Control Groups

Objective: To evaluate the effects of an unsupervised multimodal online tai chi intervention on knee pain and function for people with knee osteoarthritis.

Design, setting, and participants: The RETREAT study was a 2-group superiority randomized clinical trial enrolling participants who met clinical criteria for knee osteoarthritis in Australian communities from August 2023 and November 2024.

Interventions: Participants in the control group received access to a purpose-built website containing information about osteoarthritis and exercise benefits. Participants in the intervention group received the My Joint Tai Chi intervention comprising access to the same website plus tai chi information, a 12-week unsupervised video-based Yang-style tai chi program, and encouragement to use an app to facilitate program adherence.

Main outcomes and measures: Changes in knee pain during walking (Numeric Rating Scale; range 0-10 with higher scores indicating greater pain) and difficulty with physical function (Western Ontario and McMaster Universities Osteoarthritis Index; range 0-68 with higher scores indicating greater dysfunction) during 12 weeks. Secondary outcomes included another knee pain measure, sport and recreation function, quality of life, physical and mental well-being, fear of movement, self-efficacy, balance confidence, positive activated affect, sleep quality, global improvement, and oral medication use.

Results: Of 2106 patients screened, 178 met inclusion criteria and were randomized, 89 (mean [SD] age, 61.0 [8.7] years; 66 female [74%] and 23 [26%] male participants) to the control group and 89 (mean [SD] age, 62.1 [7.3] years; 59 [66%] female and 30 male [34%] participants) to the tai chi intervention. Of the total, 170 (96%) completed both of the primary outcomes at 12 weeks. The tai chi group reported greater improvements in knee pain (control, -1.3; tai chi, -2.7; mean difference, -1.4 [95% CI, -2.1 to -0.7] units; P < .001) and function (control, -6.9; tai chi, -12.0; mean difference, -5.6 [95% CI, -9.0 to -2.3] units; P < .001) compared to the control group. More participants in the tai chi than in the control group achieved a minimal clinically important difference in pain (73% vs 47%; risk difference, 0.3; 95% CI, 0.1 to 0.4; P < .001) and function (72% vs 52%; risk difference, 0.2; 95% CI, 0.1 to 0.3; P = .007). Between-group differences for most secondary outcomes favored tai chi, including another knee pain measure, sport and recreation function, quality of life, physical and mental well-being, global improvement, pain self-efficacy, and balance confidence. No associated serious adverse events were reported.

Conclusions and relevance: This randomized clinical trial found that this unsupervised multimodal online tai chi intervention improved knee pain and function compared with the control at 12 weeks. This free-to-access web-based intervention offers an effective, safe, accessible, and scalable option for guideline-recommended osteoarthritis exercise.

Author/s:

Shiyi Julia Zhu, Rana S Hinman, Rachel K Nelligan, Peixuan Li, Anurika P De Silva, Jenny Harrison, Alexander J Kimp, Kim L Bennell

The effect of lead exposure on IQ test scores in children under 12 years: a systematic review and meta-analysis of case-control studies

Saige Blanchard — Tue, 14 Jun 2022 05:00:00 +0000

Date Added:

June 14, 2022

Journal/Publication:

Systematic Reviews

Publisher:

BioMed Central Ltd

Publication Date:

May 30, 2022

Issue:

Volume:

URL:

The effect of lead exposure on IQ test scores in children under 12 years: a systematic review and meta-analysis of case-control studies

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1186/s13643-022-01963-y

Keywords

PMID (1):

35637522

MeSH

Quantification of the impact of lead exposure in children on IQ scores. James W. Mold, MD, MPH

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An inevitable exposure to the toxic heavy metal such as lead in our environmental can have irreversible effects on children's mental performance.In this study, 3316 children in 8 case-control studies were selected for review. The case group was exposed to a concentration of lead above 10 μg/dL, and the control group was exposed to a concentration of less than 10 μg/dL, but the duration of exposure was different among studies, and the subgroup analysis was performed based on this variable.In the subgroup with duration of exposure less than the average of 4.5 years, the difference of IQ test score between two groups was significant (MD = -3.53) (P-value <0.05). Also, in the subgroup with more than 4.5 years of duration, the difference of IQ test score was significant (MD = -22.63) (P-value < 0.001).This study demonstrates that the concentration and duration of lead exposure have a large effect on mental function in children.

Author/s:

Heidari, S., Mostafaei, S., Razazian, N., Rajati, M., Saeedi, A., Rajati, F.

Malnutrition in hospitalized adults: A systematic review

Bethie Seay — Thu, 14 Oct 2021 05:00:00 +0000

Date Added:

October 14, 2021

Journal/Publication:

Agency for Healthcare Research and Quality

Publication Date:

October 13, 2021

Issue:

Volume:

Pages:

EHC035

Type:

Meta-analyses, Reviews, and Guidelines

DOI (1):

10.23970/AHRQEPCCER249

A summary of what we know about the impact and management of malnutrition in hospitalized patients.

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Objectives. To review the association between malnutrition and clinical outcomes among hospitalized patients, evaluate effectiveness of measurement tools for malnutrition on clinical outcomes, and assess effectiveness of hospital-initiated interventions for patients diagnosed with malnutrition.

Data sources. We searched electronic databases (Embase®, MEDLINE®, PubMed®, and the Cochrane Library) from January 1, 2000, to June 3, 2021. We hand-searched reference lists of relevant studies and searched for unpublished studies in ClinicalTrials.gov.

Review methods. Using predefined criteria and dual review, we selected (1) existing systematic reviews (SRs) to assess the association between malnutrition and clinical outcomes, (2) randomized and non-randomized studies to evaluate the effectiveness of malnutrition tools on clinical outcomes, and (3) randomized controlled trials (RCTs) to assess effectiveness of hospital-initiated treatments for malnutrition. Clinical outcomes of interest included mortality, length of stay, 30-day readmission, quality of life, functional status, activities of daily living, hospital acquired conditions, wound healing, and discharge disposition. When appropriate, we conducted meta-analysis to quantitatively summarize study findings; otherwise, data were narratively synthesized. When available, we used pooled estimates from existing SRs to determine the association between malnutrition and clinical outcomes, and assessed the strength of evidence.

Results. Six existing SRs (including 43 unique studies) provided evidence on the association between malnutrition and clinical outcomes. Low to moderate strength of evidence (SOE) showed an association between malnutrition and increased hospital mortality and prolonged hospital length of stay. This association was observed across patients hospitalized for an acute medical event requiring intensive care unit care, heart failure, and cirrhosis. Literature searches found no studies that met inclusion criteria and assessed effectiveness of measurement tools. The primary reason studies did not meet inclusion criteria is because they lacked an appropriate control group. Moderate SOE from 11 RCTs found that hospital-initiated malnutrition interventions likely reduce mortality compared with usual care among hospitalized patients diagnosed with malnutrition. Low SOE indicated that hospital-initiated malnutrition interventions may also improve quality of life compared to usual care.

Conclusions. Evidence shows an association between malnutrition and increased mortality and prolonged length of hospital stay among hospitalized patients identified as malnourished. However, the strength of this association varied depending on patient population and tool used to identify malnutrition. Evidence indicates malnutrition-focused hospital-initiated interventions likely reduce mortality and may improve quality of life compared to usual care among patients diagnosed with malnutrition. Research is needed to assess the clinical utility of measurement tools for malnutrition.

Author/s:

Uhl, S., Siddique, S. M., McKeever, L., Bloschichak, A., D'Anci, K., Leas, B., Mull, N. K, Tsou, A. Y.

Perioperative alcohol cessation intervention for postoperative complications

Brian Desmarais — Sat, 15 Aug 2020 19:59:34 +0000

Date Added:

August 15, 2020

Journal/Publication:

The Cochrane Database of Systematic Reviews

Publication Date:

November 8, 2018

Issue:

Volume:

URL:

Perioperative alcohol cessation intervention for postoperative complications

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1002/14651858.CD008343.pub3.

MeSH

Postoperative Complications

This Cochrane review suggests that efforts to help adults with a history of risky alcohol consumption to quit prior to and following surgery reduces surgical complications including mortality. That isn’t surprising, but we haven’t always paid as much attention to alcohol consumption as we have to smoking as a risk factor for surgical complications. James W. Mold, MD, MPH

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Background: Risky consumption of alcohol is a global problem. More than 3.3 million deaths annually are associated with risky use of alcohol, and global alcohol consumption continues to increase. People who have high alcohol consumption often require planned and emergency surgical procedures.Risky drinking is associated with increased postoperative complications such as infections, cardiopulmonary complications, and bleeding episodes. Alcohol causes disorders of the liver, pancreas, and nervous system. Stopping consumption of alcohol can normalize these organ systems to some degree and may reduce the occurrence of complications after surgery.This review was first published in 2012 and was updated in 2018.

Objectives: To assess the effects of perioperative alcohol cessation interventions on rates of postoperative complications and alcohol consumption.

Search methods: We searched the following databases up until 21 September 2018: Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; MEDLINE; Embase; CINAHL via EBSCOhost; and two trials registers. We scanned the reference lists and citations of included trials and any identified relevant systematic reviews for further references to additional trials. When necessary, we contacted trial authors to ask for additional information.

Selection criteria: We included all randomized controlled trials (RCTs) that evaluated the effects of perioperative alcohol cessation interventions on postoperative complications and alcohol consumption. We included participants with risky consumption of alcohol who were undergoing all types of elective or acute surgical procedures under general or regional anaesthesia or sedation, who were offered a perioperative alcohol cessation intervention or no intervention.We defined 'risky drinking' as alcohol consumption equivalent to more than 3 alcoholic units (AU)/d or 21 AU/week (with 1 AU containing 12 grams of ethanol) with or without symptoms of alcohol abuse or dependency. This corresponds to the amount of alcohol associated with increased postoperative complication rates in most clinical studies.

Data collection and analysis: We used guidance provided in the Cochrane Handbook for Systematic Reviews of Interventions. We presented main outcomes as dichotomous variables in a meta-analysis. When data were available, we conducted subgroup and sensitivity analyses to explore the risk of bias. Primary outcome measures were postoperative complications and in-hospital and 30-day mortality. Secondary outcomes were successful quitting at the end of the programme, postoperative alcohol use, and length of hospital stay. We assessed the quality of evidence using the GRADE approach.

Main results: We included in this updated review one new study (70 participants), resulting in a total of three RCTs (140 participants who drank 3 to 40 AU/d). All three studies were of moderate to good quality. All studies evaluated the effects of intensive alcohol cessation interventions, including pharmacological strategies for alcohol withdrawal symptoms, patient education, and relapse prophylaxis. We identified one ongoing study.Overall, 53 of the 122 participants from three studies who underwent surgery developed any type of postoperative complication that required treatment. Of 61 participants in the intervention groups, 20 had complications, compared with 33 of 61 participants in the control groups (risk ratio (RR) 0.62, 95% confidence interval (CI) 0.40 to 0.96). Results show differences between the three clinical studies regarding outcome measurement and intensity of the interventions. However, all alcohol cessation programmes were intensive and included pharmacological therapy. The overall quality of evidence for this outcome is moderate.In-hospital and 30-day postoperative mortality rates were low in the three studies. Researchers reported one death among 61 participants in the intervention groups, and three deaths among 61 participants in the control groups (RR 0.47, 95% CI 0.07 to 2.96). The quality of evidence for this outcome is low.Investigators describe more successful quitters at the end of the intervention programme than among controls. Forty-one out of 70 participants in the intervention groups successfully quit drinking compared with only five out of 70 participants in the control groups (RR 8.22, 95% CI 1.67 to 40.44). The quality of evidence for this outcome is moderate.All three studies reported postoperative alcohol consumption (grams of alcohol/week) at the end of the programme as median and range values; therefore it was not possible to estimate the mean and the standard deviation (SD). We performed no meta-analysis. All three studies reported length of stay, and none of these studies described a significant difference in length of stay. Data were insufficient for review authors to perform a meta-analysis. No studies reported on the prevalence of participants without risky drinking in the longer term.

Authors' conclusions: This systematic review assessed the efficacy of perioperative alcohol cessation interventions for postoperative complications and alcohol consumption. All three studies showed a significant reduction in the number of participants who quit drinking alcohol during the intervention period. Intensive alcohol cessation interventions offered for four to eight weeks to participants undergoing all types of surgical procedures to achieve complete alcohol cessation before surgery probably reduced the number of postoperative complications. Data were insufficient for review authors to assess their effects on postoperative mortality. No studies reported an effect on length of stay, and no studies addressed the prevalence of risky drinking in the longer term.Included studies were few and reported small sample sizes; therefore one should be careful about drawing firm conclusions based on these study results. All three studies were conducted in Denmark, and most participants were men. The included participants may represent a selective group, as they could have been more motivated and/or more interested in participating in clinical research or otherwise different, and effects may have been overestimated for both intervention and control groups in these studies. Trial results indicate that these studies are difficult to perform, that strong research competencies are necessary for future studies, and that further evaluation of perioperative alcohol cessation interventions in high-quality randomized controlled trials is needed. Once published and assessed, the one 'ongoing' study identified may alter the conclusions of this review.

Conflict of interest statement

Hanne Tønnesen has authored all three of the studies included in this review (Egholm 2017; Tønnesen 1999a; Tønnesen 2002).

Julie Weber Melchior Egholm, Johanna Adami, and Bolette Pedersen have authored one of the included studies (Egholm 2017).

Hanne Tønnesen is also the primary investigator for the ongoing study (NCT02188446).

Therefore, to avoid any potential bias, Carsten B Juhl extracted data and checked the interpretation against study reports and any available study registration details or protocols as an independent review author.

Author/s:

Egholm, Julie W., Pedersen, Bolette, Møller, Ann M., Adami, Johanna, Juhl, Carsten B., Tønnesen, Hanne

Effectiveness of a Mouth Care Program Provided by Nursing Home Staff vs Standard Care on Reducing Pneumonia Incidence: A Cluster Randomized Trial

Brian Desmarais — Mon, 22 Jun 2020 15:39:47 +0000

Date Added:

June 22, 2020

Journal/Publication:

JAMA Network Open

Publisher:

American Medical Association

Publication Date:

June 1, 2020

Issue:

Volume:

URL:

Effectiveness of a Mouth Care Program Provided by Nursing Home Staff vs Standard Care on Reducing Pneumonia Incidence: A Cluster Randomized Trial

Type:

Clinical Research Results

Format:

Article

DOI (1):

https://doi.org/10.1001/jamanetworkopen.2020.4321

Keywords

MeSH

The organisms responsible for pneumonia live in the mouth. Technically, nearly all pneumonias are due to aspiration. At least one RCT in Japan showed that excellent oral hygiene (by dental hygienists) in NHs can reduce the incidence of pneumonia. This study showed that enhanced oral hygiene performed by nurses reduced pneumonia episodes for the first year, and then the effect waned. James W. Mold, MD, MPH

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Abstract

Importance: Pneumonia affects more than 250 000 nursing home (NH) residents annually. A strategy to reduce pneumonia is to provide daily mouth care, especially to residents with dementia.

Objective: To evaluate the effectiveness of Mouth Care Without a Battle, a program that increases staff knowledge and attitudes regarding oral hygiene, changes mouth care, and improves oral hygiene, in reducing the incidence of pneumonia among NH residents.

Design, setting, and participants: This pragmatic cluster randomized trial observing 2152 NH residents for up to 2 years was conducted from September 2014 to May 2017. Data collectors were masked to study group. The study included 14 NHs from regions of North Carolina that evidenced proportionately high rehospitalization rates for pneumonia and long-term care residents. Nursing homes were pair matched and randomly assigned to intervention or control groups.

Intervention: Mouth Care Without a Battle is a standardized program that teaches that mouth care is health care, provides instruction on individualized techniques and products for mouth care, and trains caregivers to provide care to residents who are resistant and in special situations. The control condition was standard mouth care.

Main outcomes and measures: Pneumonia incidence (primary) and hospitalization and mortality (secondary), obtained from medical records.

Results: Overall, the study enrolled 2152 residents (mean [SD] age, 79.4 [12.4] years; 1281 [66.2%] women; 1180 [62.2%] white residents). Participants included 1219 residents (56.6%) in 7 intervention NHs and 933 residents (43.4%) in 7 control NHs. During the 2-year study period, the incidence rate of pneumonia per 1000 resident-days was 0.67 and 0.72 in the intervention and control NHs, respectively. Neither the primary (unadjusted) nor secondary (covariate-adjusted) analyses found a significant reduction in pneumonia due to Mouth Care Without a Battle during 2 years (unadjusted incidence rate ratio, 0.90; upper bound of 1-sided 95% CI, 1.24; P = .27; adjusted incidence rate ratio, 0.92; upper bound of 1-sided 95% CI, 1.27; P = .30). In the second year, the rate of pneumonia was nonsignificantly higher in intervention NHs. Adjusted post hoc analyses limited to the first year found a significant reduction in pneumonia incidence in intervention NHs (IRR, 0.69; upper bound of 1-sided 95% CI, 0.94; P = .03).

Conclusions and relevance: This matched-pairs cluster randomized trial of a mouth care program compared with standard care was not effective in reducing pneumonia incidence at 2 years, although reduction was found during the first year. The lack of significant results in the second year may be associated with sustainability. Improving mouth care in US NHs may require the presence and support of dedicated oral care aides.

Author/s:

Zimmerman, S., Sloane, P.D., Ward, K., Wretman, C.J., Stearns, S.C., Poole, P., Preisser, J.S.

Estimating Lifetime Benefits of Comprehensive Disease-Modifying Pharmacological Therapies in Patients With Heart Failure With Reduced Ejection Fraction: A Comparative Analysis of Three Randomised Controlled Trials

John Bayhi — Tue, 26 May 2020 20:29:33 +0000

Date Added:

May 26, 2020

Journal/Publication:

Lancet

Publisher:

Elsevier Ltd

Publication Date:

May 21, 2020

Volume:

Online ahead of print

URL:

Estimating Lifetime Benefits of Comprehensive Disease-Modifying Pharmacological Therapies in Patients With Heart Failure With Reduced Ejection Fraction: A Comparative Analysis of Three Randomised Controlled Trials

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1016/S0140-6736(20)30748-0

Keywords

CHF patients

heart failure

pharmacologic management

PMID (1):

32446323

MeSH

Humans

Angiotensin Receptor Antagonists

Mineralocorticoid Receptor Antagonists

Angiotensin-Converting Enzyme Inhibitors

Sodium-Glucose Transporter 2 Inhibitors

Peptidyl-Dipeptidase A

Neprilysin

heart failure

SLC5A2 protein, human

sodium-glucose transporter 2

Stroke Volume

Control Groups

Receptors, Drug

Progression-Free Survival

Receptors, Angiotensin

NR3C2 protein, human

For those of you who still initiate and manage CHF with reduced LV ejection fraction, this meta-analysis appears to support using combinations of the following five agents: 1) an ACEI or ARB, 2) a beta-blocker, 3) a mineralocorticoid receptor antagonist [MRA], 4) an angiotensin receptor–neprilysin inhibitor [ARNI], and 5) a sodium/glucose cotransporter 2 [SGLT2] inhibitor. They estimate that combined therapy could increase life expectancy for an 80-year-old 1.4 years and for a 55-year-old 6.3 years. If we are going to continue to manage these patients, it looks like we are going to have to develop specific CHF visits and protocols like those used in CHF clinics run by cardiology teams. James W. Mold, MD, MPH

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Background: Three drug classes (mineralocorticoid receptor antagonists [MRAs], angiotensin receptor-neprilysin inhibitors [ARNIs], and sodium/glucose cotransporter 2 [SGLT2] inhibitors) reduce mortality in patients with heart failure with reduced ejection fraction (HFrEF) beyond conventional therapy consisting of angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) and β blockers. Each class was previously studied with different background therapies and the expected treatment benefits with their combined use are not known. Here, we used data from three previously reported randomised controlled trials to estimate lifetime gains in event-free survival and overall survival with comprehensive therapy versus conventional therapy in patients with chronic HFrEF.

Methods: In this cross-trial analysis, we estimated treatment effects of comprehensive disease-modifying pharmacological therapy (ARNI, β blocker, MRA, and SGLT2 inhibitor) versus conventional therapy (ACE inhibitor or ARB and β blocker) in patients with chronic HFrEF by making indirect comparisons of three pivotal trials, EMPHASIS-HF (n=2737), PARADIGM-HF (n=8399), and DAPA-HF (n=4744). Our primary endpoint was a composite of cardiovascular death or first hospital admission for heart failure; we also assessed these endpoints individually and assessed all-cause mortality. Assuming these relative treatment effects are consistent over time, we then projected incremental long-term gains in event-free survival and overall survival with comprehensive disease-modifying therapy in the control group of the EMPHASIS-HF trial (ACE inhibitor or ARB and β blocker).

Findings: The hazard ratio (HR) for the imputed aggregate treatment effects of comprehensive disease-modifying therapy versus conventional therapy on the primary endpoint of cardiovascular death or hospital admission for heart failure was 0·38 (95% CI 0·30-0·47). HRs were also favourable for cardiovascular death alone (HR 0·50 [95% CI 0·37-0·67]), hospital admission for heart failure alone (0·32 [0·24-0·43]), and all-cause mortality (0·53 [0·40-0·70]). Treatment with comprehensive disease-modifying pharmacological therapy was estimated to afford 2·7 additional years (for an 80-year-old) to 8·3 additional years (for a 55-year-old) free from cardiovascular death or first hospital admission for heart failure and 1·4 additional years (for an 80-year-old) to 6·3 additional years (for a 55-year-old) of survival compared with conventional therapy.

Interpretation: Among patients with HFrEF, the anticipated aggregate treatment effects of early comprehensive disease-modifying pharmacological therapy are substantial and support the combination use of an ARNI, β blocker, MRA, and SGLT2 inhibitor as a new therapeutic standard.

Funding: None.

Author/s:

Vaduganathan, M., Claggett, BL, Jhund, PS, Cunningham, JW, Ferreira, JP, Zannad, F, Packer, M, Fonarow, GC, McMurray, JJV, Solomon, S.D.

5-year mental health and eating pattern outcomes following bariatric surgery in adolescents: a prospective cohort study

John Bayhi — Fri, 21 Feb 2020 19:36:07 +0000

Date Added:

February 21, 2020

Journal/Publication:

The Lancet Child and Adolescent Health

Publisher:

Elsevier Ltd.

Publication Date:

January 21, 2020

Issue:

Volume:

Pages:

P210-219

URL:

5-year mental health and eating pattern outcomes following bariatric surgery in adolescents: a prospective cohort study

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1016/S2352-4642(20)30024-9

Keywords

PMID (1):

31978372

Bariatric surgery in adolescents can improve BMI but not mental health, at least not in Sweden. James W. Mold, MD, MPH

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BACKGROUND:

Mental health problems are prevalent among adolescents with severe obesity, but long-term mental health outcomes after adolescent bariatric surgery are not well known. We aimed to assess mental health outcomes over 5 years of follow-up after Roux-en-Y gastric bypass surgery in adolescents who participated in the Adolescent Morbid Obesity Surgery (AMOS) study.

METHODS:

This was a non-randomised matched-control study in adolescents aged 13-18 years who had a BMI of 40 kg/m2 or higher, or 35 kg/m2 or higher in addition to obesity-related comorbidity; who had previously undergone failed comprehensive conservative treatment; and were of pubertal Tanner stage III or higher, with height growth velocity beyond peak. A contemporary control group, matched for BMI, age, and sex, who underwent conventional obesity treatment, was obtained from the Swedish Childhood Obesity Treatment Register. Data on dispensed psychiatric drugs and specialist treatment for mental disorders were retrieved from national registers with complete coverage. In the surgical group only, questionnaires were used to assess self-esteem (Rosenberg Self-Esteem [RSE] score), mood (Mood Adjective Checklist [MACL]), and eating patterns (Binge Eating Scale [BES] and Three-Factor Eating Questionnaire-R21 [TFEQ]). This study is registered with ClinicalTrials.gov (NCT00289705).

FINDINGS:

Between April 10, 2006, and May 20, 2009, 81 adolescents (53 [65%] female) underwent Roux-en-Y gastric bypass surgery, and 80 control participants received conventional treatment. The proportion of participants prescribed psychiatric drugs did not differ between groups in the years before study inclusion (pre-baseline; absolute risk difference 5% [95% CI -7 to 16], p=0·4263) or after intervention (10% [-6 to 24], p=0·2175). Treatment for mental and behavioural disorders did not differ between groups before baseline (2% [-10 to 14], p=0·7135); however, adolescents in the surgical group had more specialised psychiatric treatment in the 5 years after obesity treatment than did the control group (15% [1 to 28], p=0·0410). There were few patients who discontinued psychiatric treatment post-surgery (three [4%] receiving psychiatric drug treatment and six [7%] receiving specialised care for a mental disorder before surgery). In the surgical group, self-esteem (RSE score) was improved after 5 years (mixed model mean 21·6 [95% CI 19·9 to 23·4]) relative to baseline (18·9 [17·4 to 20·4], p=0·0059), but overall mood (MACL score) was not (2·8 [2·7 to 2·9] at 5 years vs 2·7 [2·6 to 2·8] at baseline, p=0·0737). Binge eating was improved at 5 years (9·3 [7·4 to 11·2]) relative to baseline (15·0 [13·5 to 16·5], p<0·0001). Relative changes in BMI were not associated with the presence or absence of binge eating at baseline.

INTERPRETATION:

Mental health problems persist in adolescents 5 years after bariatric surgery despite substantial weight loss. Although bariatric surgery can improve many aspects of health, alleviation of mental health problems should not be expected, and a multidisciplinary bariatric team should offer long-term mental health support after surgery.

FUNDING:

Swedish Research Council, VINNOVA, Västra Götalandsregionen, ALF VG-region, Region Stockholm, Swedish Child Diabetes Foundation, Swedish Heart and Lung Foundation, Tore Nilsson's Foundation, SUS Foundations and Donations, Capio Research Foundation, and Mary von Sydow's Foundation.

Author/s:

Järvholm, K, Bruze, G, Peltonen, M, Marcus, C, Flodmark, CE, Henfridsson, P, Beamish, AJ, Gronowitz, E, Dahlgren, J, Karlsson, J, Olbers, T

Alcohol Abstinence in Drinkers with Atrial Fibrillation

Brian Desmarais — Fri, 03 Jan 2020 22:27:35 +0000

Date Added:

January 3, 2020

Journal/Publication:

New England Journal of Medicine

Publication Date:

January 2, 2020

Issue:

Volume:

382

Pages:

20-28

URL:

Alcohol Abstinence in Drinkers with Atrial Fibrillation

Type:

Clinical Research Results

Format:

Article

DOI (1):

https://doi.org/10.1093/ntr/ntz234

Keywords

MeSH

Not surprisingly, reducing alcohol intake reduces the frequency of atrial fibrillation in patients known to have had episodes of atrial fibrillation.

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BACKGROUND:

Excessive alcohol consumption is associated with incident atrial fibrillation and adverse atrial remodeling; however, the effect of abstinence from alcohol on secondary prevention of atrial fibrillation is unclear.

METHODS:

We conducted a multicenter, prospective, open-label, randomized, controlled trial at six hospitals in Australia. Adults who consumed 10 or more standard drinks (with 1 standard drink containing approximately 12 g of pure alcohol) per week and who had paroxysmal or persistent atrial fibrillation in sinus rhythm at baseline were randomly assigned in a 1:1 ratio to either abstain from alcohol or continue their usual alcohol consumption. The two primary end points were freedom from recurrence of atrial fibrillation (after a 2-week "blanking period") and total atrial fibrillation burden (proportion of time in atrial fibrillation) during 6 months of follow-up.

RESULTS:

Of 140 patients who underwent randomization (85% men; mean [±SD] age, 62±9 years), 70 were assigned to the abstinence group and 70 to the control group. Patients in the abstinence group reduced their alcohol intake from 16.8±7.7 to 2.1±3.7 standard drinks per week (a reduction of 87.5%), and patients in the control group reduced their alcohol intake from 16.4±6.9 to 13.2±6.5 drinks per week (a reduction of 19.5%). After a 2-week blanking period, atrial fibrillation recurred in 37 of 70 patients (53%) in the abstinence group and in 51 of 70 patients (73%) in the control group. The abstinence group had a longer period before recurrence of atrial fibrillation than the control group (hazard ratio, 0.55; 95% confidence interval, 0.36 to 0.84; P = 0.005). The atrial fibrillation burden over 6 months of follow-up was significantly lower in the abstinence group than in the control group (median percentage of time in atrial fibrillation, 0.5% [interquartile range, 0.0 to 3.0] vs. 1.2% [interquartile range, 0.0 to 10.3]; P = 0.01).

CONCLUSIONS:

Abstinence from alcohol reduced arrhythmia recurrences in regular drinkers with atrial fibrillation. (Funded by the Government of Victoria Operational Infrastructure Support Program and others; Australian New Zealand Clinical Trials Registry number, ACTRN12616000256471.).

Author/s:

Voskoboinik, A., Kalman, J.M., De Silva, A., Nicholls, T., Costello, B., Nanayakkara, S., Prabhu, S., Stub, D., Azzopardi, S., Vizi, D., Wong, G., Nalliah, C., Sugumar, H., Wong, M., Kotschet, E., Kaye D., Taylor, A.J., Kistler, P.M.

Association between vitamin D supplementation and mortality: systematic review and meta-analysis

Brian Desmarais — Mon, 30 Sep 2019 13:33:28 +0000

Date Added:

September 30, 2019

Journal/Publication:

BMJ

Publication Date:

August 12, 2019

URL:

Association between vitamin D supplementation and mortality: systematic review and meta-analysis

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1136/bmj.l4673

Keywords

cancer

cancer mortality

vitamin D

Vitamin D3 supplimentation

MeSH

cardiovascular diseases

Outcome Assessment (Health Care)

Vitamin D3 supplementation appears to reduce cancer-related mortality. It is a little hard to tell whether it works regardless of initial 25OH VitD levels as this analysis suggests. James W. Mold, MD, MPH

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Abstract

OBJECTIVE:

To investigate whether vitamin D supplementation is associated with lower mortality in adults.

DESIGN:

Systematic review and meta-analysis of randomised controlled trials.

DATA SOURCES:

Medline, Embase, and the Cochrane Central Register from their inception to 26 December 2018.

ELIGIBILITY CRITERIA FOR SELECTING STUDIES:

Randomised controlled trials comparing vitamin D supplementation with a placebo or no treatment for mortality were included. Independent data extraction was conducted and study quality assessed. A meta-analysis was carried out by using fixed effects and random effects models to calculate risk ratio of death in the group receiving vitamin D supplementation and the control group.

MAIN OUTCOME MEASURES:

All cause mortality.

RESULTS:

52 trials with a total of 75 454 participants were identified. Vitamin D supplementation was not associated with all cause mortality (risk ratio 0.98, 95% confidence interval 0.95 to 1.02, I2=0%), cardiovascular mortality (0.98, 0.88 to 1.08, 0%), or non-cancer, non-cardiovascular mortality (1.05, 0.93 to 1.18, 0%). Vitamin D supplementation statistically significantly reduced the risk of cancer death (0.84, 0.74 to 0.95, 0%). In subgroup analyses, all cause mortality was significantly lower in trials with vitamin D3 supplementation than in trials with vitamin D2 supplementation (P for interaction=0.04); neither vitamin D3 nor vitamin D2 was associated with a statistically significant reduction in all cause mortality.

CONCLUSIONS:

Vitamin D supplementation alone was not associated with all cause mortality in adults compared with placebo or no treatment. Vitamin D supplementation reduced the risk of cancer death by 16%. Additional large clinical studies are needed to determine whether vitamin D3 supplementation is associated with lower all cause mortality.

STUDY REGISTRATION:

PROSPERO registration number CRD42018117823.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Author/s:

Zhang, Y., Fang, F., Tang, J., Jia, L., Feng, Y., Xu, P., Faramand, A.

Effectiveness of Behaviorally Designed Gamification Interventions With Social Incentives for Increasing Physical Activity Among Overweight and Obese Adults Across the United States: The STEP UP Randomized Clinical Trial

Brian Desmarais — Wed, 11 Sep 2019 19:46:36 +0000

Date Added:

September 11, 2019

Journal/Publication:

JAMA Internal Medicine

Publisher:

JAMA

Publication Date:

September 9, 2019

URL:

Effectiveness of Behaviorally Designed Gamification Interventions With Social Incentives for Increasing Physical Activity Among Overweight and Obese Adults Across the United States: The STEP UP Randomized Clinical Trial

Type:

Practice Management Reviews and Guidelines

DOI (1):

10.1001/jamainternmed.2019.3505.

Keywords

weigh loss programs

competition

MeSH

Wearable Electronic Devices

Economics, Behavioral

Goals

motivation

body mass index

Adding competition to a weight loss program enhanced and sustained its effectiveness. James W. Mold, MD, MPH

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IMPORTANCE:

Gamification, the use of game design elements in nongame contexts, is increasingly being used in workplace wellness programs and digital health applications. However, the best way to design social incentives in gamification interventions has not been well examined.

OBJECTIVE:

To assess the effectiveness of support, collaboration, and competition within a behaviorally designed gamification intervention to increase physical activity among overweight and obese adults.

DESIGN, SETTING, AND PARTICIPANTS:

This 36-week randomized clinical trial with a 24-week intervention and 12-week follow-up assessed 602 adults from 40 states with body mass indexes (calculated as weight in kilograms divided by height in meters squared) of 25 or higher from February 12, 2018, to March 17, 2019.

INTERVENTIONS:

Participants used a wearable device to track daily steps, established a baseline, selected a step goal increase, were randomly assigned to a control (n = 151) or to 1 of 3 gamification interventions (support [n = 151], collaboration [n = 150], and competition [n = 150]), and were remotely monitored. The control group received feedback from the wearable device but no other interventions for 36 weeks. The gamification arms were entered into a 24-week game designed using insights from behavioral economics with points and levels for achieving step goals. No gamification interventions occurred during follow-up.

MAIN OUTCOMES AND MEASURES:

The primary outcome was change in mean daily steps from baseline through the 24-week intervention period.

RESULTS:

A total of 602 participants (mean [SD] age, 39 [10] years; mean [SD] body mass index, 30 [5]; 427 [70.9%] male) were included in the study. Compared with controls, participants had a significantly greater increase in mean daily steps from baseline during the intervention in the competition arm (adjusted difference, 920; 95% CI, 513-1328; P < .001), support arm (adjusted difference, 689; 95% CI, 267-977; P < .001), and collaboration arm (adjusted difference, 637; 95% CI, 258-1017; P = .001). During follow-up, physical activity remained significantly greater in the competition arm than in the control arm (adjusted difference, 569; 95% CI, 142-996; P = .009) but was not significantly greater in the support (adjusted difference, 428; 95% CI, 19-837; P = .04) and collaboration (adjusted difference, 126; 95% CI, -248 to 468; P = .49) arms than in the control arm.

CONCLUSIONS AND RELEVANCE:

All 3 gamification interventions significantly increased physical activity during the 24-week intervention, and competition was the most effective. Physical activity was lower in all arms during follow-up and only remained significantly greater in the competition arm than in the control arm.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier: NCT03311230.

Author/s:

Patel, M.S., Small, D.S., Harrison, J.D., Fortunato, M.P., Oon, A.L., Rareshide, C.A.L., Reh, G., Szwartz, G., Guszcza, J., Steier, D., Kalra, P., Hilbert V.