Quality of Care for Prostate Cancer in Kashmir, India: A Real-World Study

Purpose Despite the importance of quality care for patients with prostate cancer, significant gaps exist in healthcare delivery, including diagnosis and treatment. Our objective was to assess the quality of care (QoC) using retrospective data from prostate care patients in our center. Methods We performed a retrospective study of prostate cancer patients registered at a dedicated cancer care center in the Kashmir region from 2012 to 2020. A set of 15 quality indicators representing crucial facets of diagnosis, pathology, and treatment was identified from a comprehensive list developed and validated by other researchers. Results The final analysis of all indicators was conducted on 46 patients with a median age of 70 years (52-92 years). In the majority of patients, the diagnosis (89.1%) was made through a prostatic biopsy, while only five patients were diagnosed solely based on the prostate-specific antigen. Transrectal ultrasound (TRUS) or transurethral resection (TURP)-guided biopsy was documented in 84.8% of patients, with Gleason grading documented in 87.5% of patients. However, the number of positive cores was mentioned for only 25.7% of patients. Radical prostatectomy was the primary treatment for most patients with localized prostate cancer (58.3%). The majority of patients with metastatic prostate cancer were treated with orchidectomy (55%), owing to easy access and the lower cost of surgical castration. Conclusion The study demonstrated a lack of compliance with many QoC indicators at the diagnostic and therapeutic levels. However, large-scale, population-based studies are needed to establish the compliance of prostate cancer QoC in Kashmir. The quality indicator assessment can guide the necessary actions required to improve QoC for prostate cancer patients.


Introduction
Kashmir is a landlocked area in the Himalayas, known as the paradise on Earth. There is scarce information on cancer epidemiology and the burden of cancer in Kashmir. Most of the data available is from singlecenter hospital-based studies. The most common cancers in Kashmir include the stomach, esophagus, lung, breast, and colorectal cancers [1,2]. Prostate cancer (PC) constitutes around 2.1%-2.5% of all cancers [2,3].
Recently, attention has been paid to the quality of care for cancer patients. Although newer treatments or diagnostic processes are available, evidence suggests that they do not necessarily result in optimum care for cancer patients. Furthermore, increasing data indicates that care for cancer patients may be underused or overdone. Thus, the assessment of the quality of care (QoC) is a matter of concern both for healthcare providers and healthcare recipients [4,5].
QoC studies can typically assess the quality of care provided at the societal level, providing an accurate picture of the regional care pattern, free of sample bias. This could be done using the information from the cancer registries [6]. It is possible to document the quality of treatment delivered and offer regular feedback to healthcare professionals and decision-makers through specific quality indicators (QI), which are used for QoC studies [6]. The QoC can be broadly evaluated based on three categories of QI, viz., structure, process, and outcome indicators [7]. The quality of the technical process is of high significance. It assesses whether the right choices are made in diagnosis and treatment and whether care is provided effectively and skillfully. The process indicators that have been scientifically proven to improve outcomes are the best indicators to assess the quality of care [8].
However, the concept of cancer care quality is becoming broader and incorporates outcome measures, patient preferences, and proper communication between the treating physician and patients. Experts suggest that the delivery of high-quality care for cancer patients is important to ensure optimal outcomes, but it is also challenging to measure [9].
This study aimed to retrospectively assess the results of some process-related QI related to the diagnosis and treatment of PC patients. These patients visited Hakim Sanaullah Specialist Hospital and Cancer Center (HSSHCC), Sopore, or its satellite center in Srinagar, from 2012 to 2020. The QI assessment will serve to evaluate the QoC provided to PC patients at the regional level, in areas with standardized legal, medical, and geographic characteristics.

Study population
This retrospective study identified PC patients from the hospital database. Eligible patients were men who were diagnosed with PC from 2012 to 2020 and were registered at Hakim Sanaullah Specialist Hospital and Cancer Center (HSSHCC), Sopore, Kashmir, or its satellite center, Dr. Shad Salim's Oncology Center in Srinagar, Kashmir, India. The patients were diagnosed or registered for follow-up or palliative care at HSSHCC, Sopore, or the satellite center in Srinagar. The patients registered for follow-up or palliative care had received initial care in other healthcare facilities. At the time of registration at HSSHCC, Sopore, or the satellite center, all such patients were expected to present documentation of their prior clinical contacts, admission information, investigations, and interventions. This retrospective study was approved by the Institutional Ethics Committee of the hospital (Approval No. IEC/2021-02/21.7.21). Patient consent was waived as this was a retrospective chart review and patient data was anonymous.

Data collection
The details of the patients who were included in the study were extracted from their charts. These data included detailed reports of their previous clinical visits, investigations, and interventions.
A set of QI representing crucial facets of the care given to patients diagnosed with PC was used by our research team, encompassing the clinical domains of diagnosis, pathology, and treatment. The QI were selected from a comprehensive list developed and validated by other researchers [6,10,11]. Further, the staging of the disease was registered based on the American Joint Committee on Cancer (AJCC) staging manual (8th edition) [12]. A proforma was developed based on these QIs, and data was extracted from the case records of the patients. Researchers collected the required information directly from the patient's case records, preventing erroneous interpretations and enabling the uniform codes required to reach a high degree of comparability. All the patient data was anonymized.
A total of 15 indicators were selected for analysis, including five for diagnosis, four for pathology, and six for treatment. All the information needed for these QIs was already present in the medical records of eligible patients. A numerator, the number of patients who met the precise criteria, and a denominator, the number of eligible patients, were used to define each QI. The frequency of each QI was calculated as a percentage by entering the data into an Excel spreadsheet (MS Excel, MS Office 365, Microsoft, Redmond, WA).

Results
A total of 57 patients were identified who were registered for PC between 2012 and 2020. The demographic details of these patients are described in Table 1. The average age of the patients was 70 ± 9.6 years (mean ± standard deviation). Most of the patients lived in urban areas (37/57, 64.9%). However, since detailed records for 11 patients were not available, they were excluded from further analysis. The final analysis included data from 46 patients ( Figure 1).

Characteristic
Number of patients n (%)

Quality indicators for pathology
The pathological type of PC was available for 42 patients, while the data for four patients did not indicate the pathological type of cancer. The majority of patients had conventional adenocarcinoma (33/46, 71.7%) as the histopathological type ( Table 1). Based on the World Health Organization (WHO) definition [13], the histological features of the tumor were detailed in the pathology reports (TRUS or TURP) in only five patients (5/40, 12.5%), and the Gleason grading system for histology was followed in 35 patients (35/40, 87.5%).
Out of the 35 patients who had TRUS-guided biopsy, the number of cores was documented in 14 patients (14/35, 40%), and the number of positive cores was mentioned in nine patients (9/35, 25.7%). The proportion of tissue involved was not mentioned in any of the patients who had TURP.

Discussion
This retrospective study evaluated the quality of PC care. The study made it possible to assess the QoC for PC and identify any potential gaps therein. This study confirms the feasibility of collecting data from medical records to assess the quality of cancer care, as reported earlier [14,15]. Direct information extraction from the original patient records ensures uniform coding and a high level of integrity [6]. The strengths of this study include the selection of the QI developed by the Delphi method by international experts and groups [6,10,11] and the direct extraction of information from the original medical documentation, removing any sample bias.
While a family history of cancer was recorded in more than 50% of our patients and found to be positive in around 30%, a history of PC in the family had not been recorded. Most of our patients received initial treatment in other hospitals, which is indicative of access to healthcare facilities in a predominantly rural, agrarian region. It can be inferred that patients were aware that their disease had treatment options available in hospitals, implying a level of healthcare awareness.
In our study, only five patients reported a DRE. This may indicate poor documentation or reduced reliance on this parameter for clinical diagnosis. Moreover, as per records, 10.8% of patients were given a PC diagnosis only based on PSA.
The diagnosis must be histologically validated to achieve precise grading of the tumor and improved treatment planning [16]. Most of the patients in our study were diagnosed through a biopsy, which conforms with studies conducted in Victoria and South Australia as well as Switzerland [6,17]. For optimal management of PC patients, the information reported in the biopsy pathology reports is of paramount importance. Guidelines published by international organizations like the European Association of Urology suggest that the pathology report of prostatic biopsies should include tumor histology, Gleason score, and quantification of tissue involved in the tumor [18]. The Gleason score was documented in the majority of our patients (85%); however, the histological features and quantification of tissue involvement were less documented. None of the TURP patients and <30% of TRUS patients had quantification of tissue involved by the tumor documented, while histology according to WHO classification was reported in only five patients. This reporting was found to be very low compared to other studies conducted in Switzerland [6].
In our study, most of the patients were diagnosed by a TRUS-guided biopsy (73.9%), and 10.8% had the diagnosis confirmed by TURP. Studies from other countries have also reported similar results [6,17,19].
International guidelines recommend taking a minimum of eight to 12 cores under guidance [18,20,21]. In our study, among the patients with a documented number of cores at TRUS biopsy, only six patients (6/14, 42.8%) had eight or more biopsy cores. As compared to data from other studies where the proportion of patients having more than eight cores taken was more than 70%, this is a much smaller number [6,19,22].
Active surveillance, radical prostatectomy with lymph node dissection, RT, and HT are established methods of treating localized PC [18]. The choice of treatment depends on the risk, patient preference, and physicians' choice. The number of patients undergoing radical prostatectomy (7/12, 58.3%) was similar to that reported by other studies [6,17]. None of the patients in this group underwent RT for localized disease, probably due to limited access to RT and the desire for quick treatment as opposed to multiple-stage treatment. No referrals for RT were made in this group.
In metastatic PC, treatment aims to prevent the progression of the disease, improve quality of life, and attempt to prolong survival [18]. Either surgical or medical ADT is the treatment of choice for patients with metastatic PC. Recently, the addition of other agents like docetaxel, abiraterone, enzalutamide, or apalutamide has been shown to improve outcomes in patients with high-risk castration-sensitive PC [23]. The use of surgical castration is decreasing despite potential advantages like low cost, equal oncological outcomes, and better non-oncological outcomes. In a recent retrospective study, more men with limited healthcare access underwent orchidectomy [24]. A similar trend was also observed in our study, with orchidectomy being the most frequent intervention (20/36, 55%). Easy access to surgery and lower costs make it a preferable option in countries with limited resources.
Patients with PC are more likely to have increased bone fragility and low bone mineral density [25]. The use of ADT has been associated with bone loss, increasing the risk of skeletal-related events. The prevention of skeletal-related events is an important goal for patients with prostatic cancer [25,26]. Several guidance documents recommend bone mineral density testing before starting ADT [21,27]. In patients with a high risk of fracture, bone-strengthening agents are recommended. In patients with castration-resistant PC and skeletal metastasis, denosumab or zoledronic acid should be used [28,29]. Low utilization of DEXA scans during therapy and bone health interventions is an important lacuna in the management of our patients.
One of the limitations of our study is its small size and the missing data on some patients. Moreover, another limitation, as reported by other studies, is the involvement of multiple specialists in the management of these patients [30]. This is because many patients in our study group received their initial treatment at different institutions. Furthermore, it is not a population-based study, so the findings cannot be generalized. The reasons for the lack of use of RT for localized disease in our group were not studied. The study did not take into account the actual literacy status and educational levels of the population being studied. It is a well-known fact that literacy status impacts access to and utilization of healthcare facilities.

Conclusions
The current study reveals a lack of compliance for many QoC indicators for PC patients in the study population. The study shows that QI for diagnosis and treatment can be assessed by retrospective chart review, which may help improve therapeutic safety and effectiveness. This will in turn lower variation in care and, thus, enhance patient outcomes. Dissemination of information regarding guidelines for prostate cancer treatment, quality control indicators, and available options for treatment through digital and print media is recommended to plug knowledge gaps that impact healthcare in this region.

Additional Information Disclosures
Human subjects: Consent was obtained or waived by all participants in this study. Institutional ethics committee of Hakim Sanaullah Specialist Hospital and Cancer Center (HSSHCC), Sopore, issued approval IEC/2021-02/21.7.21. The IEC has granted approval for the study with following conditions: 1. All identifier data shall be anonymized 2. Please include the name of all authors and the affiliation of HSSHCC in the final paper. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.