Development of the generic, multidimensional Treatment Expectation Questionnaire (TEX-Q) through systematic literature review, expert surveys and qualitative interviews.

OBJECTIVE: Patients' expectations-as a central mechanism of placebo and nocebo effects-are an important predictor of health outcomes. However, the lack of a way to assess expectations across different settings restricts progress in understanding the role of expectations and to quantify their importance in medical and psychological treatments. The aim of this study was to develop a theory-based, generic, multidimensional measure assessing patient expectations of medical and psychological treatments. DESIGN: The Treatment Expectation Questionnaire (TEX-Q) was developed based on the integrative model of expectations and a systematic literature review of treatment expectation scales. After creating a comprehensive item pool, the scale was further refined by use of expert ratings and patient interviews. SETTING: Patients were recruited in primary care at two hospitals in Hamburg, Germany. PARTICIPANTS: 13 scientific experts participated in the expert survey. 11 patients waiting for psychological or surgical treatments participated in the qualitative interviews. RESULTS: The 2×2×2 multidimensional structure of the TEX-Q assesses two expectation constructs (probabilistic vs value-based) across two outcome domains with two valences (direct benefits and adverse events, broader positive and negative impact), plus process and behavioural control expectations. We examined 583 items from 38 scales identified in the systematic review and developed 78 initial items. Content validity was then rated by experts according to item fit and comprehensibility. The best 53 items were further evaluated for comprehensibility, acceptability, phrasing preference and understanding by interviewing patients prior to treatment using the 'think aloud' technique. This resulted in a first 35-item version of the TEX-Q. CONCLUSIONS: The TEX-Q is a generic, multidimensional measure to assess patient expectations of medical and psychological treatments and allows comparison of the impact of multidimensional expectations across different conditions. The final TEX-Q will be available after psychometric validation.

Interplay of subjective and objective economic well-being on the mental health of Norwegian adolescents.

Objective and subjective socioeconomic status (SES) are important determinants of adolescent mental health problems, but we know less about how they interact. Research has demonstrated independent associations of both variables to mental health problems, but less is known about their relationship and role in adolescent mental health problems. Data from the youth@hordaland study, a survey of 9079 Norwegian adolescents aged 16 to 19 were linked to official tax register information about household income, and was used to examine the relationship between perceived economic well-being and household income. We also investigated how perceptions of economic well-being interacted with household income in relation to adolescent mental health problems. The overall relationship between perceived and actual household income was relatively low (r = .33 [95% CI = 0.32-0.35], p < .001, although this relationship was somewhat higher in adolescents with either low or high household incomes. Low income and unfavorable perceptions of economic well-being were associated with most mental health problems. Importantly, the mental health benefits associated with higher income appeared to depend on the adolescents' perceptions of their family's relative economic position. The results show moderate associations between perceived economic well-being and household income and that the influence of perceived economic well-being on conduct- and peer problems depended on the level of household income. Symptoms of depression explained some of this association. Knowledge about how the adolescents feel about their relative economic standing may be potentially important information for adolescents with mental health problems, and additional work is needed to understand how adolescents establish perceptions of economic rank.

What is associated with increased side effects and lower perceived efficacy following switching to a generic medicine? A New Zealand cross-sectional patient survey.

OBJECTIVE: Following a switch from either a generic or branded antidepressant (venlafaxine) to a new generic, we investigated the factors associated with a preference for branded medicines, side effects reported following switching and efficacy ratings of the new generic drug. DESIGN: A cross-sectional survey of patients switched to a new generic. SETTING: Patients accessing venlafaxine information online from the New Zealand government pharmaceuticals funding website. PARTICIPANTS: 310 patients, comprising 205 originally on branded venlafaxine and 105 previously taking a generic version. MAIN OUTCOME MEASURES: An online questionnaire assessing demographic factors, perceived sensitivity to medicines, trust in pharmaceutical agencies, sources of switch information, preference for branded medicine, new medicine perceptions, side effects and efficacy ratings. RESULTS: Preference for branded medicine was significantly stronger in older patients (OR=1.04, 95% CI 1.01 to 1.05), those taking branded venlafaxine (OR=2.02, 95% CI 1.13 to 3.64) and patients with a higher perceived sensitivity to medicine (OR=1.23, 95% CI 1.06 to 1.19). Different factors predicted side effects in those switching from the branded and those switching from the generic venlafaxine. Trust in pharmaceutical agencies and the number of side effects were significant predictors of efficacy ratings of the new generic in both patients switching from a branded and those switching from a generic version of venlafaxine. CONCLUSIONS: In patients switching from a branded medicine and those already taking a generic, different demographic and psychological factors are associated with preference for branded medicine, side effect reporting and perceived efficacy of the new drug. When switching to new generic, there appears to be a close bidirectional relationship between the experience of side effects and perceived drug efficacy. Trust in pharmaceutical agencies impacts directly on perceived efficacy and increasing such trust could reduce the nocebo response following a generic switch.

Cumulative effects of negative life events and family stress on children's mental health: the Bergen Child Study.

PURPOSE: Numerous studies have documented that lower socioeconomic status (SES) is associated with increased mental health problems in children. One proposed pathway for this association has been differential exposure to accumulated risk factors in children of lower SES. The aim of the current study was to investigate the socioeconomic distribution of exposure to negative life events and family stress and to examine the direct and interactive association between lower SES and exposure to life events and family stress in relation with mental health problems. METHODS: Using cross-sectional data from the second wave of the Bergen Child Study (conducted in 2006), the current study investigated the association between lower SES and exposure to negative life events, family life stressors, and mental health problems in a sample of 2043 Norwegian 11-13 years and their parents. Information about mental health was self-reported by the children using the Strengths and Difficulties Questionnaire, whereas information about SES and exposure to negative life events and family stressors were provided by their parents. RESULTS: The findings showed that lower SES was associated with more symptoms of emotional-, conduct-, hyperactivity/inattention-, and peer problems and that exposure to life events and family stress explained some of this association (10-29% of the total effects). CONCLUSIONS: Low SES and higher prevalence of negative life events and family stressors were associated with more symptoms of mental health problems. Overall, the effect sizes were smaller than previous investigations (f 2s = 0.015-0.031), perhaps suggesting a buffering effect of the social safety net in place in Norway.

Economic volatility in childhood and subsequent adolescent mental health problems: a longitudinal population-based study of adolescents.

OBJECTIVE: The aim of the current paper was to investigate the association between the patterns of duration, timing and sequencing of exposure to low family income during childhood, and symptoms of mental health problems in adolescence. SETTING: Survey administered to a large population-based sample of Norwegian adolescents. PARTICIPANTS: Survey data from 9154 participants of 16-19 years age (53% participation rate; 52.7% girls) were linked to registry-based information about childhood family income from tax return data. OUTCOME MEASURES: Mental health outcomes were symptoms of emotional, conduct, hyperactivity, peer problems and general mental health problems measured with the Strengths and Difficulties Questionnaire, symptoms of depression measured with Short Mood and Feelings Questionnaire and symptoms of attention-deficit/hyperactivity disorder (ADHD) measured with the Adult ADHD Self-Report Scale. RESULTS: Latent class analysis and the BCH approach in Mplus were used to examine associations between patterns of poverty exposure and mental health outcomes. Four latent classes of poverty exposure emerged from the analysis. Participants moving into poverty (2.3%), out of poverty (3.5%) or those chronically poor (3.1%) had more symptoms of mental health problems (Cohen's d=16-.50) than those with no poverty exposure (91.1%). This pattern was, however, not found for symptoms of ADHD. The pattern of results was confirmed in robustness checks using observed data. CONCLUSIONS: Exposure to poverty in childhood was found to be associated with most mental health problems in adolescence. There was no strong suggestion of any timing or sequencing effects in the patterns of associations.

Medical specialists' attitudes to prescribing biosimilars.

PURPOSE: Biosimilars are a cost-effective alternative to biologics that could improve patients' access to expensive biological medicines. Currently, there are little data on doctors' perceptions of biosimilars and in what situations they are comfortable prescribing biosimilars. In this study, we investigated medical specialists' perceptions of biosimilars and the factors associated with the acceptance of biosimilars. METHODS: A national sample of 110 of 327 medical specialists working in the areas of rheumatology, dermatology, gastroenterology, oncology and haematology completed an online questionnaire examining attitudes towards prescribing biosimilars, indication extrapolation and switching patients to a biosimilar. RESULTS: Most specialists held positive views of biosimilars, with between 54 and 74% confident in the safety, efficacy, manufacturing and pharmacovigilance of biosimilars. Seventy-one percent of specialists agreed that they would prescribe biosimilars for all or some conditions meeting relevant clinical criteria. Specialists were less confident about indication extrapolation and switching patients from an existing biologic. Acceptance of biosimilars was significantly associated with a lower perceived time to explain a biosimilar to a patient and lower number of weekly patient appointments. The most common situations that they would not prescribe a biosimilar was where there was a lack of clinical data supporting efficacy (32%), or evidence of adverse effects (17%). CONCLUSIONS: Medical specialists held generally positive attitudes towards biosimilars but were less confident in indication extrapolation and switching patients from a biologic. Providing clinicians with guidance on how to explain biosimilars to patients and written patient material may help overcome some of the barriers to the use of biosimilars. Copyright © 2017 John Wiley & Sons, Ltd.

Illness Perceptions and Mortality in Patients With Gout: A Prospective Observational Study.

OBJECTIVE: To examine whether illness perceptions independently predict mortality in early-onset gout. METHODS: Between December 2006 and January 2014, a total of 295 participants with early-onset gout (<10 years) were recruited in Auckland and Wellington, New Zealand. The participants were followed up until February 2015, and mortality information was collected. Participants with complete data were included in the current study (n = 242). Cox proportional hazards models were used to examine the association between illness perceptions and mortality risk, after adjustment for covariates associated with disease severity and mortality in gout. RESULTS: In a Cox proportional hazards model adjusted for predictors of disease severity and mortality in gout (number of tophi, serum urate level, and frequency of flares), consequence beliefs, identity beliefs, concern beliefs, and emotional response to gout were associated with all-cause mortality (hazard ratios [HRs] 1.29, 1.15, 1.18, and 1.19, respectively; P < 0.05 for all). In the fully saturated model, the association between consequence beliefs and mortality remained robust after additional adjustment for ethnicity, disease duration, diuretic use, serum creatinine, and pain score (HR 1.18 [95% confidence interval 1.02-1.37]; P = 0.029). CONCLUSION: Negative beliefs about the impact of gout and severity of symptoms, as well as concerns about gout and the emotional response to gout, were independently associated with all-cause mortality. Illness perceptions are important and potentially modifiable risk factors to target in future interventions.

The Validity and Clinical Utility of the COVERS Scale and Pain Assessment Tool for Assessing Pain in Neonates Admitted to an Intensive Care Unit.

OBJECTIVES: Infants admitted to a neonatal intensive care unit (NICU) are routinely subject to a range of painful procedures. However, pain assessments in NICUs are under-utilized due to a lack of a gold standard pain measure. In this study we assessed the psychometric properties and clinical utility of the COVERS and Pain Assessment Tool (PAT), in a neonatal unit. METHODS: We had 72 nurses use the scales to assess pain at baseline and during a heel-lance procedure in 80 NICU infants. An independent research observer and the infant's mother also completed pain ratings. After the study, we assessed nurse preference and clinical utility ratings for both scales. RESULTS: The COVERS had satisfactory internal consistency at baseline (Cronbach α=0.74) and heel lance (α=0.78), as did the PAT (baseline α=0.79, heel lance α=0.85). Intraclass correlation coefficients demonstrated good inter-rater reliability at baseline and heel lance, respectively, for both the COVERS (0.82 and 0.80) and the PAT (0.83 and 0.86). There were strong associations between total scores on the 2 scales at baseline (r=0.81, P<0.001) and heel lance (r=0.91, P<0.001), between researcher's ratings and total COVERS (ρ=0.75, P<0.001) and PAT scores (ρ=0.69, P<0.001), and between maternal ratings and total COVERS (r=0.74, P<0.05) and PAT scores (r=0.65, P<0.05). Both scales were sensitive to pain and nonpain events. Reliability and validity was mostly upheld across gestational age. Most nurses preferred the COVERS (52%) to the PAT (16%), and 32% had no preference. DISCUSSION: This study builds on evidence for the COVERS scale and the PAT; both scales were reliable and valid measures of acute pain in neonates as premature as 24-week gestational age.

Impact of brand or generic labeling on medication effectiveness and side effects.

OBJECTIVE: Branding medication with a known pharmaceutical company name or product name bestows on the drug an added assurance of authenticity and effectiveness compared to a generic preparation. This study examined the impact of brand name and generic labeling on medication effectiveness and side effects. METHOD: 87 undergraduate students with frequent headaches took part in the study. Using a within-subjects counterbalanced design, each participant took tablets labeled either as brand name "Nurofen" or "Generic Ibuprofen" to treat each of 4 headaches. In reality, half of the tablets were placebos, and half were active ibuprofen (400 mg). Participants recorded their headache pain on a verbal descriptor and visual analogue scale prior to taking the tablets, and again 1 hour afterward. Medication side effects were also reported. RESULTS: Pain reduction following the use of brand name labeled tablets was similar in active ibuprofen or a placebo. However, if the tablets had a generic label, placebo tablets were significantly less effective compared to active ibuprofen. Fewer side effects were attributed to placebo tablets with brand name labeling compared to the same placebo tablets with a generic label. CONCLUSIONS: Branding of a tablet appears to have conferred a treatment benefit in the absence of an active ingredient, while generic labeled tablets were substantially less effective if they contained no active ingredient. Branding is also associated with reduced attribution of side effects to placebo tablets. Future interventions to improve perceptions of generics may have utility in improving treatment outcomes from generic drugs.

What characterizes individuals developing chronic whiplash?: The Nord-Trøndelag Health Study (HUNT).

OBJECTIVE: Most individuals experiencing whiplash accidents recover rapidly. A considerable proportion, however, develop chronic symptoms. Psychological factors may slow recovery, possibly by increasing the likelihood of other symptoms being misattributed to, and amplified by the whiplash injury. We aimed to investigate how pre-injury mental and somatic symptoms, self-rated health, use of health-services and medications, health-behavior and socio-demographics predict the development of chronic whiplash. METHODS: Data from two waves of a large, population based study (HUNT2 (baseline) and HUNT3) were used. Individuals reporting no whiplash at baseline were identified in HUNT3. Characteristics reported at baseline were compared between those who had developed chronic whiplash in HUNT3 (n=199) and those who had not (n=20,600), using Pearson's chi-squared tests, independent sample t-tests and logistic regression analyses. RESULTS: Individuals developing chronic whiplash reported worse baseline health than those reporting no chronic whiplash. Poor self-rated health was a strong risk factor for subsequent chronic whiplash (OR=2.26, 95%CI: 1.68-3.04). Musculoskeletal pain also increased the risk (OR=1.21, 95%CI: 1.15-1.26), as did diffuse somatic symptoms (OR=2.09, 95%CI: 1.47-2.96), use of different health services (OR=1.31, 95%CI: 1.19-1.45), high use of medications (OR=1.28, 95%CI: 1.14-1.43) and symptoms of anxiety (OR=1.93, 95%CI: 1.39-2.68). Physical activity was protective (OR=0.67, 95%CI: 0.49-0.91). Most socio-demographic variables were not significantly associated with chronic whiplash. CONCLUSION: Poor somatic and mental pre-injury health increased the risk of subsequent chronic whiplash. This suggests that chronic whiplash is not merely an organic disorder, and highlights the importance of individual expectations, symptom reattribution and amplification in development of chronic whiplash.

The effect of an apparent change to a branded or generic medication on drug effectiveness and side effects.

OBJECTIVE: Generic medications are associated with reduced perceived effectiveness, increased perceived adverse effects, and increased rates of nonadherence compared with brand-name medications. This study examined the effect of an apparent medication formulation change on subjective and objective measures of medication effectiveness and medication side effects. METHODS: Sixty-two university students participated in a study purportedly testing the effectiveness of fast-acting ß-blocker medications in reducing preexamination anxiety. All tablets were placebos. In session 1, all participants received a yellow tablet ("Betaprol"). In session 2, participants were randomly allocated to receive Betaprol (no change condition) or a white tablet labeled either as "Novaprol" (branded change condition) or "Generic" (generic change condition). Blood pressure and state anxiety were measured before and after tablet ingestion. Side effects attributed to medication were assessed. RESULTS: The no change group showed significantly greater decreases in systolic blood pressure (mean [M] [standard deviation] = -7.72 mm Hg, standard error [SE] = 1.45) than the branded change (M = -2.75 mm Hg, SE = 1.44, p = .02) and generic change (M = -3.26 mm Hg, SE = 1.45, p = .03) groups. The no-change group showed significantly greater decreases in state anxiety (M = -1.53, SE = 0.33) than the branded change (M = -0.50, SE = 0.33, p = .03) and generic change (M = -0.52, SE = 0.33, p = .04) groups. Significantly more side effects were attributed to the medication in the generic change (M = 1.83, SE = 0.23) (but not the branded change) condition when compared with the no change condition (M = 0.87, SE = 0.31, p = .03). CONCLUSIONS: Medication formulation change, particularly to generic medication, seems to be associated with reduced subjective and objective measures of medication effectiveness and increased side effects.

Illness perceptions in patients with gout and the relationship with progression of musculoskeletal disability.

OBJECTIVE: Illness perceptions are key determinants of behavior directed at managing disease. Although suboptimal disease management has been reported in patients with gout, patients' perceptions of illness have not been systematically studied. The aim of this study was to examine illness perceptions in patients with gout. METHODS: A total of 142 patients with gout for <10 years were recruited from primary and secondary care settings. Participants completed a gout-specific Brief Illness Perception Questionnaire, questionnaires about medication beliefs and adherence to urate-lowering therapy (ULT), and had a comprehensive assessment of gout disease activity. Serum urate, flare frequency, and Health Assessment Questionnaire (HAQ-II) scores were recorded at baseline and after 1 year. RESULTS: Patients viewed gout as a chronic condition that was responsive to treatment but not strongly influenced by personal actions. Overall, gout was seen as having a moderate impact on their life. Most patients believed that gout was caused by dietary factors. Adherence to ULT was positively associated with a greater perceived understanding of gout and inversely associated with perceived severity and consequences of disease. Of the clinical factors assessed, pain scores were most strongly associated with negative illness perception scores at baseline. Baseline illness perception scores (perceived severity of symptoms and consequences, lower personal and treatment control) predicted worsening musculoskeletal disability at 1 year as determined by the HAQ-II. This relationship was independent of baseline disability scores. CONCLUSION: Negative or pessimistic views about gout are associated with poorly controlled disease, lower adherence to ULT, and progression of musculoskeletal disability in patients with gout.

Changes in patient drawings of the heart identify slow recovery after myocardial infarction.

OBJECTIVE: The objective of this study was to investigate how changes in heart attack patients' drawings of their heart over the recovery period relate to psychological and functional recovery. METHODS: Sixty-nine inpatients admitted for acute myocardial infarction at the coronary care unit at a metropolitan hospital completed questionnaires at discharge, including a drawing of what they thought had happened to their heart after their heart attack. Fifty-six patients returned follow-up questionnaires at 3 and 6 months, including heart drawings, cardiac anxiety, time to return to work, changes in exercise frequency, and healthcare use. RESULTS: Increases in the size of the heart drawn at the 3-month follow-up relative to discharge were related to slower return to work (r = 0.48, p < .01), higher cardiac anxiety (r = 0.35, p < .05), and more phone calls to health services (r = 0.37, p < .05) as well as increases in worry about another myocardial infarction (r = 0.39, p < .01), increased activity restriction (r = 0.34, p < .05), higher use of alternative medicines (r = 0.40, p < .05), and less frequent exercise (r = -0.39, p < .05) relative to before the myocardial infarction. CONCLUSIONS: Drawings of the heart may be useful in identifying patients who have experienced heart attacks who are likely to develop greater heart-focused anxiety, complaints of ill health, and higher use of health care. Increases in the size of the patient's drawing of the heart may reflect increases in the extent to which their heart condition plays on their mind and directs their daily activities.