The importance of cancer prevention policies to inform and guide preventative and screening measures for people with intellectual disabilities: The COST project "Cancer- Understanding Prevention in Intellectual Disabilities".

Cancer is a global public health problem, but its exact prevalence in people with intellectual disabilities is still uncertain. This population, with limited health skills and complex health needs, faces many challenges in cancer prevention, screening, timely diagnosis and treatment. Furthermore, they are often underrepresented in general cancer prevention and screening policies across Europe, leading to widened disparities in health outcomes and premature mortality. Thus, unified national and local policies are needed to reduce inequalities and promoting a pan-European inclusion of people with intellectual disabilities. Our goal is to raise public awareness of this issue, including the involvement of people with intellectual disabilities, and promote engagement from relevant stakeholders. The COST Action 'Cancer- Understanding Prevention in Intellectual Disabilities' (CUPID) project will address health inequalities faced by people with intellectual disabilities in relation to cancer, and support the development of policy recommendations specifically tailored to their unique cognitive and healthcare needs, having a positive long-term impact on quality of life.

Rehabilitation strategies following oesophagogastric and Hepatopancreaticobiliary cancer (ReStOre II): a protocol for a randomized controlled trial.

BACKGROUND: Curative treatment for upper gastrointestinal (UGI) and hepatopancreaticobiliary (HPB) cancers, involves complex surgical resection often in combination with neoadjuvant/adjuvant chemo/chemoradiotherapy. With advancing survival rates, there is an emergent cohort of UGI and HPB cancer survivors with physical and nutritional deficits, resultant from both the cancer and its treatments. Therefore, rehabilitation to counteract these impairments is required to maximise health related quality of life (HRQOL) in survivorship. The initial feasibility of a multidisciplinary rehabilitation programme for UGI survivors was established in the Rehabilitation Strategies following Oesophago-gastric Cancer (ReStOre) feasibility study and pilot randomised controlled trial (RCT). ReStOre II will now further investigate the efficacy of that programme as it applies to a wider cohort of UGI and HPB cancer survivors, namely survivors of cancer of the oesophagus, stomach, pancreas, and liver. METHODS: The ReStOre II RCT will compare a 12-week multidisciplinary rehabilitation programme of supervised and self-managed exercise, dietary counselling, and education to standard survivorship care in a cohort of UGI and HPB cancer survivors who are > 3-months post-oesophagectomy/ gastrectomy/ pancreaticoduodenectomy, or major liver resection. One hundred twenty participants (60 per study arm) will be recruited to establish a mean increase in the primary outcome (cardiorespiratory fitness) of 3.5 ml/min/kg with 90% power, 5% significance allowing for 20% drop out. Study outcomes of physical function, body composition, nutritional status, HRQOL, and fatigue will be measured at baseline (T0), post-intervention (T1), and 3-months follow-up (T2). At 1-year follow-up (T3), HRQOL alone will be measured. The impact of ReStOre II on well-being will be examined qualitatively with focus groups/interviews (T1, T2). Bio-samples will be collected from T0-T2 to establish a national UGI and HPB cancer survivorship biobank. The cost effectiveness of ReStOre II will also be analysed. DISCUSSION: This RCT will investigate the efficacy of a 12-week multidisciplinary rehabilitation programme for survivors of UGI and HPB cancer compared to standard survivorship care. If effective, ReStOre II will provide an exemplar model of rehabilitation for UGI and HPB cancer survivors. TRIAL REGISTRATION: The study is registered with ClinicalTrials.gov, registration number: NCT03958019, date registered: 21/05/2019.

Non-attendance at urgent referral appointments for suspected cancer: a qualitative study to gain understanding from patients and GPs.

BACKGROUND: The 2-week-wait urgent referral policy in the UK has sought to improve cancer outcomes by accelerating diagnosis and treatment. However, around 5-7% of symptomatic referred patients cancel or do not attend their hospital appointment. While subsequent cancer diagnosis was less likely in non-attenders, those with a diagnosis had worse early mortality outcomes. AIM: To examine how interpersonal, communication, social, and organisational factors influence a patient's non-attendance. DESIGN AND SETTING: Qualitative study in GP practices in one Northern English city. METHOD: In-depth, individual interviews were undertaken face-to-face or by telephone between December 2016 and May 2018, followed by thematic framework analysis. RESULTS: In this study 21 GPs, and 24 patients who did not attend or had cancelled their appointment were interviewed, deriving a range of potential explanations for non-attendance, including: system flaws; GP difficulties with booking appointments; patient difficulties with navigating the appointment system, particularly older patients and those from more deprived areas; patients leading 'difficult lives'; and patients' expectations of the referral, informed by their beliefs, circumstances, priorities, and the perceived prognosis. GPs recognised the importance of communication with the patient, particularly the need to tailor communication to perceived patient understanding and anxiety. GPs and practices varied in their responses to patient non-attendance, influenced by time pressures and perceptions of patient responsibility. CONCLUSION: Failure to be seen within 2 weeks of urgent referral resulted from a number of patient and provider factors. The urgent referral process in general practice and cancer services should accommodate patient perceptions and responses, facilitate referral and attendance, and enable responses to patient non-attendance.

Non-attendance at urgent referral appointments for suspected cancer: a qualitative study to gain understanding from patients and GPs.

BACKGROUND: The 2-week-wait urgent referral policy in the UK has sought to improve cancer outcomes by accelerating diagnosis and treatment. However, around 5-7% of symptomatic referred patients cancel or do not attend their hospital appointment. While subsequent cancer diagnosis was less likely in non-attenders, those with a diagnosis had worse early mortality outcomes. AIM: To examine how interpersonal, communication, social, and organisational factors influence a patient's non-attendance. DESIGN AND SETTING: Qualitative study in GP practices in one Northern English city. METHOD: In-depth, individual interviews were undertaken face-to-face or by telephone between December 2016 and May 2018, followed by thematic framework analysis. RESULTS: In this study 21 GPs, and 24 patients who did not attend or had cancelled their appointment were interviewed, deriving a range of potential explanations for non-attendance, including: system flaws; GP difficulties with booking appointments; patient difficulties with navigating the appointment system, particularly older patients and those from more deprived areas; patients leading 'difficult lives'; and patients' expectations of the referral, informed by their beliefs, circumstances, priorities, and the perceived prognosis. GPs recognised the importance of communication with the patient, particularly the need to tailor communication to perceived patient understanding and anxiety. GPs and practices varied in their responses to patient non-attendance, influenced by time pressures and perceptions of patient responsibility. CONCLUSION: Failure to be seen within 2 weeks of urgent referral resulted from a number of patient and provider factors. The urgent referral process in general practice and cancer services should accommodate patient perceptions and responses, facilitate referral and attendance, and enable responses to patient non-attendance.

Patient non-attendance at urgent referral appointments for suspected cancer and its links to cancer diagnosis and one year mortality: A cohort study of patients referred on the Two Week Wait pathway.

BACKGROUND: The 'Two Week Wait' policy aims to ensure patients with suspected cancer are seen within two weeks of referral. However, patient non-attendance can result in this target being missed. This study aimed to identify predictors of non-attendance; and analyse the relationship between attendance and outcomes including cancer diagnosis and early mortality. METHODS: A cohort study of 109,433 adults registered at 105 general practices, referred to a cancer centre within a large NHS hospital trust (April 2009 to December 2016) on the 'Two Week Wait' pathway. RESULTS: 5673 (5.2%) patients did not attend. Non-attendance was largely predicted by patient factors (younger and older age, male gender, greater deprivation, suspected cancer site, earlier year of referral, greater distance to the hospital) over practice factors (greater deprivation, lower Quality and Outcomes Framework score, lower cancer conversion rate, lower cancer detection rate). 10,360 (9.6%) patients were diagnosed with cancer within six months of referral (9.8% attending patients, 5.6% non-attending patients). Among these patients, 2029 (19.6%) died within 12 months of diagnosis: early mortality risk was 31.3% in non-attenders and 19.2% in attending patients. CONCLUSIONS: Non-attendance at urgent referral appointments for suspected cancer involves a minority of patients but happens in predictable groups. Cancer diagnosis was less likely in non-attending patients but these patients had worse early mortality outcomes than attending patients. The study findings have implications for cancer services and policy.

Patient and family co-developed participant information to improve recruitment rates, retention, and patient understanding in the Rehabilitation Strategies Following Oesophago-gastric and Hepatopancreaticobiliary Cancer (ReStOre II) trial: Protocol for a study within a trial (SWAT).

Background: Whilst the potential benefits of exercise rehabilitation in cancer survivorship are plentiful, recruitment to survivorship rehabilitation trials remains suboptimal. There is growing evidence that Public and Patient Involvement (PPI) initiatives can increase the rate of recruitment to research. This study within a trial (SWAT) will examine if participant information co-developed by patients and their families can lead to greater recruitment rates, retention and understanding of the Rehabilitation Strategies in Oesophago-gastric and Hepatopancreaticobiliary Cancer (ReStOre II) trial when compared to standard participant information. Methods: This SWAT will be carried out over two phases. Phase I will utilise qualitative methods to develop (Phase Ia) and refine (Phase Ib) the new participant information. Phase Ia will recruit up to 20 survivors of upper gastrointestinal or hepatopancreaticobiliary cancer, or their family members, to take part in a focus group or interview to develop the new participant information. Focus groups/interviews will be recorded, transcribed verbatim and analysed thematically. In Phase Ib, participants will return for a second focus group/interview to refine the participant information. Once finalised, the participant information will be submitted to ethics for approval. In Phase II, potential participants for the ReStOre II trial will be randomly assigned to receive either the standard or patient and family co-developed participant information. The two forms of participant information will be compared by recruitment and retention rates, and participant understanding of the trial (Decision-Making Questionnaire). Discussion: We anticipate that engaging with patients and their families to develop participant information will help to increase patient understanding of the ReStOre II trial and therefore recruitment and retention rates. The results of this SWAT will indicate the usefulness of this strategy for optimising recruitment to exercise rehabilitation trials in cancer survivorship. Registration: SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store ( SWAT-100). ReStOre II: ClinicalTrials.gov ( NCT03958019).

The effect of optimised patient information materials on recruitment in a lung cancer screening trial: an embedded randomised recruitment trial.

BACKGROUND: Written participant information materials are important for ensuring that potential trial participants receive necessary information so that they can provide informed consent. However, such materials are frequently long and complex, which may negatively impact patient understanding and willingness to participate. Improving readability, ease of comprehension and presentation may assist with improved participant recruitment. The Systematic Techniques for Assisting Recruitment to Trials (MRC START) study aimed to develop and evaluate interventions to improve trial recruitment. This study aimed to assess the effectiveness of an optimised participant information brochure and cover letter developed by MRC START regarding response and participant recruitment rates. METHODS: We conducted a study within a trial (SWAT) embedded in the EarlyCDT Lung Cancer Scotland (ECLS) trial that aimed to assess the effectiveness of a new test in reducing the incidence of patients with late-stage lung cancer at diagnosis compared with standard care. Potential participants approached for ECLS were randomised to receive the original participant information brochure and accompanying letter (control group) or optimised versions of these materials which had undergone user testing and a process of re-writing, re-organisation and professional graphic design (intervention group). The primary outcome was the number of patients recruited to ECLS. The secondary outcome was the proportion of patients expressing an interest in participating in ECLS. RESULTS: In total, 2262 patients were randomised, 1136 of whom were sent the intervention materials and 1126 of whom were sent the control materials. The proportion of patients enrolled and randomised into ECLS was 180 of 1136 (15.8%) in the intervention group and 176 of 1126 (15.6%) in the control group (OR = 1.016, 95% CI, 0.660 to 1.564). The proportion of patients who positively responded to the invitation was 224 of 1136 (19.7%) in the intervention group and 205 of 1126 (18.2%) in the control group (OR = 1.103, 95% CI, 0.778 to 1.565). CONCLUSIONS: Optimised patient information materials made little difference to the proportion of patients positively responding to a trial invitation or to the proportion subsequently randomised to the host trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01925625 . Registered on 15 August 2015. Study Within A Trial, SWAT-23. Registered on 12 April 2016.

Combined verbal and numerical expressions increase perceived risk of medicine side-effects: a randomized controlled trial of EMA recommendations.

BACKGROUND: The study evaluated European Medicines Agency (EMA) recommendations on communicating frequency information on side-effect risk. METHODS: The study used a 2 × 2 factorial trial, with random allocation of information about 10 side-effects of paclitaxel (Taxol) expressed using one of four formats. Recruitment was via the CancerHelpUK website. Information was conveyed using numerical frequency bands (e.g. 'may affect up to 1 in 10 people') or combined verbal terms and numerical bands (e.g. 'common: may affect up to 1 in 10 people'); in addition, the risk qualifier verb was manipulated, with risks expressed either as 'will affect…' or 'may affect…'. Participants then made six side-effect frequency estimates indicated their satisfaction with the information and evaluated the side-effects: how bad; how likely; how risky to health; and their influence on taking paclitaxel. RESULTS: The sample comprised 339 people, of whom 37.5% had cancer. The combined verbal and numerical risk expressions resulted in higher estimates of side-effects, four of which reached statistical significance (P < 0.05), and participants also said that side-effects would be more likely. Use of 'may affect' or 'will affect' did not result in differences in any estimates. CONCLUSIONS: This is the first evaluation of the full range of combined verbal and numerical risk expressions recommended in EMA guidance; it demonstrates that they can lead to significant risk overestimations when compared to numerical frequency bands alone. The EMA should consider revising its guidance. Government agencies and professional bodies should be cautious about recommendations for risk communication in the absence of empirical evidence.

Practice based collaboration to improve the use of immediate intravesical therapy after resection of nonmuscle invasive bladder cancer.

PURPOSE: Perioperative instillation of intravesical chemotherapy after bladder tumor resection is supported by level I evidence showing a 30% decrease in tumor recurrence. However, studies of administrative data sets show poor use in practice. MATERIALS AND METHODS: We prospectively evaluated the use of perioperative intravesical chemotherapy in a multipractice quality improvement collaborative. Cases were categorized as ideal for intravesical chemotherapy (1 or 2 papillary tumors, cTa/cT1 and completely resected) and nonideal. The reasons for not administering intravesical chemotherapy in ideal cases were classified as appropriate or modifiable. Before and after comparative feedback and educational interventions we calculated judicious use of intravesical chemotherapy (nonuse in nonideal cases plus use in ideal cases plus appropriate nonuse in ideal cases) and quality improvement potential (use in nonideal cases plus nonuse in ideal cases attributable to modifiable factors). RESULTS: We accrued a total of 2,794 cases at the 5 sites in 22 months. The rate of use in ideal cases was 38% before and 34.8% after intervention (p=0.36), while use in nonideal cases decreased from 15% to 12% (p=0.08). Overall, intravesical chemotherapy was used judiciously in 83.0% to 85.7% of cases, while the remaining 14.3% to 17.0% represented quality improvement potential. CONCLUSIONS: Judicious use of perioperative intravesical chemotherapy is relatively high in routine practice. Most instances of nonuse represent appropriate clinical judgment. Utilization did not change after quality improvement interventions, suggesting that there may a ceiling effect that makes it difficult to improve care that is high quality at baseline. Moreover, decreasing unnecessary use of an intervention may be easier than encouraging appropriate use of potentially toxic therapy.

Evaluating a combined (frequency and percentage) risk expression to communicate information on medicine side effects to patients.

OBJECTIVES: The study evaluated the interpretation of, and preferences for, numerical information on side-effect incidence when presented in three different formats. METHODS: It used a controlled design, with participants allocated at random to receive one of the three formats. Participants were recruited via a pop-up window on the CancerHelp UK website. The sample comprised 129 website users, of whom 96% were women and 86% had cancer, who received frequency information on four side effects of tamoxifen, using one of three risk expressions (percentages, e.g. 'affects 25% of people'; frequencies, e.g. 'affects 1 in 4 people'; combined, e.g. 'affects 1 in 4 people (25%)'). They then interpreted information on tamoxifen and its effect on health, and estimates of side-effect frequency, and then stated a preference from the three risk expression formats. KEY FINDINGS: The results showed that the three formats did not influence participants' ratings of the information or their side-effect estimates. However, more than half (53%) the participants preferred the combined (frequency and percentage) format. In conclusion, a combined risk expression format performed no worse than percentages or frequencies alone and was preferred by a majority. CONCLUSIONS: The three risk expression formats did not differ in their effect on participants' interpretations. However, the preferred format was the combined (frequency and percentage) risk expression.

Understanding the use of immediate intravesical chemotherapy for patients with bladder cancer.

PURPOSE: Despite its established efficacy in reducing recurrence rates for patients with urothelial carcinoma, immediate intravesical chemotherapy is reportedly used infrequently. Accordingly, the Urological Surgery Quality Collaborative implemented a project aimed at understanding and improving the use of immediate intravesical chemotherapy. MATERIALS AND METHODS: Surgeons in 5 Urological Surgery Quality Collaborative practices prospectively collected clinical and baseline intravesical chemotherapy use data for patients undergoing bladder biopsy or transurethral bladder tumor resection from September 2010 through January 2012. In the second phase of data collection (June 2011 through January 2012) treating surgeons also documented reasons for not administering intravesical chemotherapy. We defined patients with 1 to 2 clinical stage Ta/T1, completely resected, papillary tumor(s) as ideal candidates for treatment with immediate intravesical chemotherapy. For ideal and nonideal patients we examined baseline use of intravesical chemotherapy across Urological Surgery Quality Collaborative practices as well as reasons for not administering therapy among ideal patients. RESULTS: Among 1,931 patients 37.2% met criteria as ideal cases for intravesical chemotherapy administration. We observed significant variation in the use of intravesical chemotherapy across Urological Surgery Quality Collaborative practices for ideal (range 27% to 50%) and nonideal cases (9% to 24%) (p <0.001). Reasons for not treating ideal candidates included lack of confirmation of malignancy (4, 2.8%), uncertainty regarding the benefits of intravesical chemotherapy (28, 19.6%) and logistic factors such as the unavailability of medication (34, 23.8%). CONCLUSIONS: Use of immediate intravesical chemotherapy by Urological Surgery Quality Collaborative practices is higher than reported elsewhere but still varies widely, even among ideal candidates. Efforts to optimize use will be aided by disseminating evidence supporting indications and benefits of intravesical chemotherapy, and by addressing local logistic factors that limit access to this evidence-based therapy.

Regional collaboration to improve radiographic staging practices among men with early stage prostate cancer.

PURPOSE: We describe findings from a Urological Surgery Quality Collaborative project focused on improving the use of radiographic staging in men with newly diagnosed prostate cancer. MATERIALS AND METHODS: From May 2009 through September 2010 Urological Surgery Quality Collaborative surgeons collected uniform data for men with newly diagnosed prostate cancer. During this period we implemented 3 phases of data collection. Unlike the baseline phase, the second and third rounds were preceded by collaborative quality improvement interventions, including comparative performance feedback, and review and dissemination of clinical guidelines. We evaluated the use of bone scans and computerized tomography across prostate cancer risk strata, Urological Surgery Quality Collaborative practice locations, and before and after quality improvement interventions. RESULTS: We collected data for 858 men with prostate cancer. Based on the D'Amico classification 44%, 39% and 17% of the men had low, intermediate and high risk cancer, respectively. Overall 25% and 22% of patients underwent staging with a bone scan or computerized tomography, respectively, ordered by a Urological Surgery Quality Collaborative urologist. Urological Surgery Quality Collaborative practices differed significantly in their baseline use of bone scans and computerized tomography for men with low and intermediate risk cancer (p<0.01). Compared with baseline practice patterns (31% bone scans, 28% computerized tomography), urologists in Urological Surgery Quality Collaborative practices ordered fewer bone and computerized tomography scans in post-intervention phases 2 (23%, 21%) and 3 (16%, 13%) of data collection (p<0.01), including a significant reduction in the use of these studies in patients with low and intermediate risk cancer (p<0.05). CONCLUSIONS: Following collaborative feedback on baseline use and review of clinical guidelines, urologists in Urological Surgery Quality Collaborative practices dramatically reduced variations in practice patterns and improved adherence with recommended staging practices.

Can user testing of a clinical trial patient information sheet make it fit-for-purpose?--a randomized controlled trial.

BACKGROUND: The participant information sheet (PIS) provided to potential trial participants is a critical part of the process of valid consent. However, there is long-standing concern that these lengthy and complex documents are not fit-for-purpose. This has been supported recently through the application of a performance-based approach to testing and improving readability called user testing. This method is now widely used to improve patient medicine leaflets--determining whether people can find and understand key facts. This study applied for the first time a controlled design to determine whether a PIS developed through user testing had improved readability over the original, using a sheet from a UK trial in acute myeloid leukemia (AML16). METHODS: In the first phase the performance of the original PIS was tested on people in the target group for the trial. There were three rounds of testing including 50 people in total--with the information revised according to its performance after each of the first 2 rounds. In the second phase, the revised PIS was compared with the original in a parallel groups randomised controlled trial (RCT) A total of 123 participants were recruited and randomly allocated to read one version of the PIS to find and show understanding of 21 key facts. RESULTS: The first, developmental phase produced a revised PIS significantly altered in its wording and layout. In the second, trial phase 66% of participants who read the revised PIS were able to show understanding of all aspects of the trial, compared with 15% of those reading the original version (Odds Ratio 11.2; Chi-square = 31.5 p < .001). When asked to state a preference, 87.1% participants chose the revised PIS (Sign test p < .001). CONCLUSIONS: The original PIS for the AML16 trial may not have enabled valid consent. Combining performance-based user testing with expertise in writing for patients and information design led to a significantly improved and preferred information sheet. User testing is an efficient method for indicating strengths and weaknesses in trial information, and Research Ethics Committees and Institutional Review Boards should consider requesting such testing, to ensure that PIS are fit-for-purpose.

The effect of numeracy on the comprehension of information about medicines in users of a patient information website.

OBJECTIVE: To investigate the relationship between numeracy and the accuracy of side effect risk estimation following the presentation of information about a medicine via the Cancer Research UK (CR-UK) patient information website. METHODS: 591 website users were presented with information in different formats about the risks of side effects from taking tamoxifen. Participants estimated the risk of each side effect, provided other subjective ratings about the information and completed a numeracy task. RESULTS: Regardless of presentation format, numeracy was correlated with the accuracy of three side effect risk estimates. People with cancer and tamoxifen users showed stronger correlations for all side effect estimates. In addition, numeracy was positively related to the perceived influence of the information on the decision to take the medicine and was negatively related to ratings of satisfaction with the information. CONCLUSION: People with a lower numeracy level make larger errors in interpreting medicines side effect risk information. PRACTICE IMPLICATIONS: Pharmacists, other health professionals and patient information websites should ensure they provide clear explanations of risk, particularly to people with low numeracy, and assess their understanding of those explanations. Future research into risk communication should take account of numeracy level, to investigate the impact of different formats.

Establishment of a urological surgery quality collaborative.

PURPOSE: We describe the establishment of the Urological Surgery Quality Collaborative including our pilot project to improve radiographic staging for men with prostate cancer. MATERIALS AND METHODS: The Urological Surgery Quality Collaborative comprises more than 60 urologists from 3 group practices. From May through September 2009 Urological Surgery Quality Collaborative surgeons collected a uniform set of data (eg prostate specific antigen, clinical stage) for men with newly diagnosed prostate cancer. After categorizing the cancer of each patient as low, intermediate or high risk, we analyzed baseline use of staging studies across prostate cancer risk strata and Urological Surgery Quality Collaborative practice locations. RESULTS: Of 215 men with prostate cancer 34%, 42% and 24% had low, intermediate and high risk cancer, respectively. Overall 44% and 43% of patients underwent staging with a bone scan or computerized tomography, respectively, and only 9% and 7% of these studies, respectively, were positive for metastases. Use of staging studies increased across risk strata as bone scans or computerized tomography were performed in 17% and 18%, 41% and 40%, and 88% and 86% of patients, respectively, with low, intermediate and high risk tumors (p<0.01). For men with low risk prostate cancer the use of bone scans and computerized tomography differed significantly across Urological Surgery Quality Collaborative practices (p<0.01) and for this group only 1 bone scan (and no computerized tomography) was positive for metastases. CONCLUSIONS: Use of staging evaluations varies by prostate cancer risk strata and across Urological Surgery Quality Collaborative practices. By feeding these data back to surgeons we may be able to improve practice patterns and avoid unnecessary studies in low risk patients. Attainment of this goal would establish the Urological Surgery Quality Collaborative as a viable infrastructure for collaborative quality improvement in urology.

Perceived risk of tamoxifen side effects: a study of the use of absolute frequencies or frequency bands, with or without verbal descriptors.

OBJECTIVE: To investigate the effectiveness of presenting medicine side effect risk information in different forms, including that proposed by UK guidelines [[1] Medicines and Healthcare products Regulatory Agency. Always read the leaflet-Getting the best information with every medicine. (Report of the Committee on Safety of Medicines Working Group on Patient Information). London: The Stationery Office, 2005.]. METHODS: 134 Cancer Research UK (CRUK) website users were recruited via a 'pop-up'. Using a 2x2 factorial design, participants were randomly allocated to one of four conditions and asked to: imagine they had to take tamoxifen, estimate the risks of 4 side effects, and indicate a presentation mode preference. RESULTS: Those presented with absolute frequencies demonstrated greater accuracy in estimating 2 of 4 side effects, and of any side effect occurring, than those presented with frequency bands. Those presented with combined descriptors were more accurate at estimating the risk of pulmonary embolism than those presented with numeric descriptors only. CONCLUSION: Absolute frequencies outperform frequency bands when presenting side effect risk information. However, presenting such exact frequencies for every side effect may be much less digestible than all side effects listed under 5 frequency bands. Combined numerical and verbal descriptors may be better than numeric only descriptors when describing infrequent side effects. PRACTICE IMPLICATIONS: Information about side effects should be presented in ways that patients prefer, and which result in most accurate risk estimates.

Communicating the risk of side effects to patients: an evaluation of UK regulatory recommendations.

BACKGROUND: All licensed medicines in the European Union must be provided with a Patient Information Leaflet that includes a list of all known side effects. Among patients who read the leaflet, the side effects section is the most often read. A UK government regulatory publication recommends providing medicine side effect risk information in a combined format, using verbal descriptors accompanied by numerical information. OBJECTIVES: This study, with users of an existing popular patient information website, investigates the effectiveness of presenting medicine side effect risk information in different forms. DESIGN: Participants were randomly allocated to one of the three formats for representing risk information (verbal descriptors, e.g. 'common'; absolute frequencies, e.g. 'less than 1 in 10 people'; and a combination of verbal descriptors and frequency bands, e.g. 'common (affects less than 1 in 10 people)'. METHODS: Participants (n = 187) were recruited from users of the Cancer Research UK patient information website. They were asked to imagine that they had to take a cancer treatment (tamoxifen), estimate the risks of four side effects occurring, and complete Likert scales relating to their satisfaction with the information supplied and perceived likelihood of various outcomes. RESULTS: Those in the absolute frequency format demonstrated greater accuracy in estimating the likelihood of having two of four side effects than the other two formats. They were also more accurate at estimating the likelihood of themselves or the average person having any side effect from taking tamoxifen. Participants in the absolute frequency format rated the risk to health from tamoxifen as lower than those in the other two formats, were more satisfied with the information they received than those in the verbal format, and felt there would be less impact of the information on tamoxifen use than those in the combined format. CONCLUSIONS: These findings fail to confirm that the recommended use of combined descriptors for medicine side effects is unequivocally superior to absolute frequency alone. They also add weight to the growing body of research highlighting the deficiencies in using verbal descriptors for conveying side effect risk, and the strength of using absolute frequency descriptors.

Heart rate variability: an objective measure of autonomic activity and bladder sensations during urodynamics.

AIMS: There are still controversies regarding the reproducibility of cystometric data and no objective measurement of bladder sensations is currently available. Additionally, very little information exists about autonomic activity during standard filling cystometry (FC). The aim of this study was to evaluate the use of heart rate variability (HRV) analysis as a reliable monitor of the autonomic nervous system and objective measure for bladder sensations during FC. METHODS: In a volunteer sample of healthy female subjects a standard FC at 25 ml/min was performed, using an 8 Fr microtip catheter with integrated pressure transducers. During FC, subjects had to indicate first sensation of filling (FSF), first desire to void (FDV) and strong desire to void (SDV). A 3-lead electrocardiogram was continuously recorded. After 5 h all measurements were repeated. Power spectrum analysis was used to analyse HRV, to obtain low frequency (LF) and high frequency (HF) parameters, from which the LF/HF ratio was derived. RESULTS: 12 subjects with a mean age of 23.3 +/- 2.3 years could be included. 11 of 12 subjects completed both measurement sessions. One subjects had to be excluded, due to irritating urethral discomfort following catheterisation. The LF/HF ratio showed a reproducible activation pattern in the healthy subjects with a stable sympathovagal balance until FDV. Before SDV was indicated, the sympathovagal balance started to shift towards sympathetic activation and caused a significant increase in LF/HF. CONCLUSION: HRV analysis seems to be a useful indicator for the general activation pattern of the sympathovagal balance during FC, correlating the intensity of the bladder filling sensation to stress and sympathetic activation.

Can the ice-water test predict the outcome of intradetrusor injections of botulinum toxin in patients with neurogenic bladder dysfunction?

The aim of this project was to evaluate the ice-water test as a predictor of the response to intradetrusor botulinum toxin injection in patients with neurogenic detrusor overactivity. We retrospectively evaluated the urodynamic parameters in 22 patients with neurogenic bladder dysfunction and positive ice-water test. Maximum cystometric capacity (MCC), reflex volume (RV), maximum detrusor pressure during voiding (MVP) and bladder compliance (BC) were compared before and after intradetrusor injection of 300 units botulinum toxin and calculated as a quotient. The ice-water test was performed before the injection, and the maximum pressure rise and the time to maximum pressure were measured. Furthermore, the ratio between maximum pressure and time to reach maximum pressure was calculated as the velocity of pressure rise. Correlations between the ice-water test criteria and the quotients of the cystometric data before and after injection were determined by the Spearmen's Rho coefficient. The increase in MCC and RV after botulinum toxin A injection showed a small positive, but insignificant correlation of 0.25 and 0.2 to the velocity of pressure rise of the ice-water test. A small negative, but insignificant correlation was found in change of BC and MVP with -0.17 and -0.2, respectively. Based on our population the ice-water test cannot predict the efficacy of intradetrusor botulinum toxin injections in patients with neurogenic detrusor overactivity.

Beyond intention: do specific plans increase health behaviours in patients in primary care? A study of fruit and vegetable consumption.

Increasing evidence suggests that implementation intentions are effective in moving people towards achieving health behaviour goals. However, the type of health behaviours for which they work best is unclear. Furthermore, implementation intentions appear to be less effective when studied in clinical rather than student populations. This prospective study tested implementation intentions with a complex, repeated health behaviour in a patient sample. A total of 120 cardiac patients in the UK were asked to increase their daily fruit and vegetable consumption by two portions and to maintain this over 3 months. Participants were randomly assigned to three groups (control, Theory of Planned Behaviour (TPB) questionnaire, TPB questionnaire+implementation intention) and telephoned at 7, 28 and 90 days follow-up to record daily consumption (24-h recall measure); 94 participants completed the study. Daily fruit and vegetable consumption increased from 2.88 portions (SD=1.67) at recruitment to 4.28 portions (SD=2.25) at 90 days. A 4x3 (time by group) mixed design ANCOVA was computed with daily fruit and vegetable consumption at recruitment entered as a covariate. This revealed a significant time effect (F (3, 270)=29.79, p<0.001) (eta2=0.25) but non-significant group (F (2, 90)=0.32, p=0.73) (eta2=0.07) and time by group effects (F (6, 270)=0.48, p=0.82) (eta2=0.01). There was also a significant main effect of the covariate (F (1, 90)=48.51, p<0.001) (eta2=0.35) and a significant time by covariate effect (F (3, 270)=12.14, p<0.001) (eta2=0.12). Substantial increases in fruit and vegetable consumption were achieved particularly by participants who were eating low levels at recruitment. Consumption was not improved by implementation intentions. These findings are discussed in the context of the targeted health behaviour and sample.