Interventions developed to improve disability outcomes for low back pain (LBP) often show only small effects. Mediation analysis was used to investigate what led to the effectiveness of the ...STarT Back trial, a large primary care-based trial that treated patients consulting with LBP according to their risk of a poor outcome. The high-risk subgroup, randomized to receive either psychologically-informed physiotherapy (n = 93) or current best care (n = 45), was investigated to explore pain-related distress and pain intensity as potential mediators of the relationship between treatment allocation and change in disability. Structural equation modeling was used to generate latent variables of pain-related distress and pain intensity from measures used to identify patients at high risk (fear-avoidance beliefs, depression, anxiety, and catastrophizing thoughts). Outcome was measured using the Roland–Morris Disability Questionnaire. Change in pain-related distress and pain intensity were found to have a significant mediating effect of .25 (standardized estimate, bootstrapped 95% confidence interval, .09–.39) on the relationship between treatment group allocation and change in disability outcome. This study adds to the evidence base of treatment mediation studies in pain research and the role of distress in influencing disability outcome in those with complex LBP.
Mediation analysis using structural equation modeling found that change in pain-related distress and pain intensity mediated treatment effect in the STarT Back trial. This type of analysis can be used to gain further insight into how interventions work, and lead to the design of more effective interventions in future.
•Identifying how treatments work is important in making them more effective in the future.•Changes in psychological distress and pain intensity are mediators of treatment effect.•This study adds to the evidence base for the role of mediators in pain research.
Background. Little is known about the prognosis of depression in older patients in general practice or the community. Objectives. To summarize available evidence on the course and prognostic factors ...of depression in older persons. Methods. We conducted a systematic, computerized search of Medline and PsycINFO. Manual search of references of included studies were done. Studies potentially eligible for inclusion were discussed by two reviewers. Methodological quality was independently assessed by two reviewers. Data regarding selection criteria, duration of follow-up, outcome of depression and prognostic factors were extracted. Results. We identified 40 studies reporting on four cohorts in general practice and 17 in the community. Of all, 67% were of high quality. Follow-up was up to 1 year in general practice and up to 10 years in the community. Information on treatment was hardly provided. About one in three patients developed a chronic course. Five cohorts used more than two measurements during follow-up, illustrating a fluctuating course of depression. Using a best evidence synthesis we summarized the value of prognostic indicators. General practice studies did not provide strong evidence for any factor. Community studies provided strong evidence for an association of baseline depression level, older age, external locus of control, somatic co-morbidity and functional limitations with persistent depression. Conclusion. Within the older population, age seems to be a negative prognostic factor, while older people are more likely to be exposed to most of the other prognostic factors identified.
We present a systematic review of prospective cohort studies. Our aim was to assess prognostic factors associated with functional recovery of patients with whiplash injuries. The failure of some ...patients to recover following whiplash injury has been linked to a number of prognostic factors. However, there is some inconsistency in the literature and there have been no systematic attempts to analyze the level of evidence for prognostic factors in whiplash recovery. Studies were selected for inclusion following a comprehensive search of MEDLINE, EMBASE, CINAHL, the database of the Dutch Institute of Allied Health Professions up until April 2002 and hand searches of the reference lists of retrieved articles. Studies were selected if the objective was to assess prognostic factors associated with recovery; the design was a prospective cohort study; the study population included at least an identifiable subgroup of patients suffering from a whiplash injury; and the paper was a full report published in English, German, French or Dutch. The methodological quality was independently assessed by two reviewers. A study was considered to be of 'high quality' if it satisfied at least 50% of the maximum available quality score. Two independent reviewers extracted data and the association between prognostic factors and functional recovery was calculated in terms of risk estimates. Fifty papers reporting on twenty-nine cohorts were included in the review. Twelve cohorts were considered to be of 'high quality'. Because of the heterogeneity of patient selection, type of prognostic factors and outcome measures, no statistical pooling was able to be performed. Strong evidence was found for high initial pain intensity being an adverse prognostic factor. There was strong evidence that for older age, female gender, high acute psychological response, angular deformity of the neck, rear-end collision, and compensation not being associated with an adverse prognosis. Several physical (e.g. restricted range of motion, high number of complaints), psychosocial (previous psychological problems), neuropsychosocial factors (nervousness), crash related (e.g. accident on highway) and treatment related factors (need to resume physiotherapy) showed limited prognostic value for functional recovery. High initial pain intensity is an important predictor for delayed functional recovery for patients with whiplash injury. Often mentioned factors like age, gender and compensation do not seem to be of prognostic value. Scientific information about prognostic factors can guide physicians or other care providers to direct treatment and to probably prevent chronicity.
De Quervain's tenosynovitis is a disorder characterised by pain on the radial (thumb) side of the wrist and functional disability of the hand. It can be treated by corticosteroid injection, splinting ...and surgery.
To summarise evidence on the efficacy and safety of corticosteroid injections for de Quervain's tenosynovitis.
We searched the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2009, Issue 2), MEDLINE (1966 to April 2009), EMBASE (1956 to April 2009), CINAHL (1982 to April 2009), AMED (1985 to April 2009), DARE, Dissertation Abstracts and PEDro (physiotherapy evidence database).
Randomised and controlled clinical trials evaluating the efficacy and safety of corticosteroid injections for de Quervain's tenosynovitis.
After screening abstracts of studies identified by the search we obtained full text articles of studies which fulfilled the selection criteria. We extracted data using a predefined electronic form. We assessed the methodological quality of included trials by using the checklist developed by Jadad and the Delphi list. We extracted data on the primary outcome measures: treatment success; severity of pain or tenderness at the radial styloid; functional impairment of the wrist or hand; and outcome of Finkelstein's test, and the secondary outcome measures: proportion of patients with side effects; type of side effects and patient satisfaction with injection treatment.
We found one controlled clinical trial of 18 participants (all pregnant or lactating women) that compared one steroid injection with methylprednisolone and bupivacaine to splinting with a thumb spica. All patients in the steroid injection group (9/9) achieved complete relief of pain whereas none of the patients in the thumb spica group (0/9) had complete relief of pain, one to six days after intervention (number needed to treat to benefit (NNTB) = 1, 95% confidence interval (CI) 0.8 to 1.2). No side effects or local complications of steroid injection were noted.
The efficacy of corticosteroid injections for de Quervain's tenosynovitis has been studied in only one small controlled clinical trial, which found steroid injections to be superior to thumb spica splinting. However, the applicability of our findings to daily clinical practice is limited, as they are based on only one trial with a small number of included participants, the methodological quality was poor and only pregnant and lactating women participated in the study. No adverse effects were observed.
Abstract Background The clinical outcomes following rituximab (RTX) treatment in patients with SLE is highly variable. We aimed to identify predictive and prognostic factors associated with RTX ...therapy outcomes in patients with SLE. Methods Studies in adults and paediatric patients with SLE were included. We included randomized clinical trials (RCTs) for predictors of differential treatment effect and cohort studies for potential prognostic factors in patients treated with RTX (global clinical, cutaneous and renal either response or relapse and side effects). Methodological quality was assessed using Cochrane Collaboration Risk of Bias tool and the Quality In Prognosis Studies Tool (QUIPS) for RCTs and cohort studies, respectively. The quality of subgroup analyses testing predictors of differential treatment response was also evaluated. A best evidence synthesis was performed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Results Sixteen articles were included (3 from 2 RCTs and 13 from 6 cohort studies). The overall quality of evidence (QoE) was low to very low (GRADE framework). QoE for predictive factors based on RCTs analysing sociodemographic variables, was rated very low due lack interaction tests, limited power of subgroup analyses, study limitations and imprecisions. Disease-related factors including clinical phenotype and severity, baseline anti-ENA antibodies and anti-Ro antibodies, interleukin (IL) 2/21 single nucleotide polymorphism (SNP), as well as post-RTX complete B cell depletion and earlier B cell repopulation showed some evidence for prognostic value, but were rated low to very low QoE because of early phase of investigation (exploratory analysis), insufficient adjustment for confounding in most studies, high risk of bias, inconsistency and imprecisions. Conclusions To date studies addressing prognostic factors are hypothesis generating and cannot be used to make any specific recommendations for routine clinical practice. A number of potential predictors/prognostic factors were identified which require to be validated as being specific for response to RTX therapy and to enable more personalised use of this agent.
To investigate the course of lateral epicondylitis and identify prognostic indicators associated with short- and longterm outcome of pain intensity.
We prospectively followed patients (n = 349) from ...2 randomized controlled trials investigating conservative interventions for lateral epicondylitis in primary care. Uni- and multivariate linear regression analyses were used to investigate the association between potential prognostic indicators and pain intensity (0-100 point scale) measured at 1, 6, and 12 months after randomization. Potential prognostic factors were duration of elbow complaints, concomitant neck pain, concomitant shoulder pain, previous elbow complaints, baseline pain scores, age, gender, involvement of dominant side, social class, and work status. The variables "study" and "treatment" were included as covariates in all models.
Pain scores at 1 month followup were higher in patients with severe pain, a long duration of elbow complaints, and concomitant shoulder pain. At 12 month followup, the only different prognostic indicator for poor outcome was concomitant neck pain, in place of shoulder pain. Patients from higher social classes reported lower pain scores at 12 month followup than patients from lower social classes.
Lateral epicondylitis seems to be a self-limiting condition in most patients. Long duration of elbow complaints, concomitant neck pain, and severe pain at presentation are associated with poor outcome at 12 months. Our results will help care providers give patients accurate information regarding their prognosis and assist in medical decision-making.
Patients with lateral epicondylitis (tennis elbow) are frequently treated with corticosteroid injections, in order to relieve pain and diminish disability. The objective of this review was to ...evaluate the effectiveness of corticosteroid injections for lateral epicondylitis. Randomised controlled trials (RCTs) were identified by a highly sensitive search strategy in six databases in combination with reference tracking. Two independent reviewers selected and assessed the methodological quality of RCTs that included patients with lateral epicondylitis treated with corticosteroid injection(s), and reported at least one clinically relevant outcome measure. Standardised mean differences were computed for continuous data and relative risks (RR) for dichotomous data. A best-evidence synthesis was conducted, weighting the studies with respect to their internal validity, statistical significance, clinical relevance, and statistical power. Thirteen studies consisting of 15 comparisons were included in the review, evaluating the effects of corticosteroid injections compared to placebo injection (n=2), injection with local anaesthetic (n=5), another conservative treatment (n=5), or another corticosteroid injection (n=3). Almost all studies had poor internal validity scores. For short-term outcomes (<or=6 weeks), statistically significant and clinically relevant differences were found on pain, global improvement and grip strength for corticosteroid injection compared to placebo, local anaesthetic and conservative treatments. For intermediate (6 weeks-6 months) and long-term outcomes (>or=6 months), no statistically significant or clinically relevant results in favour of corticosteroid injections were found. Although the available evidence shows superior short-term effects of corticosteroid injections for lateral epicondylitis, it is not possible to draw firm conclusions on the effectiveness of injections, due to the lack of high quality studies. No beneficial effects were found for intermediate or long-term follow-up. More, better designed, conducted and reported RCTs with intermediate and long-term follow-up are needed.
Many studies have evaluated the accuracy of dipstick tests as rapid detectors of bacteriuria and urinary tract infections (UTI). The lack of an adequate explanation for the heterogeneity of the ...dipstick accuracy stimulates an ongoing debate. The objective of the present meta-analysis was to summarise the available evidence on the diagnostic accuracy of the urine dipstick test, taking into account various pre-defined potential sources of heterogeneity.
Literature from 1990 through 1999 was searched in Medline and Embase, and by reference tracking. Selected publications should be concerned with the diagnosis of bacteriuria or urinary tract infections, investigate the use of dipstick tests for nitrites and/or leukocyte esterase, and present empirical data. A checklist was used to assess methodological quality.
70 publications were included. Accuracy of nitrites was high in pregnant women (Diagnostic Odds Ratio = 165) and elderly people (DOR = 108). Positive predictive values were >/=80% in elderly and in family medicine. Accuracy of leukocyte-esterase was high in studies in urology patients (DOR = 276). Sensitivities were highest in family medicine (86%). Negative predictive values were high in both tests in all patient groups and settings, except for in family medicine. The combination of both test results showed an important increase in sensitivity. Accuracy was high in studies in urology patients (DOR = 52), in children (DOR = 46), and if clinical information was present (DOR = 28). Sensitivity was highest in studies carried out in family medicine (90%). Predictive values of combinations of positive test results were low in all other situations.
Overall, this review demonstrates that the urine dipstick test alone seems to be useful in all populations to exclude the presence of infection if the results of both nitrites and leukocyte-esterase are negative. Sensitivities of the combination of both tests vary between 68 and 88% in different patient groups, but positive test results have to be confirmed. Although the combination of positive test results is very sensitive in family practice, the usefulness of the dipstick test alone to rule in infection remains doubtful, even with high pre-test probabilities.
Shoulder pain is common in primary care, and has an unfavourable outcome in many patients. Information on the costs associated with health care use and loss of productivity in patients with shoulder ...pain is very scarce. The objective of this study was to determine shoulder pain related costs during the 6 months after first consultation in general practice
A prospective cohort study consisting of 587 patients with a new episode of shoulder pain was conducted with a follow-up period of 6 months. Data on costs were collected by means of a cost diary during 6 months.
84% of the patients completed all cost diaries. The mean consumption of direct health care and non-health related care was low. During 6 months after first consultation for shoulder pain, the mean total costs a patient generated were 689 euro. Almost 50% of this total concerned indirect costs, caused by sick leave from paid work. A small proportion (12%) of the population generated 74% of the total costs.
The total costs in the 6 months after first consultation for shoulder pain in primary care, mostly generated by a small part of the population, are not alarmingly high.
BACKGROUND Recent systematic reviews of adjuvant acupuncture for IVF have pooled heterogeneous trials, without examining variables that might explain the heterogeneity. The aims of our meta-analysis ...were to quantify the overall pooled effects of adjuvant acupuncture on IVF clinical pregnancy success rates, and evaluate whether study design-, treatment- and population-related factors influence effect estimates. METHODS We included randomized controlled trials that compared needle acupuncture administered within 1 day of embryo transfer, versus sham acupuncture or no adjuvant treatment. Our primary outcome was clinical pregnancy rates. We obtained from all investigators additional methodological details and outcome data not included in their original publications. We analysed sham-controlled and no adjuvant treatment-controlled trials separately, but since there were no large or significant differences between these two subsets, we pooled all trials for subgroup analyses. We prespecified 11 subgroup variables (5 clinical and 6 methodological) to investigate sources of heterogeneity, using single covariate meta-regressions. RESULTS Sixteen trials (4021 participants) were included in the meta-analyses. There was no statistically significant difference between acupuncture and controls when combining all trials risk ratio (RR) 1.12, 95% confidence interval (CI), 0.96-1.31; I(2) = 68%; 16 trials; 4021 participants, or when restricting to sham-controlled (RR 1.02, 0.83-1.26; I(2) = 66%; 7 trials; 2044 participants) or no adjuvant treatment-controlled trials (RR 1.22, 0.97-1.52; I(2) = 67%; 9 trials; 1977 participants). The type of control used did not significantly explain the statistical heterogeneity (interaction P = 0.27). Baseline pregnancy rate, measured as the observed rate of clinical pregnancy in the control group of each trial, was a statistically significant effect modifier (interaction P < 0.001), and this covariate explained most of the heterogeneity of the effects of adjuvant acupuncture across all trials (adjusted R(2) = 93%; I(2) residual = 9%). Trials with lower control group rates of clinical pregnancy showed larger effects of adjuvant acupuncture (RR 1.53, 1.28-1.84; 7 trials; 1732 participants) than trials with higher control group rates of clinical pregnancy (RR 0.90, 0.80-1.01; 9 trials; 2289 participants). The asymmetric funnel plot showed a tendency for the intervention effects to be more beneficial in smaller trials. CONCLUSIONS We found no pooled benefit of adjuvant acupuncture for IVF. The subgroup finding of a benefit in trials with lower, but not higher, baseline pregnancy rates (the only statistically significant subgroup finding in our earlier review) has been confirmed in this update, and was not explained by any confounding variables evaluated. However, this baseline pregnancy rate subgroup finding among published trials requires further confirmation and exploration in additional studies because of the multiple subgroup tests conducted, the risk of unidentified confounders, the multiple different factors that determine baseline rates, and the possibility of publication bias.
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