Towards core outcome set (COS) development: a follow-up descriptive survey of outcomes in Cochrane reviews

BACKGROUND: A core outcome set (COS) can address problems of outcome heterogeneity and outcome reporting bias in trials and systematic reviews, including Cochrane reviews, helping to reduce waste. One of the aims of the international Core Outcome Measures in Effectiveness Trials (COMET) Initiative is to link the development and use of COS with the outcomes specified and reported in Cochrane reviews, including the outcomes listed in the summary of findings (SoF) tables. As part of this work, an earlier exploratory survey of the outcomes of newly published 2007 and 2011 Cochrane reviews was performed. This survey examined the use of COS, the variety of specified outcomes, and outcome reporting in Cochrane reviews by Cochrane Review Group (CRG). To examine changes over time and to explore outcomes that were repeatedly specified over time in Cochrane reviews by CRG, we conducted a follow-up survey of outcomes in 2013 Cochrane reviews.

METHODS: A descriptive survey of outcomes in Cochrane reviews that were first published in 2013. Outcomes specified in the methods sections and reported in the results section of the Cochrane reviews were examined by CRG. We also explored the uptake of SoF tables, the number of outcomes included in these, and the quality of the evidence for the outcomes.

RESULTS: Across the 50 CRGs, 375 Cochrane reviews that included at least one study specified a total of 3142 outcomes. Of these outcomes, 32 % (1008) were not reported in the results section of these reviews. For 23 % (233) of these non-reported outcomes, we did not find any reason in the text of the review for this non-report. Fifty-seven percent (216/375) of reviews included a SoF table.

CONCLUSIONS: The proportion of specified outcomes that were reported in Cochrane reviews had increased in 2013 (68 %) compared to 2007 (61 %) and 2011 (65 %). Importantly, 2013 Cochrane reviews that did not report specified outcomes were twice as likely to provide an explanation for why the outcome was not reported. There has been an increased uptake of SoF tables in Cochrane reviews. Outcomes that were repeatedly specified in Cochrane reviews by CRG in 2007, 2011, and 2013 may assist COS development.

What’s behind Russia’s military build-up in Syria?

It seems unlikely that Moscow can hope for an outright victory in Syria’s civil war, so some kind of political compromise with the moderate opposition is in the offing. This, however, is at best a long shot given the hostility to Assad in the West and the intensity of the conflict in Syria.

Instead, the immediate priority seems to be to ensure a survival of the Syrian state and military institutions in the areas it can control, what one Russian observer called an “Alawite Israel” – a strip of land from the Mediterranean coast to Damascus, able to at least contain IS with some external support.

The Kremlin has consistently prioritised stability over revolutionary change and sovereign rights over humanitarian intervention. In fact, from the Russian point of view, the Western interventionist agenda of democratisation, which ignored local conditions, has made the situation in the Middle East worse – from Iraq to Libya and Syria.

Participating in a fruit and vegetable intervention trial improves longer term fruit and vegetable consumption and barriers to fruit and vegetable consumption: a follow-up of the ADIT study

BACKGROUND: Fruit and vegetable (FV) based intervention studies can be effective in increasing short term FV consumption. However, the longer term efficacy of such interventions is still unclear. The aim of the current study was to examine the maintenance of change in FV consumption 18-months after cessation of a FV intervention and to examine the effect of participating in a FV intervention on barriers to FV consumption.

METHODS: A follow-up of a randomised controlled FV trial in 83 older adults (habitually consuming ≤2 portions/day) was conducted. At baseline, participants were assigned to continue consuming ≤2 portions FV/day or consume ≥5 portions FV/day for 16-weeks. We assessed FV intake and barriers to FV consumption at baseline, end of intervention and 18-months post-intervention.

RESULTS: At 18-months, mean FV intakes in both groups were greater than baseline. The 5 portions/day group continued to show greater increases in FV consumption at 18-months than the 2 portions/day group (p < 0.01). At 18-months, both groups reported greater liking (p < 0.01) and ease in consuming FV (p = 0.001) while difficulties with consuming FV decreased (p < 0.001). The 2 portions/day group reported greater awareness of FV recommendations at 18-months (p < 0.001).

CONCLUSIONS: Participating in a FV intervention can lead to longer-term positive changes in FV consumption regardless of original group allocation.

TRIAL REGISTRATION: Clinical Trials.gov NCT00858728 .

Scaling Up Market Anomalies

This paper implements momentum among a host of market anomalies. Our investment universe consists of the 15 top (long-leg) and 15 bottom (short-leg) anomaly portfolios. The proposed active strategy buys (sells short) a subset of the top (bottom) anomaly portfolios based on past one-month return. The evidence shows statistically strong and economically meaningful persistence in anomaly payoffs. Our strategy consistently outperforms a naive benchmark that equal weights anomalies and yields an abnormal monthly return ranging between 1.27% and 1.47%. The persistence is robust to the post-2000 period, and various other considerations, and is stronger following episodes of high investor sentiment.

Six-year follow-up of the SPHERE RCT: secondary prevention of heart disease in general practice.

Objective: To determine the long-term effectiveness of a complex intervention in primary care aimed at improving outcomes for patients with coronary heart disease.

Design: A 6-year follow-up of a cluster randomised controlled trial, which found after 18 months that both total and cardiovascular hospital admissions were significantly reduced in intervention practices (8% absolute reduction).

Setting: 48 general practices in the Republic of Ireland and Northern Ireland.

Participants: 903 patients with established coronary heart disease at baseline in the original trial.

Intervention: The original intervention consisted of tailored practice and patient plans; training sessions for practitioners in medication prescribing and behavioural change; and regular patient recall system. Control practices provided usual care. Following the intervention period, all supports from the research team to intervention practices ceased.

Outcome measures: Primary outcome: hospital admissions, all cause and cardiovascular; secondary outcomes: mortality; blood pressure and cholesterol control.

Results: At 6-year follow-up, data were collected from practice records of 696 patients (77%). For those who had died, we censored their data at the point of death and cause of death was established. There were no significant differences between the intervention and control practices in either total (OR 0.83 (95% CI 0.54 to 1.28)) or cardiovascular hospital admissions (OR 0.91 (95% CI 0.49 to 1.65)). We confirmed mortality status of 886 of the original 903 patients (98%). There were no significant differences in mortality (15% in intervention and 16% in control) or in the proportions of patients above target control for systolic blood pressure or total cholesterol.

Conclusions: Initial significant differences in the numbers of total and cardiovascular hospital admissions were not maintained at 6 years and no differences were found in mortality or blood pressure and cholesterol control. Policymakers need to continue to assess the effectiveness of previously efficacious programmes.

Trial registration number: Current Controlled Trials ISRCTN24081411.

Assessment of cataract surgical outcomes in settings where follow-up is poor:PRECOG, a multicentre observational study

Background: Poor follow-up after cataract surgery in developing countries makes assessment of operative quality uncertain. We aimed to assess two strategies to measure visual outcome: recording the visual acuity of all patients 3 or fewer days postoperatively (early postoperative assessment), and recording that of only those patients who returned for the final follow-up examination after 40 or more days without additional prompting. Methods: Each of 40 centres in ten countries in Asia, Africa, and Latin America recruited 40-120 consecutive surgical cataract patients. Operative-eye best-corrected visual acuity and uncorrected visual acuity were recorded before surgery, 3 or fewer days postoperatively, and 40 or more days postoperatively. Clinics logged whether each patient had returned for the final follow-up examination without additional prompting, had to be actively encouraged to return, or had to be examined at home. Visual outcome for each centre was defined as the proportion of patients with uncorrected visual acuity of 6/18 or better minus the proportion with uncorrected visual acuity of 6/60 or worse, and was calculated for each participating hospital with results from the early assessment of all patients and the late assessment of only those returning unprompted, with results from the final follow-up assessment for all patients used as the standard. Findings: Of 3708 participants, 3441 (93%) had final follow-up vision data recorded 40 or more days after surgery, 1831 of whom (51% of the 3581 total participants for whom mode of follow-up was recorded) had returned to the clinic without additional prompting. Visual outcome by hospital from early postoperative and final follow-up assessment for all patients were highly correlated (Spearman's r_s=0·74, p<0·0001). Visual outcome from final follow-up assessment for all patients and for only those who returned without additional prompting were also highly correlated (r_s=0·86, p<0·0001), even for the 17 hospitals with unprompted return rates of less than 50% (r_s=0·71, p=0·002). When we divided hospitals into top 25%, middle 50%, and bottom 25% by visual outcome, classification based on final follow-up assessment for all patients was the same as that based on early postoperative assessment for 27 (68%) of 40 centres, and the same as that based on data from patients who returned without additional prompting in 31 (84%) of 37 centres. Use of glasses to optimise vision at the time of the early and late examinations did not further improve the correlations. Interpretation: Early vision assessment for all patients and follow-up assessment only for patients who return to the clinic without prompting are valid measures of operative quality in settings where follow-up is poor. Funding: ORBIS International, Fred Hollows Foundation, Helen Keller International, International Association for the Prevention of Blindness Latin American Office, Aravind Eye Care System. © 2013 Congdon et al. Open Access article distributed under the terms of CC BY.

Determinants of pediatric cataract program outcomes and follow-up in a large series in Mexico.

PURPOSE:

To report determinants of outcomes and follow-up in a large Mexican pediatric cataract project.

SETTING:

Hospital Luis Sanchez Bulnes, Mexico City, Mexico.

METHODS:

Data were collected prospectively from a pediatric cataract surgery program at the Hospital Luis Sanchez Bulnes, implemented by Helen Keller International. Preoperative data included age, sex, baseline visual acuity, type of cataract, laterality, and presence of conditions such as amblyopia. Surgical data included vitrectomy, capsulotomy, complications, and use of intraocular lenses (IOLs). Postoperative data included final visual acuity, refraction, number of follow-up visits, and program support for follow-up.

RESULTS:

Of 574 eyes of 415 children (mean age 7.1 years +/- 4.7 [SD]), IOLs were placed in 416 (87%). At least 1 follow-up was attended by 408 patients (98.3%) (mean total follow-up 3.5 +/- 1.8 months); 40% of eyes achieved a final visual acuity of 6/18 or better. Children living farther from the hospital had fewer postoperative visits (P = .04), while children receiving program support had more visits (P = .001). Factors predictive of better acuity included receiving an IOL during surgery (P = .04) and provision of postoperative spectacles (P = .001). Predictive of worse acuity were amblyopia (P = .003), postoperative complications (P = .0001), unilateral surgery (P = .0075), and female sex (P = .045).

CONCLUSIONS:

The results underscore the importance of surgical training in reducing complications, early intervention before amblyopia (observed in 40% of patients) can develop, and vigorous treatment if amblyopia is present. The positive impact of program support on follow-up is encouraging, although direct financial support may pose a problem for sustainability. More work is needed to understand reasons for worse outcomes in girls.

Visual outcomes and astigmatism after sutureless, manual cataract extraction in rural China: study of cataract outcomes and up-take of services (SCOUTS) in the caring is hip project, report 1.

OBJECTIVE: To study the visual acuity and astigmatism of persons undergoing cataract extraction by local surgeons in rural China. METHODS: Visual acuity, keratometry, and refraction were measured 10 to 14 months postoperatively for all cataract cases during 4 months in Sanrao, China. RESULTS: Among 313 eligible subjects, 242 (77%) could be contacted, of whom 176 (73%) were examined. Of those who were examined, mean +/- SD age was 69.3 +/- 10.5 years, 66.5% were female, 35 had been operated on bilaterally at Sanrao, and 85.2% had a preoperative presenting visual acuity of 6/60 or worse. Presenting and best-corrected postoperative acuity in the eye that was operated on were 6/18 or better in 83.4% and 95.7%, respectively. Among 27 fellow eyes operated on elsewhere, 40.7% had a presenting acuity of 6/18 or better and 40.7% were blind (P < .001). Mean +/- SD postoperative astigmatism did not differ between 211 eyes that were operated on (-1.13 +/- 0.84 diopters) and 109 eyes that were not (-1.13 +/- 1.17 diopters; P = .27). Presence of operative complications (8.5%) and older age were associated with worse vision; bilateral surgery was associated with better vision. CONCLUSIONS: These results confirm the effectiveness of skill transfer in this setting, with superior outcomes to most studies in rural Asia and to eyes in this cohort operated on at other facilities.

Visual function and postoperative care after cataract surgery in rural China: study of cataract outcomes and up-take of services (SCOUTS) in the caring is hip project, report 2.

OBJECTIVE:

To study the postoperative visual function and uptake of refraction and second-eye surgery among persons undergoing cataract surgery in rural China.

METHODS:

Self-reported visual function was measured 10 to 14 months after surgery. Subjects with improvement of 2 or more lines with refraction were offered glasses, and those with significant cataract were offered second-eye surgery.

RESULTS:

Among 313 eligible subjects, 242 (77%) could be contacted; 176 (73%) of those contacted were examined. Interviewed subjects had a mean +/- SD age of 69.9 +/- 10.2 years, and 63.6% were female. The mean +/- SD visual function score was 88.4 +/- 12.3, higher than previously reported for cataract programs in rural China and significantly (P = .03) correlated with presenting vision. Forty-two percent of subjects had spectacles, more than half being reading glasses. Though 87% of subjects' vision improved with refraction, only 35% accepted prescriptions, the most common reason for refusal being lack of perceived need. Second-eye surgery was accepted by a total of 48% (85 of 176) of patients, cost being the biggest reason for refusal.

CONCLUSIONS:

Visual function was high in this cohort. Potential benefit of refraction and second-eye surgery was substantial, but uptake of services was modest. Programs to improve service uptake should focus on reading glasses and cost-reduction strategies such as tiered pricing.

Distribution and visual impact of postoperative refractive error after cataract surgery in rural China: study of cataract outcomes and up-take of services report 4.

PURPOSE: To model the possible impact of using average-power intraocular lenses (IOLs) and evaluate the postoperative refractive error in patients having cataract surgery in rural China.SETTING: Rural Guangdong, China.METHODS: Patients having cataract surgery by local surgeons were examined and visual function was assessed 10 to 14 months after surgery. Subjective refraction at near and distance was performed bilaterally by an ophthalmologist. Patients had a target refraction of -0.50 diopter (D) based on ocular biometry.RESULTS: Of the 313 eligible patients, 242 (77%) could be contacted and 176 (74% of contacted patients, 56% overall) were examined. Examined patients had a mean age of 69.4 +/- 10.5 years. Of the 211 operated eyes, 73.2% were within +/-1.0 D of the target refraction after surgery. The best presenting distance vision was in patients within +/-1.0 D of plano and the best presenting near vision, in those with mild myopia (<-1.0 D to > or =2.0 D) (P= .005). However, patients with hyperopia (>+1.0 D) reported significantly better adjusted visual function than those with emmetropia or myopia (<-1.0 D). When the predicted use of an average-power IOL (median +21.5 D) was modeled, predicted visual acuity was significantly reduced (P= .001); however, predicted visual function was not significantly altered (P>.3).CONCLUSIONS: Accurate selection of postoperative refractive error was achieved by local surgeons in this rural area. Based on visual function results, aiming for mild postoperative myopia may not be suitable in this setting. Implanting average-power IOLs significantly reduced postoperative presenting vision, but not visual function.

Sources of patient knowledge and financing of cataract surgery in rural China: the Sanrao Study of Cataract Outcomes and Up-Take of Services (SCOUTS), report 6.

AIM: To study patient sources of knowledge about cataract surgical services, and strategies for financing surgery in rural China. DESIGN: Cross-sectional case series. METHODS: Patients undergoing cataract surgery by local surgeons in a government, village-level facility in Sanrao, Guangdong between 8 August and 31 December 2005 were examined and had standardised interviews an average of 12 months after surgery. RESULTS: Of 313 eligible patients, 239 (76%) completed the questionnaire. Subjects had a mean (SD) age of 69.9 (10.2) years, 36.4% (87/239) were male, and 87.0% (208/239) had been blind (presenting visual acuity < or = 6/60) before surgery. Word-of-mouth advertising was particularly important: 198 (85.0%) of the subjects knew a person who had undergone cataract surgery, of whom 191 (96.5%) had had cataract surgery at Sanrao itself. Over 70% of subjects (166/239) watched TV daily, whereas 80.0% (188/239) "never" read the newspaper. Nearly two-thirds of suggestions from participants (n = 211, 59.6%) favoured either TV advertisements or word-of-mouth to publicise the programme. While the son or daughter had paid for surgery in over 70% of cases (164/233), the patient's having paid without help was the sole predictor of undergoing second-eye surgery (OR 2.27 (95% CI 1.01 to 5.0, p = 0.04)). DISCUSSION: Strategies to increase uptake of cataract surgery in rural China may benefit from enhancing word-of-mouth advertising (such as with pseudophakic motivators), using television advertising where affordable, and micro-credit or other programmes to enable patients to pay their own fees, thus increasing uptake of second-eye surgery.