ORCID Profile
0000-0002-4637-4572
Current Organisations
University of Sydney
,
University of Leeds
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Publisher: Wiley
Date: 14-12-2020
DOI: 10.1111/WRR.12787
Abstract: Venous leg ulcers (VLUs) are a common chronic often undertreated condition, which affects in idual's health-related quality of life (HRQoL). Numerous patient-reported outcome measures (PROMs) have been validated to capture HRQoL in patients with VLUs. However, available instruments contain many items, are hard to use in clinical practice, and present with weak responsiveness. This study aims to determine clinical utility of an existing VLU-QoL instrument and to develop a comprehensive PROs assessment framework to guide clinical practice treatment in people with VLUs in Australia. Semi-structured qualitative interviews were conducted with VLU patients (N = 13) and their managing clinicians (N = 6) in Victoria, Australia. Interview topics covered content and face validity, appropriateness, and acceptability of the VLU-QoL instrument to determine suitable and appropriate for use in clinical practice. Clinicians and patients agreed that a VLU-QoL instrument was needed in clinical practice. Both clinicians and patients agreed it would be appropriate to answer PROMs questions prior to consultation with clinicians every 3-6 months. However, patients considered that some of the questions are ambiguous and too technical. Patients reported that it would be useful to include additional items relating to daily wound care, compression bandaging, and dressings. Clinicians reported that the VLU-QoL instrument was too long and required restructuring to facilitate utility in practice. A conceptual framework for HRQoL in VLUs included traditional HRQoL components and VLU-specific issues. Overall, the VLU-QoL was well accepted, although changes to make it more concise, comprehensive, and to clearly reflect consumers' perspectives were lacking. The proposed conceptual framework will inform the development of a new PROM for use by clinicians and patients in clinical settings.
Publisher: Springer Science and Business Media LLC
Date: 22-07-2019
Publisher: Wiley
Date: 06-11-2019
DOI: 10.1002/PON.5257
Abstract: Morbidity from head and neck cancers (HNCs) and their treatment are significant, given their proximity to anatomical sites impacting facial appearance and function. Assessing the needs of HNC patients throughout their cancer journey is critical to informing quality care and improving quality of life. We aimed to identify available unmet needs measures in the HNC setting and appraise their content and psychometric properties. We conducted a systematic search of five electronic databases (July 2007-July 2019) to identify studies of unmet needs in patients with HNC. In addition, three web-based patient-reported outcome measures (PROMs) databases were searched for unmet needs measures. Citations were screened for eligibility and identified measures reviewed for content coverage and psychometric properties. From identified measures and literature, a conceptual framework with 12 clinically relevant aspects of unmet needs was developed and used to assess the conceptual coverage of available unmet needs measures. Literature search identified 273 records of which 28 studies assessing unmet needs in HNC cancer met eligibility criteria. Seven unmet needs measures were identified from retrieved studies and seven additional measures from PROM databases. Thus, 14 measures in total were reviewed. Content mapping revealed that three measures demonstrated excellent content validity (greater than 80% conceptual coverage): Patient Concerns Inventory (PCI), Needs Assessment for Advanced Cancer Patients (NA-ACP), and James Supportive Care Screening (JSCS). We recommend PCI be used to measure unmet needs in the HNC setting considering the importance of content validity over quantitative psychometric properties.
Publisher: Springer Science and Business Media LLC
Date: 23-04-2020
DOI: 10.1186/S41687-020-00189-7
Abstract: A cancer diagnosis is potentially life-threatening, likely causing distress and uncertainty, which may be psychologically debilitating. Depression and anxiety are commonly underdiagnosed and undertreated in cancer patients. Head and neck cancer (HNC) patients face particular challenges that may contribute to distress. This review aims to: i) identify patient reported outcome measures (PROMs) designed to assess anxiety and depression in HNC and ii) determine their suitability for use in research and clinical practice to screen patients. We searched five electronic databases between July 2007 to July 2019 for studies assessing anxiety and depression in HNC patients. Searches were limited to this period to account for advances in cancer treatment. Records were screened for eligibility by one reviewer and 10% cross-checked by a second across all stages of the review. In addition to the electronic searches, PROM databases were searched for additional measures of anxiety and depression. All retrieved PROMs were mapped against Diagnostic and Statistical Manual-5 criteria for anxiety and depression to assess content coverage. Then, their psychometric properties appraised against the COSMIN checklist. Electronic searches identified 98 records, from which five anxiety and eight depression measures were retrieved. PROM database searches retrieved an additional four anxiety and four depression measures a total of nine anxiety and 12 depression measures were appraised. Content coverage of anxiety measures ranged from 50% to 75% and depression measures from 42% to 100%. Demonstration of psychometric properties against COSMIN criteria ranged from 57% to 71% for anxiety measures (three PROMs 70%) and from 29% to 86% for depression measures (nine PROMs 70%). Three anxiety and seven depression measures had established clinical cut-offs in cancer populations. The Patient Health Questionnaire-9, Zung Self-rating Depression and Zung Self-rating Anxiety Scales demonstrated good content coverage along with excellent psychometric properties, and thus were considered the most suitable PROMs to assess psychological distress in HNC populations. It is important to have PROMs assessing psychological distress that capture a comprehensive set of subjective symptoms. The identified PROMs will help researchers and health professionals in clinical-decision making, thereby potentially improving quality of life in HNC patients.
Publisher: Elsevier BV
Date: 05-2023
Publisher: JMIR Publications Inc.
Date: 12-08-2019
DOI: 10.2196/13701
Abstract: Pressure ulcers represent a major challenge to patient safety in the health care context, presenting high incidence (from 7% to 14% in Spain) and increased financial costs (€400-600 million/year) in medical treatment. Moreover, they are a significant predictor of mortality. The prevention of pressure ulcers in long-term care centers and patients’ own homes is proposed as a priority indicator of health care quality. Early stage risk assessment and database recording are both crucial aspects of prevention, classification, diagnosis, and treatment. This project proposes a 3-year study of immobilized patients residing in the Granada-Metropolitan Primary Healthcare District (DSGM) and monitored via the Pressure Ulcer Information and Registration System (SIRUPP, Spanish initials). The project aims to estimate the incidence of PUs among immobilized elderly patients, analyze the health-related quality of life of these patients by using the Pressure Ulcer Quality of Life (PU-QoL) instrument in a s le of 250 patients, determine the average time to complete wound healing, estimate the rate of pressure ulcers–associated mortality, and assess the predictive value of the Braden and Mini Nutritional Assessment risk measurement scales in a s le of 1700 patients. The DSGM runs SIRUPP, which is linked to patients’ electronic health records. Currently, 17,104 immobilized patients are monitored under this system. Health-related quality of life will be measured by patient self-reports using the Spanish Pressure Ulcer Quality of Life questionnaire, following cross-cultural adaptation and psychometric validation with respect to the English-language version. The project commenced in June 2017 and is expected to conclude in April 2020. This study addresses two main health outcomes—the time needed for wound healing and the mortality associated with pressure ulcers—both of which might be accounted for by variations in clinical practice and the health-related quality of life of patients with pressure ulcers. DERR1-10.2196/13701
Publisher: Springer Science and Business Media LLC
Date: 16-04-2013
DOI: 10.1038/SC.2013.29
Abstract: A systematic review was undertaken, based upon methods recommended for effectiveness questions but adapted to identify observational risk factor (RF) studies. The literature identifies many RFs for pressure ulcer (PU) recurrence and development however, RFs independently predictive of PU development in adults with spinal cord injury (SCI) have not been determined. A systematic review was undertaken to identify RFs for PUs for people with SCI. Acute hospital, community and rehabilitation settings. Electronic searches of MEDLINE, EMbase and Cochrane databases from 1980 to 2011 were completed. Retrieved studies were assessed for eligibility and quality criteria applied by two independent reviewers. Identified RFs were categorised into themes and compared and contrasted with RFs identified for the general PU population. The five studies included 18 RFs. These were classified into six themes: sociodemographic, neurological, functional, clinical, biological and medical care management. RFs for both the general and SCI-specific populations were similar, however, clinical, functional and hospital management emerged as specific RF domains for the SCI population. We identified SCI-specific RFs for the development and recurrence of PUs. However, these findings are based on a small number of studies highlighting the need for further confirmatory work to reduce PU development and recurrence, and provide a foundation for SCI risk assessment development.
Publisher: Springer Science and Business Media LLC
Date: 07-06-2021
DOI: 10.1186/S41687-021-00316-Y
Abstract: Head and neck cancers (HNC) are one of the most traumatic forms of cancer because they affect essential aspects of life such as speech, swallowing, eating and disfigurement. HNCs are common in India, with over 100,000 cases being registered each year. HNC and treatment are both associated with considerable anxiety and depression. With increasing multinational research, no suitable measures in Indian languages are available to assess anxiety and depression in Indian HNC patients. This study evaluated the psychometric properties of cross-culturally adapted versions of Zung’s self-rating Anxiety Scale (SAS) and the Patient health questionnaire – 9 (PHQ-9) in Tamil, Telugu and Hindi speaking Indian HNC populations. HNC patients were recruited from three tertiary cancer centres in India. Patients completed the cross-culturally adapted versions of SAS and PHQ-9. We assessed targeting, scaling assumptions, construct validity (exploratory and confirmatory factor analyses), convergent validity, and internal consistency reliability. The study s le included 205 Tamil, 216 Telugu and 200 Hindi speaking HNC patients. Exploratory and confirmatory factor analyses indicated a two-factor solution for PHQ-9 and four-factor solution for SAS in all three languages. Cronbach’s alpha coefficients ranged between 0.717 and 0.890 for PHQ-9 and between 0.803 and 0.868 for SAS, indicating good reliability. Correlations between hypothesized scales were as expected providing evidence towards convergent validity. This first psychometric evaluation of the measurement properties of Tamil, Telugu and Hindi versions of the SAS and PHQ-9 in large, Indian HNC populations supported their use as severity and outcome measures across the disease and treatment continuum.
Publisher: Springer Science and Business Media LLC
Date: 12-02-2014
Publisher: Elsevier BV
Date: 12-2010
DOI: 10.1016/J.IJNURSTU.2010.05.014
Abstract: Evaluating outcomes such as health-related quality of life is particularly important and relevant in skin conditions such as pressure ulcers where the condition and associated interventions pose substantial burden to patients. Measures to evaluate such outcomes need to be developed by utilising patient-perspective to ensure that content and conceptualisation is relevant to patients. Our aim was to develop a conceptual framework of health-related quality of life in pressure ulcers, based on patients' views about the impact of pressure ulcers and interventions on health-related quality of life to inform the development of a new patient-reported outcome measure. SETTING, PARTICIPANTS AND METHODS: We developed a working conceptual framework based on a previous review of the literature, then used semi-structured qualitative interviews with 30 adults with pressure ulcers (22-94 years) purposively s led from hospital, community and rehabilitation care settings in England and Northern Ireland to obtain patients' views, and thematic content analysis and review by a multidisciplinary expert group to develop the final conceptual framework. Our conceptual model includes four health-related quality of life domains (symptoms, physical functioning, psychological well-being, social functioning), ided into 13 sub-domains and defined by specific descriptive components. We have identified health-related quality of life outcomes that are important to people with pressure ulcers and developed a conceptual framework using robust and systematic methods, which provides the basis for the development of a new pressure ulcer-specific measure of health-related quality of life.
Publisher: Elsevier BV
Date: 11-2011
DOI: 10.1016/J.IJNURSTU.2011.05.010
Abstract: The overall prevalence of foot ulceration occurring in patients with rheumatoid arthritis is estimated at 10-13% in the UK, with a high rate of recurrence. In contrast with diabetes, there has been a lack of research in this area and the impact of the problem from a patient perspective is poorly understood. To explore the added impact of foot ulceration on health-related quality of life in non-diabetic patients with rheumatoid arthritis. Qualitative research design to elicit patient experiences. Participants were recruited from hospital and community podiatry clinics in West Yorkshire (UK) between May 2008 and June 2009. A purposive s le of 23 adults with RA and open foot ulceration patients with diabetes were excluded. In-depth interviews were conducted with 23 participants using a topic guide. Framework analysis was employed to facilitate a case and theme based approach to identifying descriptive and explanatory accounts of the impact of foot ulceration on health-related quality of life. Participants indicated that foot ulceration impacted on their health-related quality of life across physical, social and psychological domains. Pain attributed to the ulcer was linked to new walking disability, affecting participants' lives in every domain. Pain and walking disability added to existing limitations in undertaking household tasks and personal care independently. Keeping the ulcer dry was a major problem for many in relation to personal hygiene. Participants described new restrictions in leisure activities which reduced social participation. Increased footwear/clothing restrictions affected self esteem and altered body image. An economic cost was attached to wound care and footwear alterations. Low mood, anxiety, frustration were attributed to the added impact of foot ulceration on their lives. Perceptions of impact fluctuated over time in relation to physical symptoms experienced by participants and the additional social limitations posed by the ulcer. Foot ulceration has an additional impact on health-related quality of life over and above the impact of rheumatoid arthritis in every domain. Whilst prevention is the ultimate goal, high rates of recurrence mean that clinicians need to consider ways to improve quality of life for affected patients throughout the patient journey.
Publisher: National Institute for Health and Care Research
Date: 09-2019
DOI: 10.3310/HTA23520
Abstract: Pressure ulcers (PUs) are a burden to patients, carers and health-care providers. Specialist mattresses minimise the intensity and duration of pressure on vulnerable skin sites in at-risk patients. Time to developing a new PU of category ≥ 2 in patients using an alternating pressure mattress (APM) compared with a high-specification foam mattress (HSFM). A multicentre, Phase III, open, prospective, planned as an adaptive double-triangular group sequential, parallel-group, randomised controlled trial with an a priori s le size of 2954 participants. Randomisation used minimisation (incorporating a random element). The trial was set in 42 secondary and community inpatient facilities in the UK. Adult inpatients with evidence of acute illness and at a high risk of PU development. APM or HSFM – the treatment phase lasted a maximum of 60 days the final 30 days were post-treatment follow-up. Time to event. From August 2013 to November 2016, 2029 participants were randomised to receive either APM ( n = 1016) or HSFM ( n = 1013). Primary end point – 30-day final follow-up: of the 2029 participants in the intention-to-treat population, 160 (7.9%) developed a new PU of category ≥ 2. There was insufficient evidence of a difference between groups for time to new PU of category ≥ 2 [Fine and Gray model HR 0.76, 95% confidence interval (CI) 0.56 to 1.04 exact p -value of 0.0890 and 2% absolute difference]. Treatment phase sensitivity analysis: 132 (6.5%) participants developed a new PU of category ≥ 2 between randomisation and end of treatment phase. There was a statistically significant difference in the treatment phase time-to-event sensitivity analysis (Fine and Gray model HR 0.66, 95% CI 0.46 to 0.93 p = 0.0176 and 2.6% absolute difference). Secondary end points – 30-day final follow-up: new PUs of category ≥ 1 developed in 350 (17.2%) participants, with no evidence of a difference between mattress groups in time to PU development, (Fine and Gray model HR 0.83, 95% CI 0.67 to 1.02 p -value = 0.0733 and absolute difference 3.1%). New PUs of category ≥ 3 developed in 32 (1.6%) participants with insufficient evidence of a difference between mattress groups in time to PU development (Fine and Gray model HR 0.81, 95% CI 0.40 to 1.62 p = 0.5530 and absolute difference 0.4%). Of the 145 pre-existing PUs of category 2, 89 (61.4%) healed – there was insufficient evidence of a difference in time to healing (Fine and Gray model HR 1.12, 95% CI 0.74 to 1.68 p = 0.6122 and absolute difference 2.9%). Health economics – the within-trial and long-term analysis showed APM to be cost-effective compared with HSFM however, the difference in costs models are small and the quality-adjusted life-year gains are very small. There were no safety concerns. Blinded photography substudy – the reliability of central blinded review compared with clinical assessment for PUs of category ≥ 2 was ‘very good’ (kappa statistic 0.82, prevalence- and bias-adjusted kappa 0.82). Quality-of-life substudy – the Pressure Ulcer Quality of Life – Prevention (PU-QoL-P) instrument meets the established criteria for reliability, construct validity and responsiveness. A lower than anticipated event rate. In acutely ill inpatients who are bedfast/chairfast and/or have a category 1 PU and/or localised skin pain, APMs confer a small treatment phase benefit that is diminished over time. Overall, the APM patient compliance, very low PU incidence rate observed and small differences between mattresses indicate the need for improved indicators for targeting of APMs and in idualised decision-making. Decisions should take into account skin status, patient preferences (movement ability and rehabilitation needs) and the presence of factors that may be potentially modifiable through APM allocation, including being completely immobile, having nutritional deficits, lacking capacity and/or having altered skin/category 1 PU. Explore the relationship between mental capacity, levels of independent movement, repositioning and PU development. Explore ‘what works for whom and in what circumstances’. Current Controlled Trials ISRCTN01151335. This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 23, No. 52. See the NIHR Journals Library website for further project information.
Publisher: Informa UK Limited
Date: 04-2016
DOI: 10.1111/AP.12165
Publisher: Springer Science and Business Media LLC
Date: 27-04-2017
DOI: 10.1007/S00520-017-3717-5
Abstract: Non-muscle invasive bladder cancer (NMIBC) is a chronic condition requiring repeated treatment and endoscopic examinations that can be life-long. In this context, health-related quality of life (HRQOL) is important to patients and managing clinicians, and integral to treatment recommendations for NMIBC. The aim of this study was to develop a conceptual framework of patient-reported NMIBC symptoms, treatment side effects, and HRQOL impacts from three sources: (1) literature, (2) patients and (3) treating clinicians. First, we undertook a scoping literature review for studies reporting patient-reported outcomes associated with NMIBC. Outcomes were extracted and grouped conceptually. Then, we conducted semi-structured interviews with patients with NMIBC and treating clinicians. Patients were asked about symptoms and HRQOL impacts experienced from their NMIBC and treatments. Clinicians were asked about commonly reported outcomes, and outcomes they felt were important to assess clinically. Interviews were audio recorded, transcribed and content analysed. A total of 125 symptom- and functioning-related expressions from 18 studies, 26 patients and 20 clinicians were coded into three themes and 18 sub-themes. Patients commonly reported blood in urine and frequent urination. Clinicians considered BCG sepsis and flu-like symptoms important outcomes to assess during treatment for NMIBC. Our empirically derived conceptual framework identifies patient-reported outcomes that are important to people with NMIBC, provides the basis for the development of a new NMIBC-specific symptom index, and guides the design of a comprehensive PRO assessment plan for clinical practice in NMIBC and future clinical trials of treatments for NMIBC.
Publisher: Springer Science and Business Media LLC
Date: 03-09-2016
DOI: 10.1007/S11136-015-1110-8
Abstract: Technological advances in recent decades have led to the availability of new modes to administer patient-reported outcomes (PROs). To aid selecting optimal modes of administration (MOA), we undertook a systematic review to determine whether differences in bias (both size and direction) exist among modes. We searched five electronic databases from 2004 (date of last comprehensive review on this topic) to April 2014, cross-referenced and searched reference lists. Studies that compared two or more MOA for a health-related PRO measure in adult s les were included. Two reviewers independently applied inclusion and quality criteria and extracted findings. Meta-analyses and meta-regressions were conducted using random-effects models. Of 5100 papers screened, 222 were considered potentially relevant and 56 met eligibility criteria. No evidence of bias was found for: (1) paper versus electronic self-complete and (2) self-complete versus assisted MOA. Heterogeneity for paper versus electronic comparison was explained by type of construct (i.e. physical vs. psychological). Heterogeneity for self-completion versus assisted modes was in part explained by setting (clinic vs. home) the largest bias was introduced when assisted completion occurred in the clinic and follow-up was by self-completion (either electronic or paper) in the home. Self-complete paper and electronic MOA can be used interchangeably for research in clinic and home settings. Self-completion and assisted completion produce equivalent scores overall, although heterogeneity may be induced by setting. These results support the use of mixed MOAs within a research study, which may be a useful strategy for reducing missing PRO data.
Publisher: Elsevier BV
Date: 2014
DOI: 10.1016/J.IJNURSTU.2013.03.004
Abstract: Pressure ulcers are a major health problem, affect patient psychological, physical and social functioning, and cause significant treatment burden. For comprehensive assessment of the benefits of an intervention, patient-reported evidence of the impact of an intervention on important patient outcomes should be made. We systematically reviewed the quality of life literature on chronic wounds to determine the suitability of generic and chronic wound-specific outcome measures for use in evaluating patient outcomes in pressure ulcer research. A systematic review of the literature. Searches of eight electronic databases from inception until May 2012 were undertaken. Quality of life domains, item content and content relevance were determined for identified outcome measures. The content validity of identified measures was assessed against an empirically derived pressure ulcer-specific conceptual framework. Three generic and 14 chronic wound measures were identified but no pressure ulcer-specific measures. None of the existing measures cover all quality of life domains important in pressure ulcers. One condition-specific measure, the Venous Leg Ulcer Measure, matched most closely conceptually, but failed to represent three important domains and contained items not specific to pressure ulcers. Currently, outcomes important in pressure ulcers are inadequately covered by generic and chronic wound-specific instruments despite similar conceptual models. Highlighted is the need for clear conceptualisation of content as well as determining appropriateness when selecting outcome measures in the future.
Publisher: Springer Science and Business Media LLC
Date: 20-01-2021
Publisher: ASME International
Date: 31-01-2011
DOI: 10.1115/1.4003325
Abstract: Sitting-acquired deep tissue injury (DTI) is a severe form of pressure ulcer (PU) often affecting patients with spinal cord injury (SCI) who also tend to suffer from intramuscular fat infiltration, soft tissue scarring (due to previous PU), and/or muscle spasticity in their buttocks. We previously used finite element (FE) modeling to evaluate whether abnormal bodyweight is a risk factor for sitting-acquired DTI. Here we hypothesize that fat infiltration, scarring, or spasms increase internal loads in the gluteus muscles in the vicinity of the ischial tuberosities during sitting, which consequently put SCI patients with these conditions at a higher risk for DTI. Our objective was to determine changes in gluteal strains and stresses and tissue volumes exposed to elevated strains/stresses associated with these factors. Thirty-five FE models of coronal slices through the seated buttocks, simulating these conditions at different severities, were developed. We calculated peak strains and stresses in glutei and percentage volumes of muscle tissue exposed to above-critical strains/stresses (compression strain≥50%, compression/von Mises stress≥2 kPa, and strain energy density≥0.5 kPa). Progressive intramuscular fat infiltration increased all the aforementioned outcome measures. Increase in size of scar patterns that were contained in both muscle and fat tissues similarly elevated the outcome measures. Spasms increased muscle stresses and volumetric exposures to stress, but tissue volumes at risk were ∼1–2% and increases due to spasticity were slight. We conclude that the above potential risk factors can be listed according to the following order of importance: (i) fat infiltration, (ii) scars contained in both muscle and fat tissues, and (iii) spasms. This information should be considered when prioritizing prevention means and resources for patients with SCI.
Publisher: Springer Science and Business Media LLC
Date: 02-04-2021
Publisher: Springer Science and Business Media LLC
Date: 14-02-2020
Publisher: JMIR Publications Inc.
Date: 15-02-2019
Abstract: ressure ulcers represent a major challenge to patient safety in the health care context, presenting high incidence (from 7% to 14% in Spain) and increased financial costs (€400-600 million/year) in medical treatment. Moreover, they are a significant predictor of mortality. The prevention of pressure ulcers in long-term care centers and patients’ own homes is proposed as a priority indicator of health care quality. Early stage risk assessment and database recording are both crucial aspects of prevention, classification, diagnosis, and treatment. his project proposes a 3-year study of immobilized patients residing in the Granada-Metropolitan Primary Healthcare District (DSGM) and monitored via the Pressure Ulcer Information and Registration System (SIRUPP, Spanish initials). The project aims to estimate the incidence of PUs among immobilized elderly patients, analyze the health-related quality of life of these patients by using the Pressure Ulcer Quality of Life (PU-QoL) instrument in a s le of 250 patients, determine the average time to complete wound healing, estimate the rate of pressure ulcers–associated mortality, and assess the predictive value of the Braden and Mini Nutritional Assessment risk measurement scales in a s le of 1700 patients. he DSGM runs SIRUPP, which is linked to patients’ electronic health records. Currently, 17,104 immobilized patients are monitored under this system. Health-related quality of life will be measured by patient self-reports using the Spanish Pressure Ulcer Quality of Life questionnaire, following cross-cultural adaptation and psychometric validation with respect to the English-language version. he project commenced in June 2017 and is expected to conclude in April 2020. his study addresses two main health outcomes—the time needed for wound healing and the mortality associated with pressure ulcers—both of which might be accounted for by variations in clinical practice and the health-related quality of life of patients with pressure ulcers. ERR1-10.2196/13701
Publisher: Wiley
Date: 11-01-2018
DOI: 10.1002/PON.4596
Abstract: Testicular cancer (TC) affects young men and may cause psychological distress despite a good prognosis. This systematic review evaluated the prevalence, severity, and correlates of anxiety, depression, fear of cancer recurrence (FCR), and distress in TC survivors. A systematic search of literature published 1977 to 2017 was conducted to find quantitative studies including TC survivor-reported outcomes relevant to review objectives. The quality of included articles was assessed, and a narrative synthesis conducted. Of 6717 articles identified, 66 (39 good, 20 fair, and 7 poor quality) reporting results from 36 studies were included. Testicular cancer survivors' mean anxiety levels were higher than in the general population, while mean depression and distress were no different. Clinically significant anxiety (≈1 in 5) and to a lesser extent distress (≈1 in 7), but not depression, were more prevalent in TC survivors than the general population. Approximately 1 in 3 TC survivors experienced elevated FCR. Poorer psychological outcomes were more common among TC survivors who were single, unemployed/low socio-economic status, suffering from co-morbidities, experiencing worse symptoms/side effects, and using passive coping strategies. Many TC survivors do not experience significant psychological morbidity, but anxiety and FCR are prevalent. Inadequate coping resources (eg, low socio-economic status and social support) and strategies (eg, avoidance) and greater symptoms/side effects were associated with poorer outcomes. Theoretically driven prospective studies would aid understanding of how outcomes change over time and how to screen for risk. Age and gender appropriate interventions that prevent and manage issues specific to TC survivors are also needed.
Publisher: Springer Science and Business Media LLC
Date: 22-09-2021
Publisher: Elsevier BV
Date: 2010
DOI: 10.1016/J.JBIOMECH.2009.08.021
Abstract: Deep tissue injury (DTI) is a severe pressure ulcer characteristic of chairfast or bedfast in iduals, such as those with impaired mobility or neurological disorders. A DTI differs from superficial pressure ulcers in that the onset of DTI occurs under intact skin, in skeletal muscle tissue overlying bony prominences, and progression of the wound continues subcutaneously until skin breakdown. Due to the nature of this silently progressing wound, it is highly important to screen potentially susceptible in iduals for their risk of developing a DTI. Abnormally low and high values of the body mass index (BMI) have been proposed to be associated with pressure ulcers, but a clear mechanism is lacking. We hypothesize that during sitting, exposure to internal muscle tissue loads under the ischial tuberosities (IT) is elevated at abnormally high or low body mass indices. Our aims in this study were: (a) to develop biomechanical models of the IT region in the buttocks that represent an in idual who is gaining or losing weight drastically. (b) To determine changes in internal tissue load measures: principal compression strain, strain energy density (SED), principal compression stress and von Mises stress versus the BMI. (c) To determine percentage volumes of muscle tissue exposed to critical levels of the above load measures, which were defined based on our previous animal and tissue engineered model experiments: strain>or=50%, stress>or=2 kPa, SED>or=0.5 kPa. A set of 21 finite element models, which represented the same in idual, but with different BMI values within the normal range, above it and below it, was solved for the outcome measures listed above. The models had the same IT shape, size, distance between the IT, and (non-linear) mechanical properties for all soft tissues, but different thicknesses of gluteus muscles and fat tissue layers, corresponding to the BMI level. The resulted data indicated a trend of progressive increase in internal tissue loading, particularly in volumetric exposure to critical loading for BMI values outside the 17<or=BMI<or=22 kg/m(2) range, supporting our hypothesis for this study. We concluded that exposure to internal muscle tissue loads under the IT during sitting is optimally reduced at the low-normal BMI range, which is important not only in the context of DTI research, but also for understanding general sitting biomechanics.
Publisher: Springer Science and Business Media LLC
Date: 02-2018
DOI: 10.1007/S00520-018-4058-8
Abstract: Non-muscle invasive bladder cancer (NMIBC) is a chronic condition requiring ongoing treatment and endoscopic examinations that are frequent and can be life-long. To ensure the comprehensive assessment of the benefits and harms of treatments for NMIBC, the impact on important and relevant patient-reported outcomes (PROs) should be determined. We systematically reviewed the NMIBC PRO literature to determine the suitability of available PRO measures (PROMs) for use in evaluating patient outcomes in NMIBC research. We searched six electronic databases, reference lists, and key authors. Two reviewers independently applied inclusion and quality criteria and extracted findings. PROM domains, item content, and content coverage and relevance were determined for identified PROMs. Content validity was assessed against an empirically derived NMIBC-specific conceptual framework that includes 11 PRO domains and 19 sub-domains. Seventeen studies assessed PROs related to NMIBC and treatment impact. From these studies, 11 PROMs were identified, including three generic, three cancer-specific, and five symptom-specific. None of the PROMs cover all PRO domains important in NMIBC as assessed against our conceptual framework. The EORTC QLQ-C30 plus the NMIBC24 module was best aligned to the conceptual model, but failed to represent six outcomes important to NMIBC patients. Currently, some outcomes important in NMIBC are inadequately covered by generic and cancer-specific measures despite similar conceptual models. This review identified gaps in the literature regarding assessment of symptoms and other PROs considered important by NMIBC patients. Careful consideration of PROM item content is required when selecting outcome measures for use in future NMIBC clinical trials to ensure that appropriate measures are used to assess outcomes that matter to patients.
Publisher: Elsevier BV
Date: 07-2013
DOI: 10.1016/J.IJNURSTU.2012.11.019
Abstract: To identify risk factors independently predictive of pressure ulcer development in adult patient populations? A systematic review of primary research was undertaken, based upon methods recommended for effectiveness questions but adapted to identify observational risk factor studies. Fourteen electronic databases were searched, each from inception until March 2010, with hand searching of specialist journals and conference proceedings contact with experts and a citation search. There was no language restriction. Abstracts were screened, reviewed against the eligibility criteria, data extracted and quality appraised by at least one reviewer and checked by a second. Where necessary, statistical review was undertaken. We developed an assessment framework and quality classification based upon guidelines for assessing quality and methodological considerations in the analysis, meta-analysis and publication of observational studies. Studies were classified as high, moderate, low and very low quality. Risk factors were categorised into risk factor domains and sub-domains. Evidence tables were generated and a summary narrative synthesis by sub-domain and domain was undertaken. Of 5462 abstracts retrieved, 365 were identified as potentially eligible and 54 fulfilled the eligibility criteria. The 54 studies included 34,449 patients and acute and community patient populations. Seventeen studies were classified as high or moderate quality, whilst 37 studies (68.5%) had inadequate numbers of pressure ulcers and other methodological limitations. Risk factors emerging most frequently as independent predictors of pressure ulcer development included three primary domains of mobility/activity, perfusion (including diabetes) and skin ressure ulcer status. Skin moisture, age, haematological measures, nutrition and general health status are also important, but did not emerge as frequently as the three main domains. Body temperature and immunity may be important but require further confirmatory research. There is limited evidence that either race or gender is important. Overall there is no single factor which can explain pressure ulcer risk, rather a complex interplay of factors which increase the probability of pressure ulcer development. The review highlights the limitations of over-interpretation of results from in idual studies and the benefits of reviewing results from a number of studies to develop a more reliable overall assessment of factors which are important in affecting patient susceptibility.
Publisher: Springer Science and Business Media LLC
Date: 15-12-2019
DOI: 10.1007/S11136-018-2080-4
Abstract: A proxy is someone other than a patient who reports a patient's outcomes as if they are the patient. Due to known discordance with patient reports, proxies are often not recommended in clinical trials however, proxies may be needed in certain research contexts. We aimed to identify and describe trials registered on the Australian New Zealand Clinical Trials Registry (ANZCTR) with proxy-reported endpoints. ANZCTR was systematically searched from inception (2005) to 31 March 2017 for trials with proxy-reported endpoints. Primary and secondary endpoints for each trial retrieved by the search were in idually coded (proxy-reported: yes/no), and trials with confirmed proxy-reported endpoints were included in the analysis. Of 13,666 registered trials, 469 (3.4%) included a proxy-reported endpoint (867 in idual proxy-reported endpoints in total: 62% family member proxy, 22% health professional). Proxy endpoint inclusion did not significantly increase over time (r = 0.18, p = 0.59). Mental health (11.5%), stroke (10.3%) and neurological (8.3%) trials had the highest proportion of trials using proxies. Of the 469 trials, 123 (26.2%) studies involved paediatric patients. Proxy-reported endpoints are included in a small but notable number of studies, which may indicate other types of outcomes are used for patients unable to self-report, or that these patients are under-researched.
Publisher: JMIR Publications Inc.
Date: 26-07-2021
Abstract: vidence supports several countries introducing legislation to allow cannabis-based medicine as an adjunctive treatment for the symptomatic relief of chronic pain, chemotherapy-induced nausea, spasticity in multiple sclerosis (MS), epileptic seizures, depression, and anxiety. However, clinical trial participants do not represent the entire spectrum of disease and health status seen in patients currently accessing medicinal cannabis in practice. his study aims to collect real-world data to evaluate health-related quality of life in patients prescribed medicinal cannabis oil and describe any differences over time, from before starting therapy to after 3 and 12 months of therapy. dult patients newly prescribed medicinal cannabis oil by authorized prescribers and under the Special Access Schemes across Australia will be screened for eligibility and invited to participate. A s le size of 2142 is required, with a 3-month follow-up. All participants will complete the EuroQol 5-Dimension European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 Depression, Anxiety, and Stress Scale-21 Patients’ Global Impression of Change Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) version 1.0: Sleep Disturbance 8b and PROMIS SF Fatigue 13a questionnaires. Patients with chronic pain conditions will also complete the PROMIS SF version 1.0: Pain Intensity 3a and PROMIS SF version 1.0: Pain Interference 8a. Patients with movement disorders will also complete Quality of Life in Neurological Disorders (Neuro-QoL) SF version 1.0: Upper Extremity Function (Fine Motor and Activities of Daily Living) and if chorea is indicated, the Neuro-QoL SF version 2.0: Huntington’s Disease health-related Quality of LIFE-Chorea 6a. All questionnaires will be administered at baseline, 2 weeks (titration), monthly up to 3 months, and then every 2 months up to 1 year. ecruitment commenced in November 2020. By June 2021, 1095 patients were screened for the study by 69 physicians in centers across 6 Australian states: Australian Capital Territory, New South Wales, Queensland, South Australia, Victoria, and Western Australia. Of the patients screened, 833 (39% of the target s le size) provided consent and completed baseline questionnaires. Results are expected to be published in 2022. Results of this study will show whether patient-reported outcomes improve in patients accessing prescribed medicinal cannabis from baseline to 3 months and whether any changes are maintained over a 12-month period. This study will also identify differences in improvements in patient-reported outcomes among patients with different chronic conditions (eg, chronic pain, MS, epilepsy, Parkinson disease, or cancer). his protocol contains detailed methods that will be used across multiple sites in Australia. The findings from this study have the potential to be integral to treatment assessment and recommendations for patients with chronic pain and other health indicators for accessing medicinal cannabis. ustralian New Zealand Clinical Trials Registry: ANZCTRN12621000063819 www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380807& isReview=true ERR1-10.2196/32327
Publisher: Springer Science and Business Media LLC
Date: 30-07-2019
DOI: 10.1007/S11136-019-02255-0
Abstract: The prognostic value of patient-reported outcomes (PROs) has been determined in some cancers, but a focussed review in colorectal cancer (CRC) has not yet been conducted. We systematically reviewed PRO predictors of CRC patient survival. We searched four electronic databases (from inception to May 2018), reference lists and professional organisations to identify studies reporting pre-treatment PRO predictors of overall survival (OS) or progression-free survival (PFS) in CRC identified through univariate or multivariate models. Two reviewers independently applied inclusion criteria and extracted data on study characteristics, median and 1-year survival rates, PROs assessed and model results. In 25 of 27 studies (n = 12,544), at least one PRO was significantly associated with survival. Physical functioning, fatigue, pain and appetite loss predicted OS more often than other PROs in metastatic disease (19/27 studies). One study explored PRO predictors in early-stage CRC, finding emotional well-being and mood predicted OS. In mixed-stage s les (7/27 studies), physical functioning predicted OS more often than other PROs. Few studies modelled PFS, for which few PROs had predictive value. Physical and psychological functioning, pain, fatigue and appetite loss had prognostic significance above and beyond clinical predictors in CRC. Routine monitoring of these PROs may allow earlier detection and amelioration of problems, which may improve quality of life and perhaps extend survival. More research is needed to determine prognostic value of PROs in early-stage CRC, and prognostic significance of changes in PRO scores.
Publisher: Elsevier BV
Date: 08-2015
DOI: 10.1016/J.JTV.2015.05.003
Abstract: Multiple Sclerosis (MS) is a progressive, degenerative disease of the central nervous system. People with advanced disease who have compromised mobility, activity, sensory and/or cognitive abilities are at risk of pressure ulcers. Having a pressure ulcer has a substantial impact on a person's quality of life a generic pressure ulcer Health Related Quality of Life (HRQL) framework has been used in this study. To explore the views and opinions of patients with MS who have a pressure ulcer using a thematic framework and compare these to the general pressure ulcer population. Data for six MS patients was obtained through secondary analysis of transcripts from semi-structured interviews conducted during two studies which were part of a programme of HRQL Research. Patients with MS reported that their pressure ulcer affected their lives physically, psychologically and socially. All were confined to bed (as part of their pressure ulcer treatment) and therefore unable to participate in activities. Difficulties with movement and activity were partially attributed to the MS. Patients with MS did not report feeling ill with their pressure ulcer and expressed positive emotions and optimism. Pain or discomfort was a feature of the pressure ulcer for most patients. Pressure ulcers have a major impact on QOL for all patients. Problems with mobility and activity associated with the pressure ulcer were confounded by the MS.
Publisher: Elsevier BV
Date: 09-2011
DOI: 10.1016/J.JPAINSYMMAN.2010.11.016
Abstract: Pressure ulcers (PUs) can cause patients considerable pain and discomfort however, little is known about how PU pain affects patients' everyday lives. To improve outcomes for patients and to help clinicians manage PU pain, the existing qualitative and quantitative research bases were systematically reviewed. The aims were to identify and synthesize all research that obtained verbal patient reports of PU-associated pain, including descriptions of the pain experience, intensity, quality, and impact to interpret the complexities of the pain experienced from PUs describe specific characteristics of PU pain and determine how it affects patients' lives. We searched eight electronic databases (from inception to January 2010), hand searched and cross-referenced. Research studies that addressed the experience of PU-associated pain by direct patient reports were included. Two reviewers independently applied inclusion criteria and extracted findings, allocating findings to defined categories. Synthesis of findings and categories were reviewed by three reviewers until reaching consensus. Ten studies were included: six qualitative and four quantitative. These included 108 adults with PUs. The PU pain experience was mapped, producing a conceptual framework of five domains: communicating the pain, feeling the pain, impact of pain, self-management, and professional management, and represented by 23 subdomains and five mediating factors (four psychological well-being plus comorbidity). A biopsychosocial model of pain experienced from PUs is presented. Improved communication of pain experienced between the in idual and health care professionals is needed to promote more effective PU pain management in the future.
Publisher: Wiley
Date: 12-05-2016
DOI: 10.1002/EJP.894
Abstract: Few pain assessment scales have been used in pressure ulcer (PU) research and none developed or validated for people with PUs. We examined the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale to determine its utility as an outcome measure for people with pressure area-related pain. Leeds Assessment of Neuropathic Symptoms and Signs data from 728 participants underwent psychometric analyses: traditional tests for data quality, scaling assumptions, reliability and validity and a Rasch analysis including tests of fit, spread and targeting of item locations, response dependency, person separation index (reliability) and differential item functioning. Our findings offer support for a unidimensional scale confirmatory factor analysis indicated a non-significant chi-square test of model fit [(df = 14) 23.48, p = 0.053]. However, some misfit was identified at the overall scale and in idual item levels, and internal construct validity of the LANSS as an outcome measure for neuropathic pain in people with pressure area-related pain was not supported low to moderate item-total correlations [Chi Square (df = 28) 55.546, p = 0.002] and inter-item correlations (mean 0.117 and range from 0.063 to 0.415) and low Cronbach's alpha (0.549) and Person Separation Index (0.334). Requirements for reliable and valid measurement do not support the use of the LANSS as an outcome measure in people with PUs at the in idual level or as a generalized measurement scale of neuropathic pain across ulcer severity groups. Expanding the number of items to aid differentiation between neuropathic pain levels and improving scale reliability is recommended. WHAT DOES THIS STUDY ADD?: The Leeds Assessment of Neuropathic Symptoms and Signs scale (LANSS) is not suitable as an outcome measure of pressure ulcer-related neuropathic pain as it did not meet requirements for reliable and valid measurement in this population.
Publisher: Wiley
Date: 24-09-2023
Publisher: Springer Science and Business Media LLC
Date: 18-06-2018
DOI: 10.1007/S11136-018-1921-5
Abstract: It is important to understand the number, types and regions of trials that include patient-reported outcomes (PROs) to appreciate how patient experiences have been considered in studies of health and interventions. Twenty-seven percent of trials registered with ClinicalTrials.gov (2007-2013) included PROs however, a regional breakdown was not provided and no reviews have been conducted of the Australia New Zealand Clinical Trials Registry (ANZCTR). We aimed to identify trials registered with ANZCTR with PRO endpoints and describe their characteristics. ANZCTR was systematically searched from inception (2005) to 31 March 2017 for trials with PRO endpoints. Search terms included PRO measures listed in Patient-Reported Outcomes Quality of Life Instrument Database and Grid-Enabled Measures, as well as generic PRO terms (e.g. "quality of life" (QOL)). Trial endpoints were in idually coded using an established framework to identify trials with PROs for the analysis. Of 13,666 registered trials, 6168 (45.1%) included a PRO. The proportion of studies including PROs increased between 2006 and 2016 (r = 0.74, p = 0.009). Among the 6168 trials, there were 17,961 in idual PRO endpoints, including symptoms/functional outcomes/condition-specific QOL (65.6%), generic QOL (13.2%), patient-reported experiences (9.9%), patient-reported behaviours (7.9%). Mental health was the most common category (99.8% included PROs), followed by physical medicine/rehabilitation (65.6%), musculoskeletal (63.5%), public health (63.1%), and cancer (54.2%). Our findings suggest growing use of PROs in the assessment of health and interventions in ANZ. Our review identifies trial categories with limited patient-reported information and provides a basis for future work on the impact of PRO findings in clinical care.
Publisher: Springer Science and Business Media LLC
Date: 22-07-2019
Publisher: Elsevier BV
Date: 2017
DOI: 10.1016/J.EJCA.2016.09.035
Abstract: Ductal carcinoma in situ (DCIS) is a pre-invasive breast cancer with excellent prognosis but with potential adverse impacts of diagnosis and treatment on quality of life and other patient-reported outcomes (PROs). We undertook a systematic review to synthesise current evidence about PROs following diagnosis and treatment for DCIS. We searched five electronic databases (from database inception to November 2015), cross-referenced and contacted experts to identify studies that reported PROs after DCIS treatment. Two reviewers independently applied inclusion and quality criteria, and extracted findings. Of 2130 papers screened, 23 were eligible, reporting 17 studies. Short- and long-term PRO evidence about differences between DCIS treatment options was lacking. Evidence pooled across treatments indicated core aspects of quality of life (physical, role, social, emotional function, pain, fatigue) and psychological distress (anxiety, depression) were impacted significantly initially, with most aspects returning to population norms by 6-12 months, and all by 2 years post-operatively. Fears of recurrence and dying from breast cancer were exaggerated, occurred early and persisted for many years. Sexuality and body image impacts were generally low and resolved within 1-3 months after surgery. A minority of women experienced considerable impact, including depression and sexual issues associated with body image problems. Well-powered PRO studies are required to track recovery trajectories and long-term impacts of the range of contemporary and emerging local and systemic treatments for DCIS. PRO data would enable care providers to prepare patients for short-term sequelae and enable patients who have treatment options to exercise preferences in choosing among them.
Publisher: Springer Science and Business Media LLC
Date: 24-07-2011
DOI: 10.1007/S11136-011-9980-X
Abstract: Pretesting is key in the development of patient-reported outcome (PRO) instruments. We describe a mixed-methods approach based on interviews and Rasch measurement methods in the pretesting of the Pressure Ulcer Quality of Life (PU-QOL) instrument. We used cognitive interviews to pretest the PU-QOL in 35 patients with pressure ulcers with the view to identifying problematic items, followed by Rasch analysis to examine response options, appropriateness of the item series and biases due to question ordering (item fit). We then compared findings in an interactive and iterative process to identify potential strengths and weaknesses of PU-QOL items, and guide decision-making about further revisions to items and design/layout. Although cognitive interviews largely supported items, they highlighted problems with layout, response options and comprehension. Findings from the Rasch analysis identified problems with response options through reversed thresholds. The use of a mixed-methods approach in pretesting the PU-QOL instrument proved beneficial for identifying problems with scale layout, response options and framing/wording of items. Rasch measurement methods are a useful addition to standard qualitative pretesting for evaluating strengths and weaknesses of early stage PRO instruments.
Publisher: JMIR Publications Inc.
Date: 24-11-2021
DOI: 10.2196/32327
Abstract: Evidence supports several countries introducing legislation to allow cannabis-based medicine as an adjunctive treatment for the symptomatic relief of chronic pain, chemotherapy-induced nausea, spasticity in multiple sclerosis (MS), epileptic seizures, depression, and anxiety. However, clinical trial participants do not represent the entire spectrum of disease and health status seen in patients currently accessing medicinal cannabis in practice. This study aims to collect real-world data to evaluate health-related quality of life in patients prescribed medicinal cannabis oil and describe any differences over time, from before starting therapy to after 3 and 12 months of therapy. Adult patients newly prescribed medicinal cannabis oil by authorized prescribers and under the Special Access Schemes across Australia will be screened for eligibility and invited to participate. A s le size of 2142 is required, with a 3-month follow-up. All participants will complete the EuroQol 5-Dimension European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 Depression, Anxiety, and Stress Scale-21 Patients’ Global Impression of Change Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) version 1.0: Sleep Disturbance 8b and PROMIS SF Fatigue 13a questionnaires. Patients with chronic pain conditions will also complete the PROMIS SF version 1.0: Pain Intensity 3a and PROMIS SF version 1.0: Pain Interference 8a. Patients with movement disorders will also complete Quality of Life in Neurological Disorders (Neuro-QoL) SF version 1.0: Upper Extremity Function (Fine Motor and Activities of Daily Living) and if chorea is indicated, the Neuro-QoL SF version 2.0: Huntington’s Disease health-related Quality of LIFE-Chorea 6a. All questionnaires will be administered at baseline, 2 weeks (titration), monthly up to 3 months, and then every 2 months up to 1 year. Recruitment commenced in November 2020. By June 2021, 1095 patients were screened for the study by 69 physicians in centers across 6 Australian states: Australian Capital Territory, New South Wales, Queensland, South Australia, Victoria, and Western Australia. Of the patients screened, 833 (39% of the target s le size) provided consent and completed baseline questionnaires. Results are expected to be published in 2022. Results of this study will show whether patient-reported outcomes improve in patients accessing prescribed medicinal cannabis from baseline to 3 months and whether any changes are maintained over a 12-month period. This study will also identify differences in improvements in patient-reported outcomes among patients with different chronic conditions (eg, chronic pain, MS, epilepsy, Parkinson disease, or cancer). This protocol contains detailed methods that will be used across multiple sites in Australia. The findings from this study have the potential to be integral to treatment assessment and recommendations for patients with chronic pain and other health indicators for accessing medicinal cannabis. Australian New Zealand Clinical Trials Registry: ANZCTRN12621000063819 www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380807& isReview=true DERR1-10.2196/32327
Publisher: Wiley
Date: 03-2010
DOI: 10.1111/J.1365-2648.2009.05192.X
Abstract: This paper is a report of a study conducted to compare the effectiveness of qualitative methodology search strategies with subject-specific (health-related quality of life) search strategies in the retrieval of qualitative patient-reported data of the impact of pressure ulcers on health-related quality of life. Methods to locate qualitative patient-reported health-related quality of life research data electronically have undergone little replication and validation. A major problem in searching for this type of data is that it is reported in accounts of both primary qualitative research as well as mixed methods research. We combined five search strategies with terms for pressure ulcer and searched seven electronic databases from inception to October 2007. The sensitivity, specificity, precision and accuracy for each search strategy were assessed. A subject-specific (health-related quality of life) search strategy, developed by us, had a high yield (100% sensitivity), but low specificity (<50%). The research methodology-based strategies had lower yields (sensitivity 72-83%) but high specificity (79-83%). Importantly, subject-specific search strategies identified all studies reporting qualitative patient-reported health-related quality of life data, whereas, research methodology-based strategies did not identify qualitative data reported in mixed method studies, making subject-based strategies more effective in retrieving qualitative patient-reported health-related quality of life research. An important consideration in the health-related quality of life field is that qualitative data are reported in both qualitative and mixed methodology research and searching for this type data involves trade-offs between yield, sensitivity and specificity. Accurate indexing of subject-specific outcomes and methodology used in electronic databases and publications is also needed.
Publisher: Springer Science and Business Media LLC
Date: 28-02-2017
DOI: 10.1007/S12282-017-0765-0
Abstract: To explore quality-of-life (QOL) issues considered important when deciding on treatment for ductal carcinoma in situ (DCIS). Breast Cancer Network of Australia members diagnosed with DCIS in the past 5 years (self-identified) participated in an online survey (Sep-Nov 2015). From a list of 74 QOL issues, participants selected all issues they experienced during DCIS diagnosis, treatment or recovery, then the issues they felt important to making a DCIS treatment decision, and completed the Health Literacy Questionnaire (HLQ). Associations between QOL issues and self-reported treatment received were assessed with χ The primary analysis included 38 participants treated with breast-conserving surgery (n = 15), mastectomy (n = 23), and/or radiotherapy (n = 14). Fatigue-related symptoms (82%) and "fear of progression" (50%) were the most frequently-experienced issues. When deciding on DCIS treatment, the most important consideration was "fear of progression" (50%). A higher proportion of mastectomy (compared to non-mastectomy) patients considered "difficultly looking at yourself naked" (p = 0.03). Radiotherapy (compared to non-radiotherapy) patients were more likely to consider "feeling unwell" important (p = 0.006). Results were similar in a sensitivity analysis involving all 101 respondents (i.e., including 63 respondents who reported receiving chemotherapy, endocrine therapy, and/or Herceptin, suggesting that they may have been treated for invasive breast cancer). Health literacy was high across all nine HLQ scales. Fear of progression is a key consideration in DCIS treatment decision making for women with high health literacy. QOL treatment considerations differed by treatments received. Women diagnosed with DCIS may benefit from evidence about QOL to inform treatment decision making.
Publisher: Springer Science and Business Media LLC
Date: 12-2016
Publisher: Elsevier BV
Date: 02-2012
DOI: 10.1016/J.JTV.2011.11.001
Abstract: With the recognition of health-related quality of life (HRQL) as an important and relevant outcome in pressure ulceration, it is important to gain better understanding of the complex relationship among the various factors that affect it. A problem with existing literature in this area is that the impact of having a pressure ulcer on HRQL is combined conceptually with contributory factors which may influence outcome. This study identified contributory factors affecting pressure ulcer-related HRQL and explored interrelationships between factors based on views of adults with pressure ulcers. We obtained patient-reported qualitative data through semi-structured interviews with 30 patients with pressure ulcers recruited from hospital and community settings around England and Northern Ireland. Patients described how pressure ulcers affected their lives by recounting specific relevant events. Events (patient-reported issues) were sorted into categories and data framework analysed to produce a taxonomy of contributory factors. Inter-rater reliability established the extent of agreement between two independent raters. We identified 16 contributory factors, into two theme taxonomy: experience-of-care and in idual-patient factors, defined by descriptive components. Our taxonomy is a comprehensive theoretical model of factors that contribute to pressure ulcer-related HRQL. We have also identified further research priorities to inform clinical practice.
Publisher: Springer Science and Business Media LLC
Date: 02-12-2022
DOI: 10.1186/S41687-022-00524-0
Abstract: Patient-reported experience measures (PREMs) assess quality-of-care from patients’ perspectives. PREMs can be used to enhance patient-centered care and facilitate patient engagement in care. With increasing quality improvement studies in clinical practice, the use of PREMs has surged. As a result, knowledge about stakeholder experiences of using PREMs to assess quality of care across erse clinical settings is needed to inform PREM implementation efforts. To address this, this review examines the qualitative literature on patient and healthcare provider experiences of using PREMs in clinical practice. Medline, Embase and PsycInfo were systematically searched from inception to May 2021. Additional searching of reference lists for all included articles and relevant review articles were performed. Retrieved articles were screened for eligibility by one reviewer and 25% cross-checked by a second reviewer across all stages of the review. Full texts meeting eligibility criteria were appraised against the COREQ checklist for quality assessment and thematic analysis was used to analyze textual data extracted from the results. Electronic searches identified 2683 records, of which 20 studies met eligibility criteria. Extracted data were synthesized into six themes: facilitators to PREM implementation barriers to PREM implementation healthcare providers’ perspectives towards using PREMs patients’ perspectives towards using PREMs advantages of using PREMs in clinical practice limitations and practical considerations to reduce resistance of PREM usage. The primary factors facilitating and impeding the use of PREMs include organizational-, staff- and patient-related factors. Results can be used to guide the usage and implementation of PREMs in clinical settings by addressing the identified barriers and building on the perceived benefits to encourage adoption of PREMs. Results around facilitators to PREM implementation and practical considerations could also promote appropriate use of PREMs by healthcare providers, helping to improve practice and the quality of care based on patient feedback.
Publisher: Springer Science and Business Media LLC
Date: 15-06-2019
DOI: 10.1007/S00520-019-04919-6
Abstract: Head and neck cancer (HNC) is a relatively common cancer which causes a significant health burden, impacting in iduals physically and psychologically. HNC treatment may result in facial disfigurement, eating and communication difficulties, and body image disturbances. We aimed to (1) identify HNC-specific patient-reported outcome measures (PROMs) used to assess body image, (2) evaluate their conceptual coverage, (3) appraise their development process and psychometric properties, and (4) determine appropriate body image PROM(s) for use in the HNC setting. Online databases were searched (July 2007-July 2017) for studies that assessed body image in patients with HNC. Studies were screened for eligibility. In addition, we searched three PROM databases for relevant PROMs. From available body image frameworks, we compiled a conceptual schema consisting of 18 clinically relevant body image issues important in the HNC setting, against which PROMs were assessed. Selected measures were appraised for psychometric characteristics, content, and readability. A total of 245 records were retrieved. 18 studies with PROMs met our inclusion criteria, reporting eight PROMs. The PROM databases searched yielded 62 measures. After screening, eleven measures were short-listed and appraised. The Derriford Appearance Scale (DAS)-59, DAS-24, and body image scale (BIS) cover > 55% of issues within the body image conceptual schema were developed based on literature, patient interviews, and clinician opinions and have evidence of internal consistency (Cronbach alpha > 0.7), validity, and responsiveness. We recommend the DAS-24 and BIS as having adequate coverage of HNC-related issues, and suitable for use in future research.
Publisher: Wiley
Date: 30-03-2019
DOI: 10.1111/WRR.12716
Abstract: Patient-reported outcomes can be included as end points in pressure ulcer (PU) intervention trials to provide information to inform decision-making and improve the lives of patients. However, the challenge for researchers and clinicians is identifying and choosing an appropriate instrument for each particular application that suits their research questions and clinical context. To provide researchers and clinicians with the information needed to inform choice of patient-reported outcome measures, we compared a generic and disease-specific measures' ability to discriminate between clinical groups known to differ, and determined their responsiveness to change. We performed analyses on a subset of patients recruited to the PRESSURE 2 trial that completed the pressure ulcer quality of life instrument-prevention version (PU-QOL-P) and Short Form 12 Questionnaire (SF12) measures at baseline and 30-day posttreatment. Known-group validity and responsiveness-to-change analyses were conducted. The analysis s le consisted of 617 patients that completed both measures at baseline. Known-group validity revealed that some PU-QOL-P symptoms and function scales differentiated between people with category 2 PUs and those without PUs. A less meaningful pattern of results was observed for the SF12 scales, suggesting that the PU-QOL-P is more sensitive to differences between PU and non-PU populations. Responsiveness analysis revealed that the PU-QOL-P was more responsive in detecting disease severity than the SF12. The PU-QOL-P provides a standardized method for assessing PU-specific symptoms and functioning outcomes and is suitable for quantifying the benefits of PU interventions from the patient's perspective. Generic measures are useful for group comparisons of global quality of life domains. Choice of measure for each particular application should be determined by the purpose of the measurement and the information required.
Publisher: The Journal of Rheumatology
Date: 15-05-2019
Abstract: Flare in knee and hip osteoarthritis (OA) is more than just an exacerbation of pain. Unstructured, semistructured, and focus group interviews followed by Delphi surveys with patients and health professionals (HP) generated candidate domains of an OA flare. Content analysis of interviews with 29 patients and 16 HP extracted 180 statements, which were grouped into 9 clusters. Delphi consensus with 50 patients (Australia, Canada, and France) and 116 HP (17 countries on 4 continents) identified 5 flare domains: pain, swelling, stiffness, psychological aspects, and effect of symptoms. Elements for a preliminary definition of an OA flare are proposed. Registered at clinicaltrials.gov NCT02892058 .
Publisher: Oxford University Press (OUP)
Date: 08-11-2017
DOI: 10.1002/BJS.10656
Abstract: The aim was to carry out phase 4 international field-testing of the European Organisation for Research and Treatment of Cancer (EORTC) breast reconstruction (BRECON) module. The primary objective was finalization of its scale structure. Secondary objectives were evaluation of its reliability, validity, responsiveness, acceptability and interpretability in patients with breast cancer undergoing mastectomy and reconstruction. The EORTC module development guidelines were followed. Patients were recruited from 28 centres in seven countries. A prospective cohort completed the QLQ-BRECON15 before mastectomy and the QLQ-BRECON24 at 4–8 months after reconstruction. The cross-sectional cohort completed the QLQ-BRECON24 at 1–5 years after reconstruction, and repeated this 2–8 weeks later (test–retest reliability). All participants completed debriefing questionnaires. A total of 438 patients were recruited, 234 in the prospective cohort and 204 in the cross-sectional cohort. A total of 414 reconstructions were immediate, with a comparable number of implants (176) and donor-site flaps (166). Control groups comprised patients who underwent two-stage implant procedures (72, 75 per cent) or delayed reconstruction (24, 25 per cent). Psychometric scale validity was supported by moderate to high item-own scale and item-total correlations (over 0·5). Questionnaire validity was confirmed by good scale-to-s le targeting, and computable scale scores exceeding 50 per cent, except nipple cosmesis (over 40 per cent). In known-group comparisons, QLQ-BRECON24 scales and items differentiated between patient groups defined by clinical criteria, such as type and timing of reconstruction, postmastectomy radiotherapy and surgical complications, with moderate effect sizes. Prospectively, sexuality and surgical side-effects scales showed significant responsiveness over time (P & 0·001). Scale reliability was supported by high Cronbach's α coefficients (over 0·7) and test–retest (intraclass correlation more than 0·8). One item (finding a well fitting bra) was excluded based on high floor/ceiling effects, poor test–retest and weak correlations in factor analysis (below 0·3), thus generating the QLQ-BRECON23 questionnaire. The QLQ-BRECON23 is an internationally validated tool to be used alongside the EORTC QLQ-C30 (cancer) and QLQ-BR23 (breast cancer) questionnaires for evaluating quality of life and satisfaction after breast reconstruction.
Publisher: Springer Science and Business Media LLC
Date: 2013
Publisher: National Institute for Health and Care Research
Date: 09-2019
DOI: 10.3310/HTA23520
Abstract: Pressure ulcers (PUs) are a burden to patients, carers and health-care providers. Specialist mattresses minimise the intensity and duration of pressure on vulnerable skin sites in at-risk patients. Time to developing a new PU of category ≥ 2 in patients using an alternating pressure mattress (APM) compared with a high-specification foam mattress (HSFM). A multicentre, Phase III, open, prospective, planned as an adaptive double-triangular group sequential, parallel-group, randomised controlled trial with an a priori s le size of 2954 participants. Randomisation used minimisation (incorporating a random element). The trial was set in 42 secondary and community inpatient facilities in the UK. Adult inpatients with evidence of acute illness and at a high risk of PU development. APM or HSFM – the treatment phase lasted a maximum of 60 days the final 30 days were post-treatment follow-up. Time to event. From August 2013 to November 2016, 2029 participants were randomised to receive either APM ( n = 1016) or HSFM ( n = 1013). Primary end point – 30-day final follow-up: of the 2029 participants in the intention-to-treat population, 160 (7.9%) developed a new PU of category ≥ 2. There was insufficient evidence of a difference between groups for time to new PU of category ≥ 2 [Fine and Gray model HR 0.76, 95% confidence interval (CI) 0.56 to 1.04 exact p -value of 0.0890 and 2% absolute difference]. Treatment phase sensitivity analysis: 132 (6.5%) participants developed a new PU of category ≥ 2 between randomisation and end of treatment phase. There was a statistically significant difference in the treatment phase time-to-event sensitivity analysis (Fine and Gray model HR 0.66, 95% CI 0.46 to 0.93 p = 0.0176 and 2.6% absolute difference). Secondary end points – 30-day final follow-up: new PUs of category ≥ 1 developed in 350 (17.2%) participants, with no evidence of a difference between mattress groups in time to PU development, (Fine and Gray model HR 0.83, 95% CI 0.67 to 1.02 p -value = 0.0733 and absolute difference 3.1%). New PUs of category ≥ 3 developed in 32 (1.6%) participants with insufficient evidence of a difference between mattress groups in time to PU development (Fine and Gray model HR 0.81, 95% CI 0.40 to 1.62 p = 0.5530 and absolute difference 0.4%). Of the 145 pre-existing PUs of category 2, 89 (61.4%) healed – there was insufficient evidence of a difference in time to healing (Fine and Gray model HR 1.12, 95% CI 0.74 to 1.68 p = 0.6122 and absolute difference 2.9%). Health economics – the within-trial and long-term analysis showed APM to be cost-effective compared with HSFM however, the difference in costs models are small and the quality-adjusted life-year gains are very small. There were no safety concerns. Blinded photography substudy – the reliability of central blinded review compared with clinical assessment for PUs of category ≥ 2 was ‘very good’ (kappa statistic 0.82, prevalence- and bias-adjusted kappa 0.82). Quality-of-life substudy – the Pressure Ulcer Quality of Life – Prevention (PU-QoL-P) instrument meets the established criteria for reliability, construct validity and responsiveness. A lower than anticipated event rate. In acutely ill inpatients who are bedfast/chairfast and/or have a category 1 PU and/or localised skin pain, APMs confer a small treatment phase benefit that is diminished over time. Overall, the APM patient compliance, very low PU incidence rate observed and small differences between mattresses indicate the need for improved indicators for targeting of APMs and in idualised decision-making. Decisions should take into account skin status, patient preferences (movement ability and rehabilitation needs) and the presence of factors that may be potentially modifiable through APM allocation, including being completely immobile, having nutritional deficits, lacking capacity and/or having altered skin/category 1 PU. Explore the relationship between mental capacity, levels of independent movement, repositioning and PU development. Explore ‘what works for whom and in what circumstances’. Current Controlled Trials ISRCTN01151335. This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 23, No. 52. See the NIHR Journals Library website for further project information.
Publisher: Center for Open Science
Date: 04-07-2022
Abstract: Research waste relating to the production and reporting of health and medical research is a major problem. Each year, resources are wasted on research that asks the wrong questions, uses inappropriate designs, includes unrepresentative or small s les, uses incorrect methods of analysis, and is inappropriately reported, disseminated, or translated into decision-making. These issues are pertinent to (health-related) quality of life ((HR)QL) atient-reported outcome (PRO) research. In an attempt to reduce waste and maximise efficiency, the Lancet’s REWARD (REduce research Waste And Reward Diligence) C aign invited everyone involved in research to critically examine how they work to reduce waste and maximise efficiency, and to strive to improve the value of the funds invested in the research we commission, deliver, publish, and implement. However, despite nearly a decade since the Lancet series, research waste is still a major problem. In 2021, the Editors of Quality of Life Research journal issued a call for papers on reducing (HR)QL/PRO research waste and optimizing (HR)QL/PRO data. Papers in the special section discuss the many contributors to research waste and the editors, in their editorial, highlight the ongoing issues that as researchers we should all be mindful of, and potential ways in which we could all do our bit to reduce research waste in the (HR)QL/PRO field.
Publisher: Springer Science and Business Media LLC
Date: 13-11-2019
DOI: 10.1007/S11136-018-2045-7
Abstract: Patient decision-aids (PtDAs) help patients make informed treatment decisions incorporating their values. Health-related quality of life (HRQOL) is sometimes an outcome of PtDA effectiveness trials, but its suitability for this purpose is unclear. We sought to provide insights into this question by critically appraising how randomized controlled trials (RCTs) evaluating PtDA effectiveness measure and report HRQOL. We conducted a sub-analysis of RCTs included in the 2017 Cochrane review of PtDAs. Trials assessing HRQOL at baseline and post-PtDA, and comparing PtDA with comparison groups were included. Two reviewers independently extracted data and assessed study quality. Analysis was descriptive. Of 105 RCTs, 11 were eligible for inclusion. Patients randomized to PtDAs did not report better HRQOL than those randomized to usual care. While all 11 RCTs adequately described baseline s le characteristics and reported HRQOL results for study groups, few stated a priori HRQOL expectations or hypotheses (36%) made a link between HRQOL and the decision (18%) provided a rationale or justification for HRQOL assessment (18%) provided reason for choice of HRQOL assessment time-points (9%) or adjusted p-values for multiple HRQOL domains and time-points (0%). PtDAs did not conclusively impact HRQOL. If this holds generally, then HRQOL is an uninformative endpoint for PtDA effectiveness trials. When planning trials of PtDAs, investigators considering HRQOL endpoints should consider whether and why their PtDA is likely to affect HRQOL in their context, and if so, which specific aspect(s) of HRQOL and at which time-point(s), and ensure HRQOL is assessed accordingly.
Publisher: Springer Science and Business Media LLC
Date: 25-04-2020
DOI: 10.1186/S41687-020-00195-9
Abstract: Colorectal cancer (CRC) is prevalent in the developed world. Favourable survival rates highlight the need to better understand CRC survivors’ experiences of long-term impacts of treatment, which can in turn inform decision making. This systematic review aimed to identify and synthesise CRC survivors’ experiences of long-term impacts on health-related quality of life. We searched Medline, Embase and PsychINFO from inception to January 2019. Qualitative studies describing CRC survivors’ experiences at least 1-year post-treatment were included. Study eligibility, quality assessment (COREQ guidelines), and data synthesis was performed independently by two reviewers and discussed with the study team. Of 1363 papers retrieved, 20 reporting 15 studies met eligibility. Thematic synthesis produced 12 themes: symptoms, physical, social, psychological and sexual functioning, impact on relationships, informal care needs provided by family/friend, supportive care needs provided by healthcare professional, health care experiences, health behaviour, financial toxicity and occupational experiences. Stoma problems (e.g. leakage, skin irritation) were common in ostomates. Survivors with no/reversed stoma experienced unexpected, long-term altered and unpredictable bowel functioning. Survivors often regulated timing, amount and foods consumed to manage bowel functioning. Less common symptoms included fatigue, impaired sleep and anal pain. Stoma problems and altered bowel functioning impaired survivors’ physical, social, sexual and psychological functioning. Cognitive functioning and heredity issues were not reported in any paper. CRC survivors experience ongoing symptoms and functioning impairments more than 1-year post-treatment completion. Many survivors find their own ways to manage symptoms rather than seek professional help. Follow-up care for CRC survivors should integrate screening for long-term effects and provide targeted supportive care.
Publisher: Wiley
Date: 30-06-2009
DOI: 10.1111/J.1532-5415.2009.02307.X
Abstract: To identify the impact of pressure ulcers (PUs) and PU interventions on health-related quality of life (HRQL). Systematic review and metasynthesis of primary research reporting the impact of PU and PU interventions on HRQL according to direct patient reports. Quality assessment criteria were developed and applied. Data extraction identified findings in the form of direct quotes from patients or questionnaire items and domain results. Combined synthesis of qualitative and quantitative research was performed using content analysis to generate categories and themes from findings. Thirteen electronic databases were searched, and hand searching, cross-referencing, contact with experts, and an online search was undertaken. No language restrictions were applied. Adults with PUs in acute, community, and long-term care settings across Europe, the United States, Asia, and Australia. Thirty-one studies including 2,463 participants with PUs were included in the review. Ages ranged from 17 to 96. The review included 10 qualitative and 21 quantitative studies 293 findings, 46 categories, and 11 themes emerged. The 11 HRQL themes were physical impact, social impact, psychological effect, PU symptoms, general health, and other impacts of PUs: healthcare professional-client relationships, need for versus effect of interventions, impact on others, financial impact, perceived etiology, and need for knowledge. There is evidence that PUs and PU interventions have a significant impact on HRQL and cause substantial burden to patients.
Publisher: Wiley
Date: 29-07-2019
Publisher: Springer International Publishing
Date: 2019
Publisher: Elsevier BV
Date: 08-2019
DOI: 10.1111/AJT.15267
Abstract: For many patients with end-stage kidney disease, transplantation improves survival and quality of life compared with dialysis. However, complications and side effects in kidney transplant recipients can limit their ability to participate in activities of daily living including work, study, and recreational activities. The aim of this study was to identify the characteristics, content, and psychometric properties of the outcome measures used to assess life participation in kidney transplant recipients. We searched MEDLINE, Embase, PsycINFO, and CINAHL from inception to July 2018 for all studies that reported life participation in kidney transplant recipients. Two authors identified instruments measuring life participation and reviewed for characteristics. In total, 230 studies were included: 19 (8%) randomized trials, 17 (7%) nonrandomized trials, and 194 (85%) observational studies. Across these studies, we identified 29 different measures that were used to assess life participation. Twelve (41%) measures specifically assessed aspects of life participation (eg, disability assessment, daily activities of living), while 17 (59%) assessed other constructs (eg, quality of life) that included questions on life participation. Validation data to support the use of these measures in kidney transplant recipients were available for only 7 measures. A wide range of measures have been used to assess life participation in kidney transplant recipients, but validation data supporting the use of these measures in this population are sparse. A content relevant and validated measure to improve the consistency and accuracy of measuring life participation in research may inform strategies for transplant recipients to be better able to engage in their life activities.
Publisher: Springer Science and Business Media LLC
Date: 12-2018
Publisher: JMIR Publications Inc.
Date: 08-11-2017
DOI: 10.2196/RESPROT.8761
Publisher: Wiley
Date: 02-10-2012
DOI: 10.1002/MSC.1036
Abstract: Participants with rheumatoid arthritis (RA) report that foot ulceration has an impact on their health-related quality of life (HRQL) across physical, social and psychological domains. What is not known is how experiences of healthcare provision influence HRQL. The present study set out to map the patent journey while integrating the impact on HRQL. A purposive s le of RA patients with open foot ulceration was recruited from podiatry clinics in West Yorkshire (UK) between May 2008 and June 2009. Patients with diabetes were excluded (the impact of foot ulceration in this group is well established). In-depth interviews were taped and transcribed. A framework approach to data management was used to facilitate a case- and theme-based analysis. Twenty-three RA patients (18 female, five male aged 45-88 years) participated. Two themes and five sub-themes were identified. The patient journey theme comprised the following sub-themes: access to care knowledge acquisition care pathways and continuity of care. Patient-professional relationships comprised the sub-themes: therapeutic patient-professional relationships and task-orientated care. The journey took a highly variable course that was influenced by patient-specific factors (past experience of ulceration symptomology knowledge and self-efficacy) service-specific factors (access to care and care pathways) and professional-specific factors (knowing and trusting someone holism). The present study highlights the need for clearer care pathways for patients affected by foot ulceration improved patient education and better coordination of care.
Location: United Kingdom of Great Britain and Northern Ireland
Location: United Kingdom of Great Britain and Northern Ireland
Start Date: 2008
End Date: 2013
Funder: National Institute for Health Research
View Funded ActivityStart Date: 2010
End Date: 2011
Funder: University of Leeds
View Funded ActivityStart Date: 2013
End Date: 2017
Funder: National Institute for Health Research
View Funded ActivityStart Date: 2015
End Date: 2016
Funder: Cancer Council Western Australia
View Funded ActivityStart Date: 2016
End Date: 2019
Funder: Cancer Australia
View Funded Activity