Development of a patient reported outcome questionnaire to measure the impact of postpartum blood loss in women with moderate and severe anaemia: A study using a multi-faceted approach

Background: Globally, over one-third of pregnant women are anaemic and are at increased risk of postpartum haemorrhage (PPH). Tranexamic acid (TXA) given within 3 hours of birth significantly reduces death due to bleeding in women with PPH. However, for many, treatment is too late to prevent death from PPH. The WOMAN-2 trial aims to see if giving TXA can prevent PPH and other outcomes in women with moderate and severe anaemia. Assessing the impact of postpartum blood loss on women’s own perceptions of their health and well-being is an important outcome for the WOMAN-2 trial. This study aimed to develop a conceptual framework and questionnaire to measure the impact of postpartum blood loss on participant-reported outcomes (PRO) in women with moderate and severe anaemia. Methods: A conceptual framework and PRO questionnaire were developed using a multifaceted, iterative process. Factors influencing anaemic women’s postpartum experience were identified from review of the literature and through group discussion with them. De novo items were combined with those from an existing instrument (Multi-dimensional Fatigue Symptom Inventory, Short Form (MFSI-SF)). Content validity was tested among a group of obstetricians and anaemic postpartum women, revised and then pilot tested among 124 women with moderate and severe anaemia following vaginal birth. Results: Women with moderate and severe anaemia who experienced PPH reported more fatigue on the MFSI-SF (p=0.001); reported feeling more ill (p=0.004); and had greater difficulty breastfeeding (p=0.039), compared to those who did not experience PPH. Compared to women with moderate anaemia, women with severe anaemia reported experiencing worse symptoms of anaemia (p=0.001) and scored worse on the MFSI-SF (p=0.007). Conclusions: Significant differences between the scores of women who developed PPH and those who did not and the scores between women with moderate and severe anaemia indicate that the questionnaire had satisfactory construct validity.

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Development of a patient reported outcome questionnaire to measure the impact of postpartum blood loss in women with moderate and severe anaemia: A study using a multi-faceted approach

Wellcome Open Research ◽

10.12688/wellcomeopenres.15245.2 ◽

2021 ◽

Vol 4 ◽

pp. 85

Author(s):

Lori Miller ◽

Shahana Chaudhri ◽

Danielle Beaumont ◽

Aasia Kayani ◽

Kiran Javid ◽

...

Keyword(s):

Blood Loss ◽

Conceptual Framework ◽

Short Form ◽

Well Being ◽

Severe Anaemia ◽

Postpartum Blood Loss ◽

Increased Risk ◽

Patient Reported ◽

Process Factors ◽

The Impact

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The impact of prepartum factor XIII activity on postpartum blood loss

10.1055/s-0039-3401109 ◽

2019 ◽

Author(s):

C Haslinger ◽

W Korte ◽

T Hothorn ◽

R Brun ◽

C Greenberg ◽

...

Keyword(s):

Blood Loss ◽

Factor Xiii ◽

Postpartum Blood Loss ◽

The Impact

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Vision-related quality of life in adults with severe peripheral vision loss: a qualitative interview study

Journal of Patient-Reported Outcomes ◽

10.1186/s41687-020-00281-y ◽

2021 ◽

Vol 5 (1) ◽

Author(s):

Ryan Lange ◽

Abigail Kumagai ◽

Sara Weiss ◽

Katherine B. Zaffke ◽

Sherry Day ◽

...

Keyword(s):

Quality Of Life ◽

Contrast Sensitivity ◽

Qualitative Interviews ◽

Well Being ◽

Vision Impairment ◽

Qualitative Interview Study ◽

Patient Reported ◽

Related Quality ◽

The Impact

Abstract Background Existing patient-reported outcome (PRO) measures may not be relevant to the full range of functional and vision-related quality of life (VR-QOL) concerns of individuals with vision impairment due to severe peripheral field loss (PFL). Measurement of VR-QOL in severe PFL is important in order to determine the effectiveness of vision rehabilitation interventions for this population. The purpose of this study was to characterize the impact of severe PFL due to retinitis pigmentosa (RP) and glaucoma on VR-QOL as the initial phase in the development of a novel PRO measure. Methods Individuals with severe PFL due to RP or glaucoma were recruited from the Kellogg Eye Center and the Association for the Blind and Visually Impaired. Participants completed semi-structured qualitative interviews, the Impact of Vision Impairment (IVI) questionnaire and the RAND 36-Item Health Survey. Interviews were analyzed by two coders using thematic analysis. A matrix analysis was conducted to compare VR-QOL by cause of severe PFL. Sample size was determined by thematic saturation. Results The study included 37 participants (19 RP, 18 glaucoma). Median best-corrected visual acuity for those with RP and glaucoma was 20/40 and 20/27.5, while Pelli-Robson contrast sensitivity was 1.2 log contrast sensitivity (logCS) and 1.1 logCS, respectively. Median domain scores on the IVI (reading, mobility, well-being) ranged from a low of − 0.2 to a high of 0.7 logits in those with RP and from 0.5 to 1.2 logits in those with glaucoma. Qualitative interviews identified six VR-QOL themes relevant across participants with both RP and glaucoma, including activity limitations, driving, emotional well-being, reading, mobility, and social function. VR-QOL concerns were largely consistent among those with severe PFL due to RP and glaucoma. These overarching themes contained content relevant to specific challenges related to severe PFL. Conclusions There are commonly occurring VR-QOL concerns among individuals with severe PFL due to RP and glaucoma. The outlined themes will serve as the basis for development of the Low Vision Severely Constricted Peripheral Eyesight (LV-SCOPE) Questionnaire.

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Patient-Reported Outcome Measures in Colorectal Surgery: Construction of Core Measures Using Open-Source Research Method

Surgical Innovation ◽

10.1177/1553350621998871 ◽

2021 ◽

pp. 155335062199887

Author(s):

Alaa El-Hussuna ◽

Ines Rubio-Perez ◽

Monica Millan ◽

Gianluca Pellino ◽

Ionut Negoi ◽

...

Keyword(s):

Colorectal Surgery ◽

Outcome Measures ◽

Short Form ◽

Wide Spectrum ◽

Core Outcome Set ◽

Well Being ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Patient Reported ◽

Eortc Qlq

Purpose. The primary aim of the study was to review the existing literature about patient-reported outcome measures (PROMs) in colorectal cancer and IBD. The secondary aim was to present a road map to develop a core outcome set via opinion gathering using social media. Method. This study is the first step of a three-step project aimed at constructing simple, applicable PROMs in colorectal surgery. This article was written in a collaborative manner with authors invited both through Twitter via the #OpenSourceResearch hashtag. The 5 most used PROMs were presented and discussed as slides/images on Twitter. Inputs from a wide spectrum of participants including researchers, surgeons, physicians, nurses, patients, and patients’ organizations were collected and analyzed. The final draft was emailed to all contributors and 6 patients’ representatives for proofreading and approval. Results. Five PROM sets were identified and discussed: EORTC QLQ-CR29, IBDQ short health questionnaire, EORTC QLQ-C30, ED-Q5-5L, and Short Form-36. There were 315 tweets posted by 50 tweeters with 1458 retweets. Awareness about PROMs was generally limited. The general psycho-physical well-being score (GPP) was suggested and discussed, and then a survey was conducted in which more than 2/3 of voters agreed that GPP covers the most important aspects in PROMs. Conclusion. Despite the limitations of this exploratory study, it offered a new method to conduct clinical research with opportunity to engage patients. The general psycho-physical well-being score suggested as simple, applicable PROMs to be eventually combined procedure-specific, disease-specific, or symptom-specific PROMs if needed.

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COPD, Depression and COVID-19 Pandemic: A Harrowing, Demoralizing and Deleterious Triad

Clinical Medical Reviews and Reports ◽

10.31579/2690-8794/095 ◽

2021 ◽

Vol 3 (8) ◽

pp. 01-06

Author(s):

Iqbal Akhtar Khan ◽

Hamza Iltaf Malik

Keyword(s):

Hospital Admissions ◽

Hospital Readmissions ◽

Public Health Problem ◽

Well Being ◽

Care Utilization ◽

Global Public Health ◽

Increased Risk ◽

Co Morbidity ◽

Pulmonary Manifestations ◽

The Impact

COPD is a highly incapacitating global public health problem, with pulmonary and extra-pulmonary manifestations and usually associated with significant concomitant chronic diseases. With enhanced understanding, it has extensively been reported as a complex, heterogeneous and dynamic disease affecting patients’ health beyond pulmones. Depression, with prevalence of 322 million people, is a major contributor to the overall global burden of disease. In various epidemiological and clinical studies, its prevalence among patients with COPD varies from 18% to 80%. This deadly duo leads to excessive health care utilization rates and costs including increased rates of exacerbation, sub-optimal adherence to prescribed medications, increased hospital admissions, longer hospital stays and increased hospital readmissions. Moreover, there is increased risk of suicidal ideation, suicidal attempts, and suicidal drug overdose. It is a pity that, in significant cases, the co-morbidity remains under-recognized and under-treated. The impact of prevailing COVID 19 pandemic, on the dual burden of COPD and depression, and possible remedial measures including “The 6 ways to boost one’s well-being-by Mental Heath UK, “The Living with the Times” toolkit--by WHO” and innovative add-ons like Dance Movement Therapy and Musical Engagement Therapy have been discussed.

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The impact of coronavirus disease 2019 (COVID-19) on older adults with an intellectual disability during the first wave of the pandemic in Ireland

HRB Open Research ◽

10.12688/hrbopenres.13238.2 ◽

2021 ◽

Vol 4 ◽

pp. 93

Author(s):

Mary McCarron ◽

Darren McCausland ◽

Retha Luus ◽

Andrew Allen ◽

Fintan Sheerin ◽

...

Keyword(s):

Intellectual Disability ◽

Repeated Measures ◽

Well Being ◽

Adverse Outcomes ◽

Multiple Infection ◽

Similar Proportion ◽

Related Data ◽

Increased Risk ◽

The Impact ◽

Health And Well Being

Background: People with intellectual disability have increased risk of exposure to and adverse outcomes from coronavirus disease 2019 (COVID-19).They also face challenges to mental health and well-being from COVID-19-related social restrictions and service closures. Methods: Data from a supplemental COVID-19 survey from the Intellectual Disability Supplement to the Irish Longitudinal Study on Ageing (IDS-TILDA) (n=710) was used to assess outcomes from the first infection wave of COVID-19 among adults with intellectual disability aged 40+ years in Ireland. Data was gathered on testing, for symptoms and outcomes; procedures to manage COVID-19; and both stress/anxiety and positive experiences during the pandemic. Demographic and health-related data from the main IDS-TILDA dataset was included in analyses. Results: High rates were identified of health conditions associated with poorer COVID-19 outcomes, including overweight/obesity (66.6%, n=365), high cholesterol (38.6%, n=274) and cardiovascular disease (33.7%, n=239). Over half (53.5%, n=380) reported emotional, nervous or psychiatric disorders. Almost two-thirds (62.4%, n=443) were tested for COVID-19, with 10% (n=71) reporting symptoms and 2.5% (n=11) testing positive. There were no instances of COVID-19 related mortality. Common symptoms included fatigue, fever, and cough. Some participants (7.8%, n=55) moved from their usual home, most often to isolate (n=31) or relocate to a family home (n=11). Three-quarters (78.7%) of those who were symptomatic or who tested positive had plans to manage self-isolation and two-thirds were able to comply with guidelines. Over half (55%, n=383) reported some COVID-19 related stress/anxiety; and a similar proportion reported positive aspects during this period (58%, n=381). Conclusions: Our data suggests that people with intellectual disability avoided the worst impacts of COVID-19 during the first infection wave in Ireland. Nevertheless, participants’ health profiles suggest that this population remains at high risk for adverse infection outcomes. Repeated measures are needed to track health and well-being outcomes across multiple infection waves.

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Perceived functioning, well-being and psychiatric symptoms in patients with stable schizophrenia treated with long-acting risperidone for 1 year

The British Journal of Psychiatry ◽

10.1192/bjp.187.2.131 ◽

2005 ◽

Vol 187 (2) ◽

pp. 131-136 ◽

Cited By ~ 63

Author(s):

W. Wolfgang Fleischhacker ◽

Jonathan Rabinowitz ◽

Georg Kemmler ◽

Mariëlle Eerdekens ◽

Angelika Mehnert

Keyword(s):

Mental Component Summary ◽

Psychiatric Symptoms ◽

Short Form ◽

Mental Component Summary Score ◽

Well Being ◽

Psychotic Symptoms ◽

Open Label ◽

Sf 36 ◽

Patient Reported ◽

Long Acting

BackgroundThe extent to which antipsychotics improve patients' well-being is uncertain.AimsTo examine psychopathology and patient-rated functioning and well-being in patients treated with risperidone.MethodIn a 1-year, open-label, international multicentre trial of long-acting risperidone in 615 stable adult patients with schizophrenia, self-rated functioning and well-being were measured every 3 months using the Short Form 36-item questionnaire (SF–36). Psychopathology was quantified using the Positive and Negative Syndrome Scale (PANSS).ResultsSignificant improvements were found on the SF–36 mental component summary score and vitality and social functioning scales. PANSS and mental component summary scores were moderately correlated.ConclusionsPatient-reported functioning and well-being appear to differ from investigator-rated psychotic symptoms. Patient-rated well-being should be assessed with symptoms to help measure treatment outcomes.

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P1062EXPANDED DIALYSIS (HDX): IS THERE AN IMPACT ON PATIENT REPORTED SYMPTOM?

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfaa142.p1062 ◽

2020 ◽

Vol 35 (Supplement_3) ◽

Author(s):

Jarrin Penny ◽

Fabio R Salerno ◽

Lisa Hur ◽

Christopher McIntyre

Keyword(s):

Quality Of Life ◽

Clinical Outcomes ◽

Symptom Burden ◽

Well Being ◽

Response To Therapy ◽

High Flux ◽

Patient Reported ◽

Dialysis Membranes ◽

The Impact

Abstract Background and Aims High flux dialysis membranes sufficiently remove smaller sized uremic toxins however, the accumulation and retention of larger middle molecular weight toxins, which are associated with chronic inflammation, cardiovascular disease and suboptimal outcomes are poorly cleared. The recent advent of medium-cut-off dialysis membranes, labelled “expanded dialysis” (HDx) are permeable to molecules of larger size responsible for poor clinical outcomes. However, it remains unclear if HDx can directly impact the symptoms associated with hemodialysis (HD). Symptom burden plays a significant role in quality of life (QOL) and mortality rates in the HD population. The London Evaluation of Illness (LEVIL), an application-based platform has been developed to measure patient reported outcomes (PROM). In comparison to cross-sectional PROM’s, LEVIL more accurately represents the fluctuations in daily symptoms and the impact of intervention. LEVIL evaluates general well-being, energy, sleep, appetite, pain and breathing, all of which are outcomes of interest on symptom burden in chronic kidney disease. Our aim was to determine if HDx therapy had any effect on symtoms/QOL domains using LEVIL. Method 28 patients from two dialysis centers in London Ontario were consented to participate. Patients were required to be over 18 years of age and on conventional thrice weekly maintenance HD for at least three months. 23 participants completed study and analyzed (five lost for various reasons). Baseline (BL) symptom characteristics were obtained while using high flux membrane for two weeks. Symptoms continued to be measured throughout the 12 weeks of HDx therapy two-three times weekly using LEVIL. Laboratory biomarkers including beta-2 microglobulin and free-light chains were collected at baseline and after 12 weeks of HDx therapy. Results Patients were stratified into tertiles (high/middle/low) using mean values of BL symptoms scores in each domain (wellbeing, energy, sleep, appetite, pain, breathing). Those in the high BL group were labeled as “control”. Low and middle BL measures were further stratified into responders vs. non-responders (responders were considered to have a 50% increase in any symptom domain by ≥50%). Of those domains which responded to HDx, 76% also had low BL scores with 27% having middle BL scores. General wellbeing, energy and sleep were domains with the greatest response reaching statistical significance after eight weeks of therapy. HDx had limited effect on appetite, pain and breathing. Although stratification was per domain, overall, 74% of the population studied did respond in at least one domain, with some responding in as many as five. Conclusion HDx using Theranova (Baxter) shows the most benefit in domains with low BL measures. Additionally, not everyone who had low BL scores responded after 12 weeks of therapy, leaving us to question whether HDx may have a latent effect in some individuals/populations. Those who had no response to therapy in certain domains also had greater baseline quality of life respectively. This information may assist in decision making/rationale for the utilization and implementation of such therapy. Although more work is required to further stratify symptoms in relation to demographic/biochemical finding and clinical outcomes. It is evident that HDx improves patient reported symptoms and QOL.

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The impact of fly-in, fly-out (FIFO) on the health and well-being of employees: what organisations can do to mitigate the risks and improve outcomes

The APPEA Journal ◽

10.1071/aj19146 ◽

2020 ◽

Vol 60 (2) ◽

pp. 397

Author(s):

Elizabeth Brook ◽

Melanie Freeman ◽

Graeme Ditchburn

Keyword(s):

Mental Health ◽

Well Being ◽

Perceived Support ◽

Work Family Conflict ◽

Code Of Practice ◽

Increased Risk ◽

Work Family ◽

The Impact ◽

Levels Of Support ◽

Health And Well Being

Concerns about the increased risk to mental health in fly-in, fly-out (FIFO) workers in the construction and resources industries led to increased public and government scrutiny, resulting in Western Australia’s adoption of a code of practice. In general, research has found that a higher incidence of psychological distress in FIFO workers has resulted from high compression rosters and work–family conflict, as well as feelings of isolation. Risk controls, such as perceived levels of support, have been found to be significantly related to improved mental health and organisational outcomes. Organisations need to address the non-financial needs of their workers and look to develop their perceived support, job satisfaction and adjustment to the FIFO lifestyle. This paper outlines practical risk controls and interventions organisations can take to improve psychological and organisational outcomes.

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Impact of Medium Cut-Off Dialyzers on Patient-Reported Outcomes: COREXH Registry

Blood Purification ◽

10.1159/000508803 ◽

2020 ◽

pp. 1-9

Author(s):

Juan Carlos Alarcon ◽

Alfonso Bunch ◽

Freddy Ardila ◽

Eduardo Zuñiga ◽

Jasmin I. Vesga ◽

...

Keyword(s):

Quality Of Life ◽

Kidney Disease ◽

Repeated Measures ◽

Patient Reported Outcomes ◽

Short Form ◽

High Flux ◽

Middle Molecules ◽

Patient Reported ◽

The Impact

Introduction: A new generation of hemodialysis (HD) membranes called medium cut-off (MCO) membranes possesses enhanced capacities for middle molecule clearance, which have been associated with adverse outcomes in this population. These improvements could potentially positively impact patient-reported outcomes (PROs). Objective: The objective of this study was to evaluate the impact of MCO membranes on PROs in a cohort of HD patients in Colombia. Methods: This was a prospective, multicenter, observational cohort study of 992 patients from 12 renal clinics in Colombia who were switched from high-flux HD to MCO therapy and observed for 12 months. Changes in Kidney Disease Quality of Life 36-Item Short Form Survey (KDQoL-SF36) domains, Dialysis Symptom Index (DSI), and restless legs syndrome (RLS) 12 months after switching to MCO membranes were compared with time on high-flux membranes. Repeated measures of ANOVA were used to evaluate changes in KDQoL-SF36 scores; severity scoring was used to assess DSI changes over time; Cochran’s Q test was used to evaluate changes in frequency of diagnostic criteria of RLS. Results: During 12 months of follow-up, 3 of 5 KDQoL-SF36 domains improved compared with baseline: symptoms (p < 0.0001), effects of kidney disease (p < 0.0001), and burden of kidney disease (p < 0.001). The proportion of patients diagnosed with RLS significantly decreased from 22.1% at baseline to 10% at 12 months (p < 0.0001). No significant differences in the number of symptoms (DSI, p = 0.1) were observed, although their severity decreased (p = 0.009). Conclusions: In conventional HD patients, the expanded clearance of large middle molecules with MCO-HD membranes was associated with higher health-related quality of life scores and a decrease in the prevalence of RLS.

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