Challenges and recommendations for blinding in behavioral interventions illustrated using a case study of a behavioral intervention to lower blood pressure

Friedberg, Jennifer P.; Lipsitz, Stuart R.; Natarajan, Sundar

doi:10.1016/j.pec.2009.04.009

Cited by 56 publications

(73 citation statements)

References 46 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…This study was a single-blind trial: the participants did not know whether they were assigned to the intervention or control group; they were also blinded to the study hypothesis and details of the intervention and control group procedures, which minimized the possibility of differential reporting regarding the outcome variables. 34,35 Seasonal variations were shown to affect the level of indoor SHS exposure in earlier studies. 23 The current study conducted measurements in late spring and early autumn (with similar weather conditions) to adjust for seasonal fluctuations in indoor smoking behavior; therefore, we had to limit the follow-up period to 4 months.…”

Section: Figurementioning

confidence: 95%

Reducing Children’s Exposure to Secondhand Smoke at Home: A Randomized Trial

et al. 2013

View full text Add to dashboard Cite

WHAT'S KNOWN ON THIS SUBJECT:The World Health Organization estimates that ∼700 million children breathe tobacco smoke polluted air, particularly at home. Educational strategies either directly or indirectly targeting household decision-makers through other family members are effective in reducing children' s exposure in private homes. WHAT THIS STUDY ADDS:Intensive intervention was effective in decreasing children' s personal exposure to secondhand smoke (SHS), educating mothers about SHS, and promoting smoking restrictions at home. However, superiority over minimal intervention to decrease children' s personal exposure to SHS was not statistically significant. abstract OBJECTIVE: To develop and test an intervention to reduce children' s exposure to secondhand smoke (SHS) at homes in Yerevan, Armenia. METHODS:A single-blind, randomized trial in 250 households with 2-to 6-year-old children tested an intensive intervention (counseling sessions, distribution of tailored educational brochures, demonstration of home air pollution, and 2 follow-up counseling telephone calls) against minimal intervention (distribution of standard leaflets). At baseline and 4-month follow-up, researchers conducted biomonitoring (children' s hair) and surveys. The study used paired t tests, McNemar' s test, and linear and logistic regression analyses. RESULTS:After adjusting for baseline hair nicotine concentration, child's age and gender, the follow-up geometric mean (GM) of hair nicotine concentration in the intervention group was 17% lower than in the control group (P = .239). The GM of hair nicotine in the intervention group significantly decreased from 0.30 ng/mg to 0.23 ng/mg (P = .024), unlike in the control group. The follow-up survey revealed an increased proportion of households with smoking restrictions and decreased exposure of children to SHS in both groups. The adjusted odds of children's less-than-daily exposure to SHS at follow-up was 1.87 times higher in the intervention group than in the control group (P = .077). The GM of mothers' knowledge scores at follow-up was 10% higher in the intervention group than in the control group (P = .006). CONCLUSIONS:Intensive intervention is effective in decreasing children' s exposure to SHS through educating mothers and promoting smoking restrictions at home. However, superiority over minimal intervention to decrease children' s exposure was not statistically significant.

show abstract

Section: Figurementioning

confidence: 95%

Reducing Children’s Exposure to Secondhand Smoke at Home: A Randomized Trial

et al. 2013

View full text Add to dashboard Cite

show abstract

“…The terms unblinded, single-blinded, double-blinded, and triple-blinded have been used to describe a variety of design methodologies (Friedberg, Lipsitz, & Natarajan, 2010;Iber, Riley, & Murray, 1987;Meinert & Tonascia, 1986;Penson & Wei, 2006;Portney & Watkins, 2000). Unblinded studies are those in which all parties are aware of group assignment.…”

Section: Types Of Blindingmentioning

confidence: 99%

Recruitment, Retention, and Blinding in Clinical Trials

Page

Persch

2013

The American Journal of Occupational Therapy

106

View full text Add to dashboard Cite

The recruitment and retention of participants and the blinding of participants, health care providers, and data collectors present challenges for clinical trial investigators. This article reviews challenges and alternative strategies associated with these three important clinical trial activities. Common recruiting pitfalls, including low sample size, unfriendly study designs, suboptimal testing locations, and untimely recruitment are discussed together with strategies for overcoming these barriers. The use of active controls, technology-supported visit reminders, and up-front scheduling is recommended to prevent attrition and maximize retention of participants. Blinding is conceptualized as the process of concealing research design elements from key players in the research process. Strategies for blinding participants, health care providers, and data collectors are suggested.

show abstract

“…The randomized assignments were concealed and computer-generated randomization was performed by the research coordinator, who was neither involved in assessment nor counseling. 17 Participants knew that we were evaluating whether telephone interventions improve hypertension management, but they did not know which active telephone arm they were in. Counselors knew the treatment assignments, but did not know the BP and adherence outcomes.…”

mentioning

confidence: 99%

“…Research assistants were blinded to treatment assignment. 17 Random assignment was made by computer-generated randomization (using statistical analysis system) to each treatment group by permuted blocks of size 6 by the site. For all consecutive blocks of size 6 in a site, 2 subjects were in each of the 3 treatments.…”

mentioning

confidence: 99%

Effectiveness of a Tailored Behavioral Intervention to Improve Hypertension Control

et al. 2015

Self Cite

View full text Add to dashboard Cite

M ore than 65 million American adults have hypertension.1 Diet, exercise, and drugs are mainstays of hypertension management. 2 The efficacy of hypertension treatment in preventing cardiovascular events is established.2 Although the system and provider interventions have improved blood pressure (BP) control rates from the previous low rate (27% 3 ) to more respectable rates (51% 1 to 79% 4,5 ), the substantial proportion remains uncontrolled. However, we may have reached the maximum control achievable with nontailored interventions targeting clinics or hospitals with growing concerns that such interventions may lead to overtreatment and adverse outcomes. 4,6 To optimize hypertension control further, approaches to identify and target patients at risk, to whom appropriately tailored therapy can then be offered, are needed.Suboptimal adherence is a common, but modifiable, problem leading to inadequate hypertension control. Fewer than 10% of adults with hypertension adhere fully to diet recommendations, 7 ≈35% exercise regularly, 8 and only 50% to 60% are fully medication adherent.9 In-person counseling to improve adherence requires time and is labor-intensive and costly. Telephone counseling offers a promising alternate approach, 10 and such counseling can be delivered at a convenient time and setting. 11Telephone interventions have improved medication adherence, 12,13 physical activity, 14 and diet, 15 all key to lowering BP. It is not known, however, whether novel theory-based behavioral interventions can be delivered by telephone and whether they are effective in busy, clinical settings.We conducted a randomized controlled trial to evaluate the effectiveness of targeting patients with repeated uncontrolled hypertension with either a tailored or a nontailored intervention in improving hypertension control and systolic blood pressure (SBP). Methods Design, Setting, and ParticipantsThe study was a randomized controlled trial to evaluate whether a telephone-delivered, behavioral stage-matched intervention (SMI) or a nontailored health education intervention (HEI) would lead to better BP control than usual care (UC) in patients with uncontrolled BP.The study was approved by the institutional review board. All participants provided written informed consent. Procedures were See Editorial Commentary, pp 273-275Abstract-Blood pressure (BP) control rates are suboptimal. We evaluated the effectiveness of 2 behavioral interventions to improve BP control via a 3-arm, randomized controlled trial of 533 adults with repeated uncontrolled BP, despite antihypertensive drug treatment for ≥6 months. The interventions were a tailored stage-matched intervention (SMI) or a nontailored health education intervention (HEI) of 6 monthly calls targeting diet, exercise, and medication. Control was usual care (UC). There were no baseline group differences.

show abstract

Challenges and recommendations for blinding in behavioral interventions illustrated using a case study of a behavioral intervention to lower blood pressure

Cited by 56 publications

References 46 publications

Reducing Children’s Exposure to Secondhand Smoke at Home: A Randomized Trial

Reducing Children’s Exposure to Secondhand Smoke at Home: A Randomized Trial

Recruitment, Retention, and Blinding in Clinical Trials

Effectiveness of a Tailored Behavioral Intervention to Improve Hypertension Control

Contact Info

Product

Resources

About