Kerry Avery - Academia.edu (original) (raw)

Papers by Kerry Avery

Programme Grants for Applied Research, 2022

Cancer is treated using multiple modalities (e.g. surgery, radiotherapy and systemic therapies) a... more Cancer is treated using multiple modalities (e.g. surgery, radiotherapy and systemic therapies) and is frequently associated with adverse events that affect treatment delivery and quality of life. Regular adverse event reporting could improve care and safety through timely detection and management. Information technology provides a feasible monitoring model, but applied research is needed. This research programme developed and evaluated an electronic system, called eRAPID, for cancer patients to remotely self-report adverse events. The objectives were to address the following research questions: is it feasible to collect adverse event data from patients’ homes and in clinics during cancer treatment? Can eRAPID be implemented in different hospitals and treatment settings? Will oncology health-care professionals review eRAPID reports for decision-making? When added to usual care, will the eRAPID intervention (i.e. self-reporting with tailored advice) lead to clinical benefits (e.g. be...

Appendix A. DevPICv1. Participatory and Informed Consent for trial recruitment. Appendix B. DevPI... more Appendix A. DevPICv1. Participatory and Informed Consent for trial recruitment. Appendix B. DevPICv2. Participatory and Informed Consent for trial recruitment. (PDF 533 kb)

Trials, 2018

Background: Core outcome set (COS) developers increasingly employ Delphi surveys to elicit stakeh... more Background: Core outcome set (COS) developers increasingly employ Delphi surveys to elicit stakeholders' opinions of which outcomes to measure and report in trials of a particular condition or intervention. Research outside of Delphi surveys and COS development demonstrates that question order can affect response rates and lead to 'context effects', where prior questions determine an item's meaning and influence responses. This study examined the impact of question order within a Delphi survey for a COS for oesophageal cancer surgery. Methods: A randomised controlled trial was nested within the Delphi survey. Patients and health professionals were randomised to receive a survey including clinical and patient-reported outcomes (PROs), where the PRO section appeared first or last. Participants rated (1-9) the importance of 68 items for inclusion in a COS (ratings 7-9 considered 'essential'). Analyses considered the impact of question order on: (1) survey response rates; (2) participants' responses; and (3) items retained at end of the survey. Results: In total, 116 patients and 71 professionals returned completed surveys. Question order did not affect response rates among patients, but fewer professionals responded when clinical items appeared first (difference = 31.3%, 95% confidence interval [CI] = 13.6-48.9%, P = 0.001). Question order led to different context effects within patients and professionals. While patients rated clinical items highly, irrespective of question order, more PROs were rated essential when appearing last rather than first (difference = 23.7%, 95% CI = 10.5-40.8%). Among professionals, the greatest impact was on clinical items; a higher percentage rated essential when appearing last (difference = 11.6%, 95% CI = 0.0-23.3%). An interaction between question order and the percentage of PRO/clinical items rated essential was observed for patients (P = 0.025) but not professionals (P = 0.357). Items retained for further consideration at the end of the survey were dependent on question order, with discordant items (retained by one question order group only) observed in patients (18/68 [26%]) and professionals (20/68 [29%]). Conclusions: In the development of a COS, participants' ratings of potential outcomes within a Delphi survey depend on the context (order) in which the outcomes are asked, consequently impacting on the final COS. Initial piloting is recommended with consideration of the randomisation of items in the survey to reduce potential bias. Trial registration: The randomised controlled trial reported within this paper was nested within the development of a core outcome set to investigate processes in core outcome set development. Outcomes were not health-related and trial registration was not therefore applicable.

British Journal of Surgery, 2018

Background Accurate assessment of surgical-site infection (SSI) is crucial for surveillance and r... more Background Accurate assessment of surgical-site infection (SSI) is crucial for surveillance and research. Self-reporting patient measures are needed because current SSI tools are limited for assessing patients after leaving hospital. The Bluebelle Wound Healing Questionnaire (WHQ) was developed for patient or observer completion; this study tested its acceptability, scale structure, reliability and validity in patients with closed primary wounds after abdominal surgery. Methods Patients completed the WHQ (self-assessment) within 30 days after leaving hospital and returned it by post. Healthcare professionals completed the WHQ (observer assessment) by telephone or face-to-face. Questionnaire response rates and patient acceptability were assessed. Factor analysis and Cronbach's α examined scale structure and internal consistency. Test–retest and self- versus observer reliability assessments were performed. Sensitivity and specificity for SSI discrimination against a face-to-face r...

Understanding outcome selection, measurement and reporting for innovative invasive procedures: use of multiple data sources to conceptualize outcome domains for an early-phase surgical intervention core outcome set

The development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (SPIRIT-ROUTINE)

Protocol extended files

Additional file 1: Table S1. of Impact of question order on prioritisation of outcomes in the development of a core outcome set: a randomised controlled trial

Nurses: percentage of items rated essential within the non-comparative and comparative context (a... more Nurses: percentage of items rated essential within the non-comparative and comparative context (a consistency effect). (DOCX 13Â kb)

Additional file 1: of Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI)

Contains details of ethical approvals for the RCTs and ProtecT trial registrations. (DOCX 45 kb)

BMJ Open, 2021

IntroductionThe development of innovative invasive procedures and devices are essential to improv... more IntroductionThe development of innovative invasive procedures and devices are essential to improving outcomes in healthcare. However, how these are introduced into practice has not been studied in detail. The Lotus study will follow a wide range of ‘case studies’ of new procedures and/or devices being introduced into NHS trusts to explore what information is communicated to patients, how procedures are modified over time and how outcomes are selected and reported.Methods and analysisThis qualitative study will use ethnographic approaches to investigate how new invasive procedures and/or devices are introduced. Consultations in which the innovation is discussed will be audio-recorded to understand information provision practice. To understand if and how procedures evolve, they will be video recorded and non-participant observations will be conducted. Post-operative interviews will be conducted with the innovating team and patients who are eligible for the intervention. Audio-recordin...

Associated Universities, through the Laboratory Graduate Participation Program, is greatly apprec... more Associated Universities, through the Laboratory Graduate Participation Program, is greatly appreciated. I also thank Dr. D. A. McClure for encouraging me to apply for the Laboratory Graduate Participation Program. The ORIC staff has been most hospitable and I would like to thank both the professional and technical staffs for their assistance and availability whenever needed. I also thank Miss Helen Dockery for her aid in using the Nuclear Data Group plotting program at ORNL and Mrs. Martha Dawson for her excellent typing of this manuscript. Finally, but certainly not least of all, I would like to thank my wife, Arlene, for her patience and support in every way, during the past two years.

Journal of clinical epidemiology, Jan 16, 2018

To evaluate the impact of the Quintet Recruitment Intervention (QRI) on recruitment in challengin... more To evaluate the impact of the Quintet Recruitment Intervention (QRI) on recruitment in challenging randomized controlled trials (RCTs) that have applied the intervention. The QRI aims to understand recruitment difficulties, and then implements 'QRI-actions' to address these as recruitment proceeds. A mixed-methods study, comprising: a) before-and-after comparisons of recruitment rates and numbers of patients approached, and b) qualitative case studies, including documentary analysis and interviews with RCT investigators. Five UK-based publicly-funded RCTs were included in the evaluation. All recruited to target. RCT2 and RCT5 both received up-front pre-recruitment training before the intervention was applied. RCT2 did not encounter recruitment issues and recruited above target from its outset. Recruitment difficulties, particularly communication issues, were identified and addressed through QRI-actions in RCTs 1, 3, 4 and 5. Randomization rates significantly improved post-QR...

Patient Reported Outcome Measures for Major Lower Limb Amputation Caused by Peripheral Artery Disease or Diabetes: A Systematic Review

Journal of Vascular Surgery, 2021

OBJECTIVE Most major lower limb amputations are related to peripheral artery disease (PAD) or dia... more OBJECTIVE Most major lower limb amputations are related to peripheral artery disease (PAD) or diabetes. Just 40% of patients who undergo major lower limb amputation will use a prosthesis yet measures of surgical success commonly focus on prosthesis use. Patient reported outcome measures (PROMs) are valuable to comprehensively evaluate health related quality of life (HRQL) after surgery. This systematic review aimed to identify and describe PROMs available to assess HRQL in patients after amputation for PAD or diabetes. METHODS A search was conducted based on the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) for systematic reviews of PROMs. Ovid MEDLINE, Ovid EMBASE, PsycINFO, CINAHL, and Cochrane CENTRAL were also searched from inception until August 2019. Included were articles describing the development, measurement properties, or evaluation of HRQL via a PROM in adult patients after amputation for PAD or diabetes. Studies of amputation exclusively for trauma or malignancy were excluded. Data were collected on study characteristics, PROM characteristics (generic/disease specific), and properties of amputation specific PROMs. RESULTS Of 3 317 abstracts screened, 111 full text articles were assessed for eligibility and 64 included. Fifty-six studies evaluated HRQL, with 23 (46%) of these using an amputation specific PROM to do so. Eleven different amputation specific PROMs were identified, 10 (91%) of which were developed only for prosthesis users. One measure was suitable for use in all patients after amputation. This "Amputee single item mobility measure" includes a single item evaluating mobility. Nine studies reported some psychometric testing of an amputation specific PROM. CONCLUSION A well tested, multidimensional PROM applicable to wheelchair and prosthetic users after amputation is lacking and urgently needed for studies in this field. Future work to develop an appropriate measure is required.

A review of the Cochrane COVID-19 Study Register reveals inconsistency in the choice and measurement of SARS-CoV-2 infection outcomes in prevention trials

F1000Research, 2021

Background: Multiple studies are evaluating how to prevent SARS-CoV-2 infection. Interventions ar... more Background: Multiple studies are evaluating how to prevent SARS-CoV-2 infection. Interventions are wide ranging and include vaccines, prophylactic drugs, public health safety measures, and behavioural interventions. Heterogeneity in the outcomes measured and reported is leading to research waste and inefficiency, slowing worldwide identification and implementation of effective methods to prevent infection. A core outcome set (COS) for studies of interventions to prevent SARS-CoV-2 infection has recently been developed, identifying infection as a critical outcome to measure. This paper examines how SARS-CoV-2 infection outcomes are measured in registered COVID-19 prevention trials and considers how this can be improved. Methods: We searched the Cochrane COVID-19 Study Register to identify and review SARS-CoV-2 infection outcomes in prevention trials, including the rationale for choice of outcome measurement. We included phase 3 and 4 trials of COVID-19 prevention interventions. Early...

Discussing surgical innovation with patients: a qualitative study of surgeons’ and governance representatives’ views

Objectives Little is known about how innovative surgical procedures are introduced and discussed ... more Objectives Little is known about how innovative surgical procedures are introduced and discussed with patients. This qualitative study aimed to explore perspectives on information provision and consent prior to innovative surgical procedures. Design Qualitative study involving semi-structured interviews. Interviews were audio recorded, transcribed and analysed thematically. Participants 42 interviews were conducted (26 surgeons and 16 governance representatives). Setting Surgeons and governance representatives recruited from various surgical specialties and National Health Service (NHS) Trusts across England, UK. Results Participants stated that if a procedure was innovative, patients should be provided with additional information extending beyond that given during routine surgical consultations. However, difficulty defining innovation had implications for whether patients were informed about novel components of surgery and how the procedure was introduced (ie, as part of a research...

Methods of development of a symptom and QOL measure for bowel symptoms: ICIQ-BS

Hypothesis / aims of study Under the aegis of the International Consultation on Incontinence, who... more Hypothesis / aims of study Under the aegis of the International Consultation on Incontinence, whose scientific programmes are organised by the ICS, the ICI Modular Questionnaire (ICIQ) project (www.iciq.net) is developing a comprehensive and universally applicable modular questionnaire for the assessment of a variety of pelvic symptoms, including those of the lower urinary tract, lower bowel and vagina. There are currently no questionnaires that have been sufficiently validated, to adequately measure symptoms and quality of life (QoL) associated with bowel symptoms including anal incontinence (1). The ICIQ-BS intends to address this issue, incorporating various methods at the design stage to improve inclusion of all items of importance to both clinicians and patients. Clinician involvement is essential in order to capture the symptom areas that may be indicative of a functional abnormality. However, although clinicians may be the best observers of the outward manifestations of a tra...

Neurourology and Urodynamics, 2008

Hypothesis / aims of study Under the aegis of the International Consultation on Incontinence, the... more Hypothesis / aims of study Under the aegis of the International Consultation on Incontinence, the ICI Modular Questionnaire (ICIQ) project (www.iciq.net) is developing a comprehensive and universally applicable modular questionnaire for the assessment of a variety of pelvic symptoms, including those of the lower urinary tract, lower bowel and vagina. The ICIQ aims to standardise assessment and promote the widespread use of self-completion questionnaires in clinical practice and research, and to facilitate comparisons between different treatment strategies and different patient groups. A new module to assess anal incontinence symptoms and their impact on quality of life, the ICIQ-B, incorporated the perspectives of both clinical experts and symptomatic patients to devise the draft instrument (1). The studies below describe the psychometric evaluation of the final version of the ICIQ-B.

HRB Open Research

Background: Protocols are an essential document for conducting randomised controlled trials (RCTs... more Background: Protocols are an essential document for conducting randomised controlled trials (RCTs). However, the completeness of the information provided is often inadequate. To help improve the content of trial protocols, an international group of stakeholders published the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Initiative in 2013. Presently, there is increasing use of cohorts and routinely collected data (RCD) for RCTs because these data have the potential to improve efficiencies by facilitating recruitment, simplifying, and reducing the cost of data collection. Reporting guidelines have been shown to improve the quality of reporting, but there is currently no specific SPIRIT guidance on protocols for trials conducted using cohorts and RCD. This protocol outlines steps for developing SPIRIT-ROUTINE, which aims to address this gap by extending the SPIRIT guidance to protocols for trials conducted using cohorts and RCD. Methods: The development ...

HRB Open Research

Background: Outcome heterogeneity, selective reporting, and choosing outcomes that do not reflect... more Background: Outcome heterogeneity, selective reporting, and choosing outcomes that do not reflect needs and priorities of stakeholders, limit the examination of health intervention effects, particularly in late phase trials. Core outcome sets (COS) are a proposed solution to these issues. A COS is an agreed-upon, standardised set of outcomes that should be measured and reported as a minimum in all trials in a specific area of health or healthcare. COS are intended to increase standardisation of outcome measurement and reporting to better enable comparisons between, and synthesis of findings of trials in a particular health area. Methods: This study will examine late phase trials, published between October 2019 and March 2020 (inclusive), in the following five medical journals: New England Journal of Medicine, Journal of the American Medical Association, Lancet, BMJ, and Annals of Internal Medicine. Trials will be examined to determine if they refer to a COS, and whether they use a ...

BMJ Open, 2020

IntroductionOutcome reporting in research studies of breast reconstruction is inconsistent and la... more IntroductionOutcome reporting in research studies of breast reconstruction is inconsistent and lacks standardisation. The results of individual studies therefore cannot be meaningfully compared or combined limiting their value. A core outcome set (COS) has been developed to address these issues and identified 11 key outcomes to be measured and reported in all future research and audit studies in reconstructive breast surgery (RBS). A COS represents what key outcomes should be measured. The next step is to determine how and when this should be done. The aim of this study is to develop a core measurement set (CMS) for use in research and audit studies in implant-based breast reconstruction.Methods and analysisThe CMS will be developed in accordance with the guidance developed by the Core Outcome Measures in Effectiveness Trials initiative (COMET) and COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) group for the selection of outcome measurement instruments (OMIs) for relevant outcome domains included in the RBS COS. This will involve three phases with strategies to promote implementation as a final additional phase. The phases are (1) conceptual considerations in which the target population, procedures and settings are defined; (2) systematic reviews to identify existing clinical, patient-reported and cosmetic OMIs and, if appropriate, assess their quality using COSMIN methodology; (3) a modified Delphi process including sequential Delphi surveys involving approximately 100 healthcare professionals and a face to face consensus meeting to agree and ratify which outcome definitions and OMIs should be used and standardised time points for assessment; (4) strategies to promote dissemination and adoption of the CMS.Ethics and disseminationEthical approval has been granted by University of Bristol Faculty Research Ethics Committee FREC ID 60221. Dissemination strategies will include scientific meeting presentations and peer-reviewed journal publications. Implementation activities will include engagement with journal editors and funders to promote uptake and use of the CMS.

Programme Grants for Applied Research, 2022

Cancer is treated using multiple modalities (e.g. surgery, radiotherapy and systemic therapies) a... more Cancer is treated using multiple modalities (e.g. surgery, radiotherapy and systemic therapies) and is frequently associated with adverse events that affect treatment delivery and quality of life. Regular adverse event reporting could improve care and safety through timely detection and management. Information technology provides a feasible monitoring model, but applied research is needed. This research programme developed and evaluated an electronic system, called eRAPID, for cancer patients to remotely self-report adverse events. The objectives were to address the following research questions: is it feasible to collect adverse event data from patients’ homes and in clinics during cancer treatment? Can eRAPID be implemented in different hospitals and treatment settings? Will oncology health-care professionals review eRAPID reports for decision-making? When added to usual care, will the eRAPID intervention (i.e. self-reporting with tailored advice) lead to clinical benefits (e.g. be...

Appendix A. DevPICv1. Participatory and Informed Consent for trial recruitment. Appendix B. DevPI... more Appendix A. DevPICv1. Participatory and Informed Consent for trial recruitment. Appendix B. DevPICv2. Participatory and Informed Consent for trial recruitment. (PDF 533 kb)

Trials, 2018

Background: Core outcome set (COS) developers increasingly employ Delphi surveys to elicit stakeh... more Background: Core outcome set (COS) developers increasingly employ Delphi surveys to elicit stakeholders' opinions of which outcomes to measure and report in trials of a particular condition or intervention. Research outside of Delphi surveys and COS development demonstrates that question order can affect response rates and lead to 'context effects', where prior questions determine an item's meaning and influence responses. This study examined the impact of question order within a Delphi survey for a COS for oesophageal cancer surgery. Methods: A randomised controlled trial was nested within the Delphi survey. Patients and health professionals were randomised to receive a survey including clinical and patient-reported outcomes (PROs), where the PRO section appeared first or last. Participants rated (1-9) the importance of 68 items for inclusion in a COS (ratings 7-9 considered 'essential'). Analyses considered the impact of question order on: (1) survey response rates; (2) participants' responses; and (3) items retained at end of the survey. Results: In total, 116 patients and 71 professionals returned completed surveys. Question order did not affect response rates among patients, but fewer professionals responded when clinical items appeared first (difference = 31.3%, 95% confidence interval [CI] = 13.6-48.9%, P = 0.001). Question order led to different context effects within patients and professionals. While patients rated clinical items highly, irrespective of question order, more PROs were rated essential when appearing last rather than first (difference = 23.7%, 95% CI = 10.5-40.8%). Among professionals, the greatest impact was on clinical items; a higher percentage rated essential when appearing last (difference = 11.6%, 95% CI = 0.0-23.3%). An interaction between question order and the percentage of PRO/clinical items rated essential was observed for patients (P = 0.025) but not professionals (P = 0.357). Items retained for further consideration at the end of the survey were dependent on question order, with discordant items (retained by one question order group only) observed in patients (18/68 [26%]) and professionals (20/68 [29%]). Conclusions: In the development of a COS, participants' ratings of potential outcomes within a Delphi survey depend on the context (order) in which the outcomes are asked, consequently impacting on the final COS. Initial piloting is recommended with consideration of the randomisation of items in the survey to reduce potential bias. Trial registration: The randomised controlled trial reported within this paper was nested within the development of a core outcome set to investigate processes in core outcome set development. Outcomes were not health-related and trial registration was not therefore applicable.

British Journal of Surgery, 2018

Background Accurate assessment of surgical-site infection (SSI) is crucial for surveillance and r... more Background Accurate assessment of surgical-site infection (SSI) is crucial for surveillance and research. Self-reporting patient measures are needed because current SSI tools are limited for assessing patients after leaving hospital. The Bluebelle Wound Healing Questionnaire (WHQ) was developed for patient or observer completion; this study tested its acceptability, scale structure, reliability and validity in patients with closed primary wounds after abdominal surgery. Methods Patients completed the WHQ (self-assessment) within 30 days after leaving hospital and returned it by post. Healthcare professionals completed the WHQ (observer assessment) by telephone or face-to-face. Questionnaire response rates and patient acceptability were assessed. Factor analysis and Cronbach's α examined scale structure and internal consistency. Test–retest and self- versus observer reliability assessments were performed. Sensitivity and specificity for SSI discrimination against a face-to-face r...

Understanding outcome selection, measurement and reporting for innovative invasive procedures: use of multiple data sources to conceptualize outcome domains for an early-phase surgical intervention core outcome set

The development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (SPIRIT-ROUTINE)

Protocol extended files

Additional file 1: Table S1. of Impact of question order on prioritisation of outcomes in the development of a core outcome set: a randomised controlled trial

Nurses: percentage of items rated essential within the non-comparative and comparative context (a... more Nurses: percentage of items rated essential within the non-comparative and comparative context (a consistency effect). (DOCX 13Â kb)

Additional file 1: of Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI)

Contains details of ethical approvals for the RCTs and ProtecT trial registrations. (DOCX 45 kb)

BMJ Open, 2021

IntroductionThe development of innovative invasive procedures and devices are essential to improv... more IntroductionThe development of innovative invasive procedures and devices are essential to improving outcomes in healthcare. However, how these are introduced into practice has not been studied in detail. The Lotus study will follow a wide range of ‘case studies’ of new procedures and/or devices being introduced into NHS trusts to explore what information is communicated to patients, how procedures are modified over time and how outcomes are selected and reported.Methods and analysisThis qualitative study will use ethnographic approaches to investigate how new invasive procedures and/or devices are introduced. Consultations in which the innovation is discussed will be audio-recorded to understand information provision practice. To understand if and how procedures evolve, they will be video recorded and non-participant observations will be conducted. Post-operative interviews will be conducted with the innovating team and patients who are eligible for the intervention. Audio-recordin...

Associated Universities, through the Laboratory Graduate Participation Program, is greatly apprec... more Associated Universities, through the Laboratory Graduate Participation Program, is greatly appreciated. I also thank Dr. D. A. McClure for encouraging me to apply for the Laboratory Graduate Participation Program. The ORIC staff has been most hospitable and I would like to thank both the professional and technical staffs for their assistance and availability whenever needed. I also thank Miss Helen Dockery for her aid in using the Nuclear Data Group plotting program at ORNL and Mrs. Martha Dawson for her excellent typing of this manuscript. Finally, but certainly not least of all, I would like to thank my wife, Arlene, for her patience and support in every way, during the past two years.

Journal of clinical epidemiology, Jan 16, 2018

To evaluate the impact of the Quintet Recruitment Intervention (QRI) on recruitment in challengin... more To evaluate the impact of the Quintet Recruitment Intervention (QRI) on recruitment in challenging randomized controlled trials (RCTs) that have applied the intervention. The QRI aims to understand recruitment difficulties, and then implements 'QRI-actions' to address these as recruitment proceeds. A mixed-methods study, comprising: a) before-and-after comparisons of recruitment rates and numbers of patients approached, and b) qualitative case studies, including documentary analysis and interviews with RCT investigators. Five UK-based publicly-funded RCTs were included in the evaluation. All recruited to target. RCT2 and RCT5 both received up-front pre-recruitment training before the intervention was applied. RCT2 did not encounter recruitment issues and recruited above target from its outset. Recruitment difficulties, particularly communication issues, were identified and addressed through QRI-actions in RCTs 1, 3, 4 and 5. Randomization rates significantly improved post-QR...

Patient Reported Outcome Measures for Major Lower Limb Amputation Caused by Peripheral Artery Disease or Diabetes: A Systematic Review

Journal of Vascular Surgery, 2021

OBJECTIVE Most major lower limb amputations are related to peripheral artery disease (PAD) or dia... more OBJECTIVE Most major lower limb amputations are related to peripheral artery disease (PAD) or diabetes. Just 40% of patients who undergo major lower limb amputation will use a prosthesis yet measures of surgical success commonly focus on prosthesis use. Patient reported outcome measures (PROMs) are valuable to comprehensively evaluate health related quality of life (HRQL) after surgery. This systematic review aimed to identify and describe PROMs available to assess HRQL in patients after amputation for PAD or diabetes. METHODS A search was conducted based on the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) for systematic reviews of PROMs. Ovid MEDLINE, Ovid EMBASE, PsycINFO, CINAHL, and Cochrane CENTRAL were also searched from inception until August 2019. Included were articles describing the development, measurement properties, or evaluation of HRQL via a PROM in adult patients after amputation for PAD or diabetes. Studies of amputation exclusively for trauma or malignancy were excluded. Data were collected on study characteristics, PROM characteristics (generic/disease specific), and properties of amputation specific PROMs. RESULTS Of 3 317 abstracts screened, 111 full text articles were assessed for eligibility and 64 included. Fifty-six studies evaluated HRQL, with 23 (46%) of these using an amputation specific PROM to do so. Eleven different amputation specific PROMs were identified, 10 (91%) of which were developed only for prosthesis users. One measure was suitable for use in all patients after amputation. This "Amputee single item mobility measure" includes a single item evaluating mobility. Nine studies reported some psychometric testing of an amputation specific PROM. CONCLUSION A well tested, multidimensional PROM applicable to wheelchair and prosthetic users after amputation is lacking and urgently needed for studies in this field. Future work to develop an appropriate measure is required.

A review of the Cochrane COVID-19 Study Register reveals inconsistency in the choice and measurement of SARS-CoV-2 infection outcomes in prevention trials

F1000Research, 2021

Background: Multiple studies are evaluating how to prevent SARS-CoV-2 infection. Interventions ar... more Background: Multiple studies are evaluating how to prevent SARS-CoV-2 infection. Interventions are wide ranging and include vaccines, prophylactic drugs, public health safety measures, and behavioural interventions. Heterogeneity in the outcomes measured and reported is leading to research waste and inefficiency, slowing worldwide identification and implementation of effective methods to prevent infection. A core outcome set (COS) for studies of interventions to prevent SARS-CoV-2 infection has recently been developed, identifying infection as a critical outcome to measure. This paper examines how SARS-CoV-2 infection outcomes are measured in registered COVID-19 prevention trials and considers how this can be improved. Methods: We searched the Cochrane COVID-19 Study Register to identify and review SARS-CoV-2 infection outcomes in prevention trials, including the rationale for choice of outcome measurement. We included phase 3 and 4 trials of COVID-19 prevention interventions. Early...

Discussing surgical innovation with patients: a qualitative study of surgeons’ and governance representatives’ views

Objectives Little is known about how innovative surgical procedures are introduced and discussed ... more Objectives Little is known about how innovative surgical procedures are introduced and discussed with patients. This qualitative study aimed to explore perspectives on information provision and consent prior to innovative surgical procedures. Design Qualitative study involving semi-structured interviews. Interviews were audio recorded, transcribed and analysed thematically. Participants 42 interviews were conducted (26 surgeons and 16 governance representatives). Setting Surgeons and governance representatives recruited from various surgical specialties and National Health Service (NHS) Trusts across England, UK. Results Participants stated that if a procedure was innovative, patients should be provided with additional information extending beyond that given during routine surgical consultations. However, difficulty defining innovation had implications for whether patients were informed about novel components of surgery and how the procedure was introduced (ie, as part of a research...

Methods of development of a symptom and QOL measure for bowel symptoms: ICIQ-BS

Hypothesis / aims of study Under the aegis of the International Consultation on Incontinence, who... more Hypothesis / aims of study Under the aegis of the International Consultation on Incontinence, whose scientific programmes are organised by the ICS, the ICI Modular Questionnaire (ICIQ) project (www.iciq.net) is developing a comprehensive and universally applicable modular questionnaire for the assessment of a variety of pelvic symptoms, including those of the lower urinary tract, lower bowel and vagina. There are currently no questionnaires that have been sufficiently validated, to adequately measure symptoms and quality of life (QoL) associated with bowel symptoms including anal incontinence (1). The ICIQ-BS intends to address this issue, incorporating various methods at the design stage to improve inclusion of all items of importance to both clinicians and patients. Clinician involvement is essential in order to capture the symptom areas that may be indicative of a functional abnormality. However, although clinicians may be the best observers of the outward manifestations of a tra...

Neurourology and Urodynamics, 2008

Hypothesis / aims of study Under the aegis of the International Consultation on Incontinence, the... more Hypothesis / aims of study Under the aegis of the International Consultation on Incontinence, the ICI Modular Questionnaire (ICIQ) project (www.iciq.net) is developing a comprehensive and universally applicable modular questionnaire for the assessment of a variety of pelvic symptoms, including those of the lower urinary tract, lower bowel and vagina. The ICIQ aims to standardise assessment and promote the widespread use of self-completion questionnaires in clinical practice and research, and to facilitate comparisons between different treatment strategies and different patient groups. A new module to assess anal incontinence symptoms and their impact on quality of life, the ICIQ-B, incorporated the perspectives of both clinical experts and symptomatic patients to devise the draft instrument (1). The studies below describe the psychometric evaluation of the final version of the ICIQ-B.

HRB Open Research

Background: Protocols are an essential document for conducting randomised controlled trials (RCTs... more Background: Protocols are an essential document for conducting randomised controlled trials (RCTs). However, the completeness of the information provided is often inadequate. To help improve the content of trial protocols, an international group of stakeholders published the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Initiative in 2013. Presently, there is increasing use of cohorts and routinely collected data (RCD) for RCTs because these data have the potential to improve efficiencies by facilitating recruitment, simplifying, and reducing the cost of data collection. Reporting guidelines have been shown to improve the quality of reporting, but there is currently no specific SPIRIT guidance on protocols for trials conducted using cohorts and RCD. This protocol outlines steps for developing SPIRIT-ROUTINE, which aims to address this gap by extending the SPIRIT guidance to protocols for trials conducted using cohorts and RCD. Methods: The development ...

HRB Open Research

Background: Outcome heterogeneity, selective reporting, and choosing outcomes that do not reflect... more Background: Outcome heterogeneity, selective reporting, and choosing outcomes that do not reflect needs and priorities of stakeholders, limit the examination of health intervention effects, particularly in late phase trials. Core outcome sets (COS) are a proposed solution to these issues. A COS is an agreed-upon, standardised set of outcomes that should be measured and reported as a minimum in all trials in a specific area of health or healthcare. COS are intended to increase standardisation of outcome measurement and reporting to better enable comparisons between, and synthesis of findings of trials in a particular health area. Methods: This study will examine late phase trials, published between October 2019 and March 2020 (inclusive), in the following five medical journals: New England Journal of Medicine, Journal of the American Medical Association, Lancet, BMJ, and Annals of Internal Medicine. Trials will be examined to determine if they refer to a COS, and whether they use a ...

BMJ Open, 2020

IntroductionOutcome reporting in research studies of breast reconstruction is inconsistent and la... more IntroductionOutcome reporting in research studies of breast reconstruction is inconsistent and lacks standardisation. The results of individual studies therefore cannot be meaningfully compared or combined limiting their value. A core outcome set (COS) has been developed to address these issues and identified 11 key outcomes to be measured and reported in all future research and audit studies in reconstructive breast surgery (RBS). A COS represents what key outcomes should be measured. The next step is to determine how and when this should be done. The aim of this study is to develop a core measurement set (CMS) for use in research and audit studies in implant-based breast reconstruction.Methods and analysisThe CMS will be developed in accordance with the guidance developed by the Core Outcome Measures in Effectiveness Trials initiative (COMET) and COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) group for the selection of outcome measurement instruments (OMIs) for relevant outcome domains included in the RBS COS. This will involve three phases with strategies to promote implementation as a final additional phase. The phases are (1) conceptual considerations in which the target population, procedures and settings are defined; (2) systematic reviews to identify existing clinical, patient-reported and cosmetic OMIs and, if appropriate, assess their quality using COSMIN methodology; (3) a modified Delphi process including sequential Delphi surveys involving approximately 100 healthcare professionals and a face to face consensus meeting to agree and ratify which outcome definitions and OMIs should be used and standardised time points for assessment; (4) strategies to promote dissemination and adoption of the CMS.Ethics and disseminationEthical approval has been granted by University of Bristol Faculty Research Ethics Committee FREC ID 60221. Dissemination strategies will include scientific meeting presentations and peer-reviewed journal publications. Implementation activities will include engagement with journal editors and funders to promote uptake and use of the CMS.