Despite receiving postacute rehabilitation services, many older women with a recent hip fracture repair are unable to return to their prefracture level of function. Whether testosterone therapy can enhance recovery after hip fracture in older women with persistent mobility impairments has not been fully examined. To evaluate the effects of a supervised exercise program combined with topical testosterone therapy on functional outcomes in older women with a recent hip fracture. This phase 3 double-blind, placebo-controlled randomized clinical trial, Starting a Testosterone and Exercise Program After Hip Injury (STEP-HI), was conducted at 8 US sites between December 2018 and August 2023. Participants were women aged 65 years or older with a recent surgical repair of a nonpathologic femur fracture, met objective criteria for mobility impairment, and were community dwelling after discharge from rehabilitation. During the first 14 months of the trial, participants were randomly assigned to 1 of 3 treatment groups: exercise plus topical testosterone gel, exercise plus placebo gel, or enhanced usual care. Statistical analysis, using a modified intention-to-treat approach, was performed from November 2023 to November 2024. For 24 weeks, the 2 exercise groups underwent a supervised, multimodal high-intensity exercise program that included progressive resistance training with trained and certified exercise interventionists. Testosterone was provided in the form of a topical gel (generic 1.0% testosterone), and the placebo gel was chemically identical but without testosterone. The enhanced usual care group was prescribed a self-administered low-intensity home-based exercise program and a staff-led monthly health education session. The primary outcome was the between-group difference in the change in the 6-minute walking distance (6MWD) from baseline to 24 weeks. Among the 129 women randomized (54 to the exercise plus testosterone group, 55 to the exercise plus placebo group, and 20 to the enhanced usual care group; mean [SD] age, 79.3 [8.4] years) included in the STEP-HI trial (122 (94.6%) provided primary outcome data for baseline and at least 1 time point (12 or 24 weeks). The mean (SD) change in the 6MWD between baseline and 24 weeks was not significantly different for exercise plus topical testosterone gel (n = 53; 42.7 [8.2] m) compared with exercise plus placebo gel (n = 51; 40.5 [8.4] m) and enhanced usual care (n = 18; 37.7 [14.8] m). In the STEP-HI randomized clinical trial, supervised exercise training combined with testosterone therapy conducted in older women recovering from a hip fracture did not lead to significant improvement in 6MWD compared with supervised exercise alone. Adding testosterone therapy to exercise may not provide further benefits for long-distance mobility. Whether it can improve physical performance and mobility for short distances in this patient population warrants further study. ClinicalTrials.gov Identifier: NCT02938923

Background. Chronic lung allograft dysfunction (CLAD) is the leading cause of death beyond the first year after lung transplantation. The development of donor-specific antibodies (DSA) is a recognized risk factor for CLAD. Based on experience in kidney transplantation, we hypothesized that belatacept, a selective T-cell costimulatory blocker, would reduce the incidence of DSA after lung transplantation, which may ameliorate the risk of CLAD. Methods. We conducted a pilot randomized controlled trial (RCT) at 2 sites to assess the feasibility and inform the design of a large-scale RCT. All participants were treated with rabbit antithymocyte globulin for induction immunosuppression. Participants in the control arm were treated with tacrolimus, mycophenolate mofetil, and prednisone, and participants in the belatacept arm were treated with tacrolimus, belatacept, and prednisone through day 89 after transplant then converted to belatacept, mycophenolate mofetil, and prednisone for the remainder of year 1. Results. After randomizing 27 participants, 3 in the belatacept arm died compared with none in the control arm. As a result, we stopped enrollment and treatment with belatacept, and all participants were treated with standard-of-care immunosuppression. Overall, 6 participants in the belatacept arm died compared with none in the control arm (log rank P = 0.008). We did not observe any differences in the incidence of DSA, acute cellular rejection, antibody-mediated rejection, CLAD, or infections between the 2 groups. Conclusions. We conclude that the investigational regimen used in this pilot RCT is associated with increased mortality after lung transplantation.

Abstract The STEP-HI Study tested if testosterone replacement therapy in combination with resistance exercise training for 6 months could improve functional recovery from hip fracture in older women more than resistance exercise alone or standard of care. Here we present the results of the intention to treat analyses (N=122) of the effect of testosterone replacement plus exercise (EX+T, n=53) vs. exercise plus placebo (EX+P, n=51) vs. enhanced usual care (EUC, n=18) on the Short Physical Performance Battery (SPPB) scores, maximal leg press strength, and appendicular lean mass. Group differences were analyzed with contrasts using a mixed model repeated analysis of variance that included the following covariates for each outcome: clinical site, age, days since hip surgery, BMI, hip fracture type, general depression score, lung disease, comorbidity index and baseline level. EX+T had a greater improvement in SPPB score than EX+P (p<0.009). Maximal leg press strength increased in all groups by the end of the intervention period with no differences between groups (p>0.05). Appendicular lean mass increased to the same extent in the EX+T and EX+P groups, but slightly decreased in the EUC group as compared to EX+T (p=0.020) and EX+P (p=0.029). These findings suggest that testosterone may independently impact a composite measure of physical performance, while exercise significantly improves appendicular lean mass independent of testosterone replacement. The implications of these findings will be discussed.

Background:Heart failure (HF) is a debilitating and often fatal disease that affects millions of people worldwide. Diminished nitric oxide synthesis, signaling, and bioavailability are believed to contribute to poor skeletal muscle function and aerobic capacity. The aim of this clinical trial (iNIX-HF) is to determine the acute and longer-term effectiveness of inorganic nitrate supplementation on exercise performance in patients with HF with reduced ejection fraction (HFrEF). Methods:This clinical trial is a double-blind, placebo-controlled, randomized, parallel-arm design study in which patients with HFrEF (n = 75) are randomized to receive 10 mmol potassium nitrate (KNO3) or a placebo capsule daily for 6 wk. Primary outcome measures are muscle power determined by isokinetic dynamometry and peak aerobic capacity (VO2peak) determined during an incremental treadmill exercise test. Endpoints include the acute effects of a single dose of KNO3 and longer-term effects of 6 wk of KNO3. The study is adequately powered to detect expected increases in these outcomes at P < 0.05 with 1-β>0.80. Discussion:The iNIX-HF phase II clinical trial will evaluate the effectiveness of inorganic nitrate supplements as a new treatment to ameliorate poor exercise capacity in HFrEF. This study also will provide critical preliminary data for a future 'pivotal', phase III, multi-center trial of the effectiveness of nitrate supplements not only for improving exercise performance, but also for improving symptoms and decreasing other major cardiovascular endpoints. The potential public health impact of identifying a new, relatively inexpensive, safe, and effective treatment that improves overall exercise performance in patients with HFrEF is significant.

The development of donor-specific antibodies (DSA) after lung transplantation is common and results in adverse outcomes. In kidney transplantation, Belatacept has been associated with a lower incidence of DSA, but experience with Belatacept in lung transplantation is limited. We conducted a two-center pilot randomized controlled trial of de novo immunosuppression with Belatacept after lung transplantation to assess the feasibility of conducting a pivotal trial. Twenty-seven participants were randomized to Control (Tacrolimus, Mycophenolate Mofetil, and prednisone, n= 14) or Belatacept-based immunosuppression (Tacrolimus, Belatacept, and prednisone until day 89 followed by Belatacept, Mycophenolate Mofetil, and prednisone, n= 13). All participants were treated with rabbit anti-thymocyte globulin for induction immunosuppression. We permanently stopped randomization and treatment with Belatacept after three participants in the Belatacept arm died compared to none in the Control arm. Subsequently, two additional participants in the Belatacept arm died for a total of five deaths compared to none in the Control arm (log rank p= .016). We did not detect a significant difference in DSA development, acute cellular rejection, or infection between the two groups. We conclude that the investigational regimen used in this study is associated with increased mortality after lung transplantation.

The development of donor-specific antibodies (DSA) after lung transplantation is common and results in adverse outcomes. In kidney transplantation, Belatacept has been associated with a lower incidence of DSA, but experience with Belatacept in lung transplantation is limited. We conducted a 2-center pilot randomized controlled trial ofde novoimmunosuppression with Belatacept after lung transplantation to assess the feasibility of conducting a pivotal trial. Twenty-seven participants were randomized to Control (Tacrolimus, Mycophenolate Mofetil, and prednisone, n = 14) or Belatacept-based immunosuppression (Tacrolimus, Belatacept, and prednisone until day 89 followed by Belatacept, Mycophenolate Mofetil, and prednisone, n = 13). All participants were treated with rabbit anti-thymocyte globulin for induction immunosuppression. We permanently stopped randomization and treatment with Belatacept after 3 participants in the Belatacept arm died compared to none in the Control arm. Subsequently, 2 additional participants in the Belatacept arm died for a total of 5 deaths compared to none in the Control arm (log rank p = 0.016). We did not detect a significant difference in DSA development, acute cellular rejection, or infection between the 2 groups. We conclude that this investigational regimen using Belatacept after lung transplantation is associated with significantly increased mortality.

PURPOSE: To describe a hierarchical fidelity approach to remotely certify exercise interventionists (EIs) and monitor an exercise intervention for a multi-site randomized control trial—Starting a Testosterone and Exercise Program After Hip Injury (STEP-HI) Study (NCT02938923). METHODS: The clinical coordinating center (CCC) is responsible for fidelity at all sites, and the supervising physical therapist (SPT) is responsible for fidelity at their respective site. Fidelity involves 3 steps (Figure 1). Step 1: EIs record one mock session for both intervention phases: P1 and P2; the SPT scores the session with the Fidelity Checklist, and if the EI scores ≥90%, the video is scored by the CCC. EI certification requires agreement between the SPT and CCC of a passing score (≥90%) for both phases. If the EI does not pass (<90%), individualized remediation and further training is required. Step 2: the SPT completes 2 fidelity checklists for P1 and P2 (4 total) using the EI’s first 3 participants. 2 of the 4 assessments are recorded and sent to the CCC for scoring. Step 3: the SPT completes 1 fidelity assessment per month during P1 or P2. Once every 6 months, the fidelity assessment is recorded and sent to the CCC for scoring. RESULTS: Preliminary results are for CCC roles. Step 1: 19 EIs completed training; mean ± SD scores were 93.6% ± 3.3 for P1 and 93.9% ± 2.2 for P2; 5 EIs were in-progress. Step 2: 3 EIs completed initial certification requirements, 10 EIs were in-progress, and 4 EIs had not started. SPTs and CCC had 100% agreement for passing (yes/no) for all assessments (n = 15). The average absolute percent difference between SPT and CCC scores was 3.06% ± 1.49. Step 3: 1 EI completed a 6-month fidelity assessment. CONCLUSIONS: The CCC and SPTs successfully implemented this hierarchical fidelity plan for remote certification and monitoring. The remote approach reduced travel needs and associated costs and facilitated training and monitoring during the pandemic when travel was restricted.

Depressive symptoms are common in older adults after a disabling medical event and interfere with rehabilitation and recovery from the disability. This prospective study examined the role of genetic polymorphisms implicated in synaptic integrity and stress-associated depression as predictors of depressive symptoms after hip fracture. We recruited healthy comparisons from the community and participants with hip fracture after surgical fixation from Saint Louis, Missouri hospitals. We examined the valine (Val) to methionine (Met) polymorphism in brain-derived neurotrophic factor (BDNF), serotonin 1A receptor (5HT1a-rs6295) polymorphism, and the serotonin transporter-linked polymorphic region (5HTTLPR) interaction with the rs25531 A to G single nucleotide polymorphism (5HTTLPR-rs25531) as predictors of depressive symptoms. We also examined whether depressive symptoms mediate the influence of BDNF genotype on functional recovery. Among 429 participants with hip fracture, BDNF Met/Met carriers developed significantly more depressive symptoms than Val/Val carriers during a four-week period after the fracture (p=.012). BDNF genotype also predicted functional recovery over the ensuing year, mediated by its effects on depressive symptoms (CI: 0.07-3.37). Unlike prior studies of stressful life events, the S' 5HTTLPR-rs25531 variant did not predict higher levels of depressive symptoms; instead, we report an exploratory finding of an epistatic effect between BDNF and 5HTTLPR-rs25531 whereby the compounded effects of two LA alleles and BDNF Met/Met genotype elevate risk of depressive symptoms after hip fracture (p=.006). No differences between 5HT1a genotypes were found. Our findings suggest plasticity-related genetic factors contribute to the neural mechanisms of mental and functional well-being after a disabling medical stressor.

BackgroundMindfulness‐based stress reduction (MBSR) has the potential to reduce worry and improve cognitive functioning.ObjectivesIn this treatment development project, we examined MBSR in older adults with worry symptoms and co‐occurring cognitive dysfunction. We examined (i) acceptability of MBSR, (ii) whether MBSR needs to be lengthened providing more repetition, (iii) MBSR's benefits for worry reduction and cognitive improvements, and (iv) continued use of MBSR techniques during follow‐up.MethodsTwo sites (St. Louis and San Diego) enrolled individuals aged 65 years or older with significant anxiety‐related distress plus subjective cognitive dysfunction, into traditional 8‐session MBSR groups and 12‐session groups that had the same content but more repetition of topics and techniques. We examined measures of mindfulness, worry, and a neuropsychological battery focused on memory and executive function before and after the MBSR program, and we followed up participants for 6 months after the completion of MBSR regarding their continued use of its techniques.ResultsParticipants (N = 34) showed improvements in worry severity, increases in mindfulness, and improvements in memory as measured by paragraph learning and recall after a delay, all with a large effect size. Most participants continued to use MBSR techniques for 6 months post‐instruction and found them helpful in stressful situations. There was no evidence that the extended 12‐week MBSR produced superior cognitive or clinical outcomes, greater satisfaction, or greater continuation of MBSR techniques than 8‐week MBSR.ConclusionsThese preliminary findings are promising for the further testing and use of MBSR in older adults suffering from clinical worry symptoms and co‐occurring cognitive dysfunction. These are common problems in a broad range of older adults, many of whom have anxiety and mood disorders; therefore, stress reduction intervention for them may have great public health value. Copyright © 2014 John Wiley & Sons, Ltd.

Objectives: In older adults with anxiety disorders, chronically elevated cortisol may contribute to cognitive impairment and elevated anxiety. We conducted a pilot study with mifepristone, a glucocorticoid receptor antagonist, as a potential treatment for late-life anxiety disorders and co-occurring cognitive dysfunction.Methods: Fifteen individuals 60 years and older with an anxiety disorder plus cognitive dysfunction participated in the 12-week study. In the first week, participants were randomly assigned to mifepristone 300 mg daily or placebo. In the subsequent 3 weeks, all participants received mifepristone 300 mg. Mifepristone was then discontinued, and the participants were reassessed 8 weeks later. We examined the following: (1) cognitive changes; (2) worry symptom severity; (3) safety and tolerability; and (4) salivary cortisol before, during, and after mifepristone exposure.Results: Overall safety, tolerability, and high retention supported the feasibility of this research. Participants with higher baseline cortisol levels (peak cortisol > 6.0 ng/ ml, n = 5) showed improvements inmemory, executive function, and worry severity after 3-4weeks of mifepristone with persistent memory and worry improvements 8 weeks after mifepristone discontinuation. Individuals with low-to-normal baseline cortisol (n = 8) showed little to no improvement. As expected, cortisol levels rose during mifepristone exposure and returned to pretreatment levels 8weeks after mifepristone discontinuation. In the first week of treatment, there were no differences between placebo-treated and mifepristone-treated participants.Conclusion: The results of this pilot study warrant further testing of antiglucocorticoid agents in late-life anxiety disorders with co-occurring cognitive dysfunction. Mifepristone is hypothesized to have benefits in patients with evidence of glucocorticoid excess. Directions for further study are discussed. Copyright (C) 2014 John Wiley & Sons, Ltd.

Risk of developing depressive symptoms after a medical stressor may have a genetic component. Disabling medical events, such as hip fracture, cause pain and immobilization, require hospitalization, surgery, rehabilitation, and can often trigger depressive symptoms such as changes in appetite, affect, lassitude, and sleep. However, there is variability in depressive symptoms in the elderly population, such that most older adults do not suffer from a high number of depressive symptoms after a medical stressor.

Objective: Antidepressant side effects are a significant public health issue, associated with poor adherence, premature treatment discontinuation, and, rarely, significant harm. Older adults assume the largest and most serious burden of medication side effects. We investigated the association between antidepressant side effects and genetic variation in the serotonin system in anxious, older adults participating in a randomized, placebo-controlled trial of the selective serotonin reuptake inhibitor (SSRI) escitalopram. Methods: Adults (N = 177) aged >= 60 years were randomized to active treatment or placebo for 12 weeks. Side effects were assessed using the Udvalg fur Kliniske Undersogelser side-effect rating scale. Genetic polymorphisms were putative functional variants in the promoters of the serotonin transporter and 1A and 2A receptors (5-HTTLPR [L/S + rs25531], HTR1A rs6295, HTR2A rs6311, respectively). Results: Four significant drugeplacebo side-effect differences were found: increased duration of sleep, dry mouth, diarrhea, and diminished sexual desire. Analyses using putative high- versus low-transcription genotype groupings revealed six pharmacogenetic effects: greater dry mouth and decreased sexual desire for the low-and high-expressing serotonin transporter genotypes, respectively, and greater diarrhea with the 1A receptor low-transcription genotype. Diminished sexual desire was experienced significantly more by high-expressing genotypes in the serotonin transporter, 1A, or 2A receptors. There was not a significant relationship between drug concentration and side effects nor a mean difference in drug concentration between low-and high-expressing genotypes. Conclusion: Genetic variation in the serotonin system may predict who develops common SSRI side effects and why. More work is needed to further characterize this genetic modulation and to translate research findings into strategies useful for more personalized patient care.

Attaining and demonstrating treatment fidelity is critical in the development and testing of evidence-based interventions. Treatment fidelity refers to the extent to which an intervention was implemented in clinical testing as it was conceptualized and is clearly differentiable from control or standard-of-care interventions. In clinical research, treatment fidelity is typically attained through intensive training and supervision techniques and demonstrated by measuring therapist adherence and competence to the protocol using external raters. However, in occupational and physical therapy outcomes research, treatment fidelity methods have not been used, which, in our view, is a serious gap that impedes novel treatment development and testing in these rehabilitation fields. In this article, we describe the development of methods to train and supervise therapists to attain adequate treatment fidelity in a treatment development project involving a novel occupational and physical therapy-based intervention. We also present a data-driven model for demonstrating therapist adherence and competence in the new treatment and its differentiation from standard of care. In doing so, we provide an approach that rehabilitation researchers can use to address treatment fidelity in occupational and physical therapy-based interventions. We recommend that all treatment researchers in rehabilitation disciplines use these or similar methods as a vital step in the development and testing of evidence-based rehabilitation interventions.

ObjectiveOlder adults with anxiety disorders are burdened by impairment in neurocognition, which may be mediated by elevated circulating cortisol levels. In a randomized controlled trial of acute serotonin‐reuptake inhibitor treatment for late‐life anxiety disorder, we examined whether change in salivary cortisol concentrations during treatment predicted improvements in measures of memory and executive function.MethodsWe examined 60 adults aged 60 years and older, who took part in a 12‐week trial of escitalopram versus placebo for generalized anxiety disorder. All subjects had pre‐treatment and post‐treatment assessments that included monitoring of peak and total daily cortisol and a comprehensive neuropsychological evaluation.ResultsSalivary cortisol changes during treatment showed significant associations with changes in immediate and delayed memory but no association with executive tasks (measures of working memory and set shifting). Analyses suggested that a decrease in cortisol due to serotonin‐reuptake inhibitor treatment was responsible for the memory changes: memory improvement was seen with cortisol reduction among patients receiving escitalopram but not among patients receiving placebo.ConclusionSerotonin‐reuptake inhibitor‐induced alteration in circulating cortisol during treatment of generalized anxiety disorder predicted changes in immediate and delayed memory. This finding suggests a novel treatment strategy in late‐life anxiety disorders: targeting hypothalamic–pituitary– adrenal axis dysfunction to improve memory. Copyright © 2011 John Wiley & Sons, Ltd.

Objectives For millions of disabled older adults each year, postacute care in skilled nursing facilities is a brief window of opportunity to regain enough function to return home and live independently. Too often this goal is not achieved, possibly because of therapy that is inadequately intense or engaging. This study tested Enhanced Medical Rehabilitation, an intervention designed to increase patient engagement in, and intensity of, daily physical and occupational therapy sessions in postacute-care rehabilitation. Design Randomized controlled trial of Enhanced Medical Rehabilitation versus standard-of-care rehabilitation. Setting Postacute care unit of a skilled nursing facility in St Louis, MO. Participants Twenty-six older adults admitted from a hospital for postacute rehabilitation. Intervention Based on models of motivation and behavior change, Enhanced Medical Rehabilitation is a set of behavioral skills for physical and occupational therapists that increase patient engagement and intensity, with the goal of improving functional outcome, through (1) a patient-directed, interactive approach, (2) increased rehabilitation intensity, and (3) frequent feedback to patients on their effort and progress. Measurements Therapy intensity: assessment of patient active time in therapy sessions. Therapy engagement: Rehabilitation Participation Scale. Functional and performance outcomes: Barthel Index, gait speed, and 6-minute walk. Results Participants randomized to Enhanced Medical Rehabilitation had higher intensity therapy and were more engaged in their rehabilitation sessions; they had more improvement in gait speed (improving from 0.08 to 0.38 m/s versus 0.08 to 0.22 in standard of care, P = .003) and 6-minute walk (from 73 to 266 feet versus 40 to 94 feet in standard of care, P = .026), with a trend for better improvement of Barthel Index (+43 points versus 26 points in standard of care, P = .087), compared with participants randomized to standard-of-care rehabilitation. Conclusion Higher intensity and patient engagement in the postacute rehabilitation setting is achievable, with resultant better functional outcomes for older adults. Findings should be confirmed in a larger randomized controlled trial.

Older adults are among the most vulnerable to adverse cognitive effects of psychotropic medications and, therefore, the personalization of psychotropic treatment based on adverse drug reactions in this demographic is of great importance. We examined changes on neuropsychological tests of attention attributable to selective serotonin reuptake inhibitor (SSRI) treatment in anxious older adults. We also examined whether variation in serotonin receptor genes was associated with reduced attentional performance with SSRIs. We examined change from pre- to post-treatment in two attention measures - digit span and coding - in 133 adults aged ≥60 yr with generalized anxiety disorder in a 12-wk trial of escitalopram vs. placebo. We also examined attentional change in relation to genetic variability in four central serotonin receptors: the serotonin transporter and serotonin 1A, 2A and 1B receptors. Digit span scores were significantly lowered in patients receiving escitalopram relative to placebo, indicating reduced attentional performance attributable to the SSRI. Individuals with high-transcription variants in the receptors 5-HTR2A rs6311 and 5-HTR1B rs11568817 had greater reductions in attention with SSRI treatment compared to placebo. We conclude that SSRIs reduce attention in older adults, particularly in those with high-expression genetic variants at the serotonin 2A and 1B receptors. Analysing neuropsychological changes with SSRIs in relation to genetic variation in the serotonin system may be a useful strategy for detecting subgroups of older adults who are more susceptible to side-effects of SSRIs. These results, if confirmed, could lead to the personalization of SSRI use to reduce adverse neurocognitive effects.

Highly structured interviews were conducted with 792 adolescents, ages 14 to 18, from St. Louis, Missouri, who received services from gateway sectors (child welfare, education, juvenile justice, and primary health care). These youths were exposed to high rates of violence in their families, neighborhoods, and schools, all of which were associated with suicidality and symptoms of major mental health disorders (i.e., depression, conduct disorder, substance abuse or dependence, and post-traumatic stress). Multivariate analyses demonstrated that personal victimization was associated with each of the assessed mental health problems. Further, intrafamilial violence was a significant predictor of all problems except for suicidality. Witnessing a violent act was associated with all the externalizing problems, as well as with depression and posttraumatic stress symptoms. Participation in structured activities moderated the relationships between intrafamilial violence and each of the externalizing problems.

Despite clinical reports of other withdrawal-like symptoms, the DSM-IV considers only restlessness/irritability as a withdrawal-like criterion comprising pathological gambling disorder (PGD). We explored whether this criterion should be broadened to include other gambling withdrawal-like symptoms.Community-recruited adult gamblers (n = 312) participated in telephone interviews about gambling and related behaviors as a part of a larger psychometric study. Frequency and chi-square analyses described the association of gambling withdrawal-like symptoms by gambling disorder status. Multinomial forward selection logistic regression obtained a multivariate model describing the simultaneous relationship between these symptoms and gambling disorder status.One-quarter of the sample experienced the DSM-IV PGD criterion of restlessness/irritability. However, 41% experienced additional gambling withdrawal-like symptoms when attempting to quit or control gambling. A model including restlessness/irritability and three additional non-DSM-IV withdrawal-like symptoms (i.e. feelings of anger, guilt, and disappointment) is a stronger model of gambling disorder (chi(2) = 217.488; df = 8, p < 0.0001; R(2) = 0.5428; p < 0.0001) than restlessness/irritability alone (chi(2) = 151.278; df = 2, p < 0.0001; R(2) = 0.4133). The overlap of gambling withdrawal-like symptoms with substance use withdrawal (11%) and depressive symptoms (34%) failed to fully account for these associations with gambling disorder status.Future PGD conceptualization and potential criteria revisions for DSM-V may warrant a broader inclusion of gambling withdrawal-like symptoms.

This chapter deals exclusively with the practicalities of how to manage data to increase and maintain reliability and accuracy. It focuses primarily on setting up the printed or computerized interview; structuring it to minimize human error; and maximizing movement to a clean, usable, archivable dataset. It covers the continuum of data management, starting with adapting instruments. It presents a budget analysis guide for choosing to use paper or computerized interviews. Examples of correct and incorrect formatting are illustrated. The chapter closes with a discussion of data entry, setting up datasets for longitudinal studies, and data archiving.