Risk of bias in randomised controlled trials of health behaviour change interventions: Evidence, practices and challenges

Bruin, Marijn de

doi:10.1080/08870446.2014.960653

Cited by 21 publications

(26 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…There is also a pressing need to adapt existing ‘risk of bias’ and ‘quality of evidence’ assessment tools for behavioral interventions 44, 45, 46. For example, alternative strategies to minimize performance bias (such as preventing participant and provider awareness of primary research hypotheses) could be developed by trial researchers and then used by systematic reviewers in risk of bias assessments when blinding participants and providers is not an option 28.…”

Section: Suggestions Moving Forwardmentioning

confidence: 99%

“…Challenges may also arise when comparing a behavioral intervention to pharmacological interventions—although only when a placebo control is offered, as participants and providers would be aware of the presence of a pill in assigned intervention conditions 48. Cochrane is well positioned to take a leading role in developing and enforcing evidence‐based guidance on assessing risk of bias and quality of evidence tailored to behavioral interventions 44.…”

Section: Suggestions Moving Forwardmentioning

confidence: 99%

See 1 more Smart Citation

Reviewing and interpreting the effects of brief alcohol interventions: comment on a Cochrane review about motivational interviewing for young adults

et al. 2015

View full text Add to dashboard Cite

BackgroundCochrane recently published a systematic review on motivational interviewing (MI) for alcohol misuse in young adults. The review authors concluded that ‘there are no substantive, meaningful benefits of MI interventions for the prevention of alcohol misuse’ (p. 2), as effect sizes were ‘small and unlikely to be of any meaningful benefit in practice’ (p. 27). As most of these interventions were quite brief, we wish to open a dialogue about interpreting effect sizes in this review and of (brief) alcohol interventions more generally.AnalysisWe analyze four methodological aspects of the review that likely influenced the author's conclusions about intervention effects: (1) risk of bias assessments, (2) search strategies, (3) assessing the quality of the body of evidence and (4) definitions of sustainability and clinical significance.ConclusionsWe interpret the effect sizes found in this review to indicate modest yet beneficial and potentially meaningful effects of these interventions, given their brevity and low cost. This interpretation is consistent with other reviews on brief, MI‐based interventions and brief interventions more generally. We therefore encourage the field to re‐open dialogue about the clinical importance of the effects of MI on alcohol misuse by young adults. Rather than dismissing interventions with small effects, we believe a more fruitful way forward for the field would be to catalogue effect sizes for various alcohol interventions. Such a catalogue would help stakeholders themselves to choose which interventions meet their minimum desired impact, and thus may be suitable given their targeted populations, setting and resources.

show abstract

Section: Suggestions Moving Forwardmentioning

confidence: 99%

Section: Suggestions Moving Forwardmentioning

confidence: 99%

Reviewing and interpreting the effects of brief alcohol interventions: comment on a Cochrane review about motivational interviewing for young adults

et al. 2015

View full text Add to dashboard Cite

show abstract

“…The burden of disease from hepatitis C virus (HCV) in the United States remains high, with estimates of approximately three million infected people and peak rates predicted for the 2020s–2030s [ 1 ]. The development of novel HCV direct acting antivirals (DAAs)—which improve the tolerability and convenience of HCV treatment [ 2 , 3 ]—is changing the HCV treatment landscape [ 4 ]. Individuals who could not tolerate HCV treatment in the past are successfully undergoing treatment with new DAAs to achieve sustained virologic response (SVR) [ 3 ].…”

Section: Introductionmentioning

confidence: 99%

“…People who inject drugs (PWID) comprise approximately 60–70 % of new HCV infections in the US [ 1 ] and are particularly vulnerable to HCV infection for various reasons, including needle sharing and high-risk sexual behavior [ 6 – 8 ]. PWID have historically faced structural, systematic, clinical, and individual-level barriers to engaging in and completing HCV treatment [ 9 – 12 ], and much research has investigated factors that impede this group from undergoing HCV treatment [ 4 , 13 , 14 ]. Some inhibiting factors include social stigmatization, negative encounters with the medical field, provider reluctance to prescribe HCV-medications to PWID, lack of availability of effective new DAAs, and structural barriers such as lack of stable housing, fear of legal action, and lack of insurance [ 4 , 12 – 17 ].…”

Section: Introductionmentioning

confidence: 99%

The common sense model applied to hepatitis C: a qualitative analysis of the impact of disease comparison and witnessed death on hepatitis C illness perception

et al. 2015

View full text Add to dashboard Cite

BackgroundHepatitis C virus (HCV) accounts for 15,000 deaths in the United States yearly because people living with HCV are not identified in time to seek treatment, are ineligible for or refuse treatment, or face structural impediments to obtaining treatment such as lack of access to health care or lack of insurance. People who inject drugs (PWID) comprise a large proportion—estimates of up to 60–70 %—of current and new HCV infected individuals and face many barriers to completing HCV treatment.MethodsWe conducted 30 qualitative semi-structured interviews of current and former PWID seeking HCV treatment at an opioid-agonist treatment facility in New York City. We used thematic analysis, informed by grounded theory, to examine perceptions of HCV and decisions to initiate HCV treatment. We analyzed the themes that emerged via the common sense model (CSM) of illness perception theoretical framework.ResultsUsing thematic analyses, two major themes emerged related to engagement in HCV treatment. First, participants independently compared HCV to HIV, and in so doing, emphasized the potential fatality of HCV and the need for treatment. Second, participants described witnessing others suffer or die from untreated HCV and expressed how these recollections impacted their desire to undergo treatment themselves. Together, these themes contributed to the way participants perceived HCV and informed their decisions to initiate treatment. Both themes reflect the CSM’s “self-regulation” process, which posits that understanding the causes and consequences of an illness impacts one’s ability to seek treatment to overcome this illness state.ConclusionsThis paper offers insight into how clinicians can better understand and utilize HCV illness perceptions to evaluate willingness to engage in HCV treatment among PWID considering antiviral treatment modalities.

show abstract

“…Another limitation is that not all included studies clearly reported blinding, ITT, or allocation concealment. Improving reporting of RCTs by following the CONSORT statement [43] and implementing strategies to reduce the risk of bias [44] would further facilitate evaluation of HIV prevention research. Similarly, improving reporting of serostatus of partners can provide better data for assessing seroadaptive strategies practiced by PLWH and determining the level of risk that sexual behaviors pose for HIV transmission.…”

Section: Resultsmentioning

confidence: 99%

Effects of integrated interventions on transmission risk and care continuum outcomes in persons living with HIV

Crepaz

Baack

Higa

et al. 2015

Aids

View full text Add to dashboard Cite

Background Reducing HIV infection and improving outcomes along the continuum of HIV care are high priorities of the U.S. National HIV/AIDS Strategy. Interventions that target multiple problem behaviors simultaneously in an integrated approach (referred to as integrated interventions) may improve prevention and care outcomes of persons living with HIV (PLWH). This systematic review and meta-analysis examines the effects of integrated interventions. Methods A systematic review, including both electronic and hand searches, was conducted to identify randomized controlled trials (RCTs) published between 1996 and 2014 that were designed to target at least two of the following behaviors among PLWH: HIV transmission risk behaviors, HIV care engagement, and medication adherence. Effect sizes (ESs) were meta-analyzed using random-effects models. Results Fifteen RCTs met the inclusion criteria. Integrated interventions significantly reduced sex without condoms (odds ratio [OR] = 0.74, 95% CI = 0.59, 0.94, p = .013, 13 ESs) and had marginally significant effects on improving medication adherence behaviors (OR = 1.35, 95% CI = 0.98, 1.85, p = .063, 12 ESs) and undetectable viral load (OR = 1.46, 95% CI= 0.93, 2.27, p = .098, 7 ESs). Significant intervention effects on at least two outcomes were seen in RCTs tailored to individual needs, delivered one-on-one, or in settings where PLWH received services or care. Conclusions Integrated interventions produced some favorable prevention and care continuum outcomes in PLWH. How to incorporate integrated interventions with other Combination HIV Prevention strategies to reach the optimal impact requires further research.

show abstract

Risk of bias in randomised controlled trials of health behaviour change interventions: Evidence, practices and challenges

Cited by 21 publications

References 23 publications

Reviewing and interpreting the effects of brief alcohol interventions: comment on a Cochrane review about motivational interviewing for young adults

Reviewing and interpreting the effects of brief alcohol interventions: comment on a Cochrane review about motivational interviewing for young adults

The common sense model applied to hepatitis C: a qualitative analysis of the impact of disease comparison and witnessed death on hepatitis C illness perception

Effects of integrated interventions on transmission risk and care continuum outcomes in persons living with HIV

Contact Info

Product

Resources

About