Research Protocol for an Observational Health Data Analysis on the Adverse Events of Systemic Treatment in Patients with Metastatic Hormone-sensitive Prostate Cancer: Big Data Analytics Using the PIONEER Platform.

Combination therapies in metastatic hormone-sensitive prostate cancer (mHSPC), which include the addition of an androgen receptor signaling inhibitor and/or docetaxel to androgen deprivation therapy, have been a game changer in the management of this disease stage. However, these therapies come with their fair share of toxicities and side effects. The goal of this observational study is to report drug-related adverse events (AEs), which are correlated with systemic combination therapies for mHSPC. Determining the optimal treatment option requires large cohorts to estimate the tolerability and AEs of these combination therapies in "real-life" patients with mHSPC, as provided in this study. We use a network of databases that includes population-based registries, electronic health records, and insurance claims, containing the overall target population and subgroups of patients defined by unique certain characteristics, demographics, and comorbidities, to compute the incidence of common AEs associated with systemic therapies in the setting of mHSPC. These data sources are standardised using the Observational Medical Outcomes Partnership Common Data Model. We perform the descriptive statistics as well as calculate the AE incidence rate separately for each treatment group, stratified by age groups and index year. The time until the first event is estimated using the Kaplan-Meier method within each age group. In the case of episodic events, the anticipated mean cumulative counts of events are calculated. Our study will allow clinicians to tailor optimal therapies for mHSPC patients, and they will serve as a basis for comparative method studies.

Reduction in Average Length-of-Stay in Emergency Department of a Low-Income Country's Cancer Hospital.

Introduction: Prolonged length of stay (LOS) in emergency departments (ED) is a widespread problem in every hospital around the globe. Multiple factors cause it and can have a negative impact on the quality of care provided to the patients and the patient satisfaction rates. This project aimed to ensure that the average LOS of patients in a tertiary care cancer hospital stays below 3 hours. Materials and Methods: The Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) approach was followed. Results: The average LOS was 166 minutes before implementing interventions. The two primary reasons for the increased length of stay were delays secondary to physician assessment and diagnostic lab reports. Strategies were defined to control these factors, which helped reduce the average length of stay to 142 minutes, a 30% reduction. Conclusion: A process improvement model similar to this project is recommended to enhance the quality of hospital services. It will provide valuable insights into the process flow and assist in gathering precise data on the various steps involved. The data collected can then be analyzed to identify potential causes and make informed decisions that can significantly improve hospital processes.

Head and Neck Cancer-Related Pain: A Descriptive Analysis of the Pain Phenotypes.

Objective: This study aimed to describe the clinical characteristics and prevalence of different painful phenotypes in head and neck cancer (HNC)-related pain. Materials and Methods: A cross-sectional study was conducted on 100 patients who presented with HNC-related pain. All patients underwent a comprehensive clinical assessment and were stratified in one or more painful phenotypes constructed based on the International Classification for Orofacial Pain, first edition, and International Classification for Headache Disorders, third edition. Results: Among the participants included, 68% were male, and the mean age of the cohort was 49.71 ± 14.14 years. The most prevalent cancer sites were the tongue (29%) and buccal mucosa (24%). The average pain intensity was 5.88 ± 2.53 on an 11-point numeric verbal pain rating scale, where 0 was indicative of "no pain" and 10 was suggestive of "worst pain imaginable". However, the worst pain intensity over the last month was 8.95 ± 1.53. The average number of pain sites per patient was 6, and the most common pain descriptors were dull ache, burning, and sharpness. Myofascial pain, jaw bone pain, and burning pain disorder were the most common phenotypes, and on average, three different phenotypes co-existed. Conclusion: HNC-related pain has a varying and complex clinical profile, which may mirror the pain profiles of primary pain disorders, such as myofascial pain, jaw bone pain, or burning pain disorders, and often presents together as a cluster of phenotypes.

The clinical presentation of head and neck cancer (HNC)-related pain varies considerably. This study assessed 100 patients with HNC-related pain. It stratified their symptoms into one or more known painful disorders based on the International Classification for Orofacial Pain, first edition and International Classification for Headache Disorders, third edition. It was found that HNC-related most commonly resembled myofascial pain, jaw bone pain, and burning pain disorder. On average, features of three different types of painful disorders co-existed. These results help illustrate the uniqueness and difficulty associated with managing HNC-related pain.

Integrating real-world data from Brazil and Pakistan into the OMOP common data model and standardized health analytics framework to characterize COVID-19 in the Global South.

OBJECTIVES: The aim of this work is to demonstrate the use of a standardized health informatics framework to generate reliable and reproducible real-world evidence from Latin America and South Asia towards characterizing coronavirus disease 2019 (COVID-19) in the Global South. MATERIALS AND METHODS: Patient-level COVID-19 records collected in a patient self-reported notification system, hospital in-patient and out-patient records, and community diagnostic labs were harmonized to the Observational Medical Outcomes Partnership common data model and analyzed using a federated network analytics framework. Clinical characteristics of individuals tested for, diagnosed with or tested positive for, hospitalized with, admitted to intensive care unit with, or dying with COVID-19 were estimated. RESULTS: Two COVID-19 databases covering 8.3 million people from Pakistan and 2.6 million people from Bahia, Brazil were analyzed. 109 504 (Pakistan) and 921 (Brazil) medical concepts were harmonized to Observational Medical Outcomes Partnership common data model. In total, 341 505 (4.1%) people in the Pakistan dataset and 1 312 832 (49.2%) people in the Brazilian dataset were tested for COVID-19 between January 1, 2020 and April 20, 2022, with a median [IQR] age of 36 [25, 76] and 38 (27, 50); 40.3% and 56.5% were female in Pakistan and Brazil, respectively. 1.2% percent individuals in the Pakistan dataset had Afghan ethnicity. In Brazil, 52.3% had mixed ethnicity. In agreement with international findings, COVID-19 outcomes were more severe in men, elderly, and those with underlying health conditions. CONCLUSIONS: COVID-19 data from 2 large countries in the Global South were harmonized and analyzed using a standardized health informatics framework developed by an international community of health informaticians. This proof-of-concept study demonstrates a potential open science framework for global knowledge mobilization and clinical translation for timely response to healthcare needs in pandemics and beyond.

Improving the efficiency and reducing variability in patient flow in an outpatient parenteral antibiotic therapy unit of a tertiary care hospital.

Outpatient parenteral administration of medications and blood transfusions using an outpatient parenteral antibiotic therapy (OPAT) unit has gradually become a standard of care. We report a continuous quality improvement project that was conducted on an OPAT unit of a tertiary care cancer hospital in Lahore, Pakistan. Prior to the initiation of the project, it was identified that 52% of the patient encounters in the OPAT unit were being delayed by a median of 63.5 minutes. A cause-and-effect analysis was performed, using a fishbone diagram, to identify the reasons for the delay in appointments. Based on the findings, several modifications were made to the processes of the OPAT unit including, but not limited to, a computerised physician order entry (CPOE) system module for prescribing, dispensing, reviewing and dispensing medications, changes in the nursing and staffing roster, and assignment of additional duties to the ward clerks. These changes resulted in improvement of waiting time to a median of 24.5 minutes and percentage delay in patient meetings decreased to 18%. Likewise, in 2019, 5,399 (27%) more patient meetings took place compared with 2018, which would have otherwise costed the hospital between 21.28 to 45.85 million Pakistani rupees. The use of continuous quality improvement techniques in the OPAT unit can result in substantial and appropriate changes in the process of patient flow, leading to measurable and significant reductions in the variability of care, and optimisation of service.

Improving Compliance of Physicians in Reporting and Documenting Critical Alerts in a Cancer Hospital.

Introduction: A critical result of an investigation is considered a representation of a pathophysiological state deemed to be high risk or life threatening for the patient. Therefore, such results should be addressed in an appropriate and timely manner. Unfortunately, routine closed chart audits suggested that the compliance of physicians in documenting critical alerts in patient notes was poor. This prompted the hospital to conduct a continuous quality improvement (CQI) project to improve the physicians' compliance. Materials and Methods: A cause-and-effect analysis was conducted using a fishbone diagram to identify the reasons for poor compliance. Based on the analysis, several modifications were made, including, but not limited to, hospital-wide educational sessions on the standard operating procedures of receiving and documenting critical alerts for the physicians, daily audit of critical alerts to review the appropriateness of documentation and introduction of a new module in the hospital electronic medical record to acknowledge and document receiving critical alerts. Results: Before implementing the strategies to improve physicians' documentation compliance, the average compliance rate was 57% in April 2020, and the median compliance rate was 52% (January 2020-April 2020). However, afterward, within a couple of months of implementing changes, the average compliance rate increased to 88%. This improvement was sustained for the next 8 months (median of 89%). Conclusion: This study found that CQI approach can be used to improve the compliance of the physicians for appropriately and timely documenting critical alerts, in this case, by continued education and training process and incorporating changes into the electronic hospital information system.

Development of an international Core Outcome Set (COS) for best care for the dying person: study protocol.

BACKGROUND: In contrast to typical measures employed to assess outcomes in healthcare such as mortality or recovery rates, it is difficult to define which specific outcomes of care are the most important in caring for dying individuals. Despite a variety of tools employed to assess different dimensions of palliative care, there is no consensus on a set of core outcomes to be measured in the last days of life. In order to optimise decision making in clinical practice and comparability of interventional studies, we aim to identify and propose a set of core outcomes for the care of the dying person. METHODS: Following the COMET initiative approach, the proposed study will proceed through four stages to develop a set of core outcomes: In stage 1, a systematic review of the literature will identify outcomes measured in existing peer reviewed literature, as well as outcomes derived through qualitative studies. Grey literature, will also be included. Stage 2 will allow for the identification and determination of patient and proxy defined outcomes of care at the end of life via quantitative and qualitative methods at an international level. In stage 3, from a list of salient outcomes identified through stages 1 and 2, international experts, family members, patients, and patient advocates will be asked to score the importance of the preselected outcomes through a Delphi process. Stage 4 consists of a face-to-face consensus meeting of international experts and patient/family representatives in order to define, endorse, and propose the final Core Outcomes Set. DISCUSSION: Core Outcome Sets aim at promoting uniform assessment of care outcomes in clinical practice as well as research. If consistently employed, a robust set of core outcomes for the end of life, and specifically for the dying phase, defined by relevant stakeholders, can ultimately be translated into best care for the dying person. Patient care will be improved by allowing clinicians to choose effective and meaningful treatments, and research impact will be improved by employing internationally agreed clinically relevant endpoints and enabling accurate comparison between studies in systematic reviews and/or in meta-analyses.

Reasons for Admission and Outcome to an Acute Palliative Care Unit in Patients with Advanced Malignancy in a Cancer Hospital.

Introduction: The alleviation of suffering is a primary goal of palliative care team for patients with terminal cancer. In some cases, patients experience symptoms requiring inpatient care. The purpose of this investigation was to assess the clinical presentation and outcomes of hospitalisation in patients that were admitted to the acute palliative care service. Materials and Methods: This is a retrospective descriptive study looking at admissions to an acute palliative care unit in a single centre over a 24-month period. Medical records of all patients, admitted in palliative care unit from 1 January, 2013, to 31 December, 2014, were reviewed for reason of admission and outcome. Results: A total of 226 patients were identified and included in the present investigation. Among these, 55.5% (125) were females. The median age of the cohort was 48 (15-86) years. The most common reasons for admission were alteration in consciousness (19.5%), respiratory tract infection (18%), diarrhoea and/or vomiting (14.2%) and respiratory distress (not related to infection) (13.4%). The median duration of hospital stay was 4 (0- 27) days. The majority of the patients were discharged home (65.1%). However, a significant portion (33.1%) of the patients did not survive the hospitalisation. Following discharge from the hospital, at 4-weeks follow-up, the survival rate was 38.7%. This dropped to 21.7% at 8-weeks. Conclusion: Patients with advanced disease have a multitude of reasons to seek acute inpatient care. The majority of the patients were discharged following care. However, the survival rate of patients following discharge was low.

Effectiveness of Nerve Blocks for the Management of Head and Neck Cancer Associated Neuropathic Pain Disorders; a Retrospective Study.

Introduction: A portion of patients with head and neck cancer (HNC)- associated pain may not experience relief in symptoms with non-invasive modalities. A nerve block is a procedure in which a local anaesthetic agent is injected along the nerve track to preferentially block sensory transmission. The literature on the effectiveness of nerve blocks in the management of HNC-related pain is limited. The purpose of this study was to determine the effectiveness of nerve blocks in the management of breakthrough HNC-associated trigeminal or cervical neuropathic pain disorders. Materials and Methods: A retrospective chart review of patients who underwent a nerve block or infiltration procedure in the regions of head and neck for the management of breakthrough HNC-associated trigeminal or cervical neuropathic pain disorders in the Orofacial Pain Medicine Clinic, Shaukat Khanum Memorial Cancer Hospital and Research Centre, between November 2018 and November 2019 was completed. Information regarding demographics, diagnosis and pain characteristics was extracted and reviewed. The Fisher's exact test and Mann-Whitney U-test were used for analysis between independent and dependent variables. Results: A total of 27 participants were included in the investigation, of which 66.7% were male. The average pre-procedure pain score was 6.85±2.54. Following intervention, 81.5% of the participants experienced >75% relief in pain for longer than 48 hours. The mean immediate post-procedure pain score was 0.26±1.02 and the average duration of relief was 6.10±6.50 weeks. The significant effect of nerve blocks was found to be statistically associated with the concurrent use of amitriptyline (P = 0.017). Conclusion: Nerve blocks, as an adjunctive therapy to pharmacologic treatment, can provide significant relief to patients with breakthrough HNC-associated trigeminal and cervical neuropathic pain disorders. However, the duration of relief experienced by the participants is inconsistent. The beneficial effect of nerve blocks appears to be more common in patients that were concurrently using amitriptyline.

Coeliac Plexus Neurolysis For Pancreatic Cancer Patients; Retrospective Analysis Of Shaukat Khanum Memorial Cancer Hospital & Research Centre Experience.

BACKGROUND: Among all the abdominal cancers, pancreatic cancer is the second most common one. Majority of the patients present with an excruciating pain when they are diagnosed with the disease. Coeliac plexus neurolysis (CPN) is a procedure that can control the pain in pancreatic cancer while precluding further consumption of analgesics in higher doses and quantity. The procedure of neurolysis is performed by injecting phenol/alcohol into the coeliac plexus ganglionic neural network. There is a high proportion of pain relief with CPN in up to 80% of the patients. AIM: The aim of our study is to assess the pain relief after CPN, reduction in analgesics consumption and evaluation of patient satisfaction post procedure. METHODS: A cross sectional study was done and we collected the retrospective data from December 2016 to November 2017. A total of 35 patients of either gender (male and female) were included in this study. Neurolysis was done with transcrural approach using 6% phenol. Follow up of patients was done after 1 and 4 weeks of the procedure. The patients were evaluated for pain scores on numeric rating scale (NRS), reduction in analgesia and patient satisfaction regarding the procedure and pain relief. The analysis was based on mean values. RESULTS: Total numbers of patients were 35. The mean age was 54.11±12.51 (SD) years with a male to female percentage of 31.43% and 68.57%. Follow up was done after 1 week and 4 weeks. Patients reported decrease in mean pain score (1 from 9 in Males and 0 from 9 in Females), reduction in analgesics (81.8% among Males and 18.2% among Females) and over all patient's satisfaction was (72.7% Males and 27.3% Females). CONCLUSIONS: It has been observed from the results that CPN works effectively for pancreatic cancer patients. There is a strong recommendation of neurolysis in patients with pancreatic cancer pain as it improves the pain scores, significant reduction in analgesia consumption with good patient satisfaction.

Outcomes of In-Hospital Cardiopulmonary Resuscitation Among Patients With Cancer.

OBJECTIVE: To review all episodes where an emergency code was called in a cancer-specialized hospital in Pakistan and to assess survival to discharge among patients who received a cardiopulmonary resuscitation (CPR). METHODS: We reviewed demographic and clinical data related to all "code blue" calls over 3 years. Multivariate logistic regression analyses were used to test the association of clinical characteristics with the primary outcome of survival to discharge. RESULTS: A total of 646 code blue calls were included in the analysis. The CPR was performed in 388 (60%) of these calls. For every 20 episodes of CPR among patients with cancer of all ages, only 1 resulted in a patient's survival to discharge, even though in 52.2% episodes there was a return of spontaneous circulation. No association was found between the type of rhythm at initiation of CPR and likelihood of survival to discharge. CONCLUSIONS: The proportion of patients with advanced cancer surviving to discharge after in-hospital CPR in a low-income country was in line with the reported international experience. Most patients with cancer who received in-hospital CPR did not survive to discharge and did not appear to benefit from resuscitation. Advance directives by patients with cancer limiting aggressive interventions at end of life and proper documentation of these directives will help in provision of care that is humane and consonant with patients' wishes for a dignified death. Patients' early appreciation of the limited benefits of CPR in advanced cancer is likely to help them formulate such advance directives.

Preferences regarding disclosure of prognosis and end-of-life care: A survey of cancer patients with advanced disease in a lower-middle-income country.

BACKGROUND: Cancer patients' preferences regarding disclosure of prognosis and end-of-life care remain under-reported from low- and middle-income countries where cancer poses an increasing demand on scarce healthcare resources. A better knowledge of these preferences can help in achievement of shared treatment goals. AIM: To survey preferences of adult cancer patients regarding disclosure of prognosis and end-of-life care DESIGN: A multidimensional questionnaire was developed to survey consecutively sampled patients. A fifth of the participants completed a repeat survey 3 months later. SETTING/PARTICIPANTS: Adult patients at a specialist cancer center in Pakistan. RESULTS: In total, 520 patients were surveyed initially (participation rate 98.6%) and 100 completed the repeat survey. Three in five respondents wanted a healthcare provider to give them detailed information about their prognosis and life expectancy. Those who wanted information withheld were significantly more likely to be female, to have a lower socioeconomic status, or to have lung cancer. Only two in five patients agreed that they wanted to die at home and more than 90% wanted all possible care till end-of-life. Yet, a little over half also agreed that they did not wish to be placed on a ventilator. In rank ordering preferences about end-of-life, respondents ranked "religious wellbeing" as the highest and "avoiding inappropriate prolongation of dying" as the lowest of six options. CONCLUSION: A majority of adult cancer patients surveyed in this study wanted a truthful disclosure about their disease prognosis and expressed a preference for hospital-based care at end-of-life. Healthcare providers should find ways to tailor prognostic information to patients' expressed information needs.

Development of palliative-care services in a developing country: Pakistan.

Palliative care services are poorly developed in most resource-poor countries. With the increase in the number of cancer cases being diagnosed in these countries, most of whom present in advanced stages, an urgent need for palliative care is emerging. Pakistan is an example of a resource-poor country where palliative care services are in the initial phase of development.

"Hands-Free" continuous echocardiography during treadmill exercise using a novel ultrasound transducer.

BACKGROUND: Echocardiographic imaging using a handheld transducer in conjunction with treadmill exercise testing is commonly used for the diagnosis of coronary artery disease. Motion of the hand and the transducer during peak exercise preclude optimal imaging. To circumvent the limitations of handheld transducers, we developed a low profile transducer (CONTISON) which can be attached to the chest wall for continuous cardiac imaging. METHODS AND RESULTS: This feasibility study was performed in 10 normal male subjects (28 to 36 years). The ultrasound transducer was placed in the third or fourth intercostal space at the left sternal border to permit imaging of the left ventricle in its short axis. The transducer was interfaced with a commercially available ultrasound machine. The left ventricle was imaged at rest and while subjects exercised according to a standard Bruce protocol. All segments of the left ventricular short axis were seen at rest and peak exercise. Increased left ventricular wall thickening and wall motion were seen at peak exercise. There were no complications from the procedure. CONCLUSION: We demonstrated the feasibility of hands-free left ventricular imaging during treadmill exercise using the CONTISON transducer. Further evaluation of the technique to detect stress-induced wall motion abnormalities, as a means of diagnosing myocardial ischemia, appears warranted. (ECHOCARDIOGRAPHY 2010;27:563-566).

A two-center study of Muslim women's views of breast cancer and breast health practices in Pakistan and the UK.

Breast health awareness practices of Pakistani Muslim women in the UK and Pakistan is unknown. Focus group interviews were used to investigate the impact of culture and psychosocial issues on breast health awareness involving 44 women in Lahore and London. Women based in Lahore were more inquisitive about breast cancer and held more developed views compared with British Pakistani Muslim women. Women concurred that concise and relevant breast health education is needed irrespective of faith to improve cultural sensitivity and awareness in both Pakistani communities (both men and women).

Documentation of resuscitation status in an ambulatory palliative care population: results of a prospective observational study from a tertiary cancer care centre in Pakistan.

BACKGROUND: It was observed in our hospital that a lot of patients with advanced progressive disease were being seen in the palliative care clinics without documentation of their resuscitation status. AIM: To assess the documentation of resuscitation in patients referred to palliative care clinic. METHODS: Retrospective review of medical records of patients referred to the palliative care clinic was done looking for evidence of documentation of code status. RESULTS: Only 77 of the 316 patients seen in clinic during this period had any documentation of code status. More than half of these had been referred by the internists who had documented the code status as well. CONCLUSIONS: As a result of the study, we have introduced changes aimed at ensuring better documentation of resuscitation status.

The impact of culture and sociological and psychological issues on Muslim patients with breast cancer in Pakistan.

Breast cancer is the most common form of cancer in Muslim women in Pakistan. The impact of the initial diagnosis, culture, religion, and psychosocial and psychological aspects of the disease is not well established. This qualitative study examined the experience and coping strategies used by patients with breast cancer in relation to its impact on their physical, mental health, religious, and family issues. Thirty patients with breast cancer were interviewed. Data were analyzed using thematic analysis. The patient's experience of breast cancer focused on the range of emotions felt throughout the illness trajectory, the importance of religion and family support on coping strategies used to manage the adverse effects of chemotherapy, and also the financial concerns. This is the first study to examine Pakistani Muslim women's views on the lived experience of breast cancer. This article provides clarification of the voiced experiences of women with breast cancer. The data not only highlight the role of religion and family support as essential coping strategies but also emphasize the issues of isolation, aggression, and anger as common responses to chemotherapy. Unique features of this study are women's need to seek spiritual support for their illness and the overriding innate characteristic of maternal responsibility. These cultural features require further analysis and research.