Massage for neck pain.

BACKGROUND: Massage is widely used for neck pain, but its effectiveness remains unclear. OBJECTIVES: To assess the benefits and harms of massage compared to placebo or sham, no treatment or exercise as an adjuvant to the same co-intervention for acute to chronic persisting neck pain in adults with or without radiculopathy, including whiplash-associated disorders and cervicogenic headache. SEARCH METHODS: We searched multiple databases (CENTRAL, MEDLINE, EMBASE, CINAHL, Index to Chiropractic Literature, trial registries) to 1 October 2023. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing any type of massage with sham or placebo, no treatment or wait-list, or massage as an adjuvant treatment, in adults with acute, subacute or chronic neck pain. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. We transformed outcomes to standardise the direction of the effect (a smaller score is better). We used a partially contextualised approach relative to identified thresholds to report the effect size as slight-small, moderate or large-substantive. MAIN RESULTS: We included 33 studies (1994 participants analysed). Selection (82%) and detection bias (94%) were common; multiple trials had unclear allocation concealment, utilised a placebo that may not be credible and did not test whether blinding to the placebo was effective. Massage was compared with placebo (n = 10) or no treatment (n = 8), or assessed as an adjuvant to the same co-treatment (n = 15). The trials studied adults aged 18 to 70 years, 70% female, with mean pain severity of 51.8 (standard deviation (SD) 14.1) on a visual analogue scale (0 to 100). Neck pain was subacute-chronic and classified as non-specific neck pain (85%, including n = 1 whiplash), radiculopathy (6%) or cervicogenic headache (9%). Trials were conducted in outpatient settings in Asia (n = 11), America (n = 5), Africa (n = 1), Europe (n = 12) and the Middle East (n = 4). Trials received research funding (15%) from research institutes. We report the main results for the comparison of massage versus placebo. Low-certainty evidence indicates that massage probably results in little to no difference in pain, function-disability and health-related quality of life when compared against a placebo for subacute-chronic neck pain at up to 12 weeks follow-up. It may slightly improve participant-reported treatment success. Subgroup analysis by dose showed a clinically important difference favouring a high dose (≥ 8 sessions over four weeks for ≥ 30 minutes duration). There is very low-certainty evidence for total adverse events. Data on patient satisfaction and serious adverse events were not available. Pain was a mean of 20.55 points with placebo and improved by 3.43 points with massage (95% confidence interval (CI) 8.16 better to 1.29 worse) on a 0 to 100 scale, where a lower score indicates less pain (8 studies, 403 participants; I2 = 39%). We downgraded the evidence to low-certainty due to indirectness; most trials in the placebo comparison used suboptimal massage doses (only single sessions). Selection, performance and detection bias were evident as multiple trials had unclear allocation concealment, utilised a placebo that may not be credible and did not test whether blinding was effective, respectively. Function-disability was a mean of 30.90 points with placebo and improved by 9.69 points with massage (95% CI 17.57 better to 1.81 better) on the Neck Disability Index 0 to 100, where a lower score indicates better function (2 studies, 68 participants; I2 = 0%). We downgraded the evidence to low-certainty due to imprecision (the wide CI represents slight to moderate benefit that does not rule in or rule out a clinically important change) and risk of selection, performance and detection biases. Participant-reported treatment success was a mean of 3.1 points with placebo and improved by 0.80 points with massage (95% CI 1.39 better to 0.21 better) on a Global Improvement 1 to 7 scale, where a lower score indicates very much improved (1 study, 54 participants). We downgraded the evidence to low-certainty due to imprecision (single study with a wide CI that does not rule in or rule out a clinically important change) and risk of performance as well as detection bias. Health-related quality of life was a mean of 43.2 points with placebo and improved by 5.30 points with massage (95% CI 8.24 better to 2.36 better) on the SF-12 (physical) 0 to 100 scale, where 0 indicates the lowest level of health (1 study, 54 participants). We downgraded the evidence once for imprecision (a single small study) and risk of performance and detection bias. We are uncertain whether massage results in increased total adverse events, such as treatment soreness, sweating or low blood pressure (RR 0.99, 95% CI 0.08 to 11.55; 2 studies, 175 participants; I2 = 77%). We downgraded the evidence to very low-certainty due to unexplained inconsistency, risk of performance and detection bias, and imprecision (the CI was extremely wide and the total number of events was very small, i.e < 200 events). AUTHORS' CONCLUSIONS: The contribution of massage to the management of neck pain remains uncertain given the predominance of low-certainty evidence in this field. For subacute and chronic neck pain (closest to 12 weeks follow-up), massage may result in a little or no difference in improving pain, function-disability, health-related quality of life and participant-reported treatment success when compared to a placebo. Inadequate reporting on adverse events precluded analysis. Focused planning for larger, adequately dosed, well-designed trials is needed.

Community-based group physical activity and/or nutrition interventions to promote mobility in older adults: an umbrella review.

BACKGROUND: Physical activity and a healthy diet are important in helping to maintain mobility with aging. This umbrella review aims to identify group-based physical activity and/or nutrition interventions for community-dwelling older adults that improve mobility-related outcomes. METHODS: Five electronic databases (MEDLINE, Embase, CINAHL, Cochrane CENTRAL, Sociological Abstracts) were searched from inception to December 2021. Eligibility criteria included systematic reviews exploring the effectiveness of physical activity or structured exercise, alone or combined with nutrition interventions on mobility-related outcomes (aerobic capacity, physical function, balance, falls/safety, muscle strength, health-related quality of life/wellbeing). Interventions must have been delivered in a group setting to community-dwelling older adults aged 55+. Two reviewers independently performed eligibility screening, critical appraisal (using AMSTAR 2) and data extraction. The GRADE approach was used to reflect the certainty of evidence based on the size of the effect within each mobility-related outcome category. Older adult/provider research partners informed data synthesis and results presentation. RESULTS: In total, 62 systematic reviews (1 high, 21 moderate, 40 low/critically low quality) were identified; 53 included physical activity only, and nine included both physical activity and nutritional supplements. No reviews included nutrition interventions alone. Combined aerobic/resistance, general physical activity, and mind-body exercise all improved physical function and balance (moderate-high certainty). Aerobic/resistance training improved aerobic capacity (high certainty). Resistance training and general physical activity improved muscle strength (moderate certainty). Aerobic/resistance training and general physical activity are likely to reduce falls among older adults (moderate certainty). There was no evidence of benefit for nutritional supplementation with physical activity. CONCLUSIONS: Group-based physical activity interventions that combine aerobic and resistance, general PA and mind-body exercise can improve measures of mobility in community-dwelling older adults. We found no reviews focused on nutrition only, highlighting a gap in the literature.

A systematic review of interventions for treatment resistant major depressive disorder in adolescents.

To update a comparative effectiveness review (1980-2011) of treatments for adolescents whose depressive episode or disorder (MDE/MDD) did not respond to one or more trials of SSRI antidepressants. MEDLINE, Cochrane Central, PsychINFO, Cochrane Database of Systematic Reviews, EMBASE, CINAHL, and AMED were searched in addition to the grey literature. We spanned May 2011 to September 1, 2017 and included only articles in English. 11 new studies were reviewed based on the criteria of having tested a comparative treatment in adolescents with MDD or MDE who were confirmed to have failed one or more SSRI trials. Data were extracted using standardized forms and a reference guide in DistillerSR; a second reviewer verified the accuracy of the data fields and discrepancies were resolved by consensus. One trial (N = 29) found a small benefit of escalating doses of fluoxetine and the treatment of adolescent depression study (TORDIA, N = 334) found significant benefits of combined SSRI or venlafaxine treatment with CBT for most outcomes. No new studies were identified since the previous review (2012). One trial is currently registered that will be a cross over trial of rTMS; other registered trials are open label. Multiple secondary data analyses of TORDIA have identified important predictors of treatment response and relapse. No new comparative studies were identified since the original review. Trials are desperately needed to identify new treatments for youth with SSRI resistant MDD. These youth should not be deemed as treatment resistant until completing one or two failed trials of SSRI combined with evidence-based psychotherapy.

Exercises for mechanical neck disorders.

BACKGROUND: Neck pain is common, disabling and costly. Exercise is one treatment approach. OBJECTIVES: To assess the effectiveness of exercises to improve pain, disability, function, patient satisfaction, quality of life and global perceived effect in adults with neck pain. SEARCH METHODS: We searched MEDLINE, MANTIS, ClinicalTrials.gov and three other computerized databases up to between January and May 2014 plus additional sources (reference checking, citation searching, contact with authors). SELECTION CRITERIA: We included randomized controlled trials (RCTs) comparing single therapeutic exercise with a control for adults suffering from neck pain with or without cervicogenic headache or radiculopathy. DATA COLLECTION AND ANALYSIS: Two review authors independently conducted trial selection, data extraction, 'Risk of bias' assessment and clinical relevance. The quality of the evidence was assessed using GRADE. Meta-analyses were performed for relative risk and standardized mean differences (SMD) with 95% confidence intervals (CIs) after judging clinical and statistical heterogeneity. MAIN RESULTS: Twenty-seven trials (2485 analyzed /3005 randomized participants) met our inclusion criteria.For acute neck pain only, no evidence was found.For chronic neck pain, moderate quality evidence supports 1) cervico-scapulothoracic and upper extremity strength training to improve pain of a moderate to large amount immediately post treatment [pooled SMD (SMDp) -0.71 (95% CI: -1.33 to -0.10)] and at short-term follow-up; 2) scapulothoracic and upper extremity endurance training for slight beneficial effect on pain at immediate post treatment and short-term follow-up; 3) combined cervical, shoulder and scapulothoracic strengthening and stretching exercises varied from a small to large magnitude of beneficial effect on pain at immediate post treatment [SMDp -0.33 (95% CI: -0.55 to -0.10)] and up to long-term follow-up and a medium magnitude of effect improving function at both immediate post treatment and at short-term follow-up [SMDp -0.45 (95%CI: -0.72 to -0.18)]; 4) cervico-scapulothoracic strengthening/stabilization exercises to improve pain and function at intermediate term [SMDp -14.90 (95% CI:-22.40 to -7.39)]; 5) Mindfulness exercises (Qigong) minimally improved function but not global perceived effect at short term. Low evidence suggests 1) breathing exercises; 2) general fitness training; 3) stretching alone; and 4) feedback exercises combined with pattern synchronization may not change pain or function at immediate post treatment to short-term follow-up. Very low evidence suggests neuromuscular eye-neck co-ordination/proprioceptive exercises may improve pain and function at short-term follow-up.For chronic cervicogenic headache, moderate quality evidence supports static-dynamic cervico-scapulothoracic strengthening/endurance exercises including pressure biofeedback immediate post treatment and probably improves pain, function and global perceived effect at long-term follow-up. Low grade evidence supports sustained natural apophyseal glides (SNAG) exercises.For acute radiculopathy, low quality evidence suggests a small benefit for pain reduction at immediate post treatment with cervical stretch/strengthening/stabilization exercises. AUTHORS' CONCLUSIONS: No high quality evidence was found, indicating that there is still uncertainty about the effectiveness of exercise for neck pain. Using specific strengthening exercises as a part of routine practice for chronic neck pain, cervicogenic headache and radiculopathy may be beneficial. Research showed the use of strengthening and endurance exercises for the cervico-scapulothoracic and shoulder may be beneficial in reducing pain and improving function. However, when only stretching exercises were used no beneficial effects may be expected. Future research should explore optimal dosage.

Incremental value of natriuretic peptide measurement in acute decompensated heart failure (ADHF): a systematic review.

The aim of this systematic review was to determine whether B-type natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP) independently add incremental value for predicting mortality and morbidity in patients with acute decompensated heart failure (ADHF). Medline(®), Embase™, AMED, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and CINAHL were searched from 1989 to June 2012. We also searched reference lists of included articles, systematic reviews, and the gray literature. Studies were screened for eligibility criteria and assessed for risk of bias. Data were extracted on study design, population demographics, assay cutpoints, prognostic risk prediction model covariates, statistical methods, outcomes, and results. From 183 citations, only seven studies (5 BNP and 2 NT-proBNP) considered incremental value in ADHF subjects admitted to acute care centers. Admission assay levels and length of follow-up varied for BNP studies (31 days to 12 months) and for NT-proBNP studies (25-82 months). All studies presented at least one estimate of incremental value of BNP/NT-proBNP relative to the base prognostic model. Using discrimination or likelihood statistics, these studies consistently showed that BNP or NT-proBNP increased model performance. Three studies used reclassification and model validation computations to establish incremental value; these studies showed less consistency with respect to added value. In conclusion, the literature assessing incremental value of BNP/NT-proBNP in ADHF populations is limited to seven studies evaluating only mortality outcomes and at moderate risk of bias. Although there were differences in the base risk prediction models, assay cutpoints, and lengths of follow-up, there was consistency in BNP/NT-proBNP adding incremental value in prediction models in ADHF patients.

Prediction of clinical outcomes using B-type natriuretic peptides in the general population: a systematic review.

The use of B-type natriuretic peptides to predict outcomes in general populations has been investigated in a number of primary studies. A previous systematic review considering natriuretic peptides in cardiovascular disease included a subgroup of general population studies, which suggested an association with a number of clinical outcomes. We electronically searched Medline, Embase, AMED, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and CINAHL for English-language articles published between 1989 and mid-2012. We utilized trained reviewers and standardized forms to screen articles for inclusion and extract data from included articles. All included studies (n = 7) were summarized in narrative and tabular form. A general population was defined as one that was randomly selected from a community setting where no specific inclusion or exclusion criteria were specified. The seven included studies all used FDA approved assays for NT-proBNP. The range of clinical outcomes and heterogeneity did not allow for meta-analysis. The hazard ratios for predicting outcomes in the included studies ranged from 1.0 to 4.1 (all p values <0.05). The discrimination statistics reported in four studies all demonstrated statistically significant improvements in predicting outcomes. NT-proBNP is associated with heart failure, all-cause and cardiovascular mortality, and other combined cardiovascular events in a general unselected population. The discrimination statistics suggest modest improvements in risk stratification. No prospective studies exist to demonstrate the clinical utility of using B-type natriuretic peptides to predict clinical outcomes in a general population.

BNP and NT-proBNP as prognostic markers in persons with chronic stable heart failure.

Prognosis permits clinicians to separate persons with heart failure (HF) into subgroups based on likely health outcomes. Treatment is partly guided by these likely outcomes. This systematic review explores whether brain natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP) are independent predictors of prognosis in persons with chronic stable HF. We electronically searched Medline, Embase, AMED, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and CINAHL for English-language articles published between 1989 and mid-2012. We utilized trained reviewers and standardized forms to screen articles for inclusion and extracted data from included articles. All included studies were summarized in narrative and tabular form. We used the Hayden criteria to assess the risk of bias. Sixteen BNP publications and 88 NT-proBNP publications were included in the systematic review. BNP was positively associated with all-cause and HF mortality. NT-proBNP was positively associated with all-cause and cardiovascular mortality. BNP and NT-proBNP levels are useful for estimating prognosis in persons with chronic stable HF. Further research is required to establish optimal cutpoints and to assess whether prognostic effects differ by age, sex, or time period.

A systematic review of BNP and NT-proBNP in the management of heart failure: overview and methods.

B-type natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP) levels are increased in persons with heart failure (HF); low levels of these peptides rule out HF. We systematically reviewed the literature to assess the use of BNP and NT-proBNP in the diagnosis, prognosis, and treatment for HF. We also examined the biological variation of these peptides in persons with and without HF. We searched Medline, Embase, AMED, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and CINAHL for English-language studies published between January 1989 and June 2012. Supplemental searches involved the gray literature and the reference lists of included studies. Trained reviewers used standardized forms to screen articles for inclusion in the review and to extract data from included papers. We examined the risk of bias with QUADAS-2 for diagnosis studies, the Hayden criteria for prognosis studies, and the Jadad scale for treatment studies. We assessed the strength of evidence in four domains (risk of bias, consistency, directness, and precision) for the diagnosis and treatment studies. Results were reported as narrative syntheses. Additional meta-analyses were conducted for the diagnosis studies. Three hundred ten articles passed through screening and were included in the review. One hundred four articles applied to diagnostic accuracy, 190 papers pertained to prognosis, and nine articles addressed BNP- or NT-proBNP-guided treatment. Each individual paper in this series reports, summarizes, and discusses the evidence regarding diagnosis, prognosis, or treatment.

B-type natriuretic peptide-guided therapy: a systematic review.

BNP/NT-proBNP measurement has not gained widespread use for the management of patients with heart failure (HF) despite several randomized controlled trials. A systematic review addressing the question of whether patients with HF benefit from BNP-assisted therapy or intensified therapy compared with usual care was undertaken. Relevant randomized controlled trial (RCTs) were selected by searching Medline, Embase, AMED, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and CINAHL for English-language articles published from 1980 to 2012. Selected studies required patients to be treated for chronic HF with medical therapy based on BNP/NT-proBNP or usual care. There were no restrictions except that BNP/NT-proBNP measurement had to be done by an FDA approved method. Nine RCTs were identified with 2,104 patients with study duration that ranged from 3 to 18 months. Overall, there was a wide variation in study design and how parameters were reported including patient selection, baseline characteristics, therapy goals, BNP/NT-proBNP cutpoint, and outcome types. Meta-analysis was not appropriate given this study heterogeneity. The strength of evidence for the outcome of mortality, reported in seven studies, was found to be low due to inconsistency and imprecision. This systematic review showed that the evidence is of low quality and insufficient to support the use of BNP/NT-proBNP to guide HF therapy. Further trials with improved design are needed.

BNP and NT-proBNP as prognostic markers in persons with acute decompensated heart failure: a systematic review.

A systematic review was undertaken to examine the evidence for B-type natriuretic peptides (BNP and NT-proBNP) as independent predictors of mortality, morbidity, or combined mortality and morbidity outcomes in persons with acute decompensated heart failure (ADHF). Electronic databases (Medline(®), Embase™, AMED, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and CINAHL) were searched from 1989 to June 2012. Reference lists of included articles, systematic reviews, and the gray literature were also searched. English language studies were eligible if they included subjects with ADHF and measured BNP/NT-proBNP using FDA approved assays. Standardized forms were used to select studies, extract data, and assess risk of bias. Seventy-nine studies, ranging over followup intervals from 14 days to 7 years, evaluating levels of BNP (n = 38), NT-proBNP (n = 35), or both (n = 6) were eligible. The majority of studies predicted mortality outcomes for admission BNP/NT-proBNP levels, with fewer studies evaluating serial, change from admission, or discharge levels. In general, higher levels of admission BNP or NT-proBNP predicted greater risk for all outcomes. Decreased levels post-admission predicted decreased risk. Overall, these studies were rated as having moderate risk of bias. This systematic review shows that BNP and NT-proBNP are independent predictors of mortality (all-cause and cardiovascular) in ADHF despite different cutpoints, time intervals, and prognostic models. Findings for morbidity and composite outcomes were less frequently evaluated and showed inconsistency. Further research is required to assess cutpoints for admission, serial measurements, change following admission, and discharge levels to assist clinical decision-making.

Incremental predictive value of natriuretic peptides for prognosis in the chronic stable heart failure population: a systematic review.

The aim of this study was to determine whether measurement of natriuretic peptides independently adds incremental predictive value for mortality and morbidity in patients with chronic stable heart failure (CSHF). We electronically searched Medline®, Embase™, AMED, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and CINAHL from 1989 to June 2012. We also searched reference lists of included articles, systematic reviews, and the gray literature. Studies were screened for eligibility criteria and assessed for methodological quality. Data were extracted on study design, population demographics, assay cutpoints, prognostic risk prediction model covariates, statistical methods, outcomes, and results. One hundred and eighty-three studies were identified as prognostic in the systematic review. From these, 15 studies (all NT-proBNP) considered incremental predictive value in CSHF subjects. Follow-up varied from 12 to 37 months. All studies presented at least one estimate of incremental predictive value of NT-proBNP relative to the base prognostic model. Using discrimination or likelihood statistics, these studies consistently showed that NT-proBNP increased model performance. Three studies used re-classification and model validation computations to establish incremental predictive value; these studies showed less consistency with respect to added value. Although there were differences in the base risk prediction models, assay cutpoints, and lengths of follow-up, there was consistency in NT-proBNP adding incremental predictive value for prognostic models in chronic stable CSHF patients. The limitations in the literature suggest that studies designed to evaluate prognostic models should be undertaken to evaluate the incremental value of natriuretic peptide as a predictor of mortality and morbidity in CSHF.

Chapter 8: meta-analysis of test performance when there is a "gold standard".

Synthesizing information on test performance metrics such as sensitivity, specificity, predictive values and likelihood ratios is often an important part of a systematic review of a medical test. Because many metrics of test performance are of interest, the meta-analysis of medical tests is more complex than the meta-analysis of interventions or associations. Sometimes, a helpful way to summarize medical test studies is to provide a "summary point", a summary sensitivity and a summary specificity. Other times, when the sensitivity or specificity estimates vary widely or when the test threshold varies, it is more helpful to synthesize data using a "summary line" that describes how the average sensitivity changes with the average specificity. Choosing the most helpful summary is subjective, and in some cases both summaries provide meaningful and complementary information. Because sensitivity and specificity are not independent across studies, the meta-analysis of medical tests is fundamentaly a multivariate problem, and should be addressed with multivariate methods. More complex analyses are needed if studies report results at multiple thresholds for positive tests. At the same time, quantitative analyses are used to explore and explain any observed dissimilarity (heterogeneity) in the results of the examined studies. This can be performed in the context of proper (multivariate) meta-regressions.

Exercises for mechanical neck disorders.

BACKGROUND: Neck disorders are common, disabling and costly. The effectiveness of exercise as a physiotherapy intervention remains unclear. OBJECTIVES: To improve pain, disability, function, patient satisfaction, quality of life and global perceived effect in adults with neck pain. SEARCH METHODS: Computerized searches were conducted up to February 2012. SELECTION CRITERIA: We included single therapeutic exercise randomized controlled trials for adults with neck pain with or without cervicogenic headache or radiculopathy. DATA COLLECTION AND ANALYSIS: Two review authors independently conducted selection, data extraction, 'Risk of bias' assessment, and clinical relevance. The quality of the body of evidence was assessed using GRADE. Relative risk and standardized mean differences (SMD) were calculated.  After judging clinical and statistical heterogeneity, we performed meta-analyses. MAIN RESULTS: Six of the 21 selected trials had low risk of bias. Moderate quality evidence shows that combined cervical, scapulothoracic stretching and strengthening are beneficial for pain relief post treatment (pooled SMD -0.35, 95% confidence interval (CI): -0.60, -0.10) and at intermediate follow-up (pooled SMD -0.31, 95% CI: -0.57, -0.06), and improved function short term and intermediate term (pooled SMD -0.45, 95% CI: -0.72, -0.18) for chronic neck pain. Moderate quality evidence demonstrates patients are very satisfied with their care when treated with therapeutic exercise. Low quality evidence shows exercise is of benefit for pain in the short term and for function up to long-term follow-up for chronic neck pain. Low to moderate quality evidence shows that chronic neck pain does not respond to upper extremity stretching and strengthening or a general exercise program.Low to moderate quality evidence supports self-mobilization, craniocervical endurance and low load cervical-scapular endurance exercises in reducing pain, improving function and global perceived effect in the long term for subacute/chronic cervicogenic headache. Low quality evidence supports neck strengthening exercise in acute cervical radiculopathy for pain relief in the short term. AUTHORS' CONCLUSIONS: Low to moderate quality evidence supports the use of specific cervical and scapular stretching and strengthening exercise for chronic neck pain immediately post treatment and intermediate term, and cervicogenic headaches in the long term. Low to moderate evidence suggests no benefit for some upper extremity stretching and strengthening exercises or a general exercise program.  Future trials should consider using an exercise classification system to establish similarity between protocols and adequate sample sizes. Factorial trials would help determine the active treatment agent within a treatment regimen where a standardized representation of dosage is essential. Standardized reporting of adverse events is needed for balancing the likelihood of treatment benefits over potential harms.

Delphi consensus on core criteria set selecting among health-related outcome measures (HROM) in primary health care.

OBJECTIVES: There has been a lack of consensus on which criteria are important when selecting health-related outcome measures (HROM), especially in primary health care A Delphi consensus was undertaken to identify core criteria for selecting among different HROM and contextual factors affecting decision-making. STUDY DESIGN AND SETTING: A Delphi survey using standard methodology (consensus set as 75% agreement) was sent to primary care practitioners, administrators, policymakers, researchers and experts in HROM development. Criteria (n = 35) were selected from a targeted literature search; questions probed contextual factors that may influence selection of core criteria including the following: 1) weighting, 2) clinical contexts, and 3) core areas. RESULTS: Participants (n = 45) achieved consensus on 17 items in round 1 (plus four new criteria), with one more item in round 2. Unequal weighting of criteria was favored, and the type of clinical scenario did not influence selection of HROM. CONCLUSION: Eighteen core criteria from 39 were identified for inclusion in a core set, reflected predominately aspects of feasibility and acceptability. This is the first study providing evidence that contextual factors affect selection of HROM in a core criteria set. Care in primary health care is complex, and therefore, the items not reaching consensus may reflect this heterogeneity.

Patient characteristics affecting the prognosis of total hip and knee joint arthroplasty: a systematic review.

BACKGROUND: Total joint arthroplasty is a highly efficacious and cost-effective procedure for moderate to severe arthritis in the hip and knee. Although patient characteristics are considered to be important determinants of who receives total joint arthroplasty, no systematic review has addressed how they affect the outcomes of total joint arthroplasty. This study addresses how patient characteristics influence the outcomes of hip and knee arthroplasty in patients with osteoarthritis. METHODS: We searched 4 bibliographic databases (MEDLINE 1980-2001, CINAHL 1982-2001, EMBASE 1980-2001, HealthStar 1998-1999) for studies involving more than 500 patients with osteoarthritis and 1 or more of the following outcomes after total joint arthroplasty: pain, physical function, postoperative complications (short-and long-term) and time to revision. Prognostic patient characteristics of interest included age, sex, race, body weight, socioeconomic status and work status. RESULTS: Sixty-four of 14,276 studies were eligible for inclusion and had extractable data. Younger age (variably defined) and male sex increased the risk of revision 3-fold to 5-fold for hip and knee arthroplasty. The influence of weight on the risk of revision was contradictory. Mortality was greatest in the oldest age group and among men. Function for older patients was worse after hip arthroplasty (particularly in women). Function after knee arthroplasty was worse for obese patients. CONCLUSION: Although further research is required, our findings suggest that, after total joint arthroplasty, younger age and male sex are associated with increased risk of revision, older age and male sex are associated with increased risk of mortality, older age is related to worse function (particularly among women), and age and sex do not influence the outcome of pain. Despite these findings, all subgroups derived benefit from total joint arthroplasty, suggesting that surgeons should not restrict access to these procedures based on patient characteristics. In addition, future research needs to provide standardized measures of outcomes.

Comparison of cumulative low back loads of caregivers when transferring patients using overhead and floor mechanical lifting devices.

BACKGROUND: Mechanical lifting devices are recommended as an important intervention for reducing lifting injuries among nursing personnel; previous research suggests that spinal loads are not minimized for all device types. The purpose of this study was to describe the spinal loading pattern while performing a bed to chair transfer comparing Overhead and Floor powered lifting devices. METHODS: A Latin Square design was employed to evaluate five lifting devices while performing a heavy patient transfer. The primary outcomes were spinal compression, and anterior shear (across median and cumulative loading conditions), and ratings of perceived exertion. An inverse dynamic approach was used to calculate the net joint forces and moments about the L5/S1 spinal level. The transfer was partitioned into seven distinct phases for biomechanical analysis. FINDINGS: The proportion of time spent and the mean loads sustained in each phase of the transfer were described. Significant differences in loads were observed between the differing lifting devices, particularly during the transport phases for the Overhead devices. Nurse subjects consistently ranked Overhead lifting devices as most preferred. INTERPRETATION: A large proportion of the time to complete the transfer and cumulative loads occurred during phases that involved only the sling and not the mechanical component of the device. Overhead lifting devices were shown to have lower spinal loads during the transport phases. The results of this study have implications for the use and selection of mechanical lifting devices as part of a strategy to reduce back injuries.

Grading Evidence for Laboratory Test Studies Beyond Diagnostic Accuracy: Application to Prognostic Testing.

BACKGROUND: Evidence-based guideline development requires transparent methodology for gathering, synthesizing and grading the quality and strength of evidence behind recommendations. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) project has addressed diagnostic test use in many of their publications. Most of the work has been directed at diagnostic tests and no consensus has been reached for prognostic biomarkers. AIM OF THIS PAPER: The GRADE system for rating the quality of evidence and the strength of a recommendation is described. The application of GRADE to diagnostic testing is discussed and a description of application to prognostic testing is detailed. Some strengths and limitations of the GRADE process in relation to clinical laboratory testing are presented. CONCLUSIONS: The GRADE system is applicable to clinical laboratory testing and if correctly applied should improve the reporting of recommendations for clinical laboratory tests by standardising the style of recommendation and by encouraging transparent reporting of the actual guideline process.