scholarly journals Prevailing outcome themes reported by people with degenerative cervical myelopathy: findings from a semi-structured interview (Preprint)

2020 ◽  
Author(s):  
Danyal Zaman Khan ◽  
Siobhan Mairead Fitzpatrick ◽  
Bryn Hilton ◽  
Angus G.K. McNair ◽  
Ellen Sarewitz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cervical Myelopathy ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Consensus Process ◽  
Outcome Set ◽  
Patient Reported ◽  
Degenerative Cervical Myelopathy ◽  
The Impact

BACKGROUND Degenerative cervical myelopathy (DCM) arises when arthritic changes of the cervical spine cause compression and a progressive injury to the spinal cord. It is common and potentially disabling. People with DCM (PwCM) to have amongst the lowest quality of life scores (SF-36) of chronic disease, although the drivers for this are not entirely understood. DCM research faces a number of challenges, including the heterogenous reporting of study data. The AO Spine RECODE-DCM project is an international consensus process that aims improve research efficiency through formation of a core outcome set (COS). A key part of COS development process is organizing outcomes into domains which represent key aspects of the disease. OBJECTIVE To facilitate this, we sought to qualitatively explore the context and impact of patient reported outcomes in DCM on people with DCM (PwCM) and their supporters. The aim was to improve understanding of patient perspective and assist the organisation of outcomes into domains for the consensus process. METHODS A single focus group was hosted by Myelopathy.org, a charity and support group for PwCM. The 40 minute session was audio-recorded and transcribed verbatim. Data was familiarized and 2 authors performed data coding independently. Codes were grouped into themes and a thematic analysis was performed guided by Braun & Clarke’s six-phase approach. The themes were subsequently reviewed with an independent PwCM stakeholder (ES), assisting in the process of capturing the true context and importance of themes. RESULTS Five PwCM (three men and two women) and three supporters (all women) participated. The average PwCM age was 53 and the median mJOA was 11 (±IQR 2), indicating these PwCM had moderate to severe DCM. 54 codes were grouped into 10 themes that captured the impact of DCM on PwCM and their supporters. These themes included: acceptance of symptoms, anticipatory anxiety, coping mechanisms/resilience, feelings of helplessness, financial consequences, lack of recognition, mental health impact, loss of life control, social reclusiveness/isolation and social stigma CONCLUSIONS This is the first study to undertake qualitative analysis of PwCM perspectives. It has highlighted a number of prevailing themes currently unmeasured in clinical research or care. The determinants of low quality of life in DCM are currently unknown, and these findings provide a novel and so far, unique perspective. These perspectives will be used to inform the development of a core outcome set for DCM which is inclusive of all relevant stakeholders, including PwCM.

scholarly journals Outcomes of Degenerative Cervical Myelopathy From The Perspective of Persons Living With the Condition: Findings of a Semistructured Interview Process With Partnered Internet Survey

2020 ◽  
pp. 219256822095381
Author(s):  
Benjamin M. Davies ◽  
Colin Munro ◽  
Danyal Z. Khan ◽  
Siobhan M. Fitzpatrick ◽  
Bryn Hilton ◽  
...  
Keyword(s):  
Focus Group ◽  
Cervical Myelopathy ◽  
Core Outcome Set ◽  
Internet Survey ◽  
Core Outcome ◽  
Semistructured Interview ◽  
Cross Sectional ◽  
Outcome Set ◽  
Degenerative Cervical Myelopathy ◽  
The Impact

Study Design: Mixed-methods cross-sectional study. Objectives: Degenerative cervical myelopathy (DCM) is a common and disabling condition. While classically, assessment and diagnosis has focused on neuromuscular symptoms, many other disabilities have been linked. The aim of this study was to explore the consequences of DCM for those with lived experience, producing a long list to inform the development of a core outcome set for DCM research. Methods: A 2-stage process was used: a focus group session of people with DCM (PwCM) and their supporters (n = 8) discussed the impact of DCM. This was used to develop a preliminary list of consequences, which were then placed into a survey of an online community of DCM sufferers (n = 224). Survey participants were asked to tick the consequences that they had experienced and given the opportunity to submit additional. Additional consequences were reviewed by a group of healthcare professionals and PwCM and included if not already represented. Demographic information including disease severity, age, and sex were captured for sampling comparison. Results: A total of 52 outcomes were identified from the focus group and nominally divided into 2 categories; symptoms (36 outcomes) and handicaps (18 outcomes), and further evaluated using a survey. All outcomes were recognized by at least 5% of respondents. A further 16 outcomes were added following the survey. Conclusions: A list of DCM consequences has been defined from the perspective of PwCM. This will now be evaluated as part of AO Spine RECODE-DCM, an international multistakeholder collaboration to establish a core outcome set for research.

scholarly journals Gathering Global Perspectives to Establish the Research Priorities and Minimum Data Sets for Degenerative Cervical Myelopathy: Sampling Strategy of the First Round Consensus Surveys of AO Spine RECODE-DCM

2021 ◽  
pp. 219256822110475
Author(s):  
Oliver D. Mowforth ◽  
Danyal Z Khan ◽  
Mei Yin Wong ◽  
George A. E. Pickering ◽  
Lydia Dean ◽  
...  
Keyword(s):  
Cervical Myelopathy ◽  
Healthcare Professionals ◽  
Core Outcome Set ◽  
Research Priorities ◽  
Core Outcome ◽  
Core Data ◽  
Minimum Data ◽  
Outcome Set ◽  
Data Elements ◽  
Degenerative Cervical Myelopathy

Study Design Survey. Introduction AO Spine Research Objectives and Common Data Elements for Degenerative Cervical Myelopathy (RECODE-DCM) is an international initiative that aims to accelerate knowledge discovery and improve outcomes by developing a consensus framework for research. This includes defining the top research priorities, an index term and a minimum data set (core outcome set and core data elements set – core outcome set (COS)/core data elements (CDE)). Objective To describe how perspectives were gathered and report the detailed sampling characteristics. Methods A two-stage, electronic survey was used to gather and seek initial consensus. Perspectives were sought from spinal surgeons, other healthcare professionals and people with degenerative cervical myelopathy (DCM). Participants were allocated to one of two parallel streams: (1) priority setting or (2) minimum dataset. An email campaign was developed to advertise the survey to relevant global stakeholder individuals and organisations. People with DCM were recruited using the international DCM charity Myelopathy.org and its social media channels. A network of global partners was recruited to act as project ambassadors. Data from Google Analytics, MailChimp and Calibrum helped optimise survey dissemination. Results Survey engagement was high amongst the three stakeholder groups: 208 people with DCM, 389 spinal surgeons and 157 other healthcare professionals. Individuals from 76 different countries participated; the United States, United Kingdom and Canada were the most common countries of participants. Conclusion AO Spine RECODE-DCM recruited a diverse and sufficient number of participants for an international PSP and COS/CDE process. Whilst PSP and COS/CDE have been undertaken in other fields, to our knowledge, this is the first time they have been combined in one process.

scholarly journals The Impact of Older Age on Functional Recovery and Quality of Life Outcomes after Surgical Decompression for Degenerative Cervical Myelopathy: Results from an Ambispective, Propensity-Matched Analysis from the CSM-NA and CSM-I International, Multi-Center Studies

2019 ◽  
Vol 8 (10) ◽  
pp. 1708 ◽  
Author(s):  
Jamie R. F. Wilson ◽  
Jetan H. Badhiwala ◽  
Fan Jiang ◽  
Jefferson R. Wilson ◽  
Branko Kopjar ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Cervical Myelopathy ◽  
Neck Disability Index ◽  
Older Age ◽  
Functional Improvement ◽  
Increased Risk ◽  
Degenerative Cervical Myelopathy ◽  
The Impact

Background: The effect on functional and quality of life (QOL) outcomes of surgery in elderly degenerative cervical myelopathy (DCM) patients has not been definitively established. Objective: To evaluate the effect of older age on the functional and QOL outcomes after surgery in an international, multi-center cohort of patients with DCM. Methods: 107 patients aged over 70 years old (mean 75.6 ± 4.4 years) were enrolled in the AOSpine CSM-North America and International studies. A propensity-matched cohort of 107 patients was generated from the remaining 650 adults aged <70 years old (mean 56.3 ± 9.6 years), matched to gender, complexity of surgery, co-morbidities, and baseline functional impairment (modified Japanese Orthopedic Association scale (mJOA). Functional, disability, and QOL outcomes were compared at baseline and at two years post-operatively, along with peri-operative adverse events. Results: Both cohorts were equivalently matched. At two years, both cohorts showed significant functional improvement from the baseline but the magnitude was greater in the younger cohort (mJOA 3.8 (3.2–4.4) vs. 2.6 (2.0–3.3); p = 0.007). This difference between groups was also observed in the SF-36 physical component summary (PCS) and mental component summary (MCS) outcomes (p = <0.001, p = 0.007), but not present in the neck disability index (NDI) scores (p = 0.094). Adverse events were non-significantly higher in the elderly cohort (22.4% vs. 15%; p = 0.161). Conclusions: Elderly patients showed an improvement in functional and QOL outcomes after surgery for DCM, but the magnitude of improvement was less when compared to the matched younger adult cohort. An age over 70 was not associated with an increased risk of adverse events.

Functional and Quality of Life Outcomes of Surgery for Degenerative Cervical Myelopathy: a Quality Improvement Study

2020 ◽  
Author(s):  
Babak Mirzashahi ◽  
Pejman Mansouri ◽  
Arvin Najafi ◽  
Saeed Besharati ◽  
Mohammad Taha Kouchakinejad ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cervical Myelopathy ◽  
Short Form ◽  
Sf 36 ◽  
Patient Reported ◽  
Vas Scores ◽  
One Year ◽  
Degenerative Cervical Myelopathy

Background: This study aimed to determine the outcome of surgical treatments in patients with degenerative cervical myelopathy (DCM). During one-year follow-up period, we evaluated patient-reported functional and quality of life (QOL) measures.   Methods: In a retrospective single-center study, we collected data of patients with DCM who underwent cervical fusion surgeries in Imam Khomeini Hospital, Tehran, Iran, from 2011 to 2015. Patients underwent single or multi-level anterior cervical discectomy and fusion (ACDF), anterior cervical corpectomy and fusion (ACCF), or posterior laminectomy and fusion. We utilized patient-reported assessments including Short Form 36 (SF-36), Visual Analogue Scale (VAS), Neck Disability Index (NDI), and Nurick grade. Follow-up was performed at 6 weeks, 3 months, 6 months, and 12 months post-operatively to assess the outcome of surgery.   Results: Ninety patients (56 men, 34 women) with a mean age of 54.1 (27-87) years were included. Comparison of pre- and post-operative scores showed significant improvement in SF-36 parameters, VAS, NDI, and Nurick grade (P < 0.001). Also, women’s VAS scores improved more than men's VAS scores during the follow-up period (P < 0.050). Age and type of surgery did not significantly affect the SF-36 parameters, VAS, NDI, and Nurick grade (P > 0.05).   Conclusions: Cervical surgeries in patients with different severity of DCM can improve different aspects of QOL during one-year after surgery

scholarly journals Core outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG): an international, consensus-derived and multistakeholder initiative

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e043242
Author(s):  
Kirstie Haywood ◽  
Rachel Potter ◽  
Robert Froud ◽  
Gemma Pearce ◽  
Barbara Box ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Healthcare Professionals ◽  
Core Outcome Set ◽  
Episodic Migraine ◽  
Consensus Meeting ◽  
Good Representation ◽  
Core Outcome ◽  
The Core ◽  
Outcome Set

ObjectiveTypically, migraine prevention trials focus on reducing migraine days. This narrow focus may not capture all that is important to people with migraine. Inconsistency in outcome selection across trials limits the potential for data pooling and evidence synthesis. In response, we describe the development of core outcome set for migraine (COSMIG).DesignA two-stage approach sought to achieve international, multistakeholder consensus on both the core domain set and core measurement set. Following construction of a comprehensive list of outcomes, expert panellists (patients, healthcare professionals and researchers) completed a three-round electronic-Delphi study to support a reduction and prioritisation of core domains and outcomes. Participants in a consensus meeting finalised the core domains and methods of assessment. All stages were overseen by an international core team, including patient research partners.ResultsThere was a good representation of patients (episodic migraine (n=34) and chronic migraine (n=42)) and healthcare professionals (n=33) with high response and retention rates. The initial list of domains and outcomes was reduced from >50 to 7 core domains for consideration in the consensus meeting, during which a 2-domain core outcome set was agreed.ConclusionInternational and multistakeholder consensus emerged to describe a two-domain core outcome set for reporting research on preventive interventions for chronic and episodic migraine: migraine-specific pain and migraine-specific quality of life. Intensity of migraine pain assessed with an 11-point Numerical Rating Scale and the frequency as the number of headache/migraine days over a specified time period. Migraine-specific quality of life assessed using the Migraine Functional Impact Questionnaire.

scholarly journals Development of a core outcome set for disease modification trials in mild to moderate dementia: a systematic review, patient and public consultation and consensus recommendations

2017 ◽  
Vol 21 (26) ◽  
pp. 1-192 ◽  
Author(s):  
Lucy Webster ◽  
Derek Groskreutz ◽  
Anna Grinbergs-Saull ◽  
Rob Howard ◽  
John T O’Brien ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Disease Modification ◽  
The Core ◽  
Moderate Dementia ◽  
Outcome Set ◽  
Core Set ◽  
And Biological Markers

BackgroundThere is currently no disease-modifying treatment available to halt or delay the progression of the disease pathology in dementia. An agreed core set of the best-available and most appropriate outcomes for disease modification would facilitate the design of trials and ensure consistency across disease modification trials, as well as making results comparable and meta-analysable in future trials.ObjectivesTo agree a set of core outcomes for disease modification trials for mild to moderate dementia with the UK dementia research community and patient and public involvement (PPI).Data sourcesWe included disease modification trials with quantitative outcomes of efficacy from (1) references from related systematic reviews in workstream 1; (2) searches of the Cochrane Dementia and Cognitive Improvement Group study register, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Latin American and Caribbean Health Sciences Literature and PsycINFO on 11 December 2015, and clinical trial registries [International Standard Randomised Controlled Trial Number (ISRCTN) and clinicaltrials.gov] on 22 and 29 January 2016; and (3) hand-searches of reference lists of relevant systematic reviews from database searches.Review methodsThe project consisted of four workstreams. (1) We obtained related core outcome sets and work from co-applicants. (2) We systematically reviewed published and ongoing disease modification trials to identify the outcomes used in different domains. We extracted outcomes used in each trial, recording how many used each outcome and with how many participants. We divided outcomes into the domains measured and searched for validation data. (3) We consulted with PPI participants about recommended outcomes. (4) We presented all the synthesised information at a conference attended by the wider body of National Institute for Health Research (NIHR) dementia researchers to reach consensus on a core set of outcomes.ResultsWe included 149 papers from the 22,918 papers screened, referring to 125 individual trials. Eighty-one outcomes were used across trials, including 72 scales [31 cognitive, 12 activities of daily living (ADLs), 10 global, 16 neuropsychiatric and three quality of life] and nine biological techniques. We consulted with 18 people for PPI. The conference decided that only cognition and biological markers are core measures of disease modification. Cognition should be measured by the Mini Mental State Examination (MMSE) or the Alzheimer’s Disease Assessment Scale – Cognitive subscale (ADAS-Cog), and brain changes through structural magnetic resonance imaging (MRI) in a subset of participants. All other domains are important but not core. We recommend using the Neuropsychiatric Inventory for neuropsychiatric symptoms: the Disability Assessment for Dementia for ADLs, the Dementia Quality of Life Measure for quality of life and the Clinical Dementia Rating scale to measure dementia globally.LimitationsMost of the trials included participants with Alzheimer’s disease, so recommendations may not apply to other types of dementia. We did not conduct economic analyses. The PPI consultation was limited to members of the Alzheimer’s Society Research Network.ConclusionsCognitive outcomes and biological markers form the core outcome set for future disease modification trials, measured by the MMSE or ADAS-Cog, and structural MRI in a subset of participants.Future workWe envisage that the core set may be superseded in the future, particularly for other types of dementia. There is a need to develop an algorithm to compare scores on the MMSE and ADAS-Cog.Study registrationThe project was registered with Core Outcome Measures in Effectiveness Trials [www.comet-initiative.org/studies/details/819?result=true(accessed 7 April 2016)]. The systematic review protocol is registered as PROSPERO CRD42015027346.FundingThe National Institute for Health Research Health Technology Assessment programme.

scholarly journals A core outcome set for aphasia treatment research: The ROMA consensus statement

2018 ◽  
Vol 14 (2) ◽  
pp. 180-185 ◽  
Author(s):  
Sarah J Wallace ◽  
Linda Worrall ◽  
Tanya Rose ◽  
Guylaine Le Dorze ◽  
Caterina Breitenstein ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Consensus Statement ◽  
Outcome Measurement ◽  
Core Outcome Set ◽  
Core Outcome ◽  
International Consensus ◽  
Patient Reported ◽  
Treatment Research ◽  
Aphasia Treatment

Background A core outcome set (COS; an agreed, minimum set of outcomes) was needed to address the heterogeneous measurement of outcomes in aphasia treatment research and to facilitate the production of transparent, meaningful, and efficient outcome data. Objective The Research Outcome Measurement in Aphasia (ROMA) consensus statement provides evidence-based recommendations for the measurement of outcomes for adults with post-stroke aphasia within phases I–IV aphasia treatment studies. Methods This statement was informed by a four-year program of research, which comprised investigation of stakeholder-important outcomes using consensus processes, a scoping review of aphasia outcome measurement instruments, and an international consensus meeting. This paper provides an overview of this process and presents the results and recommendations arising from the international consensus meeting. Results Five essential outcome constructs were identified: Language, communication, patient-reported satisfaction with treatment and impact of treatment, emotional wellbeing, and quality of life. Consensus was reached for the following measurement instruments: Language: The Western Aphasia Battery Revised (WAB-R) (74% consensus); emotional wellbeing: General Health Questionnaire (GHQ)-12 (83% consensus); quality of life: Stroke and Aphasia Quality of Life Scale (SAQOL-39) (96% consensus). Consensus was unable to be reached for measures of communication (where multiple measures exist) or patient-reported satisfaction with treatment or impact of treatment (where no measures exist). Discussion Harmonization of the ROMA COS with other core outcome initiatives in stroke rehabilitation is discussed. Ongoing research and consensus processes are outlined. Conclusion The WAB-R, GHQ-12, and SAQOL-39 are recommended to be routinely included within phases I–IV aphasia treatment studies. This consensus statement has been endorsed by the Collaboration of Aphasia Trialists, the British Aphasiology Society, the German Society for Aphasia Research and Therapy, and the Royal College of Speech Language Therapists.

The effect of surgery in tenosynovial giant cell tumours as measured by patient-reported outcomes on quality of life and joint function

2019 ◽  
Vol 101-B (3) ◽  
pp. 272-280 ◽  
Author(s):  
F. G. M. Verspoor ◽  
M. J. L. Mastboom ◽  
G. Hannink ◽  
W. T. A. van der Graaf ◽  
M. A. J. van de Sande ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Giant Cell ◽  
Diffuse Type ◽  
Joint Function ◽  
Population Means ◽  
Sf 36 ◽  
Patient Reported ◽  
The Impact

Aims The aim of this study was to evaluate health-related quality of life (HRQoL) and joint function in tenosynovial giant cell tumour (TGCT) patients before and after surgical treatment. Patients and Methods This prospective cohort study run in two Dutch referral centres assessed patient-reported outcome measures (PROMs; 36-Item Short-Form Health Survey (SF-36), visual analogue scale (VAS) for pain, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)) in 359 consecutive patients with localized- and diffuse-type TGCT of large joints. Patients with recurrent disease (n = 121) and a wait-and-see policy (n = 32) were excluded. Collected data were analyzed at specified time intervals preoperatively (baseline) and/or postoperatively up to five years. Results A total of 206 TGCT patients, 108 localized- and 98 diffuse-type, were analyzed. Median age at diagnosis of localized- and diffuse-type was 41 years (interquartile range (IQR) 29 to 49) and 37 years (IQR 27 to 47), respectively. SF-36 analyses showed statistically significant and clinically relevant deteriorated preoperative and immediate postoperative scores compared with general Dutch population means, depending on subscale and TGCT subtype. After three to six months of follow-up, these scores improved to general population means and continued to be fairly stable over the following years. VAS scores, for both subtypes, showed no statistically significant or clinically relevant differences pre- or postoperatively. In diffuse-type patients, the improvement in median WOMAC score was statistically significant and clinically relevant preoperatively versus six to 24 months postoperatively, and remained up to five years’ follow-up. Conclusion Patients with TGCT report a better HRQoL and joint function after surgery. Pain scores, which vary hugely between patients and in patients over time, did not improve. A disease-specific PROM would help to decipher the impact of TGCT on patients’ daily life and functioning in more detail. Cite this article: Bone Joint J 2019;101-B:272–280.

Patients With a History of Oronasal Fistula Repair Exhibit Lower Oral Health Measured With Patient-Centric Outcomes Measures

2020 ◽  
pp. 105566562098133
Author(s):  
Alyssa Fritz ◽  
Diana S. Jodeh ◽  
Fatima Qamar ◽  
James J. Cray ◽  
S. Alex Rottgers
Keyword(s):  
Quality Of Life ◽  
Oral Health ◽  
Cleft Palate ◽  
Fistula Repair ◽  
Old Patients ◽  
Oronasal Fistula ◽  
Patient Reported ◽  
History Of ◽  
The Impact

Introduction: Oronasal fistulae following palatoplasty may affect patients’ quality of life by impacting their ability to eat, speak, and maintain oral hygiene. We aimed to quantify the impact of previous oronasal fistula repair on patients’ quality of life using patient-reported outcome psychometric tools. Methods: A cross-sectional study of 8- to 9-year-old patients with cleft palate and/or lip was completed. Patients who had a cleft team clinic between September 2018 and August 2019 were recruited. Participants were divided into 2 groups (no fistula, prior fistula repair). Differences in the individual CLEFT-Q and Child Oral Health Impact Profile-Short Form 19 (COHIP-SF 19) Oral Health scores between the 2 groups were evaluated using a multivariate analysis controlling for Veau classification and syndromic diagnosis. Results: Sixty patients with a history of cleft palate were included. Forty-two (70%) patients had an associated cleft lip. Thirty-two (53.3%) patients had no history of fistula and 28 (46.7%) patients had undergone a fistula repair. CLEFT-Q Dental, Jaw, and Speech Function were all higher in patients without a history of a fistula repair; however, none of these differences were statistically significant. The COHIP-SF 19 Oral Health score demonstrated a significantly lower score in the fistula group, indicating poorer oral health ( P = .05). Conclusions: One would expect that successful repair of a fistula would result in improved function and patient satisfaction, but the consistent trend toward lower CLEFT-Q scores and significantly increased COHIP-SF 19 Oral Health scores in our study group suggests that residual effects linger and that the morbidity of a fistula may not be completely treated with a secondary correction.

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