198/200; Main text 4099/4000. Refs 85; Tables 1; Figures 1; Appendices 7. 2 CHESS PROMs review Cephalgia FTC:110117 Re-submit 240517 Tables edited 270717 Structured Abstract: (198/200) Aims To critically appraise, compare and synthesise the quality and acceptability of multi-item PROMs for adults with chronic or episodic headache. Methods Systematic literature searches of major databases (1980-2016) to identify published evidence of PROM measurement and practical properties. Data on study quality (COSMIN), measurement and practical properties per measure was extracted and assessed against accepted standards to inform an evidence synthesis. Results From 10,903 reviewed abstracts, 103 articles were assessed in full; 46 provided evidence for 23 PROMs: eleven specific to the health-related impact of migraine (n=5) or headache (n=6); six assessed migraine-specific treatment response/satisfaction; six were generic measures. Evidence for measurement validity and score interpretation was strongest for two measures of impact-Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) and Headache Impact Test 6-item (HIT-6), and one of treatment response-the Patient Perception of Migraine Questionnaire (PPMQ-R). Evidence of reliability was limited, but acceptable for the HIT-6. Responsiveness was rarely evaluated. Evidence for the remaining measures was limited. Patient involvement was limited and poorly reported. Conclusion Whilst evidence is limited, three measures have acceptable evidence of reliability and validity-HIT-6, MSQ v2.1 and PPMQ-R. Only the HIT-6 has acceptable evidence supporting its completion by all 'headache' populations.

BackgroundEffective task-shifting interventions targeted at reducing the global cardiovascular disease (CVD) epidemic in low and middle-income countries (LMICs) are urgently needed.MethodsDISHA is a cluster randomised controlled trial conducted across 10 sites (5 in phase 1 and 5 in phase 2) in India in 120 clusters. At each site, 12 clusters were randomly selected from a district. A cluster is defined as a small village with 250–300 households and well defined geographical boundaries. They were then randomly allocated to intervention and control clusters in a 1:1 allocation sequence. If any of the intervention and control clusters were <10 km apart, one was dropped and replaced with another randomly selected cluster from the same district. The study included a representative baseline cross-sectional survey, development of a structured intervention model, delivery of intervention for a minimum period of 18 months by trained frontline health workers (mainly Anganwadi workers and ASHA workers) and a post intervention survey in a representative sample. The study staff had no information on intervention allocation until the completion of the baseline survey. In order to ensure comparability of data across sites, the DISHA study follows a common protocol and manual of operation with standardized measurement techniques.DiscussionOur study is the largest community based cluster randomised trial in low and middle-income country settings designed to test the effectiveness of ‘task shifting’ interventions involving frontline health workers for cardiovascular risk reduction.Trial registrationCTRI/2013/10/004049. Registered 7 October 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/s12889-016-2891-6) contains supplementary material, which is available to authorized users.

Background Population‐wide reduction in mean blood pressure is proposed as a key strategy for primary prevention of cardiovascular disease. We evaluated the effectiveness of a task‐sharing strategy involving frontline health workers in the primary prevention of elevated blood pressure. Methods and Results We conducted DISHA (Diet and lifestyle Interventions for Hypertension Risk reduction through Anganwadi Workers and Accredited Social Health Activists) study, a cluster randomized controlled trial involving 12 villages each from 4 states in India. Frontline health workers delivered a custom‐made and structured lifestyle modification intervention in the selected villages. A baseline survey was conducted in 23 and 24 clusters in the control (n=6663) and intervention (n=7150) groups, respectively. The baseline characteristics were similar between control and intervention clusters. In total 5616 participants from 23 clusters in the control area and 5699 participants from 24 clusters in the intervention area participated in a repeat cross‐sectional survey conducted immediately after the intervention phase of 18‐months. The mean (SD) systolic blood pressure increased from 125.7 (18.1) mm Hg to 126.1 (16.8) mm Hg in the control clusters, and it increased from 124.4 (17.8) mm Hg to 126.7 (17.5) mm Hg in the intervention clusters. The population average adjusted mean difference in difference in systolic blood pressure was 1.75 mm Hg (95% CI, −0.21 to 3.70). Conclusions Task‐sharing interventions involving minimally trained nonphysician health workers are not effective in reducing population average blood pressure in India. Expanding the scope of task sharing and intensive training of health workers such as nurses, nutritionists, or health counselors in management of cardiovascular risk at the population level may be more effective in primary prevention of cardiovascular disease. Registration URL: https://www.ctri.nic.in ; Unique identifier: CTRI/2013/10/004049.