Abstract:
An internet-based patient health outcome data collection system, and a system for accessing information from the collected database. The system includes a web-based patient and doctor interface that allows both a patient and doctor to separately input data into the data collection database. The web-based patient interface allows a patient to input data such as responses to questions regarding levels of pain, function, satisfaction, quality of life, activities of daily living, unexpected results, and questions, pre- and post-procedure. The doctor interface also includes an analysis tool that allows the doctor to analyze the data from a specific patient, a group of patients, or all the patients, with specific characteristics as chosen by the doctor. The doctor interface also allows the doctor to compare an individual patient against a group of the doctor&#39;s patients, all patients in the study that meet criteria chosen by the doctor, or global data.

Description:
[0001]    This application claims the benefit of U.S. Provisional Application No. 61/425,097, filed on Dec. 20, 2011. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention is directed to a health outcome data collection system and, more particularly, to an internet-based medical procedure outcome system that collects data from patients and doctors to create an interactive health outcome data collection system and allow analysis of the collected data. 
       BACKGROUND OF THE INVENTION 
       [0003]    A database for measuring and recording patient treatment results is effective for answering clinical questions with regard to outcomes, costs, and cost-effectiveness of medical procedures. Information on large numbers of patients, treated by large numbers of providers, and the outcomes of the medical treatments, are collected and input into the database. 
         [0004]    The information in a medical outcome database may include baseline characteristics, procedure interventions and costs, and subsequent outcomes of subjects, and allows subsequent retrospective and prospective review and analysis of specific included cohorts of subjects as well as comparative-effectiveness research of different cohorts. The collected data provides a measurement for the value of orthopedic sports medicine, arthroscopy procedures, arthroplasty and other medical procedures. The collected data also allows a user to compare products and procedures, not just on the basis of cost or reimbursement, but on outcomes and objective findings as well. Utilization of a practice based orthopedic procedure registry across a broad provider network may also enable the efficient collection of scientific evidence adequate to permit analysis of outcomes, costs, and cost-effectiveness associated with medical interventions and approved orthopedic devices. As a result, a health outcome data collection system allows determination of the comparative effectiveness of different procedures and, ultimately, a determination of the best method for treating patients. 
         [0005]    Accordingly, it would be desirable to provide a health outcome data collection system that is efficient, easy to use and provides compilation of data to provide valuable information regarding the efficiency and cost-effectiveness of medical procedures. 
       SUMMARY OF THE INVENTION 
       [0006]    The present invention provides an internet-based patient health outcome data collection system, and a system for accessing information from the collected database. The system includes a web-based patient and doctor interface that allows both a patient and doctor to separately input data into the data collection database. The web-based patient interface allows a patient to input data such as responses to questions regarding levels of pain, function, satisfaction, quality of life, activities of daily living, unexpected results, and questions, pre- and post-procedure. The doctor interface also includes an analysis tool that allows the doctor to analyze the data from a specific patient, a group of patients, or all the patients, with specific characteristics as chosen by the doctor. The doctor interface also allows the doctor to compare an individual patient against a group of the doctor&#39;s patients, all patients in the study that meet criteria chosen by the doctor, or global data. In this manner, the invention provides a comprehensive way of tracking a patient from beginning to end. 
         [0007]    The present invention also provides a method of collecting patient data for the health outcome data collection system. The method comprises the following steps: a doctor inputs general patient information; next, the system generates a questionnaire and notifies the patient about the questionnaire; the patient then accesses the system through a secure web-link included in the email from the system and responds to the questionnaire; next, the doctor performs the procedure (or any type of health treatment) and inputs information about the procedure, the diagnosis, and recovery into the system; the system generates another questionnaire and notifies the patient about the questionnaire; and the patient then accesses the system through a secure web-link in the email sent from the system and responds to the questionnaire. This feedback can be used to alert the doctor to complications. Multiple questionnaires may be generated and responded to at varying intervals, before and after the procedure. The system automatically scores each questionnaire individually and adds their scores into the database. The doctor reviews and analyzes the patient&#39;s response and compares the response to averages from other patients in the database. 
         [0008]    Global de-identified data is automatically compiled for third party data analysis and use by all doctors, worldwide, for comparison purposes. 
         [0009]    These and other features and advantages of the invention will be more apparent from the following detailed description that is provided in connection with the accompanying drawings and illustrated exemplary embodiments of the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]      FIG. 1  illustrates a procedure outcome system with a database; 
           [0011]      FIG. 2  illustrates an exemplary method of using the system of  FIG. 1  to collect patient data; 
           [0012]      FIG. 3  illustrates an exemplary patient details interface of the system of  FIG. 1  used by a doctor to input data; 
           [0013]      FIG. 4  illustrates an exemplary current patients interface of the system of  FIG. 1  used by a doctor to monitor patients; 
           [0014]      FIG. 5  illustrates an exemplary patient analysis interface used by a doctor to analyze data; 
           [0015]      FIG. 6  illustrates an exemplary patient input interface used by a patient to input data; and 
           [0016]      FIG. 7  illustrates another exemplary patient input interface used by a patient to input data. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0017]    The following description is provided to enable any person skilled in the art to make and use the invention and sets forth the best modes contemplated by the inventors of carrying out their invention. Various modifications, however, will remain readily apparent to those skilled in the art. 
         [0018]      FIG. 1  illustrates a procedure outcome system  115  that includes a database  110 . The procedure outcome system  115  allows for data collection and analysis of the data. The system  115  employs a web-portal  116  to collect data from doctors  120 ,  122 . Designees for each doctor  120 ,  122  may also access the system  115  and input and view information on behalf of the doctors  120 ,  122 . If one person is designee for more that one doctor, that person will be able to access surgeons&#39; data from one access point. The system  115  also collects data from patients  130 ,  132  of doctor  120  and patients  140 ,  142  of doctor  122 . System  115  is not limited to collecting data from only a certain number of doctors and/or a certain number of patients of each doctor, but is robust and may handle data input from numerous doctors and their patients or other patients. 
         [0019]    Using the web-portal  116  of system  115 , the doctors  120 ,  122  view the data collected from their respective patients  130 ,  132  and  140 ,  142 . The doctors  120 ,  122  may also compare data from their respective patients  130 ,  132  and  140 ,  142  with de-identified data averages collected from all the patients  130 ,  132 ,  140 ,  142 . Further if a doctor chooses to show the patient, each patient  130 ,  132 ,  140 ,  142  may view his/her data and also data averages collected from all the patients  130 ,  132 ,  140 ,  142 . Additionally, third parties  150  may also enter data and view combined datasets collected from all the patients  130 ,  132 ,  140 ,  142 . 
         [0020]    A data collection method  200  for collecting data from the patient  130  and the patient&#39;s doctor  120  using the system  115  is described with regard to  FIG. 2 . Step  210  of data collection method  200  involves obtaining an authorization to participate from patient  130  before a patient is included in the system (and before the procedure is performed). During step  220 , the doctor  120  accesses the system  115  through the on-line interface or web portal  116  and enters the information of the patient  130  into the database  110 . During step  230 , the system  115  sends a notification to the patient  130  that the system  115  has generated a questionnaire for the patient  130 . The system  115  notifies the patient  130  through email. The email includes a URL (uniform resource locator) that will direct the patient  130  to the web-portal  116 . Additionally, the patient  130  may be notified by telephone, mail, text message or other means of communication. During step  236 , the patient  130  accesses the web-portal  116  or wireless data collection tool (IPAD) of system  115  and responds to the system generated questionnaire. The system automatically scores the given responses to each questionnaire and saves each individual score in the database. 
         [0021]    The procedure is performed on the patient  130  by the doctor  120  during step  240 . During step  245 , the doctor  120  accesses the system&#39;s web-portal  116  and enters related post-procedure information into the database  110 . The system  115  then generates an additional questionnaire and sends a notification to the patient  130  that a questionnaire has been generated during step  250 . The notification sent during step  250  may be similar to the notification sent to the patient  130  during step  230 . The patient  130  then accesses the web-portal  116  of the system  115  during step  256  and responds to the questionnaire. Steps  250  and  256  may be repeated numerous times, using a different combination of questionnaires at each time. For example, the system  115  may generate questionnaires for the patient  130  and repeat steps  250  and  256  at the following post-procedure times: 3 days, 7 days, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months and 1 and 2 years. As the patient  130  responds to the questionnaires during step  256 , the doctor  120  tracks and monitors the patient&#39;s responses to the questionnaires during step  260 . The system  115  may also send a notification to the doctor  120  depending on the responses given by the patient  130  in step  256 . For example, if the patient&#39;s  130  response indicates that the patient  130  is experiencing a health problem related to the procedure, the system  115  may notify the doctor  120  of the problem. 
         [0022]      FIGS. 3-5  illustrate various aspects of the portion of the web-portal  116  provided to the doctor  120 .  FIG. 3  illustrates a patient details interface  310  used by the doctor  120  to input data concerning the patient  130 . For example, before the procedure on the patient  130 , the doctor  120  accesses the system  115  through the web-portal  116  using a unique login and password and enters the patient&#39;s  130  Custom ID (or medical record number) which uniquely identifies the patient, the date that the patient authorization was signed, the projected date of procedure, demographic data, general medical history, diagnosis, and the doctor&#39;s  120  and patient&#39;s  130  e-mail addresses. Additional information fields include gender, age at procedure, date of procedure, doctor, facility cost, procedure time, workers comp case, medical history, and site of the injury. 
         [0023]    After the procedure, the doctor  120  enters information about the exact diagnosis and concomitant injuries experienced by the patient  130 . The doctor also enters information about the procedure performed, including the type of procedure, cost data, medicine use, and any graft and implant use. For example, if the patient  130  had complications with his/her knee, the system  115  may require the doctor  120  to input the exact diagnosis and concomitant injuries associated with the complications, the procedure that was performed, the type of graft used if any, and the type of implant used if any. For example, the system  115  may prompt the doctor  120  to select all the following types of injuries that could apply and then provide the doctor  120  with the following list: ACL Tear, PCL Tear, MCL Tear, LCL Tear, PLC Tear, MMT, LMT, Loose Body (&gt;1 cm), Synovitis, Patellar Dislocation/Patello-femoral, Knee Dislocation, Previous HTO, Articular Cartilage Injury (Outerbridge Grade). To ensure uniformity in the database  110 , the system  115  only allows the doctor  120  to check options that apply, and limits written input—written input may be allowed in certain fields, but with the understanding by the doctor that data cannot be filtered in the analysis section. 
         [0024]    Similar lists could be provided for the type of procedure or treatment performed and/or the type of graft or implant used. For example, the system  115  may prompt the doctor  120  to select from the following types of procedures that were performed: ACL reconstruction, PCL reconstruction or repair, MCL reconstruction or repair, LCL reconstruction or repair, meniscectomy repair, cartilage repair, osteotomy, etc. 
         [0025]    The doctor  120  also enters any other non-surgical treatment, such as injections/applications, or complications during the period for which the patient  130  is responding to questionnaires. The system may prompt the surgeon to enter post-operative physical examination measurements depending on the procedures done on the patient. 
         [0026]      FIG. 4  illustrates a current patients interface  410  used by the doctor  120  to monitor his or her patients  130 ,  132 . The current patients interface  410  allows a user to filter patient cases. The current patients interface  410  also provides a visual reference as to which patient information is up-to-date and which patient has missing data. 
         [0027]      FIG. 5  illustrates a patient analysis interface  510  used by the doctor  120  to track and analyze the data provided by the doctors  120 ,  122  and patients  130 ,  132 ,  140 ,  142 . The doctor  120  may view a graph representing the data from a single patient  130 , all the doctor&#39;s  120  patients  130 ,  132 , or all the patients  130 ,  132 ,  140 ,  142  in the system  115 . Additional customized graphs or reports may also be created based on selected variables such as gender, age, surgical technique, surgical device, other treatments, medicine used, etc. This allows the doctor  120  or a third party  150  to compare results between surgical devices, medicine, and/or techniques, and to view outcomes (scores) of patients. Further, the data from the database  110  may be analyzed to determine the effectiveness and cost-effectiveness of procedures and implants. The system  115  may also be used to educate the patients  130 ,  132 ,  140 ,  142  on average recovery times and the average length and intensity of pain following a procedure. Additionally, datasets from one site or multiple sites can be combined for surgeon groups at one facility or multi-site clinical studies. 
         [0028]    Other features and attributes of the system are as follows:
       The doctor may generate pdf forms of selected criteria from patient data. This document can be printed or saved in pdf format.   The doctor may attach certain de-identified images to patient cases.   The doctor may allow his or her EMR company to draw information from or add information to the system.   The doctor may select certain patient information to export.   The doctor may import previously collected patient data into the system.   The doctor may choose to customize certain fields of the database including but not limited to time points of survey collection, questionnaires, objective measurements pre and post-op. Customization can be done alone, at a site, and at the surgeon or patient level.   The doctor may be able to select language translations for individual patients as well as to surgeon portal.   The doctor may be able to assign various privilege levels to their designers including, but not limited to, access to billing/payment screen, access to patient analysis, access to data entry, ability to customize/modify surgeon parameters.   The doctor may be able to add a note section to an individual patient case.       
 
         [0038]      FIG. 6  illustrates a patient input interface  610  used by the patient  130  to input data (i.e., responses to questions) into the database  110 . Patient input interface  610  allows the patient  130  to respond to questions using a VAS (Visual Analog Scale)  620  or other forms of response such as the response dialog  710  shown in  FIG. 7 . The questionnaires generated by the system  115  address questions regarding health related quality of life, pain, and function. For example, if patient  130  is scheduled for knee arthroscopy treatment, the patient  130  may be requested to complete the SF-12, KOOS (Knee injury and Osteoarthritis Outcome Score), VAS (Visual Analog Scale) and/or Marx Activity Score (pre-op, and 1 and 2 years post-op only). Similarly, if the patient  130  is scheduled for shoulder arthroscopy treatment, the patient  130  may be requested to complete the SF-12, Simple Shoulder Test (SST), American Shoulder and/or Elbow Surgeon&#39;s Subjective Shoulder Scale (ASES). 
         [0039]    Additionally, before the procedure, the patient  130  may also be asked to answer questions related to his or her post-procedure expectations (pain reduction, improvement in motion and strength, normal function for daily living and/or normal function for sports). Post operation, at multiple times, such as at 3 days, 7 days, and 2 and 4 weeks post-procedure, the patient  130  may be requested to rate their level of pain using the VAS and answer if they are taking pain and/or sleeping medication due to their procedure. At 6 weeks, 3 months, 6 months, and 1 and 2 years post-procedure, the patient  130  may complete the same surveys for health related quality of life, pain and function as he/she did pre-procedure. Additionally, at 1 year post-procedure, the patient  130  may be asked if the procedure met his/her expectations. At each post-procedure time point, the patient  130  may be requested to check a yes/no response box if he or she has had any unexpected events. If the “Yes” response box is checked for unexpected events, an email may be sent to the doctor  120  to alert the doctor  120 . If the patient  130  fails to complete the surveys and provide the data in the specified time, an additional email reminder may be sent to the patient  130  to request completion. 
         [0040]    All data transfer and data communication between the system  115  and the doctor  120  and the patient  130  takes place online over a secure, encrypted channel (SSL). Data can be entered by the patient  130  or the doctor  120  if the patient  130  does not have access to a computer, using the web-portal  116  or “IPAD.” To access the portal, the patient  130  clicks on a link in an e-mail that he or she receives from the system  115 , which directs the patient  130  to the secure portal landing page. The doctor  120  can also access the same link from within the system  115 . The link contains a query string that uniquely identifies the patient as well as the data point for which the data submission is being made. The link generated is completely random and is not determined based on any of the patient&#39;s  130  identifiable information. 
         [0041]    Access to the system  115  by the doctor  120  and the patient  130  is carefully controlled by the system  115 , and data within the database  110  is kept as confidential as possible. The doctor  120  has a unique login and password in order to access, view and input data into the system  115 . The doctor  120  is only able to view his or her patients&#39; data as well as global average values of the de-identified data in the database  110 . The doctor  120  will not be able to view the doctor&#39;s  122  data other than in the form of global averages unless a data sharing agreement is executed by all parties involved. 
         [0042]    Although the present invention has been described in connection with preferred embodiments, many modifications and variations will become apparent to those skilled in the art. While the preferred embodiments have been described and illustrated above, it should be understood that these are exemplary only and are not to be considered as limiting.