Are there valid proxy measures of clinical behaviour?

Background: Accurate measures of health professionals' clinical practice are critically important to guide health policy decisions, as well as for professional self-evaluation and for research-based investigation of clinical practice and process of care. It is often not feasible or ethical to measure behaviour through direct observation, and rigorous behavioural measures are difficult and costly to use. The aim of this review was to identify the current evidence relating to the relationships between proxy measures and direct measures of clinical behaviour. In particular, the accuracy of medical record review, clinician self-reported and patient-reported behaviour was assessed relative to directly observed behaviour. Methods: We searched: PsycINFO; MEDLINE; EMBASE; CINAHL; Cochrane Central Register of Controlled Trials; science/social science citation index; Current contents (social & behavioural med/clinical med); ISI conference proceedings; and Index to Theses. Inclusion criteria: empirical, quantitative studies; and examining clinical behaviours. An independent, direct measure of behaviour (by standardised patient, other trained observer or by video/audio recording) was considered the 'gold standard' for comparison. Proxy measures of behaviour included: retrospective self-report; patient-report; or chart-review. All titles, abstracts, and full text articles retrieved by electronic searching were screened for inclusion and abstracted independently by two reviewers. Disagreements were resolved by discussion with a third reviewer where necessary. Results: Fifteen reports originating from 11 studies met the inclusion criteria. The method of direct measurement was by standardised patient in six reports, trained observer in three reports, and audio/video recording in six reports. Multiple proxy measures of behaviour were compared in five of 15 reports. Only four of 15 reports used appropriate statistical methods to compare measures. Some direct measures failed to meet our validity criteria. The accuracy of patient report and chart review as proxy measures varied considerably across a wide range of clinical actions. The evidence for clinician self-report was inconclusive. Conclusion: Valid measures of clinical behaviour are of fundamental importance to accurately identify gaps in care delivery, improve quality of care, and ultimately to improve patient care. However, the evidence base for three commonly used proxy measures of clinicians' behaviour is very limited. Further research is needed to better establish the methods of development, application, and analysis for a range of both direct and proxy measures of behaviour

Using psychological theory to understand the clinical management of type 2 diabetes in Primary Care : a comparison across two European countries

Peer reviewedPublisher PD

Explaining the effects of an intervention designed to promote evidence-based diabetes care : a theory-based process evaluation of a pragmatic cluster randomised controlled trial

Background The results of randomised controlled trials can be usefully illuminated by studies of the processes by which they achieve their effects. The Theory of Planned Behaviour (TPB) offers a framework for conducting such studies. This study used TPB to explore the observed effects in a pragmatic cluster randomised controlled trial of a structured recall and prompting intervention to increase evidence-based diabetes care that was conducted in three Primary Care Trusts in England. Methods All general practitioners and nurses in practices involved in the trial were sent a postal questionnaire at the end of the intervention period, based on the TPB (predictor variables: attitude; subjective norm; perceived behavioural control, or PBC). It focussed on three clinical behaviours recommended in diabetes care: measuring blood pressure; inspecting feet; and prescribing statins. Multivariate analyses of variance and multiple regression analyses were used to explore changes in cognitions and thereby better understand trial effects. Results Fifty-nine general medical practitioners and 53 practice nurses (intervention: n = 55, 41.98% of trial participants; control: n = 57, 38.26% of trial participants) completed the questionnaire. There were no differences between groups in mean scores for attitudes, subjective norms, PBC or intentions. Control group clinicians had 'normatively-driven' intentions (i.e., related to subjective norm scores), whereas intervention group clinicians had 'attitudinally-driven' intentions (i.e., related to attitude scores) for foot inspection and statin prescription. After controlling for effects of the three predictor variables, this group difference was significant for foot inspection behaviour (trial group × attitude interaction, beta = 0.72, p < 0.05; trial group × subjective norm interaction, beta = -0.65, p < 0.05). Conclusion Attitudinally-driven intentions are proposed to be more consistently translated into action than normatively-driven intentions. This proposition was supported by the findings, thus offering an interpretation of the trial effects. This analytic approach demonstrates the potential of the TPB to explain trial effects in terms of different relationships between variables rather than differences in mean scores. This study illustrates the use of theory-based process evaluation to uncover processes underlying change in implementation trials.European Union ReBEQI projec

Developing the content of two behavioural interventions : using theory-based interventions to promote GP management of upper respiratory tract infection without prescribing antibiotics #1

Background: Evidence shows that antibiotics have limited effectiveness in the management of upper respiratory tract infection (URTI) yet GPs continue to prescribe antibiotics. Implementation research does not currently provide a strong evidence base to guide the choice of interventions to promote the uptake of such evidence-based practice by health professionals. While systematic reviews demonstrate that interventions to change clinical practice can be effective, heterogeneity between studies hinders generalisation to routine practice. Psychological models of behaviour change that have been used successfully to predict variation in behaviour in the general population can also predict the clinical behaviour of healthcare professionals. The purpose of this study was to design two theoretically-based interventions to promote the management of upper respiratory tract infection (URTI) without prescribing antibiotics. Method: Interventions were developed using a systematic, empirically informed approach in which we: selected theoretical frameworks; identified modifiable behavioural antecedents that predicted GPs intended and actual management of URTI; mapped these target antecedents on to evidence-based behaviour change techniques; and operationalised intervention components in a format suitable for delivery by postal questionnaire. Results: We identified two psychological constructs that predicted GP management of URTI: "Self-efficacy," representing belief in one's capabilities, and "Anticipated consequences," representing beliefs about the consequences of one's actions. Behavioural techniques known to be effective in changing these beliefs were used in the design of two paper-based, interactive interventions. Intervention 1 targeted self-efficacy and required GPs to consider progressively more difficult situations in a "graded task" and to develop an "action plan" of what to do when next presented with one of these situations. Intervention 2 targeted anticipated consequences and required GPs to respond to a "persuasive communication" containing a series of pictures representing the consequences of managing URTI with and without antibiotics. Conclusion: It is feasible to systematically develop theoretically-based interventions to change professional practice. Two interventions were designed that differentially target generalisable constructs predictive of GP management of URTI. Our detailed and scientific rationale for the choice and design of our interventions will provide a basis for understanding any effects identified in their evaluation. Trial registration: Clinicaltrials.gov NCT00376142This study is funded by the European Commission Research Directorate as part of a multi-partner program: Research Based Education and Quality Improvement (ReBEQI): A Framework and tools to develop effective quality improvement programs in European healthcare. (Proposal No: QLRT-2001-00657)

An intervention modelling experiment to change GP's intentions to implement evidence-based practice : using theory-based interventions to promote GP management of upper respiratory tract infection without prescribing antibiotics #2

Background: Psychological theories of behaviour may provide a framework to guide the design of interventions to change professional behaviour. Behaviour change interventions, designed using psychological theory and targeting important motivational beliefs, were experimentally evaluated for effects on the behavioural intention and simulated behaviour of GPs in the management of uncomplicated upper respiratory tract infection (URTI). Methods: The design was a 2 × 2 factorial randomised controlled trial. A postal questionnaire was developed based on three theories of human behaviour: Theory of Planned Behaviour; Social Cognitive Theory and Operant Learning Theory. The beliefs and attitudes of GPs regarding the management of URTI without antibiotics and rates of prescribing on eight patient scenarios were measured at baseline and post-intervention. Two theory-based interventions, a "graded task" with "action planning" and a "persuasive communication", were incorporated into the post-intervention questionnaire. Trial groups were compared using co-variate analyses. Results: Post-intervention questionnaires were returned for 340/397 (86%) GPs who responded to the baseline survey. Each intervention had a significant effect on its targeted behavioural belief: compared to those not receiving the intervention GPs completing Intervention 1 reported stronger self-efficacy scores (Beta = 1.41, 95% CI: 0.64 to 2.25) and GPs completing Intervention 2 had more positive anticipated consequences scores (Beta = 0.98, 95% CI = 0.46 to 1.98). Intervention 2 had a significant effect on intention (Beta = 0.90, 95% CI = 0.41 to 1.38) and simulated behaviour (Beta = 0.47, 95% CI = 0.19 to 0.74). Conclusion: GPs' intended management of URTI was significantly influenced by their confidence in their ability to manage URTI without antibiotics and the consequences they anticipated as a result of doing so. Two targeted behaviour change interventions differentially affected these beliefs. One intervention also significantly enhanced GPs' intentions not to prescribe antibiotics for URTI and resulted in lower rates of prescribing on patient scenarios compared to a control group. The theoretical frameworks utilised provide a scientific rationale for understanding how and why the interventions had these effects, improving the reproducibility and generalisability of these findings and offering a sound basis for an intervention in a "real world" trial. Trial registration: Clinicaltrials.gov NCT00376142This study is funded by the European Commission Research Directorate as part of a multi-partner program: Research Based Education and Quality Improvement (ReBEQI): A Framework and tools to develop effective quality improvement programs in European healthcare. (Proposal No: QLRT-2001-00657)

Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Risky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK. This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care.</p> <p>Methods</p> <p>The trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742) attending their booking appointment with a community midwife (n = 31) in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C). Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120). Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control) or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention). As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention delivery, and retention in the study population, to inform power calculations for a definitive trial. The health-economics component will establish how cost-effectiveness will be assessed, and examine which data on health service resource use should be collected in a main trial. Participants’ views on instruments and procedures will be sought to confirm their acceptability.</p> <p>Discussion</p> <p>The study will produce a full trial protocol with robust sample-size calculations to extend evidence on effectiveness of screening and brief intervention.</p> <p>Trial Registration</p> <p>Current Controlled Trials ISRCTN43218782</p

Effectiveness of psychosocial interventions for reducing parental substance misuse.

BACKGROUND: Parental substance use is a substantial public health and safeguarding concern. There have been a number of trials of interventions relating to substance-using parents that have sought to address this risk factor, with potential outcomes for parent and child. OBJECTIVES: To assess the effectiveness of psychosocial interventions in reducing parental substance use (alcohol and/or illicit drugs, excluding tobacco). SEARCH METHODS: We searched the following databases from their inception to July 2020: the Cochrane Drugs and Alcohol Group Specialised Register; CENTRAL; MEDLINE; Embase; PsycINFO; CINAHL; Applied Social Science (ASSIA); Sociological Abstracts; Social Science Citation Index (SSCI), Scopus, ClinicalTrials.gov, WHO ICTRP, and TRoPHI. We also searched key journals and the reference lists of included papers and contacted authors publishing in the field. SELECTION CRITERIA: We included data from trials of complex psychosocial interventions targeting substance use in parents of children under the age of 21 years. Studies were only included if they had a minimum follow-up period of six months from the start of the intervention and compared psychosocial interventions to comparison conditions. The primary outcome of this review was a reduction in the frequency of parental substance use. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included 22 unique studies with a total of 2274 participants (mean age of parents ranged from 26.3 to 40.9 years), examining 24 experimental interventions. The majority of studies intervened with mothers only (n = 16; 73%). Heroin, cocaine, and alcohol were the most commonly reported substances used by participants. The interventions targeted either parenting only (n = 13; 59%); drug and alcohol use only (n = 5; 23%); or integrated interventions which addressed both (n = 6; 27%). Half of the studies (n = 11; 50%) compared the experimental intervention to usual treatment. Other comparison groups were minimal intervention, attention controls, and alternative intervention. Eight of the included studies reported data relating to our primary outcome at 6- and/or 12-month follow-up and were included in a meta-analysis. We investigated intervention effectiveness separately for alcohol and drugs. Studies were found to be mostly at low or unclear risk for all 'Risk of bias' domains except blinding of participants and personnel and outcome assessment.  We found moderate-quality evidence that psychosocial interventions are probably more effective at reducing the frequency of parental alcohol misuse than comparison conditions at 6-month (mean difference (MD) -0.32, 95% confidence interval (CI) -0.51 to -0.13; 6 studies, 475 participants) and 12-month follow-up (standardised mean difference (SMD) -0.25, 95% CI -0.47 to -0.03; 4 studies, 366 participants). We found a significant reduction in frequency of use at 12 months only (SMD -0.21, 95% CI -0.41 to -0.01; 6 studies, 514 participants, moderate-quality evidence). We examined the effect of the intervention type. We found low-quality evidence that psychosocial interventions targeting substance use only may not reduce the frequency of alcohol (6 months: SMD -0.35, 95% CI -0.86 to 0.16; 2 studies, 89 participants and 12 months: SMD -0.09, 95% CI -0.86 to 0.61; 1 study, 34 participants) or drug use (6 months: SMD 0.01, 95% CI -0.42 to 0.44; 2 studies; 87 participants and 12 months: SMD -0.08, 95% CI -0.81 to 0.65; 1 study, 32 participants). A parenting intervention only, without an adjunctive substance use component, may not reduce frequency of alcohol misuse (6 months: SMD -0.21, 95% CI -0.46 to 0.04, 3 studies; 273 participants, low-quality evidence and 12 months: SMD -0.11, 95% CI -0.64 to 0.41; 2 studies; 219 participants, very low-quality evidence) or frequency of drug use  (6 months: SMD 0.10, 95% CI -0.11 to 0.30; 4 studies; 407 participants, moderate-quality evidence and 12 months: SMD -0.13, 95% CI -0.52 to 0.26; 3 studies; 351 participants, very low-quality evidence). Parents receiving integrated interventions which combined both parenting- and substance use-targeted components may reduce alcohol misuse with a small effect size (6 months: SMD -0.56, 95% CI -0.96 to -0.16 and 12 months: SMD -0.42, 95% CI -0.82 to -0.03; 2 studies, 113 participants) and drug use (6 months: SMD -0.39, 95% CI -0.75 to -0.03 and 12 months: SMD -0.43, 95% CI -0.80 to -0.07; 2 studies, 131 participants). However, this evidence was of low quality. Psychosocial interventions in which the child was present in the sessions were not effective in reducing the frequency of parental alcohol or drug use, whilst interventions that did not involve children in any of the sessions were found to reduce frequency of alcohol misuse (6 months: SMD -0.47, 95% CI -0.76 to -0.18; 3 studies, 202 participants and 12 months: SMD -0.34, 95% CI -0.69 to 0.00; 2 studies, 147 participants) and drug use at 12-month follow-up (SMD -0.34, 95% CI -0.69 to 0.01; 2 studies, 141 participants). The quality of this evidence was low. Interventions appeared to be more often beneficial for fathers than for mothers. We found low- to very low-quality evidence of a reduction in frequency of alcohol misuse for mothers at six months only (SMD -0.27, 95% CI -0.50 to -0.04; 4 studies, 328 participants), whilst in fathers there was a reduction in frequency of alcohol misuse (6 months: SMD -0.43, 95% CI -0.78 to -0.09; 2 studies, 147 participants and 12 months: SMD -0.34, 95% CI -0.69 to 0.00; 2 studies, 147 participants) and drug use (6 months: SMD -0.31, 95% CI -0.66 to 0.04; 2 studies, 141 participants and 12 months: SMD -0.34, 95% CI -0.69 to 0.01; 2 studies, 141 participants). AUTHORS' CONCLUSIONS: We found moderate-quality evidence that psychosocial interventions probably reduce the frequency at which parents use alcohol and drugs. Integrated psychosocial interventions which combine parenting skills interventions with a substance use component may show the most promise. Whilst it appears that mothers may benefit less than fathers from intervention, caution is advised in the interpretation of this evidence, as the interventions provided to mothers alone typically did not address their substance use and other related needs. We found low-quality evidence from few studies that interventions involving children are not beneficial

Differential impact of minimum unit pricing on alcohol consumption between Scottish men and women: controlled interrupted time series analysis.

OBJECTIVE: To assess the immediate impact of the introduction of minimum unit pricing (MUP) in Scotland on alcohol consumption and whether the impact differed by sex, level of alcohol consumption, age, social grade and level of residential deprivation of respondents. DESIGN: Primary controlled interrupted time series analysis and secondary before-and-after analysis of the impact of introducing MUP in Scotland using alcohol consumption data for England as control. SETTING: Data from Kantar Worldpanel’s Alcovision survey, a continuous retrospective online timeline follow-back diary survey of the previous week’s alcohol consumption. PARTICIPANTS: 53 347 women and 53 143 men. INTERVENTIONS: Introduction of a minimum price of 50 pence per UK unit (6.25 pence/g) for the sale of alcohol in Scotland on 1 May 2018. MAIN OUTCOME MEASURES: Number of grams of alcohol consumed per week, in total, in off-trade (eg, at home) and in on-trade (eg, in pubs, restaurants). RESULTS: Primary interrupted time series analyses found that the introduction of MUP was associated with a drop in reported weekly total alcohol consumption of 5.94 g (95% CI 1.29 to 10.60), a drop in off-trade consumption of 3.27 g (95% CI −0.01 to 6.56) and a drop in on-trade consumption of 2.67 g (95% CI −1.48 to 6.82). Associated reductions were larger for women than for men and were greater among heavier drinkers than for lighter drinkers, except for the 5% of heaviest drinking men for whom an associated increase in consumption was found. Secondary before-and-after analyses found that reductions in consumption were greater among older respondents and those living in less deprived areas. The introduction of MUP was not associated with a reduction in consumption among younger men and men living in more deprived areas. CONCLUSIONS: Greater policy attention needs to be addressed to the heaviest drinking men, to younger men and to men who live in more deprived areas

The effectiveness of brief alcohol interventions in primary care settings: A systematic review

Numerous studies have reported that brief interventions delivered in primary care are effective in reducing excessive drinking. However, much of this work has been criticised for being clinically unrepresentative. This review aimed to assess the effectiveness of brief interventions in primary care and determine if outcomes differ between efficacy and effectiveness trials. Approach. A pre-specified search strategy was used to search all relevant electronic databases up to 2006. We also hand-searched the reference lists of key articles and reviews. We included randomised controlled trials (RCT) involving patients in primary care who were not seeking alcohol treatment and who received brief intervention. Two authors independently abstracted data and assessed trial quality. Random effects meta-analyses, subgroup and sensitivity analyses and meta-regression were conducted