Farming, Personal Protective Equipment, Nepal
Farming, Personal Protective Equipment, Nepal
According to the World Health Organization pesticide poisoning is a major health problem due
 to the millions of cases annually occurring worldwide. Farmers have a particularly high risk
 of pesticide poisoning because of their work involving pesticide use to protect crops. The
 majority of pesticide poisonings occur in developing countries. On a short term it is not
 realistic to reduce farmers' use of pesticides significantly because it would require that
 secure and cost-effective alternatives are introduced. This is a lengthy process, which
 should undoubtedly be supported. However, it becomes as important to make sure that farmers
 can protect themselves from pesticide exposure meanwhile. Use of personal protective
 equipment can minimize pesticide exposure on farmers' bodies and consequently reduce their
 risk of pesticide poisoning. However, the sparse research identified through a systematic
 literature review shows that we are not in a position to give recommendations on what
 personal protective equipment farmers should protect themselves with against pesticide
 exposure suitable to their specific conditions. The purpose of the present study is to
 examine factors that influence farmers' use of personal protective equipment during their
 work with organophosphates and, based on this examine the ability of locally adapted personal
 protective equipment to reduce their organophosphate exposure. The hypothesis is that farmers
 working in locally adapted personal protective equipment have less acute organophosphate
 poisoning symptoms, a higher plasma cholinesterase level and find it to be a more feasible
 solution than farmers working in their daily practice wearing. Examining how locally adapted
 personal protective equipment (onwards referred to as the LAPPE solution) performs in
 practice implies testing it in an intervention study. A randomized crossover experiment
 design is chosen partly because fewer farmers have to be recruited since each farmer will act
 as his own control and partly because the between farmer variation is strongly reduced. The
 performance of the LAPPE solution will be tested in one experiment and compared to the
 performance of the same farmers' daily practice wearing (onwards referred to as the DP
 solution) in another experiment. The LAPPE solution is expected to have a superior
 performance. The participation sequence (LAPPE/DP or DP/LAPPE) will be randomized. The study
 will be conducted among farmers in Chitwan, Nepal.
LITERATURE SEARCH STRATEGY:

 Based on recommendations from information specialists in the field of health, agriculture and
 technology the following databases were chosen to search for scientific literature about the
 present study's purpose: Pubmed, Embase, SveMed, CAB abstracts (Centre for Agriculture and
 Biosciences International), Agris, DADS (Denmark's Technical University's Digital Library),
 Scopus and Ebsco. The key search terms for the literature search were: personal protective
 equipment, farmers, pesticides, developing countries and tropical climate. Synonyms for each
 of these search terms were identified by means of Gyldendals Dictionary and previous
 international literature. In Pubmed, SveMed, Embase, CAB abstracts and Agris the synonyms
 were applied to find subject headings which the main search was based on. However, in DADS,
 Scopus, Ebsco searches on subject headings was not an option and therefore the main search
 was based on the synonyms.

 -  Pubmed: 3349 hits, subject headings for key terms personal protective equipment and
 pesticides with no limitations.

 -  Embase: 399 hits, subject headings for key terms personal protective equipment and
 pesticides with the limitation human.

 -  SveMed: 24 hits, subject headings for key terms personal protective equipment and
 pesticides.

 -  CAB abstracts: 607 hits, subject headings for key terms personal protective equipment
 and pesticides.

 -  Agris: 681 hits, subject headings for key terms personal protective equipment and
 pesticides.

 -  DADS 8650 hits, subject headings for key terms personal protective equipment and
 pesticides.

 -  Scopus: 1988 hits, synonyms for key terms personal protective equipment and pesticides
 and developing countries and tropical climate with the limitation to human.

 -  EBSCO: 722 hits, synonyms for key terms personal protective equipment and pesticides.

 Firstly, the relevance of titles was evaluated, secondly the relevance of abstracts from hits
 with relevant titles was evaluated and thirdly the relevance of full texts from hits with
 relevant abstracts was evaluated. A search was made based on the function 'related studies'
 for each relevant study in each database. The reference list of each relevant study was
 viewed and searched in Web of Science for citations. Finally each accessible relevant study
 was read carefully (5 hits). Exclusion criteria were studies on closed farming, mechanized
 farming, non-tropical conditions, and farming in industrialized countries or laboratory
 performance testing of personal protective equipment seeing that these criteria would not
 represent typical farming conditions in developing countries. Grey literature was searched in
 databases of the International Labor Organization, World Health Organization and Food and
 Agricultural Organization.

 STUDY AREA:

 Nepal is divided into 75 administrative districts. Pesticide consumption data show that
 excessive use of pesticides is common in different crops such as rice, maize, wheat and
 vegetables production areas. Chitwan District is selected purposively for three reasons:

 -  One of the highest vegetable growing districts of Nepal is Chitwan.

 -  An excessive pesticide use is documented in Chitwan.

 -  An unpublished study being the first of its kind in Nepal known to the research group
 documents the seriousness of the problem in Chitwan. A comparative cross-sectional study
 was conducted among 90 vegetable farmers using hand pressured backpack sprayers and 90
 blood donors. Fifty %, 15 % and 13 % of the pesticides used by the vegetable farmers
 could be categorized as moderately, highly and slightly hazardous, respectively,
 according to the World Health Organization Hazard Classification. Organophosphates were
 one of the most common pesticides used by the vegetable farmers; the moderately
 hazardous chlorpyrifos and imidacloprid as well as the highly hazardous dichlorvos. Poor
 working practices without adequate safety precautions were common among the vegetable
 farmers. The vegetable farmers reported a higher number of acute organophosphate
 poisoning symptoms and had lower levels of acetyl cholinesterase than blood donors.
 Chitwan has a total population of around 566,661 and was a largely uncultivated dense
 forest before the Nepali government started spraying with the insecticide
 dichlorodiphenyltrichloroethane for a Malaria Eradication Project in the 1950s.
 Immediately, Chitwan became a major farming region and services and infrastructure
 expanded across the area. Out of a total 46,894 hectare of arable land, 44,291 hectare
 is used for agricultural purpose (maize, rice, wheat, beans, lentils, mustard and
 vegetables). Agriculture is the primary source of income for 75 % of the population.
 Around 4000-5000 people of the working population is engaged in vegetable farming.
 Chitwan has 40 village district committees and the District Agricultural Office
 considers 10 of these as pocket areas in terms of vegetable farming based on their own
 observations, experiments, monitoring and personal communication with vegetable farmers.
 The ten pocket areas are Mangalpur, Jagatpur, Shukranagar, Chainpur, Bhandara,
 Gitanagar, Sibanagar, Jutpani, Kumroj and Padampur. To the extent that it is possible
 farmers fulfilling the inclusion and exclusion criteria of the present study in these
 pocket areas will be recruited:

 RECRUITMENT STRATEGY:

 Non-probability.

 SAMPLE SIZE DETERMINATION:

 The sample size calculations are based on a quasi-experimental unpublished study of 25
 vegetable farmers from Chitwan whose acute organophosphate poisoning symptoms and plasma
 cholinesterase levels were measured pre and post an organophosphate spraying session on the
 same day during daily practice conditions.

 -  Mean number of acute organophosphate poisoning symptoms 1.08±1.32 (Pre spraying
 measurement) 2.4±1.87 (Post spraying measurement) 0.0003 (P-value)

 -  Mean U/ml level of plasma cholinesterase 1.41±0.59 (Pre spraying measurement) 1.29±0.54
 (Post spraying measurement) 0.0548 (P-value)

 The pre and post organophosphate spraying measurements are considered to represent the
 "healthiest" and "unhealthiest" condition that the vegetable farmers can be expected to be
 in, respectively. Thus, for the present study the pre and post organophosphate spraying
 measurements are expected to resemble the results among the farmers after having worked with
 organophosphates wearing the LAPPE solution and DP solution, respectively. A sample size
 suitable to the study resources was gained when applying the pre and post results of the
 number of acute organophosphate poisoning symptoms.

 -  Paired means = 1.08, 2.4

 -  Paired standard deviations = 1.320,1.870

 -  Correlation = 0

 -  Sides = 1, 2

 -  Alpha = 0.05

 -  Power = 0.9

 Taking into consideration dropouts, technical problems leading to invalid measurements,
 refusals and co-variables for multivariate analyses 33 % of the sample size (34 pairs) is
 added, the result being rounded up to 50 pairs of farmers needed for the present study.

 DATA ANALYSES:

 Descriptive:

 -  Frequency, proportion categorical variables

 -  Mean, minimum, maximum and standard deviation of numeric variables

 -  Table crossing background, explanatory and feasibility variables with LAPPE/DP
 experiment

 -  Table crossing number of acute organophosphate poisoning symptoms with plasma
 cholinesterase levels U/ml

 Unadjusted (paired t-test and McNemar test):

 -  Mean difference in number of acute organophosphate poisoning symptoms after both
 experiments

 -  Mean difference in plasma cholinesterase level U/ml after both experiments

 Adjusted (mixed model):

 -  Number of acute organophosphate poisoning symptoms after the LAPPE experiment is
 compared to the number of acute organophosphate poisoning symptoms after the DP
 experiment adjusted for baseline values, period effect, experiment sequence and
 explanatory variables.

 -  Plasma cholinesterase level U/ml after the LAPPE experiment is compared to the plasma
 cholinesterase level U/ml after the DP experiment adjusted for baseline values, period
 effect, experiment sequence and explanatory variables.

 Sensitivity:

 To allow confidence in the main finding its robustness will be assessed by repeating the
 analyses with more rigid health outcome definitions if possible such as:

 -  Farmers with acute organophosphate poisoning symptoms before the LAPPE and DP experiment
 are excluded.

 -  Farmers with more abnormal plasma cholinesterase levels U/ml before the LAPPE and DP
 experiment are excluded.

 -  Farmers with chronic illness are excluded.

 -  Farmers who respond to the "fake" symptoms are excluded.

 ETHICAL CONSIDERATIONS:

 Informal recognition and encouragement in Chitwan will be obtained from the District
 Agricultural Office and District Public Health Office. An advisory opinion from the Danish
 Ethics Committee will be obtained. Informed consents will be retrieved from farmers
 participating in the pre-testing and experiments.

 The plasma cholinesterase measurement will make it possible to identify farmers with abnormal
 levels. If such cases occur the farmer will be excluded from the study and given advice on
 how to proceed. The small amount of blood required is not considered as damaging to the
 farmers' health. However, the finger stick may have minor risks such as momentary pain when
 the lancet goes into the finger, bruise, visible and sore puncture site for a short period,
 feeling of dizziness or light headedness. Disposable finger stick lancets will be used to
 avoid any infectious transmission.

 The LAPPE solution will be provided to the farmers after their participation with an
 information folder and oral explanation on how to store the LAPPE. Despite the results of the
 study, the LAPPE solution is an improvement in farmers' current practice which is that they
 basically do not protect themselves according to the recommendations of World Health
 Organization or Food and Agricultural Organization.

 The choice of organophosphates for the experiments will be based on the type of
 organophosphates that the farmers already use. In other words, the farmers will not be
 exposed to less or more dangerous pesticides than what they usually expose themselves to.
 During the data collection the organophosphates will be stored according to their safety
 label recommendations. In case, the remaining organophosphates cannot be used in other
 studies they will be disposed by taking safety precautions as recommended by the World Health
 Organization.

 During all study activities a first aid kit will be accessible and the data collectors will
 wear basic personal protective equipment during the experiments and informed about a safe
 handling of organophosphates.

 During data entry, data is stored on two external hard disks and the principal investigator's
 computer in the control of the principal investigator. Data on the Test Mate ChE
 Cholinesterase System is automatically deleted when the power is switched off. Every week a
 full backup of the data file will be saved on a USB stick placed outside research
 establishments under the principal investigator's control until the data entry is complete.
 Data editing and analysis will be based on a data file without sensitive information (like
 name, address and phone number). The data file will be saved on an external hard disk, USB
 stick and the principal investigator's computer drop box on a daily basis and kept under
 secure conditions and with only access to the principal investigator.

 The following data will be stored in a locked safe under research establishments in the sole
 control of the principal investigator:

 -  Original data

 -  File with raw data

 -  File with analyzable and anonymized data

 -  File linking farmers' sensitive information with their study identification number

 The following data will be stored in a locked safe outside research establishments in the
 sole control of the principal investigator and safe owners:

 • File with analyzable data excluding sensitive information

 If necessary, during analysis and interpretation of results the research group can get access
 to the file with analyzable and anonymized data through e-mail. However, the e-mail will not
 contain the file linking sensitive information with study identification numbers and is
 therefore considered as being manually encrypted.

 Upon completion of the research study the original data will be cut into pieces, placed in a
 sealable bag which can be tightly tied, fill the bag with water and then transfer the bag to
 a waste container. Blood tests and materials used in this regard will be given to Nepal Red
 Cross Society. Data stored outside research establishments will be retrieved. Two independent
 data files; one file with analyzable data excluding sensitive information and another file
 with farmers' sensitive information linking to their study identification number and scanned
 copies of informed consents will be stored in Nepal for up to five years. Potential
 permission to store data in Denmark will be seeked from the Danish Data Protection Agency.
 Upon approval data will be sent to the Danish Data Archive for indefinite storage time with
 data documentation. The condition for data access to the Danish Data Archive is that only the
 principal investigator will have access to the data and full control of giving permission for
 sharing data with others in the future. If sharing of data occurs the new researcher will
 have to seek approval from the Danish Data Protection Agency and then consult the Danish Data
 Archive.
Inclusion

 -  Male (females usually wear national dresses considered to provide adequate protection
 (43).

 -  Age min. 18 years (implies being a legal worker).

 -  Grows crops in knee and abdomen height in given data collection period.

 -  Willing to spend 1.5-3 hours working with organophosphates under normal working
 conditions.

 -  Involved in farming minimum two years (implies being active).

 -  Usually sprays at least once in two weeks with organophosphates on average (implies
 being active).

 -  Uses a hand pressured backpack sprayer placed at home (necessary to complete
 non-intervention).

 -  Works with crops in 5-10 katha land (sufficient to apply organophosphates for given
 time).

 -  Has a mobile/landline number (necessary for easy contact).

 Exclusion

 -  Has a helper during work with organophosphates (organophosphate exposure reduced).

 -  Is unwilling to stay organophosphate free one week prior to each of two experiment
 days (necessary for comparable measurements).

 -  Has any of the following conditions: liver disease/damage, alcoholic/viral hepatitis,
 acute infection, chronic malnutrition, heart attack, metastasis, obstructive jaundice,
 inflammation, uses pyridostigmine drugs (decreases or increases plasma cholinesterase)
 (44-46).