Why do children attend school, engage in other activities or socialise when they have symptoms of an infectious illness? A cross-sectional survey.

OBJECTIVES: To prevent the spread of infectious disease, children are typically asked not to attend school, clubs or other activities, or socialise with others while they have specific symptoms. Despite this, many children continue to participate in these activities while symptomatic. DESIGN AND SETTING: We commissioned a national cross-sectional survey with data collected between 19 November and 18 December 2021. PARTICIPANTS: Eligible parents (n=941) were between 18 and 75 years of age, lived in the UK and had at least one child aged between 4 and 17 years. Parents were recruited from a pre-existing pool of potential respondents who had already expressed an interest in receiving market research surveys. OUTCOME MEASURES: Parents were asked whether their children had exhibited either recent vomiting, diarrhoea, high temperature/fever, a new continuous cough, a loss or change to their sense of taste or smell in the absence of a negative (PCR) COVID-19 test ('stay-at-home symptoms') since September 2021 and whether they attended school, engaged in other activities outside the home or socialised with members of another household while symptomatic ('non-adherent'). We also measured parent's demographics and attitudes about illness. RESULTS: One-third (33%, n=84/251, 95% CI: 28% to 39%) of children were 'non-adherent' in that they had attended activities outside the home or socialised when they had stay-at-home symptoms. Children were significantly more likely to be non-adherent when parents were aged 45 and younger; they allowed their children to make their own decisions about school attendance; they agreed that their child should go to school if they took over-the-counter medication; or they believed that children should go to school if they have mild symptoms of illness. CONCLUSION: To reduce the risk of spreading disease, parents and teenagers need guidance to help them make informed decisions about engaging in activities and socialising with others while unwell.

Parent-reported child's close contact with non-household family members and their well-being during the COVID-19 pandemic: A cross-sectional survey.

In England (UK), at the start of the COVID-19 pandemic the public were required to reduce their physical contacts to slow the spread of COVID-19. We investigated the factors associated with children having: 1) close contact with family members from outside their household ('non-adherent behaviour'); and 2) low well-being (Revised Child Anxiety and Depression Scale). We conducted an online cross-sectional survey, completed at any location of the participant's choice between 8 and 11 June 2020 in parents (n = 2,010) who were aged eighteen years or over and had a school-aged child (4-18 years old). Parents reported that 15% (n = 309) of children had non-adherent contact and that 26% (n = 519) had low well-being. We used a series of binary logistic regressions to investigate associations between outcomes and child and parent characteristics. Children had higher odds of having non-household contact when they had special educational needs [adjusted odds ratio, 2.19 (95% CI, 1.47 to 3.27)], lower well-being [2.65 (95% CI, 2.03 to 3.46)], were vulnerable to COVID-19 [2.17 (95% CI, 1.45 to 3.25)], lived with someone who was over 70 years old [2.56 (95% CI, 1.55 to 4.24)] and their parent had low well-being [1.94 (95% CI, 1.45 to 2.58)]. Children had higher odds of lower well-being when they had special educational needs [4.13 (95% CI, 2.90 to 5.87)], were vulnerable to COVID-19 [3.06 (95% CI, 2.15 to 4.36)], lived with someone else who was vulnerable to COVID-19 [2.08 (95% CI, 1.64 to 2.64)], or lived with someone who was over 70 years old [2.41 (95% CI, 1.51 to 3.83)]. Many children came into contact with non-household family members, mainly for childcare. Factors relating to COVID-19, children's well-being and education were also important. If school closures are needed in future, addressing these issues may help reduce contact.

Risk factors for school-based presenteeism in children: a systematic review.

INTRODUCTION: Children attending school whilst unwell, known as school-based presenteeism, results in negative impacts on education and mental and physical health. We aimed to identify the risk factors for this behaviour. METHOD: We conducted a systematic search of five databases (11 July 2022) using words associated with school (e.g., school and childcare) and presenteeism (e.g., presenteeism and sick leave). The studies are synthesised according to the risk factors associated with school-based presenteeism and are grouped into themes by related topics. RESULTS: Our review included 18 studies, with quantitative, qualitative, and mixed-method study designs. Children, parents, and school staff reported past incidents and intentions for future presenteeism. We identified five themes from these reports: perceptions about the illness / signs and symptom(s); children's characteristics; children's and parents' motivations and attitudes towards school; organisational factors; and school sickness policy. Increased risk of school-based presenteeism was commonly linked to symptoms that were perceived low in severity and unidentifiable, children with a high school absence record, disbelief in children's illness, unsupportive employers, vague school policies and financial consequences. CONCLUSIONS: School-based presenteeism is complex due to the competing interests of the multiple individuals involved, such as children, parents, and school staff. Sickness policies need to include clear and specific guidance about illness and the signs and symptoms of diseases and should be communicated to all relevant individuals to mitigate against discrepancies in how the policy is interpreted. Furthermore, parents and school staff need support, such as financial and childcare, to be able to manage children when they are unwell.

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.

A Qualitative Study Evaluating the Factors Affecting Families' Adherence to the First COVID-19 Lockdown in England Using the COM-B Model and TDF.

The ability of families to adhere to public health guidance is critical to controlling a pandemic. We conducted qualitative interviews with 30 parents of children aged 18 and under, between 16 and 21 April 2020 when schools in England were closed due to the COVID-19 pandemic. Using the Theoretical Domains Framework, we classified the factors that influenced adherence to seven non-pharmaceutical interventions. We found 40 factors that influenced a family's ability to adhere. Parents generally indicated they could adhere and reported how their family had changed their behaviour to comply with the guidance. Parents primarily reported they were motivated to adhere out of concern for the health consequences of COVID-19, and because the guidance was delivered by the government. However, we found that reduced access to resources (e.g., technology, transport, and outside space) and social influences that encouraged non-adherent behaviour, decreased adherence. Furthermore, we suggest that families with low psychological and physical ability may face additional challenges to adherence and need to be supported. During future school closures, public health agencies should account for these factors when developing guidance.

What influences whether parents recognise COVID-19 symptoms, request a test and self-isolate: A qualitative study.

BACKGROUND: Using test, trace and isolate systems can help reduce the spread of COVID-19. Parents have the additional responsibility of using these systems for themselves and acting on behalf of their children to help control COVID-19. We explored factors associated with the use of England's NHS Test and Trace service among parents of school-aged children. METHODS: One-to-one telephone interviews with parents (n = 18) of school-aged (4 to 18 years) children living in England between 30 November to 11 December 2020. Data were explored using thematic analysis. RESULTS: Three themes and eight sub-themes emerged. In terms of recognising symptoms of COVID-19, parents needed prompting before recalling the main symptoms described by the NHS. Parents suggested several factors relating to the nature of the symptom(s) and contextual information that might lead to or prevent them from seeking a test. Although parents supported symptomatic testing and described trusting official sources of information (e.g., Government and NHS websites). However, some concerns were raised regarding the accuracy of test results, safety at testing centres and logistics of testing but none of the concerns appeared to prevent engagement with testing. Parents perceived adherence to testing and self-isolation as pro-social behaviour, although family resources and circumstances impacted their ability to adhere fully. CONCLUSIONS: Our study identified several barriers to parents using NHS Test and Trace as needed. Information about the eligibility of testing (main symptoms of COVID-19 and the age of eligibility) needs to be more precise and resources provided to enable families to adhere to self-isolation if the efficiency of test, trace and isolate systems is to be optimised.

Why did some parents not send their children back to school following school closures during the COVID-19 pandemic: a cross-sectional survey.

Background: On 23 March 2020, schools closed to most children in England in response to COVID-19 until September 2020. Schools were kept open to children of key workers and vulnerable children on a voluntary basis. Starting 1 June 2020, children in reception (4-5 years old), year 1 (5-6 years old) and year 6 (10-11 years old) also became eligible to attend school. Methods: 1373 parents or guardians of children eligible to attend school completed a cross-sectional survey between 8 and 11 June 2020. We investigated factors associated with whether children attended school or not. Results: 46% (n=370/803) of children in year groups eligible to attend school and 13% (n=72/570) of children of key workers had attended school in the past 7 days. The most common reasons for sending children to school were that the child's education would benefit, the child wanted to go to school and the parent needed to work. A child was significantly more likely to attend if the parent believed the child had already had COVID-19, they had special educational needs or a person in the household had COVID-19 symptoms. Conclusions: Following any future school closure, helping parents to feel comfortable returning their child to school will require policy makers and school leaders to communicate about the adequacy of their policies to: (A) ensure that the risk to children in school is minimised; (B) ensure that the educational potential within schools is maximised; and (C) ensure that the benefits of school for the psychological well-being of children are prioritised.

Predicting Expectations of Side-Effects for Those Which Are Warned Versus Not Warned About in Patient Information Leaflets.

BACKGROUND: Research investigating predictors of side-effect expectations is disparate and largely based on hypothetical vignettes. PURPOSE: To carry out a secondary analysis of a randomized controlled trial and investigate the predictors of side-effect expectations for side-effects that were, or were not, warned about. METHODS: Two hundred and three healthy adults completed measures concerning demographics, psychological factors, baseline symptoms, and medication-related beliefs before reading one of two types of patient information leaflet (PIL) (standard or positively framed PIL) for a sham medication and asking them about their side-effect expectations. Associations between these measures and side-effect expectations whilst controlling for the PIL received were assessed using regression analyses. RESULTS: 82.8% of participants expected side-effects that were warned about in the PIL, and 29.1% expected side-effects that were not warned about. Participants who were younger, from White backgrounds, less optimistic, experienced increased anxiety and received the standard PIL were more likely to expect side-effects that were warned about. Those with higher beliefs about medicine overuse and lower trust in medicine development were more likely to expect side-effects that were not warned about. Higher somatization, baseline symptoms, modern health worries scores, and lower trust in pharmaceutical companies were associated with increased expectations for all side-effects. The results suggest we can not only rely on altering side-effect risk communication to reduce side-effect expectations and therefore nocebo effects. We must also consider patients' beliefs about trust in medicines. More work is needed to investigate this in a patientsample in which the medication is known to them.

Measuring the success of blinding in placebo-controlled trials: Should we be so quick to dismiss it?

'Blinding' involves concealing knowledge of which trial participants received the interventions from participants themselves and other trial personnel throughout the trial. Blinding reduces bias arising from the beliefs and expectations of these groups. It is agreed that where possible, blinding should be attempted, for example by ensuring that experimental and control treatments look the same. However, there is a debate about if we should measure whether blinding has been successful, this manuscript will discuss this controversy, including the benefits and risks of measuring blinding within the randomised controlled trial.

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls.

BACKGROUND: Placebo or sham controls are the standard against which the benefits and harms of many active interventions are measured. Whilst the components and the method of their delivery have been shown to affect study outcomes, placebo and sham controls are rarely reported and often not matched to those of the active comparator. This can influence how beneficial or harmful the active intervention appears to be. Without adequate descriptions of placebo or sham controls, it is difficult to interpret results about the benefits and harms of active interventions within placebo-controlled trials. To overcome this problem, we developed a checklist and guide for reporting placebo or sham interventions. METHODS AND FINDINGS: We developed an initial list of items for the checklist by surveying experts in placebo research (n = 14). Because of the diverse contexts in which placebo or sham treatments are used in clinical research, we consulted experts in trials of drugs, surgery, physiotherapy, acupuncture, and psychological interventions. We then used a multistage online Delphi process with 53 participants to determine which items were deemed to be essential. We next convened a group of experts and stakeholders (n = 16). Our main output was a modification of the existing Template for Intervention Description and Replication (TIDieR) checklist; this allows the key features of both active interventions and placebo or sham controls to be concisely summarised by researchers. The main differences between TIDieR-Placebo and the original TIDieR are the explicit requirement to describe the setting (i.e., features of the physical environment that go beyond geographic location), the need to report whether blinding was successful (when this was measured), and the need to present the description of placebo components alongside those of the active comparator. CONCLUSIONS: We encourage TIDieR-Placebo to be used alongside TIDieR to assist the reporting of placebo or sham components and the trials in which they are used.

The Effect of Positively Framing Side-Effect Risk in Two Different Formats on Side-Effect Expectations, Informed Consent and Credibility: A Randomised Trial of 16- to 75-Year-Olds in England.

INTRODUCTION: Reframing side-effect information in patient information leaflets (PILs) in terms of those who remain side-effect-free may reduce negative expectations and side-effects, although there are concerns this may impact informed consent. This study compared two versions of positively framed PILs with current practice to see which reduces side-effect expectations whilst maintaining informed consent and credibility. METHODS: We commissioned Ipsos MORI to conduct an online survey of 16- to 75-year-olds in England. 1067 people completed the study and were randomised to receive a PIL for a hypothetical new antibiotic that either communicated side-effects following current practice (n = 356), used positive framing with natural frequencies (n = 356), or positive framing with percentages (n = 355). After reading the leaflet, participants completed measures of their side-effect expectations, absolute risk perceptions, and satisfaction and credibility of the leaflet. RESULTS: Both positively framed PILs resulted in significantly lower side-effect expectations compared with the current PIL for all side-effects (ps < 0.001), apart from seizure. Pairwise comparisons showed no difference in side-effect expectations between the two positively framed PILs (ps > 0.626). The positively framed PIL using natural frequencies produced more accurate risk perceptions than the same leaflet using percentages; but performed equally to the current PIL. There was no difference between the leaflets in terms of satisfaction with or credibility of the PILs. CONCLUSION: Positively framed PILs using natural frequencies significantly reduced side-effect expectations and provided the most accurate risk perceptions without impacting satisfaction or credibility. Replication is needed with patients prescribed new medication and those with lower educational status.

A systematic review of factors associated with side-effect expectations from medical interventions.

BACKGROUND: Fear of side-effects can result in non-adherence to medical interventions, such as medication and chemotherapy. Side-effect expectations have been identified as strong predictors of later perception of side-effects. However, research investigating predictors of side-effect expectations is disparate. OBJECTIVE: To identify factors associated with side-effect expectations. SEARCH STRATEGY: We systematically searched Embase, Ovid MEDLINE, Global Health, PsycARTICLES, PsycINFO, Web of Science and Scopus. INCLUSION CRITERIA: Studies were included if they investigated associations between any predictive factor and expectations of side-effects from any medical intervention. DATA EXTRACTION AND SYNTHESIS: We extracted information about participant characteristics, medication, rates of side-effects expected and predictors of side-effect expectations. Data were narratively synthesized. MAIN RESULTS: We identified sixty-four citations, reporting on seventy-two studies. Predictors fell into five categories: personal characteristics, clinical characteristics, psychological traits and state, presentation format of information, and information sources used. Using verbal risk descriptors (eg 'common') compared to numerical descriptors (eg percentages), having lower quality of life or well-being, and currently experiencing symptoms were associated with increased side-effect expectations. DISCUSSION AND CONCLUSIONS: Decreasing unrealistic side-effect expectations may lead to decreased experience of side-effects and increased adherence to medical interventions. Widespread communications about medical interventions should describe the incidence of side-effects numerically. Evidence suggests that clinicians should take particular care with patients with lower quality of life, who are currently experiencing symptoms and who have previously experienced symptoms from treatment. Further research should investigate different clinical populations and aim to quantify the impact of the media and social media on side-effect expectations.

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

BackgroundEmergency 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.AimThis review aimed to summarise existing literature on children's activities and contacts made outside the home during unplanned school closures.MethodsIn 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.ResultsA 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.ConclusionEvidence 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.

The psychological impact of quarantine and how to reduce it: rapid review of the evidence.

The December, 2019 coronavirus disease outbreak has seen many countries ask people who have potentially come into contact with the infection to isolate themselves at home or in a dedicated quarantine facility. Decisions on how to apply quarantine should be based on the best available evidence. We did a Review of the psychological impact of quarantine using three electronic databases. Of 3166 papers found, 24 are included in this Review. Most reviewed studies reported negative psychological effects including post-traumatic stress symptoms, confusion, and anger. Stressors included longer quarantine duration, infection fears, frustration, boredom, inadequate supplies, inadequate information, financial loss, and stigma. Some researchers have suggested long-lasting effects. In situations where quarantine is deemed necessary, officials should quarantine individuals for no longer than required, provide clear rationale for quarantine and information about protocols, and ensure sufficient supplies are provided. Appeals to altruism by reminding the public about the benefits of quarantine to wider society can be favourable.

Research fatigue in COVID-19 pandemic and post-disaster research: Causes, consequences and recommendations.

PURPOSE: Research fatigue occurs when an individual or population of interest tires of engaging with research, consequently avoiding further participation. This paper considers research fatigue in the context of the current COVID-19 pandemic, to identify contributory factors and possible solutions for future post-disaster research. METHODOLOGY: We draw on examples from the literature and our own observations from the recruitment and data collection phases of qualitative and quantitative studies, to provide an overview of possible research fatigue in the current COVID-19 pandemic, with implications for future post-disaster research. FINDINGS: People affected by disasters sometimes receive multiple requests for study participation by separate teams who may not necessarily be coordinating their work. Not keeping participants informed of the research process or outcomes can lead to disillusionment. Being overburdened with too many research requests and failing to see any subsequent changes following participation may cause individuals to experience research fatigue. ORIGINALITY: Guidelines for researchers wishing to reduce the occurrence of research fatigue include ensuring greater transparency within research; sharing of results; and using oversight or gatekeeper bodies to aid coordination. Failure to restrict the number of times that people are asked to participate in studies risks poor participation rates. This can subsequently affect the quality of information with which to inform policy-makers and protect the health of the public during the COVID-19 pandemic or other public health disasters/emergencies.

Inadequate description of placebo and sham controls in a systematic review of recent trials.

BACKGROUND: Poorly described placebo/sham controls make it difficult to appraise active intervention benefits and harms. The 12-item Template for Intervention Description and Replication (TIDieR) checklist was developed to improve the reporting of active interventions. The extent to which TIDieR has been used to improve description of placebo or sham control is not known. MATERIALS AND METHODS: We systematically identified and examined all placebo/sham-controlled randomised trials published in 2018 in the top six general medical journals. We reported how many of the TIDieR checklist items were used to describe the placebo/sham control(s). We supplemented this with a sample of 100 placebo/sham-controlled trials from any journal and searched Google Scholar to identify placebo/sham-controlled trials citing TIDieR. RESULTS: We identified 94 placebo/sham-controlled trials published in the top journals in 2018. None reported using TIDieR, and none reported placebo or sham components completely. On average eight TIDieR items were addressed, with placebo/sham control name (100%) and when and how much was administered (97.9%) most commonly reported. Some items (rationale, 8.5%, whether there were modifications, 25.5%) were less often reported. In our sample of less well-cited journals, reporting was poorer (average of six items) and followed a similar pattern. Since TIDieR's first publication, six placebo-controlled trials have cited it according to Google Scholar. Two of these used the checklist to describe placebo controls; neither one completely desribed the placebo intervention. CONCLUSIONS: Placebo and sham controls are poorly described within randomised trials, and TIDieR is rarely used to guide these descriptions. We recommend developing guidelines to promote better descriptions of placebo/sham control components within clinical trials.

Positively Framed Risk Information in Patient Information Leaflets Reduces Side Effect Reporting: A Double-Blind Randomized Controlled Trial.

Background: Many medication side effects are the result of a psychologically mediated "nocebo effect," triggered by negative expectations. Purpose: This study investigated if changing how side effect information is framed in patient information leaflets (PILs) reduces symptom reporting. Methods: A total of 203 healthy volunteers aged 18 or over were recruited from December 1, 2015 to December 5, 2016 into a double-blind randomized controlled trial carried out at the Clinical Research Facility at King's College Hospital. King's Clinical Trial Unit randomized participants (stratified by gender) to receive a PIL for "a well-known tablet available without prescription" that used standard side effect risk information (e.g., "Common, 1 in 10 people will be affected") or positively framed wording (e.g., "Uncommon, 90% of people will not be affected"). After reading their PIL, participants took the tablet (a placebo) and completed symptom reports 1 hr later. The main outcomes included the number of participants who attributed symptoms to the tablet, and the number and severity of attributed symptoms. Results: A total of 101 participants were assigned the standard PIL and 102 the positive framed PIL. Significantly more standard PIL participants attributed symptoms to the tablet (n = 55, 54.5%) compared to positively framed PIL participants (n = 40, 39.2%), odds ratio (OR) = 0.66, 95% CI: 0.46-0.93. Positive framing did not significantly reduce the total number (p = .148) or severity (p = .149) of symptoms attributed to the tablet. Conclusion: Positive framing reduced the likelihood of participants attributing nocebo-induced side effects to the tablet. Work is needed to assess the effectiveness in a patient population. Clinical Trial information: ISRCTN47470030.

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. Statement of contribution What is already known on this subject? Many patients report non-specific side effects to their medication which may arise through a nocebo effect. Whether some people are particularly predisposed to experience nocebo effects remains unclear. What does this study add? Demographic and personality characteristics are poor predictors of symptom attribution to a sham medicine. Instead, context-specific factors that concern people's beliefs surrounding medicines, their current symptoms, and symptom expectations are more useful as predictors of symptom attribution.

Influencing Side-Effects to Medicinal Treatments: A Systematic Review of Brief Psychological Interventions.

Background: Nocebo effects contribute to a large proportion of the non-specific side-effects attributed to medications and are mainly generated through negative expectations. Previous reviews show that interventions designed to change participants' expectations have a small effect on pain experience. They are also effective in reducing side-effects caused by exposure to sham medications. To date, there has been no review of the influence of such interventions on symptoms attributed to real medicinal treatments. Objective: To review studies using a randomized controlled design testing the effect of brief psychological interventions compared to usual practice on the side-effect experience to medicinal treatments in healthy volunteers and patients. Methods: We searched Web of Science, Scopus, Medline, PsycINFO, PsycARTICLES, and Cochrane CENTRAL using search terms for randomized controlled trials along with "nocebo," "placebo effect," "medication," "side-effects," and associated terms. Studies were eligible if they studied a human population, used an active medicine, delivered a brief psychological intervention intended to influence side-effect reporting compared to usual care or no intervention, and used a randomized controlled design. Because of the heterogeneity of the literature we used a narrative synthesis and assessed evidence quality using the GRADE approach. Results: Our database search and supplementary search of the reference sections of included studies retrieved 50,140 citations. After screening, full text review and manual reference searches, 27 studies were included. The quality of the studies and evidence was judged to be low. The strongest and most consistent effect came from omitting side-effect information, although surprisingly de-emphasizing side-effects did not affect side-effect reporting. Other techniques, including priming, distraction, and altering the perception of branding, produced mixed results. Conclusion: Brief psychological interventions can influence side-effect reporting to active medications. Research is currently investigating new ways to de-emphasize side-effects whilst still upholding informed consent, but larger confirmatory trials with suitable control groups are needed. The literature in this area would be improved by more detailed reporting of studies.