Explaining all without causing unnecessary harm : is there scope for positively framing medical risk information?

Clinicians in the United Kingdom are now legally obliged to tell patients about every risk involved in prescribed medical treatments. Although important for informed consent, warning patients of risks such as side-effects can increase the incidence of these very side-effects, through the nocebo effect. Positively framing risk information could be a potential solution to this dilemma, and preliminary data has shown it is effective in healthy volunteers receiving a sham drug. Future research is needed to test its effectiveness in a clinical population

Medicine-related beliefs predict attribution of symptoms to a sham medicine : a prospective study

Objectives To investigate a range of possible predictors of nocebo responses to medicines. Design Prospective cohort study. Methods In total, 203 healthy adult volunteers completed measures concerning demographics, psychological factors, medicine‐related beliefs, baseline symptoms, and symptom expectations before taking a sham pill, described as ‘a well‐known tablet available without prescription’ that was known to be associated with several side effects. Associations between these measures and subsequent attribution of symptoms to the tablet were assessed using a hurdle model consisting of a joint logistic and truncated negative binomial regression. Results Men had an increased odds of attributing symptoms to the tablet OR = 1.52, and older participants had decreased odds, OR = 0.97. Medicine‐related beliefs were important, with modern health worries, belief that medicines cause harm and perceived sensitivity to medicines associated with increased odds of symptom attribution, OR = 1.02, 1.10, 1.09, respectively. Trust in medicines and pharmaceutical companies decreased the odds of symptom attribution, OR = 0.91, 0.88, respectively. The number of symptoms at baseline and the expected likelihood of symptoms were associated with an increased odds of attributing symptoms to the tablet, OR = 1.07, 1.06, respectively. Anxiety, previous symptom experience, symptom expectations, and modern health worries were also important in predicting the number of symptoms participants attributed to the tablet. Conclusion It is hard to predict who is at risk of developing nocebo responses to medicines from demographic or personality characteristics. Context‐specific factors such as beliefs about and trust in medicines, current symptoms and symptom expectations are more useful as predictors. More work is needed to investigate this in a patient sample

A systematic review of factors that contribute to nocebo effects.

Objectives: Medication side effects are common, often leading to reduced quality of life, nonadherence, and financial costs for health services. Many side effects are the result of a psychologically mediated “nocebo effect.” This review identifies the risk factors involved in the development of nocebo effects. Method: Web of Science, Scopus, MEDLINE, PsycINFO, Journals@Ovid full text, and Global Health were searched using the terms “nocebo” and “placebo effect.” To be included, studies must have exposed people to an inert substance and have assessed 1 or more baseline or experimental factor(s) on its ability to predict symptom development in response to the inert exposure. Results: Eighty-nine studies were included; 70 used an experimental design and 19 used a prospective design, identifying 14 different categories of risk factor. The strongest predictors of nocebo effects were a higher perceived dose of exposure, explicit suggestions that the exposure triggers arousal or symptoms, observing people experiencing symptoms from the exposure, and higher expectations of symptoms. Conclusions: To reduce nocebo induced symptoms associated with medication or other interventions clinicians could reduce expectations of symptoms, limit suggestions of symptoms, correct unrealistic dose perceptions, and reduce exposure to people experiencing side effects. There is some evidence that we should do this especially for persons with at-risk personality types, though exactly which personality types these are requires further research. These suggestions have a downside in terms of consent and paternalism, but there is scope to develop innovative ways to reduce nocebo effects without withholding information

A systematic review of infectious illness presenteeism : prevalence, reasons and risk factors

Background Workplace presenteeism is common and leads to the spread of infectious diseases. Previous reviews have focused on presenteeism in relation to general physical or mental ill health. In this systematic review we identified the prevalence of, and reasons and risk factors for, presenteeism in relation to an infectious illness. Method We searched Medline, Scopus, Web of Science, PsycINFO and PsycARTICLES with terms relating to infectious illnesses and presenteeism at the work place or school; reference lists of relevant articles were also hand-searched. Result Our search yielded 3580 papers after deduplication. After title, abstract and full text screening, 23 papers reporting on 24 studies were included. Twenty-three studies were cross-sectional studies and one was prospective. The quality of included studies was relatively poor due to problems such as sampling and non-response bias. Presenteeism prevalence ranged from 35 to 97%. Self-reported reasons for presenteeism fell into three main themes: 1. Organisational factors (organisational policy, presenteeism culture, disciplinary action), 2. Job characteristics (lack of cover, professionalism, job demand), and 3. Personal reasons (burden on colleagues, colleague perceptions, threshold of sickness absence and financial concerns). Statistical risk factors fell into four themes: 1. Sociodemographic, 2. Health, 3. Influenza-related behaviour, and 4. Employment characteristics. Most of the risk factors had insufficient evidence to allow us to draw any firm conclusions, and evidence regarding gender and age was inconsistent. The risk factor with the most consistent findings concerned occupation type, suggesting that those who worked in the healthcare sector, and specifically physicians, were at a higher risk of infectious illness presenteeism. Conclusion Infectious illness presenteeism is common. To address the public health consequences, organisations should focus on promoting a positive working culture and developing sickness absence policies that reduce presenteeism. Further research is needed in non-health sector organisations and schools to identify risk factors related to different organisations, which can then be used to tailor interventions at the organisational and individual level

The impact of unplanned school closure on children’s social contact : rapid evidence review

Background Emergency school closures are often used as public health interventions during infectious disease outbreaks to minimise the spread of infection. However, if children continue mixing with others outside the home during closures, the effect of these measures may be limited. Aim This review aimed to summarise existing literature on children’s activities and contacts made outside the home during unplanned school closures. Methods In February 2020, we searched four databases, MEDLINE, PsycInfo, Embase and Web of Science, from inception to 5 February 2020 for papers published in English or Italian in peer-reviewed journals reporting on primary research exploring children’s social activities during unplanned school closures. Main findings were extracted. Results A total of 3,343 citations were screened and 19 included in the review. Activities and social contacts appeared to decrease during closures, but contact remained common. All studies reported children leaving the home or being cared for by non-household members. There was some evidence that older child age (two studies) and parental disagreement (two studies) with closure were predictive of children leaving the home, and mixed evidence regarding the relationship between infection status and such. Parental agreement with closure was generally high, but some disagreed because of perceived low risk of infection and issues regarding childcare and financial impact. Conclusion Evidence suggests that many children continue to leave home and mix with others during school closures despite public health recommendations to avoid social contact. This review of behaviour during unplanned school closures could be used to improve infectious disease modelling

Initiator Types and the Causal Question of the Prevalent New-User Design: A Simulation Study

New-user designs restricting to treatment initiators have become the preferred design for studying drug comparative safety and effectiveness using nonexperimental data. This design reduces confounding by indication and healthy-adherer bias at the cost of smaller study sizes and reduced external validity, particularly when assessing a newly approved treatment compared with standard treatment. The prevalent new-user design includes adopters of a new treatment who switched from or previously used standard treatment (i.e., the comparator), expanding study sample size and potentially broadening the study population for inference. Previous work has suggested the use of time-conditional propensity-score matching to mitigate prevalent user bias. In this study, we describe 3 "types"of initiators of a treatment: new users, direct switchers, and delayed switchers. Using these initiator types, we articulate the causal questions answered by the prevalent new-user design and compare them with those answered by the new-user design. We then show, using simulation, how conditioning on time since initiating the comparator (rather than full treatment history) can still result in a biased estimate of the treatment effect. When implemented properly, the prevalent new-user design estimates new and important causal effects distinct from the new-user design

The effect of nocebo explanation and empathy on side-effect expectations of medication use following a fictional GP consultation

The simple act of informing patients about side-effects increases the likelihood they will experience them (i.e. the nocebo effect). Explaining this psychological phenomenon could help to reduce side-effect experience, however, it is yet to be explored if this can be applied to clinical settings where new medication is prescribed. In addition, the degree to which a health-care provider empathetically communicates this to patients may have an impact. To investigate this, we carried out 2 × 2 factorial trial to assess the effect of nocebo explanation and empathy (plus their interaction) on side-effect expectations following a fictional GP consultation prescribing a new medication. Overall, 208 participants were randomised to watch one of the four fictive GP consultations and play the role of the patient. In all videos, participants received information about the reason for the consultation, the recommendation of a new fictive medicine, how to take it, benefits and side-effects. The videos differed in whether the GP provided an explanation of the nocebo effect (yes/no) and whether they communicated in an empathetic style (yes/no). After watching the video, participants were asked about their side-effect expectations and rated the quality of the GP’s communication. Two-way ANOVAs revealed no main effect of nocebo explanation on expectation of side-effects warned or not warned about in the consultation. However, there was a main effect of empathy, with participants watching the empathetic consultations having significantly lower expectations of non-warned-about side-effects. There was no significant interaction. Findings suggest that explaining the nocebo effect and GP empathy did little to allay expectations of side-effects that were specifically mentioned in the consultation. However, GP empathy had an effect by helping to reduce additional side-effect expectations participants still had. Future work should extend these findings to real GP consultations where the full dimensions of empathy can be explored

Nondifferential Treatment Misclassification Biases Toward the Null? Not a Safe Bet for Active Comparator Studies

Active comparator studies are increasingly common, particularly in pharmacoepidemiology. In such studies, the parameter of interest is a contrast (difference or ratio) in the outcome risks between the treatment of interest and the selected active comparator. While it may appear treatment is dichotomous, treatment is actually polytomous as there are at least 3 levels: no treatment, the treatment of interest, and the active comparator. Because misclassification may occur between any of these groups, independent nondifferential treatment misclassification may not be toward the null (as expected with a dichotomous treatment). In this work, we describe bias from independent nondifferential treatment misclassification in active comparator studies with a focus on misclassification that occurs between each active treatment and no treatment. We derive equations for bias in the estimated outcome risks, risk difference, and risk ratio, and we provide bias correction equations that produce unbiased estimates, in expectation. Using data obtained from US insurance claims data, we present a hypothetical comparative safety study of antibiotic treatment to illustrate factors that influence bias and provide an example probabilistic bias analysis using our derived bias correction equations

A qualitative study about how families coped with managing their well-being, children’s physical activity and education during the COVID-19 school closures in England

In 2020, schools in England closed for six months due to COVID-19, resulting in children being home-schooled. There is limited understanding about the impacts of this on children’s mental and physical health and their education. Therefore, we explored how families coped with managing these issues during the school closures. We conducted 30 qualitative interviews with parents of children aged 18 years and under (who would usually be in school) between 16 and 21 April 2020. We identified three themes and eight sub-themes that impacted how families coped whilst schools were closed. We found that family dynamics, circumstances, and resources (Theme 1), changes in entertainment activities and physical movement (Theme 2) and worries about the COVID-19 pandemic (Theme 3) impacted how well families were able to cope. A key barrier to coping was struggles with home-schooling (e.g., lack of resources and support from the school). However, parents being more involved in their children’s personal development and education were considered a benefit to home-schooling. Managing the lack of entertainment activities and in-person interactions, and additional health worries about loved ones catching COVID-19 were challenges for families. Parents reported adverse behaviour changes in their children, although overall, they reported they were coping well. However, pre-existing social and educational inequalities are at risk of exacerbation. Families with more resources (e.g., parental supervision, access to green space, technology to facilitate home-schooling and no special educational needs) were better able to cope when schools were closed. On balance, however, families appeared to be able to adapt to the schools being closed. We suggest that policy should focus on supporting families to mitigate the widening health and educational gap between families with more and less resources

How to improve adherence with quarantine : rapid review of the evidence

Objectives The December 2019 outbreak of coronavirus has once again thrown the vexed issue of quarantine into the spotlight, with many countries asking their citizens to ‘self-isolate’ if they have potentially come into contact with the infection. However, adhering to quarantine is difficult. Decisions on how to apply quarantine should be based on the best available evidence to increase the likelihood of people adhering to protocols. We conducted a rapid review to identify factors associated with adherence to quarantine during infectious disease outbreaks. Study design The study design is a rapid evidence review. Methods We searched Medline, PsycINFO and Web of Science for published literature on the reasons for and factors associated with adherence to quarantine during an infectious disease outbreak. Results We found 3163 articles and included 14 in the review. Adherence to quarantine ranged from as little as 0 up to 92.8%. The main factors which influenced or were associated with adherence decisions were the knowledge people had about the disease and quarantine procedure, social norms, perceived benefits of quarantine and perceived risk of the disease, as well as practical issues such as running out of supplies or the financial consequences of being out of work. Conclusions People vary in their adherence to quarantine during infectious disease outbreaks. To improve this, public health officials should provide a timely, clear rationale for quarantine and information about protocols; emphasise social norms to encourage this altruistic behaviour; increase the perceived benefit that engaging in quarantine will have on public health; and ensure that sufficient supplies of food, medication and other essentials are provided