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"Health-related positive outcomes"
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What are the effective elements in patient-centered and multimorbidity care? A scoping review
2018
Background
Interventions to improve patient-centered care for persons with multimorbidity are in constant growth. To date, the emphasis has been on two separate kinds of interventions, those based on a patient-centered care approach with persons with chronic disease and the other ones created specifically for persons with multimorbidity. Their effectiveness in primary healthcare is well documented. Currently, none of these interventions have synthesized a patient-centered care approach for care for multimorbidity. The objective of this project is to determine the particular elements of patient-centered interventions and interventions for persons with multimorbidity that are associated with positive health-related outcomes for patients.
Method
A scoping review was conducted as the method supports the rapid mapping of the key concepts underpinning a research area and the main sources and types of evidence available. A five-stage approach was adopted: (1) identifying the research question; (2) identifying relevant studies; (3) selecting studies; (4) charting the data; and (5) collating, summarizing and reporting results. We searched for interventions for persons with multimorbidity or patient-centered care in primary care. Relevant studies were identified in four systematic reviews (Smith et al. (2012;2016), De Bruin et al. (2012), and Dwamena et al. (2012)). Inductive analysis was performed.
Results
Four systematic reviews and 98 original studies were reviewed and analysed. Elements of interventions can be grouped into three main types and clustered into seven categories of interventions: 1) Supporting decision process and evidence-based practice; 2) Providing patient-centered approaches; 3) Supporting patient self-management; 4) Providing case/care management; 5) Enhancing interdisciplinary team approach; 6) Developing training for healthcare providers; and 7) Integrating information technology. Providing patient-oriented approaches, self-management support interventions and developing training for healthcare providers were the most frequent categories of interventions with the potential to result in positive impact for patients with chronic diseases.
Conclusion
This scoping review provides evidence for the adaption of patient-centered interventions for patients with multimorbidity. Findings from this scoping review will inform the development of a toolkit to assist chronic disease prevention and management programs in reorienting patient care.
Journal Article
Patient-reported outcomes in the phase 3 BFORE trial of bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia
by
Mamolo, Carla
,
Deininger, Michael W
,
Crescenzo, Rocco
in
Cancer
,
Cancer therapies
,
Chronic myeloid leukemia
2019
BackgroundIn the phase 3 BFORE trial (NCT02130557), treatment with bosutinib resulted in a significantly higher major molecular response rate at 12 months versus imatinib in the modified intent-to-treat (mITT) population of patients with newly diagnosed chronic phase chronic myeloid leukemia (CP CML). Assessment of patient-reported outcomes (PROs) was an exploratory objective.MethodsPatients with newly diagnosed CP CML were randomized 1:1 to receive once-daily bosutinib 400 mg or imatinib 400 mg as first-line therapy. Patients completed the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) and EuroQoL-5 Dimensions (EQ-5D) questionnaires at baseline, every 3 months for the first 24 months of treatment, every 6 months thereafter, and at treatment completion. We report PRO results at month 12 in the mITT population (bosutinib: n = 246; imatinib: n = 241).ResultsMean FACT-Leu combined and subscale scores were similar at baseline in the bosutinib and imatinib arms; at month 12, all scores demonstrated improvement or maintenance of health-related quality of life (HRQoL) in both treatment arms. Repeated-measures mixed-effects models showed no significant difference between bosutinib and imatinib for any FACT-Leu score. Functional health status, as measured by EQ-5D, also demonstrated improvement or maintenance with bosutinib and imatinib at month 12.ConclusionsSimilar improvements in PROs compared with baseline were seen after 12 months of treatment with first-line bosutinib or imatinib in the BFORE trial. Newly diagnosed patients with CP CML receiving bosutinib or imatinib can preserve or improve HRQoL during treatment, although clinical efficacy was superior with bosutinib.
Journal Article
Impact of High-Intensity-NIV on the heart in stable COPD: a randomised cross-over pilot study
by
Magnet, Friederike Sophie
,
Storre, Jan Hendrik
,
Meissner, Axel
in
Aged
,
Cardiac output
,
Causality
2017
Background
Although high-intensity non-invasive ventilation has been shown to improve outcomes in stable COPD, it may adversely affect cardiac performance. Therefore, the aims of the present pilot study were to compare cardiac and pulmonary effects of 6 weeks of low-intensity non-invasive ventilation and 6 weeks of high-intensity non-invasive ventilation in stable COPD patients.
Methods
In a randomised crossover pilot feasibility study, the change in cardiac output after 6 weeks of each NIV mode compared to baseline was assessed with echocardiography in 14 severe stable COPD patients. Furthermore, CO during NIV, gas exchange, lung function, and health-related quality of life were investigated.
Results
Three patients dropped out: two deteriorated on low-intensity non-invasive ventilation, and one presented with decompensated heart failure while on high-intensity non-invasive ventilation. Eleven patients were included in the analysis. In general, cardiac output and NTproBNP did not change, although individual effects were noticed, depending on the pressures applied and/or the co-existence of heart failure. High-intensity non-invasive ventilation tended to be more effective in improving gas exchange, but both modes improved lung function and the health-related quality of life.
Conclusions
Long-term non-invasive ventilation with adequate pressure to improve gas exchange and health-related quality of life did not have an overall adverse effect on cardiac performance. Nevertheless, in patients with pre-existing heart failure, the application of very high inspiratory pressures might reduce cardiac output.
Trial registration
The trial was registered in the Deutsches Register Klinischer Studien (DRKS-ID:
DRKS00007977
).
Journal Article
Patterns of occurrence and implications of neratinib-associated diarrhea in patients with HER2-positive breast cancer: analyses from the randomized phase III ExteNET trial
by
Schmid, Kendra
,
Jahanzeb, Mohammad
,
Di Palma, Jack
in
Adjuvant chemotherapy
,
Administration, Oral
,
Adult
2019
Background
We characterized patterns of occurrence and the impact of neratinib-associated diarrhea in the absence of protocol-directed antidiarrheal prophylaxis or a formal diarrhea management plan using data from Extended Adjuvant Treatment of Breast Cancer with Neratinib (ExteNET).
Methods
ExteNET is a multicenter, double-blind, placebo-controlled, randomized phase III trial involving community-based and academic institutions in 40 countries. Women with HER2-positive early-stage breast cancer with prior standard primary therapy and trastuzumab-based (neo)adjuvant therapy were randomized to neratinib 240 mg/day or placebo for 12 months. Safety, a secondary outcome, was assessed using the National Cancer Institute Common Terminology Criteria version 3.0. Health-related quality of life by diarrhea grade was assessed using Functional Assessment of Cancer Therapy-Breast (FACT-B).
Results
Two thousand eight hundred sixteen women (1408 per group) were safety-evaluable. Grade 3 and 4 diarrhea occurred in 561 (39.8%) and 1 (0.1%) patients with neratinib versus 23 (1.6%) and 0 patients with placebo, respectively. In the neratinib group, 28.6% of patients had grade 3 events during month 1 decreasing to ≤ 6% after month 3. The median cumulative duration of grade 3/4 diarrhea with neratinib was 5 days (interquartile range, 2–9). Serious diarrheal events (
n
= 22, 1.6%) and diarrheal events requiring hospitalization (
n
= 20, 1.4%) were rare with neratinib. Changes in FACT-B total score by diarrhea grade in the neratinib group did not meet the threshold for clinically important differences.
Conclusions
In the absence of antidiarrheal prophylaxis, neratinib-related diarrhea is short-lived and not associated with complications or long-term sequelae. This suggests that targeted preventive management with antidiarrheal prophylaxis early during neratinib treatment is appropriate.
Trial registration
ClinicalTrials.gov
NCT00878709. Registered 9 April 2009.
Journal Article
CPAP treatment in REM-related obstructive sleep apnea: a distinct clinical phenotype of sleep disordered breathing
2021
PurposeREM-related obstructive sleep apnea (REM-OSA), as defined using revised apnea-hypopnea index (AHI) criteria, might represent a specific OSA phenotype. However, there is a lack of data on outcomes of treatment in this population. This study evaluated the effects of CPAP treatment over 12 months on clinical outcomes for patients with the polysomnography phenotype of REM-OSA.MethodsWe conducted a prospective observational study with the following inclusion criteria: subjective sleepiness and diagnostic polysomnography demonstrating AHIREM≥15 events/h, AHINREM<5 events/h, and ≥ 30 min of REM sleep. Clinical outcomes assessed included Epworth Sleepiness Scale (ESS), psychomotor vigilanc test reaction time (PVT-RT), and CPAP adherence at baseline, 1, 3, 6, and 12 months; Functional Outcomes of Sleep Questionnaire (FOSQ) and Depression Anxiety Stress Scales (DASS-21) at baseline, 1, 3 and 12 months. The reason is the first 3 outcomes (ESS, PVT, adherence) were assessed at baseline, 1, 3, 6, and 12 months, while the next 2 outcomes (FOSQ, DASS) were assessed at baseline, 1, 3, and 12 months. The edited version is not as clear in separating these outcomes into 2 groups; Functional Outcomes of Sleep Questionnaire (FOSQ); and Depression Anxiety Stress Scales (DASS-21) at baseline, 1, 3, and 12 months. Linear mixed effects models were used to investigate the joint effects of time and average CPAP adherence on our outcomes of interest.ResultsTwenty participants completed a minimum of 1 month of CPAP treatment and were included for analysis. During the trial, 8 participants discontinued CPAP (4 before 3 months, 1 before 6 months, 3 before 12 months), and 19 participants completed 12 months of treatment. Baseline ESS was elevated at 12.6 units. Average CPAP usage for all 27 participants over 12 months was 2.9 ± 2.4 h. There was a significant decrease in ESS and increase in FOSQ at all time points, and the decrease in ESS was only seen in the CPAP-adherent subgroup. Decreases in DASS-21 and PVT-RT were not sustained.ConclusionsCPAP treatment in sleepy patients with moderate to severe REM-OSA is associated with reduced sleepiness and improved quality of life.Trial registrationThe trial was registered in the Australian New Zealand Clinical Trials Registry: ACTRN12620000576921, 18/05/2020 (retrospectively registered).
Journal Article
Patient-Reported Outcomes of Maxillomandibular Surgery for Obstructive Sleep Apnea Treatment: A Scoping Review
by
Vale, Francisco
,
Marques, Filipa
,
Marto, Carlos Miguel
in
Adults
,
Care and treatment
,
Clinical outcomes
2024
(1) Background: The present scoping review aims to scrutinize all existing patient-reported outcomes and assess the perspectives of obstructive sleep apnea patients after maxillomandibular surgery. (2) Methods: The review was carried out according to the extensions for scoping reviews using the PRISMA-ScR guidelines. Several databases were used to carry out the initial search. This study included randomized controlled trials, cohort studies, cross-sectional and case-control studies. The included studies considered patients with obstructive sleep apnea who were submitted to orthognathic surgery as the main subjects, and the patient’s perception of quality of life, satisfaction, treatment experience and side effects were assessed. (3) Results: From 1407 examined articles, a total of 16 were included. Most of the included studies used more than one questionnaire to assess quality of life, except for five articles. The most commonly referred instruments were the Epworth Sleepiness Scale, SF-36, the Functional Outcomes of Sleep and Ottawa Sleep Apnea. The most commonly assessed outcomes were sleep quality, daytime function, facial aesthetics, dental function and emotional health. (4) Conclusions: The number of variables that can be evaluated from a patient’s perspective are endless, as are the tools available to assess them. Not all of these tools, which are generally questionnaires, assess all the various outcomes, and some do not compare the pre- and post-surgical situations. Most of them are generic and lack specificity for obstructive sleep apnea.
Journal Article
Pre-Surgery Patient Health Contributes to Aggravated Sino-Nasal Outcome and Quality of Life after Pituitary Adenomectomy
by
Taku Sato
,
Oliver Gembruch
,
Yahya Ahmadipour
in
adenomectomy
,
Continuous positive airway pressure
,
ddc:610
2023
Objectives: The transphenoidal bi-nostril endoscopic resection of pituitary adenomas is regarded as a minimally invasive treatment nowadays. However, sino-nasal outcome and health-related quality of life (HRQoL) might still be impaired after the adenomectomy, depending on patients’ prior medical history and health status. A systematic postoperative comparison is required to assess differences in perceived sino-nasal outcome and HRQoL. Methods: In this single-center observational study, we collected data from 81 patients, operated between August 2016 and August 2021, at a 3–6-month follow-up after adenomectomy. We employed the sino-nasal outcome test for neurosurgery (SNOT-NC) and the HRQoL inventory Short Form (SF)-36 to compare sino-nasal and HRQoL outcome in patients with or without allergies, previous nose surgeries, presence of pain, snoring, sleep apnea, usage of continuous positive airway pressure (cpap), and nose drop usage. Results: At the 3–6-month follow-up, patients with previous nasal surgery showed overall reduced subjective sino-nasal health, increased nasal and ear/head discomfort, increased visual impairment, and decreased psychological HRQoL (all p ≤ 0.026) after pituitary adenomectomy. Patients with pain before surgery showed a trend-level aggravated physical HRQoL (p = 0.084). Conclusion: Our data show that patients with previous nasal surgery have an increased risk of an aggravated sino-nasal and HRQoL outcome after pituitary adenomectomy. These patients should be thoroughly informed about potential consequences to induce realistic patient expectations. Moreover, the study shows that patients with moderately severe allergies, snoring, and sleep apnea (± cpap) usually do not have to expect a worsened sino-nasal health and HRQoL outcome.
Journal Article
Effects of positive airway pressure therapy on quality of life in patients with obstructive sleep apnea syndrome
2025
Objective: Obstructive sleep apnea syndrome (OSAS) significantly impairs the quality of life of affected individuals. This study aimed to assess the health-related quality of life (HRQoL) among patients with mild, moderate, and severe OSAS, and to evaluate differences in HRQoL following a minimum of three months of continuous positive airway pressure (CPAP) therapy. Method: Subjective daytime sleepiness and HRQoL were assessed using standardized questionnaires, including the Epworth Sleepiness Scale (ESS), Fatigue Severity Scale (FSS), Beck Depression Inventory (BDI), Apathy Evaluation Scale (AES), and Montgomery-Asberg Depression Rating Scale (MADRS). Assessments were conducted at the initial visit following an OSAS diagnosis, confirmed through clinical and polysomnographic evaluation. After at least three months of CPAP therapy, the same HRQoL questionnaires were re-administered. The percentage change difference (PCD) for each questionnaire was calculated by comparing baseline scores with those obtained after at least three months of CPAP therapy. Results: A total of 87 patients with OSAS were included in the study. Twenty-seven were female (31%) and 60 were male (69%). Comparison of scale scores before and after CPAP therapy revealed statistically significant reductions across the ESS, BDI, AES, MADRS, and FSS questionnaires (p<0.001). A weak positive correlation was found between the ESS PCD and body mass index, while a moderate negative correlation was observed between the AES PCD and duration of CPAP therapy (p<0.001). Conclusion: Significant improvements in HRQoL were observed following CPAP therapy, regardless of disease severity, gender, presence of comorbid conditions, and smoking status. With the exception of AES scores, these improvements were also independent of the duration of CPAP therapy. Among the HRQoL scales, only AES scores showed a statistically significant reduction after more than six months of CPAP therapy. Keywords: Health-related quality of life, obstructive sleep apnea syndrome, positive airway pressure therapy
Journal Article
Time to health-related quality of life improvement analysis was developed to enhance evaluation of modern anticancer therapies
2020
Major advances have recently been made in the treatments of cancer, which now also have the potential to improve patients’ health-related quality of life (HRQOL). We propose the time to HRQOL improvement (TTI) and the time to sustained HRQOL improvement (TTSI) as potentially important cancer outcomes to be used in longitudinal HRQOL analyses.
As proof of principle, we defined TTI and TTSI, using the Fine–Gray model to include competing risks in estimates, in a case study in real life of a cohort of newly diagnosed patients with cancer receiving a targeted therapy. HRQOL was evaluated before and during therapy with six assessments over a 24-month period, using the well-validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30.
For each assessed HRQOL domain, we assessed TTI and TTSI and estimated the cumulative incidence of patients’ clinically meaningful improvements, also accounting for the occurrence of competing events.
TTI and TTSI are potentially important outcomes in the era of modern anticancer therapies. The analysis of TTI and TTSI by competing risks approach will further add to the statistical methods that can be used to inform on the impact of cancer therapies on patients’ HRQOL.
Journal Article
Attitudes of registered physiotherapists in Israel toward people identifying as lesbian, gay, and bisexual: a cross-sectional survey
2021
Background
This study aimed to explore the attitudes of registered physiotherapists (PTs) in Israel toward people identifying as lesbian, gay, or bisexual (LGB) and to identify background characteristics associated with their attitudes toward LGB individuals.
Methods
This nationwide study in Israel employed an observational design. Participants completed an anonymous online questionnaire which included demographic characteristics (e.g., age, sex, gender, sexual orientation, religious affiliation, and religiousness) and questions regarding sources of knowledge about LGB individuals, and type of acquaintance with an LGB individual. In addition to two self-assessment questions regarding levels of homophobia (active engagement against LGB individuals) and heterosexism (holding negative opinions regarding LGB individuals) answered on a five point Likert scale (1 – not at all homophobic/ heterosexist, 5- very homophobic/ heterosexist) and the Hebrew version of the Attitudes Toward Homosexuality Scale (ATHS). Participants were recruited through professional organizations, social media, and word of mouth.
Results
The data of 383 registered PTs practicing in Israel were analyzed. The median score regarding level of homophobia and heterosexism was one (“not at all”). ATHS scores ranged between 32 and 110 (out of 110), with a median score of 106 and 41% scoring below the median. Multivariant logistic regression indicated that identifying as men, heterosexual orientation, and religiousness were significantly associated with less positive attitudes toward LGB individuals. Only 2% of the participants reported having been introduced to issues regarding the LGB community during their professional physiotherapy education.
Conclusions
Registered PTs in Israel demonstrated favorable attitudes toward LGB individuals, as reflected both by ATHS scores and levels of self-reported homophobia and heterosexism. Based on the current results regarding sources of knowledge, updating the physiotherapy curriculum to include information regarding sexual orientation and health of the LGB community is suggested.
Journal Article