Therapeutic and Economic Benefits of Service Dogs Versus Emotional Support Dogs for Veterans With PTSD.

OBJECTIVE: This work aimed to assess the therapeutic and economic benefits of service dogs versus emotional support dogs for veterans with posttraumatic stress disorder (PTSD). METHODS: Veterans with PTSD (N=227) participating in a multicenter trial were randomly assigned to receive a service or emotional support dog; 181 veterans received a dog and were followed up for 18 months. Primary outcomes included overall functioning (assessed with World Health Organization Disability Assessment Scale II [WHODAS 2.0]) and quality of life (Veterans RAND 12-Item Health Survey [VR-12]). Secondary outcomes included PTSD symptoms (PTSD Checklist for DSM-5), suicidal ideation, depression, sleep quality, health care costs and utilization, medication adherence, employment, and productivity. RESULTS: Participants paired with a dog had a mean±SD age of 50.6±13.6 years (range 22-79), and most were male (80%), White (66%), and non-Hispanic (91%). Adjusted linear mixed repeated-measures models indicated no difference between the two groups on WHODAS 2.0 or VR-12 scores. Participants with service dogs had a 3.7-point greater reduction in PTSD symptoms versus participants with emotional support dogs (p=0.036). No reduced health care utilization or cost was associated with receiving a service dog. Veterans with service dogs had an increase of 10 percentage points in antidepressant adherence compared with those with emotional support dogs (p<0.01). CONCLUSIONS: Both groups appeared to benefit from having a service or emotional support dog. No significant differences in improved functioning or quality of life were observed between the groups. Those in the service dog group had a greater reduction in PTSD symptoms and better antidepressant adherence, improvements that should be explored further.

How VA Innovative Partnerships and Health Care Systems Can Respond to National Needs: NOSE Trial Example.

Background: At the onset of COVID-19, essential supplies were not obtainable from manufacturers. This caused patients and clinicians to have additional risk and exposure to COVID-19 in some settings and the wasting of critical materials when testing was unavailable in other settings. Observations: The Veterans Health Administration (VHA) developed and enacted contingency plans for depleted supplies under both its First Mission-to care for veterans-and its Fourth Mission- to support the American health care system in times of crisis. A partnership among the VHA, US Food and Drug Administration, the National Institutes of Health, and America Makes addressed national shortages with the curation and development of designs, testing protocols, product evaluation, and product validation. VHA leveraged digital manufacturing to produce nasopharyngeal swabs onsite-3-dimensional-printed nasal swabs-and validate them to cover the gap between stockpile depletion and ramp up of traditional product manufacturing. Conclusions: This effort involved close collaboration between innovators and researchers within the organization and alongside government, industry, and academic partners. We illustrate this collaborative concept here with a use case of nasal swabs to demonstrate successes and lessons learned that are shaping how the VHA in conjunction with government and industry partners can shepherd this new strategy for crisis preparedness.

Design and challenges for a randomized, multi-site clinical trial comparing the use of service dogs and emotional support dogs in Veterans with post-traumatic stress disorder (PTSD).

Posttraumatic stress disorder (PTSD) is a leading cause of impairments in quality of life and functioning among Veterans. Service dogs have been promoted as an effective adjunctive intervention for PTSD, however published research is limited and design and implementation flaws in published studies limit validated conclusions. This paper describes the rationale for the study design, a detailed methodological description, and implementation challenges of a multisite randomized clinical trial examining the impact of service dogs on the on the functioning and quality of life of Veterans with PTSD. Trial design considerations prioritized participant and intervention (dog) safety, selection of an intervention comparison group that would optimize enrollment in all treatment arms, pragmatic methods to ensure healthy well-trained dogs, and the selection of outcomes for achieving scientific and clinical validity in a Veteran PTSD population. Since there is no blueprint for conducting a randomized clinical trial examining the impact of dogs on PTSD of this size and scope, it is our primary intent that the successful completion of this trial will set a benchmark for future trial design and scientific rigor, as well as guiding researchers aiming to better understand the role that dogs can have in the management of Veterans experiencing mental health conditions such as PTSD.

Cochlear compression estimates from measurements of distortion-product otoacoustic emissions.

Evidence of the compressive growth of basilar-membrane displacement can be seen in distortion-product otoacoustic emission (DPOAE) levels measured as a function of stimulus level. When the levels of the two stimulus tones (f1 and f2) are related by the formula L1 = 39 dB + 0.4 x L2 [Kummer et al., J. Acoust. Soc. Am. 103, 3431-3444 (1998)] the shape of the function relating DPOAE level to L2 is similar (up to an L2 of 70 dB SPL) to the classic Fletcher and Munson [J. Acoust. Soc. Am. 9, 1-10 (1933)] loudness function when plotted on a logarithmic scale. Explicit estimates of compression have been derived based on recent DPOAE measurements from the laboratory. If DPOAE growth rate is defined as the slope of the DPOAE I/O function (in dB/dB), then a cogent definition of compression is the reciprocal of the growth rate. In humans with normal hearing, compression varies from about 1 at threshold to about 4 at 70 dB SPL. With hearing loss, compression is still about 1 at threshold, but grows more slowly above threshold. Median DPOAE I/O data from ears with normal hearing, mild loss, and moderate loss are each well fit by log functions. When the I/O function is logarithmic, then the corresponding compression is a linear function of stimulus level. Evidence of cochlear compression also exists in DPOAE suppression tuning curves, which indicate the level of a third stimulus tone (f3) that reduces DPOAE level by 3 dB. All three stimulus tones generate compressive growth within the cochlea; however, only the relative compression (RC) of the primary and suppressor responses is observable in DPOAE suppression data. An RC value of 1 indicates that the cochlear responses to the primary and suppressor components grow at the same rate. In normal ears, RC rises to 4, when f3 is an octave below f2. The similarities between DPOAE and loudness compression estimates suggest the possibility of predicting loudness growth from DPOAEs; however, intersubject variability makes such predictions difficult at this time.

Distortion product otoacoustic emission suppression tuning curves in normal-hearing and hearing-impaired human ears.

Distortion product otoacoustic emission (DPOAE) suppression measurements were made in 20 subjects with normal hearing and 21 subjects with mild-to-moderate hearing loss. The probe consisted of two primary tones (f2, f1), with f2 held constant at 4 kHz and f2/f1 = 1.22. Primary levels (L1, L2) were set according to the equation L1 = 0.4 L2 + 39 dB [Kummer et al., J. Acoust. Soc. Am. 103, 3431-3444 (1998)], with L2 ranging from 20 to 70 dB SPL (normal-hearing subjects) and 50-70 dB SPL (subjects with hearing loss). Responses elicited by the probe were suppressed by a third tone (f3), varying in frequency from 1 octave below to 1/2 octave above f2. Suppressor level (L3) varied from 5 to 85 dB SPL. Responses in the presence of the suppressor were subtracted from the unsuppressed condition in order to convert the data into decrements (amount of suppression). The slopes of the decrement versus L3 functions were less steep for lower frequency suppressors and more steep for higher frequency suppressors in impaired ears. Suppression tuning curves, constructed by selecting the L3 that resulted in 3 dB of suppression as a function of f3, resulted in tuning curves that were similar in appearance for normal and impaired ears. Although variable, Q10 and Q(ERB) were slightly larger in impaired ears regardless of whether the comparisons were made at equivalent SPL or equivalent sensation levels (SL). Larger tip-to-tail differences were observed in ears with normal hearing when compared at either the same SPL or the same SL, with a much larger effect at similar SL. These results are consistent with the view that subjects with normal hearing and mild-to-moderate hearing loss have similar tuning around a frequency for which the hearing loss exists, but reduced cochlear-amplifier gain.

Further efforts to predict pure-tone thresholds from distortion product otoacoustic emission input/output functions.

Recently, Boege and Janssen [J. Acoust. Soc. Am. 111, 1810-1818 (2002)] fit linear equations to distortion product otoacoustic emission (DPOAE) input/output (UO) functions after the DPOAE level (in dB SPL) was converted into pressure (in microPa). Significant correlations were observed between these DPOAE thresholds and audiometric thresholds. The present study extends their work by (1) evaluating the effect of frequency, (2) determining the behavioral thresholds in those conditions that did not meet inclusion criteria, and (3) including a wider range of stimulus levels. DPOAE I/O functions were measured in as many as 278 ears of subjects with normal and impaired hearing. Nine f2 frequencies (500 to 8000 Hz in 1/2-octave steps) were used, L2 ranged from 10 to 85 dB SPL (5-dB steps), and L1 was set according to the equation L1 = 0.4L2 + 39 dB [Kummer et al., J. Acoust. Soc. Am. 103, 3431-3444 (1998)] for L2 levels up to 65 dB SPL, beyond which L1 = L2. For the same conditions as those used by Boege and Janssen, we observed a frequency effect such that correlations were higher for mid-frequency threshold comparisons. In addition, a larger proportion of conditions not meeting inclusion criteria at mid and high frequencies had hearing losses exceeding 30 dB HL, compared to lower frequencies. These results suggest that DPOAE I/O functions can be used to predict audiometric thresholds with greater accuracy at mid and high frequencies, but only when certain inclusion criteria are met. When the SNR inclusion criterion is not met, the expected amount of hearing loss increases. Increasing the range of input levels from 20-65 dB SPL to 10-85 dB SPL increased the number of functions meeting inclusion criteria and increased the overall correlation between DPOAE and behavioral thresholds.

Sources of DPOAEs revealed by suppression experiments, inverse fast Fourier transforms, and SFOAEs in impaired ears.

DPOAE sources are modeled by intermodulation distortion generated near the f2 place and a reflection of this distortion near the DP place. In a previous paper, inverse fast Fourier transforms (IFFTs) of DPOAE filter functions in normal ears were consistent with this model [Konrad-Martin et al., J. Acoust. Soc. Am. 109, 2862-2879 (2001)]. In the present article, similar measurements were made in ears with specific hearing-loss configurations. It was hypothesized that hearing loss at f2 or DP frequencies would influence the relative contributions to the DPOAE from the corresponding basilar membrane places, and would affect the relative magnitudes of SFOAEs at frequencies equal to f2 and fDP. DPOAEs were measured with f2 = 4 kHz, f1 varied, and a suppressor near fDP. L2 was 25-55 dB SPL (L1 = L2 + 10 dB). SFOAEs were measured at f2 and at 2.7 kHz (the average fDP produced by the f1 sweep) for stimulus levels of 20-60 dB SPL. SFOAE results supported predictions of the pattern of amplitude differences between SFOAEs at 4 and 2.7 kHz for sloping losses, but did not support predictions for the rising- and flat-loss categories. Unsuppressed IFFTs for rising losses typically had one peak. IFFTs for flat or sloping losses typically have two or more peaks; later peaks were more prominent in ears with sloping losses compared to normal ears. Specific predictions were unambiguously supported by the results for only four of ten cases, and were generally supported in two additional cases. Therefore, the relative contributions of the two DPOAE sources often were abnormal in impaired ears, but not always in the predicted manner.

The use of distortion product otoacoustic emission suppression as an estimate of response growth.

Distortion product otoacoustic emission (DPOAE) levels in response to primary pairs (f2 = 2 or 4 kHz, L2 ranging from 20 to 60 dB SPL, L1 = 0.4L2 + 39 dB) were measured with and without suppressor tones (f3), which varied from 1 octave below to 1/2 octave above f2, in normal-hearing subjects. Suppressor level (L3) varied from -5 to 85 dB SPL. DPOAE levels were converted into decrements by subtracting the level in the presence of the suppressor from the level in the absence of a suppressor. DPOAE decrement vs L3 functions showed steeper slopes when f3 < f2 and shallower slopes when f3 > f2. This pattern is similar to other measurements of response growth, such as direct measures of basilar-membrane motion, single-unit rate-level functions, suppression of basilar-membrane motion, and discharge-rate suppression from lower animals. As L2 increased, the L3 necessary to maintain 3 dB of suppression increased at a rate of about 1 dB/dB when f3 was approximately equal to f2, but increased more slowly when f3 < f2. Functions relating L3 to L2 in order to maintain a constant 3-dB reduction in DPOAE level were compared for f3 < f2 and for f3 approximately = f2 in order to derive an estimate related to "cochlear-amplifier gain." These results were consistent with the view that "cochlear gain" is greater at lower input levels, decreasing as level increases.

Evidence of upward spread of suppression in DPOAE measurements.

Measurements of DPOAE level in the presence of a suppressor were used to describe a pattern that is qualitatively similar to population studies in the auditory nerve and to behavioral studies of upward spread of masking. DPOAEs were measured in the presence of a suppressor (f3) fixed at either 2.1 or 4.2 kHz, and set to each of seven levels (L3) from 20 to 80 dB SPL. In the presence of a fixed f3 and L3 combination, f2 was varied from about 1 oct below to at least 1/2 oct above f3, while L2 was set to each of 6 values (20-70 dB SPL). L1 was set according to the equation L1 = 0.4L2 + 39 [Janssen et al., J. Acoust. Soc. Am. 103, 3418-3430 (1998)]. At each L2, L1 combination, DPOAE level was measured in a control condition in which no suppressor was presented. Data were converted into decrements (the amount of suppression, in dB) by subtracting the DPOAE level in the presence of each suppressor from the DPOAE level in the corresponding control condition. Plots of DPOAE decrements as a function of f2 showed maximum suppression when f2 approximately = f3. As L3 increased, the suppressive effect spread more towards higher f2 frequencies, with less spread towards lower frequencies relative to f3. DPOAE decrement versus L3 functions had steeper slopes when f2 > f3, compared to the slopes when f2 < f3. These data are consistent with other findings that have shown that response growth for a characteristic place (CP) or frequency (CF) depends on the relation between CP or CF and driver frequency, with steeper slopes when driver frequency is less than CF and shallower slopes when driver frequency is greater than CF. For a fixed amount of suppression (3 dB), L3 and L2 varied nearly linearly for conditions in which f3 approximately = f2, but grew more rapidly for conditions in which f3 < f2, reflecting the basal spread of excitation to the suppressor. The present data are similar in form to the results observed in population studies from the auditory nerve of lower animals and in behavioral masking studies in humans.