The psychometric validation of a US English satisfaction measure for patients with benign prostatic hyperplasia and lower urinary tract symptoms

Black, Libby; Grove, Alyson; Morrill, Betsy

doi:10.1186/1477-7525-7-55

Cited by 18 publications

(21 citation statements)

References 17 publications

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“…The PPSM is a 12‐item questionnaire that assesses patient satisfaction with treatment. The US English version of the PPSM has been validated for use in men with BPH (18). For questions 1 to 11, patients respond on a 7‐item scale.…”

Section: Methodsmentioning

confidence: 99%

Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 4-year data from the CombAT study

Montorsi

Henkel²,

Geboers

et al. 2010

International Journal of Clinical Practice

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Summary Objective: To investigate the effect of combination therapy with dutasteride plus tamsulosin compared with each monotherapy on patient‐reported health outcomes over 4 years in men with moderate‐to‐severe lower urinary tract symptoms (LUTS) because of benign prostatic hyperplasia (BPH). Methods: CombAT was a 4‐year international, double‐blind, randomised, parallel‐group trial in men (n = 4844) with moderate‐to‐severe symptoms of BPH and at increased risk of disease progression [age ≥ 50 years, International Prostate Symptom Score (IPSS) ≥ 12, prostate volume ≥ 30 cc, serum prostate‐specific antigen ≥ 1.5 ng/ml to ≤ 10 ng/ml and maximum urinary flow rate 5–15 ml/s with minimum voided volume ≥ 125 ml]. Subjects were randomised to receive 0.5 mg dutasteride, 0.4 mg tamsulosin or the combination once daily for 4 years. The primary endpoint at 4 years was the time to event and proportion of subjects with acute urinary retention or undergoing BPH‐related prostate surgery. Secondary endpoints included the health‐outcomes measures, BPH Impact Index (BII), IPSS question 8 (IPSS Q8) and the Patient Perception of Study Medication (PPSM) questionnaire. Results: At 4 years, combination therapy resulted in significantly superior improvements from baseline in BII and IPSS Q8 than either monotherapy; these benefits were observed from 3 months onwards compared with dutasteride and from 9 months (BII) or 12 months (IPSS Q8) onwards compared with tamsulosin. Also at 4 years, the PPSM questionnaire showed that a significantly higher proportion of patients was satisfied with, and would request treatment with, combination therapy compared with either monotherapy. Conclusions: Combination therapy (dutasteride plus tamsulosin) provides significantly superior improvements in patient‐reported quality of life and treatment satisfaction than either monotherapy at 4 years in men with moderate‐to‐severe BPH symptoms.

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Section: Methodsmentioning

confidence: 99%

Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 4-year data from the CombAT study

Montorsi

Henkel²,

Geboers

et al. 2010

International Journal of Clinical Practice

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“…In addition, the degree to which a patient is bothered by his symptoms becomes a factor in the treatment decision [22]. Therefore, measuring satisfaction with the therapy provides important outcome information from the patient's perspective, related to his or her experience with the therapy [7]. Our results indicate that bladder contractility at baseline is important, because weak bladder contractility was closely associated with treatment outcome as well as with objective and subjective symptoms after high-power KTP laser vaporization.…”

Section: Discussionmentioning

confidence: 76%

“…The Boyarsky score [23], IPSS [24], BPH Impact Index [25] and Patient Perception of Study Medication [7] are the ones most commonly used, and they are validated QoL instruments in BPH studies. One limitation of the current study was that only one questionnaire was used for the assessment of treatment satisfaction.…”

Section: Discussionmentioning

confidence: 99%

“…The main goals for BPH treatment not only include improvement in subjective and objective symptoms but also in patientreported quality of life (QoL) and treatment satisfaction. Therefore, treatment-satisfaction measures with evidence of reliability and validity are needed to evaluate BPH therapies in clinical studies [7], and reduction of disease burden and subsequent improvement in the individual's health-related QoL should factor into treatment decisions for patients with BPH [8].…”

Section: Introductionmentioning

confidence: 99%

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Treatment satisfaction after 1 year high-power potassium-titanyl-phosphate photoselective vaporization of the prostate

Cho

Kim

et al. 2010

Asian J Androl

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To investigate the factors that influence treatment satisfaction after high-power potassium-titanyl-phosphate (KTP) laser vaporization of the prostate, we compared the characteristics between patients who were satisfied and those who were not satisfied. In all, 97 patients aged between 53-82 years (median age 67 years) underwent high-power KTP laser vaporization of the prostate for lower urinary tract symptoms due to benign prostatic hyperplasia. At 12 months postoperatively, 60 patients were satisfied with the treatment, whereas 37 were dissatisfied. Although there were no differences in International Prostate Symptom Score (IPSS) values at baseline, the satisfied group scored better in total IPSS at 1, 3, 6, and 12 months postoperatively (P < 0.05). At baseline, the maximum flow rate (Qmax) was lower in the dissatisfied group and remained low throughout the follow-up period, with the exception of 1 month postoperatively (P < 0.05), compared with the satisfied group. There were no differences in other objective data between the two groups, including post-void residual and the number of voids based on the frequency-volume charts. In a multivariate model, a higher bladder contractility index was associated with a greater likelihood of treatment satisfaction 12 months after high-power KTP laser vaporization (odds ratio 1.024, 95% confidence interval 1.001-1.048, P < 0.05). Patients who were not satisfied following the surgery had a smaller improvement in subjective symptoms and Qmax. In addition, our findings suggest that the relative risk of treatment dissatisfaction following high-power KTP laser vaporization was increased in patients with weak detrusor contractility.

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“…Benign prostatic hyperplasia PPSM (Patient Perception of Study Medication) questionnaire [15] 12 PPSM-global, PPSM-pain, assessment of whether patient would ask doctor for medication…”

Section: Treatment Satisfaction Instruments Identifiedmentioning

confidence: 99%

Treatment Satisfaction Instruments for Different Purposes during a Productʼs Lifecycle

Rofail

Taylor

Regnault

et al. 2011

The Patient: Patient-Centered Outcomes Research

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This review investigates whether the development and implementation of treatment satisfaction instruments during a product's lifecycle are informed by their purpose. A basic literature review was performed between 2000 and 2010 using electronic databases (PubMed, PsycINFO®, and EMBASE) and the keywords 'satisfaction' and 'questionnaire' and 'medication' or 'drug'. Relevant articles were reviewed to extract the following information: type of study; study objectives; treatment satisfaction instrument used; clinical condition/indication; purpose of instrument; development of instrument; association of satisfaction with other endpoint measures; and main results and conclusions. Of 875 abstracts, 80 articles were further considered. Treatment satisfaction instruments were most commonly used in observational studies and interventional clinical trials. The review indicated similarities regarding the development and validation of satisfaction instruments, such as using patient input to derive the items and exploring classical measurement properties specific to the target population. Although some differences were apparent between instruments intended for use in clinical trials and clinical practice (e.g. the approaches used to enable the interpretation of satisfaction scores), the specificities of the implementation of treatment satisfaction during a product's lifecycle were rarely considered. By 'keeping the end in mind', data from treatment satisfaction instruments can help at three key stages: (i) product access to market: generating evidence as part of an overall value proposition to facilitate product reimbursement at a national level; (ii) market access to product: making the product available at a local level (e.g. local hospital formularies); and (iii) clinical practice: enhancing market penetration and product expansion after launch, and demonstrating value for prescribers. Furthermore, the development, validation, and interpretation of scores from treatment satisfaction instruments should be sensitive to the intended purpose. By considering the stage in the product lifecycle when an instrument is to be used, treatment satisfaction instruments can be developed with the specific research purpose and target audience in mind - whether it be patients, payers, or prescribers. In the future, treatment satisfaction instruments will become increasingly important for informing decisions at the individual level, giving patients a voice towards their overall management and care, and enhancing the relationship between doctor and patient.

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The psychometric validation of a US English satisfaction measure for patients with benign prostatic hyperplasia and lower urinary tract symptoms

Cited by 18 publications

References 17 publications

Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 4-year data from the CombAT study

Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 4-year data from the CombAT study

Treatment satisfaction after 1 year high-power potassium-titanyl-phosphate photoselective vaporization of the prostate

Treatment Satisfaction Instruments for Different Purposes during a Productʼs Lifecycle

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