P487 Development and validation of a new patient-reported outcome measure for Crohn’s perianal fistula: Crohn’s anal fistula quality-of-life (CAF-QoL) scale

Abstract Background Crohn’s perianal fistulas are challenging for patients and clinicians. Many do not respond to available treatments, and despite recommendations by a recent global consensus, there are currently no specific patient-derived quality of life (QoL) tools to measure outcomes including response to treatment, in patients with Crohn’s perianal fistulas. Exploratory qualitative work has demonstrated that Crohn’s perianal fistulas reduce QoL far beyond restricting daily and sexual activities, and a patient-centred, patient-derived tool is needed. We present a patient-reported outcomes measure (PROM) for this complicated disease phenotype. Methods A 35 item draft questionnaire was generated using information from: (a) unstructured qualitative patient interviews, exploring the experience of living with Crohn’s perianal fistulas; (b) a consensus exercise analysing outcomes from a systematic review of studies assessing medical, surgical and combined (medical/surgical) treatment of Crohn’s perianal fistula; and (c) a patient and public involvement meeting. Psychometric properties were assessed including construct validity (by comparison with the Hospital Anxiety and Depression Scale, HADS and the United Kingdom version of the Inflammatory Bowel Disease Questionnaire, UK-IBDQ), and reliability and responsiveness assessed by test-retest analysis. Results Data from 211 patients contributed to the development of the CAF-QoL scale, following the collation of items including patient experience interviews, a systematic review and a consensus exercise involving 187 stakeholders (patients, gastroenterologists, surgeons, IBD specialist nurses, radiologists). Internal consistency was good with Cronbach’s α of 0.88. Analysis aided reduction of the questionnaire to 26 items that demonstrated good internal consistency, good stability (intra-class correlation 0.98) and good construct validity and responsiveness with positive correlation with the UK IBDQ and HADS. Conclusion A disease-specific PROM to assess clinical outcome (i.e. QoL) as baseline and following interventions in patients with Crohn’s anal fistula—the CAF-QoL—is ready for use. Translation and cross-cultural validation will aid wider international dissemination.

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Development and initial psychometric validation of a patient-reported outcome measure for Crohn’s perianal fistula: the Crohn’s Anal Fistula Quality of Life (CAF-QoL) scale

Gut ◽

10.1136/gutjnl-2019-320553 ◽

2020 ◽

pp. gutjnl-2019-320553

Author(s):

Samuel O Adegbola ◽

Lesley Dibley ◽

Kapil Sahnan ◽

Tiffany Wade ◽

Azmina Verjee ◽

...

Keyword(s):

Quality Of Life ◽

Construct Validity ◽

Anal Fistula ◽

Outcome Measure ◽

Perianal Fistula ◽

Patient Reported Outcome ◽

Patient Reported Outcome Measure ◽

Patient Reported ◽

The Uk

IntroductionCrohn’s perianal fistulas are challenging for patients and clinicians. Many do not respond to available treatments and despite recommendations by a global consensus, there are currently no specific patient-derived quality of life tools to measure response to treatment. We present a new validated patient-reported outcome measure (PROM) for this complicated disease phenotype.MethodsA draft questionnaire was generated using unstructured qualitative patient interviews on the experience of living with Crohn’s perianal fistula, a nationwide multidisciplinary consensus exercise, a systematic review of outcomes assessing medical/surgical/combined treatment and a patient and public involvement day. Psychometric properties were assessed including construct validity (by comparison with the Hospital Anxiety and Depression Scale (HADS) and the UK Inflammatory Bowel Disease Questionnaire (UK-IBDQ)), and reliability and responsiveness was assessed by test–retest analysis.ResultsData from 211 patients contributed to development of a final 28-item questionnaire. The Crohn’s Anal Fistula Quality of Life (CAF-QoL) demonstrated good internal consistency (Cronbach’s alpha 0.88), excellent stability (intraclass correlation 0.98) and good responsiveness and construct validity, with positive correlation with the UK-IBDQ and HADS.ConclusionThe CAF-QoL scale is ready for use as a PROM in research and clinical practice. It complements objective clinical evaluation of fistula by capturing impact on the patient.

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Burden of disease and adaptation to life in patients with Crohn’s perianal fistula: a qualitative exploration

Health and Quality of Life Outcomes ◽

10.1186/s12955-020-01622-7 ◽

2020 ◽

Vol 18 (1) ◽

Cited By ~ 1

Author(s):

Samuel O. Adegbola ◽

Lesley Dibley ◽

Kapil Sahnan ◽

Tiffany Wade ◽

Azmina Verjee ◽

...

Keyword(s):

Quality Of Life ◽

Perianal Fistula ◽

Well Being ◽

Definitive Treatment ◽

Emotional Impact ◽

Published Data ◽

Perianal Fistulas ◽

Patient Reported ◽

The Impact

Abstract Background Perianal fistulas are a challenging manifestation of Crohn’s disease. Best medical and surgical therapy results in only about a third of patients remaining in remission at one year on maintenance treatment and sustained healing is often elusive. There is little published data on patient perspective of living with the condition or coping strategies in the face of non-curative/non-definitive treatment. We aimed to understand the experience of living with perianal fistula(s) and their impact on quality of life and routine functioning. Methods This exploratory qualitative study used purposive sampling to recruit participants with current / previous diagnosis of Crohn’s anal fistulas, from national IBD / bowel disease charities. The “standards for reporting qualitative research” (SRQR) recommendations were followed. Unstructured individual face-to-face interviews were audio recorded, transcribed and analysed thematically. Early themes were reviewed by the study team including patient advocates, clinicians and qualitative researchers. Results Twelve interviews were conducted, achieving apparent data saturation. Three broad themes were uncovered: Burden of symptoms; Burden of treatment; and Impact on emotional, physical and social well-being. Each included several sub-themes, with considerable interplay between these. The impact of perianal fistula(s) on patients with CD is intense and wide reaching, negatively affecting intimate, close and social relationships. Fistulas cause losses in life and work-related opportunities, and treatments can be difficult to tolerate. Conclusion Crohn’s perianal fistulas exert a heavy negative physical and emotional impact on patients. These findings will inform development of a patient reported outcome measure to assess treatment effectiveness and quality of life for patients living with this challenging condition.

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Validation of the Bronchiectasis Impact Measure (BIM) – a novel patient reported outcome measure

European Respiratory Journal ◽

10.1183/13993003.03156-2020 ◽

2020 ◽

pp. 2003156

Author(s):

Megan L. Crichton ◽

Emily K. Dudgeon ◽

Amelia Shoemark ◽

James D. Chalmers

Keyword(s):

Quality Of Life ◽

Construct Validity ◽

Acute Exacerbation ◽

Internal Consistency ◽

General Health ◽

Outcome Measure ◽

Patient Reported Outcome ◽

Patient Reported ◽

Impact Measure

IntroductionExisting quality of life and symptom tools used in bronchiectasis trials are either not disease specific or are complex and have not been consistently responsive. We developed a simple patient reported visual analogue outcome measure, the bronchiectasis impact measure (BIM) for use in clinical research including clinical trials.MethodsPatients with bronchiectasis attending a tertiary referral clinic in the East of Scotland were invited to complete the BIM questionnaire and the Quality of life bronchiectasis questionnaire at baseline with repeat questionnaires after 2 weeks and 6 months. We assessed internal consistency, test-retest reliability, construct validity and responsiveness by evaluating change during an acute exacerbation.Results173 patients were included. The 8 domains (Cough, sputum, breathlessness, tiredness, activity, general health, control, exacerbations) showed excellent internal consistency (Cronbach α 0.93). The intraclass correlation coefficient (ICC) demonstrated excellent reliability over a 2-week period, cough (0.79 (95%CI 0.70–0.85)), sputum (0.86 (95%CI 0.80–0.90)), dyspnoea (0.82 (95%CI 0.74–0.87)), tiredness (0.88 (95%CI 0.82–0.91)), activity (0.84 (95%CI 0.77–0.89)), general health (0.81 (95%CI 0.74–0.87)), control (0.83 (95%CI (0.75–0.88)) and exacerbation (0.71 (95%CI (0.60–0.79)). Domains correlated strongly with bronchiectasis severity and exacerbation history. Both distribution and patient-based methods estimated the MCID for each domain as 1.5 points on a 10-point scale. Statistically significant changes in all BIM domains were observed during an acute exacerbation.ConclusionThe BIM is a simple patient reported outcome. This study validates the internal consistency, reliability, construct validity and response of the tool at acute exacerbation. Further validation of the tool is now required.

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Translation and psychometric performance of the Serbian version of the Sarcopenia Quality of Life (SarQoL®) questionnaire

Srpski arhiv za celokupno lekarstvo ◽

10.2298/sarh200924114m ◽

2020 ◽

pp. 114-114

Author(s):

Radmila Matijevic ◽

Olivera Hrnjakovic ◽

Aleksa Djurdjevic ◽

Anton Geerinck ◽

Charlotte Beaudart ◽

...

Keyword(s):

Quality Of Life ◽

High Risk ◽

Construct Validity ◽

Internal Consistency ◽

Handgrip Strength ◽

Community Dwelling ◽

Psychometric Performance ◽

Patient Reported ◽

Ceiling Effects

Introduction/Objective. The Sarcopenia Quality of Life (SarQoL?) questionnaire is a patient-reported outcome measure specific to sarcopenia. The objective was to translate the SarQoL? questionnaire from English into Serbian and to investigate its psychometric performance. Methods. A five-stage forward-backward methodology with pre-test was used to translate the questionnaire. The validation sample in this study consisted of elderly, community-dwelling volunteers of both sexes. Three methods were used to screen for and diagnose sarcopenia: the SARC-F questionnaire (high/low risk), low handgrip strength [probable sarcopenia in the Working Group on Sarcopenia in Older People (EWGSOP2) algorithm], and the complete EWGSOP2 criteria. We investigated the questionnaire?s discriminative power, internal consistency, construct validity, and floor and ceiling effects. Results. The SarQoL? questionnaire was translated into Serbian. The validation study included 699 participants. In total, 200 participants were considered to be at high risk of sarcopenia by the SARC-F, 84 were diagnosed with low handgrip strength and 12 were confirmed to be sarcopenic. We did not find significantly lower overall QoL scores using the EWGSOP2 criteria (60.31 vs. 64.60; p = 0.155). We did find lower scores for the probably sarcopenic group (52.80 vs. 65.50; p < 0.001) and the high-risk group (50.91 vs. 69.02; p < 0.001). The Cronbach?s ? coefficient was 0.87, indicating a high internal consistency. Construct validity was adequate, with 75% of hypotheses on expected correlations with the SF-36 and EQ-5D questionnaires confirmed. No floor or ceiling effects were observed. Conclusion. We successfully translated the SarQoL? into Serbian, and showed that it is a valid tool for measuring QoL in the community-dwelling elderly.

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An assessment of the use of patient reported outcome measurements (PROMs) in cancers of the pelvic abdominal cavity: identifying oncologic benefit and an evidence-practice gap in routine clinical practice

Health and Quality of Life Outcomes ◽

10.1186/s12955-020-01648-x ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Miss Charlotte L. Moss ◽

Ajay Aggarwal ◽

Asad Qureshi ◽

Benjamin Taylor ◽

Teresa Guerrero-Urbano ◽

...

Keyword(s):

Quality Of Life ◽

Systematic Review ◽

Abdominal Cavity ◽

Patient Reported Outcome ◽

Oncologic Outcomes ◽

Review Of The Literature ◽

Outcome Measurements ◽

Patient Reported ◽

Cancer Setting

Abstract Background Patient reported outcome measurements (PROMs) are emerging as an important component of patient management in the cancer setting, providing broad perspectives on patients’ quality of life and experience. The use of PROMs is, however, generally limited to the context of randomised control trials, as healthcare services are challenged to sustain high quality of care whilst facing increasing demand and financial shortfalls. We performed a systematic review of the literature to identify any oncological benefit of using PROMs and investigate the wider impact on patient experience, in cancers of the pelvic abdominal cavity specifically. Methods A systematic review of the literature was conducted using MEDLINE (Pubmed) and Ovid Gateway (Embase and Ovid) until April 2020. Studies investigating the oncological outcomes of PROMs were deemed suitable for inclusion. Results A total of 21 studies were included from 2167 screened articles. Various domains of quality of life (QoL) were identified as potential prognosticators for oncologic outcomes in cancers of the pelvic abdominal cavity, independent of other clinicopathological features of disease: 3 studies identified global QoL as a prognostic factor, 6 studies identified physical and role functioning, and 2 studies highlighted fatigue. In addition to improved outcomes, a number of included studies also reported that the use of PROMs enhanced both patient-clinician communication and patient satisfaction with care in the clinical setting. Conclusions This review highlights the necessity of routine collection of PROMs within the pelvic abdominal cancer setting to improve patient quality of life and outcomes.

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Mini-Implant-Retained Overdentures for the Rehabilitation of Completely Edentulous Maxillae: A Systematic Review and Meta-Analysis

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18084377 ◽

2021 ◽

Vol 18 (8) ◽

pp. 4377

Author(s):

Serena Vi ◽

Damon Pham ◽

Yu Yian Marina Du ◽

Himanshu Arora ◽

Santosh Kumar Tadakamadla

Keyword(s):

Quality Of Life ◽

Systematic Review ◽

Survival Rate ◽

Data Extraction ◽

Meta Analysis ◽

Empirical Studies ◽

Implant Survival ◽

Patient Reported ◽

Full Text Review

Purpose: Mini-dental implants (MDIs) have been used to support and retain overdentures, providing patients with a less invasive placement procedure. Although lucrative, the use of MDIs to retain a maxillary overdenture is still not an established treatment modality. This systematic review aims to answer the question: Do mini-implant-retained maxillary overdentures provide a satisfactory treatment outcome for complete edentulism? Methods: A systematic search for relevant articles was conducted to include articles published until April 2021 in the following electronic databases: CINAHL, Cochrane, EMBASE, PubMed, and Web of Science. All empirical studies evaluating the biological, survival, or patient-reported outcomes after placing mini-implant-retained overdentures in maxilla were considered for inclusion. The risk of bias was assessed by utilizing the Joanna Briggs Institute critical appraisal checklist. Study screening and data extraction were conducted by three reviewers independently. Results: The electronic search retrieved 1276 titles after omitting duplicates. Twenty articles were considered for full-text review, of which six studies were included in this systematic review. The included studies evaluated a total of 173 participants with a mean age of 66.3 years. The overall mini-implant survival rate was 77.1% (95% CI: 64.7–89.5%) with a mean follow-up time of 1.79 years (range: 6 months to 3 years). Implant survival differed significantly when comparing complete and partial palatal coverage overdentures. Those with complete palatal coverage exhibited less bone loss overall compared to partial coverage overdentures. Participants of all studies reported an increase in the quality of life and in satisfaction after rehabilitation treatment with MDIs. Conclusions: The survival rate of mini-implants retaining an overdenture in the maxilla was observed to be lower than the values reported for traditional implants in the literature. Improvements were observed in all aspects in terms of patient satisfaction, quality of life, oromyofunction, and articulation after the treatment.

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Trends in Hidradenitis Suppurativa Disease Severity and Quality of Life Outcome Measures: A Systematic Review (Preprint)

10.2196/preprints.27869 ◽

2021 ◽

Author(s):

Jalal Maghfour ◽

Torunn Elise Sivesind ◽

Cory A. Dunnick ◽

Robert Paul Dellavalle

Keyword(s):

Quality Of Life ◽

Systematic Review ◽

Disease Severity ◽

Outcome Measures ◽

Hidradenitis Suppurativa ◽

Life Quality ◽

Clinical Score ◽

Validity And Reliability ◽

Patient Reported

BACKGROUND While there has been an increase in the number of randomized, controlled trials (RCTs) evaluating treatment efficacy for HS, instrument measurements of disease severity and quality of life (QoL) are varied, making compilation of data and comparison between studies a challenge for clinicians. OBJECTIVE The aim of this review is to evaluate trends in disease severity scales and patient reported outcome measures used in RCTs assessing treatment interventions among HS patients. METHODS A primary systematic literature review was conducted in August 2020. PubMed/MEDLINE, Embase, Web of Science, and Cochrane databases were used to identify all articles published from January 1964 to July 2020. The study was prospectively registered with PROSPERO (ID: 209582). Twenty-five articles were included in the systematic review. RESULTS Sartorius and modified Sartorius scores (n=8), and Hidradenitis Suppurativa Clinical score (HiSCs) (n=8) were the most commonly used instruments for disease severity. Participants’ pain, followed by Dermatology Life Quality Index (DLQI), were the most common QoL measures used in the reviewed studies. CONCLUSIONS Heterogeneity of data characterizing both the validity and reliability of existing outcome measures hinders interpretation and translation of the results from RCTs into clinical practice. Many of the QoL measures identified were not specific to HS and may not be representative of all factors impacting patients.

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The current trend of administering a patient-generated index in the oncological setting: a systematic review

Oncology Reviews ◽

10.4081/oncol.2014.245 ◽

2014 ◽

Cited By ~ 6

Author(s):

Jessica A. Tang ◽

Taemin Oh ◽

Justin K. Scheer ◽

Andrew T. Parsa

Keyword(s):

Quality Of Life ◽

Systematic Review ◽

Current Trend ◽

Free Form ◽

Patient Generated Index ◽

Novel Approach ◽

Patient Reported ◽

Assess Quality ◽

In The Beginning

The patient-generated index (PGI) is a more novel approach to evaluating health-related quality of life (HRQOL) that allows patients to formulate their own responses in an open-ended format in order to measure HRQOL based on each patient’s own stated goals and expectations. To date the use of PGI in the setting of patients diagnosed with cancer remains relatively less common compared to other health conditions. This systematic review primarily aims to identify current literature in which PGI has been used as a tool to assess quality of life in cancer patients. A systematic review using the MEDLINE database from January 1990 to July 2013 was performed with the following search terms to identify the implementation of PGI in oncology settings: (PGI OR patient generated index OR patient-generated OR patient-reported OR patient generated OR patient reported) AND (cancer OR oncology OR tumor OR neoplasm OR malignancy). Of the 2167 papers initially identified, 10 papers evaluated quality of life in oncology patients by collecting free-form responses from the patient, 4 of which actually used PGI. An overarching theme observed in these studies highlighted the concerns mentioned by patients that were not targeted or detected by standardized quality of life measures. While implementing the PGI may require slightly more investment of resources in the beginning, the potential implications of allowing patients to characterize their quality of life on their own terms are tremendous.

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Patient Reported Outcome Measures Assessing Health-Related Quality Of Life in Dupuytren´S Disease: A Systematic Review

International Journal of Innovative Research in Medical Science ◽

10.23958/ijirms/vol05-i01/803 ◽

2020 ◽

Vol 5 (01) ◽

Author(s):

Diego Gómez Herrero ◽

Rafael Sanjuan-Cerveró ◽

Pedro Vazquez-Ferreiro ◽

Francisco Javier Carrera-Hueso ◽

Marina Sáez-Belló ◽

...

Keyword(s):

Quality Of Life ◽

Systematic Review ◽

Outcome Measures ◽

Patient Reported Outcome Measures ◽

Measurement Properties ◽

Health Related Quality ◽

Patient Reported ◽

Related Quality ◽

Health Related

Objective: The objective of this study is to carry out a systematic review of the outcome measures reported by the patient that are used to measure the quality of life of patients with Dupuytren´s disease (DD), assessing their relevance and effectiveness. Methods: A systematic literature search was carried out in the PubMed®, Web of Sciencie®, SciELO®, EMBASE®, Google Scholar® and Cochrane® databases. We searched for peer-reviewed articles evaluating health related quality of life (HR-QoL) in patients with DD diagnosed and/or treated until April 1, 2017, for English or Spanish language. The following keywords were used: “Dupuytren´s disease (MeSH)” AND “health related quality of life (MeSH)”. The documents were eligible for inclusion if they described data on the HR-QoL domains in relation to diagnosis or treatment of DD after a revision process by two independent authors. The checklist (STROBE) was used to evaluate the quality of the works. Results: From 352 identified articles were finally selected 26 studies in the systematic review, mostly European. A total of nine outcomes measures specifically reported by the patient were identified: DASH (used in 13 of the 26 selected studies), Quick-DASH (8/26), MHQ (7/26), briefMHQ (1/26), URAM (4/26), POS-HAND/ARM (1/26), SDSS (1/26), DDSP (1/26) and CHFS (1/26) questionnaires. We analyze their quantitative results to evaluate the effectiveness and evaluate the methodological quality of the studies on the measurement properties of the results reported by patients related to health. Conclusion: More work is urgently needed in these areas before we can reach a consensus on which instrument is the best to assess functional deterioration and improvement in patients with DD.

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Determinants of Cancer-specific Quality of Life in Veteran Lung Cancer Survivors Eligible for Long-Term Cure

10.1101/518910 ◽

2019 ◽

Author(s):

Duc Ha ◽

Andrew L. Ries ◽

Jeffrey J. Swigris

Keyword(s):

Quality Of Life ◽

Lung Cancer ◽

Cancer Survivors ◽

Summary Score ◽

European Organization ◽

Specific Patient ◽

Patient Reported ◽

Sleep Difficulties

AbstractRationale/ObjectiveQuality of life (QoL) is an important issue in lung cancer survivors. We aimed to identify determinants of QoL in lung cancer survivors eligible for long-term cure.MethodsWe performed an exploratory analysis of a cross-sectional study of consecutive lung cancer survivors who completed curative-intent treatment ≥1 month previously. Variables tested included demographic, clinical, physiologic, and symptom-specific patient-reported outcome measures. We defined the primary outcome as a previously-validated cancer-specific QoL measure – the European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (C30) summary score. We also verified our findings with the C30 global health status/QoL subscale and a summated score of lung cancer-specific QoL from the EORTC-Lung Cancer Module 13.ResultsIn 75 enrolled participants, measures of fatigue, depression, sleep difficulties, and dyspnea were statistically significant determinants of the C30 summary score in multivariable linear regression analyses. Together, these four symptoms accounted for approximately 85% of the variance in cancer-specific QoL (p<0.001). When we verified our findings with global QoL and lung cancer-specific QoL, fatigue and dyspnea were consistent determinants of QoL.ConclusionsWe found four symptoms – dyspnea, fatigue, depression, and sleep difficulties – that are important determinants of and together accounted for almost all of the variance in cancer-specific QoL in lung cancer survivors eligible for long-term cure. These findings have implications to reduce symptom burden and improve function and QoL in these patients.

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