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.

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.

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.

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.

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.

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.

Counselling patients about behaviour change: the challenge of talking about diet.

BACKGROUND: As obesity levels increase, opportunistic behaviour change counselling from primary care clinicians in consultations about healthy eating is ever more important. However, little is known about the approaches clinicians take with patients. AIM: To describe the content of simulated consultations on healthy eating in primary care, and compare this with the content of smoking cessation consultations. DESIGN AND SETTING: Qualitative study of 23 audiotaped simulated healthy eating and smoking cessation consultations between an actor and primary care clinicians (GPs and nurses) within a randomised controlled trial looking at behaviour change counselling. METHOD: Consultations were audiotaped and transcribed verbatim, then analysed inductively using thematic analysis. A thematic framework was developed by all authors and applied to the data. The content of healthy eating consultations was contrasted with that given for smoking cessation. RESULTS: There was a lack of consistency and clarity when clinicians discussed healthy eating compared with smoking; in smoking cessation consultations, the content was clearer to both the clinician and patient. There was a lack of specificity about what dietary changes should be made, how changes could be achieved, and how progress could be monitored. Barriers to change were addressed in more depth within the smoking cessation consultations than within the healthy eating encounters. CONCLUSION: At present, dietary counselling by clinicians in primary care does not typically contain consistent, clear suggestions for specific change, how these could be achieved, and how progress would be monitored. This may contribute to limited uptake and efficacy of dietary counselling in primary care.

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 [rho] = -0.49, P < .001) and lower intention to undergo testing (rho = -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).

A randomised controlled trial of the effects of a web-based PSA decision aid, Prosdex. Protocol.

BACKGROUND: Informed decision making is the theoretical basis in the UK for men's decisions about Prostate Specific Antigen (PSA) testing for prostate cancer testing. The aim of this study is to evaluate the effect of a web-based PSA decision-aid, Prosdex, on informed decision making in men. The objective is to assess the effect of Prosdex on six specific outcomes: (i) knowledge of PSA and prostate cancer-related issues - the principal outcome of the study; (ii) attitudes to testing; (iii) decision conflict; (iv) anxiety; (v) intention to undergo PSA testing; (vi) uptake of PSA testing. In addition, a mathematical simulation model of the effects of Prosdex will be developed. METHODS: A randomised controlled trial with four groups: two intervention groups, one viewing Prosdex and the other receiving a paper version of the site; two control groups, the second controlling for the potential Hawthorn effect of the questionnaire used with the first control group. Men between the ages of 50 and 75, who have not previously had a PSA test, will be recruited from General Practitioners (GPs) in Wales, UK. The principal outcome, knowledge, and four other outcome measures - attitudes to testing, decision conflict, anxiety and intention to undergo testing - will be measured with an online questionnaire, used by men in three of the study groups. Six months later, PSA test uptake will be ascertained from GP records; the online questionnaire will then be repeated. These outcomes, and particularly PSA test uptake, will be used to develop a mathematical simulation model, specifically to consider the impact on health service resources.