Julia Wade

Superhighway to promoting a client-therapist partnership? Using the Internet to deliver word-retrieval computer therapy, monitored remotely with minimal speech and language therapy input.

Background: Advances in information and communications technology have not only made independent speech and language therapy practice using a computer possible, it is now feasible to monitor this therapy from a different location ( “remotely”). Aims: This paper describes an evaluation of whether therapy delivered this way is efficacious and acceptable in improving word‐retrieval and efficient in terms of therapist time. Methods & Procedures: Seven participants were recruited to a case series study, with an ABA design, where A represented a no‐treatment assessment phase. All were at least 2 years post CVA and had word‐finding difficulties associated with aphasia. Participants had access to therapy software on a home computer. Therapy exercises were updated remotely by a therapist from a clinic computer via the Internet. No face‐to‐face therapy took place. Outcomes & Results: Outcome measures included data on software usage, pre and post‐therapy language assessments, and pre and post‐therapy participant interviews to explore perceived benefits and users views. Results showed intensive use of the system, and improvement in word retrieval skills. Conclusions: Results suggest this mode of therapy delivery is efficacious, acceptable, and gave participants a high degree of independence. Relatively little input in terms of therapist time is required. The findings are discussed in terms of implications for therapy delivery for people with aphasia.

Psychological impact of prostate biopsy: physical symptoms, anxiety, and depression.

PURPOSE To investigate the psychological impact of prostate biopsy, including relationships between physical biopsy-related symptoms and anxiety and depression. PATIENTS AND METHODS A prospective cohort of 1,147 men, nested within the Prostate Testing for Cancer and Treatment trial and recommended to receive prostate biopsy, completed questionnaires assessing physical and psychological harms after biopsy in the Prostate Biopsy Effects study. Psychological impact was measured using the Hospital Anxiety and Depression Scale, and scores were compared according to experiences of biopsy-related symptoms at biopsy, and at 7 and 35 days afterward, and in relation to biopsy results. RESULTS A total of 1,144 men (99.7%) returned questionnaires at biopsy, with 1,090 (95.0%) and 1,016 (88.6%) responding at 7 and 35 days postbiopsy. Most men experienced biopsy-related symptoms as no problem or a minor problem, and overall levels of anxiety and depression were low and similar to normative levels. Of men receiving a negative biopsy result (n = 471), anxiety was greater in those experiencing problematic biopsy-related symptoms compared with those experiencing nonproblematic symptoms at 7 days for the following symptoms: pain (P < .001), shivers, (P = .020), hematuria (P < .001), hematochezia (P < .001), and hemoejaculate (P < .001). Anxiety was reduced, although symptoms were not, after 35 days. Overall levels of anxiety were low across all time points except at the 35-day assessment among men who had received a cancer diagnosis. CONCLUSION Problematic postbiopsy symptoms can lead to increased anxiety, distinct from distress related to diagnosis of prostate cancer. Men and doctors need to consider these additional potential harms of biopsy when deciding whether to initiate prostate-specific antigen testing.

Talk about IT: Views of people with aphasia and their partners on receiving remotely monitored computer‐based word finding therapy

Background: Research into computerised aphasia therapy has investigated effects of computer therapy on language skills. Little is known about views of people with aphasia on using computers in therapy. New technology has made possible delivery of therapy via the Internet ( “remotely”), without face‐to‐face contact with the therapist. The acceptability to clients and carers of this novel mode of delivering aphasia therapy warranted investigation. Aims: This paper reports an exploratory investigation of the views and experiences of six people with aphasia and their partners on receiving computer‐based word‐retrieval therapy delivered remotely. Methods & Procedures: Six people with aphasia received therapy via computer over a 6‐month period. A speech and language therapist monitored therapy remotely via the Internet. In‐depth interviews were carried out with participants and carers after therapy, by a therapist not involved in treatment, to elicit views on expectations, experiences, and effects of therapy. Five men and one woman with aphasia were interviewed (median age 63 years). Participants ranged from 2 to 12 years post CVA (median 2yrs 6 months). All had word retrieval difficulties. Five had partners, all of whom were interviewed. Outcomes & Results: All participants responded positively to this mode of therapy delivery and all perceived gains to have been made. Organisation of practice varied but all reported a sense of increased autonomy for the person with aphasia and believed this mode of therapy had facilitated more intensive practice than previously experienced. Intensity of practice was seen as crucial in leading to benefits at the level of language impairment. Benefits to functional communication were attributed not only to improved language skills but also to improved confidence and self‐esteem. Negative effects all related to amount of time spent in practice and reduced time available for other activities. Conclusions: A wide range of benefits to functional communication was reported from receiving therapy that was purely impairment‐based and involved no face‐to‐face contact with a therapist. Participants valued the increased autonomy and increased opportunity for practice associated with the remotely monitored therapy but viewed the supervisory role of the speech and language therapist as crucial. The remote mode of therapy delivery may offer potential advantages compared with face‐to‐face therapy, which warrant further investigation.

An investigation into the feasibility of remotely monitored computer therapy for people with aphasia

The advent of telecommunications software and increased access to the Web have made feasible delivery of therapy without face-to-face contact between the person receiving therapy and the therapist, that is, remotely. This study investigates the practicalities of remotely monitored therapy for people with aphasia. It reports a case series involving seven participants. All were given access to a computer, modem, and therapy and communications software at home. Progress made in home practice was monitored remotely on a monthly basis by the speech and language therapist, and new exercises were assigned. The study sought to evaluate whether people with aphasia were able and willing to participate in therapy delivered this way, whether transfer of data and new exercises was possible usingexisting technology, and whether this mode of therapy delivery was effective in reducing therapist input in terms of time. Results indicate that this mode of therapy delivery has potential benefits in terms of saving therapy time and increasing intensity of practice for some people with dysphasia. However, benefits were offset by time-consuming processes associated with data transfer. It is therefore recommended that new software be developed to automate such processes to the benefit of both usersand therapists.

Diagnostic Intervals and Its Association with Breast, Prostate, Lung and Colorectal Cancer Survival in England: Historical Cohort Study Using the Clinical Practice Research Datalink

Rapid diagnostic pathways for cancer have been implemented, but evidence whether shorter diagnostic intervals (time from primary care presentation to diagnosis) improves survival is lacking. Using the Clinical Practice Research Datalink, we identified patients diagnosed with female breast (8,639), colorectal (5,912), lung (5,737) and prostate (1,763) cancers between 1998 and 2009, and aged >15 years. Presenting symptoms were classified as alert or non-alert, according to National Institute for Health and Care Excellence guidance. We used relative survival and excess risk modeling to determine associations between diagnostic intervals and five-year survival. The survival of patients with colorectal, lung and prostate cancer was greater in those with alert, compared with non-alert, symptoms, but findings were opposite for breast cancer. Longer diagnostic intervals were associated with lower mortality for colorectal and lung cancer patients with non-alert symptoms, (colorectal cancer: Excess Hazards Ratio, EHR >6 months vs <1 month: 0.85; 95% CI: 0.72-1.00; Lung cancer: EHR 3-6 months vs <1 month: 0.87; 95% CI: 0.80-0.95; EHR >6 months vs <1 month: 0.81; 95% CI: 0.74-0.89). Prostate cancer mortality was lower in patients with longer diagnostic intervals, regardless of type of presenting symptom. The association between diagnostic intervals and cancer survival is complex, and should take into account cancer site, tumour biology and clinical practice. Nevertheless, unnecessary delay causes patient anxiety and general practitioners should continue to refer patients with alert symptoms via the cancer pathways, and actively follow-up patients with non-alert symptoms in the community.

The importance of dietary change for men diagnosed with and at risk of prostate cancer: a multi-centre interview study with men, their partners and health professionals

BackgroundThe diagnosis of prostate cancer (PC) can provide a trigger for dietary change, and there is evidence that healthier diets may improve quality of life and clinical outcomes. However, men’s views about dietary change in PC survivorship are largely unknown. This multi-centre qualitative interview study explored men’s views about dietary change in PC survivorship, to better understand motivations for, and barriers to, achieving desired changes. The role of radical and active surveillance treatments on dietary change and the influence of men’s partners were examined. Focus groups also evaluated stakeholder opinion, including healthcare professionals, about the provision of dietary advice to PC patients.MethodsA multi-centre interview study explored views about diet and motivations for, and barriers to, dietary change in men at elevated risk or diagnosed with PC following prostate specific antigen (PSA) testing. 58 men and 11 partners were interviewed. Interviews and focus groups were undertaken with 11 healthcare professionals, 5 patients and 4 partners to evaluate stakeholders’ opinions about the feasibility and acceptability of providing dietary advice to PC patients. Data were analysed using methods of constant comparison and thematic analysis.ResultsOver half of diagnosed men reported making dietary changes, primarily to promote general or prostate health or facilitate coping, despite their uncertainty about diet-PC links. Interest in dietary advice was high. Information needs varied depending on treatment received, with men on active surveillance more frequently modifying their diet and regarding this as an adjunct therapy. Men considered their partners integral to implementing changes. Provision of dietary advice to men diagnosed with PC was considered by healthcare professionals and men to be feasible and appropriate in the context of a holistic ‘care package’.ConclusionsMany men make positive dietary changes after PC diagnosis, which are perceived by men and their partners to bring psychological and general health benefits and could help future dietary intervention trials. Men and their partners desire more and better dietary information that may support PC survivorship, particularly among those embarking on active surveillance/monitoring programmes. There are opportunities for healthcare professionals to support PC patients both clinically and psychologically by the routine integration of healthy eating advice into survivorship care plans.

Conveying Equipoise during Recruitment for Clinical Trials: Qualitative Synthesis of Clinicians’ Practices across Six Randomised Controlled Trials

Background Randomised controlled trials (RCTs) are essential for evidence-based medicine and increasingly rely on front-line clinicians to recruit eligible patients. Clinicians’ difficulties with negotiating equipoise is assumed to undermine recruitment, although these issues have not yet been empirically investigated in the context of observable events. We aimed to investigate how clinicians conveyed equipoise during RCT recruitment appointments across six RCTs, with a view to (i) identifying practices that supported or hindered equipoise communication and (ii) exploring how clinicians’ reported intentions compared with their actual practices. Methods and Findings Six pragmatic UK-based RCTs were purposefully selected to include several clinical specialties (e.g., oncology, surgery) and types of treatment comparison. The RCTs were all based in secondary-care hospitals (n = 16) around the UK. Clinicians recruiting to the RCTs were interviewed (n = 23) to understand their individual sense of equipoise about the RCT treatments and their intentions for communicating equipoise to patients. Appointments in which these clinicians presented the RCT to trial-eligible patients were audio-recorded (n = 105). The appointments were analysed using thematic and content analysis approaches to identify practices that supported or challenged equipoise communication. A sample of appointments was independently coded by three researchers to optimise reliability in reported findings. Clinicians and patients provided full written consent to be interviewed and have appointments audio-recorded. Interviews revealed that clinicians’ sense of equipoise varied: although all were uncertain about which trial treatment was optimal, they expressed different levels of uncertainty, ranging from complete ambivalence to clear beliefs that one treatment was superior. Irrespective of their personal views, all clinicians intended to set their personal biases aside to convey trial treatments neutrally to patients (in accordance with existing evidence). However, equipoise was omitted or compromised in 48/105 (46%) of the recorded appointments. Three commonly recurring practices compromised equipoise communication across the RCTs, irrespective of clinical context. First, equipoise was overridden by clinicians offering treatment recommendations when patients appeared unsure how to proceed or when they asked for the clinician’s expert advice. Second, clinicians contradicted equipoise by presenting imbalanced descriptions of trial treatments that conflicted with scientific information stated in the RCT protocols. Third, equipoise was undermined by clinicians disclosing their personal opinions or predictions about trial outcomes, based on their intuition and experience. These broad practices were particularly demonstrated by clinicians who had indicated in interviews that they held less balanced views about trial treatments. A limitation of the study was that clinicians volunteering to take part in the research might have had a particular interest in improving their communication skills. However, the frequency of occurrence of equipoise issues across the RCTs suggests that the findings are likely to be reflective of clinical recruiters’ practices more widely. Conclusions Communicating equipoise is a challenging process that is easily disrupted. Clinicians’ personal views about trial treatments encroached on their ability to convey equipoise to patients. Clinicians should be encouraged to reflect on personal biases and be mindful of the common ways in which these can arise in their discussions with patients. Common pitfalls that recurred irrespective of RCT context indicate opportunities for specific training in communication skills that would be broadly applicable to a wide clinical audience.

A Peer Review Intervention for Monitoring and Evaluating sites (PRIME) that improved randomized controlled trial conduct and performance

OBJECTIVE Good clinical practice (GCP) guidelines emphasize trial site monitoring, although the implementation is unspecified and evidence for benefit is sparse. We aimed to develop a site monitoring process using peer reviewers to improve staff training, site performance, data collection, and GCP compliance. STUDY DESIGN AND SETTING The Peer Review Intervention for Monitoring and Evaluating sites (PRIME) team observed and gave feedback on trial recruitment and follow-up appointments, held staff meetings, and examined documentation during annual 2-day site visits. The intervention was evaluated in the ProtecT trial, a UK randomized controlled trial of localized prostate cancer treatments (ISRCTN20141297). The ProtecT coordinator and senior nurses conducted three monitoring rounds at eight sites (2004-2007). The process evaluation used PRIME report findings, trial databases, resource use, and a site nurse survey. RESULTS Adverse findings decreased across all sites from 44 in round 1 to 19 in round 3. Most findings related to protocol adherence or site organizational issues, including improvements in eligibility criteria application and data collection. Staff found site monitoring acceptable and made changes after reviews. CONCLUSION The PRIME process used observation by peer reviewers to improve protocol adherence and train site staff, which increased trial performance and consistency.

The association of waiting times from diagnosis to surgery with survival in women with localised breast cancer in England.

Background:Survival from breast cancer in the United Kingdom is lower than in other developed countries. It is unclear to what extent waiting times for curative surgery affect survival.Methods:Using national databases for England (cancer registries, Hospital Episode Statistics and Office of National Statistics), we identified 53 689 women with localised breast cancer, aged ⩾15 years, diagnosed between 1996 and 2009, who had surgical resection with curative intent within 62 days of diagnosis. We used relative survival and excess risk modelling to determine associations between waiting times and 5-year survival.Results:The median diagnosis to curative surgery waiting time among breast cancer patients was 22 days (interquartile range (IQR): 15–30). Relative survival was similar among women waiting between 25 and 38 days (RS: 93.5%; 95% CI: 92.8–94.2%), <25 days (RS: 93.0%; 95% CI: 92.5–93.4%) and between 39 and 62 days (RS: 92.1%; 95% CI: 90.8–93.4%). There was little evidence of an increase in excess mortality with longer waiting times (excess hazard ratio (EHR): 1.06; 95% CI: 0.88–1.27 comparing waiting times 39-62 with 25–38 days). Excess mortality was associated with age (EHR 65–74 vs 15–44 year olds: 1.23; 95% CI: 1.07–1.41) and deprivation (EHR most vs least deprived: 1.28; 95% CI: 1.09–1.49), but waiting times did not explain these differences.Conclusion:Within 62 days of diagnosis, decreasing waiting times from diagnosis to surgery had little impact on survival from localised breast cancer.

Establishing nurse-led active surveillance for men with localised prostate cancer: development and formative evaluation of a model of care in the ProtecT trial.

Objectives To develop a nurse-led, urologist-supported model of care for men managed by active surveillance or active monitoring (AS/AM) for localised prostate cancer and provide a formative evaluation of its acceptability to patients, clinicians and nurses. Nurse-led care, comprising an explicit nurse-led protocol with support from urologists, was developed as part of the AM arm of the Prostate testing for cancer and Treatment (ProtecT) trial. Design Interviews and questionnaire surveys of clinicians, nurses and patients assessed acceptability. Setting Nurse-led clinics were established in 9 centres in the ProtecT trial and compared with 3 non-ProtecT urology centres elsewhere in UK. Participants Within ProtecT, 22 men receiving AM nurse-led care were interviewed about experiences of care; 11 urologists and 23 research nurses delivering ProtecT trial care completed a questionnaire about its acceptability; 20 men managed in urology clinics elsewhere in the UK were interviewed about models of AS/AM care; 12 urologists and three specialist nurses working in these clinics were also interviewed about management of AS/AM. Results Nurse-led care was commended by ProtecT trial participants, who valued the flexibility, accessibility and continuity of the service and felt confident about the quality of care. ProtecT consultant urologists and nurses also rated it highly, identifying continuity of care and resource savings as key attributes. Clinicians and patients outside the ProtecT trial believed that nurse-led care could relieve pressure on urology clinics without compromising patient care. Conclusions The ProtecT AM nurse-led model of care was acceptable to men with localised prostate cancer and clinical specialists in urology. The protocol is available for implementation; we aim to evaluate its impact on routine clinical practice. Trial registration numbers NCT02044172; ISRCTN20141297.