Data Acquisition for Assessment of Medical Technology: Methods Other than Technical Trials

Author(s):  
Lincoln E. Moses

The term “assessment of medical technologies” does not appear to have a unique meaning that always applies to its use. It seems wise, then, to state what will be meant by the term in this chapter. “Medical technology” is regarded here as including drugs, devices, procedures, (whether preventive, diagnostic, or therapeutic) that bear more or less directly on patients. Thus, an educational program for patients might be a technology, but a training program for dietitians would not. A surgical procedure or a prosthesis would; but a scale for assessing quality of life would not. “Assessment,” as used here, refers to a complex set of activities that comprise data acquisition, analysis, and interpretation concerning properties of medical technologies. Assessment tends to be comparative, either explicitly (as to a control group) or implicitly (as looking toward “usual experience”). In any case, the goal of assessment is to increase understanding of such properties of a medical technology as its applicability, convenience, efficacy, safety, effectiveness, cost, etc.

Author(s):  
Francisco Javier Amarilla-Donoso ◽  
Raúl Roncero-Martín ◽  
Jesus Lavado-García ◽  
María de la Luz Canal-Macías ◽  
María Pedrera-Canal ◽  
...  

The objective of this study was to determine the impact of a postoperative educational intervention program on the health-related quality of life (HRQoL) of patients with hip fracture using a controlled clinical trial in a randomized, multicenter study. In total, 102 patients (45.5%) from trauma units at the two University Hospitals of the province of Cáceres received the educational program, whereas 122 (54.5%) did not. Patients were consecutively included in either an intervention or a control group. Patients from the intervention group received an educational program during admission and the postoperative period. Patients from the control group did not receive any educational program. These patients were managed according to routine protocols. The patients were predominantly female (76.3%), aged 84.6 years (SD 6.1). All dimensions in both groups at 12 months showed a significant decrease with respect to baseline, except for bodily pain in both groups (p = 0.447; p = 0.827) and social functioning in the intervention group (p = 0.268). Patients receiving the educational program showed higher levels in the dimensions of the Mental Component Summary (MCS-12) (p = 0.043), vitality (p = 0.010), and social functioning (p < 0.001), as well as in the dimensions of the SF-12 health survey questionnaire of HRQoL 12 months after surgery. In conclusion, our study of the intervention group showed that there were significant improvements in MCS-12, vitality, and social function dimensions compared to the control group.


2019 ◽  
Vol 40 (02) ◽  
pp. 116-124 ◽  
Author(s):  
Jose Jiménez-García ◽  
Antonio Martínez-Amat ◽  
M. De la Torre-Cruz ◽  
Raquel Fábrega-Cuadros ◽  
David Cruz-Díaz ◽  
...  

AbstractThis study aimed to evaluate the effects of a 12-week high-intensity interval exercise (HIIT) training program involving suspension exercises (TRX) on the muscle strength, body composition, gait speed, and quality of life of older adults. A total of 82 older adults were randomly assigned to 3 groups: a HIIT group (n=28), a continuous intensity training group (MIIT group, n=27), or a control group (CG, n=27). Compared to MIIT and CG, participants of the HIIT group showed significant post-intervention improvements in BMI (p=.002 and p<.001, respectively) and gait speed (p<.001 for both). Handgrip strength increase was also observed after HIIT (p=.002), but no differences were observed with MIIT and CG. Compared with MIIT and control groups, HIIT showed improvements in the SF-36 domains: general health (p<.001 for both) health changes (p<.001 for both), vitality (p=.002 and p=.001 respectively) and physical functioning (p=.036 and p<.001 respectively). Our results suggest that a HIIT training program with TRX have benefits in BMI, handgrip strength, gait speed, and quality of life in older adults.


2013 ◽  
Vol 28 (3) ◽  
pp. 199-206 ◽  
Author(s):  
Laurien Aben ◽  
Majanka H. Heijenbrok-Kal ◽  
Rudolf W. H. M. Ponds ◽  
Jan J. V. Busschbach ◽  
Gerard M. Ribbers

Background and purpose. This study aims to determine the long-term effects of a new Memory Self-efficacy (MSE) training program for stroke patients on MSE, depression, and quality of life. Methods. In a randomized controlled trial, patients were allocated to a MSE training or a peer support group. Outcome measures were MSE, depression, and quality of life, measured with the Metamemory-In-Adulthood questionnaire, Center for Epidemiological Studies–Depression Scale (CES-D), and the Who-Qol Bref questionnaire, respectively. We used linear mixed models to compare the outcomes of both groups immediately after training, after 6 months, and after 12 months, adjusted for baseline. Results. In total, 153 former inpatients from 2 rehabilitation centers were randomized—77 to the experimental and 76 to the control group. MSE increased significantly more in the experimental group and remained significantly higher than in the control group after 6 and 12 months (B = 0.42; P = .010). Psychological quality of life also increased more in the experimental group but not significantly (B = 0.09; P = .077). However, in the younger subgroup of patients (<65 years old), psychological quality of life significantly improved in the experimental group compared to the control group and remained significantly higher over time (B = 0.14; P = .030). Other outcome measures were not significantly different between both groups. Conclusions. An MSE training program improved MSE and psychological quality of life in stroke patients aged <65 years. These effects persisted during 12 months of follow-up.


Author(s):  
Adizova D.R. ◽  

To study the effectiveness of teaching "self-care" and "self-control" in elderly and senile patients with chronic heart failure. The study included 107 patients with chronic heart failure. The training program was attended by 54 patients who made up the study group. 53 untrained patients made up the control group. These sessions were conducted with patients for 7 days, 1 hour per day. To assess the effectiveness of the training program, adherence to treatment was assessed using the Morisky-Green scale and the quality of life was assessed using the Minnesota questionnaire on the quality of life of patients. Results. During 1 year of follow-up, feedback was interrupted with 17 patients (15,8%) due to various reasons. Out of 90 subjects of observation, only 6 patients (6,7%) died due to the deterioration of their condition and the development of associated conditions. The assessment of the number of visits by patients to family polyclinics showed a generally satisfactory level of clinical examination in the study group - the average rate of planned visits was 3,2. In the control group, the average number of visits was 2,5 per year. There was a statistically significantly lower number of unplanned visits to the study group compared to patients from the control group. As a result, there was a significant decrease in the number of unplanned visits in the intervention group as a whole. Conclusion. The program of training elderly and senile patients on the aspects of self-medication and self-control in chronic heart failure is effective in improving the control of their adherence to therapy and the prognosis of the disease.


2019 ◽  
Vol 8 (2) ◽  
pp. 89-93 ◽  
Author(s):  
Ali Sadeghi Akbari ◽  
Mohammad Ali Cheraghi ◽  
Anoushiravan kazemnejad ◽  
Mahin Nomali ◽  
Maasumeh Zakerimoghadam

Introduction: Because of the chronic nature of Heart Failure (HF), low Quality of Life (QoL) and poor self-care are prevalent among patients with HF. Thus, the aim of this study was to evaluate the effect of illness perception correction- based educational program on QoL,and self- care in patients with HF. Methods: In this randomized controlled trial, 78 eligible patients were included in the study from Rajaei Heart Center (Tehran, Iran) and randomly assigned into intervention and control group with 1:1 allocation ratio. The intervention was a combination of illness perception correction- based education program (30- minute sessions over 3 consecutive days) and 10-minute phone calls made once a week in the course of 8 weeks. The control group received usual care. The primary outcome was quality of life and secondary outcomes were self- care and illness- perception which were measured at baseline and at the end of the study. SPSS version 13 was used for the analysis. Results: Out of 76 eligible patients, 70 patients with HF finished the study. Although the mean of quality of life, self-care, and illness perception were not different at baseline, QoL (45.2 (8.3) VS 66.8 (15.4); P<0.001), self-care (18.5 (4.5) VS 37.1 (7.2); P<0.001), and illness- perception (183.6 (8.4) VS 151.2 (24.5); P<0.001) improved following the program in the intervention group in comparison to the control group. Conclusion: According to the study findings, this program can be applied by nurses for patients with HF as a discharge plan in order to improve their QoL, self-care, and their illness perception.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
H Rymuza ◽  
R Dabrowski ◽  
N Krauze ◽  
I Kowalik ◽  
E Smolis-Bak ◽  
...  

Abstract Background The population of elderly patients after acute coronary syndrome (ACS) is increasing due to the extension of life expectancy. Purpose The aim of the study was to demonstrate the impact of individual exercise training on the course of the disease, exercise tolerance and quality of life in patients over 75 years of age after ACS. Methods The randomized, prospective, controlled clinical trial included patients with ACS, age >75 years, after acute percutaneous coronary interventions (PCI). Patients were randomly assigned to two groups: a training group (ExT) subjected to individualized physical training and a control group, not subjected to training program (CG). ExT patients participated in trainings three times a week for 2 months according to model B or C of the second stage of rehabilitation. Patients from control group (CG) received general recommendations for activity. In addition, patients underwent exercise tolerance test (ETT), 6-minute walk tests (6-MWT), NHP questionnaires evaluation, laboratory tests, ECG, echocardiographic examinations. Results The study included 51 patients, mean age 80 years, men: 50%, n=25 ExT, n=26 (CG). The study was completed by all patients. Physical capacity at the beginning of the trainings assessed in ETT and 6-MWT was comparable in both groups, ns. After two months of training program the average ETT exercise time increased by 12.5% (from 416±152 to 468±153 sec, p=0.0114), and the load by 13% (69±5.2 WAT to 78±25.4 WAT, p=0.0005). The average distance in 6-MWT increased by 8.3% (446±90 to 483±60 m, p=0.006). In CG, the values of the ETT and 6-MWT parameters hadn't significantly changed. After trainings cessation, the mean distances in the study after 6 months and after 12 months returned to the initial values of 474±73 and 476±80 m (respectively: p=0.069, p=0.062) in comparison to the test performed before the beginning of rehabilitation. Similarly, after 1 year, the average duration of the exercise test (242±147 sec) and the average load obtained (70±22.4 WAT) decreased significantly compared to the results after rehabilitation (p=0.0009, p=0.0006), obtaining similar levels as in the initial tests (p=0.481, p=0.593). In the NHP questionnaire in the ExT group the level of pain was significantly lower after the end of the training with respect to the initial measurements (p=0.007) and after 12-months follow-up (p=0.029). In the scale of emotional reactions, a significant deterioration of the quality of life in the ExT group was found after 12 months in relation to measurements after rehabilitation (p=0.040). Conclusions In the octogenarians after ACS, cardiac rehabilitation is safe and in a short period of time improves physical performance. The cessation of the 2-month training results in loss of achieved effects and the deterioration of the quality of life after 12 months since ACS.


2016 ◽  
Vol 15 (4) ◽  
pp. 434-443 ◽  
Author(s):  
Grace Meijuan Yang ◽  
Yung Ying Tan ◽  
Yin Bun Cheung ◽  
Weng Kit Lye ◽  
Sock Hui Amy Lim ◽  
...  

ABSTRACTObjective:Physicians and nurses do not assess spirituality routinely, even though spiritual care is a vital part of palliative care for patients with an advanced serious illness. The aim of our study was to determine whether a training program for healthcare professionals on spirituality and the taking of a spiritual history would result in improved patient quality of life (QoL) and spiritual well-being.Method:This was a cluster-controlled trial of a spiritual care training program for palliative care doctors and nurses. Three of seven clinical teams (clusters) received the intervention, while the other four served as controls. Included patients were newly referred to the palliative care service, had an estimated survival of more than one month, and were aware of their diagnosis and prognosis. The primary outcome measure was the Functional Assessment of Chronic Illness Therapy–Spiritual Well-Being (FACIT–Sp) patient-reported questionnaire, which patients completed at two timepoints. Total FACIT–Sp score includes the Functional Assessment of Cancer Therapy–General (FACT–G) questionnaire, which measures overall quality of life, as well as a spiritual well-being score.Results:Some 144 patients completed the FACIT–Sp at both timepoints—74 in the control group and 70 in the intervention group. The change in overall quality of life, measured by change in FACT–G scores, was 3.89 points (95% confidence interval [CI95%] = –0.42 to 8.19, p = 0.076) higher in the intervention group than in the control group. The difference between the intervention and control groups in terms of change in spiritual well-being was 0.32 (CI95% = –2.23 to 2.88, p = 0.804).Significance of results:A brief spiritual care training program can possibly help bring about enhanced improvement of global patient QoL, but the effect on patients' spiritual well-being was not as evident in our participants. Further study with larger sample sizes is needed to allow for more definite conclusions to be drawn.


GYMNASIUM ◽  
2020 ◽  
Vol XXI (1) ◽  
pp. 50
Author(s):  
Iulian Ștefan HOLUBIAC ◽  
Vlad Teodor GROSU

The impact of a resistance training program on improving the quality of life is not well established. The present study aimed to evaluate the effects of 12-month resistance training in quality of life in women with postmenopausal osteoporosis or osteopenia. Ten women with postmenopausal osteopenia/osteoporosis were divided into a exercise group and control group. The training program included exercises for upper and lower limb muscles with intensities of 50 –70% of 1RM over a period of 12 months. The quality of life was evaluated before and at the end of the study using the Quality of life questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41). A significant improvement was noted in the quality of life in four of the seven parameters for exercise group compared to control group: pain, social activities, general health and mental function. Resistance training program for women with postmenopausal osteopenia/osteoporosis provides quality of life improvement.


2020 ◽  
Vol 29 (8) ◽  
pp. 616-626
Author(s):  
Ilkay Culha ◽  
Elif Gursoy ◽  
Hulya Bulut

This study aimed to investigate the effect of a discharge training program structured according to the Roy adaptation model (RAM) on patient outcomes (quality of life, coping-adaptation, self-esteem) following gynecologic oncology surgery. This nonrandomized intervention studies consisted of two stages. In the first stage, patients were interviewed, patient needs after discharges were determined. Interview data were analyzed, and RAM-based training booklet was prepared. This booklet was prepared in line with a number of themes. In the second stage, the study was conducted with a sample of 36 control and 36 intervention patients, who were included in the discharge training program. Data was collected preoperatively, at 9th and 13th weeks after discharge. The mean quality of life and coping/adaptation scores of the intervention group at 13th weeks were significantly higher than those of the control group, however, no significant difference was found between the groups in terms of mean self-esteem scores.


2005 ◽  
Vol 23 (10) ◽  
pp. 2378-2388 ◽  
Author(s):  
Lene Thorsen ◽  
Eva Skovlund ◽  
Sigmund B. Strømme ◽  
Kjersti Hornslien ◽  
Alv A. Dahl ◽  
...  

Purpose To evaluate the effectiveness of a supervised home-based flexible training program on cardiorespiratory fitness (CRF), mental distress, and health-related quality of life (HRQOL) parameters in young and middle-aged cancer patients shortly after curative chemotherapy. Patients and Methods One hundred eleven patients age 18 to 50 years who had received chemotherapy for lymphomas or breast, gynecologic, or testicular cancer completed the trial. These patients were randomly allocated to either an intervention group (n = 59), which underwent a 14-week training program, or a control group (n = 52) that received standard care. Primary outcome was change in CRF, as determined by Åstrand-Rhyming indirect bicycle ergometer test (maximum oxygen uptake [VO2max]), between baseline (T0) and follow-up (T1). Secondary outcomes were mental distress, as assessed by the Hospital Anxiety and Depression Scale, and HRQOL, as assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire. Two-way analysis of covariance was used to analyze changes from T0 to T1. Results VO2max increased by 6.4 mL/kg–1/min–1 in patients in the intervention group and by 3.1 mL/kg–1/min–1 in patients in the control group (P < .01). The fatigue score decreased by 17.0 points in the control group compared with only 5.8 points in the intervention group (P < .01). There were no intergroup differences in mental distress or HRQOL. Conclusion A supervised, home-based, flexible training program has significant effect on CRF in young and middle-aged cancer patients shortly after curative chemotherapy, but it has no favorable effect on patients' experience of fatigue, mental distress, or HRQOL.


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