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1.  Option Grids to facilitate shared decision making for patients with Osteoarthritis of the knee: protocol for a single site, efficacy trial 
Background
Despite policy interest, an ethical imperative, and evidence of the benefits of patient decision support tools, the adoption of shared decision making (SDM) in day-to-day clinical practice remains slow and is inhibited by barriers that include culture and attitudes; resources and time pressures. Patient decision support tools often require high levels of health and computer literacy. Option Grids are one-page evidence-based summaries of the available condition-specific treatment options, listing patients’ frequently asked questions. They are designed to be sufficiently brief and accessible enough to support a better dialogue between patients and clinicians during routine consultations. This paper describes a study to assess whether an Option Grid for osteoarthritis of the knee (OA of the knee) facilitates SDM, and explores the use of Option Grids by patients disadvantaged by language or poor health literacy.
Methods/Design
This will be a stepped wedge exploratory trial involving 72 patients with OA of the knee referred from primary medical care to a specialist musculoskeletal service in Oldham. Six physiotherapists will sequentially join the trial and consult with six patients using usual care procedures. After a period of brief training in using the Option Grid, the same six physiotherapists will consult with six further patients using an Option Grid in the consultation. The primary outcome will be efficacy of the Option Grid in facilitating SDM as measured by observational scores using the OPTION scale. Comparisons will be made between patients who have received the Option Grid and those who received usual care. A Decision Quality Measure (DQM) will assess quality of decision making. The health literacy of patients will be measured using the REALM-R instrument. Consultations will be observed and audio-recorded. Interviews will be conducted with the physiotherapists, patients and any interpreters present to explore their views of using the Option Grid.
Discussion
Option Grids offer a potential solution to the barriers to implementing traditional decision aids into routine clinical practice. The study will assess whether Option Grids can facilitate SDM in day-to-day clinical practice and explore their use with patients disadvantaged by language or poor health literacy.
Trial registration
Current Controlled Trials ISRCTN94871417
doi:10.1186/1472-6963-14-160
PMCID: PMC3986464  PMID: 24708747
Shared decision making; Decision aids; Osteoarthritis of the knee; Arthritis; Health literacy; Patient communication
2.  Prevalence of urinary tract infection in acutely unwell children in general practice: a prospective study with systematic urine sampling 
The British Journal of General Practice  2013;63(607):e156-e164.
Background
Urinary tract infection (UTI) in children may be associated with long-term complications that could be prevented by prompt treatment.
Aim
To determine the prevalence of UTI in acutely ill children ≤ 5 years presenting in general practice and to explore patterns of presenting symptoms and urine sampling strategies.
Design and setting
Prospective observational study with systematic urine sampling, in general practices in Wales, UK.
Method
In total, 1003 children were recruited from 13 general practices between March 2008 and July 2010. The prevalence of UTI was determined and multivariable analysis performed to determine the probability of UTI.
Result
Out of 597 (60.0%) children who provided urine samples within 2 days, the prevalence of UTI was 5.9% (95% confidence interval [CI] = 4.3% to 8.0%) overall, 7.3% in those < 3 years and 3.2% in 3–5 year olds. Neither a history of fever nor the absence of an alternative source of infection was associated with UTI (P = 0.64; P = 0.69, respectively). The probability of UTI in children aged ≥3 years without increased urinary frequency or dysuria was 2%. The probability of UTI was ≥5% in all other groups. Urine sampling based purely on GP suspicion would have missed 80% of UTIs, while a sampling strategy based on current guidelines would have missed 50%.
Conclusion
Approximately 6% of acutely unwell children presenting to UK general practice met the criteria for a laboratory diagnosis of UTI. This higher than previously recognised prior probability of UTI warrants raised awareness of the condition and suggests clinicians should lower their threshold for urine sampling in young children. The absence of fever or presence of an alternative source of infection, as emphasised in current guidelines, may not rule out UTI in young children with adequate certainty.
doi:10.3399/bjgp13X663127
PMCID: PMC3553642  PMID: 23561695
children; general practice; prevalence; symptoms; urinary tract infections
3.  “Many miles to go …”: a systematic review of the implementation of patient decision support interventions into routine clinical practice 
Background
Two decades of research has established the positive effect of using patient-targeted decision support interventions: patients gain knowledge, greater understanding of probabilities and increased confidence in decisions. Yet, despite their efficacy, the effectiveness of these decision support interventions in routine practice has yet to be established; widespread adoption has not occurred. The aim of this review was to search for and analyze the findings of published peer-reviewed studies that investigated the success levels of strategies or methods where attempts were made to implement patient-targeted decision support interventions into routine clinical settings.
Methods
An electronic search strategy was devised and adapted for the following databases: ASSIA, CINAHL, Embase, HMIC, Medline, Medline-in-process, OpenSIGLE, PsycINFO, Scopus, Social Services Abstracts, and the Web of Science. In addition, we used snowballing techniques. Studies were included after dual independent assessment.
Results
After assessment, 5322 abstracts yielded 51 articles for consideration. After examining full-texts, 17 studies were included and subjected to data extraction. The approach used in all studies was one where clinicians and their staff used a referral model, asking eligible patients to use decision support. The results point to significant challenges to the implementation of patient decision support using this model, including indifference on the part of health care professionals. This indifference stemmed from a reported lack of confidence in the content of decision support interventions and concern about disruption to established workflows, ultimately contributing to organizational inertia regarding their adoption.
Conclusions
It seems too early to make firm recommendations about how best to implement patient decision support into routine practice because approaches that use a ‘referral model’ consistently report difficulties. We sense that the underlying issues that militate against the use of patient decision support and, more generally, limit the adoption of shared decision making, are under-investigated and under-specified. Future reports from implementation studies could be improved by following guidelines, for example the SQUIRE proposals, and by adopting methods that would be able to go beyond the ‘barriers’ and ‘facilitators’ approach to understand more about the nature of professional and organizational resistance to these tools. The lack of incentives that reward the use of these interventions needs to be considered as a significant impediment.
doi:10.1186/1472-6947-13-S2-S14
PMCID: PMC4044318  PMID: 24625083
4.  Presenting quantitative information about decision outcomes: a risk communication primer for patient decision aid developers 
Background
Making evidence-based decisions often requires comparison of two or more options. Research-based evidence may exist which quantifies how likely the outcomes are for each option. Understanding these numeric estimates improves patients’ risk perception and leads to better informed decision making. This paper summarises current “best practices” in communication of evidence-based numeric outcomes for developers of patient decision aids (PtDAs) and other health communication tools.
Method
An expert consensus group of fourteen researchers from North America, Europe, and Australasia identified eleven main issues in risk communication. Two experts for each issue wrote a “state of the art” summary of best evidence, drawing on the PtDA, health, psychological, and broader scientific literature. In addition, commonly used terms were defined and a set of guiding principles and key messages derived from the results.
Results
The eleven key components of risk communication were: 1) Presenting the chance an event will occur; 2) Presenting changes in numeric outcomes; 3) Outcome estimates for test and screening decisions; 4) Numeric estimates in context and with evaluative labels; 5) Conveying uncertainty; 6) Visual formats; 7) Tailoring estimates; 8) Formats for understanding outcomes over time; 9) Narrative methods for conveying the chance of an event; 10) Important skills for understanding numerical estimates; and 11) Interactive web-based formats. Guiding principles from the evidence summaries advise that risk communication formats should reflect the task required of the user, should always define a relevant reference class (i.e., denominator) over time, should aim to use a consistent format throughout documents, should avoid “1 in x” formats and variable denominators, consider the magnitude of numbers used and the possibility of format bias, and should take into account the numeracy and graph literacy of the audience.
Conclusion
A substantial and rapidly expanding evidence base exists for risk communication. Developers of tools to facilitate evidence-based decision making should apply these principles to improve the quality of risk communication in practice.
doi:10.1186/1472-6947-13-S2-S7
PMCID: PMC4045391  PMID: 24625237
5.  Risk of cardiovascular disease? A qualitative study of risk interpretation among patients with high cholesterol 
BMC Family Practice  2013;14:137.
Background
Previous studies have shown the importance of paying attention to lay peoples’ interpretations of risk of disease, in order to explain health-related behavior. However, risk interpretations interplay with social context in complex ways. The objective was to explore how asymptomatic patients with high cholesterol interpret risk of cardiovascular disease.
Methods
Fourteen patients with high cholesterol and risk of cardiovascular disease were interviewed, and patterns across patient accounts were identified and analysed from an ethnographic approach.
Results
Information from the general practitioner about high cholesterol and risk of cardiovascular disease was reinterpreted in everyday social life. The risk associated with fatty foods was weighed against the pleasures of social and cultural events in which this type of food was common and cherished.
A positive mindset was applied as a strategy to lower the risk of having high cholesterol, but knowledge about risk was viewed as a cause of anxiety and self-absorption, and this anxiety made the body susceptible to disease, hampering the chances for healthy life.
Conclusion
Interpretations of high cholesterol and risk of cardiovascular disease are embedded in social relations and everyday life concerns. This should be addressed in general practice in preference-sensitive cases about risk-reducing medication.
Trial registration
ClinicalTrials.gov: NCT01187056
doi:10.1186/1471-2296-14-137
PMCID: PMC3850715  PMID: 24040920
Risk perception; Cardiovascular disease; High cholesterol; Qualitative research
6.  Patchy ‘coherence’: using normalization process theory to evaluate a multi-faceted shared decision making implementation program (MAGIC) 
Background
Implementing shared decision making into routine practice is proving difficult, despite considerable interest from policy-makers, and is far more complex than merely making decision support interventions available to patients. Few have reported successful implementation beyond research studies. MAking Good Decisions In Collaboration (MAGIC) is a multi-faceted implementation program, commissioned by The Health Foundation (UK), to examine how best to put shared decision making into routine practice. In this paper, we investigate healthcare professionals’ perspectives on implementing shared decision making during the MAGIC program, to examine the work required to implement shared decision making and to inform future efforts.
Methods
The MAGIC program approached implementation of shared decision making by initiating a range of interventions including: providing workshops; facilitating development of brief decision support tools (Option Grids); initiating a patient activation campaign (‘Ask 3 Questions’); gathering feedback using Decision Quality Measures; providing clinical leads meetings, learning events, and feedback sessions; and obtaining executive board level support. At 9 and 15 months (May and November 2011), two rounds of semi-structured interviews were conducted with healthcare professionals in three secondary care teams to explore views on the impact of these interventions. Interview data were coded by two reviewers using a framework derived from the Normalization Process Theory.
Results
A total of 54 interviews were completed with 31 healthcare professionals. Partial implementation of shared decision making could be explained using the four components of the Normalization Process Theory: ‘coherence,’ ‘cognitive participation,’ ‘collective action,’ and ‘reflexive monitoring.’ Shared decision making was integrated into routine practice when clinical teams shared coherent views of role and purpose (‘coherence’). Shared decision making was facilitated when teams engaged in developing and delivering interventions (‘cognitive participation’), and when those interventions fit with existing skill sets and organizational priorities (‘collective action’) resulting in demonstrable improvements to practice (‘reflexive monitoring’). The implementation process uncovered diverse and conflicting attitudes toward shared decision making; ‘coherence’ was often missing.
Conclusions
The study showed that implementation of shared decision making is more complex than the delivery of patient decision support interventions to patients, a portrayal that often goes unquestioned. Normalizing shared decision making requires intensive work to ensure teams have a shared understanding of the purpose of involving patients in decisions, and undergo the attitudinal shifts that many health professionals feel are required when comprehension goes beyond initial interpretations. Divergent views on the value of engaging patients in decisions remain a significant barrier to implementation.
doi:10.1186/1748-5908-8-102
PMCID: PMC3848565  PMID: 24006959
Shared decision making; Implementation; Patient-centered care; Normalization Process Theory
7.  Factors influencing the surgery intentions and choices of women with early breast cancer: the predictive utility of an extended theory of planned behaviour 
Background
Women diagnosed with early breast cancer (stage I or II) can be offered the choice between mastectomy or breast conservation surgery with radiotherapy due to equivalence in survival rates. A wide variation in the surgical management of breast cancer and a lack of theoretically guided research on this issue highlight the need for further research into the factors influencing women’s choices. An extended Theory of Planned Behaviour (TPB) could provide a basis to understand and predict women’s surgery choices. The aims of this study were to understand and predict the surgery intentions and choices of women newly diagnosed with early breast cancer, examining the predictive utility of an extended TPB.
Methods
Sixty-two women recruited from three UK breast clinics participated in the study; 48 women, newly diagnosed with early breast cancer, completed online questionnaires both before their surgery and after accessing an online decision support intervention (BresDex). Questionnaires assessed views about breast cancer and the available treatment options using items designed to measure constructs of an extended TPB (i.e., attitudes, subjective norms, perceived behavioural control, and anticipated regret), and women’s intentions to choose mastectomy or BCS. Objective data were collected on women’s choice of surgery via the clinical breast teams. Multiple and logistic regression analyses examined predictors of surgery intentions and subsequent choice of surgery.
Results
The extended TPB accounted for 69.9% of the variance in intentions (p <.001); attitudes and subjective norms were significant predictors. Including additional variables revealed anticipated regret to be a more important predictor than subjective norms. Surgery intentions significantly predicted surgery choices (p <.01).
Conclusions
These findings demonstrate the utility of an extended TPB in predicting and understanding women’s surgery intentions and choices for early breast cancer. Understanding these factors should help to identify key components of interventions to support women while considering their surgery options.
doi:10.1186/1472-6947-13-92
PMCID: PMC3849725  PMID: 23962230
Breast cancer; Mastectomy; Breast conserving surgery; Decision making; Theory of planned behaviour
8.  Communicating risk to patients and the public 
doi:10.3399/bjgp12X636236
PMCID: PMC3310025  PMID: 22520906
9.  What professional activities do general practitioners find most meaningful? Cross sectional survey of Norwegian general practitioners 
BMC Family Practice  2013;14:41.
Background
Health reforms in many countries affect the scope and nature of primary care. General Practitioners (GPs) are expected to spend more time developing public health, preventive health care, coordination of care and teamwork. We aimed to explore which professional activities GPs consider to be meaningful and how they would like to prioritise tasks.
Methods
In a cross sectional online survey 3,270 GPs were invited to consider twenty different activities in general practice. They were asked to rate each of them on a Likert scale anchored from 1 (not meaningful) to 5 (very meaningful). They then selected three activities from the item list on which they would like to spend more time and three activities on which they would like to spend less time. We used multinomial logistic regression to explore associations between the GPs’ preferences for time spent on preventive health care activities and age, gender and practice characteristics.
Results
Approximately 40% (n=1,308) responded. The most meaningful activities were handling common symptoms and complaints (94% scored 4 or 5), chronic somatic diseases (93%), terminal care (80%), chronic psychiatric diseases (77%), risk conditions (76%) and on call emergency services (70%). In terms of priority the same items prevailed except that GPs would like to spend less time on emergency services. Items with low priority were health certificates, practice administration, meetings with local health authorities, medically unexplained symptoms, addiction medicine, follow up of people certified unfit for work, psychosocial problems, preventive health clinics for children and school health services. In multivariate regression models physician and practice characteristics explained no more than 10% of the variability in the GPs’ preferences for time spent on preventive health care services.
Conclusions
The GPs found diagnosis and treatment of diseases most meaningful. Their priorities were partly at odds with those of the health authorities and policy makers.
doi:10.1186/1471-2296-14-41
PMCID: PMC3615944  PMID: 23522393
Health priorities; Health care reforms; General practice
10.  A cluster-randomised, parallel group, controlled intervention study of genetic prostate cancer risk assessment and use of PSA tests in general practice—the ProCaRis study: study protocol 
BMJ Open  2013;3(3):e002452.
Introduction
Unsystematic screening for prostate cancer (PCa) is common, causing a high number of false-positive results. Valid instruments for assessment of individual risk of PCa have been called for. A DNA-based genetic test has been tested retrospectively. The clinical use of this test needs further investigation. The primary objective is to evaluate the impact on the use of prostate-specific antigen (PSA) tests of introducing genetic PCa risk assessment in general practice. The secondary objectives are to evaluate PCa-related patient experiences, and to explore sociocultural aspects of genetic risk assessment in patients at high PCa risk.
Methods and analysis
The study is a cluster-randomised, controlled intervention study with practice as the unit of randomisation. We expect 140 practices to accept participation and include a total of 1244 patients in 4 months. Patients requesting a PSA test in the intervention group practices will be offered a genetic PCa risk assessment. Patients requesting a PSA test in the control group practices will be handled according to current guidelines. Data will be collected from registers, patient questionnaires and interviews. Quantitative data will be analysed according to intention-to-treat principles. Baseline characteristics will be compared between groups. Longitudinal analyses will include time in risk, and multivariable analysis will be conducted to evaluate the influence of general practitioner and patient-specific variables on future PSA testing. Interview data will be transcribed verbatim and analysed from a social-constructivist perspective.
Ethics and dissemination
Consent will be obtained from patients who can withdraw from the study at any time. The study provides data to the ongoing conceptual and ethical discussions about genetic risk assessment and classification of low-risk and high-risk individuals. The intervention model might be applicable to other screening areas regarding risk of cancer with identified genetic components, for example, colon cancer. The study is registered at the ClinicalTrials.gov (Identifier: NCT01739062).
doi:10.1136/bmjopen-2012-002452
PMCID: PMC3612777  PMID: 23457331
Prostate disease < UROLOGY
11.  Impact of effectiveness information format on patient choice of therapy and satisfaction with decisions about chronic disease medication: the "Influence of intervention Methodologies on Patient Choice of Therapy (IMPACT)" cluster-randomised trial in general practice 
Background
Risk communication is an integral part of shared decision-making in health care. In the context of interventions for chronic diseases it represents a particular challenge for all health practitioners. By using two different quantitative formats to communicate risk level and effectiveness of a cholesterol-lowering drug, we posed the research question: how does the format of risk information influence patients’ decisions concerning therapy, patients’ satisfaction with the communication as well as confidence in the decision. We hypothesise that patients are less prone to accept therapy when the benefits of long-term intervention are presented in terms of prolongation of life (POL) in months compared to the absolute risk reduction (ARR). We hypothesise that patients presented with POL will be more satisfied with the communication and confident in their decision, suggesting understanding of the time-related term.
Methods/Design
In 2009 a sample of 328 general practitioners (GPs) in the Region of Southern Denmark was invited to participate in a primary care-based clinical trial among patients making real-life clinical decisions together with their GP. Interested GPs were cluster-randomised to inform patients about cardiovascular disease (CVD) risk and the effectiveness of statin therapy using either POL or ARR. The GPs attended a training session before informing their patients. Before training and after the trial period they received a questionnaire about their attitudes to risk communication and the use of numerical information. Patients’ redemptions of statin prescriptions will be registered in a regional prescription database to evaluate a possible association between redemption rates and effectiveness format. The Combined Outcome Measure for Risk Communication And Treatment Decision Making Effectiveness (COMRADE) questionnaire will be used to measure patients’ confidence and satisfaction with the risk communication immediately after the conversation with their GPs.
Discussion
This randomised clinical trial compares the impact of two effectiveness formats on real-life risk communication between patients and GPs, including affective patient outcomes and actual choices about acceptance of therapy. Though we found difficulties in recruiting GPs, according to the study protocol we have succeeded in engaging sufficient GPs for the trial, enabling us to perform the planned analyses.
Trial registration
ClinicalTrials.gov Protocol Registration System http://ww.clinicaltrials.gov/NCT01414751
doi:10.1186/1472-6963-13-76
PMCID: PMC3599428  PMID: 23442351
RCT; Shared decision making; Risk communication; Prognosis; Absolute risk reduction; Prolongation of life; Cardiovascular disease; Primary prevention; Health behaviour; General practice
12.  Medication effectiveness may not be the major reason for accepting cardiovascular preventive medication: A population-based survey 
Background
Shared decision-making and patients’ choice of interventions are areas of increasing importance, not least seen in the light of the fact that chronic conditions are increasing, interventions considered important for public health, and still non-acceptance of especially risk-reducing treatments of cardiovascular diseases (CVD) is prevalent. A better understanding of patients’ medication-taking behavior is needed and may be reached by studying the reasons why people accept or decline medication recommendations. The aim of this paper was to identify factors that may influence people’s decisions and reasoning for accepting or declining a cardiovascular preventive medication offer.
Methods
From a random sample of 4,000 people aged 40–59 years in a Danish population, 1,169 participants were asked to imagine being at increased risk of cardiovascular disease and being offered a preventive medication. After receiving ‘complete’ information about effectiveness of the medication they were asked whether they would accept medication. Finally, they were asked about reasons for the decision.
Results
A total of 725 (67%) of 1,082 participants accepted the medication offer. Even quite large effects of medication (up to 8 percentage points absolute risk reduction) had a smaller impact on acceptance to medication than personal experience with cardiovascular disease. Furthermore, increasing age of the participant and living with a partner were significantly associated with acceptance. Some 45% of the respondents accepting justified their choice as being for health reasons, and they were more likely to be women, live alone, have higher income and higher education levels. Among those who did not accept the medication offer, 56% indicated that they would rather prefer to change lifestyle.
Conclusions
Medication effectiveness seems to have a moderate influence on people’s decisions to accept preventive medication, while factors such as personal experience with cardiovascular disease may have an equally strong or stronger influence, indicating that practitioners could do well to carefully identify the reasons for their patients’ treatment decisions.
doi:10.1186/1472-6947-12-89
PMCID: PMC3465182  PMID: 22873796
Decision-making; Risk assessment; Risk communication; Preventive health services; Primary prevention; Cardiovascular disease; Health behavior
13.  Shared Decision Making: A Model for Clinical Practice 
Journal of General Internal Medicine  2012;27(10):1361-1367.
The principles of shared decision making are well documented but there is a lack of guidance about how to accomplish the approach in routine clinical practice. Our aim here is to translate existing conceptual descriptions into a three-step model that is practical, easy to remember, and can act as a guide to skill development. Achieving shared decision making depends on building a good relationship in the clinical encounter so that information is shared and patients are supported to deliberate and express their preferences and views during the decision making process. To accomplish these tasks, we propose a model of how to do shared decision making that is based on choice, option and decision talk. The model has three steps: a) introducing choice, b) describing options, often by integrating the use of patient decision support, and c) helping patients explore preferences and make decisions. This model rests on supporting a process of deliberation, and on understanding that decisions should be influenced by exploring and respecting “what matters most” to patients as individuals, and that this exploration in turn depends on them developing informed preferences.
doi:10.1007/s11606-012-2077-6
PMCID: PMC3445676  PMID: 22618581
shared decision making; patient centered care
14.  Experiencing patient-experience surveys: a qualitative study of the accounts of GPs 
The British Journal of General Practice  2011;61(585):e157-e166.
Background
Despite policy and financial support for patient-experience surveys as feedback to modify clinical practice, their benefits and other effects remain unclear.
Aim
This study aimed to examine the perspective of GPs who have engaged with such tools.
Method
Qualitative semi-structured interviews with 30 GPs across south Wales, UK. The transcripts were analysed using a constant comparative method.
Results
The participants regarded patient feedback as highly important but felt that patient-experience surveys, as currently implemented, were hard to interpret. Reflecting on the doctor–patient interaction, participants perceived ambiguity about whether results were evaluating the individual or the GP practice, and whether they were directed towards the ‘practitioner-as-person’ or towards specific behaviours. A potential threat was posed in both interpretations, with the risk of damaging consequences for the practitioner and the nature of general practice. The tension between satisfying patients and performing good health care was a clearly voiced dilemma. Doctors did not feel confident in their ability to change in response to feedback, particularly outside a formal training environment.
Conclusion
Patient evaluation is seen as a key part of multisource feedback for practising doctors. Clarity is needed about the purpose of evaluation – whether for organisational or personal ‘feedback’, and whether formative or summative – and there is a need for attention to the process, with trained facilitators, to ensure that doctors gain from structured reflection, and can minimise the potential negative effects of evaluation.
doi:10.3399/bjgp11X567072
PMCID: PMC3063044  PMID: 21439173
general practice; patient experience; qualitative
15.  The development of health literacy in patients with a long-term health condition: the health literacy pathway model 
BMC Public Health  2012;12:130.
Background
Inadequate health literacy has been associated with poor management of long-term health conditions and has been identified as a key social determinant of health outcomes. However, little is understood about how health literacy might develop over time or the processes by which people may become more health literate. Our objectives were to describe how patients with a long-term condition practice health literacy in the management of their health and communication with health professionals, how they become more health literate over time and their experience of using health services. We also sought to identify and describe the motivations, facilitators and barriers in the practice of health literacy in healthcare consultations.
Methods
We designed a longitudinal qualitative study using serial interviews with 18 participants to explore their experiences of learning to manage their condition and their experiences of health literacy when participating in healthcare processes. Participants were recruited from patient education programmes and were interviewed three times over a period of 9 months. A framework approach was used to analyse data.
Results
A model is presented that illustrates the development of health literacy along a trajectory that includes the development of knowledge, health literacy skills and practices, health literacy actions, abilities in seeking options and informed and shared decision making opportunities. Motivations and barriers to developing and practising health literacy skills partly reflected participants' characteristics but were also influenced by health professionals. Some participants developed their health literacy to a point where they became more involved in healthcare processes (including informed and shared decision-making).
Conclusions
Patients with a long-term condition can develop health literacy skills over time and put their skills into practice in becoming more active in healthcare consultations. Our findings have implications for developing health literacy interventions aimed at patient involvement in healthcare processes and improved self-management of long-term conditions.
doi:10.1186/1471-2458-12-130
PMCID: PMC3305618  PMID: 22332990
16.  Complaints against doctors 
BMJ : British Medical Journal  2008;336(7649):841-842.
Could be reduced by identifying and remedying poor communication skills early on
doi:10.1136/bmj.39525.658565.80
PMCID: PMC2323071  PMID: 18420664
17.  Streamline triage and manage user expectations: lessons from a qualitative study of GP out-of-hours services 
Background
Several models of GP out-of-hours provision exist in the UK but there is little detail about their effectiveness to meet users' needs and expectations.
Aim
To explore users' needs, expectations, and experiences of out-of-hours care, and to identify proposals for service redesign.
Setting
Service providers in urban (GP cooperative), mixed (hospital based), rural (private) locations in Wales.
Participants
Sixty recent service users or carers (20 in each location).
Method
Semi-structured telephone interviews; thematic analysis.
Results
Users' concerns were generally consistent across the three different services. Efficiency was a major concern, with repetitive triage procedures and long time delays at various stages in the process being problematic. Access to a doctor when required was also important to users, who perceived an obstructive gatekeeping function of preliminary contacts. Expectations moderated the relationship between user concerns and satisfaction. Where expectations of outcome were unfulfilled, participants reported greater likelihood of reconsulting with the same or alternative services for the same illness episode. Accurate expectations concerning contacts with the next administrative, nursing, or medical staff professional were managed by appropriate information provision.
Conclusion
Users require more streamlined and flexible triage systems. Their expectations need to be understood and incorporated into how services advise and provide services for users, and actively managed to meet the aims of both enhancing satisfaction and enabling users to cope with their condition. Better information and education about services are needed if users are to derive the greatest benefit and satisfaction. This may influence choices about using the most appropriate forms of care.
doi:10.3399/bjgp10X483490
PMCID: PMC2828862  PMID: 20202350
out-of-hours medical care; family medicine; qualitative evaluation
18.  Prevalence of urinary tract infection (UTI) in sequential acutely unwell children presenting in primary care: Exploratory study 
Background
Due to the non-specific nature of symptoms of UTI in children and low levels of urine sampling, the prevalence of UTI amongst acutely ill children in primary care is unknown.
Objectives
To undertake an exploratory study of acutely ill children consulting in primary care, determine the feasibility of obtaining urine samples, and describe presenting symptoms and signs, and the proportion with UTI.
Design
Exploratory, observational study.
Setting
Four general practices in South Wales.
Subjects
A total of 99 sequential attendees with acute illness aged less than five years.
Main outcome measure
UTI defined by >105 organisms/ml on laboratory culture of urine.
Results
Urine samples were obtained in 75 (76%) children. Three (4%) met microbiological criteria for UTI. GPs indicated they would not normally have obtained urine samples in any of these three children. However, all had received antibiotics for suspected alternative infections.
Conclusion
Urine sample collection is feasible from the majority of acutely ill children in primary care, including infants. Some cases of UTI may be missed if children thought to have an alternative site of infection are excluded from urine sampling. A larger study is needed to more accurately determine the prevalence of UTI in children consulting with acute illness in primary care, and to explore which symptoms and signs might help clinicians effectively target urine sampling.
doi:10.3109/02813432.2011.554268
PMCID: PMC3347928  PMID: 21323495
Children; diagnosis; prevalence; primary care; urinary tract infection
19.  Exploring patients’ self-reported experiences of out-of-hours primary care and their suggestions for improvement: a qualitative study 
Family Practice  2010;28(2):210-219.
Background and objective. Out-of-hours services for primary care provision are increasing in policy relevance. The aim of this qualitative study was to explore service users’ recent experiences of out-of-hours services and to identify suggestions for improvement for services and practitioners involved.
Methods. We used data from a cross-sectional survey of service users’ self-reported experiences of 13 out-of-hours centres in Wales. Three hundred and forty-one respondents provided free-text comments focusing on suggestions for improvement within the survey instrument (the Out-of-hours Patient Questionnaire). A coding framework was based on previous literature focusing on patients’ experiences of out-of-hours services, built upon and refined as it was systematically applied to the data. Emergent themes and subthemes were charted and interpreted to comprise the findings.
Results. Central themes emerged from users’ perspectives of the structure of out-of-hours services, process of care and outcomes for users. Themes included long waiting times, perceived quality of service user–practitioner communication, consideration for parents and children and accessibility of the service and medication. Suggestions for improving care were made across these themes, including triaging patients more effectively and efficiently, addressing specific aspects of practitioners’ communication with patients, reconsidering the size of areas covered by services and number of professionals required for the population covered, extending GP and pharmacy opening times and medication delivery services.
Conclusions. It is important to consider ways to address service users’ principal concerns surrounding out-of-hours services. Debate is required about prioritizing and implementing potential improvements to out-of-hours services in the light of resource constraints.
doi:10.1093/fampra/cmq090
PMCID: PMC3062781  PMID: 21059702
Framework analysis; improvements; out-of-hours care; patients’ experiences; qualitative
20.  The RISAP-study: a complex intervention in risk communication and shared decision-making in general practice 
BMC Family Practice  2010;11:70.
Background
General practitioners (GPs) and patients find it difficult to talk about risk of future disease, especially when patients have asymptomatic conditions, and treatment options are unlikely to cause immediate perceptible improvements in well-being. Further studies in risk communication training are needed. Aim:1) to systematically develop, describe and evaluate a complex intervention comprising a training programme for GPs in risk communication and shared decision-making, 2) to evaluate the effect of the training programme on real-life consultations between GPs and patients with high cholesterol levels, and 3) to evaluate patients' reactions during and after the consultations.
Methods/Design
The effect of the complex intervention, based around a training programme, will be evaluated in a cluster-randomised controlled trial with an intervention group and an active control group with 40 GPs and 280 patients in each group.
The GPs will receive a questionnaire at baseline and after 6 months about attitudes towards risk communication and cholesterol-reducing medication. After each consultation with a participating high cholesterol-patient, the GPs will complete a questionnaire about decision satisfaction (Provider Decision Process Assessment Instrument). The patients will receive a questionnaire at baseline and after 3 and 6 months. It includes questions about adherence to chosen treatment (Morisky Compliance Scale), self-rated health (SF-12), enablement (Patient Enablement Instrument), and risk communication and decision-making effectiveness (COMRADE Scale). Prescriptions, contacts to the health services, and cholesterol level will be drawn from the registers.
In each group, 12 consultations will be observed and tape-recorded. The patients from these 24 consultations will be interviewed immediately after the consultation and re-interviewed after 6 months.
Eight purposefully selected GPs from the intervention group will be interviewed in a focus group 6 months after participation in the training programme.
The process and context of the RISAP-study will be investigated in detail using an action research approach, in order to analyse adaptation of the intervention model to the specific context.
Discussion
This study aims at providing GPs and patients with a firm basis for active deliberation about preventive treatment options, with a view to optimising adherence to chosen treatment.
Trial registration
ClinicalTrials.gov Protocol Registration System NCT01187056
doi:10.1186/1471-2296-11-70
PMCID: PMC2954954  PMID: 20860820
21.  Preventing disease through opportunistic, rapid engagement by primary care teams using behaviour change counselling (PRE-EMPT): protocol for a general practice-based cluster randomised trial 
BMC Family Practice  2010;11:69.
Background
Smoking, excessive alcohol consumption, lack of exercise and an unhealthy diet are the key modifiable factors contributing to premature morbidity and mortality in the developed world. Brief interventions in health care consultations can be effective in changing single health behaviours. General Practice holds considerable potential for primary prevention through modifying patients' multiple risk behaviours, but feasible, acceptable and effective interventions are poorly developed, and uptake by practitioners is low. Through a process of theoretical development, modeling and exploratory trials, we have developed an intervention called Behaviour Change Counselling (BCC) derived from Motivational Interviewing (MI). This paper describes the protocol for an evaluation of a training intervention (the Talking Lifestyles Programme) which will enable practitioners to routinely use BCC during consultations for the above four risk behaviours.
Methods/Design
This cluster randomised controlled efficacy trial (RCT) will evaluate the outcomes and costs of this training intervention for General Practitioners (GPs) and nurses. Training methods will include: a practice-based seminar, online self-directed learning, and reflecting on video recorded and simulated consultations. The intervention will be evaluated in 29 practices in Wales, UK; two clinicians will take part (one GP and one nurse) from each practice. In intervention practices both clinicians will receive training. The aim is to recruit 2000 patients into the study with an expected 30% drop out. The primary outcome will be the proportion of patients making changes in one or more of the four behaviours at three months. Results will be compared for patients seeing clinicians trained in BCC with patients seeing non-BCC trained clinicians. Economic and process evaluations will also be conducted.
Discussion
Opportunistic engagement by health professionals potentially represents a cost effective medical intervention. This study integrates an existing, innovative intervention method with an innovative training model to enable clinicians to routinely use BCC, providing them with new tools to encourage and support people to make healthier choices. This trial will evaluate effectiveness in primary care and determine costs of the intervention.
Trial Registration
ISRCTN22495456
doi:10.1186/1471-2296-11-69
PMCID: PMC2955601  PMID: 20858273
22.  Supporting Informed Decision Making for Prostate Specific Antigen (PSA) Testing on the Web: An Online Randomized Controlled Trial 
Background
Men considering the prostate specific antigen (PSA) test for prostate cancer, an increasingly common male cancer, are encouraged to make informed decisions, as the test is limited in its accuracy and the natural history of the condition is poorly understood. The Web-based PSA decision aid, Prosdex, was developed as part of the UK Prostate Cancer Risk Management Programme in order to help men make such informed decisions.
Objectives
The aim of this study was to evaluate the effect of the Web-based PSA decision aid, Prosdex, on informed decision making.
Methods
A Web-based randomized controlled trial was conducted in South Wales, United Kingdom. Men aged 50 to 75 who had not previously had a PSA test were randomly allocated to two intervention and two control groups. Participants in the intervention groups either viewed Prosdex or were given a paper version of the text. The main outcome measures were the three components of informed decision making: (1) knowledge of prostate cancer and PSA, (2) attitude toward PSA testing, (3) behavior using a proxy measure, intention to undergo PSA testing. Decisional conflict and anxiety were also measured as was uptake of the PSA test. Outcomes were measured by means of an online questionnaire for the Prosdex group, the paper version group, and one of two control groups. Six months later, PSA test uptake was ascertained from general practitioners’ records, and the online questionnaire was repeated. Results are reported in terms of the Mann-Whitney U-statistic divided by the product of the two sample sizes (U/mm), line of no effect 0.50.
Results
Participants were 514 men. Compared with the control group that completed the initial online questionnaire, men in the Prosdex group had increased knowledge about the PSA test and prostate cancer (U/mn 0.70; 95% CI 0.62 - 0.76); less favourable attitudes to PSA testing (U/mn 0.39, 95% CI 0.31 - 0.47); were less likely to undergo PSA testing (U/mn 0.40, 95% CI 0.32 - 0.48); and had less decisional conflict (U/mn 0.32, 95% CI 0.25 - 0.40); while anxiety level did not differ (U/mn 0.50, 95% CI 0.42 - 0.58). For these outcomes there were no significant differences between men in the Prosdex group and the paper version group. However, in the Prosdex group, increased knowledge was associated with a less favourable attitude toward testing (Spearman rank correlation [ρ] = -0.49, P < .001) and lower intention to undergo testing (ρ = -0.27, P = .02). After six months, PSA test uptake was lower in the Prosdex group than in the paper version and the questionnaire control group (P = .014). Test uptake was also lower in the control group that did not complete a questionnaire than in the control group that did, suggesting a possible Hawthorne effect of the questionnaire in favour of PSA testing.
Conclusions
Exposure to Prosdex was associated with improved knowledge about the PSA test and prostate cancer. Men who had a high level of knowledge had a less favourable attitude toward and were less likely to undergo PSA testing. Prosdex appears to promote informed decision making regarding the PSA test.
Trial Registration
ISRCTN48473735; http://www.controlled-trials.com/ISRCTN48473735 (Archived by WebCite at http://www.webcitation.org/5r1TLQ5nK)
doi:10.2196/jmir.1305
PMCID: PMC2956331  PMID: 20693148
Decision aid; Informed decision making; Internet; Prostate cancer; Prostate Specific Antigen (PSA) test
23.  Supporting Informed Decision Making Online in 20 Minutes: An Observational Web-log Study of a PSA Test Decision Aid  
Background
Web-based decision aids are known to have an effect on knowledge, attitude, and behavior; important components of informed decision making. We know what decision aids achieve in randomized controlled trials (RCTs), but we still know very little about how they are used and how this relates to the informed decision making outcome measures.
Objective
To examine men's use of an online decision aid for prostate cancer screening using website transaction log files (web-logs), and to examine associations between usage and components of informed decision making.
Methods
We conducted an observational web-log analysis of users of an online decision aid, Prosdex. Men between 50 and 75 years of age were recruited for an associated RCT from 26 general practices across South Wales, United Kingdom. Men allocated to one arm of the RCT were included in the current study. Time and usage data were derived from website log files. Components of informed decision making were measured by an online questionnaire.
Results
Available for analysis were 82 web-logs. Overall, there was large variation in the use of Prosdex. The mean total time spent on the site was 20 minutes. The mean number of pages accessed was 32 (SD 21) out of a possible 60 pages. Significant associations were found between increased usage and increased knowledge (Spearman rank correlation [ρ] = 0.69, P < .01), between increased usage and less favorable attitude towards PSA testing (ρ = -0.52, P < .01), and between increased usage and reduced intention to undergo PSA testing (ρ = -0.44, P < .01). A bimodal distribution identified two types of user: low access and high access users.
Conclusions
Increased usage of Prosdex leads to more informed decision making, the key aim of the UK Prostate Cancer Risk Management Programme. However, developers realistically have roughly 20 minutes to provide useful information that will support informed decision making when the patient uses a web-based interface. Future decision aids need to be developed with this limitation in mind. We recommend that web-log analysis should be an integral part of online decision aid development and analysis.
Trial Registration
ISRCTN48473735; http://www.controlled-trials.com/ISRCTN48473735 (Archived by WebCite at http://www.webcitation.org/5pqeF89tS)
doi:10.2196/jmir.1307
PMCID: PMC2956226  PMID: 20507844
decision aid; informed decision making; internet; prostate cancer; prostate specific antigen (PSA) test; user tracking; web-log; website transaction log file
24.  Absolute risk representation in cardiovascular disease prevention: comprehension and preferences of health care consumers and general practitioners involved in a focus group study 
BMC Public Health  2010;10:108.
Background
Communicating risk is part of primary prevention of coronary heart disease and stroke, collectively referred to as cardiovascular disease (CVD). In Australia, health organisations have promoted an absolute risk approach, thereby raising the question of suitable standardised formats for risk communication.
Methods
Sixteen formats of risk representation were prepared including statements, icons, graphical formats, alone or in combination, and with variable use of colours. All presented the same risk, i.e., the absolute risk for a 55 year old woman, 16% risk of CVD in five years. Preferences for a five or ten-year timeframe were explored. Australian GPs and consumers were recruited for participation in focus groups, with the data analysed thematically and preferred formats tallied.
Results
Three focus groups with health consumers and three with GPs were held, involving 19 consumers and 18 GPs.
Consumers and GPs had similar views on which formats were more easily comprehended and which conveyed 16% risk as a high risk. A simple summation of preferences resulted in three graphical formats (thermometers, vertical bar chart) and one statement format as the top choices. The use of colour to distinguish risk (red, yellow, green) and comparative information (age, sex, smoking status) were important ingredients. Consumers found formats which combined information helpful, such as colour, effect of changing behaviour on risk, or comparison with a healthy older person. GPs preferred formats that helped them relate the information about risk of CVD to their patients, and could be used to motivate patients to change behaviour.
Several formats were reported as confusing, such as a percentage risk with no contextual information, line graphs, and icons, particularly those with larger numbers.
Whilst consumers and GPs shared preferences, the use of one format for all situations was not recommended. Overall, people across groups felt that risk expressed over five years was preferable to a ten-year risk, the latter being too remote.
Conclusions
Consumers and GPs shared preferences for risk representation formats. Both groups liked the option to combine formats and tailor the risk information to reflect a specific individual's risk, to maximise understanding and provide a good basis for discussion.
doi:10.1186/1471-2458-10-108
PMCID: PMC2845101  PMID: 20199692
25.  Assessing the Quality of Decision Support Technologies Using the International Patient Decision Aid Standards instrument (IPDASi) 
PLoS ONE  2009;4(3):e4705.
Objectives
To describe the development, validation and inter-rater reliability of an instrument to measure the quality of patient decision support technologies (decision aids).
Design
Scale development study, involving construct, item and scale development, validation and reliability testing.
Setting
There has been increasing use of decision support technologies – adjuncts to the discussions clinicians have with patients about difficult decisions. A global interest in developing these interventions exists among both for-profit and not-for-profit organisations. It is therefore essential to have internationally accepted standards to assess the quality of their development, process, content, potential bias and method of field testing and evaluation.
Methods
Scale development study, involving construct, item and scale development, validation and reliability testing.
Participants
Twenty-five researcher-members of the International Patient Decision Aid Standards Collaboration worked together to develop the instrument (IPDASi). In the fourth Stage (reliability study), eight raters assessed thirty randomly selected decision support technologies.
Results
IPDASi measures quality in 10 dimensions, using 47 items, and provides an overall quality score (scaled from 0 to 100) for each intervention. Overall IPDASi scores ranged from 33 to 82 across the decision support technologies sampled (n = 30), enabling discrimination. The inter-rater intraclass correlation for the overall quality score was 0.80. Correlations of dimension scores with the overall score were all positive (0.31 to 0.68). Cronbach's alpha values for the 8 raters ranged from 0.72 to 0.93. Cronbach's alphas based on the dimension means ranged from 0.50 to 0.81, indicating that the dimensions, although well correlated, measure different aspects of decision support technology quality. A short version (19 items) was also developed that had very similar mean scores to IPDASi and high correlation between short score and overall score 0.87 (CI 0.79 to 0.92).
Conclusions
This work demonstrates that IPDASi has the ability to assess the quality of decision support technologies. The existing IPDASi provides an assessment of the quality of a DST's components and will be used as a tool to provide formative advice to DSTs developers and summative assessments for those who want to compare their tools against an existing benchmark.
doi:10.1371/journal.pone.0004705
PMCID: PMC2649534  PMID: 19259269

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