Development and verification of a method for measuring the impact of hemorrhoid symptoms.

Abstract

Disclosed is a method for assessing a patient's health, which includes presenting a patient-reported outcome index (PROM) for the patient to complete, at least partially, about an illness, injury, or condition. The PROM includes questions other than those relating to symptoms or signs of the illness, injury, or condition. The method further includes performing calculations as a function of responses to the questions in order to assess the patient's health. Certain embodiments include correlating the results of the calculations with objective measures of symptoms or signs in order to produce patient-reported outcome information for assessing the patient's health.

Description

Technical Field

[0001] The present invention relates to the development and validation of a method for measuring the impact of hemorrhoid disease symptoms.

Background Art

[0002] Background Hemorrhoid disease (HD) affects 10 million people in the United States at any given time, and 50% of the US population (i.e., 167 million people) will develop symptomatic hemorrhoids during their lifetime. Approximately 60% of people with hemorrhoids experience symptoms. Despite its prevalence and impact on quality of life, existing patient-reported outcome measures for HD have not been validated using standard psychometric methods.

Summary of the Invention

[0003] Summary An exemplary embodiment of the present invention is a patient-reported outcome assessment system for use in HD clinical research, the Hemorrhoid Disease Symptom and Impact Measure (HD-SIM™ assessment system). This began with a qualitative phase consisting of cognitive interviews with 16 patients. Through four interviews, an item pool was created and refined to elicit optimal instructions, item wording, and response options. The quantitative phase was a web survey of 1,066 HD patients, and a subsample of 100 patients responded to a follow-up survey 1-2 weeks later. The sample was stratified to be evenly distributed across mild, moderate, and severe categories. The HD-SIM system includes 38 items representing six subscales: worst symptoms, best symptoms, bowel health problems, impact on life, impact on mental health, and manageability. Psychometric analysis demonstrated that the subscales have excellent internal consistency reliability, cross-sectional construct validity (i.e., convergent validity, discriminant validity, known-group validity), test-retest stability, and longitudinal construct validity (i.e., responsiveness). Taken together, these psychometric evidences indicate that the HD-SIM system is a clinical research measurement tool suitable for the purpose of measuring the symptom impact of hemorrhoid disease in clinical trial research.

[0004] A particular embodiment may be a method for assessing a patient's health by (a) presenting a patient-reported outcome measure (PROM) for the patient to at least partially complete about an illness, injury, or condition (the PROM includes questions that extend beyond questions about symptoms or signs of the illness, injury, or condition); and (b) performing calculations as a function of the answers to the questions in order to assess the patient's health.

[0005] This method may further include correlating the calculation results with objective measurements of symptoms or signs in order to generate patient-reported results information for evaluating the patient's health.

[0006] The questions may include questions about physical symptoms, questions specifically directed towards bodily tissues affected by the disease causing the physical symptoms, questions about the manageability of the disease, questions about the mental health impacts caused by the disease or physical symptoms, and questions about the impact of the disease on daily life.

[0007] An exemplary embodiment is directed toward hemorrhoidal disorders, and the questions may include at least a subset of the following related to the corresponding questions: (a) Symptoms: pain during defecation (BM), pain not during BM, burning, itching, bleeding, anal leakage, discomfort, pain while sitting; (b) Bowel health: constipation, emptying of the bowel, number of times going to the toilet, time spent in the toilet, cleanliness around the anus, avoiding defecation while away from home; (c) Manageability: manageable, manageable symptomatic effect, effective therapeutic effect; (d) Impact on mental health: worry, worsening, distractibility, unpredictability, isolation, embarrassment, mood, self-esteem; (e) Impact on life: impact on sleep, interference with daily activities, interference with enjoyable time with others, impact on ability to care for others, impact on physical intimacy, and protection of underwear.

[0008] Exemplary embodiments may be directed towards hemorrhoidal disorders, and the questions may include whether a burning sensation is experienced during urination, and whether pain occurs during and / or at other times.

[0009] Exemplary embodiments may include questions relating to symptoms or signs, prompting responses regarding the best and worst states of those symptoms or signs.

[0010] In one embodiment, the method performs calculations to generate the mean and standard deviation of unweighted scores based on patient responses. The method can characterize the severity of a disease, injury, or condition into at least three categories: severe, moderate, and mild. Alternatively, the method can calculate scores along a continuum of available responses.

[0011] This method can be performed at the beginning and end of the study period, in which case it may include performing at least one physical measurement of the affected body tissue as at least part of the objective measurements at the beginning and end of the study period. Correlating the calculation results may include correlating the output information reported by the patient at the beginning and end of the study period with at least one physical measurement of the affected body tissue.

[0012] Treatment for illness, injury, or condition may be applied during the study period, and this method may include determining whether the affected tissue correlates with the progression of the illness, injury, or condition based on multiple physical measurements of the affected tissue.

[0013] Exemplary embodiments of this method can be applied to diseases such as hemorrhoids, and at least one physical measurement includes measuring blood flow through the hemorrhoidal vein or artery. At least one measurement may include Doppler measurement to quantify the size, shape, and volume at the beginning and end of the investigation period.

[0014] This method may include reporting patient-reported outcome information in a way that allows for the selection of a treatment profile.

[0015] The method may be performed on multiple study patients who have been administered the drug or treated with the device, and on multiple control patients who have not been administered the drug or treated with the device, and the method may further include reporting patient-reported outcome information for both the multiple study patients and the multiple control patients to the regulatory body responsible for approving the drug or device.

[0016] Another exemplary embodiment is a method for assessing the condition of hemorrhoids. The exemplary embodiment includes (a) observing varicose veins in areas of hemorrhoidal tissue in a patient, having hemorrhoidal veins and arteries; (b) measuring pressure and blood flow in the hemorrhoidal veins or arteries over length, width, and volume; and (c) assessing the condition of hemorrhoids as a function of at least one of varicose veins, pressure, and blood flow. The exemplary embodiment may be performed at the beginning and end of a treatment protocol period.

[0017] The method according to this exemplary embodiment may further include (a) obtaining responses from patients to patient-reported outcome measurements directed toward hemorrhoids; (b) classifying the severity of hemorrhoids as a function of the patient's responses in order to determine a severity category; and (c) comparing the hemorrhoid condition with the severity categories. The method may further include recommending a treatment plan as a function of the results of the comparison.

[0018] Another exemplary embodiment is a computer implementation method for assessing a patient's health. This exemplary embodiment includes (a) enabling a patient to provide at least partial answers to patient-reported result measurements (PROMs) relating to an illness, injury, or condition via an electronic medium (PROMs include questions that extend beyond questions relating to symptoms or signs of an illness, injury, or condition); (b) performing calculations on an electronic medium or a server coupled to an electronic medium as a function of the answers to the questions; and (c) correlating the results of the calculations with objective measurements of symptoms or signs to generate patient-reported result information for assessing the patient's health.

[0019] Abbreviations CDC Centers for Disease Control and Prevention (USA) CFA Confirmatory Factor Analysis CORECTS Clinical Outcomes Rectal Evaluation Scale CTT Classical Test Theory EFA Exploratory Factor Analysis FDA Food and Drug Administration HD Hemorrhoid disease HD-SIM™ System Hemorrhoid Disease Symptom Impact Measure System HIPAA Health Insurance Portability and Accountability Act IRT Item Response Theory NDA New Drug Application PRO Patient-Reported Outcomes PROM Patient-Reported Outcome Measures PROMIS Patient-Reported Outcomes Measurement Information System QOL Quality of Life WHO World Health Organization

[0020] HD-SIM™ is a trademark of Cristcot LLC

[0021] Brief Description of the Drawings The above will be apparent from the following more particular description of the exemplary embodiments illustrated in the tables and drawings scattered throughout this specification. The drawings are not necessarily to scale, with emphasis instead being placed upon illustrating embodiments.

Brief Description of the Drawings

[0022] [Figure 1] Shows a patient-driven conceptual model and item pool [Figure 2] Figure 2 is the result of an analysis of variance model examining how much variance each subscale explains in discriminating between mild, moderate, and severe HD groups. All subscales except CTT-administered ability showed a large effect size (ES) in detecting differences between HD severity groups (bars exceeding the orange cut point indicate a large effect size).

Best Mode for Carrying Out the Invention

[0023] Detailed explanation The following describes exemplary embodiments.

[0024] Hemorrhoids (HD) affect 10 million people at any given time in the United States (Pullen Luchtefeld), and 50% of the US population (i.e., 167 million people) will experience symptomatic hemorrhoids at some point in their lives. 85% of women experience anal fistulas during the third trimester of pregnancy (Simmons). The prevalence of anal fistulas in the population is approximately 4%, and this prevalence increases with age. More than half of people over 50 experience symptoms (Riss).

[0025] Hemorrhoids are present in everyone, but are generally unnoticed until symptoms appear (Lunsford). Approximately 60% of HD patients experience symptoms (Sun). The most common symptoms of HD are pain, bleeding, itching, swelling, and discomfort. HD patients also report abdominal bloating, abdominal pain, excessive tension, a feeling of incomplete urination, and frequent urination (Johannsson). The symptoms of HD negatively impact well-being, social life, and overall quality of life (Johannsson), but do not affect mortality (Lunsford).

[0026] Symptoms manifest as increased venous drainage from the rectum and dilation of the sinuses supplied by the superior and middle hemorrhoidal arteries and the superior rectal artery. Factors that increase pelvic floor pressure contribute to hemorrhoid formation, such as chronic frequent diarrhea, obesity, pregnancy and childbirth, anal sex, pelvic floor dysfunction, and worsening of cirrhosis complicated with ascites (Molt).

[0027] Treatment for hemorrhoids varies depending on the severity of symptoms and poor response to previous treatment interventions. Initial treatment for hemorrhoids often involves dietary and lifestyle modifications (high-fiber diet), alternating hot and cold sitz baths, use of stool softeners, nonsteroidal anti-inflammatory drugs, and commercially available creams and pads (Lunsford). In most cases, conservative management is effective. For more severe cases, especially internal hemorrhoids resistant to conservative treatment, more invasive approaches include rubber band ligation, infrared photocoagulation, sclerotherapy, and surgery. These invasive approaches are painful, take longer to recover from, and have a higher incidence of complications. The recurrence rate of hemorrhoids varies. For example, 30-50% of people experience hemorrhoid recurrence within 5-10 years after banding, compared to 2-5% after surgical hemorrhoidectomy (Mott).

[0028] The annual cost in the United States in 2014 was estimated to be as high as $2.4 billion (Yang). Given such a large disease burden and cost, it is time for focused research to understand the causes, symptoms, and best treatments for symptomatic hemorrhoids (Sandler).

[0029] To meet this need, it is useful to have reliable and effective methods for assessing the severity of hemorrhoidal hemorrhage (HD) and its impact on patients' quality of life. Current research has problems with clinicians' assessments of HD severity, and there are no effective methods for assessing the impact on symptoms of anal fistulas. For example, Dekker et al. conducted a reliability test of the Goligher classification system (Goligher) and reported moderate inter-rater agreement for grades I and IV, and only fair agreement for grades II and III (Dekker).

[0030] Because the effects of hemorrhoidal hemorrhoids (HD) are associated with symptoms best assessed by the individual experiencing it, HD is a disease that would be well-served by having a valid patient-reported outcome (PRO) scale. Numerous studies have reported on the development of HD PROs. Longchamp et al. conducted a systematic review of the HD literature to evaluate scoring systems and concluded that there is an urgent need for a simple, externally validated, comprehensive scoring system for HD, including the Coloproctology Core Outcome Set (Van Tol). This Core Outcome Set includes PROs and clinician-assessed outcomes. All HD PROs are very similar in that they rely on a similar set of short hemorrhoidal symptoms in assessing disease severity. They do not address the multifaceted impact of HD on patients' lives and quality of life. Furthermore, none of these scales have been adequately validated in accordance with the 2009 Food and Drug Administration (FDA) PRO guidance. Therefore, these scales cannot be used for the approval or labeling of HD treatments.

[0031] Method Phase I: Interview Phase to Develop the Conceptual Model and Items of HD PRO Endpoint Model At the start of the project, the PRO was envisioned to include a “Symptoms” subscale intended to be the primary endpoint for measuring the severity of disease impact in subsequent clinical trials, and a subscale reflecting the impact of HD on quality of life. These subscales could potentially serve as secondary or exploratory endpoints in subsequent clinical trials.

[0032] Initial Concept Model The initial conceptual model was developed considering the work done by the European Society of Coloproctology to create the Core Outcome Set (Van Tol). This Delphi study questioned healthcare professionals about outcome areas and outcomes that appeared relevant to hemodialysis (HD) based on a systematic literature review. A review of previous studies suggested that the main areas were symptoms (primary outcome), complications, recurrence, and patient satisfaction (secondary outcome).

[0033] Based on the ideas within this Core Outcome Set, and in order to align with the World Health Organization's (WHO) concept of health, we anticipated that the new PRO conceptual model should be multidimensional and focus on symptoms, physical functioning, mental health, and social functioning, particularly those relevant to HD.

[0034] Item pool available for HD-SIM systems The final 39-item item pool reflected a conceptual model of HD consisting of five aspects: symptoms (best and worst), gut health, impact on life, impact on mental health, and manageability (Figure 1). Symptom items were asked for "worst" and "best" symptoms to capture variability in symptoms.

[0035] Figure 1. Patient-led conceptual model and item pool [ka]

[0036] recall period The recall period for all items in the HD-SIM system is "within the past 24 hours," and it is reliable and valid regardless of whether the questions are asked daily or only at baseline, midpoint visits, or the end of the study.

[0037] Answer options The response options for the symptom items ranged from "[No symptoms]" to "[Very severe]". In the online survey, to ensure that each item required a response (i.e., participants had to answer to proceed to the next item or page), an option for "I wish not to answer" was included. This structure of response options adheres to ethical and scientific guidelines.

[0038] Most other items in the HD-SIM system used answer choices ranging from "never" to "very often" or "prefer not to answer." The question about the frequency of experiencing constipation or blockage had slightly different answer choices, ranging from "never" to "always" or "prefer not to answer."

[0039] Methods Phase II Study Design This survey was conducted using a web-based survey platform, the secure Alchemer engine (www.alchemer.com), which complies with the Health Insurance Portability and Accountability Act (HIPAA).

[0040] Design. This study was a cross-sectional study involving approximately 1,000 HD patients, with 100 participants randomly selected within 1-2 weeks of the completion of the initial survey to undergo retesting. The baseline and retesting samples for HD were stratified by self-reported severity of HD symptoms (i.e., mild, moderate, and severe). Study participants were sampled to be nationally representative of the U.S. population in order to stratify by age and race.

[0041] Results Phase II - Quantitative Item Development Stage sample Data from 1,075 individuals was collected. Data from 9 individuals were removed from the analysis dataset because valid answers were not obtained to the question regarding the duration of HD (e.g., they answered "0"), and their HD status was questionable. Table 3 shows the descriptive characteristics of the Phase II trial sample.

[0042] Demographic characteristics: The mean age of participants was 47.5 years. There were 639 women, 424 men, and 1 transgender person. Racially, 71% were white, 21% black, and the remainder other. 15% were Hispanic. Most of the sample (57%) were married or cohabiting, living with a spouse or partner (58%) and / or other relatives (48%). Approximately one-quarter of the sample had a primary school, high school, or vocational degree, 57% had a community college or four-year university degree, and 19% had a postgraduate degree. More than half were currently employed. 45% of the sample reported having some to significant financial hardship.

[0043] Health and HD-specific characteristics. The majority of the sample (64%) were non-smokers, and 87% had health insurance. The average number of complications was three, and the average duration of HD was 12.2 years. Approximately one-third of the sample had mild HD, 45% had moderate HD, and 23% had severe HD. Approximately two-thirds reported having internal hemorrhoids, and approximately four-thirds had external hemorrhoids (participants were able to check for both types).

[0044] Scoring of items and areas Two scores were created. The CTT score was calculated for six conceptual subscales, and the IRT score was calculated for two subscales, primarily based on model fit statistics. Specifically, the CTT-based score was calculated as the average of the items within each subscale, provided that participants answered 50% of the items (i.e., at least four items had to be answered in an eight-item subscale). The IRT-based score was derived from a conversion table from raw total scores to IRT scale scores, based on the item parameters obtained in the above analysis. The IRT scale score is a T-score with a mean of 50 and a standard deviation of 10.

[0045] Performance comparison Next, a series of analyses were conducted to evaluate the two score sets according to their performance on key PRO metrics.

[0046] Overlap. Pearson correlation analysis revealed that the two score sets showed a high correlation. The CTT score for worst symptoms correlated with the IRT score for worst symptoms at 0.97. The CTT scores for gut health issues, impact on life, and mental health also showed a high correlation with the overall impact IRT score (r=0.91, 0.90, and 0.97, respectively). All of these correlation coefficients were large effect sizes using Cohen's criteria (38). Thus, the overlap between the two scores was very high.

[0047] Cross-sectional construct validity Identifying known groups Figure 2 shows the results of an analysis of variance model that examined how well each subscale explains the variance in distinguishing between mild, moderate, and severe HD groups. All subscales except CTT management ability showed large effect sizes (ES) when detecting differences between HD severity groups (bars exceeding the orange cutoff point indicate large effect sizes).

[0048] Figure 2. Validity of known group: Differentiation of mild, moderate, and severe hemodialysis. [ka]

[0049] Convergence and divergence Supplementary Table 8 shows descriptive statistics for general QOL indicators and PROs specific to HD.

[0050] Respondent's burden The HD-SIM system was tested for respondent burden using the Alchemer survey engine's testing function. The results showed low fatigue levels and high accessibility. The estimated time for the entire HD-SIM system was 4 minutes, and 2 minutes for the worst-case and best-case symptom subscales.

[0051] The following supplementary table illustrates embodiments of the HD-SIM system applicable to the study and analysis of hemorrhoids. The collected and analyzed data may differ for different diseases, injuries, or conditions.

[0052] [Table 1-1]

[0053] [Table 1-2]

[0054] [Table 2]

[0055] [Table 3]

[0056] [Table 4]

[0057] [Table 5]

[0058] Recommendations in Clinical Trials Frequency of assessment. For HD treatment, it is recommended to use daily assessments of worst and best symptoms before, during, and after administration of the investigational drug. In contrast, it is recommended to use impact subscales at the start, mid-term, and end of the trial. This measurement method is simple, provides a useful measure of symptom severity and variability, and records the therapeutic effect on important areas of life.

[0059] Limitations of the research This study for the development and validation of the HD-SIM system has many advantages, including a robust sample size that is relatively evenly distributed across HD severity. The study sample is diverse in terms of race and ethnicity, and reflects the general U.S. population in terms of age, sex, and region. The only limitation of this study is that it is the first to use the HD-SIM system. Since the measurement method will be validated iteratively over many studies and over time, the results of this study should be considered preliminary.

[0060] conclusion The HD-SIM system is a reliable and effective PRO for use in HD clinical trials and observational clinical studies. The HD-SIM system's user-friendly and concise format makes it a useful tool with demonstrated cross-sectional and longitudinal reliability and validity. Overall, the HD-SIM system is well-prepared and suitable for HD studies measuring the impact of therapeutic interventions on symptoms. [Examples]

[0061] Computer implementation embodiment The HD-SIM system can be implemented via individual electronic devices, a network system having edge nodes and a central server, or via other computer systems or network configurations known in the art that can be configured to support the functions disclosed herein. For example, the HD-SIM system can provide a portal through which a patient can be presented with a questionnaire of the HD-SIM system regarding the condition of their hemorrhoids, such as the following: The user can select answers by selecting radio buttons or other graphical user interface elements, and input from the patient can be taken. The answers may be quantified for mathematical processing in order to perform an evaluation according to the embodiments disclosed herein. A server supporting the portal can then perform operations to produce an output as described herein.

[0062] Embodiment of supplementary data The HD-SIM system can enable the submission of physical measurements in addition to patient-provided data. For example, in a hemorrhoid application, at least one physical measurement may include the measurement of blood flow through the hemorrhoidal vein or artery. Alternatively or additionally, at least one physical measurement may be performed at the beginning and end of the study period to quantify the size, shape, and volume of the hemorrhoidal vein or artery, or other relevant structure.

[0063] Tools that may be employed for such physical measurements include high-resolution endoscopic cameras and Doppler systems for hemorrhoid treatment. Doppler measurements are used to provide a model of varicose veins in the affected area, particularly in relation to varicose veins in other areas of the body, not just hemorrhoidal veins. "Four-dimensional" measurements of pressure and flow within veins (or arteries) can be measured and quantified beyond length, width, and volume measurements. In clinical trial protocols, the use of devices to perform such measurements, determined by a central reader (not the treating physician), to provide baseline (i.e., at the start of treatment) and end-of-treatment measurements may allow for the examination of the relevant characteristics of patient-reported impacts on any changes or stagnation of quantifiable measurements by readings of anatomical structures, as well as controlled protocols.

[0064] Measurement of hemorrhoid symptoms and effects (CTT version) HDSIMr: Worst vs Best The following questions deal with symptoms caused by hemorrhoids. We are interested in the fluctuations in your symptoms over the past day. The following questions ask about the worst (i.e., most severe) and best (i.e., least severe) times you experienced symptoms in the past 24 hours.

[0065] 1. When you feel the urge to defecate, the pain from hemorrhoids is In the worst case How strong was it? No pain; mild; moderate; severe; very severe; unwilling to answer. ○ ○ ○ ○ ○ ○

[0066] 2. When you feel the urge to defecate, the pain from hemorrhoids is At the best time How strong was it? No pain Mild Moderate Severe Very severe I don't want to answer ○ ○ ○ ○ ○ ○

[0067] 3. When you don't feel the urge to have a bowel movement, the pain from hemorrhoids is... In the worst case How strong was it? No pain Mild Moderate Severe Very severe I don't want to answer ○ ○ ○ ○ ○ ○

[0068] 4. When you don't feel the urge to have a bowel movement, the pain from hemorrhoids is... At the best time How strong was it? No pain Mild Moderate Severe Very severe I don't want to answer ○ ○ ○ ○ ○ ○

[0069] 5. Burning sensation related to hemorrhoids during urination, In the worst case How strong was it? No burning sensation Mild Moderate Severe Very severe I don't want to answer ○ ○ ○ ○ ○ ○

[0070] 6. Burning sensation related to hemorrhoids during urination, At the best time How strong was it? No burning sensation Mild Moderate Severe Very severe I don't want to answer ○ ○ ○ ○ ○ ○

[0071] 7. Itching related to hemorrhoids, In the worst case How strong was it? No itching, Mild, Moderate, Severe, Very Severe, I don't want to answer ○ ○ ○ ○ ○ ○

[0072] 8. Itching related to hemorrhoids, At the best time How strong was it? No itching, Mild, Moderate, Severe, Very Severe, I don't want to answer ○ ○ ○ ○ ○ ○

[0073] 9. Regarding bleeding related to hemorrhoids, Worst case What was the situation like? (For example, did you wipe yourself when not using the toilet, or did you soil your underwear?) No bleeding, Mild, Moderate, Severe, Very severe, I don't want to answer ○ ○ ○ ○ ○ ○

[0074] 10. Regarding bleeding related to hemorrhoids, Best time What was the situation like? (For example, did you wipe yourself when not using the toilet, or did you soil your underwear?) No bleeding, Mild, Moderate, Severe, Very severe, I don't want to answer ○ ○ ○ ○ ○ ○

[0075] 11. Regarding leakage from the anus, Worst case What was it like? (For example, soiled underwear, or feces on toilet paper even though there was no bowel movement.) No leakage from the anus Mild Moderate Severe Very severe I don't want to answer ○ ○ ○ ○ ○ ○

[0076] 12. Regarding leakage from the anus, Best time What was it like? (For example, soiled underwear, or feces on toilet paper even though there was no bowel movement.) No leakage from the anus Mild Moderate Severe Very severe I don't want to answer ○ ○ ○ ○ ○ ○

[0077] 13. Discomfort related to hemorrhoids, In the worst case How strong was it? No discomfort Mild Moderate Severe Very severe I don't want to answer ○ ○ ○ ○ ○ ○

[0078] 14. Discomfort related to hemorrhoids, At the best time How strong was it? No discomfort Mild Moderate Severe Very severe I don't want to answer ○ ○ ○ ○ ○ ○

[0079] 15. Pain while sitting, In the worst case How strong was it? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0080] 16. Pain while sitting, At the best time How strong was it? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0081] Gut health over the past 24 hours Page description The following questions concern the symptoms and effects of hemorrhoids. Answers must reflect events from the past 24 hours.

[0082] 17. How often did you experience a feeling of blockage or constipation due to hemorrhoids? Never, almost never, somewhat, often, always, don't want to answer ○ ○ ○ ○ ○ ○

[0083] 18. To what extent were you bothered by the increased frequency of going to the toilet due to hemorrhoids? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0084] 19. To what extent were you bothered by the long time you spent going to the toilet due to hemorrhoids? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0085] 20. To what extent have you been troubled by the difficulty of properly cleaning your anus due to hemorrhoids? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0086] 21. To what extent did you avoid defecating when you were not at home? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0087] Impact on daily life over the past 24 hours 22. To what extent did hemorrhoids affect your sleep last night? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0088] 23. To what extent did symptoms related to hemorrhoids interfere with your daily activities (e.g., housework, taking time off, doing things you wanted to do)? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0089] 24. To what extent did the symptoms of hemorrhoids affect your ability to spend time doing enjoyable things with other people (e.g., activities with friends, family, or a romantic partner)? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0090] 25. To what extent did hemorrhoids affect your ability to care for family members or cohabitants (e.g., caring for children or providing care for someone providing care support)? Not applicable Not at all Somewhat Somewhat Quite a lot Very much I don't want to answer ○ ○ ○ ○ ○ ○ ○

[0091] 26. To what extent did hemorrhoids affect physical intimacy (e.g., nudity, sexual activity)? Not at all A little Somewhat A lot A lot Not applicable I don't want to answer ○ ○ ○ ○ ○ ○ ○

[0092] 27. Due to hemorrhoids, how often were you unable to wear the underwear or clothing you normally wear? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0093] Impact on mental health 28. To what extent did you feel worried or anxious about the symptoms of hemorrhoids? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0094] 29. How much have your hemorrhoid symptoms worsened? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0095] 30. To what extent were you preoccupied with the symptoms of hemorrhoids? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0096] 31. To what extent were the symptoms of hemorrhoids unpredictable? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0097] 32. To what extent did you feel lonely due to the symptoms of hemorrhoids? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0098] 33. To what extent did you feel embarrassed by the symptoms of hemorrhoids? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0099] 34. To what extent did the symptoms of hemorrhoids affect your mood? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0100] 35. To what extent did the symptoms of hemorrhoids affect your self-esteem? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0101] management ability 36. To what extent were you able to manage your hemorrhoid symptoms? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0102] 37. To what extent were the hemorrhoid symptoms manageable? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○

[0103] 38. To what extent were you confident that the hemorrhoid treatment would be effective? Not at all A little A bit A lot A lot I don't want to answer ○ ○ ○ ○ ○ ○ thank you!

[0104] References

[0105] [ka]

[0106] [ka]

[0107] [ka]

[0108] All patents, published applications, and references cited herein are incorporated in their entirety by reference.

[0109] While exemplary embodiments have been specifically shown and described, it will be understood by those skilled in the art that various modifications can be made in form and detail without departing from the scope of embodiments included in the appended claims.

Claims

1. A method for evaluating a patient's health, the method is a) A step of presenting a patient-reported outcome measurement (PROM) for the patient to complete at least partially about an illness, injury, or condition, wherein the PROM includes questions other than those relating to symptoms or signs of the illness, injury, or condition; and b) A step in which calculations are performed as a function of the answers to the questions in order to assess the patient's health. A method that includes this.

2. The method according to claim 1, further comprising correlating the results of a calculation with objective measurements of symptoms or signs in order to produce patient-reported results information for evaluating the patient's health.

3. The method according to claim 1 or 2, wherein the questions include questions relating to physical symptoms and at least one question selected from the group consisting of questions specifically directed to bodily tissues affected by the disease causing the physical symptoms, questions relating to the manageability of the disease, questions relating to the mental health impacts caused by the disease or physical symptoms, and questions relating to the impact on life resulting from the disease.

4. The disease is hemorrhoids, and the questions relate to at least the following subset of the corresponding questions: a) Symptoms: pain during bowel movements (BM), pain at other times, burning sensation during urination, itching, bleeding, anal leakage, discomfort, pain when sitting; b) Intestinal health: constipation, empty bowels, frequency of toilet visits, duration of toilet visits, cleanliness of the anal area, avoiding defecation while away from home; c) Manageability: The symptoms and therapeutic effects are manageable and can be treated; d) Impact on mental health: worry, worsening of symptoms, distractibility, unpredictability, isolation, embarrassment, mood, self-esteem; e) Impact on daily life: affects sleep, interferes with daily activities, interferes with enjoying time with others, affects the ability to care for others, affects physical intimacy, protects underwear The method according to claim 3, including the method described in claim 3.

5. The method according to claim 3, wherein the disease is hemorrhoidal disease.

6. The method according to claim 5, wherein the questions include whether a burning sensation is experienced during urination, or whether pain occurs during and / or at any other time during defecation.

7. The method according to claim 3, wherein the questions relating to symptoms or signs prompt answers relating to the best and worst conditions of those symptoms or signs.

8. The method according to claim 1, wherein the calculation generates the mean and standard deviation of unweighted scores based on responses from patients.

9. The method according to claim 1, further comprising characterizing the severity of a disease, injury, or condition into at least three categories: severe, moderate, and mild.

10. The method according to claim 1, wherein the calculation generates a score along a continuum within the available range of responses.

11. A method performed at the beginning and end of a study period, further comprising, at the beginning and end of the study period, performing at least one physical measurement of the affected body tissue as at least part of objective measurements; the method according to claim 2, wherein the correlation of calculation results comprises correlating output information reported by the patient at the beginning and end of the study period with at least one physical measurement of the affected body tissue.

12. The method according to claim 11, further comprising applying treatment for a disease, injury, or condition during the study period, and further determining whether the affected body tissue correlates with the progression of the disease, injury, or condition based on multiple physical measurements of the affected body tissue.

13. The method according to claim 11, wherein the disease is hemorrhoidal disease, and at least one physical measurement includes measuring blood flow through a vein or artery of the hemorrhoid.

14. The method according to claim 11, wherein at least one measurement includes a Doppler measurement for quantifying the size, shape, and volume at the beginning and end of the test period.

15. The method according to claim 2, further comprising reporting patient-reported outcome information in a manner that enables the selection of a treatment profile.

16. A method performed on multiple test patients who have received drug administration or treatment with a device, and on multiple control patients who have not received drug administration or treatment with a device, further comprising reporting patient-reported outcome information of both the multiple test patients and the multiple control patients to a regulatory body responsible for approving the drug or device.

17. A method for evaluating the condition of hemorrhoids, the method being: a) In patients with hemorrhoidal veins and arteries, the step of observing varicose veins in the area of ​​tissue affected by hemorrhoidal disease; b) the step of measuring the pressure and blood flow of the hemorrhoidal vein or artery over its length, width and volume; and c) A step of assessing the state of hemorrhoidal disease as a function of at least one of varicose veins, pressure, and blood flow. A method that includes this.

18. The method according to claim 17, which is performed at the beginning and end of the treatment protocol period.

19. a) A step of obtaining responses from patients to patient-reported outcome measurements directed towards hemorrhoidal disease; b) A step of classifying the severity of hemorrhoidal disease as a function of the patient's response in order to determine the severity category; and c) A step to compare the condition of hemorrhoids with a severity category. The method according to claim 18, further comprising:

20. The method according to claim 19, further comprising recommending a treatment plan as a function of the results of the comparison.

21. A computer implementation method for evaluating a patient's health, the method being a) A step enabling a patient to provide at least a partial response to a patient-reported outcome measurement (PROM) relating to an illness, injury, or condition via an electronic medium, wherein the PROM includes questions that go beyond questions relating to symptoms or signs of the illness, injury, or condition; b) The step of performing calculations on an electronic medium or a server connected to an electronic medium as a function of the answer to the question; and c) Steps to associate calculation results with objective measurements of symptoms or signs and create patient-reported results information for evaluating the patient's health. A method that includes this.

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