Patient and Public Involvement and Engagement in the Development of a Platform Clinical Trial for Parkinson's Disease: An Evaluation Protocol.

Background: Patient and public involvement and engagement (PPIE) in the design of trials is important, as participant experience critically impacts delivery. The Edmond J Safra Accelerating Clinical Trials in PD (EJS ACT-PD) initiative is a UK consortium designing a platform trial for disease modifying therapies in PD. Objective: The integration of PPIE in all aspects of trial design and its evaluation throughout the project. Methods: PwP and care partners were recruited to a PPIE working group (WG) via UK Parkinson's charities, investigator patient groups and participants of a Delphi study on trial design. They are supported by charity representatives, trial delivery experts, researchers and core project team members. PPIE is fully embedded within the consortium's five other WGs and steering group. The group's terms of reference, processes for effective working and PPIE evaluation were co-developed with PPIE contributors. Results: 11 PwP and 4 care partners have supported the PPIE WG and contributed to the development of processes for effective working. A mixed methods research-in-action study is ongoing to evaluate PPIE within the consortium. This includes the Patient Engagement in Research Scale -a quantitative PPIE quality measure; semi-structured interviews -identifying areas for improvement and overall impressions of involvement; process fidelity- recording adherence; project documentation review - identifying impact of PPIE on project outputs. Conclusions: We provide a practical example of PPIE in complex projects. Evaluating feasibility, experiences and impact of PPIE involvement in EJS ACT-PD will inform similar programs on effective strategies. This will help enable future patient-centered research.

Validation of the Thai Version of the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale.

OBJECTIVE: This study aims to validate the Thai translation of the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS). METHODS: The English version was translated into Thai and then back-translated into English. The translated version underwent 2 rounds of cognitive pretesting to assess the ease of comprehension, ease of use and comfort with the scale. Then, it underwent large clinimetric testing. RESULTS: The Thai version was validated in 354 PD patients. The comparative fit index (CFI) for all four parts of the Thai version of the MDS-UPDRS was 0.93 or greater. Exploratory factor analysis identified isolated item differences in factor structure between the Thai and English versions. CONCLUSION: The overall factor structure of the Thai version was consistent with that of the English version based on the high CFIs (all CFI ≥ 0.90). Hence, it can be designated the official Thai version of the MDS-UPDRS.

Evaluating a Media Strategy to Provide Health Messages to Medically Underserved Populations.

For nearly every category of chronic disease, blacks with African American ancestry (AAs) bear a disproportionate disease burden in comparison to their non-Hispanic white (NHW) counterparts. The purpose of this study was to evaluate perceptions of a radio-based health communication strategy, geared towards AA adults and the medically underserved. The radio broadcast, titled "Closing the Gap in Healthcare, Inc. (CGHI)," is delivered by a well-known AA male physician in South Carolina. The mission of CGHI is to decrease health disparities in a four-county area of the South Carolina coastal region, defined as the "Lowcountry," by providing evidence-based health information to a broad community audience via radio broadcast messaging. To evaluate the impact of the CGHI, investigators conducted 12 focus groups (FGs) with community members from the broadcast coverage area to evaluate responses to FG questions based on 11 attributes of effective health communication. Potential FG participants were identified/recruited via a South Carolina-based marketing firm. The FGs conducted in the Sea Islands were culturally and racially homogenous. The investigators developed a FG interview guide. Before each FG started, the informed consent process was administered to each participant. Each two-hour FG was digitally recorded.

Correction to: Formative Research on Knowledge and Preferences for Stool-based Tests compared to Colonoscopy: What Patients and Providers Think.

The original version of this article unfortunately contained a mistake. There is a typo in the coauthor name, it should be Franklin G. Berger.

Formative Research on Knowledge and Preferences for Stool-based Tests compared to Colonoscopy: What Patients and Providers Think.

The rates of colorectal cancer (CRC) screening in the U.S. remain below national targets, so many people at risk are not being screened. The objective of this qualitative research project was to assess patient and provider knowledge and preferences about CRC screening modalities and specifically the use of the fecal immunochemical test (FIT) as a first line screening choice. Nine focus groups were conducted with a medically underserved patient population and qualitative interviews were administered to their medical providers. Thematic analysis was used to synthesize key findings. Both providers and patients thought that the FIT would be a good option for CRC screening both as an individual choice and for an overall program approach. The test is less expensive and therefore more readily available for patients compared to colonoscopy. Overall, there was consensus that the FIT offers a reasonably priced, simple approach to CRC screening which has broad appeal to both providers and patients. Concerns identified by patients and providers included the possibility of false positives with the FIT which could be caused by test contamination or failing to perform the test properly. Patients also described feelings of disgust toward performing the FIT and difficulties in following the instructions. Study findings indicate provider and patient support for using the FIT for CRC screening at both the individual and system-wide levels of implementation. While barriers to the use of the FIT were listed, benefits of using the FIT were perceived as positive motivators to engage previously unscreened and uninsured or under-insured individuals in CRC screening.

Cross-Cultural Differences of the Non-Motor Symptoms Studied by the Traditional Chinese Version of the International Parkinson and Movement Disorder Society- Unified Parkinson's Disease Rating Scale.

BACKGROUND: Given the importance of ethnic differences in the evaluation of various aspects of symptoms in patients with Parkinson's disease (PD), we present the formal procedure for completing the traditional Chinese translation of the International and Parkinson and Movement Disorder Society/UPDRS (MDS-UPDRS) and highlight the discrepancy in nonmotor symptoms (NMS) between patients in Eastern and Western countries. METHODS: A total of 350 native Chinese-speaking PD patients were recruited from multiple hospitals in Eastern countries; they completed the MDS-UPDRS. The translation process was executed and factor analysis was performed to determine the structure of the scale. Chi-squared and t tests were used to compare frequency and severity of PD symptoms between the Chinese-speaking and English-speaking groups (n = 876). RESULTS: NMS and motor symptoms were more severe in the Western population (Part I: t(1205) = 5.36, P < 0.0001; and Part III: t(1205) = 7.64, P < 0.0001); however, the prevalence of cognitive dysfunction and impairments in activities of daily living were more frequent in the Eastern patients. The comparative fit index was 0.93 or greater, and the exploratory factor analysis revealed compatible results between the translated scale and the original version. CONCLUSION: The traditional Chinese version of the MDS-UPDRS can be designated as an official translation of the original scale, and it is now available for use. Moreover, NMS in PD constitute a major issue worldwide, and the pattern of NMS among the Chinese population is more marked in terms of cognition-based symptoms and activities of daily living.

Physician perspectives on colorectal cancer surveillance care in a changing environment.

The purpose of this formative qualitatively driven mixed-methods study was to refine a measurement tool for use in interventions to improve colorectal cancer (CRC) surveillance care. We employed key informant interviews to explore the attitudes, practices, and preferences of four physician specialties. A national survey, literature review, and expert consultation also informed survey development. Cognitive pretesting obtained participant feedback to improve the survey's face and content validity and reliability. Results showed that additional domains were needed to reflect contemporary interdisciplinary trends in survivorship care, evolving practice changes and current health policy. Observed dissonance in specialists' perspectives poses challenges for the development of interventions and psychometrically sound measurement. Implications for future research include need for a flexible care model with enhanced communication and role definitions among clinical specialists, improvements in surveillance at multilevels (patients, providers, and systems), and measurement tools that focus on multispecialty involvement and the changing practice and policy environment.

Handling missing values in the MDS-UPDRS.

This study was undertaken to define the number of missing values permissible to render valid total scores for each Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part. To handle missing values, imputation strategies serve as guidelines to reject an incomplete rating or create a surrogate score. We tested a rigorous, scale-specific, data-based approach to handling missing values for the MDS-UPDRS. From two large MDS-UPDRS datasets, we sequentially deleted item scores, either consistently (same items) or randomly (different items) across all subjects. Lin's Concordance Correlation Coefficient (CCC) compared scores calculated without missing values with prorated scores based on sequentially increasing missing values. The maximal number of missing values retaining a CCC greater than 0.95 determined the threshold for rendering a valid prorated score. A second confirmatory sample was selected from the MDS-UPDRS international translation program. To provide valid part scores applicable across all Hoehn and Yahr (H&Y) stages when the same items are consistently missing, one missing item from Part I, one from Part II, three from Part III, but none from Part IV can be allowed. To provide valid part scores applicable across all H&Y stages when random item entries are missing, one missing item from Part I, two from Part II, seven from Part III, but none from Part IV can be allowed. All cutoff values were confirmed in the validation sample. These analyses are useful for constructing valid surrogate part scores for MDS-UPDRS when missing items fall within the identified threshold and give scientific justification for rejecting partially completed ratings that fall below the threshold.

A Formative Study of Colon Cancer Surveillance Care: Implications for Survivor-Centered Interventions.

Colon cancer is one of the most commonly diagnosed cancers in the United States, and an increasing number of survivors has underscored the need for improved colon cancer surveillance care quality. Post-treatment surveillance includes follow-up care visits and tests as well as psychosocial support and lifestyle counseling. This formative study explored the individual, interpersonal, and organizational-level factors related to adherence to surveillance care guidelines to identify modifiable factors for potential educational intervention strategies. A convenience sample of 22 survivors (12 women and 10 men) from two cancer centers were recruited to participate in focus groups or key informant telephone interviews to explore their experiences with care after completing treatment and complete a brief survey. Content analysis was used to identify themes. Results confirmed that survivors navigated a complex surveillance care schedule and described a strong trust in their health care providers that guided their follow-up care experiences. Participants defined the terms "survivorship" and "follow-up" in a variety of different ways. Individual-level themes critical to survivors' experiences included having a positive attitude, relying on one's faith, and coping with fears. Interpersonal-level themes centered around interactions and communication with family and health care providers in follow-up care. While organizational-level factors were highlighted infrequently, participants rated office reminder systems and communication among their multiple providers as valuable. Educational interventions capitalizing on survivors' connections with their physicians and focusing on preparing survivors for what to expect in the next phase of their cancer experience, could be beneficial at the end of treatment to activate survivors for the transition to the post-treatment period.

Official Japanese Version of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale: validation against the original English version.

BACKGROUND: The Movement Disorder Society (MDS)-sponsored revision of the Unified Parkinson's Disease (PD) Rating Scale (UPDRS) (MDS-UPDRS) has been developed and is now available in English. Part of the overall program includes the establishment of official non-English translations of the MDS-UPDRS. We present the process for completing the official Japanese translation of the MDS-UPDRS with clinimetric testing results. METHODS: In this trial, the MDS-UPDRS was translated into Japanese, underwent cognitive pre-testing, and the translation was modified after taking the results into account. The final translation was approved as Official Working Draft of the MDS-UPDRS Japanese version and tested in 365 native-Japanese-speaking patients with PD. Confirmatory analyses were used to determine whether the factor structure for the English-language MDS-UPDRS could be confirmed in data collected using the Official Working Draft of the Japanese translation. As a secondary analysis, we used exploratory factor analyses to examine the underlying factor structure without the constraint of a pre-specified factor organization. RESULTS: Confirmatory factor analysis revealed that Comparative Fit Index for all Parts of the MDS-UPDRS exceeded the minimal standard of 0.90 relative to the English version and therefore Japanese translation met the pre-specified criterion to be designated called an OFFICIAL MDS TRANSLATION. Secondary analyses revealed some differences between the English-language MDS-UPDRS and the Japanese translation, however, these differences were considered to be within an acceptable range. CONCLUSIONS: The Japanese version of the MDS-UPDRS met the criterion as an Official MDS Translation and is now available for use (www.movementdisorders.org).

Using cognitive pretesting in scale development for Parkinson's disease: the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) example.

BACKGROUND: Cognitive pretesting, a qualitative step in scale development, precedes field testing and assesses the difficulty of instrument completion for examiners and respondents. Cognitive pretesting assesses respondent interest, attention span, discomfort, and comprehension, and highlights problems with the logical structure of questions/response options that can affect understanding. In the past this approach was not consistently used in the development or revision of movement disorders scales. METHODS: We applied qualitative cognitive pretesting using testing guides in development of the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The guides were based on qualitative techniques, verbal probing and "think-aloud" interviewing, to identify problems with the scale from the patient and rater perspectives. English-speaking Parkinson's disease patients and movement disorders specialists (raters) from multiple specialty clinics in the United States, Western Europe and Canada used the MDS-UPDRS and completed the testing guides. RESULTS: Two rounds of cognitive pretesting were necessary before proceeding to field testing of the revised scale to assess clinimetric properties. Scale revisions based on cognitive pretesting included changes in phrasing, simplification of some questions, and addition of a reassuring statement explaining that not all PD patients experience the symptoms described in the questions. CONCLUSIONS: The strategy of incorporating cognitive pretesting into scale development and revision provides a model for other movement disorders scales. Cognitive pretesting is being used in translating the MDS-UPDRS into multiple languages to improve comprehension and acceptance and in the development of a new Unified Dyskinesia Rating Scale for Parkinson's disease patients.

Overcoming inertia: increasing public health departments' access to evidence-based information and promoting usage to inform practice.

In 2010, the New England Region-National Network of Libraries of Medicine at University of Massachusetts Medical School received funding to improve information access for public health departments in 6 New England states and Colorado. Public health departments were provided with desktop digital access to licensed e-resources available through special pricing. In January through mid-April 2012, we evaluated the effectiveness of providing access to and training for using e-resources to public health department staff to motivate usage in practice. We found that additional strategies are needed to accomplish this.

IPMDS-Sponsored Scale Translation Program: Process, Format, and Clinimetric Testing Plan for the MDS-UPDRS and UDysRS.

We present the methodology and results of the clinimetric testing program for non-English translations of International Parkinson and Movement Disorder Society (MDS)-sponsored scales. The programs focus on the MDS revision of the UPDRS (MDS-UPDRS) and the Unified Dyskinesia Rating Scale (UDysRS). The original development teams of both the MDS-UPDRS and UDysRS envisioned official non-English translations and instituted a rigorous translation methodology. The formal process includes five core steps: (1) registration and start-up; (2) translation and independent back-translation; (3) cognitive pretesting to establish that the translation is clear and that it is comfortably administered to and completed by native-speaker raters and patients; (4) field testing in the native language using a large sample of Parkinson's disease patients; and (5) full clinimetric testing. To date, the MDS-UPDRS has 21 active language programs. Nine official translations are available, having completed all phases successfully, and the others are in different stages of development. For the UDysRS, 19 programs are active, with three official translations now available and the rest in development at different stages. Very few scales in neurology and none in movement disorders have fully validated translations, and this model may be adopted or modified by other scale programs to allow careful validation of translations. Having validated translations allows for maximal homogeneity of tools utilized in multicenter research or clinical trial programs.

Independent Spanish Validation of the Unified Dyskinesia Rating Scale.

The Unified Dyskinesia Rating Scale (UDysRS) assesses the severity and disability caused by dyskinesias in Parkinson's disease (PD). As part of the UDysRS development plan, the International Parkinson and Movement Disorder Society (MDS) established guidelines for official non-English translations. We present here the formal process for completing this program and the data on the first officially approved non-English version of the UDysRS (Spanish). The UDysRS translation program involves four steps: translation and back-translation; cognitive pretesting to ensure that raters and patients understand the scale and are comfortable with its content; field testing of the finalized version; and analysis of the factor structure of the tested version against the original English-language version. To be designated an official MDS translation, the confirmatory factor analysis comparative fit index (CFI) had to be ≥0.90. The Spanish UDysRS was tested in 253 native-Spanish-speaking patients with PD. For all four parts of the UDysRS, the CFI, was ≥0.94. Exploratory factor analyses of the Spanish version revealed a very clear factor structure, with three factors related to ON dyskinesia, OFF dystonia, and patient perceptions of the functional effect of dyskinesias. The Spanish version of the UDysRS successfully followed the MDS Translation Program protocol, reached the criterion to be designated as an official translation, and is now available on the MDS website for use.

Exploratory research to design a school nurse-delivered intervention to treat adolescent overweight and obesity.

OBJECTIVE: In preparation for a pilot study to evaluate the efficacy of a school nurse-delivered intervention, focus groups were conducted to gain insight into the perceptions of stakeholders regarding the design and implementation of the intervention. SETTING AND PARTICIPANTS: Fifteen focus groups at participating schools. One hundred subjects, including overweight and obese high school students, parents, high school nurses, and staff. MAIN OUTCOME MEASURE: Stakeholders' perceptions. ANALYSIS: Focus groups were audiotaped and transcribed verbatim. Theme instances related to the research aim were identified, coded, and sorted into theme categories. RESULTS: Major topics discussed included teen issues, family support, intervention implementation-related concerns, and curriculum content. Teen issues included dealing with peer pressure, avoiding emotional eating, and support from friends. Many participants thought it should be the teen's choice to involve parents. Confidentiality was the most commonly identified potential barrier to implementation. Recommendations for nutrition and physical activity curriculum content focused on concrete, practical strategies. CONCLUSIONS AND IMPLICATIONS: Results of this research provided insight into stakeholder's needs and perceptions regarding the content and structure of a school nurse-delivered intervention to treat adolescent overweight and obesity. Findings were used in the design and implementation of intervention protocols and materials.

Helping men make an informed decision about prostate cancer screening: a pilot study of telephone counseling.

OBJECTIVE: Evaluate a computer-assisted telephone counseling (CATC) decision aid for men considering a prostate specific antigen (PSA) test. METHODS: Eligible men were invited by their primary care providers (PCPs) to participate. Those consenting received an educational booklet followed by CATC. The counselor assessed stage of readiness, reviewed booklet information, corrected knowledge deficits and helped with a values clarification exercise. The materials presented advantages and disadvantages of being screened and did not advocate for testing or for not testing. Outcome measures included changes in stage, decisional conflict, decisional satisfaction, perceived vulnerability and congruence of a PSA testing decision with a pros/cons score. Baseline and final surveys were administered by telephone. RESULTS: There was an increase in PSA knowledge (p<0.001), and in decisional satisfaction (p<0.001), a decrease in decisional conflict (p<0.001), and a general consistency of those decisions with the man's values. Among those initially who had not made a decision, 83.1% made a decision by final survey with decisions equally for or against screening. CONCLUSIONS: The intervention provides realistic, unbiased and effective decision support for men facing a difficult and confusing decision. PRACTICE IMPLICATIONS: Our intervention could potentially replace a discussion of PSA testing with the PCP for most men.

Moving mammogram-reluctant women to screening: a pilot study.

BACKGROUND: Effective interventions are needed for women long overdue for screening mammography. PURPOSE: The purpose of this study is to pilot test an intervention for motivating overdue women to receive a mammogram. METHODS: Subjects aged 45-79 without a mammogram in > or =27 months and enrolled in study practices were identified from claims data. The intervention included a mailed, educational booklet, computer-assisted barrier-specific tailored counseling and motivational interviewing, and facilitated, short-interval mammography scheduling. RESULTS: Of 127 eligible women, 45 (35.4%) agreed to counseling and data collection. Most were > or =3 years overdue. Twenty-six (57.8%) of the counseled women got a mammogram within 12 months. Thirty-one (72.1%) of 43 counseled women moved > or =1 stage closer to screening, based on a modified Precaution Adoption Process Model. CONCLUSION: It is feasible to reach and counsel women who are long overdue for a mammogram and to advance their stage of adoption. The intervention should be formally evaluated in a prospective trial comparing it to control or to proven interventions.

Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results.

We present a clinimetric assessment of the Movement Disorder Society (MDS)-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UDPRS Task Force revised and expanded the UPDRS using recommendations from a published critique. The MDS-UPDRS has four parts, namely, I: Non-motor Experiences of Daily Living; II: Motor Experiences of Daily Living; III: Motor Examination; IV: Motor Complications. Twenty questions are completed by the patient/caregiver. Item-specific instructions and an appendix of complementary additional scales are provided. Movement disorder specialists and study coordinators administered the UPDRS (55 items) and MDS-UPDRS (65 items) to 877 English speaking (78% non-Latino Caucasian) patients with Parkinson's disease from 39 sites. We compared the two scales using correlative techniques and factor analysis. The MDS-UPDRS showed high internal consistency (Cronbach's alpha = 0.79-0.93 across parts) and correlated with the original UPDRS (rho = 0.96). MDS-UPDRS across-part correlations ranged from 0.22 to 0.66. Reliable factor structures for each part were obtained (comparative fit index > 0.90 for each part), which support the use of sum scores for each part in preference to a total score of all parts. The combined clinimetric results of this study support the validity of the MDS-UPDRS for rating PD.

Staging mammography nonadherent women: a qualitative study.

BACKGROUND: Few studies have related stages of mammography screening nonadherence with the rationale used by overdue women. METHODS: We used a grounded theory approach to obtain and analyze data from focus groups, telephone interviews, and surveys. Emergent specific themes were compared with emerging decision levels of nonadherence. Each decision level was then compared with the Precaution Adoption Process Model and the Transtheoretical Model. RESULTS: A total of 6 key themes influencing mammogram nonadherence emerged as did 6 decision levels. Variability within themes was associated with specific decision levels. The decision levels were not adequately classified by either stage model. CONCLUSIONS: Stage-based educational strategies may benefit by tailoring interventions to these 6 decision levels.

Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Process, format, and clinimetric testing plan.

This article presents the revision process, major innovations, and clinimetric testing program for the Movement Disorder Society (MDS)-sponsored revision of the Unified Parkinson's Disease Rating Scale (UPDRS), known as the MDS-UPDRS. The UPDRS is the most widely used scale for the clinical study of Parkinson's disease (PD). The MDS previously organized a critique of the UPDRS, which cited many strengths, but recommended revision of the scale to accommodate new advances and to resolve problematic areas. An MDS-UPDRS committee prepared the revision using the recommendations of the published critique of the scale. Subcommittees developed new material that was reviewed by the entire committee. A 1-day face-to-face committee meeting was organized to resolve areas of debate and to arrive at a working draft ready for clinimetric testing. The MDS-UPDRS retains the UPDRS structure of four parts with a total summed score, but the parts have been modified to provide a section that integrates nonmotor elements of PD: I, Nonmotor Experiences of Daily Living; II, Motor Experiences of Daily Living; III, Motor Examination; and IV, Motor Complications. All items have five response options with uniform anchors of 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Several questions in Part I and all of Part II are written as a patient/caregiver questionnaire, so that the total rater time should remain approximately 30 minutes. Detailed instructions for testing and data acquisition accompany the MDS-UPDRS in order to increase uniform usage. Multiple language editions are planned. A three-part clinimetric program will provide testing of reliability, validity, and responsiveness to interventions. Although the MDS-UPDRS will not be published until it has successfully passed clinimetric testing, explanation of the process, key changes, and clinimetric programs allow clinicians and researchers to understand and participate in the revision process.