scholarly journals Using patient-reported outcomes to manage postoperative symptoms in patients with lung cancer: protocol for a multicentre, randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e030041
Author(s):  
Wei Dai ◽  
Yuanqiang Zhang ◽  
Wenhong Feng ◽  
Xiaoqing Liao ◽  
Yunfei Mu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Symptom Management ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Intervention Group ◽  
Postoperative Recovery ◽  
Control Group ◽  
Oncological Treatment ◽  
Study Results ◽  
Patient Reported

IntroductionSurgery is one of the primary treatments for lung cancer. The postoperative symptom burden experienced by patients with lung cancer is substantial, seriously delaying their recovery from surgery and impairing their quality of life. Patient-reported outcome (PRO)-based symptom management is increasingly regarded as an optimal model for patient-centred care. Currently, clinical trial-based evidence involving early-phase (immediately after surgery for up to 1 month) symptom management of lung cancer is lacking. We propose a randomised trial to evaluate the effect of a PRO-based symptom-monitoring programme with overthreshold alerts and responses for postoperative recovery in patients with lung cancer.Methods and analysisThe study will recruit 160 patients with lung cancer from six hospitals. The patients will be randomly allocated to the intervention group or control group in a ratio of 1:1. Patients in the intervention group will receive PRO-based symptom management from the specialists when their reported target symptom (pain, coughing, fatigue, disturbed sleep and shortness of breath) scores reach the preset threshold (score ≥4). Patients in the control group will not generate alerts and will follow the standard procedures for symptom management. All patients will receive symptom assessments via the MD Anderson Symptom Inventory—lung cancer module on the day before surgery, daily after surgery and twice a week after discharge until 4 weeks or the start of postoperative oncological treatment. The primary outcome—mean symptom threshold events—will be compared between the intervention and control group via independent sample Student’s t-test.Ethics and disseminationThe study was approved by the Ethics Committee of Sichuan Cancer Hospital on 22 November 2018 (No. SCCHEC-02-2018-045). This manuscript is based on V.2.0, 9 May 2019 of the protocol. The study results will be disseminated in publications in peer-reviewed journals and presentations at academic conferences.Trials registration numberChiCTR1900020846.

scholarly journals Patient-Reported Outcome-Based Symptom Management Versus Usual Care After Lung Cancer Surgery: A Multicenter Randomized Controlled Trial

2022 ◽  
Author(s):  
Wei Dai ◽  
Wenhong Feng ◽  
Yuanqiang Zhang ◽  
Xin Shelley Wang ◽  
Yangjun Liu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Usual Care ◽  
Symptom Management ◽  
Intervention Group ◽  
Lung Cancer Surgery ◽  
Patient Reported Outcome ◽  
Cancer Surgery ◽  
Interquartile Range ◽  
Control Group ◽  
Patient Reported

PURPOSE We aimed to evaluate the efficacy and feasibility of patient-reported outcome (PRO)-based symptom management in the early period after lung cancer surgery. METHODS Before surgery, patients with clinically diagnosed lung cancer were randomly assigned 1:1 to receive postoperative PRO-based symptom management or usual care. All patients reported symptoms on MD Anderson Symptom Inventory-Lung Cancer presurgery, daily postsurgery, and twice a week after discharge for up to 4 weeks via an electronic PRO system. In the intervention group, treating surgeons responded to overthreshold electronic alerts driven by any of the five target symptom scores (score ≥ 4 on a 0-10 scale for pain, fatigue, disturbed sleep, shortness of breath, and coughing). The control group patients received usual care and no alerts were generated. The primary outcome was the number of symptom threshold events (any target symptom with a score of ≥ 4) at discharge. Per-protocol analyses were conducted. RESULTS Of the 166 participants, 83 were randomly allocated to each group. At discharge, the intervention group reported fewer symptom threshold events than the control group (median [interquartile range], 0 [0-2] v 2 [0-3]; P = .007). At 4 weeks postdischarge, this difference was maintained between the intervention and control groups (median [interquartile range], 0 [0-0] v 0 [0-1]; P = .018). The intervention group had a lower complication rate than the control group (21.5% v 40.6%; P = .019). Surgeons spent a median of 3 minutes managing an alert. CONCLUSION PRO-based symptom management after lung cancer surgery showed lower symptom burden and fewer complications than usual care for up to 4 weeks postdischarge.

scholarly journals Optimising symptom management in children with cancer using a novel mobile phone application: protocol for a controlled hybrid effectiveness implementation trial (RESPONSE)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Natalie Bradford ◽  
Paula Condon ◽  
Erin Pitt ◽  
Zephanie Tyack ◽  
Kimberly Alexander
Keyword(s):  
Symptom Management ◽  
Controlled Trial ◽  
Intervention Group ◽  
Symptom Burden ◽  
Control Group ◽  
Children With Cancer ◽  
Randomised Study ◽  
Response System ◽  
Implementation Outcomes ◽  
Patient Reported

Abstract Background Intense and aggressive treatment regimens for most children’s cancer have achieved vast improvements in survival but are also responsible for both a high number and burden of symptoms. The use of Patient Reported Outcome Measures (PROMs) demonstrates a range of benefits for improved symptom management in adults with cancer. There are, however, multiple barriers to integrating PROMs into routine care in children and adolescents with cancer. This study aims to evaluate: (1) the effectiveness of electronic PROMs to generate stratified alerts, symptom management recommendations and graphical summaries (the RESPONSE system) to improve health outcomes and (2) the implementation of the RESPONSE system by assessing feasibility, acceptability, satisfaction, and sustainability. Methods A pragmatic hybrid II effectiveness-implementation controlled trial, using mixed methods, will be undertaken, advancing both knowledge of the effectiveness of the intervention and implementation factors. One-hundred and sixty children with cancer receiving active treatment will be recruited 1:1 to a non-randomised study involving two groups with an equal number of participants in each group. The intervention group (n = 80) will be prospectively recruited to receive the RESPONSE system intervention over eight weeks, versus the historical matched control group (n = 80) who will complete the ePROMs without access to the RESPONSE system. The primary outcome of the effectiveness trial is change between groups in total symptom burden. Secondary outcomes include child health-related quality-of-life and implementation outcomes. Trial data will be analysed using linear mixed-effects models. Formative implementation evaluation is informed by CFIR and ERIC frameworks and implementation outcomes will be mapped to the RE-AIM framework and include interviews, field notes, as well as administrative data to evaluate feasibility, acceptability, satisfaction and sustainability. Trial registration number ACTRN12621001084875. Retrospectively Registered 16 August 2021.

scholarly journals A Non-Randomized Controlled Trial for the Effectiveness of the ‘Aibo’ Intervention Program for Distraction in Childhood Vaccination

2021 ◽  
Author(s):  
Kyoko Tanaka ◽  
Maoko Hayakawa ◽  
Chihiro Noda ◽  
Moemi Nakamura ◽  
Akio Nakamura ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intervention Program ◽  
Controlled Trial ◽  
Intervention Group ◽  
Behavioral Observation ◽  
Childhood Vaccination ◽  
Control Group ◽  
Randomized Controlled ◽  
Study Results ◽  
Face Scale

Abstract Procedures and actions such as injections and immobilization cause pain and distress to children. In the pediatric field, there is a need for interventions and support to alleviate the pain and distress caused by such medical procedures. In recent years, the introduction of robots as a means of distraction has begun to be attempted. In this study, we conducted a non-randomized controlled trial to examine the effect of intervention using ‘aibo’, a dog-like robot which has artificial intelligence (AI), to promote distraction in children after vaccination. As a result, 57 children (32 in the intervention group) participated in the study. Results of a t-test with the control group showed that the intervention group using aibo had significantly less pain following the post-vaccination intervention than the control group using stuffed dog (Face Scale, t(55) = 2.582, p = .0125; Behavioral Observation Scale, t(55) = 2.772, p = .00759). The results support the hypothesis that the aibo intervention group will be less distressed and able to calm down more quickly after vaccination than the control group. Conclusion : AI-powered aibo interventions that allow for interactive interaction can be an effective distraction method during painful procedures such as vaccinations.

scholarly journals Effects of barefoot walking on the flat foot in school going children: A Randomised control trial

2020 ◽  
Vol 11 (SPL4) ◽  
pp. 1805-1812
Author(s):  
Sharath Hullumani V ◽  
Purusotham Chippala
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Randomised Control Trial ◽  
Control Group ◽  
P Value ◽  
Foot And Ankle ◽  
Flat Foot ◽  
Study Results ◽  
Arch Index

Flat foot is also called Plano-valgus foot, and it is a term, that is commonly used in describing flat foot. Some studies have suggested, that certain foot-specific exercises and barefoot weight bear walking can change foot function like flat foot, and also confirm that shoed walking children are more likely to get a flat foot. An Assessor blinded, Randomized controlled trial with thirty-eight children with flat foot aged 6 – 14 years, both male and female were randomised to the control group (n= 19) and intervention group (n=19). The control group had performed barefoot walking for 45 minutes a day for eight weeks, and the intervention group had received foot-specific exercises with barefoot walking for eight weeks. Foot posture was evaluated by the arch index, while the Oxford foot and ankle questionnaire was used to measure the subjective well-being of children. Measurements were taken before and after the eight weeks of intervention. The outcome of the randomised control trial showed that the barefoot walking group faired far better than that which didn't (p-value <0.05). The intervention group outcomes measure Arch Index, and Oxford Foot and Ankle Questionnaire were p-values is <0.05 from seventh and eight weeks. This study results suggest that barefoot walking and specific foot exercises are effective in improving the flat foot in school-going children.

Treatment with and without stabilizing lumbar spinal orthosis after one- or two-level spondylodesis: A randomized controlled trial

2020 ◽  
Vol 28 (5) ◽  
pp. 541-549
Author(s):  
Yorck Rommelspacher ◽  
Hannah Bode ◽  
Jana Ziob ◽  
Charlotte Struwe ◽  
Adnan Kasapovic ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Control Group ◽  
Patient Reported ◽  
Subjective Pain ◽  
Postoperative Mobility ◽  
Lumbar Spinal ◽  
Spinal Orthosis

BACKGROUND AND OBJECTIVE: Musculature affected during spondylodesis surgery may benefit and recover faster if supported by spine orthosis postoperatively. METHODS: This prospective study included 50 consecutive patients undergoing one- or two-level spondylodesis. The intervention group received a lumbar spine orthosis (n= 23), while the control group remained without orthosis (n= 27). Patients were assessed for pain (Visual Analogue Scale, VAS), Oswestry Disability index (ODI) as well as the use of analgesics. RESULTS: Patients wearing an orthosis postoperatively reported a higher degree of subjective stability. However, both intervention as well as control group did not show any significant differences for each of the follow-up points regarding VAS, ODI or the use of analgesics. CONCLUSION: Wearing an orthosis has neither impact on subjective pain, the need for analgesics nor for postoperative functionality. However, patients reported that they profited from wearing the orthosis by feeling more stable, thereby nicely improving their postoperative mobility. Thus, novel patient reported outcome measures have to be developed to assess these features in future studies.

Effect of conversations about values and goals on anxiety in patients.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 9-9 ◽  
Author(s):  
Joanna Paladino ◽  
Rachelle Bernacki ◽  
Mathilde Hutchings ◽  
Stuart R. Lipsitz ◽  
Bridget A. Neville ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Positive Behavior ◽  
Control Group ◽  
Behavior Changes ◽  
Patient Anxiety ◽  
Patient Acceptability ◽  
Serious Illness ◽  
Risk Of Death ◽  
Patient Reported

9 Background: Patients with serious illness routinely receive treatments that do not align with their goals. Earlier clinical conversations about patients’ values and priorities lead to more goal-concordant care and improved quality of life, but clinician concerns about harming patients and taking away hope are barriers to appropriately timed discussions. Methods: A cluster-randomized controlled trial with oncology patients at high risk of death, identified by the surprise question. The intervention included a structured, patient-centered discussion about values and priorities conducted by trained oncology clinicians using the Serious Illness Conversation Guide. Patient anxiety (GAD-7) was measured by survey at baseline and every 2 months; anxiety, patient acceptability, and patient-reported behavior change were measured by survey 1 week after the intervention and at a matching time point for controls. Results: 342 patients enrolled (median age 62y): 176 intervention; 166 control. 102 conversations were completed in the intervention group. The mean anxiety (GAD-7) score prior to the intervention in the intervention group was 3.75 and in the control group was 3.80 (p = 0.72). However, a week after the intervention conversation (on average, the conversation was 10.4 weeks from baseline, IQR 3-13 weeks), there were significant differences. At 11.4 weeks, the intervention anxiety mean was 2.87, and the control mean was 4.26 (p = 0.011). Reductions persisted for 2 months after the conversation. Among patients who had the serious illness conversation and completed the acceptability survey: 86% reported that the conversation was worthwhile; 66% reported positive behavior changes as a result of the discussion; more than 80% reported that their hopefulness, peacefulness, and sense of control over medical decisions increased or did not change. Conclusions: The Serious Illness conversation lowered patient anxiety; this reduction was sustained for at least 2 months after the conversation. Patients viewed the serious illness conversation as worthwhile and reported enacting concrete positive behavior changes as a result of the discussion. Clinical trial information: NCT01786811.

scholarly journals The effectiveness of Kinesio Taping® for mobility and functioning improvement in knee osteoarthritis: a randomized, double-blind, controlled trial

2020 ◽  
Vol 34 (7) ◽  
pp. 877-889 ◽  
Author(s):  
Venta Donec ◽  
Raimondas Kubilius
Keyword(s):  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Outpatient Rehabilitation ◽  
Control Group ◽  
Double Blind ◽  
Kinesio Taping ◽  
Patient Reported ◽  
Double Blinded

Objective: To evaluate the effectiveness of the Kinesio Taping® method for mobility and functioning improvement for patients with knee osteoarthritis (KO). Design: Randomized, double-blinded, controlled trial. Setting: Outpatient rehabilitation department. Subjects: A total of 187 subjects with symptomatic I–III grade KO participated; of these, 157 subjects were included in the analyses (intervention group, n = 81 (123 knees); control group, n = 76 (114 knees). Intervention: The intervention group received a specific Kinesio Taping application, and the control group received non-specific knee taping for a month. Main measures: Changes in Knee injury and Osteoarthritis Outcome Scores (KOOS), knee active range of motion, 10-Meter Walk, and the five times sit to stand tests (5xSST) were assessed at baseline, after four weeks of taping, and a month post taping intervention. Subjective participants’ experiences and opinions on the effect of knee taping were evaluated. The chosen level of significance was p < 0.05. Results: The mean age of participants was 68.7 ± 9.9 in intervention group and 70.6 ± 8.3 in control group ( p > 0.05). The change from baseline in gait speed in the intervention group after taping month was +0.04 ± 0.1 m/s, at follow-up +0.06 ± 0.1 m/s; in control group +0.07 ± 0.1 m/s, and +0.09 ± 0.1 m/s; the change in time needed to accomplish 5xSST was –2.2 ± 3.2 seconds, at follow-up –2.4 ± 3.1 seconds; in control group –2.8 ± 3.6 seconds, and –2.4 ± 4 seconds. Improved knee flexion and enhancement in functioning assessed by KOOS were noticed in both groups, with lasting improvement to follow up. No difference in the change in the above-mentioned outcomes was found between groups ( p > 0.05). Fewer subjects (6.2% (5) vs. 21.1% (16), χ2 = 7.5, df = 2, p = 0.024) from Kinesio Taping group were unsure if taping alleviated their mobility and more intervention group patients indicated higher subjective satisfaction with the effect of knee taping to symptom and mobility alleviation than control group ( p < 0.005). Conclusion: Investigated Kinesio Taping technique did not produce better results in mobility and functioning improvement over non-specific knee taping; however, it had higher patient-reported subjective value for symptom attenuation and experienced mobility enhancement.

PP16 Prehospital recognition and antibiotics for 999 patients with sepsis: feasibility study results

2019 ◽  
Vol 36 (10) ◽  
pp. e8.1-e8
Author(s):  
Jenna Bulger ◽  
Susan Allen ◽  
Jan Davies ◽  
Timothy Driscoll ◽  
Gemma Ellis ◽  
...  
Keyword(s):  
Adverse Events ◽  
Early Recognition ◽  
Randomised Trial ◽  
Intervention Group ◽  
Final Diagnosis ◽  
Outcome Data ◽  
Control Group ◽  
Serious Adverse Events ◽  
Study Results ◽  
The Mean

BackgroundSepsis is a common condition which kills approximately 44,000 people annually in the UK. Early recognition and management of sepsis has been shown to reduce mortality and improve outcomes. Paramedics frequently attend patients with sepsis, and are well placed to provide early diagnosis and treatment. We aimed to assess whether a multi-centre randomised trial to evaluate pre-hospital antibiotics was feasible.MethodsVolunteer paramedics used scratchcards to allocate patients with ‘Red Flag’ Sepsis at random between experimental and control arms. The primary outcome was mortality at six months. We also measured: adverse events, costs, final diagnosis, length of stay in hospital, and quality of care; and collected qualitative data about acceptability to patients in interviews, and paramedics in focus groups. We pre-specified criteria for deciding whether to progress to a fully powered trial based on: recruitment of paramedics and patients; retrieval of outcome data; safety; acceptability; and diagnostic accuracy.ResultsFifty-four paramedics completed their training and were issued scratchcards to randomly allocate patients to trial arms. Patients were recruited from 1.12.17 to 31.5.18. In total, 118 patients were randomly allocated to trial arms; four patients dissented to be included in the trial, leaving 114 patients to follow-up. Sixty-two patients (54%) were allocated to the intervention arm. The mean age of the control arm was 71.2 years (range 28–97); 33 (65%) control participants were female. In the intervention arm the mean age was 75.6 years (range 30–99) and 38 patients (61%) were female. Nine patients in the control group (18%) and 17 in the intervention group (28%) were already taking antibiotics at the time of their 999 call. Twenty-three questionnaires were received. No serious adverse events were reported.ConclusionsComplete results will be presented at the time of the conference, when routine linked anonymised outcomes are available.

scholarly journals Precision-Exercise-Prescription in patients with lung cancer undergoing surgery: rationale and design of the PEP study trial

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e024672 ◽  
Author(s):  
Cornelia M Ulrich ◽  
Caroline Himbert ◽  
Kenneth Boucher ◽  
David W Wetter ◽  
Rachel Hess ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Problem Solving ◽  
Exercise Intervention ◽  
Exercise Prescription ◽  
Controlled Trial ◽  
Clinical Care ◽  
Intervention Group ◽  
Exercise Programme ◽  
Behavioural Treatment ◽  
Patient Reported

IntroductionLung cancer is a significant burden on societies worldwide, and the most common cause of death in patients with cancer overall. Exercise intervention studies in patients with lung cancer have consistently shown benefits with respect to physical and emotional functioning. However, to date, exercise training has not been consistently implemented into clinical practice given that interventions have been costly and not aligned with clinical care.Methods/designThe Precision-Exercise-Prescription (PEP) study is a prospective randomised controlled trial comparing the effectiveness and feasibility of a personalised intervention exercise programme among patients with lung cancer undergoing surgery. Two-hundred patients who are diagnosed with stage primary or secondary lung cancer and are eligible to undergo surgical treatment at Huntsman Cancer Institute comprise the target population. Patients are randomised to either the (1) outpatient precision-exercise intervention group or (2) delayed intervention group. The intervention approach uses Motivation and Problem Solving, a hybrid behavioural treatment based on motivational interviewing and practical problem solving. The dosage of the exercise intervention is personalised based on the individual’s Activity Measure for Post-Acute-Care outpatient basic mobility score, and incorporates four exercise modes: mobility, callisthenics, aerobic and resistance. Exercise is implemented by physical therapists at study visits from presurgery until 6 months postsurgery. The primary endpoint is the level of physical function assessed by 6 min walk distance at 2 months postsurgery. Secondary outcomes include patient-reported outcomes (eg, quality of life, fatigue and self-efficacy) and other clinical outcomes, including length of stay, complications, readmission, pulmonary function and treatment-related costs up to 6 months postsurgery.Ethics/disseminationThe PEP study will test the clinical effectiveness and feasibility of a personalised exercise intervention in patients with lung cancer undergoing surgery. Outcomes of this clinical trial will be presented at national and international conferences and symposia and will be published in international, peer-reviewed journals. Ethics approval was obtained at the University of Utah (IRB 00104671).Trial registration numberNCT03306992.

scholarly journals Effect of Leg Length–Evening Device on Perceived Balance in Patients Wearing a Controlled Ankle Motion Boot

2020 ◽  
Vol 5 (3) ◽  
pp. 247301142093023
Author(s):  
Nasima Mehraban ◽  
Alexander J. Idarraga ◽  
Kevin J. Wu ◽  
Milap S. Patel ◽  
Anand M. Vora ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Leg Length ◽  
Ankle Motion ◽  
Plantar Aspect ◽  
Total Pain ◽  
Multicenter Randomized Controlled Trial ◽  
Patient Reported

Background: Patients are often made weightbearing as tolerated (WBAT) in a controlled ankle motion (CAM) boot for the management of various foot and ankle conditions. The CAM boot causes a leg length discrepancy (LLD) between the booted (longer) and contralateral (shorter) lower extremities. This discrepancy can potentially cause balance problems, undue strain on joints, and discomfort in patients. We hypothesized that a leg length–evening orthotic placed on the plantar aspect of the contralateral shoe improves balance among patients who are WBAT in a CAM boot. Methods: Patients made WBAT in a CAM boot were randomized to either the leg length–evening orthotic intervention group or to a control group in which patients wore a normal shoe of their choice. Patients were followed for 2 weeks and asked a series of questions pertaining to balance and pain experienced at their knees, hips, and back. Balance was the primary outcome and was scored from 0 (no difficulty with balance) to 10 (great difficulty with balance). Of 107 subjects enrolled and randomized, 95 (88.8%) completed the study, satisfying the a priori sample size requirement of 94 patients. There were no differences in baseline characteristics between groups ( P > .05 for each). Results: Intervention patients reported less difficulty with balance than control patients (intention-to-treat analysis: 2.0±1.5 vs 3.2±1.8, P = .001; as-treated analysis: 2.1±1.7 vs 3.0±1.7, P = .009). Intervention and control patients did not differ with respect to pain experienced at their knees, hips, or back, or in a composite total pain score ( P > .05 for each). Conclusion: This multicenter randomized controlled trial found that adding a limb length–evening orthotic to the plantar aspect of the contralateral shoe in a patient that is WBAT in a CAM boot improved patient-reported self-assessment of balance. The trial was powered to identify a difference in the primary outcome measure of balance and may have been insufficiently powered to identify differences in knee, hip, back, or total pain. Level of Evidence: Level II, prospective comparative study.

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