North Wales Centre for Primary Care Research Research Overview

Transcription

1 CANOLFAN GOGLEDD CYMRU AR GYFER YMCHWIL GOFAL CYCHWYNNOL NORTH WALES CENTRE FOR PRIMARY CARE RESEARCH North Wales Centre for Primary Care Research Research Overview Prof Richard Neal

2 Who are we? The North Wales Centre for Primary Care Research (NWCPCR) is a research and teaching group that form part of the School of Healthcare Sciences, Bangor University. We aim to conduct high-quality primary care research that impacts upon clinical practice and health policy Staff 20 research / attached / admin staff Senior clinical & non-clinical academics Research fellows & associates Trainee doctors (GPs / FY1s) PhD students Dedicated research administrative support

3 What do we do? Cancer in primary care: Diagnose quickly, follow-up safely Impact of symptomatic diagnosis on outcomes Expediting diagnosis through primary care Redesigning prostate cancer care End of life care Musculoskeletal and rehabilitation research Multidisciplinary rehabilitation after fracture femur in elderly Treatments for back pain & sciatica

4 Funding NWCPCR have been either Lead Applicant or Co-Investigator on > 13.5M of peer reviewed, open competition research funding over the last 5 years Highlights Williams N et al. A randomised controlled trial of adalimumab injection compared with placebo injection for patients receiving physiotherapy treatment for sciatica. Sub-Cutaneous Injection of Adalimumab Trial compared with Control (SCIATiC). HTA, 1.2M, Little P et al (incl Wilkinson C & Neal RD). Cancer: Life Affirming Survivorship Support in PrimaryCcare (CLASP) Programme. NIHR, 2.5M, Edwards A, Neal RD, Snooks H, Kenkre J, et al. PRIME Centre Wales. Health & Care Research Wales, 3.6M,

5 Publications & REF Peer Reviewed Publications NWCPCR staff have published over 90 peer reviewed publications within the last 5 years. Research Excellence Framework (REF) 2014 Results We were in the top unit of assessment in Bangor University Our submission to unit of assessment 3 (allied health professions, nursing, midwifery, pharmacy, dentistry) has resulted in us being ranked overall 20th out of 94 institutions in the UK. 95% of the outputs submitted were rated at 3/4 star- world leading and internationally excellent. On our outputs alone we are ranked 3rd out of 94 institutions

6 ELCID Early lung cancer investigation and diagnosis (CR-UK) This trial aimed to assess the feasibility, and inform the design of, a large, UK-wide, clinical trial of a change to the NICE guidelines for urgent referral for chest X-ray for suspected lung cancer It utilizes a combination of workshop, health economic, quality of life, qualitative, and quantitative methods, in order to fully assess feasibility Demonstrated that it was feasible and acceptable to recruit practices and patients to an individually RCT in primary care for earlier chest X-ray for high risk patients

7 Qualitative Interview Sub Study Non Consenters to Trial but agreed to interview n=9 Lost to follow-up n=7 Actual interview n=2 Assessed for eligibility n = 643 Rando mised (n=262) Excluded (n=7), randomised in error Qualitative Interview Sub Study Agreed to be interviewed n=10 Actual interview n=10 Allocated to NICE n=128 Withdrawal n=0 Allocated to extra-nice n=127 Received chest x-ray within 8 weeks n=120 Received chest x-ray after more than 8 weeks n=3 Site confirms patient did not receive chest x ray n=4 No confirmation of chest x-ray date received n=0 Withdrawal n=0 Qualitative Interview Sub Study Agreed to be interviewed n=10 outlier n=1 actual interview n=9 Baseline CRF (post randomisation) Completed all questionnaires n=118, 118/128 = 92.2% Lost to follow-up n=0 Withdrawal n=0 Completed all questionnaires n=110, 110/127 = 86.6% Lost to follow-up n=0 Withdrawal n=0 2 month CRF Completed all questionnaires n=82, 82/127 = 65.1% Lost to follow-up (n=1) (1 patient died prior to 2 months) Withdrawal n=0 Completed all questionnaires n=84, 84/127 = 72.3% Lost to follow-up (n=0) Withdrawal n=0 12 month CRF Completed CRFs n=122, expected=126, 122/126= 96.8%. Withdrawal (n=2) between 2 and 12 months, complete study withdrawal. 1 withdrawn has CRF returned Died between 2 and 12 months, CRF returned (n=1). Missing CRF (n=4) Excluded from analysis (n=0) Completed CRFs n=120, expected=125, 120/125= 96.0% Withdrawal- n=2 between 2 and 12 months, complete study withdrawal Died between 2 and 12 months, CRF returned (n=1). Missing CRF (n=5) Excluded from analysis (n=0)

8 International Cancer Benchmarking Partnership (ICBP): Module 4 4 tumour sites: Breast Colorectal Lung Ovarian 200 patients per cancer Aim To describe and compare between countries: Patient routes to diagnosis Time intervals from first symptom until start of treatment Time intervals where actions to reduce delays could be focused

9 ICBP Module 4 Why is this study important? UK countries have poorer cancer outcomes than much of Western Europe Need to go beyond quantifying cancer survival differences by exploring possible reasons for differences Methods: Patients initially identified by WCISU, GP informed of eligibility Patient GP Consultant Questionnaire Routes to diagnosis Patient interval Diagnostic interval Treatment interval

10 ICBP Module 4 Data collection complete - patient questionnaires received and response rates (%) Jurisdiction Breast Colorectal Lung Ovarian England 416 (32.7 %) 296 (24.4 %) 273 (15.5 %) 271 (25.9 %) Wales 281 (34.2 %) 307 (24.6 %) 224 (12.6 %) 98 (22.3 %) Scotland 414 (36.3 %) 337 (31.5 %) 236 (20.8 %) - N. Ireland 355 (48.0 %) 277 (47.6 %) - - GP questionnaire response rate in Wales: % Consultant questionnaire response rate in Wales: % Preliminary quantitative analysis for breast cancer ongoing Qualitative analysis of free-text comments Impact publication, policy, ongoing partnership

11 Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) [NIHR HTA Programme funded] Aims 1) To develop a multidisciplinary rehabilitation programme 2) To assess the acceptability of the rehabilitation programme amongst patients, carers and clinicians, and to assess its feasibility for use in a future RCT 3) To explore the methodological issues for an economic evaluation alongside the future RCT

12 Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) Why this study is important Proximal hip fracture is a common, major problem in old health Many die (25%) or lose their independence Large cost burden on society ( 2 Billion) Multidisciplinary Rehabilitation may aid recovery, but more research needed Methods Phase I Developing the Intervention Realist review Survey of rehabilitation managers and therapists Focus groups of participants and rehabilitation professionals Phase II Assessing feasibility for a future RCT Anonymised cohort study Randomised feasibility study

13 FEMuR flow diagram Withdrawals 1 Participants Assessed 593 Participants Identified as Eligible 266 Participants Approached by Researcher 193 Participants Consented to Participate 62 Participants Completed Baseline and Randomised 61 Ineliglible 327 Capacity 161 Independence 61 Age 41 Outside BCUHB 30 No Surgery 23 No Fracture 2 Unknown 9 Discharged 30 Not approached 22 Deceased 11 Unknown 10 Not Recruited 131 Burden 60 Dislike Study 10 Dislike Questionnaire 3 Not Disclosed 3 Other Reasons 19 Group 1 - Baseline Group 2 - Baseline Withdrawals 8 Lost to Follow Up 4 Group 1 4 Group 1 0 Group 2 4 Group 2 4 Group 1 - Follow Up Group 2 - Follow Up 25 24

14 SCIATiC SubCutaneous Injection of Adalimumab Trial Compared with Control Randomised controlled trial of adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica [NIHR HTA Programme funded] Aims To evaluate the effectiveness and costeffectiveness of subcutaneous injections of adalimumab plus physiotherapy compared with placebo injection of saline plus physiotherapy for patients with sciatica who have failed first line primary care treatment

15 SCIATiC SubCutaneous Injection of Adalimumab Trial Compared with Control Why this study is important Sciatica is common, costly and disabling Biological treatments such as adalimumab are antibodies targeting Tumour Necrosis Factor alpha, released from ruptured intervertebral discs, which may be useful in sciatica. Recent systematic reviews have concluded that they may be effective, but that a definitive randomised controlled trial is needed. Methods Pragmatic, parallel group, Randomised Controlled Trial Blinded participants, clinicians, outcome assessment and statistical analysis Concurrent economic evaluation Internal pilot

16 SCIATiC SubCutaneous Injection of Adalimumab Trial Compared with Control

17 TOPCAT-P Trial of Personalised Care After Treatment Prostate cancer (Macmillan) Aim Assess the feasibility and acceptability of nurse-led key care worker intervention to improve self-management and address the high level of unmet need of prostate cancer survivors. Objectives The patient recruitment and attrition rates The completion rate of outcome measures The standard deviation of the intervention outcome measures The time needed to collect and analyse data The patient feedback to the intervention

18 Cases screened (n=1469) Identified/invited (n=305) Recruited (n=95) Not eligible (n=1164) Declined invitation (n=5) Did not respond (n=205) Assessed at Baseline (n=95) Randomised (n=95) Control group (n=47) Received allocated intervention (n=46) Withdrawals (n=1) (hormone treatment restart) Analysed (n=42) Lost to follow-up (n=4) (did not respond) Intervention group (n=48) Received allocated intervention (n=45) Withdrawals (n=3) (carer burden, family loss pre-intervention) Analysed (n=41) Lost to follow-up (n=1) (did not respond) Feedback interview (n=32)

19 TOPCAT-P Conclusions Feasibility (vs. target) Recruitment rate: 31% (>30-50%) Attrition rate: 4% (<17-35%) Outcome measures completion rate: 91% (>65-83%) Recruitment of men sooner after treatment (?) Acceptability Positive response during the intervention No adverse events related to the intervention Positive collaboration with hospital and primary care GPs followed-up referrals Patients confident to approach GP

20 Talking HPV Talking about Human Papillomavirus related cancer (H&CRW funded) Aim To develop and test evidence-based scripts to help clinicians share information about HPV-related cancers, along with user-friendly, takehome information for patients and their partners Information should be accurate, true, succinct, salient, patient-centred, reassuring, and in plain language

21 Talking HPV Why this study is important Public awareness of HPV is growing; patients are asking questions Information about HPV is difficult to convey Rapid increase in HPV-related cancers Need to find the best way for clinicians to talk about HPV with cancer patients Methods Previous study & literature review to develop draft list of messages Clinician interviews and advisory group input to augment and refine messages Patient interviews to: Prioritise Phrase and frame Test (comprehension, acceptability, utility)

22 Talking HPV Clinician Interviews 36 telephone interviews completed

23 Talking HPV Clinician Interview Results what they said Patients do their research; they ask questions It can be difficult to talk to patients when partners are present (especially oral & anal) Some patients get very upset They are concerned that patients may blame themselves (or their partners) They aren t equipped to answer their questions More open discussion to normalise this

24 Palliative and supportive care studies CARiAD - CARer-ADministration of as-needed sub-cutaneous medication for breakthrough symptoms in homebased dying patients Question: Is carer-administration of as-needed subcutaneous medication for breakthrough symptoms in home based dying patients feasible and acceptable in the UK? Design: Randomised feasibility trial of carer-administered medication, versus usual care, with nested qualitative component NoBLE - Noisy Breathing at Life s End (NoBLE) Question: Should antimuscarinics be standard treatment for noisy breathing at the end of life (rattle)? Design: Randomised 2-arm double-blind placebo-controlled noninferiority trial (with internal pilot) of Hyoscine hydrobromide (HyoH) treatment course, with nested qualitative study, followed by a stakeholder workshop