Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs).

BACKGROUND: Evidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to test trial processes or explore methodological uncertainties. SWAT evidence relies on replication to ensure sufficient power and broad applicability of findings. Prompt reporting is therefore essential; however, SWAT publications are often the first to be abandoned in the face of other time pressures. Reporting guidance for embedded methodology trials does exist but is not widely used. We sought therefore to build on these guidelines to develop a straightforward, concise reporting standard, which remains adherent to the CONSORT guideline. METHODS: An iterative process was used to develop the guideline. This included initial meetings with key stakeholders, development of an initial guideline, pilot testing of draft guidelines, further iteration and pilot testing, and finalisation of the guideline. RESULTS: We developed a reporting guideline applicable to randomised SWATs, including replications of previous evaluations. The guideline follows the Consolidated Standards for Reporting Trials (CONSORT) statement and provides example text to ensure ease and clarity of reporting across all domains. CONCLUSIONS: The SWAT reporting guideline will aid authors, reviewers, and journal editors to produce and review clear, structured reports of randomised SWATs, whilst also adhering to the CONSORT guideline. TRIAL REGISTRATION: EQUATOR Network - Guidelines Under Development ( https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#SWAT ). Registered on 25 March 2021.

Dietary polyunsaturated fatty acid effects on immune cells of the porcine lung.

The effects of various dietary polyunsaturated fatty acids (PUFAs) on the function of immune cells of the porcine lung was studied. Groups of six pigs were fed diets containing 10.5% corn oil [CO; enriched in linoleic acid (18:2, n-6)], linseed oil (LO; enriched in alpha-linolenic acid (18:3, n-3)], menhaden oil (MO; enriched in eicosapentaenoic (20:5; n-3) and docosahexaenoic (22:6; n-3) acids], linseed + corn oil (1:1; LC), and menhaden + corn oil (1:1; MC) for 28-30 days. Basal levels of alveolar macrophage (m phi) tumor necrosis factor-alpha (TNF-alpha) production were higher (P < .05) for LC- and MC-fed pigs than for CO- and LO-fed pigs. Lipopolysaccharide (LPS)-stimulated LC and MC m phi s produced more TNF than m phi s from pigs fed CO, LO, and MO diets. Macrophages from pigs receiving the CO and LC diets had higher (P < .05) levels of leucine aminopeptidase than m phi s from the other dietary groups. Lipopolysaccharide did not increase m phi nitrite production over basal levels except in the MO diet group. However, LPS-stimulated m phi s from the CO, MO, and LC dietary groups produced more nitrite than m phi s from MC-fed pigs. Alveolar lymphocytes from pigs receiving the MC diet produced more T cell growth factors than LO and MO m phi s. Alveolar m phi s from the different dietary groups did not differ in their capacity for non-immune-mediated phagocytosis of fluorescent latex beads. These results indicate that dietary PUFAs can modulate some functions of porcine alveolar immune cells and that this may prove significant for host response to respiratory disease agents.

Evaluation of antibiotics for the elimination of the tonsillar carrier state of Streptococcus suis in pigs.

Seventy clinically normal 13-day-old crossbred pigs from 10 litters from a Streptococcus suis-infected herd were randomly assigned by litter and weight to 7 groups of 10 pigs each to determine whether different antibiotic regimens would eliminate the tonsillar carrier state of S. suis. Six antimicrobial regimens were tested: penicillin intramuscularly (IM) once daily (s.i.d.) for 3 consecutive days; penicillin IM s.i.d. for 5 consecutive days; ampicillin IM s.i.d. for 5 consecutive days; ampicillin per os s.i.d. for 5 consecutive days; ampicillin intranasally s.i.d. for 5 consecutive days; and ceftiofur sodium IM s.i.d. for 5 consecutive days. The seventh group consisted of untreated control pigs. Tonsillar swab samples were collected before treatment, and tonsillar tissue samples were collected after treatment for cultural examination for S. suis. Streptococcus suis was identified in pigs from all groups prior to treatment and after treatment. Pigs did not have clinical signs of disease during the study. All antimicrobial treatments tested in this study failed to eliminate the tonsillar carrier state of S. suis. Early weaning and medication used in this study were not effective for the elimination of the tonsillar carrier state of S. suis in pigs. Optimization of management and environment of pigs coupled with strategic medication of clinically ill animals should be used for control and prevention of mortality caused by streptococcosis.

Infection of pigs by Aujeszky's disease virus via the breath of intranasally inoculated pigs.

Aujeszky's disease is a worldwide problem in the pig industry. In this experiment, four pigs chosen to act as shedder pigs were intranasally infected with Aujeszky's disease virus. Next, on three consecutive days, eight recipient pigs were exposed to the breath of a pair of shedder pigs via a mask-to-mask module. Except for the virtual absence of CNS signs, shedder pigs expressed clinical signs that were similar to pigs infected naturally or experimentally. Only mild respiratory signs occurred in recipient pigs, but all were infected by aerosols of Aujeszky's disease virus as evidenced by seroconversion. The pig is a much more sensitive indicator of airborne virions than our aerosol collection methods. We conclude that the mild respiratory disease acquired by the aerogenous route in recipient pigs is an easily managed model for studying the transmission of airborne respiratory infections and the immune responses to this type of infection.

Relationship between the indicators of performance and the weight of pneumonic lesions from pigs at slaughter.

Lungs from pigs at slaughter were examined and the extent of the lesions was estimated as the percentage by weight of the lung affected by pneumonia in relation to the weight of the whole lung. Linear regression analyses of mean daily gain in liveweight and days to slaughter on the percentage by weight of pneumonic lung were performed. Within a range between 3.32 and 74.55 per cent for the weight of pneumonic lung, a 10 per cent increase in the weight of pneumonic lung was associated with a decrease in mean daily gain of 31.4 g and a 13.2-day increase to slaughter at 104.2 kg liveweight. When subgroups of pigs were evaluated by farm of origin, significant associations between indicators of performance and pneumonia for pigs from only one of the farms were found.

Reproductive performance of sows treated with a combination of pregnant mare's serum gonadotropin and human chorionic gonadotropin at weaning in the summer.

During the summer and fall of 1987, sows from eight herds in three states were assigned randomly to receive either a combination of 400 IU of pregnant mare's serum gonadotropin with 200 IU of hCG (P.G. 600) or no treatment at weaning. A treatment x parity interaction was observed for days to first estrus after treatment and percentage anestrus (percentage of sows not achieving estrus within 10 d after weaning). Relative to primiparous control sows, primiparous sows given P.G. 600 expressed estrus sooner (P less than .02) after weaning (6.0 vs 7.8 +/- .6 d) and exhibited less (P less than .02) postweaning anestrus (15.6 vs 29.2 +/- 4.0%). Second parity sows that received P.G. 600 showed estrus sooner (P less than .06) than second-parity control sows (4.7 vs 6.4 +/- .7 d). Days to first estrus after treatment did not differ between groups for parity-three and older sows, and percentage anestrus was not different between treatments for parity-two and older sows. The herd X treatment interaction was significant for percentage recycled (percentage of successfully mated sows that returned to estrus), subsequent farrowing rate, and subsequent number of pigs born dead. Number of pigs born alive was lower for sows treated with P.G. 600 than for control sows (10.55 vs 10.10 +/- .18; P less than .02). In summary, treatment of sows weaned in the summer and fall with P.G. 600 had decreased days to postweaning estrus in parity-one and -two sows and reduced frequency of postweaning anestrus in primiparous sows.

Aerosol vaccination of pigs against Mycoplasma hyopneumoniae infection.

Aerosol vaccination is used effectively to immunize poultry against Newcastle disease, but to the authors' knowledge, this vaccination procedure is not well studied in other species. The efficacy of IM and aerosol vaccination of pigs against Mycoplasma hyopneumoniae infection was evaluated. Twenty-one pigs from a Mycoplasma-free herd were randomly allotted by litter and body weight into 3 groups. One group was given aerosolized phosphate-buffered saline solution (PBSS) by inhalation. The second group (AERO) was given aerosolized M hyopneumoniae vaccine by inhalation. The third group (IM) was given the same vaccine by IM injection. Vaccination by IM administration was repeated once, and aerosol vaccination was repeated twice at 2-week intervals. Two weeks after the last vaccination, all pigs were intratracheally challenge-exposed with 3 ml of broth culture containing 10(7) color-changing units (CCU) of a low-passage strain of virulent M hyopneumoniae. Pigs were observed daily for coughing. Four weeks after challenge exposure, all pigs were necropsied. Percentage of lung affected by gross pneumonia was measured, bronchioalveolar lavage fluid (BALF) cells were counted, and quantitative culture for mycoplasmas was performed on lung sections. Additionally, M hyopneumoniae-specific antibodies were measured in prevaccination, postvaccination, and postchallenge-exposure serum and BALF by use of indirect ELISA. Mean prevalence of persistent coughing in pigs of the AERO group (4.6 d/pig) was not different from that in pigs of the PBSS group (3.7 d/pig). Prevalence of coughing in IM vaccinated pigs (1.0 d/pig) was lower (P < 0.05) than that in pigs of the PBSS group.(ABSTRACT TRUNCATED AT 250 WORDS)

Association between growth indicators and volume of lesions in lungs from pigs at slaughter.

Conflicting findings exist among studies on the effect of pneumonia on growth in pigs. We determined the extent of pneumonia in market-weight pigs by use of an objective, volumetric method and linear regression analyses of mean daily gain and days-to-slaughter weight on the percentage of pneumonic lung. In a range of extent of pneumonia between 1.33 and 70.44%, a 10% increase in the volume of pneumonic lung was associated with a decrease in mean daily gain by 41.1 g and a 16.7-day increase in number of days to a slaughter weight of 104.5 kg.

Health and growth performance of barrows reared in all-in/all-out or continuous flow facilities with or without a chlortetracycline feed additive.

OBJECTIVE: To compare health and growth performance in barrows reared in all-in/all-out (AIAO) or continuous flow (CF) management systems. ANIMALS: 400 barrows. PROCEDURE: Barrows (approx 2 months old) were allotted to 4 replications (100 barrows each); barrows were housed in AIAO or CF rooms (10 pens/room), and 50 pigs/replicate received chlortetracycline (CTC, 110 mg/kg of feed). Barrows from each pen were slaughtered at 3, 4, 5, and 6 months old. RESULTS: Barrows in the AIAO room had greater total daily gain (TDG) and lean daily gain (LDG) than did barrows in the CF room. Addition of CTC did not improve TDG or LDG in either environment. Barrows in the AIAO room reached body weight of 104.5 kg in 169.7 days, compared with 177.3 days for barrows in the CF room. Feed-to-gain ratio was not affected by management or CTC. Lungs from barrows reared in AIAO facilities had a lower percentage of lesions than did lungs of barrows reared in CF facilities (1.74% vs 9.52%). Addition of CTC did not affect prevalence and extent of lung lesions. Extent of lung lesions was positively correlated with change in serum optical density (OD) to Mycoplasma hyopneumoniae (r = 0.35), but not with change in serum OD to Actinobacillus pleuropneumoniae. Lean growth and serum OD to M. hyopneumoniae and A. pleuropneumoniae were not correlated. CONCLUSIONS: Health and growth performance were better for barrows in an AIAO facility, compared with a CF facility, but addition of CTC to feed failed to enhance health or performance of barrows in either facility.

Factors that influence litter size in swine: parity 3 through 7 females.

The influence of 7 factors on litter size for the combined parities 3 through 7 (age at conception of the first litter, parity-1 litter size, duration of lactation in the preceding parity, weaning-to-conception interval in the preceding parity, farrowing-to-conception interval in the preceding parity, number of matings per conception, and month of conception) was investigated in 11,929 litters from 5 commercial herds. Age at conception of the first litter did not influence litter size in these parities in any herd. In the 4 herds that kept such data, duration of lactation negatively influenced the weaning-to-conception interval, and duration of lactation and weaning-to-conception interval positively influenced the litter size in the next parity. Because the effects of duration of lactation and weaning-to-conception interval could not be investigated separately, their effects on litter size were simultaneously investigated, using the farrowing-to-conception interval for these combined parities. In all herds except one, the increase in live litter size was between 0.02 and 0.09 pig for each day increase in the preceding farrowing-to-conception interval less than 36 days (P less than 0.05). Duration of lactation within this farrowing-to-conception interval similarly influenced litter size. Litter size in litters of any herd was not affected by a preceding farrowing-to-conception interval greater than 35 days. In all herds except one, mean litter size of females with a farrowing-to-conception interval greater than 35 days was 0.26 to 0.96 pig greater (P less than 0.1) than for females with a farrowing-to-conception interval greater than 36 days. In 1 of 3 herds that kept such data, 2 matings per conception resulted in a larger mean live litter size than 1 or 3 matings (P less than 0.05). When these females were grouped on the basis of their conception during one of the 3-month seasonal periods, no influence of season on litter size was found. The effect of parity-1 litter size on litter size of subsequent parities 3 through 7 was significant. The regression coefficient ranged from 0.11 to 0.22 (P less than 0.01) in the farrowing-to-conception interval less than 36 days in all herds. In females with a farrowing-to-conception interval greater than 35 days, this association was significant only in one herd.(ABSTRACT TRUNCATED AT 400 WORDS)

Factors influencing litter size in swine: parity-one females.

The influence of age at conception, number of matings per conception, season of conception, and breed of female on parity-1 litter size was investigated in 4,944 females from 5 commercial swine herds located in North America. The influence of age at conception on reproductive performance of females in subsequent parities also was investigated. As the age at conception increased from 180 to 245 days, litter size increased 0.017 and 0.012 pig per day, respectively, (P less than 0.05) in 2 of the 3 herds that recorded such data. Age at conception did not influence litter size when conception occurred after 245 days of age. Longevity (parity achieved before death or culling) of females was not influenced by age at first conception. Gilts that conceived before 220 days of age had significantly shorter weaning-to-conception intervals in one herd and shorter farrowing-to-conception intervals in another herd throughout subsequent parities. In 1 of 3 herds that recorded such data, live and total litter size increased from 9.46 to 10.46 and 10.16 to 11.50, respectively (P less than 0.05), as number of matings increased from 1 to 3 per conception. No significant influence of number of matings per conception was observed in the other 2 herds. The effect of season of conception was variable among herds. In 2 herds, there was no significant effect of season of conception on subsequent litter size.(ABSTRACT TRUNCATED AT 250 WORDS)

Pathogenicity of a modified-live pseudorabies vaccine virus in lambs.

Subcutaneous injections of modified-live pseudorabies virus (PRV) vaccine into lambs caused clinical signs and death within 1 week after injection in 4 of 5 inoculated lambs. The clinical signs included depression, high fever, muscle fasciculations and convulsions, occasionally followed by death within 48 hours of the initial clinical signs. Histologic examinations and virus isolation procedures demonstrated PRV in the CNS of infected lambs. Sera from sick lambs remained negative for PRV antibodies. Two subsequent serial passages of the vaccine virus in lambs resulted in similar clinical signs and death in 6 of 10 inoculated lambs. Again, PRV was isolated from tissues of sick lambs, and the histopathologic findings were characteristic of the disease. Affected lambs remained seronegative to PRV, as did lambs that remained clinically normal after inoculation. There was no evidence of PRV transmission to uninoculated lambs and pigs housed with the infected lambs.

Use of farrowing rate as a measure of fertility of boars.

The first 100 single-boar services of 140 boars were analyzed to determine whether the farrowing rate resulting from initial services predicted the farrowing rate of subsequent services. The data were analyzed for the influence of parity, number of matings per estrus, season of service, and interaction of these variables on farrowing rate. Sow parity influenced farrowing rate. Sows with parity greater than 8 and gilts had the lowest farrowing rates (P less than 0.01). Sows with parity 2 through 5 had the highest farrowing rates (P less than 0.01). One and 2 matings/estrus resulted in reduced farrowing rates (P less than 0.01), compared with farrowing rates of greater than 2 matings/estrus. Farrowing rate for services during the summer was lower than that for other seasons of the year (P less than 0.01). Evidence of interaction among these variables was not found. Therefore, the results of each service recorded was adjusted to the mean farrowing rate of sows with parity 2 through 5, sows mated greater than or equal to 3 times/service, and sows serviced in the spring. After these adjustments, the farrowing rates for the first 10, 20, 30, 40, and 50 services were analyzed to determine associations with farrowing rates for subsequent services through 100 farrowings. These data also were analyzed to determine whether the associations were strengthened by removal of the first 10 services from the data. The best farrowing rate association indicated that for each 1% increase in farrowing rate subsequent to the first 50 services, the farrowing rate for the second 50 services increased 0.33% (P less than 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)

Interaction of Mycoplasma hyopneumoniae and Pasteurella multocida infections in swine.

To investigate the interaction between Mycoplasma hyopneumoniae and Pasteurella multocida infection, 32 pigs were randomly assigned by litter, sex, and weight to 4 treatment groups. Group-1 pigs were inoculated with M hyopneumoniae and allowed to recover from M hyopneumoniae infection. Group-2 pigs were vaccinated against M hyopneumoniae and then inoculated with M hyopneumoniae. Group-3 pigs were inoculated with M hyopneumoniae and developed clinical signs of mycoplasmosis. Group-4 pigs had never been exposed to M hyopneumoniae. All pigs were initially seronegative for M hyopneumoniae. All pigs were subsequently inoculated with P multocida and euthanatized 2 weeks later. Pasteurella multocida was isolated only from the lungs of group-3 pigs, and these pigs had a significantly higher median percentage of lung surface area affected by pneumonia than did pigs in the other groups. For group-3 pigs, percentage of lung surface area affected by pneumonia was positively correlated with the number of P multocida colonies isolated. We concluded that P multocida is not a primary respiratory pathogen in pigs, but that M hyopneumoniae infection can render the lungs susceptible to P multocida colonization and infection. Pigs recovered from or vaccinated against infection with M hyopneumoniae were resistant to P multocida infection.

Relationship to growth performance of pneumonia and atrophic rhinitis lesions detected in pigs at slaughter among four seasons.

A commercial swine herd was selected for study, because pigs at slaughter repeatedly had lung lesions consistent with enzootic pneumonia and had snout lesions typical of atrophic rhinitis. Pigs born during various seasons of the year were allotted to 4 investigations and were evaluated from birth to slaughter. Individual lungs and snouts were identified and collected at the slaughter plant and later examined for gross lesions of bronchopneumonia and atrophic rhinitis, respectively. Each lesion was scored, and the following comparisons were made within investigations: prevalence and mean scores for lung lesions; prevalence and mean grades for snout lesions; correlations between lung lesion scores and growth indicators; correlations between snout lesion grades and growth indicators; and correlations between lung lesion scores and snout grade scores. Included in the growth indicators were average daily gain during the growing phase, average daily gain during the finishing phase, average daily gain during growing and finishing phases, and days to attain 104.5 kg of body weight. Prevalence of lung or snout lesions, mean values for lung lesion scores, mean values for snout lesion grades, and mean values for the various growth indicators were tested for statistical differences among the 4 investigations. Prevalence of lung lesions was highest (96%) for winter-slaughtered and lowest (81%) for autumn-slaughtered pigs. Mean scores for lung lesions were 7% (summer), 5% (autumn), 9% (winter), and 16% (spring). Prevalence of snout lesions was highest (85%) for spring-slaughtered pigs and lowest (42%) for autumn-slaughtered pigs.(ABSTRACT TRUNCATED AT 250 WORDS)

Epizootic of pseudorabies among ten swine herds.

An epizootic of pseudorabies in 10 swine herds located near Greensburg in Decatur County, Indiana was investigated. Records of Decatur County swine herds previously quarantined because of pseudorabies were obtained. For the 1988 epizootic, clinical findings were considered, location of each of the 10 swine herds in relation to the other herds was determined, and potential fomites were considered. Meteorologic data prior to, during, and after the epizootic were obtained, correlated, and analyzed. A source-receptor model, based on wind direction and speed data, was used to determine whether weather conditions in the Greensburg area enhanced the potential for aerosol spread of pseudorabies virus between herds. On the basis of lack of other modes of spread of pseudorabies and on meteorologic and source-receptor data, aerosol transmission of pseudorabies virus between the 10 herds was probable.

Relationship of growth performance to pneumonia and atrophic rhinitis detected in pigs at slaughter.

Three commercial swine herds were selected for study, because pigs at slaughter consistently had lung lesions typical of bronchopneumonia and snout lesions consistent with atrophic rhinitis. Pigs were reared in the conventional system for each herd except that they were identified at birth and weighted at various intervals. At slaughter, individual pig lungs and snout were examined for lesions of pneumonia and atrophic rhinitis, respectively. Lesions were scored and correlated with growth indicators for each pig. Included in the growth indicators were: average daily gain (growing phase), average daily gain (finishing phase), average daily gain (total), and days to reach 104.5-kg body weight. Additionally, for each pig, scores for lung lesions were correlated to grades for snout lesions. Three correlation coefficients for measurements of pigs within herd B were significant and included days to 104.5-kg body weight and grades for snout lesions, -0.15 (P less than 0.02); average daily gain (finishing) and grades for snout lesions, 0.17 (P less than 0.01); and average daily gain (total) and grades for snout lesions, 0.16 (P less than 0.01). Contrary to findings in other investigations, pigs that attained market weight at the youngest age did not have the lowest score for lung lesions, the lowest grade for snout lesions, or the least extensive or severe lesions. Combining data from all 3 herds, the mean scores for lung lesions and mean grades for snout lesions decreased significantly (P less than 0.05) as the age of pigs at slaughter increased. All other statistical correlations were not significant.(ABSTRACT TRUNCATED AT 250 WORDS)

Procedures for preventing the transmission of foot-and-mouth disease virus to pigs and sheep by personnel in contact with infected pigs.

The most effective method of containing an outbreak of foot-and-mouth disease (FMD) is by the culling of livestock. However, qualified people must diagnose the disease before the culling can begin, and they must avoid susceptible animals after having been in contact with infected premises, to prevent them from transmitting the virus. To test the effectiveness of biosecurity procedures in preventing the transmission of FMD virus (O/UK/35/2001) investigators contacted and sampled pigs inoculated with FMD virus for approximately 45 minutes and then contacted and sampled sentinel pigs and sheep after either using no biosecurity procedures, or washing their hands and donning clean outerwear, or showering and donning clean outerwear. The virus was detected in the nasal secretions of one investigator immediately after the postmortem investigation of the inoculated pigs but was not detected in samples collected between approximately 12 and 84 hours later. After the contaminated personnel had showered and changed into clean outerwear they did not transmit the strain of FMD virus to susceptible pigs and sheep.