Heart and Blood Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nutritional and Metabolic Diseases

Hypertension

Breast Neoplasms

Prostatic Neoplasms

Hypercholesterolemia

Vascular Diseases

Hyperlipidemias

Hyperlipoproteinemias

Dyslipidemias

Metabolic Diseases

Lipid Metabolism Disorders

Herbal and Botanical

All Drugs and Chemicals

Cola

People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high cholesterol, who are either taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years. These people will see items only pertaining to high cholesterol.

People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high blood pressure, who are either taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years. These people will see items only pertaining to high blood pressure.

People between the ages of 50-75 with no previous diagnosis of colon cancer, who have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years, or who had first colon cancer screening in past 2 years. These people will see items only pertaining to colon cancer screening.

Females between the ages of 40-50 with no previous diagnosis of breast cancer who have had mammogram (or discussed having a mammogram) in the past 2 years, or had first mammogram in past 2 years. These people will see items only pertaining to breast cancer screening.

Men between the ages of 45-69 with no previous diagnosis of prostate cancer who have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years or had first prostate cancer screening in the past 2 years. These people will see items only pertaining to prostate cancer screening.

Karen Sepucha, PhD

The purpose of this study is to survey a sample of adults who have recently made a decision about treatment of high cholesterol or high blood pressure or a decision about screening for colorectal cancer, breast cancer, or prostate cancer. The main goal is to gather evidence of the validity and reliability of the Shared Decision Making Process scale. Secondary goal is to gather evidence on the quality of decisions for these common medical situations.

Study staff worked with a national sampling firm to recruit subjects for five different medical decisions. The five decisions are (1) treatment of high cholesterol, (2) treatment of high blood pressure (3) when to start breast cancer screening (4) whether or not to have prostate cancer screening and (5) which test to have for colorectal cancer screening. Respondents complete a survey about their experiences talking with health care providers about the specific clinical decision. The survey measured the amount of shared decision making, knowledge, preferences, decisional conflict and decision regret. The study will obtain 500 responses total, or 100 for each decision.

Sample is an online non-probability panel of adults living in the United States. In the survey, participants were screened to meet specific qualifications. After 1 week, a random selection of 50 respondents are invited to complete the retest instrument.

All analyses will be conducted separately for each group, and results may be pooled across cancer screening and medication contexts. First, study staff will examine the descriptives for the Shared Decision Making Process items. Study staff will also test several hypotheses to examine validity of the scores such as whether higher shared decision making process scores are associated with less decisional conflict and less regret. Staff will also examine retest reliability of the Shared Decision Making Process scale.

Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey

The study team will create a complete, cleaned, de-identified copy of the final data set for each online field test.

3 item measure of adherence to medication asked for the high cholesterol and high blood pressure sample participants who indicate that they are taking medicine. (patients in the cancer screening arm did not get this question). composite score ranged from 0-100, with higher scores indicating greater adherence to medication within the last 30 days.

The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process occurred.

Measures decisional conflict, consists of 4 yes/no items. Scores range 0-4 where 0 indicates no decisional conflict, and scores 1 to 3 indicate decisional conflict. The measure is often reported as a top-score of 0, thus the percentage of patients with a total score of 0 or no decisional conflict.

5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret.

Single item asking "If you knew then what you know now, do you think you would make the same decision about \[how to manage your high cholesterol/ how to manage your high blood pressure/breast cancer screening/colon cancer screening/ prostate cancer screening\]?" where the last part varies by group.

Response options are:

Definitely yes, Probably yes, Probably no, Definitely no

Single item asking patient "What did you want to do" in regard to (depending on the group) high cholesterol/high blood pressure/colon cancer screening/breast cancer screening/prostate cancer screening

Single item asking the participant who made the ultimate decision. The categorical response options are 1) the patient made the decision, 2)the provider made the decision, or 3) both patient and provider made the decision together.

Multiple choice knowledge items for each topic will be combined to a total knowledge score (0-100) with higher scores indicating higher knowledge

Carol Cosenza, Center for Survey Research at University of Massachusetts, Boston

Massachusetts General Hospital

Director of the Health Decision Sciences Center

Our definition of adverse event and/or serious adverse event did not differ.

High Cholesterol

High Blood Pressure

Colorectal Cancer Screening

Breast Cancer Screening

Prostate Cancer Screening

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

participants who had discussed with their healthcare provider about cancer screening (breast, colon, prostate) or medication for a chronic condition (high cholesterol, high blood pressure) within the last 2 years. Participants needed to have provided enough information to calculate the shared decision making process score (primary outcome of interest)

Dr. Karen R. Sepucha

participants who provided complete information to calculate a shared decision making process score (primary outcome of interest)

Shared Decision Making Process Measure

participants who completed all 4 items of the short decisional conflict scale. Only 532/533 participants provided enough information to calculate a SURE score.

Decisional Conflict Tool (SURE)

Participants who answered all 5 decision regret questions. Only 526/533 participants provided enough information to calculate decision regret score.

Decision Regret Scale

participants who answered the single-item regret question.

Single-Item Measure of Decision Regret

participants who answered the treatment preference question.

Treatment Choice

participants who answered the controlled preference scale question.

Adapted Controlled Preference Scale

Participants who completed the baseline survey were re-contacted approximately 1 week post-survey for a retest. Participants who completed the retest survey and provided enough information to calculate the shared decision making process score were part of this analysis.

Shared Decision Making Process Measure Retest

participants who answered at least 50% of the knowledge items in their respective clinical groups. Participants in the high cholesterol group were not given a knowledge score. Only 131/234 provided enough information to calculate a shared decision making process score (primary outcome of interest)

Knowledge

participants in the high cholesterol and high blood pressure groups who answered all 3 medication adherence questions. participants in the three cancer screening groups were not assigned medication adherence questions and thus were not part of this analysis. Only 56/100 (high cholesterol) and 68/96 (high blood pressure) participants provided enough information to calculate adherence score.

Adherence

Overall Study

Gland and Hormone Related Diseases

Infections

Nervous System Diseases

Behaviors and Mental Disorders

Digestive System Diseases

Blood and Lymph Conditions

Symptoms and General Pathology

Musculoskeletal Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Immune System Diseases

Diseases and Abnormalities at or Before Birth

Substance Related Disorders

Rare Diseases

Eczema

Kidney Diseases

Diabetes Mellitus

Alzheimer Disease

Depression

Depressive Disorder

Liver Diseases

Leukemia

Obesity

Heart Diseases

Arthritis

Communicable Diseases

Liver Cirrhosis

Osteoporosis

Bulimia

Bulimia Nervosa

Influenza, Human

Acquired Immunodeficiency Syndrome

HIV Infections

Hypersensitivity

Intestinal Diseases

Dyspepsia

Gout

Bronchitis

Appendicitis

Cellulitis

Liver Diseases, Alcoholic

Infectious Mononucleosis

Renal Insufficiency, Chronic

Renal Insufficiency

Disease Attributes

Dementia

Brain Diseases

Central Nervous System Diseases

Tauopathies

Neurodegenerative Diseases

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Chronic Disease

Gastrointestinal Diseases

Bone Diseases

Bone Diseases, Metabolic

Intraabdominal Infections

Gastroenteritis

Cecal Diseases

Respiratory Tract Infections

Bronchial Diseases

Respiratory Tract Diseases

Lung Diseases

Lung Diseases, Obstructive

Hyperphagia

Signs and Symptoms, Digestive

Skin Diseases

Skin Diseases, Infectious

Suppuration

Connective Tissue Diseases

Inflammation

Alcohol-Induced Disorders

Alcohol-Related Disorders

Substance-Related Disorders

Chemically-Induced Disorders

Chronic Graft Versus Host Disease

Familial Alzheimer Disease

Philippe B Wilson

Daniel JS Wolski

Imran Kapasi

Rishabh Prasad

This research programme seeks to combine the resources of NHS primary care, with the leading spectroscopic work in low-magnetic fields of the Wilson Group (Nottingham Trent University) to demonstrate the potential for benchtop Nuclear Magnetic Resonance (NMR) spectroscopy in human clinical pathology. This is an instrument assessment study for point of care viability which will also result in enhanced patient care (pending their consent) in blood screenings and metabolic health data.

The research project aims to gauge the efficacy of benchtop Nuclear Magnetic Resonance devices in a primary health care setting. The study design and methodology is as follows:

Typically, before a patient attends their routine standard of care blood test, they will speak with their local General Practitioner (GP) or a Registered Nurse (RN). At these visits, the medical professional will gauge the interest of the patient and test if they are eligible. If the patient is interested in becoming involved with research, and they are eligible for the study, they will be given a 'Study Information and Informed Consent Form' to read before their next visit. This allows for ample time to become fully informed on what the study entails, as well as to ask any questions they may have.

The 'Study Information and Informed Consent Form' document contains all information detailing: the purpose of the study, the significance of the research, and the patient's right to withdraw at any time (as in accordance with General Data Protection Regulations \[GDPR\] 2018), potential risks and benefits of taking part in the study and who to contact if the patient had any further questions to be asked.

At the patient's routine standard of care visit, they will present their signed and dated consent form to the medical professional taking the biological samples. If the patient loses their consent form before this visit, they will be given another to complete in full before any residual biological samples are taken. This will be counter-signed by the medical professional present at their visit. The patient will then be anonymised by being given a unique identifier in the form of a barcode. This barcode will be applied to the consent form, and the form will act as a linking document. The patient will only be referred by their unique identifier for the remainder of the study. This anonymisation of identifiable patient information (such as name, Date of Birth \[DoB\], etc.) extends to any data produced by analysing the patient's samples. The patient will keep a copy of the consent form for their own records, whilst the original document will be held by the research team to be stored on-site behind several layers of security. A copy of the consent form will also be uploaded onto the patients SystmOne profile. SystmOne is a clinical computer system used by medical professionals to log patient visits, review tests results and upload any new relevant data.

After sample collection, no further actions are required of the patient for the remainder of the study. The patient will be given a debriefing document thanking them for their contribution. Within this document there are contact details of the researchers involved and other contact telephone numbers to a variety of organisations and helplines specialising in emotional support, if the patient feels in any way affected by the study. The patient will also be offered the opportunity to be given a copy of their bio fluid spectral data should they be interested in this. This will be accompanied by explanatory notes.

The biological samples collected from the patient will go to two different locations: samples taken as part of the patient's routine standard of care will go to a local diagnostics lab where they will be tested on a variety of metrics. Residual biological samples will be processed and tested at the local Willows Health Near Patient Testing laboratory, before being frozen at -80oC.

The test results provided by the diagnostics lab will be uploaded to the patient's SystmOne account, where they will be scribed and used for the study, as outlined in the 'Study Information and Informed Consent Form' document. Results gathered from the Willows Health Near Patient Testing laboratory will also be uploaded to the patients SystmOne account and stored for later use within the study. The combination of these two sets of data will form the Near Patient Testing data set.

The residual biological samples frozen at Willows Health will then be transferred in batch format to Nottingham Trent University's (NTU's) benchtop Nuclear Magnetic Resonance device. They will then be thawed, prepared further and analysed using the benchtop Nuclear Magnetic Resonance device. The resultant spectra will be stored on the password protected device to form the benchtop Nuclear Magnetic Resonance data set. With both sets of data gathered (Near Patient Testing suite and benchtop Nuclear Magnetic Resonance spectra), a machine learning algorithm will cross-compare the data sets to 'teach' a program to 'read' the benchtop Nuclear Magnetic Resonance spectra and output data in the form of Near Patient Testing machines.

On average, \~42 patients attend the Willows Health Medical Centre for routine standard of care visits per week in which biological samples are collected for pathology lab testing. This equates to \~168 samples per month. With the sample collection window planned to take a year, this calculates to \~2016 potential participants being involved within the study. This is an estimated maximum, as not all patients who come for their annual review may not consent to the research study. Additionally, some religious events and holidays may limit the uptake of potential participants, for example: during Ramadan, although it is not strictly prohibited, blood tests may be avoided due to the weakening effect it may have. This, in conjunction with fasting, may dissuade potential participants from joining the study.

Given the substantial volumes of data required to 'train' software when utilising machine learning algorithms, the sample size needs to be large. This is imperative to produce accurate and reliable results from training and test sets for machine learning algorithms.

This research will result in several advantages for both clinical care and patients. For instance, efficient and rapid analysis of biological fluids will help to overcome the limitations associated with diagnosis of a variety of diseases such diabetes, chronic kidney disease, cancer and any other conditions that might go asymptomatic in the early stages. This work has the potential to pave the way for new clinical pathological techniques to support the early diagnosis of diseases.

Residual samples will be collected from patients visiting the Willows Health Medical Centre for their routine standard of care checkups.

Residual biological samples will be comprised of whole blood which will be processed into serum, analysed on local Near Patient Testing machines and frozen at -80'C. They will then be transported to Nottingham Trent University, thawed and analysed on the benchtop Nuclear Magnetic Resonance device.

Benchtop NMR Spectroscopy for Assessment of Clinical Human Pathologies (BRANCH-P STUDY)

Preclinical Drug Discovery Informed by Public Health: Initiating a Step-Change in the Development of New Human Models

An \>0.97 (or 97%) area under the receiver operating characteristic (AUROC) of benchtop Nuclear Magnetic Resonance versus current Point of Care (POC) testing sensitivity/specificity in conditional classification of samples.

Nottingham Trent University

Willows Health

Study title	NCT ID	Conditions	Eligibility	Organization
Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey	NCT04317690	High Cholestero... High Blood Pres... Colorectal Canc... Breast Cancer Prostate Cancer	30 Years - 75 Years	Massachusetts General Hospital
Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey	NCT04317690	High Cholestero... High Blood Pres... Colorectal Canc... Breast Cancer Prostate Cancer	30 Years - 75 Years	Massachusetts General Hospital
Benchtop NMR Spectroscopy for Assessment of Clinical Human Pathologies (BRANCH-P STUDY)	NCT05473325	Diabetes Chronic Kidney ... Cancer Bowel Disease Cardiovascular ... Mononucleosis Flu Heart Diseases HIV Infections AIDS and Infect... Bulimia Chest Infection... Arthritis Leukaemia Alcoholic Liver... Allergies Alzheimer Disea... Appendicitis Eczema Bronchitis Cellulitis Cirrhosis Depression Gout High Cholestero... Indigestion Obesity Osteoporosis	18 Years -	Willows Health

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