Cancer Clinicians' Views Regarding an App That Helps Patients With Cancer Meet Their Information Needs: Qualitative Interview Study.

BACKGROUND: Many patients with cancer have unmet information needs during the course of the illness. Smart devices, such as smartphones and tablet computers, provide an opportunity to deliver information to patients remotely. We aim to develop an app intervention to help patients with cancer meet their illness-related information needs in noninpatient settings. In addition to the in-depth exploration of the issues faced by the target users of a potential intervention, it is important to gain an understanding of the context in which the intervention will be used and the potential influences on its adoption. As such, understanding the views of clinicians is key to the successful implementation of this type of app in practice. Additionally, clinicians have an awareness of their patients' needs and can provide further insight into the type of app and features that might be most beneficial. OBJECTIVE: This study aims to explore cancer clinicians' views on this type of intervention and whether they would support the use of an app in cancer care. Specifically, the perceived acceptability of an app used in consultations, useful app features, the potential benefits and disadvantages of an app, and barriers to app use were explored. METHODS: A total of 20 qualitative, semistructured interviews were conducted with 22 clinicians from urological, colorectal, breast, or gynecological cancer clinics across 2 hospitals in South Wales. The interviews were audio recorded, transcribed, and analyzed using thematic analysis. RESULTS: Clinicians felt that it would be acceptable for patients to use such an app in noninpatient settings, including during consultations. The benefits of this type of app were anticipated to be a more informed patient, an increased sense of control for patients, better doctor-patient communication, and a more efficient and effective consultation. In contrast, an increase in clinicians' workload and poorer communication in consultations, which depended on the included app features, were identified as potential disadvantages. The anticipated barriers to app use included patients' age and prior experience with smart technology, their access to smart devices, the confidentiality of information, and an avoidant coping approach to their condition. CONCLUSIONS: This study suggests that clinicians should support their patients in using an app to help them meet their information needs both at home and during consultations. This study highlights some of the potential barriers for this type of intervention in practice, which could be minimized during the intervention design process.

Underpinning of the sharing knowledge about immunisation (SKAI) communication approach: A qualitative study using recorded observations.

OBJECTIVE: To refine communication strategies to assist clinician conversations with vaccine hesitant and declining parents as part of the Sharing Knowledge About Immunisation (SKAI) package. METHODS: We recorded and analysed consultations held in two Specialist Immunisation Clinics in tertiary hospitals in Australia between consenting clinicians and parents. We undertook content analysis that was both iterative and informed by the Calgary Cambridge Model of health communication and motivational interviewing. RESULTS: We found common strengths and opportunities in clinician's communication styles. Strengths included: rapport building; communicating care for both the parent and child; exhibiting depth of vaccination-specific communication skill and content knowledge. Opportunities for strengthening communication practices included: eliciting parents' concerns to saturation early in the consultation; structuring the consultation to prioritise and address parents' concerns; recognising and responding to parents' motivation to vaccinate; effectively closing consultations. CONCLUSION: This study has synthesised clinical communication strategies from expert vaccination communicators using well-established communication frameworks to advance a unique approach to the challenging task of addressing vaccine hesitancy and refusal. PRACTICE IMPLICATIONS: The clinic observations helped us to create a structured consultation guide that can enhance and provide greater structure to a clinician's existing communication skills.

The Preferences of Patients With Cancer Regarding Apps to Help Meet Their Illness-Related Information Needs: Qualitative Interview Study.

BACKGROUND: The shift from inpatient to outpatient and community cancer care means that more patients with cancer need to manage their condition at home, without the direct supervision of their clinician. Subsequently, research has reported that many patients with cancer have unmet information needs during their illness. Mobile devices, such as mobile phones and tablet computers, provide an opportunity to deliver information to patients remotely. Before designing an app intervention to help patients with cancer to meet their information needs, in-depth qualitative research is required to gain an understanding of the views of the target users. OBJECTIVE: We aimed to develop an app intervention to help patients meet their illness-related information needs in noninpatient settings. This study explored the information needs of patients with cancer and their preferences for an app and desired app features. Specifically, the perceived acceptability of an app, desired app features, and the potential benefits and disadvantages of, and barriers to, an app were explored. METHODS: Qualitative, one-on-one semistructured interviews were conducted with patients with urological, colorectal, breast, or gynecological cancers (N=23) across two hospitals in South Wales. Interviews were audio-taped, transcribed, and analyzed using a thematic analysis. RESULTS: Findings indicated that barriers to information exchange and understanding in consultations, and identification of reliable information sources between consultations, appeared to contribute to patients' unmet information needs. Consequently, app feature suggestions included a question prompt list, a glossary of cancer terms, a resources feature, and a contacts feature. Anticipated benefits of this type of app included a more informed patient, improved quality of life, decreased anxiety, and increased confidence to participate in their care. The anticipated barriers to app use are likely to be temporary or can be minimized with regard to these findings during app development and implementation. CONCLUSIONS: This study highlights the desire of patients with cancer for an app intervention to help them meet their information needs during and between consultations with their clinicians. This study also highlights the anticipated acceptability and benefits of this type of intervention; however, further research is warranted.

Use of Mobile Devices to Help Cancer Patients Meet Their Information Needs in Non-Inpatient Settings: Systematic Review.

BACKGROUND: The shift from inpatient to outpatient cancer care means that patients are now required to manage their condition at home, away from regular supervision by clinicians. Subsequently, research has consistently reported that many patients with cancer have unmet information needs during their illness. Mobile devices, such as mobile phones and tablet computers, provide an opportunity to deliver information to patients remotely. To date, no systematic reviews have evaluated how mobile devices have been used specifically to help patients meet to their information needs. OBJECTIVE: A systematic review was conducted to identify studies that describe the use of mobile interventions to enable patients with cancer meet their cancer-related information needs in non-inpatient settings, and to describe the effects and feasibility of these interventions. METHODS: MEDLINE, Embase, and PsycINFO databases were searched up until January 2017. Search terms related to "mobile devices," "information needs," and "cancer" were used. There were no restrictions on study type in order to be as inclusive as possible. Study participants were patients with cancer undergoing treatment. Interventions had to be delivered by a mobile or handheld device, attempt to meet patients' cancer-related information needs, and be for use in non-inpatient settings. Critical Appraisal Skills Programme checklists were used to assess the methodological quality of included studies. A narrative synthesis was performed and findings were organized by common themes found across studies. RESULTS: The initial search yielded 1020 results. We included 23 articles describing 20 studies. Interventions aimed to improve the monitoring and management of treatment-related symptoms (17/20, 85%), directly increase patients' knowledge related to their condition (2/20, 10%), and improve communication of symptoms to clinicians in consultations (1/20, 5%). Studies focused on adult (17/20; age range 24-87 years) and adolescent (3/20; age range 8-18 years) patients. Sample sizes ranged from 4-125, with 13 studies having 25 participants or fewer. Most studies were conducted in the United Kingdom (12/20, 52%) or United States (7/20, 30%). Of the 23 articles included, 12 were of medium quality, 9 of poor quality, and 2 of good quality. Overall, interventions were reported to be acceptable and perceived as useful and easy to use. Few technical problems were encountered. Adherence was generally consistent and high (periods ranged from 5 days to 6 months). However, there was considerable variation in use of intervention components within and between studies. Reported benefits of the interventions included improved symptom management, patient empowerment, and improved clinician-patient communication, although mixed findings were reported for patients' health-related quality of life and anxiety. CONCLUSIONS: The current review highlighted that mobile interventions for patients with cancer are only meeting treatment or symptom-related information needs. There were no interventions designed to meet patients' full range of cancer-related information needs, from information on psychological support to how to manage finances during cancer, and the long-term effects of treatment. More comprehensive interventions are required for patients to meet their information needs when managing their condition in non-inpatient settings. Controlled evaluations are needed to further determine the effectiveness of these types of intervention.

Sharing knowledge about immunisation (SKAI): An exploration of parents' communication needs to inform development of a clinical communication support intervention.

INTRODUCTION: The SKAI (Sharing Knowledge About Immunisation) project aims to develop effective communication tools to support primary health care providers' consultations with parents who may be hesitant about vaccinating their children. AIM: This study explored parents' communication needs using a qualitative design. METHODS: Parents of at least one child less than five years old were recruited from two major cities and a regional town known for high prevalence of vaccine objection. Focus groups of parents who held similar vaccination attitudes and intentions were convened to discuss experiences of vaccination consultations and explore their communication needs, including preferences. Draft written communication support tools were used to stimulate discussion and gauge acceptability of the tools. RESULTS: Important differences in communication needs between group types emerged. The least hesitant parent groups reported feeling reassured upon reading resources designed to address commonly observed concerns about vaccination. As hesitancy of the group members increased, so did their accounts of the volume and detail of information they required. Trust appeared to be related to apparent or perceived transparency. More hesitant groups displayed increased sensitivity and resistance to persuasive language forms.

A three-talk model for shared decision making: multistage consultation process.

Objectives To revise an existing three-talk model for learning how to achieve shared decision making, and to consult with relevant stakeholders to update and obtain wider engagement.Design Multistage consultation process.Setting Key informant group, communities of interest, and survey of clinical specialties.Participants 19 key informants, 153 member responses from multiple communities of interest, and 316 responses to an online survey from medically qualified clinicians from six specialties.Results After extended consultation over three iterations, we revised the three-talk model by making changes to one talk category, adding the need to elicit patient goals, providing a clear set of tasks for each talk category, and adding suggested scripts to illustrate each step. A new three-talk model of shared decision making is proposed, based on "team talk," "option talk," and "decision talk," to depict a process of collaboration and deliberation. Team talk places emphasis on the need to provide support to patients when they are made aware of choices, and to elicit their goals as a means of guiding decision making processes. Option talk refers to the task of comparing alternatives, using risk communication principles. Decision talk refers to the task of arriving at decisions that reflect the informed preferences of patients, guided by the experience and expertise of health professionals.Conclusions The revised three-talk model of shared decision making depicts conversational steps, initiated by providing support when introducing options, followed by strategies to compare and discuss trade-offs, before deliberation based on informed preferences.

Core information sets for informed consent to surgical interventions: baseline information of importance to patients and clinicians.

BACKGROUND: Consent remains a crucial, yet challenging, cornerstone of clinical practice. The ethical, legal and professional understandings of this construct have evolved away from a doctor-centred act to a patient-centred process that encompasses the patient's values, beliefs and goals. This alignment of consent with the philosophy of shared decision-making was affirmed in a recent high-profile Supreme Court ruling in England. The communication of information is central to this model of health care delivery but it can be difficult for doctors to gauge the information needs of the individual patient. The aim of this paper is to describe 'core information sets' which are defined as a minimum set of consensus-derived information about a given procedure to be discussed with all patients. Importantly, they are intended to catalyse discussion of subjective importance to individuals. MAIN BODY: The model described in this paper applies health services research and Delphi consensus-building methods to an idea orginally proposed 30 years ago. The hypothesis is that, first, large amounts of potentially-important information are distilled down to discrete information domains. These are then, secondly, rated by key stakeholders in multiple iterations, so that core information of agreed importance can be defined. We argue that this scientific approach is key to identifying information important to all stakeholders, which may otherwise be communicated poorly or omitted from discussions entirely. Our methods apply systematic review, qualitative, survey and consensus-building techniques to define this 'core information'. We propose that such information addresses the 'reasonable patient' standard for information disclosure but, more importantly, can serve as a spring board for high-value discussion of importance to the individual patient. CONCLUSION: The application of established research methods can define information of core importance to informed consent. Further work will establish how best to incorporate this model in routine practice.

Empathy among undergraduate medical students: A multi-centre cross-sectional comparison of students beginning and approaching the end of their course.

BACKGROUND: Although a core element in patient care the trajectory of empathy during undergraduate medical education remains unclear. Empathy is generally regarded as comprising an affective capacity: the ability to be sensitive to and concerned for, another and a cognitive capacity: the ability to understand and appreciate the other person's perspective. The authors investigated whether final year undergraduate students recorded lower levels of empathy than their first year counterparts, and whether male and female students differed in this respect. METHODS: Between September 2013 and June 2014 an online questionnaire survey was administered to 15 UK, and 2 international medical schools. Participating schools provided both 5-6 year standard courses and 4 year accelerated graduate entry courses. The survey incorporated the Jefferson Scale of Empathy-Student Version (JSE-S) and Davis's Interpersonal Reactivity Index (IRI), both widely used to measure medical student empathy. Participation was voluntary. Chi squared tests were used to test for differences in biographical characteristics of student groups. Multiple linear regression analyses, in which predictor variables were year of course (first/final); sex; type of course and broad socio-economic group were used to compare empathy scores. RESULTS: Five medical schools (4 in the UK, 1 in New Zealand) achieved average response rates of 55 % (n = 652) among students starting their course and 48 % (n = 487) among final year students. These schools formed the High Response Rate Group. The remaining 12 medical schools recorded lower response rates of 24.0 % and 15.2 % among first and final year students respectively. These schools formed the Lower Response Rate Group. For both male and female students in both groups of schools no significant differences in any empathy scores were found between students starting and approaching the end of their course. Gender was found to significantly predict empathy scores, with females scoring higher than males. CONCLUSIONS: Participant male and female medical students approaching the end of their undergraduate education, did not record lower levels of empathy, compared to those at the beginning of their course. Questions remain concerning the trajectory of empathy after qualification and how best to support it through the pressures of starting out in medical practice.

Doctors' perspectives of informed consent for non-emergency surgical procedures: a qualitative interview study.

BACKGROUND: The need to involve patients more in decisions about their care, the ethical imperative and concerns about ligation and complaints has highlighted the issue of informed consent and how it is obtained. In order for a patient to make an informed decision about their treatment, they need appropriate discussion of the risks and benefits of the treatment. OBJECTIVES: To explore doctors' perspectives of gaining informed consent for routine surgical procedures. DESIGN: Qualitative study using semi-structured interviews selected by purposive sampling. Data were analysed thematically. SETTING AND PARTICIPANTS: Twenty doctors in two teaching hospitals in the UK. RESULTS: Doctors described that while consent could be taken over a series of consultations, it was common for consent to be taken immediately prior to surgery. Juniors were often taking consent when they were unfamiliar with the procedure. Doctors used a range of communication techniques to inform patients about the procedure and its risks including quantifying risks, personalizing risk, simplification of language and use of drawings. Barriers to effective consent taking were reported to be shortage of time, clinician inexperience and patients' reluctance to be involved. DISCUSSION AND CONCLUSION: Current consent processes do not appear to be ideal for many doctors. In particular, junior doctors are often not confident taking consent for surgical procedures and require more support to undertake this task. This might include written information for junior staff, observation by senior colleagues when undertaking the task and ward-based communication skills teaching on consent taking.

Measuring clinical skills in agenda-mapping (EAGL-I).

OBJECTIVE: To develop and validate the Evaluation of AGenda-mapping skilL Instrument (EAGL-I). METHODS: EAGL-I was constructed after a literature review and piloting. Simulated consultation recordings were collected in a workshop with third-year medical students at three time points: once pre-teaching, twice post-teaching. Three raters used EAGL-I to assess student agenda-mapping. We examined reliability, ability to detect change and predict full expression of patients' agendas. RESULTS: EAGL-I scores represented reliable assessment of agenda-mapping (Ep(2)=0.832; φ=0.675). Generalizability coefficients across items (Ep(2)=0.836) and raters (φ=0.797 two raters) were acceptable. A one-way repeated measure ANOVA with post hoc analysis found a statistically significant difference between the pre-teaching occasion of measurement and each post-teaching occasion (p<0.001) and no significant difference between the two post-teaching occasions (p=0.085). Multilevel logistic regression show scores predict expression of scripted hidden agendas irrespective of occasions, or patient scenario (n=60, p=0.005). CONCLUSION: Evidence of measure validation is shown. Reliability is optimised when two or more raters use EAGL-I and agenda-mapping has been taught. EAGL-I appears sensitive to change. Higher scores predict the likelihood that a patient will disclose their full agenda in a simulated environment. PRACTICE IMPLICATIONS: A validated tool for measuring agenda-mapping in teaching and research is now available.

What is agenda setting in the clinical encounter? Consensus from literature review and expert consultation.

OBJECTIVE: To establish consensus on the core domains of agenda setting in consultations. METHODS: We reviewed the healthcare literature and, using a modified Delphi technique to embrace both patient and clinician perspectives, conducted an iterative online survey, with 30 experts in health communication. Participants described agenda setting and rated the importance of proposed domains. Consensus was determined where the group median was ≥5 on a 7-point Likert-like response scale, and the interquartile range fell to within one point on this scale. RESULTS: Relevant publications were identified in three overlapping bodies of healthcare literature. Survey respondents considered that agenda setting involved a process whereby patients and clinicians establish a joint focus for both their conversation and their working relationship. Consensus was obtained on six core domains: identifying patient talk topics, identifying clinician talk topics, agreement of shared priorities, establishing conversational focus, collaboration and engagement. New terminology--agenda mapping and agenda navigation--is proposed. CONCLUSION: We identified core agenda setting domains that embraced patient and clinician perspectives. PRACTICE IMPLICATIONS: An integrated conceptualization of agenda setting may now be used by researchers and educators in both clinician and patient focused interventions.

Teaching pediatric communication skills to medical students.

BACKGROUND: Delivering effective clinical pediatric communication skills training to undergraduate medical students is a distinct and important challenge. Pediatric-specific communication skills teaching is complex and under-researched. We report on the development of a scenario-based pediatric clinical communication skills program as well as students' assessment of this module. METHODS: We designed a pediatric clinical communication skills program and delivered it five times during one academic year via small-group teaching. Students were asked to score the workshop in eight domains (learning objectives, complexity, interest, competencies, confidence, tutors, feedback, and discussion) using 5-point Likert scales, along with free text comments that were grouped and analyzed thematically, identifying both the strengths of the workshop and changes suggested to improve future delivery. RESULTS: Two hundred and twenty-one of 275 (80%) student feedback forms were returned. Ninety-six percent of students' comments were positive or very positive, highlighting themes such as the timing of teaching, relevance, group sizes, and the use of actors, tutors, and clinical scenarios. CONCLUSION: Scenario-based teaching of clinical communication skills is positively received by students. Studies need to demonstrate an impact on practice, performance, development, and sustainability of communications training.

Patient safety and communication: a new assessment for doctors trained in countries where language differs from that of the host country: results of a pilot using a domain-based assessment.

OBJECTIVE: Global migration of healthcare workers places responsibility on employers to comply with legal employment rights whilst ensuring patient safety remains the central goal. We describe the pilot of a communication assessment designed for doctors who trained and communicated with patients and colleagues in a different language from that of the host country. It is unique in assessing clinical communication without assessing knowledge. METHODS: A 14-station OSCE was developed using a domain-based marking scheme, covering professional communication and English language skills (speaking, listening, reading and writing) in routine, acute and emotionally challenging contexts, with patients, carers and healthcare teams. Candidates (n=43), non-UK trained volunteers applying to the UK Foundation Programme, were provided with relevant station information prior to the exam. RESULTS: The criteria for passing the test included achieving the pass score and passing 10 or more of the 14 stations. Of the 43 candidates, nine failed on the station criteria. Two failed the pass score and also the station criteria. The Cronbach's alpha coefficient was 0.866. CONCLUSION: This pilot tested 'proof of concept' of a new domain-based communication assessment for non-UK trained doctors. PRACTICE IMPLICATIONS: The test would enable employers and regulators to verify communication competence and safety in clinical contexts, independent of clinical knowledge, for doctors who trained in a language different from that of the host country.

Systematic review and meta-analysis of audio-visual information aids for informed consent for invasive healthcare procedures in clinical practice.

OBJECTIVE: To systematically review audio-visual (AV) interventions for promoting informed consent (IC) in clinical practice and to consider the impact of reading age adjustment. METHODS: Systematic review of randomized controlled trials (RCTs) comparing AV interventions to standard IC in clinical practice. Outcomes included recall (immediate <1 day; intermediate 1-14 days; late >14 days), satisfaction and anxiety. Data were synthesized using random effects meta-analyses. Comparisons were made between studies that did and did not adjust for participant reading age. RESULTS: Of 11,813 abstracts screened, 29 RCTs were eligible (30 intervention arms). Interventions included videos (n=17), computer programs (n=5), electronic presentations (n=3), compact discs (n=3) and websites (n=2). Meta-analysis showed AV interventions improved immediate recall (standardized mean difference [SMD] 0.64, 95% confidence interval [CI] 0.45-0.85). Results for intermediate and late recall were too heterogeneous to synthesize. AV interventions did not consistently affect either satisfaction or anxiety. Adjusting the reading age of interventions improved immediate recall (reading age interventions: adjusted SMD 1.21, 95%CI 0.81-1.61; non-reading age adjusted SMD 0.51, 95%CI 0.36-0.66). CONCLUSION: AV interventions, especially those adjusted for participant reading age, improve immediate information recall for IC. Practice implications Wider use of AV aids is justified when obtaining IC in clinical practice.

Tackling obesity: the challenge of obesity management for practice nurses in primary care.

BACKGROUND: Nurses in primary care, who see a large proportion of the population, are well placed to discuss weight with patients and offer management advice. Interventions to promote weight loss have shown that there are effective ways of making small changes for patients. OBJECTIVES: To use qualitative semi-structured interviews to explore how practice nurses manage obesity within primary care and to identify good practice and explore barriers to achieving effective management. METHODS: Eighteen semi-structured interviews were conducted with practice nurses within two local health board areas in South Wales. Interviews were audio-recorded, transcribed and analysed qualitatively using a thematic approach. RESULTS: Nurses described two roles. One role was providing obesity management to patients who had co-morbid conditions and were seen regularly in chronic disease clinics. All nurses perceived that these patients needed their weight addressing routinely. The other role was to broach the subject with overweight but healthy patients. Nurses were of divided opinion whether to address obesity with these patients and what primary care had to offer. Weight management advice, when given, lacked consistency of approach. CONCLUSIONS: Broaching the subject of weight opportunistically with healthy but overweight patients may require a deeper appreciation of their motivations for change and discussion beyond future health risks. These patients also need clearer follow up to monitor their progress with weight loss. All overweight patients also need clearer guidance tailored to their own particular circumstances as to how to lose weight. For patients being counselled about their weight, interventions that promote consistency of advice are advocated to improve care.

Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures.

BACKGROUND: Achieving informed consent is a core clinical procedure and is required before any surgical or invasive procedure is undertaken.  However, it is a complex process which requires patients be provided with information which they can understand and retain, opportunity to consider their options, and to be able to express their opinions and ask questions.  There is evidence that at present some patients undergo procedures without informed consent being achieved. OBJECTIVES: To assess the effects on patients, clinicians and the healthcare system of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare treatments and procedures. SEARCH METHODS: We searched the following databases using keywords and medical subject headings: Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 5, 2012), MEDLINE (OvidSP) (1950 to July 2011), EMBASE (OvidSP) (1980 to July 2011) and PsycINFO (OvidSP) (1806 to July 2011). We applied no language or date restrictions within the search. We also searched reference lists of included studies. SELECTION CRITERIA: Randomised controlled trials and cluster randomised trials of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. We considered an intervention to be intended to promote informed consent when information delivery about the procedure was enhanced (either by providing more information or through, for example, using new written materials), or if more opportunity to consider or deliberate on the information was provided. DATA COLLECTION AND ANALYSIS: Two authors assessed the search output independently to identify potentially-relevant studies, selected studies for inclusion, and extracted data. We conducted a narrative synthesis of the included trials, and meta-analyses of outcomes where there were sufficient data. MAIN RESULTS: We included 65 randomised controlled trials from 12 countries involving patients undergoing a variety of procedures in hospitals. Nine thousand and twenty one patients were randomised and entered into these studies. Interventions used various designs and formats but the main data for results were from studies using written materials, audio-visual materials and decision aids. Some interventions were delivered before admission to hospital for the procedure while others were delivered on admission.Only one study attempted to measure the primary outcome, which was informed consent as a unified concept, but this study was at high risk of bias.  More commonly, studies measured secondary outcomes which were individual components of informed consent such as knowledge, anxiety, and satisfaction with the consent process.  Important but less commonly-measured outcomes were deliberation, decisional conflict, uptake of procedures and length of consultation.Meta-analyses showed statistically-significant improvements in knowledge when measured immediately after interventions (SMD 0.53 (95% CI 0.37 to 0.69) I(2) 73%), shortly afterwards (between 24 hours and 14 days) (SMD 0.68 (95% CI 0.42 to 0.93) I(2) 85%) and at a later date (15 days or more) (SMD 0.78 (95% CI 0.50 to 1.06) I(2) 82%). Satisfaction with decision making was also increased (SMD 2.25 (95% CI 1.36 to 3.15) I(2) 99%) and decisional conflict was reduced (SMD -1.80 (95% CI -3.46 to -0.14) I(2) 99%). No statistically-significant differences were found for generalised anxiety (SMD -0.11 (95% CI -0.35 to 0.13) I(2) 82%), anxiety with the consent process (SMD 0.01 (95% CI -0.21 to 0.23) I(2) 70%) and satisfaction with the consent process (SMD 0.12 (95% CI -0.09 to 0.32) I(2) 76%). Consultation length was increased in those studies with continuous data (mean increase 1.66 minutes (95% CI 0.82 to 2.50) I(2) 0%) and in the one study with non-parametric data (control 8.0 minutes versus intervention 11.9 minutes, interquartile range (IQR) of 4 to 11.9 and 7.2 to 15.0 respectively). There were limited data for other outcomes.In general, sensitivity analyses removing studies at high risk of bias made little difference to the overall results.  AUTHORS' CONCLUSIONS: Informed consent is an important ethical and practical part of patient care.  We have identified efforts by researchers to investigate interventions which seek to improve information delivery and consideration of information to enhance informed consent.  The interventions used consistently improve patient knowledge, an important prerequisite for informed consent.  This is encouraging and these measures could be widely employed although we are not able to say with confidence which types of interventions are preferable. Our results should be interpreted with caution due to the high levels of heterogeneity associated with many of the main analyses although we believe there is broad evidence of beneficial outcomes for patients with the pragmatic application of interventions. Only one study attempted to measure informed consent as a unified concept.

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

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