A catalyst for transforming health systems and person-centred care: Canadian national position statement on patient-reported outcomes.

Background: Patient-reported outcomes (pros) are essential to capture the patient's perspective and to influence care. Although pros and pro measures are known to have many important benefits, they are not consistently being used and there is there no Canadian pros oversight. The Position Statement presented here is the first step toward supporting the implementation of pros in the Canadian health care setting. Methods: The Canadian pros National Steering Committee drafted position statements, which were submitted for stakeholder feedback before, during, and after the first National Canadian Patient Reported Outcomes (canpros) scientific conference, 14-15 November 2019 in Calgary, Alberta. In addition to the stakeholder feedback cycle, a patient advocate group submitted a section to capture the patient voice. Results: The canpros Position Statement is an outcome of the 2019 canpros scientific conference, with an oncology focus. The Position Statement is categorized into 6 sections covering 4 theme areas: Patient and Families, Health Policy, Clinical Implementation, and Research. The patient voice perfectly mirrors the recommendations that the experts reached by consensus and provides an overriding impetus for the use of pros in health care. Conclusions: Although our vision of pros transforming the health care system to be more patient-centred is still aspirational, the Position Statement presented here takes a first step toward providing recommendations in key areas to align Canadian efforts. The Position Statement is directed toward a health policy audience; future iterations will target other audiences, including researchers, clinicians, and patients. Our intent is that future versions will broaden the focus to include chronic diseases beyond cancer.

Current level of technology use, health and eHealth literacy in older Canadians with a recent fracture-a survey in orthopedic clinics.

Among older adults who have recently sustained a fracture, there is substantial adoption of mobile technology. Furthermore, health and eHealth literacy level reported by participants supports the development of interactive eHealth interventions toward fostering better patient engagement in skeletal health management. INTRODUCTION: Electronic health resources are increasingly used in the self-management of medical conditions. We aimed to identify the current level of technology adoption, health, and eHealth literacy among older adults with a recent fracture, to determine if the use of electronic interventions would be feasible and acceptable in this population. METHODS: Adults ≥ 50 years with recent fractures were invited to complete a self-administered survey composed of 21 questions, including an 8-item perceived eHealth literacy scale. RESULTS: A total of 401 participants completed the survey (women, 64%; ≥ 65 years, 59%; university education, 32%). Most participants reported no difficulty in reading printed health material (67%) and felt confident in filling out medical forms (65%). Younger age and higher levels of education were associated with higher health literacy. Most respondents (81%) owned at least one mobile device (smartphone, 49%; tablet, 45%). eHEALS scores were similar among men (29, IQR 24-32) and women (29, IQR 25-33), and between younger age group categories (50-64 years, 30; IQR 26-33; and 65-74 years, 29; IQR 25-32), but lower in the oldest age group (≥ 75 years, 24; IQR 21-29; p < 0.05). Compared with the youngest group, those ≥ 75 years had higher odds of an eHEALS < 26 (odds ratio, 4.2; 95% confidence interval 2.0-8.9) after adjusting for sex and education level. CONCLUSION: There is significant adoption of mobile technology among older adults. Health and eHealth literacy reported by this study population supports the development of interactive eHealth interventions toward fostering better patient engagement in skeletal health management.

Putting the best foot forward: Relationships between indicators of step quality and cadence in three gait vulnerable populations.

BACKGROUND: Aging and neurological conditions like Multiple Sclerosis (MS) and Parkinson's disease (PD) make people vulnerable for gait impairments, limit function, and restrict sustained walking needed for health promotion. Walking to meet physical activity guidelines requires adequate cadence which is difficult to achieve for gait vulnerable populations. OBJECTIVE: The objective of this study is to estimate, for seniors and people with MS or PD, the extent to which cadence is associated with heel-to-toe stepping pattern (good steps), angular velocity of ankle at heel-strike and its variability. METHODS: A cross-sectional regression analysis was performed on data collected during walking tests using the Heel2Toe sensor. RESULTS: Health condition (MS = 57, PD = 27, seniors = 56) had an association with cadence, independent of age and sex. Only angular velocity showed a significant relationship with cadence such that every - 50° difference in angular velocity (more negative is better) was associated with a difference of ≈3.5 steps per minute. CONCLUSION: Adequate angular velocity occurs with an optimal heel-to-toe movement. This heel-to-toe gait can easily be targeted during therapy but technology would be an asset to sustain the relearned movement during everyday activities, Technology that provides real-time feedback for steps with adequate angular velocity at heel strike could be a valuable therapeutic adjunct.

Outcomes reported in high-impact surgical journals.

BACKGROUND: With advances in operative technique and perioperative care, traditional endpoints such as morbidity and mortality provide an incomplete description of surgical outcomes. There is increasing emphasis on the need for patient-reported outcomes (PROs) to evaluate fully the effectiveness and quality of surgical interventions. The objective of this study was to identify the outcomes reported in clinical studies published in high-impact surgical journals and the frequency with which PROs are used. METHODS: Electronic versions of material published between 2008 and 2012 in the four highest-impact non-subspecialty surgical journals (Annals of Surgery, British Journal of Surgery (BJS), Journal of the American College of Surgeons (JACS), Journal of the American Medical Association (JAMA) Surgery) were hand-searched. Clinical studies of adult patients undergoing planned abdominal, thoracic or vascular surgery were included. Reported outcomes were classified into five categories using Wilson and Cleary's conceptual model. RESULTS: A total of 893 articles were assessed, of which 770 were included in the analysis. Some 91·6 per cent of studies reported biological and physiological outcomes, 36·0 per cent symptoms, 13·4 per cent direct indicators of functional status, 10·6 per cent general health perception and 14·8 per cent overall quality of life (QoL). The proportion of studies with at least one PRO was 38·7 per cent overall and 73·4 per cent in BJS (P < 0·001). The proportion of studies using a formal measure of health-related QoL ranged from 8·9 per cent (JAMA Surgery) to 33·8 per cent (BJS). CONCLUSION: The predominant reporting of clinical endpoints and the inconsistent use of PROs underscore the need for further research and education to enhance the applicability of these measures in specific surgical settings.

Systematic review of outcomes used to evaluate enhanced recovery after surgery.

BACKGROUND: Enhanced recovery pathways (ERPs) aim to improve patient recovery. However, validated outcome measures to evaluate this complex process are lacking. The objective of this review was to identify how recovery is measured in ERP studies and to provide recommendations for the design of future studies. METHODS: A systematic search of MEDLINE, Embase and Cochrane databases was conducted. Prospective studies evaluating ERPs compared with traditional care in abdominal surgery published between 2000 and 2013 were included. All reported outcomes were classified into categories: biological and physiological variables, symptom status, functional status, general health perceptions and quality of life (QoL). The phase of recovery measured was defined as baseline, intermediate (in hospital) and late (following discharge). RESULTS: A total of 38 studies were included based on the systematic review criteria. Biological or physiological variables other than postoperative complications were reported in 30 studies, and included return of gastrointestinal function (25 studies), pulmonary function (5) and physical strength (3). Patient-reported symptoms, including pain (16 studies) and fatigue (9), were reported less commonly. Reporting of functional status outcomes, including mobilization (16 studies) and ability to perform activities of daily living (4), was similarly uncommon. Health aspects of QoL were reported in only seven studies. Length of follow-up was generally short, with 24 studies reporting outcomes within 30 days or less. All studies documented in-hospital outcomes (intermediate phase), but only 17 reported postdischarge outcomes (late phase) other than complications or readmission. CONCLUSION: Patient-reported outcomes, particularly postdischarge functional status, were not commonly reported. Future studies of the effectiveness of ERPs should include validated, patient-reported outcomes to estimate better their impact on recovery, particularly after discharge from hospital.

Independent contributors to overall quality of life in people with advanced cancer.

BACKGROUND: The definition of health for people with cancer is not focused solely on the physiology of illness and the length of life remaining, but is also concerned with improving the well-being and the quality of the life (QOL) remaining to be lived. This study aimed to identify the constructs most associated with QOL in people with advanced cancer. METHODS: Two hundred three persons with recent diagnoses of different advanced cancers were evaluated with 65 variables representing individual and environmental factors, biological factors, symptoms, function, general health perceptions and overall QOL at diagnosis. Three independent stepwise multiple linear regressions identified the most important contributors to overall QOL. R(2) ranking and effect sizes were estimated and averaged by construct. RESULTS: The most important contributor of overall QOL for people recently diagnosed with advanced cancer was social support. It was followed by general health perceptions, energy, social function, psychological function and physical function. CONCLUSIONS: We used effect sizes to summarise multiple multivariate linear regressions for a more manageable and clinically interpretable picture. The findings emphasise the importance of incorporating the assessment and treatment of relevant symptoms, functions and social support in people recently diagnosed with advanced cancer as part of their clinical care.

Trajectories of endurance activity following pulmonary rehabilitation in COPD patients.

Maintenance of physical activity following pulmonary rehabilitation remains a challenge for patients with chronic obstructive pulmonary disease (COPD). The objectives of this study were to identify patterns of endurance activity after completion of pulmonary rehabilitation and to characterise people who succeed and those who have difficulty maintaining endurance activity. In a longitudinal study embedded within a randomised clinical trial, 206 individuals with COPD underwent a 3-month pulmonary rehabilitation programme. Weekly duration of endurance activity was assessed at 4, 6, 8 and 12 months after the start of rehabilitation. Trajectory modelling was used to determine the most common patterns of activity during the post-rehabilitation phase from 4-12 months. Three distinct patterns were identified, two of which indicated difficulty in maintaining endurance activity: 61 individuals reported a high activity level at 4 months (2.7 h·week(-1)) and stayed high; 114 individuals started at a low activity level (mean 1.0 h·week(-1)) and stayed low; and 31 individuals started high (3.0 h·week(-1)) and declined. The low activity group was characterised by more severe disease and greater respiratory impairment. The high and declined group had less severe disease and respiratory impairment, but reported greater barriers to exercise. Pulmonary rehabilitation should include interventions aimed at minimising barriers, in order to induce long-term behaviour change.

Randomized clinical trial of prehabilitation in colorectal surgery.

BACKGROUND: 'Prehabilitation' is an intervention to enhance functional capacity in anticipation of a forthcoming physiological stressor. In patients scheduled for colorectal surgery, the extent to which a structured prehabilitation regimen of stationary cycling and strengthening optimized recovery of functional walking capacity after surgery was compared with a simpler regimen of walking and breathing exercises. METHODS: Some 112 patients (mean(s.d.) age 60(16) years) were randomized to either the structured bike and strengthening regimen (bike/strengthening group, 58 patients) or the simpler walking and breathing regimen (walk/breathing group, 54 patients). Randomization was done at the surgical planning visit; the mean time to surgery available for prehabilitation was 52 days; follow-up was for approximately 10 weeks after surgery. RESULTS: There were no differences between the groups in mean functional walking capacity over the prehabilitation period or at postoperative follow-up. The proportion showing an improvement in walking capacity was greater in the walk/breathing group than in the bike/strengthening group at the end of the prehabilitation period (47 versus 22 per cent respectively; P = 0.051) and after surgery (41 versus 11 per cent; P = 0.019). CONCLUSION: There was an unexpected benefit from the recommendation to increase walking and breathing, as designed for the control group. Adherence to recommendations was low. An examination of prehabilitation 'responders' would add valuable information.

Pulmonary diffusion and aerobic capacity: is there a relation? Does obesity matter?

AIM: We sought to determine whether pulmonary diffusing capacity for nitric oxide (DLNO), carbon monoxide (DLCO) and pulmonary capillary blood volume (Vc) at rest predict peak aerobic capacity (VO2peak), and if so, to discern which measure predicts better. METHODS: Thirty-five individuals with extreme obesity (body mass index or BMI = 50 +/- 8 kg m((-2)) and 26 fit, non-obese subjects (BMI = 23 +/- 2 kg m((-2)) participated. DLNO and DLCO at rest were first measured. Then, subjects performed a graded exercise test on a cycle ergometer to determine (VO2peak). Multivariate regression was used to assess relations in the data. RESULTS: Findings indicate that (i) pulmonary diffusion at rest predicts (VO2peak) in the fit and obese when measured with DLNO, but only in the fit when measured with DLCO; (ii) the observed relation between pulmonary diffusion at rest and (VO2peak) is different in the fit and obese; (iii) DLNO explains (VO2peak) better than DLCO or Vc. The findings imply the following reference equations for DLNO: (VO2peak) (mL kg(-1) min(-1)) = 6.81 + 0.27 x DLNO for fit individuals; (VO2peak) (mL kg(-1) min(-1)) = 6.81 + 0.06 x DLNO, for obese individuals (in both groups, adjusted R(2 )=( )0.92; RMSE = 5.58). CONCLUSION: Pulmonary diffusion at rest predicts (VO2peak), although a relation exists for obese subjects only when DLNO is used, and the magnitude of the relation depends on gender when either DLCO or Vc is used. We recommend DLNO as a measure of pulmonary diffusion, both for its ease of collection as well as its tighter relation with (VO2peak).

What does a structured review of the effectiveness of exercise interventions for persons with multiple sclerosis tell us about the challenges of designing trials?

OBJECTIVE: The goal of this review is to ascertain the extent to which the current body of research on the role of exercise in multiple sclerosis (MS) provides sufficiently strong evidence to guide regular exercise prescription. METHODS: We searched CINAHL, COCHRANE, EMBASE, and MEDLINE between 1950 and December 2007 with combinations of MeSH terms and keywords. We assessed the methodological quality of selected randomized controlled trials (RCTs) of exercise interventions using the Physiotherapy Evidence Database scale and evaluated the effects of the exercise interventions by calculating effect sizes (ES) for the target outcomes. RESULTS: Eleven RCTs met the criteria, all with acceptable methodological quality. The ES ranged from -0.36 to 3.50 on the target outcomes. Only one study had 95% confidence intervals clearly excluding a value of 0. Measures of body functions and structures and activities were the most common target outcomes of interventions. CONCLUSION: Although there was some evidence to support positive effects of exercise on physical and psychosocial functioning and on quality of life, our review revealed insufficient research in this area, making it difficult to guide regular exercise prescription. Furthermore, it also emphasizes the methodological challenges in these RCTs leading us to believe that there is a great need for high quality RCTs in this area, contributing evidence for regular exercise and physical activity prescription for persons with MS.

A panel study in congestive heart failure to estimate the short-term effects from personal factors and environmental conditions on oxygen saturation and pulse rate.

OBJECTIVES: Recent studies suggest that persons with congestive heart failure (CHF) may be at higher risk for short-term effects of air pollution. This daily diary panel study in Montreal, Quebec, was carried out to determine whether oxygen saturation and pulse rate were associated with selected personal factors, weather conditions and air pollution. METHODS: Thirty-one subjects with CHF participated in this study in 2002 and 2003. Over a 2-month period, the investigators measured their oxygen saturation, pulse rate, weight and temperature each morning and recorded these and other data in a daily diary. Air pollution and weather conditions were obtained from fixed-site monitoring stations. The study made use of mixed regression models, adjusting for within-subject serial correlation and temporal trends, to determine the association between oxygen saturation and pulse rate and personal and environmental variables. Depending on the model, we accounted for the effects of a variety of personal variables (eg, body temperature, salt consumption) as well as nitrogen dioxide (NO2), ozone, maximum temperature and change in barometric pressure at 8:00 from the previous day. RESULTS: In multivariable analyses, the study found that oxygen saturation was reduced when subjects reported that they were ill, consumed salt, or drank liquids on the previous day and had higher body temperatures on the concurrent day (only the latter was statistically significant). Relative humidity and decreased atmospheric pressure from the previous day were associated with oxygen saturation. In univariate analyses, there was negative associations with concentrations of fine particulates, ozone, and sulphur dioxide (SO2), but only SO2 was significant after adjustment for the effects of weather. For pulse rate, no associations were found for the personal variables and in univariate analyses the study found positive associations with NO(2), fine particulates (aerodynamic diameter of 2.5 microm or under, PM(2.5)), SO2, and maximum temperature, although only the latter two were significant after adjustment for environmental effects. CONCLUSIONS: The findings from the present investigation suggest that personal and environmental conditions affect intermediate physiological parameters that may affect the health of CHF patients.

A task-orientated intervention enhances walking distance and speed in the first year post stroke: a randomized controlled trial.

OBJECTIVE: To evaluate the efficacy of a task-orientated intervention in enhancing competence in walking in people with stroke. DESIGN: Two-centre observer-blinded stratified block-randomized controlled trial. SETTING: General community. SUBJECTS: Between May 2000 and February 2003, 91 individuals with a residual walking deficit within one year of a first or recurrent stroke consented to participate. INTERVENTIONS: The experimental intervention comprised 10 functional tasks designed to strengthen the lower extremities and enhance walking balance, speed and distance. The control intervention involved the practice of upper extremity activities. Subjects in both groups attended sessions three times a week for six weeks. MAIN MEASURES: Six-minute walk test (SMWT), 5-m walk (comfortable and maximum pace), Berg Balance Scale, timed 'up and go'. RESULTS: At baseline, subjects in the experimental (n = 44) and control (n = 47) groups walked an average distance of 209 m (SD = 126) and 204 m (SD =131), respectively, on the SMWT. Mean improvements of 40 m (SD =72), and 5 m (SD =66) were observed following the experimental and control interventions, respectively. The between-group difference was 35 m (95% confidence interval (CI) 7, 64). Significant between-group effects of 0.21 m/s (95% CI 0.12, 0.30) and of 0.11 m/s (95% CI 0.03, 0.19) in maximum and comfortable walking speed, respectively, were observed. People with a mild, moderate or severe walking deficit at baseline improved an average of 36 (SD =96), 55 (SD = 56) and 18 m (SD = 23), respectively, in SMWT performance following the experimental intervention. CONCLUSIONS: Study findings support the efficacy of a task-orientated intervention in enhancing walking distance and speed in the first year post stroke, particularly in people with moderate walking deficits.

Responsiveness and predictability of gait speed and other disability measures in acute stroke.

OBJECTIVES: To identify the most responsive method of measuring gait speed, to estimate the responsiveness of other outcome measures, and to determine whether gait speed predicts discharge destination in acute stroke. DESIGN: A prospective cohort study. SETTING: Five acute-care hospitals. PATIENTS: Fifty subjects with residual gait deficits after a first-time stroke. INTERVENTIONS: Five- (5mWT) and 10-meter walk tests (10mWT) at comfortable and maximum speeds, with 2 evaluations conducted an average +/- standard deviation (SD) of 8 +/- 3 and 38 +/- 5 days poststroke. MAIN OUTCOME MEASURE: Standardized response mean (SRM = mean change/SD of change) was used to estimate responsiveness for each walk test, the Berg Balance Scale, the Barthel Index, the Stroke Rehabilitation Assessment of Movement (STREAM), and the Timed Up and Go (TUG). RESULTS: The SRMs were 1.22 and 1.00 for the 5mWT, and.92 and.83 for the 10mWT performed at a comfortable and maximum pace, respectively. The SRMs for the Berg Balance Scale, the Barthel Index, the STREAM, and the TUG were 1.04,.99,.89, and.73, respectively. The probability of discharge to a rehabilitation center for persons walking at < or = 0.3m/s or > 0.6m/s at the first evaluation was.95 and.22, respectively. CONCLUSIONS: The 5mWT at a comfortable pace is recommended as the measure of choice for clinicians and researchers who need to detect longitudinal change in walking disability in the first 5 weeks poststroke.

Waiting time for breast cancer surgery in Quebec.

BACKGROUND: Currently there is no agreement on the optimal time to treatment of breast cancer; however, given the considerable emphasis on early detection, one would expect a similar emphasis on early treatment. The purpose of our study was to assess the time interval to surgery from initiation of diagnosis among Quebec women with breast cancer and to examine the influence on waiting time of age, pattern of care and cancer stage. METHODS: Records of physician fee-for-service claims and of hospital admissions were obtained for all Quebec women who underwent an invasive procedure for the diagnosis or treatment of breast cancer between 1992 and 1998. Waiting time was calculated as the number of days between the first diagnostic procedure and surgical treatment. RESULTS: There were 29,606 episodes of breast cancer surgery among 28,100 women: 5922 mastectomies and 23,684 lumpectomies. The absolute number of episodes of breast cancer treated with surgery rose from 3626 in 1992 to 5162 in 1998. The overall median waiting time was 34 days (interquartile range [IQR] 19-62); 13.5% of the women waited longer than 90 days. The median waiting time rose from 29 days (IQR 15-54) in 1992 to 42 days (IQR 24-72) in 1998, representing a relative increase of 37% (95% confidence interval [CI] 32%-43%) after adjusting for age and cancer stage. The median waiting time increased with the number of diagnostic procedures, from 24 days (IQR 14-42) with 1 procedure to 48 days (IQR 27-84) with 3 procedures to 72 days (IQR 43-121) with 4 procedures, representing adjusted relative increases of 97% (95% CI 91%-103%) and 194% (95% CI 181%-208%), respectively. The proportion of women receiving 3 or more diagnostic procedures before surgery increased steadily over the study period, from 19.2% in 1992 to 33.0% in 1998. The median waiting time was shorter with more advanced stages of cancer: 53 days (IQR 30-86) for carcinoma in situ, 35 (IQR 20-62) for localized disease, 28 (IQR 16-49) for regional disease and 24 (IQR 11-52) for disseminated disease. INTERPRETATION: Waiting time between initial diagnosis and first surgery for breast cancer has increased substantially in Quebec between 1992 and 1998. Possible explanations include increased demand, decreased resources and changes in patterns of care.

The relationship between health related quality of life and disease activity and damage in systemic lupus erythematosus.

OBJECTIVE: To evaluate the relationship between self-reported quality of life and disease activity, damage, impairment, disability, and handicap in systemic lupus erythematosus (SLE). METHODS: In this cross sectional study disease activity was measured with the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and the Systemic Lupus Activity Measure (SLAM), and damage by the Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) damage index (SDI). Quality of life was assessed by the Medical Outcome Survey Short Form 36 (SF-36) and the EuroQol (EQ-5D). Multiple linear regression was used to identify significant associations of patients' health status, and logistic regression was used to evaluate the relationship of each of the 5 dimensions of the EQ-5D in terms of impairment, disability, and handicap. RESULTS: Damage was associated with the Physical Function (PF) and Social Function subscales of the SF-36. Disease activity was associated with the General Health (GH) subscale. Ability to carry out usual activities was strongly related to PF and GH as well as to global rating of the thermometer rating scale of the EQ-5D. Role Physical (RP) and Bodily Pain (BP) of the SF-36 were also associated with the EQ-5D rating scale. In addition, patients' ratings of anxiety and depression were strongly related to the Mental Health (MH) summary scale of the SF-36. CONCLUSION: Perceived health status of patients with lupus was associated with disease activity, damage, role physical, bodily pain, capacity for usual activity, and mobility. EQ-5D is a valid instrument for the measure of health related quality of life in SLE.

There's no place like home : an evaluation of early supported discharge for stroke.

BACKGROUND AND PURPOSE: Because stroke management is aimed at facilitating community reintegration, it would be logical that the sooner the patient can be discharged home, the sooner reintegration can commence. The purpose of this study was to determine the effectiveness of prompt discharge combined with home rehabilitation on function, community reintegration, and health-related quality of life during the first 3 months after stroke. METHODS: A randomized trial was carried out involving patients who required rehabilitation services and who had a caregiver at home. When medically ready for discharge, persons with stroke were randomized to either the home intervention group (n=58) or the usual care group (n=56). The home group received a 4-week, tailor-made home program of rehabilitation and nursing services; persons randomized to the usual care group received services provided through a variety of mechanisms, depending on institutional, care provider, and personal preference. The main outcome measure was the Physical Health component of the Measuring Outcomes Study Short-Form-36 (SF-36). Associated outcomes measures included the Timed Up & Go (TUG), Barthel Index (BI), the Older Americans Resource Scale for instrumental activities of daily living (OARS-IADL), Reintegration to Normal Living (RNL), and the SF-36 Mental Health component. RESULTS: The total length of stay for the home group was, on average, 10 days, 6 days shorter than that for the usual care group. There were no differences between the 2 groups on the BI or on the TUG at either 1 or 3 months after stroke; however, there was a significantly beneficial impact of the home intervention on IADL and reintegration (RNL). By 3 months after stroke, the home intervention group showed a significantly higher score on the SF-36 Physical Health component than the usual care group. The total number of services received by the home group was actually lower than that received by the usual care group. CONCLUSIONS: Prompt discharge combined with home rehabilitation appeared to translate motor and functional gains that occur through natural recovery and rehabilitation into a greater degree of higher-level function and satisfaction with community reintegration, and these in turn were translated into a better physical health.

A review of the association between cigarette smoking and the development of nonspecific back pain and related outcomes.

STUDY DESIGN: A structured review of the epidemiologic literature was performed. Thirty-eight studies published in peer-reviewed journals were reviewed. The methodologic strengths and weaknesses of the studies were described and assessed qualitatively. Four studies were excluded because of difficulties in design or interpretation. OBJECTIVES: To provide a systematic analysis of the literature to assess the evidence as to whether smoking is associated with the prevalence and incidence of nonspecific back pain and related outcomes. SUMMARY OF BACKGROUND DATA: Evidence has been gathering regarding the association of smoking with nonspecific back pain and other back disorders, but a comprehensive summary and evaluation of the data have not been published. RESULTS: Positive associations between current smoking and nonspecific back pain were found in 18 of 26 studies in men and 18 of 20 studies in women. For sciatica and herniated discs, there were four of eight and one of five positive studies in men and women, respectively. The majority of these studies were cross-sectional (18 in men and 16 in women), with only a handful of prospective studies. Positive associations between past smoking and nonspecific back pain were reported in five of nine studies in men and five of six studies in women. In addition, increases in the prevalence and/or incidence of nonspecific back pain were found in the majority of studies in which level of consumption was analyzed and reported. An attempt was made to assess whether these results could be artifactual arising from selection bias, confounding bias, publication bias, or errors in measurement. As well, the biologic mechanisms were summarized that have been suggested by various investigators. CONCLUSIONS: The available data are consistent with the notion that smoking is associated with the incidenceand prevalence of nonspecific back pain, but there are too few studies to make any conclusions for the other end points (e.g., sciatica, herniated discs). It cannot be ruled out that the association is a statistical artifact arising from either selection or confounding factors, because the evidence for nonspecific low back pain derives mostly from cross-sectional studies. In addition, it cannot be stated unequivocally that smoking preceded back pain. Long-term follow-up studies are needed to eliminate the possibility that chronic back pain preceded smoking, to better estimate dose-response correlations, and to perform biologic measurements to elucidate possible mechanisms.

Sample size calculations in studies using the EuroQol 5D.

Health-related quality of life (HRQoL) instruments are increasingly used as outcome variables in clinical trials, leading to a requirement for sample size calculations based on these variables. This paper aims to provide a guide to sample size calculations for use with the EuroQol-5D. The paper focuses on sample sizes required for comparative studies, and uses scores from two reference groups of general population and critically ill patients to determine sample sizes using the three parts of the EQ-5D (descriptive system, visual analogue scale (VAS), and EQ-5D index). The effect on sample sizes of different methods of categorising the three variables are compared, and comparisons are also made between sample sizes using parametric and non-parametric methods. Sample sizes required when the EQ-5D descriptive system is used as a binary variable (problems/no problems) are higher than or equal to those required when each dimension is categorised in three levels of severity (no problems, moderate problems, extreme problems). The use of three categories is appropriate in ill populations, though in more healthy populations two categories should be used. Due to the slight skewness of VAS data, and the equality of results using parametric and non-parametric methods, sample size calculations using the VAS should be based on a parametric approach. Sample sizes were considerably higher for the EQ-5D index when predefined intervals, as opposed to a score frequency based categorisation, were used with the general population reference group. Using the EQ-5D index in ill populations, it is recommended that sample size calculations are based on parametric methods, whilst in healthier populations non-parametric methods should be used.

Disablement following stroke.

PURPOSE: Stroke is the most disabling chronic condition, newly affecting 35000 persons in Canada each year. Because of declining fatality, a growing number of persons will have to cope with stroke-related disability. The purpose of this paper is to describe the disabilities experienced by persons with stroke during the first year and explore the evolution of impairment, disability, handicap and health-related quality of life. SUBJECTS: The data for this paper come from a series of longitudinal and cross-sectional studies, collectively known as the McGill Stroke Rehabilitation Research Program. RESULTS: Within the first week post-stroke, getting out of bed and walking over a short distance, even with assistance, was a strong predictor of discharge home. Most of the improvement in measures of impairment and disability occurred during the first month and, by 3 months, there was still considerable room for improvement in all measures: 85% of persons were still impaired on gait speed, 78% had not reached age-specific norms for upper extremity function, 68% still demonstrated slow physical mobility, 37% needed some assistance with basic activities of daily living and 29% were still impaired on balance. By 1 year, 73% of persons scored the maximum for basic activities of daily living but 51 and 67% of persons reported their physical health and mental health to be lower than expected. Among a hardy group of stroke survivors, still living in the community 1 year post-stroke, the most striking area of difficulty was endurance, as measured by the 6 minute walk test. Those subjects well enough to complete this task (50% of sample) were able to walk, on average, only 250 metres, equivalent to 40% of their predicted ability. This series of snapshots taken at different points in time suggests that much of the improvement in impairment and disability occurs during the first month and then reaches a plateau. Handicap and quality of life continue to be issues later. Rehabilitation strategies need to consider the multifaceted nature of disablement, which in itself changes with time post-stroke.

The association between cigarette smoking and back pain in adults.

STUDY DESIGN: A retrospective cohort study of adolescent idiopathic scoliosis. A comparison group of persons without scoliosis was also selected randomly from the general population. OBJECTIVES: To estimate the association between level of cigarette smoking and the prevalence and severity of back pain. METHODS: A postal questionnaire was used to elicit information on smoking histories, a variety of indices of low back pain, and potential confounding factors. The association between smoking and back pain was estimated separately for men and women in the cohort and in the comparison group using ordinal regression models. RESULTS: The questionnaire was completed by 1287 women and 184 men who had adolescent idiopathic scoliosis and by 1130 women and 621 men in the comparison population who did not have scoliosis. Statistically significant associations between back pain and current cigarette smoking were found in the two groups of women and men with scoliosis, but not among men selected from the general population. In the three former groups, proportional odds ratios comparing current smokers to persons who never smoked ranged from 1.4 to 1.9. Among current smokers, the prevalence of back pain increased with cigarette consumption, and the proportional odds ratios ranged from 1.2 to 1.8 per 10 pack-years (no. of cigarettes smoked per day x no. of years/20). In these three groups, intensity, frequency, and duration of episodes of back pain also were found to increase with smoking consumption. CONCLUSION: The finding that smokers have more frequent episodes of back pain may imply that smoking exacerbates back pain, and the observation that stronger associations between back pain and smoking were found in the scoliosis cohort suggests that smoking may have a greater impact on persons with damaged spines.