The Mayo Clinic Manuscript Series Relative to the Discussion, Dissemination, and Operationalization of the Food and Drug Administration Guidance on Patient-Reported Outcomes

Sloan, Jeff A.; Halyard, Michele Y.; Frost, Marlene H.; Dueck, Amylou C.; Teschendorf, Bonnie; Rothman, Margaret

doi:10.1111/j.1524-4733.2007.00267.x

Cited by 40 publications

(24 citation statements)

References 17 publications

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“…without the interpretation of others [1]. The importance of PROs, as measured with patient-reported outcome measures (PROMs), is increasingly acknowledged in health care [2]. Examples of PROs are: pain, health-related quality of life (HRQoL), patients' experienced disease severity, treatment adherence and satisfaction with treatment.…”

Section: Introductionmentioning

confidence: 99%

Patient-Reported Outcome Measurement in Clinical Dermatological Practice: Relevance and Feasibility of a Web-Based Portal

Cranenburgh

Stege²,

Korte³

et al. 2015

Dermatology

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Background/Aims: Patient-reported outcomes (PROs) are increasingly considered important. We developed a web-based application to electronically assess PROs in routine dermatological practice. We assessed (1) the relevance of PRO measurement according to health care providers and patients, (2) the feasibility of our application in routine practice according to health care providers, supporting staff and patients, and (3) barriers/facilitators for implementation according to health care providers and supporting staff. Methods: Health care providers, supporting staff and patients completed study-specific questionnaires. Also, website statistics were analysed. Results: 3/6 clinics participated, including 9 professionals and 80 patients. Both health care providers and patients rated PRO measurement as relevant. However, implementation was only moderately feasible. Time constraints and logistical problems were mentioned as barriers, and motivated patients and supportive staff as facilitators. Conclusion: Electronic PRO assessment in routine practice is not self-evident. Adjustments in logistics are recommended to optimize implementation, using a plan-do-study-act approach.

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Section: Introductionmentioning

confidence: 99%

Patient-Reported Outcome Measurement in Clinical Dermatological Practice: Relevance and Feasibility of a Web-Based Portal

Cranenburgh

Stege²,

Korte³

et al. 2015

Dermatology

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“…4 Participants can report PROM-related health behaviors or physiological measurements (eg, blood glucose levels) in person at a clinic, on paper, or electronically using interactive voice response (IVR) telephone technology, computers, or smartphones. 5,6 PROM information reported to a patient's provider can be clinically useful and may help facilitate health behavior modification and disease management. 7 In addition, PROM data can be of great importance to research and has been used to determine eligibility for clinical trials, to strengthen communication with patients during clinical trials, and to determine treatment effectiveness.…”

mentioning

confidence: 99%

Recruiting 9126 Primary Care Patients by Telephone: Characteristics of Participants Reached on Landlines, Basic Cell Phones, and Smartphones

Serdarevic

Fazzino

MacLean

et al. 2016

Population Health Management

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In primary care, collecting information about patient health behaviors between appointments can be advantageous. Physicians and researchers who embrace phone-based technology may find valuable ways to monitor patient-reported outcome measures of health (PROM). However, the level of phone technology sophistication should be tailored to the phone use of the population of interest. Despite the growing use of telephones as a means to gather PROM, little is known about phone use among primary care patients. As part of an ongoing study, the authors recruited primary care patients (N = 9126) for a health behavior screening study by calling them on the primary contact number listed in their medical record. The current study evaluated the frequency with which individuals were reached on landlines, basic cell phones, and smartphones, and examined participant characteristics. The majority of participants (63%) used landlines as their primary contact. Of the 37% using cell phones on the recruitment call, most (71%) were using smartphones. Landline users were significantly older than cell phone users (61.4 vs. 46.2 years; P = .001). Cell phone use did not differ significantly between participants with a college education and those without (37% vs. 38%; P = .82); however, smartphone use did differ (61% vs. 77%; P = .01). The majority of participants sampled used landlines as their primary telephone contact. Researchers designing phone-based PROM studies for primary care may have the broadest intervention reach using interactive voice response telephone technology, as patients could report health outcomes from any type of phone, including landlines. (Population Health Management 2016;19:212-215)

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“…Among men in a stable relationship-those who had the regular opportunity to engage in sexual activity-who attempted sexual intercourse and activity in the past 4 weeks, levels of ED severity on the EF domain have been classified as follows: normal (no ED; score, 26-30); mild ED (22)(23)(24)(25); mild-to-moderate (17-21); moderate (11)(12)(13)(14)(15)(16)) and severe (6)(7)(8)(9)(10). 19,[41][42] For men in a stable relationship whose ED is so poor that they do not even attempt sexual activity, the severe ED scores range from 1 to 10.…”

Section: Erectile Function Domain Of the Iiefmentioning

confidence: 99%

“…A detailed review article on the SEAR questionnaire is published elsewhere. 27 Briefly, the 14 chosen items on SEAR questionnaire clustered into two domains: Sexual Relationship Satisfaction (items [1][2][3][4][5][6][7][8] and Confidence (items 9-14), the latter comprising Self-Esteem (items 9-12) and Overall Relationship Satisfaction (items 13-14) subscales (Table 5). As with the QEQ, the SEAR questionnaire has its constituent item responses summed to arrive at an individual's actual raw score for each domain and subscale, as well as his overall score, and the corresponding actual raw score is then transformed onto a 0-100 scale: transformed score ¼ 100 Â ((Actual raw scoreÀLow-est possible raw score)/Possible raw score range).…”

Section: Self-esteem and Relationship Questionnairementioning

confidence: 99%

“…In fact, as of this writing, the Food and Drug Administration has released a draft guidance to support labeling claims of patientreported measures in medical product development, 5 and an entire journal issue has been devoted to the topic. [6][7][8][9][10][11][12][13] An important purpose of clinical trials is 'to communicate information about the risks and benefits of new therapies to physicians, patients, and their families' so as to inform individual healthcare decisions in the clinical practice setting. 2 PROs are key to treatment decision-making, including shared decision-making, which can improve patient self-management.…”

Section: Introductionmentioning

confidence: 99%

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An assessment of patient-reported outcomes for men with erectile dysfunction: Pfizer's perspective

Cappelleri

Stecher

2008

Int J Impot Res

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Patient-reported outcomes (PROs) for men with erectile dysfunction (ED) have blossomed in the published literature and at professional conferences. These outcomes have been central to study the science of ED itself and to evaluate efficacy of treatment for men with ED. In this review article we highlight and distinguish among seven key PROs: the International Index of Erectile Function, for sexual function including erectile function; the Sexual Health Inventory for Men (SHIM), for diagnosis of ED; the Quality of Erection Questionnaire, for satisfaction with quality of erections; the Erectile Dysfunction Inventory of Treatment Satisfaction, for personal evaluation of treatment received; the Self-Esteem And Relationship questionnaire, for emotional well-being; the Erection Hardness Score (EHS), for targeting erection hardness and the Sexual Experience Questionnaire, for erection (both function and quality), individual satisfaction and couples satisfaction. Depending on the purpose of the investigation, all seven PROs have merit for use in clinical trials and at least deserve consideration in clinical practice. The SHIM and the EHS, given their aims and brevity, deserve special consideration in clinical practice. As a unit these seven PROs complement and supplement each other. Which ones to choose in a particular undertaking depends on the objective or purpose of a given study. These PROs acknowledge that sexual dysfunction and its treatment have multiple dimensions. Each of these instruments represents a significant contribution to sexual medicine research and, when used judiciously and appropriately, can help to provide optimal patient care and management.

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The Mayo Clinic Manuscript Series Relative to the Discussion, Dissemination, and Operationalization of the Food and Drug Administration Guidance on Patient-Reported Outcomes

Cited by 40 publications

References 17 publications

Patient-Reported Outcome Measurement in Clinical Dermatological Practice: Relevance and Feasibility of a Web-Based Portal

Patient-Reported Outcome Measurement in Clinical Dermatological Practice: Relevance and Feasibility of a Web-Based Portal

Recruiting 9126 Primary Care Patients by Telephone: Characteristics of Participants Reached on Landlines, Basic Cell Phones, and Smartphones

An assessment of patient-reported outcomes for men with erectile dysfunction: Pfizer's perspective

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