generalize our findings to usual clinical practice.

Mixed-treatment comparison of anabolic (teriparatide and PTH 1-84) therapies in women with severe osteoporosis.

PubMed

Migliore, A; Broccoli, S; Massafra, U; Bizzi, E; Frediani, B

2012-03-01

The recent development of compounds with anabolic action on bone have increased the range of therapeutic options for the treatment of osteoporosis and the prevention of fractures. Two major PTH analogs, the synthetic full-length 1-84 PTH molecule and the recombinant 1-34 N-terminal fragment (teriparatide), are available for the treatment of osteoporosis in many countries. There have bee no comparative trials on the bone anabolic effects of these compounds. In this study we applied a mixed treatment comparison (MTC) to compare the efficacy of teriparatide versus PTH 1-84 for the prevention of vertebral and non-vertebral fractures in women with severe osteoporosis. With this approach the relative treatment effect of one intervention over another can be obtained in the absence of head-to-head comparison. Among the candidate papers selected for analysis, two randomized controlled trials investigating the effects of teriparatide and PTH 1-84 met the selection criteria and underwent MTC analysis. Based on a fixed-effect MTC model analysis of data from two RCTs, teriparatide (20 µg/day) showed a 70% and 94% probability of being the best treatment for the prevention of vertebral and non-vertebral fractures, respectively. Together with a lack of statistical significance, this study has additional limitations. Some differences in trial procedures and populations exist; another limitation concerns the impossibility of carrying out a randomized-effect model MTC, due to sample exiguity. Furthermore, in order to consider unknown or unmeasured differences of covariates across trials, a random-effects approach would be preferred in order to assess the presence of heterogeneity across comparisons. In contrast, in our analysis a fixed-effect MTC model only was used. Teriparatide is expected to provide a greater efficacy over PTH 1-84 with both vertebral and non-vertebral fracture prevention in postmenopausal women with severe osteoporosis.

MRI signal intensity of anterior cruciate ligament graft after transtibial versus anteromedial portal technique (TRANSIG): design of a randomized controlled clinical trial.

PubMed

Ruiter, Simeon J S; Brouwer, Reinoud W; Meys, Tim W G M; Slump, Cornelis H; van Raay, Jos J A M

2016-08-10

There are two primary surgical techniques to reconstruct the anterior cruciate ligament (ACL), transtibial (TT) technique and anteromedial portal (AMP) technique. Currently, there is no consensus which surgical technique elicits the best clinical and functional outcomes. MRI-derived measures of the signal intensity (SI) of the ACL graft have been described as an independent predictor of graft properties. The purpose of this study is to compare the MRI derived SI measurements of the ACL graft one year after ACL reconstruction, in order to compare the outcomes of both the AMP and TT ACL reconstruction technique. Thirty-six patients will be included in a randomized controlled trial. Patients who are admitted for primary unilateral ACL reconstruction will be included in the study. Exclusion criteria are a history of previous surgery on the ipsilateral knee, re-rupture of the ipsilateral ACL graft, associated ligamentous injuries or meniscal tear of the ipsilateral knee, unhealthy contralateral knee, contra-indications for MRI and a preference for one of the two surgical techniques and/or orthopaedic surgeon. Primary outcome is MRI Signal intensity ratio (SIR) of the ACL graft. Secondary outcome measures are the International Knee Documentation Committee (IKDC) Knee Examination Form,the Knee injury and Osteoarthritis Outcome Scores (KOOS) and the Anterior Cruciate Ligament OsteoArthritis Score (ACLOAS). Differences between MRI SIR assessment with the current MRI protocol (proton density weighted imaging protocol) and the additional T2*-weighted gradient-echo protocol will be assessed. There is no consensus regarding the TT or AMP ACL reconstruction technique. SI measurements with MRI have been used in other clinical studies for evaluation of the ACL graft and maturation after ACL reconstruction compared to clinical and functional outcomes. This randomized controlled trial has been designed to compare the TT technique with the AMP technique with the use of MRI SI of the graft after ACL reconstruction. Netherlands Trial Registry NTR5410 (registered on August 24, 2015).

The Efficacy of Mindfulness-Based Interventions in Primary Care: A Meta-Analytic Review.

PubMed

Demarzo, Marcelo M P; Montero-Marin, Jesús; Cuijpers, Pim; Zabaleta-del-Olmo, Edurne; Mahtani, Kamal R; Vellinga, Akke; Vicens, Caterina; López-del-Hoyo, Yolanda; García-Campayo, Javier

2015-11-01

Positive effects have been reported after mindfulness-based interventions (MBIs) in diverse clinical and nonclinical populations. Primary care is a key health care setting for addressing common chronic conditions, and an effective MBI designed for this setting could benefit countless people worldwide. Meta-analyses of MBIs have become popular, but little is known about their efficacy in primary care. Our aim was to investigate the application and efficacy of MBIs that address primary care patients. We performed a meta-analytic review of randomized controlled trials addressing the effect of MBIs in adult patients recruited from primary care settings. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and Cochrane guidelines were followed. Effect sizes were calculated with the Hedges g in random effects models. The meta-analyses were based on 6 trials having a total of 553 patients. The overall effect size of MBI compared with a control condition for improving general health was moderate (g = 0.48; P = .002), with moderate heterogeneity (I(2) = 59; P <.05). We found no indication of publication bias in the overall estimates. MBIs were efficacious for improving mental health (g = 0.56; P = .007), with a high heterogeneity (I(2) = 78; P <.01), and for improving quality of life (g = 0.29; P = .002), with a low heterogeneity (I(2) = 0; P >.05). Although the number of randomized controlled trials applying MBIs in primary care is still limited, our results suggest that these interventions are promising for the mental health and quality of life of primary care patients. We discuss innovative approaches for implementing MBIs, such as complex intervention and stepped care. © 2015 Annals of Family Medicine, Inc.

Changes in balance, functional performance and fall risk following whole body vibration training and vitamin D supplementation in institutionalized elderly women. A 6 month randomized controlled trial.

PubMed

Bogaerts, An; Delecluse, Christophe; Boonen, Steven; Claessens, Albrecht L; Milisen, Koen; Verschueren, Sabine M P

2011-03-01

Falls in the elderly constitute a growing public health problem. This randomized controlled trial investigated the potential benefit of 6 months of whole body vibration (WBV) training and/or vitamin D supplementation on balance, functionality and estimated fall risk in institutionalized elderly women. A total of 113 women (mean age: 79.6) were randomly assigned to either a WBV or a no-training group, receiving either a conventional dose (880 IU/d) or a high dose (1600 IU/d) of vitamin D3. The WBV group performed exercises on a vibration platform 3×/week. Balance was evaluated by computerized posturography. Functionality was assessed by 10 m walk test, Timed up and Go (TUG) performance and endurance capacity (Shuttle Walk). Fall risk was determined with the Physiological Profile Assessment. Performance on the 10 m walk test and on TUG improved over time in all groups. For none of the parameters, high-dose vitamin D resulted in a better performance than conventional dosing. The improvements in the WBV group in endurance capacity, walking at preferred speed, and TUG were significantly larger than the changes with supplementation alone. No additional benefit of WBV training could be detected on fall risk and postural control, although sway velocity and maximal isometric knee extension strength improved only in the WBV group. This trial showed that a high-dose vitamin D supplementation is not more efficient than conventional dosing in improving functionality in institutionalized elderly. WBV training on top of vitamin D supplementation provided an added benefit with regard to walking, TUG performance, and endurance capacity. Copyright © 2010 Elsevier B.V. All rights reserved.

Low-Molecular-Weight Heparin and the Relative Risk of Surgical Site Bleeding Complications: Results of a Systematic Review and Meta-Analysis of Randomized Controlled Trials of Venous Thromboprophylaxis in Patients After Total Joint Arthroplasty.

PubMed

Suen, Kary; Westh, Roger N; Churilov, Leonid; Hardidge, Andrew J

2017-09-01

Venous thromboembolism causes significant morbidity and mortality in patients after total joint arthroplasty. Although network meta-analyses have demonstrated a benefit of various thromboprophylactic agents, there remains a concern in the surgical community regarding the resulting wound complications. There is currently no systematic review of the surgical site bleeding complications of thromboprophylactic agents. The aim of this study was to systematically review the surgical site bleeding outcomes of venous thromboembolism prophylaxis in this population. A systematic review and meta-analysis was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Randomized controlled trials comparing more than one of low-molecular-weight heparin (LMWH), warfarin, rivaroxaban, apixaban, dabigatran, aspirin, or no pharmacologic treatment in patients after total hip or knee arthroplasty were selected for inclusion. Five meta-analyses were performed to compare LMWH with control, warfarin, apixaban, rivaroxaban, and dabigatran. Forty-five randomized controlled trials of 56,730 patients were included. LMWH had a significantly increased relative risk of surgical site bleeding in comparison with control (relative risk, 2.32; 95% confidence interval, 1.40-3.85) and warfarin (1.54; 1.23-1.94). The relative risk of LMWH trended higher than apixaban (1.27; 1.00-1.63) and was similar to rivaroxaban (0.95; 0.74-1.23). Only 1 study reported the risk of surgical site bleeding in LMWH vs dabigatran (5.97; 2.08-17.11). LMWH increased the risk of surgical site bleeding compared with control, warfarin. and dabigatran and trended toward an increased risk compared with apixaban. The risk of surgical site bleeding was similar with LMWH and rivaroxaban. Copyright © 2017 Elsevier Inc. All rights reserved.

Effects of standard training in the use of closed-circuit televisions in visually impaired adults: design of a training protocol and a randomized controlled trial

PubMed Central

2010-01-01

Background Reading problems are frequently reported by visually impaired persons. A closed-circuit television (CCTV) can be helpful to maintain reading ability, however, it is difficult to learn how to use this device. In the Netherlands, an evidence-based rehabilitation program in the use of CCTVs was lacking. Therefore, a standard training protocol needed to be developed and tested in a randomized controlled trial (RCT) to provide an evidence-based training program in the use of this device. Methods/Design To develop a standard training program, information was collected by studying literature, observing training in the use of CCTVs, discussing the content of the training program with professionals and organizing focus and discussion groups. The effectiveness of the program was evaluated in an RCT, to obtain an evidence-based training program. Dutch patients (n = 122) were randomized into a treatment group: normal instructions from the supplier combined with training in the use of CCTVs, or into a control group: instructions from the supplier only. The effect of the training program was evaluated in terms of: change in reading ability (reading speed and reading comprehension), patients' skills to operate the CCTV, perceived (vision-related) quality of life and tasks performed in daily living. Discussion The development of the CCTV training protocol and the design of the RCT in the present study may serve as an example to obtain an evidence-based training program. The training program was adjusted to the needs and learning abilities of individual patients, however, for scientific reasons it might have been preferable to standardize the protocol further, in order to gain more comparable results. Trial registration http://www.trialregister.nl, identifier: NTR1031 PMID:20219120

Efficacy and safety of the glycine transporter-1 inhibitor org 25935 for the prevention of relapse in alcohol-dependent patients: a randomized, double-blind, placebo-controlled trial.

PubMed

de Bejczy, Andrea; Nations, Kari R; Szegedi, Armin; Schoemaker, Joep; Ruwe, Frank; Söderpalm, Bo

2014-09-01

Org 25935 is a glycine transporter inhibitor that increases extracellular glycine levels and attenuates alcohol-induced dopaminergic activity in the nucleus accumbens. In animal models, Org 25935 has dose-dependent effects on ethanol intake, preference, and relapse-like behavior without tolerance. The current study aimed to translate these animal findings to humans by examining whether Org 25935 prevents relapse in detoxified alcohol-dependent patients. This was a multicenter, randomized, double-blind, placebo-controlled clinical trial. Adult patients diagnosed with alcohol dependence were randomly assigned to receive Org 25935 12 mg twice a day or placebo for 84 days. The primary end point was percentage heavy drinking days (defined as ≥ 5 standard drinks per day for men and ≥ 4 for women). Secondary end points included other measures of relapse-related drinking behavior (e.g., drinks per day, time to relapse), as well as measures of global functioning, alcohol-related thoughts and cravings, and motivation. A total of 140 subjects were included in the intent-to-treat analysis. The trial was stopped approximately midway after a futility analysis showing that the likelihood of detecting a signal at study term was <40%. There was no significant difference between Org 25935 and placebo on percentage heavy drinking days or any other measure of relapse-related drinking behavior. Org 25935 showed no safety issues and was fairly well tolerated, with fatigue, dizziness, and transient visual events as the most commonly occurring side effects. Org 25935 demonstrated no benefit over placebo in preventing alcohol relapse. Study limitations and implications are discussed. Copyright © 2014 by the Research Society on Alcoholism.

Knowledge translation on dementia: a cluster randomized trial to compare a blended learning approach with a "classical" advanced training in GP quality circles.

PubMed

Vollmar, Horst C; Butzlaff, Martin E; Lefering, Rolf; Rieger, Monika A

2007-06-22

Thus far important findings regarding the dementia syndrome have been implemented into patients' medical care only inadequately. A professional training accounting for both, general practitioners' (GP) needs and learning preferences as well as care-relevant aspects could be a major step towards improving medical care. In the WIDA-study, entitled "Knowledge translation on dementia in general practice" two different training concepts are developed, implemented and evaluated. Both concepts are building on an evidence-based, GP-related dementia guideline and communicate the guideline's essential insights. Both development and implementation emphasize a procedure that is well-accepted in practice and, thus, can achieve a high degree of external validity. This is particularly guaranteed through the preparation of training material and the fact that general practitioners' quality circles (QC) are addressed. The evaluation of the two training concepts is carried out by comparing two groups of GPs to which several quality circles have been randomly assigned. The primary outcome is the GPs' knowledge gain. Secondary outcomes are designed to indicate the training's potential effects on the GPs' practical actions. In the first training concept (study arm A) GPs participate in a structured case discussion prepared for by internet-based learning material ("blended-learning" approach). The second training concept (study arm B) relies on frontal medical training in the form of a slide presentation and follow-up discussion ("classical" approach). This paper presents the outline of a cluster-randomized trial which has been peer reviewed and support by a national funding organization--Federal Ministry of Education and Research (BMBF)--and is approved by an ethics commission. The data collection has started in August 2006 and the results will be published independently of the study's outcome. Current Controlled Trials [ISRCTN36550981].

The Efficacy of Mindfulness-Based Interventions in Primary Care: A Meta-Analytic Review

PubMed Central

Demarzo, Marcelo M.P.; Montero-Marin, Jesús; Cuijpers, Pim; Zabaleta-del-Olmo, Edurne; Mahtani, Kamal R.; Vellinga, Akke; Vicens, Caterina; López-del-Hoyo, Yolanda; García-Campayo, Javier

2015-01-01

PURPOSE Positive effects have been reported after mindfulness-based interventions (MBIs) in diverse clinical and nonclinical populations. Primary care is a key health care setting for addressing common chronic conditions, and an effective MBI designed for this setting could benefit countless people worldwide. Meta-analyses of MBIs have become popular, but little is known about their efficacy in primary care. Our aim was to investigate the application and efficacy of MBIs that address primary care patients. METHODS We performed a meta-analytic review of randomized controlled trials addressing the effect of MBIs in adult patients recruited from primary care settings. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and Cochrane guidelines were followed. Effect sizes were calculated with the Hedges g in random effects models. RESULTS The meta-analyses were based on 6 trials having a total of 553 patients. The overall effect size of MBI compared with a control condition for improving general health was moderate (g = 0.48; P = .002), with moderate heterogeneity (I2 = 59; P <.05). We found no indication of publication bias in the overall estimates. MBIs were efficacious for improving mental health (g = 0.56; P = .007), with a high heterogeneity (I2 = 78; P <.01), and for improving quality of life (g = 0.29; P = .002), with a low heterogeneity (I2 = 0; P >.05). CONCLUSIONS Although the number of randomized controlled trials applying MBIs in primary care is still limited, our results suggest that these interventions are promising for the mental health and quality of life of primary care patients. We discuss innovative approaches for implementing MBIs, such as complex intervention and stepped care. PMID:26553897

The Sexunzipped trial: young people's views of participating in an online randomized controlled trial.

PubMed

Nicholas, Angela; Bailey, Julia V; Stevenson, Fiona; Murray, Elizabeth

2013-12-12

Incidence of sexually transmitted infections (STIs) among young people in the United Kingdom is increasing. The Internet can be a suitable medium for delivery of sexual health information and sexual health promotion, given its high usage among young people, its potential for creating a sense of anonymity, and ease of access. Online randomized controlled trials (RCTs) are increasingly being used to evaluate online interventions, but while there are many advantages to online methodologies, they can be associated with a number of problems, including poor engagement with online interventions, poor trial retention, and concerns about the validity of data collected through self-report online. We conducted an online feasibility trial that tested the effects of the Sexunzipped website for sexual health compared to an information-only website. This study reports on a qualitative evaluation of the trial procedures, describing participants' experiences and views of the Sexunzipped online trial including methods of recruitment, incentives, methods of contact, and sexual health outcome measurement. Our goal was to determine participants' views of the acceptability and validity of the online trial methodology used in the pilot RCT of the Sexunzipped intervention. We used three qualitative data sources to assess the acceptability and validity of the online pilot RCT methodology: (1) individual interviews with 22 participants from the pilot RCT, (2) 133 emails received by the trial coordinator from trial participants, and (3) 217 free-text comments from the baseline and follow-up questionnaires. Interviews were audio-recorded and transcribed verbatim. An iterative, thematic analysis of all three data sources was conducted to identify common themes related to the acceptability and feasibility of the online trial methodology. Interview participants found the trial design, including online recruitment via Facebook, online registration, email communication with the researchers, and online completion of sexual health questionnaires to be highly acceptable and preferable to traditional methods. Incentives might assist in recruiting those who would not otherwise participate. Participants generally enjoyed taking part in sexual health research online and found the questionnaire itself thought-provoking. Completing the sexual health questionnaires online encouraged honesty in responding that might not be achieved with other methods. The majority of interview participants also thought that receiving and returning a urine sample for chlamydia testing via post was acceptable. These findings provide strong support for the use of online research methods for sexual health research, emphasizing the importance of careful planning and execution of all trial procedures including recruitment, respondent validation, trial related communication, and methods to maximize follow-up. Our findings suggest that sexual health outcome measurement might encourage reflection on current behavior, sometimes leading to behavior change. International Standard Randomized Controlled Trial Number (ISRCTN): 55651027; http://www.controlled-trials.com/isrctn/pf/55651027 (Archived by WebCite at http://www.webcitation.org/6LbkxdPKf).

Public preferences on written informed consent for low‐risk pragmatic clinical trials in Spain

PubMed Central

Carcas, Antonio J.; Carné, Xavier; Wendler, David

2017-01-01

Aims Pragmatic randomized clinical trials (pRCTs) collect data that have the potential to improve medical care significantly. However, these trials may be undermined by the requirement to obtain written informed consent, which can decrease accrual and increase selection bias. Recent data suggest that the majority of the US public endorses written consent for low‐risk pRCTs. The present study was designed to assess whether this view is specific to the US. Methods The study took the form of a cross‐sectional, probability‐based survey, with a 2 × 2 factorial design, assessing support for written informed consent vs. verbal consent or general notification for two low‐risk pRCTs in hypertension, one comparing two drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night. The primary outcome measures were respondents' personal preference and hypothetical recommendation to a research ethics committee regarding the use of written informed consent vs. the alternatives. Results A total of 2008 adults sampled from a probability‐based online panel responded to the web‐based survey conducted in May 2016 (response rate: 61%). Overall, 77% of respondents endorsed written consent. In both scenarios, the alternative of general notification received significantly more support (28.7–37.1%) than the alternative of verbal consent (12.7–14.0%) (P = 0.001). Forty per cent of respondents preferred and/or recommended general notification rather than written consent. Conclusions The results suggested that, rather than attempting to waive written consent, current pRCTs should focus on developing ways to implement written consent that provide sufficient information without undermining recruitment or increasing selection bias. The finding that around 40% of respondents endorsed general notification over written consent raises the possibility that, with educational efforts, the majority of Spaniards might accept general notification for low‐risk pRCTs. PMID:28419518

Methodological quality of randomized trials published in the Journal of the American Podiatric Medical Association, 1999-2013.

PubMed

Landorf, Karl B; Menz, Hylton B; Armstrong, David G; Herbert, Robert D

2015-07-01

Randomized trials must be of high methodological quality to yield credible, actionable findings. The main aim of this project was to evaluate whether there has been an improvement in the methodological quality of randomized trials published in the Journal of the American Podiatric Medical Association (JAPMA). Randomized trials published in JAPMA during a 15-year period (January 1999 to December 2013) were evaluated. The methodological quality of randomized trials was evaluated using the PEDro scale (scores range from 0 to 10, with 0 being lowest quality). Linear regression was used to assess changes in methodological quality over time. A total of 1,143 articles were published in JAPMA between January 1999 and December 2013. Of these, 44 articles were reports of randomized trials. Although the number of randomized trials published each year increased, there was only minimal improvement in their methodological quality (mean rate of improvement = 0.01 points per year). The methodological quality of the trials studied was typically moderate, with a mean ± SD PEDro score of 5.1 ± 1.5. Although there were a few high-quality randomized trials published in the journal, most (84.1%) scored between 3 and 6. Although there has been an increase in the number of randomized trials published in JAPMA, there is substantial opportunity for improvement in the methodological quality of trials published in the journal. Researchers seeking to publish reports of randomized trials should seek to meet current best-practice standards in the conduct and reporting of their trials.

Manipulation Detection and Preference Alterations in a Choice Blindness Paradigm

PubMed Central

Taya, Fumihiko; Gupta, Swati; Farber, Ilya; Mullette-Gillman, O'Dhaniel A.

2014-01-01

Objectives It is commonly believed that individuals make choices based upon their preferences and have access to the reasons for their choices. Recent studies in several areas suggest that this is not always the case. In choice blindness paradigms, two-alternative forced-choice in which chosen-options are later replaced by the unselected option, individuals often fail to notice replacement of their chosen option, confabulate explanations for why they chose the unselected option, and even show increased preferences for the unselected-but-replaced options immediately after choice (seconds). Although choice blindness has been replicated across a variety of domains, there are numerous outstanding questions. Firstly, we sought to investigate how individual- or trial-factors modulated detection of the manipulations. Secondly, we examined the nature and temporal duration (minutes vs. days) of the preference alterations induced by these manipulations. Methods Participants performed a computerized choice blindness task, selecting the more attractive face between presented pairs of female faces, and providing a typewritten explanation for their choice on half of the trials. Chosen-face cue manipulations were produced on a subset of trials by presenting the unselected face during the choice explanation as if it had been selected. Following all choice trials, participants rated the attractiveness of each face individually, and rated the similarity of each face pair. After approximately two weeks, participants re-rated the attractiveness of each individual face online. Results Participants detected manipulations on only a small proportion of trials, with detections by fewer than half of participants. Detection rates increased with the number of prior detections, and detection rates subsequent to first detection were modulated by the choice certainty. We show clear short-term modulation of preferences in both manipulated and non-manipulated explanation trials compared to choice-only trials (with opposite directions of effect). Preferences were altered in the direction that subjects were led to believe they selected. PMID:25247886

Impact of red versus blue light on tolerability and efficacy of PDT: a randomized controlled trial.

PubMed

Gholam, Patrick; Bosselmann, Ina; Enk, Alexander; Fink, Christine

2018-06-01

Various light sources may be used for photodynamic therapy of actinic keratosis since photosensitizing agents are activated by different wavelengths. However, the relative impact of red and blue light irradiation on the efficacy and tolerability of therapy is controversial. The aim of this study is to compare the efficacy and tolerability of therapy with red versus blue light sources, as well as the patients' evaluation of cosmetic results, clinical response, painfulness and preferred light source for future photodynamic treatments. This is a prospective, single-center, randomized, controlled, open-label study with 28 patients undergoing elective photodynamic therapy. Red and blue light sources both showed very good results with a complete response rate of 84 % and 85 % respectively. Pain during photodynamic therapy was 6.1 vs. 5.4 (and 2.1 vs. 1.5 eight hours after therapy) on the visual analogue scale. Although these differences were statistically significant, the clinical relevance is low, since the number of therapy interruptions were equally distributed in both groups, and patients' subjective evaluation of the treatment showed no personal preference towards the light sources. Both light sources showed very good clinical results and satisfactory tolerability in this study. © 2018 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd.

Prospective randomized trial of iohexol 350 versus meglumine sodium diatrizoate as an oral contrast agent for abdominopelvic computed tomography.

PubMed

Peterson, Christine M; Lin, Michael; Pilgram, Thomas; Heiken, Jay P

2011-01-01

To compare the efficacy and patient tolerance of iohexol and meglumine sodium diatrizoate as oral contrast agents for computed tomography (CT). One hundred patients were randomly assigned to drink 1000 mL of either meglumine sodium diatrizoate or iohexol 350 before their abdominopelvic CT examination. The images were evaluated independently and in a blinded fashion by 2 radiologists who scored the extent and density of bowel opacification. Attenuation value measurements were obtained in representative areas of each gastrointestinal tract segment (stomach, duodenum, jejunum, ileum, and colon) by a research technologist. Patients' tolerance of the oral contrast agent was assessed through a questionnaire administered immediately after the CT and with a follow-up phone call 2 to 3 days later. For most of the bowel, there was no statistically significant difference in the extent or degree of opacification between the 2 contrast agents. Opacification of the ileum was better with iohexol. There was no statistically significant difference between the 2 agents in adverse effects. Patients had a small but statistically significant preference for the taste of iohexol. Iohexol 350 is a satisfactory oral contrast agent for abdominopelvic CT. It opacifies the gastrointestinal tract as well as meglumine sodium diatrizoate does, and patients prefer the taste of iohexol to that of diatrizoate.

Improvement the Yoghurt Nutritional Value, Organoleptic Properties and Preferences by Spirulina (Spirulina platensis) Supplementation

NASA Astrophysics Data System (ADS)

Suzery, M.; Hadiyanto; Sutanto, H.; Widiastuti, Y.; Judiono

2018-04-01

Spirulina sp has been identified as potential source food functional such as protein, amino acids and other high added value compounds from microalgae. One of the compounds is phycocyanin as also known for antioxidant use. This research was aimed to increase the nutritional value and organoleptic properties and preferences yoghurt by Spirulina platensis supplementation. Completely randomized controlled group design conducted by 31 respondents. Spirulina Research accomplished in Food Technology, Microbiology and Chemistry Laboratory at Bandung Health Polytechnic in Bandung. Samples divided randomly into three groups: (1) yoghurt standard supplemented 50 ml, (2) yoghurt and spirulina 1% supplemented 50 ml, (3) yoghurt and spirulina 1,2% supplemented 50 ml. Spirulina was added concentration by 0, 1, 1,2 % calculated by dx trial. Proximate analysis revealed the highest protein in enriched by spirulina 1%. However fat was lower 3.48 – 3.56 compare to control. All products found growing Lactobacillus acidophilus with a pH of 4.0 range. There was no microbial contamination such as E coli, Salmonella sp, Pseudomonas sp. Supplementation of spirulina to yoghurt products can be accepted by organoleptic, chemical and microbiological tests of concentrations of 1 and 1.2%. The material makes the blue colours more attractive and can be accepted by the expert panellist.

Acceptability and willingness to pay for primary care videoconferencing: a randomized controlled trial.

PubMed

Stahl, James E; Dixon, Ronald F

2010-01-01

We examined videoconferencing in comparison with face-to-face office visits in primary care. Four physicians took part in the study and 175 patients were recruited from a general medical practice. Patients were interviewed and examined in both face-to-face and virtual settings, the order being randomized. Patients and clinicians were surveyed by questionnaire after each visit. Physicians were very satisfied with videoconferencing but preferred face-to-face overall (P < 0.0001). For videoconferencing, the physical examination and the ability to order appropriate laboratory tests were the least satisfying elements of the encounter. Patients were also very satisfied with videoconferencing but overall preferred face-to-face (P < 0.0001). This difference was significant for gastrointestinal, musculoskeletal and respiratory complaints. However, in terms of willingness to pay (WTP) for videoconferencing access, patients with musculoskeletal and respiratory complaints were the most willing. Age and gender did not significantly predict WTP. The technical quality of the videoconference had a significant effect on satisfaction with the clinical encounter but did not correlate with the patients' WTP for videoconferencing. Travel costs up to $40 and travel times up to 4 hours did not influence the WTP of patients. For non-rural, relatively mobile patients, videoconferencing appears suitable for short visits for relatively simple complaints.

Balloon catheter versus basket catheter for endoscopic bile duct stone extraction: a multicenter randomized trial.

PubMed

Ishiwatari, Hirotoshi; Kawakami, Hiroshi; Hisai, Hiroyuki; Yane, Kei; Onodera, Manabu; Eto, Kazunori; Haba, Shin; Okuda, Toshinori; Ihara, Hideyuki; Kukitsu, Takehiro; Matsumoto, Ryusuke; Kitaoka, Keisuke; Sonoda, Tomoko; Hayashi, Tsuyoshi

2016-04-01

Endoscopic bile duct stone (BDS) removal is a well-established treatment; however, the preference for basket or balloon catheters for extraction is operator-dependent. We therefore conducted a multicenter prospective randomized trial to compare catheter performance. We enrolled patients with a BDS diameter ≤ 10 mm and common bile duct diameter ≤ 15 mm. Participants were randomly assigned to groups that were treated with basket or balloon catheters between October 2013 and September 2014. The primary endpoint was the rate of complete clearance of the duct; the secondary endpoints were the rate and time to complete clearance in one endoscopic session. We initially enrolled 172 consecutive patients; 14 were excluded after randomization. The complete clearance rates were 92.3 % (72/78) in the balloon group and 80.0 % (64 /80) in the basket group. The difference in the rates between the two groups was 12.3 percentage points, indicating non-inferiority of the balloon method (non-inferiority limit -10 %; P < 0.001 for non-inferiority). Moreover, the balloon was superior to the basket (P = 0.037). The rate of complete clearance in one endoscopic session was 97.4 % using the balloon and 97.5 % using the basket (P = 1.00). The median times to complete clearance in one endoscopic session were 6.0 minutes (1 - 30) and 7.8 minutes (1 - 37) in the balloon and basket groups, respectively (P = 0.15). For extraction of BDSs ≤ 10 mm, complete endoscopic treatment with a single catheter is more likely when choosing a balloon catheter over a basket catheter.University Hospital Medical Information Network Trials Registry: UMIN000011887. © Georg Thieme Verlag KG Stuttgart · New York.

Dismantling Multicomponent Behavioral Treatment for Insomnia in Older Adults: A Randomized Controlled Trial

PubMed Central

Epstein, Dana R.; Sidani, Souraya; Bootzin, Richard R.; Belyea, Michael J.

2012-01-01

Study Objective: Recently, the use of multicomponent insomnia treatment has increased. This study compares the effect of single component and multicomponent behavioral treatments for insomnia in older adults after intervention and at 3 months and 1 yr posttreatment. Design: A randomized, controlled study. Setting: Veterans Affairs medical center. Participants: 179 older adults (mean age, 68.9 yr ± 8.0; 115 women [64.2%]) with chronic primary insomnia. Interventions: Participants were randomly assigned to 6 wk of stimulus control therapy (SCT), sleep restriction therapy (SRT), the 2 therapies combined into a multicomponent intervention (MCI), or a wait-list control group. Measurements and Results: Primary outcomes were subjective (daily sleep diary) and objective (actigraphy) measures of sleep-onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TIB), and sleep efficiency (SE). Secondary outcomes were clinical measures including response and remission rates. There were no differences between the single and multicomponent interventions on primary sleep outcomes measured by diary and actigraphy. All treatments produced significant improvement in diary-reported sleep in comparison with the control group. Effect sizes for sleep diary outcomes were medium to large. Treatment gains were maintained at follow-up for diary and actigraph measured SOL, WASO, and SE. The MCI group had the largest proportion of treatment remitters. Conclusions: For older adults with chronic primary insomnia, the findings provide initial evidence that SCT, SRT, and MCI are equally efficacious and produce sustainable treatment gains on diary, actigraphy, and clinical outcomes. From a clinical perspective, MCI may be a preferred treatment due to its higher remission rate. Clinical Trial Information: Behavioral Intervention for Insomnia in Older Adults. NCT01154023. URL: http://clinicaltrials.gov/ct2/show/NCT01154023?term=Behavioral+Intervention+for+Insomnia+in+Older+Adults&rank=1. Citation: Epstein DR; Sidani S; Bootzin RR; Belyea MJ. Dismantling multicomponent behavioral treatment for insomnia in older adults: a randomized controlled trial. SLEEP 2012;35(6):797-805. PMID:22654199

Study protocol: systematic review and meta-analysis of randomized controlled trials in first-line treatment of squamous non-small cell lung cancer

PubMed Central

2014-01-01

Background There is a high unmet need for effective treatments for patients with squamous non-small cell lung cancer (NSCLC). Eli Lilly and Company is conducting a phase III, randomized, multicenter, open-label study of gemcitabine plus cisplatin plus necitumumab (GC + N) versus gemcitabine plus cisplatin (GC) for the first-line treatment of patients with stage IV squamous NSCLC. Given GC is not the only treatment commonly used for the treatment of squamous NSCLC, this study was designed to compare the survival, toxicity, and quality of life outcomes of current treatment strategies for squamous NSCLC in the first-line setting. Methods/Design A systematic review and meta-analysis (including indirect comparisons) of treatments used in squamous NSCLC will be conducted to assess the clinical efficacy (overall and progression-free survival), health-related quality of life (HRQoL), and safety (grade 3–4 toxicity) of GC + N compared to other treatments used in squamous NSCLC. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines will be followed for all aspects of this study. A systematic literature review will be conducted to identify randomized controlled trials evaluating chemotherapy treatment in first-line NSCLC. Eligible articles will be restricted to randomized controlled trials (RCTs) among chemotherapy-naïve advanced NSCLC cancer patients that report outcome data (survival, toxicity, or quality of life) for patients with squamous histology. Following data extraction and validation, data consistency and study heterogeneity will be assessed. A network meta-analysis will be conducted based on the available hazard ratios for overall and progression-free survival, odds ratios for published toxicity data, and mean difference of HRQoL scales. Sensitivity analyses will be conducted. Discussion This is a presentation of the study protocol only. Results and conclusions are pending completion of this study. Systematic review registration PROSPERO CRD42014008968 PMID:25227571

Lipid profile changes after pomegranate consumption: A systematic review and meta-analysis of randomized controlled trials.

PubMed

Sahebkar, Amirhossein; Simental-Mendía, Luis E; Giorgini, Paolo; Ferri, Claudio; Grassi, Davide

2016-10-15

Transport of oxidized low-density lipoprotein across the endothelium into the artery wall is considered a fundamental priming step for the atherosclerotic process. Recent studies reported potential therapeutic effects of micronutrients found in natural products, indicating positive applications for controlling the pathogenesis of chronic cardiovascular disease driven by cardiovascular risk factors and oxidative stress. A particular attention has been recently addressed to pomegranate; however findings of clinical studies have been contrasting. To evaluate the effects of pomegranate consumption on plasma lipid concentrations through a systematic review and meta-analysis of randomized controlled trials (RCTs). The study was designed according to the preferred reporting items for systematic reviews and meta-analysis (PRISMA) statement. Scopus and Medline databases were searched to identify randomized placebo-controlled trials investigating the impact of pomegranate on plasma lipid concentrations. A fixed-effects model and the generic inverse variance method were used for quantitative data synthesis. Sensitivity analysis was conducted using the one-study remove approach. Random-effects meta-regression was performed to assess the impact of potential confounders on the estimated effect sizes. A total of 545 individuals were recruited from the 12 RCTs. Fixed-effect meta-analysis of data from 12 RCTs (13 treatment arms) did not show any significant effect of pomegranate consumption on plasma lipid concentrations. The results of meta-regression did not suggest any significant association between duration of supplementation and impact of pomegranate on total cholesterol and HDL-C, while an inverse association was found with changes in triglycerides levels (slope: -1.07; 95% CI: -2.03 to -0.11; p = 0.029). There was no association between the amount of pomegranate juice consumed per day and respective changes in plasma total cholesterol, LDL-C, HDL-C and triglycerides. The present meta-analysis of RCTs did not suggest any effect of pomegranate consumption on lipid profile in human. Copyright © 2016. Published by Elsevier GmbH.

Anxiety status affects nicotine- and baclofen-induced locomotor activity, anxiety, and single-trial conditioned place preference in male adolescent rats.

PubMed

Falco, Adriana M; McDonald, Craig G; Smith, Robert F

2014-09-01

Adolescents have an increased vulnerability to nicotine and anxiety may play a role in the development of nicotine abuse. One possible treatment for anxiety disorders and substance abuse is the GABAB agonist, baclofen. The aim of the present study was to determine the effect of anxiety-like behavior on single-trial nicotine conditioned place preference in adolescent rats, and to assess the action of baclofen. Baclofen was shown to have effects on locomotor and anxiety-like behavior in rats divided into high-anxiety and low-anxiety groups. Baclofen decreased locomotor behavior in high-anxiety rats. Baclofen alone failed to produce differences in anxiety-like behavior, but nicotine and baclofen + nicotine administration were anxiolytic. High- and low-anxiety groups also showed differences in single-trial nicotine-induced place preference. Only high-anxiety rats formed place preference to nicotine, while rats in the low-anxiety group formed no conditioned place preference. These results suggest that among adolescents, high-anxiety individuals are more likely to show preference for nicotine than low-anxiety individuals. © 2014 Wiley Periodicals, Inc.

Randomized controlled trial comparing esophageal dilation to no dilation among adults with esophageal eosinophilia and dysphagia.

PubMed

Kavitt, R T; Ates, F; Slaughter, J C; Higginbotham, T; Shepherd, B D; Sumner, E L; Vaezi, M F

2016-11-01

The role of esophageal dilation in patients with esophageal eosinophilia with dysphagia remains unknown. The practice of dilation is currently based on center preferences and expert opinion. The aim of this study is to determine if, and to what extent, dysphagia improves in response to initial esophageal dilation followed by standard medical therapies. We conducted a randomized, blinded, controlled trial evaluating adult patients with dysphagia and newly diagnosed esophageal eosinophilia from 2008 to 2013. Patients were randomized to dilation or no dilation at time of endoscopy and blinded to dilation status. Endoscopic features were graded as major and minor. Subsequent to randomization and endoscopy, all patients received fluticasone and dexlansoprazole for 2 months. The primary study outcome was reduction in overall dysphagia score, assessed at 30 and 60 days post-intervention. Patients with severe strictures (less than 7-mm esophageal diameter) were excluded from the study. Thirty-one patients were randomized and completed the protocol: 17 randomized to dilation and 14 to no dilation. Both groups were similar with regard to gender, age, eosinophil density, endoscopic score, and baseline dysphagia score. The population exhibited moderate to severe dysphagia and moderate esophageal stricturing at baseline. Overall, there was a significant (P < 0.001) but similar reduction in mean dysphagia score at 30 and 60 days post-randomization compared with baseline in both groups. No significant difference in dysphagia scores between treatment groups after 30 (P = 0.93) or 60 (P = 0.21) days post-intervention was observed. Esophageal dilation did not result in additional improvement in dysphagia score compared with treatment with proton pump inhibitor and fluticasone alone. In patients with symptomatic esophageal eosinophilia without severe stricture, dilation does not appear to be a necessary initial treatment strategy. © 2015 International Society for Diseases of the Esophagus.

Regression discontinuity was a valid design for dichotomous outcomes in three randomized trials.

PubMed

van Leeuwen, Nikki; Lingsma, Hester F; Mooijaart, Simon P; Nieboer, Daan; Trompet, Stella; Steyerberg, Ewout W

2018-06-01

Regression discontinuity (RD) is a quasi-experimental design that may provide valid estimates of treatment effects in case of continuous outcomes. We aimed to evaluate validity and precision in the RD design for dichotomous outcomes. We performed validation studies in three large randomized controlled trials (RCTs) (Corticosteroid Randomization After Significant Head injury [CRASH], the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries [GUSTO], and PROspective Study of Pravastatin in elderly individuals at risk of vascular disease [PROSPER]). To mimic the RD design, we selected patients above and below a cutoff (e.g., age 75 years) randomized to treatment and control, respectively. Adjusted logistic regression models using restricted cubic splines (RCS) and polynomials and local logistic regression models estimated the odds ratio (OR) for treatment, with 95% confidence intervals (CIs) to indicate precision. In CRASH, treatment increased mortality with OR 1.22 [95% CI 1.06-1.40] in the RCT. The RD estimates were 1.42 (0.94-2.16) and 1.13 (0.90-1.40) with RCS adjustment and local regression, respectively. In GUSTO, treatment reduced mortality (OR 0.83 [0.72-0.95]), with more extreme estimates in the RD analysis (OR 0.57 [0.35; 0.92] and 0.67 [0.51; 0.86]). In PROSPER, similar RCT and RD estimates were found, again with less precision in RD designs. We conclude that the RD design provides similar but substantially less precise treatment effect estimates compared with an RCT, with local regression being the preferred method of analysis. Copyright © 2018 Elsevier Inc. All rights reserved.

Ethics in the use of extracorporeal cardiopulmonary resuscitation in adults.

PubMed

Riggs, Kevin R; Becker, Lance B; Sugarman, Jeremy

2015-06-01

Extracorporeal cardiopulmonary resuscitation (ECPR) promises to be an important advance in the treatment of cardiac arrest. However, ECPR involves ethical challenges that should be addressed as it diffuses into practice. Benefits and risks are uncertain, so the evidence base needs to be further developed, at least through outcomes registries and potentially with randomized trials. To inform decision making, patients' preferences regarding ECPR should be obtained, both from the general population and from inpatients at risk for cardiac arrest. Fair and transparent appropriate use criteria should be developed and could be informed by economic analyses. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Statistical innovations in the medical device world sparked by the FDA.

PubMed

Campbell, Gregory; Yue, Lilly Q

2016-01-01

The world of medical devices while highly diverse is extremely innovative, and this facilitates the adoption of innovative statistical techniques. Statisticians in the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) have provided leadership in implementing statistical innovations. The innovations discussed include: the incorporation of Bayesian methods in clinical trials, adaptive designs, the use and development of propensity score methodology in the design and analysis of non-randomized observational studies, the use of tipping-point analysis for missing data, techniques for diagnostic test evaluation, bridging studies for companion diagnostic tests, quantitative benefit-risk decisions, and patient preference studies.

Optimism bias leads to inconclusive results - an empirical study

PubMed Central

Djulbegovic, Benjamin; Kumar, Ambuj; Magazin, Anja; Schroen, Anneke T.; Soares, Heloisa; Hozo, Iztok; Clarke, Mike; Sargent, Daniel; Schell, Michael J.

2010-01-01

Objective Optimism bias refers to unwarranted belief in the efficacy of new therapies. We assessed the impact of optimism bias on a proportion of trials that did not answer their research question successfully, and explored whether poor accrual or optimism bias is responsible for inconclusive results. Study Design Systematic review Setting Retrospective analysis of a consecutive series phase III randomized controlled trials (RCTs) performed under the aegis of National Cancer Institute Cooperative groups. Results 359 trials (374 comparisons) enrolling 150,232 patients were analyzed. 70% (262/374) of the trials generated conclusive results according to the statistical criteria. Investigators made definitive statements related to the treatment preference in 73% (273/374) of studies. Investigators’ judgments and statistical inferences were concordant in 75% (279/374) of trials. Investigators consistently overestimated their expected treatment effects, but to a significantly larger extent for inconclusive trials. The median ratio of expected over observed hazard ratio or odds ratio was 1.34 (range 0.19 – 15.40) in conclusive trials compared to 1.86 (range 1.09 – 12.00) in inconclusive studies (p<0.0001). Only 17% of the trials had treatment effects that matched original researchers’ expectations. Conclusion Formal statistical inference is sufficient to answer the research question in 75% of RCTs. The answers to the other 25% depend mostly on subjective judgments, which at times are in conflict with statistical inference. Optimism bias significantly contributes to inconclusive results. PMID:21163620

Optimism bias leads to inconclusive results-an empirical study.

PubMed

Djulbegovic, Benjamin; Kumar, Ambuj; Magazin, Anja; Schroen, Anneke T; Soares, Heloisa; Hozo, Iztok; Clarke, Mike; Sargent, Daniel; Schell, Michael J

2011-06-01

Optimism bias refers to unwarranted belief in the efficacy of new therapies. We assessed the impact of optimism bias on a proportion of trials that did not answer their research question successfully and explored whether poor accrual or optimism bias is responsible for inconclusive results. Systematic review. Retrospective analysis of a consecutive-series phase III randomized controlled trials (RCTs) performed under the aegis of National Cancer Institute Cooperative groups. Three hundred fifty-nine trials (374 comparisons) enrolling 150,232 patients were analyzed. Seventy percent (262 of 374) of the trials generated conclusive results according to the statistical criteria. Investigators made definitive statements related to the treatment preference in 73% (273 of 374) of studies. Investigators' judgments and statistical inferences were concordant in 75% (279 of 374) of trials. Investigators consistently overestimated their expected treatment effects but to a significantly larger extent for inconclusive trials. The median ratio of expected and observed hazard ratio or odds ratio was 1.34 (range: 0.19-15.40) in conclusive trials compared with 1.86 (range: 1.09-12.00) in inconclusive studies (P<0.0001). Only 17% of the trials had treatment effects that matched original researchers' expectations. Formal statistical inference is sufficient to answer the research question in 75% of RCTs. The answers to the other 25% depend mostly on subjective judgments, which at times are in conflict with statistical inference. Optimism bias significantly contributes to inconclusive results. Copyright © 2011 Elsevier Inc. All rights reserved.

Effectiveness of 3 methods of anchorage reinforcement for maximum anchorage in adolescents: A 3-arm multicenter randomized clinical trial.

PubMed

Sandler, Jonathan; Murray, Alison; Thiruvenkatachari, Badri; Gutierrez, Rodrigo; Speight, Paul; O'Brien, Kevin

2014-07-01

The objective of this 3-arm parallel randomized clinical trial was to compare the effectiveness of temporary anchorage devices (TADs), Nance button palatal arches, and headgear for anchorage supplementation in the treatment of patients with malocclusions that required maximum anchorage. This trial was conducted between August 2008 and February 2013 in 2 orthodontic departments in the United Kingdom. The study included 78 patients (ages, 12-18 years; mean age, 14.2 years) who needed maximum anchorage. Eligibility criteria included no active caries, exemplary oral hygiene, and maximum anchorage required. The primary outcome was mesial molar movement during the period in which anchorage supplementation was required. The secondary outcomes were duration of anchorage reinforcement, number of treatment visits, number of casual and failed appointments, total treatment time, dento-occlusal change, and patients' perceptions of the method of anchorage supplementation. Treatment allocation was implemented by contacting via the Internet the randomization center at the University of Nottingham, Clinical Trials Unit. The randomization was based on a computer-generated pseudo-random code with random permuted blocks of randomly varying size. A research assistant who was blinded to the group allocation recorded all data. The patients were randomly allocated to receive anchorage supplementation with TADs, a Nance button on a palatal arch, or headgear. They were all treated with maxillary and mandibular preadjusted edgewise fixed appliances with 0.022-in slot prescription brackets. They were followed until orthodontic treatment was complete. Seventy-eight patients were randomized in a 1:1:1 ratio among the 3 groups. The baseline characteristics were similar in the groups, and they were treated for an average of 27.4 months (SD, 7.1 months); 71 completed orthodontic treatment. The data were analyzed on a per-protocol basis and showed no differences in the effectiveness of anchorage supplementation between TADs, Nance button palatal arches, and headgear. Compared with headgear, the average mesial movements of the maxillary right molar were 0.62 mm (-0.32 to 1.55 mm) with the Nance and -0.58 mm (-1.53 to 0.36 mm) with TADs; the maxillary left molar was moved -0.09 mm (-1.00 to 0.83 mm) with the Nance and -0.96 mm (-1.89 to -0.04 mm) with the TADs. Peer assessment rating scores were significantly better with the TADs than in the headgear and Nance groups. The patient questionnaires showed that comfort levels on placement of the TADs and the Nance were similar. Headgear was more troublesome and less popular with the patients. There was no difference in the effectiveness between the 3 groups in terms of anchorage support. There were more problems with the headgear and Nance buttons than with the TADs. The quality of treatment was better with TADs. As a result, TADS might be the preferred method for reinforcing orthodontic anchorage in patients who need maximum anchorage. ClinicalTrials.gov Identifier: NCT00995436. The protocol was published on the above site before the trial commencement. The British Orthodontic Society Foundation funded the study and American Orthodontics provided all the TADs and associated equipment. Copyright © 2014 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

Ciclosporin compared with prednisolone therapy for patients with pyoderma gangrenosum: cost-effectiveness analysis of the STOP GAP trial.

PubMed

Mason, J M; Thomas, K S; Ormerod, A D; Craig, F E; Mitchell, E; Norrie, J; Williams, H C

2017-12-01

Pyoderma gangrenosum (PG) is a painful, ulcerating skin disease with poor evidence for management. Prednisolone and ciclosporin are the most commonly used treatments, although not previously compared within a randomized controlled trial (RCT). To compare the cost-effectiveness of ciclosporin and prednisolone-initiated treatment for patients with PG. Quality of life (QoL, EuroQoL five dimensions three level questionnaire, EQ-5D-3L) and resource data were collected as part of the STOP GAP trial: a multicentre, parallel-group, observer-blind RCT. Within-trial analysis used bivariate regression of costs and quality-adjusted life years (QALYs), with multiple imputation of missing data, informing a probabilistic assessment of incremental treatment cost-effectiveness from a health service perspective. In the base case analysis, when compared with prednisolone, ciclosporin was cost-effective due to a reduction in costs [net cost: -£1160; 95% confidence interval (CI) -2991 to 672] and improvement in QoL (net QALYs: 0·055; 95% CI 0·018-0·093). However, this finding appears driven by a minority of patients with large lesions (≥ 20 cm 2 ) (net cost: -£5310; 95% CI -9729 to -891; net QALYs: 0·077; 95% CI 0·004-0·151). The incremental cost-effectiveness of ciclosporin for the majority of patients with smaller lesions was £23 374/QALY, although the estimate is imprecise: the probability of being cost-effective at a willingness-to-pay of £20 000/QALY was 43%. Consistent with the clinical findings of the STOP GAP trial, patients with small lesions should receive treatment guided by the side-effect profiles of the drugs and patient preference - neither strategy is clearly a preferred use of National Health Service resources. However, ciclosporin-initiated treatment may be more cost-effective for patients with large lesions. © 2017 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

Revisiting sample size: are big trials the answer?

PubMed

Lurati Buse, Giovanna A L; Botto, Fernando; Devereaux, P J

2012-07-18

The superiority of the evidence generated in randomized controlled trials over observational data is not only conditional to randomization. Randomized controlled trials require proper design and implementation to provide a reliable effect estimate. Adequate random sequence generation, allocation implementation, analyses based on the intention-to-treat principle, and sufficient power are crucial to the quality of a randomized controlled trial. Power, or the probability of the trial to detect a difference when a real difference between treatments exists, strongly depends on sample size. The quality of orthopaedic randomized controlled trials is frequently threatened by a limited sample size. This paper reviews basic concepts and pitfalls in sample-size estimation and focuses on the importance of large trials in the generation of valid evidence.

Virtual reality cognitive behavior therapy for public speaking anxiety: a randomized clinical trial.

PubMed

Wallach, Helene S; Safir, Marilyn P; Bar-Zvi, Margalit

2009-05-01

Public speaking anxiety (PSA) is a common phobia. Although cognitive behavior therapy (CBT) is preferred, difficulties arise with the exposure component (lack of therapist control, patient's inability to imagine, self-flooding, loss of confidentiality resulting from public exposure). Virtual reality CBT (VRCBT) enables a high degree of therapist control, thus overcoming these difficulties. This study examined whether VRCBT is an alternative to CBT. Participants with PSA were randomly assigned to VRCBT (28 participants), CBT (30 participants), and wait list control (WLC; 30 participants). VRCBT and CBT were significantly more effective than WLC in anxiety reduction on four of five anxiety measures, and on subject's self-rating of anxiety during a behavioral task. No significant differences were found on observer ratings of the behavioral task. However, twice as many participants dropped out from CBT than from VRCBT. Our results demonstrated that VRCBT is an effective and brief treatment regimen, equal to CBT.

Preference for point-light human biological motion in newborns: contribution of translational displacement.

PubMed

Bidet-Ildei, Christel; Kitromilides, Elenitsa; Orliaguet, Jean-Pierre; Pavlova, Marina; Gentaz, Edouard

2014-01-01

In human newborns, spontaneous visual preference for biological motion is reported to occur at birth, but the factors underpinning this preference are still in debate. Using a standard visual preferential looking paradigm, 4 experiments were carried out in 3-day-old human newborns to assess the influence of translational displacement on perception of human locomotion. Experiment 1 shows that human newborns prefer a point-light walker display representing human locomotion as if on a treadmill over random motion. However, no preference for biological movement is observed in Experiment 2 when both biological and random motion displays are presented with translational displacement. Experiments 3 and 4 show that newborns exhibit preference for translated biological motion (Experiment 3) and random motion (Experiment 4) displays over the same configurations moving without translation. These findings reveal that human newborns have a preference for the translational component of movement independently of the presence of biological kinematics. The outcome suggests that translation constitutes the first step in development of visual preference for biological motion. PsycINFO Database Record (c) 2014 APA, all rights reserved.

Patient-Physician Communication About Code Status Preferences: A Randomized Controlled Trial

PubMed Central

Rhondali, Wadih; Perez-Cruz, Pedro; Hui, David; Chisholm, Gary B.; Dalal, Shalini; Baile, Walter; Chittenden, Eva; Bruera, Eduardo

2013-01-01

Purpose Code status discussions are important in cancer care. The best modality for such discussions has not been established. Our objective was to determine the impact of a physician ending a code status discussion with a question (autonomy approach) versus a recommendation (beneficence approach) on patients' do-not-resuscitate (DNR) preference. Methods Patients in a supportive care clinic watched two videos showing a physician-patient discussion regarding code status. Both videos were identical except for the ending: one ended with the physician asking for the patient's code status preference and the other with the physician recommending DNR. Patients were randomly assigned to watch the videos in different sequences. The main outcome was the proportion of patients choosing DNR for the video patient. Results 78 patients completed the study. 74% chose DNR after the question video, 73% after the recommendation video. Median physician compassion score was very high and not different for both videos. 30/30 patients who had chosen DNR for themselves and 30/48 patients who had not chosen DNR for themselves chose DNR for the video patient (100% v/s 62%). Age (OR=1.1/year) and white ethnicity (OR=9.43) predicted DNR choice for the video patient. Conclusion Ending DNR discussions with a question or a recommendation did not impact DNR choice or perception of physician compassion. Therefore, both approaches are clinically appropriate. All patients who chose DNR for themselves and most patients who did not choose DNR for themselves chose DNR for the video patient. Age and race predicted DNR choice. PMID:23564395

Paramedic King Laryngeal Tube airway insertion versus endotracheal intubation in simulated pediatric respiratory arrest.

PubMed

Mitchell, Michael S; Lee White, Marjorie; King, William D; Wang, Henry E

2012-01-01

Pediatric endotracheal intubation (ETI) is difficult and can have serious adverse events when performed by paramedics in the prehospital setting. Paramedics may use the King Laryngeal Tube airway (KLT) in difficult adult airways, but only limited data describe their application in pediatric patients. To compare paramedic airway insertion speed and complications between KLT and ETI in a simulated model of pediatric respiratory arrest. This prospective, randomized trial included paramedics and senior paramedic students with limited prior KLT experience. We provided brief training on pediatric KLT insertion. Using a random allocation protocol, participants performed both ETI and KLT on a pediatric mannequin (6-month old size) in simulated respiratory arrest. The primary outcomes were 1) elapsed time to successful airway placement (seconds), and 2) proper airway positioning. We compared airway insertion performance between KLT and ETI using the Wilcoxon signed-ranks test. Subjects also indicated their preferred airway device. The 25 subjects included 19 paramedics and 6 senior paramedic students. Two subjects had prior adult KLT experience. Airway insertion time was not statistically different between the KLT (median 27 secs) and ETI (median 31 secs) (p = 0.08). Esophageal intubation occurred in 2 of 25 (8%) ETI. Airway leak occurred in 3 of 25 (12%) KLT, but ventilation remained satisfactory. Eighty-four percent of the subjects preferred the KLT over ETI. Paramedics and paramedic students demonstrated similar airway insertion performance between KLT and ETI in simulated, pediatric respiratory arrest. Most subjects preferred KLT. KLT may provide a viable alternative to ETI in prehospital pediatric airway management.

The effects of listening to preferred music on pain intensity after open heart surgery

PubMed Central

Jafari, Hedayat; Zeydi, Amir Emami; Khani, Soghra; Esmaeili, Ravanbakhsh; Soleimani, Aria

2012-01-01

Background: Pain is a common phenomenon after surgery. Cardiac surgeries are no exception and patients generally experience acute pain after these surgeries. Inadequate pain management after cardiac surgery predisposes patients to many complications. Therefore, the aim of this study was to determine the effects of listening to preferred music on pain intensity after open heart surgery. Materials and Methods: This study was a randomized clinical trial (RCT) conducted in open heart intensive care unit (ICU) of a university hospital in Sari, Iran. A total of 60 patients who were scheduled to undergo open heart surgery were randomly allocated in two groups. Patients in the intervention group (n = 30) listened to their preferred music by headphones for 30 minutes, whereas those in the control group (n = 30) did not listen to music. Using a Numerical Rating Scale (NRS), pain intensity was measured among the patients before the intervention, and immediately, 30 minutes and one hour after the intervention. Data was analyzed by Chi-square test, student's t-test and repeated measures analysis of variance (ANOVA). Findings: Mean pain intensity in the intervention group before, immediately after, 30 minutes and one hour after the intervention were 5.8, 3.1, 2.5 and 2.4, respectively. Corresponding numbers in the control group were 4.7, 4.7, 4.8 and 4.9, respectively. Repeated measures ANOVA showed music to significantly reduce pain intensity (p = 0.0001) Conclusions: Music can be effective as a non-pharmacological, inexpensive, non-invasive and side effect free method for pain management after open heart surgery. PMID:23493927

Differences between Supportive Music and Imagery and Music Listening during Outpatient Chemotherapy and Potential Moderators of Treatment Effects.

PubMed

Burns, Debra S; Meadows, Anthony N; Althouse, Sandra; Perkins, Susan M; Cripe, Larry D

2018-03-09

Supportive music and imagery and music listening interventions have been effective in decreasing distress and improving mood in cancer patients receiving chemotherapy, but it is unclear whether the two interventions differ in their treatment benefits. Furthermore, previous studies have not examined moderators to determine which subgroup(s) of patients may benefit most from each intervention. To examine the effects of supportive music and imagery compared with preferred music listening on responsiveness to music therapy, distress, anxiety and depression, and benefit finding. A secondary purpose was to explore sense of coherence and locus of control as potential moderators of intervention effectiveness. A single-session, two-group comparative effectiveness randomized trial in two cancer centers. Patients were randomized to supportive music and imagery or preferred music listening during outpatient chemotherapy treatment. Data were collected at baseline and immediately after the 45-minute session. ANCOVA models were used to determine main effects of intervention as well as pairing potential moderators with group assignment to explore differences in intervention effects by moderator. There were differential effects between the two interventions with the supportive music and imagery group scoring higher in responsiveness to music therapy and benefit finding. The music listening group scores indicated lower distress. The exploratory moderating analyses suggested Health Locus of Control-Internal and Sense of Coherence influenced intervention effectiveness. Music and imagery and preferred music listening experiences may serve different therapeutic purposes, access and activate different patient resources, and may be helpful at different stages of treatment.

Effect of communication skills training program for oncologists based on patient preferences for communication when receiving bad news: a randomized controlled trial.

PubMed

Fujimori, Maiko; Shirai, Yuki; Asai, Mariko; Kubota, Kaoru; Katsumata, Noriyuki; Uchitomi, Yosuke

2014-07-10

The aim of this study was to identify the effects of a communication skills training (CST) program for oncologists, developed based on patient preferences regarding oncologists' communication. Thirty oncologists were randomly assigned to either an intervention group (IG; 2-day CST workshop) or control group (CG). Participants were assessed on their communication performance during simulated consultation and their confidence in communicating with patients at baseline and follow-up. A total of 1,192 patients (response rate, 84.6%) who had consultations with the participating oncologists at baseline and/or follow-up were assessed regarding their distress using the Hospital Anxiety and Depression Scale, satisfaction with the consultation, and trust in their oncologist after the consultation. At the follow-up survey, the performance scores of the IG had improved significantly, in terms of their emotional support (P = .011), setting up a supportive environment (P = .002), and ability to deliver information (P = .001), compared with those of the CG. Oncologists in the IG were rated higher at follow-up than those in the CG in terms of their confidence in themselves (P = .001). Patients who met with oncologists after they had undergone the CST were significantly less depressed than those who met with oncologists in the CG (P = .027). However, the CST program did not affect patient satisfaction with oncologists' style of communication. A CST program based on patient preferences is effective for both oncologists and patients with cancer. Oncologists should consider CST as an approach to enhancing their communication skills. © 2014 by American Society of Clinical Oncology.

Antibiotic prophylaxis for term or near-term premature rupture of membranes: metaanalysis of randomized trials.

PubMed

Saccone, Gabriele; Berghella, Vincenzo

2015-05-01

The objective of the study was to evaluate the efficacy of antibiotic prophylaxis in women with term or near-term premature rupture of membranes. Searches were performed in MEDLINE, OVID, Scopus, ClinicalTrials.gov, the PROSPERO International Prospective Register of Systematic Reviews, EMBASE, ScienceDirect.com, MEDSCAPE, and the Cochrane Central Register of Controlled Trials with the use of a combination of key words and text words related to antibiotics, premature rupture of membranes, term, and trials from inception of each database to September 2014. We included all randomized trials of singleton gestations with premature rupture of membranes at 36 weeks or more, who were randomized to antibiotic prophylaxis or control (either placebo or no treatment). The primary outcomes included maternal chorioamnionitis and neonatal sepsis. A subgroup analysis on studies with latency more than 12 hours was planned. Before data extraction, the review was registered with the PROSPERO International Prospective Register of Systematic Reviews (registration number CRD42014013928). The metaanalysis was performed following the Preferred Reporting Item for Systematic Reviews and Meta-analyses statement. Women who received antibiotics had the same rate of chorioamnionitis (2.7% vs 3.7%; relative risk [RR], 0.73, 95% confidence interval [CI], 0.48-1.12), endometritis (0.4% vs 0.9%; RR, 0.44, 95% CI, 0.18-1.10), maternal infection (3.1% vs 4.6%; RR, 0.48, 95% CI, 0.19-1.21), and neonatal sepsis (1.0% vs 1.4%; RR, 0.69, 95% CI, 0.34-1.39). In the planned subgroup analysis, women with latency longer than 12 hours, who received antibiotics, had a lower rate of chorioamnionitis (2.9% vs 6.1%; RR, 0.49, 95% CI, 0.27-0.91) and endometritis (0% vs 2.2%; RR, 0.12, 95% CI, 0.02-0.62) compared with the control group. Antibiotic prophylaxis for term or near-term premature rupture of membranes is not associated with any benefits in either maternal or neonatal outcomes. In women with latency longer than 12 hours, prophylactic antibiotics are associated with significantly lower rates of chorioamnionitis by 51% and endometritis by 88%. Copyright © 2015 Elsevier Inc. All rights reserved.

Physical and Psychologic Effects of Aromatherapy Inhalation on Pregnant Women: A Randomized Controlled Trial

PubMed Central

2013-01-01

Abstract Objectives Stress reduction care is important for pregnant women to decrease obstetric complications and children's health problems after birth. The aim of this study is to clarify the physical and psychologic effects of inhalation aromatherapy on pregnant women. Essential oils with high linalool and linalyl acetate content that may be used during pregnancy were selected and among these, and the one preferred by the participant was used. Design This was a prospective, randomized, controlled trial. Settings/location This trial was performed at a gynecology outpatient department in a hospital in Kyoto, Japan. Participants The study included pregnant women in week 28 of a single pregnancy with a normal course. Interventions Participants were randomly assigned into an aromatherapy group and a control group. They were seated in the resting, seated position for 10 minutes. During the latter 5 minutes of each 10-minute session, aromatherapy inhalation was performed for the aromatherapy group. Outcome measures Before and after the intervention, the Profile of Mood States (POMS) was measured. During the trial, the heart-rate fluctuations were measured for the autonomic nervous system regulation. Results A total of 13 pregnant women participated in the trial. Seven (7) participants were assigned to the aromatherapy group and 6 participants to the control group. The results of the POMS were such that based on an intragroup comparison, significant differences were observed in the Tension-Anxiety score (p<0.05) and the Anger-Hostility score (p<0.05), and the respective improvements observed were due to aromatherapy. The results of the autonomic nervous system regulation were such that based on an intragroup comparison within the aromatherapy group, the parasympathetic nerve activity increased significantly (p<0.05). Conclusions Aromatherapy inhalation using essential oils containing linalyl acetate and linalool was found to be effective for the POMS and parasympathetic nerve activity, based on an intragroup comparison. However, based on a comparison between the groups, no substantial difference was observed; hence, further study is necessary in the future. PMID:23410527

Preferences for a third-trimester ultrasound scan in a low-risk obstetric population: a discrete choice experiment.

PubMed

Lynn, Fiona A; Crealey, Grainne E; Alderdice, Fiona A; McElnay, James C

2015-10-01

Establish maternal preferences for a third-trimester ultrasound scan in a healthy, low-risk pregnant population. Cross-sectional study incorporating a discrete choice experiment. A large, urban maternity hospital in Northern Ireland. One hundred and forty-six women in their second trimester of pregnancy. A discrete choice experiment was designed to elicit preferences for four attributes of a third-trimester ultrasound scan: health-care professional conducting the scan, detection rate for abnormal foetal growth, provision of non-medical information, cost. Additional data collected included age, marital status, socio-economic status, obstetric history, pregnancy-specific stress levels, perceived health and whether pregnancy was planned. Analysis was undertaken using a mixed logit model with interaction effects. Women's preferences for, and trade-offs between, the attributes of a hypothetical scan and indirect willingness-to-pay estimates. Women had significant positive preference for higher rate of detection, lower cost and provision of non-medical information, with no significant value placed on scan operator. Interaction effects revealed subgroups that valued the scan most: women experiencing their first pregnancy, women reporting higher levels of stress, an adverse obstetric history and older women. Women were able to trade on aspects of care and place relative importance on clinical, non-clinical outcomes and processes of service delivery, thus highlighting the potential of using health utilities in the development of services from a clinical, economic and social perspective. Specifically, maternal preferences exhibited provide valuable information for designing a randomized trial of effectiveness and insight for clinical and policy decision makers to inform woman-centred care. © 2013 Blackwell Publishing Ltd.

[120 mmHg for everyone?].

PubMed

Wiersma, Tjerk

2016-01-01

The recently published Systolic Blood Pressure Intervention Trial (SPRINT) casts new light on the issue of lowering blood pressure to 120 mmHg. The trial randomized 9161 patients with systolic blood pressures of 130 mmHg - 180 mmHg and increased cardiovascular risk into a group receiving intensive treatment (target 120 mmHg) and a group given standard treatment (target 140 mmHg). The trial was stopped earlier than foreseen because interim analysis showed a lower incidence rate of myocardial infarction, stroke, heart failure and death from cardiovascular causes in the group given intensive treatment (1.65 versus 2.19 per year, hazard ratio 0.75; 95% CI 0.64-0.89; p < 0.001). These results open up the possibility of aiming for lower blood pressure targets in antihypertensive treatment. It is questionable whether this strategy would be preferred by every patient. New guidelines on cardiovascular risk management should pay more attention to shared decision-making where doctors inform patients about the benefits and risks of strict or less strict blood pressure control and patients choose personal targets.

Proximal femoral fractures: Principles of management and review of literature.

PubMed

Mittal, Ravi; Banerjee, Sumit

2012-06-01

The purpose of this study was to review the principles involved in the management of proximal femoral fractures as reported in the literature. A medical literature search in the MEDLINE (PubMed) and Cochrane database was undertaken to review strategies and principles in proximal femoral fracture treatment. Randomized control trials and meta analysis were given preference while case reports/small series were rejected. Early anatomical reduction and surgical fixation remains the best option to reduce the risk of complications like non-union and avascular necrosis in treating fracture neck femurs. Cancellous screws continue to be the preferred treatment for fixation of neck femur fractures in younger population until the benefit of using sliding hip screws is validated by large multicentric studies. In the geriatric age group, early prosthetic replacement brings down the mortality and morbidity associated with neck femur fractures. Sliding hip screw (DHS) is the best available option for stable inter trochanteric fractures. The use of intramedullary nails e.g. PFN is beneficial in treating inter trochanteric fractures with comminution and loss of lateral buttress. Intramedullary implants have been proven to have increased success rates in subtrochanteric fractures and should be preferred over extramedullary plate fixation systems.

Proximal femoral fractures: Principles of management and review of literature

PubMed Central

Mittal, Ravi; Banerjee, Sumit

2012-01-01

Purpose The purpose of this study was to review the principles involved in the management of proximal femoral fractures as reported in the literature. Methods: A medical literature search in the MEDLINE (PubMed) and Cochrane database was undertaken to review strategies and principles in proximal femoral fracture treatment. Randomized control trials and meta analysis were given preference while case reports/small series were rejected. Results and conclusions: Early anatomical reduction and surgical fixation remains the best option to reduce the risk of complications like non-union and avascular necrosis in treating fracture neck femurs. Cancellous screws continue to be the preferred treatment for fixation of neck femur fractures in younger population until the benefit of using sliding hip screws is validated by large multicentric studies. In the geriatric age group, early prosthetic replacement brings down the mortality and morbidity associated with neck femur fractures. Sliding hip screw (DHS) is the best available option for stable inter trochanteric fractures. The use of intramedullary nails e.g. PFN is beneficial in treating inter trochanteric fractures with comminution and loss of lateral buttress. Intramedullary implants have been proven to have increased success rates in subtrochanteric fractures and should be preferred over extramedullary plate fixation systems. PMID:25983451

Future Time Perspective in Occupational Teams: Do Older Workers Prefer More Familiar Teams?

PubMed Central

Gärtner, Laura U. A.; Hertel, Guido

2017-01-01

Working in teams is quite popular across different industries and cultures. While some of these teams exist for longer time periods, other teams collaborate only for short periods and members switch into new teams after goals are accomplished. However, workers’ preferences for joining a new team might vary in different ways. Based on Carstensen’s socioemotional selectivity theory, we predict that emotionally meaningful teams are prioritized when occupational future time perspective (OFTP) is perceived as limited. Building and expanding on studies outside of the work context, we expected that older as compared to younger workers prefer more familiar teams, and that this effect is mediated by workers’ OFTP. Moreover, we assumed that experimentally manipulated OFTP can change such team preferences. The hypotheses were tested in an online scenario study using three experimental conditions (within-person design). Four hundred and fifty-four workers (57% female, age M = 45.98, SD = 11.46) were asked to choose between a familiar and a new team in three consecutive trials: under an unspecified OFTP (baseline), under an expanded OFTP (amendment of retirement age), and under a restricted OFTP (insolvency of the current company). Whereas the baseline condition was always first, the order of the second and third conditions was randomized among participants. In the baseline condition, results showed the expected mediation effect of workers’ OFTP on the relation between workers’ age and preference for a familiar over a new team. Higher age was associated with more limited OFTP, which in turn was associated with higher preference for a familiar over a new team. Moreover, experimentally restricting OFTP increased preference for a familiar team over a new team regardless of workers’ age, providing further evidence for the assumed causal processes and showing interesting avenues for practical interventions in occupational teams. PMID:29018376

Future Time Perspective in Occupational Teams: Do Older Workers Prefer More Familiar Teams?

PubMed

Gärtner, Laura U A; Hertel, Guido

2017-01-01

Working in teams is quite popular across different industries and cultures. While some of these teams exist for longer time periods, other teams collaborate only for short periods and members switch into new teams after goals are accomplished. However, workers' preferences for joining a new team might vary in different ways. Based on Carstensen's socioemotional selectivity theory, we predict that emotionally meaningful teams are prioritized when occupational future time perspective (OFTP) is perceived as limited. Building and expanding on studies outside of the work context, we expected that older as compared to younger workers prefer more familiar teams, and that this effect is mediated by workers' OFTP. Moreover, we assumed that experimentally manipulated OFTP can change such team preferences. The hypotheses were tested in an online scenario study using three experimental conditions (within-person design). Four hundred and fifty-four workers (57% female, age M = 45.98, SD = 11.46) were asked to choose between a familiar and a new team in three consecutive trials: under an unspecified OFTP (baseline), under an expanded OFTP (amendment of retirement age), and under a restricted OFTP (insolvency of the current company). Whereas the baseline condition was always first, the order of the second and third conditions was randomized among participants. In the baseline condition, results showed the expected mediation effect of workers' OFTP on the relation between workers' age and preference for a familiar over a new team. Higher age was associated with more limited OFTP, which in turn was associated with higher preference for a familiar over a new team. Moreover, experimentally restricting OFTP increased preference for a familiar team over a new team regardless of workers' age, providing further evidence for the assumed causal processes and showing interesting avenues for practical interventions in occupational teams.

Shared Decision-Making with Parents of Acutely Ill Children: A Narrative Review.

PubMed

Aronson, Paul L; Shapiro, Eugene D; Niccolai, Linda M; Fraenkel, Liana

Shared decision-making (SDM) has mostly been used with adults and parents in the primary care setting, and there is limited knowledge on the use of SDM with parents of acutely ill children. The objective of this study was to review the literature on SDM with parents in the management of acutely ill children. We searched MEDLINE, SCOPUS, PsycINFO, the Cochrane Library, and ClinicalTrials.gov for English language studies published from the time of database inception to February, 2017. Study eligibility criterion was use of SDM with parents for children aged 18 years or younger with an acute medical problem. We identified 2 ongoing clinical trials and 10 published studies that met inclusion criteria: 2 using hypothetical SDM scenarios, 1 mixed methods study, and 7 intervention studies. Only 1 study compared an SDM intervention with usual care in a randomized controlled trial. The limited literature shows that parents of acutely ill children have differing preferences for testing and/or treatment, and that they generally want the opportunity to express those preferences through an SDM process. Use of SDM often results in acutely ill children undergoing fewer and/or less intensive testing or treatment, although the effect on outcomes is unclear. Parents welcome participation in SDM for management decisions with their acutely ill child. Further investigation is needed to determine how best to implement SDM with parents of acutely ill children and to assess the effect of SDM on outcomes. Copyright © 2017 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

Differences in Military Obstacle Course Performance Between Three Energy-Storing and Shock-Adapting Prosthetic Feet in High-Functioning Transtibial Amputees: A Double-Blind, Randomized Control Trial.

PubMed

Highsmith, M Jason; Kahle, Jason T; Miro, Rebecca M; Lura, Derek J; Carey, Stephanie L; Wernke, Matthew M; Kim, Seok Hun; Quillen, William S

2016-11-01

Approximately 683 persons engaged in military service experienced transtibial amputation (TTA) related to recent war in Iraq and Afghanistan. Military TTAs function at a level beyond basic ambulation. No empirical data demonstrate which higher functioning prosthetic feet maximize injured service personnel's ability to continue performing at a level commensurate with return to duty. This study's purpose was to determine which of three high-functioning, energy-storing prosthetic feet maximize performance and preference in a field obstacle course (OC) and to quantify physical performance differences between TTAs and high-functioning nonamputees. A randomized, double-blind, repeated measures experimental design compared three prosthetic feet (Ossur Variflex, Endolite Elite Blade, and Ossur Re-Flex Rotate) during performance on a field OC. TTAs accommodated with study feet and the OC before assessment. 14 TTAs and 14 nonamputee controls completed the course. Subjective and objective performance differences were compared across feet conditions and between groups. Total OC completion times were similar between prosthetic feet: Elite-Blade (419 seconds ± 130), Variflex (425 seconds ± 144), and Re-Flex Rotate (444 seconds ± 220). Controls' OC completion time (287.2 seconds ± 58) was less (p ≤ 0.05) than TTA times. In total, controls had faster completion times (p ≤ 0.05) compared to all prosthetic feet conditions in 13/17 obstacles. Re-Flex Rotate had 2 additional obstacles different (p ≤ 0.05) than controls and required more time to complete. Median RPE values were lower (p ≤ 0.05) for controls than TTA regardless of foot. Regarding foot preference for OC completion, 7/14 (50%) preferred Elite Blade, 5/14 (36%) preferred Re-Flex Rotate, and the remaining 2/14 (14%) preferred Variflex. Controls completed the OC faster and with less effort than TTAs regardless of prosthetic foot. No clear differences in prosthetic feet emerged during OC completion; however, individual task performance, perceived effort, and preference resulted in trends of slight performance improvement with and preference for Elite Blade, a dual function energy-storing and return foot combined with vertical shock absorption. Understanding how to maximally improve performance in such functional tasks may allow service members to best sustain physical fitness, return to their military occupational specialty and possibly in-theater duty. Reprint & Copyright © 2016 Association of Military Surgeons of the U.S.

Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations.

PubMed

NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

2017-08-01

Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.

The Effect of Message Content and Clinical Outcome on Patients' Perception of Physician Compassion: A Randomized Controlled Trial.

PubMed

Tanco, Kimberson; Azhar, Ahsan; Rhondali, Wadih; Rodriguez-Nunez, Alfredo; Liu, Diane; Wu, Jimin; Baile, Walter; Bruera, Eduardo

2018-03-01

In a previous randomized crossover study, patients perceived a physician delivering a more optimistic message (MO) as more compassionate and professional. However, the impact of the clinical outcome of the patient on patient's perception of physician's level of compassion and professionalism has not been previously studied. Our aim was to determine if the reported clinical outcome modified the patient's perception of physician compassion, professionalism, impression, and preference for physician. One hundred twenty-eight advanced cancer patients in an outpatient Supportive Care Center were randomized to complete validated questionnaires about patients' perception of physician's level of compassion, professionalism, impression, and preference of physician for themselves and their family after watching scripted videos depicting a physician delivering an MO versus a less optimistic (LO) message followed by a clinical vignette depicting a worse outcome. Median age was 61 years and 55% were female. There was no difference in compassion score after the vignette in the MO and LO groups. However, there were significantly worse overall impression and professionalism scores in both the MO and LO groups after the vignette. In the MO group, preference for the physician for themselves and their family significantly decreased after the vignette. Seeing a worse clinical outcome did not change the patients' appraisal of an inappropriately optimistic physician. However, it reduced the overall impression of both physicians that conveyed an MO or an LO message and it also resulted in less likelihood of choosing the MO physician for themselves and their family. The study found that a patient's perception of a physician's compassion did not change after reading a vignette describing a negative clinical outcome, regardless of whether the physician had given a more or a less optimistic message to the patient. However, the results suggested that patients perceived worse professionalism and overall physician impression scores for both more and less optimistic physicians and lower likelihood to choose the more optimistic physician for themselves and their family. © AlphaMed Press 2017.

Disease-modifying antirheumatic drugs other than methotrexate in rheumatoid arthritis and seronegative arthritis.

PubMed

Nandi, Pradip; Kingsley, Gabrielle H; Scott, David L

2008-05-01

To outline recent research findings with nonmethotrexate disease-modifying antirheumatic drugs in rheumatoid arthritis and seronegative arthritis spanning systematic reviews, randomized controlled trials, observational clinical practice trials and assessments of adverse effects. Systematic reviews show no important differences between methotrexate, leflunomide and sulfasalazine monotherapies; early disease-modifying antirheumatic drug therapy reduces erosive progression. Observational studies show that nonmethotrexate disease-modifying antirheumatic drugs are widely prescribed; their usage has increased in the biologic era. A systemic review also showed patients who failed monotherapy benefited from disease-modifying antirheumatic drug combinations without excess toxicity. Randomized controlled trials of intensive initial disease-modifying antirheumatic drug combinations showed they reduce synovitis and erosive damage, especially when used with steroids. The subsequent sequence of disease-modifying antirheumatic drugs and the value of changing disease-modifying antirheumatic drug monotherapies or stepping-up to combination disease-modifying antirheumatic drugs are, however, unresolved. The adverse risks of nonmethotrexate disease-modifying antirheumatic drugs have been evaluated, including infections and lung disease; patient-related risks seem more important than drug-related risks, though several disease-modifying antirheumatic drugs increase both types of adverse reactions. Two limitations of nonmethotrexate disease-modifying antirheumatic drugs are reduced impact on comorbidities like cardiovascular disease and reduced patient and clinician preferences for these treatments. Nonmethotrexate disease-modifying antirheumatic drugs are effective, relatively well tolerated and widely used. Their role in intensive treatment strategies in early rheumatoid arthritis appears of crucial importance.

Cattle and sheep develop preference for drinking water containing grape seed tannin.

PubMed

Kronberg, S L; Schauer, C S

2013-10-01

Ingestion of small amounts of some types of condensed tannins (CTs) by ruminant livestock can provide nutritional, environmental and economic benefits. However, practical methods are needed to make these tannins more available to ruminant livestock. Results from previous trials with crude quebracho and black wattle tannin indicated that cattle and/or sheep would not preferentially drink water containing these tannins. Therefore, we conducted preference trials to determine if cattle and sheep would learn to prefer water containing purified grape seed tannin (GST) that provided up to 2% of their daily dry matter (DM) intake. After gradual exposure to increasing amounts of this tannin in water during a pre-trial period, five adult ewes and five yearling heifers fed lucerne (Medicago sativa) pellets (19% CP) were offered water and several concentrations of GST solutions for either 15 (sheep trial) or 20 days (cattle trial). We measured intake of all liquids daily. Concentrations of blood urea were also measured for heifers when they drank only tannin solutions or water. Both sheep and cattle developed preferences for water with GST in it over water alone (P < 0.01) although this preference appeared earlier in the trial for sheep than for cattle. For the sheep, mean daily intake of water alone and all tannin solutions (in total) was 0.6 and 6.1 l, respectively. For the cattle, mean daily intake of water and all tannin solutions in total was 21.8 and 20.6 l, respectively, in the first half of the trial and 10.8 and 26.1 l, respectively, in the second half of the trial. Compared with the other tannin solutions, both sheep and cattle drank more of the solution with the highest tannin concentration (2% of daily DM intake as GST) than of water on more trial days (P < 0.05). Ingestion of water with the highest concentration of GST reduced blood plasma urea concentration in the cattle by 9% to 14% (P ≤ 0.10) compared with ingestion of water alone. Results from the trials suggest that providing grape seed and perhaps other CTs via drinking water may be a practical way to introduce CTs into sheep and cattle diets.

An economic evaluation of a video- and text-based computer-tailored intervention for smoking cessation: a cost-effectiveness and cost-utility analysis of a randomized controlled trial.

PubMed

Stanczyk, Nicola E; Smit, Eline S; Schulz, Daniela N; de Vries, Hein; Bolman, Catherine; Muris, Jean W M; Evers, Silvia M A A

2014-01-01

Although evidence exists for the effectiveness of web-based smoking cessation interventions, information about the cost-effectiveness of these interventions is limited. The study investigated the cost-effectiveness and cost-utility of two web-based computer-tailored (CT) smoking cessation interventions (video- vs. text-based CT) compared to a control condition that received general text-based advice. In a randomized controlled trial, respondents were allocated to the video-based condition (N = 670), the text-based condition (N = 708) or the control condition (N = 721). Societal costs, smoking status, and quality-adjusted life years (QALYs; EQ-5D-3L) were assessed at baseline, six-and twelve-month follow-up. The incremental costs per abstinent respondent and per QALYs gained were calculated. To account for uncertainty, bootstrapping techniques and sensitivity analyses were carried out. No significant differences were found in the three conditions regarding demographics, baseline values of outcomes and societal costs over the three months prior to baseline. Analyses using prolonged abstinence as outcome measure indicated that from a willingness to pay of €1,500, the video-based intervention was likely to be the most cost-effective treatment, whereas from a willingness to pay of €50,400, the text-based intervention was likely to be the most cost-effective. With regard to cost-utilities, when quality of life was used as outcome measure, the control condition had the highest probability of being the most preferable treatment. Sensitivity analyses yielded comparable results. The video-based CT smoking cessation intervention was the most cost-effective treatment for smoking abstinence after twelve months, varying the willingness to pay per abstinent respondent from €0 up to €80,000. With regard to cost-utility, the control condition seemed to be the most preferable treatment. Probably, more time will be required to assess changes in quality of life. Future studies with longer follow-up periods are needed to investigate whether cost-utility results regarding quality of life may change in the long run. Nederlands Trial Register NTR3102.

Single-visit or multiple-visit root canal treatment: systematic review, meta-analysis and trial sequential analysis.

PubMed

Schwendicke, Falk; Göstemeyer, Gerd

2017-02-01

Single-visit root canal treatment has some advantages over conventional multivisit treatment, but might increase the risk of complications. We systematically evaluated the risk of complications after single-visit or multiple-visit root canal treatment using meta-analysis and trial-sequential analysis. Controlled trials comparing single-visit versus multiple-visit root canal treatment of permanent teeth were included. Trials needed to assess the risk of long-term complications (pain, infection, new/persisting/increasing periapical lesions ≥1 year after treatment), short-term pain or flare-up (acute exacerbation of initiation or continuation of root canal treatment). Electronic databases (PubMed, EMBASE, Cochrane Central) were screened, random-effects meta-analyses performed and trial-sequential analysis used to control for risk of random errors. Evidence was graded according to GRADE. 29 trials (4341 patients) were included, all but 6 showing high risk of bias. Based on 10 trials (1257 teeth), risk of complications was not significantly different in single-visit versus multiple-visit treatment (risk ratio (RR) 1.00 (95% CI 0.75 to 1.35); weak evidence). Based on 20 studies (3008 teeth), risk of pain did not significantly differ between treatments (RR 0.99 (95% CI 0.76 to 1.30); moderate evidence). Risk of flare-up was recorded by 8 studies (1110 teeth) and was significantly higher after single-visit versus multiple-visit treatment (RR 2.13 (95% CI 1.16 to 3.89); very weak evidence). Trial-sequential analysis revealed that firm evidence for benefit, harm or futility was not reached for any of the outcomes. There is insufficient evidence to rule out whether important differences between both strategies exist. Dentists can provide root canal treatment in 1 or multiple visits. Given the possibly increased risk of flare-ups, multiple-visit treatment might be preferred for certain teeth (eg, those with periapical lesions). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Cold therapy for the management of pain associated with deep breathing and coughing post-cardiac surgery.

PubMed

Chailler, Myrianne; Ellis, Jacqueline; Stolarik, Anne; Woodend, Kirsten

2010-01-01

Coughing has been identified as the most painful experience post cardiac surgery. Participants (n = 32), in a randomized crossover trial, applied a frozen gel pack to their sternal incision dressing before performing deep breathing and coughing (DB & C) exercises. Pain scores from 0 to 10 at rest were compared with pain scores post DB & C with and without the gel pack. Participants were also asked to describe their sensations with the frozen gel pack, as well as their preferences for gel pack application. The repeated measures analysis of variance revealed a significant reduction in pain scores between pre- and post-application of the gel pack (F = 28.69, p < .001). There were 22 (69%) participants who preferred the application of the gel pack compared with no gel pack. All 32 (100%) participants would reapply the gel pack in the future. This study demonstrates that cold therapy can be used to manage sternal incisional pain when DB & C.

Do Participants’ Preferences for Mode of Delivery (Text, Video, or Both) Influence the Effectiveness of a Web-Based Physical Activity Intervention?

PubMed Central

Duncan, Mitch J; Plotnikoff, Ronald C; Mummery, W Kerry

2012-01-01

Background In randomized controlled trials, participants cannot choose their preferred intervention delivery mode and thus might refuse to participate or not engage fully if assigned to a nonpreferred group. This might underestimate the true effectiveness of behavior-change interventions. Objective To examine whether receiving interventions either matched or mismatched with participants’ preferred delivery mode would influence effectiveness of a Web-based physical activity intervention. Methods Adults (n = 863), recruited via email, were randomly assigned to one of three intervention delivery modes (text based, video based, or combined) and received fully automated, Internet-delivered personal advice about physical activity. Personalized intervention content, based on the theory of planned behavior and stages of change concept, was identical across groups. Online, self-assessed questionnaires measuring physical activity were completed at baseline, 1 week, and 1 month. Physical activity advice acceptability and website usability were assessed at 1 week. Before randomization, participants were asked which delivery mode they preferred, to categorize them as matched or mismatched. Time spent on the website was measured throughout the intervention. We applied intention-to-treat, repeated-measures analyses of covariance to assess group differences. Results Attrition was high (575/863, 66.6%), though equal between groups (t 86 3 =1.31, P =.19). At 1-month follow-up, 93 participants were categorized as matched and 195 as mismatched. They preferred text mode (493/803, 61.4%) over combined (216/803, 26.9%) and video modes (94/803, 11.7%). After the intervention, 20% (26/132) of matched-group participants and 34% (96/282) in the mismatched group changed their delivery mode preference. Time effects were significant for all physical activity outcomes (total physical activity: F 2,801 = 5.07, P = .009; number of activity sessions: F 2,801 = 7.52, P < .001; walking: F 2,801 = 8.32, P < .001; moderate physical activity: F 2,801 = 9.53, P < .001; and vigorous physical activity: F 2,801 = 6.04, P = .002), indicating that physical activity increased over time for both matched and mismatched groups. Matched-group participants improved physical activity outcomes slightly more than those in the mismatched group, but interaction effects were not significant. Physical activity advice acceptability (content scale: t 368 = .10, P = .92; layout scale: t 368 = 1.53, P = .12) and website usability (layout scale: t 426 = .05, P = .96; ease of use scale: t 426 = .21, P = .83) were generally high and did not differ between the matched and mismatched groups. The only significant difference (t 621 = 2.16, P = .03) was in relation to total time spent on the website: the mismatched group spent significantly more time on the website (14.4 minutes) than the matched group (12.1 minutes). Conclusion Participants’ preference regarding delivery mode may not significantly influence intervention outcomes. Consequently, allowing participants to choose their preferred delivery mode may not increase effectiveness of Web-based interventions. PMID:22377834

Do participants' preferences for mode of delivery (text, video, or both) influence the effectiveness of a Web-based physical activity intervention?

PubMed

Vandelanotte, Corneel; Duncan, Mitch J; Plotnikoff, Ronald C; Mummery, W Kerry

2012-02-29

In randomized controlled trials, participants cannot choose their preferred intervention delivery mode and thus might refuse to participate or not engage fully if assigned to a nonpreferred group. This might underestimate the true effectiveness of behavior-change interventions. To examine whether receiving interventions either matched or mismatched with participants' preferred delivery mode would influence effectiveness of a Web-based physical activity intervention. Adults (n = 863), recruited via email, were randomly assigned to one of three intervention delivery modes (text based, video based, or combined) and received fully automated, Internet-delivered personal advice about physical activity. Personalized intervention content, based on the theory of planned behavior and stages of change concept, was identical across groups. Online, self-assessed questionnaires measuring physical activity were completed at baseline, 1 week, and 1 month. Physical activity advice acceptability and website usability were assessed at 1 week. Before randomization, participants were asked which delivery mode they preferred, to categorize them as matched or mismatched. Time spent on the website was measured throughout the intervention. We applied intention-to-treat, repeated-measures analyses of covariance to assess group differences. Attrition was high (575/863, 66.6%), though equal between groups (t(86) (3) =1.31, P =.19). At 1-month follow-up, 93 participants were categorized as matched and 195 as mismatched. They preferred text mode (493/803, 61.4%) over combined (216/803, 26.9%) and video modes (94/803, 11.7%). After the intervention, 20% (26/132) of matched-group participants and 34% (96/282) in the mismatched group changed their delivery mode preference. Time effects were significant for all physical activity outcomes (total physical activity: F(2,801) = 5.07, P = .009; number of activity sessions: F(2,801) = 7.52, P < .001; walking: F(2,801) = 8.32, P < .001; moderate physical activity: F(2,801) = 9.53, P < .001; and vigorous physical activity: F(2,801) = 6.04, P = .002), indicating that physical activity increased over time for both matched and mismatched groups. Matched-group participants improved physical activity outcomes slightly more than those in the mismatched group, but interaction effects were not significant. Physical activity advice acceptability (content scale: t(368) = .10, P = .92; layout scale: t(368) = 1.53, P = .12) and website usability (layout scale: t(426) = .05, P = .96; ease of use scale: t(426) = .21, P = .83) were generally high and did not differ between the matched and mismatched groups. The only significant difference (t(621) = 2.16, P = .03) was in relation to total time spent on the website: the mismatched group spent significantly more time on the website (14.4 minutes) than the matched group (12.1 minutes). Participants' preference regarding delivery mode may not significantly influence intervention outcomes. Consequently, allowing participants to choose their preferred delivery mode may not increase effectiveness of Web-based interventions.

In-depth interviews of patients with primary immunodeficiency who have experienced pump and rapid push subcutaneous infusions of immunoglobulins reveal new insights on their preference and expectations.

PubMed

Cozon, Grégoire Jacques Noël; Clerson, Pierre; Dokhan, Annaïk; Fardini, Yann; Sala, Taylor Pindi; Crave, Jean-Charles

2018-01-01

Patients with primary immunodeficiency (PID) often receive immunoglobulin replacement therapy (IgRT). Physicians and patients have the choice between various methods of administration. For subcutaneous immunoglobulin infusions, patients may use an automated pump (P) or push the plunger of a syringe (rapid push [RP]). P infusions are performed once a week and last around 1 hour. RP decreases the duration of administration, but requires more frequent infusions. Eight out of 30 patients (coming from a single center) who had participated in the cross-over, randomized, open-label trial comparing P and RP participated in a focus group or underwent in-depth interviews. Patients had a long history of home-based subcutaneous immunoglobulin using P. The trial suggested that RP had slightly greater interference on daily life than P, but similar efficacy and better cost-effectiveness. When asked about the delivery method they had preferred, around one-third of patients pointed out RP rather than P. In-depth interviews may reveal unforeseen reasons for patients' preferences. Interviews underlined the complexity of the relationship that the patients maintain with their disease and IgRT. Even if they recognized the genetic nature of the disease and claimed PID was a part of them, patients tried not to be overwhelmed by the disease. IgRT by P was well integrated in patients' routine. By contrast, RP too frequently reminded the patients of their disease. In addition, some patients pointed out the difficulty of pushing the plunger due to the viscosity of the product. Coming back too frequently, RP was not perceived as time saving over a week. Long-lasting use of P could partly explain patients' reasonable reluctance to change to RP. In-depth interviews of PID patients highlighted unforeseen reasons for patients' preference that the physician needs to explore during the shared medical decision-making process.

Patient preference and satisfaction with implant-supported mandibular overdentures retained with ball or locator attachments: a crossover clinical trial.

PubMed

Krennmair, Gerald; Seemann, Rudolf; Fazekas, Andres; Ewers, Rolf; Piehslinger, Eva

2012-01-01

To determine patient satisfaction and preference for implant-supported mandibular overdentures (IOD) retained with ball or Locator attachments. In addition, peri-implant conditions and prosthodontic maintenance efforts for the final attachments were evaluated after 1 year of function. In this crossover clinical trial, 20 edentulous patients were recruited to receive two mandibular implants in the canine region and were provided with implant-retained mandibular overdentures and new complete maxillary dentures. Implant-retained mandibular overdentures were stabilized with either ball attachments or Locator attachments, in random order. After 3 months of function, the attachments in the existing denture were changed. Questionnaires on satisfaction/complaints with the prostheses were administered at baseline (with the old dentures) and after 3 months of function with each attachment, thus providing for an intraindividual comparison. The decision for the final attachment chosen was based on the patient's preference. For the definitive attachment, peri-implant conditions (peri-implant marginal bone resorption, pocket depth, and Plaque Index, Gingival Index, and Bleeding Index) as well as prosthodontic maintenance efforts and satisfaction score were evaluated after an insertion period of 1 year. Nineteen (95%) patients completed the study (1 dropout). Patient satisfaction improved significantly (P<.05) from baseline (old dentures) to the new prostheses retained with each of the two attachment types for all domains of satisfaction. However, there were no differences between ball or Locator attachment for any items of satisfaction evaluated and neither attachment had a significant patient preference. No differences for peri-implant parameters or for patient satisfaction were noted between the definitive attachments (ball, n=10; Locator, n=9) after 1 year. Although the overall incidence rate of prosthodontic maintenance did not significantly differ between both retention modalities, the Locator attachment required more postinsertion aftercare (activation of retention) than the ball anchors.

The Role of Preference on Outcomes of People Receiving Evidence-Informed Community Wound Care in Their Home or in a Nurse-Clinic Setting: A Cohort Study (n = 230).

PubMed

Harrison, Margaret B; VanDenKerkhof, Elizabeth G; Hopman, Wilma M; Carley, Meg E

2014-09-19

This study followed a cohort of community-dwelling individuals receiving wound-care in a large urban-rural region. During a randomized control trial (RCT) evaluating outcomes of receiving care in a nurse-clinic or at home, many approached were willing to participate if they could choose their location of care. This provided a unique opportunity to enroll them as a "choice" cohort, following them in the same manner as the trial participants but allowing them to select their setting of care. The objective was to investigate the role of preference and location of care on care outcomes, including satisfaction with care, healing, health-related quality of life (HRQL), pain, and resource use. This is a secondary analysis of a prospective cohort of 126 individuals enrolled in an RCT to receive care at home or in a nurse-clinic (Allocated group), and an additional 104 who received care at home or in a nurse-clinic based on their preference (Choice group). Mobile individuals with a leg ulcer of venous or mixed venous etiology, referred for community leg ulcer care, were eligible. Specially-trained nurses provided care to both groups using an evidence-informed protocol. Baseline data included socio-demographic, circumstance-of-living and a detailed wound assessment. Mean age of the cohort was 68 years. Satisfaction, healing, recurrence, pain, HRQL, and resource utilization did not differ between groups. If available, individuals should have an option of care venue given almost half of those approached indicated a clear preference for clinic or home. With outcomes being similar, health care planners and decision-makers, as well as individuals and their families, can feel confident that the setting of care will not impact the outcomes. However, larger studies in other contexts are needed to explore the interaction between choice and setting.

Design and analysis issues for economic analysis alongside clinical trials.

PubMed

Marshall, Deborah A; Hux, Margaret

2009-07-01

Clinical trials can offer a valuable and efficient opportunity to collect the health resource use and outcomes data for economic evaluation. However, economic and clinical studies differ fundamentally in the question they seek to answer. The design and analysis of trial-based cost-effectiveness studies require special consideration, which are reviewed in this article. Traditional randomized controlled trials, using an experimental design with a controlled protocol, are designed to measure safety and efficacy for product registration. Cost-effectiveness analysis seeks to measure effectiveness in the context of routine clinical practice, and requires collection of health care resources to allow estimation of cost over an equal timeframe for each treatment alternative. In assessing suitability of a trial for economic data collection, the comparator treatment and other protocol factors need to reflect current clinical practice and the trial follow-up must be sufficiently long to capture important costs and effects. The broadest available population and a measure of effectiveness reflecting important benefits for patients are preferred for economic analyses. Special analytical issues include dealing with missing and censored cost data, assessing uncertainty of the incremental cost-effectiveness ratio, and accounting for the underlying heterogeneity in patient subgroups. Careful consideration also needs to be given to data from multinational studies since practice patterns can differ across countries. Although clinical trials can be an efficient opportunity to collect data for economic evaluation, careful consideration of the suitability of the study design, and appropriate analytical methods must be applied to obtain rigorous results.

The Effects of Music Intervention on Background Pain and Anxiety in Burn Patients: Randomized Controlled Clinical Trial.

PubMed

Najafi Ghezeljeh, Tahereh; Mohades Ardebili, Fatimah; Rafii, Forough; Haghani, Hamid

2016-01-01

This study aimed to investigate the effect of music on the background pain, anxiety, and relaxation levels in burn patients. In this pretest-posttest randomized controlled clinical trial, 100 hospitalized burn patients were selected through convenience sampling. Subjects randomly assigned to music and control groups. Data related to demographic and clinical characteristics, analgesics, and physiologic measures were collected by researcher-made tools. Visual analog scale was used to determine pain, anxiety, and relaxation levels before and after the intervention in 3 consecutive days. Patients' preferred music was offered once a day for 3 days. The control group only received routine care. Data were analyzed using SPSS-PC (V. 20.0). According to paired t-test, there were significant differences between mean scores of pain (P < .001), anxiety (P < .001), and relaxation (P < .001) levels before and after intervention in music group. Independent t-test indicated a significant difference between the mean scores of changes in pain, anxiety, and relaxation levels before and after intervention in music and control groups (P < .001). No differences were detected in the mean scores of physiologic measures between groups before and after music intervention. Music is an inexpensive, appropriate, and safe intervention for applying to burn patients with background pain and anxiety at rest. To produce more effective comfort for patients, it is necessary to compare different types and time lengths of music intervention to find the best approach.

Choosing HIV Counseling and Testing Strategies for Outreach Settings: A Randomized Trial.

PubMed

Spielberg, Freya; Branson, Bernard M; Goldbaum, Gary M; Lockhart, David; Kurth, Ann; Rossini, Anthony; Wood, Robert W

2005-03-01

In surveys, clients have expressed preferences for alternatives to traditional HIV counseling and testing. Few data exist to document how offering such alternatives affects acceptance of HIV testing and receipt of test results. This randomized controlled trial compared types of HIV tests and counseling at a needle exchange and 2 bathhouses to determine which types most effectively ensured that clients received test results. Four alternatives were offered on randomly determined days: (1) traditional test with standard counseling, (2) rapid test with standard counseling, (3) oral fluid test with standard counseling, and (4) traditional test with choice of written pretest materials or standard counseling. Of 17,010 clients offered testing, 7014 (41%) were eligible; of those eligible, 761 (11%) were tested: 324 at the needle exchange and 437 at the bathhouses. At the needle exchange, more clients accepted testing (odds ratio [OR] = 2.3; P < 0.001) and received results (OR = 2.6; P < 0.001) on days when the oral fluid test was offered compared with the traditional test. At the bathhouses, more clients accepted oral fluid testing (OR = 1.6; P < 0.001), but more clients overall received results on days when the rapid test was offered (OR = 1.9; P = 0.01). Oral fluid testing and rapid blood testing at both outreach venues resulted in significantly more people receiving test results compared with traditional HIV testing. Making counseling optional increased testing at the needle exchange but not at the bathhouses.

Parent involvement in pain management for NICU infants: a randomized controlled trial.

PubMed

Franck, Linda S; Oulton, Kate; Nderitu, Sue; Lim, Magdalene; Fang, Swee; Kaiser, Anthony

2011-09-01

To demonstrate feasibility and estimate the effect of an intervention to increase parental involvement in infant pain management in the NICU on parents' stress and postdischarge parenting competence and confidence. The study involved a randomized controlled trial. Parents recruited from 4 NICUs were randomly assigned by site to receive (1) a pain information booklet and instruction on infant comforting techniques (n = 84 intervention) in addition to a generic NICU care booklet or (2) the generic NICU care booklet alone (n = 85 control). The primary outcome was postintervention Parent Stressor Scale: NICU (PSS:NICU) scores. Secondary outcomes included parent attitudes about infant pain, nursing pain assessment, and parenting competence and role attainment after discharge. No differences were found between groups in PSS:NICU scores. Significant differences favoring the intervention group were found for satisfaction with pain information, parents shown infant pain cues and comforting techniques, nursing pain assessment, and parent preference for involvement during painful procedures. Role attainment after discharge was higher for the intervention group than for the control group. Both the intervention and control groups highly valued attention to infant pain and wanted information and involvement. These results provide no evidence of a reduction in NICU-related stress for parents who receive an intervention to increase their understanding and involvement in infant pain management. However, parents in the intervention group were better prepared to take an active role in infant pain care and had more positive views about their role attainment in the postdischarge period.

Comparison of the Effects of Benson Muscle Relaxation and Nature Sounds on the Fatigue in Patients With Heart Failure: A Randomized Controlled Clinical Trial.

PubMed

Seifi, Leila; Najafi Ghezeljeh, Tahereh; Haghani, Hamid

This study was conducted with the aim of comparing the effects of Benson muscle relaxation and nature sounds on fatigue in patients with heart failure. Fatigue and exercise intolerance as prevalent symptoms experienced by patients with heart failure can cause the loss of independence in the activities of daily living. It can also damage self-care and increase dependence to others, which subsequently can reduce the quality of life. This randomized controlled clinical trial was conducted in an urban area of Iran in 2016. Samples were consisted of 105 hospitalized patients with heart failure chosen using a convenience sampling method. They were assigned to relaxation, nature sounds, and control groups using a randomized block design. In addition to routine care, the Benson muscle relaxation and nature sounds groups received interventions in mornings and evenings twice a day for 20 minutes within 3 consecutive days. A 9-item questionnaire was used to collect data regarding fatigue before and after the interventions. Relaxation and nature sounds reduced fatigue in patients with heart failure in comparison to the control group. However, no statistically significant difference was observed between the interventions. Benson muscle relaxation and nature sounds are alternative methods for the reduction of fatigue in patients with heart failure. They are inexpensive and easy to be administered and upon patients' preferences can be used by nurses along with routine nursing interventions.

A Systematic Review of Surgical Randomized Controlled Trials: Part 2. Funding Source, Conflict of Interest, and Sample Size in Plastic Surgery.

PubMed

Voineskos, Sophocles H; Coroneos, Christopher J; Ziolkowski, Natalia I; Kaur, Manraj N; Banfield, Laura; Meade, Maureen O; Chung, Kevin C; Thoma, Achilleas; Bhandari, Mohit

2016-02-01

The authors examined industry support, conflict of interest, and sample size in plastic surgery randomized controlled trials that compared surgical interventions. They hypothesized that industry-funded trials demonstrate statistically significant outcomes more often, and randomized controlled trials with small sample sizes report statistically significant results more frequently. An electronic search identified randomized controlled trials published between 2000 and 2013. Independent reviewers assessed manuscripts and performed data extraction. Funding source, conflict of interest, primary outcome direction, and sample size were examined. Chi-squared and independent-samples t tests were used in the analysis. The search identified 173 randomized controlled trials, of which 100 (58 percent) did not acknowledge funding status. A relationship between funding source and trial outcome direction was not observed. Both funding status and conflict of interest reporting improved over time. Only 24 percent (six of 25) of industry-funded randomized controlled trials reported authors to have independent control of data and manuscript contents. The mean number of patients randomized was 73 per trial (median, 43, minimum, 3, maximum, 936). Small trials were not found to be positive more often than large trials (p = 0.87). Randomized controlled trials with small sample size were common; however, this provides great opportunity for the field to engage in further collaboration and produce larger, more definitive trials. Reporting of trial funding and conflict of interest is historically poor, but it greatly improved over the study period. Underreporting at author and journal levels remains a limitation when assessing the relationship between funding source and trial outcomes. Improved reporting and manuscript control should be goals that both authors and journals can actively achieve.

The phylogenetic roots of cognitive dissonance.

PubMed

West, Samantha; Jett, Stephanie E; Beckman, Tamra; Vonk, Jennifer

2010-11-01

We presented 7 Old World monkeys (Japanese macaques [Macaca fuscata], gray-cheeked mangabey [Lophocebus albigena], rhesus macaques [Macaca mulatta], bonnet macaque [Macaca radiate], and olive baboon [Papio anubis]), 3 chimpanzees (Pan troglodytes), 6 members of the parrot (Psittacinae) family, and 4 American black bears (Ursus americanus) with a cognitive dissonance paradigm modeled after Egan, Santos, and Bloom (2007). In experimental trials, subjects were given choices between 2 equally preferred food items and then presented with the unchosen option and a novel, equally preferred food item. In control trials, subjects were presented with 1 accessible and 1 inaccessible option from another triad of equally preferred food items. They were then presented with the previously inaccessible item and a novel member of that triad. Subjects, as a whole, did not prefer the novel item in experimental or control trials. However, there was a tendency toward a subject by condition interaction. When analyzed by primate versus nonprimate categories, only primates preferred the novel item in experimental but not control trials, indicating that they resolved cognitive dissonance by devaluing the unchosen option only when an option was derogated by their own free choice. This finding suggests that this phenomenon might exist within but not outside of the primate order. (PsycINFO Database Record (c) 2010 APA, all rights reserved).

A systematic appraisal of allegiance effect in randomized controlled trials of psychotherapy.

PubMed

Dragioti, Elena; Dimoliatis, Ioannis; Fountoulakis, Konstantinos N; Evangelou, Evangelos

2015-01-01

Experimenter's allegiance (EA) refers to a personal confidence of the superiority of a specific psychotherapy treatment. This factor has been linked with larger treatment effects in favor of the preferred treatment. However, various studies have displayed contradictory results between EA and the pattern of treatment effects. Using a systematic approach followed by meta-analysis, we aimed to evaluate the impact of an allegiance effect on the results of psychotherapeutic studies. We considered the meta-analyses of randomized controlled trials (RCTs) of different types of psychotherapies in the Cochrane Database of Systematic Reviews. Eligible articles included meta-analyses of RCTs with at least one study showing evidence of EA (i.e., allegiant study). Effect sizes in allegiant RCTs were compared with non-allegiant using random and fixed models and a summary relative odds ratio (ROR) were calculated. Heterogeneity was quantified with the I (2) metric. A total of 30 meta-analyses including 240 RCTs were analyzed. The summary ROR was 1.31 [(95 % confidence interval (CI: 1.03-1.66) P = 0.30, I (2) = 53 %] indicating larger effects when allegiance exists. The impact of allegiance did not differ significantly (P > 0.05) when we compared psychiatric versus medical outcomes. Allegiance effect was significant for all forms of psychotherapy except for cognitive behavioral therapy. Moreover, the impact of allegiance was significant only when the treatment integrity of delivered psychotherapy was not assessed. Allegiance effect was even stronger where the experimenter was also both the developer of the preferred treatment and supervised or trained the therapists. No significant differences were found between allegiant and non-allegiant studies in terms of overall quality of studies. Experimenter's allegiance influences the effect sizes of psychotherapy RCTs and can be considered non-financial conflict of interest introducing a form of optimism bias, especially since blinding is problematic in this kind of research. A clear reporting of EA in every single study should be given an opportunity to investigators of minimizing its overestimation effects.

Jail-to-community treatment continuum for adults with co-occurring substance use and mental disorders: study protocol for a pilot randomized controlled trial.

PubMed

Van Dorn, Richard A; Desmarais, Sarah L; Rade, Candalyn B; Burris, Elizabeth N; Cuddeback, Gary S; Johnson, Kiersten L; Tueller, Stephen J; Comfort, Megan L; Mueser, Kim T

2017-08-04

Adults with co-occurring mental and substance use disorders (CODs) are overrepresented in jails. In-custody barriers to treatment, including a lack of evidence-based treatment options and the often short periods of incarceration, and limited communication between jails and community-based treatment agencies that can hinder immediate enrollment into community care once released have contributed to a cycle of limited treatment engagement, unaddressed criminogenic risks, and (re)arrest among this vulnerable and high-risk population. This paper describes a study that will develop research and communication protocols and adapt two evidence-based treatments, dual-diagnosis motivational interviewing (DDMI) and integrated group therapy (IGT), for delivery to adults with CODs across a jail-to-community treatment continuum. Adaptations to DDMI and IGT were guided by the Risk-Need-Responsivity model and the National Institute of Corrections' implementation competencies; the development of the implementation framework and communication protocols were guided by the Evidence-Based Interagency Implementation Model for community corrections and the Inter-organizational Relationship model, respectively. Implementation and evaluation of the protocols and adapted interventions will occur via an open trial and a pilot randomized trial. The clinical intervention consists of two in-jail DDMI sessions and 12 in-community IGT sessions. Twelve adults with CODs and four clinicians will participate in the open trial to evaluate the acceptability and feasibility of, and fidelity to, the interventions and research and communication protocols. The pilot controlled trial will be conducted with 60 inmates who will be randomized to either DDMI-IGT or treatment as usual. A baseline assessment will be conducted in jail, and four community-based assessments will be conducted during a 6-month follow-up period. Implementation, clinical, public health, and treatment preference outcomes will be evaluated. Findings have the potential to improve both jail- and community-based treatment services for adults with CODs as well as inform methods for conducting rigorous pilot implementation and evaluation research in correctional settings and as inmates re-enter the community. Findings will contribute to a growing area of work focused on interrupting the cycle of limited treatment engagement, unaddressed criminogenic risks, and (re)arrest among adults with CODs. ClinicalTrials.gov, NCT02214667 . Registered on 10 August 2014.

A test of the occupational matching hypothesis for rehabilitation clients with severe mental illness.

PubMed

Bond, Gary R; Campbell, Kikuko; Becker, Deborah R

2013-06-01

This study compared job matching rates for clients with severe mental illness enrolled in two types of employment programs. Also examined was the occupational matching hypothesis that job matching is associated with better employment outcomes. The study involved a secondary analysis of a randomized controlled trial comparing evidence-based supported employment to a diversified placement approach. The study sample consisted of 187 participants, of whom 147 obtained a paid job during the 2-year follow-up. Jobs were coded using the Dictionary of Occupational Titles classification system. Match between initial job preferences and type of job obtained was the predictor variable. Outcomes included time to job start, job satisfaction, and job tenure on first job. Most occupational preferences were for clerical and service jobs, and most participants obtained employment in these two occupational domains. In most cases, the first job obtained matched a participant's occupational preference. The occupational matching hypothesis was not supported for any employment outcome. The occupational matching rate was similar in this study to previous studies. Most clients who obtain employment with the help of evidence-based supported employment or diversified placement services find jobs matching their occupational preference, and most often it is a rough match. Occupational matching is but one aspect of job matching; it may be time to discard actuarial classification systems such as the Dictionary of Occupational Titles as a basis for assessing job match.

Alcohol discrimination and preferences in two species of nectar-feeding primate

PubMed Central

Brown, Michael B.; Dominy, Nathaniel J.

2016-01-01

Recent reports suggest that dietary ethanol, or alcohol, is a supplemental source of calories for some primates. For example, slow lorises (Nycticebus coucang) consume fermented nectars with a mean alcohol concentration of 0.6% (range: 0.0–3.8%). A similar behaviour is hypothesized for aye-ayes (Daubentonia madagascariensis) based on a single point mutation (A294V) in the gene that encodes alcohol dehydrogenase class IV (ADH4), the first enzyme to catabolize alcohol during digestion. The mutation increases catalytic efficiency 40-fold and may confer a selective advantage to aye-ayes that consume the nectar of Ravenala madagascariensis. It is uncertain, however, whether alcohol exists in this nectar or whether alcohol is preferred or merely tolerated by nectarivorous primates. Here, we report the results of a multiple-choice food preference experiment with two aye-ayes and a slow loris. We conducted observer-blind trials with randomized, serial dilutions of ethanol (0–5%) in a standard array of nectar-simulating sucrose solutions. We found that both species can discriminate varying concentrations of alcohol; and further, that both species prefer the highest available concentrations. These results bolster the hypothesized adaptive function of the A294V mutation in ADH4, and a connection with fermented foods, both in aye-ayes and the last common ancestor of African apes and humans. PMID:27493777

The 30-second effect: an experiment revealing the impact of television commercials on food preferences of preschoolers.

PubMed

Borzekowski, D L; Robinson, T N

2001-01-01

To examine whether televised food commercials influence preschool children's food preferences. In this randomized, controlled trial, preschool children viewed a videotape of a popular children's cartoon either with or without embedded commercials. Children were then asked to identify their preferences from pairs of similar products, one of which was advertised in the videotape with embedded commercials. Preschoolers' parents were interviewed to determine children's demographic characteristics and media use patterns. Forty-six 2- to 6-year-olds from a Head Start program in northern California. For demographic and media use characteristics, univariate data were examined and Student t and chi 2 tests were used to test for differences between the control and treatment groups. We calculated the Cochran Q statistic to assess whether the proportion of those choosing advertised food items was significantly higher in the treatment group than in the control group. Children exposed to the videotape with embedded commercials were significantly more likely to choose the advertised items than children who saw the same videotape without commercials (Qdiff = 8.13, df = 1, P < .01). Even brief exposures to televised food commercials can influence preschool children's food preferences. Nutritionists and health educators should advise parents to limit their preschooler's exposure to television advertisements. Furthermore, advocates should raise the public policy issue of advertising and young children, especially given the recent epidemic of childhood obesity and the ever-changing media environment.

What determines patient preferences for treating low risk basal cell carcinoma when comparing surgery vs imiquimod? A discrete choice experiment survey from the SINS trial.

PubMed

Tinelli, Michela; Ozolins, Mara; Bath-Hextall, Fiona; Williams, Hywel C

2012-10-04

The SINS trial (Controlled Clinical Trials ISRCTN48755084; Eudract No. 2004-004506-24) is a randomised controlled trial evaluating long term success of excisional surgery vs. imiquimod 5% cream for low risk nodular and superficial basal cell carcinoma (BCC). The trial included a discrete choice experiment questionnaire to explore patient preferences of a cream versus surgery for the treatment of their skin cancer. The self-completed questionnaire was administered at baseline to 183 participants, measuring patients' strength of preferences when choosing either alternative 'surgery' or 'imiquimod cream' instead of a fixed 'current situation' option (of surgical excision as standard practice in UK). The treatments were described according to: cost, chance of complete clearance, side effects and appearance. Participants had to choose between various scenarios. Analysis was performed using a mixed logit model, which took into account the impact of previous BCC treatment and sample preference variability. The analysis showed that respondents preferred 'imiquimod cream' to their 'current situation' or 'surgery', regardless of previous experience of BCC symptoms and treatment. Respondents were more likely to be worried about their cosmetic outcomes and side effects they might experience over and above their chance of clearance and cost. Those with no experience of surgery (compared with experience) valued more the choice of 'imiquimod cream' (£1013 vs £781). All treatment characteristics were significant determinants of treatment choice, and there was significant variability in the population preferences for all of them. Patients with BCC valued more 'imiquimod cream' than alternative 'surgery' options, and all treatment characteristics were important for their choice of care. Understanding how people with a BCC value alternative interventions may better inform the development of health care interventions.

Which Questionnaire Should Be Used to Measure Quality-of-Life Utilities in Patients with Acute Leukemia? An Evaluation of the Validity and Interpretability of the EQ-5D-5L and Preference-Based Questionnaires Derived from the EORTC QLQ-C30.

PubMed

van Dongen-Leunis, Annemieke; Redekop, W Ken; Uyl-de Groot, Carin A

The aim of this study was to assess the validity and interpretability of different preference-based questionnaires (generic 5-level EuroQol five-dimensional questionnaire [EQ-5D-5L], cancer-specific Quality of Life Questionnaire Preference-Based Measure, and European Organization of Randomized Controlled Trials 8 Dimension [EORTC-8D]) in patients with acute leukemia. Patients who participated in Hemato-Oncologie voor Volwassenen Nederland (HOVON - the Haemato Oncology Foundation for Adults in the Netherlands) clinical trials between 1999 and 2011 at a single hospital were invited to complete the questionnaires. Interpretability was evaluated by the frequency of incomplete data and highest and lowest possible scores. Content validity was evaluated by exploring the health-related quality-of-life domains included in the questionnaires. Construct validity was assessed using correlations with other quality-of-life scales (EQ-visual analogue scale score and global quality-of-life scale of the EORTC Quality of Life Questionnaire) and ability to distinguish between patients with different health statuses. Questionnaires were returned by 89% (111 of 125) of the patients. Six to seven respondents did not return full questionnaires. Perfect health on the EQ-5D-5L was reported by 32 respondents and many of them (N = 17) did report health problems on other questionnaires. All questionnaires were strongly correlated (range 0.61-0.78) with other quality-of-life scales and yielded substantially different utility values for patients with different health statuses. Nevertheless, the disease-specific preference-based questionnaires showed greater discriminatory power. Although the Quality of Life Questionnaire Preference-Based Measure and the EORTC-8D appear to have better validity, this study does not provide any strong evidence against the use of the EQ-5D-5L for measuring quality-of-life utilities in acute leukemia. However, our findings need to be confirmed in larger longitudinal studies. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Advance care planning uptake among patients with severe lung disease: a randomised patient preference trial of a nurse-led, facilitated advance care planning intervention.

PubMed

Sinclair, Craig; Auret, Kirsten Anne; Evans, Sharon Frances; Williamson, Fiona; Dormer, Siobhan; Wilkinson, Anne; Greeve, Kim; Koay, Audrey; Price, Dot; Brims, Fraser

2017-02-24

Advance care planning (ACP) clarifies goals for future care if a patient becomes unable to communicate their own preferences. However, ACP uptake is low, with discussions often occurring late. This study assessed whether a systematic nurse-led ACP intervention increases ACP in patients with advanced respiratory disease. A multicentre open-label randomised controlled trial with preference arm. Metropolitan teaching hospital and a rural healthcare network. 149 participants with respiratory malignancy, chronic obstructive pulmonary disease or interstitial lung disease. Nurse facilitators offered facilitated ACP discussions, prompted further discussions with doctors and loved ones, and assisted participants to appoint a substitute medical decision-maker (SDM) and complete an advance directive (AD). The primary measure was formal (AD or SDM) or informal (discussion with doctor) ACP uptake assessed by self-report (6 months) and medical notes audit. Secondary measures were the factors predicting baseline readiness to undertake ACP, and factors predicting postintervention ACP uptake in the intervention arm. At 6 months, formal ACP uptake was significantly higher (p<0.001) in the intervention arm (54/106, 51%), compared with usual care (6/43, 14%). ACP discussions with doctors were also significantly higher (p<0.005) in the intervention arm (76/106, 72%) compared with usual care (20/43, 47%). Those with a strong preference for the intervention were more likely to complete formal ACP documents than those randomly allocated. Increased symptom burden and preference for the intervention predicted later ACP uptake. Social support was positively associated with ACP discussion with loved ones, but negatively associated with discussion with doctors. Nurse-led facilitated ACP is acceptable to patients with advanced respiratory disease and effective in increasing ACP discussions and completion of formal documents. Awareness of symptom burden, readiness to engage in ACP and relevant psychosocial factors may facilitate effective tailoring of ACP interventions and achieve greater uptake. ACTRN12614000255684. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Effect of enhanced information, values clarification, and removal of financial barriers on use of prenatal genetic testing: a randomized clinical trial.

PubMed

Kuppermann, Miriam; Pena, Sherri; Bishop, Judith T; Nakagawa, Sanae; Gregorich, Steven E; Sit, Anita; Vargas, Juan; Caughey, Aaron B; Sykes, Susan; Pierce, Lasha; Norton, Mary E

2014-09-24

Prenatal genetic testing guidelines recommend providing patients with detailed information to allow informed, preference-based screening and diagnostic testing decisions. The effect of implementing these guidelines is not well understood. To analyze the effect of a decision-support guide and elimination of financial barriers to testing on use of prenatal genetic testing and decision making among pregnant women of varying literacy and numeracy levels. Randomized trial conducted from 2010-2013 at prenatal clinics at 3 county hospitals, 1 community clinic, 1 academic center, and 3 medical centers of an integrated health care delivery system in the San Francisco Bay area. Participants were English- or Spanish-speaking women who had not yet undergone screening or diagnostic testing and remained pregnant at 11 weeks' gestation (n = 710). A computerized, interactive decision-support guide and access to prenatal testing with no out-of-pocket expense (n = 357) or usual care as per current guidelines (n = 353). The primary outcome was invasive diagnostic test use, obtained via medical record review. Secondary outcomes included testing strategy undergone, and knowledge about testing, risk comprehension, and decisional conflict and regret at 24 to 36 weeks' gestation. Women randomized to the intervention group, compared with those randomized to the control group, were less likely to have invasive diagnostic testing (5.9% vs 12.3%; odds ratio [OR], 0.45 [95% CI, 0.25-0.80]) and more likely to forgo testing altogether (25.6% vs 20.4%; OR, 3.30 [95% CI, 1.43-7.64], reference group screening followed by invasive testing). Women randomized to the intervention group also had higher knowledge scores (9.4 vs 8.6 on a 15-point scale; mean group difference, 0.82 [95% CI, 0.34-1.31]) and were more likely to correctly estimate the amniocentesis-related miscarriage risk (73.8% vs 59.0%; OR, 1.95 [95% CI, 1.39-2.75]) and their estimated age-adjusted chance of carrying a fetus with trisomy 21 (58.7% vs 46.1%; OR, 1.66 [95% CI, 1.22-2.28]). Significant differences did not emerge in decisional conflict or regret. Full implementation of prenatal testing guidelines using a computerized, interactive decision-support guide in the absence of financial barriers to testing resulted in less test use and more informed choices. If validated in additional populations, this approach may result in more informed and preference-based prenatal testing decision making and fewer women undergoing testing. clinicaltrials.gov Identifier: NCT00505596.

Growth Hormone Research Society Workshop Summary: Consensus Guidelines for Recombinant Human Growth Hormone Therapy in Prader-Willi Syndrome

PubMed Central

Tony, Michèle; Höybye, Charlotte; Allen, David B.; Tauber, Maïthé; Christiansen, Jens Sandahl; Ambler, Geoffrey R.; Battista, Renaldo; Beauloye, Véronique; Berall, Glenn; Biller, Beverly M. K.; Butler, Merlin G.; Cassidy, Suzanne B.; Chihara, Kazuo; Cohen, Pinchas; Craig, Maria; Farholt, Stense; Goetghebeur, Mireille; Goldstone, Anthony P.; Greggi, Tiziana; Grugni, Graziano; Hokken-Koelega, Anita C.; Johannsson, Gudmundur; Johnson, Keegan; Kemper, Alex; Kopchick, John J.; Malozowski, Saul; Miller, Jennifer; Mogul, Harriette R.; Muscatelli, Françoise; Nergårdh, Ricard; Nicholls, Robert D.; Radovick, Sally; Rosenthal, M. Sara; Sipilä, Ilkka; Tarride, Jean-Eric; Vogels, Annick; Waters, Michael J.

2013-01-01

Context: Recombinant human GH (rhGH) therapy in Prader-Willi syndrome (PWS) has been used by the medical community and advocated by parental support groups since its approval in the United States in 2000 and in Europe in 2001. Its use in PWS represents a unique therapeutic challenge that includes treating individuals with cognitive disability, varied therapeutic goals that are not focused exclusively on increased height, and concerns about potential life-threatening adverse events. Objective: The aim of the study was to formulate recommendations for the use of rhGH in children and adult patients with PWS. Evidence: We performed a systematic review of the clinical evidence in the pediatric population, including randomized controlled trials, comparative observational studies, and long-term studies (>3.5 y). Adult studies included randomized controlled trials of rhGH treatment for ≥ 6 months and uncontrolled trials. Safety data were obtained from case reports, clinical trials, and pharmaceutical registries. Methodology: Forty-three international experts and stakeholders followed clinical practice guideline development recommendations outlined by the AGREE Collaboration (www.agreetrust.org). Evidence was synthesized and graded using a comprehensive multicriteria methodology (EVIDEM) (http://bit.ly.PWGHIN). Conclusions: Following a multidisciplinary evaluation, preferably by experts, rhGH treatment should be considered for patients with genetically confirmed PWS in conjunction with dietary, environmental, and lifestyle interventions. Cognitive impairment should not be a barrier to treatment, and informed consent/assent should include benefit/risk information. Exclusion criteria should include severe obesity, uncontrolled diabetes mellitus, untreated severe obstructive sleep apnea, active cancer, or psychosis. Clinical outcome priorities should vary depending upon age and the presence of physical, mental, and social disability, and treatment should be continued for as long as demonstrated benefits outweigh the risks. PMID:23543664

Health-related quality of life in senior adults with epilepsy: what we know from randomized clinical trials and suggestions for future research.

PubMed

Martin, Roy; Vogtle, Laura; Gilliam, Frank; Faught, Edward

2003-12-01

The goal of this work was to review the randomized controlled trial (RCT) literature on antiepileptic medication effects on health-related quality of life in seniors with epilepsy. Studies published from 1998 to June 2002 were identified by searching through Medline and the Cochrane Clinical Trials Register. Pre-1998 RCTs identified by Baker et al. [Epilepsia 41 (2003) 1357] were also examined for relevance to the present review. Studies were reviewed if they included a RCT design and included epilepsy patients over the age of 60. A total of 85 clinical trials were reviewed. Of the 85 studies reviewed only 37 RCT studies included patients over the age of 60. However, formal quality-of-life outcome assessment was not performed in any of the RCTs that included senior adults, and only six studies provided formal quantitative analyses of AED effects in the form of adverse events incidence and participant withdrawal rates. For the most part, early study withdrawal rates were substantial for seniors and adverse events were very common. Two studies reporting on the cognitive and behavioral effects of study AEDs indicated only modest impact when AED monotherapy was kept at therapeutic levels. Despite growing appreciation for quality-of-life, issues in the management of epilepsy little current empirical guidance is available for elderly with epilepsy. There exists virtually no information on elderly patient preferences and goals for epilepsy treatment outcomes, and available data primarily concerns younger adults. Despite some encouraging preliminary evidence from this review suggesting that conservative AED treatment may have a more favorable quality of life-related outcome, more conclusive statements await further systematic investigation.

Favorable effects of insulin sensitizers pertinent to peripheral arterial disease in type 2 diabetes: results from the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial.

PubMed

Althouse, Andrew D; Abbott, J Dawn; Sutton-Tyrrell, Kim; Forker, Alan D; Lombardero, Manuel S; Buitrón, L Virginia; Pena-Sing, Ivan; Tardif, Jean-Claude; Brooks, Maria Mori

2013-10-01

The aim of this manuscript was to report the risk of incident peripheral arterial disease (PAD) in a large randomized clinical trial that enrolled participants with stable coronary artery disease and type 2 diabetes and compare the risk between assigned treatment arms. The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial randomly assigned participants to insulin sensitization (IS) therapy versus insulin-providing (IP) therapy for glycemic control. Results showed similar 5-year mortality in the two glycemic treatment arms. In secondary analyses reported here, we examine the effects of treatment assignment on the incidence of PAD. A total of 1,479 BARI 2D participants with normal ankle-brachial index (ABI) (0.91-1.30) were eligible for analysis. The following PAD-related outcomes are evaluated in this article: new low ABI≤0.9, a lower-extremity revascularization, lower-extremity amputation, and a composite of the three outcomes. During an average 4.6 years of follow-up, 303 participants experienced one or more of the outcomes listed above. Incidence of the composite outcome was significantly lower among participants assigned to IS therapy than those assigned to IP therapy (16.9 vs. 24.1%; P<0.001). The difference was significant in time-to-event analysis (hazard ratio 0.66 [95% CI 0.51-0.83], P<0.001) and remained significant after adjustment for in-trial HbA1c (0.76 [0.59-0.96], P=0.02). In participants with type 2 diabetes who are free from PAD, a glycemic control strategy of insulin sensitization may be the preferred therapeutic strategy to reduce the incidence of PAD and subsequent outcomes.

A Cluster-Randomized Trial of Two Strategies to Improve Antibiotic Use for Patients with a Complicated Urinary Tract Infection

PubMed Central

Spoorenberg, Veroniek; Hulscher, Marlies E. J. L.; Geskus, Ronald B.; de Reijke, Theo M.; Opmeer, Brent C.; Prins, Jan M.; Geerlings, Suzanne E.

2015-01-01

Background Up to 50% of hospital antibiotic use is inappropriate and therefore improvement strategies are urgently needed. We compared the effectiveness of two strategies to improve the quality of antibiotic use in patients with a complicated urinary tract infection (UTI). Methods In a multicentre, cluster-randomized trial 19 Dutch hospitals (departments Internal Medicine and Urology) were allocated to either a multi-faceted strategy including feedback, educational sessions, reminders and additional/optional improvement actions, or a competitive feedback strategy, i.e. providing professionals with non-anonymous comparative feedback on the department’s appropriateness of antibiotic use. Retrospective baseline- and post-intervention measurements were performed in 2009 and 2012 in 50 patients per department, resulting in 1,964 and 2,027 patients respectively. Principal outcome measures were nine validated guideline-based quality indicators (QIs) that define appropriate antibiotic use in patients with a complicated UTI, and a QI sumscore that summarizes for each patient the appropriateness of antibiotic use. Results Performance scores on several individual QIs showed improvement from baseline to post-intervention measurements, but no significant differences were found between both strategies. The mean patient’s QI sum score improved significantly in both strategy groups (multi-faceted: 61.7% to 65.0%, P = 0.04 and competitive feedback: 62.8% to 66.7%, P = 0.01). Compliance with the strategies was suboptimal, but better compliance was associated with more improvement. Conclusion The effectiveness of both strategies was comparable and better compliance with the strategies was associated with more improvement. To increase effectiveness, improvement activities should be rigorously applied, preferably by a locally initiated multidisciplinary team. Trial Registration Nederlands Trial Register 1742 PMID:26637169

Impact of different concentrations of an octenidine dihydrochloride mouthwash on salivary bacterial counts: a randomized, placebo-controlled cross-over trial.

PubMed

Lorenz, Katrin; Jockel-Schneider, Yvonne; Petersen, Nicole; Stölzel, Peggy; Petzold, Markus; Vogel, Ulrich; Hoffmann, Thomas; Schlagenhauf, Ulrich; Noack, Barbara

2018-03-02

This bi-centric, placebo-controlled, randomized, evaluator-blinded, incomplete cross-over clinical phase II trial was initialized to identify the most appropriate concentration of octenidine dihydrochloride (OCT) in mouth rinses. Rinses of 0.10, 0.15, and 0.20% OCT were compared to a saline placebo rinse regarding the reduction of salivary bacterial counts (SBCs) in 90 gingivitis patients over 4 days. Changes in plaque (PI) and gingival index (GI), taste perception, and safety issues were evaluated. At baseline, the first OCT (0.10, 0.15, 0.20%) rinse resulted in a decrease of SBC (reduction by 3.63-5.44 log 10 colony forming units [CFU]) compared to placebo (p < 0.001). Differences between OCT concentrations were not verified. After 4 days, the last OCT rinse again resulted in a significant SBC decrease (3.69-4.22 log 10 CFU) compared to placebo (p < 0.001). Overall, SBC reduction between baseline and day 4 was significantly higher in OCT 0.15 and 0.20% groups compared to OCT 0.10% and placebo. Mean GI/PIs were significantly lower in OCT groups than in the placebo group (p < 0.001). Differences in GI/PI between OCT groups were not verified. Adverse effects increased with increasing OCT concentrations. Considering antibacterial efficacy, frequency of adverse events, and user acceptance, 0.10% OCT was identified as the preferred concentration to be used in future clinical trials. Due to its low toxicity and pronounced antibacterial properties, octenidine dihydrochloride (OCT) is a promising candidate for the use in antiseptic mouth rinses. OCT concentrations of 0.10% are recommended for future clinical trials evaluating the plaque-reducing properties of OCT mouth rinses. ( www.clinicaltrials.gov , NCT022138552).

The impact of decision aids to enhance shared decision making for diabetes (the DAD study): protocol of a cluster randomized trial.

PubMed

LeBlanc, Annie; Ruud, Kari L; Branda, Megan E; Tiedje, Kristina; Boehmer, Kasey R; Pencille, Laurie J; Van Houten, Holly; Matthews, Marc; Shah, Nilay D; May, Carl R; Yawn, Barbara P; Montori, Victor M

2012-05-28

Shared decision making contributes to high quality healthcare by promoting a patient-centered approach. Patient involvement in selecting the components of a diabetes medication program that best match the patient's values and preferences may also enhance medication adherence and improve outcomes. Decision aids are tools designed to involve patients in shared decision making, but their adoption in practice has been limited. In this study, we propose to obtain a preliminary estimate of the impact of patient decision aids vs. usual care on measures of patient involvement in decision making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and resource utilization. In addition, we propose to identify, describe, and explain factors that promote or inhibit the routine embedding of decision aids in practice. We will be conducting a mixed-methods study comprised of a cluster-randomized, practical, multicentered trial enrolling clinicians and their patients (n = 240) with type 2 diabetes from rural and suburban primary care practices (n = 8), with an embedded qualitative study to examine factors that influence the incorporation of decision aids into routine practice. The intervention will consist of the use of a decision aid (Statin Choice and Aspirin Choice, or Diabetes Medication Choice) during the clinical encounter. The qualitative study will include analysis of video recordings of clinical encounters and in-depth, semi-structured interviews with participating patients, clinicians, and clinic support staff, in both trial arms. Upon completion of this trial, we will have new knowledge about the effectiveness of diabetes decision aids in these practices. We will also better understand the factors that promote or inhibit the successful implementation and normalization of medication choice decision aids in the care of chronic patients in primary care practices. NCT00388050.

GrowthHormone Research Society workshop summary: consensus guidelines for recombinant human growth hormone therapy in Prader-Willi syndrome.

PubMed

Deal, Cheri L; Tony, Michèle; Höybye, Charlotte; Allen, David B; Tauber, Maïthé; Christiansen, Jens Sandahl

2013-06-01

Recombinant human GH (rhGH) therapy in Prader-Willi syndrome (PWS) has been used by the medical community and advocated by parental support groups since its approval in the United States in 2000 and in Europe in 2001. Its use in PWS represents a unique therapeutic challenge that includes treating individuals with cognitive disability, varied therapeutic goals that are not focused exclusively on increased height, and concerns about potential life-threatening adverse events. The aim of the study was to formulate recommendations for the use of rhGH in children and adult patients with PWS. We performed a systematic review of the clinical evidence in the pediatric population, including randomized controlled trials, comparative observational studies, and long-term studies (>3.5 y). Adult studies included randomized controlled trials of rhGH treatment for ≥ 6 months and uncontrolled trials. Safety data were obtained from case reports, clinical trials, and pharmaceutical registries. Forty-three international experts and stakeholders followed clinical practice guideline development recommendations outlined by the AGREE Collaboration (www.agreetrust.org). Evidence was synthesized and graded using a comprehensive multicriteria methodology (EVIDEM) (http://bit.ly.PWGHIN). Following a multidisciplinary evaluation, preferably by experts, rhGH treatment should be considered for patients with genetically confirmed PWS in conjunction with dietary, environmental, and lifestyle interventions. Cognitive impairment should not be a barrier to treatment, and informed consent/assent should include benefit/risk information. Exclusion criteria should include severe obesity, uncontrolled diabetes mellitus, untreated severe obstructive sleep apnea, active cancer, or psychosis. Clinical outcome priorities should vary depending upon age and the presence of physical, mental, and social disability, and treatment should be continued for as long as demonstrated benefits outweigh the risks.

Optimal global value of information trials: better aligning manufacturer and decision maker interests and enabling feasible risk sharing.

PubMed

Eckermann, Simon; Willan, Andrew R

2013-05-01

Risk sharing arrangements relate to adjusting payments for new health technologies given evidence of their performance over time. Such arrangements rely on prospective information regarding the incremental net benefit of the new technology, and its use in practice. However, once the new technology has been adopted in a particular jurisdiction, randomized clinical trials within that jurisdiction are likely to be infeasible and unethical in the cases where they would be most helpful, i.e. with current evidence of positive while uncertain incremental health and net monetary benefit. Informed patients in these cases would likely be reluctant to participate in a trial, preferring instead to receive the new technology with certainty. Consequently, informing risk sharing arrangements within a jurisdiction is problematic given the infeasibility of collecting prospective trial data. To overcome such problems, we demonstrate that global trials facilitate trialling post adoption, leading to more complete and robust risk sharing arrangements that mitigate the impact of costs of reversal on expected value of information in jurisdictions who adopt while a global trial is undertaken. More generally, optimally designed global trials offer distinct advantages over locally optimal solutions for decision makers and manufacturers alike: avoiding opportunity costs of delay in jurisdictions that adopt; overcoming barriers to evidence collection; and improving levels of expected implementation. Further, the greater strength and translatability of evidence across jurisdictions inherent in optimal global trial design reduces barriers to translation across jurisdictions characteristic of local trials. Consequently, efficiently designed global trials better align the interests of decision makers and manufacturers, increasing the feasibility of risk sharing and the expected strength of evidence over local trials, up until the point that current evidence is globally sufficient.

Use and Effectiveness of a Video- and Text-Driven Web-Based Computer-Tailored Intervention: Randomized Controlled Trial

PubMed Central

Oenema, Anke; Lechner, Lilian; de Vries, Hein

2015-01-01

Background Many Web-based computer-tailored interventions are characterized by high dropout rates, which limit their potential impact. Objective This study had 4 aims: (1) examining if the use of a Web-based computer-tailored obesity prevention intervention can be increased by using videos as the delivery format, (2) examining if the delivery of intervention content via participants’ preferred delivery format can increase intervention use, (3) examining if intervention effects are moderated by intervention use and matching or mismatching intervention delivery format preference, (4) and identifying which sociodemographic factors and intervention appreciation variables predict intervention use. Methods Data were used from a randomized controlled study into the efficacy of a video and text version of a Web-based computer-tailored obesity prevention intervention consisting of a baseline measurement and a 6-month follow-up measurement. The intervention consisted of 6 weekly sessions and could be used for 3 months. ANCOVAs were conducted to assess differences in use between the video and text version and between participants allocated to a matching and mismatching intervention delivery format. Potential moderation by intervention use and matching/mismatching delivery format on self-reported body mass index (BMI), physical activity, and energy intake was examined using regression analyses with interaction terms. Finally, regression analysis was performed to assess determinants of intervention use. Results In total, 1419 participants completed the baseline questionnaire (follow-up response=71.53%, 1015/1419). Intervention use declined rapidly over time; the first 2 intervention sessions were completed by approximately half of the participants and only 10.9% (104/956) of the study population completed all 6 sessions of the intervention. There were no significant differences in use between the video and text version. Intervention use was significantly higher among participants who were allocated to an intervention condition that matched their preferred intervention delivery format. There were no significant interaction terms for any of the outcome variables; a match and more intervention use did not result in better intervention effects. Participants with a high BMI and participants who felt involved and supported by the intervention were more likely to use the intervention more often. Conclusions Video delivery of tailored feedback does not increase the use of Web-based computer-tailored interventions. However, intervention use can potentially be increased by delivering intervention content via participants’ preferred intervention delivery format and creating feelings of relatedness. Because more intervention use was not associated with better intervention outcomes, more research is needed to examine the optimum number of intervention sessions in terms of maximizing use and effects. Trial Registration Nederlands Trial Register: NTR3501; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3501 (Archived by WebCite at http://www.webcitation.org/6b2tsH8Pk) PMID:26408488

Power Calculations for Moderators in Multi-Site Cluster Randomized Trials

ERIC Educational Resources Information Center

Spybrook, Jessaca; Kelcey, Ben; Dong, Nianbo

2016-01-01

Cluster randomized trials (CRTs), or studies in which intact groups of individuals are randomly assigned to a condition, are becoming more common in evaluation studies of educational programs. A specific type of CRT in which clusters are randomly assigned to treatment within blocks or sites, known as multisite cluster randomized trials (MSCRTs),…

Sedatives for opiate withdrawal in newborn infants.

PubMed

Osborn, D A; Jeffery, H E; Cole, M J

2002-01-01

Neonatal abstinence syndrome (NAS) due to opiate withdrawal may result in disruption of the mother-infant relationship, sleep-wake abnormalities, feeding difficulties, weight loss and seizures. Treatments used to ameliorate symptoms and reduce morbidity include opiates, sedatives and non-pharmacological treatments. To assess the effectiveness and safety of using a sedative compared to a non-opiate control for NAS due to withdrawal from opiates, and to determine which type of sedative is most effective and safe. The standard search strategy of the Neonatal Review Group was used. This included searches of the Cochrane Controlled Trials Register (The Cochrane Library, Issue 1, 2002) and MEDLINE 1966-2002. Trials enrolling infants with NAS born to mothers with an opiate dependence, with > 80% follow up and using random or quasi-random allocation to sedative or control. Control could include another sedative or non-pharmacological treatment. Each author assessed study quality and extracted data independently. Primary outcomes included treatment failure (failure to achieve symptom control or use of additional drug treatment), seizure occurrence, mortality and neurodevelopment. Treatment effect was expressed using (RR), risk difference (RD), mean difference (MD) and weighted mean difference (WMD). Meta-analysis was performed using a fixed effect model. Five studies enrolling a total of 285 patients met inclusion criteria (Finnegan 1984, Kahn 1969, Kaltenbach 1986, Khoo 1995, Madden 1977); however, two (Finnegan 1984, Kaltenbach 1986) may be sequential reports that include some identical patients. Methodological concerns included the use of quasi-random rather than random patient allocation methods in three studies, and sizeable, largely unexplained differences in reported numbers allocated to each group in three studies. Phenobarbital compared to supportive care alone has not been shown to reduce treatment failure or time to regain birthweight (one study). However, the duration of supportive care required to be given to infants each day was significantly reduced (MD -162.1 minutes/day, 95% CI -249.2, -75.1). Comparing phenobarbital to diazepam, meta-analysis of two studies found that phenobarbital produced a significant reduction in treatment failure (typical RR 0.39, 95% CI 0.24, 0.62). There was no significant difference in duration of treatment or duration of hospital stay. Comparing phenobarbital with chlorpromazine, one study found no significant difference in treatment failure rate. No data for neurodevelopment were available, reported by treatment group as allocated. No trials were eligible that assessed clonidine for NAS. In newborn infants with NAS, there is no evidence that phenobarbital, compared with supportive care alone, reduces treatment failure; however, phenobarbital may reduce the daily duration of supportive care needed. Phenobarbital, compared to diazepam, reduces treatment failure. There is insufficient evidence to support the use of chlorpromazine or clonidine in newborn infants with NAS. Clonidine and chlorpromazine should only be used in the context of a randomised clinical trial. The results of this review, taken in conjunction with the related review, Opiate treatment for opiate withdrawal in newborn infants (Osborn 2002), indicate that treatment with opiates is the preferred initial therapy for NAS. It is hypothesised that this is particularly true for infants whose mothers have used only opiates during pregnancy. If a sedative is used, phenobarbital is preferred to diazepam. The results of an ongoing trial of the addition of phenobarbital to an opiate are awaited.

Effect of Lepidium meyenii Walp. on Semen Parameters and Serum Hormone Levels in Healthy Adult Men: A Double-Blind, Randomized, Placebo-Controlled Pilot Study

PubMed Central

Melnikovova, Ingrid; Fait, Tomas; Kolarova, Michaela; Fernandez, Eloy C.

2015-01-01

Background/Aims. Products of Lepidium meyenii Walp. (maca) are touted worldwide as an alimentary supplement to enhance fertility and restore hormonal balance. Enhancing properties of maca on semen parameters in animals were previously reported by various authors, but we present to the best of our knowledge the first double-blind, randomized, placebo-controlled pilot trial in men. The aim of this study was to evaluate the effects of maca on semen parameters and serum hormone levels in healthy adult men. Methods. A group of 20 volunteers aged 20–40 years was supplied by milled hypocotyl of maca or placebo (1.75 g/day) for 12 weeks. Negative controls of semen were compared to the samples after 6 and 12 weeks of maca administration; negative blood controls were compared to the samples after 12 weeks of treatment. Results. Sperm concentration and motility showed rising trends compared to placebo even though levels of hormones did not change significantly after 12 weeks of trial. Conclusion. Our results indicate that maca possesses fertility enhancing properties in men. As long as men prefer to use alimentary supplement to enhance fertility rather than prescribed medication or any medical intervention, it is worth continuing to assess its possible benefits. PMID:26421049

Allogeneic Transplantation: Peripheral Blood versus Bone Marrow

PubMed Central

Bensinger, William I.

2013-01-01

Purpose of Review Peripheral Blood Stem Cells (PBSC) have been widely adopted as a source of stem cells for allogeneic transplantation although controversy remains regarding their role compared to the use of bone marrow (BM). Recent Findings Ten year follow-up has been reported from several large randomized trials and a recently completed trial using unrelated donor stem cells have been reported. In addition, two meta-analyses have been reported from the findings of a number of randomized studies. Several studies indicate that PBSC confer survival advantages over BM with matched sibling donors for most disease categories except where the risks of disease recurrence within the first year are low, but with the extra risk of more chronic GVHD. Using PBSC from unrelated donors does not appear to be more beneficial than BM, but with early follow-up. New strategies for rapid mobilization of PBSC from normal donors using plerixafor have been reported. Early studies suggest that filgrastim stimulated BM may confer some of the advantages of PBSC without the risks of chronic GVHD. Summary PBSC are a preferred source of stem cells for many types of allogeneic transplant where matched related donors are available. Whether the same benefits accrue from unrelated donors will require further follow-up. PMID:22185938

Effect of Lepidium meyenii Walp. on Semen Parameters and Serum Hormone Levels in Healthy Adult Men: A Double-Blind, Randomized, Placebo-Controlled Pilot Study.

PubMed

Melnikovova, Ingrid; Fait, Tomas; Kolarova, Michaela; Fernandez, Eloy C; Milella, Luigi

2015-01-01

Background/Aims. Products of Lepidium meyenii Walp. (maca) are touted worldwide as an alimentary supplement to enhance fertility and restore hormonal balance. Enhancing properties of maca on semen parameters in animals were previously reported by various authors, but we present to the best of our knowledge the first double-blind, randomized, placebo-controlled pilot trial in men. The aim of this study was to evaluate the effects of maca on semen parameters and serum hormone levels in healthy adult men. Methods. A group of 20 volunteers aged 20-40 years was supplied by milled hypocotyl of maca or placebo (1.75 g/day) for 12 weeks. Negative controls of semen were compared to the samples after 6 and 12 weeks of maca administration; negative blood controls were compared to the samples after 12 weeks of treatment. Results. Sperm concentration and motility showed rising trends compared to placebo even though levels of hormones did not change significantly after 12 weeks of trial. Conclusion. Our results indicate that maca possesses fertility enhancing properties in men. As long as men prefer to use alimentary supplement to enhance fertility rather than prescribed medication or any medical intervention, it is worth continuing to assess its possible benefits.

Acute effects of violent video-game playing on blood pressure and appetite perception in normal-weight young men: a randomized controlled trial.

PubMed

Siervo, M; Sabatini, S; Fewtrell, M S; Wells, J C K

2013-12-01

Watching television and playing video game being seated represent sedentary behaviours and increase the risk of weight gain and hypertension. We investigated the acute effects of violent and non-violent video-game playing on blood pressure (BP), appetite perception and food preferences. Forty-eight young, normal-weight men (age: 23.1±1.9 years; body mass index: 22.5±1.9 kg/m(2)) participated in a three-arm, randomized trial. Subjects played a violent video game, a competitive, non-violent video game or watched TV for 1 h. Measurements of BP, stress and appetite perception were recorded before a standardized meal (∼300 kcal) and then repeated every 15 min throughout the intervention. Violent video-game playing was associated with a significant increase in diastolic BP (Δ±s.d.=+7.5±5.8 mm Hg; P=0.04) compared with the other two groups. Subjects playing violent video games felt less full (P=0.02) and reported a tendency towards sweet food consumption. Video games involving violence appear to be associated with significant effects on BP and appetite perceptions compared with non-violent gaming or watching TV.

VAGINAL PROGESTERONE VERSUS CERVICAL CERCLAGE FOR THE PREVENTION OF PRETERM BIRTH IN WOMEN WITH A SONOGRAPHIC SHORT CERVIX, SINGLETON GESTATION, AND PREVIOUS PRETERM BIRTH: A SYSTEMATIC REVIEW AND INDIRECT COMPARISON META-ANALYSIS

PubMed Central

CONDE-AGUDELO, Agustin; ROMERO, Roberto; NICOLAIDES, Kypros; CHAIWORAPONGSA, Tinnakorn; O'BRIEN, John M.; CETINGOZ, Elcin; DA FONSECA, Eduardo; CREASY, George; SOMA-PILLAY, Priya; FUSEY, Shalini; CAM, Cetin; ALFIREVIC, Zarko; HASSAN, Sonia S.

2012-01-01

OBJECTIVE No randomized controlled trial has directly compared vaginal progesterone and cervical cerclage for the prevention of preterm birth in women with a sonographic short cervix in the midtrimester, singleton gestation, and previous spontaneous preterm birth. We performed an indirect comparison of vaginal progesterone versus cerclage, using placebo/no cerclage as the common comparator. STUDY DESIGN Adjusted indirect meta-analysis of randomized controlled trials. RESULTS Four studies evaluating vaginal progesterone versus placebo (158 patients) and five evaluating cerclage versus no cerclage (504 patients) were included. Both interventions were associated with a statistically significant reduction in the risk of preterm birth <32 weeks of gestation and composite perinatal morbidity and mortality compared with placebo/no cerclage. Adjusted indirect meta-analyses did not show statistically significant differences between vaginal progesterone and cerclage in reducing preterm birth or adverse perinatal outcomes. CONCLUSION Based on state-of-the-art methodology for indirect comparisons, either vaginal progesterone or cerclage are equally efficacious in the prevention of preterm birth in women with a sonographic short cervix in the midtrimester, singleton gestation, and previous preterm birth. The selection of the optimal treatment may depend upon adverse events, cost and patient/clinician preferences. PMID:23157855

A randomized trial of pictorial versus prose-based medication information pamphlets.

PubMed

Thompson, Andrew E; Goldszmidt, Mark A; Schwartz, Alan J; Bashook, Philip G

2010-03-01

The goal of this study was to compare prose and pictorial-based information pamphlets about the medication methotrexate in the domains of free recall, cued recall, comprehension and utility. A single blind, randomized trial of picture versus prose-based information pamphlets including 100 participants aged 18-65 years of age, who had not completed high school, could read English, and had no prior knowledge about methotrexate. Superiority of pamphlet type was assessed using immediate free recall, cued recall and comprehension. There were no differences between picture and prose pamphlets in free recall, cued recall, and comprehension either immediately or after a 1-week interval. Immediate free recall of important information was 17-26%; free recall fell even lower to 7-16% after 1 week. The pictorial pamphlet was preferred over the prose-based pamphlet. This study found no benefit in free recall, cued recall, or comprehension through the addition of pictograms to a simple prose-based medication pamphlet. In order for them to be effective in clinical practice, even simple medication information pamphlets that have been assessed for patients' ability to comprehend them cannot be used as the sole means for conveying important medication-related information to patients. Copyright 2010 Elsevier Ireland Ltd. All rights reserved.

A randomized single blind crossover trial comparing leather and commercial wrist splints for treating chronic wrist pain in adults

PubMed Central

Thiele, Jill; Nimmo, Rachel; Rowell, Wendy; Quinn, Stephen; Jones, Graeme

2009-01-01

Background To compare the effectiveness of a custom-made leather wrist splint (LS) with a commercially available fabric splint (FS) in adults with chronic wrist pain. Methods Participants (N = 25, mean age = 54) were randomly assigned to treatment order in a 2-phase crossover trial. Splints were worn for 2 weeks, separated by a one-week washout period. Outcomes were assessed at baseline and after each splint phase using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN), the Canadian Occupational Performance Measure (COPM) and Jamar dynamometer by an observer blinded to treatment allocation. Results Both styles of wrist splint significantly reduced pain (effect size LS 0.79, FS 0.43), improved hand function and increased grip strength compared to baseline (all p < 0.05) with no increase in wrist stiffness. There was a consistent trend for the LS to be superior to the FS but this was statistically significant only for patient perceived occupational performance (p = 0.008) and satisfaction (p = 0.015). Lastly, 72% of patients preferred the custom-made leather splint compared to the commercially available splint. Conclusion Leather wrist splints were superior to a commercially available fabric splint for the short-term relief of pain and dysfunction. PMID:19843345

A Physical Activity Intervention for Brazilian Students From Low Human Development Index Areas: A Cluster-Randomized Controlled Trial.

PubMed

Filho, Valter C Barbosa; da Silva, Kelly Samara; Mota, Jorge; Beck, Carmem; da Silva Lopes, Adair

2016-11-01

Promoting physical activity (PA) in low- and middle-income countries is an important public health topic as well as a challenge for practice. This study aimed to assess the effect of a school-based intervention on different PA-related variables among students. This cluster-randomized-controlled trial included 548 students in the intervention group and 537 in the control group (11-18 years-old) from 6 schools in neighborhoods with low Human Development Index (0.170-0.491) in Fortaleza, Brazil. The intervention included strategies focused on training teachers, opportunities for PA in the school environment and health education. Variables measured at baseline and again at the 4-months follow-up included the weekly time in different types of moderate-to-vigorous PA (MVPA), preference for PA during leisure-time, PA behavioral change stage and active commuting to school. Generalized linear models and binary logistic regressions were used. An intervention effect was found by increasing the weekly time in MVPA (effect size = 0.17), popular games (effect size = 0.35), and the amount of PA per week (effect size = 0.27) among students (all P < .05). The intervention was effective in promoting improvements in some PA outcomes, but the changes were not sufficient to increase the proportion of those meeting PA recommendations.

Context-specific control and context selection in conflict tasks.

PubMed

Schouppe, Nathalie; Ridderinkhof, K Richard; Verguts, Tom; Notebaert, Wim

2014-02-01

This study investigated whether participants prefer contexts with relatively little cognitive conflict and whether this preference is related to context-specific control. A conflict selection task was administered in which participants had to choose between two categories that contained different levels of conflict. One category was associated with 80% congruent Stroop trials and 20% incongruent Stroop trials, while the other category was associated with only 20% congruent Stroop trials and 80% incongruent Stroop trials. As predicted, participants selected the low-conflict category more frequently, indicating that participants avoid contexts with high-conflict likelihood. Furthermore, we predicted a correlation between this preference for the low-conflict category and the control implementation associated with the categories (i.e., context-specific proportion congruency effect, CSPC effect). Results however did not show such a correlation, thereby failing to support a relationship between context control and context selection. Copyright © 2013 Elsevier B.V. All rights reserved.

A mental health intervention strategy for low-income, trauma-exposed Latina immigrants in primary care

PubMed Central

Kaltman, Stacey; de Mendoza, Alejandra Hurtado; Serrano, Adriana; Gonzales, Felisa A.

2016-01-01

Latinos in the United States face significant mental health disparities related to access to care, quality of care, and outcomes. Prior research suggests that Latinos prefer to receive care for common mental health problems (e.g., depression and anxiety disorders) in primary care settings, suggesting a need for evidence-based mental health services designed for delivery in these settings. This study sought to develop and preliminarily evaluate a mental health intervention for trauma-exposed Latina immigrants with depression and/or PTSD for primary care clinics that serve the uninsured. The intervention was designed to be simultaneously responsive to patients’ preferences for individual psychotherapy, to the needs of safety-net primary care clinics for efficient services, and to address the social isolation that is common to the Latina immigrant experience. Developed based on findings from the research team’s formative research, the resulting intervention incorporated individual and group sessions and combined evidence-based interventions to reduce depression and PTSD symptoms, increase group readiness, and improve perceived social support. Twenty-eight trauma-exposed low-income Latina immigrant women who screened positive for depression and/or PTSD participated in an open pilot trial of the intervention at a community primary care clinic. Results indicated that the intervention was feasible, acceptable, and safe. A randomized controlled trial of the intervention is warranted. PMID:26913774

The Additional Value of an E-Mail to Inform Healthcare Professionals of a Drug Safety Issue: A Randomized Controlled Trial in the Netherlands.

PubMed

Piening, Sigrid; de Graeff, Pieter A; Straus, Sabine M J M; Haaijer-Ruskamp, Flora M; Mol, Peter G M

2013-09-01

The usefulness and the impact of Direct Healthcare Professional Communications (DHPCs, or 'Dear Doctor letters') in changing the clinical behaviour of physicians have been debated. Changes in the current risk communication methods should preferably be based on the preferences of the healthcare professionals, to optimize the uptake of the message. The aim of this study was to assess whether safety issues are communicated more effectively with an additional e-mail sent by the Dutch Medicines Evaluation Board (MEB) than with the DHPC only. A randomized controlled trial was conducted amongst ophthalmologists and hospital pharmacists in the Netherlands, who were the target group of a DHPC that was issued for pegaptanib, a drug that is administered intra-ocularly in patients with macular degeneration. The intervention group (N = 110) received the pegaptanib DHPC, as well as the MEB e-mail. The control group (N = 105) received the traditional paper-based DHPC only. Two weeks later, the study population received an invitation to fill out an online questionnaire. Questions were asked about the respondents' knowledge and attitude regarding the pegaptanib issue, and any action they had consequently taken. Additional questions were asked about their satisfaction with the DHPC and the e-mail, and their preferred source of such information. Forty respondents (18.6%) completed the questionnaire. Eighty-one percent of the respondents in the intervention group (N = 21) and 47% of the control group (N = 19) correctly indicated that a serious increase in intra-ocular pressure could be caused by pegaptanib injections (Fishers' exact test, p = 0.046). Nine respondents in the intervention group versus none of the control group respondents indicated that they had taken action in response to the pegaptanib safety issue (Fishers' exact test, p = 0.01). The majority of both the intervention group and the control group confirmed that they would like to receive an MEB e-mail with safety information about drugs in the future (90 and 95 %, respectively). The results of this study indicate that an additional e-mail might strengthen the uptake of the safety information provided to healthcare professionals, who prefer to receive an e-mail from the MEB as a source of such information, as well as the DHPC. This study may serve as a starting point for new strategies to improve risk communication regarding safety issues associated with drugs and its impact on prescribing.

Stakeholder Engagement in Trial Design: Survey of Visitors to Critically Ill Patients Regarding Preferences for Outcomes and Treatment Options during Weaning from Mechanical Ventilation.

PubMed

Burns, Karen E A; Jacob, Sonu Karottaiyamvelil; Aguirre, Valeria; Gomes, Janice; Mehta, Sangeeta; Rizvi, Leena

2016-11-01

Stakeholder engagement in research is expected to provide unique insights, make research investments more accountable and transparent, and ensure that future research is applicable to patients and family members. To inform the design of a trial of strategies for weaning from mechanical ventilation, we sought to identify preferences of patient visitors regarding outcome and treatment measures. We conducted an interviewer-administered questionnaire of visitors of critically ill patients in two family waiting rooms serving three intensive care units (ICUs) in Toronto, Canada. Respondents rated the importance of general and ventilation-related outcomes in two hypothetical scenarios (before a first spontaneous breathing trial, and after a failed spontaneous breathing trial) and selected a preferred technique for the breathing trials. With regard to the patient they were visiting, respondents identified the most important outcome to them at ICU admission, during the ICU stay, and at ICU discharge. We analyzed 322 questionnaires (95.5% response rate). All outcomes were highly rated (average range: 7.82-9.74). Across scenarios, outcomes rated as most important were ICU and hospital survival (9.72, 9.70), avoiding complications (9.45), quality of life (9.394), patient comfort (9.393), and returning to previous living arrangements (9.31). Overall, the most important ventilation-related outcomes were being ventilator-free (8.95), avoiding reintubation (8.905), and passing a spontaneous breathing trial (8.903). Passing a spontaneous breathing trial assumed greater importance after an initial failed attempt. "Time to event" outcomes were less important to visitors. We did not identify a preferred spontaneous breathing trial technique. Although ICU survival was the most important outcome at ICU admission and during the ICU stay, visitors rated quality of life higher than hospital survival at ICU discharge. Visitors to critically ill patients prioritized two general outcomes (ICU and hospital survival) and three ventilation-related outcomes (being ventilator free, avoiding reintubation, passing a spontaneous breathing trial), and valued avoiding complications, maintaining quality of life, comfort, and returning to previous living arrangements. The outcomes preferences of the survey respondents evolved temporally during the ICU stay.

Patients' views of consent in clinical trials for acute myocardial infarction: impact of trial design.

PubMed

Dickert, Neal W; Hendershot, Kristopher A; Speight, Candace D; Fehr, Alexandra E

2017-08-01

Seeking prospective informed consent is difficult in clinical trials for emergent conditions such as acute myocardial infarction (AMI). Prior data suggest that enrolment decisions of patients are often poorly informed in AMI trials but that patients prefer to be asked permission before enrolment. It is unknown whether this is true across trial designs or in comparative effectiveness research (CER) with approved treatments. Structured interviews were conducted with 30 patients with AMI. Participants considered three scenarios: (1) a CER trial of approved antiplatelet drugs; (2) a placebo-controlled trial of a novel drug to reduce myocardial injury and (3) a CER trial of an intra-aortic balloon pump versus medication. Participants were asked their desired involvement in enrolment decisions and willingness to participate. Descriptive analysis was performed of Likert scale data, and qualitative descriptive analysis was performed of textual data. Across scenarios, most participants (73%-80%) preferred to be asked permission prior to trial enrolment. Reasons for involvement included wanting to be the decision maker and a desire for transparency. Willingness to enrol was affected by trial type. Fewer participants stated they would likely enrol in a CER procedural trial than in a CER trial of approved medications (p=0.012). These findings suggest that patients prefer prospective involvement in enrolment decisions to enrolment without consent across trial types. However, their desire to participate was affected by trial type. There is a need to develop and evaluate context-sensitive approaches to consent in AMI trials that account for both the acuity of the situation and trial characteristics. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

The effect of alternative graphical displays used to present the benefits of antibiotics for sore throat on decisions about whether to seek treatment: a randomized trial.

PubMed

Carling, Cheryl L L; Kristoffersen, Doris Tove; Flottorp, Signe; Fretheim, Atle; Oxman, Andrew D; Schünemann, Holger J; Akl, Elie A; Herrin, Jeph; MacKenzie, Thomas D; Montori, Victor M

2009-08-01

We conducted an Internet-based randomized trial comparing four graphical displays of the benefits of antibiotics for people with sore throat who must decide whether to go to the doctor to seek treatment. Our objective was to determine which display resulted in choices most consistent with participants' values. This was the first of a series of televised trials undertaken in cooperation with the Norwegian Broadcasting Company. We recruited adult volunteers in Norway through a nationally televised weekly health program. Participants went to our Web site and rated the relative importance of the consequences of treatment using visual analogue scales (VAS). They viewed the graphical display (or no information) to which they were randomized and were asked to decide whether to go to the doctor for an antibiotic prescription. We compared four presentations: face icons (happy/sad) or a bar graph showing the proportion of people with symptoms on day three with and without treatment, a bar graph of the average duration of symptoms, and a bar graph of proportion with symptoms on both days three and seven. Before completing the study, all participants were shown all the displays and detailed patient information about the treatment of sore throat and were asked to decide again. We calculated a relative importance score (RIS) by subtracting the VAS scores for the undesirable consequences of antibiotics from the VAS score for the benefit of symptom relief. We used logistic regression to determine the association between participants' RIS and their choice. 1,760 participants completed the study. There were statistically significant differences in the likelihood of choosing to go to the doctor in relation to different values (RIS). Of the four presentations, the bar graph of duration of symptoms resulted in decisions that were most consistent with the more fully informed second decision. Most participants also preferred this presentation (38%) and found it easiest to understand (37%). Participants shown the other three presentations were more likely to decide to go to the doctor based on their first decision than everyone based on the second decision. Participants preferred the graph using faces the least (14.4%). For decisions about going to the doctor to get antibiotics for sore throat, treatment effects presented by a bar graph showing the duration of symptoms helped people make decisions more consistent with their values than treatment effects presented as graphical displays of proportions of people with sore throat following treatment. ISRCTN58507086.

Psychological and behavioral responses to interval and continuous exercise.

PubMed

Stork, Matthew J; Gibala, Martin J; Martin Ginis, Kathleen A

2018-05-16

To compare psychological responses to, and preferences for, moderate-intensity continuous training (MICT), high-intensity interval training (HIIT), and sprint interval training (SIT) among inactive adults; and to investigate the relationships between affect, enjoyment, exercise preferences, and subsequent exercise behavior over a 4-wk follow-up period. Thirty inactive men and women (21.23±3.81 y), inexperienced with HIIT or SIT, completed three trials of cycle ergometer exercise in random order on separate days: MICT (45min continuous; ~70-75% of heart rate maximum (HRmax)); HIIT (10x1 min bouts at ~85-90%HRmax with 1-min recovery periods); and SIT (3x20-s "all-out" sprints with 2-min recovery periods). Perceived exertion (RPE), affect, and arousal were measured throughout the trials and enjoyment was measured post-exercise. Participants rank-ordered the protocols (#1-3) according to preference and logged their exercise over a 4-week follow-up. Despite elevated HR, RPE, and arousal during work periods (ps<0.05), and negative affect during HIIT and SIT, enjoyment and preferences for MICT, HIIT, and SIT were similar (ps>0.05). In-task affect was predictive of post-exercise enjoyment for each type of exercise (rs=0.32 to 0.47; ps<0.05). In-task affect and post-exercise enjoyment predicted preferences for HIIT and SIT (rss=-0.34 to -0.61; ps<0.05), but not for MICT (ps>0.05), respectively. Over the follow-up, participants completed more MICT (M=6.11±4.12) than SIT sessions (M=1.39±1.85; p<0.01, d=1.34). Although participants tended to complete more sessions of MICT than HIIT (M=3.54±4.23; p=0.16, d=0.56), and more sessions of HIIT than SIT (p=0.07, d=0.60), differences were not significant. In-task affect predicted the number of sessions of MICT (r=0.40; p<0.05), but not HIIT or SIT (ps>0.05). This study provides new evidence that a single session of HIIT and SIT can be as enjoyable and preferable as MICT among inactive individuals and that there may be differences in the exercise affect-behavior relationship between interval and continuous exercise.

Assessments of the quality of randomized controlled trials published in International Journal of Urology from 1994 to 2011.

PubMed

Cho, Hee Ju; Chung, Jae Hoon; Jo, Jung Ki; Kang, Dong Hyuk; Cho, Jeong Man; Yoo, Tag Keun; Lee, Seung Wook

2013-12-01

Randomized controlled trials are one of the most reliable resources for assessing the effectiveness and safety of medical treatments. Low quality randomized controlled trials carry a large bias that can ultimately impair the reliability of their conclusions. The present study aimed to evaluate the quality of randomized controlled trials published in International Journal of Urology by using multiple quality assessment tools. Randomized controlled trials articles published in International Journal of Urology were found using the PubMed MEDLINE database, and qualitative analysis was carried out with three distinct assessment tools: the Jadad scale, the van Tulder scale and the Cochrane Collaboration Risk of Bias Tool. The quality of randomized controlled trials was analyzed by publication year, type of subjects, intervention, presence of funding and whether an institutional review board reviewed the study. A total of 68 randomized controlled trial articles were published among a total of 1399 original articles in International Journal of Urology. Among these randomized controlled trials, 10 (2.70%) were from 1994 to 1999, 23 (4.10%) were from 2000 to 2005 and 35 (4.00%) were from 2006 to 2011 (P = 0.494). On the assessment with the Jadad and van Tulder scale, the numbers and percentage of high quality randomized controlled trials increased over time. The studies that had institutional review board reviews, funding resources or that were carried out in multiple institutions had an increased percentage of high quality articles. The numbers and percentage of high-quality randomized controlled trials published in International Journal of Urology have increased over time. Furthermore, randomized controlled trials with funding resources, institutional review board reviews or carried out in multiple institutions have been found to be of higher quality compared with others not presenting these features. © 2013 The Japanese Urological Association.

Staying well during pregnancy and the postpartum: A pilot randomized trial of mindfulness-based cognitive therapy for the prevention of depressive relapse/recurrence.

PubMed

Dimidjian, Sona; Goodman, Sherryl H; Felder, Jennifer N; Gallop, Robert; Brown, Amanda P; Beck, Arne

2016-02-01

Clinical decision-making regarding the prevention of depression is complex for pregnant women with histories of depression and their health care providers. Pregnant women with histories of depression report preference for nonpharmacological care, but few evidence-based options exist. Mindfulness-based cognitive therapy has strong evidence in the prevention of depressive relapse/recurrence among general populations and indications of promise as adapted for perinatal depression (MBCT-PD). With a pilot randomized clinical trial, our aim was to evaluate treatment acceptability and efficacy of MBCT-PD relative to treatment as usual (TAU). Pregnant adult women with depression histories were recruited from obstetric clinics at 2 sites and randomized to MBCT-PD (N = 43) or TAU (N = 43). Treatment acceptability was measured by assessing completion of sessions, at-home practice, and satisfaction. Clinical outcomes were interview-based depression relapse/recurrence status and self-reported depressive symptoms through 6 months postpartum. Consistent with predictions, MBCT-PD for at-risk pregnant women was acceptable based on rates of completion of sessions and at-home practice assignments, and satisfaction with services was significantly higher for MBCT-PD than TAU. Moreover, at-risk women randomly assigned to MBCT-PD reported significantly improved depressive outcomes compared with participants receiving TAU, including significantly lower rates of depressive relapse/recurrence and lower depressive symptom severity during the course of the study. MBCT-PD is an acceptable and clinically beneficial program for pregnant women with histories of depression; teaching the skills and practices of mindfulness meditation and cognitive-behavioral therapy during pregnancy may help to reduce the risk of depression during an important transition in many women's lives. (c) 2016 APA, all rights reserved).

The Effect on Teenage Risky Driving of Feedback From a Safety Monitoring System: A Randomized Controlled Trial

PubMed Central

Bingham, C. Raymond; Ouimet, Marie Claude; Pradhan, Anuj; Chen, Rusan; Barretto, Andrea; Shope, Jean

2012-01-01

Purpose Teenage risky driving may be due to teenagers not knowing what is risky, preferring risk, or the lack of consequences. Elevated gravitational-force (g-force) events, caused mainly by hard braking and sharp turns, provide a valid measure of risky driving and are the target of interventions using in-vehicle data recording and feedback devices. The effect of two forms of feedback about risky driving events to teenagers only or to teenagers and their parents was tested in a randomized controlled trial. Methods Ninety parent-teen dyads were randomized to one of two groups: (1) immediate feedback to teens (Lights Only); or (2) immediate feedback to teens plus family access to event videos and ranking of the teen relative to other teenage drivers (Lights Plus). Participants’ vehicles were instrumented with data recording devices and events exceeding 0.5 g were assessed for two weeks of baseline and 13 weeks of feedback. Results Growth analysis with random slopes yielded a significant decrease in event rates for the Lights Plus group (slope = −.11, p < 0.01), but no change for the Lights Only group (slope = 0.05, p = 0.67) across the 15 weeks. A large effect size of 1.67 favored the Lights Plus group. Conclusions Provision of feedback with possible consequences associated with parents being informed reduced risky driving, while immediate feedback only to teenagers did not. Implications and Contribution Reducing elevated g-force events due to hard stops and sharp turns could reduce crash rates among novice teenage drivers. Using materials from the DriveCam For Families Program we found that feedback to both teens and parents significantly reduced rates, while feedback only to teens did not. PMID:23375825

Comparative study of four antacids.

PubMed Central

Jacyna, M. R.; Boyd, E. J.; Wormsley, K. G.

1984-01-01

Four antacid preparations have been studied in a stratified, randomized, double-blind trial to evaluate criteria which determine patients' acceptance of this type of therapy. There was a considerable range of judgements about palatability, but preference was determined not only by factors such as the smell, taste, texture and after-taste of the preparation, but also by the order in which the antacids were tested and by the age and sex of the patient. The preparations also differed considerably in acid-neutralizing capacity and ability to bind bile salts, as well as cost. We conclude that individuals requiring antacid therapy should be allowed to chose from among a range of preparations, in order to maximize compliance. PMID:6091079

Screening versus routine practice in detection of atrial fibrillation in patients aged 65 or over: cluster randomised controlled trial

PubMed Central

Fitzmaurice, David A; Jowett, Sue; Mant, Jonathon; Murray, Ellen T; Holder, Roger; Raftery, J P; Bryan, S; Davies, Michael; Lip, Gregory Y H; Allan, T F

2007-01-01

Objectives To assess whether screening improves the detection of atrial fibrillation (cluster randomisation) and to compare systematic and opportunistic screening. Design Multicentred cluster randomised controlled trial, with subsidiary trial embedded within the intervention arm. Setting 50 primary care centres in England, with further individual randomisation of patients in the intervention practices. Participants 14 802 patients aged 65 or over in 25 intervention and 25 control practices. Interventions Patients in intervention practices were randomly allocated to systematic screening (invitation for electrocardiography) or opportunistic screening (pulse taking and invitation for electrocardiography if the pulse was irregular). Screening took place over 12 months in each practice from October 2001 to February 2003. No active screening took place in control practices. Main outcome measure Newly identified atrial fibrillation. Results The detection rate of new cases of atrial fibrillation was 1.63% a year in the intervention practices and 1.04% in control practices (difference 0.59%, 95% confidence interval 0.20% to 0.98%). Systematic and opportunistic screening detected similar numbers of new cases (1.62% v 1.64%, difference 0.02%, −0.5% to 0.5%). Conclusion Active screening for atrial fibrillation detects additional cases over current practice. The preferred method of screening in patients aged 65 or over in primary care is opportunistic pulse taking with follow-up electrocardiography. Trial registration Current Controlled Trials ISRCTN19633732. PMID:17673732

Biologic agents in rheumatology: unmet issues after 200 trials and $200 billion sales.

PubMed

Ioannidis, John P A; Karassa, Fotini B; Druyts, Eric; Thorlund, Kristian; Mills, Edward J

2013-11-01

Anti-TNF agents and other biologic therapies are widely prescribed for a variety of indications, with total sales that exceed $200 billion to date. In rheumatic diseases, biologic agents have now been studied in more than 200 randomized clinical trials and over 100 subsequent meta-analyses; however, the information obtained does not always meet the needs of patients and clinicians. In this Review, we discuss the current issues concerning the evidence derived from such studies: potential biases favouring positive results; a paucity of head-to-head comparisons between biologically active agents; overwhelming involvement of manufacturer sponsors in trials and in the synthesis of the evidence; the preference for trials with limited follow-up; and the potential for spurious findings on adverse events, leading to endless debates about malignancy risk. We debate the responsibilities of regulatory authorities, the pharmaceutical industry and academia in attempting to solve these shortcomings and challenges. We propose that improvements in the evidence regarding biologic treatments that are continually being added to the therapeutic armamentarium for rheumatic diseases might require revisiting the design and conduct of studies. For example, trials with long-term follow-up that are independent of the pharmaceutical industry, head-to-head comparisons of therapeutic agents and the use of rigorous clinical outcomes should be considered, and public availability of raw data endorsed.

Challenges with Evidence-Based Management of Stable Ischemic Heart Disease.

PubMed

Patel, Amit V; Bangalore, Sripal

2017-02-01

Stable ischemic heart disease (SIHD) is a highly prevalent condition associated with increased costs, morbidity, and mortality. Management goals of SIHD can broadly be thought of in terms of improving prognosis and/or improving symptoms. Treatment options include medical therapy as well as revascularization, either with percutaneous coronary intervention or coronary artery bypass grafting. Herein, we will review the current evidence base for treatment of SIHD as well as its challenges and discuss ongoing studies to help address some of these knowledge gaps. There has been no consistent reduction in death or myocardial infarction (MI) with revascularization vs. medical therapy in patients with SIHD in contemporary trials. Angina and quality of life have been shown to be relieved more rapidly with revascularization vs. optimal medical therapy; however, the durability of these results is uncertain. There have been challenges and limitations in several of the trials addressing the optimal treatment strategy for SIHD due to potential selection bias (due to knowledge of coronary anatomy prior to randomization), patient crossover, and advances in medical therapy and revascularization strategies since trial completion. The challenges inherent to prior trials addressing the optimal management strategy for SIHD have impacted the generalizability of results to real-world cohorts. Until the results of additional ongoing trials are available, the decision for revascularization or medical therapy should be based on patients' symptoms, weighing the risks and benefits of each approach, and patient preference.

How Do Urinary Calculi Influence Health-Related Quality of Life and Patient Treatment Preference: A Systematic Review.

PubMed

Raja, Aditya; Hekmati, Zara; Joshi, Hrishi B

2016-07-01

Urinary stone disease is a common and often recurrent condition that can affect kidney function and requires a range of medical and surgical treatments, all of which can have a significant impact on patients' health-related quality of life (HRQoL) and treatment preferences. To review the literature systematically for all studies that include HRQoL measurement or patient preferences in the context of urinary stone disease. Ovid MEDLINE(R), Ovid MEDLINE(R) In-Process, EMBASE, SCOPUS, EconLit, and Web of Science were searched from inception to January 2016. All study designs with adult participants were included. Narrative synthesis was performed. Thirty-five studies met the inclusion criteria (six randomized controlled trials and 29 observational studies) from 15 countries, including 5472 patients. Eleven studies showed that stone formers had worse HRQoL than the general population; it was noted that stone formers were more likely to suffer from depression. Women have significantly lower HRQoL than men. Twenty-six studies used a generic HRQoL measure and six were nonvalidated disease specific. Studies concerning patient preference were heterogeneous and showed that extracorporeal shock wave lithotripsy is still favored above other interventions and that a large number of patients would prefer the treatment pathway to be decided upon by their clinician. Urinary calculi and its treatment can have significant negative patient impact and influence patient preferences. Patients with stone disease tend to have worse physical and mental HRQoL, quantified using generic measures. Structured research with disease-specific measures underpinned by sound methodology would be beneficial and aid in development of patient-centric management. This review was prospectively registered with the international prospective register of systematic reviews-PROSPERO 2013:CRD42013006084.

Does educating patients about the Early Palliative Care Study increase preferences for outpatient palliative cancer care? Findings from Project EMPOWER.

PubMed

Hoerger, Michael; Perry, Laura M; Gramling, Robert; Epstein, Ronald M; Duberstein, Paul R

2017-06-01

Randomized controlled trials, especially the Early Palliative Care Study (Temel et al., 2010), have shown that early outpatient palliative cancer care can improve quality of life for patients with advanced cancer or serious symptoms. However, fear and misconceptions drive avoidance of palliative care. Drawing from an empowerment perspective, we examined whether educating patients about evidence from the Early Palliative Care Study would increase preferences for palliative care. A sample of 598 patients with prostate, breast, lung, colon/rectal, skin, and other cancer diagnoses completed an Internet-mediated experiment using a between-group prepost design. Intervention participants received a summary of the Early Palliative Care Study; controls received no intervention. Participants completed baseline and posttest assessments of preferences of palliative care. Analyses controlled for age, gender, education, cancer type, presence of metastases, time since diagnosis, and baseline preferences. As hypothesized, the intervention had a favorable impact on participants' preferences for outpatient palliative cancer care relative to controls (d = 1.01, p < .001), while controlling for covariates. Intervention participants came to view palliative care as more efficacious (d = 0.79, p < .001) and less scary (d = 0.60, p < .001) and exhibited stronger behavioral intentions to utilize outpatient palliative care if referred (d = 0.60, p < .001). Findings were comparable in patients with metastatic disease, those with less education, and those experiencing financial strain. Educating patients about the Early Palliative Care Study increases preferences for early outpatient palliative care. This research has implications for future studies aimed at improving quality of life in cancer by increasing palliative care utilization. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Preferences for breast cancer risk reduction among BRCA1/BRCA2 mutation carriers: a discrete-choice experiment.

PubMed

Liede, Alexander; Mansfield, Carol A; Metcalfe, Kelly A; Price, Melanie A; Snyder, Carrie; Lynch, Henry T; Friedman, Sue; Amelio, Justyna; Posner, Joshua; Narod, Steven A; Lindeman, Geoffrey J; Evans, D Gareth

2017-09-01

Unaffected women who carry BRCA1 or BRCA2 mutations face difficult choices about reducing their breast cancer risk. Understanding their treatment preferences could help us improve patient counseling and inform drug trials. The objective was to explore preferences for various risk-reducing options among women with germline BRCA1/2 mutations using a discrete-choice experiment survey and to compare expressed preferences with actual behaviors. A discrete-choice experiment survey was designed wherein women choose between hypothetical treatments to reduce breast cancer risk. The hypothetical treatments were characterized by the extent of breast cancer risk reduction, treatment duration, impact on fertility, hormone levels, risk of uterine cancer, and ease and mode of administration. Data were analyzed using a random-parameters logit model. Women were also asked to express their preference between surgical and chemoprevention options and to report on their actual risk-reduction actions. Women aged 25-55 years with germline BRCA1/2 mutations who were unaffected with breast or ovarian cancer were recruited through research registries at five clinics and a patient advocacy group. Between January 2015 and March 2016, 622 women completed the survey. Breast cancer risk reduction was the most important consideration expressed, followed by maintaining fertility. Among the subset of women who wished to have children in future, the ability to maintain fertility was the most important factor, followed by the extent of risk reduction. Many more women said they would take a chemoprevention drug than had actually taken chemoprevention. Women with BRCA1/2 mutations indicated strong preferences for breast cancer risk reduction and maintaining fertility. The expressed desire to have a safe chemoprevention drug available to them was not met by current chemoprevention options.

Consumer preference in ranking walking function utilizing the walking index for spinal cord injury II.

PubMed

Patrick, M; Ditunno, P; Ditunno, J F; Marino, R J; Scivoletto, G; Lam, T; Loffree, J; Tamburella, F; Leiby, B

2011-12-01

Blinded rank ordering. To determine consumer preference in walking function utilizing the walking Index for spinal cord injury II (WISCI II) in individuals with spinal cord injury (SCI)from the Canada, the Italy and the United States of America. In all, 42 consumers with incomplete SCI (25 cervical, 12 thoracic, 5 lumbar) from Canada (12/42), Italy (14/42) and the United States of America (16/42) ranked the 20 levels of the WISCI II scale by their individual preference for walking. Subjects were blinded to the original ranking of the WISCI II scale by clinical scientists. Photographs of each WISCI II level used in a previous pilot study were randomly shuffled and rank ordered. Percentile, conjoint/cluster and graphic analyses were performed. All three analyses illustrated consumer ranking followed a bimodal distribution. Ranking for two levels with physical assistance and two levels with a walker were bimodal with a difference of five to six ranks between consumer subgroups (quartile analysis). The larger cluster (N=20) showed preference for walking with assistance over the smaller cluster (N=12), whose preference was walking without assistance and more devices. In all, 64% (27/42) of consumers ranked WISCI II level with no devices or braces and 1 person assistance higher than multiple levels of the WISCI II requiring no assistance. These results were unexpected, as the hypothesis was that consumers would rank independent walking higher than walking with assistance. Consumer preference for walking function should be considered in addition to objective measures in designing SCI trials that use significant improvement in walking function as an outcome measure.

Bayesian adaptive trials offer advantages in comparative effectiveness trials: an example in status epilepticus.

PubMed

Connor, Jason T; Elm, Jordan J; Broglio, Kristine R

2013-08-01

We present a novel Bayesian adaptive comparative effectiveness trial comparing three treatments for status epilepticus that uses adaptive randomization with potential early stopping. The trial will enroll 720 unique patients in emergency departments and uses a Bayesian adaptive design. The trial design is compared to a trial without adaptive randomization and produces an efficient trial in which a higher proportion of patients are likely to be randomized to the most effective treatment arm while generally using fewer total patients and offers higher power than an analogous trial with fixed randomization when identifying a superior treatment. When one treatment is superior to the other two, the trial design provides better patient care, higher power, and a lower expected sample size. Copyright © 2013 Elsevier Inc. All rights reserved.

Comparison of the analgesic effects of oral tramadol and naproxen sodium on pain relief during IUD insertion.

PubMed

Karabayirli, Safinaz; Ayrim, Aylin Aker; Muslu, Bunyamin

2012-01-01

To compare the analgesic efficacy of oral tramadol and naproxen sodium on pain during insertion of an intrauterine device (IUD). Randomized, double-blinded, clinical trial (Canadian Task Force classification I). University-affiliated hospital. Single-center. One hundred three patients scheduled for insertion of an IUD. Patients were randomly assigned to receive oral tramadol 50 mg capsules (n = 35) or naproxen sodium 550 mg tablets (n = 34) or placebo (n = 34) 1 hour before insertion of the IUD. After insertion of the IUD, pain intensity was evaluated using a visual analog scale (VAS, 0-10). Adverse effects, patient satisfaction with the medication, and preference for using it during future insertions were also recorded. The VAS scores were significantly different during IUD insertion among the 3 groups (p = .001). Pain scores in the tramadol group were significantly lower than in the naproxen group (p = .003), and the scores in the naproxen group was significantly lower than in the control group (p = .001). Patient satisfaction with the medication and preference for its future use were significantly lower in the control group than in the other 2 groups (p = .001). Prophylactic analgesia using 50 mg tramadol and 550 mg naproxen, delivered orally, can be used to relieve pain during IUD insertion. However, tramadol capsules were found to be more effective than naproxen tablets. Copyright © 2012 AAGL. Published by Elsevier Inc. All rights reserved.

Breaking Bad News to Patients with Cancer: A Randomized Control Trial of a Brief Communication Skills Training Module Incorporating the Stories and Preferences of Actual Patients

PubMed Central

Gorniewicz, James; Floyd, Michael; Krishnan, Koyamangalath; Bishop, Thomas W.; Tudiver, Fred; Lang, Forrest

2017-01-01

Objective This study tested the effectiveness of a brief, learner-centered, breaking bad news (BBN) communication skills training module using objective evaluation measures. Methods This randomized control study (N=66) compared intervention and control groups of students (n=28) and residents' (n=38) objective structured clinical examination (OSCE) performance of communication skills using Common Ground Assessment and Breaking Bad News measures. Results Follow-up performance scores of intervention group students improved significantly regarding BBN (colon cancer (CC), p=.007, r=-.47; breast cancer (BC), p=.003, r=-.53), attention to patient responses after BBN (CC, p < .001, r=-.74; BC, p=.001, r=-.65), and addressing feelings (BC, p=.006, r=-.48). At CC follow-up assessment, performance scores of intervention group residents improved significantly regarding BBN (p=.004, r=-.43), communication related to emotions (p=.034, r=-.30), determining patient's readiness to proceed after BBN and communication preferences (p=.041, r=-.28), active listening (p=011, r=-.37), addressing feelings (p<.001, r=-.65), and global interview performance (p=.001, r=-.51). Conclusion This brief BBN training module is an effective method of improving BBN communication skills among medical students and residents. Practice Implications Implementation of this brief individualized training module within health education programs could lead to improved communication skills and patient care. PMID:27876220

Comparison of the effects of vapocoolant spray and topical anesthetic cream on pain during needle electromyography in the medial gastrocnemius.

PubMed

Moon, Young-Eun; Kim, Sang-Hyun; Choi, Won-Hyeok

2013-05-01

To compare the effects of a vapocoolant spray and an eutectic mixture of local anesthetics (EMLA) cream in reducing pain during needle electromyography examination. Randomized controlled trial. Physical medicine and rehabilitation department of a university hospital. Adults who underwent needle electromyography (N=99) were randomized to 1 of 2 experimental groups or the control group. Two patients dropped out during the study. In the experimental groups, vapocoolant spray or EMLA cream were applied before needle electromyography. In the control group, needle electromyography was performed without pretreatment. Intensity of pain associated with needle electromyography was assessed using a 100-mm visual analog scale (VAS). Patient satisfaction and preference for repeated use were measured using a 5-point Likert scale. VAS score for pain intensity was significantly lower in the spray group (31.9; 95% confidence interval [CI], 22.0-41.7) compared with the control group (52.9; 95% CI, 45.9-60.0; P=.002), whereas there was no significant difference between the EMLA cream group (42.4; 95% CI, 34.2-50.7) and the control group. Patient satisfaction and preference for repeated use were higher in the spray group than the EMLA group. Vapocoolant spray was more effective than EMLA cream in reducing pain during needle electromyography. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Patient and family communication during consultation visits: The effects of a decision aid for treatment decision-making for localized prostate cancer.

PubMed

Song, Lixin; Tyler, Christina; Clayton, Margaret F; Rodgiriguez-Rassi, Eleanor; Hill, Latorya; Bai, Jinbing; Pruthi, Raj; Bailey, Donald E

2017-02-01

To analyze the effects of a decision aid on improving patients' and family members' information giving and question asking during consultations for prostate cancer treatment decision-making. This study is a secondary analysis of archived audio-recorded real-time consultation visits with participants from a randomized clinical trial. Participants were randomly assigned into three groups: TD-intervention targeted patient-only; TS-intervention targeted patients and family members; and control-a handout on staying healthy during treatment. We conducted content analysis using a researcher-developed communication coding system. Using SAS 9.3, we conducted Chi-square/Fisher's exact test to examine whether information giving and question asking among patients and family members varied by groups when discussing different content/topics. Compared with those in the TS and control groups, significantly higher percentages of participants in the TD group demonstrated information giving in discussing topics about diagnosis, treatment options, risks and benefits, and preferences; and engaged in question asking when discussing diagnosis, watchful waiting/active surveillance, risks and benefits, and preferences for treatment impacts. Information support and communication skills training for patients were effective in improving communication during treatment decision-making consultations. Providing information about prostate cancer and communication skills training empower patients and their family members. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Patient and family communication during consultation visits: The effects of a decision aid for treatment decision-making for localized prostate cancer

PubMed Central

Song, Lixin; Tyler, Christina; Clayton, Margaret F.; Rodgiriguez-Rassi, Eleanor; Hill, Latorya; Bai, Jinbing; Pruthi, Raj; Bailey, Donald E.

2016-01-01

Objective To analyze the effects of a decision aid on improving patients’ and family members’ information giving and question asking during consultations for prostate cancer treatment decision-making. Methods This study is a secondary analysis of archived audio-recorded real-time consultation visits with participants from a randomized clinical trial. Participants were randomly assigned into three groups: TD—intervention targeted patient-only; TS—intervention targeted patients and family members; and control—a handout on staying healthy during treatment. We conducted content analysis using a researcher-developed communication coding system. Using SAS 9.3, we conducted Chi-square/Fisher’s exact test to examine whether information giving and question asking among patients and family members varied by groups when discussing different content/topics. Results Compared with those in the TS and control groups, significantly higher percentages of participants in the TD group demonstrated information giving in discussing topics about diagnosis, treatment options, risks and benefits, and preferences; and engaged in question asking when discussing diagnosis, watchful waiting/active surveillance, risks and benefits, and preferences for treatment impacts. Conclusion Information support and communication skills training for patients were effective in improving communication during treatment decision-making consultations. Practice implications Providing information about prostate cancer and communication skills training empower patients and their family members. PMID:27692491

Reliable Refuge: Two Sky Island Scorpion Species Select Larger, Thermally Stable Retreat Sites.

PubMed

Becker, Jamie E; Brown, Christopher A

2016-01-01

Sky island scorpions shelter under rocks and other surface debris, but, as with other scorpions, it is unclear whether these species select retreat sites randomly. Furthermore, little is known about the thermal preferences of scorpions, and no research has been done to identify whether reproductive condition might influence retreat site selection. The objectives were to (1) identify physical or thermal characteristics for retreat sites occupied by two sky island scorpions (Vaejovis cashi Graham 2007 and V. electrum Hughes 2011) and those not occupied; (2) determine whether retreat site selection differs between the two study species; and (3) identify whether thermal selection differs between species and between gravid and non-gravid females of the same species. Within each scorpion's habitat, maximum dimensions of rocks along a transect line were measured and compared to occupied rocks to determine whether retreat site selection occurred randomly. Temperature loggers were placed under a subset of occupied and unoccupied rocks for 48 hours to compare the thermal characteristics of these rocks. Thermal gradient trials were conducted before parturition and after dispersal of young in order to identify whether gravidity influences thermal preference. Vaejovis cashi and V. electrum both selected larger retreat sites that had more stable thermal profiles. Neither species appeared to have thermal preferences influenced by reproductive condition. However, while thermal selection did not differ among non-gravid individuals, gravid V. electrum selected warmer temperatures than its gravid congener. Sky island scorpions appear to select large retreat sites to maintain thermal stability, although biotic factors (e.g., competition) could also be involved in this choice. Future studies should focus on identifying the various biotic or abiotic factors that could influence retreat site selection in scorpions, as well as determining whether reproductive condition affects thermal selection in other arachnids.

Drug specificity in drug versus food choice in male rats.

PubMed

Tunstall, Brendan J; Riley, Anthony L; Kearns, David N

2014-08-01

Although different classes of drug differ in their mechanisms of reinforcement and effects on behavior, little research has focused on differences in self-administration behaviors maintained by users of these drugs. Persistent drug choice despite available reinforcement alternatives has been proposed to model behavior relevant to addiction. The present study used a within-subjects procedure, where male rats (Long-Evans, N = 16) were given a choice between cocaine (1.0 mg/kg/infusion) and food (a single 45-mg grain pellet) or between heroin (0.02 mg/kg/infusion) and food in separate phases (drug order counterbalanced). All rats were initially trained to self-administer each drug, and the doses used were based on previous studies showing that small subsets of rats tend to prefer drug over food reinforcement. The goal of the present study was to determine whether rats that prefer cocaine would also prefer heroin. Choice sessions consisted of 2 forced-choice trials with each reinforcer, followed by 14 free-choice trials (all trials separated by 10-min intertrial interval). Replicating previous results, small subsets of rats preferred either cocaine (5 of the 16 rats) or heroin (2 of the 16 rats) to the food alternative. Although 1 of the 16 rats demonstrated a preference for both cocaine and heroin to the food alternative, there was no relationship between degree of cocaine and heroin preference in individual rats. The substance-specific pattern of drug preference observed suggests that at least in this animal model, the tendencies to prefer cocaine or heroin in preference to a nondrug alternative are distinct behavioral phenomena.