Incidence of noncompliance

Incidence of noncompliance with respect to the DMGs

Distribution of patients with noncompliance

Cause of noncompliance

Discussion

The literature available from our country regarding noncompliance of patients on RT is sparse, with available data focusing majorly on specific tumor types.[6] [7] [8] [9] [10] [11] The studies published globally too mention a wide range of noncompliance across institutions and regions ([Table 5]).[1] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19] [20] [21] The comparison of these results from these studies is challenging as the definition of noncompliance varies. The studies from our country show variable but high noncompliance rate across a spectrum of urban tertiary care centers, academic ones, and centers operating in rural part of the country.[6] [7] [8] [9] [10] [11] Our institute is a tertiary care center with a dedicated oncology infrastructure. Despite the large number of patients being offered RT, the noncompliance rate in our department is 2.28%, significantly less than the reported incidence in other institutes, though the definitions of noncompliance vary across studies.[1] [4] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19] [20] [21] The distribution of gender (males 112; 56.9%) was reflective of the routine registrations in the year 2019 emphasizing that there is no gender-specific predilection for noncompliance in our study. The same was true for the marital status and age of the patients. The distribution of the patients with respect to their religion was in accordance with the Indian Census 2011, underscoring the impact of diverse religions and beliefs on noncompliance in our institute.

List of publications addressing non-compliance

Illiteracy and poor socioeconomic status are associated with poor compliance.[4] Around one-third of noncompliant patients were illiterate (33%), and almost half were unemployed (53.3%). We could not capture the data on the family income. Patient registration is done in service categories depending on the economic status into general (or converted to “no-charge” category later on) and private. The distribution of category in noncompliant patients was in accordance with the routine registrations that year reflecting that no particular category patients are more noncompliant and vice versa. This could reflect on the policy to help nonaffording patients through multiple schemes running in the institute as well as in the department. The economic status of the patient could not be accurately calculated, hence not mentioned in this study. Low socioeconomic status is a statistically significant predictor of noncompliance.[11]

Our institute being a tertiary cancer care institute offering comprehensive care gets referral from all over the country as well as from overseas. This is reflected in our data as only 29.9%-belonged to Mumbai (Mumbai metropolitan region) and 18.8%-from within the state of Maharashtra. Half of the noncompliant patients were from outside the state, and five patients were from other countries. Distance between the local residence and the treating center is a known cause of noncompliance. The mean distance from the patient's place of stay in Mumbai (local residence) and our institute in our study is 20.5 km with some patients coming from places as far as 77 km away. Our institute through the medical social workers (MSWs) supports a large number of patients with short- and long-term accommodation around the institute along with to and fro transportation. We found that only nine such patients, who resided in the institute-assisted accommodation had defaulted. In the year 2019, we also referred 6,427 patients for RT outside our institute. As compared with Western countries, only one-third of Indians are covered under public or private health care insurance schemes.[22] However, barely one-tenth (9.6%) of noncompliant patients had a health insurance. Thomas et al reported almost twice treatment delays in indigent patients as compared with the insured ones essentially due to nonmedical or logistical reasons.[23]

Poor performance status, substance abuse, and presence of comorbidities are associated with nonadherence to treatment guidelines.[24] However, in our study, most of the patients (85.7%) had a performance status (Karnofsky performance status) of 80 and above at the time of issue of RT appointment, and only one-third of them had known comorbidities (65; 33%) or history of substance abuse (72; 36.5%). None of these patients were admitted in our institute while on RT. Most of the patients had locally advanced/locoregional (136; 69%) and were planned for multimodality treatment (117/197) either with definitive chemo-RT (62; 31.5%) or adjuvant RT/chemo-RT (55; 27.9%). Only 46 (23.4%) of them were planned for single modality (RT) treatment. Multimodal treatment is often associated with increased toxicity and prolonged course of treatment which may hamper the compliance to the planned treatment.[10] Choosing optimal therapy especially multimodal in locally advanced cases is of immense importance.

The incidence of noncompliance of brachytherapy patients in our study is 1.27%. Literature regarding the same is nonexistent. The 12 patients who defaulted brachytherapy were planned for either intracavitary or perineal interstitial brachytherapy for gynecological cancers. All of them defaulted immediate post-external beam radiation therapy (EBRT) except for one who defaulted post one session of brachytherapy. Most of our patients who undergo brachytherapy for breast malignancies and sarcomas are treated as inpatients, and there was no incidence of noncompliance in them.

RT is an effective modality for palliation of symptoms. Among the palliative patients who defaulted, majority of them were planned for fractionated treatments (73.9%) compared with single fraction (26%). The most common fractionated schedules were 20Gy/5Fr (34.7%) or 30Gy/10Fr (26%) in noncompliant patients. Among single fraction schedules, 10Gy/SF (17.3%) and 8Gy/SF (8.6%) were the most common. Most of these patients did not turn up for treatment at all (47.8%) or defaulted RT simulation (30.4%). The patients who defaulted after starting RT (21.7%) could not complete more than four fractions. All of these patients were planned for fractionated treatment. Among these palliative patients, majority were planned for treatment with conventional technique (73.9%) compared with conformal technique (26.1%). This emphasizes the need of shorter course of treatment for patients being treated with palliative intent.

The causes of noncompliance vary across differed regions, institutes, type of malignancy, patient population, and could be a combination of social, financial, and logistic reasons. Treatment-related toxicity is also a common cause of noncompliance; however, in our study, the patients with unplanned RT completion or gap prescribed by the treating radiation oncologist due to toxicity or other reasons were not included. Cause of noncompliance was known in around two-thirds of our patients (135; 68.5%). The most common cause of noncompliance in our patient population was the intent to take RT/complete further Rx at their native place (29; 21.5%). As mentioned earlier, most of our patients came from outside the city of Mumbai. In the year 2019, we referred 6,427 patients for RT outside TMH essentially due to the same reason. National Cancer Grid which is a network of major cancer centers across India with a planned decentralization of oncological care immensely helps our patients in receiving quality care outside TMH all over the country. Access to good quality care at or around their native place has made patients comfortable in taking treatment while being in the comfort of their homes. At times, social, logistic, and financial reasons too may compel them to abandon the treatment.[25] Comprehensive support (socioeconomic, accommodation, logistic, nutrition, transfusion, education, etc.) along with prospective tracking of noncomplaint patients has reduced the rates of noncompliance from >20 to <5 % in the pediatric oncology department of our institute. .25] Similarly, patients in our department are actively involved in support group sessions and receive assistance from dedicated MSWs with financial, logistic, and accommodation assistance. These measures could have contributed to the low incidence of noncompliance in our patients. Financial issues were seen in only one-tenth of our patients (16; 11.9%).

Rigorous patient counseling while planning for RT is imperative in ensuring confidence in the efficacy of a treatment modality, acceptance of the expected tolerance to the same and improves adherence to planned treatment protocol which may have a subsequent impact on the overall oncological outcome. The other causes of noncompliance in our study were lack of confidence in the curative potential of the treatment (23; 17.0%), fear of treatment/toxicity (7; 5.2%), and frustration due to prolonged treatment course (5; 3.7%). Optimum counseling can ameliorate these issues and improve compliance. Majority of patients who had lack of confidence in the planned oncological treatment switched to alternative treatment (especially Ayurveda). It is vital to integrate indigenous alternate therapies such as Ayurveda, Yoga, Naturopathy, etc. with the oncological plan to enhance patient's confidence in the planned therapy.

For more than a decade, the RT appointments and planning process is streamlined by the ROIS ensuring adherence to RT planning time points. Hence, the delay in starting of RT as a cause was seen in very few patients (12; 8.9%). This delay in starting RT was more of patients own perception than an actual delay in starting the planned RT. Half of our patients defaulted the scheduled simulation appointment (97; 49.2%), one-fourth did not turn up for starting RT (53; 26.9%), and remaining defaulted while on RT (47; 23.9%). The loss of man-hours in the planning process (simulation, contouring, and planning) for 100 patients (defaulted RT starting/while on RT) becomes significant for a busy department like ours. Better compliance is reported with hypofractionation versus conventional fractionation in adjuvant breast cancer RT.[26] Similarly, the lowest noncompliance rate was seen in patients with breast cancer in our study (4 patients out of 1,659; 0.2%). This could be attributed to the delivery of short course of radiation (hypofractionation) in these patients and thereby shortening of the overall treatment duration.

Our study has the limitation of its data being captured in a retrospective manner. We could not capture the financial status. Our study did not analyze the impact of noncompliance on oncological outcomes. The cause of noncompliance is not known for one-third of the patients (n = 62; 31.5%). We propose a prospective study of active tracking of noncompliant patients, further evaluating their causes of noncompliance and factors affecting the same to be followed by incorporation of mitigation measures to further reduce the incidence of noncompliance to almost nil in our patient population. Some points that come forward from our study that can be incorporated in other centers especially those with high patient throughput are mentioned herewith.

• Holistic approach toward treatment which includes all aspects of care oncological, social, financial, personal, and mental.

• Optimum counseling (individual and group) done by the clinicians and support staff which includes social workers, dieticians, etc. during individual sessions as well as during patient support group meetings.

• Red flagging of patients at high risk for noncompliance (poor social support, financial issues, advanced stage patient planned for multimodality treatment, etc.).

• Adherence to the RT time points.

• Frequent review of patients on treatment for assessment of toxicities as well as review of socioeconomic factors that may lead to noncompliance.

• Development of financial models to assure financial assistance.

• One-fifth of patients desired RT at native place/combination of personal, logistic, and financial reasons. Development of networks (National Cancer Grid) or collaborative groups to encourage decentralization of services and ensure optimum continuum of cancer care.

• Gainful employment/vocational rehabilitation for posttreatment to improve self-sustenance.

Conclusion

The incidence of noncompliance in patients planned for RT in our institute can be considered optimum. Appropriate counseling of patients at the time of scheduling appointment, upfront identification of patients at high risk of noncompliance, and assisting patients with financial and logistic challenges are imperative to ensure adherence to planned treatment schedule.

Conflict of Interest

None declared.

Acknowledgment

The authors would like to acknowledge residents and fellows of the Department of Radiation Oncology, Tata Memorial Centre, Mumbai, India.

Note

The manuscript has been read and approved by all the authors, the requirements for authorship have been met, and that each author believes that the manuscript represents honest work.

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Publication History

Article published online:
27 February 2022

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