A 'combined framework' approach to developing a patient decision aid: the PANDAs model.

BACKGROUND: There is a lack of practical research frameworks to guide the development of patient decision aids [PtDAs]. This paper described how a PtDA was developed using the International Patient Decision Aids (IPDAS) guideline and UK Medical Research Council (UKMRC) frameworks to support patients when making treatment decisions in type 2 diabetes mellitus. METHODS: This study used mixed methods to develop a PtDA for use in a UK general practice setting. A 10-member expert panel was convened to guide development and patients and clinicians were also interviewed individually using semi-structured interview guides to identify their decisional needs. Current literature was reviewed systematically to determine the best available evidence. The Ottawa Decision Support Framework was used to guide the presentation of the information and value clarification exercise. An iterative draft-review-revise process by the research team and review panel was conducted until the PtDA reached content and format 'saturation'. The PtDA was then pilot-tested by users in actual consultations to assess its acceptability and feasibility. The IPDAS and UKMRC frameworks were used throughout to inform the development process. RESULTS: The PANDAs PtDA was developed systematically and iteratively. Patients and clinicians highlighted the needs for information, decisional, emotional and social support, which were incorporated into the PtDA. The literature review identified gaps in high quality evidence and variations in patient outcome reporting. The PtDA comprised five components: background of the treatment options; pros and cons of each treatment option; value clarification exercise; support needs; and readiness to decide. CONCLUSIONS: This study has demonstrated the feasibility of combining the IPDAS and the UKMRC frameworks for the development and evaluation of a PtDA. Future studies should test this model for developing PtDAs across different decisions and healthcare contexts.

Sudden unexpected death in epilepsy: addressing the challenges.

Epilepsy is associated with a higher rate of premature death than the general population, and the commonest cause of epilepsy mortality is sudden unexpected death in epilepsy (SUDEP). It is difficult to quantify because of the variable reporting of this cause of death. Death occurs due to autonomic deregulation of cardio-respiratory pathways as a result of seizures. Measures to reduce cardio-respiratory dysfunction are discussed together with the importance of seizure control in preventing SUDEP. The role of seizure detection devices, antiepileptic drugs and the importance of providing information about SUDEP to people with epilepsy are highlighted. There is increasing interest in SUDEP and some current initiatives are discussed.

Investigating active ingredients in a complex intervention: a nested study within the Patient and Decision Aids (PANDAs) randomised controlled trial for people with type 2 diabetes.

BACKGROUND: Randomised trials provide evidence that patient decision aids improve outcomes with respect to patient knowledge, involvement and satisfaction in decision making. It is less clear how these complex interventions are implemented within patient-clinician interactions and which components are active for improving decision processes. To investigate the experiences of using a diabetes treatment decision aid and to explore how components within a complex intervention influenced the decision making process. METHODS: A pragmatic mixed methods study nested within the PANDAs cluster randomised trial of a patient decision aid. Themes inductively derived from interviews and observation of consultations with further triangulation with results of decision quality and involvement measurements and case analyses. RESULTS: The decision aid intervention was employed flexibly within the consultation with both the patient and clinician active in marshalling elements. The decision aid improved processing and organization of information needed for decision making within the consultation interaction. It also improved decision quality by preparing the patient for active involvement within the clinical consultation. CONCLUSION: The intervention was acceptable, flexible and readily implemented in primary care consultations. The decision aid was effective in facilitating cognitive processing. The intervention also facilitated rehearsal in preparation for active roles in a shared decision process. TRIAL REGISTRATION: Trials Register Number: ISRCTN14842077. Date registered: 24.06.2010.

Preparing breast cancer patients for survivorship (PREP) - a pilot study of a patient-centred supportive group visit intervention.

PURPOSE: The process of breast cancer follow-up has psychosocial benefits for patients, notably reassurance, although attending hospital appointments can increase anxiety. Discharge from hospital follow-up can also invoke anxiety as many patients seek reassurance from continued specialist follow-up. Inevitably, due to increased survival and associated resource issues, opportunities for follow-up and support will be reduced. We delivered and evaluated an intervention which supported the transition from cancer patient to cancer survivor, for breast cancer patients being discharged to primary care. METHODS: We delivered and evaluated a pilot of a patient-centred group intervention 'Preparing Patients for Discharge', aimed at reducing distress. Between January and September 2008, 172 participants were recruited and 74 (43%) expressed an interest in participating in the intervention; 32 of 74 took part, and participated in its evaluation using a semi-structured evaluation questionnaire, standardized measures [Hospital Anxiety and Depression Scale (HADS) and Clinical Outcomes for Routine Evaluation (CORE)] and independent qualitative interviews. RESULTS: The qualitative analysis of questionnaire data indicated key factors were 1) shared experience, 2) support and reassurance, and 3) positive views about cancer and being discharged. The interview data revealed that the intervention enabled participants to: share experiences, focus on emotional needs, and have open discussions about recurrence, while increasing confidence in being discharged and using alternative support services. However, no significant differences were found in pre-post-interventions scores of HADS and CORE. CONCLUSIONS: Providing a structured group intervention approach for breast cancer patients offers an early opportunity to support cancer survivors and facilitate and encourage self-management.

Levels of distress in breast cancer survivors approaching discharge from routine hospital follow-up.

BACKGROUND: Hospital-based breast cancer follow-up provides reassurance to patients despite limited evidence for clinical efficacy. Although alternative models of hospital/community-based follow-up have yielded encouraging results, traditional hospital follow-up continues to be offered to all patients. Survival rates continue to rise; consequently, more patients are likely to require support, as many have a limited understanding of the long-term physical and emotional consequences of cancer and its treatment. We examine levels of psychological distress in breast cancer patients in follow-up 2 years or more from diagnosis. METHODS: This prospective study measured psychological distress levels using standardized measures [Hospital Anxiety and Depression Scale (HADS), Clinical Outcomes for Routine Evaluation (CORE) and Measure Yourself Medical Outcomes Profile (MYMOP)]. Between January and September 2008, 323 consecutive patients were approached in outpatient clinics. Ninety-six patients declined to participate. RESULTS: Two hundred twenty-seven patients took home patient information sheets; 172 (75%) returned completed questionnaires to assess levels of distress (HADS, CORE). MYMOP provided self-reported data on patient symptoms. Patients reported low levels of distress in hospital-based follow-up, which were comparable or better than general population norms, although there was a significant minority of patients reporting high scores (n = 27, 15.7%) on HADS or CORE. There was good agreement between these two measures. All sub-scales of CORE (except risk) correlated well with HADS for anxiety/depression. No significant changes were detected in the standardized measures. MYMOP results showed that 23.8% of respondents reported both physical and emotional symptoms. CONCLUSIONS: Breast cancer survivors reported good psychological outcomes 2 years on from diagnosis. Screening for psychological/emotional distress is a vital part of follow-up care, which should be incorporated into UK policy.

Clinical effectiveness of a patient decision aid to improve decision quality and glycaemic control in people with diabetes making treatment choices: a cluster randomised controlled trial (PANDAs) in general practice.

OBJECTIVE: To determine the effectiveness of a patient decision aid (PDA) to improve decision quality and glycaemic control in people with diabetes making treatment choices using a cluster randomised controlled trial (RCT). DESIGN: A cluster RCT. SETTING: 49 general practices in UK randomised into intervention (n=25) and control (n=24). PARTICIPANTS: General practices Inclusion criteria: >4 medical partners; list size >7000; and a diabetes register with >1% of practice population. 191 practices assessed for eligibility, and 49 practices randomised and completed the study. Patients People with type 2 diabetes mellitus (T2DM) taking at least two oral glucose-lowering drugs with maximum tolerated dose with a glycosolated haemoglobin (HbA1c) greater than 7.4% (IFCC HbA1c >57 mmol/mol) or advised in the preceeding 6 months to add or consider changing to insulin therapy. EXCLUSION CRITERIA: currently using insulin therapy; difficulty reading or understanding English; difficulty in understanding the purpose of the study; visual or cognitive impairment or mentally ill. A total of 182 assessed for eligibility, 175 randomised to 95 intervention and 80 controls, and 167 completion and anlaysis. INTERVENTION: Brief training of clinicians and use of PDA with patients in single consultation. PRIMARY OUTCOMES: Decision quality (Decisional Conflict Scores, knowledge, realistic expectations and autonomy) and glycaemic control (glycosolated haemoglobin, HbA1c). SECONDARY OUTCOMES: Knowledge and realistic expectations of the risks and benefits of insulin therapy and diabetic complications. RESULTS: Intervention group: lower total Decisional Conflict Scores (17.4 vs 25.2, p<0.001); better knowledge (51.6% vs 28.8%, p<0.001); realistic expectations (risk of 'hypo', 'weight gain', 'complications'; 81.0% vs 5.2%, 70.5% vs 5.3%, 26.3% vs 5.0% respectively, p<0.001); and were more autonomous in decision-making (64.1% vs 42.9%, p=0.012). No significant difference in the glycaemic control between the two groups. CONCLUSIONS: Use of the PANDAs decision aid reduces decisional conflict, improves knowledge, promotes realistic expectations and autonomy in people with diabetes making treatment choices in general practice. ISRCTN TRIALS REGISTER NUMBER: 14842077.

Developing a method to identify medicines non-adherence in a community sample of adults with epilepsy.

The aim is to propose a simple way of identifying patients at risk of antiepileptic drug (AED) non-adherence during epilepsy review (a scheduled consultation to review the patient and their condition). The use of a multi-modal approach to the problem of non-adherence is necessary because of the limitations of existing methods. A mixed methodology was developed in a nested study using a case record review to calculate the medicine possession ratio (MPR) from the AED medication records of a community sample, a literature review and a consensus panel to develop a questionnaire to address how people manage their epilepsy, particularly medicine management, and how to collect information about non-adherence through stated findings in keeping with non-adherent behavior. Results show that a medicine record can be used to estimate the MPR (<80% indicates non-adherence) and that an open and non-confrontational consultation style can be fostered by using key questions within the consultation to identify those at risk of non-adherence.

Referring patients to specialists: a structured vignette survey of Australian and British GPs.

BACKGROUND: In Australia and in the United Kingdom (UK) access to specialists is sanctioned by General Practitioners (GPs). It is important to understand how practitioners determine which patients warrant referral. METHODS: A self-administered structured vignette postal survey of General Practitioners in Western Australia and the United Kingdom. Sixty-four vignettes describing patients with colorectal symptoms were constructed encompassing six clinical details. Nine vignettes, chosen at random, were presented to each individual. Respondents were asked if they would refer the patient to a specialist and how urgently. Logistic regression and parametric tests were used to analyse the data RESULTS: We received 260 completed questionnaires. 58% of 'cancer vignettes' were selected for 'urgent' referral. 1632/2367 or 69% of all vignettes were selected for referral. After adjusting for clustering the model suggests that 38.4% of the variability is explained by all the clinical variables as well as the age and experience of the respondents. 1012 or 42.8 % of vignettes were referred 'urgently'. After adjusting for clustering the data suggests that 31.3 % of the variability is explained by the model. The age of the respondents, the location of the practice and all the clinical variables were significant in the decision to refer urgently. CONCLUSION: GPs' referral decisions for patients with lower bowel symptoms are similar in the two countries. We question the wisdom of streaming referrals from primary care without a strong evidence base and an effective intervention for implementing guidelines. We conclude that implementation must take into account the profile of patients but also the characteristics of GPs and referral policies.

Effectiveness of paramedic practitioners in attending 999 calls from elderly people in the community: cluster randomised controlled trial.

OBJECTIVE: To evaluate the benefits of paramedic practitioners assessing and, when possible, treating older people in the community after minor injury or illness. Paramedic practitioners have been trained with extended skills to assess, treat, and discharge older patients with minor acute conditions in the community. DESIGN: Cluster randomised controlled trial involving 56 clusters. Weeks were randomised to the paramedic practitioner service being active (intervention) or inactive (control) when the standard 999 service was available. SETTING: A large urban area in England. PARTICIPANTS: 3018 patients aged over 60 who called the emergency services (n=1549 intervention, n=1469 control). MAIN OUTCOME MEASURES: Emergency department attendance or hospital admission between 0 and 28 days; interval from time of call to time of discharge; patients' satisfaction with the service received. RESULTS: Overall, patients in the intervention group were less likely to attend an emergency department (relative risk 0.72, 95% confidence interval 0.68 to 0.75) or require hospital admission within 28 days (0.87, 0.81 to 0.94) and experienced a shorter total episode time (235 v 278 minutes, 95% confidence interval for difference -60 minutes to -25 minutes). Patients in the intervention group were more likely to report being highly satisfied with their healthcare episode (relative risk 1.16, 1.09 to 1.23). There was no significant difference in 28 day mortality (0.87, 0.63 to 1.21). CONCLUSIONS: Paramedics with extended skills can provide a clinically effective alternative to standard ambulance transfer and treatment in an emergency department for elderly patients with acute minor conditions. TRIAL REGISTRATION: ISRCTN27796329 [controlled-trials.com].

Outcome at 6 months after admission for pediatric intensive care: a report of a national study of pediatric intensive care units in the United kingdom.

OBJECTIVE: The goal was to measure, by using the Health Utilities Index, the health status of children 6 months after admission to PICUs in the United Kingdom. METHODS: All PICUs in the United Kingdom were invited to participate. Children who were > or = 6 months of age at admission and were discharged alive from participating units during a 1-year period were eligible for this study. Children with completed consent forms who had survived to 6 months after admission received the Health Utilities Index questionnaire. RESULTS: Admission data on 7214 admissions to 22 units were collected between March 2001 and February 2002. Of those patients, 6786 survived to unit discharge, and consent for follow-up contact was obtained for 2642. At 6 months after admission, the mortality rate was estimated at 11.1% and 2034 children were still alive and contactable. Of those children, Health Utilities Index questionnaires were returned by 1455. No impairment was indicated for 767, 951, 940, 919, 962, and 939 children with respect to the Health Utilities Index sensation, cognition, emotion, pain, mobility, and self-care attributes, respectively. The mean +/- SE Health Utilities Index utility score was 0.73 +/- 0.01, with 397 children (27.3%) in full health. CONCLUSIONS: Death after pediatric intensive care in the United Kingdom is uncommon, making assessment of health status important. At 6 months after admission, there is significant morbidity. To assess the impact of strategies to improve or to optimize care on longer-term outcomes, standardized collection of data on preexisting comorbidities and illness severity is required.