The Baby Steps online program for wellbeing of new parents: A randomized controlled trial (Preprint)

2020 ◽  
Author(s):  
David John Kavanagh ◽  
Jennifer Connolly ◽  
Jane Fisher ◽  
Kim Halford ◽  
Kyra Hamilton ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Depression Scale ◽  
Full Time ◽  
Support Provision ◽  
Intention To Treat ◽  
Time Interaction ◽  
Secondary Outcomes

BACKGROUND New mothers and fathers face increased risks of emotional distress and relationship dissatisfaction. Digital interventions may increase access to support, but few preventive programs are optimised to support both parents. OBJECTIVE To conduct the first randomised controlled trial on a universal self-guided digital program to support positive perinatal adjustment of both fathers and mothers. Effects of childcare information modules only (Babycare) and the full interactive program (Baby Steps Wellbeing) were compared from Baseline in the third trimester to 3 and 6 months later (approximately 1 and 4 months postpartum). METHODS Participants were co-parenting, male-female adult couples expecting their first single child (26-38 weeks’ gestation, 87% from hospital antenatal classes). Randomisation to condition was stratified by Edinburgh Postnatal Depression Scale scores (EPDS; either mother > 7 or father > 5, giving 50% of couples scoring ‘higher’). Primary outcomes were self-reported EPDS and quality of life; secondary outcomes were relationship satisfaction, social support, and self-efficacy for parenting and support provision. Program use and satisfaction were also assessed. Intention-to-treat analyses used linear mixed models. RESULTS Of 388 couples who registered, 248 (64%) met criteria and were randomised. Most were married (81%), tertiary educated (65%), in full-time employment (82%) and born in Australia (68%). Participants’ mean age was 32 years and average gestation was 32 weeks. Using an EPDS cut-off of 12/13, only 4% of men and 6% of women screened positive for probable depression at Baseline (7% and 16% at some time during the 6 months). Retention of both partners to 6-month-assessments was 81%, and program satisfaction was excellent (92% > 50, M = 73/100), regardless of condition. Regardless of condition, only 37-38% of participants accessed their program more than once, with higher rates for mothers (54%) than fathers (21%, P < .001). Changes over Time were seen for EPDS (P = .002, d = .093) and quality of life (P < .001, d = 271). These effects were moderated by sex (P <= .001): fathers appeared to improve linearly; mothers had reduced 3-month-scores that improved by 6 months. Neither outcome showed a Condition x Time interaction (P = .430, .640 respectively). Among secondary outcomes, only self-efficacy for support provision showed greater improvements in Baby Steps Wellbeing (d = .337) than Babycare (d = .093; P = .01)—an effect that was greater for mothers (P = .027). Supplementary analyses examining effects of above/below median Baseline EPDS and of at least one program login did not substantially change results. CONCLUSIONS Despite high levels of satisfaction and retention to assessment, program engagement was limited, and only one outcome showed evidence of enhanced effects from the interactive Wellbeing program. Increased engagement in program use and action plans is needed, especially for men. CLINICALTRIAL Australian & New Zealand Clinical Trials Registry NZCTR12614001256662

scholarly journals Task-oriented exercises improve disability of working patients with surgically-treated proximal humeral fractures. A randomized controlled trial with one-year follow-up

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marco Monticone ◽  
Igor Portoghese ◽  
Daniele Cazzaniga ◽  
Valentina Liquori ◽  
Giuseppe Marongiu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Group Differences ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
One Year ◽  
Task Oriented

Abstract Background General physiotherapy is a common means of rehabilitation after surgery for proximal humeral fracture (PHF). Better-targeted exercises seem worthy of investigation and the aim of this study was to assess the efficacy of a rehabilitation program including task-oriented exercises in improving disability, pain, and quality of life in patients after a PHF. Methods By means of a randomized controlled trial with one-year follow-up, 70 working patients (mean age of 49 ± 11 years; 41 females), who were selected for open reduction and internal fixation with plates caused by PHF, were randomized to be included in an experimental (n = 35) or control group (n = 35). There was a permuted-block randomization plan, and a list of program codes was previously created; subsequently, an automatic assignment system was used to conceal the allocation. The first group underwent a supervised rehabilitation program of task-oriented exercises based on patients’ specific job activities, and occupational therapy. The second group underwent general physiotherapy, including supervised mobility, strengthening and stretching exercises. Both groups individually followed programs of 60-min session three times per week for 12 weeks in the outpatient setting. The Disability Arm Shoulder Hand questionnaire (DASH; scores range from 0 to 100; primary outcome), a Pain intensity Numerical Rating Scale (scores range 0 to 10; secondary outcomes), and the Short-Form Health Survey (scores range from 0 to 100; secondary outcomes) assessed the interventions. Participants were evaluated before surgery, before and after rehabilitation (primary endpoint), and at the one-year follow-up (secondary endpoint). A linear mixed model analysis for repeated measures was carried out for each outcome measure (p < 0.05). Results Time, group and time by group showed significant effects for all outcome measures in favour of the experimental group. The DASH and the DASH work achieved clinically important between-group differences of 16.0 points (95% confidence interval [C.I.] 7.3 to 24.7) and 19.7 (95% C.I. 9.0 to 30.5) at follow-up, respectively. The NRS achieved a between-group difference of 2.9 (95% C.I. 1.0 to 3.9) at follow-up. As for SF-36, there were between-group differences ranging from 17.9 to 37.0 at follow-up. Conclusions A rehabilitation program based on task-oriented exercises was useful in improving disability, pain, and quality of life in working patients after PHFs. Improvements lasted for at least 12 months. Trial registration On 16/12/2019, the trial was retrospectively registered in the ISRCTN registry with the ID number 17996552.

Challenges of Telemonitoring Programs for Complex Chronic Conditions: A Randomized Controlled Trial with an Embedded Qualitative Study (Preprint)

2021 ◽  
Author(s):  
Patrick Ware ◽  
Amika Shah ◽  
Heather Joan Ross ◽  
Alexander Gordon Logan ◽  
Phillip Segal ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Decision Support ◽  
Chronic Conditions ◽  
Controlled Trial ◽  
Self Care ◽  
Randomized Controlled ◽  
Complex Patients ◽  
Secondary Outcomes

BACKGROUND Despite the growing prevalence of people with complex conditions and evidence of the positive impact of telemonitoring for single conditions, little research exists on the use of telemonitoring in this population, particularly those with multiple chronic conditions (MCCs). OBJECTIVE This randomized controlled trial (RCT) and embedded qualitative study aimed to evaluate the impact and experiences of patients and healthcare providers (HCPs) using a telemonitoring system with decision support to manage complex patients, including those with MCCs, compared to the standard of care. METHODS A pragmatic 6-month RCT sought to recruit 146 patients with a diagnosis of heart failure (HF), uncontrolled hypertension (HT), and/or insulin requiring diabetes (DM) from outpatient specialty settings in Toronto, Canada. Participants were randomized into the control and telemonitoring groups with the latter being instructed to take readings relevant to their condition(s). The telemonitoring system contained an algorithm that generated decision support in the form of actionable self-care directives to patients and alerts to HCPs. The primary outcome was health status as measured by the SF-36. Secondary outcomes included anxiety and depression, self-efficacy in chronic disease management, and self-reported healthcare utilization. HF-related quality of life and self-care measures were also collected from patients followed for HF. Within- and between-group change scores were analyzed for statistical significance (P<.05). A convenience sample of HCPs and patients in the intervention group were interviewed about their experiences RESULTS A total of 96 patients were recruited and randomized. Recruitment was terminated early due to implementation challenges and the onset of COVID-19. No significant within- and between-group differences were found for the main primary and secondary outcomes. However, a within-group analysis of HF patients found improvements in self-care maintenance (P=.036) and physical quality of life (P= .046). Opinions expressed by the 5 HCPs and 13 patients interviewed differed based on the condition(s) monitored. Although HF patients reported benefitting from actionable self-care guidance and meaningful interactions with their HCPs, patient and HCP users of the DM and HT modules did not think telemonitoring improved the clinical management of those conditions to the same degree. These differing experiences were largely attributed to the siloed nature of specialty care, and the design of the decision support whereby it was indicated that fluctuations in HT and DM patient status typically required less urgent intervention compared to HF. CONCLUSIONS Consistent with previous studies, we recommend that future research conceive telemonitoring as a program and that self-management and clinical decision support are necessary, but not sufficient components of such programs for complex patients with lower acuity. We conclude that a multidisciplinary model of care that includes care coordination must accompany telemonitoring systems which may best be operationalized through novel models of care, such as nurse-led models. CLINICALTRIAL ClinicalTrials.gov NCT03127852, ISRCTN (41238563) INTERNATIONAL REGISTERED REPORT RR2-10.2196/resprot.8367

scholarly journals “VelaMente?!” - Sailin in a Crew to Improve Self-Efficacy in People with Psychosocial Disabilities: A Randomized Controlled Trial

2017 ◽  
Vol 13 (1) ◽  
pp. 200-212 ◽  
Author(s):  
Federica Sancassiani ◽  
Alessio Cocco ◽  
Giulia Cossu ◽  
Stefano Lorrai ◽  
Giuseppina Trincas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Sense Of Coherence ◽  
Self Efficacy ◽  
Longitudinal Research ◽  
Short Form ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Waiting List ◽  
Treatment As Usual

Introduction:It has been proposed that sailing can improve quality of life, personal and social skills of people with severe psychosocial disabilities. This study aimed to assess the efficacy of a psychosocial rehabilitative intervention focused on sailing on quality of life, self-efficacy and sense of coherence in people with severe psychosocial disabilities.Methods:The study was a randomized, with parallel groups, waiting-list controlled trial. Participants were 51 people with severe psychosocial disabilities. The intervention was a structured course to learn sailing in a crew lasting three months. A randomized group began the sailing course immediately after a pre-treatment assessment; the waitlist group began the sailing course after a three months period of treatments as usual. Participants were assessed before and after the sailing course, or the waiting list period, on the General Self-Efficacy scale (GSES), Sense Of Coherence scale (SOC) and Health Survey-short form (SF-12).Results:Self-efficacy significantly increased after the sailing course and decreased after treatment as usual (p=0.015). Sense of coherence and the levels of quality of life tended to improve after the sailing course, albeit below levels of statistical significance.Conclusion:When compared to more traditional psychosocial rehabilitative activities, an intervention focused on sailing in a crew positively impacts the sense of coherence and the levels of quality of life and significantly improves self-efficacy of people with severe psychosocial disabilities. Further longitudinal research is required.

Efficacy of task-specific circuit training on physical activity levels and mobility of stroke patients: A randomized controlled trial

2020 ◽  
Vol 47 (4) ◽  
pp. 451-462
Author(s):  
Júlia Caetano Martins ◽  
Sylvie Nadeau ◽  
Larissa Tavares Aguiar ◽  
Aline Alvim Scianni ◽  
Luci Fuscaldi Teixeira-Salmela ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Experimental Group

BACKGROUND: Impaired mobility is related to low physical activity (PA) levels observed after stroke. Therapeutic approaches, such as task-specific circuit training (TSCT), used to improve mobility in individuals with stroke, could also improve PA levels. OBJECTIVE: To investigate the efficacy of TSCT, focused on both upper (UL) and lower (LL) limbs, in improving PA levels and mobility (primary outcomes), as well as muscle strength, exercise capacity, and quality of life (secondary outcomes) in subjects with stroke. METHODS: A randomized controlled trial with 36 subjects with chronic stroke was conducted. Experimental group: TSCT, involving both UL and LL. Control group: global stretching, memory exercises, and education sessions. Both groups received 60 minute sessions/week over 12 weeks. Outcomes were measured at baseline, post-intervention and 16 week follow-up. RESULTS: No changes were found for primary and secondary outcomes (0.11≤p≤0.99), except for quality of life, which improved in the experimental group post-intervention and 16 week follow-up (p = 0.02). CONCLUSION: TSCT focused on both UL and LL was not effective on PA levels and mobility of individuals with chronic stroke, however, improvements in quality of life were observed. Since this is the first study to investigate this combined training aimed at improving PA levels, future studies are necessary to better understand the impact of this type of intervention.

A placebo-controlled trial of Sertraline's effects on symptoms, well-being and survival in advanced cancer: The ZEST Trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9002-9002 ◽  
Author(s):  
N. R. Wilcken ◽  
D. Goldstein ◽  
A. K. Nowak ◽  
P. J. Beale ◽  
M. Jefford ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Advanced Cancer ◽  
Cox Model ◽  
Controlled Trial ◽  
Depression Scale ◽  
Final Analysis ◽  
Well Being ◽  
Hazard Ratio ◽  
Sensitivity Analyses

9002 Background: Depression, anxiety, fatigue and impaired well-being are common, important and closely related in advanced cancer. We sought to determine the effects of sertraline (a well-tolerated, SSRI antidepressant) on these symptoms and survival in a broad cross-section of people with advanced cancer but without major depression. Methods: 189 participants (pts) were randomly allocated to sertraline 50 mg daily or placebo. Assessments were at baseline; months 1, 2, 4, 6, 9, 12; and, then 3-monthly. Outcome measures rated by pts included the: Centre for Epidemiologic Studies Depression scale (CES-D); Hospital Anxiety and Depression Scale (HADS-A, HADS-D); and the Functional Assessment of Cancer Therapy General and Fatigue scales (FACT-G and FACT-F). Clinicians completed Spitzer's Quality of Life Index (SQLI). Outcomes on all scales are expressed from 0 (worst) to 100 (best). The primary analyses of sertraline's effects on quality of life were based on scores at 4 and 8 weeks adjusted for baseline scores using generalised estimating equations. Efficacy analyses are by intention to treat; toxicity analyses by treatment received. P-values and 95% confidence intervals (CI) are 2-sided. Results: Recruitment was stopped after the first planned interim analysis of 150 pts showed a trend in overall survival favouring placebo (univariable logrank p=0.04; multivariable Cox model hazard ratio 1.61, CI 1.1 to 2.5, p=0.02). This trend was weaker at the final analysis including all 189 patients and longer follow-up (univariable logrank p=0.09); and, after accounting for baseline factors (multivariable Cox model hazard ratio 1.27, CI 0.87 to 1.8, p=0.2). Sertraline had no significant effects (scale: benefit over placebo, 95% CI) on depression (CES-D: 0.4, −2.6 to 3.4), anxiety (HADS-A: 2.0, −1.5 to 5.5), fatigue (FACT-F: 0.3, −4.3 to 4.9), overall quality of life (FACT-G: 1.7, −1.3 to 4.7) or clinicians’ ratings (SQLI: 2.0, −2.5 to 6.5). Subgroup and sensitivity analyses also excluded significant benefits. Sertraline was discontinued more often and earlier than placebo (logrank p = 0.03). The trial was closed for lack of benefit. Conclusions: Sertraline did not improve symptoms, well-being or survival and should be reserved for those with a proven indication. No significant financial relationships to disclose.

scholarly journals The effect of graded activity and pain education (GAPE) - an early post-surgical rehabilitation programme after lumbar spinal fusion: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Heidi Tegner ◽  
Bente Appel Esbensen ◽  
Marius Henriksen ◽  
Rachid Bech-Azeddine ◽  
Mari Lundberg ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Usual Care ◽  
Sedentary Behaviour ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Physically Active ◽  
Fear Of Movement ◽  
Post Surgery ◽  
Lumbar Spinal

Abstract BackgroundPatients with chronic low back pain undergoing lumbar spinal fusion (LSF) are physically inactive and thereby at risk of poor health. Barriers to being physically active need to be acknowledged in post-surgical rehabilitation. The primary objective of this randomized controlled trial (RCT) is to examine the effect of an early active intervention consisting of graded activity and pain education (GAPE) on sedentary behaviour in a population of patients undergoing LSF. The secondary objectives are to examine the effect of GAPE on, respectively, disability, pain, fear of movement, self-efficacy for exercise and health-related quality of life.MethodsThe study is an RCT planned to include 144 patients undergoing LSF at 1-2 levels for low back pain caused by degeneration of the lumbar spine. The patients will be randomly assigned to receive either usual care or usual care plus GAPE. GAPE consists of nine individual physiotherapist-guided sessions over a 10-week period. The overall purpose is to reduce sedentary behaviour, by educating the patient about pain and, based on a cognitive behavioural perspective, gradually strengthen the patient’s self-efficacy to be physically active and reduce fear of movement. The physiotherapist will plan the intervention in collaboration with the patient. Based on a semi-structured interview and observations of the patient in their home, they will set individually functional goals. The primary outcome will be reduction in sedentary behaviour, measured by an accelerometer at baseline (pre-surgery), and at three and 12 months post-surgery. Secondary outcomes will include disability, pain, fear of movement, self-efficacy for exercise, and quality of life. Secondary outcome data will be collected at baseline (pre-surgery), and at three, six, and 12 months post-surgery. DiscussionWe hypothesize that, compared with the “usual care group”, GAPE will primarily lead to a significantly reduction in sedentary behaviour, and secondarily a reduction in disability, pain intensity, and fear of movement; further, it will increase the patient’s self-efficacy for exercise and quality of life. Trial registration: www.clinicaltrials.gov (NCT04103970), 24 September 2019

scholarly journals The effect of graded activity and pain education (GAPE): an early post-surgical rehabilitation programme after lumbar spinal fusion—study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Heidi Tegner ◽  
Bente Appel Esbensen ◽  
Marius Henriksen ◽  
Rachid Bech-Azeddine ◽  
Mari Lundberg ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Usual Care ◽  
Sedentary Behaviour ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Physically Active ◽  
Fear Of Movement ◽  
Post Surgery ◽  
Lumbar Spinal

Abstract Background Patients with chronic low back pain undergoing lumbar spinal fusion (LSF) are physically inactive and thereby at risk of poor health. Barriers to being physically active need to be acknowledged in post-surgical rehabilitation. The primary objective of this randomized controlled trial (RCT) is to examine the effect of an early active intervention consisting of graded activity and pain education (GAPE) on sedentary behaviour in a population of patients undergoing LSF. The secondary objective is to examine the effect of GAPE on disability, pain, fear of movement, self-efficacy for exercise, and health-related quality of life. Methods The study is an RCT planned to include 144 patients undergoing LSF at 1–2 levels for low back pain caused by degeneration of the lumbar spine. The patients will be randomly assigned to receive either usual care or usual care plus GAPE. GAPE consists of nine individual physiotherapist-guided sessions over a 10-week period. The overall purpose is to reduce sedentary behaviour, by educating the patient about pain and, based on a cognitive behavioural perspective, gradually strengthen the patient’s self-efficacy to be physically active and reduce fear of movement. The physiotherapist will plan the intervention in collaboration with the patient. Based on a semi-structured interview and observations of the patient in their home, they will set individually functional goals. The primary outcome will be a reduction in sedentary behaviour, measured by an accelerometer at baseline (pre-surgery) and at 3 and 12 months post-surgery. Secondary outcomes will include disability, pain, fear of movement, self-efficacy for exercise, and quality of life. Secondary outcome data will be collected at baseline (pre-surgery) and at 3, 6 and 12 months post-surgery. Discussion We hypothesize that, compared with the “usual care group”, GAPE will primarily lead to a significant reduction in sedentary behaviour, and secondarily a reduction in disability, pain intensity, and fear of movement; further, it will increase the patient’s self-efficacy for exercise and quality of life. Trial registration www.clinicaltrials.gov NCT04103970, Registered on 24 September 2019

The Effect of Educational Program on Pain Management, Self-Efficacy Behavior, and Quality of Life among Adult Diabetic Patients with Peripheral Neuropathy Pain: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Jawad Ahmad Abu-Shennar ◽  
Nurhan Bayraktar
Keyword(s):  
Quality Of Life ◽  
Pain Management ◽  
Educational Intervention ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Experimental Group ◽  
Diabetic Care

Abstract Objective Jordan has a high prevalence of painful diabetic peripheral neuropathy (PDPN), leg complications, and amputations due to diabetes. This study evaluated the effect of educational programs on pain management, self-efficacy behaviors, and quality of life (QoL) among adult patients with PDPN. Methods The randomized controlled trial study was conducted at the Jordanian Ministry of Health hospitals between October 2019 – March 2020. Seventy-two adult patients with PDPN were randomized to an experimental group of 36 patients who attended an educational program and a control group who followed routine diabetic care in the study setting. The data were collected using a socio-demographic and diabetes clinical/laboratory data form, the numeric rating scale (NRS), diabetes self-efficacy scale (DSES), and the quality-of-life questionnaire (EQ-5D). The intervention program consisted of four educational sessions at weekly intervals. Pre-test and post-test evaluations were conducted. Results After the educational intervention, the mean scores of the NRS (p=0.020), DSES (p<0.001), and EQ-5D (p<0.001) in the experimental group improved significantly improved compared to those in the control group. Additionally, while there were no significant correlations between the three study outcomes in the pre-test stage, correlations were observed to be significant after the educational intervention. Conclusion This study shows that the design and implementation of educational intervention combined with routine diabetic care facilitate effective pain management, self-efficacy behaviors, and QoL of patients with PDPN. The health care providers are recommended to use the educational programs for such patients at various levels of services in both health centers and diabetes clinics.

scholarly journals Managing Neuropsychological Impairment in Multiple Sclerosis

2015 ◽  
Vol 17 (3) ◽  
pp. 130-137 ◽  
Author(s):  
Jana Pöttgen ◽  
Stephanie Lau ◽  
Iris Penner ◽  
Christoph Heesen ◽  
Steffen Moritz
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Self Efficacy ◽  
Group Intervention ◽  
Neuropsychological Functioning ◽  
Controlled Trial ◽  
Life Questionnaire ◽  
Framework Analysis ◽  
Psychosocial Burden

Background: Multiple sclerosis (MS) is an inflammatory and neurodegenerative disease of the central nervous system of potential autoimmune origin that is frequently associated with psychological disorders and cognitive deficits, as well as with fatigue, stress, and psychosocial burden. These factors often cause decreased quality of life, social withdrawal, and unemployment. We describe the development of a cognitive-behavioral group intervention based on the concept of metacognition and evaluation of the feasibility and acceptance of the program as a rehabilitation tool. Methods: Metacognitive Training in MS (MaTiMS) consists of six modules, each 90 minutes in duration. We tested acceptance and design of the program in six focus groups (entire sample, n = 27). Framework analysis of transcripts was used to identify key topics and categories. Program modules were revised in accordance with appropriate recommendations of focus group members. We subsequently evaluated MaTiMS in two groups (n = 5, n = 6) in a rehabilitation center. Neuropsychological functioning as well as coping self-efficacy, depression, stress, perceived cognitive deficit, fatigue, and quality of life were assessed. Acceptance of MaTiMS from the patient perspective was also studied. Results: The modules were highly accepted by patients. Pre-post assessments showed significant improvements in the Coping Self Efficacy Scale (P = .007), the Würzburger Fatigue Inventory for MS Score (P = .028), and the Hamburg Quality of Life Questionnaire in Multiple Sclerosis Mood subscale (P = .046). Conclusions: These preliminary results suggest that MaTiMS represents a feasible psychological group training program that may foster improvements in self-efficacy, fatigue, and mood. The next step will be an evaluation of the program in a randomized controlled trial.

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