Is Three a Crowd? The Influence of Companions on a Patient’s Decision to Transition to a Biosimilar

Abstract Background Involving patients in treatment decisions is commonplace in healthcare, and patients are frequently accompanied by a companion (support person). Companions are often actively involved in medical consultations, yet their impact on decisions to change medications is unknown. Purpose This study examines the influence of companions on a patient’s decision to transition from their bio-originator therapy to a biosimilar. Methods A parallel, two-arm randomized controlled trial was conducted with 79 patients taking a bio-originator for rheumatic diseases who regularly attend clinic with a companion. Patients were randomized to receive an explanation about a hypothetical transition to a biosimilar alone or with their companion. Patients reported willingness to transition, risk perceptions, difficulty understanding, social support, and completed the Decisional Conflict Scale and Satisfaction with Decision Scale. Results Companions did not influence decisions to transition to biosimilars or cognitive and affective risk perceptions. Accompanied patients reported more difficulty understanding the explanation (p = .006, Cohen’s d = .64) but thought it was more important to receive information with companions (p = .023, Cohen’s d = −.52). Companions did not impact decision satisfaction or decisional conflict. Receiving emotional, but not practical support, was associated with less decisional conflict in accompanied patients (p = .038, r 2 = 0.20). Conclusions The presence of companions does not seem to influence risk perceptions or decisions about transitioning to biosimilars. Companions, however, impact the patient’s reporting of their ability to understand treatment explanations. Providers should check understanding in all patients but may need to provide additional time or educational resources to accompanied patients and companions. Trial registration Australian New Zealand Clinical Trial Registry: ACTRN12619001435178.

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Zao Ren An Shen capsule for insomnia: A double-blind, randomized, placebo-controlled trial

SLEEP ◽

10.1093/sleep/zsab266 ◽

2021 ◽

Author(s):

Yoann Birling ◽

Xiaoshu Zhu ◽

Nicole Avard ◽

Caterina Tannous ◽

Paul P Fahey ◽

...

Keyword(s):

Herbal Medicine ◽

Adverse Events ◽

Chinese Herbal Medicine ◽

Controlled Trial ◽

Double Blind ◽

Subjective Sleep ◽

Chinese Herbal ◽

Cohen’S D ◽

Cohen's D ◽

Insomnia Severity

Abstract Study Objectives The aim of this study was to test the efficacy and safety of Zao Ren An Shen (ZRAS) capsule, a Chinese herbal medicine product, for the treatment of insomnia. Methods We conducted a double-blind randomized placebo-controlled trial. After a one-week placebo run-in, a total of 85 people with insomnia were randomly allocated to receive ZRAS or placebo for four weeks. The primary outcomes were insomnia severity assessed with the Insomnia Severity Index (ISI) and the number of participants with adverse events. Secondary outcomes included objective and subjective sleep parameters, psychological status, fatigue level, quality of life, acceptability, and tolerability. Results A non-significant (p > 0.05) difference of 0.7 points in ISI in favor of ZRAS capsule was found at the end of the treatment. The number of participants with adverse events was not significantly different (p > 0.05) between the two groups. Except for subjective sleep onset latency, which had a non-significant (p > 0.05) medium effect (Cohen’s d = 0.5), the effects in secondary efficacy outcomes were all small (Cohen’s d < 0.4) and non-significant (p > 0.05). The acceptability and tolerability were high in the active group. Conclusions ZRAS capsule is safe, acceptable, and tolerable, yet not more effective than placebo in the treatment of insomnia. As previous evidence showed that Chinese herbal medicine was effective for insomnia, these results may be explained by the dose of the product, which was lower than the dose generally used in the clinic.

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Efficacy of Oral Acetaminophen and Intravenous Chlorpheniramine Maleate versus Placebo to Prevent Red Cell Transfusion Reactions in Children and Adolescent with Thalassemia: A Prospective, Randomized, Double-Blind Controlled Trial

Anemia ◽

10.1155/2018/9492303 ◽

2018 ◽

Vol 2018 ◽

pp. 1-8 ◽

Cited By ~ 2

Author(s):

Piya Rujkijyanont ◽

Chalinee Monsereenusorn ◽

Pimpat Manoonphol ◽

Chanchai Traivaree

Keyword(s):

Blood Transfusion ◽

Controlled Trial ◽

Febrile Reaction ◽

Chlorpheniramine Maleate ◽

Clinical Trial Registry ◽

Double Blind ◽

Urticarial Rash ◽

To Receive ◽

Transfusion Reactions ◽

Rbc Transfusion

Background. Thalassemia is a common congenital hemolytic disorder. In severe cases, regular blood transfusion is essentially required. The role of premedications to prevent transfusion reactions is varied among institutions with no standard guideline. Objective. To prospectively compare the risk of transfusion reactions in thalassemia patients premedicated with acetaminophen and chlorpheniramine maleate (CPM) versus placebo prior to blood transfusion. Material and Method. A randomized, double-blinded, placebo-controlled transfusion reaction study of 147 eligible patients was analyzed. All administered red blood cell (RBC) products were leukoreduced blood products. Patients were monitored and followed for the development of transfusion reactions for 24 hours after RBC transfusion. Results. A total of 73 patients randomized to receive active drugs consisting of acetaminophen and CPM were compared to 74 patients receiving placebo. The overall incidences of febrile reaction and urticarial rash were 6.9% and 22% in the patients randomized to receive active drugs comparing with 9.5% and 35.2% in the patients receiving placebo with no significant differences between two groups. However, delayed development of urticarial rash at 4-24 hours after RBC transfusion was significantly higher in female and patients receiving placebo. Conclusion. Administration of premedications in thalassemia patients receiving RBC transfusion without a history of transfusion reactions does not decrease the overall risk of transfusion reactions. However, the use of CPM might be beneficial to prevent delayed urticarial rash in those patients especially in females (Thai Clinical Trial Registry (TCTR) study ID: 20140526001).

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Involving clinical experts in prioritising topics for health technology assessment: a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-016104 ◽

2017 ◽

Vol 7 (8) ◽

pp. e016104 ◽

Cited By ~ 1

Author(s):

Andrew Cook ◽

Elke Streit ◽

Gill Davage

Keyword(s):

Controlled Trial ◽

Free Text ◽

Intention To Treat ◽

Cohen’S D ◽

Registration Number ◽

Review Form ◽

Response Modes ◽

Randomised Controlled ◽

Scoring Tool ◽

Cohen's D

ObjectivesThe objective of this study was to explore whether reducing the material supplied to external experts during peer review and decreasing the burden of response would maintain review quality into prioritising research questions for a major research funder.Methods and analysisClinical experts who agreed to review documents outlining research for potential commissioning were screened for eligibility and randomised in a factorial design to two types of review materials (long document versus short document) and response modes (structured review form versus free text email response). Previous and current members of the funder’s programme groups were excluded. Response quality was assessed by use of a four-point scoring tool and analysed by intention to treat.Results554 consecutive experts were screened for eligibility and 460 were randomised (232 and 228 to long document or short document, respectively; 230 each to structured response or free text). 356 participants provided reviews, 90 did not respond and 14 were excluded after randomisation as not eligible.The pooled mean quality score was 2.4 (SD=0.95). The short document scored 0.037 (Cohen’s d=0.039) extra quality points over the long document arm, and the structured response scored 0.335 (Cohen’s d=0.353) over free text. The allocation did not appear to have any effect on the experts' willingness to engage with the task.ConclusionsNeither providing a short or a long document outlining suggested research was shown to be superior. However, providing a structured form to guide the expert response provided more useful information than allowing free text. The funder should continue to use a structured form to gather responses. It would be acceptable to provide shorter documents to reviewers, if there were reasons to do so.Trial registration numberANZCTR12614000167662.

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Understanding Language Features in Loneliness Forum Posts that Elicit Comments (Preprint)

10.2196/preprints.32756 ◽

2021 ◽

Author(s):

Anietie Andy

Keyword(s):

Language Processing ◽

Latent Dirichlet Allocation ◽

Well Being ◽

Time Of Day ◽

Online Forums ◽

Cohen’S D ◽

Increased Risk ◽

Social Media Platforms ◽

Cohen's D ◽

To Receive

BACKGROUND Loneliness is a threat to the well-being of individuals and in older adults is associated with increased risk of early mortality. Studies have shown that some individuals seek support around loneliness on online forums/social media platforms. A common challenge in online forums is that some posts do not receive comments. In some non-health related forums, posts not receiving comments may not be a serious concern, however, in an online health forum such as those focused on discussions around loneliness, posts not receiving comments could translate to individuals seeking support around loneliness not receiving adequate support. OBJECTIVE The aim of this work is to analyze posts published on an active online forum focused on discussions around loneliness (loneliness forum) to determine the language features associated with posts that elicit comments from members of the forum. METHODS For the analysis in this work, 15,012 posts published on an online loneliness forum by 9,956 users were analyzed. Of these posts, 6,450 received five or more comments, 13,221 received one or more comments, and 1,791 received no comments. Using the natural language processing method, latent dirichlet allocation (LDA) and a psycholinguistic dictionary, Linguistics Inquiry and Word Count (LIWC), the language features expressed in posts that elicit comments from members of the forum were determined. RESULTS The findings from this work show that posts related to topics themes on relationships (Cohen’s D = 0.319) and the use of negation words (Cohen’s D = 0.149) tend to receive one or more comments. Also, posts associated with LIWC categories on first person singular pronouns (Cohen’s D = 0.264) tend to elicit one or more comments. Posts on topic themes related to spending time around holidays/birthdays/year/time of day or week (Cohen’s D = 0.79) and affection relative to relationships (Cohen’s D = 0.102) tend to receive five or more comments. CONCLUSIONS This work identifies language features expressed in loneliness forum posts that elicit comments. The findings from this work can provide members of online loneliness forums tips on how to write posts that potentially elicit comments from members of the forum.

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Effect of Continues Midwifery Support in Labor on the Childbirth Experience and Self-Esteem of Primipara Women: A Randomized Controlled Trial

10.21203/rs.3.rs-833826/v1 ◽

2021 ◽

Author(s):

Nasrin Soleimani ◽

Mansoureh Refaei ◽

Farideh Kazemi

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Self Esteem ◽

Control Group ◽

Randomized Controlled ◽

Childbirth Experience ◽

Cohen’S D ◽

The Mean ◽

Cohen's D

Abstract Background: The World Health Organization states that mothers during labor and delivery should be supported by people with whom they feel comfortable, because one of the non-pharmacological methods of relieving labor pain is the continued support of midwives in labor. The primary objectives of this study were to determine the effect of continuous midwifery support in labor on delivery experience and self-esteem of nulliparous women 6 weeks after delivery.Methods: This randomized controlled trial was performed in 2021 on 70 pregnant women admitted to the delivery ward who met the inclusion criteria. Participants were randomly allocated to two groups through balanced block randomization with a block size of 4. Participants completed a demographic and midwifery information questionnaire before entering the study. In the intervention group, in addition to routine labor care, the researcher was present at the mother's bedside and was present with the mother continuously throughout the labor and up to 2 hours after delivery and provided the necessary support. The control group received only routine labor and postpartum care. Six weeks after delivery, participants in both groups were contacted to complete the CEQ and Rosenberg self-esteem questionnaires. Finally, data were collected and analyzed. Significance level was considered 0.05.Results: By controlling the effect of duration of the first and second stages of labor as potential confounders, the mean (sd) of childbirth experience 6 weeks after delivery was 70.92 (7.07) in the intervention group and 59.69 (7.08) in the control group, and this difference was statistically significant (p <0.001). The amount of effect size indicates a very strong effect of the intervention on improving the childbirth experience (Cohen’s d = 1.69; 95% CI: 1.12, 2.26). Comparison of the mean of maternal self-esteem showed that this rate in the intervention group was 2 scores higher than the control group and this difference was statistically significant (p = 0.05). Cohen's d indicates the average effect of intervention on mothers' self-esteem score (Cohen's d = 0.56; 95% CI: 0.06, 1.05).Conclusions: Continuous support of the midwife in labor and up to 2 hours after delivery can lead to a better childbirth experience and increase the mother's self-esteem up to 6 weeks after delivery.Trial registration: IRCT ID: IRCT20201102049233N1, First Registration date: 2021-06-04

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Effect of Long-Term Caloric Restriction on DNA Methylation Measures of Biological Aging in Healthy Adults: CALERIETM Trial Analysis

10.1101/2021.09.21.21263912 ◽

2021 ◽

Author(s):

reem waziry ◽

David L corcoran ◽

Kim M Huffman ◽

Michael S Kobor ◽

Meeraj Kothari ◽

...

Keyword(s):

Dna Methylation ◽

Controlled Trial ◽

Model Organisms ◽

Biological Aging ◽

Control Group ◽

Epigenetic Clock ◽

Long Term Effects ◽

Cohen’S D ◽

Cohen's D

Calorie restriction (CR) slows aging and increases healthy lifespan in model organisms. We tested if CR slowed biological aging in humans using DNA methylation analysis of blood samples from N=197 participants in the Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIETM) randomized controlled trial. We quantified CR effects on biological aging by comparing change scores for six epigenetic-clock and Pace-of-Aging measures between n=128 CR-group and n=69 ad-libitum-control-group participants at 12- and 24-month follow-ups. CR effects were strongest for DunedinPACE Pace of Aging (12-month Cohen's d=0.3; 24-month Cohen's d=0.2, p<0.01 for both), followed by DunedinPoAm and the GrimAge epigenetic clock, although effects for these measures were not statistically different from zero (p>0.08). CR effects for other epigenetic clocks were in the opposite direction (all p>0.15). CALERIE intervention slowed Pace of Aging but showed minimal effect on epigenetic clocks hypothesized to reflect longer term accumulation of aging burden.

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More insight into the concept of apathy: a multidisciplinary depression management program has different effects on depressive symptoms and apathy in nursing homes

International Psychogeriatrics ◽

10.1017/s1041610213001440 ◽

2013 ◽

Vol 25 (12) ◽

pp. 1941-1952 ◽

Cited By ~ 22

Author(s):

Ruslan Leontjevas ◽

Steven Teerenstra ◽

Martin Smalbrugge ◽

Myrra J.F.J. Vernooij-Dassen ◽

Ernst T. Bohlmeijer ◽

...

Keyword(s):

Depressive Symptoms ◽

Controlled Trial ◽

Multidisciplinary Treatment ◽

Depressive Mood ◽

Management Program ◽

Intention To Treat ◽

Mood Symptoms ◽

Cohen’S D ◽

Depression Management ◽

Cohen's D

ABSTRACTBackground:Apathy is common in nursing home (NH) residents and it overlaps with depression. This study examines the effects of a multidisciplinary depression program on apathy and depressive motivational and mood symptoms.Methods:Secondary analyses of a stepped-wedge cluster-randomized controlled trial were conducted with six measurements. Sixteen dementia NH units and 17 somatic units were enrolled. In the intervention condition, a program containing depression assessment procedures and multidisciplinary treatment (activating strategies, psychotherapy, and medication) was introduced. Usual care was provided in the control condition. Outcomes were assessed using the 10-item Apathy Evaluation Scale and the Cornell Scale for Depression in Dementia.Results:Intention-to-treat analyses showed that the whole depression management program reduced apathy in dementia units (p < 0.001; Cohen's d, −0.35), and depressive motivational symptoms in somatic units (p = 0.008; Cohen's d, −0.40). Depressive mood symptoms were not affected in both unit types. The effect on apathy in dementia units was mainly attributed to activating strategies (p < 0.001; Cohen's d, −0.73). The effect on motivational symptoms in somatic units was mainly attributed to psychotherapy (p = 0.002; Cohen's d, −0.80). Apathy worsening was associated with pharmacological depression treatment in both unit types (p = 0.009; Cohen's d, 0.35).Conclusions:Depression management may affect apathy and depressive symptoms differently, which underpins the position of apathy as a distinct syndrome. NH professionals can effectively use activating strategies in dementia units, and psychotherapy in somatic units. More research is needed on treating depressive mood symptoms, and on effects of antidepressants in NHs.

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Efficacy of maternal B12 supplementation in vegetarian women for improving infant neurodevelopment: protocol for the MATCOBIND multicentre, double-blind, randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-034987 ◽

2020 ◽

Vol 10 (5) ◽

pp. e034987

Author(s):

Jitender Nagpal ◽

Manu Raj Mathur ◽

Swapnil Rawat ◽

Deepti Nagrath ◽

Charlotte Lee ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Post Partum ◽

Controlled Trial ◽

Clinical Care ◽

First Trimester ◽

Clinical Trial Registry ◽

Double Blind ◽

Study Results ◽

Randomised Controlled ◽

To Receive

IntroductionVitamin B12 deficiency is widely prevalent across many low- and middle-income countries, especially where the diet is low in animal sources. While many observational studies show associations between B12 deficiency in pregnancy and infant cognitive function (including memory, language and motor skills), evidence from clinical trials is sparse and inconclusive.Methods and analysisThis double-blind, multicentre, randomised controlled trial will enrol 720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal). Eligible mothers who give written consent will be randomised to receive either 250 mcg methylcobalamin or 50 mcg (quasi control), from enrolment to 6 months post-partum, given as an oral daily capsule. All mothers and their infants will continue to receive standard clinical care. The primary trial outcome is the offspring’s neurodevelopment status at 9 months of age, assessed using the Development Assessment Scale of Indian Infants. Secondary outcomes include the infant’s biochemical B12 status at age 9 months and maternal biochemical B12 status in the first and third trimesters. Maternal biochemical B12 status will also be assessed in the first trimester. Modification of association by a priori identified factors will also be explored.Ethical considerations and disseminationThe study protocol has been approved by ethical committees at each study site (India and Nepal) and at University College London, UK. The study results will be disseminated to healthcare professionals and academics globally via conferences, presentations and publications. Researchers at each study site will share results with participants during their follow-up visits.Trial registration numberCTRI/2018/07/015048 (Clinical Trial Registry of India); NCT04083560 (ClinicalTrials.gov)

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92 Effects of Smartphone Coaching Intervention on Dietary Intake for Bariatric Surgery Candidates: A Pilot Randomized Controlled Trial

CNS Spectrums ◽

10.1017/s1092852919000683 ◽

2019 ◽

Vol 24 (1) ◽

pp. 220-221

Author(s):

Youngjung Kim ◽

Robyn Sysko ◽

Andreas Michaeledes ◽

Tatiana Ramos ◽

Tom Hildebrandt

Keyword(s):

Bariatric Surgery ◽

Controlled Trial ◽

Fat Intake ◽

Control Groups ◽

Randomized Controlled ◽

Cohen’S D ◽

End Of Treatment ◽

Surgery Outcomes ◽

Cohen's D ◽

Pilot Randomized Controlled Trial

AbstractIntroductionBariatric surgery outcomes are variable, often with suboptimal weight loss and/or weight relapse. Smartphone coaching applications offer a potential window of affecting behavioral change to improve outcomes in a widespread and cost-effective way, but clinical efficacy is unknown. In phase I of this pilot study, we investigated effects of pre-surgical treatment with a mobile coaching platform Noom Coach for Bariatric Health.MethodsForty adult candidates (82.5% female) for bariatric surgery were recruited for pilot randomized controlled trial (Noom Bariatric Health vs. Standard Care). All participants’ dietary intake was assessed initially and after 8weeks of intervention, with the 24-hour dietary recall (ASA24) to analyze food intake. Paired t-tests were used to compare within group changes in dietary parameters. Independent t-tests were used to assess inter-group differences at the end of treatment.ResultsPost intervention, both Noom and Control groups consumed numerically less total calories, empty calories, fat, and carbohydrates compared to their baseline. Reduction in empty calorie consumption was significant only in Noom (t=2.39, p=0.04, Cohen’s d=0.96) and not in Control (t=0.89, p=0.40, Cohen’s d=0.30). Both total kcal and total fat intake showed larger numerical reductions within Noom (kcal,fat: t=1.94,2.07; p=0.08,0.07; Cohen’s d=1.03,1.06) compared to reductions seen within Control (kcal,fat; t=0.41,0.48; p=0.69,0.64; Cohen’s d=0.14,0.16). There were no other significant changes in macronutrients and micronutrients within groups. At the end of treatment, Noom compared to Control groups had significantly lower percentage fat intake (t=3.02, p=0.008, Cohen’s d=1.42) without initial difference at screening (t=1.12, p=0.27, Cohen’s d=0.36).DiscussionThough limited due to small sample size, preliminary results appear promising that mobile coachingintervention may have beneficial effects on diet pre-bariatric surgery. We will discuss the impact of these findings on potential post-surgery outcomes.Funding Acknowledgements: NIH R44DK116370, Mount Sinai Hospital

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In-person vs. eHealth Mindfulness-based Intervention for Adolescents with Chronic Illnesses: A Pilot Randomized Trial

Adolescent Psychiatry ◽

10.2174/2210676608666181031102235 ◽

2019 ◽

Vol 9 (1) ◽

pp. 11-23 ◽

Cited By ~ 1

Author(s):

Nicholas Chadi ◽

Elli Weisbaum ◽

Catherine Malboeuf-Hurtubise ◽

Sara Ahola Kohut ◽

Christine Viner ◽

...

Keyword(s):

Mental Health ◽

Controlled Trial ◽

Well Being ◽

Chronic Illnesses ◽

Time Data ◽

Total N ◽

Mindfulness Skills ◽

Cohen’S D ◽

Group Frequency ◽

Cohen's D

Background: Mindfulness-Based Interventions (MBIs) can improve mental health and well-being in adolescents with chronic illnesses. However, there are many barriers such as reduced mobility and distance which compromise accessibility to MBIs. Objective: The aim of this study was to determine the effectiveness of the Mindful Awareness and Resilience Skills for Adolescents (MARS-A) program in youth with chronic illnesses delivered in person or via eHealth. Method: In this mixed method randomized controlled trial, participants received weekly 90- minute long MARS-A sessions for 8 weeks, either in person or via a secure eHealth audiovisual platform allowing group interactions in real time. Data was collected at baseline, immediately after and two months post-MBI through saliva analyses, electronic participant logs and validated questionnaires assessing mindfulness skills and mental health outcomes. Results: Seven participants per group completed the intervention (total n=14, completion rate 77.8%). Paired t-test analyses revealed a significant reduction in depression/anxiety scores immediately post-intervention (p=0.048, Cohen’s d=0.934) and a significant reduction in pre-post mindfulness cortisol levels at week 8 (p=0.022, Cohen’s d=0.534) in the eHealth group. Frequency and duration of weekly individual home practice (eHealth: 6.5 times; 28.8 minutes; in-person: 6.0 times; 30.6 minutes) were similar in both groups and maintained at follow-up. Conclusion: This is the first study comparing in-person and eHealth delivery of an 8-week MBI for adolescents with chronic illnesses. Although the study was limited by the small size of the sample, our results suggest that eHealth delivery of MBIs may represent a promising avenue for increasing availability in this population.

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