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1.  Advance telephone calls ahead of reminder questionnaires increase response rate in non-responders compared to questionnaire reminders only: The RECORD phone trial 
Trials  2014;15:13.
Background
Postal questionnaires are simple and economical for collecting outcome data for randomised controlled trials (RCTs) but are prone to non-response. In the RECORD trial (a large pragmatic publicly funded RCT in UK) non-responders were sent a reminder and another questionnaire at 1 year, of which 40% were returned. In subsequent years we investigated the effect of an advance telephone call to non-responders on responses rate to reminder questionnaires and the next questionnaire 4 months later.
Methods
Non-responders to annual questionnaires were randomised to receive a telephone call from the trial office ahead of the reminder questionnaire in addition to the usual reminder schedule (n = 390) or to a control group that received the usual reminder schedule only (n = 363). The primary outcome was response to the reminder questionnaire within 21 days; secondary outcomes were response to a questionnaire 4 months later; completeness of quality of life instruments; and the number of participants declining further follow-up. Results are presented as odds ratios from a logistic regression intention-to-treat (ITT) analysis and then percentage difference and 95% confidence intervals (CI) for both ITT and average treatment effect on the treated (ATT) analyses.
Results
The proportions that responded were 67.8% (265/390) in the intervention group compared to 62.5% (227/363) in the control group. The ITT estimate was a 5.4% increase (95% CI −1.4 to 12.2). Four months later percentages responding were 51.8% (202) and 42.7% (155). The ITT estimate was a 9.1% increase (95% CI 2.0 to 16.2). In the intervention group 12.3% (48/390) of participants were not telephoned because questionnaires were returned before the scheduled telephone call. ATT estimates adjusting for this were 6.2% (95% CI −1.6 to 14.0) and 10.4% (95% CI 2.2 to 18.5), respectively.
Conclusions
The telephone call resulted in a slight increase in response to the reminder questionnaire, however at 4 months later the proportion in the telephoned group responding was greater. This study suggests that pre-notification telephone calls may only be worthwhile if further questionnaires are to be sent out soon after reminder questionnaires.
Trial registration
Current Clinical Trials ISRCTN51647438
doi:10.1186/1745-6215-15-13
PMCID: PMC3895819  PMID: 24401173
Telephone reminders; Postal questionnaires; Response rates; Average treatment effect on the treated
2.  Explaining clinical behaviors using multiple theoretical models 
Background
In the field of implementation research, there is an increased interest in use of theory when designing implementation research studies involving behavior change. In 2003, we initiated a series of five studies to establish a scientific rationale for interventions to translate research findings into clinical practice by exploring the performance of a number of different, commonly used, overlapping behavioral theories and models. We reflect on the strengths and weaknesses of the methods, the performance of the theories, and consider where these methods sit alongside the range of methods for studying healthcare professional behavior change.
Methods
These were five studies of the theory-based cognitions and clinical behaviors (taking dental radiographs, performing dental restorations, placing fissure sealants, managing upper respiratory tract infections without prescribing antibiotics, managing low back pain without ordering lumbar spine x-rays) of random samples of primary care dentists and physicians. Measures were derived for the explanatory theoretical constructs in the Theory of Planned Behavior (TPB), Social Cognitive Theory (SCT), and Illness Representations specified by the Common Sense Self Regulation Model (CSSRM). We constructed self-report measures of two constructs from Learning Theory (LT), a measure of Implementation Intentions (II), and the Precaution Adoption Process. We collected data on theory-based cognitions (explanatory measures) and two interim outcome measures (stated behavioral intention and simulated behavior) by postal questionnaire survey during the 12-month period to which objective measures of behavior (collected from routine administrative sources) were related. Planned analyses explored the predictive value of theories in explaining variance in intention, behavioral simulation and behavior.
Results
Response rates across the five surveys ranged from 21% to 48%; we achieved the target sample size for three of the five surveys. For the predictor variables, the mean construct scores were above the mid-point on the scale with median values across the five behaviors generally being above four out of seven and the range being from 1.53 to 6.01. Across all of the theories, the highest proportion of the variance explained was always for intention and the lowest was for behavior. The Knowledge-Attitudes-Behavior Model performed poorly across all behaviors and dependent variables; CSSRM also performed poorly. For TPB, SCT, II, and LT across the five behaviors, we predicted median R2 of 25% to 42.6% for intention, 6.2% to 16% for behavioral simulation, and 2.4% to 6.3% for behavior.
Conclusions
We operationalized multiple theories measuring across five behaviors. Continuing challenges that emerge from our work are: better specification of behaviors, better operationalization of theories; how best to appropriately extend the range of theories; further assessment of the value of theories in different settings and groups; exploring the implications of these methods for the management of chronic diseases; and moving to experimental designs to allow an understanding of behavior change.
doi:10.1186/1748-5908-7-99
PMCID: PMC3500222  PMID: 23075284
3.  Using shared goal setting to improve access and equity: a mixed methods study of the Good Goals intervention in children’s occupational therapy 
Background
Access and equity in children’s therapy services may be improved by directing clinicians’ use of resources toward specific goals that are important to patients. A practice-change intervention (titled ‘Good Goals’) was designed to achieve this. This study investigated uptake, adoption, and possible effects of that intervention in children’s occupational therapy services.
Methods
Mixed methods case studies (n = 3 services, including 46 therapists and 558 children) were conducted. The intervention was delivered over 25 weeks through face-to-face training, team workbooks, and ‘tools for change’. Data were collected before, during, and after the intervention on a range of factors using interviews, a focus group, case note analysis, routine data, document analysis, and researchers’ observations.
Results
Factors related to uptake and adoptions were: mode of intervention delivery, competing demands on therapists’ time, and leadership by service manager. Service managers and therapists reported that the intervention: helped therapists establish a shared rationale for clinical decisions; increased clarity in service provision; and improved interactions with families and schools. During the study period, therapists’ behaviours changed: identifying goals, odds ratio 2.4 (95% CI 1.5 to 3.8); agreeing goals, 3.5 (2.4 to 5.1); evaluating progress, 2.0 (1.1 to 3.5). Children’s LoT decreased by two months [95% CI −8 to +4 months] across the services. Cost per therapist trained ranged from £1,003 to £1,277, depending upon service size and therapists’ salary bands.
Conclusions
Good Goals is a promising quality improvement intervention that can be delivered and adopted in practice and may have benefits. Further research is required to evaluate its: (i) impact on patient outcomes, effectiveness, cost-effectiveness, and (ii) transferability to other clinical contexts.
doi:10.1186/1748-5908-7-76
PMCID: PMC3444894  PMID: 22898191
4.  Do incentives, reminders or reduced burden improve healthcare professional response rates in postal questionnaires? two randomised controlled trials 
Background
Healthcare professional response rates to postal questionnaires are declining and this may threaten the validity and generalisability of their findings. Methods to improve response rates do incur costs (resources) and increase the cost of research projects. The aim of these randomised controlled trials (RCTs) was to assess whether 1) incentives, 2) type of reminder and/or 3) reduced response burden improve response rates; and to assess the cost implications of such additional effective interventions.
Methods
Two RCTs were conducted. In RCT A general dental practitioners (dentists) in Scotland were randomised to receive either an incentive; an abridged questionnaire or a full length questionnaire. In RCT B non-responders to a postal questionnaire sent to general medical practitioners (GPs) in the UK were firstly randomised to receive a second full length questionnaire as a reminder or a postcard reminder. Continued non-responders from RCT B were then randomised within their first randomisation to receive a third full length or an abridged questionnaire reminder. The cost-effectiveness of interventions that effectively increased response rates was assessed as a secondary outcome.
Results
There was no evidence that an incentive (52% versus 43%, Risk Difference (RD) -8.8 (95%CI −22.5, 4.8); or abridged questionnaire (46% versus 43%, RD −2.9 (95%CI −16.5, 10.7); statistically significantly improved dentist response rates compared to a full length questionnaire in RCT A. In RCT B there was no evidence that a full questionnaire reminder statistically significantly improved response rates compared to a postcard reminder (10.4% versus 7.3%, RD 3 (95%CI −0.1, 6.8). At a second reminder stage, GPs sent the abridged questionnaire responded more often (14.8% versus 7.2%, RD −7.7 (95%CI −12.8, -2.6). GPs who received a postcard reminder followed by an abridged questionnaire were most likely to respond (19.8% versus 6.3%, RD 8.1%, and 9.1% for full/postcard/full, three full or full/full/abridged questionnaire respectively). An abridged questionnaire containing fewer questions following a postcard reminder was the only cost-effective strategy for increasing the response rate (£15.99 per response).
Conclusions
When expecting or facing a low response rate to postal questionnaires, researchers should carefully identify the most efficient way to boost their response rate. In these studies, an abridged questionnaire containing fewer questions following a postcard reminder was the only cost-effective strategy. An increase in response rates may be explained by a combination of the number and type of contacts. Increasing the sampling frame may be more cost-effective than interventions to prompt non-responders. However, this may not strengthen the validity and generalisability of the survey findings and affect the representativeness of the sample.
doi:10.1186/1472-6963-12-250
PMCID: PMC3508866  PMID: 22891875
5.  Process evaluation for the FEeding Support Team (FEST) randomised controlled feasibility trial of proactive and reactive telephone support for breastfeeding women living in disadvantaged areas 
BMJ Open  2012;2(2):e001039.
Objective
To assess the feasibility, acceptability and fidelity of a feeding team intervention with an embedded randomised controlled trial of team-initiated (proactive) and woman-initiated (reactive) telephone support after hospital discharge.
Design
Participatory approach to the design and implementation of a pilot trial embedded within a before-and-after study, with mixed-method process evaluation.
Setting
A postnatal ward in Scotland.
Sample
Women initiating breast feeding and living in disadvantaged areas.
Methods
Quantitative data: telephone call log and workload diaries. Qualitative data: interviews with women (n=40) with follow-up (n=11) and staff (n=17); ward observations 2 weeks before and after the intervention; recorded telephone calls (n=16) and steering group meetings (n=9); trial case notes (n=69); open question in a telephone interview (n=372). The Framework approach to analysis was applied to mixed-method data.
Main outcome measures
Quantitative: telephone call characteristics (number, frequency, duration); workload activity. Qualitative: experiences and perspectives of women and staff.
Results
A median of eight proactive calls per woman (n=35) with a median duration of 5 min occurred in the 14 days following hospital discharge. Only one of 34 control women initiated a call to the feeding team, with women undervaluing their own needs compared to others, and breast feeding as a reason to call. Proactive calls providing continuity of care increased women's confidence and were highly valued. Data demonstrated intervention fidelity for woman-centred care; however, observing an entire breast feed was not well implemented due to short hospital stays, ward routines and staff–team–woman communication issues. Staff pragmatically recognised that dedicated feeding teams help meet women's breastfeeding support needs in the context of overstretched and variable postnatal services.
Conclusions
Implementing and integrating the FEeding Support Team (FEST) trial within routine postnatal care was feasible and acceptable to women and staff from a research and practice perspective and shows promise for addressing health inequalities.
Trial registration
ISRCTN27207603. The study protocol and final report is available on request.
Article summary
Article focus
To use a participatory approach to design, deliver and implement a feeding support team intervention integrated into routine postnatal ward care and to deliver a pilot randomised controlled trial (RCT) of proactive and reactive telephone support for breast feeding for up to 14 days after hospital discharge for women living in more disadvantaged areas.
To use a mixed qualitative and quantitative methods process evaluation to assess the study acceptability, feasibility and intervention fidelity from the perspectives of women and National Health Service staff.
To inform the design of a future definitive RCT.
Key messages
Women living in disadvantaged areas are unlikely to initiate calls for help with breast feeding and proactive telephone calls may help to counteract the inverse care law.
Women undervalue both breast feeding and their own needs compared with the needs of others as a reason to ask for help in the context of overstretched maternity services.
A caring, reassuring woman-centred communication style with continuity of care from hospital to home was valued and increased women's confidence.
Strengths and limitations of this study
The participatory approach embedding a rigorous RCT within a before-and-after cohort study with mixed-methods data to evaluate implementation processes and costs are strengths that will enable us to design a feasible and acceptable definitive trial.
The contribution of the personal characteristics and skills of the feeding team to the intervention was important and may be challenging to replicate.
The low number of women who reported having an entire breast feed observed is a limitation and warrants further investigation.
More research is required before feeding teams and proactive calls are widely implemented as there are likely to be unintended consequences to such an organisational change in postnatal care.
doi:10.1136/bmjopen-2012-001039
PMCID: PMC3341595  PMID: 22535794
6.  The FEeding Support Team (FEST) randomised, controlled feasibility trial of proactive and reactive telephone support for breastfeeding women living in disadvantaged areas 
BMJ Open  2012;2(2):e000652.
Objective
To assess the feasibility of implementing a dedicated feeding support team on a postnatal ward and pilot the potential effectiveness and cost-effectiveness of team (proactive) and woman-initiated (reactive) telephone support after discharge.
Design
Randomised controlled trial embedded within a before-and-after study. Participatory approach and mixed-method process evaluation.
Setting
A postnatal ward in Scotland.
Sample
Women living in disadvantaged areas initiating breast feeding.
Methods
Eligible women were recruited to a before-and-after intervention study, a proportion of whom were independently randomised after hospital discharge to intervention: daily proactive and reactive telephone calls for ≤14 days or control: reactive telephone calls ≤ day 14. Intention-to-treat analysis compared the randomised groups on cases with complete outcomes at follow-up.
Main outcome measures
Primary outcome: any breast feeding at 6–8 weeks assessed by a telephone call from a researcher blind to group allocation. Secondary outcomes: exclusive breast feeding, satisfaction with care, NHS costs and cost per additional woman breast feeding.
Results
There was no difference in feeding outcomes for women initiating breast feeding before the intervention (n=413) and after (n=388). 69 women were randomised to telephone support: 35 intervention (32 complete cases) and 34 control (26 complete cases). 22 intervention women compared with 12 control women were giving their baby some breast milk (RR 1.49, 95% CI 0.92 to 2.40) and 17 intervention women compared with eight control women were exclusively breast feeding (RR 1.73, 95% CI 0.88 to 3.37) at 6–8 weeks after birth. The incremental cost of providing proactive calls was £87 per additional woman breast feeding and £91 per additional woman exclusively breast feeding at 6–8 weeks; costs were sensitive to service organisation.
Conclusions
Proactive telephone care delivered by a dedicated feeding team shows promise as a cost-effective intervention for improving breastfeeding outcomes. Integrating the FEeding Support Team (FEST) intervention into routine postnatal care was feasible.
Trial registration number
ISRCTN27207603. The study protocol and final report are available on request.
Article summary
Article focus
To pilot the potential effectiveness and cost-effectiveness of continuing proactive and reactive telephone support for breast feeding for up to 14 days after hospital discharge for women living in more disadvantaged areas.
To assess the feasibility of implementing a dedicated feeding team on a postnatal ward.
To design an effective health service intervention for infant feeding by re-organising how routine care is provided to inform a larger programme of research.
Key messages
Proactive telephone care delivered by a dedicated feeding team shows promise for increasing breastfeeding rates 6–8 weeks after birth.
Only having a dedicated feeding team on a postnatal ward did not appear to make any difference to feeding outcomes at 6–8 weeks after birth.
We have demonstrated the feasibility of (1) implementing the FEeding Support Team intervention as part of routine postnatal care and (2) the recruitment and data collection processes for a proposed definitive trial.
Strengths and limitations of this study
Using a participatory approach and embedding a rigorous randomised control trial within a before-and-after cohort study with mixed methods data to evaluate costs are strengths that will enable us to design a definitive trial.
It is likely that the effect sizes are overestimated as the sample size was small and no sample size calculation was performed prior to the study.
Our sample included women requiring longer hospital stays due to birth complications.
The reactive call service was only free to those who had the same mobile phone network provider.
The incremental cost-effectiveness ratios presented represent the most favourable set of assumptions for proactive telephone support and are sensitive to how the service is organised.
doi:10.1136/bmjopen-2011-000652
PMCID: PMC3341594  PMID: 22535790
7.  Rationing of total knee replacement: a cost-effectiveness analysis on a large trial data set 
BMJ Open  2012;2(1):e000332.
Objectives
Many UK primary care trusts have recently introduced eligibility criteria restricting total knee replacement (TKR) to patients with low pre-operative Oxford Knee Scores (OKS) to cut expenditure. We evaluate these criteria by assessing the cost-effectiveness of TKR compared with no knee replacement for patients with different baseline characteristics from an NHS perspective.
Design
The cost-effectiveness of TKR in different patient subgroups was assessed using regression analyses of patient-level data from the Knee Arthroplasty Trial, a large, pragmatic randomised trial comparing knee prostheses.
Setting
34 UK hospitals.
Participants
2131 osteoarthritis patients undergoing TKR.
Interventions and outcome measures
Costs and quality-adjusted life years (QALYs) observed in the Knee Arthroplasty Trial within 5 years of TKR were compared with conservative assumptions about the costs and outcomes that would have been accrued had TKR not been performed.
Results
On average, primary TKR and 5 years of subsequent care cost £7458 per patient (SD: £4058), and patients gained an average of 1.33 (SD: 1.43) QALYs. As a result, TKR cost £5623/QALY gained. Although costs and health outcomes varied with age and sex, TKR cost <£20 000/QALY gained for patients with American Society of Anaesthesiologists grades 1–2 who had baseline OKS <40 and for American Society of Anaesthesiologists grade 3 patients with OKS <35, even with highly conservative assumptions about costs and outcomes without TKR. Body mass index had no significant effect on costs or outcomes. Restricting TKR to patients with pre-operative OKS <27 would inappropriately deny a highly cost-effective treatment to >10 000 patients annually.
Conclusions
TKR is highly cost-effective for most current patients if the NHS is willing to pay £20 000–£30 000/QALY gained. At least 97% of TKR patients in England have more severe symptoms than the thresholds we have identified, suggesting that further rationing by OKS is probably unjustified.
Trial registration number
ISRCTN 45837371.
Article summary
Article focus
We assess the cost-effectiveness of total knee replacement (TKR) compared with no knee replacement for patients with different baseline characteristics from a NHS perspective.
In particular, we assess the appropriateness of eligibility criteria recently introduced by many UK primary care trusts, which restrict TKR to patients with low (ie, poor) pre-operative Oxford Knee Scores (OKS) to cut expenditure.
Key messages
We find TKR to be highly cost-effective, costing £5623 per quality-adjusted life year gained for the average patient.
TKR costs <£20 000 per quality-adjusted life year gained for healthy patients with OKS of <40 or <35 for patients who have other conditions restricting their daily activities.
We find no evidence to support the criteria for restricting access to TKR that have been proposed by some primary care trusts and calculate that restricting TKR to those patients with pre-operative OKS of 26 or less would deny a highly cost-effective treatment to >10 000 patients/year.
Strengths and limitations of this study
This is the first study assessing how the cost-effectiveness of TKR varies with OKS and the first assessing the clinical/economic implications of the newly introduced rationing criteria.
Analyses are based on patient-level data from a large pragmatic trial with detailed prospective collection of utilities, baseline characteristics and all major knee-related NHS resource use, including revisions and ambulatory care.
Our study makes several highly conservative assumptions: in particular, assuming that patients would have accrued no knee-related costs and remained at baseline utility without TKR. Furthermore, the Knee Arthroplasty Trial sample included only 37 patients with pre-operative OKS >35. As result, TKR may be also cost-effective for some patients with OKS above 39.
doi:10.1136/bmjopen-2011-000332
PMCID: PMC3269047  PMID: 22290396
8.  Clustering in surgical trials - database of intracluster correlations 
Trials  2012;13:2.
Background
Randomised trials evaluation of surgical interventions are often designed and analysed as if the outcome of individual patients is independent of the surgeon providing the intervention. There is reason to expect outcomes for patients treated by the same surgeon tend to be more similar than those under the care of another surgeon due to previous experience, individual practice, training, and infrastructure. Such a phenomenon is referred to as the clustering effect and potentially impacts on the design and analysis adopted and thereby the required sample size. The aim of this work was to inform trial design by quantifying clustering effects (at both centre and surgeon level) for various outcomes using a database of surgical trials.
Methods
Intracluster correlation coefficients (ICCs) were calculated for outcomes from a set of 10 multicentre surgical trials for a range of outcomes and different time points for clustering at both the centre and surgeon level.
Results
ICCs were calculated for 198 outcomes across the 10 trials at both centre and surgeon cluster levels. The number of cases varied from 138 to 1370 across the trials. The median (range) average cluster size was 32 (9 to 51) and 6 (3 to 30) for centre and surgeon levels respectively. ICC estimates varied substantially between outcome type though uncertainty around individual ICC estimates was substantial, which was reflected in generally wide confidence intervals.
Conclusions
This database of surgical trials provides trialists with valuable information on how to design surgical trials. Our data suggests clustering of outcome is more of an issue than has been previously acknowledged. We anticipate that over time the addition of ICCs from further surgical trial datasets to our database will further inform the design of surgical trials.
doi:10.1186/1745-6215-13-2
PMCID: PMC3311136  PMID: 22217216
Surgery; ICC; multicentre; clustering
11.  Surveillance mammography for detecting ipsilateral breast tumour recurrence and metachronous contralateral breast cancer: a systematic review 
European Radiology  2011;21(12):2484-2491.
Objectives
To determine the diagnostic accuracy of surveillance mammography for detecting ipsilateral breast tumour recurrence and metachronous contralateral breast cancer in women previously treated for primary breast cancer.
Methods
A systematic review of surveillance mammography compared with ultrasound, magnetic resonance imaging (MRI), specialist-led clinical examination or unstructured primary care follow-up, using histopathological assessment for test positives and follow-up for test negatives as the reference standard.
Results
Nine studies met our inclusion criteria. Variations in study comparisons precluded meta-analysis. For routine ipsilateral breast tumour detection, surveillance mammography sensitivity ranged from 64–67% and specificity ranged from 85–97%. For MRI, sensitivity ranged from 86–100% and specificity was 93%. For non-routine ipsilateral breast tumour detection, sensitivity and specificity for surveillance mammography ranged from 50–83% and 57–75% and for MRI 93–100% and 88–96%. For routine metachronous contralateral breast cancer detection, one study reported sensitivity of 67% and specificity of 50% for both surveillance mammography and MRI.
Conclusion
Although mammography is associated with high sensitivity and specificity, MRI is the most accurate test for detecting ipsilateral breast tumour recurrence and metachronous contralateral breast cancer in women previously treated for primary breast cancer. Results should be interpreted with caution because of the limited evidence base.
Key Points
• Surveillance mammography is associated with high sensitivity and specificity
• Findings suggest that MRI is the most accurate test for detecting further breast cancer
• Robust conclusions cannot be made due to the limited evidence base
• Further research comparing surveillance mammography and other diagnostic tests is required
doi:10.1007/s00330-011-2226-z
PMCID: PMC3217137  PMID: 21833567
Mammography; Surveillance; Diagnostic accuracy; Neoplasm recurrence, local; Neoplasm, second primary
12.  Applying psychological theories to evidence-based clinical practice: identifying factors predictive of lumbar spine x-ray for low back pain in UK primary care practice 
Background
Psychological models predict behaviour in a wide range of settings. The aim of this study was to explore the usefulness of a range of psychological models to predict the health professional behaviour 'referral for lumbar spine x-ray in patients presenting with low back pain' by UK primary care physicians.
Methods
Psychological measures were collected by postal questionnaire survey from a random sample of primary care physicians in Scotland and north England. The outcome measures were clinical behaviour (referral rates for lumbar spine x-rays), behavioural simulation (lumbar spine x-ray referral decisions based upon scenarios), and behavioural intention (general intention to refer for lumbar spine x-rays in patients with low back pain). Explanatory variables were the constructs within the Theory of Planned Behaviour (TPB), Social Cognitive Theory (SCT), Common Sense Self-Regulation Model (CS-SRM), Operant Learning Theory (OLT), Implementation Intention (II), Weinstein's Stage Model termed the Precaution Adoption Process (PAP), and knowledge. For each of the outcome measures, a generalised linear model was used to examine the predictive value of each theory individually. Linear regression was used for the intention and simulation outcomes, and negative binomial regression was used for the behaviour outcome. Following this 'theory level' analysis, a 'cross-theoretical construct' analysis was conducted to investigate the combined predictive value of all individual constructs across theories.
Results
Constructs from TPB, SCT, CS-SRM, and OLT predicted behaviour; however, the theoretical models did not fit the data well. When predicting behavioural simulation, the proportion of variance explained by individual theories was TPB 11.6%, SCT 12.1%, OLT 8.1%, and II 1.5% of the variance, and in the cross-theory analysis constructs from TPB, CS-SRM and II explained 16.5% of the variance in simulated behaviours. When predicting intention, the proportion of variance explained by individual theories was TPB 25.0%, SCT 21.5%, CS-SRM 11.3%, OLT 26.3%, PAP 2.6%, and knowledge 2.3%, and in the cross-theory analysis constructs from TPB, SCT, CS-SRM, and OLT explained 33.5% variance in intention. Together these results suggest that physicians' beliefs about consequences and beliefs about capabilities are likely determinants of lumbar spine x-ray referrals.
Conclusions
The study provides evidence that taking a theory-based approach enables the creation of a replicable methodology for identifying factors that predict clinical behaviour. However, a number of conceptual and methodological challenges remain.
doi:10.1186/1748-5908-6-55
PMCID: PMC3125229  PMID: 21619689
13.  Developing and evaluating interventions to reduce inappropriate prescribing by general practitioners of antibiotics for upper respiratory tract infections: A randomised controlled trial to compare paper-based and web-based modelling experiments 
Background
Much implementation research is focused on full-scale trials with little evidence of preceding modelling work. The Medical Research Council Framework for developing and evaluating complex interventions has argued for more and better theoretical and exploratory work prior to a trial as a means of improving intervention development. Intervention modelling experiments (IMEs) are a way of exploring and refining an intervention before moving to a full-scale trial. They do this by delivering key elements of the intervention in a simulation that approximates clinical practice by, for example, presenting general practitioners (GPs) with a clinical scenario about making a treatment decision.
Methods
The current proposal will run a full, web-based IME involving 250 GPs that will advance the methodology of IMEs by directly comparing results with an earlier paper-based IME. Moreover, the web-based IME will evaluate an intervention that can be put into a full-scale trial that aims to reduce antibiotic prescribing for upper respiratory tract infections in primary care. The study will also include a trial of email versus postal invitations to participate.
Discussion
More effective behaviour change interventions are needed and this study will develop one such intervention and a system to model and test future interventions. This system will be applicable to any situation in the National Health Service where behaviour needs to be modified, including interventions aimed directly at the public.
Trial registration
ClinicalTrials (NCT): NCT01206738
doi:10.1186/1748-5908-6-16
PMCID: PMC3058065  PMID: 21371323
14.  Clinicians' caseload management behaviours as explanatory factors in patients' length of time on caseloads: a predictive multilevel study in paediatric community occupational therapy 
Background
Long waiting times and large caseloads are a challenge to children's therapy services internationally. Research in hospital-based healthcare indicates that waiting times are a function of throughput, and that length of care episode is related to clinicians' caseload management behaviour (i.e. actions at assessment, treatment, post-treatment, and discharge). There have been few attempts to study this in community health services. The present study investigated whether community occupational therapists' behaviour predicts children's length of time (LoT) on caseloads.
Methods
Retrospective survey of case notes of children recently discharged from occupational therapy services. Using cluster random sampling, case notes were drawn from therapy records in six NHSScotland Health Boards. Data about therapists' behaviours of assessing, treating, reviewing and discharging, together with child characteristics, were used to construct regression models of factors related to LoT.
Results
Twenty-six therapists [median(IQR) time in paediatrics 8(6-13) years] and 154 of their cases [mean(SD) age 7(3) years; median(IQR) LoT 10(3-21)] were included. A multi-level model, adjusting for clustering, for therapists' actions of communicating assessment outcomes to parents, providing treatment, and placing the child on review, and for a diagnosis of cerebral palsy, explained 44% of variation in LoT.
Conclusions
Occupational therapists' caseload management behaviours are associated with children's LoT on caseloads. Further research is required to investigate the direction of relationships between therapists' behaviours and LoT; and the relationships between contextual factors, therapists' caseload management behaviours and LoT. Further exploration of therapists' beliefs about caseload management could also be useful in identifying possible factors contributing to variation between therapists.
doi:10.1186/1472-6963-10-249
PMCID: PMC2936379  PMID: 20731865
15.  Effect of calcium supplements on risk of myocardial infarction and cardiovascular events: meta-analysis 
Objective To investigate whether calcium supplements increase the risk of cardiovascular events.
Design Patient level and trial level meta-analyses.
Data sources Medline, Embase, and Cochrane Central Register of Controlled Trials (1966-March 2010), reference lists of meta-analyses of calcium supplements, and two clinical trial registries. Initial searches were carried out in November 2007, with electronic database searches repeated in March 2010.
Study selection Eligible studies were randomised, placebo controlled trials of calcium supplements (≥500 mg/day), with 100 or more participants of mean age more than 40 years and study duration more than one year. The lead authors of eligible trials supplied data. Cardiovascular outcomes were obtained from self reports, hospital admissions, and death certificates.
Results 15 trials were eligible for inclusion, five with patient level data (8151 participants, median follow-up 3.6 years, interquartile range 2.7-4.3 years) and 11 with trial level data (11 921 participants, mean duration 4.0 years). In the five studies contributing patient level data, 143 people allocated to calcium had a myocardial infarction compared with 111 allocated to placebo (hazard ratio 1.31, 95% confidence interval 1.02 to 1.67, P=0.035). Non-significant increases occurred in the incidence of stroke (1.20, 0.96 to 1.50, P=0.11), the composite end point of myocardial infarction, stroke, or sudden death (1.18, 1.00 to 1.39, P=0.057), and death (1.09, 0.96 to 1.23, P=0.18). The meta-analysis of trial level data showed similar results: 296 people had a myocardial infarction (166 allocated to calcium, 130 to placebo), with an increased incidence of myocardial infarction in those allocated to calcium (pooled relative risk 1.27, 95% confidence interval 1.01 to 1.59, P=0.038).
Conclusions Calcium supplements (without coadministered vitamin D) are associated with an increased risk of myocardial infarction. As calcium supplements are widely used these modest increases in risk of cardiovascular disease might translate into a large burden of disease in the population. A reassessment of the role of calcium supplements in the management of osteoporosis is warranted.
doi:10.1136/bmj.c3691
PMCID: PMC2912459  PMID: 20671013
16.  Applying psychological theories to evidence-based clinical practice: identifying factors predictive of placing preventive fissure sealants 
Background
Psychological models are used to understand and predict behaviour in a wide range of settings, but have not been consistently applied to health professional behaviours, and the contribution of differing theories is not clear. This study explored the usefulness of a range of models to predict an evidence-based behaviour -- the placing of fissure sealants.
Methods
Measures were collected by postal questionnaire from a random sample of general dental practitioners (GDPs) in Scotland. Outcomes were behavioural simulation (scenario decision-making), and behavioural intention. Predictor variables were from the Theory of Planned Behaviour (TPB), Social Cognitive Theory (SCT), Common Sense Self-regulation Model (CS-SRM), Operant Learning Theory (OLT), Implementation Intention (II), Stage Model, and knowledge (a non-theoretical construct). Multiple regression analysis was used to examine the predictive value of each theoretical model individually. Significant constructs from all theories were then entered into a 'cross theory' stepwise regression analysis to investigate their combined predictive value
Results
Behavioural simulation - theory level variance explained was: TPB 31%; SCT 29%; II 7%; OLT 30%. Neither CS-SRM nor stage explained significant variance. In the cross theory analysis, habit (OLT), timeline acute (CS-SRM), and outcome expectancy (SCT) entered the equation, together explaining 38% of the variance. Behavioural intention - theory level variance explained was: TPB 30%; SCT 24%; OLT 58%, CS-SRM 27%. GDPs in the action stage had significantly higher intention to place fissure sealants. In the cross theory analysis, habit (OLT) and attitude (TPB) entered the equation, together explaining 68% of the variance in intention.
Summary
The study provides evidence that psychological models can be useful in understanding and predicting clinical behaviour. Taking a theory-based approach enables the creation of a replicable methodology for identifying factors that may predict clinical behaviour and so provide possible targets for knowledge translation interventions. Results suggest that more evidence-based behaviour may be achieved by influencing beliefs about the positive outcomes of placing fissure sealants and building a habit of placing them as part of patient management. However a number of conceptual and methodological challenges remain.
doi:10.1186/1748-5908-5-25
PMCID: PMC2864198  PMID: 20377849
17.  Quality of life in the five years after intensive care: a cohort study 
Critical Care  2010;14(1):R6.
Introduction
Data on quality of life beyond 2 years after intensive care discharge are limited and we aimed to explore this area further. Our objective was to quantify quality of life and health utilities in the 5 years after intensive care discharge.
Methods
A prospective longitudinal cohort study in a University Hospital in the UK. Quality of life was assessed from the period before ICU admission until 5 years and quality adjusted life years calculated.
Results
300 level 3 intensive care patients of median age 60.5 years and median length of stay 6.7 days, were recruited. Physical quality of life fell to 3 months (P = 0.003), rose back to pre-morbid levels at 12 months then fell again from 2.5 to 5 years after intensive care (P = 0.002). Mean physical scores were below the population norm at all time points but the mean mental scores after 6 months were similar to those population norms. The utility value measured using the EuroQOL-5D quality of life assessment tool (EQ-5D) at 5 years was 0.677. During the five years after intensive care unit, the cumulative quality adjusted life years were significantly lower than that expected for the general population (P < 0.001).
Conclusions
Intensive care unit admission is associated with a high mortality, a poor physical quality of life and a low quality adjusted life years gained compared to the general population for 5 years after discharge. In this group, critical illness associated with ICU admission should be treated as a life time diagnosis with associated excess mortality, morbidity and the requirement for ongoing health care support.
doi:10.1186/cc8848
PMCID: PMC2875518  PMID: 20089197
18.  The accuracy of accredited glaucoma optometrists in the diagnosis and treatment recommendation for glaucoma 
The British Journal of Ophthalmology  2007;91(12):1639-1643.
Aim
To compare the diagnostic performance of accredited glaucoma optometrists (AGO) for both the diagnosis of glaucoma and the decision to treat with that of routine hospital eye care, against a reference standard of expert opinion (a consultant ophthalmologist with a special interest in glaucoma).
Methods
A directly comparative, masked, performance study was undertaken in Grampian, Scotland. Of 165 people invited to participate, 100 (61%) were examined. People suspected of having glaucoma underwent, within one month, a full ophthalmic assessment in both a newly established community optometry led glaucoma management scheme and a consultant led hospital eye service.
Results
Agreement between the AGO and the consultant ophthalmologist in diagnosing glaucoma was substantial (89%; κ = 0.703, SE = 0.083). Agreement over the need for treatment was also substantial (88%; κ = 0.716, SE = 0.076). The agreement between the trainee ophthalmologists and the consultant ophthalmologist in the diagnosis of glaucoma and treatment recommendation was moderate (83%, κ = 0.541, SE = 0.098, SE = 0.98; and 81%, κ = 0.553, SE = 0.90, respectively). The diagnostic accuracy of the optometrists in detecting glaucoma in this population was high for specificity (0.93 (95% confidence interval, 0.85 to 0.97)) but lower for sensitivity (0.76 (0.57 to 0.89)). Performance was similar when accuracy was assessed for treatment recommendation (sensitivity 0.73 (0.57 to 0.85); specificity 0.96 (0.88 to 0.99)). The differences in sensitivity and specificity between AGO and junior ophthalmologist were not statistically significant.
Conclusions
Community optometrists trained in glaucoma provided satisfactory decisions regarding diagnosis and initiation of treatment for glaucoma. With such additional training in glaucoma, optometrists are at least as accurate as junior ophthalmologists but some cases of glaucoma are missed.
doi:10.1136/bjo.2007.119628
PMCID: PMC2095552  PMID: 17537783
glaucoma; optometry; ophthalmology; diagnosis
19.  A review of RCTs in four medical journals to assess the use of imputation to overcome missing data in quality of life outcomes 
Trials  2008;9:51.
Background
Randomised controlled trials (RCTs) are perceived as the gold-standard method for evaluating healthcare interventions, and increasingly include quality of life (QoL) measures. The observed results are susceptible to bias if a substantial proportion of outcome data are missing. The review aimed to determine whether imputation was used to deal with missing QoL outcomes.
Methods
A random selection of 285 RCTs published during 2005/6 in the British Medical Journal, Lancet, New England Journal of Medicine and Journal of American Medical Association were identified.
Results
QoL outcomes were reported in 61 (21%) trials. Six (10%) reported having no missing data, 20 (33%) reported ≤ 10% missing, eleven (18%) 11%–20% missing, and eleven (18%) reported >20% missing. Missingness was unclear in 13 (21%). Missing data were imputed in 19 (31%) of the 61 trials. Imputation was part of the primary analysis in 13 trials, but a sensitivity analysis in six. Last value carried forward was used in 12 trials and multiple imputation in two. Following imputation, the most common analysis method was analysis of covariance (10 trials).
Conclusion
The majority of studies did not impute missing data and carried out a complete-case analysis. For those studies that did impute missing data, researchers tended to prefer simpler methods of imputation, despite more sophisticated methods being available.
doi:10.1186/1745-6215-9-51
PMCID: PMC3225816  PMID: 18694492
20.  Alternative approaches to endoscopic ablation for benign enlargement of the prostate: systematic review of randomised controlled trials 
BMJ : British Medical Journal  2008;337(7660):36-39.
Objective To compare the effectiveness and risk profile of newer methods for endoscopic ablation of the prostate against the current standard of transurethral resection.
Design Systematic review and meta-analysis.
Data sources Electronic and paper records in subject area up to March 2006.
Review methods We searched for randomised controlled trials of endoscopic ablative interventions that included transurethral resection of prostate as one of the treatment arms. Two reviewers independently extracted data and assessed quality. Meta-analyses of prespecified outcomes were done using fixed and random effects models and reported using relative risk or weighted mean difference.
Results We identified 45 randomised controlled trials meeting the inclusion criteria and reporting on 3970 participants. The reports were of moderate to poor quality, with small sample sizes. None of the newer technologies resulted in significantly greater improvement in symptoms than transurethral resection at 12 months, although a trend suggested a better outcome with holmium laser enucleation (random effects weighted mean difference −0.82, 95% confidence interval 1.76 to 0.12) and worse outcome with laser vaporisation (1.49, −0.40 to 3.39). Improvements in secondary measures, such as peak urine flow rate, were consistent with change in symptoms. Blood transfusion rates were higher for transurethral resection than for the newer methods (4.8% v 0.7%) and men undergoing laser vaporisation or diathermy vaporisation were more likely to experience urinary retention (6.7% v 2.3% and 3.6% v 1.1%). Hospital stay was up to one day shorter for the newer technologies.
Conclusions Although men undergoing more modern methods of removing benign prostatic enlargement have similar outcomes to standard transurethral resection of prostate along with fewer requirements for blood transfusion and shorter hospital stay, the quality of current evidence is poor. The lack of any clearly more effective procedure suggests that transurethral resection should remain the standard approach.
doi:10.1136/bmj.39575.517674.BE
PMCID: PMC2443595  PMID: 18595932
21.  Protocol for stage 2 of the GaP study (genetic testing acceptability for Paget's disease of bone): A questionnaire study to investigate whether relatives of people with Paget's disease would accept genetic testing and preventive treatment if they were available 
Background
Paget's disease of bone (PDB) disrupts normal bone architecture and causes pain, deformity, deafness, osteoarthritis, and fractures. Genetic factors play a role in PDB and genetic tests are now conducted for research purposes. It is thus timely to investigate the potential for a clinical programme of genetic testing and preventative treatment for people who have a family history of PDB. This study examines the beliefs of relatives of people with PDB. It focuses particularly on illness and treatment representations as predictors of the acceptability and uptake of potential clinical programmes. Illness representations are examined using Leventhal's Common Sense Self-Regulation Model while cognitions about treatment behaviours (acceptance of testing and treatment uptake) are conceptualised within the Theory of Planned Behaviour.
Methods/Design
A postal questionnaire of non-affected relatives of people with Paget's disease. The sample will include relatives of Paget's patients with a family history of Paget's disease and relatives of Paget's patients without a family history of Paget's disease. The questionnaire will explore whether a range of factors relate to acceptability of a programme of genetic testing and preventive treatment in relatives of Paget's disease sufferers. The questionnaire will include several measures: illness representations (as measured by the Brief Illness Perceptions Questionnaire); treatment representations (as measured by Theory of Planned Behaviour-based question items, informed by a prior interview elicitation study); descriptive and demographic details; and questions exploring family environment and beliefs of other important people.
Data will also be collected from family members who have been diagnosed with Paget's disease to describe the disease presentation and its distribution within a family.
Discussion
The answers to these measures will inform the feasibility of a programme of genetic testing and preventive treatment for individuals who are at a high risk of developing Paget's disease because they carry an appropriate genetic mutation. They will also contribute to theoretical and empirical approaches to predicting diagnostic and treatment behaviours from the combined theoretical models.
doi:10.1186/1472-6963-8-116
PMCID: PMC2442429  PMID: 18510762
22.  Applying psychological theories to evidence-based clinical practice: Identifying factors predictive of managing upper respiratory tract infections without antibiotics 
Background
Psychological models can be used to understand and predict behaviour in a wide range of settings. However, they have not been consistently applied to health professional behaviours, and the contribution of differing theories is not clear. The aim of this study was to explore the usefulness of a range of psychological theories to predict health professional behaviour relating to management of upper respiratory tract infections (URTIs) without antibiotics.
Methods
Psychological measures were collected by postal questionnaire survey from a random sample of general practitioners (GPs) in Scotland. The outcome measures were clinical behaviour (using antibiotic prescription rates as a proxy indicator), behavioural simulation (scenario-based decisions to managing URTI with or without antibiotics) and behavioural intention (general intention to managing URTI without antibiotics). Explanatory variables were the constructs within the following theories: Theory of Planned Behaviour (TPB), Social Cognitive Theory (SCT), Common Sense Self-Regulation Model (CS-SRM), Operant Learning Theory (OLT), Implementation Intention (II), Stage Model (SM), and knowledge (a non-theoretical construct). For each outcome measure, multiple regression analysis was used to examine the predictive value of each theoretical model individually. Following this 'theory level' analysis, a 'cross theory' analysis was conducted to investigate the combined predictive value of all significant individual constructs across theories.
Results
All theories were tested, but only significant results are presented. When predicting behaviour, at the theory level, OLT explained 6% of the variance and, in a cross theory analysis, OLT 'evidence of habitual behaviour' also explained 6%. When predicting behavioural simulation, at the theory level, the proportion of variance explained was: TPB, 31%; SCT, 26%; II, 6%; OLT, 24%. GPs who reported having already decided to change their management to try to avoid the use of antibiotics made significantly fewer scenario-based decisions to prescribe. In the cross theory analysis, perceived behavioural control (TPB), evidence of habitual behaviour (OLT), CS-SRM cause (chance/bad luck), and intention entered the equation, together explaining 36% of the variance. When predicting intention, at the theory level, the proportion of variance explained was: TPB, 30%; SCT, 29%; CS-SRM 27%; OLT, 43%. GPs who reported that they had already decided to change their management to try to avoid the use of antibiotics had a significantly higher intention to manage URTIs without prescribing antibiotics. In the cross theory analysis, OLT evidence of habitual behaviour, TPB attitudes, risk perception, CS-SRM control by doctor, TPB perceived behavioural control and CS-SRM control by treatment entered the equation, together explaining 49% of the variance in intention.
Conclusion
The study provides evidence that psychological models can be useful in understanding and predicting clinical behaviour. Taking a theory-based approach enables the creation of a replicable methodology for identifying factors that predict clinical behaviour. However, a number of conceptual and methodological challenges remain.
doi:10.1186/1748-5908-2-26
PMCID: PMC2042498  PMID: 17683558
23.  Is annual surveillance of all treated hypothyroid patients necessary? 
Background
Annual surveillance (with thyroid function testing) is widely recommended for the long-term follow-up of treated hypothyroid patients. It is based largely on consensus opinion and there is limited evidence to support the frequency of monitoring. The majority of patients in our hospital based thyroid register are on 18 monthly follow-up.
Methods
We carried out a retrospective analysis to see if there is evidence to support more frequent testing. We used a logistic regression model to assess whether any baseline characteristics could be applied to predict an abnormal test.
Results
We identified 2,125 patients with a minimum of 10 years follow-up (89% female, 65% autoimmune hypothyroidism, and mean age at registration 51 years). There were 2 groups: 1182 (56%) had been allocated to 18 monthly follow-up and the rest had annual surveillance. The groups were well matched at baseline. Overall, during follow-up the 12 monthly group had more abnormal tests requiring dose adjustment. However, on logistic regression analysis, people aged less than 60 years, individuals taking < 150 μg thyroxine per day and people on 18 monthly follow-up had less abnormal tests.
Conclusion
18 monthly surveillance may be adequate in the long term follow-up of hypothyroid patients less than 60 years of age on a stable thyroxine dose of 100–150 μg/day where there are robust follow-up mechanisms in place. Implementing this strategy has potential for cost saving.
doi:10.1186/1472-6823-7-4
PMCID: PMC1920515  PMID: 17605766
24.  The Effects of Mandatory Prescribing of Thiazides for Newly Treated, Uncomplicated Hypertension: Interrupted Time-Series Analysis 
PLoS Medicine  2007;4(7):e232.
Background
The purpose of our study was to evaluate the effects of a new reimbursement rule for antihypertensive medication that made thiazides mandatory first-line drugs for newly treated, uncomplicated hypertension. The objective of the new regulation was to reduce drug expenditures.
Methods and Findings
We conducted an interrupted time-series analysis on prescribing data before and after the new reimbursement rule for antihypertensive medication was put into effect. All patients started on antihypertensive medication in 61 general practices in Norway were included in the analysis. The new rule was put forward by the Ministry of Health and was approved by parliament. Adherence to the rule was monitored only minimally, and there were no penalties for non-adherence. Our primary outcome was the proportion of thiazide prescriptions among all prescriptions made for persons started on antihypertensive medication. Secondary outcomes included the proportion of patients who, within 4 mo, reached recommended blood-pressure goals and the proportion of patients who, within 4 mo, were not started on a second antihypertensive drug. We also compared drug costs before and after the intervention. During the baseline period, 10% of patients started on antihypertensive medication were given a thiazide prescription. This proportion rose steadily during the transition period, after which it remained stable at 25%. For other outcomes, no statistically significant differences were demonstrated. Achievement of treatment goals was slightly higher (56.6% versus 58.4%) after the new rule was introduced, and the prescribing of a second drug was slightly lower (24.0% versus 21.8%). Drug costs were reduced by an estimated Norwegian kroner 4.8 million (€0.58 million, US$0.72 million) in the first year, which is equivalent to Norwegian kroner 1.06 per inhabitant (€0.13, US$0.16).
Conclusions
Prescribing of thiazides in Norway for uncomplicated hypertension more than doubled after a reimbursement rule requiring the use of thiazides as the first-choice therapy was put into effect. However, the resulting savings on drug expenditures were modest. There were no significant changes in the achievement of treatment goals or in the prescribing of a second antihypertensive drug.
Atle Fretheim and colleagues found that the prescribing of thiazides in Norway for uncomplicated hypertension more than doubled after a rule requiring their use as first-choice therapy was put into effect.
Editors' Summary
Background.
High blood pressure (hypertension) is a common medical condition, especially among elderly people. It has no obvious symptoms but can lead to heart attacks, heart failure, strokes, or kidney failure. It is diagnosed by measuring blood pressure—the force that blood moving around the body exerts on the inside of arteries (large blood vessels). Many factors affect blood pressure (which depends on the amount of blood being pumped round the body and on the size and condition of the arteries), but overweight people and individuals who eat fatty or salty food are at high risk of developing hypertension. Mild hypertension can often be corrected by making lifestyle changes, but many patients also take one or more antihypertensive agents. These include thiazide diuretics and several types of non-thiazide drugs, many of which reduce heart rate or contractility and/or dilate blood vessels.
Why Was This Study Done?
Antihypertensive agents are a major part of national drug expenditure in developed countries, where as many as one person in ten is treated for hypertension. The different classes of drugs are all effective, but their cost varies widely. Thiazides, for example, are a tenth of the price of many non-thiazide drugs. In Norway, the low use of thiazides recently led the government to impose a new reimbursement rule aimed at reducing public expenditure on antihypertensive drugs. Since March 2004, family doctors have been reimbursed for drug costs only if they prescribe thiazides as first-line therapy for uncomplicated hypertension, unless there are medical reasons for selecting other drugs. Adherence to the rule has not been monitored, and there is no penalty for non-adherence, so has this intervention changed prescribing practices? To find out, the researchers in this study analyzed Norwegian prescribing data before and after the new rule came into effect.
What Did the Researchers Do and Find?
The researchers analyzed the monthly antihypertensive drug–prescribing records of 61 practices around Oslo, Norway, between January 2003 and November 2003 (pre-intervention period), between December 2003 and February 2004 (transition period), and between March 2004 and January 2005 (post-intervention period). This type of study is called an “interrupted time series”. During the pre-intervention period, one in ten patients starting antihypertensive medication was prescribed a thiazide drug. This proportion gradually increased during the transition period before stabilizing at one in four patients throughout the post-intervention period. A slightly higher proportion of patients reached their recommended blood-pressure goal after the rule was introduced than before, and a slightly lower proportion needed to switch to a second drug class, but both these small differences may have been due to chance. Finally, the researchers estimated that the observed change in prescribing practices reduced drug costs per Norwegian by US$0.16 (€0.13) in the first year.
What Do These Findings Mean?
Past attempts to change antihypertensive-prescribing practices by trying to influence family doctors (for example, through education) have largely failed. By contrast, these findings suggest that imposing a change on them (in this case, by introducing a new reimbursement rule) can be effective (at least over the short term and in the practices included in the study), even when compliance with the change is not monitored nor noncompliance penalized. However, despite a large shift towards prescribing thiazides, three-quarters of patients were still prescribed non-thiazide drugs (possibly because of doubts about the efficacy of thiazides as first-line drugs), which emphasizes how hard it is to change doctors' prescribing habits. Further studies are needed to investigate whether the approach examined in this study can effectively contain the costs of antihypertensive drugs (and of drugs used for other common medical conditions) in the long term and in other settings. Also, because the estimated reduction in drug costs produced by the intervention was relatively modest (although likely to increase over time as more patients start on thiazides), other ways to change prescribing practices and produce savings in national drug expenditures should be investigated.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0040232.
MedlinePlus encyclopedia page on hypertension (in English and Spanish)
UK National Institute for Health and Clinical Excellence information on hypertension for patients, carers, and professionals
American Heart Association information for patients on high blood pressure
An open-access research article describing the potential savings of using thiazides as the first-choice antihypertensive drug
A previous study in Norway, published in PLoS Medicine, examined what happened when doctors were actively encouraged to make more use of thiazides. There was also an economic evaluation of what this achieved
doi:10.1371/journal.pmed.0040232
PMCID: PMC1904466  PMID: 17622192
25.  Toward Evidence-Based Quality Improvement: Evidence (and its Limitations) of the Effectiveness of Guideline Dissemination and Implementation Strategies 1966–1998 
Journal of General Internal Medicine  2006;21(Suppl 2):S14-S20.
OBJECTIVES
To determine effectiveness and costs of different guideline dissemination and implementation strategies.
DATA SOURCES
MEDLINE (1966 to 1998), HEALTHSTAR (1975 to 1998), Cochrane Controlled Trial Register (4th edn 1998), EMBASE (1980 to 1998), SIGLE (1980 to 1988), and the specialized register of the Cochrane Effective Practice and Organisation of Care group.
REVIEW METHODS: INCLUSION CRITERIA
Randomized-controlled trials, controlled clinical trials, controlled before and after studies, and interrupted time series evaluating guideline dissemination and implementation strategies targeting medically qualified health care professionals that reported objective measures of provider behavior and/or patient outcome. Two reviewers independently abstracted data on the methodologic quality of the studies, characteristics of study setting, participants, targeted behaviors, and interventions. We derived single estimates of dichotomous process variables (e.g., proportion of patients receiving appropriate treatment) for each study comparison and reported the median and range of effect sizes observed by study group and other quality criteria.
RESULTS
We included 309 comparisons derived from 235 studies. The overall quality of the studies was poor. Seventy-three percent of comparisons evaluated multifaceted interventions. Overall, the majority of comparisons (86.6%) observed improvements in care; for example, the median absolute improvement in performance across interventions ranged from 14.1% in 14 cluster-randomized comparisons of reminders, 8.1% in 4 cluster-randomized comparisons of dissemination of educational materials, 7.0% in 5 cluster-randomized comparisons of audit and feedback, and 6.0% in 13 cluster-randomized comparisons of multifaceted interventions involving educational outreach. We found no relationship between the number of components and the effects of multifaceted interventions. Only 29.4% of comparisons reported any economic data.
CONCLUSIONS
Current guideline dissemination and implementation strategies can lead to improvements in care within the context of rigorous evaluative studies. However, there is an imperfect evidence base to support decisions about which guideline dissemination and implementation strategies are likely to be efficient under different circumstances. Decision makers need to use considerable judgment about how best to use the limited resources they have for quality improvement activities.
doi:10.1111/j.1525-1497.2006.00357.x
PMCID: PMC2557130  PMID: 16637955
practice guideline; systematic review; implementation research.

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