Catherine Hewitt

Screening for depression in medical settings with the Patient Health Questionnaire (PHQ): A diagnostic meta-analysis.

ObjectiveTo summarize the psychometric properties of the PHQ2 and PHQ9 as screening instruments for depression.InterventionsWe identified 17 validation studies conducted in primary care; medical outpatients; and specialist medical services (cardiology, gynecology, stroke, dermatology, head injury, and otolaryngology). Electronic databases from 1994 to February 2007 (MEDLINE, PsycLIT, EMBASE, CINAHL, Cochrane registers) plus study reference lists have been used for this study. Translations included US English, Dutch, Italian, Spanish, German and Arabic). Summary sensitivity, specificity, likelihood and diagnostic odds ratios (OR) against a gold standard (DSM-IV) Major Depressive Disorder (MDD) were calculated for each study. We used random effects bivariate meta-analysis at recommended cut points to produce summary receiver–operator characteristic (sROC) curves. We explored heterogeneity with metaregression.Measurements and Main ResultsFourteen studies (5,026 participants) validated the PHQ9 against MDD: sensitivity = 0.80 (95% CI 0.71–0.87); specificity = 0.92 (95% CI 0.88–0.95); positive likelihood ratio = 10.12 (95% CI 6.52–15.67); negative likelihood ratio = 0.22 (0.15 to 0.32). There was substantial heterogeneity (Diagnostic Odds Ratio heterogeneity I2 = 82%), which was not explained by study setting (primary care versus general hospital); method of scoring (cutoff ≥ 10 versus “diagnostic algorithm”); or study quality (blinded versus unblinded). The diagnostic validity of the PHQ2 was only validated in 3 studies and showed wide variability in sensitivity.ConclusionsThe PHQ9 is acceptable, and as good as longer clinician-administered instruments in a range of settings, countries, and populations. More research is needed to validate the PHQ2 to see if its diagnostic properties approach those of the PHQ9.

Dietary protein and bone health: a systematic review and meta-analysis

BACKGROUND There has been a resurgence of interest in the controversial relation between dietary protein and bone health. OBJECTIVE This article reports on the first systematic review and meta-analysis of the relation between protein and bone health in healthy human adults. DESIGN The MEDLINE (January 1966 to September 2007) and EMBASE (1974 to July 2008) databases were electronically searched for all relevant studies of healthy adults; studies of calcium excretion or calcium balance were excluded. RESULTS In cross-sectional surveys, all pooled r values for the relation between protein intake and bone mineral density (BMD) or bone mineral content at the main clinically relevant sites were significant and positive; protein intake explained 1-2% of BMD. A meta-analysis of randomized placebo-controlled trials indicated a significant positive influence of all protein supplementation on lumbar spine BMD but showed no association with relative risk of hip fractures. No significant effects were identified for soy protein or milk basic protein on lumbar spine BMD. CONCLUSIONS A small positive effect of protein supplementation on lumbar spine BMD in randomized placebo-controlled trials supports the positive association between protein intake and bone health found in cross-sectional surveys. However, these results were not supported by cohort study findings for hip fracture risk. Any effects found were small and had 95% CIs that were close to zero. Therefore, there is a small benefit of protein on bone health, but the benefit may not necessarily translate into reduced fracture risk in the long term.

Methods to identify postnatal depression in primary care: an integrated evidence synthesis and value of information analysis.

OBJECTIVES To provide an overview of methods to identify postnatal depression (PND) in primary care and to assess their validity, acceptability, clinical effectiveness and cost-effectiveness, to model estimates of cost, to assess whether any method meets UK National Screening Committee (NSC) criteria and to identify areas for future research. DATA SOURCES Searches of 20 electronic databases (including MEDLINE, CINAHL, PsycINFO, EMBASE, CENTRAL, DARE and CDSR), forward citation searching, personal communication with authors and searching of reference lists. REVIEW METHODS A generalised linear mixed model approach to the bivariate meta-analysis was undertaken for the validation review with quality assessment using QUADAS. Within the acceptability review, a textual narrative approach was employed to synthesise qualitative and quantitative research evidence. For the clinical and cost-effectiveness reviews methods outlined by the Centre for Reviews and Dissemination and the Cochrane Collaboration were followed. Probabilistic models were developed to estimate the costs associated with different identification strategies. RESULTS The Edinburgh Postnatal Depression Scale (EPDS) was the most frequently explored instrument across all of the reviews. In terms of test performance, postnatally the EPDS performed reasonably well: sensitivity ranged from 0.60 (specificity 0.97) to 0.96 (specificity 0.45) for major depression only; from 0.31 (specificity 0.99) to 0.91 (specificity 0.67) for major or minor depression; and from 0.38 (specificity 0.99) to 0.86 (specificity 0.87) for any psychiatric disorder. Evidence from the acceptability review indicated that, in the majority of studies, the EPDS was acceptable to women and health-care professionals when women were forewarned of the process, when the EPDS was administered in the home, with due attention to training, with empathetic skills of the health visitor and due consideration to positive responses to question 10 about self-harm. Suggestive evidence from the clinical effectiveness review indicated that use of the EPDS, compared with usual care, may lead to reductions in the number of women with depression scores above a threshold. In the absence of existing cost-effectiveness studies of PND identification strategies, a decision-analytic model was developed. The results of the base-case analysis suggested that use of formal identification strategies did not appear to represent value for money, based on conventional thresholds of cost-effectiveness used in the NHS. However, the scenarios considered demonstrated that this conclusion was primarily driven by the costs of false positives assumed in the base-case model. CONCLUSIONS In light of the results of our evidence synthesis and decision modelling we revisited the examination of PND screening against five of the NSC criteria. We found that the accepted criteria for a PND screening programme were not currently met. The evidence suggested that there is a simple, safe, precise and validated screening test, in principle a suitable cut-off level could be defined and that the test is acceptable to the population. Evidence surrounding clinical and cost-effectiveness of methods to identify PND is lacking. Further research should aim to identify the optimal identification strategy, in terms of key psychometric properties for postnatal populations. In particular, research comparing the performance of the Whooley and help questions, the EPDS and a generic depression measure would be informative. It would also be informative to identify the natural history of PND over time and to identify the clinical effectiveness of the most valid and acceptable method to identify postnatal depression. Further research within a randomised controlled trial would provide robust estimates of the clinical effectiveness.

Reporting attrition in randomised controlled trials

Loss to follow-up can greatly affect the strength of a trials findings. But most reports do not give readers enough information for them to be able to understand the potential effects

Yoga for chronic low back pain: A randomized trial

BACKGROUND Previous studies indicate that yoga may be an effective treatment for chronic or recurrent low back pain. OBJECTIVE To compare the effectiveness of yoga and usual care for chronic or recurrent low back pain. DESIGN Parallel-group, randomized, controlled trial using computer-generated randomization conducted from April 2007 to March 2010. Outcomes were assessed by postal questionnaire. (International Standard Randomised Controlled Trial Number Register: ISRCTN 81079604) SETTING 13 non-National Health Service premises in the United Kingdom. PATIENTS 313 adults with chronic or recurrent low back pain. INTERVENTION Yoga (n = 156) or usual care (n = 157). All participants received a back pain education booklet. The intervention group was offered a 12-class, gradually progressing yoga program delivered by 12 teachers over 3 months. MEASUREMENTS Scores on the Roland-Morris Disability Questionnaire (RMDQ) at 3 (primary outcome), 6, and 12 (secondary outcomes) months; pain, pain self-efficacy, and general health measures at 3, 6, and 12 months (secondary outcomes). RESULTS 93 (60%) patients offered yoga attended at least 3 of the first 6 sessions and at least 3 other sessions. The yoga group had better back function at 3, 6, and 12 months than the usual care group. The adjusted mean RMDQ score was 2.17 points (95% CI, 1.03 to 3.31 points) lower in the yoga group at 3 months, 1.48 points (CI, 0.33 to 2.62 points) lower at 6 months, and 1.57 points (CI, 0.42 to 2.71 points) lower at 12 months. The yoga and usual care groups had similar back pain and general health scores at 3, 6, and 12 months, and the yoga group had higher pain self-efficacy scores at 3 and 6 months but not at 12 months. Two of the 157 usual care participants and 12 of the 156 yoga participants reported adverse events, mostly increased pain. LIMITATION There were missing data for the primary outcome (yoga group, n = 21; usual care group, n = 18) and differential missing data (more in the yoga group) for secondary outcomes. CONCLUSION Offering a 12-week yoga program to adults with chronic or recurrent low back pain led to greater improvements in back function than did usual care. PRIMARY FUNDING SOURCE Arthritis Research UK.

Can stand-alone computer-based interventions reduce alcohol consumption? A systematic review

AIM To determine the effects of computer-based interventions aimed at reducing alcohol consumption in adult populations. METHODS The review was undertaken following standard Cochrane and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance for systematic reviews. The literature was searched until December 2008, with no restrictions on language. Randomized trials with parallel comparator groups were identified in the form of published and unpublished data. Two authors independently screened abstracts and papers for inclusion. Data extraction and bias assessment was undertaken by one author and checked by a second author. Studies that measured total alcohol consumption and frequency of binge drinking episodes were eligible for inclusion in meta-analyses. A random-effects model was used to pool mean differences. RESULTS Twenty-four studies were included in the review (19 combined in meta-analyses). The meta-analyses suggested that computer-based interventions were more effective than minimally active comparator groups (e.g. assessment-only) at reducing alcohol consumed per week in student and non-student populations. However, most studies used the mean to summarize skewed data, which could be misleading in small samples. A sensitivity analysis of those studies that used suitable measures of central tendency found that there was no difference between intervention and minimally active comparator groups in alcohol consumed per week by students. Few studies investigated non-student populations or compared interventions with active comparator groups. CONCLUSION Computer-based interventions may reduce alcohol consumption compared with assessment-only; the conclusion remains tentative because of methodological weaknesses in the studies. Future research should consider that the distribution of alcohol consumption data is likely to be skewed and that appropriate measures of central tendency are reported.

Adequacy and reporting of allocation concealment: review of recent trials published in four general medical journals

In randomised controlled trials, allocation concealment (separating the process of randomisation from the recruitment of participants) is important for rigorously designed trials.1–4 In 1996 many major medical journals adopted the CONSORT statement (whereby researchers have to include a short checklist of essential items and a flow diagram when reporting trials),5 and this move encouraged the reporting of allocation concealment. We reviewed the prevalence of adequate allocation concealment and its association with the statistical significance of trial results. We searched by hand four general medical journals (the BMJ, JAMA , the Lancet , and the New England Journal of Medicine ) to identify randomised controlled trials published from January 2002 to December 2002. We included articles if the authors reported that participants were randomised and if the trial was published as a full report with the results of the main analyses. We categorised articles according to whether allocation concealment was adequate (the person who executed the allocation sequence was different from the person who recruited …

Surgical vs Nonsurgical Treatment of Adults With Displaced Fractures of the Proximal Humerus: The PROFHER Randomized Clinical Trial

IMPORTANCE The need for surgery for the majority of patients with displaced proximal humeral fractures is unclear, but its use is increasing. OBJECTIVE To evaluate the clinical effectiveness of surgical vs nonsurgical treatment for adults with displaced fractures of the proximal humerus involving the surgical neck. DESIGN, SETTING, AND PARTICIPANTS A pragmatic, multicenter, parallel-group, randomized clinical trial, the Proximal Fracture of the Humerus Evaluation by Randomization (PROFHER) trial, recruited 250 patients aged 16 years or older (mean age, 66 years [range, 24-92 years]; 192 [77%] were female; and 249 [99.6%] were white) who presented at the orthopedic departments of 32 acute UK National Health Service hospitals between September 2008 and April 2011 within 3 weeks after sustaining a displaced fracture of the proximal humerus involving the surgical neck. Patients were followed up for 2 years (up to April 2013) and 215 had complete follow-up data. The data for 231 patients (114 in surgical group and 117 in nonsurgical group) were included in the primary analysis. INTERVENTIONS Fracture fixation or humeral head replacement were performed by surgeons experienced in these techniques. Nonsurgical treatment was sling immobilization. Standardized outpatient and community-based rehabilitation was provided to both groups. MAIN OUTCOMES AND MEASURES Primary outcome was the Oxford Shoulder Score (range, 0-48; higher scores indicate better outcomes) assessed during a 2-year period, with assessment and data collection at 6, 12, and 24 months. Sample size was based on a minimal clinically important difference of 5 points for the Oxford Shoulder Score. Secondary outcomes were the Short-Form 12 (SF-12), complications, subsequent therapy, and mortality. RESULTS There was no significant mean treatment group difference in the Oxford Shoulder Score averaged over 2 years (39.07 points for the surgical group vs 38.32 points for the nonsurgical group; difference of 0.75 points [95% CI, -1.33 to 2.84 points]; P = .48) or at individual time points. There were also no significant between-group differences over 2 years in the mean SF-12 physical component score (surgical group: 1.77 points higher [95% CI, -0.84 to 4.39 points]; P = .18); the mean SF-12 mental component score (surgical group: 1.28 points lower [95% CI, -3.80 to 1.23 points]; P = .32); complications related to surgery or shoulder fracture (30 patients in surgical group vs 23 patients in nonsurgical group; P = .28), requiring secondary surgery to the shoulder (11 patients in both groups), and increased or new shoulder-related therapy (7 patients vs 4 patients, respectively; P = .58); and mortality (9 patients vs 5 patients; P = .27). Ten medical complications (2 cardiovascular events, 2 respiratory events, 2 gastrointestinal events, and 4 others) occurred in the surgical group during the postoperative hospital stay. CONCLUSIONS AND RELEVANCE Among patients with displaced proximal humeral fractures involving the surgical neck, there was no significant difference between surgical treatment compared with nonsurgical treatment in patient-reported clinical outcomes over 2 years following fracture occurrence. These results do not support the trend of increased surgery for patients with displaced fractures of the proximal humerus. TRIAL REGISTRATION isrctn.com Identifier: ISRCTN50850043.

Screening for postnatal depression in primary care: cost effectiveness analysis

Objective To evaluate the cost effectiveness of routine screening for postnatal depression in primary care. Design Cost effectiveness analysis with a decision model of alternative methods of screening for depression, including standardised postnatal depression and generic depression instruments. The performance of screening instruments was derived from a systematic review and bivariate meta-analysis at a range of instrument cut points; estimates of other relevant parameters were derived from literature sources and relevant databases. A decision tree considered the full treatment pathway from the possible onset of postnatal depression through identification, treatment, and possible relapse. Setting Primary care. Participants A hypothetical population of women assessed for postnatal depression either via routine care only or supplemented by use of formal identification methods six weeks postnatally, as recommended in recent guidelines. Main outcome measures Costs expressed in 2006-7 prices and impact on health outcomes expressed in terms of quality adjusted life years (QALYs). The time horizon of the analysis was one year. Results The routine application of either postnatal or general depression questionnaires did not seem to be cost effective compared with routine care only. The Edinburgh postnatal depression scale (at a cut point of 16) had an incremental cost effectiveness ratio (ICER) of £41 103 (€45 398,

Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial): large scale pragmatic randomised controlled trial.

67 130) per QALY compared with routine care only. The ICER for all other strategies ranged from £49 928 to £272 463 per QALY versus routine care only, while the probability that no formal identification strategy was cost effective was 88% (59%) at a cost effectiveness threshold of £20 000 (£30 000) per QALY. While sensitivity analysis indicated that the cost of managing incorrectly identified depression (false positive result) was an important driver of the model, formal identification approaches did not seem to be cost effective at any feasible estimate of this cost. Conclusions Formal identification methods for postnatal depression do not seem to represent value for money for the NHS. The major determinant of cost effectiveness seems to be the potential additional costs of managing women incorrectly diagnosed as depressed. Formal identification methods for postnatal depression do not currently satisfy the National Screening Committee’s criteria for the adoption of a screening strategy as part of national health policy.