Chapter 8 Flashcards

The 2015 guidance focuses on conducting process evaluations of complex interventions. Nevertheless, it fails to offer a definition of acceptability or specific materials for operationalising it. Without a shared understanding of what acceptability refers to it is unclear how intervention developers are to assess acceptability for those receiving and delivering healthcare interventions. In contrast, group trials allocate the intervention to groups of subjects. A well-known type of group trial is a community trial, in which the intervention is allocated therapy to entire communities or neighborhoods. In the 1940s the effectiveness of fluoride in preventing dental caries was tested comparing the frequency of caries in the children in Kingston and Newburgh.

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In the United Kingdom, the Research Council has published three guidance documents for researchers and research funders in relation to appropriate methods for designing and evaluating complex interventions [10–12]. The number of references to acceptability has increased with each guidance publication which reflects the growing importance of this construct. The 2000 MRC guidance document makes no reference to acceptability, whereas the 2015 guidance refers to acceptability 14 times but lacks a definition and fails to provide clear instructions on how to assess acceptability. When thinking about the potential benefit of competing treatment options, one has to consider both the effectiveness of therapy and its cost. An interesting way to think about this is to calculate the number of people you would need to treat in order to prevent one adverse outcome.

11.3 Undertaking subgroup analyses

Measures used to assess acceptability focused on behaviour (e.g. dropout rates) , affect (i.e. feelings) , cognition (i.e. perceptions) or a combination of these . Based on the results of your analysis, what recommendations would you make regarding the benefits and risks of this regimen with low dose aspirin? Write down your recommendations, based on your analysis of this data, regarding the use of low dose aspirin. In a study published online last week in the online journal PLoS One, researchers explained to 80 volunteers with irritable bowel syndrome that half of them would receive routine treatment and the other half would receive a placebo. Explain why it is important to maintain high rates of follow-up in a prospective cohort study or a clinical trial. New potential drugs need to pass through three phases of interventional testing to show that they are safe and effective before receiving approval from the U.S.

In a trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants’ behavior, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other.

12.2 General principles for dealing with missing data

Bring a friend or make friends trekking and make a difference in 2023 by fundraising to help us support the nation’s mental health. Even though bone fractures are common injuries, they’re still scary to experience. If you break a bone, talk to your provider or surgeon about what to expect.

  • Talk to your provider about a bone density test if you’re older than 50 or if you have a family history of osteoporosis.
  • If the occurrence of an event is very low, even in a very large trial, there may not be sufficient events to detect differences in outcomes between treatment and control groups.
  • This working definition of acceptability can be operationalised for the purpose of measurement.
  • You have a volatile situation in which you have an unhealthy family system sitting in the same room with the substance user, who often feels it is everyone else in the room’s fault for their current situation.
  • Steps included defining acceptability; describing its properties and scope and identifying component constructs and empirical indicators.
  • It is advisable to perform analyses both with and without outlying studies as part of a sensitivity analysis (see Section 10.14).

On average there is little difference between the odds ratio and risk ratio in terms of consistency . When the study aims to reduce the incidence of an adverse event, there is empirical evidence that risk ratios of the adverse event are more consistent than risk ratios of the non-event . Selecting an effect measure based on what is the most consistent in a particular situation is not a generally recommended strategy, since it may lead to a selection that spuriously maximizes the precision of a meta-analysis estimate. Where they involve a regulated product, such as a drug or vaccine, they are usually post-registration or post-licensure studies. Safety issues that are important, but which arise in a relatively small proportion of individuals, may only become apparent through Phase IV studies, once there is widespread use of an intervention. Phase IV studies sometimes take the form of randomized trials where the safety and effectiveness are assessed by comparing the results of administering the product to some individuals or communities, but not to others . However, such trials may be difficult to conduct, once a product has been licensed by the national regulatory authority, and then non-randomized assessments must be made, such as through ‘before versus after studies’ or case-control investigations.

8 Meta-analysis of counts and rates

The participants would be those who were willing to participate (i.e., consented after being fully informed about the study) and also met eligibility criteria that take into account scientific and safety considerations. For example, an inclusion criterion might be age 45 or older in order to achieve a study sample that would produce a sufficient number of end points. A mother’s health and well-being during pregnancy and around the time of delivery, including access to appropriate care, are critical determinants of maternal mortality and neonatal and child health in the early years of life, and possibly for much longer. The term “intervention” can be confusing because it can be used to refer to the various therapeutic approaches used to treat addiction, many of which are evidence-based and effective. These include motivational interviewing, cognitive behavioral therapy, and couples therapy. These evidence-based treatmentsand several others, typically take time and commitment on the part of the person with the addiction but are generally helpful. Social workers are frequently faced with efficiency questions related to the interventions we deliver—thus, cost-related evaluation is part of our professional accountability responsibilities.

Variability in the intervention effects being evaluated in the different studies is known as statistical heterogeneity, and is a consequence of clinical or methodological diversity, or both, among the studies. Statistical heterogeneity manifests itself in the observed intervention effects being more different from each other than one would expect due to random error alone. We will follow convention and refer to statistical heterogeneity simply as heterogeneity. In the following we consider the choice of statistical method for meta-analyses of odds ratios. Appropriate choices appear to depend on the comparator group risk, the likely size of the treatment effect and consideration of balance in the numbers of experimental and comparator participants in the constituent studies. We are not aware of research that has evaluated risk ratio measures directly, but their performance is likely to be very similar to corresponding odds ratio measurements.

Intention-to-Treat Analysis:

Many judgements are required in the process of preparing a meta-analysis. Sensitivity analyses should be used to examine whether overall findings are robust to potentially influential decisions. Meta-analysis is the statistical combination of results from two or more separate studies.

  • “The Johnson Institute intervention entails five therapy sessions that prepare the client and his or her family members for a family confrontation meeting.”
  • Factors such as participants’ attitudes towards the intervention, appropriateness, suitability, convenience and perceived effectiveness of the intervention have been considered as indicators of treatment acceptability.
  • If you suspect any injury to your spleen, seek medical attention right away to check it for bleeding.
  • However, the result of the meta-analysis can be interpreted without making such an assumption .

Whether requiring specific diagnosis or not, therapeutic or preventive agents are usually taken on an individual basis, though sometimes agents can be distributed to everyone in a community through the water supply or in food . Mass treatment of school-age children in areas highly endemic for the infection with an anti-schistosomal drug every year or two may be sufficient to virtually eliminate serious disease consequences of infection with Schistosoma mansoni. A cross-sectional study involves data collection at just one point in time.

What to Look for in an Interventionist

Of course, the use of statistical synthesis methods does not guarantee that the results of a review are valid, any more than it does for a primary study. Many studies are too small to provide convincing evidence about intervention effects in isolation. A review in which specified and appropriate methods have been used to identify, appraise, and summarise studies addressing a defined question. The proportional reduction in risk between experimental and control participants in a trial. The probability that an observed or greater difference occurred by chance if it is assumed that there is, in fact, no real difference between the effects of the interventions. If this probability is less than 1/20 (which is when the P value is less than 0.05), then the result is conventionally regarded as being “statistically significant”.

Make sure each team member has the same information about your loved one’s addiction and the intervention so that everyone is on the same page. Hold meetings or conference calls to share updates and agree to present a united team. Research your loved one’s addiction or substance abuse issue so that you have a good understanding of it. If the program requires travel, make arrangements ahead of time — consider having a packed suitcase ready for your loved one.

Key items to look for in the study’s reporting of results

Box 2.1 is reproduced from the guidelines and summarizes the steps in developing and evaluating trials involving complex interventions. Often, children, partners, siblings and parents are subjected to abuse, violence, threats and emotional upheaval because of alcohol and drug problems. You don’t have control over the behavior of your loved one with the addiction. However, you do have the ability to remove yourself — and any children — from a destructive situation.

sensitivity analyses


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