Dusing 2009.

Methods	Randomized controlled trial
Participants	The study location was not provided 101 participants were randomized to the intervention group and 105 participants were randomized to the control group The inclusion criteria were patients at least 18 years of age who were either newly diagnosed or not treated for at least 1 year. Except for hypertension, patients had to be healthy and not requiring any regular long‐term drug treatment (e.g. for asthma, chronic obstructive pulmonary disease (COPD), diabetes, rheumatoid arthritis, pain medication, depression, psychotropic drugs, inflammatory bowel disease, estrogen replacement therapy, thyroid hormones, hypercholesterolemia, and oral contraception)
Interventions	Intervention: MULTIFACTORIAL INTERVENTION The set of supportive measures provided for selected centers and all patients recruited in these centers is listed below. It was up to the patients to select the tools they would like to use on an individual basis. For the patient: (a) 24‐hour timer: the timer can be set to an individual time and provides an acoustic signal every 24 hours at this point of time; (b) Set of 10 reminding stickers to be positioned at prominent places at home (e.g. refrigerator and bathroom mirror); (c) Information brochure for patients with hypertension published by the German Hypertension Society; (d) Information letter for the patient; (e) Information letter the patient can give to next of kin to receive support or his therapy (e.g. spouse reminding of drug intake); (f) Home BP measurement device; (g) Booklet to document home BP measurements Control: STANDARD CARE At the baseline visit, all eligible patients were started on study treatment with valsartan 160 mg daily for 4 weeks. Patients with controlled BP were continued on treatment with valsartan 160 mg. Patients not achieving BP values less than 140/90 mm Hg by week 4 were then uptitrated to valsartan 160 mg and hydrochlorothiazide (HCTZ) 12.5 mg as a fixed‐dose combination. Follow‐up visits were scheduled after 2 (3rd visit), 4 (4th visit), 8 (5th visit), 14 (6h visit), 24 weeks (7th visit), and at the end of the observation period at 34 weeks (8h visit). Dispensing of the study drugs was as follows. At baseline, patients received MEMS bottles containing 48 tablets of 160 mg valsartan. At 4th and 5th visits, that is, after 4 and 8 weeks, patients received further MEMS bottles containing 48 tablets of either 160 mg valsartan or 160 mg valsartan and 12.5 mg of HCTZ depending on their BP. At the 6th and 7th visits, that is, after 14 and 24 weeks of treatment, patients received MEMS bottles containing 76 tablets. Patients were instructed to take their medication per mouth with water in the morning between 0700 and 1100 hours, regardless of meals. No supportive measures were given to patients
Outcomes	The measures of adherence were electronic MEMS, which compiled date and time of drug intake through the opening of the medication bottle for every day. The MEMS monitors were drug containers designed to compile the dosing history of ambulatory patients prescribed oral medications. Each monitor consisted of a conventional medicine bottle filled with a special closure that recorded the time and date of each opening and closing of the container through integrated microcircuitry. Monitors were designed to be used by one patient with one drug. A communicator transferred the dose‐timing data from the MEMS monitor to a computer. At the 2nd and 6th visits, MEMS monitors were to be provided for all patients. At the 6th and 8h visits, the monitors used by the patients were collected by the investigator for data analysis The patient outcomes were blood pressure response and normalization in the 2 randomized groups
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No mention of randomization methods. (pg 895) "...cluster‐randomized (by center), open‐label, multicenter parallel‐group study... Centers were assigned to one of the following two treatment arms in a ratio of 1 : 1, centers providing their patients with supportive measures and centers not providing their patients with supportive measures. To avoid any investigator bias in treating one patient with and another patient without supportive measures, investigators rather than patients were randomized to provide only treatment with or without supportive measures for all patients at a single participating center."
Allocation concealment (selection bias)	Unclear risk	No mention of allocation concealment. (pg 895) "...cluster‐randomized (by center), open‐label, multicenter parallel‐group study... Centers were assigned to one of the following two treatment arms in a ratio of 1 : 1, centers providing their patients with supportive measures and centers not providing their patients with supportive measures. To avoid any investigator bias in treating one patient with and another patient without supportive measures, investigators rather than patients were randomized to provide only treatment with or without supportive measures for all patients at a single participating center."
Selective reporting (reporting bias)	Unclear risk	None detected but protocol not available
Other bias	Unclear risk	No clear other biases and no limitations mentioned in article
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) MEMS ‐ Outcome not likely to be affected by outcome assessors
Blinding of outcome assessment (detection bias) Patient outcome	Unclear risk	(PRIMARY) BLOOD PRESSURE AND NORMALIZATION ‐ Method of data collection not detailed in the article and no mention of blinding
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) MEMS ‐ Patients aware of intervention and the measure
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) BLOOD PRESSURE AND NORMALIZATION ‐ Patients not being blinded is unlikely to affect this outcome
Blinding of personnel (performance bias) Adherence measure	Low risk	(PRIMARY) MEMS ‐ It seems other staff were blind. (pg 896) "The centers providing standard care were blinded with regard to the content of the 'supportive measures'"
Blinding of personnel (performance bias) Patient outcome	Low risk	(PRIMARY) BLOOD PRESSURE AND NORMALIZATION ‐ Other staff were blinded. (pg 895) "The centers providing standard care were blinded with regard to the content of the 'supportive measures'." Also, open‐label but cluster RCT and objective outcome
Incomplete outcome data (attrition bias) Adherence measure	Unclear risk	(PRIMARY) MEMS ‐ Uneven loss to follow‐up and not all reasons for dropout are clear; adverse events was one reason for dropouts
Incomplete outcome data (attrition bias) Patient outcome	Unclear risk	(PRIMARY) BLOOD PRESSURE AND NORMALIZATION ‐ Uneven loss to follow‐up and not all reasons for dropout are clear; adverse events was one reason for dropouts