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1.  The effectiveness of ergonomic interventions on return-to-work after low back pain; a prospective two year cohort study in six countries on low back pain patients sicklisted for 3–4 months 
Aims: To study occurrence and effectiveness of ergonomic interventions on return-to-work applied for workers with low back pain (LBP).
Methods: A multinational cohort of 1631 workers fully sicklisted 3–4 months due to LBP (ICD-9 codes 721, 722, 724) was recruited from sickness benefit claimants databases in Denmark, Germany, Israel, Sweden, the Netherlands, and the United States. Medical, ergonomic, and other interventions, working status, and return-to-work were measured using questionnaires and interviews at three months, one and two years after the start of sickleave. Main outcome measure was time to return-to-work. Cox's proportional hazards model was used to calculate hazard ratios regarding the time to return-to-work, adjusted for prognostic factors.
Results: Ergonomic interventions varied considerably in occurrence between the national cohorts: 23.4% (mean) of the participants reported adaptation of the workplace, ranging from 15.0% to 30.5%. Adaptation of job tasks and adaptation of working hours was applied for 44.8% (range 41.0–59.2%) and 46.0% (range 19.9–62.9%) of the participants, respectively. Adaptation of the workplace was effective on return-to-work rate with an adjusted hazard ratio (HR) of 1.47 (95% CI 1.25 to 1.72; p < 0.0001). Adaptation of job tasks and adaptation of working hours were effective on return-to-work after a period of more than 200 days of sickleave with an adjusted HR of 1.78 (95% CI 1.42 to 2.23; p < 0.0001) and 1.41 (95% CI 1.13 to 1.76; p = 0.002), respectively.
Conclusions: Results suggest that ergonomic interventions are effective on return-to-work of workers long term sicklisted due to LBP.
doi:10.1136/oem.2002.006460
PMCID: PMC1740746  PMID: 15031385
2.  Early coordinated multidisciplinary intervention to prevent sickness absence and labour market exclusion in patients with low back pain: study protocol of a randomized controlled trial 
Background
Musculoskeletal disorders account for one third of the long-term absenteeism in Denmark and the number of individuals sick listed for more than four weeks is increasing. Compared to other diagnoses, patients with musculoskeletal diseases, including low back pain, are less likely to return to work after a period of sick leave. It seems that a multidisciplinary intervention, including cooperation between the health sector, the social sector and in the work place, has a positive effect on days off work due to musculoskeletal disorders and particularly low back pain. It is a challenge to coordinate this type of intervention, and the implementation of a return-to-work (RTW)-coordinator is suggested as an effective strategy in this process. The purpose of this paper is to describe the study protocol and present a new type of intervention, where the physiotherapist both has the role as RTW-coordinator and treating the patient.
Methods/design
A randomized controlled trial (RCT) is currently on-going. The RCT includes 770 patients with low back pain of minimum four weeks who are referred to an outpatient back centre. The study population consists of patients, who are sick-listed or at risk of sick-leave due to LBP. The control group is treated with usual care in a team of a physiotherapist, a chiropractor, a rheumatologist and a social worker employed at the centre. The Intervention group is treated with usual care and in addition intervention of a psychologist, an occupational physician, an ergonomist, a case manager from the municipal sickness benefit office, who has the authority in the actual case concerning sickness benefit payment and contact to the patients employer/work place. The treating physiotherapist is the RTW-coordinator. Outcome will be reported at the end of treatment as well as 6 and 12 months follow up. The primary outcome is number of days off work. Secondary outcomes are disability, pain, and quality of life. The study will follow the recommendations in CONSORT-statement in designing and reporting RCTs.
Discussion
This large RCT is testing the effectiveness of a preventive intervention targeting patients on short term sick leave or at risk being sick listed because of low back pain. We have developed a novel multidisciplinary team structure using the treating physiotherapist as the return to work coordinator, and having the case manager from the municipal sickness benefit office participating in team meetings. The study has the potential to contribute to the knowledge about how to target the challenges in the treatment of LBP. The aim is to prevent sickness absence and labour market exclusion - both on the individual level and economic costs at community level. Short term results will be available in 2014.
This study is approved by the Danish Regional Ethics Committee (J.nr: H-C-2008-112) and is registered at.
Trial registration
ClinicalTrials.gov: NCT01690234
doi:10.1186/1471-2474-14-93
PMCID: PMC3606127  PMID: 23496897
Low back pain (LBP); Return to work (RTW); Sickness absence; Rehabilitation; Prevention; Multidisciplinary intervention; Coordination; Denmark
3.  Prognostic factors for work ability in sicklisted employees with chronic diseases 
Objective
Identifying prognostic factors for work ability in sicklisted employees with myocardial infarction (MI), chronic low back pain (cLBP) and major depressive disorder (MDD) in order to establish an objective basis for work ability evaluation.
Design
Systematic literature search in PubMed database (1 January 1990 to 1 July 2006) with the Yale prognostic research filter. Inclusion criteria were as follows: (1) work-disabled employees; (2) MI, cLBP or MDD patients; (3) longitudinal designs; and (4) return to work or compensation status as outcome measure.
Results
Four studies on MI met the inclusion criteria and described the following prognostic factors for work ability in the acute phase of the disease and disablement: lower age; male gender; no financial basis on which to retire; lower physical job demands; fewer somatic complaints; no anxiety attacks; no diabetes; no heart failure; no atrial fibrillation; no Q waves; and a short time interval between MI and presentation at the occupational medicine clinic. Two studies on cLBP met the inclusion criteria and described the following prognostic factors for work ability after 3 months' work disablement: lower age; male gender; no treatment before sick listing; surgery in the first year of sick listing; being a breadwinner; less pain; better general health; higher job satisfaction; lower physical and/or psychological demands at work; and a higher decision latitude at work. No relevant MDD studies were found.
Conclusion
In the earlier phases of work disablement in MI and cLBP patients, only a few studies describe disease-specific, environmental and personal prognostic factors for return to work. No studies describe prognostic factors for MDD. More evidence is needed on the topic of prognostic factors for return to work in employees with chronic diseases.
doi:10.1136/oem.2006.031807
PMCID: PMC2095362  PMID: 17522133
myocardial infarction; chronic low back pain; major depressive disorder; work ability evaluation; prognostic factors
4.  A qualitative study on the role of cultural background in patients' perspectives on rehabilitation 
Background
Low back pain (LBP) is one of the major concerns in health care. In Switzerland, musculoskeletal problems represent the third largest illness group with 9.4 million consultations per year. The return to work rate is increased by an active treatment program and saves societal costs. However, results after rehabilitation are generally poorer in patients with a Southeast European cultural background than in other patients. This qualitative research about the rehabilitation of patients with LBP and a Southeast European cultural background, therefore, explores possible barriers to successful rehabilitation.
Methods
We used a triangulation of methods combining three qualitative methods of data collection: 13 semi-structured in-depth interviews with patients who have a Southeast European cultural background and live in Switzerland, five semi-structured in-depth interviews and two focus groups with health professionals, and a literature review. Between June and December 2008, we recruited participants at a Rehabilitation Centre in the German-speaking part of Switzerland.
Results
To cope with pain, patients prefer passive strategies, which are not in line with recommended coping strategies. Moreover, the families of patients tend to support passive behaviour and reduce the autonomy of patients. Health professionals and researchers propagate active strategies including activity in the presence of pain, yet patients do not consider psychological factors contributing to LBP. The views of physicians and health professionals are in line with research evidence demonstrating the importance of psychosocial factors for LBP. Treatment goals focusing on increasing daily activities and return to work are not well understood by patients partly due to communication problems, which is something that patients and health professionals are aware of. Additional barriers to returning to work are caused by poor job satisfaction and other work-related factors.
Conclusions
LBP rehabilitation can be improved by addressing the following points. Early management of LBP should be activity-centred instead of pain-centred. It is mandatory to implement return to work management early, including return to adapted work, to improve rehabilitation for patients. Rehabilitation has to start when patients have been off work for three months. Using interpreters more frequently would improve communication between health professionals and patients, and reduce misunderstandings about treatment procedures. Special emphasis must be put on the process of goal-formulation by spending more time with patients in order to identify barriers to goal attainment. Information on the return to work process should also include the financial aspects of unemployment and disability.
doi:10.1186/1471-2474-13-5
PMCID: PMC3398320  PMID: 22269636
5.  Prognosis of acute low back pain: design of a prospective inception cohort study 
Background
Clinical guidelines generally portray acute low back pain as a benign and self-limiting condition. However, evidence about the clinical course of acute low back pain is contradictory and the risk of subsequently developing chronic low back pain remains uncertain. There are few high quality prognosis studies and none that have measured pain, disability and return to work over a 12 month period. This study aims to provide the first estimates of the one year prognosis of acute low back pain (pain of less than 2 weeks duration) in patients consulting primary care practitioners. A secondary aim is to identify factors that are associated with the prognosis of low back pain.
Methods/Design
The study is a prospective inception cohort study. Consecutive patients consulting general medical practitioners, physiotherapists and chiropractors in the Sydney metropolitan region will complete a baseline questionnaire regarding their back pain. Subsequently these patients will be followed up by telephone 6 weeks, 3 months and 12 months after the initial consultation. Patients will be considered to have recovered from the episode of back pain if they have no pain and no limitation of activity, and have returned to pre-injury work status. Life tables will be generated to determine the one year prognosis of acute low back pain. Prognostic factors will be assessed using Cox regression.
Discussion
This study will provide the first estimates of the one year prognosis of acute low back pain in a representative sample of primary care patients.
doi:10.1186/1471-2474-7-54
PMCID: PMC1543628  PMID: 16790069
6.  Artificial Discs for Lumbar and Cervical Degenerative Disc Disease –Update 
Executive Summary
Objective
To assess the safety and efficacy of artificial disc replacement (ADR) technology for degenerative disc disease (DDD).
Clinical Need
Degenerative disc disease is the term used to describe the deterioration of 1 or more intervertebral discs of the spine. The prevalence of DDD is roughly described in proportion to age such that 40% of people aged 40 years have DDD, increasing to 80% among those aged 80 years or older. Low back pain is a common symptom of lumbar DDD; neck and arm pain are common symptoms of cervical DDD. Nonsurgical treatments can be used to relieve pain and minimize disability associated with DDD. However, it is estimated that about 10% to 20% of people with lumbar DDD and up to 30% with cervical DDD will be unresponsive to nonsurgical treatments. In these cases, surgical treatment is considered. Spinal fusion (arthrodesis) is the process of fusing or joining 2 bones and is considered the surgical gold standard for DDD.
Artificial disc replacement is the replacement of the degenerated intervertebral disc with an artificial disc in people with DDD of the lumbar or cervical spine that has been unresponsive to nonsurgical treatments for at least 6 months. Unlike spinal fusion, ADR preserves movement of the spine, which is thought to reduce or prevent the development of adjacent segment degeneration. Additionally, a bone graft is not required for ADR, and this alleviates complications, including bone graft donor site pain and pseudoarthrosis. It is estimated that about 5% of patients who require surgery for DDD will be candidates for ADR.
Review Strategy
The Medical Advisory Secretariat conducted a computerized search of the literature published between 2003 and September 2005 to answer the following questions:
What is the effectiveness of ADR in people with DDD of the lumbar or cervical regions of the spine compared with spinal fusion surgery?
Does an artificial disc reduce the incidence of adjacent segment degeneration (ASD) compared with spinal fusion?
What is the rate of major complications (device failure, reoperation) with artificial discs compared with surgical spinal fusion?
One reviewer evaluated the internal validity of the primary studies using the criteria outlined in the Cochrane Musculoskeletal Injuries Group Quality Assessment Tool. The quality of concealment allocation was rated as: A, clearly yes; B, unclear; or C, clearly no. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to evaluate the overall quality of the body of evidence (defined as 1 or more studies) supporting the research questions explored in this systematic review. A random effects model meta-analysis was conducted when data were available from 2 or more randomized controlled trials (RCTs) and when there was no statistical and or clinical heterogeneity among studies. Bayesian analyses were undertaken to do the following:
Examine the influence of missing data on clinical success rates;
Compute the probability that artificial discs were superior to spinal fusion (on the basis of clinical success rates);
Examine whether the results were sensitive to the choice of noninferiority margin.
Summary of Findings
The literature search yielded 140 citations. Of these, 1 Cochrane systematic review, 1 RCT, and 10 case series were included in this review. Unpublished data from an RCT reported in the grey literature were obtained from the manufacturer of the device. The search also yielded 8 health technology assessments evaluating ADR that are also included in this review.
Six of the 8 health technology assessments concluded that there is insufficient evidence to support the use of either lumbar or cervical ADR. The results of the remaining 2 assessments (one each for lumbar and cervical ADR) led to a National Institute for Clinical Excellence guidance document supporting the safety and effectiveness of lumbar and cervical ADR with the proviso that an ongoing audit of all clinical outcomes be undertaken owing to a lack of long-term outcome data from clinical trials.
Regarding lumbar ADR, data were available from 2 noninferiority RCTs to complete a meta-analysis. The following clinical, health systems, and adverse event outcome measures were synthesized: primary outcome of clinical success, Oswestry Disability Index (ODI) scores, pain VAS scores, patient satisfaction, duration of surgery, amount of blood loss, length of hospital stay, rate of device failure, and rate of reoperation.
The meta-analysis of overall clinical success supported the noninferiority of lumbar ADR compared with spinal fusion at 24-month follow-up. Of the remaining clinical outcome measures (ODI, pain VAS scores, SF-36 scores [mental and physical components], patient satisfaction, and return to work status), only patient satisfaction and scores on the physical component scale of the SF-36 questionnaire were significantly improved in favour of lumbar ADR compared with spinal fusion at 24 months follow-up. Blood loss and surgical time showed statistical heterogeneity; therefore, meta-analysis results are not interpretable. Length of hospital stay was significantly shorter in patients receiving the ADR compared with controls. Neither the number of device failures nor the number of neurological complications at 24 months was statistically significantly different between the ADR and fusion treatment groups. However, there was a trend towards fewer neurological complications at 24 months in the ADR treatment group compared with the spinal fusion treatment group.
Results of the Bayesian analyses indicated that the influence of missing data on the outcome measure of clinical success was minimal. The Bayesian model indicated that the probability for ADR being better than spinal fusion was 79%. The probability of ADR being noninferior to spinal fusion using a -10% noninferiority bound was 92%, and using a -15% noninferiority bound was 94%. The probability of artificial discs being superior to spinal fusion in a future trial was 73%.
Six case series were reviewed, mainly to characterize the rate of major complications for lumbar ADR. The Medical Advisory Secretariat defined a major complication as any reoperation; device failure necessitating a revision, removal or reoperation; or life-threatening event. The rates of major complications ranged from 0% to 13% per device implanted. Only 1 study reported the rate of ASD, which was detected in 2 (2%) of the 100 people 11 years after surgery.
There were no RCT data available for cervical ADR; therefore, data from 4 case series were reviewed for evidence of effectiveness and safety. Because data were sparse, the effectiveness of cervical ADR compared with spinal fusion cannot be determined at this time.
The rate of major complications was assessed up to 2 years after surgery. It was found to range from 0% to 8.1% per device implanted. The rate of ASD is not reported in the clinical trial literature.
The total cost of a lumbar ADR procedure is $15,371 (Cdn; including costs related to the device, physician, and procedure). The total cost of a lumbar fusion surgery procedure is $11,311 (Cdn; including physicians’ and procedural costs).
Conclusions
Lumbar Artificial Disc Replacement
Since the 2004 Medical Advisory Secretariat health technology policy assessment, data from 2 RCTs and 6 case series assessing the effectiveness and adverse events profile of lumbar ADR to treat DDD has become available. The GRADE quality of this evidence is moderate for effectiveness and for short-term (2-year follow-up) complications; it is very low for ASD.
The effectiveness of lumbar ADR is not inferior to that of spinal fusion for the treatment of lumbar DDD. The rates for device failure and neurological complications 2 years after surgery did not differ between ADR and fusion patients. Based on a Bayesian meta-analysis, lumbar ADR is 79% superior to lumbar spinal fusion.
The rate of major complications after lumbar ADR is between 0% and 13% per device implanted. The rate of ASD in 1 case series was 2% over an 11-year follow-up period.
Outcome data for lumbar ADR beyond a 2-year follow-up are not yet available.
Cervical Artificial Disc Replacement
Since the 2004 Medical Advisory Secretariat health technology policy assessment, 4 case series have been added to the body of evidence assessing the effectiveness and adverse events profile of cervical ADR to treat DDD. The GRADE quality of this evidence is very low for effectiveness as well as for the adverse events profile. Sparse outcome data are available.
Because data are sparse, the effectiveness of cervical ADR compared with spinal fusion cannot be determined at this time.
The rate of major complications was assessed up to 2 years after surgery; it ranged from 0% to 8.1% per device implanted. The rate of ASD is not reported in the clinical trial literature.
PMCID: PMC3379529  PMID: 23074480
7.  Randomised controlled trial of exercise for low back pain: clinical outcomes, costs, and preferences 
BMJ : British Medical Journal  1999;319(7205):279-283.
Objective
To evaluate effectiveness of an exercise programme in a community setting for patients with low back pain to encourage a return to normal activities.
Design
Randomised controlled trial of progressive exercise programme compared with usual primary care management. Patients’ preferences for type of management were elicited independently of randomisation.
Participants
187 patients aged 18-60 years with mechanical low back pain of 4 weeks to 6 months’ duration.
Interventions
Exercise classes led by a physiotherapist that included strengthening exercises for all main muscle groups, stretching exercises, relaxation session, and brief education on back care. A cognitive-behavioural approach was used.
Main outcome measures
Assessments of debilitating effects of back pain before and after intervention and at 6 months and 1 year later. Measures included Roland disability questionnaire, Aberdeen back pain scale, pain diaries, and use of healthcare services.
Results
At 6 weeks after randomisation, the intervention group improved marginally more than the control group on the disability questionnaire and reported less distressing pain. At 6 months and 1 year, the intervention group showed significantly greater improvement in the disability questionnaire score (mean difference in changes 1.35, 95% confidence interval 0.13 to 2.57). At 1 year, the intervention group also showed significantly greater improvement in the Aberdeen back pain scale (4.44, 1.01 to 7.87) and reported only 378 days off work compared with 607 in the control group. The intervention group used fewer healthcare resources. Outcome was not influenced by patients’ preferences.
Conclusions
The exercise class was more clinically effective than traditional general practitioner management, regardless of patient preference, and was cost effective.
Key messagesPatients with back pain need to return to normal activities as soon as possible but are often afraid that movement or activity may be harmfulAn exercise programme led by a physiotherapist in the community and based on cognitive-behavioural principles helped patients to cope better with their pain and function better even one year laterPatients’ preferences for type of management did not affect outcomePatients in the intervention group tended to use fewer healthcare resources and took fewer days off workThis type of exercise programme should be more widely available
PMCID: PMC28176  PMID: 10426734
8.  Return to work of cancer survivors: a prospective cohort study into the quality of rehabilitation by occupational physicians 
Aims: To describe and assess the quality of rehabilitation of cancer survivors by occupational physicians and to relate the quality of the process of occupational rehabilitation to the outcome of return to work.
Methods: One hundred occupational physicians of a cohort of cancer survivors were interviewed about return to work management. Quality of rehabilitation was assessed by means of four indicators that related to performance in knowledge of cancer and treatment, continuity of care, patients complaints, and relations at work. The cohort of patients was prospectively followed for 12 months to assess time to return to work and rate of return to work. Patients' and physicians' satisfaction with care was also assessed. The relation between performance and these outcome measures was studied in a multivariate analysis, taking into account the influence of other work and disease related factors that could potentially predict return to work.
Results: For knowledge of cancer and treatment, only 3% had optimal performance because occupational physicians did not communicate with treating physicians. For continuity of care, patient complaints, and relations at work, performance was optimal for 55%, 78%, and 60% of the physicians respectively. After adjustment for other prognostic factors, overall physician's performance (hazard ratio (HR) 0.5, 95% CI 0.3 to 0.8) and continuity of care (HR 0.5, 95% CI 0.3 to 0.9) were related to the return to work of patients. Overall optimal performance was also related to a small but significant higher level of satisfaction with care, both for patients and physicians.
Conclusion: Quality of occupational rehabilitation of cancer survivors can be improved substantially, especially with regard to communication between physicians and continuity of care. There is a need for the development of more effective rehabilitation procedures which should be evaluated in a randomised controlled trial.
doi:10.1136/oem.60.5.352
PMCID: PMC1740540  PMID: 12709521
9.  Risk factors for sickness absence due to low back pain and prognostic factors for return to work in a cohort of shipyard workers 
European Spine Journal  2008;17(9):1185-1192.
The purpose of this study was to determine risk factors for the occurrence of sickness absence due to low back pain (LBP) and to evaluate prognostic factors for return to work. A longitudinal study with 1-year follow-up was conducted among 853 shipyard workers. The cohort was drawn around January 2004 among employees in the shipyard industry. Baseline information was obtained by questionnaire on physical and psychosocial work load, need for recovery, perceived general health, musculoskeletal complaints, sickness absence, and health care use during the past year. During the 1-year follow-up for each subject medical certifications were retrieved for information on the frequency and duration of spells of sickness absence and associated diagnoses. Cox regression analyses were conducted on occurrence and on duration of sickness absence with hazard ratios (HR) with 95% confidence interval (95% CI) as measure of association. During the 1-year follow-up period, 14% of the population was on sick leave at least once with LBP while recurrence reached 41%. The main risk factors for sickness absence were previous absence due to a health problem other than LBP (HR 3.07; 95%CI 1.66–5.68) or previous sickness absence due to LBP (HR 6.52; 95%CI 3.16–13.46). Care seeking for LBP and lower educational level also hold significant influences (HR 2.41; 95%CI 1.45–4.01 and HR 2.46; 95%CI 1.19–5.07, respectively). Living with others, night shift and supervising duties were associated with less absenteeism due to LBP. Workers with a history of herniated disc had a significantly decreased rate of returning to work, whereas those who suffered from hand-wrist complaints and LBP returned to work faster. Prior sick leave due to LBP partly captured the effects of work-related physical and psychosocial factors on occurrence of sick leave. Our study showed that individual and job characteristics (living alone, night shift, lower education, sick leave, or care seeking during the last 12 months) influenced the decision to take sick leave due to LBP. An increased awareness of those frequently on sick leave and additional management after return to work may have a beneficial effect on the sickness absence pattern.
doi:10.1007/s00586-008-0711-0
PMCID: PMC2527417  PMID: 18649089
Low back pain; Sick leave; Prognosis; Recurrence; Return to work
10.  Expectations for Recovery Important in the Prognosis of Whiplash Injuries 
PLoS Medicine  2008;5(5):e105.
Background
Individuals' expectations on returning to work after an injury have been shown to predict the duration of time that a person with work-related low back pain will remain on benefits; individuals with lower recovery expectations received benefits for a longer time than those with higher expectations. The role of expectations in recovery from traumatic neck pain, in particular whiplash-associated disorders (WAD), has not been assessed to date to our knowledge. The aim of this study was to investigate if expectations for recovery are a prognostic factor after experiencing a WAD.
Methods and Findings
We used a prospective cohort study composed of insurance claimants in Sweden. The participants were car occupants who filed a neck injury claim (i.e., for WAD) to one of two insurance companies between 15 January 2004 and 12 January 2005 (n = 1,032). Postal questionnaires were completed shortly (average 23 d) after the collision and then again 6 mo later. Expectations for recovery were measured with a numerical rating scale (NRS) at baseline, where 0 corresponds to “unlikely to make a full recovery” and 10 to “very likely to make a full recovery.” The scale was reverse coded and trichotomised into NRS 0, 1–4, and 5–10. The main outcome measure was self-perceived disability at 6 mo postinjury, measured with the Pain Disability Index, and categorised into no/low, moderate, and high disability. Multivariable polytomous logistic regression was used for the analysis. There was a dose response relationship between recovery expectations and disability. After controlling for severity of physical and mental symptoms, individuals who stated that they were less likely to make a full recovery (NRS 5–10), were more likely to have a high disability compared to individuals who stated that they were very likely to make a full recovery (odds ratio [OR] 4.2 [95% confidence interval (CI) 2.1 to 8.5]. For the intermediate category (NRS 1–4), the OR was 2.1 (95% CI 1.2 to 3.2). Associations between expectations and disability were also found among individuals with moderate disability.
Conclusions
Individuals' expectations for recovery are important in prognosis, even after controlling for symptom severity. Interventions designed to increase patients' expectations may be beneficial and should be examined further in controlled studies.
Lena Holm and colleagues show that in people who had a whiplash injury after a car crash there was an association between expectation of disability and actual disability six months later.
Editors' Summary
Background
The disability associated with injury is a major source of distress for patients, and can be costly to the health care system and employers when persons fail to recover quickly and are unable to return to work. Finding ways to help people recover quickly and get back to optimal health is important. Some of the most common injuries causing disability and time off work result from whiplash—the sudden hyperextension or “whipping” of the neck, which can occur from a motor vehicle crash. It has long been recognized that psychological factors (such as the ability to cope, how “in control” one feels about one's life) are as important as physical symptoms in how disabling an injury can be. There is now growing evidence that a person's feelings about their ability to recover from injury plays a part in actual recovery. Studies from Europe and North America have shown with conditions like low back pain and minor head injury that a patient's feelings about the possibility of getting better are related to how well they do. Less is known about how important these psychological factors are in recovery from disorders due to whiplash associated disorders.
Why Was This Study Done?
The authors wanted to find out whether there was a relationship between people's expectations for their recovery from whiplash associated disorders and their actual recovery six months later. So, for example, they wondered if a person with whiplash who felt they were very unlikely to recover from their injury, actually did not recover (and vice versa).
What Did the Researchers Do and Find?
The authors had access to an unusual set of health information—insurance claims by people who had been involved in car collisions to two insurance companies in Sweden. They identified about 1,000 adult insurance claimants over one year and mailed them a questionnaire that asked for details about the collision as well as information about the claimant: their demographic profile, health history, and the types of pain and symptoms experienced since the crash. The questionnaire also asked the claimant how likely they thought they were to make a full recovery from their injuries.
For those who said they had whiplash associated disorders, the authors followed up with another questionnaire six months later, which asked for information about any disability, pain, or other symptoms that the claimant was still experiencing because of the injury. Of those who had completed the first questionnaire, 82% were followed up.
Only about a quarter of claimants with whiplash associated disorders said they expected to make a full recovery. Perhaps not surprisingly, those with only mild pain, compared to those with intense pain, were more likely to think so. Persons who said they were less likely to make a full recovery were four times more likely to report high levels of disability six months later. Even for persons (or individuals) people with moderate levels of disability six months after injury, their expectations for recovery were similarly linked to how well they did: the lower the expectations for recovery, the higher the disability. These findings were true even after taking into account how severe signs and symptoms the person had, and how well the person was coping psychologically.
What Do These Findings Mean?
The findings indicate that those with the lowest expectations for recovery after their whiplash injury will have the poorest recovery, and those with the highest expectations will have the best recovery. They also suggest that a patient's expectations about getting better are as important as his or her physical symptoms. The authors say that the more we can influence patients to believe they will make a full recovery, the better chance they will have to recover completely. This means that it may be beneficial for healthcare providers to give support and/or education to patients with whiplash associated disorders that increases their positive feelings toward recovery. The authors call for more studies into whether these types of targeted interventions would be of benefit.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050105.
Information about research on injuries and rehabilitation can be found at the Web sites of organisations devoted to studying the health of workers, such as the Institute for Work and Health in Canada, the Finnish Institute of Occupational Health, and the US National Institute for Occupational Safety and Health
The Wikipedia entry for medical aspects of whiplash describes the four grades of whiplash disorder, but does not cover the debate about the credibility of whiplash disorder (please note that Wikipedia is an online encyclopedia that anyone can edit)
The Sjukvardsradgivningen Web site provides information about whiplash-related disorders, common signs and symptoms, recovery and prognosis, and treatments (in Swedish)
doi:10.1371/journal.pmed.0050105
PMCID: PMC2375948  PMID: 18479182
11.  Prognosis in patients with recent onset low back pain in Australian primary care: inception cohort study 
Objective To estimate the one year prognosis and identify prognostic factors in cases of recent onset low back pain managed in primary care.
Design Cohort study with one year follow-up.
Setting Primary care clinics in Sydney, Australia.
Participants An inception cohort of 973 consecutive primary care patients (mean age 43.3, 54.8% men) with non-specific low back pain of less than two weeks’ duration recruited from the clinics of 170 general practitioners, physiotherapists, and chiropractors.
Main outcome measures Participants completed a baseline questionnaire and were contacted six weeks, three months, and 12 months after the initial consultation. Recovery was assessed in terms of return to work, return to function, and resolution of pain. The association between potential prognostic factors and time to recovery was modelled with Cox regression.
Results The follow-up rate over the 12 months was more than 97%. Half of those who reduced their work status at baseline had returned to previous work status within 14 days (95% confidence interval 11 to 17 days) and 83% had returned to previous work status by three months. Disability (median recovery time 31 days, 25 to 37 days) and pain (median 58 days, 52 to 63 days) took much longer to resolve. Only 72% of participants had completely recovered 12 months after the baseline consultation. Older age, compensation cases, higher pain intensity, longer duration of low back pain before consultation, more days of reduced activity because of lower back pain before consultation, feelings of depression, and a perceived risk of persistence were each associated with a longer time to recovery.
Conclusions In this cohort of patients with acute low back pain in primary care, prognosis was not as favourable as claimed in clinical practice guidelines. Recovery was slow for most patients. Nearly a third of patients did not recover from the presenting episode within a year.
doi:10.1136/bmj.a171
PMCID: PMC2483884  PMID: 18614473
12.  Prognosis in patients with recent onset low back pain in Australian primary care: inception cohort study 
BMJ : British Medical Journal  2008;337(7662):154-157.
Objective To estimate the one year prognosis and identify prognostic factors in cases of recent onset low back pain managed in primary care.
Design Cohort study with one year follow-up.
Setting Primary care clinics in Sydney, Australia.
Participants An inception cohort of 973 consecutive primary care patients (mean age 43.3, 54.8% men) with non-specific low back pain of less than two weeks’ duration recruited from the clinics of 170 general practitioners, physiotherapists, and chiropractors.
Main outcome measures Participants completed a baseline questionnaire and were contacted six weeks, three months, and 12 months after the initial consultation. Recovery was assessed in terms of return to work, return to function, and resolution of pain. The association between potential prognostic factors and time to recovery was modelled with Cox regression.
Results The follow-up rate over the 12 months was more than 97%. Half of those who reduced their work status at baseline had returned to previous work status within 14 days (95% confidence interval 11 to 17 days) and 83% had returned to previous work status by three months. Disability (median recovery time 31 days, 25 to 37 days) and pain (median 58 days, 52 to 63 days) took much longer to resolve. Only 72% of participants had completely recovered 12 months after the baseline consultation. Older age, compensation cases, higher pain intensity, longer duration of low back pain before consultation, more days of reduced activity because of lower back pain before consultation, feelings of depression, and a perceived risk of persistence were each associated with a longer time to recovery.
Conclusions In this cohort of patients with acute low back pain in primary care, prognosis was not as favourable as claimed in clinical practice guidelines. Recovery was slow for most patients. Nearly a third of patients did not recover from the presenting episode within a year.
doi:10.1136/bmj.a171
PMCID: PMC2483884  PMID: 18614473
13.  Faster return to work after psychiatric consultation for sicklisted employees with common mental disorders compared to care as usual. A randomized clinical trial 
Introduction
Return to work (RTW) of employees on sick leave for common mental disorders may require a multidisciplinary approach. This article aims to assess time to RTW after a psychiatric consultation providing treatment advice to the occupational physician (OP) for employees on sick leave for common mental disorders in the occupational health (OH) setting, compared to care as usual (CAU).
Methods
Cluster randomized clinical trial evaluating patients of 12 OPs receiving consultation by a psychiatrist, compared to CAU delivered by 12 OPs in the control group. 60 patients suffering from common mental disorders and ≥ six weeks sicklisted were included. Follow up three and six months after inclusion. Primary outcome measure was time to RTW. Intention- to-treat multilevel analysis and a survival analysis were performed to evaluate time to RTW in both groups.
Results
In CAU, referral was the main intervention. Both groups improved in terms of symptom severity and quality of life, but time to RTW was significantly shorter in the psychiatric consultation group. At three months follow up, 58% of the psychiatric consultation group had full RTW versus 44% of the control group, a significant finding (P = 0.0093). Survival analysis showed 68 days earlier RTW after intervention in the psychiatric consultation group (P = 0.078) compared to CAU.
Conclusion
Psychiatric consultation for employees on sick leave in the OH setting improves time to RTW in patients with common mental disorders as compared to CAU. In further research, focus should be on early intervention in patients with common mental disorders on short sick leave duration. Psychiatric consultation might be particularly promising for improvement of RTW in those patients.
Trial registration number
ISRCTN: 86722376
PMCID: PMC2938286  PMID: 20856601
psychiatric consultation; mental disorders; RCT; sickness absence; major depressive disorder; anxiety disorder; somatoform disorder
14.  Spinal cord stimulation for predominant low back pain in failed back surgery syndrome: study protocol for an international multicenter randomized controlled trial (PROMISE study) 
Trials  2013;14:376.
Background
Although results of case series support the use of spinal cord stimulation in failed back surgery syndrome patients with predominant low back pain, no confirmatory randomized controlled trial has been undertaken in this patient group to date. PROMISE is a multicenter, prospective, randomized, open-label, parallel-group study designed to compare the clinical effectiveness of spinal cord stimulation plus optimal medical management with optimal medical management alone in patients with failed back surgery syndrome and predominant low back pain.
Method/Design
Patients will be recruited in approximately 30 centers across Canada, Europe, and the United States. Eligible patients with low back pain exceeding leg pain and an average Numeric Pain Rating Scale score ≥5 for low back pain will be randomized 1:1 to spinal cord stimulation plus optimal medical management or to optimal medical management alone. The investigators will tailor individual optimal medical management treatment plans to their patients. Excluded from study treatments are intrathecal drug delivery, peripheral nerve stimulation, back surgery related to the original back pain complaint, and experimental therapies. Patients randomized to the spinal cord stimulation group will undergo trial stimulation, and if they achieve adequate low back pain relief a neurostimulation system using the Specify® 5-6-5 multi-column lead (Medtronic Inc., Minneapolis, MN, USA) will be implanted to capture low back pain preferentially in these patients. Outcome assessment will occur at baseline (pre-randomization) and at 1, 3, 6, 9, 12, 18, and 24 months post randomization. After the 6-month visit, patients can change treatment to that received by the other randomized group. The primary outcome is the proportion of patients with ≥50% reduction in low back pain at the 6-month visit. Additional outcomes include changes in low back and leg pain, functional disability, health-related quality of life, return to work, healthcare utilization including medication usage, and patient satisfaction. Data on adverse events will be collected. The primary analysis will follow the intention-to-treat principle. Healthcare use data will be used to assess costs and long-term cost-effectiveness.
Discussion
Recruitment began in January 2013 and will continue until 2016.
Trial registration
Clinicaltrials.gov: NCT01697358 (http://www.clinicaltrials.gov)
doi:10.1186/1745-6215-14-376
PMCID: PMC4226255  PMID: 24195916
Low back pain; Neuropathic pain; Failed back surgery syndrome; Spinal cord stimulation; Randomized controlled trial
15.  Non-specific low back pain in primary care in the Spanish National Health Service: a prospective study on clinical outcomes and determinants of management 
Background
The Spanish National Health Service is a universal and free health care system. Non-specific low back pain (LBP) is a prevalent disorder, generating large health and social costs. The objectives of this study were to describe its management in primary care, to assess patient characteristics that influence physicians' decisions, and to describe clinical outcome at 2 months.
Methods
A cross-sectional sample of 648 patients with non-specific low back pain was recruited by 75 physicians (out of 361 – 20.8%) working in 40 primary care centers in 10 of the 17 administrative regions in Spain, covering 693,026 out of the 40,499,792 inhabitants. Patients were assessed on the day they were recruited, and prospectively followed-up 14 and 60 days later. The principal patient characteristics that were analyzed were: sex, duration of the episode, history of LBP, working status, severity of LBP, leg pain and disability, and results of straight leg raising test. Descriptors of management were: performance of the straight leg raising test, ordering of diagnostic procedures, prescription of drug treatment, referral to physical therapy, rehabilitation or surgery, and granting of sick leave. Regression analysis was used to analyze the relationship between patients' baseline characteristics and physicians' management decisions. Only workers were included in the models on sick leave.
Results
Mean age (SD) of included patients was 46.5 (15.5) years, 367 (56.6%) were workers, and 338 (52.5%) were females. Median (25th–75th interquartile range) duration of pain when entering the study was 4 (2–10) days and only 28 patients (4.3%) had chronic low back pain. Diagnostic studies included plain radiographs in 43.1% of patients and CT or MRI scans in 18.8%. Drug medication was prescribed to 91.7% of patients, 19.1% were sent to physical therapy or rehabilitation, and 9.6% were referred to surgery. The main determinants of the clinical management were duration of the episode and, to a lesser extent, the intensity of the pain (especially leg pain), a positive straight leg raising test, and degree of disability. The main determinant of sick leave was the degree of disability, followed by the characteristics of the labor contract and the intensity of leg pain (but not low back pain). After at least 2 months of treatment, 37% of patients were still in pain and approximately 10% of patients had not improved or had worsened.
Conclusion
Although the use of X-Rays is high, determinants of physicians' management of LBP in primary care made clinical sense and were consistent with patterns suggested by evidence-based recommendations. However, after 2 months of treatment more than one third of patients continued to have back pain and about 10% had worsened.
doi:10.1186/1472-6963-6-57
PMCID: PMC1479820  PMID: 16707005
16.  Long-term return to work after a functional restoration program for chronic low-back pain patients: a prospective study 
European Spine Journal  2010;19(7):1153-1161.
Low-back pain is a major health and socio economic problem. Functional restoration programs (FRP) have been developed to promote the socio-professional reintegration of patients with important work absenteeism. The aim of this study was to determine the long-term effectiveness of FRP in a group of 105 chronic low-back pain patients and to determine the predictive factors of return to work. One hundred-and-five chronic LBP patients with over 1 month of work absenteeism were included in a FRP. Pain, professional status, quality of life, functional disability, psychological impact, and fear and avoidance beliefs were evaluated at baseline, after 1 year and at the end of follow-up. Main effectiveness criterion was return to work. Fifty-five percent of the patients returned to work after mean follow-up time of 3.5 years, compared with 9% of the patients at work at baseline. Quality of life, functional disability, psychological factors, and fear and avoidance beliefs were all significantly improved. Three predictive factors were found: younger age at the onset of low-back pain, practice of sports, and shorter duration of sick leave at baseline. FRP show positive results in terms of return to work for chronic LBP patients with prolonged work absenteeism. Efforts should be made to propose such programs at an earlier stage of the disease.
doi:10.1007/s00586-010-1361-6
PMCID: PMC2900022  PMID: 20224867
Chronic low-back pain; Functional restoration program; Return to work
17.  A Novel Tool for the Assessment of Pain: Validation in Low Back Pain 
PLoS Medicine  2009;6(4):e1000047.
Joachim Scholz and colleagues develop and validate an assessment tool that distinguishes between radicular and axial low back pain.
Background
Adequate pain assessment is critical for evaluating the efficacy of analgesic treatment in clinical practice and during the development of new therapies. Yet the currently used scores of global pain intensity fail to reflect the diversity of pain manifestations and the complexity of underlying biological mechanisms. We have developed a tool for a standardized assessment of pain-related symptoms and signs that differentiates pain phenotypes independent of etiology.
Methods and Findings
Using a structured interview (16 questions) and a standardized bedside examination (23 tests), we prospectively assessed symptoms and signs in 130 patients with peripheral neuropathic pain caused by diabetic polyneuropathy, postherpetic neuralgia, or radicular low back pain (LBP), and in 57 patients with non-neuropathic (axial) LBP. A hierarchical cluster analysis revealed distinct association patterns of symptoms and signs (pain subtypes) that characterized six subgroups of patients with neuropathic pain and two subgroups of patients with non-neuropathic pain. Using a classification tree analysis, we identified the most discriminatory assessment items for the identification of pain subtypes. We combined these six interview questions and ten physical tests in a pain assessment tool that we named Standardized Evaluation of Pain (StEP). We validated StEP for the distinction between radicular and axial LBP in an independent group of 137 patients. StEP identified patients with radicular pain with high sensitivity (92%; 95% confidence interval [CI] 83%–97%) and specificity (97%; 95% CI 89%–100%). The diagnostic accuracy of StEP exceeded that of a dedicated screening tool for neuropathic pain and spinal magnetic resonance imaging. In addition, we were able to reproduce subtypes of radicular and axial LBP, underscoring the utility of StEP for discerning distinct constellations of symptoms and signs.
Conclusions
We present a novel method of identifying pain subtypes that we believe reflect underlying pain mechanisms. We demonstrate that this new approach to pain assessment helps separate radicular from axial back pain. Beyond diagnostic utility, a standardized differentiation of pain subtypes that is independent of disease etiology may offer a unique opportunity to improve targeted analgesic treatment.
Editors' Summary
Background
Pain, although unpleasant, is essential for survival. Whenever the body is damaged, nerve cells detecting the injury send an electrical message via the spinal cord to the brain and, as a result, action is taken to prevent further damage. Usually pain is short-lived, but sometimes it continues for weeks, months, or years. Long-lasting (chronic) pain can be caused by an ongoing, often inflammatory condition (for example, arthritis) or by damage to the nervous system itself—experts call this “neuropathic” pain. Damage to the brain or spinal cord causes central neuropathic pain; damage to the nerves that convey information from distant parts of the body to the spinal cord causes peripheral neuropathic pain. One example of peripheral neuropathic pain is “radicular” low back pain (also called sciatica). This is pain that radiates from the back into the legs. By contrast, axial back pain (the most common type of low back pain) is confined to the lower back and is non-neuropathic.
Why Was This Study Done?
Chronic pain is very common—nearly 10% of American adults have frequent back pain, for example—and there are many treatments for it, including rest, regulated exercise (physical therapy), pain-killing drugs (analgesics), and surgery. However, the best treatment for any individual depends on the exact nature of their pain, so it is important to assess their pain carefully before starting treatment. This is usually done by scoring overall pain intensity, but this assessment does not reflect the characteristics of the pain (for example, whether it occurs spontaneously or in response to external stimuli) or the complex biological processes involved in pain generation. An assessment designed to take such factors into account might improve treatment outcomes and could be useful in the development of new therapies. In this study, the researchers develop and test a new, standardized tool for the assessment of chronic pain that, by examining many symptoms and signs, aims to distinguish between pain subtypes.
What Did the Researchers Do and Find?
One hundred thirty patients with several types of peripheral neuropathic pain and 57 patients with non-neuropathic (axial) low back pain completed a structured interview of 16 questions and a standardized bedside examination of 23 tests. Patients were asked, for example, to choose words that described their pain from a list provided by the researchers and to grade the intensity of particular aspects of their pain from zero (no pain) to ten (the maximum imaginable pain). Bedside tests included measurements of responses to light touch, pinprick, and vibration—chronic pain often alters responses to harmless stimuli. Using “hierarchical cluster analysis,” the researchers identified six subgroups of patients with neuropathic pain and two subgroups of patients with non-neuropathic pain based on the patterns of symptoms and signs revealed by the interviews and physical tests. They then used “classification tree analysis” to identify the six questions and ten physical tests that discriminated best between pain subtypes and combined these items into a tool for a Standardized Evaluation of Pain (StEP). Finally, the researchers asked whether StEP, which took 10–15 minutes, could identify patients with radicular back pain and discriminate them from those with axial back pain in an independent group of 137 patients with chronic low back pain. StEP, they report, accurately diagnosed these two conditions and was well accepted by the patients.
What Do These Findings Mean?
These findings indicate that a standardized assessment of pain-related signs and symptoms can provide a simple, quick diagnostic procedure that distinguishes between radicular (neuropathic) and axial (non-neuropathic) low back pain. This distinction is crucial because these types of back pain are best treated in different ways. In addition, the findings suggest that it might be possible to identify additional pain subtypes using StEP. Because these subtypes may represent conditions in which different pain mechanisms are acting, classifying patients in this way might eventually enable physicians to tailor treatments for chronic pain to the specific needs of individual patients rather than, as at present, largely guessing which of the available treatments is likely to work best.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000047.
This study is further discussed in a PLoS Medicine Perspective by Giorgio Cruccu and and Andrea Truini
The US National Institute of Neurological Disorders and Stroke provides a primer on pain in English and Spanish
In its 2006 report on the health status of the US, the National Center for Health Statistics provides a special feature on the epidemiology of pain, including back pain
The Pain Treatment Topics Web site is a resource, sponsored partly by associations and manufacturers, that provides information on all aspects of pain and its treatment for health care professionals and their patients
Medline Plus provides a brief description of pain and of back pain and links to further information on both topics (in English and Spanish)
The MedlinePlus Medical Encyclopedia also has a page on low back pain (in English and Spanish)
doi:10.1371/journal.pmed.1000047
PMCID: PMC2661253  PMID: 19360087
18.  Clinical course and prognostic factors in acute low back pain: an inception cohort study in primary care practice. 
BMJ : British Medical Journal  1994;308(6928):577-580.
OBJECTIVE--To describe the natural course of recent acute low back pain in terms of both morbidity (pain, disability) and absenteeism from work and to evaluate the prognostic factors for these outcomes. DESIGN--Inception cohort study. SETTING--Primary care. PATIENTS--103 patients with acute localised non-specific back pain lasting less than 72 hours. MAIN OUTCOME MEASURES--Complete recovery (disappearance of both pain and disability) and return to work. RESULTS--90% of patients recovered within two weeks and only two developed chronic low back pain. Only 49 of 100 patients for whom data were available had bed rest and 40% of 75 employed patients lost no time from work. Proportional hazards regression analysis showed that previous chronic episodes of low back pain, initial disability level, initial pain worse when standing, initial pain worse when lying, and compensation status were significantly associated with delayed episode recovery. These factors were also related to absenteeism from work. Absenteeism from work was also influenced by job satisfaction and gender. CONCLUSIONS--The recovery rate from acute low back pain was much higher than reported in other studies. Those studies, however, did not investigate groups of patients enrolled shortly after the onset of symptoms and often mixed acute low back pain patients with patients with exacerbations of chronic pain or sciatica. Several sociodemographic and clinical factors were of prognostic value in acute low back pain. Factors which influenced the outcome in terms of episode recovery (mainly physical severity factors) were only partly predictive of absenteeism from work. Time off work and return to work depended more on sociodemographic and job related influences.
PMCID: PMC2539597  PMID: 8148683
19.  Recurrence of Work-Related Low Back Pain and Disability 
Spine  2013;38(26):2279-2286.
Supplemental Digital Content is Available in the Text.
Workers' compensation claimants (N = 90) were interviewed about their post-return-to-work low back pain (LBP) experiences. Interview data were linked with wage-replacement (WR) data and compared for concordance. Although WR-based indicators were found to relate to self-reports of additional time off, no signifi cant relationship was observed when the best performing WR-based indicator was compared with other self-report indicators of LBP recurrence.
Study Design.
Retrospective cohort.
Objective.
To explore the ability to capture low back pain (LBP) recurrence using wage-replacement (WR) data.
Summary of Background Data.
LBP can be a recurrent, fluctuating, and disabling condition. Because of its largely nonspecific and subjective nature, the condition poses challenges for research and clinical management, as speaking directly with the affected individuals is not always practical. Little information is available on how indicators of LBP recurrence that can be extracted from administrative databases relate to patients' self-report.
Methods.
Participants with a compensated claim for work-related LBP (N = 90) were interviewed regarding their LBP-related experiences after their initial return to work. Interview data were compared with WR data, which was provided by the participants' workers' compensation provider.
Results.
Concordance was observed between WR-based indicators and self-reports of additional time off due to LBP. The best performing WR-based indicator reflected a payment history that began with more than 7 consecutive days of initial WR payments, followed by a gap in WR payments of more than 7 consecutive days, followed by another WR payment period of more than 7 consecutive days (sensitivity = 55%, specificity = 73%, overall accuracy = 69%). Although concordance was observed between the 2 measures of additional time off, the best performing WR indicator was not related to participants' other self-reports of post–return-to-work LBP recurrence which included LBP being significantly worse usual; LBP experiences; seeking health care for LBP; and the experience of difficulties related to the back condition.
Conclusion.
Results indicate that compensation data can be used to capture what a claimant would self-report as additional time off after their initial return to work due to their LBP condition. However, the use of self-report recurrence indicators is recommended if there is a desire to capture a fuller extent of workers' ongoing pain and/or disability experiences.
Level of Evidence: N/A
doi:10.1097/BRS.0000000000000016
PMCID: PMC4047308  PMID: 24048092
low back pain; workers' compensation; recurrence; administrative data; wage-replacement benefits; self-report
20.  Cost-effectiveness of a participatory return-to-work intervention for temporary agency workers and unemployed workers sick-listed due to musculoskeletal disorders: design of a randomised controlled trial 
Background
Within the working population there is a vulnerable group: workers without an employment contract and workers with a flexible labour market arrangement, e.g. temporary agency workers. In most cases, when sick-listed, these workers have no workplace/employer to return to. Also, for these workers access to occupational health care is limited or even absent in many countries. For this vulnerable working population there is a need for tailor-made occupational health care, including the presence of an actual return-to-work perspective. Therefore, a participatory return-to-work program has been developed based on a successful return-to-work intervention for workers, sick-listed due to low back pain.
The objective of this paper is to describe the design of a randomised controlled trial to study the (cost-)effectiveness of this newly developed participatory return-to-work program adapted for temporary agency workers and unemployed workers, sick-listed due to musculoskeletal disorders, compared to usual care.
Methods/Design
The design of this study is a randomised controlled trial with one year of follow-up. The study population consists of temporary agency workers and unemployed workers sick-listed between 2 and 8 weeks due to musculoskeletal disorders. The new return-to-work program is a stepwise program aimed at making a consensus-based return-to-work implementation plan with the possibility of a (therapeutic) workplace to return-to-work. Outcomes are measured at baseline, 3, 6, 9 and 12 months. The primary outcome measure is duration of the sickness benefit period after the first day of reporting sick. Secondary outcome measures are: time until first return-to-work, total number of days of sickness benefit during follow-up; functional status; intensity of musculoskeletal pain; pain coping; and attitude, social influence and self-efficacy determinants. Cost-benefit is evaluated from an insurer's perspective. A process evaluation is part of this study.
Discussion
For sick-listed workers without an employment contract there can be gained a lot by improving occupational health care, including return-to-work guidance, and by minimising the 'labour market handicap' by creating a return-to-work perspective. In addition, reduction of sickness absence and work disability, i.e. a reduction of disability claims, may result in substantial benefits for the Dutch Social Security System.
Trial registration
Trial registration number: NTR1047.
doi:10.1186/1471-2474-11-60
PMCID: PMC2858719  PMID: 20346183
21.  Implementing the 2009 Institute of Medicine recommendations on resident physician work hours, supervision, and safety 
Long working hours and sleep deprivation have been a facet of physician training in the US since the advent of the modern residency system. However, the scientific evidence linking fatigue with deficits in human performance, accidents and errors in industries from aeronautics to medicine, nuclear power, and transportation has mounted over the last 40 years. This evidence has also spawned regulations to help ensure public safety across safety-sensitive industries, with the notable exception of medicine.
In late 2007, at the behest of the US Congress, the Institute of Medicine embarked on a year-long examination of the scientific evidence linking resident physician sleep deprivation with clinical performance deficits and medical errors. The Institute of Medicine’s report, entitled “Resident duty hours: Enhancing sleep, supervision and safety”, published in January 2009, recommended new limits on resident physician work hours and workload, increased supervision, a heightened focus on resident physician safety, training in structured handovers and quality improvement, more rigorous external oversight of work hours and other aspects of residency training, and the identification of expanded funding sources necessary to implement the recommended reforms successfully and protect the public and resident physicians themselves from preventable harm.
Given that resident physicians comprise almost a quarter of all physicians who work in hospitals, and that taxpayers, through Medicare and Medicaid, fund graduate medical education, the public has a deep investment in physician training. Patients expect to receive safe, high-quality care in the nation’s teaching hospitals. Because it is their safety that is at issue, their voices should be central in policy decisions affecting patient safety. It is likewise important to integrate the perspectives of resident physicians, policy makers, and other constituencies in designing new policies. However, since its release, discussion of the Institute of Medicine report has been largely confined to the medical education community, led by the Accreditation Council for Graduate Medical Education (ACGME).
To begin gathering these perspectives and developing a plan to implement safer work hours for resident physicians, a conference entitled “Enhancing sleep, supervision and safety: What will it take to implement the Institute of Medicine recommendations?” was held at Harvard Medical School on June 17–18, 2010. This White Paper is a product of a diverse group of 26 representative stakeholders bringing relevant new information and innovative practices to bear on a critical patient safety problem. Given that our conference included experts from across disciplines with diverse perspectives and interests, not every recommendation was endorsed by each invited conference participant. However, every recommendation made here was endorsed by the majority of the group, and many were endorsed unanimously. Conference members participated in the process, reviewed the final product, and provided input before publication. Participants provided their individual perspectives, which do not necessarily represent the formal views of any organization.
In September 2010 the ACGME issued new rules to go into effect on July 1, 2011. Unfortunately, they stop considerably short of the Institute of Medicine’s recommendations and those endorsed by this conference. In particular, the ACGME only applied the limitation of 16 hours to first-year resident physicans. Thus, it is clear that policymakers, hospital administrators, and residency program directors who wish to implement safer health care systems must go far beyond what the ACGME will require. We hope this White Paper will serve as a guide and provide encouragement for that effort.
Resident physician workload and supervision
By the end of training, a resident physician should be able to practice independently. Yet much of resident physicians’ time is dominated by tasks with little educational value. The caseload can be so great that inadequate reflective time is left for learning based on clinical experiences. In addition, supervision is often vaguely defined and discontinuous. Medical malpractice data indicate that resident physicians are frequently named in lawsuits, most often for lack of supervision. The recommendations are: The ACGME should adjust resident physicians workload requirements to optimize educational value. Resident physicians as well as faculty should be involved in work redesign that eliminates nonessential and noneducational activity from resident physician dutiesMechanisms should be developed for identifying in real time when a resident physician’s workload is excessive, and processes developed to activate additional providersTeamwork should be actively encouraged in delivery of patient care. Historically, much of medical training has focused on individual knowledge, skills, and responsibility. As health care delivery has become more complex, it will be essential to train resident and attending physicians in effective teamwork that emphasizes collective responsibility for patient care and recognizes the signs, both individual and systemic, of a schedule and working conditions that are too demanding to be safeHospitals should embrace the opportunities that resident physician training redesign offers. Hospitals should recognize and act on the potential benefits of work redesign, eg, increased efficiency, reduced costs, improved quality of care, and resident physician and attending job satisfactionAttending physicians should supervise all hospital admissions. Resident physicians should directly discuss all admissions with attending physicians. Attending physicians should be both cognizant of and have input into the care patients are to receive upon admission to the hospitalInhouse supervision should be required for all critical care services, including emergency rooms, intensive care units, and trauma services. Resident physicians should not be left unsupervised to care for critically ill patients. In settings in which the acuity is high, physicians who have completed residency should provide direct supervision for resident physicians. Supervising physicians should always be physically in the hospital for supervision of resident physicians who care for critically ill patientsThe ACGME should explicitly define “good” supervision by specialty and by year of training. Explicit requirements for intensity and level of training for supervision of specific clinical scenarios should be providedCenters for Medicare and Medicaid Services (CMS) should use graduate medical education funding to provide incentives to programs with proven, effective levels of supervision. Although this action would require federal legislation, reimbursement rules would help to ensure that hospitals pay attention to the importance of good supervision and require it from their training programs
Resident physician work hours
Although the IOM “Sleep, supervision and safety” report provides a comprehensive review and discussion of all aspects of graduate medical education training, the report’s focal point is its recommendations regarding the hours that resident physicians are currently required to work. A considerable body of scientific evidence, much of it cited by the Institute of Medicine report, describes deteriorating performance in fatigued humans, as well as specific studies on resident physician fatigue and preventable medical errors.
The question before this conference was what work redesign and cultural changes are needed to reform work hours as recommended by the Institute of Medicine’s evidence-based report? Extensive scientific data demonstrate that shifts exceeding 12–16 hours without sleep are unsafe. Several principles should be followed in efforts to reduce consecutive hours below this level and achieve safer work schedules. The recommendations are: Limit resident physician work hours to 12–16 hour maximum shiftsA minimum of 10 hours off duty should be scheduled between shiftsResident physician input into work redesign should be actively solicitedSchedules should be designed that adhere to principles of sleep and circadian science; this includes careful consideration of the effects of multiple consecutive night shifts, and provision of adequate time off after night work, as specified in the IOM reportResident physicians should not be scheduled up to the maximum permissible limits; emergencies frequently occur that require resident physicians to stay longer than their scheduled shifts, and this should be anticipated in scheduling resident physicians’ work shiftsHospitals should anticipate the need for iterative improvement as new schedules are initiated; be prepared to learn from the initial phase-in, and change the plan as neededAs resident physician work hours are redesigned, attending physicians should also be considered; a potential consequence of resident physician work hour reduction and increased supervisory requirements may be an increase in work for attending physicians; this should be carefully monitored, and adjustments to attending physician work schedules made as needed to prevent unsafe work hours or working conditions for this group“Home call” should be brought under the overall limits of working hours; work load and hours should be monitored in each residency program to ensure that resident physicians and fellows on home call are getting sufficient sleepMedicare funding for graduate medical education in each hospital should be linked with adherence to the Institute of Medicine limits on resident physician work hours
Moonlighting by resident physicians
The Institute of Medicine report recommended including external as well as internal moonlighting in working hour limits. The recommendation is: All moonlighting work hours should be included in the ACGME working hour limits and actively monitored. Hospitals should formalize a moonlighting policy and establish systems for actively monitoring resident physician moonlighting
Safety of resident physicians
The “Sleep, supervision and safety” report also addresses fatigue-related harm done to resident physicians themselves. The report focuses on two main sources of physical injury to resident physicians impaired by fatigue, ie, needle-stick exposure to blood-borne pathogens and motor vehicle crashes. Providing safe transportation home for resident physicians is a logistical and financial challenge for hospitals. Educating physicians at all levels on the dangers of fatigue is clearly required to change driving behavior so that safe hospital-funded transport home is used effectively. Fatigue-related injury prevention (including not driving while drowsy) should be taught in medical school and during residency, and reinforced with attending physicians; hospitals and residency programs must be informed that resident physicians’ ability to judge their own level of impairment is impaired when they are sleep deprived; hence, leaving decisions about the capacity to drive to impaired resident physicians is not recommendedHospitals should provide transportation to all resident physicians who report feeling too tired to drive safely; in addition, although consecutive work should not exceed 16 hours, hospitals should provide transportation for all resident physicians who, because of unforeseen reasons or emergencies, work for longer than consecutive 24 hours; transportation under these circumstances should be automatically provided to house staff, and should not rely on self-identification or request
Training in effective handovers and quality improvement
Handover practice for resident physicians, attendings, and other health care providers has long been identified as a weak link in patient safety throughout health care settings. Policies to improve handovers of care must be tailored to fit the appropriate clinical scenario, recognizing that information overload can also be a problem. At the heart of improving handovers is the organizational effort to improve quality, an effort in which resident physicians have typically been insufficiently engaged. The recommendations are: Hospitals should train attending and resident physicians in effective handovers of careHospitals should create uniform processes for handovers that are tailored to meet each clinical setting; all handovers should be done verbally and face-to-face, but should also utilize written toolsWhen possible, hospitals should integrate hand-over tools into their electronic medical records (EMR) systems; these systems should be standardized to the extent possible across residency programs in a hospital, but may be tailored to the needs of specific programs and services; federal government should help subsidize adoption of electronic medical records by hospitals to improve signoutWhen feasible, handovers should be a team effort including nurses, patients, and familiesHospitals should include residents in their quality improvement and patient safety efforts; the ACGME should specify in their core competency requirements that resident physicians work on quality improvement projects; likewise, the Joint Commission should require that resident physicians be included in quality improvement and patient safety programs at teaching hospitals; hospital administrators and residency program directors should create opportunities for resident physicians to become involved in ongoing quality improvement projects and root cause analysis teams; feedback on successful quality improvement interventions should be shared with resident physicians and broadly disseminatedQuality improvement/patient safety concepts should be integral to the medical school curriculum; medical school deans should elevate the topics of patient safety, quality improvement, and teamwork; these concepts should be integrated throughout the medical school curriculum and reinforced throughout residency; mastery of these concepts by medical students should be tested on the United States Medical Licensing Examination (USMLE) stepsFederal government should support involvement of resident physicians in quality improvement efforts; initiatives to improve quality by including resident physicians in quality improvement projects should be financially supported by the Department of Health and Human Services
Monitoring and oversight of the ACGME
While the ACGME is a key stakeholder in residency training, external voices are essential to ensure that public interests are heard in the development and monitoring of standards. Consequently, the Institute of Medicine report recommended external oversight and monitoring through the Joint Commission and Centers for Medicare and Medicaid Services (CMS). The recommendations are: Make comprehensive fatigue management a Joint Commission National Patient Safety Goal; fatigue is a safety concern not only for resident physicians, but also for nurses, attending physicians, and other health care workers; the Joint Commission should seek to ensure that all health care workers, not just resident physicians, are working as safely as possibleFederal government, including the Centers for Medicare and Medicaid Services and the Agency for Healthcare Research and Quality, should encourage development of comprehensive fatigue management programs which all health systems would eventually be required to implementMake ACGME compliance with working hours a “ condition of participation” for reimbursement of direct and indirect graduate medical education costs; financial incentives will greatly increase the adoption of and compliance with ACGME standards
Future financial support for implementation
The Institute of Medicine’s report estimates that $1.7 billion (in 2008 dollars) would be needed to implement its recommendations. Twenty-five percent of that amount ($376 million) will be required just to bring hospitals into compliance with the existing 2003 ACGME rules. Downstream savings to the health care system could potentially result from safer care, but these benefits typically do not accrue to hospitals and residency programs, who have been asked historically to bear the burden of residency reform costs. The recommendations are: The Institute of Medicine should convene a panel of stakeholders, including private and public funders of health care and graduate medical education, to lay down the concrete steps necessary to identify and allocate the resources needed to implement the recommendations contained in the IOM “Resident duty hours: Enhancing sleep, supervision and safety” report. Conference participants suggested several approaches to engage public and private support for this initiativeEfforts to find additional funding to implement the Institute of Medicine recommendations should focus more broadly on patient safety and health care delivery reform; policy efforts focused narrowly upon resident physician work hours are less likely to succeed than broad patient safety initiatives that include residency redesign as a key componentHospitals should view the Institute of Medicine recommendations as an opportunity to begin resident physician work redesign projects as the core of a business model that embraces safety and ultimately saves resourcesBoth the Secretary of Health and Human Services and the Director of the Centers for Medicare and Medicaid Services should take the Institute of Medicine recommendations into consideration when promulgating rules for innovation grantsThe National Health Care Workforce Commission should consider the Institute of Medicine recommendations when analyzing the nation’s physician workforce needs
Recommendations for future research
Conference participants concurred that convening the stakeholders and agreeing on a research agenda was key. Some observed that some sectors within the medical education community have been reluctant to act on the data. Several logical funders for future research were identified. But above all agencies, Centers for Medicare and Medicaid Services is the only stakeholder that funds graduate medical education upstream and will reap savings downstream if preventable medical errors are reduced as a result of reform of resident physician work hours.
doi:10.2147/NSS.S19649
PMCID: PMC3630963  PMID: 23616719
resident; hospital; working hours; safety
22.  Relation between indicators for quality of occupational rehabilitation of employees with low back pain 
OBJECTIVES: To assess if the implementation of guidelines for occupational rehabilitation of patients with low back pain by means of process variables--a set of objective criteria for technical performance and continuity of care--led to a better outcome in clinical and return to work variables. METHODS: The study group consisted of 59 patients with at least 10 days of sick leave because of low back pain. Univariate analyses as well as multiple logistic regression and Cox's regression analyses were performed to assess the relation between quality of care and outcome. RESULTS: Process indicators for technical competence, continuity of care, and total performance were all significantly related to satisfaction of employees. Continuity of care and total performance were significantly related to working status at 3 months, and time to return to work. None of the process indicators was related to pain or disability after 3 months follow up. Satisfaction was not related to any of the other outcome variables. This indicates that if guidelines for occupational rehabilitation are met, outcome is better. CONCLUSION: Quality of the process of care was related to outcome. Interventions of occupational physicians need improvement in the areas of continuity of care and communication with treating physicians. The effectiveness of an improved intervention should be studied in a subsequent randomised clinical trial.
 
PMCID: PMC1757763  PMID: 10472321
23.  Systematic reviews of bed rest and advice to stay active for acute low back pain. 
BACKGROUND: In the United Kingdom (UK), 9% of adults consult their doctor annually with back pain. The treatment recommendations are based on orthopaedic teaching, but the current management is causing increasing dissatisfaction. Many general practitioners (GPs) are confused about what constitutes effective advice. AIM: To review all randomized controlled trials of bed rest and of medical advice to stay active for acute back pain. METHOD: A systematic review based on a search of MEDLINE and EMBASE from 1966 to April 1996 with complete citation tracking for randomized controlled trials of bed rest or medical advice to stay active and continue ordinary daily activities. The inclusion criteria were: primary care setting, patients with low back pain of up to 3 months duration, and patient-centred outcomes (rate of recovery from the acute attack, relief of pain, restoration of function, satisfaction with treatment, days off work and return to work, development of chronic pain and disability, recurrent attacks, and further health care use). RESULTS: Ten trials of bed rest and eight trials of advice to stay active were identified. Consistent findings showed that bed rest is not an effective treatment for acute low back pain but may delay recovery. Advice to stay active and to continue ordinary activities results in a faster return to work, less chronic disability, and fewer recurrent problems. CONCLUSION: A simple but fundamental change from the traditional prescription of bed rest to positive advice about staying active could improve clinical outcomes and reduce the personal and social impact of back pain.
PMCID: PMC1410119  PMID: 9474831
24.  Endovascular Laser Therapy for Varicose Veins 
Executive Summary
Objective
The objective of the MAS evidence review was to conduct a systematic review of the available evidence on the safety, effectiveness, durability and cost–effectiveness of endovascular laser therapy (ELT) for the treatment of primary symptomatic varicose veins (VV).
Background
The Ontario Health Technology Advisory Committee (OHTAC) met on November 27, 2009 to review the safety, effectiveness, durability and cost-effectiveness of ELT for the treatment of primary VV based on an evidence-based review by the Medical Advisory Secretariat (MAS).
Clinical Condition
VV are tortuous, twisted, or elongated veins. This can be due to existing (inherited) valve dysfunction or decreased vein elasticity (primary venous reflux) or valve damage from prior thrombotic events (secondary venous reflux). The end result is pooling of blood in the veins, increased venous pressure and subsequent vein enlargement. As a result of high venous pressure, branch vessels balloon out leading to varicosities (varicose veins).
Symptoms typically affect the lower extremities and include (but are not limited to): aching, swelling, throbbing, night cramps, restless legs, leg fatigue, itching and burning. Left untreated, venous reflux tends to be progressive, often leading to chronic venous insufficiency (CVI).
A number of complications are associated with untreated venous reflux: including superficial thrombophlebitis as well as variceal rupture and haemorrhage. CVI often results in chronic skin changes referred to as stasis dermatitis. Stasis dermatitis is comprised of a spectrum of cutaneous abnormalities including edema, hyperpigmentation, eczema, lipodermatosclerosis and stasis ulceration. Ulceration represents the disease end point for severe CVI.
CVI is associated with a reduced quality of life particularly in relation to pain, physical function and mobility. In severe cases, VV with ulcers, QOL has been rated to be as bad or worse as other chronic diseases such as back pain and arthritis.
Lower limb VV is a common disease affecting adults and estimated to be the seventh most common reason for physician referral in the US. There is a strong familial predisposition to VV with the risk in offspring being 90% if both parents affected, 20% when neither is affected, and 45% (25% boys, 62% girls) if one parent is affected. Globally, the prevalence of VV ranges from 5% to 15% among men and 3% to 29% among women varying by the age, gender and ethnicity of the study population, survey methods and disease definition and measurement. The annual incidence of VV estimated from the Framingham Study was reported to be 2.6% among women and 1.9% among men and did not vary within the age range (40-89 years) studied.
Approximately 1% of the adult population has a stasis ulcer of venous origin at any one time with 4% at risk. The majority of leg ulcer patients are elderly with simple superficial vein reflux. Stasis ulcers are often lengthy medical problems and can last for several years and, despite effective compression therapy and multilayer bandaging are associated with high recurrence rates. Recent trials involving surgical treatment of superficial vein reflux have resulted in healing and significantly reduced recurrence rates.
Endovascular Laser Therapy for VV
ELT is an image-guided, minimally invasive treatment alternative to surgical stripping of superficial venous reflux. It does not require an operating room or general anesthesia and has been performed in outpatient settings by a variety of medical specialties including surgeons (vascular or general), interventional radiologists and phlebologists. Rather than surgically removing the vein, ELT works by destroying, cauterizing or ablating the refluxing vein segment using heat energy delivered via laser fibre.
Prior to ELT, colour-flow Doppler ultrasonography is used to confirm and map all areas of venous reflux to devise a safe and effective treatment plan. The ELT procedure involves the introduction of a guide wire into the target vein under ultrasound guidance followed by the insertion of an introducer sheath through which an optical fibre carrying the laser energy is advanced. A tumescent anesthetic solution is injected into the soft tissue surrounding the target vein along its entire length. This serves to anaesthetize the vein so that the patient feels no discomfort during the procedure. It also serves to insulate the heat from damaging adjacent structures, including nerves and skin. Once satisfactory positioning has been confirmed with ultrasound, the laser is activated. Both the laser fibre and the sheath are simultaneously, slowly and continuously pulled back along the length of the target vessel. At the end of the procedure, homeostasis is then achieved by applying pressure to the entry point.
Adequate and proper compression stockings and bandages are applied after the procedure to reduce the risk of venous thromboembolism, and to reduce postoperative bruising and tenderness. Patients are encouraged to walk immediately after the procedure and most patients return to work or usual activity within a few days. Follow-up protocols vary, with most patients returning 1-3 weeks later for an initial follow-up visit. At this point, the initial clinical result is assessed and occlusion of the treated vessels is confirmed with ultrasound. Patients often have a second follow-up visit 1-3 months following ELT at which time clinical evaluation and ultrasound are repeated. If required, sclerotherapy may be performed during the ELT procedure or at any follow-up visits.
Regulatory Status
Endovascular laser for the treatment of VV was approved by Health Canada as a class 3 device in 2002. The treatment has been an insured service in Saskatchewan since 2007 and is the only province to insure ELT. Although the treatment is not an insured service in Ontario, it has been provided by various medical specialties since 2002 in over 20 private clinics.
Methods
Literature Search
The MAS evidence-based review was performed as an update to the 2007 health technology review performed by the Australian Medical Services Committee (MSAC) to support public financing decisions. The literature search was performed on August 18, 2009 using standard bibliographic databases for studies published from January 1, 2007 to August 15, 2009. Search alerts were generated and reviewed for additional relevant literature up until October 1, 2009.
Inclusion Criteria
English language full-reports and human studies
Original reports with defined study methodology
Reports including standardized measurements on outcome events such as technical success, safety, effectiveness, durability, quality of life or patient satisfaction
Reports involving ELT for VV (great or small saphenous veins)
Randomized controlled trials (RCTs), systematic reviews and meta-analyses
Cohort and controlled clinical studies involving > 1 month ultrasound imaging follow-up
Exclusion Criteria
Non systematic reviews, letters, comments and editorials
Reports not involving outcome events such as safety, effectiveness, durability, or patient satisfaction following an intervention with ELT
Reports not involving interventions with ELT for VV
Pilot studies or studies with small samples ( < 50 subjects)
Summary of Findings
The MAS evidence search identified 14 systematic reviews, 29 cohort studies on safety and effectiveness, four cost studies and 12 randomized controlled trials involving ELT, six of these comparing endovascular laser with surgical ligation and saphenous vein stripping.
Since 2007, 22 cohort studies involving 10,883 patients undergoing ELT of the great saphenous vein (GSV) have been published. Imaging defined treatment effectiveness of mean vein closure rates were reported to be greater than 90% (range 93%- 99%) at short term follow-up. Longer than one year follow-up was reported in five studies with life table analysis performed in four but the follow up was still limited at three and four years. The overall pooled major adverse event rate, including DVT, PE, skin burns or nerve damage events extracted from these studies, was 0.63% (69/10,883).
The overall level of evidence of randomized trials comparing ELT with surgical ligation and vein stripping (n= 6) was graded as moderate to high. Recovery after treatment was significantly quicker after ELT (return to work median number of days, 4 vs. 17; p= .005). Major adverse events occurring after surgery were higher [(1.8% (n=4) vs. 0.4% (n = 1) 1 but not significantly. Treatment effectiveness as measured by imaging vein absence or closure, symptom relief or quality of life similar in the two treatment groups and both treatments resulted in statistically significantly improvements in these outcomes. Recurrence was low after both treatments at follow up but neovascularization (growth of new vessels, a key predictor of long term recurrence was significantly more common (18% vs. 1%; p = .001) after surgery. Although patient satisfaction was reported to be high (>80%) with both treatments, patient preferences evaluated through recruitment process, physician reports and consumer groups were strongly in favour of ELT. For patients minimal complications, quick recovery and dependability of outpatient scheduling were key considerations.
As clinical effectiveness of the two treatments was similar, a cost-analysis was performed to compare differences in resources and costs between the two procedures. A budget impact analysis for introducing ELT as an insured service was also performed. The average case cost (based on Ontario hospital costs and medical resources) for surgical vein stripping was estimated to be $1,799. Because of the uncertainties with resources associated with ELT, in addition to the device related costs, hospital costs were varied and assumed to be the same as or less than (40%) those for surgery resulting in an average ELT case cost of $2,025 or $1,602.
Based on the historical pattern of surgical vein stripping for varices a 5-year projection was made for annual volumes and costs. In Ontario in 2007/2008, 3481 surgical vein stripping procedures were performed, 28% for repeat procedures. Annual volumes of ELT currently being performed in the province in over 20 private clinics were estimated to be approximately 840. If ELT were publicly reimbursed, it was assumed that it would capture 35% of the vein stripping market in the first year and increase to 55% in subsequent years. Based on these assumptions if ELT were not publicly reimbursed, the province would be paying approximately $5.9 million and if ELT were reimbursed the province would pay $8.2 million if the hospital costs for ELT were the same as surgery and $7.1 million if the hospital costs were less (40%) than surgery.
The conclusions on the comparative outcomes between laser ablation and surgical ligation and saphenous vein stripping are summarized in the table below (ES Table 1).
Outcome comparisons of ELT vs. surgery for VV
The outcomes of the evidence-based review on these treatments based on three different perspectives are summarized below:
Patient Outcomes – ELT vs. Surgery
ELT has a quicker recovery attributable to the decreased pain, lower minor complications, use of local anesthesia with immediate ambulation.
ELT is as effective as surgery in the short term as assessed by imaging anatomic outcomes, symptomatic relief and HRQOL outcomes.
Recurrence is similar but neovascularization, a key predictor of long term recurrence, is significantly higher with surgery.
Patient satisfaction is equally high after both treatments but patient preference is much more strongly for ELT. Surgeons performing ELT are satisfied with treatment outcomes and regularly offer ELT as a treatment alternative to surgery.
Clinical or Technical Advantages – ELT Over Surgery
An endovascular approach can more easily and more precisely treat multilevel disease and difficult to treat areas
ELT is an effective and a less invasive treatment for the elderly with VV and those with venous leg ulcers.
System Outcomes – ELT Replacing Surgery
ELT may offer system advantages in that the treatment can be offered by several medical specialties in outpatient settings and because it does not require an operating theatre or general anesthesia.
The treatment may result in ↓ pre-surgical investigations, decanting of patients from OR, ↓ demand on anesthetists time, ↓ hospital stay, ↓decrease wait time for VV treatment and provide more reliable outpatient scheduling.
Depending on the reimbursement mechanism for the treatment, however, it may also result in closure of outpatient clinics with an increasingly centralization of procedures in selected hospitals with large capital budgets resulting in larger and longer waiting lists.
Procedure costs may be similar for the two treatments but the budget impact may be greater with insurance of ELT because of the transfer of the cases from the private market to the public payer system.
PMCID: PMC3377531  PMID: 23074409
25.  The course of the acute vertebral body fragility fracture: its effect on pain, disability and quality of life during 12 months 
European Spine Journal  2008;17(10):1380-1390.
The vertebral body fracture is the most frequent bone fragility fracture. In spite of this there is considerable uncertainty about the frequency, extent and severity of the acute pain and even more about the duration of pain, the magnitude of disability and how much daily life is disturbed in the post-fracture period. The aim of the present study was to follow the course of pain, disability, ADL and QoL in patients during the year after an acute low energy vertebral body fracture. The study design was a longitudinal cohort study with prospective data collection. All the patients over 40 years admitted to the emergency unit because of back pain with a radiologically acute vertebral body fracture were eligible. A total of 107 patients were followed for a year. The pain, disability (von Korff pain and disability scores), ADL (Hannover ADL score), and QoL (EQ-5D) were measured after 3 weeks, 3, 6 and 12 months. Two-thirds of the patients were women, and were similar in average age, as the men around 75 years. A total of 65.4% of the fractures were due to a level fall or a minor trauma, whereas 34.6% had no recollection of trauma or a specific event as the cause of the fracture. A total of 76.6% of the fractured patients were immediately mobilized and allowed to return home while the remaining were hospitalized. The average pain intensity score after 3 weeks was 70.9 (SD 19.3), the disability score 68.9 (SD 23.6), the ADL score 37.7 (SD 22.1) and EQ-5D score of 0.37 (SD 0.37). The largest improvements, 10–15%, occurred between the initial visit and the 3 months follow-up and were quite similar for all the measures. From 3 months, all the outcome measures leveled out or tended to deteriorate resulting in a mean pain intensity score of 60.5, disability score of 53.9, ADL score of 47.6, and EQ-5D score 0.52 after 12 months. After a whole year the fractured patients’ condition was similar to the preoperative condition of patients with a herniated lumbar disc, central lumbar spinal stenosis or in patients 100% work disabled due to back or neck problems. Instead of the generally believed good prognosis for the greater majority of those fractured, the acute vertebral body fracture was the beginning of a long-lasting severe deterioration of their health.
doi:10.1007/s00586-008-0753-3
PMCID: PMC2556463  PMID: 18751742
Vertebral body fracture; Osteoporosis; Pain; Quality of life; Disability; Compression fracture

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