Pros and Cons of Randomized Controlled Trials and Benchmarking Controlled Trials in Rehabilitation: An Academic Debate within the European Academy of Rehabilitation Medicine.

The European Academy of Rehabilitation Medicine (EARM) held a debate in Hannover, Germany, on 1st of September 2016 on the pros  and cons of randomized controlled trials (RCTs) and observational effectiveness studies (benchmarking controlled trials; BCTs). The  debate involved a chairperson, a person presenting the substance of the debate, an opponent, and a rapporteur. The academicians participated in the discussion. Eight propositions and proposed statements formed the substance of the debate. There was agreement that a study question should be the starting point of an effectiveness study, and not the study method, i.e. RCT or BCT. The term "benchmarking" was questioned: does it mean market-oriented medicine? It was clarified that benchmarking refers to the methodological features of this study design: there must always be a comparison between peers. It was agreed that BCTs might be better than RCTs for use in rehabilitation studies, in which one often needs multi-centred studies, such as in the assessment of the effectiveness of pathways when there is complexity of processes, health systems, organizational issues, structures and facilities; or where interactions between therapists, doctors and patients differ between centres; and when assessing the implementation of rehabilitation. In addition, BCTs may deal with ethical issues, e.g. the acceptability of interventions, more easily than RCTs. Recommendations regarding the different approaches (RCTs or BCTs) should be provided by the scientific rehabilitation societies. Concern over the validity of BCTs was considered justified, as the validity criteria of BCTs cover all those related to RCTs and include the risk of selection bias between treatment arms. Appropriate description of the essentials of the study object, including adequate description of how the interventions were actualized in comparison to the study plan, are essential features for a valid and generalizable study for both RCTs and BCTs. BCTs are necessary to widen the evidence-base of effectiveness in rehabilitation. It was suggested that the rehabilitation field should support the concept of BCTs. It was proposed that education regarding BCTs is indicated, and stakeholders need to be convinced that BCTs are a valid alternative to RCTs. EARM and other physical and rehabilitation medicine (PRM) bodies could advance the use of BCTs for clinical and health policy decision-making.

A classification-based approach to low back pain in primary care - protocol for a benchmarking controlled trial.

BACKGROUND: Guidelines recommend a biopsychosocial framework for low back pain (LBP) management and the avoidance of inappropriate imaging. In clinical practice, care strategies are often inconsistent with evidence and guidelines, even though LBP is the most common disabling health condition worldwide. Unhelpful beliefs, attitudes and inappropriate imaging are common. LBP is understood to be a complex biopsychosocial phenomenon with many known multidimensional risk factors (symptom- and lifestyle-related, psychological and social) for persistent or prolonged disability, which should be identified and addressed by treatment. The STarT Back Tool (SBT) was developed for early identification of individual risk factors of LBP to enable targeted care. Stratified care according SBT has been shown to improve the effectiveness of care in a primary care setting. A biopsychosocially-oriented patient education booklet, which includes imaging guidelines and information, is one possible way to increase patients' understanding of LBP and to reduce inappropriate imaging. Premeditated pathways, education of professionals, written material, and electronic patient registry support in health care organizations could help implement evidence-based care. METHODS: We will use a Benchmarking Controlled Trial (BCT) design in our study. We will prospectively collect data from three health care regions before and after the implementation of a classification-based approach to LBP in primary care. The primary outcome will be change in PROMIS (Patient-Reported Outcomes Measurement Information System) (short form 20a) over 12-month follow-up. DISCUSSION: The implementation of a classification-based biopsychosocial approach can potentially improve the care of LBP patients, reduce inappropriate imaging without increasing health-care costs, and decrease indirect costs by reducing work disability. Using the BCT we will be able to evaluate the effectiveness of the improvement strategy for the entire care pathway. TRIAL REGISTRATION: ISRCTN,ISRCTN13273552, retrospectively registered 13/05/2019.

Systematic review of hospital-wide complication registries.

BACKGROUND: An institutional registry covering all surgical specialties could be an implementation tool in quality benchmarking between hospitals and aid determination of their cost-effectiveness. The objective of this systematic literature review was to evaluate original articles on existing prospective surgical registries that can be used by single institutions across surgical specialties. METHOD: A systematic review of the literature using PRISMA guidelines was conducted for articles focusing on hospital-wide surgical registries. Single-specialty retrospective registries, non-defined outcome measures or system protocols, and studies not in English were excluded. RESULTS: Five articles were included for analysis. Evaluation of the articles revealed wide methodological heterogeneity in the classification and categorization of complications and data collection methods. CONCLUSION: Ideal surgical quality monitoring systems should be real-time, contain patient-related risk factors, and encompass all surgical specialties. At present, such institutional registries are rarely reported and no consensus exists on their standard definitions and methodology.

Validity and generalizability of findings of randomized controlled trials on arthroscopic partial meniscectomy of the knee.

The validity and generalizability of evidence from trials on arthroscopic partial meniscectomy (APM) for a ruptured meniscus of the knee has been debated in scientific journals. The aim of this paper was to assess the validity and generalizability of evidence for trials on effectiveness of APM by a novel Benchmarking method; to compare this assessment with established assessment methods; and to make an overall assessment of the current evidence on validity and generalizability of findings. Literature search was undertaken to find all randomized controlled trials. The benchmarking method, the Cochrane method for the assessment of validity of RCTs, and CONSORT method for the assessment of generalizability of findings were used. The data were extracted and checked for accuracy twice. Seven RCTs were found, of which 2 were double blinded. The benchmarking method indicated that only one trial, assessing real-world effectiveness, had recruited patients comprehensively from the catchment area and showed clinically important effectiveness for APM. All trials had deficiencies in reporting of baseline characteristics and adherence to interventions. In 5 trials, the crossover to surgery from conservative treatment arm was between 19 and 36 percent. The benchmarking method indicates that APM may be an effective treatment for meticulously selected patients, or when APM is targeted to those patients who do not respond to the conservative treatment. There is a need for more sham-controlled and real-world effectiveness trials reporting comprehensively patient characteristics and adherence to interventions, preferably in a representative sample of patients living in the recruitment area.

Effectiveness of three interventions for secondary prevention of low back pain in the occupational health setting - a randomised controlled trial with a natural course control.

BACKGROUND: We assessed the effectiveness of three interventions that were aimed to reduce non-acute low back pain (LBP) related symptoms in the occupational health setting. METHODS: Based on a survey (n = 2480; response rate 71%) on LBP, we selected a cohort of 193 employees who reported moderate LBP (Visual Analogue Scale VAS > 34 mm) and fulfilled at least one of the following criteria during the past 12 months: sciatica, recurrence of LBP ≥ 2 times, LBP ≥ 2 weeks, or previous sickness absence. A random sample was extracted from the cohort as a control group (Control, n = 50), representing the natural course of LBP. The remaining 143 employees were invited to participate in a randomised controlled trial (RCT) of three 1:1:1 allocated parallel intervention arms: multidisciplinary rehabilitation (Rehab, n = 43); progressive exercises (Physio, n = 43) and self-care advice (Advice, n = 40). Seventeen employees declined participation in the intervention. The primary outcome measures were physical impairment (PHI), LBP intensity (Visual Analogue Scale), health related quality of life (QoL), and accumulated sickness absence days. We imputed missing values with multiple imputation procedure. We assessed all comparisons between the intervention groups and the Control group by analysing questionnaire outcomes at 2 years with ANOVA and sickness absence at 4 years by using negative binomial model with a logarithmic link function. RESULTS: Mean differences between the Rehab and Control groups were - 3 [95% CI -5 to - 1] for PHI, - 13 [- 24 to - 1] for pain intensity, and 0.06 [0.00 to 0.12] for QoL. Mean differences between the Physio and Control groups were - 3 [95% CI -5 to - 1] for PHI, - 13 [- 29 to 2] for pain intensity, and 0.07 [0.01 to 0.13] for QoL. The main effects sizes were from 0.4 to 0.6. The interventions were not effective in reducing sickness absence. CONCLUSIONS: Rehab and Physio interventions improved health related quality of life, decreased low back pain and physical impairment in non-acute, moderate LBP, but we found no differences between the Advice and Control group results. No effectiveness on sickness absence was observed. TRIAL REGISTRATION: Number NCT00908102 Clinicaltrials.gov.

Shoulder Capsular Surgery in Finland Between 1999 and 2008: A Nationwide Register Analysis.

BACKGROUND AND AIMS: Shoulder capsular surgery is nowadays usually performed arthroscopically, and the proportion of arthroscopic method has rapidly increased during the last two decades. We assessed the incidence of shoulder capsular surgery procedures in Finland between 1999 and 2008. MATERIAL AND METHODS: We gathered the shoulder capsular surgery procedures for all kinds of shoulder instability in Finland between 1999 and 2008 from National Hospital Discharge Register and limited the patient material to include only certain diagnosis (International Classification of Diseases, 10th Edition) and Nordic Medico-Statistical Committee procedure code combinations. We analyzed the data in the whole country, between different age groups, and in university hospital districts. RESULTS: The total incidence of shoulder capsular surgery procedures in Finland increased from 17 to 33 per 100,000 person-years. The incidence of arthroscopic procedures increased from 11 to 30 per 100,000 person-years and the proportion of arthroscopic procedures increased from 63% to 92% between years 1999 and 2007. The incidence of shoulder capsular surgery procedures increased on average around 90% in almost all age groups and particularly in the older age groups. We observed no significant geographical variation between university hospital districts. CONCLUSION: The incidence of shoulder capsular surgery procedures increased on average round 90% in almost all age groups. It seems to be difficult to support the rapidly increased rates of shoulder capsular surgery procedures or the arthroscopic method based on scientific evidence. While also older patients are treated with shoulder capsular surgery, well-defined indications for surgical intervention are needed so that the operations are conducted for the symptomatic patients benefitting most regardless of patients' age.

Cost-effectiveness of providing patients with information on managing mild low-back symptoms in an occupational health setting.

BACKGROUND: Evidence shows that low back specific patient information is effective in sub-acute low back pain (LBP), but effectiveness and cost-effectiveness (CE) of information in early phase symptoms is not clear. We assessed effectiveness and CE of patient information in mild LBP in the occupational health (OH) setting in a quasi-experimental study. METHODS: A cohort of employees (N = 312, aged <57) with non-specific, mild LBP (Visual Analogue Scale between 10-34 mm) was selected from the respondents of an employee survey (N = 2480; response rate 71 %). A random sample, representing the natural course of LBP (NC, N = 83; no intervention), was extracted as a control group. Remaining employees were invited (181 included, 47 declined, one excluded) into a randomised controlled study with two 1:1 allocated parallel intervention arms ("Booklet", N = 92; "Combined", N = 89). All participants received the "Back Book" patient information booklet and the Combined also an individual verbal review of the booklet. Physical impairment (PHI), LBP, health care (HC) utilisation, and all-cause sickness absence (SA) were assessed at two years. CE of the interventions on SA days was analysed by using direct HC costs in one year, two years from baseline. Multiple imputation was used for missing values. RESULTS: Compared to NC, the Booklet reduced HC costs by 196€ and SA by 3.5 days per year. In 81 % of the bootstrapped cases the Booklet was both cost saving and effective on SA. Compared to NC, in the Combined arm, the figures were 107€, 0.4 days, and 54 %, respectively. PHI decreased in both interventions. CONCLUSIONS: Booklet information alone was cost-effective in comparison to natural course of mild LBP. Combined information reduced HC costs. Both interventions reduced physical impairment. Mere booklet information is beneficial for employees who report mild LBP in the OH setting, and is also cost saving for the health care system. TRIAL REGISTRATION: ClinicalTrials.gov NCT00908102.

Comparing ischaemic stroke in six European countries. The EuroHOPE register study.

BACKGROUND AND PURPOSE: The incidence of hospitalizations, treatment and case fatality of ischaemic stroke were assessed utilizing a comprehensive multinational database to attempt to compare the healthcare systems in six European countries, aiming also to identify the limitations and make suggestions for future improvements in the between-country comparisons. METHODS: National registers of hospital discharges for ischaemic stroke identified by International Classification of Diseases codes 433-434 (ICD-9) and code I63 (ICD-10), medication purchases and mortality were linked at the patient level in each of the participating countries and regions: Finland, Hungary, Italy, the Netherlands, Scotland and Sweden. Patients with an index admission in 2007 were followed for 1 year. RESULTS: In all, 64,170 patients with a disease code for ischaemic stroke were identified. The number of patients registered per 100,000 European standard population ranged from 77 in Scotland to 407 in Hungary. Large differences were observed in medication use. The age- and sex-adjusted all-cause case fatality amongst hospitalized patients at 1 year from stroke was highest in Hungary at 31.0% (95% confidence interval 30.5-31.5). Regional differences in age- and sex-adjusted 1-year case fatality within countries were largest in Hungary (range 23.6%-37.6%) and smallest in the Netherlands (20.5%-27.3%). CONCLUSIONS: It is feasible to link population-wide register data amongst European countries to describe incidence of hospitalizations, treatment patterns and case fatality of ischaemic stroke on a national level. However, the coverage and validity of administrative register data for ischaemic stroke should be developed further, and population-based and clinical stroke registers should be created to allow better control of case mix.

Compression therapy versus surgery in the treatment of patients with varicose veins: A RCT.

OBJECTIVE: Superficial venous reflux and varicose veins are common. The aim of this randomized controlled trial was to assess effectiveness of compression therapy compared with surgery for superficial venous reflux. METHODS: 153 patients with CEAP class C2-C3 and superficial venous reflux were randomized to receive either conservative treatment (compression stockings) (n = 77) or surgery (n = 76). Clinical examination including duplex ultrasound (DUS) was performed at entry and 1 and 2 years after randomization (compression group) or surgery (surgery group). Venous Clinical Severity Score without compression stockings (VCSS-S), Venous Segmental Disease Score (VSDS), Venous Disability Score (VDS), and health-related quality of life (HRQoL) were assessed at entry and at the follow-ups. Data were analysed on an intention-to-treat basis and according to the actual treatment performed. RESULTS: At 2 years, 70/76 patients in the surgery group and 11/77 patients in the compression group had been operated on. VCSS-S decreased from 4.6 to 3.5 in the compression group (p < .01) and from 4.8 to 0.6 in the surgery group (p < .001). VSDS decreased from 7.7 to 7.0 in the compression group and from 8.2 to 0.9 in the surgery group (p < .0001). HRQoL did not change in the compression group, but improved significantly in the surgery group. CONCLUSION: The surgical elimination of non-complicated superficial venous reflux is an effective treatment when compared with providing compression stockings only.

The effectiveness of two active interventions compared to self-care advice in employees with non-acute low back symptoms: a randomised, controlled trial with a 4-year follow-up in the occupational health setting.

OBJECTIVE: Evaluate the effectiveness of two active interventions, aimed at secondary prevention of low back pain (LBP), in occupational health. METHODS: We performed a survey of LBP (n=2480; response rate 71%) and randomized 143 employees (66% males, 45 years) with LBP over 34 mm on VAS into Rehabilitation (n=43), Exercise (n=43) or self-care (n=40) groups. Primary outcomes were LBP, physical impairment (PI) and health-related quality of life (HRQoL) for two years and sickness absence (SA) days during four years (LBP specific, total). RESULTS: Compared to self-care, exercise reduced LBP at 12 months (mean difference (MD) -12 mm; 95% CI -21 to -2) and improved HRQoL at 12 and 24 months (0.03; 0.00 to 0.05), but did not reduce PI. The MDs of SA days in four years were -17 (-70 to 35, total) and -15 (-47 to 13, LBP specific). Exercise reduced the probability of LBP specific SA during the third and fourth year. Compared to self-care, Rehabilitation reduced LBP at 3 months (-10 mm; -19 to -1) and 6 months (-10 mm; -20 to - 1), but was not effective in HRQoL or PI. The MDs of SA days in four years were -41 (-93 to 8; total) and 5 (-30 to 47; LBP specific). Rehabilitation reduced the probability of total SA during first and second year and amount of total SA days in the fourth year. CONCLUSIONS: Among employees with relatively mild LBP, both interventions reduced pain, but the effects on SA and PI were minor. Exercise improved HRQoL. The effect sizes were rather small. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT00908102.

Cost-utility of bariatric surgery for morbid obesity in Finland.

BACKGROUND: The aim of this study was to evaluate the cost-utility of bariatric surgery (gastric bypass, sleeve gastrectomy and gastric banding) compared with ordinary treatment in the Finnish healthcare system. METHODS: Analysis was done from a healthcare provider's perspective using a combination of a decision tree and a Markov model, with a time horizon of 10 years. Health-related quality of life was estimated from a representative population survey, and other parameter values were based on registers, systematic reviews, controlled studies and expert opinion. RESULTS: In the base-case analysis, bariatric surgery was both more effective and less costly than the ordinary treatment. The mean costs were €33,870 and €50,495, and the mean number of quality-adjusted life-years 7·63 and 7·05, for bariatric surgery and ordinary treatment respectively. Uncertainty around the parameter values was tested comprehensively in sensitivity analyses, and the results were robust. CONCLUSION: Surgery for morbid obesity increases health-related quality of life, and reduces the need for further treatments and total healthcare costs. According to this analysis, non-operative care would be more costly for the Finnish healthcare system on average after 5 years following surgery.

Does arthroscopic acromioplasty provide any additional value in the treatment of shoulder impingement syndrome?: a two-year randomised controlled trial.

We report a randomised controlled trial to examine the effectiveness and cost-effectiveness of arthroscopic acromioplasty in the treatment of stage II shoulder impingement syndrome. A total of 140 patients were randomly divided into two treatment groups: supervised exercise programme (n = 70, exercise group) and arthroscopic acromioplasty followed by a similar exercise programme (n = 70, combined treatment group). The main outcome measure was self-reported pain on a visual analogue scale of 0 to 10 at 24 months, measured on the 134 patients (66 in the exercise group and 68 in the combined treatment group) for whom endpoint data were available. An intention-to-treat analysis disclosed an improvement in both groups but without statistically significant difference in outcome between the groups (p = 0.65). The combined treatment was considerably more costly. Arthroscopic acromioplasty provides no clinically important effects over a structured and supervised exercise programme alone in terms of subjective outcome or cost-effectiveness when measured at 24 months. Structured exercise treatment should be the basis for treatment of shoulder impingement syndrome, with operative treatment offered judiciously until its true merit is proven.

Negative pressure wound therapy: a systematic review on effectiveness and safety.

OBJECTIVES: We reviewed the use of negative pressure wound treatment (NPWT) for problematic wounds. METHODS: A systematic literature review was undertaken to assess the effectiveness and safety of NPWT. Randomized controlled trials (RCTs) assessing NPWT were included. RESULTS: A total of 14 RCTs were included. Trials included patients with pressure wounds (2), post-traumatic wounds (3), diabetic foot ulcers (4) and miscellaneous chronic ulcers (5). In all trials NPWT was at least as effective and in some cases more effective than the control treatment. Most evidence supports the effectiveness of NPWT on chronic leg ulcers and posttraumatic ulcers. NPWT appears to be a safe treatment, and serious adverse events have been rarely reported. Only two trials were classified as high quality studies, whereas the remaining were classified as having poor internal validity. CONCLUSIONS: Reliable evidence on the effectiveness of NPWT is scarce. Tentative evidence indicates that the effectiveness of NPWT is at least as good as or better than current local treatment for wounds. The need for large high-quality randomised studies is apparent.

A randomised controlled trial on whether a participatory ergonomics intervention could prevent musculoskeletal disorders.

OBJECTIVES: To examine the efficacy of a participatory ergonomics intervention in preventing musculoskeletal disorders among kitchen workers. Participatory ergonomics is commonly recommended to reduce musculoskeletal disorders, but evidence for its effectiveness is sparse. METHODS: A cluster randomised controlled trial among the 504 workers of 119 kitchens in Finland was conducted during 2002-2005. Kitchens were randomised to an intervention (n = 59) and control (n = 60) group. The duration of the intervention that guided the workers to identify strenuous work tasks and to seek solutions for decreasing physical and mental workload, was 11 to 14 months. In total, 402 ergonomic changes were implemented. The main outcome measures were the occurrence of and trouble caused by musculoskeletal pain in seven anatomical sites, local fatigue after work, and sick leave due to musculoskeletal disorders. Individual level data were collected by a questionnaire at baseline and every 3 months during the intervention and 1-year follow-up period. All response rates exceeded 92%. RESULTS: No systematic differences in any outcome variable were found between the intervention and control groups during the intervention or during the 1-year follow-up. CONCLUSIONS: The intervention did not reduce perceived physical work load and no evidence was found for the efficacy of the intervention in preventing musculoskeletal disorders among kitchen workers. It may be that a more comprehensive redesign of work organisation and processes is needed, taking more account of workers' physical and mental resources.

An occupational health intervention programme for workers at high risk for sickness absence. Cost effectiveness analysis based on a randomised controlled trial.

OBJECTIVES: To determine whether, from a healthcare perspective, a specific occupational health intervention is cost effective in reducing sickness absence when compared with usual care in occupational health in workers with high risk of sickness absence. METHODS: Economic evaluation alongside a randomised controlled trial. 418 workers with high risk of sickness absence from one corporation were randomised to intervention (n = 209) or to usual care (n = 209). The subjects in the intervention group were invited to occupational health service for a consultation. The intervention included, if appropriate, a referral to specialist treatment. Register data of sickness absence were available for 384 subjects and questionnaire data on healthcare costs from 272 subjects. Missing direct total cost data were imputed using a two-part regression model. Primary outcome measures were sickness absence days and direct healthcare costs up to 12 months after randomisation. Cost effectiveness (CE) was expressed as an incremental CE ratio, CE plane and CE acceptability curve with both available direct total cost data and missing total cost data imputed. RESULTS: After one year, the mean of sickness absence was 30 days in the usual care group (n = 192) and 11 days less (95% CI 1 to 20 days) in the intervention group (n = 192). Among the employees with available cost data, the mean days of sickness absence were 22 and 24, and the mean total cost euro974 and euro1049 in the intervention group (n = 134) and in the usual care group (n = 138), respectively. The intervention turned out to be dominant-both cost saving and more effective than usual occupational health care. The saving was euro43 per sickness absence day avoided with available direct total cost data, and euro17 with missing total cost data imputed. CONCLUSIONS: One year follow-up data show that occupational health intervention for workers with high risk of sickness absence is a cost effective use of healthcare resources.

The effectiveness of two occupational health intervention programmes in reducing sickness absence among employees at risk. Two randomised controlled trials.

OBJECTIVES: To evaluate the effectiveness of two occupational health intervention programmes, both compared with usual care. METHODS: Based on a health survey, 1341 employees (88% males) in construction, service and maintenance work were classified into three groups: "low risk" (n = 386), "intermediate risk" (n = 537) and "high risk" (n = 418) of sickness absence. Two separate randomised trials were performed in the groups "high risk" and "intermediate risk", respectively. Those high risk subjects that were allocated to the intervention group (n = 209) were invited to occupational health service for a consultation. The intervention included, if appropriate, a referral to specialist treatment. Among the intermediate risk employees those in the intervention group (n = 268) were invited to call a phone advice centre. In both trials the control group received usual occupational health care. The primary outcome was sickness absence during a 12-month follow-up (register data). RESULTS: The high risk group, representing 31% of the cohort, accounted for 62% of sickness absence days. In the trial for the high risk group the mean sickness absence was 30 days in the usual care group and 19 days in the intervention group; the mean difference was 11 days (95% CI 1 to 20 days). In the trial for the intermediate risk group the mean sickness absence was 7 days in both arms (95% CI of the mean difference -2.3 to 2.4 days). CONCLUSIONS: The identification of high risk of work disability was successful. The occupational health intervention was effective in controlling work loss to a degree that is likely to be economically advantageous within the high risk group. The phone advice intervention for the intermediate risk group was not effective in controlling work loss primarily due to poor adherence.

WITHDRAWN: Multidisciplinary bio-psycho-social rehabilitation for chronic low-back pain.

BACKGROUND: Chronic low back pain is, in many countries, the main cause of long term disability in middle age. Patients with chronic low back pain are often referred for multidisciplinary treatment. Previous published systematic reviews on this topic included no randomised controlled trials and pooled together controlled and non-controlled studies. OBJECTIVES: To assess the effect of multidisciplinary bio-psycho-social rehabilitation on pain, function, employment, quality of life and global assessment outcomes in subjects with chronic disabling low back pain. SEARCH STRATEGY: We searched MEDLINE, EMBASE, PsychLIT, CINAHL, Health STAR, and The Cochrane Library from the beginning of the database to June 1998 using the comprehensive search strategy recommended by the Back Review Group of the Cochrane Collaboration. INTERVENTION specific key words for this review were: patient care team, patient care management, multidisciplinary, interdisciplinary, multiprofessional, multimodal, pain clinic and functional restoration. We also reviewed reference lists and consulted the editors of the Back Review Group of the Cochrane Collaboration. DESIGN: randomised controlled trials comparing multidisciplinary bio-psycho-social rehabilitation with a non-multidisciplinary control intervention. POPULATION: Adults with disabling low back pain of more than three months in duration. INTERVENTION: Patients had to be assessed and treated by qualified professionals according to a plan that addresses physical and at least one of psychological, or social/occupational dimensions. OUTCOMES: Only trials which reported treatment effect in at least one of pain, function, employment status, quality of life or global improvement.Exclusion: Pure educational interventions (back schools) and pure physical interventions were excluded. DATA COLLECTION AND ANALYSIS: Selection, data extraction and quality grading of studies was done by two independent authors using pre-tested data forms. Study quality was assessed according to the scheme recommended by the Back Review Group of the Cochrane Collaboration. Trials with internal validity scores of five or more in a ten point scale were considered high quality. Discrepancies between authors were resolved by consensus or by a third author. Given the marked heterogeneity in study settings, interventions and control groups we decided not to pool trial results in a meta-analysis. Instead, we summarized findings by strength of evidence and nature of intervention and control treatments. The evidence was judged to be strong when multiple high quality trials produced generally consistent findings. It was judged to be moderate when multiple low quality or one high quality and one or more low quality trials produced generally consistent findings. Evidence was considered to be limited when only one randomised trial existed or if findings of existing trials were inconsistent. MAIN RESULTS: Ten trials (12 randomised comparisons) were included. They randomised a total of 1964 patients with chronic low back pain. There was strong evidence that intensive multidisciplinary bio-psycho-social rehabilitation with a functional restoration approach improved function when compared with inpatient or outpatient non-multidisciplinary treatments. There was moderate evidence that intensive multidisciplinary bio-psycho-social rehabilitation with a functional restoration approach improved pain when compared with outpatient non-multidisciplinary rehabilitation or usual care. There was contradictory evidence regarding vocational outcomes of intensive multidisciplinary bio-psycho-social intervention. Some trials reported improvements in work readiness, but others showed no significant reduction in sickness leaves. Less intensive outpatient psycho-physical treatments did not improve pain, function or vocational outcomes when compared with non-multidisciplinary outpatient therapy or usual care. Few trials reported effects on quality of life or global assessments. AUTHORS' CONCLUSIONS: The reviewed trials provide evidence that intensive multidisciplinary bio-psycho-social rehabilitation with a functional restoration approach improves pain and function. Less intensive interventions did not show improvements in clinically relevant outcomes.

Exercise therapy for treatment of non-specific low back pain.

BACKGROUND: Exercise therapy is widely used as an intervention in low-back pain. OBJECTIVES: To evaluate the effectiveness of exercise therapy in adult non-specific acute, subacute and chronic low-back pain versus no treatment and other conservative treatments. SEARCH STRATEGY: The Cochrane Central Register of Controlled Trials (Issue 3, 2004), MEDLINE, EMBASE, PsychInfo, CINAHL databases to October 2004; citation searches and bibliographic reviews of previous systematic reviews. SELECTION CRITERIA: Randomized controlled trials evaluating exercise therapy for adult non-specific low-back pain and measuring pain, function, return-to-work/absenteeism, and/or global improvement outcomes. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected studies and extracted data on study characteristics, quality, and outcomes at short, intermediate, and long-term follow-up. MAIN RESULTS: Sixty-one randomized controlled trials (6390 participants) met inclusion criteria: acute (11), subacute (6) and chronic (43) low-back pain (1 unclear). Evidence was found of effectiveness in chronic populations relative to comparisons at all follow-up periods; pooled mean improvement was 7.3 points (95% CI, 3.7 to 10.9) for pain (out of 100), 2.5 points (1.0 to 3.9) for function (out of 100) at earliest follow-up. In studies investigating patients (i.e. presenting to healthcare providers) mean improvement was 13.3 points (5.5 to 21.1) for pain, 6.9 (2.2 to 11.7) for function, representing significantly greater improvement over studies where participants included those recruited from a general population (e.g. with advertisements). There is some evidence of effectiveness of graded-activity exercise program in subacute low-back pain in occupational settings, though the evidence for other types of exercise therapy in other populations is inconsistent. There was evidence of equal effectiveness relative to comparisons in acute populations [pain: 0.03 points (95% CI, -1.3 to 1.4)]. LIMITATIONS: This review largely reflects limitations of the literature, including low quality studies with heterogeneous outcome measures, inconsistent and poor reporting, and possibility of publication bias. AUTHORS' CONCLUSIONS: Exercise therapy appears to be slightly effective at decreasing pain and improving function in adults with chronic low-back pain, particularly in healthcare populations. In subacute low-back pain there is some evidence that a graded activity program improves absenteeism outcomes, though evidence for other types of exercise is unclear. In acute low-back pain, exercise therapy is as effective as either no treatment or other conservative treatments.

Trend in methodological quality of randomised clinical trials in low back pain.

During the past decades, the number of published randomised clinical trials evaluating the efficacy of conservative treatments for low back pain has substantially increased. At the same time several initiatives were undertaken in order to improve the methodological quality of published randomised clinical trials, also in the field of low back pain. We investigated how the methodological quality of randomised clinical trials in the field of low back pain developed over time since the first published trial in 1961. Methodological scores of 269 RCTs included in 15 Cochrane reviews of conservative treatment for low back pain were compared. Overall many trials showed methodological shortcomings. The median overall quality scores ranged from 36 to 82% depending on the type of intervention. There were no improvements in median overall methodological quality over time from 1960 to 2004. Improvements were apparent for a few validity criteria only.

Surgical versus conservative interventions for anterior cruciate ligament ruptures in adults.

BACKGROUND: Anterior cruciate ligament rupture is a common knee injury. Surgical treatment, usually involving reconstruction of the ligament, is widely used especially in active individuals. OBJECTIVES: Evaluation of the effect of surgical treatment compared with conservative treatment of anterior cruciate ligament (ACL) rupture. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group Specialised Register (January 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2005), MEDLINE (1966 to January Week 3 2005), EMBASE (1988 to 2005 Week 05), MEDIC (1978 to January 1999), Current Contents (9.2.1998 to 1.2.1999), BIOSIS (1970 to December 1998), reference lists of articles and consulted trialists and experts. SELECTION CRITERIA: All randomised and quasi-randomised trials that compared surgical with conservative treatment of ACL rupture in adults. DATA COLLECTION AND ANALYSIS: Two authors independently performed study selection, data extraction and quality assessment. MAIN RESULTS: Two poor quality randomised trials conducted in the early 1980s were included in the review. The two trials differed considerably and no data pooling was done for the few shared outcome measures. One quasi-randomised trial of 167 people with a complete ACL rupture treated with repair or augmented repair versus conservative treatment found no difference in the return to sports activities between people treated surgically and those treated conservatively. Measures of knee stability and functional (Lysholm) knee scores were higher in surgically-treated participants. By the end of the follow-up period (average 55 months), three people treated with repair only and 16 treated conservatively had had ACL reconstruction. The other trial included 157 people with ACL injury. This found that conservatively-treated participants recovered from their injury more rapidly but, at the last follow up (minimum 13 months), the functional outcome was similar in both treatment groups. A large proportion of participants experienced some temporary discomfort after surgery and there were some more serious postoperative complications. There was less knee instability in surgically-treated participants and a tendency to fewer subsequent operations in the longer term. AUTHORS' CONCLUSIONS: There is insufficient evidence from randomised trials to determine whether surgery or conservative management was best for ACL injury in the 1980s, and no evidence to inform current practice. Good quality randomised trials are required to remedy this situation.