Jim McCambridge

Systematic review of the Hawthorne effect: New concepts are needed to study research participation effects

Objectives This study aims to (1) elucidate whether the Hawthorne effect exists, (2) explore under what conditions, and (3) estimate the size of any such effect. Study Design and Setting This systematic review summarizes and evaluates the strength of available evidence on the Hawthorne effect. An inclusive definition of any form of research artifact on behavior using this label, and without cointerventions, was adopted. Results Nineteen purposively designed studies were included, providing quantitative data on the size of the effect in eight randomized controlled trials, five quasiexperimental studies, and six observational evaluations of reporting on ones behavior by answering questions or being directly observed and being aware of being studied. Although all but one study was undertaken within health sciences, study methods, contexts, and findings were highly heterogeneous. Most studies reported some evidence of an effect, although significant biases are judged likely because of the complexity of the evaluation object. Conclusion Consequences of research participation for behaviors being investigated do exist, although little can be securely known about the conditions under which they operate, their mechanisms of effects, or their magnitudes. New concepts are needed to guide empirical studies.

Liver cirrhosis mortality rates in Britain from 1950 to 2002: an analysis of routine data

BACKGROUND Rates of mortality due to cirrhosis of the liver are an important indicator of population levels of alcohol harm. Total recorded alcohol consumption in Britain doubled between 1960 and 2002, giving rise to a need to examine and assess cirrhosis mortality trends. METHODS Mortality rates were calculated for all ages and for specific age-groups (15-44 years and 45-64 years) for cirrhosis of the liver. Rates were directly age-standardised to the European standard population and compared with rates from 12 western European countries for the period 1955-2001. FINDINGS Cirrhosis mortality rates increased steeply in Britain during the 1990s. Between the periods 1987-1991, and 1997-2001, cirrhosis mortality in men in Scotland more than doubled (104% increase) and in England and Wales rose by over two-thirds (69%). Mortality in women increased by almost half (46% in Scotland and 44% in England and Wales). These relative increases are the steepest in western Europe, and contrast with the declines apparent in most other countries examined, particularly those of southern Europe. Cirrhosis mortality rates in Scotland are now one of the highest in western Europe, in 2002 being 45.2 per 100,000 in men and 19.9 in women. INTERPRETATION Current alcohol policies in Britain should be assessed by the extent to which they can successfully halt the adverse trends in liver cirrhosis mortality. The situation in Scotland warrants particular attention.

Adult Consequences of Late Adolescent Alcohol Consumption: A Systematic Review of Cohort Studies

In a systematic review of cohort studies of adolescent drinking and later outcomes, Jim McCambridge and colleagues show that although studies suggest links to worse adult physical and mental health and social consequences, existing evidence is of poor quality.

Can simply answering research questions change behaviour? Systematic review and meta analyses of brief alcohol intervention trials

Background Participant reports of their own behaviour are critical for the provision and evaluation of behavioural interventions. Recent developments in brief alcohol intervention trials provide an opportunity to evaluate longstanding concerns that answering questions on behaviour as part of research assessments may inadvertently influence it and produce bias. The study objective was to evaluate the size and nature of effects observed in randomized manipulations of the effects of answering questions on drinking behaviour in brief intervention trials. Methodology/Principal Findings Multiple methods were used to identify primary studies. Between-group differences in total weekly alcohol consumption, quantity per drinking day and AUDIT scores were evaluated in random effects meta-analyses. Ten trials were included in this review, of which two did not provide findings for quantitative study, in which three outcomes were evaluated. Between-group differences were of the magnitude of 13.7 (−0.17 to 27.6) grams of alcohol per week (approximately 1.5 U.K. units or 1 standard U.S. drink) and 1 point (0.1 to 1.9) in AUDIT score. There was no difference in quantity per drinking day. Conclusions/Significance Answering questions on drinking in brief intervention trials appears to alter subsequent self-reported behaviour. This potentially generates bias by exposing non-intervention control groups to an integral component of the intervention. The effects of brief alcohol interventions may thus have been consistently under-estimated. These findings are relevant to evaluations of any interventions to alter behaviours which involve participant self-report.

Consultations about changing behaviour

Health threatening behaviours are the commonest cause of premature illness and death in the developed world, affecting the sustainability of our health services and society. 1 Almost every healthcare worker interacting with almost every patient has an important opportunity to change health behaviour. Examples include a general practitioner talking to a patient about smoking or exercise, a health visitor engaging a mother about her child’s diet, an accident and emergency house officer talking to an injured patient about alcohol, a renal nurse discussing fluid intake, and a dental hygienist discussing flossing. These consultations can be difficult to navigate, however, and practitioners often make a cursory attempt to satisfy external guidelines or end up avoiding the subject altogether. Here, we consider how the flexible use of a guiding style could make health promotion more satisfying and effective.

Randomized controlled trial of the effects of completing the Alcohol Use Disorders Identification Test questionnaire on self-reported hazardous drinking

AIMS The direct effects of screening on drinking behaviour have not previously been evaluated experimentally. We tested whether screening reduces self-reported hazardous drinking in comparison with a non-screened control group. DESIGN Two-arm randomized controlled trial (RCT), with both groups blinded to the true nature of the study. SETTING AND PARTICIPANTS A total of 421 university students aged 18-24 years, recruited in five London student unions. INTERVENTIONS Both groups completed a brief pen-and-paper general health and socio-demographic questionnaire, which for the experimental group also included the 10-item Alcohol Use Disorders Identification Test (AUDIT) screening questionnaire. MEASUREMENTS The primary outcome was the between-group difference in AUDIT score at 2-3-month follow-up. Eight secondary outcomes comprised other aspects of hazardous drinking, including dedicated measures of alcohol consumption, problems and dependence. FINDINGS A statistically significant effect size of 0.23 (0.01-0.45) was detected on the designated primary outcome. The marginal nature of the statistical significance of this effect was apparent in additional analyses with covariates. Statistically significant differences were also obtained in three of eight secondary outcomes, and the observed effect sizes were not dissimilar to the known effects of brief interventions. CONCLUSIONS It is unclear to what extent these findings represent the effects of screening alone, a Hawthorne effect in which drinking behaviour has changed in response to monitoring, or whether they indicate reporting bias. These possibilities have important implications both for the dissemination of screening as an intervention in its own right and for behavioural intervention trials methodology.

Methodological Challenges in Online Trials

Health care and health care services are increasingly being delivered over the Internet. There is a strong argument that interventions delivered online should also be evaluated online to maximize the trial’s external validity. Conducting a trial online can help reduce research costs and improve some aspects of internal validity. To date, there are relatively few trials of health interventions that have been conducted entirely online. In this paper we describe the major methodological issues that arise in trials (recruitment, randomization, fidelity of the intervention, retention, and data quality), consider how the online context affects these issues, and use our experience of one online trial evaluating an intervention to help hazardous drinkers drink less (DownYourDrink) to illustrate potential solutions. Further work is needed to develop online trial methodology.

5-Year Trends in Use of Hallucinogens and Other Adjunct Drugs among UK Dance Drug Users

Aims: To describe and assess trends in the use of hallucinogens and other adjunct drugs over a 5-year period. Design: Repeated-measures cross-sectional survey. Setting and Participants: Annual magazine-based survey targeting people who use drugs in dance contexts. Measurements: Lifetime use prevalence (ever used); age of first use; current use prevalence (any use within the last month), and extent of use within the last month (number of days used) for LSD, psilocybin, ketamine, GHB and nitrates. Findings: Prevalence increases for psilocybin, ketamine, GHB and nitrates use have been detected, with a sharp recent rise in current psilocybin use in 2002–2003 contrasting with more gradual and comprehensive evidence of increased ketamine use throughout the period 1999–2003. The declining prevalence of LSD use in general population surveys is replicated in this sentinel population study. Conclusions: The rise in prevalence of hallucinogen and other adjunct drugs identified among dance drug users may be mirrored by wider prevalence increases among young people with a consequent need to study these trends carefully and to develop effective interventions, where required.

Change over time in alcohol consumption in control groups in brief intervention studies: systematic review and meta-regression study

Reactivity to assessment has attracted recent attention in the brief alcohol intervention literature. This systematic review sought to examine the nature of change in alcohol consumption over time in control groups in brief intervention studies. Primary studies were identified from existing reviews published in English language, peer-reviewed journals between 1995 and 2005. Change in alcohol consumption and selected study-level characteristics for each primary study were extracted. Consumption change data were pooled in random effects models and meta-regression was used to explore predictors of change. Eleven review papers reported the results of 44 individual studies. Twenty-six of these studies provided data suitable for quantitative study. Extreme heterogeneity was identified and the extent of observed reduction in consumption over time was greater in studies undertaken in Anglophone countries, with single gender study participants, and without special targeting by age. Heterogeneity was reduced but was still substantial in a sub-set of 15 general population studies undertaken in English language countries. The actual content of the control group procedure itself was not predictive of reduction in drinking, nor were a range of other candidate variables including setting, the exclusion of dependent drinkers, the collection of a biological sample at follow-up, and duration of study. Further investigations may yield novel insights into the nature of behaviour change with potential to inform brief interventions design.

Training practitioners to deliver opportunistic multiple behaviour change counselling in primary care: a cluster randomised trial.

Objectives To evaluate the effect of training primary care health professionals in behaviour change counselling on the proportion of patients self reporting change in four risk behaviours (smoking, alcohol use, exercise, and healthy eating). Design Cluster randomised trial with general practices as the unit of randomisation. Setting General practices in Wales. Participants 53 general practitioners and practice nurses from 27 general practices (one each at all but one practice) recruited 1827 patients who screened positive for at least one risky behaviour. Intervention Behaviour change counselling was developed from motivational interviewing to enable clinicians to enhance patients’ motivation to change health related behaviour. Clinicians were trained using a blended learning programme called Talking Lifestyles. Main outcome measures Proportion of patients who reported making beneficial changes in at least one of the four risky behaviours at three months. Results 1308 patients from 13 intervention and 1496 from 14 control practices were approached: 76% and 72% respectively agreed to participate, with 831 (84%) and 996 (92%) respectively screening eligible for an intervention. There was no effect on the primary outcome (beneficial change in behaviour) at three months (362 (44%) v 404 (41%), odds ratio 1.12 (95% CI 0.90 to 1.39)) or on biochemical or biometric measures at 12 months. More patients who had consulted with trained clinicians recalled consultation discussion about a health behaviour (724/795 (91%) v 531/966 (55%), odds ratio 12.44 (5.85 to 26.46)) and intended to change (599/831 (72%) v 491/996 (49%), odds ratio 2.88 (2.05 to 4.05)). More intervention practice patients reported making an attempt to change (328 (39%) v 317 (32%), odds ratio 1.40 (1.15 to 1.70)), a sustained behaviour change at three months (288 (35%) v 280 (28%), odds ratio 1.36 (1.11 to 1.65)), and reported slightly greater improvements in healthy eating at three and 12 months, plus improved activity at 12 months. Training cost £1597 per practice. Discussion Training primary care clinicians in behaviour change counselling using a brief blended learning programme did not increase patients reported beneficial behaviour change at three months or improve biometric and a biochemical measure at 12 months, but it did increase patients’ recollection of discussing behaviour change with their clinicians, intentions to change, attempts to change, and perceptions of having made a lasting change at three months. Enduring behaviour change and improvements in biometric measures are unlikely after a single routine consultation with a clinician trained in behaviour change counselling without additional intervention. Trial registration ISRCTN 22495456