Search results - Portal of Medical Data Models (MDM-Portal)

Itemgroups: Early Withdrawal, Vital Signs, Physical Examination, Psychiatric Evaluation, Pharmacokinetic Sampling, Atypical Antipsychotic Dosing, Quality of Life Assessment, Investigational Product Dosing

Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Week 12 - Visit 11 or Early Withdrawal.

Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593 - Baseline Visit

- 4/19/18 - 1 form, 5 itemgroups, 23 items, 1 language

Itemgroups: Vital Signs, Psychiatric Evaluation, Pharmacokinetic Sampling, Atypical Antipsychotic Dosing, Quality of Life Assessment

Metastatic Colorectal Cancer Fluorouracil Leucovorin Irinotecan Oxaliplatin NCT00077233 CALGB 80203 - Quality of Life CES-D

- 7/14/17 - 1 form, 2 itemgroups, 17 items, 1 language

Itemgroups: Administrative Data, Center for Epidemiologic Studies Depression Scale

CALGB: CES-D (SHORT FORM) Colorectal Cancer NCT00077233 Quality of Life - CALGB: CES-D (SHORT FORM) - 2088990v3.0 Fluorouracil and Leucovorin Plus Either Irinotecan or Oxaliplatin With or Without Cetuximab in Treating Patients With Previously Untreated Metastatic Adenocarcinoma of the Colon or Rectum https://clinicaltrials.gov/ct2/show/NCT00077233

Measurement Instrument Database for the Social Science (MIDSS) - Attitude Follow-Up Scale (AFS)

- 9/30/20 - 1 form, 2 itemgroups, 19 items, 1 language

Itemgroups: Instructions, Extent

Stiggelbout, A. M., de Haes, J. C., Vree, R. van de Velde, C. J., Bruijninckx, C. M., van Groningen, K., Kievit, J. (1997). Attitude Follow-Up Scale (AFS). Measurement Instrument Database for the Social Science. Retrieved 30.09.2020, from www.midss.ie Key references: Stiggelbout, A. M., de Haes, J. C., Vree, R. van de Velde, C. J., Bruijninckx, C. M., van Groningen, K., and Kievit, J. (1997). Follow-up of colorectal cancer patients: quality of life and attitudes towards follow-up. Br J Cancer, 75(6), 914–920. Kiebert, G. M., Welvaart, K., Kievit, J. (1993). Psychological effects of routine follow up on cancer patients after surgery. Eur J Surg, 159(11–12), 601–607 Thewes, B., Butow, P., Zachariae, R., Christensen, S., Simard, S & Gotay, C. (2012). Fear of cancer recurrence: a systematic literature review of self-report measures. Psycho-Oncology, 21, 571–587 Primary use / Purpose: The Attitude Follow-Up Scale (AFS) is a 19-item inventory rated on a 4 point Likert-type scale. Its purpose is to measure the attitudes of cancer patients towards follow-up. Patients’ attitudes are measured under four dimensions: communication (with a physician), reassurance, nervous anticipation, and perceived disadvantages of the follow-up process. Background: A substantial amount of research exists on the well-being and quality of life associated with clinical samples, especially those diagnosed with cancer. However, little research has specifically studied the physical and psychological outcomes associated with follow-up procedures between patient and physician. To address this, Stiggelbout, de Haes, & Vree et al. (1997) tweaked an existing scale developed by Kiebert, Welvaart, Kievit (1993) and ended up with the Attitude Follow-Up Scale (AFS). Psychometrics: The psychometric properties of the Attitude Follow-Up Scale (AFS) are discussed in Stiggelbout, de Haes, & Vree et al. (1997). Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.324

Measurement Instrument Database for the Social Science (MIDSS) - The Silver Lining Questionnaire

- 7/23/20 - 1 form, 2 itemgroups, 41 items, 1 language

Itemgroups: General Information, The Silver Lining Questionnaire

Sodergren, S. C., Hyland, M. E.. (1997). The Silver Lining Questionnaire. Measurement Instrument Database for the Social Science. Retrieved 22.07.2020, from www.midss.ie Key references: 1. Sodergren, S. C. & Hyland, M. E. (1997). Qualitative phase in the development of the Silver Lining Questionnaire. Quality of Life Research, 6, (7-8), 365. 2. Sodergren, S. C., & Hyland, M. E. (2000). What are the positive consequences of illness? Psychology and Health, 15, 85-97. 3. Sodergren, S. C., Hyland, M. E., Singh, S. J., & Sewell, L. (2002). The effect of rehabilitation on positive interpretations of illness. Psychology and Health; 17, 753-760. 4. Sodergren, S. C., Hyland, M. E., Crawford, A., Partridge, M. R. (2004). Positivitiy in illness: self-delusion or existential growth? British Journal of Health Psychology, 9, 163-174. 5. Hyland, M. E., Sodergren, S. C., & Lewith, G. T. (in press). The role of positivity in chronic fatigue syndrome (CFS). Journal of Health Psychology. Primary use / Purpose: The Silver Lining Questionnaire measures the extent to which people believe their illness has had a positive benefit despite the negative consequences of being ill. Research suggests that this positive interpretation is not due to a form of self-delusion but instead reflects personal growth and that it can be enhanced by the context. Its role in recovery from illness is complex. Web link to tool: The Silver Lining Questionnaire Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.78

Measurement Instrument Database for the Social Science (MIDSS) - The Satisfaction with Life Scale (SWL)

- 5/3/20 - 1 form, 1 itemgroup, 5 items, 1 language

Itemgroup: Statements

Pavot, W., & Diener, E.. (2013). The Satisfaction with Life Scale (SWL). Measurement Instrument Database for the Social Science. Retrieved [03.05.2020], from www.midss.ie Author of Tool: Pavot, W., & Diener, E. Key references: Diener, E., Emmons, R. A., Larsen, R. J., & Griffin, S. (1985). The Satisfaction with Life Scale. Journal of Personality Assessment, 49, 71-75. Pavot, W. G., Diener, E., Colvin, C. R., & Sandvik, E. (1991). Further validation of the Satisfaction with Life Scale: Evidence for the cross-method convergence of well-being measures. Journal of Personality Assessment, 57, 149-161. Pavot, W., & Diener, E. (1993). Review of the Satisfaction with Life Scale. Psychological Assessment, 5, 164-172. Pavot, W., & Diener, E. (2008). The Satisfaction With Life Scale and the emerging construct of life satisfaction. ournal of Positive Psychology, 3, 137–152 Primary use / Purpose: The SWLS is a short 5-item instrument designed to measure global cognitive judgments of satisfaction with one's life. Background: The Satisfaction With Life Scale (SWLS) has been used heavily as a measure of the life satisfaction component of subjective well-being. Scores on the SWLS have been shown to correlate with measures of mental health, and be predictive of future behaviours such as suicide attempts. In the area of health psychology, the SWLS has been used to measure the subjective quality of life of people experiencing serious health concerns. Psychometrics: The SWLS is a 7-point Likert style response scale. The possible range of scores is 5-35, with a score of 20 representing a neutral point on the scale. Scores between 5-9 indicate the respondent is extremely dissatisfied with life, whereas scores between 31-35 indicate the respondent is extremely satisfied. The coefficient alpha for the scale has ranged from .79 to .89, indicating that the scale has high internal consistency. The scale was also found to have good test-retest correlations (.84, .80 over a month interval). For a detailed psychometric description of the SWLS see: Pavot, W., & Diener, E. (2008). The Satisfaction With Life Scale and the emerging construct of life satisfaction. ournal of Positive Psychology, 3, 137–152. Keywords: Quality of Life Web link to tool: http://internal.psychology.illinois.edu/~ediener/SWLS.html Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.467 Evaluation: 31 - 35 Extremely satisfied 26 - 30 Satisfied 21 - 25 Slightly satisfied 20 Neutral 15 - 19 Slightly dissatisfied 10 - 14 Dissatisfied 5 - 9 Extremely dissatisfied Understanding Scores on the Satisfaction with Life Scale (by Ed Diener) (Note: If we divide by the number of questions, rather than use the summed aggregate score, then the cutoffs below instead should be: 6-7 5-6 4-5 3-4 2-3 1-2 30 – 35 Very high score; highly satisfied Respondents who score in this range love their lives and feel that things are going very well. Their lives are not perfect, but they feel that things are about as good as lives get. Furthermore, just because the person is satisfied does not mean she or he is complacent. In fact, growth and challenge might be part of the reason the respondent is satisfied. For most people in this high-scoring range, life is enjoyable, and the major domains of life are going well – work or school, family, friends, leisure, and personal development. 25- 29 High score Individuals who score in this range like their lives and feel that things are going well. Of course their lives are not perfect, but they feel that things are mostly good. Furthermore, just because the person is satisfied does not mean she or he is complacent. In fact, growth and challenge might be part of the reason the respondent is satisfied. For most people in this high-scoring range, life is enjoyable, and the major domains of life are going well – work or school, family, friends, leisure, and personal development. The person may draw motivation from the areas of dissatisfaction. 20 – 24 Average score The average of life satisfaction in economically developed nations is in this range – the majority of people are generally satisfied, but have some areas where they very much would like some improvement. Some individuals score in this range because they are mostly satisfied with most areas of their lives but see the need for some improvement in each area. Other respondents score in this range because they are satisfied with most domains of their lives, but have one or two areas where they would like to see large improvements. A person scoring in this range is normal in that they have areas of their lives that need improvement. However, an individual in this range would usually like to move to a higher level by making some life changes. 15 – 19 Slightly below average in life satisfaction People who score in this range usually have small but significant problems in several areas of their lives, or have many areas that are doing fine but one area that represents a substantial problem for them. If a person has moved temporarily into this level of life satisfaction from a higher level because of some recent event, things will usually improve over time and satisfaction will generally move back up. On the other hand, if a person is chronically slightly dissatisfied with many areas of life, some changes might be in order. Sometimes the person is simply expecting too much, and sometimes life changes are needed. Thus, although temporary dissatisfaction is common and normal, a chronic level of dissatisfaction across a number of areas of life calls for reflection. Some people can gain motivation from a small level of dissatisfaction, but often dissatisfaction across a number of life domains is a distraction, and unpleasant as well. 10 – 14 Dissatisfied Peole who score in this range are substantially dissatisfied with their lives. People in this range may have a number of domains that are not going well, or one or two domains that are going very badly. If life dissatisfaction is a response to a recent event such as bereavement, divorce, or a significant problem at work, the person will probably return over time to his or her former level of higher satisfaction. However, if low levels of life satisfaction have been chronic for the person, some changes are in order – both in attitudes and patterns of thinking, and probably in life activities as well. Low levels of life satisfaction in this range, if they persist, can indicate that things are going badly and life alterations are needed. Furthermore, a person with low life satisfaction in this range is sometimes not functioning well because their unhappiness serves as a distraction. Talking to a friend, member of the clergy, counselor, or other specialist can often help the person get moving in the right direction, although positive change will be up the person. 5 – 9 Extremely Dissatisfied Individuals who score in this range are usually extremely unhappy with their current life. In some cases this is in reaction to some recent bad event such as widowhood or unemployment. In other cases, it is a response to a chronic problem such as alcoholism or addiction. In yet other cases the extreme dissatisfaction is a reaction due to something bad in life such as recently having lost a loved one. However, dissatisfaction at this level is often due to dissatisfaction in multiple areas of life. Whatever the reason for the low level of life satisfaction, it may be that the help of others are needed – a friend or family member, counseling with a member of the clergy, or help from a psychologist or other counselor. If the dissatisfaction is chronic, the person needs to change, and often others can help. Part that is common to each category To understand life satisfaction scores, it is helpful to understand some of the components that go into most people’s experience of satisfaction. One of the most important influences on happiness is social relationships. People who score high on life satisfaction tend to have close and supportive family and friends, whereas those who do not have close friends and family are more likely to be dissatisfied. Of course the loss of a close friend or family member can cause dissatisfaction with life, and it may take quite a time for the person to bounce back from the loss. Another factor that influences the life satisfaction of most people is work or school, or performance in an important role such as homemaker or grandparent. When the person enjoys his or her work, whether it is paid or unpaid work, and feels that it is meaningful and important, this contributes to life satisfaction. When work is going poorly because of bad circumstances or a poor fit with the person’s strengths, this can lower life satisfaction. When a person has important goals, and is failing to make adequate progress toward them, this too can lead to life dissatisfaction. A third factor that influences the life satisfaction of most people is personal – satisfaction with the self, religious or spiritual life, learning and growth, and leisure. For many people these are sources of satisfaction. However, when these sources of personal worth are frustrated, they can be powerful sources of dissatisfaction. Of course there are additional sources of satisfaction and dissatisfaction – some that are common to most people such as health, and others that are unique to each individual. Most people know the factors that lead to their satisfaction or dissatisfaction, although a person’s temperament – a general tendency to be happy or unhappy – can color their responses. There is no one key to life satisfaction, but rather a recipe that includes a number of ingredients. With time and persistent work, people’s life satisfaction usually goes up when they are dissatisfied. People who have had a loss recover over time. People who have a dissatisfying relationship or work often make changes over time that will increase their dissatisfaction. One key ingredient to happiness, as mentioned above, is social relationships, and another key ingredient is to have important goals that derive from one’s values, and to make progress toward those goals. For many people it is important to feel a connection to something larger than oneself. When a person tends to be chronically dissatisfied, they should look within themselves and ask whether they need to develop more positive attitudes to life and the world. Copyright by Ed Diener, February 13, 2006 Use is free of charge and granted by permission.

Quality of Life as Affected by Respiratory Disease Protocol PhenX Toolkit

- 4/29/16 - 1 form, 1 itemgroup, 47 items, 1 language

Itemgroup: PhenX - respiratory - quality of life protocol

Self-administered questionnaire contains 50 items and 76 weighted responses divided into three components: Symptoms (frequency and severity); Activity (activities that cause or are limited by breathlessness); and Impacts (social unctioning, psychological disturbances resulting from airways disease). The protocol is designed to measure health impairment in patients with asthma and chronic obstructive pulmonary disease (COPD). It is also valid for use in bronchiectasis and has been used successfully in patients with kyphoscoliosis and sarcoidosis. ODM derived from: https://cde.nlm.nih.gov Primary source: https://www.phenxtoolkit.org/ Recent publication: Hendershot, T., Pan, H., Haines, J., Harlan, W.R., Marazita, M.L., McCarty, C.A., Ramos, E.M., and Hamilton, C.M. (2015) Using the PhenX toolkit to add standard measures to a study. Curr. Protoc. Hum. Genet. 86:1.21.1-1.21.17. doi: 10.1002/0471142905.hg0121s86 Permission to publish granted by Carol M. Hamilton.

Distress Thermometer - NCCN Distress Thermometer

- 4/17/15 - 1 form, 6 itemgroups, 36 items, 2 languages

Itemgroups: Distress Thermometer, Practical problems, Family problems, Emotional problems, Spiritual/religious concerns, Physical problems

Copyright National Comprehensive Cancer Network German Version: Anja Mehnert, Diana Müller, Claudia Lehmann und Uwe Koch. Die deutsche Versiondes NCCN Distress-Thermometers. Empirische Prüfung eines Screening-Instruments zur Erfassung psychosozialer Belastung bei Krebspatienten. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie, 54 (3), 2006, 213–223

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