Related Articles

Context

Spinal cord injury and/or disorders (SCI/D) is a costly chronic condition. Impaired mobility, and lengthy travel distances to access specialty providers are barriers that can have adverse impact on expenses and quality of care. Although ample opportunities for use of telehealth technologies exist between medical facilities, and from clinical to home settings, field experience has largely been focused on home telehealth services to promote better patient self-management skills and improve clinical outcomes.

Findings

This paper provides an overview of published literature on use of telehealth technologies with the SCI/D population. Presentation of case studies describe telehealth as a potential strategy for addressing disparities in providing quality care, and explore comprehensive management of multiple health issues in individuals with SCI/D. Experiences of providers in both private sector health-care systems and VHA medical facilities are described. Development of telehealth clinical protocols and adaptive devices that can be integrated with equipment to accommodate for the functional limitations in the SCI/D population are discussed as necessary for expansion of use of telehealth services. Rigorous research studies are lacking. As use of this technology spreads and issues surrounding implementation are addressed, we look forward to increased research to assess and evaluate its efficacy in the SCI/D population.

Conclusion/clinical relevance

Telehealth in the home setting appears to be able to help persons with SCI/D remain in the community. As the use of telehealth increases, research will be necessary in both clinical and home settings to assess its efficacy in improving outcomes in the SCI/D population.

The National Spinal Cord Injury Statistical Center data base contains information collected prospectively on 13,763 persons injured since 1973 and treated at model systems of care throughout the United States. These data clearly demonstrate improved neurologic status and independent function in activities of daily living following acute care and rehabilitation for most persons with spinal cord injuries. Decreased lengths of initial and subsequent hospital stays and increased survival rates are also documented. Most persons are discharged to a private residence in the community and remain there. Many complete their educations and return to gainful employment after injury. Spinal cord injury has only a short-term effect on marriage and divorce rates, which appears to dissipate within a few years after injury. Overall, these figures demonstrate the dramatic improvements in length and quality of life achieved by most persons with spinal cord injuries during the past two decades.

Although there is consensus that parents should be involved in interventions designed for young children with autism spectrum disorder (ASD), parent participation alone does not ensure consistent, generalized gains in children's development. Barriers such as costly intervention, time-intensive sessions, and family life may prevent parents from using the intervention at home. Telehealth integrates communication technologies to provide health-related services at a distance. A 12 one-hour per week parent intervention program was tested using telehealth delivery with nine families with ASD. The goal was to examine its feasibility and acceptance for promoting child learning throughout families' daily play and caretaking interactions at home. Parents became skilled at using teachable moments to promote children's spontaneous language and imitation skills and were pleased with the support and ease of telehealth learning. Preliminary results suggest the potential of technology for helping parents understand and use early intervention practices more often in their daily interactions with children.

Background:

The spinal cord injured patients if congregated early in spinal units where better facilities and dedicated expert care exist the outcome of treatment and rehabilitation, can be improved. The objective of this study is to find out the various factors responsible for a delay in the presentation of spinal injury patients to the specialized spinal trauma units and to suggest steps to improve the quality of care of the spinal trauma patients in the Indian setup.

Materials and Methods:

Sixty patients of traumatic spinal cord injury admitted for rehabilitation between August 2005 and May 2006 were enrolled into the study and their data was analyzed.

Results:

Eighty-five per cent of the spinal cord injured patients were males and the mean age was 34 years (range 13-56 years). Twenty-nine (48.33%) of the spinal injuries occurred due to fall from height. There was an average of 45 days (range 0-188 days) of delay in presentation to a specialized spinal unit and most of the time the cause for the delay was unawareness on the part of patients and/or doctors regarding specialized spinal units. In 38 (62.5%) cases the mode of transportation of the spinal cord injured patient to the first visited hospital was by their own conveyance and the attendants of the patients did not have any idea about precautions essential to prevent neurological deterioration. Seventeen (28.33%) patients were given injection solumedrol with conservative treatment, 35 (60%) patients were given only conservative treatment and seven patients were operated (11.66%) upon at initially visited hospital. Of the seven patients operated five were fixed with posterior Harrington instrumentation (71.42%) and two (28.57%) were operated by short segment posterior pedicle screw fixation. None of the patients were subjected to physiotherapy-assisted transfers or wheel chair skills or even basic postural training, proper bladder/ bowel training program and sitting balance.

Conclusion:

Awareness on the part of the general population, attendants of the patients, clinical and paraclinical team regarding spinal cord injury needs to be addressed. Safe mode of transportation of spinal cord injured patient and early presentation at tertiary spinal care center with comprehensive spinal trauma care team should be stressed upon.

Study Design

A systematic review.

Objective

To critically review quality of life (QOL) instruments used with spinal cord injury (SCI) populations.

Setting

Vancouver, Canada

Methods

A systematic literature review was conducted for publications assessing the measurement properties of QOL outcome measures. Pre-established criteria were used to evaluate the measurement properties.

Results

Fourteen articles reporting on 13 QOL instruments met the inclusion criteria, including the PRISM, QWB, Qualiveen, SIP68, SF-36, SF-36V, SF-12, SF-6D, QLI, QOLP-PD, SWLS, SWBI, and the WHOQOL-BREF. The SF-36 and WHOQOL-BREF have been widely used and validated. The SIP68, QOLP-PD, SF-36V and SWBI are promising with limited investigation. The Qualiveen and PRISM performed well, and are specific to SCI complications.

Conclusion

The WHOQOL-BREF, is presently the most acceptable and established instrument to assess quality of life after spinal cord injury. The SIP68, QOLP-PD, SF-36V and SWBI are promising, however, require further evaluation of their measurement properties..

Purpose

To estimate readability of seven commonly used health-related quality of life instruments: SF-36, HUI, EQ-5D, QWB-SA, HALex, Minnesota Living with Heart Failure Questionnaire (MLHFQ), and the NEI-VFQ-25.

Methods

The Flesch–Kincaid (F–K) and Flesch Reading Ease (FRE) formulae were used to estimate readability for every item in each measure.

Results

The percentage of items that require more than 5 years of formal schooling according to F–K was 50 for the EQ-5D, 53 for the SF-36, 80 for the VFQ-25, 85 for the QWB-SA, 100 for the HUI, HALex, and the MLHFQ. The percentage of items deemed harder than “easy” according to FRE was 50 for the SF-36, 67 for the EQ-5D, 79 for the QWB-SA, 80 for the VFQ-25, 100 for the HUI, HALex, and the MLHFQ.

Conclusions

All seven surveys have a substantial number of items with high readability levels that may not be appropriate for the general population.

Objective

Determine the effects of body-weight-supported treadmill training (BWSTT) and tilt-table standing (TTS) on clinically assessed and self-reported spasticity, motor neuron excitability, and related constructs in individuals with chronic spinal cord injury (SCI).

Design

Random cross-over.

Methods

Seven individuals with chronic SCI and spasticity performed thrice-weekly BWSTT for 4 weeks and thrice-weekly TTS for 4 weeks, separated by a 4-week wash-out. Clinical (Modified Ashworth Scale, Spinal Cord Assessment Tool for Spinal reflexes) and self-report (Spinal Cord Injury Spasticity Evaluation Tool, Penn Spasm Frequency Scale) assessments of spasticity, quality of life (Quality of Life Index Spinal Cord Injury Version – III), functional mobility (FIM Motor Subscale), plus soleus H-reflex were measured at baseline, after the first training session and within 2 days of completing each training condition.

Results

In comparison with TTS, a single session of BWSTT had greater beneficial effects for muscle tone (effect size (ES) = 0.69), flexor spasms (ES = 0.57), and the H/M ratio (ES = 0.50). Similarly, flexor spasms (ES = 0.79), clonus (ES = 0.66), and self-reported mobility (ES = 1.27) tended to benefit more from 4 weeks of BWSTT than of TTS. Participation in BWSTT also appeared to be favorable for quality of life (ES = 0.50). In contrast, extensor spasms were reduced to a greater degree with TTS (ES = 0.68 for single session; ES = 1.32 after 4 weeks).

Conclusion

While both BWSTT and TTS may provide specific benefits with respect to spasticity characteristics, data from this pilot study suggest that BWSTT may result in a broader range of positive outcomes.

Purpose

To compare three preference-based health-related quality-of-life (HRQL) measures and examine independent correlates of HRQL among overweight and obese women with urinary incontinence (UI) enrolled in a weight loss intervention trial.

Methods

Participants completed baseline questionnaires, which included the Health Utilities Index 3 (HUI3) and Medical Outcomes Study Short Form-36 (SF-36). The SF-36 was used to derive SF-6D and estimated Quality of Well-Being (eQWB) scores. Height, weight, medical history, incontinence measures, and level of physical activity also were assessed. The intraclass correlation coefficient (ICC) was computed, and differences in mean scores across HRQL measures were examined. Potential correlates of HUI3, SF-6D, and eQWB scores were evaluated using multivariable generalized linear models.

Results

Mean ± SD scores for the HUI3, SF-6D, and eQWB were 0.81 ± 0.18, 0.75 ± 0.10, and 0.71 ± 0.06, respectively. Significant differences were observed across measures (P < 0.0001), and the overall ICC was 0.36. In multivariable analyses, BMI was negatively associated with HUI3 (P = 0.003) and eQWB (P < 0.001), and UI episode frequency was negatively associated with eQWB (P = 0.015) and SF-6D (P < 0.001).

Conclusions

Significant differences in mean utilities across the HUI3, SF-6D, and eQWB indicate that these measures do not assess identical dimensions of HRQL. Both BMI and UI episode frequency were related to HRQL in this cohort; however, the magnitude of the relationship depended on the preference-based measure used. These findings highlight the need to consider the method used to generate HRQL values for calculating quality-adjusted life-years in cost-utility analyses, since choice of method may have a substantial impact on the outcome of the analysis.

Background/Objective:

To examine and compare demographics and functional outcomes for individuals with spinal cord injury (SCI) clinical syndromes, including central cord (CCS), Brown-Sequard (BSS), anterior cord (ACS), posterior cord (PCS), cauda equina (CES), and conus medullaris (CMS).

Design:

Retrospective review.

Setting:

Tertiary care, level 1 trauma center inpatient rehabilitation unit.

Participants:

Eight hundred thirty-nine consecutive admissions with acute SCIs.

Main Outcomes Measures:

Functional independence measure (FIM), FIM subgroups (motor, self-care, sphincter control), length of stay (LOS), and discharge disposition.

Results:

One hundred seventy-five patients (20.9%) were diagnosed with SCI clinical syndromes. CCS was the most common (44.0%), followed by CES (25.1%) and BSS (17.1%). Significant differences (P ≤ 0.01) were found between groups with regard to age, race, etiology, total admission FIM, motor admission FIM, self-care admission and discharge FIM, and LOS. Statistical analysis between tetraplegic BSS and CCS revealed significant differences (P ≤ 0.01) with respect to age (39.7 vs 53.2 years) and a trend toward significance (P ≤ 0.05) with regard to self-care admission and discharge FIM. No significant differences (P ≤ 0.01) were found when comparing CMS to CES.

Conclusions:

SCI clinical syndromes represent a significant proportion of admissions to acute SCI rehabilitation, with CCS presenting most commonly and representing the oldest age group with the lowest admission functional level of all SCI clinical syndromes. Patients with cervical BSS seem to achieve higher functional improvement by discharge compared with patients with CCS. Patients with CMS and CES exhibit similar functional outcomes. Patients with ACS and PCS show functional gains with inpatient rehabilitation, with patients with ACS displaying the longest LOS of the SCI clinical syndromes. These findings have important implications for the overall management and outcome of patients with SCI.

The Spinal Cord Injury Rehabilitation Evidence (SCIRE) is a synthesis of the research evidence underlying rehabilitation interventions to improve the health of people living with SCI. SCIRE covers a comprehensive set of topics and in this issue we present six papers relevant to SCI rehabilitation clinicians (SCI inpatient rehabilitation practices, gait strategies, upper extremity reconstructive surgery, spasticity treatments, cardiovascular health and bone health). The SCIRE used a systematic and well-defined protocol to assess and synthesize the evidence. Each article was scored for its methodological quality using either the Physiotherapy Evidence Database (PEDro) Score for randomized controlled trials or the Downs and Black Tool for other types of studies. Following the individual study assessment, conclusions were drawn about the accumulated studies for each topic of interest based on the levels of evidence, quality of studies and concurring evidence. The SCIRE project was designed for health professionals to inform them of best practices.

Study Design

Prospective, correlational

Objectives

1) describe how pain changes over recovery from admission to spinal cord injury (SCI) rehabilitation, discharge and after 6 months of community living and 2) examine the relationship between pain and community integration at 6 months of community living.

Setting

Tertiary rehabilitation centre, spinal cord injury unit, Vancouver, Canada.

Methods

Subjects from 66 consecutive admissions to the Spinal Cord Injury Program of a tertiary rehabilitation centre for the treatment of a traumatic spinal cord injury during the years 2000 to 2002 were followed using data from the National Rehabilitation Reporting System (NRRS). Information was obtained from NRRS standardized assessments performed on admission, discharge and 6 month community living. Early community living was defined as 6-months post-discharge. Community re-integration was assessed by the Reintegration to Normal Living Index (RNL). Pain presence, pain impact and pain intensity were assessed using single item Likhert type scales.

Results

86% of individuals with a SCI reported pain at 6-months post discharge, with 27% of these individuals reporting pain that impacted on many or most activities. Pain impact and pain intensity were related to the community re-integration (r=−0.39 and r=−0.55, p<.001), with pain intensity accounting for 25% of the variance in RNL scores.

Conclusions

Pain is a major consequence of a SCI, impacting on an individual’s activities and perception of how well they are integrated into the community. The results of this study highlight the need to address pain during both the rehabilitation phase of treatment and the early transition into the community.

Study design:

Interview survey.

Objective:

To assess depression in adults with pediatric-onset spinal cord injuries (SCI) and to determine demographic and injury-related factors, and outcomes associated with depression, and to determine which other outcomes are associated with depression.

Methods:

Subjects were adults with pediatric-onset SCI who sustained SCI at age ≤18 years and were interviewed at age ≥24 years. This is part of a longitudinal study for which there were 864 eligible participants; 353 (41%) were interviewed. Of these, 232 were assessed for depression. A telephone interview was conducted that included a structured questionnaire and standardized measures (Functional Independence Measure, Craig Handicap Assessment and Reporting Technique, Short-Form 12 measure of health-related quality of life, Satisfaction with Life Scale, and Patient Health Questionnaire-9 to screen for depression).

Results:

Twenty-seven percent reported depressive symptoms ranging from mild to severe, and 7% reported having suicidal thoughts within the last 2 weeks, and 3% reported symptoms consistent with probable major depressive disorder (MDD). Depression was not significantly associated with any demographic factors but it was associated with incomplete injury (P = 0.013). Depression was also associated with many participation outcomes, health-related quality of life, life satisfaction, and medical complications.

Conclusions:

Depression is a significant problem among adults with pediatric-onset SCI and is associated with poorer outcomes and lower quality of life. These findings should be addressed as clinicians prepare children and adolescents with SCI to transition to adulthood.

Peripheral tissue injury as well as spinal cord injury (SCI) may lead to sensitization of dorsal horn neurons and alterations in nociceptive processing. Thus, peripheral injuries experienced by SCI patients, even if not initially perceived, could result in a persistent and widespread activation of dorsal horn neurons and emerge as chronic pain with interventive repair or modest recovery from SCI. To visualize the spinal neuron response to peripheral tissue injury following complete SCI in rats, the neural transcription factor Fos was quantitated in the spinal cord. Two weeks following either a complete transection of the spinal cord at the level of T8 or a sham surgery (laminectomy), rats were injected with formalin into the left hind paw. Sham-operated rats demonstrated biphasic hind paw pain-related behavior following formalin injection, but transected rats displayed fewer behaviors in the second (tonic) phase. Stereological analysis of the sham group revealed that the extent of formalin-induced Fos expression was within the lumbar dorsal horn, with numerous Fos-like immunoreactive profiles in the ipsilateral dorsal horn and some contralateral immunoreactive profiles. In contrast, the level of Fos-like immunoreactivity in the transected group was significantly elevated and expanded in range compared to the sham group, with increases observed in the normal laminar distribution regions, as well as multisegmentally through sacral levels and increases in the contralateral dorsal horn segments. The data demonstrate that widespread activation of spinal, especially dorsal horn, neurons following peripheral insult can occur in the injured spinal cord, despite reduced pain responsiveness, and suggests that exaggerated pain may emerge as spinal recovery or repair progresses.

Executive Summary

In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions.

After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses.

The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html.

Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework

Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis

Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis

Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis

Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis

Long-term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis

Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis

Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis

Hospital-at-Home Programs for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis

Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis

Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model

Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature

For more information on the qualitative review, please contact Mita Giacomini at: http://fhs.mcmaster.ca/ceb/faculty_member_giacomini.htm.

For more information on the economic analysis, please visit the PATH website: http://www.path-hta.ca/About-Us/Contact-Us.aspx.

The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact.

Objective

The objective of this evidence-based analysis was to examine the effectiveness, safety, and cost-effectiveness of noninvasive positive pressure ventilation (NPPV) in the following patient populations: patients with acute respiratory failure (ARF) due to acute exacerbations of chronic obstructive pulmonary disease (COPD); weaning of COPD patients from invasive mechanical ventilation (IMV); and prevention of or treatment of recurrent respiratory failure in COPD patients after extubation from IMV.

Clinical Need and Target Population

Acute Hypercapnic Respiratory Failure

Respiratory failure occurs when the respiratory system cannot oxygenate the blood and/or remove carbon dioxide from the blood. It can be either acute or chronic and is classified as either hypoxemic (type I) or hypercapnic (type II) respiratory failure. Acute hypercapnic respiratory failure frequently occurs in COPD patients experiencing acute exacerbations of COPD, so this is the focus of this evidence-based analysis. Hypercapnic respiratory failure occurs due to a decrease in the drive to breathe, typically due to increased work to breathe in COPD patients.

Technology

There are several treatment options for ARF. Usual medical care (UMC) attempts to facilitate adequate oxygenation and treat the cause of the exacerbation, and typically consists of supplemental oxygen, and a variety of medications such as bronchodilators, corticosteroids, and antibiotics. The failure rate of UMC is high and has been estimated to occur in 10% to 50% of cases.

The alternative is mechanical ventilation, either invasive or noninvasive. Invasive mechanical ventilation involves sedating the patient, creating an artificial airway through endotracheal intubation, and attaching the patient to a ventilator. While this provides airway protection and direct access to drain sputum, it can lead to substantial morbidity, including tracheal injuries and ventilator-associated pneumonia (VAP).

While both positive and negative pressure noninvasive ventilation exists, noninvasive negative pressure ventilation such as the iron lung is no longer in use in Ontario. Noninvasive positive pressure ventilation provides ventilatory support through a facial or nasal mask and reduces inspiratory work. Noninvasive positive pressure ventilation can often be used intermittently for short periods of time to treat respiratory failure, which allows patients to continue to eat, drink, talk, and participate in their own treatment decisions. In addition, patients do not require sedation, airway defence mechanisms and swallowing functions are maintained, trauma to the trachea and larynx are avoided, and the risk for VAP is reduced. Common complications are damage to facial and nasal skin, higher incidence of gastric distension with aspiration risk, sleeping disorders, and conjunctivitis. In addition, NPPV does not allow direct access to the airway to drain secretions and requires patients to cooperate, and due to potential discomfort, compliance and tolerance may be low.

In addition to treating ARF, NPPV can be used to wean patients from IMV through the gradual removal of ventilation support until the patient can breathe spontaneously. Five to 30% of patients have difficultly weaning. Tapering levels of ventilatory support to wean patients from IMV can be achieved using IMV or NPPV. The use of NPPV helps to reduce the risk of VAP by shortening the time the patient is intubated.

Following extubation from IMV, ARF may recur, leading to extubation failure and the need for reintubation, which has been associated with increased risk of nosocomial pneumonia and mortality. To avoid these complications, NPPV has been proposed to help prevent ARF recurrence and/or to treat respiratory failure when it recurs, thereby preventing the need for reintubation.

Research Questions

What is the effectiveness, cost-effectiveness, and safety of NPPV for the treatment of acute hypercapnic respiratory failure due to acute exacerbations of COPD compared with

usual medical care, and

invasive mechanical ventilation?

What is the effectiveness, cost-effectiveness, and safety of NPPV compared with IMV in COPD patients after IMV for the following purposes:

weaning COPD patients from IMV,

preventing ARF in COPD patients after extubation from IMV, and

treating ARF in COPD patients after extubation from IMV?

Research Methods

Literature Search

A literature search was performed on December 3, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), Wiley Cochrane, and the Centre for Reviews and Dissemination/International Agency for Health Technology Assessment (INAHTA) for studies published from January 1, 2004 until December 3, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search.

Since there were numerous studies that examined the effectiveness of NPPV for the treatment of ARF due to exacerbations of COPD published before 2004, pre-2004 trials which met the inclusion/exclusion criteria for this evidence-based review were identified by hand-searching reference lists of included studies and systematic reviews.

Inclusion Criteria

English language full-reports;

health technology assessments, systematic reviews, meta-analyses, and randomized controlled trials (RCTs);

studies performed exclusively in patients with a diagnosis of COPD or studies performed with patients with a mix of conditions if results are reported for COPD patients separately;

patient population: (Question 1) patients with acute hypercapnic respiratory failure due to an exacerbation of COPD; (Question 2a) COPD patients being weaned from IMV; (Questions 2b and 2c) COPD patients who have been extubated from IMV.

Exclusion Criteria

< 18 years of age

animal studies

duplicate publications

grey literature

studies examining noninvasive negative pressure ventilation

studies comparing modes of ventilation

studies comparing patient-ventilation interfaces

studies examining outcomes not listed below, such as physiologic effects including heart rate, arterial blood gases, and blood pressure

Outcomes of Interest

mortality

intubation rates

length of stay (intensive care unit [ICU] and hospital)

health-related quality of life

breathlessness

duration of mechanical ventilation

weaning failure

complications

NPPV tolerance and compliance

Statistical Methods

When possible, results were pooled using Review Manager 5 Version 5.1, otherwise, the results were summarized descriptively. Dichotomous data were pooled into relative risks using random effects models and continuous data were pooled using weighted mean differences with a random effects model. Analyses using data from RCTs were done using intention-to-treat protocols; P values < 0.05 were considered significant. A priori subgroup analyses were planned for severity of respiratory failure, location of treatment (ICU or hospital ward), and mode of ventilation with additional subgroups as needed based on the literature. Post hoc sample size calculations were performed using STATA 10.1.

Quality of Evidence

The quality of each included study was assessed taking into consideration allocation concealment, randomization, blinding, power/sample size, withdrawals/dropouts, and intention-to-treat analyses.

The quality of the body of evidence was assessed as high, moderate, low, or very low according to the GRADE Working Group criteria. The following definitions of quality were used in grading the quality of the evidence:

Summary of Findings

NPPV for the Treatment of ARF due to Acute Exacerbations of COPD

NPPV Plus Usual Medical Care Versus Usual Medical Care Alone for First Line Treatment

A total of 1,000 participants were included in 11 RCTs1; the sample size ranged from 23 to 342. The mean age of the participants ranged from approximately 60 to 72 years of age. Based on either the Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD stage criteria or the mean percent predicted forced expiratory volume in 1 second (FEV1), 4 of the studies included people with severe COPD, and there was inadequate information to classify the remaining 7 studies by COPD severity. The severity of the respiratory failure was classified into 4 categories using the study population mean pH level as follows: mild (pH ≥ 7.35), moderate (7.30 ≤ pH < 7.35), severe (7.25 ≤ pH < 7.30), and very severe (pH < 7.25). Based on these categories, 3 studies included patients with a mild respiratory failure, 3 with moderate respiratory failure, 4 with severe respiratory failure, and 1 with very severe respiratory failure.

The studies were conducted either in the ICU (3 of 11 studies) or general or respiratory wards (8 of 11 studies) in hospitals, with patients in the NPPV group receiving bilevel positive airway pressure (BiPAP) ventilatory support, except in 2 studies, which used pressure support ventilation and volume cycled ventilation, respectively. Patients received ventilation through nasal, facial, or oronasal masks. All studies specified a protocol or schedule for NPPV delivery, but this varied substantially across the studies. For example, some studies restricted the amount of ventilation per day (e.g., 6 hours per day) and the number of days it was offered (e.g., maximum of 3 days); whereas, other studies provided patients with ventilation for as long as they could tolerate it and recommended it for much longer periods of time (e.g., 7 to 10 days). These differences are an important source of clinical heterogeneity between the studies. In addition to NPPV, all patients in the NPPV group also received UMC. Usual medical care varied between the studies, but common medications included supplemental oxygen, bronchodilators, corticosteroids, antibiotics, diuretics, and respiratory stimulators.

The individual quality of the studies ranged. Common methodological issues included lack of blinding and allocation concealment, and small sample sizes.

Need for Endotracheal Intubation

Eleven studies reported the need for endotracheal intubation as an outcome. The pooled results showed a significant reduction in the need for endotracheal intubation in the NPPV plus UMC group compared with the UMC alone group (relative risk [RR], 0.38; 95% confidence interval [CI], 0.28−0.50). When subgrouped by severity of respiratory failure, the results remained significant for the mild, severe, and very severe respiratory failure groups.

GRADE: moderate

Inhospital Mortality

Nine studies reported inhospital mortality as an outcome. The pooled results showed a significant reduction in inhospital mortality in the NPPV plus UMC group compared with the UMC group (RR, 0.53; 95% CI, 0.35−0.81). When subgrouped by severity of respiratory failure, the results remained significant for the moderate and severe respiratory failure groups.

GRADE: moderate

Hospital Length of Stay

Eleven studies reported hospital length of stay (LOS) as an outcome. The pooled results showed a significant decrease in the mean length of stay for the NPPV plus UMC group compared with the UMC alone group (weighted mean difference [WMD], −2.68 days; 95% CI, −4.41 to −0.94 days). When subgrouped by severity of respiratory failure, the results remained significant for the mild, severe, and very severe respiratory failure groups.

GRADE: moderate

Complications

Five studies reported complications. Common complications in the NPPV plus UMC group included pneumonia, gastrointestinal disorders or bleeds, skin abrasions, eye irritation, gastric insufflation, and sepsis. Similar complications were observed in the UMC group including pneumonia, sepsis, gastrointestinal disorders or bleeds, pneumothorax, and complicated endotracheal intubations. Many of the more serious complications in both groups occurred in those patients who required endotracheal intubation. Three of the studies compared complications in the NPPV plus UMC and UMC groups. While the data could not be pooled, overall, the NPPV plus UMC group experienced fewer complications than the UMC group.

GRADE: low

Tolerance/Compliance

Eight studies reported patient tolerance or compliance with NPPV as an outcome. NPPV intolerance ranged from 5% to 29%. NPPV tolerance was generally higher for patients with more severe respiratory failure. Compliance with the NPPV protocol was reported by 2 studies, which showed compliance decreases over time, even over short periods such as 3 days.

NPPV Versus IMV for the Treatment of Patients Who Failed Usual Medical Care

A total of 205 participants were included in 2 studies; the sample sizes of these studies were 49 and 156. The mean age of the patients was 71 to 73 years of age in 1 study, and the median age was 54 to 58 years of age in the second study. Based on either the GOLD COPD stage criteria or the mean percent predicted FEV1, patients in 1 study had very severe COPD. The COPD severity could not be classified in the second study. Both studies had study populations with a mean pH less than 7.23, which was classified as very severe respiratory failure in this analysis. One study enrolled patients with ARF due to acute exacerbations of COPD who had failed medical therapy. The patient population was not clearly defined in the second study, and it was not clear whether they had to have failed medical therapy before entry into the study.

Both studies were conducted in the ICU. Patients in the NPPV group received BiPAP ventilatory support through nasal or full facial masks. Patients in the IMV group received pressure support ventilation.

Common methodological issues included small sample size, lack of blinding, and unclear methods of randomization and allocation concealment. Due to the uncertainty about whether both studies included the same patient population and substantial differences in the direction and significance of the results, the results of the studies were not pooled.

Mortality

Both studies reported ICU mortality. Neither study showed a significant difference in ICU mortality between the NPPV and IMV groups, but 1 study showed a higher mortality rate in the NPPV group (21.7% vs. 11.5%) while the other study showed a lower mortality rate in the NPPV group (5.1% vs. 6.4%). One study reported 1-year mortality and showed a nonsignificant reduction in mortality in the NPPV group compared with the IMV group (26.1% vs. 46.1%).

GRADE: low to very low

Intensive Care Unit Length of Stay

Both studies reported LOS in the ICU. The results were inconsistent. One study showed a statistically significant shorter LOS in the NPPV group compared with the IMV group (5 ± 1.35 days vs. 9.29 ± 3 days; P < 0.001); whereas, the other study showed a nonsignificantly longer LOS in the NPPV group compared with the IMV group (22 ± 19 days vs. 21 ± 20 days; P = 0.86).

GRADE: very low

Duration of Mechanical Ventilation

Both studies reported the duration of mechanical ventilation (including both invasive and noninvasive ventilation). The results were inconsistent. One study showed a statistically significant shorter duration of mechanical ventilation in the NPPV group compared with the IMV group (3.92 ± 1.08 days vs. 7.17 ± 2.22 days; P < 0.001); whereas, the other study showed a nonsignificantly longer duration of mechanical ventilation in the NPPV group compared with the IMV group (16 ± 19 days vs. 15 ± 21 days; P = 0.86). GRADE: very low

Complications

Both studies reported ventilator-associated pneumonia and tracheotomies. Both showed a reduction in ventilator-associated pneumonia in the NPPV group compared with the IMV group, but the results were only significant in 1 study (13% vs. 34.6%, P = 0.07; and 6.4% vs. 37.2%, P < 0.001, respectively). Similarly, both studies showed a reduction in tracheotomies in the NPPV group compared with the IMV group, but the results were only significant in 1 study (13% vs. 23.1%, P = 0.29; and 6.4% vs. 34.6%; P < 0.001).

GRADE: very low

Other Outcomes

One of the studies followed patients for 12 months. At the end of follow-up, patients in the NPPV group had a significantly lower rate of needing de novo oxygen supplementation at home. In addition, the IMV group experienced significant increases in functional limitations due to COPD, while no increase was seen in the NPPV group. Finally, no significant differences were observed for hospital readmissions, ICU readmissions, and patients with an open tracheotomy, between the NPPV and IMV groups.

NPPV for Weaning COPD Patients From IMV

A total of 80 participants were included in the 2 RCTs; the sample sizes of the studies were 30 and 50 patients. The mean age of the participants ranged from 58 to 69 years of age. Based on either the GOLD COPD stage criteria or the mean percent predicted FEV1, both studies included patients with very severe COPD. Both studies also included patients with very severe respiratory failure (mean pH of the study populations was less than 7.23). Chronic obstructive pulmonary disease patients receiving IMV were enrolled in the study if they failed a T-piece weaning trial (spontaneous breathing test), so they could not be directly extubated from IMV.

Both studies were conducted in the ICU. Patients in the NPPV group received weaning using either BiPAP or pressure support ventilation NPPV through a face mask, and patients in the IMV weaning group received pressure support ventilation. In both cases, weaning was achieved by tapering the ventilation level.

The individual quality of the studies ranged. Common methodological problems included unclear randomization methods and allocation concealment, lack of blinding, and small sample size.

Mortality

Both studies reported mortality as an outcome. The pooled results showed a significant reduction in ICU mortality in the NPPV group compared with the IMV group (RR, 0.47; 95% CI, 0.23−0.97; P = 0.04).

GRADE: moderate

Intensive Care Unit Length of Stay

Both studies reported ICU LOS as an outcome. The pooled results showed a nonsignificant reduction in ICU LOS in the NPPV group compared with the IMV group (WMD, −5.21 days; 95% CI, −11.60 to 1.18 days).

GRADE: low

Duration of Mechanical Ventilation

Both studies reported duration of mechanical ventilation (including both invasive and noninvasive ventilation) as an outcome. The pooled results showed a nonsignificant reduction in duration of mechanical ventilation (WMD, −3.55 days; 95% CI, −8.55 to 1.44 days).

GRADE: low

Nosocomial Pneumonia

Both studies reported nosocominal pneumonia as an outcome. The pooled results showed a significant reduction in nosocomial pneumonia in the NPPV group compared with the IMV group (RR, 0.14; 95% CI, 0.03−0.71; P = 0.02).

GRADE: moderate

Weaning Failure

One study reported a significant reduction in weaning failure in the NPPV group compared with the IMV group, but the results were not reported in the publication. In this study, 1 of 25 patients in the NPPV group and 2 of 25 patients in the IMV group could not be weaned after 60 days in the ICU.

NPPV After Extubation of COPD Patients From IMV

The literature was reviewed to identify studies examining the effectiveness of NPPV compared with UMC in preventing recurrence of ARF after extubation from IMV or treating acute ARF which has recurred after extubation from IMV. No studies that included only COPD patients or reported results for COPD patients separately were identified for the prevention of ARF postextubation.

One study was identified for the treatment of ARF in COPD patients that recurred within 48 hours of extubation from IMV. This study included 221 patients, of whom 23 had COPD. A post hoc subgroup analysis was conducted examining the rate of reintubation in the COPD patients only. A nonsignificant reduction in the rate of reintubation was observed in the NPPV group compared with the UMC group (7 of 14 patients vs. 6 of 9 patients, P = 0.67). GRADE: low

Conclusions

NPPV Plus UMC Versus UMC Alone for First Line Treatment of ARF due to Acute Exacerbations of COPD

Moderate quality of evidence showed that compared with UMC, NPPV plus UMC significantly reduced the need for endotracheal intubation, inhospital mortality, and the mean length of hospital stay.

Low quality of evidence showed a lower rate of complications in the NPPV plus UMC group compared with the UMC group.

NPPV Versus IMV for the Treatment of ARF in Patients Who Have Failed UMC

Due to inconsistent and low to very low quality of evidence, there was insufficient evidence to draw conclusions on the comparison of NPPV versus IMV for patients who failed UMC.

NPPV for Weaning COPD Patients From IMV

Moderate quality of evidence showed that weaning COPD patients from IMV using NPPV results in significant reductions in mortality, nosocomial pneumonia, and weaning failure compared with weaning with IMV.

Low quality of evidence showed a nonsignificant reduction in the mean LOS and mean duration of mechanical ventilation in the NPPV group compared with the IMV group.

NPPV for the Treatment of ARF in COPD Patients After Extubation From IMV

Low quality of evidence showed a nonsignificant reduction in the rate of reintubation in the NPPV group compared with the UMC group; however, there was inadequate evidence to draw conclusions on the effectiveness of NPPV for the treatment of ARF in COPD patients after extubation from IMV

Psychotherapy conducted over the telephone has received increasing amounts of empirical attention given practical advantages that side-step treatment barriers encountered in traditional office-based care. The utility and efficacy of telephone therapy appears generalizable across diverse clinical populations seeking care in community-based hospital settings. Treatment barriers common to older adults suggest that telephone therapy may be an efficient and effective mental health resource for this population. This paper describes empirical studies of telehealth interventions and case examples with psychotherapy conducted via telephone on the Spinal Cord Injury Unit of the Palo Alto Veterans’ Administration. Telephone therapy as appears to be a viable intervention with the aging population.

Background

Natural disasters result in significant numbers of disabling impairments. Paradoxically, however, the traditional health system response to natural disasters largely neglects health-related rehabilitation as a strategic intervention.

Objectives

To examine the role of health-related rehabilitation in natural disaster relief along three lines of inquiry: (1) epidemiology of injury and disability, (2) impact on health and rehabilitation systems, and (3) the assessment and measurement of disability.

Design

Qualitative literature review and secondary data analysis.

Results

Absolute numbers of injuries as well as injury to death ratios in natural disasters have increased significantly over the last 40 years. Major impairments requiring health-related rehabilitation include amputations, traumatic brain injuries, spinal cord injuries (SCI), and long bone fractures. Studies show that persons with pre-existing disabilities are more likely to die in a natural disaster. Lack of health-related rehabilitation in natural disaster relief may result in additional burdening of the health system capacity, exacerbating baseline weak rehabilitation and health system infrastructure. Little scientific evidence on the effectiveness of health-related rehabilitation interventions following natural disaster exists, however. Although systematic assessment and measurement of disability after a natural disaster is currently lacking, new approaches have been suggested.

Conclusion

Health-related rehabilitation potentially results in decreased morbidity due to disabling injuries sustained during a natural disaster and is, therefore, an essential component of the medical response by the host and international communities. Significant systematic challenges to effective delivery of rehabilitation interventions during disaster include a lack of trained responders as well as a lack of medical recordkeeping, data collection, and established outcome measures. Additional development of health-related rehabilitation following natural disaster is urgently required.

Objective:

To identify the coping strategies used by adults with pediatric-onset spinal cord injuries (SCI) and to determine how these coping strategies were related to demographics, injury-related factors, and adult outcomes.

Methods:

Study Participants were adults who sustained SCI at age 18 years or younger and were interviewed at age 24 years or older. This is part of a large longitudinal study for which there were 864 eligible participants. There were 353 (41%) interviewed, 259 of which were assessed for coping skills. The telephone interview included a questionnaire and several standardized measures (Functional Independence Measure, Craig Handicap Assessment and Reporting Technique, Short-Form 12 measure of health-related quality of life, Satisfaction With Life Scale, Patient Health Questionnaire-9, and the Brief COPE adapted).

Results:

Of 259 participants, 62% were male and 58% had tetraplegia. The average age at injury was 14 years (0–18 years) and average age at interview was 30 years (24–42 years). Of 8 coping strategies assessed, 99% of participants used acceptance, 94% used positive reframing, 93% used active coping, 89% used emotional support, 89% used humor, and 74% used religion. The negative coping skills of behavioral disengagement and substance use were used by 28% and 15%, respectively. A hierarchical regression analysis was used to predict higher adult life satisfaction by using the positive coping strategies of seeking emotional support, acceptance, and religion; it was negatively associated with substance use.

Conclusions:

Positive coping strategies tend to be used by a majority of adults with pediatric-onset SCI, and several coping styles are associated with greater life satisfaction.

Objective

To evaluate the association of health status, secondary health conditions, hospitalizations, and risk of mortality and life expectancy (LE) after spinal cord injury (SCI).

Design

Prospective cohort study.

Setting

Preliminary data were collected from a specialty hospital in the Southeastern United States, with mortality follow-up and data analysis conducted at a medical university.

Participants

A total of 1361 adults with traumatic SCI, all at least 1 year post-injury at the time of assessment, were enrolled in the study. There were 325 deaths. After elimination of those with missing data on key variables, there were 267 deaths and 12,032 person-years.

Interventions

None

Main Outcome Measures

Mortality status was determined by routine follow-up using the National Death Index through December 31, 2008. A logistic regression model was developed to estimate the probability of dying in any given year using person years.

Results

A history of chronic pressure ulcers, amputations, a depressive disorder, symptoms of infections, and being hospitalized within the past year were all predictive of mortality. LE estimates were generated using the example of a male with non-cervical, non-ambulatory SCI. Using 3 age examples (20, 40, 60), the greatest estimated lost LE was associated with chronic pressure ulcers (50.3%), followed by amputations (35.4%), 1 or more recent hospitalizations (18.5%), and the diagnosis of probable major depression (18%). Symptoms of infections was associated with a 6.7% reduction in LE for a 1 standard deviation increase in infectious symptoms.

Conclusion

Several secondary health conditions represent risk factors for mortality and diminish LE after SCI. The presence of 1 or more of these factors should be taken as an indicator of the need for intervention.

Executive Summary

In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions.

After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses.

The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html.

Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework

Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis

Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis

Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis

Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis

Long-term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis

Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis

Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis

Hospital-at-Home Programs for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis

Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis

Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model

Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature

For more information on the qualitative review, please contact Mita Giacomini at: http://fhs.mcmaster.ca/ceb/faculty member_giacomini.htm.

For more information on the economic analysis, please visit the PATH website: http://www.path-hta.ca/About-Us/Contact-Us.aspx.

The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact.

Objective

The objective of this evidence-based analysis was to determine the effectiveness and cost-effectiveness of smoking cessation interventions in the management of chronic obstructive pulmonary disease (COPD).

Clinical Need: Condition and Target Population

Tobacco smoking is the main risk factor for COPD. It is estimated that 50% of older smokers develop COPD and more than 80% of COPD-associated morbidity is attributed to tobacco smoking. According to the Canadian Community Health Survey, 38.5% of Ontarians who smoke have COPD. In patients with a significant history of smoking, COPD is usually present with symptoms of progressive dyspnea (shortness of breath), cough, and sputum production. Patients with COPD who smoke have a particularly high level of nicotine dependence, and about 30.4% to 43% of patients with moderate to severe COPD continue to smoke. Despite the severe symptoms that COPD patients suffer, the majority of patients with COPD are unable to quit smoking on their own; each year only about 1% of smokers succeed in quitting on their own initiative.

Technology

Smoking cessation is the process of discontinuing the practice of inhaling a smoked substance. Smoking cessation can help to slow or halt the progression of COPD. Smoking cessation programs mainly target tobacco smoking, but may also encompass other substances that can be difficult to stop smoking due to the development of strong physical addictions or psychological dependencies resulting from their habitual use.

Smoking cessation strategies include both pharmacological and nonpharmacological (behavioural or psychosocial) approaches. The basic components of smoking cessation interventions include simple advice, written self-help materials, individual and group behavioural support, telephone quit lines, nicotine replacement therapy (NRT), and antidepressants. As nicotine addiction is a chronic, relapsing condition that usually requires several attempts to overcome, cessation support is often tailored to individual needs, while recognizing that in general, the more intensive the support, the greater the chance of success. Success at quitting smoking decreases in relation to:

a lack of motivation to quit,

a history of smoking more than a pack of cigarettes a day for more than 10 years,

a lack of social support, such as from family and friends, and

the presence of mental health disorders (such as depression).

Research Question

What are the effectiveness and cost-effectiveness of smoking cessation interventions compared with usual care for patients with COPD?

Research Methods

Literature Search

Search Strategy

A literature search was performed on June 24, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations (1950 to June Week 3 2010), EMBASE (1980 to 2010 Week 24), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Cochrane Library, and the Centre for Reviews and Dissemination for studies published between 1950 and June 2010. A single reviewer reviewed the abstracts and obtained full-text articles for those studies meeting the eligibility criteria. Reference lists were also examined for any additional relevant studies not identified through the search. Data were extracted using a standardized data abstraction form.

Inclusion Criteria

English-language, full reports from 1950 to week 3 of June, 2010;

either randomized controlled trials (RCTs), systematic reviews and meta-analyses, or non-RCTs with controls;

a proven diagnosis of COPD;

adult patients (≥ 18 years);

a smoking cessation intervention that comprised at least one of the treatment arms;

≥ 6 months’ abstinence as an outcome; and

patients followed for ≥ 6 months.

Exclusion Criteria

case reports

case series

Outcomes of Interest

≥ 6 months’ abstinence

Quality of Evidence

The quality of each included study was assessed taking into consideration allocation concealment, randomization, blinding, power/sample size, withdrawals/dropouts, and intention-to-treat analyses.

The quality of the body of evidence was assessed as high, moderate, low, or very low according to the GRADE Working Group criteria. The following definitions of quality were used in grading the quality of the evidence:

Summary of Findings

Nine RCTs were identified from the literature search. The sample sizes ranged from 74 to 5,887 participants. A total of 8,291 participants were included in the nine studies. The mean age of the patients in the studies ranged from 54 to 64 years. The majority of studies used the Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD staging criteria to stage the disease in study subjects. Studies included patients with mild COPD (2 studies), mild-moderate COPD (3 studies), moderate–severe COPD (1 study) and severe–very severe COPD (1 study). One study included persons at risk of COPD in addition to those with mild, moderate, or severe COPD, and 1 study did not define the stages of COPD. The individual quality of the studies was high. Smoking cessation interventions varied across studies and included counselling or pharmacotherapy or a combination of both. Two studies were delivered in a hospital setting, whereas the remaining 7 studies were delivered in an outpatient setting. All studies reported a usual care group or a placebo-controlled group (for the drug-only trials). The follow-up periods ranged from 6 months to 5 years. Due to excessive clinical heterogeneity in the interventions, studies were first grouped into categories of similar interventions; statistical pooling was subsequently performed, where appropriate. When possible, pooled estimates using relative risks for abstinence rates with 95% confidence intervals were calculated. The remaining studies were reported separately.

Abstinence Rates

Table ES1 provides a summary of the pooled estimates for abstinence, at longest follow-up, from the trials included in this review. It also shows the respective GRADE qualities of evidence.

Summary of Results*

Abbreviations: CI, confidence interval; NRT, nicotine replacement therapy.

Statistically significant (P < 0.05).

One trial used in this comparison had 2 treatment arms each examining a different antidepressant.

Conclusions

Based on a moderate quality of evidence, compared with usual care, abstinence rates are significantly higher in COPD patients receiving intensive counselling or a combination of intensive counselling and NRT.

Based on limited and moderate quality of evidence, abstinence rates are significantly higher in COPD patients receiving NRT compared with placebo.

Based on a moderate quality of evidence, abstinence rates are significantly higher in COPD patients receiving the antidepressant bupropion compared to placebo.

This article describes the development of a General Health Policy Model that can be used for program evaluation, population monitoring, clinical research, and policy analysis. An important component of the model, the Quality of Well-being scale (QWB) combines preference-weighted measures of symptoms and functioning to provide a numerical point-in-time expression of well-being, ranging from 0 for death to 1.0 for asymptomatic optimum functioning. The level of wellness at particular points in time is governed by the prognosis (transition rates or probabilities) generated by the underlying disease or injury under different treatment (control) variables. Well-years result from integrating the level of wellness, or health-related quality of life, over the life expectancy. Several issues relevant to the application of the model are discussed. It is suggested that a quality of life measure need not have separate components for social and mental health. Social health has been difficult to define; social support may be a poor criterion for resource allocation; and some evidence suggests that aspects of mental health are captured by the general measure. Although it has been suggested that measures of child health should differ from those used for adults, we argue that a separate conceptualization of child health creates new problems for policy analysis. After offering several applications of the model for the evaluation of prevention programs, we conclude that many of the advantages of general measures have been overlooked and should be given serious consideration in future studies.

Objective

We evaluate the effects of mode and order of administration on health-related quality of life (HRQOL) scores.

Method

We analyzed HRQOL data from the Clinical Outcomes and Measurement of Health Study (COMHS). In COMHS, we enrolled patients with heart failure or cataracts at three sites (University of California, San Diego, UCLA, and University of Wisconsin). Patients completed self-administered HRQOL instruments at baseline and months 1 and 6 post-baseline, including the EQ-5D, Health Utilities Index (HUI), Quality of Well-Being Scale—self-administered (QWB-SA) and the SF-36v2™. At the 6 month follow-up, individuals were randomized to mail or telephone administration first, followed by the other mode of administration. We used repeated measures mixed effects models, adjusting for site, patient age, education, gender and race.

Results

Included were 121 individuals entering a heart failure program and 326 individuals scheduled for cataract surgery who completed the survey by mail or phone at the 6-month follow-up. The majority of the sample was female (53%) and white (86%). About a quarter of the sample had high school education or less (26%). The average age was 66 (36–91 range). HRQOL scores were higher (more positive) for phone administration following mail administration. The largest differences in scores between phone and mail responses occurred for comparisons of telephone responses for those who were randomized to a mail survey first compared to mail responses for those randomized to a telephone survey first (i.e., mode effects for responses that were given on the second administration of the HRQOL measures). The QWB-SA was the only measure that did not display the pattern of mode effects. The biggest differences between modes were 4 points on the SF-36v2™ Physical Health and Mental Health Component Summary Scores, 0.06 on the SF-6D, 0.03 on the QWB-SA, 0.08 on the EQ-5D, 0.04 on the HUI2 and 0.10 on the HUI3.

Conclusions

Telephone administration yields significantly more positive HRQOL scores for all of the generic HRQOL measures except for the QWB-SA. The magnitude of effects was clearly important, with some differences as large as a half-standard deviation. These findings confirm the importance of considering mode of administration when interpreting HRQOL scores.

Background

Spinal cord-injured (SCI) patients experience poor health-related quality of life (HRQOL) and they usually report lower HRQOL than the general population or population subgroups in Iran and elsewhere. The aim of this study was to compare HRQOL between veterans and non-veterans with SCI in Iran.

Methods

This was a cross-sectional study. HRQOL was measured using the 36-item Short Form Health Survey (SF-36). Thirty-nine male veterans and 63 non-veteran males with SCI were included in the study. Regression analyses were applied to determine the variables affecting physical and mental health-related quality of life among the patients.

Results

The male veterans had a lower HRQOL than the non-veterans with SCI. The differences were significant for all measures except for physical and social functioning. The greatest difference was observed for bodily pain (P = 0.001). The regression analysis results indicated that a longer time since injury was associated (P = 0.01) with better physical health-related quality of life (PCS), while being a veteran (P < 0.001) and having a spinal lesion in the cervical region (P = 0.001) were associated with poorer PCS. Older age (P < 0.001) and higher education (P = 0.01) were associated with better mental health-related quality of life (MCS), while being a veteran and having a spinal lesion in the cervical region (P = 0.02) were associated with poorer MCS.

Conclusion

The study findings showed that veterans with SCI experienced lower HRQOL than their non-veteran counterparts. A qualitative study is recommended to evaluate why HRQOL was lower in veterans than in non-veterans with SCI although veterans had higher incomes as a result of their pensions and increased access to equipment, and medications. To improve quality of life in both veterans and non-veterans with spinal cord injuries, policy changes or implementation of new interventions may be essential so that veterans could receive additional support (e.g. counseling, recreation therapy, vocational therapy, etc.) and non-veterans could meet their basic needs.

Context:

Social work and case management (SW/CM) are integral components of acute inpatient spinal cord injury (SCI) rehabilitation. However, evidence is sparse regarding the impact of SW/CM interventions on outcomes. To advance research on SW/CM clinical practice in SCI rehabilitation, SW/CM providers and researchers first must have standard classifications for SW/CM interventions.

Background/Objective:

To develop a taxonomy (classification) of the various interventions and services that comprise SW/CM.

Methods:

A group of SW/CM clinicians compiled a list of activities performed as routine practice at the participating rehabilitation facilities. These activities were grouped and defined systematically.

Results:

The resulting taxonomy includes 8 major activity topics (financial planning, discharge planning, discharge services, supportive counseling, information about and referral to peer/advocacy groups, education about SCI and other relevant topics, information about and referral to community/in-house services, and team conferences), which were further stratified into specific content areas. Interactions with the patient, family, or other team members and resources, along with descriptions of the interactions that are applicable to each of the 8 activity topics, were included as well.

Conclusion:

An intervention taxonomy is required to study the SW/CM interventions and the potential association with positive rehabilitation outcomes for patients with SCI. The SW/CM taxonomy developed for the SCIRehab project, which will be used with 1,500 patients admitted to 6 SCIRehab centers over 2.5 years, will provide an infrastructure for such research.

Aim

Examine the construct validity of generic preference-weighted health-related quality of life measures in a sample of patients with a substance use disorder (SUD).

Design

Longitudinal (baseline and six-month follow-up) data from a research study that evaluated interventions to improve linkage and engagement with SUD treatment.

Setting

A central intake unit that referred patients to seven SUD treatment centers in a Midwestern US metropolitan area.

Participants

495 persons with a SUD.

Measurements

Participants completed two preference-weighted measures: self-administered Quality of Well-Being scale (QWB-SA) and standard gamble weighted Medical Outcomes Study SF-12 (SF-6D). They were also administered two clinical assessments: all seven domains of the Addiction Severity Index (ASI) and a symptom checklist based on the DSM-IV. Construct validity was determined via the relationships between disease-specific SUD and generic measures.

Findings

In unadjusted analyses, the QWB-SA and SF-6D change scores were significantly correlated with six ASI subscale change scores, but not with employment status. In adjusted repeated measures analyses, 3/7 ASI subscale scores were significant predictors of QWB-SA and 5/7 ASI subscale scores were significant predictors of SF-6D. Abstinence and problematic use at follow-up were significant predictors of QWB-SA and SF-6D. Effect sizes ranged from 0.352 to 0.400 for abstinence and −0.484 to −0.585 for problematic use.

Conclusions

Generic preference-weighted health-related quality of life measures show moderate to good associations with substance-use specific measures and in certain circumstances can be used in their stead. This study provides further support for the use of the QWB-SA and SF-6D in clinical and economic evaluations of SUD interventions.

Background

Quantification of body composition variables is important for planning of better activities in relation to individuals with spinal cord injury (SCI).

Objectives

(1) To evaluate changes in body composition in patients with SCI after a supervised physical activity process; (2) To correlate total body fat with time since injury.

Design

Pre-post intervention.

Setting

Sarah Rehabilitation Hospital Network, Brazil.

Participants

Fifty-three men with SCI aged 18–52 years with duration of injury >3 years.

Interventions

The subjects were divided into three groups: tetraplegia (TT) (C5–C8), high paraplegia (HP) (T1–T6), and low paraplegia (LP) (T7–L2). Body composition was estimated in the first and last weeks of hospitalization.

Outcome measures

Body weight (kg), skinfolds sum (mm), absolute (kg), and relative (%) fat and lean body mass.

Results

Body weight increased in TT and decreased in HP (0.8 kg, 95%CI 0.1–1.5; and −1.0 kg, 95%CI −2.0 to 0.0, respectively; P < 0.05). Skinfolds sum decreased only in HP (−13.1 mm, 95%CI −20.7 to −5.5; P < 0.05). Absolute and relative body fat decreased significantly in the paraplegia groups. Lean body mass (LBM) percentage increased significantly in the paraplegia groups. Absolute LBM increased in TT and LP (0.8 kg, 95%CI 0.3–1.3; and 1.3 kg, 95%CI 0.8 to 1.8, respectively; P < 0.05). There was no correlation between time since injury and skinfolds sum for the three groups (P < 0.05).

Conclusion

TT, HP, and LP demonstrated favorable changes in body composition after 29 days of supervised physical activity. However, these changes were different in direction and magnitude.