Exploring the personal burden of shoulder pain among younger people in Australia: protocol for a multicentre cohort study

IntroductionPersistent musculoskeletal conditions can impact profoundly on younger people’s quality of life, psychological distress and capacity to work, as shown by previous research involving younger people with osteoarthritis. The personal impacts, in particular, work and parenting impacts, of other musculoskeletal conditions (such as persistent shoulder pain) on younger patient groups remain poorly understood. Furthermore, the personal financial burden associated with managing musculoskeletal conditions is rarely documented. This study aims to investigate well-being, work participation and productivity, shoulder-related parenting disability and out-of-pocket healthcare expenditure among younger people with shoulder pain and evaluate changes over 12 months.Methods and analysisOne hundred and fifty people aged 20–55 years with shoulder pain of more than 6 weeks’ duration (excluding those with recent history of fracture or dislocation) will be recruited for this cohort study. Participants will be recruited from three major public hospitals in Victoria, Australia, following screening of orthopaedic outpatient clinics lists and referrals. Participants will be asked to complete a baseline questionnaire and 2-week healthcare costs diary, with follow-up data collected at 12 months. Patient-reported outcomes will be collected, including health-related quality of life (HRQoL), shoulder pain and function, psychological distress, shoulder-related parenting disability and work productivity. Information on sociodemographics, employment, health services utilisation and shoulder-related healthcare expenditure will also be collected. Descriptive analysis of baseline data will provide a comprehensive snapshot of the personal burden of shoulder pain. Baseline HRQoL and psychological distress data will be compared with Australian population norms to provide context around well-being. Associations between sociodemographic factors and patient-reported outcomes will be evaluated using univariate and multivariate analyses. Changes in patient-reported outcomes from baseline to 12 months will be analysed using paired t-tests.Ethics and disseminationEthics approval has been obtained. The study findings will be submitted to peer-reviewed journals and presented at relevant scientific meetings.

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Health-Related Quality of Life Measurement in Public Health

Annual Review of Public Health ◽

10.1146/annurev-publhealth-052120-012811 ◽

2021 ◽

Vol 43 (1) ◽

Author(s):

Robert M. Kaplan ◽

Ron D. Hays

Keyword(s):

Public Health ◽

Quality Of Life ◽

Patient Reported Outcomes ◽

Well Being ◽

Publication Date ◽

Health Related Quality ◽

Patient Reported ◽

Related Quality ◽

Health Related

Patient-reported outcomes are recognized as essential for the evaluation of medical and public health interventions. Over the last 50 years, health-related quality of life (HRQoL) research has grown exponentially from 0 to more than 17,000 papers published annually. We provide an overview of generic HRQoL measures used widely in epidemiological studies, health services research, population studies, and randomized clinical trials [e.g., Medical Outcomes Study SF-36 and the Patient-Reported Outcomes Measurement Information System (PROMIS®)-29]. In addition, we review methods used for economic analysis and calculation of the quality-adjusted life year (QALY). These include the EQ-5D, the Health Utilities Index (HUI), the self-administered Quality of Well-being Scale (QWB-SA), and the Health and Activities Limitation Index (HALex). Furthermore, we consider hybrid measures such as the SF-6D and the PROMIS-Preference (PROPr). The plethora of HRQoL measures has impeded cumulative science because incomparable measures have been used in different studies. Linking among different measures and consensus on standard HRQoL measurement should now be prioritized. In addition, enabling widespread access to common measures is necessary to accelerate future progress. Expected final online publication date for the Annual Review of Public Health, Volume 43 is April 2022. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

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Patient-reported outcomes at discontinuation of anti-angiogenesis therapy in the randomized trial of chemotherapy with bevacizumab for advanced cervical cancer: an NRG Oncology Group study

International Journal of Gynecological Cancer ◽

10.1136/ijgc-2019-000869 ◽

2020 ◽

Vol 30 (5) ◽

pp. 596-601

Author(s):

Dana Chase ◽

Helen Q Huang ◽

Bradley J Monk ◽

Lois Michelle Ramondetta ◽

Richard T Penson ◽

...

Keyword(s):

Quality Of Life ◽

Cervical Cancer ◽

Patient Reported Outcomes ◽

Performance Status ◽

Well Being ◽

Treatment Discontinuation ◽

Life Assessment ◽

Recurrent Cervical Cancer ◽

Patient Reported

IntroductionTo describe patient-reported outcomes and toxicities at time of treatment discontinuation secondary to progression or toxicities in advanced/recurrent cervical cancer patients receiving chemotherapy with bevacizumab.MethodsSummarize toxicity, grade, and health-related quality of life within 1 month of treatment discontinuation for women receiving chemotherapy with bevacizumab in GOG240.ResultsOf the 227 patients who received chemotherapy with bevacizumab, 148 discontinued study protocol treatment (90 for disease progression and 58 for toxicity). The median survival time from treatment discontinuation to death was 7.9 months (95% CI 5.0 to 9.0) for those who progressed versus 12.1 months (95% CI 8.9 to 23.2) for those who discontinued therapy due to toxicities. The most common grade 3 or higher toxicities included hematologic, gastrointestinal, and pain. Some 57% (84/148) of patients completed quality of life assessment within 1 month of treatment discontinuation. Those patients who discontinued treatment due to progression had a mean decline in the FACT-Cx TOI of 3.2 points versus 2.2 in patients who discontinued therapy due to toxicity. This was a 9.9 point greater decline in the FACT-Cx TOI scores than those who discontinued treatment due to progression (95% CI 2.8 to 17.0, p=0.007). The decline in quality of life was due to worsening physical and functional well-being. Those who discontinued treatment due to toxicities had worse neurotoxicity and pain.DiscussionPatients who discontinued chemotherapy with bevacizumab for toxicity experienced longer post-protocol survival but significantly greater declination in quality of life than those with progression. Future trial design should include supportive care interventions that optimize physiologic function and performance status for salvage therapies.

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Patient-reported outcomes in congenital cardiac disease: are they as good as you think they are?

Cardiology in the Young ◽

10.1017/s1047951110001216 ◽

2010 ◽

Vol 20 (S3) ◽

pp. 143-148 ◽

Cited By ~ 10

Author(s):

Philip Moons

Keyword(s):

Quality Of Life ◽

Cardiac Disease ◽

Patient Reported Outcomes ◽

Well Being ◽

Main Question ◽

Congenital Cardiac Disease ◽

Patient Reported ◽

Satisfaction With Treatment

AbstractPatient-reported outcomes are “any outcome based on data provided by patients or patient proxy as opposed to data provided from other sources”. Examples of patient-reported outcomes are quality of life, well-being, functional status, symptoms, adherence to treatment, satisfaction with treatment, and utility or preference-based measures. The main question of this manuscript is whether patient-reported outcomes in patients with congenital cardiac disease are as good as we think they are. In general, we could say yes, because numerous studies show that patients with congenital cardiac disease have an excellent quality of life. By contrast, we could say no, because patients generally overestimate their functioning, and up to two out of three patients are not compliant with the prescribed therapy or recommendations for follow-up. However, most importantly, we have to say that we do not know whether the patient-reported outcomes are good, because research with patient-reported outcomes in congenital cardiac disease is limited. Hence, patient-reported outcomes should be a priority on the agenda for research in the domain of congenital cardiac disease.

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Comparison of Patient-Reported Outcomes at 1 Year After Injury Between Limb Salvage and Amputation: A Prospective Cohort Study

10.21203/rs.3.rs-556756/v1 ◽

2021 ◽

Author(s):

Taketo Kurozumi ◽

Takahiro Inui ◽

Yuhei Nakayama ◽

Akifumi Honda ◽

Kentaro Matsui ◽

...

Keyword(s):

Quality Of Life ◽

Mental Health ◽

Cohort Study ◽

Limb Salvage ◽

Lower Limb ◽

Prospective Cohort ◽

Patient Reported Outcomes ◽

Early Recovery ◽

Patient Reported

Abstract Background: Owing to advances in knowledge and technology, salvaging the limbs of patients with severe trauma and injuries is possible. However, severe limb injuries occasionally necessitate amputation because it allows patients to regain their social lives earlier than limb salvaging. Moreover, previous related investigations are retrospective cohort studies or meta-analyses of retrospective studies, and prospective cohort studies of patient-reported outcomes are extremely rare. This single-center, prospective cohort study aimed to compare the patient-reported outcomes at 1 year after injury between limb salvage and amputation and to elucidate whether amputation contributes to early recovery of functionality and quality of life.Methods: We included 47 limbs of 45 patients with severe open fractures of the lower limb and categorized them into limb salvage and amputation groups. They were registered in the Database of Orthopedic Trauma by the Japanese Society for Fracture Repair at our center; data on patient-reported outcomes at 1 year after injury were obtained from this database. The mean patient age was 49.6 years. Patients’ limbs were evaluated using the lower extremity functional scale (LEFS) and Short-Form 8 (SF-8). Early recovery was evaluated using functionality and quality-of-life questionnaires. Nonparametric statistical analyses were conducted.Results: Of the 47 limbs, 34 limbs of 34 patients were salvaged and 13 limbs of 11 patients were amputated. Significant differences were noted between the limb salvage and amputation groups in terms of the LEFS scores (mean: 49.5 vs 33.1, P=0.025) and scores for the mental health component (mean: 48.7 vs 38.7, P=0.003), role–physical component (mean: 42.2 vs 33.3, P=0.026), and mental component summary (mean: 48.2 vs 41.3, P=0.042) of the SF-8. The limb salvage group had better scores than the amputation group. Conclusions: In this study, limb salvage results in better functional and mental health outcomes at 1 year after severe lower limb injury than after amputation. As reconstruction technology has advanced and limb salvaging has become possible, the focus of studies should now be based on the perspective of “how the patient feels”; hence, we believe that the results of this study, which is based on patient-reported outcomes, are meaningful.

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Patient-Reported Outcomes from Heart Failure Patients Participating in the Future Patient Telerehabilitation Program: Data From the Intervention Arm of a Randomized Controlled Trial (Preprint)

10.2196/preprints.26544 ◽

2020 ◽

Author(s):

Cathrine Skov Schacksen ◽

Anne-Kirstine Dyrvig ◽

Nanna Celina Henneberg ◽

Josefine Dam Gade ◽

Helle Spindler ◽

...

Keyword(s):

Quality Of Life ◽

Heart Failure ◽

Patient Reported Outcomes ◽

Well Being ◽

Heart Failure Patients ◽

Patient Reported ◽

The Future ◽

One Year ◽

Future Patient

BACKGROUND More than 37 million people throughout the world are diagnosed with heart failure that is a growing burden on the health sector. Cardiac rehabilitation aims to improve patients’ recovery, functional capacity, psychosocial well-being, and health-related quality of life. However, cardiac rehabilitation programs have poor compliance and adherence. Telerehabilitation may be a solution to overcome some of these challenges to cardiac rehabilitation and making it more individualized. As part of the Future Patient Telerehabilitation program, a digital toolbox with the aim of enabling HF patients to monitor and evaluate their own current status has been developed and tested via data from a questionnaire (patient reported outcomes) that the patient has answered every other week (patient -reported outcomes) for one year. OBJECTIVE The aim of this sub-study is to evaluate the changes in quality of life and well-being for heart failure patients participating in the FPT Program over the course of one year. METHODS In total, 140 patients were enrolled in the Future Patient Telerehabilitation program and randomized into either the telerehabilitation group (n=70) or the control group (n=70). The patients in the telerehabilitation group answered patient reported outcomes that consisted of three components: Questions regarding the patients’ sleep patterns using the Spiegel Sleep Questionnaire. Measurements of physical limitations, symptoms, self-efficacy, social interaction and quality of life were assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). In addition, five additional questions regarding psychological well-being were developed by the research group. Of the 70 patients in the TR group, 56 answered the PRO questionnaire and completed the program, and it is these 56 patients who constitute the population for this study. RESULTS The changes in scores during one year of the study were examined using one-sample Wilcoxon signed-rank tests with a hypothesized median being 0. There were statistically significant differences in the scores in most of the slopes and intersections of the scores from the dimensions from the KCCQ and in the slopes of the patients’ overall well-being (p < 0.05). Only one dimension, the symptom stability, showed a decrease in scores over a one-year period. CONCLUSIONS The overall well-being of heart failure patients increased during one year of participating in a telerehabilitation program. There was a statistically significant increase in clinical and social well-being and quality of life during the one-year intervention period. The increase in the scores over time may indicate that the patients became more aware of their own symptoms and became better equipped to cope with disease in their everyday lives. These results suggest that patient-reported-outcome questionnaires may be used as a tool for patients in a telerehabilitation program that can both monitor and guide the patients in mastering their own symptoms CLINICALTRIAL ClinicalTrials.gov NCT03388918; https://clinicaltrials.gov/ct2/show/NCT03388918

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Yoga & Cancer Interventions: A Review of the Clinical Significance of Patient Reported Outcomes for Cancer Survivors

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2012/642576 ◽

2012 ◽

Vol 2012 ◽

pp. 1-17 ◽

Cited By ~ 20

Author(s):

S. Nicole Culos-Reed ◽

Michael J. Mackenzie ◽

Stephanie J. Sohl ◽

Michelle T. Jesse ◽

Ashley N. Ross Zahavich ◽

...

Keyword(s):

Quality Of Life ◽

Cancer Survivors ◽

Clinical Significance ◽

Patient Reported Outcomes ◽

Well Being ◽

Patient Reported ◽

Related Quality ◽

Health Related ◽

Clinically Significant

Limited research suggests yoga may be a viable gentle physical activity option with a variety of health-related quality of life, psychosocial and symptom management benefits. The purpose of this review was to determine the clinical significance of patient-reported outcomes from yoga interventions conducted with cancer survivors. A total of 25 published yoga intervention studies for cancer survivors from 2004–2011 had patient-reported outcomes, including quality of life, psychosocial or symptom measures. Thirteen of these studies met the necessary criteria to assess clinical significance. Clinical significance for each of the outcomes of interest was examined based on 1 standard error of the measurement, 0.5 standard deviation, and relative comparative effect sizes and their respective confidence intervals. This review describes in detail these patient-reported outcomes, how they were obtained, their relative clinical significance and implications for both clinical and research settings. Overall, clinically significant changes in patient-reported outcomes suggest that yoga interventions hold promise for improving cancer survivors' well-being. This research overview provides new directions for examining how clinical significance can provide a unique context for describing changes in patient-reported outcomes from yoga interventions. Researchers are encouraged to employ indices of clinical significance in the interpretation and discussion of results from yoga studies.

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Patient-Reported Outcomes and Quality of Life after Treatment for Choroidal Melanoma

Ocular Oncology and Pathology ◽

10.1159/000496927 ◽

2019 ◽

Vol 5 (6) ◽

pp. 402-411 ◽

Cited By ~ 2

Author(s):

Bertil Damato ◽

Laura Hope-Stone ◽

Bruce Cooper ◽

Steve Brown ◽

Heinrich Heimann ◽

...

Keyword(s):

Quality Of Life ◽

Metastatic Disease ◽

Tumor Recurrence ◽

Patient Reported Outcomes ◽

Choroidal Melanoma ◽

Well Being ◽

Visual Disability ◽

Patient Reported ◽

Over Time

Background/Aims: Patients with choroidal melanoma can develop psychological morbidity because of visual disability, pain, facial deformity, and fears of metastatic disease. The aim of this study was to report on the prevalence of symptoms, moods, and well-being after radiotherapy or enucleation for choroidal melanoma and how these outcomes changed over time. Methods: Participants were mailed questionnaires approximately 6 months following treatment, then annually on every anniversary of their treatment. Results: Soon after enucleation, patients experienced visual difficulties because of loss of stereopsis and visual field and were concerned about their appearance and about metastatic disease. After radiotherapy, patients were more concerned about local tumor recurrence and more troubled by diplopia and headache. Over time, visual difficulties diminished after enucleation but increased in patients who had received radiotherapy, with concerns about metastasis, loss of health, and tumor recurrence diminishing in both groups. Anxiety tended to diminish whereas depression increased, especially after enucleation. Emotional well-being improved after both kinds of treatment, whereas functional and physical well-being diminished after enucleation but improved after radiotherapy. Self-reported quality of life diminished equally with both kinds of treatment. Conclusion: The findings of this study should help physicians understand what patients tend to feel after treatment for choroidal melanoma.

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Patient-reported Outcomes, Resource Use, and Social Participation of Patients with Rheumatoid Arthritis Treated with Biologics in Alberta: Experience of Indigenous and Non-indigenous Patients

The Journal of Rheumatology ◽

10.3899/jrheum.170778 ◽

2018 ◽

Vol 45 (6) ◽

pp. 760-765 ◽

Cited By ~ 6

Author(s):

Cheryl Barnabe ◽

Louise Crane ◽

Tyler White ◽

Brenda Hemmelgarn ◽

Gilaad G. Kaplan ◽

...

Keyword(s):

Quality Of Life ◽

Rheumatoid Arthritis ◽

Resource Use ◽

Daily Living ◽

Patient Reported Outcomes ◽

Biologic Therapy ◽

Well Being ◽

Sf 36 ◽

Patient Reported

Objective.To characterize patient-reported outcomes, resource use, and social participation during the course of biologic therapy for indigenous and non-indigenous patients with rheumatoid arthritis (RA).Methods.Patients initiating biologic therapy (2004 to 2012) were characterized longitudinally for patient-reported outcomes including physical function measured by the Health Assessment Questionnaire, EQ-5D, well-being [Medical Outcomes Study Short Form-36 (SF-36)], and visual analog scales for pain, fatigue, sleep, stiffness, and patient’s global assessment. Resource use, participation in activities of daily living, and effect of RA on work productivity were also evaluated for change during therapy.Results.Indigenous patients (n = 90) presented with significantly worse scores for global evaluation, pain, sleep, quality of life, well-being, and physical function compared to non-indigenous patients (n = 1400). All patient-reported outcomes improved significantly during treatment for patients in both groups, but pain, sleep, and SF-36 physical health score changes occurred at slower rates for indigenous patients [difference in slopes 0.09 (p = 0.029), 0.08 (p = 0.043), and −0.35 (p = 0.03), respectively]. Performance of daily activities was affected for 50% of indigenous compared to 37% of non-indigenous patients, with more use of community services and assistance from others. Employed indigenous patients reported twice the number of days being unable to work owing to RA compared to employed non-indigenous patients. Of the unemployed indigenous patients, 82% indicated they had stopped working because of arthritis, versus 48% of non-indigenous patients (p < 0.0001).Conclusions.Indigenous patients have greater consequences of RA regarding experienced symptoms, health-related quality of life, disruption of performance of activities of daily living, and reduced employment participation.

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Quality of life and experiences of sarcoma trajectories (the QUEST study): protocol for an international observational cohort study on diagnostic pathways of sarcoma patients

BMJ Open ◽

10.1136/bmjopen-2020-039309 ◽

2020 ◽

Vol 10 (10) ◽

pp. e039309

Author(s):

Vicky Soomers ◽

Ingrid ME Desar ◽

Lonneke V van de Poll-Franse ◽

Olga Husson ◽

Winette TA van der Graaf

Keyword(s):

Quality Of Life ◽

Cohort Study ◽

Soft Tissue ◽

Soft Tissue Sarcoma ◽

The Netherlands ◽

Patient Reported Outcomes ◽

Tumour Size ◽

Patient Reported ◽

Total Interval

IntroductionSarcomas are rare tumours with considerable heterogeneity. Early and accurate diagnosis is important to optimise patient outcomes in terms of local disease control, overall survival (OS) and health-related quality of life (HRQoL). Time to diagnosis is variable in bone as well as soft tissue sarcoma. Possible factors for a long time from first symptom to diagnosis (the total interval) include patient, tumour and healthcare characteristics, but until now the most relevant risk factors and its association with outcomes remain unknown. Our study aims to (1) quantify total interval, the time interval from first symptom until (histological) diagnosis; (2) identify factors associated with interval length and (3) determine the association between total interval and HRQoL, stage and tumour size at diagnosis, progression-free survival (PFS) and OS.Methods and analysisWe will conduct a longitudinal, prospective, international, multicentre cohort study among patients aged ≥18 years with newly diagnosed bone or soft tissue sarcoma at eight centres (three in UK, five in The Netherlands). Patients will be asked to complete questionnaires at five points in time; one at diagnosis and at follow-up points of 3, 6, 12 and 24 months. Questionnaire data is collected within the Patient Reported Outcomes Following Initial treatment and Long term Evaluation of Survivorship (PROFILES) registry: an international data management system for collection of patient-reported outcomes. Clinical data will be extracted from patient records. The primary endpoint is HRQoL at diagnosis, measured with the EORTC QLQ-C30. Secondary endpoints are stage and tumour size at diagnosis, PFS, OS, additional patient-reported outcomes, such as quality-adjusted life years and psychological distress.Ethics and disseminationEthical approval was given by the Health Research Authority and Research Ethics Committee for the United Kingdom (18/WA/0096) and medical ethical committee of Radboudumc for The Netherlands (2017-3881). Results will be presented in peer-reviewed journals and presented at meetings.Trial registration numberNCT03441906.

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