Tag Archive for: patient-reported outcomes

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Article of the week: Patient‐reported outcomes in a phase 2 study comparing atezolizumab alone or with bevacizumab vs sunitinib in previously untreated metastatic renal cell carcinoma

Every week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

If you only have time to read one article this week, we recommend this one. 

Patient‐reported outcomes in a phase 2 study comparing atezolizumab alone or with bevacizumab vs sunitinib in previously untreated metastatic renal cell carcinoma

Sumanta K. Pal*, David F. McDermott, Michael B. Atkins, Bernard Escudier§, Brian I. Rini, Robert J. Motzer**, Lawrence Fong††, Richard W. Joseph‡‡, Stephane Oudard§§, Alain Ravaud¶¶, Sergio Bracarda***, Cristina Suárez†††, Elaine T. Lam‡‡‡, Toni K. Choueiri§§§, Beiying Ding¶¶¶, Caroleen Quach¶¶¶, Kenji Hashimoto****, Christina Schiff¶¶¶, Elisabeth Piault-Louis¶¶¶ and Thomas Powles††††

*Department of Medical Oncology and Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA, §Gustave Roussy, Villejuif, France, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, **Memorial Sloan Kettering Cancer Center, New York, NY, ††School of Medicine, University of California, San Francisco, San Francisco, CA, ‡‡Mayo Clinic Hospital, Jacksonville, FL, USA, §§Department of Medical Oncology, Georges Pompidou Hospital, Paris Descartes University, Paris, ¶¶CHU Hôpitaux de Bordeaux, Hôpital Saint-André, Bordeaux, France, ***Azienda Ospedaliera S. Maria, Terni, Italy, †††Vall d’Hebron University Hospital and Institute of Oncology, Barcelona, Spain, ‡‡‡Anschutz Medical Campus, University of Colorado, Aurora, CO, §§§Dana-Farber Cancer Institute, Boston, MA, ¶¶¶Genentech, Inc., South San Francisco, CA, USA,****Roche Products Ltd, Welwyn Garden City, and ††††Barts Cancer Institute, Royal Free Hospital, Queen Mary University of London, London, UK

Abstract

Objective

To evaluate patient‐reported outcome (PRO) data from the IMmotion150 study. The phase 2 IMmotion150 study showed improved progression‐free survival with atezolizumab plus bevacizumab vs sunitinib in patients with programmed death‐ligand 1 (PD‐L1)+ tumours and suggested activity of atezolizumab monotherapy in previously untreated metastatic renal cell carcinoma (mRCC).

Patients and methods

Patients with previously untreated mRCC were randomised to atezolizumab 1200 mg intravenously (i.v.) every 3 weeks (= 103), the atezolizumab regimen plus bevacizumab 15 mg/kg i.v. every 3 weeks (= 101), or sunitinib 50 mg orally daily (4 weeks on, 2 weeks off; = 101). The MD Anderson Symptom Inventory (MDASI) and Brief Fatigue Inventory (BFI) were administered on days 1 and 22 of each 6‐week cycle. Time to deterioration (TTD), change from baseline in MDASI core and RCC symptom severity, interference with daily life, and BFI fatigue severity and interference scores were reported for all comers. The TTD was the first ≥2‐point score increase over baseline. Absolute effect size ≥0.2 suggested a clinically important difference with checkpoint inhibitor therapy vs sunitinib.

Fig.3. Change in individual symptom severity during first‐line treatment based on MDASI. Atezo, atezolizumab; bev, bevacizumab; ES, effect size; MDASI, MD Anderson Symptom Inventory. aES ≤−0.20 favouring atezolizumab alone vs sunitinib. bES ≤−0.20 favouring atezolizumab plus bevacizumab vs sunitinib.

Results

Completion rates were >90% at baseline and ≥80% at most visits. Delayed TTD in core and RCC symptoms, symptom interference, fatigue, and fatigue‐related interference was observed with atezolizumab (both alone and in combination) vs sunitinib. Improved TTD (hazard ratio [HR], 95% confidence interval [CI]) was more pronounced with atezolizumab monotherapy: core symptoms, 0.39 (0.22–0.71); RCC symptoms, 0.22 (0.12–0.41); and symptom interference, 0.36 (0.22–0.58). Change from baseline by visit, evaluated by the MDASI, also showed a trend favouring atezolizumab monotherapy vs sunitinib. Small sample sizes may have limited the ability to draw definitive conclusions.

Conclusion

PROs suggested that atezolizumab alone or with bevacizumab maintained daily function compared with sunitinib. Notably, symptoms were least severe with atezolizumab alone vs sunitinib (IMmotion150; ClinicalTrials.gov Identifier: NCT01984242).

Residents’ Podcast: CUA 2018 review

Jesse Ory and Andrea Kokorovic
Department of Urology, Dalhousie University, Halifax, NS, Canada

Dalhousie residents Jesse Ory and Andrea Kokorovic sum up the highlights of day 1 at the 2018 Canadian Urological Association annual meeting in Halifax

Song credits
Don’t fear the reaper: Blue oyster cult
Mute city: F Zero
Mortal Kombat Theme: The Immortals
Funky Suspense – Bensound.com

BJUI Podcasts now available on iTunes, subscribe here https://itunes.apple.com/gb/podcast/bju-international/id1309570262

 

 

Article of the Month: Patient reported “ever had” and “current” long term physical symptoms following prostate cancer treatments

Every Month the Editor-in-Chief selects the Article of the Month from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Month heading on the homepage will consist of additional material or media. This week we feature a video from Dr. Anna Gavin discussing his paper. 

If you only have time to read one article this week, it should be this one.

Patient reported “ever had” and “current” long term physical symptoms following prostate cancer treatments.

Anna T. Gavin, Frances J. Drummond*, Conan Donnelly, Eamonn O’Leary*, Linda Sharp† and Heather R. Kinnear

Northern Ireland Cancer Registry, Centre for Public Health, Queen’s University Belfast, Mulhouse Building, Belfast Northern Ireland, UK, *National Cancer Registry Ireland, Building 6800, Airport Business Park Cork, Ireland, and †Institute of Health and Society, Newcastle University, Richardson Road, Newcastle upon Tyne, NE2 4AX, England, UK

 

Read the full article

OBJECTIVE

To investigate the prevalence of physical symptoms that were ‘ever’ and ‘currently’ experienced by survivors of prostate cancer at a population level, to assess burden and thus inform policy to support survivors.

PATIENTS AND METHODS

The study included 3 348 men surviving prostate cancer for 2–18 years after diagnosis. A cross-sectional, postal survey of 6 559 survivors diagnosed 2–18 years ago with primary, invasive prostate cancer (ICD10-C61) identified via national, population-based cancer registries in Northern Ireland and Republic of Ireland. Questions included symptoms at diagnosis, primary treatments and physical symptoms (erectile dysfunction [ED]/urinary incontinence [UI]/bowel problems/breast changes/loss of libido/hot flashes/fatigue) experienced ‘ever’ and at questionnaire completion (‘current’). Symptom proportions were weighted by age, country and time since diagnosis. Bonferroni corrections were applied for multiple comparisons.

RESULTS

Adjusted response rate 54%; 75% reported at least one ‘current’ physical symptom (‘ever’ 90%), with 29% reporting at least three. Prevalence varied by treatment. Overall, 57% reported current ED and this was highest after radical prostatectomy (RP, 76%) followed by external beam radiotherapy with concurrent hormone therapy (HT, 64%). UI (overall ‘current’ 16%) was highest after RP (‘current’ 28%; ‘ever’ 70%). While 42% of brachytherapy patients reported no ‘current’ symptoms, 43% reported ‘current’ ED and 8% ‘current’ UI. ‘Current’ hot flashes (41%), breast changes (18%) and fatigue (28%) were reported more often by patients on HT.

CONCLUSION

Symptoms after prostate cancer treatment are common, often multiple, persist long-term and vary by treatment method. They represent a significant health burden. An estimated 1.6% of men aged >45 years are survivors of prostate cancer and currently experiencing an adverse physical symptom. Recognition and treatment of physical symptoms should be prioritised in patient follow-up. This information should facilitate men and clinicians when deciding about treatment as differences in survival between radical treatments is minimal.

Read more articles of the week

Editorial: Hot topic of cancer survivorship and the ‘seven deadly sins’

Cancer survivorship has become a hot topic as overall mortality for most cancer patients continues to decrease, the worldwide population continues to age and as patients become more information savvy [1-3]. Gavin et al. [4] provide a data-rich population-based patient survey of seven of the most common physical symptoms after prostate cancer treatment. While we, as urologists and prostate cancer providers, may not be able to recount the seven deadly sins or the seven dwarfs, we do know these seven symptoms: impotence; incontinence; bowel problems; fatigue; hot flushes; loss of libido; and breast symptoms. Urological surgeons and radiation oncologists talk to patients every day about the ‘big three’ of these: impotence, incontinence and bowel problems. Gavin et al. provide the striking statistic that ~1.6% of the male population over the age of 45 years is a prostate cancer survivor currently living with one of the seven.

The paper describes mailed survey results from a population-based cohort of 3 348 prostate cancer survivors 2–15 years after diagnosis with a response rate of 54%. The average age of respondents was 64.9 years, 64% had localized disease at presentation, 65% had Gleason 5–7 disease, and 48, 32 and 20% were surveyed 2–4.9, 5–9.9 and >10 years after diagnosis, respectively. The paper is chock full of descriptive statistics about rates of past and ongoing side effects of the various treatments and essentially has ‘something for everyone’. For example, at baseline before treatment, 51.2% of respondents reported urinary frequency, 18.8% reported impotence and 14.7% reported loss of libido. These data may be useful for estimating population-based general men’s health disease. After treatment, radical prostatectomy (RP) had the highest rates of impotence (76% current) and incontinence (current 28%; ever 70%); however, the authors examined radiation plus hormonal therapy and found impotence rates of 64% and rates of hot flushes, breast changes and bowel problems in the 20–27% range. Table 3 and Figs 3 and 4 in the paper are particularly useful to further examine the seven side effects with treatment.

On the one hand, these data could be useful in educating patients about treatment options for prostate cancer and what they might expect should they choose one treatment over another. Ideally, this education would occur in the multidisciplinary clinic setting [5]. On the other hand, these data could also be used in the wrong way. For example, an aggressive surgeon could selectively present the ‘deadly downsides’ of radiation while downplaying the ‘surgical sins’, whereas a radiation oncologist could do just the opposite to try to influence his or her patients. This highlights the limitations of the present study. While the authors are to be congratulated for a wonderful population-based survey, no control group was surveyed and, more importantly, the authors do not address satisfaction and regret. In other words, the seven side effects must be placed into the patient’s overall satisfaction regarding cancer control and the patient’s ‘trade-offs individualized internal assessment’. For example, our group examined satisfaction and regret after open and robot-assisted RP, finding an ~80–85% satisfaction rate despite levels of impotence and incontinence slightly lower but similar to those in the present population-based survey [6]. While patients who underwent open RP enjoyed more satisfaction and less regret, we attributed much of this to the ‘used car salesman’ approach to ‘selling’ robot-assisted RP in the last decade [7]. In other words, we hypothesized that patients undergoing robot-assisted RP were misled into believing the robot would lessen or eliminate the surgical sins while those undergoing open RP were counselled more realistically. Also, we found that in multivariable analysis, African-American patients exhibited more regret [6]. These data point to the fact that the present study from Ireland may not be applicable to other populations, particularly those with a mixed or different ethnic make-up. Another limitation to population-based data is the impact of centres of excellence and highly experienced treatment providers. The impact of high-volume surgeons/providers on treatment outcomes is now being recognized as a critical variable that is rarely accounted for in case series, multicentre studies or population data as seen here.

Overall, Gavin et al. are to be commended for a very rich source of side effect data for a large population-based cohort of prostate cancer survivors. The ‘seven deadly sins’ of possible side effects/complications of prostate cancer treatment should be shared openly and honestly with our patients. Furthermore, physicians and healthcare systems must be encouraged to collect provider and system-specific data to better fine-tune our pre-treatment counselling that will ultimately improve the satisfaction of our cancer survivors.

Read the full article

Judd W. Moul
Duke Cancer Institute, Durham, NC, USA

 

References

1 Resnick MJ, Lacchetti C, Bergman J et al. Prostate cancer survivorship care guideline: American society of clinical oncology clinical practice guideline endorsement. J Clin Oncol 2015; 33: 1078–85

2 Skolarus TA, Wolf AM, Erb NL et al. American Cancer Society prostate cancer survivorship care guidelines. CA Cancer J Clin 2014; 64: 225–49; Erratum in: CA Cancer J Clin. 2014; 64: 445

3 Gupta S, Peterson AC. Stress urinary incontinence in the prostate cancer survivor. Curr Opin Urol 2014; 24: 395–400

4 Gavin A, Drummond F, Donnelly C, O’Leary E, Sharp L, Kinnear H. Patient reported ‘ever had’ and ‘current’ long-term physical symptoms following prostate cancer treatments. BJU Int 2015.

5 Stewart SB, Ba~nez LL, Robertson CN et al. Utilization trends at a multidisciplinary prostate cancer clinic: initial 5-year experience from the Duke Prostate Center. J Urol 2012; 187: 103–8

6 Schroeck FR, Krupski TL, Sun L et al. Satisfaction and regret after open retropubic or robot-assisted laparoscopic radical prostatectomy. Eur Urol 2008; 54: 785–93

7 Schroeck FR, Krupski TL, Stewart SB et al. Pretreatment expectations of patients undergoing robotic assisted laparoscopic or open retropubic radical prostatectomy. J Urol 2012; 187: 894–8

 

Video: Patient-reported long-term physical symptoms after prostate cancer treatments

Patient reported “ever had” and “current” long term physical symptoms following prostate cancer treatments.

To investigate the prevalence of physical symptoms that were ‘ever’ and ‘currently’ experienced by survivors of prostate cancer at a population level, to assess burden and thus inform policy to support survivors. The study included 3 348 men surviving prostate cancer for 2-18 years after diagnosis. A cross-sectional, postal survey of 6 559 survivors diagnosed 2-18 years ago with primary, invasive prostate cancer (ICD10-C61) identified via national, population-based cancer registries in Northern Ireland and Republic of Ireland. Questions included symptoms at diagnosis, primary treatments and physical symptoms (erectile dysfunction [ED]/urinary incontinence [UI]/bowel problems/breast changes/loss of libido/hot flashes/fatigue) experienced ‘ever’ and at questionnaire completion (‘current’). Symptom proportions were weighted by age, country and time since diagnosis. Bonferroni corrections were applied for multiple comparisons.

Adjusted response rate 54%; 75% reported at least one ‘current’ physical symptom (‘ever’ 90%), with 29% reporting at least three. Prevalence varied by the diverse treatments found at https://www.ukmeds.co.uk/finasteride. Overall, 57% reported current ED and this was highest after radical prostatectomy (RP, 76%) followed by external beam radiotherapy with concurrent hormone therapy (HT, 64%). UI (overall ‘current’ 16%) was highest after RP (‘current’ 28%; ‘ever’ 70%). While 42% of brachytherapy patients reported no ‘current’ symptoms, 43% reported ‘current’ ED and 8% ‘current’ UI. ‘Current’ hot flashes (41%), breast changes (18%) and fatigue (28%) were reported more often by patients on HT.

Anna T. Gavin, Frances J. Drummond*, Conan Donnelly, Eamonn O’Leary*, Linda Sharp† and Heather R. Kinnear

Northern Ireland Cancer Registry, Centre for Public Health, Queen’s University Belfast, Mulhouse Building, Belfast Northern Ireland, UK, *National Cancer Registry Ireland, Building 6800, Airport Business Park Cork, Ireland, and †Institute of Health and Society, Newcastle University, Richardson Road, Newcastle upon Tyne, NE2 4AX, England, UK

 

Read the full article

OBJECTIVE

To investigate the prevalence of physical symptoms that were ‘ever’ and ‘currently’ experienced by survivors of prostate cancer at a population level, to assess burden and thus inform policy to support survivors.

PATIENTS AND METHODS

The study included 3 348 men surviving prostate cancer for 2–18 years after diagnosis. A cross-sectional, postal survey of 6 559 survivors diagnosed 2–18 years ago with primary, invasive prostate cancer (ICD10-C61) identified via national, population-based cancer registries in Northern Ireland and Republic of Ireland. Questions included symptoms at diagnosis, primary treatments and physical symptoms (erectile dysfunction [ED]/urinary incontinence [UI]/bowel problems/breast changes/loss of libido/hot flashes/fatigue) experienced ‘ever’ and at questionnaire completion (‘current’). Symptom proportions were weighted by age, country and time since diagnosis. Bonferroni corrections were applied for multiple comparisons.

RESULTS

Adjusted response rate 54%; 75% reported at least one ‘current’ physical symptom (‘ever’ 90%), with 29% reporting at least three. Prevalence varied by treatment. Overall, 57% reported current ED and this was highest after radical prostatectomy (RP, 76%) followed by external beam radiotherapy with concurrent hormone therapy (HT, 64%). UI (overall ‘current’ 16%) was highest after RP (‘current’ 28%; ‘ever’ 70%). While 42% of brachytherapy patients reported no ‘current’ symptoms, 43% reported ‘current’ ED and 8% ‘current’ UI. ‘Current’ hot flashes (41%), breast changes (18%) and fatigue (28%) were reported more often by patients on HT.

CONCLUSION

Symptoms after prostate cancer treatment are common, often multiple, persist long-term and vary by treatment method. They represent a significant health burden. An estimated 1.6% of men aged >45 years are survivors of prostate cancer and currently experiencing an adverse physical symptom. Recognition and treatment of physical symptoms should be prioritised in patient follow-up. This information should facilitate men and clinicians when deciding about treatment as differences in survival between radical treatments is minimal.

Read more articles of the week

Article of the Week: Assessing prostate cancer brachytherapy using patient-reported outcomes

Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Dr. James Talcott discussing his paper. 

If you only have time to read one article this week, it should be this one.

Using Patient-Reported Outcomes to Assess and Improve Prostate Cancer Brachytherapy

James A. Talcott 1, 2, 10, 11, Judith Manola 3, Ronald C. Chen 4, Jack A. Clark 5, 6, Irving Kaplan 7, 8, Anthony V. D’Amico 8, 11 and Anthony L. Zietman 9, 11

1 Massachusetts General Hospital Cancer Center, Boston, MA, 2 Continuum Cancer Centers of New York, New York, NY, 3 Dana-Farber Cancer Institute, Boston, MA, 4 Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, 5 Center for Health Quality, Outcomes, and Economic Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, 6 Boston University School of Public Health, 7 Beth Israel-Deaconess Medical Center, 8 Brigham and Women’s Hospital, 9 Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA, 10 Albert Einstein School of Medicine, New York, NY, and 11 Harvard Medical School, Boston, MA, USA

Read the full article

OBJECTIVE
  • To describe a successful quality improvement process that arose from unexpected differences in control groups’ short-term patient-reported outcomes (PROs) within a comparative effectiveness study of a prostate brachytherapy technique intended to reduce urinary morbidity.
PATIENTS AND METHODS
  • Patients planning prostate brachytherapy at one of three institutions were enrolled in a prospective cohort study.
  • Patients were surveyed using a validated instrument to assess treatment-related toxicity before treatment and at pre-specified intervals.
  • Unexpectedly, urinary PROs were worse in one of two standard brachytherapy technique control populations (US-BT1 and US-BT2). Therefore, we collaboratively reviewed treatment procedures, identified a discrepancy in technique, made a corrective modification, and evaluated the change.
RESULTS
  • The patient groups were demographically and clinically similar.
  • In the first preliminary analysis, US-BT2 patients reported significantly more short-term post-treatment urinary symptoms than US-BTpatients.
  • The studies treating physicians reviewed the US-BT1 and US-BT2 treatment protocols and found that they differed in whether they used an indwelling urinary catheter.
  • After adopting the US-BT1 approach, short-term urinary morbidity in US-BT2 patients decreased significantly. Brachytherapy procedures were otherwise unchanged.
CONCLUSION
  • Many procedures in cancer treatments are not evaluated, resulting in practice variation and suboptimal outcomes. Patients, the primary medical consumers, provide little direct input in evaluations of their care.
  • We used PROs, a sensitive and valid measure of treatment-related toxicity, for quality assessment and quality improvement (QA/QI) of prostate brachytherapy. This serendipitous patient-centred QA/QI process may be a useful model for empirically evaluating complex cancer treatment procedures and for screening for substandard care.

Read more articles of the week

Editorial: Patient-reported outcomes – a force for clinical improvement or another way for ‘big brother’ to survey clinicians?

In the 19th century Lord Kelvin wrote, ‘If you cannot measure it, you cannot improve it’. Since then clinical improvement has often been about measuring outcomes to determine what elements of healthcare are working well and what can be improved. The early studies of antisepsis and surgical technique had endpoints, which were measured by doctors deciding whether a wound infection, cancer recurrence or even death had occurred. These outcomes were usually discrete with little room for describing states between success and failure.

In this era whether the patient perceived that the treatment had been successful or not was irrelevant to the ‘success’ of treatment providing that the medical world agreed that the treatment had been a success. As treatments have become more established and the medical and pharmaceutical world has become more patient focussed, interest has increased in how patients report the outcome of treatment, often using questionnaires.

The pioneers of this work were mainly psychiatrists concerned about patient anxiety and depression [1] and clinical oncologists, aware that multimodal chemoradiotherapy treatments, which might in many cases be offered with palliative rather than curative intent, had the potential to cause a net loss in quality of life even if patients lived a short time longer on treatment.

As these patient-reported outcome measures (PROMs) became more commonly used in clinical trials, their focus has extended to quite specific outcomes, such that in the current era it is unusual to see papers on LUTS or erectile function presented that do not use validated PROMs, such as the IPSS [2] or International Index of Erectile Function (IIEF) [3].

The current era of research is starting to make new use of the data sources that are useful both as absolute values relating to the severity of symptoms but also particularly in measuring change in level of symptoms. Hard outcomes, such as death from cancer, have been found to be related to patient reported quality of life at presentation [4].

Clinicians are now starting to develop the necessary skills to analyse PROMs. In this setting Talcott et al. [5] have used PROM data to identify unexpected variances in symptomatic outcome after prostate brachytherapy. This was an unexpected post hoc analysis of a difference in outcomes between the two control groups in a study. It found that there was a significant difference in outcome between patients who had received an implant in two centres, which might have been expected to have similar outcomes. Analysis of differences in the implant technique in the two institutions suggested that the use of a urethral catheter to clearly visualise the urethra might be the difference and modification of this part of the technique resulted in similar PROMS outcomes in both institutions.

This is a novel quality improvement approach, which may become more widespread as institutions more frequently collect, analyse and present their PROMS. The bio-informatics skills needed to analyse this type of data meaningfully may become a greater part of everyday practice in the modern era, especially for the ‘index’ most common operations in surgical specialities. It would be interesting to see what a similar approach would produce if variance in PROMs after transurethral prostate surgery were analysed between centres in the UK and USA. Organisations with a track record for effective data analysis and reporting such as Dr Foster will be watching this evolve.

Read the full article

Alastair Henderson

Maidstone and Tunbridge Wells NHS Trust, Department of Urology, Maidstone Hospital, Maidstone, Kent, UK

References

1 Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiat Scand 1983; 67: 361–70

2 Barry MJ, O’Leary MP. Advances in benign prostatic hyperplasia. The developmental and clinical utility of symptom scores. Urol Clin North Am 1995; 22: 299–307

3 Cappelleri JC, Rosen RC, Smith MD, Mishra A, Osterloh IH. Diagnostic evaluation of the erectile function domain of the International Index of Erectile Function. Urology 1999; 54: 346–51

4 Montazeri A. Quality of life data as prognostic indicators of survival in cancer patients: an overview of the literature from 1982 to 2008. Health Qual Life Outcomes 2009; 7: 102

5 Talcott JA, Manola J, Chen RC et al. Using patient-reported outcomes to assess and improve prostate cancer brachytherapy. BJU Int 2014; 114: 511–6

Video: PROs in Prostate Brachytherapy

Using Patient-Reported Outcomes to Assess and Improve Prostate Cancer Brachytherapy

James A. Talcott 1, 2, 10, 11, Judith Manola 3, Ronald C. Chen 4, Jack A. Clark 5, 6, Irving Kaplan 7, 8, Anthony V. D’Amico 8, 11 and Anthony L. Zietman 9, 11

1 Massachusetts General Hospital Cancer Center, Boston, MA, 2 Continuum Cancer Centers of New York, New York, NY, 3 Dana-Farber Cancer Institute, Boston, MA, 4 Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, 5 Center for Health Quality, Outcomes, and Economic Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, 6 Boston University School of Public Health, 7 Beth Israel-Deaconess Medical Center, 8 Brigham and Women’s Hospital, 9 Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA, 10 Albert Einstein School of Medicine, New York, NY, and 11 Harvard Medical School, Boston, MA, USA

Read the full article

OBJECTIVE
  • To describe a successful quality improvement process that arose from unexpected differences in control groups’ short-term patient-reported outcomes (PROs) within a comparative effectiveness study of a prostate brachytherapy technique intended to reduce urinary morbidity.
PATIENTS AND METHODS
  • Patients planning prostate brachytherapy at one of three institutions were enrolled in a prospective cohort study.
  • Patients were surveyed using a validated instrument to assess treatment-related toxicity before treatment and at pre-specified intervals.
  • Unexpectedly, urinary PROs were worse in one of two standard brachytherapy technique control populations (US-BT1 and US-BT2). Therefore, we collaboratively reviewed treatment procedures, identified a discrepancy in technique, made a corrective modification, and evaluated the change.
RESULTS
  • The patient groups were demographically and clinically similar.
  • In the first preliminary analysis, US-BT2 patients reported significantly more short-term post-treatment urinary symptoms than US-BTpatients.
  • The studies treating physicians reviewed the US-BT1 and US-BT2 treatment protocols and found that they differed in whether they used an indwelling urinary catheter.
  • After adopting the US-BT1 approach, short-term urinary morbidity in US-BT2 patients decreased significantly. Brachytherapy procedures were otherwise unchanged.
CONCLUSION
  • Many procedures in cancer treatments are not evaluated, resulting in practice variation and suboptimal outcomes. Patients, the primary medical consumers, provide little direct input in evaluations of their care.
  • We used PROs, a sensitive and valid measure of treatment-related toxicity, for quality assessment and quality improvement (QA/QI) of prostate brachytherapy. This serendipitous patient-centred QA/QI process may be a useful model for empirically evaluating complex cancer treatment procedures and for screening for substandard care.

Read more articles of the week

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