BackgroundMultidisciplinary team (MDT) meetings have been endorsed by the Department of Health as... more BackgroundMultidisciplinary team (MDT) meetings have been endorsed by the Department of Health as the core model for managing chronic diseases. However, the evidence for their effectiveness is mixed and the degree to which they have been absorbed into clinical practice varies widely across conditions and settings. We aimed to identify the key characteristics of chronic disease MDT meetings that are associated with decision implementation, a measure of effectiveness, and to derive a set of feasible modifications to MDT meetings to improve decision-making.MethodsWe undertook a mixed-methods prospective observational study of 12 MDTs in the London and North Thames area, covering cancer, heart failure, mental health and memory clinic teams. Data were collected by observation of 370 MDT meetings, completion of the Team Climate Inventory (TCI) by 161 MDT members, interviews with 53 MDT members and 20 patients, and review of 2654 patients’ medical records. We examined the influence of pati...
Aim New and modified surgical procedures and devices are often introduced into clinical practice ... more Aim New and modified surgical procedures and devices are often introduced into clinical practice without adequate evidence of their safety and efficacy. To promote systematic evaluation of surgical innovations, the IDEAL and IDEAL-D frameworks outline recommendations for study design and governance for procedures and devices according to their stage of innovation. However, determining stage of innovation can be difficult, hindering use of such frameworks. There is a need for a detailed understanding of what stage of innovation means, and how it can be determined. The aim of this study is to understand the concept of stage of innovation as reported in the literature. Method A systematic review is being conducted. Searches of Ovid Medline and Embase databases have been performed. Articles were screened by title and, then by full text. s and foreign language articles were excluded. Data will be extracted verbatim regarding approaches to evaluating surgical innovations and determining s...
Aim Little is known about the electronic collection and clinical feedback of patient reported out... more Aim Little is known about the electronic collection and clinical feedback of patient reported outcomes (ePROs) post-surgical discharge. This review summarised the evidence on the collection and uses of electronic systems to collect PROs after discharge from hospital following surgery. Method Systematic searches of Medline, Embase, PsycINFO, CINAHL and Cochrane Central were undertaken from database inception to July 2019 using terms for “patient reported outcomes”, “electronic”, “surgery” and “at home”. Primary research of all study designs was included if they used electronic systems to collect PRO data away from formal health care settings. Only studies in adult patients admitted for surgery then discharged from hospital were eligible. Results From 9,474 records identified, 15 studies were reviewed including three randomised controlled trials. Seven studies were in orthopaedic surgery. Most studies used commercial ePRO systems (n = 9/12). Six studies reported types of electronic de...
Background Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunom... more Background Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatory actions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19. Methods In this randomised, controlled, open-label, adaptive platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), several possible treatments were compared with usual care in patients admitted to hospital with COVID-19 in the UK. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients were randomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once per day by mouth or intravenously for 10 days or until discharge (or allocation to one of the other RECOVERY treatment groups). Patients were assigned via web-based simple (unstratified) randomisation with allocation concealment and were twice as likely to be randomly assigned to usual care than to any of the active treatment groups. Participants and local study staff were not masked to the allocated treatment, but all others involved in the trial were masked to the outcome data during the trial. The primary outcome was 28-day all-cause mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936. Findings Between April 7 and Nov 27, 2020, of 16 442 patients enrolled in the RECOVERY trial, 9433 (57%) were eligible and 7763 were included in the assessment of azithromycin. The mean age of these study participants was 65•3 years (SD 15•7) and approximately a third were women (2944 [38%] of 7763). 2582 patients were randomly allocated to receive azithromycin and 5181 patients were randomly allocated to usual care alone. Overall, 561 (22%) patients allocated to azithromycin and 1162 (22%) patients allocated to usual care died within 28 days (rate ratio 0•97, 95% CI 0•87-1•07; p=0•50). No significant difference was seen in duration of hospital stay (median 10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days (rate ratio 1•04, 95% CI 0•98-1•10; p=0•19). Among those not on invasive mechanical ventilation at baseline, no significant difference was seen in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (risk ratio 0•95, 95% CI 0•87-1•03; p=0•24). Interpretation In patients admitted to hospital with COVID-19, azithromycin did not improve survival or other prespecified clinical outcomes. Azithromycin use in patients admitted to hospital with COVID-19 should be restricted to patients in whom there is a clear antimicrobial indication.
Understanding risks, mitigation and innovation for surgery in a COVID-19 world Editor COVID-19 pr... more Understanding risks, mitigation and innovation for surgery in a COVID-19 world Editor COVID-19 presents an unquantified risk for operating theatre teams, and surgeons have some of the highest mortality rates for healthcare staff exposed to the virus. It is unclear how teams should function, how risk is distributed by specialty, procedure and technology, and how risk is mitigated. What is clear, however, is that in these situations, surgeons and teams are often creative and innovative. It is well recognized that innovation can occur during adversity 1. Sharing good ideas and lessons learnt from novel solutions to overcome risk will disseminate good practice. Currently, guidelines are emerging that are valuable 2. We propose that qualitative interviews about these complex situations will provide important and rich insights into surgical teams' experiences of current practices 3. This will complement and add to the evolving guidance. We are undertaking a focused and dynamic qualitative project to understand current experiences in the National Health Service (NHS) as they evolve, and the international response by surgical teams, with the aim of improving outcomes for staff and patients. We will conduct 'virtual interviews' with a multidisciplinary cohort of surgeons, theatre nurses, operating department practitioners and anaesthetists. This will take the form of semi-structured interviews to explore experiences, perceptions of risk and responses/ innovations to reduce risk. These valuable discussions will generate themes around the main challenges, concerns and potential solutions. The international theatre team response will be particularly important in identifying how 'best practice' has evolved outside the UK, particularly in those nations 'ahead of the curve'. We will also generate hypotheses to be tested by high impact, targeted follow-on interventional research.
IntroductionBurn care represents a healthcare and economic burden to patients internationally. Ch... more IntroductionBurn care represents a healthcare and economic burden to patients internationally. Choice of the most clinically effective treatment strategies requires evidence which is best obtained through high-quality randomised controlled trials (RCT). The number of published RCTs of burn care is increasing. However, trial quality and reporting standards are unclear. This study will assess the risk of bias and adequacy of reporting in recent burn care RCTs using tools endorsed by the Cochrane Collaboration.Methods and analysisA systematic literature review will be undertaken, assessing parallel group RCTs evaluating therapeutic interventions for patients with cutaneous burns. Literature searches will use Ovid Medline, Ovid Embase, Web of Science and the Cochrane Library. Separate searches for each database will include medical subject heading and free text terms including ‘burn’, ‘scald’, ‘thermal injury’ and ‘RCT’. Two reviewers will independently assess each study for inclusion. ...
indicators of lower self-esteem we found radiotherapy and the presence of complications during th... more indicators of lower self-esteem we found radiotherapy and the presence of complications during the reconstructive process; not so chemotherapy. Conclusions: Breast reconstruction favorably influences patients' selfesteem; however, it is also affected by other factors such as age, rafiotherapy surgical success, etc. Conflict of interest: No conflict of interest.
The RCSEng recommends the use patient reported outcome data in surgical trials, although there ar... more The RCSEng recommends the use patient reported outcome data in surgical trials, although there are no validated questionnaires to measure these outcomes within emergency surgery. The aim of this study, therefore, was to explore the views of patients admitted with unplanned abdominal problems. Methods: Semi-structured interviews were conducted with a purposive sample of patients admitted to SAU at 2 acute hospitals in the South West of England. Interviews explored patients' experiences regarding their illness, treatment and recovery. Analysis was an ongoing iterative process, occurring concurrently alongside data collection. Results: Fourteen semi-structured patient interviews were carried out (10 females, median age 51.5, range 27e77) covering the spectrum of nontrauma emergency surgery presentations. Six patients were treated conservatively, while 8 patients underwent either endoscopy or surgery. All patients reported abdominal pain as the primary reason for seeking medical attention. Immobilisation was the main consequence of pain regardless of age. Treatment related complications were more common in patients who underwent surgery, and were associated with a prolonged period of immobility during recovery. Conclusion: Patients admitted with unplanned abdominal problems report a similar collection of experiences. Future work should focus on the development of a core outcome set for this patient population.
A comprehensive evaluation of bariatric surgery is required to inform decision-making. This will ... more A comprehensive evaluation of bariatric surgery is required to inform decision-making. This will include measures of benefit and risk. It is possible that stakeholders involved with surgery value these outcomes differently, although this has not previously been explored. This study aimed to investigate and compare how professionals and patients prioritise outcomes of bariatric surgery. Systematic reviews and qualitative interviews created an exhaustive list of outcomes. This informed the development of a 130-item questionnaire, structured in four sections (complications of surgery; clinical effectiveness; signs, symptoms, and other measures; quality of life). Health professionals and patients rated the importance of each item on a 1-9 scale. Items rated 8-9 by at least 70 % of the participants were considered prioritised. Items prioritised in each section were compared between professionals and patients and interrater agreement assessed using kappa statistics (ĸ). One hundred sixty-...
Introduction In order to detect all cases of Barrett's oesophagus (BE) in the population, wit... more Introduction In order to detect all cases of Barrett's oesophagus (BE) in the population, with the aim of reducing adenocarcinoma associated mortality, screening needs to be considered. Unsedated transnasal endoscopy (TNE) can potentially offer a safer and less expensive alternative to conventional sedated endoscopy (CE) for detecting BE. Aims (1) To evaluate the sensitivity and specificity of TNE in diagnosing BE compared with CE. (2) To assess patient acceptability of TNE for a future multicentre screening trial. Methods Patients with known BE under surveillance and those referred for routine endoscopy for other reasons underwent both TNE and CE in a randomised cross-over design. TNE findings of endoscopic BE, biopsy size and presence of intestinal metaplasia (IM) were compared against CE, which was used as gold standard. Pre and post endoscopy short-form spielberger state-trait questionnaires (SF6), a visual analogue scale and a single question addressing preference for endoscopy type were used to measure patient acceptability of the procedures. Results Of 57 patients randomised, 50 completed the study. All 22 BE cases with columnar lined epithelium (CLE) on CE were correctly diagnosed by TNE. Although the biopsy size of TNE was significantly smaller compared to CE (mean size 2.59 vs 4.74 p<0.0001), it detected an equal number of IM cases and there was one case of low grade dysplasia which interestingly was not picked up by CE. Abstract 019 shows sensitivity, specificity and diagnostic accuracy (including Pearson-Clopper CI) for diagnosing BE and IM using TNE compared with CE as the gold standard. The mean difference between the two procedures in determining the length of BE was 0.02. The 95% Bland and Altman limits of agreement was between −2.08 and 2.13 with 49 cases (98%) falling within the pre-determined level of agreement of ±1.5 cm. The mean pre and post procedure anxiety score for TNE (13.3 vs 14.0) and CE (13.2 vs 13.5) were not significantly different (p=0.15). The post endoscopy experience of TNE was comparable to CE (mean 5.0 vs 4.9, p=0.77). Abstract PTU-019 Sensitivity Specificity Diagnostic Accuracy BE 100 (85–100) 100 (88–100) 100 (93–100) IM 100 (81–100) 100 (89–100) 100 (93–100) Conclusion TNE is accurate in diagnosing BE and detecting IM. Despite the smaller biopsy size, it detected an equal number of IM cases and showed potential to detect dysplasia. It was well tolerated and preferred by patients and may be an efficient screening method for BE.
Background: Qualitative evidence suggests patient-reported outcome (PRO) information is frequentl... more Background: Qualitative evidence suggests patient-reported outcome (PRO) information is frequently absent from clinical trial protocols, potentially leading to inconsistent PRO data collection and risking bias. Direct evidence regarding PRO trial protocol content is lacking. The aim of this study was to systematically evaluate the PRO-specific content of UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme trial protocols. Methods and Findings: We conducted an electronic search of the NIHR HTA programme database (inception to August 2013) for protocols describing a randomised controlled trial including a primary/secondary PRO. Two investigators independently reviewed the content of each protocol, using a specially constructed PRO-specific protocol checklist, alongside the 'Standard Protocol Items: Recommendations for Interventional Trials' (SPIRIT) checklist. Disagreements were resolved through discussion with a third investigator. 75 trial protocols were included in the analysis. Protocols included a mean of 32/51 (63%) SPIRIT recommendations (range 16-41, SD 5.62) and 11/33 (33%) PRO-specific items (range 4-18, SD 3.56). Over half (61%) of the PRO items were incomplete. Protocols containing a primary PRO included slightly more PRO checklist items (mean 14/33 (43%)). PRO protocol content was not associated with general protocol completeness; thus, protocols judged as relatively 'complete' using SPIRIT were still likely to have omitted a large proportion of PRO checklist items. Conclusions: The PRO components of HTA clinical trial protocols require improvement. Information on the PRO rationale/ hypothesis, data collection methods, training and management was often absent. This low compliance is unsurprising; evidence shows existing PRO guidance for protocol developers remains difficult to access and lacks consistency. Study findings suggest there are a number of PRO protocol checklist items that are not fully addressed by the current SPIRIT statement. We therefore advocate the development of consensus-based supplementary guidelines, aimed at improving the completeness and quality of PRO content in clinical trial protocols.
Background: Recruitment to pragmatic randomised controlled trials (RCTs) is acknowledged to be di... more Background: Recruitment to pragmatic randomised controlled trials (RCTs) is acknowledged to be difficult, and few interventions have proved to be effective. Previous qualitative research has consistently revealed that recruiters provide imbalanced information about RCT treatments. However, qualitative research can be time-consuming to apply. Within a programme of research to optimise recruitment and informed consent in challenging RCTs, we developed a simple technique, Q-QAT (Quanti-Qualitative Appointment Timing), to systematically investigate and quantify the imbalance to help identify and address recruitment difficulties. Methods: The Q-QAT technique comprised: 1) quantification of time spent discussing the RCT and its treatments using transcripts of audio-recorded recruitment appointments, 2) targeted qualitative research to understand the obstacles to recruitment and 3) feedback to recruiters on opportunities for improvement. This was applied to two RCTs with different clinical contexts and recruitment processes. Comparisons were made across clinical centres, recruiters and specialties. Results: In both RCTs, the Q-QAT technique first identified considerable variations in the time spent by recruiters discussing the RCT and its treatments. The patterns emerging from this initial quantification of recruitment appointments then enabled targeted qualitative research to understand the issues and make suggestions to improve recruitment. In RCT1, presentation of the treatments was balanced, but little time was devoted to describing the RCT. Qualitative research revealed patients would have considered participation, but lacked awareness of the RCT. In RCT2, the balance of treatment presentation varied by specialists and centres. Qualitative research revealed difficulties with equipoise and confidence among recruiters presenting the RCT. The quantitative and qualitative findings were well-received by recruiters and opportunities to improve information provision were discussed. A blind coding exercise across three researchers led to the development of guidelines that can be used to apply the Q-QAT technique to other difficult RCTs. Conclusion: The Q-QAT technique was easy to apply and rapidly identified obstacles to recruitment that could be understood through targeted qualitative research and addressed through feedback. The technique's combination of quantitative and qualitative findings enabled the presentation of a holistic picture of recruitment challenges and added credibility to the feedback process. Note: both RCTs in this manuscript asked to be anonymised, so no trial registration details are provided.
BackgroundMultidisciplinary team (MDT) meetings have been endorsed by the Department of Health as... more BackgroundMultidisciplinary team (MDT) meetings have been endorsed by the Department of Health as the core model for managing chronic diseases. However, the evidence for their effectiveness is mixed and the degree to which they have been absorbed into clinical practice varies widely across conditions and settings. We aimed to identify the key characteristics of chronic disease MDT meetings that are associated with decision implementation, a measure of effectiveness, and to derive a set of feasible modifications to MDT meetings to improve decision-making.MethodsWe undertook a mixed-methods prospective observational study of 12 MDTs in the London and North Thames area, covering cancer, heart failure, mental health and memory clinic teams. Data were collected by observation of 370 MDT meetings, completion of the Team Climate Inventory (TCI) by 161 MDT members, interviews with 53 MDT members and 20 patients, and review of 2654 patients’ medical records. We examined the influence of pati...
Aim New and modified surgical procedures and devices are often introduced into clinical practice ... more Aim New and modified surgical procedures and devices are often introduced into clinical practice without adequate evidence of their safety and efficacy. To promote systematic evaluation of surgical innovations, the IDEAL and IDEAL-D frameworks outline recommendations for study design and governance for procedures and devices according to their stage of innovation. However, determining stage of innovation can be difficult, hindering use of such frameworks. There is a need for a detailed understanding of what stage of innovation means, and how it can be determined. The aim of this study is to understand the concept of stage of innovation as reported in the literature. Method A systematic review is being conducted. Searches of Ovid Medline and Embase databases have been performed. Articles were screened by title and, then by full text. s and foreign language articles were excluded. Data will be extracted verbatim regarding approaches to evaluating surgical innovations and determining s...
Aim Little is known about the electronic collection and clinical feedback of patient reported out... more Aim Little is known about the electronic collection and clinical feedback of patient reported outcomes (ePROs) post-surgical discharge. This review summarised the evidence on the collection and uses of electronic systems to collect PROs after discharge from hospital following surgery. Method Systematic searches of Medline, Embase, PsycINFO, CINAHL and Cochrane Central were undertaken from database inception to July 2019 using terms for “patient reported outcomes”, “electronic”, “surgery” and “at home”. Primary research of all study designs was included if they used electronic systems to collect PRO data away from formal health care settings. Only studies in adult patients admitted for surgery then discharged from hospital were eligible. Results From 9,474 records identified, 15 studies were reviewed including three randomised controlled trials. Seven studies were in orthopaedic surgery. Most studies used commercial ePRO systems (n = 9/12). Six studies reported types of electronic de...
Background Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunom... more Background Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatory actions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19. Methods In this randomised, controlled, open-label, adaptive platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), several possible treatments were compared with usual care in patients admitted to hospital with COVID-19 in the UK. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients were randomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once per day by mouth or intravenously for 10 days or until discharge (or allocation to one of the other RECOVERY treatment groups). Patients were assigned via web-based simple (unstratified) randomisation with allocation concealment and were twice as likely to be randomly assigned to usual care than to any of the active treatment groups. Participants and local study staff were not masked to the allocated treatment, but all others involved in the trial were masked to the outcome data during the trial. The primary outcome was 28-day all-cause mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936. Findings Between April 7 and Nov 27, 2020, of 16 442 patients enrolled in the RECOVERY trial, 9433 (57%) were eligible and 7763 were included in the assessment of azithromycin. The mean age of these study participants was 65•3 years (SD 15•7) and approximately a third were women (2944 [38%] of 7763). 2582 patients were randomly allocated to receive azithromycin and 5181 patients were randomly allocated to usual care alone. Overall, 561 (22%) patients allocated to azithromycin and 1162 (22%) patients allocated to usual care died within 28 days (rate ratio 0•97, 95% CI 0•87-1•07; p=0•50). No significant difference was seen in duration of hospital stay (median 10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days (rate ratio 1•04, 95% CI 0•98-1•10; p=0•19). Among those not on invasive mechanical ventilation at baseline, no significant difference was seen in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (risk ratio 0•95, 95% CI 0•87-1•03; p=0•24). Interpretation In patients admitted to hospital with COVID-19, azithromycin did not improve survival or other prespecified clinical outcomes. Azithromycin use in patients admitted to hospital with COVID-19 should be restricted to patients in whom there is a clear antimicrobial indication.
Understanding risks, mitigation and innovation for surgery in a COVID-19 world Editor COVID-19 pr... more Understanding risks, mitigation and innovation for surgery in a COVID-19 world Editor COVID-19 presents an unquantified risk for operating theatre teams, and surgeons have some of the highest mortality rates for healthcare staff exposed to the virus. It is unclear how teams should function, how risk is distributed by specialty, procedure and technology, and how risk is mitigated. What is clear, however, is that in these situations, surgeons and teams are often creative and innovative. It is well recognized that innovation can occur during adversity 1. Sharing good ideas and lessons learnt from novel solutions to overcome risk will disseminate good practice. Currently, guidelines are emerging that are valuable 2. We propose that qualitative interviews about these complex situations will provide important and rich insights into surgical teams' experiences of current practices 3. This will complement and add to the evolving guidance. We are undertaking a focused and dynamic qualitative project to understand current experiences in the National Health Service (NHS) as they evolve, and the international response by surgical teams, with the aim of improving outcomes for staff and patients. We will conduct 'virtual interviews' with a multidisciplinary cohort of surgeons, theatre nurses, operating department practitioners and anaesthetists. This will take the form of semi-structured interviews to explore experiences, perceptions of risk and responses/ innovations to reduce risk. These valuable discussions will generate themes around the main challenges, concerns and potential solutions. The international theatre team response will be particularly important in identifying how 'best practice' has evolved outside the UK, particularly in those nations 'ahead of the curve'. We will also generate hypotheses to be tested by high impact, targeted follow-on interventional research.
IntroductionBurn care represents a healthcare and economic burden to patients internationally. Ch... more IntroductionBurn care represents a healthcare and economic burden to patients internationally. Choice of the most clinically effective treatment strategies requires evidence which is best obtained through high-quality randomised controlled trials (RCT). The number of published RCTs of burn care is increasing. However, trial quality and reporting standards are unclear. This study will assess the risk of bias and adequacy of reporting in recent burn care RCTs using tools endorsed by the Cochrane Collaboration.Methods and analysisA systematic literature review will be undertaken, assessing parallel group RCTs evaluating therapeutic interventions for patients with cutaneous burns. Literature searches will use Ovid Medline, Ovid Embase, Web of Science and the Cochrane Library. Separate searches for each database will include medical subject heading and free text terms including ‘burn’, ‘scald’, ‘thermal injury’ and ‘RCT’. Two reviewers will independently assess each study for inclusion. ...
indicators of lower self-esteem we found radiotherapy and the presence of complications during th... more indicators of lower self-esteem we found radiotherapy and the presence of complications during the reconstructive process; not so chemotherapy. Conclusions: Breast reconstruction favorably influences patients' selfesteem; however, it is also affected by other factors such as age, rafiotherapy surgical success, etc. Conflict of interest: No conflict of interest.
The RCSEng recommends the use patient reported outcome data in surgical trials, although there ar... more The RCSEng recommends the use patient reported outcome data in surgical trials, although there are no validated questionnaires to measure these outcomes within emergency surgery. The aim of this study, therefore, was to explore the views of patients admitted with unplanned abdominal problems. Methods: Semi-structured interviews were conducted with a purposive sample of patients admitted to SAU at 2 acute hospitals in the South West of England. Interviews explored patients' experiences regarding their illness, treatment and recovery. Analysis was an ongoing iterative process, occurring concurrently alongside data collection. Results: Fourteen semi-structured patient interviews were carried out (10 females, median age 51.5, range 27e77) covering the spectrum of nontrauma emergency surgery presentations. Six patients were treated conservatively, while 8 patients underwent either endoscopy or surgery. All patients reported abdominal pain as the primary reason for seeking medical attention. Immobilisation was the main consequence of pain regardless of age. Treatment related complications were more common in patients who underwent surgery, and were associated with a prolonged period of immobility during recovery. Conclusion: Patients admitted with unplanned abdominal problems report a similar collection of experiences. Future work should focus on the development of a core outcome set for this patient population.
A comprehensive evaluation of bariatric surgery is required to inform decision-making. This will ... more A comprehensive evaluation of bariatric surgery is required to inform decision-making. This will include measures of benefit and risk. It is possible that stakeholders involved with surgery value these outcomes differently, although this has not previously been explored. This study aimed to investigate and compare how professionals and patients prioritise outcomes of bariatric surgery. Systematic reviews and qualitative interviews created an exhaustive list of outcomes. This informed the development of a 130-item questionnaire, structured in four sections (complications of surgery; clinical effectiveness; signs, symptoms, and other measures; quality of life). Health professionals and patients rated the importance of each item on a 1-9 scale. Items rated 8-9 by at least 70 % of the participants were considered prioritised. Items prioritised in each section were compared between professionals and patients and interrater agreement assessed using kappa statistics (ĸ). One hundred sixty-...
Introduction In order to detect all cases of Barrett's oesophagus (BE) in the population, wit... more Introduction In order to detect all cases of Barrett's oesophagus (BE) in the population, with the aim of reducing adenocarcinoma associated mortality, screening needs to be considered. Unsedated transnasal endoscopy (TNE) can potentially offer a safer and less expensive alternative to conventional sedated endoscopy (CE) for detecting BE. Aims (1) To evaluate the sensitivity and specificity of TNE in diagnosing BE compared with CE. (2) To assess patient acceptability of TNE for a future multicentre screening trial. Methods Patients with known BE under surveillance and those referred for routine endoscopy for other reasons underwent both TNE and CE in a randomised cross-over design. TNE findings of endoscopic BE, biopsy size and presence of intestinal metaplasia (IM) were compared against CE, which was used as gold standard. Pre and post endoscopy short-form spielberger state-trait questionnaires (SF6), a visual analogue scale and a single question addressing preference for endoscopy type were used to measure patient acceptability of the procedures. Results Of 57 patients randomised, 50 completed the study. All 22 BE cases with columnar lined epithelium (CLE) on CE were correctly diagnosed by TNE. Although the biopsy size of TNE was significantly smaller compared to CE (mean size 2.59 vs 4.74 p<0.0001), it detected an equal number of IM cases and there was one case of low grade dysplasia which interestingly was not picked up by CE. Abstract 019 shows sensitivity, specificity and diagnostic accuracy (including Pearson-Clopper CI) for diagnosing BE and IM using TNE compared with CE as the gold standard. The mean difference between the two procedures in determining the length of BE was 0.02. The 95% Bland and Altman limits of agreement was between −2.08 and 2.13 with 49 cases (98%) falling within the pre-determined level of agreement of ±1.5 cm. The mean pre and post procedure anxiety score for TNE (13.3 vs 14.0) and CE (13.2 vs 13.5) were not significantly different (p=0.15). The post endoscopy experience of TNE was comparable to CE (mean 5.0 vs 4.9, p=0.77). Abstract PTU-019 Sensitivity Specificity Diagnostic Accuracy BE 100 (85–100) 100 (88–100) 100 (93–100) IM 100 (81–100) 100 (89–100) 100 (93–100) Conclusion TNE is accurate in diagnosing BE and detecting IM. Despite the smaller biopsy size, it detected an equal number of IM cases and showed potential to detect dysplasia. It was well tolerated and preferred by patients and may be an efficient screening method for BE.
Background: Qualitative evidence suggests patient-reported outcome (PRO) information is frequentl... more Background: Qualitative evidence suggests patient-reported outcome (PRO) information is frequently absent from clinical trial protocols, potentially leading to inconsistent PRO data collection and risking bias. Direct evidence regarding PRO trial protocol content is lacking. The aim of this study was to systematically evaluate the PRO-specific content of UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme trial protocols. Methods and Findings: We conducted an electronic search of the NIHR HTA programme database (inception to August 2013) for protocols describing a randomised controlled trial including a primary/secondary PRO. Two investigators independently reviewed the content of each protocol, using a specially constructed PRO-specific protocol checklist, alongside the 'Standard Protocol Items: Recommendations for Interventional Trials' (SPIRIT) checklist. Disagreements were resolved through discussion with a third investigator. 75 trial protocols were included in the analysis. Protocols included a mean of 32/51 (63%) SPIRIT recommendations (range 16-41, SD 5.62) and 11/33 (33%) PRO-specific items (range 4-18, SD 3.56). Over half (61%) of the PRO items were incomplete. Protocols containing a primary PRO included slightly more PRO checklist items (mean 14/33 (43%)). PRO protocol content was not associated with general protocol completeness; thus, protocols judged as relatively 'complete' using SPIRIT were still likely to have omitted a large proportion of PRO checklist items. Conclusions: The PRO components of HTA clinical trial protocols require improvement. Information on the PRO rationale/ hypothesis, data collection methods, training and management was often absent. This low compliance is unsurprising; evidence shows existing PRO guidance for protocol developers remains difficult to access and lacks consistency. Study findings suggest there are a number of PRO protocol checklist items that are not fully addressed by the current SPIRIT statement. We therefore advocate the development of consensus-based supplementary guidelines, aimed at improving the completeness and quality of PRO content in clinical trial protocols.
Background: Recruitment to pragmatic randomised controlled trials (RCTs) is acknowledged to be di... more Background: Recruitment to pragmatic randomised controlled trials (RCTs) is acknowledged to be difficult, and few interventions have proved to be effective. Previous qualitative research has consistently revealed that recruiters provide imbalanced information about RCT treatments. However, qualitative research can be time-consuming to apply. Within a programme of research to optimise recruitment and informed consent in challenging RCTs, we developed a simple technique, Q-QAT (Quanti-Qualitative Appointment Timing), to systematically investigate and quantify the imbalance to help identify and address recruitment difficulties. Methods: The Q-QAT technique comprised: 1) quantification of time spent discussing the RCT and its treatments using transcripts of audio-recorded recruitment appointments, 2) targeted qualitative research to understand the obstacles to recruitment and 3) feedback to recruiters on opportunities for improvement. This was applied to two RCTs with different clinical contexts and recruitment processes. Comparisons were made across clinical centres, recruiters and specialties. Results: In both RCTs, the Q-QAT technique first identified considerable variations in the time spent by recruiters discussing the RCT and its treatments. The patterns emerging from this initial quantification of recruitment appointments then enabled targeted qualitative research to understand the issues and make suggestions to improve recruitment. In RCT1, presentation of the treatments was balanced, but little time was devoted to describing the RCT. Qualitative research revealed patients would have considered participation, but lacked awareness of the RCT. In RCT2, the balance of treatment presentation varied by specialists and centres. Qualitative research revealed difficulties with equipoise and confidence among recruiters presenting the RCT. The quantitative and qualitative findings were well-received by recruiters and opportunities to improve information provision were discussed. A blind coding exercise across three researchers led to the development of guidelines that can be used to apply the Q-QAT technique to other difficult RCTs. Conclusion: The Q-QAT technique was easy to apply and rapidly identified obstacles to recruitment that could be understood through targeted qualitative research and addressed through feedback. The technique's combination of quantitative and qualitative findings enabled the presentation of a holistic picture of recruitment challenges and added credibility to the feedback process. Note: both RCTs in this manuscript asked to be anonymised, so no trial registration details are provided.
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