A minimum data set-Core outcome set, core data elements, and core measurement set-For degenerative cervical myelopathy research (AO Spine RECODE DCM): A consensus study.

BACKGROUND: Degenerative cervical myelopathy (DCM) is a progressive chronic spinal cord injury estimated to affect 1 in 50 adults. Without standardised guidance, clinical research studies have selected outcomes at their discretion, often underrepresenting the disease and limiting comparability between studies. Utilising a standard minimum data set formed via multi-stakeholder consensus can address these issues. This combines processes to define a core outcome set (COS)-a list of key outcomes-and core data elements (CDEs), a list of key sampling characteristics required to interpret the outcomes. Further "how" these outcomes should be measured and/or reported is then defined in a core measurement set (CMS). This can include a recommendation of a standardised time point at which outcome data should be reported. This study defines a COS, CDE, and CMS for DCM research. METHODS AND FINDINGS: A minimum data set was developed using a series of modified Delphi processes. Phase 1 involved the setup of an international DCM stakeholder group. Phase 2 involved the development of a longlist of outcomes, data elements, and formation into domains. Phase 3 prioritised the outcomes and CDEs using a two-stage Delphi process. Phase 4 determined the final DCM minimal data set using a consensus meeting. Using the COS, Phase 5 finalised definitions of the measurement construct for each outcome. In Phase 6, a systematic review of the literature was performed, to scope and define the psychometric properties of measurement tools. Phase 7 used a modified Delphi process to inform the short-listing of candidate measurement tools. The final measurement set was then formed through a consensus meeting (Phase 8). To support implementation, the data set was then integrated into template clinical research forms (CRFs) for use in future clinical trials (Phase 9). In total, 28 outcomes and 6 domains (Pain, Neurological Function, Life Impact, Radiology, Economic Impact, and Adverse Events) were entered into the final COS. Thirty two outcomes and 4 domains (Individual, Disease, Investigation, and Intervention) were entered into the final CDE. Finally, 4 outcome instruments (mJOA, NDI, SF-36v2, and SAVES2) were identified for the CMS, with a recommendation for trials evaluating outcomes after surgery, to include baseline measurement and at 6 months from surgery. CONCLUSIONS: The AO Spine RECODE-DCM has produced a minimum data set for use in DCM clinical trials today. These are available at https://myelopathy.org/minimum-dataset/. While it is anticipated the CDE and COS have strong and durable relevance, it is acknowledged that new measurement tools, alongside an increasing transition to study patients not undergoing surgery, may necessitate updates and adaptation, particularly with respect to the CMS.

Family Planning During and After the West African Ebola Crisis.

The West African Ebola outbreak of 2013-2016 had the potential to devastate family planning programs in affected countries, which had made great progress in years prior. We examine monthly provision of family planning service statistics from government sources for Liberia and Sierra Leone from 6 months before the first Ebola case to 24 months after the last Ebola case to measure the impact during and after the epidemic. By calculating the couple-years of protection from service statistics, we find that family planning distribution declined by 65 percent in Liberia and 23 percent in Sierra Leone at the peak of the epidemic. Two years after Ebola, Liberia's average monthly contraception distribution is 39 percent above precrisis levels, while distribution in Sierra Leone increased by 27 percent, findings echoed in data from the Demographic and Health Survey and Multiple Indicator Cluster Survey. Increased contraceptive use comes from implants in both countries, and injectables in Liberia. This study indicates that the family planning sector can recover, and continue to improve, following a significant disruption and is a lesson in resilience.

Transportation of peripheral blood progenitor cell products: effect of ambient temperature.

BACKGROUND AIMS: Peripheral blood progenitor cell (PBPC) products are often transported at high cell concentrations (>200 × 109/L) over long distances, requiring >36 h transport time. METHODS: Fresh PBPC samples from eight healthy donors were studied with two viability assays for effects of temperature outside the transport container (ambient temperature). The Coleman 5272 container, routinely used by the National Marrow Donor Program (NMDP) with two -20°C gel packs, was compared with the Coleman 6216 container, which can hold four -20°C gel packs. RESULTS: The temperature inside the smaller transport container (5272) proved to be sensitive to ambient temperature, whereas the larger container (6216) was less sensitive. The viability of CD34(+) cells, and the survival of granulocyte-macrophage colony-forming units (GM-CFU), was more dependent on the ambient temperature for the smaller than for the larger container. CONCLUSIONS: PBPC products are most often transported at approximately 2-8°C. The inside temperature of the container currently used by the NMDP appears to be more sensitive to increases in temperature when exposed to higher ambient temperature for prolonged periods of time. Increasing the number of gel packs from two to four improves the stability of the temperature inside the container but would require a different container.

Transportation of peripheral blood progenitor cell products: effects of time, temperature and cell concentration.

BACKGROUND AIMS: Peripheral blood progenitor cell (PBPC) products are often transported at high cell concentrations (>200x10(9)/L) over long distances, requiring >36 h transport time. METHODS: Fresh PBPC samples from 12 healthy donors were studied with various viability assays regarding the effects of temperature, cell concentration and duration of storage. RESULTS: Trypan blue exclusion was far less sensitive to cell damage than two-color fluorescence for CD34 and 7-AAD, and colony-forming unit-granulocyte-macrophage (CFU-GM) assays; the latter assay proved the most sensitive. All products stored at 4 degrees C maintained their viability for up to 4 days. Thus, at 96 h, recovery of viable CD34(+) cells was still 82%, and of CFU-GM 57%, even at concentrations of 200x10(9)/L. Higher storage temperatures rapidly decreased the viability, with extensive variation between donors. At room temperature 80% of viable CD34(+) cells and >90% of CFU-GM were lost after 48 h of storage at 200x10(9)/L. Lower cell concentrations allowed storage at higher temperatures: at 17 degrees C a concentration of 50x10(9)/L resulted in only 5% loss of viable CD34(+) cells after 48 h, while the loss was >30% at 200x10(9)/L. CONCLUSIONS: PBPC products should be transported at 4 degrees C. Dilution of the product may partly compensate for slightly higher temperatures. Trypan blue exclusion should be abandoned as a method for assessing viability after prolonged transportation. Proliferative assays should be used to validate transportation conditions.

Greater risks, fewer rights: U.S. farmworkers and pesticides.

Pesticide Action Network, United Farmworkers of America, and California Rural Legal Assistance Foundation analyzed California government data on agricultural poisonings and enforcement of worker safety standards. Nearly 500 pesticide poisonings were reported for California farmworkers every year from 1997 to 2000. The actual number of pesticide-related illnesses is unknown, since many poisonings go unreported. Most poisonings occurred as a result of soil fumigation and pesticide applications to grapes, oranges, and cotton. Pesticide drift accounted for 51% of the cases, and another 25% resulted from exposures to pesticide residues. Violations of worker safety laws were common, contributing to 41% of reported poisonings. No violations occurred in another 38%, indicating that existing laws inadequately protect workers from pesticide exposure. This snapshot of human rights abuse through pesticide exposure in California-the site of some of the world's most stringent pesticide use and worker safety laws-illustrates the global problem of pesticide poisoning among agricultural workers.